ML20134M009

Responds to 910619 SRM That Approved Final Quality Mgt Program & Misadministrations Rule & Directed Staff to Assess Effectiveness of Rule 3 Yrs After Rule Became Effective

ML20134M009
Person / Time
Issue date:	02/12/1997
From:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-97-037, SECY-97-037-R, SECY-97-37, SECY-97-37-R, NUDOCS 9702200057
Download: ML20134M009 (208)

Text

o seeeeeeeeeeeee .eeeeeeee POLICY ISSUE (Information) l February 12, 1997 SECY-97-037 FOR: The Commissioners FROM: Hugh L. Thompson, Jr.

Acting Executive Director for Operations

SUBJECT:

ASSESSMENT OF THE QUALITY MANAGEMENT PROGRAM AND MISADMINISTRATIONS RULE PSDO5E To responc to a Staff Requirements Memorandum (SRM) dated June 19. 1991, that approved the final Quality Management Program and Misadministrations Rule (OM Rule) and directed the staff to assess the effectiveness of the rule three years after the rule became effective including recommendations on the need for a rulemaking on comprehensive quality management.

SUMMARY

In SECY-93-244. dated August 31. 1993. the staff proposed to include status reports on the implementation of the OM Rule in its proposed plan for management of the medical use regulatory program. This plan addressed major policy issues associated with the medical use program.

On October 13. 1994, in SECY-94-256, the staff provided a status report on the medical management plan, including the implementation progress of the OM Rule.

At that time. the staff recommended that no changes in the scope nor CONTACT: Sally L. Merchant. NMSS NOTE: To BE MADE PUBLICLY AVAILABLE IN (301) 415-7874 5 WORKING DAYS FRoM THE DATE OF THIS PAPER kh r I

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The Commissioners 2 ,

focus of the rule be initiated until: further data was collected regarding  !

the adequacy of the implemented quality management program (OMP) during -

inspections; a determination of the root causes of misadministrations was  !

made: violations of the OM Rule were identified; and collection and analysis '

of licensee data regarding the number of procedures performed requiring ,

written directives were completed.  ;

This report was developed to compile and correlate the findings associated  ;

with the review of the written OMPs, and inspection of licensee's  ;

implementation of those OMPs. It provides a preliminary analysis that enables  !

the staff to assess the im)lementation of the OM Rule and to respond to the l

question provided in the SIM dated June 19, 1991. regarding the need for a  !

l rulemaking on comprehensive quality management. The staff intends to use this  !

l report as part of the effort to revise 10 CFR Part 35, and to provide l recommendations on any changes to OM requirements in the context of that revision.

DISCUSSION:

l On August 1.1994, the revised Temporary Instruction (TI) (2800/025). " Quality 1 Management Program and Misadministration Rule." became effective. This TI j established areas of inspection, created a procedure for determining -

compliance with the rule, and provided a means of recording the inspection findin?s for later analysis. The TI was in effect until August 1. 1996. The i

resulting inspection results were analyzed to address the Commission's ,

! direction for assessing the effectiveness of the rule. The attached report: .

" Assessment of the Implementation of the Quality Management Program and '

Misadministrations Rule. 10 CFR 35.32 and 35.33." is submitted to respond to  !

the SRM dated June 19, 1991. In addition, the staff intends to publish this I report as a NUREG to provide information on the OM Rule to the regulated i l community and the public. Members of the regulated community and associated i

professional societies have expressed an interest in such information.

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l FINDINGS:

l l A total of 883 licensees, representing 1668 modalities, were inspected during I the two years the TI was in effect. Seventy-seven percent (1286) of the inspected OMPs had previously been reviewed by Lawrence Livermore National i Laboratories (LLNL) during the initial review of written submittals. During l ins)ection, the implemented OMP was compared to the requirements in the rule, i ratier than to the submitted written OMP. Review of inspections findings for l licensees' OMPs indicates that 43 percent of the OMPs failed to meet all of l the objectives of the rule.

There has not been a significant reduction in the total number of misadministrations reported, the performance indicator most closely linked to OM Rule effectiveness. While the number of reports of diagnostic misadministrations has been significantly reduced due to changes in requirements as to what incidents must be reported, the net number of reported therapy misadministrations remains at approximately 30 to 40 per year. 1 However, the distribution of errors that led to misadministrations, per l l l

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.. i The Commissioners 3 modality, has changed. For example, strontium-90 eye applicator events have ;

increased significantly. An ongoing investigation involving eye applicators is expected to add at least two more misadministrations, each involving multiple patients, to the database. i The staff examined the relationship between routine inspection findings, and  !

reactive inspection findings associated with misadministrations. For those  :

licensees who had a misadministration at some time since the rule became i effective, only 29 percent had an inspection finding related to QMP  !

implementation during their routine inspection. However, in 56 cases (45 percent of 138 misadministrations) the staff took enforcement actions related to some aspect of the OMP during the follow-up relating to the ,

misadministration. Therefore, routine inspection findings are not necessarily '

predictors of the probability of the occurrence of a misadministration, and .

there is a better, although not a strong, correlation between the occurrence of a misadministration and an inspection finding related to the OM program at the time of the event. '

In 1991, the causes of misadministrations and/or abnormal occurrences were -

characterized in the Statements of Consideration, published with the final QM  !

Rule, as: insufficient supervision, deficient procedures or failure to follow i 3rocedures, inattention to detail, and inadequate training. Since the OM Rule 3ecame effective these same causes of misadministrations appear to persist.  ;

However, most of the current errors can be attributed to two of the causes:

inattention to detail and failure to follow procedures, both of which may be .

viewed as " human errors" as contrasted to " mechanical errors." The most i frequent causes of the misadministrations reported to NRC since  ;

January ~27, 1992, were as follows: 1 26 involved incorrect data entry and calculation errors.  ;

23 involved wrong source, radiopharmaceutical or dose (quantity), -

18 involved the wrong treatment site, 10 involved source migration /dislodgement.

6 involved failure to administer the entire dose or dosage (the source or dosage (capsule) was left in the pig or tandem).

Many of the above errors that led to a misadministration could have been i prevented by: (1) redundantly checking the data entry and calculations (OM Objective 3), or (2) immediately before administering the dose or dosage,  !

comparing that which was to be administered to the written directive (QM '

Objective 4). Thus, with the exception of equipment failures and certain source migration /dislodgement events, it would appear that more complete adherence to meeting the objectives in the OM Rule should reduce the likelihood of a misadministration.

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l l CONCLUSION:

l l Based on the four-year implementation of the OM Rule, the staff has concluded l that the expansion of the current OM Rule into a comprehensive quality

management program is not needed. Specific recommendations regarding proposed i

changes to the OM Rule will be provided in the staff's rulemaking plan for revision of 10 CFR Part 35.

COORDINATION:

l The Office of the General Counsel has no legal objection to this paper.

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Attachment:

QM Rule Assessment I

DISTRIBUTION: l Commissioners OGC OCAA DIG oPA l

oCA EDo SECY 1

4 ASSESSMENT OF THE IMPLEMENTATION OF THE QUALITY MANAGEMENT  ;

PROGRAM AND MISADMINISTRATIONS RULE 10 CFR 35.32 AND 35.33 l

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Contact:

Sally L. Merchant, NMSS (301)415-7874 ATTACHMENT 1

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4 CONTENTS EXECUTIVE

SUMMARY

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REPORT: l Introduction 1 i History 2  ;

Review of OMPs 4 l Inspection of OMPs 5 Findings 6 Events 9 Enforcement 10 Summary / Conclusion 11 REVIEW FINDINGS: 13 SODIUM IODIDE 14 RADIOPHARMACEUTICAL THERAPY 20 HIGH-DOSE-RATE AFTERLOADER (HDR) 26 BRACHYTHERAPY 34 STRONTIUM-90 EYE APPLICATOR 42 TELETHERAPY 47 GAMMA STEREOTACTIC RADIOSURGERY 55 DATA TABLES:

SUMMARY

DATA: 62 INSPECTION FINDINGS 63 i

ENFORCEMENT DATA (MISADMINISTRATIONS) 64 SODIUM IODIDE 65 RADIOPHARMACEUTICALTHERAPY 67 HIGH DOSE RATE AFTERLOADER (HDR) 69 BRACHYTHERAPY 71 STRONTlUM 90 EYE APPLICATOR 73 TELETHERAPY 75 ,

GAMMA STEREOTACTIC RADIOSURGERY 77 j ATTACHMENTS l

1. Standard Review Plan

2. Regulatory Guide 8.33,

" Quality Management Program" ,.

3. Table 1: "Results Summary- All Regions," -

Findings of LLNL Review

4. Temporary instruction (TI) (2800/025) l

" Quality Management Program and Misadministration Rule"

5. Table of Misadministrations L_--_--_ - - _ - . . _ _ . - - - . _ . - - - _ - -

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EXECUTIVE

SUMMARY

l QUALITY MANAGEMENT PROGRAM AND MISADMINISTRATIONS RULE l

l In June 1991, where the final Quality Management Program (QMP) and Misadministrations  ;

Rule (QM Rule),10 CFR 35.32 and 35.33, was approved, the Commission directed the staff to assess the effectiveness of the QM Rule three years after the rule became (

effective, and provide recommendations on the need for a rulemaking on comprehensive j 2

quality management. This report responds to that directive.

The QM Rule became effective on January 27,1992. The rule requires licensees that administer therapeutic quantities of byproduct material and diagnostic quantities of greater ,

than 30 microcuries of radioactive sodium iodide to develop and implement a OMP to l

' ensure that byproduct material or radiation from byproduct material is administered as I directed by an authorized user. It requires that on, or before the effective date, each existing licensee, as applicable, submit a copy of its OMP_ and written certification that the program had been implemented to the appropriate U.S. Nuclear Regulatory Commission regional office.

A portion of the QM Rule,10 CFR 35.32(a), requires licensees to establish and maintain a l QMP that meets five objectives: (1) a written directive for each administration must be l prepared, containing information specific to each modality (listed in 10 CFR 35.2,

" Definitions"), dated and signed by an authorized user physician; (2) the patient or {

research subject's identity must be verified, using more than one method, as the individual t named in the written directive; (3) final plans of treatment and related calculations must be l in accordance with the written directive; (4) administration must be in accordance with the written directive; (5) any unintended deviation from the written directive must be identified and evaluated, and that appropriate action must be taken. Additional requirements are .

listed in 10 CFR 35.2, and in 35.32(b) through (f), including a requirement to develop ,

procedures for and conduct a review of the QMP at intervals of no greater than 12 months. 'l i

In July 1993, Lawrence Livermore National Laboratory (LLNL) was contracted to review ,

i the licensee-submitted QMPs. Of the total,2 percent of the submitted QMPs appeared to meet the requirements of 10 CFR 35.32; 16 percent appeared to meet the objectives, but  ;

appeared to have weaknesses; 72 percent of the submitted QMPs failed to fully meet one or more of the objectives; and ten percent acknowledged receipt of negative declaration letters stating they would not use the material until a QMP for that modality had been ,

submitted.

On August 1,1994, a revised Temporary instruction (TI) (2800/025)," Quality Management Program and Misadministration Rule," (Attachment 4) became effective. The revised Tl established areas of inspection and created a procedure fordetermining compliance with the QM Rule. This Tl was in effect until August 1,1996.

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i The number of Tl Field Notes provided for data entry were 883, and the number of 1 modalities represented on all submitted Tis was 1903. Si:v:e 235 modalities were inspected'twice, the population for this analysis is 1668 modtlities. This adjustment allows comparison between the results of the review of the wrnten submittal and the implementation of the QMPs assessed during inspection.

The review of the Tl found that 8 percent of inspected QMPs did not meet Objective 1.

Most missed the Objective because the contents of the written directive did not meet the requirements in 10 CFR 35.2, " Definitions."

Three percent of inspected QMPs did not meet Objective 2. However, only 3 i J

misadministrations reported to NRC since January 27,1992, were caused by selection of the wrong patient. This compares f avorably with the total of 11 misadministrations caused by administrations to the wrong patient for years 1989 and 1990.

Eleven percent of inspected QMPs failed to implement procedures to meet Objectives 3, and 9 percent of inspected QMPs did not meet Objective 4. One hundred and three of the l misadministrations reported to NRC since January 27,1992, involved a violation of either Objective 3 or 4.

For Objective 5,18 percent of modalities did not implement procedures to meet the requirement. In addition,12 percent of applicable licensees did not perform a review of their program within each 12-month period, and an additional 29% performed a 12-month review of their QMP that did not meet the requirements. The reason for this level of non-compliance is not clear. 1 There has not been a significant reduction in the total number of misadministrations, the

- performance indicator most closely linked to this issue due to changes in the requirements ,

I of what must be reported. While the number of reports of diagnostic misadministrations has been significantly reduced, the net number of therapy misadministrations remains at approximately 30 to 40 per year, However, the distribution of errors that led to l

misadministrations, per modality, has changed. For example, strontium-90 eye applicator events have increased significantly. An ongoing investigation involving eye applicators is expected to add at least two more misadministrations, each involving multiple patients, to the database.

The staff examined the relationship between routine inspection findings and reactive inspection findings associated with misadministrations. For those licensees who had a misadministration at some time since the rule became effective, only 29 percent had an inspection finding related to QMP implementation during their routine inspection. However, in 56 cases (45 percent of 138 misadministrations), the staff took enforcement actions related to some aspect of the QMP during the follow-up relating to the misadministration.

Therefore, routine inspection findings are not necessarily predictors of the probability of the occurrence of a misadministration, and there is a better, although not a strong, correlation  ;

between the occurrence of a misadministration, and an inspection finding related to the QM program at the time of the event.

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! l l 1 1 1 INTRODUCTION i

l The Quality Management Program (OMP) and Misadministrations Rule (OM Rule),

10 CFR 35.32 and 35.33, became effective on January 27,1992. The rule required liconaees that administer therapeutic quantities of byproduct material and diagnostic quantities of greater than 30 microcuries of radioactive sodium iodide to develop and implement a OMP to ensure that byproduct material or radiation from byproduct material

would be administered as directed by an authorized user, it required that on, or before the l effective date, each existing licensee, as applicab!s, must submit a copy of their QMP and written certification that the program had been implemented to the appropriate U.S.

Nuclear Regulatory Commission regional office.

The rule modified the notification, reporting, and record-keeping requirements related to misadministrations. In addition, the rule revised the definition for " misadministration" in 10 CFR 35.2, " Definitions," and distinguished between "misadministrations" and lesser

" recordable events" for which reporting to the NRC is not necessary. This revision resulted in a greater than 10-fold reduction in the number of incidents that must be reported to

NRC. Prior to this rule, errors in administration that met the, then, current l misadministration criteria averaged more than 400 per year. This reduction resulted from two significant changes

(1) elevation of the reporting threshold for diagnostic misadministrations to 5 rem total effective dose equivalent and 50 rem effective dose equivalent to individual organs; and (2) essentially doubling the threshold for therapeutic misadministrations. The previous threshold (10 percent) became the threshold for a recordable event.

An additional modification was made to 10 CFR 35.25 " Supervision," which now requires supervised individuals to be instructed in the licensee's OMP, as appropriate to that individual's use of byproduct material.

A portion of the OM Rule,10 CFR 35.32(a), requires licensees to establish and maintain a OMP that meets five objectives: (1) a written directive for each administration must be prepared, contaiGji information specific to each modality (listed in 10 CFR 35.2,

" Definitions"), dated and signed by an authorized user physician: (2) the patient or research subject's identity must be verified,using more than one method, as the individual named in the written directive; (3) final plans of treatment and related calculations must be in accordance with the written directive; (4) administration must be in accordance with the l written directive; (5) any unintended deviation from the written directive must be identified '

and evaluated, and appropriate action taken. Additional requirements are listed in 10 CFR '

35.2, and in 35.32(b) through (f), including a requirement to develop procedures for and conduct a review of the OMP at intervals of no greater than 12 months.

The rule requires licensees to submit their wntten OMPs to NRC for review. However, NRC made a decision before the rule was promulgated, not to add the specific OMP to the license as a license condition referencing a licensee submitted document (i.e., " tie-down" condition). This allows the licensee the flexibility to make modifications to the OMP as the licensee deems necessary, consistent with 10 CFR 35.32(e).

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O in June 1991, when the final OM Rule was approved, the Commission directed the staff to assess the effectiveness of the Quality Management Program and Misadministrations rule (QM Rule) three years after the rule became effective, and provide recommendations on the need for a rulemaking on comprehensive quality management. This report responds to that directive.

HISTORY On October 2,1987, NRC published a proposed prescriptive rule on quality assurance (QA) as directed by the Commission. Its objective was to reduce the number of errors in i therapeutic administrations of radiopharmaceuticals or radiation from byproduct material and the administration of radioactive iodine. Public comments on the proposed rule indicated that the imposition of prescriptive requirements would interfere with the practice of medicine, because it did not afford sufficient flexibility for clinical practice. NRC's Advisory Committee on Medical Uses of Isotopes suggested that a performance-based rule should be promulgated, rather than a prescriptive rule. On June 3,1988, the Commission directed the staff to develop a performance-based rule and regulatory guide, conduct a pilot program, and review and possibly revise the definition of a misadministration.

The proposed rule, published on January 16,1990, contained amendments that would require Part 35 licensees to establish and implement a basic QA program. In addition, it provided modifications to the definition for " misadministration" and the associated reporting and record keeping requirements.

In 1990, NRC conducted a pilot program to provide a "real-world" test of the proposed rule in licensee hospitals and clinics. Five 1-day workshops were held, one in each NRC region, to explain the over-all process for the pilot program and to discuss the proposed rule and draft guidance. Sixty-four institutions participated in the pilot study,23 NRC and 41 Agreement State licensees. Following the workshops, licensees developed a QA program following the objectives proposed, and implemented the programs for 60 days. During the 60 days, NRC reviewed all of the written QA programs, and visited 18 of the irt,olemented programs. At the end of the pilot program, five 2-day workshops were held to discuss problems with and recommendations for the proposed rule. The findings of the pilot program supported developing a performance-based rule. In addition, the findings suggested that QA programs, as implemented, were found to be more complete than applicable written programs. Most findings of the pilot were adopted in developing the final rule. A report on the pilot program was published with the final rule.

The final rule was published on July 25,1991, to be effective on January 27,1992. It '

contained numerous substantive changes as compared to the proposed rule. The most significant changes included:

1. A change in the name of the rule from " quality assurance" to " quality management," to avoid confusion or interference with the thousands of existing, hospital-wide, QA programs.

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2. Elevation in the threshold for diagnostic misadministrations to 5 REM TEDE and 50 REM effective organ dose.

3. Changes in the definitions (10 CFR 35.2) for misadministrations for all modalities of medical use.

On December 24,1991, NRC submitted an information collection requirements (ICR) approval request to the Office of Management and Budget (OMB), for the OM Rule which would be effective in January 1992. In communications with OMB, the American College of Nuclear Physicians and Society of Nuclear Medicine (ACNP/SNM) expressed strong opposition to the rule in June 1992, OMB disapproved the record collection requirements of the rule. The NRC Commissioners, finding that public health and safety warranted institution of the ICR, overrode the OMB determination.

In an additional action, in February 1992, the ACNP/SNM filed a petition for review of the rulemaking, with the U.S. Court of Appeals in Washington, DC in American Colleae of Nuclear Physicians and Society of Nuclear Medicine v. U.S. Nuclear Reaulatory Commission. Only ten days after hearing arguments in the case, the court ruled in favor of the NRC, declaring that it saw "no need for a published opinion." 976 F.2d 45 (D.C. Cir.

1992)(Table). The court stated:

- On the record before us, we find no basis to overturn the OM Rule; accordingly, the petition for review is hereby denied, substantially for the reasons stated by the NRC i in its rulemaking. The NRC,in promulgating the OM Rule, acted within the bounds of its broad statutory mandate to establish "such standards ... as the Commission 4 may deem necessary or desirable to ... protect health or to minimize danger to life  !

and property." 42 U.S.C. I 2201(b)(West Supp.1992)(emphasis added).

Moreover, the substantive requirements imposed by the OM Rule are not " arbitrary, 4 capricious, an abuse of discretion, or otherwise not in accordance with the law." 5

. U.S.C. I 706(A) (1988).

In response to ACNP concerns, NRC held a public meeting on November 9,1992,to meet publicly with the medical community and other interested paries to ensure a mutual

. understanding of the intent of the OM Rule, and to clarify the information collection requirements associated with the rule. As part of the meeting, the ACNP provided a presentation about its self-auditing guidelines.

In a letter dated November 28,1995,in response to NRC's 1995 application to OMB for renewal of approval for the ICR associated with the OM Rule, the ACNP/SNM again requested that OMB disapprove the ICR associated with 10 CFR 35.32 and 35.33. The staff addressed the ACNP/SNM's concerns as part of its submission to OMB requesting continued authorization for the ICR. Subsequently,in February 1996, OMB approved the ICR for a 1-year period.

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j REVIEW OF WRITTEN OMPS

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CONTRACTUAL SUFPORT FOR REVIEW OF SUBMITTED QMPS l 1

- In June 1992, proposals were sought to obtain contractor support to assist the t,taff in ,

reviewing the submitted OMPs. The effort included a combination of: performing reviews l of the approximately 1700 OMPs submitted by the licensees: preparing letters to licensees that pointed out weaknesses and/or omissions in the submitted OMPs, and preparing a l letter to sach licensee describing the findings of the individual review. In addition, the j contract required the contractor to conduct a " pilot" program to compare the submitted  ;

written OMP with the implemented OMP in 10 applicable licensees' facilities. Lawrence Livermore National Laboratory (LLNL) was the only one to provide a proposal; it was I awarded the contract in July 1993.

in September 1993, LLNL and NRC completed the " pilot" program that compared )

submitted written OMPs with the implemented OMPs in a small sample of licensees' i facilities. Ten programs were selected based on location (Regions I and lil) and inspection j cycle (inspections due). An inspection team, consisting of regional inspectors, the OM coordinator from NRC's Headquarters, and the contractor, visited each facility to review the programs. In 9 of the 10 facilities visited, the implemented programs were found to #

better meet the requirements of the OM Rule than those of the submitted written i programe. However, in the 1 case, a " broad-scope" licensee, the written program did not meet the five objectives listed in the rule, nor was an adequate program implemented. This ' ,

limited sanoling reinforced the staff's belief that many licensees implemented more l complete progicms than were documented in their submitted OMPs. This finding  ;

supported similar resuits from the earlier pilot program NRC conducted to provide a real world test of the proposed rule (findings published with final rule, July 25,1991). .

i The 1993 NRC/LLNL pilot program also provided an opportunity for the staff, along with i the contractor, to evaluate the procedures used by NRC inspectors in evaluating licensees' l implementation of their OMP.  :

Review of NRC Licensee's Submitted QMP  !

i A standard review plan (SRP) and checklist for the review of written OMPs were developed by the staff (Attachment 1). The information contained in Regulatory Guide 8.33, " Quality Management Program" (Attachment 2) was used as a general guideline in developing these review documents. The actual reviews were conducted by LLNL staff and physicians, medical physicists, dosimetrists, and technologists on the medical staff at the University of ,

California, San Francisco Medical Center. LLNL maintained a database of findings, and  :

generated draft letters to licensees that conveyed the findings of the review to NRC's regional staff.

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Communication of Review Findinas to Licen====

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In April 1994, LLNL began providing the NRC regional offices with draft letters, addressed j to licensees, outlining LLNL's findings from the review of the licensees' OMPs. Regional t staff finalized and dispatched the letters to the licensees.

l l The letters were divided into four categories.

l Type 1: OMP appears to meet the requirements of 10 CFR 35.32;

, Type 2: OMP inadequate due to omissions or weaknesses in the program; ,

l Type 3: Written OMP failed to meet at least one of the objectives: '

Type 4: A response letter to those facilities that had submitted a negative l declaration (applicable material was not in use at their facility).

The total number of letters sent to licensees was 1709. The types of letters included:

2 percent of the submitted OMPs appeared to meet the requirements of 10 CFR 35.32; 16 percent appeared to meet the objectives, but appeared to have weaknesses: 72 percent of the submitted OMPs failed to fully meet one or more of the objectives; and ten percent acknowledged receipt of negative declaration letters stating they would not use the ,

l material until a OMP for that modality had been submitted. Table 1: "Results Summary- 1 All Regions," (Attachment 3) outlines the LLNL findings for each modality of use.

i LLNL provided the following "brief summary" of the findings of the review of the originally submitted written OMPs: )

1 Average percentages of missino any aspects of the objectives and other requirements: '

Objective 1: 83%

Objective 2: 4%

Objective 3: 64 % ,

Objective 4: 39%

Objective 5: 57 %

Recordable Events: 70%

l Annual Review: 93%

INSPECTION OF IMPLEMENTED OMPS:

On August 1,1994, a revised Temporary Instruction (TI) (2800/025)" Quality Management Program and Misadministration Rule," became effective. The revised Tl established areas of inspection and created a procedure for determining compliance with the rule. The inspection emphasis for this Tl was directed at the licensee's implemented program for: 1) assuring that administration of applicable material was as directed by a physician authorized user, and 2) identification, evaluation, and correction of deficiencies to prevent i recurrence. Inspectors were instructed to include inspection of OM programs with all l routine inspections of applicable facilities. This Tl was in effect until August 1,1996.

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l Data, collected through the Tl Field Notes, were saved for analysis to determine the  ;

effectiveness of the OM Rule, and to aid the staff in responding to the Commission's '

directive to analyze the implementation of the OM Rule three years after the effective date. i The NRC staff has conducted an analysis of the OMP data, collected by several NRC 1 Offices, from February 1,1992, to August 1,1996. Databases used in the analysis of this  !

data included: the LLNL database of written OMP data; the Tl inspection database; the Licensing Tracking System; the inspection Follow-up System; The Office of Enforcement Database; and the Nuclear Materials Event Database. The databases were managed using

" Access," an off-the-shelf, relational database management system made by Microsoft Corporation.

i There may be discrepancies observed in the data used in the analysis of misadministrations and enforcement actions when compared with some other NRC data collections. This discrepancy exists because criteria for data collected in the various databases differ, based

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on the needs of the various end-users. 1 The number of Tl Field Notes provided for data entry was 883, and the number of modalities represented on all submitted Tis was 1903. Since certain modalities are inspected on a 1-year frequency,235 modalities were inspected twice. Nine of the 235 QMPs that were previously inspected failed to meet an objective or requirement that they

'had met on the first inspection. '/ifty-seven of the 235 OMPs that had been previously inspected showed improvement. Specific findings of these second inspections were not included in the analysis. Therefore, the population for this analysis is 1668 modalities.

This adjustment allows comparison between the results of the LLNL review of the written submittal, and the implementation of the OMPs assessed during inspection.

In addition, LLNL had not reviewed the written OMPs of 58 of the inspected OMPs, representing 382 modalities. Reasons why these OMPs were not included in the LLNL review in 1993 include: new licenses that were subsequently issued, the addition of modalities to a license that did not previously require a OMP, and files missing from the regional file storage area because of licensing, inspection, and/or enforcement actions.

OMPs that were not reviewed by LLNL were reviewed by NRC staff, using the same OM Standard Review Plan.

i INSPECTION FINDINGS: l Licensee's OMPs must include written policies and procedures to meet the following ,

objectives that are listed in 10 CFR 35.32(a). Since this requirement is performance-based, licensees may follow the suggestions for procedures that are contained in Regulatory Guide 8.33, " Quality Management Program" (Attachment 2), or implement their own procedures.

Obsective 1: A written directive for each administration must be prepared, containing information specific to each modality (listed in 10 CFR 35.2, " Definitions"), dated and signed by an authorized user physician.

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T The percentage of licensees that did not implement procedures which met Objective 1

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Sodium lodide > 30 microcuries 6%

Radiopharmaceutical therapy 10 %

High-Dose-Rate Afterloading

Brachytherapy 6%

Brachytherapy 4%

Strontium-90 eye Applicators 16%

. Teletherapy 15% i Gamma Stereotactic Radiosurgery 0 Teletherapy and Strontium-90 Eye Applicators failures appear high because of the small number of Tis (and licensees) for this modality.

Obiective 2: The patient or research subject's identity must be verified using more than one method, as the individual named in the written derective.

l The percentage of licensees that did not implement procedures which met Objective 2  !

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i Sodium lodide > 30 microcuries 1%

Radiopharmaceutical therapy 7%

4 High-Dose-Rate Afterloading Brachytherapy 2%

i Brachytherapy .4%

Strontium 90 eye Applicators O

- Teletherapy 3%

Gamma Stereotactic Radiosurgery 0 Obiective 3: That final plans of treatment and related calculations are in accordance with the written directive.

Licensees that did not implement procedures which met Objective 3:

Sodium lodide > 30 mictocuries Not applicable Radiopharmaceutical therapy Not applicable

High-Dose-Rate Afterloading i Brachytherapy 3%

Brachytherapy 5% l Strontium-90 eye Applicators 14% I Teletherapy 41 %

Gamma Stereotactic Radiosurgery (1 of 4 did not meet)

N 7

4 I

_ _ . . _ _ _ . _ . ~ . . . . _ . . _ _ . _ . . . _ . _ . _ . . ~ _ . . - . _ _ . _ . _ . - - _ _ . _ _ _ . _ _ _ . ~ _ _ _ _ . _ _

1 i Obmetive 4: That administration is in accordance with the written directive.

Licensees that did not implement procedures which met Objective 4:

Sodium lodide > 30 microcuries 7%

Radiopharmaceutical therapy 11 %

High-Dose-Rate Afterloading Brachytherapy 6%

Brachytherapy 5%

Strontium-90 ye Applicators 18 %

Teletherapy 14%

Gamma Stereotactic Radiosurgery (1 of 4 did not meet) i i

Obiective 5: That any unintended deviation from the written directive is identified and evaluated, and that appropriate action is taken.

Licensees that did not implement procedures which met Objective 5: 1 Sodium lodide >30 microcuries 16%

Radiopharmaceutical therapy 21 %  :

High-Dose-Rate Afterloadirq l Brachytherapy 20 % i Brachytherapy 13 %

Strontium-90 ye Applicators 22%

Teletherapy 15%

Gamma Stereotactic Radiosurgery (1 of 4 did not meet) ,

J The review of the Tl found that, for a total of all modalities, the percentage of objectives or  :

requirements that were not met included: l l

Seven percent of inspected OMPs did not meet Objective 1. Most missed the Objective because the contents of the written directive did not meet the requirements in  ;

10 CFR 35.2, " Definitions." i i

Three percent of inspected OMPs did not meet Objective 2. However, only 3 misadministrations reported to NRC since January 27,1992, were caused by selection of the wrong patient. This compares favorably with the total of 11 misadministrations caused j by administrations to the wrong patient for years 1989 and 1990.

Eleven percent of inspected OMPs failed to implement procedures to meet Objectives 3, and 9 percent of inspected OMPs did not meet Objective 4. One hundred and three of the misadministrations reported to NRC since January 27,1992, involved violations of Objectives 3 or 4.

l 8

l

For Objective 5,18 percent of modalities did not implement procedures to meet the requirements. In addition,12 percent of applicable licensees did not perform a review of thair programs within each 12-month period, and an additional 29 percent performed 12-month reviews of their QMPs that did not meet the requirements. The reason for this level i

of non-compliance is not clear. Page 63 contains a table of the inspection findings which clarifies this data.

d i Comoarison of Insoection of Imolemented QMPs with Reviewed Written QMPs:

J Drawing from the same population of inspected licensees, the following are percentages of implemented OMPs that missed objectives or requirements, compared with written OMPs as reviewed by LLNL:

_TI LLNL Objective 1 8% 41 %

Objective 2 3% 36%

Objective 3 11 % 60 %

Objective 4 9% 37 %

Objective 5 18 % 50 %

12 mo. review 29 % 43%

of OMP The table above demonstrates that licensees appear to implement OMP that more closely

, meet the requirements in the rule then do their written QMP. A total of 883 licensees, i representing 1668 modalities, were inspected during the two years the Tl was in effect. 1 Seventy-seven percent (1286) of the inspected QMPs had previously been reviewed by Lawrence Livermore National Laboratories (LLNL) during the initial review of written submittals. Dunng inspection, the implemented OMP was compared to the requirements in the rule, rather than to the submitted written OMP. Review of inspections findings fer licensees' OMPs indicates that 43 percent of the OMPs failed to meet all of the objectives ,

of the rule. l l

MISADMINISTRATIONS AND EVENTS:

1 Since the January 1992 effective date of the OM Rule, there have been 138 misadministrations that met the criteria described in 10 CFR 35.2, " Definitions," involving i one hundred and twenty-five NRC licensees, reported to NRC. The majority of the errors involved brachytherapy procedures (40 manual and 18 High-Dose-Rate); followed by administrations of greater than 30 microcuries sodium iodine (28); teletherapy (23); I radiopharmaceutical therapy (12); and strontium-90 eye applications (4). Some of these 9

d

4

- t incidents involved multiple patients. l The most frequent causes of the misadministrations reported to NRC since January 27, 1992, were as follows: l l

26 involved incorrect data entry and calculation errors, '

23 involved wrong source, radiopharmaceutical, or dose (quantity), '

18 involved the wrong treatment site, 10 involved source migration /dislodgement, j 6 involved failure to administer the entire dose or dosage (the source or dosage j (capsule) was left in the pig or tandem),  ;

i in addition, there were 14 incidents involving patient intervention / source migration.- The l OM Rule is silent on patient intervention. However, this issue has been viewed by the staff as a mitigating factor in determining if events are, in fact, misadministrations. This is consistent with the 10 CFR Part 35 " Statements of Consideration" regarding  ;

misadministrations which state that the " purpose in requiring misadministration reports to NRC is to identify their causes in order to correct them and prevent their recurrence. The i Commission can do this by notifying other licensees if there is a possibility that they could  ;

make the same errors." The staff has reviewed these events on a case-by-case basis. A small number of such incidents were found not to be misadministrations. A table  !

describing each misadministration is provided in Attachment 5. I The staff examined the relationship between routine inspection findings, and reactive j inspection findings associated with misadministrations. For those licensees who had a '

misadministration at some time since the rule became effective, only 29 percent had an  ;

inspection finding related to QMP implementation during their routine inspection. However, in 56 cases (45 percent of 138 misadministrations), the staff took enforcement actions related to some aspect of the OMP during the follow-up relating to the misadministration.

Therefore, routine inspection findings are not necessarily predictors of the probability of the i occurrence of a misedministration, and there is a better, although not a strong, correlation  !

between the occurrence of a misadministration and an inspection finding related to the OM  ;

program at the time of the event. j Based on the data collected, there were at least 125 recordable events identified for the  !

883 licensees for the two years the Tl was in effect. Since licensees were not required to  !

report to NRC, nor to extensively document these events, the actual number of such events was not requested. Therefore, the actual number of recordable events is not l known. l 10 t

l i I i

ENFORCEMENT  !

4 j From March to November 1993, an NRC Quality Management Committee met weekly to '

i review all potential violations associated with the OM Rule, including those resulting from misadministrations. The committee consisted of representatives from the Office of a

Enforcement (OE), Nuclear Material Safety and Safeguards, the affected region, and the i

NRC Medical Visiting Fellow. The Committee review was intended to ensure uniformity in j the issuance of all Notices of Violation and assignment of severity levels. This review was i j truncated since guidelines for consistent imposition of enforcement sanctions seemed to be I j functioning properly and the various NRC regions were imposing a uniform enforcement

approach to violations of the OM rule.

1 l Since the effective date of the OM Rule, OE has taken enforcement actions for 56 i

misadministrations, resulting in 3 Severity Level I violations, 4 severity Level ll violations, l 36 Severity Level ill violations, and 7 Severity Level IV violations. The 6 remaining j enforcement actions had not been assigned a Severity Level. A table, identifying the misadministrations, by modality, that resulted in enforcement actions, and identifying +.he

, Severity Levels, is provided on page 64. In addition, details of these misadministrations j are included in Attachment 5.

l

SUMMARY

/ CONCLUSION

! In summary, comparison of the implementation of the OMP as reviewed during inspection, l with the written OMP (as reviewed by Lawrence Livermore National Laboratory) reveals

that overall, the implemented programs met the OM Rule objectives more often than the written programs. However, review of inspections findings for licensees' OMPs indicates -

that a total of 43 percent of the OMPs failed to meet all of the objectives of the rule.

4 i

! There has not been a significant reduction in the total number of reported i l misadministrations, the performance indicator most closely linked to this issue. While the j number of reports of diagnostic misadministrations has been significantly reduced due to l changes in the requirements of what must be reported, the net number of reported therapy

misadministrations remains at approximately 30 to 40 per year. However, the distribution of errors that led to misadministrations, per modality, has changed. For example,

! strontium-90 eye applicator events have increased significantly. An ongoing investigation i involving eye applicators is expected to add at least two more misadministrations, each c involving multiple patients, to the database.

The staff examined the relationship between routine inspection findings and reactive inspection findings associated viith misadministrations. For those licensees who had a i missdministration at some time since the rule became effective, only 29 percent had an inspection finding related to QMP implementation during their routine inspection. However,

, in 56 cases (45 percent of 138 misadministrations), the staff took enforcement actions j related to some aspect of the OMP during the follow-up relating to the misadministration.

i Therefore, routine inspection findings are not necessarily predictors of the probability of the i

occurrence of a misadministration, and there is a better, although not a strong, correlation

] 11 Ih l

1

. _ _ _ . . _ . . , . . _ .r.... . _ , _ . _.

______y P I i

l i

between the occurrence of a misadministration and an inspection finding of a weakness in i the OM program at the time of the event. '

i in 1991, the causes of misadministrations and/or abnormal occurrences were characterized ,

in the Statements of Consideration, published with the final rule, as: insufficient  ;

supervision, deficient procedures or failure to follow procedures, inattention to detail, and  ;

inadequate training. Since the OM Rule became effective, these same causes of events c appear to persist. However, most of the current errors that led to misadministrations can (

be attributed to two of the causes: inattention to detail and failure to follow procedures, both of which may be viewed as " human errors" as contrasted to " mechanical errors." i The most frequent causes of the misadministrations reported to NRC since January 27, l 1992, were as follows: ,

26 involved incorrect data entry and calculation errors, 23 involved wrong source, radiopharmaceutical, or dose (quantity), i 18 involved the wrong treatment site, 10 involved source migration /dislodgement, ,

6 involved failure to administer the entire dose or dosage (the source or dosage (capsule) was left in the pig or tandem).

l Many of the above errors that led to misadministrations could have been prevented by: (1) i redundantly checking the data entry and calculations (OM Objective 3), or (2) immediately l before administering the dose or dosage, comparing that which was to be administered to l the written directive (OM Objective 4). Thus, with the exception of equipment failures and j certain source migration /dislodgement events, it would appear that more complete j adherence to meeting the objectives in the OM Rule should reduce the likelihood of a j misadministration. I i

Although the OM Rule, which was intended to ensure that byproduct material or radiation j from byproduct material would be administered as directed by a physician authorized user, j appears to have been generally successful from a programmatic standpoint, the staff has  ;

identified certain areas of concern. Specifically, significant percentages of licensees did  ;

not implement all aspects of the rule (refer to page 63). Particularly noteworthy were the j findings associated with the requirement to conduct an adequate review of the OMP at 12-  :

month intervals.  !

in addition, there were at least 125 recordable events identified for the 883 licensees '

during the two years the Tl was in effect. Twelve percent (11) of the 92 recordable events self-identified by licensees were not evaluated, nor were appropriate corrective  ;

actions implemented. Since approximately 25 percent of the inspected licensees did not j perform adequate reviews of their administrations within each 12 month period, and therefore, may not have identified such recordable events, the actual number may be much I greater.

]

I 12

b '

- 1 e

4. * .

i 1

s. l

'I l

) '

l

.1 l

l i

j REVIEW FINDINGS l ll The .following 48 pages contain a synopsis of the QM inspection findings. It is divided into modalities of use, and each , modality compares the inspection findings to the LLNL review of the written OMP for those licensees.

1 i

0 a

13

GREATER THAN 30 MICROCURIES Nai 1-125 or 1-131 Inspection of implemented QMPs:

Seven hundred and thirty sets of sodium iodide 1-125 or 1-131 Tl field notes were entered into the database. Sixty-four of these had been inspected (and entered) twice.

Therefore, the total number of QM inspections included is 666.

Review of Written OMPs:

During the contracted review of the initially submitted written QMPs, LLNL reviewed 1568 sodium iodide 1-125 or 1-131 QMPs. However, only 491 of the 666 Implemented QMPs inspected had been previously reviewed by LLNL.

Written Directives:

The total number of written directives for these 666 licensees, over a 2-year period, was 39,819. For sodium lodide 1-125 or 1-131, there will usua#y be one written directive per administration.

OMP Review Fendinas:

The following is a review of the findings of the inspection of the implemented QMPs

< (QM TI), compared to the LLNL findings of the review of the written QMPs. The LLNL data provided in each response, matches the specific QMP findings provided by the Ti (same population).

Obiective 1:

Criteria:

As described in 10 CFR 35.2, a written directive for administration of greater than 30 microcuries of sodium iodide I-125 or I-131 must include the dosage.

TI Review Fandinas:

On inspection, 37 of 666 licensees failed to meet Obiective 1 in that:

37 licensees did not consistently prepare written directives.

15 licenses & did not include all necessary information on the written directive.

F 14

i i

LLNL Review Findings-  !

l When compared to the LLNL review of the initially submitted written QMPs:

9 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

10 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

18 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

I OBJECTIVE 2:

Criteria:

l The licensee must implement procedures to ensure that, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive.

Tl Review Fuu5nas:

i 7 licensees failed to meet Objective 2 in that, they did not implement procedures to redundantly identify patients and/or human research subjects.

LLNL Findinas:

1 licensee had written procedures that met Objective 2, as reviewed by LLNL, but i l

apparently did not implement them. l 1 licensee, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

5 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

l OBJECTIVE 3:

Cetteria:

The licensee must implement procedures to ensure that final plans of treatment and i relt. sed calculations are in accordance with the respective written directive.

1 f

15

Obbctive 4:

Criteria:

The licensee must implement procedures to verify, prior to administration, that the specific details are in accordance with written directive.

TI Review Findnqss:

On inspection, 46 of 666 licensees who administered areater than 30 microcuries of sodium iodide I-125 or 1-131, failed to meet Obiective 4.

LLNL Review Findngs:

When compared to the LLNL review of the initially submitted written QMPs,  !

7 licensees had written procedures, as reviewed by LLNL, but apparently did not ,

implement them. l 1

25 licensees, who did not meet the objective upon inspection, did not meet the  :

objective in their written QMP.  !

14 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee may have implemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Dosaae Measured Prior to Administration:  ;

r Tl Review Findinas:

12 licensees did not implemr.it a procedure to assess the quantity of byproduct material in the prepared Gsage prior to administration. I LLNL Review Findinas:

5 licensees, who did not meet the objective upon inspection, did not meet the objective in their written CMP.

7 licensee's initially submitted QMPs were apparently not reviewed I,y LLNL.

2. Dosaae Confirmed Just Prior to Administration:

1 Tl Review Findinas:

35 licensees did not implement procedures to confirm that the dosage matched the applicable written directive prior to administration.

16 l

I l

_ . _ _ . _ . _ _ _- _ _ _ _ _ _ _ . _ . . _ . _ . ~ . _ . _ _

i .

OBJECTIVE 5: i t

Criteria: '

The licensee must implement procedures to ensure that any unintended devietion from  !

the written directive is identified and evaluated, and appropriate action is taken.

On inspection,109 of 666 licensees who administered areater than 30 microcuries of  ;

sodium lodide 1-125 or I-131. failed to meet Obiective 5.

{

l LLNL Review Fim5nos: ,

l When compared to the LLNL review of the initially submitted written QMPs, 18 licensees had written procedures, as reviewed by LLNL, but apparently did not i implement them.

i 59 licensees, who did not meet the objective upon inspection, did not meet the objective in their written QMP.

34 licensee's initially submitted OMPs were apparently not reviewed by LLNL.

Procedures that the licensee must have implemented include, but were not Emited to:

l i 1. Maintain Record of Administration: I i

13 licensees did not implement procedures to maintain records of administration in an auditable form.

l LLNL Review Findinos:

2 licensees had written procedures, as reviewed by LLNL, but apparently did not  !

implement them. I 4 licensees, who did not meet the objective upon inspection, did not meet the objective in their written QMP.

7 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

2. Procedures implemented to identify " Unintended Deviations":

25 licensees did not implement procedures to identify unintended deviations from the written directive.

l l

l 17

~ - _ . . . . - , - _ - . - - . - . . - . - _ - . - - . - - - - _ - - - . - - - - . .

1

3. Procedures to Evaluate and Respond to Recordable Events and Mised...ir.iehetier.s Within 30 Davs of Discoverv:

TI Review Findings: .

96 licensees did not implement procedures to evaluate and respond to recordable events and misadministrations.  !

LLNL Review Findinas: ,

21 licensees had written procedures, as reviewed by LLNL, but apparently did ,

not implernent them, i 45 licensees did not meet the objective for their written or implemented OMP.  !

30 licensee's initially submitted QMPs were apparently not reviewed by LLNL. 3 l

Procedures implemented to nether the relevant facts and to identify and  !

imDiement Corrective action to prevent reCurrenCS:

Tl Review Findinas:

39 licensees did not implement procedures to gather the relevant facts regarding ,

recordable events and/or misadministrations, and to identify and implement  ;

corrective action to prevent recurrence. [

l Periodc Review of the QMP:  ;

Oriteds:

The licensee shall develop procedures for and conduct a review of the OMP, including: I a representative sample of all administrations; all recordable events; and all misadministrations. These reviews shall be conducted at intervals of no greater than 12 months.

Tl Review Findings:

166 licensees (20%) did not implement procedures that met the requirement.

Expand the Review if Events Are identified:

166 licensees did not implement procedures to expanded the review if recordable events or misadministrations were identified.

Determine Effectiveness:

134 licensees did not evaluate their QMP after each review to determine the l effectiveness of the program.

l l 18 i

l l l i

l l Recordable Events:

l 46 recordable events were self-identified by the license since the last inspection.

l 16 previously unidentified recordable events were identified by the inspector I during the inspection of the licensee's implemented QMP.

! Misadministrations:

8 misadministrations were reported to NRC by the license since the last inspection.

l 1 licensee identified a misadministration that was not subsequently reported to NRC.

l l LLNL Review Findinas:

1 72 licensees had written procedures to perform a review of the QMP, as reviewed by l LLNL, but apparently did not implement them.

45 licensee's QMP did not include procedures to review the QMP. )

l 49 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

l 1 l

l \

r 19 I

i l

- .. ___ . - .. -. . _ .= -_ . .

l 1

RADIOPHARMACEUTICAL THERAPY inspection of Imolemented QMP Five hundred and forty-eight' sets of radiopharmaceutical therapy Tl field notes were i entered into the database. Sixty-one of these had been inspected (and entered) twice. l Therefore, the total number of QM inspections included is 487 (548-61). l Review of Written QMP:

During the contracted review of the initially submitted written QMPs, LLNL reviewed 1019 radiopharmaceutical therapy QMPs. However, only 418 of the 487 Implemented QMPs inspected, had been previously reviewed by LLNL.

Written Directives:

The total number of written directives for these 487 licensees, over a 2-year period, was 4,992. For radiopharmaceutical therapy, there will usua#y be one written directive per administration.

QMP Review Findinas:

The following is a review of the findings of the inspection of the implemented QMPs  ;

(QM TI), compared to the LLNL findings of the review of the written QMPs. The LLNL data provided in each response, matches the specific QMP findings provided by the Tl 4 (same population).

l l

i Ohioctive_1:

Criteria: I As described in 10 CFR 35.2, a written directive for radiopharmaceutical therapy must include: the radiopharmaceutical, the dosage, and the route of administration.

T1 Review Findings:

On inspection, 48 of 487 licensees failed to meet Obiective 1 in that:

40 licensees did not consistently prepare written directives.

48 licensees did not include all necessary information on the written directive.

20

I l LLNL Review Findinos:

When compared to the LLNL review of the initially submitted written QMPs:

8 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

l 28 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

12 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

OBJECTIVE 2:

l Criteria:

The licensee must implement procedures to ensure that, prior to each administration, l the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive.

l l Tl Review Findinos:

32 licensees failed to meet Objective 2 in that, they did not implement procedures to l redundantly identify patients and/or human research subjects.

LLNL Findinas:

l 19 licensee had written procedures that met Objective 2, as reviewed by LLNL, but i apparently did not implement them.

4 licensees, who did not meet the objective upon inspectios., did not meet the objective in the written QMP.

9 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

l OBJECTIVE 3:

l l Criteria:

l l

The licensee must implement procedures to ensure that final plans of treatment and related calculations are in accordance with the respective written directive.

1 21

9hioctive 4:

Criteria:

The licensee must implement procedures to verify, prior to administration, that the specific details are in accordance with written directive.

TI Review Findmas:

On inspection, 53 of 487 radiopharmaceutical theraov licensees, failed to meet Obiective 4.

LLNL Review F*mdinos:

When compared to the LLNL review of the initially submitted written QMPs:

23 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

15 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

15 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee may have implemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Dosaae Measured Prior to Administration:

Tl Review Findinos:

59 licensees did not implement a procedure to assess the quantity of byproduct materialin the prepared dosage prior to administration.

LLNL Review Findinos:

24 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

24 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

11 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

22

. .. . _ , _ _ _ .= . .- . - - _ . . . . - . - - .

2. Dosaae Confirmed Just Prior to Administration:

Tl Review Findinas:

l 49 licensees did not implement procedures to confirm that the dosage matched l the applicable written directive prior to administration.

l j OBJECTIVE 5:

Criteria:

l l The licensee must implement procedures to ensure that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

On inspection,100 of 487 radiooharmaceutical theraov licensees failed to meet Obiective 5.

LLNL Review Findinas:

l When compared to the LLNL review of the initially submitted written QMPs, 74 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

9 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP. '

l 17 licensee's initially submitted QMPs were apparently not reviewed by LLNL.  ;

i Procedures that the licensee must have *wnplemented include, but were not limited to: l l

1. Maintain Record of Administration: i 34 licensees did not implement procedures to maintain records of administration I in an auditable form.

l LLNL Review F!ndinas:

25 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

l 9 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

l

?

23

2. Procedures Implemented to identify " Unintended Deviations":

38 licensees did not implement procedures to identify unintended deviations I from the written directive.

I

3. Procedures to Evaluate and Respond to Recordable Events and I Misadministrations Within 30 Days of Discovery:

Tl Review Findinas-89 licensees did not implement procedures to evaluate and respond to I recordable events and misadministrations.

l LLNL Review Findinos:  ;

61 licensees had written procedures, as reviewed by LLNL, but apparently did i not implement them.

13 licensees did not meet the objective for their written or implemented QMP.

15 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures implemented to gather the relevant facts and to identify and implement corrective action to prevent recurrence:

Tl Review Findinas:

57 licensees did not implement procedures to gather the relevant facts regarding recordable events and/or misadministrations, and to identify and implement corrective action to prevent recurrence.

Periodic Review of the QMP:

Criteria: l l

The licensee shall develop procedures for and conduct a review of the QMP, including: l a representative sample of all administrations; all recordable events; and all l misadministrations. These reviews shall be conducted at intervals of no greater than l 12 months.

TI Review Findinos 155 licensees did not implement procedures that met the requirement:

Expand the Review if Events Are identified:

155 ticensees did not implement procedures to expanded the review if recordable events or misadministrations were identified.

24 l

a 0

l Determine effectiveness: )

25 licensees did not evaluate their QMP after each review to determine the l

) effectiveness of the program.

)

i Recordable Events:

22 recordable events were self-identified by the license since the last

inspection.

8 previously unidentified recordable events were identified by the inspector i during the inspection of the licensee's implemented QMP.

Misadministrations:

1 misadministration was reported to NRC by the license since the last inspection.

3 licensees identified misadministrations that were not subsequently reported to NRC.

LLNL Review Findinos:

55 licensees had written procedures to perform a review of the QMP, as reviewed by LLNL, but apparently did not implement them.

76 licensee's QMPs did not include procedures to review the QMP.  !

24 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

l 1

25

__ .. .. - .._ _ _ _ - _ _ _ _ _ . _ . _ _ - _ . - . _ _ . . ~ . _ __ _ . _ . _ _ . -.

t

?

HIGH DOSE RATE (HDR) BRACHYTHERAPY i Inspection of implemented QMP:

One hundred and fifty-six sets of HDR Tl field notes were entered into the database. ,

Forty-six of these had been inspected (and entered) twice. Therefore, the total number j of QM inspections included is 109 (156-47).

Review of Written QMP: i During the contracted review of the initially submitted written QMPs, LLNL reviewed ,

101 HDR QMPs. However, only 82 of the 109 implemented QMPs inspected, had [

be'en previously reviewed by LLNL. i Written Directives:

The total number of written directives for these 109 licensees, over a 2-year period, I was 10,000. For HDR, there may be one written directive, ordering a dose in multiple ,

fractions. Therefore, it is not possible to ascertain the number of administrations.

QRP Review Findinas:

The following is a review of the findings of the inspection of the implemented QMPs (QM TI), compared to the LLNL findings of the review of the written OMPs. The LLNL data provided in each response, matches the specific QMP findings provided by the Tl '

(same population). l l

Obiective 1: l l

Criteria: l l

1 As described in 10 CFR 35.2, a written directive for HDR must include:

the radioisotope, the treatment site, and the total dose.

Tl Review Findinas:

On inspection, 7 of 109 HDR licensees failed to meet Obiective 1 in that:

3 licensees did not consistently prepare written directives.

6 licensees did not include all necersary information on the written directive.

26 i

LLNL Review Findingt; .

l When compared to the LLNL review of the initially submitted written QMPs:

2 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

4 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

1 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

OBJECTNE 2: l l

Criteria: ]

i The licensee must implement procedures to ensure that, prior to each administration, j the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive. ,

Tl Review Findngs:

2 brachytherapy licensees failed to meet Objective 2 in that, they did not implement procedures to redundantly identify patients and/or human research subjects.  ;

LLNL Findings:

1 licensee, who did not meet the objective upon inspection, did nnt meet the objective in the written QMP. ,

1 licensee's QMP had not been initially reviewed by LLNL. ,

1 OBJECTNE 3:

Criteria:  !

The licensee must implement procedures to ensure that final plans of treatment and related calculations are in accordance with the respective written directive. Since l acceptance testing of new and/or repaired equipment is not specifically required, l licensees who did not have procedures for acceptance testing, but implemented other applicable procedures, met the objective. (

1 27

TI Review Findinas:

On inspection, 3 of 109 HDR licensees failed to meet Obiective 3.

LLNL Review Findinas:

When compared to the LLNL review of the initially submitted written QMPs, 1 licensee, who did not meet the objective upon inspection, did not meet the objective in the written OMP.

2 licensee's initially submitted QMP was apparently not reviewed by LLNL. l Procedures that the licensee may have implemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Check of Calculations:

1 Perform a check of the treatment calculations (whenever possible by another qualified individual) before beginning treatment.

I Tl Review Findinas:

2 licensees did not implement procedures to check calculations before beginning )

treatment. l l

LLNL Review Findinos:

J 2 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

2. Acceptance Testina:

Perform an acceptance test on new or repaired equipment.

1 Tl Review Findinas:

9 licensees do not implement procedures to acceptance test new or repaired equipment.

LLNL Review Findinas:

7 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them. .

2 licensees, who did not meet the objective upon inspection, did not meet the ,

objective in the written QMP. I 28

l

~

i Obiective 4:

Criteria:

The licensee must implement procedures to verify, prior to administration, that the j specific details are in accordance with written directive.

Tl Review Findngs:

On inspection, 7 of 109 HDR licensees failed to meet Obiective 4.

LLNL Review Findings:

When compared to the LLNL review of the initially submitted written OMPs:

5 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

2 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee may have implemented (several are requirements '

l elsewhere in Part 35) m

• clude, but were not limited to:

1. Treatment Plan:

A plan of treatment is prepared in acc ardance with the written directive.

TLRgview Findinas:

2 licensees did not implement procedure to prepare a treatment plan that was in accordance with the written directive.

LLNL Review Findinas:

1 licensee, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

1 licensee's initially submitted QMP was apparently not reviewed by LLNL.

2. Confirm Parameters of Administration:

Tl Review Findinas:

3 licensees did not implement procedures to confirm the prescribed radioisotope, treatment site, and total dose before administration.

l 29

.._ _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _ _ _ _ . _ . ___.____._._-_._-m ._

LLNL Review Findinas:

2 licensees had written' procedures, as reviewed by LLNL, but apparently did not implement them. l 3 '

L 1 licensee's initially submitted QMP was apparently not reviewed by LLNL.

3. Dwell Times and Positions Verified:

i 3 licensees did not implement procedures to verify dwell times and positions l- prior to the start of the treatment.

i i 4. Use of Dummy Sources or Fixed Geometry Adcetors:

l 3 licensees did not implement procedures to verify the source positioning, within the treatment site, using dummy sources or fixed geometry applicators before 4

! inserting the radioactive sealed sources.

l I 5. Prompt Recordina of Treatment Parameters:  !

. a 5 licensees did not implement procedures for the prompt recording of the

' treatment parameters, and signing or initialing by the authorized user, in the patient's chart or record.

} LLNL Review Findinas:

l 4 licensees, who did not meet the objective upon inspection, did not meet the

objective in the written QMP.

1 licensee's initially submitted QMP was apparently not reviewed by LLNL. I 4

QBJECTIVE 5:

! Critada:

l The licensee must implement procedures to ensure that any unintended deviation from i

the written directive in identified and evaluated, and appropriate action is taken.

}

T1 Review Findinas:

{ On inspection, 22 of 109 HDR licensees failed to meet Obiective 5:

1 i

! 30 l

Y

i i e LLNL Review Findinos:

When compared to the LLNL review of the initially submitted written QMPs, l

l 9 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

6 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

7 licensee's initially submitted OMPs were apparently not reviewed by LLNL.

Procedures that the licensee must have implemented include, but were not limited to:

1. Maintain Record of Administration:

2 licensees did not implement procedures to maintain records of adminirtration in an auditable form.

2. Procedures implemented to identify " Unintended Deviations":

4 licensees did not implement procedures to identify unintended deviations from the written directive.

3. Procedures to Evaluate and Respond to Recordable events and Misadministrations Within 30 Days of Discovery:

TI Review Findinas:

22 licensees did not implement procedures to evaluate and respond to recordable events and misadministrations.

LLNL Review Findinas:

9 licensee had written procedures, ss reviewed by LLNL, but apparently did not implement them.

l 6 licensees did not meet the objective for their written or implemented QMP. 1 7 licensees

• initially submitted QMPs were apparently not reviewed by LLNL.

i i

l 31

4. Procedures implemented to Gather the Relevant Facts and To identify and implement Corrective Action to Prevent Recurrence:

Tl Review Findinas:

8 licensees did not implement procedures to gather the relevant facts regarding recordable events and/or misadministrations, and to identify and implement corrective action to prevent recurrence.

Periodic Review of the QMP:

Criteria:

The licensee shall develop procedures for and conduct a review of the QMP, including:

a representative sample of all administrations; all recordable events; and all misadministrations. These reviews shall be conducted at intervals of no greater than 12 months.

TI Review Fendinos:

25 licensees did not implement procedures that met the requirement:

Expand the Review if Events Are identified:

25 licensees did not implement procedures to expanded the review if recordable events or misadministrations were identified.

Determine Effectiveness:

7 licensees did not evaluate their QMP after each review to determine the effectiveness of the program.

Recordable Events:

7 recordable events were self-identified by the license since the last inspection.

2 previously unidentified recordable events were identified by the inspector during the inspection of the licensee's implemented QMP.

Misadministrations:

1 misadministration was reported to NRC by the license since the last inspection.

32 i

l l

i LLNL Review Findmas: l l

1 10 licensees had written procedures to perform a review of the QMP, as reviewed by LLNL, but apparently did not implement them.

8 licensee's QMP did not include procedures to review the QMP.

7 licensee's initially submitted OMPs were apparently not reviewed by LLNL.

l 33

4 BRACHYTHERAPY Inspection of lmolemented QMP:

Three hundred and eleven sets of brachytherapy Tl field notes were entered into the database. Forty-five of these had been inspected (and entered) twice. Therefore, the total number of QM inspections included is 266 (311-45).

Review of Written QMP:

During the contracted review of the initially submitted written QMPs, LLNL reviewed 520 brachytherapy QMPs. However, only 230 of the 266 implemented QMPs inspected, had been previously reviewed by LLNL.

Written Directives:

The total number of written directives for these 266 licensees, over a 2-year period, was 8,499.

QMP Review Findinas:

The following is a review of the findings of the inspection of the implemented OMPs (QM TI), compared to the LLNL findings of the review of the written QMPs. The LLNL data provided in each response, matches the specific QMP findings provided by the Ti (same population).

Obiective 1:

Criteria:

As described in 10 CFR 35.2, a written directive for brachytherapy must include:

(i) Prior to implantation: the radioisotope, nurnber of sources, and source strengths; and (ii) Af ter implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or equivalently, the total dose).

Tl Review Findinas:

On inspection,11 of 266 brachytheraov licensees failed to meet Obiective 1 in that:

2 licensees did not consistently prepare written directives.

l j 9 licensees did not include all necessary information on the written directive.

l 34 i

i l

l - _ _ _ _ _. - - _ . - _ - -

. 1 1

LLNL Review Findinos:

When compared to the LLNL review of the initially submitted written QMPs: l 5 licensees had written procedures, as reviewed by LLNL, but apparently did not l implement them. I 4 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP. ,

1 licensee's initially submitted QMP was apparently not reviewed by LLNL.

l OBJECTIVE 2: ,

Criteria: l The licensee must implement procedures to ensure that, prior to each administration, the patient's e human research subject's identity is verified by more than one method  ;

cs the individual named in the written directive.

Tl Review Findugs:

1 brachytherapy licensee failed to meet Objective 2 in that, they did not implement j precedures to redundantly identify patients and/or human research subjects.  !

i LLNL Findinas:

The licensee, who did not meet the objective upon inspection, did not meet the i objective in the written QMP.

1 I

OBJECTIVE 3:

Criteria:

The licensee must implement procedures to ensure that final plans of treatment and

, ralated calculations are in accordance with the respective written directive. Since ccceptance testing of new and/or repaired equipment is not specifically required, licensees who did not have procedures for acceptance testing, but implemented other Epplicable procedures, met the objective.

l i

35

)

l l

Tl Review Findinos:

On inspection,14 of 266 brachytheraov licensees fai!ps to meet Obiective 3.

LLNL Review Findinas:

When compared to the LLNL review of the initially submitted written QMPs, 3 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

7 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

l 4 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee may have implemented (several are requirements i elsewhere in Part 35) include, but were not limited to:

l 1. Preparation of Treatment Plans:

A plan of treatmentis prepared in accordance with the written directive.

l Tl Review Findinos:

4 licensees did not implement a procedure to assure that a treatment plan was prepared.

LLNL Review Findinos:

2 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them. ,

2 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

2. Check of Calculations: l Perform a check of the treatment calculations (whenever possible by another qualified individual) before beginning treatment.

Tl Review Findinos:

11 licensees did not implement procedures to check calculations.

36

4 i '

1 LLNL Review Findinos:

I 7 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

4 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

2. Acceptance Testina:

Perform an acceptance test on new or repaired equipment.

, Tl Review Findinas:

i 17 licensees do not implement procedures to acceptance test new or repaired j equipment.

. LLNL Review Findinos:

! 9 licensees had written procedures, as reviewed by LLNL, but apparently did not

implement them.

3 4 licensees, who did not meet the objective upon inspection, did not meet the i

objective in the written QMP.

i 4 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Obiective 4:

Criteria:

The licensee must implement procedures to verify, prior to administration, that the specific details are in accordance with written directive.

Tl Review Findinos:

On inspection,13 of 266 brachytheraov licensees failed to meet Obiective 4.

LLNL Review Findenos:

When compared to the LLNL review of the initially submitted written QMPs:

5 licensees had written procedures, as reviewed by LLNL, but apparently did not .

implement them.

5 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

3 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

37

Procedures that the Econoce may have implemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Confirmation of Treatment Plans:

Licensees implements a procedure that required the person administering ,

treatment to confirm the prescribed radioisotope, the number of sources, the ,

source strengths, the treatment site, the loading sequence, and total dose. '

Tl Review Findinas:

1 licensee did not implement procedures to confirm treatment plans.

LLNL Review Findinas:

The licensee had written procedures, as reviewed by LLNL, but apparently did l' not implement them.

t

2. Confirm Administration Parameters: i Licensees implements procedures that required prompt recording of the number of sources, the actual loading sequence of sources implanted (location of each  ;

sealed source in a tube, tandem, or cylinder), and signing or initialing the patient's chart or appropriate record.

Tl Review Findinas:

13 licensees did not implement these procedures to confirm administration 5 parameters. ,

3. Prompt Recordina of Yreetnient Parameters:  !

l Tl Review Findinas:

7 licensees did not implement procedures for the prompt recording of the treatment parameters, and signing or initialing in the patient's chart or record. ,

l LLNJ. Review Findinas: l l

2 licensees had written procedures, as reviewed by LLNL, but apparently did not l implement them.

2 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

3 licensee's initially submitted OMPs were apparently not reviewed by LLNL.

38 l i

i j

~

OBJECTIVE 5:

Criteria:

The licensee must implement procedures to ensure that any unintended deviation from j the written directive is identified and evaluated, and appropriate action is taken.

! On inspection, 35 of 266 brachythernov licensees failed to meet Obiective 5:

LLNL Review Fendinas:

When compared to the LLNL review of the initially submitted written QMPs, 10 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

22 licensees, who did not meet the objective upon inspection, did not meet the objective in '.he written QMP.

3 licensee's initially submi'.ted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee must have implemented include, but were not limited to:

1. Maintain Record of Administration: j 2 licensees did not implement procedures to maintain records of administration l in an auditable form.

Procedures implemented to identify " Unintended Deviations":

2 licensees did not implement procedures to identify unintended deviations from the written directive.

2. Procedures to Evaluate and Respond to Recordable Events and Misadministrations Within 30 Days of Discoverv:

Tl Review Findinas:

31 licensees did not implement procedure:: to evaluate and respond to recordable events and misadministrations.

LLNL Review Findinos:

10 licensee had written procedures, but apparently did not implement them.

19 licensees did not meet the objective for their written or implemented QMP.

l 2 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

39 l l l I l l l

i I

3. Procedures implemented to Gather the Relevant Facts and to identify and implement Corrective Action to Prevent Recurrence: i Tl Review Findinas: l 15 licensees did not implement procedures to gather the relevant facts regarding recordable events and/or misadministrations, and to identify and implement l corrective action to prevent recurrence. - '

Periodic Review of the QMP:

Criteria: 1 1

The licensee shall develop procedures for and conduct a review of the QMP, including: .l a representative sample of all administrations; all recordable events; and all  ;

misadministrations. These reviews shall be conducted at intervals of no greater than <

12 months.

TI Review Findinas:

i l

65 licensees did not implement procedures that met the requirement: l l

Expand the Review if Events Are identified:

)

65 licensees did not implement procedures to expanded the review if recordath  !

events or misadministrations were identified.

Determine Effectiveness:

7 licensees did not evaluate their QMP after each review to determine the E effectiveness of the program. I Recordable Events:

13 recordable events were self-identified by the license since the last inspection.

3 previously unidentified recordable events were identified by the inspector during the inspection of the licensee's implemented QMP.

Misadministrations:

2 misadministrations were reported to NRC by the lic6nse since the last '

inspection.

2 licensees identified misadministrations that were not subsequently reported to NRC. ,

i

,40

1 LLNL Review Fmdinos:

I 33 licensees had written procedures to perform a review of the QMP, but apparently did not implement them.

26 lic nsae's QMP did not include procedures to review the QMP.

6 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

- D I

1

. l 1 i

, l ll 4

1 i

i 4 i

!l i l

s j 41 i

e

.- , . - - . _ - . ~ . . - . - . _

STRONTIUM-90 EYE APPLICATOR Inonection of Imolomonted QMP: l l

Seventy-two sets of Strontium-90 eye applicator Tl field notes were entered into the database. Nine facilities had been inspected (and entered) twice. Therefore, the total  ;

number of OM inspections included is 63. 1 Review of Written QMP: I At the time the QM Rule was promulgated, Strontium-90 eye applicators were not  !

identified as a separate modality from brachytherapy. No specific guidance was 1 provided to licensees in Regulatory Guide 8.33, " Quality Management Programs," nor i was a standard review plan for review of Strontium-90 eye applicators developed.

Therefore, this modality was not reviewed by LLNL. l Written Directives:

The total number of written directives for these 63 licensees, over a 2-year period, was 2,341.

i QMP Review Fim5nes:

The following is a review of the findings of the inspection of the implemented QMPs

( Q M TI).

Obiective..1:

Cdteria:

A written diirective for Strontium-90 eye applicator administrations should include: the treatment site, the source strength and exposure time, or total dose. The contents of a written directive for Strontium-90 eye applicators is not described in 10 CFR 35.2.

Tl Review.Fim5ngs:

On inspection,10 of 63 Strontium-90 eve anolicator licensees failed to meet .

Obiective 1 in that:  !

9 licensees did not consistently prepare written directives.

10 licensees did not include t! necessary information on the written directive.

l 42 l l

I.

j OBJECTIVE 2:

Criteria:

, The licensee must implement procedures to ensure that, prior to each administration, l the patient's or human research subject's identity is verified by more than one method I

as the individual named in the written directive.

i l Tl Review Findinas:

j All inspected Strontium-90 eye applicator licensee met Objective 2.

i

! OBJECTIVE 3:

. Criteria:

l The licensee must implement procedures to ensure that final plans of treatment and l related calculations are in accordance with the respective written directive. Since

! acceptance testing of new and/or repaired equipment is not specifically required, licensees who did not have procedures for acceptance testing, but implemented other applicable procedures, met the objective.

I Tl Review Findings:

i On inspection, 9 of 63 Strontium-90 eve anolicator licensees failed to meet l Obiective 3.

l Procedures that the licensee may have irnplemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Etaparation of Treatment Plans:

A plan of treatmentis prepared in accordance with the written directive.

i Tl Review Findinas:

4 licensees did not implement a procedure to assure that a treatment plan was prepared.

I 2. Check of Calculations:

Perform a check of the treatment calculations (whenever possible by another j qualified individual) before beginning treatment. At a mintmum, assess the 3 quantity of material rernaining after decay (decay chart or other method)

L T

Tl Review Findinos:

7 licensees did not implement procedures to check calculations.

I 43 l

4 b

1 i.

Objective 4:

Criteria:

The licensee must implement procedures to verify, prior to administration, that the specific details are in accordance with written direct've.

TI Review Findinas:  ;

On inspection,11 of 63 Strontium-90 eve anolicator licensees failed to meet Obiective 4.

t Procedures that the licensee rnay have implemented (several are requirements ,

elsewhere in Part 35) include, but were not Emited to.  !

i

1. Confirmation of Treatment Plans:

Person administering treatment confirms the written directive including, the total

• dose, the prescribed treatment site, the source strength, and the method used to time the administration.

Tl Review Findinas:  !

11 licensee did not implement procedures to confirm treatment plans.

OBJECTIVE 5:

Criteria:

The licensee must implement procedures to ensure that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

On inspection,14 of 63 Strontium-90 eve applicator licensees failed to meet ,

Obiective 5: )

Procedures that the licensee must have implemented include, but were not limited to:

1. Maintain Record of Administration: l 2 licensees did not implement procedures to maintain records of administration ,

in an auditable form. i Procedures implemented to identify " Unintended Deviations": 4 l

6 licensees did not implement procedures to identify unintended deviations from 7.he written directive.

44

2. Procedures to Evaluate and Respond to Recordable Events and Misadministrations Within 30 Days of Discovery:

Tl Review Findinas:

14 licensees did not implement procedures to evaluate and respond to recordable events and misadministrations.

3. Procedures implemented to Gather the Relevant Facts and To identify and implement Corrective Action to Prevent Recurrence:

Tl Review Findinas:

8 licensees did not implement procedures to gather the relevant facts regarding recordable events and/or misadministrations, and to identify and implement corrective action to prevent recurrence.

Periodic Review of the QMP:

Criteria:

The licensee shall develop procedures for and conduct a review of the QMP, including:

a representative sample of all administrations; all recordable events; and all misadministrations. These reviews shall be conducted at intervals of no greater than 12 months.

Tl Review Findinas:

31 licensees did not implement procedures that met the requirement:

1. Expand the Review if Events Are Ider:tified:

31 licensees did not implement procedures to expanded the review if recordable events or misadministrations were identified.

2. Determine Effectiveness:

7 licensees did not evaluate their QMP after each review to determine the effectiveness of the program.

3. Recordable Eventt,:

1 recordable event was self-identified by the license since the last inspection.

1 previously unidentified recordable events was identified by the inspector during the inspection of the licensee's implemented OMP.

45

t Misadministrations:

No misadministrations were reported to NRC by the license since the last t inspection.  ;

l P

k I

)

1 1

46 -

TELETHERAPY inspection of implemented OMP:

Eighty-one sets of teletherapy Tl field notes were entered into the database. Eight of these had been inspected (and entered) twice. Therefore, the total number of QM inspections included is 73 (81-8).

Review of Written QMP:

During the contracted review of the initially submitted written QMPs LLNL reviewed 129 teletherapy QMPs However, only 63 of the 73 implemented QMPs inspected, had bee.n previously reviewed by LLNL.

Written Directives:

The total number of written directives for these 73 licensees, over a 2-year period, was 9,407. For teletherapy, there will usually be one written directive, ordering a dose in multiple fractions. Therefore, it is not possible to ascertain the number of administrations.

QMP Review Fendinas:

The following is a review of the findings of the inspection of the implemented QMPs (QM TI), compared to the LLNL findings of the review of the written QMPs. The LLNL data provided in each response, matches the specific QMP findings provided by the TI l (same population).

Obiective 1:

j Criteria:

As described in 10 CFR 35.2, a written directive for teletherapy must include: the total dose, the dose per fraction, treatment site, and overall treatment period.

T1 Review Findinas:

On inspection,11 of 73 Teletheraov licensees failed to meet Obiective 1 in that:

Tl Review Findinas: -

Although all licensees consistently prepared written directives, 11 licensees did not include all necessary information on the written directive.

4 47 i

I i

, i LLNL Findnes:

When compared to the LLNL review of the initially submitted written QMPs: l 9 licensees had written procedures that met Objective 1, as reviewed by LLNL, but .

apparently did not implement them.

1 licensee, who did not implement procedures to meet Objective 1, also did not i initially submit a written QMP that included procedures that met Objective 1.

1 licensee's QMP had not been initially reviewed by LLNL.

1 OBJECTIVE 2:

~

Criteria:

The licensee must implement procedures to ensure that, prior to each administration, l the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive.

Tl Review Findinas: i 2 Teletherapy licensees failed to meet Objmtive 2 in that, they did not implement procedures to redundantly identify patients and/or human research subjects.

LLNL Findinas: i 1 licensee had written procedures that met Objective 2, as reviewed by LLNL, but apparently did not implement them. '

1 licensee's QMP had not been initially reviewed by LLNL.

OBJECTWE 3:

Criteria:

The licensee must implement procedures to ensure that final plans of treatment and related calculations are in accordance with the respective written directive. Since acceptance testing of new and/or repaired equipment is not specifically required, licensees who did not have procedures for acceptance testing, but implemented other applicable procedures, met the objective.

48

1 Tl Review Findinas:

i j On inspection, 30 of 73 telethernov licensees failed to meet Objective 3.

t i

LLNL Review Findinas:

! When compared to the LLNL review of the initially submitted written QMPs, 11 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

12 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

7 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee may have implemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Check of Calculations:

Perform a check of the treatment calculations (whenever possible by another j qualified individual) before beginning treatment.

Tl Review Findinas:

3 licensees did not implement procedures to check calculations.

, LLNL Review Findinas:

2 licensees did not provide written procedures that required a check of calculations before beginning treatment.

2. Acceptance Testina:

Perform an acceptance test on new or repaired equipment.

Tl Review Findinas:

15 licensees do not implement procedures to acceptance test new or repaired equipment.

LLNL Review Findinos:

10 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them. -

5 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

49

3. Determinina Trzasmission Factors for Beam Modifyina Devices Before First Use and After Source Reolacement:

TI Review Findinas:

9 licensees do not implement such procedures.

LLNL Review Findinas:

3 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

2 licensees did not meet the objective for their written or implemented QMP.

4 licensee's initially r..nmitted QMPs were apparently not reviewed by LLNL.

4. Physical Measr;ns of the Teletheraov Outout for Treatment Parameters not Fully Addressed the Most Recent Full Calibration:

Tl Review Findinas:

22 licensees did not implement this procedure.

LLNL Review Findinas:

15 licensees had written procedures, as reviewed by LLNL, but apparently did i ne* implement them.

3 licensees did not rneet the objective for their written or implemented QMP.

4 licensee's initially submitted OMPs was apparently not reviewed by LLNL.

5. Checkina Dose Calculations for Administrations in Fractions: (this procedure should include consideration of the number of fractions and the specified time within which the check should be performed)

Tl Review Findinas:

5 licensees did not implement this procedure.

LLNL Review Findinas:

1 licensee had written procedures, as reviewed by LLNL, but apparently did not ,

implement them. l 2 licensees did not meet the objective for their written or implemented QMP.

2 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

50

Obiective 4:

Criteria: ,

1 I

The licensee must implement procedures to verify, prior to administration, that the i specific details are in accordance with written directive [35.32(a)(4)] )

Tl Review Findings:

On inspection,10 of 73 teletheraov licensees failed to meet Obiective 4.

LLNL Review Findinos:

When compared to the LLNL review of the initially submitted writtcn QMPs, 3 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

3 licensees, who did not meet the objective upon inspection, did not meet the objective in the written OMP.

4 licensee's initially submitted QMPs were apparently not reviewed by LLNL.'

i Procedures that the licensee may have implemented (several are requirements  ;

elsewhere in Part 35) include, but were not limited to: l

1. Treatment Plan:

A plan of treatment is prepared in accordance with the written directive Tl Review Findinas:

7 licensees did not implement a procedure to assure that a treatment plan was prepared.

2. Confirmation of Treatment Plans:

Person administering treatment confirms the written directive and plan of treatment. At a minimum, the verification of treatment site and dose per fraction.

Tl Review Findinas:

8 licensees did not implement these procedures.

v i

4 l 51

LLNL Review Findinas:

3 licensees did not meet the objective for their written or implemented QMP.

10 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

4 licensees did not meet the objective for their written or implemented QMP.

OBJECTIVE 5:

Criteria:

The licensee must implement procedures to ensure that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

On inspection,11 of 73 teletheraov licensees failed to meet Obiective 5:

LLNL Review Findinos:

When compared to the LLNL review of the initially submitted written QMPs, 3 licensees had written procedures, as reviewed by LLNL, but apparently did not implement them.

5 licensees, who did not meet the objective upon inspection, did not meet the objective in the written QMP.

3 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

Procedures that the licensee must have implemented include, but were not limited to:

1. Maintain Record of Administration:

3 licensees did not implement procedures to maintain records of administration in an auditable form.

2. Procedures implemented to identify " unintended deviations":

3 licensees did not implement procedures to identif y unintended deviations from the written directive.

52

^

i i

)

3. Procedures to Evaluate and Respond to Recordable events and ' i

Misadministrations Within 30 Days of Discovery

i i

j Tl Review Findenas:

12 licensees did not implement procedures to evaluate and respond to recordable events and misadministrations.

LLNL Review Findinas

3 licensee had written procedures, as reviewed by LLNL, but apparently did not

, implement them. ]

1 l

} 5 licensees did not meet the objective for their written or implemented QMP. )

4 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

4. ' Procedures implemented to Gather the Relevant Facts and to identify and

} ,

implement Corrective Action to Prevent Recurrence:

I

! Tl Review Findinas:

) 10 licensees did not implement procedures to gather the relevant facts regarding recordable events and/or misadministrations, and to identify and implement corrective action to prevent recurrence.

i  !

! Periodic Review of the QMP: I

! l l Criteria: I I'

1 i The licensee shall develop procedures for and conduct a review of the QMP, including: l

a representative sample of all administrations; all recordable events; and all i

, misadministrations. These reviews shall be conducted at intervals of no greater than

. 12 months.

,. Tl Review Findnes:  !

! 41 licensees did not implement procedures that met the requirement.

I k 1. Expand The Review if Events Are identified: i

) 41 licensees did not implement procedures to expanded the review if recordable 1 events or misadministrations were identified.

i l

2. Determine Effectiveness

2 licensees did not evaluate their QMP after each review to determine the I

effectiveness of the program. i l

53 i

i i

( _ , _ . . _ . . _ - _ _ ._ _ _ . . _ . . _ _ _ _ _ _

3. Recordable Events: ,

3 recordable events were self-identified by the license since the last inspection.

4. 3 previously unidentified recordable events were identified by the inspector during the inspection of the licensee's implemented QMP.

5. Misadministrations:

1 misadministration was reported to NRC by the license since the last inspection.

No misadministrations identified by the license, were nqt subsequently reported to NRC.

LLNL Review Findinas:

26 licensee had written proce:dures, as reviewed by LLNL, but apparently did not implement them.

5 licensees did not meet f.he objective for their written or implemented QMP.

10 licensee's initially submitted QMPs were apparently not reviewed by LLNL.

54

i GAMMA STEREOTACTIC RADIOSURGERY inspection of implemented QMP:

Five sets of Gamma Stereotactic radiosurgery (gamma Knife) Tl field notes were entered into the database. One facility had been inspected (and entered) twice.

Therefore, the total number of QM inspections included is four.

Review of Written QMP:

During the contracted review of the initially submitted written QMPs, LLNL reviewed 3 gamma knife QMPs. However, only 2 of the 4 implemented QMPs inspected, had been previously reviewed by LLNL.

l  ;

i Written Directives:

1 The total number of written directives for these 4 licensees, over a 2-year period, was 694.

l QMP Review Findngs: -

i I

The following is a review of the findings of the inspection of the implemented QMPs 1 (QM Tl), compared to the LLNL findings of the review of the written QMPs. The LLNL data provided in each response, matches the specific QMP findings provided by the Tl (same population).

Obiective 1:

Criteria:

As described in 10 CFR 35.2, a written directive for gamma stereotactic radiosurgery must include the target coordinates, collimator size, plug pattern, and total dose.

Tl Review Fmdinas:

On inspection, All inspected imolemented QMP met Obiective 1.

LLNL Review Findings:

When compared to the LLNL review of the initially submitted written QMPs:

The 2 submitted written QMPs met Objective 1.

55

Q&lECTIVE 2:

Crtteria:

The licensee must implement procedures to ensure that, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive.

TI Review Findinas:

All inspected implemented QMPs met Objective 2.

LLNL Findinos:

The 2 submitted written QMPs met Objective 2.

OBJECTIVE 3:

Criteda:

The licensee must implement procedures to ensure that final plans of treatment and related calculations are in accordance with the respective written directive. Since acceptance testing of new and/or repaired equipment is not specifically required, licensees who did not have procedures for acceptance testing, but implemented other applicable procedures, met the objective.

TI Review Findings:

On inspection,1 of 4 aamma knife licensees failed to meet Obiective 3.

LLNL Review Findings:

When compared to the LLNL review of the initially submitted written OMPs, The licensee that failed to meet Objective 3, had not been reviewed by LLNL.

Procedures that the licensee may have implemented (several are requirements

'elsewhere in Part 35) include, but were not Emited to:

56

l ,

t i

l

1. Preparation of Treatment Plans:

A plan of treatment is prepared in accordance with the written directive.

l Tl Review Findinas:

l All inspected licensees implemented procedures to assure that a treatment plan l was prepared.

The 2 submitted written QMPs met the objective.

2. Check of Calculations:

Perform a check of the treatment calculations (whenever possible by another qualified individual) before beginning treatment.

Tl Review Findinas

1 licensee did not implement procedures to check calculations.

l LLNL Review Findinas:

The licensee that failed to implement procedures to check calculations, had not been reviewed by LLNL.

The 2 submitted written QMPs met the objective.

l

! 2. Acceptance Testina: i Perform an acceptance test on new or repaired equipment.

Tl Review Findinos:

All inspected QMP implemented procedures to acceptance t.-st new or repaired equipmer.t.

I LLNL Review Findinas:

The 2 submitted written QMPs met the objective.

Assure Precision of imaaina and Localization:

1 licensee did not assure precision of imaging and localization (this includes j ensuring that imaging films are correctly centered and labeled; and that the i stereotactic frame is aligned and correctly affixed.

Verify That the Correct Helmet and Plua Pattern:

j 1 licensee did not verify that the correct helmet and plug pattern were selected.

l l

l l

57

Verify Correct Data Entry:

All licensees verified that computer generated dose calculations were correctly entered into unit and that the computer print out shows correct data for the patient were used in the calculations I

1 Obiective 4:

Criteria:

The licensee must implement procedures to verify, prior to administration, that the

)

specific details are in accordance with written directive.

l TI Review Findings:

On inspection,1 of 4 aamma knife licensees failed to meet Obiective 4.

l LLNL Review Findnes: '

The licensee that failed to meet Objective 4, had not been reviewed by LLNL.

Procedures that ths licensee may have implemented (several are requirements elsewhere in Part 35) include, but were not limited to:

1. Confirmation of Treatment Plans:

Person adm!nistering treatment confirms the written directive including the i prescribed target coordinates, collimator size, plug pattern, and total dose prior l to administration.

Tl Review Findinas.

All inspected licensees implemented procedures to confirm treatment plans. i l

LLNL Review Findinos: )

i The 2 submitted written QMPs met the objective. l l

l 58

i

2. Confirm Administration Parameters:

Licensees implements procedures to verify the parameters of the treatment plan, ,

at a minimum, assure that the stereotactic frame coordinates on the  !

patient's skull match the plan of treatment. <

l l

Tl Review Findinas:

1 licensee did not implement procedures to confirm administration parameters.

l 3. Prompt Recordina of Treatment PararntitH:

1 i

l Tl Review Findinas:

l 1 licensee did not implement procedures for the prompt recording of the

! treatment parameters, and signing or initialing in the patient's chart or record.

LLNL Review Findinas:

The same licensee that did not implement procedures for the prompt recording of the treatment parameters, and signing or initialing in the patient's chart or record, had not been reviewed by LLNL.

The 2 submitted written QMPs met the objective.

OBJECTIVE 5:

Criteria:

i The licensee must implement procedures to ensure that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

i On inspection.1 of 4 aamma knife licensees failed to meet Obiective 5:

LLNL Review Findinas:

l The licensee that failed to meet Objective 4, had not been reviewed by LLNL.

l l

l l

[

i s 59 f

f f

l Procedures that the licensee must have implemented include, but were not limited to: ,

1. Maintain Record of Administration:

r 1 licensee did not implement procedures to maintain records of administration in an auditable form.

Procedures implemented to identify " unintended deviations":

1 licensee did not implement procedures to identify unintended deviations from the written directive.

2. Procedures to evaluate and respond to recordable events and misadministrations l within 30 days c' discovery:

Tl Review Findinas:

1 licensee did not implement procedures to evaluate and respond to recordable events and misadministrations.

LLNL Review Findinas:

The same licensee was not reviewed by LLNL.  ;

3. Procedures implemented to cather the relevant facts and to identify and implement corrective action to prevent recurrence:

Tl Review Findinos:

1 licensee did not implement procedures to gather the relevant facts regarding recordable events and/or misadministrations, and to identify and implement corrective action to prevent recurrence.

Periodic Review of the QMP:

Criteria: ,

The licensee shall develop procedures for and conduct a review of the QMP, including: ,

a representative sample of all administrations; all recordable events; and all

• misadministrations. These reviews shall be conducted at intervals of no greater than 12 months.

60  ;

l

. - . ~ - - - - . - -._ . _ .

l TI Review Findinos: i i

1 licensee did not implement procedures that met the requirement:  ;

Recordable Events:

l No recordable events were self-identified by the licenses since the last l inspection.

1 No recordable events were identified by the inspector during the inspection of j the licensee's implemented QMP. 1 1

Misadministrations:

No misadministrations were reported to NRC by the license since the last inspection.

LLNL Review Fmdinas:

1

1. licensee had written procedures to perform a review of the QMP, but apparently did not implement them.

I l

l 61

+ ^e

~

SUMMARY

DATA  !

Total Number of Licensees inspected: 883, representing 1668 modalities.

lodide Radiopharm 8rachytherapy HDR Teletherapy ST-90. GKnife >

Eye app.

No. of Tis received: 730 548 .311 156 81- . 72 5. ,

Number of facilities '

inspected 2 TIMES: 64 61 45 46 8 9 1 Number of separate facilities ,

inspected under this Tl for 666 487 266 109 73' 63 4 this modality:

Number of written QMP I

reviewed by LLNL for this 1568 1019 520 101 129 0 3 modality.  ;

Number of written OMP '

(from Tl implementation 491 418 230 82 63 0 2 sample) reviewed by LLNL-

-t

~

Approx. number of Written Directives prepared (total of Total: Total: Total: Total: Total: Total: Total:  ;

2 years, in response to 2 - 39819 4992 8499 10000 9407 2341 694 questions: "How many for current year (1), and How '

many previous year (2)):'

• On many of the Tis, the years were summed and written in one column, therefore, an accurate estimate for each year f was not possible.  ;

I

[

62  ;

{

i

. . _ _ _ . . _ _ _ _ _ . . _ _ . _ _ _ _ . _ _ _ .- _m.m..____.-____m_--_._____. _ _ _ _ _ _ -_.m___ .m____.________m- - _ _ _ _ _ _ _ . _ . _ _ _ _ __ _ _ _ . _ _ - ___-.n ..v-._..m> -

.-- .. --__m*m ,_ ,- - --.e-_-.

_ _ . . . . . . - -- .. _ .-._ . . _ _ _ . _ . _ _ . _ ~ . ..._.-. __

~

i INSPECTION FINDINGS t

Sodium lodide Radiopharma- HDR Brachytherapy Sr-90 Eye Teletherapy Total Each ceutical applicator Modality Therapy Number cf licensees - 666 487 109 266 63~ 73 *1668 Included for this modality ,

r Number of written directives prepared (total 39819 4992 10000 8499 2341 9407  ;

for 2 years)

Missed Objective 1 6% (37) 10% (48) 6% (7) 4% (11) 16 % (10) 15% (11) 7% (124)

Missed Objective 2 1% (7) 7% (32) 2% (2) .4% (1) All met 3% (2) ,3% (44) -

Missed Objectivn 3 N/A N/A 3% (3) 5% (14) 14 % (9) 41 % (30) - *11% (57)

Missed Objective 4 7% (46) 11 % (53) 6% (7) 5% (13) 18% (11) 14% (10) 9 % (141)

Missed Objective 5 16% (109) 21 % (100) 20 % (22) 13 % (35) 22 % (14) 15% (11) 18 % (292)

Did not conduct an 25% (166) 32% (155) 23 % (25) 24 % (65) 49 % (31) 56 % (41) 29 % (483) adequate review of the QMP at 12 mo. intervals Self-identified recordable 7% (46) 5% (22) 6% (7) 5% (13) 2% (1) 4% (3) events inspector identified 2% (16) 2% (8) 2% (2) 1% (3) 2% (1) 4% (3) recordable events

' The divisor for Objective 3 is 515 (Total minus lodides and RPT (N/A)), instead of 1668 (Total, all modalities) 63  :

i

'I

[

i l

l l

l ENFORCEMENT DATA I

Sodium Iodide Radiopharmace Brachytherapy HDR Sr-90 Eye Teletherapy utical Therapy Applicator Misadministrations 28 12 40 18 4 23 Misadministrations resulting m 10 2 17 8 2 17 EnSrcement Severity Levels 1 SL 1 1 SL1 1 SL 1 3 SL 2 1 SL 2 5 SL 3 1 SL 3 10 SL 3 2 SL 3 1 SL 3 17 SL 3 1 SL 4 2 SL 4 3 SL 4 1 SL 4 Severity Levels 1 and 2 (Sodium lodide): In each case, the wrong dosage was administered by a technologist without a written directive from an authorized user. Resulted in significant thyroid doses.

Severity Level 1 (Brachytherapy): 112 seeds, with activity 10 times that which was ordered were implanted into a patients prostate. The seed activity was not verified before being implanted.

Resulted (n several attempts to surgica!!y remove the seeds.

Severity Level 2 (Brachytherapy): A data en*iy error lead to a 40% underdose.

Severity Level 1 (HDR): Treatment interrupted, source inadvertently left in patient. Resulted in patient death.

64 u,__.a--..- --,--,-,.----.----.----------------------__a----,--,-a___---_-____4 - - - - + = m ,c-,w-m~ n

SODIUM IODIDE l-125 or 1-131 > 30 pCi

SUMMARY

OF FINDINGS:

Number of Tl Field Notes included for this modality: 666 10 CFR 35.32(a), (b), and (c): Inspection of Written OMP Review Findings (LLNL),

Failed to implement procedures for: Implemented (TI) That Did Not Meet Objective on the TI: i Did Not Not Met Obj. Meet Reviewed OBJECTIVE 1: 37 of 666 TI 9 10 18 A written directive (order for a specific patient, dated & responses did not met the did not meet not reviewed sinned by authorized user (a.u.) or physician under meet objective objective the objective supervision of an a.u.) is prepared for each patient 135.32(a)(1)l:

OBJECTIVE 2: 7 of 666 Tl 1 1 5 Licensee uses mco e ' one method to verify the responses did not met the did not meet not reviewed patient's identity  ?!ta)(2)]: meet objective objective ti e objective OBJECTIVE 3 Procedures implemented to verify that final plans of Not applicable treatment and related calculations are in accordance with written directives: ,

OBJECTIVE 4 46 of 666 TI 7 25 14 Procedures implemented to verify, prior to administration, responses met the did not not reviewed that the specific details are in accordance with written did not meet objective meet the directive (35.32(a)(4)l: objective objective OBJECTIVE 5 109 of 666 Tl 16 59 34 Procedures implemented to ensure that unintended responses did not met the did not not reviewed deviations are identified, evaluated, and corrective action meet objective objective meet the taken 135.32(a)(5)l: objective 65 t

.._m_ .m.___.__ _ _ . . ._..____ ._.-_-____.______.___ _ _..____________._____._...._. _ ___ _ _.____ _ _ __ _ _ _ _ ______ _ _ __ _ _

u_m m__

SODIUM IODIDE l-125 or 1-131 > 30 pCi, Summary of Findings (Continued)

Review conducted of the QMP at intervals no greater 166 of 666 Tl 72 45 49 than 12 months 135.32(b)(1)] responses did not met the did not not reviewed meet requirement requirement meet the requirement Recordable event (s) self-identified since the 46 last inspection (35.32(c), 35.21 Recordable events identified by inspector 16 135.32(c), 35.2] _ _ _

Lices. ee reported misadministration (s) since the last 8 inspection 135.33(a)]

Licensee identified misadministrations that were not 1 subsequently reported 135.33(all h

66 ,

b

. 1 RADIOPHARMACEUTICAL THERAPY

SUMMARY

OF FINDINGS:

Number of Tl Field Notes included for this modality: 487

• 10 CFR 35.32(a), (b), and (c): IneW of Written OMP Review Findings (LLNL),

Failed to implement procedures for: " . " _ .ated (TI) That Did Not Meet Objective on the TI:

Did Not Not Met Obj.- Meet Reviewed j OBJECTIVE 1: 48 of 487 Tl 8 28 12 A written directive (order for a specific patient, dated & responses did not met the did not meet not reviewed sinned by authorized user (a.u.) or physician under meet objective objective the objective  ;

I supervision of an a.u.) is prepared for each patient 135.32(a)(1)l:

4 OBJECTIVE 2: 32 of 487 Tl 19. 4' 9 Licensee uses more than one method to verify the responses did not met the did not meet not reviewed patient's identity [35.32(a)(2)l: meet objective objective the objective 1

OBJECTIVE 3 Procedures implemented to verify that final plans of Not applicable .;

treatment and related calculations are in accordance with written directives: ..

OBJECTWE 4 53 of 487 Ti 23 15 15 Procedures implemented to verify, prior to administration, responses did not met the did not meet not reviewed .

that the specific details are in accordance with written meet objective objective the objective-directive [35.32(a)(4)l

OBJECTIVE 5 100 of 487 Tl 74 9 17 Procedures implemented to ensure that unintended responses did not met the did not meet not reviewed deviations are identified, evaluated, and corrective action meet objective objective the objective taken (35.32(a)(5)l:

67 i

w

..__.m.. _ _ _ __-. . .__m___ _ _ . . _ ,

u____- _ _ _ _ _ _mu._ ___m-r=. _ --- ,, + m w- ,rr- - - .-r+-,vw-

Radiopharmaceutical Therapy, Summary of Findings (Continued)

Review conducted of the OMP at intervals no greater 155 of 487 Tl 55 76 24

• than 12 months [35.32(b)(11] responses did not met the did not meet not reviewed meet requirement requirement the requirement Recordable event (s) self-identified since the 22 last inspection [35.32(c), 35.2)

Recordable events identified by inspector 8 135.32(c), 35.21 Licensee reported misadministration (s) since the last 1 inspection 135.33(all Licensee identified misadministrations that were nql 3 subsequently reported 135.33(a)]

9 b

68 4

_ _ _ _ _ _ . _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ . - _ _ _ _ _ _ . _ _-- ._.___._______m_

- - - _ _- _ _ _ . + - -- - - , - - -_ _ _ _ _ _ . _ __ _ .

i HIGH-DOSE-RATE REMOTE AFTERLOADER BRACHYTHERAPY j t

SUMMARY

OF FINDINGS: i Number of Tl Field Notes included for this modality: 109 10 CFR 35.32(a), (b), and (c): Inspection of Written OMP Review Findings (LLNL),

Failed to implement procedures for: Implemented That Did Not Meet Objective on the TI: '[ i (TI) Did Not Not Met Obj. Meet Reviewed  ;

OBJECTIVE 1: ~ 7 of 109 T1 2 4 1 A written directive (order for a specific patient, dated & responses did met the did not meet not reviewed  ;

sinned by authorized user (a.u.) or physician under not meet objective the objective i supervision of an a.u.) is prepared for each patient objective  !

135.32(a)(1)l: j OBJECTIVE 2: 2 of 109 Tl 1 1 Licensee uses more than one method to verify the responses did none met did not meet not reviewed [

patient's identity 135.32(a)(2)l: not meet the objective the objective l objective i

OBJECTIVE 3 3 of 109 Tl -1 2 Procedures implemented to verify that final plans of responses did none met did not meet not reviewed ,

treatment and related calculations are in accordance with not meet the objective the objective

written directives

objective ,

OBJECTIVE 4 7 of 109 TI 5 2 i Procedures implemented to verify, prior to administration, responses did met the none did not not reviewed [

! that the specific details are in accordance with written not meet objective meet the

' directive [35.32(a)(4)l: objective objective i

i i  !

r 69 ' +

i

High-Dose-Rate Remote Afterloader Brachytherapy Summa'ry of Findings (Continued)

OBJECTIVE 5 22 of 109 Tl 9 6 7 Procedures implemented to ensure that unintended responses did met the did not meet not reviewed deviations are identified, evaluated, and corrective action not meet objective the objective taken 135.32(a)(5)): objective Review conducted of the QMP at intervals no greater 25 of 109 Tl 10 8 7 than 12 months (35.32(b)(1)] responses did met the did not meet not reviewed not meet requirement the requirement requirement Recordable event (s) self-identified since the 7 last inspection (35.32(cf . 35.21 Recordable events identified by inspector 2

[35.32(c), 35.2]

Licensee reported misadministration (s) since the last 1 inspection 135.33(a)]

Licensee identified misadministrations that were n_qi O ,

subsequently reported 135.33(all l

l l

I 70 4

l

Brachytherapy

SUMMARY

OF FINDINGS:

Number of Tl Field Notes included for this modality: 266 10 CFR 35.32(a), (b), and (ct: Inspection of Written OMP Review Findings (LLNL),

Failed to implement procedures for: Irnplemented That Did Not Meet Objective on the TI:

(Til Did Not Not Met Obj. Meet Reviewed OBJECTIVE 1: 11 of 266 Tl 5 4 A written directive (order for a specific patient, dated & responses did met the did not r,teet 1 sianed by authorized user (a.u.) or physician under not meet objective the obiective not reviewed supervision of an a.u.) is prepared for each patient objective 135.32(a)(1)l:

OBJECTIVE 2: 1 of 266 Tl 1 Licensee uses more than one method to verify the responses did none met did not meet patient's identity 135.32(a)(2)l: not meet the objective the objective objective OBJECTIVE 3 14 of 266 Tl 3 7 4 Procedures implemented to verify that final plans of responses did met the did not meet not reviewed treatment and related calculations are in accordance with not meet objective the objective written directives: objective OBJECTIVE 4 13 of 266 Tl 5 5 3 Procedures implemented to verify, prior to administration, responses did met the did not meet not reviewed that the specific details are in accordance with written not meet objective the objective directive [35.32(a)(4)l: objective OBJECTIVE 5 35 of 266 Tl 10 22 3 Procedures implemented to ensure that unintended responses did met the did not meet not reviewed deviations are identified, evaluated, and corrective action not meet objective the objective taken [35.32(a)(5)]: objective 71

Brachytherapy Summary of Findings (Continued)

Review conducted of the QMP at intervals no greater 65 of 266 Ti 26 6 than 12 months 135.32(b)(1)] responses did met the did not meet not reviewed not meet requirement the requirement requirement Recordable event (s) self-identified since the 13 last inspection 135.32(c) 35.21 Recordable events identified by inspector 3 135.32(c), 35.2]

Ucensee reported misadministration (s) since the last 2 inspection [35.33(all Ucensee identified misadministrations that were no.t 2 subsequently reported 135.33(all 72 6

- - - - - - - - - - - - - . _ _ _ _ _ _ _ _ _.____m __-e ,-

STRONTIUM-90 EYE APPLICATOR ,

BRACHYTHERAPY

SUMMARY

OF FINDINGS:

Number of TI Field Notes included for this n;c tality: 63

• Written OMP for Strontium-90 Eye Applicators were not reviewed by Lt.NL 10 CFR 35.32(a), (b), and (c): Inspection of Failed to implement procedures for: Implemented (TI)

OBJECTIVE 1: 10 of 63 A written directive (order for a specific patient, dated & responses did not meet signed by authorized user (a.u.) or physician under objective supervision of an a.u.) is prepared for each patient  ;

135.32(a)(1)l:

OBJECTIVE 2: All Tl responses met Licensee uses more than one method to verify the the objective patient's identity [35.32(a)(2)]: +

OBJECTIVE 3 0 of 63 Tl l Procedures implemented to verify that final plans of responses did not meet treatment and related calculations are in accordance with objective >

written directives:

OBJECTIVE 4 11 of 63 Tl Procedures implemented to verify, prior to administration, responses did not meet that the specific details are in accordance with written objective directive [35.32(a)(4)l:

OBJECTIVE 5 14 of 63 Tl Procedures implemented to ensure that unintended responses did not meet deviations are identified, evaluated, and corrective action objective taken [35.32(a)(5)l:

73

_ _ _ . . - _ _ _ . _ _ . _ . _ . _ . _ _ _ _ _ _ _ _ . _ . - _ _ _ _ _ _ _ . _ _ _ _ .-______.______.__.________m__m_____ -

__ __ _a.--. -- w __ _ _ -_____ - e-e_m__..____- __ ____ _ - _%__ -- m__ m _ _.__.a__ _ _ _ . _ ____-

Strontium-90 Eye Applicator, Summary of Findings (Continued)

Review conducted of the QMP at intervals no greater 31 of $3 Tl than 12 months 135.32(b)(1)] responses did not meet >

requirement t Recordable event (s) self identified since the "

last inspection 135.32(cl. 35.21 1 Recordable events identified by inspector 135.32(c), 35.21 1 .

Licensee reported misadministration (s) since the last inspection 135.33(all O Licensee identified misadministrations that were nqt subsequently reported 135.33(a)) O j

~

I i

i I

i I

i 74 t

TELETHERAPY

SUMMARY

OF FINDINGS:

Number of Tl Field Notes included for this modality: 73 10 CFR 35.32(a), (b), and (c): Inspe: tion of Written OMP Review Findings (LLNL),

Failed to implement procedures for: Implemented That Did Not Meet Objective on the TI:

(TI) Did Not Not Met Obj. Meet Reviewed OBJECTIVE 1: 11 of 73 TI 9 1 1 A written directive (order for a specific patient, dated & responses did met the did not meet not reviewed sianed by authorized user (a.u.) or physician under not meet objective the objective supervision of an a.u.) is prepared for each patient objective 135.32(a)(1)l:

OBJECTIVE 2: 2 of 73 Tl 1 1 Licensee uses more than one method to verify the responses did met the not reviewed patient's identity [35.32(a)(2)l: not meet objective objective OBJECTIVE 3 30 of 73 Tl 11 12 7 Procedures implemented to verify that final plans of responses did met the did not meet not reviewed treatment and related calculations are in a:cordance with not meet objective the objective written directives: objective OBJECTIVE 4 10 of 73 Tl 3 3 4 Procedures implemented to verify, prior to administration, responses did met the did not meet not reviewed that the specific details are in accordance with written not meet objective the objective directive (35.32(a)(4)l: objective OBJECTIVE 5 11 of 73 Tl 3 5 3 Procedures implemented to ensure that unintended responses did met the did not meet not reviewed deviations are identified, evaluated, and corrective action not meet objective the objective taken [35.32(a)(5)]: objective 75

Teletherapy Summary of Findings (Continued)

Review conducted of the QMP at intervals no greater 41 of 73 Tl 26 5 10 than 12 months 135.32(b)(1)] responses did met the did not meet not reviewed not meet requirement the  !

requirement requirement Recordable event (s) self-identified since the 3 last inspection [35.32(c), 35.21 Recordable events identified by inspector 3 135.32(c), 35.21 -

Ucensee reported misadministration (s) since the last 1 inspection 135.33(all Licensee identified misadministrations that were nql O subsequently reported 135.33(all 76 t_.___._:__ _ _ . _ _ _ _ _ _ . _ _ . _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ .- 1.--,.. ._ _ - - , . - , ._-- -

GAMMA STEREOTACTIC RADIOSURGERY .

SUMMARY

OF FINDINGS:

Number of Tl Field Notes included for this modality: 4 10 CFR 35.32(a), (b), and (c): Inspection of Written QMP Review Findings (LLNL),  !

Failed to implement procedures for: Implemented (TI) That Did Not Meet Objective on the TI:

Did Not Not Met Obj. Meet Reviewed OBJECTIVE 1: All 4 Ti 2 Ti 2 A written directive (order for a specific patient, dated & responses met responses not reviewed signed n _ by authorized user (a.u.) or physician under objective met the supervision of an a.u.) is prepared for each patient objective ,

135.32(a)(1)l:

OBJECTIVE 2: All 4 Ti 2 Ti 2 Licensee uses more than one method to verify the responses met responses not reviewed patient's identity 135.32(a)(2)]: objective met the objective ,

OBJECTIVE 3 1 of 4 Ti 2 Tl 2 <

I Procedures implemented to verify that final plans of responses did not response not reviewed treatment and related calculations are in accordance with meet objective met the j written directives: objective i i

OBJECTIVE 4 1 of 4 Tl 2 Tl 2  :

Procedures implemented to verify, prior to administration, responses did not response not reviewed that the specific details are in accordance with written meet objective met the directive 135.32(a)(4)]: objective ,

t i

L 77 i

. - _ . _ _ _ - _ . _ _ - _ _ _ _ _ _ - - . - _ _ _ . _ . _ - _ _ _ . _ _ . _ _ - _ . . - _ _ _ . _ _ - _ _ _ _ _ _ - - _ _ - _ _ _ _ _ _ _ _ . _ _ - . _ . _ _ - = ._m. -., - - , - ~ ,

Gamma Stereotactic Radiosurgery, Summary of Findings (Continued)

OBJECTIVE 5 1 of 4 Tl 1 Tl 1 2 Procedures implemented to ensure that unintended responses did not response did not meet not reviewed deviations are identified, evaluated, and corrective action meet the met the the objective taken 135.32(a)(5)]: objective objective Review conducted of the QMP at intervals no greater 1 of 4 Tl 1 Tl 1 2 than 12 months (35.32(b)(1)] responsc: did not response did not meet not reviewed meet requirement met the the requirement requirement Recordable event (s) self-identified since the O last inspection 135.32(c), 35.21 _ _ _ _

Recordable events identified by inspector O

[35.32(c), 35.2]

Licensee reported misadministration (s) since the last 0 inspection 135.33(all Licensee identified misadministrations that were not O subsequently reported 135.33(all 78 O

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l Attachment 1 ^

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L STANDARD REVIEW PLAN (SRP) ,

QUALITY MANAGEMENT RULE ,

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INTRODUCTION On July 2'5. 1991, the Federal Register published a revision to 10 CFR 35. The revision amends regulations governing therapeutic administrations of byproduct

~

material and certain uses of radioactive sodium iodide to require '

implementation of a quality management (QM) program. The program should be used to provide high confidence that the byproduct material or radiation from i the byproduct material will be administered as directed by an authorized user.  ;

The effective date of this rule is-January 27, 1992. Existing licensees, as ,

o applicable, submitted to the appropriate NRC Regional Office by this date a copy of the quality management program / plan and written certification that the plan has been implemented. Each applicant for a new license must submit a l

plan as part of their license application, although the review and acceptance of the submission will not be a licensing action. The following Standard l Review Plan (SRP) should be used by the NRC during review of the quality management program as required by 10 CFR 35.32.

The requirements for the QM program are a series of performance based  ;

objectives. The purpose of this SRP is to assure that the licensee's program,  !

if implemented, trovides reasonable assurance that the objectives will be met,  !

l and to identify potential areas of weakness or omissions, or clear or apparent violations in meeting these objectives. 4 The SRP is organized according to the objectives identified in 10 CFR 35.32, .

with further breakdown by treatment modality (e.g., radiopharmaceutical '

therapy, teletherapy, brachytherapy, or gamma stereotactic radiosurgury) used by the licensee for administering byproduct material or radiation from byproduct material. A checklist has been developed to be used with the SRP to aide in consistency between' plan reviews.

The licensee may orghaize its plan according to the program objectives or the type of modality. The license reviewer should review each plan for areas of apparent weakness or areas as outlined in their policy and/or l

procedures that may not meet the objectives for all licensed treatment modalities. In cases where additional information is necessary to review the plan for adequacy, the reviewer should reference NRC Regulatory Guide 8.33,

" Quality Management Program." Where appropriate, a reference to a specific

.section of the Regulatory Guide has been provided in brackets following each requirement. The reviewer is reminded that the Regulatory Guide should only be used as reference material and that the licensee may provide alternatives.

In these cases, it may be necessary for the reviewer to discuss the proposed alternatives with senior staff. Questions regarding licensee proposed

alternatives should be directed to NMSS, through regional management.

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T OBJECTIVE 1 - [10 CFR 35.32(a)(1)]

t That, prior to administration, a written directive is prepared for:  !

(i) Any teletherapy radiation dose; (ii) Any gamma stereotactic surgery radiation dose; (iii) Any brachytherapy radiation dose; (iv) Any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131; or (v) Any therapeutic administration of a ,

radiopharmaceutical, other than sodium iodide I-125 or I-131.

Seneral 4

1. The procedure should assure that an authorized physician user will  ;

prepare, date and sign a written directive prior to administration j provided the exemption described in Item 2 does not apply to the l administration.

(The reviewer should ask the licensee to provide either: a sample of a written directive, a procedure that describes the information required on

, a written directive, or a procedure that indicates the written directive l

will contain the information in 10 CFR 35.2) i The written directive should contain the following:

] RADIOPHARMACEUTICALS [ Reg. Guide 8.33 Section 1.1 and 10 CFR 35.2) 4 o Administrations greater than Dosage 30 uti of sodium iodide I-125 and 1-131 l I

o Therapeutic administrations of Radiopharmaceutical a radiopharmaceutical other than l Dosage '

4 sodium iodide I-125 and I-131 Route of administration TELETHERAPY [ Reg. Guide 8.33 Section 2.1 and 10 CFR 35.2)

Total dose, dose per fraction, treatment site and overall treatment period.

BRACHYTHERAPY - HIGH-DOSE-RATE REMOTE'AFTERLOADING DEVICES

[ Reg. Guide 8.33.Section 3.1.1 and 10 CFR 35.2)

Radioisotope, treatment site, and total dose.

2

-~ _ ._. _ _ - _ _ - _ _ __ _ . . __

"I BRACHYTHERAPY - ALL OTHER APPLICATIONS l

[ Reg. Guide 8.33 Section 3.2.1, 3.2.8, 3.2.9, and 10 CFR 35.2]

Prior to administration, the licensee must document the radioisotope, number of sources, and source strengths. i l After implementation, but prior to completion of the procedure: the  !

l licensee must document the radioisotope, treatment site, and total source  !

l strength and exposure time (or, equivalently, the total dose).

GAMMA STERE 0 TACTIC RADIOSURGERY  !

l [ Reg. Guide 8.33 Section 4.1, 4.3, and 10 CFR 35.2]  ;

Target coordinates, collimator size, plug pattern and total dose.  !

l 2. The procedure should indicate that oral directives will be accepted only  ;

when a delay in order to provide a written directive would jeopardize the i l patient's health. [ Reg. Guide 8.33 Section 5.]  !

l The procedure should also instruct that information contained in the oral directive will be documented immediately in the patient's record and a written directive will be prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of i

the oral directive. [ Reg. Guide 8.33 Section 5.]

i (Reviewer should examine the procedure to ascertain that the instruction is included.)

l 3. The licensee's procedure should include instructions that revisions to a l l written directive will be handled in one of the following manners:

l a. Written revision to existing written directive

! [ Reg. Guide 8.33 Section 5.]

1. The revision must be dated and signed by an authorized user prior to the administration of the radiation dose,

b. Oral revision to existing written directive

[ Reg. Guide 8.33 Section 5.]

1. An oral revision will only be accepted when because of the patient's condition, a delay in order to provide the written revision would jeopardize the patient's health.

2. The oral re' vision will be documented in the patient's record and a revised written directive will be signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

(Reviewer should ascertain that this instruction is part of the licensee's

implementing procedures.)

Ob.iective 2 - [ Reg. Guide 8.33 Section 10 CFR 35.32(a)(2)]

That prior to each administration, the patient's identity is verified by more than one method as the individual named in the written directive.

Generso

1. The procedure should assure that the licensee will verify the patient's identity by more than one method prior to administration. [ Reg.

Guide 8.33 Section 1.2, 2.2, 3.1.2, 3.2,2, and 4.2)

The licensees implementing procedures should indicate this requirement to staff and describe possible methods to verify patient identification.

(Reviewer should examine the licensees implementing procedure and assure that the licensee has committed to Objective 2 and provides guidance to staff on the methods that will be used.)

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. _. . _ _ . _ ~ . - _ , _ _ _ - _ - _ _ . _ . . _

i j Ob.iective 3 - [10 CFR 35.32(a)(3)] )

(not applicable to radiopharmaceutical therapy)

' That final plans of treatment and related calculations for i brachytherapy, teletherapy, and gamma stereotactic l radiosurgery are in accordance with the respective written l directives. l

! General t

1. The procedure should assure that:

i a. a plan of treatment will be prepared in accordance with the l respective written directive. [ Reg. Guide 8.33 Section 2.3. -

3.1.3, 3.2.5, and 4.5]

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i b. related calculations (dose) are in accordance with the written i riirective. (see #3 references]

2. The reviewer should review the implementing procedures which may include I

the following and the qualifications of the individual performing or i verifying the following tasks: '

a. Computerized generated dose calculations are checked,

[ Reg. Guide 8.33 Section 2.8, 2.12,3.1.6, 3.1.8, 3.2.7, 3.2.10, 3.2.12, 4.6, 4.7, and 4.9) i

b. Acceptance tests will be' performed on each treatment planning or i

dose calculating computer program that could be used for dose j calculations, (Reg. Guide 8.33 Section 2.13, 3.1.9, 3.2.13, and 4.10]

c. Specific modality requirements:

TELETHERAPY

1. Full calibration measurements after source replacement or when l spot check output differs by greater than 5%, are independently checked, (Reg. Guide 8.33 Section 2.9) l

2. Transmission factors for beam modifying devices are determined,

[ Reg. Guide 8.33 Section 2.10]

3. Physical measurements of the teletherapy output should be made -

for treatment parameters not addressed in the most recent full j calibration measurement. [ Reg. Guide 8.33 Section 2.11]

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l-ALL BRACHYTHERAPY

1. Position of dumy sources or fixed geometry applicators are verified prior to inserting sealed sources. [ Reg. Guide 8.33 Section 3.1.5,3.2.6,and3.2.7]

(Reviewer should ensure that the licensee has procedures that address all modalities of their program.)

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l Objective 4 - [10 CFR 35.32(a)(4)]

That each administration is in accordance with the written directive Genera 1 1

The licensee has procedures to confirm that, prior to administration, the -

specific details of the administration are in accordance with the written directive. [ Reg. Guide 8.33 Section 1.3, 2.4, 3.1.3, 3.2.3, and 4.5] (The implementing procedures for objectives 1 through 3 should serve to ensure compliance with objective 4.)

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i Ob.iective 5 - [10 CFR 35.32(a)(5)]

That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

General The procedures should describe the methods used to identify and evaluate any '

unintended deviations from a written directive and the corrective actions that will be taken after the deviation has been identified. [10 CFR 35.32(a)(5)]

The procedures should be modality specific, for example, for teletherapy the procedure should include a review of daily and cumulative teletherapy dose administrations from all treatment fields. [ Reg. Guide 8.33 Section 2.7] '

(Reviewer should ascertain that the licensee's implementing procedure addresses this objective for all modalities used.)

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• l Annual Prooram Review - [10 CFR 35.32(b)]

1. The licensee should address the performance of a program review. [10 CFR 35.32(b)(1)(iii) and Reg Guide 8.33 Sections 1.6, 2.14, 3.1.10, 3.2.14, 4.11, and 6.] l

2. The implementing procedures should include:

a. Review of a representative sample of randomly selected patient administrations, all recordable events, and al? misadministrations. .

[10 CFR 35.32(b)(1)] I

b. A description of the licensee's methods for selecting a representative sample of patients. [10 CFR 35.32(b)(1)(1)]

(A representative sample may be selected using the acceptance '

sampling tables of 10 CFR 32.10 or should include (at a minimum):

20% if the number of cases performed is greater than 100, 20 cases '

if the number of cases is between 20 and 100, and all, if the number of cases is less than 20.)

c. The licensee should commit to evaluate each of the reviews to determine the effectiveness of the quality management program and if ,

necessary, make modifications to meet the objectives of the program.

[10 CFR 35.32(b)(2)]

d. The procedure should note that modifications to the quality management program should be submitted to the NRC within 30 days after the modification has been made. [10 CFR 35.32(c)]

e. The procedure should note that records of each review and evaluation will be maintained for three years. [10 CFR 35.32(b)(3)]

(Reviewer should ensure that the licensee makes a written commitment to an annual review that includes the above.)

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Record of Administration - 10 CFR 35.32(d)(2)

1. The procedure should require that a written record of each administered radiation dose or radiopharmaceutical dosage will be maintained for three years after the date of administration. [ Reg. Guide 8.33 Section 1.5, 2.6,3.1.7,3.2.8,3.2.9,3.2.11,4.8]

(Reviewer should assure that the policy / procedure contains this commitment and/or instruction to the staff.)

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ACTION PLAN ,

IMPLEMENTATION OF THE QUALITY MANAGEMENT RULE 10 CFR 35.32  !

t Responsibilities

1. LICENSEE i l

a. Submit Quality Management Plan (QM Plan), if applicable, and letter stating that it will implement the Plan by January 27, 1992.

b. Implement the QM Plan.

2. REGION l

a. Note in the LTS System that a licensee has submitted a QM plan.

b. Identify a regional contact for the NMSS Project Manager (PM)

(Sally Merchant -504-2637) and the contractor.

c. Provide a list of the licenses that are planned or due for l inspection during the next year sorted by month. Yearly lists  !

should be submitted to the NMSS PM 3 months prior to the first inspection scheduled on the list. Changes to the list are to be submitted to the NMSS PM monthly.

d. Assist Headquarters PM in preparing standard paragraphs and format. i to be used by the contractor in preparing response letters to  !

licensees.

e. Transmit response letters, prepared by the contractor, to licensees. There are three possible outcomes for the reviews.

The program: (a) appears to meet the requirements of 10 i!R 35.32; (b) is inadequate due to omissions or weaknesses in the program; or (c) contains an apparent or clear violation. Licensees are not ,

required to respond to items a and b. A resoonse is reauired for item (c). Plans that were reviewed by the contractor will be reviewed by the inspector at the next inspection.

f. Provide copies of licensees' response letters to Headquarters PM and to the contractor in the following manner:

1. A copy of a licensee response to a NRC letter stating that their plan " appears to meet the requirements in 10 CFR 35.32" should be sent.to the NMSS PM, the original letter should be filed.

(Since these NRC letters require no response, there should be l few, if any, responses).

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2. Copies of a licensees' response to an NRC letter stating that their plan has " weaknesses and/or omissions" should be sent to ,

the NMSS PM and the contractor. The original should be filed.*

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3. Copies of licensees' resubmission of QM plans sent as a result i of an NRC letter citing clear or apparent violation (s) must be sent to the NMSS PM and to the contractor for re-review. The  :

original should be filed along with the licensees' first plan l

• The first plan is not discarded until the second plan is. ,

accepted. i i

g. Review implementation of the QM p1an (NRC inspector) during a routine or reactive inspection at the licensee's facility (if l

possible after the plan has been reviewed by the contractor) including items identified by the contractor in the letter i transmitted to the licensee.

l Any deficiencies related to 10 CFR 35.32 requirements should be identified in the inspection report, notice of violation, or on Form 591. During the period of January 27, 1992 to January 27, 1995, send a ccpy of the report, letter, or Form to the NMSS PM.

Note: NRC inspectors should verify, during an inspection, that the ,

facility, if required, has submitted a QM Plan. If a Plan has not been sute.itted to the NRC, the inspector should issue a violation against 35.32(a). >

h. Keep the NMSS PM informed of any significant action taken at a licensee that pertains to the QM Rule.

i ~.. Keep an informal list of licensee questions related to the QM Rule for periodic transmittal to NMSS PM.

L. RISJt

a. Prepare standard par $grcphs and format to be used by the contractor in preparv.9 reconnse letters to' licensees.

1

b. Provide the contact at cich region to the contractor, and the l quarterly list of licensees that are due for inspection during the i next quarter (by region) to the' contractor.  !

c. Keep contractor informed of any inspection actions taken at a  !

specific facility with regards to a.QH Plan.

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d. Provide training to the contractor on the QM Rule, Regulatory Guide 8.33, and the Standard Review Plan.

e. NMSS PM will audit representative sample of contractor reviews.

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L CONTRACTOR

a. Develop an accountability system to track the status of each QM i review.

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b. Contractor will go to the Regions to make copies of the QM Plans  !

and the licenses. j

c. Review all QM Plans in accordance with the Standard Review Plan developed by NMSS. All plans must be reviewed within 13 months of the' contract start date. The schedule used to identify plans for review should be based on the inspection schedule provided by the NMSS PM.

d. Based on the review, the contractor will take one of the following actions:  !

(a) If the initial licensee submittal appears to meet the objectives of 10 CFR 35.32, the Contractor shall provide the i following to the Regional PM within 10 business days of the l plan review: )

o Completed SRP checklist for each plan, and o Proposed letter

• on appropriate Regional letterhead that the plan appears to meet the  !

requirements of 10 CFR 35.32. The letter will '

be provided in the form of a paper copy and electronic media using Word Perfect Version 5.0 or 5.1 The letter will not require a i response from the licensee.

b. If the initial licensee submittal does not meet the objectives of 10 CFR 35.32 because of apparent weaknesses and/or omissions in the program, the contractor shall provide the following documentation to the Regional PM within 10 business days of the initial review:

o A proposed letter

• on appropriate Regional letterhead, suitable for transmittal to the licensee, that lists the weaknesses and/or omissions in the QM Plan. The letter shall be provided in the form of a paper copy and electronic media using Word Perfect Version 5.0 or 5.1 The letter will not require a response from the licensee.

o A copy of the SRP checklist that identifies the weaknesses and/or omissions in the program.

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c. If the initial licensee submittal does not meet the I objectives of 10 CFR 35.32 because of apparent or clear violations, the contractor shall provide the following j documentation to the Regional PM within 10 business days of l the initial review.  ;

o A proposed letter

• on the appropriate NRC Regional

' letterhead suitable for transmittal to the licensee, that lists the apparent or clear violations in the QM Plan. The letter shall be provided in the form of a paper copy and electronic media using Word Perfect Version 5.0 or 5.1 The letter will require a response from the licensee.

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• The letter will be prepared by the contractor using the '

standard paragraphs and format supplied by the NMSS PM.

The contractor will provide a copy to the NMSS PM. l l

d. Provide to the NMSS PM an overall summary report which meets the objective in the Statement of Work.

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ATTACHMENT A INTERIM FIELD NOTES  :

, OUALITY MANAGEMENT (0M) PROGRAM l

[ Note "Yes" and "No" answers may indicate a " Weakness (W)" or " Substantial l l

Weakness (SW)" based on their significance. If the question is not ,

applicable, indicate "NA")

! 1. GENERAL  !

a. License number (s):

b. Docket number (s):

c. Last inspection date(s):

d. Current inspection date(s):

2. MODALITIES )

\

l l a. Procedures the licensee performs:

(1) Teletherapy Y N l (2) Gamma Stereotactic Radiosurgery Y N l

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y N (4) All Other Brachytherapy Y N (5) Na! I-125 or I-131 >30 microci Y N (6) Therapeutic Radiopharmaceutical Other Than (5) Y N

3. PROGRAM

a. Licensee has a written QM program, as applicable, that covers all policies / procedures that require a written directive and program review [35.32(a) and (b)(1)] Y N (SW)

b. Written QM program and certification (for existing licensee) submitted to NRC [35.32(f)(2)] Y N

, Date

c. Recent version with latesc modifications submitted to NRC [35.32(e)] Y N Date Remarks

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4. SUPERVISION

a. Supervised individual (s) instructed in the QM program applicable to the modality of use [35.25(a)(1)] Y N (SW)

(1) If any individual (s) has not received training, document their name and position. Additionally, briefly describe the reasons as stated by the individual, the RSO, and the supervising authorized user:

Remarks:

5. SAMPLING

a. Determine the number of administrations Total Target

• No.

to sample and review: Admin. Sample Reviewed

• Refer to Appendix: Table I and II (1) Teletherapy (2) Gamma Stereotactic Radiosurgery (3) High-Dose-Rate Remote Afterloading Brachytherapy (4) All Other Brachytherapy __

(5) Nal 1-125 or I-131 >30 microci (6) Therapeutic Radiopharmaceutical Other Than (5)

Remarks:

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! 6. OBJECTIVES

[ Note - Under each modality for Section 6 (Objectives 1 and 2), I miss is considered as " Satisfactory (S), 2 misses indicates a " Weakness (W)", and 3 or more misses indicates a " Failure (F)" or " Substantial Weakness (SW)"]

OBJECTIVE 1

a. How many written directives, as applicable, were missing for the following administrations

[35.32(a)(1) and (d)(1)]: Misses S.W.SW l (1) Teletherapy (2) Gamma Stereotactic Radiosurgery (3) High-Dose-Rate Remote Afterloading Brachytherapy (4) All Other Brachytherapy (5) Na! I-125 or I-131 >30 microci (6) Therapeutic Radiopharmaceutical Other Than (5)

Remarks:

b. How many written directives, as applicable, did not contain the following required information l

[35.2]: Misses S.W.SW l i (1) Teletherapy (total dose, dose per fraction, treatment site, and overall treatment period)

(2) Gamma Stereotactic Radiosurgery (target  ;

' coordinates, collimator size, plug pattern, l and to.al dose '

,' (3) High-Dose-Rate Remote Afterloading Brachytherapy (radioisotope, treatment site,  !

and total dose)

(4) All Other Brachytherapy:

(a) Prior to implantation (radioisotope, number of sources, and source strengths)

APld (b) After implantation, but prior to completion of procedure .

(radioisotope, treatment site, and i

total source strength and exposure time (or, total dose)

(5) Na! I-125 or I-131 >30 microci (dosage)

(6) Therapeutic Radiopharmaceutical Other Than (5) - (radiopharmaceutical, dosage, and 4

route of administration)

Remarks:

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c. Are exceptions to written directives  !

documented (footnote to 35.32(a)(1)): Misses S.W.SW  !

(1) Written revisions (2) Oral revisions Y N (3) Oral directives Y N  ;

Remarks:

OBJECTIVE 2 l

a. Prior to each administration, does the licensee '

use more than one method to verify the patient's l identity as the individual named in the written l directive [35.32(a)(2)]: Misses S.W.F (1) Teletherapy (2) Gamma Stereotactic Radiosurgery (3) High-Dose-Rate Remote Afterloading Brachytherapy (4) All Other Brachytherapy (5) Nal I-125 or I-131 >30 microci (6) Therapeutic Radiopharmaceutical Other Than (5)

Remarks:

OBJECTIVE 3

a. Does the licensee implement procedures for verifying that the final plans of treatment and related calculations are in accordance with the respective written directives [35.32(a)(3)]:

(1) Teletherapy Y N (SW)

(2) Gaisna Stereotactic Radiosurgery Y N (SW)

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y N (SW)

(4) All Other Brachytherapy Y N (SW)

Remarks:

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b. Does the licensee implement' procedures for performing a check of dose calculations (i.e., computer-generated

' dose calculations and/or manual dose calculations)

[35.32(a)(3)]:

(1) Teletherapy Y N (W)

(2) Gamma Stereotactic Radiosurgery Y N (W)

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y N (W)

, (4) All Other Brachytherapy Y N (W) l Remarks:

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c. Has the licensee implemented procedures for I

performing acceptance testing (based on licensee's specific needs and applications) on each treatment

, planning or dose calculating computer program that l could be used for dose calculations [35.32(a)(3)]: i (1) Teletherapy Y N (W)  !

(2) Gamma Stereotactic Radiosurgery Y N (W)

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y- N (W)

(4) All Other Brachytherapy Y N (W) 1

{ Remarks:

i< OBJECTIVE 4

. a. Does the licensee implement procedures to verify, l before administering each radiation dose or radiopharmaceutical dosage, that the specific details of the administration are in accordance with the j written directive [35.32(a)(4)]:

1 l (1) Teletherapy Y N (SW)

(2) Gamma. Stereotactic Radiosurgery Y N (SW)

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y N (SW)

(4) All Other Brachytherapy Y N (SW)

(5) NaI I-125 or I-131 >30 microci Y N (SW)

(6) Therapeutic Radiopharmaceutical Other Than (5) Y N (SW)

. Remarks

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OBJECTIVE 5

a. Does the licensee implement procedures to identify and evaluate any unintended deviations (e.g.,

mistakes, errors, or omissions) from the written directive [35.32(a)(5)]:

(1) Teletherapy Y N (SW)

(2) Gamma Stereotactic Radiosurgery Y N (SW)

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y N (SW)

-(4) All Other Brachytherapy Y N (SW)-

(5) Na! I-125 or I-131 >30 microci Y N (SW)

(6) Therapeutic Radiopharmaceutical Other Than (5) Y N (SW)

Remarks:

(a)(1) Briefly describe the licensee's monitoring and evaluation process used to identify unintended deviations (e.g., errors, mistakes, or omissions) from the written directive:

(i) Teletherapy (ii) Gamma Stereotactic Radiosurgery (iii) High-Dose-Rate Remote Afterloading Brachytherapy ,

(iv) All Other Brachytherapy (v) Nal I-125 or I-131 >30 microci (vi) Therapeutic Radiopharmaceutical Other Than (v) .

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b. Dio the licensee identify and evaluate any unintended deviations (e.g., mistakes, errors, or omissions) from the written directive since l

the last inspection [35.32(a)(5)]:

l (1) Teletherapy Y N l (2) Gamma Stereotactic Radiosurgery Y N 1 (3) High-Dose-Rate Remote Afterloading Crachytherapy Y N i (4) All Other Brachytherapy Y N (5) Na! I-125 or I-131 >30 microci Y N (6) Therapeutic Radiopharmaceutical Other Than (5) Y N Remarks:

c. Describe any unintended deviations from the written directive, identified by yourself, that occurred even though the policies / procedures in the licensee's QM program were followed [35.32(a)(5)]:

(1) Teletherapy (2) Gamma Stereotactic Radiosurgery (3) High-Dose-Rate Remote Afterloading Brachytherapy (4) All Other Brachytherapy (5) NaI I-125 or I-131 >30 microci (6) Therapeutic Radiopharmaceutical Other Than (5)

d. Does the licensee implement procedures to ensure appropriate (corrective) action is taken after any unintended deviations from the written directive are identified and evaluated [35.32(a)(5)]:

(1) Teletherapy Y N (W)

(2) Gamma Stereotactic Radiosurgery Y N (W)

(3) High-Dose-Rate Remote Afterloading Brachytherapy Y N (W)

(4) All Other Brachytherapy Y N (W)

(5) Nal I-125 or I-131 >30 microci Y N (W)

(6) Therapeutic Radiopharmaceutical Other Than (5) Y N (W)

Remarks:

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7. BECORDABLE EVENTS AND MISADMINISTRATIONS i

a. Did the licensee identify any recordable events- '

since the last inspection [35.32(c) and 35.2]: Y N  !

I Remarks:

b. Does the licensee implement procedures to evaluate '

and respond to each recordable event within 30 days  !

after discovery [35.32(c)]: Y N j (1) Assemble relevant facts including the cause, -Y N And  ;

(2) Identify corrective action to prevent recurrence, Y N '

and ,

(3) Retain a record of (1) and (2)

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Y N Remarks:

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c. Were any recordable events. identified by yourself i that the licensee failed to identify [35.32(c)  ;

and 35.2]: ,

(1) Teletherapy Y (W) N (2) Gamma Stereotactic Radiosurgery Y (W) N (3) High-Dose-Rate Remote Afterloading Brachytherapy Y (W) N (4) All Other Brachytherapy Y (W) N .

(5) Na! I-125 or I-131 >30 microci Y (W) N l (6) Therapeutic Radiopharmaceutical Other Than (5) Y (W) N  !

Remarks:

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d. Did the licensee report any misadministrations since the last inspection [35.33(a)]

Y N If "Yes," answer the following:

I (1) Did licensee notify NRC within next calendar day after discovery [35.33(a)(1)], Y N Ed (2) Submit written report to NRC within 15 days

after discovery [35.33(a)(2)], Y N

! And (3) Notify referring physician and patient

• within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery [35.33(a)(3)] Y N

• Note: Referring physician may choose to personally inform the patient in lieu of Itcensee notification, or not inform the patient based on medical judgement Remarks:

2. If patient was notified, did licensee furnish written report to patient within 15 days after discovery of misadministration [35.33(a)(4)]: Y N Remarks:

I

f. Recorc of each misadministration maintained by licensee, including actions to prevent recurrence [35.33(b)]: Y N l

Remarks: i

g. Did the licensee identify any misadministrations that were not subsequently reported [35.33(a)]: Y(SF) N If "Yes," briefly describe the reasons given by the  !

RSO, supervising authorized user, and any other involved individuals for not reporting ,

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h. Were any misadministrations identified oy yourself i that the licensee failed to identify [35.2 9nd 35.33):

(1) Teletherapy I Y (SF) N .

(2) Gamma Stereotactic Radiosurgery Y (SF) N (3) High-Dose-Rate Remote Afterloading Brachytherapy Y (SF) N  ;

(4) All Other Brachytherapy Y (SF) N 1 (5) NaI I-125 or I-131 >30 microci . Y (SF) N ,

(6) Therapeutic Radiopharmaceutical Other Than (5) Y (SF) N )

Remarks:

1 4

8. RECORDS 4

[ Note - Under each modality for Section 8, I miss is considered as I

" Satisfactory (S)", 2 misses indicates a " Weakness-(W)", and 3 or more misses indicates a " Failure (F)"] l L

a. How many times did the licensee prepare a written l directive, but failed to maintain a record for  ;

the following administrations [35.32(d)(1)]: Misses 1.M E  ;

(1) Teletherapy  :

(2) Gamma Stereotactic Radiosurgery  !

(3) High-Dose-Rate Remote Afterloading )

Brachytherapy (4) All Other Brachytherapy i I

(5) Nal I-125 or I-131 >30 microci (6) Therapeutic Radiopharmaceutical Other Than (5) .

Remarks: J i

b. How many times did the licensee fail to retain a i record of each administered radiation dose or radiopharmaceutical dosage for the following administrations [35.32(d)(2)]: Misses S.W.F (1) Teletherapy (2) Gamma Stereotactic Radiosurgery

_ (3) High-Dose-Rate Remote Afterloading Brachytherapy (4) All Other Brachytherapy (5) NaI I-125 or I-131 >30 microci (6) Therapeutic Radiopharmaceutical Other Than (5)

Remarks:

10

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9. PERIODIC REVIEWS

a. How many times did the licensee fail to conduct a review of the QM program at intervals no greater than 12 months [35.32(b)(1)]:

b. When was the last review performed:

Date

c. Did the review include each applicable program area [35.32(b)(1)]:

(1) Teletherapy Y N

. (2) Gamma Stereotactic Radiosurgery Y N i (3) High-Dose-Rate Remote Afterloading Brachytherapy Y N

, (4) All Other Brachytherapy Y N (5) Nal I-125 or I-131 >30 microci Y N (6) Therapeutic Radiopharmaceutical Other Than (5) Y N Remarks:

d. Did the licensee evaluate each review to determine the effectiveness of the QM program [35.32(b)(2)]: Y N If "No," describe the reasons given by the RSO, supervising authorized user, and other responsible individuals for the failure to evaluate each review

e. Based on the evaluation of each review, did the licensee, if required, make modifications to meet  :

Objectives 1 - 5 in Section 6 (35.32(b)(2)]: Y N l If "Yes," briefly describe the modifications If "No," describe the reasons given by the RSO, supervising authorized user, and other responsible individuals for the failure to make necessary modifications

f. Did the licensee retain records of each review, including the evaluation and findings i

[35.32(b)(3)]: Y N l 1

If "No," describe the reasons given by the RSO, supervising authorized user, and other i responsible individuals for the failure to i

retain a record '

11

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g. Did the review include, for each applicable program -

area, an evaluation of the following:  !

i (1) A representative sample of patient  :

administrations [35.32(b)(1)] Y N i And (2) All recordable events [35.32(b)(ii)] Y N i AD4 ,

(3) All misadministrations [35.32(b)(111)] Y N  !

If "No," describe the reasons given by the RSO, j supervising authorized user, and other '

responsible individuals for the failure to  :

include an evaluation of (1) - (3) i

10. MODIFICATIONS l

a. Did the licensee choose to make modifications to the QM program to increase the program's efficiency (provided effectiveness not decreased)

[35.32(e)]: Y N

• If "Yes," were the modifications furnished to .

the NRC within 30 days after modification was i made [35.32(e)]: Y N i i

If "No," describe the reasons given by the RSO, [

supervising authorized user, and other j responsible individuals for the failure to  :

furnish the modification  !

11. RESULTS OF REVIEW

a. Briefly describe the overall implementation of the QM Program and summarize the inspection <

findings:

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t APPENDIX i

1. TARGET SAMPLE l

Use Table I to determine approximately how many administrations to sample and review (target sample) for each modality listed (e.g.,

Nal 1-125 or I-131 >30 microCi) in Section 6: Objective 1.a - c, and Section 8.a - b of the Interim Field Notes. Record this information in Section 5.a.

Table I E IllE Total Taraet Adlainistrations Are Samole is 1 to 10 All 11 to 100 10

>100 10%

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4 APPENDIX

2. FURTHER SAMPLING Use Table II to determine approximately how many more administrations to sample and review (new target sample) for each modality listed in Section 6: Objective 1.a - c, and Section 8.a - b of the Interim Field Notes j_f two or more misses

• are identified in the target sample (Table I). Record this information in Section 5.a.

Table II IE AREl IHE Totg1 Triocer N_g Administrations Are Level Is Taroet Samole Is 1 to 50 2 or > misses All 51 to 100 2 or > misses 50

>100 2 or > misses 50%

• Misses are defined as omissions or failures to meet specific requirements in the objective.

I G:\ FIELD.F ,

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Attachment 2 l l

1

october 1991 neug U.S. NUCLEAR REGULATORY COMMISSION ,

a REGULATORY GUIDE

(*****)s OFFICE OF NUCLEAR REGUI.ATORY RESEARCH REGULATORY GUIDE 8.33 (Task DG-8001)

QUALITY MANAGEMENT PROGRAM I

l USNRC REGUIATORY GUIDES The guides are issued in the folicwing ten troad dMsions:

Regulatory A N are lesund to descrtbo and make avaltable to the pido-

1. Power Reactors 6. Prockets the Commiselon lans, to try 1 7. Transportation

2. Research and Test Reactors staff an evaluating spacette protnoms o.* postulated acx:6 dents, or to pro. 3. Fuels and Materiale Facillt6es 8. Occipatlanal Healtn vtan gu6 dance to applicants. Regulatory Guidos are not enestitutes for '

..->tal and Stting g. Antitrust and Financial Review i

j

,^- regulations, and compl6ance wttn them is not respJired. Methods and 8S.En'terials Ma and Plant Protection 10. General solutions different from those est out in the paldes wHi be acceptable if s

V anos by , ,

Offke at the current GPO prios intormation on current GPO prices may This guide was issued after consideration of comments received from be obtained by contacting the Siperintendent of Documents, U.S. Gov.

l

- the pihitc. Comments and suggest6ons for improvements in those amment Printing Offlee, Post Office Bon 37082. Washington, DC EN6 des are anoouraged at all times, and guldee will be revtead, as ap- 20013-7082, telephone (202)275,2000 or (2G2)275-2171.

propriate, to accommodate corrments and to rehect row enformation or e ensnartence.

Wrttten comments rnay be submitted to the Regulatory Publications issued guides may also be purchased from the National Tectriical infor-

! motion Serv 6ce an a et orear beels. DeteHs on thss service may to

' Branch, DFPS, ARM, U.S. f'Actear Regulatory Commission. Washing- obtained bt writing NTIS, Port Royal Road. Springf6eid, VA 22161.

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TABLE OF CONTENTS 1

1 Page l A. IhTFQ DUCTI ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-1' B. DIS C U S SION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-1 C. REG ULATORY POSITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-1

1. Suggested Policies and Procedures for Certain BarHnpharma'wwwal Uges , , , , , , , , , , , , , , 8,33-1  ;

2. Suggested Policies and Procedures for Teletherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-2

3. Suggested Policies and Procedures for Brachytherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-4 3.1 High-Dose-Rate Remote Afterloading Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-4 3.2 All Other Brachytherapy Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-5

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4. Suggested Policies and Procedures for Gamma Stereotactic Radiosurgery . . . . . . . . . . . . . . . 8.33-6

5. Oral Directives and Revisions to Wr'itten Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-7

6. Periodic Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-7 D. I M PLEMENTATI ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-8 B IB L I OG RA PHY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.33-9 REGULATORY AN ALYSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.3 3-10 l

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i A. INTRODUCTION e Procedures to confirm that, prior to adminiera- ,

tion, the person responsible for the treatment  !

3

! u AwwC.g to 5 35.32. "Quahty Management Pro- modahty will check the specific details of the ,

gram." of 10 CFR Part 35, " Medical Use of written directive (e.g., in radiopharmaceutical i l Byproduct Material," applicants or licensees, as appli- therapy, verify the radiopharmaceutical, dosage, ,

cable, are required to establish a quahty management and route of administration; or in oncology, ver- )

(QM) program. his regulatory guide provides guid- ify the treatment site, total dose, dose per frac- l ance to heensees and applicants for developing poli- . tion, and overall treatment penod),

j cies and procedures for the QM program. His guide e ProcMures o remrd tb ra&opharman =='ds =1 j does not restrict or limit the licensee from using other dosage or radiation dose actually administered.

j guidance that may be equally useful in developing a QM program, e.g., information available from the

, C. REGULATORY POSITION Joint r'ammiania's on Accreditation of Heakhcare

Organizations or the American College of Radiology. His regulatory guide provides guidance to licen-l sees and ayyL,44. for developing a quahty manage-i Any information collection activities mentioned ment program acceptable to the NRC staff for comply-

[ in this regulatory guide are contained as requirements ing with 10 CFR 35.32. However, a licensee or l in 10.CFR Part 35, which provides the regulatory basis applicant may use other sources of guidance and

for this. guide, ne information collection require- experience in addition to or in lieu of this regulatory j ments in 10 CFR Part 35 have been cleared under guide. The NRC staff would review such a program on j OMB Clearance No. 3150-0010, a case-by-case basis.

5 B. DISCUSSION The licensee's.QM progr&m should contain then

essential elements of the policies and procedures listed 1 The admmistration of byproduct material can be a in the following sections.

l

complex process for many types of diagnostic and i therapeutic procedures in nuclear m

dicine or oncol. 1. SUGGESTED POLICIES AND

ogy departments. A number of individuals may be PROCEDURES FOR CERTAIN l involved in the dehvery process. For example, in an RADIOPHARMACEUTICAL,USES i

oncology department when the authorized user pre- 1.1. De licensee should establish a pohcy to senbes a teletherapy treatment, the delivery process have an authonzed user date anii sign a wntten

{ may involve a team of medical professionals such as a radiation therapy physicist. dosimetrist, and radiation h of g W g, ,,,g,,,,, og therapy technologist. Conductmg the plan of treat- 30 deroch of & =adna .

ment may myolve a number of measurements, calcula- iodide I-125 or I-131. A written directive is required l tions, computer-generated treatment plans, patient 1

sunulations, portal film ven6 cations, and beam- M CPR 43W$ h h W h l

modifymg devices to dehver the prescribed dose. W to w& ten h am contained in.

Therefore, instrucuons must be clearly communicated Regulatory Mn 5.

l to the professional team members with constant atten- 1.2. Before Mmuustamg a raw=ade =1 tion devoted to detail dunng the treatment process. dosage, the bcensee should a=rahhsh a procedure to l

Complicated processes of this nature require smd verify by more than one method the identity of tly

! planrung and clear, understandable procedures. patient as the individual named in tha written direc-

! tive. Identifymg the patient by more than one method i he admirustration of byproduct material or radia* is required by 10 CFR 35.32(a)(2). He procedure 3

tion from byproduct matenal can involve a number of used to idaneity the patient shanid be to ask the

! treatment modalities, e.g., radiopharmaceutical ther- p.s name aM confirm the name and at least one

apy, teletherapy, brachytherapy, or gamma stereotac- of the fatW by comparison with correspondag j tic adiosurgery. For each modality, this regulatory information in the patient's record

birth date, ad-5 gwde recommends specific policies or procedures to dress, socW securay nn=har, signature, the name on j ensure that the objectives of 10 CFR 35.32 are met. th patima's ID bracelet or Wal ID card, or the j -In general, this guide recommends that licensees have: name on the patient's snedical insurance card.

$ e Pohcies to have an authorized user date and sign 1.3. He licensee should establish a procedure a written directive prior to the admirustration,' to venfy, before administenna the byproduct mate-

! A e Procedures to identify the patient by more than rial, that the specific details of the admirustration are j

me snethod, h ah we h h Mm Tk rMio-l phar a_===de =1- dosage, and route of administration

e Procedures to be sure the plans of treatment are should be confirmed by the person admhustering the j in accordance with the written directive, radnapharmaceutical to verify agreement with the writ-i

t j ten directive, that is, the dosage should be measured of treatment may be obtained from 6e American .... !

in the dose calibrator and the resuhs compared with College of Radiology. '

the prescribed dosage in the written directive.

2.4. The licensee should establish a procedure  !

1.4. N licensee should establish a policy for all to verify,'before administering each teletherapy dose, ,

workers to seek guidance if they do not understand that the specinc details of the admmistration are in #

how to carry out the written directive. That is, workers accad.i.cc with the written directive and plan of  ;

ahandd ask 18t5 have any quaalana about what to do treatment. In,particular, the treatment site and the or how it @, W Se' done rather than contmuing a dose per fraction should be confirmed by the person  :

~

procedure su c c. e is any doubt. administering the teletherapy treatment to verify agreement with the written directive and plan of 1.5. h sican==* should establish a procedure treatment.

to have an authonsed user or a qualified person under the supervision of an authonsed user (e.g., a 2.5. The licensee should establish a policy for all nuclear madne=* physician,. physicist, or technolo- workers to seek guidance if they do not understand sist), after administenna a radiopharmaceutical, how to carry out the written directive. That is, workers l make, date, and sign or initial a written record that should ask if they have any questions about what to do '

documents the administered dosage in the patient's or how it should be done rather than continuing a chart or other appropriate record. The responsibilities Procedure when there is any doubt.

and conditions of supervision are contained in 10 CFR 35.25. A record of the administered dosage is re- 2.6. 'Ihe licensee should establish a procedure quired by 10 CFR 35.32(d)(2). to have a quahfied person under the supervision of an ,

authorized user (e.g., an oncology physician, radiation 1.6. 'Ihe licensee should establish procedures to thempy physicist, dasimatrist, or radiation therapy echnologist), aher adrninistering a telethenpy dose perform periodic reviews of the radiopharmaceutical fract on, ana e, date, and sign a midal a written QM program. Guidance on periodic reviews is pro-record in the patient s chart or in another appropriate vided in Regulatory Position 6. A QM program review record that contains, for each treatment field, the is required by 10 CFR 35.32(b). treatment time, dose adminnarered, and the cumula-tive dose administered. 'Ibe responsibilities and condi-

2. SUGGESTED POLICIES AND tions of supervision are contained in 10 CFR 35.25. A PROCEDURES FOR TELETHERAPY record of the admmistered dose is required by 10 CFR 2.1. h licensee should establish a policy to have an authonzed user date and sign a written 2.7. The licensee should estabhsh a procedure directive prior to the adsninimeration of any telethemPY to have a weekly' chart check performed by a quahfied dose. A written directive is required by 10 CFR person under the supervision of an authorized user 35.32(a)(1). Procedures for oral directives and revi- (e.g., a radiation therapy physicist, dosunetrist, oncol- 2 sions to written directives are contamed in Regulatmy ogy physician, or radiation therapy technologist) to l Position 5. detect mistakas (e.g., arithmetic errors, miscalcula-tions, or incmi.ct transfer of data) that may have  !

2.2. Before adminiararms a teletherapy dose, occurred in the daily and cumulative teletherapy dose i the licensee should establish a procedure to verify by adminierrations from all treatment fields or in connec-more than one method the identity of the patient as tion with any changes in the written directive or plan the individual named in the written directive. Identify- of treatment. 'Ihe responsibilities and conditions of ing the patient by more than one method is required supervision are contained in 10 CPR 35.25.

by 10 CPR 35.32(a)(2). The procedure used to (dantify the patient should be to ask the patient's 2.g. If the prescribed dose is to be administered name and confirm the name and at least one of the in more than three fmetions, the licensee should l fonowing by comparison with the corresponding infor- estabbsh a procedure to check the dose calculations niation in the patient's record: birth date, address, within thresi working days after admirustering the first social security number, signature, the name on the teletherapy fractional dose. An authonzed user or a patient's ID bracelet or hospital ID card, the name on quahfind person under the supervinon of an author-the patient's madical insurance card, or the photo- Ized user (e.g., a radiation therapy physicist, oncology graph of the patient's face. physician, dasimetrist, or radiation therapy technolo-gist), who whenever possible did not make the original 2.3. h bconsee should establish a policy to calculations, should check the dose calculations. If the have an authorised user approve a plan of treatment . prescribed dose is to be admirustered in three frac-that provides aufnciant information and direction to tions or less, a procedure for checking dose calcula-meet the objectives of the written directive. Suggested tions as described in this paragraph should be per-guidehnes for information to be included in the plan formed before administering the first teletherapy 8.33-2

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l l fractional dose. De responsibilities and conditions of (2) A teletherapy physicist (or an oncology supervision are contained in 10 CFR 35.32. physician, damimatrist, or radiation therapy *erhaala-

. gist who has been propedy instnicted) using a ther-

Manual dose calculations should be checked for

mah>=inascanca damimarry service available by mail

that is designed for c=~ N ^ ' =.py doses and (1) Arith ==+ie errors, that is accurate within 5 percent.

! (2) Appropriate transfer of data from the writ- 3.10. he heanmaa should antahhah a pisstw

ten directive, plan of treatment, tables, and graphs, to have full calibrataan measurements (required by 10 ,

CPR 35.632) include the determinarian of transmis- l l (3) Appropnate use of nomograms (when'ap- sion factors for trays and wedges. Trenamismian factors l plicable), and for other beam-modifymg devices (e.g., nonracmat=hla j i blocks, recastable block material, bolus and compen- j (4) Appropnate use of all pertinent data in the

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1 sator matenals, and split-beam blocking devices) j calculations. should be determined before the first medical use of the beam-siic&fi g device and after repla:ement of I Computer-generated dose calculations should be the source.

I checked by examuung the computer pnntout to verify that the , correct data for the patient were used in the 2.11. De licensee should establish a procedure

calculations (e.g., patient contour, patient thickness at to have a physical measurement of the teletherapy j the central ray, depth of target, depth dose factors, output made under applicable conditions prior to l treatment distance, portal arrangement, field sizes, or admimstration of the first teletherapy fractional dose if

- beam-modifymg factors). Alternatively, the dose the patient's plan of treatment inchwies (1) field sizes .

l should be manually calculated to a smgle key point or treatment distances that fall outside the range of j and the resuhs compared to the computer-generated those mamanred in the most recent full calibration or dose calculations. (2) transmianian factors for beam-iissGI,; g devices

(except nonrecastable and recastable blocks, bolus j __

If the manual dose calculations are performed and compensator materials, and split-beam blocking

using computer-generated outputs or vice versa, par- devices) not measured in the most recent full calibra-i ticular emphans should be placed on verifymg the tion measurement. . .

!. correct output from one type of dose calculation (e.g.,

! computer) to be used as an input in another type of '2.12. If the authorized user ddterames that de-I dose calculataan (e.g., manual). Parameters such as laying treatment to perform the checks of (1) dose

the transmin=on factors for wedges and the source entenistiana for a prescribed dose that is administered

! strength of the sealed source used in the dose calcula- in three fraetions or less (see Regulatory Position 2.8) ,

j tions should be checked. or (2) telatherapy output (see Regulatory Pnsitinri l 2.11) woukyoopardise the patient's heakh because of 1 2.9. %e beensee should establish a procedure the emergent nature of the patient's medical condi . ,

j for independently checking certain full calibration tion, the prescribed treatment may be provided with-measurements as follows out first performing the checks of does calculations or l ,

physical measurements. De mishnrised user should

! After full cahbrauon measurements that resuked make a notation of this determinarian in the records

' from replacement of the source, or whenever spot- of the calculated adminierared does. De checks of check measurements indicate that the output differs the calculations should be performed within two work-

by more than 5 percent from the output obtained at ing days of completion of the treatment.

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. the last full calibration corrected mathematically for j radioactive decay, an independent check of the out- 2.13. De hcensee should establish a procedure i put for a single speciSed set of exposure condelane for performing acceptance testing by a quahfied i should be perfonned. %e independent check should person (e.g., a teletherapy physicist) on each treat-

! be performed within 30 days folkswing such full cali- ment planning or dose.e=lentating computer program

. bration measurements. that could be used for ^

• t- .yy dose emiculatiana.

j Acceptance testing should be perfbrmed before the j %e independent check should be performed by first use of a tramtmant planning or dose calculating i either: ea==*er program for teletherapy dose calculations.

j .

Accaaranca testing should'Also be performed after full

, m (1) An incJvidual who did not perform the full calibration mamanrements when.the calibration was 4 ,

calibration (the inhtual should meet the require- performed (1) before the first madical use of the

} V ments specified in 10 CMt 35.961) using a dammatry teletherapy unit, (2) after j .- = of the source,

system other than the one that was used dunng the full or (3) when spot check measurements indicated that a calibration (the dosametry system should meet the the output differed by more than 5 percent from the

! requirements specified in 10 CFR 35.630(a)), or output obtained at the last full calibration corrected i

i a== =

mathematically for radioactive decay. Computer- or how it should be done rather than continuing a -,

generated beam data should be compared to meas- procedure when there is any doubt.

ured beam data from the teletherapy unit. The licen- l see should assess each treatment planning or dose 3.1.5. ne licensee should establish a proce- j calculating computer program band on the licensee's dure for using radiographs or other comparable images specific needs and applications. (e.g., computerized tomography) as the basis for verifymg the position of the nonradioactive " dummy" 2.14 he licensee should establish procedures to sources - and calculating the adminia-red perform periodic reviews of the teletherapy QM brachytherapy dose before inserting the sealed program. Guidance on periodic reviews is provided in sources.

• Regulatory Position 6. A QM program review is re-quired by 10 CFR 35.32(b). 3.1.6. The licensee should establish a proce-dure to check the dose calculations before administer-

3. SUGGESTED POLICIES AND ing the prescribed brachytherapy dose. An authorized PROCEDURES FOR BRACHYTHERAPY user or a qa=Wiad person under the supervision of an authorized user (e.g., a radiation therapy physicist, 3.1 High-Dose-Rate Remote Afterloading Devices oncology physician, dosunetnst, or radiation therapy technologist), who whenever possible did not make Simdar licensee policies and procedures for low. the original calculations, should check the dose calcu-and medium-dose-rate remote afterloading devices lations. The responsibihties and conditions of " super-would be equally helpful. vision" are contained in 10 CFR 35.25. Suggested methods for checking the calculations include the -

3.1.1. He licensee should establish a policy to following: ,

have an authorized user date and sign a written directive prior to the adaurustration of any

• Computer-generated dose calculations should be brachytherapy dose from a high-dose-rate remote checked by examming the computer printout to afterloading device. A written directive is required by . y that correct input data for the patient were used in the calculations (e.g., source strength and 10 CFR 35.32(a)(1). Procedures for oral directives and revisions to wrinen directives are contained in Positions).

Regulatory Position 5.

• He computer-generated dose calculations for in-put into the brachytherapy afterloading device 3.1.2. Before adaurustering a brachytherapy should be checked to verify correct transfer of treatment, the licensee should establish a procedure to data from the c==== (e.g., channel numbers, verify by more than one method the identity of the source posinons, and treatment times).

patient as the individual named in the written direc- 3.1.7. The licensee should establish a proce-uve. Identifying the patient by more than one method' dure to have an authorb.ed user, after administering is required by 10 CFR 35.32(a)(2). He procedure the brachytherapy treatment, date and sign or initial a used to identify the pauent should be to ask the written record of the calcidated administered dose in patient's name and conhrm the name and at least one the patient's chart or in ar.other appropnate record. A of the following by companson wah the corresponding record of the ad=iaie= red dose is required by 10 CFR information m the pauent's record: birth date, ad-35.32(d)(2).

dress, social security number, signature, the name on the patient's ID bracelet or hospital ID card, the name 3.1.8. If the authorized user determines that on the patient's medical insurance card, or the photo- delaying treatment in order to perform the checks of graph' of the patient's face. dose calculations (see Regulatory Position 3.1.6)

. would jeopardize the patient's heakh because of the 3.1.3. De licensee should establish a proce- emergent nature of the patient's madeal condition, dure to verify, before ad=iai=aring the brachytherapy. the checks of the calculations should be performed

. dose, that the specific details of the brachytherapy withm two working days of the treatment.

ad==leration are in accordance with the written '

directive and plan of treatment. The prescribed radio- ' 3.1.9. he licensee should establish a proce-isotope, treatment site, and total dose should be dure for performing acceptance testing by a qualified confirmed by the person adminie= ring the Person (e.g., a teletherapy physicist) on each treat-brachytherapy treatment to verify agreement with the ment planning or dose calculating computer program ,

wntten directive and plan of treatment. that could be used for brachytherapy dose calculations  !

when using high-dose-rate remote afterloading de-3.1.4. De licensee should establish a policy for vices. Acceptance testing should be performed before  ;

all workers to seek guadance if they do not understand the first use of a treatment planning or dose calculat- '

how to carry out the wntten directive. nat is, workers *g % m _ g% % g gg should ask if they have any questions about what to do sources 8.33-4

i-ing computer program for brachytherapy dose calcula- sources to be used are in agreement with the written

.m ; tions when using high-dose-rate remote afterloading directive and plan of treatment before implanting the j devices. The licensee should assess each treatment radioactive sealed sources.* The licensee may use any plannmg or dose calculating computer program based appropnate verifinnan method, such as checking the on the licensee's specific needs and applications. serial number of the sealed sources behind an appro-priate shield, using a radiation detector, using a dose 3.1.19. The hcensee should estabbsh proce* calibrator, using color-coded sealed sources, or using dures m perform is.h reviews of the bachythempy clearly marked storage locations, i.e., one location for OM progmm for using the high-dose-rate remote after- each source strength. The responsibilities and condi-loodmg device. Guidance on periodic reviews as peded tions of supervision are contained in 10 CFR 35.25, in Regulatory Positaon 6. A QM program review is re-l qmred by 10 CFR 35.32(b). 3.2.6. For temporary brachytherapy implants, the licensee should establish a procedure for using 3.2. All Other Brachytherapy Applications radiographs or other comparable images (e.g., com-l putenzed tomography) of brachytherapy radioactive 3.2.1. The licensee should establish a policy to sources or nonradioactive " dummy" sources in place l have an authorized user date and sign a written as the basis for venfymg the position of the sources i directive prior to the admmistration of any and calculating the exposure time (or, equivalently, brachytherapy dose. A written directive is required by the total dose). Whenever possible, nonradioactive 10 CFR 35.32(a)(1). Procedures for oral directives " dummy" sources should be used before inserting the and revisions to written directives are contained in radioactive sources (e.g., cesium-137 sealed sources Regulatory Position 5. .

used for intracavitary applications). However, some brachytherapy procedures may require the use of 3.2.2. Before administering a brachytherapy various fixed geometry applicators (e.g.. appliances or dose, the licensee should establish a procedure to templates) to establish the location of the, temporary verify by more than one method the identity of the sources and calculate the exposure time (or, equiv-patient as the individual named in the written direc- alently, the total dose) required to administer the tive. Identifying the patient by more than one method prescribed brachytherapy treatment. In these cases, is required by 10 CFR 35.32(a)(2). The procedure radiographs or other comparable images may not be used to identify the patient should be to ask the necessary provided the position of the sources is patient's name and confirm the name and at least one known prior to inserting the radioactive sources and of the following by comparison with the corresponding calculating the exposure time (or, equivalently, the information in the patient's record: birth date, ad- total dose).

dress, social security number, signature, the name on 3.2.7. For permanent brachytherapy implants, the patient s ID bracelet or hospital ID card, the name .ne licensee should establish a procedure for using on the patient s medical insurance card, or the photo- radiographs or other comparable images (e.g.,

graph of the patient s face. computerized tomography) of brachytherapy radioac-dve sources in place as the basis for verifying the-3.2.3. The licensee should establish a proce-Posnion of se seces and calculadng se total dose, dure to verify, before adnurustering the brachytherapy if APPlicable, after inserting the sources (e.g.,

dose, that the specific details of the brachytherapy no&ne425 sealed sources used for intentnial appuca-admmistration are in accordance with the written dons). Howmr. sorne brachyserapy pmcedums may directive and plan of treatment. In particular, the mquire se use of varims Exed gemetry appucaton radioisotope, number of sources, and source strengths (8 g , templ ates) to establish the location of the should be confirmed to verify agreement with the sources and calculate the total dose, if apphcable. In wntten directive and plan of treatment. these cases, radiographs or other comparable images 3.2.4. The license, should estabhsh a policy for may not be necessary.

all workers to see? quidance if they do not understand 3.2.8. After insertion of the temporary implant how to carry out w : wrnten directive. That is, workers brachytherapy sources (see - Regulatory Position should ask if they .e any questions about what to do 3.2.6), the licensee should establish a procedure to or how it should be done rather than continuing a have an authorized user promptly record the actual i procedure when there is any doubt. loading sequence of the radioactive sources implanted l (e.g., location of each sealed source in a tube, 3.2.5. The licensee should establish a proce- tandem, or cylinder) and' sign or initial the patient's j dure to have an authorized user or a quahfied person chart or other appropriate record.

under the supervision of an authorized user (e.g., a 3.2.9. After-insertion of the permanent implant radiation therapy physicist, oncology physician, brachytherapy smrces (see Regulatory Position

~.- dosametrist, or radiation therapy technologist) verify that the radioisotope, number of sources, source  % .rm .w saure Includes wires and encapsulated strengths, and, if applicable, loading sequence of the re .

8.33-5 ,

3.2.7), the licensee should establish a procedure to within two working days of completion of the have an authorized user promptly record the actual brachytherapy treatment.

number of radioactive sources implanted and sign or initial the patient's chart or other appropnate record. 3.2.13.*Ihe licensee should establish a proce- i dure for performing acWaaee testing by a qualified 3.2.10. "Ihe' licensee should establish a proce- person (e.g., a teletherapy physicist) on each treat-dure to check the dose calculations before the total ment planning or dose calculating computer program prescribed brachytherapy dose has been administered. that could be used for brachytherapy dose calcula-An authonzed user or a qualified person under the tions. Ace ===e* testing shanid be performed before supervision of an authorized user (e.g., a radiation the first use of a treatment planning or dose calculat-therapy physicist, oncology phyacian, damen*tnst, or ing computer program for brachytherapy dose calcula-radiation therapy technologist), who whenever. possi- tions. 'Ibe licensee should assess each treatment plan-ble did not make the original calculations, should ning or dose e=1-= =N e==aneer program based on ,

check the dose calculations. The responsibahties and the licensee's specific needs and applications. ,

conditions of supervision are contained in 10 CFR 3.2.14. The licensee should establish procedures 35.25. Manual dose calculations should be checked to perform periodic reviews of the brachytherapy QM i for: program. Guidance on periodic reviews is provided in Arithmetic errors, Regulatory Posinon 6. A QM program review is re-e quired by 10 CFR 35.32(b).

• Appropriate transfer of data from the written di-rective, plan of treatment, tables, and graphs, 4. SUGGESTED POLICIES AND PROCEDURES FOR GAMMA e Appropriate use of nomograms (when applica- STEREOTACTIC RADIOSURGERY ble), and e Appropriate use of all pertinent data in the calcu. 4.1. The licensee should establish a policy to lations.

have an authonzed user date and sign a written directive before ad=latee ing treatment. A written

~

Computer-generated dose calculau.ons should be directive is required by 10 CFR 35.32(a)(1). Proce-checked by examuung the computer printout to verify dures for oral directives and revisions to written that the correct data for the patient were used in the directives are contained in Regulatory Position 5.

calculations (e.g., position of the applicator or sealed sources, number of sources, total source strength, or 4.2. Before administering treatment, the licen-source loadmg sequence). Ahernatively, the see should establish a procedure.to venfy by more brachytherapy dose should be manually calculated to than one method the idenuty of the patient as the a single key pouu and the results compared to the individual named in the wntien directive. Identifying <

computer-generated dose calculations. If the manual the patient by more than one method is regtured by f dose calculanons are performed using computer- 10 CFR 35.32(a)(2). The procedure used to identify generated outputs (or vice versa), particular emphasis the patient should be to ask the patient's name and should be placed on vertfying the correct output from confirm the name and at least one of the following by one type of calculauon (e.g., computer) to be used as companson with the corresponding information in the an input in another type of calculation (e.g., manual). patient's record. birth date, address, social security number, signature, the name on the patient's ID 3.2.11. 'Ihe bcensee should establish a proce- bracelet or hospital ID card, the name on the patient's dure to have an authonzed user date and sign or initial medical insurance card, or the photograph of the a written record in the patient's chart or in another patient's face. .

. appropriate record after insertion of the brachytherapy sources but prior to completion of the 4.3. 'Ihe licensee should establish a procedure procedure. The wntten record should include the to have the neurosurgeon, the oncology physician, radiossatope, treatment site, and total source strength and the radiation therapy, physicist date and sign a and exposure time (or, equivalently, the total dose). plan of tra'me=*nt that includes, for each tarsdt point.

A record of the admuustered dose (or, equivalently, the ceviCates, the plug pattem, the cammator size, the total source strength and exposure time) is re- the exposuse time, the target dose, and the total dose quired by 10 CFR 35.32(d)(2). before adminwering treatment.

4.4. 'Ihe licensee should establish a policy for all 3.2.12. If the authonzed user determines that delaying treatment in order to perform the checks of workers to seek guidance if they do not understand dose calculations (see Regulatory Position 3.2.10) how to carry out the written directive. That is, workers would jeopardize the patient's heakh because of the should ask if they have any questions about what to do emergent nature of the patient's medical condition, or how it should be done rather than continuing a the checks of the calculations should be performed procedure when there is any doubt.

e tu _,

i i

i 4.5. De licensee should establish a procedure 5. ORAL DIRECTIVES AND REVISIONS TO l ,3 to verify, before administering each treatment, that WRTITEN DIRECTIVES i "j the specific details of the administranon are in accor-dance with the wrnten directive and plan of treatment. A footnote to 10 CFR 35.32(a)(1) reads as fol-he venfication should be performed by at.least one lows:. '

j quahfied person (e.g., an oncology physician, radia-

"If, because of the patient's medical condi-

tion therapy physicist, or radiation therapy tachnala.

' tion, a delay in order to provide a written revision .

gist) other than the individuals who dated and signed

~ to an exasting wntten directive would jeopardize

! the wntten directive and plan of treatment. Particular i emphasis should be directed toward venfying that the the panent's heakh, an oral revision to an exisung

' stereotactic frame coordinates on the patient's skull written directive will be acceptable, provided that the oral revision is den =aantad i==adia'aly in the match those of the plan of treatment.

j pauent's record and a revised written direcove is dated and signed by the authorized user wahm 48 4.6. He licensee should establish a procedur* hours of the oral reymon.

! to check computer-generated dose calculations by

exammmg the computer printout to verify that correct "Also, a written revision to an existmg written data for the patient were used in the calculations. chrective may be made for any diagnosuc or therapeutic procedure provided that the revision is dated and signed by an authonzed user prior to

! 4.7. The licensee should establish a procedure se adsninistrau,on of se radiophannaceutical i to check that the computer-generated dose calcula- dosage, the brachytherapy dose, the gamma i tions were correctly input to the gamma stereotactic stereotactic radiosurgery dose, the teletherapy i radiosurgery unit. dose, or the next teletherapy fractional dose.

?

! "If, because of the emergent nature of the 4.8. ne licensee sha.dd establish a procedure l Patient's medical condition, a delay in order to j to have the neurosurgeon or the oncology physician,

after adnurustering the treatment, date and sign or Provide a wntten directive would jeopardize the initial a wntten record of the calculated administered patient's health, an oral directive will be accept-j dose in the patient's chart or in another appropriate able, provided that the information =*daad in i

record. A record of the administered dose is required the oral directive is documented immadia'dy in l " the patient's record and a written directive is f by 10 CFR 35.32(d)(2).

prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive."

4.9. If the authorized user determines that de- 6. PERIODIC REVIEWS laying treatment in order to perform the checks of the dose calculations (see Regulatory Positions 4.6 and The licensee should establish wntten procedures l to conduct periodic reviews of.each appbcable pro-j 4.7) would jeopardize the, patient's heahh be.ause of the emergent nature of the patient's medicsl condi- gram area, e.g., radioph ==- '=1=

- taletherapy, -

j

- tion, the checks of the caliutations abe.ad be per- brachytherapy, an'd samma stereotactic radnosurgery.

formed within two working days of N treatment. De review should include, from the previous 12 manths (or since the last review), a representative sample of patient admmW. au recontable 4.10. ne licensee should establish a procedure ennts, and aH anisahdons. He =* d -

i for performing acceptance testing by a qualified Pa,tient cases to be sampled slwuld be based on se i person (e.g., a teletherapy physicist) on each treat. Pnnciples d statisdcal =Wawa samphng and j ment planning or dose calculating ca=~ar program should represent each treatinent madamy perfonned that could be used for gamma stereotactic radiosur- in se insbunaon, e.g., 9--

r._mucal, i .

gery dose calculations. Acceptance testing should be teletherapy, brachytherapy, and gamma stereotactic l performed before the first use of a treatment planning radiosurgery. For avampla, using the acceptance sam-

or dose calculating computer program for gamma Pling tables of 10 CFR 32.110 and r 5 an error l stereotactic radiosurgery dose calmlations. He licen. rate (or la tolerance percent defective) d 2 percent, i see should assess each treatment planning or dose the number of patient cases to be reviewed (e.g.,115)

I calculating computer program based on the licensee's based on 1000 patients treated would be larger than specific needs and applications. the number of patient cases to be reviewed (e.g., 85) i based on 200 patients treated. In order to eliminate i i any bias in the sample, the patient cases to be

4.11. The licensee should establish procedures to perform periodic reviews of the gamma stereotactic reviewed should be selected randomly. For each pa- l 3

radiosurgery QM program. Ouidance on periodic re- tient's case, a comparison should be made between ,

views is provided in Regulatory Position 6. A QM what was adnunistered versus what was prescribed in l 3

j program review is required by 10 CFR 35.32(b). the written directive. If the kiifference between what i

i 8.33-7

. I I

1 1 was adminimared and what was prescribed exceeds the e For gamma stereotactic radiosurgery: target co- .l crheria for ekher a recordable event or a minedmin- ordinates, colliraator size, plug pattern, and total '

istredon, that comparison is unacceptable. The nurn dose. t bor of "imaccagwaNa compansons" that is allowed f - ~ For oaph patient case reviewed the licensee  !

each sample size and not tolerance percent defective is should idend deviations from the wntten directive,  ;

provided in the see-mane

• sampling tables of 10 CPR the cause of each devianon, and the acdon required i 32.110. to prevent recurrence. The actions may include new or revised pouies, new or revised procedures, addi-  ;

h M & could k conducted ta training, w increased supe % rehw d weekly, monthly, or quarterly if one of these periods is

• more campatihte with the lican=am's operations.

he licensee should reevaluate the OM program's j If fananda, the persons eaaA=da- the review policies and procedures after each annual myiew to i should not review their own work. If this is not determine whether the program is still effective or to l poulbie, two people should wak meetbr as a team to identify actions reqmred to make the program more )

conduct the review of that work. ne hcensee or effective. 1 designee should regularly review the findings of the riodi reviews to ensure that the QM program is Program review resuhs should be documented and should be available for NRC inspectors. To obtain the msnmnm resuhs from the lessons learned from each  ;

For each patient case reviewed, the licensee review, the program review reports should be distrib-should determine .whether the adminimered radio- uted withm the institution to appropriate management i pharmaceutical dosage or radiation dose was in accor- and deperuuents. Corrective actions for de5cient con-dance with the wntten directive or plan of treatment, l ditions should be implemented within a reasonable l as applicable. For example, were the followmg cor- time after identification of the. deficiency.

rect.

the radio -

D. IMPLEMENTATION j

• For radic9 harmaceutical therapy:

i phartuccut cal, dosage, and route of administra- - of this en is m provide hfwma-he 00"' tion to hcensees and applicants regarding the use of e For teletherapy: the total dose, dose per frac- this regulatory guide by the NRC staff. i tion. treatment site, and overall treatment period; was @,ed fw #c cornment to e For high dose-rate remote afterloading brachy- encourage public participation in its de71 aa==aat he therapy: the radioisotope, treatment site, and to- public comments were used in thie develops'nent of this tal dose, ,

Enal agulM guiA W in h cases k which a e For all other brachytherapy prior to implantation: heensee or an applicant proposes an acceptable aher-the radioisotope, number of sources, and source native method for complying with specified portions of strengths; after implantation but prior to comple- the NRC's regulations, this regulatory guide will be tion of the procedure: the radioisotope, treat- used by the NRC staff in evaluating quality manage-ment site, and total source strength and exposure ment programs for the administration of byproduct tine (or, equivalently, total dose); material or radiation from byproduct material.

se 8.33-8 l

b l

' BIBLIOGRAPHY 3

) American Association of Physicists in Medicine, "In- Protection," Report No. 40 ICRU, Bethesda, Mary-land,1986.

s formation that Should Be Included in Every Patient's "

Radiotherapy Treatment Record (External Beam)tal j Radiolopcal Physics Center, M. D. Anderson Hospi International Comminainn on Radiation Units and j and "namor Institute. Houston, Texas,1985. Mmms, " Radiation Dosunetry: X-Rays and Gamma Rays with W w=nen Photon Energies ,

1 American Association of Physicists in Medicine, Between 0.6 and 50 MeV," Report No.14, ICRU,

{ " Physical Aspects of Quahty Assurance in Radiation Washington, DC,1969.

'Iherapy," AAPM Report No.13, American Institute Interstitial Collaborative Working Group (L.L. Ander- l

of Physics, New York,1984. son et al.), Interstitial Brachytherapy

Physical, Bio '

{ American Association of Physicists in. Medicine, k s, ve Pe, j " Specification of Brachytherapy Source Strength," (#d'orky 19 *

AAPM Report No. 21, American Institute of Physics, Johns, H.E., J.R. Omninah=

7he Physics of Radi-

New York,1987. ology, Charles C Thomas Publisher, Springfield, Illi-nois,1983.

! American College of Medical Physics, " Radiation Control and Quah'ty Assurance in Radiation Oncology; Joint r a==. . n on Accreditation of Healthcare AS sted Protocol," Report No. 2, ACMP, Louis. Organizations, " Accreditation Manual for Hospitals."

i ville, entucky,1986 JCAHO, Oakbrook Terrace, Illinois,1990.

i ' American College of Medical Physics, " Radiation Joint Comsniss, ion on Accm&tation of Healthcam Control and Quality Assurance Surveys-Nuclear Organizations.

ity Assurance,,, The Joint JCAHO, Commisalon Guide to Qu Chicago,1988.

l Medicine; A Suggested Protocol," Report No. 3,

! ACMP, Louisville, Kentucky,1986. Kramer, S., D. Herring, "The Patterns of Care Study:

4

American College of Nuclear Physicians, "Ouidelines A Nationwide Evaluation of the Practice of Radiation l Therapy in Cancer Management," International Jour-8 for Quality Assurance in Nuclear Medicine Practice," nel of Radiation

Oncology-Biology-Physics, Vol.

Section III of ACNP Inspector's Manual, Publication 1(11/12), pp.1231-1236,1976. '

. No. 88-6, ACNP, Washinatan, ~

DC,1988. I

' . Moores, B.M., et al., Practical Guide to Quality American College of Radiology, "ACR Standards for Assurance in MedicalImaging, John Wiley and Sons, j j Radiation Oncology," ACR, Reston, Virginia,1990. Inc., New York,1987.  ;

I

~ American College of Radiology, " Physical Aspects of National Council on Radiation Protection and Meas-i Quality Assurance," ACR, Reston, Virginia,1990. urements, " Protection inst Radiation from ,

Brachytherapy Sources," it No. 40, NCRP,  !

. American College of Radiology, " Quality Assurance in Washington, DC,1972.

j Radiati Th py, A Manual for Technologists,"

" **8 '

"A Protocol for the Determination of Absorbed Dose from High-Energ ,

.! Diamond, J.J., G.E. Hanks, S. Kramer, "The Struc- Medical Physics,Vol.10(6),

y_ Photon pp.and Electron Beams,"

741-771,1983. l j ture of Radiation Oncology Practices in the Continen- ' Rhodes, B.A., ed., Quality Controlin Nuclear Medi-

tal United States," International Journal of Radiation

cine, C.V. Mosby, St. Louis, 1977.

Oncology-Blology-Physics, Vol. 14, pp. 547-548, A 1988. Shalek, R.J., " Radiological Physics in a Cancer Center and Other Comments," in Frontiers of Radiation j Eckelman, W.C., S.M. Levenson, " Chromatographic 7herapy and Oncology, University Park Press, Balti- '

Purity of Tc-99ta Co , " in B.A. Rhodes, ed., more,1973. .  ;

tr I in le edicine, pp. 197-209'

. Society of Nuclear Medicine, Quality Assurance Re-source Manual for Nuclear Medicme,, SNM, New i

I Oagnon, W.F., et al., "An Analysis of Discrepancies York,1990.

Encoumered by the AAPM Radiological Physics Cen- G l l ,

ter," Medical Physks, Vol. 5(6), pp. 556-560,1978. .harkschall' Quality As sura.* nce"Proceedmgs of aEquipment,"

of Radiotherapy Symposium on l Gilbert, S., et al., "Quahty Assurance Resource Man. American Association of Physicists in Medicine, Kan-ual for Nuclear Medicine," Society of Nuclear Medi, sas City, Missouri,1982.

j cine, New York,1990. United States Nuclear Regulatory Comnussion, i

4 Golden, R., et al., "A Review of the Activities of the " Guide for the ytion of Applications for Medi-AAPM Radiological Physics Center in Interinstitu- cal' Use Programs, Regulatory Guide 10.8. Revision tional Trials Involving Radiation Therapy," Cancer, 2, Washmston, DC, A,ugust 1987.

. Vol. 29(6), pp.1468-1472,1972 World Health Organization, "Quah'ty Assurance in 1

Radiation Therapy: Proceedings of a Workshop i Oray, J.E., Quality Control in Diagnostic Imaging, December 2-7,.1984 at Schloss Reisenburg," WHO, j Aspen Pubb'shers, Inc., Rockville, Maryland,1983. Geneva,1988.

~

j International Commission on Radiation Units and World Health Organization " Quality Assurance in

Measurements, "The Quality Factor in Radiation Nuclear Medicine," WHO, Geneva,1982.

8.33-9

REGULATORY ANALYSIS A separate regulatory analysis was not prepared ines the cost and benefits of the rule as implemented for this regulatory guide. 'Ihe regulatory analysis pre- using the guide. A copy of the regulatory analysis is pared for the amandment, "Quahty Management Pro- available for inspection and copying for a fee at the gram and Misadministrations," to 10 CPR Pan 35 NRC Public Document Room, 2120 L Street, NW.,

provides the regulatory basis for this guide and exam- Washington, DC.

i l

l I

a

. l O

a 4

7 833-10

m - m- r--a-. B 4 n- a -b +4 - -e J 4 -sA- & D -dm-a rw 6 ,-4 4 = -- M Ae w6 rswmsa aA,s e -6-w 4

0 a

l t

J i

4 Attachment 3

)

d j

TABLES I Table 1: Results Summary - All Regions Totallettersincluded 1709 Type 1 35 Type 2 278 Type 3 1228 '

Negative Declarations 168 Teletherapy Gamma HDR Brachy- I-125 and/or Other Radio-Stereotactic Brachy- therapy I-131 Radio- pharmaceutical Radiosurgery therapy pharmaceutical Therapy uses Etters sent out to date for this 129 3 101 520 1568 modality 1019

Licensees which provided a 126 3 75 435 1347 881 QMP for this rnodality 1

Missed any part of Objective 1 89 % 112 100 % 3  %% 72  %% 3 73 83 % 1114 80% 709 j (Written Dimetive)

Missed Objective 2 (PatientID 2% 3 0 0 1% 1 7% 32 4% 54 4% 32 Verification)

Missed any part of Objective 3 63 % 79 100% 3 63 % 47 65 % 282 0 0 0 0 (Treatment Plans Verification) 1 Missed any part of Objective 4 29 % 37 0 0 92 % 69 80% 347 31 % 414 30 % 263 (Each administrationin accordance with W.D.)

Missed any part of Objective 5 62 % 78 67% 2 55 % 41 54 % 237 59 % 794 56 % 495 (Unintended Deviations)

Missed evaluation and 75 % 94 100% 3 63 % 47 69 %

response to recordable events 301 71 % %1 69 % 608 Missed any part of periodic 93 % 117 100% 3 91 % 68 89 % 388 89% 1201 89 % 783 review requirenwnts

Missed any of "Other" 90 % 114 100% 3 91 % 68 94 % 407 93 % 1256 93 % 819 requirements Deft September 9,1994 37 Tables Attachment 3

4 O

l l

I 1

i Attachment 4 1

1 a aug g i UNITED STATES g ,g* NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20665-4001

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NRC INSPECTION MANUAL NMSS/IMAB TEMPORARY INSTRUCTION 2800/025 0UALITY MANAGEMENT PROGRAM AND MISADMINISTRATION RULE. REVISION 1 APPLICABILITY: Medical Licensees Required to Implement a Quality Management Program 2800/025-01 PURPOSE This Temporary Instruction (TI) implements the inspection procedure for the rule entitled Quality Management Program (OMP) and Misadministration Rule (the Rule) which amended regulations governing therapeutic administrations of byproduct material and certain uses of radioactive sodium iodide. This Rule also modified the notification, reporting, and record keeping requirements related to misadministrations. The TI establishes areas of inspection and creates a procedure for determining compliance with a performance-based rule. The primary focus of the inspection is to assess the licensee's OMP for implementation and execution of policies and procedures for meeting the objectives and requirements of the Rule. The inspection emphasis should be directed at the licensee's OMP for identification (monitoring) and evaluation (assessment) of deficiencies, and implementation of corrective actions to prevent recurrence of the deficiencies.

Additionally the inspection should underscore the licensee's OMP for ensuring a continuous improvement process for enhancing the effectiveness of the Rule.

The Rule represents a major increase in the emphasis the Nuclear Regulatory Commission (NRC) places on radiation safety of patients. Patient radiation safety should be given equal priority with protection of workers and other members of the public. Given the number of significant changes made by the Rule, inspection plans at medical institutions should give priority to this Temporary Instruction as described below.

In order to minimize the impact of the increased inspection resources to complete this TI, regional managers should implement the following guidance to inspectors regarding those items of Inspection Procedure 87100. Appendices A and B. which may be deferred during the time this TI is in effect. Any open items in the, areas specified should be examined and closed.

Inspectors of teletherapy programs may defer items 4: 6; 7: 9. A.B.C.0: 12.A.C.E:

14: 16: 17: 19: and 20 in Appendix A.

Inspectors of nuclear medicine programs and brachytherapy programs may defer items 4: 5: 6: 7: 10: 11: 12: 13.A.B. and G: 17 and 18 in Appendix B.

Inspectors of medical programs of broad scope may defer items in Appendix G provided that deferred items are scheduled for inspection at the time of the next inspection.

Issue Date: 07/12/95 2800/025. Rev 1

Inspectors should not defer items if the inspection is an initial inspection. .

Inspections of programs that do not require quality management plans (e.g., in vitro. nuclear cardiology, small diagnostic nuclear medicine, and diagnostic seahd sources) should be completed in accordance with Inspection Procedure 87100.

2800/025-02 OBJECTIVES 02.01 To determine whether medical licensees are complying with the requirements established in the final rule which amended 10 CFR Parts 2 and 35.

This rule requires applicants or licensees to establish and maintain a written OMP to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

Additionally. this rule requires licensees to conduct reviews and evaluations; maintain records: furnish modifications, and provide notifications and reports, if necessary to the NRC.

02.02 To collect information to determine the effectiveness of a performance-based regulation at reducing the number of mistakes or errors in the delivery process of therapeutic radiopharmaceuticals, therapeutic radiation from byproduct material, and certain quantities of radioactive iodine: and thus minimizing the {

occurrence of misadministrations. The results of this analysis will provide a j basis to determine if modifications to the Rule or comprehensive rule-making is -

4 necessary. l 02.03 Examine licensee OMP performance as a result of review of OMP plans and/or misadministrations.

2800/025-03 RESPONSIBILITIES AND AUTHORITIES 03.01 Director. Division of Radiation Safety and Safeauards. Ensure that regional inspections of medical licensees includes a performance-based review of the licensee's OMP for each type of medical moda'ity, and a review of the l information-collection and reporting requirements related to the Rule.

03.02 Branch Chief. Division of Radiation Safety and Safeauards

a. Ensure that inspection data is entered into the Inspector Follow-up System (IFS).

b. Ensure that copies of the following documents for licensees described in the PURPOSE section are forwarded to the Headquarters Coordinator in NMSS for two years after issuance of this TI for analysis:

1. Copies of all completed "0M Field Notes" (Attachment A).

2. Copies of all inspection reports (if generated).

3. Copies of all Form 591s issued.

c. Ensure that proper instruction on the implementation of this TI is provided to regional inspectors.

d. In cases where licensees are not in compliance with the Rule, initiate appropriate follow-up action.

2800/025. Rev 1 Issue Date: 07/12/95

s 03.03 Materials InsDector. Division of Radiation Safety and Safeauards

a. On every inspection of licensees described in the PURPOSE section, inspect the licensee's OMP in accordance with the requirements in this TI.

b. On every inspection of licensees described in the PURPOSE section, ins)ect the notification. re)orting, and recordkeeping requirements of the Rule in accordance with t7e requirements of this TI.

03.04 Headauarters OM Coordinator. Medical and Academic Section. Medical and Academic Commercial Use Safety Branch. NMS$

a. Receive and assemble from the regions the following documents for licensees described in the PURPOSE section:

1. Copies of all completed "0M Field Notes" (Attachment A).

2. Copies of all inspection reports (if generated).

3. Copies of all Form 591s issued.

b. Compile and enter the results of the information collected in Item

03.04(a) above into the NMSS OM Tracking System.

I

c. At the completion of the pilot inspection program review implementation of the pilot inspection program and revise NRC Inspection Procedure (IP) 87100. " Licensed Materials Program." to incorporate guidance on quality 3 management programs.

2800/025-04 INSPECTION REQUIREMENTS The following requirements shall be completed for every inspection of medical l

licensees who are required to implement, as applicable. a OMP.

04.01 The inspector shall determine licensee compliance with 10 CFR 35.32 and i 35.33, as applicable. If the licensee is not in compliance, then the region should take appropriate enforcement action.

j 04.02 The regional inspector shall complete the "0M Field Notes" given in

Attachment'A. as applicable.

04.03 Within 30 days of completion of an inspection the inspector shall send a copy of the completed "0M Field Notes", any related inspection reports generated. the results of the inspection when documented on Form 591, and any Notices of Violation, to the Headquarters ON Coordinator in NMSS.

! 04.04 The inspector shall' submit the completed "0M Field Notes" with the

licensee's other inspection documents, to be filed in the official docket file.

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2800/025-05 GUIDANCE General Guidance

' a. The Rule applies to those medical licensees who are authorized to possess

, and use byproduct material for applications involving the following modalities:

Issue Date: 07/12/95 2800/025. Rev 1

L Quantit'iesigreater1.han30metrocaries tM either sodium iodide I-125 .  :

or 14131:

i

.2 . Tirerapecit 'adminin.imurt of a mi'cpharmaceutical, other than i sodium trduie F125 or MGl:.

2 Brachytherapy.. Mciluhrg @@-krw-Rae Remote Afterloading and Struntiom-99 eye arpp'ricefcca:

4. Te?etintvpy. and

5. Gamma Stereotard: 'Raisosarprj.

b. Focus on the licensee's overaTl effectM tmplementation of their QMP.

using a performance-based an;roath, rather than a specific compliance approach to all details of foe progra. The inspector is not expected to delve into the spedfins r/f a prograa crea (e.g. . the dose distribution generated by a dose calculating comuter program in teletherapy) though the licensee may have subscribed to the use of a specific device (e.g. ,

computerized treatment planning system) or process (e.g. , manually-generated dose distributions using isodose curves) in their Oif. uowever, the inspector is encouraged to perform an in-depth revlew of a program area if the licensee appears not to follow, or be sufficie.,tly instructed or kr.awledgeable, in the policies or procedures regarding that program area (e.g. . failure to redundantly identify the patient). The intent of the inspection is to determine if the licensee effectively implements policies and of the Rule. procedures designed to meet the objectives and requirements If the inspector identifies potentially important technical weaknesses. the inspector should consult with regional management to determine if additional followup is necessary Additionally, place emphasis on reviewing the licensee's implementation '

of a continuous improvement process in the OMP. This review should include (1) the monitoring process - is the licensee looking for unintended deviations (e.g., errors mistakes, or omissions) that could lead to a misadministration: (2) the identification process - is the licensee finding unintended deviations (e.g., through reviews or representative sampling) that could lead to a misadministration: (3) the evaluation process - is the licensee making assessments of the unintended deviations (e.g., what, when, how, or why the events occurred. including

-an analysis of any trends and patterns) that could iead to a misadministration: (4) the corrective action process - is the licensee implementing an action plan to fix the unintended deviations that, if not addressed. could lead to a misadministration: and (5) the preventive measures process -

is the licensee institutin recurrence of the unintended deviations (e.g. , g actions to prevent modifications to the i policies or procedures) that could preclude the likelihood of a misadministration?

c. An effective tool in the review of a performance-based rule is observing and interviewing individuals involved in the various modalities of .

material use that require a OMP.

Review the licensee's policies and procedures for instruction of supervised individuals in the OMP. Verify that the staff training has occurred. Inspectors should interview individuals present. If an apparent failure in the OMP is identified, determine whether the failure could be attributed to poor. inadequate, or no instruction in the area of the failure. Determine if the failure is isolated, broad or involves other individuals. Additionally, determine if the failure represents an implementation problem involving only specific areas of the department's OMP. or general aspects of the institution's entire OMP.

2800/025. Rev 1 Issue Date: 07/12/95

. .~ ~- - . - - = . - . . -.- - - . - - - . - - - - - - - --

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. Soecific Guidance  ;

! Attachment A. "0M Field Notes - Qualit/ Management Prcgram (QMP)."

Descrir; tion. The OM Field Notes for the OMP are provided in the form of an I l

inspection preparation cover sheet and a series of modules, each containing a l

checklist for a specific modality of use. As part of the preparation for j inspection, using Policy and Guidance Directive 3-15. Standard Review Plan for the Review of Licensee Submitted Quality Management Programs, the inspector will review the licensee's submitted OMP and any modifications, and complete the cover sheet of the TI. Appendix A. marking those modalities to be included in the inspection, and verifying that the licensee's written OMP includes those modalities. The inspector should be familiar with the licensees OMP in order to compare the written program with the program as implemented. The inspector should not attempt to determine that the program, as written is acceptable, but

rather should determine as a result of the inspection, that the licensee's i program as implemented, meets the objectives of 10 CFR 35.32. Attach the l applicable modules to the cover sheet for completion during the inspection.

l Insactors will include a copy of module 7, with their inspection packet for l gatlering information regarding events and misadministrations, Module Guidance-Cover all modalities (types of byproduct material use) that are required 1.

to be included in a OMP. Confirm that the licensee has a written OMP(s) that specifically addresses each modality that is utilized by the i licensee. Additionally, address all applicable sections of the interim ,

field notes.  ;

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2. Confirm that the OMP includes written policies and procedures that require i a written directive and program review. ]

l- i A failure of the licensee to' establish a written OMP that covers each l l applicable modality of use is considered a substantial weakness in the l l program.  ;

3. Interview su, ervised individuals (e.g. u:hnologists, dosimetrists, physicists, or physicians) to determine if these individuals are familiar l with and have been instructed to use and follow their QMP (e.g., written policies and procedures that address each objective, and procedures to conduct the required review). Confirm that the licensee has a system in l place whereby the licensee's staff clearly understands the assignment of

! daily activities that relate to the effective implementation of the OMP. l Instruction should be s involves the individual.pecific If any supervised to the modality of material individual has not use that received training and the inspector cannot determine if this failure is an isolated case, then interview as many individuals as possible. Ascertain any pattern of failures to instruct and train individuals. Inspectors should i

document the names and positions of all individuals who have not received l training. Additionally, document the reasons given for the failure to instruct as stated by the individual. the radiation safety officer, and

, the supervising authorized user.

4. Confirm that.the licensee has selected and reviewed a representative sample of patient administrations within each 12 month period. The  ;

licensee may use any representative sample provided it is a statistically valid methodology to confirm that there are no previously unidentified '

recordable events or misadministrations. Regulatory Guide 8.33 provides Issue Date: 07/12/95 2800/025. Rev 1

an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used. '

any table is acceptable.

5. Inspectors should select a random sample of patient administrations (e.g.,

a minimum number of randomly selected patient cases) to review for each modality (See example page 1 of Attachment A). Determine the number of administrations to select and review in each modality by using the following multi-step process:

a. Request licensees to provide the total number of procedures requiring a written directive, per modality, for the full calendar year prior to the year in which the inspection is being conducted.

Additionally, the inspector should note the number of written directives prepared from January 1 of the current year to the date of the current inspection.

b. A target sample is calculated, using the table supplied in Attachment A. If recordable events are identified in the review of the target sample for a specific modality, the target sample should be increased until the inspector believes he has assessed the extent of the problem. In order to eliminate any bias in the sample, the procedures to be reviewed should be selected randomly. Document the total number of procedures performed per modality.

6. Based on the review of the representative sample (s), confirm that the objectives for each modality have been met and that appropriate records were retained.

7. Weaknesses in Objectives should be discussed in the Remarks sections.

Insxctors should indicate who was contacted regarding this potential weatness and suggest followup on the next inspection.

8. If the licensee failed to follow their QMP procedures, it may not necessarily be a violation. The inspector should determine if the objective was met . The inspector should make the licensee aware of any identified weaknesses.

9. Authorized users may exercise medical discretion where delays to prepare a written directive would jeopardize the patient's health. Sample such patient administrations to verify proper documentation of the oral or sitten revision.

10. Ask if written revisions made to existing written directives are properly documented tp.rigr to administration.

11. Ask individuals to explain how the patient's identity is verified by more than one method, prior to the administration, as the individual named in the written directive. If possible, observe the individuals to confirm their understanding and effective implementation of the department's redundant identification procedures in their QMP.

12. Interview individuals (e.g., radiation oncologists or radiation therapists, neurosurgeons. clinical medical physicists, dosimetrists, or i radiation therapy technologists) in each applicable modality who are involved in the final plans for radiation therapy treatment of patients.

Ask individuals to explain how they verify that the final plans of treatment and related calculations are in accordance with the written 2800/025. Rev 1 Issue Date: 07/12/95

. directive. Confirm that the licensee performs checks of dose calculations. If the licensee uses treatment planning or dose calculating computer programs for dose calculations, ask it the licensee has implemented procedures for acceptance testing before first use of the program for patient dose calculations. The inspector is not expected to evaluate the details of the assessment.

13. Inspectors should ask individuals.to explain how the specific details of-the administration are verified, before administering .egh radiation dose or radiopharmaceutical dosage, in order to be in accordance with the written directive.

After administering a radiopharmaceutical dosage or radiation dose, the licensee must make, date, and sign or initial a written record that documents the administered dosage or dose, as a minimum, in the patient's chart or other ap additional check,propriate after therecord. This documentation administration should serve has been performed, forasthe an licensee to compare the prescribed with the administered dosage or dose.

Ask individuals whether any policy exists that requests workers to seek guidance if they do not understand how to carry out the written directive.

Additionally, determine if the department encourages workers to ask questions about what to do or how it should be done rather than continuing a procedure when there is any doubt.

14. Review the licensee's implementation of procedures to identify, ovaluate, and take appropriate corrective action when uncovering any unintended deviations from the written directive. This objective should be a key part of the licensee's continuous improvement process in their QMP and should include procedures for monitoring, identification, evaluation.

corrective actions, and preventative measures. If the licensee identified ,

unintended deviations from the written directive since the last inspection. track the licensee's processing of the unintended deviations I from beginning to end. Ocscribe any unintended deviations from the i

written directive that were identified by yourself. l

15. Examine the licenste's reviews performed at intervals not to exceed 12 i months of their OP for each applicable modality. If the licensee identified any recordable events since the last inspection, the inspector j should review the documentation of the required evaluation and corrective action that was taken by the licensee within 30 days after discovery.

Based on the administrations sampled and reviewed in the target sample, document any recordable events or misadministrations identified by yourself that the licensee failed to identify.

Any idantification by the licensee of misadministrations that were not i subsequently reported to the NRC should be closely reviewed to determine  !

the cause of the licensee's failure to report the misadministration.

16. Verify that any modifications made to the OMP were furnished to the NRC. 4 If the program's effectiveness is compromised as a result, perform an i in-depth review to determine the reason for the failure. 1 Issue Date: 07/12/95 2800/025. Rev 1 l

2800/025-07 COMPLETION SCHEDULE -

Requirements given in this TI shall be completed during all reviews of medical

- licensees both routinewhoandare required special to implement a quality management program, inclu reviews.

2800/025-08 RESOURCES It is estimated that direct inspection effort will range between 1 and 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> with an expected average of 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> per modality to complete this TI. It is expected that the average licensee will have two modalities. The total estimated time to complete the inspection is 5052 hours0.0585 days <br />1.403 hours <br />0.00835 weeks <br />0.00192 months <br /> per year (3.7 FTE per year) assuming 842 inspections are conducted. NMSS anticipates that use of the deferred inspection compensate items discussed in the Purpose section will approximately for this effort.

2800/025-09 EXPIRATION This TI remains in effect until August 1.1996.

2800/025-10 TECHNICAL CONTACT Questions regarding this TI Coordinator. Sally L. Merchant at (301) 415-7874.should be addressed to the Head 2800/025-11 TRAINING REQUIREMENTS Training Sally addressed during FY 1994 sessions with regional staff conducted by L. Merchant.

2800/025-12 STATISTICAL DATA REPORTING All direct routine inspection effort expended as a result of this TI should be charged to code 2800/025 for RITS. If this inspection is reactive. inspection effort expended should be charged to Inspection Procedure 87103.

END

Attachment:

A. Field Notes - Quality Management  !

Program (OMP) l A1. NaI I-125 or I-131 > 30 pCi and Radiopharmaceutical Therapy A2. HDR Remote s terloading Brachytherapy i A3. Brachytherapy (Other than HDR) )

A4. Strontium-90 Eye Applicators i AS. Teletherapy A6. Gamma Stereotactic Radiosurgery A7. Medical Events and Misadministrations i

2800/025. Rev 1 Issue Date: 07/12/95

l i

ATTACHMENT A

( QUALITY MANAGEMENT PROGRAM (OMP_1 OM FIELD NOTES

1. GENERAL i

A. Facility name(s)-

8. License number (s):

C. Docket number (s):

D. Last inspection date(s):

E. Current inspection date(s):

F.

Most recent OMP and certification received by NRC [35.32(e). (f)(2)] Date:

2. PREPARATION A.

Be familiar with the submitted OMP and any modifications in preparation for inspection of the licensee's implemented OMP. Familiarization should focus upon awareness of the submitted program in order to compare the written program with the program as implemented.

3. MODALITIES A.

Identi (s):

module fy licensee procedures and attach appropriate inspection Module-

1. Nal 1-125 or I-131 > 30 pCi and/or l

2.

Therapeutic radiopharmaceutical other than NaI ()Y()N l 3. High-Dose-Rate Remote Afterloading Brachytherapy ( ) Y ( ) N All Other Brachytherapy

4. Strontium-90 eye applicator ()Y()N 5 Teletherapy ()Y()N 6

Gamma Stereotactic Radiosurgery ()Y()N 7

Event (misadministration or other)

()Y()N

()Y()N

4. SAMPLING (Inspector random sample of each modality) l Total vitten Directives Minimum Taraet Samole 1 to 5 All 5 to 100 5

> 100 5%

i Total Total Target Number W.D.* W.D.* Samole Reviewed

1. Prev.Yr Curr.Yr Nal 1-125 or 1-131 > 30 Ci

2. Therapeutic Radiopharmaceutical i

other than Nal

3. HDR remote afterloading brachytherapy

4. Other brachytherapy

5. Sr-90 eye applicator

6. Teletherapy

7. Gamma Stereotactic Radiosurgery l

• Full calendar year l Issue Date: 07/12/95  ! 2800/025. Rev 1

If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or ,

represents a substantial failure of the OMP.

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2800/025 .Rev 1 Issue Date: 07/12/95 i

l MODULE 1 l

GREATER THAN 30 MICR0 CURIES Nal I-125 or I-131  :

AND RADI0 PHARMACEUTICAL THERAPY

1. SUPERVISION A. Supervised individual (s) instructed in OMP applicable to the modality of use [35.25(a)(1)] ()Y()N  :

List individual (s) found to be inadequately trained:

\

2. NaI I 125 or I 131 > 30 mci ( ) N/A ,

OBJECTIVE 1 Number A. Missed  !

A written directive (order for a specific '

patient, dated & sioned by authorized user (a.u.)  :

or physician under supervision of an a.u.) is l prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives, as applicable, contain required dosage information [35.2] ()Y()N C. Exceptions to written directives are documented

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions

2. Oral revisions

( ) Y-( ) N

3. Oral directives

()Y()N

()Y()N OBJECTIVE 2 I

A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)]. ()Y()N Remarks:

i l OBJECTIVE 3 (Does not apply) i -

OBJECTIVE 4

\

i A. Procedures implemented to verify prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures .qay include: (not reauirements)

. 1. Dosage measured prior to administration

2. Dosage confirmed just prior to administration

()Y()N

()Y()N Issue Date: 07/12/95 A1 - 1 2800/025. Rev 1

'i 1

i C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N  !

Remarks:

1 OBJECTIVE 5 i 1

A'. Procedures implemented to ensure that unintended deviations are identified. evaluated, and corrective action taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35.32(c) 35.2] ( ) Y (.) N ,

Dates of events:

2. Recordable events identified by inspector

[35,32(c) 35.2] ()Y()N

3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)]

)

()Y()N <

C. Procedures may include: (not reauirements)

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last  ;

inspection (If yes, also complete module 7)-[35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were not I subsequently reported (If yes, also complete module 7)  ;

[35.33(a)) ()Y()N 1 Remarks: 1 1

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l 2800/025, Rev 1 A1 - 2 Issue Date: 07/12/95 l

3.

Theraoeutic Radiocharmaceutical other than NaI ( ) N/A  !

OBJECTIVE 1 A. A written directive (order for a specific patient, dated & sianed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N l

8. Written directives. as applicable, contain required information, radiopharmaceutical. dosage, and route of administration [35.2] ()Y()N C. Exceptions to written directives are documented  !

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions

2. Oral revisions ()Y()N

3. Oral directives ()Y()N '

()Y()N OBJECTIVE 2 A.

Licensee uses more than one method to verify the  ;

patient's identity [35.32(a)(2)]; ()Y()N Remarks:

OBJECTIVE 3 (Does not apply)

OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures sty include: (not reauirements)

1. Dosage measured prior to administration

2. Radiopharmaceutical, dosage and route of ()Y()N.

administration confirmed imediately prior to administration ()Y()N C.

Record of administration maintained in auditable  !

l form [35.32(d)(2)] ()Y()N i Issue Date: 07/12/95 A1 - 3 2800/025, Rev 1 i

OBJECTIVE 5 ,

A. Procedures implemented to ensure that unintended deviations are identified. evaluated, and  :

corrective action is taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35.32(c). 35.2] ()Y()N Dates of events:

2. Recordable events identified by inspector >

[35.32(c). 35.2] ()Y()N '

3. Misadministration resulted from the unintended deviation (If yes. also complete module 7) ()Y()N

8. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures m y include: (not reauirements) 1

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N.

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were 0.qt.

subsequently reported (If yes, also complete module 7)

[35.33(a)] ()Y()N ,

Remarks:

L

4. PERIODIC REVIEWS OF THE QMP A. Review conducted of the OMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations. including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 3rovides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are usei any table is acceptable.

2800/025. Rev 1 A1 - 4 Issue Date: 07/12/95

l . l l

l_ C. If review identified recordable events or i

misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the OMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made i modifications to meet Objectives [35.32(b)(2)] ()Y()N  !

F. Modifications sent to NRC within 30 days

[35.32(e)] ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N l

[ 5. RESULTS OF REVIEW-l Briefly describe the overall implementation of the OMP and summarize the inspection findings. If necessary, use an attachment. l l

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6. Time spent completing this module: hours

' Issue Date: 07/12/95 A1 - 5 2800/025. Rev 1

. I MODULE 2 ,

HIGH-DOSE-RATE REMOTE AFTERLOADING BRACHYTHERAPY

1. SUPERVISION A. Supervised individual (s) instructed in OMP applicable to the modality of use [35.25(a)(1)] ()Y()N '

List individual (s) found to be inadequately trained-l t

2. OBJECTIVE-1 Number Missed l A. A written directive (order for a specific patient, dated & signed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N ,

B. Written directives contain required information. .

isotope, treatment site, & total dose [35.2] ()Y()N l C. Exceptions to written directives are documented  :

[ footnote to 35.32(a)(1)] ( ) N/A  ;

1. Written revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N ,

Remarks: .

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3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

4. OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N B. Procedures bay include: (not reauirements)

1. Check of dose calculations by an authorized user or a qualified person under supervision  !

of an authorized user who whenever possible  ;

did not make the original calculations ()Y()N  :

Issue Date: 07/12/95 A2 - 1 2800/025. Rev 1

i

2. Performing acceptance testing (based on licensee's l specific needs & applications) on each treatment l

planning or dose calculating computer program that could be used for dose calculations ()Y()N

3. Other, describe:

l l Remarks:

i

5. OBJECTIVE 4 l A. Procedures implemented to verify, prior to

administration, that the specific details are in i accordance with written directive [35.32(a)(4)] ( ) Y ( ) N '

B. Procedures m_e.y include: (not reouirements)  ;

1. Plan of treatment prepared in accordance with i the written directive ()Y()N i

2. Person administering therapy treatment confirms  !

the prescribed radioisotope site. & total dose ( ) Y ( ) N l l 3. Dwell times and positions verified prior to i start of treatment ()Y()N i

4. Verify source position using dummy sources or  !

fixed geometry applicators prior to inserting sealed sources ()Y()N

. 5. Prompt record by the authorized user, of the l

treatment parameters and signing or initialing patient's chart or appropriate record ()Y ()N j

6. Other, describe:

C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N Remarks:

l

6. OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated. and corrective action taken [35.32(a)(5)] ()Y()N

! 1. Recordable event (s) self-identified since the last inspection [35.32(c). 35.2] ()Y()N Dates of events:

1 1

2800/025. Rev 1 A2 - 2 Issue Date: 07/12/95 l

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2. Recordable events identified by inspector

[35.32(c). 35.2] ()Y()N

3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures may include: (not reauirements)

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were not subsequently reported (If yes, also complete module 7)

[35.33(a)] ()Y()N Remarks:

7. 2ERI001C REVIEWS OF THE OMP A. Review conducted of the OMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical samaling methodology. Regulatory Guide 8.33 provides an example using tie acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.

C. If review identified recordable events or-misadministrations, not 3reviously identif'.ed, the review was expanded by t1e licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the OMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days

[35.32(e)] ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N Issue Date: 07/12/95 A2 - 3 2800/025. Rev 1

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8. RESULTS OF REVIEW Briefly describe the overall implementation of the OMP and summarize the inspection findings. If necessary, use ansattachmen*

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9. Time spent completing this module: hours l l

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2800/025, Rev 1 A2 - 4 Issue Date: 07/12/95

MODULE 3 BRACHYTHERAPY (OTHER THAN HDR REMOTE AFTERLOADING)

1. SUPERVISION l A. Supervised individual (s) instructed in OMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:

i

2. OBJECTIVE 1 Number .

Missed A. A written directive (order for a specific -

patient, dated & sianed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient.[35.32(a)(1)] ()Y()N ,

B. Written directives contain required information [35.2]:

1. Prior to implantation: radioisotope, number of sources, and source strengths ()Y()N i

2. After implantation & prior to completion of procedure: radioisotope, site, total source strength & exposure time (or total dose) ()Y()N C. Exceptions to written directives are documented  :

[ footnote to 35.32(a)(1)] ( ) N/A  ;

1. Written revisions ()Y()N

2. Oral revisions ()"()N

3. Oral directives ()Y()N Remarks: l

3. OBJECTIVE 2  ;

A. Licensee uses more than one method to verify the l patient's identity [35.32(a)(2)] ()Y()N l Issue Date: 07/12/95 A3 - 1 2800/025. Rev 1

4. OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N B. Procedures EA.Y include: (not reauirements)

1. Check of dose calculations by an authorized

. user or a qualified person under supervision

of an authorized user who whenever possible

! did not make the original calculations ()Y()N

2. Performing acceptance testing (based on licensee's

! specific needs and applications) on each treatment l planning or dose calculating computer program that could be used for dose calculations ()Y()N

3. Other, describe:

l Remarks:

! 5. OBJECTIVE 4 A. Procedures implemented to verify, prior to administration. that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures may include: (not reauirements) 1 Plan of treatment prepared in accordance with the written directive ()Y()N 2 Pr son administering treatment confirms prescribed l radioisotope, number of sources, source strengths, treatment site loading sequence, & total dose ()Y()N 3 verify source position using dummy sources or fixed geometry applicators prior to inserting sealed sources ()Y()N

4. Prompt record by the authorized user, of the number of sources, the actual loading sequence of sources implanted (location of each sealed source in a tube, tandem, or cylinder) and signing or initialing the patient's chart or appropriate record ()Y()N

5. Ensure that source will not move or dislodge while implanted ()Y()N l 6. Inspect implanted sources ()Y()N i

Frequency:

Inspecting individual trained ()Y()N

7. Other, describe:

C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N 2800/025. Rev 1 A3 - 2 Issue Date: 07/12/95 l

6. OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated and corrective action is taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35.32(c). 35.2] ()Y()N Dates of events:

2. Recordable events identified by inspector

[35.32(c). 35.2] ()Y()N {

3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N

8. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N ,

C. Procedures pjty include: _(not reauirements)

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N

3. Retain a record of items 1 and 2 ( ) Y ( )'N  ;

D. Licensee reported tr+ ; ministration (s) since the last inspection (If yes. 30 complete module 7) [35.33(a)]( ) Y ( ) N 1 E. Licensee identified misadministrations that were agt subsequently reported (If yes, also complete module 7)

[35.33(a)] ()Y()N Remarks:

7. PERIODIC REVIEWS OF THE OM PROGRAM fl0 CFR 35.32(b)1 A. Review conducted of the OMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical samaling methodology Regulatory Guide 8.33 3rovides an example using tie acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.

-Issue Date: 07/12/95 A3 - 3 2800/025. Rev 1

I

I l C. If review identified recordable events or misadministrations not previously identified, the >

review was expanded by the licensee to ensure the '

events were isolated ()Y()N D. Licensee evaluated each review to determine the  ;

effectiveness of the QMP [35.32(b)(2)] ()Y()N  !

E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N i F. Modifications sent to NRC within 30 days l

[35.32(e)] ( ) Y ( ) N ( ) N/A i G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] -()Y()N

8. RESULTS OF REVIEW  !

Briefly describe the overall implementation of the OMP and summarize the  ;

inspection findings. If necessary, use an attachment.

4 i

9. Time spent completing this module: bours l

l r

l l

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i 2800/025. Rev 1- A3 - 4 Issue Date: 07/12/95 j

l MODULE 4 I STRONTIUM-90 EYE APPLICATORS

1. SUPERVISION .)

A. Supervised individual (s) instructed in OMP  !

applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:

2. OBJECTIVE 1 Number I Missed 1 A. A written directive (order for.a specific patient. dated & sianed by authorized user (a.u.) >

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information.

Source strength. site, & exposure time or total dose [35.2] ()Y()N C. Exceptions to written directives are documented ,

[ footnote to 35.32(a)(1)] ( ) N/A 1.. Written revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N P Remarks:

3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

4. OBJECTIVE 3 f

A. Procedures implemented to verify that final plans  ;

of treatment and related calculations are in 1 acc;cdance with written directives [35.32(a)(3)]( ) Y ( ) N i B. Procedures may include: (not reauirements) i

1. Plan of treatment prepared in accordance '

with the written directive ()Y()N l

2. Assess quantity of material remaining after i decay (decay chart or other method) ()Y()N l

3. Other, describe: '

Issue Date: 07/12/95 A4 - 1 2800/025. Rev 1

l

5. OBJECTTVE 4 A. Procedures implemented to verify prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures may include: (not reauirements) l 1. Method used to time the administration ()Y()N

2. Person administering treatment confirms the prescribed site and the total dose, or source strength and exposure time ()Y()N

3. Other, describe:

C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N Remarks:

6. OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events:

N

2. Recordable events identified by inspector

[35.32(c). 35.2] ()Y()N

3. Misadministration resulted from the unintended deviation (If yes also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures may include: (not reauirements) ,

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N i

3. Retain a record of items 1 and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N E. Licensee identified misadministrations that were ngt subsequently reported (If yes, also complete module 7)

[35.33(a)1 ()Y()N 2800/025 Rev 1 A4 - 2 Issue Date: 07/12/95

i l Remarks:

7. PERIODIC REVIEWS OF THE OMP~

i L  !

A. Review conducted of the OMP at intervals no greater '

than 12 months [35.32(b)(1)] ()Y()N l Date of last review:

8. Review includes a representative sample of all patient administrations including all recordable events and i misadministrations [35.32(b)(1)(i)(ii)(iii)] ()Y()N J The licensee should utilize a representative sampling process which  !

embodies a valid statistical samaling methodology. Regulatory Guide  !

8.33 provides an example using t1e acceptance sampling tables of  ;

10 CFR 32.110 and assuming an error rate of 2%. If the tables in '

10 CFR 32.110 are used. any table is acceptable.

C. If review identified recordable events or i misadministrations not previously identified, the i review was expanded by the licensee to ensure the  !

events were isolated ()Y()N L D. Licensee evaluated each review to determine the I effectiveness of the OMP [35.32(b)(2)] ()Y()N E. Based on evaluation of reviews. the licensee made  ;

modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days

[35.32(e)) ( ) Y ( ) N ( ) N/A G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N

8. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary use an attachment.

1

9. Time spent completing this module: hours L

l:

l

! I Issue Date: 07/12/95 A4 - 3 2800/025 Rev 1

9 i

MODULE 5 TELETHERAPY

1. SUPERVISION A. Supervised individual (s) instructed in OMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained: 3 i

l

2. OBJECTIVE 1 Number Missed A. A written directive (order for a specific patient, dated & sianed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information, total dose, dose per fraction, site, & overall i treatment period [35.2] ()Y()N C. Exceptions to written directives documented

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N

3. OBJECTIVE 2  ;

i A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

4. OBJECTIVE 3 '

A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N B. Procedures quty include: (not reouirements)

1. Check of dose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible i did not make the original calculations ()Y()N i

Issue Date: 07/12/95 A5 - 1 2800/025. Rev 1

2. Performing acceptance testing (based or licensee's specific needs and aplications) on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N l

3. Determining transmission factors for beam i

modifying devices before first use and after replacement of the source ()Y()N

4. Output measurements for treatment parameters not addressed in the most recent full calibration ()Y()N

5. Checking dose calculations administration in fractions (procedure should include consideration of number of fractions and specified time within which the check should be performed) ()Y()N

6. Other, describe:

Remarks:

5. OBJECTIVE 4 A. Procedures implemented to verify, prior to administration. that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N B. Procedures may include: (not reauirements)

1. Plan of treatment prepared in accordance with the written directive ()Y()N

2. Person administering treatment confirms the written directive and plan of treatment. At a minimum, the verification of treatment site and dose per fraction ()Y()N

3. Other, describe:

B. Record of each administration or fraction maintained in auditable form ()Y()N *

6. OBJECTIVE 5 l A. Procedures implemented to ensure that unintended

deviations are identified, evaluated, and I corrective action is taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35.32(c). 35.2] ()Y()N Dates of events:

2800/025. Rev 1 A5 - 2 1ssue Date: 07/12/95

l l

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2. Recordable events identified by inspector ,

[35.32(c). 35.2] ()Y()N '

3. Misadministration resulted from the unintended

deviation (If yes, also complete module 7) ()Y()N i B. Procedures implemented to evaluate & respond within 30 ,

days to each recordable event discovered [35.32(c)] ()Y()N

{

C. Procedures may include: (not reauirements) '

1. Assemble relevant facts including cause ()Y()N

2. Identify corrective action to prevent recurrence ( ) Y ( ) N {

3. Retain a record of items 1 and 2 ()Y()N 4

D. Licensee reported misadministration (s) since the last i

-inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N

E.

Licensee identified misadministrations that were not

subsequently reported (If yes, also complete module 7)

[35.33(a)] ()Y()N 3

. Remarks:

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I Issue Date: 07/12/95 A5 - 3 2800/025. Rev 1

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7. PERIODIC REVIEWS OF THE OMP 4

A. Review conducted of the OMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review.

1 B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical samaling methodology. Regulatory Guide 8.33 provides an example using tle acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.

C.  :

If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the

• events were isolated ()Y()N D.

Licensee evaluated each review to determine the effectiveness of the OMP [35.32(b)(2)] ()Y()N E.

Based on the evaluation of reviews. the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N ,

F. Modifications sent to NRC within 30 days

[35.32(e)] ( ) Y ( ) N ( ) N/A G.

Records of reviews including the evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N '

Remarks:

8. RESULTS OF REVIEW Briefly describe the overall implementation of the OMP and summarize the inspection findings. If necessary, use an attachment.

I I

i 1

9. Time spent completing this module: hours i

I 2800/025. Rev 1 A5 - 4 Issue Date: 07/12/95 1

4 MODULE 6 GAMMA STERE 0 TACTIC RADIOSURGERY

1. SUPERVISION A. Supervised individual (s) instructed in OMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:

2. OBJECTIVE 1 Number Missed A. A written directive (order for a specific patient. djltted & sioned by authorized user (a.u.)

cr physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information, target coordinates, collimator size, plug pattern, and total dose [35.2] ( ) Y ( ) N ._ .._.

C. Exceptions to written directives are documented

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions ()Y()N

2. Oral revisions ()Y()N

3. Oral directives ()Y()N Remarks:

3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

4. OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N B. Procedures ny include: (not reacirements)

1. Check of dose calculations Ly an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations ()Y()N Issue Date: 07/12/95 A6 - 1 2800/025. Rev 1

d

2. Performing acceptance t"esting (based on licensee's specific needs and applications) on each treatment planning or dose  ?

calculating computer program that could-be i used for dose calculations ()Y()N i

3. . Plan of treatment prepared in accordance with the written directive ()Y()N 3

4. -Imaging and localization precision assured. ()Y()N j

a. Stereotactic frame aligned and affixed ()Y()N  !

b. Imaging films correctly centered & labeled ( ) Y ( ) N l

5. Verify correct helmet 8' plug pattern selected ()Y()N

6. Verify computer generated dose calculations were correctly entered into unit and that the computer print out shows correct data for the patient -

were used-in the calculations ()Y()N -!

37. Other, describe:

r l

v . ,

f-

' Remarks: ,

l

5. OBJECTIVE 4 l

A. Procedures implemented to verify. prior to i administration, that the specific details are in  ;

accordance with written directive [35.32(a)(4)] ( ) Y ( ) N' l B. Procedures may include: (not reauirements)  !

1. Check of treatment parameters by an authorized u er or'a qualified person under supervision '

of an authorized user who whenever possible did not make the original calculations ()Y()N  :

2. - Verify stereotactic frame coordinates' on the  :

3atient's skull match the plan of treatment ()Y()N ,

3. )erson administering treatment confirms prescribed -

target coordinates, collimator size, plug pattern, and total dose prior to administration ()Y()N

4. Prompt record of treatment parameters and signing or initialing of the patient's chart or appropriate record ()Y()N 1

5. Other describe:  ;

B. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N Remarks: ,

2800/025. Rev 1 A6 - 2 Issue Date: 07/12/95 y g -<m

. i I

6. OBJECTIVE 5 '

~

A. Procedures implemented to ensure that unintended

' deviations are identified, evaluated, and ,

corrective action is taken [35.32(a)(5)] ()Y()N '

1. Recordable event (s) self-identified since the  ;

last inspection [35.32(c). 35.2] ()Y()N  ;

Dates of events:

, 2. Recordable events identified by inspector

[35.32(c) 35.2] ()Y()N t

3. Misadministration resulted from the unintended deviation (If yes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures m_gy include: (not reauirements)

1. Assemble relevant facts including cause 2.

()Y()N Identify corrective action to prevent recurrence ( ) Y ( ) N  !

, 3. Retain a record of items 1 and 2 ()Y()N  !

D. Licensee reported misadministration (s) since the last j inspection (If yes, also complete module 7) [35.33(a)]( ) Y ( ) N ,

t E. Licensee identified misadministrations that were _nqt subsequently reported (If yes, also complete module 7) 6

[35.33(a)) ()Y()N Remarks:

l

7. PERI 001C REVIEWS OF THE OMP A. Review conducted of the OMP at intervals no greater than 12 months [35.32(b)(1)] ()Y()N Date of last review:

B. Review includes a representative sample of all patient administrations including all recordable events and >

misaaministrations [35.32(b)(1)(1)(ii)(iii)] ()Y()N t

The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide r 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable.

C. If review identified recordable events or misadministrations not previously identified the review was expanded by the licensee to ensure the events were isolated ()Y()N Issue Date: '07/12/95 A6 - 3 2800/025. Rev 1

4 D. Licensee evaluated each review to determine the i effectiveness of the OMP [35.32(b)(2)] ()Y()N ,

E. Based on the evaluation of reviews, the licensee made  !

modifications to meet Objectives [35.32(b)(2)] ( ) Y ( ) N ( ) N/A l F. Modifications sent to NRC within 30 days i

[35.32(e)] ( ) Y ( ) N ( ) N/A  ;

G. Records of reviews including evaluation and findings I maintained for at least 3 years [35.32(b)(3)]: ()Y()N

8. RESULTS OF REVIEW  !

Briefly describe the overall implementation of the OMP and summarize the inspection findings. If necessary, use an attachment. ,

t 1

9. Time spent completing this module: hours l i

i i

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2800/025. Rev 1 A6 - 4 Issue Date: 07/12/95

. i 2

j MODULE 7 I I

MEDICAL EVENTS AND MISADMINISTRATIONS  !

1. GENERAL i

, A. Modality of event or misadministration:

I- B. Therapeutic or diagnostic event-

. C. Date of event:

i D. Date of discovery:

E. Identified by:

F. Licensee implemented a OMP for this modality i [10 CFR 35.32] ()Y()N j 2. TRAINING AND SUPERVISION

) A. Supervised individuals instructed in radiation safety  ;

i principles appropriate to their use of byproduct  !

! material [35.25(a)(1)] ()Y()N i

+

B. Supervised individual (s) instructed in OMP applicable  ;

to the modality of use [35.25(a)(1)] ()Y()N i List individual (s) found to be inadequately trained:

x i

e i 3. DESCRIPTION OF EVENT A. Event classified as misadministration [35.2] ()Y()N if yes. 'which paragraph (s) under 35.2 best describes l the event:

' Describe sequence of events leading to misadministration:

, B.

4 t

C. If not a misadministration, describe the event:

D. Number of patients or others exposed / overexposed:

E. Time period:

Issue Date: 07/12/95 A7 - 1 2800/025. Rev 1

F. Occupational workers exposed If yes. describe: ()Y()N G. Licensee evaluation and actions

1. Calculated prescribed and actual doses ()Y()N Prescribed: Actual:

2. Evaluated effect on patient ()Y()N

3. Corrective actions taken to prevent recurrence ()Y()N

4. If licensee did not evaluate or take action.

reason provided:

4. EVALUATION OF THE EVENT A. Cause of event

1. Human error ()Y()N

2. Patient intervention ()Y()N

3. Mechanical error ()Y()N

a. Manufacturer / vendor:

b Serial number: i

c. Model number:  ;

Remarks: '

l l

4 Computer software error ()Y()N a Manufacturer / vendor:

b Version:

i

c. Serial number:

d. Model number:

l Remarks.

l l

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5. Failure to follow OMP l

()Y()N

a. Authorized user [35.32(a)] ()Y()N

b. Supervised individual [35.32(a)(2)] ()Y()N Describe:

2800/025. Rev 1 A7 - 2 Issue Date: 07/12/95

_...._--_-s 1

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4 B. Root cause(s) and contributing factor (s) that led to this incident:

1. Identified by licensee:

4

2. Evaluated by inspector (See IP 87103):

$~

l

5. NOTIFICATIONS A. NRC's Operations Center within next calendar day after discovery [35.33(a)(1)] ()Y()N Report Number and date

B. Referring physician and ()Y()N Patient within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery [35.33(a)(3)] ( ) Y ( ) N (Referring physician may inform the licensee either that he will inform the patient; or that, based on medical judgement, telling the patient would be harmful) .

C. If 3atient was notified, patient also notified in writing witlin 15 days after discovery [35.33(a)(4)] ()Y()N If not within 15 days, date notified:

What information was provided in the report:

D. _If patient was not notified, the licensee notified the responsible relative or guardian ()Y()N If no, licensee documented justification for decision ( ) Y ( ) N Remarks:

Issue Date: 07/12/95 A7 - 3 2800/025. Rev 1

E. Record of misadministration (s) retained [35.33(b)] ()Y()N ,

The record must contain:

Names of all individuals involved i Patient's Social Security number / identification number All documents and correspondence associated with event ,

A brief description of event including why it occurred.  :

effect on the patient, improvements needed to prevent recurrence, actions taken to prevent recurrence.

Remarks:

F. Licensee identified misadministrations that were not subsequently reported [35.3(a)] (') Y ( ) N  :

If yes, briefly describe the reasons for not reporting: (

i G. Inspector identified misadministrations that the  :

licensee failed to identify [35.2. 35.33] ()Y()N l l

H. Licensee submitted written report to NRC within 15 days after. discovery [35.33(a)(2)] ( ) Y (') N l Remarks I

6. CONSULTANTS A. At the time of inspection. NRC medical or scientific consultant is reviewing this case (See MD 8.10) ()Y()N Name of consultant (s):

B. If not case has been referred to a NRC consultant ()Y()N Name of consultant (s):

7. Time spent completing this module: hours i

2800/025. Rev 1 A7 - 4 Issue Date: 07/12/95

A e.

L h

Q Attachment 5 1

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e

MISADMINISTRATIONS 9/13E)7 AmmiiuACT M_" 1 EA me- ---- - - i SEV LEVEL N_9 m uRE 8RACHY, EYE The Ucensee reported a brachytherapy miesdministration occurred during the REFERRING 94- Y 3-APPUCATOR escond of a sedes of three treatments to en eye surface leolon using a St-90 PHYSICIAN'S REQUEST 137 eye applicetor. MISUNDERSTOOD The applicetor containe a sealed source of 50 MCI of St-90. The patient wee to receive 2550 oGy (rede)in a sedes of three equel treatmente. The fleet treatment wee performed es intended. Dudng the eeoond treatment, the treatment time of 19.1 seconde in the written dirootive wee misreed, and the patient received treatment for 1 minute end 9 seconde. The second treatment does wee 3068 cGy (redel instead of the Intended 850 cGy (rede) dose. The third treatment wee not administered. Therefore, the patient's eye received a total does of 3918 cGy (rede), whleh wee 53.6% ebove the total intended dose.

The patient and the referring physicien beve been informed. The Lloenoce states that it does not expect any adverse medical consequences of the BRACHY, EYE The licensee reported a brechytherapy miesdministration involving a dose lose OTHER APPLICATOR then preocnbed i

A patient did not receive the preecribed dose during ophthalmio treatment with St-90. The patient wee to receive 1250-2000 rede during the treatment, but due to personnel error the patient ordy received approximately 107-108 rede.

The patient wee informed that they would have to retum for further treatment.

Update: The NRC conducted e special inspection on 08/03/94. The inspector ,

determined that the physician wee seeisted by a doelmetdet who had not previously been directly involved with the procedure. The physicien requested the applicetor source in order to perform the treatment, the doelmetriot hended him the source with the steirdeos steel meet in piece. The doelmetrist wee unewere the* the meek existed on the source end that it needed to be removed.

The licensee reported a brechytherapy misedministration involving a dose QUAUTY 94- Y 4 BRACHY, EYE APPUCATOR greater then prescribed. MAN AGEMENT PLAN 133 NOT FOLLOWED The prescription for 1000 cGy of St-90 vie e hond held applicetor woe to be i delivered to the patient's eye in 18 seconde. The applicetor wee held in place for a total of 32 seconde insteed, resulting in a dose of 1778 cGy. The physicien holde the surface appRostor to the eye, and the nurse uses a stopwatch to count off the time elepoed. The physicien continued to apply the treatment up to the 30 second merk, waiting for the nurse to eey stop. The St- ,

90 is used at the inciolon site after eye surgery le performed to remove a fibrous growth, to prevent a further recurrence.

Update: The patient wee not notified, se the referring phy loien felt he could better explain the event and the nun consequences.

Update: The NRC conducted on inspection to review the misedministration end during the inspection violations of the licensee's QMP were found. The NRC conducted on Enforcement Conference to review the QMP and corrective Pege 1

MISADMINISTRATIONS 2/13;O7 AE6TEACT CH_"8 EA BuFis- T SmfLEVEL FEc- R URE BRACHY, EYE On November 21,1995, the authorized user propered the written directive INATTENTION TO APPLICATOR (copy etteched) to use the strontium-90 eye applicator to treet the enedial DETAll region of the left eye of the patient. The petient wee treated for pterygium (a growth over the eye which causee gradual blindnees). The written droctive propered by the authodred user included a reference sketch of the left eye end the r*gion to be treeted. The total dose planned,2400 cGy, wee to be delivered in three equel fractione of 800 cGy, each on November 22, 24, and 27,1995. The physiclet completed the strontium-90 eye applicetor time l

coloulation sheet. The second frection involved a different authedred user end e different physicist, however, instructions were given by the first authorized user and physiciet so that the eeoond fraction would occur on schedule es planned. On November 24,1995, The physicist and authorized user 1

-+- n f the timing of the treatment to ensure that 900 cGy would be given.

After the treatment, the resident phyolclan in ettendence commented that the patient chert wee upeide down. The authorized user reallred that the treatment had just been given to the lateral region of the left eye rather then BRACHY, THE LICENSEE REPORTED THE DISCOVERY DURING AN X-RAY REVIEW QUALITY MANUAL THAT ONE OF FOUR IRIDIUM RIS8ONS HAD BEEN IMPROPERLY PLACED IN MANAGEMENT AFTERLOADER THE NASAL PHARYNX AREA RESULTING IN A 26% UNDERDOSE. THE INADEQUATE PATIENT AND REFERRING PHYSICIAN WERE NOTIFIED.

t BRACHY, The licensee reported brachytherapy miesdministration involving e dose to the SOURCE MIGRATION

• MANUAL wrong site.

AFTERLOADER A patient had tr-192 seeds implented into the lung. When the patient wee observed walking a round, en x-rey wee teken to see if the seeds had moved.

The x-rey showed that the catheter hed moved about 3.5 cm end wee in a different bronchiel peesege then the original implent site.

The cause of the catheter movement le unknown, although coughing or e similar violent motion might have caused the movement.

The Licensee's preliminary evaluation le that the patient received 335 to 1120 cGy (prescribed does wee 2,000 cGy) to the treatment site with about 1,300 cGy to en unintended portion of the lung (broncus).

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4 MISADMINISTRATIONS 2/1327 FRiKEDURE ABSTRACT CAUSE EA ENFOR N T SEV LEVEL BRACHY, The licensee reported a brachythetopy miesdministration involving a does to OTHER MANUAL the wrong site.

AFTERLOADER While loading a cancer patient with Co-137 sources, one source wee dislodged end fellinto the patient's bedding. It was found on the floor seven hours later, recovered, and placed in e shielded container and relntroduced into the patient later that night. The ettending physicien, patient and RSO were swore of the situation. The under does wee cateuteted at 8%. This was enade up tn e later treatment. During the opp'ou'me'*'y eeven toure the source wee uneceounted for,it may have subgeeted the patient to en undetermined skin does.

Updete:

Ocenees estemetoe that the vecoe tNgh of the Faf'*"t received e dose of 1034 rede.

BRACHY, THE PATIENT RECEIVED AN UNDERDOSE IN THE SECOND PART OF A TWO PROCEDURE NOT MANUAL PART TREATMENT. FOLLOWED AFTERLOADER THE PATIENT'S FIRST IMPLANT WAS DONE ON MARCH 31,1994 AND THE PRESCRIBED DOS AGE WAS RECEIVED WITHOUT EVENT. HOWEVER,IN THE SECOND PART OF THE BR ACHYTHERAPY TREATMENT WHICH BEG AN APRIL 14,1994 AND ENDED APRIL 15,1995, THREE " TANDEM

• SOURCES OF THE IMPLANT DEVICE WERE INADVERTENTLY NOT INSERTED INTO THE TREATMENT APPARATUS WHICH HAD BEEN INSERTED INTO THE PATIENT.

THE PRESCRIPTION CALLED FOR THE INSERTION OF BOTH OVOID AND TANDEM SOURCES CONTAINING 160 MCI OF CS-137. THE ADMINISTERING PHYSICIAN APPARENTLY OVERLOOKED THE THREE SOURCES AND LEFT THEM IN A SHIELDED CONTAINER. DUE TO THE OM!SSION, ONLY 64 MCI WERE IMPLANTED, AND AS SUCH, THE PATfENT RECEIVED 40% LESS OF THE TOTAL PRESCRIBED TREATMENT DOSE.

BRACHY, The licensee reported a brachytherapy miesdminletration involving a dose that OTHER MANUAL wee 85% less then was prescribed.

AFTERLOADER The NRC is responding to the Uconsee's Technical Assistence Request concerning a brachytherapy error. The Office of General Counsel concluded j that the incident constituted a misedministration.

The following is e description of the incident:

The written directive celled for a dose of 2526 cGy. At the end of the calculeted treatment time, the phyelcian, while removing the Co-137 sources from the ovoide, noticed that there was no Co-137 in the tendem. Therefore the administered dose to the patient was 373 cGy.

Page 3

MISADMINISTRATIONS 2/1327

21=- m,,,acy e.- ga _-=--7 mm 7 SRACHY, The Licensee reported a misedministration involving a Grechytherapy treatment INCORRECT DATA MANUAL resulting in a dose 24% greater then prescribed. USED IN THERAPY AFTERLOADER DOSE PLANNING intended to deliver a total dose of 3,500 rede to point A. The sotual dose delivered to point A wee 4.357 rede, en inoroese of approximately 24%. It wee determined that the linser seonustion oeefflaient use to esloulete does l tables for treatmente using Co-137 seuroes wee in error. Thoretronlos leeued a product devios eiert for the Therettonice Thersplan L Treatment Plenning System to inform usere of date entry probleme.

Update:

Consultant hired. Notification to the patient by letter statoe: Then en error noted in the computer oelouledon of intemet portion of radiation therapy i

treatment, resulting in en inoroese of 24.3% of the precoribed dose: The estuamon wee review by two outelde consultante: and a report will be sont to I the NRC.

INCORRECT DATA 94- Y 4 I ORACHY, The lloenoce reported a brechytherapy miesdministration involving a does that MANUAL wee 31% lose then prescribed. USED IN THERAPY 217 f

AFTERLOADER DOSE PLANNING The patient wee implanted with two co-137 brechytherapy sources into en ovoid appilooter in order to deliver 6600 rede to the uterine lining. During e review of the completed treatment, the liconose's medical phyelcist determined that the wrong tissue volume wee used during the treatment planning process. The Ucensee determined that the treatment of the emeller volume

• resulted in the delivery of 4165 red, a 38% underdose. The patient and the referring phyoloien have been informed.

Update:  ;

The NRC is conReming that Melvin L Gdem, M.D. will seelst the NRC by serving es a phyelcien consultant.

BRACHY, The Ucensee le reporting en apparent miesdministration. A nurse reported that OTHER 94- Y MANUAL the catheter outside a bronchielimplent patient " looked longer *. The radiation 199 AFTERLOADER oncologist observed the patient and it wee apperent that the meterial wee not exeotly in the some spot, but in a reasonable poeltlen and that most of the tumor wee getting the dose. The oatheter wee then tapped in piece. There seems to be e discrepency from information p._ _ _ _ " and what le documented in the chart. One would ecoees the treatment locetion either radiologically or by some pm _ _li ccumented d landmerke on the catheter in relationship to the neoel enetomy.

Update:It appears that the Ir-192 seed shifted during treatment and en unintended eree received a radiation dose. The NRC sont a letter to Nore A.

Jongen. M.D. to confirm that she will eselet the NRC by serving es e consultant.

Update: The NRC conducted a Safety " ._p f - to review the eltcumetences outrounding the movement of the oatheter.

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, i i

MISADMINtSTRATIONS 2/1307 .

e_e == EA h - -- i any m F- -- - = h ihAct I ORACHY, The licensee reported a beachytherapy misedministration involving e dose to PATIENT REMOVED MANUAL the wrong site. SOURCE '

AFTERLOADER A nursing eseletent received a cell from the petient that sometNng wee wrong with Ne catheter. The petient showed her thet the catheter wee leving on top  ;

of No heed end she immediately left to get the nurse. His nurse found the Ir-192 catheter dengNng and leving on top of No head. She immediately left end ceHed for the Redletion Oncologlet end the R$0. She then went boek to the i room. removed the le 192 eethete* from hee head. weing thunt foreope. end

[

pieced it in the feed cerveer.

The catheter moet Mofy wee occident'y oveed out when the pottent put on No [

gleeeee. Assuming worst cose conditione. the dose to the surfeco of No heed would be et most 14 cGy.

2) The referring phyeleien end patient were not notified witNn 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />; (31 the Licensee feited to fumish witNn 13 deve a written report to the patient or the patient's responsible relative.

r BRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION WRONG TREATMENT INVOLVING A DOSE TO THE WRONG SITE. SITE [*

MANUAL AFTERLOADER AN APPLICATOR CONTAINING TWO CS.137 SOURCES,13 MG-RA-EQ 173 MCl) WAS INSERTED INTO THE PATIENT'S VAGINA. THE WRITTEN  ;

DIRECTIVE WAS FOR 6000 RADS SURFACE DOSE IN S3 HOURS. THE  :

SOURCE SECAME DISLODGED INTO THE RESTRAINING GIRDLE AGAINST l THE PERINEUM. THE MOST PR08A8LE LENGTH OF TIME THAT THE  :

CYLINDER WAS LODGED AGAINST THE PERINEUM WAS APPROXIMATELY i 2.5 HOURS. THIS WOULD HAVE RESULTED IN A DOSE OF APPROXIMATELY 886 CGY.

l

[

BRACHY, INCORRECT DATA 94- Y 3 THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION '

INV0:.VING A DOSE GREATER THAN PRESCRIBED. THE THERATRONICS USED IN THERAPY 077 MANUAL  ;

THERAPLAN L COMPUTER USED AN ATTENUATION COEEFICIENT THAT DOSE PLANNING AFTERLOADER WAS 20 TO 25% TOO HIGH. THIS COMPUTER HAS BEEN USED BY THREE INSTITUT10NS: NORTHERN ROCKlES CANCER CENTER. DEACONESS

MEDICAL CENTER AND ST. VINCENT HOSPITAL FROM OCTOGER 1992 TO THE PRESENT. A REVIEW OF RECORDS DETERMINED THAT SEVEN PATIENTS WERE AFFECTED. THE HIGHER DOSES FOR SIX OF THE j

PATIENTS HAS BEEN DETERMINED TO FALL WITHIN NORMAL DOSAGE TOLERANCE. THE SEVENTH PATIENT IS AT THE UPPER LIMIT OF THE ,

TOLERANCE SAND AND IS CONSIDERED A MISADMINISTRATION.THE PATIENT WAS TREATED ON 11/30/93 FOR OVotDS ONLY WITH A PRESCRIGED DOSE OF 2000 RADS EXOCERVEX. U$ LNG TWO 20 MG  :

l RADIUM EQUIVALENT CS.137 SOURCES. DUE TO MEDICAL CONDITIONS OF THE PATIENT, THE TREATMENT WAS CUT SHORT TO A CALCULATED DOSE OF 1486 RADS.

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MISADMINISTRATIONS 2/1307 .

I p ,, n ame ggg sma n ame g - - - - - - - - -

gg SRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMNISTRATION SOURCES SELECTED 93- Y 3 MANUAL INVOLVING A DOSE GREATER THAN PRESCRISED. THE DOSIMETRIST WITH INCORRECT 011-AFTERLOADER ORDERED IR-192 SRACHYTHERAPY RISBONS CONTAINING 7 SEEDS PER ACTIVITY R1880N WITH AN ACTIVITY OF O.79 MCI PER SEED. HOWEVER, T'r4E VENDOR DELIVERED RIBBONS WITH AN ACTIVITY OF O.79 MG-RA-EQ (1.36 MCI) PER SEED. THE DOStMETRtST DtD NOT NOTICE THt$ AND USED THE SEEDS FOR THERAPY. THIS CAUSED TWO PATIENTS TO RECEIVE GREATER THAN THE PRESCRtBED DOSE.

THE LICENSEE RESPONDED TO THE PATIENT NOTIFICATION INQUtRY. THE UCENSEE WAS CITED FOR FAtLUME TO MAKE THE REOutRED NOTIFICATION WITHIN 30 DAYS. THE REFERRtNG PHv$tCIANS WERE NOTIFIED OF THE f MtS ADMtNtSTRATIONS. AND DECIDED NOT TO NOTIFY THE PATIENTS BECAUSE HE BELIEVED TH AT IT WOULD HAVE SEEN HARMFUL. THE UCENSEE REV! SED THE DEPARTMENT'S PROCEDURES REG ARD!NG VERIFICATION OF SOURCE STRENGTH PRIOR TO USE IN ORDER TO PREVENT FUTURE OCCURRENCES.

BRACHY, The licensee reported a brechytherapy misedministration involving a does that OTHER 94- Y MANUAL wee 27.5% lees then what wee preectibed. 269  ;

AFTERLOADER 3 Personnel at the US Novel Hospital, adminietored en under radiation dose to en .!

interveginal tumor using a Wong opplicetor. The preconbed does wee 5000 .

rede; the administered dose wee 3824 rede: (en under dose of 27.5%). There were no adverse consequences to the patient. The Uoensee notified the ,

patient and her physicien of the under dose. Preliminary findings by the Ucensee indicate that the sources were loeded in the applicetor in the wrong order. ,

L i

BRACHY. The Ucensee reported a brechytherapy misedministration involvlig a does to AFTERLOADERIAPPUCA MANUAL the wrong site. '

TOR PLACED IN -

AFTERLOADER WRONG LOCATION A 9.S MCI Ir-192 source wee mispositioned in the patient's brain for 31 hours3.587963e-4 days <br />0.00861 hours <br />5.125661e-5 weeks <br />1.17955e-5 months <br /> before the e ror wee discovered. Two check filme (x-reyel were inconclusive about the position of the source, and the treatment wee terminated. The ,

incorrect volume received 739 oGy while the tumor reoelved about 72 cGy.

The Ucensee believed that no adverse health effects would result.

t' t

.[+

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~. - - .- -- ~ - -~, - -.. --- --- - . - ~ ~ ..~ - - - ~ --- - -~~ . - - - -~ a MISADMINISTRATIONS 2/13S7

__ ,_. AC, .._ SA _ _- , _

ORACHY, The Econsee reported a brechytherapy miesdmirdstration involving e does to OTHER MANUAL' the wrong site.  ;

AFTERLOADER ' I A 25 mci Co-137 source had been ejected from its vaginalimplent site. A nurse discovered the ocurce neer the foot of the patient's bed, notifled the university RSO who pieced the source in e shielded container.

! The licensee believes that the source became dislodged shortly efter the j implant. ,

The Licensee estimetoe that highest dose received by the extremity (foot) wee 13 rede. The whole body does wee estimetod to be 700 mrede.

i The source wee reinserted to continue treatment. No adverse effects are expected, but the licensee le . -' .;its brechytherapy fanh and t j

n.._L, training received SRACHY, - FIVE CS-137 SOURCES THAT WERE USED IN AN APPLICATOR WERE NOT SOURCE MIGRATION 92- Y 3 l' MANUAL THE SOURCES THAT WERE PRESCRIGED. THESE SOURCES MIGRATED 003 AFTERLOADER WITHIN THE APPLICATOR WHEN TH18 WAS NOTED ON A RADIOGRAPH.

j THE SOURCES WERE REMOVED. THE ?ATIENT AND THE REFERRING PHYSICIAN WERE NOTIFIED OF THE MISADMINISTRATION.

THE LICENSEE ESTIMATED DOSE TO NORMAL TISSUE WAS +

APPROXIMATELY 400-500 RADS. THE LICENSEE ADVISED THE NRC THA r 1 NO ADVERSE EFFECTS TO THE PATIENT ARE ANTICIPATED.

THE CAUSES ARE ATTRIBUTED TO THE LICENSEE'S FAILURE TO: (1) -I PROPERLY TRAIN INDIVIDUALS HANDLING BRACHYTHERAPY SOURCES, (2) i ADEQUATELY IMPLEMENT A QMP,(3) DEVELOPE AND IMPLEMENT

, ADEQUATE QMP PROCEDURES. AND (4) PROPERLY LA8EL THE STORAGE VAULT FOR THE BRACHYTHERAPY SOURCES.

I BRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION SOURCE REMOVED BY 94- Y 3 l MANUAL CAUSED BY A VAGINAL IMPLANT BEING REMOVED BEFORE TREATMENT PATIENT 014 AFTERLOADER WAS FINISHED.

I 4

THE SOURCE WAS REMOVED AND HANDED TO THE ATTENDING NURSE WHO PLACED IT ON A WINDOW LEDGE 2.3 METERS FROM THE PATIENT. '[

t j NO OVEREXPOSURE RESULTED FROM THE REMOVAL THE SOURCE SECAME DISLOOGED DUE TO MOVEMENT OF THE PATIENT.

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__.____._____.___m___._____.m__________ _ _ - . _ _ . _ _ _ _ _ _ . . _ _ . _ - __. . _ = _ _ . _ _ _ _ _ - _ _ . _ m-_ __

MISADMfNISTRATIONS 2/13f37 F;_E- - -_"r AASTRACT e.^M** EA EiuF-F- i AEV LEVEL BRACHY, The liconeos reported a brechytherapy misedministration involving dose to the PATIENT REMOVED 94- Y 4 MANUAL wrong site. SOURCE 065 AFTERLOADER The patient had removed the implant in her sleep and ptoced the source on the bed next to her leg. The source wee discovered efter two end one half hours of exposure.

Update:

i The NRC conducted e special une*wtounced inspection to review the misedrededstration. This event to reportabte dee to the feet that the thigh. en unintended does to the skin, received a dose of 672 cGy.

Update: NRC conducted en inspection end violettone of requiremente were identified.

BRACHY, The licensee reported a brechytherapy miesdmirdstration involving a dose that INCORRECT DATA MANUAL wee 50% Greater then prescribed. USED IN THERAPY AFTERLOADER DOSE PLANNtNG The prescribed does wee 1840 rede to the patient's cervix using Co-137 eoeled sources totaling 159.75 rnCI. The prescribed treatment time wee 31 houre.

The wrong date wres entered for planned removal of the sources from the '

patient Wune 9th insteed of the correct date, June 7th). The phyeleien outhorized user identified the error and removed the sources from the patient et 0915 on June 8,1995 (46 hours5.324074e-4 days <br />0.0128 hours <br />7.60582e-5 weeks <br />1.7503e-5 months <br /> poet implant). The patient received a dose of 2440 rede; approximately 50% more dose then prescribed.

The Ucensee hos notified the patient and the referring physician. The Ucensee hee determined that the patient le not likely to have adverse health effects.

RRACHY, A PATIENT WAS SCHEDULED TO RECEIVE A DOSE OF 1500 TO 2000 RAD SOURCE MfGRATION 92- Y 3 10ANUAL TO A TUMOR SITE IN THE UVER. TWO RIBBONS CONTAINING SIX IR-192 196 AFTERLOADER SEEDS EACH WITH A TOTAL ACTIVITY OF 48.25 MCI WERE IMPLANTED, AN X-RAY TAKEN THE FOLLOWING DAY REVEALED THAT THE Ml880NS HAD BEEN DISLODGED. THE LICENSEE NOTED THAT EARUER IN THE MORNING THE DRESSING ON THE WOUND WAS CHANGED AND CONCLUDED THAT THE SEEDS WERE DISLODGED AT THAT TIME. THE R1980NS WERE FOUND TAPED TO THE PATIENT *S ABDOMEN. THE RIB 8ONS WERE REMOVED AND THE LICENSEE EVALUATED THE EVENT.

i A LATER REPORT STATED THAT THE PATIENT RECEIVED 1032 RADS TO THE SKIN AND OVER 1145 RADS TO THE TUMOR AND THAT THE NURSE WHO REMOVED THE SEEDS RECEIVED 7.6 RADS TO THE SKIN OF HER HAND. BRACHYTHERAPY PROCEDURES WERE HALTED UNTIL THE EVENT WAS FULLY REVIEWED AND UNDERSTOOD.

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MISADMINISTRATIONS 211307

s. _ =.;,, m,act e__^'" i EA s+= - m AEV LEVE BRACHY, THE UCENSEE REPORTED A LOST MEDICAL SOURCE. ONE DAY AFTER THE SOUflCE MIGRATION 92- Y 3 MANUAL COMPLETION OF A PATIENT'S TREATMENT FOR CANCER OF THE CERVlX. A 241 AFTERLOADER DOSIMETRIST DISCOVERED THAT A as MCI CS-137 SOURCE WAS MISSING. THE SOURCE WAS ONE OF FOUR IN A FLETCHER SUIT /SDMO  ;

APPLICATOR.

SEE MED RECORD 920013.

RECONSTRUCTION OF THE INCIDENT DETECTED THAT THE SOURCE HAD MIGRATED OUT OF THE PATIENT AND ONTO THE BED ON THE DAY IT HAD j BEEN IMPLANTED. THE SOURCE WAS INADVERTENTLY REMOVED FROM THE ROOM WHEN THE LINEN WAS CHANGED. THE LINEN WAS NOT l LAUNDERED UNTIL THE TREATMENT WAS COMPLETED. THE SOURCE WAS t

OtSCOVERED MISSING AS THE LINEN WAS BEING LAUNDERED. THE RSO i RECOVERED THE SOURCE FROM A DRAIN PLUG OF A COMMERCIAL WASHER.THE SOURCE WAS EXAMINED AND NO LEAKAGE WAS TELETHERAPY OTHER

\

l BRACHY. THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION PATIENT REMOVED MANUAL INVOLVING DOSE TO THE WRONG SITE. SOURCE AFTERLOADER THE MISADMINISTRATION WAS CAUSED BY A DISLODGMENT OF A Rf880N

! OF 1R-192 SEEDS. THE EVENT WAS DISCOVERED WHEN REMOVING THE SOURCES.

UPDATE: I THE ESTIMATED DOSE TO THE BUTTOCKS WAS 101 CGY AND 380 CGY ESTIMATED DOSE TO THE RIGHT BUTTOCK (WHERE THE SOURCE WAS FOUND) THROUGHOUT THE IMPLANT.

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MISADMINISTQATIONS 2/13.'07 ABETRACT CAUSE EA EruFC f ^

- ;-T SEV LEVEL PROCEDURE BRACHY, THE UCENSEE REPORTED A BRACHYTHERAPY MISADMINtSTRATION AFTERLOADER/APPLICA 94- Y 3 MANUAL INVJLVING DOSE TO THE WRONG SITE. TOR PLACED IN 023 AFTERLOADER WRONG LOCATION TEk IR-192 SEEDS WERE POSITIONED IN A CATHETER IMPROPERLY WHICH WA0 DETECTED BY AN X-MAY. THE CATHETER WAS THEN REINSTALLED AT TM*. CORRECT LOCATION.

UPD AT E:

AN INSPECTION REPORT AND A VIOLATION ARE BEING CONSIDERED FOR AN ESCALATED ENFORCEMENT ACTION.

THE PHYSICIAN VERBALLY NOTIFIED THE PATIENT FOLLOWING THE REINSERTION, AND A WRITTEN REPORT WAS PROVIDED WHICH OESCRIBED THE INCIDENT AND INDICATED THE NRC REPORT COULD BE OBTAINED FROM THE LICENSEE.

BRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION SOURCES SELECTED MANUAL INVOLVING A DOSE GREATER THAN PRESCRIBED. WITH INCORRECT AFTERLOADER ACTIVITY AN ERROR WAS MADE IN SELECTING THE CORRECT SOURCES / SOURCE ACTIVITIES. THE RESULT WAS AN APPROXIMATE DOUBUNG OF THE PRESCRIBED DOSE. THE SECOND TREATMENT WILL BE ADJUSTED TO COMPENSATE.

UPDATE:

THE NRC CONDUCTED AN INSPECTION TO REVIEW THE CIRCUMSTANCES SURROUNDING THE MISADMINISTRATION AND COMPONENTS OF THE BRACHYTHERAPY OMP. TWO APPARENT VIOLATIONS WERE IDENTIFIED:

(1) FAILURE TO RFCORD THE ACTIVITIES OF SOURCES REMOVED FROM AND REMAINING IN STORAGE: AND (2) FAILURE TO FOLLOW THE QMP.

BRACHY. THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION AFTERLOADERIAPPUCA MANUAL INVOLVING DOSE TO THE WRONG SITE. TOR PLACED IN AFTERLOADER WRONG LOCATION A PLASTIC TUBE APPLICATOR WAS DETERMINED TO HAVE NOT BEEN FULLY INSERTED AND THE SOURCES WOUND UP lN THE VAGINAL VAULT INSTEAD OF THE UTERINE CAVITY. THE TREATMENT OF THE WRONG SITE ALSO RESULTED IN AN UNDEREXPOSURE WHICH WILL BE COMPENSATED FOR IN FUTURE TREATMENTS. THE LOWER VAGINA RECEIVED A DOSE OF 2700 CGY.

UPDATE: AN NRC INSPECTION REPORT SHOWED AND AN NRC CONTRACTED A CONSULTANT STATED: THERE HAD BEEN AN UNDERDOSE TO THE PRESCRIBED TREATMENT SITE AND THE DOSES TO THE VAGINA WERE NOT EXPECTED TO CAUSE ANY ACUTE OR LATE SEQUELAE. LICENSEE'S QM PROGRAM WAS INADEQUATE TO PREVENT THE MISADMINISTRATION.

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s MISADMINISTRATIONS 2/1337

=.y ; -i'** AEETEACT i N 8 '**  ! EA _ = - - ~ i AEW m ORACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MIS ADMINISTRATION PATIENT REMOVED 93- Y 3

• MANUAL INVOLVING A DOSE TO THE WRONG SITE. SOURCE 179 AFTERLOADER A SOURCE FELL OUT OF AN APPLICATOR FALLING ON THE PATIENTS BED i NEAR HER LEG AND Bt>TTOCK AREA FOR 15 HOURS. THE UCENSEE DID NOT ORIGINALLY REPORT THIS AS A MISADMINISTRATION BECAUSE THE PERCENT UNDERDOSE WAS LESS THAN 10%.

THE MISADMINISTRATION RESULTED FROM AN UNINTENDED AREA (BUTTOCKS) RECEIVING 50 RADS. THE MISADMINISTRATION WAS DISCOVERED DURING AN NRC INSPECTION.

BRACHY, THE UCENSEE NOTIFIED THE AGENCY THAT A MISADMINISTRATION PATIENT REMOVED MANUAL INVOLVING A BRACHYTHERAPY TREATMENT TO THE WRONG SITE. SOURCE AFTERLOACER A PATIENT UNDERGOING BRACHYTHERAPY FOR THE LEFT BRONCHUS '

EXPERIENCED A COUGHING SPASM. DURING THE SPASM, THE PATIENT COUGHED UP THE IR-192 RIBSON. THE RISBON WAS PLACED INTO A BEDSIDE CONTAINER. THE PATIENT'S TREATMENT WAS CUT SHORT.

THERE WAS NO ADVERSE EFFECT ON THE PATIEr?

UPDATE:

OECAUSE THE SOURCES WERE DISPL ACED INTO THE PATIENT'S MOUTH AND THEN LATER REMOVED AND PLACED (UNSHIELDED) IN A TRAY NEXT TO THE PATIENT'S BED FOR A PERIOD OF TIME. THE PATIENT RECEIVED A DOSE OF APPROXIMATELY 1 CGY TO HIS ORAL CAVITY AND A WCLE BODY DOSE OF APPROXIMATELY 0.156 CGY. WHICH CONSTITUTES DOSES TO THIE WRONG TREATMENT SITE.

BRACHY, The Ucensee stetod that 11 fr-192 seeds totaling 58.9 mC were implanted for PATIENT REMOVED .

e bronchief treatment. The seeds were checked and in place et 7:08 p.m. on SOURCE  !

MANUAL AFTERLOADER September 6,1995. At 8:00 e.m., en September 7th, the e theter cor.teining the seede wee found on a night etend near the patient's bed. The Ucensee believes the patient apparently removed the catheter and placed it on the night etend. The Ucensee le seeeeeing the does received by the patient and hospital  !

staff.

The Ucensee further reported that 11 Ir-192 seed totelling S8.9 mci were re-implented et 3:35 a.m., September 8,1995, to resume the bronchiel ,

treatment. Sometime between 3:35 a.rn. and 4:30 a.m., September 8,1995, the patient, who wee in restreinte, meneged to remove the restreinte and removed the catheter containing the seeds.

At 4:30 a.m., nursing personnel observed that the eetheter had been removed and wee on the night etend near the patient's bed. The nurse immedietely i removed the patient from the room, secured the room, which is e comer room Page 11  ;

. . _ _ _ _ . _ _ _ = . . - .- . -. .

MISADMINISTRATIONS 2/1307 g_ = = l

h. Act '

emanes BA __ = - i any m ORACHY, The licensee reported a brechytherapy miesdministradon IrweMng a dose the - AFTERLOADER/APPUCA MANUAL wrong site. .

T0ft PLACED IN AFTERLOADER A physicien identified that the estive leed onde of two of six catheters had WRONG LOCATION been n;: -' . d to the outside of the cheek from the inside of the mouth of a patient. Z.- - revealed that a nurse respondne to e pedont corripisint that the c: aetors were loose had re-taped the oathetere end. Apparently, the nurse did no recognize the seede inside the oatheter beoeuse they were not viellde, and it wee thought that just the noneedve leede had come loose. Due to the diffloulty with the treatment in general, the treatment was terminated.

The total prooorR>ed dooo to the tumor Inside the mouth wee 5.020 cCly. Tne tumor reoelved appromirnetely 2000 oGy less then m M - f beoeuse the treatment was terminated eedy. The Lloonose determined that tte dose to the patient's cheek wee about 70 oGy. The amount of time that the nurse would I have been in proximity of the sources to re-taped them wee mirmnel. The Licensee piene to enhance its training program. The radiation eoes to the nurse's finger wee estimated by the lleensee to be under 4 mrom.

BRACHY, The Iloonsee reported a brechytherapy miesdministration Irwolving a dose that SOURCES SELECTED 95- Y 3 MANUAL wee less then prescribed. WITH INCORRECT 210 AFTERLOADER ACTIVITY A patient wee prescribed to receive 4 sources of Co-137 of 15 me-Re-eq each (37.5 MCI sech 150 mci t'otell. The sources were implented in a deloose applicator to treet cerv 6 cal concer.

On 08/29/95 the souroos were removed and it wee discovered that 4 sources of Co-137 of 10 mg-Re-eq (25 MCI sech,100 mCl totall had been implanted.

This resulted in en under does to the patient of approulmetely 33%. The patient has been informed and there are no adverse sifecto expected to the patient. The ettendmg phyoloien hoe determined that en additional dose to the patient wul not be prescribed to melte up for the under dose.' The original prescribed dose wee 2016 cGy but the patient received 1349 cGy.

The Licenese le investigating the cause of the misedministration .

BRACHY. The licensee reported a brachytherapy misedmir letration involving a dose that

. OTHER MANUAL was 85% lose then prescribed.

AFTERLOADER A patient was prescribed a 1500 cGy dose to each vaginal well. The dose wee to be given by two Co-137 ovoid sources delivered through en applicetor.

After the treatment had been given, the technicien discovered that one of the sources had not been placed into the applicetor. (it was found lying inside the shielded source carrier).

i The Liconese performed a computer oeiculation end hos determined that the patient received 1270 oGy to the right vaginal well (en undenlose of 15.5%),

end 230 oGy to the left well (en underdose of 84.8%). The physicien end patient were advised of the misedministration. s t

)

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i l

A MISADMINISTRATIONS 2/132)7

\ gg gm pr r ame h huggy eatmas h.-.---- ,

SOURCE MGRATION i BRACHY, The Iloonsee reported a brechytherapy miesdministratien involving a does to MANUAL the wrong site. A nurse noticed that a patient had puNed at a broohytherapy +

AFTERLOADER in-plant, dislodging it by ~ -.-ai4 cm.' When the L._^.p wee '

receloulsted,it wee reensed the a dose of about 100 cGy wee reconved by en aree that wee not p.u " - f. The wi M dose wee for 2000 oGy to the tumor during a 50 hout implant. When the nurse chooked the position of the '

cathetere she noticed something odd about the position of one of the  ;

,.c  :. but did not recognize that the catheter had moved on eentimeters from its originalloostion. The redl%. a. .pset, nowever, noted i the movement et 0730 and retumed the oatheter to is originallooetion. The movement of the catheter foculted in a reduced does to the treatment eroe of 1,900 rede,instead of the intended 2,000 rede, it eleo resulted in en

• unintended inorossed dose to nearby tissue of about 300 rede. This unintended does constitutes e miesdminletration. t cause of the oatheter .

displacement to be methode used to escure the catheter to prevent movement. The NRC is continuing its evaluation of the incident to determine if SRACHY, on January 17,1996, the Ucensee reported a potential miesdmirdstration. SOURCE MIGRATION 96- Y 3 .

MANUAL The potential miesdminlettesion involved a patient with en endobronchiel loolon 047 AFTERLOADER who wee proceribed a dose of 1500 rede (1500 cGyl using fr-192.

A single strand of tr-192 seeds, containing 13.6 mci was pieced in a olooed ended catheter within the endobronchus on 01/16/96. That evening the ettending physicien wee notified that the sources mey have become pertially dislodged. On 01/17/96, the physician ordered a chest X-ray end upon l evaluation it wee determined that the sources had moved lato the troches. '

The sources were removed on the afternoon of 01/17/96. The Licensee indiosted that en unintended orgen (trechsel may have received en unpler.ned radiation dose of approximately 270 rede and the intended orgen (endobronohuel received approximately 240 rede. The Licensee le in the process of evolusting this incident including ceueos and doelmetric consequences.' i BRACHY, The patient le a 46 year old women with Stege IV emell cell carcinome of ti;e DEFECTIVE OR FAILED MANUAL cervix metestetic to brain. As port of her menegement, she received redintbn PARTS AFTERLOADER therapy to the pelvis followed by introcavitary implant using a tendom and ovoid. The tendem and ovoide were loaded on 11/10/93 et 1:30 p.m. The '

nurse changed the patient bed pad later that evening and discovered a Cegium-137 ocurce. She immediately called the troering physic!an et approximate!v 9:30 p.m. who told the nurse to use the forcepe and pleoe this source in the .

leed pen located in the petient's room. She did this without incident. The resident on ceIIimmediately went to the Hospital. She viewed the source in the lead pen and identified it es such. She then checked the implant and found it to be in good position with the aftedoeding applicator and the two ovoide to be elightly loose, however, not dislodged. She then checked the right ovoid and found the source well to be empty, ,- . _ _ with the finding of the Cesium.137 soutee that had been repleoed in the leed pen. The reeldent, Dr.

Brennen, then replaced the Coelum-137 Into the right ovoid well and replaced the aftedoeding applicator without incident into the right ovoid, Page 13

i MISADMINISTRATIONS 2/1307 AASTRACT "N EA EiuF ~--- i l KrVREVEL FR G. iid NIE __

BRACHY, h Ucensee notified Region I that on October 20,1995 during the removal of PROCEDURE NOT i

l MANUAL 60 Ir.192 eeede encesed in nylon ribbon from the breast of a patient, the FOLLOWED AFTERLOADER Licensee inadvertently out the nylon ribbon, and left one eeed inside the tumor l within the patient's breest. The pecent had the seed surgically removed eight hours efter discovery and the Ucensee recovered the seed. The surgeon sloo l

removed some of the surrounding tissue. The Ucensee performed a leek test I of the removed esed and determined that there wee no removable contamination. The patient wee surveyed and discharged following the

( ourgery and removal of the seed. The discovery of the dislodged seed wee l made beoed on the poet removal radiologloel survey of the patient. An inventory of the removed seede performed by the radiation esfety officer eleo I indicated that one seed wee missing.

The preecribed treatment plan wee for 87 hours0.00101 days <br />0.0242 hours <br />1.438492e-4 weeks <br />3.31035e-5 months <br />. The dislodged seed remained l

in the tumor volume for en additional eight hours. The seeds were reported to t contain approximately 1.6 mCiIr-192 for a total activity of approximately 96 mCl. The delivered dose due to the one remaining seed wee less then 0.4 BRACHY, A parient undergoing a brechytherapy treatment for utertne eencer received e SOURCE MIGRATION MANUAL dooo to the thigh eree. With approximetely 2.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> remeledng in a 65-hour AFTERLOADER treatment, the templete become seperated from the patient. This roeutted in en exposure of about 58.7 cGy to the thigh eree. No adverse health conooquences are expected.

Besed on observations, the maximum time the source wee in this position wee about 70 minutes. The intended dose to the uterine eroe wee 3250 cGy. The octual dose delivered wee within 1.6% of the proecribed dose.

The liconeee believes the cause of the templete coming loose wee patient intervention. On February 27,1996, the liconeee reported that a medical rnisedministration occurred on the morning of February 24,1986, roeutting ,

from the sources becoming dislodged during the treatmc4 cf a patient for uterine cervical eencer. The patient's prescribed treatment req 6ed the use of 26 interstittel needles with a total activity of 90.92 MCI (3.37 GBq) edministered using a Nuclotron MicroSelectron Low Does Aftedoeder. The preecribed dose wee 3,250 rede (3,250 cGy) delivered over a 65 hour7.523148e-4 days <br />0.0181 hours <br />1.074735e-4 weeks <br />2.47325e-5 months <br /> period.

BRACHY, The liconeee reported a brachytherapy misedmirdstration involving a dose that INCORRECT DATA 96- Y 2 MANUAL was 40% less then prescribed. USED IN THERAPY 004  ;

AFTERLOADER DOSE PLANNING An Individual wee prescribed to receive 2800 rede to en eres to treet overien concer. The treetment wee done using Ir-192 seeds.

1 During the process to calculete the appropriate number of Ir-192 seede a wrong conversion constant wee used resulting in en underdose of 40%. _

Update- I Region IV Inittsted a reactive inspection on 06/06/95, in response to the Uconeee's initial notification. Although the inspection is ongoing, NRC's initial j eseosoment indioetes that one direct cause of the error wee the use of inappropriate date with the treatment planning computer system used to calcu!ste dwe rates and develop treetment piene. ,

r f

4 Pege 14 m

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r MISADMINtSTRATIONS 2/13.07 AASTRACT canas EA h_ ~~T BEV LEVEL FEW2_M +

SRACHY, A cesium source fell out of its bucket and laid between the lege of a patient for IN ATTENTION TO MANUAL about 80 minutes before it wee discovered end removed. DETAIL AFTERLOADER '

On 03/11/96 e cesium source from the oviod fell out of its bucket during insertion, the coelum applicetor had 5 sources. The source laid between the lege of the patient for 80 minutas before It wee diocovered by a nurse. The source wee removed from the bed end then pieced in a pig. Then the source wee reinserted back into the bucket. The patient's celeuteted doee to the mid depth of his femur from the eeeium source wee 150 meede end the esfeutered eurf ace skin does from the coelum soures to No inner tNghe wee 5.487 rede.

The patiente heaeth wee not effected by the coe um source leving between the '

patient's lege for 90 minutee. ItSO es.d that he had inform Region ill of this event. One of these coe.um sourese le equivalent to 13.938 mg of radium.

i BRACHY, A written preectlption wee given to the Chief Nuclear Medleine Technologlet QUALITY 94- Y 1 MANUAL for ordering the required seeds. The technologlet insists the order wee placed MANAGEMENT PLAN 150 IMPLANT oorrectly end the phermecy made a mietske and sent 112 seeds with activities NOT FOLLOWED of 4.49 mci per seed,instead of 0.43 MCI per seed.

The seede were taken out by the dosimetriot from the storage aree. The phyelcist noted the entryin the log book me *112 seeds with activities of 4.49 MCI per seed." He thought that the entry wee in error and " corrected

• It by changing the entry to *0.449 MCI per seed." The physiclet took the seeds to the operating room and the surgeon implented them into the patient.

The dosimetriot, while reviewing the records of the receipt of the seeds, noted '

the error. The surgeon and the petient were notified and a decision was made to remove the seeds.

Most of the seeds were removed and approximately 42 seede still remained inside the patient. While removing the oeode, one of the seede wee punctured and some personnelin the operating room were contaminated. The liconeee hee conected the contaminated blood and other meterial. ,

BRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTRATION IN ADEQUATE TRAINING MANUAL INVOLVING A DOSE THAT WAS LESS THAN PRESCRISED.

IMPLANT THE TREATMENT PRESCRIBED WAS FOR 58 l-125 SEEDS (0.31 MCI EACH)

TO BE PERMANENTLY IMPLANTED IN THE PROSTATE GLAND USING NEEDLES GUIDED BY AN ULTRASOUND IMAGE. RESULTS OF THE PATIENT *S X-RAY AND CT SCANS REVEALED THAT 2 OF THE 58 SEEDS WERE ELIMINATED IN THE PATIENT'S URINE. ALSO,21 OF THE S6 g

• REMAINING SEEDS WERE LOCATED IN TISSUE SUMMOUNDING THE PROSTATE, NOT IN THE PROSTATE. ACCORDING TO THE NRC ABNORMAL OCCURRENCE REPORT THE PRINCIPAL CONSEQUENCE OF THE EVENT WAS UNDERDOSAGE TO THE PROSTATE. THE LOSS OF THE TWO SEEDS WAS NOT ADDRESSED.

THE LICENSEE CALCULATED THAT THE DOSE TO THE PROSTATE WAS 5,000 RADS INSTEAD OF THE INTENDED 12,000 RADS. NO FURTHER PATIENT TREATMENT WAS PLANNED SINCE THE PATIENT HAD BEEN PREVIOUSLY TREATED FOR THE CONDITION WITH A LINEAR ACCELERATOR.

Pege 15

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MISADMINISTRATIONS 2/13E7 w_ = = w ;,;g e - -- -ma __----- i aaw m SRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMNISTRATION LEAKING SOURCE 94- Y MVOLVING A LEAKING SOURCE. MEDICAL MISADMMISTRATION OSS MANUAL IMPLANT MVOLVING LEAIGNG 10 DINE-128 SEED. SIXTEEN 1-128 SEEDS RANGING 4 FROM 10-30 MCI WERE EACH IMPLANTED IN THE BRAM OF A 30 YEAR OLD MALE PATIENT. FOLLOWING THE EXPLANT PROCEDURE.1-12S AND TL-201 CONTAMMATION WAS FOUND IN THE SURGICAL ROOM AND IN THE SATHROOMS USED BY THE PATIENT. LICENSEE DETERMINED ONE OF THE IMPLANTED SOURCES HAD LEAKED DURING THE IMPLANT PROCESS SY BEMG DAMAGED BY A SURGICAL STAPLE. . THYROID MONITORING ON ALL PATIENT, VISITORS AND EMPLOYEES ASSOCIATED WITH THE PATIENT DETERMINED THAT EACH HAD LESS THAN THE MINIMUM DETECTABLE ACTIVITY OF 1.0 NCl. THROUGH PATIENT MONITORING. LICENSEE ESTIMATES THAT APPROXIMATELY S% OF THE FREE l-12S WAS TAKEN UP i M THE PATIENT'S THYROID (108 UCil. LICENSEE ESTIMATES THAT THE UPTAKE WOULD RESULT IN A RADIATION DOSE TO THE THYRotD OF APPROXIMATELY 278 REM.

BRACHY, THE LICENSEE PE8tFORMED A HDR TREATMENT AT ONE OF ITS REGIONAL DEFECTIVE OR FAILED 94- Y 1 REMOTE TREATMENT CENTERS. THE TREATMENT WAS TERMINATED EARLY MATERIAL 008 AFTERLOADER. SECAUSE OF THE MASILITY TO GET THE SOURCE INTO ONE OF THE MOR TREATMENT CATHETERS. THE PATIENT WAS SENT SACK TO HER NURSONG HOME WHERE SHE DIED FIVE DAYS LATER. THE CATHETER WITH THE SOURCE IN IT HAD FALLEN OUT OF THE PATIENT ON THE DAY PRIOR TO HER DEATH AND WAS DISPOSED OF IN A BIOHAZARD WASTE CONTAINER. THE WASTE CONTAINER WAS PICKED UP BY A COMMERCIAL MEDICALWASTE DISPOSAL COMPANY FIVE DAYS LATER AND TAKEN To

' AN INCINERATOR WHERE THE RADIATION WAS DETECTED. THE ENTIRE SHIPMENT WAS RETURNED TO THE WASTE DISPOSAL COMPANY. THE i-DISPOSAL COMPANY PERFORMED A SEARCH OF THE WASTE AND NOTIFIED THE TREATMENT CENTER THAT RADICACTIVE MATERIAL FROM I

THEM HAD BEEN PICKED UP AT THE NURSONG HOME. THE TREATMENT CENTER RETRIEVED THE SOURCE AND REPORTED THE LOSS TO THE NRC l WHO INITIATED AN INVESTIGATION.

BRACHY, The locenoce reported a brechytherapy misedminletration involving dose that INCORRECT DATA 94- Y 4 was greater then preecribed. USED IN THERAPY 118 REMOTE AFTERLOADER, DOSE PLANNING HDR A patient received a radiation dose of 2500 cGy insteed of the ..ee.* M dose of 2000 cGy. The preecription celled for e change in the treatment length from 8 cm to e new length of 6 cm.

1 The does wee calculeted using precalculated loodose piene and the inwevee equere law wee eseumed. thus oeuse the error in treatment time. The physicien elected not to tell the patient.

The Quality Menegement Procedure for using the HDR were not followed in  !

that the procelouleted table values were modified using a .. ^^ - - ;; not spoeified by the ia-n M end the treatment plan wee not verifled by the physicist prior to administering the treatment.

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a MISADMINISTRATIONS 2/1357 -

ABSTRACT e_maar EA Wr;c- i SEV M g._ "-M BRACHY, The licensee s oported a brachytherapy misedministration involving dose to the INCORRECT DATA wrong site. USED IN THERAPY REMOTE AFTERLOADER, DOSE PLANNING HDR The Ucensee reported that while propering to edminleter e second frectional dose on May 9,1995 en error meeeege wee received at the HDR treatment console. The treetment bed been set-up veing the "end-seek" function of the HDR unit end due to en error in entering certein treatment peremeters, en error message refeting to the cathetoe leagth mee geaeested. The meeeege wee genereted when the end of the eetheter woe not encountered by e

• dummy

• cource se it traveled a destence e<sual to the programmed catheter length.

Ucensee steff prope'+ng to perfonn the treatment were unable to proceed and had to conteet the manuf acturer.

The Ucensee wee informed by the manufacturer that use of the "end-seek" mode might not be oppropriete given the specific set-up for this particular treatment. This prompted the Keeeler AFB medical staff to review the recorde BRACHY, The liconeee reported a brachytherapy miesdministration involving dose that INCORRECT DATA wee greater then p*escribed. USED IN THERAPY REMOTE DOSE PLANNING AFTERLOADER.

HDR A medical rnisedminletration occurred while performing a veghel irradiation with a HDR Aftertoeder Unit.

The prescribed dose wee 600 cGy the octual dose wee 1250 cGy. The cause wee en operator error involving the use of en incorrect decay factor. The error wee discovered during a quality review.

The patient's physician hee been informed. No adverse clinical effects are expected.

Update:

The Ucensee has not notified the patient.

BRACHY, THE UCENSEE REPORTED A BRACHYTHERAPY MIOADMINISTRATION AFTERLOADER/APPUCA 93- Y INVOLVING DOSE TO THE WRONG SITE. TOR PLACED IN 018 REMOTE AFTERLOADER, WRONG LOCATION HDR THE MISTAKE WAS MADE WHILE INSERTING THE AFTERLOADER APPUCATOR IN PREPARATION FOR A HDR TREATMENT. PATIENT DISCOMFORT AND MOVEMENT RESULTID IN THE APPUCATOR BEING INSERTED IN THE RECTUM INSTEAD OF THE VAGINA. THE RESULTING DOSE TO THE VAGINA WAS HALF OF THAT PRESCRIBED. THE MISADMINISTRATION WAS DISCOVERED UPON TERMINATION OF TREATMENT.

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w MISADMINISTRATIONS 2/1307 g.y.r_ mggacy e__. gg - - - - - - - - - - -

ggy m ORACHY, THE LICENSEE REPORTED A BRACHYTHERAPY Mt$ ADMINISTRATION INCORRECT DATA 93- Y 4 REMOTE INVOLVING DOSE TO THE WRONG SITE. USED IN THERAPY 133 AFTERLOADER, DOSE PLANNING ,

HDR CALCULATION ERRORS BY THE PHYSICIST AND DOstMETRtST WERE THE CAUSE OF THE MISADMINISTRATION. DURING ADDITIONAL NRC REVIEW OF THE INCIDENT, IT WAS DETERMfMED THAT THE CAUSE WAS AN i

ISOLATED RATHER THAN A PROGRAMMATIC FAfLURE TO PERFORM AN INDEPENDENT CHECK OF THE TREATMENT DATA PR:OR TO ADMINtSTERING THE RADIATION DOSE.

i i

SRACHY. The licensee reported a miesdminletration involving a brechytherapy treetment INCORRECT DATA REMOTE to the wrong site. USED IN THERAPY '

AFTERLOADER, DOSE PLANNING HDR The misedministration wee discovered six months later during a records review and occurred because of enincorrect entry of treatment length. The source I cetheter length of 920 mm wee used instead of 992 mm.

A Special Inspection wee conducted by the NRC. t e

BRACHY, The licensee reported a brachytherapy misedministration involving dose to the INCORRECT DATA REMOTE wrong site. During a HDR treetment a 150.5 cm catheter was used. When USED IN THERAPY f

AFTERLOADER, the 150.5 cm length was entered into the computer, it exceeded the system's DOSE PLANNING H)R maximum length ceueing the computer to default to 100 cm.

The result wee that the source did not reech the intended treatment site but t remained outside of the body. The patient receive approximately two rede of radiation dose to the heed. Treatment wee aborted in 46 eeoonde end the computer was reprogrammed. The treatment plan wee then completed.

t The root cause of the misedminletration wee determined to be en erroneous keystroke et the treetment planning computer console. A contributing factor [

wee the failure of permittee etsff to verify the dwell positione for each oatheter y prior to performing the treatment se required by en " Operating Instruction * ,

established by the permittee.

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i MISADMINISTRATIONS 2/1337 *

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I BRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MISADMINISTMATION INCORRECT DATA 93- Y 4 USED IN THERAPY 312 I REMOTE INVOLVING DOSE THAT WAS LESS THAN PRESCRIGED. THE TRANSFER l AFTERLOADER. TUBE BETWEEN THE CATHETER AND THE BRONCHIAL TUBE IN THE DOSE PLANNING HDR PATIENT WAS SO CM TOO LONG. RESULTING IN THE IR-192 SOURCE STOPPING AT A LOCATION OUTSIDE THE PATIENT. THE LICENSEE DETERMINED THE DOSE TO THE LENS OF EYE WAS 1.97 RADS. DOSE TO THE CHIN WAS 4.56 RADS, AND DOSE TO THE THYROID WAS 3.07 RADS.  :

l THIS REPRESENTS THE SAME AMOUNT OF RADIATION THE PATIENT WOULD HAVE RECEIVED DURING A SUCCESSFUL TREATMENT. THE  !

ESTIMATED DOSE TO THE TUMOR LESS THAN S% OF PRESCRISED. THE PATIENT WAS INFORMED THAT THE LICENSEE WAS VISITED BY THE NRC. j THAT THE TRANSFER TUBE WAS INADVEfiTENTLY PLACED BETWEEN THE MACHINE AND THE BRONCHIAL TUDE. THUS NOT ALLOWING THE SOURCE TO ENTER THE BODY, AND THAT NRC HAD DETERMINED THAT IT WAS A I MISADMINISTRATION WITH THE PATIENT RECEIVING PLUS OR MINUS 20%

4 OF THE INTENDED DOSE.

ORACHY, The Noonese reported a brechytherapy misseminletrodon involving does to the INCORRECT DATA 94- Y wrong site. USfD IN THERAPY 118 REMOTE AFTERLOADER. DOSE PLANNING HDR Upon completion of the treatment of a patient with 10 Cl of fr.192, using a Nuclotron High Dose Rate Remoto (HORI efterloeder, ti.e Ucensee found that the HDR unit hed been programmed to deliver the dose et the end of the catheter rather then et 12 cm from the end of the oatheter se specified on the I

tr tm.nt pien.

The error resulted in the 500 cGy dose being delivered to the periphery of the lung insteed of the trechee. Subsequendy, the wrong eroe wee treeted.

The patient hee been informed and the Licensee did not expect adverse effects  ;

to the patient se e result of the miesdministration. .

I e

Immediately following the treatment, the Licensee's medical physiciet realized The liconeee reported a brachytherapy rnisedministration involving dose that DEFECTIVE OR FAILED -

. BRACHY.

f REMOTE wee greater then prescribed. At the end of en Interstitial treatment, the sou ce PARTS AFTERLOADER. wire felled to retract to the shielded storego position. Members of the medical

! HDR etoff followed appropriate emergency procedures for the removal of the needle containing the source wire from the patient. Once outside the patient's body, the Omnitron retracted the source to the shielded position. As e result of the incident, the does to one treatment position wee 1,732 rede wereue the l prescribed dose of 1.000 rede (73.2% overdosel, and another location received a dose of approximately 1.400 rede vereue the prescribed 1.000 rede (40% overdosel. The Licensee believes that the cause of the failure to retract wee a kink in the Omnitron needle through which the source trevoled The Omnitron needle hed been inserted through a biopsy needied in the patient A kink at the interface between the Omnitron neede and the biopsy neede wee apparently caused by a sudden move by the patient. This kink w _.4 -

peevented the source from retracting. When the biopsy needle and the

Omnitron needle were withdrawn, the kink in the Omnitron needle wee relieved Page 19 ,

I

l MISADMINISTRATIONS 2/13,'D7 F C- == AmsJhACT f_" EA __---- i AEV LF.fEL BRACHY, THE LICENSEE REPORTED A BRACHYTHERAPY MtSADMINISTRATION INCORRECT DATA 92- Y 3 .

REMOTE INVOLVING DOSE TO THE WRONG SITE USED IN THERAPY 250 AFTERLOADER, DOSE PLANNING HDR THE UCENSEE REPORTED THAT A PATIENT WAS PRESCRIBED THREE 700 RAD FRACTIONS FROM A HOR AFTERLOADER TO TREAT THE MAIN STEM RRONCHUS. DURtNG THE SECOND TREATMENT THE MEDICAL PHYSICIST SET THE COMPUTER PROGRAM TO POSITION THE SOURCES 7 MM FROM THE END OF THE CATHETER INSTE AD OF 7 CM FROM THE END OF THE CATHETER. ,

THIS ERROR CAUSED THE SECOND FR ACTION TO DELIVER 90% OF THE PRESCRIBED FRACTIONATED DOSE TO UNINTENDED TISSUES AWAY TROM THE TUMOR SITE AND UNDERDOSING THE TUMOR SITE.

THE UNDER DOSE WAS MADE UP DURING THE THIRD FRACTION.

BRACHY, On October 19,1995, a 44 year old male patient wee being treeted for two 1HE UCENSEE FAILED REMOTE eeparate lung tumore, one in the right tung end one in the left lung, TO HAVE ADEQUATE AFTERLOADER, simulteneously with a high does rete (HDR) aftertoeder. As treatment to the WRITTEN AND HDR eecond tumor commenced, en obstruction occurred and the treatment wee APPROVED terminated. The Ucensee discovered that the information for the catheter PROCEDURES.

source routing wee awitched in error G.e., left fung catheter information wee programmed for the right lung catheter and vice verse). As a result of this programming error, the source wee mie-positioned and the wrcng treatment site (upper portion of the right lung) received en unintended dose of 200 rede (200 cGy). N Ucensee immediately re-progremn=ed the information correctly and proceeded with the planned treatment.

The patient le scheduled to receive 400 rede (400 cGy) in four fractione over two days for e total dosege of 1800 rede (1600 cGy) per tumor mese. The Ucensee expects no adverse health effoote will result from the miesdministration. The Ucensee informed the patient of the misedministration.

BRACHY, The medicallicensee reported a brachytherapy misedministration. A 208.68 INATTENTION TO REMOTE GBq (5.64 Cil Ir.192 ocurce wee Inserted inside a catheter into a female DETAll AFTERLOADER. patient's esophegue through her mouth during a high dose rete brachytherapy t HOR cancer treatment. N source should have been inserted 2.5 cm further into the esophegue then it wee in compliance with the written directive. The liconeee stated that there were no adverse medical effects on the patient. The patient's physicien will notify the patient of thle miesdministration. The licensee intende to revloe their procedures to prever t recurrence of this event.

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MISADMINISTRATIONS 2/13fD7 ABSTRACT CM_" EA mw i SEV LEVE FRGi.isunE BRACHY, N William Beaumont Hospital reported a possible theropeutic medical INCORRECT DATA misednerwetretion. USED IN THERAPY s REMOTE  :-

AFTERLOADER, DOSE PLANNING HDR The liconeee wee treeting a pottent for concer. The treatment plon specified 7 ocurce or dwell positions within the treatment site. Prior to the beginning of the first treatment, all but one of the correct treatment peremeters were entered. The treatment plan celled for e step length of 2.5 mm,insteed, e step length wee entered et 5 mm. So when the step length wee altered to the longer length, the length of the treetment volume woe eleo longer. Therefore, the does that wee delivered wee less then the prescribed dose. The first dwell posetion wee octually located outside the treatment site while being in the cylindee. However,it wee located 1* from the patient's perineum which may have resulted in the patient possibly receiving a maximum dose to the skin at the thighe of approximately 500 rede. The licensee does not expect any adverse effects to the petia W. The licenose re-ren the treatment plan 912:00 for that frection and retreeted the patient with the precovibed dose of 500 redo BRACHY, inspectore identified a two patient brachytherapy miesdminlettetion dudng on INCORRECT DATA REMOTE inspection et the licensee's feellity. The misedminletration involved a high ENTERED INTO AFTERLOADER, does rete (HOR) remote efterloader unit propremed with the Incorrect dwell CONTROLLER HDR etop distence causing does to the wrong eito for two patiente. N patients were proecribed to receive 2000 - 2200 cGy (2000 - 2200 red) in five fractione to e treatment site length of 5 cm of vaginal mucose. The HDR unit '

wee intended to deliver the dose over 11 dwell positions, each opeoed or 4 ,e etepped 5 mm sport. The misedministrations were caused by the medical physiciste entering a 10 mm step dietence. The does to the wrong site le estimated to be 312 cGy (312 red). The does missed et the treatment site wee administered later. Both patiente have been notined of the misedministration. A consultent hee been hired by the NRC to evaluate the event.

I i

BRACHY, THE LICENSEE REPORTED A MIS ADMINISTRATION THAT OCCURRED WHEN QUALITY 93- Y 3  !

REMOTE A PAT!!NT WAS TREATED FROM FEBRUARY 10-12 1992. THE PATIENT MANAGEMENT 113-AFTERLOADER, WAS PRESCRIBED 3,248 RADS USING A CS-137 LOW DOSE RATE INADEQUATE LDR AFTERLOADING BRACHYTHERAPY UNIT FOR TREATMENT OF CERVICAL CANCER. THE MEDICAL PHYSICIST CALCULATED THE TREATMENT TIME USING IR-192 DOSE RATE CHARACTERISTICS. THIS ASSUMPTION CAUSED .f DEUVERY FOR A SHORTER TIME. THE ACTUAL DOSE RECEIVED WAS -

ABOUT 2,200 RADS, A 32% UNDERDOSE.

i UPDATE: NRC SAFETY INSPECTION AND NOTICE OF VIOLATION. THE l

MEDICAL CONSULTANT'S REPORT WAS GIVEN.

UPDATE: THE LICENSEE REPLIED TO THE NOTICE OF VIOLATION, AND CONTESTED THE VIOLATION FOR NOT NOTIFYING THE PATIENT. THE REFERRING PHYSICIAN INDICATED To THE LICENSEE THAT NOTIRCATION MIGHT HAVE BEEN HARMFUL TO THE PATIENT, AND THAT HE WOULD CONSIDER NOTIFICATION AT A LATER TIME.

i I

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MISADMINISTRATIONS 2/1307 savLevet as knacT c_A9ar mA pRc- :r uRa WRONG TREATMENT 94- Y 3 TELETHERAPY THE UCENSEE REPORTED TWO BRACHYTHERAPY M!S ADMINISTRATION SITE 102 INVOLVING DOSE TO THE WRONG SITE.

THE FIRST INCfDENT OCCURRED ON 01/07/93, DURING THE ADMINISTRATION OF A SINGLE PREOPER ATIVE INTRA-CAVITY IMPLANT TO A PATIENT U$iNG A MICROSELECTRON LDR AFTERLCADING DEVICE (SN 3031). THE DEVICE EJECTED A RADIOACTIVE SOURCE 18.8 MG-RA-EQ (21.5 MCl) HEYMAN-SIMON CS-137 SOURCE) WITHOUT THE DEVICE BEING PROGRAMMED TO DO SO, AND WITHOUT THE APPUCATOR ATTACHE 0r TO THE CORRESPONDING UMBILICAL TU6E ORIFICE. THE SOURCE LAY NEAR THE PATIENT'S LEG FOR APPROXIMATELY 5 MINUTES AT A DISTANCE OF 3 CM FROM THE NEAREST SKIN SURFACE.

THE UCENSEE ESTIMATED THAT LESS THAN O.1 RAD OF ADDITIONAL DOSE WAS DEUVERED TO THE SKIN SURFACE.

\

MADIOPHAKMACEUTIC RADIOPHARMAC A patient wee scheduled for treatment involving 155 MCI of Re-188 ghton in three perte. The first activity administered wee 78 MCI,75 was scheduled. AL OR DOSE ORDER EUTICAL - T the second scheduled treatment wee for 40 mci but this motivity wee lowered MISUNDERSTOOD by the physicien to 32 MCI due to blockege problems in the patient's kidneys.

The nucteer technologist did not review the physicien order end administered 39.7 MCI resulting in a 24% high doce then intended. The finalinjection wee ,

conceled due to the possibility of exceeding a maximum does to the secrum.

I The Licensee hoe changed their procedures making both the nucieer ,

technologlet and the labeling technologist sign the original prescription form I before the administering phyelcien will okey the final treatment.

Updete: The NRC eent a letter to the Liceneee esking them to conalder placing the patient in the DOE *e long-term enedical follow-up program on persone involved in events sesociated with significent redistion exposure.

WRONG SYRINGE g4- Y 4 RADtOPHARMAC The licensee reported e therapeutic radiopharmaceutical misedrninistration involving a dose to the wrong patient. The wrong patient was administered 4 SELECTED FROM 211 EUTIC AL - D mci of Sr-89. Sr-89 is a bone seeker used to treet concer. The estimated OOS AGE CART bone dose le 250 red. The patient and his phyeleien have been informed.

There is some long term effects to the patient's bone metrow which mey result in a lower bleod count. The Ucenees le currentiv investigeting wave of rapidly removing the Strontium from the patient's syeum. A Confirmetory Action Letter will be leeued to confirm the Uconsee's temporary suspension of Nuclear Medicine procedures. An investigation of thle event wee conducted end it wee determined that the immedlete or direct cause of the error wee the failure of the technologist to reed the pig label, to calibrate, and to reed the eyringe label prior to the administering the isotope. A Confirmetory Action Letter (CAU was leaved to end the Ucenees will, and have token the following ectione:(1) Investigation of the Misedministration. (2) Chief of Staff hee determine that oefe clirdeel practices will be foRowed. (3) Provided the NRC ,

w*th the results of the lwa4:st ,

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MISADMINISTRATIONS , 2/13/97 .

ABSTRACT l c_a_a_m ga I g,g__g. "--T SEV LEVEL PRC.n,EDURE RADIOPHARMAC Under does adminletered to patient's wriet during a therapeutic treatment. QUALITY EUTIC AL - T On 12/08/95, en authorized user (AU) completed a written directive for 0.5 MANAGEMENT mci of P-32 to be injected into e pot t ent's wrist during a therapeutic fNADEQUATE

• treatment. The does wee correctly propered in a single eyringe.

In the procedure room, the AU told the nuclear medicine technologist (NMT) he wented two eyringes; one eyringe to nold 0.5 mCIin e 0.25 ce volume end e second syringe to hold 0.5 MCI in e 0.5 co volume.

The NMT misunderstood the AU's voittet request end thought the AU wanted the original 0.5 MCI volume split into e 0.25 cc eyringe end a 0.5 cc eyringe.

Subsequently, the NMT Instructed e second NMT to propere two new eyringes by dividing the original se follows:

1. Dilute original 0.5 MCI to e 0.75 ce volume

2. Drew one syringe of 0.25 cc volume (reeutting in 0.167 MCI)

3. Drew e second syringe of 0.5 cc volume (resulting in 0.333 MCI)

The AU injected the 0.25 ce dose which contained 0.167 MCI of P-32.

Therefore, the deilvered dose wee 67% lees then its ' scribed dose.

DEFECTIVE OR FAILED RADIOPHARMAC On December 21,1995, a patient with metestetic proetue concer wee givsn en intrevenous injection of liquid St-89 for treatment of bone poln. The PARTS EUTIC AL - T prescribed dose wee 4.9 mci (181.3 MBq). Because of a leek in the intrevenous tubing, the patient received less then the intended dose. The patient and his physicien were informed of the underdose. .

The leeking fluid wee promptly collected and the aree decontaminated. A emell amount leaked onto the treeting physician's skin. The licensee estimates the dose to e emelt eres of the physician's skin to be about 3.5 rem (35 mSv).

The incident wee initially reported to NRC Region Ill (Chicego) on December 21,1995. The license also documentA the incident in e etter deted January 9,1996. In response to regional etsff inquiries regerding the information contained in the letter, the licensee conducted a test to better quantify the amount of leakege from the tubing end the Sr-89 received by the patient.

REFERRtNG 92- Y 2 RADIOPHARMAC THE LICENSEE REPORTED A COMMUMCATION PROBLEM BETWEEN STAFF MEMBERS WHICH RESULTED IN ADMINISTR ATION OF THE WRONG PHYSICIAN'S REQUEST 114 EUTICAL - D NUCLEAR STUDY TO A PATIENT. A HURSE FROM THE REFERRING CLINIC MISUNDERSTOOD MADE THE APPOINTMENT FOR THE PATIENT'S SCAN AND UPTAKE STUDY. HOWEVER, THE INFORMATION WAS ENTERED IN THE PATIENT'S CHART AS A REQUEST FOR A WHOLE BODY SCAN. HOSPITAL STAFF QUESTIONED THE PROCEDURE WHEN THE TIME CAME FOR THE ADMINISTRATION OF THE WHOLE BODY SCAN: HOWEVER NO OTHER WRITTEN DIRECTIVE WAS GIVEN 8Y THE HOSPITAL *S AUTHORIZED USER SO THE TECHNICIAN FOLLOWED THE INSTRUCTIONS ON THE CHART.

THE PRESCRIBED DOSE WAS 10 MCI TC-99M AND 16 UCll-131. THE DOSE GIVEN WAS 4.1 MCIl-131. THE RESULT WAS THAT THE PATIENT RECEIVED 14,300 RADS TO THE THYROID AND 6.25 RADS TO THE WHOLE BODY. THE PATIENT AND THE REFERRING PHYSICIAN WERE NOTIFIED.

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MISADMINISTRATIONS 2/1357 r=- =M AEsiRACT t-  ! EA __--- i amt neuen RADIOPHARMAC THE LICENSEE REPORTED THAT THE REFERRtNG PHYCICIAN MADE AN WRONG DtAGNOSTIC 93- Y 1 EUTICAL - D OR AL REQUEST FOR A WHOLE SODY l-131 SCAN. THE TECHNOLOGtST STUDY OR THERAPY 109 QUESTIONED THIS REQUEST DURING A TELEPHONE CONVERS ATION WITH REQUESTED THE REFERRtNG PHYSICIAN SECAUSE THE PATIENT DfD NOT H AVE THE USUAL DIAGNOSIS FOR A WHOLE SODY SCAN. THE to MCI OF l-131 WERE '

ADMINISTERED IN ACCORDANCE WITH THE PHYSICIAN'S REQUEST HOWEVER NO WRITTEN DIRECTIVE ExtSTED lAS REQUIRED BY 10 CFR 35.32). IT WAS THEN DETERMINED THAT THE PATIENT SHOULD HAVE RECEIVED A THYROtD UPT ARE AND SCAN 820 UCIl-131).THE WHOLE SODY SCAN DOSE OF 10 MCI CAUSED A DOSE TO THE PATIENT'S THYROID OF 27,000 RADS. THE REFERRING PHYSICIAN IS CONTINUING FOLLOW UP CARE WITH THE PATIENT.

SODIUM IODIDE A patient wee to receive a consultation but Insto.ml reeelved a 5 MCI I-131 m.... 2 whole body seen. On October 30,1995, e doctor in Martinsburg. West PHYSICIAN'S REQUEST '

Virginie, errenged for e consultation to take pleos Tusedey morning lOctober MISUNDERSTOOD 31,1995) et the Winchooter Medical Center for one of his patiente in regente to Grevee* Dieseos. Winchester Medical Center inetoed mistakerdy entered into it's computer that the podent woe coming in for e 8-131 whole body seen ifirst mietskel. The second mistake wee that a mediosi technolepise ch e ,

5 mCIl-131 dose for the poteent without a doctor approving the * % The third mietske wee that e doctor signed off on e Quality Menegeme WoA Sheet for the 1-131 dose with properly checking the work sheet. (.. the morning of October 31,1995, the patient wee give the 5 mCII-131, whole '

body scen. (I-131 whole body seen le given only to people after they have had concer therapy.) When the patient returned to the Winchester Mediosi Center .;

on November 3,1995,it wee diocovered that the patient should not have been _

given the 5 MCI,1-131, whole body seen and should have been consulted about het Greves' Dioesee condition. It wee C 4_ :.; determined that the SOOlUM IODfDE - A patient received a 141 uCi oral dose of I-131, which being 20% greater then QUALITY D the established protocollimits of 50-100 uCI, represente a miesdministration. MANAGEMENT PLAN ('

Licensee sent letter to patient notifying her of a doce of I-131, odmirustered to NOT FOLLOWED i her, that wee above the protocol establieh; references on ortlete in *Redletion Research", stating there le no incroesed risk of 1. _ u thyioid oeneer; and

' that the referring physicien wee notified.

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t Pese 24

o MISADMINISTRATIONS 2/1307 ,

FRE- A-URE AmminACT  ! ** " l EA sm - - - i amt Last RADIOPHARMAC The Beeneee reported en 1-131 sodium lodido mesedministro6on involving the REFERRING 94- Y 3 EUTICAL - D wrong redlophermeceutical. PHYSICIAN'S REQUEST 103 MISUNDERSTOOO A patient wee administered a 1 rnCI dose of I-131 Nel for a whole body ocen when no such study wee presortbed. The patient's Health Maintonence Organiastion (HMOl celled the Ucenece's Nuclear Medicine C;a. C and requested e "whole red coR mese test". Because the A i ' e clerk wee not familier with tNo study. ehe reportedly eeked the HMO If they meent e *Whole Sody". The HMO toplied in the effirmative. Ucensee stated that the scheduling oleek believed that the request wee for a whole body l-131 ocen and tNo study wee pieced on the schedule. The technologist did not edequetely review the physicien*e order but insteed reRed on the information &

pieced on the schedule by the scheduling clerk. The Licensee stated that the petient's physicien notified the patient of the miesdminletrodon. Llconese eetwneted that the patient received a whole body dose of 470 mrom and a thyroid dose of 800 rom.

SODIUM IODfDE - PATIENT RECEIVED A 208 UCI ORAL DOSE OF 1-131. THE DOSE NOT REPORTED D REPRESENTED A DOSE GREATER THAN THE CUNICAL PROCEDURE MANUAL AT CMH ALLOWED. WHICH IS 50-100 MICROCURIES. THIS DOSE EXCEEDED THE PRESCRIBED DOSAGE BY MORE THAN 20%. UCENSEE SENT LETTER INFORMING PATIENT THAT SHE RECEIVED AN ORAL DOSE OF l-131 WHICH WAS GREATER THAN THE PROTOCOL ESTA8USHED: THE ACTUAL ABSORBED RADIATION TO THE THYROID GLAND WAS SMALL; THAT HER REFERRING PHYSICIAN WAS NOTIFIED: AND REFERENCES AN ARTICLE ON RADIATION RESEARCH STATING NO INCREASED RISK FOR THYROID CANCER.

SODIUM IODIDE - PATIENT RECEIVED A 208 UCI ORAL DOSE OF 1-131 WHICH P.EPRESENTS A NOT REPORTED D DOSE 20% ABOVE THE PROTOCOL ESTA8USHED IN THE NUCLEAR MEDICINE DEPARTMENT. UCENSEE SENT LETTER NOTIFYING PATIENT OF THE MISADMINISTRATION THAT STATED A DOSE OF l-131 GREATER THAN THE PROTOCOL ESTABLISHED WAS ADMINISTERED TO HEM; REFERENCES AND ARTICLE ON RADIATION RESEARCH. STATING THERE IS NO INCREASED RISK FOR DEVELOPING THYROID CANCER; AND THAT THE j REFERRING PHYSICIAN WAS NOTIFIED.

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i MISADMINISTRATIONS 2/13 C7

' ~~ EA _ _ - - mEVLavet FEC-E Uftf AsmihACT a SODIUM IODIDE - PATIENT RECEIVED A 203 UCI DOSE OF l-131 WHICH WAS A DOSE QUALITY 94- Y 2 GREATER THAN 20% OVER PROTOCOL. LICENSEE SENT LETTER MANAGEMENT PLAN 02S O

NOTIFYING PATIENT OF A DOSE OF l-131. ADMINISTERED TO HER. THAT NOT FOLLOWED WAS HIGHER THAN THE PROTOCOL ESTABLISHED: REFERENCED ARTICLE IN

• RADIATION RESEARCH" STATING NO INCREASED RISK OF THYROID CANCER: AND THAT THE REFERRING PHYSICIAN WAS NOTIFIED.

P SODIUM IODIDE - PATIENT RECEIVED A 134 UCI ORAL DOSE OF l-131. THIS DOSE NOT REPORTED D REPRESENTS A MISADMINISTRATION BEING GREATER THAN 20% ABOVE THE PRESCRISED DOSE AS LISTED IN THE PROCEDURAL MANUAL.

LICENSEE SENT PATIENT A LETTER NOTIFYING HER OF A DOSE OF I-131 ADMINISTERED TO HER. WHICH WAS ABOVE THE PROTOCOL ESTABLISHED: REFERENCES AN ARTICLE IN THE

• ANNUALS OF INTERNAL MEDICINE *, STATING NO INCREASED INCIDENCE OF CANCER: AND THAT THE REFERRING PHYSICIAN WAS NOTIFIED.

i WRONG 94- Y RADIOPHARMAC The liconeee reported en 1-131 sodium iodide miesdminletration involving the EUTICAL - D wrong radiophermeceutical. A miesdminletration wee discovered involving a RADIOPHARMACEUTIC 046 ,

diagnostic emount of I-131 Net. The patient wee preecnbod to receive 0.5 uCi AL of Co-57 cyanocobelemin for e diagnostic achilling's teet by en authorired user. Instead the patient receive 46 uCI of I-131 Net. Both i radiophermeceuticale are administered orallyin capsule fomt.

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e MisADMINISTCATlONS 2113p AissTRACT  ! t"" EA _ _ - - i amt m M9_ _-_-__iM RADIOPHARMACEUTIC SODIUM IODIDE - ALTHOUGH A WRITTEN DIRECTIVE REQUIRED A PATIENT BE GIVEN 5 MCI -

D OF l-131 FOR WHOLE BODY SCAN,10 MCI WAS ADMINISTERED. AL OR DOSE ORDER TECHNOLOGIST WAS UNAWARE OF THE CHANGE IN STANDARD DOSAGE. MISUNDERSTOOD SUT THE TECHNOLOGIST NEGLECTED TO CONFIRM PREPARED DOSAGE n WITH PRESCRIBED DOS AGE IN THE WRITTEN DIRECTIVES. f i

SOD;UM IODIDE - A PATIENT WAS MISTAKENLY ADMINISTERED 83 UCI OF NAIL-131 FOR A REFERRING D THYROID UPTAKE AND SCAN, RATHER THAN THE PRESCRIGED 15 UCI FOR PHYSICIAN'S REQUEST AN UPTAKE STUDY ONLY. NO ADVERSE EFFECTS WERE EXPECTED. THE MISUNDERSTOOD PATIENT AND PHYSICIAN WERE NOTIFIED.

• UPDATE: A SPECIAL SAFETY INSPECTION WAS CONOUCTED. A VIOLATION WAS SERVED FOR FAILURE TO FOLLOW THE QUALITY MANAGEMENT PROCEDURES TO CONFIRM DOSAGE BEFORE ADMINISTRATION, AND FOR FAILURE TO HAVE A QUAUTY MANAGEMENT PLAN THAT SHOULD INCLUDE WRITTEN POLICIES AND PROCEDURES FOR IDENTIFYING, i EVALUATING AND CORRECTING UNINTENDED DEVIATIONS FROM WRITTEN DIRECTIVES.

RADIOPHARMAC The licensee reported on 1-131 sodium lodido misedministration involving a WRONG PATIENT '

dose to the wrong patient. SELECTED EUTICAL - D Two patients were scheduled et the some time and the technologist did not heve the requisition directive with him. Patient was given IPECAC to induce vomiting along with a thyroid blocker.

Update:

Consequence to patient hos been confirmed as none.

Update:

NRC inspection Report end Notice of Vioistion for inedequate Quality Menegement Progrem Page 27 ,

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MISADMINISTRATIONS 2/1307 ABSTRACT e_9 M EA h_+~~i SEY uvEL HiOCEDURE SODfUM IODIDE - PATIENT RECEIVED A 188 UCI ORAL DOSE OF 1-131 WHICH REPRESENTS A NOT REPORTED D DOSE 20% GREATER THAN THAT OF THE ESTABLISHED PROTOCOL IN THE NUCLEAR MEDICINE DEPARTMENT. UCENSEE SENT LETTER TO PATIENT INFORMING HER OF THE MIS ADMINISTRATION. THE LETTER STATES THAT A DOSE OF 1-131 WAS ADMINISTERED WHICH WAS ABOVE PROTOCOL ESTABUSHED: REFERENCES AN ARTICLE IN

• RADIATION RESEARCH".

STATING NO INCREASED RISK Oc THYROID CANCER: REFERENCES AN ARTICLE IN

• ANNUALS OF INTERNAL MEDICINE *, STATING NO INCREASED INCIDENCES OF CANCER: AND THAT THE REFERRING PHYSICIAN WAS NOTIFIED.

REFERRING 94- Y 2 SODIUM IODIDE - A patient wee administered 2.S rnCI of I-131 for a total body scen. The physicien had prescribed en uptake seen which would typiceNy result in 200- PHYSICIAN'S REOUEST 156 D MISUNDERSTOOD 300 uCI of I-123 being administered. A senior technicien diocovered that the I patient wee being treated for e diffuse goiter condition. This condition le not typically treated with en 1-131 total body scen. After further investigetlon it wee determined that the patient should have received en 1-123 uptake seen.

The error wee caused by a new technicien who did not review the doctor *e ordere properly.

NOT REPORTED SODIUM IODIDE - The Ucensee determined that a patient received 160 uCi of I-131 versue 100 D uCi of I-131. This resulted in a higher then expected dose to the patient's thyroid gland. The patient's phyelcien hee been informed. The' estimated dose I to the patient's thyroid le opproximately 600 cGy. The licensee does not expect adverse heelth effects to the pstlent. Efforte to notify the patient heve been unsuccessful thus f ar.

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r MISADMINISTRATIONS 2/1307 <

ABSTRACT l t 4_" l EA murf2- T SEV LEVEL PROCEDURE THE UCENSEE REPORTED AN l-131 SODIUM IODlDE MtSADMINISTRATION QUAUTY NA INVOLVING A DOSE TO THE WRONG PATIENT. MANAGEMENT THE ADMINISTERING TECH WAS INSTRUCTED TO LOCATE A PATIENT INADEQUATE WEARING A CERTAIN COLOR OF SHIRT RATHER THAN CHECK THE PATIENT'S IDENTIFICATION BRACELET. THE RATIONALE WAS THAT PSYCHIATRIC PATIENTS FREQUENTLY REMOVE THEtR BRACELET. THE PATIENT WAS NOT WEAmtNG A BR ACELET AND CONFtRMED THAT SHE WAS THE ONE SCHEDULED FOR TESTING. WHEN THE ERROM WAS REALIZED, A 5-DAY DOSE OF LUGOLS SOLUTION W AS PRESCRt9ED TO BLOCK THE PATIENT'S UPTAKE OF t.131. THE CALCULATED DOSE TO THE THYROIO WAS 4.42 R ADS.

THE PATIENT AND ATTENDfMG PHYSICIAN WERE NOTIFIED OF THE MISADMINtSTRATION. THE TECHNICIAN RECEtVED A WRITTEN REPRIMAND AND THE FACluTY BEGAN A REVIEW OF DEPARTMENT POUCY.

QUAUTY 95- Y 3 SODfUM IODIDE - The Ucensee reported that three misedministratione involving doseges of 249 D sodium iodide 1-131 had been identified. MANAGEMENT  !

INADEQUATE The Ucensee reported that three petiente were scheduled to receive 5 mci dosages of sodium lodide I-131 on September 18,1995, in properation for g

whole body scene to detect metestetic thyroid cercinome. The Ucensee's vendor had shipped the radiopharmeceutical dosee es two 2.5 MCI espoulee per patient (each patient's dose wee in a seperste well. The technologiste involved in this activity detected unuouel radiation levels on the surfoce of the three containere in which the sodium lodido l-131 doses were received, causing them to physically examine the containere. Upon examinatiert of the containers, the staff discovered that only one capsule of each container had been adminletered to the patiente end the second cepeu8e remained in each conteiner. Besed on review of the vendor's recorde end confirmatory esseye completed et the Ucensee's facility, tho Ucensee hee estimated that approximately 50% of the prescribed dosege woe adminletered (the Ucensee REFERRING SODIUM IODIDE - The Ucensee reported a misedministration involving a 1-131 dose. '

PHYSICIAN'S REQUEST D

A patient wee intended to receive e dose of 7 uCl of I-131 for a thyroid upteke MISUNDERSTOOD study. Insteed, the patient received a dose of 77 uCIl-131, the thyroid scen dosege.

No adverse medical consequences resulted and the patient hos been advloed.

Update: On September 28,1995, the Ucensee's consultent reported that a patient wee administered a 77 uCI (2.8 MBq) dose of I-131 sodium lodido for a thyroid upteke study, rather than the prescribed 7 uCI 10.26 MBq).

On the moming of September 21,1995, the Licensee propered doses for two patiente. The two doses were pieced on a counter next to each other. The techno'ogist did not compere the label on the Mal with the patient's -

prescription form and adminletered the wrong dose.

Pege 29

g - - - - - - - - - -

MtSADMINISTRATIONS 2/1307 CAAM I EA h _- - i SEV12 VEL PROCEDURE ABSTRACT SODtUM IODIDE - During a retstine inspection that bogen on September 11-12,1995, the NOT REPORTED inspector identified irregulerities in does administration recorde reisting to two D

diagnostic procedures involving sodium lodido 1-131. As e result of en ongoing inspection and investigation, Region IV staff hee determined that the I-131 doses administered for the two procedures were not in accordenes with the opplicable written directives.

Since the previous inepection conducted on September 16,1992. the Uceneee had performed only two diagnoetic procedures ue!ng geester that 30 uCI of l-131. Theee were whole t oey scene to identify metestetic thyroid carcinome.

The first edministration of I-131 wee en September 6.1994 Authorized usere requested that a dose of 6 mCl be ortrar=etered fnr the procedure. Beeed on information prov6ded by beeneee reoreeentativee end the certiochermeceuticel manuf acturer, Region IV eretf hoe deteermned that the does adrninletered to the patient wee opprovimetely 7.8 MCI. Thus, the deve adminletered wee approximetefy 30 percent greater then the prescribed dose. Accordingfy, thle PROCEDURE NOT SODIUM IODIDE - A medieet licensee reported a misedminletration involving sodium lodido. The D ticonees reported that a patient schedufed to receive 3.7 MBq (100 uCi? l-131 FOLLOWED for e thyroid upteke seen inadvertently wee administered 244.2 GBq (6.6 mCQ l-131 for a whole-body. Follow-up seen. The technologist foiled to verify what procedure wee prescribed and used en unsigned Written Directive. The licenses notified the referring phyeleien and pstient about the misedministration. The licensee does not believe there will be any adverse effects.

fv0T REPORTED 96- Y 3 SODtUM ICDtDE - During a routine inspection that began on September 11-12,1995, the 0 inspector identified irregularitleg in rioso edmirdstration records relating to two 056 diagnostic procedures involving sodium lodido l-131. As a result of en ongoing inspection and investigation, Region IV staff hos determined that the I-131 dosee administered for the two procedures were not in accordence with the applicable written directives.

Since the previous inspection conducted on September 16,1992, the Ucensee had performed only two diagnostic procedures using greater then 30 uCl of l-131. These were whole body econe to identify metestetic thyroid cercinome.

The second wee on November 7,1994, authorized usere requested that e dose of 4 MCI be adminletered for the November 7th procedure. Besed on information provided by Ucensee representatives and the radiopherrneceutical menufacturer, Region IV staff hee determine that the does adminletored to the patient was approximately 5.7 MCI. Thus, the dose administered was approximately 42 percent greater then prescribed. Accordingly, this Pege 30 6

MISADMINISTRATIONS 2/13g7 PROCEDURE ABSTRACT I c_-_A_i_ame EA EigynnesmasasT SEV LEVEL I SOOlUM IOOtDE - A medical licensee reported a misedministration involving sodium lodido. A IN ADEQUATE TRAINING 96- Y 3 0 patient wee preecribed 7.4 MBq (200 uCI) 1-123 for e diegnostic procedure. 157 The licensee ordered the correct lootope but the phermecy delivered 7.4 MBq (200 uCi) 1-131. The nuclear medicine technologlet (NMT) Identified that the incorrect iodine isotope hed been sent, and efthough the NMT could nst locate a written procedure for the 1-131, administered the I-131. The referring physicien het been notified of the misedministration and did not went the patierst notified. The licenses does not expect any adverse effects.

SODIUM IODIDE - A medical licensee reported a miesdministration involving sodium lodido. The WRONG SYRINGE D licensee repor'ted that a techrdoien prepared a 111 MBq (3 MCI) 1-131 does for SEliCTED FROM e patient. The technicien then mietekenly administered a 595 MBq (16.1 MCI) DOS AGE CART l-131 dose from the incorrect viel. The licensee notified the patient of the miesdministration. No adverse effects are enticipated because the patient hos

• already had the thyroid removed.

t SODIUM IODIDE - The I.icensee discovered that a patient was supposed to have received a dose NOT REPORTED T of 3.0 MCI of I-131, but wee administered 3.67 MCI of I-131. On May 17, 1995 the patient was scheduled for a 131-lodined Whc8e Body Scen. The Written Directive ceiled for a does of 3.0 mci of 131-Iodine. A dose of 3.0 mci was ordered from the Nucteer Pharmacy. When the patient arrived for the seen, the technologist essayed the 131-lodine dose et 3.67 MCI. The technologist filled out the Quality Managemant Program Form. On this form the technologist indicated that the does was within 10% of the dose es prescribed on the Written Directive. The technologist eleo indicated that there were no deviatione from the Written Directive. Upon Investigetion of the miesdministration it wee determined that the technologiste had made en error in Judgment end had not willfully felsified the Quality Menegement Program date information. The technologist had not in the poet performed 131-Iodine Whole Body Scene. The technologist did not secociate the Quality Menegement Program with diagnostic procedures, only when a therapeutic procedure was being performed.

Pege 31

MISADMINisTRATlONS 2ft3g7 F - _ ;"_M ABSTRACT l *= EA sm - - -- , ami m SOOlUM IODIDE - UCENSEE REPORTED A MISADMINISTRATION RESULTING FROM A SOURCES SELECTED T RADIOPHARMACEUTICAL DOS AGE DIFFERING MORE THAN 20% WITH INCORRECT A SPECIAL INSPECTION WAS PERFORMED OF THE UCENSEE. ACTIVITY e

RADIOPHARMACEUTICAL ADMINISTERED HAD DECAYED 20 HALF-UVES WHEN ADMINISTERED.

UPDATE:

NOTICE OF VIOLATION FOR NOT FOLLOWTNG THE WRITTEN OUALITY MANAGEMENT PROCEDURES.

UPDATE:

THE NRC CONOUCTED ANOTHER INSPECTION AND THE LICENSEE WAS GIVEN A NOTICE OF VIOLATION FOR MOT FURNfSHtMG TO THE PATIENT OR THE PATIENT *S RESPONSf 8tt RELATIVE. WITHtN 15 DAYS, EITHER:lli A COPY OF THE REPORT THAT WAS SUBMITTED TO THE NRC. OR 12) A BRIEF DESCRIPTION OF THE EVENT AND CONSEQUENCES AS THEY MAY AFFECT THE PATIENT INCLUDING THE STATEMENT THAT THE REPORT SUBMITTED TO THE NRC CAN BE OBTAINED FROM THE UCENSEE.

SCDIUM IODIDE - REPORTED l-131 MISADMINISTRATION - 39% UNDERDOSE. PATIENT WAS OTHER T' TO RECEIVE A DOSE OF 15.8 MCI BY BEING ADMINISTERED TWO CAPSULES, BUT ONLY ONE CAPSULE WAS ADMINISTERED AND THE PATIENT RECEIVED 9.1 MCI OF 1-131. DURING NRC INSPECTION OF EVENT, NO VIOLATIONS WERE IDENTIFIED.

LOSS OF 93 Y 3 SODIUM IODIDE - PATIENT UNDERGOING THIRD TREATMENT FOR HYPOTHYROIDISM RECEIVED 15.1 MCI OF l-131 INSTEAD OF 30 MCI. 9.9 MCI WAS GIVEN ADMINISTRATIVE 027 T

FOR FIRST TREATMENT AND 21.2 WAS GIVEN FOR THE SECOND CONTROL TREATMENT. TWO CAPSULES IN ONE VIAL WERE SHIPPED FROM SQUISB.

NORMALLY ONLY ONE CAPSULEIVIAL IS SHIPPED WHEN DEAUNG WITH -

LOWER DOS AGES. A SECOND CAPSULE WAS NOT NOTICED BY

• TECHNOLOGIST UNTIL 16 DAYS LATER WHEN THE LEAD CONTAINER WAS BEING PREPARED FOR DISPOSAL UCENSEE DID NOT ESTA8USH.

MAINTAIN, OR SUBMIT TO NRC A WRITTEN QUALITY MANAGEMENT PROGRAM.

UPDATE: RESPONSE TO VIOLATIONS. QUAUTY MANAGEMENT PROGRAM IN PLACE. ADDITIONAL TRAINING. PH ARMACEUTICAL CO. TO SEND ONLY ONE CAPSULE PER VIAL. AND CAPSULES WILL BE ASSAYED.

UPDATE: ENFORCEMENT CONFERENCE.

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- _ . . _ . _ _ _ _ _ . _. . . - , ~1 __ - - . .-__. ,_nr ~ , , , ,.,m__ , . . ,..,_,

MISADMINISTRATIONS 2/1307 .

PROCEDURE _ ABSTRACT l CAUSE i EA sui--- - _i AEV LEVEL SODtUM IODIDE - A patient was supposed to receive 8 mci of I-131, however a dose of 29.9 VIALNtAL SHIELD T mci vree administered. The error occurred while deees for two patients were MtSLABELED

. being sessyed et the some time. The two dosee were mietsbeled when the lide of the feed viel shielde were reversed. The fide contained the dose information lebet. The technologist did not check the lid lebete egoinet the Vet lebele, which woufd have detected the error. The patient's refetive wee informed of the misedministration, as the patient does not understand Eng'ieh.

An NRC medical coneuttent will be contacted to evoluete the misedministration.

Update: The NRC conducted en inspection and leeued e Notice of Violation.

The NRC eleo concluded that the rniendministration was en footsted svent end wee not due to e programmatic feiture. The medical coneuttent suggested that there would be no significant consequences.

SODIUM IODIDE - Ucensee reported a miesdministration caused by the administered dose RADIOPHARMACEUTIC T exceeding the prescribed dose by more then 20%. AL OR DOSE ORDER MISUNDERSTOOD Update:

The Ucensee submitted a written report of the incident. Patient Information:

The Licensee wrote to the patient stating that she received a slightly Ngher does then intended, and that it wl!I not cause any significent adverse effects.

SODIUM IODIDE - A patient et Walter Reed Medical Center wee scheduled to rece:ve e dose of INATTENTION TO T 29.9 mci 1-131 through an NG tube. The doctor who was administering the DETAIL does inadvertently injected the dose into the drainege tube from en abdominal wound. The physicien noticed that the wound dressing had become wet, and immediately discovered No error. The drecoing wee removed, and the wound wee cleaned thoroughly.

The Radiopharmaclet estimated the patient's upteke et 6 mCl. A second dose of opproximately 22 mCile being propered, and will be administered to the patient.

Pege 33

MISADMINISTRATIONS 2/1307 FRiX,i&URE ABSTRACT

• ^ "

l EA _ - - i Emf LEVEL The licensee reported e teletherapy miesdministration involving a dose to the INCORRECT DATA 94- Y 3 TELETHERAPY wrong site. USED IN THERAPY 155 DOSE PLANNING During boost treatmente using obilgue fielde of 1400 red, the octuel

)

adminlettetion of the dose for the first end half of the second treetment used '

the wrong ongles. The Ucensee recalculeted the does and the engles chenged so that the dose volume will receive the proper does within the 20% Hmite during the remaining treatments. The Uceneee le implementing a chenge to .

procedures to onouro concietency with equipment placement end simulation results.

Update:

The Ucensee submitted a written report ef the erweedministration end will conduct en internal audit, eftered the elmuletion dote form, and written procedures for the conversion of englee from the almuletor to treatment unit will be instituted and reviewed with technologists.

THE UCENSEE, REPORTED A TELETHERAPY MISADMINISTRATION REFERRING SS- Y 3 TELETHERAPY INVOLVING A DOSE GREATER THAN PRESCRISED. PHYSICIAN'S REQUEST 111 MISUNDERSTOOD A 31 MONTH OLD PATIENT WAS PRESCRISED TWO CO-80 TELETHERAPY I TREATMENTS OF 150 RAD EACH EACH TO REDUCE SWELUNG CAUSED BY .

A BRAIN TUMOR. l l WHILE PLANNING THE TREATMENT THE DOSIMETRIST CALCULATED THE TREATMENT TIME FOR 300 RAD / TREATMENT RATHER THAN THE INTENDED 150 RAD.

THE CALCULATIONS AND TREATMENT PLAN WERE REVIEWED BY THREE i ADDITIONAL INDIVIDUALS PRIOR TO THE TREATMENT. ALL THREE FAILED TO RECOGNIZE THE ERROR SINCE 300 RAD PER TREATMENT FOR A BRAIN TUMOR IS CONSIDERED NORMAL FOR BRA!N TUMORS. THE ERfl0R WAS DISCOVERED BY A STUDENT THERAPY TECHNOLOGIST DURING A REVIEW THE LICENSEE REPORTED A TELETHERAPY MISADMINISTRATION QUAUTY 92- Y 3 TELETHERAPY INVOLVING THE WRONG MODE OF TREATMENT. MANAGEMENT PLAN 228 THE UCENSEE REPORTED THAT DURING ONE FRACTION OF Co-80 NOT FOLLOWED

( TELETHERAPY TREATMENT, A FEMALE PATf *'(AGE 771 RECEIVED 180 l

l I RADS IN THE ROTATIONAL MODE TO THE P " REGION INSTEAD OF THE PRESCRIBED 200 RADS IN FIXED MODE. TI N TIENT ALSO RECEIVED DOSE TO THE LEFT AND RIGHT SIDES OF T n LVIC REGION. THE EVENT WAS CAUSED BY FAILUftE OF THE TECHNI . C A TO VERfFY THE MODE OF THE TELETHERAPY UNIT PRIOR TO TREATid K .

l IT WAS DETERMINED THAT THE CAUSE OF THE MISADMINISTRATION WAS THE FAILURE OF THE UCENSEE TO FOLLOW THE DEPARTMENT'S QMP.

THE UCENSEE'S QMP CALLS FOR TWO RTTe TO BE PRESENT WHEN A PATIENT IS BEING SET UP TO ENSURE THAT THE SETUP IS DONE PROPERLY. THE FIRST RTT DID NOT ENSURE THAT THE SETUP WAS DONE CORRECTLY AND THE SECOND RTT WAS OUT OF THE DEPARTMENT GETTING ANOTHER PATIENT.

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2/13;G7 ,

MfSADMINISTRATIONS I fimas l EA Mr- i SEV LEVK PROCEDURE AssiEACT REFERRING TELETitERAPY THE LICENSEE REPORTED A TELETHERAPY MtSADM'NtSTRATION PHYSICIAN'S REQUEST INVOLVING DOSE GREATER THAN PRESCRI8ED.

MtSUNDERSTOOD THE LICENSEE TREATED THE PATIENT FOR METASTATIC CANCER OF THE RIGHT SHOULDER.

ONE YEAR PREVIOUSLY, THE PATIENT WAS TREATED WITH A DOSE OF 3970 R AD, DURING WHICH, THE DOCTOR PRESCRI8ED 3000 RAD TO SPINE

N 15-200 RAD DAILY FRACTIONS AND 1000 RADS IN FIVE 200 RAD DAILY TREATMENTS TO THE RIGHT SHOULDER.

CONFUSION BETWEEN THE PREVIOUS TREATMENT AND CURRENT TREATMENT RESULTED IN 1400 R ADS BEING DELIVERED TO THE RIGHT SHOULDER IN A SEVEN DAY TREATMENT PERIOD INSTEAD OF 1000 RADS. ANOTHER CAUSE OF MISADMINISTRATION WAS THAT THE PRESCRIPTION WAS WRITTEN ON A 2 SIDED FORM. ONLY ONE SIDE OF THE PRESCRIPTION WAS READ.

The licensee reported a teletherapy misedministration involving a dose to the INCORRECT DATA TELETHERAPY USED IN THERAPY wrong site.

A possible misedminletration occurred for a patient that wee to be treated by a DOSE PLANNING Co-60 source in the eres of the left neck. The treatment wee set up correctly according to the treatment plan, however, the Collimetor wee turned 270 degrees instead of the required 90 degrees. This reeutted in a dose to the right enterior evperclav (shoulder eroa just below the neck) instead of the left enterior neck. A total dose of 90 cGY wee delivered, es expected. The eres that vves treated over-lapred 50% of the area that wee meant to be treated.

The licenses reported a teletherapy rnisedministration involving does greater QUAlfTY 93- Y 3 TELETHERAPY MANAGEMENT 248 then prescribed.

INADECUATE A 92 year old pet!ent received 395 Rede instead of 200 Rede in each of the second through the fourth teletherapy treatmente due to tres* ment I,orformed without using oblique field wedges. Twenty-two treatments were schedufed.

Prior to teletherapy treatment, eight lineer accelerator treatments were scheduled. These were eleo done without wedges, resulting in 2488 Rede given instead of the 1600 Rede prescribed. The first teletherapy treetment wee completed correctly under the direction of the treating physician.

Update: Assistence wee given to the NRC which consisted of Medical Consultation Services.

Update: NRC conducted a specielInspection and eight violations were identified. Also, NRC Consultent Report regarding the incident.

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MfSADF%tSTRATIONS 2/1327 4 ABSTRACT CAUSE I EA Em- - - ~ -- - T amt LEVE PAOCEDURE 3 Between 10:00 end 10:30 A M. e patient wee treeted with two baeme for INCORRECT DATA 94- Y TELETHERAPY 168 therapy. One boom wee e righ' posterior oblique IRPO) the other boom used USED IN THERAPY wee a left enterior oblique (LAO). The block that wee used wee a bett boom DOSE PLANNING block. This resulted in the wrong sees being treeted with the RPO beam. The right shoulder eroe wee supposed to be treeted. however, the right lung eroe wee treated. The right fung eree of the pattent received en opproximate does of 100 cGy. The Ucensee bee euepended the technolog8st involved pending further review.

The Licensee formed e sub-committee to perform o thorough investigation into thle event. The Ucenees immediately suspended use of the cobelt unit pending the outcome of the investigation. The sub-commit'ee determined the cause of this event was due to the feiture to follow written institutional policies and procedures. Also, the therapiste rendering treMment feited to follow the QMP guidelinee end verify some of the treatment raremeters. The sub-committee eeked all personnel in the department to meet and develop precedures that will:(1) Reduce the likelihood of recurrence of the event. and (2) Improve the INCORRECT DATA 92- Y 3 TELETHERAPY THE UCENSEE REPORTED A TELETHERAPY MISADMINISTRATION USED IN THERAPY 266 tNVOLVING A DOSE GREATER THAN PRESCRI9ED.

DOSE PLANNfNG A PATIENT WAS PRESCRIBED A DOSE OF 4,140 RAD FOR PALUATIVE TREATMENT OF LUNG CANCER. THE PATIENT WAS SUPPOSED TO RECEIVE FRACTIONS OF 100 RAD / DAY.THE DOSIMETRIST MADE AN ERROR AND SELECTED THE WRONG REGIMEN OF 300 RAD / DAY. FIVE TREATMENTS -

WERE ADMINISTERED DEUVERING A DOSE OF 1500 RAD INSTEAD OF THE INTENDED 900 RAD. THIS MtSADMINISTRATION CONSTITUTED AN ERROR OF 67% IN ONE WEEK.

ON THE PATIENT'S PERSONAL PHYSICIAN'S ADVICE. THE PATIENT WAS NOT NOTIFIED.

PATIENT NOT 92- Y 3 TELETHERAPY DOSE TO THE WRONG SITE. A PATIENT WITH CANCER HAD RECEIVED A POSITIONED PROPERLY 069 THER APEUTIC RADIATION DOSE TO THE INCORRECT SIDE OF THE CHEST AREA. THE PATIENT WAS SCHEDULED TO RECEIVE 28 DAILY TREATMENTS OF 180 RADS EACH TO THE RIGHT COLLAR BONE AREA AND 90 RADS EACH TO TANGENTIAL AREAS OF THE RIGHT BREAST.

THE RADIATION THERAPISTS ERRONEOUSLY TREATED THE LEFT COLLAR p"'E AREA INSTEAD OF THE INTERNDED TREATMENT AREA ON THE 7 ~ iT, ON 2/24/92. THE THERAPISTS DICOVERED THE ERROR AS THEY

.fPARED TO TREAT THE TWO TANGENTIAL AREAS OF THE LEFT BREAST. THE RADIATION THERAPY TECHNOLOGISTS STATED THAT THE ERROR OCCURRED BECAUSE THEY CONFUSED A LEVEUNG TATTOO ON THE LEFT COLLAR BONE AREA WITH THE TREATMENT TATTOO ON THE RIGHT COLLAR BONE AREA. THEY ALSO DID NOT FOLLOW THE -

PROCEDURES FOR CONFIRMING THE ACCURACY OF THE TREATMENT SITn!

FOR AGREEMENT WITH THE PRESCRISED TREATMENT SITE AS SPECIFIED IN THE UCENSEE'S QMP.

4 Pege 36

_ __ _ ___._._..________..._.___..__.._.m..________.___.________________..m _ _ _ _ _ _ _ _ _ _ . __ - __ - -- r ...W

MISADMINISTRATIONS 2/13D7 ,

• =* '

EA Z -- -- a amt Leva NW - ==_M AmmiMAcf I

~ alNG 94- Y 3 LINEAR PATIENT WAS INITIALLY PRESCRIBED 5000 RADS OF CO-so EXPOSURE IN TWENTY-FIVE WEEKLY TREATMENTS ON 02/28/94. ON 03/01/94, THE PHYSICIAN'S REQUEST OSS ACCELERATOR MISUNDERSTOOD PHYSICIAN CHANGED THE PRESCR7 TION TO 4000 RADS OF CO-00 AND 1000 RADS OF LINEAR ACCELERATOR (LINAC) EXPOSURE. THE TOTAL DOSE RECEIVED BY THE PATIENT IS ESSENTIALLY IDENTICAL TO THE PRESCRIPTION, HOWEVER, THE CO-80 DOSE OF 9000 RADS EXCEEDED -

THE PRESCRl8ED DOSE OF 4000 RADS BY APPROXIMATELY 22%. THE MISADMINISTRATION WAS DISCOVERED BY A TELETHERAPY PHYSICIST ON 04/18/94. AN INVESTIGATION INTO THE PRESCRIPTICM CHANGE AND -

CHANGE IMPLEMENTATION PROCEDURES IS ONGOING.

THE PATIENT WAS NOT NOTIFIED OF THE MISADMINISTRATION. NO ADVERSE AFFECTS ARE ANTICIPATED.

INCORRECT DATA 94- Y a TELETHERAPY The licensee reported a teletherapy misedministration involving a dose greater USED IN THERAPY 126 then prescribed.

DOSE PLANNING The misedmirdstration occurred during the radiation treatment of a patient's les using a Co-90 toietherapy unit beginning March 18,1994 and ending April 5, 1994. The prescribed dose wee 3.000 red (3,000 cGy)in a series of 5 treatmente. Due to en error in the treatment parameters, the does per treatment wee 32% ebove the intended dose for the first 15 treetmente. The total dosege wee 3,965 rede (3,965 cGy). The error wee discovered efter the first series of 15 treatmente had been completed. The authorized user physician revised the written directive to reflect the octuel dosage and '

discontinued the treatment without the second eerlos. The NRC Inspector determined however that the calculeted weekly adminietored dose wee 32%

ebove the prescribed dose wNch coneltutes a misedministration.

SS- Y 3 TELETHERAPY DURING AN NRC INSPECTION, IT WAS DISCOVERED THAT A TELETHERAPY QUALITY MANAGEMENT PLAN 217 MIS ADMINISTRATION INVOLVING A DOSE GREATER THAN PRESCRIOED NOT FOLLOWED HAD OCCURRED.

THE PHYSICIAN INITIALLY NOTED THAT SHE INTENDED TO ADMINISTER I 2,000 CGY FOR A TOTAL TUMOR DOSE: THE LICENSEE CONTENDED THIS WAS LATER MODIFIED, THROUGH REVISIONS TO THE WRITTEN DIRECTIVES, TO A TOTAL TUMOR DOSE OF 2.200 CGY.

THE TREATMENT RECORD INDICATES THAT THE PHYSICIAN MODIFIED THE DIRECTIVES TO REQUIRE A TOTAL OF 11 TREATMENT FRACTIONS RATHER THAN 10 AS WAS INDICATED IN THE INITIAL WRITTEN DIRECTIVES.

ALTHOUGH THE INITIAL WRITTEN DIRECTIVE INDICATED A TOTAL DOSE OF 2,000 CGY, THE REVISIONS WERE APPARENTLY WRITTEN TO INDICATE THE FRACTIONAL DOSES TO BE ADMINISTERED TO EACH TREATMENT FIELD. THESE VALUES DID NOT CORRESPOND TO THE TUMOR DOSE BECAUSE THEY DID NOT ACCOUNT FOR DOSE CONTR19UT10NS FROM BOTH OPPOSING TREATMENT PORTS.

Page 37

MISADMINISTRATIONS 2/1307 PR&,. DURE ABSTRACT e__ N l EA h- - ~ ~ T SEV 1.EVEL TELETHERAPY THE LICENSEE REPORTED A TELETHERAPY MtSADMINISTRATION LOSS OF 92- Y 3 INVOLVING A DOSE GREATER THAN PRESCRIBED. ADMINtSTRATIVE 127 CONTROL A PATIENT WAS SCHEDULED TO RECEIVE ONE 120 RADS FRACTION TWICE A DAY. DUE TO A CALCULATION ERROR THE PATIENT RECEIVED 240 RADS TWICE A DAY FOR 11 DAYS.

THE TOTAL DOSE RECEIVED WAS 5200 RADS; THE INTENDED DOSE WAS 2640 RADS FOR THAT PORTION OF THE T'4ERAPY.

THE PATIENT DEVELOPED REDDENING OF THE SKIN ON THE NECK.

TELETHERAPY The licensee reported a teletherapy rnisedministration involving a dose greater INCORRECT DATA 94- Y 3 then prescribed. Two Co-60 miesdministrations occurred because of a USED IN THERAPY 107 discrepency between the written directives and the delivered dose. Eoch of DOSE PLANN?NG the two petients wee to receive 200 rods e day for five doya et a depth of 0.5 cm for a total of 1000 rede. Insteed, one patient received 1300 rede end the other patient received 1322 rede et e depth of 5 cm. The Ucenees believes l there will be no hennful effects. The Ucensee hee required authorized users f to write out eil field changes and boost fielde se completely se are the original directives. No one is permitted to work with the teletherapy unit without first Going through training.

The misedministrations occurred because the written directive wee uncieer et to the depth of treatment and the number of fractions.

TELETHERAPY The licensee reported a teletherapy misedministration involving dose to the INCORRECT DATA 94- Y 3 wrong ette. USED IN THERAPY 102 DOSE PLANNING A patient wee exposed to e non-prescribed Co-60 dose during whole brein radiotherapy. Technologist erroneously placed the Co 60 gentryin 15-degree enterior oblique position insteed of the prescribed 15-degree poeterior oblique poetion. In the original written directive, the patient weg to receive a total dose of 3000 rede in ten fractione in three weeks. The first fraction treeted the whole brain with 300 rede. After the first frectional treatment, Licensee's euthorized user changed the written directives so that the remaining 2-10 fractional treatments would treet the whole brain and right eye with 300 red / fraction. After administering the second fractional treatment, the technologist roeiired the angle wee incorrect. Physicien end patient have been notified. No adverse effecte enticipeted.

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__.____.__.____m_____ _ . . _ _ _ _ . _ . _ _ _ _ _ _ _ . . _ _ _ . _ _ . _ _ _ _ _ . _ _ . _ _ _ _ . _ _ _ . _ _ . _ _ _ m_____._ _ _ _ ______ _ __m_.

o e

MISADMINISTRATIONS 2/13197 PROCEDURE ABSTRACT l CAniar sa Eg,g._ w ra egytmmt TELETHERAPY THE LICENSEE REPORTED A TELETHERAPY MISADMINISTRATION ERROR IN EQUtPMENT INVOLVING A DOSE GREATER THAN PRESCRIBED. SELECTION A MAP E PATIENT RECEIVED TELETHERAPY TREATMENTS TO THE LARYNX.

OF THE 35 FRACTIONS 4 CONSECUTIVE FRACTIONS WERE DEUVERED WITHOUT THE REQUIRED USE OF A WEDGF SO THESE DOSES WERE 300 RADS PER FRACTION INSTEAD OF THE PRESCRIBED 200 RADS.

THE WEEKLY PRESCRIBED DOSE WAS 1000 RADS BUT THE RECEIVED DOSE FOR THAT WEEK WAS 1300 RADS.

THE PHYSICIAN AND PATIENT WERE BOTH NOTIRED. NO ADVERSE MEDICAL EFFECTS WERE EXPECTED.

TELETHERAPY THE LICENSEE REPORTED A TELETHERAPY MIS ADM NISTRATION INCORRECT DATA 92- Y &

INVOLVING A DOSE GREATER THAN PRESCRIBED. USED IN THERAPY 070 DOSE PLANNING DUE TO AN ERROR IN TREATMENT CALCULATIONS. A PATIENT RECEtVED 340 RAD INSTEAD OF THE PRESCRIBED 200 RAD FOR THE FIRST S FRACTIONS OF A 20 FRACTION TREATMENT. THE FOLLOWING FRACTIONS WERE MODIFIED TO ACCOUNT FOR THE EXCESS DOSE.

, REGION l!! CONOUCTED A SPECIAL INSPECTION. THE REFERRING PHYSICIAN AND THE PATIENT WERE NOTIFIED OF THE MISADMINISTRATION.

TELETHERAPY THE LICENSEE REPORTED A TELETHERAPY MISADMINISTRATION INCORRECT DATA 93- Y 3 INVOLVING DOSE TO THE WRONG SITE. USED IN THERAPY 132 A PATIENT WAS SCHEDULED TO RECE!VE A TOTAL DOSE OF 3,000 RAD DOSE PLANNING TO THE BRAIN DELIVERED IN 10 FRACTIONS.

THE DOSIMETRIST CALCULATED THE DOSE BASED ON A TUMOR DEPTH OF 16 CM RATHER THAN THE CORRECT DEPTH OF 8 CM. THIS ERROR RESULTED IN THE PATIENT RECEIVING DOSE TO THE WRONG AREA OF THE BRAIN AND S10 RAD PER TREATMENT RATHER THAN THE INTENDED 300 -

RAD.

THE THERAPY PHYSICIST DISCOVERED THE ERROR ON 11/12/92 DURING A REVIEW OF PATIENT DOSE CALCULATIONS. THE PATIENT AT THis POINT HAD RECEIVED 5 FRACTIONS FOR A TOTAL DOSE OF 2.550 RAD.THE PATIENT'S PHYSICIAN DECIDED NOT TO CONTINUE TREATMENT AT THAT POINT.

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