ML20133B017

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Forwards Routine & Reactive Insp Guidance for 10CFR35.32 & 10CFR35.33, Quality Mgt Programs & Notifications,Repts & Records of Misadministration
ML20133B017
Person / Time
Issue date: 12/23/1996
From: Cool D
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Hehl C, Mallett B, Pederson C
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
References
NUDOCS 9701020233
Download: ML20133B017 (2)
v • d • e


Text

D:c:mb:r 23, 1996 MEMORANDUM T0: Those en Attach:d List FROM,: Donald A. Cool, Director Division of Industrial and g i e sig *nedty ,d __.,

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Medical Nuclear Safety, NMSS b

SUBJECT:

ROUTINE AND REACTIVE INSPECTION GUIDANCE FOR 10 CFR 35.32 AND 35.33, " QUALITY MANAGEMENT PROGRAMS" AND NOTIFICATIONS, REPORTS, AND RECORDS OF MISADMINISTRATIONS" On August 1, 1996, Temporary Instruction (TI) 2800/025, " Quality Management Program and Misadministration Rule, Revision 1," expired. As a result, the Division of Industrial and Medical Nuclear Safety (IMNS) provided the regions interim guidance in a memorardum dated August 1, 1996, (Attachment 1). Since then, IMNS has developed two sets of guidance: (1) "QM Inspection Procedures:

New and Regularly Scheduled Inspections," (Attachment 2), and (2) " Reactive Inspections of Quality Management Programs," (Attachment 3).

Begin using these draft inspection procedures immediately for inspection of both regularly scheduled and reactive inspections. Comments received from the regions within 60-days from the date of this memorandum will be considered for incorporation into the final guidance.

The procedure for inspection of new and regularly scheduled inspections will ultimately be provided to the working group revising Inspection Procedures (IP) 87100 for inclusion, and the procedure for reactive inspections will become a part of IP 87103. Manual Chapter 2800 was reviewed, and no changes were needed to accommodate these new procedures.

Attachments: 1. Interim Guidance dated 8/1/96

2. "QM Inspection Procedures:

New and Regularly Scheduled Inspections"

3. " Reactive Inspections of Quality Management Programs" CONTACT: Sally L. Merchant, NMSS (301) 415-7874

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DISTRIBUTION:

k JRicci, TTC IMNS Central File IMAB r/f NRC File Center RFonner,0GC NMSS r/f REGCHFS REGSL Public Doc Rm PCVacca HP Data,IM0B Dhcr RBangart, OSP MLMcLean, RIV EUllrich, RI

" Attached" Guidance stored at G:87100.0M C - COVER E = COVER & Attachment N = NO COPY Memo: G:\IMNS5476. SLM _

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'k -MEMORANDUM T0: THOSE ON ATTACHED LIST DATE: December 23, 1996

SUBJECT:

ROUTINE AND REACTIVE INSPECTION GUIDANCE FOR 10 CFR 35.32 AND 35.33, " QUALITY MANAGEMENT PROGRAMS" AND NOTIFICATIONS, REPORTS, AND RECORDS OF MISADMINISTRATIONS" Attached List:

Charles W. Hehl, Director Division of Nuclear Materials Safety, RI Bruce S. Mallet, Director Division of Nuclear Materials Safety, RII 4

Cynthia D. Pederson, Director Division of Nuclear Materials Safety, RIII Ross A. Scarano, Director Division of Nuclear Materials Safety, RIV James Lieberman, Director Office of Enforcement i

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, UNITED STATES i

! g g NUCLEAR REGULATORY COMMISSION R WASHINGTON, D.C. 30006-00M o

'% * ** * * $ August 1, 1996 MEMORANDUM TO: Those on Attached List , 3 FRON: Donald A. Cool, Directo h A, 47

Division of Industrial and h - --

l Medical Nuclear Safety, NMSS

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SUBJECT:

IMPLEMENTATION OF 10 CFR 35.32 and 33

" QUALITY MANAGEMENT AND MISADMINISTRATIONS" l On August 1, 1996, Temporary Instruction (TI) 2800/025, " Quality Management i Program and Misadministration Rule, Revision 1," expires. The TI implemented

the inspection procedures for the rule, and established the areas of

! inspection and procedures for determining compliance with the performance-based portions of the rule. This memorandum provides guidance for inspection of the requirements set forth in 10 CFR 35.32, " Quality Management program,  ;

and 35.33, " Notifications, reports, and records of misadministration," after l

! the TI expires, j After August 1,1996, inspectors will no longer complete the QM field notes  !

i (Attachment A of the TI) during routine inspections (for reactive inspections, l see instructions in item 2 below). Inspectors are required to sube!t copies of the QM field notes, completed before August 1, by August 9,1996. This information is needed to complete the data collection so that the Headquarters staff may begin the analysis of the TI findings.

I The staff is revising Manual Chapter 2800 and Inspection Procedure 87100 to include field notes for both routine and reactive inspections of quaP ty i management programs. In the interim, inspectors should implement the

following procedures:

i 1. For new and routine insnections, inspectors are instructed to implement

a more performance based approach to the review of licensees' activities i intended to comply with 10 CFR 35.32. In an unobtrusive manner, i inspectors should verify that
a, quality management program (QMP) i commensurate with the licensee's activities is being implemented; all modalities of use under the license are included; the licensee is j

conducting a review of the QM program at least annually; and the records of the review are maintained in an auditable form for 3 years. If i during the an=al review the licensee identified recordable events, assure that an evaluation was performed and that any appropriate corrective actions were taken. This evaluation should be completed as j part of the normal inspection of a medical use program. The applicable sections of the existing QM field notes are to be used to verify the i

four key elements previously discussed as part of the performance 4

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! CONTACT: s' ally L. Merchant, NMSS

' (301) 415-7874 i

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2 oriented inspection until the new field notes are available. The extent of documentation required should closely follow the performance oriented inspection.

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2. For re:ctive inspections, inspectors should follow the guidance provided in Management Directive 8.10, "NRC Medical Event Assessment Progras,"

and, for the modality involved with the event, e.g., f odine therapy or high dose rate afterloading brachytherapy, etc (1) review the licensee's written QMP; (2) follow the existing guidance in TI 2800/025 to enswe that the licensee's QMP has been implemented; and, (3) review the findings of the annual reviews for the last 3 years. Only the modality involved should be evaluated as part of this inspection.

3. For misadministrations, (1) follow the procedure for reactive inspections (above), and (2) ensure that the licensee has complied with the reporting requirements described in 10 CFR 35.33, " Notifications, reports, and records of misadministrations."

In addition to reviewing QMPs during event investigations, QMPs submitted with new license applications should continue to be reviewed following the guidance provided in Policy and Guidance Directive PG 3-15.

During the past two years, the inspectors have devoted considerable time and effort to completing the extensive field notes associated with the TI. This information will be analyzed to determine the manner and degree of success in which licensees implemented the QM rule. This information will be of substantial value in informing the Commission of the outcome of the rule and in making recommendations for future corsideration.

Attachment:

PG 3-15 DISTRIBUTION:

JRicci, TTC IMNS Central File .IN48 r/f 4 NRC File Center RFonner,0GC NMSS r/f REGCHFS REGSL Public Doc Rm PCVacca HP Data,IM06 RBangart, OSP MLMcLean, RIV EU11 rich, RI C = C0VER E = C0VER & Att/4hment N = NO COPY G:\ Implement. SLM 0FC iMAB [ M, f; m IMQE)

NAME St@ N ant br Miccone muu aab i-0FC DD/IMS . IXll MS k f NAME F[ombs M[dCMN DATE ./h/ /96 f/ /b

2 M40RANDUM TO: THOSE ON ATTACHED LIST DATE: July 12, 1996

SUBJECT:

IMPLEMENTATION OF 10 CFR 35.32 and 33 " QUALITY MANAGEMENT AND MISADMINISTRATIONS" Attached List:

James Lieberman, Director Office of Enforcement Charles W. Nehl, Director Division of Nuclear Materials Safety, RI Bruce S. Mallet, Director Division of Nuclear Materials Safety, RII Cynthia D. Pederson, Director i Division of Nuclear Materials Safety, RIII l 1

Ross A. Scarano, Director l Division of Nuclear Materials Safety, RIV l

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l Attachment 2

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QM INSPECTION PROCEDURES New and Regularly Scheduled Inspections 3

l Quality Manaaement Procram (0MP)

For routine inspections of applicable facilities, inspectors are instructed to implement a performance based approach to the review of licensees' activities intended to comply with 10 CFR 35.32. Inspectors should observe and interview individuals as they perform applicable duties to ensure that the QMP, as implemented, provides high confidence that byproduct material, or radiation from byprcJuct material, will be administered as directed by the authorized user.

General Guidance:

a. This guidance applies to those medical licensees who are authorized to 4

possess and use byproduct material for applications involving the following modalities:

1. Quantities greater than 30 microcuries of either sod'um iodide I-125' or I-131;
2. Therapeutic administrations of a radiopharmaceutical, other than sodium iodide I-125 or I-131; i 3. Brachytherapy, including High-Dose-Rate Remote Afterloading and Strontium-90 eye applicators;
4. Teletherapy; and
5. Gamma Stereotactic Radiosurgery,
b. The intent of the inspection is to determine if the licensee effectively i implements policies and procedures designed to meet the objectives and requirements in 10 CFR 35.32, and the notification, reporting, and record keeping requirements in 35.33.

The inspection should include consideration of the licensee's

implementation of a continuous improvement process in the QMP. This review should include (1) the monitoring process - has the licensee been looking for unintended deviations (e.g., errors, mistakes, or omissions) that could have led to a misadministration; (2) the identification process - has the licensee found unintended deviations (e.g., through j reviews or representative sampling) that could have led to a misadministration; (3) the evaluation process - has the licensee made assessments of the unintended deviations (e.g., what, when, how, or why  ;

the events occurred, including an analysis of any trends and patterns) 4 that could have led to a misadministration; (4) the corrective action process - has the licensee implemented an action plan to fix the unintended deviations that, if not addressed, could have led to a j misadministration; and (5) the preventive measures process - has the i licensee instituted actions to prevent recurrence of the unintended deviations (e.g., modifications to the policies or procedures) that could have precluded the likelihood of a misadministration?

Review of all records associated with the licensees' QMP is not necessary I unless: (1) there is reason to suspect that the QMP has not been appropriately implemented; (2) all modalities requiring a QMP have not been addressed; (3) a recordable event occurred, and the licensee did not identify, evaluate and institute corrective actions; or, (4) an unreported or previously unidentified misadministration was identified during the inspection.

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. a. Scope of OME Verify that a written QMP, commensurate with the

licensee's activities, has been established and implemented. It is

not necessary to perform an in-depth review of the written program i

unless this is a new license or modality (e.g., brachytherapy has been added requiring a QMP). However, the inspector should verify that the QMP includes procedures to address each of the applicable objectives set forth in 10 CFR 35.32. Ensure that all applicable modalities of use identified on the license are included. The QMP i need not be maintained in totality in one location, but may be j segmented in various areas of use (e.g., radiopharmaceutical j therapy, brachytherapy, teletherapy,etc.).

b. Annual Review of OMP The frequency of the review may vary.

However,10 CFR 35.32(b)(1) requires that a review of the QMP be performed at intervals of no greater than 12 months. Verify that a ,

review of the QMP has been performed, at least, at this interval. l Ensure that the review includes: (1) a representative sample of  !

patient (and human research) administrations; (2) all recordable events; and, (3) all misadministrations. Ensure that the reviews were evaluated to determine the effectiveness of the QMP, and if l required, modifications to the QMP were made and implemented. l

c. Records Verify that records of each annual review, including each written directive, a record of each administered dose or dosage, and the evaluations and findings, are maintained, in an auditable form, for three years. -
d. For recordable events if the recordable event was self-identified l (identified by the licensee), verify that an evaluation was performed within 30 days after discovery of the event, and note the ,

corrective actions that were taken. If no or inadequate corrective i actions were taken, determine whether the lack of corrective action caused the license to be in non-compliance with regulatory .

requirements. If a recordable event is identified by the inspector, l bring the event to the attention of the licensee. The licensee has 30 days in which to evaluate the event, and take any necessary corrective action.

e. For misadministrations: if during an inspection, a previously unidentified misadministration is identified by the inspector: (1) follow the procedure for reactive inspections (Attachment 3), and (2) remind the licensee of the need to comply with the reporting requirements described in 10 CFR 35.33, " Notifications, reports, and records of misadministrations."
f. For all reactive inspections, inspectors ::hould follow the guidance provided in Management Directive 8.10, "NRC Medical Event Assessment Program," and follow the procedure for reactive inspections (Attachment 3).

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l Issue Date: 12/ /96 l

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(, QM FIELD NOTES New and Regularly Scheduled Inspections cuality Manaaement A. Scope of Quality Manaaement Proaram (OMP) 1 i (1) Written QMP commensurate with the licensee's l activities established and implemented. ()Y()N (2) All modalities of use under the license  !

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included ()Y()N (3) QMP includes procedures to address each of the applicable objectives:

(a) OBJECTIVE 1 Written directives prepared for each patient

[35.32(a)(1)] ()Y()N (b) OBJECTIVE 2 Licensee uses more than one method to verify patient's identity [35.32(a)(2)] ()Y()N i i

(c) OBJECTIVE 3 Procedures implemented i to verify final plans of treatment and related calculations in accordance with written directives [35.32(a)(3)] ()Y()N (not applicable to radiopharmaceutical therapy including sodium iodides)  ;

(d) OBJECTIVE 4 Procedures implemented to verify, prior to administration, specific details in accordance with written directive [35.32(a)(4)] ()Y()N (e) QRJECTIVE 5 Procedures implemented to ensure unintended deviations identified, evaluated, and corrective action taken (35.32(a)(5)] ()Y()N B. Annual Review of OMP The frequency of the review may vary.

However, 10 CFR 35.32(b)(1) requires that:

1. QMP reviewed within 12 month intervals ()Y()N Review includes:

(a) Representative sample of patient (and human research) administrations ()Y()N '

l l (b) All recordable events ()Y()N l (c) All misadministrations ()Y()N 12/ /96

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2. Effectivenesslof the QMP was evaluated ()Y()N
3. If needed, modifications to the QMP were made and implemented ()Y()N C. Recordi:

Records of each annual review, including:

written directive, record of each administered dose or dosage, and evaluations and findings, maintained, in auditable form, for three years. ()Y()N D. Recordable Events and Misadministration:

(1) Recordable event (s) self-identified since the last inspection [35.32(c), 35.2] ()Y()N Dates of events:

(2) Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N (3) If no, was there a poter.tial violation of NRC regulations ()Y()N (4) Recordable events identified by inspector -()Y()N (5) Licensee identified misadministration (s) since the last inspection ()Y()N (6) If response is yes to item D.5., licensee met the requirements of 10 CFR 35.33 ()Y()N (7) Inspector identified misadministration (s) since the last inspection (not previously identified by the licensee ()Y()N Issue Date: 12/ /96

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INSPECTION REQUIREMENTS:

The following requirements should be completed for reactive inspections of medical l licensees who are required to implement a Quality Management Program (QMP). The l

inspector should determine licensee complianca with 10 CFR 35.32 and 35.33, as applicable. For any investigation that includes a medical event, the inspector must iirst follow NRC Management Directive 8.10, "NRC Medical Assessment Program" to ensure that medical events are reviewed in a manner that is timely, objective, systematic, and technically sound; that factual information pertaining to the events is documented; and that probable causes are documented.

Inspectors are reminded that an event evaluation is not complete without an evaluation of the root cause. In addition, if the licensee is not in compliance, then the region should take appropriate enforcement action.

The regional inspector should complete the "QM Field Notes" given in Attachment A, as applicable.

Ggneral Guidance:

a. This guidance applies to those medical licensees who are authorized to possess and use byproduct material for applications involving the following modalities:
1. Quantities greater than 30 microcuries of either sodium iodide I-125  :

or 1-131;

2. Therapeutic administrations of a radiopharmaceutical, other than sodium iodide I-125 or I-131;
3. Brachytherapy, including High-Dose-Rate Remote Afterloading and Strontium-90 eye applicators;
4. Teletherapy; and S. Gamma Stereotactic Radiosurgery.
b. The intent of the inspection is to determine if the licensee effectively implements policies and procedures designed to meet the objectives and requirements in 10 CFR 35.32, and the notification, reporting, and record keeping requirements in 35.33. In addition, a determination should be made between the caliber and implementation of the licensee's QM program in relation to the misadministration event. The emphasis during the reactive inspection will be on the analysis of the sequence of events and the conditions that existed at the time these events occurred. The analysis should lead to the determination of contributing factors and root causes, and to the frmulation of corrective actions to prevent recurrence.

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c. Review the licensee's policies and procedures for instruction of supervised individuals in the QMP. Verify that the staff training has occurred.

Inspectors should interview individuals present. If an apparent failure in the QMP is identified, determine whether the failure could be attributed to poor, inadequate, or no instruction in the area of the failure. Determine i

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REACTIVE INSPECTION OF QMP 2 if the failure is isolated, broad or i m 1ves other individuals.

Additionally, determine if the failure represents an implementation problem ,

involving only specific areas of the department's QMP, or general aspects of l the institution's entire QMP. I

d. If the subject event is a misadministration, ensure that the licensee has complied with appropriate notification, reports, and records as required in 10 CFx 35.33.

Description:

The QM Field Notes for the QMP are provided in the form of a reactive inspection cover document and a series of modules, each containing a checklist for a specific l modality of use. As part of the preparation for inspection, the inspector should read the licensee's submitted QMP and Eny modifications, and assemble available details of the misadministration or other event. The inspector should enter the available information on the cover document as part of the inspection preparation.

The inspector should be familiar with the licensees QMP in order to compare the l written program with the program as implemented. The inspector should not attempt I to determine that the program, as written, is acceptable, but rather should determine as a result of the inspection, that the licensee's program as implemented, meets the objectives of 10 CFR 35.32.

Since all information needed to complete the field notes on notifications, reports, and records of misadministration may not be available at the time of the inspection, the inspector should provide the information that is known, and complete the notes as information becomes available. l Specific Guidance: '

l. Although only the modality for which there was an incident /

misadministration need be inspected, confirm that the licensee has a written QMP(s) that specifically addresses each modality that is utilized by the licensee.

2. For all medical misadministrations, the inspector must follow the guidance provided in NRC Management Directive 8.10, "NRC Medical Assessment Program."
3. Confirm that the QMP includes written policies and procedures that require a written directive and program review.

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4. Interview supervised individuals (e.g., technologists, dosimetrists, physicists, or physicians) to determine if these individuals are familiar 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 i j daily activities that relate to the effective implementation of the QMP.

Instruction should be specific and appropriate to each individual's use of byproduct material as required by 10 CFR 35.25. Inspectors should document i the names and positions of all individuals who have not received training in the licensee's QMP.

Issue Date: 12/ /96

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j REArTTVE INSPECTION OF QMP 3  !

Additionally, document the reasons given for the failure to instruct as stated by the individual, the radiation safety officer, and the supervising authorized user.

5. Confirm that the licensee has selected and reviewed a representative sample l of patient administrations within each 12 month period. The licensee may use any representative sampling methodology to confirm that there are no previously unidentified recordable events or misadministrations. Regulatory Guide 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. j l
6. Select a random sample of patient administrations to review in each modality using the following multi-step process:
a. Request licensees to provide the approximate total number of administrations requiring a written directive since the last inspection. In order to eliminate any bias in the sample, the administrations to be reviewed should be selected randomly. Document the total number of administrations for the subject modality.
b. A target sample is calculated, using the table supplied in Attachment A for each modality of use. If recordable events are identified in the review of the target sample for the specific modality, the target sample should be increased until the inspector believes he has assessed the extent of the problem.
7. Based on the review of the representative sample, confirm that the objectives for each modality have been met and that appropriate records were retained.
8. If the licensee failed to follow their QMP procedures, it may not necessarily ba a violation. The inspector should determine if the objective was met. The inspector should make the licensee aware of any identified weaknesses.
9. 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 redundant identification procedures.
10. Interview individuals (e.g., radiation oncologists or radiation therapists, neurosurgeons, clinical medical physicists, dosimetrists, or 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 l calculations are in accordance with the written directive. Confirm that the I

licensee performs checks of dose calculations. If the licensee uses l treatment planning or dose calculating computer programs for dose calculations, ask if the licensee has implemented procedures for acceptance testing before first use of the program for patient dose calculations.

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! REACTIVE INSPECTION OF QMP 4

11. Ask individuals to explain how the specific details of the administration are verified, before administering ngh radiation dose or radiopharmaceutical dosage, in order to be in accordance with the written directive.
12. 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 appropriate record. This documentation should serve as an additional check, after the administration has been performed, for the licensee to compare the prescribed with the administered dosage or dose.
13. 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, evaluate, 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 improtement 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 from beginning to end.

Describe any unintended deviations from the written directive that were identified by yourself.

15. Examine the licensee's reviews of their QMP, performed at intervals not to exceed 12 months, for each applicable modality. If the licensee identified any recordable events since the last inspection, the inspector should review the documentation of the licensee's evaluation of the event, and any corrective action that was taken by the licensee within 30 days after discovery.
16. 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.
17. Any identification by the licensee of misadministrations that were not subsequently reported to the NRC should be closely reviewed to determine the cause of the licensee's failure to report the misadministration.
18. For misadministrations that were reported, review documentation and/or copies of notifications, reports, and records.

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l Issue Date: 12/ /96

REACTIyEINSPECTIONOFQMP 5 STATISTICAL DATA REPORTING:

All direct reactive inspection effort expended should be charged to Inspection Procedure 87103.

Attachm_ tat:

A. Field Notes - Quality Management Program (QMP)

Modules:

A-1. Nal I-125 or I-131 > 30 Ci and  ;

Radiopharmaceutical Therapy 1 A-2. HDR Remote Afterloading Brachytherapy l A-3. Brachytherapy (Other than HDR)

A-4. Strontium-90 Eye Applicators l

A-5. Teletherapy A-6. Gamma Stereotactic Radiosurgery i

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. ATTACHMENT A OVAllTY MANAGEMENT PROGRAM (OMP_1 l pH FIELD NOTES FOR REACTIVE INSPECTIONS ,

1. GENERAL A. Facility name(s):

B. License number (s):

C. Docket number (s):  ;

D. Last inspection date(s):

E. Current inspection date(s):

-2. PREPARATION A. Be familiar with the submitted QMP and any modifications in preparation for inspection of the licensee's implemented QMP.

Familiarization should focus upon awareness of the submitted program in order to compare the written program with the program as implemented.

3. MODALITY:

A. Identify applicable modalities listed on the license:

liodule:

1. NaI I-125 or I-131 > 30 Ci and/or Therapeutic radiopharmaceutical other than Nal ()Y()N
2. High-Dose-Rate Remote Afterloading Brachytherapy ( ) Y ( ) N
3. All Other Brachytherapy ()Y()N
4. Strontium-90 eye applicator ()Y()N
5. Teletherapy ()Y()N
6. Gamma Stereotactic Radiosurgery ()Y()N B. Verify, through interview or observation, that a QMP has been implemented for each modality listed on the license. (only the modality where the event occurred need be inspected)

C. Identify modelity where the event (s) or misadministration (s) occurred, and attach appropriate inspection module (s):

4. Incident:

A. Misadministration ()Y()N B. Other incident ()Y()N If yes, briefly state what type:

C. Modality of event or misadministration:

i D. Therapeutic or diagnostic event:

l E. Date of event:

i i F. Date of discovery:

G. Identified by:

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. 2 H. Licensee implemented a QMP for this modality

[10 CFR 35.32) ()Y()N l 5. DESCRIPTION OF EVENT l A. Event classified as misadministration [35.2] ()Y()N If yes, which paragraph (s) under 35.2 best describes the event:

B. Describe sequence of events leading to misadministration. If not a misadministration, go to C:

C. Describe the event:

If necessary, attach separate sheet.

D. Number of patients or others exposed / overexposed:

E. Time period:

F. Occupational workers exposed ()Y()N If yes, describe:

G. Licensee evaluation and actions

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1. Calculated prescribed and actual doses ()Y()N Prescribed: Actual: _
2. Evaluated effect on patient ()Y()N
0. scribe:
3. Corrective actions taken to prevent recurrence ()Y()N Describe:
4. If licensee did not evaluate or take action, reason provided:

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6. EVALUATION OF THE EVENT i

A. Cause of event:

1. Human error ()Y()N
2. Patient intervention ()Y()N
3. Mechanical error ()Y()N

! a. Manufacturer / vendor:

l b. Serial number:

i c. Model number:

Issue Date: 12/ /96

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4. Computer software error ()Y()N
a. hanufacturer/ vendor:
b. Version:
c. Serial number:
d. Model number:

Remarks:

5. Failure to follow QMP ()Y()N \
a. Authorized user [35.32(a)) ()Y()N {
b. Supervised individual [35.32(a)(2)] ()Y()N  !

Describe:

i B. Root cause(s) and contributing factor (s) that led to this incident:

l. Identified by licensee:
2. Evaluated by inspector:
7. 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 notified ()Y()N Patient notified 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 l (Referring physician may inform the licensee either l that he will inform the patient; or that, based on  !

medical judgement, telling the patient would be harmful) l C. If patient was notified, patient also notified in writing within 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 i notified the responsible relative or guardian ()Y()N If no, licensee documented justification for decision ( ) Y ( ) N Remarks:

i

8. Attach appropriate module (e.g. Module 2 "HDR")

12/ /96

l

. MODULE Al RADI0 PHARMACEUTICAL THERAPY INCLUDING GREATER THAN 30 MICR0 CURIES NAI I-125 or I-131 l

1. SAMPLING (Inspector random sample of each radiopharmaceutical in use):

l Total Written Directives Minimum Taraet Samole 1

1 to-5 All 1 5 to 100 5 I

> 100 5% Total Target Number l Written Sample Reviewed  !

DlL.

1. Nal I-125 or I-131 > 30 C1
2. Radiopharmaceutical:

(Name:)

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 QMP.

2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
3. OBJECTIVES:

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 for sodium iodide:

required dosage information [35.2] ()Y()N C. Written directives radiopharmaceutical therapy: radiopharmaceutical, dosage, and route or administration [35.2] ()Y()N D 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

i

(

Nodule A-1 2 f

OBJECTIVE 2 A. Licensee uses more than one method tu verify the  ;

patient's identity [35.32(a)(2)] ()Y()N  :

OBJECTIVE 3 (Does not apply) l 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 i B. Procedures ga,y include: (not reuuirements) I

1. Dosage measured prior to administration ()Y()N
2. Parameters confirmed just prior to administration ()Y()N C. Record of administration maintained in auditable form (35.32(d)(2)] ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended  !

deviations are identified, evaluated, and 1 corrective action taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self identified since the i last inspection [35.32(c), 35.2] ()Y()N l Dates of events
2. Recordable events ider.tified by inspector

[35.32(c),35.2] ()Y()N

3. Misadministration resulted from the unintended deviation ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures mm include:

(not reouirements)

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 (35.33(a)) ()Y()N E. Licensee identified misadministrations that were not subsequently reported [35.33(a)] ()Y()N If ves. clarifv:

Issue Date: 12/ /96

Module A-1 3

4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP 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 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. icensee 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. Records of reviews including evaluation and findings j maintained for at least 3 years [35.32(b)(3)] ()Y()N ]

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

12/ /96

1

. MODULE A-2 HIGH-DOSE-RATE REMOTE AFTERLOADING 3RACHYTHERAPY r

1. SAMPLING (Inspector random sample of each modality)

Total Written Directives Minimum Taraet Sample 1 to 5 All 5 to 100 5

> 100 5% Total Target Number Written Sample Reviewed DlL.

1. HDR remote afterloading brachytherapy 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 QMP.
2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
3. OBJECTIVES:

l OBJECTIVE 1 A. A written directive (ordar for a specific patient, dated & sianed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for e;ch patient [35.32(a)(1)] ()Y()N '

l B. Written directives contain required information*

isotope, treatment site, & total dose [35.2] ()Y()N l l

C. Exceptions to written directives are documented l

[ footnote to 35.32(a)(1)] ( ) N/A

1. Written revisions ()Y()N
2. Oral revisions ()Y()N
3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

I

, Module A-2 2 OBJECTIVE 3 l

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

9. Procedures may include: (not requirements)
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 & applications) on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N
3. Other, describe:

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 reouirements)

1. Plan of treatment prepared in accordance with I the written directive ()Y()N
2. Person administering therapy treatment confirms the prescribed radioisotope, site, & total dose ( ) Y ( ) N l
3. Dwell times and positions verified prior to start of treatment ()Y()N
4. Verify source position using dummy sources or fixed geometry applicators prior to inserting sealed sources ()Y()N I
5. Prompt record by the authorized user, of the treatment parameters and signing or initialing patient's chart or appropriate record ()Y ()N
6. Other, describe:

C. Record of administration maintained in auditable form (35.32(d)(2)] ()Y()N Issue Date: 12/ /96

l*

Module A-2 3 91JECTIVE 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 i last inspection [35.32(c), 35.2] ()Y()N ,

Dates of events:

2. Recordable events identified by inspector j

[35.32(c),35.2] ()Y()N i 1

3. Misadministration resulted from the l unintended deviation ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures mity include: Inot reautrements)
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 l E. Licensee identified misadministrations that were not subsequently reported (If yes, also complete module 7)

[35.33(a)] ()Y()N

4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP 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 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 l misadministrations, not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N 12/ /96

,b ul.e A-2 4 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 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

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings.

Issue Date: 12/ /96

, MODULE A-3 BRACHYTHERAPY (OTHER THAN HDR REMOTE AFTERLOADING)

1. SAMPLING (Inspecto, random sample of each modality)

Total Written Directives Minimum Taraet Samole 1 to 5 All 5 to 100 5

> 100 5% Total Target Number Written Samole Reviewed D.i_

1. Brachytherapy 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 QMP.
2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s' Sund to be inadequately trained:
3. OBJECTIVES:

OBJECTIVE 1 A. A written directive (order for a specific patient, dated & sianed by authorized user (a.u.)

or physician u., der supervision of an a.u.) is l 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
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 l
2. Oral revisions ()Y()N l
3. Oral directives ()Y()N OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

). 7 Module. A-3 2

. OBJECTIVE 3 i

A. Procedures implemented to verify that final plans l

} of treatment and related calculations are in accordance with written directives [35.32(a)(3)]( ) Y ( ) N ,

. 9. Procedures bay include: (not reauirements) t ,

i 1. Check of dose calculations by an authorized user or a qualified person under supervision 2

of an authorized user who whenever possible did not make the original calculations ()Y()N ,

2. Performing acceptance testing (based on licensee's t specific needs and applications) on each treatment 1 planning or dose calculating computer program that could be used for dose calculations ()Y()N
3. Other, describe

)

OBJECTIVE 4 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 j B. Procedures may include
(not reauirements) ,
1. Plan of treatment prepared in accordance with the written directive ()Y()N i
2. Person administering treatment confirms prescribed
radioisotope, number of sources, source strengths, '

! treatment site, loading sequence, & total dose ()Y()N i

3. Verify source position using dummy sources or .

. fixed geometry applicators prior to inserting '

sealed sources ()Y()N i

4. Prompt record by the authorized user, of the

! number of sources, the actual loading sequence >

of sources implanted (location of each sealed i source in a tube, tandem, or cylinder) and  ;

! signing or initialing the patient's chart or j appropriate record ()Y()N l

5. Ensure that source.will not move or dislodge while implanted ()Y()N 4
6. Inspect implanted sources ()Y()N Frequency:

Inspecting individual trained ()Y()N Issue Date: 12/ /96

Module A-3 3

7. Other, describe:

C. Record of administration maintained in auditable form (35.32(d)(2)] ()Y()N 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 B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procetures p_ty 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 ccmplete 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

4. PERIODIC REVIEWS OF THE OM PROGRAM Il0 CFR 35.32(b)1 A. Review conducted of the QMP 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 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.

12/ /96

M,odgin A-3 4 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()3 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

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings.

l l

l l

l l

Issue Date: 12/ /96 l

1

[

1. SAMPLING (Inspector random sample of each modality)  ;

Total Written Directives Minimum Taraet Sample i

1 to 5 All 5 to 100 5

> 100 5% Total Target Number l

Written Sample Reviewed ,

L D.1L.  !

1. Strontium-90 Eye Applicator.

I 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 QMP.

2. SUPERVISION t

A. Supervised individual (s) instructed in QMp applicable l to the modality of use [35.25(a)(1)] ()Y()N  !

List individual (s) found to be inadequately trained. ,.

3. OBJECTIVES:

OBJECTIVE 1  ;

A. A written directive (order for a specific I patient, dated & sianed by authorized user (a.u.) l 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 '

i 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 OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity (35.32(a)(2)] ()Y()N l

l l

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

Modu,le.A-4 2 OBJECTIVE 3 i

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 an include: (not recuirements) i 1. Plan of treatment prepared in accordance

. with the written directive ()Y()N j 2. Assess quantity of material remaining after decay (decay chart or other method) ()Y()N

3. Other, describe:

J 4

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 j B. Procedures an include: (not reauirements)

J

1. Method used to time the administration ()Y()N
2. Person administering treatment confirms the prescribed site and the total dose, or source 1

strength and exposure time ()Y()N j 3. Other, describe:

C. Record of administration maintained in auditable

] form [35.32(d)(2)] ()Y()N OBJECTIVE 5 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:

i 2. Recordable events identified by inspector

! [35.32(c),35.2] ()Y()N 1

3. Misadministration resulted from the unintended j deviation (If yes, also complete module 7) ()Y()N 1

Issue Date: 12/ /96

Modu,1e, A-4 3 B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures p_ay 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

4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP ht intervals no greater l than 12 months [35.32(b)(1)] ()Y()N j 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 j i

The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 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 evants or misadministrations not previcesly 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 '(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 5 RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

12/ /96

  • "* MODULE A-5 TELETHERAPY
1. SAMPLING (Inspector random sample of each modality)

Total Written Directives Minimum Taraet Sample 1 to 5 All 5 to 100 5

> 100 5% Total Target Number Written Sample Reviewed DlL.

1. Strontium-90 Eye Applicator:

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 QMP.

2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
3. OBJECTIVES:

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 prepare for each patient (35.32(a)(1)] ()Y()N B. Written directives contain required information, total dose, dose per fraction, site, & overall 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 OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

Mo@lpA-5 2 J

OBJECTIVE 3 i 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 may include: (not reauirementsi

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 planning or dose calculating computer program that could be
used for dose calculations ()Y()N
3. Determining transmission factors for beam

, 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 l which the check should be performed) ()Y()N j i 6. Other, describe:

i R8JECTIVE 4 ,

A. Procedures implemented to verify, prior to a~

administration, that the specific details are in accordance with written directive [35.32(a)(4)] ( ) Y ( ) N

! B. Procedures mgy include:

(not recuirements)

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 4 and dose per fractio, ()Y()N i'
3. Other, describe:

i Issue Date: 12/ /96

j 1

l Modple A-5 3 l B. Record of each administration or fraction maintained in auditable form ()Y()N OBJECTIVE 5 l

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 B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures ply 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

4. PERIODIC REVIEWS OF THE OMP A. Review conducted of the QMP 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)(i)(ii)(iii)] ()Y()N 1

The licensee should utilize a representative sampling process which

- embodies a valid statistical sampling methodology. Regulatory Guide l 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.

12/ /96

1 t

4

.Mo.d.ule A-5 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 the evaluation of reviews, the licensee made l 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 l G. Records of reviews including the evaluation and findings  !

maintained for at least 3 years [35.32(b)(3)] ()Y()N l 1

Remarks: l i

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

1 1

1 Issue Date: 12/ /96

1 1

l* ,

I

, , , , MODULE A-6 GAMA STERE 0 TACTIC RADIOSURGERY i

I

1. SAMPLING (Inspector random sample of each modality)

Total Written Directives Minimum Taraet Sample

, I to 5 All 5 to 100 5

> 100 5% Total' Target Number Written Sample Reviewed h <

1. Gamma Stereotactic Radiosurgery )

i If two (2) or more written directives are incomplete or missing, the I review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.

2. SUPERVISION A. Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individual (s) found to be inadequately trained:
3. OBJECTIVES:

OBJECTIVE 1 .,

l 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 preparu 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 OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

i

l MODU,LgA-6 2  !

l OBJECTIVE 3 i A. Procedures implemented to verify that final plans i of treatment and related calculations are in '

accordance with written directives [35.32(a)(3)]( ) Y ( ) N 1  !

I l

i B. Procedures m_al a include: (not reauirements) i

1. Check of dose calculations by an authorized l user or a qualified person under supervision i

.I of an authorized user who whenever possible ,

j did not make the original calculations ()Y()N l

2. Performing acceptance testing (based on licensee's specific needs and applications)

~.

on each treatment planning or dose calculating computer program that could be used for dose calculations ()Y()N

3. Plan of treatment prepared in accordance with 5

the written directive ( ) Y.( ) N

4. Imaging and localization precision assured ()Y()N

< a. Stereotactic frame aligned and affixed ()Y()N

b. Imaging films correctly centered & labeled ( ) Y ( ) N S. Verify correct helmet & plug pattern selected ()Y()N l

1 j 6. Verify computer generated dose calculations were i

! correct 1/ entered into unit and that the computer l j print out shows correct data for the patient were used in the calculations ()Y()N 4 7. Other, describe:

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 may include: (not reouirements)
1. Check of treatment parameters 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 4

Issue Date: 12/ /96 1

M000LpA-6 3

2. Verify stereotactic frame coordinates on the patient's skull match the plan of treatment ()Y()N
3. Person 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
5. Other, describe:

B. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N 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 i

[35.32(c),35.2] ()Y()N l

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 recuirements)
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, aisu 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 12/ /96

A MODULE A-6 4

4. PERIODIC REVIEWS OF THLQMP A. Review conducted of the QMP 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)(i)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 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 D. Licensee evaluated each review to determine the effectiveness of the QMP [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 F. Modifications set 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

5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

Issue Date: 12/ /96

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