ML20126H990
| ML20126H990 | |
| Person / Time | |
|---|---|
| Issue date: | 03/23/1992 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Macrae J OFFICE OF MANAGEMENT & BUDGET |
| Shared Package | |
| ML19341F879 | List: |
| References | |
| FRN-57FR41376, RULE-PR-35 AC65-2-056, AC65-2-56, NUDOCS 9301060006 | |
| Download: ML20126H990 (24) | |
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NUCLEAR REGULATORY COMMISSION
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wAsHWGToN D.C.20035 March 23,1992 o f(,
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Mr. James B. MacRae, Jr.
Acting Administrator and Deputy Administrator Office of Information and Regulatory Affairs Cffice of Management and Budget 1725 17th Street, NW Washington, CC 20503
Dear Mr. MacRae:
I am responding to your letter, dated January 24, 1992, regardMg the Nuclear Regulatory Commission (NRC) Rule entitled "The Medical Use of Byproduct Material." We believe that the recordkeeping and reporting requirements contained in the final rule,10 CFR 35, " Quality Management (QM) Program and j
Misadministrations" (Enclosure 1), which became effective January 27, 1992, are both necessary for the rule's successful implementation and are fully consistent with the provisions of the Paperwork Reduction Act (PRA).
The Medical QM rule was developed to address concerns about insufficient supervision, deficient procedures or failure to follow procedures, inattention to detail, and inadequate training -- all of which have been found in one degree or another to be the cause of unnecessary and significant radiation.
exposure in past events (see Enclosure 2 for a more detailed description of the kinds of events that led to the promulgation of this rule).
It is events such as these that have convinced the Commission that it is important to have a framework in place that provides higher confidence that byproduct material (or radiation therefrom) will be administereo consistent with the directions of the authorized user. The Commission believes that this rule will result in enhanced safety in therapeutic and certain diagnostic administrations of byproduct material, where the radiological risk from mistakes can be significant.
By way of background, licensees of the NRC have been required since 1980 to report certain diagnostic and therapeutic misadministrations. Modifications to the existing reporting and recordkeeping requirements contained in the recent QM rule have actually raised the reporting threshold for certain categories of events, thereby reducing the number of required reports, in order to focus NRC's regulatory attention on those events of greatest radiological significance.
Information relating to the circumstances and causes of misadministrations obtained from the remaining reporting requirements may serve as the basis of information notices or bulletins that can alert other licensees to potential problems.
giogo06921216 35 57iR41376 PDR a
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- The principal new recordkeeping requirements associated with the QM rule include those for the written directive and development of a written QM These requirements promote comunication among the licensee's staff program.
regarding procedures and confirmation of the written directive. While providing a basis for inspection and enforcement, both.the reporting and recordkeeping requirements will also allow the NRC to fine-tune this regulation, as needed, after experience is gained with its implementation.
Based on a careful review of new information, licensee coments and a reanalysis of the number of HRC licensees required to have a QM program NRC acknowledges that the previous estimate of the reporting and recordkeeping burden may be higher tian that originally submitted to OMB. That estimate has been revised accordingly by HRC staff (Enclosure 3). For comparison with the total first year burden asserted by the Society of Nuclear Medicine (SNM)/American College of Nuclear Physicians (ACNP), NRC staff also recomputed the total first year burden.
Even using conservative assumptions, however, the increase in the reporting and recordkeeping burden would enlarge the estimated total burden by no more than a factor of three, which at $2.5 million would still be substantially lower (by two orders of magnitude) than the $381 Million estimated by the SNM and ACNP. A more complete response to the specific issues raised in your letter is provided in Enclosure 4 and a comparison of recordkeeping and reporting requirements for the existing Part 35, the proposed QM Rule and the final QM Rule is sumarized in Enclosure 5.
The impact of the QM Rule on medical care received substantial attention from the NRC during the development of this rule, when this and other issues were discussed in more than twenty public worksho)s (Enclosure 6). NRC staff has responded to an August 15, 1991 letter from tie Small Business Administration (Enclosure 7), and provided OMB with a sumary of our assessment of issues presented in the SNM/ACNP letter to OMB (Enclosure 8).
Also, the 79 public coment letters on this rulemaking from hospitals, professional associations and agreement states were carefully considered and a majority were incorporated in the development of the final rule. All of the concerns raised in your letter were expressed by representatives of the regulated comunity during the public coment period. The Comission considered all these coments in its determination of the need for the QM Rule. Consequently, the NRC does not believe that an additional meeting with the regulated comunity before implementation of the QM Rule will result in coments or concerns which have not already been fully ventilated in the numerous public meetings aircady conducted. However, the NRC will continue to interact with the regulated comunity to clarify HRC's position and to discuss issues as they arise curing irrplementation of the rule.
Lastly, the OMB concern with the rule's " utility" and OMB's assertion that NRC has not " clearly demonstrated that there is currently a significant problem requiring such a quality management program" reaches beyond the issue of whether the collection of information supports the objectives of the QM r91e.
It is our understanding that the PRA was not intended to be used for general substantive review of an independent agency's regulatory proposals. We nave stated the Comission's position that the recordkeeping and reporting 1
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requirements associated with the final QM rule are necessary for the rule's successful implementation so that NRC can carry out its mandate from Congress, namely to protect the health ~and safety of the public. We look forward to a timely and appropriate resolution of this issue.
Sincerely, Original SigW Bn Jam s M.Trf.at James M. Taylor Executive Director for Operations
Enclosures:
1 Federal Register Notice (56 FR 34104) 2.
Events Leading to Commission Determination of Need for QM Rulemaking 3.
Revised Estimated Burden 4.
Discussion of OMB Concerns' 5.
Comparison of Recordkeeping and Reporting Requirements for the Existing Part 35, the Proposed QM Rule and the-Final QM Rule 6.
Public Meetings and Workshops 7.
Response to Small Business Administration-8.
Remarks on the SNH/ACNP Letter
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i ENCLOSURE 1 Federal Register Notfce (56FR34104)
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BitLDSURE 2 Events Leading to Commission
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Determination of Need for QM Rulemaking i
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Inclosure 2 EVENTS LEADING TO COMMISSION DETERMINATION OF NEED FOR QM RULEMAKING August 1972 - The US Nuclear Regulatory Comnission's (NRC) predecessor, the.
Atomic Energy Commission (AEC) received a Government Accounting Office (GAO) report on AEC's program for fuel cycle and byproduct materials licensees.
According to that report, "From February 1961 through April 1972, 20 wrong doses or overdoses were brought to AEC's attention........ These cases involved human error. GA0 recognizes that, even with improved regulations, the possibility of such errors will not be eliminated.
Nevertheless GAO believes that, to strengthen AEC's controls over the use of radioactive materials, AEC should: tiefine in its medical liwnses or regulations the activities that may be delegated by physicians and those that may not; require physicians-to determine that technicians have been properly trained for their duties; and require that wrong doses or overdoses be reported to AEC."
March 1973 - AEC published a proposed rule, including a proposed misadmin-istration reporting requirement.
April 1976 - Riverside Hospital incident in which 400 patients were overdosed because of an improperly calibrated cobalt-60 teletherapy unit.
Some patients j
were overdosed by as much as 41%.
1977 - NRC received seven reports of misadministrations ranging from minor misadministrations to a more serious teletherapy overexposure.
May 1977. NRC proposed a teletherapy calibration requirement and a requirement that licensees report to the referring physician and the NRC if calibration measurements indicated that a delivered dose differed from a prescribed dose by more that 10%.
March 1978 - NRC published a proposed " Medical Policy Statement" in which NPC noted, "The purpose of a misadministration reporting requirement is to allow i
NRC to investigate the incident, evaluate the corrective at, tion taken by the licensee to minimize the chance.for recurrence, and, if other licensees can make the same errors, begin generic corrective action which would, as a minimum, inform other licensees of the potential problem."
July 1978 - NRC withdrew 1973 proposed rule and proposed instead that all l
licensees keep a record of each misadministration and, if it were a therr.py.
misadministration or a diagnostic misadministration that might cause "a l
clinically detectable adverse effect," report it to NRC, and also to the.
patient or guardian unless the referring physician was to intervene. Most i
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2 of the commenters characterized the rule as an unprecedented intrusion into medical practice that would cause undue alarm and unwarranted malpractice suits.
1978 - NRC received eleven reports of misadministrations, one of them a serious misadministration of four iridium-192 seeds that were left in a patient.
January 1979 - NRC published final rule on calibration of teletM.rapy units.
January 1979 - GA0 report stated that "... requiring medical licensees to report misadministrations to NRC is not an intrusion into medical practice.
This is clearly consistent with NRC regulatory responsibil't.ies and a necessary part of an effective nuclear medicine regulatory program W4thout this kind of feedback on incidents affecting the public health and safety, the NRC cannot be sure it is adequately regulating the possession and uve of nuclear materials in medical practice."
February 1979 - NRC published final policy st-r.eent," Regulation of the Medical Uses of Radioisotopes", to inform the puolic of the Commission's general intention regarding the regulation cf the medical uses radioisotopes.
In this policy statement, the NRC stated:
- 1. The NRC will continue to regulate the medical users of radioisotopes as necessary to provide for the radiation safety of workers and the general public.
- 2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
- 3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
NRC published final rule, " Misadministration Reporting Require-May 1980 -
ments" to require a quarterly report of all diagnostic misadministrations in addition to the prompt reporting of therapy misadministrations.
In the pre mble to this rule, NRC stated, "The Commissions's purpose in requiring misadministration reports to NRC is to identify their causes in order to correct them and prevent their recurrence. The Commission can do this by notifying other licensees if there is a possibility that they could make the The Commission can also change its regulations to prevent same errors.
specific errors."
December 1985 - NRC Office for Analysis and Evaluation o3,arational Data (AEOD) report on therapy misadministrations reported to the NRC from November 1980 through July 1984. NRC licensees reported 27 therapy misadministrations..
Sixteen of the therapy misadministrations involved teletherapy treatment, five involved brechytherapy treatment, and six involved radiophermaceutical therapy treatmeet.
For snitteen of the 27 misadministrations (48%), the patients were l
3 overtreated by 20-200% and, in one misadministration case, at least 53 patients were undertreated by 10-15%.
Three of the misadministration cases met the Commission's criteria for abnormal occurrences related to misadministrations-and thus were reported in the Quarterly Report to Congress on Abnormal Occurrences. The types of errors that led to most of the misadministrations are similar to one another, indicating that there may be a significant potential for these types of errors to occur and thus to continue to occur in the future. These errors primarily resulted from inadequate training, inattention to detail, and lack of redundancy.
January 1986 - Teletherapy misadministration reported by Washington Hospital Center in which a patient was administered 150 rads with no request or desire for such treatment from the referring physician.
April - December 1986 - Based on analysis of previous events, GA0 and AEOD reports and apparent lack of authority to cite medical licensees for negligence resulting in therapeutic misadministrations, the NRC Commission directed the staff to develop rulemaking to implement certair ~Jality assurance (QA) steps to reduce the chance for therapy misadministrations.
The Commission deemed this action necessary to provide for better patient safety and to provide a basis for enforcement action.
October 1987 - NRC published a proposed rule on " Basic Quality Assurance ir.
Radiation Therapy" and an advance notice of proposed rulemaking for a comprehensive QA program in the medical use.of byproduct material. The proposed rule was a prescriptive rule which would require licensees providing radiation therapy and certain iodine administrations to implement certain (QA) steps. These steps were intended to address inadequate training, inattention to detail, and lack of redundancy.
July 1988 - After analysis of public comments and briefings of the Commission by representatives of the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI) and professional associations, the Commission directed the staff to draft a performance-based rule and to conduct a pilot program to determine if compliance with the proposed rule would interfere with clinical practice.
November 1988 - March 1989 - Three public. meetings held to assist in the development of a proposed performance-based rule, regulatory guide, and pilot program.
January 1990 - NRC publishes proposed rule for a performance -based basic (QA) program, and modifications to the records and reports of misadministrations or events relating to the medical use of byproduct material. This proposed rule contained requirements to establish and implement a basic QA program for all diagnostic and therapy administrations.
It also contained proposed modifications to the definition of " misadministration" and the associated reporting and recordkeeping requirements.
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March 1990 - March 1991 - To collect additional inf6rmation about the proposed rule, NRC conducted a pilot program including 10 pilot program workshops, workshops with professional associations, the Joint Commission on Accreditation of Healthcare Organizations (JCAHD), the Agreement States, and met with the ACMUI.
All these workshops and meetings were open to the public, and prior notice was given through Federal Register announcements.
July 1991 - NRC published final rule, " Quality Management Program and Hisadministrations".Thefinalruledeleteddiagnosticcomgonents,except certain iodine procedures, and modified the definition of misadministration".
The modifitation of the threshold doses for identifying a diagnostic radiopharmaceutical misadministration is significant and will result in the elimination of 99% of previously required reports of diagnostic misadmin-istrations.
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ENCLOSLME 3 Revised Estimated Burden-l l
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s The increase in burden is due to an increase-in the estimated number of licensees affected by the QM Rule-from 3300 to 4620; an increese in the estimated time required for submittal of QM programs from I hour to 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />; and the addition of an estimate of the burden for submitting information to-the NRC when a licensee makes changes to a QM program. -The increase in the estimated number of licensees who may be affected by the rule is based cnta-reanalysis of the number of licensees in the applicable NRC program codes and the approximate 1400 licensee submittals already received by NRC.- In reexamining our estimates, staff has concluded that a more accurate, albeit more conservative, number would be reached by considering the number of NRC licenses authorizing-use of material which would require a QM program,:less an estimated percentage of licenses where this material is authorized but not used.
It should be noted, however, that the first year burden has already been expended by approximately-90 percent of the estimated number of NRC licensees affected by the QM Rule.
Although discuss #ons with OMB have been ongoing, the QM Rule became effective on January 27, 1992. Because the collection of information in the proposed rule was approved and is effective unless OMB disapproves of the collection requirements associated with the.. final rule, the staff,has been collecting.
information required by the QM Rule. Our Regional Offices have indicated that most licensees have already complied with the requirement to-submit to NRC a written certification that their QM program has been implemented along'with a copy of the program. The burden already expended by these licensees is approximately 65 percent of the increased total revised first year burden (attached Table).
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- Table 3 (Continued)
Burden associated with the Final Rule Final Rule Item Assumed Hours Total Section No. of Per Burden No.
Events /yr Event Hours /yr 35.32(a)
Develop a written QM 154 40 hr 6,160 hr/yr (RK) program (4,620x10%/3yr) 35.32(b)
Develop procedures for 154 4 hr 616 hr/yr (RK) review (4,620x10%/3yr)
Retain records of review 4,620 1/6 hr 770~hr/yr for 3 yrs (4,620).
35.32(c)
Retain records of recordable This burden is included in events.
Table'4 (See Burden Associated with the FinaT Rule).
35.32(d)
Retain records of written No cost - These records are directives and administered currently being kept by medical dose or dosage, use licensees as part of the patient's medical records.
35.32(e)
May make modifications to 2,310 2 hr 4,620 hr/yr (R) the QM program (4,620x50%)
35.32(f)(1)
Submit QM programs 1,540 5 hr
- 7,700 hr/yr (R)
(4,620/3yr) 35.32(f)(2)_
Submit written certifications No cost - This is part of (4,620/3yr) burden required for submitting the QM program Burden for QM Requirements
- Reporting 12,320 hr/yr.
- Recordkeeping 7,546 hr/yr-Total 19,866 hr/yr i
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- This is a revision of the Table found on page 16 of the September 9, 1991 l
supporting statement to OMB.
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ENCLOSURE 4 Discussion of OMB Concerns e
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4 DISCUSSION OF OMB CONCERNS 1.
GIVEN THE ALREADY LOW RATE OF MISADMINISTRATIONS AND ABNORMAL OCCURRENCES, THE NRC HAS FAILED TO DEMONSTRATE HOW THESE REPORTING REQUIREMENTS ARE LIKELY TO FURTHER DECREASE THESE RATES, AND THUS HAVE ANY PRACTICAL UTILITY.
NRC agrees that the current rate of misadministrations is_not high.
- However, the Commission has the expectation this rule will further reduce misadministrations through improved licensee performance. Hisadministration reports enable NRC to assess the appropriateness of regulations by gathering background on a particular subject to develop information with which to fine-tune those regulations, if necessary.
In addition, this information may provide the basis for information notices or bulletins to other licensees so that they can avoid the same errors.
The recordkeeping requirements associated with the QM Rule, which include the written directive and development of a written QM program were designed to enhance communications within the licensee's staff and also provide a basis for inspection.
2.
THERE IS SIGNIFICANT CONCERN WITHIN THE MEDICAL COMMUNITY THAT ANY STEPS WHICH MUST BE TAKEN WHICH ARE NOT DIRECTLY RELATED TO THE DELIVERY OF SAFE AND ACCURATELY ADMINISTERED PROCEDURES MIGHT BE DISTRACTING AND LEAD TO OTHER MISTAKES.
NRC shares the concern that superfluous procedures may contribute to other mistakes.
For this reason, the QM Rule focuses on the delivery of safe and accurately administered procedures. The objective of the QM program is to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.
3.
PHYSICIANS WILL NEED TO DESIGN AND IMPLEMENT A QUALITY ASSURANCE PROGRAM AND RECORDKEEPING SYSTEM TO SATISFY THE NRC'S REQUIREMENTS, EVEN THOUGH MOST PHYSICIANS ALREADY HAVE QM PROGRAMS DESIGNED AND MONITORED BY PROFESSIONAL ASSOCIATIONS.
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l As your correspondence indicates, most practitioners already implement quality management programs on a voluntary basis.
Although_those physicians who have not adopted these voluntary programs will need to design and implement a QM program, the majority of practitioners have existing initiatives to improve l
quality assurance which would, in most cases, require only minor modifications to satisfy NRC's requirements.
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..IT IS LIKELY THAT THE DEVELOPMENT OF A COMPLETE QUALITY MANAGEMENT PROGRAM WOULD TAKE LONGER THAN THE 40 HOURS INDICATED IN THE ICR'S SUPPORTING STATEMENT.
In the revision of the recordkeeping and reporting burden (Enclosure 6) HRC has not revised the 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> as indicated in the init'el ICR.
The 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> is an average figure for those licensees who do not have a program.
In addition, a majority of licensees who need to develop QM programs use byproduct material restricted to Nuclear Medicine procedures and will require less than 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />.
Also, the estimated burden does include the time necessary for those who already have QM programs to review their programs against NRC criteria.
This burden was revised from I hour to 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> to reflect recent comments from licensees and staff.
5.
THE NRC SUPPORTING STATEMENT DOES NOT INCLUDE THE BURDEN FOR THE DEVELOPMENT OF DIAGNOSTIC CLINICAL PROCEDURE MANUALS DESCRIBED IN 10 CFR 35.2.
The NRC supporting statement does not include the burden for the development-of a diagnostic clinical procedure manual because the final QM Rule does not require such a manual. As you have pointed out, the definition of " prescribed dosage means the quantity of radiopharmaceutical activity as documented:
(1) In a written directive; or (2) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures".
The definition was phrased in such a way that the physician coulo use whatever existing current system of directions has been established for the administration of doses for diagnostic procedures, including the diagnostic clinical procedures aanual.
Since such a manual is required by Joint Commission on Accreditation of Health Care Organizations (JCAHO) requirements and is one of the prirciples in the ACNP guidelines for quality assurance in nuclear medical practice, the majority of physicians have already established such manuals.
Recognizing this fact in the above definition allows physicians to use what they already have.
6.
TO MAINTAIN THESE RECORDS (prescription that led to the dose) IN A FASHION THAT WOULD BE EASILY AUDITABLE, PHYSICIANS WILL PROBABLY HAVE TO KEEP A DUPLICATE SET OF FILES.
As OMB has pointed out, this information is generally already kept in patient files. NRC intentionally did not specify where the written directive must be maintained so that physicians would not have to maintain duplicate files.
Data pertaining to compliance with NRC regulations in a patient's file are auditable records.
Hospitals allow NRC inspectors to review data in patient files pertaining to existing requirements in 10 CFR 35.315, 35.415, and in the investigation of misadministrations and other events.
In these cases, the intact patient file is given to the inspector who extracts the required information and then returns the file intact.
NRC has no requirement for a separate file above and beyond that already maintained.
7.
OMB STATES THAT ALTHOUGH CHANGES TO A QM PROGRAM ARE VOLUNTARY, THE IMPLEMENTING REGULATIONS FOR THE PRA CLEARLY STATE THAT VOLUNTARY REPORTING REQUIREMENTS ARE COVERED UNDER THE SCOPE OF THE PRA IN 5 CFR 1320.7(c), AND MUST BE INCLUDED IN THE BURDEN CALCULATIONS.
NRC has included an estimate of this burden in the revision of the total burden in Enclosure 6.
8.
OMB BELIEVES THAT MOST FACILITIES WILL IMPLEMENT OTHER RECORDKEEPING PROCEDURES AS PART OF THEIR PROGRAMS AND THE "THE NRC PROGRAM, AS OUTLINED IN THE RULE AND THE REGULATORY GUIDE, IS AMBIGUOUS IN SOME INSTANCES AND VERY SPECIFIC IN OTHERS".
OMB cites the ambiguity of whether or not clinical procedure manuals are required. There is no requirement for a clinical procedure manual in the final rule as discussed in item 5.
OMB cites the patient verification procedures described in Regulatory Guide 8.33, " Quality Management Program" as being very specific and "would better be left to the licensees's discretion".
The Regulatory Guide procedures are not.39itional requirements. The guide serves-as an example to licensees of procedures which would meet the objectives of the QH Rule. The adoption of these procedures, however, is left to the licensee's discretion. The Regulatory Guide serves its intended function as a specific example for meeting the requirements of a performance-based, not ambiguous, regulation. The information collection was tailored to meet the requirements of the final rule and those necessary for NRC to ensure compliance.
In response to comments from the medical community, NRC dropped an earlier prescriptive approach, and revised the rule to make it performance-based.
The Commission believes that the performance based rule will enhance patient safety while allowing the necessary flexibility required by this kind of regulation.
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....THE PERIODIC REVIEWS DESCRIBED IN SECTION 6 0F THE REGULATORY GUIDANCE DOCUMENTS ARE LIKELY TO IMPOSE A SIGNIFICANT BURDEN ON PRACTITIONERS WITHOUT HAVING ANY REAL PRACTICAL UTILITY........ ALTHOUGH IT MIGHT MAKE SENSE FOR THOSE FACILITIES THAT EXPERIENCED MISADMINISTRATIONS TO REVIEW THEIR PROCEDURES, THIS REQUIREMENT IS IMPOSED ON A SIGNIFICANTLY LARGER POPULATION WITH NO APPARENT BENEFIT.
With respect to OMB's comment regarding the burden of conducting annual reviews of QM programs, we note that an estimated 90 percent of licensees are currently performing such reviews in accordance with Quality Assurance programs required by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and similar organizations.
For these licensees, the annual reviews under NRC rules would not result in a significant incremental burden.
For the additional 10 percent of licensees who do not have such programs-in place, we-believe that the benefits of annual reviews in terms of providing continued high confidence that-byprodt.ct material will be administered as intended far outweigh the relatively limited costs. An estimate of the time for this requirement has been addressed-in the estimated burden. NRC licensees must meet the regulatory requirements, but not necessarily by.following the sample Regulatory Guide procedure.
The non-occurrence of a misadministration does not necessarily mean that a QM program is optimal, just as a misadministration does not necessarily imply the i
4 need for modification of the program. The purpose of the periodic review is to optimize the program before misadministrations occur, to be proactive rather ~
than reactive. Ixperience in inspecting medical licensees has shown that many facilities have program and/or personnel changes that may significantly affect performance.
From a regulrtory perspective, all facilities should review their procedures to ensure that individuals have been trained in the program procedures, that the program is in fact-implemented, and that any deficiencies are identified and corrected. The purpose of the QM Rule is not to rtduce misadministrations to zero but rather to provide high confidence that byproduct material or radiation from typroduct material *dll be administered as directed by the authorized user physician.
A review of the QM program procedures established to ensure that byproduct material is administered as directed by the physician is an integral part of the QM Rule.
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INCLOSURE 5 Comparison of Recordkeeping and Reporting Requirements for the Existing Part 35, the Proposed QM Rule And the Final QM Rule Se 4
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- 1. DUnt1TY KANaGEMENT PROGRM RECOPDKEEP1HG REQUIMMENTS EXISTING RULE PROPOSED RULE
- FlKAL RULE **
o No existing QM o 8aste QA program o QH program program o 1.nnus1 review of e Annuti audit (add QN oAnnualaudit(addQM radiation safety programreview) programreview) progrts o None o Prescriptions o Written directives o None o Diagnostic referrals o None o None o Diag. clinical proceduras o None o Radiopharzaceutical o Adstaistered dose o Administ'ered dose (add teletharap (add teletherapy and brachytherapy) y and dosages (35.53) brachytherapy) o None o Diagnostic events
' o None o None o Therapy events o Recordable events REPORTINGREQUIRIMENTS
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EllsTING RULE PROPOSED RULE
- F1KAL RULE **
o No existing QA
- o Basic QA program o QM program program o None o Written certification o Written certification o None o Modifications of QM o Modifications of QH progran program I
- The proposed rule would affect all diagnostic and therapeutic procedures (estimated at 7.2 million procedures per year).
- The final rule would affect all therapeutic procedures and sodium todido procedures >30microcurtes(estimatedat 200,000 procedures per year).
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- 2. M15 ADMINISTRATIONS PECORDKEEPINGREQUIREMENT$
I EXISTING RULE PROPOSED RULE FIML RULE
- o Diagnostic misadas.
o Diagnostic misadas, o Diagnostic misadminstrations only if > 5 ros EDE or > 50-res organ o Therapy aisadas.
o Therapy at:6das..
o Therapy misadministrations and sodium iodido > 30-sicrocurtos l
REPORTING SEQUIRIMENT1**
i EXISTING RULE PROPOSED RULE.
FIEL RULE
- o Diagnostic misadas.
o Diagnostic misadas. e'Olagnostic misadministrations
> 0.5 ron whole body same as existing only if > 5 ros EDE or > 50 or >2 ren organ ros organ.
o Therapy misadas, o 7herapy aisadas.
o Therapy misadministrations and sodium iodido > 30 microcurtos o
- Threshold eliminates about gM of existing recordkooping and reporting requirements for diagnostic misadministrations.
notify NRC by phone, (2) subett a written
- Involving essentia11ys.[1)hysician, (4) notify the patient (5) provide a report, (3) notify referra p
written report to the patient.
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ENCLOSURE 6 Public Meetings and Workshops S
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I The NRC staff has held public meetings and workshops concerning the QA program for the medical use of byproduct material with the regulated community professional associations, and the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI) As shwn below.
All of these transcribed meetings and workshops were open to the public with prior notice given through Federal Register announcements.
The transcripts are available in the NRC Public Document Room, 2120 L Street NW, Washington, DC. The comments, concerns, and suggested rule modifications expressed at these meetings were considered by the NRC Commission and staff in the decision to continue with rulemaking and in the extensive modifications made to the proposed rule. The high-cost minimum benefit diagnostic requirements were eliminated, and the final rule focused on the requirements necessary to assure accurate adreinistration of therapeutic doses, where the result of errors could be more significant.
Public Meetings and Workshops Held 01/26/88 Bethesda, MD
- Medical Associations 11/07/88 Bethesda, MD
- Medical Associations 01/30 & 31/89 Rockville, MD
- Medical Use Licensees 03/03/89 Philadelphia, PA
- American College of Radiology 03/14/90 Rockville, MD The following Agreement States 12/18-19/90 Irving. TX attended one or more workshop:
AL, 02/07-08/91 San Mateo, CA AR, CA, IL, LA, MD, NY, RI, TX, UT, TX, UT, WA, and City of New York.
07/23/90 Rockville, MD American College of Nuclear Physicians and Society of Nuclear Medicine, 11/19/90 Reston, VA American Association of Physicists in Medicine 12/15/90 Reston, VA American College of Medical Physics, American College of Radiology, American Endoeurietherapy Society, and American Society for Therapeutic Radiology and Oncology.
12/17/90 Chicago, IL Joint Commission on Accreditation of Healthcare Organizations.
01/14-15/91 Alexandria, VA Advisory Committee on the Medical Uses 03/26/91 St. Louis, MO of Isotopes.
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Pilot Program Workshops Held (Sixty-four NRC or Agreesent State licensees participated 5
in one each of the following two cateJories of workshops)
/ 'Elmhurst NY Pre-trail period:
03/29/90 04/04/90 Chicago,;L 04/06/90 Atlanta, GA 04/18/90 Irving, TX-San Francisco, CA 04/20/90 Philadelphia,PA Post-trial period:
08/16-17/90 08/23-24/90 Chicaca, IL 09/06-07/90 Atlanta, GA 09/13-14/90 Irving. TX 20/25-26/90 '
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