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Responds to to Chairman Selin Requesting Any & All Public Documents Related to Senior Mgt Review of NRC Medical Use Program & Proposed Contract W/Nas.Senior Mgt Review Completed in June 1993 by C Paperiello Encl
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Issue date:	12/13/1993
From:	Bernero R; NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Gillin M; AMERICAN COLLEGE OF NUCLEAR PHYSICIANS
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.,4 ?t UNITED STATES f ., > * ' NUCLEAR REGULATORY COMMISSION

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%,*'...* DEC 131993 Dr. Michael T. Gillin Chairman American College of Medical Physics

-1891 Preston White Drive Reston,.VA 22091

Dear Dr. Gillin:

I am writing in response to your letter of November 10, 1993, to Chairman Selin. In that letter you requested ar.y and all public documents related to the senior management review of the Nuclear Regulatory Commission medical use program and the proposed contract with the National Academy of Sciences (NAS),

The senior management review was completed in June 1993 by Dr. Carl Paperiello, and a copy of that report is contained in Enclosure 1. At the same time that Dr. Paperiello was conducting his review, the staff of the Division of Industrial and Medical Nuclear Safety was preparing a Medical Management Plan for submittal to the Commission. The purpose of that plan was to consider major program issues and develop a management plan for improvement of the program. The final plan, which incorporated Dr. Paperiello's recommendations as well as the proposal for the NAS study, was sent to the Commission on August 31, 1993, as SECY-93-244. A copy of that Commission paper is contained in Enclosure 2 for your information. ,

At this point in time, our efforts to address the recommendations in the Medical Management Plan are just beginning. As you will note from review of the plan, it will involve staff efforts over a five year period beginning in this fiscal year and extending through fiscal year 1998.

With respect to the proposed NAS review, we ate in contract negotiations with

.NAS at this time. Enclosure 3 is a copy of the Commission memorandum of December 21, 1992, which directed the staff to develop a proposal for an external review of the medical use program as well as a copy-of the Statement of Work sent to NAS to conduct such a review.

If you have further questions regarding the Medical Management Plan, please contact Janet Schlueter'at (301) 504-2633. Questions regarding the proposed 9708270434 931110 PDR MISC 9708270432 PDR I

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Dr. Michael T.Gillin review by NAS should be directed to Patricia Rathbun at (301) 504-1407. We trust that this reply is responsive to your request.

Sincerely, Original signed W gg., , -

3 Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Senior Management Review

2. SECY-93 244

3. Commission memorandum DISTRIBUTION: ED09549 IM08 r/f NMSS r/f CPoland CEstep IMNS r/f-JTaylor E00 r/f OMorris HLTMmpson JBlaha EBeckjord RMurley JLieberman 0GC RVollmer JSniezek NMSS Dir. Off. r/f f

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IM0B* IMAB* IMNS* IMSS j) NMSS NMSS4k NAME GPangburn FCombs JGlenn EWBrach CPhi$110 GArlotto RBehrY DATE 12/03/93 12/03/93 12/03/93 11/03/93 IS #G/93 / /93 t VIJ/93 0FFICIAL RECORD COPY: a: & g:\93-597.gcp j

Dr. Michael T. Gillin review by NAS should be directed to Patricia Rathbun at (301) 504-1407. We trust that,,this reply is responsive to your request.

Sincerely,

/ <!/ W Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Senior Management Review

2. SECY-93-244

3. Commission memorandum

Dr.-Michael T.Gillin -review by NAS should be directed to Patricia Rathbun at (301) 504-1407, We trust that this reply is responsive to your request.

Sincerely, Originalegned by Boboa 11 F#"^ m Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards ,

Enclosures:

). Senior Management Review 2.. SECY-93-244 .

3. Connission memorandum DISTRIBUTION: E009549 IMOS r/f NMSS r/f CPoland CEstep IMNS r/f JTaylor ED0 r/f DMorris HLThompson JBlaha EBeckjord RMurley JLieberman 0GC RVollmer JSniezek. NHSS-Dir. Off. r/f 9

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-OSee previous concurrence OFC IM0B* IM0B* IMAB* IMNS* IMSS j) NMSS NMSS4k NAME. GPangburn FCombs JGlenn EWBrach CPhkIllo GArlotto RBehrY DATE -12/03/93 12/03/93 12/03/93 l}/03/93 ]> $&/93 / /93 f/IJ/93 t

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l Dr. Michael T. Gillin review by N4s shoul'd be directed to Patricia Rathbun at (301) 504-1407. We trust that this reply is responsive to your request.

Sincerely, Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Senior Management Review

2. SECY-93-244 3.- Commission memorandum DISTRIBUTION: ED09549 ,

IMDB r/f NMSS r/f CPoland CEstep IMNS r/f JTaylor EDO r/f DMorr'is HLThompson JBlaha EBeckjord RMurley JLieberman OGC RVollmer JSniezek NMSS Dir. Off, r/f 4 JSchlueter PRathbun N

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i Dr. Michael T. Gillin review by NAS should be directed to Patricia Rathbun at (301) 504-1407. We trust that this reply is responsive to your request.

i Sincerely, .

Robert ~M.

/ /Bernero, Director Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Senior Management Review

2. SECY-93-244

3. Commission memorandum 01STRIBUT10N: ED09549 IM0B r/f NMSS r/f' CPoland CEstep IMNS r/f JTaylor E00 r/f DMorris HLThompson JBlaha EBeckjord RMurley JLieberman 0GC RVollmer JSniezek NMSS Dir. Off. r/f JSchlueter PRathbun 4

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ACTION: CIRCULATED: FOR YOUR INF0:

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AS REQUESTED:

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NOTE AND RETURN:

PER CONVERSATION:

PREPARE REPLY: 0;N8[ #(@9 TICKET NUMBER: ED09549 REMARKS DUE TO DIVISION: 12/06 DUE TO NMSS: 12/06 DUE TO E00: 12/09

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MEMORANDUM / LETTER FOR: Dr. Michael T. Gillin, ACMP FROM:

R. Bernero, NMSS

SUBJECT:

Responding a ltr. of Nov. 10, 1993 to Dr. Selin ORIGINATOR / SECRETARY: GPANGBURN/ Phone: 504-2624 ROOM NO./ BLDG.:

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Internal Management Review of the U.S. Nuclear Regulatory Commission's Program for the Medical Use of Byproduct Material Findings and Recommendations Cari J. Paperiello June 1993

. Enclosure i

' 9YDN'l' '/dff).

h, TABLE OF CONTENTS

. INTRODUCTION

.-.................................., 1 1.0 CURRENT STATUS OF RADIATION MEDICINE . . . . . . . . . , . . . . . . . 2 3

2.0 REGULATORY ENVIRONMENT AND ROLE OF THE NRC . . . . . . . . . . . . . .

4 3.0 MI$3.1" ADMINISTRATIONS . . . . .-. . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..

Frequency of Misadministrations 5 3.2 Underreporting of Misadministrations .............. 6 3.3 Relative Patient Risk of Therapeutic Misadministrations . . . . . 7 3.4 Misadministrations Involving Radiciodine ............ 7 8

3.5 Causes of Misadministrations ...............

10 3.6 Prevention of Misadministrations .............. .

10 4.0 MISADMINISTRATION FOLLOWUP ... . . . . . . . . . . . . . . . . . . . .

4.1 Potenti al Followup Probl ems . . . . . . . . . . . . . . . . . . . 10 4.2 Proposed Followup Actions . . . . . . . . . . . . . . . . . . . . 12 4.2.1 Medical Misadministrations and Therapeutic Events (12);

4.2.2 Allegation Investigation Procedure and Training (13); 4.2.3 Formal Event Followup Procedure (13) 4,3 Misadministration Tracking and a National Database ..... , 13

.............. 14 5.0 MEDICAL LICENSING AND INSPECTION PROGRAMS 5.1 Size and Scope of Licensing and Inspection Program ....... 14 5.2 Licensing Guidance ....................... 15 5.2.1 License Reviewer Training and Qualification (16); 5.2.2 Medical Licensing Actions Reserved for NMSS Headquarters (17) 5.3 Inspection Program ...................,,.. 17 6.0 LICENSEE MANAGEMENT ACCOUNTABILITY AND RADIATION SAFETY OFFICER RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . .... 19

. . . . . . . 22 7.0 MEDICAL ACTION PLAN / MEDICAL ACTION ITEMS . . . . . . .

7.1 Specific Comnission Issues . . . . . . . . . . . . . . . . . . . . 22 7.2 Agenda for Medical Pecgram Improvements . . . . . . . . . . . . . 24 8.0 AGREEMENT STATE ISSUES . . . . . . . . . . . . . . . . . . . . . . . . 24 24 8.1 Status .............................

8.2 Observations and Suggestions .................. 25 9.0 INFORMATION MANAGEMENT SYSTEMS ................. 26 27 10.0

SUMMARY

0F REC 0lWENDED ACTIONS . . . . . . . . . . . . . . . . . . .

10.1 Ensure the Quality Management Program is Implemented by Licer. sees 27 10.2 Misadministration Followup . . . . . . . . . . . . . . . . . . 27 10.3 Revise Inspection Manual Chapter 2800 ............. 27 10.3.1 Reexamine Inspection Program Priorities in Manual Chapter 2800.(27); 10.3.2 Add Reactive Lnspection Procedures (28); 10.3.3 Revise Routine Medical Inspection Procedures (28) 10.4 Revise Licensing Practices and Guidance ............ 28 10.5 Licensee Management Accountability . . . . . . . . . . . . . . . 29 10.6 Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 10.7 Agreement State Issues . . . . . . . . . . . . . . . . . . . . 29 29 11.0 OPEN ISSUES ............................. 30 11.1 Enforcement Costs . . . . . . . . . . . . . . . . . . . . . . . .

11.2 National Program Review / Agreement State Radiation Control Program 30 11.3 Third Party Car cation . . . . . . . . . . . . . . . . . . . . 30 11.4 Length of License . . . . . . . . . . . . . . . . . . . . . . . 31

-c.

INTRODUCTION This report responds to the Connission's request to perform a management review of the existing medical use regulatory program (COMIS-92-026),

Enclosure 1. 'The review was conducted from March through June 1993. During this period, there were several events which influenced this report and the subsequent direction of the medical use regulatory program. These included preparation for the Glenn and Synar Hearings, and the agreement by Chairman Ivan Selin to provide options for the regulation of medical radiation to Senator Glenn by August 1993. In addition, NMSS continued to assemble various issues and requests into an ' Agenda for Improvements in the Medical Use 19, 1993.

Program" (Enclosure 8) which was sent to the Commission on May .

The current status of radiation medicine is another factor considered in this report. As will be discussed below, the science of radiation medicine has undergone major technological change and development since the 1950's when the Atomic Energy Act was written. The use of radiation and radioactive material in medicine and medical research is expected to continue to evolve and change rapidly. It is unlikely that these innovations will cease. This review was conducted with these developments in mind. Two other principles underlie this review:

1. The responsibility for radiation safety lies primarily with the possessor and user of byproduct material, and

2. The NRC should minimize its impact on licensees who are operating safely and who maintain compliance.

The review was carried out using a combination of interviews with NRC staff and management, contractor analyses, staff analyses, and review of relevant documents. Some issues were discussed with the Advisory Committee on Medical Uses of Isotopes (ACMUI) during its May 1993 meeting. Discussions were also held with Agreement State representatives during the week of May 16, 1993, at the annual meeting of the Conferent.e of Radiation Control Program Directors.

Cue to time constraints, neither of these groups has had an opportunity to review this report. The author also had the benefit of information from the HMSS Regulatory Impact Survey that he conducted.

The issues covered in this report were subject to time and resource constraints. Furthermore, some problems in the inspection and licensing area go beyond the medical use portion of the materials program. As the review progressed, it became apparent that the best course of action was to begin to implement some of the more pressing of the identified tasks, rather Furthermore, as thetoreview attempt

~ an exhaustive analysis of all possible issues.

progressed, the staff continued to modify its regulatory program.

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, 1.0 CURRENT STATUS OF RADIATION MEDICINE 1 Radiation medicine is a mature science comprised oft a large number of physicians and other allied health persor.ael who are highly educated and trained in various sub-specialties; numerous a substantial literature and a variety "credentitling organizations;ine use by techno Wgists. Research i of radiation sources in rout !

laboratory instruments of the 1950s and the 1960s, when the byproduct material medical use regulations and programs were being developed, l i

are now routinely used in community hosp <tals and clinics. The :

3 physical, chemical and biological properties of radioactive material and tonizing radiation are relatively well-known, and probably known f i

better than most other toxic substances. With tens of~ thousands of users, in principle there is a large body of experience from which we can draw statistically valid conclusions concerning events that impact ;

public health and safety.

The first isotopes used in research and medicine were accelerator produced and very scarce. After the nuclear reactor was created, isotopes from fission and neutron activation became available in large quantities. These radioisotopes quickly dominated the fields of research and medicine. Cobalt-60 (Co-60) provided a convenient source of photons with higher energies than the orthovoltage x-ray machines (up to 500 kev) that were in use for radiation therapy.

Reactor-produced isotopes displaced radium-226 for brachytherapy.

Although charged particle reactions, using a variety of particles and ;

targets, can produce a greater variety of isotopes than designed fission orfor j

neutron activation, research accelerators at that time, limited by i purposes other than #ats radioisotope production, were '

their beam currentt ..) the quantities of radioisotopes they could j produce. 4 i

Since that titee, there has been substantial technological growth on several fronts. Sophisticated radiation detection and measurement i systems have dropped in cost due to advances in electronics presenceandof computers. Advances in accelerator design and the l commercial vendors in the marketplace have led to tie connercial ,

availability of production cyclotrons with very high beam currents. l i

Similarly, compact linear electron accelerators with energies and .

outputs higher than Co-60 devices and comparable in cost are J dominating the fleid of radiation therapy. Equally important is the growth in the number of medical and allied health personnel in the field. These individuals with professional and advanced degrees have the required skills to operate and maintain this sophisticated equipment. This is an important point. Without these highly educated and skilled people, this new equipment would be useless. In fact.

much of the used Co-60 equipment is being sold to third-world l countries because it does not require the technical infrastructure required by this newer equipment.

Paralleling these developments, has been the growth of two complex systems. The me:!ical services del;very system has grown large and 2 i

e complex due to the increased specialization of ohysicians and the incorporation of a large number of allied health and clerical personnel into the system, in some cases, command, control and communications do not appear to have kept pace with this growth.

Secondly, medical diagnosis and treatment systems involving computer

" driven electro mechanscal systems are susceptible to failures that are not imediately apparent to the user and whici, frequently require complex analytical procedures beyond the capabilities of the user to detect.

I 2.0 REGULATORY DN!ROMENT A2 R0Lt 0F THE NRC The Atomic Energy Act (AEA) of 1954, as amended, authorizes the Commission to issue general or specific licenses to applicants seeking to use byproduct material ... for medical diagnosis and therapy ... or such other useful applications as may be deve oped. All other medical uses and sources of ionizing radiation, except for the direct use of radiation from a nuclear reactor, are regulated by other entities, generally the States. For the most part, these uses and sources of ionizing radiation differ little in risk and characteristics from byproduct material regulated under the AEA. The one major exception to this generality is that intense, relatively long-lived radioactive sources are almost always reactor-produced.

As authorized by Section 274 of the Atomic Energy Act, the Comission has entered into agreements with Zg States to relinquish its regulatory authority over byproduct and other material. Therefore, in these States the State theoretically has authority over all medical uses and sources of ionizing radiation. In the remaining 21 States, the NRC regulates the medical use of byproduct material, while the State either licenses or registers other sources of ionizing radiation. A few States do very little at all.

Section 274 of the Act is intended to create an environment of which the States improve their cooperation capabilities to regulate materia under this Section. The Commission with the States and,l is also authorized and directed to cooperate with the States in the

formulation of standards for protection against hazards of radiation and to ensure that State and Commission programs for protection against the hazards of radiation are coordinated and compatible. This Section also provides the Commission with the ability, upon its own initiative after reasonable notice and opportunity for hearing to the State with which e9 agreement has been entered, or upon the requast of the Governor of such $ tate, to terminate or suspend all or part of its agreement with the State and reassert the Itcensing and regulatory authority vested in it under the Act, if the Commission finds that (1) such termination is required to protect the public health and safety, or (2) the State has not complied with one or more of the requirements of this Section.

3 y

The NRC theoreti olly has very broad authority undir the Act to regulate medical uses of byproduct material (use of sourcu and $NH in the medical area is limited to shielding and cardiac pacemakers).

However, there are practical limits on NRC authority associated with

,, staff expertise and variations among licensees. The NRC staff exprtise in the medical area is limited. Although radiation medical professionals include medical physicists, physicians certified in nuclear medicine, radiology, and radiopharmacists, with the exception of consultants and visiting medical fellows, the NRC employs approximately eight medica physicists, but no physicians or licensed nuclear pharmacists. Furthermore, it makes little sense to have a regulatory posture so draconian that the medical community is driven to choose radiation modalities primarily to avoid NRC jurisdiction.

This is particularly true since some of these modalities require greater user sophistication than modalities using NRC regulated material. Thus, imprudent regulation could have an adverse impact on public health and safety.

What should the role of the NRC be? The NRC has, and should improve, its leadership role in the regulation of radiation safety in'the planned use of radioactive material. In addition to those activities which the NRC directiv regulates, the NRC provides significant resourcesbothdirectlyandindirectlytotheStates. The HRC's primary radiation protection standards and basic licensing regulations serve as a focus for numerous consensus standards and secondary radiation safety supporting criteria. For those licensees directly regulated by the NRC, regulations and requirements should be reasonable, succinct, and understandable; the licensing process should be efficient and timely; inspections not'.d enhance safety and promote performance; and enforcement shoul6 encouSage licensee responsibility.

Finally, the NRC regulates a broad spectrum of medical licenseec.

There is a wide vartation in size from large teaching hospitals and medical centers to stand-alone diagnostic and therapy clinics with single physicians or partnerships. As in all fields of endeavor, there is a variation in talent among the practitioners. In spite of a tough credentialling process in the medical area, it appears possible that a physician may perform a procedure for which the individual is not fully qualified. I.astly, advanced education does not make an individual issuune to ethical failures and NRC needs to be alert to potential wrongdoing.

3.0 MISADRINISTRATIONS Recent events have brought NRC regulations concerning radiation therapy misadministrations and the reporting and followup of these misadministrations to %blic, Commission, and Congressional attention.

In several memoranda dated early February, 1993, the Office of the General Counsel questioned the NRC's implementation of current 4

o misadministration requirements. Individual Commissioners have questioned the lack of accurate statistical infomation and the desirability of a national database for therapeutic misadministrations.

" Sections 3 and 4 of this report examine a number of issues surrounding misadministrations and their review by the NRC, and proposes a number of practices and procedures which should improve the overall handling of misadministrations and other similar events.

3.1 Rate of Misadministrations Although accurate statistical data are not available, there are several sources that permit order of magnitude estimates of therapeutic misadministration rate, assuming reasonable detection and reporting probability. Dr. Myron Pollycove, Visiting Medical Fellow, in a memorandum (Enclosure 2) dated March 8, 1993, to John Glenn, provided an estimate of the radiopharmaceutical therapy the total administrations received misadministrations based on from the American College (1)diolo y and Radiopharmaceutical of Ra Manufacturers and Distributors, and 2) misadministratio's n obtained by scaling the number of misadministrat ons reported in the 21 NRC States to the entire United States, based on population ratio. There is no a priori basis to assume a difference between Agreement States and NRC States. Dr. Pollycove estimates the annual radiation misadministration rate from sealed and unsealed radicactive sources to be 2.6E-04.

NCRP.Cunentary No. 7, Misadministration of Radioactive Material in b dicine - scientific Rackaround, dated October 1, 1991, provides information that permits an estimate of diagnostic misadministrations.

There are an estimated 1300 misadministrations per 7 saillion diagnostic examinations each year. IfThis results inthat we assume a the therapeutic misadministration rate of 1.gE-04.

misadministration rate is comparable to the dingtostic misadministration rate, this result is consistent with Dr. Pollycove's estimates.

Human factors studies provide insights into human error rates for relatively simple processes (i.e., misreading labels, switch selection,etc). As shown in Enclosure 3, typical error rates for activities controlled by procedures range from IE-3 to IE-4 depending on the degree of control over the process. Although not all misadministrations are caused by human errors, errors of commission or omission contribute to most. Furthemore, some human errors as well as mechanical failures are caught by redundancy in the therapy delivery system. Therefore, an order of magnitude estimate of 2E-4 rate for misadministrations is consistent with our knowledge of the error rates which contribute to the events.

Furthermore, there are uncertainties in both the numerator and the denominator. As discussed below, there is reason to believe that some 5

g is

l The misadministrations are not recognized and reported.

Cossaissioners' testimony at Senator Glenn's hearing illustrated the difficulty in defining tue denominator because we do not know for sure how many procedures are performed. Actually, the problem For example, is made more difficult due to differences in treatment modalities.

,. consider a condition for which a patient may receive high dose rate or low dose rate brachytherapy. The low dose rate treatment will dose The high generally be given in one treatment of several days. ra period of several days or weeks. Should we count the in the other case we have several treatments.

number of misadministrations per patient, per treatment, or per billable procedure?

Many are Not all misadministrations have severe or fatal outcomes.

underdoses; some are errors in the treatment fraction that are correctable by adjustments in future fractions, and some involve one or two fractions delivered to an unintended portion of the body.

Dr. Pollycove estimates that serious misadministrations are aboutMy rev 10 percent of all misadministrations.

Analysis and Evaluation of Operational Data (AE00) file of 35 misadministration reports for 1992 involving 51 patients shows 31 to be underdoses.

part, ono resulted in a fatality, the Oncology Services HOR event, and one resulted in the loss of a normal thyroid.

3.2 Underreporting of M)sadministrations The It is likely that misadministrations have been underreported.

misadministration discussed above that resulted in the loss of a normal thyroid was not reported until the licensee read of a similar On o:casion, an inspector misadministration in the HMSS Newsletter.it is also likely that the has identified a misadministration, increase in therapeutic misadministration reports in the past In addition, ' bugs" few in years is due to greater licensee awareness.

computer software could cause multiple misadministrations that would go undetected and unrecognized, particularly if significant clinical manifestations were absent. Quantifying this problem is difficult.

One way to determine quantitatively the degree of underreporting as well as determining a "true' misadministration rate might be to sample a sufficiently large number of patient records. This would probably require the examination of thousands of patient flies. The number reviewed would depend on the accuracy desired. Since this examination would require skills and faul11arity with medical records that most inspectors do not have,A survey this review of would have to be perfonned by contractors.

5,000 patient flies is estimated to cost about $300,000 and have a significant impact on several dozen licensees chosen for the review. Depending on the results, this sample may still be too small. A sample large enough to give a 6

statistically better estimate than now available may require approximately 50,000 patient files. Even this crocess would not identify the software induced misadministrations that have not been identified.

" ThW report does' n'ot recoassem+ expending significant resources trying to identify a.'true' misadministration rate. It is likely that there are sufficiently different failure trees for each treatment modality such that each has its own 'true' misadministration rate.

Furthermore, nach modality has a different probability of causing serious harn given the fact that a misadministration has occurred.

3.3 Relative Patient Risk of Therapeutic Misadministrations Evaluation of the patient risk from therapeutic misadministrations must take into account the underlying reason for performing the procedures. Today, except for hyperthyroidism and arteriovenous malformations, radiation therapy is used for treatment of cancer a Furthermore, generally f atal category of diseases if left untreated.

alternative cancer treatments involve significant patient risk even if the treatment is delivered as planned, in a memorandum to John Glenn dated February 1, 1993 (Enclosure 4),

Dr. Myron Pollycove presented the relative risks of radiation therapy, general anesthesia, surgery, and chemotherapy in the treatment of five common aalignancies that respond relatively well to treatment.

Dr. Pollycove's data show that mortality risks are in the order of IE-2 or greater for surgery, (IE-3 for general anesthesia, 2E-3 for if delivered as crescribed.

chemotherapy, IE-2 for radiation therapy,l in the case of cervical cancer, colorecta cancer and Hodgkin's disease, 7E-4 for radiation therapy in the case of prostatic cancer.

and 6E-6 for radiattoa therapy misadministration. The morbidity risk is ont to two orders of magnitude greater.

Untreated cancer is almost always fatal and treated cancer is fatal in about 50 percent of the cases. The accepted radiation treatment grotocols involve a patient fatality risk of several percent and much iigher morbidity risks. Therefore, the overall contribution of misadministration risk to total risk for cancer patients undergoing radiation therapy is very small. If the "true' misadministration rate is two or three times higher than current e:timates, this conclusions is unchanged.

3.4 Misadministrations Involving Radiciodine usually iodine-131, is a special case for several Radioactive reasons. It is use therapeutically to treat hyperthyroidism, a non-iodine,d malignant condition but a disease with potentially fatal consequences if left untreated. Misadministrations during diagnostic studies can result in a loss of thyroid function in a previously normal thyroid, lodine-131 is the most likely radiopharmaceutical currently used that.

7

if given unknowingly to a pregnant or nursing female, will affect the fetus or infant. <

For the long-term control of hyperthyroidism, radiciodine therapy is the treatment of choice. Although misadministrations have occurred,

,,the currently accepted treatment protocol is to render the thyroid hypothyroid and place the patient on long tern synthetic thyroid replacement therapy. Therefore, the ult' mate outcome of an overdose ,

misadministration in this case is rarely different from the long-term i desired outcome.

Other misadministrations of radiciodine are, in a relative sense, much more serious. A diagnostic procedure may be ordered to rule out a problem. In this case a misadministration which retults in a normal >

thyroid becoming hypothyroid is a relatively severe outcome. This can also be the likely outcome to an infant if a pregnant or nursing female inadvertently receives a high dose. Untreated hypothyroidism in an infant will result in mental retardation and other developmental handicaps and impose serious burdens, both financial and otherwise, on the family and society.

3.5 Causes of Misadministrations This section summarizes the findings of three separate reviews of misadalaistrations: the draft NUREG/CR, S - rv of 1991 and 1992 Misadministration Event Investinations. presenting the results of contract work by the Idaho National Engineering Laboratory (INEL) to investigate seven misadministrations in depth; a special review of NRC I

data on other misadministrations by the same INEL group in support of this report; and a somewhat subjective review by this author of cases examined by the Quality Management (QM) Panel for enforcement action, in this latter review, all of the cases involved potential violations of the QM rule (10 CFR 35.32), but not all were misadministrations.

Enclosure 5 presents the Executive Sumary from the INEL draf t HUREG/CR. That report concludes:

Many misadministrations occur primarily due to a lack of rigorous procedures intended to ensure patient and staff safety;

While the QM rule has the potential to prevent many misadministrations, a number of licensees have not effectively implemented their QM program;

A lack of substantive, direct involvement on the part of Radiation Safety Officers and Authorized Users is often a factor in misadministrations;

Hardware failures occur very infrequently but can lead to severe consequences, particularly when operating rocedures, staff training, or other factors are not well imp emented 8

Changes in routine and unique conditions are factors which often predispose misadministrations.

1NEL also conducted a special review of events using the existing NRC database of Abnormal Occurrence events reported in NUREG-0900 for the

" years 1987 through 1991 and misadministration events contained in the INEL was requested to identify comon causes AE00 database for 1992.

of misadministrations, identify correlations between direct causes and severity of misadministrations, determine if proper implementation of the QM rule could have prevented these events, and analyze the causes of multiple misadministrations and adequacy of licensu corrective actions to prevent ruittple events. INEL's report is contained in Enclosure 6. The report finds:

1) Proper implementation of a QM plan conid have prevented as many as 94 percent of the patient misadministrations-included in the database.

2)

A relatively small number of licensus (11) have experienced multiple misadministrations due to comon cause failures. These multiple misadministrations, however, involved 60 percent of the patients in the database.

3)

Errors in entering data into computer programs or computer programming errors are tne dominant area in which direct causes result in multiple misadministrations.

In descending order, inadequate procedures or failure to 4)llow fo procedures, professional errors (what INEL calls random errors made by an individual), and communication problems are the most significant direct causes of single misadministration events.

5) Inadequate procedures or failure to follow procedures and communication problems are most correlated with misadministration severity. ,

A review, by this author, of the misadministrations that occurred since the Qtrule becaer effective shows that most would not have occurred if an adequate Qlt program had been effectively implemented.

Mestr fafTures were syst'emic; procedures were lacking; procedures te address. en the requirements of the QM rv .e and some ETTilgte notrtreined in the precedures. In some cases, the f

training was se poor that licensee personnel were unaware of the QM implementing procedures. In addition, during rcutine regional inspections, inspectors identified licensees that were required to Frequently, have QM programs but were unaware of the requirements.

RS0s and authorized users named on the license exercised very little oversight over licensed activities.

9

3.4 Prevention of Misadministrations Vigorous implementation of the existing NRC requirements, especially should significantly reduce the number theQMProgram(10CFR35.32)Iybeingidentified, of misadministrations current Most misadministrations are preventable.

In 10 CFR Part 35.32 f(2), each licensee who was required to have a QM Program, was required to submit a copy of the program to the appropriate region by January 27, 1992. NM55 planned to hire a contractor to review these plans because it was believed that the Regions lacked the resources to properly review them. However, for a The variety of reasons, a contractor has only recently been selected.

contractor will review approximately 1600 plans. Review of these plans is important.

Although inspectors are finding problems with implementation of the QM rule, most of these problems are obvious, as noted in Section 3.5.

After a contractor reviews approximately 100 of the plans, NMSS will evaluate the findings and determine whether additional actions by Headquarters or the Regions are needed. Findings may show that the problems are so obvious they can easily be identified by an inspector while preparing for an inspection. On the other hand, generic problems may be identified that warrant a generic solutton.

4.0 MISADRINISTRATION FOLLOWUP 4.1 Petential Followup Problems Fundamentally, NRC inspectors are technical individuals who are well qualified to identify and resolve technical issues. Most of the training provided by the NRC to new inspectors is technical (i.e..

Manual Chapter 1245). Generally, inspectors are poorly equipped by training and temperament to deal with problems involving deliberate deception, or to identify ineffective licensee management without readily identifiable viciations.

The NRC has detailed inspection procedures for technical inspections and provides comparable training. There are no equivalent procedures for misadministration followup, allegation followup, or similar

in these l

(

reactive areas. Some inspections; nor is there substantial relevant training reactive inspections, such as Incident Investigation Teams !!Ts) and is provided by AE00 for trainin l

Augmented Inspection Teams CAITs). Furthermore, these types of inspections have substantial management involvement by Headquarters and Regional managers and redundancy in reviewing the findings. In the case of nuclear reactcrs, the level of management review by NRF and Regional managers per site is also substantial.

According to the Office of Enforcement (CE), in FY 90 through FY 92 10 W1. >>=e.'w'uHr.r+-*-we -e m--em+- a*-=-me- re-+= = >ee---++a- ne +-w--*--'w..r--+r- *.vmW s-w m emwa - - h4- er+- - - - - - * -a'. r m ehme- ' * - + - 'm- m --eee++==-ee-*-a-e-e4ee==>

there have been 184 power reactor civil penaltive and 17g material civil penalties, in the same period there have been 21 completed Office of Investigations investigations at power reactors and 52 completed investigations at materials facilities. During the same period about 30 percent of all allegations involved materials. These

" data reflect the reactive work load in these areas. However on a

. national and regional basis, there is substantially less mana,gerial and supervisory oversight per materials licensee, event or case, than for power reactors. G'vonthehumanerrorratesshownInEnclosure3 and the number of opportunities for error, additional procedures, guidance, and oversight is needed to ensure appropriate agency followup of materials events, including misadministrations.

Furthermore, most materials licensees are far less knowledgeable than reactor licensees. Frequently, materials events are reported to the wrong place in the NRC, the last inspector to visit the licensee, or a license reviewer. Licensees do not always provide the needed information about an event and frequently do not know, with certainty, if an event is reportable. Consequently, garbled information gets to an individual who may not have the experience and knowledge to ensure an appropriate agency response.

Followup to determine if deleterious effects result from misadministrations is not simple. Some serious deterministic effects may not manifest themselves for months. Furthemore, a cancer patient's reaction to a given radiation dose may be affected by the disease itself or additional treatment by chemotherapy. The NRC lacks in-house medical expertise and must rely on consultants to evaluate this information. When a patient dies, the NRC lacks the legal-authority to make a final detemination of the cause of death, which might require an autopsy. This authority and responsibility usually resides with the attending physician, a coroner, or medical examiner.

This process is prescribed by State law.

However,-determination of the possible consequences of a misadministration should be within the skills of the medical consultant. Textbooks provide tables of thresholds for organ doses in which radiation lesions are fatal or result in severe morbsdity. The NRC has previously used this type of data in development of NUREG/CR-4214. Health Efdacts Mamla for Mue' aar Power P' ant Accident Canneauonce Ana' vain. Ne problem 's more diff cu't than a mere inspect'on of reference tables. Adjustments have to be made for fraction effects and d6se rate. There are models and generally accepted textbook techniques for doing most of these calculations.

With the proper knowledge and experience, an expert can determine the nrobable consequences of a given dose (dose distribution) to a patient.

11

i 4.2 Proposed Fe11owup Actions 4.2.1 Medical Misadministrations and Therapeutic Events Medical misadministrations and events involving high doses require prompt followup. Appendix A provides an outline of a procedure for misadministration followup that permits the determination of the extent and depth of followup needed for each situation. This procedure will ensure the inspector assigned is properly qualified and trained, will ensure consistent inspection extent and depth, and ensure the involvement of a medical consultant, the Office of the Geseral Counsel (0GC), the Offica of Nuclear Material Safety and Safeguards (NM55), and of the ensure patient notification Office of Enforcement (DE). It wil since the patient will be sent a copy of all information available to the NRC unless the referring physician provides the NRC with a valid reason why it should not be sent to the patient.

It provides for an NMSS misadministration coordinator to ensure that retrievable records are maintained and information is disseminated.

The procedure provides that the NRC will make reasonable attempts to identify all patients who have received therapeutic misadministrations and ensure that notifications required by the regulations are made. It provides for long-term followup of patients through the voluntary participation of the patient in the Department of Energy's (00E'sh office of Epidemiology Thisand Health Surveillance 1.ong-Ters Med1 cal Study Program. Inclusion program currently has about 2700 individuals enrolled.

in DOE's program appears to be the best way to cbtain any information of scientific value that might be derived from such an event.

Normally, enforcement actions are not completed for several While enforcement actions are pending, months after an event.

NRC is nomally kept informed of any significant patient complications known to the licensee. As a practical matter, the NRC usually obtains a level of knowledge of the consequences of the event proportio%i b its likely severity. Most of the therapeutic misadsinistiat has reviewed for 1992 had minor or no observable deterministic effects, or were underdoses. In serious cases the NRC was deeply involved. Practically, the NRC cannot compel patient cooperation in long-term followup.

With the proposed procrdures in bpendix A, NRC management 'ill have sufficient inforsation to mate a stronger response, including a decision for longer tem involvement in those cases where severe morbidity or mortality is a likely outcome. The procedure proposes to accomplish this to the extent practicable through issuance of an Order to the licensee.

12

In cases in which the NRC believes that death has occurred or is a likely outcome of a misadministration, the procedure provides for the NRC to give this inforsation to the appropriate local legal authorities.

- 4.2.2 Allegation Investigation Procedure and Training Inspectors' ari not trained in what constitutes legal evidence. what There are no procedures to assist them in determinin idity or constitutes adequate information to establish the va falsity of an allegation when there is the potential fer tampering with data. With time, most inspectors gradually However, this cannot develop a sense of when something is wrong.The NRC needs an allegation be left to chance.

procedure; allegation followup should be restricted to senior inspectors; and these inspectors need additional training in investigative techniques.

This training could be provided by the Fedtral 1.aw Enforcement Training Canter in Glynco, Georgia. This Center offers a two week course, ' Introduction to Criminal Investigations Training Program," to acquaint non-investigator personnel with the procedures, techniques, concerns, and probisms associated with criminal investigation. The target group includes regulatory inspectors, paralegals, auditors, technical personnel, and others who might assist in~a~ criminal investigation, or be required to ;

testify in a criminal matter l, 4.2.3 Formal Event Fellowup Procedure A prescriptive event-followup procedure is needed for those events wnich do not warrant an !!T or AIT. During the Regulatory Impact Survey, some licensees complained that, when inspectors respond to a reported event, they concentrate solely on violation 6. Many of the recent inspection reports reviewed by the QM Panel show the same characteristics. Although AE00 provides training on root cause analysis, it is rarely found in these reports. A' prescriptive procedure would require the inspectcr to document the sequence of events, the inmediate causes, the root causes, the consecuences of the event, the itcensees' proposed remediation an< then describe the regulatory violations. This procedure would be used for any materials event, and not just medical events..

4.3 Misadministration Tracking and a National Database database, f misadministration events is being Currently, the bes)"but it"i maintained by'AE00, ~ncomplete. , older data is not as complete as recent data. However, the NRC has not defined what information should be placed in the database.

Since AE00 already has a system in place that can track medical events 13

and is responsible for the Abnormal Occurrence Report to Congress, the AE0lt system should be enhanced and supported to meet NRC's needs. NRC sh tte.not create a new systen., The fields to be placed in the database need to be enhanced to make a database search more useful.

Suggested fields, in addition to the usual date, time and location, might include: treatment modality, consequences to the patient,

, s l

i immediate cause, root cause, enforcement action, and especially the rolevant inspection report numbers where the details of the event and the consultant's report can be found.

Discussions with Agreement States at the 1993 Annual Meeting of the Conference of Radiation Control Programs Directors showed general support for a national database. Discussions centered on aThe system the States, States could access both for input and output by E-mail.

in general, are very receptive to some type of E-mail link to the NRC.

However, a State of New York representative stated that New York was forbidden by State law from revealing the identity of the institution responsible for a misadmicistration. Consequently, the State would provide the NRC with misadministration information, but not the identity of the institution, if the information could be released under the Freedom of Information Act.

5.0 MEDICAL L!CDtSING A2 INSPECTION PROGRAMS 5.1 Size and Scope of t.icensing and Inspection Prograa Overall, the nuclear materials safety program involves about 24 million dollars and 220 FTE (Enclosure 7). Of these, 9.6 million dollars and 112 FTE are in the Regions. The Regicas are responsible for the completion of about $200 Itcensing actions and 2500 inspections a year. Additionally, about 320 licensing actions are the responsibility of HMSS. The budget allows an average of about 20 hours2.314815e-4 days 0.00556 hours 3.306878e-5 weeks 7.61e-6 months per inspection including preparation, performance of the inspection, documentation of the inspection, and completion of the enforcement action'. Resources are also provided separgtely for escalated enforcement actions and response to events. However, expenditures on these activities have historically exceeded budget.

This is particularly evident in Regions I and !!!, which have the largest materials programs.

Similarly, the budget provides about 4.5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months for a license amendment, 8-9 hours for review and issuance of a nee license and about 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months for a license renewal. These data reflect historical expenditure data. There is no explanation of why renewsis take longer to process than new applications. However, license renewal has historically had the lowest priority due to the belief that delays in license renewal have little or no impact on licensees. Currently, there is a significant backlog (i.e., several years) in old renewal applications. Age adds to the length of time needed to complete an 14

action because, with time and changes in requirements, the likelihood of an application becoming deficient increases. The individual submitting the application also may no longer be employed in the same position as when the application was submitted.

- $spw~fs generally no special provision in the budget for new staff.

If there is a hiilh staff turnover, backlogs in inspection and licensing can qu< ckly grow. The materials licensing and inspection program is very production-oriented. The ability to train new staff quickly and to have clear, easily-retrievable procedures and guidance is essential.

5.2 Licensing Guidance 1.icensing Guidance exists both as Regulatory Guides and Industrial and Medical Nuclear Safety Division Policy and Guidance Directives, and HMSS Responses to Regional Technical Assistance Requests.

Currently 12 of 20 materials licensing iluides were issued as a draf t "FOR COMMENT" and have not been issued 'n final form. Most of these were issued in 1985 when materials licensing wat regionalized. Three of these relate directly to medical use, and all three are out of date with respect to 10 CFR Part 35, issued in 1986. Many are out of date due to other changes in regulations. With the revised 10 CFR Part 20 becoming effective in 1994, all will be significantly in error. In addition, a considerable amount of licensing guidance, including information needed by a licensu to properly prepare a license application, exists in the form of Industrial and Medical Nuclear Safety (IMNS) division Policy and Guidance Directives. These documents are essentially internal NRC guidance documents. It is unlikely that a licensee can prepare an acceptable license application without a copy of the appapriate guidance document. Some of these documents are also out of dt.te.

During the NMS$ Regulatory !apact Survey, licensees complained about this situation. They complained that draft Regulatory Guides were not being issued in final form and, therefore, their comments were not being considered. They complained that they did not have a chance to review and comment on the licensing guidance being used by license reviewers and contained in the Policy ard Guidance Directives.

Regional NRC licensing staffs have complained about this problem for at least the last thru years during National Program Reviews and at other times. NMSS staff stated that resource constraints have resulted in this situation and other work has kept guidance revision at a low priority. However, NMS$ receives several hundred Technical Assistance Requests (TARS) per year from the Regions. These generally ask for interpretations of regulations or for specific licensing guidance, and represent a resource burden on MSS that might be avoided if licensing guidance were updated. It should also be noted found that the Office that there was noof the inspector effective General system within (0!G)

HMSS(Case for the93-29A)ing track of 15

requests from NRC Regions for policy guidance or technical assistence.

Some requests have been pending since 1990. There is significant disagreement between the Regions and NNSS about which TAAs are pendLng.

The !!T Report NUREG-1480, identified the fact that the Itcensing guidanceinPolicyandGuidanceDirective(P&GD)FC66-4forHOR Brachytherapy was out of date and that Regulatory Guide 10.8, Guide for the Preparation of Applications for Medical Use, Revision 2, did not t,ddress HOR brachytherapy. An O!G Investigation (Case 93-a) revealed that two license reviewers who acted on the original Oncology Services Corporation license application and an amendment were not even aware of P&GO FC 86-4 when they processed the Itcensing action.

This is a major problem area that must be corrected. Without clear and current licensing guidance, licensees cannot submit applications with reasonable assurance they have provided the information required for licensing. This creates an expense, and results in a d61ay for the licensee in responding to deficiency letters and deficiency phone calls, it creates an expense for the regional staff because they have to issue deficiency letters and may have to send a TAR to NMSS for ,

additional policy guidance. NMSS incurs the expense in responding to i the region's request for guidance. Finally, the hundreds of policy I decisions made by NMSS in the form of TAR responses, whilo being sent i to all the regions, are never consolidated into e,asily retrievable form.

Any All lisandog !utdes must be' updated and issued.la ilnal. forml guidance.neede neluded .in,the. licensing guides and not in Policy and Guidance I Directives., A program is needed to periodically review each licensing guide to incorporata all outstanding TARS and generic correspondence relevant to that type of license.

Appendly B msentgd.,ggal fot;act.eM1A4),nqtJhig tiath.c.This would resu1Cin & DicenUng guides becom' ng ava Table to everyone on a bulletta boardJ The guides would exist in a modular form so that changes would be easy to make. Revision of licensing guides has been discussed with the Office of Nuclear Regulatory Research which has stated that it can only support this effort with technical editors.

The use of Automated Data Processing systems to modularize the licensing guides has been discussed with the Office of Infomation Management Systems, but not in depth. l 5.2.1 License Reviewer Training and Qualification i.astTKGSPTYelaberate.trainhWaind gialificatt'ois program for I l

region 4I,inspectorsisprescriBed',nInspectfenManualChapter(MC) 1245.' ne~itafTar progree was pre 0crL8ed Fnar license 1 J

reviewers untit rmyt.htaL Asars. prescribed in t y g t.9S. p, these coli a am not as rigorous as those fot inapstt Furthemore, with the current lack of codification in

)

16 l

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-_------,--n.,---..-,n. ----,-a.,n.-- .----a....,a-.--n r.~, -

l.

licensing guidance, systematic training of new licensing staff is very difficult.

i 5.2.1 Medical Licensing Actir,nv Reserved for NNS$ Headquarters Currently, the Regions issue all medir.a1 licenses and license

"' amendments. When unique devices or uses appear, the Regions usually request technical assistance from NMSS. This practice needs to be reviewed and revised. When a Region receives a request for a unique medical devien or use, or an acttvity significantly different than one covered by NM$$ generic guidance, procedures should permit a management dects'on to transfer the licensing review to Headquarters.

5.3 Inspection Program The materials inspection program, including that fo9 medical licensees is established in NRC Inspection MC 2800. This procedure categorizes licenses by program codes and establishes inspection priority and inspection frequency. It also provides guidance on initial inspections, unannounced inspections, changes in inspection priority, scheduling of inspections, and adjustments in frequency based on performance, it specifies the inspection procedures to be ussd in conducting materials inspections.

Generally, inspection frequency is based upon risk. The need for a QM Program does not affect inspection frequency. Teletherapy, radiography, broad medical, and large manufacturing and distribution licensees are inspected annually. $nall academic, fixed gauges, in Xilta testing laboratories, small research and development licensees are inspected every five years. Priority 7 licensees, like gas are usually only inspected for cause. The procedure chromatographs,lephone provides for te contacts with general and priority 7 licensees on a generally random basis. Depending on licensee responses, a site inspection may be performed.

There are adjustments needed in the medical area. Teletherapy and broad medical licensees are inspected annually. Most connunity hospitals are inspected every three years, but small institutions and private practice facilities, including therapautic licensecs, are inspected every four years. Recently, a new program code for High Dose Rate Brachytherapy has been established with an annual inspection frequency.

Thatregions tend taLuse discretion in reducing the inspection interval for peer performers, but not to extend inspection intervals for good performers. Representatives of several Regions gave ne particular reason for this. It is likely that an absence of guidance, other than the need to justify eFemplary perfortance, makes the staff reticent to take this step. Examination of the Licensing Management System, also used to track materials inspection, suggests extension occurs in only 1-2 percent of the cases.

17

Although MC 2800 addresses sptcial inspections, this comes near the end of the chapter. This section includes responses to reported Except incidents, follow-up on escalated actions, and allegations.

for incidents, little additional guidance is provided. Detailed

' guidance for incident follow-up is provided in NRC Inspection MC 1301.

This manual chapter provides good, generally detailed guidance for a wide variety of events, including utsadministrations, exposures of workers and the public, and loss of control of material.

The inspection program needs revision and refonnation. Too much emphasis is placed on coupleting the total number of budgeted inspections. The Regional Administrator's performance contract and Regional Operating Plan are strongly driven by numbers of inspections and licensing actions derived from the budgeting process. Inspections of gaugs licensees and amendments to add authorit.ed users count as much as a misadministration inspection or a broadscope ifcense renewal. MC 2800 places greater emphasis on the routine inspection program than on react've inspections.

However, in most % es it is failure to handle reactive events, misadministrations, allegations, and poorly performing licent.ees that causes the Agency to expend considerable resources responding to Congressional inquiries, 1G investigations, and press criticism.

MC 2800 and the Regional Operating Plans must be revised to give top priority to reactive inspections. In the past several years, Operating Plan revisions have given greater emphasis to inspections However,of priority 1, 2, and 3 licenses over lower priority licenses.

The budget numbers program audits continue to emphasize numbers.

should not divert resources into low priority work for the purpose of making the number of completions look good, when higher priority work is left undone or is poorly done.

MC 2800 should be revised to more accurately reflect risk and itcensee performanck. For medical Itcensees, the inspection frequency should reflect the need for correct implementation of a QM Program. Licensee performance should have a greater effect on inspection frequency than is now the case. Resources saved from reduced inspection frequency for good performance can be aplied to weaker licensees. In the case of broadscope licensees, the inspection program could be adjusted two different ways. First, the inspection program can be planned with different areas of emphasis. Completion of all areas would take place over a cycle of several years in order to cover the program in greater This was suggested during the regulatory deperthan is impact survey. now the case.Second, the depth and length of the inspection would then be altered by licensee perfoneance.

The subject of initial inspections and deferral of initial inspections was discussed in 01G audit report g2A-17. This resulted because MC 2800 1acked guidance en deferring inspections when the licensee stated that it did not possess licensed material or engage in licensed activities. This situation would usually occur during an 18

The same audit report attempt to perform an initial inspection.

discussed an inspector's verification of licens u assertions.

Some Agreement States make it a practice to h its duties and responsibilities.

the performance of the initial inspection renardless of whether theT licensee possesses material. The inspector should ensure the be modified to be didactic in nature. licensee has copies of the app Also, the inspector should ensure that and generic correspondence. NRC Form the licensee understands its duties and responsibilities.

591 ifcensedshould behas material modified not beenso that in cases possessed or used,where the licensu the licensee will sta sign a certification to that effect on the Form 591.

Finally, there are changes in licenses through amendments that MC 2800 significantly increase the scope of licensed activities.

needs modification so that for certain major changes, the license is treated as a new license for inspection purposes.

The actual conduct of medical inspections should be chan Currently,The morning. physician may not be at the hospital. The technologist is usually preparing doses, giving doses to patients, or scanning To patients. Inspectors are usually very sensitive to patient care.

avoid review.

impacting patient care, inspectors may concentrat Medical next several years, should focus on program management.

inspection procedures need to be changed to decrease record review, increase assurance that the R50 and Radiation Safety Committees are managing the program, and ensure licensee This may require management some is aware of, an supports, the radiation safety program. Inspections to be announc availabilhy of appropriate licensee staff.

6.0 LICENSEE NANAGEMENT ACCOUNTABILITY Als RA0!ATION RESPONSIBILITY The NRC should concentrate its efforts on ensuring that licensees manage their radiation safety progress and that R10s The and Radiation clinical Safety Committees carry out their responsibilities.

competence of physician users and other allied me This will allow the NRC to State medical licensing authorities. concentrate its expertise in the Current NRC qualification standards in

. radiation safety management.

the medical area need to be radiation safety performance based.

Licensees bear the fundamental responsibility for the safe use of 19 2

e medical radiation. Title 10, Code of Federal Regulations. Part 35, Sections 35.21, 35.22, 35.23 and 35.25 identify ' ndividuals within a licensee's organization who have special responsibilities for radiation safety in the use of licensed material. These sections establish responsibilities and authorities for the RSO, the Radiation

, Safety Conseittee, and authorized users.

However, many of the significant problems identified in medical programs are a consequence of licensee management and RSO failure.

The Commission, in a memorandum dated March 31, 1993, requested a review of this matter (Enclosure 9). The !!T in the Indiana, Pennsylvania, event identified in NUREG-1480, the failure of the licensee's management and the RSO to properly implement a radiation safety program as a major cause of the incident. A review of seven misadministrations by a team directed by the Idaho National Engineering Laboratory (Enclosure 5) found that weakness in organizational policy and procedures directly contributed to all seven misadministrations. Lack of RSO oversight was a significant direct cause in five of the seven misadministrations. The reviews by the QM Committee in HMSS reveal numerous examples of weak to almost non-existent radiation safety programs. Although not resulting in misadministrations, in the past half-year inspectors have found licensees and RS0s that were not even aware of the QM rule. This is over a year after the rule went into effect.

In some institutions that have hired consultants to assist user RS0s, the RSO has essentially delegated the RSO role to the part-time consultant, losing redundancy and day-to-day oversight that is not being,provided by the consultant.

The ACMUI discussed the role and training of the Radiation Safety Officer and physician users at its meeting on May 3 and 4, 1993. It was acknowledged that some individuals named as R50s unwilling physician volunteers, that an individual RSO's job frequently required management skills, and that board certification may not automatically qualify an individual to be an RSO. The panel noted that some training, perhaps only on-the-job training for some programs, was needed beyond board certification to be an RSO. The degree of training was a function of the comalexity of the program. An RSO for a facility, solely doing thyroid tierapy, would not necessarily be qualified to be RSO for a large facility doing external beam therapy and brachytherapy. There was discussion of how one sight test potential RS0s.

HMSShasataskforcetodraftaNUREGon'ManagementofRadiation Safety Programs at Licensed Medical Facilitier. This task forcs includes representatives from MSS, the Regions, and Agreement States.

A manager in one Region suggested third party certification of RS0s.

This would be similar to the ' check pilot

usaJ ny the Federal Aviation Association. This will not solve all the problems, Lowever, because many problems are caused by technica)ly capable individuals betrg either incapable managers or unwilliug RS0s. For many R50s, 20

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l 4

their duties are ancillary assignments. A proposal to raquire all R50s and a corporate official to sign a certification (Appendix C) that the R50 understood his/her responsibilities, was capable of executing them, had the time and resources to perform them, and would

_" be supported by management in the perfomance of the duties, received a mixed reception from the ACMul. About half the committee felt that Part 35 estabitshed the same requirements and it would just be another piece of paper to sign that would be igncred just as easy n the rule.

Problems due to R50s' failure to perform is not limited to the medical area. Part 35 provides the most extenolve uritten description of requirements for the R$0 and the Radiation Safety Connittee. Part 33 has requirements for broadscope licensees, but they are not as strong or detailed as those in Part 35. Thern are no general requirtments for R$0s in Parts-30, 40 or 70. Proposed revisions in 10 C/R Part 34 will define R$0 duties for radiographers.

Reactor Radiation Protection Managers are usually required'to meet certain American National Standards Institute (A41) qualification standards (ANSI 3.1) with certain additions specified in Regulatory Guide 1.B. The reactor approach of using a consonnus standard should be encouraged in the materials area. During the Regulatory Itpact Survey, a 'iconsee noted that the NRC was capable of identifying programmatic fatture but not capable of understanding the root cause of the problem ano fixing it. This is likely to be true in many cases. peer developed R$0 qualification standards incorporated into consensus standards are more likely to be successful and practical than those developed by an NRC staffer without recent practical radiation safety management experience.

The NMS$ task force should continue its efforts. A parallel effort should be established to-examine-current NRC requirements and guidance on the responsibiliti6s of R50s at all facilities. Consideratton should be given to a performance-based rule for all licensees, not just medical licensees. Professional societies should be contacted to-discuss the develope nt of model Radiation Safety Officer qualification standards. In addition, the revision of the inspection 2

program in MC 2800 should include increased emphasis on management control at.G C10 responsibility. Inspection Procedure 87101 already bcludes a Perfo unce Evaluatim Factor program to assess management pc'f37mence. These factors should be reviewed based on recent findings of PTblems resniting in medical misadministrations.

Although receiv>g mixe4 comment from the ACMUI, use of a certif' cation by e R50 and corporate official either on the license application or as a se;nrate fore shm14 be considered. It would make sono reluct M individuals re'use the position ar.d give the NRC greater leverage if a program M found ineffective or grossly t deficient, s

21 i' - - = ..

l 7.0 MEDICAL ACT!0N PL4N/ MEDICAL ACTION !TEMS The staff has received numerous directions from the Commission in addition to is own proposals to improve regulations in the medical area. In his memorandum (Enclosure 8) of May 19, 1993,

" Mr. James M. Taylor, Executive Director for Operations, sent to the Comission the staff's Agenda for improvements in the Medical Use Program. This report sumarized and set priorities for all the issues This agenda was examined identified to date in the medical In area. the addition, Commission presented ten during the current review.

other issues to be considered in an SRM (Enclosure 9) dated March 31, 1993. These issues are listed below in Section 7.1.

I 1

7.1 Specific Commission Issues l

. Consider the advisability of establishing a national database for tracking and evaluation of medical events within the NRC and Agreement State jurisdiction.

This is discussed in Section 4.3. The existing AE00 database of misadministrations can be expanded to accomplish this. A set of essential data elements needs to be defined.

Consider the potential for underreporting of misadministrations.

This is discussed in Section 3.2. Underreporting is most likely if a misadministration is not recognized as such.

Consider possible NRC policies on patient followup.

' A policy on patient followup is proposed in Section 4.2.1 and Appendix A.

Define the appropriate role and responsibilities of the medical .

consultant in NRC medical activities. l l

l The role of the NRC medical consultant has been defined in a l proposed update of Inspection MC 1360 (Aopendix 0). This j document is presently circulating for Office and OGC review. The i attached procedure on sisadministrations (Appendix A) will be made consistent with the final MC 1360.

Consider NRC's role and scope of responsibilities versus that of ths Food and Drug Administration (FDA) and Agreement States in the review and approval of sealed sources and devices.

This item was not reviewed in depth in this report. A Memorandum

' of Understanding with the FDA is currently being developed. In addition, the O'fice of Policy Planning is defining a number of options in response to Senator Glenn. If the current framework of regulation remains, NRC oversight of Agr6ement State reviews 22

16, , -- -- -,.-r-- . , - , --. - - - , m- % y-,----,, - - , . - - - -.,-% ---- -- -- --

needs to be strengthened as discussed in Section 8.2. The results of HRC Human Factors Research on Brachytherapy should be provided to the FDA because current findings show weaknesses in computer controlled devices and control software.

m* Consider the regulatory actions that may be appropriate to better define responsibilities and role of a radiation safety officer (R50) at medical institutions.

This is discussed in-depth in Section 6.0.

Proceed with clarifying amenoments to 10 CFR Part 35 Regulatory Guide 10.8, and internal staff guidance memoranda to clarify the

/ radiation safety requirements applicable to high dose rate remote l

afterloaders.

This is in progress. Oraft internal licensing and inspection guidance has been completed and is being circulated for comment.

Consider the need for modifications or additions to the Enforcement Policy to provide for notifying licensee Boards of Directors or Trustees in cases where escalated enforcement is undertaken by the NRC.

This issue is under consideration by the Office of Enf;rcement staff.

Consider the potential mechanisms for tracking and notifying Agreement States and appropriate licensing /credentialing authorities of problem authorized users, Sncluding chronically careless practitioners as well as wrongdoers.

A memorandum from the OGC dated May 27,1993(Enclosure 10) describes the current system. NRC currently coes about as much as it can legally do without additional rulemaking. Information concerning individuals against whom the NRC has taken an action and given due process of law is being provided to Agreement States. -The creation of additional categories would require rulemaking and some provision to offer hearing rights to an affected <ndividual.

Consider the need to establish procedures under which local authorities including the coroner or medie.a1 examiner would be notified of misadminsstrations or other serious events including potentially significant exposures to radiation or radioactive materials.

Tne utsadministration procedure outlined in Appendix A would provide for this notification to ensure the accuracy of death certificates.

23

.i 7.1 Agenda for Medical Program Improvements AreviewoftheAgendaforMedicalProgramleprovements(Enclosure 8) indicates that a number of the 71 issues can De unified under major areas of progrsa revision discussed earlier in this report. There is

's need to consolidate these issues under the major areas of program revision and create a hierarchy among them since many of the items are interrelated. Twenty issues relate to a general revision of either the inspection program (Section 5.3) or the misadministration followup procedure (Appendix A). Ten issues relate to revisions in licensing guidance ($ection 5.2) and related rulemaking (i.e., Revision of Part 35 to incorporate High Dose Rate Brachytherapy and Camma stereotactic

' surgery, Record Retention, etc.). Ten issues relate to licensee management of radiation use programs and Radiation safety Officer responsibilities (Section 6.0).

Several of the issues involve either ongoing or potential rulemaking.

The major rulemaking issues are: Use and Preparation of f

Radiopharmaceuticals for Diagnosis, Therapy, or Medical Research; The

( Administration of 8yproduct Material or Radiation From Byproduct and Release of MaterialtoPatientsWhoMaybePregnantorNursingl'otherofthe Severa Patients Administered Radioactive Material.

Agenda items may involve revision to 10 CFR Part 35.

The three rulemaking issues above need prompt attention. Time did not permit a detailed review of the three rules for this report. However, consequences of the inadvertent exposure of fetal or neonatal thyroids to radioiodine Lsee-Section 3.4) is suffciently severe to warrant additional,regutatory efforts to protect them. With respect to l

further revisions of 10 CFR Part 35, consideration should be given to l

changing its structare to more readily accosmodate technological changes in medical practice, such as occurred with the introduction of j

the gamma knife and the high dose rate afterloader.

l l_ '8.0 AGREDW STATE 1580t3 8.1 Status There are 29 Agreement States that regulate approximately 15,000 materials licensees. The NRC rwulates about 7,000 licensees of which approximately 2,000 are med< cal licensees. In addition to byproduct material,in generally a similar fashion to byproductAgre ionizing radiation material. In most states, radiation control programs are located '

within State health departments which also regulate the practice of medical arts. The site of the staff with expertise in the materials ,

radiation protection area may be small (two to three persons), in some states, but can be comparable to the materials staff in an NRC region in larger states. Generally, states do not have tha specialists, particularly engineering and dose modeling specialists,_available to 24 k

the NRC. They may have physicians and allied health professionals in other sections of the health department that are not on the NRC staff.

The NRC provides considerable assistance to the Agreement States both directly and indirectly. Direct assistance includes training for

" State regulatory staff provided by both the NRC using NRC staff and contractors paid for by the NRC. For some of this training, the NRC pays State travel and per dies costs. Other direct assistance includes rotations between State and NRC staff for training purposes, consulting activities and, in some circumstances, the use of NRC inspectors and license reviewers from the Regions to assist in State inspection and licensing activities. The NRC provides indirect assistance through its rulemaking activities, regulatory guides, research program, and NUREG pub 1< cations.

The Agreement States provide support to the Office of State Programs in (OSP) through training efforts, by furnishing some instructors and some cases, providing the training facility. Most of the contractor provided training is similar to the technical training provided to the NRC materials inspection and licensing staff. OSP offers "How to Inspect" and 'How to 1.icense" training which is very practical and i includes role playing. Instructors include individuals from OSP, NRC regions, and Agreement States. New NRC inspectors and license reviewers sometimes attend the courses.

OSP also conducts workshops on special topics (e.g., High Dose Rate Brachytherapy) for Agreement State personnel. NRC personnel may also participate in trainSng at these workshops.

Agreement State Programs are expected to be adequate and compatible.

In the medical area (10 CFR Part 35) only the definitions, and the misadministration and QM rules are matters of compatibility. Product evaluations, i.e., evaluations of sealed sources and devices, are Category I indicators. These bear directly on health and safety, but are not matters of compatibility. This area is generally not evaluated in-depth during Agreement State Radiation Control Program reviews, 8.2 Observations and Suggestions The appropriateness of the Agreement States' 1pproving sealed sources and devices for distribution in interstats commerce has been questioned. Section 274 of the Atomic Energy Act states that notwithstanding an agreement, the Commission could require the manufacturer of a device containine byproduct material to have a Commission license. This is a polley decision that needs further evaluation not only for medical devices, but also for both specifically licensed and generally licensed devices. However, if Agreement States are going to approve sealed sources and devices for interstate commerce, their requirements should be a matter of level 2

compatibility. This area also needs greater attention during the State program review. NMS$ would need more resources to support OSP 25

~-

1 in this effort. This would still require fewer NRC resources than would assumption of all distribution licensing by the NRC.

At a meeting with Agreement States representatives to discuss this streno support was received for updating Itcansing

.. guidance.

medical rev'ew,licens'ng NRC guides are used by the States in varying degrees. Some States have formally modified them for their own use.

NRC inspection procedures do not appear to be used as directly by the States.

Agreement States currently regulate a larger n;nber of radiation users, and more diverse radiation sources than the NRC. The States regulation, licensing, and inspection activities are different from the NRC. The concept of federalism, in part, ensisions the States as laboratories for innovation. The NRC should avail itself of the States' experiences. NM55 needs to maintain praater cognizance of Agreement State regulatory activities and uti tre the benefit of State experience. OSP needs to be cognizant of NM55 activities that would be relevant to the States.

l The Agreement States have considerable expertise regulating the medical arts and the use of ionizing radiation in the medical arts.

Caution should be used in making al' of 10 CFR Part 35 a matter of compatibility. Agreement State views on changes in medical or pharmacy regulations can provide information useful to the Comission

' and, coming from a co-regulator, be independent of the regulated comunity.

9.0 INFORMATION MANAGERDif $YSTEMS In addition to the AE00 database discussed in section 4.3, there are a variety of computerized systems which provide information for use by the NMS$ and Regional materials staff. These aret the License Management System (LMS), the Inspection Followup System (IFS), and its predecessor, the 764 database.

In addition, there are two tracking systems currently in use in IMNS for tracking work items related to the medical program. The first of these is "SRAT*, the Medical, Academic and Commercial Use Safety tranch's (IMA8's) Ticket Tracking Program; and the second is the newly created Medical Program Actions System database used to track items -

which have resulted from the Comission Staff Requirements Memorandum of March 31, 1993.

I The current review revealed that these systems as a whole are cumbersome and inadequate to provide the management reports necessary to respond to the serious questions raised recently in Inspector General investigations, in response to the Clevoland Plain Dealer l articles, in preparation for Congressional test < mony, and in response to the General Accounting Office. Even routine information requests 1

' te O

rrwww.es.-em-=* -a-%w.w%ew----nn,vv-=,-------+e---. -*-r - - - - -.--*.----+-r , - - - - - - - + r-- +-- - rr -r ec-, ---- " -

take weeks to process, due to the current format and structure of the information-retrieval systems. This led to an inability of the staff to produce timely and accurate responses to questions about incidents such as the Riverside Hospital eventi led to confusion with respect to the scope of patient notification: and makes it difficult or

- impossible to provide accurate statistical information regarding the frequency and rate of misadministrations. A similar situation exists with respect to tracking allegations. An attempt to determine the percentage of allegations existing in the materials area revealed that the allegations management system does not lend itself to producing direct reports; rather, information must be disaggregated from reactor specific data, thereby greatly reducing its reliabil<ty and utility.

Information management systems in the materials area need to be reviewed and updated. The Division of Industrial and Medical Nuclear Safety needs 1) a Division-level database for work items such as Technical Assistance Requests, to track not only completion, but to evaluate submittal and processing quality: and 2) a database that will permit the tracking of the materials program performance-indicators in NMS$ and the Regions.

10.0 $UMMARY OF RECOMMDSED ACTIONS 10.1 Ensure the Quality Manapquent Program is Implemented by Licensees Quality management programs submitted by licensees must be reviewed for adequacy. Weak procedures and pronrams must be upgraded.

Inspection emphasis must be placed on medical program management and RSO performance.

10.1 Misadministration Fellowup An NRC Management Directive is needed to define the totality of the agency's response to a misadministration. The procedure outlined in Appendix A is recommended.

10.3. Revise Inspection Manual Chapter 2000 10.3.1 Reexamire Inspection Program Priorities in Manual Chapter 2200 Revise Inspection Manual. Chapter 2800 to more accurately reflect risk and licensee performance. The frequency of inspecting medical programs should be based on the need for a quality management' program and should be adjusted for performance.

For broadscope licensees, in general, including medical broadscope licensees, the depth of the inspect'on should be based on performance. Furthermore, in consideration of licensee concerns over the impact of team inspections and in order to

. ensure all. areas are eventually covered in depth, the inspection program for all broadscope licensees should be segmented. In this way, certain areas will be inspected in depth each year. so 27

that over a period of several years the entire program is covered in depth.

Top priority must be given to reactive inspections including misadministrations, allegations, unanticipated radiation I

v. exposures and loss of control over material. The total number of inspections should no longer be used as a primary perfomance indicator in evaluating NAC or Regional performance.

Initial inspections should always be performed even if the licensee does not possess material. Initial inspections should be didactic in nature. NRC Form 591 should be modified so that licensees are required to certify any claim that they do not/have not possessed licensed material nor are they engaged in licensed activities.

Add guidance that puts reinspection on the same schedule as initial inspections after an amendment is issued which substantially increases the licensees' program.

10.3.2 Add Reactive Inspection Procedures

!ssue a special event response insoection procedure to ensure that management can adequately evaluate events with respect to cause and consequences.

Issue an allegation followup inspection procedure and provide investigatory training for inspectors, to improve the quality of allegat'on responses, j 10.3.3 Revise Routine Medical Inspection Procedures f Revise inspection procedure and field notes for HOR and the Gami Stereotactic Device (Gassa Knife).

i Revise general medical inspection procedure and field notes to l reduce the depth of record review, emphasize determination of R50 and authorized user management of program and inspector l communication with hospital administration. l 10.4 Revise Licensing Practices and Guidance Licensing guidance must be updated, consolidated into one set of l documents, and put on a mandated periodic review cycle. Give priority '

to revision of three medical guides. End the practice of putting ]

licensing guidance in internal NRC documents. ;

Complete all licensing actions in a timely manner.

P.evise Inspection MC 1245 to establish a license reviewer training program as comprehensive as that for inspettors, including certifying boards.

28

Ensure Regional TARS are tracked by the Division of Industrial and Medical Nuclear Safety (IMNS).

10.5 Licensee Management Accountability Continue task force efforts to develop a NUREG on Management of Medical Radiation Safety programs.

Consider modification of regulations to address authorized physician user radiation safety train <ng and experience and generically address radiation safety program management and RSO responsibility.

Consider use of the Radiation Safety Officer Certification Form in' Appendix C.

10.5 Tracking Maintain and upgrade AE00's current system for tracking misadministrations. Datermine the information fields needed in the system, including reference to inspection number (s) misadministrations.

Consider providing staff and Agreement States with computer terminal access to the database. Provide the staff and Agreement States a buffered way to enter data into the system.

Enhance and upgrade current information management systems providing infonnation on materials issues.

10.7 Agreement State Issues Agreement State reviews of sealed sources and devices should be a level 2 compatibilit; matter.

The NRC and NMS$ need greater knowledge of Agreement State activities to make use of State experience and innovative ideas.

Ensure the NRC benefits from the fact that in most Agreement States, Radiation Control Programs are in Health Departments with extensive experience regulating medicine and the allied health professions.

11.0 OPEN 135UES Due to time constraints, several issues more remote from the medical area than the issues discussed here, were not reviewed with sufficient depth to make recommendations. Only observations are provided.

29

l 11.1 Enforcement Costs Enclosure 7 Materials escalated enforcement is ntsource intensive.

shows that OE expends 10 FTE on natorials enforcement including

, Headquarters and regional OE FTE. A certain fraction of the 20 FTE expended by OGC is on enforcement. This author's experience is that the Regional technical staff spends at least twice the resourcet on a saterials civil penalty case as the regional and Headquarters OE staff. These individuals must document the inspection, write the violations, write at least a portion of the initial version of the enforcement letter, arrange t.he enforcement meeting with the licensee, conduct the enforcement meeting, document the enforcement meeting, develop a regional position using all the enforcement policy factors and provide, in most cases, all the information OE and OGC need to independently evaluate the region's recommendation.

Since the NRC issues about 60 materials civil penalties a year, it would appear that the NRC's cost of issuing civil penalties, ranging from several hundred to several thousand dollars, is about 0.5 FTE.

This may have recently been somewhat reduced with the increased Regional delegation changes that occurred early in 1993. The costs of enforcement are billeo to the good as well as the poor licensees.

Expenditures of Regional resources on enforcement in excess of resources provided by headquarters forces a reduction in inspections and licensing activities.

11.2 National Program Review / Agreement State Radiation Control Program Review There is currently a Task Force headed by Guy A. Arlotto, Deputy Director of HMSS, reviewing the NRC's Evaluation of the Regional Materials Program and Agreement State Radiation Control Program. As an observation, 8 of the 10 Category I Indicators and 11 of the 19 Category II Indicators used to evaluate Agreement States are applicable, at least in a relative fashion, to evaluation of NRC regional programs. For example, the indicators, Status of Inspection Program and Frequency of Inspection, are directly comparable. The indicator, Inspection Procedures, could become compliant with adequacy of use of Manual Chapter inspection procedures in the case of Regional evaluacions.

11.3 Third Party Certification Third party inspections could be of some value and augment NRC resources. The American College of Nuclear Physicians (ACNP) presented to the ACMUI a description of its Nuclear Medicine Practice Audit Program.- This program reviews aspects of the Itcensee's Quality Assurance program not inspected by the NRC. NCRP Publication No. 99, Ouality Assurance for Dinanostic Isaaina Eautoment, describes steps to be taken to ensure that diagnostic nuclear medicine scans are of the highest possible quality. The NRC does not inspect in this area, but 30 l

l l

I the ACNP program does. It would appear that, for the overall well-being of the patient it is as important that a prescribed scan yields useful information for the radiation dose received as it is to avoid a misadministered dose.

'E Although not discussed in depth, the Agreement States indicated

opposition to third party inspections.

11.4 Length of License Practically, Currently, materials licenses are issued for five years.

since 'ome licenses are under timely renewal for five years or longer, due to lack of HRC resources, one can ask why licenses are not issued This would reduce the renewal burden on for ten years to begin with.One could also require that renewals be the NRC and the licensee.

submitted earlier than the 30 days now required. This would assure licenses are renewed before they expire. During the Regulatory Impact Survey, licensees complained about the added cost to them of the NRC not promptly reviewing license renewals.

This The Agreement States are generally against ten-year licenses.

may be due to their preference for regulation by license condition, rather than by rule. However, there appears to be a diversity in liconse length in Agreement States. One state issues seven-year licenses. Another state issues initial licensees for two years, but renewals are longer.

31 l

4 Appendix A FOLLOWUP ON THERAPEUTIC MISADMINISTRATION REPORTS

+

6

l SCOPE:-

Applies to all events resulting from theracy misaaministrati:ns :r any other medical event including fetal or infant exposures resulting in ar, unplanned or unexpected dose to the patient in excess of Revised Part 20 incident limits. (25 rem effective whole body, 75 rem eye, 250 rads to the skin or an organ.)

I. INVESTIGATION TASKS A. Determine sequence of events.

B. Determine immediate and root causes. )

C. Determine compliance with quality management rule.

D. Dr.termine compliance with misadministration rule.

1. Notification of NRC - 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months .

2. Notification of NRC - 15 days.

C

3. Notification of referring physician and patient - 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months .

4. Written notiftcation of patient - 15 days.

E. Review by NRC medical consultant.

F. Review of enforcement options by NMSS, OE, and Region.

!!. STAFFING A. Inspector qualifications.

1. Senior GG-14 or above.

2. Training in teletherapy, brachytherapy, nuclear medicine.

3. Accident investigation training.

B. Medical consultant.

C. NMSS coordinator.

1. Same qualifications as A. above.

2. Capable of performing dose calculations and evaluations.

3. Maintains file of all medical investigation reports.

4. Coordinates review of event by OGC for final determination of status as misadministration.

Appendix a Page 1

111. MEDICAL CONSULTANT ROLE A. Review event.

... B. Independent analysis of cause.

C. Determine dose to patient.

D. Determine likely medical consequences.

E.

Determine adequacy of licensee report to the NRC and the patient.

F. Determine likely medical followup needed.

G.

If the patient was not notified, determine the validity of the justification.

H.

Provide Medical support to :icensee and referring physician if requested and consistent with the NRC's role as a regulator.

IV. REPORTS A. The investigation report package will include the inspector (s)' report, the medical consultant's report and the Licensee's report to the NRC. Final report is due 15 days after receipt of licensee's and consultant's report.

B. NRC investigation report distribution

1. Licensee

2. Referring Physician

3. Patient or whomever notified by referring physician

4. ACMUI

5. NMSS medical event coordinator V.' FOLLOWUP POLICY A. When misadministrations have occurred the NRC will make reasonable efforts to ensure the patient or an appropriate relative of the patient is informed of the event and the probable consequence of the event.

B. Where the misadministration has recently occurred and what the NRC's role will be in

1. Providing the information from the NRC's inspection and the consultant's report to the patient and the referring physician.

Acceneti Page 2

' - - - - _ - - - _ _ _ _ l

4 I

2. Ensuring the licensee's written report has been provided to the patient and the referring physician.

3. Providing whatever additional medical advice is

"- requested by the patient or the patient's physician and consistent with the NRC's role as a regulatory.

4. Informing patient of DOE's voluntary long-term medical study program.

C. When the event indicates that there has been or may have been misadministrations in the past, the NRC will make a reasonable effort to

1. Identify all patients that received a misadministered dose.

2. Inform all patients or their survivors, if the patient is deceased, of the information available to the NRC.

3. For patients who have died, provide the facts as known to the NRC to the appropriate authorities to ensure the accuracy of death certificates.

D. Upon completion of the above, any enforcement action and followup on licensee corrective actions, NRC involvement will normally cease.

E. In certain cases NRC management may decide that further followup is appropriate in these cases the NRC will issue

' Order (s) to' the licensee to specify the followup information required. These cases-are likely to be situations in which death or severe morbidity are expected by the NRC medical consultant. Since the legal authority for determination of cause of death is usually prescribed by State law, the NRC will bring its information to the appropriate local legal officials charged with this responsibility.

F. Followup reports will receive the same distribution as the original investigation report.

Appendix ;

Page 3

Appendix B LICENSING GUIDE BULLETIN BOARD 3

o S

I

Statement of the Problem:

Licensing Regulatory Guides (RGs) are obsolescent and getting worse eve Furthermore, numerous RGs were issues in draft form for comment and neve revised or issued in final form.Because of the time it takes to issue guides, guidance RG will need revision. including informationHowever, neededeven by these licensees are to prepara lic frequently issued as Policy Guidance and Directive. Frequently regula out of date.

regulations are issued as Information Notices and never issued in a more durable form.

Regions ask specific questions on licensing and inspection matters but the answers have not always been widely disseminated Currently in not have the licensing guides been revised to incorporate specific guidance.

Region Ill, about 20% of all license amendment applications, 30% of all ne license appitcations and 00% of all license renewal applications receive deficiency letters. In Region I, the percentage is significantly greater.

This results in a loss of efficiency for applicants as well as license reviewers'.

Hopefully clearer guidance will increase everyone's efficiency.

Clear and complete guidance is needed to ensure consistency among the Regions and even among license reviewers within a Region considering the degree of staff turnover.

System Design

When Part

1. Computer Based System with the ability to make global ch changed to the new sections in all documents.

Many regulatory guides contain the same material.

2. Modular construction.

Calibration of instruments, components of theup When called radiation safety guide each licensing progrtm, identification of contacts, etc. This would would be created automatically from its modular components revise and (2) a component would be revised and not a whole guide.

3. The system would include all relevant material also needed by lice and license reviewers. These documents would Bulletins, and responses to Task Action Requests.

be guide.

included in modules that would be linked to the relevan pull up all relevant related documents.

4.

There would be a three year review cycle for each licensing guide in which all regulatory changes, relevant information in IN's, Bulletins, and TAR's would be incorporated into the Licensing Guide so the staff and licensees would not have to be aware of informal guidance documents issued 10 years ago.

5.

I envision this system to be initially available to the NRC staff over the LAN. However, I want it designed so that licensee and the public can access.it like a bulletin board. responses to some TARS). In this be accessible to the staff (i.e.,latter case I envision including the NMSS Appendix B Page 1

board.

6.

The system must be user friendly, menu driven (preferably with a mouse provide for read-only access, and include a help menu.

7.

I expeht to have Regional staff contribute to the establishment andI also exp maintenance of the modules in the system. inspection procedures in licensees can conduct self inspections using our procedures.

8.

A contractor is needed to set up this system, to disassemble the existing documents system.

into modular form and to load existing documen contain erroneous information.

Appendix B Page 2

^ _-_

l.

Appendix C RADIATION SAFETY OFFICER CERTIFICATION

. _ _ . _ _ _ . _ _ . . _ _ . . . .._.__m._. _ _ . - _ _ _ . _ _ _ . _ _ . _ . _ _ . ._. _ __.

4 J

RADIATION SAFETY OFFICER CERTIFICATION i

We certify that the individual to be named on this license to perform the function of Radiation Safety Officer as defined in 10 CFR Part 35.21.:-

1. Has read and understands the NRC regulations applicable to this i

license and the specific conditions in the license.

2. Has sufficient technical knowledge to perform the duties of a Radiation Safety Officer,

3. Has and will-continue to have sufficient time to perform the duties 4

of the Radiation Safety Officer,

4. Has and will continue to get_ sufficient resources to accomplish the tasks of the Radiation Safety Officer, j

' 5. Is completely willing to perform the functions of the Radiation Safety Officer, and j

6. Has and will continue to receive the support of the management of this licensee in ensuring that all licensed activities.will be i

i conducted in accordance with NRC regulations and the specific terms of the license.

9 L

Radiation Safety Officer Applicant Date Corporate Officer / Proprietor

' Date

?

i

A0*' O '"0'*;5**, ;*;!

Berre ; .,v e -

UNITED $TATES

[*/.. es :g*ek NUCLEAR REGULATORY COMMISSION Cjs: Taylor 3n102ek j j W ASHINGTON, O C. 20996 B1ana

, 1 December 21, 1992 Knucel g * . . . * ,/ Jordan, AE00 Beckjord, RES oppies or TH, Kamerer, SP scca:TAgy Davis, RIII Vollmer. CPP James M. Taylor MEMORANDUM FOR: Executive Director for op stions Samuel J. Chilk, Secreta FROM:

SUBJECT:

COMIS-92-026 - REVIEW OFhTHE REGULATION OF THE MEDICAL USE OF BYPRODUCT MATERIAL The recent and most serious therapy misadministration incident in Indiana, Pennsylvania, in addition to other recent events and circumstances, has served to highlight the importance of assuring that NRC's medical licensing program is properly designed and ef fectively implemented to provide adequate assurance of public health and safety.

1. The Commission requests that you nominate for Commission approval, a senior NRC manager to perform a management This review of the existing medical use regulatory program.

review should focus on whether our existing programs,is being including oversight of the Agreement state prog. ram, effectively implemented. The review should be coordinated with the management plan (September 8, 1992 Bernero to Taylor memorandua) which is under Thedevelopment, senior managerandshould with any recommendations from the IIT.

identify any recommendations to correct deficiencies in 92003!0 implementation of our existing program. (0E05)

2. To complement this implementation review, the commission is also interested in an in-depth review of the basic regulatory rules, policies, practices and procedures to assess whether our currant framework for medical use of byproduct material is appropriate to fulfill our The statutory responsibilities for public health and safety.

Commission therefore requests that you propose, for Commission approval, a charter and proposed members for an outside group to conduct such a review. The group's membership should provide a-balanced representation of interested and affected parties including some drawn from the medical licensing community. The goal of the group is to develop an assessment of the adequacy and appropriateness of the framework, and to identify specific recommendations for Commission review and action. (NMSS) 3 2 C 3 '. .

M14/] yea-73 L' 2 ,- Enclosure 3

t

3. In performing tasks one and two, the senior NRC manager and(DE05/vS5' the review group should solicit the views of ACMUI, i

The Ciiasission asks that you afford both of these efforts a high i

priority ec: The chairman Commissioner Rogers

' commissioner curtiss commissioner Remick commissioner de Planque

OGC i

F 4

4 t

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JJL 2 719%

ofSciences National Academy,icine Institute of Med ATTN: Ms. Quota Bond Executive Director 2101 Constitution Avenue Washington, DC 20418

Dear Ms. Bond:

Subject:

Statement of Work for an Independent Review and Evaluation Entit

" Review of the Regulation of Medical Use of Byproduct Material" The U.S. Nuclear Regulatory Commissien has completed an internal man review of its program for the medical m cf byproduct material and wish complement this with an independent review and evaluation of the a its replatory program as it is currently implemente risk attendant to tM nedical use of byproduct material.

The objectives and basic areas of interest that the NRC wishes to in this independent review and evaluation are set forth in tne enclose statementofwork(50W).

We hope the National Academy of Sciences Your (NAS) will hav conducting this work.

proposal which would form the basis for discussion In addition, addressing our questions and meeting our contract o explore should also be included in your proposal.

Your proposal should be sent to the U.S. Nuclear Ms. SharonRegulatory O. Nearse, Commiss Division of Contracts and Property Management, ATTNHand-carried proposals should 20555.

Mail Stop P-1042, Washington, DCaddressed in accordance with Avenue, Bethesda, M0 20414.

The proposal shall be signed by an official authorized to bind the shall contain a statement iridicating a proposal acceptsnce period o than 60 days.

This request for a proposal does not commit the Government to pay ir. curred in the submission of proposals.

is the only individual who can legally commit the

~ v M/ A

.2 . :.:M, -

% 2712 QuotaBond s.

Should you have any questions, or wish to have a meeting to discuss the NRC's objectives or our basic areas of interest, please contact Ms. Nearse of my staff on (301) 492-4279.

Sincerely, Ocideal assue ny -

Pa:rteta & g Patricia G. Norry. Director Office of Administration

Enclosure:

As stated Distributionw/ encl.:

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071.t//93 07/M93 7 07/ /93 078/93 (DATE 07/ /93 C= COPY E= COVER /ENCLO5URE MeNO COPY OFFtBIAL RECORD COPY A:\RFPLTR.st S

DRAFT STATEMENT OF WORK

' REVIEW AM EVALUATION OF NRC's MEDICAL USE RESULATORY PROGRAM The purpose of this study is to obtain a comprehensive in-depth review and evaluation of the adequacy of NRC's regulatory program as it is currently implemented to fulfill the agency's statutory responsibilities for protecting public health and safety from undue risk attendant to the medical use of byproduct material, and provide any recomendations for needed changes.

1. The NRC is interested in an examination of the broad policy issues which underlie the regulation of the medical uses of radioisotopes. These issues include:

- the adequacy of the 1979 Medical Use Policy Statement and the consistency of NRC regulations and guidance with the Policy Statement

- the extent of NRC's responsibility to the patient, including notification and followup

- the appropriate role for the NRC medical consultant

- whether the NRC's enforcement policy could more effectively promote better patient care or safer medical user of radioisotopes.

2. The NRC is also interested in an examination of the overall risk context associated with the use of ionizing radiation in medicine, including:

- a comparison between the frequency of errors and consequences associated with the use of licensed byproduct materials and the frequency of errors and consequences from other medical procedures, (e.g., accelerators, chemotherapy, surgery, general anesthesia and administration of drugs).

- a comparison of the frequency of errors and consequ,ences therefree (mortality and morbidity) from the W K iicensed byproduct materials and the rate of mortality and morbidity of properly carried out administrations of licensed byproduct material

3. Finally, the NRC is interested in a critical assessment of the current framework for the regulation of the medical uses of byproduct material, including:

- the appropriateness of the statutory framework, both federal and state, for the regulation of the medical uses of byproduct material, the regulation of other sources of ionizing radiation, and the regulation of devices used in these arenas,

2-

- the spprtpelsteness of the regulatory relationship (s) which

"~ exist among the NRC, the Agreement States, the Food and Drug

Administration and various State boards, Based upon these assessments, provide recommendations for:

- an overall uniform national approach to the regulation of ionizing radiation in medical applications, including a discussion of how the regulatory authority and responsibility for medical devices so be best allocated between the Federal Government and the States.

- appropriate criteria for measuring the effectiveness of the regulatory program (s) for protection of the public health and safety.

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@@ Line 2: / Line 2: @@
 | number = ML20217P394
 | issue date = 12/13/1993
-| title = Responds to 931110 Ltr to Chairman Selin Requesting Any & All Public Documents Related to Senior Mgt Review of NRC Medical Use Program & Proposed Contract W/Nas.Senior Mgt Review Completed in June 1993 by C Paperiello Encl
+| title = Responds to to Chairman Selin Requesting Any & All Public Documents Related to Senior Mgt Review of NRC Medical Use Program & Proposed Contract W/Nas.Senior Mgt Review Completed in June 1993 by C Paperiello Encl
 | author name = Bernero R
 | author affiliation = NRC OFFICE OF NUCLEAR MATERIAL SAFETY &amp; SAFEGUARDS (NMSS)
@@ Line 12: / Line 12: @@
 | case reference number = TASK-TF, TASK-URFO
 | document report number = NUDOCS 9708270434
+| title reference date = 11-10-1993
 | package number = ML20217P392
 | document type = CORRESPONDENCE-LETTERS, OUTGOING CORRESPONDENCE

ML20217P394: Difference between revisions

Latest revision as of 23:01, 20 March 2021

Contents

Text

Dear Dr. Gillin:

Enclosures:

Enclosures:

Enclosures:

Enclosures:

Enclosures:

SUBJECT:

SUMMARY

System Design

SUBJECT:

Dear Ms. Bond:

Subject:

Enclosure:

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ML20217P394: Difference between revisions

Latest revision as of 23:01, 20 March 2021

Text

Dear Dr. Gillin:

Enclosures:

Enclosures:

Enclosures:

Enclosures:

Enclosures:

SUBJECT:

SUMMARY

System Design

SUBJECT:

Dear Ms. Bond:

Subject:

Enclosure:

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