ML20236U763
| ML20236U763 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1986 |
| From: | Mcelroy N NRC |
| To: | |
| Shared Package | |
| ML20235F951 | List:
|
| References | |
| FRN-52FR36942, RULE-PR-35 AC65-1-086, AC65-1-86, PROC-860729, NUDOCS 8712030358 | |
| Download: ML20236U763 (17) | |
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Misadministration Rule Action Plan
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Norman L. McElroy, 396-S5, x74108 Contents Directive NRC Factors Deserving Consideration Other Factors Deserving Consideration Anticipated Products Action Plan Resources Needed References Directive (Memo Stello/Chilk dtd 04/14/86 with all Commissioners agreeing.) " Review the Commission's authority in the area of medical licensee regulation. Prepare a rule to: (1) require independent verification of therapy doses as required for diagnostic doses; and (2) penalize medical licensees or their agents for negligence." (Therapy misadministration is defined at 10 CFR 35.41 as the wrong radio-pharmaceutical or sealed source, the wrong patient, the wrong route, or a dose differing from the prescribed dose by more than 10 percent.) NRC Factors Deserving Consideration
- 1. (Memo Commissioners /C. Bernthal dtd 03-34-86 re "significant medical misadministration of radiation therapy.") " Radiation related injuries to the public from commercial nuclear power plant operations thus far pale in comparison to injuries sustained as a result of medical misadministration of radiation. . . It defies reason that NRC may i penalize licensees for negligent acts which result in the release of no l radioactivity, but apparently has no authority to levy penalties when l l
I 07/29/86 1 MISADMIN RULE PLAN . 8712030358 B71201 PDR PR PDR 1 35 52FR36942
. 'o medical patients are mistakenly. subjected to radiation exposures no member of the public has ever sustained in the operation of commercial nuclear power facilities."
- 2. The Commission may accept a broad quality assurance program requirement that addresses all sources of error and contributing events rather than a simple requirement for " independent verification of therapy doses" as stated in the Commission's directive to the staff. The staff believes a broad requirement will more likely have a beneficial impact on public health and safety than will a requirement that addresses one step in the radiation therapy process. ;
- 3. The Commission may accept a staff recommendation for a negligence clause that has a very high threshold which would only be triggered in rare cases.
- 4. NRC's medical policy statement (44 FR 8242 published 02-09-79) states that:
"1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.
"2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
"3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine."
- 5. NRR has published NUREG/XXXX, "An Investigation of the Contributors to Wrong Unit or Wrong Train Events." The contributors to human error listed therein (specifically: labeling, training / inexperience, procedures, mind I
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,, I .I set,.layolit a,sipmenpfesJga, communications,physiha stressr drawings, interru'ption of work flow, a f rushed) Ire virtually identical to the t ,
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- 6. Staff is trying to arrarise for a clinical practfeum fb\ane hdC staf'f yg '
OJ individualatalocaldedical$stitutiokat00 cost,totheNRC. This t will allow thebtaffj toleartj urrku radiatibn therapy practice before [ ' managing the Nrafti 4 of gpida hefdr'pr p sed regulat' ions. At this 3 time staff is reviewing radiatior#nerapy science, technology and ' )' quality assurance references in preparation for tpa practicum. 4 i f, st,c , ' Lt-
- 7. NRC rulesdng dr,oc'edures require the prert,yation of a " regulatory J analysis" liit'should hrovide a critical,butral analysis of the costs '
andbenefits'of,eachidic. The staff is examining the available
's Y scientif k,Atecture regarding ttp 'esign of qualitf assurance programs. < Y. '
Itisnotclb atthistimewhethebthebenefitofacomprehensive h\ qualityassurahceprogramwculdoytweigh'thecost. ( ef ( , s The radicbon 't'herapy comyunity has he several programs that exarhind a various 9spects of qualit; assurance. ' f{
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The Patterns of Cares ' tudy, pai.d for by tpq f/ tioral Cancer Institute (NCI) was a nationwide multh yeaqstudy o'f kN. Quality of radiation i i I s therapy care. It compared. 'for various kinds of cancer, the quality and '( b ,x v v e accessibility of treatment, how the tre,atment was administered and by ' g )g whom, and evaldated the various\ tactors th't'affected the quality /of I a
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The Radiologic Physics Center (RPC) at thn University of Texas in
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Houston is responsible for qaality assurance in NCI-endorsed national radiotherapy clinical trials that are designed to compare the efficacy of different methods of treating a particular kind of cancer that is at a particular rtage of aievelopnenh, in the stient. It is supported by NCI. It makes site lNsits to rablf..t ion th' a y centers thAt are ! p v c participating in nationaly clinical qtr is a assure that physical measurements and calculaticos are done bf ac gotec procedure. 1) ( 07/29/86 3 MISADMIN RULE PLAN l t C -__ b s
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a, s - l h' The Centers for Radiologic Physics (CRP; six were established nation-wide) were managed by the American Association of Physicists in Medicine ; (AAPM) and funded by NCI, and made site visits to radiation therapy I centers that were participating in NCI-sponsored clinical trials to g assure 4.'at physical measurements and calculations were done by accepted 9 , u n .g , q t
, f proceduie. Funding stopped in April 1986, and the Centers are being "i y disbanded. ; e ,
y' . { \ j k." Other,4ctors Deserving Consideration
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j' 1. The Commission may have to deal with the question, at least peripher- l ally, of khat constitutes a minimum level of quality for radiation therapy care. Small community radiation therapy centers may not have a sufficient patient load over which they can distribute the cost of a comprehensive quality assurance program. Thus they may now be rendering
\ , what some experts would characterize as inadequate radiation therapy care. However, this inadequacy may be balanced by the psychological benefits to the patient of staying in his community and not having to
- i. travel to a large, perhaps impersonal, radiation therapy center in a b 'I
.. f metropol 1;an area to be cared for by strangers. Analysis of the effects.nf these two variables is beyond the ken of the NRC staff (and ,
1 likely, Wl,'s authority), and is perhaps better left to the medical i h community.q However, NRC's operating definition of quality assurance
+ will implyLan %0ency decision on this question. I
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- 2. Under Health Care Financing Administration (HCFA) regulations that direch he method of federal reimbursement for medical care, a hospital
, received a' pre-set fee for each patient's care based on the diagnosis made at the time of admission. The fee schedule may not be subject to o
F e timely rskiew and revision as new costs, such as would be needed to l comp 19 #.th a requirement for " independent verification of therapy l doses," are placed by regulation.
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- 13. If NRC were to " penalize medical licensees or their agents for negli-I \d gence," this may prejudice a person's ability to defend against a negligence lawsuit.
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- 4. The members of certain professional organizations, such as the American a
College of Radiology (ACR) and the American Association of Physicists inMedicine(AAPM),wouldbepersonallyrespen[ibleforactually imp (ep'pptipg a quality assurance program .i;eq@ hunt and would be perse.W,1y affected by any negligence clause. Thus NRC may expect, assistance from those organizations when dr//jting technical requirements,! / Y j
- 5. Other federal organizations, such as the National Cancer Institute and the Center for Devices and Radiologic Health (CDRH), have expertise in the medical use of radiation and shoulc t'e consulted for input.
Anticipated Products
- 1. A regulation that will require that radiation therapy licensees imple-ment a quality assurance program that addresses both radiation therapy procedures and the care of the individual patient. The following general lists apply to both teletherapy and brachytherapy.
i Therapy Process Patient Care Prescription format Referral Chart design Examination Physical measurements of Prescribed dose output and correctioc Localization films factors for beam modiners Dosimetry calculations Treatment planning Set-up Spot checks Daily treatments Physicr1 measurements of Chart checks set-up reproducibility Physician review of Technologist aaily inter- mid-therapy progress action wit. charts, tele- Post-therapy followup therapy unit or :ourcas, and the patient Chart checks Followup 07/29/86 5 MISADMIN RULE PLAN
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- 2. A regulation that establishes a trigger level and penalty for negligence.
Action Plan l Goal: Draft a rule that requires: (1) Radiation therapy quality assurance programs, and (2) Penalties for negligence.
- 1. The NRC will publish an advance notice of proposed rulemaking regarding quality assurance and penalties for negligence.
- 2. The NRC will establish an inter-agency Task Force comprised of l NRC, CDRH, HCFA, ACR, and AAPM and other affected organizations.
I (a) Federal agency representatives will be appointed by appro-priate office directors. (b) Associations will nominate physician and physicist experts for membership on the task force, preferably from the Washington area. NRC will select one physician and one ; physicist and retain them as consultants for this project.
- 3. The Task Force will prepare two documents.
(a) A model radiation therapy quality assurance program for teletherapy and brachytherapy; and (b) Guidance regarding quality assurance and negligence l regulations. 1
- 4. NRC staff will plan publication of the quality assurance program as a NUREG or draft regulatory guide and will prepare a Commission Paper !
and Notice of Proposed Rulemaking based on the Task Force guidance. 1 07/29/86 6 MISADMIN RULE PLAN
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- 5. NRC ~ staff will forward both products from s'.ep 3 to the Commission for approval by 04-15-87.
Resources Needed' l
- 1. NRC Staff (a) NRC lead staff.
(i) One professional is needed to chair the Task Force and manage the project. This will require 0.3 SY in FYS6 and 0.5 SY in FY87. (ii) One secretary is needed for preparing correspondence, ' reports, and NRC documents, managing meeting arrange-ments and preparing NRC forms for' reimbursement of consultants. This will require 0.3 SY in FY86 and 0.5 SY in FY87. (b) NRC cognizant staff. ELD, IE, RES, and AE00 will each have to supply 0.2 SY in FY86 and 0.2 SY in FY87.
- 2. Travel. If the paid consultants reside in the Washington area, only local travel expenses will be incurred.
- 3. Consultant fees.
(a) One physician will be needed for two months in FY86 and two months in FY87. One physicist will be needed for four months in FY86 and four months in FY87. (b) If one month costs $10k, consultant fees will be about $120k. i l 07/29/86 7 MISADMIN RULE PLAN
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E . l l References , l 0 Medical Policy Statement, NRC, 44 FR 8242, published February 9, 1979. l Technological Basis of Radiation Therapy: Practical Clinical Applications, by S. H. Levitt and N. D. Tapley, Lea & Febiger, Philadelphia, 1984. Introduction to Human Disease, by T. H. Kent, M. N. Hart, and T. K. Shires, Appleton-Century-Crofts, New York,1979. Clinical Oncology /A Multidisciplinary Approach, 6th. Ed., P. Rubin ed., American Cancer Society, 1983. The Physics of Radiology 3rd. ed., H.E. Johns and J. R. Cunningham, Charles C. Thomas, Springfield,1969. CRC Handbook of Medical Physics v III, R. G. Waggener, J. G. Kereiakes, and R. J. Shalek, eds., CRC Press, Boca Raton, 1984. Therapy Misadministration Reported to the NRC, NRC Office for Analysis and Evaluation of Operational Data, No. AE0D/C505, December 1985. Improving Quality in the Nuclear Industry (Conference Proceedings), R. C. Stinson, Genc-al Chairman, American Nuclear Society, La Grange Park, 1982. Quality Assurance in Radiation Therapy /A Manual for Technologists, M. J. Wizenberg, Chairman, American College of Radiology, Chicago,1982. AAPM Report No. 13, Physical Aspects of Quality Assurance in Radiation Therapy, G. K' Svenson, Chairman, American Association of Physicists in Medicine, New York, 1984. Criteria for Radiation Oncology in Multidisciplinary Cancer Management, W. E. Powers, Chairman, National Cancer Institute, 1981. 07/29/86 8 MISADMIN RULE PLAN
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Quality Assurance in Radiation Therapy: Clinical and Physical _ Aspects (Conference Proceedings), G. E. Hanks, Chairman, Pergamon Press, New York, 1983. l Qualifications of Inspection, Examination, and Testing Personnel for Nuclear ! Power Plants, ANSI /ASME N45.2.6-1978, American Society of Mechanical
- l. Engineers, New York, 1978.
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Roe pf)g N O T ATIO N 7 RESPONSE SHEET
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- I'O: Samuel J. Chilk, Secretary of the Commission 'C"h*
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'3UBJECT: Mercy Hospital, Wilkes(SECY PAPERand 86-141) (81 Va Actions For (A)lley Radiol Proposed Enforcement Barre, Pennsylvania Associates, Inc., Kingston, Pennsylvania APPROVED V DISAPPROVED ABSTAIN
- NOT PARTICIPATING REQUEST DISCUSSION /OTHER ACTION Comments
' Sse attached comments A . f co w cv. p. SIGNATURE h C 2-4-g Entered into VTS Yes >( No DATE _ _ _ _ _ . _ _ _ _ _ _ _ _ . _ _ _ l
r O Commissioner Zech's comments on SECY 86-141 This paper raises the issue _of the system wa have to identify and inform others of individuals who have committed violations under a materials license and who subsequently leave to go elsewhere. Presumably, but for the individuals voluntary departure, the individual would have been prohibited from engaging in certain activities under the license. Although I am not suggesting a permanent har or a " prohibitive list," I wonder what system we have in place to assure that an indiviannt under such circumstances simply does not leave and ao to anothnr licensee _(NRC or agreement state) and continue to engage in similar activities. In any event, I think that we should have a staff report on this. 4 4
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RESPONSE SHEET G cow-hem l J.De>6 T0: SAMUEL J. CHILK., SECRETARY OF THE COMMISSION FROM: COMMISSIONER BERNTHAL
SUBJECT:
SECY-86-141 - PROPOSED ENFORCEMENT ACTIONS FOR MERCY HOSPITAL, WILKES BARRE, PENNSYLVANIA AND VALLEY RADIOLOGY ASSOCIATES, INC., KINGSTON, PENNSYLVANIA APPROVED DISAPPROVED ABSTAIN NOT.. PARTICIPATING REQUEST DISCUSSION COMMENTS: T m y_ w k r 4C - C ~ ~+
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YES NO p Entered on "AS" / / / / / USIV SECRETARIAT NOTE: PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER. NRC-SECY FORM DEC. 80 -
cc: Stello Roe N OT A T I O N V0TE 7, qq RESPONSE SHEET C CUmhm ! 19 T0: SAMUEL J. CHILK, SECRETARY OF THE COMMSSION 'h FROM: CHAIRMAN PALLADINO
SUBJECT:
SECY-86-141 - PROPOSED ENFORCEMENT ACTIONS FOR MERCY HOSPITAL, WILKES BARRE, PENNSYLVANIA AND VALLEY RADIOLOGY ASSOCIATES, INC., KINGSTON, PENNSYLVANIA X APPROVED DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION- : COMENTS: Agree with JKA and LZ comments. d a4 v#
/ bl6NAIURL YES NO ( ' .2 ' [ I Entered on "AS" / / / USIE SECRETARIAT NOTE: PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER.
NRC-SECY FORM DEC. 80 -
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6. T0: S/AUEL 3. CHILK, SECRETARY OF THE COMMISSION / FROM: COMMISSIONER ASSELSTINE' SUBJECT *. SEcY-86-141 - raoroSED ENeoncEnENT ACTIONS roa sEacY HOSPITAL, WILKES BARRE, PENNSYLVANIA AND VALLEY RADIOLOGY ASSOCIATES, INC., KINGSTON, PENNSYLVANIA APPROVED x DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION 1 COMMENTS: If nodified as attached. , i l l I 1 l 4 " j W use YEF NO l 5/20/86 Entered on "AS" / / UAIE SECRETARIAT NOTE: PLEASE ALSO RESPOND TO AND/OR COMMENT ON OGC/0PE MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAPER. NRC-SECY FORM DEC. 80 l
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,. j SECY 86-141 L I do not believe that either the Severity Level or the amount of the civil penalty is appropriat.e in this case. The physician in charge )
' knowingly failed to report a misadministration to the NRC. Then when {
- l. the NRC inspectors asked about misadministration a representative of the hospital knowingly and wilfully lied to the inspectors. This conduct warrants more than Severity Level III and a $2500.00 fine. I' would raise the severity level to I and. assess a civil-penalty of $5000 which is the base civil penalty for that severity level.
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cc: Stello
*' Roe N 0T'4 T I 0 N V0TE 3.ThULcIL RESPONSE SHEET q,y yd Is T0: SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM: COMMISSIONER ROBER1S SECY 41 - PR P SED ENF RCEMENT A TI NS FOR MERCY SUB E T-' HOSPITAL, WILKES BARRE, PENNSYLVANIA AND VALLEY RADIOLOGY ASSOCIATES, INC., KINGSTON, PENNSYLVANIA DISAPPROVED ABSTAIN APPROVED ,
NOT PARTICIPATING REQUEST DISCUSSION _ ! COMMENTS: 1 Si~NAlupt. YES NO fp Entered on "AS" / / / / / ljAlt SECRETARIAT NOTE: PLEASEALSORESPONDTOAND/0R.COMMENTONOGC[0P MEMORANDUM IF ONE HAS BEEN ISSUED ON THIS PAP,R. E NRC-SECY FORM DEC, 80 -
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- Telephone interviews with NRR Human Factors people.
Bill Russell 4-16-86. We are developing an investigation protocol on examining 1 i human errors. Title is wrong unit / wrong train. Causes are labeling, training, ' and procedures.- Also cognitive errors. industry needs writers and guides. i There .is currently no enforcement action against operator usually unless he l 1s individually culpable with reckless disregard or deliherate. We have " blacklisted" that is, removed individuals from regulated activities, but provide steps necessary to be reinstated. Steve Burns ELD 4-17-86. If an operator screws up we take enforcement action , usually against the facility (the Reg Administrator or J. Taylor signs it out). We may attribute to human error, poor training, but no direct enforcement action against the operator usually. The licensee may take disciplinary action orpwv/b training for operator. There is no action or citation if there was no violation (unless a~ gross error where we can issue an order. Such events are rare'.) Bill Brach IE Reactors 4-18-86 The licensee is responsible unless there is complete dereliction by the operator (only twice in memorable history, dealt with by letter to the operator's file). Usually as any action, "due to personnel error, the licensee. . ." Severity level III. We review licensee event reports for personnel errors (licensee usually finds it first, but has already fixed it by the time of the enforcementconference). Operator action would require falsification or gross negligence. Jay Persinski 5-02-86 Verfiedfme% formation.}}