ML20127H497

Provides Commission W/Info About Status of National Medical Use Program,Re Prevention of Serious Radiation Injury or Death Caused by Medical Misadministration & Current Activities Related to Aspect of Regulatory Program

ML20127H497
Person / Time
Issue date:	01/19/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-93-007, SECY-93-7, NUDOCS 9301220346
Download: ML20127H497 (120)

Text

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• 't , 0 p4f.....y,S January 19, 1993 POLICY ISSUE sscy_,3_oo, (Information)

For: The Commissioners From: James M. Taylor Executive Director for Operations lubject.- ASPECTS OF THE NATIONAL MEDICAL USE PROGRAM RELATED TO -,

PREVENTION OF MISADMINISTRATIONS

Purpose:

T- provide the Commission with information about the status of the national (NRC and Agreement States) medical use procram, regarding prevention of serious radiation injury or ceath caused by medical misadministrations, and current cctivities related to this aspect of its regulatory program.

Particular attention is directed toward medical radioisotope therapy as the principal practice in which serious radiation injury or death has been observed.

Summary: This paper provides background and discusses issues associated with the current national material regulatory practice for those aspects of the medical use program related to prevention cf misadministrations. Several major issues, currently under review by NRC and Agreement State staffs, were recently raised in a series of articles, dated December 13-17, 1992, in the Cleveland Plain Dealer and are discussed herein with associated implications. These include: 1) effectiveness of NRC's and Agreement States' oversight of medical use of byproduct material; 2) followup of patients subject to misadministrations; and 3) expansion Contacts:

John E. G1enn, NMSS NOTE: TO BE MADE PUBLICLY AVAILABLE 504-3418 AT COMMISSION MEETING ON 1/22/93 Vandy L. Miller, OSP 504-2326 0 '

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The Commissioners 2 of NRC's regulatory purview. Other program areas discussed are: training and qualifications and NRC budget resources for NRC and Agreement State personnel involved in the medical use program; and NRC's and Agreement States' inspection, enforcement, and investigation activities. A brief description of the staff medical management plan as i well as the goals of two independent audits, internal and l external, of the medical use program is provided. The staff l has provided preliminary observations and recommendations on j specific issues for future consideration. l l

Backaround: NRC currently administers approximately 2000 licenses for the possession and use of byproduct materials for medical tpplications, and Agreement States administer approximately 4500-licenses. The medical use of byproduct material has experienced infrequent overexposures of patients resulting in deterministic health effects; NRC medical consultants concluded that some of these misadministrations directly resulted in or contributed to the cause of death. These incidents have occurred in radioisotope therapy (i.e.,

teletherapy, brachytherapy, and radiopharmaceutical therapy) and with diagnostic uses of iodine-131 in excess of 30 microcuries. A staff summary regarding NRC-confirmed patient deaths associated with radiation overexposure has been transmitted to the Commission in a memorandum dated January 8, 1993, entitled " Patient Deaths Attributed to Medical Radiation Exposure."

The medical application of radioactive material for therapy may involve the deliberate exposure of individuals to high doses of radiation (e.g., 5000 rad to a tumor' volume).

Errors in the administration of a therapeutic quantity of radioactive material can result in misadministrations to the patient, as well as unintended exposure of licensee personnel and members of tne general public. - The causes of tim.. aisadministrations may be characterized by insufficient supervision, deficient procedures or failure to follow procedures, inattention to detail, and inadequate training. Over the years, NRC has modified its medical use regulatory program to add specific requirements and to increase its oversight to reduce the likelihood of misadministrations. Two of these requirements, the 1987 misadministration reporting criteria and the 1992 quality management program and misadministration rule, are a matter of compatibility for Agreement States.

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The Commissioners 3 KEY MILESTONES IN THE DEVELOPMENT OF THE CURRENT REGULATORY PROGRAM TO HELP RECUCE THE LIKEllH000 0F OCCURRENCE OF MISADMINISTRATIONS:

In SECY-92-175, " Annual Report on Medical Use Program," the staff identified several key milestones or turning points in the evolution of the entire medical use program.

Specifically, the following three milestones reflect NRC's policy and requirements for the identification and reduction of errors resulting in misadministrations.

o 1979 Medical Policy Statement This policy addresses the Commission's general intention regarding the regulation of the medical uses of radioisotopes. The Commission stated: 1) 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) 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; and 3) NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine. The Commission applies this policy to development of regulations governing the medical use program, licensing, and to the development of related inspection and enforcement policies, although the final regulations take -precedence over the policy statement.

o Misadministration Reportino RecuiremerAs NRC published a proposed rule, in 1973, .to _ require misadministration reporting. Between 1976 and 1979, NRC staff was made aware of several incidents, some of which contributed to deaths of patients. Because of an error by licensee personnel in the calibration of a teletherapy unit at Riverside Methodist Hospital in Columbus, Ohio, more than 400 individuals were exposed. These incidents ranged from minor to serious errors involving teletherapy and brachytherapy applications, in response, NRC amended its regulations to require activities intended to reduce the likelihood of occurrence of errors. These amendments included: 1) a rule to require annual calibration and monthly spot-checks of teletherapy units (44 FR 1722); and

2) a rule requiring surveys of patients after tne removal of temporary implants (43 FR 55345). The Agreement States were encouraged to adopt these regulations, but no degree I

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of uniformity between NRC and the States was required. The Conference:of Radiation Control Program Directors, Inc. has developed suggested State Regulations and a number of Agreement States have adopted them into their rules.

The 1973 proposed rule to require misadministration reporting was withdrawn because of the elapsed time, and another proposed rule was published in 1978. The final misadministration reporting rule became effective in Nc/ ember 1980. For various reasons, including the different methods of enacting State regulations, this rule was not made a matter of compatibility for the Agreement States.

The rule required misadministration reporting and recordkeeping and, for therapy misadministrations, notification of the referring physician and patient or responsible relative (or guardian), unless the referring physician personally informed the licensee either that he would inform the patient, or that, in his medical judgment, telling the patient or patient's responsible relative (or guardian) would be harmful to one or the other, respectively. The Commission's stated purpose in requiring misadministration reports to NRC was to identify their causes in order to correct them and prevent their recurrence. This would be accomplished by notifying other licensees of generic issues, and, if appropriate, changing NRC regulations to prevent specific types of errors. In addition, the Commission noted that the misadministration recordkeeping and reporting requirement was necessary to protect patients and stressed the importance of notification of the referring physician and patient.

In 1986, 10 CFR Part 35 was revised (effective April 1987),

which included a change in the criteria for reporting diagnostic misadministrations. This revised rule was the first time misadrainistration reporting was made a matter of compatibility for Agreement States, effective April 1990.

The " Quality Management Program and Misadministration" rule, which became effective on January 27, 1992, revised the definition of, and reporting requirements for, diagnostic and therapeutic misadministrations of byproduct material.

The Commission restated the impartance of the requirement to notify the patients so that tney, in consultation with their personal physician, are allowed to make timely decisions regarding remedial and prospective health care. The January 1992 revised rule will become a requirement for compatibility for Agreement States in January 1995. Results of misadministration analyses have t 2en published in NRC reports and information notices, summarized in medical publications and discussed in workshops with NRC medical licensees and Agreement States.

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't The Commissioners 5 Enclosure 1 contains statistical information on the types (i.e., diagnostic and therapeutic) and number of misadministrations for different categories of NRC licensees (1989-1991). Over this period the number of diagnostic misadministrations reported by NRC l_icensees has remained essentially constant. Over the past 10 years, the average number of reported diagnostic misadministrations was 403 per year. Reported therapeutic misadministrations, however, increased from 10 in 1989 to 24 in 1990, and then declined to 19 in 1991. The 1990 and 1991 numbrs are higher than the 10-year average of 11 per year, cited in NUREG-1272,

" Office for Analysis and Evaluation of Operational Data 1991 Annual Report." As noted in SECY-91-139 (Enclosure 2), this increase could be attributed to several factors, including:

(1) an increase in the number of new ano complex brachytherapy procedures performed, including remote afterloading procedures; (2) increased licensee awareness of -

NRC reporting criteria and the importance of timely reporting; and (3) escalated enforcement actions against licensees for failure to report. Although the data have not been characterized in this paper, a detailed analysis of trends in, and causes of,. misadministrations, was previously discussed in enclosure 1 of SECY-91-139. -In addition, enclosure 3 provides the 1991 misadministration information, for four categories of licensees, by individual State.

o 1992 Ouality Manaaement Proaram and Misadministration Rule NRC amended its regulations, effective January 27, 1992, to require implementation of a quality management (QM) program, to provide high confidence that byproduct material or radiation from byproduct mater _ial is administered as directed by an authorized user physician. The performance-based rule was to enhance patient safety while allowing the flexibility necessary for proper medical care. The rule amended regulations for therapeutic administrations of radiopharmaceuticals, therapeutic application of radiation from sealed sources, and the administraticn of radioactive sodium iodide. Licensees are required to have written policies and procedures to meet five specific objectives:

1) that, prior to administration, a written directive is prepared; 2) that, prior to each administration, the.

patient's identity is verified by more than one method as the individual named in the written directive; 3) that final-plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in-accordance with the respective written directives; 4) that each administration is in accordance

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The Commissioners 6 with the written directive; and 5) that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

Discussion: CURRENT ISSUES AND REGUl.ATORY PRACTICE:

o Cleveland Plain Dealer Series The series of articles in the Cleveland Elgjn Dealer raised the question of the extent of NRC's and Agreement States' knowledge of incidents as well as several major issues currently under review by NRC including: A) effectiveness of NRC's oversight; B) followup of patients subject to misadministrations; and C) expansion of NRC's regulatory purview. The articles allege that NRC was unaware of the extent of some misadministrations (and/or failed to take appropriate actions in response) in which deaths and serious-injuries resulted. Enclosure 4 contains a summary of reports on the incidents identified in the Plain Dealer series. That analysis provides information, regarding licensees under NRC and Agreement State purview, on each incident that identified a patient in addition to any followup action taken by NRC and the licensee.

A. NRC Oversicht The Cleveland Plain Dealer articles criticized NRC for devoting only a small percentage of resources to' the medical use program. Further, the Plain Dealer concluded that fines are low and doctors implicated in criminal conduct are not disciplined. NRC licensees w re accused of not reporting misadministrations in the tima required by the regulations.

Also, it is. stated that NRC and Agreement States often fail to share information.

NRC exercises oversight of r.edical use licensees through its inspection and enforcement of licensee irplementation and compliance with its regulatory program, ilRC does not have direct management control or day-to-day contact with medical licensees. The following paragraphs discuss the application of NRC and Agreement. States resources to oversight of medical activities.

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1. Trainina and Oualifications of Personnel and _ )udget Resources NRC Medical Use Proaram: The.FJ93 nuclear materi ils safety budget includes 41 direct staff full-time equiva ents (FTE) involving effort-by 74 staff individuals arJ $1000K in program support funding, to support medical progt im activities. The program currently includes 74 ti chnical staff professionals exclusive of managerial posi' ions, nearly all of whom have bachelor.'s degrees,- prir arily in health physics or radiation protection; 22 have master's degrees; and an additional 8 have doctoral drsrees.

Approximately half of the staff have prior '.ork experience in a medical program. The staff has, on-a,erage, 6.1/2 years of NRC experience. In addition, jo'i-related didactic technical training is provided to NRC str.ff and may include:

1) general health physics; 2) diagnostir, and therapeutic nuclear medicine; 3) teletherapy and brachytherapy; 4) whole body counting / internal dosimetry; and 5) _ inspection procedures.-

NRC nuclear materials license reviewers and inspectors are expected to complete a regional journal before they are given their licensing signature authority or-inspector qualifications. These journals typically include sections-covering: 1) administrative matters; 2) relevant parts of the Code of Federal Reaulations; 3) the Atomic Energy: Act and Energy Reorganization Act;'4) the NRC Inspection Manual (focus on nuclear material program); and 5) relevant

" Standard Review Plans."

New licensing reviewers receive direction and review from senior reviewers and supervisors in their earliest-assignments. -Licensing signature authority is granted after a sufficient number of. assisted and independent reviews for each of the various categories of materials licensees.

Similarly, junior inspectors initially accompany senior inspectors as part of the qualification process to conduct independent inspections.

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' This number includes one Medical Visiting Fellow.

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Aareement State Program': Commission training for States was specifically authorized by Congress in 1959, when Section 274 of the Atomic Energy Act was enacted and signed into law. Congress recognized such training was needed to  :

assist States to prepare for entering into an Agreement with the Atomic Energy Commission (now NRC) and to maintain programs that are adequate to protect public health and safety and are compatible with the NRC's program.

State radiation control personnel regularly attend NRC-sponsored training, to improve their technical and administrative skills and, thus, their ability to maintain high quality regulatory programs. In FY87, NRC provided training to. students in its State training program with a budget of 5522,000. In FY92, NRC budgeted 5816,000 for State training. The need for this training has increased as the number of Agreement States has increased, as more States express an interest in becoming an Agreement State, as changes in technology regarding use of radioactive materials and new regulatory initiatives are being developed, and as staff turnover occurs (enclosure 5 provides the annual training budget and the nuinber of State personnel trained -

.eachyear).

NRC training for States includes: 1) basic training in the fundamentals of radiation protection; and 2) procedural instruction in licensing, inspection, and other radiation-protection regulatory activities. NRC offers courses such as " Health Physics" (5 weeks), " Radiation Protection Engineering", and " Medical Uses of Radionuclides." In addition, workshops are conducted throughout the year, as -

the need arises, in special topics, such as radiophamacy _

rulemaking, patient release criteria, extension of QM rule to pregnancy and breastfeeding, and low-level waste-(LLW) -3 regulation. Improvements and new initiatives in the NRC materials program (such as Part 20, Part 35 and LLW) necessitate an increased need for training of Agreement State staff, as well as NRC staff. >

Several courses are held jointly with NRC staff, to allow -

licensing and inspection personnel from Federal and State-government to exchange information and experience. Some of the courses are contracted for and others are developed and presented by the Office of State Programs (OSP) staff, with

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2 The discussions regarding Agreement States is of the materials program

! as a whole and not specific to the medical use program, unless otherwise I stated.

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the assistance of other NRC and_ Agreement State staff (e.g.,

" Licensing" and " Inspection Procedures").

Agreement States do not depend solely on NRC for training of staff. States provide on-the-job training for their staff in areas such as administrative practices, radiation control, radiological emergency training, and LLW disposal.

In addition, training courses provided by the Environmental Protection Agency, the Food and Drug Administration (FDA),

and the Federal Emergency Management Agency are used by State Radiation Control Programs whenever possible; however, other Federal agency training has limited applicability to Agreement State programs, in addition,_some State employees accompany other Agreement States on inspections, or visit NRC headquarters or NRC regional offices, to obtain on-the-job training in the licensing and inspection of radioactive materials.

State in-house training efforts are neither substitutes for, nor duplications of, NRC training. They are mutually complementary. Taken as an integrated whole, the training helps ensure that State staffs are suitably qualified to carry out Agreement State programs in accordance with the Commission Policy Statement for adequacy to protect public health and safety.

Qualifications of Aareement State Staff: NRC guidelines call for professional staff in the Agreement States to hold a bachelor's degree or equivalent training in the physical and/or life sciences. Additional _ training and experience in radiation protection for senior personnel, including the director of the radiation protection program, should be commensurate with the type of licenses issued and inspected by the State. All of the Agreement State program managers or others in key positions (Program Director, (Program Administrator, and Division Chiefs) have bachelor's degrees-in the physical and/or life sciences; 19 have Master's degrees; and 7 have doctoral degrees. At the time an agreement is signed, all qualifications of the Agreement State staff, including applicable course work, are listed in the Federal Reaister. As part of their initial training, new State inspectors are a: companied by NRC. staff. In addition, NRC examines qualifications of the new staff and recommends additional training in certain areas, as appropriate.

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2. Insnect wn Activities The purpose of inspections is to determine if licensed -

programs are conducted in accordance with NRC requirements-and specific provisions of the license, and if. licensed <

activities are conducted in a manner that will-ensure the health and safety of workers and the general public.

Inspectors are instructed to ascertain compliance by direct observation of work activities, interviews with workers, and observation of workers performing tasks regulated by NRC (e.g., radiation surveys). Additionally, information in licensee records is reviewed to determine compliance with recordkeeping and other. requirements.

Currently, each licensed program is categorized by a program code, which determine:. the priority, or frequency of routine unannounced inspections. In addition, announced or unannounced special inspections may be performed to determine the circumstances surrounding a particular incident. The inspection frequency for medical use licensees varies from once each year (e.g., broad-scope medical programs) to once every 4 years (e.g., private practice-cu: tom) depending on the scope of the licensed program. Generally, the larger the scope of, or the more hazardous the licensed activities, the more frequent the inspection.

Inspection frequency is also a function of availatile financial and personnel resources, and thus is periodically re-evaluated. Therefore, refocusing inspection d arts by-increasing inspection frequency for certain program codes.

requires additional resources for implementation. Enclosure 1 presents data, for 1989-91,- on the number of licenses, inspection frequency, number of inspections, and number of diagnostic and therapeutic misadministrations for the four major categories of- medical licenses: medical broad-scope licenses; community hospitals; private practices and clinics; and teletherapy licenses. Over this period,.the number of medical licenses in these four categories declined by 3 percent from.2252 licenses to 2186 licenses.- Since-1991, the number of these-licenses has declined an additio_nal 8 percent to 2002 licenses (the staff notes. that the amendment of 10 CFR Part-171 to accommodate full-cost recovery was implemented-in 1991 and may have contributed to this decrease). The inspection frequency was increased for most major categories of medical licensees in 1989 and for community hospitals in 1991. The number of inspections conducted by NRC staff for broad scope, community hospital,

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The Commissioners 11 private practice / clinics, and teletherapy licenses increased by 30 percent from 859 inspections in 1989 to 1118 inspections in 1991.

Aareement State Proaram: In general, the 29 Agreement State.

Radiation Control Programs (RCPs) maintain an inspection program adequate to assess licensee compliance with State regulations and license conditions. The-RCP maintain statistics which are adequate to permit Program Management-to assess the status of the inspection program on a periodic basis. There is at least semiannual inspection planning for-the number of inspections to be performed, assignments to senior and junior staff, assignments to regions, identification of special needs and periodic status reports.

When backlogs occur, the Programs develop and implement-plans to reduce the backlog. The plans identify priorities for inspections and establish target dates and milestones for assessing progress. The plans are reviewed by OSP staff. With regards to inspection. frequency, the Agreement States must inspect at a frequency that is no less than NRC.

In addition, some Agreement States inspect more frequently than NRC. Enclosure 1 also presents data on-the number of licenses and number of inspections in Agreement States.

3. Enforcement and Investiaation Activities The purpose for taking enforcement actions against medical licensees is the same as for other NRC licensees and is described in-the NRC Enforcement Policy. There are two primary purposes for' escalated enforcement actions: 1) to encourage the prompt identification and lasting correction of violations; and 2) to deter violations from initially occurring. An enforcement program with deterrence, including sanctions and the associated negative publicity, ,

is important because it may-provide an incentive to a licensee to expend the effort and resources to improve its performance in advance of an NRC inspection.

A graduated approach to-sanctions is used, based on the Severity levels of the violations which are described in section IV of the Enforcement Policy and its eight-supplements. The threshold for taking escalated enforcement action is generally any violation categorized at; Severity Level III. In the medical area, this Severity Level is frequently reached, based on: -overexposures or subst3ntial potential for an overexposure; loss of control or impraper disposal of other than insignificant types or quantities- of radioactive material; misadministrations resulting from

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failure to follow the procedures of the QM program or failure to report a misadministration; breakdown in the control of licensed activities based on recurring violations or numerous violations that demonstrate a lack of attention to licensed activities; or willful violations. These types of violations are described in the examples found in Supplements IV, VI, and Vil of the Enforcement Policy.

Enclosure 6 contains statistics for escalated enforcement cases for Calendar Years 1989-1991.

As to current activities, in SECY-92-395, " Proposed Change to the General Statement of Policy and Procedure for NRC _

Enforcement Actions, 10 CFR Part 2, Appendix C," the staff has proposed changes to the examples for categorizing misadministrations, in Supplement VI, to focus more on the root cause of misadministrations. This change would place more emphasis on programmatic weaknesses (i.e., deficiencies in such things as procedures, supervision, staffing, or training), rather than the isolated actions of a single individual, without the presence of management or programmatic weaknesses. However, even in the absence of such weaknesses, escalated action would be taken if there were a death or serious injury caused by the misadministration. All cases involving violations of the Quality Management rule, including misadministrations, are being reviewed by the Office of Nuclear Material Safety and Safeguards (NMSS) and the Office of Enforcement, to ensure consistency of approach. If the Commission approves the changes to the Severity levels, these reviews will be especially important in cases involving programmatic weaknesses, to ensure consistency of approach.

The staff is also considering changes to the assessment process. Currently, Table I of the Enforcement Policy designates a base penalty for each type of licensee.

Medical institutions have a base penalty of $5000 and individual doctors or clinics have a base penalty of $1000.

However, it is recognized that, within these classes of licensees, there is a wide range of sizes and abilities to pay. As a result, the amounts of the civil ppnalties do not, in themselves, have much deterrent value with larger licensees. While it is clear that licensees wish to avoid 3 The deterrent value is the focus here because the current sanctions in the vast majority of cases have been effective in gaining lasting corrective action once NRC identifies the violations. The experience in appearing before NRC in an enforcement conference, receiving the civil penalty action, and the attention generated by adverse publicity has resulted in relatively few repeat violations for several years afte an escalated action.

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The Commissioners 13-the negative publicity associated with the civil penalty process as much as the actual dollar amount, more substantial base penalties may, due to the financial burden, provide additional deterrence by encouraging licensees to review their programs, hire consultants, or increase staff to better comply with requirements.

In regard to civil penalties, the staff-has recently solicited the opinion of the. Advisory Committee on Medical-Uses of Isotopes (ACMUI), regarding civil penalties. The ACMUI's consensus was-that the dollar amount-of most civil penalties is relatively small when compared to- the total budgets of .most medical licensees, especially institutional licensees, and thus is not likely_to constitute an effective deterrent. The associated press release was seen as the more effective deterrent, but, according to the ACMUI, concern over the negative publicity associated with the press release may cause licensees not to comply .with the reporting requirements. Some ACMUI members stated that-instituting " probationary" periods,:or putting a facility on notice of the potential loss of its license for major-programmatic problems would be a more effective deterrent.

The staff will consider those views in developing recommendations to revise the assessment process.

There have also been several misadministrations where the Office cf Investigations (01) has investigated the events surrounding the misadministration. Since 1985, there have been twenty 01 investigations related to medical misadministration with 9 cases-substantiated. ~ Synopses of the 01 cases involving misadministrations.are provided in .

Enclosure 7.

Aareement State Proaram: Most Agreement' States-have provisions.for the levying of monetary penalties. Normally, enforcement letters are issued within 30 days after inspections-and use appropriate regulatory language clearly specifying all items on- noncompliance and health _ and-safety-matters identified during the inspection and referencing the appropriate regulation or license condition being violated.

Enforcement letters specify the time period for the_ licensee to respond indicating corrective actions and actions taken to prevent recurrence (normally 20-30 days). Most States have written procedures _ for handling. escalated enforcement cases of varying degrees. While the Agreement States enforcement program is reviewed for adequacy during the biennial reviews, the investigation program is reviewed for status and general programmatic information. Impounding.of material is done in accordance'with State administrative '

procedures and opportunity for hearings are provided to

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ensure impartial admin'.strat ion of the radiation control program. Enclosure 6 includes statistics for enforcement cases and investigations in Agreement States. The Agreement States also conduct investigations of misadministraticos, as they believe are warranted.

4. Aareement State Adeouacy and Compatibility Reviews As part of an agreement whereby NRC relinquishes its regulatory authority for source, byproduct, and-special nuclear material. in less than critical _ quantities,-- and the State assumes that authority,_a commitment is made by the State to use its best efforts to maintain a program that is adequate to protect the public health and safety and compatible with the NRC program. - A description of the -

criteria and process for determination of adequacy and compatibility is provided-in enclosure 8.

On January 1, 1993, 24 of the 29 States were adequate (15 of the 24 States were both adequate and compatible) and in 5 of the 29 States a finding was withheld. .(See attachments to enclosure 8 for statistics on Agreement State Programs).

The Commission has allowed States 3 years for the adoption of new regulations which are required for compatibility, to provide them with the necessary lead time to=make needed changes. When there are problems with the adequacy and/or compatibility of a State's program, OSP staff documents-the finding with a letter to the appropriate State officials and then meets with senior officials in the Executive Branch and, in some cases, with the. Governor of the State, to expedite necessary changes.

B. Followuo of Patients Sub.iect to Misadministrations The series in the Cleveland P_ lain Dealer raises the' question -

of NRC responsibility-to determine not only the circumstances, but the magnitude.of the consequences of

! activities it authorizes, particularly when NRC knows there p has been a series of serious misadministrations inv.'ving-numerous patients. This, in turn,_ raises the issue whether

NRC's current regulatory practice with' regard to patient-followup should be retained or changed. NRC's regulatory program is designed to ensure that the patient _ receives the dose of radiation or the dosage of radioactive material

prescribed by the physician. NRC does not regulate the l- appropriateness or effectiveness of prescribed dose or prescribed treatment.

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The Commissioners 15 Part 35 requires licensees to notify NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of '

the discovery of a therapy misadministration. In addition, NRC requires the licensee to notify the referring physician and the patient of the misadministration-no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring physician personally informs the licensee either- that he will inform

• the patient or that, based on medical judgment, telling the-patient would be harmful.. After NRC receives initial notification from the licensee, a determination is made whether to conduct an inspection. The regulatory practice described below is the current basis for that inspection-effort. As a special note, some Agreement States do followup inspections on serious misadministrations.

However, none have a written policy.

In response to a reported misadministration, the staff may-take several actions. For misadministrations involving very high doses or multiple patients, the staff may ~ form and charter either an Incident Investigation Team or an Augmented Inspection Team .For less significant ~

misadministrations, prompt special inspections may be conducted before the next scheduled inspection. _A determination is also made as- to whether other members- of-the public, such as family members, other patients, and.

healthcare workers, came into contact with the patient or'in some other way were exposed to radiation.- One purpose is to ensure persons potentially exposed in excess of 100 mrem are informed so they can seek appropriate medical evaluation.

The circumstances of every misadministration are to be reviewed during an inspection.

When evaluating misadministrations, NRC staff attempts to:

1) determine the root cause of the_ failure; 2) determine whether cor.rective actions have been taken; 3) take appropriate enforcement action where violations of regulatory requirements contributed to the misadministration; and 4) ascertain whether the referring physician and patient (or responsible relative), as required, are-notified. Whenever members of the general public have been exposed as a result of the special circumstances involved in the misadministration, the staff requires the licensee'to evaluate the exposures and make appropriate notifications. After analysis of the results of the evaluation _ of a misadministration, NRC staff may: 1) share generic findings with NRC and Agreement State-licensees using-similar equipment or procedures and other Federal agencies, as applicable; and 2) propose modification of its own-regulations and procedures, to prevent recurrence, if necessary.

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NRC staff obtains the service of a medical consultant for any serious misadministration (and on a case-by-case basis for other incidents) to: 1) assist in the investigation activities following misadministrations and overexposures;

2) recommend where to obtain. additional medical skills for sppropriate followup; and 3) consult with physscians performing patient medical followup, to obtain information related to the misadministration. NRC does not retain the medical consultant to evaluate the appropriateness of-the prescribed treatment, or its medical offectiveness. NRC has procedures for voluntary participation in the Department of Energy's long-term morbidity study of individuals involved in radiation accidents, including misadministrations.

Before further discussion, the term " patient followup" needs to be clarified. The term can have two meanings: first, evaluating the immediate and short-term consequences, to the patient (s) or others, of receiving a dose other than that prescribed by the physician and second, evaluating the long-term consequences to the patient (s) or others. Each of these meanings can have different ascribed regulatory purposes which are discussed below.

There are a number of regulatory purposes for which it is-necessary to-determine the immediate and-short-term consequences pursuant to NRC's statutory mandate to protect public health and safety. The Commission needs to know-the magnitude of the consequences of errors associated with the activities-it authorizes. The consequences are relevant in determining the appropriate enforcement sanction in the particular case. The significance of the consequences determines the need for an Abnormal Occurrence report pursuant to Section 208 of the Energy Reorganization Act of 1974. Further, the magnitude of the consequences may be a consideration in determining the adequate level of regulatory oversight and allocation of NRC resources. It_

also advances an objective of the misadministration reporting rule; to _ facilitate informed healthcare decisions by patients (or responsible relative) who.need to know the likely consequence of the misadministration in consultation-with their referring physician. The Office of General Counsel (0GC) believes these reasons for immediate and short term followup are persuasive. NMSS believes that current practice. meets these regulatory purposes.

It has been suggested that another and different regulatory purpose for determining the-short-term consequences may be

.that NRC has a humane obligation to assist those who may.

have been injured by providing a program for identifying those patients affected by errors;and notifying their

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'c The Commissioners 17 physicians (e.g., memorandum from Peter L. Strauss to Commission dated August-5,1976 (Enclosure 9)). This purpose would derive from the NRC statutory hiandate to protect public health and safety and the notification aspects were addressed in the 1980 misadministration reporting requirements. Any_ expansion of the possible' role for NRC in assisting the injured patient would require careful definition. For example, assuring the patient and/or referring physician is aware of the misadministration and its consequences-(insofar as they are known) and making the patient's physician aware of available expertise represents the modest effort to assist the patient as is the current practice. On the other hand, at the extreme, one could hypothesize an NRC peer review of existing patient management and recommending subsequent-treatment or support to the patier.t in civil law suits against the licensee. In-these cases, the case-specific nature of each misadministration, and associated variables, could require detailed medical knowledge, possibly. confidential, about the patient, and a spectrum of medical skills, to enable NRC to make appropriate recommendations and initiate remedial action. This extreme position would appear to be-inconsistent with the 1979 medical statement provision about <

minimizing intrusions into the practice of medicine, and could also entail NRC liability to the patient. No one, to our knowledge, has suggested such an-extreme role for NRC.

The issue is when is it appropriate for the NRC to cease its followup activities. After the Riverside incident .the staff concluded that once the root cause for the error was known and after determining that the error did have significant consequences,-such as severe injuries or deaths, no further; investigation into the consequences was necessary on a patient-by-patient basis. Since Riverside, the NRC has changed its regulations and practices to now determine, in the short term: 1) the root cause and whether the error had some signif' cant consequences. 2) the magnitude of the evident consequences, 3) the notification of the referring physicians and patient (as required) and 4) a modest effort to provide some medical consultative assistance to the attending physician. It should be noted that the NRC's current practice is.that following notification to the referring physician and patient (as required), subsequent-follow-up is a physician-patient matter The deviation in the dose given in some misadministrations is of such magnitude that the conclusion of radiation-induced injury or death is evident. In other cases, more time may be required before effects are evident. Further actual determination of cause of death or injury may be difficult or impossible to determine in some instances.

i l-N

• ~ -- - - < - - . < - - , . . - , ,.,,-m-, . --- - . . - . .

~ '

_,.l The Commissioners 18 .

Turning now to long-term consequences and followup of patient (s) or others, a regulatory purpose would be to add to the knowledge about the long term effects of large radiation doses. This regulatory purpose is derived-from the NRC's statutory mandate to protect public health and safety. This knowledge might be used as the basis for j

regulatory changes. In addition, knowledge about organ impairment or death resulting from very serious or multiple j

exposures might serve to focus attention on the seriousness of misadministrations and prompt licentees to take  :

corrective actions more promptly or extensively. There are l several counter arguments to the above stated- regulatory - ,

purpose for long-term followup. More detailed knowledge of  !

long-term consequences is highly unlikely to risult in any j regulatory changes beyond those that may be tir,tified by immediate or short-term consequences. Furthermore, long-term folicw n iy require long-term communication with the.

person exposed or his/her physician through consulting or staff medical piofessionals. There could ba significant resource implications in going beyond current regulatory practice to do long term followup _in this area. This could requ.ir.e expardon of the medical related specialties currently utilized as consultants. In1 addition, an _

extensive recordkeeping system would need to be established.- <

Additionally, varicus scientific organizations currently.

review dt,ta on consequences and risks to individuals exposed to radiation. A staff effort could duplicate their work and only would be applicable to a small . specific population.

Another regulatory purpose for followup on the long-term .

medical consequences of individuals subject to a misadministration is to assist those who may have been injured in obtaining appropriate medical' care. The arguments in favor and opposed to this purposefare essentially the same, as set:out above,.for providing '

assistance to patient (s) with regard to immediate or short term consequences.

C. fxcansion of NRC Reaulatory Purview The Cleveland Elain Dealer articles raised the issue that NRC repeatedly has declined to regulate electrically generated forms of radiation, such as X-rays. There is no 1.tatutory basis for NRC regulation since these devices do not involve byproduct material. The staff is unaware of any formal request for NRC to regulate X-ray or other electric radiation-producing devices for medical uses. There has been no Commission decision on this issue.

e - . _ , - _ - -- - -

i The Commissioners 19 The NRC regulation of the medical use of radioactive material is limited to byproduct material, source material, or special nuclear material. NRC's statutory authority to regulate the domestic medical uses of byproduct material is found in the Atomic Energy Act of 1954, as amended. Section 81 of that Act authorizes NRC "... to issue general or specific licenses to applicants seeking to use byproduct material ... for medical therapy ... or other such useful applications as may be developed."

The issue of expanding the scope of HRC regulation to -

include naturally occurring or accelerator-produced  :

radioactive material (NARM) has been raised on numerous occasions in the past. In May 1988, the Conference of Radiation Control Progran Directors, Inc. (CRCPD) requested NRC to seek legislative authority to regulate and license NARM. Following the recommendations discussed in SECY 64, " Naturally Occurring and Accelerator-Produced Radioactive Materials," NRC referred the issue of Federal regulation of NARM to the Committee on Interagency Radiation Research and Policy Coordination (CIRRPC) for purposes of developing an integrated policy and agency assignments on NARM. The results of the Policy Subpanel on NARM review were forwarded to the Commission as part of the quarterly report of current CIRRPC activities (SECY-92-423). The subpanel did not identify risks caused by discrete NARM, that would warrant expanded Federal authorities. However, a comprehensive review of the Atomic Energy Act and other Federal authorities was suggested as timely to achieve uniformity in radiation protection.- Some members of the subpanel did recommend that the Atomic Energy Act be expanded to include NARM for consistency of controls, although there is not a clearly defined risk.

If NRC were to explore the issue of expanding NRC regulation and oversight of the medical use of all radioactive material and radiatim sources, the extent to which the authority should be o ded would need to be defined'in terms of the sources of u .. zing radiation. This expansion could possibly include: 1) NARM; 2) accelerator-produced radioactive material; 3) cyclotron-produced radioactive material (e.g., radioisotopes used for Positron Emission-Tomography); 4) linear accelerators; 5) orthovoltage X-ray-machines; and/or 6)-diagnostic X-ray machines. All of the above items are under some degree of jurisdiction of other Federal and/or State agencies.

The Commissioners 20 STAFF MEDICAL MANAGEMENT PLAN:

The staff is currently developing a management plan for the reassessment of the medical use program. A key component of the management plan is continuation of the staff initiatives previously identified to senior management and the Commission (memorandum dated September 24 1992, to the Commission from James Taylor), as well as others that have emerged as the result of continuing interaction with the regulated community. In addition to these initiatives, the staff has identified other program areas that should-be reviewed to determine if substantial changes would improve the medical use program. A " Medical Issues" paper was prepared by the staff and discussed with the ACMUI and -

representatives of the Agreement _ States in October 1992, and with NRC regional management in November 1992. The management plan is scheduled to be forwarded to the Commission in the next few months.

RE-EVALVATION INITIATIVES:

o Risk Analysis and Human Factors NRC currently has several contracts in place with national laboratories and private entities to evaluate the risks associated with emarging medical technologies and the human error component of misadministrations. These include: 1) a contract for the investigation of certain therapy misadministrations, to analyze the root cause(s); 2) contracts to evaluate the contribution of the human-machine interface in brachytherapy and teletherapy performance errors; and 3) contracts to-evaluate quality assurance and risk associated with brachytherapy procedures and devices,-

and gamma stereotactic surgery. These efforts could result in revised equipment and operating procedures, and form the basis for revised regulations and revision of inspection -

procedures and frequency. Contract work has yet to be ,

completed.

o Incident Investication Report on Brachytherany Incident An Incident Investigation Team (11T) has reviewed the circumstances surrounding the misadministration and subsequent patient death iavolving a high-dose rate afterloader brachytherapy procedure in Indiana, PA. The report of the IIT is scheduled to be completed January 29, 1993.

i The Commissioners 21 o Medical Use Proaram Audits Two independent audits will be conducted of NRC's medical use pro.q ram, as directed by tha Commission in a Staff Requirements Memorandum dated December 21, 1992, in addition to the staff medical management plan. They will include an internal review, to be conducted by a NRC senior management representative; and an external review of the program, to be conducted by an independent entity. The audit conducted by the NRC senior management representative is expected to commence within the next few months and will focus on whether the existing programs, including oversight of the Agreement State program, are being effectively implemented.

This review will be coordinated with the staff manageinent pl an .

A meeting was held on January 7,1993, between NRC staff and Dr. Kenneth Shine, President, Institute of Medicine, National Academy of Sciences (NAS), to explore the possibility of NAS conducting the external review. The goal of this review is to develop an assessment of the adeodacy and appropriateness of the current framework for medical use of byproduct material. It will include an in-depth review of the basic reguhtory rules, policies, practices, and procedures.

OBSERVATIONS AND FURTHER CONSIDERATIONS:

1. The staff believes that, since the Riverside incident, NRC has significantly improved its program for the regulation and oversight of the medical use of byproduct material for NRC and Agreement State licensees. This program has been continually reevaluated and responsive to evolving technologies and lessons learned from incidents in the medical use program.

2. The staff observes that the reported frequency of -

occurrence of misadministrations is low. The Commission is .oncerned with errors that may lead to misadministrations and, in the QM rule, has focused cn those procedures where the radiological risk from mistakes can be significant. The E]>.in Dealer and others allege that misadministrations are underreported. The staff believes the issue of level of reporting needs to be evaluated especially as the Agreement States adopt the new reporting requirements.

.'l l

1 The Commissioners 22 '!

i

3. The staff believes that continuing re-evaluation is I necessary and has undertaken initiatives to improve the effectiveness and oversight of its licensing, inspection, and enforcement programs. This includes evaluating whether there are adequate' resources currently assigned to these programs.  !

4. The staff believes that the issue of expanded followup of patients subject to misadministrations involves I complex policy issues and requires our ,

reconsideration. To gain an additional perspective, _ l the staff believes this issue should also be referred to the group performing the external review. >

5. The staff observes that NRC, FDA, and the Agreement States have programs _ and procedures to review medical  :

-devices. The staff believes that the adequacy of the review of medical devices should be reconsidered and should include all of the programs. Here, too, the staff believes the issue should be referred to the group performing the external review.

6. In SECY-91-039, " Evaluation of Agreement State Compatibility Issues," the staff provided the Commission with-recommendations for review of the ,

policy on compatibility of Agreement State programs.

As part of that analysis, the staff will review the ,

need to include' Agreement State investigation and ,

enforcement programs.

7. The staff will evaluate the need to reassess the civil penalty process and increased base civil penalties.

8. The General Accounting Office has conducted an audit ~

of the national materials-program and the draft statement of facts has been circulated to Program-Offices.

l

I

-lhe Commissioners 23 CoordinatiED: This paper has been coordinated with the Office of the General Counsel, and that office has no legal objection.

Note: This Commission paper should be made publicly ?.vailable at the Commission briefing scheduled for Friday, January 22, 1993.

J

WW amesM.f$ylor

~xecutive Director for Operations

Enclosures:

1. NRC and Agreement State Licensee Inspection and Misadministration Data:

1989-1991

2. SECY-91-139

3. NRC and Agreement State Misadministration Data by State and License Type for 1991

4. Reports on Incidents identified in the ElDlD DU 10I series

5. Annual Training Budget for Agreement State Personnel

6. Escalated Enforcement Data for 1989-1991

7. Synopses of 01 investigation of Misadministration Cases

8. Statistics on Adequacy and Compatibility of Agreement State Programs

9. Memorandum dated August 5, 1976 from Peter Strauss to the Commission DISTRIBUTION:

Ccnmnissioners OGC OCtJ\

OIG OPA OPP EDO SECY

. - . - . y. y y ,. - ---

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,.t..

Enclosure 1 NRC ant Agreement State License Inspection and Misadministration Data .

1989 - 1991 L

, u.u. #. . re - .

NRC MATERIALS LICEllSEE liiSPECTloti %

MISADMINISTRATION DATA: 1989-91 Inspection

1. Lic. Misadministration 1989 freq. # D T' (years)

Medical Broad 114 2/l* 73 84 3 Community llospitals 1438 3 511 327 3 Pvt. Drattice/ Clinics 453 5/4* 137 11 0 Teletherapy 247 3/1" 138 0 4 Total Medical Lic. 2252 Varies 859 422 10 m., _ __

Other Materials Lic. 5347 Varies 1725 0 0 TOTAL 7599 2584 422 10 Other NMSS Licenses NA 205 m n=======2-~ == - == ==w:- ---

-=

Inspection

1. Lic. Misadministration 1990 freq. # D T (years)

Medical Broad 118 1 110 85 6 Community llospitals 1429 3 523 338 9 Pvt. Practice / Clinics 476 4 119 17 0 Teletherapy 237 1 182 0 9 Total Medical Lic. 2260 Varies 934 440 24

__ _ _ . _ _ _ _ _ _ _ . _ _ . _ _ _ - . . _ _ _ . m Varies I Other Materials Lic. 5452 1592 0 0 L _ _ __ __ _ ._ _- _ _ _ _] _ _ _ _ _

i TOTAL 7712 2527 440 24

{ Other NMSS Licenses 502 177

' The number of therapeutic misadministrations for 1989 and 1990 diffor from SECY-91-139 (table 2) because 1-131 that was prescribed in the diagnostic rar.ge but administered in the therapeutic range was included under diagnostic misadministrations in this enclosure.

i l

Inspection ,

1991 # Lic. Misadministration -

1 Freq. # D T (years) l Medical Broad 119 1 105 79 12 b

Community Hospitals 1389 3/2 675 350 5 Pvt. Practice / Clinics 464 4 153 12 0 l Teletherapy 214 1 185 0 2 Total Medical Lic. 2186 Varies -1118 441 19 Other Materials Lic. 5462 Varies 2298 0 0 TOTAL 7648 3416 441 19 Other NMSS Licenses 478 197 a- fl 2800/16 became effective Jan. 1989. It increased inspection frequencies in several categories of medical licensees.

b- TI 2800/71 became effective Feb. 1991. It inereased inspection f requency for comunity hospitats.

l

, -.,m - -- .w - ,.6 -. , . - . . .

i i .

Enclosure 1 AGREEMENT STATE INSPECTION PROGRAM Totals for Review Cycle 1989 through 1991 Major License Category Number of Number of Number of Licenses 2 Inspections overdue Completed 1 Inspections Broad Medical 80 92 4 Community Hospital 2866 1368 67 Private Practice / 742 378 4 Clinic Teletherapy 235 166 9 Total Medical Licenses 3923 2004 81 All other Materials 9647 4644 211 Licenses TOTALS 14555 8513 304 1 Entries do not sum to the column totals as several Agreement States do not record data by license category. For these states, only the totals are included.

2 Inspections must be conducted by the Agreement States at least as frequently as would be conducted by the NRC for the same category of licensee.

I

1 Enclosure 2 SECY-91-139 Response to Staff Requirements Memorandum Regarding An Analysis of Misadministrations and Reporting Thresholds

f_ %, .

wonwcu nouma ce t 2 -==+

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\, * * * * * / CC: i. $lG POLICY ISSUE h  ;%

(Information) 89 May 15, 1991 CSECY-91-139 For: The Comissioners From: James M. Taylor Executive Director for Operations

Subject:

RESPONSE TO STAFF REQUIREMENTS MEMORANDUM REGARDIllG AN AllALYSIS OF MISACP.It:lSTRAT10fl5 AllD REPORTIllG THRESH 0LDS Furpose: In the staff requircrents merorandum (SRM) following the Annual Brir'ir.g ch the f:edical bse Progt tr, the :taff was requested to submit an analysis of trends in, and causes of, misadministrations and to respond to questions on abnormal occurrences and reporting thresholds.

Backcround: The Nuclear Regulatory Comission (NRC) staff briefed the Comission on the medical use of byproduct material on February 12, 1991.

In the SRil, dated fiarch 6,1991, resulting from this briefing, the Comission requested that the staff submit an analysis of trends in, and causes of, medical misadministrations, and provide responses to several questions raised during the briefing. This paper includes the staff analysis of misadministrations and responds to the questions on abnormal occurrences (A0s) and reporting thresholds. The Office of Nuclear Regulatory Research Comission paper transmitting the medical quality assurance (QA) rulemaking will address the f:RC's support of the National Council of

, Radiation Protection and Measurer.ents' ef' orts on assessirg I

CONTACT: NOTE: TO BE MADE PUBLICLY AVAILABLE Janet R. Schlueter, NMSS IN 10 WORKING DAYS FROM THE 492-0633 DATE OF THIS PAPER

The Commissioners 2 ,

the health significance of medical misadministrations. The remaining issues in the SRM, tracking data on enforcement actions and the human factors study by Syncor International, will be addressed in a separate Commission paper scheduled for submission in July 1991.

The enclosure contains the staff's analysis on misadministrations including two tables of data.

Discussion: Analysis of Misadministrations The diagnostic use of radiepharmaceuticals involves the administration of a variety of pharmaceuticals of varying chemical composition, radioisotopes and dose ranges, depending er uhich organ or organ system is to be imaged.

Diagnostic misa ministrations have been reported in a variety of clinical procedures, primarily those using technetium-99m and iodine-131 excretion, uptake, imaging and localization agents. Therapy misadministrations include -

misadministrations as a result of teletherapy, brachytherapy (manual and remote afterloading), and radiopharmaceutical therapy procedures. Radiopharmaceutical therapy procedures typically include the use of iodine-131 or phosphorus-37 in-millicurie quantities. For the purpose of this analysis, therapy misadministration data also include-those procedures where the misadministration involves the administration of therapy-equivalent doses where diagnortic doses wore intended.

The staff analysis of misadministrations (er. closed) is primarily based on data reported to NRC by its licensees for the calendar years 1987 through 1950.. Complete data for 1990 are not yet available, and an estimate of total reports was based on repcrts received for 11 rentfis. Ti.is nisadministration rep'orting requirement was made an item of cccpatability for Agreement States effective April 1,1990.

- The Office for Analysis and Evaluation of Operational Data

.is working with State Programs to develop a uniform reporting system for Agreement States.

An analysis of the trends in misadministrations reported to flRC over the last four years indicates that there has not been a sicrlficant change in the number or type of misadministrations for diagnostic procedures from year to year. Conversely, an increase in the number of therapy misadministrations was observed. This increase could be

3 The Cor:raissioners attributed to several factors, including: (1)anincrease in the number of new and corplex brachytherapy procedures performed including remote afterloading procedures; (2) increased licensee awareness of NRC reporting criteria, the importance of timely reporting, and (3) escalated enforcement actions against licensees for failure to report.

These factors are offered as possible explanations for the increase in therapy misadministrations for 1990. However, it is important to exercise caution when drawing conclusions from a limited data base regarding the increase, which may be a statistical fluctuation.

Heightened licensee awareness results from NRC staff conduct of numerous licensee workshops and meetings with professional societies, such as the Society of Nuclear Fedicine, American College of Nuclear Physicians, American College of Radiology, and American Association-of Physicists in Hedicine, as part of the QA rulemaking. In addition, the NMSS Newsletter and professional society publications describe NRC requirements, inspection results, events that have resulted in misadministrations, and enforcement actions.

The primary types of diagnostic and radiopharmaceutical therapy misadministrations involve administration of the wrong pharmaceutical, wrong amount, or administration to the wrong patient. These misadministrations resulted from miscommunication anongst the licensee staff, errors in the preparation and administration of radiopharmaceuticals, inattention tc detail, inadequate training in specific licensee procedures, failure to follow procedures, lack of, or inadequate procedures, and inadequate supervision.

Brachytherapy and teletheyapy misadministrations were . _

primarily caused by errors and oversights in the treatment

- planning process, patient identification and set-up, failure to follow procedures, lack of, or inadequate procedures, and inadequate supervision. Since the underlying causes of diagnostic and therapy misadministrations appear to be hur.an errors, the focus of regulatory review or action should be, to the greatest extent possible, focused on human factors.-

Relevant portions of this analysis will be inccrperated into the QA rulemaking package.

That Connissior,ers 4

• l A0s and Reporting Thresholds From 1988-1990, there were 38 medical A0s that involved diagnostic and therapy misadministrations.. The current guidance to the staff for _ identifying medical l misadministration events as A0s is based on the amount of l radiopharmaceutical or radiation dose to du crcan or to the i whole body. The criterier. is the ratio of administered to prescribed radiopharmaceutical or radiation dose, One of the cuestions raised during the annual medical briefing anc in the SRH was whether a threshold dose level, such as the thyroid dose associated with 30 microcuries of l iodine-131, would have resulted in any of the 38 A0s falling below the reporting threshold. l 4

Thirty microcuries corresponds to a thyroid dose of approximately 50 rem (ICRP Publication 53, " Radiation Doses toPatientsfromRadiopharmaceuticals"). If both the 30 microcurie and 50 rem organ-dose trigger levels were appifed to the 38 misadministrations designated as A0s between 1988 and 1990, 33 of the-events would continue to be classified as A0s. The breakdown is as follows:

(1) the four diagnostic events not involving fodine would have been eliminated (with a 50 rem organ-dose threshold);

(2) 8 of the 9 diagnostic events involving iodine would continue to be classified as A0s because of the 30 microcurie and 50 rem organ criteria. The ninth diagnostic event would not be' classified as an AO.

Although it exceeded the 30 microcurie threshold, it resulted in less than a 50 rem thyroid dose because the patient's hypothyroid condition resulted in significantly decreased uptake; and (3) the 25 therapy misadministrations designated as A0s would have been reported as such.

The SRM also questioned how a threshold dose level would compare to A0 reporting criteria for non-medical radiation exposures, and if the health consequences from inadvertant' doses were reported in a like manner for medical and non-medical events.

5 The Comissioners The current A0 selection criteria for non-medical overexposure events specify values .that are 5 times the annual'11mits given in 10 CFR Part_20, (i.e., 25 rem whole body; 150 rem skin; and 375 rem to feet, ankles, hands, or forearms; or equivalent exposures from internal sources).

The recently revised 10 CFR Part 20 employs a more modern method of dose calculation which involves the use of tissue weighting factors and effective whole body dose equivalent.

This method attributes specific weighting factors to organs or tissues, representing the fraction of_the total stochastic risk resulting from irradiation cf that organ or tissue when-the whole body is uniformly irradiated. However, dose to organs which night be below a-reporting thresheid using tissue weighting factors for assessment of stochastic risk could be of-such magnitude that deterministic effects (non-stochastic) might be initiated. For this reason, the revised 10 CFP Part PO uses a capping dose of 50 rem for organs (other-than the lens of the eyes) to prevent deterministic effects. .

If 5 times the linits contained in the new 10 CFR Part P0 are used as the A0 criteria, the A0 reporting requirements would be:

- 25 rem effective dose equivalent;

- 250 rem for the sum of the deep-dose equivalent.and the committed dose equivalent to any individual organ or tissue, other than the icns of the eye, e.g., thyroid;

- 75 rem eye dose equivalent; and

- 250 rem shallow dose-equivalent tc the skin or to each of the extremities.

If a 50 rem threshold radiation dose (e.g., 30 microcuries I-131 thyroid dose) were adopted as a reportable AG, it would be equal to the revised 10 CFR Part 20 limits for the comitted effective dose equivalent for organs (as cited cr.

previous page). This threshold is greater than the current 25 rem whole body criterion becruse for non-medical events, the organ do5e criterion is assumed to be the samt as the whole body.

A comparison can be made for A0s involving. teletherapy misadministrations and A0s invelving exposures of radiographers'to external radiation. A0 89-11 involved the exposure cf a radiographer to 93.4 rem localized to his right hip; A0 89-03 involved the exposure of an individual's left

l ..

The Comissioners 6- ,

femur to 250 rem from a teletherapy machine; and_A0 90 -

involved the exposure of_ a radiographer's assistant to' 5000 4 to-7000 rem, localized to the-skin'of the neck. These A0s l discuss in e similar manner health effects'such as erythema-and damage to skin tissue,. increased fatigue and possible bone narrow suppression, or lack of observable effects.

In sumary, over B6% o_f the medical misadministrations-designated as A0s between 1988 and 1990' exceeded e 50 rem-organ dose. 'For_ procedures involving the use of iodine-131, this equates-to a 30 microcurie reporting threshold resulting-in a 1.5 rem effective dose equivalent. This threshold is .;-

more conservative :than the current 25 rem whole body criterion for non-medical events; however, the health effects from-individual doses are reported-in a like manner for medical--- l 4

and non-medical events.

Coordination: The-Office of the General Counsel has reviewed;this paper and has no legal objection. .

~

_ /

LM J mes M. T lor >

xecutive Director for. Operations

Enclosure:

j '

• Staff Analysis of Misadministrations DISTRIBUTION:

-Comn.issioners OCC OIG-GPA EDO l

SECY

STAFF ANALYSIS OF MISADMINISTRATIONS INTRODUCTION The staff analyzed diagnostic and therapeutic misadministration data for the calendar years 1987 through 1990. Of the 2300 Nuclear Regulatory Commission (NRC) licensees authorized to perform diagnostic and therapy procedures, an annual average of 339 (or 15 percent) reported misadministrations. The number of patients involved in these misadministrations annually averaged 472 (some reports involved more than one patient). NRC received an average of 405 diag-nostic misadministration reports annually during these 4 years, ranging from 393 to 415. Complete data for 1990 are not yet available, and an estimate of total reports was based on reports received for 11 months. However', this esti-mate is consistent with previous years, and it is expected that the numoer of licensees reporting and the number of patients involved will not fall outside of the expected range. See Enclosure 1, Table 1 for reporting data.

For the purpose of this analysis, therapy misadministration data also include those procedures where the misadministration involves the administration of For example, 2 therapy-equivalent doses where diagnostic doses were intended.

of the 9 reported for 1990 were the result of the misadministration of diagnostic dosages of iodine-131. An analysis of therapy misadministration reports submitted by NRC licensees during these 4 years, revealed a total of 66 therapy misadmini-strations, ranging from 12 to 27 anually, with the following breakdown: 25 tele-therapy, 21 brachytherapy, 20 radiopharmaceutical therapy procedures (16 involving iodine-131). See Enclosure 1, Table 2 for a breakdown of the types of misadmini-stations reported.

STAFF ANALYSIS OF CAUSES Ofannostic The two primary types of diagnostic misadministrations appear to be the administration of the wrong radiopharmaceutical and the administration of a radiopharmaceutical to the wrong patient (for 95 percent of diagnostic reports).

The root causes reported by licensees continue to be errors associated with the preparation and administration of radiopharmaceuticals, inadequate training in specific licensee procedures, inattention to detail, failure to follow pro-cedures, lack of, or inadequate procedures, and inadequate supervision. Errors include: improper labeling of syringes, shields, and vials; not verifying the radiopharmaceutical label or radioactivity prior to injection; misunderstanding a physician's order; f aulty processing of nuclear medicine requests; and inade-quate verification of patient identity.

Radiopharmaceutical Therapy A review of radiopharmaceutical therapy misadministration reports revealed that many of the errors resulted from failure of the authorized user to review the f

Enclosure 1

2- .

medical history of the referred patient, to determine the suitabilit/ of a particular clinical procedure, miscommunication amongst the licensee staff, or misinterpretation of the physician's orders. This brought about two common errors: the wrong radiopharmaceutical and the wrong dosage.

Therapy There are various causes of therapy misadministrations due to the complexity of the brachytherapy and teletherapy treatment planning process. Misadmini-strations in therapy primarily involve administered doses differing from the pre-scribed dose by more than 10 percent, or a dose to the wrong part of the body.

The causes include: staff miscommunication regarding the area for treatment; errors during simulation; selection of the wrong sealed source; selection of the wrong source activity; wrong information entered into the treatment plan-ning computer; misinterpretation of a computer error message before treatment commenced; misinterpretation of the prescription; arithmetic errors in dose calculations; use of the wrong data in dose calculations; misreading treatment time; and f ailure to positively identify the correct patient.

In general, most misadministrations of any type can be attributed to: failure to follow procedures, or lack of, or inadequate procedures; inattention to detail; inadequate training in specific licensee procedures, and inadequate supervision.

CORRECTIVE ACTIONS PROPOSED BY LICENSEES For diagnostic misadministrations, approximately 50 percent of the corrective actions proposed by licensees include the retraining of personnel in specific procedures. Other corrective actions include the development and implementa-tion of new procedures aimed at detecting and reducing errors, such as, label--

ing and identifying radiopharmaceuticals stored in lead shields or untagged reagent kits; identifying sealed sources and the activity of each; processing of physician referral requests; and patient identification. Two less frequently cited corrective actions are the reprimand of personnel and increased or improved supervision. The technologist preparing or administering the radiopharmaceutical appears to be the person primarily involved in most misadministrations involving diagnostic dosages.

The most frequently cited corrective actions for teletherapy misadministrations include: retraining of personnel in specific procedures; redundant patient identification; verification / double checks of dose calculations and patient set-ups; and routine chart checks. The technologist, dosimetrist, physicist, or -

I authorized user might be primarily responsible for therapy misadministrations, depending on the treatment? , odality, or in what stage of the treatment plan the error occurs.

l t

i.

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4 TABLE 1 MEDICAL MISADMINISTRATIONS REPORTED TO NRC FROM 1987 THROUGH 1990 +

t 1987 1988 1989 1990* Total- g-

'405 417 442 1687- 422~

No. of Reports 423' 470- '486 ' ---~ 1415 472 No. of Patients 459 344 326 --- 1018 339 No. of Licensees- 348 Reporting ..>

t

*-Data are incomplets for 1990; the number of. reports is an estimate for the entire year based on 11 months of! data. .

The reports have not'yet been reviewed in tufficient detail to. report number of patient; and number _ of licensees reporting. .

M S

I r

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t s

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n. y y q ?+ W a a h w TABLE 2 KE01 CAL HISADMINISTRATIONS CATEGORIZED BY TYPE FROM 1987 THROUGH 1990 1987 1988 1989 1990* Total Avg 14 12 13 27 66 17 Therapy 6 5 4 10 25 6

a. Teletherapy 3 5 5 8 21 5

b. Brachytherapy 4 9 20 5

c. Radiopharmaceutical 5 2 Therapy **

409 393- 404 415 1621 405 Diagnostic

• Data are incomplete for 1990 and are based on 11 months of reports.

• • Includes misadministrations of prescribed diagnostic dosages that resulted in <

unintended therapy-equivalent doses.

W G

.g .:

4 t

Enclosure 3 i

NRC and Agreement State Misadministration Data by State and License Type for 1991 k

'l.

y 6

1991 MISADMINISTRATIONS BY STATE AND LICENSE CATEGORY

'I. AGREEMENT STATES STATE Broad Medical Community Hosp. Private Teletherapy Practice / Clinic ll#Lic. Diag. Ther. # Lic. Diag. Ther. # Lic. Diag. Ther.  :# Lic. Ther.

0 0 82 7 1 28 2 0 6 0 Al abama 2 0 0 58 12 0 11 0 0 5 0 Arkansas } 1 0 34 16 43 1 0 2 0 Arizona 2 1 1 0 0 25 0 California 8 6 1 677 50 3 7 0 50 12 14 0 0 0 0 Colorado 1 0 1 Florida 3 7 1 207 59 0 256 11 0 35 0 118 0 0 55 0 0 16 0 Georgia 0 0 0 0 40 6 0 7 0 0 2 0 lowa 1 1 6 0 154 19 0 30 0 0 23 0 Illinois 14 0 69 0 0  ?, 0 0 0 0 Kansas 1 0 66 8 0 0 10 0 Kentucky 3 1 0 _ 20 1 90 0 0 80 0 0 0 0 Louisiana 1 0 0 Maryland 3 6 0 43 14 0 64 1 0 15 1 0 0 0 26 0 0 1 0 0 1 0 Maine 0 0 7 0 Mississippi 1 0 1 76 0 0 ,

6 8 0 2 0 6 2 North Carolina 5 7 1 98 _ 21 0 0 0 0 0 0 0 North Dakota 1 0 0 16 0 30 5 0 13 0 0 3 0 Nebraska 1 1 New Hampshire 0 0 0 27 5 0 1 0 0 2 0 0 21 2 0 18 0 0 1 0 New Mexico 1 3 0 0 11 1 15 1 0 1 0 Nevada 0 1 0 I 236 25 0 379 0 0 66 2 New York 12 1 0 40 12 0  ; 11 0 0 1 0 Oregon 1 4 10 0 10 0 0 0 0 Rhode Island 2 4 0 3 0 9 0 0 4 0 South Carolina 1 0 1 52 1 0 0 128 9 0 30 0 0 11 0 Tennessee 1 8 0 358 34 0 116 4 0 21 0 Texas 16 0 0 20 6 0 3 0 0 0 0 Utah 2 0 0 45 2 0 17 1 0 1 0 Washington 2 TOTAL 86 55 6 !2,882 316 7 1,292 31 0 264 5 l

1991 MISADMINISTRATIONS BY STATE AND LICENSE CATEGORY .

'II. NRC STATES AND FEDERAL FACILITIES IN AGREEMENT STATES STATE Broad Medical Community Hosp. Privace Teletherapy Practice / Clinic

1. Lic. Diag. Ther. # Lic. Diag.fTher. l# L k. ! Diag. lher. # Lic. Ther.

Alabama 1 0 0 1 0 0 0 0 0 0 0 Alaska 0 0 0 6 0 0 1 0 0 0 0 Arizona 0 0 0 3 0 0 0 0 0 0 0 Arkansas , 1 0 0 0 0 0 0 0 0 0 0 C lifornia l 6 4 0 5 6 0 0 0 0 1 0 Colorado 2 0 0 1 0 0 0 0 0 1 0 Connecticut 3 0 1 37 10 0 29 3 0 5 0 Delaware 0 0 0 9 1 0 6 0 0 1 0 District of 6 6 1 8 4 0 8 1 0 5 0 Columbia Florida, 2 0 0 3 0 0 0 0 0 0 0 Georgia 2 0 0 4 1 0 0 0 0 0 0 Guam 0 0 0 1 0 0 0 0 0 0 0 Hawaii 1 0 1 14 3 0 4 0 0 0 0 Idaho 0 0 0 20 1 0 0 0 0 0 0 Illinof; 2 2 0 2 1 0 0 0 0 1 0 Indiana 3 4 0 88 23 0 16 0 0 17 0 lowa 1 1 0 1 0 0 0 0 0 0 0 Kansas 0 0 0 0 2 0 _0 0 0 0 0 Kentucky 2 1 0 1 0 0 0 0 0 0 0 Louisiana 1 0 0 2 0 0 0 0 0 0 0 Maine 0 0 0 26 9 0 2 0 0_ 1 0 Maryland 1 2 0 4 0 0 1 0 0 0 0 Massachusetts 13 6 0 80 7 0 11 0 0 8 0 Michigan 7 8 0 136 36 0 81 4 0 13 0 Minnesota 4 1 0 45 7 1 2 0 0 7 0 Mississippi 0 0 0 2 0 0 1 0 0 0 0 Missouri 5 12 ,0 89 14 0 10 0 0 18 1 Montana 0 0 0 19 5 0 3 0 0 0 0

Nebraska 1 0 0 1 0 0 0 0 0 0 0 Nevada 1 0 0 0 0 0 0 0 0 0 0 New Hampshire 0 0 0 1 0 0 0 0 0 0 0 New Jersey 3 0 0 95 34 2 59 0 0 15 0 0 0 0 0 0 0 0 0 0 0 New Mexico 1

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11. NRC STATES AND FEDERAL FACILITIES IN AGREEMENT STATES (cont'd)  !

STATE Broad Medical Community Hosp. . Private Teletherapy Practice / Clinic

1. Lic. Diag. Ther. # Lic. Diag. Ther. f_Lic. Diag. Ther. # Lic. Ther.

New York 3 0 0 6 '2 0 0 0 0- 3 0 North Carolina 1 0 0 4 0 0 0 0 0 0 0 North Dakota 0 0 0 1 0 0 0 0 0 0 0 Ohio 9 10 2 160 51 2 40 0 0 27 0 Oklahoma 4 1 0 55 9 0 8 0 0 11 0 Oregon 0 0 0 2 0 0 , 0 0 0 0 0 Pennsylvania 12 9 3 191 68 0 69 0 0 15 1 Puerto Rico 1 0 0 22 2 0 15 0 0 5 0 Rhode Island 1 0 0 0 0 0 0 0 0 0 0 South Carclina 0 0 0 3 0 0 0 0 0 0 0 South Dakota 0 0 0 14 2 0 1 1 0 0 0 Tennessee 1 0 0 3 3 0 0 0 0 0 0

. Texas 4 4 2 6 1 0 1 0 0 2 0 Utah 1 0 0 0 0 0 0 0 0 0 0 Virginia 3 0 0 81 18 0 26 0 0 10 0 Virgin Islands 0 0 0 1 0 0 0 0 0 0 0 Vermont 0 0 0 4 0 0 0 0 1 0

_ 14 Washington 1 1 0 3 2 0 0 0 0 1 0

. West Virginia 1 0 1 40 9 0 10- 0 0 4 0 Wisconsin 5 8 1 1 64 16 0 9 0 0 4 0 Wyominq 0 0 0 15 1 0 0 0 0 0 0 TOTAL 116 80 12 1389 352 5 413 9 0 176' 2

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- Enclosure 4 -

Reports on Incidents Id'entified in the-Plais Dealer Series'  ;

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.4 CLEVELAND CLINIC. CLEVELAND. OHIO

1. OF PATIENTS: One PATIENT: Philomeena McNeeley SYNOPSIS OF PLAIN DEALER ARTICLE: ,

The Plain Dealer reported that, ducing cobalt-60 teletherapy treatment for a rare blood and bone marrow disorder, Ms. McNeeley received a seventy percent overdose due to a mistake by the. physicist, in which the incorrect distance-from the source to the patient was used in the dosimetry calculations. As~ a result of the overdose, Ms. McNeeley received burns to over fifty-five percent of her body and was admitted to Cleveland Metropolitan General Hospital burn unit on November 11, 1986, for treatment. She died on November 18, 1986 with burns over 90% of her body.

INFORMATION KNOWN BY NRC PRIOR TO PUBllCATION:

On October 6-8, 1986, a 58-year-old female patient,. receiving teletherapy treatments for bone marrow disease, received a total dose of 2,000 rad instead of the prescribed dose of 1,200 rad, a 67% overexposure. The misadministration was due to an error in calculating treatment time. The physicist who performed the calculations used the distance from the cobalt-60 radiation source to the patient, instead of the distance from the exterior of the radiation therapy device to the patient.

The patient was discharged on October 10, was readmitted on October 20 for symptoms believed to result from the radiation exposure, discharged, and readmitted on November 10 to another facility with skin burns. The patient died on November 18, 1986. The licensee did not detect the error until November 11 when a patient chart check was performed, and the event was not reported to NRC until November 17.

A panel of NRC medical consultants, consisting of two physicians and a-physicist, reviewed the case and concluded that the radiation treatments had

" minimal effect, if any, upon the fatal outcome of her disease." The panel of-consultants indicated that the skin burns were not attributable to the radiation treatment, but to a variety'of drugs given to the patient prior to-and in addition to her radiation therapy.

The licensee had an existing policy which required dual verification of all dose calculations prior to the first day of treatment; however, it was not-followed in this case. As a result of this misadministration, the original ,

policy was revised to include: 1) all dose calculations will be independently performed, and that 2) prior to each treatment, this will be verified; 3) treatment data will be reviewed weekly by the chief technologist; and 4) quarterly audits by the Radiation Safety Committee would be performed for a year and then annually thereafter.

NEW INFORMATION FROM PLAIN DEALER:

None INFORMATION GATHERED SINCE PUBLICATION:

None PATIENT F0ll0W-UP:

Follow-up by was done by a panel of NRC medical consultants. The patient's 1

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relatives and the ' referring physician were. notified.

HRC_ ENFORCEMENT ACTION:

NRC promptly issued _ a Confirmatory Action Letter-documenting _the revised policy as described above. NRC identified two violations were identified for which a civil penalty of $2500-was imposed.

LICENSEE HISTORY:

. The teletherapy license was originally issued in June 1956, and terminated December 17, 1990.

. Other therapeutic misadministrations

1) On February 15, 1990, NRC was notified that on February 8, 1990 a patient received a teletherapy dose 50% greater than prescribed.

Initially, the physician prescribed a total of 9 treatments of 278 rom each to the cervical spine area. Following the first two treatments, the physician decided to stop treatment completely-and wrote "stop treataent" on the first page of the treatment chart.-

Not seeing the note on the first page, the technologist turned to the second page to check the treatment parameters and administered a third treatment of 278 rem. The staff became aware of the stop treatment order later that same day. .

The cause appeared to be the lack of a clear mechanism for documenting any changes in prescriptions prior to subsequent treatment. The licensee's corrective actions included enhanced quality assurance procedures and retraining of staff.

NRC conducted a special inspection and an Enforcement Conference was held with the licensee. A civil penalty of $6875 was proposed and paid by the licensee. .The. referring physician was notified, but not the patient or the relatives because "it was determined by-the referring physician that this was a misadministration in the technical sense and not -in the medical sense. relative to patient care".

2) On January 17, 1992, the licensee reported that a patient received a radiation dose 57% greater than prescribed in a therapeutic treatment. The patient was prescribed 2676 rad in a brachytherapy gynecological procedure using 5 Cesium-137 sealed sources loaded in a Fletcher-Suit applicator; however, 2 of the. 5 sources implanted had an activity greater than intended and yielded a treatment area radiation dose of 4205 rad.

The error was discovered by the licensee shortly after the brachytherapy sources were explanted on January 17, 1992. The referring physician of the patient was notified, a second similar treatment planned for the patient may be altered, based on clinical effects from the first treatment.

A special inspection was conducted January 28-29, 1992 and found no violations of NRC regulatory requirements. A medical consultant reviewed the event.

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3) 'On April 24, 1991, the licensee reported a therapeutic _

misadministration. The patient received a brachytherapy treatment dose 32% lower than the dosage prescribed. The misadministration occurred because the dose-calculations were based on a-tumor distance of 1.0 cm, instead of the prescribed distance of 1.5 cm.

Consequently the licensee ordered Ir-192 sources of a lower strength than that required. The error was identified- by the licensee on April 23, 1991, during a post treatment review. The referring physician and the patient have been' notified, and'no further-treatment is planned. RIII reviewed the event during an inspection >

conducted between May 18, 1991, and June 18, 1991. No violations were identified with respect to the misadministration.

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DJ110 VALLEY HOSPITAL. STEUBENVILLE. OHIO

1. OF PATIENTS: One i PATIEN1: Jean Matalik SYNOPSIS 0F PLAIN DEALER ARTICLE:

The Plain Dealer reported-that Ms. Matalik had a hole burned in her chest' during five weeks of cobalt-60 treatment for breast cancer ending in March 1988. As a result of her injuries,-she developed depression and. committed suicide in August 1989. It further reports that the doctor claims that he advised her to go to another hospital in Pittsburgh to be- treated with a linear acceleratcr, because it would be safer . She refused to go because of the long drive, so he treated her with the Cobalt-60 unit which required a larger dose.

INFORMATION KNOWN BY NRC PRIOR TO PUBLICATION:

On September 14 and 15, 1992, an NRC inspector performed an unannounced safety inspection of Ohio Valley' Hospital prompted by concerns raised by one of the Plain Dealer reporters regarding a possible teletherapy misadministration, in which a patient received cobalt-60 radiation beginning on February 11, 1988, totaling a dose of 7500 rads, instead of the~ prescribed total dose of 5000 rads.

The inspector examined the patient's treatment chart to review the .

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prescription, treatment plan and treatment records. The review determined that the patient was prescribed and received 5000 rads to the tumor volume at a depth of 5 centimeters; therefore, a misadministration had not occurred.

The maximum dose to tissue was at the skin and was approximately_7500 rads.

Transcripts of depositiens for the malpractice case involving this patient's treatment reviewed by the inspector did not_ indicate that the patient received a dose of radiation that differed from what the physician prescribed.

However, the patient exhibited significant radiation effects. The physician' ,

apparently was aware of and considered the risk of such damage-when he approved the treatment plan prior to initiation of treatment.

NEW INFORMATION FROM PLAIN DEALER:

None INFORMATION GATHERED SINCE PUBLICATION:

None PATIENT FOLLOW-UP:

None, since a misadniinistration did not occur.

NRC ENFORCEMENT ACTION (IF ANY):

None, since a misadministration did not occur.

LICENSEE HISTORY:

- The license was terminated September 20, 1991.

. There were no reported therapeutic misadministrations.

• Tissue damage frequently occurs as part of radiation treatment, due to the-fact that the tissue-overlaying the tumor will receive a higher dose than the deeper tumor volume. For lower energy photons the maximum radiation dose is 4

delivered just at or below the skin. As the energy of-the photons is increased,-as with c linear accelerator,-the difference between'the maximum dose further below the skin and the tumor dose-is~ decreased. The use of a linear accelerator with its higher. energy photons can. deliver a specified dose to a' tumor with-less damage to surrounding tissue, that is the case for cobalt-60 in some instances. 1

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i QVERLOOK HOSPITAL. SUMMIT. NEW JERSEY

1. Of PATIENTS,: One PAllENT: Connie Norris SYNOPSJ,5._QF_ PLAIN DEALER ARTICLE:

The Plain Dealer reported that during treatment for Hodgkin's disease with a-Linear Accelerator in 1984, Ms. Norris's spinal cord was overexposed because the doctor failed to shield her spinal cord. As a result, by June 1985, Ms.

Norris was paralyzed from the neck down and now lives in a nursing home.

INFORMATION KNOWN BY NRC PRIOR TO PUBLICATION:

None NEW INFORMATION FROM PLAIN D ELB:

All of the information in the Plain Dealer.

INFORMATION GATHERED SINCE PUBLICATION:

NRC Region 1, contacted the Radiation Jafety Officer (RS0), and was informed that in 1984-85 a 30 yr old female was treated with a Linac for Hodgkin's disease. According to the RSO, she received the prescribed dose of 4000 rads to the mediastinum and 4200 rads to the cervical region. Within 2 months she -

developed paralysis and sued the hospital. An expert witness for the hospital testified that the abrupt onset of the patient's paralysis indicated that the paralysis was not caused by radiation induced transverse myelitis. Testing undergone by the patient suggested the patient might have multiple sclerosis, but additional testing was refused by the patient so that confirmation was not obtained (according to the RS0). The patient won the case. She is still living and is still paralyzed.

PATIENT FOLLOW-UP:

None, not within NRC regulatory purview.

NRC ENFORCEMENT ACT103:

None, not within NRC regulatory purview, -

LICENSEE HISTORY:

The licensee has been licensed since 1956.

• The licensee is inspected every three years.

• Escalated Enforcement Actions EA 91-163, $3125 Civil Penalty issued for October 1991, 1-131 misadministration. Patient was administered 2 mci 1-131 instead of 300 uti 1-123.

- Other Therapeutic Misadministrations

1) On November 1, 1991, the NRC headq'1arters duty officer informed the NRC Region 1 office that the misadministration occurred at the Overlook Hospital in Summit, NJ. A 27 year old fcmale patient was to have undergone a thyroid uptake study and scan involving the administration of 300 uti of I-123. Although the responsible physician intended to perform a thyroid uptake study using 300 uti of I-123, he erroneously requested that the patient be administered 2 mci of 1-131 for a whole body scan. Tne nuclear medicine technologist, responsible for administering the dose to the patient, 6

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V questioned _the physician as to the exact study requested. The physician confirmed that a whole body scan using 2 mci of _l-131 was-requested. _The dose was administered on October 30, 1991. On November 1, 1991, the. physician, upon reviewing the results of the study, discovered that he intended to perform an uptake study _using 300 uti of I-123. The appearance of an imaged thyroid-triggered the realization that a wrong study had been performed. -The patient, when asked by the licensee prior to administering the dose, stated that she was not pregnant and was not nursing. NRC Region.1 i contacted an NRC medical consultant on November 1, 1991 to review the 1)- the quantification of the dose to the patient; 2) the biological significance of the dose; 3) the potential future patient care; and 4) the actions to prevent recurrence. The patient and referring physician were notified. Region I dispatched an inspector to examine the circumstar:es surrounding.the misadministration, the licensee's corrective actions, and the licensee's actions to prevent recurrence.

An NRC inspection was performed on November 6, 1991. During the inspection, two violations were noted concerning 1) the failure to

. review the supervised individual's use of byproduct material; and 2) the failure to follow a procedure concerning written orders for performing iodine studies.

An Enforcement Conference with the licensee was held November 26, 1992. The NRC staff reiterated the importance of comprehensive actions-to be taken by the licensee to prevent similar incidents and stated that the conference should focus on the factual details surrounding the incident. The licensee accepted the NRC findings with the exception of an apparent violation concerning failure of the authorized users to review supervised individuals' use of byproduct material. The licensee stated that the incident was a result of failure to follow department procedures. The $3,125 civil penalty listed above was imposed-on December 12, 1991.

2) On June 1, 1990, NRC was notified that on May 14, 1990, a patient was intended to receive approximately 100-500 micrecurie of iodine-123 for a diagnostic thyroid scan but inadvertently receiveu 1.4 millicurie iodine-131 for a whole body scan.- The original order for the study was orally transmitted from the referring physician's office by telephone. The patient brought the written prescription to the hospital outpatient department and then proceeded-to the-nuclear medicine department. The prescription was not received in.

the nuclear medicine department until after the study was completed.

When the prescription was received, the error was discovered. 'The-administered radiation dose to the patient's thyroid from the iodine-131 dosage was approximately 1,820 rad, instead of the intended 4 rad from a 300 microcurie dosage of iodine-123.

The referring physician was notified, it is not known whether the patient was notified. The licensee's corrective actions included establishing a procedure requiring receipt of a written prescription by the nuclear medicine department prior to administering any_ iodine for studies.

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PENNSYLVANIA REGIONAL: CANCER CENTER.-INDIANA. PENNSYLVANIA x

1. OF PATIENTS:. One PATIENT: Mildred Colgan

.sVNOPSIS OF PLAIN DEALER' ARTICLE:

The Elajn Dealer reported that during treatment for cancer of the rectum using an Omnitron HDR Brachytherapy unit, Ms. Colgan was exposed to 200,000 to one million rads when a piece of the radioactive iridium-192 broke off and was-accidently left inside Ms. Colgan undetected for four days as opposed to only a few minutes. As a result of the overexposure, Ms. Colgan_dted November 20, 1992. The Plain Dealer also reported that the source went undiscovered until November 27, 1992, when it was detected in a waste truck entering _a landfill after the source in the catheter had been disposed of in normal trash.

INFORMATION KNOWN BY NRC PRIOR TO PUBLICATION:

NRC was notified December , 1992 that a 3.7 curie iridium-192 source was-left inside a patient for four days. The whereabouts of the source was not' known until it triggered a portal monitor at a waste f acility on December 1, 1992._ Three workers at the facility received approximately 350 mR each while locating and isolating the source. ,

The treatment took place on November 16, 1992 and the patient died on November 21, 1992. Based on the patient's medical-records, the preliminary conclusion by the NRC's medical consultant was that the patient either died as a result of exposure to radiation, or that radiation exposure was a majoincontributor to her death. Nursing home residents and staff, as well as-visitors, were exposed to radiation. Blood samples taken from employees, residents and visitors of the nursing home and employees of the waste facility were all-negative for acute radiation effects. In addition, Oak Ridge chromosome studies on blood samples from six individuals showed exposures were less-than the statistical detectable limit for any one individual.

Subsequent investigation found that a.short piece of the cable containing the iridium source had broken off and remained in-one of the catheters which had been implanted in the patient. Although-I wall-mounted area monitor alarmed when the treatment was completed, the licensee's staff believed the device was emitting a false signal and chose to ignore it.

REW INFORMATION FROM PLAIN DEALER:

None INFORMATION GATHERED SINCE PUBLICATION:

NRC Incident Inspection Team.

PATIENT F0ll0W-UP: An NRC medical consultant was sent to review the circumstances and interview both the patient's attending physician and the radiation oncologist. The referring physician and the patient's family were notified. The body has been exhumed and the NRC medical consultant observed the autopsy. Autopsy results are pending. The exposure of the other individuals exposed ha/e been evalutated.

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I MRC ENFORC[ MENT ACTION:

NRC is still investigating the case, however a Confirmatory Action Letter-

.(CAL)-was issued to modify the licen: . Additional enforcement action is- ~

being considered by the staff.

NRC ACT1QHE An NRC Bulletin issued to all Omnitron users on December 8, 1992 which requested that licensees either discontinue using the units or immediately implement the following actions in conjunction with any use of the unit: 1)

Survey patients with an appropriate survey-following treatment to confirm-that:

sources were removed: 2) Have written emergency procedures describing actions-to be taken and appropriate staff and resources available to implement-those proceduros should the source not return to the shielded container at the conclusion of treatment; and-3) Ensure that personnel are trained in both the routine use of the device and the emergrency procedures to return the source-to a safe condition.

An Information Notice issued to all medical licensees on December 17, 1992, informed licensees about concerns associated with releasing brachytherapy patients without positive assurance that all implant material has been removed- '

from patients before their release. NRC is continuing investigation of the incident in cooperation with the FDA.

LICENSEE HISTORY:

• The NRC license was issued on August 3, 1990.

• The inspection frequency for this licensee is three years; one inspection was conducted on 9/4/91.

• There have been no escalated enforcement actions for this licensee.

• There have been no previous misadministrations reported by this licensee.

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.t RIVERSIDE HETH0DIST HOSPITAL. COLUMBUS. OHIO _

1. OF PATIENTS: 413-PATIENTS: Twenty-eight patients were named by the Plain Dealer series.

SYN 0PSIS OF PLAIN DEALER ARTICLE:

The Plain Dealer reported that the radiation physicist at Riverside started -

using the wrong graph paper to calculate the strength-(activity) of the cobalt-60 teletherapy unit and as a result overdosed 413 patients for the period from September 1974 to January 1976. Of these 413 patients the Plain Dealer reported that radiation overexposure contributed to the death'. of 28 persons and one person lost a leg.

INFORMATION KNOWN BY NRC PRIOR TO PUBLICATION:

Or. April 18, 1976, the licensee reported that during the period March 1, 1975, to January 30, 1976, two hundred and fifty-five patients received radiation doses from a Co-60 teletherapy unit in excess of the intended dose (average of-nineteen percent with a forty percent maximum greater exposure than prescribed). The NRC Region 111 office conducted an investigation on April 20-22 and May 12-13, 1976, into the reported overexposures. The investigation disclosed that some three hundred and eighty-five patients received. exposures in excess of 10% above the prescribed amounts. These overexposures resulted when a hospital staff physicist prepared erroneous' data regarding the teletherapy unit source output, and used this data in computing patient exposure time information which was furnished to the radiation therapist physicians. Furthermore, the licensee management control system did not assure that the output of the teletherapy unit source was being accurately and competently determined and that patient exposure calculations were accurate.

An NRC medical consultant reviewed three autopsy cases and attributed excess radiation exposure as a major contributor to death in two cases (discussed bel ow) .

1. A 25 year old pregnant patient was being treated for Hodgkin's disease ,

with radiation therapy to the mediastinum, bilateral supraclavicular, and axillary areas and the neck. She received 19-treatments in 33 days. The initial calculated and actual doses are as follows: mediastinum, 3420 and 4 4708 rads; supraclavicular, 3708 and 5546 rads; and axillary 3519 and 4314 rads, respectively. The patient was admitted to-hospital 30 days after

< completion of treatment with increasing respiratory difficulty, characteristic ,

of a severe form of the adult respiratory distress syndro j me. Death occurred 60_ days after completion of radiation therapy attributed, H

by an NRC medical consultant, to acute radiation pneumonitis.

2. A 48 year old patient received Co-60 teletherapy treatment following removal of a pseudomucinous cystadenocarcinoma'of the left ovary. The patient received 33 treatments in 45 days with a Co-60 teletherapy unit. The prescribed dose was 2950 rads to the' entire abdomen with an additional dose of 1780 rads for the pelvic region (total of 4930 rads). The actual administered dose was 3676 rads to the entire abdomen and 6242 rads to the pelvic region.

Four months after completion of- treatment, the patient was admitted to the hosoital-with unrelieved diarrhea and low abdominal pain. Death occurred two weeks later with the major pathological findings of: radiation enteritis, reactive serofibrinous peritonitis, and stenosis and fibrosis of the bowel.

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It was determined by an WRC medical consultant that death was due to enteritis associated with fibrosis ulceration and peritonitis due to excessive radiation which was unrecognized until well after completion of therapy.

3. The NRC medical consultant also reviewed The case of a 52 year old' patient who received 34-treatments in 50 days to the neck for a total prescribed dose of 5100 rads. Recalculation showed the actual dose administered to be 5768 rads. The patient later developed metastases to the mediastinum after which the patient received 25 treatments to the midline chest for a total prescribed dose of 5000 rads. The actual dose delivered was 5596 rads. Death occurred approximately one year later. It was determined by the NRC medical consultant that death was due to the progress of his cancer.

The staff briefed the Commission on the incident on August 2, 1976.

Subsequently, on May 19, 1977, NRC issued a proposed rule to require teletherapy licensees to: 1) have a qualified expert perform full calibration measurements on each teletherapy unit at least once each year; 2) perform spot-check measurements on the output of their units at least monthly; and 3) report to the NRC radiation doses that differ from the prescribed dose by more than 10 percent. The fir.al rule, which became effective July 9,1979, required 1) full calibration measurements on teletherapy units at least once each year and following any repair of the unit that includes removal of the source or major repair of the component associated with the source exposure assembly and prior to treating humans; 2) spot check measurements at least monthly; 3) correction of calibration of teletherapy output for physical decay at intervals not to exceed one month: 4) dosimetry systems used to calibrate the teletherapy units are properly calibrated; and 5) the licensee to determine that a person is an expert qualified by training and experience to calibrate teletherapy units. y EEW INFORMATION FROM PLAIN DEALER:

Number of deaths.

INFORMATION GATHERED SINCE PUBLICATION:

NRC's Medical Visiting Feiltw contacted the deputy coroner. REACTS and the deputy coroner indicate 10 deaths.

PATTENT FOLLOW-UP:

Autopsy reports of three individuals were reviewed by the NRC medical consultant. A decision to discontinue patient follow-up was made after these reviews.

NRC ENFORCEMENT ACTION :

On July 14, 1976, the NRC issued an order modifying the license for Riverside Methodist Hospital. This order required the licensee to conduct full calibrations of each teletherapy unit at intervals not to exceed one year, spot checks of the teletherapy units at intervals not to exceed one month, and maintain records of all calibrations and spot checks. In addition, an NRC bulletin was issued to all NRC-licensees who used NRC-licensed teletherapy units. The bulletin advised licensees to perform a comparison test between unit measured output and calculated output. Where there were variances, the licensee was to perform a full calibration. Agreement States were informed of the NRC action and similar actions on their part was requested.

In an effort by NRC and licensees to verify the calibration methods of the output of the licensee's teletherapy units, thermoluminescent dosimeters were sent to about 300 licensees which were returned for evaluation. Based on the 11 i 1

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- evaluations, teams of NRC. inspectors were sent to all licensees in which the exposures-differed by.1 5% compared to the expected' exposures. - Al l -: .

discrepancies were satisfactorily resolved.

-LICENSEE HISTQRY:

=. The NRC(AEC) license was issued for teletherapy on November 30,- 1965, and terminated on May 3, 1982.

• Other therapeutic misadministrations A therapeutic misadministration of I-131 occurred on August 2,1991. _ A

-10 mci dose of I-131 Nal was ordered for a hyperthyroid patient, and only 8.7_ mci was administered. The cause of the event _was failure to' assay the dosing container post administration to ascertain that the:

entire prescribed amount was administered to the patient. The missing 1.3 mci was found on the rubber septum of the dosing vial. The lice,see is taking appropriate corrective action to prevent future incidents of-this nature. The referring physician was notified and decided not-to return the patient for additional 1-131.

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IRIPLER ARMY HOSPITAL. HAWAII

1. OF PATIENTS: One PATIENT: Rensly Phillips SYNOPSIS OF PLAIN DEALER ARTICLE:

The Plain Dealer reported that in June 1990,- a technologist gave Ms. Phillips, a lactating woman, a dose of iodine-131 without asking if she was breastfeeding. The patient's infant daughter then ingested the breast milk, destroying the baby's thyroid gland. The Plain-Dealer also reported that Ms.

Phillips was not-informed of the mistake until she read about it in a newspaper in Guam.

INFORMATION KNOWN BY NRC PRIOR TO PUBLICATION:

On June 19, 1990, a mother who was breastfeeding inadvertently received a dosage of 4.89 millicurie of iodine-131 that resulted in an unintentional-radiation dose to her infant's thyroid gland estimated at 30,000 rad and a dose to the infant's whole body of 17 rad. The error was detected on June 21 when the patient returned to the medical center for a whole body scan. The root cause is that the technologist and physician failed to confirm that the patient was not breastfeeding prior the administration. . Part of_this communication was hindered by the fact that the patient arrived at the medical center from a very remote South Pacific island (Truk). Communication between island physicians was poor and Tripler physicians were not aware -that the mother had given birth on June 1, 1990.

The licensee's corrective actions included revision of quality assurance procedures to more accurately document information regarding pregnancy and breastfeeding status of female. patients.

NEW INFORMATION FROM PLAIN DEALER:

None INFORMATION GATHERED SINCE PUBLICATION:

None PATIENT FOLLOW-UP:

An NRC medical consultant visited Tripler, met with the patient's physician and staff then analyzed the information. The licensee notified the patient and arranged for long term follow-up care of the infant.

NRC ENFORCEMENT ACTION (IF ANY):

An Enforcement Conference was held and a Notice of Violation (NOV) and Imposition of Civil Penalty (CP) in the amount of $5,000 was. issued for l violation of 10 CFR 35.25(a)(2) for failure of the supervised personnel to-follow procedures and instructions of the supervising authorized users. The violation was categorized as a Severity Level I problem (the most significant level). After reviewing the licensee's response to.the NOV, NRC staff reconsidered the amount of the'CP and consulted with the Commission. An Order imposing a CP in the amount of $2,500 was issued and paid by the licensee.

13

LICENSEE HISTORY:

. The license was issued prion to 1960.

• The license is inspected annually

= Other Escalated Enforcement Actions

a. Enforcement Conference held Sept. 24, 1981, no civil penalty An inspection was performed on July 23, 24, and 27, 1981. Four-patients appeared to have been administered Tc-99m containing more than 5 microcuries Mo.99 per dose.

b. Severity Level 111 violation issued Dec. 30, 1992. No Civil Penalty was issued. An inspection was conducted November 4 and 5, 1992.

There was a failure to adequately inventory iridium brachytherapy seeds between August 1989 and June 1992, resulting-in 14 seeds-being unaccounted for. The fourteen seeds had the potential to cause an unplanned exposure.

• Other therapeutic misadministrations

1) On June 17,1986, a 54-year-old female patient received a dosage of 3.09 millicurie of iodine-131 instead of a prescribed dosage of 50 microcurie iodine-131 for a thyroid imaging procedure. The misadministration was the result of misreading the consultation sheet. The radiation exposure associated with the administered dosage was estimated to be 2,472 rad to the thyroid, 0.43 rad to the ovaries, and 1.45 rad to the whole body. The patient was notified and hospitalized for observation. The licensee stated that the exposure to the thyroid might result in some degree of impairment in its function.

2) On April 26, 1991 NRC was notified of a therapeutic misadministration that occurred on October 16,1987, a 30 year old female was prescribed intracavitary brachytherapy treatment for cancer of the cervix. The prescribed treatment time was 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br /> for a total of 5300 cGy to the vaginal apex. The radiation oncology service physician inadvertently scheduled the removal for 74 hours8.564815e-4 days <br />0.0206 hours <br />1.223545e-4 weeks <br />2.8157e-5 months <br />, but detected the error and removed the sources at 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br />. The resulting dose was 7632 cGy. The referring physician was notified October 26, 1987 and offered no comments. Neither the patient nor her family were informed'of the error. The patient later died on

~3 February 11, 1990 due to urosepsis secondary to renal obstruction by recurrent tumor. NRC conducted a special inspection during the period June 3 through July 26, 1991. The two identified violations l

were not cited because the criteria specified in the Enforcement 1- Policy for non-cited violations were satisfied.

1 4

14 i

w . , . - ---

UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS.~ MADISON. WISCONSIN

1. OF PATIENTS: One PATIENT: Lois- Nelson SYNOPSIS OF PLAIN DEALER ARTICLE: The Plain Dealer reported that in 1986, during treatment for bladder cancer, Ms. Nelson's digestive tract was severely burned, and as a result of the trauma, Ms. Nelson's husband Robert committed suicide in December 1991.

INFORMATION KNOWN BY NRC PRIOR TO PUBLICATION:

In February 1989, NRC Region 111 received an allegation concerning Ms.

Nelson's possible overexposure in 1986. An NRC inspector then contacted _the -

State of Wisconsin's Department of Health and Social- Services-and was informed that the source of Mrs. Nelson's radiation treatments was a linear accelerator.

NEW INFORMATION FROM PLAIN DEALER:

Husband committed suicide INFORMATION GATHERED SINCE-PUBLICATION:

None PATIENT FOLLOW-VP:

None, not under NRC reguylatory purview.

NRC ENFORCEMENT ACTION (IF ANY):

None, linear accelerators are not under NRC regulatory _ purview.

LICENSEE HISTORY:

• The licensee has an NRC (AEC) license since August 8, 1956

• The license is inspected annually.

• Escalated Enforcement Actions

1) EA 86-179, $1250' civil penalty imposed following loss of seven iridium-192 seeds used in animal experiments conducted between June 26 and August 21, 1986,

2) EA 90-098, $7500 civil penalty imposed after a May .2,1990 inspection found that on two occasions during the period April 1989 through March 26, 1990, a High Dose Rate' Afterloader was used to .

treat patients and a trained operator:was not present' and at least'

. 35' treatment plans did not have the treatment time calculations independently verified.

• Other therapeutic misadministrations

1) On February 8 and March 16, 1990, NRC was notified of two therapy i- misadministrations that occurred on February 7 and'Harch-15, 1990, respectively, due to a common cause. Erroneous information was entered into a computer that controlled the treatment location of sealed sources used in a remote afterloading brachytherapy device.

The second event resulted in the wrong part of a patient's body I

receiving a therapy dose.

In the first case, a 42-year-old patient was scheduled to receive a total of four treatments of 1,620 rem each, two to each side of. the vaginal arer, for a total of 3,240 per side. The first dose to the right side was correctly administered, but erroneous treatment parameters was entered into the computer for the second dose,

! 15

.t lresulting in-a single dose of 2,500 rem _to the right side; therefore, the' total dose to the right side-was 4',120. rem or 27% -

higher than prescribed.

The.second case involved a 66-year-old patient that was scheduled. to-receive a total of four treatments of 400 rem each to the bronchial area. Incorrect information was_ entered into the computer for the first_ treatment,- resulting in the incorrect placement of the iridium-192 source. The treated area was about 3.5 inches from the intended area. When the error was discovered, the licensee repeated the procedure, and the remainder of the treatments were performed ,

without incident.

The . licensee prepared a quality assurance / quality control ~ program to include dual verification at several key intervals of treatment planning and admi-istration. In addition, training of personnel was verified by examination. The referring physicians and the patients-involved were notified.

2) On November 27, 1991 NRC was notified of a misadministration involving the licensee's MicroSelectron HDR afterloading brachytherapy device (HDR) which occurred on November 27, 1991, to a male out-patient during final treatment- for cancer of the nasal septum. The treatment card was taken from the wrong patient-file.

After the treatment began it was noted that there was a. disparity between the one and one-half minute treatment' time indicated the prescribing physician and the 400 second treatment time indicated by the physicist. Based on the disparity the physician directed the physicist to stop the treatment. The physicist and physician then discovered that the wrong treatment card had been used.

As a result of using the wrong treatment parameters the patient's lips received an excessive dose of 76 rads. The physician informed the patient of the error. As of December 17, 1991, the patient had not exhibited _any adverse effects as a result of the misadministration.

NRC conducted a special safety inspection on December 17,fl991 in

! response to the therapeutic misadministration. An NRC medical consultant was contacted to evaluate the case. No violations of NRC requirements were identified during the course of the inspection.

16

, , - , , _ . _ . ... ,..m 3.~.- - - - ' * " ' " ' ' " " " ' '

, ENCLOSURE 4' f ffff W h[@b RADIATION REGUL ATORY AGENCY 4814 South 40th Street Phoenix, Arizona S5040 DATE: /

I FACSIMILE TO: '/M /' f f # #" /-

FROM: ##7 7 ~

k FACSIM1LE NUMBER: (602) 437 0705-VOICE NUMBER: (602) 255-4S45

SUBJECT:

IW CId @b /

COMMENTS:

wedh / ]% eal L e i d a N a,p N //

strif no<)/h.*bsd ObcW dt' case / s,J A + L 4 nes A 4/ 4 L A 4 L1'b Ste -

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& /99D:

A N A ffn*< l' [J Y$ . ife cfdhe da $ N bu AJMA &

Yl9/ Sag sYed h NUMBER OF PAGES INCLUDING COVER SHEET: I[

hsd AMl xJsufl As& /nj)s te Ll L T/ w 4

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ENCLOSURE 4

• SIGNIFICANT CASES IN ARIZONA AS REPORTED IN THE PLAIN DEALER NEWSPAPER ARTICLE SERIES

1. Name of Facility:

Desert Smaritan Hospital and Health Center, Mesa, Arizona.

2. Number of Patients involved: ,

One.

3. Name of Patient:

F; Mrs. Deborah Lane. .

4. Synopsis _of Plain Dealer Article:

In November, 1989, homemaker Deborah Lane, mistakenly received - 100 .

millicuries instead of 100 microcuries of lodine-131 for a thyroid scan.' The overdose, equal to 1000 times me.e radiation than her doctor had prescribed, was caused by a series of mistakes at the hospital.

11 was enough to contaminate the Lane's car, home and family.  :

Lane had to be placed in a special isolation area while the radiation wore off.

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O ENCLOSURE 4 l

She was also asked by the hospital officials to supply a list of everyone sho had ,

contact with, especially the ones she kissed. ,

I When Lane finished the list, the hospitals chief nuclear medicine technologist responded, 'My, you're a kissy person, aren't you?'

The Arizona Radiation Regulatory Agency (ARRA) fined the hospital $12,000,.00.

5. Information Known by the State Prior to Publication: --

1 included- as enclosure 1, 3 onclosures sent to Mr. Jack Horner, Region V-Agrooment State Liaison and enclosure 2, (NUREG-0090, Volume 13, No. 2, April - June,1990 AOR Reports).

6. New information From Plain Doalor Article:

None.

7. Information Gathered Since Publication:

E Discussions with the current Radiation Safety Officer indicate that a suit initiated by Deborah Lane against Desert Samaritan Hospital had boon settled and the amount of settlement was unknown.

B. Patient Follow up:

e

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ENCt.0S0RE 4 ,

I No action has been taken by at this Agoney- to follow up on the patients -  :

i condition. This is a medical issue and is probably being addressed by Desert Samaritan Hospital and the responsible physician. l i

9. State Enforcement Action:

i ARRA conditionally imposed a civil penalty of $14,000.00,- mitigated $2.000,00  ;

of it and finally-imposed .a civil penalty of $12,000.00. The S12,000.00 civil penalty was paid on January 24,1990.

10. License Hintory; No significant findings which would indicate a generic problem that would hdvo caused the problem which occurred on November 1,1989.

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ENCLOSURE 4 c.

'=~ e'5 i RI Z T N> A .

RADIAiloN Rf GUL A70HY ACINCY cheries t. v ovo.e

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Phoents, Atitona 85040 $02) 2$5 4N!,

4814 South 40 Street May 2,1990 Mr. Jack W. Horner Regional State Agreements Representative U.S. Nuclear Regulatory Commission, Region V 1450 Maria Lane Suite 210 .

Walnut Creek California 94596 Deur -Hswer:Mr.fah Enclosed for your information is an Abnormal Occurrence Report (AOR) (Enclosure No.1) for the Misadministration which occurred at Desert Samaritan Hospital (License No. 7106) on November 1.1989. Also enclosed is the written summary (Enclosure No. 2) and a list of chronological events (Enclosure No. 3) to include actions that were taken by Syncor International Corporation, the radiopharmacy which supplied the lodine 131.

If you have any comments or questions, plea e contact this Agency at (602) 255.1845.

Sincerely, gh7. N9/' '

Charles F. Tedford Director Enclosures ww:CFT:svc cc. Vandy hiiller Assistant Director State Agreements Program l

Lloyd Bolling l

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• ENCLOSURE 4 6

ENCLOSURE I EVEtiT P.EPORT FOR PATERI AL LICENSEES win /<&bm <,J n sahs.,i d / A spix d -f arame '

i m a d. w a d ,,a a Ass Ap.r/ p% 9ams A *

1. / _ PAGE NO. /

LICEftSEE I4AMEA 4 LICEtiSE NO.

Ncrge/

LOCATION OF EVENT FIELD ,_

~

FIXED 1 ISOTOPE AND sM3DNT IS0 TOPE 7 4 - /f/ AM3UNT Neen/[aut/d iv " VED TYD P'DA'IE YR F RTORT DATC YR A 0 trier't CENSEES NAME + w r's o s a/dq/. #

ff_ LICENSE no. ~f- t'{I' hPE OF EVENT _.

CHECK ALL BLOCKS THAT PERTAIN 4

( ) LOSS OF PACKAGE EFFECTIVENESS OR CONTAMINATION

( ) THEFT OR LOSS OF LICENSED !%TERI AL

) OVEREXPOSURE OF INDIVIDUAL TO RADIATION

(

( ) OVEREXPOSURE OF INDIVIDUAL TO RADI0 ACTIVE MATERIAL

( ) EXCESSIVE LEVELS OF RADIATION OR CONCENTPATIONS OF RADI0 AC PATERIAL '

4

( ) SAFETY FAILURE OF GL DEVICE

( ) LEAKING SOURCE

, (.)/) MISADMINISTRATION ,

( ) URANIUM MILL OCCURRENCE

( ) TPANSPORTATION INCIDENT

( ) OTHER 4

Reciprocity GL inf omation Agreement State or NRC License MfM" or N/A

'DESCRIP110N OF EVENT

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ENCLOSURE 4 ENCt.05URE 2 J

AC,RT'EMENT STATE MEDICA 1 DI AGNOSTIC MISADMINISTR ATION:

On November 1,1989, at Desert Samaritan Hospital, Phoenix, Arizona, a patient schedu for the administration of 100 microcurie capsules of Iodine-123, was administered 100 millicuries of liquid Iodine 131 and sent home for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> until normal imaging was scheduled.

When the patient returned the next day (November 2), the imaging camera flooded out, which indicated a large overdose, and the Arizona Radiation Regulatory Agency (ARRA) was immediately notified. The patient was immediately hospitalized and isolated, as is the case for thyroid ablation dose patients, The patient's family was contacted and bioassays were obtained to determine lodine 131 thyroid burdens. The Chief Nuclear Medicine Technologist and an Agency representative performed a survey and decontamination of the patient's home. Wipe tests were obtained to verify the efficiency of the decontamination efforts. The family thyroid burdens, while above the action level for radiation workers (0.4 Ci), were not considered a serious health threat.

Discussions with management, Chief Nuclear Medicine Technician, and the two Nuclear Medicine Technicians indicated the following violations:

1

> 1. The patient had been administered a therapeutic dose of lodine 131 and allowed to go home (an umestricted area).

2. The Iodine 131 dose had not been assayed in the dose calibrator prior to adtninistration.

3. There was a failure to compare the lodine-131 dose label with the physician's order, f

4 The incoming radiopharmaceutical package, when received, had not been surveyed. .

5. Records for incoming radiopharmaceuticals were not mamtained in an adequate fashion.

These actions were required by hospital license conditions but were not performed because of a series of human errors. These violations were also listed in the Notice of V sent to Desert Samaritan Hospital.

To prevent reoccurrence, the Agency placed an order on the hospital which reduced the. .

total amount of Iodine-131 that could be possessed at one time from 500 millicuries to 100 microcuries (0.1 millicuries). In addition, the Agency proposed a $14,000 Civil Penalty 1

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ENCLOSURE 4 against the hospital for failure to perform required procedures.

The Agency also investigated Syncor International, Inc., the radiopharmacy that dispensed The investigation showed that the records of the radiopharmaceutical dose to the hospital.

telephone order for the Iodine 131 were not written legibly such that the units could be differentiated (uCi or mci); the type of intended medical procedure (diagnostic or Neither the hospital employee who placed the order nor the therapeutic) was not shown.

pharmacy person taking the order could be identified. The Agency cited Syncor and irnposed an order which limited them to not dispensing any dose of Iodine-131 in excess o one rnillicurie unless a written order from the client licensee was in the possession of the radiopharmacist dispensing the dose.

The radiopharmacy responded on December 11,19S9. and informed the Agency that the following policies would be observed when Iodine-131 therapy orders were received and dispensed:

1. All orders for lodine-131 therapy doses must be taken and confirmed by a pharmacist that the order is for a therapy dose. E

2. A patient name must be obtained at the time that the order is taken and must be entered on the prescription label before the dose is dispensed.

3. All Iodine 131 therapy doses must be calibrated using the K factor and must be within 10 percent of the prescribed dose.

Additionally, it was suggested that all liquid lodine 131 therapy doses be dispensed in a plastic screw top septum 4ial. A therapy administration straw, which can be inserted through the septum without opening the vial, can be used in conjunction with the vial The Agency issued a license amendment to Syncor on January 10,1990 which stated the following:

1.

All orders for lodine 131 in quantities greater than one millicurie shall be taken-by a pharmacist who shall verify the dose as a therapy dose and repeat the order back to the individual that placed the order.

2. The patient's name shall be obtained when the therapy dose is ordered and shall be on the prescription label prior to dispensing the dose.

3. The name of the client representative ordering the therapy dose, the patient's .

2

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ENCLOSURE 4

'E. order shall be name and procedure, and the name of the pharmacist accep,:';

recorded on the telephone order pad.

The order limiting Syncor dispensing any dose of Iodine-131 in excess of one millicurie v.ithdrawn on January 9,1990, because of Syncor's internal policy, 20-22,the 1990.Agency's license amendment, and an inspection conducted by the Agency on November On January 10, 1990, the Agency received a letter from Desert Samaritan Hospital admitting-to Vivintion Nos.1,2,3, and 5 and disagreeing with Violation No. 4 (package not being-surveyed). Contained in the letter were amended administrative procedures for the Nuclear Medicine Department. The Agency sent a letter back to Desert Samaritan Hospital mitigating Violation No. 4 from 53,000 (a Category II violation) to S1,000 (a Category violation) and imposing a resultant civil penalty of 512,000. A check 24,from 1990.Desert Samaritan Hospital in the amount of $12,000 was received by the Agency on January 31,1990, at An enforcement conference was held with Desert Samaritan Hospital on January which time the findings of the civil penalty were readdressed. A letter from Desert 15, 1990, recommitting to Samaritan Hospital was received by the Agency on February amended Nuclear Medicine Department administrative procedures. Based on this letter, amended Nuclear Medicine Department administrative procedures and the enforcement conference, the order restricting Iodine-131 possession limits to 100 microcuries was rescinded on March 9,1990.

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3

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M n - 2 . - n.

O

' ' ENCLOSURE 4 l CHRONOLOGY OF EVENTS 1131 INCIDENT 1000 Wednesday. November 1,1989: A patient scheduled for the administration of 200l microcurie capsules of Iodine 123 was administered 100 millicuries of liquid I 131 and i sent home.

0900 Thursday, November 2,1989: Patient returned for thyroid scan. Results of the scan indicated a problem. ARRA notified by telephone that a diagnostic misadministration ha occurred at Desert Samaritan. Initial information included the information that the patient was to have been given a diagnostic dose of 100 microcuries of Iodine 131 f a substernal thyroid scan but when the scan indicated a larger amount (later determined to be 100 millicuries) it was decided to notify the Agency.

1400 - 1700 Thursday, November 2,1089: ne Chief Nuclear Medicine Technologist and an Agency representative performed a survey and decontamination of the patients home.

13 wipes were obtainea to determine efficiency of the decontamination efforts. A bioassay was performed on all residents of the patients home. All had a detectable uptake of lodine. Patient was hospitalized in isolation following routine hospital procedures for ablation dose patients.

0900 Friday, November 3,1989: Conducted interview of the Chief Nuclear Medicine -

Technician and Management of Desert Samaritan Hospital.

1000 Friday, November 3,1989: Called the NRC Region 5 and advised of situation.

1100 Friday, November 3,1989: Smear results received indicating that decontamination was successful except for the patients Master bath sink counter top and telephone. The Chief Nuclear Medicine Technician was notified and stated that she would inform the patients husband.

1300 Friday, November 3,1989: Conducted interview of the radiopharmacy Manager.

" Saturday Morning. November 5,1989: Patient less than 5 mr/hr at one meter and was m discharged from Desert Samaritan llospital.

Monday Morning, November 6,1989: Called Mr. Jack Horner and informed him of the situation.

'0900 Monday, November 6, 1989: Returned to Syncor and interviewed all '

radiopharmacists-and drivers imlalved in the preparation and delivery of the dose to Desert Samaritan Hospital.

Tuesday November 7,19S9: Syncor Imernational Corporation issues nationwide I-131 thecpy order policy.

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ENCLOSURE 4

a. All orders for 1131 must be taken by a radiopharmacist and confirmed that it is a therapy dose.

b. Patient name must be obtained and on the prescription label before dose is dispensed.

c. All 1131 therapy doses must be within 10% of prescribed dose.

d. Suggested all liquid 1131 therapy be dispeased in a plastic screw top septum vial.

0830 Thursday, November 9, 1989: Returned to Desert Samaritan Hospital and individually interviewed both technicians involved while in the presence of- DSH y' management.

1000 Thursday, November 16, 1989: Notified the Chief Nuclear Medicine Technologist of Desert Samaritan Hospital that the Agency considers the incident to fall under the requirement of R121423 in which a written report must be given to the Agency within one month vis-a vis reporting a diagnostic misadministration no later than 10 days after the end of the quarter in which the misadministration occurs.

1615 Thursday, November 16, 1989: Telefaxed draft copy of the results of interviews to Mr. Jack Horner NRC Region 5.

November 21,1989: Agency placed an order on Desert Samaritan Hospitallimiting total I.131 to 100 microcuries.

November 22,1989: Agency placed an order on Syncor modifying lodine 131 procedures by license amendment.

"The licensee shall not dispense any dose of Iodinc.131 in excess of one millicurie unless a written order from the client licensee is in the possession of the radiopharmacist dispensing the dose.*

December 5.1989: Notice of violation and p_roposed civil penalty letter sent to Desert Samaritan Hospital identifying 5 violations:

1. Release of patient administered 100 mi!!icuries of Iodine 131 to an unrestricted area. 54,000 civil penalty proposed.

2. Failure to assay dose prior to administration. 53,000 civil penalty proposed.

3. Failure to compare dose label with physicians order. S3.000 civil penalty a proposed, Failure to perform survey of incoming radiopharmaceutical package. 53,090 l 4.

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. ENCLOSURE 4 civil penalty proposed.

5.

Failure .s maintain acquisition records. 51,000 civil penalty proposed.

January 9,1990: Order to Syncor rnodifying lodine 131 procedures terminated, January 10, 1990: Syncor amendment #54 issued modifying lodine 131 order proced a.

All Iodine 131 orders = to or > 1 millicurie are taken by a pharmacist who shall verify the dose and repeat the order back to the individual orderine, the dose,

b. Patients name obtained with therapy dose ordered and put on prescription label.

c. Name of client representative ordering dose, patients name and procedure and name of pharmacist accepting the order placed on the order pad.

January 10, 1990: Letter received from Desert Samaritan Hospital admitting to findings 1, 2, 3, & 5 and refuting finding #4 and amending administrative procedures of the nuclear medicine department.

January 22,1990: Letter from the Agency to Desert Samaritan Hospital mitigating fin

1. 4, to a 51,000 civil penalty, and order imposing a civil penalty of 512,000.

January 23,1990: Performed specific inspection of Desert Samaritan's dose calibrator an its associated records, and survey meters, January 24, 1990: Received 512,000 civil penalty payment from Desert Samaritan Hospital.

February 15, 1990: Received letter from Desert Samaritan Hospital with commitment to change procedures (attached).

March 8,1990: Draft order to, and amendment of, Desert Samaritan 1:a:.pital license.

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g/ q/ 3[ 3 ENCLOSURE 4 -

MC - The NRC conducted a special inspection on June 27-29, 1990, to review the circumstances of the misadministration and to evaluate the licensee's radiation safety and management control programs (Ref. 7). The inspection also covered an earlier therapy misadministration in which a patient received less than the intended dose, In this misadministration, a patient received a dose that was 12 per cent less than that intended during a treatment series February 15 through April 3, 1990. A Notice of Violation was issued for two instances of failure to report the misadministrations within the required time period. The inspection also identified a concern about staff shortages that may adversely affect the licensee's radiation therapy program. The NRC requested the hospital's response to this concern.

This item is considered closed for the purposes of this report.

AGREEMENT STATE LICENSEES Procedures have been developed for the Agreement States to screen unscheduled incidents or events using the same criteria as the NRC (see Appendix A) and report the events to the NRC for inclusion in this report. For 'his period, the Agreement States determined that one of these events was an abermal occurrence.

AS90-1"Medien1 Diaanostic Misadmini_stration Appendix A (see the general criterion) of this report notes that an event involving a moderate or more severe impact on public health and safety can be considered an abnormal occurrence.

Oate and Pl aceTNovemFeF1,1989- Desert Sadiar~itarr Hospital P Pho~e'n~ii}# 'rTioTa7 Nature and Probable Consecuences - On November 1,1989, a patient scheduled for the administration of 100 microcurie capsules of iodine-123 for a diagnostic thyroid scan was mistakenly administered a therapeutic dose of 100 millicuries of iodine 131 and sent home for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> until normal imaging was scheduled, When the patient returned on November 2, the imaging camera flooded out, which indicated a large overdose. The hospital immediately notified the Arizona Radiation Regulatory Agency (ARRA). The patient was immediately hospitalized and isolated, (the standard practice for thyroid ablation patients). The patient was discharged on November 5, 1989.

The patient's family was contacted and a bioassay was performed to determine the thyroid body burden of each family member. The thyroid burdens were above the action level for radiation workers (0.4 microcurie) but the level was not considered a serious health threat to any family member.

9

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J's"-25-97 ENCLOSURE 4 i ted the ,

A hospitt.1 employee and an ARRA representative surveyed and decon Wipe tests were used to verify the efficiency of the patient's house.

decontamination. The hospital Rqu or Causfei J There were several causes for this event.

staff:

o-did not assay the dose in the dose calibrator prior to administering it, o

did not compare the iodine 131 dose label with the physician's  ;

order, and .

o did not maintain adequate records of incoming radiopharmaceuticals.

In addition, ARRA cited the hospital for allowing a patient who had been administered a therapeutic dose of iodine 131 to go home.

Syncor International, Inc., the radiopharmacy that dispensed the dose:

did not. record the telephone order for iodine 131 legibly 50 that o microcurie and millicurie could be differcrc.tated,.

the units for and o

did not record the type of intended procedure (diagnostic or therapeutic).

' Actions Taken to Pr,_tyent Recurrence Acenty . The ARRA placed an order on the hospital that reduced the posses The ARRA also cited Syncor and imposed an orde any dose of iodine-131 in excess of 1 millicurie unless a written order the client licensee was in the possession of the radiopharmacist dispensin the dose.

Later, the ARRA sent a Notice of Violation to the licensee and .

imposed a civil penalty in the amount of $12,000.

Hnspital - The hospital amended its Nuclear Medicine The Department order restricting iodine-administ procedures and paid the civil penalty in full.131 possession l 1990, Radioid.arcacy - The radiopharmacy adopted policies to be used when io The ARRA issued a license therapy orders were received and dispensed.

amendment incorporating required procedures for orders for mo millicurie of iodine-131.

could be dispensed was withdrawn by the ARRA on January 9, 1990.

This item is considered closed for the purposes of this report.

• s < < ,+e, 10

• Enclosure 4

.) / ddwaras DEPARTMENT OF HEALTH lQ?]\

V; b .6'[ 4816 WFST MAnKH AM $7rtEFT

• LITTLI. HOCK. ARKANSAS T??0'r38G7 TcLc8PONC AC $01612000 6A JoYCELYN CLDE 54S. M D i% CLMON c4CCTOR GN %c4 January 11,1993 Carlton Krammerer, Director, Ornce of State Programs U. S. N ucleu llegulatory Commission Washmgton, DC 20555

Dear Carlton:

This letter in in response to the request for comments regarding statemenLs attributed to me in the series of articles which appeared in the Cleveland Plain Dealer.

In the series of articles, I found reference to comments attributed in me in two places-

1. I do not know the date of this article,it was entitled "X ray Victim Cringes at Idea of Safe Doso". I am quoted as indicating that 1 believe some of the problems the public has with radiation issues are associated with a lack of understanding of the iasues, which is, in my opinion, directly related to the amount or type of public information that has been made available. Those of us dealing with radiation issues may not have been as proactivn as we should have been in providing accurate, clear, and unbiased information to the public about radiation uses, risks sind uncertainties. I think we have been slow to respond to comments that misdirect or mislead or to inaccurate information. The quote attributed to me appears to be accurate although it was made in reference to LLW issues and not medient issues.

11. Article dated 12-13 92 entitled " Maryland Hushed Up Twenty Patients Deaths" This section addressed my concern with the misadministration rule; the fact that Arkansas does not routinely levy Snes for noncompliance and, that we may not have an effective regulatory structure

.s $9a/ c,W-9 <%.qy "

Carlton Krammerer Enclosure 4

• Pega

• The first part of the quote is accurate in terms of what I naid but it is taken somewhat out of enntext. As best I recall the conversation 1 addressed the fact that the States sometime disagree with the NRC on issues. The statement had to do with regtdation promulgation and policy development. During this discussion I referred to the fact that the first misadministration rule included diagnostic misadministration reporting requirements which created problems because we also regulate x rays and, to be consistent, had to develop diagnostic misadministration rules for x-ray - which proved difTicult.

• Regarding the fact that we do not routinely fine licensees or i egistrants: While true, I take serious issue with implication m the article that this means a less serious commitment to radiation safety on our part. To my know, edge, they did not talk to Arkansas' medical consumers to determine if they had concerns about the health care services they receive. It is the policy to fine only for severe infractions of regulations that imply or implicate malfensance or when a facility will not comply with the regulatory requirements.

I believe that my statement was misunderstood and/or misused by the icporters.

We have an aggressive inspection prograrn and violations of regulatory requirements are identified; but, violationo having the potential for health or safety impacts either on employees, patients or other individuals in the facility are rare. % hen these hnve occurred we have fotmd facilities to be responsive and responsible in their reaction to the circumstances, quickly bringing them to correction.

Arkansas has several small hospitals in rural areas without strong financial bases that are providing axcellent medical care to our population in these areas. We believe our policy represents the best interesta of the health of our people by fostering compliance through cooperation and education, not financial penalty.

While we have not had an incident in our state of the nature of the incidents reported in the articles in The Plain Dealer, certainly no one can guarantee that we would never have such an incident in the future. However, I remain confident that we have the regulatory struct ure, philosophy and commitment in place such that the potential for these events is minimal and if an incident occurs necessar remedial activities will be available to quickly and effective ninimize the impact of the event.

Sincerely, GE k.

O eta J Jirus. Director Division of Radiation Control and Emergency Management i

" Enclosure 4

. : UNWn

,_ STATIFQFTELtNOIS DEPARTMENT.OF: NUCLEAR SAFETY 103$36Ts@ PARK D. RIVE

{h Jim Edgar SPRINC(NE$00/'LLyO}562704 N . Thomas W. Orteiger -

Gover6er Director 21Ec7E,y.g-[f)D)

~ y. 4. ,. . -

January 15, 1993 Mr. Jim Hyers State Agreements Program U.S. Nuclear Regulatory Commission Washington, D.C. 20555 RE: YOUR FAX REQUEST FOR INf0RMAil0N DATED DECEMBER 22, 1992-

Dear Mr. Hyers:

The Plain Dealer article on page 14A of the Sunday, December 13.11992 edition referred to a statement'made by Wayne Kerr as follows: "Similarly, Illinois, which has one of the larger agreement state programs and licenses about 400 medical institutions, has-fined just one medical institution for-a-radiation violation since becoming an agreement state in June 1987.

Only one medical institution has been fined- for violations of its radioactive materials license. However, Illinois has used other enforcement methods to achieve corrective measures. These include management conferences and orders ts cease use of radioactive material. Also, civil penalties (fines) have been issued to 36 facilities for. violations regarding -

unaccredited individuals. four of these were nuclear medicine and three were radiation therapy.

All of the other references to the State of Illinois that appeared in the Plain Dealer articles were for a facility and individual (V. A.- Medical Center. Hines, IL) that were under U.S. _ Nuclear Regulatory Commission license not the State of Illinois jurisdiction.

If you have any further questions, feel free to call me at-(217)-785-9935.

Sincerely.

.r. 0, < W Steven C. Collins, Chief Division of Radioactive Materials

-SCC:sjk-g_._.

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

.. lo:-n '92 1tc oiat.) Ito t lu FAr. F701EO lO f 1El H:u919 f."I st n 21~6 K'l E f4 C t. 0 5 U R E 4

)J /* 6 DIVISION OF RADIATION PROTECTION Raleigh, North Carolina Phone: 919/571-4141 FAX 919/571-4148 FACUIMILE TRANGHITTAL COVER S!!EET

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,o MAltYLitND DEPARTMENT OF TiiE ENVIltONMisNT ,

ItadiologicalIIealth Program TO: Jim Myers - USNRC FROM: Carl Tnimp, Jr.

(410) 631 3301 DATE- January 21,1993

1. N AMI. OF FACl!.lTY: Sacred Heart Hospital of Cumberland, Maryland

2. NUMBER OF PATIENTS INVOlMI.D: Thirty three (33)

3. NAM 13 OF PATIENTS: Not disclosed due to conddentiality

.t . SYNOPSl$ OF ILMEllEA), Ell ARTICLE:

• Entire anicle written about Sacred Heart Hospital addressed entities other than Sacred Heort Hospital.

• The article failed to report that all patients were diagnosed as inndnaRy ill plier to the imtiation of therapy treatments.

Panents' identit.ies are never disclosed to outside agencies and are kept in strict confidence.

Under advisement by the Attorney General's Of0cc of the State of Maryland, the Maryland Department of the Environment (MDE) drew up a Consent Agreement that was agreed to and signed by the attorney representing Sacred Hean llospital, MDE's Assistant Attorney General, Neil Quinter, and the Radiological Health Program's Admmistrator. Roland Fletcher.

5. INFORMATJON KNOWN BY THE STATE PRIOR TO PUBLICATION:

Complete investigation was conducted by staff members of the RHp.

6. NEW INFORM ATION FROM TIIE 11AEDEM,ER ARTICLE:

None.

• tso ;i *93

. atas r rest PAtilOLcGIC AL HEALTH FAGE.003 ,

a c

7 INFOlWATION GATIIER SINCE PUllLICATION:

None.

8. PATIENT FOLli)W UP:

According to hospital information, all patients treated during the 1987 88 incident time frame are deceased.

9. STATE ENFORCEMENT ACTION:

• Consent Agreement signed by attorneys representing Sacred }{eart llospital and MDE.

• Civil Penalty was invoked against Sacred Heart Hospital tota!!ing $15.000.00 and 52.000.00 reimbursement fee. Settlement was for $9.500.00.

10. 1 ICENSEI'. IllSTORY:

An earlier therapeutic misadministration occurred at Sacred Heart llospital during the period of August 946, .1988. Dr. Cynthia Brown, radiotherapist, was responsible for the treatment program in this case as she was during the misadministrations of thi11y-threc (33) patients. This case involved radiation doses to the y_mns area of the skull.

CET:dpn ,

ie TOTAL. PAGE.0_03 i* - --

, .14 Fi l - 19.L - ON 7 F Kt 1 Fi<D FGLTH IWH:H IO 91?O1!O C O2 P.02

• • si:i3orcernsmo D:ps'in*Snt cf NOTHb $0rvic08 Memorandum otta  : Janaary 21, 1993 to .

Jim Itfera State /grwreats P2tgrart Offloo of State Prtgrams U. S. Na:Imr Rcquintory Cammirmicri Washirgton, D.C. 20555 teom -

Fadiolcgic Health Brant 001 N. 7th Stnet P.O. B::rX 942732 Sacravato, CA 94234-7320 suw.ci _ Agetria for Otmaire. ion's Briefirg Janaary 29, 1993.

Su:retary of outline ocucrirg mtarial gathertd bf California's Radiation Cbntrol cornunire the ElaiJnalE articles:

Tacility Na:ae: Alta Daten Ikepital, Oaklard, CA, atd Went Cbut Can:er Tcurrbtion, San Frarcisco.

Patient: Dwight Golstein Article Syn:pcin: Patient died follovirg a therapeutic treatzent that was dcuble the doce prescribed.

Informtion the State Ibd: Prior to this article, the State Prtgram knw that the patient had died follevirn hin treatreat. .

Ncv Informtion: 'Ihe stato fcun3 cut duriay a prelimimry invcatigation that the patient was treated by a Cb60 teletherapy mchine ard an ?.rror war.

r.ndo by the consultant Hodical Ihynicist that caused a dcubliry of the dose delivend. It rue appears that the hecpital tried to cover the ewat's det.tils.

Patient Follo wp: A copy of the p3ticat's death certificate will be obtained.

Enforce: rat acticn: Tendirg ocepletion of assist investigation by lac, special investigator.

ya1-21-199 CG: ~i. FFtt i F@ HEi4.TH IW4):H TO CI30!!O4ZO2 P.CC j

-i

.. I Jim Myen: I ri N70 2 Jarraary 21,-1993 Licenm itictory: AuthorJzo:t to use talethorapy b/ /aneixt:ent # [s4 EQ Rte WAS exch31YJed April 5 , 1990.

I v. d Dorald E. Dann, Chief Enfortamrdit ard Cbapliance 1

TOTAL P.CC

0 Date and Place June 27, 1988; The Fairfax Hospital, falls Church, Virginia.

F Nature and Probable Consecuences - A patient was administered 2.7 millicuries of FIM MIDG rather than the intended dose of 500 microcuries of 1-131 MIBC.

1-133 MIBG is currently an Investigational New Drug and is used in a relatively new and rarely ordered diagnostic study performed at the hospital. Prior to the administration, the technologist involved, who was Unfamiliar with the correct amount to administer, checked both the literature which accompanied the shipment and the department's procedure manual. However, even though the correct dose was listed in the procedure manual, the technologist missed it and assumed that the entire vial of 2.7 millicuries was to be administered.

The misedministration tesulted in an estimated adrenal medullac dose of 268.4 rads, as calcuieted in accordance with literature supplied by the linited States food and Drug Administration. The thyroid burden should be negligible because the thyroid had been blocked with Lugols prior to the administration of the 1-131 MIDC, es prescribed in the protocol.

T hr- licensee stated the patient exhibited no adverse health cf fetts.

Cause or Causes - 1he cause is attributed to the technologist's error in overloo6ing the proper dosage as listed in the department's procedure manual.

Action la6 en to Prevent Recurrence Licensee The technologist was adnionished and retrained.

NRC - NRC Region 11 telephoned the hospital f or additional details on the E ident. The incident will be reviewed during the next NRC inspection at the hospital.

This item is considered closed for the purposes of this report.

glU?EG-G&?O L/M //j N'O. 8 AGREEMENT STATE LICENSEES tTWy Sy1'. /9CS Procedures have been developed for the Agreement States to screen unscheduled incidents or events using the same criteria as the NRC (see Appendix A) and report the events to the NRC for inclusion in this report, During the third calendar quarter of 1988, an Agreement State (Texas) reported the following abnorrnal occurrence to the NRC; A508-3 Medical Diagnostic Misadministration Appendi> A (see the general criterion) of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.

Date and Place

• May 17, 1988; West Houston Medical Center, Houston, Texas.

3

, . . ..s . s , . .. w _ _.au '

vrTrw rfr.m v ~ Y p. cos '

l r Nature and Probable Consequences - A patient was scheduled to be administered 30 microcuries of iodine-33) in capsule form for a diagnostic scan of her thy-roid. Instead she was administered 30 millicuries of iodine-131 in Capsule f u rn' . This resulted in an estimated dose to the thyroid of over 30,000 rads; such a dose would be expected to destroy the thyroid's function. The event was investigated by the Texas Department of Health, Bureau of Radiation Control (the " Agency").

After the patient's doctor ordered a diagnostic thyroid scan, the technologist mistakenly ordered a dose of 30 millicuries of iodine-131 on Sunday May 15, leaving the order on an answering machine. The pharmacist on duty the next day took the order but could not fill it because therapy doses are ordered from the manufacturer individually. He called the technologist to explain, and she agreed to postpone until the next day, May 17. When the dose arrived, she placed it in the dose calibrator and was perplexed by the high count rate she obtained, but administered the dose and told the patient to come back the next morning for her scan, lhe technologist mentioned the high count rate to the doctor, who apparently didn't get enough information to realize the potential problem and told her the count rate was relative.

On Monday May 16 she had ordered 30 mil 11 curie doses for two other patients to be administcred on May 10 and was informed it was too late to change the delivery but that there would still be 27.5 millicuries (quantity reduction due to racioactive decay) on the 19th, when the dose was to be administered.

When she checked with the doctor, informing him of the 27.5 millicurie dose, br corrected her saying she ineant microcuries. She still didn't realize her rn i s t a k e . Later, on the evening of May 17th, she ordered a 30-microcurle dose enc wat told it could be delivered right away. She asked why she had to wait for the others and was reminded they had been 30 millicuries. She then sealized her mistute and notified another physician on the hospital staff, who after consulting with the patient's physician, called the patient back to the hospital and administered a bloc >ing agent about 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> after the original dose was adn.i n i s t e r ed However, the blocking agent was felt to have little effect.

The hospital's estimate of the dose to the thyroid was 30,000 rads. The .

Agency's calculations indicated a thyroid dude of appror.imetely 34,000 rads. .

lhe hospital is perf ortring follow-up examinations of the patient. No prognosis foi the patient was evailable at the time of the Agency's report to the NRC.

Cause or Causes - The Agency's investigation indicated several Contributing f actors to t he misadministration. 1he hospital performs relatively few thyroid scans and they are all nerformed using microcurie quantities of iodine. Scans using other radionuclioes require millicurie quantities.

The technologist placing the order was not as experienced as the technologist who normally performed the scans. She had already performed several scans using millicurie quantities of other radionuclides and when the thyroid scan was ordered, went to her procedures manual for the quantity to be ordered.

When she placed the order, she apparently didn't realize she was saying milli-l curies and continued to confuse mil 11 curies and microcuries until after the 09se was administered.

4 i

vrn'F . ap., vn lass; 0:u j.

I Actions laken to Prevent Recurrence

.ticensee - The licensee is rewriting its prt tocol f or nuclear medicine scans to list each procedure with the activity and form of the material to be used. in addition, the licensee is instructing any firm supplying therapy doses of radio-pharmaceuticals that they are to be prepared only when the order is accompanied by a written prescription signed by the physician user authorizing the procedure or verbal, personal authorization is obtained by the pharmacist from the physician-user.

Agencv - At the time of the Agency's report to the NRC, the Agency was still reviewing the incioent to determine the appropriate enforcement action.

This item is considered closed for the purposes of this report.

A R A A A A A A e

5

4 +

Enclosure 4 I

estnist a ctesst utreun STAT 1 Of WAiHINGTON DEPARTMENT Of HEALTH-DIYl5lON Ot RADIATION PROttCTION Arnkstikt Center, stdg. 5

• f.O. 00s 47817

• Ofrmph WanMngton 98504 7827 .

January 15, 1993 Mr. Vandy Miller Assistant Director for State Agreements. Program

-U.S. Nuclear Regulatory Commission Office of coverrvnental & Public Affairs Mail Stop: V F-3-D-2 3 Vashington,,D.C. 20555 Dear Mr. 1 This is in responsn to your request for background information on radiation overexposures and/or statements contained in the Cleveland " Plain . Dealer" Newspaper seiies. There are three. references in the article ~to the state of- .

Washington. The first is a quote by our X-Ray Program Manager;-reference to.two -

incidents involving a Therac 25 Linear Accelerator in Yakima, Washington; and last a ref erence to a Riverside Hospital patient whose home is currently in this state.

The X-Ray Program'Hanager is quoted in the December 12, 1992 issue of the " Plain Dealer" He notes that "X-rays just haven't been given the rigorous regulation -

that 1sotoper have gotten". This statement was mado to the rpporters.for.the

" Plain Dealer

• sevetal months ago.in response to their inquirlos-regarding-the two incidents occurring in Yakima Washington. Even'though_ve believe. greater-control over therapy machines is warranted, it is highly likely that'in_these '

incident s , ne inspec tor or _ f acility staf f could have, in the routine discharge

- of their duties. discovered the flaw in the computer sof tware which lead to these'- -

incidents. It is also possible that a tougher standard would set 11 not have prevented these incidents.

1 Nationally, there were a number of incidents involving the Therac '25 during the-1986 and early 1987 timef rame, including the two in Yakinn e These were the basis-for action by the Food and Drug Administration,' CDRH requesting the manufacturer to notify all users to discontinue use _until corrective actions were approved and implemented. The 1987.Yakima incident was reported and investigated immediately by the state of Washington. Ultimately, it was attributed to a combination of software, heidware and operator errors. The direct cause of the ptoblem was a-mismatch within the . machine between carget position and recognition of beam condition. In retrospect, the earlier incident was probably also attributable; li to a Therac 2$ rnalfunction, but this went undetected until the time of the aecond :

incident beenuse the resulting reddening of the -patient's ' skin was originally--

thought to be a rash. (see page 98 in the " Proceedings of the'19th Annual i --

Conference on Radiation Control" 4 CRCPD, where we reported the results.of our investigations.)

s.ea l

\<

-m - - -

LilbIU3utc 4 Page Two Mr. Vandy Miller The final reference to the state of Washington is in association with a patient treated at the Riverside Hospital and only incidentally lives in the state of Washington. Any information regarding this overexposura and follow up should be referred to the appropriate regulatory agency for the Riverside Hospital.

If you have any other additional questions about these incidents, please let me know.

Since ly,

.R. Stron , Director Division f Radiation Protection TCF:amv S

e

l Enclosure 5 Annual Training Budget for Agreement State Personnel

isRC TRAINING BUDGET FOR STATES THOUSAND OF DOLLARS __

1000-- 816 815 765 ,

800~ 695 - 7 522 53 482 600- ,

3 l 3 81 ky' 350  ; f5 j22 400 - '

y 188 fids 1;

l sg; 187 200- ..

0 'E ." ' '

i' <

?' lY 'O 1989 1990 1991 1992 1987 1988 FISCAL YEAR M Dollar Amount 63 St. Employs. Trained 1

g 4

?

Enclosure 6 Escalated Enforcement Data for 1989 - 1991 and Enforcement and Investigation Data for- ,

Agreement States a w _

no o ~ m $

~

. NRC MATERIALS LICENSEE' ESCALATED ENFORCEMENT DATA: 1989-91 j 1989 BASIS FOR ESCALATED ACTION -

Types Total Misadmin- Over-

• nage- Loss of Willful . Other Escalated istration exposure Control ness cases ce xdown 0 2 0 1 Medical 4 1 1 ,

Broad-Community 14 1 0 10 0 2 1-Hospitals Private 10 0 1 7 1 0 2 Practice /

Clinics Telether, 5 0 0 3 0 0 2 Other 7 13 7 7 7 37 N/A Materials Licenses

! TOTAL 70 (33)' 2 (2) 8 (1) 34 (21) 10 (3) 9 .(2) 13-(6)

=_

L se.

^w-1990 BASIS FOR ESCALATED ACTION Types Total Misadmin- Over- Manage- Loss of Will ful- O er Escalated istration exposure ment Control ness Cases Breakdown 5 5 0 1 l Medical 13 1 1 Broad L

Community 22 3 0 12 1 8 1 l

l Hospitals 0 2 3 0 0 Private 2 0 Practice /

Clinics Telether, 6 5 0 2 0 0 0 l

13 9 10 12 5 l Other 45 N/A Materials Licenses TOTAL 88 (43) 9 (9) 14 (1) 30 (21) 16 (6) 20 (8) 7 (2)

1991 BASIS FOR ESCALATED ACTION ,

Types Total Misadmin- Over- Manage- Loss of Willful- Other Escalated istration exposure ment Control ness Cases Breakdown Medical 9 1 0 4 1 1 2 Broad Community 12 2 0 6 1 3 0 Hospitals Private 3 0 0 1 0 2 0 Practice /

Clinics Telether. 1 0 0 1 0 0 0 Other 39 N/A 4 9 7 10 10 Materials Licenses

-=

TOTA! 64 (25) 3 (3) 4 (0) 21 (12) 9 (2) 16 (6) 12 (2) n Numbers in parentheses refer to total medical cases, i

l l

l

Enclosure 6 AGREEMENT STATE TOTALS FOR 1989 - 1991 INCIDENT REPORTING PROGRAM Review Cycle Licensees Incidents On-site Incidents reported to inspections reported State of incidents to NRC 87 - 89 _13802 1475 878 610-89 - 91 14555 1927 1251 793 _

I INVESTIGATIONS OF ALLEGATIONS Review Allegations Allegations RESULTS (investigations Cycle investigated ending with enforcement action) 87 - 89 126 114 15 89 - 91 123 123 32 ENFORCEMENT PROGRAM Review Cycle Civil Impoundments Criminal Enforcement Orders penalty penalty conference issued 87 - 89 112 20 1 51 68 89 - 91 103 18 0 126 93 1

A number of Agreement States do not distinguish between incidents and allegations for investigation or record keeping purposes. The data from these states is included under

" incidents" only.

Enclosure 7 Synopses of OI investigation of Hisadministration Cases m

k . . . _..._...___.._..mm_ ._*. _.__a-

December 23, 1992 MEMORANDUM FOR: William D. Hutchison Assistant to the Director Office of Investigations '

FROM: Betsy S. Barber Office of Investigations

SUBJECT:

SYNOPSES FOR MISADMINISTRATION CASES WHICH WERE SUBSTANTIATED;-BREAXDOWNS BY YEAR CLOSED AND PROGRAM CODE Attached at Tab A per your request are synopses for nine misadministration cases which were substantiated either by OI or other independent investigators. Eight of the nine cases were substantiated by 01. The Ellis Fischel State Cancer Center (EFSCC) case was substantiated by an investigation by the EFSCC Radiation Safety Committee; however, 01 did not conduct a full-scale investigation thereaf'er. The following is a list of those cases:

1-84-034 Thomas Jefferson Univ. Hospital 1-85-014 Mercy Hospital 1-92-009 Rhoda h. Cobin, M.D.

2-87-011 St. Mary's Hospital 2-91-013 U.S. Veterans Affairs Medical Center 3-85-002 Bloomington Hospital 3-87-003 Edward Hines, Jr., VA Medical Center-3-90-005 Ellis Fischel State Cancer Center l 3-91-004 Copley Hospital The chart at Tab B breaks down the 20 misadministration cases by year closed, beginning in 1982 (the year of 01's inception). The same misadministration.

cases broken down by program code are as follows:

Program Code 02110/ Medical Institution Broad - 5 cases Program Code 02120/ Medical Institution Limited - 10 cases Program Code 02200/ Medical Private Practice Limited - 2 cases Program Code 02300/ Teletherapy - 3 cases A listing of the 20 misadministration cases is attached at Tab C. A comparison of this list of misadministration cases was made with the more extensive li:t prepared by J. Hunt of all cases involving hospitals, clinics, or their employees in response to a FOIA request (see memorandum dated 3/11/92 to Dick Lavins, ADM). It should be noted that the reason-that the FOIA-response list is longer than the above listing is that many of the cases i

involved violaticns other than misadministrations.

Attachments: Distribution: s/f RPT (01 Miscellaneous)

As stated r/f BSB r/f JHunt a . h>

12/23/92

.. , .< 4 =

,1

Title:

- THOMAS JEFFERSON UNIVERSITY HOSPITAL: .

ALLEGED MANAGEMENT CONCEALMENT OF MEDICAL M!$ ADMIN!STRAT!0N'0F -

RA010 PHARMACEUTICALS Licensee: Case haber: 1.M.034 .

Thomas Jefferson University Report Date: May 21'.11986 Philadelphia, Pennsylvania 19107 Control Office: 01:RI Docket No.: 30-2941 Status: CLOSED' SYNOPS!$-

This investigation was initiate'd based upon an allegation from a Nuclear Medicine Technologist at Thomas Jeffersen University Hospital. The Technolo-gist alleged that four or five diagnostic misadministrations had occurred at Thomas Jefferson within the past six months and the Department Head had:not:

reported the matters to the Radiation Safety Officer (R50) or the NRC.

The 01 investigation revealed that three diagnostic sisadministrations-had --

occurred at Thomas-Jefferson University Hospital-in May and-October 1982 and; in December 1983. These three misadministrations has net Caen reported.toithe NRC,.The investigation revealed, however, that the three incidents'had been reportee to the RSO shortly after the occurrences and that it had been his decision, in consultation with the Nuclear Medicine Department Head, not to report the matters-to the NRC.

The RSO and the Nuclear Medicine ~0epartment Head stated that the three incidents--

had net been reported to-the NRC because.-at-the-time, they had not considered them to be'misadministrations. In two of the instances' the Department Head:

contacted the referring physicians who subsequently requested scans be performed.

Thus, the'R50 and the Department Head felt that since some diagnostic.value could be gained even though the wrong patient or the wrong pharmaceutica 1 shad been injected, the matters did not. constitute misadministrations. ;In the remaining case, the R50 and the Department Head had not.:at the time, thought -

that it was a misadministration since the proper radiopharmaceutical had been injected even though the necessary preparatory injection had been omitted.

Beth the R50 and the Nuclear Medicine Department Head now acknowledge that they were wrong and that these matters should have been reported to the NRC as' misaccinistrations.

None of the Nuclear Medicine Technologists' involved in the misadministrations-said that they were prohibited from contacting the Radiation Safety Office or-the hRC. The Technologists also stated that they had not-been told to " cover up" misadministrations. In fact, written reports had been prepared concerning each of the misadministrations.

N disciplinary action was taken against the alleger for reporting these matters.to the NRC. Subsequent to this allegation. she voluntarily lef t her employment at Thomas Jefferson University Hospital.

MERCY 'ADSPITAL, WILKC5-SAARE, PENNSYLVANIAF

~

- ALLEGED FAILURE TO REP 0kT A DIAENDSTIC' MISADMINISTRATION A$ k! QUIRED BY 10 CFR PART 35 Licensee: Case Nurter: 11-85-014 Mercy Hospital Report Date:

25 Church Street 450 vember 12, 1985-P. 0._ Box 658 Control Office: 01:RI Wilkes-Barre, PA 18765 Status: CLOSED Docket No.: 030 02971 SYNDPSIS This investigation was initiated based upon a request from the'ReginntT Adeinistrator, Region I, that an investigation be conducted into an .

alleged failure on the part of the Mercy Hospital. Wilkes-Barre.

Pennsylvania (licensee), to report a diagnostic misadministration in violation of 10 CFR 35.

On May 8,1985. Region I received an anonymous telephone call alleging-that the Mercy Hospital'st Nuclear Medicine Chief Technician-injecte' 'he

. wrong patient with a radiopharmaceutical on May.8. 1985. The Code e.

2 Federal Regulations Title 10 of Part 35.43 requires the licensee to- .

report diagnostic misadministrations, in writing. *within 10 days after :

the end of-the calender querter," July 10. 1985.- - The Code further L recuires written notification.of the misadministration to the patients'

" referring physician." No report of a diagnostic misadministration was

-received by the NRC from the licensee on or before Ju -10,1985, and- a-Regien 1 inspection team was sent to the hospital on J ly <17,1985.. The inspectior, did not confim nor. disprove the anonymous allegation. During the hRC inspection the. Chief Nuclear Medicine Technician told the NRC- -

Inspettors that the-hospital-had cot had any misadministrations sinceL L June 1984, and the incident had been reported to _the NRC.

L This investigation detemined that a diagnostic misadministration did I

occur at. Mercy Hospital on May 8,1985, and the misedministration was not reported .to either the NRC or the patient's referring physician as required by 10 CFR 35.43. Interviews established that-the misadmini-stration was mistakenly administered to the patient by the Chief kuclear Medicine Technician and reported by her to the hospital's Medical Director

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of Radiology, who is also the Hospital' Radiation Safety Officer (R50).-

In a -sworn statement, the-RSO admitted that the failure to report the

i. misadministration was a deliberate.act on his part done with the knowledge that the incident required NRC notification.-

L l This investigation further deterzined that the Chief Nuclear Medicine j Technician deliberately lied to NRC. Inspectors during an inspection on July _17, 1985. In a sworn statement, the Chief Nuclear Medicine Technician-testified that she lied to the NRC Inspectors' when they asked her if any -

mister.inistration had occurred since June-1984, because she was told net.

to report the May B 1985, misedministration by the Medical Director of Radiology /RSO.

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Title:

RHODA H. COBIN, M.D.:

ALLEGED MISADMINISTRATION AND FALSE INFORMATION To THE NRC IN A LICENSE RENEWAL APPLICATION Licensee: Case' Number.* 1-92-009 Rhoda H. COBIN, M.D. Report Deto: October . 3 0, ' 1992 44 Godwin Avenue Midland Park, New. Jersey 07432 Control _ Office CI RI Docket No.: 030-14950 Status: CIASED SYNOPSIS On April 8, 1992, the Regional Administrator (RA), II.S. Nuclear-Regulatory Commission - (NRC), Region 1, requested that the Office-of Investigations - (OI) determine if a licensee (a. actice.1 doctor) deliberately violated NRC regulations involving the use of radiopharmaceuticals and deliberately misled the NRC in a May:22, 1990, letter supporting a license-renewal application dated July 3,-1989.- The apparent violations ~were identified-during a February 7, 1992, routine, unanhounced NRC safety-inspection..

The OI . investigation concluded that' the doctor deliberately failed to. either repair or replace her dose calibrator when the -

constancy error exceeded 10 percent. However,-there is insofficient evidence to conclude that the~ doctor knowingly misadministered doses to any: of her patiente.

The OI investigation also determined.that, at times, between.1987 and the February 7,1992, NRC inspection, the doctor. deliberately.

violated the NRC regulation requiring her to have both a -high J -

range;and low range survey instrument at her facility. However, there is insufficient evidence to. conclude that the-doctor deliberately misled the NRC with her assertions about the instruments in the May 22, 1990, letter.

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REPORT OF.INVESTIGAT!ON .2

Title:

ST. MARY'S HOSPITAL:

WILLFUL MISADMINISTRAT!0N OF WUCLEAR MEDICINE Licensee: -

Case No. 2-87-011-St. Mary's Hospital Report Date:

P. O. Box 620- Nay 25 ~1988' Norton. Virginia Control- Office: : 01:RI!

Docket No.: 030-20156 ~

Status: - CLO5tD - -

SYNDPS!$ ,

This investigation was initiated upon the request of the U.S.' Nuclear Regulatoi ry Com ission (NRC), Region II Regional Administrator to-resolve an-allegation-that a. nuclear medical technologist employed at St. Mary's Hospital-(SMH). .. ";

Norton, Virginia, had-intentionally administered a dose of diagnostic radio-active isotepe in excess of the prescribed amount. It was elleged that the-employee administered excessive doses on two occasions on March 12,1987,.in

-apparert violation of the requirements of ;10 CFR 30.51:and Muclear Regulatory '

t Guide 10.8 Appendix G as incorporate.d into'the-SMH license.

j' The alleger in this matter received information that a nuclear medical-technologist at SMH was riisadministering radiopharmaceuticals in the process of. '

l conducting radicimage scans. Upon receipt of this information the= 5MH Raciation Safety Officer (R$0) conducted a Radiation Safety Comittee (RSC)_

meeting where: dese limitations were specifically. discussed.c on the following:

day, the R50 reviewed two scans csnducted by the nuclear medical technologist-and calculated extensive-overdoses. Three co-workers also gave evidence;that the nuclear medical technologist had overdosed patients;on previous occasions.

One of the co-workers confronted the nuclear medical technologist on onC C occasion and was told that excessive doses are routinely ~edministered by.-

E . nuclear medical technologists to speed up the scan procedure. Another former 4

co worker who trainec under the nuclear medical technologist testified .that she ~

L was taught to routinely administer an excessive dose of isotope but to record' e the correct prescribed dose on the isotope contrrl log.

In a swern statewent to the NRC, the mucher medical technologist attiitted that he did. in certain instances, inject a dosc of isotope in excess of the -

prescribed amount. -The nuclear medical: technologist asserted that he had the pereission of radiologists.st his previous two p aces of employment to use his-i- own judgment as to when a larger dese of isotope was required for an acceptable r image. Investigation ~ revealed that none of the radiologists had: discussed. nor.-

! would they have permitted such a practice. The nuclear medica 11 technologist:

B said in his sworn statement it was his practice to use a larger dese of isotope E

when the patient was overweight in order to overcome the effects of the-fat-tissue. Several radiologists refuted this: statement and said there was_no medical basis for exceeding the prescribed dose of radioisotope in.any case.

None-of the nuclear medical technologist's former co workers had ever heard of . o

' such a practice nor had he tver discussed such an issue with them. The general consensus was that the larger dese: served only to speed up the scan process for the convenience of the nuc ear medical:technologistLand tsat it was not a common or acceptable practice.

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Case No. 2-87-011 (cont) l Although the nuclear medical technologist adr.itted to giving excessive doses in I certain cases. it was observed that he never recorded an amount higher than the l prescribed dose. At one point in his sworn statement, the nuclear medical technclogist said he recorded the actual dose administered. At another point in the interview, he said he rounded off the administered dose to the nearest whole number and then contradicted himself again later when he said he wrote down the intended dose on th( log.

Based upon information obtained during the course of this investigation, it was determined that the nuclear pedical technologist made a practice of risseministering diagnostic radiopharmaceuticals and concealed that practice by entering false data on required records. The nuclear medical technologist further tried to conceal his wrongdoing by intentionally making false statements to the NRC which were later refuted by witnesses. Prompt action was taken by the SMH RSO in reporting this violation when she discovered the practice and there does not appear to be any wrongdoing er prior knowledge on the part of the responsible licensee management.

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1 T1 tic: te.8. TNTER&BS AFFRERS MEDISEL SENTER ALL90ED EIS&BEINISTR&TI M W WDCLBh3 ENDICINR .,

Liosasse Case No. s . 3-91-913R 5.8. Teterans &ffaire Sepert Date Sept. 14, 1992 Medisal center-700 s. 19th street tiraingham, Alabama 38233 Seetrol Offleel ~ 914122:

Doebet No.B GSD-91264 Statas ERASED ..

STuopSIs on cetober 9, 1991, the Regional Administrator, 9.8. Buclear Regulatory caenission (ERC),-tegion II, roguested that the Offles~

of Investigations (02) taitiate an investigattom regarding a possible misadaisistration of radiopharmaceuticale (RPs) by a' auclear medical technologist (technologist) at the Veterans Affaire-Medical center (YnNC), Birmingham, &L.:-The'or was also asked ~to-determine if the technologist failed te~ measure.RP doses-and whether the- Radiation safety Officer' (Rso) properly .

l- investigated the sharges Then they were brought to his-attention.-

Rased en the evidemos developed during the investigation, which tacluded the results of a polygraph esanimaties, it was- ~

determined-that the technologist deliberately injected eseessive i '

doses of RP into several patiente durlag the period July 32-26,-

1ssi. It could not be deternised which specific patient (s) recurred the miss&aimistraties-due to a failure sa the assistaat supervisor to reopend to the allegation la a timely part of ani manner. The investigation by 01 determined that the licensee failed to properly tavestigate.the alleged miendainistration-and.

that the-Rao deliberately esseetled the incident from the NRC and

[_ VAMc Radiation safety ceamittee (Esc)..

i The-evidence also supports.the allegaties that the medical technologist failed to measure the RP deses during the weekiin  ;

question as required. Bewever,-there is tasuffleient evidense to.- 1 substantiate'that any specifie dose was astLacasured.- ij l

p The evidence eenfirmed'that the teshaslogist failed to record' .

approximately 100 patient deses trea' September 1989 through July j issa. The missing patient deses were identitled on a regular- q basis by the technologist's superviser and recorded la a pereenal:  ?

file which was met made available to the ERC. The superviser and-  !

the' chairman of the Esc were both aware that a large number.et; patisats were listed 'ia the pe=esaal' filer bewever,- they did not correct the patient dose Sogn, mer'did~they make the peroomal file available for inspection.~ sy withholding this ille, they- 2l deliberately failed to provide the ERC with semplete and soeurate i

l-information since they were aware of the technologist's failure to hoop required records. Seesuse the supervisers failed ta=take-oorrective action in the faea of a known and seatinuing violation en the part of the techaelogist, the 11eensee failed to supervloe

'the. technologist and'is,~therefore, also reopensible for his' viclettens.-

The.TANC R30 deliberately esseealed the alleged misadministration by reporting the matter to the SIRC and the TnNC'RSC as a record-keeping error. ~The Eso deliberately avoided as investigation into an' alleged misadministraties and, therefore, violated an atRC regulatlea requiring him to de me.- '

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Title:

DLOOMINGiDM HOSPITAL (1) ALLEGED WILLFUL FAILURE TO REPORT DIAGNOSTIC MI5 ADMINISTRATION 5; AhD (2) ALLEGED WILLFLIL 1HPEDIMENT TO MRC INSPECTOR $ THROUGH MTERI AL FALSE STATEMENTS AND THROUGH THE WITNHOLDING Of RECORDS REQUESTED BY NRC INSPECTORS Licensee: Cese Number: 4-55-002 Blood ngton Hospital Report Date: Nrti 28,1986 Dioccington, indiana control Office: 01:R111 Docket No. 030 01644 Status: CLOSED SYNDPSIS On December 31, 1984 NRC Region 111 (Rl!!) requested that an investigation be initiated regarding the results of an October 1984 NRC RIII inspection of the Bloomington Hospital Nuclear Medicine De urteent. Bloomington Indiana. The inspection was prompted by allegations tist the Bloomington Hospital Radiation Ssfety Officer (R50) had willfully disregarded NRC reporting nquirements regarding diagnostic misadministrations. Further allegations were rectived by NRC Rlll that the Bloomington Hospital RSO had willfully impeded the NRC RIII inspection by directing Bloonington Hospital staff technologists to mislead the NRC inspectors. It was further alleged that the Bloomington Hospital R50 willfully impeded the NRC inspectors by failing to provide for review certain nuclear scans reevested by the NRC inspectors, which were. in fact, available at the 142 of the tryection activity.

The Office of Investigations (01) investigation revealed that four patients were risadministered between the dates of October 14. 1983, and August 3. 1964.

It was further revealed that the required MRC reports regarding the diagnostic misadministrations were not performed.

The investigation further nyealed that Bloomington Hospital's RS0 is an

, experienced r+ dical doctor, knowledgeable in the field of nuclear medicine and familiar with HRC reporting requirements. It was .iearned that appropriate reports regarding diagnostic misadministrations had been made prior to the questionedtimeperiod(October 14, 1983, to August 3,1984) and following the questioned time period. .

Regarding the allegations of the R50 tapeding the MRC inspectors during the October 1984 NRC RIII inspection, the following was revealed. The R$0 directed the Bloomingten Hospital staff technologists to respond to the NRC inspectors by denyir.g that unreported misadministrations had occurred. This action by the technologists would have corroborated the R50's false statements to the NRC inspectors denying unreported diagnostic misadministrations. One of the technologists responded to the NRC inspectors as directed by the R50.

'. Case No. 3-85-002 (ccat)

It was further revealed that the R$0 was observed, by a 81ocaington Hospital technolegist during the October 1084 inspection, removing nuclear scans from a patient's file and placing said film into the patient's x-ray file. The film bad been requested by the NRC inspectors for review. Regarding this particular patient, the RSO denied that a misadministration had occurred and was observed by the NRC inspectors altering the date on the patient's file free the date of the alleged risadministration to the date of the administration of the properly prescribed radiophamaceutical for which scans were provided. A subsequent search by Bloomington Hospital records personnel revealed the nuclear scans, which revealed the misadministrations, were found inside the patient's K-ray folder.

On a separate occasion, during the NRC RI!! Octdber 1984 inspection, the R50 was observed by a second technologist reviewing nuclear Scans from the file of another patient which had been requested by the NRC inspectors. The inspectors were subsequently infomed by the RSO that the requested film was unavailable.

However, a subsequent search by hospital personnel revealed the requested film was available for irnediate insNction by the NRC inspectors. The film, when reviewed against the referring physician's request: "evitaled evidence of a misadministration.

The RSO was also observed by a technologist altering a patient's history card during the NRC RIII inspection to reflect the administration of a radiopharma-ceutical which had not been prescribed by the patient's referring physician.

The personal history card, according to the hospital's records chief, is a key to the patient's file and reflects the referring physician's order. The cards are maintained by records personnel, not the medical staff, and ordinarily reflect only the referring physician's orders. The effect on the NRC inspector of altering the personal history cart!. was to provide legitimacy to the nuclear scans four.d to have been evidence of misadministrations. The NRC inspectors recognized the discrepancy on the patient's personal history card between the time of the October 1984 inspection and the subsequent requested 01 investigation.

In a November 1,1984, response to a NRC RI!! request for en investigation to be condacted by the President of Bloceington Hospital, one par +1cular patient's alleged misadministration was denied by the President, who referenced the patient's referring physician as justification for his findings. Subsequent investigation revealed that the patient's referring physician denied the statements attributed to him by the President and further supported the original allegation that a misadministration appeared to have occurred.

The R50, who initially had denied any unreported misadministrations to the NRC inspectors, acknowledged to NRC:01 Investigators that he was aware of the misadministrations and had not, for a variety of reasons, ytported to the NRC as required. The RSO denied any atteept to mislaad or impede the NRC inspectors, stating that the inspection was unexpected, stressful, and that he could not recall what was said during the inspection.

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Title:

towARD MINES,4R.. VtitRAMS ADMIR15TRATIOR SEDICAL tEhTER ALLEGED WILLFUL FAILURE TO REPORT DIAGNOSTIC R15AININISTRATIONS-AND ALLEGED WILLFUL ORTERIAL FALSE STATINENT5 License:; Case M rs- H 7-003 Edward Hines. Jr. Veterans esport Date:- thovember 4,1987 Administration Medical Center Nines,IL 60141 Control 9ff toes ,01:R111 Docket No. 030 01391 Status: CLOSED SYNOPS1$

On February 10. 1987, the Office of Investigation (01) Field Office.

Region 111 (R111), received a Request for Investigation TNe the Rl!! Acting Administrator. The request evolved from anonymous allegations that three unreported inisadministrations involving diagnostic redtopharmaceuticals ,

occurred at Edward Hines~. Or., Veterans Administration Medical Center (HMC) during the week of Augus 4-8, 1986. An MC Soard of

• Investigation (BI) concluded that only one sisadministration may have occurred and requested NRC assistance. Due to the conflicting stataments received during the NRC:RI!!'

inspection of this matter the case was referred to 01.

The first alleged Jingnostic misadmin11.tration involved the stainistration-of Technetium-99m diethylenetriaminepentaacetic (Tc.99m DTPA), a brain scanning agent, rather than the one intended. Technetium 99m medronate:

diphosphonate (Tc 99m MDP) a bone scanning agent'. Evidence revealed that the allegee risseministration was brought to the attention of the 9940 Section . f Chief of Clinical Nuclear Medicine (SCCm)-(4 physician Board-certified ini nuclear medicine) by the Acttng Chief Technologist'(ACT).- It was further :

revealed that af ter the SCCM became aware of the alleged misteninistration, 1 the SCCh*. claimed that he had changed 'the prescribed bone scan.to a brain scan. The SCCM then identified and represented the brain scan to the patient's referring physician as the originally prescribed bone scan, never indicating to the referring physician that the SCCM had at any time changed the original order or that a misadministration had occurred.

The second alleged diagnostic misattinistration involved the administration of a radiopharmaceutical._ ge111um-67 citrate. not regulated by the NRC, to tne wrong patient. Again. the alleged misadministration was arought to the -

attention of the 5tte by the ACT. After the LCCM was notified of the alleged misadministration, the SCCM obtained a Consult (an 994C physician's-order form for a diagnostic study) from an MC staff physician ordering a scan to val.idate the injection of the wrong patient. The staff physician had no knowledge that the patient had already been allegedly misadministered when he completed the requested Consult for the SCCM.

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Case No. 3-87-003 (cont)

}

The third alleged diagnostic misu6 ministration involved the shinistration of a radiopharanceutical (Tc-99m MDP) rather than the intended gallium-6'I citrate. This alleged miseeninistration was also brought to the attention of the $CCNM by the ACT. Following the third alleged mist $tinistration, the ACT also informed the MC Chief of Nuclear Medicine (CE) of the alleged misteinistrations and advised the CNM that reports had not yet been initiated, although the ACT-had previously reported the incidents to the

. $CCNM.

The SCCW directed a technologist to support the SCCm's explanation of the events regarding the alleged first miseministration when ty technologist was questioned by the CM. The technologist emitted that he had lied to the mC:B1 and to the R111 inspectors regarding the facts of the first alleged e.isadministration out of fear of contradicting the SCCm. Further evidence revealed that the Chief Technologist observed the SCCM remove and discard a key document relativt to the alleged first misseministration from the patient's nuclear medicine file just prior to the R!!! inspection.

During this investigation, evidence also nyeeled that several nuclear medicine staff members obstructed the 2C:81. One former staff member refused to testify to the HMC:BI; another staff member admitted concealing pertinent inforr.ation; and a third staff mond>er admittec' lying to the HMC:BI and to the RI!! inspectors.

The 01 investigation . identified evidence which allowed the NRC to conclude that three patients received diagnostic aisadministrations, two of which, though reportable, were not Mported to the NRC. It was established that the misahinistrations were brought to the timely attention of the SCCNM, who willfully f ailed to report the misadministrations as requimd by the NRC. It was also established that the SCCNM made asterial falso statements +

by denying that the misadministrations occurred; destroyed evidence of one of the misedt.inistrations by removing a key document from & huclear Dedicine file prior to the Rll! inspection; and impeded the NRC by directing a technologist te make false statements to the NRC. The SCCNN also attempted to influence the testimony of the ACT by suggesting that the ACT not recall pertinent facts Wnen questioned by the HMC:BI or the NRC.

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gr, 3-7 e.

a, litle:L ELL 15 FISCHEL STATE CANCER CtrTER:.-

FAILURE TO REPORT A MISADMINISTRATION Licensee:

Case thanbers 90-005t Ellis Fischel State Cancer Center Report Date: Febreary 1,.1991 '

210 Susiness Loop 70 West Columb1a Misscurt $5203 Control Offfce: 01:RI!!

Docket No.: 030-02274 STATUS: CLO$tD ItCTAILS OF 1RVt3TIGAT10N Turpne of Investination ,

~

1 mis-investigetion was initiated on March 16, 1990, at the request of the Nuclear Regulatory Comission (NRC) Regional Administrator.' Region 111'(Rl!!),

who alleged that Certain personnel at'E111s fischel State Cancer Center i (Ellis Fischel), Columbia, Missouri, had covered up a stsadministration that occurred in October 1987. The event was discovered by.the Itsensee during an audit of the Nuclear Medicine Department and was subsequently reported to the NRC as a niisadministration with a potential willful concealment of facts. The- j intent of the investigation was to determine whether the alleged cover up was -

the action of one or more persons and-if management had any direct involvement- ,

t in the concealment of the facts.-

Beckeround

• On September 12.1989. the NRC received documentation of a'11censee audit from Ellis Fischel indicating that a former staff member, Angel GARCIA. M.D.,- 1 had allegedly covered up a diagnostic misedministration on October 12, 1987.

On December 12, 1989, an announced MRC safety inspection was conducted at- d

,t Ellis Fischel-to review the circumstances surrounding the reported.

tnissderinistration and the alleged cover-up as reported. . GaryJEAR Senior Rediation Specialist,- R111, substantiated that a ptient'had inadvertently been given a misedministration (injection of Tc-99m oxidronate) and that the .

Head of Nuclear _ Medicine, Dr. GARCIA, apparently in en attempt to conceal this!

fact, subsequently issued a requisition for a bone scan. The event was

- reviewed by Ellis Fischel's Radiation Safety Conenittee, which subsequently '

concluded that not only did the misadministratton occur but that it was covered up by Dr. GARCIA.

Based on WRC's safety inspection and review, they_

concluded cover-up. thet there was no evidence of management complicity in the alleged i

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Case No. 3-90-005 (cont)

Closure Information The Office of Investigations (01) has conducted a prellatnery inquiry into the a11egation and has determined that although the case warrants further investigation into potential wrongdoing on the part of Dr. GARCIA, this case is being administratively closed by 01 due to the lack of investigative resources in accordance with Commission approved policy as_ prescribed in

$ECY-85-369. Furthermore, on Septeenber 26,1990, [111s Fischel requested terrination of their Itcense because their programs were being taken over by the University of Missoort. All future Itcense activities will come under the broad scope license of the University who will have primary regulatory and sefety oversight of the remaining Ellis Fischel personnel. Dr. LARCIA is no lon;er employed by Ellis Fischel and has last been known to be practicing medicine unrelated to nuclear activities in the State of Georgia.

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Title:

CDPLEY HOSPITAL:

ALLEGE 0 MATERI AL FALSE STATEMENTS IN THE REPORTING OF A DI AGNOSTIC MISADMINISTRATION AND RESPONEE TO A CONFIRKATORY ACTION !.f'IR Licensee: Case Ntsnber: 3-91-004 Copley Hospital Report Date: February 21, 1992 Washington Highway Morrisville, Vemont 05661 Control Office: 01:R11!

Docket ho.: 030-17125 Statuss CLOSED SYNOPSIS On March 29, 1991, the Office of Investigations received a Request for Investigation from the Regional Administrator, U.S. Nuclear Regulatory Comission (NRC), Region I, concerning a possible material false statement made in a Diagnostic Misadministration Report (DMR) dated August 14, 1990. The DMR was mailed to the NRC from Copley Hospital (CH), Washington Highway, Morrisville, Vermont, an NRC licensee. On June 19, 1991, the investigation was expanded to detemine if the licensee also provided false infomation to the NRC in an April 1, 1991, response to an NRC Confirmatory Action Letter (CAL) dated March 1, 1991.

This investigation determined that although the DMR was inaccurate, neither the technologist who prepared it nor the radiologist who signed it deliberately intended to deceive the NRC.

It was concluded, however, that the Radiation Safety Officer (R50), carelessly disregarded NRC regulatory requirements by failing to conduct an thorough investigation of the cause of the misadministration and accurately documenting and reporting the cause.

This investigation also substantiated that the CH April 1,1991, response to the NRC CAL was inaccurate. There was insufficient evidence, however, to conclude that the inaccuracies were known to be false and were deliberately reported f alsely .y either the RSO or other CH officials.

The investigation was to detemine if false statements were made to the misedministration report to the NRC or during the NRC inspection into the matter; if f alse statements were made, who was responsible and what was their intent; and whether the capsule that was administered to the patient was even measured at all prior to administration to the patient. In addition, O!

should also determine the level of management involvement if any wrongdoing is confirmed. It also requested that OI attempt to detemine if doses were administered to patients on other occasions without the required dose assay being perf omed.

e U.S. NUCLEAR REGULATORY C0tH15510N 0FFICE OF INVESTIGATIONS PERCENTAGE YEAR MISADMINISTRATIONS OF TOTAL CLOSED (NUMBER OF CASES) CASELOAD 1982 0 -

1983 0 -

1984 0 - l 1985 1 0.?4 1986 2 1.64 l 1987 2 2.25 i 1988 3 2.44 1 1989 1 0.93 ,

1990 0 -

l 1991 2 2.82 l 1992 (thru 10/31) 5 4.39 OPEN as of 10/31 4 2.53 TOTAL / PERCENTAGE 20 1.37 NUMBER SUBSTANTIATED 9 (45% of Cases)

TAB B PS5/5/12/23/92

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J2/22/32 0.I.BUCl2AlIEElf0ff00EISS10E OFFICI 0F 1mSTIEfl0I5 CASI MTA 13 0F 11/30/92 - ALL B G1015 -

EISDEll!Stufl01 CASIS E F200A! CaftG0H .

CASI10. FA;!L!ff OPDD C'4SD . ISSUD ItFBID ACfl0E &!JEAfl01

PIXu! COM C2110 8 UG10N 1 1-56034 TDEA5 RFFI!50151m5112/11/84 05/21/86 05/21/86 /- / EIAGIEUT COICIA! Elf 0F EDICAL IISCEll!Stufl0 '

0FID10FillEtyTICALS F9204!i 71NFS EVAR A, W ! m 3! M 11/30/92 // // // ELIGD E151M11157117101 AD FALSITICat10f 0F' E00D5

• U G!05 2 2-51-0:3 1. A. E:!CE Cii. 10/10/31 09/14/92 S 10/09/32 10/10/92 m ALLIGID tISDE!IIS!ui106 Of IXLui E!CM-

• !!313 3

'3-85;!( W;iES:n Of CIN:lFNA!! 12/22/2610/27/8B 11/10/58 // VILLE Fl!LUU 70 ID0!! A THELPICIC E!S& Mil!S!!At!0I-3!?003  !!Fi! VA D 5iltAL 02/18/8711/04/87 11/13/9711/13/27COI IlLL E FAILUEI TO H P0tt Dil30! TIC EISLMIIIStilt!0IS AD IILLE ETEln FESI:

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• M a!0N 1 bibO14 Ell *T E;HI!E 07/23/2511/12/E5 01/31/8601/31/86VIC Emlit 7ESI mitEHT MCIIIIIG VIUPO!!D HISAMIIIST1H105-1 $2 00 EEE ISHE D5!!!AL 08/11/S211/13/32 // // ALLI3D XISDElliSfufl0E AfD U OmID05UH s U"!05 2 2-87-011 57. E !!'S D 5?ITAI 06/24/6705/26/88 07/01/t!07/01/88COI IISAMIIISflH1010F f%LIII HDICIII-i U 13 3 3-!5002 E002: nit 0E E5FlfE 01/03/8504/22/16 06/09/I606/09/t!COE flLLFUL FAILUt! TO HP0ti IISAMII!STU!!0i! E VILLE IMIDIGIT THU ETE!E FALSI Sili!ERS AE ilfEEDlla IIF0 3-6b010 C!i0 C. I!? E!. D5PITE 08/12/88 06/22/89 0 07/10/89 // Fil!ERI TO IIP 0tt X150E11!m411015 G"-H 0!!  !!IE!! L"!BIA5 D5?ITE 10/20/5812/0!/85112/05/83 // VILLC FAI!EH 70 FOLIhv Pl%DTd TAB C

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' 12/22/52 U.S. 50 M I! M 0ff M SSIOf OTTICI0FIMSTIGit!085 -

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Enclosure:

8- ,

o.  :

Statistics on Adequacy ~and Compatibility '

of Agreement State Programs ..

m d_ y Adequacy and Compatibility of Agreement State Programs NRC's criteria for Agreements with States under Section 274 of the Atomic Energy Act of 1954, as amended, detail the principal programmatic elements -of adequacy and ccmpatibility. The initial criteria was published in the Federal Register in 1981 and was most recently amended in 1992. The Office of State Programs provides oversight of.the Agreement-States and has procedures for evaluating them for adequacy and compatibility. To assure continuing adequacy and compatibility of Agreement State Regulatory Programs, on-site, routine reviews and visits are conducted at appropriate intervals. A routine review is scheduled approximately every two years with each Agreement State and a visit scheduled the year opposite the review. For each routine review a formal evaluation of adequacy and compatibility is prepared and provided to the State. Visits to the States are used to assist them in addressing radiation issues and to monitor their progress in resolving recommendations from the previous routine review.

The routine reviews identify current or potential program deficiencies with recommendations to correct the program deficiencies and facilitate consistency among Regulatory Programs by exchange of ideas between States and the Federal Regulators. The Commission is informed of the results of ;he reviews and copies of the review correspondence to the States are placed in the NRC Public Document Room and the States' Local Public Document Room. Other NRC offices are invited to participate and are involved in maaj of these reviews to assure technical evaluation of all aspects of the Agreement State Program.

There are 30 indicators for evaluating Agreement State Program areas.

Guidance as to their relative importance to an Agreement State Program is provided by categorizing the indicators into two categories. Category I ,

indicators address program functions which directly relate to the State's ability to protect the public health and safety.

Category II indicators address program functions which provide essential technical and administrative support of the primary program functions. In reporting findings to State Management, the NRC will indicate the category of each comment made. If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public- health and -

safety and is compatible with the NRC's program.' If one or more Category I comments are noted as significant, the State will be notified that the program deficiencies may seriously affect the State's ability ~to protect public health and safety and that the need for improvement in particular program areas is critical. The NRC will also make a statement that we are unable to make a finding of adequacy and compatibility at this time.

If a State fails to have compatible regulations in place in the three-year time period they will not be found compatible. The term adequacy refers to public health and safety issues while the term compatibility refers primarily-to regulations. A program may be evaluated as adequate to protect the public health and safety but not compatible.

.o

/

FIVE YEAR STATISTICS ON AGREEMENT STATE REVIEWS December 21, 1992 (Draft Revision)

ALABAMA YEAR 1987 1988 1989 1990 1991 '992 FINDING A&C Visit A Visit A&C* Visit ARIZONA YEAR 1987 1988 1989 1990 1991 1992 FINDING No Visit A&C' Visit A&C' Visit A ARKANSAS YEAR 1987 1988 1989 1990 1991 i FINDING Visit A&C Visit Visit A&C*'

CALIFORNIA YEAR 1987 1988 1989 1990 1991 1992 FINDING A&C Visit A&C Visit A&C*l Visit COLORADO YEAR 1987 1988 1989 1990 1991 1992 FINDING FW Visit FW Visit A&C Visit FLORIDA YEAR 1987 1988 1989 1990 1991 1992

. FINDING A&C Visit A&C Visit A&C Visit GEORGIA YEAR 1987 1988 1989 1990 1991 -1992 FINDING A&C No Visit A No Visit A&C Visit

' Finding of compatibility contingent on final adoption of certain regulations, which usually occurs within 90 days h

Alabama has not adopt regulations for compatibility as of 12/14/92

' Arkansas adopted regulations for compatibility in 6/1/92 JCalifornia's proposed regulations were turned down by the legislature and will need to be resubmitted. Expected resubmittal date 2/93.

I

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10AHO YEAR 1987 1988 1989 1990-VISIT 4/26/91 FINDING A&C Visit Visit, A&C PROBLEMS TERMINATED ILLIN0IS YEAR 1987 1988 1989 1990 1991 1992 b b FINDING Visit, A&C No Visit Visit A&C Visit A&C IOWA YEAR 1987 1988 1989 1990 1991-FU 1992-FU FINDING Visit A&C Visit FW Visit, FW FW KANSAS ,

YEAR 1987 1988 1989 1990 1991 1992 i FINDING A&C Visit A&C Visit A Visit KENTUCKY YEAR 1987 1988 1989 1990 1991 1992 FINDING No Visit A&C Visit A Visit A&C'"

LOUISIANA YEAR 1987 1988 1989 1990 1991 1992 FINDING A&C Visit A&C No Visit A Visit MAINE i

YEAR 1992 1992 FINDING AGREEMENT EFFECTIVE 4/1/92 - A&C Visit l MARYLAND YEAR 1987 1988 1989 1990 1991 1992 FINDING A Visit A Visit A Visit i .

' ' Finding of compatibility contingent on final adoption of certain regulations, which usually occurs within 90 days b

Contingent upon resolution of the 1 millirem per year rule issue

" Kentucky's regulation for decommission has not yet become effective as of 12/14/92 2

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MISSISSIPPI YEAR 1987 1988 1989 1990 1991 1992 FINDING A&C Visit A&C Visit A&C*l Visit HEBRASKA YEAR 1987 1988 1990 12 /90-FU 1992 FINDING Visit A FW A&C FW HEVADA YEAR 1987 1988 1989-FU 1990 1991 1992 Visit A&C' A&C A&C A&C" Visit

, FINDING NEW HAMPSHIRE YEAR 1987 1985 1989 1990-FU 1991 1992 JINDING Visit Visit FW FW A&C FW NEW MEXICO YEAR 1987 1988 1989 1990 1991 1992

, FINDING Visit A&C Visit A Visit A NEW YORK TEAM REVIEW PERFORMED ON ALL NY AGENCIES IN 1990 UNABLE TO MAKE FINDING OF A&C AT THAT TIME ON THE WHOLE PROGRAM NEW YORK CITY HEALTH YEAR 1987-FU 1988 1989 1990 1991 d

FINDING A&C A&C A FW Visit SEW YORK STATE HEAliii YEAR 1987 1988 1989 1990 1991 FINDING No Visit A Visit FW Visit

' Finding of compatibility contingent on final adoption of certain regulations, which usually occurs within 90 days

' Finding of compatibility contingent on final adoption of enforcement procedures New York City Department of Health adopted regulations and found compatible in 8/90 prior to the 10/90 review L

Mississippi adopted regulations for compatibility in 11/15/92

• Nevada adopted regulations for compatibility in 12/9/91 3

l

NEW YORK DEPARTMENT OF LABOR __

YEAR 1987 1988 1989 1990 1991 FINDING A&C ___

Visit A FW Visit NEW YORK DEPARTMENT OF ENVIRONMENTAL CONSERVATION YEAR 1987 1988 1989 1990 1991 FINDING A&C Visit FW FW Visit NORTH CAROLINA YEAR 1987 1988 1989 1990 1991 FINDING A&C Visit A&C Visit Vi sit , A&C*"

9 NORTH DAKOTA YEAR 1987 1988 1989 1990 1991 1992 llNDING A No Visit FW Visit A&C" Visit OREGON l YEAR 1987 1988 1989 1990 1991 1992 FINDING A Visit A&C Visit A&C Visit RHODE ISLAND YEAR 1987 1988 1989 1S30 1991 1992 FINDING A&C Visit A&C' Visit A&C Visit ,

SOUTH CAROLINA I

YEAR 1987 1988 1989 1990 1991 1992 FINDING No Visit Visit A&C Visit A&C Visit

. TENNESSEE YEAR 1987 1988 1989 1990-FU 1991 1992-FU FlHDING No Visit A FW, Visit FW FW FW

• Finding of compatibility contingent on final adoption of certain regulations, which usually occurs within 90 days

• North Dakota adopted regulations for compatibility in 1992 North Carolina adopted regulations for compatibility in 6/19/92 4

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TEXAS YEAR 1987 1988 1989 1990 1991 1992 FINDING Visit A&C Visit A Visit A&C" UTAH YEAR 1987 1988 1990 1991- 1992 f ~c u t.

FINDING No Visit A&C A&C FW A&C' WASHINGTON i

YEAR 1987 1988 1989 1990 1991-FU 1992

[ FINDING A&C A&C Visit A FW A&C

' Contingent upon resolution of licensing actions for Envirocare LLRW disposal license Texas' regulation for decommission has not yet become effective as of 12/14/92. They are expected to be adopted in May or June of 1993.

Note: 1. For routine reviews, "A&C" represents a finding of adequacy and I compatibility, "A" represents a finding of adequacy only and "FW" J represents that the finding was withheld or that tN staff was not able to make a finding that the time of the review. "FU" represents a follow-up review. " Visit" represents the meetings held between NRC and Agreement State between the routine reviews and is usually informal. Correspondence to the State only occurs when there are major problems identified.

5

J Enclosure 9 Memorandum dated August 5, 1976 from Peter Strauss to the Comission 1

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. AugustS , 1976

!LLM0k!dDU1 FOR: Chairnan Rouden Cocsissioner Mason Cozoissioner Gilinshy Commissioner Kennedy T30H: Peter L. Strauss, General Counsel r,vn.!ECT: AUGUST 2,1976 BRIEFING ON RIVIRSIDE !!OSPIT/.L INCIDENT in my view tho'rcsults of this necting represent an appropriate first step to deal with the most pressing ic=ediate prob 1cm cioclosed by the incident, namely the fact that because of calibration errors :anny teletherapy patients throughout the country are probably rocciving doocs significantly different from tnose prescribed. The concluding emphasis of the cect-ing rightly focused on the need to be cure that these ranchines are calibrated correctly now and henceforth.

While the Commission obviously has a paramount concern that future damage be avoided, it also seems clear that action should be taken to identify and remedy where porcible the human con =

sequences of past crrors in dosa3cs. More attention to this subject appcars to be needed than the August 2 bricfing provided. It is ny inpression from the briefin,, and from the documentation of this incident that physicians of Riverside 11ospital patients uho roccived a dose substantially difforcat frem the one prescribed are being notified of this fact. It was not clear from the briefin;, houcver, that an ernsni.'.ed ef fort is bein;; planned to identify patients elseuhere cr.d pro-vide notification cud follow-up, uncro the MBS study or future NRC cvaluations indicato n lil.clihood that dosos in error have been celivered. I recognize that' there is a najor resource grobica in accocplishing this task in view of the fact that 45.0J0 or core paticuts may be involved. As vad rccerni:cd at the briefinn, there are also scusitive questions concern-in; possibic liability of the hospitals. Nevertheless, tbc

~

"potentially explosivc" nature of the affair tches it prudent an well oc huunne for the NRC in its position of radiation safety leadership to make.a substantial effort to ancist thouc uno imy have been injured.

centact:

l E.L. Sleggic 492-5155

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RC consultant Dr. Saenger, in his letter of May 26, 1976, ir.dicates that many month.4 of study are needed, once an erroneously doacd patientThus is identified, to consider fully a prograts for identifying _

the needs of the patient,  :

pntiento affected by these errors and notifying their physicianu is needed pro =ptly and probably should cocaence  :

durinr, the l'RC pro;; ram for correcting existing calibrationOnce t crrors. ao latter program is offectively unden/ay, the . . 1 question of hou best to proceed with identification and notific -

tion migl?t bo the subject of a future Co=aission briefing.

l cc Ben lluberman SUCY (2)

Lcc Cossick '

R. J. Voegeli i

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