ML20062E386

Report to Congress on Abnormal OCCURRENCES.April-June 1990

ML20062E386
Person / Time
Issue date:	10/31/1990
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
NUREG-0090, NUREG-0090-V13-N02, NUREG-90, NUREG-90-V13-N2, NUDOCS 9011200187
Download: ML20062E386 (34)

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NUREG-0090 Vol.13, No. 2 Reaort to Congress on Abnorma: Occurrences April-June 1990 U.S. Nuclear Regulatory Commission OITice for Analysis and Evaluation of Operational Data

y procedures to determine if the treatments were consistent with the prescriaed doses and treatment plans. The licensees were also required to submit proposed license amendments to provide quality assurance procedures i should they desire to continue their brachytherapy programs. The licensees were not to resume brachytherapy procedures without NRC authorization. l Future reports will be made as appropriate. 3 90 12 Radiation Overexoosure of a Radioarapher The following information pertaining to this event is also being reported concurrently in the Federal Register. Appendix A (see Example 1 of "For All Licensees") of this report notes that exposure of the skin of any individual to 150 rem or more of radiation can be considered an abnormal occurrence. Date and Pl Et - April 6, 1990; Barnett Industrial X-Ray; Stillwater, Oklahoma; the radiation overexposure occurred at a temporary jobsite in Ardmore, Oklahoma, 1 Nature and Probable Conseauences - On the evening of April 6,1990, the licensee notified the NRC that an incident had occurred earlier that evening while a radiographer and his assistant were working at a temporary jobsite. The radiographic operation involved the use of a radiography device containing an approximately 80-curie iridium-192 sealed source. (A radiography device uses a radioactive sealed source to make x ray-like images of welds and heavy metal objects. The position of the source is controlled by a drive cable I which is used to crank the source out of the exposure device t.nd retract it l back to a shielded position within the device via an unshielded source guide l tube.) The licensee reported that the source became disconnected from the l drive cable and remained in the source guide tube. Unaware that the source l remained in the tube, the assistant wrap)ed the source guide tubs around his neck while he moved equipment at the wor (site. The licensee initially estimated that the assistant received an exposure of 4000 rem to the exposed area of his neck. Two NRC Region IV inspectors were dispatched the following morning to investigate the incident. The circumstances associated with the radiation overexposure are described below. After comaleting two radiographs of a pipe weld, the radiographer proceeded to develop tie radiographs while the assistant disassembled the-equipment to move the exposure device to another location. While doing this, he removed the source guide tube and draped it around his neck so that his hands would be free to carry the remaining equipment. He walked approximately 30-50 feet before stopping to set the equipment down. As he removed the guide tube from around his neck, he ncticed that the sealed source fell from the tube to the ground. The assistant notified the radiographer who telephoned the company owner and, following his direction, successfully retrieved the source to a shielded position within the exposure device. Dering his conversation with 1 the owner, the radiographer identified: (1) that he failed to conduct a radiation survey of the exposure device after each of the exposures, (2) that the assistant's pocket dosimeter had gone offscale (greater than 200 millirem), and (3) that the assistant was not wearing his film badge during these operations. Under the owner's direction, the assistant was taken for medical examination at a local hospital later that evening. Based on interviews tenducted with the radiographer and company owner together with NRC reenactments of the radiographer's actions during the event, NRC inspectors determined that he might also have received an exposure in excess of regulatory limits. When the radiographer later confirmed that his pocket _ dosimeter had gone offscale, his film badge was sent for immediate processing. Both the assistant and radiographer were referred for examination by a 4 -1 1 i radiation oncologist (a physician experienced in examining patients who have been treated with large doses of radiatioa) and blood samples were obtained for. cytogenetic studies. The. cytogenetic studies revealed equivalent whole body doses of 17 rem for the radiographer and 24 rem for the assistant. The assistant developed an area of erythema on the left side of his neck, which later showed signs of more significant damage to skin tissue in an area approximately 10 centimeters in diameter. The oncologist determined that the observed effect correspended to a local skin dose of 5000-7000 rem. As of June 1990, the skin tissue in this i area had regenerated and the physician did not predict any long-term effects i as a result of this exposure. The assistant remains under the physician's care, and the NRC continues to receive reports on his progress. There were no medical effects observed for the radiographer. Cause or Causes - The radiographer and assistant failed to conduct a radiation survey of the exposure device after either of the exposures was completed to ensure that the source had been retracted to its shielded position. The radiographer was exposed to the unshielded source as he changed films between - the two exposures, and the assistant received a large exposure as he carried the source tube containing the source draped around his neck. Without a o radiation survey, neither individual was aware that the source had not been connected to the drive cable and remained in the guide tube. - Actions Taken to Prevent Recurrence Licensee - The licensee's proposed corrective actions include retraining the radiographer in radiation safety procedures and continued observation of his performance. The assistant radiographer is no longer employed by the licensee. HBG - During the investigation of this event, on April 12, 1990, an Order . modifying the license was issued, prohibiting the radiographer and assistant from participating in licensed activities-(Ref. 3). This Order has since been -relaxed due to the licensee's implementation of corrective' action. NRC Region IV_ conducted an enforcement conference with the licensee on May 25, 1990, to discuss the event (Ref. 4). On September 7, 1990, the NRC issued to the J licensee a Notice of. Violation and Proposed Imposition of Civil Penalty in the amount uf $7,500 (Ref.- 5). The basis for the proposed penalty were violations associated with failure to conduct the required radiation survey and the resultant overexposures. These two violations collectively were classified as . Severity Level 1 (on a scale of Levels I through V, in.which Level I is the most significant). Unless new, significant information becomes available, this item is considered ' closed for the purposes of this report. t, 5 9m2 ..i y+--*-_ 90-13 Medical Diaanostic Misadministration The following information pertaining to this event is also being reported concurrently in the Federal Register. Appendix 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. J Date and Place - June 5,1990; Mercy Memorial Medical Center; St. Joseph, Michigan. Nature and Probable Conseauences - A 79-year-old female prtient was scheduled to undergo a diagnostic evaluation to determine whether she was suffering from-an enlarged thyroid gland (substernal thyroid). No prescribed dose was -indicated. i The scan was scheduled for the following day. The technologist, in attempting to order the proper amount of radioactive material, noted that her standard dose chart (created by authorized users) did not list dosage for a substernal I thyroid gland study. She then referred to the department's procedures manual, which indicated that I the proper dose for a substernal thyroid gland study was 3-5 millicuries of iodine-131, or 100-200 microcuries of iodine-123. The technologist then asked an authorized user which isotope to use. He instructed her to order a sufficient quantity of iodine-131 to visualize the thyroid gland. On June 5, t p' 1990, the patient was given 4.3 millicuries of iodine-131, which conformed to the procedures manual. The dosage listed in the procedure, however, was wrong. The standard dose for a substernal thyroid scan should have been 50 to 100 microcuries of iodine-131, or approximately one-fiftieth of the amount noted in the manual. The mistake was identified by the Chief of the Nuclear Medicine Department on June 6 and reported as a misadministration to the NRC on June 8, 1990. The: licensee estimated that the misadministration resulted in a mean dose to the thyroid gland of 5,752 rads. The NRC's medical consultant investigated the case. Based on certain. assumptions, the consultant estimated the dose to be 3,400 rads to the thyroid gland which, according to the consultant, would ' yield a 10_ percent chance of hypothyroidism over five years. The licensee is monitoring the patient's condition. Cause or causes - The Nuclear Medicine. Department's procedures manual listed the wrong iodine-131 dosage for a substernal thyroid scan. The dosage was not i reviewed by an' authorized user prior to its administration. Actions Taken to Prevent Recurrence Licenseg - The license has been amended to incorporate the following changes in iodine-131 procedures: (1) Two nuclear medicine technologists will independently verify the prescribed dosage and check the dose calibrator assay; (2) A written prescription by an authorized user will be required before the procedure is carried out; and (3) Two signt'.ures or initials will be required on-all documents involving iodine-131. The licensee also 6 i corrected the department's procedures manual to reflect the proper dosage for a substernal thyroid scan. Dosage for a substernal thyroid scan also was added to the department's Standard Dose Chart. HRC - An NRC inspection was conducted on June 19, 1990 (Ref. 6). Seven violations of NRC requirements (unrelated to this event) were identified. The licensee's corrective actions to prevent recurrence were found to be -satisfactory. The NRC notified its medical consultant who reviewed the circumstances. He made certain procedural recommendations for consideration by the licensee. This item is considered closed for the purposes of this report. 90-14 Administration of Iodine 131 to a lactatina Female With Votake by Her Inf)At The following-information pertaining to this event is also being reported concurrently in the federal Register. Appendix 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 - June 19, 1990; Tripler Army Medical Center; Honolulu, Hawaii. Nature and Probable Conseouences - A nursing mother was given a 4.89 millicurie dose of iodine-131 at an' NRC licensed medical facility that resulted in an unintentional radiation dose to her infant's thyroid gland estimated at 30,000 rads and a dose to the infant's whole body of 17 rads.

The error was' detected on June 21, 1990, when the patient returned to'the medical center for a whole body scan. The scan indicated an unusually high breast uptake of iodine-131.

In the opinion of the patient's physician and an 'NRC medical consultant, the infant's thyroid function will be completely lost. The infant will require artificial thyroid hormone medication for life to ensure normal growth and development. -Cause or Causes - The physician and nuclear medicine technologist failed to confirm that the patient was not breast feeding. The patient arrived at the - medical center from a remote South Pacific island. Communication between the island physician and the Army physicians was poor and' the Tripler physicians. were not aware that the_ mother had given birth on June 1, 1990. Actions Taken to Prevent Recurrence Licensee - Immediately following discovery of the error the licensee began. using a new questionnaire that more clearly requires the collection and documentation of information concerning patient pregnancy and breast feeding. The Commanding Officer has ordered a special investigation to define the cause and a)propriate corrective actions. The licensee has contacted the patient and tie patient's physician and is finalizing arrangements for long term follow-up medical care. 7 l M C - An Enforcement Conference was held on August 16, 1990, and enforcement action is being considered. Future reports will be made as appropriate. 90-15 Medical Theraov Misadministration The following information pertaining to this event is also being reported concurrently in the federal Register. Appendix 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 - June 22, 1990; St. Luke's Hospital; Cleveland, Ohio. Nature and Probable Conseauences - A 57-year old woman, being treated for lung cancer, was erroneously given a 178 rem radiation dose to the left side of the head on June 22, 1990, using the licensee's cobalt-60 teletherapy unit. The patient was scheduled to receive a 200 rem radiation dose to the chest area at the time of the misadministration. The treatment was the ninth of a total of ten treatments in the series for a total of 2,000 rem to the chest. The treatment began June 11, 1990. A technologist set the patient up for brain irradiation without looking at the treatment documents. After the left side of the head was treated, the patient asked if her chest would also be treated. At this time, the treatmerf. staff s discovered the error. Because the misadministration involved a single treatment and because of the dosage involved, no adverse medical effects are expected. Subsequent to the misadministration, the patient received.the intended 200 rem radiation dose to the chest area. The tenth treatment was administered, and the patient began a second phase of 25 radiation treatments of 150 rem each to the chest area. Giuse or Causgi - This misadministration was caused by the failure _of the technologist to examine the treatment documentation (the setup sheet and a treatment field picture). Although the technologist had previously treated the-patient, the technologist erroneously assumed the brain was the area to be treated. (The staff determined that although lung cancers of this type often do metastasize to the brain, the irradiation of the brain in this case was a misadministration nonetheless.) Actions Taken to Prevent Recurrence Licensee - The licensee has revised its procedures to require the verification, when circumstances permit, of the treatment setup by a second technologist using the setup documentation. All technologists have been trained in the procedure. The NRC is requesting the licensee to amend its quality assurance procedures to include dual verification of treatment setups prior to any treatment. 8 NE - 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 this period, the Agreement States determined that one of these events was an abnormal occurrence. AS90-1 Medical Diaanostic Misadministration 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. Date and place - November 1,1989; Desert Samaritan Hospital; Phoenix, Arizona 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 millheies 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. schWuled. 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 A hospital employee and an ARRA representative surveyed and decontaminated the patient's house. Wipe tests were used to verify the efficiency of the decontamination. Cause or causes - There were several causes for this event. The hospital staff: did not assay the dose in the dose calibrator prior to o administering it, did not compare the iodine-131 dose label with the physician's o order, and did not maintain adequate records of incoming o radiopharmaceutical s. 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 so that o the units for microcurie and millicurie could be differentiated, and did not record the type of intended procedure (diagnostic or o therapeutic). Actions Taken to Prevent Recurrence Aaency - The ARRA placed an order on the hospital that reduced the possession limit for iodine-131 from 500 millicuries to 100 microcuries (0.1 millicurie). The ARRA also cited Syncor and imposed an order limiting them from dispensing any dose of iodine-131 in excess of 1 millicurie unless a written order from the client-licensee was in the possession of the radiopharmacist dispensing the. dose, l.ater, the ARRA sent a Notice of Violation to the licensee and imposed a civil--penalty in the amount of $12,000. Hospital - The hospital-amended its Nuclear Medicine Department administrative - procedures and paid the civil penalty in full. The order restricting iodine-131 possession limits to 100 microc'uries was rescinded by the ARRA on. March 9, 1990.- Radiopharmacy - The radiopharmacy adopted policies to be used when iodine-131 -l therapy orders.were received and dispensed. The ARRA issued a license amendment incorporating required procedures for orders'for more than 1 millicurie of iodine-'131. The order limiting the amount of iodine-131 that could be dispensed was withdrawn by the ARRA on January 9, 1990. This item is considered closed for the purposes of this report. 10 REFERENCES 1. Letter from James Lieberman, NRC Director of Enforcement, to Scott Hardtman, Vice President, Operations, St. Mary Medical Center - Hobart and St. Mary Medical Center - Gary, transmitting, " Order Suspending Brachytherapy Activities and Modify'.ng Licenses," April 27, 1990.* 2. Letter from Hugh L. Thompson, N., NRC Deputy Executive Director for Nuclear Materials Safety, Safeguards, and Operations Support, to Wiley N. Carr, Administrator and Chief Executive Officer, Porter Memorial Hospital, forwarding " Confirmatory Order Suspending Brachytherapy Activities ar,; Modifying License," May 2,1990.* 3. Letter from Hugh L. Thompson, Jr., NRC Deputy Executive Director for Nuclear Materials Safety, Safeguards, and Operations Support, to Loyd D. Barnett, Barnett Industrial X-Ray, transmitting " Order Modifying License," Docket 030-30691, April 12, 1990.* 4. Letter from A. Bill Beach, Director, Division of Radiation Safety and Safeguards, HRC Region IV, to Loyd Barnett, Barnett Industrial X-Ray, transmitting " Enforcement Conference Summary" Docket 030-30691, June 11, 1990

• 5.

Letter from Robert D. Martin, Regional Administrator, NRC Region IV, to Loyd Barnett, Barnett Industrial X-Ray, transmitting a Notice of Violation and Proposed Imposition of Civil Penalty, Docket No. 030-30691, License No. 35-26953-01, September 7, 1990

• 6.

Letter from Bruce S. Mallett, Chief, Nuclear Materials Safety and Safeguards, NRC Region Ill to H. David Claus, Vice President of Administration, Mercy Memorial Medical Center, Inc. forwarding Inspection Report 030-02049/90001, Docket No. 030-02049, license No. 21-04177-01, July 31,- 1990.* 7.- Letter from Charles-E. Norelius, Director, Division of Radiation Safety and Safeguards, NRC Region Ill, to Jeffrey Jarey, Vice President, Services, St. Luke's Hospital, forwarding Inspection Report 030-17512/90001, Docket No. 030-17512, license No. 34-00398-10, July 26, 1990.*

• Available in NRC Public Document Room, 2120 L Street, NW, (Lower Level)

Washington, D.C., for public inspection and copying. 11 m APPENDIX A ABNORMAL OCCURRENCE CRITERIA The following criteria for this report's abnormal occurrence' determinations were set forth in an NRC policy statement published in the Federal Reoister on February 24,1977 (Vol. 42, No. 37, pages 10950-10952). An event will be considered an abnormal occurrence if it involves a major reduction in the degree of protection of the public health or safety. Such an event would involve a moderate or more severe impact on the public health or safety and could include but need not be limited to: 1. Moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Commission; 2. Major degradation of essential safety-related equipment; or .3. Major deficiencies in design, construction, use of, or management controls for licensed facilities or material. Examples of the types of events that are evaluated in detail using these criteria are: For All Licensees 1. Exposure of the whele body of any individual to 25 rem or more of radia-tion; exposure of the skin of the whole body of any individual to 150 rem or more of radiation; or exposure of the feet, ankles, hands or forearms of any individual to 375 rem or more of radiation (10 CFR 20.403(a)(1)], or equivalent exposures from internal sources. 2. An exposure to an individual in an unrestricted area such that the whole body dose received exceeds 0.5 rem in one calendar year (10 CFR 20.105(a)]. 3. The release of radioactive material to an unrestricted area in concentrations which, if averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, exceed 500 times the regulatory limit of Appendix B, Table II,10 CFR Part 20 [CFR 20.403(b)(2)]. 4.- Radiation or contamination levels in excess of design values on packages, or' loss of confinement of radioactive material such as (a) a radiation dose rate of 1000 mrem per hour three feet from the surface of a package containing the radioactive material, or (b) release of radioactive material from a package in amounts greater than the regulatory limit. 5. Any loss of licensed material:in such quantities and under such circum-stances that substantial hazard may result to persons in unrestricted areas. 13

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.-.-,-.,.,il,' ' ' ' ' ' ' '

i i

6..

A substantiated caso of actual or attempted theft or diversion of licensed material or sabotage of a facility.

7.

Any substantiated loss of special nuclear material or any substantiated inventory discrepancy that is judged to be significant relative to normally expected performance and that is judged to be caused by theft or diversion or by substantial breakdown of the accountability system.

8.

Any substantial breakdown of physical security or material control (i.e., access control, containment, or accountability systems) that significantly weakened the protection against theft, diversion, or sabotage.

9.

I.n accidental criticality (10 CFR 70.52(a)].

10.

A major deficiency in design, construction, or operation having safety implications requiring immediate remedial action.

11.

Serious deficiency in management or procedural controls in major areas.

12.

Series of events (where individual events are not of major importance),

recurring incidents, and incidents with implications for similar facilities (generic incidents) that create major safety concern.

For Commercial Nuclear Power Plants 1.

Exceeding a safety limit of license technical specifications [10 CFR 50.36(c)].

2.

Major degradation of fuel integrity, primary coolant pressure boundary, or primary containment boundary.

3.

Loss of plant capability to perform essential safety functions such that a potential release of radioactivity in excess of 10 CFR Part 100 guidelines could result from a postulated transient or accident (.g.,

loss of emergency core cooling system, loss of control rod system.

4.

Discovery of a major condition not specifically considered in the safety analysis report (SAR) or technical specifications that requires immediate remedial action.

5.

Personnel error or. procedural deficiencies that result in loss of plant capability to perform essential safety functions such that a potential release of radioactivity in excess of 10 CFR Part 100 guidelines could result from a postulated transient or accident (e.g., loss of emergency core cooling system, loss of control rod system).

For Fuel Cycle licensees 1.

A safety limit of license technical specifications is exceeded and a plant shutdown is required [10 CFR 50.36(c)].

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.._.,_e 2.

A major condition not specifically considered in the safety analysis repcrt or technical specifications that requires immediate remedial action.

3.

An event that seriously compromised the ability of a confinement system to perform its designated function.

E k

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APPENDIX B UPDATE OF PREVIOUSLY REPORTED ABNORMAL OCCURRENCES During the April through June 1990 period, NRC licensees, Agreement States, Agreement State licensees, and other involved parties, such as reactor vendors and architect-engineering firms, continued with the implementation of actions necessary to prevent recurrence of previously reported abnormal occurrences.

The referenced Congressional abnormal occurrence report below provides the initial and any subsequent updating information on the abnormal occurrence discussed.

(The updating provided generally covers events that took place during the report period; some updating, however, is more current as indicated by the associated event dates.) Open items will be discussed in subsequent reports in the series.

OTHER NRC LICENSES 88-6 Release of Polonium-210 from Static Elimination Devices Manufactured by 3M Company.

This abnormal occurrence, involving the Minnesota Mining and Manufacturing Company (3M), was originally reported in NUREG-0090, Vol.11, No.1, " Report to Congress on Abnormal Occurrences: January-June 1988."

It was updated and closed out in NUREG-0090 Vol. 11, No. 3.

It is being reopened, and then reclosed, to report the following significant proposed enforcement action taken as a result of NRC investigations.

The Nuclear Regulatory Commission Staff proposed a $160,000 fine for willful violations of NRC requirements associated with the leakage of polonium-210 from static elimination devices manufactured and distributed by 3M (Ref. B-1).

The enforcement action was based on insoections conducted by the NRC staff in 1988 and an investigation in 1988 and 1989 by the agency's Office of Investigations. The case was reviewed by the U. S. Attorney in Minneapolis, Minnesota, and that office decided not to undertake prosecution in lieu of the civil sanctions proposed by the NRC.

- As a result of the contamination resulting from leakage of the devices, in 1988 the NRC staff issued a series of four Orders requiring recall of all 3M static elimination devices and prohibiting further distribution.

The company was subsequently permitted to perform research and development work on the design of the device, but the prohibition of distribution remains in effect.

While there was a significant potential for unnecessary and widespread contamination, the radioactive material was in a form that made it unlikely that.any person received a significant radiation exposure or that consumer products were significantly contaminated by the radioactive material.

The NRC investigation and inspection concluded that 3M personnel willfully failed to assure that customers would use the static eliminators in acceptable environments and that the company failed to determine properly the amount of 17

radioactive contamination on static elimination devices returned to the company by its customers.

An $80,000 fine was proposed for these two violations.

A second $80,000 fine was proposed for four additional violations:

the failure of 3M to identify all results of testing and evaluation of returned static eliminators classified by 3M as damaged in annual reports submitted to the NRC for 1986 (violation 1) and 1987 (violation 2); the failure of the company to notify all of its customers (violation 3) and to follow up with its customers (violation 4) the return of damaged leak detectors after it had determined that some returned static elimination devices had removable radioactive contamination on surfaces in excess of NRC limits.

No fine was assessed for a seventh violation:

the failure to obtain NRC review and approval for changes in components in static elimination devices distributed between 1983 and 1988.

The NRC Office of Investigations concluded that one 3M employee: (1) willfully failed to notify 3M's customers of leaking static eliminators, and (2) willfully failed to provide information to the NRC ste . Two more employees likely failed to make accurate reports to the NRC staff and likely demonstrated a careless disregard for the agency's requirements.

A fourth employee failed to become familiar with NRC reporting requirements and, as a result, also submitted inaccurate information to the NRC staff.

The enforcement action (Ref. B-1) also included a " Demand for Information" to assist in determining if there is a reasonable assurance that 3M's licensed activities would be conducted in compliance with agency requirements if these four individuals are associated with NRC-licensed activities.

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

18 I

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APPENDIX C OTHER EVENTS OF INTEREST 1

The following item is described because it may possibly be perceived by the public to be of public health or safety significance.

The item did not involve a major reduction in the level of protection provided for public health or safety; therefore, it is not reportable as an abnormal occurrence.

1.

Reactor Operator Reoualification Proaram Deficiencies at Several Nug].gE Power Facilities In November 1988, the NRC implemented the requalification examination program,

[-

as described in ES-601 of Revision 5 of NUREG-1021, " Operator Licensing Examiner Standards." Of the 79 power reactor facilities that the NRC

, the programs at 10 evaluated against the criteria in ES 601 (Revision 5)ll unsatisfactory program facilities exhibited deficiencies warranting an overa rating.

These facilities are listed in Table C-1.

All facility licensees are required by Section 50.54(i) of Title 10 of the J

Code of Federal Regulations (10 CFR) to implement an operator requalification program that must, as a minimum, meet the requirements of 10 CFR 55.59.

Pursuant to 10 CFR 55.57(b), an operator's license will be renewed if the Commission finds that the operator has successfully completed an approved requalification program as required by Section 55.59 and, among other things, has passed a comprehensive requalification written examination and operating test administered by the Commission during the term of his or her 6-year license.

The procedures contained in ES-601 of Revision 5 of NUREG-1021 were derived based on a Systems Approach to Training (SAT) program and rely on existing requalification program standards for guiding the development and implementation of NRC examinations.

The program evaluates the effectiveness with which the facilities' requalification training programs enable licensed operators to maintain their competency and currency while providing individual operators the opportunity to satisfy their regulatory requirement to pass an NRC requalification examination before license renewal.

The NRC-administered requalification examination is composed of a comprehensive operating test and written examination developed by a team of NRC examiners and facility representatives. The two-phase operating test

[ crew evaluation on a dynamic simulator and individual evaluation using Job Performance Measures (JPMs)] and the two-section, open-reference written examination (static simulator and classroom) are, to the extent practical, based upon the facility's requalification program and its learning objectives.

Generic weaknesses (applicable to more than one of the facilities listed in Table C-1) found during the requalification examinations can be organized into two categories:

" safety and technical" and " program." The safety and r

technical weaknesses included deficiencies in (1) communications within crews; (2) senior reactor operator (SRO) command and control; (3) use of emergency 19

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Table C-1 g

Facilities Receiving an Overall Unsatisfactory Requalification Program Rating

[

Facility Plant Type

• Plant Location Date of flicensee)

NRC Exam Browns Ferry GE-BWR Limestone County, 7/99 (Tennessee Valley Alabama Authority)

Brunswick GE-BWR Brunswick County, 5/90 L

(Carolina Power North Carolina

& Light)

Duane Arnold GE-BWR Linn County, Iowa 6/90 (IowaElectric Light & Power)

LL Ginna W-PWR Wayne County, 6/89 (Rochester New York Gas & Electric)

Limerick GE-BWR Hontgomery County, 1/90 (Philadelphia Pennsylvania Electric)

Millstone 3 W-PWR New London County, 9/89 (l!ortheast Connecticut buclear Energy) r Nine Mile Point 2 GE-BWR Oswego County, 7/89 (Niagara Mohawk New York Power)

Point Beach W-PWR Manitowoc County, 2/89 (Wisconsin Wisconsin Electric Power)

Turkey Point W-PWR Dade County, Florida 3/89 (Florida Power

& Light)

Zion W-PWR Lake County, Illinois 9/89 (Commonwealth Edison)

• GE-BWR means a General-Electric-designed boiling water reactor.

• W-PWR_means a Westinghouse-designed pressurized water reactor, a-20 r-

operating procedures (EOPs); (4) technical specification interpretation and usage; (5) operation of emergency core cooling systems (ECCSs); and (6) emergency action level classification. The program weaknesses included deficiencies in (1) facility evaluator performance; (2) shift staffing and rotation; (3) reference and examination material; and (4) procedure control.

The causes of the deficiencies can be generally attributed to failure to implement adequate standards for training and evaluation of the operators.

In general, corrective actions consisted of licensees performing root cause analysis to identify the major weaknesses and providing remedial training of the operators.

Of the more recent examinations administered by the NRC, the most significant deficiencies were identified at the Brunswick facility.

This event is t

discussed below to provide specifics of the deficiencies and to describe the corrective actions taken by the licensee and NRC.

Requalification examinations were administered by the NRC April 30-May 11, 1990, to 12 SR0s and 8 Reactor Operators (R0s).

Three SR0s and 4 R0s passed these examinations. All others failed.

These 20 operators consisted of 4 crews with 5 licensed operators each.

Three of the 4 crews (and 13 operators) failed the dynamic simulator examinations.

Generic weaknesses were displayed by the crews during the dynamic simulator section of the examination in the areas of control and awareness of plant status, ECCS operations, E0P flow chart usage, and communication skills.

Three crews (of four) failed the dynamic simulator section of the exam due in large part to their inability to maintain a proper cognizance and control of major plant parameters and systems. The command and control weaknesses identified were exacerbated by deficiencies in ECCS operations, E0P usage and communications. These deficiencies were not attributed to all of the operators, but were of a sufficient repetitive nature to be considered pervasive.

Licensee management met with the NRC on May 15, 1990, to agree on compensatory actions to correct deficiencies noted during the examinations. As a result of this meeting, the licensee agreed to place an additional Operations Supervisor (who has an operator's license) on each shift, provide remedial training to all licensed operators (while removing from shift the operators who did not pass the administered examination) and participate with the NRC in operational evaluations of the operators not previously evaluated.

Operational Evaluations on the simulator were administered to 4 crews, a total of 27 operators, on May 18-19, 1990.

The NRC determined that 4 of the 4 crews evaluated, and 8 of 27 operators performed unsatisfactorily during these evaluations. As a result, the licensee placed both Brunswick units in cold shutdown to allow for crew reconstitution, training and re-evaluation prior to continued operation of the facility.

The cause of the deficiencies was failure to implement adequate standards for training and evaluation of the operators on operation of the facility's emergency systems during abnormal and emergency situations.

The licensee's recovery plan involved both short and long term corrective actions.

In the 21 l

short term, the licensee provided remedial training to a sufficient number of reconstituted operating crews to support restart of both units. Operational Evaluations were conducted on June 9-10, 1990, by the NRC prior to restart.

The result provided the licensee with sufficient licensed operators to safely start-up and resume power operation of both units.

Both units were returned to power operation as of June 11, 1990.

The NRC conducted additional Operational Evaluations on July 25 26, 1990, to ensure that a sufficient number of qualified operators were available for continued power operation of both units. The licensee completed a root cause analysis to identify the major weaknesses and contributors that led to the unsuccessful operator performance on the NRC administered requalification examinatien.

The scheduled corrective actions will result in the licensed operator

(-

requalification training program being ready for NRC re-evaluation by April 1991.

Prior to conducting-this reassessment, the status of the licensae's corrective actions and training program will be reviewed during an NRC training inspection.

On August 28, 1990, the NRC issued Information Notice No. 90-54, " Summary of Requalification Program Deficiencies" (Ref. C-1) to all holders of operating licenses or construction permits to alert licensees to problems identified during administration of the NRC's licensed operator requalification examination program. This notice addressed technical and program weaknesses generic to the 10 facilities listed in Table C-1.

22

REFERENCES FOR APPENDICES B-1

-Letter from Hugh L. Thompson, Jr., NRC Deputy Executive Director for Nuclear Materials Safety, Safeguards, and Operations Support to Allen F.

Jacobson, Chairman and Chief Executive Officer, Minnesota Mining and F

Manufacturing Company (3M), forwarding Notice of Violation and Proposed Imposition of Civil Penalty - $160,000 and Demand for Information, June 7, 1990.*

C-1 U.S. Nuclear Regulatory Commission, NRC Information Notice No. 90-54,

" Summary of Requalification Program Deficiencies," August 28, 1990.*

w L

E E-

• Available in NRC Public Document Room, 2120 L Street, NW (Lower Level),

Washington, D.C., for public inspection and copying.

23

U.S. NUCLE AR REGUL ATDRY COMNitS510N

1. R 1N t

80RM 335

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IloDE BIBLIOGRAPHIC DATA SHEET wm,,ver.om o,,,a, mer /

NVREG-0090 Vol.13, No. 2

a. m LE AND buBM LE Report to Congress on Abnormal Occurrences:

3 D ATE HEPORT PJBLISHED MOYH

%iAR April - June 1990 October 1990

4. F IN OR GR ANT NUMBE R

6. TYPE OF REPORT

6. AUTHORtSI Quarterly L PERlOD COVER E D fraceuswe Defed April - June 1990

8. PE R F ORMING, ORG ANIZ AT lON + N AM E AND ADDR E SS IJr NRC. preense Dwisson. Offsce or needon. V.1 Nuc8rd' A'eudd'*'y

n..- m iu, n~ >

Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20555

9. SPONSORING ORG ANIZ ATION - N AMi AND ADDR ESS fit NRC. tver "Som* ** *tsove'

to"*'**'. p'ovne NRc unwon. Ottoco c:Reeson. V 5 Nue***v k*uviatory Com'"*ssen.

Onst Mae4Nng edtfrosLi Same as 8.,

above

10. SUPPLE ME NT ARY NOTES

11. ABST R ACT (200 words or Arus Section 208 of the Energy Reorganization Act of 1974 identifies an abnormal occurrence

.as an unscheduled incident or event which the Nuclear Regulatory Commission determines

'to be significant from the standpoint of public health and safety and requires a quarterly report of such events to be made to Congress.

This report covers the period

~ April 1 through June 30, 1990. The report discusses six abnormal occurrences, none involving a nuclear power plant. There were five abnormal occurrences at NRC licensees:

(1) deficiencies in brachytherapy program; (2) a radiation overexposure of ia radiographer; (3) a' medical diagnostic misadministration; (4) administration of I-131 to a lactating female with uptake by her infant; and (5) a medical therapy misadministration.

An Agreement State (Arizona) reported an abnormal occurrence'

-involving a_ medical diagnostic misadministration.

The report also contains information that updates a previously reported abnormal occurrence.

it avas6Assui y sr ArgusNr

12. K E Y WOH DS/DE SCRtP T ORS fuse wason ar parews raer ein es,4t researrners m iocateng rae ceport.s Unlimited

14. $t CURii V C LA 558 F 46.A I Keh

.. Management Deficiencies at Medical Centers; Radiographer Radiation Overexposure; Medical Diagnostic and Therapy Misadministrations; Unclassified Unintentional Radiation Dose to an Infant.

,r u,,ori, Unclassified 16 NUMBLR OF PAGE S 16.PRlGk NRC f ORM 3M (J 89) -

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4 THIS DOCUMENT WAS PRINTED USING RSCYCLED PAPER.

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NUCLEAR R TORY MMISSION

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j OFFICIAL BUSINESS PENALTY FOR PRIVATE USE 4300 E

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