ML20236A441

NMSS Licensee Newsletter

ML20236A441
Person / Time
Issue date:	09/30/1988
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N88-3, NUREG-BR-117, NUREG-BR-117-N88-3, NUDOCS 8903170208
Download: ML20236A441 (8)

Text

DP" 1' SDR NMSS Licensee Newsletter U.S. Nuclear Office of Nuclear NUREG/BR-0117 if(Q)>) Regulatory Material Safety No. 88 3 Commission and Safeguards September 1988 k.W....f NEW DECOMMISSIONING RULE ISSUED of a prescribed amount of money, as specified in the rule, by a method acceptable to the Commission.

The U.S. Nuclear Regulatory Commission (NRC) issued a final rule," General Requirements for Decommission. License Terminations: The new rule requires that licensees ing Nuclear Facilities,"in the Federal Register on June apply for license termination and submit a completed 27, 1988. The rule sets forth technical and financial form NRC-314 and results of a final radiation survey, criteria on the decommissioning of nuclear facilities and when all activities involving authorized materials have the termination of licenses. It applies to licenses for been terminated. Where NRC has not approved final byproduct, source and special nuclear material that NRC decommissioning procedures, and these could increase issues under 10 CFR Parts 30,32 to 35,40 and 70. The potential health and safety impacts to workers or the new rule covers planning for decommissioning, financial public, the licensee must submit them for review and ap-assurance of funding for decommissioning, license ter. proval, before their implementation in a fm' al decommis-mination procedures, and record keeping. NRC has sent sioning plan. The final plan, if required, must contain copies of the new rule to all licensees. an updated cost estimate for decommissioning and a plan for assuring the availability of adequate funds.

Licensees and applicants must implement certain features of the new rule as of the rule's effective date, July 27, Record-Keeping: The new rule requires that licensees 1988. These features include requirements for new ap- maintain certain records important to safe and effective plications and license termination requests, and re- decommissioning, in an identified location, until NRC quirements for record-keeping to facilitate decommission- terminates the license. These include records of spills or ing. The following describes these new requirements in other contamination events, as-built drawings and summary fashion; alllicensees should review the f'mal rule modifications of structures and equipment in restricted to see how it applies to them, areas, and records of decommissioning plans, cost estimates, and financial assurance measures.

Eristing Licenses: Provisions of the rule requiring decom-missioning funding plans and financial assurance cer* CESIUM LEAK SHUTS DOWN GEORGIA tifications apply to holders of existing licenses exceeding IRRADIATOR prescribed possession limits, after a two-year grace period which will end on June 27,1990. (Future editions of the A large irradiator in Decatur, Georgia, near Atlanta, was A AfSS Licensee Newsletter will discuss these aspects of shut down in June, because of a cesium-137 leak. The the new mie.) State of Georgia licensed the facility, which Radiation Sterilizer, Inc., operates to sterilize medical products. On i

A.cw Applications: P :pending on possession limits for learning of the cesium leak, the State of Georgia, the U.S.

radioactive material, as prescribed in the new rule, new Nuclear Regulatory Commission (NRC), and the U.S.

applications submittcJ after July 27, 1988 may be sub- Department of Energy (DOE) responded promptly. It is Ject to requirements for inclusion of a decommissioning believed that no significant contamination escaped from funding plan or a certification of financial assurance for the facility. The facility remains shut down pending decommissiomng. A decommissioning funding plan, if c eanup by the licensee and DOE contractors. Both the required, must include a cost estimate for decommission- State of Georgia and DOE are investigating the incident.

ing and a plan for assuring the availability of sufficient funds to perform decommissioning by an acceptable The irradiator contains about 12 million curies of method, as specified in the rule. A certification of finan- cesium-137 wa'ste in double-walled, stainless steel storage cial assurance, if required, must assure the availabihty capsules made by a DOE contractor facility in the State of Washington. The Georgia facility apparently did not 8903170208 880930 PDR NUREG BR-0117 R PDR

. 1, have sophisticated leak-test capability. The leak apparent- NRC requirements. NRC lifted the second license suspen-ly was identified by excess direct radiation levels in the sion only after the company removed Welt from office irradiation chamber when the sources were fully shielded, and made other organizational changes.

DOE and DOE contractors are still trying to determine the cause of the leak. Once NRC completed its investigation, it gave the evidence it had obtained to support criminal charges to Four licensed irradiators use DOE cesium waste capsules, the U.S. Department of Justice (DOJ), which presented and all are being carefully monitored. In addition to the the evidence to a Grand Jury. DOJ obtained indictments Georgia facility, Radiation Sterilizer operates a similar against RTI, Welt, and two former operations managers irradiator in Westerville, Ohio. Both facilities are " wet at the Rockaway facility. The company and the two storage-dry operation" itradiators. The Ohio facility former managers subsequently entered guilty pleas, RTI also shut down as a precaution, until at least some of the to two counts of providing false information to NRC, cesium sources could be returned to DOE. Cobalt-60 and the former managers to one count each of conspir-sources will be used as replacements. ing to defraud NRC. Welt pleaded not guilty, but was subsequently convicted in a jury trial on six of seven The two other irradiators, Applied Radiant Energy Cor- criminal counts, including lying to NRC inspectors and poration in Virginia and lotech in Colorado, are designed investigators, conspiracy to defraud the NRC, and inten-differently from the Georgia facility, in the Virginia tionally violating the Atomic Energy Act. The jury was facil!ty, the sources remain shielded under water at all unable to reach a verdict on an obstruction of justice times, and at the Colorado facility, the sources are usually charge.

dry during both storage and operations. Because these types of operations appear more stable, and do not put On October 11, 1988, Welt was sentenced to serve two sources through " wet-dry" cycles, they have remained in concurrent sentences of two years. He was also assessed use pending the outcome of the DOE investigation. a fine of $50,000. RTI was fined $100,000. The two managers were sentenced to three years of probation and

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• LICENSEE CONVICTED OF LYING TO THE U.S.

NUCLEAR REGULATORY COMMISSION (NRC)

SIGNIFICANT ENFORCEMENT ACTIONS On July 13,1988, Martin Welt, the founder and former AGAINST MATERIALS LICENSEES president of Radiation Technology, Inc. (RTI), was found guilty of lying to NRC about safety violations ac One way to avoid regulatory problems is to be aware of the company's Rockaway, New Jersey, plant. Welt was enforcement problems others have faced. Thus, we have also convicted on several other Federal charges at the con- included here a discussion of some representative enforce-clusion of the two-week trialin the District Court of New ment actions against materials licensees. These enforce-Jersey, ment actions include civil penalties, orders of various types, and notices of violations.

RTI cperates four irradiators (at Rockaway and Salem in New Jersey and at Haw River, North Carolina and A. Enforcement Actions involving Civil Penalties and West Memphis, Arkansas). These facilities use the intense Orders gamma radiation from large quantities of encapsulated 1. Aztec Laboratories, Kansas City, Missouri Sup-cobalt-60 for the sterilization of medical products, spices plements IV and VI, EA 87-84 and other items. During a 1984 mspection of the Rockaway plant, an NRC inspector determined that safe. A Notice of Violation and Proposed Imposition ty interlocks designed to prevent entry to the irradiator of Civil Penalty was issued on June 30, 1987, cell while the cobalt-60 was unshielded apparently had based on several violations involving failures to:

been deliberately bypassed. A followup investigation (1) make surveys as were reasonable under the revealed that this action was taken with the knowledge circumstances to evaluate the extent of radiation and approval of Welt, who was then the president of the hazards that were present after a fire;(2) report company and radiation safety officer at the facility. A an event involving licensed material that caused subsequent inspection and investigation at the Rockaway damage to property in excess of $2,000; (3) secure plant in 1986 revealed additional examples of lying to licensed materials in an unrestricted area from NRC inspectors and investigators by Welt and other com. unauthorized removal; (4) test for leakage and/or pany officials, and other efforts to prevent NRC from contamination at intervals not to exceed six learning about the violations of regulatory requirements, months; (5) maintain records of inventories as re-quired; and (6) use licensed materials only at Identification of these violations resulted in NRC orders authorized locations. The licensee responded in suspending the license of the Rockaway facility on two a letter on July 21,1987. After consideration of different occasions in 1986, on the first for ten days and the licensee's response, the staff concluded that the second for two months. NRC allowed operation to the violations did occur and an Order Imposing resume after the first suspension only when the company the Civil Penalty was issued on September 28, hired a full-time independent auditor, reporting to the 1987. The licensee responded in letters dated RTI Board of Directors, to assure that management was November 7 and 9,1987 requesting mitigation operating the plant safely and in full compliance with of the civil penalty. After reviewing the response 2

and the licensee's financial condition, NRC 5. Micromedic Systems, Inc.,

allowed the licensee to pay in 12 monthly Horsham, Pennsylvania installments. Supplements IV and VI, EA 87-241 A Notice of Violation and Proposed Imposition

2. Eastern Testing and Inspection, Inc.,

Pennsauken, New Jersey f Civil Penalty was issued on March 29,1988, based on improper disposal of radioactive waste Supplements IV and V, EA 87-79 ,

materials and three examples of the failure to A Notice of Violation and Proposed Imposition perform adequate surveys, as required at the of Civil Penalties was issued on July 24,1987, facility.

based on several violations involving failures to:

(1) maintain an audible warning signal to a per- 6. Osage Wireline Service, Cleveland, Oklahoma manent radiography cell in an operable status; Supplements IV, V, and VI, EA 87-178 (2) use dosimeters properly (radiographic person-

, A Notice of Violation and Proposed Imposition ne:); (3) audit activities of certain radiographic personnel at the required frequency (manage- of Civil Penalty was issued on December 22, ment); and (4) transport a radiographic source 1987, based on numerous radiation safety viola-tions, including failures to: (1) handle radioac-to a field site with the required shipping papers. g;g The licensee responded in two letters /.ated g g g August 21, 1987. After consideration of the surveys at job sites; (3) maintain records of in-ventories of radioactive sources; (4) secure licensee's responses, an Order Imposing Civil radioactive sources from unauthorized removal; Penalties in the amount of $3,250 was issued on October 20,1987; the licensee was given permis- and (5) maintam complete re ords of person-nel m nitoring results. The bcensee responded sion to pay in 24 monthly installments.

in letters dated January 28, 1988. After con-sideration of the licensee's response, the staff

3. Frochling and Robertson, Inc.,

Richmond, Virginia concluded that one violation should be withdrawn and the civil penalty be reduced by Supplements V and VI, EA 87-128 ,

$50. An Order imposing a Civil Penalty in the A Notice of Violation and Proposed Imposition amount of $1.,450 was issued on May 27,1988.

of Civil Penalty was issued on November 6,1987, based on violations involving failures to: (1) ad- 7. Professional Service Industries, Inc.,

minister periodic or refresher training; (2) con- Lombard, Illinois duct quarterly inspections of all operations in the Supplement VI, EA 88-93 Radiation Safety Officer's area of responsibili-ty; (3) reevaluat ihe ot crall Radiological Safety A Notice of Violation and Proposed Imposition Program at least quarterly; (4) return film badges f Civil Penalty was issued on May 19, 1988, monthly for measurement; and (5) use applicable based on failure to secure a moisture density shipping labels when shipping radioactive gauge during transport, which resulted in the material. The licensee responded in letters dated temporary loss of the gauge after it fell onto a December 1,1987. After consideration of the pubh,c road from the back of the licensee's licensee's responses, the staff concluded that two vehicle.

of the violations should be withdrawn. An Order

8. Riverton Memorial Hospital-Health Trust, Imposing a Civil Penalty in the amount of $4,200 was issued on April $,1988. Inc., Riverton, Wyoming Supplement VI, EA 88-107

4. Joslin Diabetes Center, Inc., An Ordet "odifying License and Notice of Boston, Massachusetts Violation and Proposed Imposition of Civil Supplements IV and VI, EA 88-54 Penalty was issued on June 3,1988, based on unauthorized use of licensed material, failure to A Notice of Violation and Proposed imposition instruct individuals, and various other viola-of Civil Penalty was issued on April 5,1988, ,

tions, four of which were repeats of the previous based on several violations, including a inspection findm, gs. The base civil penalty was cumulative radiation exposure of 35.U cm o, the right hand of a research investigate a..r* T *"C'. eased by 100 percent due to inadequate cor-rective actions and poor prior performance. The the fourth calendar quarter of 1987. ,

Order Modifying License required the licensee The licensee responded in a letter dated April to notify NRC of personnel terminations and 28, 1988. After consideration of the licensee's obtain an independent consultant to assess the response, an Order Imposing a Civil Penalty in program and perform audits.

the amount of $625 was issued on June 13,1988.

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9. Southern Ohio Coal Company, Athens, Ohio POTENTIAL SIGNIFICANT EQUIPMENT Supplement VI, EA 88118 PROBLEM A Notice of Violation and Proposed Imposition of Civil Penalty was issued on May 27,1988, .. . . I This mformation is provided to alert you to a potential-based on the licensee's failures to: (1) maintain ly s gmficant equipment problem, namely, misrepre-adequate control over a device containing a sented, substandard equipment and parts.

cesium-137 radioactive source and (2) conduct a physical inventory every six months, to ac. .

j This problem, which appears to be pervasive, involves '

count for the radioactive source. As a result of these failures, the radioactive source may have counterfeit, substandard, or questionable equipment and equipment parts such as fasteners, piping materials, cir-been lost in the public domain. The base civil cuit breakers, valves, and protective ; relays, etc. Refur-penalty was increased by 50 percent, because corrective actions, after identification of the bished equipment has been sold as new; madequately refurbished equipment has been supplied with false cer-loss, were not promptly initiated and were only tification. The Office of Nuclear Reactor Regulation's minimally acceptable.

(NRR's) inspection teams discovered that such deficient equipment is being used in nuclear power plants. In ad-  ;

10. St. Louis University, S.. Louis, Missouri dition, a similar problem has been found in non-nuclear l Supplement IV, EA 87-234 mdustrial operations, as well. The U.S. Nuclear  ;

A Notice of Violation and Proposed imposition Regulatory Commission (NRC) has issued numerous )

of Civil Penalty was issued on January 29,1988, Compliance Bulletins and Information Notices on this  ;

based on actions involving: (1) permitting an in- problem to holders of nuclear reactor operating licenses dividual to receive a whole body dose of at least and/or construction permits for nuclear power reactors, 7.5 rem during the fourth calendar quarter of for review and consideration, if necessary. Because this 1987; (2) failing to assess the radiation hazards problem is so widespread, we urge all Office of Nuclear l or observe three separate warning lights which Material Safety and Safeguards (NMSS) licensees and I would have alerted the individuals, before enter- vendors to carefully consider whether this equipment pro-ing the room, that the 8900-curie cobalt-60 blem applies to your equipment and procurement teletherapy source was in an exposed position; practices.

and (3) failing to report to NRC, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, that an overexposure event had occur- In particular, we alert you to a potential equipment prob-red. A Severity Level 11 was proposed and the lem in the electrical area, with components such as switch-base civil penalty was increased by 50 percent gear, fasteners, interlocks, and safety instrumentation.

because the licensee's corrective actions were not prompt and were only minimally acceptable. Although your operation might not be as complex or The licensee responded in a letter dated demanding of quality as a nuclear power plant, consider February 16, 1988. After considering the which features of your operation are essential to con-licensee's response, the staff concluded that the tinued operation or to safe operation, and what actions violations did occur and an Order Imposing a you would find prudent and reasonable to assure con-Civil Penalty was issued on May 3,1988. tinued safe operation.

B. Enforcement Actions Involving Notices of Violation if you have any questions or need further information, y u may call J hn P. Roberts at (301) 492-0608, or write

1. Veterans Administration Medical Center, to him at:

Buffalo, New York Supplement IV, EA 88-115 U.S. Nuclear Regulatory Commission One White Flint North, MS 6 'rt-3 i A Notice of Violation was issued on May 26, Washington, DC 20555 I 1988, based on a radiation exposure to the left hand and to the skin on the back of the neck of a senior investigator from the State Univer. IRRADIATOR WORKSHOP sity of New York at Buffalo; performance of surveys at a frequency less than required; On May 24,25,1988 the U.S. Nuclear Regulatory Com-i mission (NRC) Region I and Region IV offices held a l transfer and use of materialin an unauthorized workshop for licensees'of large, megacycle irradiators in manner; administration of a dose of radioac.

tive materials to a patient without first assay. Arlington, Texas as part of an NRC effort to improve communications with the various categories of licensees.

ing the dose in the dose calibrator to confirm its contents; and failurc to wipe-test packages All NRC and agreement State licensees throughout the i

of technetium-99m. A civil penalty was not pro. country were invited. Approximately one-hundred peo-I

' ple attended the workshop, posed, because the licensee promptly identified and reported the overexposure, as well as tak-ing prompt and extensive corrective actions.

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During the two-day conference, spe kers r: presenting RULEMAKINGS PUBLISHED l

NRC, Agreement States, irradiator licensees, and ir- April 1-July 31,1988 radiator source and equipment suppliers exchanged in-formation on a large number of topics. These included incidents and other problems at irradiators; licensing and FINAL RULES l inspection experience; historical trends in the use of ir- .

radiators; upcoming regulatory developments; need for * " Minor Corrective Amendments" an improved database; possible formation of an industry 1. Published: 5/18/88

2. For information, contact: Donm,e Gn,msley (301) group; relationships of irradiators with local zoning or-dinances; the continuing concern about soluble cesium 492-7211 sources; automatic safety system design; human factors . " Addresses for Personal Delivery of Communications" aspects; and accountability and inventory of sources. 1. Published: 5/19/88

2. For information, contact: Donnie Grimsley (301)*

The workshop attendees agreed that this forum offered 492-7211 an excellent opportunity for a better understanding of the issues mvolved in the operation of large irradiators. * " Diagnostic Misadministration Report Form"

1. Published: 6/9/88

2. For information, contact: James Myers (301)

Send us your 35 to 50 word good news fact or figure 492-0635 and we'll spread the word! * " Access Authorization Fee Schedule for Licensee Personnel"

1. Published: 6/13/88 REPORT OF RADIATION ACCIDENT IN 2. For information, contact: Duane Kidd (301)

GOIANIA, BRAZIL 492-4124 The International Atomic Energy Agency (IAEA) has . " General Requirements for Decommissioning Nuclear published a report that describes, in detail, the radiation Facilities" accident in Goiania. This accident involved the abandon

• 1. Published: 6/27/88 ment of a 1200-curie cesium-137 teletherapy device at a 2. For information, contact: Dan Martin (301) therapy clinic and its subsequent transport to a junk yard. 492-0557 There, it was broken open and caused serious radiation overexposure to about 120 people and radiation-induced " Control of Aerosols and Gases" deiths to 4 individuals. The report also describes the 1. Published: 7/22/88 follow-up actions that health and safety agencies took, 2. For information, contact: James Myers (301) including monitoring the public; treating radiation in- 492-0635 juries; surveying the town of Goiania; and cleanup of the extensive contamination of junkyards., homes, and other PROPOSED RULES public areas. The incident stemmed from the clinic * " Disposal of Radioactive Wastes" owner's failure to control and account for the device. For 1. Published: 5/18/88 this reason.,this report should be ofinteres,t to licen, sees 2. For information, contact: Daniel Fehringer (301) possessing sigmficant quantitles of radioactive matenals, 492-0246 as an cxtreme example of what could happen if such

• " Transportation Regulations: Compatibility with the materials are not properly controlled and accounted for. International Atomic Energy Agency"

1. Published: 6/8/88 The report is I AEA Report STI/ PUB /815 and is available 2. For information, contact: Donald Hopkins (301) in the United States from the IAEA distribut,on i center, 492-3784 at the following address:

ADVANCE NOTICE OF PROPOSED RULEMAKING UNIPUB 4611 F Assembly Drive * " Regulation of Uranium Enrichment Facilities" Lcnham, MD 20706 1. Published: 4/22/88

2. For information, contact: Leland Rouse (301) 492-3328 ERRATUM NRC distributes rules to affected licensees and other in-A typographical error changing the meaning of a terested persons when they are published. Rules are statement appeared in the June 1988 NMSS available for inspection and copying at the Commission's Licensec Newsletter (NUREG/BR-Oll7, No. 88-2). Public Document Room at 1717 H St., N.W.,

On page 4,2nd column, paragraph under Event-7, Washington, D.C. and at local public document rooms beginning of line 13, "530 mci" should be "530 and depository libraries around the country. They are also pCi ." available in the issues of the Federal Register, for the i dates cited.

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REGULATORY GUIDE ISSUED IN FINAL FORM The incident occurred during the treatment of an outpa-April 1-July 31,1988 tient. The hospital reported that after three attempts to load the source into the patient (device malfunction), the e 8.32. " Criteria for Establishing a Tritium Bioassay staff took the patient from the shielded room, removed Program" the catheters, and conducted surveys of the patient and

1. Published: 7/13/88 the relevant materials. Although staff measured relatively

2. For information, contact: Barbara Brooks (301) high radiation levels near the device, it found neither con-492-3738 tamination nor radiation present either in or on the pa-tient or areas outside the treatment room.

Regulatory Guides are available for inspection and copy-ing at the Commission's Public Document Room at 1717 The Nucletron Corporation's radiation safety officer H St., N.W., Washington, D.C. 20555 and at local public (RSO) responded to the incident. His dosimeter went off document rooms and depository libraries around the scale after three to five minutes in the treatment room.

country. The hospital's panoramic survey meter read 800 millirem per hour near the device. The RSO entered the treatment Copies of issued guides may be purchased from the room a second time, under Alabama Radiation Control Government Printing Office (GPO) at the current GPO Program guidance; this time, he learned that all source price. Information on current GPO prices may be ob- wafers were contained within the device. At this time, he tained by contacting the Superintendent of Documents, received additional exposure of 60 millirem, with his total USGPO, P.O. Box 37082, Washington, D.C. 20013-7082 exposure calculated at approximately 360 millirem.

or calling (202) 275-2060 or (202) 275-2171. Future guides in various divisions may also be purchased by subscrip- The Alabama Radiological Health Branch, responding tion from the GPO. immediately to the incident, performed confirmatory surveys outside the treatment room and determined that REGULATORY GUIDES ISSUED IN DRAFT FORM the hospital's survey equipment was operating properly.

April 1 July 31,1988 NRC is providing regulatory oversight and guidance to both the hospital and the Nucletron Corporation representative. The Alabama Radiological Health Branch

• 8.12, " Criticality Accident Alarm Systems" has briefed the State's Health Department management

1. Published: 5/11/88 on the incident.

2. For information, contact: Keith Steyer (301) 492-3824 Preliminary results of the joint investigation that the State

• 3.45," Nuclear Criticality Safety for Steel Pipe Intersec- of Alabama and Mallinkrodt conducted indicated that tions Containing Aqueous Solutions of Fissile an end cap came off, thereby releasing the contents of Materials" the source within the device, investigators did not detect

1. Published: 5/31/88 contamination on the externals of the device or in the

2. For information, contact: Keith Steyer (301) treatment room. On August 12,1988, the RSO sent the 492-3824 device to Mallinkrodt, for further evaluation.

NUREG DOCUMENT ISSUED Nucletron notified all device users about the incident, in an August U, W88 ktten in aWon, h noN users

• 0713 " Occupational Radiation Exposure at Nuclear Reactors and Other Facilities" Qa recsed M somm th same wed as h vidence Hospital about the event and to!d them that it For i f ation, contact: Barbara Brooks (301) had mded reNacement sourm fm mem.

492-3738 INCIDENT AT PROVIDENCE HOSPITAL I MOBILE, ALABAMA Comments and suggestions you may have on infor- '

mation that would be helpful to licensees should be Alabama, an Agreement State, notified the U.S. Nuclear sent to:

Regulatory Commission (NRC) on August 10,1988,of E. Kraus an incident at, Providence Hospital, in Mobile, Alabama. NMSS Licensee Newsletter Editor The meident myolved high radiation levels from a remote Office of Nuclear Material Safety and after-loading device containing a five-curie iridium-192 Safeguards sealed source, which is used to treat cancer. Nucleotron (One White Flint North, Mail Stop 6-A-4)

Engmeeting, m Petten, Holland, manufactures the U.S. Nuclear Regulatory Commission device; Mallinkrodt, in St. Loms, MO, manufactures Washington, DC 20555 the source for it; and Nucleotron Corporation, m Co-i lumbia, Maryland, distributes the device.

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N INFORMATION NOTICES PUBLISHED parts of the body, mislabeling can cause un-MAY-AUGUST 1988 necessary radiation exposure to a part of body other than intended, as well as failure to produce A. Prompt Reporting to NRC of Significant Incidents the needed diagnostic information.

Involving Radioactive Material-IN No. 88-32, Dated May 25,1988. 2. NRC enforcement policy provides that failure to

1. This Notice informed licensees that they should [ep rt diagnostic misadmin..trations will result in Severity Level I\ violations. Seventy Level V report significant events to the U.S. Nuclear vi lations are reserved for violations of minor Regulatory Commission (NRC), promptly, as re-safety significance. However, for repetitive viola-quired by 10 CFR Section 20.402, " Reports of Theft or Loss of Licensed Material," and 10 CFR d "S . r multiple examples of violations, the Severity Level can be raised to Seventy Level 111.

Section 20.403, " Notifications of Incidents.,,

This can result in a civil penalty, which was the

2. One case illustrating lack of prompt reporting in- case f r the nuel, ear pharmacy referred to above.

Because a recipient of a mislabeled radiophar-volved a contamination incident at Wright- maceutical of the wrong chemical form cannot Patterson Air Force Base in Ohio. Radiation workers in a radioactive waste storage building '.asily detect the chemical form, the NRC is con-sidering modifying its enforcement policy to opened a package containing americium-241, and re et a uw category of violations m this area, inadvertently spread contamination within the building. When the licensee's workers began C. Recent Findings Concerning Implementation of decontamination efforts, the contammation Quality Assurance Programs by Suppliers of spread got worse. The licensee did not report the Transport Packages-IN No. 88-62, Dated August event to NRC for eight days, and then did not 12' 1988' describe the extent of the contamination ade-quately. NRC did not learn of the full seriousness 1. This Notice informed licensees of the results of of this event until 27 days later, when third par- NRC inspections of the implementation of NRC-ties sent additional reports and NRC inspectors approved Quality Assurance (QA) programs, by went to the site. Clean-up efforts eventually re- persons who fabricate and supply transport quired several weeks of work and cost several packages to users. Inspections of suppliers of hundred thousand dollars. packages showed various degrees of failure to fulfill NRC-approved QA programs. In more

3. Other incidents that were not promptly reported serious cases of these failures, NRC withdrew the to NRC included a serious fire that damaged a QA program approvals. These withdrawal actions device containing radioactive material, and losses can seriously affect package supplier operations, of measuring gauges containing radioactive as well as package user operations.

material.

2. NRC-approved QA programs that apply to B. Licensee Violations of NRC Regulations, Which Led package users may only cover activities related to Medical Diagnostic Misadministration-IN 88-53, to procurement, maintenance, repair, and use.

Dated July 28, 1988. However, NRC recognizes that package suppliers perform other QA activities. These include

l. This Notice informed licensees of enforcement ac- design, fabrication, assembly, tests, and tion that NRC took against a nuclear pharmacy modifications that are required to be controlled l which mislabeled vials of radiopharmaceuticals under Subpart H of 10 CFR Part 71. In these lat- I on six separate occasions over a 16-month period, ter cases, package users should assure themselves The mislabeling of vials with the wrong chemical that these activities are performed in accordance forms caused misadministration at client with the package suppliers' NRC-approved QA hospitals. During an NRC inspection at the program, by obtaining certification from the nuclear pharmacy, it was found that the mis- package suppliers.

labeled drugs that were given to patients resulted in 14 misadministration. The hospitals reported 3. NRC regulations require holders of NRC-the misadministration to NRC, as required by approved QA programs to document the 10 CFR Part 35. In each case, the labels placed implementation of their programs through writ-on the vials of drugs showed the correct quantity ten procedures and instructions. The inade-  ;

(activity) of material, but the incorrect chemical quacies of those programs appear to result f;om form. Once this error had been made, the re- lack of adherence to these requirements NRC cipient hospital had no way to verify the chemical nspections identified cases of inadequate docu-form of the radiopharmaceutical; the nuclear mentation in all areas of the QA programs.

pharmacy, however, correctly verified the activi- Some examples of QA program requirements ty. Because different chemical forms are used to that licensees inadequately complied with are:

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(a) Independence of personnel who verify that investigated possible wrong-doing. The inspec- l l

l. activities are performed correctly tion and investigation revealed numerous in- 1 I

stances where licensee personnel had concealed (b) Qualifications of personnel who perform special processes such as welding radiographic exposure devices containing radioactive sources, so as to transport them on l (c) Assurance that procurement documents civilian and military flights. Those con-  !

contam the applicable requirements of Sub- cealments, which violated NRC and Department part H of 10 CFR Part 71 and 10 CFR Part of Transportation (DOT) regulations, apparent-21 ly were to avoid the inconvenience of using (d) Corrective action systems proper shipping devices, as required. During the inspection, several other violations also were (e) Training and indoctrinathn of personnel found: (1) failure to survey exposure devices to performing activities affecting quality ascertain that radiation levels were within limits; (f) Control of documents, including review aP- (2) individuals acting as radiographer and proval by authorized personnel radiographer' assistants without proper train-(g) Assurance that sufficient records are ing; (3) radiation safety violations in posting of available to furnish evidence of activities af- radiation areas, providing surveillance in fecting quality restricted areas, and locking of exposure devices; (4) use of partially discharged (h) Performance of audits, and qualifications docimeters; and (5) failure to mamtam required of auditors records. As a result of the above findings, NRC suspended the company's license and issued an D. Industrial Radiography Inspection and Enforce- rder to show cause why it should not revoke ment-IN No. 88-66, Dated August 22,1988. ,

the license. NRC referred the case to the U.S. J

1. This Notice informed radiography licensees of Department of Justice, for investigation of l

the importance of complying with No.C regula- possible wrong-doing. i tions in all aspects of industrial radiography. In August 1987, NRC received allegations that a 2. The Notice emphasized that NRC will not ex-radiography licensee in Hawaii was transporting cuse licensee employee violations because radiographic exposure devices (containing sealed management was unaware of the violations or sources) improperly, on passenger-carrying air- because employees were not trained in ap-craft. The NRC Regional Office conducted an plicable regulatory requirements.

inspection, and the Office of Investigations (01)

UNITED STATES n,,, et,,, ,,g NUCLEAR REGULATORY COMMISSION Postaas ie ress paio

"* " I WASHINGTON, D.C. 20555 PsRMIT fuo. o 57 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE. 8300 l

1 8

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