ML20129G384

Insp Repts 99990002/96-03 & 99990002/96-04 on 960726 & 29. Violations Noted.Major Areas Inspected:Review of Control & Conduct of Licensed Activities at Diagnostic Photon Corp Radiopharmacy in Carolina,Puerto Rico

ML20129G384
Person / Time
Issue date:	09/20/1996
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20129G362	List: ML20129G355 ML20129G384
References
REF-QA-99990002-960920 99990002-96-03, 99990002-96-04, 99990002-96-3, 99990002-96-4, NUDOCS 9610030038
Download: ML20129G384 (18)

Text

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i U. S. NUCLEAR REGULATORY COMMISSION REGION II Docket Nos.

030 19134. 999 90002 and 999 90002 License No.: 52 16345 02MD Report Nos.: 52 16345-02MD/96 01. 999 90002/96-03 and 999-90002/96-04 i

Licensee: Diagnostic Photon Corporation Other Entities: Syncor Overseas. Ltd. and Syncor International Corporation Location: Carolina. Puerto Rico Dates: July 26 and 29, 1996, onsite  !

I Inspector: H6ctor Bermodez. Senior Radiation Specialist l Approved by: John P. Potter Chief Materials Licensing / Inspection Branch 2 Division of Nuclear Materials Safety Enclosure 1 9610030038 960920 REG 2 GA999 ENVSYNCO >

99990002 PDR A

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EXECUTIVE

SUMMARY

Diagnostic Photon Corporation, Syncor Overseas. Ltd. and Syncor International Corporation NRC Inspection Report Nos. 52 19134 02MD/96 01. 999 90002/96 03 and 999 90002/96 04 i i This special, announced inspection was conducted to review the control and  ;

conduct of licensed activities at the Diagnostic Photon Corporation's (DPC's)  ;

radiopharmacy located in Carolina. Puerto Rico. This included a review of the l licensed radiation safety program. The inspection was conducted because the l President of DPC had reported on June 28 and July 3.1996, that Syncor International Corporation (SIC) had taken control of licensed activities. The ins wetion included direct observation of activities in progress, discussions  :

i wit 1 cognizant DPC and Syncor Overseas Ltd. (SOL) representatives, review of I

documents, and review of the organization and scope of the DPC's program. l Within the scope of the inspection, six apparent violations of NRC requirements were identified. The apparent violations involved

(1) the apparent transfer of control of licensed activities on the part of DPC without prior NRC consent. (2) the apparent failure of SIC to obtain a valid NRC license prior to possessing, using and distributing byproduct materials in Puerto Rico, (3) the apparent failure of SOL to obtain a valid NRC license prior to possessing, using and distributing byproduct materials in Puerto Rico, (4) the failure of DPC to notify NRC of the credentials of appointed Authorized Nuclear Pharmacists within 30 days of their beginning work, (5) the i failure of DPC to train personnel on the requirements of its operating and

, emergency procedures and license, and (6) the use by DPC of unauthorized l

operating procedures. l

. LIST OF PERSONS CONTACTED i

t Licensee

• J. Caama50. H.D., President and Radiation Safety Officer 1 N. Oldham, Alternate Radiation Safety Officer  !

• A. Gonz&lez G61 gel . Esq., Licensee's Counsel Syncor Overseas. Ltd.

R. Green Pharmacist

1. F. Pena, Office Manager

1. J. Simon, Pharmacist ,

Syncor International Corooration

1. F. PeMa, Office Manager

1. J. Simon, Pharmacist

• By telephone during both the inspection and exit interview

1. Represented both Syncor International Corporation and Syncor Overseas. Ltd.

during the exit interview with SOL on July 29, 1996 4

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. . j REPORT DETAILS 1

1. Backaround I

License No. 52-16345-02MD was originally issued to DPC on July 27, 1983, and was most recently amended on April 18, 1995. As a result of ]

rulemaking, on March 1, 1996, the license's expiration date was extended to April 30, 2005. The license authorizes the possession and use of byproduct materials for the preparation and distribution of radioactive drugs (radiopharmaceuticals) to authorized recipients in accordance with conditions specified therein. The license also authorizes the preparation and distribution to authorized recipients of therapeutic iodine 131 radiopharmaceuticals but such activities have never been conducted at the licensee's facility (pharmacy).

On February 6, 1996, DPC entered into a Management Agreement (Agreement) with SIC which was effective on March 1, 1996. The Agreement specified that SIC would have control over the management and operation of the DPC pharmacy and SIC's use of DPC's licenses. The Agreement also committed DPC's management to promptly sign applications for any and all of its licenses, and allowed SIC to make all decisions related to the pharmacy and to conduct all affairs as SIC deems appropriate. In addition, the Agreement specified that DPC's President, who is the designated  !

Radiation Safety Officer (RS0) on the NRC license, was to be retained as I a consultant and that all other DPC employees, including the Alternate l RSO designated on the NRC license, were to become employees of SIC.

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2. Circumstances Leadina to the Insoection  ;

l In early March 1996. DPC's President advised the NRC that he had i recently allowed SIC to manage his pharmacy pending a potential transfer i of the business and all applicable federal and local permits. He requested an inspection at that time to make sure SIC was properly conducting licensed activities under his license. After discussions with the inspector, it was determined that, due to the short time that SIC had been involved in DPC's operation and the lack of negative  ;

safety significant information available, an inspection was not l warranted at that time. DPC's President was informed that NRC believed it would be 3rudent to delay any inspection for approximately three l months and tlat it was importent that he carefully monitor the transition in operations.

On March 25, 1996. DPC requested an amendment to its license. The I letter referenced the Agreement and mentioned a pending transfer of the license to SIC. On June 14, 1996. SIC personnel replied to questions raised by the NRC in a May 15, 1996 letter regarding the requested amendment. The reply addressed, among others, the use of new labels and transport containers and a bioassay program related to the intended use of iodine 131. The reply further stated "We are aware that changes requested may not be implemented until final approval is received from your agency." The letter indicated a place for signature, but was not signed by the President of DPC. NRC replied to SIC's June 14, 1996

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letter by indicating that its letter seeking a license amendment must be signed by the President of DPC in order for NRC to continue its review of the amendment request. On June 28, 1996, DPC's President indicated during a telephone conversation with NRC that he had not signed the letter because he was not sure that iodine 131 could be handled safely at his facility, During the same June 28, 1996 conversation, the NRC inquired about the status of DPC operations to determine whether an insaection was warranted at that time. DPC's President indicated tlat: (1) he had lost control over licensed activities, (2) he did not like the way in which activities were being conducted at his facility, and there was little he could do to rectify the situation, (3) there was too much turnover of' dispensing pharmacists and their credentials were unknown to him, and (4) he wished that NRC inspect his facility as soon as possible. The NRC then spoke with SIC's lead representative on site, who faxed Region II a co)y of the Agreement. The SIC representative indicated that he used t1e Agreement as his basis for justifying his actions involving his control over the pharmacy. The SIC representative ,

indicated that such actions included the implementation of the  !

NRC licensed program. i On July 3,1996, NRC, Region II, after legal and technical review of the Agreement, telephoned DPC's President and informed him that it appeared that, since March 1, 1996. DPC had been in violation of 10 CFR 30.34(b),

which prohibits the transfer of control of an NRC license without prior ,

NRC consent. The President was informed that if neither he, as the RSO, l nor the Alternate RS0 designated on the license, were in control of l licensed activities, there was no valid license under which SIC was operating. The President indicated that he would try to regain control 4

of licensed activities at his facility.

On July 16, 1996, SIC assigned its interest in the Agreement to Syncor Overseas Ltd. (SOL), Citco Building Wickhams Cay, P.O. Box 662. Road i Town. Tortola, British Virgin Islands. On July 19, 1996, SOL, requested .

NRC to transfer DPC's NRC license to their name and that a new RSO be l

) named. NRC's response to this request is discussed in Section 4 of this ,

report. <

On July 22, 1996, DPC's Altern;*a RS0 was escorted out of the facility l by SOL 3ersonnel with instructions that she not return to the facility.

On or a)out the same date, SOL personnel changed the locks of all entrance doors to the facility and did not provide keys to DPC's

, President. Since then. DPC's President /RS0 has not had keys to the facility and the Alternate RS0 named on the license has been prohibited from entering the building.

The inspector conducted an onsite inspection on July 26 and 29, 1996.

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3. Insoection Results 3.1 Observations and Findinas Recardina OPC 3.1.1 Control of Licensed Activities 10 CFR 30.34(b) provides that no license issued by the Commission, nor any right under a license, be transferred, either voluntarily or involuntarily, directly or indirectly, through the transfer of control of a license to any person unless the Commission, after securing full information, finds that the transfer is in accordance with the provisions of the Atomic Energy Act and gives its consent in writing.

As part of the inspector's attempt to ascertain who was in control of licensed activities, the inspector determined the following:

a. From review of records and discussions with SOL representatives, between March 1 and July 16, 1996, J ; between July 16 and July 29, 1996, SIC and 50L, respectively. : otated pharmacists who aracticed at various SIC pharmacies iocated on the mainland into JPC at a frequency of approximately once every two weeks. During telephone discussions with DPC's President, the President indicated he continued to be unable to ascertain the qualifications of the pharmacists who were dispensing at his facility because he did not want to create conflicts. The inspector indicated that it was his responsibility to ascertain the qualifications of the pharmacists and the President indicated he would try to do so. SQL representatives stated that it was SIC and SOL who designated the nuclear pharmacists during their respective periods of operation, not DPC.

b. The pharmacist representing SOL the weeks of July 15 and 22,1996, stated to the inspector on July 26, 1996, that he used SIC's Operations Manual for the conduct of licensed activities and that he had not received training on DPC's o)erating and emergency procedures. The pharmacist indicated t1at he felt comfortable that SIC's manual would be at least as thorough as DPC's. While inspecting DPC's packaging, container labels and unit dose containers, the inspector noted that they were not the ones routinely used by DPC but were the ones seen by the inspector to be routinely used at other SIC facilities in the mainland. The inspector also noted that the transport containers and labels in use were the ones for which approval was sought in the June 14, 1996 letter, which is the same letter to which the President of DPC objected because it included references to the use of iodine 131. These issues are discussed further in Section 3.1.3 below.

c. The language in the Agreement assigned SIC to make all decisions related to the pharmacy and conduct all affairs as SIC deems appropriate. Also, SIC would have control over the management and operation of the DPC pharmacy and SIC's use of DPC's license.

4 This authority was transferred to SOL by SIC on July 16, 1996 without DPC consent. Neither of these assignments of control were consented by the NRC.

d. The DPC RSO and Alternate RSO were restricted from access to the pharmacy. Through discussions with the DPC RSO, Alternate RSO and '

SOL representatives, the inspector determined that the Alternate l RS0 was escorted from the facility on July 22 by SOL staff. This I action was related to a purchase and gift transfer of thallium 201, a transaction that SOL considered contrary to another agreement between DPC and SIC. 50L representatives stated  !

that the alleged inaparopriate transfer of thallium 201 was the l reason for changing t1e locks to the facility. An 50L representative indicated that, if and when DPC's President / RSO wishes to access the facility to supervise licensed activities as required by his function as RSO, he must be allowed in by SOL personnel without restriction but SOL personnel must be onsite  ;

whenever the RSO is present. Through discussions with SOL  !

representatives, the inspector further learned that, during June and July 1996, DPC's RS0 seldom frequented the facility to supervise licensed activities. DPC's President stated to the inspector that his lack of attendance was due to his intention to avoid conflicts.

e. As described further in Section 2 the SIC lead representative at the pharmacy, indicated, on June 28, 1996, that the Agreement allowed him to control the pharmacy. The representative indicated this included implementation of NRC-licensed activities.

Based on: (1) the language contained in the Agreement which addresses the transfer of control of the operation of the pharmacy and SIC's use of DPC's licenses, as summarized in Section 1 of this report, (2) the  !

President of DPC's statements during the June 28. and July 3 and 26, 1996 conversations regarding loss of control over licensed activities and his inability to ascertain the credentials of dispensing 3harmacists at his facility, (3) the fact that SIC and SOL dictated who t1e Authorized Nuclear Pharmacists (ANPs) would be, without any input from DPC management, (4) the fact that, at least during the weeks of July 15 and 22, 1996, it was SIC's operating and emergency procedures that were  !

being implemented, not DPC's (5) the fact that the pharmacist who worked during the weeks of July 15 and 22,1996 did not receive training on DPC's operating and emergency procedures or the license because it was his understanding that he was to operate under SIC's Operations Manual, (6) the fact that SIC and SOL representatives implemented I changes to the licensed program without DPC or NRC approval by changing l the labels and transport containers to conform with SIC's standard  !

operating practices (7) the SIC representative's understanding that the Agreement allowed him to control NRC licensed activities at the pharmacy. (8) the fact that the Alternate RSO was prohibited by SOL from entering the pharmacy (9) the fact that DPC's President and RSO has been denied the keys the pharmacy, and (10) the lack of presence of the RSO during June and July 1996 to supervise licensed activities and his l

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5 reliance on SIC and SOL pharmacists, whose credentials are unknown to him, to supervise the licensed program. the inspector concluded that an apparent transfer of control of the NRC license occurred without prior NRC consent.

1 The transfer of control of the NRC license without the NRC's prior l consent was identified as an apparent violation of ,

10 CFR 30.34(b).

3.1.2 Failure to Submit Credentials of ANPs 10 CFR 32.72(b)(5) requires that a licensee )rovide the Commission a copy of each individual's certification by t1e Board of Pharmaceutical Specialties, the Commission or Agreement State license and a copy of the 2

tate pharmacy licensure or registration, no later than 30 days after

. the date that the licensee allows the individual to work as an i Authorized Nuclear Pharmacist (ANP). j Through discussions with DPC and SOL re]resentatives and reviews of records, the inspector determined that Jetween March 1 and July 29.

1996. DPC allowed six individuals to practice as ANPs. As of the date of this report DPC has failed to submit to the NRC the credentials of all the individuals who had been allowed to work as ANPs within 30 days of their beginning work. SOL re)resentatives indicated that it was DPC's resaonsibility to submit t1e required credentials in a timely manner. )PC's President indicated he was unable to obtain them, and, therefore, he was unable to submit them. The inspector reminded DPC representatives that although control of the license may have transferred, such transfer had not been authorized by the NRC and, therefore. DPC remained the licensee. Based on this, the inspector indicated that DPC was required to comply with the reporting requirement. The failure to submit to the NRC the credentials of individuals designated as ANPs within 30 days of their designation as such was identified as an apparent violation of 10 CFR 32.72(b)(5).

3.1.3 Operatina and Emeroency Procedures and Personnel Trainina Condition 20 of License No. 52 16345 02MD requires that the licensee conduct its program in accordance with the statements and procedures contained in the licensee's application dated December 7,1988, and letters dated April 20, 1989, March 2, 1994, and April 5. 1995.

10 CFR 19.12 requires, in part, that individuals who in the course of  ;

employment are likely to receive in a year an occupational dose in excess of 100 millirems be instructed in the applicable provisions of Commission regulations and licenses.

As discussed in Section 3.1.1 above, the 3harmacist representing SOL the weeks of July 15 and 22, 1996 stated to t1e inspector on July 26, 1996, that he was operating under SIC's Operating Manual and showed the inspector a copy of the manual. The manual contained procedures and

6 instruction on how to carry out SIC's operations. The pharmacist also stated that the training program for all new personnel consisted of the standard SIC training manual and videotape. and that it did not include the provisions of DPC's operating and emergency procedures contained in DPC's license. The pharmacist further stated that he had not received training on the licensee's procedures and instructions contained in the licensee's application dated December 7, 1988, and letters dated April 20. 1989 March 2, 1994, and April 5. 1995. This became evident to the inspector when the inspector saw SOL staff supervised by the pharmacist using SIC's transport containers and labels and SOL's shipping papers. DPC's transport containers, labels and shipping papers are described in DPC's license application dated December 7, 1988.

The failure to conduct operations in accordance with the statements and procedures contained in the licensee's application dated December 7, 1988, and letters dated April 20, 1989. March 2, 1994, and April 5, 1995, during the weeks of July 15 and 22, 1996, was identified as an apparent violation of Condition No. 20 of License No. 52 16345 02MD. In addition. the failure of the licensee to train a sharmacist on the operating and emergency procedures contained in tie license was i identified as an apparent violation of 10 CFR 19.12.

3.2 Findinos Reaardina SIC and SOL 10 CFR 30.3 requires, with exemptions not applicable here, that no person manufacture, produce, transfer, receive, acquire, own, possess or use byproduct material except as authorized in a specific or general license issued pursuant to the regulations contained in Title 10 of the Code of Federal Regulations (10 CFR).

Based on the discussions in Section 3.1.1 above, the inspector concluded that between March 1 and July 16, 1996, and between July 16 and 29, 1996 SIC and S0L, respectively, conducted activities subject to NRC licensing without a valid NRC license. Specifically, in their respective timeframes, both SIC and 50L used licensed materials and controlled the use of the NRC license issued to DPC without consent of the NRC in violation of the transfer of control provisions specified in 10 CFR 30.34(b). Since the transfer was not aaproved by the NRC and there was no other license issued to SIC or 50. for use of byproduct materials at the pharmacy, the conduct of activities subject to licensing without a valid NRC license was identified as an apparent violation of 10 CFR 30.3. 3

4. Developments Subseauent to the Insoection In response to the NRC onsite inspection findings. a Confirmatory Action Letter (CAL) was issued to SOL on July 29, 1996, confirming SOL's agreement that DPC be in control of the license and that activities be conducted in accordance with DPC's approved radiation safety program.  !

On August 19. 1996, the SOL President, responded to the CAL in writing j to the NRC. The letter described restrictions to the DPC RSO on access 4 to the facility. However, it indicated the RSO and DPC held l l

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responsibility and control for the license. The letter informed the NRC l that SOL operations in Puerto Rico were being conducted under DPC's license and that DPC's President was afforded all necessary access to the facility to supervise licensed activities as RSO. The NRC determined the access described in the letter allowed adequate control of the DPC license to comply with 10 CFR 30.34, if implemented as j i described.  ;

On August 8,1996, the NRC replied to SOL's July 19, 1996 request to transfer DPC's license to their name and to change the RSO. The NRC reply indicated that SOL's request of July 19, 1996 could not be approved because it was not signed by the licensee or a person duly authorized to act on behalf of the licensee.

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On July 29, 1996, the NRC wrote a letter to DPC discussing the

, inspection findings and an apparent violation of 10 CFR 30.34(b). The letter indicated that DPC must maintain control of its NRC licensed activities and provided the results of the July 29 CAL with SOL / SIC.

On August 5, 1995. DPC's counsel informed NRC that SOL continued to hinder the DPC RSO from effectively controlling operations conducted under the license without specific examples. NRC replied on August 19, ,

1996, and requested specific examples.

On August 27, 1996, DPC's President advised NRC that he had recently .

learned of SOL's July 19, 1996 letter requesting transfer of his  :

license. DPC's President indicated that the NRC staff should disregard such letter since he did not want the transfer of the license to occur or the change in RSO to be made. He also expressed concern that SIC /S0L

personnel had been communicating issues directly to NRC relevant to his license without his knowledge. On September 3, 1996, DPC's counsel i addressed, in writing, the possibility of litigation with SIC and rescission of the Agreement and other contracts for, among others, the alleged " continued failure to ... cooperate with the transfer of licenses."

On September 12, 1996, SOL applied for a separate license to operate at DPC's facility. On September 18, 1996. SIC /S0L representatives were told by Region II that the license application will be submitted to the NRC Headquarters in Washington, D.C., to evaluate the implications of

' licensing two separate entities to operate in the same facility.

5. Exit Meetina Summary An exit interview was held separately with DPC and S0L representatives at the conclusion of the onsite inspection on July 29, 1996. The overall findings from the inspection, including the apparent violations '

were discussed. No dissenting comments regarding the transfer of control of the license were received from DPC. An additional exit interview via telephone was conducted with DPC's President on September 16, 1996, in which additional apparent violations were discussed as a result of further review of this case. Regarding the rest of the apparent violations DPC's President took exception

8 discussing his lack of control of licensed activities as specified in Section 3.1.2 above.

The lead SOL representative onsite on July 29, 1996, took exception to the inspection findings involving SIC and 50L. The SOL representative indicated that, if DPC were not in control of licensed activities SOL would have proceeded with activities they desired to conduct that DPC's President did not want to conduct. The SOL representative indicated that such activities included compounding and distributing therapeutic dosages of iodine 131. Based on this, the lead 50L representative onsite contended that a transfer of control over the license had not occurred, and therefore SIC operated and SOL had been operating under a valid license DPC's, all along. Regarding the activities that SOL wanted to conduct against the wishes of DPC's President, the inspector noted that SIC /S0L requested NRC to amend the DPC license to allow the changes without consent of DPC. The inspector further indicated that the preponderance of the evidence, the facts as understood by the inspector and the conduct of the parties involved led to the inspector's conclusion that a transfer of control of the NRC license had taken place without NRC's consent.

Proprietary information was reviewed as part of the inspection but is not contained in this report.

ITEMS OPENED AND DISCUSSED OPENED 96001 01 VIO UNAUTHORIZED TRANSFER OF CONTROL OF AN NRC LICENSE 96001 02 VIO FAILURE TO SUBMIT CREDENTIALS OF ANPs WITHIN 30 DAYS OF BEGINNING 0F WORK 96001 03 VIO FAILURE TO INSTRUCT PERSONNEL ON THE REQUIREMENTS OF THE LICENSEE *S LICENSE AND l OPERATING AND EMERGENCY PROCEDURES 96001 04 VIO USE OF UNAUTHORIZED OPERATING PROCEDURES 999 90002/96003 01 VIO SOL OPERATING WITHOUT A VALID NRC LICENSE 4

999 90002/96004 01 VIO SIC OPERATING WITHOUT A VALID NRC LICENSE

UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

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WASHINGTON. D.C. 20555 May 1. 1996 NRC'INFORMATION NOTICE 96-28: SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION Addressees All material and fuel cycle licensees.

Puroose The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to provide addressees with guidance relating to development and implementation of corrective actions that should be considered after identification of violation (s) of NRC requirements. It is expected that recipients will review this information for applicability to their facilities and consider actions. as a)propriate. to avoid similar problems. However, suggestions contained in t11s information notice are not new NRC requirements:

therefore, no specific action nor written response is required.

Backaround On June 30, 1995. NRC revised its Enforcement Policy (NUREG-1600)1 60 FR 34381, to clarify the enforcement program's focus by, in part, em)hasizing the importance of identifying problems before events occur and of tacing prompt.

comprehensive corrective action when problems are identified. Consistent with the revised Enforcement Policy. NRC encourages and expects identification and prompt. comprehensive correction of violations.

In many cases, licensees who identify and promptly correct non-recurring Severity Level IV violations, without NRC involvement, will not be subject to formal enforcement action. Such violations will be characterized as "non-cited" violations as provided in Section VII.B.1 of the Enforcement Policy.

Minor violations are not subject to formal enforcement action. Nevertheless.

the root cause(s) of minor violations must be identified and appropriate corrective action must be taken to prevent recurrence.

If violations of more than a minor concern are identified by the NRC during an inspection. licensees will be subject to a Notice of Violation-and may need to provide a written response, as required by 10 CFR 2.201, addressing the causes of the violations and corrective actions taken to prevent recurrence. In some cases, such violations are documented on Form 591 (for materials licensees)

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9664290193 2

Copies of NUREG-1600 can be obtained by calling the contacts listed at the end of the Information Notice.

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I IN 95-28 May 1, 1995 Page 2 of 6 -

which constitutes a notice of violation that requires corrective action but ,

does not require a written response. If a significant violation is involved. i a predecisional enforcement conference may be held to discuss those actions.  !

The quality of a licensee's root cause analysis and plans for corrective actions may affect the NRC's decision regarding both the need to hold a predecisional enforcement conference with the licensee and the level of sanction proposed or imposed.

Discussion , l Comprehensive corrective action is required for all violations. In most  !

cases, NRC does not propose im]osition of a civil penalty where the licensee  ;

promptly identifies and compre1ensively corrects violations. However, a Severity Level III violation will almost always result in a civil penalty if a licensee does not take prompt and comprehensive corrective actions to address the violation.

'It is important for licensees, upon identification of a violation. to take the necessary corrective action to address the noncompliant condition and to 3revent recurrence of the violation and the occurrence of similar violations.

Prompt comarehensive action to improve safety is not only in the public  :

interest aut is also in the interest of licensees and their employees. In addition. it will lessen the likelihood of receiving a civil penalty. Compre-hensive corrective action cannot be developed without a full understanding of the root causes of the violation.

Therefore to assist licensees the NRC staff has prepared the following  !

guidance, that may be used for developing and imalementing corrective action.

Corrective action should be appropriately compre1ensive to not only prevent recurrence of the violation at issue. but also to prevent occurrence of ,

similar violations. The guidance should help in focusing corrective actions j broadly to the general area of concern rather than narrowly to the specific violations. The actions that need to be taken are dependent on the facts and circumstances of the particular case.

The corrective action process should involve the following three steps:

1. Conduct a comolete and thorouah review of the circumstances that led to j the violation. Typically, such reviews include: l

. Interviews with individuals who are either directly or indirectly involved in the violation, including management personnel and those responsible for training or 3rocedure development / guidance.

Par'icular attention should Je paid to lines of communication betwean supervisors and workers.

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1N 96-20 i May 1. 1996 i Page 3 of 6

. Tours and observations of the area where the violation occurred, particularly when those reviewing the incident do not have day-to-day contact with the o)eration under review. During the tour.

individuals should 100( for items that may have contributed to the violation as well as those items that may result in future violations. Reenactments (without use of radiation sources, if they  !

were involved in the original incident) may be warranted to better understand what actually occurred.

. Review of programs, procedures, audits. and records that relate directly or indirectly to the violation. The progre' should be reviewed to ensure that its overall objectives and rquirements are clearly stated and implemented. Procedures should be reviewed to determine whether they are com)lete, logical, understandable, and meet their objectives (i.e.. t1ey should ensure compliance with the current requirements). Records should be reviewed to determine l whether there is sufficient documentation of necessary tasks to i provide an auditable record and to determine whether similar violations have occurred previously. Particular attention should be paid to training and qualification records of individuals involved >

with the violation. L

2. Identify the root cause of the violation.

Corrective action is not comprehensive unless it addresses the root cause(s) of the violation. It is essential. therefore, that the root cause(s) of a violation be identified so that appropriate action can be taken to prevent further noncompliance in this area, as well as other potentially affected areas. Violations typically have direct and indirect cause(s). As each cause is identified, ask what other factors  ;

could have contributed to the cause. When it is no longer possible to '

i identify other contributing factors. the root causes probably have been identi fied. For example the direct cause of a violation may be a failure to follow procedures; the indirect causes may be inadequate i training. lack of attention to detail, and inadequate time to carry out l an activity. These factors may have been caused by a lack of staff  !

resources that, in turn, are indicative of lack of management support.

Each of these factors must be addressed before corrective action is considered to be comprehensive.

IN 96-28 May 1. 1996 i

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3. Take oromot and comorehensive corrective action that will address the '

immediate concerns and orevent recurrence of the violation, It is important to take immediate corrective action to address the specific findings of the violation. For example, if the violation was issued because radioactive material was found in an unrestricted area.

mmediate corrective action must be taken to place the material under

'icensee control in authorized locations. After the immediate safety concerns have been. addressed, timely action must be taken to prevent future recurrence of the violation. Corrective action is sufficiently comprehensive when corrective action is broad enough to reasonably prevent recurrence of the specific violation as well as prevent similar violations.

In evaluating the root causes of a violation and developing effective corrective action consider the following:

1. Has management been informed of the violation (s)?

2. Have the programmatic implications of the cited violation (s) and the potential presence of similar weaknesses in other program areas been considered in formulating corrective actions so that both areas are  ;

adequately addressed?

3. Have precursor events been considered and factored into the corrective actions?

4. In the event of loss of radioactive material, should security of radioactive material be enhanced?

5. Has your staff been adequately trained on the applicable requirements?

6. Should personnel be re-tested to determine whether re-training should be emphasized for a given area? Is testing adequate to ensure understanding of requirements and procedures?

7. Has your staff been notified of the violation and of the applicable corrective action?

8. Are audits sufficiently detailed and frequently performed? Should the frequency of periodic audits be increased?

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IN 96-28 May 1. 1996 Page 5 of 6

9. Is there a need for retaining an independent technical consultant to audit the area of concern or revise your procedures?

10. Are the procedures ~ consistent with current NRC requirements, should they be clarified, or should new procedures be developed?

11. Is a system in place for keeping abreast of new or modified NRC requirements?

12. Does your staff apireciate the need to consider safety in approaching ,

daily assignments?

13. Are resources adequate to perform and maintain control over, the licensed activities? Has the radiation safety officer been provided sufficient time and resources to perform his or her oversight duties?

'14. Have work hours affected the employees' ability to safely perform the job?

, 15. Should organizational changes be made (e.g., changing the reporting l relationship of the radiation safety of'icer to provide increased i independence)?

16. Are management and the radiation safety officer adequately involved in oversight and implementation of the licensed activities? Do supervisors i adequately observe new employees and difficult, unique, or new operations?

17. Has management established a work environment that encourages employees to raise safety and compliance concerns?

i 18. Has management placed a premium on production over compliance and safety? Does management demonstrate a commitment to compliance and -

safety?  :

l

19. Has management communicated its expectations for safety and compliance?

20. Is there a published discipline policy for safety violations, and are employees aware of it? Is it being followed?

s a

1N 96-28 May f. 199B '

Page 6 of 6 ,

This information notice requires no specific action nor written response. If you have any questions about the information in this notice, please contact one of the technical contacts listed below, signed.by signed by Elizabeth 0. Ten Eyck. Director Donald A. Cool. Director Division of Fuel Cycle Sa,fety Division of Industrial and Safeguards and Medical Safety Office of Nuclear Material Safety Office of Nuclear Material Safety and Safeguards and Safeguards Technical contacts: Nader L. Mamish. OE Daniel J. Holody. RI (301) 415-2740 (610) 337-5312 Internet:nlm@nrc. gov Internet:djh@nrc. gov Bruno Uryc Jr. RII Bruce L. Burgess. RIII (404) 331-5505 (708) 829-9666 Internet:bxu@nrc. gov Internet:blb@nrc. gov Gary F. Sanborn. RIV ,

(817) 860-8222 Internet:gfs@nrc. gov Atta:nments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices i

)

1 l

i I

1 34388 Fedesel Register / Val 60. N2.128 / Friday, June 30, teos / Notices i

s factors inlevel arriving is not held, the 1t=== will normally is a matter of senord,such as an severity win at bethe

_'_,a ppropriate

- - - on thebe. , M to provide a written -T' y by the d

cir===e==== of the violation. response to en ' ;- - Mon report,if N;- oflabor,in addition, with

! However, if a licensee refuses to correct issued, as to the le====='s views on the the approval of the Executive Dhector i a minor violation within a reasonable apparent violations and their root for Operatione, confuronome will not be time such that it willfully continues, the muses and a description of planned or open to the public where good asuas has violation should be categoriand at least . implemented corrective action. been shown aAerbalancingthe beneSt at a Severity involIV. During the pr=d==ta==l enforcement of the public observation against the p, yg,,, ,f fl* Porting .- r>-,,, conference,

- the licensee, vendor, or aber persons wiu be given an potentialimpact on the esency's enforcement acdon in a r-- ' case.

The NItC expects liconeses to provide opportunity to provide information As soon as it is deteruEned that a i complete. accurate, and timely consistant with the purpose of the -8='ence will be open-to public

{ information and reports. AccordinglY- en=8='ence, including ca explanation to observation, the NItC will notig the unless otherwise - . " in the b NRC of the i===< ato corrective Hama-that the comiennos win be Supplements, the severity level of a actions (if any) that were taken oPen to public observation as part of the violation involving the failure to make following ident18 cation of the potential agency's trial program #a==i=*==* with a required report to the NRC will be violation or naamniormance and the the agency's policy on open meetings, l based upon the signin~== of and the long-term comprehensive adions that " Staff Meetings Opa to Public,"

] circumstances surrounding the matter were taken or will be taken to prevent Published Sei 20,1994 (59 FR that should have been reported. recurrenos.1.i===== vendose, or ohr 4s340), the NRC intends to ===a===

However, the severity level of an persons will be told when a meeting is oPen conferences nonnauy at least to untimely report, in contrast to no spat

• a predecisional enforcement conference. working days in advance of ennh may be reduced depending on the A predecisional enforcement through (1) notices posted in the Public 4 circumstances a the matter. conference is a meeting between the Document Room. (2) a toll-free 3

A licenses will not y be cited for NRC and the licensee. Conferences are telePhone at 8064524674, j e failure to report a condition or event normally held in the regional ofBces and (3) a toll-free e bullarin i unless the 11=== was actually aware and are not normally open to public board at 8004524676. In addition, the l of the condition or event that it failed observation. However, a trial progrom is NRC will also issue a press rolesse sad to report. A licenses will, on the other being conducted to open approximately notify appropriate State liaison ofBcere hand, normally be cited for a failure to 25 percent of all eligible conferences for that a predecisional enforcement 1 5

report a condition or event if the public observation, i.e., every fourth "I='ence has been mandulad and that i

! licensee knew of the information to be eligible conference involving one of it is open to public observation. l j reported, but did not recognise that it three categories of licensees treactor, The public attending open was sequired to make a spwt. hospital, and other materials licensees) confomacos under the trial may V. Predecisional Enfersonnent will be open to the public. Conferences observe but not participate in Conferences will not normally be open to the public conference, it is noted that the purpose  !

I Whenever the NRC has learned of the if the enforcernent action being of conducting open confesences under b trial progma is not to ==vimim sxistence of a potential violation for comemP lated.

ggy would $s taken against an Public attendance, but rather to j which escalated enforcement action determine whether pmviding the public individual, or if the action, though not

, appears to be warrsated, or recurring with opportunities to be informed of taken against an individual, tums on j nonconformance on the part of a NRC activities is campatible with the vendor, the NRC may provide an whether en individual has committed

NRC's ability to exercise its regulatory doing.

opportunity for a predecia!onal. Qvolves significant personnel and safety responsibilities. Therefore, j enforcement conference with the failurse where the NRC has requested members of the public will be allowed

licensee, vendor, or other person before that the individual (s) involved be access to the NRC regional offices to 3 talang enforcement action. The purpose present at the conference attend open enforcernent conferences in of the conference is to obtain (3)la based on the findings of an NRC accordance with the " Standard information that will assist the NRC in Office ofInvestigations report

or Operating Procedures For Providing t determining the appropnate (4) Involves safeguards information. Security Support For NRC Hearings And i enforcement action, such as:(1) A Privacy Act information, or information Meetings," published November 1,1991 l common understanding of facts, root which could be considered proprietary: (56 FR 562511.These procedures

causes and missed opportunities In addition, conferences will not provide that visitors may be subject to l associated with the apparent violations, normally be open to the public if

personnel screening, that signs, banners,

(2) a common understanding of (5) The confeream involves medical postere, etc., not larger than 18" be

! corrective action taken or planned, and misedministrations or overexposures permitted, and that disruptive persons 1

' (3) a common understanding of the and the conference cannot be moducted may be removed.

significance ofissues and the need for without disclosing the exposed Members of the public attending open

lasting comprehensive corrective action. Individual's name: or conferenma will be reminded that (1) j If the NRC concludes that it has (6) The conference will be conducted the apparent violations diaen==d at j sufficient information to make an by telephone or the conference will be predecisional enforcement conferences

informed enforament decision, a conducted at a relatively small are subject to further review and may be 4

conference will not normally be held licensee's facility. su'oject to change prior to any resulting i

unless the li-- requests it. However. Notwithstand2ng meeting any of these enforcement action and (2) the

, an opportunity for a conference will criteria, a conference may still be open statements of views or expressions of normally be provided before issuing an if the conference involves issues related opinion made by NRC employees at

, order based on a violation of the rule on to an ongoing ad)ndt =*a y proceeding pr=dadalarial enforcement conferences, Deliberateun-h or a civil ty with mee or more intervanors or where or the lack thereof, are not intended to to an unH- a person.lf a rwm the evidentiary basis for the conference represent final determin=*i- or beliefs.

1 il

! NUREG-1600 8 i

Federal Register / Vol. So, N2,128 / Friday, June 30, 1995 / Notices 3438t7 j

i

! Persons ettending open onafuences will to be under oath. Norunauy, responses ====g===* lavolvensent in h====d he provided an opportunity to subadt under oath will be required only in activides and a decrease in protection of written -===*= osuourning the trial r====c*ia= with Severity level 1, H. or the public henhh and salsty.

Program anonymously to the regional M violations or orders. 1* Ben Qvu penal'I

! oSoe.These -*= will be N NRC uses the Notim of Violation i

y forwarded to the Director as the usual method for 48-8= the hNRCimposes d1Barentlevels of j of theDSon of Enferomment for review aw'eaan of a violation. lseuence of a penalues for di5erent severity level

! and e===idanation. Notica of Violation is normally the only violations and differentclasses of When needed to presse the public enforcement action taken, except in umna.==, vendors, and other persons.

l bealth and safety or-- defense casse where the criterisafor issusace of Tables 1A and 1B ahow the base dril 4

and security, ==n=lanant enforcement dwil p===let== and orders, as est forth in penalties for various r==cear, fuel cycle, action, such as the issuance of an heela== VI.B and VLC, respectively, are saaterials, and vendor programs. (Ovil

! i===dinaaly effective order, will be met. However, spedal circ ====*=a=' penalties issued to indmduals are taken before the conferenas. In these tegarding the violation findings may determined on a case by ase basis.) The

, ases, a conference snay be held aher the warrant disastion being exercised such structure of these tables generaHy takes 1 samlated enforament action is taken. that the NRC refrains from into account the gravity of the violation i

vunf--m-~e- "1" *'o!"Jntorll"ne*r"i' *"eJ:-) ghg o-r y =l:'d-"r.; a d*

1 This secdon deemibes the in ad on, licensees are not ordinarily ro..ia.,a on. GeneraHy, operations i J enforcement sanctions available to the died for violations resulting from involving greater nuclear mournal

NRC and specifies the canditions under matters not within their control, such as inventories and greater tial 4 which each may be used. The basic equipment failures that were not anaequences to the lic and licenses t

, enforcement sanctions are Notims of avoidable by :===anahle licenses quality receive dell

. Violation, civil penalties, and orders of assurance measures or management emplo[R88arding penalt the secondary 7

various types. As discussed further in controls. Generally, however, licensus factor of ability of various classes of '

j Section V1.D, related administrative are held responsible for the acts of their lima- to the civil penalties,it is

actions such as Notias of employees. Accordingly, this policy not h NRC niention that the Nonconfonnance, Notices of Deviation, should not be construed to excuse economic impact of a dvil penalty be so l j Confirmatory Action Letters, letters of personnel errors. severe that it puts a licenses out of B. CivilPenalty business (orders, rather than dvil t u lement the A civil penalty is a monetary penalty Penalties, are used when the intent is to i enforcement program. In a acting the enforcement sanctions or administrative that may be imposed for violation of(1) suspend or tenninete limnand activities) actions, the NRC will consider certain specified licensing provisions of or adversely affects a liconese's ability the Atomic Energy Act or to safely conduct licensed activities.

] enforcement actions taken by other The deterrent effect of civil penalties is Federal or State regulatory bodies supplementary NRC rules or orders: (2) j any requirement for which a license best served when b amounts of the having concurrent jurisdiction, such as in transportation matters. Usually, may be revoked: or (3) reporting Penalms take into account a ucensee's requirements under section 206 of the ability to psy. In determining the i whenever a violation of NRC amount of civil penalties for licensees i requirements of more than a mino. Energy Reorganization Act. Civil penalties are designed to deter future for whom the tables do not reflect h

concem is identifled. enforcement I action is taken. The nature and extent of violations both by the involved licensee ability to pay or the gravity of the violation, the NRC will consider as

! the enforcement action is intended to as well as by other licensees conducting similar activities and to emphasise the D"""y an inmense or decmass on a i reflect the seriousness of the violation

involved. For the vast majority of need for licensees to identify violations case-by case basia. Normally,if a conses can d I

! violations, a Notice of Violation or a and take pmmpt comprehensive P,

Notice of Nonconformance is the normal corrective action.

Civil penalties are considered for Payments over time, including interest, i action.

! Severity Level III violations. In addition, rather than reducing the amount of the

A. Non.ce of Violan. on dvil penalties will normally be assessed dvil penalty. However, where a licensee 4 A Notice of Violation is a written for Severity Level I and II violations and claisns financial hardship, the licensee j notice setting forth one or more knowing and conscious violations of the will normally be requhed to address

violations of a legally binding reporting requirements of section 206 of why it has sufBcient resources to safely requirement.The Notice of violation the Energy Reorganisation Act. conduct licensed activities and pay normally requires the recipient to Civil penalties are used to encourage license and inspection fees.

{

4 pmvide a written statement describing prompt identification and prompt and 2. Civil Penalty A a=======a' (1) the reasons for th( violation or, if comprehensive correction of violations, contested, the basis for disputing the to emphastas compliance in a manner in an effort to (1) emphaalpa the violation: (2) conective steps that have that deters future violations, and to importance of adherence to I

been taken and the results achieved: (3) serve to focus licenseos' attention on requirements and (2) reinforce prompt

. mrrective steps that will be taken to violations of significant tegulatory self-identification of pmbleras and root 4

prevent recurrence: and (4) the date conmen. muses and prompt and comprehensive when full complianes will be achieved. Although management involvement, correction of violations, the NRC

}'

The NRC mey waive all or portions of direct or indirect,in a violation may reviews each proposeo ctvil penalty on a written response to the extent relevant lead to an increase in the civil penalty, its own merits and, after considering all i

information has already been provided the lack of management involvement relevant circumstanas, may sojust tne to the NRC in writing or documented in may not be used to mitigste a dril base civil penalties shown in Table 1 A en NRC inspection report.The NRC may ty. Allowing mitigation in the and 1B for Severity involI, E, and E!

require responses to Notims of Violation tier mas could encourage the lack of violations as described below, d

9 NUREG4600 i

-c