ML20129E664
| ML20129E664 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1996 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20129E610 | List: |
| References | |
| REF-QA-99990002-960920 99990002-96-03, 99990002-96-04, 99990002-96-3, 99990002-96-4, NUDOCS 9610030235 | |
| Download: ML20129E664 (10) | |
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U. S. NUCLEAR REGULATORY-COMMISSION REGION II Docket Nos.: 030 19134, 999-90002 and 999-90002
- License No.: 52 16345 02MD i
Report Nos.: 52 16345 02MD/96 01, 999 90002/96 03 and 999 90002/96 04 4
Licensee: Diagnostic Photon Corporation Other Entities: Syncor Overseas Ltd. and Syncor International Corporation Location: Carolina, Puerto Rico i
Dates: July 26 and 29,1996, onsite Inspector: Hsctor Bermodez, Senior Radiation Specialist Approved by: John P. Potter, Chief Materials Licensing / Inspection Branch 2 Division of Nuclear Materials Safety i
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Enclosure 1 9610030235 960920 REG 2 GA999 EMVDIACP 99990002 PDR
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EXEClJTIVE
SUMMARY
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Diagnostic Photon Corporation, Syncor Overseas, Ltd. and i Syncor. International Corporation i NRC Inspection Report Nos. 52-19134-02MD/96-01, 999 90002/96 03 and 999 90002/96-04 This special, announced inspection was conducted to review the control and l conduct of licensed activities at the Diagnostic Photon Corporation's (DPC's) ,
radiopharmacy located in Carolina, Puerto Rico. This included a review of the <
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 i International Corporation (SIC) had taken control of licensed activities. The insaction included direct observation of activities in progress, discussions wit 1 cognizant DPC and Syncor Overseas. Ltd. (SOL) representatives, review of documents, and review of the organization and scope of the DPC's program.
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 prirr NRC consent, (2) the apparent failure of SIC to obtain a valid NRC license prior to possessing, using and distributing byproduct materials in .
Daerto Rico, (3) the apparent failure of 50L to obtain a valid NRC license I 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 failure of DPC to train personnel on the requireinents of its operating and emergency procedures and license, and (6) the use by DPC of unauthorized l operating procedures. l LIST OF PERSONS CONTACTED Licensee
- J. Caama50, M.D., President and Radiation Safety Officer .
N. Oldham, Alternate Radiation Safety Officer !
- A. Gonz&lez Gsigel, Esq., Licensee's Counsel Syncor Overseas. Ltd.
R. Green, Pharmacist ,
- F. Pe5a. Office Manager
- J. Simon, Pharmacist Syncor International Corooration
- F. Pe a, Office Manager
- J. Simon, Pharmacist
- By telephone during both the inspection and exit interview
- Represented both Syncor International Corporation and Syncor Overseas. Ltd.
during the exit interview with SOL on July 29, 1996 l
l REPORT DETAILS
- 1. Backaround 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 a consultant and that all other DPC employees, including the Alternate RSO designated on the NRC license, were to become employees of SIC.
- 2. Circumstances Leadina to the Inspection In early March 1996. DPC's President advised the NRC that he had recently allowed SIC to manage his pharmacy pending a potential transfer 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 warranted at that time. DPC's President was informed that NRC believed it would be prudent to delay any inspection for apprnximately three months and that it was important that he carefully monitor the transition in operations.
On March 25, 1996. DPC requested an amendment to its license. The letter referenced the Agreement and mentioned a pending transfer of the l 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 i
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 ins)ection was warranted at that time. DPC's President indicated tlat: (1) he had lost '
control over licensed activities, (2) he did net like the way in which !
activities were being conducted at his facility, and there was little he 1 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 i Region II a co)y of the Agreement. The SIC representative indicated )
that he used t1e Agreement as hit 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.
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), i 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, ,
nor the Alternate RSO designated on the license, were in control of licensed activities, there was no valid license under which SIC was operating. The President indicated that he would try to regain control 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 l Town. Tortola, British Virgin Islands. On July 19, 1996, S0L, requested NRC to transfer DPC's NRC license to their name and that a new RSO be named. NRC's response to this request is discussed in Section 4 of this report.
On July 22, 1996. DPC's Alternate RSO was escorted out of the facility 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 RSO 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. Inspection Results 3.1 Observations and Findinas Recardina DPC i 1
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 wrson unless the Commission, after securing full 4 information, finds t1at the transfer is in accordance with the I 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: l
- a. From review of records and discussions with S0L representatives. l between March 1 and July 16, 1996, and between July 16 and July ;
29, 1996, SIC and SOL, res actively, rotated pharmacists who practiced at various SIC plarmacies located on the mainland into DPC 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. SOL 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 Oprations Manual for the conduct of licensed activities and that he had not received training on DPC's o mrating and emergency procedures. The pharmacist indicated tlat 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.
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, 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.
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! d. The DPC RSO and Alternate RS0 were restricted from access to the l
! pharmacy. Through discussions with the DPC RS0, Alternate RSO and S0L representatives, the inspector determined that the Alternate i RS0 was escorted from the facility on July 22 by SOL staff. This action was related to a purchase and gift transfer of thallium 201, a transaction that SOL considered contrary to l l another agreement between DPC and SIC. S0L representatives stated )'
l that the alleged inap3ropriate transfer of thallium 201 was the i reason for changing tie locks to the facility. An SOL
. representative indicated that, if and when DPC's President / RSO wishes to access'the facility to supervise licensed activities as
.l- required by his function as RSO, he must be allowed in by SOL-i personnel without restriction but SOL personnel must be onsite I
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 4 the pharmacy, indicated, on June 28, 1996, that the Agreement allowed him to control the pharmacy. 'The representative indicated j 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 2
and his inability to ascertain the credentials of dispensing )harmacists at his facility, (3) the fact that SIC and SOL dictated who t1e
] Authorized Nuclear Pharmacists (ANPs) would be,' without any input from' l
- 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 i 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 l was his understanding that he was to operate under SIC's Operations Manual (6) the fact that SIC and SOL representatives implemented changes to the licensed program without DPC or NRC approval by changing 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 1 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 ,
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5 reliance on SIC and SOL pharn:acists, whose credentials are unknown to him, to supervise the licensed program, the inmector concluded that an a) parent transfer of control of the NRC license occurred without prior NtC consent.
The transfer of control of the NRC license without the NRC's prior consent was identified as an apparent violation of
3.1.2 Failure to Submit Credentials of ANPs 10 CFR 32.72(b)(5) requires that a licensee 3rovide 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 state pharmacy licensure or registration, no later than 30 days after the date that the licensee allows the individual to work as an Authorized Nuclear Pharmacist (ANP).
Through discussions with DPC and SOL re)resentatives and reviews of records, the inspector determined that yetween March 1 and July 29, 1996 DPC allowed six individuals to practice as ANPs. As of the date of this repcrt, 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. 50L re)resentatives indicated that it was
,. DPC's res)onsibility 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 Operatino and Emeraency 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.
AsdiscussedinSection3.1.1above,thesharmacistrepresentingSOLthe weeks of July 15 and 22,1996 stated to tu 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 )harmacist on the operating and emergency procedures contained in t1e license was identified as an apparent violation of 10 CFR 19.12.
3.2 Findinos Reaardino SIC and S0L 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 SQL, respectively, conducted activities subject to NRC licensing without a valid NRC license. Specifically, in their respective timeframes, both SIC and SOL 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 a) proved by the NRC and there was no other license issued to SIC or S0_ 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.
- 4. Developments Subseauent to the Inspection
! In response to the NRC onsite inspection findings, a Confirmatory Action Letter (CAL) was issued to SOL on Juiy 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 radiat%n safety program.
On August 19, 1996, the SQL President, responded to the CAL in writing to the NRC. The letter described restrictions to the DPC RS0 on access j to the facility. However, it indicated the RSO and DPC held
7 responsibility and control for the license. The letter informed the NRC 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 1 of the DPC license to comply with 10 CIR 30.34, if implemented as !
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 i 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.
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 SQL 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 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 / SOL 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.
1 The lead S0L representative onsite on July 29, 1996, took exception to the inspection findings involving SIC and 50L. Th SOL representative indicated that, if DPC were not in control of licensed activities, SQL would have proceeded with activities they desired to conduct that DPC's President did not want to conduct. The 50L representative indicated that such activities included compounding and distributing therapeutic dosages of iodine 131. Based on this, the lead SOL 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 S0L wanted to conduct against the wishes of DPC's President, the inspector l
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 OPERATING AND EMERGENCY PROCEDURES 96001-04 VIO USE OF UNAUTHORIZED OPERATING PROCEDURES 999 90002/96003 01 VIO SOL OPERATING WITHOUT A VALID NRC LICENSE 999 90002/96004 01 VIO SIC OPERATING WITHOUT A VALID NRC LICENSE I
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UNITED STATES NUCLEAR REGULATORY COMMISSION - ;
0FFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON. 0.C. 20555 .
l May 1, 1996 l r
! NRC INFORMATION NOTICE 96-28: SUGGESTED CUIDAEE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION i
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 i implementation of corrective actions that should be considered after i 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. .;
I Backaround On June 30. 1995. NRC revised its Enforcement Policy (NUREG-1600)2 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. ;
i In many cases, licensees who identify and promptly correct non-recurring !
Severity Level IV violations, without NRC involvement, will not be subject to l formal enforcement action. Such violations will be characterized as "non- !
cited" violations as provided in Section VII.B.1 of the Enforcement Policy, i 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) 4
.9604290 0 3--
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2 Copies of NUREG-1600 can be obtained by calling the contacts listed at l
the end of the Information Notice.
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IN 96-28 -
May,1. 1996 Page 2 of 6 which constitutes a notice of violation that requires corrective action but i 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 l sanction proposed or imposed. '
Discussion ,
Comprehensive corrective action is required for all violations. In most cases. NRC does not propose imposition of a civil penalty where the licensee promotly identifies and comprehensively corrects violations. However, a Seve f ty Level III violation will almost always result in a civil penalty if a l licensee does not take prompt and comprehensive corrective actions to address I 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 1 i arevent recurrence of the violation and the occurrence of similar violations. <
3rompt comarehensive action to improve safety is not only in the public )
interest. Jut 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 l 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 implementing corrective action.
Corrective action should be appropriately comprehensive to not only prevent I recurrence of the violation at issue but also to prevent occurrence of i similar violations. The guidance should help in focusing corrective actions 1 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 the violation. Typically, such reviews include:
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. Interviews with individuals who are either directly or indirectly l involved in the violation, including management personnel and those l responsible for training or arocedure development / guidance.
Particular attention should 3e paid to lines of communication j between supervisors and workers.
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IN 96-28 May 1. 1996 Page 3 of 6
- e. 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 o3eration under review. During the tour, individuals should loo ( 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 progr'ams. procedures, audits, and records that relate directly or indirectly to the violation. The program should be reviewed to ensure that its overall objectives and requirements are clearly stated and implemented. Procedures should be reviewed to determine whether they are com)1ete. logical, understandable, and meet their objectives (i.e.. t1ey should ensure compliance with the current requirements). Records should be reviewed to determine whether there is sufficient documentation of necessary tasks to 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.
- 2. Identifv 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 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 training, lack of attention to detail, and inadequate time to carry out 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.
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May 1, 1996 Page 4 of 6
- 3. Take 0-omot 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, immediate corrective action must be taken to place the material under licensee 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 4 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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- 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 appreciate 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 relationship of the radiation safety officer to provide increased independence)?
- 16. Are management and the radiation safety officer adequately involved in oversight and implementation of the licensed activities? Do supervisors 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?
- 18. Has management placed a premium on production over compliance and '
safety? Does management demonstrate a commitment to compliance and i safety?
- 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?
1
r, IN 96-28 -
May 1. 1996 Pag 6 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.
1 signed by signed by Elizabeth 0. Ten Eyck. Director Donald A. Cool Director Division of Fuel Cycle Safety 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: bib @nrc. gov j Gary F. Sanborn. RIV j (817) 860-8222 Internet:gfs@nrc. gov Attachments:
- 1. List of Recently Issued NMSS Information Notices
- 2. List of Recently Issued NRC Information Notices
}
j 34388 Federal Register / Val. So, No.128 / Friday, June 30, 1996 / Noticas !
4 l factors in arriv at this a priate is not held, the licensee will normally is a matter of record,such as an
! severity level be t on the be requested to provide a written ad> dim *=y alan by the cire===*==== of the vi tion. if
+
response to an laspection However, if a licenses refuses to correct issued, as to the lima U- oflabor.in addition, with !
's on the the approval of the Executive Dhector .
! a minor violation within a reasonable apparent violations and their root for Operations, conferemosa wi!! not be '
l time such that it willfully continues, the causes and a description of planned or open to the public where good cause has
, violation should be categorised at least . In tad cormative action. been shown after halancing the beneSt j at a SeverityinvolIV. the pr=darialanal sniorcement of the ublic observation against the conferena,the Hamme,vendw or poten impact on the esency's D. Violations ofJieporti"I Jl oquirements
- ather persons willbe given an anim===aneaction in a particular case.
The NRC expects liaana=== to provide opportunity to provide information As soon as it is detonnined that a i complete, accurate, and tirnely mm.ian.ne with the purpose of the conference willbe open to public information and reporta. Accordingly, maiorence, including an explanation to observation, the NRC will
.' unless otherwies - . Min the the NRC of the immediate corrective licenses that the conference the be i Supplements, the severity level of a actions (if any) that were taken oPen to public observation as part of the j violation involving the failure to make following identi8 cation of the potential agency'strialprogram.rs==ia e with
- a required report to the NRC will be violation or nanmninemance and the the 's policy on open meetings, i based upon the signiScence of and the long-term comprehensive actions that "S Meetings to Public "
circurnstances surrounding the matter were taken or will be taken to prevent 20,1934 (59 PR Publiebed that abould have been reported, mcurrence. l.icenseen, vendors, or othw 48340), the intends to announa However, the severity level of an persons will be told when a meeting is oPen conferences normany at least to untirnely report,in contreet to no mpwt, a prededsional enforcement conference working days in advance of conferences j may be reduced depending on the A pr=dariaional enforcement through (1) notices posted in the Public j circumstances swW' - the matter, conference is a meeting between the narn-t Room.(2) a toll-fme
! A licenses will not norsnaDy be cited for NRC and the licensee. Conferences are telephone et sotN152-4674, j a failure to report a condition or event normally heldin the regionalomcas and (3) a toll-free e bulletin 1 unless the licensee was actually awar* and are not normally open to public board at solHp52-0676. In addition, the
- of the condition or event that it failed observation. However, a trial program is NRC will also issue a press release and 1
to report. A licensee will, on the other being conducted to open approximately notify appropriate State liaison oBeers j hand, normally be cited for a failure to 25 percent of all eligible conferences for tbt a predecisional enforcement
! MPort a condition or event if the public observation, i.e., every fourth conference has been scheduled and that j liconen knew of the information to be eligible conference involving one of it is open to public observation.
j reported, but did not recognise that it three categories of limnases (reactor. The public attending open
- was required to make a apwt. hospital, and other meterials licensees) conimacu under the trial may V. Fredaelata=al Enforcement will be open to the public. Conferenom observe but not participate Confomaces will not normally be open to the public """Ience. It is noted that the purpose ;
Whenever the NRC has learned of the if the enforcernent action being of conducting open confosenes under d the trial program is not to =avimi==
existence of a potential violation for coni *mplatb. Public attendance, but rather to which escalated enforcement action gg)wo I o taken against an j determine whether providing the public sppears to be warranted, or recurring individual, or if the action.though not 4
taken against an individual, tums on with opportunities to be informed of a nonconformance on the part of a NRC activities is compatible with the 4
vendor, the NRC may provide an whether en individual has committed NRC's ability to esercias its regulatory opportunity for a predecisional and safety respannihilities. Therefore, y a signi8 cant personnel enforcement conference with tlie failures where the NRC has requested members of the public will be allowed i
licensa, vendor, or other person before that the individual (s) involved be access to the NRC regional offices to
{ taking enforcement action. The purpme attend open enforcernent conferences in present at the conference, of the conference is to obtain (3)Is based on the findings of an NRC accordance with the ** Standard j information that will assist the NRC in Office ofInvestigations moort; or Operating Procedures For Providing
! determining the appropriate (4) Involves saloguards information, Security Support For NRC Hearings And j enforcement action, such as:(1) A Privacy Act information, or information Meetings." publiabed November 1.1991 i common understanding of facts, root which could be considered proprietary; (56 FR 56251).These procedures causes and mi==ad opportunities in addition, conferences will not provide that visitors may be sub to associated with the apparent violations, normally be onan to the public if: personnel screening, that signs. ,
(2) a common understanding of (5) The conference involves medical posters, etc..not larger than 18" be 4 cormctive action taken or planned, and misadministrations or overexposums permitted, and that disruptive persons
]
' (3) a common understandiaC of the and the conferorce cannot be conducted may be removed.
signlAcance of issues and the need for without disclosing the exposed Members of the public attending o l lasting comprehensive corrective action. Individual's name: or conferences will be reminded that (1
- If the NRC concludes that it has (6) The conference will be conducted the apparent violations dim ===d at i sufficientinformation to make an by telephone or the conference will be predecisional enforcement conferences A informed enforament decialon, a conducted at a relatively small are subject to further review and may be conference will not normally be held licensee's facility. subject to change prior to any resulting unless the limnses requests it. However. Notwithstanding meeting any of these enforcement action and (2) the
, en opportunity for a conference will criteria, a conference rney still be open statements of views or expressions of d
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 adjudicatory proceeding predecisional enforcement conferences, i or the lack thereof, are not intended to Deliberate Misconduct or a civil penalty with one or more intervonors or where j to an unliannaad person. lf a co= =
the evidentiary basis for the conference represent final determinations or beliefs.
9 j NUREG-1600 8 a
. - . . _ _ _ _ _ . _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ ~ ,
l Federal Register / V:1. 60, No.126 / Friday, June 30, 1995 / Notices 34387 i
l Persons attending open conferences will ts be under oath. Normany, r==ra== ===ag== lavol 8 in ll===ad i be provided an opportunity to subadt under oath will be required only in activities amid a decsease in protection of j written e=====*= comer.dag the trial cannac*ian with Severity Invel l, H, or the public health and safety. l
. Program anonymously to the agional Elvioledoes or orders.
ofBoe.nese
-*= will be %e NRC uses the Notice of Violation 1* Base Civil PenaNY 4 -
- y forwarded to the Director as the usualmethod for L -"-" the b NRC imposes di5erent levels of i
of theDiBoo of Enforcement for review avi=*=== of a violation. lasuance of a penshies for diferent severity level j and consideration. Notice of Violation is normaDy the only violations and differer.t classes of
' When needed to protect the lic enforcement action taken, enoopt in j
1t== , vendors, and other persons. =
hoekh and safety or --a= cases where the critorirfor issumara of Tables 1A and 1B show the base civil i and escurity, ===l=*ad enforcement civil penalel== and ordera, as set forth in penaldes for various reactor, fuel cycle, action, such as the issuance of an macelana VI.B and VI.C. ro9ect voly, are materials, and vendor programs. (Civil ,
i==adiately effective order, will be met. However, special cit aamstances penalties issued to individuals are i taken before the conference. In these regarding the violation Bndings may determined on a case by-com basis.)h cases, a conference may be held escalated enforcement action is enk,a. aber the warrant discretion being exercised such structure of these tables generally takes
- . that the NRC refrains from issuing a into account the gravity of the violation yg, 3,g,, as a primary consideration and the Notice Mm of Violation.
on of Enforcement(See Section VII.B.,,)
A==<*iana This section describes the abuity to pay as a ==cand= y i in tion, licensees are not ordinaril) consideration. Generally tions
! enforcement ===ctians available to the died for violations resulting from NRC and speciBee the conditions under mettere art within their control, such as involvi nucleE terial gn,,, gal l
{
which each may be used.The basic enforcement sanctions are Notices of equipment failures that were not avoidable by :===aaahle liconese quality 8"[ig g ""
- Violation, civil penalties, and orders of assurance measures or management 7emP og"'
i various types. As diaru==ad furtherin controls. Generally, however, licenseesSection VI.D related administrative (r of ability of various classes of are held responsible for the acts of their actions such as Notices of 1a====== to the civil penalties, Iris employees. Accordingly, this policy not the NRC tention that the Nonconformance, Notices of Deviation, should not be construed to excuse Confirmatory Action latters. latters of personnel errors-
- 0"omic imPect of a civil penalty be so imand, and Dernands for severe that it puts a licenses out of j Re[ormation in are used to supplement the B. CivilPenalty business (orders, rather than civil '
enforament program, in selecting the A civil penalty is a monetary penalty Penalties, are used when the intent is to enforcement sanctions or administrative that may be imposed for violation of (1) suspend or terminate licensed activities) actions, the NRC will consider artain specified licensing provisions of or adversely affects a lle====='s ability enforcement actions taken by other the Atomic Energy Act or to esfely conduct licensed activities.
Federal or State regulatory bodies supplementary NRC rules.or orders: (2) The deterrent effect of civil penalties is having concurrent jurisdiction, such as any requirement for which a license best asmd when the amounts of de in transportation matters Usually, may be revoked: or (3) reporting Penakies take ing account aconese's whenever a violatter.of NRC requirements under section 20s of the ability to pay. In --- ; the requirements of more than a niinor En y Reorganization Act. D.vil amount of civil penahnes for liconeses concem is identified, enforcen ont pena ties are designed P. det er future for whom the tables do not reflect the action is taken. The nature and extent of violations both by tha involvci licensee ab831ty to pay or the gravity of the the enforcement action is inten< led to as well as by other licensees conducibg violation,the NRC wiH cnosider as j reflect the seriousness of the vblation hasise the necessary an increase or decrease on a , involved. For the vast u alori*y of similar activities and need for licensees to identi to emh violations c%m basis. NamaHy.If a ! violations, a Notice of Violation or a and take prompt comprehensive IIC'"'**C8"d'm*"8'"I*0"*"CI*I Notice of Nonconformance is the normal corrective odion, hardship, the NRC will consider action. Civil penalties are considered for Pe to over time, including interest, Severity Level RI violations. In addition, re than reducing the amount of the A. Notice of Violation civil penalties will normally be assessed civil enalty. P However, where a liconese A Notim of Violation is a written for Severity level I and H violations and claims Anancial hardship, the licenses notice setting forth one or more knowing and conscious violations of the will normally be required 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. provide a written statement describing prompt identification and prompt and 2. Civil Pensky Assessment (1) the reasons for the violation or, if comprehensive correction of violations, contested, the basis for disputing the to emphasias compliance in a manner in an effort to (1) emphaelse the violation: (2) corrective steps that have that deters future violations, and to importance of adherone to been taken and the results achieved; (3) serve to focus licensees' attention on requirements and (2) reinforce prompt merective steps that will be taken to violations of signifimat regulatory self-identillation of problems and root prevent recurrena: and (4) the dato con men. causes and prompt and mmprehensive when full compliance will be achieved. Although management involvement, correction of violations, the NRC The NRC may waive all or portions of direct or indirect. in a violation may reviews each proposed civil penalty on a written response to the extent relevent lead to an increase in the civil penalty, its owe merits and, after considering all information has already been provided the lack of management involvement relevaat circumstances, may adjust the to the NRC in writing or documented in may not be used to mitigste a civil base civil penalties shown in Table 1A en NRCinspection report.The NRC may penalty. Allowing mitigation in the and 1B for Severity Imvoll, H, and IR require responses to Notices of Violation latter case could encourage the lack of violations as described below. 9 NUREG-1600
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