ML18116A055
| ML18116A055 | |
| Person / Time | |
|---|---|
| Site: | 03013426 |
| Issue date: | 04/24/2018 |
| From: | Kennedy K M NRC Region 4 |
| To: | Honeycutt R Providence Alaska Medical Ctr |
| References | |
| EA-17-182 IR 2017001 | |
| Download: ML18116A055 (11) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION REGION IV EA-17-182 Robert Honeycutt Chief Operating Officer Providence Alaska Medical Center 3200 Providence Drive P.O. Box 196604 Anchorage, AK 99519-6604 1600 EAST LAMAR BOULEVARD ARLINGTON, TEXAS 76011-4511 April 24, 2018
SUBJECT:
NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY-$11,600, NRC SPECIAL INSPECTION REPORT 030-13426/2017-001
Dear Mr. Honeycutt:
This letter refers to the special inspection conducted on June 27-30, 2017, at your facility in Anchorage, Alaska. The inspection was conducted in response to a medical event involving an incorrect dose of radiation to the patient's liver that occurred on June 14, 2017, and was reported to the U.S. Nuclear Regulatory Commission (NRC) Operations Center (Event Notification 52807) on June 15, 2017. The inspectors discussed the preliminary inspection findings with you and members of your staff on June 30, 2017, at the conclusion of the onsite portion of the inspection.
A final exit briefing was conducted telephonically with you and members of your staff on January 3, 2018, and the details regarding three apparent violations were provided in NRC Inspection Report 030-13426/2017-001, dated February 2, 2018 (NRC's Agencywide Documents Access and Management System (ADAMS) Accession ML 180338654).
On April 3, 2018, a predecisional enforcement conference was conducted in the Region IV office with you and other licensee representatives to discuss the apparent violations, their significance, their root causes, and your corrective actions. During the conference, you stated that you did not contest the violations and you provided additional information about your long-term corrective actions. Based on the information developed during the inspection and the information that you provided during the predecisional enforcement conference, the NRC has determined that three violations of NRC requirements occurred.
These violations are cited in Enclosure 1, Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involved failures to: (1) have written directives dated and signed by an authorized user before the administration of any therapeutic dose of radiation from byproduct material; (2) develop, implement, and maintain written procedures to provide high confidence that administrations are in accordance with written directives; and (3) provide training to all individuals involved in yttrium-90 microsphere use, commensurate with the individual's duties.
R. Honeycutt 2 The NRC considers these violations significant because they resulted in deficiencies in the development and implementation of policies and procedures designed to provide a high confidence that the correct activity of yttrium-90 microspheres (TheraSphere) would be ordered from the manufacturer, that the activity received would be checked and verified against the planned activity prior to the administration, and that the planned activity would be administered to the patient. As a result, the deficiencies contributed to the occurrence of the June 14, 2017, medical event. Therefore, these violations have been categorized collectively in accordance with the NRC Enforcement Policy as a Severity Level II problem. In accordance with the Enforcement Policy, a base civil penalty in the amount of $11,600 is considered for a Severity Level II problem. The NRC considered whether credit is warranted for both Identification and Corrective Action in accordance with the civil penalty assessment process in Section 2.3.4 of the Enforcement Policy. The NRC determined that credit is not warranted for Identification due to missed opportunities and the failure to evaluate the full extent of the problem requiring corrective action. Specifically, when responsibility for the oversight of the yttrium-90 microspheres (TheraSphere) procedures was transferred from your Radiation Oncology Department to the Nuclear Medicine Department, your staff did not follow the established Departmental Policy for yttrium-90 microspheres (TheraSphere) therapy. Moreover, your staff did not raise questions about procedure adherence despite numerous instances of performing yttrium-90 microspheres (TheraSphere) administrations.
Furthermore, routine audits performed by your staff did not identify that NRC regulatory requirements and your procedures were not being followed.
Additionally, following the occurrence of the medical event, your staff was focused on a belief that the cause of the medical event was isolated to an error made by a single person. Your staff did not evaluate the full extent of the problem requiring corrective action (i.e., implementation of the written directive process and the checks to ensure the correct activity of yttrium-90 microspheres (TheraSphere) was ordered, received and administered) until the NRC inspector identified the programmatic nature of the failures to hospital management.
Since Identification credit is not warranted, a base civil penalty is considered.
The NRC concluded that Corrective Action credit is warranted based on your immediate and long-term corrective actions; therefore further escalation of the civil penalty is not appropriate.
Following the special inspection, you suspended the use of yttrium-90 microspheres (TheraSphere) procedures until you better understood the circumstances of the medical event. After an evaluation of the root cause, your corrective actions included:
(1) the performance of a series of audits to identify deficiencies; (2) process changes for the preparation and review of written directives, the ordering of yttrium-90 microspheres (TheraSphere) doses, and the verification of yttrium-90 microspheres (TheraSphere) vial activity against the written directive; (3) staffing changes; (4) retraining staff involved with yttrium-90 microspheres (TheraSphere) procedures; (5) providing additional Radiation Safety Officer oversight of the yttrium-90 microspheres (TheraSphere) program; (6) engaging the yttrium-90 microspheres (TheraSphere) vendor to incorporate feedback on the ordering process; and (7) revising the written procedures for performing yttrium-90 microspheres (TheraSphere) administrations.
Further details of the corrective actions are documented in the predecisional enforcement conference meeting summary dated April 6, 2018 (ADAMS Accession ML 18100A252).
R. Honeycutt 3 Therefore, to emphasize the importance for properly administering therapeutic doses of radiation from byproduct material and the prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice in the base amount of $11,600 for the Severity Level II problem. In addition, issuance of this Notice constitutes an escalated enforcement action that may subject you to increased inspection effort. If you disagree with this enforcement sanction, you may deny the violation, as described in the Notice, or you may request alternative dispute resolution (ADR) with the NRC in an attempt to resolve this issue. Alternative dispute resolution is a general term encompassing various techniques for resolving conflicts using a neutral third party. The technique that the NRC has decided to employ is mediation.
Mediation is a voluntary, informal process in which a trained neutral mediator works with parties to help them reach resolution.
If the parties agree to use ADR, they select a mutually agreeable neutral mediator who has no stake in the outcome and no power to make decisions.
Mediation gives parties an opportunity to discuss issues, clear up misunderstandings, be creative, find areas of agreement, and reach a final resolution of the issues. Additional information concerning the NRC's ADR program can be found in Enclosure 3 and at http://www.nrc.gov/about-nrc/regulatory/enforcement/adr.html. The Institute on Conflict Resolution at Cornell University has agreed to facilitate the NRC's program as a neutral third party. If you are interested in pursuing this issue through the ADR program, please contact: (1) the Institute on Conflict Resolution at (877) 733-9415, and (2) Mr. Michael Hay at 817-200-1455 within 10 days of the date of this letter. You may also contact the Institute on Conflict Resolution for additional information about ADR. Your submitted signed agreement to mediate using the NRC ADR program will stay the 30-day time period for payment of the civil penalties and the required written response, as identified in the enclosed Notice, until the ADR process is completed.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response.
If you have additional information that you believe the NRC should consider, you should provide it in your response to the Notice. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice and Procedure/
a copy of this letter, its enclosures, and your response will be made available electronically for public inspection in the NRC Public Document Room and from the NRC's ADAMS, accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the public without redaction.
The NRC also includes significant enforcement actions on its Web site at (http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/
).
R. Honeycutt 4 If you have any questions concerning this matter, please contact Mr. Michael C. Hay of my staff at 817-200-1455. Docket No. 030-13426 License No. 50-17838-01
Enclosures:
1 . Notice of Violation and Proposed Imposition of Civil Penalty 2. NUREG/BR-0254 Payment Methods 3. NUREG/BR-0317, Post-Investigation Alternative Dispute Resolution Program, Revision 1 cc: w/Enclosure 1 : Dr. Bernd Jilly, State of Alaska Radiation Control Program Director Sincerely, IL/// Kriss M. Kennedy Regional Administrator NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENAL TY Providence Alaska Medical Center Anchorage, Alaska Docket No.: 030-13426 License No.: 50-17838-01 EA-17-182 During an NRC inspection conducted on June 27-30, 2017, three violations of NRC requirements were identified.
In accordance with the NRC Enforcement Policy, the N~ proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of"! 954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below: A. 10 CFR 35.40(a) requires, in part, that a written directive must be dated and signed by an authorized user before the administration of any therapeutic dose of radiation from byproduct material.
Contrary to the above, from January 1, 2015, to June 27, 2017, the licensee failed to have written directives dated and signed by an authorized user before the administration of therapeutic doses of radiation from byproduct material.
Specifically, the licensee failed to have written directives dated and signed by an authorized user before the administration of approximately 40 therapeutic doses of radiation from byproduct material from yttrium-90 microspheres (TheraSphere).
B. 10 CFR 35.41 (a) requires, in part, that for any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive.
Licensee procedure 198.536 "Providence Alaska Medical Center -Departmental Policy Radiology-Nuclear Medicine," subject "TheraSpheres Therapy," dated November 11, 2013, specifies procedures and contains prerequisites for TheraSphere Therapy. Step 111.b.i, "Prerequisites for TheraSphere Therapy," requires, in part, that the written directive and dose calculation sheet is reviewed by the medical physicist and the medical physicist will notify the nuclear medicine personnel that the material can be ordered. Contrary to the above, from January 1, 2015, to June 27, 2017, the licensee failed to develop, implement, and maintain written procedures to provide high confidence that each administration was in accordance with the written directive.
Specifically, the licensee failed to implement its prerequisites for yttrium-90 microspheres (TheraSphere) therapy, including the medical physicist's failure to perform a review of the written directive and dose calculation sheet, and the failure of the medical physicist to provide direction to the nuclear medicine staff that the material could be ordered. Additionally, the licensee failed to properly develop its yttrium-90 microspheres (TheraSphere) procedure in that it did not describe methods to provide high confidence that each administration would be in accordance with the written directive, such as verification of ordered and received doses against the planned dose. Enclosure 1
C. License Condition 18 of NRC License Number 50-17838-01, Amendment No. 70, dated October 28, 2016, requires, in part, that the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed in License Condition
- 18. License Condition 18, letter dated April 4, 2016, requires, in part, that the licensee implement the NRC's licensing guidance, "Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Sphere Licensing Guidance," dated February 12, 2016, Revision 9. The NRC's licensing guidance requires, in part, that the licensee shall provide training in the licensee's procedures to all individuals involved in yttrium-90 microsphere use, commensurate with the individual's duties to be performed and that the training must be provided to all individuals preparing, measuring, performing dosimetry calculations, or administering yttrium-90 microspheres.
Contrary to the above, from October 28, 2016, to June 27, 2017, the licensee failed to provide training in the licensee's procedures to all individuals involved in yttrium-90 microsphere use, commensurate with the individual's duties to be performed.
Specifically, the licensee failed to provide training in the licensee's yttrium-90 microspheres (TheraSphere) procedures that was commensurate with the duties to be performed, to individuals, including the nuclear medicine staff, that were involved with ordering, preparing, and measuring yttrium-90 microspheres (TheraSphere).
This is a Severity Level II problem (NRC Enforcement Policy, Section 6.3.b) Civil Penalty -$11,600 (EA-17-182)
Pursuant to the provisions of 1 O CFR 2.201, Providence Alaska Medical Center, is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a copy to the Document Control Desk, Washington, DC 20555-0001, and the Regional Administrator, U.S. Nuclear Regulatory Commission, Region IV within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice).
This reply should be clearly marked as a "Reply to a Notice of Violation; (EA-17-182)" and should include for each violation:
(1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken; and (4) the date when full compliance will be achieved.
Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response.
If an adequate reply is not received within the time specified in this Notice, the NRC may issue an order or a demand for information requiring you to explain why your license should not be modified, suspended, or revoked or why the NRC should not take other action as may be proper. Consideration may be given to extending the response time for good cause shown. You may pay ,, the civil penalty proposed above, in accordance with NUREG/BR-0254 (Enclosure
- 2) and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice. Should you fail to answer within 30 days of the date of this Notice, the NRC may issue an order imposing the civil penalty. Should you elect to file an answer in accordance with 10 CFR 2.205 2 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation; (EA-17-182)" and may: (1) deny the violations listed in this Notice, in whole or in part; (2) demonstrate extenuating circumstances; (3) show error in this Notice; or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty. In requesting mitigation of the proposed penalty, the response should address the factors addressed in Section 2.3.4 of the Enforcement Policy. Any written answer addressing these factors pursuant to 10 CFR 2.205 should be set forth separately from the statement or explanation provided pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition.
The attention of the licensee is directed to the other provisions of 10 CFR 2.205 regarding the procedure for imposing a civil penalty. Upon failure to pay any civil penalty which subsequently has been determined in accordance with the applicable provisions of 1 O CFR 2.205 to be due, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c. The responses noted above, i.e., Reply to Notice of Violation, Statement as to payment of civil penalty, and Answer to a Notice of Violation, should be addressed to: Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, with a copy to the Document Control Desk, Washington, DC 20555-0001 and the Regional Administrator, U.S. Nuclear Regulatory Commission, Region IV, 1600 E. Lamar Blvd., Arlington, TX 76011-4511.
Your response will be made available electronically for public inspection in the NRC Public Document Room or in the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the public without redaction.
If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information.
If you request that such material be withheld from public disclosure, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or financial information).
In accordance with 10 CFR 19.11 , you may be required to post this Notice within two working days of receipt. Dated this 24th day of April 2018. 3 If you have questions, please visit https://www.nrc.gov and search for "License Fees." Questions may also be directed to the NRC Accounts Receivable Help Desk by e-mail at FEES.Resource@nrc.gov, by phone at (301) 415-7554, or by writing to the address below: U.S. NUCLEAR REGULATORY COMMISSION OCFO/DOC/ARB Mail Stop T9-E10 Washington, DC 20555-0001 APPROVED BY 0MB: NO. 315CHJ190 Estimated burden per response to comply with this voluntary collection request: 10 minutes. This brochure provides information about available payment methods. Forward comments about to burden estimate to the Records Management Branch (T6-F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0190), Office of Management and Budget, Washington, DC 20503. If a means used to impose an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
NRC accepts the methods described below. To pay by Automated Clearinghouse/
Electronic Data Interchange (ACH/EDI), provide a copy of NRC Form 628 to your financial institution.
You may obtain a copy of NRC Form 628 by calling the NRC Accounts Receivable Help Desk at (301) 415-7554.
The NRC is currently accepts credit card payments of up to $24 , 999.99. For payment by credit card, go to Pay.gov, search for "U.S. Nuclear Regulatory Commission Fees" and enter the required information.
You may also mail or fax NRC Form 629 following the directions on the form. To obtain a copy of NRC Form 629 go to http://www.nrc.gov and search for "NRC Form 629" or call the NRC Accounts Receivable Help Desk at (301) 415-7554. . .'!~F! [:.X~~~:-)j ~:?..l' i .II NT BY FEDWI1(E*1 DEROSIT , ----() ~1 -~ The NRC can receive funds through the U.S. Department of the Treasury (Treasury)
Fedwire Deposit System. The basic wire message format below complies with the Federal Reserve Board's standard structured third-party format for all electronic funds transfer (EFT) messages.
See the sample EFT message to Treasury below. Each numbered field is described below. :=iLl ~R0:21030004 Cl. I REF ~----***--***-***-1 $ a.m~~~m Og ' BNF-/AC-31000001 OB I-8 RECEIVER-DFI#-
Treasury's routing number for deposit messages is 021030004.
@TYPE-SUBTYPE-CD
-The sending bank will provide the type and subtype code. 8 SENDER*DFI#
-The sending bank will provide this number. 9 SENDER-REF#-
The sending bank will insert this 16-character reference number at its discretion.
@AMOUNT -The transfer amount must be punctuated with commas and decimal point; use of the "$" i s optional.
The depositor will provide this item. Q SIENDER*DFl*NAME
-The Federal Reserve Bank will automatically insert this information.
f) RECEIVER*DFl*DME
-Treasury's name for deposit messages is "TREAS NYC". The sending bank will enter this name. f3 PRODUCT CODE-A product code of "CTR" for customer transfer should be the first item in the reciever text field. Other values may be entered, if appropriate, using the American Bankers Association's options. A slash must be entered after the product code. 0 AGENCY LCCATION CODE (ALC) -THIS ITEM IS OF CRITICAL IMPORTANCE.
IT MUST APPEAR ON THE FUNDS TRANSFER DEPOSIT MESSAGE IN THE PRECISE MANNER AS STATED TO ALLOW FOR THE AUTOMATED PROCESSING AND CLASSIFICATION OF THE FUNDS TRANSFER MESSAGE TO THE AGENCY LOCATION CODE OF THE APPROPRIATE AGENCY. The ALC identification sequence can, if necessary, begin on one line and end on the next line; however, the field tag "BNF=" must be on one line and cannot contain any spaces. The NRC's 8-digit ALC is: BNF=/AC-31000001 CI,) THIRD-PARTY I NF O RMATION -The Originator to Beneficiary Information
{OBI) field tag " OBI=" signifies the beginning of the free-form third-party text. All other identifying information intended to enable the NRC to identify the deposit-for example, NRC annual fee invoice number, description of fee, 1 O CFR 171 annual fee, and licensee name-should be placed in this field. The optimum format for fields 7, 8, 9, and 1 o using an 8-digit ALC is as follows: TREAS NYC/CTR/BNF=/AC-31000001 OBI= The optimum format, shown above, will allow 219 character positions of information following the "OBI=" indicator.
If the licensee's bank is not a member of the Federal Reserve System, the nonmember bank must transfer the necessary information and funds to a member bank, which then must transfer the information and funds to the local Federal Reserve Bank. For a transfer of funds from local Federal Reserve Banks to be recorded on the same day, the transfer must be received at the New York Federal Reserve Bank by 4 p.m., EST. Otherwise, the deposit will be recorded on the next workday. Checks should be made payable to the U.S. Nuclear Regulatory Commission with the invoice number, Enforcement Action number, or other information that identifies the payment, written on the check. Mail the check to the following address: U.S. Nuclear Regulatory Commission U.S. Bank P.O. Box 979051 St. Louis, MO 63197-9000 FedEx or overnight mailings must be delivered to the following address: U.S. Nuclear Regulatory Commission U.S. Bank Government Lockbox SL-MO-G2GL 1005 Convention Plaza St. Louis, MO 63101 You must file your Taxpayer Identification Number {TIN) with the NRC. Use NRG Form 531 to provide your TIN. You may obtain NRC Form 531 from the NRG Web site at http://www.nrc.gov by searching for "NRC Form 531" or by calling the NRC Accounts Receivable Help Desk at {301) 415-7554.
The parties usually hold the mediation at, or in the vicinity of, one of the NRC's offices. However, the parties may mutually agree upon any alternate location.
Mediation sessions are usually no longer than 1 day. In some cases, the mediation may take longer than 1 day with the mutual consent of the parties. The responsible Regional Administrator or his or her designee will serve as the principal negotiator for the NRC in cases that involve wrongdoing and related technical issues, if any. When a case involves discrimination, the Director of the Office of Enforcement will normally serve as the principal negotiator.
The other members of the NRC mediation team typically include an enforcement specialist, an attorney, and a staff representative who is familiar with the technical issues under discussion.
A CO is a legally binding document that includes th e terms of the AIP. For a licensee, a CO serves as an amendment to its NRC license. Regardless of the type of entity, a CO has the same legal force against any party to which it is issued. The NRC will only issue a CO with the prior written consent of the other party, and with a waiver of the right to a hearing. After the entity or the individual, as applicable, has completed the terms of the CO, the NRC will conduct verification activities to ensure that the terms of the CO have been satisfied in a timely manner. Because the CO is legally binding, failing to comply with its terms exposes the entity or individual to additional enforcement action. Although the substance of the mediation session remains confidential, the details of the settlement will normally be made public via a press release and the publication of the CO in the Federal Register.
The timely resolution of issues is one of the goals iof the post-investigation ADR program. Accordingly, the NRC expects a timely progression of a case at each stage of the mediation process. In cases where the parties achieve settlement, the NRC expects to issue a CO within 90 calendar days of the date of the agency's letter offering the ADR option to an entity the other party. Further information about the NRC's ADR program is available from the following:
- Cornell toll free at (877) 733-9145
- NRC ADR Program Manager in the Office of Enforcement toll free at (800) 368-5642 or (301] 415-2741
- NRC enforcement ADR program on the agency's Web site at www.nrc.gov/about-nrc/regulatory/
enforcement/adr.html rY"""REOc,<., l~~\ : . 0 Ill ~i : \.. I ... .,, +o it-,.. .... NUREG/BR-0317 Rev. 1 July 2011 USNR~~---~ . . .. b--. ., , ... ~'TL!' Un i ted Stgtc, Nuclca t Regul no ty t'~m~dol>, '\<. Protecting People and the Enviro~"!!!!' *
- The U.S. Nuclear Regulatory Commission's
[NRC's) post-investigation alternative dispute resolution (ADR} program provides an amicable process to resolve enforcement matters. It may produce more timely and effective outcomes for the NRC and an entity [e.g., an NRC licensee, certificate holder, or contractor of an NRC licensee or certificate holder) or an individual who is subject to an enforcement action. Following the congressional endorsement of the use of ADR by Federal agencies, the NRC established the post-investigation ADR program in 2004. Post-investigation ADR offers the opportunity to resolve discrimination cases or other wrongdoing and related matters through mediation rather than through the NRC's traditional enforcement process. Post-investigation ADR refers to the use of mediation after the completion of an investigation by the NRC Office of Investigations and the staff's conclusion that pursuit of an enforcement action appears warranted.
As long as the enforcement matter is within the scope of the program, the NRC normally offers investigation ADR at each of the following stages of the enforcement process: (1) before an initial enforcement action, (2) after the initial enforcement action is taken, typically upon issuance of a notice of violation, and (3) when a civil penalty is imposed but before a hearing request. Mediation is an informal process in which a trained and experienced mediator works with the parties to help them reach a resolution.
The parties are the NRC and the entity or an individual, as applicable, in the mediation.
The mediator focuses the attention of the parties on their needs and interests rather than on their stated positions.
Mediation gives the parties an opportunity to discuss issues, clear up misunderstandings, identify creative ways to address issues, find areas of agreement, and resolve their dispute. Participation in the program is entirely voluntary.
The NRC and the entity or the individual, as applicable, may withdraw from the mediation process at any time. The NRC has a contract with the Cornell University Scheinman Institute on Conflict Resolution (Cornell) to serve as the program administrator for the investigation ADR program. Cornell administers the program's day-to-day operations, including handling the logistical matters and working with the parties to select a mediator from Cornell's roster of mediators.
Cornell uses a network of independent and experienced mediators who help the parties find areas of agreement and help them settle their dispute. The mediator is an experienced neutral individual who is mutually selected by the parties. He or she has no stake in the outcome of the mediation or any power to make decisions that may bind either party. The role of the mediator is to facilitate communication between the parties and to provide an environment where the parties have an opportunity to address their differences.
The mediator uses consensus building skills and knowledge of negotiation to help the parties find ways to overcome any misunderstandings and attempt to find areas of agreement.
The mediator does not act as legal counsel or provide legal advice to any party. Each party should consult an attorney for legal advice as such party deems appropriate.
Historically, most post-investigation ADR mediations have occurred at the first stage of the enforcement process (i.e., before an initial enforcement action). I n those cases, the NRC presents the entity or an individual, as applicable, with the opportunity to engage in mediation with the agency before it makes an enforcement decision.
If the entity or the individual elects ADR, Cornell will help the NRC and the entity or the individual, as applicable, to jointly select a mediator.
After the parties select a mediator, the parties, in coordination with the mediator, set a date and place for the mediation.
Typically, the mediator holds a pre-mediation teleconference with the parties to discuss logistical matters or any special needs of either party. During the mediation, the mediator will give the parties an opportunity to discuss their views on the issue. Often, the mediator will meet privately with each party to develop a clear understanding of the party's perspective and explore and assess options. Although the mediator does not have any power to make decisions that may bind either party, he or she may ask questions intended to help the parties assess the merits of their positions, help them converse in a respectful atmosphere, and identify potential settlement options. If the parties reach a settlement agreement during the mediation session, they will typically document the terms of their agreement in writing by developing an agreement in principle
[AIP) document.
The AIP is not enforceable by either party against the other, but it is the basis on which the NRC drafts a confirmatory order [CO), which is a legally binding document used to confirm the commitments made in the AIP. However, if the parties do not reach a settlement agreement, the traditional enforcement process resumes-that is, the enforcement process continues as it would have, had the parties not engaged in ADR. Although the terms of an ADR settlement become publically available through the issuance of the CO, with certain exceptions, the substance of the discussions during the mediation session is confidential regardless of the mediation outcome. The mediator is prohibited from discussing the mediation proceedings, testifying on anyone's behalf concerning the mediation, or submitting a report on the substance of the discussions.
The NRC and the entity or individual, as applicable, equally share the fees and travel expenses of the mediator and any meeting room fees. However, each party is responsible for its own expenses, such as travel, lodging, and legal representation.