ML14084A395

Mssa Policy and Procedure 2, Rev. 0, Procedures for Recognizing, Monitoring, and Terminating Specialty Boards Certification Process

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Issue date:	04/21/2014
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Page 1 of 13 Enclosure MSSA Policy and Procedure 2 Revision 0 April 21, 2014 PROCEDURES FOR RECOGNIZING, MONITORING, AND TERMINATING SPECIALTY BOARDS CERTIFICATION PROCESS

1.

PURPOSE:

The purpose of this document is to provide procedures for the Radioactive Materials Safety Branch (RMSB) staff, in the Office of Federal and State Materials and Environmental Management Programs (FSME), to process and evaluate applications from specialty boards. The application evaluation should determine if the specialty boards certification processes satisfy the requirements for recognition by the U.S.

Nuclear Regulatory Commission (NRC). The procedures also provide methods for monitoring the status of recognized board certifications. Finally, these procedures provide guidance for posting the recognized board certifications on the Medical Uses Licensee Toolkit and for posting termination dates, if needed.

2.

BACKGROUND:

On March 30, 2005, the NRC published the final rule, Title 10 of the Code of Federal Regulations (10 CFR) Part 35, 10 CFR Part 35 - Medical Use of Byproduct Material Recognition of Specialty Boards, providing, among other things, the criteria specialty boards have to meet before they can be recognized by the NRC or the Agreement States (Federal Register (FR) 70 FR 16336-16367). The procedures for recognizing specialty boards that meet these criteria are provided in the Procedures section of this document.

The Commission directed the NRC staff, in Staff Requirements Memorandum (SRM)-02-0194, dated February 12, 2003, and SRM-03-0145, dated October 9, 2003, to: (1) implement procedures both for adding new specialty boards to the recognized listing and for removing boards from the recognized list; (2) list the boards meeting the criteria on the NRCs Web site (Medical Uses Licensee Toolkit) rather than in the rule itself; and (3) implement plans, in the specific situation when a medical event may have been due to inadequate radiation safety training, to assess whether the examinations adequately assess such knowledge/skills.

All boards, including those whose certification processes were recognized under the previous rule, were required to apply for recognition, so that the NRC could make a clear regulatory determination that all listed board certifications met the relevant criteria in the revised regulations, as required by the Commission in SRM-02-0194.

CONTACT: FSME/MSSA

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3.

POLICY:

The purpose of this document is to provide guidance on identifying specialty boards with certification processes that meet NRC regulations. It also provides direction on posting the names of the recognized board certifications on the Medical Uses Licensee Toolkit, monitoring their status, and updating the status to provide the date terminating recognition of the board.

4.

ROLES AND RESPONSIBILITIES:

4.1.

Certification Board Reviewer 4.1.1. The certification board reviewer, hereafter referred to as the reviewer, will directly interact with specialty boards to gather the information necessary to determine if their certification processes meet the criteria to be recognized by the NRC.

4.1.2. The reviewer will draft approval, deficiency, abandonment, denial, and/or termination1 letters for management concurrence and signature. The reviewer will have all correspondence between the specialty boards and NRC entered into the NRC Agencywide Documents Access & Management System (ADAMS).

4.2.

Medical Radiation Safety Team (MRST) Leader 4.2.1. The MRST Leader should work with the reviewer to decide whether meeting with a specialty board is necessary.

4.2.2. The MRST Leader should review any correspondence to be sent to specialty boards.

4.2.3. The MRST Leader should ensure that at least once every 5 years, MRST staff verifies that each specialty boards certificates and certification processes have not changed.

4.3.

RMSB Chief The RMSB Chief should review and concur on all correspondence between NRC and specialty boards that need to be signed by the Division Director.

4.4.

Division of Materials Safety and State Agreements (MSSA) Director The MSSA Director should review, concur on, and sign specialty board approval, deficiency, abandonment, denial, and termination letters. Only termination letters need to be reviewed by OGC for no legal objection (NLO) determination.

1 Abandonment letters are sent when new applicants do not submit supporting information to determine if their board certification processes are adequate to meet the appropriate requirements in Part 35.

Termination letters are sent to boards already listed as recognized when they are not in compliance with the appropriate requirements in Part 35.

Page 3 of 13 4.5.

Advisory Committee for Medical Uses of Isotopes (ACMUI)

The ACMUI will be consulted for their opinion on issues with specialty boards, when needed.

5.

PROCEDURES:

5.1.

Applications for Recognition of Specialty Board Certifications 5.1.1. A specialty board requesting recognition should provide, via letter (on its letterhead), a list of sections in 10 CFR Part 35 for which the board wishes to have its certification process(es) recognized.

a.

The letter should include a clear description of the boards requirements for certification. The boards requirements should include a statement that prior to taking the board certification examination, candidates must complete the requirements for training and experience (T&E) required by the section(s) applicable to the type of certification, for which the board is seeking recognition.

If the board permits candidates to complete the board certification examination before the candidate completes the T&E criteria, the board should explain how the examination assesses knowledge and competency required in 10 CFR Part 35 for that specialty.

b.

The letter should provide information explaining how examinations administered by the board assess competency in radiation safety.

c.

The letter of application should be on the boards letterhead, dated and signed by the chief executive officer of the board, or designee.

d.

If the specialty board posts its requirements for certification on the internet, the board should also provide the Web site address.

e.

The board should indicate when the certification program being described for recognition was established (i.e., became effective).

The board should also specify the length of time for which a certification is valid.

Note: Diplomats of the board who, prior to recognition of the board, met the requirements of the program described for recognition can be considered for approval as Authorized Medical Physicists (AMPs),

Authorized Nuclear Pharmacists (ANPs), Authorized Users (AUs), or Radiation Safety Officers (RSOs) via the board certification pathway.

These individuals must meet all the requirements required by NRC for boards certification process recognition and the board must issue them a certificate identical to one submitted to the NRC as evidence that the process meets NRCs requirements for recognition.

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f.

If the certification is conditional on maintaining a certain level of additional T&E, then the board should describe how NRC and the Agreement States will determine if the individual is still board certified.

g.

The letter should include a copy of the certificate(s) with any special terms or phrases that must appear on the certificate(s) and a draft or sample watermark across the text of each certificate(s).

5.1.2. Once the specialty board application is received, the reviewer should enter the complete document into ADAMS and declare the document with the Document Processing Center (DPC) to ensure timely release (i.e., 7 business days) in accordance with NRC policy. Next, the reviewer should enter each sample certificate as a separate file into ADAMS and declare these documents with the DPC to enable posting of the sample certificates on the Medical Uses Licensee Toolkit after the review is complete. The reviewer should then evaluate the procedures and requirements of specialty boards for conferring certifications to determine if they are in accordance with the criteria established in the applicable sections of subparts B and D through H of 10 CFR Part 35 for NRC recognition of specialty board certifications. The requirements for recognition of a boards certification for RSOs appear in § 35.50(a), for AMPs in § 35.51(a), for ANPs in § 35.55(a), and for various classes of AUs in §§ 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a),

35.490(a), 35.590(a) and 35.690(a). Staff should consult with the ACMUI when needed.

5.1.3. When the boards certification process meets the appropriate set of requirements for NRC recognition, the reviewer should notify the board of its finding via letter signed by the MSSA Director and add that board certification to the list of recognized board certifications appearing on the Medical Uses Licensee Toolkit. The information posted on the Medical Uses Licensee Toolkit will include the dates for which the boards certification process is recognized, any special terms or phrases that must appear on the certificate, and a draft or sample copy of the board certificate. The certificate should be posted in a manner that prevents easy electronic copying (i.e. black and white instead of color, poor resolution, Not Valid or Sample dark watermark).

5.1.4. If a boards certification process does not meet the requirements in 10 CFR Part 35, or if there is not enough information to make that determination, the board will be notified and requested to provide additional information via letter signed by the MSSA Director.

5.1.5. If no additional information is received from the board, an abandonment letter signed by the MSSA Director will be sent to the board.

Page 5 of 13 5.1.6. If after additional information is received, the boards certification process still does not meet the applicable criteria in 10 CFR Part 35, the reviewer will notify the board of this finding and denial of recognition via letter signed by the MSSA Director. The reviewer will also notify the Agreement States, via FSME letter, of the name of the board and the date of this determination.

5.1.7. Agreement States may also recognize the certification process(es) of specialty boards that meet the requirements in 10 CFR Part 35. The T&E requirements, including those for board recognition, are Compatibility Category B because of their transboundary implications.

Please see Review Summary Sheets for Regulation Adoption for New Agreement States/Programs (10 CFR 35) at http://nrc-stp.ornl.gov/regsumsheets_newregs.html.

5.1.8. Specialty boards recognized by an Agreement State should also be listed on the Medical Uses Licensee Toolkit. The listing should be annotated to indicate which Agreement State conducted the review.

Note: Typically, the goal for the reviewer to complete a response is within 60 working days from the time all necessary information is received. If no response is received after 30 days of submitting a request for additional information, the request from the specialty board will be voided (this must be specified in the deficiency letter). Approval, deficiency, abandonment, denial, and termination letters must be formally issued and signed.

However, since direct interaction with specialty boards has proven to be effective, phone calls (with documentation), e-mails, and in-person meetings (with summary of the meeting) can be used to resolve deficiencies before specialty boards resubmit their applications. This interaction should be approved by the MRST Leader.

5.2.

Reviewing Applications 5.2.1. The specialty board needs to be a board, not a training course.

5.2.2. Review specific regulations (see section 5.1.2 of this document) and compare the application to the regulations.

a.

If the application addresses the regulations but has a non-specific statement of the regulations, or a statement that reads or equivalent, the certification is not acceptable.

If for example, the NRC asks for four requirements and the board lists a different one substituting for one of the four in our regulations, the certification is not acceptable.

b.

If the board has additional requirements to NRCs that will not supersede our requirements, the certification is acceptable.

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c.

If the board has a T&E pathway that is not in NRCs regulations, the certification is not acceptable.

d.

If the board issues more than one certification, the board must distinguish between the certificates in a manner that provides confidence that the holder of a particular certificate meets our requirements.

e.

If the board requires a test, it must cover what is in NRCs regulations. It may cover more but it cannot cover less than what is in NRCs regulations. The test should be given by a diplomat of the board.

f.

T&E for foreign individuals needs to be carefully evaluated to ensure if they meet preceptor supervised work experience requirements.

5.3.

Requirements for Recognition of a Boards Certification 5.3.1. Educational Requirements (Not All Apply - See Regulations)

a.

Have correct degrees

b.

The degrees must be in the listed specialty areas

c.

The minimum college credits in the appropriate areas must be met

d.

Educational institutions need to be accredited

e.

Pass foreign examination committee test (if applicable)

f.

Residency programs must have correct accreditation

g.

Physicians or pharmacists must hold current, active license to practice 5.3.2. Work Experience Requirements (Not All Apply - See Regulations)

a.

For the correct time period

b.

For the listed disciplines

c.

Supervised experience by an individual certified by a recognized specialty board in the listed discipline is met or supervision by authorized individual is met, as appropriate

d.

Graduate training is substituted by the correct period of required experience, or required T&E

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e.

If training has to be received on specific equipment, the facility has the equipment or sends the individual to a facility that provides the training and supervised work experience on the equipment.

f.

Must include the work experience in all topics listed in the regulations 5.3.3. Training Requirements

a.

For the correct time period

b.

For the listed disciplines

c.

Must include the classroom and laboratory training in all topics listed in the regulations

d.

Supervision by authorized individual is met 5.3.4. Examination Requirements

a.

Pass examination administered by diplomats of the board

b.

Examination must evaluate knowledge and competence in the listed disciplines

c.

If one-part exam is given to address both the educational and work experience, it should be given at the completion of all the T&E.

d.

If multiple tests are given, one may cover the training portion of the requirements and the other cover the work experience component.

The final examination must be after completion of all the T&E.

5.4.

Communications with Specialty Boards 5.4.1. Communications between the NRC staff and specialty boards should be in writing, via letter. Communications to the NRC from a specialty board are to be signed by a person authorized to speak for the board (i.e., its chief executive officer or designee) and mailed on boards letterhead to:

Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs US Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Chief, Radioactive Materials Safety Branch, Mail Stop T-8E24

Page 8 of 13 For delivery services requiring a street address, mail to:

Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs U.S. Nuclear Regulatory Commission 11545 Rockville Pike Rockville, MD 20852-2738 Attention: Chief, Radioactive Materials Safety Branch, Mail Stop T-8E24 5.4.2. Communications would include those sent to the NRC for the purpose of supplying information in support of an application. Change in certification procedures, change in certificates, or other change that would affect recognition of the boards certification process(es) under 10 CFR Part 35 would also be included in these communications.

a.

Letters from the board should acknowledge managements commitments to and responsibility for the completeness and accuracy of the information provided to the NRC.

b.

Letters of recognition to boards should include a request that recognized boards notify the NRC, via letter, 6 months in advance, of: plans for becoming inactive or disbanding; changes to the boards name; the name of its specialty certifications and certification procedures that would affect the recognition of their certification processes; as well as any changes to the certificates.

5.4.3. In accordance with § 2.390, Public inspections, exemptions, requests for withholding, copies of all communications, including enclosures, will be made available electronically for public inspection in the NRC Public Document Room or from ADAMS, accessible at http://www.nrc.gov/reading-rm/adams.html. The board should be informed of these requirements in advance of submitting information and encouraged to not include any personal privacy or proprietary information in communications, to the extent possible, so that they can be made available to the public without redaction. If the board includes personal privacy or proprietary information and the board has not followed the procedures specified in § 2.390(b), the NRC will return to the specialty board any communications containing personal privacy or proprietary information for resubmission.

5.5.

Maintenance of Recognized Status 5.5.1. When the NRC recognizes a boards certification process(es) and notifies the board that its certification(s) will be listed on the Medical Uses Licensee Toolkit, the board will also be advised that it is to notify the NRC, via letter,

Page 9 of 13 6 months in advance, of plans for changes to certification procedures, and changes to its certificate, that would affect recognition of its certification process(es). See section 5.4 of this document on Communications with Specialty Boards.

5.5.2. The reviewer will periodically request, from each board whose certification process(es) has (have) been recognized by the Commission, verification in writing that it has not changed its name, the name of its specialty certifications, and that all changes in its certification procedures, including changes to certificates, that would affect the recognition of its certification(s) have been communicated to the NRC for review. If a board does not respond, the reviewer will investigate the matter. The NRC staff requests to the boards for verifications will be via letter signed by the MSSA Director, at intervals not to exceed 5 years.

5.5.3. The reviewer will evaluate the recognized boards Web site and current certificate for changes that could affect a recognition of the boards certification process(es) every 5 years, using the procedures outlined in section 5.1 of this document, Applications for Recognition of Specialty Board Certifications, and seek the advice of the ACMUI if necessary. The NRC staff will determine if the boards certification procedures continue to meet the applicable criteria for recognition of board certifications, as established in §§ 35.50(a), 35.51(a), 35.55(a), 35.190(a), 35.290(a),

35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a), and notify the board regarding its findings via letter signed by the MSSA Director.

5.5.4. The Agreement State which initially recognizes a boards certification process(es) will be responsible for determining that boards continued eligibility for recognition.

5.6.

Procedures for Terminating Recognition of Specialty Boards 5.6.1. Termination based on inadequate evaluation of radiation safety competency of candidates for certification:

a.

The reviewer will monitor trends in medical events and escalated enforcement actions. If a trend in medical events or escalated enforcement actions for a particular specialty is attributable to inadequate radiation safety competence, the staff will determine, in consultation with the ACMUI, if the trend is associated with a deficiency in the evaluation of the individuals qualifications. This deficiency must be traceable to inadequacies in a specialty boards certification process, including requirements for T&E related to radiation safety. If the trend is determined to be attributable to inadequate radiation safety competence that is not identified through the certification process, the reviewer will assess whether the examinations provided by the certifying board adequately assess the knowledge/skills reflected in the requirements for T&E related to recognition of the specialty boards certification process.

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b.

If the reviewer determines that changes in evaluation of the radiation safety competence of candidates for certification by a specialty board are necessary in order for the board to maintain recognition of its certification process(es), the board will be advised of this determination. Once signed by the MSSA Director, the reviewer will send a request to the board to provide a description of any changes the board would propose to make, in order to maintain recognition of its certification processes by the NRC, and to identify reasons for disagreeing with NRC findings, if this is the case. The NRC staff will use the procedures discussed under section 5.1.1 of this document as a guide in this process.

c.

If the board fails to respond or if, after reviewing the boards response, changes to certification requirements are still necessary and the specialty board takes no action to address NRCs concerns, a date terminating recognition of that specialty board will be added to the Medical Uses Licensee Toolkit.

d.

The Commission and the ACMUI will be informed of any decision by the NRC staff to terminate recognition of a boards certification.

e.

The reviewer will notify the board that this action has been taken, and advise the board that it may supply new information for review by the NRC staff. This information will be used to determine if the boards procedures are adequate to resolve NRCs concerns. This notification will be via letter (termination letter) signed by the MSSA Director with NLO determination from OGC.

f.

When a boards recognition is terminated by the NRC or an Agreement State due to an identified deficiency in its requirements for the certification process, the reviewer will determine the date when the inadequacy developed, beyond which the certification will no longer be recognized. That termination date will be posted on the Medical Uses Licensee Toolkit listing for that boards certification.

g.

When a boards certification process is recognized by an Agreement State, that State shall be responsible for assessing inadequate evaluation of radiation safety competency of candidates for certification, for terminating recognition for that boards certification(s), and for notifying the NRC.

5.6.2. Termination based on change in the certification process:

a.

If an instituted or proposed change in the certification process(es) of a recognized board may adversely affect the recognized status of the boards certification process(es), the board will be advised. The board will be requested to provide information to support continuation of NRC recognition of the boards certification process(es) via letter signed by the MSSA Director. The ACMUI should be informed of this determination and request for information.

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b.

If the board fails to respond or if, after reviewing the boards response, changes to certification requirements are still necessary and the specialty board takes no action to address NRCs concerns, then that specialty boards certification(s) recognition will be terminated.

c.

The board will be notified of this action, and advised that it may supply new information to determine if its procedures are adequate to resolve NRCs concerns. This notification will be via letter (termination letter) signed by the MSSA Director with NLO determination from OGC.

d.

The Commission and the ACMUI will be informed of an NRC staff determination that a boards certification(s) recognition is to be terminated.

e.

If a board is terminated by the NRC or an Agreement State due to inadequacy of its certification process requirements, the reviewer will determine the date when the inadequacy developed, beyond which the certification will no longer be recognized. That termination date will be posted on the Medical Uses Licensee Toolkit listing for that board.

f.

When a boards certification process is recognized by an Agreement State, that State shall be responsible for assessing inadequate evaluation of radiation safety competency of candidates for certification, for terminating recognition for that boards certification(s), and for notifying the NRC.

5.6.3. Termination based on a board becoming inactive or disbanding:

a.

If the NRC staff becomes aware that a board has or intends to become inactive or disband, the staff will attempt to contact the board. The reviewer will request, via letter signed by the MSSA Director, that the board provides information confirming whether the board has become inactive or disbanded, or intends to become inactive or disband. The reviewer will request an explanation of why the change should not result in withdrawal of NRC recognition of the boards certification process(es).

b.

If the board fails to respond or if, after reviewing the boards response, the reviewer still believes that the board has changed its status and that this change should result in withdrawal of NRCs recognition of the boards certification process(es), then a date terminating recognition of certification will be added to NRCs list of recognized board certifications.

c.

The Commission and the ACMUI will be informed of a staff decision to terminate recognition of a boards certification.

d.

The NRC will notify the board that this action has been taken, and advise the board that it may supply new information to determine if

Page 12 of 13 its procedures are adequate to resolve NRCs concerns. This notification will be via letter (termination letter) signed by the MSSA Director.

e.

If a boards certification recognition is terminated by the NRC or an Agreement State due to the board becoming inactive or disbanding, the reviewer will determine the effective date of this change in status and the date when the certification is no longer to be recognized.

Information about the dates for which the boards certification was recognized and the termination date will be posted on the Medical Uses Licensee Toolkit.

f.

When a board is granted recognition by an Agreement State, that State shall be responsible for monitoring the status of the board, for taking action to terminate recognition of a boards certification(s) if the board becomes inactive or disbands, and for notifying the NRC.

5.7.

Evaluation of Training and Experience - Outdated Certifications and Certificates If an individual holds a certification from a board for which the NRC or an Agreement State terminates recognition of the boards certification process, the certification will be considered valid if it was granted during the time interval that the boards certification process was recognized. The reviewer will annotate the listing of board certifications on the Medical Uses Licensee Toolkit to indicate the effective dates of recognition of board certifications, including the date(s) of termination and date(s) through which certifications were recognized. If the certificate changes, the listing will also indicate the length(s) of time for which the particular board certificate is valid.

Note: The recentness of training requirements contained in 10 CFR 35.59 must also be satisfied.2

6.

REFERENCES:

SRM-02-0194, dated February 12, 2003 SRM-03-0145, dated October 9, 2003 70 FR 16336-16367, dated March 30, 2005 71 FR 1926, dated January 12, 2006 Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35:

http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html 2 The reviewer will identify, from the group certified by a specialty board, the individuals that meet NRCs regulations for recognition.

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7.

DOCUMENT HISTORY:

Version Description of Change Responsible Division Date Last Modified 0

Initial Procedure MSSA April 21, 2014