Frequently Asked Questions About Recordkeeping
This section provides the NRC staff's answers to the following questions related to recordkeeping, as it relates to fitness-for-duty:
With the elimination of the permanent record book from the new 10 CFR Part 26, would a licensee still need to maintain the old ones and, if so, for how long?
Under the 1989 FFD rule, collection site personnel were required to maintain a permanent record book that identified data on each specimen collected at a collection site in the sequence of collection. The 1989 FFD rule instructed collection site personnel to record any unusual circumstances (e.g., donor's behavior or appearance, specimen color, evidence of contaminants) in the permanent record book. Although the 2008 revisions to 10 CFR Part 26 eliminated requirements regarding recording collector comments on specimen collections in a "permanent record book," a licensee should continue to retain any permanent record books (or equivalent records) in accordance with §26.715(a) of the March 31, 2008, rule. This section of the rule requires collection sites to maintain documentation on all aspects of the testing process for at least 2 years or until the completion of all legal proceedings related to a determination of an FFD violation, whichever is later.
Section 26.153(g) states that "If licensees or other entities use a form other than the current Federal custody-and-control form, licensees and other entities shall provide a memorandum to the laboratory explaining why a non-Federal form was used…" Should this be interpreted to mean that use of the Federal form is optional and a licensee may provide a blanket memorandum to the laboratory indicating that they have decided to use a non-Federal form that contains all of the required elements or is use of the Federal form a requirement and the occasional use of a non-federal form must be documented with a memorandum on an individual basis, i.e. each time a non-compliant form is used?
Licensees or other entities that enter into contracts with HHS-certified laboratories must require the laboratory to implement all applicable Part 26, Subpart G requirements (see § 26.153(f)). These contact discussions could include the use of a one-time memorandum (i.e., a standing memorandum for the record, identified as a regulated sample by account number) to the HHS-certified laboratory that states the licensee/entity will use a non-Federal form for all specimen collections. However, the memorandum must explain why the non-Federal form was used and licensees/entities are required to ensure that the form used contains all required elements in the Federal form. See HHS Guidelines, Section 6.2, for addition guidance if the Federal form is not available or not used by the licensee or other entity testing program for specimen collection.
Do the records required by 10 CFR 26 (e.g., §§ 26.203(d), 26.713, and 26.715) meet the definition of Quality Assurance Records specified in 10 CFR Part 50, Appendix B, Criterion XVII?
The only Part 26 records that are considered Quality Assurance Records under Part 50, Appendix B, Criterion XVII are those required by § 26.205(e)(4), which requires licensees to record, trend, and correct under the licensee's corrective action program any problems identified in maintaining control of work hours consistent with the specific requirements and performance objectives of Part 26.
Section 26.35(c)(1)(ii) requires Employee Assistance Programs (EAP) to report acts reportable under § 26.719(b)(1) through (b)(3). Is there a more detailed explanation of § 26.719 regarding the balance between privacy rights and the need to report such information?
The staff provided additional information on page 17026 of the final rule's Federal Register notice (Vol. 73, No. 62 / March 31, 2008) which can be viewed at http://edocket.access.gpo.gov/2008/pdf/E8-4998.pdf.
Do the requirements in sections 26.715(b)(5) and (6) regarding the maintenance of test data and test reports apply to all printed breath test results provided under section 29.91(c)(1)? Or does section 26.715(b)(2) permit licensees to destroy test data and reports associated with negative results with no FFD violations or anomalies, after appropriate summary information has been recorded for program administration purposes?
Per sections 26.715(b)(5) and (6), licensees are required to maintain all test data and reports for two years or until the completion of all proceedings related to FFD investigations, test results, appeals, MRO reviews, etc (see section 26.715(b)(8)), whichever is later. This includes printed results of breath tests. Section 26.715(b)(2) states that chain-of-custody documents recording specimens with negative test results and no FFD violations or anomalies may be destroyed after appropriate summary information has been recorded. This exception to the two-year document maintenance requirement applies to chain-of-custody documents only. The Fitness-for-Duty final rule defines chain of custody as "procedures to account for the integrity of each specimen or aliquot by tracking its handling and storage from the point of specimen collection to final disposition of the specimen and its aliquots." The breath test results required under section 26.91(c)(1) are not chain-of-custody documents, as their purpose is not to track the handling and storage of the specimen or aliquot. Thus, licensees must maintain all test data and reports in accordance with sections 26.715(b)(5) and (6) regardless of the test result.
Subpart N of 10 CFR Part 26 contains an applicability statement in § 26.709. Unlike other Applicability statements throughout Part 26, § 26.709 does not make reference to the sub-sections of § 26.3 it applies to. Also, § 26.711(a) discusses licenses, certificates, and NRC approvals, none of which apply to an approved contractor/vendor (C/V).
Since § 26.709 references licensees and other entities and does not mention C/Vs, does the overall scope of applicability for Subpart N not apply to C/V programs?
As defines in § 26.5, "other entity" is defined as follows:
Other entity means any corporation, firm, partnership, limited liability company, association, C/V, or other organization who is subject to this part under § 26.3(a) through (c), but is not licensed by the NRC.
The applicability statement in § 26.709 states that the requirements of Subpart N apply to the FFD programs of licensees and other entities. Because C/Vs are included in the definition of "other entity," Subpart N applies to C/Vs.