Recordkeeping and Reporting Requirements

10 C.F.R. Part ..., Subpart N
in effectEffective: 2024-07-01

10 C.F.R. § 26.709 Applicability.

The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3, except for FFD programs that are implemented under subpart K of this part.

10 C.F.R. § 26.711 General provisions.

(a) Each licensee and other entity shall maintain records and submit certain reports to the NRC. Records that are required by the regulations in this part must be retained for the period specified by the appropriate regulation. If a retention period is not otherwise specified, these records must be retained until the Commission terminates the facility's license, certificate, or other regulatory approval. (b) All records may be stored and archived electronically, provided that the method used to create the electronic records meets the following criteria: (1) Provides an accurate representation of the original records; (2) Prevents the alteration of any archived information and/or data once it has been committed to storage; and (3) Permits easy retrieval and re-creation of the original records. (c) The licensees and other entities specified in § 26.3(a) and, as applicable, (c) and (d), shall inform each individual of his or her right to review information about the individual that is collected and maintained under this part to assure its accuracy. Licensees and other entities shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is documented by licensees and other entities about the individual. (d) Licensees and other entities shall ensure that only correct and complete information about individuals is retained and shared with other licensees and entities. If, for any reason, the shared information used for determining an individual's eligibility for authorization under this part changes or new information is developed about the individual, licensees and other entities shall correct or augment the shared information contained in the records. If the changed or developed information has implications for adversely affecting an individual's eligibility for authorization, a licensee and other entity specified in § 26.3(a) and, as applicable, (c) and (d), who has discovered the incorrect information, or develops new information, shall inform the reviewing official of any FFD program under which the individual is maintaining authorization of the updated information on the day of discovery. The reviewing official shall evaluate the information and take appropriate actions, which may include denial or unfavorable termination of the individual's authorization.

10 C.F.R. § 26.713 Recordkeeping requirements for licensees and other entities.

(a) Each licensee and other entity who is subject to this subpart shall retain the following records for at least 5 years after the licensee or other entity terminates or denies an individual's authorization or until the completion of all related legal proceedings, whichever is later: (1) Records of self-disclosures, employment histories, and suitable inquiries that are required under §§ 26.55, 26.57, 26.59, and 26.69 that result in the granting of authorization; (2) Records pertaining to the determination of a violation of the FFD policy and related management actions; (3) Documentation of the granting and termination of authorization; and (4) Records of any determinations of fitness conducted under § 26.189, including any recommendations for treatment and followup testing plans. (b) Each licensee and other entity who is subject to this subpart shall retain the following records for at least 3 years or until the completion of all related legal proceedings, whichever is later: (1) Records of FFD training and examinations conducted under § 26.29; and (2) Records of audits, audit findings, and corrective actions taken under § 26.41. (c) Licensees and other entities shall ensure the retention and availability of records pertaining to any 5-year denial of authorization under § 26.75(c), (d), or (e)(2) and any permanent denial of authorization under § 26.75(b) and (g) for at least 40 years or until, on application, the NRC determines that the records are no longer needed. (d) Licensees and other entities shall retain any superseded versions of the written FFD policy and procedures required under §§ 26.27, 26.39, and 26.203(b) for at least 5 years or until completion of all legal proceedings related to an FFD violation that may have occurred under the policy and procedures, whichever is later. (e) Licensees and other entities shall retain written agreements for the provision of services under this part for the life of the agreement or until completion of all legal proceedings related to an FFD policy violation that involved those services, whichever is later. (f) Licensees and other entities shall retain records of the background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel, conducted under § 26.31(b)(1)(i), for the length of the individual's employment by or contractual relationship with the licensee or other entity, or until the completion of all related legal proceedings, whichever is later. (g) If a licensee's or other entity's FFD program includes tests for drugs in addition to those specified in this part, as permitted under § 26.31(d)(1), or uses more stringent cutoff levels than those specified in this part, as permitted under § 26.31(d)(3), the licensee or other entity shall retain documentation certifying the scientific and technical suitability of the assays and cutoff levels used, as required under § 26.31(d)(1)(i) and (d)(3)(iii)(C), respectively, for the time the FFD program follows these practices or until the completion of all related legal proceedings, whichever is later.

10 C.F.R. § 26.715 Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services.

(a) Collection sites providing services to licensees and other entities who are subject to this subpart, licensee testing facilities, and HHS-certified laboratories shall maintain and make available documentation of 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. This 2-year period may be extended on written notification by the NRC or by any licensee or other entity for whom services are being provided. (b) Documentation that must be retained includes, but is not limited to, the following: (1) Personnel files, including training records, for all individuals who have been authorized to have access to specimens, but are no longer under contract to or employed by the collection site or licensee testing facility; (2) Chain of custody documents (other than forms recording specimens with negative test results and no FFD violations or anomalies, which may be destroyed after appropriate summary information has been recorded for program administration purposes); (3) Quality assurance and quality control records; (4) Superseded procedures; (5) All test data (including calibration curves and any calculations used in determining test results); (6) Test reports; (7) Records pertaining to performance testing; (8) Records pertaining to the investigation of testing errors or unsatisfactory performance discovered in quality control or blind performance testing, in the testing of actual specimens, or through the processing of appeals and MRO reviews, as well as any other errors or matters that could adversely reflect on the integrity of the testing process, investigation findings, and corrective actions taken, where applicable; (9) Performance records on certification inspections; (10) Records of preventative maintenance on licensee testing facility instruments; (11) Records that summarize any test results that the MRO determined to be scientifically insufficient for further action; (12) Either printed or electronic copies of computer-generated data; (13) Records that document the dates, times of entry and exit, escorts, and purposes of entry of authorized visitors, maintenance personnel, and service personnel who have accessed secured areas of licensee testing facilities and HHS-certified laboratories; and (14) Records of the inspection, maintenance, and calibration of EBTs.

10 C.F.R. § 26.717 Fitness-for-duty program performance data.

(a) Licensees and other entities shall collect and compile FFD program performance data for each FFD program that is subject to this subpart. (b) The FFD program performance data must include the following information: (1) The random testing rate; (2) Drugs for which testing is conducted and cutoff levels, including results of tests using lower cutoff levels, tests for drugs not included in the HHS panel, and any special analyses of dilute specimens permitted under § 26.163(a)(2); (3) Populations tested (i.e., licensee or other entity employees, C/Vs); (4) Number of tests administered and results of those tests sorted by population tested (i.e., licensee or other entity employees, C/Vs); (5) Conditions under which the tests were performed, as defined in § 26.31(c); (6) Substances identified; (7) Number of subversion attempts by type; (8) Summary of management actions; and (9) The information required under § 26.203(e)(1) and (e)(2). (c) Licensees and other entities who have a licensee-approved FFD program shall analyze the data at least annually and take appropriate actions to correct any identified program weaknesses. Records of the data, analyses, and corrective actions taken must be retained for at least 3 years or until the completion of any related legal proceedings, whichever is later. (d) Any licensee or other entity who terminates an individual's authorization or takes administrative action on the basis of the results of a positive initial drug test for marijuana or cocaine shall also report these test results in the annual summary by processing stage (i.e., initial testing at the licensee testing facility, testing at the HHS-certified laboratory, and MRO determinations). The report must also include the number of terminations and administrative actions taken against individuals for the reporting period. (e) Licensees and other entities shall submit the FFD program performance data (for January through December) to the NRC annually, before March 1 of the following year. (f) Licensees and other entities may submit the FFD program performance data in a consolidated report, as long as the report presents the data separately for each site. (g) Each C/V who maintains a licensee-approved drug and alcohol testing program is subject to the reporting requirements of this section and shall submit the required information either directly to the NRC or through the licensees or other entities to whom the C/V provided services during the year. Licensees, other entities, and C/Vs shall share information to ensure that the information is reported completely and is not duplicated in reports submitted to the NRC.

10 C.F.R. § 26.719 Reporting requirements.

(a) Required reports. Each licensee and entity who is subject to this subpart shall inform the NRC of significant violations of the FFD policy, significant FFD program failures, and errors in drug and alcohol testing. These events must be reported under this section, rather than under the provisions of 10 CFR 73.1200. (b) Significant FFD policy violations or programmatic failures. The following significant FFD policy violations and programmatic failures must be reported to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers the violation: (1) The use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area; (2) Any acts by any person licensed under 10 CFR part 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel who are authorized under this part, if such acts— (i) Involve the use, sale, or possession of a controlled substance; (ii) Result in a determination that the individual has violated the licensee's or other entity's FFD policy (including subversion as defined in § 26.5); or (iii) Involve the consumption of alcohol within a protected area or while performing the duties that require the individual to be subject to the FFD program; (3) Any intentional act that casts doubt on the integrity of the FFD program; and (4) Any programmatic failure, degradation, or discovered vulnerability of the FFD program that may permit undetected drug or alcohol use or abuse by individuals within a protected area, or by individuals who are assigned to perform duties that require them to be subject to the FFD program. (c) Drug and alcohol testing errors. (1) Within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing at either a licensee testing facility or an HHS-certified laboratory, in the testing of quality control or actual specimens, or through the processing of reviews under § 26.39 and MRO reviews under § 26.185, as well as any other errors or matters that could adversely reflect on the integrity of the random selection or testing process, the licensee or other entity shall submit to the NRC a report of the incident and corrective actions taken or planned. If the error involves an HHS-certified laboratory, the NRC shall ensure that HHS is notified of the finding. (2) If a false positive error occurs on a blind performance test sample submitted to an HHS-certified laboratory, the licensee or other entity shall notify the NRC within 24 hours after discovery of the error. (3) If a false negative error occurs on a quality assurance check of validity screening tests, as required in § 26.137(b), the licensee or other entity shall notify the NRC within 24 hours after discovery of the error. (d) Indicators of programmatic weaknesses. Licensees and other entities shall document, trend, and correct non-reportable indicators of FFD programmatic weaknesses under the licensee's or other entity's corrective action program, but may not track or trend drug and alcohol test results in a manner that would permit the identification of any individuals.

Starting a business? Corpus forms LLCs in all 50 states and DC.