10 CFR 26.135, Split Specimens

Split specimens

a

(a) If the FFD program follows split-specimen procedures, as described in § 26.113, the licensee testing facility shall analyze aliquots of the specimen for the licensee's or other entity's purposes as described in this part. Except as provided in paragraph (b) in this section, the licensee testing facility shall store Bottles A and B of the specimen in a secure manner until the facility has finished testing. If the initial validity and drug test results are negative and the specimen in Bottle A will not be forwarded to the HHS-certified laboratory, the licensee testing facility may discard both Bottle A and Bottle B. If any test results are positive or indicate that the specimen is of questionable validity, the licensee testing facility shall forward Bottle A to the HHS-certified laboratory for testing and shall retain Bottle B in secure storage, under the requirements of § 26.159(i), or may forward it to the HHS-certified laboratory for storage.

b

(b) If the MRO confirms any positive, adulterated, or substituted result for a specimen in Bottle A, based on the results of confirmatory testing at an HHS-certified laboratory, and the licensee testing facility has elected to retain Bottle B of the specimen, and the donor requests testing of the specimen in Bottle B, as permitted under § 26.165(b), the MRO shall ensure that Bottle B is forwarded to an HHS-certified laboratory other than the laboratory that tested the specimen in Bottle A, under the procedures specified in § 26.165(b).

c

(c) If the MRO confirms that the specimen in Bottle A is positive, adulterated, substituted, or invalid and the donor does not request that Bottle B be tested, the licensee or other entity shall ensure that Bottle B is maintained in long-term, frozen storage (- 20 °C/-68 °F or less) for a minimum of 1 year. If a licensee testing facility elects to retain the specimen in Bottle B, rather than forwarding it to the HHS-certified laboratory with Bottle A, the licensee testing facility shall ensure proper storage conditions in the event of a prolonged power failure. After the end of 1 year, the licensee or other entity may discard Bottle B, with the exception that the licensee testing facility shall retain any specimens under legal challenge, or as requested by the NRC, until the specimen is no longer needed.

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v t e Code of Federal Regulations
Title 10 Part 26 - FITNESS FOR DUTY PROGRAMS
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, Administrative Provisions, Purpose 3, Scope 4, FFD program applicability to categories of individuals 5, Definitions 7, Interpretations 8, Information collection requirements: OMB approval 9, Specific exemptions 11, Communications 21, Program Elements, Fitness-for-duty program 23, Performance objectives 25, Reserved 27, Written policy and procedures 29, Training 31, Drug and alcohol testing 33, Behavioral observation 35, Employee assistance programs 37, Protection of information 39, Review process for fitness-for-duty policy violations 41, Audits and corrective action 51, Granting and Maintaining Authorization, Applicability 53, General provisions 55, Initial authorization 57, Authorization update 59, Authorization reinstatement 61, Self-disclosure and employment history 63, Suitable inquiry 65, Pre-access drug and alcohol testing 67, Random drug and alcohol testing of individuals who have applied for authorization 69, Authorization with potentially disqualifying fitness-for-duty information 71, Maintaining authorization 73, Management Actions and Sanctions To Be Imposed, Applicability 75, Sanctions 77, Management actions regarding possible impairment 81, Collecting Specimens for Testing, Purpose and applicability 83, Specimens to be collected 85, Collector qualifications and responsibilities 87, Collection sites 89, Preparing to collect specimens for testing 91, Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use 93, Preparing for alcohol testing 95, Conducting an initial test for alcohol using a breath specimen 97, Conducting an initial test for alcohol using a specimen of oral fluids 99, Determining the need for a confirmatory test for alcohol 101, Conducting a confirmatory test for alcohol 103, Determining a confirmed positive test result for alcohol 105, Preparing for urine collection 107, Collecting a urine specimen 109, Urine specimen quantity 111, Checking the acceptability of the urine specimen 113, Splitting the urine specimen 115, Collecting a urine specimen under direct observation 117, Preparing urine specimens for storage and shipping 119, Determining "shy" bladder 121, Licensee Testing Facilities, Purpose 123, Testing facility capabilities 125, Licensee testing facility personnel 127, Procedures 129, Assuring specimen security, chain of custody, and preservation 131, Cutoff levels for validity screening and initial validity tests 133, Cutoff levels for drugs and drug metabolites 135, Split specimens 137, Quality assurance and quality control 139, Reporting initial validity and drug test results 151, Laboratories Certified by the Department of Health and Human Services, Purpose 153, Using certified laboratories for testing urine specimens 155, Laboratory personnel 157, Procedures 159, Assuring specimen security, chain of custody, and preservation 161, Cutoff levels for validity testing 163, Cutoff levels for drugs and drug metabolites 165, Testing split specimens and retesting single specimens 167, Quality assurance and quality control 168, Blind performance testing 169, Reporting Results 181, Determining Fitness-for-Duty Policy Violations and Determining Fitness, Purpose 183, Medical review officer 185, Determining a fitness-for-duty policy violation 187, Substance abuse expert 189, Determination of fitness 201, Managing Fatigue, Applicability 203, General provisions 205, Work hours 207, Waivers and exceptions 209, Self-declarations 211, Fatigue assessments 401, FFD Programs for Construction, General 403, Written policy and procedures 405, Drug and alcohol testing 406, Fitness monitoring 407, Behavioral observation 409, Sanctions 411, Protection of information 413, Review process 415, Audits 417, Recordkeeping and reporting 419, Suitability and fitness evaluations 709, Recordkeeping and Reporting Requirements, Applicability 711, General provisions 713, Recordkeeping requirements for licensees and other entities 715, Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services further results Appendices:

10 CFR 26.135, Split Specimens

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b

c

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10 CFR 26.135, Split Specimens

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c

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