7920 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices

DEPARTMENT OF HEALTH AND Order No. 12564, has established the Summary of Public Comments and HUMAN SERVICES scientific and technical guidelines for HHS’s Response federal workplace drug testing programs The following comments were Substance Abuse and Mental Health and established standards for directed to the information and Services Administration certification of laboratories engaged in questions in the preamble. urine drug testing for federal agencies. Mandatory Guidelines for Federal As required, HHS originally published Costs and Benefits Workplace Drug Testing Programs the Mandatory Guidelines for Federal The Department requested comments AGENCY: Substance Abuse and Mental Workplace Drug Testing Programs on costs and benefits. One commenter Health Services Administration (Guidelines) in the Federal Register disagreed that the cost increase for (SAMHSA), HHS. [FR] on April 11, 1988 [53 FR 11979]. laboratories to add analytes to regulated ACTION: Revised Mandatory Guidelines The Substance Abuse and Mental testing will be minimal, stating that by the Secretary of Health and Human Health Services Administration significant costs would be incurred for Services. (SAMHSA) subsequently revised the information technology (IT) Guidelines on June 9, 1994 [59 FR development, as well as incremental SUMMARY: The Department of Health and 29908], September 30, 1997 [62 FR costs for additional immunoassays (if Human Services (‘‘HHS’’ or 51118], November 13, 1998 [63 FR required); for additional calibrators, ‘‘Department’’) has revised the 63483], April 13, 2004 [69 FR 19644], controls, and internal standards; and for Mandatory Guidelines for Federal and November 25, 2008 [73 FR 71858] increased confirmatory testing costs Workplace Drug Testing Programs with an effective date of May 1, 2010 (including data review and result (Guidelines), 73 FR 71858 (November (correct effective date published on certification) based on an expected 25, 2008) for urine testing. December 10, 2008; [73 FR 75122]). The increased positivity rate for opioids. DATES: Effective Date: October 1, 2017. effective date of the Guidelines was One commenter disagreed with the FOR FURTHER INFORMATION CONTACT: further changed to October 1, 2010 on Department’s estimated 3% cost Charles LoDico, M.S., F–ABFT, Division April 30, 2010 [75 FR 22809]. increase for Medical Review Officers of Workplace Programs, Center for The proposed Mandatory Guidelines (MROs) and estimated that the increase Substance Abuse Prevention (CSAP), for Federal Workplace Drug Testing will be 10%. The commenters did not SAMHSA mail to: 5600 Fishers Lane, Programs using Urine (UrMG) published provide any substantive evidence or Room 16N03A, Rockville, MD 20857, in the Federal Register on May 15, 2015 data to support these comments. The telephone (240) 276–2600 or email at (80 FR 28101) include revisions to the Department recognizes that there will be [email protected]. initial and confirmatory drug test start-up costs to laboratories to SUPPLEMENTARY INFORMATION: In analytes and methods for urine testing, implement testing for the additional particular, these revised Mandatory the cutoff for reporting a urine specimen analytes for regulated specimens Guidelines for Federal Workplace Drug as adulterated based on low pH, and the including administrative costs, and Testing Programs using Urine (UrMG) requalification requirements for agrees that the estimated increased costs allow federal executive branch agencies individuals serving as Medical Review for some MROs may exceed the 3% to test for additional Schedule II drugs Officers (MROs) and, where appropriate, estimate. The Department’s cost analysis of the Controlled Substances Act (i.e., include references to the use of an was based on information provided by oxycodone, oxymorphone, hydrocodone alternate specimen in federal workplace multiple HHS-certified laboratories and and hydromorphone) in federal drug- drug testing programs. References to an MROs, as well as the estimated number free workplace programs, remove alternate specimen are not applicable of additional positives resulting from methylenedioxyethylamphetamine until final Guidelines are implemented the inclusion of the new opioid (MDEA) from the authorized drugs in for the use of the alternative specimen analytes. Costs are expected to vary Section 3.4, add matrix. The Department published a among individual laboratories and methylenedioxyamphetamine (MDA) as separate Notice in the May 15, 2015 MROs, depending on their processes an initial test analyte, raise the lower pH Federal Register (80 FR 28054) and testing populations. Additional cutoff from 3 to 4 for identifying proposing Mandatory Guidelines for information on the estimated costs specimens as adulterated, require MRO Federal Workplace Drug Testing associated with these Guidelines is requalification training and re- Programs using Oral Fluid (OFMG) to included under Regulatory Impact and examination at least every five years allow federal agencies to collect and test Notices below. oral fluid specimens in their workplace after initial MRO certification, and Proposed New Analytes: Oxycodone, allow federal agencies to authorize drug testing programs. There was a 60- day public comment period for both Oxymorphone, Hydrocodone, and collection of an alternate specimen (e.g., Hydromorphone oral fluid) when a donor in their Federal Register Notices, during which program is unable to provide a sufficient 125 commenters submitted comments Seven commenters specifically agreed amount of urine specimen at the on the proposed changes to the with the addition of these drugs to the collection site. Many of the wording Guidelines. These commenters were Guidelines. Two commenters expressed changes and reorganization of the UrMG comprised of individuals, organizations, concerns over the added drugs, were made for clarity, to use current and private sector companies. The indicating that individuals who follow scientific terminology or preferred comments are available for public view their physician’s treatment plan of grammar, and for consistency with the at http://www.regulations.gov/. All taking legally prescribed medication OFMG. comments were reviewed and taken into would produce positive tests, leading to consideration in the preparation of the greater reliance on MROs to determine Background revised Guidelines. The issues and whether tests are truly positive (as a The Department of Health and Human concerns raised in the public comments result of illegal use) or are positive due Services (HHS), by the authority of for the UrMG are set out below. Similar to prescribed usage of the drugs, and a Section 503 of Public Law 100–71, 5 comments are considered together in the greater number of workers will be U.S.C. Section 7301, and Executive discussion. subject to scrutiny and their medical

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records examined at length. One of the the hydrocodone and hydromorphone will not be included in the Guidelines. commenters maintained that such initial test cutoff to 100 ng/mL, to The Department has removed references testing would exceed the legal mandate equate the detection times for these to MRO training entities in Sections under Executive Order No. 12564 and drugs. One commenter requested that 13.2 and 13.3, because training the promulgation of scientific the Department provide the justification documentation is maintained by MRO Guidelines by HHS pursuant to it. The and data used to determine the cutoff certification entities. The Department Guidelines include requirements to levels for the added opioids. The agrees with the comment that MROs protect individuals’ privacy while Department raised the oxycodone and should receive training on revisions to maintaining public safety, including oxymorphone confirmatory test cutoffs the Guidelines, and has added item procedures for MRO review to verify to 100 ng/mL as described above. The Section 13.3(b) to require such training legitimate drug use and maintain the Department has evaluated the comments prior to the effective date of revised confidentiality of donor drug testing and has concluded that no further Guidelines. records. The Department provides change is needed. The selection of additional guidance in the Medical cutoff concentration is not based solely Discussion of Sections Review Officer Manual for Federal on the factor of detection times and The Department has not included a Workplace Drug Testing Programs. The must take into consideration a variety of discussion in the preamble of any inclusion of these additional drugs in factors, both pharmacological and sections for which public comments the Guidelines is within the scope of the chemical. Drug potency, disposition in were not submitted or where minor Department’s regulatory authority to test urine, impact and prevalence must be typographical or grammatical changes for illegal drug use under Section considered. For example, oxycodone is were made. 503(a)(1)(A)(ii)(II) of Public Law 100–71 approximately twice as potent as and Executive Order No. 12564. hydrocodone and may be prescribed in Subpart A—Applicability lower doses, thus a cutoff lower than New Analytes—Cutoff Concentrations 1.5 What do the terms used in these that for hydrocodone is warranted. Guidelines mean? Eight commenters addressed the Therefore, in selecting the cutoffs, the One commenter disagreed with the proposed cutoffs for the added drugs: Department considered the detection definition for ‘‘dilute specimen’’ Three commenters agreed with the times of equipotent doses as well as because it does not include numerical proposed cutoffs; four disagreed with dispositional patterns of each drug in values for creatinine and specific the cutoffs for one or more of the added urine. Data on the disposition of gravity. The Department has concluded drugs. Of these, three commenters stated hydrocodone and oxycodone in urine that the cutoffs are too low: Two of following administration of a single that no change is needed; the analytical these commenters believe that these dose can be found in two recently (numerical) criteria for a dilute cutoffs will unnecessarily identify published scientific articles.12 specimen are provided in Section 3.8. workers using prescription drugs and One commenter requested that one commenter noted that these cutoffs Medical Review Officer (MRO) ‘‘external service provider’’ be defined, will affect accurate quantitation in Requalification—Continuing Education because this is a new term included in routine specimens. The Department Units (CEUs) the proposed Guidelines. The recognizes that the added analytes will The Department requested comments Department agrees and has added the result in an increased number of on requiring MRO requalification definition. positive opioid results requiring MRO continuing education units (CEUs) and The Department has added the review, and has incorporated on the optimum number of credits and definition for ‘‘gender identity’’ to requirements for MRO requalification the appropriate CEU accreditation Section 1.5. This term is now used in and retraining at least every five years. bodies should CEUs be required as part Guidelines sections addressing observed Additional guidance and information on of MRO requalification. Three and monitored collections as described the added drugs will be provided in the commenters agreed with requiring MRO in this preamble under Sections 4.4, 8.1, Medical Review Officer Guidance recertification, but disagreed with the 8.10, and 8.12. Gender identity means Manual for Federal Workplace Drug addition of CEU requirements to the an individual’s internal sense of being Testing Programs. The Department Guidelines. Two commenters disagreed male or female, which may be different disagrees that the cutoffs will affect with specifying the number of CEUs from an individual’s sex assigned at accurate quantitation in routine required. Two commenters indicated birth. specimens. Information from HHS- that certification entities already enforce Two commenters disagreed with the certified laboratories indicates that training requirements and proposed definition for ‘‘invalid result’’ testing at these cutoffs can be recommended that acceptance of CEUs which indicated that an invalid result accomplished with current be handled by MRO certification boards, was reported only when an HHS- instrumentation. However, the not the Department. Two commenters certified laboratory could not complete Department has raised the confirmatory recommended a requirement of annual testing or obtain a valid drug test result. test cutoffs for oxycodone and CEUs: One suggested 16 CEUs and the The Department agrees with the oxymorphone from 50 ng/mL to 100 ng/ other recommended three CEUs. One commenters and has reinstituted the mL. These higher cutoffs are supported commenter recommended 12 CEUs definition from the Guidelines effective by a single dose study which showed prior to initial certification, eight CEUs October 1, 2010 (73 FR 71858). similar detection rates for oxycodone every five years, and also recommended To address comments described in and oxymorphone using either a 50 ng/ two CEUs related to the new this preamble under Section 13.1, the mL or 100 ng/mL cutoff.1 Use of the 100 requirements/topics within two years of Department deleted the definition for ng/mL confirmatory test cutoffs is implementation of the revised ‘‘non-medical use of a drug.’’ expected to be less analytically Guidelines. The Department has Two commenters found the definition challenging for laboratories. evaluated the comments and has of ‘‘specimen’’ confusing, because the One commenter suggested changing concluded that requirements for term ‘‘sample’’ used in the definition the oxycodone and oxymorphone initial continuing education units will remain was also defined as a representative test cutoff to 300 ng/mL and changing with the MRO certification entities and portion of a donor’s specimen. The

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Department agrees, and has reinstituted 1.8 What are the potential 3.3 May any of the specimens be used some wording for the definition of consequences for refusing to take a for other purposes? ‘‘specimen’’ from the Guidelines federally regulated drug test? effective October 1, 2010 (73 FR 71858) Section 3.3 states that specimens The Department reworded Section for clarity. collected pursuant to Executive Order 1.8(b) to clarify that the requirements in 12564, Public Law 100–71, and these 1.6 What is an agency required to do this section apply to donors who fail to Guidelines may not be used for to protect employee records? appear at the collection site in a purposes other than drug and validity One commenter suggested that the reasonable time for any test (except a testing in accordance with Subpart C of non-applicability of the Health pre-employment test), as described in the Guidelines. One commenter Insurance Portability and Section 1.7(a)(1). disagreed with prohibiting employees Accountability Act (HIPAA) and the Subpart B—Urine Specimens from using their drug test specimens for Health Information Technology for other purposes (e.g., deoxyribonucleic Economic and Clinical Health Act 2.1 What type of specimen may be acid, DNA, testing). The Department has (HITECH) should be clearly stated in the collected? evaluated this comment and has Guidelines. The Department has Two commenters requested concluded that no change is needed. evaluated the comment and has clarification on the collection/testing While the Guidelines do not authorize concluded that the applicability of scenario where the federal agency the release of urine specimens, or HIPAA and other relevant privacy laws authorizes collection of an oral fluid portions thereof, to federal employees, is clearly stated in Section 1.6. specimen, but the contracted laboratory the Guidelines afford employees a Accordingly, except for minor does not perform oral fluid testing. The variety of protections that ensure the rewording for clarity, no further Department has evaluated the comments identity, security and integrity of their revisions are necessary. and has concluded that no change is specimens. For example, see Sections 1.7 What is a refusal to take a federally needed. This will be addressed in the 8.5(b), 8.8, and 15.1(a). regulated drug test? federal agency plan. In addition, under Public Law 100– 71, Section 503(a)(1)(A)(ii)(I), HHS is One commenter noted that, per 2.2 Under what circumstances may a mandated to establish ‘‘strict procedures Sections 8.4(c) and 8.9(b), when a urine specimen be collected? collector finds an adulterant or governing the chain of custody of One commenter suggested that the specimens collected for drug testing substitution product or observes an cost of mandatory random drug and attempt to substitute a urine specimen, . . . .’’ Sections 11.7(a) and 11.20(a) alcohol testing among airline pilots this prompts a direct observed also provide that an ‘‘HHS-certified outweighs the benefit. The Department collection, not a refusal to test. The laboratory must control access to the has evaluated the comment and has commenter suggested bringing an drug testing facility, specimens, concluded that no change is needed. adulterant or a substitution product to aliquots, and records,’’ and must retain Airline pilots are subject to drug and the collection should be a refusal to test. specimens that, among other things, alcohol testing under DOT regulations. The Department has evaluated the have been reported ‘‘drug positive’’ for Therefore, this public comment is not comment, and agrees that the collector a minimum of one year. Therefore, the relevant to the Guidelines. In regard to must report a refusal to test when a release of specimens to employees, or to drug testing of federal agency employees donor brings materials for adulterating, an employee’s designee, is inconsistent and applicants, each federal agency substituting, or diluting the specimen to with the mandates of the federal drug establishes its agency plan based on its the collection site, or when the collector testing process, and could significantly mission, its employees’ duties, and the observes a donor’s clear attempt to compromise a specimen’s integrity, potential consequences to the public tamper with a specimen. The security, and an HHS-certified health and safety or national security Department has revised Sections 1.7, laboratory’s ability to fulfill its that could result from the failure of an 8.3(h), 8.4(c), and 8.9(b) accordingly. regulatory duties under the Guidelines. One commenter noted that the employee to adequately perform their One commenter requested further collector does not report a refusal to test duties and responsibilities. clarification of the phrase ‘‘unless when a donor leaves the collection site Subpart C—Urine Specimen Tests authorized in accordance with before the collection process begins for [applicable] federal law’’ in Section 3.3. a pre-employment test. The commenter 3.1 Which tests are conducted on a The phrase ‘‘unless otherwise recommended defining the beginning of urine specimen? authorized in accordance with the pre-employment test collection One commenter suggested changing applicable law in Section 3.3(a) does not process as the point at which the donor the term ‘‘opiates’’ to ‘‘opioids’’ in the represent a significant change from the is asked to present photo identification. Guidelines. The Department agrees with intent of the prior Guidelines language. The Department agrees with the the commenter and has changed the Section 3.3, among others, is intended suggestion to define the beginning of the term ‘‘opiates’’ to ‘‘opioids’’ where to prohibit the use of specimens for collection process specifically for this appropriate to refer to oxycodone, purposes other than those specifically situation. However, the Department has oxymorphone, hydrocodone, and authorized by the Guidelines. However, designated the beginning as the step hydromorphone in addition to codeine, there may be circumstances in which described in Section 8.4(a), when the morphine, and 6-acetylmorphine (6- federal law authorizes an HHS-certified collector provides or the donor selects a AM). laboratory to handle a specimen in a specimen collection container. The manner that differs from the Guidelines. Department has revised Sections 3.2 May a specimen be tested for Therefore, the phrase ‘‘unless 1.7(a)(2) and (3) to include a reference additional drugs? authorized in accordance with to this section. All subsequent items in The Department reworded Section applicable federal law’’ in Section 3.3 of Section 1.7(a) (i.e., items 4–13) apply 3.2(a) to clarify the additional drug tests the Guidelines is intended to avoid once the donor has arrived for the pre- that may be performed on federal conflict with other applicable federal employment test collection. employee specimens. law.

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It should be noted that Section 3.3 methods using an alternate technology with a low-reacting drug, other analytes specifically prohibits conducting or, alternatively, require the combined may exhibit high cross-reactivity, deoxyribonucleic acid (DNA) testing on cross-reactivity of low-reacting leading to false initial test positives. urine specimens, unless authorized in compounds (e.g., hydrocodone and Two of these commenters also noted accordance with applicable federal law. hydromorphone for an opiate assay; that this may result in possibly different MDA and MDEA for an amphetamines 3.4 What are the drug test cutoff cross-reactivity profiles for some assay) to be equal to or greater than the concentrations for urine? structurally unrelated and cutoff. The other commenter concomitantly used prescription and/or The Department proposed recommended not allowing methods over the counter drugs. One commenter methylenedioxyamphetamine (MDA) other than immunoassay for urine initial noted that the option to ‘‘include a and methylenedioxyethylamphetamine testing. One commenter stated that control containing the lowest reacting (MDEA) as initial test analytes. Three cross-reactivity specifications for analyte at its cutoff concentration in commenters disagreed with the addition hydromorphone are not necessary, each batch’’ was described in the of MDA and MDEA as target analytes, based on their non-regulated testing preamble to the proposed Guidelines, stating this change would require results (i.e., confirmatory test but was not specified in Section 3.4 of modification of current immunoassay concentrations detected after using an the Guidelines. It was not the reagents, laboratory processes, or both. immunoassay with 60% cross-reactivity Department’s intent for the laboratory or The commenters noted that this imposes for hydromorphone). The Department IITF to calibrate an immunoassay test an unnecessary burden for compounds has evaluated the comments and has using an analyte other than that with such low incidence in workplace concluded that no change is needed for specified by the manufacturer. In the testing. The Department has evaluated immunoassay cross-reactivity preamble to the proposed UrMG, the the comments and has removed MDEA requirements. The requirements in Department described using a control from the Guidelines (i.e., MDEA is no Section 3.4 are necessary to ensure containing the lowest reacting analyte at longer included as an authorized drug consistency in testing among its cutoff concentration to establish the in Section 3.4). The number of positive laboratories using different decision point (i.e., when an MDEA specimens reported by HHS- immunoassay kits, as well as those immunoassay for grouped analytes did certified laboratories (i.e., information using different test methods for initial not demonstrate at least 80% cross- provided to the Department through the drug testing. Cross-reactivity must be reactivity to each analyte). The NLCP) does not support testing all demonstrated and documented by the Department has determined that this specimens for MDEA in federal manufacturer (e.g., package insert) and approach is not necessary, and will not workplace drug testing programs. by the HHS-certified laboratory or IITF be permitted. There are current Because MDEA is a Schedule I drug, a (i.e., assay validation studies, reagent lot immunoassays that meet the federal agency may test specimens for verification, and batch quality control requirements of this section for two or MDEA in accordance with Section 3.2 for any analyte that exhibits less than more analytes in a group (i.e., analytes (i.e., on a case-by-case basis for 100% cross-reactivity). The Department in the same drug class that have the reasonable suspicion or post accident will continue to allow the use of same initial test cutoff). As indicated in testing, routinely with a waiver from the methods other than immunoassay for Section 3.4, the laboratory or IITF may Secretary). The Department understands initial testing. use multiple test kits or a single kit to that MDA and some other analytes also However, the Department has revised meet the requirements. have a low incidence, but believes that Section 3.4 regarding the use of continued testing for these analytes is alternate technology initial tests for 3.5 May an HHS-certified laboratory warranted in a deterrent program. In THCA and benzoylecgonine. Depending perform additional drug and/or particular, inclusion of MDA as an on the technology, the confirmatory test specimen validity tests on a specimen at initial and confirmatory test analyte is cutoff (i.e., 15 ng/mL for THCA, 100 ng/ the request of the Medical Review warranted because, in addition to being mL for benzoylecgonine) must be used Officer (MRO)? a drug of abuse, it is a metabolite of as the cutoff for an initial test using an MDEA and MDMA. alternate technology to ensure One commenter recommended that An HHS-certified laboratory or consistent treatment of specimens. For HHS maintain a list of allowable Instrumented Initial Test Facility (IITF) these analytes, the immunoassay test is additional tests and reporting criteria may group analytes for initial testing. not specific for the target analyte for the (e.g., threshold for reporting as positive, For clarity, the Department has defined confirmatory test. For example, adulterated, substituted, and/or invalid, the term ‘‘grouped analytes’’ where used immunoassays for cannabinoids react and a limit of detection as appropriate), in footnote 1 of the table in Section 3.4: with multiple compounds that are to ensure consistency among ‘‘(i.e., two or more analytes that are in excreted as a result of marijuana use. laboratories and within the testing the same drug class and have the same Therefore, it is necessary to use an program. The Department has evaluated initial test cutoff).’’ immunoassay cutoff higher than that of the comment and has concluded that no The Department proposed criteria for the confirmatory test in order to detect change is needed. The Department does immunoassays for grouped analytes the target analyte (THCA) at or above not want to limit the analytes that may such as opioids and amphetamines, the confirmatory test cutoff. An initial be tested, and will provide guidance to specifying the minimum cross-reactivity test using an alternate technology with laboratories as needed. It is also noted to the other analyte(s) within the group. specificity comparable to the that the section requires all tests to meet Two commenters disagreed with the confirmatory test requires use of the appropriate validation and quality added cross-reactivity requirements, confirmatory test cutoff. control requirements. The procedures noting this section should not attempt to Also in Section 3.4, the Department and specimen records for such tests will provide equivalence between did not specify the target analyte to be be reviewed at NLCP inspections. The immunoassay and other initial testing used to calibrate an initial test for Department will continue to maintain a technologies. One of these commenters grouped analytes such as amphetamines list of HHS-certified laboratories that suggested the Department develop or opioids. Three commenters noted choose to perform additional tests for separate requirements for initial test that when an immunoassay is calibrated regulated specimens.

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One commenter asked whether an cutoff from 3.0 to 4.0 for identifying months. One commenter recommended MRO could submit a blanket request to specimens as adulterated. One that the Department define requirements perform additional testing (e.g., commenter advised caution in changing to be met before a new validity marker additional opioid metabolites) for all specimen validity test cutoffs, and is implemented. One commenter confirmatory specimens (i.e., would indicated that the proposed change will suggested that additional biomarkers laboratories be permitted to monitor the require updates to computer systems for used to support a result of invalid additional compounds in all reporting, calibrators, and controls. One should be standardized across all HHS- confirmatory test assays?). The commenter indicated that previous certified laboratories and one solution to Department believes that testing all review of data (more than 10 years ago) donor subversion might be random specimens for additional analytes may indicated this change would have more assignment of collection of alternative not be appropriate for some tests, than doubled the number of low pH/ specimens. The Department has especially hydrocodone, adulterated results reported. The evaluated the comments and has hydromorphone, oxycodone and commenter that disagreed with concluded that no change is needed. A oxymorphone. Recent studies show that changing the pH cutoff believes HHS 2006 study on the stability of regulated testing for norhydrocodone and or does not have enough scientific drug analytes in urine slightly below noroxycodone is not necessary for the evidence supporting the change. The and within the high pH invalid range interpretation of all results.12 Department has evaluated the comments supports the pH 9.0 decision point due Norhydrocodone and noroxycodone and has concluded that no change is to the loss of drug analytes at a pH metabolites may be helpful for the MRO needed to the proposed cutoff (i.e., 4.0). between 9.0 and 9.5.3 to interpret test results only when a As stated in the preamble to the donor’s prescription does not support proposed Guidelines (80 FR 28101), this Subpart D—Collectors the test results. For example, a decision is based on the fact that the 4.4 What are the requirements to be an hydrocodone dose may result in urine physiologically minimum achievable observer for a direct observed concentrations of only hydromorphone urine pH that can be produced by the collection? metabolite above the cutoff. The kidneys is about pH 4.5. Furthermore, presence of norhydrocodone metabolite the Department is not aware of any One commenter disagreed with the would support the use of hydrocodone medical conditions or medications that requirement for an observer to be the and validate the donor’s prescription. would cause urine pH to be less than same gender as the donor, and suggested The same could be said for interpreting 4.5. that a physician or health care test results following an oxycodone professional (regardless of gender) 3.8 What criteria are used to report a dose. The presence of noroxycodone should be allowed to function as an urine specimen as dilute? metabolite would support the use of observer. The commenter indicated that oxycodone when only oxymorphone One commenter suggested removing gender determination can be was reported as positive. The the three-decimal place criteria for challenging (i.e., transgender Department will provide guidance on reporting a specimen as dilute. One employees). The Department has these and other additional tests that may commenter indicated that the criteria for evaluated these comments and agrees provide useful information for the MRO reporting a specimen as dilute in that all observed collections must be in the Medical Review Officer Guidance Section 3.8 and 11.19(f) were not conducted in a professional manner that Manual for Federal Workplace Drug consistent, and that Section 3.8 does not minimizes discomfort to the donor. The Testing Programs. The Department has address the situation when creatinine is Department has revised Sections 4.4(b), revised Section 3.5 to clarify that HHS- between 5 and 20 mg/dL and the 8.1(b), and 8.10 to allow the donor to be certified laboratories are authorized to specific gravity is less than 1.0020. This observed by a person whose gender perform additional tests upon MRO section was intended to clarify that only matches the donor’s gender, which is request on a case-by-case basis, but are HHS-certified laboratories (and not determined by the donor’s gender not authorized to routinely perform HHS-certified IITFs) may report a identity (defined in Section 1.5). The such tests without prior authorization specimen as dilute when the creatinine donor’s gender identity may be the same from the Secretary or designated HHS concentration is greater than or equal to as or different from the donor’s sex representative, with the exception of the 2.0 mg/dL and less than or equal to 5 assigned at birth. The Department also determination of D,L stereoisomers of mg/dL, and the laboratory must use a revised Sections 8.1(b) and 8.12 for amphetamine and methamphetamine. four-decimal place refractometer for the monitored collections, to allow the The Department will continue to allow specific gravity test. The Department donor to be monitored by a person HHS-certified laboratories to test for D,L will retain the three-decimal place whose gender matches the donor’s amphetamine and methamphetamine criteria in Section 3.8(a) because both gender, unless the monitor is a medical routinely or upon MRO request. The HHS-certified IITFs and laboratories professional (as described in Section Department will provide guidance on may use a three-decimal place 8.12). these and other additional tests that may refractometer for a specific gravity The Department disagrees with the provide useful information for the MRO screening test when the creatinine commenter’s suggestion to allow an (e.g., tetrahydrocannabivarin) in the concentration is greater than 5 mg/dL individual to serve as an observer based Medical Review Officer Guidance and less than 20 mg/dL. However, the solely on their credentials as a Manual for Federal Workplace Drug Department agrees that this section did physician or health care professional. Testing Programs. not address all situations, so has revised Such credentials alone would not Additional drug and specimen the wording in Section 3.8(b) to be guarantee that these individuals could validity testing under Section 3.5 does consistent with the wording in 11.19(f). appropriately perform the functions of not include DNA testing. an observer (i.e., as specified in Section 3.9 What criteria are used to report an 4.4). 3.6 What criteria are used to report a invalid result for a urine specimen? The same commenter expressed urine specimen as adulterated? One commenter suggested increasing concerns over the requirement for an Two commenters agreed and one the acceptable pH range upper end from observer to have received training, disagreed with raising the lower pH 9.0 to 9.5 due to heat during summer indicating that this would require

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documentation and may make finding change is needed. Section 6.2 describes Department has revised Section 8.4 short notice observers more difficult. the information required in the MFR accordingly. The Department disagrees with this from the collector. However, the 8.5 What steps does the collector take comment. These are the same Department reworded items 6.2(b) and during and after the urine specimen requirements as in the Guidelines (c) for clarity. collection procedure? effective October 1, 2010 (73 FR 71858). Subpart H—Urine Specimen Collection As stated in the preamble to those 8.6 What procedure is used when the Procedure Guidelines, the training elements are donor states that they are unable to included to ensure that the observer 8.1 What privacy must the donor be provide a urine specimen? interacts with the donor in a given when providing a urine Comments on these two sections are professional manner, respecting the specimen? addressed here. Numerous commenters donor’s modesty and privacy, and that As described in this preamble under expressed concern with the the collector maintains the Section 4.4, the Department has revised Department’s urine collection policy, confidentiality and integrity of Section 8.1(b) to require that the gender stating that 7 to 10% of Americans have collection information. of the observer matches the donor’s a condition (‘‘paruresis’’), described as a Subpart F—Federal Drug Testing gender, and that the gender of the social anxiety disorder which prevents Custody and Control Form (CCF) monitor matches the donor’s gender a person from producing urine on unless the monitor is a medical demand or in the presence of other 6.1 What federal form is used to professional as described in Section people. These commenters stated that if document custody and control? 8.12. the government wants to seek the largest Two commenters recommended that group of qualified applicants, the 8.3 What are the preliminary steps in the Department provide instructions on Guidelines should specify that a the urine specimen collection recording results for the added drugs on diagnosis of paruresis means non-urine procedure? the CCF until the Federal CCF is (i.e., oral fluid) testing will revised. Three commenters One commenter was concerned that automatically be provided, and that recommended that the CCF be revised to the Guidelines do not mention alcohol donors should not have to attempt to address the addition of the oral fluid testing, which was added to the provide a urine specimen first. The specimen matrix. One commenter Department of Transportation (DOT) Department has evaluated the comments encouraged SAMHSA to modify the program in 1991. Alcohol testing is and has concluded that no change is CCF to account for collections where outside of the scope of the Department’s needed. The Guidelines will allow a multiple specimens are collected during regulatory authority granted by federal agency to use any authorized a single collection event. The Executive Order 12564 and Public Law specimen types (e.g., urine, oral fluid, or Department will publish a Federal 100–71. both) in their drug testing programs. The Register Notice with the revised Federal In response to comments described Guidelines will continue to require that CCF, including changes for the added under Sections 1.7 and 8.4 in this the donor be allowed reasonable analytes, with the same effective date as preamble, the Department revised attempts to provide a urine specimen as these Guidelines. Guidance on the use Section 8.3(h) to require the collector to described in Sections 8.5 and 8.6, and of the revised Federal CCF will be report a refusal to test when a donor allow collection of an authorized posted on the SAMHSA Web site http:// brings materials for adulterating, alternate specimen (i.e., oral fluid). www.samhsa.gov/workplace. In regard substituting, or diluting a specimen to Three commenters disagreed with the to when the collector submits multiple the collection site. requirement for the collector to contact the agency representative for urine specimens (i.e., different voids) 8.4 What steps does the collector take collected during the same testing event, authorization to collect an alternate in the collection procedure before the specimen each time a donor is unable to the Department has concluded that no donor provides a urine specimen? change is needed; the collector must use provide a sufficient volume. These a separate Federal CCF for each The proposed section included the commenters suggested that the specimen. same requirement as the Guidelines Guidelines allow this to be addressed in effective October 1, 2010 (73 FR 71858) established standard protocols for the 6.2 What happens if the correct OMB for the collector to perform an observed agency. The Department agrees with the approved Federal CCF is not available collection when the donor exhibits commenters. Each federal agency may or is not used? conduct that clearly indicates an decide whether to require notification in One commenter questioned the attempt to tamper with a specimen (e.g., each case or whether to provide a purpose of a Memorandum for the substitute urine in plain view or an standard protocol for collectors to Record (MFR) obtained from the attempt to bring into the collection site follow. Sections 8.5 and 8.6 have been collector when an incorrect CCF was an adulterant or urine substitute). One revised accordingly. used for the collection. The commenter commenter stated that if the collector Also in regard to Section 8.6, one suggested that if certain information is finds an adulterant or substitution commenter indicated that some required to be in the MFR, these product or observes the donor attempt employers may wish to retain urine requirements should be specified in the to substitute a urine specimen, this testing as the primary test due to a Guidelines. The commenter suggested should be a refusal to test. As noted longer detection window. This that if the purpose of the MFR is to under Section 1.7 in this preamble, the commenter raised concern that some correct the collector’s behavior (i.e., Department agrees that the collector donors may claim they are unable to using an incorrect form), then it would must report a refusal to test when a provide a urine specimen so that an be more effective to reject the specimen donor brings materials for adulterating, alternative specimen (i.e., OF) with a upon receipt and indicate that it was substituting, or diluting a specimen to shorter detection window will be rejected due to the use of an incorrect the collection site, or when the collector collected. The commenter suggested form. The Department has evaluated the observes a donor’s clear attempt to that the Guidelines be changed to comments and has concluded that no tamper with a specimen. The indicate that an alternative specimen

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may be collected when a donor is the collector to distribute copies of the records the name and gender of the physiologically unable to provide a Federal CCF as required. monitor on the Federal CCF. A medical urine specimen, and not just when the professional may serve as the monitor, 8.9 When is a direct observed donor states that they are unable to regardless of gender. collection conducted? provide a urine specimen. The The proposed section included Subpart I—HHS Certification of Department disagrees; collectors are not Laboratories and IITFs qualified to conduct a medical requirements for the collector to evaluation to verify or refute the donor’s perform an observed collection when 9.5 What are the qualitative and claim. It will be the agency’s decision to the donor exhibits conduct that clearly quantitative specifications of collect urine or an authorized alternate indicates an attempt to tamper with a performance testing (PT) samples? specimen or the collector observed specimen, and Sections 13.6 and 13.7 One commenter noted that, because materials brought by the donor to the include procedures for medical proposed initial test requirements allow collection site for the purpose of evaluation as needed during the MRO calibration with a low-reacting analyte, adulterating, substituting, or diluting review process. PT schemes would likely need to be the specimen. One commenter stated The Department reworded Section designed based on the specific that if the collector finds an adulterant 8.5(d) to clarify that the collector must implementation at each laboratory. The or substitution product or observes the record comments on both CCFs when commenter provided an example: When donor attempt to substitute a urine two specimens from the same collection an immunoassay is calibrated with a specimen, this should be a refusal to event are forwarded to a laboratory. drug/metabolite that exhibits 50% cross- test. As noted in this preamble under reactivity, the intended target analyte 8.7 If the donor is unable to provide a Sections 1.7 and 8.4, the Department (‘‘calibrant’’) at the cutoff concentration urine specimen, may another specimen agrees that the collector must report a would elicit a response well in excess type be collected for testing? refusal to test when a donor brings of the cutoff. This could result in materials for adulterating, substituting, inaccurate initial test results (i.e., a The Department proposed within or diluting the specimen to the positive initial test result for a specimen Section 8.7 that when the donor is collection site, or when the collector containing the calibrant at a unable to provide a urine specimen, observes a donor’s clear attempt to concentration below the cutoff). The another specimen type may be collected tamper with a specimen. The only if specifically authorized by the commenter stated that this result could Department has revised Section 8.9 be scored as a ‘‘false positive’’ PT result. agency. One commenter disagreed with accordingly. the Guidelines as written and suggested The Department has evaluated the that when a donor cannot provide the 8.10 How is a direct observed comment and has concluded that no primary specimen type, an alternate collection conducted? change is needed. As noted above specimen should be collected To address a comment described in regarding Section 3.4, it was not the immediately. The commenter cited the this preamble under Section 4.4, the Department’s intent for the laboratory or additional time and cost (evaluation of Department has revised Section 8.10 to IITF to calibrate an immunoassay test donor for ‘‘shy bladder’’) as well as the allow the donor to be observed by an using an analyte other than that fact that the collector may not know the observer whose gender matches the specified by the manufacturer. NLCP PT agency’s policy on alternate specimen donor’s gender. At the beginning of the schemes are designed based on known types. The Department has concluded observed collection, the collector cross-reactivity profiles of the initial that no change is needed for Section 8.7 requests that the donor document the tests used by HHS-certified laboratories. Also in regard to proposed Section in response to this comment. The donor’s gender on the Federal CCF and 9.5, one commenter suggested that the Guidelines will continue to require that initial the annotation. An observer of Guidelines use the same wording as in the donor be allowed reasonable the same gender is provided, and the the Guidelines effective October 1, 2010 attempts to provide a urine specimen as collector records the name and gender (73 FR 71858) for retest PT sample described in Sections 8.5 and 8.6. The of the observer on the Federal CCF. Department has revised those sections specifications (i.e., ‘‘. . . may be as low to allow a federal agency to either 8.12 How is a monitored collection as . . .’’ rather than the proposed require notification in each case or conducted? wording ‘‘. . . may be less than. . .’’). provide a standard protocol for To address a comment described in The Department agrees and has collectors to follow when the donor is this preamble under Section 4.4, the reinstituted wording from Section 9.3 of unable to provide a urine specimen. The Department has revised Section 8.12 to the Guidelines effective October 1, 2010 Department has reworded this section to allow the donor to be monitored by a (73 FR 71858) into Section 9.5(a)(1)(ii). state ‘‘Yes, if . . .’’ rather than ‘‘No, monitor whose gender matches the Subpart J—Blind Samples Submitted by unless . . . .’’ in response to a federal donor’s gender, unless the monitor is a an Agency agency’s comment and to enhance medical professional (e.g., nurse, doctor, clarity. The meaning of this section physician’s assistant, technologist, or 10.1 What are the requirements for remains the same. technician licensed or certified to federal agencies to submit blind samples practice in the jurisdiction in which the to HHS-certified laboratories or IITFs? 8.8 How does the collector prepare the collection takes place). As described in Two commenters disagreed with the urine specimens? Section 8.10, at the beginning of the proposed limit to the number of blind In response to a federal agency monitored collection, the collector samples required (i.e., a maximum of comment, the Department deleted a follows the same procedure as for 400 blind samples per year) in Section sentence in item 8.8(h) that required the observer selection in Section 8.10(b). 10.1(b). The commenters indicated that collector to send a copy of the Federal That is, the collector requests that the for a large agency, there is a very large CCF to the HHS-certified laboratory or donor document the donor’s gender on difference between 3% and 400 samples IITF. The Department agreed with the the Federal CCF and initial the and suggested keeping only the 3% federal agency that this instruction is annotation. A monitor of the same requirement. Another commenter redundant because item 8.8(g) instructs gender is provided, and the collector disagreed with the 3% requirement for

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blind samples and requested that the alternate technology. Furthermore, less than 100% cross-reactivity with the amount to be lowered to 1% to lessen Section 1.5 includes the definition for assay, to demonstrate that the the burden on employers. One ‘‘alternate technology initial drug test.’’ requirement for at least 80% cross- commenter suggested that the wording reactivity has been met. 11.11 What must an HHS-certified be modified to clarify that employers are laboratory do to validate an initial drug 11.12 What are the batch quality responsible for ensuring blind samples test? control requirements when conducting are sent to the laboratories, but that an initial drug test? collectors are tasked with submitting the One commenter noted that an blind samples. The Department has immunoassay initial test calibrated with 11.15 What are the batch quality evaluated the comments and has a low-reacting analyte may not be able control requirements when conducting a concluded that no change is needed. to meet Guidelines requirements for confirmatory drug test? The 400 sample limit was added to performance of the test around the Comments on these two sections are reduce the burden on large agencies cutoff concentration. The Department addressed here. One commenter based on the Department’s review of has evaluated the comments and has requested clarification for the agencies’ blind testing programs. The concluded that no change is needed. All requirement for a drug-free control in wording in Section 10.1(a) clearly tests must be validated by the HHS- initial and confirmatory drug test describes the responsibilities of the certified laboratory to meet the batches (i.e., whether the control should federal agency and the role of the requirements prior to use for regulated contain no drug or whether the control collector in blind sample submission; drug testing. should not contain the specific analyte One commenter noted that the however, the Department reworded for that test). The Department has requirement in section 11.11(b) for Section 10.3(a) for clarity as described evaluated the comment and has reagent verification prior to use is an below. concluded that no change is needed. operational, not a validation, These Guidelines sections list the 10.3 How is a blind sample submitted requirement. The Departments agrees requirement for ‘‘at least one control to an HHS-certified laboratory? with the commenter but has concluded certified to contain no drug or drug that no change is needed. While this The Department has reworded Section metabolite,’’ meaning that the control section addresses initial drug test 10.3(a) to clarify that the collector sends must contain no regulated drug validation requirements, the verification a blind sample to a laboratory or IITF as analytes. a split specimen (i.e., Bottle A and of each new reagent lot is essential to Bottle B). verify that lot-to-lot differences have not 11.16 What are the analytical and significantly affected assay performance quality control requirements for Subpart K—Laboratory as demonstrated and documented conducting specimen validity tests? 11.10 What are the requirements for an during validation. Therefore, this is the One commenter found the wording of initial drug test? most appropriate section of the Section 11.16(a) to be confusing, noting Guidelines to include the requirement. that a specimen would not be subjected One commenter noted that HHS to a second specimen validity test when previously required initial and 11.12 What are the batch quality the first test was in the acceptable range. confirmatory testing using different control requirements when conducting an initial drug test? The Department agrees with the techniques, and asked whether this comment and has revised Section requirement had been removed with One commenter noted that this and 11.16(a) to correctly reflect allowance of technologies other than other sections use inconsistent requirements. immunoassay for initial testing. The terminology when describing quality commenter expressed concern that an controls samples relative to the cutoff 11.18 What are the requirements for error in the initial drug test could be concentration (i.e., ‘‘25 percent above conducting each specimen validity test? repeated in the confirmatory drug test the cutoff,’’ ‘‘75 percent of the cutoff’’). One commenter noted that the using the same method. The Department The commenter suggested that the proposed changes in the lower pH cutoff has evaluated the comments and has Department use one version for identifying adulterated specimens concluded that no change is needed. consistently. The Department has and lower pH decision point for The Guidelines maintain the considered the comment and has identifying invalid specimens may requirement for initial and confirmatory concluded that no change is needed. cause additional costs for manufacturers tests on two separate aliquots to report These terms have been used in the and laboratories. The Department has a result other than negative. The NLCP Guidelines, in NLCP documents, and in evaluated the comment and has will review validation and quality other guidance to HHS-certified concluded that no change is needed. control records, as well as specimen laboratories without issue. The Department recognizes that the records, to ensure that the initial and One commenter asked whether the revised cutoff will necessitate changes confirmatory testing methods meet added analytes affect quality control by HHS-certified laboratories as well as Guidelines requirements and provide content requirements. The Department by manufacturers of commercial quality scientifically and forensically has evaluated the comment and has control samples; however, the 4.0 pH supportable results. concluded that no change is needed. cutoff is supported by scientific studies Also in regard to the proposed Section The initial drug test quality control and workplace drug testing data, and is 11.10, one commenter asked whether requirements in the Guidelines apply to expected to reduce the incidence of non-FDA cleared immunoassays were each analyte used to calibrate the test undetected attempts to subvert the drug included in the category of alternate (i.e., immunoassay or alternate test. initial drug test technology. The technology initial drug test). When a Department has evaluated the comment single immunoassay test is used for two 11.19 What are the requirements for an and has concluded that no change is or more analytes in a drug class, the HHS-certified laboratory to report a test needed. This section clearly HHS-certified laboratory or IITF must result? distinguishes initial tests using include a control in accordance with One commenter suggested that the immunoassay from those using an item 11.12(a)(2) for each analyte that has Department remove the requirement for

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an executed CCF as the official report change in the MRO’s role represents an that the MRO meets the Guidelines for ‘‘non-negative’’ specimens and unjustified shifting of risk to the MRO. qualification requirements. permit the use of an electronic report One commenter believes the term Two commenters disagreed with the with the required information. The presents a possible legal flaw to the requirement for MRO recertification Department has evaluated the comment Guidelines, stating that this term is every five years, and recommended that and has concluded that no change is legally different from ‘‘safety concern’’ MROs complete training every three needed. The Federal CCF serves as the and places MROs in the position of years. Five commenters stated support chain of custody for the specimen from being in conflict with the prescribing for five year requalification and the time of collection until receipt by physician and subject to lawsuits. This examination requirements. The the laboratory and also contains the commenter stated that even a lack of a Department has evaluated the comments certification statement signed by the finding of nonmedical use could be an and has concluded that no change is certifying scientist. The Federal CCF issue if the donor subsequently had an needed. The Department will keep the may be paper or electronic. accident after using the drug. The same five-year recertification requirement as commenter submitted five proposed. 11.21 How long must an HHS-certified recommendations related to inclusion of laboratory retain records? 13.2 How are nationally recognized prescription drugs in federal workplace entities or subspecialty boards that In Section 11.21, the Department drug testing programs, to address the certify MROs approved? proposed that laboratories be allowed to commenter’s concerns with the convert hardcopy records to electronic proposed Guidelines. These five specific One commenter agreed with MRO records for storage and then discard the recommendations pertain to matters that certification/training entities submitting hardcopy records after six months. One are outside the scope of these the delivery method and content of the MRO examination as applicable along commenter stated their assumption that Guidelines, and therefore are not with other required documents. One this section did not require laboratories addressed in the Department’s response commenter agreed with extending time to convert electronic records to below. hardcopy records and maintain them for from one to two years for approved The responsibilities of an MRO to MRO certification/training entities’ six months. This assumption is correct; interpret results have largely remained the intent is to allow laboratories to resubmission of qualifications for HHS the same between the Guidelines approval. The commenter noted that maintain records in electronic format for effective October 1, 2010 (73 FR 71858) the required storage period. The they would support further extension to and these Guidelines. As stated in 3 years. One commenter recommended Department has concluded that no Section 13.5(c) of these Guidelines, ‘‘if change is needed. that approval of MRO educational the donor provides a legitimate medical courses and content be at the discretion 11.22 What statistical summary reports explanation (e.g., a valid prescription) of the MRO certification entities, not must an HHS-certified laboratory for the positive result, the MRO reports HHS. Since the certification entities and provide for urine testing? the test result as negative to the their examinations are subject to HHS agency.’’ Accordingly, the intent of the oversight and approval, the commenter One commenter asked why the Guidelines, in this context, is to confirm proposed Guidelines include a noted that it may be burdensome for whether a positive drug test is the result HHS to review and approve the courses requirement for a copy of the of drug use under a valid prescription. semiannual statistical summary report and content, and be a disincentive to Furthermore, the term ‘‘alternate development of new courses. One to be sent to the Secretary or designated medical explanation’’ has never been HHS representative. The Department commenter recommended that used in the Guidelines, but has been examinations be allowed to be in-person included the requirement in Section used in the HHS Medical Review Officer or online with appropriate security 11.22 (and in Section 12.19 for IITFs) to Manual for Federal Workplace Drug precautions for each delivery method. facilitate compilation of statistical Testing Programs. The Department has evaluated the information for the federal drug-free For the reasons above, the Department comments and agrees that the workplace program. This will not place believes that the definition of submission of training materials to HHS an additional burden on the test ‘‘nonmedical use of a drug’’ and the would possibly discourage the facilities other than transmission of the requirement for a physician serving as development of new training courses. report. The Department will continue to an MRO to have knowledge of this topic Therefore, the review of MRO evaluate the effectiveness of this do not fundamentally change the MRO’s educational courses and content will requirement. responsibilities. However, to address the not be part of the approval process for Subpart M—Medical Review Officer commenters’ concerns, the Department MRO certification entities. As described (MRO) has removed this term from the under Medical Review Officer (MRO) Guidelines (i.e., revised Sections 1.5 requalification—continuing education 13.1 Who may serve as an MRO? and 13.1). units (CEUs) in this preamble, the Three commenters disagreed with the The Department proposed within Department has removed references to term ‘‘nonmedical use of a drug’’ used Section 13.1 who may serve as an MRO. MRO training entities in Section 13.2, in Section 13.1 (and defined in Section One commenter requested clarification because training documentation is 1.5) and indicated that the term changes that it is the federal agency’s burden to maintained by MRO certification the role of an MRO from review, verify ensure that the MRO is certified. One entities. The Department will only and ‘‘report a non-negative result’’ to commenter asked how the laboratory require the MRO certification entities to review, verify and ‘‘interpret before will be informed that an MRO has met submit their examination and any other reporting a result as negative or requirements for re-qualification. The necessary supporting examination nonmedical use of a drug.’’ Two Department evaluated the comments materials (e.g., answers, examination commenters disagreed with use of and concluded that no change is statistics or background information on ‘‘interpretation of results’’ to supplant needed. The MRO is an employee or a questions) that will help in the ‘‘alternative medical explanation.’’ One contractor of the agency. Therefore, it is Department’s evaluation of the commenter noted that this perceived the agency’s responsibility to ensure examination. The Department will

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review and evaluate the examination entities, and added item 13.3(b) to The Department also revised Section delivery method (e.g., in-person or require MRO training on revised 13.5(d) to reflect the policy of the online) when reviewing submitted Guidelines prior to their effective date. Department that passive exposure to training materials to ensure that the marijuana smoke and ingestion of food 13.4 What are the responsibilities of an delivery method employs appropriate products containing marijuana are not MRO? security and identification procedures. acceptable medical explanations for a One commenter suggested creating a positive drug test result. Individuals 13.3 What training is required before a subset of medical professionals trained physician may serve as an MRO? who are passively exposed to marijuana specifically to determine fitness for duty smoke or who consume food products Five commenters disagreed and one since an MRO cannot determine fitness containing marijuana can pose public commenter agreed with the added for duty over the telephone. The safety and/or security risks.45 Marijuana requirement for MRO training to include Department has evaluated the comment is listed as a Schedule I drug under the information about how to discuss and has concluded that no change is Controlled Substances Act. substance misuse and abuse and how to needed. Fitness for duty evaluations fall access those services. The Department outside the purview of the Guidelines. 13.6 What action does the MRO take has evaluated the comments and has when the collector reports that the 13.5 What must an MRO do when revised Section 13.3 to remove this donor did not provide a sufficient reviewing a urine specimen’s test requirement. Federal agencies may amount of urine for a drug test? results? provide this information to employees One commenter suggested the and applicants to facilitate their access The Department has revised Section Guidelines define ‘‘appropriate to effective treatment and support 13.5(d)(1) to include an example of expertise’’ of a physician with a list of recovery. The Department provides documentation to support a medical conditions and an appropriate type of information to the public on help and explanation for a positive drug test physician in an appendix. The same treatment for substance misuse and result. commenter requested medical referral Three commenters disagreed with abuse, and how to access those services, information on the employer’s actions MRO procedures for ‘‘a positive result on the SAMHSA Web site http:// when a donor could not provide a urine for opiates’’ (i.e., requirement for www.samhsa.gov/. specimen and then could not provide an clinical evidence of illegal use in One commenter stated that the oral fluid specimen. The Department Department should add a requirement addition to positive result) and noted that the proposed Guidelines wording has evaluated the comments and has for MRO training on what constitutes a concluded that no change is needed. A refusal to test. One commenter was not changed to clarify that the described procedures do not apply to physician who is a trained MRO will suggested that the Department should have the knowledge necessary to add a requirement for MRO training on the added opioids. The Department agrees with the commenters and has identify another physician with when and how to report safety concerns appropriate expertise for the medical to employers when prescription and/or revised Section 13.5(d) to clarify that the procedures do not apply to the evaluation. The Department will over-the-counter medications may affect provide additional guidance in the HHS performance. The Department has added opioid analytes. Wording in Medical Review Officer Guidance evaluated the comments and has Section 13.5(d)(2)(i) regarding ‘‘clinical Manual for Federal Workplace Drug concluded that no change is needed. evidence of illegal use’’ was also edited Testing Programs as appropriate when Criteria for reporting a refusal to test are for clarity and for consistency with the alternate specimen types (e.g., oral covered under the topics listed in wording in the OFMG. fluid) are allowed in federal workplace Section 13.3 such as items (a)(4) training One commenter disagreed with drug testing programs. on the Guidelines and (a)(5) procedures requirements concerning two separate The Department clarified the for interpretation, review, and reporting specimens collected at a single test definition of ‘‘permanent or long-term of results. When a donor provides a event and sent to the laboratory for medical conditions’’ in Section legitimate medical explanation for a testing (e.g., a urine specimen outside 13.6(b)(1) based on a federal agency positive drug test result (e.g., a valid the acceptable temperature range and comment. prescription), the Guidelines do not the subsequently collected specimen). require MROs to contact federal agency The proposed Guidelines require that, Subpart O—Criteria for Rejecting a employers for the purpose of reporting when one of the two specimens is Specimen for Testing a safety concern. Accordingly, MRO negative and other is not, the MRO 15.1 What discrepancies require an training related to reporting ‘‘safety reports only the verified result other HHS-certified laboratory or an HHS- concerns’’ does not relate to a than negative. This commenter certified IITF to report a specimen as mandatory function under the suggested that the MRO cancel the rejected for testing? Guidelines and, therefore, is not an negative result. The Department has essential component of required MRO evaluated the comments and has The Department revised wording in training. The Department will provide concluded no change is needed. items a and b of this section, and additional guidance in the HHS Medical Cancellation of the test may be included three additional fatal flaws as Review Officer Guidance Manual for confusing in the situation referenced by items f–h, to reflect fatal flaws for Federal Workplace Drug Testing the commenter and lead to regulated donor specimens that have Programs. inappropriate specimen recollection. been identified by HHS-certified In addition, the Department revised Both the MRO and the federal agency laboratories. These fatal flaws were Section 13.3 as described under Medical employer will receive their Federal CCF addressed in NLCP guidance sent to all Review Officer (MRO) requalification— copies with explanatory collector HHS-certified and applicant laboratories continuing education units (CEUs) in remarks in Step 2 including the and IITFs on August 9, 2016. In this preamble. The Department removed specimen identification number of the addition, the Department revised this references to MRO training entities, associated specimen, and the MRO may section to include an additional item i because training documentation is provide additional comment in the to allow a laboratory or IITF to reject a maintained by MRO certification MRO’s report. specimen when they identify a flaw that

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prevents testing or affects the forensic employers no longer use social security additional regulatory requirements and defensibility of the drug test, and cannot numbers for employee identification. allow an activity that was otherwise be corrected. This general item enables The Department agrees and has revised prohibited. The Administrative laboratories and IITFs to reject Section 15.3(a)(5) to include ‘‘employee Procedure Act (APA) delineates an specimens with fatal flaws that may be identification number’’ in addition to exception to its rulemaking procedures rare, but do occur. It is not possible to ‘‘Social Security Number.’’. for ‘‘a matter relating to agency list all such flaws in the Guidelines. management or personnel’’ 5 U.S.C. 15.4 What discrepancies may require 553(a)(2). Because the Guidelines issued 15.3 What discrepancies are not an MRO to cancel a test? by the Secretary govern federal sufficient to require an HHS-certified One commenter suggested adding the workplace drug testing programs, HHS laboratory or an HHS-certified IITF to scenario where the donor did not sign has taken the position that the reject a urine specimen for testing or an the CCF because the collector forgot to Guidelines are a ‘‘matter relating to MRO to cancel a test? ask the donor to sign, rather than the agency management or personnel’’ and, Two commenters indicated that donor’s refusal to sign. The Department thus, are not subject to the APA’s inclusion of some items as insignificant has evaluated the comment and has requirements for notice and comment discrepancies contradicts guidance concluded that no change is needed. As rulemaking. This position is consistent provided to HHS-certified laboratories stated in Section 15.4, the MRO contacts with Executive Order 12564 regarding and IITFs in NLCP Notices, which the collector ‘‘to obtain a statement to Drug-Free Workplaces, which directs required laboratories to attempt to verify that the donor refused to sign the the Secretary to promulgate scientific recover missing information. One of MRO copy.’’ and technical guidelines for executive these commenters suggested that if these agency drug testing programs. However, items are important, they should be Regulatory Impact and Notices the statute under which the mandatory removed from the ‘‘insignificant’’ list. Executive Orders 13563 and 12866 guidelines were created (Pub. L. 100–71, Two commenters disagreed with the section 503(a)(3)) required notice and Executive Order 13563 of January 18, Guidelines designating the listed comment apart from the APA. This 2011 (Improving Regulation and omissions and discrepancies as provision provides the following: ‘‘insignificant only when they occur no Regulatory Review) states ‘‘Our regulatory system must protect public (3) Notwithstanding any provision of more than once per month.’’ The chapter 5 of title 5, United States Code, the Department has evaluated the health, welfare, safety, and our environment while promoting economic mandatory guidelines to be published comments. The listed discrepancies pursuant to subsection (a)(l)(A)(ii) shall be would not result in rejection or growth, innovation, competitiveness, published and made effective exclusively cancellation. NLCP Notices requiring and job creation.’’ Consistent with this according to the provisions of this paragraph. laboratory action are consistent with mandate, Executive Order 13563 Notice of the mandatory guidelines proposed this section. However, the Department requires agencies to tailor ‘‘regulations by the Secretary of Health and Human has reworded section 15.3 to not classify to impose the least burden on society, Services shall be published in the Federal Register, and interested persons shall be these errors as insignificant. While these consistent with obtaining regulatory objectives.’’ Executive Order 13563 also given not less than 60 days to submit written types of errors do not warrant laboratory comments on the proposed mandatory rejection of a specimen or MRO requires agencies to ‘‘identify and guidelines. Following review and cancellation of a test, as noted in section consider regulatory approaches that consideration of written comments, final 15.3(c), corrective action must be reduce burdens and maintain flexibility mandatory guidelines shall be published in initiated when they occur more than and freedom of choice’’ while selecting the Federal Register and shall become once a month. ‘‘those approaches that maximize net effective upon publication. The commenters indicated that this benefits.’’ This notice presents a The Department included a section implies that the MRO must keep regulatory approach that will reduce Regulatory Impact and Notices section a log of insignificant errors by laboratory burdens to providers and to consumers with cost and benefits analysis and and by collection site in order to track while continuing to provide adequate burden estimates in the May 15, 2015 frequency. The commenters noted that protections for public health and Federal Register Notice for the this is an unenforceable policy, that this welfare. proposed UrMG (80 FR 28101), and should be a duty of inspectors of The Secretary has examined the requested public comment on all figures laboratories and collection sites, and impact of the Guidelines under and assumptions. The Department’s that requiring MROs to keep these types Executive Order 12866, which directs projections were developed using of logs would create significant extra federal agencies to assess all costs and information from current HHS-certified costs. One commenter suggested that benefits of available regulatory urine testing laboratories, with input item 15.3(c) be modified for the MRO to alternatives and, when regulation is from DOT and the Nuclear Regulatory advise the collector or laboratory to necessary, to select regulatory Commission (NRC), and cost analysis retrain staff on relevant procedures to approaches that maximize net benefits was based on information provided by ensure that collections are completed (including potential economic, multiple HHS-certified laboratories and correctly (rather than directing them to environmental, public health and safety, MROs. The Department received no immediately take corrective action). The and other advantages; distributive substantive data or evidence through Department has evaluated the comments impacts; and equity). public comments in favor of changing and has concluded that no change is According to Executive Order 12866, the estimated costs and benefits needed. This section is the same as in a regulatory action is ‘‘significant’’ if it provided in the Department’s May 2015 the Guidelines effective October 1, 2010 meets any one of a number of specified Federal Register Notice for the UrMG, (73 FR 71858). conditions, including having an annual and therefore, has retained the analysis One commenter suggested modifying effect on the economy of $100 million; and estimates provided in that notice 15.3(a)(5) to read ‘‘donor identification adversely affecting in a material way a below. Comments that related to the number’’ which would include a social sector of the economy, competition, or costs and benefits of this rule are security number or an employee jobs; or if it raises novel legal or policy summarized and discussed above in the identification number since many issues. The Guidelines do establish Summary of Public Comments and

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HHS’s Response under the heading within the group. These Guidelines $0.10 per submitted specimen. This Costs and Benefits. allow the use of methods other than would indicate that the cost per immunoassay for initial testing. An specimen submitted for testing will Need for Revisions to the Guidelines immunoassay manufacturer may incur increase by $0.11–$0.30. Annual The inclusion of oxycodone, costs if they choose to alter their recurring testing costs in the table below oxymorphone, hydrocodone and existing product and resubmit the are based on an estimated number of hydromorphone in the URMG was immunoassay for FDA clearance. 6,145,500 specimens. recommended by the DTAB, reviewed For the added opiate analytes, the two by the Department’s Prescription Drug immunoassays currently used for The addition of the Schedule II Subcommittee of the Behavioral Health oxycodone and oxymorphone meet the prescription medications will require Coordinating Committee, and approved requirements, and two of the three MRO review to verify legitimate drug by the SAMHSA Administrator in existing opiate immunoassays used in use. Based on the positivity rates from January 2012. This action is supported certified laboratories meet the non-regulated workplace drug testing by various data, described in this requirements for hydrocodone and for these analytes and the additional preamble.1–4 In addition, in 2008, 12 hydromorphone analysis. The opiate review of specimens confirmed positive percent of military personnel admitted immunoassay that does not have for prescription medications, MRO costs to the illicit use of prescription sufficient cross-reactivity would be are estimated to increase by medications. Prevalence testing by the acceptable as an initial test under these approximately 3%. The burden of this Department of Defense (DoD) in 2009 Guidelines when the lowest-reacting 3% cost increase is expected to shift indicated that prescription drug abuse analyte, hydromorphone, is used to gradually from MROs to agencies as exceeded illegal drug abuse. Because of establish a decision point. Therefore, agencies’ existing contracts expire and this, hydrocodone and hydromorphone the Department assumes that all they renegotiate the terms of new testing was added to the regular DoD certified laboratories will elect to use contracts, with an increase to the total drug testing panel in 2011. existing immunoassays. Thus, the costs cost of a federal drug test over time to between $0.60–$1.35. This cost would Costs associated with implementing the initial tests for these analytes is expected to be indicate a total cost of $3,687,300 to Costs associated with the de minimis. $8,296,425 in the urine testing program. implementation of testing for For amphetamines, one of the three A federal agency may also incur oxycodone, oxymorphone, hydrocodone existing additional costs (e.g., additional and hydromorphone will be minimal methylenedioxymethamphetamine managerial effort to arrange substitute because the Department has determined (MDMA) immunoassays used in workers) when an employee tests that all HHS certified laboratories certified laboratories meets the positive for a prescription medication testing specimens from federal agencies requirements. The remaining two and is removed from duties during the are currently conducting tests for one or exhibit insufficient cross-reactivity for MRO verification process. more of these analytes on non-regulated MDA. These two immunoassays would The additional costs for testing and urine specimens. Likewise, there will be be acceptable as an initial test under MRO review will be incorporated into minimal costs associated with changing these Guidelines when the lowest- the overall cost for the federal agency initial testing to include MDA since the reacting analyte, MDA, is used to submitting the specimen to the current immunoassays can be adapted establish a decision point. An to test for this analyte. Laboratory immunoassay manufacturer may incur laboratory. The estimation of costs personnel are currently trained and test costs if they choose to alter their incurred is based upon overall cost to methods have been implemented. existing product and resubmit the the federal agency because the review of However, there will be some immunoassay for FDA clearance. Again, positive specimens is usually based on administrative costs associated with the Department assumes that certified all specimens submitted from an adding these analytes. Prior to being laboratories will use the existing agency, rather than individual specimen allowed to test regulated specimens for immunoassays and incur de minimis testing costs or MRO review of positive these compounds, HHS certified costs. specimens. Agencies may also incur laboratories will be required to Once the testing has been some costs for training of federal demonstrate that their performance implemented, the cost per specimen for employees such as drug program meets Guideline requirements by testing initial testing for the added analytes will coordinators due to implementation of three (3) groups of PT samples. The range from $.06 to $0.20 due to reagent the revised Guidelines. Based on current Department will provide the PT samples costs. Current costs for each training modules offered to drug through the National Laboratory confirmatory test range from $5.00 to program coordinators, and other Certification Program (NLCP) at no cost $10.00 for each specimen reported associated costs including travel for to the certified laboratories. Based on positive, due to sample preparation and 90% of drug program coordinators, the costs charged for specimen testing, analysis costs. Based on information estimated total training cost for a one- laboratory costs to conduct the PT from non-regulated workplace drug day training session would be between testing would range from $900 to $1,800 testing for these analytes and testing $108,000 and $138,000 (i.e., assuming 8 for each certified laboratory. performed by the Department on de- hours of time multiplied by a GS 12/13 In Section 3.4, the Department identified federally regulated specimens wage including benefits and overhead included criteria for calibrating initial in 2011, approximately 1% of the adjustments). The Department will offer tests for grouped analytes such as submitted specimens is expected to be the choice of online or in-person opiates and amphetamines, and confirmed as positive for the added training. This will eliminate travel costs specified the cross-reactivity of the analytes. Therefore, the added cost for for those federal agencies who choose to immunoassay to the other analytes(s) confirmatory testing will be $0.05 to use online training.

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RECURRING ANNUAL COSTS SUMMARY TABLE

Lower bound Upper bound

Reagent Costs ...... $368,730.00 $1,229,100.00 Additional Confirmatory tests ...... 307,275.00 614,550.00 MRO Costs ...... 3,687,300.00 8,296,425.00

Total annual costs ...... 4,363,305.00 10,140,075.00

UPFRONT (ONE-TIME) COSTS SUMMARY TABLE

Lower bound Upper bound

Performance Testing ...... $27,900.00 $55,800.00 Training ...... 108,000 138,000

Total ...... 135,900.00 193,800.00

Benefits of $100 million; a major increase in legislative comments or proposed The potential benefits of deterring use costs or prices; significant effects on legislation, and other policy statements of oxycodone, oxymorphone, competition, employment, productivity, or actions that have substantial direct hydrocodone and hydromorphone are or innovation; or significant effects on effects on the states, on the relationship the prevention of their side effects (e.g., the ability of U.S.-based enterprises to between the national government and anxiety, dizziness, drowsiness, fatigue, compete with foreign-based enterprises the states, or on the distribution of and other neurological effects), which in domestic or export markets. This is power and responsibilities among the will result in a healthier and more alert not a major rule under the Small various levels of government. workforce as well as avoid the issues Business Regulatory Enforcement In this notice, the Secretary revised associated with addiction and Fairness Act (SBREFA) of 1996. the standards for certification of laboratories engaged in urine fluid drug rehabilitation. Since the personnel Unfunded Mandates tested under this program are in testing for federal agencies and the use positions that are safety sensitive, The Secretary has examined the of urine testing in federal drug-free potential benefits include decreased risk impact of the Guidelines under the workplace programs. The Department of of transportation accidents, decreased Unfunded Mandates Reform Act Health and Human Services, by risk of low-probability high (UMRA) of 1995 (Pub. L. 104–4). This authority of Section 503 of Public Law consequence events, more responsible notice does not trigger the requirement 100–71, 5 U.S.C. Section 7301, and workforce in positions of public trust, for a written statement under section Executive Order No. 12564, establishes and potentially reducing individuals’ 202(a) of the UMRA because the the scientific and technical guidelines dependence or addiction and the Guidelines do not impose a mandate for federal workplace drug testing personal benefits associated with those that results in an expenditure of $100 programs and establishes standards for conditions. million (adjusted annually for inflation) certification of laboratories engaged in Considering the potential health and or more by either state, local, and tribal urine drug testing for federal agencies. performance costs of narcotic abuse, the governments in the aggregate or by the Because the Mandatory Guidelines benefits to the federal workplace and private sector in any one year. govern standards applicable to the management of federal agency the individuals within that workplace Environmental Impact justify the inclusion of oxycodone, personnel, there should be little, if any, oxymorphone, hydrocodone and The Secretary has considered the direct effect on the states, on the hydromorphone in Federal Workplace environmental effects of the UrMG. No relationship between the national Drug Testing programs. information or comments have been government and the states, or on the received that would affect the agency’s distribution of power and Regulatory Flexibility Analysis determination there would be a responsibilities among the various For the reasons outlined above, the significant impact on the human levels of government. Accordingly, the Secretary has determined that the environment and that neither an Secretary has determined that the Guidelines will not have a significant environmental assessment nor an Guidelines do not contain policies that impact upon a substantial number of environmental impact statement is have federalism implications. small entities within the meaning of the required. Regulatory Flexibility Act [5 U.S.C. Paperwork Reduction Act of 1995 Executive Order 13132: Federalism 605(b)]. The flexibility added by the The Guidelines contain information UrMG will not require addition The Secretary has analyzed the collection requirements which are expenditures. Therefore, a final Guidelines in accordance with subject to review by the Office of regulatory flexibility analysis is not Executive Order 13132: Federalism. Management and Budget (OMB) under required for this notice. Executive Order 13132 requires federal the Paperwork Reduction Act of 1995 The Secretary has determined that the agencies to carefully examine actions to [the PRA 44 U.S.C. 3507(d)]. Guidelines are not a major rule for the determine if they contain policies that Information collection and purpose of congressional review. For the have federalism implications or that recordkeeping requirements which purpose of congressional review, a preempt state law. As defined in the would be imposed on laboratories major rule is one which is likely to Order, ‘‘policies that have federalism engaged in drug testing for federal cause an annual effect on the economy implications’’ refer to regulations, agencies concern quality assurance and

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quality control documentation, reports, further changed to October 1, 2010 on Information Checklist, and performance testing, and inspections as April 30, 2010 [75 FR 22809]. recordkeeping requirements in the set out in subparts H, I, K, L, M and N. current Guidelines, as approved under Executive Order 13175: Consultation control number 0930–0158, will remain Information collection and and Coordination With Indian Tribal in effect until these final Guidelines are recordkeeping requirements which Governments would be imposed on MROs engaged in effective and OMB approves the revised drug testing services for federal agencies Executive Order 13175 (65 FR 67249, information collection. OMB will assign concern drug testing result review and November 6, 2000) requires SAMHSA to a new control number to account for reports as set out in subparts M and N. develop an accountable process to changes associated with the final To facilitate ease of use and uniform ensure ‘‘meaningful and timely input by Guidelines. reporting, a Federal CCF for each type tribal officials in the development of The title, description and respondent of specimen collected will be developed regulatory policies that have tribal description of the information as referenced in section 6.1. The implications.’’ ‘‘Policies that have tribal collections are shown in the following Department will submit the information implications’’ as defined in the paragraphs with an estimate of the collection and recordkeeping Executive Order, include regulations annual reporting, disclosure and requirements contained in the that have ‘‘substantial direct effects on recordkeeping burden. Included in the Guidelines to OMB for review and one or more Indian tribes, on the estimate is the time for reviewing approval prior to the effective date of relationship between the federal instructions, searching existing data the final Guidelines. Information government and the Indian tribes, or on sources, gathering and maintaining the collections changed by these Guidelines the distribution of power and data needed, and completing and are not effective until approved by responsibilities between the federal reviewing the collection of information. OMB. government and Indian tribes.’’ The Title: The Mandatory Guidelines for Guidelines do not have tribal Federal Workplace Drug Testing Privacy Act implications. The Guidelines will not Programs using Urine Specimens have substantial direct effects on tribal Description: The Mandatory The Secretary has determined that the governments, on the relationship Guidelines establish the scientific and Guidelines do not contain information between the federal government and technical guidelines for federal drug collection requirements constituting a Indian tribes, or on the distribution of testing programs and establish standards system of records under the Privacy Act. power and responsibilities between the for certification of laboratories engaged The Federal Register notice announcing federal government and Indian tribes, as in drug testing for federal agencies the Mandatory Guidelines for Federal specified in Executive Order 13175. under authority of Public Law 100–71, Workplace Drug Testing Programs using 5 U.S.C. 7301 note, and Executive Order Information Collection/Record Keeping Urine is not a system of records as noted No. 12564. Federal drug testing Requirements in the information collection/ programs test applicants to sensitive recordkeeping requirements below. As The information collection positions, individuals involved in required, HHS originally published the requirements (i.e., reporting and accidents, individuals for cause, and Mandatory Guidelines for Federal recordkeeping) in the current random testing of persons in sensitive Workplace Drug Testing Programs Guidelines (73 FR 71858) are approved positions. (Guidelines) in the Federal Register on by the Office of Management and Description of Respondents: April 11, 1988 [53 FR 11979]. SAMHSA Budget (OMB) under control number Individuals or households; businesses; subsequently revised the Guidelines on 0930–0158. The Federal Drug Testing or other-for-profit; not-for-profit June 9, 1994 [59 FR 29908], September Custody and Control Form used to institutions. 30, 1997 [62 FR 51118], November 13, document the collection and chain of The burden estimates in the tables 1998 [63 FR 63483], April 13, 2004 [69 custody of urine specimens at the below are based on the following FR 19644], and November 25, 2008 [73 collection site, for laboratories to report number of respondents: 38,000 donors FR 71858] with an effective date of May results, and for Medical Review Officers who apply for employment in testing 1, 2010 (correct effective date published to make a determination, the National designated positions, 100 collectors, 30 on December 10, 2008 [73 FR 75122]). Laboratory Certification Program (NLCP) urine specimen testing laboratories, 1 The effective date of the Guidelines was application, the NLCP Laboratory IITF, and 100 MROs.

ESTIMATE OF ANNUAL REPORTING BURDEN

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

9.2(a)(1) ...... Laboratory or IITF 1 required to submit application 10 1 3...... 30 for certification. 9.12(a)(3) ...... Materials to submit to become an HHS inspector 10 1 2 ...... 20 11.3(a) ...... Laboratory submits qualifications of RP to HHS .. 10 1 2 ...... 20 11.4(c) ...... Laboratory submits information to HHS on new 10 1 2...... 20 RP or alternate RP. 11.22 ...... Specifications for laboratory semi-annual statis- 10 5 0.5...... 25 tical report of test results to each federal agen- cy. 12.3(a) ...... IITF1 submits qualifications of RT to HHS ...... 1 1 1 ...... 1 12.4(c) ...... IITF1 submits information to HHS on new RT or 1 1 1...... 1 alternate RT. 12.19 ...... Specifications for IITF 1 semi-annual statistical re- 1 1 1...... 1 port of test results to each federal agency.

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ESTIMATE OF ANNUAL REPORTING BURDEN—Continued

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

13.9 and 14.7 ...... Specifies that MRO must report all verified pri- 100 14 0.05 (3 min) 70 mary and split specimen test results to the fed- eral agency. 16.1(b) & 16.5(a) ...... Specifies content of request for informal review of 1 1 3...... 3 suspension/proposed revocation of certification. 16.4 ...... Specifies information appellant provides in first 1 1 0.5...... 0.5 written submission when laboratory suspen- sion/revocation is proposed. 16.6 ...... Requires appellant to notify reviewing official of 1 1 0.5...... 0.5 resolution status at end of abeyance period. 16.7(a) ...... Specifies contents of appellant submission for re- 1 1 50...... 50 view. 16.9(a) ...... Specifies content of appellant request for expe- 1 1 3...... 3 dited review of suspension or proposed rev- ocation. 16.9(c) ...... Specifies contents of review file and briefs ...... 1 1 50 ...... 50

Total ...... 159 ...... 295 1 Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not received any IITF applications for certification to test federally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The following reporting requirements [Section 10.3(a)]; MRO notifies the actions an MRO takes for the medical are also in the Guidelines, but have not federal agency and HHS when an error evaluation of a donor who cannot been addressed in the above reporting occurs on a blind sample [Section provide a urine specimen. SAMHSA has burden table: Collector must report any 10.4(c)]; Section 13.5 describes the not calculated a separate reporting unusual donor behavior or refusal to actions an MRO takes to report a burden for these requirements because participate in the collection process on primary specimen result; Section 14.6 they are included in the burden hours the Federal CCF [Sections 1.8, 8.9]; describes the actions an MRO takes to estimated for collectors to complete collector annotates the Federal CCF report a split specimen result; and Federal CCFs and for MROs to report when a sample is a blind sample Sections 13.6 and 13.7 describe the results to federal agencies.

ESTIMATE OF ANNUAL DISCLOSURE BURDEN

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

8.3(a), 8.5(f)(2) (iii), Collector must contact federal agency point of 100 1 0.05 (3 min) 5 8.6(b)(2). contact. 11.23, 11.24 ...... Information on drug test that laboratory must pro- 50 10 3...... 1,500 vide to federal agency upon request or to donor through MRO. 12.20, 12.21 ...... Information on drug test that IITF1 must provide 1 1 1...... 1 to federal agency upon request or to donor through MRO. 13.8(b) ...... MRO must inform donor of right to request split 100 14 3...... 4,200 specimen test when a positive, adulterated, or substituted result is reported.

Total ...... 211 ...... 5,706 1 Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not certified any IITFs to test feder- ally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The following disclosure The collector must explain the basic collector explain the collection requirements are also included in the collection procedure to the donor and procedure to the donor and answer any Guidelines, but have not been addressed answer any questions [Section 8.3(e) questions is a standard business practice in the above disclosure burden table: and (g)]. SAMHSA believes having the and not a disclosure burden.

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

8.3, 8.5, 8.8 ...... Collector completes Federal CCF for specimen 100 380 0.07 (4 min) 2,534 collected. 8.8(d) & (f) ...... Donor initials specimen labels/seals and signs 38,000 1 0.08 (5 min) 3,167 statement on the Federal CCF.

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ESTIMATE OF ANNUAL RECORDKEEPING BURDEN—Continued

Number of Responses/ Hours/ Section Purpose respondents respondent response Total hours

11.8(a) & 11.19 ...... Laboratory completes Federal CCF upon receipt 10 3,800 0.05 (3 min) 1,900 of specimen and before reporting result. 12.8(a) & 12.15 ...... IITF1 completes Federal CCF upon receipt of 1 1 1...... 1 specimen and before reporting result. 13.4(d)(4),13.9(c),14.7(c) MRO completes Federal CCF before reporting 100 380 0.05 (3 min) 1,900 the primary or split specimen result. 14.1(b) ...... MRO documents donor’s request to have split 300 1 0.05 (3 min) 15 specimen tested.

Total ...... 38,511 ...... 9,517 1 Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not certified any IITFs to test feder- ally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The Guidelines contain a number of scientific supportability of the test metabolism and excretion patterns of recordkeeping requirements that results. Therefore, they are considered hydrocodone in urine following SAMHSA considers not to be an to be standard business practice and are controlled single dose administration. J. additional recordkeeping burden. In not considered a burden for this Anal. Toxicol, 37, 486–494. subpart D, a trainer is required to 3. Esposito, F.M., Mitchell, J.M., Baylor, analysis. M.R., Bush, D.M, 2006. Influence of basic document the training of an individual Thus the total annual response pH on federal regulated drugs in urine at to be a collector [Section 4.3(a)(3)] and burden associated with the testing of room temperature. Poster presented at the documentation must be maintained urine specimens by the laboratories and the Society of Forensic Toxicologists in the collector’s training file [Section IITFs is estimated to be 15,518 hours (SOFT) Annual Meeting, Austin, TX. 4.3(c)]. Because this is required by the (that is, the sum of the total hours from October 2006. current Guidelines and is consistent the above tables). This is in addition to 4. Cone, E.J., Bigelow, G.E., Herrmann, E.S., with general forensic requirements, the 1,788,809 hours currently approved Mitchell, J.M., LoDico, C., Flegel, R., SAMHSA believes this training by OMB under control number 0930– Vandrey, R, 2015. Nonsmoker exposure documentation is common practice and 0158 for urine testing under the current to secondhand cannabis smoke. III. oral is not considered an additional burden. fluid and blood concentrations and Guidelines. corresponding subjective effects. J. Anal. In subpart F, if a collector uses an As required by section 3507(d) of the Toxicol, 39, 497–509. incorrect form to collect a federal PRA, the Secretary submitted a copy of 5. Hermann, E.S, Cone, E.J., Mitchell, J.M., agency specimen, the collector is these proposed Guidelines to OMB for Bigelow, G.E., LoDico, C., Flegel, R., required to provide a statement [Section its review. Comments on the Vandrey, R., 2016. Non-smoker exposure 6.2(b)] explaining why an incorrect form information collection requirements to secondhand cannabis smoke II: Effect was used to document collecting the were specifically solicited in order to: of room ventilation on the physiological, specimen. SAMHSA believes this is an (1) Evaluate whether the proposed subjective, and behavioral/cognitive extremely infrequent occurrence and collection of information is necessary effects. Drug alcohol depend, 151, 194– does not create a significant additional for the proper performance of HHS’s 202. recordkeeping burden. Subpart H functions, including whether the Dated: January 11, 2017. [Sections 8.4(c), 8.5(d)(2), 8.5(e)(1) and information will have practical utility; Kana Enomoto, (2)] requires collectors to enter any (2) evaluate the accuracy of HHS’s Acting Deputy Assistant Secretary for Mental information on the Federal CCF of any estimate of the burden of the proposed Health and Substance Use, SAMHSA. unusual findings during the urine collection of information, including the Dated: January 11, 2017. specimen collection procedure. These validity of the methodology and Sylvia M. Burwell recordkeeping requirements are an assumptions used; (3) enhance the Secretary. integral part of the collection procedure quality, utility, and clarity of the and are essential to documenting the information to be collected; and (4) The Mandatory Guidelines using chain of custody for the specimens minimize the burden of the collection of Urine Specimens as revised are hereby collected. The burden for these entries information on those who are to adopted in accordance with section 503 are included in the recordkeeping respond, including through the use of of Public Law 100–71 and Executive burden estimated to complete the appropriate automated, electronic, Order 12564. Federal CCF and is, therefore, not mechanical, or other technological Mandatory Guidelines for Federal considered an additional recordkeeping collection techniques or other forms of Workplace Drug Testing Programs burden. Subpart K describes a number information technology. Using Urine Specimens of recordkeeping requirements for laboratories associated with their testing References Subpart A—Applicability procedures, maintaining chain of 1. Cone, E.J., Heltsley, R., Black, D.L., 1.1 To whom do these Guidelines apply? custody, and keeping records [i.e., Mitchell, J.M., LoDico, C.P., Flegel, R.R, 1.2 Who is responsible for developing and Sections 11.1(a) and (d); 11.2(b), (c), and 2013. Prescription opioids. I. metabolism implementing these Guidelines? (d); 11.6(b); 11.7(c); 11.8; 11.11(a); and excretion patterns of oxycodone in 1.3 How does a federal agency request a change from these Guidelines? 11.14(a); 11.17; 11.21(a), (b), and (c); urine following controlled single dose administration. J. Anal. Toxicol, 37, 255– 1.4 How are these Guidelines revised? 11.22; 11.23(a) and 11.24. These 264. 1.5 What do the terms used in these recordkeeping requirements are 2. Cone, E.J., Heltsley. R., Black, D.L., Guidelines mean? necessary for any laboratory to conduct Mitchell, J.M., LoDico, C.P., Flegel, R.R, 1.6 What is an agency required to do to forensic drug testing and to ensure the 2013. Prescription opioids. II. protect employee records?

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1.7 What is a refusal to take a federally Subpart G—Urine Specimen Collection laboratory or IITF and when may the regulated drug test? Containers and Bottles inspection be conducted? 1.8 What are the potential consequences for 7.1 What is used to collect a urine 9.13 What happens if an applicant refusing to take a federally regulated specimen? laboratory or IITF does not satisfy the drug test? 7.2 What are the requirements for a urine minimum requirements for either the PT program or the inspection program? Subpart B—Urine Specimens collection container and specimen bottles? 9.14 What happens if an HHS-certified 2.1 What type of specimen may be 7.3 What are the minimum performance laboratory or IITF does not satisfy the collected? requirements for a urine collection minimum requirements for either the PT 2.2 Under what circumstances may a urine container and specimen bottles? program or the inspection program? specimen be collected? 9.15 What factors are considered in 2.3 How is each urine specimen collected? Subpart H—Urine Specimen Collection determining whether revocation of a 2.4 What volume of urine is collected? Procedure laboratory’s or IITF’s HHS certification is 2.5 How does the collector split the urine 8.1 What privacy must the donor be given necessary? specimen? when providing a urine specimen? 9.16 What factors are considered in 2.6 When may an entity or individual 8.2 What must the collector ensure at the determining whether to suspend a release a urine specimen? collection site before starting a urine laboratory’s or an IITF’s HHS specimen collection? certification? Subpart C—Urine Specimen Tests 8.3 What are the preliminary steps in the 9.17 How does the Secretary notify an HHS- 3.1 Which tests are conducted on a urine urine specimen collection procedure? certified laboratory or IITF that action is specimen? 8.4 What steps does the collector take in the being taken against the laboratory or 3.2 May a specimen be tested for additional collection procedure before the donor IITF? drugs? provides a urine specimen? 9.18 May a laboratory or IITF that had its 3.3 May any of the specimens be used for 8.5 What steps does the collector take HHS certification revoked be recertified other purposes? during and after the urine specimen to test federal agency specimens? 3.4 What are the drug test cutoff collection procedure? 9.19 Where is the list of HHS-certified concentrations for urine? 8.6 What procedure is used when the donor laboratories and IITFs published? 3.5 May an HHS-certified laboratory states that they are unable to provide a Subpart J—Blind Samples Submitted by an perform additional drug and/or urine specimen? Agency specimen validity tests on a specimen at 8.7 If the donor is unable to provide a urine the request of the Medical Review specimen, may another specimen type be 10.1 What are the requirements for federal Officer (MRO)? collected for testing? agencies to submit blind samples to 3.6 What criteria are used to report a urine 8.8 How does the collector prepare the HHS-certified laboratories or IITFs? specimen as adulterated? urine specimens? 10.2 What are the requirements for blind 3.7 What criteria are used to report a urine 8.9 When is a direct observed collection samples? specimen as substituted? conducted? 10.3 How is a blind sample submitted to an 3.8 What criteria are used to report a urine 8.10 How is a direct observed collection HHS-certified laboratory or IITF? specimen as dilute? conducted? 10.4 What happens if an inconsistent result 3.9 What criteria are used to report an 8.11 When is a monitored collection is reported for a blind sample? invalid result for a urine specimen? conducted? 8.12 How is a monitored collection Subpart K—Laboratory Subpart D—Collectors conducted? 11.1 What must be included in the HHS- 4.1 Who may collect a specimen? 8.13 How does the collector report a certified laboratory’s standard operating 4.2 Who may not collect a specimen? donor’s refusal to test? procedure manual? 4.3 What are the requirements to be a 8.14 What are a federal agency’s 11.2 What are the responsibilities of the collector? responsibilities for a collection site? responsible person (RP)? 4.4 What are the requirements to be an 11.3 What scientific qualifications must the Subpart I—HHS Certification of Laboratories RP have? observer for a direct observed collection? and IITFs 4.5 What are the requirements to be a 11.4 What happens when the RP is absent trainer for collectors? 9.1 Who has the authority to certify or leaves an HHS-certified laboratory? 4.6 What must a federal agency do before a laboratories and IITFs to test urine 11.5 What qualifications must an individual collector is permitted to collect a specimens for federal agencies? have to certify a result reported by an specimen? 9.2 What is the process for a laboratory or HHS-certified laboratory? IITF to become HHS-certified? 11.6 What qualifications and training must Subpart E—Collection Sites 9.3 What is the process for a laboratory or other personnel of an HHS-certified 5.1 Where can a collection for a drug test IITF to maintain HHS certification? laboratory have? take place? 9.4 What is the process when a laboratory 11.7 What security measures must an HHS- 5.2 What are the requirements for a or IITF does not maintain its HHS certified laboratory maintain? collection site? certification? 11.8 What are the laboratory chain of 5.3 Where must collection site records be 9.5 What are the qualitative and custody requirements for specimens and stored? quantitative specifications of aliquots? 5.4 How long must collection site records performance testing (PT) samples? 11.9 What test(s) does an HHS-certified be stored? 9.6 What are the PT requirements for an laboratory conduct on a urine specimen 5.5 How does the collector ensure the applicant laboratory? received from an IITF? security and integrity of a specimen at 9.7 What are the PT requirements for an 11.10 What are the requirements for an the collection site? HHS-certified urine laboratory? initial drug test? 5.6 What are the privacy requirements 9.8 What are the PT requirements for an 11.11 What must an HHS-certified when collecting a urine specimen? applicant IITF? laboratory do to validate an initial drug 9.9 What are the PT requirements for an test? Subpart F—Federal Drug Testing Custody HHS-certified IITF? 11.12 What are the batch quality control and Control Form 9.10 What are the inspection requirements requirements when conducting an initial 6.1 What federal form is used to document for an applicant laboratory or IITF? drug test? custody and control? 9.11 What are the maintenance inspection 11.13 What are the requirements for a 6.2 What happens if the correct OMB- requirements for an HHS-certified confirmatory drug test? approved Federal CCF is not available or laboratory or IITF? 11.14 What must an HHS-certified is not used? 9.12 Who can inspect an HHS-certified laboratory do to validate a confirmatory

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drug test? 12.17 How long must an HHS-certified IITF IITF to report a specimen as rejected for 11.15 What are the batch quality control retain a specimen? testing? requirements when conducting a 12.18 How long must an HHS-certified IITF 15.2 What discrepancies require an HHS- confirmatory drug test? retain records? certified laboratory or an HHS-certified 11.16 What are the analytical and quality 12.19 What statistical summary report must IITF to report a specimen as rejected for control requirements for conducting an HHS-certified IITF provide? testing unless the discrepancy is specimen validity tests? 12.20 What HHS-certified IITF information corrected? 11.17 What must an HHS-certified is available to a federal employee? 15.3 What discrepancies are not sufficient laboratory do to validate a specimen 12.21 What types of relationships are to require an HHS-certified laboratory or validity test? prohibited between an HHS-certified an HHS-certified IITF to reject a urine 11.18 What are the requirements for IITF and an MRO? specimen for testing or an MRO to cancel conducting each specimen validity test? 12.22 What type of relationship can exist a test? 11.19 What are the requirements for an between an HHS-certified IITF and an 15.4 What discrepancies may require an HHS-certified laboratory to report a test HHS-certified laboratory? MRO to cancel a test? result? Subpart M—Medical Review Officer (MRO) Subpart P—Laboratory or IITF Suspension/ 11.20 How long must an HHS-certified Revocation Procedures laboratory retain specimens? 13.1 Who may serve as an MRO? 11.21 How long must an HHS-certified 13.2 How are nationally recognized entities 16.1 When may the HHS certification of a laboratory retain records? or subspecialty boards that certify MROs laboratory or IITF be suspended? 11.22 What statistical summary reports approved? 16.2 What definitions are used for this must an HHS-certified laboratory 13.3 What training is required before a subpart? provide for urine testing? physician may serve as an MRO? 16.3 Are there any limitations on issues subject to review? 11.23 What HHS-certified laboratory 13.4 What are the responsibilities of an 16.4 Who represents the parties? information is available to a federal MRO? 16.5 When must a request for informal agency? 13.5 What must an MRO do when review be submitted? 11.24 What HHS-certified laboratory reviewing a urine specimen’s test 16.6 What is an abeyance agreement? information is available to a federal results? 13.6 What action does the MRO take when 16.7 What procedures are used to prepare employee? the review file and written argument? 11.25 What types of relationships are the collector reports that the donor did not provide a sufficient amount of urine 16.8 When is there an opportunity for oral prohibited between an HHS-certified presentation? laboratory and an MRO? for a drug test? 13.7 What happens when an individual is 16.9 Are there expedited procedures for 11.26 What type of relationship can exist review of immediate suspension? between an HHS-certified laboratory and unable to provide a sufficient amount of urine for a federal agency applicant/pre- 16.10 Are any types of communications an HHS-certified IITF? employment test, a follow-up test, or a prohibited? Subpart L—Instrumented Initial Test return-to-duty test because of a 16.11 How are communications transmitted Facility (IITF) permanent or long-term medical by the reviewing official? 16.12 What are the authority and 12.1 What must be included in the HHS- condition? 13.8 Who may request a test of a split (B) responsibilities of the reviewing official? certified IITF’s standard operating 16.13 What administrative records are procedure manual? specimen? 13.9 How does an MRO report a primary maintained? 12.2 What are the responsibilities of the 16.14 What are the requirements for a responsible technician (RT)? (A) specimen test result to an agency? 13.10 What types of relationships are written decision? 12.3 What qualifications must the RT have? prohibited between an MRO and an 16.15 Is there a review of the final 12.4 What happens when the RT is absent HHS-certified laboratory or an HHS- administrative action? or leaves an HHS-certified IITF? certified IITF? 12.5 What qualifications must an individual Subpart A—Applicability have to certify a result reported by an Subpart N—Split Specimen Tests Section 1.1 To whom do these HHS-certified IITF? 14.1 When may a split (B) specimen be Guidelines apply? 12.6 What qualifications and training must tested? other personnel of an HHS-certified IITF 14.2 How does an HHS-certified laboratory (a) These Guidelines apply to: have? test a split (B) specimen when the (1) Executive Agencies as defined in 12.7 What security measures must an HHS- primary (A) specimen was reported 5 U.S.C. 105; certified IITF maintain? positive? (2) The Uniformed Services, as 12.8 What are the IITF chain of custody 14.3 How does an HHS-certified laboratory defined in 5 U.S.C. 2101(3) (but requirements for specimens and test a split (B) urine specimen when the excluding the Armed Forces as defined aliquots? primary (A) specimen was reported in 5 U.S.C. 2101(2)); 12.9 What are the requirements for an adulterated? (3) Any other employing unit or initial drug test? 14.4 How does an HHS-certified laboratory 12.10 What must an HHS-certified IITF do authority of the federal government test a split (B) urine specimen when the except the United States Postal Service, to validate an initial drug test? primary (A) specimen was reported 12.11 What are the batch quality control substituted? the Postal Rate Commission, and requirements when conducting an initial 14.5 Who receives the split (B) specimen employing units or authorities in the drug test? result? Judicial and Legislative Branches; and 12.12 What are the analytical and quality 14.6 What action(s) does an MRO take after (4) The Intelligence Community, as control requirements for conducting receiving the split (B) urine specimen defined by Executive Order 12333, is specimen validity tests? result from the second HHS-certified subject to these Guidelines only to the 12.13 What must an HHS-certified IITF do laboratory? extent agreed to by the head of the to validate a specimen validity test? 14.7 How does an MRO report a split (B) affected agency; 12.14 What are the requirements for specimen test result to an agency? (5) Laboratories and instrumented conducting each specimen validity test? 14.8 How long must an HHS-certified initial test facilities (IITFs) that provide 12.15 What are the requirements for an laboratory retain a split (B) specimen? HHS-certified IITF to report a test result? drug testing services to the federal 12.16 How does an HHS-certified IITF Subpart O—Criteria for Rejecting a agencies; handle a specimen that tested positive, Specimen for Testing (6) Collectors who provide specimen adulterated, substituted, or invalid at the 15.1 What discrepancies require an HHS- collection services to the federal IITF? certified laboratory or an HHS-certified agencies; and

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(7) Medical Review Officers (MROs) Section 1.5 What do the terms used in concentration) is affected by a preceding who provide drug testing review and these Guidelines mean? sample during the preparation or interpretation of results services to the The following definitions are adopted: analysis of a sample. federal agencies. Accessioner. The individual who Certifying Scientist (CS). The (b) These Guidelines do not apply to signs the Federal Drug Testing Custody individual responsible for verifying the drug testing under authority other than and Control Form at the time of chain of custody and scientific Executive Order 12564, including specimen receipt at the HHS-certified reliability of a test result reported by an testing of persons in the criminal justice laboratory or (for urine) the HHS- HHS-certified laboratory. system, such as arrestees, detainees, certified IITF. Certifying Technician (CT). The probationers, incarcerated persons, or Adulterated Specimen. A specimen individual responsible for verifying the parolees.1 that has been altered, as evidenced by chain of custody and scientific test results showing either a substance reliability of negative, rejected for Section 1.2 Who is responsible for that is not a normal constituent for that testing, and (for urine) negative/dilute developing and implementing these type of specimen or showing an results reported by an HHS-certified Guidelines? abnormal concentration of an laboratory or (for urine) an HHS- (a) Executive Order 12564 and Public endogenous substance. certified IITF. Law 100–71 require the Department of Aliquot. A portion of a specimen used Chain of Custody (COC) Procedures. Health and Human Services (HHS) to for testing. Procedures that document the integrity establish scientific and technical Alternate Responsible Person. The of each specimen or aliquot from the guidelines for federal workplace drug person who assumes professional, point of collection to final disposition. Chain of Custody Documents. Forms testing programs. organizational, educational, and administrative responsibility for the used to document the control and (b) The Secretary has the day-to-day management of the HHS- security of the specimen and all responsibility to implement these certified laboratory when the aliquots. The document may account for Guidelines. responsible person is unable to fulfill an individual specimen, aliquot, or Section 1.3 How does a federal agency these obligations. batch of specimens/aliquots and must request a change from these Guidelines? Alternate Responsible Technician. include the name and signature of each The person who assumes professional, individual who handled the specimen(s) (a) Each federal agency must ensure organizational, educational, and or aliquot(s) and the date and purpose that its workplace drug testing program administrative responsibility for the of the handling. complies with the provisions of these day-to-day management of the HHS- Collection Container. A receptacle Guidelines unless a waiver has been certified IITF when the responsible used to collect a urine specimen. obtained from the Secretary. technician is unable to fulfill these Collection Site. The location where (b) To obtain a waiver, a federal obligations. specimens are collected. agency must submit a written request to Alternate Technology Initial Drug Collector. A person trained to instruct the Secretary that describes the specific Test. An initial drug test using and assist a donor in providing a change for which a waiver is sought and technology other than immunoassay to specimen. a detailed justification for the change. differentiate negative specimens from Confirmatory Drug Test. A second analytical procedure performed on a Section 1.4 How are these Guidelines those requiring further testing. Batch. A number of specimens or separate aliquot of a specimen to revised? aliquots handled concurrently as a identify and quantify a specific drug or (a) To ensure the full reliability and group. drug metabolite. accuracy of specimen tests, the accurate Biomarker. An endogenous substance Confirmatory Specimen Validity Test. reporting of test results, and the used to validate a biological specimen. A second test performed on a separate integrity and efficacy of federal drug Blind Sample. A sample submitted to aliquot of a specimen to further support testing programs, the Secretary may an HHS-certified test facility for quality a specimen validity test result. make changes to these Guidelines to assurance purposes, with a fictitious Control. A sample used to evaluate reflect improvements in the available identifier, so that the test facility cannot whether an analytical procedure or test science and technology. distinguish it from a donor specimen. is operating within predefined tolerance (b) The changes will be published in Calibrator. A sample of known limits. Cutoff. The analytical value (e.g., drug final as a notice in the Federal Register. content and analyte concentration prepared in the appropriate matrix used or drug metabolite concentration) used to define expected outcomes of a testing as the decision point to determine a 1 The NRC-related information in this notice pertains to individuals subject to drug testing procedure. The test result of the result (e.g., negative, positive, conducted pursuant to 10 CFR part 26, ‘‘Fitness for calibrator is verified to be within adulterated, invalid, or, for urine, Duty Programs’’ (i.e., employees of certain NRC- established limits prior to use. substituted) or the need for further regulated entities). Cancelled Test. The result reported by testing. Although HHS has no authority to regulate the the MRO to the federal agency when a Dilute Specimen. A urine specimen transportation industry, the Department of Transportation (DOT) does have such authority. specimen has been reported to the MRO with creatinine and specific gravity DOT is required by law to develop requirements for as an invalid result (and the donor has values that are lower than expected but its regulated industry that ‘‘incorporate the no legitimate explanation) or rejected are still within the physiologically Department of Health and Human Services for testing, when a split specimen fails producible ranges of human urine. scientific and technical guidelines dated April 11, 1988, and any amendments to those guidelines to reconfirm, or when the MRO Donor. The individual from whom a . . .’’ See 49 U.S.C. 20140(c)(2). In carrying out its determines that a fatal flaw or specimen is collected. mandate, DOT requires by regulation at 49 CFR part unrecovered correctable flaw exists in External Service Provider. An 40 that its federally-regulated employers use only the forensic records (as described in independent entity that performs HHS-certified laboratories in the testing of services related to federal workplace employees, 49 CFR 40.81, and incorporates the Sections 15.1 and 15.2). scientific and technical aspects of the HHS Carryover. The effect that occurs drug testing on behalf of a federal Mandatory Guidelines. when a sample result (e.g., drug agency, a collector/collection site, an

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HHS-certified laboratory, a Medical time for which the manufacturer Specimen. Fluid or material collected Review Officer (MRO), or, for urine, an ensures that the items have essentially from a donor at the collection site for HHS-certified Instrumented Initial Test the same performance characteristics the purpose of a drug test. Facility (IITF). and expiration date. Split Specimen Collection (for Urine). Failed to Reconfirm. The result Medical Review Officer (MRO). A A collection in which the specimen reported for a split (B) specimen when licensed physician who reviews, collected is divided into a primary (A) a second HHS-certified laboratory is verifies, and reports a specimen test specimen and a split (B) specimen, unable to corroborate the result reported result to the federal agency. which are independently sealed in the for the primary (A) specimen. Negative Result. The result reported presence of the donor. Federal Drug Testing Custody and by an HHS-certified laboratory or (for Standard. Reference material of Control Form (Federal CCF). The Office urine) an HHS-certified IITF to an MRO known purity or a solution containing a of Management and Budget (OMB) when a specimen contains no drug and/ reference material at a known approved form that is used to document or drug metabolite; or the concentration concentration. the collection and chain of custody of a of the drug or drug metabolite is less Substituted Specimen. A specimen specimen from the time the specimen is than the cutoff for that drug or drug that has been submitted in place of the collected until it is received by the test class. donor’s urine, as evidenced by facility (i.e., HHS-certified laboratory or, Oral Fluid Specimen. An oral fluid creatinine and specific gravity values for urine, HHS-certified IITF). It may be specimen is collected from the donor’s that are outside the physiologically a paper (hardcopy), electronic, or oral cavity and is a combination of producible ranges of human urine. combination electronic and paper physiological fluids produced primarily Section 1.6 What is an agency required format (hybrid). The form may also be by the salivary glands. to do to protect employee records? used to report the test result to the Oxidizing Adulterant. A substance Consistent with 5 U.S.C. 552a and 48 Medical Review Officer. that acts alone or in combination with CFR 24.101–24.104, all agency contracts Gender Identity. Gender identity other substances to oxidize drug or drug with laboratories, IITFs, collectors, and means an individual’s internal sense of metabolites to prevent the detection of MROs must require that they comply being male or female, which may be the drugs or drug metabolites, or affects with the Privacy Act, 5 U.S.C. 552a. In different from an individual’s sex the reagents in either the initial or addition, the contracts must require assigned at birth. confirmatory drug test. compliance with employee access and HHS. The Department of Health and Performance Testing (PT) Sample. A confidentiality provisions of Section Human Services. program-generated sample sent to a 503 of Public Law 100–71. Each federal Initial Drug Test. An analysis used to laboratory or (for urine) to an IITF to agency must establish a Privacy Act differentiate negative specimens from evaluate performance. those requiring further testing. System of Records or modify an existing Positive Result. The result reported by Initial Specimen Validity Test. The system or use any applicable an HHS-certified laboratory when a first analysis used to determine if a Government-wide system of records to specimen contains a drug or drug specimen is invalid, adulterated, or (for cover the records of employee drug test metabolite equal to or greater than the urine) diluted or substituted. results. All contracts and the Privacy Instrumented Initial Test Facility confirmation cutoff concentration. Act System of Records must specifically (IITF). A permanent location where (for Reconfirmed. The result reported for require that employee records be urine) initial testing, reporting of a split (B) specimen when the second maintained and used with the highest results, and recordkeeping are HHS-certified laboratory corroborates regard for employee privacy. performed under the supervision of a the original result reported for the The Health Insurance Portability and responsible technician. primary (A) specimen. Accountability Act of 1996 (HIPAA) Invalid Result. The result reported by Rejected for Testing. The result Privacy Rule (Rule), 45 CFR parts 160 an HHS-certified laboratory in reported by an HHS-certified laboratory and 164, Subparts A and E, may be accordance with the criteria established or (for urine) HHS-certified IITF when applicable to certain health care in Section 3.9 when a positive, negative, no tests are performed on a specimen providers with whom a federal agency adulterated, or substituted result cannot because of a fatal flaw or an may contract. If a health care provider be established for a specific drug or unrecovered correctable error (see is a HIPAA covered entity, the provider specimen validity test. Sections 15.1 and 15.2). must protect the individually Laboratory. A permanent location Responsible Person (RP). The person identifiable health information it where initial and confirmatory drug who assumes professional, maintains in accordance with the testing, reporting of results, and organizational, educational, and requirements of the Rule, which recordkeeping are performed under the administrative responsibility for the includes not using or disclosing the supervision of a responsible person. day-to-day management of an HHS- information except as permitted by the Limit of Detection. The lowest certified laboratory. Rule and ensuring there are reasonable concentration at which the analyte (e.g., Responsible Technician (RT). The safeguards in place to protect the drug or drug metabolite) can be person who assumes professional, privacy of the information. For more identified. organizational, educational, and information regarding the HIPAA Limit of Quantification. For administrative responsibility for the Privacy Rule, please visit http:// quantitative assays, the lowest day-to-day management of an HHS- www.hhs.gov/ocr/hipaa. concentration at which the identity and certified IITF. concentration of the analyte (e.g., drug Sample. A performance testing Section 1.7 What is a refusal to take a or drug metabolite) can be accurately sample, calibrator or control used federally regulated drug test? established. during testing, or a representative (a) As a donor for a federally regulated Lot. A number of units of an item portion of a donor’s specimen. drug test, you have refused to take a (e.g., reagents, quality control material) Secretary. The Secretary of the U.S. federally regulated drug test if you: manufactured from the same starting Department of Health and Human (1) Fail to appear for any test (except materials within a specified period of Services. a pre-employment test) within a

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reasonable time, as determined by the (13) Admit to the collector or MRO Section 2.3 How is each urine federal agency, consistent with that you have adulterated or substituted specimen collected? applicable agency regulations, after the specimen. Each urine specimen is collected as a being directed to do so by the federal Section 1.8 What are the potential split specimen as described in Section agency; 2.5. (2) Fail to remain at the collection site consequences for refusing to take a until the collection process is complete federally regulated drug test? Section 2.4 What volume of urine is with the exception of a donor who (a) As a federal agency employee or collected? leaves the collection site before the applicant, a refusal to take a test may A donor is expected to provide at collection process begins for a pre- result in the initiation of disciplinary or least 45 mL of urine for a specimen. employment test as described in section adverse action, up to and including 8.4(a); removal from, or non-selection for, Section 2.5 How does the collector (3) Fail to provide a specimen (e.g., federal employment. split the urine specimen? urine or another authorized specimen (b) When a donor has refused to The collector pours at least 30 mL type) for any drug test required by these participate in a part of the collection into a specimen bottle that is designated Guidelines or federal agency regulations process, including failing to appear in a as A (primary) and then pours at least with the exception of a donor who reasonable time for any test except a 15 mL into a specimen bottle that is leaves the collection site before the pre-employment test as described in designated as B (split). collection process begins for a pre- Section 1.7(a)(1), the collector must Section 2.6 When may an entity or employment test as described in section terminate the collection process and individual release a urine specimen? 8.4(a); take action as described in Section 8.13. (4) In the case of a direct observed or Required action includes immediately Entities and individuals subject to monitored collection, fail to permit the notifying the federal agency’s these Guidelines under Section 1.1 may observation or monitoring of your designated representative by any means not release specimens collected provision of a specimen when required (e.g., telephone or secure fax machine) pursuant to Executive Order 12564, as described in Sections 8.9 and 8.10; that ensures that the refusal notification Public Law 100–71, and these (5) Fail to provide a sufficient amount is immediately received and, if a Guidelines to donors or their designees. of urine when directed, and it has been Federal CCF has been initiated, Specimens also may not be released to determined, through a required medical documenting the refusal on the Federal any other entity or individual unless evaluation, that there was no legitimate CCF, signing and dating the Federal expressly authorized by these medical explanation for the failure as CCF, and sending all copies of the Guidelines or by applicable federal law. determined by the process described in Federal CCF to the federal agency’s This section does not prohibit a donor’s Section 13.6; designated representative. request to have a split (B) specimen (6) Fail or decline to participate in an (c) When documenting a refusal to tested in accordance with Section 13.8. alternate specimen collection (e.g., oral test during the verification process as fluid) as directed by the federal agency Subpart C—Urine Drug and Specimen described in Sections 13.4, 13.5, and or collector (i.e., as described in Section Validity Tests 13.6, the MRO must complete the MRO 8.6); copy of the Federal CCF to include: Section 3.1 Which tests are conducted (7) Fail to undergo a medical on a urine specimen? examination or evaluation, as directed (1) Checking the refusal to test box; by the MRO as part of the verification (2) Providing a reason for the refusal A federal agency: process (i.e., Section 13.6) or as directed in the remarks line; and (a) Must ensure that each specimen is by the federal agency. In the case of a (3) Signing and dating the MRO copy tested for marijuana and cocaine federal agency applicant/pre- of the Federal CCF. metabolites as provided under Section 3.4; employment drug test, the donor is Subpart B—Urine Specimens deemed to have refused to test on this (b) Is authorized to test each specimen basis only if the federal agency Section 2.1 What type of specimen for opioids, amphetamines, and applicant/pre-employment test is may be collected? phencyclidine, as provided under Section 3.4; and conducted following a contingent offer A federal agency may collect urine (c) Must ensure that the following of employment. If there was no and/or an alternate specimen type for its specimen validity tests are conducted contingent offer of employment, the workplace drug testing program. Only on each urine specimen: MRO will cancel the test; specimen types authorized by (1) Determine the creatinine (8) Fail to cooperate with any part of Mandatory Guidelines for Federal concentration on every specimen; the testing process (e.g., refuse to empty Workplace Drug Testing Programs may pockets when directed by the collector, (2) Determine the specific gravity on be collected. An agency using urine every specimen for which the creatinine disrupt the collection process, fail to must follow these Guidelines. wash hands after being directed to do so concentration is less than 20 mg/dL; by the collector); Section 2.2 Under what circumstances (3) Determine the pH on every (9) For an observed collection, fail to may a urine specimen be collected? specimen; and follow the observer’s instructions (4) Perform one or more specimen A federal agency may collect a urine validity tests for oxidizing adulterants related to the collection process; specimen for the following reasons: (10) Bring materials to the collection on every specimen. (a) Federal agency applicant/Pre- site for the purpose of adulterating, (d) If a specimen exhibits abnormal employment test; substituting, or diluting the specimen; characteristics (e.g., unusual odor or (11) Attempt to adulterate, substitute, (b) Random test; color, semi-solid characteristics), causes or dilute the specimen; (c) Reasonable suspicion/cause test; reactions or responses characteristic of (12) Possess or wear a prosthetic or (d) Post accident test; an adulterant during initial or other device that could be used to (e) Return to duty test; or confirmatory drug tests (e.g., non- interfere with the collection process; or (f) Follow-up test. recovery of internal standard, unusual

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response), or contains an unidentified validated initial and confirmatory Section 3.3 May any of the specimens substance that interferes with the analytical methods. If an initial test be used for other purposes? confirmatory analysis, then additional procedure is not available upon request testing may be performed. for a suspected Schedule I or Schedule (a) Specimens collected pursuant to II drug, the federal agency can request Executive Order 12564, Public Law Section 3.2 May a specimen be tested an HHS-certified laboratory to test for 100–71, and these Guidelines must only for additional drugs? the drug by analyzing two separate be tested for drugs and to determine (a) On a case-by-case basis, a aliquots of the specimen in two separate their validity in accordance with specimen may be tested for additional testing batches using the confirmatory Subpart C of these Guidelines. Use of drugs, if a federal agency is conducting analytical method. Additionally, the specimens by donors, their designees, or the collection for reasonable suspicion split (B) specimen will be available for any other entity, for other purposes (e.g., or post accident testing. A specimen testing if the donor requests a retest at deoxyribonucleic acid, DNA, testing) is collected from a federal agency another HHS-certified laboratory. prohibited unless authorized in employee may be tested by the federal (b) A federal agency covered by these accordance with applicable federal law. agency for any drugs listed in Schedule Guidelines must petition the Secretary I or II of the Controlled Substances Act. in writing for approval to routinely test (b) These Guidelines are not intended The federal agency must request the for any drug class not listed in Section to prohibit federal agencies specifically HHS-certified laboratory to test for the 3.1. Such approval must be limited to authorized by law to test a specimen for additional drug, include a justification the use of the appropriate science and additional classes of drugs in its to test a specific specimen for the drug, technology and must not otherwise limit workplace drug testing program. and ensure that the HHS-certified agency discretion to test for any drug Section 3.4 What are the drug test laboratory has the capability to test for tested under paragraph (a) of this cutoff concentrations for urine? the drug and has established properly section.

1 Confirmatory test Initial test analyte Initial test cutoff Confirmatory test analyte cutoff concentration

Marijuana metabolites (THCA) 2 .... 50 ng/mL 3 ...... THCA ...... 15 ng/mL. Cocaine metabolite 150 ng/mL 3 ...... Benzoylecgonine ...... 100 ng/mL. (Benzoylecgonine). Codeine/Morphine ...... 2,000 ng/mL ...... Codeine ...... 2,000 ng/mL. Morphine ...... 2,000 ng/mL. Hydrocodone/Hydromorphone ...... 300 ng/mL ...... Hydrocodone ...... 100 ng/mL. Hydromorphone ...... 100 ng/mL. Oxycodone/Oxymorphone ...... 100 ng/mL ...... Oxycodone ...... 100 ng/mL. Oxymorphone ...... 100 ng/mL. 6-Acetylmorphine ...... 10 ng/mL ...... 6-Acetylmorphine ...... 10 ng/mL. Phencyclidine ...... 25 ng/mL ...... Phencyclidine ...... 25 ng/mL. Amphetamine/Methamphetamine .. 500 ng/mL ...... Amphetamine ...... 250 ng/mL. Methamphetamine ...... 250 ng/mL. MDMA 4/MDA 5 ...... 500 ng/mL ...... MDMA ...... 250 ng/mL. MDA ...... 250 ng/mL. 1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group. Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test cutoff. 2 An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 3 Alternate technology (THCA and benzoylecgonine): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte (i.e., 15 ng/mL for THCA, 100 ng/mL for benzoylecgonine). 4 Methylenedioxymethamphetamine (MDMA). 5 Methylenedioxyamphetamine (MDA).

Section 3.5 May an HHS-certified validity tests at the request of an MRO (a) The pH is less than 4 or equal to laboratory perform additional drug and/ without prior authorization from the or greater than 11 using either a pH or specimen validity tests on a specimen Secretary or designated HHS meter or a colorimetric pH test for the at the request of the Medical Review representative, with the exception of the initial test on the first aliquot and a pH Officer (MRO)? determination of D,L stereoisomers of meter for the confirmatory test on the An HHS-certified laboratory is amphetamine and methamphetamine. second aliquot; All tests must meet appropriate authorized to perform additional drug (b) The nitrite concentration is equal validation and quality control and/or specimen validity tests on a case- to or greater than 500 mcg/mL using requirements in accordance with these by-case basis as necessary to provide either a nitrite colorimetric test or a Guidelines. information that the MRO would use to general oxidant colorimetric test for the report a verified drug test result (e.g., Section 3.6 What criteria are used to initial test on the first aliquot and a tetrahydrocannabivarin, specimen report a urine specimen as adulterated? different confirmatory test (e.g., multi- validity tests using biomarkers). An wavelength spectrophotometry, ion HHS-certified laboratory is not An HHS-certified laboratory reports a chromatography, capillary authorized to routinely perform primary (A) specimen as adulterated electrophoresis) on the second aliquot; additional drug and/or specimen when:

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(c) The presence of chromium (VI) is cutoff for the initial test on the first confirmatory specific gravity tests and verified using either a general oxidant aliquot and a different confirmatory test the creatinine concentration is equal to colorimetric test (with an equal to or (e.g., multi-wavelength or greater than 2 mg/dL on either or greater than 50 mcg/mL chromium (VI)- spectrophotometry) with an equal to or both the initial or confirmatory equivalent cutoff) or a chromium (VI) greater than 100 mcg/mL creatinine tests); colorimetric test (chromium (VI) dodecylbenzene sulfonate-equivalent (b) The pH is equal to or greater than concentration equal to or greater than 50 cutoff on the second aliquot; or 4 and less than 4.5 or equal to or greater mcg/mL) for the initial test on the first (h) The presence of any other than 9 and less than 11 using either a aliquot and a different confirmatory test adulterant not specified in paragraphs colorimetric pH test or pH meter for the (e.g., multi-wavelength (b) through (g) of this section is verified initial test and a pH meter for the spectrophotometry, ion using an initial test on the first aliquot confirmatory test on two separate chromatography, atomic absorption and a different confirmatory test on the aliquots; spectrophotometry, capillary second aliquot. (c) The nitrite concentration is equal electrophoresis, inductively coupled to or greater than 200 mcg/mL using a plasma-mass spectrometry) with the Section 3.7 What criteria are used to report a urine specimen as substituted? nitrite colorimetric test or equal to or chromium (VI) concentration equal to or greater than the equivalent of 200 mcg/ greater than the limit of quantitation An HHS-certified laboratory reports a mL nitrite using a general oxidant (LOQ) of the confirmatory test on the primary (A) specimen as substituted colorimetric test for both the initial second aliquot; when the creatinine concentration is (first) test and the second test or using (d) The presence of halogen (e.g., less than 2 mg/dL on both the initial either initial test and the nitrite bleach, iodine, fluoride) is verified and confirmatory creatinine tests on two concentration is equal to or greater than using either a general oxidant separate aliquots (i.e., the same 200 mcg/mL but less than 500 mcg/mL colorimetric test (with an equal to or colorimetric test may be used to test for a different confirmatory test (e.g., great than 200 mcg/mL nitrite- both aliquots) and the specific gravity is multi-wavelength spectrophotometry, equivalent cutoff or an equal to or great less than or equal to 1.0010 or equal to ion chromatography, capillary than 50 mcg/mL chromium (VI)- or greater than 1.0200 on both the initial electrophoresis) on two separate equivalent cutoff) or halogen and confirmatory specific gravity tests aliquots; colorimetric test (halogen concentration on two separate aliquots (i.e., a (d) The possible presence of equal to or greater than the LOQ) for the refractometer is used to test both chromium (VI) is determined using the initial test on the first aliquot and a aliquots). same chromium (VI) colorimetric test different confirmatory test (e.g., multi- with a cutoff equal to or greater than 50 wavelength spectrophotometry, ion Section 3.8 What criteria are used to mcg/mL chromium (VI) for both the chromatography, inductively coupled report a urine specimen as dilute? initial (first) test and the second test on plasma-mass spectrometry) with a A dilute result may be reported only two separate aliquots; specific halogen concentration equal to in conjunction with the positive or (e) The possible presence of a halogen or greater than the LOQ of the negative drug test results for a (e.g., bleach, iodine, fluoride) is confirmatory test on the second aliquot; specimen. (e) The presence of glutaraldehyde is (a) An HHS-certified laboratory or an determined using the same halogen verified using either an aldehyde test HHS-certified IITF reports a primary (A) colorimetric test with a cutoff equal to (aldehyde present) or the characteristic specimen as dilute when the creatinine or greater than the LOQ for both the immunoassay response on one or more concentration is greater than 5 mg/dL initial (first) test and the second test on drug immunoassay tests for the initial but less than 20 mg/dL and the specific two separate aliquots or relying on the test on the first aliquot and a different gravity is equal to or greater than 1.002 odor of the specimen as the initial test; confirmatory test (e.g., GC/MS) for the but less than 1.003 on a single aliquot. (f) The possible presence of confirmatory test with the (b) In addition, an HHS-certified glutaraldehyde is determined by using glutaraldehyde concentration equal to or laboratory reports a primary (A) the same aldehyde test (aldehyde greater than the LOQ of the analysis on specimen as dilute when the creatinine present) or characteristic immunoassay the second aliquot; concentration is equal to or greater than response on one or more drug (f) The presence of pyridine 2 mg/dL but less than 20 mg/dL and the immunoassay tests for both the initial (pyridinium chlorochromate) is verified specific gravity is greater than 1.0010 (first) test and the second test on two using either a general oxidant but less than 1.0030. separate aliquots; colorimetric test (with an equal to or (g) The possible presence of an greater than 200 mcg/mL nitrite- Section 3.9 What criteria are used to oxidizing adulterant is determined by equivalent cutoff or an equal to or report an invalid result for a urine using the same general oxidant greater than 50 mcg/mL chromium (VI)- specimen? colorimetric test (with an equal to or equivalent cutoff) or a chromium (VI) An HHS-certified laboratory reports a greater than 200 mcg/mL nitrite- colorimetric test (chromium (VI) primary (A) specimen as an invalid equivalent cutoff, an equal to or greater concentration equal to or greater than 50 result when: than 50 mcg/mL chromium (VI)- mcg/mL) for the initial test on the first (a) Inconsistent creatinine equivalent cutoff, or a halogen aliquot and a different confirmatory test concentration and specific gravity concentration is equal to or greater than (e.g., GC/MS) for the confirmatory test results are obtained (i.e., the creatinine the LOQ) for both the initial (first) test with the pyridine concentration equal to concentration is less than 2 mg/dL on and the second test on two separate or greater than the LOQ of the analysis both the initial and confirmatory aliquots; on the second aliquot; creatinine tests and the specific gravity (h) The possible presence of a (g) The presence of a surfactant is is greater than 1.0010 but less than surfactant is determined by using the verified by using a surfactant 1.0200 on the initial and/or same surfactant colorimetric test with colorimetric test with an equal to or confirmatory specific gravity test, the an equal to greater than 100 mcg/mL greater than 100 mcg/mL specific gravity is less than or equal to dodecylbenzene sulfonate-equivalent dodecylbenzene sulfonate-equivalent 1.0010 on both the initial and cutoff for both the initial (first) test and

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the second test on two separate aliquots Section 4.3 What are the requirements Section 4.4 What are the requirements or a foam/shake test for the initial test; to be a collector? to be an observer for a direct observed (i) Interference occurs on the initial collection? (a) An individual may serve as a drug tests on two separate aliquots (i.e., collector if they fulfill the following (a) An individual may serve as an valid immunoassay or alternate conditions: observer for a direct observed collection technology initial drug test results (1) Is knowledgeable about the when the individual has satisfied the cannot be obtained); requirements: (j) Interference with the drug collection procedure described in these Guidelines; (1) Is knowledgeable about the direct confirmatory assay occurs on two observed collection procedure described (2) Is knowledgeable about any separate aliquots of the specimen and in Section 8.9 of these Guidelines; the laboratory is unable to identify the guidance provided by the federal (2) Is knowledgeable about any interfering substance; agency’s Drug-Free Workplace Program and additional information provided by guidance provided by the federal (k) The physical appearance of the agency’s Drug-Free Workplace Program specimen (e.g., viscosity) is such that the Secretary relating to these Guidelines; or additional information provided by testing the specimen may damage the the Secretary relating to the direct laboratory’s instruments; or (3) Is trained and qualified to collect observed collection procedure described (l) The specimen has been tested and a urine specimen. Training must in these Guidelines; include the following: the appearances of the primary (A) and (3) Has received training on the the split (B) specimens (e.g., color) are (i) All steps necessary to complete a following subjects: clearly different; or urine collection; (i) All steps necessary to perform a (m) The concentration of a biomarker (ii) Completion and distribution of the direct observed collection; and is not consistent with that established Federal CCF; (ii) The observer’s responsibility for for human urine for both the initial (iii) Problem collections; maintaining the integrity of the (first) test and the second test on two collection process, ensuring the privacy separate aliquots. (iv) Fatal flaws, correctable flaws, and how to correct problems in collections; of individuals being tested, ensuring Subpart D—Collectors and that the observation is done in a professional manner that minimizes the Section 4.1 Who may collect a (v) The collector’s responsibility for discomfort to the employee so observed, specimen? maintaining the integrity of the collection process, ensuring the privacy ensuring the security of the specimen by (a) A collector who has been trained of the donor, ensuring the security of maintaining visual contact with the to collect urine specimens in the specimen, and avoiding conduct or collection container until it is delivered accordance with these Guidelines. statements that could be viewed as to the collector, and avoiding conduct or (b) The immediate supervisor of a offensive or inappropriate. statements that could be viewed as offensive or inappropriate. federal employee donor may only (4) Has demonstrated proficiency in (b) The gender of the observer must be collect that donor’s specimen when no collections by completing five the same as the donor’s gender, which other collector is available. The consecutive error-free mock collections. supervisor must be a trained collector. is determined by the donor’s gender (i) The five mock collections must (c) The hiring official of a federal identity. The observer selection process include one uneventful collection agency applicant may only collect that is described in Section 8.10(b). scenario, one insufficient specimen federal agency applicant’s specimen (c) The observer is not required to be quantity scenario, one temperature out when no other collector is available. a trained collector. of range scenario, one scenario in which The hiring official must be a trained the donor refuses to sign the Federal Section 4.5 What are the requirements collector. CCF, and one scenario in which the to be a trainer for collectors? Section 4.2 Who may not collect a donor refuses to initial the specimen (a) Individuals are considered specimen? bottle tamper-evident seal. qualified trainers for collectors and may (a) A federal agency employee who is (ii) A qualified trainer for collectors train others to collect urine specimens in a testing designated position and must monitor and evaluate the when they have completed the subject to the federal agency drug individual being trained, in person or by following: testing rules must not be a collector for a means that provides real-time (1) Qualified as a trained collector and co-workers in the same testing pool or observation and interaction between the regularly conducted urine drug test who work together with that employee trainer and the trainee, and the trainer collections for a period of at least one on a daily basis. must attest in writing that the mock year or collections are error-free. (b) A federal agency applicant or (2) Completed a ‘‘train the trainer’’ employee must not collect their own (b) A trained collector must complete course given by an organization (e.g., drug testing specimen. refresher training at least every five manufacturer, private entity, contractor, (c) An employee working for an HHS- years that includes the requirements in federal agency). certified laboratory or IITF must not act paragraph (a) of this section. (b) A qualified trainer for collectors as a collector if the employee could link (c) The collector must maintain the must complete refresher training at least the identity of the donor to the donor’s documentation of their training and every five years in accordance with the drug test result. provide that documentation to a federal collector requirements in Section 4.3(a). (d) To avoid a potential conflict of agency when requested. (c) A qualified trainer for collectors interest, a collector must not be related (d) An individual may not collect must maintain the documentation of the to the employee (e.g., spouse, ex-spouse, specimens for a federal agency until the trainer’s training and provide that relative) or a close personal friend (e.g., individual’s training as a collector has documentation to a federal agency when fiance´e). been properly documented. requested.

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Section 4.6 What must a federal Section 5.4 How long must collection Section 6.2 What happens if the agency do before a collector is permitted site records be stored? correct OMB-approved Federal CCF is to collect a specimen? Collection site records (e.g., collector not available or is not used? A federal agency must ensure the copies of the OMB-approved Federal (a) The use of a non-federal CCF or an following: CCF) must be stored securely for a expired Federal CCF is not, by itself, a (a) The collector has satisfied the minimum of 2 years. The collection site reason for the HHS-certified laboratory requirements described in Section 4.3; may convert hardcopy records to or IITF to automatically reject the electronic records for storage and specimen for testing or for the MRO to (b) The collector, who may be self- discard the hardcopy records after 6 cancel the test. employed, or an organization (e.g., third months. party administrator that provides a (b) If the collector does not use the collection service, collector training Section 5.5 How does the collector correct OMB-approved Federal CCF, the company, federal agency that employs ensure the security and integrity of a collector must document that it is a its own collectors) maintains a copy of specimen at the collection site? federal agency specimen collection and the training record(s); and provide the reason that the incorrect (a) A collector must do the following form was used. Based on the (c) The collector has been provided to maintain the security and integrity of information provided by the collector, the name and telephone number of the a specimen: the HHS-certified laboratory or IITF federal agency representative. (1) Not allow unauthorized personnel must handle and test the specimen as a Subpart E—Collection Sites to enter the collection area during the federal agency specimen. collection procedure; (c) If the HHS-certified laboratory, Section 5.1 Where can a collection for (2) Perform only one donor collection HHS-certified IITF, or MRO discovers a drug test take place? at a time; that the collector used an incorrect (3) Restrict access to collection form, the laboratory, IITF, or MRO must (a) A collection site may be a supplies before, during and after obtain a memorandum for the record permanent or temporary facility located collection; from the collector describing the reason either at the work site or at a remote (4) Ensure that only the collector and the incorrect form was used. If a site. the donor are allowed to handle the memorandum for the record cannot be (b) In the event that an agency- unsealed specimen; designated collection site is not (5) Ensure the chain of custody obtained, the laboratory or IITF reports accessible and there is an immediate process is maintained and documented a rejected for testing result to the MRO requirement to collect a urine specimen throughout the entire collection, storage, and the MRO cancels the test. The HHS- (e.g., an accident investigation), a public and transport procedures; certified laboratory or IITF must wait at restroom may be used for the collection, (6) Ensure that the Federal CCF is least 5 business days while attempting using the procedures for a monitored completed and distributed as required; to obtain the memorandum before collection described in Section 8.12. and reporting a rejected for testing result to the MRO. Section 5.2 What are the requirements (7) Ensure that specimens transported for a collection site? to an HHS-certified laboratory or IITF Subpart G—Urine Specimen Collection are sealed and placed in transport Containers and Bottles The facility used as a collection site containers designed to minimize the must have the following: possibility of damage during shipment Section 7.1 What is used to collect a urine specimen? (a) Provisions to ensure donor privacy (e.g., specimen boxes, padded mailers, during the collection (as described in or other suitable shipping container), A single-use collection container with Section 8.1); and those containers are securely sealed a means (i.e., thermometer) to measure (b) A suitable and clean surface area to eliminate the possibility of urine temperature and two specimen that is not accessible to the donor for undetected tampering; bottles must be used. (b) Couriers, express carriers, and handling the specimens and completing Section 7.2 What are the requirements the required paperwork; postal service personnel are not required to document chain of custody for a urine collection container and (c) A secure temporary storage area to since specimens are sealed in packages specimen bottles? maintain specimens until the specimen that would indicate tampering during is transferred to an HHS-certified (a) The collection container, the transit to the HHS-certified laboratory or laboratory or IITF; thermometer, and the specimen bottles IITF. must not substantially affect the (d) A restricted access area where Section 5.6 What are the privacy composition of drugs and/or metabolites only authorized personnel may be in the urine specimen. present during the collection; requirements when collecting a urine specimen? (b) The two specimen bottles must be (e) A restricted access area for the sealable and non-leaking, and must storage of collection supplies; Collections must be performed at a maintain the integrity of the specimen (f) The ability to store records site that provides reasonable privacy (as during storage and transport so that the securely; and described in Section 8.1). specimen contained therein can be (g) The ability to restrict the donor Subpart F—Federal Drug Testing tested in an HHS-certified laboratory or access to potential diluents in Custody and Control Form IITF for the presence of drugs or their accordance with Section 8.2. metabolites. Section 6.1 What federal form is used (c) The two specimen bottles must be Section 5.3 Where must collection site to document custody and control? records be stored? sufficiently transparent to enable an The OMB-approved Federal CCF must objective assessment of specimen Collection site records must be stored be used to document custody and appearance and identification of at a secure site designated by the control of each specimen at the abnormal physical characteristics collector or the collector’s employer. collection site. without opening the bottle.

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Section 7.3 What are the minimum (a) Placing a toilet bluing agent in a items or substances that could be used performance requirements for a urine toilet bowl or toilet tank, so the to adulterate or substitute the urine collection container and specimen reservoir of water in the toilet bowl specimen: bottles? always remains blue. If no bluing agent (1) The collector must ensure that all (a) The collection container must be is available or if the toilet has an personal belongings (e.g., purse or capable of holding at least 55 mL and automatic flushing system, the collector briefcase) remain with the outer have a volume marking clearly noting a shall turn the water supply off to the garments; the donor may retain the level of 45 mL. toilet and flush the toilet to remove the donor’s wallet. (b) One of the two specimen bottles water in the toilet when possible. (2) The collector asks the donor to must be capable of holding at least 35 (b) Secure other sources of water (e.g., empty the donor’s pockets and display mL and the other at least 20 mL, and shower or sink) in the enclosure where the contents to ensure no items are each must have a volume marking urination occurs. If the enclosure has a present that could be used to adulterate clearly noting the appropriate level (30 source of water that cannot be disabled or substitute the specimen. (3) If no items are present that can be mL for the primary specimen and 15 mL or secured, a monitored collection must used to adulterate or substitute the for the split specimen). be conducted in accordance with specimen, the donor can place the items (c) The thermometer may be affixed to Section 8.11. back into the donor’s pockets and or built into the collection container and Section 8.3 What are the preliminary continue the collection procedure. must provide graduated temperature steps in the urine specimen collection (4) If an item is present that appears readings from 32–38 °C/90–100 °F. procedure? to have been brought to the collection Alternatively, the collector may use site with the intent to adulterate, another technology to measure The collector must take the following substitute, or dilute the specimen, this specimen temperature (e.g., thermal steps before beginning a urine specimen is considered a refusal to test. The radiation scanning), providing the collection: (a) If a donor fails to arrive at the collector must stop the collection and thermometer does not come into contact collection site at the assigned time, the report the refusal to test as described in with the specimen. collector must follow the federal agency Section 8.13. If the item appears to be Subpart H—Urine Specimen Collection policy or contact the federal agency inadvertently brought to the collection Procedure representative to obtain guidance on site, the collector must secure the item action to be taken. and continue the normal collection Section 8.1 What privacy must the (b) When the donor arrives at the procedure. donor be given when providing a urine collection site, the collector should (5) If the donor refuses to show the specimen? begin the collection procedure without collector the items in the donor’s The following privacy requirements undue delay. For example, the pockets, this is considered a refusal to apply when a donor is providing a urine collection should not be delayed test. The collector must stop the specimen: because the donor states that they are collection and report the refusal to test (a) Only authorized personnel and the unable to urinate or an authorized as described in Section 8.13. donor may be present in the restricted employer or employer representative is (i) The collector shall instruct the access area where the collection takes late in arriving. donor to wash and dry the donor’s place. (c) The collector requests the donor to hands prior to urination. After washing (b) The collector is not required to be present photo identification (e.g., the donor’s hands, the donor must the same gender as the donor. The driver’s license; employee badge issued remain in the presence of the collector gender of the observer for purposes of a by the employer; an alternative photo and must not have access to any water direct observed collection (i.e., as identification issued by a federal, state, fountain, faucet, soap dispenser, described in Section 8.10) must be the or local government agency). If the cleaning agent, or any other materials same as the donor’s gender, which is donor does not have proper photo which could be used to adulterate or determined by the donor’s gender identification, the collector shall contact substitute the specimen. identity. The gender of the monitor for the supervisor of the donor or the (1) If the donor refuses to wash the a monitored collection (i.e., as described federal agency representative who can donor’s hands when instructed by the in Section 8.12) must be the same as the positively identify the donor. If the collector, this is considered a ‘‘refusal to donor’s gender, unless the monitor is a donor’s identity cannot be established, test.’’ The collector must stop the medical professional (e.g., nurse, doctor, the collector must not proceed with the collection and report the refusal to test physician’s assistant, technologist, or collection. as described in Section 8.13. technician licensed or certified to (d) The collector must provide Section 8.4 What steps does the practice in the jurisdiction in which the identification (e.g., employee badge, collector take in the collection collection takes place). employee list) if requested by the donor. procedure before the donor provides a (c) The collector must give the donor (e) The collector explains the basic urine specimen? visual privacy while providing the collection procedure to the donor. specimen. The donor is allowed to (f) The collector informs the donor (a) The collector will provide or the provide a urine specimen in an enclosed that the instructions for completing the donor may select a specimen collection stall within a multi-stall restroom or in Federal Custody and Control Form are container that is clean, unused, a single person restroom during a located on the back of the Federal CCF wrapped/sealed in original packaging monitored collection. or available upon request. and compliant with Subpart G. The (g) The collector answers any specimen collection container will be Section 8.2 What must the collector reasonable and appropriate questions opened in view of the donor. ensure at the collection site before the donor may have regarding the (b) The collector instructs the donor starting a urine specimen collection? collection procedure. to provide the specimen in the privacy The collector must deter the dilution (h) The collector asks the donor to of a stall or otherwise partitioned area or substitution of a specimen at the remove any unnecessary outer garments that allows for individual privacy. The collection site by: (e.g., coat, jacket) that might conceal collector directs the donor to provide a

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specimen of at least 45 mL, to not flush observation in accordance with Section Federal CCF to the MRO and to the the toilet, and to return with the 8.9. The collector must forward both federal agency’s designated specimen as soon as the donor has specimens (i.e., from the first and representative. The federal agency may completed the void. second collections) to an HHS-certified choose to provide the collection site (1) Except in the case of a direct laboratory for testing and record a with a standard protocol to follow in observed collection (i.e., as described in comment on the Federal CCF for each lieu of requiring the collector to notify Section 8.10) or a monitored collection specimen. the agency’s designated representative (i.e., as described in Section 8.12), (e) The collector must inspect the for authorization in each case. If an neither the collector nor anyone else specimen to determine if there is any alternate specimen is authorized, the may go into the room with the donor. sign indicating that the specimen may collector may begin the collection (2) The collector may set a reasonable not be a valid urine specimen (e.g., procedure for the alternate specimen time limit for specimen collection. unusual color, presence of foreign (see Section 8.7) in accordance with the (c) The collector notes any unusual objects or material, unusual odor). Mandatory Guidelines for Federal behavior or appearance of the donor on (1) The collector notes any unusual Workplace Drug Testing Programs using the Federal CCF. If the collector detects finding on the Federal CCF. A specimen the alternative specimen. any conduct that clearly indicates an suspected of not being a valid urine (g) If the donor fails to remain present attempt to tamper with a specimen (e.g., specimen must be forwarded to an HHS- through the completion of the substitute urine in plain view or an certified laboratory for testing. collection, declines to have a direct attempt to bring into the collection site (2) When there is any reason to observed collection as required in steps an adulterant or urine substitute), the believe that a donor may have (d)(2) or (e)(2) above, refuses to provide collector must report a refusal to test in adulterated or substituted the specimen, a second specimen as required in step accordance with Section 8.13. another specimen must be obtained as (f)(2) above, or refuses to provide an soon as possible under direct alternate specimen as authorized in step Section 8.5 What steps does the observation in accordance with Section (f)(2)(iii) above, the collector stops the collector take during and after the urine 8.10. The collector must forward both collection and reports the refusal to test specimen collection procedure? specimens (i.e., from the first and in accordance with Section 8.13. Integrity and Identity of the second collections) to an HHS-certified Section 8.6 What procedure is used Specimen. The collector must take the laboratory for testing and record a when the donor states that they are following steps during and after the comment on the Federal CCF for each unable to provide a urine specimen? donor provides the urine specimen: specimen. (a) The collector must inform the (f) The collector must determine the (a) If the donor states that they are donor that, once the collection volume of urine in the specimen unable to provide a urine specimen procedure has begun, the donor must container. The collector must never during the collection process, the remain at the collection site (i.e., in an combine urine collected from separate collector requests that the donor enter area designated by the collector) until voids to create a specimen. the restroom (stall) and attempt to the collection is complete. This includes (1) If the volume is at least 45 mL, the provide a urine specimen. the wait period (i.e., up to 3 hours) if collector will proceed with steps (b) The donor demonstrates their needed to provide a sufficient specimen described in Section 8.8. inability to provide a specimen when he as described in step (f)(2) below and in (2) If the volume is less than 45 mL, or she comes out of the stall with an Section 8.6. the collector discards the specimen and empty collection container. (b) After providing the specimen, the immediately collects a second specimen (1) If the donor states that they could donor gives the specimen collection using the same procedures as for the provide a specimen after drinking some container to the collector. Both the first specimen (including steps in fluids, the collector gives the donor a donor and the collector must keep the paragraphs c and d of this section). reasonable amount of liquid to drink for specimen container in view at all times (i) The collector may give the donor this purpose (e.g., an 8 ounce glass of until the collector seals the specimen a reasonable amount of liquid to drink water every 30 minutes, but not to bottles as described in Section 8.8. for this purpose (e.g., an 8 ounce glass exceed a maximum of 40 ounces over a (c) After the donor has given the of water every 30 minutes, but not to period of 3 hours or until the donor has specimen to the collector, whenever exceed a maximum of 40 ounces over a provided a sufficient urine specimen). If practical, the donor shall be allowed to period of 3 hours or until the donor has the donor simply needs more time wash the donor’s hands and the donor provided a sufficient urine specimen). before attempting to provide a urine may flush the toilet. However, the donor is not required to specimen, the donor is not required to (d) The collector must measure the drink any fluids during this waiting drink any fluids during the 3 hour wait temperature of the specimen within 4 time. time. minutes of receiving the specimen from (ii) If the donor provides a sufficient (2) If the donor states that they are the donor. The collector records on the urine specimen (i.e., at least 45 mL), the unable to provide a urine specimen, the Federal CCF whether or not the collector proceeds with steps described collector records the reason for not temperature is in the acceptable range of in Section 8.8. collecting a urine specimen on the 32 °–38 °C/90 °–100 °F. (iii) If the employee has not provided Federal CCF, notifies the federal (1) The temperature measuring device a sufficient specimen (i.e., at least 45 agency’s designated representative for must accurately reflect the temperature mL) within three hours of the first authorization of an alternate specimen of the specimen and not contaminate unsuccessful attempt to provide the to be collected, and sends the the specimen. specimen, the collector records the appropriate copies of the Federal CCF to (2) If the temperature of the specimen reason for not collecting a urine the MRO and to the federal agency’s is outside the range of 32 °–38 °C/90 °– specimen on the Federal CCF, notifies designated representative. The federal 100 °F, that is a reason to believe that the federal agency’s designated agency may choose to provide the the donor may have adulterated or representative for authorization of an collection site with a standard protocol substituted the specimen. Another alternate specimen to be collected, and to follow in lieu of requiring the specimen must be collected under direct sends the appropriate copies of the collector to notify the agency’s

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designated representative for under proper specimen storage gender, which is determined by the authorization in each case. If an conditions until transported. donor’s gender identity, with no alternate specimen is authorized, the (j) The collector must discard any exception to this requirement. collector may begin the collection urine left over in the collection (b) Before an observer is selected, the procedure for the alternate specimen container after both specimen bottles collector informs the donor that the (see Section 8.7) in accordance with the have been appropriately filled and gender of the observer will match the Mandatory Guidelines for Federal sealed. There is one exception to this donor’s gender, which is determined by Workplace Drug Testing Programs using requirement: The collector may use the donor’s gender identity (as defined the alternative specimen. excess urine to conduct clinical tests in Section 1.5). The collector then (e.g., protein, glucose) if the collection Section 8.7 If the donor is unable to selects the observer to conduct the was conducted in conjunction with a observation: provide a urine specimen, may another physical examination required by specimen type be collected for testing? (i) The collector asks the donor to federal agency regulation. Neither the identify the donor’s gender on the Yes, if the alternate specimen type is collector nor anyone else may conduct Federal CCF and initial it. authorized by Mandatory Guidelines for further testing (such as specimen (ii) The donor will then be provided Federal Workplace Drug Testing validity testing) on the excess urine. an observer whose gender matches the Programs and specifically authorized by donor’s gender. the federal agency. Section 8.9 When is a direct observed collection conducted? (iii) The collector documents the Section 8.8 How does the collector A direct observed collection observer’s name and gender on the prepare the urine specimens? procedure must be conducted when: Federal CCF. (a) All federal agency collections are (a) The agency has authorized a direct (c) If there is no collector available of to be split specimen collections. observed collection because: the same gender as the donor’s gender, (b) The collector, in the presence of (1) The donor’s previous drug test the collector or collection site the donor, pours the urine from the result was reported by an MRO as supervisor shall select an observer collection container into two specimen positive, adulterated, or substituted; or trained in direct observed specimen bottles to be labeled ‘‘A’’ and ‘‘B’’. The (2) The HHS-certified laboratory collection as described in Section 4.4. collector pours at least 30 mL of urine reports to the MRO that a specimen is The observer may be an individual that into Bottle A and at least 15 mL into invalid, and the MRO reported to the is not a trained collector. Bottle B, and caps each bottle. agency that there was not a legitimate (d) At the point in a routine collection (c) In the presence of the donor, the medical explanation for the result; or where the donor enters the restroom collector places a tamper-evident label/ (3) The MRO reported to the agency with the collection container, a direct seal from the Federal CCF over each that the primary bottle (A) specimen observed collection includes the specimen bottle cap. The collector was positive, adulterated, or substituted following additional steps: records the date of the collection on the result had to be cancelled because the (1) The observer enters the restroom tamper-evident labels/seals. test of the split specimen could not be with the donor; (d) The collector instructs the donor tested and/or the split specimen bottle (2) The observer must directly watch to initial the tamper-evident labels/seals (B) failed to reconfirm; or the urine go from the donor’s body into on each specimen bottle. If the donor (b) At the collection site, an the collection container (the use of refuses to initial the labels/seals, the immediate collection of a second urine mirrors or video cameras is not collector notes the refusal on the specimen is required because: permitted); Federal CCF and continues with the (1) The temperature of the specimen (3) The observer must not touch or collection process. collected during a routine collection is handle the collection container unless (e) The collector must ensure that all outside the acceptable temperature the observer is also serving as the the information required on the Federal range; or collector; CCF is provided. (2) The collector suspects that the (4) After the donor has completed (f) The collector asks the donor to donor has tampered with the specimen urinating into the collection container: read and sign a statement on the Federal during a routine collection (e.g., (i) If the same person serves as the CCF certifying that the specimens abnormal physical characteristic such as observer and collector, that person may identified were collected from the unusual color and/or odor, and/or receive the collection container from the donor. If the donor refuses to sign the excessive foaming when shaken). certification statement, the collector (c) The collector must contact a donor while they are both in the notes the refusal on the Federal CCF and collection site supervisor to review and restroom; continues with the collection process. concur in advance with any decision by (ii) If the observer is not serving as the (g) The collector signs and prints their the collector to obtain a specimen under collector, the donor and observer leave name on the Federal CCF, completes the direct observation. the restroom and the donor hands the Federal CCF, and distributes the copies (d) If the donor declines to have a collection container directly to the of the Federal CCF as required. direct observed collection, the collector collector. The observer must maintain (h) The collector seals the specimens reports a refusal to test (i.e., as described visual contact of the collection (Bottle A and Bottle B) in a package and, in Section 8.13). container until the donor hands the within 24 hours or during the next container to the collector. business day, sends them to the HHS- Section 8.10 How is a direct observed (5) The collector checks the box for an certified laboratory or IITF that will be collection conducted? observed collection on the Federal CCF testing the Bottle A urine specimen. (a) A direct observed collection and writes the name of the observer and (i) If the specimen and Federal CCF procedure is the same as that for a the reason for an observed collection on are not immediately transported to an routine collection, except an observer the Federal CCF; and HHS-certified laboratory or IITF, they watches the donor urinate into the (6) The collector then continues with must remain under direct control of the collection container. The observer’s the routine collection procedure in collector or be appropriately secured gender must be the same as the donor’s Section 8.3.

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Section 8.11 When is a monitored receive the collection container from the Subpart I—HHS Certification of collection conducted? donor while they are both in the Laboratories and IITFs restroom; (a) In the event that an agency- Section 9.1 Who has the authority to designated collection site is not (2) If the monitor is not serving as the certify laboratories and IITFs to test available and there is an immediate collector, the donor and monitor leave urine specimens for federal agencies? requirement to collect a specimen (e.g., the restroom and the donor hands the an accident investigation), a public collection container directly to the (a) The Secretary has broad discretion restroom may be used for the collection, collector. The monitor must ensure that to take appropriate action to ensure the using the procedures for a monitored the employee takes the collection full reliability and accuracy of drug collection described in Section 8.12. container directly to the collector as testing and reporting, to resolve (b) If the enclosure used by the donor soon as the employee has exited the problems related to drug testing, and to to provide a specimen has a source of enclosure. enforce all standards set forth in these water that cannot be disabled or Guidelines. The Secretary has the (f) If the monitor is not serving as the secured, a monitored collection must be authority to issue directives to any HHS- conducted. collector, the collector writes the name certified laboratory or IITF including (c) If the donor declines to permit a of the monitor on the Federal CCF. suspending the use of certain analytical collection to be monitored when (g) The collector then continues with procedures when necessary to protect required, the collector reports a refusal the routine collection procedure in the integrity of the testing process; to test (i.e., as described in Section Section 8.3. ordering any HHS-certified laboratory or 8.13). IITF to undertake corrective actions to Section 8.13 How does the collector respond to material deficiencies Section 8.12 How is a monitored report a donor’s refusal to test? identified by an inspection or through collection conducted? If there is a refusal to test as defined performance testing; ordering any HHS- A monitored collection is the same as in Section 1.7, the collector stops the certified laboratory or IITF to send that for a routine collection, except that collection, discards any urine collected specimens or specimen aliquots to a monitor accompanies the donor into and reports the refusal to test by: another HHS-certified laboratory for the restroom to check for signs that the retesting when necessary to ensure the donor may be tampering with the (a) Notifying the federal agency by accuracy of testing under these specimen. The monitor remains in the means (e.g., telephone, email, or secure Guidelines; ordering the review of restroom, but outside the stall, while the fax) that ensures that the notification is results for specimens tested under the donor is providing the specimen. A immediately received, Guidelines for private sector clients to person of the same gender as the donor (b) Documenting the refusal to test on the extent necessary to ensure the full shall serve as the monitor, unless the the Federal CCF, and reliability of drug testing for federal monitor is a medical professional (e.g., (c) Sending all copies of the Federal agencies; and ordering any other action nurse, doctor, physician’s assistant, necessary to address deficiencies in technologist, or technician licensed or CCF to the federal agency’s designated representative. drug testing, analysis, specimen certified to practice in the jurisdiction collection, chain of custody, reporting of in which the collection takes place). The Section 8.14 What are a federal results, or any other aspect of the same procedures used for selecting an agency’s responsibilities for a collection certification program. observer of the appropriate gender in site? (b) A laboratory or IITF is prohibited Section 8.10(b) must be used to select from stating or implying that it is the monitor for the purposes of Section (a) A federal agency must ensure that certified by HHS under these Guidelines 8.12, unless the monitor is a medical collectors and collection sites satisfy all to test urine specimens for federal professional as described above. The requirements in subparts D, E, F, G, and agencies unless it holds such monitor may be an individual other H. certification. than the collector and need not be a (b) A federal agency (or only one qualified collector. federal agency when several agencies Section 9.2 What is the process for a (a) The collector secures the restroom are using the same collection site) must laboratory or IITF to become HHS- being used for the monitored collection inspect 5 percent or up to a maximum certified? so that no one except the employee and of 50 collection sites each year, selected (a) A laboratory or IITF seeking HHS the monitor can enter the restroom until randomly from those sites used to certification must: after the collection has been completed. collect agency specimens (e.g., virtual, (1) Submit a completed OMB- (b) The monitor enters the restroom onsite, or self-evaluation). approved application form (i.e., the with the donor. (c) The monitor must not watch the (c) A federal agency must investigate applicant laboratory or IITF provides employee urinate into the collection reported collection site deficiencies detailed information on both the container. If the monitor hears sounds (e.g., specimens reported ‘‘rejected for administrative and analytical or makes other observations indicating testing’’ by an HHS-certified laboratory procedures to be used for federally an attempt by the donor to tamper with or IITF) and take appropriate action regulated specimens); a specimen, there must be an additional which may include a collection site self- (2) Have its application reviewed as collection under direct observation in assessment (i.e., using the Collection complete and accepted by HHS; accordance with Section 8.9. Site Checklist for the Collection of Urine (3) Successfully complete the PT (d) The monitor must not touch or Specimens for Federal Agency challenges in 3 consecutive sets of handle the collection container unless Workplace Drug Testing Programs) or an initial PT samples; the monitor is also the collector. inspection of the collection site. The (4) Satisfy all the requirements for an (e) After the donor has completed inspections of these additional initial inspection; and urinating into the collection container: collection sites may be included in the (5) Receive notification of certification (1) If the same person serves as the 5 percent or maximum of 50 collection from the Secretary before testing monitor and collector, that person may sites inspected annually. specimens for federal agencies.

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Section 9.3 What is the process for a of the confirmatory test cutoff that differs by more than ±50 percent laboratory or IITF to maintain HHS concentration when the PT sample is from the appropriate reference or peer certification? designated as a retest sample; or group mean; (a) To maintain HHS certification, a (iii) The concentration of drug or (6) For each confirmatory drug test, laboratory or IITF must: metabolite may differ from 9.5(a)(1)(i) correctly identify and determine the (1) Successfully participate in both and 9.5(a)(1)(ii) for a special purpose. concentrations [i.e., no more than ±20 the maintenance PT and inspection (2) A PT sample may contain an percent or ±2 standard deviations programs (i.e., successfully test the interfering substance, an adulterant, or (whichever is larger) from the required quarterly sets of maintenance satisfy the criteria for a substituted appropriate reference or peer group PT samples, undergo an inspection 3 specimen, dilute specimen, or invalid means] for at least 50 percent of the months after being certified, and result. drug challenges for an individual drug undergo maintenance inspections at a (3) A negative PT sample will not over the three sets of PT samples; minimum of every 6 months thereafter); contain a measurable amount of a target (7) Correctly identify at least 80 (2) Respond in an appropriate, timely, analyte. percent of the total specimen validity and complete manner to required (b) PT samples used to evaluate testing challenges over the three sets of corrective action requests if deficiencies specimen validity tests shall satisfy, but PT samples; are not limited to, one of the following are identified in the maintenance PT (8) Correctly identify at least 80 performance, during the inspections, criteria: (1) The nitrite concentration will be at percent of the challenges for each operations, or reporting; and individual specimen validity test over (3) Satisfactorily complete corrective least 20 percent above the cutoff; (2) The pH will be between 1.5 and the three sets of PT samples; remedial actions, and undergo special (9) For quantitative specimen validity inspection and special PT sets to 5.0 or between 8.5 and 12.5; (3) The concentration of an oxidant tests, obtain quantitative values for at maintain or restore certification when least 80 percent of the total challenges material deficiencies occur in either the will be at a level sufficient to challenge a laboratory’s ability to identify and over the three sets of PT samples that PT program, inspection program, or in satisfy the following criteria: operations and reporting. confirm the oxidant; (4) The creatinine concentration will (i) Nitrite and creatinine Section 9.4 What is the process when be between 0 and 20 mg/dL; or concentrations are no more than ±20 a laboratory or IITF does not maintain (5) The specific gravity will be less percent or ±2 standard deviations from its HHS certification? than or equal to 1.0050 or between the appropriate reference or peer group (a) A laboratory or IITF that does not 1.0170 and 1.0230. mean; and maintain its HHS certification must: (c) For each PT cycle, the set of PT (ii) pH values are no more than ±0.3 (1) Stop testing federally regulated samples going to each HHS-certified pH units from the appropriate reference specimens; laboratory or IITF will vary but, within or peer group mean using a pH meter; (2) Ensure the security of federally each calendar year, each HHS-certified and regulated specimens and records laboratory or IITF will analyze (iii) Specific gravity values are no throughout the required storage period essentially the same total set of samples. more than ±0.0003 specific gravity units described in Sections 11.20, 11.21, (d) The laboratory or IITF must (to the from the appropriate reference or peer 12.18, and 14.8; greatest extent possible) handle, test, group mean when the mean is less than (3) Ensure access to federally and report a PT sample in a manner 1.0100 and specific gravity values are no regulated specimens and records in identical to that used for a donor more than ±0.0004 specific gravity units accordance with Sections 11.23, 11.24, specimen, unless otherwise specified. from the appropriate reference or peer 12.20, 12.21, and Subpart P; and Section 9.6 What are the PT group mean when the mean is equal to (4) Follow the HHS suspension and requirements for an applicant or greater than 1.0100; revocation procedures when imposed by laboratory? (10) Must not obtain any quantitative the Secretary, follow the HHS value on a specimen validity test PT procedures in Subpart P that will be (a) An applicant laboratory that seeks certification under these Guidelines sample that differs from the appropriate used for all actions associated with the reference or peer group mean by more suspension and/or revocation of HHS- must satisfy the following criteria on ± three consecutive sets of PT samples: than 50 percent for nitrite and certification. creatinine concentrations, ±0.8 pH units (1) Have no false positive results; ± Section 9.5 What are the qualitative (2) Correctly identify, confirm, and using a pH meter, 0.0006 specific and quantitative specifications of gravity units when the mean is less than report at least 90 percent of the total ± performance testing (PT) samples? drug challenges over the three sets of PT 1.0100, or 0.0007 specific gravity units when the mean is equal to or greater (a) PT samples used to evaluate drug samples; than 1.0100; and tests will be prepared using the (3) Correctly identify at least 80 following specifications: percent of the drug challenges for each (11) Must not report any sample as (1) PT samples may contain one or initial drug test over the three sets of PT adulterated with a compound that is not more of the drugs and drug metabolites samples; present in the sample, adulterated based in the drug classes listed in Section 3.4 (4) For the confirmatory drug tests, on pH when the appropriate reference and must satisfy one of the following correctly determine the concentrations or peer group mean is within the parameters: [i.e., no more than ±20 percent or ±2 acceptable pH range, or substituted (i) The concentration of a drug or standard deviations (whichever is when the appropriate reference or peer metabolite will be at least 20 percent larger) from the appropriate reference or group means for both creatinine and above the initial test cutoff peer group means] for at least 80 percent specific gravity are within the concentration for the drug or drug of the total drug challenges over the acceptable range. metabolite; three sets of PT samples; (b) Failure to satisfy these (ii) The concentration of a drug or (5) For the confirmatory drug tests, requirements will result in metabolite may be as low as 40 percent must not obtain any drug concentration disqualification.

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Section 9.7 What are the PT (10) Obtain no more than one concentration, or ±0.002 specific gravity requirements for an HHS-certified urine quantitative value over 2 consecutive PT units for specific gravity. laboratory? cycles on a specimen validity test PT (b) Failure to satisfy these (a) A laboratory certified under these sample that differs from the appropriate requirements will result in Guidelines must satisfy the following reference or peer group mean by more disqualification. ± criteria on the maintenance PT samples: than 50 percent for nitrite and (1) Have no false positive results; creatinine concentrations, ±0.8 pH units Section 9.9 What are the PT (2) Correctly identify, confirm, and using a pH meter, ±0.0006 specific requirements for an HHS-certified IITF? report at least 90 percent of the total gravity units when the mean is less than ± (a) An IITF certified under these drug challenges over two consecutive 1.0100, or 0.0007 specific gravity units Guidelines must satisfy the following PT cycles; when the mean is equal to or greater criteria on the maintenance PT samples (3) Correctly identify at least 80 than 1.0100; and to maintain its certification: percent of the drug challenges for each (11) Do not report any PT sample as initial drug test over two consecutive PT adulterated with a compound that is not (1) Correctly identify at least 90 cycles; present in the sample, adulterated based percent of the total drug challenges over (4) For the confirmatory drug tests, on pH when the appropriate reference two consecutive PT cycles; correctly determine that the or peer group mean is within the (2) Correctly identify at least 80 concentrations for at least 80 percent of acceptable pH range, or substituted percent of the drug challenges for each the total drug challenges are no more when the appropriate reference or peer individual drug test over two than ±20 percent or ±2 standard group means for both creatinine and consecutive PT cycles; deviations (whichever is larger) from the specific gravity are within the (3) Correctly identify at least 80 appropriate reference or peer group acceptable range. percent of the total specimen validity means over two consecutive PT cycles; (b) Failure to participate in all PT test challenges over two consecutive PT (5) For the confirmatory drug tests, cycles or to satisfy these requirements cycles; obtain no more than one drug may result in suspension or revocation concentration on a PT sample that of an HHS-certified laboratory’s (4) Correctly identify at least 80 differs by more than ±50 percent from certification. percent of the challenges for each the appropriate reference or peer group individual specimen validity test over mean over two consecutive PT cycles; Section 9.8 What are the PT two consecutive PT cycles; (6) For each confirmatory drug test, requirements for an applicant IITF? (5) For quantitative specimen validity correctly identify and determine that the (a) An applicant IITF that seeks tests, obtain quantitative values for at concentrations for at least 50 percent of certification under these Guidelines least 80 percent of the total specimen the drug challenges for an individual must satisfy the following criteria on validity test challenges over two drug are no more than ±20 percent or ±2 three consecutive sets of PT samples: consecutive PT cycles that satisfy the standard deviations (whichever is (1) Correctly identify at least 90 following criteria: larger) from the appropriate reference or percent of the total drug challenges over (i) Creatinine concentrations are no peer group means over two consecutive the three sets of PT samples; more than ±20 percent or ±2 standard PT cycles; (2) Correctly identify at least 80 deviations (whichever is larger) from the (7) Correctly identify at least 80 percent of the drug challenges for each appropriate reference or peer group percent of the total specimen validity individual drug test over the three sets mean; and testing challenges over two consecutive of PT samples; (3) Correctly identify at least 80 (ii) Specific gravity values are no PT cycles; ± (8) Correctly identify at least 80 percent of the total specimen validity more than 0.001 specific gravity units percent of the challenges for each test challenges over the three sets of PT from the appropriate reference or peer individual specimen validity test over samples; group mean; and two consecutive PT cycles; (4) Correctly identify at least 80 (6) Obtain no more than one (9) For quantitative specimen validity percent of the challenges for each quantitative value over 2 consecutive PT tests, obtain quantitative values for at individual specimen validity test over cycles on a specimen validity test PT least 80 percent of the total challenges the three sets of PT samples; sample that differs from the appropriate over two consecutive PT cycles that (5) For quantitative specimen validity reference or peer group mean by more satisfy the following criteria: tests, obtain quantitative values for at than ±50 percent for creatinine (i) Nitrite and creatinine least 80 percent of the total specimen concentration, or ±0.002 specific gravity concentrations are no more than ±20 validity test challenges over the three units for specific gravity. ± percent or 2 standard deviations from sets of PT samples that satisfy the (b) Failure to participate in all PT the appropriate reference or peer group following criteria: cycles or to satisfy these requirements (i) Creatinine concentrations are no mean; may result in suspension or revocation (ii) pH values are no more than ±0.3 more than ±20 percent or ±2 standard of an HHS-certified IITF’s certification. pH units from the appropriate reference deviations (whichever is larger) from the or peer group mean using a pH meter; appropriate reference or peer group Section 9.10 What are the inspection and mean; and requirements for an applicant (iii) Specific gravity values are no (ii) Specific gravity values are no laboratory or IITF? more than ±0.0003 specific gravity units more than ±0.001 specific gravity units from the appropriate reference or peer from the appropriate reference or peer (a) An applicant laboratory or IITF is group mean when the mean is less than group mean; and inspected by a team of two inspectors. 1.0100 and specific gravity values are no (6) Must not obtain any quantitative (b) Each inspector conducts an more than ±0.0004 specific gravity units value on a specimen validity test PT independent review and evaluation of from the appropriate reference or peer sample that differs from the appropriate all aspects of the laboratory’s or IITF’s group mean when the mean is equal to reference or peer group mean by more testing procedures and facilities using or greater than 1.0100; than ±50 percent for creatinine an inspection checklist.

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Section 9.11 What are the Section 9.14 What happens if an HHS- operation of the HHS-certified maintenance inspection requirements certified laboratory or IITF does not laboratory or IITF; or for an HHS-certified laboratory or IITF? satisfy the minimum requirements for (5) Any other cause that materially either the PT program or the inspection affects the ability of the HHS-certified (a) An HHS-certified laboratory or program? laboratory or IITF to ensure fully IITF must undergo an inspection 3 reliable and accurate drug test results (a) If an HHS-certified laboratory or months after becoming certified and at and reports. IITF fails to satisfy the minimum least every 6 months thereafter. (c) The period and terms of revocation requirements for certification, the shall be determined by the Secretary (b) An HHS-certified laboratory or laboratory or IITF is given a period of and shall depend upon the facts and IITF is inspected by one or more time (e.g., 5 or 30 working days circumstances of the revocation and the inspectors. The number of inspectors is depending on the nature of the need to ensure accurate and reliable determined according to the number of deficiency) to provide any explanation drug testing. specimens reviewed. Additional for its performance and evidence that all information regarding inspections is deficiencies have been corrected. Section 9.16 What factors are available from SAMHSA. (b) A laboratory’s or IITF’s HHS considered in determining whether to (c) Each inspector conducts an certification may be revoked, suspend a laboratory’s or IITF’s HHS independent evaluation and review of suspended, or no further action taken certification? the HHS-certified laboratory’s or IITF’s depending on the seriousness of the (a) The Secretary may immediately procedures, records, and facilities using deficiencies and whether there is suspend (either partially or fully) a guidance provided by the Secretary. evidence that the deficiencies have been laboratory’s or IITF’s HHS certification corrected and that current performance (d) To remain certified, an HHS- to conduct drug testing for federal meets the requirements for certification. agencies if the Secretary has reason to certified laboratory or IITF must (c) An HHS-certified laboratory or continue to satisfy the minimum believe that revocation may be required IITF may be required to undergo a and that immediate action is necessary requirements as stated in these special inspection or to test additional Guidelines. to protect the interests of the United PT samples to address deficiencies. States and its employees. Section 9.12 Who can inspect an HHS- (d) If an HHS-certified laboratory’s or (b) The Secretary shall determine the certified laboratory or IITF and when IITF’s certification is revoked or period and terms of suspension based may the inspection be conducted? suspended in accordance with the upon the facts and circumstances of the process described in Subpart P, the suspension and the need to ensure (a) An individual may be selected as laboratory or IITF is not permitted to accurate and reliable drug testing. an inspector for the Secretary if they test federally regulated specimens until satisfy the following criteria: the suspension is lifted or the laboratory Section 9.17 How does the Secretary or IITF has successfully completed the notify an HHS-certified laboratory or (1) Has experience and an educational certification requirements as a new IITF that action is being taken against background similar to that required for applicant laboratory or IITF. the laboratory or IITF? either a responsible person or a certifying scientist for an HHS-certified Section 9.15 What factors are (a) When laboratory’s or IITF’s HHS laboratory as described in Subpart K or considered in determining whether certification is suspended or the Secretary seeks to revoke HHS as a responsible technician for an HHS- revocation of a laboratory’s or IITF’s certification, the Secretary shall certified IITF as described in Subpart L; HHS certification is necessary? immediately serve the HHS-certified (2) Has read and thoroughly (a) The Secretary shall revoke laboratory or IITF with written notice of understands the policies and certification of an HHS-certified the suspension or proposed revocation requirements contained in these laboratory or IITF in accordance with by facsimile, mail, personal service, or Guidelines and in other guidance these Guidelines if the Secretary registered or certified mail, return consistent with these Guidelines determines that revocation is necessary receipt requested. This notice shall state provided by the Secretary; to ensure fully reliable and accurate the following: drug and specimen validity test results (3) Submits a resume and (1) The reasons for the suspension or and reports. documentation of qualifications to HHS; proposed revocation; (b) The Secretary shall consider the (2) The terms of the suspension or (4) Attends approved training; and following factors in determining proposed revocation; and (5) Performs acceptably as an whether revocation is necessary: (3) The period of suspension or inspector on an inspection of an HHS- (1) Unsatisfactory performance in proposed revocation. certified laboratory or IITF. analyzing and reporting the results of (b) The written notice shall state that drug and specimen validity tests (e.g., the laboratory or IITF will be afforded (b) The Secretary or a federal agency an HHS-certified laboratory reporting a an opportunity for an informal review of may conduct an inspection at any time. false positive result for an employee’s the suspension or proposed revocation Section 9.13 What happens if an drug test); if it so requests in writing within 30 applicant laboratory or IITF does not (2) Unsatisfactory participation in days of the date the laboratory or IITF satisfy the minimum requirements for performance testing or inspections; received the notice, or if expedited either the PT program or the inspection (3) A material violation of a review is requested, within 3 days of the program? certification standard, contract term, or date the laboratory or IITF received the other condition imposed on the HHS- notice. Subpart P contains detailed If an applicant laboratory or IITF fails certified laboratory or IITF by a federal procedures to be followed for an to satisfy the requirements established agency using the laboratory’s or IITF’s informal review of the suspension or for the initial certification process, the services; proposed revocation. laboratory or IITF must start the (4) Conviction for any criminal (c) A suspension must be effective certification process from the beginning. offense committed as an incident to immediately. A proposed revocation

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must be effective 30 days after written with its donor specimens based on the seal. The collector must indicate that notice is given or, if review is requested, projected total number of donor the specimen is a blind sample on the upon the reviewing official’s decision to specimens collected per year (up to a MRO copy where a donor would uphold the proposed revocation. If the maximum of 400 blind samples). Every normally provide a signature. reviewing official decides not to uphold effort should be made to ensure that (b) A collector should attempt to the suspension or proposed revocation, blind samples are submitted quarterly. distribute the required number of blind the suspension must terminate (c) Approximately 75 percent of the samples randomly with donor immediately and any proposed blind samples submitted each year by specimens rather than submitting the revocation shall not take effect. an agency must be negative, 15 percent full complement of blind samples as a (d) The Secretary will publish in the must be positive for one or more drugs, single group. Federal Register the name, address, and and 10 percent must either be Section 10.4 What happens if an telephone number of any HHS-certified adulterated or substituted. inconsistent result is reported for a laboratory or IITF that has its Section 10.2 What are the blind sample? certification revoked or suspended requirements for blind samples? under Section 9.13 or Section 9.14, If an HHS-certified laboratory or IITF respectively, and the name of any HHS- (a) Drug positive blind samples must reports a result for a blind sample that certified laboratory or IITF that has its be validated by the supplier as to their is inconsistent with the expected result suspension lifted. The Secretary shall content using appropriate initial and (e.g., a laboratory or IITF reports a provide to any member of the public confirmatory tests. negative result for a blind sample that upon request the written notice (1) Drug positive blind samples must was supposed to be positive, a provided to a laboratory or IITF that has be fortified with one or more of the laboratory reports a positive result for a its HHS certification suspended or drugs or metabolites listed in Section blind sample that was supposed to be revoked, as well as the reviewing 3.4. negative): official’s written decision which (2) Drug positive blind samples must (a) The MRO must contact the upholds or denies the suspension or contain concentrations of drugs between laboratory or IITF and attempt to proposed revocation under the 1.5 and 2 times the initial drug test determine if the laboratory or IITF made procedures of Subpart P. cutoff concentration. an error during the testing or reporting (b) Drug negative blind samples (i.e., of the sample; Section 9.18 May a laboratory or IITF certified to contain no drugs) must be (b) The MRO must contact the blind that had its HHS certification revoked validated by the supplier as negative sample supplier and attempt to be recertified to test federal agency using appropriate initial and determine if the supplier made an error specimens? confirmatory tests. during the preparation or transfer of the Following revocation, a laboratory or (c) A blind sample that is adulterated sample; IITF may apply for recertification. must be validated using appropriate (c) The MRO must contact the Unless otherwise provided by the initial and confirmatory specimen collector and determine if the collector Secretary in the notice of revocation validity tests, and have the made an error when preparing the blind under Section 9.17 or the reviewing characteristics to clearly show that it is sample for transfer to the HHS-certified official’s decision under Section 16.9(e) an adulterated sample at the time of laboratory or IITF; or 16.14(a), a laboratory or IITF which validation. (d) If there is no obvious reason for (d) A blind sample that is substituted has had its certification revoked may the inconsistent result, the MRO must must be validated using appropriate reapply for HHS certification as an notify both the federal agency for which initial and confirmatory specimen applicant laboratory or IITF. the blind sample was submitted and the validity tests, and have the Secretary; and Section 9.19 Where is the list of HHS- characteristics to clearly show that it is (e) The Secretary shall investigate the certified laboratories and IITFs a substituted sample at the time of blind sample error. A report of the published? validation. Secretary’s investigative findings and (e) The supplier must provide (a) The list of HHS-certified the corrective action taken in response information on the blind samples’ laboratories and IITFs is published to identified deficiencies must be sent to content, validation, expected results, monthly in the Federal Register. This the federal agency. The Secretary shall and stability to the collection site/ notice is also available on the Internet ensure notification of the finding as collector sending the blind samples to at http://www.samhsa.gov/workplace. appropriate to other federal agencies the laboratory or IITF, and must provide (b) An applicant laboratory or IITF is and coordinate any necessary actions to the information upon request to the not included on the list. prevent the recurrence of the error. MRO, the federal agency for which the Subpart J—Blind Samples Submitted by blind sample was submitted, or the Subpart K—Laboratory an Agency Secretary. Section 11.1 What must be included in Section 10.1 What are the requirements Section 10.3 How is a blind sample the HHS-certified laboratory’s standard for federal agencies to submit blind submitted to an HHS-certified operating procedure manual? samples to HHS-certified laboratories or laboratory or IITF? (a) An HHS-certified laboratory must IITFs? (a) A blind sample must be submitted have a standard operating procedure (a) Each federal agency is required to as a split specimen (specimens A and B) (SOP) manual that describes, in detail, submit blind samples for its workplace with the current Federal CCF that the all HHS-certified laboratory operations. drug testing program. The collector HHS-certified laboratory or IITF uses for When followed, the SOP manual must send the blind samples to the donor specimens. The collector ensures that all specimens are tested HHS-certified laboratory or IITF that the provides the required information to using the same procedures. collector sends employee specimens. ensure that the Federal CCF has been (b) The SOP manual must include at (b) Each federal agency must submit properly completed and provides a minimum, but is not limited to, a at least 3 percent blind samples along fictitious initials on the specimen label/ detailed description of the following:

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(1) Chain of custody procedures; or in analysis of performance testing Secretary’s approval of a new (2) Accessioning; samples; and inspection deficiencies. permanent RP or alternate RP. (3) Security; The RP must ensure that specimen (b) If the RP leaves an HHS-certified (4) Quality control/quality assurance results are not reported until all laboratory: programs; corrective actions have been taken and (1) The HHS-certified laboratory may (5) Analytical methods and that the results provided are accurate maintain certification and continue procedures; and reliable. testing federally regulated specimens (6) Equipment and maintenance under the direction of an alternate RP programs; Section 11.3 What scientific for a period of up to 180 days while (7) Personnel training; qualifications must the RP have? seeking to hire and receive the (8) Reporting procedures; and The RP must have documented Secretary’s approval of the RP’s (9) Computers, software, and scientific qualifications in analytical replacement. laboratory information management toxicology. (2) The Secretary, in accordance with systems. Minimum qualifications are: these Guidelines, will suspend a (c) All procedures in the SOP manual (a) Certification or licensure as a laboratory’s HHS certification for all must be compliant with these laboratory director by the state in federally regulated specimens if the Guidelines and all guidance provided forensic or clinical laboratory laboratory does not have a permanent by the Secretary. toxicology, a Ph.D. in one of the natural RP within 180 days. The suspension (d) A copy of all procedures that have sciences, or training and experience will be lifted upon the Secretary’s been replaced or revised and the dates comparable to a Ph.D. in one of the approval of the new permanent RP. on which the procedures were in effect natural sciences with training and (c) To nominate an individual as an must be maintained for at least 2 years. laboratory/research experience in RP or alternate RP, the HHS-certified Section 11.2 What are the biology, chemistry, and pharmacology laboratory must submit the following responsibilities of the responsible or toxicology; documents to the Secretary: The person (RP)? (b) Experience in forensic toxicology candidate’s current resume or with emphasis on the collection and curriculum vitae, copies of diplomas (a) Manage the day-to-day operations analysis of biological specimens for and licensures, a training plan (not to of the HHS-certified laboratory even if drugs of abuse; exceed 90 days) to transition the another individual has overall (c) Experience in forensic applications candidate into the position, an itemized responsibility for alternate areas of a of analytical toxicology (e.g., comparison of the candidate’s multi-specialty laboratory. publications, court testimony, qualifications to the minimum RP (b) Ensure that there are sufficient conducting research on the qualifications described in the personnel with adequate training and pharmacology and toxicology of drugs Guidelines, and have official academic experience to supervise and conduct the of abuse) or qualify as an expert witness transcript(s) submitted from the work of the HHS-certified laboratory. in forensic toxicology; candidate’s institution(s) of higher The RP must ensure the continued (d) Fulfillment of the RP learning. The candidate must be found competency of laboratory staff by responsibilities and qualifications, as qualified during an on-site inspection of documenting their in-service training, demonstrated by the HHS-certified the HHS-certified laboratory. reviewing their work performance, and laboratory’s performance and verified (d) The HHS-certified laboratory must verifying their skills. upon interview by HHS-trained fulfill additional inspection and PT (c) Maintain a complete and current inspectors during each on-site criteria as required prior to conducting SOP manual that is available to all inspection; and federally regulated testing under a new personnel of the HHS-certified (e) Qualify as a certifying scientist. RP. laboratory and ensure that it is followed. The SOP manual must be reviewed, Section 11.4 What happens when the Section 11.5 What qualifications must signed, and dated by the RP(s) when RP is absent or leaves an HHS-certified an individual have to certify a result procedures are first placed into use and laboratory? reported by an HHS-certified when changed or when a new (a) HHS-certified laboratories must laboratory? individual assumes responsibility for have multiple RPs or one RP and an (a) A certifying scientist must have: the management of the HHS-certified alternate RP. If the RP(s) are (1) At least a bachelor’s degree in the laboratory. The SOP must be reviewed concurrently absent, an alternate RP chemical or biological sciences or and documented by the RP annually. must be present and qualified to fulfill medical technology, or equivalent; (d) Maintain a quality assurance the responsibilities of the RP. (2) Training and experience in the program that ensures the proper (1) If an HHS-certified laboratory is analytical methods and forensic performance and reporting of all test without the RP and alternate RP for 14 procedures used by the HHS-certified results; verify and monitor acceptable calendar days or less (e.g., temporary laboratory relevant to the results that the analytical performance for all controls absence due to vacation, illness, or individual certifies; and and calibrators; monitor quality control business trip), the HHS-certified (3) Training and experience in testing; and document the validity, laboratory may continue operations and reviewing and reporting forensic test reliability, accuracy, precision, and testing of federal agency specimens results and maintaining chain of performance characteristics of each test under the direction of a certifying custody, and an understanding of and test system. scientist. appropriate remedial actions in (e) Initiate and implement all (2) The Secretary, in accordance with response to problems that may arise. remedial actions necessary to maintain these Guidelines, will suspend a (b) A certifying technician must have: satisfactory operation and performance laboratory’s HHS certification for all (1) Training and experience in the of the HHS-certified laboratory in specimens if the laboratory does not analytical methods and forensic response to the following: Quality have an RP or alternate RP for a period procedures used by the HHS-certified control systems not within performance of more than 14 calendar days. The laboratory relevant to the results that the specifications; errors in result reporting suspension will be lifted upon the individual certifies; and

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(2) Training and experience in specimen or aliquot is handled or (1) At least one control certified to reviewing and reporting forensic test transferred, and every individual in the contain no drug or drug metabolite; results and maintaining chain of chain must be identified. (2) At least one positive control with custody, and an understanding of (e) The date and purpose must be the drug or drug metabolite targeted at appropriate remedial actions in recorded on an appropriate chain of a concentration 25 percent above the response to problems that may arise. custody form each time a specimen or cutoff; aliquot is handled or transferred. (3) At least one control with the drug Section 11.6 What qualifications and or drug metabolite targeted at a training must other personnel of an Section 11.9 What test(s) does an concentration 75 percent of the cutoff; HHS-certified laboratory have? HHS-certified laboratory conduct on a and (a) All HHS-certified laboratory staff urine specimen received from an IITF? (4) At least one control that appears (e.g., technicians, administrative staff) An HHS-certified laboratory must test as a donor specimen to the analysts. must have the appropriate training and the specimen in the same manner as a (b) Calibrators and controls must total skills for the tasks they perform. specimen that had not been previously at least 10 percent of the aliquots (b) Each individual working in an tested. analyzed in each batch. HHS-certified laboratory must be Section 11.13 What are the properly trained (i.e., receive training in Section 11.10 What are the requirements for an initial drug test? requirements for a confirmatory drug each area of work that the individual test? will be performing, including training in (a) An initial drug test may be: forensic procedures related to their job (1) An immunoassay or (a) The analytical method must use duties) before they are permitted to (2) An alternate technology (e.g., mass spectrometric identification [e.g., work independently with federally spectrometry, spectroscopy). gas chromatography/mass spectrometry regulated specimens. All training must (b) An HHS-certified laboratory must (GC/MS), liquid chromatography/mass be documented. validate an initial drug test before spectrometry (LC/MS), GC/MS/MS, LC/ testing specimens. MS/MS] or equivalent. Section 11.7 What security measures (c) Initial drug tests must be accurate (b) A confirmatory drug test must be must an HHS-certified laboratory and reliable for the testing of specimens validated before it can be used to test maintain? when identifying drugs or their federally regulated specimens. (a) An HHS-certified laboratory must metabolites. (c) Confirmatory drug tests must be control access to the drug testing (d) An HHS-certified laboratory may accurate and reliable for the testing of a facility, specimens, aliquots, and conduct a second initial drug test using urine specimen when identifying and records. a method with different specificity, to quantifying drugs or their metabolites. (b) Authorized visitors must be rule out cross-reacting compounds. This Section 11.14 What must an HHS- escorted at all times, except for second initial drug test must satisfy the certified laboratory do to validate a individuals conducting inspections (i.e., batch quality control requirements confirmatory drug test? for the Department, a federal agency, a specified in Section 11.12. state, or other accrediting agency) or (a) An HHS-certified laboratory must Section 11.11 What must an HHS- emergency personnel (e.g., firefighters demonstrate and document the certified laboratory do to validate an and medical rescue teams). following for each confirmatory drug (c) An HHS-certified laboratory must initial drug test? test: maintain records documenting the (a) An HHS-certified laboratory must (1) The linear range of the analysis; identity of the visitor and escort, date, demonstrate and document the (2) The limit of detection; (3) The limit of quantification; time of entry and exit, and purpose for following for each initial drug test: (4) The accuracy and precision at the (1) The ability to differentiate negative access to the secured area. cutoff concentration; specimens from those requiring further Section 11.8 What are the laboratory (5) The accuracy (bias) and precision testing; at 40 percent of the cutoff concentration; chain of custody requirements for (2) The performance of the test around specimens and aliquots? (6) The potential for interfering the cutoff concentration, using samples substances; (a) HHS-certified laboratories must at several concentrations between 0 and (7) The potential for carryover; and use chain of custody procedures 150 percent of the cutoff concentration; (8) The potential matrix effects if (internal and external) to maintain (3) The effective concentration range using liquid chromatography coupled control and accountability of specimens of the test (linearity); with mass spectrometry. from the time of receipt at the laboratory (4) The potential for carryover; (b) Each new lot of reagent must be through completion of testing, reporting (5) The potential for interfering verified prior to being placed into of results, during storage, and substances; and service. continuing until final disposition of the (6) The potential matrix effects if (c) HHS-certified laboratories must re- specimens. using an alternate technology. verify each confirmatory drug test (b) HHS-certified laboratories must (b) Each new lot of reagent must be method periodically or at least annually. use chain of custody procedures to verified prior to being placed into document the handling and transfer of service. Section 11.15 What are the batch aliquots throughout the testing process (c) Each initial drug test using an quality control requirements when until final disposal. alternate technology must be re-verified conducting a confirmatory drug test? (c) The chain of custody must be periodically or at least annually. (a) At a minimum, each batch of documented using either paper copy or specimens must contain the following Section 11.12 What are the batch electronic procedures. calibrators and controls: quality control requirements when (d) Each individual who handles a (1) A calibrator at the cutoff conducting an initial drug test? specimen or aliquot must sign and concentration; complete the appropriate entries on the (a) Each batch of specimens must (2) At least one control certified to chain of custody form when the contain the following controls: contain no drug or drug metabolite;

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(3) At least one positive control with (b) The requirements for measuring (3) pH screening tests must have, at a the drug or drug metabolite targeted at specific gravity are as follows: minimum, the following controls: 25 percent above the cutoff; and (1) For specimens with initial (i) One control below the lower (4) At least one control targeted at or creatinine test results greater than 5 mg/ decision point in use; less than 40 percent of the cutoff. dL and less than 20 mg/dL, laboratories (ii) One control between the decision (b) Calibrators and controls must total may perform a screening test using a points in use; and at least 10 percent of the aliquots refractometer that measures urine (iii) One control above the upper analyzed in each batch. specific gravity to at least three decimal decision point in use; (4) An initial colorimetric pH test Section 11.16 What are the analytical places to identify specific gravity values that are acceptable (equal to or greater must have the following calibrators and and quality control requirements for controls: conducting specimen validity tests? than 1.003) or dilute (equal to or greater than 1.002 and less than 1.003). (i) One calibrator at 4; (a) Each invalid, adulterated, or Specimens must be subjected to an (ii) One calibrator at 11; substituted specimen validity test result initial specific gravity test using a four (iii) One control in the range of 3 to must be based on an initial specimen decimal place refractometer when the 3.8; validity test on one aliquot and a initial creatinine test result is less than (iv) One control in the range 4.2 to 5; confirmatory specimen validity test on a or equal to 5 mg/dL or when the (v) One control in the range of 5 to 9; second aliquot; screening specific gravity test result (vi) One control in the range of 10 to (b) The HHS-certified laboratory must using a three decimal place 10.8; and establish acceptance criteria and refractometer is less than 1.002. (vii) One control in the range of 11.2 analyze calibrators and controls as (2) The screening specific gravity test to 12; appropriate to verify and document the must have the following calibrators and (5) An initial pH meter test, if a pH validity of the test results (required controls: screening test is not used, must have the specimen validity tests are addressed in (i) A calibrator or control at 1.000; following calibrators and controls: (i) One calibrator at 3; Section 11.18); and (ii) One control targeted at 1.002; (ii) One calibrator at 7; (c) Controls must be analyzed (iii) One control in the range of 1.004 concurrently with specimens. (iii) One calibrator at 10; to 1.018. (iv) One control in the range of 3 to Section 11.17 What must an HHS- (3) For the initial and confirmatory 3.8; certified laboratory do to validate a specific gravity tests, the refractometer (v) One control in the range 4.2 to 5; specimen validity test? must report and display specific gravity (vi) One control in the range of 10 to to four decimal places. The An HHS-certified laboratory must 10.8; and refractometer must be interfaced with a demonstrate and document for each (vii) One control in the range of 11.2 laboratory information management specimen validity test the appropriate to 12; system (LIMS), computer, and/or performance characteristics of the test, (6) An initial pH meter test (if a pH generate a paper copy of the digital and must re-verify the test periodically, screening test is used) or confirmatory electronic display to document the or at least annually. Each new lot of pH meter test must have the following numerical values of the specific gravity reagent must be verified prior to being calibrators and controls when the result test results; placed into service. of the preceding pH test indicates that (4) The initial and confirmatory the pH is below the lower decision Section 11.18 What are the specific gravity tests must have the point in use: requirements for conducting each following calibrators and controls: (i) One calibrator at 4; specimen validity test? (i) A calibrator or control at 1.0000; (ii) One calibrator at 7; (a) The requirements for measuring (ii) One control targeted at 1.0020; (iii) One control in the range of 3 to creatinine concentration are as follows: (iii) One control in the range of 1.0040 3.8; and (1) The creatinine concentration must to 1.0180; and (iv) One control in the range 4.2 to 5; be measured to one decimal place on (iv) One control equal to or greater and both the initial creatinine test and the than 1.0200 but not greater than 1.0250. (7) An initial pH meter test (if a pH confirmatory creatinine test; (c) Requirements for measuring pH screening test is used) or confirmatory (2) The initial creatinine test must are as follows: pH meter test must have the following have the following calibrators and (1) Colorimetric pH tests that have the calibrators and controls when the result controls: dynamic range of 3 to 12 to support the of the preceding pH test indicates that (i) A calibrator at 2 mg/dL; 4 and 11 pH cutoffs and pH meters must the pH is above the upper decision (ii) A control in the range of 1.0 mg/ be capable of measuring pH to one point in use: dL to 1.5 mg/dL; decimal place. Colorimetric pH tests, (i) One calibrator at 7; (iii) A control in the range of 3 mg/ dipsticks, and pH paper (i.e., screening (ii) One calibrator at 10; dL to 20 mg/dL; and tests) that have a narrow dynamic range (iii) One control in the range of 10 to (iv) A control in the range of 21 mg/ and do not support the cutoffs may be 10.8; and dL to 25 mg/dL. used only to determine if an initial pH (iv) One control in the range of 11.2 (3) The confirmatory creatinine test specimen validity test must be to 12. (performed on those specimens with a performed; (d) Requirements for performing creatinine concentration less than 2 mg/ (2) For the initial and confirmatory oxidizing adulterant tests are as follows: dL on the initial test) must have the pH tests, the pH meter must report and (1) The initial test must include an following calibrators and controls: display pH to at least one decimal place. appropriate calibrator at the cutoff (i) A calibrator at 2 mg/dL; The pH meter must be interfaced with specified in Sections 11.19(d)(2), (3), or (ii) A control in the range of 1.0 mg/ a LIMS, computer, and/or generate a (4) for the compound of interest, a dL to 1.5 mg/dL; and paper copy of the digital electronic control without the compound of (iii) A control in the range of 3 mg/ display to document the numerical interest (i.e., a certified negative dL to 4 mg/dL. values of the pH test results; control), and at least one control with

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one of the compounds of interest at a colorimetric test (chromium (VI) dodecylbenzene sulfonate-equivalent measurable concentration; and concentration equal to or greater than 50 cutoff on the second aliquot; or (2) A confirmatory test for a specific mcg/mL) for the initial test on the first (8) The presence of any other oxidizing adulterant must use a aliquot and a different confirmatory test adulterant not specified in paragraphs different analytical method than that (e.g., multi-wavelength d(2) through d(7) of this section is used for the initial test. Each spectrophotometry, ion verified using an initial test on the first confirmatory test batch must include an chromatography, atomic absorption aliquot and a different confirmatory test appropriate calibrator, a control without spectrophotometry, capillary on the second aliquot. the compound of interest (i.e., a electrophoresis, inductively coupled (e) A primary (A) urine specimen is certified negative control), and a control plasma-mass spectrometry) with the reported substituted when the with the compound of interest at a chromium (VI) concentration equal to or creatinine concentration is less than 2 measurable concentration. greater than the LOQ of the mg/dL and the specific gravity is less (e) The requirements for measuring confirmatory test on the second aliquot; than or equal to 1.0010 or equal to or the nitrite concentration are that the (4) The presence of halogen (e.g., greater than 1.0200 on both the initial initial and confirmatory nitrite tests bleach, iodine, fluoride) is verified and confirmatory creatinine tests (i.e., must have a calibrator at the cutoff using either a general oxidant the same colorimetric test may be used concentration, a control without nitrite colorimetric test (with an equal to or to test both aliquots) and on both the (i.e., certified negative urine), one greater than 200 mcg/mL nitrite- initial and confirmatory specific gravity control in the range of 200 mcg/mL to equivalent cutoff or an equal to or tests (i.e., a refractometer is used to test 250 mcg/mL, and one control in the greater than 50 mcg/mL chromium (VI)- both aliquots) on two separate aliquots. range of 500 mcg/mL to 625 mcg/mL. equivalent cutoff) or halogen (f) A primary (A) urine specimen is colorimetric test (halogen concentration reported dilute when the creatinine Section 11.19 What are the equal to or greater than the LOQ) for the concentration is equal to or greater than requirements for an HHS-certified initial test on the first aliquot and a 2 mg/dL but less than 20 mg/dL and the laboratory to report a test result? different confirmatory test (e.g., multi- specific gravity is greater than 1.0010 (a) Laboratories must report a test wavelength spectrophotometry, ion but less than 1.0030 on a single aliquot. result to the agency’s MRO within an chromatography, inductively coupled (g) For a specimen that has an invalid average of 5 working days after receipt plasma-mass spectrometry) with a result for one of the reasons stated in of the specimen. Reports must use the specific halogen concentration equal to items (h)(4) through (h)(12) below, the Federal CCF and/or an electronic report. or greater than the LOQ of the HHS-certified laboratory shall contact Before any test result can be reported, it confirmatory test on the second aliquot; the MRO and both will decide if testing must be certified by a certifying scientist (5) The presence of glutaraldehyde is by another HHS-certified laboratory or a certifying technician (as verified using either an aldehyde test would be useful in being able to report appropriate). (aldehyde present) or the characteristic a positive or adulterated result. If no (b) A primary (A) specimen is immunoassay response on one or more further testing is necessary, the HHS- reported negative when each initial drug drug immunoassay tests for the initial certified laboratory then reports the test is negative or if the specimen is test on the first aliquot and a different invalid result to the MRO. negative upon confirmatory drug confirmatory method (e.g., GC/MS) for (h) A primary (A) urine specimen is testing, and the specimen does not meet the confirmatory test with the reported as an invalid result when: invalid criteria as described in items glutaraldehyde concentration equal to or (1) Inconsistent creatinine (h)(1) through (h)(12) below. greater than the LOQ of the analysis on concentration and specific gravity (c) A primary (A) specimen is the second aliquot; results are obtained (i.e., the creatinine reported positive for a specific drug or (6) The presence of pyridine concentration is less than 2 mg/dL on drug metabolite when both the initial (pyridinium chlorochromate) is verified both the initial and confirmatory drug test is positive and the using either a general oxidant creatinine tests and the specific gravity confirmatory drug test is positive in colorimetric test (with an equal to or is greater than 1.0010 but less than accordance with Section 3.4. greater than 200 mcg/mL nitrite- 1.0200 on the initial and/or (d) A primary (A) urine specimen is equivalent cutoff or an equal to or confirmatory specific gravity test, the reported adulterated when: greater than 50 mcg/mL chromium (VI)- specific gravity is less than or equal to (1) The pH is less than 4 or equal to equivalent cutoff) or a chromium (VI) 1.0010 on both the initial and or greater than 11 using either a pH colorimetric test (chromium (VI) confirmatory specific gravity tests and meter or a colorimetric pH test for the concentration equal to or greater than 50 the creatinine concentration is equal to initial test on the first aliquot and a pH mcg/mL) for the initial test on the first or greater than 2 mg/dL on either or meter for the confirmatory test on the aliquot and a different confirmatory both the initial or confirmatory second aliquot; method (e.g., GC/MS) for the creatinine tests); (2) The nitrite concentration is equal confirmatory test with the pyridine (2) The pH is equal to or greater than to or greater than 500 mcg/mL using concentration equal to or greater than 4 and less than 4.5 or equal to or greater either a nitrite colorimetric test or a the LOQ of the analysis on the second than 9 and less than 11 using either a general oxidant colorimetric test for the aliquot; colorimetric pH test or pH meter for the initial test on the first aliquot and a (7) The presence of a surfactant is initial test and a pH meter for the different confirmatory test (e.g., multi- verified by using a surfactant confirmatory test on two separate wavelength spectrophotometry, ion colorimetric test with an equal to or aliquots; chromatography, capillary greater than 100 mcg/mL (3) The nitrite concentration is equal electrophoresis) on the second aliquot; dodecylbenzene sulfonate-equivalent to or greater than 200 mcg/mL using a (3) The presence of chromium (VI) is cutoff for the initial test on the first nitrite colorimetric test or equal to or verified using either a general oxidant aliquot and a different confirmatory test greater than the equivalent of 200 mcg/ colorimetric test (with an equal to or (e.g., multi-wavelength mL nitrite using a general oxidant greater than 50 mcg/mL chromium (VI)- spectrophotometry) with an equal to or colorimetric test for both the initial equivalent cutoff) or a chromium (VI) greater than 100 mcg/mL (first) test and the second test or using

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either initial test and the nitrite (i) An HHS-certified laboratory shall a legible image or copy of the completed concentration is equal to or greater than reject a primary (A) specimen for testing Federal CCF. 200 mcg/mL but less than 500 mcg/mL when a fatal flaw occurs as described in Section 11.20 How long must an HHS- for a different confirmatory test (e.g., Section 15.1 or when a correctable flaw certified laboratory retain specimens? multi-wavelength spectrophotometry, as described in Section 15.2 is not ion chromatography, capillary recovered. The HHS-certified laboratory (a) An HHS-certified laboratory must electrophoresis) on two separate will indicate on the Federal CCF that retain specimens that were reported as aliquots; the specimen was rejected for testing positive, adulterated, substituted, or as (4) The possible presence of and provide the reason for reporting the an invalid result for a minimum of 1 chromium (VI) is determined using the rejected for testing result. year. same chromium (VI) colorimetric test (j) An HHS-certified laboratory must (b) Retained specimens must be kept with a cutoff equal to or greater than 50 report all positive, adulterated, in secured frozen storage (¥20 °C or mcg/mL chromium (VI) for both the substituted, and invalid test results for less) to ensure their availability for initial (first) test and the second test on a urine specimen. For example, a retesting during an administrative or two separate aliquots; specimen can be positive for a specific judicial proceeding. (5) The possible presence of a halogen drug and adulterated. (c) Federal agencies may request that (e.g., bleach, iodine, fluoride) is (k) An HHS-certified laboratory must the HHS-certified laboratory retain a determined using the same halogen report the confirmatory concentration of specimen for an additional specified colorimetric test with a cutoff equal to each drug or drug metabolite reported period of time and must make that or greater than the LOQ for both the for a positive result. request within the 1-year period. (l) An HHS-certified laboratory must initial (first) test and the second test on report numerical values of the specimen Section 11.21 How long must an HHS- two separate aliquots or relying on the validity test results that support a certified laboratory retain records? odor of the specimen as the initial test; specimen that is reported adulterated, (6) The possible presence of (a) An HHS-certified laboratory must substituted, or invalid (as appropriate). retain all records generated to support glutaraldehyde is determined by using (m) When the concentration of a drug test results for at least 2 years. The the same aldehyde test (aldehyde or drug metabolite exceeds the validated laboratory may convert hardcopy present) or characteristic immunoassay linear range of the confirmatory test, response on one or more drug HHS-certified laboratories may report to records to electronic records for storage immunoassay tests for both the initial the MRO that the quantitative value and then discard the hardcopy records (first) test and the second test on two exceeds the linear range of the test or after 6 months. separate aliquots; that the quantitative value is greater (b) A federal agency may request the (7) The possible presence of an than ‘‘insert the actual value for the HHS-certified laboratory to maintain a oxidizing adulterant is determined by upper limit of the linear range,’’ or documentation package (as described in using the same general oxidant laboratories may report a quantitative Section 11.23) that supports the chain of colorimetric test (with an equal to or value above the upper limit of the linear custody, testing, and reporting of a greater than 200 mcg/mL nitrite- range that was obtained by diluting an donor’s specimen that is under legal equivalent cutoff, an equal to or greater aliquot of the specimen to achieve a challenge by a donor. The federal than 50 mcg/mL chromium (VI)- result within the method’s linear range agency’s request to the laboratory must equivalent cutoff, or a halogen and multiplying the result by the be in writing and must specify the concentration is equal to or greater than appropriate dilution factor. period of time to maintain the the LOQ) for both the initial (first) test (n) HHS-certified laboratories may documentation package. and the second test on two separate transmit test results to the MRO by (c) An HHS-certified laboratory may aliquots; various electronic means (e.g., retain records other than those included (8) The possible presence of a teleprinter, facsimile, or computer). in the documentation package beyond surfactant is determined by using the Transmissions of the reports must the normal 2-year period of time. same surfactant colorimetric test with ensure confidentiality and the results Section 11.22 What statistical an equal to or greater than 100 mcg/mL may not be reported verbally by summary reports must an HHS-certified dodecylbenzene sulfonate-equivalent telephone. Laboratories and external laboratory provide for urine testing? cutoff for both the initial (first) test and service providers must ensure the the second test on two separate aliquots confidentiality, integrity, and (a) HHS-certified laboratories must or a foam/shake test for the initial test; availability of the data and limit access provide to each federal agency for (9) Interference occurs on the initial to any data transmission, storage, and which they perform testing a drug tests on two separate aliquots (i.e., retrieval system. semiannual statistical summary report valid initial drug test results cannot be (o) HHS-certified laboratories must that must be submitted by mail, obtained); facsimile, courier, mail, or electronically facsimile, or email within 14 working (10) Interference with the transmit a legible image or copy of the days after the end of the semiannual confirmatory drug test occurs on at least completed Federal CCF and/or forward period. The summary report must not two separate aliquots of the specimen a computer-generated electronic report. include any personal identifying and the HHS-certified laboratory is The computer-generated report must information. A copy of the semiannual unable to identify the interfering contain sufficient information to ensure statistical summary report will also be substance; that the test results can accurately sent to the Secretary or designated HHS (11) The physical appearance of the represent the content of the custody and representative. The semiannual specimen is such that testing the control form that the MRO received statistical report contains the following specimen may damage the laboratory’s from the collector. information: instruments; or (p) For positive, adulterated, (1) Reporting period (inclusive dates); (12) The physical appearances of the substituted, invalid, and rejected (2) HHS-certified laboratory name and A and B specimens are clearly different specimens, laboratories must facsimile, address; (note: A is tested). courier, mail, or electronically transmit (3) Federal agency name;

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(4) Number of specimen results (5) Copies of the initial test data for Section 11.26 What type of reported; the donor’s specimen with all relationship can exist between an HHS- (5) Number of specimens collected by calibrators and controls and copies of all certified laboratory and an HHS- reason for test; internal chain of custody documents certified IITF? (6) Number of specimens reported related to the initial tests; An HHS-certified laboratory can enter negative and the number reported into any relationship with an HHS- negative/dilute; (6) A brief description of the HHS- certified IITF. (7) Number of specimens rejected for certified laboratory’s confirmatory drug testing because of a fatal flaw; (and specimen validity, if applicable) Subpart L—Instrumented Initial Test (8) Number of specimens rejected for testing procedures, instrumentation, and Facility (IITF) testing because of an uncorrected flaw; batch quality control requirements; Section 12.1 What must be included in (9) Number of specimens tested (7) Copies of the confirmatory test positive by each initial drug test; the HHS-certified IITF’s standard data for the donor’s specimen with all operating procedure manual? (10) Number of specimens reported calibrators and controls and copies of all positive; internal chain of custody documents (a) An HHS-certified IITF must have (11) Number of specimens reported related to the confirmatory tests; and a standard operating procedure (SOP) positive for each drug and drug manual that describes, in detail, all metabolite; (8) Copies of the re´sume´ or HHS-certified IITF operations. When (12) Number of specimens reported curriculum vitae for the RP(s) and the followed, the SOP manual ensures that adulterated; certifying technician or certifying all specimens are tested consistently (13) Number of specimens reported scientist of record. using the same procedures. substituted; and Section 11.24 What HHS-certified (b) The SOP manual must include at (14) Number of specimens reported as a minimum, but is not limited to, a laboratory information is available to a invalid result. detailed description of the following: federal employee? (b) An HHS-certified laboratory must (1) Chain of custody procedures; make copies of an agency’s test results A federal employee who is the subject (2) Accessioning; available when requested to do so by the of a workplace drug test may submit a (3) Security; Secretary or by the federal agency for written request through the MRO and/ (4) Quality control/quality assurance which the laboratory is performing programs; or the federal agency requesting copies drug-testing services. (5) Analytical methods and of any records relating to the employee’s (c) An HHS-certified laboratory must procedures; ensure that a qualified individual is drug test results or a documentation (6) Equipment and maintenance available to testify in a proceeding package as described in Section 11.23(b) programs; against a federal employee when the and any relevant certification, review, or (7) Personnel training; proceeding is based on a test result revocation of certification records. (8) Reporting procedures; and reported by the laboratory. Federal employees, or their designees, (9) Computers, software, and are not permitted access to their laboratory information management Section 11.23 What HHS-certified specimens collected pursuant to systems. laboratory information is available to a Executive Order 12564, Public Law (c) All procedures in the SOP manual federal agency? 100–71, and these Guidelines. must be compliant with these (a) Following a federal agency’s Guidelines and all guidance provided receipt of a positive, adulterated, or Section 11.25 What types of by the Secretary. substituted drug test report, the federal relationships are prohibited between an (d) A copy of all procedures that have agency may submit a written request for HHS-certified laboratory and an MRO? been replaced or revised and the dates copies of the records relating to the drug on which the procedures were in effect An HHS-certified laboratory must not test results or a documentation package must be maintained for two years. enter into any relationship with a or any relevant certification, review, or Section 12.2 What are the revocation of certification records. federal agency’s MRO that may be (b) Standard documentation packages construed as a potential conflict of responsibilities of the responsible provided by an HHS-certified laboratory interest or derive any financial benefit technician (RT)? must contain the following items: by having a federal agency use a specific (a) Manage the day-to-day operations (1) A cover sheet providing a brief MRO. of the HHS-certified IITF even if another description of the procedures and tests This means an MRO may be an individual has overall responsibility for performed on the donor’s specimen; employee of the agency or a contractor alternate areas of a multi-specialty (2) A table of contents that lists all for the agency; however, an MRO shall facility. documents and materials in the package not be an employee or agent of or have (b) Ensure that there are sufficient by page number; any financial interest in the HHS- personnel with adequate training and (3) A copy of the Federal CCF with certified laboratory for which the MRO experience to supervise and conduct the any attachments, internal chain of is reviewing drug testing results. work of the HHS-certified IITF. The RT custody records for the specimen, must ensure the continued competency Additionally, an MRO shall not derive memoranda (if any) generated by the of IITF personnel by documenting their any financial benefit by having an HHS-certified laboratory, and a copy of in-service training, reviewing their work agency use a specific HHS-certified the electronic report (if any) generated performance, and verifying their skills. by the HHS-certified laboratory; laboratory or have any agreement with (c) Maintain a complete and current (4) A brief description of the HHS- an HHS-certified laboratory that may be SOP manual that is available to all certified laboratory’s initial drug and construed as a potential conflict of personnel of the HHS-certified IITF, and specimen validity testing procedures, interest. ensure that it is followed. The SOP instrumentation, and batch quality manual must be reviewed, signed, and control requirements; dated by the RT when procedures are

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first placed into use or changed or when (2) The Secretary, in accordance with Section 12.6 What qualifications and a new individual assumes responsibility these Guidelines, will suspend an IITF’s training must other personnel of an for the management of the HHS-certified HHS certification for all specimens if HHS-certified IITF have? IITF. The SOP must be reviewed and the IITF does not have an RT or (a) All HHS-certified IITF staff (e.g., documented by the RT annually. alternate RT for a period of more than technicians, administrative staff) must (d) Maintain a quality assurance 14 calendar days. The suspension will have the appropriate training and skills program that ensures the proper be lifted upon the Secretary’s approval for the tasks they perform. performance and reporting of all test of a new permanent RT or alternate RT. results; verify and monitor acceptable (b) Each individual working in an analytical performance for all controls (b) If the RT leaves an HHS-certified HHS-certified IITF must be properly and calibrators; monitor quality control IITF: trained (i.e., receive training in each testing; and document the validity, (1) The HHS-certified IITF may area of work that the individual will be reliability, accuracy, precision, and maintain certification and continue performing, including training in performance characteristics of each test testing federally regulated specimens forensic procedures related to their job duties) before they are permitted to and test system. under the direction of an alternate RT work independently with federally (e) Initiate and implement all for a period of up to 180 days while regulated specimens. All training must remedial actions necessary to maintain seeking to hire and receive the be documented. satisfactory operation and performance Secretary’s approval of the RT’s of the HHS-certified IITF in response to replacement. Section 12.7 What security measures the following: Quality control systems must an HHS-certified IITF maintain? not within performance specifications, (2) The Secretary, in accordance with errors in result reporting or in analysis these Guidelines, will suspend an IITF’s (a) An HHS-certified IITF must of performance testing samples, and HHS certification for all federally control access to the drug testing inspection deficiencies. The RT must regulated specimens if the IITF does not facility, specimens, aliquots, and ensure that specimen results are not have a permanent RT within 180 days. records. reported until all corrective actions have The suspension will be lifted upon the (b) Authorized visitors must be been taken and that the results provided Secretary’s approval of the new escorted at all times except for are accurate and reliable. permanent RT. individuals conducting inspections (i.e., (c) To nominate an individual as the for the Department, a federal agency, a Section 12.3 What qualifications must state, or other accrediting agency) or the RT have? RT or alternate RT, the HHS-certified IITF must submit the following emergency personnel (e.g., firefighters An RT must: documents to the Secretary: The and medical rescue teams). (a) Have at least a bachelor’s degree in candidate’s current re´sume´ or (c) An HHS-certified IITF must the chemical or biological sciences or curriculum vitae, copies of diplomas maintain records documenting the medical technology, or equivalent; identity of the visitor and escort, date, (b) Have training and experience in and licensures, a training plan (not to exceed 90 days) to transition the time of entry and exit, and purpose for the analytical methods and forensic the access to the secured area. procedures used by the HHS-certified candidate into the position, an itemized IITF; comparison of the candidate’s Section 12.8 What are the IITF chain (c) Have training and experience in qualifications to the minimum RT of custody requirements for specimens reviewing and reporting forensic test qualifications described in the and aliquots? results and maintaining chain of Guidelines, and have official academic (a) HHS-certified IITFs must use chain custody, and an understanding of transcript(s) submitted from the of custody procedures (internal and appropriate remedial actions in candidate’s institution(s) of higher external) to maintain control and response to problems that may arise; learning. The candidate must be found accountability of specimens from the (d) Be found to fulfill RT qualified during an on-site inspection of time of receipt at the IITF through responsibilities and qualifications, as the HHS-certified IITF. completion of testing, reporting of demonstrated by the HHS-certified (d) The HHS-certified IITF must fulfill results, during storage, and continuing IITF’s performance and verified upon additional inspection and PT criteria as until final disposition of the specimens. interview by HHS-trained inspectors required prior to conducting federally (b) HHS-certified IITFs must use during each on-site inspection; and regulated testing under a new RT. chain of custody procedures to (e) Qualify as a certifying technician. document the handling and transfer of Section 12.4 What happens when the Section 12.5 What qualifications must aliquots throughout the testing process RT is absent or leaves an HHS-certified an individual have to certify a result until final disposal. IITF? reported by an HHS-certified IITF? (c) The chain of custody must be (a) HHS-certified IITFs must have an A certifying technician must have: documented using either paper copy or electronic procedures. RT and an alternate RT. When an RT is (a) Training and experience in the (d) Each individual who handles a absent, an alternate RT must be present analytical methods and forensic and qualified to fulfill the specimen or aliquot must sign and procedures used by the HHS-certified complete the appropriate entries on the responsibilities of the RT. IITF relevant to the results that the (1) If an HHS-certified IITF is without chain of custody form when the individual certifies; and the RT and alternate RT for 14 calendar specimen or aliquot is handled or days or less (e.g., temporary absence due (b) Training and experience in transferred, and every individual in the to vacation, illness, business trip), the reviewing and reporting forensic test chain must be identified. HHS-certified IITF may continue results and maintaining chain of (e) The date and purpose must be operations and testing of federal agency custody, and an understanding of recorded on an appropriate chain of specimens under the direction of a appropriate remedial actions in custody form each time a specimen or certifying technician. response to problems that may arise. aliquot is handled or transferred.

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Section 12.9 What are the Section 12.12 What are the analytical (1) The IITF may perform the pH test requirements for an initial drug test? and quality control requirements for using a pH meter, colorimetric pH test, (a) An initial drug test may be: conducting specimen validity tests? dipsticks, or pH paper. Specimens must (1) An immunoassay or (a) Each specimen validity test result be forwarded to an HHS-certified (2) An alternate technology (e.g., must be based on performing a single laboratory when the pH is less than 4.5 spectrometry, spectroscopy). test on one aliquot; or equal to or greater than 9.0. (b) An HHS-certified IITF must (b) The HHS-certified IITF must (2) The pH test must have, at a validate an initial drug test before establish acceptance criteria and minimum, the following calibrators and testing specimens; analyze calibrators and controls as controls: (c) Initial drug tests must be accurate appropriate to verify and document the (i) One control below 4.5; (ii) One control between 4.5 and 9.0; and reliable for the testing of urine validity of the test results in accordance specimens when identifying drugs or (iii) One control above 9.0; and with Section 12.14; and (iv) One or more calibrators as their metabolites. (c) Controls must be analyzed appropriate for the test. For a pH meter: (d) An HHS-certified IITF may concurrently with specimens. conduct a second initial drug test using calibrators at 4, 7, and 10. (d) The requirements for measuring a method with different specificity, to Section 12.13 What must an HHS- the nitrite concentration are that the rule out cross-reacting compounds. This certified IITF do to validate a specimen nitrite test must have a calibrator at 200 second initial drug test must satisfy the validity test? mcg/mL nitrite, a control without nitrite batch quality control requirements An HHS-certified IITF must (i.e., certified negative urine), one specified in Section 12.11. demonstrate and document for each control in the range of 200 mcg/mL to specimen validity test the appropriate Section 12.10 What must an HHS- 250 mcg/mL, and one control in the performance characteristics of the test, certified IITF do to validate an initial range of 500 mcg/mL to 625 mcg/mL. and must re-verify the test periodically, drug test? Specimens with a nitrite concentration or at least annually. Each new lot of equal to or greater than 200 mcg/mL (a) An HHS-certified IITF must reagent must be verified prior to being must be forwarded to an HHS-certified demonstrate and document the placed into service. following for each initial drug test: laboratory; and, (1) The ability to differentiate negative Section 12.14 What are the (e) Requirements for performing specimens from those requiring further requirements for conducting each oxidizing adulterant tests are that the testing; specimen validity test? test must include an appropriate (2) The performance of the test around (a) The requirements for measuring calibrator at the cutoff specified in the cutoff concentration, using samples creatinine concentration are as follows: Sections 11.19(d)(3), (4), or (6) for the at several concentrations between 0 and (1) The creatinine concentration must compound of interest, a control without 150 percent of the cutoff concentration; be measured to one decimal place on the compound of interest (i.e., a (3) The effective concentration range the test; certified negative control), and at least of the test (linearity); (2) The creatinine test must have the one control with one of the compounds (4) The potential for carryover; following calibrators and controls: of interest at a measurable (5) The potential for interfering (i) A calibrator at 2 mg/dL; concentration. Specimens with an substances; and (ii) A control in the range of 1.0 mg/ oxidizing adulterant result equal to or (6) The potential matrix effects if dL to 1.5 mg/dL; greater than the cutoff must be using an alternate technology. (iii) A control in the range of 3 mg/ forwarded to an HHS-certified (b) Each new lot of reagent must be dL to 20 mg/dL; and laboratory. (iv) A control in the range of 21 mg/ verified prior to being placed into Section 12.15 What are the dL to 25 mg/dL. service. requirements for an HHS-certified IITF (c) Each initial drug test using an (b) The requirements for measuring to report a test result? alternate technology must be re-verified specific gravity are as follows: periodically or at least annually. (1) For specimens with creatinine test (a) An HHS-certified IITF must report results greater than 5 mg/dL and less a test result to the agency’s MRO within Section 12.11 What are the batch than 20 mg/dL, an IITF must perform a an average of 3 working days after quality control requirements when screening test using a refractometer to receipt of the specimen. Reports must conducting an initial drug test? identify specific gravity values that are use the Federal CCF and/or an (a) Each batch of specimens must acceptable (equal to or greater electronic report. Before any test result contain the following calibrators and than1.003) or dilute (equal to or greater can be reported, it must be certified by controls: than1.002 and less than1.003). a certifying technician. (1) At least one control certified to Specimens must be forwarded to an (b) A primary (A) specimen is contain no drug or drug metabolite; HHS-certified laboratory when the reported negative when each drug test is (2) At least one positive control with creatinine test result is less than or negative and each specimen validity test the drug or drug metabolite targeted at equal to 5 mg/dL or when the screening result indicates that the specimen is a a concentration 25 percent above the specific gravity test result is less than valid urine specimen. cutoff; 1.002. (c) A primary (A) urine specimen is (3) At least one control with the drug (2) The screening specific gravity test reported dilute when the creatinine or drug metabolite targeted at a must have the following calibrators and concentration is greater than 5 mg/dL concentration 75 percent of the cutoff; controls: but less than 20 mg/dL and the specific and (i) A calibrator or control at 1.000; gravity is equal to or greater than 1.002 (4) At least one control that appears (ii) One control targeted at 1.002; and but less than 1.003. as a donor specimen to the analysts. (iii) One control in the range of 1.004 (d) An HHS-certified IITF shall reject (b) Calibrators and controls must total to 1.018. a urine specimen for testing when a fatal at least 10 percent of the aliquots (c) The requirements for measuring flaw occurs as described in Section 15.1 analyzed in each batch. pH are as follows: or when a correctable flaw as described

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in Section 15.2 is not recovered. The Section 12.20) that supports the chain of the IITF records relating to the drug test HHS-certified IITF will indicate on the custody, testing, and reporting of a results or a documentation package or Federal CCF that the specimen was donor’s specimen that is under legal any relevant certification, review, or rejected for testing and provide the challenge by a donor. The federal revocation of certification records. reason for reporting the rejected for agency’s request to the IITF must be in (b) Standard documentation packages testing result. writing and must specify the period of provided by an HHS-certified IITF must (e) HHS-certified IITFs may transmit time to maintain the documentation contain the following items: test results to the MRO by various package. (1) A cover sheet providing a brief electronic means (e.g., teleprinter, (c) An HHS-certified IITF may retain description of the procedures and tests facsimile, or computer). Transmissions records other than those included in the performed on the donor’s specimen; of the reports must ensure documentation package beyond the (2) A table of contents that lists all confidentiality and the results may not normal two-year period of time. documents and materials in the package be reported verbally by telephone. IITFs by page number; Section 12.19 What statistical and external service providers must (3) A copy of the Federal CCF with summary reports must an HHS-certified ensure the confidentiality, integrity, and any attachments, internal chain of IITF provide? availability of the data and limit access custody records for the specimen, to any data transmission, storage, and (a) HHS-certified IITFs must provide memoranda (if any) generated by the retrieval system. to each federal agency for which they HHS-certified IITF, and a copy of the (f) HHS-certified IITFs must facsimile, perform testing a semiannual statistical electronic report (if any) generated by courier, mail, or electronically transmit summary report that must be submitted the HHS-certified IITF; a legible image or copy of the completed by mail, facsimile, or email within 14 (4) A brief description of the HHS- Federal CCF and/or forward a computer- working days after the end of the certified IITF’s drug and specimen generated electronic report. The semiannual period. The summary report validity testing procedures, computer-generated report must contain must not include any personal instrumentation, and batch quality sufficient information to ensure that the identifying information. A copy of the control requirements; test results can accurately represent the semiannual statistical summary report (5) Copies of all test data for the content of the custody and control form will also be sent to the Secretary or donor’s specimen with all calibrators that the MRO received from the designated HHS representative. The and controls and copies of all internal collector. semiannual statistical report contains chain of custody documents related to (g) For rejected specimens, IITFs must the following information: the tests; and facsimile, courier, mail, or electronically (1) Reporting period (inclusive dates); (6) Copies of the re´sume´ or transmit a legible image or copy of the (2) HHS-certified IITF name and curriculum vitae for the RT and for the completed Federal CCF. address; certifying technician of record. (3) Federal agency name; Section 12.16 How does an HHS- Section 12.21 What HHS-certified IITF (4) Total number of specimens tested; information is available to a federal certified IITF handle a specimen that (5) Number of specimens collected by employee? tested positive, adulterated, substituted, reason for test; or invalid at the IITF? (6) Number of specimens reported A federal employee who is the subject (a) The remaining specimen is negative and the number reported of a drug test may provide a written resealed using a tamper-evident label/ negative/dilute; request through the MRO and/or the seal; (7) Number of specimens rejected for federal agency requesting access to any (b) The individual resealing the testing because of a fatal flaw; records relating to the employee’s drug remaining specimen initials and dates (8) Number of specimens rejected for test results or a documentation package the tamper-evident label/seal; and testing because of an uncorrected flaw; (as described in Section 12.20) and any (c) The resealed specimen and split (9) Number of specimens tested relevant certification, review, or specimen and the Federal CCF are positive by each initial drug test; and revocation of certification records. (10) Number of specimens forwarded sealed in a leak-proof plastic bag, and Section 12.22 What types of to an HHS-certified laboratory for are sent to an HHS-certified laboratory relationships are prohibited between an testing. under chain of custody within one day HHS-certified IITF and an MRO? after completing the drug and specimen (b) An HHS-certified IITF must make validity tests. copies of an agency’s test results An HHS-certified IITF must not enter available when requested to do so by the into any relationship with a federal Section 12.17 How long must an HHS- Secretary or by the federal agency for agency’s MRO that may be construed as certified IITF retain a specimen? which the IITF is performing drug- a potential conflict of interest or derive A specimen that is negative, negative/ testing services. any financial benefit by having a federal dilute, or rejected for testing is (c) An HHS-certified IITF must ensure agency use a specific MRO. discarded. that a qualified individual is available to This means an MRO may be an testify in a proceeding against a federal employee of the agency or a contractor Section 12.18 How long must an HHS- employee when the proceeding is based for the agency; however, an MRO shall certified IITF retain records? on a test result reported by the IITF. not be an employee or agent of or have (a) An HHS-certified IITF must retain any financial interest in the HHS- all records generated to support test Section 12.20 What HHS-certified IITF certified IITF for which the MRO is results for at least 2 years. The IITF may information is available to a federal reviewing drug testing results. convert hardcopy records to electronic agency? Additionally, an MRO shall not derive records for storage and then discard the (a) Following a federal agency’s any financial benefit by having an hardcopy records after six months. receipt of a positive, adulterated, or agency use a specific HHS-certified IITF (b) A federal agency may request the substituted drug test report from a or have any agreement with an HHS- HHS-certified IITF to maintain a laboratory, the federal agency may certified IITF that may be construed as documentation package (as described in submit a written request for copies of a potential conflict of interest.

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Section 12.23 What type of www.samhsa.gov/workplace/drug- (4) Report the verified result to the relationship can exist between an HHS- testing. federal agency. certified IITF and an HHS-certified (e) The MRO must maintain records Section 13.3 What training is required laboratory? for a minimum of two years while before a physician may serve as an maintaining the confidentiality of the An HHS-certified IITF can enter into MRO? information. The MRO may convert any relationship with an HHS-certified (a) A physician must receive training hardcopy records to electronic records laboratory. that includes a thorough review of the for storage and discard the hardcopy Subpart M—Medical Review Officer following: records after six months. (MRO) (1) The collection procedures used to (f) The MRO must conduct a medical collect federal agency specimens; examination or a review of the Section 13.1 Who may serve as an (2) How to interpret test results examining physician’s findings and MRO? reported by HHS-certified IITFs and make a determination of refusal to test (a) A currently licensed physician laboratories (e.g., negative, negative/ or cancelled test when a collector who has: dilute, positive, adulterated, substituted, reports that the donor was unable to rejected for testing, and invalid); (1) A Doctor of Medicine (M.D.) or provide a specimen, as addressed in (3) Chain of custody, reporting, and Section 8.6. Doctor of Osteopathy (D.O.) degree; recordkeeping requirements for federal (2) Knowledge regarding the agency specimens; Section 13.5 What must an MRO do pharmacology and toxicology of illicit (4) The HHS Mandatory Guidelines when reviewing a urine specimen’s test drugs; for Federal Workplace Drug Testing results? (3) The training necessary to serve as Programs for all authorized specimen an MRO as set out in Section 13.3; (a) When the HHS-certified laboratory types; and or HHS-certified IITF reports a negative (4) Satisfactorily passed an initial (5) Procedures for interpretation, result for the primary (A) specimen, the examination administered by a review (e.g., donor interview for MRO reports a negative result to the nationally recognized entity or a legitimate medical explanations, review agency. subspecialty board that has been of documentation provided by the donor (b) When the HHS-certified laboratory approved by the Secretary to certify to support a legitimate medical or HHS-certified IITF reports a negative/ MROs; and explanation), and reporting of results dilute result for the primary (A) urine (5) At least every five years from specified by any federal agency for specimen, the MRO reports a negative/ initial certification, completed which the individual may serve as an dilute result to the agency and directs requalification training on the topics in MRO; the agency to immediately collect (b) Certified MROs must complete Section 13.3 and satisfactorily passed a another specimen from the donor. training on any revisions to these requalification examination (1) If the recollected specimen Guidelines prior to their effective date, administered by a nationally recognized provides a negative or negative/dilute to continue serving as an MRO for entity or a subspecialty board that has result, the MRO reports a negative result federal agency specimens. been approved by the Secretary to to the agency, with no further action certify MROs. Section 13.4 What are the required. Section 13.2 How are nationally responsibilities of an MRO? (2) If the recollected specimen recognized entities or subspecialty (a) The MRO must review all positive, provides a result other than negative or boards that certify MROs approved? adulterated, rejected for testing, invalid, negative/dilute, the MRO follows the procedures in 13.5(c) through (f) for the All nationally recognized entities or and (for urine) substituted test results. (b) Staff under the direct, personal recollected specimen. subspecialty boards which seek supervision of the MRO may review and (c) When the HHS-certified laboratory approval by the Secretary to certify report negative and (for urine) negative/ reports multiple results for the primary physicians as MROs for federal dilute test results to the agency’s (A) urine specimen, as the MRO, you workplace drug testing programs must designated representative. The MRO must follow the verification procedures submit their qualifications, a sample must review at least 5 percent of all described in 13.5(c) through (f) and: examination, and other necessary negative results reported by the MRO (1) Report all verified positive and/or supporting examination materials (e.g., staff to ensure that the MRO staff are refusal to test results to the federal answers, previous examination statistics properly performing the review process. agency. or other background examination (c) The MRO must discuss potential (2) If an invalid result was reported in information, if requested). Approval invalid results with the HHS-certified conjunction with a positive, adulterated, will be based on an objective review of laboratory, as addressed in Section or substituted result, do not report the qualifications that include a copy of the 11.19(g) to determine whether testing at verified invalid result to the federal MRO applicant application form, another HHS-certified laboratory may be agency at this time. The MRO reports documentation that the continuing warranted. the verified invalid result(s) for the education courses are accredited by a (d) After receiving a report from an primary (A) urine specimen only if the professional organization, and the HHS-certified laboratory or (for urine) split specimen is tested and reported as delivery method and content of the HHS-certified IITF, the MRO must: a failure to reconfirm as described in examination. Each approved MRO (1) Review the information on the Section 14.6(l). certification entity must resubmit their MRO copy of the Federal CCF that was (d) When the HHS-certified laboratory qualifications for approval every two received from the collector and the reports a positive result for the primary years. The Secretary shall publish at report received from the HHS-certified (A) specimen, the MRO must contact the least every two years a notice in the laboratory or HHS-certified IITF; donor to determine if there is any Federal Register listing those entities (2) Interview the donor when legitimate medical explanation for the and subspecialty boards that have been required; positive result. approved. This notice is also available (3) Make a determination regarding (1) If the donor provides on the Internet at http:// the test result; and documentation (e.g., a valid

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prescription) to support a legitimate invalid result. In the case of an invalid refusal to test because the specimen was medical explanation for the positive result based on pH of 9.0 to 9.5, when substituted, report only the refusal to result, the MRO reports the test result as an employee has no other medical the federal agency. negative to the agency. If the laboratory explanation for the pH in this range, the (3) If both specimens were verified as also reports that the urine specimen is MRO must consider whether there is positive, adulterated, and/or dilute, the MRO reports a negative/ evidence of elapsed time and high substituted, report all results. For dilute result to the agency and directs temperature that could account for the example, if you verified one specimen the agency to immediately collect pH value. The MRO may contact the as positive and the other as a refusal to another specimen from the donor. The collection site, HHS-certified IITF, and/ test because the specimen was MRO follows the procedures in or HHS-certified laboratory to discuss adulterated, report the positive and the 13.5(b)(1) or (2) for the recollected time and temperature issues (e.g., time refusal results to the federal agency. specimen. elapsed from collection to receipt at the (4) If one specimen has been verified (i) Passive exposure to marijuana testing facility, likely temperature and the HHS-certified laboratory has not smoke is not a legitimate medical conditions between the time of the reported the result(s) of the other explanation for a positive THCA result. collection and transportation to the specimen, (ii) Ingestion of food products testing facility, specimen storage (i) Report verified result(s) of positive, containing marijuana is not a legitimate conditions). adulterated, or substituted immediately medical explanation for a positive (1) If the donor provides a legitimate and do not wait to receive the result(s) THCA result. explanation (e.g., a prescription of the other specimen. (2) If the donor is unable to provide medication) or if the MRO determines (ii) Do not report a verified result of a legitimate medical explanation, the that time and temperature account for negative, negative/dilute, or invalid for MRO reports a positive result to the the pH in the 9.0 to 9.5 range, the MRO the first specimen to the federal agency. agency for all drugs except codeine and/ reports a test cancelled result with the Hold the report until results of both or morphine (see below). If the reason for the invalid result and informs specimens have been received and laboratory also reports that the urine the federal agency that a recollection is verified. specimen is dilute, the MRO may not required because there is a (5) When the HHS-certified laboratory choose not to report the dilute result. legitimate explanation for the invalid reports an invalid result for one or both (i) For codeine and/or morphine less result. specimens, follow the procedures in than 15,000 ng/mL and no legitimate (2) If the donor is unable to provide paragraph c above. medical explanation: the MRO must a legitimate explanation or if the MRO (h) When the HHS-certified laboratory determine if there is clinical evidence of determines that time and temperature or HHS-certified IITF reports a rejected illegal use (in addition to the test result) fail to account for the pH in the 9.0— for testing result for the primary (A) to report a positive result to the agency. 9.5 range, the MRO reports a test specimen, the MRO reports a test If there is no clinical evidence of illegal cancelled result with the reason for the cancelled result to the agency and use, the MRO reports a negative result invalid result and directs the federal recommends that the agency collect to the agency. However, this agency to immediately collect another another specimen from the donor. The requirement does not apply if the urine specimen from the donor using a recollected specimen must be the same laboratory confirms the presence of 6- direct observed collection. type (i.e., urine). (i) If the specimen collected under acetylmorphine (i.e., the presence of Section 13.6 What action does the direct observation provides a valid this metabolite is proof of heroin use). MRO take when the collector reports (ii) For codeine and/or morphine result, the MRO follows the procedures that the donor did not provide a equal to or greater than 15,000 ng/mL in 13.5(a) through (e). sufficient amount of urine for a drug and no legitimate medical explanation: (ii) If the specimen collected under test? the MRO reports a positive result to the direct observation provides an invalid agency. Consumption of food products result, the MRO reports this specimen as (a) When another specimen type (e.g., must not be considered a legitimate test cancelled and recommends that the oral fluid) was collected as authorized medical explanation for the donor agency collect another authorized by the federal agency, the MRO reviews having morphine or codeine at or above specimen type (e.g., oral fluid). and reports the test result in accordance this concentration. (g) When two separate specimens with the Mandatory Guidelines for (e) When the HHS-certified laboratory collected during the same testing event Federal Workplace Drug Testing reports an adulterated or substituted were sent to the HHS-certified Programs using the alternative result for the primary (A) urine laboratory for testing (e.g., the collector specimen. specimen, the MRO contacts the donor sent a urine specimen out of (b) When the federal agency did not to determine if the donor has a temperature range and the subsequently authorize the collection of an alternative legitimate medical explanation for the collected specimen—urine or another specimen, the MRO consults with the adulterated or substituted result. authorized specimen type), as the MRO, federal agency. The federal agency (1) If the donor provides a legitimate you must follow the verification immediately directs the donor to obtain, medical explanation, the MRO reports a procedures described in Sections 13.4, within five days, an evaluation from a negative result to the federal agency. 13.5, and 13.6, and: licensed physician, acceptable to the (2) If the donor is unable to provide (1) If both specimens were verified MRO, who has expertise in the medical a legitimate explanation, the MRO negative, report the result as negative. issues raised by the donor’s failure to reports a refusal to test to the federal (2) If one specimen was verified provide a specimen. The MRO may agency because the urine specimen was negative and the other was not (i.e., the perform this evaluation if the MRO has adulterated or substituted. specimen was verified as negative/ appropriate expertise. (f) When the HHS-certified laboratory dilute or as positive, adulterated, (1) For purposes of this section, a reports an invalid result for the primary substituted, and/or invalid), report only medical condition includes an (A) urine specimen, the MRO must the verified result(s) other than negative. ascertainable physiological condition contact the donor to determine if there For example, if you verified one (e.g., a urinary system dysfunction) or a is a legitimate explanation for the specimen as negative and the other as a medically documented pre-existing

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psychological disorder, but does not amount of urine and is highly likely to that one is conducted by a licensed include unsupported assertions of prevent the employee from providing a physician acceptable to you. ‘‘situational anxiety’’ or dehydration. sufficient amount of urine for a very (b) If the medical evaluation reveals Permanent or long-term medical long or indefinite period of time. As the no clinical evidence of drug use, as the conditions are those physiological, MRO, you must follow the requirements MRO, you must report the result to the anatomic, or psychological of Section 13.7, as appropriate. If federal agency as a negative test with abnormalities documented as being Section 13.7 is not applicable, you written notations regarding results of present prior to the attempted report a test cancelled result to the both the evaluation conducted under collection, and considered not amenable federal agency and recommend that the Section 13.6 and any further medical to correction or cure for an extended agency authorize collection of an examination. This report must state the period of time. Examples would include alternative specimen type (e.g., oral basis for the determination that a destruction (any cause) of the fluid) for any subsequent drug tests for permanent or long-term medical glomerular filtration system leading to the donor. condition exists, making provision of a renal failure; unrepaired traumatic (iii) There is not an adequate basis for disruption of the urinary tract; or a sufficient urine specimen impossible, determining that a medical condition and for the determination that no signs severe psychiatric disorder focused on has, or with a high degree of probability genitourinary matters. Acute or and symptoms of drug use exist. The could have, precluded the employee MRO recommends that the agency temporary medical conditions, such as from providing a sufficient amount of authorize collection of an alternate cystitis, urethritis or prostatitis, though urine. As the MRO, you must report a specimen type (e.g., oral fluid) for any they might interfere with collection for refusal to test to the federal agency. subsequent collections. a limited period of time, cannot receive (4) When a federal agency receives a the same exceptional consideration as report from the MRO indicating that a (c) If the medical evaluation reveals the permanent or long-term conditions test is cancelled as provided in clinical evidence of drug use, as the discussed in the previous sentence. paragraph (b)(3)(i) of this section, the MRO, you must report the result to the (2) As the MRO, if another physician agency takes no further action with federal agency as a cancelled test with will perform the evaluation, you must respect to the donor. When a test is written notations regarding results of provide the other physician with the canceled as provided in paragraph both the evaluation conducted under following information and instructions: (b)(3)(ii) of this section, the agency takes Section 13.6 and any further medical (i) That the donor was required to take no further action with respect to the examination. This report must state that a federally regulated drug test, but was donor other than designating collection a permanent or long-term medical unable to provide a sufficient amount of of an alternate specimen type (i.e., condition [as defined in Section urine to complete the test; 13.6(b)(1)] exists, making provision of a (ii) The consequences of the authorized by the Mandatory Guidelines for Federal Workplace Drug Testing sufficient urine specimen impossible, appropriate federal agency regulation and state the reason for the for refusing to take the required drug Programs) for any subsequent determination that signs and symptoms test; collections, in accordance with the of drug use exist. Because this is a (iii) That, after completing the federal agency plan. The donor remains evaluation, the referral physician must in the random testing pool. cancelled test, it does not serve the purposes of a negative test (e.g., the agree to provide a written statement to 13.7 What happens when an the MRO with a recommendation for federal agency is not authorized to allow individual is unable to provide a the donor to begin or resume performing one of the determinations described in sufficient amount of urine for a federal paragraph (b)(3) of this section and the official functions, because a negative agency applicant/pre-employment test, test is needed for that purpose). basis for the recommendation. The a follow-up test, or a return-to-duty test statement must not include detailed because of a permanent or long-term Section 13.8 Who may request a test of information on the employee’s medical medical condition? a split (B) specimen? condition beyond what is necessary to explain the referral physician’s (a) This section concerns a situation (a) For a positive, adulterated, or conclusion. in which the donor has a medical substituted result reported on a primary (3) As the MRO, if another physician condition that precludes the donor from (A) specimen, a donor may request performed the evaluation, you must providing a sufficient specimen for a through the MRO that the split (B) consider and assess the referral federal agency applicant/pre- specimen be tested by a second HHS- physician’s recommendations in making employment test, a follow-up test, or a certified laboratory to verify the result your determination. You must make one return-to-duty test and the condition reported by the first HHS-certified of the following determinations and involves a permanent or long-term laboratory. disability and the federal agency does report it to the federal agency in writing: (b) The donor has 72 hours (from the (i) A medical condition as defined in not authorize collection of an alternative time the MRO notified the donor that paragraph (b)(1) of this section has, or specimen. As the MRO in this situation, the donor’s specimen was reported with a high degree of probability could you must do the following: positive, adulterated, or (for urine) have, precluded the employee from (1) You must determine if there is substituted to request a test of the split providing a sufficient amount of urine, clinical evidence that the individual is (B) specimen. The MRO must inform the but is not a permanent or long-term an illicit drug user. You must make this donor that the donor has the disability. As the MRO, you must report determination by personally opportunity to request a test of the split a test cancelled result to the federal conducting, or causing to be conducted, (B) specimen when the MRO informs agency. a medical evaluation and through (ii) A permanent or long-term medical consultation with the donor’s physician the donor that a positive, adulterated, or condition as defined in paragraph (b)(1) and/or the physician who conducted the (for urine) substituted result is being of this section has, or with a high degree evaluation under Section 13.6. reported to the federal agency on the of probability could have, precluded the (2) If you do not personally conduct primary (A) specimen. employee from providing a sufficient the medical evaluation, you must ensure

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Section 13.9 How does an MRO report lost in transit, split not available, no dodecylbenzene sulfonate-equivalent a primary (A) specimen test result to an second HHS-certified laboratory cutoff; or agency? available to perform the test), the MRO (4) For adulterants without a specified (a) The MRO must report all verified reports to the federal agency that the test cutoff (e.g., glutaraldehyde, chromium results to an agency using the completed must be cancelled and the reason for the (VI), pyridine, halogens (such as, bleach, MRO copy of the Federal CCF or a cancellation. The MRO directs the iodine), peroxidase, peroxide, other separate report using a letter/ federal agency to ensure the immediate oxidizing agents), the laboratory must memorandum format. The MRO may recollection of another urine specimen use its confirmatory specimen validity use various electronic means for from the donor under direct test at an established limit of reporting (e.g., teleprinter, facsimile, or observation, with no notice given to the quantification (LOQ) to reconfirm the computer). Transmissions of the reports donor of this collection requirement presence of the adulterant. (b) The second HHS-certified must ensure confidentiality. The MRO until immediately before the collection. laboratory may only conduct the and external service providers must (d) If a donor chooses not to have the confirmatory specimen validity test(s) ensure the confidentiality, integrity, and split (B) specimen tested by a second needed to reconfirm the adulterated availability of the data and limit access HHS-certified laboratory, a federal result reported by the first HHS-certified to any data transmission, storage, and agency may have a split (B) specimen laboratory. retrieval system. retested as part of a legal or administrative proceeding to defend an (b) A verified result may not be Section 14.4 How does an HHS- original positive, adulterated, or (for reported to the agency until the MRO certified laboratory test a split (B) urine urine) substituted result. has completed the review process. specimen when the primary (A) (c) The MRO must send a copy of Section 14.2 How does an HHS- specimen was reported substituted? either the completed MRO copy of the certified laboratory test a split (B) (a) An HHS-certified laboratory must Federal CCF or the separate letter/ specimen when the primary (A) use the following criteria to reconfirm a memorandum report for all positive, specimen was reported positive? substituted result when testing a split adulterated, and (for urine) substituted (a) The testing of a split (B) specimen (B) urine specimen: results. (1) The creatinine must be measured (d) The MRO must not disclose for a drug or metabolite is not subject to using the laboratory’s confirmatory numerical values of drug test results to the testing cutoff concentrations creatinine test with a cutoff the agency. established. (b) The HHS-certified laboratory is concentration of less than 2 mg/dL; and Section 13.10 What types of only required to confirm the presence of (2) The specific gravity must be relationships are prohibited between an the drug or metabolite that was reported measured using the laboratory’s MRO and an HHS-certified laboratory or positive in the primary (A) specimen. confirmatory specific gravity test with an HHS-certified IITF? (c) For a split (B) urine specimen, if the specified cutoffs of less than or An MRO must not be an employee, the second HHS-certified laboratory equal to 1.0010 or equal to or greater agent of, or have any financial interest fails to reconfirm the presence of the than 1.0200. in an HHS-certified laboratory or an drug or drug metabolite that was (b) The second HHS-certified HHS-certified IITF for which the MRO reported by the first HHS-certified laboratory may only conduct the is reviewing drug test results. laboratory, the second laboratory must confirmatory specimen validity test(s) This means an MRO must not derive conduct specimen validity tests in an needed to reconfirm the substituted any financial benefit by having an attempt to determine the reason for result reported by the first HHS-certified agency use a specific HHS-certified being unable to reconfirm the presence laboratory. of the drug or drug metabolite. The laboratory or HHS-certified IITF, or have Section 14.5 Who receives the split (B) second laboratory should conduct the any agreement with the HHS-certified specimen result? laboratory or the HHS-certified IITF that same specimen validity tests as it would The second HHS-certified laboratory may be construed as a potential conflict conduct on a primary (A) urine must report the result to the MRO. of interest. specimen and reports those results to the MRO. Section 14.6 What action(s) does an Subpart N—Split Specimen Tests Section 14.3 How does an HHS- MRO take after receiving the split (B) Section 14.1 When may a split (B) certified laboratory test a split (B) urine urine specimen result from the second specimen be tested? specimen when the primary (A) HHS-certified laboratory? (a) The donor may request, verbally or specimen was reported adulterated? The MRO takes the following actions in writing, through the MRO that the (a) An HHS-certified laboratory must when the second HHS-certified split (B) specimen be tested at a use one of the following criteria to laboratory reports the result for the split different (i.e., second) HHS-certified reconfirm an adulterated result when (B) urine specimen as: laboratory when the primary (A) testing a split (B) urine specimen: (a) Reconfirmed the drug(s), specimen was determined by the MRO (1) pH must be measured using the adulteration, and/or substitution result. to be positive, adulterated, or (for urine) laboratory’s confirmatory pH test with The MRO reports reconfirmed to the substituted. the appropriate cutoff (i.e., either less agency. (b) A donor has 72 hours to initiate than 4 or equal to or greater than 11); (b) Failed to reconfirm a single or all the request after being informed of the (2) Nitrite must be measured using the drug positive results and adulterated. If result by the MRO. The MRO must laboratory’s confirmatory nitrite test the donor provides a legitimate medical document in the MRO’s records the with a cutoff concentration of equal to explanation for the adulteration result, verbal request from the donor to have or greater than 500 mcg/mL; the MRO reports a failed to reconfirm the split (B) specimen tested. (3) Surfactant must be measured using [specify drug(s)] and cancels both tests. (c) If a split (B) urine specimen cannot the laboratory’s confirmatory surfactant If there is no legitimate medical be tested by a second HHS-certified test with a cutoff concentration of equal explanation, the MRO reports a failed to laboratory (e.g., insufficient specimen, to or greater than 100 mcg/mL reconfirm [specify drug(s)] and a refusal

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to test to the agency and indicates the drug(s)] and a failed to reconfirm result substituted) and a failed to reconfirm adulterant that is present in the [specify drug(s)]. The MRO tells the result [specify drug(s)]. The MRO tells specimen. The MRO gives the donor 72 agency that it may take action based on the agency that it may take action based hours to request that Laboratory A retest the reconfirmed drug(s) although on the reconfirmed result (adulterated the primary (A) specimen for the Laboratory B failed to reconfirm one or or substituted) although Laboratory B adulterant. If Laboratory A reconfirms more drugs and found that the specimen failed to reconfirm the drug(s) result. the adulterant, the MRO reports refusal was adulterated. The MRO shall notify (l) Failed to reconfirm a single or all to test and indicates the adulterant the HHS office responsible for drug positive results and failed to present. If Laboratory A fails to coordination of the drug-free workplace reconfirm the adulterated or substituted reconfirm the adulterant, the MRO program regarding the test results for the result. The MRO reports to the agency cancels both tests and directs the agency specimen. a failed to reconfirm result [specify to immediately collect another (g) Failed to reconfirm one or more drug(s) and specify adulterant or specimen using a direct observed drugs, reconfirmed one or more drugs, substituted] and cancels both tests. The collection procedure. The MRO shall and substituted. The MRO reports to the MRO shall notify the HHS office notify the appropriate regulatory office agency a reconfirmed result [specify responsible for coordination of the drug- about the failed to reconfirm and drug(s)] and a failed to reconfirm result free workplace program regarding the cancelled test. [(specify drug(s)]). The MRO tells the test results for the specimen. (c) Failed to reconfirm a single or all agency that it may take action based on (m) Failed to reconfirm at least one drug positive results and substituted. If the reconfirmed drug(s) although drug and reconfirmed the adulterated the donor provides a legitimate medical Laboratory B failed to reconfirm one or result. The MRO reports to the agency explanation for the substituted result, more drugs and found that the specimen a reconfirmed result [(specify drug(s) the MRO reports a failed to reconfirm was substituted. The MRO shall notify and adulterated] and a failed to [specify drug(s)] and cancels both tests. the HHS office responsible for reconfirm result [specify drug(s)]. The If there is no legitimate medical coordination of the drug-free workplace MRO tells the agency that it may take explanation, the MRO reports a failed to program regarding the test results for the action based on the reconfirmed drug(s) reconfirm [specify drug(s)] and a refusal specimen. and the adulterated result although to test (substituted) to the agency. The (h) Failed to reconfirm one or more Laboratory B failed to reconfirm one or MRO gives the donor 72 hours to drugs, reconfirmed one or more drugs, more drugs. request Laboratory A to review the and not adulterated or substituted. The (n) Failed to reconfirm at least one creatinine and specific gravity results MRO reports a reconfirmed result drug and failed to reconfirm the for the primary (A) specimen. If the [specify drug(s)] and a failed to adulterated result. The MRO reports to original creatinine and specific gravity reconfirm result [specify drug(s)]. The the agency a reconfirmed result [specify results confirm that the specimen was MRO tells the agency that it may take drug(s)] and a failed to reconfirm result substituted, the MRO reports a refusal to action based on the reconfirmed drug(s) [specify drug(s) and specify adulterant]. test (substituted) to the agency. If the although Laboratory B failed to The MRO tells the agency that it may original creatinine and specific gravity reconfirm one or more drugs. The MRO take action based on the reconfirmed results from Laboratory A fail to confirm shall notify the HHS office responsible drug(s) although Laboratory B failed to that the specimen was substituted, the for coordination of the drug-free reconfirm one or more drugs and failed MRO cancels both tests and directs the workplace program regarding the test to reconfirm the adulterated result. agency to immediately collect another results for the specimen. (o) Failed to reconfirm an adulterated specimen using a direct observed (i) Failed to reconfirm one or more result and failed to reconfirm a collection procedure. The MRO shall drugs, reconfirmed one or more drugs, substituted result. The MRO reports to notify the HHS office responsible for and invalid result. The MRO reports to the agency a failed to reconfirm result coordination of the drug-free workplace the agency a reconfirmed result [specify [(specify adulterant) and not program about the failed to reconfirm drug(s)] and a failed to reconfirm result substituted] and cancels both tests. The and cancelled test. [specify drug(s)]. The MRO tells the MRO shall notify the HHS office (d) Failed to reconfirm a single or all agency that it may take action based on responsible for coordination of the drug- drug positive results and not the reconfirmed drug(s) although free workplace program regarding the adulterated or substituted. The MRO Laboratory B failed to reconfirm one or test results for the specimen. reports to the agency a failed to more drugs and reported an invalid (p) Failed to reconfirm an adulterated reconfirm result [specify drug(s)], result. The MRO shall notify the HHS result and reconfirmed a substituted cancels both tests, and notifies the HHS office responsible for coordination of result. The MRO reports to the agency office responsible for coordination of the drug-free workplace program a reconfirmed result (substituted) and a the drug-free workplace program. regarding the test results for the failed to reconfirm result (specify (e) Failed to reconfirm a single or all specimen. adulterant). The MRO tells the agency drug positive results and invalid result. (j) Failed to reconfirm substitution or that it may take action based on the The MRO reports to the agency a failed adulteration. The MRO reports to the substituted result although Laboratory B to reconfirm result [specify drug(s) and agency a failed to reconfirm result failed to reconfirm the adulterated give the reason for the invalid result], (specify adulterant or not substituted) result. cancels both tests, directs the agency to and cancels both tests. The MRO shall (q) Failed to reconfirm a substituted immediately collect another specimen notify the HHS office responsible for result and reconfirmed an adulterated using a direct observed collection coordination of the drug-free workplace result. The MRO reports to the agency procedure, and notifies the HHS office program regarding the test results for the a reconfirmed result (adulterated) and a responsible for coordination of the drug- specimen. failed to reconfirm result (not free workplace program. (k) Failed to reconfirm a single or all substituted). The MRO tells the agency (f) Failed to reconfirm one or more drug positive results and reconfirmed an that it may take action based on the drugs, reconfirmed one or more drugs, adulterated or substituted result. The adulterated result although Laboratory B and adulterated. The MRO reports to MRO reports to the agency a failed to reconfirm the substituted the agency a reconfirmed result [(specify reconfirmed result (adulterated or result.

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Section 14.7 How does an MRO report (c) The collector’s printed name and Section 15.3 What discrepancies are a split (B) specimen test result to an signature are omitted on the Federal not sufficient to require an HHS- agency? CCF; certified laboratory or an HHS-certified (a) The MRO must report all verified (d) There is an insufficient amount of IITF to reject a urine specimen for results to an agency using the completed specimen for analysis in the primary (A) testing or an MRO to cancel a test? MRO copy of the Federal CCF or a specimen unless the split (B) specimen (a) The following omissions and separate report using a letter/ can be re-designated as the primary (A) discrepancies on the Federal CCF that memorandum format. The MRO may specimen; are received by the HHS-certified (e) The accessioner failed to use various electronic means for laboratory or IITF should not cause an document the primary (A) specimen reporting (e.g., teleprinter, facsimile, or HHS-certified laboratory or IITF to reject seal condition on the Federal CCF at the computer). Transmissions of the reports a urine specimen or cause an MRO to time of accessioning, and the split (B) must ensure confidentiality. The MRO cancel a test: specimen cannot be re-designated as the and external service providers must (1) An incorrect laboratory name and primary (A) specimen; address appearing at the top of the form; ensure the confidentiality, integrity, and (f) The specimen was received at the (2) Incomplete/incorrect/unreadable availability of the data and limit access HHS-certified laboratory or IITF without employer name or address; to any data transmission, storage, and a CCF; retrieval system. (3) MRO name is missing; (g) The CCF was received at the HHS- (4) Incomplete/incorrect MRO (b) A verified result may not be certified laboratory or IITF without a reported to the agency until the MRO address; specimen; (5) A transposition of numbers in the has completed the review process. (h) The collector performed two (c) The MRO must send a copy of donor’s Social Security Number or separate collections using one CCF; or employee identification number; either the completed MRO copy of the (i) The HHS-certified laboratory or (6) A telephone number is missing/ Federal CCF or the separate letter/ IITF identifies a flaw (other than those incorrect; memorandum report for all split specified above) that prevents testing or specimen results. (7) A fax number is missing/incorrect; affects the forensic defensibility of the (8) A ‘‘reason for test’’ box is not (d) The MRO must not disclose the drug test and cannot be corrected. numerical values of the drug test results marked; to the agency. Section 15.2 What discrepancies (9) A ‘‘drug tests to be performed’’ box require an HHS-certified laboratory or is not marked; Section 14.8 How long must an HHS- an HHS-certified IITF to report a (10) A ‘‘specimen collection’’ box is certified laboratory retain a split (B) specimen as rejected for testing unless not marked; specimen? the discrepancy is corrected? (11) The ‘‘observed’’ box is not marked (if applicable); A split (B) specimen is retained for The following discrepancies are the same period of time that a primary (12) The collection site address is considered to be correctable: missing; (A) specimen is retained and under the (a) If a collector failed to sign the same storage conditions. This applies (13) The collector’s printed name is Federal CCF, the HHS-certified missing but the collector’s signature is even for those cases when the split (B) laboratory or IITF must attempt to specimen is tested by a second HHS- properly recorded; recover the collector’s signature before (14) The time of collection is not certified laboratory and the second reporting the test result. If the collector indicated; HHS-certified laboratory does not can provide a memorandum for record (15) The date of collection is not confirm the original result reported by recovering the signature, the HHS- indicated; the first HHS-certified laboratory for the certified laboratory or IITF may report (16) Incorrect name of delivery primary (A) specimen. the test result for the specimen. If, after service; Subpart O—Criteria for Rejecting a holding the specimen for at least 5 (17) The collector has changed or Specimen for Testing business days, the HHS-certified corrected information by crossing out laboratory or IITF cannot recover the the original information on either the Section 15.1 What discrepancies collector’s signature, the laboratory or Federal CCF or specimen label/seal require an HHS-certified laboratory or IITF must report a rejected for testing without dating and initialing the an HHS-certified IITF to report a result and indicate the reason for the change; or specimen as rejected for testing? rejected for testing result on the Federal (18) The donor’s name inadvertently The following discrepancies are CCF. appears on the HHS-certified laboratory considered to be fatal flaws. The HHS- (b) If a specimen is submitted using a or IITF copy of the Federal CCF or on certified laboratory or IITF must stop non-federal form or an expired Federal the tamper-evident labels used to seal the testing process, reject the specimen CCF, the HHS-certified laboratory or the specimens. for testing, and indicate the reason for IITF must test the specimen and also (19) The collector failed to check the rejecting the specimen on the Federal attempt to obtain a memorandum for specimen temperature box and the CCF when: record explaining why a non-federal ‘‘Remarks’’ line did not have a comment (a) The specimen ID number on the form or an expired Federal CCF was regarding the temperature being out of primary (A) or split (B) specimen label/ used and ensure that the form used range. If, after at least 5 business days, seal does not match the ID number on contains all the required information. If, the collector cannot provide a the Federal CCF, or the ID number is after holding the specimen for at least 5 memorandum for record to attest to the missing either on the Federal CCF or on business days, the HHS-certified fact that the collector did measure the either specimen label/seal; laboratory or IITF cannot obtain a specimen temperature, the HHS- (b) The primary (A) specimen label/ memorandum for record from the certified laboratory or IITF may report seal is missing, misapplied, broken, or collector, the laboratory or IITF must the test result for the specimen but shows evidence of tampering and the report a rejected for testing result and indicates that the collector could not split (B) specimen cannot be re- indicate the reason for the rejected for provide a memorandum to recover the designated as the primary (A) specimen; testing result on the report to the MRO. omission.

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(b) The following omissions and CCF, but did, in fact, properly conduct not be subject to review under these discrepancies on the Federal CCF that the certification review. If, after at least procedures. are made at the HHS-certified laboratory 5 business days, the MRO cannot get a or IITF should not cause an MRO to statement from the certifying scientist, Section 16.4 Who represents the cancel a test: the MRO must cancel the test. parties? (1) The testing laboratory or IITF fails (d) If error (a)(3) occurs, the MRO The appellant’s request for review to indicate the correct name and address must contact the HHS-certified shall specify the name, address, and in the results section when a different laboratory or HHS-certified IITF. If, after telephone number of the appellant’s laboratory or IITF name and address is at least 5 business days, the laboratory representative. In its first written printed at the top of the Federal CCF; or IITF does not retransmit a corrected submission to the reviewing official, the (2) The accessioner fails to print their electronic report, the MRO must cancel name; the test. respondent shall specify the name, (3) The certifying scientist or address, and telephone number of the certifying technician fails to print their Subpart P—Laboratory or IITF respondent’s representative. Suspension/Revocation Procedures name; Section 16.5 When must a request for (4) The certifying scientist or Section 16.1 When may the HHS informal review be submitted? certifying technician accidentally certification of a laboratory or IITF be initials the Federal CCF rather than suspended? (a) Within 30 days of the date of the signing for a specimen reported as These procedures apply when: notice of the suspension or proposed rejected for testing; revocation, the appellant must submit a (c) The above omissions and (a) The Secretary has notified an HHS- written request to the reviewing official discrepancies should occur no more certified laboratory or IITF in writing seeking review, unless some other time than once a month. The expectation is that its certification to perform drug period is agreed to by the parties. A that each trained collector and HHS- testing under these Guidelines has been certified laboratory or IITF will make suspended or that the Secretary copy must also be sent to the every effort to ensure that the Federal proposes to revoke such certification. respondent. The request for review must CCF is properly completed and that all (b) The HHS-certified laboratory or include a copy of the notice of the information is correct. When an IITF has, within 30 days of the date of suspension or proposed revocation, a error occurs more than once a month, such notification or within 3 days of the brief statement of why the decision to the MRO must direct the collector, HHS- date of such notification when seeking suspend or propose revocation is wrong, certified laboratory, or HHS-certified an expedited review of a suspension, and the appellant’s request for an oral IITF (whichever is responsible for the requested in writing an opportunity for presentation, if desired. error) to immediately take corrective an informal review of the suspension or (b) Within 5 days after receiving the proposed revocation. action to prevent the recurrence of the request for review, the reviewing official error. Section 16.2 What definitions are used will send an acknowledgment and Section 15.4 What discrepancies may for this subpart? advise the appellant of the next steps. require an MRO to cancel a test? Appellant. Means the HHS-certified The reviewing official will also send a copy of the acknowledgment to the (a) An MRO must attempt to correct laboratory or IITF which has been the following errors: notified of its suspension or proposed respondent. (1) The donor’s signature is missing revocation of its certification to perform Section 16.6 What is an abeyance on the MRO copy of the Federal CCF testing and has requested an informal agreement? and the collector failed to provide a review thereof. comment that the donor refused to sign Respondent. Means the person or Upon mutual agreement of the parties the form; persons designated by the Secretary in to hold these procedures in abeyance, (2) The certifying scientist failed to implementing these Guidelines. the reviewing official will stay these sign the Federal CCF for a specimen Reviewing Official. Means the person procedures for a reasonable time while being reported drug positive, or persons designated by the Secretary the laboratory or IITF attempts to regain adulterated, invalid, or (for urine) who will review the suspension or compliance with the Guidelines or the substituted; or proposed revocation. The reviewing parties otherwise attempt to settle the (3) The electronic report provided by official may be assisted by one or more dispute. As part of an abeyance the HHS-certified laboratory or HHS- of the official’s employees or agreement, the parties can agree to consultants in assessing and weighing certified IITF does not contain all the extend the time period for requesting data elements required for the HHS the scientific and technical evidence review of the suspension or proposed standard laboratory or IITF electronic and other information submitted by the revocation. If abeyance begins after a report for a specimen being reported appellant and respondent on the reasons request for review has been filed, the drug positive, adulterated, invalid for the suspension and proposed result, or (for urine) substituted. revocation. appellant shall notify the reviewing (b) If error (a)(1) occurs, the MRO official at the end of the abeyance Section 16.3 Are there any limitations must contact the collector to obtain a period advising whether the dispute has on issues subject to review? statement to verify that the donor been resolved. If the dispute has been refused to sign the MRO copy. If, after The scope of review shall be limited resolved, the request for review will be at least 5 business days, the collector to the facts relevant to any suspension dismissed. If the dispute has not been cannot provide such a statement, the or proposed revocation, the necessary resolved, the review procedures will MRO must cancel the test. interpretations of those facts, the begin at the point at which they were (c) If error (a)(2) occurs, the MRO relevant Mandatory Guidelines for interrupted by the abeyance agreement must obtain a statement from the Federal Workplace Drug Testing with such modifications to the certifying scientist that they Programs, and other relevant law. The procedures as the reviewing official inadvertently forgot to sign the Federal legal validity of these Guidelines shall deems appropriate.

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Section 16.7 What procedures are used Section 16.8 When is there an has a responsibility to respond to the to prepare the review file and written opportunity for oral presentation? respondent’s allegations with evidence argument? (a) Electing Oral Presentation. If an and argument to show that the opportunity for an oral presentation is respondent is wrong. The appellant and the respondent (3) Admission of Evidence. The desired, the appellant shall request it at each participate in developing the file Federal Rules of Evidence do not apply the time it submits its written request for the reviewing official and in and the presiding official will generally for review to the reviewing official. The submitting written arguments. The admit all testimonial evidence unless it reviewing official will grant the request procedures for development of the is clearly irrelevant, immaterial, or if the official determines that the review file and submission of written unduly repetitious. Each party may decision-making process will be argument are: make an opening and closing statement, substantially aided by oral presentations may present witnesses as agreed upon (a) Appellant’s Documents and Brief. and arguments. The reviewing official Within 15 days after receiving the in the prehearing conference or may also provide for an oral otherwise, and may question the acknowledgment of the request for presentation at the official’s own review, the appellant shall submit to the opposing party’s witnesses. Since the initiative or at the request of the parties have ample opportunity to reviewing official the following (with a respondent. copy to the respondent): prepare the review file, a party may (b) Presiding Official. The reviewing introduce additional documentation (1) A review file containing the official or designee will be the presiding during the oral presentation only with documents supporting appellant’s official responsible for conducting the the permission of the presiding official. argument, tabbed and organized oral presentation. The presiding official may question chronologically, and accompanied by an (c) Preliminary Conference. The witnesses directly and take such other index identifying each document. Only presiding official may hold a prehearing steps necessary to ensure an effective essential documents should be conference (usually a telephone and efficient consideration of the submitted to the reviewing official. conference call) to consider any of the evidence, including setting time (2) A written statement, not to exceed following: Simplifying and clarifying limitations on direct and cross- 20 double-spaced pages, explaining why issues, stipulations and admissions, examinations. respondent’s decision to suspend or limitations on evidence and witnesses (4) Motions. The presiding official propose revocation of appellant’s that will be presented at the hearing, may rule on motions including, for certification is wrong (appellant’s brief). time allotted for each witness and the example, motions to exclude or strike hearing altogether, scheduling the (b) Respondent’s Documents and redundant or immaterial evidence, hearing, and any other matter that will Brief. Within 15 days after receiving a motions to dismiss the case for assist in the review process. Normally, copy of the acknowledgment of the insufficient evidence, or motions for this conference will be conducted request for review, the respondent shall summary judgment. Except for those informally and off the record; however, submit to the reviewing official the made during the hearing, all motions the presiding official may, at their following (with a copy to the appellant): and opposition to motions, including discretion, produce a written document argument, must be in writing and be no (1) A review file containing summarizing the conference or more than 10 double-spaced pages in documents supporting respondent’s transcribe the conference, either of length. The presiding official will set a decision to suspend or revoke which will be made a part of the record. reasonable time for the party opposing appellant’s certification to perform drug (d) Time and Place of the Oral the motion to reply. testing, which is tabbed and organized Presentation. The presiding official will (5) Transcripts. The presiding official chronologically, and accompanied by an attempt to schedule the oral shall have the oral presentation index identifying each document. Only presentation within 30 days of the date transcribed and the transcript shall be essential documents should be the appellant’s request for review is made a part of the record. Either party submitted to the reviewing official. received or within 10 days of may request a copy of the transcript and (2) A written statement, not exceeding submission of the last reply brief, the requesting party shall be responsible 20 double-spaced pages in length, whichever is later. The oral presentation for paying for its copy of the transcript. explaining the basis for suspension or will be held at a time and place (f) Obstruction of Justice or Making of proposed revocation (respondent’s determined by the presiding official False Statements. Obstruction of justice brief). following consultation with the parties. or the making of false statements by a (c) Reply Briefs. Within 5 days after (e) Conduct of the Oral Presentation. witness or any other person may be the receiving the opposing party’s (1) General. The presiding official is basis for a criminal prosecution under submission, or 20 days after receiving responsible for conducting the oral 18 U.S.C. 1505 or 1001. acknowledgment of the request for presentation. The presiding official may (g) Post-hearing Procedures. At their review, whichever is later, each party be assisted by one or more of the discretion, the presiding official may may submit a short reply not to exceed official’s employees or consultants in require or permit the parties to submit 10 double-spaced pages. conducting the oral presentation and post-hearing briefs or proposed findings reviewing the evidence. While the oral and conclusions. Each party may submit (d) Cooperative Efforts. Whenever presentation will be kept as informal as comments on any major prejudicial feasible, the parties should attempt to possible, the presiding official may take errors in the transcript. develop a joint review file. all necessary steps to ensure an orderly (e) Excessive Documentation. The proceeding. Section 16.9 Are there expedited reviewing official may take any (2) Burden of Proof/Standard of Proof. procedures for review of immediate appropriate step to reduce excessive In all cases, the respondent bears the suspension? documentation, including the return of burden of proving by a preponderance (a) Applicability. When the Secretary or refusal to consider documentation of the evidence that its decision to notifies an HHS-certified laboratory or found to be irrelevant, redundant, or suspend or propose revocation is IITF in writing that its certification to unnecessary. appropriate. The appellant, however, perform drug testing has been

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immediately suspended, the appellant communications between the parties Section 16.13 What administrative may request an expedited review of the and between either party and the records are maintained? suspension and any proposed reviewing official shall be by facsimile, The administrative record of review revocation. The appellant must submit secured electronic transmissions, or consists of the review file; other this request in writing to the reviewing overnight mail. submissions by the parties; transcripts official within 3 days of the date the or other records of any meetings, HHS-certified laboratory or IITF Section 16.10 Are any types of communications prohibited? conference calls, or oral presentation; received notice of the suspension. The evidence submitted at the oral request for review must include a copy Except for routine administrative and presentation; and orders and other of the suspension and any proposed procedural matters, a party shall not documents issued by the reviewing and revocation, a brief statement of why the communicate with the reviewing or presiding officials. decision to suspend and propose presiding official without notice to the Section 16.14 What are the revocation is wrong, and the appellant’s other party. request for an oral presentation, if requirements for a written decision? desired. A copy of the request for review Section 16.11 How are (a) Issuance of Decision. The must also be sent to the respondent. communications transmitted by the reviewing official shall issue a written (b) Reviewing Official’s Response. As reviewing official? decision upholding or denying the soon as practicable after the request for suspension or proposed revocation. The review is received, the reviewing official (a) Because of the importance of a timely review, the reviewing official decision will set forth the reasons for will send an acknowledgment with a the decision and describe the basis copy to the respondent. should normally transmit written communications to either party by therefore in the record. Furthermore, the (c) Review File and Briefs. Within 7 reviewing official may remand the days of the date the request for review facsimile, secured electronic transmissions, or overnight mail in matter to the respondent for such is received, but no later than 2 days further action as the reviewing official which case the date of transmission or before an oral presentation, each party deems appropriate. shall submit to the reviewing official the day following mailing will be (b) Date of Decision. The reviewing following: considered the date of receipt. In the official will attempt to issue their (1) A review file containing essential case of communications sent by regular decision within 15 days of the date of documents relevant to the review, mail, the date of receipt will be the oral presentation, the date on which which is tabbed, indexed, and organized considered 3 days after the date of the transcript is received, or the date of chronologically; and mailing. the last submission by either party, (2) A written statement, not to exceed (b) In counting days, include 20 double-spaced pages, explaining the whichever is later. If there is no oral Saturdays, Sundays, and federal presentation, the decision will normally party’s position concerning the holidays. However, if a due date falls on suspension and any proposed be issued within 15 days of the date of a Saturday, Sunday, or federal holiday, revocation. No reply brief is permitted. receipt of the last reply brief. Once then the due date is the next federal (d) Oral Presentation. If an oral issued, the reviewing official will working day. presentation is requested by the immediately communicate the decision to each party. appellant or otherwise granted by the Section 16.12 What are the authority (c) Public Notice. If the suspension reviewing official, the presiding official and responsibilities of the reviewing and proposed revocation are upheld, the will attempt to schedule the oral official? presentation within 7–10 days of the revocation will become effective date of appellant’s request for review at In addition to any other authority immediately and the public will be a time and place determined by the specified in these procedures, the notified by publication of a notice in the presiding official following consultation reviewing official and the presiding Federal Register. If the suspension and with the parties. The presiding official official, with respect to those authorities proposed revocation are denied, the may hold a prehearing conference in involving the oral presentation, shall revocation will not take effect and the accordance with Section 16.8(c) and have the authority to issue orders; suspension will be lifted immediately. will conduct the oral presentation in examine witnesses; take all steps Public notice will be given by accordance with the procedures of necessary for the conduct of an orderly publication in the Federal Register. Sections 16.8(e), (f), and (g). hearing; rule on requests and motions; Section 16.15 Is there a review of the (e) Written Decision. The reviewing grant extensions of time for good final administrative action? official shall issue a written decision reasons; dismiss for failure to meet upholding or denying the suspension or deadlines or other requirements; order Before any legal action is filed in proposed revocation and will attempt to the parties to submit relevant court challenging the suspension or issue the decision within 7–10 days of information or witnesses; remand a case proposed revocation, respondent shall the date of the oral presentation or for further action by the respondent; exhaust administrative remedies within 3 days of the date on which the waive or modify these procedures in a provided under this subpart, unless transcript is received or the date of the specific case, usually with notice to the otherwise provided by Federal Law. The last submission by either party, parties; reconsider a decision of the reviewing official’s decision, under whichever is later. All other provisions reviewing official where a party Section 16.9(e) or 16.14(a) constitutes set forth in Section 16.14 will apply. promptly alleges a clear error of fact or final agency action and is ripe for (f) Transmission of Written law; and to take any other action judicial review as of the date of the Communications. Because of the necessary to resolve disputes in decision. importance of timeliness for these accordance with the objectives of these [FR Doc. 2017–00979 Filed 1–19–17; 8:45 am] expedited procedures, all written procedures. BILLING CODE 4162–20–P

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