70768 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Chapter I 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Department of Health and 

Human Services (HHS). 

ACTION: Issuance of mandatory 

guidelines. 

SUMMARY: The Department of Health and 

Human Services (‘‘HHS’’ or 

‘‘Department’’) has revised the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Urine (UrMG), which published in the 

Federal Register of January 23, 2017. 

DATES: The mandatory guidelines are 

effective February 1, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Eugene D. Hayes, Ph.D., MBA, 

SAMHSA, CSAP, DWP; 5600 Fishers 

Lane, Room 16N02, Rockville, MD 

20857, by telephone (240) 276–1459 or 

by email at Eugene.Hayes@

samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

These revised Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Urine (UrMG) establish 

a process whereby the Department 

annually publishes the authorized drug 

testing panel (i.e., drugs, analytes, or 

cutoffs) to be used for Federal 

workplace drug testing programs; revise 

the definition of a substituted specimen 

to include specimens with a biomarker 

concentration inconsistent with that 

established for a human specimen, 

establish a process whereby the 

Department publishes an authorized 

biomarker testing panel (i.e., biomarker 

analytes and cutoffs) for Federal 

workplace drug testing programs; 

update and clarify the oral fluid 

collection procedures; revise the 

confirmatory test cutoff for morphine; 

revise the Medical Review Officer 

(MRO) verification process for positive 

codeine and morphine specimens; and 

require MROs to submit semiannual 

reports to the Secretary or designated 

HHS representative on Federal agency 

specimens that were reported as 

positive for a drug or drug metabolite by 

a laboratory and verified as negative by 

the MRO. In addition, some wording 

changes have been made for clarity and 

for consistency with the Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs using Oral Fluid 

(OFMG) or to apply to any authorized 

specimen type. 

The Department is publishing a 

separate Federal Register Notification 

(FRN) elsewhere in this issue of the 

Federal Register with the revised 

OFMG, which include the same or 

similar revisions as the UrMG, where 

appropriate. 

Background 

Pursuant to its authority under 

section 503 of Public Law 100–71, 5 

U.S.C. 7301, and Executive Order 

12564, HHS establishes the scientific 

and technical guidelines for Federal 

workplace drug testing programs and 

establishes standards for certification of 

laboratories engaged in drug testing for 

Federal agencies. 

Using data obtained from the Federal 

Workplace Drug Testing Programs and 

HHS-certified laboratories, the 

Department estimates that 275,000 urine 

specimens are tested annually by 

Federal agencies. No Federal agencies 

are testing hair or oral fluid specimens 

at this time. 

HHS originally published the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(hereinafter referred to as Guidelines or 

Mandatory Guidelines) in the Federal 

Register (FR) on April 11, 1988 (53 FR 

11979). The Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) subsequently revised the 

Guidelines on June 9, 1994 (59 FR 

29908), September 30, 1997 (62 FR 

51118), November 13, 1998 (63 FR 

63483), April 13, 2004 (69 FR 19644), 

and November 25, 2008 (73 FR 71858). 

SAMHSA published the current 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Urine (UrMG) on January 23, 2017 (82 

FR 7920), and published the current 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Oral Fluid (OFMG) on October 25, 2019 

(84 FR 57554). SAMHSA published 

proposed Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Hair (HMG) on 

September 10, 2020 (85 FR 56108), and 

proposed revisions to the UrMG (87 FR 

20560) and OFMG (87 FR 20522) on 

April 7, 2022. 

There was a 60-day public comment 

period following publication of the 

proposed UrMG, during which 22 

commenters submitted 93 comments on 

the UrMG. These commenters were 

comprised of individuals, organizations, 

and private sector companies. The 

comments are available for public view 

at https://www.regulations.gov/. All 

comments were reviewed and taken into 

consideration in the preparation of the 

Guidelines. The issues and concerns 

raised in the public comments for the 

UrMG are set forth below. Similar 

comments are considered together in the 

discussion. 

Summary of Public Comments and 

HHS’s Response 

The following comments were 

directed to the information and 

questions in the preamble. 

Authorized Drug Testing Panel 

The Department requested comments 

on its proposal to publish the drug 

testing panel separately from the UrMG 

in a Federal Register Notification (FRN) 

each year. Sixteen commenters 

submitted a total of 35 comments on 

this topic for the UrMG. 

Eight commenters disagreed with 

publishing a revised drug testing panel 

without a public comment period, 

expressing concerns that stakeholders 

including individuals subject to 

federally regulated drug testing would 

not be given the opportunity to provide 

comment and that the Department 

would miss valuable input including 

information on costs and burden. Some 

of these commenters suggested alternate 

ways to permit public comment while 

enabling a quicker response to testing 

panel changes (e.g., setting a shorter 

comment period, publishing the 

Guidelines as an interim final rule or 

issuing an advance notice of proposed 

rulemaking). The Department has 

reviewed these comments and 

suggestions and determined that no 

changes to the proposed Guidelines are 

needed. The Department has developed 

procedures which will allow review and 

comment before testing panel changes 

are published, as described below. 

Consistent with current procedures, 

prior to making a change to the drug or 

biomarker testing panel, the Department 

will conduct a thorough review of the 

scientific and medical literature, and 

will solicit review and input from 

subject matter experts such as 

Responsible Persons (RPs) of HHScertified laboratories, Medical Review 

Officers (MROs), research scientists, 

manufacturers of collection devices 

and/or immunoassay kits, as well as 

Federal partners such as the Department 

of Transportation (DOT), the Food and 

Drug Administration (FDA), and the 

Drug Enforcement Administration 

(DEA). Further, the Department plans to 

provide notice and opportunity for 

public comment regarding any proposed 

changes to the drug and biomarker 

testing panels as part of Drug Testing 

Advisory Board (DTAB) meetings and 

procedures. 


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Information regarding any proposed 

changes to the drug analyte and 

biomarker testing panels and a request 

for public comment will be included in 

an advance notice of the DTAB meeting 

published in the Federal Register, along 

with the timeframe and method(s) for 

comment submission. During the 

meeting, the Department will present 

the basis for adding or removing 

analytes (i.e., including technical and 

scientific support for the proposed 

changes), as well as a discussion of 

related costs and benefits. This 

information will be provided in advance 

to DTAB members. The Department will 

review all submitted public comments 

and will share information during a 

DTAB session prior to DTAB’s review of 

SAMHSA’s recommendation to the 

Secretary regarding each proposed 

change. 

The Department will make the final 

decision on any panel changes and 

include the effective date(s) in the 

annual Notification, to allow time for 

drug testing service providers (e.g., 

immunoassay kit manufacturers, oral 

fluid collection device manufacturers) 

to develop or revise their products, and 

for HHS-certified laboratories to develop 

or revise assays, complete validation 

studies, and revise procedures. 

Four commenters disagreed that HHS 

is exempt from the Administrative 

Procedure Act (APA) requirements. Two 

of these specifically stated that the 

Guidelines are subject to APA 

requirements because DOT is required 

to use the Guidelines for their 

transportation industry drug testing 

programs. The Department explained 

why the APA does not apply under the 

Regulatory Impact and Notices section 

of the current UrMG (82 FR 7920) and 

has repeated the same information in 

that section below. 

Ten commenters were concerned that 

the Department will not allow sufficient 

time for stakeholders to implement 

changes (e.g., time for Food and Drug 

Administration [FDA] clearance for new 

or revised products, information 

technology [IT] changes, process 

development and/or changes, 

contractual changes, and training). 

Some of these commenters suggested 

that the Department set a standard time 

period (e.g., 90 days) for 

implementation of changes or based on 

the complexity of the change (e.g., 

between 90 and 365 days). The 

Department will establish a reasonable 

time for implementation based on the 

change, rather than setting a standard 

time period for all changes. As noted 

above, the Department will solicit 

information from stakeholders to assist 

in decision making. 

In regard to the use of FDA-cleared 

immunoassay initial tests, two 

commenters suggested that federally 

regulated drug testing could fall under 

what they referred to as the FDA’s 

Employment and Insurance exemption. 

The Department notes that, while some 

drugs of abuse test systems intended for 

employment and insurance testing are, 

under certain circumstances, exempt 

from the premarket notification 

procedures in 21 CFR part 807, subpart 

E, such exemptions do not apply to test 

systems intended for Federal drug 

testing programs. See 21 CFR part 862, 

subpart D. Applicant and HHS-certified 

test facilities must verify that test 

systems subject to FDA regulations are 

approved or otherwise cleared by FDA 

and, in addition, must validate test 

systems prior to use in accordance with 

requirements specified in the National 

Laboratory Certification Program (NLCP) 

Manuals for Urine Laboratories and 

Initial Instrumented Test Facilities 

(IITFs). 

One commenter appeared to 

misinterpret the Department’s testing 

panel proposal, objecting to the 

Department making changes to the 

testing panels each year. The 

Department plans to issue an annual 

Notification with the current testing 

panels and required nomenclature, but 

will make changes only when needed to 

ensure the continued effectiveness of 

Federal workplace drug testing 

programs, which may not be every year. 

Four commenters specifically agreed 

with the need to streamline and 

improve processes for making changes 

to the testing panels. Three of these 

commenters expressed concern over the 

process for testing panel review and 

who would be involved, and suggested 

involving other stakeholders (e.g., HHScertified laboratories, DTAB, FDA). As 

noted above, the Department will use 

multiple methods and involve subject 

matter experts from various stakeholder 

groups to determine testing panel 

changes, and will provide opportunity 

for public review and comment before 

changes are made. FDA, DOT, and other 

Federal partners will also have 

opportunities to review and provide 

input. 

The other commenter suggested that 

the Department include additional 

prescriptive language in each annual 

Notification (e.g., street names, 

detection times, pharmacological 

information on added drugs for MROs; 

Custody and Control Form (CCF) 

instructions for collectors). The 

Department has determined that no 

changes to the proposed Guidelines are 

needed. Relevant information and 

guidance will be included in the MRO 

Guidance Manual, Case Studies, 

Guidance for Using the Federal Custody 

and Control Form (CCF), and Specimen 

Collection Handbook. These documents 

are posted on SAMHSA’s website, 

https://www.samhsa.gov/workplace. 

One commenter stated that testing 

panel changes would lead to an increase 

in incorrect information on the Federal 

CCF. The Department disagrees, noting 

that the Federal CCF does not include 

preprinted analyte names. 

One of the commenters agreed with 

posting a Notification without a public 

comment period for added drugs, but 

disagreed with removing drugs from the 

testing panel without public comment. 

The commenter noted that entities (e.g., 

DOT, some states) are required by law 

to use the Guidelines testing panel 

should be able to continue testing those 

drugs, even if Federal agencies will not. 

The Department has determined that no 

changes to the proposed Guidelines are 

needed to address these concerns. 

See additional comments under 

Section 3.4 below. 

Authorized Biomarker Testing Panel 

The Department requested comments 

on its proposal to publish the biomarker 

testing panel separately from the UrMG 

in the Federal Register each year. Five 

commenters submitted a total of 12 

comments on this topic for the UrMG. 

Two commenters disagreed with 

publishing a biomarker testing panel 

without a public comment period, 

expressing concerns that stakeholders 

would not be given the opportunity to 

provide comment and that the 

Department would miss valuable input 

including information on costs and 

burden. 

Two other commenters specifically 

agreed with the need to streamline and 

improve processes for making changes 

to the testing panels, but suggested 

involving other stakeholders (e.g., HHScertified laboratories, DTAB). The 

Department has reviewed these 

comments and determined that no 

changes to the proposed Guidelines are 

needed. The Department has developed 

procedures which will allow review and 

comment before testing panel changes 

are published, as described under 

Authorized drug testing panel above. 

One commenter disagreed that HHS is 

exempt from the APA requirements. The 

Department has reviewed the comment 

and determined that no change is 

needed to the proposed Guidelines. The 

Department explained why the APA 

does not apply under the Regulatory 

Impact and Notices section of the 

current UrMG (82 FR 7920) and has 

repeated the same information in that 

section below. 


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Two commenters were concerned that 

the Department will not allow sufficient 

time for stakeholders to implement 

changes (e.g., time for information 

technology [IT] changes, process 

development and/or changes, training). 

The commenters suggested that the 

Department set a standard time for 

implementation of all changes (e.g., 90 

days, six months). As noted under 

Authorized drug testing panel above, 

the Department will establish a 

reasonable time for implementation 

based on the change, rather than setting 

a standard time period for all changes, 

and will solicit information from 

multiple sources to assist in decision 

making. 

Two commenters suggested that the 

Department require all HHS-certified 

laboratories to perform standardized 

specimen validity and biomarker tests 

on all federally regulated specimens, 

and allow laboratories to choose 

whether to offer additional specialized 

tests upon MRO request on a case-bycase basis. This is consistent with 

current UrMG requirements for 

specimen validity testing. The 

Department is not requiring all certified 

laboratories to conduct biomarker 

testing at this time. However, if the drug 

testing industry identifies a need for 

such tests and an HHS-certified 

laboratory chooses to offer a biomarker 

test to their regulated clients, the 

Department will ensure that the tests 

provide scientifically valid and 

forensically defensible results and will 

revisit the need for requiring the test on 

all specimens. 

Medical Review Officer (MRO) 

Verification of Codeine and Morphine 

Test Results 

The Department removed the 

additional decision point for codeine 

and morphine, adjusted the 

confirmatory test cutoff for morphine 

from 2,000 to 4,000 ng/mL, and 

removed the additional requirement for 

clinical evidence of illegal opioid use. 

The Department received one comment 

agreeing with these changes to the 

UrMG. 

Medical Review Officer (MRO) 

Semiannual Reports 

In Section 13.11, the Department 

added requirements for each MRO 

performing medical review services for 

Federal agencies to submit semiannual 

reports, in January and July of each year, 

of Federal agency specimens that were 

reported as positive for a drug or drug 

metabolite by the laboratory and 

verified as negative by the MRO, along 

with the reason for the negative 

verification (e.g., a valid prescription for 

a drug). Six commenters submitted six 

comments on this topic for the UrMG. 

Four commenters disagreed, stating 

that HHS had not clearly described the 

reason and the process for such reports. 

One commenter noted that the 

Department had not presented data 

documenting that MROs were 

incorrectly reporting specimens, and it 

was unclear how the reports could be 

matched to laboratory report 

information submitted to the National 

Laboratory Certification Program 

(NLCP). Another commenter was 

concerned that donors would be 

identifiable, and that ‘‘a database of 

legal drug use’’ would violate donor 

privacy. One of the commenters 

expressed concern over ‘‘unintended 

consequences’’ for DOT and state 

workplace drug testing programs, 

without further explanation. 

One commenter disagreed on the 

basis of added costs and burden to 

MROs (e.g., system revisions, increased 

staff workload). 

One commenter agreed that such 

reports could be beneficial, but 

suggested that MROs provide the same 

information as provided by laboratories 

to the NLCP. The commenter incorrectly 

stated that laboratories do not provide 

specimen identification numbers to the 

NLCP. 

The Department has reviewed the 

comments and determined that no 

change is needed to the proposed 

Guidelines. To clarify, this reporting 

policy is only for Federal agency 

specimens, not DOT-regulated 

specimens. Further, the reports are not 

for all positive specimens, only for those 

specimens that were reported as 

positive by the laboratory and verified 

as negative by the MRO. The requested 

MRO information is sufficient to enable 

matching to HHS-certified laboratory 

information provided to the NLCP 

without identifying the donor. At this 

time, there is no system-wide 

mechanism for identifying MRO 

verification practices for Federal agency 

specimens that are inconsistent with the 

Mandatory Guidelines, so data on 

incorrect reporting is not available. The 

Department is not planning to share 

MRO-specific information, but may 

share statistical information and 

deidentified examples of incorrect 

reporting by various means (e.g., DTAB 

meeting presentations, revisions to the 

MRO Guidance Manual and/or Case 

Studies). The Department will also 

provide this information to HHSapproved MRO certification 

organizations to share with their 

certified MROs and to update training 

materials and examinations as needed. 

Marijuana Testing 

The Department did not propose any 

changes to the UrMG in regard to 

marijuana testing, but received three 

comments from three commenters 

disagreeing with the current 

requirements. Two commenters 

supported medical use of marijuana. 

One commenter supported legalization 

of marijuana in general. 

Current Federal law requires Federal 

agencies to test for marijuana under E.O. 

12564 in their workplace drug testing 

programs. The Department also edited 

Section 13.5(c) to clarify that only 

prescription medications can be offered 

as a legitimate medical explanation for 

a positive drug test (as described under 

Section 13.5 below). No further edits are 

required at this time. 

Discussion of Sections 

The Department has not included a 

discussion in the preamble of any 

sections for which public comments 

were not submitted or for minor 

wording changes (e.g., edits for clarity, 

typographical or grammatical 

corrections). 

Subpart A—Applicability 

Section 1.5 What do the terms used in 

these Guidelines mean? 

Two commenters agreed and one 

disagreed with the Department’s 

proposed revision to the Substituted 

Specimen definition in Section 1.5 to 

include specimens tested for a 

biomarker. The commenter who 

disagreed stated that there are situations 

in which a legitimate specimen may be 

reported as outside the standards for 

human specimens, and these should be 

reported as invalid. The Department has 

reviewed the comment and determined 

that no change is needed to the 

proposed Guidelines. The Department 

will follow the procedures summarized 

under Authorized drug testing panel 

above to enable public comment and 

review, and will ensure that a biomarker 

test is scientifically supported and 

forensically sound to identify specimens 

as substituted before allowing its use 

with federally regulated drug testing. 

Specimens that do not meet established 

criteria for the biomarker test will not be 

reported as substituted. 

Section 1.7 What is a refusal to take a 

federally regulated drug test? 

In Section 1.7(a), the Department 

proposed to remove two exceptions for 

reporting a refusal to test for a preemployment test: a donor who fails to 

appear in a reasonable time and a donor 

who leaves the collection site before the 

collection process begins. Seven 


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commenters submitted seven comments 

on this proposal. 

Five commenters disagreed with the 

changes, noting that an applicant may 

fail to appear because they have taken 

a different job offer. The commenters 

noted that a refusal to test in the 

individual’s record could prevent 

individuals from taking other job offers 

and/or require them to undergo 

unnecessary return-to-duty testing. The 

Department has reviewed the comments 

and determined that no change is 

needed. As stated in this section, the 

Federal agency determines a reasonable 

time for the donor to take the test, 

consistent with applicable agency 

regulations, and directs the individual 

accordingly. At the time an applicant is 

scheduled for a pre-employment drug 

test, or before, Federal agencies should 

provide the applicant with instructions 

on how to notify the agency in the event 

that they decide to withdraw their 

application or to not accept a job offer. 

Such instructions will allow the agency 

to cancel the drug test and help 

applicants avoid a refusal to test result. 

One commenter noted that the 

Guidelines should state that the 

designated employer representative 

(DER) makes the determination of a 

refusal to test. The Department has 

reviewed the comment and determined 

that no change is needed. As stated in 

this section, the Federal agency takes 

action consistent with applicable agency 

regulations. 

Subpart C—Urine Specimen Tests 

Section 3.4 What are the drug and 

biomarker test analytes and cutoffs for 

urine? 

The Department revised Section 3.4 to 

describe the annual publication of the 

drug testing and biomarker testing 

panels and the nomenclature required 

for laboratory and MRO reports. Three 

commenters submitted four comments 

on the required nomenclature required 

for laboratory and MRO reports, which 

are addressed below. Comments on the 

testing panels are addressed under 

Authorized drug testing panel and 

Authorized biomarker testing panel 

above. 

In regard to the required 

nomenclature specified in the annual 

Federal Register Notification, two 

commenters noted it is difficult and 

requires substantial effort for 

stakeholders to make such changes to 

their information technology (IT) 

systems. These commenters suggested 

that HHS convene a working group for 

review and input on nomenclature 

changes, to include employers, third 

party administrators, providers of 

electronic Federal Custody and Control 

Forms (ECCF providers), laboratories, 

and MROs. One commenter agreed with 

publishing the required nomenclature 

for each change to the testing panel, but 

suggested that nomenclature not be 

changed after publication to avoid 

increased costs and confusion. One 

commenter recommended a minimum 

of one-year implementation period after 

nomenclature changes are published. 

The Department will establish 

required terminology based on correct 

scientific nomenclature for added 

analytes. As described under 

Authorized drug testing panel above, 

the Department has developed 

procedures to allow public notice and 

comment on proposed drug analyte 

changes through DTAB meetings and 

procedures. The Department will 

publish separate nomenclature lists for 

urine and oral fluid analytes. 

Subpart F—Federal Drug Testing 

Custody and Control Form 

Section 6.2 What happens if the 

correct Office of Management and 

Budget (OMB)-approved Federal CCF is 

not available or is not used? 

One commenter stated that the 

Department should specify what 

constitutes an incorrect form, how a 

collector’s signed memorandum must be 

submitted to correct submission of an 

incorrect CCF, and what actions an 

HHS-certified laboratory must take in 

response to an incorrect CCF. The 

Department has determined that no 

changes to the Guidelines are needed. 

The Department issues Guidance for 

Using the Federal CCF as part of the 

OMB-approved package and provides 

information and guidance specific to the 

current and expired versions of the 

Federal CCF, rather than including them 

in these Guidelines. 

Subpart H—Urine Specimen Collection 

Procedure 

8.3 What are the preliminary steps in 

the urine specimen collection 

procedure? 

There were no comments on this 

section; however, the Department added 

a sentence in item h stating that a donor 

is not required to remove any items 

worn for faith-based reasons. This 

requirement will be specified for all 

authorized specimen types. 

Subpart K—Laboratory 

Section 11.20 How long must an HHScertified laboratory retain specimens? 

The Department did not propose any 

changes to this section. One commenter 

submitted a comment specifically 

agreeing with the existing UrMG 

requirement for laboratories to maintain 

substituted urine specimens for a period 

of one year after reporting. The 

comment appeared to be in response to 

DOT’s February 28, 2022 notice of 

proposed rulemaking (NPRM) for 

transportation industry drug testing 

programs. 

Subpart M—Medical Review Officer 

(MRO) 

Section 13.3 What training is required 

before a physician may serve as an 

MRO? 

The Department did not propose any 

changes to this section; however, one 

commenter indicated that this section is 

unclear and needs substantial 

clarification regarding additional MRO 

training (e.g., what must training consist 

of, must the MRO take another 

certification exam, would this be 

required for annual panel changes). The 

commenter also suggested that MROs 

register with SAMHSA to get updates/ 

announcements and acknowledge 

review of that information. 

The Department has reviewed these 

comments and edited item b of this 

section to clarify that MROs must be 

trained on any revisions to the drug and 

biomarker testing panels. In regard to 

training, SAMHSA relies on the 

approved MRO certification entities to 

ensure that MROs certified by their 

organizations meet Guidelines 

requirements. Current documents on the 

SAMHSA website https://

www.samhsa.gov/workplace include the 

HHS Medical Review Officer Guidance 

Manual, MRO Cases Studies for Urine, 

and MRO Case Studies for Urine which 

address most of the suggested topics. 

The Department does not maintain an 

email list, but sends a notice through 

the NLCP to HHS-approved MRO 

certification organizations for 

dissemination to their certified MROs. 

The Department also sends additional 

guidance to HHS-certified laboratories 

to share with MROs, clients, and 

collectors as applicable. 

Section 13.5 What must an MRO do 

when reviewing a urine specimen’s test 

results? 

The Department revised Section 

13.5(d)(2) to clarify that passive 

exposure to any drug (not just marijuana 

smoke) and ingestion of food products 

containing a drug (not just those 

containing marijuana) are not acceptable 

medical explanations for a positive drug 

test. The Department also added Section 

13.5(d)(2)(iii) to clarify that only 

prescription medications can be offered 

as a legitimate medical explanation for 


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a positive drug test. Two commenters 

disagreed with the addition of Section 

13.5(d)(2)(iii), maintaining that a 

physician’s recommendation for 

medical marijuana should be considered 

a legitimate medical explanation for a 

positive test. The Department has 

evaluated these comments and 

determined that no change is needed at 

this time. Although an increased 

number of States have authorized 

marijuana use for medical purposes, 

marijuana remains a Schedule I 

controlled substance and cannot be 

prescribed under Federal law. For 

purposes of the Federal drug free 

workplace program, Federal law 

pertaining to marijuana control 

supersedes State marijuana laws, and 

therefore, a physician’s 

recommendation for marijuana use is 

not a legitimate medical explanation for 

a positive marijuana test. Also see 

comments under Marijuana testing 

above. 

In addition to the changes described 

above, the Department reordered UrMG 

Sections 13.8 and 13.9 to reflect the 

procedural order (i.e., requirements for 

an MRO to report a primary specimen 

test result are now in Section 13.8, and 

requests for a test of the split specimen 

are addressed in Section 13.9). 

Regulatory Impact and Notices 

The potential impact that these 

Guidelines have on the Department of 

Transportation (DOT) and/or Nuclear 

Regulatory Commission (NRC) regulated 

industries depends on the extent to 

which these agencies incorporate the 

UrMG revisions into their regulatory 

programs. Therefore, analysis of the 

potential impact of these Guidelines on 

such programs falls under the regulatory 

purview of DOT and NRC. 

Executive Order 14094, 13563, and 

12866 

Executive Order 14094 of April 6, 

2023 (Modernizing Regulatory Review) 

reaffirms the statement set forth in 

13563 of January 18, 2011 (Improving 

Regulation and Regulatory Review) that 

‘‘Our regulatory system must protect 

public health, welfare, safety, and our 

environment while promoting economic 

growth, innovation, competitiveness, 

and job creation.’’ Consistent with this 

mandate, Executive Order 13563 

requires agencies to tailor ‘‘regulations 

to impose the least burden on society, 

consistent with obtaining regulatory 

objectives.’’ Executive Order 13563 also 

requires agencies to ‘‘identify and 

consider regulatory approaches that 

reduce burdens and maintain flexibility 

and freedom of choice’’ while selecting 

‘‘those approaches that maximize net 

benefits.’’ The regulatory approach in 

this document will reduce burdens to 

providers and to consumers while 

continuing to provide adequate 

protections for public health and 

welfare. 

The Secretary has examined the 

impact of the Guidelines under 

Executive Order 12866, as amended by 

Executive Order 14094, which directs 

Federal agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). 

According to Executive Order 12866, 

as amended by Executive Order 14094, 

defines a ‘‘significant regulatory action’’ 

as one that is likely to result in a rule 

that may meet any one of a number of 

specified conditions, including: (1) have 

an annual effect on the economy of $200 

million or more in any one year 

(adjusted every 3 years by the 

Administrator of the Office of 

Information and Regulatory Affairs 

(OIRA) for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise legal or 

policy issues for which centralized 

review would meaningfully further the 

President’s priorities or the principles 

set forth in the Executive order, as 

specifically authorized in a timely 

manner by the Administrator of OIRA in 

each case. The Administrative 

Procedure Act (APA) delineates an 

exception to its rulemaking procedures 

for ‘‘a matter relating to agency 

management or personnel’’ 5 U.S.C. 

553(a)(2). Because the Guidelines issued 

by the Secretary govern Federal 

workplace drug testing programs, HHS 

has taken the position that the 

Guidelines are a ‘‘matter relating to 

agency management or personnel’’ and, 

thus, are not subject to the APA’s 

requirements for notice and comment 

rulemaking. This position is consistent 

with Executive Order 12564 regarding 

Drug-Free Workplaces, which directs 

the Secretary to promulgate scientific 

and technical guidelines for executive 

agency drug testing programs. 

Costs and Benefits 

The Department included a 

Regulatory Impact and Notices section 

with cost and benefits analysis and 

burden estimates in the April 7, 2022 

Federal Register Notification for the 

proposed UrMG (87 FR 20560), and 

requested public comment on all 

estimates and assumptions. Two 

commenters submitted comments 

concerning the Department’s costs and 

benefits analysis. 

One commenter noted that the 

Department did not consider the 

application of the Guidelines to DOT 

testing, and recommended reanalysis of 

the costs and burden of the proposed 

changes with consideration of the 

impact on testing by the transportation 

industry. Please see the first paragraph 

of the Regulatory Impact and Notices 

section above. 

The other commenter disagreed with 

the Department’s statement in the 

preamble to the proposed UrMG that 

‘‘implementation costs would be lower 

for laboratories that already offer the 

drug test’’ compared to those 

laboratories that do not test for the 

added drug. The commenter indicated 

that the list of cost impacts for any 

change should include the laboratory’s 

assay validation, materials management, 

and updates to IT systems (e.g., 

laboratory information management 

system [LIMS], recipient systems, and 

electronic ordering systems). This 

commenter indicated that these 

additional costs should be considered, 

and that they will be dependent on the 

complexity and adaptability of these 

systems. The Department agrees that 

costs will depend on the change and 

noted that in the preamble to the 

proposed UrMG. The Department will 

continue to proactively solicit cost 

information from stakeholders when 

conducting a cost analysis. As described 

under Authorized drug testing panel 

above, the Department will include a 

discussion of related costs and benefits 

when presenting a proposed panel 

change during a DTAB meeting. 

Information Collection/Record Keeping 

Requirements 

The information collection 

requirements (i.e., reporting and 

recordkeeping) in the current 

Guidelines, which establish the 

scientific and technical guidelines for 

Federal workplace drug testing 

programs and establish standards for 

certification of laboratories engaged in 

urine drug testing for Federal agencies 

under authority of 5 U.S.C. 7301 and 

Executive Order 12564, are approved by 

the Office of Management and Budget 


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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 70773 

(OMB) under control number 0930– 

0158. The Federal Drug Testing Custody 

and Control Form (Federal CCF) used to 

document the collection and chain of 

custody of urine and oral fluid 

specimens at the collection site, for 

laboratories to report results, and for 

Medical Review Officers to make a 

determination; the National Laboratory 

Certification Program (NLCP) 

application; the NLCP Laboratory 

Information Checklist; and 

recordkeeping requirements in the 

current Guidelines, as approved under 

control number 0930–0158, will remain 

in effect. 

In support of the Government 

Paperwork Reduction Act (PRA), the 

Department revised the Federal CCF to 

enable its use as an electronic form (78 

FR 42091, July 15, 2013) and developed 

requirements and oversight procedures 

to ensure that HHS-certified test 

facilities and other service providers 

(e.g., collection sites, MROs) using an 

electronic version of the Federal CCF 

(ECCF) maintain the accuracy, security, 

and confidentiality of electronic drug 

test information. Before a Federal ECCF 

can be used for Federal agency 

specimens, HHS-certified test facilities 

must submit detailed information and 

proposed standard operating procedures 

(SOPs) to the NLCP for SAMHSA review 

and approval, and undergo an NLCP 

inspection focused on the proposed 

ECCF. 

Since 2013, SAMHSA has encouraged 

the use of Federal ECCFs and other 

electronic processes in HHS-certified 

test facilities, when practicable, for 

federally regulated testing operations. In 

accordance with section 8108(a) of the 

SUPPORT for Patients and Communities 

Act, SAMHSA originally set a deadline 

of August 31, 2023 for all HHS-certified 

laboratories to submit a request for 

approval of a digital (paperless) 

electronic Federal CCF. The Department 

subsequently extended the deadline to 

August 31, 2026, to enable sufficient 

time for all HHS-certified laboratories to 

identify and contract with an ECCF 

supplier or to develop an ECCF. 

The title and description of the 

information collected and respondent 

description are shown in the following 

paragraphs with an estimate of the 

annual reporting, disclosure, and 

recordkeeping burden. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

Title: The Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine. 

Description: The Mandatory 

Guidelines establish the scientific and 

technical guidelines for Federal drug 

testing programs and establish standards 

for certification of laboratories engaged 

in drug testing for Federal agencies 

under authority of Public Law 100–71, 

5 U.S.C. 7301 note, and Executive Order 

12564. Federal drug testing programs 

test applicants to sensitive positions, 

individuals involved in accidents, 

individuals for cause, and random 

testing of persons in sensitive positions. 

Description of Respondents: 

Individuals or households, businesses, 

or other-for-profit and not-for-profit 

institutions. 

The burden estimates in the tables 

below are based on the following 

number of respondents: 38,000 donors 

who apply for employment or are 

employed in testing designated 

positions, 100 collectors, 25 urine 

specimen testing laboratories, 1 IITF, 

and 100 MROs. 

ESTIMATE OF ANNUAL REPORTING BURDEN

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

9.2(a)(1) ......................... Laboratory or IITF required to submit application 

for certification.

10 1 3 30 

9.12(a)(3) ....................... Materials to submit to become an HHS inspector.10 1 2 20 

11.3 ................................ Laboratory submits qualifications of responsible 

person (RP) to HHS.

10 1 2 20 

11.4(c) ............................ Laboratory submits information to HHS on new 

RP or alternate RP.

10 1 2 20 

11.22 .............................. Specifications for laboratory semiannual statistical report of test results to each Federal 

agency.

10 5 0.5 25 

12.3(a) ........................... IITF 1 submits qualifications of RT to HHS ......... 1 1 1 1 

12.4(c) ............................ IITF 1 submits information to HHS on new RT or 

alternate RT.

1 1 1 1 

12.19 .............................. Specifications for IITF 1 semiannual statistical 

report of test results to each Federal agency.

1 1 1 1 

13.8 and 14.7 ................ Specifies that MRO must report all verified primary and split specimen test results to the 

Federal agency.

100 14 0.05 (3 min) 70 

13.11 .............................. Specifications for MRO semiannual report to the 

Secretary or designated representative for 

Federal agency specimen results that were 

laboratory-positive and MRO-verified negative.

100 2 0.5 100 

16.1(b) & 16.5(a) ........... Specifies content of request for informal review 

of suspension/proposed revocation of certification.

1 1 3 3 

16.4 ................................ Specifies information appellant provides in first 

written submission when laboratory suspension/revocation is proposed.

1 1 0.5 0.5 

16.6 ................................ Requires appellant to notify reviewing official of 

resolution status at end of abeyance period.

1 1 0.5 0.5 

16.7(a) ........................... Specifies contents of appellant submission for 

review.

1 1 50 50 


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ESTIMATE OF ANNUAL REPORTING BURDEN—Continued 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

16.9(a) ........................... Specifies content of appellant request for expedited review of suspension or proposed revocation.1 1 3 3 

16.9(c) ............................ Specifies contents of review file and briefs ......... 1 1 50 50 

Total ........................ .............................................................................. 259 ........................ ........................ 395 

1Although IITFs are allowed under the UrMG, SAMHSA has not received any IITF application for certification to test federally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes. 

The following reporting requirements 

are also in the Guidelines, but have not 

been addressed in the above reporting 

burden table: collector must report any 

unusual donor behavior or refusal to 

participate in the collection process on 

the Federal CCF (Sections 1.8, 8.9); 

collector annotates the Federal CCF 

when a sample is a blind sample 

(Section 10.3(a)); MRO notifies the 

Federal agency and HHS when an error 

occurs on a blind sample (Section 

10.4(d)); and Sections 13.6 and 13.7 

describe the actions an MRO takes for 

the medical evaluation of a donor who 

cannot provide a urine specimen. 

SAMHSA has not calculated a separate 

reporting burden for these requirements 

because they are included in the burden 

hours estimated for collectors to 

complete Federal CCFs and for MROs to 

report results to Federal agencies. 

ESTIMATE OF ANNUAL DISCLOSURE BURDEN

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response 

Total 

hours 

8.3(a), 8.5(f)(2)(iii), 

8.6(b)(2).

Collector must contact Federal agency point of 

contact.

100 1 0.05 (3 min) 5 

11.23, 11.24 ................... Information on drug test that laboratory must 

provide to Federal agency upon request or to 

donor through MRO.

25 10 3 750 

12.20, 12.21 ................... Information on drug test that IITF must provide 

to Federal agency upon request or to donor 

through MRO.

1 1 1 1 

13.9(b) ........................... MRO must inform donor of right to request split 

specimen test when a positive, adulterated, or 

substituted result is reported.

100 14 3 4,200 

Total ........................ .............................................................................. 226 ........................ ........................ 4956 

The following disclosure 

requirements are also included in the 

Guidelines, but have not been addressed 

in the above disclosure burden table: the 

collector must explain the basic 

collection procedure to the donor and 

answer any questions (Section 8.3(e) 

and (g)). SAMHSA believes having the 

collector explain the collection 

procedure to the donor and answer any 

questions is a standard business practice 

and not a disclosure burden. 

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response 

Total 

hours 

8.3, 8.5, 8.8 ................... Collector completes Federal CCF for specimen 

collected.

100 380 0.07 (4 min) 2,660 

8.8(d) & (f) ..................... Donor initials specimen labels/seals and signs 

statement on the Federal CCF.

38,000 1 0.08 (5 min) 3,040 

11.8(a) & 11.19 .............. Laboratory completes Federal CCF upon receipt 

of specimen and before reporting result.

25 1,520 0.05 (3 min) 1,900 

12.8(a) & 12.15 .............. IITF completes Federal CCF upon receipt of 

specimen and before reporting result.

1 1 1 1 

13.4(d)(4), 13.8(c), 

14.7(c).

MRO completes Federal CCF before reporting 

the primary or split specimen result.

100 380 0.05 (3 min) 1,900 

14.1(b) ........................... MRO documents donor’s request to have split 

specimen tested.

100 2 0.05 (3 min) 10 

Total ........................ .............................................................................. 38,326 ........................ ........................ 9,511 

The Guidelines contain several 

recordkeeping requirements that 

SAMHSA considers not to be an 

additional recordkeeping burden. In 

subpart D, a trainer is required to 

document the training of an individual 


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to be a collector (Section 4.3(a)(3)) and 

the documentation must be maintained 

in the collector’s training file (Section 

4.3(c)). SAMHSA believes this training 

documentation is common practice and 

is not considered an additional burden. 

In subpart F, if a collector uses an 

incorrect form to collect a Federal 

agency specimen, the collector is 

required to provide a statement (Section 

6.2(b)) explaining why an incorrect form 

was used to document collecting the 

specimen. SAMHSA believes this is an 

extremely infrequent occurrence and 

does not create a significant additional 

recordkeeping burden. Subpart H 

(Sections 8.4(c), 8.5(d)(2) and (e)(1) and 

(2)) requires collectors to enter any 

information on the Federal CCF of any 

unusual findings during the urine 

specimen collection procedure. These 

recordkeeping requirements are an 

integral part of the collection procedure 

and are essential to documenting the 

chain of custody for the specimens 

collected. The burden for these entries 

is included in the recordkeeping burden 

estimated to complete the Federal CCF 

and is, therefore, not considered an 

additional recordkeeping burden. 

Subpart K describes a number of 

recordkeeping requirements for 

laboratories associated with their testing 

procedures, maintaining chain of 

custody, and keeping records (i.e., 

Sections 11.1(a) and (d); 11.2(b), (c), and 

(d); 11.6(b); 11.7(c); 11.8; 11.11(a); 

11.14(a); 11.17; 11.21(a), (b), and (c); 

11.22; 11.23(a); and 11.24). These 

recordkeeping requirements are 

necessary for any laboratory to conduct 

forensic drug testing and to ensure the 

scientific supportability of the test 

results. These practices are integrated in 

the current processes and, therefore, 

SAMHSA does not consider these 

standard business practices to be an 

additional burden for disclosure. Thus, 

the total annual response burden 

associated with the testing of urine 

specimens by the laboratories and IITFs 

is estimated to be 14,862 hours (that is, 

the sum of the total hours from the 

above tables). This is in addition to the 

1,788,809 hours currently approved by 

OMB under control number 0930–0158 

for urine testing under the current 

Guidelines. 

As required by section 3507(d) of the 

PRA, the Secretary submitted a copy of 

the proposed Guidelines to OMB for its 

review. Comments on the information 

collection requirements were 

specifically solicited in order to: (1) 

Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of HHS’s 

functions, including whether the 

information will have practical utility; 

(2) evaluate the accuracy of HHS’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) enhance the 

quality, utility, and clarity of the 

information to be collected; and (4) 

minimize the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Dated: September 27, 2023. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

Using Urine Specimens 

Subpart A—Applicability 

1.1 To whom do these Guidelines apply? 

1.2 Who is responsible for developing and 

implementing these Guidelines? 

1.3 How does a Federal agency request a 

change from these Guidelines? 

1.4 How are these Guidelines revised? 

1.5 What do the terms used in these 

Guidelines mean? 

1.6 What is an agency required to do to 

protect employee records? 

1.7 What is a refusal to take a federally 

regulated drug test? 

1.8 What are the potential consequences for 

refusing to take a federally regulated 

drug test? 

Subpart B—Urine Specimens 

2.1 What type of specimen may be 

collected? 

2.2 Under what circumstances may a urine 

specimen be collected? 

2.3 How is each urine specimen collected? 

2.4 What volume of urine is collected? 

2.5 How does the collector split the urine 

specimen? 

2.6 When may an entity or individual 

release a urine specimen? 

Subpart C—Urine Specimen Tests 

3.1 Which tests are conducted on a urine 

specimen? 

3.2 May a specimen be tested for drugs 

other than those in the drug testing 

panel? 

3.3 May any of the specimens be used for 

other purposes? 

3.4 What are the drug and biomarker test 

analytes and cutoffs for urine? 

3.5 May an HHS-certified laboratory 

perform additional drug and/or 

specimen validity tests on a specimen at 

the request of the Medical Review 

Officer (MRO)? 

3.6 What criteria are used to report a urine 

specimen as adulterated? 

3.7 What criteria are used to report a urine 

specimen as substituted? 

3.8 What criteria are used to report a urine 

specimen as dilute? 

3.9 What criteria are used to report an 

invalid result for a urine specimen? 

Subpart D—Collectors 

4.1 Who may collect a specimen? 

4.2 Who may not collect a specimen? 

4.3 What are the requirements to be a 

collector? 

4.4 What are the requirements to be an 

observer for a direct observed collection? 

4.5 What are the requirements to be a 

trainer for collectors? 

4.6 What must a Federal agency do before 

a collector is permitted to collect a 

specimen? 

Subpart E—Collection Sites 

5.1 Where can a collection for a drug test 

take place? 

5.2 What are the requirements for a 

collection site? 

5.3 Where must collection site records be 

stored? 

5.4 How long must collection site records 

be stored? 

5.5 How does the collector ensure the 

security and integrity of a specimen at 

the collection site? 

5.6 What are the privacy requirements 

when collecting a urine specimen? 

Subpart F—Federal Drug Testing Custody 

and Control Form 

6.1 What Federal form is used to document 

custody and control? 

6.2 What happens if the correct OMBapproved Federal CCF is not available or 

is not used? 

Subpart G—Urine Specimen Collection 

Containers and Bottles 

7.1 What is used to collect a urine 

specimen? 

7.2 What are the requirements for a urine 

collection container and specimen 

bottles? 

7.3 What are the minimum performance 

requirements for a urine collection 

container and specimen bottles? 

Subpart H—Urine Specimen Collection 

Procedure 

8.1 What privacy must the donor be given 

when providing a urine specimen? 

8.2 What must the collector ensure at the 

collection site before starting a urine 

specimen collection? 

8.3 What are the preliminary steps in the 

urine specimen collection procedure? 

8.4 What steps does the collector take in the 

collection procedure before the donor 

provides a urine specimen? 

8.5 What steps does the collector take 

during and after the urine specimen 

collection procedure? 

8.6 What procedure is used when the donor 

states that they are unable to provide a 

urine specimen? 

8.7 If the donor is unable to provide a urine 

specimen, may another specimen type be 

collected for testing? 

8.8 How does the collector prepare the 

urine specimens? 

8.9 When is a direct observed collection 

conducted? 

8.10 How is a direct observed collection 

conducted? 


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8.11 When is a monitored collection 

conducted? 

8.12 How is a monitored collection 

conducted? 

8.13 How does the collector report a 

donor’s refusal to test? 

8.14 What are a Federal agency’s 

responsibilities for a collection site? 

Subpart I—HHS Certification of 

Laboratories and IITFs 

9.1 Who has the authority to certify 

laboratories and IITFs to test urine 

specimens for Federal agencies? 

9.2 What is the process for a laboratory or 

IITF to become HHS-certified? 

9.3 What is the process for a laboratory or 

IITF to maintain HHS certification? 

9.4 What is the process when a laboratory 

or IITF does not maintain its HHS 

certification? 

9.5 What are the qualitative and 

quantitative specifications of 

performance testing (PT) samples? 

9.6 What are the PT requirements for an 

applicant laboratory that seeks to 

perform urine testing? 

9.7 What are the PT requirements for an 

HHS-certified urine laboratory? 

9.8 What are the PT requirements for an 

applicant IITF? 

9.9 What are the PT requirements for an 

HHS-certified IITF? 

9.10 What are the inspection requirements 

for an applicant laboratory or IITF? 

9.11 What are the maintenance inspection 

requirements for an HHS-certified 

laboratory or IITF? 

9.12 Who can inspect an HHS-certified 

laboratory or IITF and when may the 

inspection be conducted? 

9.13 What happens if an applicant 

laboratory or IITF does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

9.14 What happens if an HHS-certified 

laboratory or IITF does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

9.15 What factors are considered in 

determining whether revocation of a 

laboratory’s or IITF’s HHS certification is 

necessary? 

9.16 What factors are considered in 

determining whether to suspend a 

laboratory’s or an IITF’s HHS 

certification? 

9.17 How does the Secretary notify an HHScertified laboratory or IITF that action is 

being taken against the laboratory or 

IITF? 

9.18 May a laboratory or IITF that had its 

HHS certification revoked be recertified 

to test Federal agency specimens? 

9.19 Where is the list of HHS-certified 

laboratories and IITFs published? 

Subpart J—Blind Samples Submitted by an 

Agency 

10.1 What are the requirements for Federal 

agencies to submit blind samples to 

HHS-certified laboratories or IITFs? 

10.2 What are the requirements for blind 

samples? 

10.3 How is a blind sample submitted to an 

HHS-certified laboratory or IITF? 

10.4 What happens if an inconsistent result 

is reported for a blind sample? 

Subpart K—Laboratory 

11.1 What must be included in the HHScertified laboratory’s standard operating 

procedure manual? 

11.2 What are the responsibilities of the 

responsible person (RP)? 

11.3 What scientific qualifications must the 

RP have? 

11.4 What happens when the RP is absent 

or leaves an HHS-certified laboratory? 

11.5 What qualifications must an individual 

have to certify a result reported by an 

HHS-certified laboratory? 

11.6 What qualifications and training must 

other personnel of an HHS-certified 

laboratory have? 

11.7 What security measures must an HHScertified laboratory maintain? 

11.8 What are the laboratory chain of 

custody requirements for specimens and 

aliquots? 

11.9 What test(s) does an HHS-certified 

laboratory conduct on a urine specimen 

received from an IITF? 

11.10 What are the requirements for an 

initial drug test? 

11.11 What must an HHS-certified 

laboratory do to validate an initial drug 

test? 

11.12 What are the batch quality control 

requirements when conducting an initial 

drug test? 

11.13 What are the requirements for a 

confirmatory drug test? 

11.14 What must an HHS-certified 

laboratory do to validate a confirmatory 

drug test? 

11.15 What are the batch quality control 

requirements when conducting a 

confirmatory drug test? 

11.16 What are the analytical and quality 

control requirements for conducting 

specimen validity tests? 

11.17 What must an HHS-certified 

laboratory do to validate a specimen 

validity test? 

11.18 What are the requirements for 

conducting each specimen validity test? 

11.19 What are the requirements for an 

HHS-certified laboratory to report a test 

result? 

11.20 How long must an HHS-certified 

laboratory retain specimens? 

11.21 How long must an HHS-certified 

laboratory retain records? 

11.22 What statistical summary reports 

must an HHS-certified laboratory 

provide for urine testing? 

11.23 What HHS-certified laboratory 

information is available to a Federal 

agency? 

11.24 What HHS-certified laboratory 

information is available to a Federal 

employee? 

11.25 What types of relationships are 

prohibited between an HHS-certified 

laboratory and an MRO? 

11.26 What type of relationship can exist 

between an HHS-certified laboratory and 

an HHS-certified IITF? 

Subpart L—Instrumented Initial Test Facility 

(IITF) 

12.1 What must be included in the HHScertified IITF’s standard operating 

procedure manual? 

12.2 What are the responsibilities of the 

responsible technician (RT)? 

12.3 What qualifications must the RT have? 

12.4 What happens when the RT is absent 

or leaves an HHS-certified IITF? 

12.5 What qualifications must an individual 

have to certify a result reported by an 

HHS-certified IITF? 

12.6 What qualifications and training must 

other personnel of an HHS-certified IITF 

have? 

12.7 What security measures must an HHScertified IITF maintain? 

12.8 What are the IITF chain of custody 

requirements for specimens and 

aliquots? 

12.9 What are the requirements for an 

initial drug test? 

12.10 What must an HHS-certified IITF do 

to validate an initial drug test? 

12.11 What are the batch quality control 

requirements when conducting an initial 

drug test? 

12.12 What are the analytical and quality 

control requirements for conducting 

specimen validity tests? 

12.13 What must an HHS-certified IITF do 

to validate a specimen validity test? 

12.14 What are the requirements for 

conducting each specimen validity test? 

12.15 What are the requirements for an 

HHS-certified IITF to report a test result? 

12.16 How does an HHS-certified IITF 

handle a specimen that tested positive, 

adulterated, substituted, or invalid at the 

IITF? 

12.17 How long must an HHS-certified IITF 

retain a specimen? 

12.18 How long must an HHS-certified IITF 

retain records? 

12.19 What statistical summary reports 

must an HHS-certified IITF provide? 

12.20 What HHS-certified IITF information 

is available to a Federal agency? 

12.21 What HHS-certified IITF information 

is available to a Federal employee? 

12.22 What types of relationships are 

prohibited between an HHS-certified 

IITF and an MRO? 

12.23 What type of relationship can exist 

between an HHS-certified IITF and an 

HHS-certified laboratory? 

Subpart M—Medical Review Officer (MRO) 

13.1 Who may serve as an MRO? 

13.2 How are nationally recognized entities 

or subspecialty boards that certify MROs 

approved? 

13.3 What training is required before a 

physician may serve as an MRO? 

13.4 What are the responsibilities of an 

MRO? 

13.5 What must an MRO do when 

reviewing a urine specimen’s test 

results? 

13.6 What action does the MRO take when 

the collector reports that the donor did 

not provide a sufficient amount of urine 

for a drug test? 

13.7 What happens when an individual is 

unable to provide a sufficient amount of 


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urine for a Federal agency applicant/preemployment test, a follow-up test, or a 

return-to-duty test because of a 

permanent or long-term medical 

condition? 

13.8 How does an MRO report a primary 

(A) specimen test result to an agency? 

13.9 Who may request a test of a split (B) 

specimen? 

13.10 What types of relationships are 

prohibited between an MRO and an 

HHS-certified laboratory or an HHScertified IITF? 

13.11 What reports must an MRO provide 

to the Secretary for urine testing? 

13.12 What are a Federal agency’s 

responsibilities for designating an MRO? 

Subpart N—Split Specimen Tests 

14.1 When may a split (B) specimen be 

tested? 

14.2 How does an HHS-certified laboratory 

test a split (B) specimen when the 

primary (A) specimen was reported 

positive? 

14.3 How does an HHS-certified laboratory 

test a split (B) urine specimen when the 

primary (A) specimen was reported 

adulterated? 

14.4 How does an HHS-certified laboratory 

test a split (B) urine specimen when the 

primary (A) specimen was reported 

substituted? 

14.5 Who receives the split (B) specimen 

result? 

14.6 What action(s) does an MRO take after 

receiving the split (B) urine specimen 

result from the second HHS-certified 

laboratory? 

14.7 How does an MRO report a split (B) 

specimen test result to an agency? 

14.8 How long must an HHS-certified 

laboratory retain a split (B) specimen? 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

15.1 What discrepancies require an HHScertified laboratory or an HHS-certified 

IITF to report a urine specimen as 

rejected for testing? 

15.2 What discrepancies require an HHScertified laboratory or an HHS-certified 

IITF to report a specimen as rejected for 

testing unless the discrepancy is 

corrected? 

15.3 What discrepancies are not sufficient 

to require an HHS-certified laboratory or 

an HHS-certified IITF to reject a urine 

specimen for testing or an MRO to cancel 

a test? 

15.4 What discrepancies may require an 

MRO to cancel a test? 

Subpart P—Laboratory or IITF Suspension/ 

Revocation Procedures 

16.1 When may the HHS certification of a 

laboratory or IITF be suspended? 

16.2 What definitions are used for this 

subpart? 

16.3 Are there any limitations on issues 

subject to review? 

16.4 Who represents the parties? 

16.5 When must a request for informal 

review be submitted? 

16.6 What is an abeyance agreement? 

16.7 What procedures are used to prepare 

the review file and written argument? 

16.8 When is there an opportunity for oral 

presentation? 

16.9 Are there expedited procedures for 

review of immediate suspension? 

16.10 Are any types of communications 

prohibited? 

16.11 How are communications transmitted 

by the reviewing official? 

16.12 What are the authority and 

responsibilities of the reviewing official? 

16.13 What administrative records are 

maintained? 

16.14 What are the requirements for a 

written decision? 

16.15 Is there a review of the final 

administrative action? 

Subpart A—Applicability 

Section 1.1 To whom do these 

Guidelines apply? 

(a) These Guidelines apply to: 

(1) Executive agencies as defined in 5 

U.S.C. 105; 

(2) The Uniformed Services, as 

defined in 5 U.S.C. 2101(3), but 

excluding the Armed Forces as defined 

in 5 U.S.C. 2101(2); 

(3) Any other employing unit or 

authority of the Federal Government 

except the United States Postal Service, 

the Postal Rate Commission, and 

employing units or authorities in the 

Judicial and Legislative Branches; and 

(4) The Intelligence Community, as 

defined by Executive Order 12333, is 

subject to these Guidelines only to the 

extent agreed to by the head of the 

affected agency; 

(5) Laboratories and instrumented 

initial test facilities (IITFs) that provide 

drug testing services to the Federal 

agencies; 

(6) Collectors who provide specimen 

collection services to the Federal 

agencies; and 

(7) Medical Review Officers (MROs) 

who provide drug testing review and 

interpretation of results services to the 

Federal agencies. 

(b) These Guidelines do not apply to 

drug testing under authority other than 

Executive Order 12564, including 

testing of persons in the criminal justice 

system, such as arrestees, detainees, 

probationers, incarcerated persons, or 

parolees. 

Section 1.2 Who is responsible for 

developing and implementing these 

Guidelines? 

(a) Executive Order 12564 and Public 

Law 100–71 require the Department of 

Health and Human Services (HHS) to 

establish scientific and technical 

guidelines for Federal workplace drug 

testing programs. 

(b) The Secretary has the 

responsibility to implement these 

Guidelines. 

Section 1.3 How does a Federal agency 

request a change from these Guidelines? 

(a) Each Federal agency must ensure 

that its workplace drug testing program 

complies with the provisions of these 

Guidelines unless a waiver has been 

obtained from the Secretary. 

(b) To obtain a waiver, a Federal 

agency must submit a written request to 

the Secretary that describes the specific 

change for which a waiver is sought and 

a detailed justification for the change. 

Section 1.4 How are these Guidelines 

revised? 

(a) To ensure the full reliability and 

accuracy of specimen tests, the accurate 

reporting of test results, and the 

integrity and efficacy of Federal drug 

testing programs, the Secretary may 

make changes to these Guidelines to 

reflect improvements in the available 

science and technology. 

(b) Revisions to these Guidelines will 

be published in final as a notification in 

the Federal Register. 

Section 1.5 What do the terms used in 

these Guidelines mean? 

The following definitions are adopted: 

Accessioner. The individual who 

signs the Federal Drug Testing Custody 

and Control Form at the time of 

specimen receipt at the HHS-certified 

laboratory or (for urine) the HHScertified IITF. 

Adulterated Specimen. A specimen 

that has been altered, as evidenced by 

test results showing either a substance 

that is not a normal constituent for that 

type of specimen or showing an 

abnormal concentration of a normal 

constituent (e.g., nitrite in urine). 

Aliquot. A portion of a specimen used 

for testing. 

Alternate Responsible Person. The 

person who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of the HHScertified laboratory when the 

responsible person is unable to fulfill 

these obligations. 

Alternate Responsible Technician. 

The person who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of the HHScertified IITF when the responsible 

technician is unable to fulfill these 

obligations. 

Alternate Technology Initial Drug 

Test. An initial drug test using 

technology other than immunoassay to 

differentiate negative specimens from 

those requiring further testing. 

Batch. A number of specimens or 

aliquots handled concurrently as a 

group. 


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Biomarker. An endogenous substance 

used to validate a biological specimen. 

Biomarker Testing Panel. The panel 

published in the Federal Register that 

includes the biomarkers authorized for 

testing, with analytes and cutoffs for 

initial and confirmatory biomarker tests, 

as described under Section 3.4. 

Blind Sample. A sample submitted to 

an HHS-certified test facility for quality 

assurance purposes, with a fictitious 

identifier, so that the test facility cannot 

distinguish it from a donor specimen. 

Calibrator. A sample of known 

content and analyte concentration 

prepared in the appropriate matrix used 

to define expected outcomes of a testing 

procedure. The test result of the 

calibrator is verified to be within 

established limits prior to use. 

Cancelled Test. The result reported by 

the MRO to the Federal agency when a 

specimen has been reported to the MRO 

as an invalid result (and the donor has 

no legitimate explanation) or the 

specimen has been rejected for testing, 

when a split specimen fails to 

reconfirm, or when the MRO determines 

that a fatal flaw or unrecovered 

correctable flaw exists in the forensic 

records (as described in Sections 15.1 

and 15.2). 

Carryover. The effect that occurs 

when a sample result (e.g., drug 

concentration) is affected by a preceding 

sample during the preparation or 

analysis of a sample. 

Certifying Scientist (CS). The 

individual responsible for verifying the 

chain of custody and scientific 

reliability of a test result reported by an 

HHS-certified laboratory. 

Certifying Technician (CT). The 

individual responsible for verifying the 

chain of custody and scientific 

reliability of negative, rejected for 

testing, and (for urine) negative/dilute 

results reported by an HHS-certified 

laboratory or (for urine) an HHScertified IITF. 

Chain of Custody (COC) Procedures. 

Procedures that document the integrity 

of each specimen or aliquot from the 

point of collection to final disposition. 

Chain of Custody Documents. Forms 

used to document the control and 

security of the specimen and all 

aliquots. The document may account for 

an individual specimen, aliquot, or 

batch of specimens/aliquots and must 

include the name and signature of each 

individual who handled the specimen(s) 

or aliquot(s) and the date and purpose 

of the handling. 

Collection Container. A receptacle 

used to collect a donor’s drug test 

specimen. 

Collection Site. The location where 

specimens are collected. 

Collector. A person trained to instruct 

and assist a donor in providing a 

specimen. 

Confirmatory Drug Test. A second 

analytical procedure performed on a 

separate aliquot of a specimen to 

identify and quantify a specific drug or 

drug metabolite. 

Confirmatory Specimen Validity Test. 

A second test performed on a separate 

aliquot of a specimen to further support 

an initial specimen validity test result. 

Control. A sample used to evaluate 

whether an analytical procedure or test 

is operating within predefined tolerance 

limits. 

Cutoff. The analytical value (e.g., 

drug, drug metabolite, or biomarker 

concentration) used as the decision 

point to determine a result (e.g., 

negative, positive, adulterated, invalid, 

or substituted) or the need for further 

testing. 

Dilute Specimen. A urine specimen 

with creatinine and specific gravity 

values that are lower than expected but 

are still within the physiologically 

producible ranges of human urine. 

Donor. The individual from whom a 

specimen is collected. 

Drug Testing Panel. The panel 

published in the Federal Register that 

includes the drugs authorized for 

testing, with analytes and cutoffs for 

initial and confirmatory drug tests, as 

described under Section 3.4. 

External Service Provider. An 

independent entity that performs 

services related to Federal workplace 

drug testing on behalf of a Federal 

agency, a collector/collection site, an 

HHS-certified laboratory, a Medical 

Review Officer (MRO), or (for urine) an 

HHS-certified Instrumented Initial Test 

Facility (IITF). 

Failed to Reconfirm. The result 

reported for a split (B) specimen when 

a second HHS-certified laboratory is 

unable to corroborate the result reported 

for the primary (A) specimen. 

Federal Drug Testing Custody and 

Control Form (Federal CCF). The Office 

of Management and Budget (OMB) 

approved form that is used to document 

the collection and chain of custody of a 

specimen from the time the specimen is 

collected until it is received by the test 

facility (i.e., HHS-certified laboratory or, 

for urine, HHS-certified IITF). It may be 

a paper (hardcopy), electronic (digital), 

or combination electronic and paper 

format (hybrid). The form may also be 

used to report the test result to the 

Medical Review Officer. 

Gender Identity. Gender identity 

means an individual’s internal sense of 

being male or female, which may be 

different from an individual’s sex 

assigned at birth. 

HHS. The Department of Health and 

Human Services. 

Initial Drug Test. An analysis used to 

differentiate negative specimens from 

those requiring further testing. 

Initial Specimen Validity Test. The 

first analysis used to determine if a 

specimen is adulterated, invalid, 

substituted, or (for urine) dilute. 

Instrumented Initial Test Facility 

(IITF). A permanent location where (for 

urine) initial testing, reporting of 

results, and recordkeeping are 

performed under the supervision of a 

responsible technician. 

Invalid Result. The result reported by 

an HHS-certified laboratory in 

accordance with the criteria established 

in Section 3.9 when a positive, negative, 

adulterated, or substituted result cannot 

be established for a specific drug or 

specimen validity test. 

Laboratory. A permanent location 

where initial and confirmatory drug 

testing, reporting of results, and 

recordkeeping are performed under the 

supervision of a responsible person. 

Limit of Detection (LOD). The lowest 

concentration at which the analyte (e.g., 

drug or drug metabolite) can be 

identified. 

Limit of Quantification (LOQ). For 

quantitative assays, the lowest 

concentration at which the identity and 

concentration of the analyte (e.g., drug 

or drug metabolite) can be accurately 

established. 

Lot. A number of units of an item 

(e.g., reagents, quality control material) 

manufactured from the same starting 

materials within a specified period of 

time for which the manufacturer 

ensures that the items have essentially 

the same performance characteristics 

and expiration date. 

Medical Review Officer (MRO). A 

licensed physician who reviews, 

verifies, and reports a specimen test 

result to the Federal agency. 

Negative Result. The result reported 

by an HHS-certified laboratory or (for 

urine) an HHS-certified IITF to an MRO 

when a specimen contains no drug and/ 

or drug metabolite; or the concentration 

of the drug or drug metabolite is less 

than the cutoff for that drug or drug 

class. 

Oral Fluid Specimen. An oral fluid 

specimen is collected from the donor’s 

oral cavity and is a combination of 

physiological fluids produced primarily 

by the salivary glands. 

Oxidizing Adulterant. A substance 

that acts alone or in combination with 

other substances to oxidize drug or drug 

metabolites to prevent the detection of 

the drugs or drug metabolites, or affects 

the reagents in either the initial or 

confirmatory drug test. 


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Performance Testing (PT) Sample. A 

program-generated sample sent to a 

laboratory or (for urine) to an IITF to 

evaluate performance. 

Positive Result. The result reported by 

an HHS-certified laboratory when a 

specimen contains a drug or drug 

metabolite equal to or greater than the 

confirmatory test cutoff. 

Reconfirmed. The result reported for 

a split (B) specimen when the second 

HHS-certified laboratory corroborates 

the original result reported for the 

primary (A) specimen. 

Rejected for Testing. The result 

reported by an HHS-certified laboratory 

or (for urine) HHS-certified IITF when 

no tests are performed on a specimen 

because of a fatal flaw or an 

unrecovered correctable error (see 

Sections 15.1 and 15.2). 

Responsible Person (RP). The person 

who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of an HHScertified laboratory. 

Responsible Technician (RT). The 

person who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of an HHScertified IITF. 

Sample. A performance testing 

sample, calibrator or control used 

during testing, or a representative 

portion of a donor’s specimen. 

Secretary. The Secretary of the U.S. 

Department of Health and Human 

Services. 

Specimen. Fluid or material collected 

from a donor at the collection site for 

the purpose of a drug test. 

Split Specimen Collection (for Urine). 

A collection in which the specimen 

collected is divided into a primary (A) 

specimen and a split (B) specimen, 

which are independently sealed in the 

presence of the donor. 

Standard. Reference material of 

known purity or a solution containing a 

reference material at a known 

concentration. 

Substituted Specimen. A specimen 

that has been submitted in place of the 

donor’s specimen, as evidenced by the 

absence of a biomarker or a biomarker 

concentration inconsistent with that 

established for a human specimen, as 

indicated in the biomarker testing panel, 

or (for urine) creatinine and specific 

gravity values that are outside the 

physiologically producible ranges of 

human urine, in accordance with the 

criteria to report a specimen as 

substituted in Section 3.7. 

Section 1.6 What is an agency required 

to do to protect employee records? 

Consistent with 5 U.S.C. 552a and 48 

CFR 24.101 through 24.104, all agency 

contracts with laboratories, IITFs, 

collectors, and MROs must require that 

they comply with the Privacy Act, 5 

U.S.C. 552a. In addition, the contracts 

must require compliance with employee 

access and confidentiality provisions of 

section 503 of Public Law 100–71. Each 

Federal agency must establish a Privacy 

Act System of Records or modify an 

existing system or use any applicable 

Government-wide system of records to 

cover the records of employee drug test 

results. All contracts and the Privacy 

Act System of Records must specifically 

require that employee records be 

maintained and used with the highest 

regard for employee privacy. 

The Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

Privacy Rule (Rule), 45 CFR parts 160 

and 164, subparts A and E, may be 

applicable to certain health care 

providers with whom a Federal agency 

may contract. If a health care provider 

is a HIPAA covered entity, the provider 

must protect the individually 

identifiable health information it 

maintains in accordance with the 

requirements of the Rule, which 

includes not using or disclosing the 

information except as permitted by the 

Rule and ensuring there are reasonable 

safeguards in place to protect the 

privacy of the information. For more 

information regarding the HIPAA 

Privacy Rule, please visit https://

www.hhs.gov/hipaa/index.html. 

Section 1.7 What is a refusal to take a 

federally regulated drug test? 

(a) As a donor for a federally regulated 

drug test, you have refused to take a 

federally regulated drug test if you: 

(1) Fail to appear for any test within 

a reasonable time, as determined by the 

Federal agency, consistent with 

applicable agency regulations, after 

being directed to do so by the Federal 

agency; 

(2) Fail to remain at the collection site 

until the collection process is complete; 

(3) Fail to provide a specimen (i.e., 

urine or another authorized specimen 

type) for any drug test required by these 

Guidelines or Federal agency 

regulations; 

(4) In the case of a direct observed or 

monitored collection, fail to permit the 

observation or monitoring of your 

provision of a specimen when required 

as described in Sections 8.9 and 8.10; 

(5) Fail to provide a sufficient amount 

of urine when directed, and it has been 

determined, through a required medical 

evaluation, that there was no legitimate 

medical explanation for the failure as 

determined by the process described in 

Section 13.6; 

(6) Fail or decline to participate in an 

alternate specimen collection (e.g., oral 

fluid) as directed by the Federal agency 

or collector (i.e., as described in Section 

8.6); 

(7) Fail to undergo a medical 

examination or evaluation, as directed 

by the MRO as part of the verification 

process (i.e., Section 13.6) or as directed 

by the Federal agency. In the case of a 

Federal agency applicant/preemployment drug test, the donor is 

deemed to have refused to test on this 

basis only if the Federal agency 

applicant/pre-employment test is 

conducted following a contingent offer 

of employment. If there was no 

contingent offer of employment, the 

MRO will cancel the test; 

(8) Fail to cooperate with any part of 

the testing process (e.g., refuse to empty 

pockets when directed by the collector, 

disrupt the collection process, fail to 

wash hands after being directed to do so 

by the collector); 

(9) For an observed collection, fail to 

follow the observer’s instructions 

related to the collection process; 

(10) Bring materials to the collection 

site for the purpose of adulterating, 

substituting, or diluting the specimen; 

(11) Attempt to adulterate, substitute, 

or dilute the specimen; 

(12) Possess or wear a prosthetic or 

other device that could be used to 

interfere with the collection process; or 

(13) Admit to the collector or MRO 

that you have adulterated or substituted 

the specimen. 

Section 1.8 What are the potential 

consequences for refusing to take a 

federally regulated drug test? 

(a) A refusal to take a test may result 

in the initiation of disciplinary or 

adverse action for a Federal employee, 

up to and including removal from 

Federal employment. An applicant’s 

refusal to take a pre-employment test 

may result in non-selection for Federal 

employment. 

(b) When a donor has refused to 

participate in a part of the collection 

process, including failing to appear in a 

reasonable time for any test, the 

collector must terminate the collection 

process and take action as described in 

Section 8.13. Required action includes 

immediately notifying the Federal 

agency’s designated representative by 

any means (e.g., telephone, email, or 

secure facsimile [fax] machine) that 

ensures that the refusal notification is 

immediately received and, if a Federal 

CCF has been initiated, documenting 


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the refusal on the Federal CCF, signing 

and dating the Federal CCF, and 

sending all copies of the Federal CCF to 

the Federal agency’s designated 

representative. 

(c) When documenting a refusal to 

test during the verification process as 

described in Sections 13.4, 13.5, and 

13.6, the MRO must complete the MRO 

copy of the Federal CCF to include: 

(1) Checking the refusal to test box; 

(2) Providing a reason for the refusal 

in the remarks line; and 

(3) Signing and dating the MRO copy 

of the Federal CCF. 

Subpart B—Urine Specimens 

Section 2.1 What type of specimen 

may be collected? 

A Federal agency may collect urine 

and/or an alternate specimen type for its 

workplace drug testing program. Only 

specimen types authorized by 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs may 

be collected. An agency using urine 

must follow these Guidelines. 

Section 2.2 Under what circumstances 

may a urine specimen be collected? 

A Federal agency may collect a urine 

specimen for the following reasons: 

(a) Federal agency applicant/Preemployment test; 

(b) Random test; 

(c) Reasonable suspicion/cause test; 

(d) Post accident test; 

(e) Return to duty test; or 

(f) Follow-up test. 

Section 2.3 How is each urine 

specimen collected? 

Each urine specimen is collected as a 

split specimen as described in Section 

2.5. 

Section 2.4 What volume of urine is 

collected? 

A donor is expected to provide at 

least 45 mL of urine for a specimen. 

Section 2.5 How does the collector 

split the urine specimen? 

The collector pours at least 30 mL 

into a specimen bottle that is designated 

as A (primary) and then pours at least 

15 mL into a specimen bottle that is 

designated as B (split). 

Section 2.6 When may an entity or 

individual release a urine specimen? 

Entities and individuals subject to 

these Guidelines under Section 1.1 may 

not release specimens collected 

pursuant to Executive Order 12564, 

Public Law 100–71, and these 

Guidelines to donors or their designees. 

Specimens also may not be released to 

any other entity or individual unless 

expressly authorized by these 

Guidelines or by applicable Federal law. 

This section does not prohibit a donor’s 

request to have a split (B) specimen 

tested in accordance with Section 13.9. 

Subpart C—Urine Specimen Tests 

Section 3.1 Which tests are conducted 

on a urine specimen? 

A Federal agency: 

(a) Must ensure that each specimen is 

tested for marijuana and cocaine 

metabolites as provided in the drug 

testing panel described under Section 

3.4; 

(b) Is authorized to test each specimen 

for other Schedule I or II drugs as 

provided in the drug testing panel; 

(c) Must ensure that the following 

specimen validity tests are conducted 

on each urine specimen: 

(1) Determine the creatinine 

concentration on every specimen; 

(2) Determine the specific gravity on 

every specimen for which the creatinine 

concentration is less than 20 mg/dL; 

(3) Determine the pH on every 

specimen; and 

(4) Perform one or more specimen 

validity tests for oxidizing adulterants 

on every specimen. 

(d) Is authorized to test each specimen 

for one or more biomarkers as provided 

in the biomarker testing panel; and 

(e) May perform additional testing if 

a specimen exhibits abnormal 

characteristics (e.g., unusual odor or 

color, semi-solid characteristics), causes 

reactions or responses characteristic of 

an adulterant during initial or 

confirmatory drug tests (e.g., nonrecovery of internal standard, unusual 

response), or contains an unidentified 

substance that interferes with the 

confirmatory analysis. 

Section 3.2 May a specimen be tested 

for drugs other than those in the drug 

testing panel? 

(a) On a case-by-case basis, a 

specimen may be tested for additional 

drugs, if a Federal agency is conducting 

the collection for reasonable suspicion 

or post accident testing. A specimen 

collected from a Federal agency 

employee may be tested by the Federal 

agency for any drugs listed in Schedule 

I or II of the Controlled Substances Act. 

The Federal agency must request the 

HHS-certified laboratory to test for the 

additional drug, include a justification 

to test a specific specimen for the drug, 

and ensure that the HHS-certified 

laboratory has the capability to test for 

the drug and has established properly 

validated initial and confirmatory 

analytical methods. If an initial test 

procedure is not available upon request 

for a suspected Schedule I or Schedule 

II drug, the Federal agency can request 

an HHS-certified laboratory to test for 

the drug by analyzing two separate 

aliquots of the specimen in two separate 

testing batches using the confirmatory 

analytical method. Additionally, the 

split (B) specimen will be available for 

testing if the donor requests a retest at 

another HHS-certified laboratory. 

(b) A Federal agency covered by these 

Guidelines must petition the Secretary 

in writing for approval to routinely test 

for any drug class not listed in the drug 

testing panel described under Section 

3.4. Such approval must be limited to 

the use of the appropriate science and 

technology and must not otherwise limit 

agency discretion to test for any drug 

tested under Section 3.2(a). 

Section 3.3 May any of the specimens 

be used for other purposes? 

(a) Specimens collected pursuant to 

Executive Order 12564, Public Law 

100–71, and these Guidelines must only 

be tested for drugs and to determine 

their validity in accordance with 

subpart C of these Guidelines. Use of 

specimens by donors, their designees, or 

any other entity, for other purposes (e.g., 

deoxyribonucleic acid, DNA, testing) is 

prohibited unless authorized in 

accordance with applicable Federal law. 

(b) These Guidelines are not intended 

to prohibit Federal agencies specifically 

authorized by law to test a specimen for 

additional classes of drugs in its 

workplace drug testing program. 

Section 3.4 What are the drug and 

biomarker test analytes and cutoffs for 

urine? 

The Secretary will publish the drug 

and biomarker test analytes and cutoffs 

(i.e., the ‘‘drug testing panel’’ and 

‘‘biomarker testing panel’’) for initial 

and confirmatory drug and biomarker 

tests in the Federal Register each year. 

The drug and biomarker testing panels 

will also be available on the internet at 

https://www.samhsa.gov/workplace. 

This drug testing panel will remain in 

effect until the effective date of a new 

drug testing panel published in the 

Federal Register: 


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

Marijuana metabolite (THCA) 2 ........................................ 50 ng/mL3 .......................... THCA ................................. 15 ng/mL. 

Cocaine metabolite (Benzoylecgonine) ........................... 150 ng/mL3 ........................ Benzoylecgonine ............... 100 ng/mL. 

Codeine/Morphine ........................................................... 2000 ng/mL ....................... Codeine .............................

Morphine ............................

2000 ng/mL. 

4000 ng/mL. 

Hydrocodone/Hydromorphone ......................................... 300 ng/mL ......................... Hydrocodone .....................

Hydromorphone .................

100 ng/mL. 

100 ng/mL. 

Oxycodone/Oxymorphone ............................................... 100 ng/mL ......................... Oxycodone ........................

Oxymorphone ....................

100 ng/mL. 

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 ....................

Methamphetamine .............

250 ng/mL. 

250 ng/mL. 

MDMA4/MDA5 ................................................................. 500 ng/mL ......................... MDMA ................................

MDA ...................................

250 ng/mL. 

250 ng/mL. 

1For 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. 2An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 3Alternate 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). 4Methylenedioxymethamphetamine (MDMA). 

5Methylenedioxyamphetamine (MDA). 

(a) The drug testing panel will include 

drugs authorized for testing in Federal 

workplace drug testing programs, with 

the required test analytes and cutoffs; 

(b) The biomarker testing panel will 

include biomarkers authorized for 

testing in Federal workplace drug 

testing programs, with the required test 

analytes and cutoffs; and 

(c) HHS-certified IITFs, HHS-certified 

laboratories, and Medical Review 

Officers must use the nomenclature (i.e., 

analyte names and abbreviations) 

published in the Federal Register with 

the drug and biomarker testing panels to 

report Federal workplace drug test 

results. 

Section 3.5 May an HHS-certified 

laboratory perform additional drug and/ 

or specimen validity tests on a specimen 

at the request of the Medical Review 

Officer (MRO)? 

An HHS-certified laboratory is 

authorized to perform additional drug 

and/or specimen validity tests on a caseby-case basis as necessary to provide 

information that the MRO would use to 

report a verified drug test result (e.g., 

tetrahydrocannabivarin, specimen 

validity tests). An HHS-certified 

laboratory is not authorized to routinely 

perform additional drug and/or 

specimen validity tests at the request of 

an MRO without prior authorization 

from the Secretary or designated HHS 

representative, with the exception of the 

determination of d,l stereoisomers of 

amphetamine and methamphetamine. 

All tests must meet appropriate 

validation and quality control 

requirements in accordance with these 

Guidelines. 

Section 3.6 What criteria are used to 

report a urine specimen as adulterated? 

An HHS-certified laboratory reports a 

primary (A) specimen as adulterated 

when: 

(a) The pH is less than 4 or equal to 

or greater than 11 using either a pH 

meter or a colorimetric pH test for the 

initial test on the first aliquot and a pH 

meter for the confirmatory test on the 

second aliquot; 

(b) The nitrite concentration is equal 

to or greater than 500 mcg/mL using 

either a nitrite colorimetric test or a 

general oxidant colorimetric test for the 

initial test on the first aliquot and a 

different confirmatory test (e.g., multiwavelength spectrophotometry, ion 

chromatography, capillary 

electrophoresis) on the second aliquot; 

(c) The presence of chromium (VI) is 

verified using either a general oxidant 

colorimetric test (with an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or a chromium (VI) 

colorimetric test (chromium (VI) 

concentration equal to or greater than 50 

mcg/mL) for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., multi-wavelength 

spectrophotometry, ion 

chromatography, atomic absorption 

spectrophotometry, capillary 

electrophoresis, inductively coupled 

plasma-mass spectrometry) with the 

chromium (VI) concentration equal to or 

greater than the LOQ of the 

confirmatory test on the second aliquot; 

(d) The presence of a halogen (e.g., 

chlorine from bleach, iodine, fluoride) is 

verified using either a general oxidant 

colorimetric test (with an equal to or 

great than 200 mcg/mL nitriteequivalent cutoff or an equal to or great 

than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or halogen 

colorimetric test (halogen concentration 

equal to or greater than the LOQ) for the 

initial test on the first aliquot and a 

different confirmatory test (e.g., multiwavelength spectrophotometry, ion 

chromatography, inductively coupled 

plasma-mass spectrometry) with a 

specific halogen concentration equal to 

or greater than the LOQ of the 

confirmatory test on the second aliquot; 

(e) The presence of glutaraldehyde is 

verified using either an aldehyde test 

(aldehyde present) or the characteristic 

immunoassay response on one or more 

drug immunoassay tests for the initial 

test on the first aliquot and a different 

confirmatory test (e.g., GC/MS) for the 

confirmatory test with the 

glutaraldehyde concentration equal to or 

greater than the LOQ of the analysis on 

the second aliquot; 

(f) The presence of pyridine 

(pyridinium chlorochromate) is verified 

using either a general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or a chromium (VI) 

colorimetric test (chromium (VI) 

concentration equal to or greater than 50 

mcg/mL) for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., GC/MS) for the confirmatory test 

with the pyridine concentration equal to 

or greater than the LOQ of the analysis 

on the second aliquot; 


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(g) The presence of a surfactant is 

verified by using a surfactant 

colorimetric test with an equal to or 

greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., multi-wavelength 

spectrophotometry) with an equal to or 

greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff on the second aliquot; or 

(h) The presence of any other 

adulterant not specified in paragraphs 

(b) through (g) of this section is verified 

using an initial test on the first aliquot 

and a different confirmatory test on the 

second aliquot. 

Section 3.7 What criteria are used to 

report a urine specimen as substituted? 

An HHS-certified laboratory reports a 

primary (A) specimen as substituted 

when: 

(a) The creatinine concentration is 

less than 2 mg/dL on both the initial 

and confirmatory creatinine tests on two 

separate aliquots (i.e., the same 

colorimetric test may be used to test 

both aliquots) and the specific gravity is 

less than or equal to 1.0010 or equal to 

or greater than 1.0200 on both the initial 

and confirmatory specific gravity tests 

on two separate aliquots (i.e., a 

refractometer is used to test both 

aliquots), or 

(b) A biomarker is not detected or is 

present at a concentration inconsistent 

with that established for human urine 

for both the initial (first) test and the 

confirmatory (second) test on two 

separate aliquots (i.e., using the test 

analytes and cutoffs listed in the 

biomarker testing panel). 

Section 3.8 What criteria are used to 

report a urine specimen as dilute? 

A dilute result may be reported only 

in conjunction with the positive or 

negative drug test results for a 

specimen. 

(a) An HHS-certified laboratory or an 

HHS-certified IITF reports a primary (A) 

specimen as dilute when the creatinine 

concentration is greater than 5 mg/dL 

but less than 20 mg/dL and the specific 

gravity is equal to or greater than 1.002 

but less than 1.003 on a single aliquot. 

(b) In addition, an HHS-certified 

laboratory reports a primary (A) 

specimen as dilute when the creatinine 

concentration is equal to or greater than 

2 mg/dL but less than 20 mg/dL and the 

specific gravity is greater than 1.0010 

but less than 1.0030. 

Section 3.9 What criteria are used to 

report an invalid result for a urine 

specimen? 

An HHS-certified laboratory reports a 

primary (A) specimen as an invalid 

result when: 

(a) Inconsistent creatinine 

concentration and specific gravity 

results are obtained (i.e., the creatinine 

concentration is less than 2 mg/dL on 

both the initial and confirmatory 

creatinine tests and the specific gravity 

is greater than 1.0010 but less than 

1.0200 on the initial and/or 

confirmatory specific gravity test, the 

specific gravity is less than or equal to 

1.0010 on both the initial and 

confirmatory specific gravity tests and 

the creatinine concentration is equal to 

or greater than 2 mg/dL on either or 

both the initial or confirmatory 

creatinine tests); 

(b) The pH is equal to or greater than 

4 and less than 4.5 or equal to or greater 

than 9 and less than 11 using either a 

colorimetric pH test or pH meter for the 

initial test and a pH meter for the 

confirmatory test on two separate 

aliquots; 

(c) The nitrite concentration is equal 

to or greater than 200 mcg/mL using a 

nitrite colorimetric test or equal to or 

greater than the equivalent of 200 mcg/ 

mL nitrite using a general oxidant 

colorimetric test for both the initial 

(first) test and the second test or using 

either initial test and the nitrite 

concentration is equal to or greater than 

200 mcg/mL but less than 500 mcg/mL 

for a different confirmatory test (e.g., 

multi-wavelength spectrophotometry, 

ion chromatography, capillary 

electrophoresis) on two separate 

aliquots; 

(d) The possible presence of 

chromium (VI) is determined using the 

same chromium (VI) colorimetric test 

with a cutoff equal to or greater than 50 

mcg/mL chromium (VI) for both the 

initial (first) test and the second test on 

two separate aliquots; 

(e) The possible presence of a halogen 

(e.g., chlorine from bleach, iodine, 

fluoride) is determined using the same 

halogen colorimetric test with a cutoff 

equal to or greater than the LOQ for both 

the initial (first) test and the second test 

on two separate aliquots or relying on 

the odor of the specimen as the initial 

test; 

(f) The possible presence of 

glutaraldehyde is determined by using 

the same aldehyde test (aldehyde 

present) or characteristic immunoassay 

response on one or more drug 

immunoassay tests for both the initial 

(first) test and the second test on two 

separate aliquots; 

(g) The possible presence of an 

oxidizing adulterant is determined by 

using the same general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent cutoff, an equal to or greater 

than 50 mcg/mL chromium (VI)- 

equivalent cutoff, or a halogen 

concentration is equal to or greater than 

the LOQ) for both the initial (first) test 

and the second test on two separate 

aliquots; 

(h) The possible presence of a 

surfactant is determined by using the 

same surfactant colorimetric test with 

an equal to greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff for both the initial (first) test and 

the second test on two separate aliquots 

or a foam/shake test for the initial test; 

(i) Interference occurs on the initial 

drug tests on two separate aliquots (i.e., 

valid initial drug test results cannot be 

obtained); 

(j) Interference with the confirmatory 

drug test occurs on two separate 

aliquots of the specimen and the 

laboratory is unable to identify the 

interfering substance; 

(k) The physical appearance of the 

specimen (e.g., viscosity) is such that 

testing the specimen may damage the 

laboratory’s instruments; 

(l) The specimen has been tested and 

the appearances of the primary (A) and 

the split (B) specimens (e.g., color) are 

clearly different; or 

(m) A specimen validity test (i.e., 

other than the tests listed above) on two 

separate aliquots of the specimen 

indicates that the specimen is not valid 

for testing. 

Subpart D—Collectors 

Section 4.1 Who may collect a 

specimen? 

(a) A collector who has been trained 

to collect urine specimens in 

accordance with these Guidelines. 

(b) The immediate supervisor of a 

Federal employee donor may only 

collect that donor’s specimen when no 

other collector is available. The 

supervisor must be a trained collector. 

(c) The hiring official of a Federal 

agency applicant may only collect that 

Federal agency applicant’s specimen 

when no other collector is available. 

The hiring official must be a trained 

collector. 

Section 4.2 Who may not collect a 

specimen? 

(a) A Federal agency employee who is 

in a testing designated position and 

subject to the Federal agency drug 

testing rules must not be a collector for 

co-workers in the same testing pool or 


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who work with that employee on a daily 

basis. 

(b) A Federal agency applicant or 

employee must not collect their own 

drug testing specimen. 

(c) An employee working for an HHScertified laboratory or IITF must not act 

as a collector if the employee could link 

the identity of the donor to the donor’s 

drug test result. 

(d) To avoid a potential conflict of 

interest, a collector must not be related 

to the employee (e.g., spouse, ex-spouse, 

relative) or be a personal friend of the 

employee (e.g., fiance ́e). 

Section 4.3 What are the requirements 

to be a collector? 

(a) An individual may serve as a 

collector if they fulfill the following 

conditions: 

(1) Is knowledgeable about the 

collection procedure described in these 

Guidelines; 

(2) Is knowledgeable about any 

guidance provided by the Federal 

agency’s Drug-Free Workplace Program 

and additional information provided by 

the Secretary relating to the collection 

procedure described in these 

Guidelines; 

(3) Is trained and qualified to collect 

a urine specimen. Training must 

include the following: 

(i) All steps necessary to complete a 

urine collection; 

(ii) Completion and distribution of the 

Federal CCF; 

(iii) Problem collections; 

(iv) Fatal flaws, correctable flaws, and 

how to correct problems in collections; 

and 

(v) The collector’s responsibility for 

maintaining the integrity of the 

collection process, ensuring the privacy 

of the donor, ensuring the security of 

the specimen, and avoiding conduct or 

statements that could be viewed as 

offensive or inappropriate. 

(4) Has demonstrated proficiency in 

collections by completing five 

consecutive error-free mock collections. 

(i) The five mock collections must 

include one uneventful collection 

scenario, one insufficient specimen 

quantity scenario, one temperature out 

of range scenario, one scenario in which 

the donor refuses to sign the Federal 

CCF, and one scenario in which the 

donor refuses to initial the specimen 

bottle tamper-evident seal. 

(ii) A qualified trainer for collectors 

must monitor and evaluate the 

individual being trained, in person or by 

a means that provides real-time 

observation and interaction between the 

trainer and the trainee, and the trainer 

must attest in writing that the mock 

collections are error-free. 

(b) A trained collector must complete 

refresher training at least every five 

years that includes the requirements in 

Section 4.3(a). 

(c) The collector must maintain the 

documentation of their training and 

provide that documentation to a Federal 

agency when requested. 

(d) An individual may not collect 

specimens for a Federal agency until the 

individual’s training as a collector has 

been properly documented. 

Section 4.4 What are the requirements 

to be an observer for a direct observed 

collection? 

(a) An individual may serve as an 

observer for a direct observed collection 

when the individual has satisfied the 

requirements: 

(1) Is knowledgeable about the direct 

observed collection procedure described 

in Section 8.9; 

(2) Is knowledgeable about any 

guidance provided by the Federal 

agency’s Drug-Free Workplace Program 

or additional information provided by 

the Secretary relating to the direct 

observed collection procedure described 

in these Guidelines; 

(3) Has received training on the 

following subjects: 

(i) All steps necessary to perform a 

direct observed collection; and 

(ii) The observer’s responsibility for 

maintaining the integrity of the 

collection process, ensuring the privacy 

of individuals being tested, ensuring 

that the observation is done in a 

professional manner that minimizes the 

discomfort to the employee so observed, 

ensuring the security of the specimen by 

maintaining visual contact with the 

collection container until it is delivered 

to the collector, and avoiding conduct or 

statements that could be viewed as 

offensive or inappropriate. 

(b) The gender of the observer must be 

the same as the donor’s gender, which 

is determined by the donor’s gender 

identity. The observer selection process 

is described in Section 8.10(b). 

(c) The observer is not required to be 

a trained collector. 

Section 4.5 What are the requirements 

to be a trainer for collectors? 

(a) Individuals are considered 

qualified trainers for collectors and may 

train others to collect urine specimens 

when they have completed the 

following: 

(1) Qualified as a trained collector and 

regularly conducted urine drug test 

collections for a period of at least one 

year; or 

(2) Completed a ‘‘train the trainer’’ 

course given by an organization (e.g., 

manufacturer, private entity, contractor, 

Federal agency). 

(b) A qualified trainer for collectors 

must complete refresher training at least 

every five years in accordance with the 

collector requirements in Section 4.3(a). 

(c) A qualified trainer for collectors 

must maintain the documentation of the 

trainer’s training and provide that 

documentation to a Federal agency 

when requested. 

Section 4.6 What must a Federal 

agency do before a collector is permitted 

to collect a specimen? 

A Federal agency must ensure the 

following: 

(a) The collector has satisfied the 

requirements described in Section 4.3; 

(b) The collector, who may be selfemployed, or an organization (e.g., third 

party administrator that provides a 

collection service, collector training 

company, Federal agency that employs 

its own collectors) maintains a copy of 

the training record(s); and 

(c) The collector has been provided 

the name and telephone number of the 

Federal agency representative. 

Subpart E—Collection Sites 

Section 5.1 Where can a collection for 

a drug test take place? 

(a) A collection site may be a 

permanent or temporary facility located 

either at the work site or at a remote 

site. 

(b) In the event that an agencydesignated collection site is not 

accessible and there is an immediate 

requirement to collect a urine specimen 

(e.g., an accident investigation), a public 

restroom may be used for the collection, 

using the procedures for a monitored 

collection described in Section 8.12. 

Section 5.2 What are the requirements 

for a collection site? 

The facility used as a collection site 

must have the following: 

(a) Provisions to ensure donor privacy 

during the collection (as described in 

Section 8.1); 

(b) A suitable and clean surface area 

that is not accessible to the donor for 

handling the specimens and completing 

the required paperwork; 

(c) A secure temporary storage area to 

maintain specimens until the specimen 

is transferred to an HHS-certified 

laboratory or IITF; 

(d) A restricted access area where 

only authorized personnel may be 

present during the collection; 

(e) A restricted access area for the 

storage of collection supplies; 

(f) A restricted access area for the 

secure storage of records; and 

(g) The ability to restrict the donor 

access to potential diluents in 

accordance with Section 8.2. 


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Section 5.3 Where must collection site 

records be stored? 

Collection site records must be stored 

at a secure site designated by the 

collector or the collector’s employer. 

Section 5.4 How long must collection 

site records be stored? 

Collection site records (e.g., collector 

copies of the OMB-approved Federal 

CCF) must be stored securely for a 

minimum of 2 years. The collection site 

may convert hardcopy records to 

electronic records for storage and 

discard the hardcopy records after 6 

months. 

Section 5.5 How does the collector 

ensure the security and integrity of a 

specimen at the collection site? 

(a) A collector must do the following 

to maintain the security and integrity of 

a specimen: 

(1) Not allow unauthorized personnel 

to enter the collection area during the 

collection procedure; 

(2) Perform only one donor collection 

at a time; 

(3) Restrict access to collection 

supplies before, during, and after 

collection; 

(4) Ensure that only the collector and 

the donor are allowed to handle the 

unsealed specimen; 

(5) Ensure the chain of custody 

process is maintained and documented 

throughout the entire collection, storage, 

and transport procedures; 

(6) Ensure that the Federal CCF is 

completed and distributed as required; 

and 

(7) Ensure that specimens transported 

to an HHS-certified laboratory or IITF 

are sealed and placed in transport 

containers designed to minimize the 

possibility of damage during shipment 

(e.g., specimen boxes, padded mailers, 

or other suitable shipping container), 

and those containers are securely sealed 

to eliminate the possibility of 

undetected tampering; 

(b) Couriers, express carriers, and 

postal service personnel are not 

required to document chain of custody 

since specimens are sealed in packages 

that would indicate tampering during 

transit to the HHS-certified laboratory or 

IITF. 

Section 5.6 What are the privacy 

requirements when collecting a urine 

specimen? 

Collections must be performed at a 

site that provides reasonable privacy (as 

described in Section 8.1). 

Subpart F—Federal Drug Testing 

Custody and Control Form 

Section 6.1 What Federal form is used 

to document custody and control? 

The OMB-approved Federal CCF must 

be used to document custody and 

control of each specimen at the 

collection site. 

Section 6.2 What happens if the 

correct OMB-approved Federal CCF is 

not available or is not used? 

(a) The use of a non-Federal CCF or 

an expired Federal CCF is not, by itself, 

a reason for the HHS-certified laboratory 

or IITF to automatically reject the 

specimen for testing or for the MRO to 

cancel the test. 

(b) If the collector does not use the 

correct OMB-approved Federal CCF, the 

collector must document that it is a 

Federal agency specimen collection and 

provide the reason that the incorrect 

form was used. Based on the 

information provided by the collector, 

the HHS-certified laboratory or IITF 

must handle and test the specimen as a 

Federal agency specimen. 

(c) If the HHS-certified laboratory, 

HHS-certified IITF, or MRO discovers 

that the collector used an incorrect 

form, the laboratory, IITF, or MRO must 

obtain a memorandum for the record 

from the collector describing the reason 

the incorrect form was used. If a 

memorandum for the record cannot be 

obtained, the laboratory or IITF reports 

a rejected for testing result to the MRO 

and the MRO cancels the test. The HHScertified laboratory or IITF must wait at 

least 5 business days while attempting 

to obtain the memorandum before 

reporting a rejected for testing result to 

the MRO. 

Subpart G—Urine Specimen Collection 

Containers and Bottles 

Section 7.1 What is used to collect a 

urine specimen? 

A single-use collection container with 

a means (i.e., thermometer) to measure 

urine temperature and two specimen 

bottles must be used. 

Section 7.2 What are the requirements 

for a urine collection container and 

specimen bottles? 

(a) The collection container, the 

thermometer, and the specimen bottles 

must not substantially affect the 

composition of drugs and/or metabolites 

in the urine specimen. 

(b) The two specimen bottles must be 

sealable and non-leaking, and must 

maintain the integrity of the specimen 

during storage and transport so that the 

specimen contained therein can be 

tested in an HHS-certified laboratory or 

IITF for the presence of drugs or their 

metabolites. 

(c) The two specimen bottles must be 

sufficiently transparent (e.g., 

translucent) to enable an objective 

assessment of specimen appearance and 

identification of abnormal physical 

characteristics without opening the 

bottle. 

Section 7.3 What are the minimum 

performance requirements for a urine 

collection container and specimen 

bottles? 

(a) The collection container must be 

capable of holding at least 55 mL and 

have a volume marking clearly noting a 

level of 45 mL. 

(b) One of the two specimen bottles 

must be capable of holding at least 35 

mL and the other at least 20 mL, and 

each must have a volume marking 

clearly noting the appropriate level (30 

mL for the primary specimen and 15 mL 

for the split specimen). 

(c) The thermometer may be affixed to 

or built into the collection container and 

must provide graduated temperature 

readings from 32–38 °C/90–100 °F. 

Alternatively, the collector may use 

another technology to measure 

specimen temperature (e.g., thermal 

radiation scanning), providing the 

thermometer does not come into contact 

with the specimen. 

Subpart H—Urine Specimen Collection 

Procedure 

Section 8.1 What privacy must the 

donor be given when providing a urine 

specimen? 

The following privacy requirements 

apply when a donor is providing a urine 

specimen: 

(a) Only authorized personnel and the 

donor may be present in the restricted 

access area where the collection takes 

place. 

(b) The collector is not required to be 

the same gender as the donor. The 

gender of the observer for purposes of a 

direct observed collection (i.e., as 

described in Section 8.10) must be the 

same as the donor’s gender, which is 

determined by the donor’s gender 

identity. The gender of the monitor for 

a monitored collection (i.e., as described 

in Section 8.12) must be the same as the 

donor’s gender, unless the monitor is a 

medical professional (e.g., nurse, doctor, 

physician’s assistant, technologist, or 

technician licensed or certified to 

practice in the jurisdiction in which the 

collection takes place). 

(c) The collector must give the donor 

visual privacy while providing the 

specimen. The donor is allowed to 

provide a urine specimen in an enclosed 


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stall within a multi-stall restroom or in 

a single person restroom during a 

monitored collection. 

Section 8.2 What must the collector 

ensure at the collection site before 

starting a urine specimen collection? 

The collector must deter the dilution 

or substitution of a specimen at the 

collection site by: 

(a) Placing a toilet bluing agent in a 

toilet bowl or toilet tank, so the 

reservoir of water in the toilet bowl 

always remains blue. If no bluing agent 

is available or if the toilet has an 

automatic flushing system, the collector 

shall turn the water supply off to the 

toilet and flush the toilet to remove the 

water in the toilet when possible. 

(b) Secure other sources of water (e.g., 

shower or sink) in the enclosure where 

urination occurs. If the enclosure has a 

source of water that cannot be disabled 

or secured, a monitored collection must 

be conducted in accordance with 

Section 8.11. 

Section 8.3 What are the preliminary 

steps in the urine specimen collection 

procedure? 

The collector must take the following 

steps before beginning a urine specimen 

collection: 

(a) If a donor fails to arrive at the 

collection site at the assigned time, the 

collector must follow the Federal agency 

policy or contact the Federal agency 

representative to obtain guidance on 

action to be taken. 

(b) When the donor arrives at the 

collection site, the collector should 

begin the collection procedure without 

undue delay. For example, the 

collection should not be delayed 

because the donor states that they are 

unable to urinate or an authorized 

employer or employer representative is 

late in arriving. 

(c) The collector requests the donor to 

present photo identification (e.g., 

driver’s license; employee badge issued 

by the employer; an alternative photo 

identification issued by a Federal, state, 

or local government agency). If the 

donor does not have proper photo 

identification, the collector shall contact 

the supervisor of the donor or the 

Federal agency representative who can 

positively identify the donor. If the 

donor’s identity cannot be established, 

the collector must not proceed with the 

collection. 

(d) The collector must provide 

identification (e.g., employee badge, 

employee list) if requested by the donor. 

(e) The collector explains the basic 

collection procedure to the donor. 

(f) The collector provides the 

instructions for completing the Federal 

CCF for the donor’s review, and informs 

the donor that the instructions are 

available upon request. 

(g) The collector answers any 

reasonable and appropriate questions 

the donor may have regarding the 

collection procedure. 

(h) The collector asks the donor to 

remove any unnecessary outer garments 

(e.g., coat, jacket) that might conceal 

items or substances that could be used 

to adulterate or substitute the urine 

specimen. The collector must ensure 

that all personal belongings (e.g., purse 

or briefcase) remain with the outer 

garments. The donor may retain the 

donor’s wallet. The donor is not 

required to remove any items worn for 

faith-based reasons. 

(i) The collector asks the donor to 

empty the donor’s pockets and display 

the contents to ensure no items are 

present that could be used to adulterate 

or substitute the specimen. 

(1) If no items are present that can be 

used to adulterate, substitute, or dilute 

the specimen, the collector instructs the 

donor to return the items to their 

pockets and continues the collection 

procedure. 

(2) If an item is present whose 

purpose is to adulterate, substitute, or 

dilute the specimen (e.g., a commercial 

drug culture product or other substance 

for which the donor has no reasonable 

explanation), this is considered a refusal 

to test. The collector must stop the 

collection and report the refusal to test 

as described in Section 8.13. 

(3) If an item that could be used to 

adulterate, substitute, or dilute the 

specimen (e.g., common personal care 

products such as eyedrops, mouthwash, 

or hand sanitizer) appears to have been 

inadvertently brought to the collection 

site, the collector must secure the item 

and continue with the normal collection 

procedure. 

(4) If the donor refuses to show the 

collector the items in their pockets, this 

is considered a refusal to test. The 

collector must stop the collection and 

report the refusal to test as described in 

Section 8.13. 

(j) The collector shall instruct the 

donor to wash and dry the donor’s 

hands prior to urination. After washing 

the donor’s hands, the donor must 

remain in the presence of the collector 

and must not have access to any water 

fountain, faucet, soap dispenser, 

cleaning agent, or any other materials 

which could be used to adulterate or 

substitute the specimen. 

(k) If the donor refuses to wash their 

hands when instructed by the collector, 

this is considered a ‘‘refusal to test.’’ 

The collector must stop the collection 

and report the refusal to test as 

described in Section 8.13. 

Section 8.4 What steps does the 

collector take in the collection 

procedure before the donor provides a 

urine specimen? 

(a) The collector will provide or the 

donor may select a specimen collection 

container that is clean, unused, 

wrapped/sealed in original packaging 

and compliant with subpart G of these 

Guidelines. The specimen collection 

container package will be opened in 

view of the donor. 

(b)The collector instructs the donor to 

provide the specimen in the privacy of 

a stall or otherwise partitioned area that 

allows for individual privacy. The 

collector directs the donor to provide a 

specimen of at least 45 mL, to not flush 

the toilet, and to return with the 

specimen as soon as the donor has 

completed the void. 

(1) Except in the case of a direct 

observed collection (i.e., as described in 

Section 8.10) or a monitored collection 

(i.e., as described in Section 8.12), 

neither the collector nor anyone else 

may go into the room with the donor. 

(2) The collector may set a reasonable 

time limit for specimen collection. 

(c) The collector notes any unusual 

behavior or appearance of the donor on 

the Federal CCF. If the collector detects 

any conduct that clearly indicates an 

attempt to tamper with a specimen (e.g., 

substitute urine in plain view or an 

attempt to bring into the collection site 

an adulterant or urine substitute), the 

collector must report a refusal to test in 

accordance with Section 8.13. 

Section 8.5 What steps does the 

collector take during and after the urine 

specimen collection procedure? 

Integrity and Identity of the 

Specimen. The collector must take the 

following steps during and after the 

donor provides the urine specimen: 

(a) The collector must inform the 

donor that, once the collection 

procedure has begun, the donor must 

remain at the collection site (i.e., in an 

area designated by the collector) until 

the collection is complete and that 

failure to follow these instructions will 

be reported as a refusal to test. This 

includes the wait period (i.e., up to 3 

hours) if needed to provide a sufficient 

specimen as described in Sections 

8.5(f)(2) and 8.6. 

(b) After providing the specimen, the 

donor gives the specimen collection 

container to the collector. Both the 

donor and the collector must keep the 

specimen container in view at all times 

until the collector seals the specimen 

bottles as described in Section 8.8. 


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70786 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

(c) After the donor has given the 

specimen to the collector, whenever 

practical, the donor shall be allowed to 

wash the donor’s hands and the donor 

may flush the toilet. 

(d) The collector must measure the 

temperature of the specimen within 4 

minutes of receiving the specimen from 

the donor. The collector records on the 

Federal CCF whether or not the 

temperature is in the acceptable range of 

32°–38°C/90°–100 °F. 

(1) The temperature measuring device 

must accurately reflect the temperature 

of the specimen and not contaminate 

the specimen. 

(2) If the temperature of the specimen 

is outside the range of 32°–38°C/90°– 

100 °F, that is a reason to believe that 

the donor may have adulterated or 

substituted the specimen. Another 

specimen must be collected under direct 

observation in accordance with Section 

8.9. The collector must forward both 

specimens (i.e., from the first and 

second collections) to an HHS-certified 

laboratory for testing and record a 

comment on the Federal CCF for each 

specimen. 

(e) The collector must inspect the 

specimen to determine if there is any 

sign indicating that the specimen may 

not be a valid urine specimen (e.g., 

unusual color, presence of foreign 

objects or material, unusual odor). 

(1) The collector notes any unusual 

finding on the Federal CCF. A specimen 

suspected of not being a valid urine 

specimen must be forwarded to an HHScertified laboratory for testing. 

(2) When there is any reason to 

believe that a donor may have 

adulterated or substituted the specimen, 

another specimen must be obtained as 

soon as possible under direct 

observation in accordance with Section 

8.10. The collector must forward both 

specimens (i.e., from the first and 

second collections) to an HHS-certified 

laboratory for testing and record a 

comment on the Federal CCF for each 

specimen. 

(f) The collector must determine the 

volume of urine in the specimen 

container. The collector must never 

combine urine collected from separate 

voids to create a specimen. 

(1) If the volume is at least 45 mL, the 

collector will proceed with steps 

described in Section 8.8. 

(2) If the volume is less than 45 mL, 

the collector discards the specimen and 

immediately collects a second specimen 

using the same procedures as for the 

first specimen (including steps in 

Section 8.5(c) and (d)). 

(i) The collector may give the donor 

a reasonable amount of liquid to drink 

for this purpose (e.g., an 8 ounce glass 

of water every 30 minutes, but not to 

exceed a maximum of 40 ounces over a 

period of 3 hours or until the donor has 

provided a sufficient urine specimen). 

However, the donor is not required to 

drink any fluids during this waiting 

time. 

(ii) If the donor provides a sufficient 

urine specimen (i.e., at least 45 mL), the 

collector proceeds with steps described 

in Section 8.8. 

(iii) If the employee has not provided 

a sufficient specimen (i.e., at least 45 

mL) within three hours of the first 

unsuccessful attempt to provide the 

specimen, the collector records the 

reason for not collecting a urine 

specimen on the Federal CCF, notifies 

the Federal agency’s designated 

representative for authorization to 

collect an alternate specimen, and sends 

the appropriate copies of the Federal 

CCF to the MRO and to the Federal 

agency’s designated representative. The 

Federal agency may choose to provide 

the collection site with a standard 

protocol to follow in lieu of requiring 

the collector to notify the agency’s 

designated representative for 

authorization in each case. If an 

alternate specimen is authorized, the 

collector may begin the collection 

procedure for the alternate specimen 

(see Section 8.7) in accordance with the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

the alternate specimen. 

(g) If the donor fails to remain present 

through the completion of the 

collection, declines to have a direct 

observed collection as required in 

Section 8.5(d)(2) or (e)(2), refuses to 

provide a second specimen as required 

in Section 8.5(f)(2), or refuses to provide 

an alternate specimen as authorized in 

Section 8.5(f)(2)(iii), the collector stops 

the collection and reports the refusal to 

test in accordance with Section 8.13. 

Section 8.6 What procedure is used 

when the donor states that they are 

unable to provide a urine specimen? 

(a) If the donor states that they are 

unable to provide a urine specimen 

during the collection process, the 

collector requests that the donor enter 

the restroom (stall) and attempt to 

provide a urine specimen. 

(b) The donor demonstrates their 

inability to provide a specimen when he 

or she comes out of the stall with an 

empty collection container. 

(1) If the donor states that they could 

provide a specimen after drinking some 

fluids, the collector gives the donor a 

reasonable amount of liquid to drink for 

this purpose (e.g., an 8 ounce glass of 

water every 30 minutes, but not to 

exceed a maximum of 40 ounces over a 

period of 3 hours or until the donor has 

provided a sufficient urine specimen). If 

the donor simply needs more time 

before attempting to provide a urine 

specimen, the donor may choose not to 

drink any fluids during the 3 hour wait 

time. 

(2) If the donor states that they are 

unable to provide a urine specimen, the 

collector records the reason for not 

collecting a urine specimen on the 

Federal CCF, notifies the Federal 

agency’s designated representative for 

authorization to collect an alternate 

specimen, and sends the appropriate 

copies of the Federal CCF to the MRO 

and to the Federal agency’s designated 

representative. The Federal agency may 

choose to provide the collection site 

with a standard protocol to follow in 

lieu of requiring the collector to notify 

the agency’s designated representative 

for authorization in each case. If an 

alternate specimen is authorized, the 

collector may begin the collection 

procedure for the alternate specimen 

(see Section 8.7) in accordance with the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

the alternate specimen. 

Section 8.7 If the donor is unable to 

provide a urine specimen, may another 

specimen type be collected for testing? 

Yes, if the alternate specimen type is 

authorized by Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs and specifically authorized by 

the Federal agency. 

Section 8.8 How does the collector 

prepare the urine specimens? 

(a) All Federal agency collections are 

to be split specimen collections. 

(b) The collector, in the presence of 

the donor, pours the urine from the 

collection container into two specimen 

bottles to be labeled ‘‘A’’ and ‘‘B’’. The 

collector pours at least 30 mL of urine 

into Bottle A and at least 15 mL into 

Bottle B, and caps each bottle. 

(c) In the presence of the donor, the 

collector places a tamper-evident label/ 

seal from the Federal CCF over each 

specimen bottle cap. The collector 

records the date of the collection on the 

tamper-evident labels/seals. 

(d) The collector instructs the donor 

to initial the tamper-evident labels/seals 

on each specimen bottle. If the donor 

refuses to initial the labels/seals, the 

collector notes the refusal on the 

Federal CCF and continues with the 

collection process. 

(e) The collector must ensure that all 

required information is included on the 

Federal CCF. 

(f) The collector asks the donor to 

read and sign a statement on the Federal 


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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 70787 

CCF certifying that the specimens 

identified were collected from the 

donor. If the donor refuses to sign the 

certification statement, the collector 

notes the refusal on the Federal CCF and 

continues with the collection process. 

(g) The collector signs and prints their 

name on the Federal CCF, completes the 

Federal CCF, and distributes the copies 

of the Federal CCF as required. 

(h) The collector seals the specimens 

(Bottle A and Bottle B) in a package and, 

within 24 hours or during the next 

business day, sends them to the HHScertified laboratory or IITF that will be 

testing the Bottle A urine specimen. 

(i) If the specimen and Federal CCF 

are not immediately transported to an 

HHS-certified laboratory or IITF, they 

must remain under direct control of the 

collector or be appropriately secured 

under proper specimen storage 

conditions until transported. 

(j) The collector must discard any 

urine left over in the collection 

container after both specimen bottles 

have been appropriately filled and 

sealed. There is one exception to this 

requirement: the collector may use 

excess urine to conduct clinical tests 

(e.g., protein, glucose) if the collection 

was conducted in conjunction with a 

physical examination required by 

Federal agency regulation. Neither the 

collector nor anyone else may conduct 

further testing (such as specimen 

validity testing) on the excess urine. 

Section 8.9 When is a direct observed 

collection conducted? 

A direct observed collection 

procedure must be conducted when: 

(a) The agency has authorized a direct 

observed collection because: 

(1) The donor’s previous drug test 

result was reported by an MRO as 

positive, adulterated, or substituted; or 

(2) The HHS-certified laboratory 

reports to the MRO that a specimen is 

invalid, and the MRO reported to the 

agency that there was not a legitimate 

medical explanation for the result; or 

(3) The MRO reported to the agency 

that the primary (A) specimen was 

positive, adulterated, or substituted but 

the test was cancelled because the split 

(B) specimen could not be tested or the 

split specimen failed to reconfirm the 

primary specimen result; or 

(b) At the collection site, an 

immediate collection of a second urine 

specimen is required because: 

(1) The temperature of the specimen 

collected during a routine collection is 

outside the acceptable temperature 

range; or 

(2) The collector suspects that the 

donor has tampered with the specimen 

during a routine collection (e.g., 

abnormal physical characteristic such as 

unusual color and/or odor, and/or 

excessive foaming when shaken). 

(c) The collector must contact a 

collection site supervisor to review and 

concur in advance with any decision by 

the collector to obtain a specimen under 

direct observation. 

(d) If the donor declines to have a 

direct observed collection, the collector 

reports a refusal to test (i.e., as described 

in Section 8.13). 

Section 8.10 How is a direct observed 

collection conducted? 

(a) A direct observed collection 

procedure is the same as that for a 

routine collection, except an observer 

watches the donor urinate into the 

collection container. The observer’s 

gender must be the same as the donor’s 

gender, which is determined by the 

donor’s gender identity, with no 

exception to this requirement. 

(b) Before an observer is selected, the 

collector informs the donor that the 

gender of the observer will match the 

donor’s gender, which is determined by 

the donor’s gender identity (as defined 

in Section 1.5). The collector then 

selects the observer to conduct the 

observation: 

(i) The collector asks the donor to 

identify the donor’s gender on the 

Federal CCF and initial it. 

(ii) The donor will then be provided 

an observer whose gender matches the 

donor’s gender. 

(iii) The collector documents the 

observer’s name and gender on the 

Federal CCF. 

(c) If there is no collector available of 

the same gender as the donor’s gender, 

the collector or collection site 

supervisor shall select an observer 

trained in direct observed specimen 

collection as described in Section 4.4. 

The observer may be an individual that 

is not a trained collector. 

(d) At the point in a routine collection 

where the donor enters the restroom 

with the collection container, a direct 

observed collection includes the 

following additional steps: 

(1) The observer enters the restroom 

with the donor; 

(2) The observer must directly watch 

the urine go from the donor’s body into 

the collection container (the use of 

mirrors or video cameras is not 

permitted); 

(3) The observer must not touch or 

handle the collection container unless 

the observer is also serving as the 

collector; 

(4) After the donor has completed 

urinating into the collection container: 

(i) If the same person serves as the 

observer and collector, that person may 

receive the collection container from the 

donor while they are both in the 

restroom; 

(ii) If the observer is not serving as the 

collector, the donor and observer leave 

the restroom and the donor hands the 

collection container directly to the 

collector. The observer must maintain 

visual contact of the collection 

container until the donor hands the 

container to the collector. 

(5) The collector checks the box for an 

observed collection on the Federal CCF 

and writes the name of the observer and 

the reason for an observed collection on 

the Federal CCF; and 

(6) The collector then continues with 

the routine collection procedure in 

Section 8.3. 

Section 8.11 When is a monitored 

collection conducted? 

(a) In the event that an agencydesignated collection site is not 

available and there is an immediate 

requirement to collect a specimen (e.g., 

an accident investigation), a public 

restroom may be used for the collection, 

using the procedures for a monitored 

collection described in Section 8.12. 

(b) If the enclosure used by the donor 

to provide a specimen has a source of 

water that cannot be disabled or 

secured, a monitored collection must be 

conducted. 

(c) If the donor declines to permit a 

collection to be monitored when 

required, the collector reports a refusal 

to test (i.e., as described in Section 

8.13). 

Section 8.12 How is a monitored 

collection conducted? 

A monitored collection is the same as 

that for a routine collection, except that 

a monitor accompanies the donor into 

the restroom to check for signs that the 

donor may be tampering with the 

specimen. The monitor remains in the 

restroom, but outside the stall, while the 

donor is providing the specimen. A 

person of the same gender as the donor 

shall serve as the monitor, unless the 

monitor is a medical professional (e.g., 

nurse, doctor, physician’s assistant, 

technologist, or technician licensed or 

certified to practice in the jurisdiction 

in which the collection takes place). The 

same procedures used for selecting an 

observer of the appropriate gender in 

Section 8.10(b) must be used to select 

the monitor for the purposes of Section 

8.12, unless the monitor is a medical 

professional as described above. The 

monitor may be an individual other 

than the collector and need not be a 

qualified collector. 

(a) The collector secures the restroom 

being used for the monitored collection 

so that no one except the employee and 


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70788 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 

the monitor can enter the restroom until 

after the collection has been completed. 

(b) The monitor enters the restroom 

with the donor. 

(c) The monitor must not watch the 

employee urinate into the collection 

container. If the monitor hears sounds 

or makes other observations indicating 

an attempt by the donor to tamper with 

a specimen, there must be an additional 

collection under direct observation in 

accordance with Section 8.9. 

(d) The monitor must not touch or 

handle the collection container unless 

the monitor is also the collector. 

(e) After the donor has completed 

urinating into the collection container: 

(1) If the same person serves as the 

monitor and collector, that person may 

receive the collection container from the 

donor while they are both in the 

restroom; 

(2) If the monitor is not serving as the 

collector, the donor and monitor leave 

the restroom and the donor hands the 

collection container directly to the 

collector. The monitor must ensure that 

the employee takes the collection 

container directly to the collector as 

soon as the employee has exited the 

enclosure. 

(f) If the monitor is not serving as the 

collector, the collector writes the name 

of the monitor on the Federal CCF. 

(g) The collector then continues with 

the routine collection procedure in 

Section 8.3. 

Section 8.13 How does the collector 

report a donor’s refusal to test? 

If there is a refusal to test as defined 

in Section 1.7, the collector stops the 

collection, discards any urine collected 

and reports the refusal to test by: 

(a) Notifying the Federal agency by 

means (e.g., telephone, email, or secure 

fax) that ensures that the notification is 

immediately received, 

(b) Documenting the refusal to test 

including the reason on the Federal 

CCF, and 

(c) Sending all copies of the Federal 

CCF to the Federal agency’s designated 

representative. 

Section 8.14 What are a Federal 

agency’s responsibilities for a collection 

site? 

(a) A Federal agency must ensure that 

collectors and collection sites satisfy all 

requirements in subparts D, E, F, G, and 

H of these Guidelines. 

(b) A Federal agency (or only one 

Federal agency when several agencies 

are using the same collection site) must 

inspect 5 percent or up to a maximum 

of 50 collection sites each year, selected 

randomly from those sites used to 

collect agency specimens (e.g., virtual, 

onsite, or self-evaluation). 

(c) A Federal agency must investigate 

reported collection site deficiencies 

(e.g., specimens reported ‘‘rejected for 

testing’’ by an HHS-certified laboratory 

or IITF) and take appropriate action 

which may include a collection site selfassessment (i.e., using the Collection 

Site Checklist for the Collection of Urine 

Specimens for Federal agency 

Workplace Drug Testing Programs) or an 

inspection of the collection site. The 

inspections of these additional 

collection sites may be included in the 

5 percent or maximum of 50 collection 

sites inspected annually. 

Subpart I—HHS Certification of 

Laboratories and IITFs 

Section 9.1 Who has the authority to 

certify laboratories and IITFs to test 

urine specimens for Federal agencies? 

(a) The Secretary has broad discretion 

to take appropriate action to ensure the 

full reliability and accuracy of drug 

testing and reporting, to resolve 

problems related to drug testing, and to 

enforce all standards set forth in these 

Guidelines. The Secretary has the 

authority to issue directives to any HHScertified laboratory or IITF including 

suspending the use of certain analytical 

procedures when necessary to protect 

the integrity of the testing process; 

ordering any HHS-certified laboratory or 

IITF to undertake corrective actions to 

respond to material deficiencies 

identified by an inspection or through 

performance testing; ordering any HHScertified laboratory or IITF to send 

specimens or specimen aliquots to 

another HHS-certified laboratory for 

retesting when necessary to ensure the 

accuracy of testing under these 

Guidelines; ordering the review of 

results for specimens tested under the 

Guidelines for private sector clients to 

the extent necessary to ensure the full 

reliability of drug testing for Federal 

agencies; and ordering any other action 

necessary to address deficiencies in 

drug testing, analysis, specimen 

collection, chain of custody, reporting of 

results, or any other aspect of the 

certification program. 

(b) A laboratory or IITF is prohibited 

from stating or implying that it is 

certified by HHS under these Guidelines 

to test urine specimens for Federal 

agencies unless it holds such 

certification. 

Section 9.2 What is the process for a 

laboratory or IITF to become HHScertified? 

(a) A laboratory or IITF seeking HHS 

certification must: 

(1) Submit a completed OMBapproved application form (i.e., the 

applicant laboratory or IITF provides 

detailed information on both the 

administrative and analytical 

procedures to be used for federally 

regulated specimens); 

(2) Have its application reviewed as 

complete and accepted by HHS; 

(3) Successfully complete the PT 

challenges in 3 consecutive sets of 

initial PT samples; 

(4) Satisfy all the requirements for an 

initial inspection; and 

(5) Receive notification of certification 

from the Secretary before testing 

specimens for Federal agencies. 

Section 9.3 What is the process for a 

laboratory or IITF to maintain HHS 

certification? 

(a) To maintain HHS certification, a 

laboratory or IITF must: 

(1) Successfully participate in both 

the maintenance PT and inspection 

programs (i.e., successfully test the 

required quarterly sets of maintenance 

PT samples, undergo an inspection 3 

months after being certified, and 

undergo maintenance inspections at a 

minimum of every 6 months thereafter); 

(2) Respond in an appropriate, timely, 

and complete manner to required 

corrective action requests if deficiencies 

are identified in the maintenance PT 

performance, during the inspections, 

operations, or reporting; and 

(3) Satisfactorily complete corrective 

remedial actions, and undergo special 

inspection and special PT sets to 

maintain or restore certification when 

material deficiencies occur in either the 

PT program, inspection program, or in 

operations and reporting. 

Section 9.4 What is the process when 

a laboratory or IITF does not maintain 

its HHS certification? 

(a) A laboratory or IITF that does not 

maintain its HHS certification must: 

(1) Stop testing federally regulated 

specimens; 

(2) Ensure the security of federally 

regulated specimens and records 

throughout the required storage period 

described in Sections 11.20, 11.21, 

12.18, and 14.8; 

(3) Ensure access to federally 

regulated specimens and records in 

accordance with Sections 11.23, 11.24, 

12.20, and 12.21 and subpart P of these 

Guidelines; and 

(4) Follow the HHS suspension and 

revocation procedures when imposed by 

the Secretary, follow the HHS 

procedures in subpart P of these 

Guidelines that will be used for all 

actions associated with the suspension 

and/or revocation of HHS-certification. 


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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 70789 

Section 9.5 What are the qualitative 

and quantitative specifications of 

performance testing (PT) samples? 

(a) PT samples used to evaluate drug 

tests will be prepared using the 

following specifications: 

(1) PT samples may contain one or 

more of the drugs and drug metabolites 

in the drug classes listed in the drug 

testing panel and must satisfy one of the 

following parameters: 

(i) The concentration of a drug or 

metabolite will be at least 20 percent 

above the initial test cutoff for the drug 

or drug metabolite; 

(ii) The concentration of a drug or 

metabolite may be as low as 40 percent 

of the confirmatory test cutoff when the 

PT sample is designated as a retest 

sample; or 

(iii) The concentration of drug or 

metabolite may differ from Section 

9.5(a)(1)(i) and (ii) for a special purpose. 

(2) A PT sample may contain an 

interfering substance, an adulterant, or 

other substances for special purposes, or 

may satisfy the criteria for a substituted 

specimen, dilute specimen, or invalid 

result. 

(3) A negative PT sample will not 

contain a measurable amount of a target 

analyte. 

(b) PT samples used to evaluate 

specimen validity tests shall satisfy, but 

are not limited to, one of the following 

criteria: 

(1) The nitrite concentration will be at 

least 20 percent above the cutoff; 

(2) The pH will be between 1.5 and 

5.0 or between 8.5 and 12.5; 

(3) The concentration of an oxidant 

will be at a level sufficient to challenge 

a laboratory’s ability to identify and 

confirm the oxidant; 

(4) The creatinine concentration will 

be between 0 and 20 mg/dL; or 

(5) The specific gravity will be less 

than or equal to 1.0050 or between 

1.0170 and 1.0230. 

(c) For each PT cycle, the set of PT 

samples going to each HHS-certified 

laboratory or IITF will vary but, within 

each calendar year, each HHS-certified 

laboratory or IITF will analyze 

essentially the same total set of samples. 

(d) The laboratory or IITF must (to the 

greatest extent possible) handle, test, 

and report a PT sample in a manner 

identical to that used for a donor 

specimen, unless otherwise specified. 

Section 9.6 What are the PT 

requirements for an applicant 

laboratory that seeks to perform urine 

testing? 

(a) An applicant laboratory that seeks 

certification under these Guidelines to 

perform urine testing must satisfy the 

following criteria on three consecutive 

sets of PT samples: 

(1) Have no false positive results; 

(2) Correctly identify, confirm, and 

report at least 90 percent of the total 

drug challenges over the three sets of PT 

samples; 

(3) Correctly identify at least 80 

percent of the drug challenges for each 

initial drug test over the three sets of PT 

samples; 

(4) For the confirmatory drug tests, 

correctly determine the concentrations 

(i.e., no more than ±20 percent or ±2 

standard deviations [whichever is 

larger] from the appropriate reference or 

peer group means) for at least 80 percent 

of the total drug challenges over the 

three sets of PT samples; 

(5) For the confirmatory drug tests, do 

not obtain any drug concentration that 

differs by more than ±50 percent from 

the appropriate reference or peer group 

mean; 

(6) For each confirmatory drug test, 

correctly identify and determine the 

concentrations (i.e., no more than ±20 

percent or ±2 standard deviations 

[whichever is larger] from the 

appropriate reference or peer group 

means) for at least 50 percent of the 

drug challenges for an individual drug 

over the three sets of PT samples; 

(7) Correctly identify at least 80 

percent of the total specimen validity 

testing challenges over the three sets of 

PT samples; 

(8) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

the three sets of PT samples; 

(9) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total challenges 

over the three sets of PT samples that 

satisfy the following criteria: 

(i) Nitrite and creatinine 

concentrations are no more than ±20 

percent or ±2 standard deviations from 

the appropriate reference or peer group 

mean; and 

(ii) pH values are no more than ±0.3 

pH units from the appropriate reference 

or peer group mean using a pH meter; 

and 

(iii) Specific gravity values are no 

more than ±0.0003 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is less than 

1.0100 and specific gravity values are no 

more than ±0.0004 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is equal to 

or greater than 1.0100; 

(10) Do not obtain any quantitative 

value on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for nitrite and 

creatinine concentrations, ±0.8 pH units 

using a pH meter, ±0.0006 specific 

gravity units when the mean is less than 

1.0100, or ±0.0007 specific gravity units 

when the mean is equal to or greater 

than 1.0100; and 

(11) Do not report any sample as 

adulterated with a compound that is not 

present in the sample, adulterated based 

on pH when the appropriate reference 

or peer group mean is within the 

acceptable pH range, substituted when 

the appropriate reference or peer group 

means for both creatinine and specific 

gravity are within the acceptable range, 

or substituted when the appropriate 

reference or peer group mean for a 

biomarker is within the acceptable 

range. 

(b) Failure to satisfy these 

requirements will result in the denial of 

the laboratory’s application for HHS 

certification to perform urine testing. 

Section 9.7 What are the PT 

requirements for an HHS-certified urine 

laboratory? 

(a) A laboratory certified under these 

Guidelines to perform urine testing 

must satisfy the following criteria on the 

maintenance PT samples: 

(1) Have no false positive results; 

(2) Correctly identify, confirm, and 

report at least 90 percent of the total 

drug challenges over two consecutive 

PT cycles; 

(3) Correctly identify at least 80 

percent of the drug challenges for each 

initial drug test over two consecutive PT 

cycles; 

(4) For the confirmatory drug tests, 

correctly determine that the 

concentrations for at least 80 percent of 

the total drug challenges are no more 

than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

means over two consecutive PT cycles; 

(5) For the confirmatory drug tests, do 

not obtain any drug concentration that 

differs by more than ±50 percent from 

the appropriate reference or peer group 

means; 

(6) For each confirmatory drug test, 

correctly identify and determine that the 

concentrations for at least 50 percent of 

the drug challenges for an individual 

drug are no more than ±20 percent or ±2 

standard deviations (whichever is 

larger) from the appropriate reference or 

peer group means over two consecutive 

PT cycles; 

(7) Correctly identify at least 80 

percent of the total specimen validity 

testing challenges over two consecutive 

PT cycles; 

(8) Correctly identify at least 80 

percent of the challenges for each 


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individual specimen validity test over 

two consecutive PT cycles; 

(9) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total challenges 

over two consecutive PT cycles that 

satisfy the following criteria: 

(i) Nitrite and creatinine 

concentrations are no more than ±20 

percent or ±2 standard deviations from 

the appropriate reference or peer group 

mean; 

(ii) pH values are no more than ±0.3 

pH units from the appropriate reference 

or peer group mean using a pH meter; 

and 

(iii) Specific gravity values are no 

more than ±0.0003 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is less than 

1.0100 and specific gravity values are no 

more than ±0.0004 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is equal to 

or greater than 1.0100; 

(10) Do not obtain any quantitative 

value on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for nitrite and 

creatinine concentrations, ±0.8 pH units 

using a pH meter, ±0.0006 specific 

gravity units when the mean is less than 

1.0100, or ±0.0007 specific gravity units 

when the mean is equal to or greater 

than 1.0100; and 

(11) Do not report any PT sample as 

adulterated with a compound that is not 

present in the sample, adulterated based 

on pH when the appropriate reference 

or peer group mean is within the 

acceptable pH range, substituted when 

the appropriate reference or peer group 

means for both creatinine and specific 

gravity are within the acceptable range, 

or substituted when the appropriate 

reference or peer group mean for a 

biomarker is within the acceptable 

range. 

(b) Failure to participate in all PT 

cycles or to satisfy these requirements 

may result in suspension or revocation 

of an HHS-certified laboratory’s 

certification. 

Section 9.8 What are the PT 

requirements for an applicant IITF? 

(a) An applicant IITF that seeks 

certification under these Guidelines 

must satisfy the following criteria on 

three consecutive sets of PT samples: 

(1) Correctly identify at least 90 

percent of the total drug challenges over 

the three sets of PT samples; 

(2) Correctly identify at least 80 

percent of the drug challenges for each 

individual drug test over the three sets 

of PT samples; 

(3) Correctly identify at least 80 

percent of the total specimen validity 

test challenges over the three sets of PT 

samples; 

(4) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

the three sets of PT samples; 

(5) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total specimen 

validity test challenges over the three 

sets of PT samples that satisfy the 

following criteria: 

(i) Creatinine concentrations are no 

more than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

mean; and 

(ii) Specific gravity values are no 

more than ±0.001 specific gravity units 

from the appropriate reference or peer 

group mean; and 

(6) Must not obtain any quantitative 

value on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for creatinine 

concentration or ±0.002 specific gravity 

units for specific gravity. 

(b) Failure to satisfy these 

requirements will result in 

disqualification. 

Section 9.9 What are the PT 

requirements for an HHS-certified IITF? 

(a) An IITF certified under these 

Guidelines must satisfy the following 

criteria on the maintenance PT samples 

to maintain its certification: 

(1) Correctly identify at least 90 

percent of the total drug challenges over 

two consecutive PT cycles; 

(2) Correctly identify at least 80 

percent of the drug challenges for each 

individual drug test over two 

consecutive PT cycles; 

(3) Correctly identify at least 80 

percent of the total specimen validity 

test challenges over two consecutive PT 

cycles; 

(4) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

two consecutive PT cycles; 

(5) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total specimen 

validity test challenges over two 

consecutive PT cycles that satisfy the 

following criteria: 

(i) Creatinine concentrations are no 

more than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

mean; and 

(ii) Specific gravity values are no 

more than ±0.001 specific gravity units 

from the appropriate reference or peer 

group mean; and 

(6) Must not obtain any quantitative 

value on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for creatinine 

concentration, or ±0.002 specific gravity 

units for specific gravity. 

(b) Failure to participate in all PT 

cycles or to satisfy these requirements 

may result in suspension or revocation 

of an HHS-certified IITF’s certification. 

Section 9.10 What are the inspection 

requirements for an applicant 

laboratory or IITF? 

(a) An applicant laboratory or IITF is 

inspected by a team of two inspectors. 

(b) Each inspector conducts an 

independent review and evaluation of 

all aspects of the laboratory’s or IITF’s 

testing procedures and facilities using 

an inspection checklist. 

Section 9.11 What are the 

maintenance inspection requirements 

for an HHS-certified laboratory or IITF? 

(a) An HHS-certified laboratory or 

IITF must undergo an inspection 3 

months after becoming certified and at 

least every 6 months thereafter. 

(b) An HHS-certified laboratory or 

IITF is inspected by two or more 

inspectors. The number of inspectors is 

determined according to the number of 

specimens reviewed. Additional 

information regarding inspections is 

available from SAMHSA. 

(c) Each inspector conducts an 

independent evaluation and review of 

the HHS-certified laboratory’s or IITF’s 

procedures, records, and facilities using 

guidance provided by the Secretary. 

(d) To remain certified, an HHScertified laboratory or IITF must 

continue to satisfy the minimum 

requirements as stated in these 

Guidelines. 

Section 9.12 Who can inspect an HHScertified laboratory or IITF and when 

may the inspection be conducted? 

(a) An individual may be selected as 

an inspector for the Secretary if they 

satisfy the following criteria: 

(1) Has experience and an educational 

background similar to that required for 

either a responsible person or a 

certifying scientist for an HHS-certified 

laboratory as described in subpart K of 

these Guidelines or as a responsible 

technician for an HHS-certified IITF as 

described in subpart L of these 

Guidelines; 

(2) Has read and thoroughly 

understands the policies and 

requirements contained in these 

Guidelines and in other guidance 


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consistent with these Guidelines 

provided by the Secretary; 

(3) Submits a resume and 

documentation of qualifications to HHS; 

(4) Attends approved training; and 

(5) Performs acceptably as an 

inspector on an inspection of an HHScertified laboratory or IITF. 

(b) The Secretary or a Federal agency 

may conduct an inspection at any time. 

Section 9.13 What happens if an 

applicant laboratory or IITF does not 

satisfy the minimum requirements for 

either the PT program or the inspection 

program? 

If an applicant laboratory or IITF fails 

to satisfy the requirements established 

for the initial certification process, the 

laboratory or IITF must start the 

certification process from the beginning. 

Section 9.14 What happens if an HHScertified laboratory or IITF does not 

satisfy the minimum requirements for 

either the PT program or the inspection 

program? 

(a) If an HHS-certified laboratory or 

IITF fails to satisfy the minimum 

requirements for certification, the 

laboratory or IITF is given a period of 

time (e.g., 5 or 30 working days 

depending on the nature of the 

deficiency) to provide any explanation 

for its performance and evidence that all 

deficiencies have been corrected. 

(b) A laboratory’s or IITF’s HHS 

certification may be revoked, 

suspended, or no further action taken 

depending on the seriousness of the 

deficiencies and whether there is 

evidence that the deficiencies have been 

corrected and that current performance 

meets the requirements for certification. 

(c) An HHS-certified laboratory or 

IITF may be required to undergo a 

special inspection or to test additional 

PT samples to address deficiencies. 

(d) If an HHS-certified laboratory’s or 

IITF’s certification is revoked or 

suspended in accordance with the 

process described in subpart P of these 

Guidelines, the laboratory or IITF is not 

permitted to test federally regulated 

specimens until the suspension is lifted 

or the laboratory or IITF has 

successfully completed the certification 

requirements as a new applicant 

laboratory or IITF. 

Section 9.15 What factors are 

considered in determining whether 

revocation of a laboratory’s or IITF’s 

HHS certification is necessary? 

(a) The Secretary shall revoke 

certification of an HHS-certified 

laboratory or IITF in accordance with 

these Guidelines if the Secretary 

determines that revocation is necessary 

to ensure fully reliable and accurate 

drug and specimen validity test results 

and reports. 

(b) The Secretary shall consider the 

following factors in determining 

whether revocation is necessary: 

(1) Unsatisfactory performance in 

analyzing and reporting the results of 

drug and specimen validity tests (e.g., 

an HHS-certified laboratory reporting a 

false positive result for an employee’s 

drug test); 

(2) Unsatisfactory participation in 

performance testing or inspections; 

(3) A material violation of a 

certification standard, contract term, or 

other condition imposed on the HHScertified laboratory or IITF by a Federal 

agency using the laboratory’s or IITF’s 

services; 

(4) Conviction for any criminal 

offense committed as an incident to 

operation of the HHS-certified 

laboratory or IITF; or 

(5) Any other cause that materially 

affects the ability of the HHS-certified 

laboratory or IITF to ensure fully 

reliable and accurate drug test results 

and reports. 

(c) The period and terms of revocation 

shall be determined by the Secretary 

and shall depend upon the facts and 

circumstances of the revocation and the 

need to ensure accurate and reliable 

drug testing. 

Section 9.16 What factors are 

considered in determining whether to 

suspend a laboratory’s or IITF’s HHS 

certification? 

(a) The Secretary may immediately 

suspend (either partially or fully) a 

laboratory’s or IITF’s HHS certification 

to conduct drug testing for Federal 

agencies if the Secretary has reason to 

believe that revocation may be required 

and that immediate action is necessary 

to protect the interests of the United 

States and its employees. 

(b) The Secretary shall determine the 

period and terms of suspension based 

upon the facts and circumstances of the 

suspension and the need to ensure 

accurate and reliable drug testing. 

Section 9.17 How does the Secretary 

notify an HHS-certified laboratory or 

IITF that action is being taken against 

the laboratory or IITF? 

(a) When laboratory’s or IITF’s HHS 

certification is suspended or the 

Secretary seeks to revoke HHS 

certification, the Secretary shall 

immediately serve the HHS-certified 

laboratory or IITF with written notice of 

the suspension or proposed revocation 

by fax, mail, personal service, or 

registered or certified mail, return 

receipt requested. This notice shall state 

the following: 

(1) The reasons for the suspension or 

proposed revocation; 

(2) The terms of the suspension or 

proposed revocation; and 

(3) The period of suspension or 

proposed revocation. 

(b) The written notice shall state that 

the laboratory or IITF will be afforded 

an opportunity for an informal review of 

the suspension or proposed revocation 

if it so requests in writing within 30 

days of the date the laboratory or IITF 

received the notice, or if expedited 

review is requested, within 3 days of the 

date the laboratory or IITF received the 

notice. Subpart P of these Guidelines 

contains detailed procedures to be 

followed for an informal review of the 

suspension or proposed revocation. 

(c) A suspension must be effective 

immediately. A proposed revocation 

must be effective 30 days after written 

notice is given or, if review is requested, 

upon the reviewing official’s decision to 

uphold the proposed revocation. If the 

reviewing official decides not to uphold 

the suspension or proposed revocation, 

the suspension must terminate 

immediately and any proposed 

revocation shall not take effect. 

(d) The Secretary will publish in the 

Federal Register the name, address, and 

telephone number of any HHS-certified 

laboratory or IITF that has its 

certification revoked or suspended 

under Section 9.13 or 9.14, respectively, 

and the name of any HHS-certified 

laboratory or IITF that has its 

suspension lifted. The Secretary shall 

provide to any member of the public 

upon request the written notice 

provided to a laboratory or IITF that has 

its HHS certification suspended or 

revoked, as well as the reviewing 

official’s written decision which 

upholds or denies the suspension or 

proposed revocation under the 

procedures of subpart P of these 

Guidelines. 

Section 9.18 May a laboratory or IITF 

that had its HHS certification revoked 

be recertified to test Federal agency 

specimens? 

Following revocation, a laboratory or 

IITF may apply for recertification. 

Unless otherwise provided by the 

Secretary in the notice of revocation 

under Section 9.17 or the reviewing 

official’s decision under Section 16.9(e) 

or 16.14(a), a laboratory or IITF which 

has had its certification revoked may 

reapply for HHS certification as an 

applicant laboratory or IITF. 


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Section 9.19 Where is the list of HHScertified laboratories and IITFs 

published? 

(a) The list of HHS-certified 

laboratories and IITFs is published 

monthly in the Federal Register. This 

notice is also available on the internet 

at https://www.samhsa.gov/workplace. 

(b) An applicant laboratory or IITF is 

not included on the list. 

Subpart J—Blind Samples Submitted 

by an Agency 

Section 10.1 What are the 

requirements for Federal agencies to 

submit blind samples to HHS-certified 

laboratories or IITFs? 

(a) Each Federal agency is required to 

submit blind samples for its workplace 

drug testing program. The collector 

must send the blind samples to the 

HHS-certified laboratory or IITF that the 

collector sends employee specimens. 

(b) Each Federal agency must submit 

at least 3 percent blind samples along 

with its donor specimens based on the 

projected total number of donor 

specimens collected per year (up to a 

maximum of 400 blind samples). Every 

effort should be made to ensure that 

blind samples are submitted quarterly. 

(c) Approximately 75 percent of the 

blind samples submitted each year by 

an agency must be negative, 15 percent 

must be positive for one or more drugs, 

and 10 percent must either be 

adulterated or substituted. 

Section 10.2 What are the 

requirements for blind samples? 

(a) Drug positive blind samples must 

be validated by the supplier as to their 

content using appropriate initial and 

confirmatory tests. 

(1) Drug positive blind samples must 

contain one or more of the drugs or 

metabolites listed in the drug testing 

panel. 

(2) Drug positive blind samples must 

contain concentrations of drugs between 

1.5 and 2 times the initial drug test 

cutoff. 

(b) Drug negative blind samples (i.e., 

certified to contain no drugs) must be 

validated by the supplier as negative 

using appropriate initial and 

confirmatory tests. 

(c) A blind sample that is adulterated 

must be validated using appropriate 

initial and confirmatory specimen 

validity tests, and have the 

characteristics to clearly show that it is 

an adulterated sample at the time of 

validation. 

(d) A blind sample that is substituted 

must be validated using appropriate 

initial and confirmatory specimen 

validity tests, and have the 

characteristics to clearly show that it is 

a substituted sample at the time of 

validation. 

(e) The supplier must provide 

information on the blind samples’ 

content, validation, expected results, 

and stability to the collection site/ 

collector sending the blind samples to 

the laboratory or IITF, and must provide 

the information upon request to the 

MRO, the Federal agency for which the 

blind sample was submitted, or the 

Secretary. 

Section 10.3 How is a blind sample 

submitted to an HHS-certified 

laboratory or IITF? 

(a) A blind sample must be submitted 

as a split specimen (specimens A and B) 

with the current Federal CCF that the 

HHS-certified laboratory or IITF uses for 

donor specimens. The collector 

provides the required information to 

ensure that the Federal CCF has been 

properly completed and provides 

fictitious initials on the specimen label/ 

seal. The collector must indicate that 

the specimen is a blind sample on the 

MRO copy where a donor would 

normally provide a signature. 

(b) A collector should attempt to 

distribute the required number of blind 

samples randomly with donor 

specimens rather than submitting the 

full complement of blind samples as a 

single group. 

Section 10.4 What happens if an 

inconsistent result is reported for a 

blind sample? 

If an HHS-certified laboratory or IITF 

reports a result for a blind sample that 

is inconsistent with the expected result 

(e.g., a laboratory or IITF reports a 

negative result for a blind sample that 

was supposed to be positive, a 

laboratory reports a positive result for a 

blind sample that was supposed to be 

negative): 

(a) The MRO must contact the 

laboratory or IITF and attempt to 

determine if the laboratory or IITF made 

an error during the testing or reporting 

of the sample; 

(b) The MRO must contact the blind 

sample supplier and attempt to 

determine if the supplier made an error 

during the preparation or transfer of the 

sample; 

(c) The MRO must contact the 

collector and determine if the collector 

made an error when preparing the blind 

sample for transfer to the HHS-certified 

laboratory or IITF; 

(d) If there is no obvious reason for 

the inconsistent result, the MRO must 

notify both the Federal agency for which 

the blind sample was submitted and the 

Secretary; and 

(e) The Secretary shall investigate the 

blind sample error. A report of the 

Secretary’s investigative findings and 

the corrective action taken in response 

to identified deficiencies must be sent to 

the Federal agency. The Secretary shall 

ensure notification of the finding as 

appropriate to other Federal agencies 

and coordinate any necessary actions to 

prevent the recurrence of the error. 

Subpart K—Laboratory 

Section 11.1 What must be included in 

the HHS-certified laboratory’s standard 

operating procedure manual? 

(a) An HHS-certified laboratory must 

have a standard operating procedure 

(SOP) manual that describes, in detail, 

all HHS-certified laboratory operations. 

When followed, the SOP manual 

ensures that all specimens are tested 

using the same procedures. 

(b) The SOP manual must include at 

a minimum, but is not limited to, a 

detailed description of the following: 

(1) Chain of custody procedures; 

(2) Accessioning; 

(3) Security; 

(4) Quality control/quality assurance 

programs; 

(5) Analytical methods and 

procedures; 

(6) Equipment and maintenance 

programs; 

(7) Personnel training; 

(8) Reporting procedures; and 

(9) Computers, software, and 

laboratory information management 

systems. 

(c) All procedures in the SOP manual 

must be compliant with these 

Guidelines and all guidance provided 

by the Secretary. 

(d) A copy of all procedures that have 

been replaced or revised and the dates 

on which the procedures were in effect 

must be maintained for at least 2 years. 

Section 11.2 What are the 

responsibilities of the responsible 

person (RP)? 

(a) Manage the day-to-day operations 

of the HHS-certified laboratory even if 

another individual has overall 

responsibility for alternate areas of a 

multi-specialty laboratory. 

(b) Ensure that there are sufficient 

personnel with adequate training and 

experience to supervise and conduct the 

work of the HHS-certified laboratory. 

The RP must ensure the continued 

competency of laboratory staff by 

documenting their in-service training, 

reviewing their work performance, and 

verifying their skills. 

(c) Maintain a complete and current 

SOP manual that is available to all 

personnel of the HHS-certified 


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laboratory and ensure that it is followed. 

The SOP manual must be reviewed, 

signed, and dated by the RP(s) when 

procedures are first placed into use and 

when changed or when a new 

individual assumes responsibility for 

the management of the HHS-certified 

laboratory. The SOP must be reviewed 

and documented by the RP annually. 

(d) Maintain a quality assurance 

program that ensures the proper 

performance and reporting of all test 

results; verify and monitor acceptable 

analytical performance for all controls 

and calibrators; monitor quality control 

testing; and document the validity, 

reliability, accuracy, precision, and 

performance characteristics of each test 

and test system. 

(e) Initiate and implement all 

remedial actions necessary to maintain 

satisfactory operation and performance 

of the HHS-certified laboratory in 

response to the following: quality 

control systems not within performance 

specifications; errors in result reporting 

or in analysis of performance testing 

samples; and inspection deficiencies. 

The RP must ensure that specimen 

results are not reported until all 

corrective actions have been taken and 

that the results provided are accurate 

and reliable. 

Section 11.3 What scientific 

qualifications must the RP have? 

The RP must have documented 

scientific qualifications in analytical 

toxicology. 

Minimum qualifications are: 

(a) Certification or licensure as a 

laboratory director by the state in 

forensic or clinical laboratory 

toxicology, a Ph.D. in one of the natural 

sciences, or training and experience 

comparable to a Ph.D. in one of the 

natural sciences with training and 

laboratory/research experience in 

biology, chemistry, and pharmacology 

or toxicology; 

(b) Experience in forensic toxicology 

with emphasis on the collection and 

analysis of biological specimens for 

drugs of abuse; 

(c) Experience in forensic applications 

of analytical toxicology (e.g., 

publications, court testimony, 

conducting research on the 

pharmacology and toxicology of drugs 

of abuse) or qualify as an expert witness 

in forensic toxicology; 

(d) Fulfillment of the RP 

responsibilities and qualifications, as 

demonstrated by the HHS-certified 

laboratory’s performance and verified 

upon interview by HHS-trained 

inspectors during each on-site 

inspection; and 

(e) Qualify as a certifying scientist. 

Section 11.4 What happens when the 

RP is absent or leaves an HHS-certified 

laboratory? 

(a) HHS-certified laboratories must 

have multiple RPs or one RP and an 

alternate RP. If the RP(s) are 

concurrently absent, an alternate RP 

must be present and qualified to fulfill 

the responsibilities of the RP. 

(1) If an HHS-certified laboratory is 

without the RP and alternate RP for 14 

calendar days or less (e.g., temporary 

absence due to vacation, illness, or 

business trip), the HHS-certified 

laboratory may continue operations and 

testing of Federal agency specimens 

under the direction of a certifying 

scientist. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend a 

laboratory’s HHS certification for all 

specimens if the laboratory does not 

have an RP or alternate RP for a period 

of more than 14 calendar days. The 

suspension will be lifted upon the 

Secretary’s approval of a new 

permanent RP or alternate RP. 

(b) If the RP leaves an HHS-certified 

laboratory: 

(1) The HHS-certified laboratory may 

maintain certification and continue 

testing federally regulated specimens 

under the direction of an alternate RP 

for a period of up to 180 days while 

seeking to hire and receive the 

Secretary’s approval of the RP’s 

replacement. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend a 

laboratory’s HHS certification for all 

federally regulated specimens if the 

laboratory does not have a permanent 

RP within 180 days. The suspension 

will be lifted upon the Secretary’s 

approval of the new permanent RP. 

(c) To nominate an individual as an 

RP or alternate RP, the HHS-certified 

laboratory must submit the following 

documents to the Secretary: the 

candidate’s current resume or 

curriculum vitae, copies of diplomas 

and licensures, a training plan (not to 

exceed 90 days) to transition the 

candidate into the position, an itemized 

comparison of the candidate’s 

qualifications to the minimum RP 

qualifications described in the 

Guidelines, and have official academic 

transcript(s) submitted from the 

candidate’s institution(s) of higher 

learning. The candidate must be found 

qualified during an on-site inspection of 

the HHS-certified laboratory. 

(d) The HHS-certified laboratory must 

fulfill additional inspection and PT 

criteria as required prior to conducting 

federally regulated testing under a new 

RP. 

Section 11.5 What qualifications must 

an individual have to certify a result 

reported by an HHS-certified 

laboratory? 

(a) A certifying scientist must have: 

(1) At least a bachelor’s degree in the 

chemical or biological sciences or 

medical technology, or equivalent; 

(2) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

laboratory relevant to the results that the 

individual certifies; and 

(3) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

(b) A certifying technician must have: 

(1) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

laboratory relevant to the results that the 

individual certifies; and 

(2) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

Section 11.6 What qualifications and 

training must other personnel of an 

HHS-certified laboratory have? 

(a) All HHS-certified laboratory staff 

(e.g., technicians, administrative staff) 

must have the appropriate training and 

skills for the tasks they perform. 

(b) Each individual working in an 

HHS-certified laboratory must be 

properly trained (i.e., receive training in 

each area of work that the individual 

will be performing, including training in 

forensic procedures related to their job 

duties) before they are permitted to 

work independently with federally 

regulated specimens. All training must 

be documented. 

Section 11.7 What security measures 

must an HHS-certified laboratory 

maintain? 

(a) An HHS-certified laboratory must 

control access to the drug testing 

facility, specimens, aliquots, and 

records. 

(b) Authorized visitors must be 

escorted at all times, except for 

individuals conducting inspections (i.e., 

for the Department, a Federal agency, a 

state, or other accrediting agency) or 

emergency personnel (e.g., firefighters 

and medical rescue teams). 

(c) An HHS-certified laboratory must 

maintain records documenting the 

identity of the visitor and escort, date, 

time of entry and exit, and purpose for 

access to the secured area. 


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Section 11.8 What are the laboratory 

chain of custody requirements for 

specimens and aliquots? 

(a) HHS-certified laboratories must 

use chain of custody procedures 

(internal and external) to maintain 

control and accountability of specimens 

from the time of receipt at the laboratory 

through completion of testing, reporting 

of results, during storage, and 

continuing until final disposition of the 

specimens. 

(b) HHS-certified laboratories must 

use chain of custody procedures to 

document the handling and transfer of 

aliquots throughout the testing process 

until final disposal. 

(c) The chain of custody must be 

documented using either paper copy or 

electronic procedures. 

(d) Each individual who handles a 

specimen or aliquot must sign and 

complete the appropriate entries on the 

chain of custody form when the 

specimen or aliquot is handled or 

transferred, and every individual in the 

chain must be identified. 

(e) The date and purpose must be 

recorded on an appropriate chain of 

custody form each time a specimen or 

aliquot is handled or transferred. 

Section 11.9 What test(s) does an 

HHS-certified laboratory conduct on a 

urine specimen received from an IITF? 

An HHS-certified laboratory must test 

the specimen in the same manner as a 

specimen that had not been previously 

tested. 

Section 11.10 What are the 

requirements for an initial drug test? 

(a) An initial drug test may be: 

(1) An immunoassay; or 

(2) An alternate technology (e.g., 

spectrometry, spectroscopy). 

(b) An HHS-certified laboratory must 

validate an initial drug test before 

testing specimens. 

(c) Initial drug tests must be accurate 

and reliable for the testing of specimens 

when identifying drugs or their 

metabolites. 

(d) An HHS-certified laboratory may 

conduct a second initial drug test using 

a method with different specificity, to 

rule out cross-reacting compounds. This 

second initial drug test must satisfy the 

batch quality control requirements 

specified in Section 11.12. 

Section 11.11 What must an HHScertified laboratory do to validate an 

initial drug test? 

(a) An HHS-certified laboratory must 

demonstrate and document the 

following for each initial drug test: 

(1) The ability to differentiate negative 

specimens from those requiring further 

testing; 

(2) The performance of the test around 

the cutoff, using samples at several 

concentrations between 0 and 150 

percent of the cutoff; 

(3) The effective concentration range 

of the test (linearity); 

(4) The potential for carryover; 

(5) The potential for interfering 

substances; and 

(6) The potential matrix effects if 

using an alternate technology. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) Each initial drug test using an 

alternate technology must be re-verified 

periodically or at least annually. 

Section 11.12 What are the batch 

quality control requirements when 

conducting an initial drug test? 

(a) Each batch of specimens must 

contain the following controls: 

(1) At least one control certified to 

contain no drug or drug metabolite; 

(2) At least one positive control with 

the drug or drug metabolite targeted at 

a concentration 25 percent above the 

cutoff; 

(3) At least one control with the drug 

or drug metabolite targeted at a 

concentration 75 percent of the cutoff; 

and 

(4) At least one control that appears 

as a donor specimen to the analysts. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 11.13 What are the 

requirements for a confirmatory drug 

test? 

(a) The analytical method must use 

mass spectrometric identification (e.g., 

gas chromatography-mass spectrometry 

[GC–MS], liquid chromatography-mass 

spectrometry [LC–MS], GC–MS/MS, 

LC–MS/MS) or equivalent. 

(b) A confirmatory drug test must be 

validated before it can be used to test 

federally regulated specimens. 

(c) Confirmatory drug tests must be 

accurate and reliable for the testing of a 

urine specimen when identifying and 

quantifying drugs or their metabolites. 

Section 11.14 What must an HHScertified laboratory do to validate a 

confirmatory drug test? 

(a) An HHS-certified laboratory must 

demonstrate and document the 

following for each confirmatory drug 

test: 

(1) The linear range of the analysis; 

(2) The limit of detection; 

(3) The limit of quantification; 

(4) The accuracy and precision at the 

cutoff; 

(5) The accuracy (bias) and precision 

at 40 percent of the cutoff; 

(6) The potential for interfering 

substances; 

(7) The potential for carryover; and 

(8) The potential matrix effects if 

using liquid chromatography coupled 

with mass spectrometry. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) HHS-certified laboratories must reverify each confirmatory drug test 

method periodically or at least annually. 

Section 11.15 What are the batch 

quality control requirements when 

conducting a confirmatory drug test? 

(a) At a minimum, each batch of 

specimens must contain the following 

calibrators and controls: 

(1) A calibrator at the cutoff; 

(2) At least one control certified to 

contain no drug or drug metabolite; 

(3) At least one positive control with 

the drug or drug metabolite targeted at 

25 percent above the cutoff; and 

(4) At least one control targeted at or 

less than 40 percent of the cutoff. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 11.16 What are the analytical 

and quality control requirements for 

conducting specimen validity tests? 

(a) Each invalid, adulterated, or 

substituted specimen validity test result 

must be based on an initial specimen 

validity test on one aliquot and a 

confirmatory specimen validity test on a 

second aliquot; 

(b) The HHS-certified laboratory must 

establish acceptance criteria and 

analyze calibrators and controls as 

appropriate to verify and document the 

validity of the test results (required 

specimen validity tests are addressed in 

Section 11.18); and 

(c) Controls must be analyzed 

concurrently with specimens. 

Section 11.17 What must an HHScertified laboratory do to validate a 

specimen validity test? 

An HHS-certified laboratory must 

demonstrate and document for each 

specimen validity test the appropriate 

performance characteristics of the test, 

and must re-verify the test periodically, 

or at least annually. Each new lot of 

reagent must be verified prior to being 

placed into service. 


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Section 11.18 What are the 

requirements for conducting each 

specimen validity test? 

(a) The requirements for measuring 

creatinine concentration are as follows: 

(1) The creatinine concentration must 

be measured to one decimal place on 

both the initial creatinine test and the 

confirmatory creatinine test; 

(2) The initial creatinine test must 

have the following calibrators and 

controls: 

(i) A calibrator at 2 mg/dL; 

(ii) A control in the range of 1.0 mg/ 

dL to 1.5 mg/dL; 

(iii) A control in the range of 3 mg/ 

dL to 20 mg/dL; and 

(iv) A control in the range of 21 mg/ 

dL to 25 mg/dL. 

(3) The confirmatory creatinine test 

(performed on those specimens with a 

creatinine concentration less than 2 mg/ 

dL on the initial test) must have the 

following calibrators and controls: 

(i) A calibrator at 2 mg/dL; 

(ii) A control in the range of 1.0 mg/ 

dL to 1.5 mg/dL; and 

(iii) A control in the range of 3 mg/ 

dL to 4 mg/dL. 

(b) The requirements for measuring 

specific gravity are as follows: 

(1) For specimens with initial 

creatinine test results greater than 5 mg/ 

dL and less than 20 mg/dL, laboratories 

may perform a screening test using a 

refractometer that measures urine 

specific gravity to at least three decimal 

places to identify specific gravity values 

that are acceptable (equal to or greater 

than 1.003) or dilute (equal to or greater 

than 1.002 and less than 1.003). 

Specimens must be subjected to an 

initial specific gravity test using a four 

decimal place refractometer when the 

initial creatinine test result is less than 

or equal to 5 mg/dL or when the 

screening specific gravity test result 

using a three decimal place 

refractometer is less than 1.002. 

(2) The screening specific gravity test 

must have the following calibrators and 

controls: 

(i) A calibrator or control at 1.000; 

(ii) One control targeted at 1.002; 

(iii) One control in the range of 1.004 

to 1.018. 

(3) For the initial and confirmatory 

specific gravity tests, the refractometer 

must report and display specific gravity 

to four decimal places. The 

refractometer must be interfaced with a 

laboratory information management 

system (LIMS), computer, and/or 

generate a paper copy of the digital 

electronic display to document the 

numerical values of the specific gravity 

test results; 

(4) The initial and confirmatory 

specific gravity tests must have the 

following calibrators and controls: 

(i) A calibrator or control at 1.0000; 

(ii) One control targeted at 1.0020; 

(iii) One control in the range of 1.0040 

to 1.0180; and 

(iv) One control equal to or greater 

than 1.0200 but not greater than 1.0250. 

(c) Requirements for measuring pH 

are as follows: 

(1) Colorimetric pH tests that have the 

dynamic range of 3 to 12 to support the 

4 and 11 pH cutoffs and pH meters must 

be capable of measuring pH to one 

decimal place. Colorimetric pH tests, 

dipsticks, and pH paper (i.e., screening 

tests) that have a narrow dynamic range 

and do not support the cutoffs may be 

used only to determine if an initial pH 

specimen validity test must be 

performed; 

(2) For the initial and confirmatory 

pH tests, the pH meter must report and 

display pH to at least one decimal place. 

The pH meter must be interfaced with 

a LIMS, computer, and/or generate a 

paper copy of the digital electronic 

display to document the numerical 

values of the pH test results; 

(3) pH screening tests must have, at a 

minimum, the following controls: 

(i) One control below the lower 

decision point in use; 

(ii) One control between the decision 

points in use; and 

(iii) One control above the upper 

decision point in use; 

(4) An initial colorimetric pH test 

must have the following calibrators and 

controls: 

(i) One calibrator at 4; 

(ii) One calibrator at 11; 

(iii) One control in the range of 3 to 

3.8; 

(iv) One control in the range 4.2 to 5; 

(v) One control in the range of 5 to 9; 

(vi) One control in the range of 10 to 

10.8; and 

(vii) One control in the range of 11.2 

to 12; 

(5) An initial pH meter test, if a pH 

screening test is not used, must have the 

following calibrators and controls: 

(i) One calibrator at 3; 

(ii) One calibrator at 7; 

(iii) One calibrator at 10; 

(iv) One control in the range of 3 to 

3.8; 

(v) One control in the range 4.2 to 5; 

(vi) One control in the range of 10 to 

10.8; and 

(vii) One control in the range of 11.2 

to 12; 

(6) An initial pH meter test (if a pH 

screening test is used) or confirmatory 

pH meter test must have the following 

calibrators and controls when the result 

of the preceding pH test indicates that 

the pH is below the lower decision 

point in use: 

(i) One calibrator at 4; 

(ii) One calibrator at 7; 

(iii) One control in the range of 3 to 

3.8; and 

(iv) One control in the range 4.2 to 5; 

and 

(7) An initial pH meter test (if a pH 

screening test is used) or confirmatory 

pH meter test must have the following 

calibrators and controls when the result 

of the preceding pH test indicates that 

the pH is above the upper decision 

point in use: 

(i) One calibrator at 7; 

(ii) One calibrator at 10; 

(iii) One control in the range of 10 to 

10.8; and 

(iv) One control in the range of 11.2 

to 12. 

(d) Requirements for performing 

oxidizing adulterant tests are as follows: 

(1) The initial test must include an 

appropriate calibrator at the cutoff 

specified in Section 11.19(d)(2), (3), or 

(4) for the compound of interest, a 

control without the compound of 

interest (i.e., a certified negative 

control), and at least one control with 

one of the compounds of interest at a 

measurable concentration; and 

(2) A confirmatory test for a specific 

oxidizing adulterant must use a 

different analytical method than that 

used for the initial test. Each 

confirmatory test batch must include an 

appropriate calibrator, a control without 

the compound of interest (i.e., a 

certified negative control), and a control 

with the compound of interest at a 

measurable concentration. 

(e) The requirements for measuring 

the nitrite concentration are that the 

initial and confirmatory nitrite tests 

must have a calibrator at the cutoff, a 

control without nitrite (i.e., certified 

negative urine), one control in the range 

of 200 mcg/mL to 250 mcg/mL, and one 

control in the range of 500 mcg/mL to 

625 mcg/mL. 

Section 11.19 What are the 

requirements for an HHS-certified 

laboratory to report a test result? 

(a) Laboratories must report a test 

result to the agency’s MRO within an 

average of 5 working days after receipt 

of the specimen. Reports must use the 

Federal CCF and/or an electronic report, 

as described in items p and q below. 

Before any test result can be reported, it 

must be certified by a certifying scientist 

or a certifying technician (as 

appropriate). 

(b) A primary (A) specimen is 

reported negative when each initial drug 

test is negative or if the specimen is 

negative upon confirmatory drug 


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testing, and the specimen does not meet 

invalid criteria as described in Section 

11.19(h)(1) through (13). 

(c) A primary (A) specimen is 

reported positive for a specific drug or 

drug metabolite when both the initial 

drug test is positive and the 

confirmatory drug test is positive in 

accordance with the cutoffs listed in the 

drug testing panel. 

(d) A primary (A) urine specimen is 

reported adulterated when: 

(1) The pH is less than 4 or equal to 

or greater than 11 using either a pH 

meter or a colorimetric pH test for the 

initial test on the first aliquot and a pH 

meter for the confirmatory test on the 

second aliquot; 

(2) The nitrite concentration is equal 

to or greater than 500 mcg/mL using 

either a nitrite colorimetric test or a 

general oxidant colorimetric test for the 

initial test on the first aliquot and a 

different confirmatory test (e.g., multiwavelength spectrophotometry, ion 

chromatography, capillary 

electrophoresis) on the second aliquot; 

(3) The presence of chromium (VI) is 

verified using either a general oxidant 

colorimetric test (with an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or a chromium (VI) 

colorimetric test (chromium (VI) 

concentration equal to or greater than 50 

mcg/mL) for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., multi-wavelength 

spectrophotometry, ion 

chromatography, atomic absorption 

spectrophotometry, capillary 

electrophoresis, inductively coupled 

plasma-mass spectrometry) with the 

chromium (VI) concentration equal to or 

greater than the LOQ of the 

confirmatory test on the second aliquot; 

(4) The presence of halogen (e.g., 

chlorine from bleach, iodine, fluoride) is 

verified using either a general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or halogen 

colorimetric test (halogen concentration 

equal to or greater than the LOQ) for the 

initial test on the first aliquot and a 

different confirmatory test (e.g., multiwavelength spectrophotometry, ion 

chromatography, inductively coupled 

plasma-mass spectrometry) with a 

specific halogen concentration equal to 

or greater than the LOQ of the 

confirmatory test on the second aliquot; 

(5) The presence of glutaraldehyde is 

verified using either an aldehyde test 

(aldehyde present) or the characteristic 

immunoassay response on one or more 

drug immunoassay tests for the initial 

test on the first aliquot and a different 

confirmatory method (e.g., GC/MS) for 

the confirmatory test with the 

glutaraldehyde concentration equal to or 

greater than the LOQ of the analysis on 

the second aliquot; 

(6) The presence of pyridine 

(pyridinium chlorochromate) is verified 

using either a general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or a chromium (VI) 

colorimetric test (chromium (VI) 

concentration equal to or greater than 50 

mcg/mL) for the initial test on the first 

aliquot and a different confirmatory 

method (e.g., GC/MS) for the 

confirmatory test with the pyridine 

concentration equal to or greater than 

the LOQ of the analysis on the second 

aliquot; 

(7) The presence of a surfactant is 

verified by using a surfactant 

colorimetric test with an equal to or 

greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., multi-wavelength 

spectrophotometry) with an equal to or 

greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff on the second aliquot; or 

(8) The presence of any other 

adulterant not specified in Section 

11.19(d)(2) through (7) is verified using 

an initial test on the first aliquot and a 

different confirmatory test on the 

second aliquot. 

(e) A primary (A) urine specimen is 

reported substituted when: 

(1) The creatinine concentration is 

less than 2 mg/dL and the specific 

gravity is less than or equal to 1.0010 or 

equal to or greater than 1.0200 on both 

the initial and confirmatory creatinine 

tests (i.e., the same colorimetric test may 

be used to test both aliquots) and on 

both the initial and confirmatory 

specific gravity tests (i.e., a 

refractometer is used to test both 

aliquots) on two separate aliquots; or 

(2) A biomarker is not present or is 

present at a concentration inconsistent 

with that established for human urine. 

(f) A primary (A) urine specimen is 

reported dilute when the creatinine 

concentration is equal to or greater than 

2 mg/dL but less than 20 mg/dL and the 

specific gravity is greater than 1.0010 

but less than 1.0030 on a single aliquot. 

(g) For a specimen that has an invalid 

result for one of the reasons stated in 

Section 11.19(h)(4) through (13), the 

HHS-certified laboratory shall contact 

the MRO and both will decide if testing 

by another HHS-certified laboratory 

would be useful in being able to report 

a positive, adulterated, or substituted 

result. If no further testing is necessary, 

the HHS-certified laboratory then 

reports the invalid result to the MRO. 

(h) A primary (A) urine specimen is 

reported as an invalid result when: 

(1) Inconsistent creatinine 

concentration and specific gravity 

results are obtained (i.e., the creatinine 

concentration is less than 2 mg/dL on 

both the initial and confirmatory 

creatinine tests and the specific gravity 

is greater than 1.0010 but less than 

1.0200 on the initial and/or 

confirmatory specific gravity test, the 

specific gravity is less than or equal to 

1.0010 on both the initial and 

confirmatory specific gravity tests and 

the creatinine concentration is equal to 

or greater than 2 mg/dL on either or 

both the initial or confirmatory 

creatinine tests); 

(2) The pH is equal to or greater than 

4 and less than 4.5 or equal to or greater 

than 9 and less than 11 using either a 

colorimetric pH test or pH meter for the 

initial test and a pH meter for the 

confirmatory test on two separate 

aliquots; 

(3) The nitrite concentration is equal 

to or greater than 200 mcg/mL using a 

nitrite colorimetric test or equal to or 

greater than the equivalent of 200 mcg/ 

mL nitrite using a general oxidant 

colorimetric test for both the initial 

(first) test and the second test or using 

either initial test and the nitrite 

concentration is equal to or greater than 

200 mcg/mL but less than 500 mcg/mL 

for a different confirmatory test (e.g., 

multi-wavelength spectrophotometry, 

ion chromatography, capillary 

electrophoresis) on two separate 

aliquots; 

(4) The possible presence of 

chromium (VI) is determined using the 

same chromium (VI) colorimetric test 

with a cutoff equal to or greater than 50 

mcg/mL chromium (VI) for both the 

initial (first) test and the second test on 

two separate aliquots; 

(5) The possible presence of a halogen 

(e.g., chlorine from bleach, iodine, 

fluoride) is determined using the same 

halogen colorimetric test with a cutoff 

equal to or greater than the LOQ for both 

the initial (first) test and the second test 

on two separate aliquots or relying on 

the odor of the specimen as the initial 

test; 

(6) The possible presence of 

glutaraldehyde is determined by using 

the same aldehyde test (aldehyde 

present) or characteristic immunoassay 

response on one or more drug 

immunoassay tests for both the initial 

(first) test and the second test on two 

separate aliquots; 


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(7) The possible presence of an 

oxidizing adulterant is determined by 

using the same general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent cutoff, an equal to or greater 

than 50 mcg/mL chromium (VI)- 

equivalent cutoff, or a halogen 

concentration is equal to or greater than 

the LOQ) for both the initial (first) test 

and the second test on two separate 

aliquots; 

(8) The possible presence of a 

surfactant is determined by using the 

same surfactant colorimetric test with 

an equal to or greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff for both the initial (first) test and 

the second test on two separate aliquots 

or a foam/shake test for the initial test; 

(9) Interference occurs on the initial 

drug tests on two separate aliquots (i.e., 

valid initial drug test results cannot be 

obtained); 

(10) Interference with the 

confirmatory drug test occurs on at least 

two separate aliquots of the specimen 

and the HHS-certified laboratory is 

unable to identify the interfering 

substance; 

(11) The physical appearance of the 

specimen is such that testing the 

specimen may damage the laboratory’s 

instruments; 

(12) The physical appearances of the 

A and B specimens are clearly different 

(note: A is tested); or 

(13) A specimen validity test (i.e., 

other than the tests listed above) on two 

separate aliquots of the specimen 

indicates that the specimen is not valid 

for testing. 

(i) An HHS-certified laboratory shall 

reject a primary (A) specimen for testing 

when a fatal flaw occurs as described in 

Section 15.1 or when a correctable flaw 

as described in Section 15.2 is not 

recovered. The HHS-certified laboratory 

will indicate on the Federal CCF that 

the specimen was rejected for testing 

and provide the reason for reporting the 

rejected for testing result. 

(j) An HHS-certified laboratory must 

report all positive, adulterated, 

substituted, and invalid test results for 

a urine specimen. For example, a 

specimen can be positive for a drug and 

adulterated. 

(k) An HHS-certified laboratory must 

report the confirmatory concentration of 

each drug or drug metabolite reported 

for a positive result. 

(l) An HHS-certified laboratory must 

report numerical values of the specimen 

validity test results that support an 

adulterated, substituted, or invalid 

result (as appropriate). 

(m) An HHS-certified laboratory must 

report results using the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels. 

(n) When the concentration of a drug 

or drug metabolite exceeds the validated 

linear range of the confirmatory test, 

HHS-certified laboratories may report to 

the MRO that the quantitative value 

exceeds the linear range of the test or 

that the quantitative value is greater 

than ‘‘insert the actual value for the 

upper limit of the linear range,’’ or 

laboratories may report a quantitative 

value above the upper limit of the linear 

range that was obtained by diluting an 

aliquot of the specimen to achieve a 

result within the method’s linear range 

and multiplying the result by the 

appropriate dilution factor. 

(o) HHS-certified laboratories may 

transmit test results to the MRO by 

various electronic means (e.g., fax, 

computer). Transmissions of the reports 

must ensure confidentiality and the 

results may not be reported verbally by 

telephone. Laboratories and external 

service providers must ensure the 

confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(p) HHS-certified laboratories must 

fax, courier, mail, or electronically 

transmit a legible image or copy of the 

completed Federal CCF and/or forward 

a computer-generated electronic report. 

The computer-generated report must 

contain sufficient information to ensure 

that the test results can accurately 

represent the content of the custody and 

control form that the MRO received 

from the collector. 

(q) For positive, adulterated, 

substituted, invalid, and rejected 

specimens, laboratories must fax, 

courier, mail, or electronically transmit 

a legible image or copy of the completed 

Federal CCF. 

Section 11.20 How long must an HHScertified laboratory retain specimens? 

(a) An HHS-certified laboratory must 

retain specimens that were reported as 

positive, adulterated, substituted, or as 

an invalid result for a minimum of 1 

year. 

(b) Retained urine specimens must be 

kept in secured frozen storage (-20°C or 

less) to ensure their availability for 

retesting during an administrative or 

judicial proceeding. 

(c) Federal agencies may request that 

the HHS-certified laboratory retain a 

specimen for an additional specified 

period of time and must make that 

request within the 1-year period 

following the laboratory’s reporting of 

the specimen. 

Section 11.21 How long must an HHScertified laboratory retain records? 

(a) An HHS-certified laboratory must 

retain all records generated to support 

test results for at least 2 years. The 

laboratory may convert hardcopy 

records to electronic records for storage 

and then discard the hardcopy records 

after 6 months. 

(b) A Federal agency may request the 

HHS-certified laboratory to maintain a 

documentation package (as described in 

Section 11.23) that supports the chain of 

custody, testing, and reporting of a 

donor’s specimen that is under legal 

challenge by a donor. The Federal 

agency’s request to the laboratory must 

be in writing and must specify the 

period of time to maintain the 

documentation package. 

(c) An HHS-certified laboratory may 

retain records other than those included 

in the documentation package beyond 

the normal 2-year period of time. 

Section 11.22 What statistical 

summary reports must an HHS-certified 

laboratory provide for urine testing? 

(a) HHS-certified laboratories must 

provide to each Federal agency for 

which they perform testing a 

semiannual statistical summary report 

that must be submitted by mail, fax, or 

email within 14 working days after the 

end of the semiannual period. The 

summary report must not include any 

personally identifiable information. A 

copy of the semiannual statistical 

summary report will also be sent to the 

Secretary or designated HHS 

representative. The semiannual 

statistical report contains the following 

information: 

(1) Reporting period (inclusive dates); 

(2) HHS-certified laboratory name and 

address; 

(3) Federal agency name; 

(4) Number of specimen results 

reported; 

(5) Number of specimens collected by 

reason for test; 

(6) Number of specimens reported 

negative and the number reported 

negative/dilute; 

(7) Number of specimens rejected for 

testing because of a fatal flaw; 

(8) Number of specimens rejected for 

testing because of an uncorrected flaw; 

(9) Number of specimens tested 

positive by each initial drug test; 

(10) Number of specimens reported 

positive; 

(11) Number of specimens reported 

positive for each drug and drug 

metabolite; 

(12) Number of specimens reported 

adulterated; 

(13) Number of specimens reported 

substituted; and 


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(14) Number of specimens reported as 

invalid result. 

(b) An HHS-certified laboratory must 

make copies of an agency’s test results 

available when requested to do so by the 

Secretary or by the Federal agency for 

which the laboratory is performing 

drug-testing services. 

(c) An HHS-certified laboratory must 

ensure that a qualified individual is 

available to testify in a proceeding 

against a Federal employee when the 

proceeding is based on a test result 

reported by the laboratory. 

Section 11.23 What HHS-certified 

laboratory information is available to a 

Federal agency? 

(a) Following a Federal agency’s 

receipt of a positive, adulterated, or 

substituted drug test report, the Federal 

agency may submit a written request for 

copies of the records relating to the drug 

test results or a documentation package 

or any relevant certification, review, or 

revocation of certification records. 

(b) Standard documentation packages 

provided by an HHS-certified laboratory 

must contain the following items: 

(1) A cover sheet providing a brief 

description of the procedures and tests 

performed on the donor’s specimen; 

(2) A table of contents that lists all 

documents and materials in the package 

by page number; 

(3) A copy of the Federal CCF with 

any attachments, internal chain of 

custody records for the specimen, 

memoranda (if any) generated by the 

HHS-certified laboratory, and a copy of 

the electronic report (if any) generated 

by the HHS-certified laboratory; 

(4) A brief description of the HHScertified laboratory’s initial drug and 

specimen validity testing procedures, 

instrumentation, and batch quality 

control requirements; 

(5) Copies of the initial test data for 

the donor’s specimen with all 

calibrators and controls and copies of all 

internal chain of custody documents 

related to the initial tests; 

(6) A brief description of the HHScertified laboratory’s confirmatory drug 

(and specimen validity, if applicable) 

testing procedures, instrumentation, and 

batch quality control requirements; 

(7) Copies of the confirmatory test 

data for the donor’s specimen with all 

calibrators and controls and copies of all 

internal chain of custody documents 

related to the confirmatory tests; and 

(8) Copies of the re ́sume ́ or 

curriculum vitae for the RP(s) and the 

certifying technician or certifying 

scientist of record. 

Section 11.24 What HHS-certified 

laboratory information is available to a 

Federal employee? 

Federal applicants or employees who 

are subject to a workplace drug test may 

submit a written request through the 

MRO and/or the Federal agency 

requesting copies of any records relating 

to their drug test results or a 

documentation package as described in 

Section 11.23(b) and any relevant 

certification, review, or revocation of 

certification records. Federal applicants 

or employees, or their designees, are not 

permitted access to their specimens 

collected pursuant to Executive Order 

12564, Public Law 100–71, and these 

Guidelines. 

Section 11.25 What types of 

relationships are prohibited between an 

HHS-certified laboratory and an MRO? 

An HHS-certified laboratory must not 

enter into any relationship with a 

Federal agency’s MRO that may be 

construed as a potential conflict of 

interest or derive any financial benefit 

by having a Federal agency use a 

specific MRO. 

This means an MRO may be an 

employee of the agency or a contractor 

for the agency; however, an MRO shall 

not be an employee or agent of or have 

any financial interest in the HHScertified laboratory for which the MRO 

is reviewing drug testing results. 

Additionally, an MRO shall not derive 

any financial benefit by having an 

agency use a specific HHS-certified 

laboratory or have any agreement with 

an HHS-certified laboratory that may be 

construed as a potential conflict of 

interest. 

Section 11.26 What type of 

relationship can exist between an HHScertified laboratory and an HHScertified IITF? 

An HHS-certified laboratory can enter 

into any relationship with an HHScertified IITF. 

Subpart L—Instrumented Initial Test 

Facility (IITF) 

Section 12.1 What must be included in 

the HHS-certified IITF’s standard 

operating procedure manual? 

(a) An HHS-certified IITF must have 

a standard operating procedure (SOP) 

manual that describes, in detail, all 

HHS-certified IITF operations. When 

followed, the SOP manual ensures that 

all specimens are tested consistently 

using the same procedures. 

(b) The SOP manual must include at 

a minimum, but is not limited to, a 

detailed description of the following: 

(1) Chain of custody procedures; 

(2) Accessioning; 

(3) Security; 

(4) Quality control/quality assurance 

programs; 

(5) Analytical methods and 

procedures; 

(6) Equipment and maintenance 

programs; 

(7) Personnel training; 

(8) Reporting procedures; and 

(9) Computers, software, and 

laboratory information management 

systems. 

(c) All procedures in the SOP manual 

must be compliant with these 

Guidelines and all guidance provided 

by the Secretary. 

(d) A copy of all procedures that have 

been replaced or revised and the dates 

on which the procedures were in effect 

must be maintained for two years. 

Section 12.2 What are the 

responsibilities of the responsible 

technician (RT)? 

(a) Manage the day-to-day operations 

of the HHS-certified IITF even if another 

individual has overall responsibility for 

alternate areas of a multi-specialty 

facility. 

(b) Ensure that there are sufficient 

personnel with adequate training and 

experience to supervise and conduct the 

work of the HHS-certified IITF. The RT 

must ensure the continued competency 

of IITF personnel by documenting their 

in-service training, reviewing their work 

performance, and verifying their skills. 

(c) Maintain a complete and current 

SOP manual that is available to all 

personnel of the HHS-certified IITF, and 

ensure that it is followed. The SOP 

manual must be reviewed, signed, and 

dated by the RT when procedures are 

first placed into use or changed or when 

a new individual assumes responsibility 

for the management of the HHS-certified 

IITF. The SOP must be reviewed and 

documented by the RT annually. 

(d) Maintain a quality assurance 

program that ensures the proper 

performance and reporting of all test 

results; verify and monitor acceptable 

analytical performance for all controls 

and calibrators; monitor quality control 

testing; and document the validity, 

reliability, accuracy, precision, and 

performance characteristics of each test 

and test system. 

(e) Initiate and implement all 

remedial actions necessary to maintain 

satisfactory operation and performance 

of the HHS-certified IITF in response to 

the following: quality control systems 

not within performance specifications, 

errors in result reporting or in analysis 

of performance testing samples, and 

inspection deficiencies. The RT must 

ensure that specimen results are not 


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reported until all corrective actions have 

been taken and that the results provided 

are accurate and reliable. 

Section 12.3 What qualifications must 

the RT have? 

An RT must: 

(a) Have at least a bachelor’s degree in 

the chemical or biological sciences or 

medical technology, or equivalent; 

(b) Have training and experience in 

the analytical methods and forensic 

procedures used by the HHS-certified 

IITF; 

(c) Have training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise; 

(d) Be found to fulfill RT 

responsibilities and qualifications, as 

demonstrated by the HHS-certified 

IITF’s performance and verified upon 

interview by HHS-trained inspectors 

during each on-site inspection; and 

(e) Qualify as a certifying technician. 

Section 12.4 What happens when the 

RT is absent or leaves an HHS-certified 

IITF? 

(a) HHS-certified IITFs must have an 

RT and an alternate RT. When an RT is 

absent, an alternate RT must be present 

and qualified to fulfill the 

responsibilities of the RT. 

(1) If an HHS-certified IITF is without 

the RT and alternate RT for 14 calendar 

days or less (e.g., temporary absence due 

to vacation, illness, business trip), the 

HHS-certified IITF may continue 

operations and testing of Federal agency 

specimens under the direction of a 

certifying technician. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend an IITF’s 

HHS certification for all specimens if 

the IITF does not have an RT or 

alternate RT for a period of more than 

14 calendar days. The suspension will 

be lifted upon the Secretary’s approval 

of a new permanent RT or alternate RT. 

(b) If the RT leaves an HHS-certified 

IITF: 

(1) The HHS-certified IITF may 

maintain certification and continue 

testing federally regulated specimens 

under the direction of an alternate RT 

for a period of up to 180 days while 

seeking to hire and receive the 

Secretary’s approval of the RT’s 

replacement. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend an IITF’s 

HHS certification for all federally 

regulated specimens if the IITF does not 

have a permanent RT within 180 days. 

The suspension will be lifted upon the 

Secretary’s approval of the new 

permanent RT. 

(c) To nominate an individual as the 

RT or alternate RT, the HHS-certified 

IITF must submit the following 

documents to the Secretary: the 

candidate’s current resume or 

curriculum vitae, copies of diplomas 

and licensures, a training plan (not to 

exceed 90 days) to transition the 

candidate into the position, an itemized 

comparison of the candidate’s 

qualifications to the minimum RT 

qualifications described in the 

Guidelines, and have official academic 

transcript(s) submitted from the 

candidate’s institution(s) of higher 

learning. The candidate must be found 

qualified during an on-site inspection of 

the HHS-certified IITF. 

(d) The HHS-certified IITF must fulfill 

additional inspection and PT criteria as 

required prior to conducting federally 

regulated testing under a new RT. 

Section 12.5 What qualifications must 

an individual have to certify a result 

reported by an HHS-certified IITF? 

A certifying technician must have: 

(a) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

IITF relevant to the results that the 

individual certifies; and 

(b) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

Section 12.6 What qualifications and 

training must other personnel of an 

HHS-certified IITF have? 

(a) All HHS-certified IITF staff (e.g., 

technicians, administrative staff) must 

have the appropriate training and skills 

for the tasks they perform. 

(b) Each individual working in an 

HHS-certified IITF must be properly 

trained (i.e., receive training in each 

area of work that the individual will be 

performing, including training in 

forensic procedures related to their job 

duties) before they are permitted to 

work independently with federally 

regulated specimens. All training must 

be documented. 

Section 12.7 What security measures 

must an HHS-certified IITF maintain? 

(a) An HHS-certified IITF must 

control access to the drug testing 

facility, specimens, aliquots, and 

records. 

(b) Authorized visitors must be 

escorted at all times except for 

individuals conducting inspections (i.e., 

for the Department, a Federal agency, a 

state, or other accrediting agency) or 

emergency personnel (e.g., firefighters 

and medical rescue teams). 

(c) An HHS-certified IITF must 

maintain records documenting the 

identity of the visitor and escort, date, 

time of entry and exit, and purpose for 

the access to the secured area. 

Section 12.8 What are the IITF chain 

of custody requirements for specimens 

and aliquots? 

(a) HHS-certified IITFs must use chain 

of custody procedures (internal and 

external) to maintain control and 

accountability of specimens from the 

time of receipt at the IITF through 

completion of testing, reporting of 

results, during storage, and continuing 

until final disposition of the specimens. 

(b) HHS-certified IITFs must use 

chain of custody procedures to 

document the handling and transfer of 

aliquots throughout the testing process 

until final disposal. 

(c) The chain of custody must be 

documented using either paper copy or 

electronic procedures. 

(d) Each individual who handles a 

specimen or aliquot must sign and 

complete the appropriate entries on the 

chain of custody form when the 

specimen or aliquot is handled or 

transferred, and every individual in the 

chain must be identified. 

(e) The date and purpose must be 

recorded on an appropriate chain of 

custody form each time a specimen or 

aliquot is handled or transferred. 

Section 12.9 What are the 

requirements for an initial drug test? 

(a) An initial drug test may be: 

(1) An immunoassay; or 

(2) An alternate technology (e.g., 

spectrometry, spectroscopy). 

(b) An HHS-certified IITF must 

validate an initial drug test before 

testing specimens; 

(c) Initial drug tests must be accurate 

and reliable for the testing of urine 

specimens when identifying drugs or 

their metabolites. 

(d) An HHS-certified IITF may 

conduct a second initial drug test using 

a method with different specificity, to 

rule out cross-reacting compounds. This 

second initial drug test must satisfy the 

batch quality control requirements 

specified in Section 12.11. 

Section 12.10 What must an HHScertified IITF do to validate an initial 

drug test? 

(a) An HHS-certified IITF must 

demonstrate and document the 

following for each initial drug test: 

(1) The ability to differentiate negative 

specimens from those requiring further 

testing; 


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(2) The performance of the test around 

the cutoff, using samples at several 

concentrations between 0 and 150 

percent of the cutoff; 

(3) The effective concentration range 

of the test (linearity); 

(4) The potential for carryover; 

(5) The potential for interfering 

substances; and 

(6) The potential matrix effects if 

using an alternate technology. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) Each initial drug test using an 

alternate technology must be re-verified 

periodically or at least annually. 

Section 12.11 What are the batch 

quality control requirements when 

conducting an initial drug test? 

(a) Each batch of specimens must 

contain the following calibrators and 

controls: 

(1) At least one control certified to 

contain no drug or drug metabolite; 

(2) At least one positive control with 

the drug or drug metabolite targeted at 

a concentration 25 percent above the 

cutoff; 

(3) At least one control with the drug 

or drug metabolite targeted at a 

concentration 75 percent of the cutoff; 

and 

(4) At least one control that appears 

as a donor specimen to the analysts. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 12.12 What are the analytical 

and quality control requirements for 

conducting specimen validity tests? 

(a) Each specimen validity test result 

must be based on performing a single 

test on one aliquot; 

(b) The HHS-certified IITF must 

establish acceptance criteria and 

analyze calibrators and controls as 

appropriate to verify and document the 

validity of the test results in accordance 

with Section 12.14; and 

(c) Controls must be analyzed 

concurrently with specimens. 

Section 12.13 What must an HHScertified IITF do to validate a specimen 

validity test? 

An HHS-certified IITF must 

demonstrate and document for each 

specimen validity test the appropriate 

performance characteristics of the test, 

and must re-verify the test periodically, 

or at least annually. Each new lot of 

reagent must be verified prior to being 

placed into service. 

Section 12.14 What are the 

requirements for conducting each 

specimen validity test? 

(a) The requirements for measuring 

creatinine concentration are as follows: 

(1) The creatinine concentration must 

be measured to one decimal place on 

the test; 

(2) The creatinine test must have the 

following calibrators and controls: 

(i) A calibrator at 2 mg/dL; 

(ii) A control in the range of 1.0 mg/ 

dL to 1.5 mg/dL; 

(iii) A control in the range of 3 mg/ 

dL to 20 mg/dL; and 

(iv) A control in the range of 21 mg/ 

dL to 25 mg/dL. 

(b) The requirements for measuring 

specific gravity are as follows: 

(1) For specimens with creatinine test 

results greater than 5 mg/dL and less 

than 20 mg/dL, an IITF must perform a 

screening test using a refractometer to 

identify specific gravity values that are 

acceptable (equal to or greater 

than1.003) or dilute (equal to or greater 

than1.002 and less than1.003). 

Specimens must be forwarded to an 

HHS-certified laboratory when the 

creatinine test result is less than or 

equal to 5 mg/dL or when the screening 

specific gravity test result is less than 

1.002. 

(2) The screening specific gravity test 

must have the following calibrators and 

controls: 

(i) A calibrator or control at 1.000; 

(ii) One control targeted at 1.002; and 

(iii) One control in the range of 1.004 

to 1.018. 

(c) The requirements for measuring 

pH are as follows: 

(1) The IITF may perform the pH test 

using a pH meter, colorimetric pH test, 

dipsticks, or pH paper. Specimens must 

be forwarded to an HHS-certified 

laboratory when the pH is less than 4.5 

or equal to or greater than 9.0. 

(2) The pH test must have, at a 

minimum, the following calibrators and 

controls: 

(i) One control below 4.5; 

(ii) One control between 4.5 and 9.0; 

(iii) One control above 9.0; and 

(iv) One or more calibrators as 

appropriate for the test. For a pH meter: 

calibrators at 4, 7, and 10. 

(d) The requirements for measuring 

the nitrite concentration are that the 

nitrite test must have a calibrator at 200 

mcg/mL nitrite, a control without nitrite 

(i.e., certified negative urine), one 

control in the range of 200 mcg/mL to 

250 mcg/mL, and one control in the 

range of 500 mcg/mL to 625 mcg/mL. 

Specimens with a nitrite concentration 

equal to or greater than 200 mcg/mL 

must be forwarded to an HHS-certified 

laboratory; and, 

(e) Requirements for performing 

oxidizing adulterant tests are that the 

test must include an appropriate 

calibrator at the cutoff specified in 

Section 11.19(d)(3), (4), or (6) for the 

compound of interest, a control without 

the compound of interest (i.e., a 

certified negative control), and at least 

one control with one of the compounds 

of interest at a measurable 

concentration. Specimens with an 

oxidizing adulterant result equal to or 

greater than the cutoff must be 

forwarded to an HHS-certified 

laboratory. 

Section 12.15 What are the 

requirements for an HHS-certified IITF 

to report a test result? 

(a) An HHS-certified IITF must report 

a test result to the agency’s MRO within 

an average of 3 working days after 

receipt of the specimen. Reports must 

use the Federal CCF and/or an 

electronic report. Before any test result 

can be reported, it must be certified by 

a certifying technician. 

(b) A primary (A) specimen is 

reported negative when each drug test is 

negative and each specimen validity test 

result indicates that the specimen is a 

valid urine specimen. 

(c) A primary (A) urine specimen is 

reported dilute when the creatinine 

concentration is greater than 5 mg/dL 

but less than 20 mg/dL and the specific 

gravity is equal to or greater than 1.002 

but less than 1.003. 

(d) An HHS-certified IITF shall reject 

a urine specimen for testing when a fatal 

flaw occurs as described in Section 15.1 

or when a correctable flaw as described 

in Section 15.2 is not recovered. The 

HHS-certified IITF will indicate on the 

Federal CCF that the specimen was 

rejected for testing and provide the 

reason for reporting the rejected for 

testing result. 

(e) An HHS-certified IITF must report 

results using the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels. 

(f) HHS-certified IITFs may transmit 

test results to the MRO by various 

electronic means (e.g., fax, computer). 

Transmissions of the reports must 

ensure confidentiality and the results 

may not be reported verbally by 

telephone. IITFs and external service 

providers must ensure the 

confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(g) HHS-certified IITFs must fax, 

courier, mail, or electronically transmit 

a legible image or copy of the completed 

Federal CCF and/or forward a computergenerated electronic report. The 


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computer-generated report must contain 

sufficient information to ensure that the 

test results can accurately represent the 

content of the custody and control form 

that the MRO received from the 

collector. 

(h) For rejected specimens, IITFs must 

fax, courier, mail, or electronically 

transmit a legible image or copy of the 

completed Federal CCF. 

Section 12.16 How does an HHScertified IITF handle a specimen that 

tested positive, adulterated, substituted, 

or invalid at the IITF? 

(a) The remaining specimen is 

resealed using a tamper-evident label/ 

seal; 

(b) The individual resealing the 

remaining specimen initials and dates 

the tamper-evident label/seal; and 

(c) The resealed specimen and split 

specimen and the Federal CCF are 

sealed in a leak-proof plastic bag, and 

are sent to an HHS-certified laboratory 

under chain of custody within one day 

after completing the drug and specimen 

validity tests. 

Section 12.17 How long must an HHScertified IITF retain a specimen? 

A specimen that is negative, negative/ 

dilute, or rejected for testing is 

discarded. 

Section 12.18 How long must an HHScertified IITF retain records? 

(a) An HHS-certified IITF must retain 

all records generated to support test 

results for at least 2 years. The IITF may 

convert hardcopy records to electronic 

records for storage and then discard the 

hardcopy records after six months. 

(b) A Federal agency may request the 

HHS-certified IITF to maintain a 

documentation package (as described in 

Section 12.20) that supports the chain of 

custody, testing, and reporting of a 

donor’s specimen that is under legal 

challenge by a donor. The Federal 

agency’s request to the IITF must be in 

writing and must specify the period of 

time to maintain the documentation 

package. 

(c) An HHS-certified IITF may retain 

records other than those included in the 

documentation package beyond the 

normal two-year period of time. 

Section 12.19 What statistical 

summary reports must an HHS-certified 

IITF provide? 

(a) HHS-certified IITFs must provide 

to each Federal agency for which they 

perform testing a semiannual statistical 

summary report that must be submitted 

by mail, fax, or email within 14 working 

days after the end of the semiannual 

period. The summary report must not 

include any personally identifiable 

information. A copy of the semiannual 

statistical summary report will also be 

sent to the Secretary or designated HHS 

representative. The semiannual 

statistical report contains the following 

information: 

(1) Reporting period (inclusive dates); 

(2) HHS-certified IITF name and 

address; 

(3) Federal agency name; 

(4) Total number of specimens tested; 

(5) Number of specimens collected by 

reason for test; 

(6) Number of specimens reported 

negative and the number reported 

negative/dilute; 

(7) Number of specimens rejected for 

testing because of a fatal flaw; 

(8) Number of specimens rejected for 

testing because of an uncorrected flaw; 

(9) Number of specimens tested 

positive by each initial drug test; and 

(10) Number of specimens forwarded 

to an HHS-certified laboratory for 

testing. 

(b) An HHS-certified IITF must make 

copies of an agency’s test results 

available when requested to do so by the 

Secretary or by the Federal agency for 

which the IITF is performing drugtesting services. 

(c) An HHS-certified IITF must ensure 

that a qualified individual is available to 

testify in a proceeding against a Federal 

employee when the proceeding is based 

on a test result reported by the IITF. 

Section 12.20 What HHS-certified IITF 

information is available to a Federal 

agency? 

(a) Following a Federal agency’s 

receipt of a positive, adulterated, or 

substituted drug test report from a 

laboratory, the Federal agency may 

submit a written request for copies of 

the IITF records relating to the drug test 

results or a documentation package or 

any relevant certification, review, or 

revocation of certification records. 

(b) Standard documentation packages 

provided by an HHS-certified IITF must 

contain the following items: 

(1) A cover sheet providing a brief 

description of the procedures and tests 

performed on the donor’s specimen; 

(2) A table of contents that lists all 

documents and materials in the package 

by page number; 

(3) A copy of the Federal CCF with 

any attachments, internal chain of 

custody records for the specimen, 

memoranda (if any) generated by the 

HHS-certified IITF, and a copy of the 

electronic report (if any) generated by 

the HHS-certified IITF; 

(4) A brief description of the HHScertified IITF’s drug and specimen 

validity testing procedures, 

instrumentation, and batch quality 

control requirements; 

(5) Copies of all test data for the 

donor’s specimen with all calibrators 

and controls and copies of all internal 

chain of custody documents related to 

the tests; and 

(6) Copies of the re ́sume ́ or 

curriculum vitae for the RT and for the 

certifying technician of record. 

Section 12.21 What HHS-certified IITF 

information is available to a Federal 

employee? 

A Federal employee who is the 

subject of a drug test may provide a 

written request through the MRO and/ 

or the Federal agency requesting access 

to any records relating to the employee’s 

drug test results or a documentation 

package (as described in Section 12.20) 

and any relevant certification, review, or 

revocation of certification records. 

Section 12.22 What types of 

relationships are prohibited between an 

HHS-certified IITF and an MRO? 

An HHS-certified IITF must not enter 

into any relationship with a Federal 

agency’s MRO that may be construed as 

a potential conflict of interest or derive 

any financial benefit by having a 

Federal agency use a specific MRO. 

This means an MRO may be an 

employee of the agency or a contractor 

for the agency; however, an MRO shall 

not be an employee or agent of or have 

any financial interest in the HHScertified IITF for which the MRO is 

reviewing drug testing results. 

Additionally, an MRO shall not derive 

any financial benefit by having an 

agency use a specific HHS-certified IITF 

or have any agreement with an HHScertified IITF that may be construed as 

a potential conflict of interest. 

Section 12.23 What type of 

relationship can exist between an HHScertified IITF and an HHS-certified 

laboratory? 

An HHS-certified IITF can enter into 

any relationship with an HHS-certified 

laboratory. 

Subpart M—Medical Review Officer 

(MRO) 

Section 13.1 Who may serve as an 

MRO? 

(a) A currently licensed physician 

who has: 

(1) A Doctor of Medicine (M.D.) or 

Doctor of Osteopathy (D.O.) degree; 

(2) Knowledge regarding the 

pharmacology and toxicology of illicit 

drugs; 

(3) The training necessary to serve as 

an MRO as set out in Section 13.3; 


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(4) Satisfactorily passed an initial 

examination administered by a 

nationally recognized entity or a 

subspecialty board that has been 

approved by the Secretary to certify 

MROs; and 

(5) At least every five years from 

initial certification, completed 

requalification training on the topics in 

Section 13.3 and satisfactorily passed a 

requalification examination 

administered by a nationally recognized 

entity or a subspecialty board that has 

been approved by the Secretary to 

certify MROs. 

Section 13.2 How are nationally 

recognized entities or subspecialty 

boards that certify MROs approved? 

All nationally recognized entities or 

subspecialty boards which seek 

approval by the Secretary to certify 

physicians as MROs for Federal 

workplace drug testing programs must 

submit their qualifications, a sample 

examination, and other necessary 

supporting examination materials (e.g., 

answers, previous examination statistics 

or other background examination 

information, if requested). Approval 

will be based on an objective review of 

qualifications that include a copy of the 

MRO applicant application form, 

documentation that the continuing 

education courses are accredited by a 

professional organization, and the 

delivery method and content of the 

examination. Each approved MRO 

certification entity must resubmit their 

qualifications for approval every two 

years. The Secretary shall publish at 

least every two years a notification in 

the Federal Register listing those 

entities and subspecialty boards that 

have been approved. This notification is 

also available on the internet at https:// 

www.samhsa.gov/workplace. 

Section 13.3 What training is required 

before a physician may serve as an 

MRO? 

(a) A physician must receive training 

that includes a thorough review of the 

following: 

(1) The collection procedures used to 

collect Federal agency specimens; 

(2) How to interpret test results 

reported by HHS-certified IITFs and 

laboratories (e.g., negative, negative/ 

dilute, positive, adulterated, substituted, 

rejected for testing, and invalid); 

(3) Chain of custody, reporting, and 

recordkeeping requirements for Federal 

agency specimens; 

(4) The HHS Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs for all authorized specimen 

types; and 

(5) Procedures for interpretation, 

review (e.g., donor interview for 

legitimate medical explanations, review 

of documentation provided by the donor 

to support a legitimate medical 

explanation), and reporting of results 

specified by any Federal agency for 

which the individual may serve as an 

MRO; 

(b) Certified MROs must complete 

training on any revisions to these 

Guidelines including any changes to the 

drug and biomarker testing panels prior 

to their effective date, to continue 

serving as an MRO for Federal agency 

specimens. 

Section 13.4 What are the 

responsibilities of an MRO? 

(a) The MRO must review all positive, 

adulterated, rejected for testing, invalid, 

and substituted test results. 

(b) Staff under the direct, personal 

supervision of the MRO may review and 

report negative and (for urine) negative/ 

dilute test results to the agency’s 

designated representative. The MRO 

must review at least 5 percent of all 

negative results reported by the MRO 

staff to ensure that the MRO staff are 

properly performing the review process. 

(c) The MRO must discuss potential 

invalid results with the HHS-certified 

laboratory, as addressed in Section 

11.19(g) to determine whether testing at 

another HHS-certified laboratory may be 

warranted. 

(d) After receiving a report from an 

HHS-certified laboratory or (for urine) 

HHS-certified IITF, the MRO must: 

(1) Review the information on the 

MRO copy of the Federal CCF that was 

received from the collector and the 

report received from the HHS-certified 

laboratory or HHS-certified IITF; 

(2) Interview the donor when 

required; 

(3) Make a determination regarding 

the test result; and 

(4) Report the verified result to the 

Federal agency. 

(e) The MRO must maintain records 

for a minimum of two years while 

maintaining the confidentiality of the 

information. The MRO may convert 

hardcopy records to electronic records 

for storage and discard the hardcopy 

records after six months. 

(f) The MRO must conduct a medical 

examination or a review of the 

examining physician’s findings and 

make a determination of refusal to test 

or cancelled test when a collector 

reports that the donor was unable to 

provide a specimen and an alternate 

specimen was not collected, as 

addressed in Sections 8.6 and 13.6. 

Section 13.5 What must an MRO do 

when reviewing a urine specimen’s test 

results? 

(a) When the HHS-certified laboratory 

or HHS-certified IITF reports a negative 

result for the primary (A) specimen, the 

MRO reports a negative result to the 

agency. 

(b) When the HHS-certified laboratory 

or HHS-certified IITF reports a negative/ 

dilute result for the primary (A) urine 

specimen, the MRO reports a negative/ 

dilute result to the agency and directs 

the agency to immediately collect 

another specimen from the donor. 

(1) If the recollected specimen 

provides a negative or negative/dilute 

result, the MRO reports a negative result 

to the agency, with no further action 

required. 

(2) If the recollected specimen 

provides a result other than negative or 

negative/dilute, the MRO follows the 

procedures in Section 13.5(c) through (f) 

for the recollected specimen. 

(c) When the HHS-certified laboratory 

reports multiple results for the primary 

(A) urine specimen, the MRO must 

follow the verification procedures 

described in Section 13.5(d) through (f) 

and: 

(1) The MRO reports all verified 

positive and/or refusal to test results to 

the Federal agency. 

(2) If an invalid result was reported in 

conjunction with a positive, adulterated, 

or substituted result, the MRO does not 

report the verified invalid result to the 

Federal agency at this time. The MRO 

takes action for the verified invalid 

result(s) for the primary (A) specimen as 

described in Section 13.5(f) only when: 

(i) The MRO verifies the positive, 

adulterated, or substituted result as 

negative based on a legitimate medical 

explanation as described in Section 

13.5(d)(2) and (e)(1); or 

(ii) The split (B) specimen is tested 

and reported as a failure to reconfirm 

the positive, adulterated, or substituted 

result as described in Section 14.6(m). 

(d) When the HHS-certified laboratory 

reports a positive result for the primary 

(A) specimen, the MRO must contact the 

donor to determine if there is any 

legitimate medical explanation for the 

positive result. 

(1) If the donor admits unauthorized 

use of the drug(s) that caused the 

positive result, the MRO reports the test 

result as positive to the agency. The 

MRO must document the donor’s 

admission of unauthorized drug use in 

the MRO records and in the MRO’s 

report to the Federal agency. 

(2) If the donor provides 

documentation (e.g., a valid 

prescription) to support a legitimate 


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medical explanation for the positive 

result, the MRO reports the test result as 

negative to the agency. If the laboratory 

also reports that the urine specimen is 

dilute, the MRO reports a negative/ 

dilute result to the agency and directs 

the agency to immediately collect 

another specimen from the donor. The 

MRO follows the procedures in Section 

13.5(b)(1) or (2) for the recollected 

specimen. 

(i) Passive exposure to a drug (e.g., 

exposure to marijuana smoke) is not a 

legitimate medical explanation for a 

positive drug test result. 

(ii) Ingestion of food products 

containing a drug (e.g., products 

containing marijuana, poppy seeds 

containing codeine and/or morphine) is 

not a legitimate medical explanation for 

a positive urine drug test result. 

(iii) A physician’s authorization or 

medical recommendation for a Schedule 

1 controlled substance is not a 

legitimate medical explanation for a 

positive drug test result. 

(3) If the donor is unable to provide 

a legitimate medical explanation for the 

positive result, the MRO reports the 

positive result to the agency. If the 

laboratory also reports that the urine 

specimen is dilute, the MRO may 

choose not to report the dilute result. 

(e) When the HHS-certified laboratory 

reports an adulterated or substituted 

result for the primary (A) urine 

specimen, the MRO contacts the donor 

to determine if the donor has a 

legitimate medical explanation for the 

adulterated or substituted result. 

(1) If the donor provides a legitimate 

medical explanation, the MRO reports a 

negative result to the Federal agency. 

(2) If the donor is unable to provide 

a legitimate medical explanation, the 

MRO reports a refusal to test to the 

Federal agency because the urine 

specimen was adulterated or 

substituted. 

(f) When the HHS-certified laboratory 

reports an invalid result for the primary 

(A) urine specimen, the MRO must 

contact the donor to determine if there 

is a legitimate explanation for the 

invalid result. In the case of an invalid 

result based on pH of 9.0 to 9.5, when 

an employee has no other medical 

explanation for the pH in this range, the 

MRO must consider whether there is 

evidence of elapsed time and high 

temperature that could account for the 

pH value. The MRO may contact the 

collection site, HHS-certified IITF, and/ 

or HHS-certified laboratory to discuss 

time and temperature issues (e.g., time 

elapsed from collection to receipt at the 

testing facility, likely temperature 

conditions between the time of the 

collection and transportation to the 

testing facility, specimen storage 

conditions). 

(1) If the donor provides a legitimate 

explanation (e.g., a prescription 

medicine) or if the MRO determines that 

time and temperature account for the 

pH in the 9.0 to 9.5 range, the MRO 

reports a test cancelled result with the 

reason for the invalid result and informs 

the Federal agency that a recollection is 

not required because there is a 

legitimate explanation for the invalid 

result. 

(2) If the donor is unable to provide 

a legitimate explanation or if the MRO 

determines that time and temperature 

fail to account for the pH in the 9.0–9.5 

range, the MRO reports a test cancelled 

result with the reason for the invalid 

result and directs the Federal agency to 

immediately collect another urine 

specimen from the donor using a direct 

observed collection. 

(i) If the specimen collected under 

direct observation provides a valid 

result, the MRO follows the procedures 

in Section 13.5(a) through (e). 

(ii) If the specimen collected under 

direct observation provides an invalid 

result, the MRO reports this specimen as 

test cancelled and recommends that the 

agency collect another authorized 

specimen type (e.g., oral fluid). If the 

Federal agency does not authorize 

collection of another specimen type, the 

MRO consults with the agency to 

arrange a clinical evaluation as 

described in Section 13.7, to determine 

whether there is a legitimate medical 

reason for the invalid result. 

(g) When two separate specimens 

collected during the same testing event 

were sent to the HHS-certified 

laboratory for testing (e.g., the collector 

sent a urine specimen out of 

temperature range and the subsequently 

collected specimen—urine or another 

authorized specimen type), as the MRO, 

you must follow the verification 

procedures described in Sections 13.4, 

13.5, and 13.6, and: 

(1) If both specimens were verified 

negative, report the result as negative. 

(2) If one specimen was verified 

negative and the other was not (i.e., the 

specimen was verified as negative/ 

dilute or as positive, adulterated, 

substituted, and/or invalid), report only 

the verified result(s) other than negative. 

For example, if you verified one 

specimen as negative and the other as a 

refusal to test because the specimen was 

substituted, report only the refusal to 

the Federal agency. 

(3) If both specimens were verified as 

positive, adulterated, and/or 

substituted, report all results. For 

example, if you verified one specimen 

as positive and the other as a refusal to 

test because the specimen was 

adulterated, report the positive and the 

refusal results to the Federal agency. 

(4) If one specimen has been verified 

and the HHS-certified laboratory has not 

reported the result(s) of the other 

specimen, 

(i) Report verified result(s) of positive, 

adulterated, or substituted immediately 

and do not wait to receive the result(s) 

of the other specimen. 

(ii) Do not report a verified result of 

negative, negative/dilute, or invalid for 

the first specimen to the Federal agency. 

Hold the report until results of both 

specimens have been received and 

verified. 

(5) When the HHS-certified laboratory 

reports an invalid result for one or both 

specimens, follow the procedures in 

Section 13.5(c). 

(h) When the HHS-certified laboratory 

or HHS-certified IITF reports a rejected 

for testing result for the primary (A) 

specimen, the MRO reports a test 

cancelled result to the agency and 

recommends that the agency collect 

another specimen from the donor. The 

recollected specimen must be the same 

type (i.e., urine). 

Section 13.6 What action does the 

MRO take when the collector reports 

that the donor did not provide a 

sufficient amount of urine for a drug 

test? 

(a) When another specimen type (e.g., 

oral fluid) was collected in accordance 

with Section 8.6, the MRO reviews and 

reports the test result in accordance 

with the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using the alternate specimen. 

(b) When the Federal agency did not 

authorize the collection of an alternate 

specimen, the MRO consults with the 

Federal agency. The Federal agency 

immediately directs the donor to obtain, 

within five days, an evaluation from a 

licensed physician, acceptable to the 

MRO, who has expertise in the medical 

issues raised by the donor’s failure to 

provide a specimen. The MRO may 

perform this evaluation if the MRO has 

appropriate expertise. 

(1) For purposes of this section, a 

medical condition includes an 

ascertainable physiological condition 

(e.g., a urinary system dysfunction) or a 

medically documented pre-existing 

psychological disorder, but does not 

include unsupported assertions of 

‘‘situational anxiety’’ or dehydration. 

Permanent or long-term medical 

conditions are those physiological, 

anatomic, or psychological 

abnormalities documented as being 

present prior to the attempted 

collection, and considered not amenable 


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to correction or cure for an extended 

period of time. Examples would include 

destruction (any cause) of the 

glomerular filtration system leading to 

renal failure; unrepaired traumatic 

disruption of the urinary tract; or a 

severe psychiatric disorder focused on 

genitourinary matters. Acute or 

temporary medical conditions, such as 

cystitis, urethritis, or prostatitis, though 

they might interfere with collection for 

a limited period of time, cannot receive 

the same exceptional consideration as 

the permanent or long-term conditions 

discussed in the previous sentence. 

(2) As the MRO, if another physician 

will perform the evaluation, you must 

provide the other physician with the 

following information and instructions: 

(i) That the donor was required to take 

a federally regulated drug test, but was 

unable to provide a sufficient amount of 

urine to complete the test; 

(ii) The consequences of the 

appropriate Federal agency regulation 

for refusing to take the required drug 

test; 

(iii) That, after completing the 

evaluation, the referral physician must 

agree to provide a written statement to 

the MRO with a recommendation for 

one of the determinations described in 

Section 13.6(b)(3) and the basis for the 

recommendation. The statement must 

not include detailed information on the 

employee’s medical condition beyond 

what is necessary to explain the referral 

physician’s conclusion. 

(3) As the MRO, if another physician 

performed the evaluation, you must 

consider and assess the referral 

physician’s recommendations in making 

your determination. You must make one 

of the following determinations and 

report it to the Federal agency in 

writing: 

(i) A medical condition as defined in 

Section 13.6(b)(1) has, or with a high 

degree of probability could have, 

precluded the employee from providing 

a sufficient amount of urine, but is not 

a permanent or long-term disability. As 

the MRO, you must report a test 

cancelled result to the Federal agency. 

(ii) A permanent or long-term medical 

condition as defined in Section 

13.6(b)(1) has, or with a high degree of 

probability could have, precluded the 

employee from providing a sufficient 

amount of urine and is highly likely to 

prevent the employee from providing a 

sufficient amount of urine for a very 

long or indefinite period of time. As the 

MRO, you must follow the requirements 

of Section 13.7, as appropriate. If 

Section 13.7 is not applicable, you 

report a test cancelled result to the 

Federal agency and recommend that the 

agency authorize collection of an 

alternate specimen type (e.g., oral fluid) 

for any subsequent drug tests for the 

donor. 

(iii) There is not an adequate basis for 

determining that a medical condition 

has, or with a high degree of probability 

could have, precluded the employee 

from providing a sufficient amount of 

urine. As the MRO, you must report a 

refusal to test to the Federal agency. 

(4) When a Federal agency receives a 

report from the MRO indicating that a 

test is cancelled as provided in Section 

13.6(b)(3)(i), the agency takes no further 

action with respect to the donor. When 

a test is canceled as provided in Section 

13.6(b)(3)(ii), the agency takes no further 

action with respect to the donor other 

than designating collection of an 

alternate specimen type (i.e., authorized 

by the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs) for 

any subsequent collections, in 

accordance with the Federal agency 

plan. The donor remains in the random 

testing pool. 

Section 13.7 What happens when an 

individual is unable to provide a 

sufficient amount of urine for a Federal 

agency applicant/pre-employment test, 

a follow-up test, or a return-to-duty test 

because of a permanent or long-term 

medical condition? 

(a) This section concerns a situation 

in which the donor has a medical 

condition that precludes the donor from 

providing a sufficient specimen for a 

Federal agency applicant/preemployment test, a follow-up test, or a 

return-to-duty test and the condition 

involves a permanent or long-term 

disability and the Federal agency does 

not authorize collection of an alternate 

specimen. As the MRO in this situation, 

you must do the following: 

(1) You must determine if there is 

clinical evidence that the individual is 

an illicit drug user. You must make this 

determination by personally 

conducting, or causing to be conducted, 

a medical evaluation and through 

consultation with the donor’s physician 

and/or the physician who conducted the 

evaluation under Section 13.6. 

(2) If you do not personally conduct 

the medical evaluation, you must ensure 

that one is conducted by a licensed 

physician acceptable to you. 

(b) If the medical evaluation reveals 

no clinical evidence of illicit drug use, 

as the MRO, you must report the result 

to the Federal agency as a negative test 

with written notations regarding results 

of both the evaluation conducted under 

Section 13.6 and any further medical 

examination. This report must state the 

basis for the determination that a 

permanent or long-term medical 

condition exists, making provision of a 

sufficient urine specimen impossible, 

and for the determination that no signs 

and symptoms of drug use exist. The 

MRO recommends that the agency 

authorize collection of an alternate 

specimen type (e.g., oral fluid) for any 

subsequent collections. 

(c) If the medical evaluation reveals 

clinical evidence of drug use, as the 

MRO, you must report the result to the 

Federal agency as a cancelled test with 

written notations regarding results of 

both the evaluation conducted under 

Section 13.6 and any further medical 

examination. This report must state that 

a permanent or long-term medical 

condition [as defined in Section 

13.6(b)(1)] exists, making provision of a 

sufficient urine specimen impossible, 

and state the reason for the 

determination that signs and symptoms 

of drug use exist. Because this is a 

cancelled test, it does not serve the 

purposes of a negative test (e.g., the 

Federal agency is not authorized to 

allow the donor to begin or resume 

performing official functions, because a 

negative test is needed for that purpose). 

Section 13.8 How does an MRO report 

a primary (A) specimen test result to an 

agency? 

(a) The MRO must report all verified 

results to an agency using the completed 

MRO copy of the Federal CCF or a 

separate report using a letter/ 

memorandum format. The MRO may 

use various electronic means for 

reporting (e.g., fax, computer). 

Transmissions of the reports must 

ensure confidentiality. The MRO and 

external service providers must ensure 

the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(b) A verified result may not be 

reported to the agency until the MRO 

has completed the review process. 

(c) The MRO must send a copy of 

either the completed MRO copy of the 

Federal CCF or the separate letter/ 

memorandum report for all positive, 

adulterated, and substituted results. 

(d) The MRO must not disclose 

numerical values of drug test results to 

the agency. 

(e) The MRO must report drug test 

results using the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels. 

Section 13.9 Who may request a test of 

a split (B) specimen? 

(a) For a positive, adulterated, or 

substituted result reported on a primary 

(A) specimen, a donor may request 

through the MRO that the split (B) 


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specimen be tested by a second HHScertified laboratory to verify the result 

reported by the first HHS-certified 

laboratory. 

(b) The donor has 72 hours (from the 

time the MRO notified the donor that 

the donor’s specimen was reported 

positive, adulterated, or substituted to 

request a test of the split (B) specimen. 

The MRO must inform the donor that 

the donor has the opportunity to request 

a test of the split (B) specimen when the 

MRO informs the donor that a positive, 

adulterated, or substituted result is 

being reported to the Federal agency on 

the primary (A) specimen. 

Section 13.10 What types of 

relationships are prohibited between an 

MRO and an HHS-certified laboratory or 

an HHS-certified IITF? 

An MRO must not be an employee, 

agent of, or have any financial interest 

in an HHS-certified laboratory or an 

HHS-certified IITF for which the MRO 

is reviewing drug test results. 

This means an MRO must not derive 

any financial benefit by having an 

agency use a specific HHS-certified 

laboratory or HHS-certified IITF, or have 

any agreement with the HHS-certified 

laboratory or the HHS-certified IITF that 

may be construed as a potential conflict 

of interest. 

Section 13.11 What reports must an 

MRO provide to the Secretary for urine 

testing? 

(a) An MRO must send to the 

Secretary or designated HHS 

representative a semiannual report of 

Federal agency specimens that were 

reported as positive for a drug or drug 

metabolite by a laboratory and verified 

as negative by the MRO. The report 

must not include any personally 

identifiable information for the donor 

and must be submitted by mail, fax, or 

other secure electronic transmission 

method within 14 working days after 

the end of the semiannual period (i.e., 

in January and July). The semiannual 

report must contain the following 

information: 

(1) Reporting period (inclusive dates); 

(2) MRO name, company name, and 

address; 

(3) Federal agency name; and 

(4) For each laboratory-reported 

positive drug test result that was 

verified as negative by the MRO: 

(i) Specimen identification number; 

(ii) Laboratory name and address; 

(iii) Positive drug(s) or drug 

metabolite(s) verified as negative; 

(iv) MRO reason for verifying the 

positive drug(s) or drug metabolite(s) as 

negative (e.g., a donor prescription [the 

MRO must specify the prescribed drug]); 

(v) All results reported to the Federal 

agency by the MRO for the specimen; 

and 

(vi) Date of the MRO report to the 

Federal agency. 

(b) An MRO must provide copies of 

the drug test reports that the MRO has 

sent to a Federal agency when requested 

to do so by the Secretary. 

(c) If an MRO did not verify any 

positive laboratory results as negative 

during the reporting period, the MRO 

should file a report that states that the 

MRO has no reportable results during 

the applicable reporting period. 

Section 13.12 What are a Federal 

agency’s responsibilities for designating 

an MRO? 

(a) Before allowing an individual to 

serve as an MRO for the agency, a 

Federal agency must verify and 

document the following: 

(1) that the individual satisfies all 

requirements in Section 13.1, including 

certification by an MRO certification 

organization that has been approved by 

the Secretary, as described in Section 

13.2; and 

(2) that the individual is not an 

employee, agent of, or have any 

financial interest in an HHS-certified 

laboratory or an HHS-certified IITF that 

tests the agency’s specimens, as 

described in Section 13.10. 

(b) The Federal agency must verify 

and document that each MRO reviewing 

and reporting results for the agency: 

(1) completes training on any 

revisions to these Guidelines, including 

any changes to the drug and biomarker 

testing panels, prior to their effective 

date; 

(2) at least every five years, maintains 

their certification by completing 

requalification training and passing a 

requalification examination; and 

(3) provides biannual reports to the 

Secretary or designated HHS 

representative as required in Section 

13.11; 

(c) The Federal agency must ensure 

that each MRO reports drug test results 

to the agency in accordance with 

Sections 13.8 and 14.7. 

(1) Before allowing an MRO to report 

results electronically, the agency must 

obtain documentation from the MRO to 

confirm that the MRO and any external 

service providers ensure the 

confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

Subpart N—Split Specimen Tests 

Section 14.1 When may a split (B) 

urine specimen be tested? 

(a) The donor may request, verbally or 

in writing, through the MRO that the 

split (B) urine specimen be tested at a 

different (i.e., second) HHS-certified 

laboratory when the primary (A) 

specimen was determined by the MRO 

to be positive, adulterated, or 

substituted. 

(b) A donor has 72 hours to initiate 

the request after being informed of the 

result by the MRO. The MRO must 

document in the MRO’s records the 

verbal request from the donor to have 

the split (B) specimen tested. 

(c) If a split (B) urine specimen cannot 

be tested by a second HHS-certified 

laboratory (e.g., insufficient specimen, 

lost in transit, split not available, no 

second HHS-certified laboratory to 

perform the test), the MRO reports a 

cancelled test to the Federal agency and 

the reason for the cancellation. The 

MRO directs the Federal agency to 

ensure the immediate recollection of 

another urine specimen from the donor 

under direct observation, with no notice 

given to the donor of this collection 

requirement until immediately before 

the collection. 

(d) If a donor chooses not to have the 

split (B) specimen tested by a second 

HHS-certified laboratory, a Federal 

agency may have a split (B) specimen 

retested as part of a legal or 

administrative proceeding to defend an 

original positive, adulterated, or 

substituted result. 

Section 14.2 How does an HHScertified laboratory test a split (B) 

specimen when the primary (A) 

specimen was reported positive? 

(a) The testing of a split (B) specimen 

for a drug or metabolite is not subject to 

the testing cutoffs established. 

(b) The HHS-certified laboratory is 

only required to confirm the presence of 

the drug or metabolite that was reported 

positive in the primary (A) specimen. 

(c) For a split (B) urine specimen, if 

the second HHS-certified laboratory 

fails to reconfirm the presence of the 

drug or drug metabolite that was 

reported by the first HHS-certified 

laboratory, the second laboratory must 

conduct specimen validity tests in an 

attempt to determine the reason for 

being unable to reconfirm the presence 

of the drug or drug metabolite. The 

second laboratory should conduct the 

same specimen validity tests as it would 

conduct on a primary (A) urine 

specimen and reports those results to 

the MRO. 


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Section 14.3 How does an HHScertified laboratory test a split (B) urine 

specimen when the primary (A) 

specimen was reported adulterated? 

(a) An HHS-certified laboratory must 

use one of the following criteria to 

reconfirm an adulterated result when 

testing a split (B) urine specimen: 

(1) pH must be measured using the 

laboratory’s confirmatory pH test with 

the appropriate cutoff (i.e., either less 

than 4 or equal to or greater than 11); 

(2) Nitrite must be measured using the 

laboratory’s confirmatory nitrite test 

with a cutoff of equal to or greater than 

500 mcg/mL; 

(3) Surfactant must be measured using 

the laboratory’s confirmatory surfactant 

test with a cutoff of equal to or greater 

than 100 mcg/mL dodecylbenzene 

sulfonate-equivalent cutoff; or 

(4) For adulterants without a specified 

cutoff (e.g., glutaraldehyde, chromium 

(VI), pyridine, halogens (such as, 

chlorine from bleach, iodine), 

peroxidase, peroxide, other oxidizing 

agents), the laboratory must use its 

confirmatory specimen validity test at 

an established LOQ to reconfirm the 

presence of the adulterant. 

(b) The second HHS-certified 

laboratory may only conduct the 

confirmatory specimen validity test(s) 

needed to reconfirm the adulterated 

result reported by the first HHS-certified 

laboratory. 

Section 14.4 How does an HHScertified laboratory test a split (B) urine 

specimen when the primary (A) 

specimen was reported substituted? 

(a) An HHS-certified laboratory must 

use the following criteria to reconfirm a 

substituted result when testing a split 

(B) urine specimen: 

(1) For substitution based on 

creatinine and specific gravity testing: 

The creatinine must be measured using 

the laboratory’s confirmatory creatinine 

test with a cutoff of less than 2 mg/dL, 

and the specific gravity must be 

measured using the laboratory’s 

confirmatory specific gravity test with 

the specified cutoffs of less than or 

equal to 1.0010 or equal to or greater 

than 1.0200. 

(2) For substitution based on 

biomarker testing: The laboratory must 

test for the biomarker using its 

confirmatory test (i.e., using the 

confirmatory test analytes and cutoffs in 

the biomarker testing panel). 

(b) The second HHS-certified 

laboratory may only conduct the 

confirmatory specimen validity test(s) 

needed to reconfirm the substituted 

result reported by the first HHS-certified 

laboratory. 

Section 14.5 Who receives the split (B) 

specimen result? 

The second HHS-certified laboratory 

must report the result to the MRO using 

the HHS-specified nomenclature 

published with the drug and biomarker 

testing panels. 

Section 14.6 What action(s) does an 

MRO take after receiving the split (B) 

urine specimen result from the second 

HHS-certified laboratory? 

The MRO takes the following actions 

when the second HHS-certified 

laboratory reports the result for the split 

(B) urine specimen as: 

(a) Reconfirmed the drug(s), 

adulteration, and/or substitution result. 

The MRO reports reconfirmed to the 

agency. 

(b) Failed to reconfirm a single or all 

drug positive results and the specimen 

was adulterated. If the donor provides a 

legitimate medical explanation for the 

adulteration result, the MRO reports a 

failed to reconfirm result (specifying the 

drug[s]) and cancels both tests. If there 

is no legitimate medical explanation, 

the MRO reports a failed to reconfirm 

result (specifying the drug[s]) and a 

refusal to test to the agency and 

indicates the adulterant that is present 

in the specimen. The MRO gives the 

donor 72 hours to request that 

Laboratory A retest the primary (A) 

specimen for the adulterant. If 

Laboratory A reconfirms the adulterant, 

the MRO reports refusal to test and 

indicates the adulterant present. If 

Laboratory A fails to reconfirm the 

adulterant, the MRO cancels both tests 

and directs the agency to immediately 

collect another specimen using a direct 

observed collection procedure. The 

MRO shall notify the appropriate 

regulatory office about the failed to 

reconfirm and cancelled test. 

(c) Failed to reconfirm a single or all 

drug positive results and the specimen 

was substituted. If the donor provides a 

legitimate medical explanation for the 

substituted result, the MRO reports a 

failed to reconfirm result (specifying the 

drug[s]) and cancels both tests. If there 

is no legitimate medical explanation, 

the MRO reports a failed to reconfirm 

result (specifying the drug[s]) and a 

refusal to test (substituted) to the 

agency. The MRO gives the donor 72 

hours to request additional review or 

testing as follows: 

(1) For substitution based on 

creatinine and specific gravity: request 

that Laboratory A review the creatinine 

and specific gravity results for the 

primary (A) specimen. 

(2) For substitution based on 

biomarker testing: request that 

Laboratory A test the primary (A) 

specimen using its confirmatory test for 

the biomarker. 

(i) If the primary (A) specimen’s test 

results confirm that the specimen was 

substituted, the MRO reports a refusal to 

test (substituted) to the agency. 

(ii) If the primary (A) specimen’s 

results fail to confirm that the specimen 

was substituted, the MRO cancels both 

tests and directs the agency to 

immediately collect another specimen 

using a direct observed collection 

procedure. The MRO shall notify the 

HHS office responsible for coordination 

of the drug-free workplace program 

about the failed to reconfirm and 

cancelled test. 

(d) Failed to reconfirm a single or all 

drug positive results and the specimen 

was not adulterated or substituted. The 

MRO reports to the agency a failed to 

reconfirm result (specifying the drug[s]), 

cancels both tests, and notifies the HHS 

office responsible for coordination of 

the drug-free workplace program. 

(e) Failed to reconfirm a single or all 

drug positive results and the specimen 

had an invalid result. The MRO reports 

to the agency a failed to reconfirm result 

(specifying the drug[s] and the reason 

for the invalid result), cancels both tests, 

directs the agency to immediately 

collect another specimen using a direct 

observed collection procedure, and 

notifies the HHS office responsible for 

coordination of the drug-free workplace 

program. 

(f) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and the specimen was adulterated. The 

MRO reports to the agency a 

reconfirmed result (specifying the 

drug[s]) and a failed to reconfirm result 

(specifying the drug[s]). The MRO tells 

the agency that it may take action based 

on the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and found that the specimen 

was adulterated. The MRO shall notify 

the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(g) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and the specimen was substituted. The 

MRO reports to the agency a 

reconfirmed result (specifying the 

drug[s]) and a failed to reconfirm result 

(specifying the drug[s]). The MRO tells 

the agency that it may take action based 

on the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and found that the specimen 

was substituted. The MRO shall notify 

the HHS office responsible for 

coordination of the drug-free workplace 


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program regarding the test results for the 

specimen. 

(h) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and the specimen was not adulterated 

or substituted. The MRO reports to the 

agency a reconfirmed result (specifying 

the drug[s]) and a failed to reconfirm 

result (specifying the drug[s]). The MRO 

tells the agency that it may take action 

based on the reconfirmed drug(s) 

although Laboratory B failed to 

reconfirm one or more drugs. The MRO 

shall notify the HHS office responsible 

for coordination of the drug-free 

workplace program regarding the test 

results for the specimen. 

(i) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and the specimen had an invalid result. 

The MRO reports to the agency a 

reconfirmed result (specifying the 

drug[s]) and a failed to reconfirm result 

(specifying the drug[s]). The MRO tells 

the agency that it may take action based 

on the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and reported an invalid 

result. The MRO shall notify the HHS 

office responsible for coordination of 

the drug-free workplace program 

regarding the test results for the 

specimen. 

(j) Failed to reconfirm substitution or 

adulteration. The MRO reports to the 

agency a failed to reconfirm result (not 

adulterated: specifying the adulterant/ 

pH or not substituted) and cancels both 

tests. The MRO shall notify the HHS 

office responsible for coordination of 

the drug-free workplace program 

regarding the test results for the 

specimen. 

(k) Failed to reconfirm substitution or 

adulteration and the specimen had an 

invalid result. The MRO reports to the 

agency a failed to reconfirm result (not 

adulterated: specifying the adulterant/ 

pH or not substituted, and the reason for 

the invalid result), cancels both tests, 

directs the agency to immediately 

collect another specimen using a direct 

observed collection procedure and 

notifies the HHS office responsible for 

coordination of the drug-free workplace 

program. 

(l) Failed to reconfirm a single or all 

drug positive results and reconfirmed an 

adulterated or substituted result. The 

MRO reports to the agency a 

reconfirmed result (adulterated or 

substituted) and a failed to reconfirm 

result (specifying the drug[s]). The MRO 

tells the agency that it may take action 

based on the reconfirmed result 

(adulterated or substituted) although 

Laboratory B failed to reconfirm the 

drug(s) result. 

(m) Failed to reconfirm a single or all 

drug positive results and failed to 

reconfirm the adulterated or substituted 

result. The MRO reports to the agency 

a failed to reconfirm result (specifying 

the drug[s] and not adulterated: 

specifying the adulterant/pH or not 

substituted) and cancels both tests. The 

MRO shall notify the HHS office 

responsible for coordination of the drugfree workplace program regarding the 

test results for the specimen. 

(n) Failed to reconfirm at least one 

drug and reconfirmed the adulterated 

result. The MRO reports to the agency 

a reconfirmed result (specifying the 

drug[s] and adulterated) and a failed to 

reconfirm result (specifying the drug[s]). 

The MRO tells the agency that it may 

take action based on the reconfirmed 

drug(s) and the adulterated result 

although Laboratory B failed to 

reconfirm one or more drugs. 

(o) Failed to reconfirm at least one 

drug and failed to reconfirm the 

adulterated result. The MRO reports to 

the agency a reconfirmed result 

(specifying the drug[s]) and a failed to 

reconfirm result (specifying the drug[s] 

and not adulterated: specifying the 

adulterant/pH). The MRO tells the 

agency that it may take action based on 

the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and failed to reconfirm the 

adulterated result. 

(p) Failed to reconfirm an adulterated 

result and failed to reconfirm a 

substituted result. The MRO reports to 

the agency a failed to reconfirm result 

(not adulterated: specifying the 

adulterant/pH, and not substituted) and 

cancels both tests. The MRO shall notify 

the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(q) Failed to reconfirm an adulterated 

result and reconfirmed a substituted 

result. The MRO reports to the agency 

a reconfirmed result (substituted) and a 

failed to reconfirm result (not 

adulterated: specifying the adulterant/ 

pH). The MRO tells the agency that it 

may take action based on the substituted 

result although Laboratory B failed to 

reconfirm the adulterated result. 

(r) Failed to reconfirm a substituted 

result and reconfirmed an adulterated 

result. The MRO reports to the agency 

a reconfirmed result (adulterated) and a 

failed to reconfirm result (not 

substituted). The MRO tells the agency 

that it may take action based on the 

adulterated result although Laboratory B 

failed to reconfirm the substituted 

result. 

Section 14.7 How does an MRO report 

a split (B) specimen test result to an 

agency? 

(a) The MRO must report all verified 

results to an agency using the completed 

MRO copy of the Federal CCF or a 

separate report using a letter/ 

memorandum format. The MRO may 

use various electronic means for 

reporting (e.g., fax, computer). 

Transmissions of the reports must 

ensure confidentiality. The MRO and 

external service providers must ensure 

the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(b) A verified result may not be 

reported to the agency until the MRO 

has completed the review process. 

(c) The MRO must send a copy of 

either the completed MRO copy of the 

Federal CCF or the separate letter/ 

memorandum report for all split 

specimen results. 

(d) The MRO must not disclose the 

numerical values of the drug test results 

to the agency. 

(e) The MRO must report drug test 

results using the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels. 

Section 14.8 How long must an HHScertified laboratory retain a split (B) 

specimen? 

A split (B) specimen is retained for 

the same period of time that a primary 

(A) specimen is retained and under the 

same storage conditions, in accordance 

with Section 11.20. This applies even 

for those cases when the split (B) 

specimen is tested by a second HHScertified laboratory and the second 

HHS-certified laboratory does not 

confirm the original result reported by 

the first HHS-certified laboratory for the 

primary (A) specimen. 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

Section 15.1 What discrepancies 

require an HHS-certified laboratory or 

an HHS-certified IITF to report a urine 

specimen as rejected for testing? 

The following discrepancies are 

considered to be fatal flaws. The HHScertified laboratory or IITF must stop 

the testing process, reject the specimen 

for testing, and indicate the reason for 

rejecting the specimen on the Federal 

CCF when: 

(a) The specimen ID number on the 

primary (A) or split (B) specimen label/ 

seal does not match the ID number on 

the Federal CCF, or the ID number is 

missing either on the Federal CCF or on 

either specimen label/seal; 


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(b) The primary (A) specimen label/ 

seal is missing, misapplied, broken, or 

shows evidence of tampering and the 

split (B) specimen cannot be redesignated as the primary (A) specimen; 

(c) The collector’s printed name and 

signature are omitted on the Federal 

CCF; 

(d) There is an insufficient amount of 

specimen for analysis in the primary (A) 

specimen and the split (B) specimen 

cannot be re-designated as the primary 

(A) specimen; 

(e) The accessioner failed to 

document the primary (A) specimen 

seal condition on the Federal CCF at the 

time of accessioning, and the split (B) 

specimen cannot be re-designated as the 

primary (A) specimen; 

(f) The specimen was received at the 

HHS-certified laboratory or IITF without 

a CCF; 

(g) The CCF was received at the HHScertified laboratory or IITF without a 

specimen; 

(h) The collector performed two 

separate collections using one CCF; or 

(i) The HHS-certified laboratory or 

IITF identifies a flaw (other than those 

specified above) that prevents testing or 

affects the forensic defensibility of the 

drug test and cannot be corrected. 

Section 15.2 What discrepancies 

require an HHS-certified laboratory or 

an HHS-certified IITF to report a 

specimen as rejected for testing unless 

the discrepancy is corrected? 

The following discrepancies are 

considered to be correctable: 

(a) If a collector failed to sign the 

Federal CCF, the HHS-certified 

laboratory or IITF must hold the 

specimen and attempt to obtain a 

memorandum for record to recover the 

collector’s signature. If, after holding the 

specimen for at least 5 business days, 

the HHS-certified laboratory or IITF 

cannot recover the collector’s signature, 

the laboratory or IITF must report a 

rejected for testing result and indicate 

the reason for the rejected for testing 

result on the Federal CCF. 

(b) If a specimen is submitted using a 

non-Federal form or an expired Federal 

CCF, the HHS-certified laboratory or 

IITF must test the specimen and also 

attempt to obtain a memorandum for 

record explaining why a non-Federal 

form or an expired Federal CCF was 

used and ensure that the form used 

contains all the required information. If, 

after holding the report for at least 5 

business days, the HHS-certified 

laboratory or IITF cannot obtain a 

memorandum for record from the 

collector, the laboratory or IITF must 

report a rejected for testing result and 

indicate the reason for the rejected for 

testing result on the report to the MRO. 

Section 15.3 What discrepancies are 

not sufficient to require an HHScertified laboratory or an HHS-certified 

IITF to reject a urine specimen for 

testing or an MRO to cancel a test? 

(a) The following omissions and 

discrepancies on the Federal CCF that 

are received by the HHS-certified 

laboratory or IITF should not cause an 

HHS-certified laboratory or IITF to reject 

a urine specimen or cause an MRO to 

cancel a test: 

(1) An incorrect laboratory name and 

address appearing at the top of the form; 

(2) Incomplete/incorrect/unreadable 

employer name or address; 

(3) MRO name is missing; 

(4) Incomplete/incorrect MRO 

address; 

(5) A transposition of numbers in the 

donor’s Social Security Number or 

employee identification number; 

(6) A telephone number is missing/ 

incorrect; 

(7) A fax number is missing/incorrect; 

(8) A ‘‘reason for test’’ box is not 

marked; 

(9) A ‘‘drug tests to be performed’’ box 

is not marked; 

(10) A ‘‘collection’’ box is not marked; 

(11) The ‘‘observed’’ box is not 

marked (if applicable); 

(12) The collection site address is 

missing; 

(13) The collector’s printed name is 

missing but the collector’s signature is 

properly recorded; 

(14) The time of collection is not 

indicated; 

(15) The date of collection is not 

indicated; 

(16) Incorrect name of delivery 

service; 

(17) The collector has changed or 

corrected information by crossing out 

the original information on either the 

Federal CCF or specimen label/seal 

without dating and initialing the 

change; or 

(18) The donor’s name inadvertently 

appears on the HHS-certified laboratory 

or IITF copy of the Federal CCF or on 

the tamper-evident labels used to seal 

the specimens. 

(19) The collector failed to check the 

specimen temperature box and the 

‘‘Remarks’’ line did not have a comment 

regarding the temperature being out of 

range. If, after at least 5 business days, 

the collector cannot provide a 

memorandum for record to attest to the 

fact that the collector did measure the 

specimen temperature, the HHScertified laboratory or IITF may report 

the test result for the specimen but 

indicates that the collector could not 

provide a memorandum to recover the 

omission. 

(b) The following omissions and 

discrepancies on the Federal CCF that 

are made at the HHS-certified laboratory 

or IITF should not cause an MRO to 

cancel a test: 

(1) The testing laboratory or IITF fails 

to indicate the correct name and address 

in the results section when a different 

laboratory or IITF name and address is 

printed at the top of the Federal CCF; 

(2) The accessioner fails to print their 

name; 

(3) The certifying scientist or 

certifying technician fails to print their 

name; 

(4) The certifying scientist or 

certifying technician accidentally 

initials the Federal CCF rather than 

signing for a specimen reported as 

rejected for testing; 

(c) The above omissions and 

discrepancies should occur no more 

than once a month. The expectation is 

that each trained collector and HHScertified laboratory or IITF will make 

every effort to ensure that the Federal 

CCF is properly completed and that all 

the information is correct. When an 

error occurs more than once a month, 

the MRO must direct the collector, HHScertified laboratory, or HHS-certified 

IITF (whichever is responsible for the 

error) to immediately take corrective 

action to prevent the recurrence of the 

error. 

Section 15.4 What discrepancies may 

require an MRO to cancel a test? 

(a) An MRO must attempt to correct 

the following errors: 

(1) The donor’s signature is missing 

on the MRO copy of the Federal CCF 

and the collector failed to provide a 

comment that the donor refused to sign 

the form; 

(2) The certifying scientist failed to 

sign the Federal CCF for a specimen 

being reported drug positive, 

adulterated, invalid, or substituted; or 

(3) The electronic report provided by 

the HHS-certified laboratory or HHScertified IITF does not contain all the 

data elements required for the HHS 

standard laboratory or IITF electronic 

report for a specimen being reported 

drug positive, adulterated, invalid 

result, or substituted. 

(b) If the error in Section 15.4(a)(1) 

occurs, the MRO must contact the 

collector to obtain a statement to verify 

that the donor refused to sign the MRO 

copy. If, after at least 5 business days, 

the collector cannot provide such a 

statement, the MRO must cancel the 

test. 

(c) If the error in Section 15.4(a)(2) 

occurs, the MRO must obtain a 


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statement from the certifying scientist 

that they forgot to sign the Federal CCF, 

but did, in fact, properly conduct the 

certification review. If, after at least 5 

business days, the MRO cannot get a 

statement from the certifying scientist, 

the MRO must cancel the test. 

(d) If the error in Section 15.4(a)(3) 

occurs, the MRO must contact the HHScertified laboratory or HHS-certified 

IITF. If, after at least 5 business days, 

the laboratory or IITF does not 

retransmit a corrected electronic report, 

the MRO must cancel the test. 

Subpart P—Laboratory or IITF 

Suspension/Revocation Procedures 

Section 16.1 When may the HHS 

certification of a laboratory or IITF be 

suspended? 

These procedures apply when: 

(a) The Secretary has notified an HHScertified laboratory or IITF in writing 

that its certification to perform drug 

testing under these Guidelines has been 

suspended or that the Secretary 

proposes to revoke such certification. 

(b) The HHS-certified laboratory or 

IITF has, within 30 days of the date of 

such notification or within 3 days of the 

date of such notification when seeking 

an expedited review of a suspension, 

requested in writing an opportunity for 

an informal review of the suspension or 

proposed revocation. 

Section 16.2 What definitions are used 

for this subpart? 

Appellant. Means the HHS-certified 

laboratory or IITF which has been 

notified of its suspension or proposed 

revocation of its certification to perform 

testing and has requested an informal 

review thereof. 

Respondent. Means the person or 

persons designated by the Secretary in 

implementing these Guidelines. 

Reviewing Official. Means the person 

or persons designated by the Secretary 

who will review the suspension or 

proposed revocation. The reviewing 

official may be assisted by one or more 

of the official’s employees or 

consultants in assessing and weighing 

the scientific and technical evidence 

and other information submitted by the 

appellant and respondent on the reasons 

for the suspension and proposed 

revocation. 

Section 16.3 Are there any limitations 

on issues subject to review? 

The scope of review shall be limited 

to the facts relevant to any suspension 

or proposed revocation, the necessary 

interpretations of those facts, the 

relevant Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs, and other relevant law. The 

legal validity of these Guidelines shall 

not be subject to review under these 

procedures. 

Section 16.4 Who represents the 

parties? 

The appellant’s request for review 

shall specify the name, address, and 

telephone number of the appellant’s 

representative. In its first written 

submission to the reviewing official, the 

respondent shall specify the name, 

address, and telephone number of the 

respondent’s representative. 

Section 16.5 When must a request for 

informal review be submitted? 

(a) Within 30 days of the date of the 

notice of the suspension or proposed 

revocation, the appellant must submit a 

written request to the reviewing official 

seeking review, unless some other time 

period is agreed to by the parties. A 

copy must also be sent to the 

respondent. The request for review must 

include a copy of the notice of 

suspension or proposed revocation, a 

brief statement of why the decision to 

suspend or propose revocation is wrong, 

and the appellant’s request for an oral 

presentation, if desired. 

(b) Within 5 days after receiving the 

request for review, the reviewing official 

will send an acknowledgment and 

advise the appellant of the next steps. 

The reviewing official will also send a 

copy of the acknowledgment to the 

respondent. 

Section 16.6 What is an abeyance 

agreement? 

Upon mutual agreement of the parties 

to hold these procedures in abeyance, 

the reviewing official will stay these 

procedures for a reasonable time while 

the laboratory or IITF attempts to regain 

compliance with the Guidelines or the 

parties otherwise attempt to settle the 

dispute. As part of an abeyance 

agreement, the parties can agree to 

extend the time period for requesting 

review of the suspension or proposed 

revocation. If abeyance begins after a 

request for review has been filed, the 

appellant shall notify the reviewing 

official at the end of the abeyance 

period, advising whether the dispute 

has been resolved. If the dispute has 

been resolved, the request for review 

will be dismissed. If the dispute has not 

been resolved, the review procedures 

will begin at the point at which they 

were interrupted by the abeyance 

agreement with such modifications to 

the procedures as the reviewing official 

deems appropriate. 

Section 16.7 What procedures are used 

to prepare the review file and written 

argument? 

The appellant and the respondent 

each participate in developing the file 

for the reviewing official and in 

submitting written arguments. The 

procedures for development of the 

review file and submission of written 

argument are: 

(a) Appellant’s Documents and Brief. 

Within 15 days after receiving the 

acknowledgment of the request for 

review, the appellant shall submit to the 

reviewing official the following (with a 

copy to the respondent): 

(1) A review file containing the 

documents supporting appellant’s 

argument, tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining why 

respondent’s decision to suspend or 

propose revocation of appellant’s 

certification is wrong (appellant’s brief). 

(b) Respondent’s Documents and 

Brief. Within 15 days after receiving a 

copy of the acknowledgment of the 

request for review, the respondent shall 

submit to the reviewing official the 

following (with a copy to the appellant): 

(1) A review file containing 

documents supporting respondent’s 

decision to suspend or revoke 

appellant’s certification to perform drug 

testing, which is tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not exceeding 

20 double-spaced pages in length, 

explaining the basis for suspension or 

proposed revocation (respondent’s 

brief). 

(c) Reply Briefs. Within 5 days after 

receiving the opposing party’s 

submission, or 20 days after receiving 

acknowledgment of the request for 

review, whichever is later, each party 

may submit a short reply not to exceed 

10 double-spaced pages. 

(d) Cooperative Efforts. Whenever 

feasible, the parties should attempt to 

develop a joint review file. 

(e) Excessive Documentation. The 

reviewing official may take any 

appropriate step to reduce excessive 

documentation, including the return of 

or refusal to consider documentation 

found to be irrelevant, redundant, or 

unnecessary. 


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Section 16.8 When is there an 

opportunity for oral presentation? 

(a) Electing Oral Presentation. If an 

opportunity for an oral presentation is 

desired, the appellant shall request it at 

the time it submits its written request 

for review to the reviewing official. The 

reviewing official will grant the request 

if the official determines that the 

decision-making process will be 

substantially aided by oral presentations 

and arguments. The reviewing official 

may also provide for an oral 

presentation at the official’s own 

initiative or at the request of the 

respondent. 

(b) Presiding Official. The reviewing 

official or designee will be the presiding 

official responsible for conducting the 

oral presentation. 

(c) Preliminary Conference. The 

presiding official may hold a prehearing 

conference (usually a telephone 

conference call) to consider any of the 

following: simplifying and clarifying 

issues, stipulations and admissions, 

limitations on evidence and witnesses 

that will be presented at the hearing, 

time allotted for each witness and the 

hearing altogether, scheduling the 

hearing, and any other matter that will 

assist in the review process. Normally, 

this conference will be conducted 

informally and off the record; however, 

the presiding official may, at their 

discretion, produce a written document 

summarizing the conference or 

transcribe the conference, either of 

which will be made a part of the record. 

(d) Time and Place of the Oral 

Presentation. The presiding official will 

attempt to schedule the oral 

presentation within 30 days of the date 

the appellant’s request for review is 

received or within 10 days of 

submission of the last reply brief, 

whichever is later. The oral presentation 

will be held at a time and place 

determined by the presiding official 

following consultation with the parties. 

(e) Conduct of the Oral Presentation. 

(1) General. The presiding official is 

responsible for conducting the oral 

presentation. The presiding official may 

be assisted by one or more of the 

official’s employees or consultants in 

conducting the oral presentation and 

reviewing the evidence. While the oral 

presentation will be kept as informal as 

possible, the presiding official may take 

all necessary steps to ensure an orderly 

proceeding. 

(2) Burden of Proof/Standard of Proof. 

In all cases, the respondent bears the 

burden of proving by a preponderance 

of the evidence that its decision to 

suspend or propose revocation is 

appropriate. The appellant, however, 

has a responsibility to respond to the 

respondent’s allegations with evidence 

and argument to show that the 

respondent is wrong. 

(3) Admission of Evidence. The 

Federal Rules of Evidence do not apply 

and the presiding official will generally 

admit all testimonial evidence unless it 

is clearly irrelevant, immaterial, or 

unduly repetitious. Each party may 

make an opening and closing statement, 

may present witnesses as agreed upon 

in the prehearing conference or 

otherwise, and may question the 

opposing party’s witnesses. Since the 

parties have ample opportunity to 

prepare the review file, a party may 

introduce additional documentation 

during the oral presentation only with 

the permission of the presiding official. 

The presiding official may question 

witnesses directly and take such other 

steps necessary to ensure an effective 

and efficient consideration of the 

evidence, including setting time 

limitations on direct and crossexaminations. 

(4) Motions. The presiding official 

may rule on motions including, for 

example, motions to exclude or strike 

redundant or immaterial evidence, 

motions to dismiss the case for 

insufficient evidence, or motions for 

summary judgment. Except for those 

made during the hearing, all motions 

and opposition to motions, including 

argument, must be in writing and be no 

more than 10 double-spaced pages in 

length. The presiding official will set a 

reasonable time for the party opposing 

the motion to reply. 

(5) Transcripts. The presiding official 

shall have the oral presentation 

transcribed and the transcript shall be 

made a part of the record. Either party 

may request a copy of the transcript and 

the requesting party shall be responsible 

for paying for its copy of the transcript. 

(f) Obstruction of Justice or Making of 

False Statements. Obstruction of justice 

or the making of false statements by a 

witness or any other person may be the 

basis for a criminal prosecution under 

18 U.S.C. 1505 or 1001. 

(g) Post-hearing Procedures. At their 

discretion, the presiding official may 

require or permit the parties to submit 

post-hearing briefs or proposed findings 

and conclusions. Each party may submit 

comments on any major prejudicial 

errors in the transcript. 

Section 16.9 Are there expedited 

procedures for review of immediate 

suspension? 

(a) Applicability. When the Secretary 

notifies an HHS-certified laboratory or 

IITF in writing that its certification to 

perform drug testing has been 

immediately suspended, the appellant 

may request an expedited review of the 

suspension and any proposed 

revocation. The appellant must submit 

this request in writing to the reviewing 

official within 3 days of the date the 

HHS-certified laboratory or IITF 

received notice of the suspension. The 

request for review must include a copy 

of the suspension and any proposed 

revocation, a brief statement of why the 

decision to suspend and propose 

revocation is wrong, and the appellant’s 

request for an oral presentation, if 

desired. A copy of the request for review 

must also be sent to the respondent. 

(b) Reviewing Official’s Response. As 

soon as practicable after the request for 

review is received, the reviewing official 

will send an acknowledgment with a 

copy to the respondent. 

(c) Review File and Briefs. Within 7 

days of the date the request for review 

is received, but no later than 2 days 

before an oral presentation, each party 

shall submit to the reviewing official the 

following: 

(1) A review file containing essential 

documents relevant to the review, 

which is tabbed, indexed, and organized 

chronologically; and 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining the 

party’s position concerning the 

suspension and any proposed 

revocation. No reply brief is permitted. 

(d) Oral Presentation. If an oral 

presentation is requested by the 

appellant or otherwise granted by the 

reviewing official, the presiding official 

will attempt to schedule the oral 

presentation within 7–10 days of the 

date of appellant’s request for review at 

a time and place determined by the 

presiding official following consultation 

with the parties. The presiding official 

may hold a prehearing conference in 

accordance with Section 16.8(c) and 

will conduct the oral presentation in 

accordance with the procedures of 

Section 16.8(e), (f), and (g). 

(e) Written Decision. The reviewing 

official shall issue a written decision 

upholding or denying the suspension or 

proposed revocation and will attempt to 

issue the decision within 7–10 days of 

the date of the oral presentation or 

within 3 days of the date on which the 

transcript is received or the date of the 

last submission by either party, 

whichever is later. All other provisions 

set forth in Section 16.14 will apply. 

(f) Transmission of Written 

Communications. Because of the 

importance of timeliness for these 

expedited procedures, all written 

communications between the parties 

and between either party and the 

reviewing official shall be by fax, 


ddrumheller on DSK120RN23PROD with RULES3
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations 70811 

secured electronic transmissions, or 

overnight mail. 

Section 16.10 Are any types of 

communications prohibited? 

Except for routine administrative and 

procedural matters, a party shall not 

communicate with the reviewing or 

presiding official without notice to the 

other party. 

Section 16.11 How are 

communications transmitted by the 

reviewing official? 

(a) Because of the importance of a 

timely review, the reviewing official 

should normally transmit written 

communications to either party by fax, 

secured electronic transmissions, or 

overnight mail in which case the date of 

transmission or day following mailing 

will be considered the date of receipt. In 

the case of communications sent by 

regular mail, the date of receipt will be 

considered 3 days after the date of 

mailing. 

(b) In counting days, include 

Saturdays, Sundays, and Federal 

holidays. However, if a due date falls on 

a Saturday, Sunday, or Federal holiday, 

then the due date is the next Federal 

working day. 

Section 16.12 What are the authority 

and responsibilities of the reviewing 

official? 

In addition to any other authority 

specified in these procedures, the 

reviewing official and the presiding 

official, with respect to those authorities 

involving the oral presentation, shall 

have the authority to issue orders; 

examine witnesses; take all steps 

necessary for the conduct of an orderly 

hearing; rule on requests and motions; 

grant extensions of time for good 

reasons; dismiss for failure to meet 

deadlines or other requirements; order 

the parties to submit relevant 

information or witnesses; remand a case 

for further action by the respondent; 

waive or modify these procedures in a 

specific case, usually with notice to the 

parties; reconsider a decision of the 

reviewing official where a party 

promptly alleges a clear error of fact or 

law; and to take any other action 

necessary to resolve disputes in 

accordance with the objectives of these 

procedures. 

Section 16.13 What administrative 

records are maintained? 

The administrative record of review 

consists of the review file; other 

submissions by the parties; transcripts 

or other records of any meetings, 

conference calls, or oral presentation; 

evidence submitted at the oral 

presentation; and orders and other 

documents issued by the reviewing and 

presiding officials. 

Section 16.14 What are the 

requirements for a written decision? 

(a) Issuance of Decision. The 

reviewing official shall issue a written 

decision upholding or denying the 

suspension or proposed revocation. The 

decision will set forth the reasons for 

the decision and describe the basis 

therefore in the record. Furthermore, the 

reviewing official may remand the 

matter to the respondent for such 

further action as the reviewing official 

deems appropriate. 

(b) Date of Decision. The reviewing 

official will attempt to issue their 

decision within 15 days of the date of 

the oral presentation, the date on which 

the transcript is received, or the date of 

the last submission by either party, 

whichever is later. If there is no oral 

presentation, the decision will normally 

be issued within 15 days of the date of 

receipt of the last reply brief. Once 

issued, the reviewing official will 

immediately communicate the decision 

to each party. 

(c) Public Notice. If the suspension 

and proposed revocation are upheld, the 

revocation will become effective 

immediately and the public will be 

notified by publication of a notice in the 

Federal Register. If the suspension and 

proposed revocation are denied, the 

revocation will not take effect and the 

suspension will be lifted immediately. 

Public notice will be given by 

publication in the Federal Register. 

Section 16.15 Is there a review of the 

final administrative action? 

Before any legal action is filed in 

court challenging the suspension or 

proposed revocation, respondent shall 

exhaust administrative remedies 

provided under this subpart, unless 

otherwise provided by Federal Law. The 

reviewing official’s decision, under 

Section 16.9(e) or 16.14(a) constitutes 

final agency action and is ripe for 

judicial review as of the date of the 

decision. 

[FR Doc. 2023–21734 Filed 10–11–23; 8:45 am] 

BILLING CODE 4162–20–P 


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