20522 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Chapter 1 

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: Notification of mandatory 

guidelines. 

SUMMARY: The Department of Health and 

Human Services (‘‘HHS’’ or 

‘‘Department’’) is proposing to revise the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Oral Fluid (OFMG) which published in 

the Federal Register of October 25, 

2019. 

DATES: Submit comments on or before 

June 6, 2022. 

ADDRESSES: In commenting, please refer 

to file code SAMHSA 2022–001. 

Because of staff and resource 

limitations, SAMHSA cannot accept 

comments by facsimile (fax) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

• Electronically. You may submit 

electronic comments on this document 

to https://www.regulations.gov. Follow 

‘‘Submit a comment’’ instructions. 

• By regular mail. You may mail 

written comments to the following 

address: SAMHSA, Center for Substance 

Abuse Prevention (CSAP), Division of 

Workplace Programs (DWP), 5600 

Fishers Lane, Room 16N02, Rockville, 

MD 20857. Please allow sufficient time 

for mailed comments to be received 

before the close of the comment period. 

• By express or overnight mail. You 

may send written comments to the 

following address: SAMHSA, CSAP, 

DWP, 5600 Fishers Lane, Room 16N02, 

Rockville, MD 20857. 

• By hand or courier. You may 

deliver your written comments by hand 

or courier to the following address prior 

to the close of the comment period: 

SAMHSA, CSAP, DWP, 5600 Fishers 

Lane, Room 16N02, Rockville, MD 

20857. If you intend to deliver your 

comments to the Rockville address, 

please call (240) 276–2600 in advance to 

schedule your arrival with one of our 

staff members. Because access to the 

SAMHSA building is secure, persons 

without Federal Government 

identification are encouraged to 

schedule their delivery or to leave 

comments with the security guard at the 

front desk located in the main lobby of 

the building. 

All comments received before the 

close of the comment period will be 

available for viewing by the public. 

Please note that all comments are posted 

in their entirety, including personal or 

confidential business information that is 

included in the comment. SAMHSA 

will post all comments before the close 

of the comment period on the following 

website: https://www.regulations.gov. 

Use the website’s search function to 

view the associated comments. 

Comments received before the close of 

the comment period will also be 

available for public inspection as they 

are received, generally beginning 

approximately three weeks after 

publication of a document, at SAMHSA, 

CSAP, DWP, 5600 Fishers Lane, 

Rockville, MD 20857, Monday through 

Friday of each week, excluding Federal 

holidays, from 8:30 a.m. to 4:00 p.m. To 

schedule an appointment to view public 

comments, please call (240) 276–2600. 

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 

This notification of proposed 

revisions to the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Oral Fluid (OFMG) 

includes revisions that will: 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 

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 Urine (UrMG), 

82 FR 7920 (January 23, 2017), 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 proposing revisions to 

the OFMG, including the same or 

similar revisions proposed for the 

UrMG, where appropriate. 

Background 

The Department of Health and Human 

Services, pursuant to the Department’s 

authority under Section 503 of Public 

Law 100–71, 5 U.S.C. Section 7301, and 

Executive Order 12564, 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 oral fluid specimens at this 

time. 

As required, HHS originally 

published the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs (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 HHS published the 

current Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Oral Fluid (OFMG) on 

October 25, 2019 (84 FR 57554). 

Proposed Revisions to the HHS 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

Authorized Drug Testing Panel 

The Guidelines pertain to a matter of 

Federal agency personnel and, therefore, 

are not subject to the notification and 

comment procedures under the 

Administrative Procedures Act. In light 

of the potential impact on entities 

outside of the Federal Government, the 

Department has chosen to submit the 

Guidelines to notification and comment, 


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and will continue to do so. In this 

revision, the Department is proposing to 

change the way a specific part of the 

Guidelines (i.e., the drug testing panel) 

is published and the frequency with 

which it is published. 

Since the original Guidelines were 

published in 1988, several 

recommendations have been made for 

drugs to be added to or removed from 

Federal workplace drug testing 

programs. The Department has revised 

the Guidelines in the past to add or 

remove drugs from the authorized drug 

testing panel and to revise test cutoffs 

(i.e., Section 3.4 of the UrMG). The time 

required to revise the Guidelines 

through the Federal review process has 

impeded the Department’s ability to 

respond to drug use trends. Individuals 

may change their drug use, and illicit 

drug manufacturers may change their 

manufacturing methods, to avoid testing 

positive for drugs included in proposed 

Guidelines, especially as the number of 

new drugs and drug analogues 

increases. A less flexible drug testing 

panel may delay needed drug analyte or 

cutoff changes based on the state of the 

science (e.g., new technologies, research 

including dosing studies). Therefore, the 

Department proposes to publish the 

drug testing panel in the Federal 

Register on an annual basis, including 

any revisions to the panel, without the 

need (perceived or otherwise) to 

undergo notification and comment. 

Should the Department remove a drug 

from the drug testing panel, a Federal 

agency may test specimens for that drug 

in accordance with Section 3.2 (i.e., on 

a case-by-case basis for reasonable 

suspicion or post accident testing, or 

routinely with a waiver from the 

Secretary). This process is expected to 

improve the effectiveness of Federal 

agency drug testing programs in support 

of the Federal Drug-Free Workplace 

Program. The drug testing panel in 

Section 3.4 of the final OFMG will 

remain in effect until the effective date 

of a newly published drug testing panel. 

The Department will continue to 

monitor drug use trends and review 

information on new drugs of abuse from 

sources such as Federal regulators, 

researchers, the drug testing industry 

(including HHS-certified laboratories), 

and public and private sector 

employers, to determine whether drugs 

should be added or removed from the 

panel. Any changes to analytes and 

cutoffs made in accordance with the 

newly established drug testing panel 

publishing process will be based on a 

thorough review of relevant 

information, including the current state 

of the science, laboratory capabilities, 

cost associated with the change, and 

benefits of the change to Federal 

agencies. The Department will set a date 

for the panel changes to take effect and 

include the effective date in the annual 

drug testing panel FRN, in order 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 HHScertified laboratories to develop or 

revise assays, complete validation 

studies, and revise procedures. The 

prior version of the panel will remain in 

effect until the effective date of the 

panel changes. 

For consistency and to avoid 

misinterpretation of drug test results, 

the Department is requiring HHScertified laboratories and HHS-certified 

instrumented initial test facilities 

(collectively referred to hereafter as 

‘‘HHS-certified test facilities’’) and 

Medical Review Officers (MROs) to 

report results using the nomenclature 

(i.e., analyte names and abbreviations) 

published with the drug testing panel. 

Authorized Biomarker Testing Panel 

A biomarker is an endogenous 

substance used to validate a biological 

specimen. The purpose of a biomarker 

test is to determine whether a submitted 

specimen is a human specimen. The 

current OFMG (effective January 1, 

2020) allow additional specimen 

validity testing using biomarkers upon 

MRO request, to provide information to 

assist the MRO in the verification 

process. The current OFMG also require 

HHS-certified laboratories to report a 

specimen as invalid when the biomarker 

is not present or when its concentration 

is not consistent with that established 

for human oral fluid but does not allow 

these specimens to be reported as 

substituted. The Department proposes to 

revise the OFMG to define such 

specimens as substituted, and to allow 

only biomarker tests that have been 

authorized by SAMHSA for use in 

Federal agency workplace drug testing 

programs. 

To ensure that scientifically valid 

biomarker tests, analytes, and cutoffs are 

standardized for Federal workplace drug 

testing, the Department will institute an 

approval process for biomarker tests, 

based on review of data from the 

scientific and/or medical literature, 

before authorizing the use of the 

biomarker test. The Department will 

accept scientific information submitted 

for review from various sources (e.g., 

HHS-certified test facilities, drug testing 

industry stakeholders, researchers). The 

Department will include the authorized 

biomarker testing panel (i.e., a table of 

authorized biomarkers, with test 

analytes and cutoffs), in the FRN to be 

published each January (as described 

earlier in this preamble). Federal 

agencies may choose to test some or all 

of their workplace specimens for one or 

more authorized biomarkers. 

An HHS-certified laboratory or (for 

urine only) an HHS-certified 

instrumented initial test facility (IITF) 

may request authorization from 

SAMHSA to conduct a biomarker test 

that has not been included on the list of 

authorized biomarkers. The test facility 

must submit supporting documentation 

and assay validation records to the 

National Laboratory Certification 

Program (NLCP) for SAMHSA review 

and approval. When an oral fluid 

biomarker test is approved through this 

process, SAMHSA will authorize the 

individual HHS-certified laboratory to 

perform the biomarker test for federally 

regulated specimens only upon MRO 

request (i.e., a blanket request for all 

specimens or a case-by-case request for 

a specific specimen). A certified 

laboratory may choose to begin the 

process by submitting supporting 

documentation for review prior to assay 

validation, or may send supporting 

documentation with completed 

validation records. The Department will 

include measurands and decision points 

for other specimen validity tests in the 

OFMG (e.g., Section 11.17). 

Once a biomarker test has been added 

to the authorized biomarker panel 

published in the FRN, HHS-certified 

laboratories may routinely conduct the 

test without requiring an MRO request, 

and only require a signed MRO request 

for case-by-case biomarker testing (in 

accordance with OFMG section 3.5). 

The Department will continue to require 

NLCP review of biomarker assay 

validation records before allowing a 

laboratory to use the test for federally 

regulated workplace specimens. 

This process will facilitate the 

identification of donors who attempt to 

subvert their drug test, and ensure that 

biomarker tests used for federally 

regulated workplace programs are 

scientifically supportable and properly 

validated, and that all HHS-certified test 

facilities use the same analytes and 

cutoffs. 

For consistency and to avoid 

misinterpretation of biomarker test 

results, the Department is requiring 

HHS-certified test facilities and Medical 

Review Officers (MROs) to report results 

using the nomenclature (i.e., analyte 

names and abbreviations) published 

with the biomarker testing panel. 


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20524 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Proposed Rules 

Medical Review Officer (MRO) 

Verification of Codeine and Morphine 

Test Results 

The MRO has an essential role in 

federally regulated workplace drug 

testing programs, which includes 

performing the review of laboratory 

results and supporting documentation, 

interviewing the donor when necessary, 

and making a final determination 

regarding the result. 

As described in Section 13.5(c)(2) of 

the current OFMG, when a donor has no 

legitimate medical explanation for a 

positive codeine or morphine result 

equal to or greater than 150 ng/mL, the 

MRO reports the specimen as positive to 

the agency. When a donor has no 

legitimate medical explanation for a 

positive codeine or morphine result less 

than 150 ng/mL, the MRO must 

determine that there is clinical evidence 

of illegal opioid use (in addition to the 

test results) to report such specimens as 

positive. If the MRO finds no clinical 

evidence of illegal opioid use, the MRO 

verifies the opiate results as negative. 

The Department is maintaining 150 ng/ 

mL as a conservative decision point to 

rule out results that may have been due 

to poppy seed ingestion rather than 

illicit drug use. Because MROs routinely 

conduct donor interviews by telephone, 

rather than in-person, some MROs have 

expressed concern to the Department 

over the feasibility of the current 

requirement to make a clinical 

assessment (i.e., physical examination) 

of the donor. In light of this information, 

the Department reviewed the 

verification procedures and determined 

that the additional requirement for 

clinical evidence of illegal opioid use is 

no longer practical or effective. The 

Department proposes to revise the 

procedures, now in renumbered Section 

13.5(c)(3), to remove the requirement for 

the MRO to report specimens with 

morphine and/or codeine between the 

cutoff and 150 ng/mL as positive based 

on clinical evidence of illicit drug use. 

The MRO will verify such specimens as 

negative unless the donor admits to 

illegal opioid use that could have 

caused the positive result. The revised 

procedures will provide a reliable and 

objective basis for identifying illicit 

drug use, based on current scientific 

information and industry practice. 

Retaining the decision point may 

provide useful information on opioids, 

as the Department can use the semiannual MRO reports (described below) 

to compare results of specimens with 

morphine and codeine concentrations 

between the cutoff and 150 ng/mL to 

results of other opioids, including 6- 

acetylmorphine. 

Medical Review Officer (MRO) 

Semiannual Reports 

The Department, through the NLCP, 

obtains information from HHS-certified 

laboratories that is reviewed to verify 

accurate reports and compliance with 

Guidelines requirements. The NLCP 

conducts statistical analysis and 

provides reports to the Department on 

federally regulated workplace testing, 

although the data are limited to 

laboratory-reported results and not the 

final, MRO-verified results. To obtain 

additional information needed to assess 

compliance with the Mandatory 

Guidelines, the Department proposes to 

require 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). The reports will 

not contain any personally identifiable 

information of the donors. 

This revision to the Guidelines will 

enable Department oversight of MRO 

reporting practices and will enhance the 

Department’s ability to verify the 

accuracy of MRO reports and address 

areas of confusion about Guidelines 

requirements. The information in the 

MRO reports will be matched to 

information submitted to the NLCP by 

HHS-certified laboratories for the same 

specimens. This additional information 

will improve statistical analyses and 

provide a clearer picture of illicit drug 

use by Federal job applicants and 

employees. 

MROs may also experience some 

savings because the removal of the 

clinical evaluation requirement for some 

codeine and morphine positive results 

will simplify the MRO verification 

process. 

Proposed Revisions to the Guidelines 

This preamble describes the proposed 

revisions to the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Oral Fluid (OFMG), and 

the rationale for the changes. 

Subpart A—Applicability 

Section 1.5 defines terms used in the 

OFMG. The Department has added 

terms and revised definitions in this 

section in accordance with proposed 

changes to these Guidelines, and to 

standardize terms and definitions, 

where possible, to apply to all 

authorized specimen types. 

The Department proposes to revise 

the Substituted Specimen definition to 

include specimens tested for a 

biomarker, when the biomarker is 

absent or is present at a concentration 

inconsistent with that established for a 

human specimen. For clarity, the 

Department also added a reference to 

the oral fluid specimen reporting 

criteria for substitution in Section 3.7 of 

the UrMG. For clarity and for 

consistency with the revised Substituted 

Specimen definition, the Department 

proposes to edit the Adulterated 

Specimen definition to apply to 

specimens with ‘‘an abnormal 

concentration of a normal constituent 

(e.g., nitrite in urine’’), rather than ‘‘an 

abnormal concentration of an 

endogenous substance’’; revise 

definitions for Cutoff and Initial 

Specimen Validity Test to remove the 

‘‘(for urine)’’ specification for 

identifying a substituted specimen; and 

revise the Invalid Result definition to 

mention both ‘‘adulterated’’ and 

‘‘substituted’’ as results that may be 

determined for an oral fluid specimen. 

The Department proposes to revise the 

Collection Container definition to apply 

to all authorized specimen types, by 

changing ‘‘a urine specimen’’ to ‘‘a 

donor’s drug test specimen.’’ The 

Department has also added definitions 

for ‘‘Biomarker Testing Panel’’ and 

‘‘Drug Testing Panel’’ consistent with 

the proposed publication of these 

testing panels in a separate FRN each 

year. 

Section 1.7 describes what constitutes 

a donor’s refusal to take a federally 

regulated drug test. Section 1.7(a) 

includes exceptions for a donor who 

fails to appear in a reasonable time for 

a pre-employment test and a donor who 

leaves the collection site before the 

collection process begins for a preemployment test. The Department finds 

that there is no justification for altering 

a refusal to test based on whether the 

test is being conducted in the 

employment or pre-employment context 

and, therefore, proposes to remove these 

exceptions. The collector will report a 

refusal to test for any donor who fails 

to appear in a reasonable time or who 

leaves the collection site before the 

collection is complete, regardless of the 

reason for the test. 

The Department also revised Section 

1.7(a)(7) to include a donor’s refusal to 

wash their hands when directed to do 

so by the collector as an example of a 

refusal to test by failing to cooperate 

with the testing process. See also 

Section 8.4(a). 

Section 1.8(a) describes the potential 

consequences for a refusal to test. The 

Department has reworded this section to 

clarify potential actions for a Federal 

employee who refuses to take a drug 


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test, and the potential action for an 

applicant who refuses to take a preemployment test. 

Subpart C—Oral Fluid Specimen Tests 

The Department proposes to edit 

Section 3.1 to reflect the proposed 

process for publishing drug and 

biomarker testing panels in an FRN each 

year containing a list of authorized drug 

analytes and biomarkers that can be 

tested. As described under Authorized 

drug testing panel and Authorized 

biomarker testing panel above, the time 

required to revise the Guidelines 

through the Federal review process has 

impeded the Department’s ability to 

respond to drug use trends, and to make 

drug analyte or cutoff changes based on 

the state of the science (e.g., new 

technologies, research including dosing 

studies). This new process is expected 

to improve the effectiveness of Federal 

agency drug testing programs in support 

of the Federal Drug-Free Workplace 

Program. See also Section 3.4. 

The Department also revised item 

3.1(c) to remove albumin or 

immunoglobulin G (IgG) tests as 

examples of biomarker tests, and to 

allow specimen validity tests that could 

be used to identify specimens that are 

not valid for testing. See also Sections 

3.8 and 11.17(g). 

For clarity, the Department also 

revised the header for Section 3.2 to 

refer to ‘‘drugs other than those in the 

drug testing panel’’ (see above) rather 

than ‘‘additional drugs’’. 

The Department has revised Section 

3.4 of the OFMG to describe the 

proposed publication of a final 

notification in the Federal Register each 

year that will include the authorized 

drugs, test analytes, and cutoffs; the 

authorized biomarkers, test analytes, 

and cutoffs; and the nomenclature 

required for laboratory and MRO 

reports. The annual notification will be 

posted on the SAMHSA website, 

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

The table in Section 3.4 of the final 

OFMG will remain in effect until the 

effective date of the new panels 

published in the separate FRN. 

The Department proposes to add a 

new Section 3.7 and revise Section 3.8 

to require specimens to be reported as 

substituted based on a biomarker 

concentration outside the range 

established for that biomarker in human 

oral fluid, rather than reporting such 

results as invalid. See also Section 1.5. 

Section 3.8 also addresses specimen 

validity tests that could be used to 

identify invalid specimens. See also 

Sections 3.1 and 11.17(g). 

Subpart G—Oral Fluid Specimen 

Collection Devices 

The Department proposes to revise 

Section 7.2(b) to clarify that, depending 

on the device type, a collection device 

may include one or two specimen tubes 

for a split specimen collection. The 

Department also proposes to add two 

new requirements for collection devices 

in this section. 

In Section 7.2(b)(2), the Department 

added a requirement for oral fluid 

specimen tubes to be sufficiently 

transparent to enable a visual 

assessment of the contents without 

opening the tube. This will enable the 

collector to identify oral fluid 

specimens with abnormal physical 

characteristics and take action (e.g., 

recollection) to obtain an acceptable 

specimen. See also Section 8.5(a)(3). 

In Section 7.2(b)(3), the Department 

added a requirement for the collection 

device manufacturer to include the 

device lot expiration date on each 

specimen tube. The collector will check 

the expiration date of each device prior 

to use and document this action on the 

Federal Custody and Control Form 

(CCF), and the laboratory accessioner 

will check and document the expiration 

date on both A and B specimen tubes 

upon receipt. As described below 

regarding Section 15.1, laboratories 

must reject oral fluid specimens 

collected using an expired device. 

Subpart H—Oral Fluid Specimen 

Collection Procedure 

The Department is proposing 

revisions to the oral fluid collection 

procedures as described below, for 

clarity and for consistency with the 

2020 Federal CCF and with the Oral 

Fluid Specimen Collection Handbook, 

which were both finalized following 

OFMG publication in 2019. 

Proposed revisions to Section 8.3 

include reordering collection steps (e.g., 

item d, item h.4) and rewording for 

clarity (e.g., items g and h). The 

Department also added steps similar to 

those for urine collections, to deter 

donor attempts to adulterate or 

substitute the specimen. The added 

requirement for the collector to inspect 

the contents of the donor’s pockets 

applies only when the collector does not 

keep the donor under direct observation 

until the end of the collection, including 

the 10-minute wait period described in 

section 8.3(h). Unlike a urine collection, 

if the donor refuses to display the 

contents of their pockets, the collector 

will continue with the oral fluid 

collection, but will keep the donor 

under their direct observation. This is 

not a refusal to test. In Section 8.3(h)(4), 

the Department clarified that the 

collector must inform the donor that the 

donor’s failure to remain at the 

collection site until the collection is 

complete will be reported as a refusal to 

test. This is consistent with Section 1.7. 

The Department revised wording in 

Section 8.3(f) regarding how 

instructions for completing the Federal 

CCF are provided to the donor. This is 

consistent with changes made to the 

Federal CCF to enable its use with both 

urine and oral fluid specimens. 

The Department also proposes to add 

steps in Section 8.4 to deter donor 

attempts to tamper with the specimen. 

Proposed revisions include a new item 

requiring the donor to wash their hands 

under the collector’s observation, and to 

keep their hands within view and avoid 

touching items or surfaces after 

handwashing. A donor’s refusal to wash 

their hands when instructed by the 

collector constitutes a refusal to test. In 

Section 8.4(b), the Department added a 

new item 1 specifying that the collector 

opens the package containing the 

specimen collection device, in the 

presence of the donor. In Section 8.4(d), 

the Department added ‘‘an attempt to 

prevent the device from collecting 

sufficient oral fluid’’ to the examples of 

donor attempts to tamper with a 

specimen. The Oral Fluid Specimen 

Collection Handbook includes 

additional examples of tampering 

attempts. 

In Section 8.5, the Department added 

a new item a.3 requiring the collector to 

check each collected specimen for 

abnormal physical characteristics. See 

also Section 7.2. 

The Department also revised the 

wording in Section 8.9(a)(3) for clarity. 

Subpart I—HHS Certification of 

Laboratories 

Section 9.5 describes the qualitative 

and quantitative specifications for oral 

fluid performance test (PT) samples. In 

item a.2, the Department added that a 

PT sample may contain an adulterant or 

may satisfy the criteria for a substituted 

specimen or invalid result. 

Section 9.6 describes PT requirements 

for an applicant laboratory and Section 

9.7 describes PT requirements for an 

HHS-certified laboratory. The 

Department has added requirements for 

specimen validity testing challenges in 

new items (a)(7) through (a)(10) in both 

sections. In addition, the Department is 

proposing to edit Section 9.7(a)(5) to 

state clearly that quantitative values 

reported for drug tests are evaluated 

based on reported results for each PT 

cycle, not on cumulative results 

reported over two consecutive PT 

cycles. An HHS-certified laboratory 


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must not obtain a quantitative value 

outside the specified range for a drug, 

based on the appropriate reference or 

peer group mean. 

Subpart K—Laboratory 

Section 11.17 describes the 

requirements for an HHS-certified 

laboratory to report primary (A) 

specimen test results to an MRO. The 

Department proposes to add the 

requirements for reporting an oral fluid 

specimen as adulterated in item 

11.17(d) and as substituted in item 

11.17(e). See also Section 1.5. 

Section 11.17(g) addresses laboratory 

and MRO discussions to determine 

whether additional testing may be 

useful for specimens with certain 

invalid results. Because biomarker 

testing could be used to identify 

substitution, the Department has revised 

this section to indicate that additional 

testing may be useful in being able to 

report a substituted result, as well as 

positive or adulterated results. The 

Department has also reworded item 

11.17(g) to allow laboratories to report 

specimens as invalid based on specimen 

validity tests. See also Sections 3.1 and 

3.8. 

Section 11.17(i) and 11.17(p) includes 

requirements for the laboratory to report 

‘‘non-negative’’ results for a specimen to 

the MRO. The Department is adding 

‘‘substituted’’ to the list of non-negative 

results in these sections. 

The Department also proposes to add 

a new item 11.17(l) stating that the 

laboratory must use the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels on reports. 

This change is to ensure consistency in 

reporting and interpretation of test 

results, by requiring the results of each 

test performed to be reported using clear 

and correct nomenclature for test 

analytes, with the same terminology and 

units of measurement. See also Section 

3.4. 

Section 11.18 addresses how long 

specimens must be retained by the 

laboratory. The Department proposes to 

edit item a to require HHS-certified 

laboratories to retain specimens 

reported as substituted for at least one 

year (i.e., the same as specimens 

reported as positive, adulterated, or 

invalid). The Department is also 

revising item b of this section to require 

laboratories to maintain oral fluid 

specimens in accordance with the 

collection device manufacturer’s 

instructions (i.e., frozen at ¥20 °C or 

less, or refrigerated). 

Section 11.20 describes information 

that must be included on HHS-certified 

laboratories statistical summary reports 

for oral fluid testing. The Department 

proposes to require laboratories to 

include the number of substituted 

specimens. 

Section 11.21 describes HHS-certified 

laboratory information that is available 

to a Federal agency. The Department 

proposes to add that an agency may 

request records of specimens reported as 

substituted. 

Subpart M—Medical Review Officer 

(MRO) 

Section 13.5(b)(2) describes MRO 

actions when a laboratory reports an 

invalid result in conjunction with a 

positive, adulterated, or substituted 

result. The Department has revised this 

section to include substituted as well as 

positive or adulterated results. The 

Department has added an item to this 

section to clarify that the MRO takes the 

required action for the invalid result 

(specified in item e of this section) only 

when the MRO has verified the other 

result(s) for the specimen (i.e., positive, 

adulterated, or substituted) as negative 

or when the split (B) specimen was 

tested and reported as a failure to 

reconfirm. 

Section 13.5(c) describes MRO actions 

to determine whether the donor has a 

legitimate medical explanation for a 

positive specimen test result. The 

Department added a new item Section 

13.5(c)(1) to clarify that the MRO reports 

a positive result when the donor admits 

unauthorized use of the drug(s) that 

caused the positive test result, and 

documents the admission of 

unauthorized drug use in the MRO 

records and in the MRO’s report to the 

Federal agency. A donor’s admission of 

unauthorized drug use corroborates the 

positive test. 

Currently, Section 13.5(c)(1) includes 

the policy of the Department that 

ingestion of food products containing 

marijuana is not an acceptable medical 

explanation for a positive drug test 

result. The Department proposes to 

reword this policy, now in item ii of 

Section 13.5(c)(2), to clarify that the 

policy applies to any positive oral fluid 

drug test results, not just marijuana, 

with the exception of positive codeine 

and morphine results less than 150 ng/ 

mL as described in Section 13.5(d). The 

section now states that ingestion of food 

products containing a drug is not an 

acceptable medical explanation for a 

positive drug test, with ‘‘products 

containing marijuana’’ as an example. 

The Department also proposes to add a 

new item iii to this section stating that 

a physician’s authorization or medical 

recommendation for a Schedule I 

substance is not an acceptable medical 

explanation for a positive drug test. 

Under the Controlled Substances Act 

CSA, a Schedule I substance is defined 

as a drug, chemical, or other substance 

with no currently accepted medical use 

in the United States, a lack of accepted 

safety for use under medical 

supervision, and a high potential for 

abuse. (Ref. 1) The Drug Enforcement 

Administration (DEA) maintains the 

current listing of controlled substances 

on their website. 

Section 13.5.(c)(3) describes MRO 

actions when the donor has no 

legitimate medical explanation for a 

positive drug test result, and includes 

exceptions for codeine and morphine 

results. As described above under 

Medical Review Officer (MRO) 

verification of codeine and morphine 

test results, the Department proposes to 

maintain the 150 ng/mL decision point 

used to rule out codeine and morphine 

results that may have been due to poppy 

seed ingestion rather than illicit drug 

use, and remove the additional 

requirement for clinical evidence of 

illegal opioid use. MROs will verify 

positive codeine and morphine results 

less than 150 ng/mL as negative, and 

will include the specimen in the 

required report of verified negative 

specimens described under Section 

13.11 below. If the donor admits 

unauthorized drug use during their 

interview with the MRO that could have 

caused the positive result, the MRO 

verifies the result as positive. 

The Department also proposes to 

revise Section 13.5(c)(3) to address 

substituted oral fluid specimens where 

appropriate. 

Section 13.9 describes how an MRO 

reports primary (A) drug test results to 

an agency. The Department proposes to 

add a new item 13.9(e) stating that the 

MRO must use the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels on reports. 

See also Section 3.4. 

The Department has included a new 

Section 13.11 describing the proposed 

requirement for an MRO to send 

semiannual reports to the Secretary or 

designated HHS representative for 

Federal agency specimens that were 

reported as positive by a laboratory and 

verified as negative by the MRO. As 

described under Medical Review Officer 

(MRO) semiannual reports above, this 

change will enable Department 

oversight of MRO practices and will 

enhance the Department’s ability to 

verify the accuracy of MRO reports and 

address areas of confusion about 

Guidelines requirements. In addition, 

the information in the MRO reports will 

be matched to information submitted to 

the NLCP by HHS-certified laboratories 

for the same specimens, thereby 

improving statistical analyses and 


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providing a clearer picture of illicit drug 

use by Federal job applicants and 

employees. The reports must not 

include any personally identifiable 

information for the donor, and must be 

submitted within 14 working days after 

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

in July and January). Section 13.11 lists 

the information that must be included 

on the reports. To facilitate report 

preparation and review, the Department 

will include a template for these MRO 

reports in the MRO Guidance Manual 

and will arrange a secure method for 

MROs to submit reports electronically. 

The Department has included a new 

Section 13.12 describing the Federal 

agency’s responsibilities for designating 

an MRO. These responsibilities include 

verifying and documenting that 

individuals meet the MRO requirements 

in these Guidelines before allowing 

them to serve as an MRO for the 

agency’s drug testing program and on an 

ongoing basis, and ensuring that each 

MRO reports drug test results in 

accordance with the Guidelines. 

Further, the Federal agency must obtain 

documentation from the MRO to 

confirm that the MRO and any external 

service provider ensures the 

confidentiality integrity and availability 

of the data and limits the access to any 

data transmission, storage, and retrieval 

system. 

Subpart N—Split Specimen Tests 

The Department proposes to add a 

new Section 14.4 describing how an 

HHS-certified laboratory reports a split 

(B) oral fluid specimen when the 

primary (A) specimen was reported 

substituted. The Department proposes to 

revise this section to address primary 

(A) specimens reported as substituted 

based on biomarker test results. See also 

Section 1.5. 

Section 14.5 states that the HHScertified laboratory that tested a split (B) 

specimen must report the results to the 

MRO. The Department proposes to 

reword this section to require the 

laboratory to use the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels on reports 

for split (B) specimens. See also Section 

3.4. 

Section 14.6 describes the actions an 

MRO takes after receiving a split (B) oral 

fluid specimen result from an HHScertified laboratory. The Department 

proposes to revise this section to 

address MRO verification of split (B) 

specimen results when the primary (A) 

specimen was reported as substituted, 

and when a B specimen was reported as 

substituted based on biomarker See also 

Section 1.5. The Department also 

proposes to add a new item 14.6(k) to 

address MRO verification of split (B) 

specimen results when the B specimen 

fails to reconfirm adulteration or 

substitution and is invalid. 

Section 14.7 describes how an MRO 

reports split (B) specimen test results to 

an agency. The Department proposes to 

add a new item 14.7(e) stating that the 

MRO must use the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels on reports. 

See also Section 3.4. 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

The Department is proposing to add a 

new item c to Section 15.1, requiring the 

laboratory to reject oral fluid specimens 

collected using an expired device (i.e., 

when the expiration date on the 

specimen tube precedes the collection 

date), unless the split (B) specimen can 

be redesignated as the primary (A) 

specimen. See also Section 7.2. 

General Revisions 

In addition to the proposed changes 

described by subpart and section above, 

the Department has edited the OFMG to 

address proposed changes (e.g., 

removing ‘‘for urine’’ when referring to 

substituted specimens; referencing the 

proposed annual FRN with drug and 

biomarker testing panels) and has 

reworded some items for clarity and/or 

for consistency with the UrMG. 

Impact of These Guidelines on 

Government Regulated Industries 

The Department is aware that these 

proposed new Guidelines may impact 

the Department of Transportation (DOT) 

and Nuclear Regulatory Commission 

(NRC) regulated industries depending 

on these agencies’ decisions to 

incorporate the final OFMG revisions 

into their programs under their own 

authority. 

Costs and Benefits 

Costs 

The proposed OFMG revision to 

publish the drug testing panel in a 

separate FRN each January (e.g., Section 

3.4) may result in a cost increase for 

HHS-certified laboratories and MROs 

(e.g., costs for test supplies, assay 

validation, administrative changes) 

when a new drug is added to the panel 

or when analytes or cutoffs are changed 

for current drugs. The added costs will 

depend on the change. For example, 

implementation costs would be lower 

for laboratories that already offer the 

drug test or use the different analyte or 

cutoff for their non-regulated clients. 

MROs may experience increased costs 

when an agency chooses to test their 

Federal job applicants and employees 

for a new authorized drug with a high 

positivity rate or a Schedule II drug 

requiring the MRO to review medical 

explanations. Additional costs for 

testing and MRO review will be 

incorporated into the overall cost for the 

Federal agency submitting the specimen 

to the laboratory. Added costs to MROs 

would be expected to shift to Federal 

agencies over time, as existing contracts 

expire and new contract terms are 

negotiated. As noted earlier in this 

preamble, the Department will consider 

costs when deciding whether to make a 

change to the authorized drug tests. At 

this time, the Department will not 

require HHS-certified laboratories to 

implement authorized biomarker tests. 

Each laboratory should conduct their 

own cost analysis when deciding 

whether to offer biomarker testing to 

federally regulated clients. The 

Department will consider costs when 

deciding whether to require all certified 

laboratories to test for a specific 

biomarker. 

There will be some administrative 

costs for MROs associated with the 

generation and submission of the 

semiannual reports of verified-negative 

results (see Section 13.11). The 

Department encourages the use of 

electronic recordkeeping to facilitate 

information retrieval and report 

generation, and will enable secure 

submission of electronic information to 

reduce MRO costs to provide these 

reports. 

Benefits 

The potential benefits of more timely 

changes to the drug testing panel will 

result in a healthier and more 

productive workforce, as well as avoid 

the issues associated with addiction and 

rehabilitation. Since the personnel 

tested under this program are in 

positions that are safety sensitive, 

potential benefits include decreased risk 

of transportation and workplace 

accidents, decreased risk of lowprobability high consequence events, a 

more responsible workforce in positions 

of public trust, and potentially reducing 

individuals’ dependence or addiction 

and the personal benefits associated 

with those conditions. Considering the 

potential health and performance costs 

of drug misuse, the benefits to the 

Federal workplace and the individuals 

within that workplace justify the more 

agile method of changing the drug 

testing panel for the Federal workplace 

drug testing programs. 

The number of commercial 

substitution and adulteration products 

aimed at defeating a drug test continues 

to proliferate for both urine and oral 

fluid. Manufacturers alter their existing 


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20528 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Proposed Rules 

products or develop new products to 

subvert drug and specimen validity tests 

in federally regulated workplace 

programs. (Ref. 2 and 3) When the 

Department added provisions for 

biomarker testing in the current OFMG, 

the intent was to identify non-human 

oral fluid samples that were submitted 

for testing in place of the donor’s oral 

fluid. The proposed revision to report a 

specimen as substituted (not invalid) 

based on biomarker testing is consistent 

with this intention. This revision, as 

well as the Department review and 

approval of biomarker tests and the 

added flexibility for making changes to 

the drug and biomarker testing panels, 

will strengthen the Federal 

Government’s ability to identify illicit 

drug use and donor attempts to subvert 

drug tests. 

The proposed requirement for 

semiannual MRO reports on laboratorypositive/MRO- negative results will 

enable the Department to ensure 

accurate reports and MRO compliance 

with Guidelines requirements. The 

information in the MRO reports will be 

matched to information for the same 

specimens that was submitted to the 

NLCP by the HHS-certified laboratory, 

thereby improving statistical analyses 

and providing a clearer picture of illicit 

drug use by Federal job applicants and 

employees. 

MROs may also experience some 

savings, as the removal of the clinical 

evaluation requirement for some 

codeine and morphine positive results 

will simplify the MRO verification 

process. 

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 

oral fluid 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 (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 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 has set a deadline of 

August 31, 2023, for all HHS-certified 

laboratories to submit a request for 

approval of an electronic (paperless) 

Federal CCF. 

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 Oral Fluid. 

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: 10,500 donors 

who apply for employment or are 

employed in testing designated 

positions, 100 collectors, 10 oral fluid 

specimen testing laboratories, 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 

9.10(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 

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

agency.

10 5 0.5 25 

13.9 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 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Proposed Rules 20529 

ESTIMATE OF ANNUAL REPORTING BURDEN—Continued 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

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 

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 ........................ .............................................................................. 256 ........................ ........................ 392 

The following reporting requirements 

are also in the proposed 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 an oral fluid 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), 8.6(b)(2) ............. Collector must contact Federal agency point of 

contact.

100 1 0.05 (3 min) 5 

11.21, 11.22 ................... Information on drug test that laboratory must 

provide to Federal agency upon request or to 

donor through MRO.

25 10 3 750 

13.8(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 ........................ .............................................................................. 225 ........................ ........................ 4,955 

The following disclosure 

requirements are also included in the 

proposed 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(h)). 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, 8.4, 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) & 11.17 .............. Laboratory completes Federal CCF upon receipt 

of specimen and before reporting result.

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

13.4(d)(4),13.9(c),14.7(c) MRO completes Federal CCF before reporting 

the primary or split specimen result.

100 380 0.05 (3 min) 1,900 


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ESTIMATE OF ANNUAL RECORDKEEPING BURDEN—Continued 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

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

specimen tested.

100 2 0.05 (3 min) 10 

Total ........................ .............................................................................. 38,325 ........................ ........................ 9,510 

The proposed 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 

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 

(Section 8.4(d)) requires collectors to 

enter any information on the Federal 

CCF of any unusual findings during the 

oral fluid 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; 11.10(a); 11.13(a); 11.16; 

11.19(a), (b), and (c); 11.20; 11.21(a); 

and 11.22). These recordkeeping 

requirements are necessary for any 

laboratory to conduct forensic drug 

testing and to ensure the scientific 

supportability of the test results. 

Therefore, they are considered to be 

standard business practice and are not 

considered a burden for this analysis. 

Thus, the total annual response 

burden associated with the testing of 

oral fluid specimens by the laboratories 

and IITFs is estimated to be 14,857 

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 oral fluid 

testing under the current Guidelines. 

As required by section 3507(d) of the 

PRA, the Secretary has submitted a copy 

of these proposed Guidelines to OMB 

for its review. Comments on the 

information collection requirements are 

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. 

OMB is required to make a decision 

concerning the collection of information 

contained in these proposed Guidelines 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

to OMB is best assured of having its full 

effect if OMB receives it within 30 days 

of publication. This does not affect the 

deadline for the public to comment to 

HHS on the proposed Guidelines. 

Organizations and individuals 

desiring to submit comments on the 

information collection requirements 

should direct them to the Office of 

Information and Regulatory Affairs, 

OMB, New Executive Office Building, 

725 17th Street NW, Washington, DC 

20502, Attn: Desk Officer for SAMHSA. 

Because of delays in receipt of mail, 

comments may also be sent to 202–395– 

6974 (fax). 

References 

1. U.S. Department of Justice (DOJ), Drug 

Enforcement Agency (DEA), Diversion 

Control Division. Controlled Substance 

Schedules. https://www.deadiversion.

usdoj.gov. Accessed June 9, 2021. 

2. Kim, V.J., Okano, C.K., Osborne, C.R., 

Frank, D.M., Meana, C.T., Castaneto, 

M.S, 2018. Can synthetic urine replace 

authentic urine to ‘‘beat’’ workplace drug 

testing? Drug Test. Anal., 11(2), 331–335. 

3. Quest Diagnostics, 2018. Workforce drug 

positivity at highest rate in a decade, 

finds analysis of more than 10 million 

drug test results. https://www.quest

diagnostics.com/dms/Documents/ 

Employer-Solutions/DTI-2018/2018- 

quest-diagnostics-drug-testing-index2018-report/2018QuestDiagnostics

DrugTestingIndex.pdf. Accessed October 

19, 2018. 

Summary 

These proposed revisions are 

intended to simplify changes to the 

authorized drug testing panel for 

Federal workplace drug testing 

programs, facilitate the identification of 

substituted specimens using biomarker 

testing, improve detection of illicit 

codeine and/or morphine use, and 

provide the Department with 

information on Federal agency drug test 

specimens that were reported as 

positive for a drug or drug metabolite by 

a laboratory and verified negative by the 

Medical Review Officer (MRO). There is 

no requirement for Federal agencies to 

use oral fluid as part of their drug 

testing program. A Federal agency may 

choose to use urine or oral fluid, or any 

combination of specimen types in 

accordance with the Mandatory 

Guidelines for each matrix in their 

program based on the agency’s mission, 

its employees’ duties, and the danger to 

the public health and safety or to 

national security that could result from 

an employee’s failure to carry out the 

duties of his or her position. The 

Department believes that the proposed 

revisions to the Mandatory Guidelines 

save costs and improve the effectiveness 

of Federal workplace drug testing 

programs. 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Proposed Rules 20531 

Dated: March 22, 2022 

Miriam E. Delphin-Rittmon, 

Assistant Secretary for Mental Health and 

Substance Use, Substance Abuse and Mental 

Health Services Administration. 

Approved: March 22, 2022. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

MANDATORY GUIDELINES FOR 

FEDERAL WORKPLACE DRUG 

TESTING PROGRAMS USING ORAL 

FLUID 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—Oral Fluid Specimens 

2.1 What type of specimen may be 

collected? 

2.2 Under what circumstances may an oral 

fluid specimen be collected? 

2.3 How is each oral fluid specimen 

collected? 

2.4 What volume of oral fluid is collected? 

2.5 How is the split oral fluid specimen 

collected? 

2.6 When may an entity or individual 

release an oral fluid specimen? 

Subpart C—Oral Fluid Specimen Tests 

3.1 Which tests are conducted on an oral 

fluid 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 undiluted (neat) 

oral fluid? 

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 an oral 

fluid specimen as adulterated? 

3.7 What criteria are used to report an oral 

fluid specimen as substituted? 

3.8 What criteria are used to report an 

invalid result for an oral fluid 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 a 

trainer for collectors? 

4.5 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 an oral fluid 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—Oral Fluid Specimen Collection 

Devices 

7.1 What is used to collect an oral fluid 

specimen? 

7.2 What are the requirements for an oral 

fluid collection device? 

7.3 What are the minimum performance 

requirements for a collection device? 

Subpart H—Oral Fluid Specimen Collection 

Procedure 

8.1 What privacy must the donor be given 

when providing an oral fluid specimen? 

8.2 What must the collector ensure at the 

collection site before starting an oral 

fluid specimen collection? 

8.3 What are the preliminary steps in the 

oral fluid specimen collection 

procedure? 

8.4 What steps does the collector take in the 

collection procedure before the donor 

provides an oral fluid specimen? 

8.5 What steps does the collector take 

during and after the oral fluid specimen 

collection procedure? 

8.6 What procedure is used when the donor 

states that they are unable to provide an 

oral fluid specimen? 

8.7 If the donor is unable to provide an oral 

fluid specimen, may another specimen 

type be collected for testing? 

8.8 How does the collector prepare the oral 

fluid specimens? 

8.9 How does the collector report a donor’s 

refusal to test? 

8.10 What are a federal agency’s 

responsibilities for a collection site? 

Subpart I—HHS Certification of 

Laboratories 

9.1 Who has the authority to certify 

laboratories to test oral fluid specimens 

for federal agencies? 

9.2 What is the process for a laboratory to 

become HHS-certified? 

9.3 What is the process for a laboratory to 

maintain HHS certification? 

9.4 What is the process when a laboratory 

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? 

9.7 What are the PT requirements for an 

HHS-certified oral fluid laboratory? 

9.8 What are the inspection requirements 

for an applicant laboratory? 

9.9 What are the maintenance inspection 

requirements for an HHS-certified 

laboratory? 

9.10 Who can inspect an HHS-certified 

laboratory and when may the inspection 

be conducted? 

9.11 What happens if an applicant 

laboratory does not satisfy the minimum 

requirements for either the PT program 

or the inspection program? 

9.12 What happens if an HHS-certified 

laboratory does not satisfy the minimum 

requirements for either the PT program 

or the inspection program? 

9.13 What factors are considered in 

determining whether revocation of a 

laboratory’s HHS certification is 

necessary? 

9.14 What factors are considered in 

determining whether to suspend a 

laboratory’s HHS certification? 

9.15 How does the Secretary notify an HHScertified laboratory that action is being 

taken against the laboratory? 

9.16 May a laboratory that had its HHS 

certification revoked be recertified to test 

federal agency specimens? 

9.17 Where is the list of HHS-certified 

laboratories 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? 

10.2 What are the requirements for blind 

samples? 

10.3 How is a blind sample submitted to an 

HHS-certified laboratory? 

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 are the requirements for an 

initial drug test? 

11.10 What must an HHS-certified 

laboratory do to validate an initial drug 

test? 


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11.11 What are the batch quality control 

requirements when conducting an initial 

drug test? 

11.12 What are the requirements for a 

confirmatory drug test? 

11.13 What must an HHS-certified 

laboratory do to validate a confirmatory 

drug test? 

11.14 What are the batch quality control 

requirements when conducting a 

confirmatory drug test? 

11.15 What are the analytical and quality 

control requirements for conducting 

specimen validity tests? 

11.16 What must an HHS-certified 

laboratory do to validate a specimen 

validity test? 

11.17 What are the requirements for an 

HHS-certified laboratory to report a test 

result? 

11.18 How long must an HHS-certified 

laboratory retain specimens? 

11.19 How long must an HHS-certified 

laboratory retain records? 

11.20 What statistical summary reports 

must an HHS-certified laboratory 

provide for oral fluid testing? 

11.21 What HHS-certified laboratory 

information is available to a federal 

agency? 

11.22 What HHS-certified laboratory 

information is available to a federal 

employee? 

11.23 What types of relationships are 

prohibited between an HHS-certified 

laboratory and an MRO? 

Subpart L—Instrumented Initial Test Facility 

(IITF) 

12.1 May an IITF test oral fluid specimens 

for a federal agency’s workplace drug 

testing program? 

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 an oral fluid 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 oral 

fluid for a drug test? 

13.7 What happens when an individual is 

unable to provide a sufficient amount of 

oral fluid 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? 

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

specimen? 

13.9 How does an MRO report a primary 

(A) specimen test result to an agency? 

13.10 What types of relationships are 

prohibited between an MRO and an 

HHS-certified laboratory? 

13.11 What reports must an MRO provide 

to the Secretary for oral fluid 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) oral fluid specimen when 

the primary (A) specimen was reported 

adulterated? 

14.4 How does an HHS-certified laboratory 

test a split (B) oral fluid 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) oral fluid 

specimen result from the second HHScertified 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 to report an oral fluid 

specimen as rejected for testing? 

15.2 What discrepancies require an HHScertified laboratory 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 to 

reject an oral fluid 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 Suspension/ 

Revocation Procedures 

16.1 When may the HHS certification of a 

laboratory 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 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 


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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 notice 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 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. 

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 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 Device. A product that is 

used to collect an oral fluid specimen 

and may include a buffer or diluent. 

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 

a 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. 

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, or 

combination electronic and paper 

format (hybrid). The form may also be 

used to report the test result to the 

Medical Review Officer. 

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 3.8 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. 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 


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or drug metabolite) can be accurately 

established. 

Lot. A number of units of an item 

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

oral fluid collection device) 

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. 

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. 

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 Oral 

Fluid). A collection in which two 

specimens (primary [A] and split [B]) 

are collected, concurrently or serially, 

and independently sealed in the 

presence of the donor; or a collection in 

which a single specimen is collected 

using a single collection device and is 

subdivided 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 urine specimen as 

substituted in UrMG Section 3.7. 

Undiluted (neat) oral fluid. An oral 

fluid specimen to which no other solid 

or liquid has been added. For example, 

see Section 2.4: a collection device that 

uses a diluent (or other component, 

process, or method that modifies the 

volume of the testable specimen) must 

collect at least 1 mL of undiluted (neat) 

oral fluid. 

Section 1.6 What is an agency required 

to do to protect employee records? 

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

CFR 24.101–24.104, all agency contracts 

with laboratories, 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 (e.g., 

oral fluid or another authorized 

specimen type) for any drug test 

required by these Guidelines or federal 

agency regulations; 

(4) Fail to provide a sufficient amount 

of oral fluid 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; 

(5) Fail or decline to participate in an 

alternate specimen collection (e.g., 

urine) as directed by the federal agency 

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

8.6); 

(6) 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; 

(7) Fail to cooperate with any part of 

the testing process (e.g., disrupt the 

collection process, fail to rinse the 

mouth or wash hands after being 

directed to do so by the collector, refuse 

to provide a split specimen); 

(8) Bring materials to the collection 

site for the purpose of adulterating, 

substituting, or diluting the specimen; 


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(9) Attempt to adulterate, substitute, 

or dilute the specimen; or 

(10) 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 8.9. Required action includes 

immediately notifying the federal 

agency’s designated representative by 

any means (e.g., telephone or secure 

facsimile [fax] machine) that ensures 

that the refusal notification is 

immediately received and, if a Federal 

CCF has been initiated, documenting 

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—Oral Fluid Specimens 

Section 2.1 What type of specimen 

may be collected? 

A federal agency may collect oral 

fluid 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 oral fluid 

must follow these Guidelines. 

Section 2.2 Under what circumstances 

may an oral fluid specimen be 

collected? 

A federal agency may collect an oral 

fluid 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 oral fluid 

specimen collected? 

Each oral fluid specimen is collected 

as a split specimen (i.e., collected either 

simultaneously or serially) as described 

in Sections 2.5 and 8.8. 

Section 2.4 What volume of oral fluid 

is collected? 

A volume of at least 1 mL of 

undiluted (neat) oral fluid for each oral 

fluid specimen (designated ‘‘Tube A’’ 

and ‘‘Tube B’’) is collected using a 

collection device. If the device does not 

include a diluent (or other component, 

process, or method that modifies the 

volume of the testable specimen), the A 

and B tubes must have a volume 

marking clearly noting a level of 1 mL. 

Section 2.5 How is the split oral fluid 

specimen collected? 

The collector collects at least 1 mL of 

undiluted (neat) oral fluid in a 

collection device designated as ‘‘A’’ 

(primary) and at least 1 mL of undiluted 

(neat) oral fluid in a collection device 

designated as ‘‘B’’ (split) either 

simultaneously or serially (i.e., using 

two devices or using one device and 

subdividing the specimen), as described 

in Section 8.8. 

Section 2.6 When may an entity or 

individual release an oral fluid 

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 13.8. 

Subpart C—Oral Fluid Specimen Tests 

Section 3.1 Which tests are conducted 

on an oral fluid specimen? 

A federal agency: 

(a) Must ensure that each specimen is 

tested for marijuana and cocaine 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) Is authorized upon a Medical 

Review Officer’s request to test an oral 

fluid specimen to determine specimen 

validity using, for example, a test for a 

specific adulterant; 

(d) Is authorized to test each specimen 

for one or more biomarkers as provided 

in the biomarker testing panel described 

under Section 3.4; and 

(e) 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, then additional 

testing may be performed. 

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 paragraph (a) of this 

section. 

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 


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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 

undiluted (neat) oral fluid? 

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/ 

drug-testing. 

This drug testing panel will remain in 

effect until the effective date of a new 

drug testing panel published in the 

Federal Register: 

Initial test analyte Initial test cutoff 1 Confirmatory test analyte 

Confirmatory 

test cutoff 

concentration 

Marijuana (THC) 2 ........................................................................... 4 ng/mL 3 THC ........................................... 2 ng/mL 

Cocaine/Benzoylecgonine ............................................................... 15 ng/mL Cocaine .....................................

Benzoylecgonine .......................

8 ng/mL 

8 ng/mL 

Codeine/Morphine ........................................................................... 30 ng/mL Codeine .....................................

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

15 ng/mL 

15 ng/mL 

Hydrocodone/Hydromorphone ........................................................ 30 ng/mL Hydrocodone .............................

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

15 ng/mL 

15 ng/mL 

Oxycodone/Oxymorphone .............................................................. 30 ng/mL Oxycodone ................................

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

15 ng/mL 

15 ng/mL 

6-Acetylmorphine ............................................................................ 4 ng/mL 3 6-Acetylmorphine ....................... 2 ng/mL 

Phencyclidine .................................................................................. 10 ng/mL Phencyclidine ............................ 10 ng/mL 

Amphetamine/Methamphetamine ................................................... 50 ng/mL Amphetamine ............................

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

25 ng/mL 

25 ng/mL 

MDMA4/MDA5 ................................................................................ 50 ng/mL MDMA ........................................

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

25 ng/mL 

25 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 (THC). 3Alternate technology (THC and 6–AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the 

target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6–AM). 4 Methylenedioxymethamphetamine (MDMA). 

5 Methylenedioxyamphetamine (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 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., 

specimen validity tests). An HHScertified 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 an oral fluid specimen as 

adulterated? 

An HHS-certified laboratory reports a 

primary (A) specimen as adulterated 

when the presence of an adulterant 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 an oral fluid specimen as 

substituted? 

An HHS-certified laboratory reports a 

primary (A) specimen as substituted 

when a biomarker is not detected or is 

present at a concentration inconsistent 

with that established for human oral 

fluid 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 an invalid result for an oral fluid 

specimen? 

An HHS-certified laboratory reports a 

primary (A) oral fluid specimen as an 

invalid result when: 

(a) Interference occurs on the initial 

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

valid immunoassay or alternate 

technology initial drug test results 

cannot be obtained); 

(b) Interference with the drug 

confirmatory assay occurs on two 

separate aliquots of the specimen and 


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the laboratory is unable to identify the 

interfering substance; 

(c) The physical appearance of the 

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

testing the specimen may damage the 

laboratory’s instruments; 

(d) The specimen has been tested and 

the appearances of the primary (A) and 

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

clearly different; or 

(e) A specimen validity test 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 oral fluid specimens in 

accordance with these Guidelines and 

the manufacturer’s procedures for the 

collection device. 

(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 

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 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 personal friend (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 use the 

specific oral fluid collection device. 

Training must include the following: 

(i) All steps necessary to complete an 

oral fluid 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 two uneventful collection 

scenarios, one insufficient specimen 

quantity 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 

tube 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 

paragraph (a) of this section. 

(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 a trainer for collectors? 

(a) Individuals are considered 

qualified trainers for collectors for a 

specific oral fluid collection device and 

may train others to collect oral fluid 

specimens using that collection device 

when they have completed the 

following: 

(1) Qualified as a trained collector and 

regularly conducted oral fluid drug test 

collections using that collection device 

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 4.5 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 an oral fluid 

specimen (e.g., an accident 

investigation), another site may be used 

for the collection, providing the 

collection is performed by a collector 

who has been trained to collect oral 

fluid specimens in accordance with 

these Guidelines and the manufacturer’s 

procedures for the collection device. 

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; 

(d) A restricted access area where 

only authorized personnel may be 

present during the collection; 


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(e) A restricted access area for the 

storage of collection supplies; and 

(f) The ability to store records 

securely. 

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 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. 

Section 5.6 What are the privacy 

requirements when collecting an oral 

fluid 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 

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 must 

handle and test the specimen as a 

federal agency specimen. 

(c) If the HHS-certified laboratory or 

MRO discovers that the collector used 

an incorrect form, the laboratory 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 reports a 

rejected for testing result to the MRO 

and the MRO cancels the test. The HHScertified laboratory 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—Oral Fluid Specimen 

Collection Devices 

Section 7.1 What is used to collect an 

oral fluid specimen? 

An FDA-cleared single-use collection 

device intended to collect an oral fluid 

specimen must be used. This collection 

device must maintain the integrity of 

such specimens during storage and 

transport so that the specimen 

contained therein can be tested in an 

HHS-certified laboratory for the 

presence of drugs or their metabolites. 

Section 7.2 What are the requirements 

for an oral fluid collection device? 

An oral fluid specimen collection 

device must provide: 

(a) An indicator that demonstrates the 

adequacy of the volume of oral fluid 

specimen collected; 

(b) One or two sealable, non-leaking 

tubes [depending on the device type, as 

described in Section 8.8(a)] that: 

(1) Maintain the integrity of the 

specimen during storage and transport 

so that the specimen contained therein 

can be tested in an HHS-certified 

laboratory for the presence of drugs or 

their metabolites, 

(2) are sufficiently transparent to 

enable a visual assessment of the 

contents (i.e., oral fluid, buffer/diluent, 

collection pad) for identification of 

abnormal physical characteristics 

without opening the tube, and 

(3) include the device lot expiration 

date on each specimen tube (i.e., the 

expiration date of the buffer/diluent or, 

for devices without a buffer/diluent, the 

earliest expiration date of any device 

component); 

(c) Components that ensure preanalytical drug and drug metabolite 

stability; and 

(d) Components that do not 

substantially affect the composition of 

drugs and/or drug metabolites in the 

oral fluid specimen. 

Section 7.3 What are the minimum 

performance requirements for a 

collection device? 

An oral fluid collection device must 

meet the following minimum 

performance requirements. 

(a) Reliable collection of a minimum 

of 1 mL of undiluted (neat) oral fluid; 

(b) If the collection device contains a 

diluent (or other component, process, or 

method that modifies the volume of the 

testable specimen): 

(1) The volume of oral fluid collected 

should be at least 1.0 mL ±10 percent, 

and 

(2) The volume of diluent in the 

device should be within ±2.5 percent of 

the diluent target volume; 

(c) Stability (recoverable 

concentrations ≥80 percent of the 

concentration at the time of collection) 

of the drugs and/or drug metabolites for 

five days at room temperature (64– 

77 °F/18–25 °C) and under the 

manufacturer’s intended shipping and 

storage conditions; and 

(d) Recover ≥80 percent (but no more 

than 120 percent) of drug and/or drug 

metabolite in the undiluted (neat) oral 

fluid at (or near) the initial test cutoff 

listed in the drug testing panel. 

Subpart H—Oral Fluid Specimen 

Collection Procedure 

Section 8.1 What privacy must the 

donor be given when providing an oral 

fluid specimen? 

The following privacy requirements 

apply when a donor is providing an oral 

fluid specimen: 

(a) Only authorized personnel and the 

donor may be present in the restricted 


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access area where the collection takes 

place. 

(b) The collector is not required to be 

the same gender as the donor. 

Section 8.2 What must the collector 

ensure at the collection site before 

starting an oral fluid specimen 

collection? 

The collector must deter the 

adulteration or substitution of an oral 

fluid specimen at the collection site. 

Section 8.3 What are the preliminary 

steps in the oral fluid specimen 

collection procedure? 

The collector must take the following 

steps before beginning an oral fluid 

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 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 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 oral fluid 

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. 

(f) If the donor will remain under the 

collector’s direct observation until the 

end of the collection, including the 10- 

minute wait period described in Section 

8.3(h), the collector proceeds to Section 

8.3(g). If the collector will not keep the 

donor under direct observation from 

this point until the end of the collection, 

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 or substitute 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 or substitute 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 8.9. 

(3) If an item that could be used to 

adulterate or substitute the specimen 

(e.g., common personal care products 

such as mouthwash, lozenges, capsules) 

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, the 

collector must keep the donor under 

direct observation until the end of the 

oral fluid collection. 

(g) The collector requests that the 

donor open the donor’s mouth, and the 

collector inspects the oral cavity to 

ensure that it is free of any items (e.g., 

candy, gum, food, tobacco) that could 

impede or interfere with the collection 

of an oral fluid specimen or items that 

could be used to adulterate, substitute, 

or dilute the specimen. 

(1) If an item is present that whose 

purpose is to adulterate or substitute the 

specimen (e.g., a commercial drug 

culture product or other item 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 8.9. 

(2) If an item is present that could 

impede or interfere with the collection 

of an oral fluid specimen (including 

abnormally colored saliva), or the donor 

claims to have ‘‘dry mouth,’’ the 

collector gives the donor water (e.g., up 

to 4 oz.) to rinse their mouth. The donor 

may drink the water. If the donor 

refuses to remove the item or refuses to 

rinse, this is a refusal to test. 

(3) If the donor claims that they have 

a medical condition that prevents 

opening their mouth for inspection, the 

collector follows the procedure in 

Section 8.6(b)(2). 

(h) The collector must initiate a 10- 

minute wait period prior to collecting 

the specimen. During these 10 minutes, 

the collector must: 

(1) Explain the basic collection 

procedure to the donor; 

(2) Provide the instructions for 

completing the Federal CCF for the 

donor’s review, and informs the donor 

that these instructions and the 

collection device-specific instructions 

are available upon request. 

(3) Answer any reasonable and 

appropriate questions the donor may 

have regarding the collection procedure; 

and 

(4) Inform the donor that they must 

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

area designated by the collector) during 

the wait period, and that failure to 

follow these instructions will be 

reported as a refusal to test. 

Section 8.4 What steps does the 

collector take in the collection 

procedure before the donor provides an 

oral fluid specimen? 

(a) The collector shall instruct the 

donor to wash and dry the donor’s 

hands under the collector’s observation, 

and to keep their hands within view and 

avoid touching items or surfaces after 

handwashing. If the donor refuses to 

wash their hands when instructed by 

the collector, this is a refusal to test. 

(b) The collector will provide or the 

donor may select the specimen 

collection device(s) to be used for the 

collection. The device(s) must be clean, 

unused, and wrapped/sealed in original 

packaging. See Section 8.8(a) for types 

of specimen collection devices used for 

oral fluid split specimen collections. 

(1) The collector will open the 

package in view of the donor. 

(2) Both the collector and the donor 

must keep the unwrapped collection 

devices in view at all times until each 

collection device containing the donor’s 

oral fluid specimen has been sealed and 

labeled. 

(c) The collector reviews with the 

donor the procedures required for a 

successful oral fluid specimen 

collection as stated in the 

manufacturer’s instructions for the 

specimen collection device. 

(d) 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., 

an attempt to prevent the device from 

collecting sufficient oral fluid; an 

attempt to bring into the collection site 

an adulterant or oral fluid substitute), 

the collector must report a refusal to test 

in accordance with Section 8.9. 


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Section 8.5 What steps does the 

collector take during and after the oral 

fluid specimen collection procedure? 

Integrity and Identity of the 

Specimen. The collector must take the 

following steps during and after the 

donor provides the oral fluid specimen: 

(a) The collector shall be present and 

maintain visual contact with the donor 

during the procedures outlined in this 

section. 

(1) Under the observation of the 

collector, the donor is responsible for 

positioning the specimen collection 

device for collection. The collector must 

ensure the collection is performed 

correctly and that the collection device 

is working properly. If there is a failure 

to collect the specimen, the collector 

must begin the process again, beginning 

with Step 8.4(b), using a new specimen 

collection device (for both A and B 

specimens) and notes the failed 

collection attempt on the Federal CCF. 

If the donor states that they are unable 

to provide an oral fluid specimen during 

the collection process or after multiple 

failures to collect the specimen, the 

collector follows the procedure in 

Section 8.6. 

(2) The donor and the collector must 

complete the collection in accordance 

with the manufacturer instructions for 

the collection device. 

(3) The collector must inspect the 

specimen to determine if there is any 

sign indicating that the specimen may 

not be a valid oral fluid specimen (e.g., 

unusual color, presence of foreign 

objects or material), documents any 

unusual findings on the Federal CCF, 

and takes action (e.g., recollection) to 

obtain an acceptable specimen. 

(b) If the donor fails to remain present 

through the completion of the 

collection, fails to follow the 

instructions for the collection device, 

refuses to begin the collection process 

after a failure to collect the specimen as 

required in step (a)(1) above, refuses to 

provide a split specimen as instructed 

by the collector, or refuses to provide an 

alternate specimen as authorized in 

Section 8.6, the collector stops the 

collection and reports the refusal to test 

in accordance with Section 8.9. 

Section 8.6 What procedure is used 

when the donor states that they are 

unable to provide an oral fluid 

specimen? 

(a) If the donor states that they are 

unable to provide an oral fluid 

specimen during the collection process, 

the collector requests that the donor 

follow the collector instructions and 

attempt to provide an oral fluid 

specimen. 

(b) The donor demonstrates their 

inability to provide a specimen when, 

after 15 minutes of using the collection 

device, there is insufficient volume or 

no oral fluid collected using the device. 

(1) If the donor states that they could 

provide a specimen after drinking some 

fluids, the collector gives the donor a 

drink (up to 8 ounces) and waits an 

additional 10 minutes before beginning 

the specimen collection (a period of 1 

hour must be provided or until the 

donor has provided a sufficient oral 

fluid specimen). If the donor simply 

needs more time before attempting to 

provide an oral fluid specimen, the 

donor may choose not to drink any 

fluids during the 1 hour wait time. The 

collector must inform the donor that the 

donor must remain at the collection site 

(i.e., in an area designated by the 

collector) during the wait period. 

(2) If the donor states that they are 

unable to provide an oral fluid 

specimen, the collector records the 

reason for not collecting an oral fluid 

specimen on the Federal CCF, notifies 

the federal agency’s designated 

representative for authorization of an 

alternate specimen to be collected, 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 alternative specimen. 

Section 8.7 If the donor is unable to 

provide an oral fluid 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 oral fluid specimens? 

(a) All federal agency collections are 

to be split specimen collections. An oral 

fluid split specimen collection may be: 

(1) Two specimens collected 

simultaneously with two separate 

collection devices; 

(2) Two specimens collected serially 

with two separate collection devices. 

The donor is not allowed to drink or 

rinse their mouth between the two 

collections. Collection of the second 

specimen must begin within two 

minutes after the completion of the first 

collection and recorded on the Federal 

CCF; 

(3) Two specimens collected 

simultaneously using a single collection 

device that directs the oral fluid into 

two separate collection tubes; or 

(4) A single specimen collected using 

a single collection device, that is 

subsequently subdivided into two 

specimens. 

(b) A volume of at least 1 mL of 

undiluted (neat) oral fluid is collected 

for the specimen designated as ‘‘Tube 

A’’ and a volume of at least 1 mL of 

undiluted (neat) oral fluid is collected 

for the specimen designated as ‘‘Tube 

B’’. 

(c) In the presence of the donor, the 

collector places a tamper-evident label/ 

seal from the Federal CCF over the cap 

of each specimen tube. 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 tube. 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 

the information required on the Federal 

CCF is provided. 

(f) The collector asks the donor to 

read and sign a statement on the Federal 

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 

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

within 24 hours or during the next 

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

the Tube A oral fluid specimen. 

(i) If the specimen and Federal CCF 

are not immediately transported to an 

HHS-certified laboratory, they must 

remain under direct control of the 

collector or be appropriately secured 

under proper specimen storage 

conditions until transported. 

Section 8.9 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 oral fluid 

specimen collected and reports the 

refusal to test by: 


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(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 on 

the Federal CCF, and 

(c) Sending all copies of the Federal 

CCF to the federal agency’s designated 

representative. 

Section 8.10 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. 

(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) 

and take appropriate action which may 

include a collection site self-assessment 

(i.e., using the Collection Site Checklist 

for the Collection of Oral Fluid 

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 

Section 9.1 Who has the authority to 

certify laboratories to test oral fluid 

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, including 

suspending the use of certain analytical 

procedures when necessary to protect 

the integrity of the testing process; 

ordering any HHS-certified laboratory to 

undertake corrective actions to respond 

to material deficiencies identified by an 

inspection or through performance 

testing; ordering any HHS-certified 

laboratory to send specimens or 

specimen aliquots to another HHScertified 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 is prohibited from 

stating or implying that it is certified by 

HHS under these Guidelines to test oral 

fluid specimens for federal agencies 

unless it holds such certification. 

Section 9.2 What is the process for a 

laboratory to become HHS-certified? 

(a) A laboratory seeking HHS 

certification must: 

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

applicant laboratory 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 to maintain HHS 

certification? 

(a) To maintain HHS certification, a 

laboratory 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 does not maintain its HHS 

certification? 

(a) A laboratory 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 11.18, 11.19, and 

14.8; 

(3) Ensure access to federally 

regulated specimens and records in 

accordance with Sections 11.21 and 

11.22 and Subpart P; and 

(4) Follow the HHS suspension and 

revocation procedures when imposed by 

the Secretary, follow the HHS 

procedures in Subpart P that will be 

used for all actions associated with the 

suspension and/or revocation of HHScertification. 

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 may be sent to the 

laboratory as undiluted (neat) oral fluid. 

The PT samples 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 9.5(a)(1)(i) 

and 9.5(a)(1)(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 or invalid result. 

(3) A negative PT sample will not 

contain a measurable amount of a target 

analyte. 

(b) The laboratory 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? 

(a) An applicant laboratory that seeks 

certification under these Guidelines 

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; 


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(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, 

must 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 specified criteria; and 

(10) Do not report any PT sample as 

adulterated with a compound that is not 

present in the sample 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 

disqualification. 

Section 9.7 What are the PT 

requirements for an HHS-certified oral 

fluid laboratory? 

(a) A laboratory certified under these 

Guidelines 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 

mean; 

(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 

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 specified criteria; and 

(10) Do not report any PT sample as 

adulterated with a compound that is not 

present in the sample 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 inspection 

requirements for an applicant 

laboratory? 

(a) An applicant laboratory is 

inspected by a team of two inspectors. 

(b) Each inspector conducts an 

independent review and evaluation of 

all aspects of the laboratory’s testing 

procedures and facilities using an 

inspection checklist. 

Section 9.9 What are the maintenance 

inspection requirements for an HHScertified laboratory? 

(a) An HHS-certified laboratory must 

undergo an inspection 3 months after 

becoming certified and at least every 6 

months thereafter. 

(b) An HHS-certified laboratory is 

inspected by one 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 

procedures, records, and facilities using 

guidance provided by the Secretary. 

(d) To remain certified, an HHScertified laboratory must continue to 

satisfy the minimum requirements as 

stated in these Guidelines. 

Section 9.10 Who can inspect an HHScertified laboratory 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; 

(2) Has read and thoroughly 

understands the policies and 

requirements contained in these 

Guidelines and in other guidance 

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. 

(b) The Secretary or a federal agency 

may conduct an inspection at any time. 

Section 9.11 What happens if an 

applicant laboratory does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

If an applicant laboratory fails to 

satisfy the requirements established for 

the initial certification process, the 

laboratory must start the certification 

process from the beginning. 

Section 9.12 What happens if an HHScertified laboratory does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

(a) If an HHS-certified laboratory fails 

to satisfy the minimum requirements for 

certification, the laboratory 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 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 may 

be required to undergo a special 

inspection or to test additional PT 

samples to address deficiencies. 

(d) If an HHS-certified laboratory’s 

certification is revoked or suspended in 


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accordance with the process described 

in Subpart P, the laboratory is not 

permitted to test federally regulated 

specimens until the suspension is lifted 

or the laboratory has successfully 

completed the certification 

requirements as a new applicant 

laboratory. 

Section 9.13 What factors are 

considered in determining whether 

revocation of a laboratory’s HHS 

certification is necessary? 

(a) The Secretary shall revoke 

certification of an HHS-certified 

laboratory in accordance with these 

Guidelines if the Secretary determines 

that revocation is necessary to ensure 

fully reliable and accurate drug 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 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 by a federal agency 

using the laboratory’s services; 

(4) Conviction for any criminal 

offense committed as an incident to 

operation of the HHS-certified 

laboratory; or 

(5) Any other cause that materially 

affects the ability of the HHS-certified 

laboratory 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 9.14 What factors are 

considered in determining whether to 

suspend a laboratory’s HHS 

certification? 

(a) The Secretary may immediately 

suspend (either partially or fully) a 

laboratory’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 9.15 How does the Secretary 

notify an HHS-certified laboratory that 

action is being taken against the 

laboratory? 

(a) When a laboratory’s HHS 

certification is suspended or the 

Secretary seeks to revoke HHS 

certification, the Secretary shall 

immediately serve the HHS-certified 

laboratory with written notice of the 

suspension or proposed revocation by 

fax, mail, personal service, or registered 

or certified mail, return receipt 

requested. This notification 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 notification shall state 

that the laboratory 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 received 

the notification, or if expedited review 

is requested, within 3 days of the date 

the laboratory received the notification. 

Subpart P 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 

notification 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 that has its certification 

revoked or suspended under Section 

9.13 or Section 9.14, respectively, and 

the name of any HHS-certified 

laboratory that has its suspension lifted. 

The Secretary shall provide to any 

member of the public upon request the 

written notification provided to a 

laboratory 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. 

Section 9.16 May a laboratory that had 

its HHS certification revoked be 

recertified to test federal agency 

specimens? 

Following revocation, a laboratory 

may apply for recertification. Unless 

otherwise provided by the Secretary in 

the notification of revocation under 

Section 9.15 or the reviewing official’s 

decision under Section 16.9(e) or 

16.14(a), a laboratory which has had its 

certification revoked may reapply for 

HHS certification as an applicant 

laboratory. 

Section 9.17 Where is the list of HHScertified laboratories published? 

(a) The list of HHS-certified 

laboratories is published monthly in the 

Federal Register. This notification is 

also available on the internet at https:// 

www.samhsa.gov/workplace. 

(b) An applicant laboratory 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? 

(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 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 and 25 

percent must be positive for one or more 

drugs. 

Section 10.2 What are the 

requirements for blind samples? 

(a) Drug positive blind samples must 

be validated by the supplier in the 

selected manufacturer’s collection 

device as to their content using 

appropriate initial and confirmatory 

tests. 

(1) Drug positive blind samples must 

be fortified with 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 in the selected 

manufacturer’s collection device as 

negative using appropriate initial and 

confirmatory tests. 


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(c) 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, 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? 

(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 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 reports 

a result for a blind sample that is 

inconsistent with the expected result 

(e.g., a laboratory 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 and attempt to determine if 

the laboratory 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; 

(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 

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 


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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. 

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 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 11.11. 

Section 11.10 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); 


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(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 11.11 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 11.12 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 

an oral fluid specimen when identifying 

and quantifying drugs or their 

metabolites. 

Section 11.13 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 11.14 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 11.15 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; and 

(c) Controls must be analyzed 

concurrently with specimens. 

Section 11.16 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. 

Section 11.17 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. 

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 

testing, and the specimen does not meet 

invalid criteria as described in items 

(g)(1) through (g)(5) below. 

(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) oral fluid specimen 

is reported adulterated when the 

presence of an adulterant is verified 

using an initial test on the first aliquot 

and a different confirmatory test on the 

second aliquot. 

(e) A primary (A) oral fluid specimen 

is reported substituted when a 

biomarker is not present or is present at 

a concentration inconsistent with that 

established for human oral fluid. 

(f) For a specimen that has an invalid 

result for one of the reasons stated in 

items (g)(1) through (g)(5) below, 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. 

(g) A primary (A) oral fluid specimen 

is reported as an invalid result when: 

(1) Interference occurs on the initial 

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

valid initial drug test results cannot be 

obtained); 

(2) Interference with the confirmatory 

drug test occurs on at least two separate 

aliquots of the specimen and the HHScertified laboratory is unable to identify 

the interfering substance; 

(3) The physical appearance of the 

specimen is such that testing the 

specimen may damage the laboratory’s 

instruments; 

(4) The physical appearances of the A 

and B specimens are clearly different 

(note: A is tested); or 

(5) A specimen validity test on two 

separate aliquots of the specimen 

indicates that the specimen is not valid 

for testing. 

(h) 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. 


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(i) An HHS-certified laboratory must 

report all positive, adulterated, 

substituted, and invalid test results for 

an oral fluid specimen. For example, a 

specimen can be positive for a specific 

drug and adulterated. 

(j) An HHS-certified laboratory must 

report the confirmatory concentration of 

each drug or drug metabolite reported 

for a positive result. 

(k) An HHS-certified laboratory must 

report numerical values of the specimen 

validity test results that support a 

specimen that is reported adulterated, 

substituted, or invalid (as appropriate). 

(l) An HHS-certified laboratory must 

report results using the HHS-specified 

nomenclature published with the drug 

and biomarker testing panels. 

(m) 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. 

(n) HHS-certified laboratories may 

transmit test results to the MRO by 

various electronic means (e.g., 

teleprinter, fax, or 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. 

(o) 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. 

(p) 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 11.18 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 specimens must be kept 

in secured storage in accordance with 

the collection device manufacturer’s 

specifications (i.e., frozen at ¥20 °C or 

less, or refrigerated), 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. 

Section 11.19 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 11.21) 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 11.20 What statistical 

summary reports must an HHS-certified 

laboratory provide for oral fluid 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; 

(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 

(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 11.21 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, if applicable) 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 


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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 11.22 What HHS-certified 

laboratory information is available to a 

federal employee? 

A federal employee who is the subject 

of a workplace drug test may submit a 

written request through the MRO and/ 

or the federal agency requesting copies 

of any records relating to the employee’s 

drug test results or a documentation 

package as described in Section 11.21(b) 

and any relevant certification, review, or 

revocation of certification records. 

Federal 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 11.23 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. 

Subpart L—Instrumented Initial Test 

Facility (IITF) 

Section 12.1 May an IITF test oral 

fluid specimens for a federal agency’s 

workplace drug testing program? 

No, only HHS-certified laboratories 

are authorized to test oral fluid 

specimens for federal agency workplace 

drug testing programs in accordance 

with these Guidelines. 

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; 

(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/drugtesting. 

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 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 

11.17(f) 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. 


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(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 an oral fluid specimen’s 

test results? 

(a) When the HHS-certified laboratory 

reports a negative result for the primary 

(A) specimen, the MRO reports a 

negative result to the agency. 

(b) When the HHS-certified laboratory 

reports multiple results for the primary 

(A) specimen, as the MRO, you must 

follow the verification procedures 

described in 13.5(c) through (f) and: 

(1) Report 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, do not report the 

verified invalid result to the federal 

agency at this time. The MRO takes the 

action described in Section 13.5(e) for 

the verified invalid result(s) for the 

primary (A) specimen only when: 

(i) The MRO verifies the laboratoryreported positive, adulterated, or 

substituted result as negative based on 

a legitimate medical explanation as 

described in 13.5(c)(2) and 13.5(d)(1), or 

based on codeine and/or morphine 

concentrations less than 150 ng/mL as 

described in 13.5(c)(3)(i); or 

(ii) The split (B) specimen is tested 

and reported as a failure to reconfirm as 

described in Section 14.6(m). 

(c) 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 agency. 

(2) If the donor provides 

documentation (e.g., a valid 

prescription) to support a legitimate 

medical explanation for the positive 

result, the MRO reports the test result as 

negative to the agency. 

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

exposure to secondhand 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) is not a legitimate 

medical explanation for a positive drug 

test result. See exceptions for positive 

codeine and morphine results in item 3 

below. 

(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, for all 

drugs except codeine and/or morphine 

as follows: 

(i) For codeine and/or morphine less 

than 150 ng/mL, the MRO must report 

the result as negative to the agency, 

unless the donor admits unauthorized 

use of the drug(s) that caused the 

positive result as described in item 

(c)(1) above. 

(ii) For codeine and/or morphine 

equal to or greater than 150 ng/mL and 

no legitimate medical explanation, the 

MRO shall report a positive result to the 

agency. Consumption of food products 

must not be considered a legitimate 

medical explanation for the donor 

having morphine or codeine at or above 

this concentration. 

(d) When the HHS-certified laboratory 

reports an adulterated or substituted 

result for the primary (A) oral fluid 

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 oral fluid 

specimen was adulterated or 

substituted. 

(e) When the HHS-certified laboratory 

reports an invalid result for the primary 

(A) oral fluid specimen, the MRO must 

contact the donor to determine if there 

is a legitimate explanation for the 

invalid result. 

(1) If the donor provides a legitimate 

explanation (e.g., a prescription 

medication), 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, the MRO 

reports a test cancelled result with the 

reason for the invalid result and directs 

the federal agency to immediately 

collect another specimen from the 

donor. 

(i) If the second specimen collected 

provides a valid result, the MRO follows 

the procedures in 13.5(a) through (d). 

(ii) If the second specimen collected 

provides an invalid result, the MRO 

reports this specimen as test cancelled 

and recommends that the agency collect 

another authorized specimen type (e.g., 

urine). 

(f) When the HHS-certified laboratory 

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. 

13.6 What action does the MRO take 

when the collector reports that the 

donor did not provide a sufficient 

amount of oral fluid for a drug test? 

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

urine) was collected as authorized by 

the federal agency, the MRO reviews 

and reports the test result in accordance 

with the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using the alternative 

specimen. 

(b) When the federal agency did not 

authorize the collection of an alternative 

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. 

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 

to correction or cure for an extended 

period of time. 

(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 

oral fluid to complete the test; 


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(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 

paragraph (b)(3) of this section 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 

paragraph (b)(1) of this section has, or 

with a high degree of probability could 

have, precluded the employee from 

providing a sufficient amount of oral 

fluid, but is not a permanent or longterm 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 paragraph (b)(1) 

of this section has, or with a high degree 

of probability could have, precluded the 

employee from providing a sufficient 

amount of oral fluid and is highly likely 

to prevent the employee from providing 

a sufficient amount of oral fluid 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., urine) 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 

oral fluid. 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 

paragraph (b)(3)(i) of this section, the 

agency takes no further action with 

respect to the donor. When a test is 

canceled as provided in paragraph 

(b)(3)(ii) of this section, 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. 

13.7 What happens when an 

individual is unable to provide a 

sufficient amount of oral fluid 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? 

(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 alternative 

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 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 oral fluid 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., urine) 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 oral fluid 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 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) 

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 13.9 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., teleprinter, fax, or 

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. 


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Section 13.10 What types of 

relationships are prohibited between an 

MRO and an HHS-certified laboratory? 

An MRO must not be an employee, 

agent of, or have any financial interest 

in an HHS-certified laboratory 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 have any agreement with 

the HHS-certified laboratory that may be 

construed as a potential conflict of 

interest. 

Section 13.11 What reports must an 

MRO provide to the Secretary for oral 

fluid 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 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 sent 

to a federal agency available 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 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 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 13.9 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) 

specimen be tested? 

(a) The donor may request, verbally or 

in writing, through the MRO that the 

split (B) specimen be tested at a 

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

oral fluid 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) oral fluid specimen 

cannot be tested by a second HHScertified laboratory (e.g., insufficient 

specimen, lost in transit, split not 

available, no second HHS-certified 

laboratory available to perform the test), 

the MRO reports to the federal agency 

that the test must be cancelled and the 

reason for the cancellation. The MRO 

directs the federal agency to ensure the 

immediate recollection of another oral 

fluid specimen from the donor, with no 

notification 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 oral fluid 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. 

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

fluid specimen when the primary (A) 

specimen was reported adulterated? 

(a) The HHS-certified 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) oral 

fluid specimen when the primary (A) 

specimen was reported substituted? 

(a) The HHS-certified laboratory must 

test for the biomarker using its 

confirmatory test (i.e., using the 

confirmatory test analytes and cutoffs 

listed in the biomarker testing panel). 

(b) The second HHS-certified 

laboratory may only conduct the 

confirmatory biomarker 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. 


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Section 14.6 What action(s) does an 

MRO take after receiving the split (B) 

oral fluid 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) oral fluid 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 that Laboratory A test 

the primary (A) specimen using its 

confirmatory test for the biomarker. 

(1) 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. 

(2) 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 

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 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. 

(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 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 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 


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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). 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, 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). 

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., teleprinter, fax, or 

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. 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 to 

report an oral fluid specimen as rejected 

for testing? 

The following discrepancies are 

considered to be fatal flaws. The HHScertified laboratory 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; 

(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 primary (A) specimen was 

collected using an expired device (i.e., 

the device expiration date precedes the 

collection date) and the split (B) 

specimen cannot be re-designated as the 

primary (A) specimen; 

(d) The collector’s printed name and 

signature are omitted on the Federal 

CCF; 

(e) There is an insufficient amount of 

specimen for analysis in the primary (A) 

specimen unless the split (B) specimen 

can be re-designated as the primary (A) 

specimen; 

(f) 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; 

(g) The specimen was received at the 

HHS-certified laboratory without a CCF; 

(h) The CCF was received at the HHScertified laboratory without a specimen; 

(i) The collector performed two 

separate collections using one CCF; or 

(j) The HHS-certified laboratory 

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 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 must attempt to recover the 

collector’s signature before reporting the 

test result. If the collector can provide 

a memorandum for record recovering 

the signature, the HHS-certified 

laboratory may report the test result for 

the specimen. If, after holding the 

specimen for at least 5 business days, 

the HHS-certified laboratory cannot 

recover the collector’s signature, the 

laboratory 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 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 specimen for at least 5 

business days, the HHS-certified 

laboratory cannot obtain a 

memorandum for record from the 

collector, the laboratory 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 to reject an oral 

fluid 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 should not cause an HHScertified laboratory to reject an oral fluid 

specimen or cause an MRO to cancel a 

test: 

(1) An incorrect laboratory name and 

address appearing at the top of the form; 


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(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) The specimen type box (Oral 

Fluid) is not marked (i.e., by the 

collector or laboratory); 

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

(12) The ‘‘each device within 

expiration date’’ box is not marked; 

(13) The collection site address is 

missing; 

(14) The collector’s printed name is 

missing but the collector’s signature is 

properly recorded; 

(15) The time of collection is not 

indicated; 

(16) The date of collection is not 

indicated; 

(17) Incorrect name of delivery 

service; 

(18) 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 

(19) The donor’s name inadvertently 

appears on the HHS-certified laboratory 

copy of the Federal CCF or on the 

tamper-evident labels used to seal the 

specimens. 

(b) The following omissions and 

discrepancies on the Federal CCF that 

are made at the HHS-certified laboratory 

should not cause an MRO to cancel a 

test: 

(1) The testing laboratory fails to 

indicate the correct name and address in 

the results section when a different 

laboratory 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 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 or HHScertified laboratory (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 does not 

contain all the data elements required 

for the HHS standard laboratory 

electronic report for a specimen being 

reported drug positive, adulterated, 

invalid result, or substituted. 

(b) If error (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 error (a)(2) occurs, the MRO 

must obtain a statement from the 

certifying scientist that they 

inadvertently 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 error (a)(3) occurs, the MRO 

must contact the HHS-certified 

laboratory. If, after at least 5 business 

days, the laboratory does not retransmit 

a corrected electronic report, the MRO 

must cancel the test. 

Subpart P—Laboratory Suspension/ 

Revocation Procedures 

Section 16.1 When may the HHS 

certification of a laboratory be 

suspended? 

These procedures apply when: 

(a) The Secretary has notified an HHScertified laboratory 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 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 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 

notification 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 notification 

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. 


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(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 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. 

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 


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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 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 received notification 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 

Sections 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, 

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 notification 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 notification 

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 Notification. If the 

suspension and proposed revocation are 


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upheld, the revocation will become 

effective immediately and the public 

will be notified by publication of a 

notification 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 notification 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. 2022–06884 Filed 4–6–22; 8:45 am] 

BILLING CODE 4150–28–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2