Mandatory Guidelines for Federal Workplace Drug Testing Programs; Notice DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUMMARY: The Department of Health and Human Services (HHS) revises some

of the scientific and technical guidelines for Federal drug testing

programs and revises certain standards for certification of

laboratories engaged in urine drug testing for Federal agencies.

EFFECTIVE DATE: September 1, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. Donna M. Bush, Chief, Drug Testing

Section, Division of Workplace Programs, Substance Abuse and Mental

Health Services Administration (SAMHSA), room 9A-53, 5600 Fishers Lane,

Rockville, Maryland 20857, tel. (301) 443-6014.

SUPPLEMENTARY INFORMATION: The Department is revising the guidelines

entitled ``Mandatory Guidelines for Federal Workplace Drug Testing

Programs,'' (Mandatory Guidelines) which were initially published in

the Federal Register on April 11, 1988 (53 FR 11979). These Mandatory

Guidelines and the revisions are developed in accordance with Executive

Order No. 12564 dated September 15, 1986, and section 503 of Public Law

100-71, 5 U.S.C. section 7301 note, the Supplemental Appropriations Act

for fiscal year 1987 dated July 11, 1987. The revisions to the

Mandatory Guidelines incorporate changes based on the comments

submitted and the Department's first 5 years of experience in

implementing and administering these Guidelines.

BACKGROUND AND SUMMARY OF PUBLIC COMMENTS AND POLICIES OF THE REVISED

GUIDELINES

A. Proposed Revised Mandatory Guidelines

The basic purpose of the Mandatory Guidelines is to establish

scientific and technical guidelines for Federal agencies' workplace

drug testing programs and to establish a certification program for

laboratories engaged in urine drug testing for Federal agencies. The

proposed revisions published in the Federal Register on January 25,

1993 (58 FR 6062), retained the basic requirements in the Mandatory

Guidelines published in the Federal Register on April 11, 1988, but as

indicated above refined some requirements in order to incorporate

changes based on the Department's first 5 years of experience in

implementing and administering these Guidelines.

The major changes proposed in the notice published in the Federal

Register on January 25, 1993, are summarized here to facilitate the

discussion of the comments received during the public comment period.

The Department proposed reducing the requirement to collect 60 mL

of urine at the collection site to 30 mL. This change was proposed

because many times donors have difficulty in providing the 60 mL of

urine. In addition, 30 mL is adequate to complete the required testing

and satisfy other program requirements.

The Department proposed to revise the specimen collection procedure

to allow Federal agencies to use an optional ``split specimen''

collection procedure. Several Federal agencies have been granted

waivers to use split specimen collection procedures during the past 5

years. Establishing a ``split specimen'' procedure will ensure that

each Federal agency will be using the same procedure. The Department

believes that appropriate guidance must be provided regarding the

minimum acceptable volumes for the split specimens, measuring

temperature before a single donor specimen is transferred into two

separate specimen bottles, sending both split specimen bottles to the

laboratory at the same time to ensure that they are subject to the same

shipping and storage conditions, and specifying the procedures for

testing Bottle B when the Bottle A specimen is reported positive.

The Department proposed to revise the collection procedure to allow

Federal agencies to use an individual of the same gender, other than a

collection site employee, to observe the collection of a specimen

whenever there is reason to believe the individual may have altered or

substituted the specimen. This change is based on the understanding

that it is not always possible to have a collection site employee of

the same gender observe the collection.

The Department proposed a change to allow a laboratory to use a

certifying scientist who is only certified to review initial drug tests

which are negative. This could assist in reducing the cost of testing

without compromising the reliability of drug testing.

The Department proposed that the initial test level for marijuana

metabolites be reduced from 100 ng/mL to 50 ng/mL. This change reflects

advances in technology of immunoassay tests for marijuana metabolites.

The Department proposed to allow laboratories to use multiple

immunoassay tests for the same drug or drug class. This would allow

laboratories to use an initial test and then forward all presumptive

positives for a second test by a different immunoassay technique to

minimize possible presumptive positives due to the presence of

structural analogues in the specimen. In addition, this policy would

allow a laboratory to use a different immunoassay for specimens that

may be untestable with one immunoassay.

The Department proposed that in order to report a specimen positive

for only methamphetamine, the specimen must also contain the metabolite

amphetamine at a concentration equal to or greater than 200 ng/mL by

the confirmatory test. This proposed requirement would ensure that high

concentrations of sympathomimetic amines available in over-the-counter

and prescription medications will not be misidentified as

methamphetamine.

The Department proposed reducing the number of blind samples a

Federal agency must submit each quarter to its contracting laboratory

from 10% of all samples to a minimum of 3% (with a maximum of 100 blind

samples). This proposed change may significantly reduce the costs

associated with maintaining a blind sample program without affecting

the Federal agency's ability to monitor a laboratory's performance.

The performance testing sample portion of the laboratory

certification program was proposed to be changed by reducing the

performance testing (PT) challenges for certified laboratories from 6

cycles per year to 4 cycles per year. Experience in this and other

performance testing programs indicates that 4 cycles per year is

sufficient to assess a laboratory's ability to test and report results

for performance testing samples.

The Department proposed restricting the types of arrangements that

can exist between the Medical Review Officer (MRO) and the laboratory

to ensure that a conflict of interest does not exist. The restrictions

would require that the agency's MRO not be an employee or an agent of,

or have any financial interest in, the laboratory for which the MRO is

reviewing drug testing results. Similarly, the laboratory would be

prohibited from entering into any agreement with an MRO that could be

construed as a conflict of interest.

A new subpart D was proposed which provides detailed procedures for

the internal review of a suspension or proposed revocation of a

laboratory's certification to perform drug testing. These procedures

will ensure and provide a timely and fair review of all suspensions or

proposed revocations.

The Department proposed that the written notice of the suspension

which is sent to the laboratory, as well as the reviewing official's

written decision upholding or denying suspension or proposed revocation

under the review procedures in subpart D, would be made available to

the public upon request. This provision ensures that the public has

access to the documents containing the basis for HHS's actions.

B. Public Comments and the Department's Responses

The Department received 73 public comments on the proposed changes

from Federal agencies, individuals, organizations, and companies. About

50% of these supported all or some of the proposed changes. All written

comments were reviewed and taken into consideration in the preparation

of the revised Mandatory Guidelines. The substantive concerns raised in

the public comments and the Department's responses to the comments are

set out below. Similar comments are considered together.

1. Definitions

A number of commenters expressed concerns with the definitions in

section 1.2. It was suggested that the definition for chain of custody

indicate that couriers do not need to document chain of custody while

the specimens are in transit to the laboratory. The Department agrees

that the Mandatory Guidelines should be clarified to address that

issue. Specimens are sealed in packages and any tampering with a sealed

specimen would be noticed by the laboratory and documented on the

specimen chain of custody. In addition, as a practical matter,

couriers, express couriers, and postal service personnel do not have

access to the specimen chain of custody form since the form is inside

the sealed package. Section 2.2(i) of the Mandatory Guidelines that

discusses the transportation of a specimen to a laboratory has been

revised to clarify this point.

One commenter recommended that the definitions in the Guidelines

conform to the definitions established by the National Committee for

Clinical Laboratory Standards (NCCLS) since the proposed definitions

may be in conflict with the efforts of that nonprofit, educational

organization. The Department fully supports the efforts of this

committee to develop standard definitions since a common understanding

of definitions is essential for maintaining a high level of performance

within laboratory testing programs. The Department has revised the

definitions in section 1.2 to ensure that they are consistent with

those proposed currently by NCCLS. The Department has changed the

proposed definitions for calibrator, control, and standard as well as

included new definitions for donor, specimen, sample, and quality

control sample. The Department also made appropriate changes in other

sections of the Guidelines to ensure that the terms used were

consistent with these new definitions. The Department notes, however,

that these changes are not substantive, but rather are technical in

nature to clarify the definitions. The Department believes these

changes will eliminate the confusion expressed by several other

commenters regarding the use of these terms in other sections of the

Guidelines.

One commenter believes the proposed definition for the certifying

scientist should specifically state that the individual understands

chain of custody. The Department intended that the definition of

certifying scientist include that the individual have a thorough

understanding of chain of custody, since it was proposed that such

individual have ``training and experience in the theory and practice of

all methods and procedures used in the laboratory.'' See section 1.2.

However, in order to prevent any confusion, the definition has been

changed to clarify this issue.

One commenter suggested that the Secretary require a certifying

scientist to possess at least a masters degree, so they would be equal

to experts presented by an employee who is contesting the result in

court or in an administrative proceeding. Based on the Department's

experience, there are numerous highly qualified individuals serving as

certifying scientists who possess bachelors' degrees, and who have the

expertise to testify as to the records they have certified. These

certifying scientists do not need to be qualified as experts in

litigation, as the defense may qualify someone else in the laboratory

or outside the laboratory to perform this function, if necessary.

Further, the Department believes that requiring higher educational

requirements would place an unnecessary burden on the laboratories, as

well as eliminate many qualified individuals from serving as certifying

scientists.

One commenter believes the requirement to use an Office of

Management and Budget (OMB) approved specimen chain of custody form

requires the laboratories to use OMB approved laboratory chain of

custody forms. This interpretation is incorrect. The Department

proposed that such forms be used only for specimen chain of custody

forms, not laboratory chain of custody forms. The Department believes

that standard specimen chain of custody forms are important to ensure

that collection sites have a consistent form so as to reduce any errors

or incomplete documentation when filling out the forms.

One commenter noted that the Department's proposed definition of an

immunoassay test is ambiguous and does not support the policy that

allows using a second immunoassay test for specimens that are

presumptively positive for amphetamines. Specifically, the term

``initial test'' was proposed to be defined as ``[a]n immunoassay test

to eliminate ``negative'' urine specimens from further consideration

and to identify the class of drugs that requires confirmation.'' The

Department agrees with the commenter that the definition is ambiguous.

The Department supports allowing laboratories to perform multiple

immunoassay tests for the same drug or drug class. Therefore, the

Department has clarified the definition to ensure that further testing

is consistent with section 2.4(e)(4) which permits conducting multiple

initial tests.

2. Dilution/Adulteration Tests

Several commenters concurred with section 2.1(c) which clarifies

that laboratories may conduct dilution/adulteration testing to

determine the validity of the specimen while some commenters sought to

have the Secretary define the specific tests to be conducted and

require that such tests be performed. The issue regarding the types of

dilution/adulteration testing to be performed has been highly

controversial among forensic laboratory professionals since there is a

lack of data to suggest that dilution/adulteration testing can clearly

identify a donor who has intentionally taken a substance to affect the

outcome of a drug test or has otherwise diluted or adulterated the

specimen. At this time, the Department believes that such testing

should remain optional and the selection of tests to be conducted for

possible dilution/adulteration and the cutoff levels for such tests, if

conducted, should be determined by the laboratories based on their best

judgment.

Two commenters requested that the Department allow dilution/

adulteration testing to be conducted at the collection site. The

Department believes that it is better able to monitor the performance

of such testing when it is conducted by laboratory personnel, rather

than require agencies to monitor such testing at the collection sites.

During the laboratory inspection process, the Department is able to

evaluate the laboratories' performance of such testing to ensure that

tests are performed properly, chain of custody is not broken, and

cross-contamination does not occur from one donor specimen to another

which could impact the integrity of a specimen. The MRO can review the

results of the dilution/adulteration tests and make a decision on the

basis of the test and on his or her interview of the donor to determine

whether a medical factor may have contributed to the results of such

testing. In addition, disallowing the use of dilution/adulteration

testing at the collection site ensures that agency employees are not

unnecessarily subject to observed collection and thus protects the

privacy of individuals to the maximum extent possible.

3. Specimen Collection Procedure

With regard to the specimen collection procedure, a number of

commenters were highly supportive of reducing the required volume of a

urine specimen from 60 mL to 30 mL as stated in section 2.2(f)(10). One

commenter, however, expressed concern that 30 mL is insufficient when

dealing with a specimen that is positive for more than one drug. That

may be the case in some cases. Nevertheless, the number of specimens

that are positive for more than one drug is very small and most volumes

collected generally exceed 30 mL. The Department believes this reduced

volume requirement will make it easier for an individual to provide a

urine specimen with sufficient volume on the first attempt rather than

requiring the collection of a second specimen after drinking a

reasonable quantity of liquid. It is noted that the policy of combining

additional urine, after drinking a reasonable amount of liquid, with a

partial specimen (i.e., an insufficient volume of urine on the first

void) has been eliminated. The Department believes the reduced volume

requirements will ensure that a sufficient volume is collected on the

first void and combining partial specimens will not be necessary.

One commenter expressed concern over the fact that the Mandatory

Guidelines did not specify limitations or guidance as to the amount of

liquid to be given a donor who could not provide a 30 mL urine

specimen. The commenter expressed concerns regarding the possible risk

of water intoxication if there is no limit established for the amount

of liquid that can be provided. The Department concurs and has changed

the example given in section 2.2(f)(10) to read ``(e.g., an 8 oz glass

of water every 30 minutes, but not to exceed a maximum of 24 oz).'' The

example provided describes a reasonable amount of liquid to be provided

and the Department would expect collection sites to use reasonable care

in its determination of the amount of liquid to provide donors.

Several commenters noted that the temperature range stated in the

proposed revisions did not agree with the range stated in the

introductory discussion of the proposed changes. A notice correcting

the error was published in the Federal Register on March 1, 1993. The

correct temperature range is ``32 deg.-38 deg./90 deg.-100 deg.F.''

There was general agreement that the marginally wider temperature

range will not adversely affect the ability to detect a donor who may

possibly tamper with the specimen. Two commenters, however, believe

that the lower limit of the temperature range should be increased. The

Department does not agree with this recommendation. A urine specimen

provided in a collection cup that is at room temperature will cool

quickly; therefore, a narrow temperature range will significantly

increase the number of specimens that will not satisfy the temperature

range requirements. This would cause numerous unnecessary collections

of second specimens and falsely raise suspicions that many donors have

tampered with their specimens.

With regard to the collection of a urine specimen when using direct

observation, one commenter suggested that the employee's agency choose

the observer if there is no collection site person of the same gender

available. The Department agrees and sections 2.2(f)(13), 2.2(f)(16),

and 2.2(f)(23) have been revised to include this requirement. The

Department believes that the agency will select an individual who will

act responsibly and reliably so as not to substantiate any allegation

to the contrary by an employee.

One commenter believes that only trained collectors should be

involved in the collection procedure, especially when direct

observation is required. The Department acknowledges that trained

personnel should be involved in the collection of urine specimens;

however, it is not always possible to ensure that a trained collection

site person of the same gender will be available when a direct

observation is required. Allowing the agency to select an individual to

act as the observer, when there are unusual circumstances, ensures that

the collection will occur promptly and as scheduled rather than

delaying the collection unnecessarily.

One commenter believed that observed collection should never be

used in any circumstances. The Department disagrees. The Department

continues to believe that observed collection is justified and

necessary when there exists reasonable suspicion to believe that the

donor altered or substituted the specimen. Observed collections do not

occur frequently. However, the Department believes that any invasion of

a donor's privacy is greatly outweighed by public health and safety

concerns in such cases.

One commenter recommended that we refer to the individual providing

the urine specimen as the ``donor.'' The Department concurs with the

recommendation and has replaced the word ``individual,'' when it refers

to the person providing a urine specimen, with the word ``donor''

throughout the Guidelines. A definition for donor has been included in

section 1.2. In addition, the use of the word ``donor'' is consistent

with its use on the specimen chain of custody form.

One commenter suggested that the entire collection procedure be

revised substantially to provide more specific guidance to agencies on

the collection process. The Department believes the procedure, as

described, provides sufficient guidance to the agencies on the

collection process, including factors to ensure that urine specimens

are collected properly and satisfy chain of custody requirements. The

changes made in the Mandatory Guidelines with regard to the single

specimen collection procedure and the optional split specimen procedure

should clarify the procedures and, thereby, address many of the

concerns raised by this commenter without completely revising and

expanding the descriptions of the collection procedures.

Many commenters concurred with including an optional split specimen

collection procedure. They believed it was important to include split

specimens since the Omnibus Transportation Employee Testing Act of

1991, Title V of Public Law 102-143, requires using a split specimen

collection procedure for industries regulated by the Department of

Transportation (DOT). This is particularly important since Federal

employees from a number of Departments will be subject to both the

requirements of DOT (49 CFR Part 40) and the requirements of the

Mandatory Guidelines and Executive Order 12564 (September 15, 1986).

Two commenters suggested allowing the use of two or three

containers to collect split specimens. The Department agrees with this

recommendation and has revised the collection procedure to indicate

clearly that either a specimen bottle or a specimen container may be

used when collecting urine specimens. However, when using a split

specimen collection procedure, it is not acceptable for a donor to

provide the split specimens by urinating directly into both Bottle A

and Bottle B. The specimen must be provided by urinating into only one

container or into Bottle A. After the temperature is measured, if the

specimen was provided directly into Bottle A, an appropriate amount is

poured into Bottle B. If a specimen container was used, appropriate

amounts are poured from the specimen container into both Bottle A and

Bottle B. For split specimen collections, this procedure ensures that

the specimens in Bottle A and Bottle B are identical, it is easier to

measure the temperature of a single specimen rather than to measure the

temperature of two specimens that were collected in separate

containers, and it is easier for a donor to provide one specimen in a

single container/bottle rather than into two separate bottles.

It was suggested by several commenters that we specify the amount

of urine to be poured into Bottle B. We concur with that recommendation

and have changed section 2.2(h)(3) of the split specimen procedure to

specify that a minimum of 15 mL of urine shall be poured into Bottle B.

Since Bottle B will only be tested for a specific substance(s), 15 mL

is sufficient to conduct the testing and to allow a sufficient quantity

to be retained frozen if Bottle A is reported positive. Additionally,

section 2.2(h)(1) has been changed to specify that a minimum of 45 mL

of urine is required when using a split specimen collection procedure

rather than the 30 mL minimum when using the single specimen collection

procedure.

One commenter was concerned with the handling and storage of the

split specimen (Bottle B) after the Bottle A specimen is shipped to the

laboratory. We agree that the wording in section 2.2(h)(5) of the split

specimen collection procedure regarding refrigerating the specimens was

confusing and it has been revised. The Department believes that the

most efficient and cost effective way to handle split specimens is to

send both the Bottle A and Bottle B specimens to the laboratory at the

same time including the appropriate specimen chain of custody forms.

This procedure will ensure the integrity of both Bottle A and Bottle B.

This procedure is also simpler and more cost effective than one which

would require the collection site to retain Bottle B specimens until

the results for the Bottle A specimens are reported by the MRO to the

agency and the agency notifies the collection site to either discard

the Bottle B specimens or to ship a specific Bottle B specimen to

another certified laboratory. When both specimens are received by the

laboratory, Bottle A is normally tested within one day and, if

positive, both Bottle A and Bottle B can be placed in secure,

refrigerated storage until the confirmatory test is completed. This

procedure will ensure that both specimens are treated essentially the

same and subject to similar storage conditions until the testing is

completed.

Several commenters were concerned with the impact that a failed to

reconfirm result on the Bottle B specimen would have on a donor since

personnel action may have been taken based on an MRO verified positive

result for Bottle A. Although a failed to reconfirm result for Bottle B

requires the MRO to void the test result for Bottle A and an agency may

be required to reverse any personnel action that may have been taken,

we believe failed to reconfirm reports will occur infrequently and this

possibility should not be the basis for an agency to delay any

personnel action. The Department believes that removing an employee,

for example, from a safety-sensitive position which may impact public

health and safety outweighs the minimal possibility that the testing of

Bottle B will not reconfirm the presence of a drug or metabolite.

In view of the comments, section 2.2(h)(6) has also been clarified

to indicate the MRO's responsibility to report a positive result for

Bottle A. When an MRO has verified the test of the first specimen

bottle (Bottle A) as a positive result, the MRO must report the result

to the agency without waiting for the donor to request that the Bottle

B specimen be tested.

Several commenters expressed concern regarding the actions taken

when a second laboratory fails to reconfirm the presence of a drug or

metabolite in the second specimen bottle (Bottle B) in a split specimen

collection. Since the Bottle B specimen is tested without regard to the

cutoff levels, the result reported by the second laboratory is not

reported as a negative or positive result, but reported as either

reconfirmed or failed to reconfirm the presence of a drug or

metabolite. The Department agrees that if this situation occurs, an

investigation must be conducted. The Department has added this

requirement in section 2.2(h)(8) of the Mandatory Guidelines and has

required the MRO to notify the donor's agency. In addition, the Federal

agency must contact the Secretary and the Secretary will investigate

the failed to reconfirm result and attempt to determine the reason for

the inconsistent results between Bottle A and Bottle B. HHS will report

its findings to the Federal agency and ensure that appropriate action

is taken to prevent the recurrence of the failed to reconfirm result.

Some commenters simply did not like permitting Federal agencies to

have the option of a split specimen procedure, believing, for example,

that the use of a split specimen procedure gives the perception of a

lack of confidence in the results when using a single specimen

collection, that the additional administrative and collection costs are

not justified, and that there is an increased risk of administrative

errors.

It should be noted that certain Federal employees are subject to

both the Mandatory Guidelines and the Omnibus Transportation Employee

Act of 1991, Title V of Public Law 102-431, (Omnibus Act) which

requires split specimens. Therefore, the agencies must have the

flexibility to collect split specimens as required by the Omnibus Act.

Since Federal agencies may also request a waiver under section 1.1(e)

of the Mandatory Guidelines and the Department has provided a number of

agencies with a waiver to permit split specimens during the past 5

years, the Department believes including an optional split specimen

collection procedure in the Mandatory Guidelines will ensure

consistency among all agencies currently using split specimens and

those wanting to implement split specimen collections. In addition,

each agency should have the option of treating its employees equally

rather than treating its employees under the Omnibus Act differently

from the employees only subject to the Mandatory Guidelines.

With regard to the perception that the results from a single

specimen collection are unreliable and not adequate to protect employee

rights when compared to a split specimen collection, the Department is

confident that the results from a single specimen collection are

scientifically and legally supportable. This belief is based on the

stringent requirements that have been established by the Mandatory

Guidelines--that is, requiring the use of rigorous chain of custody

procedures when handling and testing specimens; requiring laboratories

to use qualified and trained personnel, validated analytical testing

procedures, and extensive internal quality control and quality

assurance procedures; requiring laboratories to participate in a

comprehensive certification program that includes performance testing

samples and semi-annual inspections; and using MROs to ensure that

procedures have been followed as required.

Although the split specimen procedures are designed to minimize

administrative errors, the Department acknowledges that any time

procedures are modified the risk of administrative errors increases.

However, the use of a standard specimen chain of custody form should

minimize such errors and the Department, through the inspection

process, will monitor the laboratories' procedures in processing split

specimens.

The procedures for split specimens are also designed to keep the

administrative burden at a minimum. The Department believes that the

paperwork for collection sites or laboratories will not increase much

since the collection sites will be using a seven-part chain of custody

form instead of a six-part form and sending both split specimens to the

laboratory at the same time and in the same shipping container. This

should minimize the additional cost and administrative burden on both

collection sites and laboratories.

One commenter believed that split specimen collections create a

potential to reverse results especially if there is a significant

variation in the analytical sensitivities of the confirmatory tests

used by each of the HHS-certified laboratories. The Department is aware

of this potential and has provided guidance to the laboratories with

regard to their capability to accurately quantitate and identify drugs

at concentrations that are 40 percent of the confirmatory test levels.

The Department believes this guidance and challenging laboratories with

performance testing samples at these low concentrations will ensure

that all laboratories have essentially the same sensitivity for each of

the confirmatory tests.

Finally, one commenter requested guidance on whether the donor or

agency would be responsible for paying the costs associated with

analyzing the split specimen. The Department believes that the decision

regarding financial responsibility for testing Bottle B is one the

agencies must decide.

4. Certifying Test Results

One commenter stated that the proposed revision to section 2.3(b)

that discusses ``test validation'' did not make it clear that a

laboratory may use a certifying scientist who is only certified to

review initial drug tests which are negative. Although this is the

intent of this section and to ensure that no confusion exists, the

title of section 2.3(b) has been changed to read ``Certifying Test

Results'' and that section has been revised to state clearly that a

laboratory may designate a certifying scientist(s) that is only

qualified to certify results that are negative on the initial test. We

note, however, that if a certifying scientist certifies confirmatory

test results, the individual must have training and experience in all

``procedures relevant to the results that the individual certifies.''

This includes both initial test and confirmatory test procedures.

Changing the title of this section to read ``Certifying Test Results''

should also ensure that we are referring to the review and

certification of specimen test results rather than the results

associated with ``validating'' an analytical procedure before it is

used to test specimens. The Department believes there was some

confusion associated with the former title of this section.

5. Security and Chain of Custody

One commenter requested that the security requirements in section

2.4(a)(1), as proposed, be revised to allow emergency personnel access

to all sections of the laboratory without escorts. The requirements for

security pertain to limiting and documenting access under normal

situations and providing escorts for authorized visitors, maintenance,

and service personnel. For real emergencies, such as fires, it would be

inappropriate to require the laboratory to provide an escort. This

section has been changed to ensure that emergency personnel (such as

firefighters) can have unescorted access similar to that authorized for

inspectors. As suggested by the commenter, it would be acceptable for

the laboratory to document the emergency and include, to the extent

practicable, dates, time of entry and exit, and purpose of entry for

all emergency response personnel. It must be noted that this exception

does not apply to emergency ``service'' personnel, such as

manufacturers' technical representatives who are called to repair an

instrument or to conduct routine service.

6. Specimen Processing

One commenter noted that the word ``standards'' had been used

incorrectly in section 2.4(d), as proposed, when stating the

requirements for each initial and confirmatory batch. The Department

concurs and has changed this section to state that each initial and

confirmatory batch must satisfy the quality control requirements in

sections 2.5(b) and 2.5(c), respectively, rather than using terms such

as ``standards'' and ``controls.'' Additionally, the last sentence of

this section has been deleted because it is not entirely correct.

Quality control samples must be known to laboratory technicians

conducting the testing while only blind performance testing samples are

unknown (i.e., the location in the batch, drug or metabolite present,

and concentration). The requirements for laboratory blind performance

testing samples and agency blind samples are discussed in section 2.5.

7. Marijuana Initial Test Level

Many respondents concurred with lowering the initial test level for

marijuana metabolites from 100 to 50 ng/mL as proposed in section

2.4(e). However, one commenter claimed that the lowered cutoff

concentration would identify the occasional user. The intent of Federal

workplace drug testing programs is to identify individuals who use

illegal substances regardless of whether they are regular or occasional

users. Lowering the initial test level should increase the ability to

detect any use of marijuana.

Another commenter questioned the impact that might result by the

lowered cutoff concentration for those individuals who are exposed to

passive inhalation (i.e., breathing the smoke exhaled by another

individual smoking marijuana cigarettes). The Department does not

believe that passive inhalation is a reasonable defense or that

significant exposure can occur through passive inhalation to cause a

urine specimen to be reported positive. A comprehensive study of

passive inhalation conducted at the National Institute on Drug Abuse's

Addiction Research Center in Baltimore (see Cone, E.J., et al., Passive

Inhalation of Marijuana Smoke: Urinalysis and Room Air Levels of Delta-

9-Tetrahydrocannabinol, Journal of Analytical Toxicology, 11: 89-96,

1987) indicates that it takes extensive exposure to extremely high

concentrations under unrealistic conditions to cause a positive result;

therefore, passive inhalation is not a reasonable explanation for a

positive result.

8. Initial and Confirmatory Tests

One commenter believed that the wording in section 2.4(e)(3), as

proposed, conflicted with the authority to conduct dilution/

adulteration tests as stated in section 2.1(c). The Department agrees

that this section needs to be clarified. A laboratory may conduct

dilution/adulteration tests on all specimens, whether they are positive

or negative, and either before or after conducting the initial test.

Section 2.4(e)(3) has been changed to clarify this policy.

Several commenters questioned the use of specimens that test

negative on either the initial test or the confirmatory test for the

laboratory's internal quality control program as proposed in sections

2.4(e)(3) and 2.4(f)(3). These commenters were concerned that the

results may have been affected by such factors as medications that may

have been taken, the health of the donors, and possible unknown

problems with confirmation, thereby, making these specimens unsuitable

as quality control samples. Several of these commenters recommended the

use of certified negative urine or, at a minimum, confirming the

negative pool by GC/MS prior to its use in a quality control program.

In response to these concerns, the Department notes that the

laboratory's operation must be consistent with good forensic laboratory

practice (see section 3.20(c)) and such practice requires a laboratory

to always certify a urine pool as negative before it is used to prepare

negative samples or to prepare other quality control samples. If pooled

urine does not satisfy the criteria for acceptability, it is discarded.

Such certification of the urine will ensure the quality of a

laboratory's internal quality control program.

9. Multiple Initial Tests

Two commenters supported the use of multiple initial tests as

stated in section 2.4(e)(4), as proposed, while several commenters

expressed concern with permitting the use of multiple testing. The

Department believes that the use of multiple initial tests may reduce

the number of presumptive positives that are forwarded to confirmatory

testing that will not be confirmed and may allow obtaining a valid

analytical result if a specimen is untestable on one immunoassay test.

The use of multiple initial tests has been widely used with regard to

testing for amphetamines and this policy should apply to all drugs.

In addition, there are reports that various substances, including

prescription medications, can prevent obtaining a valid initial test

result when using one immunoassay test. We believe it is appropriate to

use a different immunoassay test in order to obtain a valid initial

test result before reporting the specimen as ``test not performed'' and

including an appropriate comment on the specimen chain of custody form.

To clarify this issue, the example given in section 2.4(e)(4) has been

changed to include the use of a second immunoassay test for untestable

specimens.

It is noted that the last sentence of section 2.4(e)(4), as

proposed, has been deleted since it is redundant with the requirements

as stated in the first sentence of the section.

10. 200 ng/mL Amphetamine Reporting Rule

Six commenters concurred with the proposal in sections 2.4(f)(1)

and 2.4(g)(2) that require a methamphetamine positive to contain at

least 200 ng/mL of amphetamine before reporting the result as positive.

Two commenters recommended that the 200 ng/mL rule be dropped entirely

because they believed it is no longer relevant and the emphasis should

be on improving the quality of the GC/MS confirmatory procedure. Seven

commenters held similar views that the 200 ng/mL rule is too

conservative and produces too many false negatives and recommended that

it be lowered to either 100 or 50 ng/mL or at least equal to or greater

than the limit of detection for amphetamine.

The Department believes that the 200 ng/mL requirement implemented

as a temporary policy since December 22, 1990, is a necessary one to

prevent false positive test results. On a special set of performance

testing samples provided to the laboratories by the program, the

Department found that the requirement adequately controlled all of the

possible technical problems based on observations of results reported

by the laboratories on that set of performance testing samples. The

results indicated that a significant number of laboratories experienced

chromatographic resolution problems when methamphetamine was present

with ephedrine and 2% of the performance testing results evidenced a

methamphetamine response when challenged with high concentrations of

over-the-counter medications (e.g., ephedrine, pseudoephedrine, or

phenylpropanolamine). These results indicated that the 200 ng/mL rule

was effective in preventing any false positive results and should be

continued. In addition, recent information provided by laboratories

regarding their limits of quantitation and their results on performance

testing samples that contained very low concentrations of amphetamine

and methamphetamine indicate that 200 ng/mL continues to be the lowest

concentration that most of the laboratories can reliably identify and

quantitate for either methamphetamine or amphetamine. For these

reasons, the Department believes using a lower concentration or

eliminating the 200 ng/mL rule would increase the possibility for

reporting a false positive methamphetamine result.

11. Reporting Results

One commenter was concerned that substituting ``certifying

scientist'' in section 2.4(g)(5), as proposed, for the responsible

person was making the certifying scientist responsible for the overall

laboratory operations. We believe the commenter did not understand the

purpose for changing the wording in this section. The use of

``certifying scientist'' in this section ensures that the requirement

is consistent with current program practice. The responsible person

continues to be responsible for the overall operation of the laboratory

(see section 2.3(a)); however, section 2.4(g)(5) allows a certifying

scientist to sign the external chain of custody form that is sent to

the MRO.

12. Calibrators and Controls

One commenter raised concern with the materials used to prepare

calibrators and controls which as described in section 2.4(n)(2) only

allowed calibrators and controls to be prepared from pure drug

standards. The commenter correctly indicated that calibrators and

controls were available from other sources. The Department concurs and

has revised the sentence to allow calibrators and controls to be

prepared not only from pure drug reference materials, but from stock

standard solutions obtained from other laboratories, or from commercial

manufacturers. This change clarifies that laboratories have the

flexibility to obtain ``standards'' used to prepare the calibrators and

controls from different sources.

13. Potential Conflicts of Interest

Several commenters supported the policies in sections 2.4(n)(6) and

2.6(b), as proposed, that restricts the types of relationships between

laboratories and Medical Review Officers to ensure there were no

conflicts of interest. There were several comments submitted, however,

stating that these requirements were not necessary since there is no

evidence that MROs have not acted in the interest of the donor or that

current arrangements have adversely affected the ability of an MRO to

monitor laboratories. The Department does not question the dedication

and integrity of its certified laboratories and the MROs in carrying

out their responsibilities and protecting the interests of the Federal

agencies and donors. Nevertheless, the Department believes the issue

must be addressed.

The MRO plays an essential role in the Federal drug testing

program. See generally section 2.6 of the Mandatory Guidelines. The MRO

is a licensed physician with a knowledge of substance abuse disorders

who verifies whether the tests are positive or negative. In the case of

a positive result reported by the laboratory, the Mandatory Guidelines

require that the MRO contact the employee and personally interview the

employee, i.e., in-person or by telephone, to determine whether

alternate medical explanations would explain a positive result. See

section 2.6(c). During the course of such interview and possibly

through having the specimen retested, the MRO may identify false

positive test results. In such a case, the MRO is required to contact

the Secretary so that the Department can conduct an investigation into

the matter and take whatever action is necessary to prevent such a

result from occurring in the future. See section 2.6(g).

Because the MRO plays such an essential role, the Department

believes any relationship that may be construed as a potential conflict

of interest may be sufficient to undermine the integrity of the

program. Every Federal agency, employee, and job applicant must have

complete assurance that test results will be thoroughly reviewed and,

if errors are discovered, that the MRO will report the error and an

appropriate investigation and corrective action will be taken.

14. Laboratory Quality Control Requirements for Initial Tests

There were several comments submitted regarding the requirements in

section 2.5(b), as proposed, for quality control samples when

conducting the initial test. The commenters believed the proposed

requirements were confusing and suggested using different terms to

describe the types of quality controls that must be included in each

initial test batch. The Department concurs that the quality control

requirements in this section were confusing and they have been revised

based on the definitions in section 1.2. It should be noted the changes

to this section only clarify the requirements for quality control

samples; the actual policy has not changed from the original Mandatory

Guidelines. See section 2.5(b) of 53 FR 11979, 11984 (April 11, 1988).

We have also revised the quality control requirements for each

confirmatory test batch in section 2.5(c) using the new definitions in

section 1.2 without changing the policy as compared to the original

Mandatory Guidelines. See section 2.5(c) of 53 FR 11979, 11985 (April

11, 1988).

In addition, it was noted that there was an error in the

requirement that each initial test batch must contain a minimum of 20%

quality control samples. A correction stating that 10% was the minimum

amount was published in the Federal Register on March 1, 1993.

15. Agency Blind Sample Program

A number of commenters supported reducing the requirements for

agency blind samples from 10% to 3% as indicated in section 2.5(d)(2).

One commenter suggested retaining the 10% minimum and one commenter

suggested establishing a minimum number of blind samples per quarter

for organizations with a small test population. The Department believes

the reduced requirement will not have a significant impact on the

ability of an agency to evaluate its entire drug testing program;

however, there is no prohibition for an agency to use a higher

percentage or a higher number of blind samples to be submitted with

donor specimens.

The Department has also changed the requirements for the number of

blind samples to be submitted with donor specimens during the initial

90-day period of any new contract to conform with reducing the

requirements of blind samples as provided by section 2.5(d)(2). Our

experience during the past 5 years suggests that it is not necessary to

submit large numbers of blind samples to verify the testing conducted

by the certified laboratories.

16. Reanalysis Authorized

Two commenters expressed concern with the retesting policy proposed

in section 2.6(e) which provided that only the MRO was authorized to

order a reanalysis of the original specimen or Bottle B from a split

specimen collection. One commenter believes the donor was authorized to

request a retest of the original specimen. It is the Department's

position that if an MRO cannot verify a positive result for whatever

reason, only the MRO is authorized to request the retest of the

original specimen since the MRO is the only individual who has all the

information necessary to identify a particular specimen in a

laboratory.

Another commenter pointed out an inconsistency between the retest

policy proposed in this section and the policy proposed for testing

Bottle B from a split specimen collection as described in section

2.2(h)(6) which states that only the donor may request through the MRO

that the second specimen bottle (Bottle B) be tested. The Department

agrees that there is an inconsistency in the proposed policies because

we inadvertently referred to the Bottle B specimen in section 2.6(e)

rather than the Bottle A specimen. Section 2.6(e) has been changed to

clarify that only the MRO may request the retest of either a single

specimen or a Bottle A specimen when using a split specimen collection.

The procedures for the testing of Bottle B remain as proposed in

section 2.2(h)(6)--that is, only the donor may request through the MRO

that Bottle B be tested.

17. Reporting Final Results to the Agency

One commenter suggested that section 2.6(h), as proposed, which

clarifies the requirement that the MRO provide written reports to the

agency on positive and negative drug test results would significantly

increase the administrative costs associated with the program and

recommended that the MRO be required to provide written reports to the

agency for positive results only. The Department disagrees. Written

reports from the MRO to the agency on all specimens tested ensures that

all specimens have been tested and the results of all specimens have

been reviewed by the MRO. In addition, the Department believes that

this requirement for written reports to the agency does not prevent the

MRO from reporting several results on the same correspondence sent to

the agency and, therefore, should not significantly affect the cost

associated with the MRO review of drug testing results.

18. Certified Laboratories Notifying Private Sector Clients

Two commenters were concerned that the policy in section 3.4 did

not adequately ensure that a laboratory would inform clients if and

when the laboratory did not satisfy the certification requirements. The

Department concurs that a laboratory must inform its clients when its

certification has been suspended. Since the program began, this

notification has been required and is set out in the suspension letter

that is sent to the laboratory.

However, the intent of the requirement in section 3.4 that

certified laboratories clearly inform clients when procedures followed

do not conform to the Mandatory Guidelines is not related to suspension

and/or proposed revocation actions. The purpose is to ensure that

unregulated, private sector clients are aware that the laboratory may

be using procedures that are not subject to or in accordance with the

Mandatory Guidelines. The Department believes that a certified

laboratory must not use its certification to promote itself as such if,

in fact, it uses procedures that do not comply with the Mandatory

Guidelines for such clients. This section has been revised to clarify

this requirement.

19. Performance Testing Program

There were several comments submitted regarding changing the

performance testing (PT) program from a bimonthly program to a

quarterly program as stated in various sections of subpart C. One

commenter disagreed with changing the performance testing program to a

quarterly program because this would prolong the recertification

process and suggested that a monthly PT program would be more

appropriate. The Department has no intention of changing the initial

certification procedures or to change the procedures when a laboratory

has been suspended and must successfully analyze performance testing

samples prior to having the suspension lifted. In addition, the

Department believes a monthly PT program does not allow sufficient time

for a laboratory to receive its results on a set of PT samples, analyze

its performance, and initiate appropriate corrective action before the

next cycle of PT samples.

One commenter was concerned that adopting a quarterly PT program

without changing the criteria for determining acceptable performance,

as set out in section 3.19, would increase the period for evaluating a

laboratory's performance to 9 months. The Department concurs that the

criteria for determining acceptable performance, that is, performance

on 3 consecutive quarterly PT cycles, would unduly lengthen the time

before corrective action may be taken. Since the total number of PT

samples in 2 cycles of the quarterly PT program will be essentially the

same as those for 3 cycles of the bimonthly PT program, it is

appropriate to establish acceptable performance criteria based on

performance over 2 consecutive cycles of quarterly PT samples. All

criteria in section 3.19 that pertain to evaluating the performance of

certified laboratories have been changed to evaluate acceptable

performance over 2 consecutive cycles rather than over 3 consecutive

cycles, which retains the 6-month evaluation period.

One commenter agreed with the change in section 3.19(b)(4), as

proposed, that would allow a certified laboratory to have one

quantitative result greater than 50% from the target value without

requiring program action against the laboratory. However, the commenter

is concerned that the cause for the error may not be investigated since

program action is not taken against the laboratory. The Department did

not intend that this change would prevent any investigation into the

cause for the error or that the laboratory would not be required by the

Department to make a concerted effort to determine the cause for the

error and to take appropriate corrective action.

One commenter believes that the overall costs for the certification

program may be decreased without compromising the high quality of the

program by increasing the PT challenges to a monthly program and

decreasing the maintenance inspections to once a year. The Department

disagrees with this proposal because it is important to inspect

laboratories at least every six months to ensure that the laboratory

has continued to satisfy the requirements of the Mandatory Guidelines

and for the inspectors to review the results reported for the PT

samples. If corrective action is necessary, it will be more timely than

if inspections were on a yearly basis. In addition, the existence of a

significant problem over a long period of time would possibly

jeopardize the results of many more personnel specimens.

20. Corrective Action by Certified Laboratories

Several commenters expressed concern that section 3.12(c), as

proposed, would give the Secretary the authority to review all results

and activities associated with a laboratory's testing of specimens for

private sector, unregulated clients. This was not the intent and the

section has been changed to indicate that the Secretary has authority

to review results for specimens collected for private sector clients

that were tested by the certified laboratory under the Mandatory

Guidelines to the extent necessary to ensure the full reliability of

drug testing for Federal agencies.

21. Recertification

One commenter was concerned with the policy contained in section

3.16, as proposed, because the commenter believed the procedure to

regain certification after the laboratory's certification has been

revoked would be prolonged given that the maintenance PT program has

been reduced to a quarterly program. The commenter misunderstood that

provision. The Department has not changed the initial certification

procedure (section 3.16) under which a laboratory that had its

certification revoked must proceed to regain certification. Thus, such

a laboratory will proceed as in the past and must satisfactorily

perform in each phase of the initial certification process. However,

the first sentence of section 3.16 has been changed to indicate that

the recertification policy applies only when a laboratory has its

certification revoked.

22. Inspection Performance

One commenter was concerned that the meaning of the phrase

``consistent with good forensic laboratory practice'' in section

3.20(c), as proposed, was too subjective. The commenter believes that

each inspection team interprets laboratory's procedures differently,

thereby, what is acceptable during one inspection may be unacceptable

during the next inspection. We do not concur with this assessment of

the inspection process. Although there is some inherent subjectivity in

the inspection process when applying certain criteria under the

Mandatory Guidelines, the inspectors are provided clear guidance on

what is to be inspected and what is acceptable and unacceptable. The

Department requires trained, qualified inspectors to use a

comprehensive checklist consisting of some 300 questions to evaluate a

laboratory's procedures. They are asked to respond ``yes'' or ``no'' to

the questions and then provide comments if the answer is unacceptable.

This checklist ensures that each inspector is reviewing essentially all

of the same laboratory documents and results. The inspection reports

are reviewed by the Department to ensure that program requirements and

policies are applied consistently among all laboratories. In addition,

it is the responsibility of each laboratory to review the Mandatory

Guidelines, to be aware of what is to be inspected by reviewing the

checklist and other program documents, to correct deficiencies, and to

use good forensic laboratory practice in its testing program.

One commenter suggested that the word ``all'' be deleted from the

second sentence in section 3.20(c), as proposed, because a laboratory

is not required to correct ``all'' deficiencies identified by the

inspectors. We concur with the comment and have deleted the word

``all.'' The Department's policy has always been to include minor

deficiencies or concerns in the critique developed from the inspection

reports and give the laboratory the option to take whatever additional

corrective action it deems appropriate for these minor deficiencies or

concerns.

23. Procedures for Review of Suspension or Proposed Revocation of a

Certified Laboratory

One commenter suggests that the definition of appellant in section

4.2, as proposed, is unclear and believes that the review procedures

only apply when there is a proposed revocation. The Department

disagrees with this position. The Department believes that principles

of fairness necessitate allowing laboratories to seek internal reviews

not only of proposed revocations but also internal reviews of immediate

suspensions.

24. Other Minor Changes

In addition to the changes discussed above, there were several

minor changes made in other sections. The acronym ``MRO'' has been

added to the definition for Medical Review Officer in section 1.2.

Since the original Guidelines were published, the ``MRO'' acronym has

become a common and accepted way to refer to a physician performing

this function. We have replaced ``Medical Review Officer'' with ``MRO''

throughout the Guidelines.

Section 2.5(d)(4) was changed to clarify that an agency shall

investigate any unsatisfactory blind performance testing results and

submit its findings to HHS rather than HHS conducting the initial

investigation. The Department believes the agency must gather all

pertinent information and investigate the reason before HHS is

contacted to continue the investigation and to ensure that the

laboratory has taken corrective action.

Section 2.6(c) has been simplified to require the MRO to send

results only to the designated person in the agency rather than to both

agency's Employee Assistance Program and to the agency's management

official. The Department believes that the agency should have the

discretion to determine who should receive results.

Section 3.3 was clarified to read that a laboratory must satisfy

all pertinent provisions of the Guidelines in order to maintain

certification while the original requirement only addressed satisfying

the provisions in order to qualify for certification.

Section 3.15(b) was revised to conform with the review procedure in

new subpart D which allows laboratories the opportunity for an informal

review of a program action within 30 days of the date the laboratory

received the notice, or if seeking an expedited review, within 3 days

of the date the laboratory received the notice.

Two commenters noted that section 3.18(b) referred to a subset of

PT samples as ``directed specimens'' rather than as ``retest samples''

which is current program terminology. We concur with the comment

submitted and have revised the section to refer to these PT samples as

``retest samples.''

Other appropriate minor editorial changes have been made for

clarity and consistency.

Information Collection Requirements

Any comments related to the Paperwork Reduction Act of 1980 may be

sent to the HHS Desk Officer, Office of Information and Regulatory

Affairs, Office of Management and Budget, room 3001, New Executive

Office Building, Washington, DC 20503.

Information collection and recordkeeping requirements which would

be imposed on laboratories engaged in urine drug testing for Federal

agencies concern quality assurance and quality control; security and

chain of custody; documentation; reports; performance testing; and

inspections as set out in sections 3.7, 3.8, 3.10, 3.11, 3.17, and

3.20. To facilitate ease of use and uniform reporting, a specimen chain

of custody form has been developed as referenced in sections 1.2,

2.2(c), and 2.2(f).

The information collection and recordkeeping requirements contained

in these Mandatory Guidelines have been submitted to the Office of

Management and Budget for review under section 3504(h) of the Paperwork

Reduction Act of 1980.

Dated: February 7, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Dated: March 16, 1994.

Donna E. Shalala,

Secretary.

The Mandatory Guidelines as revised are hereby adopted in

accordance with Executive Order 12564 and section 503 of Pub. L. 100-

71. For the public's convenience the Mandatory Guidelines as revised

are set out in full as follows:

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Subpart A--General

1.1 Applicability.

1.2 Definitions.

1.3 Future Revisions.

Subpart B--Scientific and Technical Requirements

2.1 The Drugs.

2.2 Specimen Collection Procedures.

2.3 Laboratory Personnel.

2.4 Laboratory Analysis Procedures.

2.5 Quality Assurance and Quality Control.

2.6 Reporting and Review of Results.

2.7 Protection of Employee Records.

2.8 Individual Access to Test and Laboratory Certification Results.

Subpart C--Certification of Laboratories Engaged in Urine Drug Testing

for Federal Agencies

3.1 Introduction.

3.2 Goals and Objectives of Certification.

3.3 General Certification Requirements.

3.4 Capability to Test for Five Classes of Drugs.

3.5 Initial and Confirmatory Capability at Same Site.

3.6 Personnel.

3.7 Quality Assurance and Quality Control.

3.8 Security and Chain of Custody.

3.9 One-Year Storage for Confirmed Positives.

3.10 Documentation.

3.11 Reports.

3.12 Certification.

3.13 Revocation.

3.14 Suspension.

3.15 Notice.

3.16 Recertification.

3.17 Performance Testing (PT) Requirement for Certification.

3.18 Performance Test Samples Composition.

3.19 Evaluation of Performance Testing.

3.20 Inspections.

3.21 Results of Inadequate Performance.

3.22 Listing of Certified Laboratories.

Subpart D--Procedures for Review of Suspension or Proposed Revocation

of a Certified Laboratory

4.1 Applicability.

4.2 Definitions.

4.3 Limitations on Issues Subject to Review.

4.4 Specifying Who Represents the Parties.

4.5 The Request for Informal Review and the Reviewing Official's

Response.

4.6 Abeyance Agreement.

4.7 Preparation of the Review File and Written Argument.

4.8 Opportunity for Oral Presentation.

4.9 Expedited Procedures for Review of Immediate Suspension.

4.10 Ex Parte Communications.

4.11 Transmission of Written Communications by Reviewing Official

and Calculation of Deadlines.

4.12 Authority and Responsibilities of Reviewing Official.

4.13 Administrative Record.

4.14 Written Decision.

4.15 Court Review of Final Administrative Action; Exhaustion of

Administrative Remedies.

Authority: E.O. 12564 and Sec. 503 of Pub. L. 100-71.

Subpart A--General

Section 1.1 Applicability.

(a) These mandatory 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) And 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.

(b) Subpart C of these Guidelines (which establishes laboratory

certification standards) applies to any laboratory which has or seeks

certification to perform urine drug testing for Federal agencies under

a drug testing program conducted under E.O. 12564. Only laboratories

certified under these standards are authorized to perform urine drug

testing for Federal agencies.

(c) The Intelligence Community, as defined by Executive Order No.

12333, shall be subject to these Guidelines only to the extent agreed

to by the head of the affected agency.

(d) These Guidelines do not apply to drug testing conducted under

legal authority other than E.O. 12564, including testing of persons in

the criminal justice system, such as arrestees, detainees,

probationers, incarcerated persons, or parolees.

(e) Agencies may not deviate from the provisions of these

Guidelines without the written approval of the Secretary. In requesting

approval for a deviation, an agency must petition the Secretary in

writing and describe the specific provision or provisions for which a

deviation is sought and the rationale therefor. The Secretary may

approve the request upon a finding of good cause as determined by the

Secretary.

(f) Agencies shall purchase drug testing services only from

laboratories certified by HHS or an HHS-recognized certification

program in accordance with these Guidelines.

Section 1.2 Definitions

For purposes of these Guidelines the following definitions are

adopted:

Aliquot. A fractional part of a specimen used for testing. It is

taken as a sample representing the whole specimen.

Calibrator. A solution of known concentration used to calibrate a

measurement procedure or to compare the response obtained with the

response of a test specimen/sample. The concentration of the analyte of

interest in the calibrator is known within limits ascertained during

its preparation. Calibrators may be used to establish a calibration

curve over a range of interest.

Certifying Scientist. An individual with at least a bachelor's

degree in the chemical or biological sciences or medical technology or

equivalent who reviews all pertinent data and quality control results.

The individual shall have training and experience in the theory and

practice of all methods and procedures used in the laboratory,

including a thorough understanding of chain of custody procedures,

quality control practices, and analytical procedures relevant to the

results that the individual certifies. Relevant training and experience

shall also include the review, interpretation, and reporting of test

results; maintenance of chain of custody; and proper remedial action to

be taken in response to test systems being out of control-limits or

detecting aberrant test or quality control results.

Chain of Custody. Procedures to account for the integrity of each

urine specimen by tracking its handling and storage from point of

specimen collection to final disposition of the specimen. These

procedures shall require that an Office of Management and Budget (OMB)

approved specimen chain of custody form be used from time of collection

to receipt by the laboratory and that upon receipt by the laboratory an

appropriate laboratory chain of custody form(s) account for the

specimens and samples within the laboratory. Chain of custody forms

shall, at a minimum, include an entry documenting date and purpose each

time a specimen or sample is handled or transferred and identifying

every individual in the chain of custody.

Collection Site. A place designated by the agency where individuals

present themselves for the purpose of providing a specimen of their

urine to be analyzed for the presence of drugs.

Collection Site Person. A person who instructs and assists

individuals at a collection site and who receives and makes an initial

examination of the urine specimen provided by those individuals. A

collection site person shall have successfully completed training to

carry out this function.

Confirmatory Test. A second analytical procedure to identify the

presence of a specific drug or metabolite which is independent of the

initial test and which uses a different technique and chemical

principle from that of the initial test in order to ensure reliability

and accuracy. (At this time gas chromatography/mass spectrometry (GC/

MS) is the only authorized confirmation method for cocaine, marijuana,

opiates, amphetamines, and phencyclidine.)

Control. A sample used to monitor the status of an analysis to

maintain its performance within desired limits.

Donor. The individual from whom a urine specimen is collected.

Initial Test (also known as Screening Test). An immunoassay test to

eliminate ``negative'' urine specimens from further consideration and

to identify the presumptively positive specimens that require

confirmation or further testing.

Laboratory Chain of Custody Form. The form(s) used by the testing

laboratory to document the security of the specimen and all aliquots of

the specimens during testing and storage by the laboratory. The form,

which may account for an entire laboratory test batch, shall include

the names and signatures of all individuals who accessed the specimens

or aliquots and the date and purpose of the access.

Medical Review Officer (MRO). A licensed physician responsible for

receiving laboratory results generated by an agency's drug testing

program who has knowledge of substance abuse disorders and has

appropriate medical training to interpret and evaluate an individual's

positive test result together with his or her medical history and any

other relevant biomedical information.

Quality Control Sample. A sample used to evaluate whether or not

the analytical procedure is operating within predefined tolerance

limits. Calibrators, controls, negative urine samples, and blind

samples are collectively referred to as ``quality control samples'' and

each as a ``sample.''

Reason to Believe. Reason to believe that a particular individual

may alter or substitute the urine specimen as provided in section 4(c)

of E.O. 12564.

Sample. A representative portion of a urine specimen or quality

control sample used for testing.

Secretary. The Secretary of Health and Human Services or the

Secretary's designee. The Secretary's designee may be a contractor or

other recognized organization which acts on behalf of the Secretary in

implementing these Guidelines.

Specimen. The portion of urine that is collected from a donor.

Specimen Chain of Custody Form. An OMB approved form used to

document the security of the specimen from time of collection until

receipt by the laboratory. This form, at a minimum, shall include

specimen identifying information, date and location of collection, name

and signature of collector, name of testing laboratory, and the names

and signatures of all individuals who had custody of the specimen from

time of collection until the specimen was prepared for shipment to the

laboratory.

Standard. A reference material of known purity or a solution

containing a reference material at a known concentration.

Section 1.3 Future Revisions

In order to ensure the full reliability and accuracy of drug

assays, the accurate reporting of test results, and the integrity and

efficacy of Federal drug testing programs, the Secretary may make

changes to these Guidelines to reflect improvements in the available

science and technology. These changes will be published in final as a

notice in the Federal Register.

Subpart B--Scientific and Technical Requirements

Section 2.1 The Drugs

(a) The President's Executive Order 12564 defines ``illegal drugs''

as those included in Schedule I or II of the Controlled Substances Act

(CSA), but not when used pursuant to a valid prescription or when used

as otherwise authorized by law. Hundreds of drugs are covered under

Schedule I and II and while it is not feasible to test routinely for

all of them, Federal drug testing programs shall test for drugs as

follows:

(1) Federal agency applicant and random drug testing programs shall

at a minimum test for marijuana and cocaine;

(2) Federal agency applicant and random drug testing programs are

also authorized to test for opiates, amphetamines, and phencyclidine;

and

(3) When conducting reasonable suspicion, accident, or unsafe

practice testing, a Federal agency may test for any drug listed in

Schedule I or II of the CSA.

(b) Any agency covered by these guidelines shall petition the

Secretary in writing for approval to include in its testing protocols

any drugs (or classes of drugs) not listed for Federal agency testing

in paragraph (a) of this section. Such approval shall be limited to the

use of the appropriate science and technology and shall not otherwise

limit agency discretion to test for any drugs covered under Schedule I

or II of the CSA.

(c) Urine specimens collected pursuant to Executive Order 12564,

Public Law 100-71, and these Guidelines shall be used only to test for

those drugs included in agency drug-free workplace plans and may not be

used to conduct any other analysis or test unless otherwise authorized

by law except if additional testing is required to determine the

validity of the specimen. Urine that tests negative by initial or

confirmatory testing may, however, be pooled for use in the

laboratory's internal quality control program.

(d) These Guidelines are not intended to limit any agency which is

specifically authorized by law to include additional categories of

drugs in the drug testing of its own employees or employees in its

regulated industries.

Section 2.2 Specimen Collection Procedures

(a) Designation of Collection Site. Each agency drug testing

program shall have one or more designated collection sites which have

all necessary personnel, materials, equipment, facilities, and

supervision to provide for the collection, security, temporary storage,

and shipping or transportation of urine specimens to a certified drug

testing laboratory.

(b) Security. Procedures shall provide for the designated

collection site to be secure. If a collection site facility is

dedicated solely to urine collection, it shall be secure at all times.

If a facility cannot be dedicated solely to drug testing, the portion

of the facility used for testing shall be secured during drug testing.

(c) Chain of Custody. Chain of custody standardized forms shall be

properly executed by authorized collection site personnel upon receipt

of specimens. Handling and transportation of urine specimens from one

authorized individual or place to another shall always be accomplished

through chain of custody procedures. Every effort shall be made to

minimize the number of persons handling specimens.

(d) Access to Authorized Personnel Only. No unauthorized personnel

shall be permitted in any part of the designated collection site when

urine specimens are collected or stored.

(e) Privacy. Procedures for collecting urine specimens shall allow

individual privacy unless there is reason to believe that a particular

donor may alter or substitute the specimen to be provided.

(f) Integrity and Identity of Specimen. Agencies shall take

precautions to ensure that a urine specimen not be adulterated or

diluted during the collection procedure and that information on the

urine bottle and on the specimen chain of custody form can identify the

donor from whom the specimen was collected. The following minimum

precautions shall be taken to ensure that unadulterated specimens are

obtained and correctly identified:

(1) To deter the dilution of specimens at the collection site,

toilet bluing agents shall be placed in toilet tanks wherever possible,

so the reservoir of water in the toilet bowl always remains blue. There

shall be no other source of water (e.g., no shower or sink) in the

enclosure where urination occurs.

(2) When a donor arrives at the collection site, the collection

site person shall request the donor to present photo identification. If

the donor does not have proper photo identification, the collection

site person shall contact the supervisor of the donor, the coordinator

of the drug testing program, or any other agency official who can

positively identify the donor. If the donor's identity cannot be

established, the collection site person shall not proceed with the

collection.

(3) If the donor fails to arrive at the assigned time, the

collection site person shall contact the appropriate authority to

obtain guidance on the action to be taken.

(4) The collection site person shall ask the donor to remove any

unnecessary outer garments such as a coat or jacket that might conceal

items or substances that could be used to tamper with or adulterate the

donor's urine specimen. The collection site person shall ensure that

all personal belongings such as a purse or briefcase remain with the

outer garments. The donor may retain his or her wallet.

(5) The donor shall be instructed to wash and dry his or her hands

prior to urination.

(6) After washing hands, the donor shall remain in the presence of

the collection site person and shall not have access to any water

fountain, faucet, soap dispenser, cleaning agent, or any other

materials which could be used to adulterate the specimen.

(7) The collection site person shall give the donor a clean

specimen bottle or specimen container. The donor may provide his/her

specimen in the privacy of a stall or otherwise partitioned area that

allows for individual privacy.

(8) The collection site person shall note any unusual behavior or

appearance on the specimen chain of custody form.

(9) In the exceptional event that an agency-designated collection

site is not accessible and there is an immediate requirement for

specimen collection (e.g., an accident investigation), a public rest

room may be used according to the following procedures: A person of the

same gender as the donor shall accompany the donor into the public rest

room which shall be made secure during the collection procedure. If

possible, a toilet bluing agent shall be placed in the bowl and any

accessible toilet tank. The collection site person shall remain in the

rest room, but outside the stall, until the specimen is collected. If

no bluing agent is available to deter specimen dilution, the collection

site person shall instruct the donor not to flush the toilet until the

specimen is delivered to the collection site person. After the

collection site person has possession of the specimen, the donor will

be instructed to flush the toilet and to participate with the

collection site person in completing the chain of custody procedures.

(10) Upon receiving the specimen from the donor, the collection

site person shall determine the volume of urine in the specimen bottle/

container.

(i) If the volume is greater than 30 milliliters (mL), the

collection site person will proceed with step (11) below.

(ii) If the volume is less than 30 mL and the temperature is within

the acceptable range specified in step (13) below, the specimen is

discarded and a second specimen shall be collected. The donor may be

given a reasonable amount of liquid to drink for this purpose (e.g., an

8 oz glass of water every 30 min, but not to exceed a maximum of 24

oz). If the donor fails for any reason to provide 30 mL of urine for

the second specimen collected, the collection site person shall contact

the appropriate authority to obtain guidance on the action to be taken.

(iii) If the volume is less than 30 mL and the temperature is

outside the acceptable range specified in step (13) below, a second

specimen shall be collected using the procedure specified in step (13)

below.

(11) After the specimen has been provided and submitted to the

collection site person, the donor shall be allowed to wash his or her

hands.

(12) Immediately after the specimen is collected, the collection

site person shall measure only the temperature of the specimen. The

temperature measuring device used must accurately reflect the

temperature of the specimen and not contaminate the specimen. The time

from urination to temperature measurement is critical and in no case

shall exceed 4 minutes.

(13) If the temperature of the specimen is outside the range of

32 deg.-38 deg.C/90 deg.-100 deg.F, that is a reason to believe that

the donor may have altered or substituted the specimen, and another

specimen shall be collected under direct observation of a person of the

same gender and both specimens shall be forwarded to the laboratory for

testing. The agency shall select the observer if there is no collection

site person of the same gender available. A donor may volunteer to have

his or her oral temperature taken to provide evidence to counter the

reason to believe the donor may have altered or substituted the

specimen caused by the specimen's temperature falling outside the

prescribed range.

(14) Immediately after the specimen is collected, the collection

site person shall also inspect the specimen to determine its color and

look for any signs of contaminants. Any unusual findings shall be noted

on the specimen chain of custody form.

(15) All specimens suspected of being adulterated or diluted shall

be forwarded to the laboratory for testing.

(16) When there is any reason to believe that a donor may have

altered or substituted the specimen to be provided, another specimen

shall be obtained as soon as possible under the direct observation of a

person of the same gender and both specimens shall be forwarded to the

laboratory for testing. The agency shall select the observer if there

is no collection site person of the same gender available.

(17) Both the donor and the collection site person shall keep the

specimen bottle/container in view at all times prior to its being

sealed and labeled. If the specimen is transferred from a specimen

container to a specimen bottle, the collection site person shall

request the donor to observe the transfer of the specimen and the

placement of the tamper-evident seal/tape on the bottle. The tamper-

evident seal may be in the form of evidence tape, a self-sealing bottle

cap with both a tamper-evident seal and unique coding, cap and bottle

systems that can only be sealed one time, or any other system that

ensures any tampering with the specimen will be evident to laboratory

personnel during the accessioning process.

(18) The collection site person and the donor shall be present at

the same time during procedures outlined in paragraphs (f)(19)-(f)(22)

of this section.

(19) The collection site person shall place securely on the

specimen bottle an identification label which contains the date, the

donor's specimen number, and any other identifying information provided

or required by the agency.

(20) The donor shall initial the identification label on the

specimen bottle for the purpose of certifying that it is the specimen

collected from him or her.

(21) The collection site person shall enter on the specimen chain

of custody form all information identifying the specimen.

(22) The donor shall be asked to read and sign a statement on the

specimen chain of custody form certifying that the specimen identified

as having been collected from him or her is in fact that specimen he or

she provided.

(23) Based on a reason to believe that the donor may alter or

substitute the specimen to be provided, a higher level supervisor shall

review and concur in advance with any decision by a collection site

person to obtain a specimen under direct observation. The person

directly observing the specimen collection shall be of the same gender.

The agency shall select the observer if there is no collection site

person of the same gender available.

(24) The collection site person shall complete the specimen chain

of custody form.

(25) The urine specimen and specimen chain of custody form are now

ready for shipment. If the specimen is not immediately prepared for

shipment, it shall be appropriately safeguarded during temporary

storage.

(26) While any part of the above chain of custody procedures is

being performed, it is essential that the urine specimen and custody

documents be under the control of the involved collection site person.

If the involved collection site person leaves his or her work station

momentarily, the urine specimen and specimen chain of custody form

shall be taken with him or her or shall be secured. After the

collection site person returns to the work station, the custody process

will continue. If the collection site person is leaving for an extended

period of time, the specimen shall be packaged for mailing before he or

she leaves the site.

(g) Collection Control. To the maximum extent possible, collection

site personnel shall keep the donor's specimen bottle within sight both

before and after the donor has urinated. After the specimen is

collected, it shall be properly sealed and labeled. A specimen chain of

custody form shall be used for maintaining control and accountability

of each specimen. The date and purpose shall be documented on a

specimen chain of custody form each time a specimen is handled or

transferred and every individual in the chain shall be identified.

Every effort shall be made to minimize the number of persons handling

specimens.

(h) Split Specimens. An agency may, but is not required to, use a

split specimen method of collection. If the urine specimen is split

into two specimen bottles (hereinafter referred to as Bottle A and

Bottle B) the following procedure shall be used:

(1) The donor shall urinate into either a specimen bottle or

specimen container. The collection site person, in the presence of the

donor, after determining specimen temperature, pours the urine into two

specimen bottles that are labeled Bottle A and Bottle B or, if Bottle A

was used to collect the specimen, pours an appropriate amount into

Bottle B. A minimum of 45 mL of urine is required when using a split

specimen procedure, i.e., 30 mL for Bottle A and 15 mL for Bottle B.

(2) The Bottle A specimen, containing a minimum of 30 mL of urine,

is to be used for the drug test. If there is no additional urine

available for the second specimen bottle (Bottle B), the first specimen

bottle (Bottle A) shall nevertheless be processed for testing.

(3) A minimum of 15 mL of urine shall be poured into the second

specimen bottle (Bottle B).

(4) All requirements of this part shall be followed with respect to

Bottle A and Bottle B, including the requirements that a copy of the

chain of custody form accompany each bottle processed under split

sample procedures.

(5) The collection site shall send the split specimens (Bottle A

and Bottle B) at the same time to the laboratory that will be testing

the Bottle A specimen.

(6) If the test of the first specimen bottle (Bottle A) is verified

positive by the MRO, the MRO shall report the result to the agency.

Only the donor may request through the MRO that the second specimen

bottle (Bottle B) be tested in an HHS-certified laboratory for presence

of the drug(s) for which a positive result was obtained in the test of

the first specimen bottle (Bottle A). The MRO shall honor such a

request if it is made within 72 hours of the donor's having received

notice that he or she tested positive. The result of this test is

transmitted to the MRO without regard to the cutoff levels used to test

the first specimen bottle (Bottle A).

(7) Any action taken by a Federal agency as a result of an MRO

verified positive drug test (e.g., removal from performing a safety-

sensitive function) may proceed whether Bottle B is or is not tested.

(8) If the result of the test on the second specimen bottle (Bottle

B) fails to reconfirm the result reported for Bottle A, the MRO shall

void the test result for Bottle A and the donor shall re-enter the

group subject to random testing as if the test had not been conducted.

The MRO shall notify the Federal agency when a failed to reconfirm has

occurred and the agency shall contact the Secretary. The Secretary will

investigate the failed to reconfirm result and attempt to determine the

reason for the inconsistent results between Bottle A and Bottle B. HHS

will report its findings to the agency including recommendations and/or

actions taken to prevent the recurrence of the failed to reconfirm

result.

(i) Transportation to Laboratory. Collection site personnel shall

arrange to ship the collected specimens to the drug testing laboratory.

The specimens shall be placed in containers designed to minimize the

possibility of damage during shipment, for example, specimen boxes or

padded mailers; and those containers shall be securely sealed to

eliminate the possibility of undetected tampering. The collection site

personnel shall ensure that the specimen chain of custody form is

enclosed within each container sealed for shipment to the drug testing

laboratory. Since specimens are sealed in packages that would indicate

any tampering during transit to the laboratory and couriers, express

carriers, and postal service personnel do not have access to the chain

of custody forms, there is no requirement that such personnel document

chain of custody for the package during transit.

Section 2.3 Laboratory Personnel

(a) Day-to-Day Management. (1) The laboratory shall have a

responsible person (RP) to assume professional, organizational,

educational, and administrative responsibility for the laboratory's

urine drug testing facility.

(2) This individual shall have documented scientific qualifications

in analytical forensic toxicology. Minimum qualifications are:

(i) Certification as a laboratory director by the State in forensic

or clinical laboratory toxicology; or

(ii) A Ph.D. in one of the natural sciences with an adequate

undergraduate and graduate education in biology, chemistry, and

pharmacology or toxicology; or

(iii) Training and experience comparable to a Ph.D. in one of the

natural sciences, such as a medical or scientific degree with

additional training and laboratory/research experience in biology,

chemistry, and pharmacology or toxicology; and

(iv) In addition to the requirements in (i), (ii), and (iii) above,

minimum qualifications also require:

(A) Appropriate experience in analytical forensic toxicology

including experience with the analysis of biological material for drugs

of abuse, and

(B) Appropriate training and/or experience in forensic applications

of analytical toxicology, e.g., publications, court testimony, research

concerning analytical toxicology of drugs of abuse, or other factors

which qualify the individual as an expert witness in forensic

toxicology.

(3) This individual shall be engaged in and responsible for the

day-to-day management of the drug testing laboratory even where another

individual has overall responsibility for an entire multispeciality

laboratory.

(4) This individual shall be responsible for ensuring that there

are enough personnel with adequate training and experience to supervise

and conduct the work of the drug testing laboratory. He or she shall

assure the continued competency of laboratory personnel by documenting

their inservice training, reviewing their work performance, and

verifying their skills.

(5) This individual shall be responsible for the laboratory's

having a procedure manual which is complete, up-to-date, available for

personnel performing tests, and followed by those personnel. The

procedure manual shall be reviewed, signed, and dated by this

responsible person whenever procedures are first placed into use or

changed or when a new individual assumes responsibility for management

of the drug testing laboratory. Copies of all procedures and dates on

which they are in effect shall be maintained. (Specific contents of the

procedure manual are described in section 2.4(n)(1))

(6) This individual shall be responsible for maintaining a quality

assurance program to assure the proper performance and reporting of all

test results; for maintaining acceptable analytical performance for all

controls and standards; for maintaining quality control testing; and

for assuring and documenting the validity, reliability, accuracy,

precision, and performance characteristics of each test and test

system.

(7) This individual shall be responsible for taking all remedial

actions necessary to maintain satisfactory operation and performance of

the laboratory in response to quality control systems not being within

performance specifications, errors in result reporting or in analysis

of performance testing results. This individual shall ensure that

sample results are not reported until all corrective actions have been

taken and he or she can assure that the results provided are accurate

and reliable.

(b) Certifying Test Results. The laboratory's urine drug testing

facility shall have a certifying scientist(s), as defined in section

1.2, who reviews all pertinent data and quality control results in

order to attest to the validity of the laboratory's test reports. A

laboratory may designate certifying scientists that are qualified to

certify only results that are negative on the initial test and

certifying scientists that are qualified to certify both initial and

confirmatory tests.

(c) Day-to-Day Operations and Supervision of Analysts. The

laboratory's urine drug testing facility shall have an individual(s) to

be responsible for day-to-day operations and to supervise the technical

analysts. This individual(s) shall have at least a bachelor's degree in

the chemical or biological sciences or medical technology or

equivalent. He or she shall have training and experience in the theory

and practice of the procedures used in the laboratory, resulting in his

or her thorough understanding of quality control practices and

procedures; the review, interpretation, and reporting of test results;

maintenance of chain of custody; and proper remedial actions to be

taken in response to test systems being out of control limits or

detecting aberrant test or quality control results.

(d) Other Personnel. Other technicians or nontechnical staff shall

have the necessary training and skills for the tasks assigned.

(e) Training. The laboratory's urine drug testing program shall

make available continuing education programs to meet the needs of

laboratory personnel.

(f) Files. Laboratory personnel files shall include: resume of

training and experience; certification or license, if any; references;

job descriptions; records of performance evaluation and advancement;

incident reports; and results of tests which establish employee

competency for the position he or she holds, such as a test for color

blindness, if appropriate.

Section 2.4 Laboratory Analysis Procedures

(a) Security and Chain of Custody. (1) Drug testing laboratories

shall be secure at all times. They shall have in place sufficient

security measures to control access to the premises and to ensure that

no unauthorized personnel handle specimens or gain access to the

laboratory processes or to areas where records are stored. Access to

these secured areas shall be limited to specifically authorized

individuals whose authorization is documented. With the exception of

personnel authorized to conduct inspections on behalf of Federal

agencies for which the laboratory is engaged in urine testing or on

behalf of the Secretary or emergency personnel (e.g., firefighters and

medical rescue teams), all authorized visitors and maintenance and

service personnel shall be escorted at all times. The laboratory shall

maintain a record that documents the dates, time of entry and exit, and

purpose of entry of authorized visitors, maintenance, and service

personnel accessing secured areas.

(2) Laboratories shall use chain of custody procedures to maintain

control and accountability of specimens from receipt through completion

of testing, reporting of results, during storage, and continuing until

final disposition of specimens. The date and purpose shall be

documented on an appropriate chain of custody form each time a specimen

is handled or transferred, and every individual in the chain shall be

identified. Accordingly, authorized technicians shall be responsible

for each urine specimen or aliquot in their possession and shall sign

and complete chain of custody forms for those specimens or aliquots as

they are received.

(b) Receiving. (1) When a shipment of specimens is received,

laboratory personnel shall inspect each package for evidence of

possible tampering and compare information on specimen bottles within

each package to the information on the accompanying chain of custody

forms. Any direct evidence of tampering or discrepancies in the

information on specimen bottles and the specimen chain of custody forms

attached to the shipment shall be immediately reported to the agency

and shall be noted on the specimen chain of custody forms which shall

accompany the specimens while they are in the laboratory's possession.

(2) Specimen bottles will normally be retained within the

laboratory's accession area until all analyses have been completed.

Aliquots and laboratory chain of custody forms shall be used by

laboratory personnel for conducting initial and confirmatory tests

while the original specimen and specimen chain of custody form remain

in secure storage.

(c) Short-Term Refrigerated Storage. Specimens that do not receive

an initial test within 7 days of arrival at the laboratory shall be

placed in secure refrigeration units. Temperatures shall not exceed

6 deg.C. Emergency power equipment shall be available in case of

prolonged power failure.

(d) Specimen Processing. Laboratory facilities for urine drug

testing will normally process specimens by grouping them into batches.

The number of specimens in each batch may vary significantly depending

on the size of the laboratory and its workload. When conducting either

initial or confirmatory tests, every batch shall satisfy the quality

control requirements in sections 2.5 (b) and (c), respectively.

(e) Initial Test. (1) The initial test shall use an immunoassay

which meets the requirements of the Food and Drug Administration for

commercial distribution. The following initial cutoff levels shall be

used when screening specimens to determine whether they are negative

for these five drugs or classes of drugs:

------------------------------------------------------------------------

Initial

test

level (ng/

mL)

------------------------------------------------------------------------

Marijuana metabolites........................................ 50

Cocaine metabolites.......................................... 300

Opiate metabolites........................................... \1\300

Phencyclidine................................................ 25

Amphetamines................................................. 1,000

------------------------------------------------------------------------

\1\25 ng/mL if immunoassay specific for free morphine.

(2) These test levels are subject to change by the Department of

Health and Human Services as advances in technology or other

considerations warrant identification of these substances at other

concentrations. The agency requesting the authorization to include

other drugs shall submit to the Secretary in writing the agency's

proposed initial test methods, testing levels, and proposed performance

test program.

(3) Specimens that test negative on all initial immunoassay tests

will be reported negative. No further testing of these negative

specimens for drugs is permitted and the specimens shall either be

discarded or pooled for use in the laboratory's internal quality

control program.

(4) Multiple initial tests (also known as rescreening) for the same

drug or drug class may be performed provided that all tests meet all

Guideline cutoffs and quality control requirements (see section

2.5(b)). Examples: a test is performed by immunoassay technique ``A''

for all drugs using the HHS cutoff levels, but presumptive positive

amphetamines are forwarded for immunoassay technique ``B'' to eliminate

any possible presumptive positives due to structural analogues; a valid

analytical result cannot be obtained using immunoassay technique ``A''

and immunoassay technique ``B'' is used in an attempt to obtain a valid

analytical result.

(f) Confirmatory Test. (1) All specimens identified as positive on

the initial test shall be confirmed for the class(es) of drugs screened

positive on the initial test using gas chromatography/mass spectrometry

(GC/MS) at the cutoff values listed in this paragraph. All

confirmations shall be by quantitative analysis. Concentrations which

exceed the linear region of the standard curve shall be documented in

the laboratory record as ``exceeds the linear range of the test.''

------------------------------------------------------------------------

Confirmatory

test level

(ng/mL)

------------------------------------------------------------------------

Marijuana metabolite\1\................................... 15

Cocaine metabolite\2\..................................... 150

Opiates:

Morphine................................................ 300

Codeine................................................. 300

Phencyclidine............................................. 25

Amphetamines:

Amphetamine............................................. 500

Methamphetamine\3\...................................... 500

------------------------------------------------------------------------

\1\Delta-9-tetrahydrocannabinol-9-carboxylic acid.

\2\Benzoylecgonine.

\3\Specimen must also contain amphetamine at a concentration

200 ng/mL.

(2) These test levels are subject to change by the Department of

Health and Human Services as advances in technology or other

considerations warrant identification of these substances at other

concentrations. The agency requesting the authorization to include

other drugs shall submit to the Secretary in writing the agency's

proposed confirmatory test methods, testing levels, and proposed

performance test program.

(3) Specimens that test negative on confirmatory tests shall be

reported negative. No further testing of these specimens for drugs is

permitted and the specimens shall either be discarded or pooled for use

in the laboratory's internal quality control program.

(g) Reporting Results. (1) The laboratory shall report test results

to the agency's MRO within an average of 5 working days after receipt

of the specimen by the laboratory. Before any test result is reported

(the results of initial tests, confirmatory tests, or quality control

data), it shall be reviewed and the test certified as an accurate

report by a certifying scientist who satisfies the requirements

described by the definition in section 1.2. The report shall identify

the drugs/metabolites tested for, whether positive or negative, and the

cutoff for each, the specimen number assigned by the agency, and the

drug testing laboratory specimen identification number.

(2) Except as otherwise provided by this subsection, the laboratory

shall report as negative all specimens which are negative on the

initial test or negative on the confirmatory test. Only specimens

confirmed positive shall be reported positive for a specific drug. For

amphetamines, to report a specimen positive for methamphetamine only,

the specimen must also contain amphetamine at a concentration equal to

or greater than 200 ng/mL by the confirmatory test. If this criterion

is not met, the specimen must be reported as negative for

methamphetamine.

(3) The MRO may request from the laboratory and the laboratory

shall provide quantitation of test results. The MRO may not disclose

quantitation of test results to the agency but shall report only

whether the test was positive or negative.

(4) The laboratory may transmit results to the MRO by various

electronic means (for example, teleprinters, facsimile, or computer) in

a manner designed to ensure confidentiality of the information. Results

may not be provided verbally by telephone. The laboratory must ensure

the security of the data transmission and limit access to any data

transmission, storage, and retrieval system.

(5) The laboratory shall send only to the MRO a certified copy of

the original chain of custody form signed by a certifying scientist.

(6) The laboratory shall provide to the agency official responsible

for coordination of the drug-free workplace program a monthly

statistical summary of urinalysis testing of Federal employees and

shall not include in the summary any personal identifying information.

Initial and confirmation data shall be included from test results

reported within that month. Normally this summary shall be forwarded by

registered or certified mail not more than 14 calendar days after the

end of the month covered by the summary. The summary shall contain the

following information:

Initial Testing:

(i) Number of specimens received;

(ii) Number of specimens reported out; and

(iii) Number of specimens screened positive for: Marijuana

metabolites, Cocaine metabolites, Opiate metabolites, Phencyclidine,

and Amphetamines.

Confirmatory Testing:

(i) Number of specimens received for confirmation;

(ii) Number of specimens confirmed positive for: Marijuana

metabolite, Cocaine metabolite, Morphine, codeine, Phencyclidine,

Amphetamine, and Methamphetamine. (7) The laboratory shall make

available copies of all analytical results for Federal drug testing

programs when requested by HHS or any Federal agency for which the

laboratory is performing drug testing services.

(8) Unless otherwise instructed by the agency in writing, all

records pertaining to a given urine specimen shall be retained by the

drug testing laboratory for a minimum of 2 years.

(h) Long-Term Storage. Long-term frozen storage (-20 deg.C or

less) ensures that positive urine specimens will be available for any

necessary retest. Unless otherwise authorized in writing by the agency,

drug testing laboratories shall retain and place in properly secured

long-term frozen storage for a minimum of 1 year all specimens

confirmed positive. Within this 1-year period an agency may request the

laboratory to retain the specimen for an additional period of time. If

no such request is received, the laboratory may discard the specimen

after the end of 1 year, except that the laboratory shall be required

to maintain any specimens under legal challenge for an indefinite

period.

(i) Retesting of a Specimen (i.e., the reanalysis by gas

chromatography/mass spectrometry of a specimen previously reported

positive or the testing of Bottle B of a split specimen collection).

Because some analytes deteriorate or are lost during freezing and/or

storage, quantitation for a retest is not subject to a specific cutoff

requirement but must provide data sufficient to confirm the presence of

the drug or metabolite.

(j) Subcontracting. Drug testing laboratories shall not subcontract

and shall perform all work with their own personnel and equipment

unless otherwise authorized by the agency. The laboratory must be

capable of performing testing for the five classes of drugs (marijuana,

cocaine, opiates, phencyclidine, and amphetamines) using the initial

immunoassay and confirmatory GC/MS methods specified in these

Guidelines.

(k) Laboratory Facilities. (1) Laboratory facilities shall comply

with applicable provisions of any State licensure requirements.

(2) Laboratories certified in accordance with Subpart C of these

Guidelines shall have the capability, at the same laboratory premises,

of performing initial and confirmatory tests for each drug or

metabolite for which service is offered.

(l) Inspections. The Secretary, any Federal agency utilizing the

laboratory, or any organization performing laboratory certification on

behalf of the Secretary may reserve the right to inspect the laboratory

at any time. Agency contracts with laboratories for drug testing, as

well as contracts for collection site services, shall permit the agency

to conduct unannounced inspections. In addition, prior to the award of

a contract the agency may carry out preaward inspections and evaluation

of the procedural aspects of the laboratory's drug testing operation.

(m) Documentation. The drug testing laboratories shall maintain and

make available for at least 2 years documentation of all aspects of the

testing process. This 2-year period may be extended upon written

notification by HHS or by any Federal agency for which laboratory

services are being provided. The required documentation shall include

personnel files on all individuals authorized to have access to

specimens; chain of custody forms; quality assurance/quality control

records; procedure manuals; all test data (including calibration curves

and any calculations used in determining test results); reports;

performance records on performance testing; performance on

certification inspections; and hard copies of computer-generated data.

The laboratory shall be required to maintain documents for any specimen

under legal challenge for an indefinite period.

(n) Additional Requirements for Certified Laboratories.

(1) Procedure Manual. Each laboratory shall have a procedure manual

which includes the principles of each test, preparation of reagents,

standards and controls, calibration procedures, derivation of results,

linearity of methods, sensitivity of the methods, cutoff values,

mechanisms for reporting results, controls, criteria for unacceptable

specimens and results, remedial actions to be taken when the test

systems are outside of acceptable limits, reagents and expiration

dates, and references. Copies of all procedures and dates on which they

are in effect shall be maintained as part of the manual.

(2) Calibrators and Controls. Laboratory calibrators and controls

shall be prepared using pure drug reference materials, stock standard

solutions obtained from other laboratories, or standard solutions

obtained from commercial manufacturers. The calibrators and controls

shall be properly labeled as to content and concentration. The

standards (e.g., pure reference materials, stock standard solutions,

purchased standards) shall be labeled with the following dates: When

received (if applicable); When prepared or opened; when placed in

service; and expiration date.

(3) Instruments and Equipment. (i) Volumetric pipettes and

measuring devices shall be certified for accuracy or be checked by

gravimetric, colorimetric, or other verification procedure. Automatic

pipettes and dilutors shall be checked for accuracy and reproducibility

before being placed in service and checked periodically thereafter.

(ii) There shall be written procedures for instrument set-up and

normal operation, a schedule for checking critical operating

characteristics for all instruments, tolerance limits for acceptable

function checks, and instructions for major troubleshooting and repair.

Records shall be available on preventive maintenance.

(4) Remedial Actions. There shall be written procedures for the

actions to be taken when systems are out of acceptable limits or errors

are detected. There shall be documentation that these procedures are

followed and that all necessary corrective actions are taken. There

shall also be in place systems to verify all stages of testing and

reporting and documentation that these procedures are followed.

(5) Personnel Available to Testify at Proceedings. A laboratory

shall have qualified personnel available to testify in an

administrative or disciplinary proceeding against a Federal employee

when that proceeding is based on positive urinalysis results reported

by the laboratory.

(6) Restrictions. The laboratory shall not enter into any

relationship with an agency's MRO that may be construed as a potential

conflict of interest or derive any financial benefit by having an

agency use a specific MRO.

Section 2.5 Quality Assurance and Quality Control

(a) General. Drug testing laboratories shall have a quality

assurance program which encompasses all aspects of the testing process

including but not limited to specimen acquisition, chain of custody,

security and reporting of results, initial and confirmatory testing,

certification of calibrators and controls, and validation of analytical

procedures. Quality assurance procedures shall be designed,

implemented, and reviewed to monitor the conduct of each step of the

testing process.

(b) Laboratory Quality Control Requirements for Initial Tests. Each

analytical run of specimens to be screened shall include:

(1) Sample(s) certified to contain no drug (i.e., negative urine

samples);

(2) Positive control(s) fortified with drug or metabolite;

(3) At least one positive control with the drug or metabolite at or

near the threshold (cutoff);

(4) A sufficient number of calibrators to ensure and document the

linearity of the assay method over time in the concentration area of

the cutoff. After acceptable values are obtained for the known

calibrators, those values will be used to calculate sample data;

(5) A minimum of 10 percent of the total specimens and quality

control samples in each analytical run shall be quality control

samples; and

(6) One percent of each run, with a minimum of at least one sample,

shall be the laboratory's blind quality control samples to appear as

normal samples to the laboratory analysts.

Implementation of procedures to ensure that carryover does not

contaminate the testing of an donor's specimen shall be documented.

(c) Laboratory Quality Control Requirements for Confirmation Tests.

Each analytical run of specimens to be confirmed shall include:

(1) Sample(s) certified to contain no drug (i.e., negative urine

samples);

(2) Positive calibrator(s) and control(s) fortified with drug or

metabolite; and

(3) At least one positive control with the drug or metabolite at or

near the threshold (cutoff).

The linearity and precision of the method shall be periodically

documented. Implementation of procedures to ensure that carryover does

not contaminate the testing of a donor's specimen shall also be

documented.

(d) Agency Blind Sample Program.

(1) Agencies shall only purchase blind quality control materials

that: (a) have been certified by immunoassay and GC/MS and (b) have

stability data which verifies those materials' performance over time.

(2) During the initial 90-day period of any new drug testing

program, each agency shall submit blind performance test samples to

each laboratory it contracts with in the amount of at least 20 percent

of the total number of specimens submitted (up to a maximum of 200

blind samples) and thereafter a minimum of 3 percent blind samples (up

to a maximum of 100 blind samples) submitted per quarter.

(3) Approximately 80 percent of the blind quality control samples

shall be negative (i.e., certified to contain no drug) and the

remaining samples shall be positive for one or more drugs per sample in

a distribution such that all the drugs to be tested are included in

approximately equal frequencies of challenge. The positive samples

shall be spiked only with those drugs for which the agency is testing.

(4) The agency shall investigate any unsatisfactory blind

performance test sample results and submit its findings to the

Secretary. The Secretary shall continue the investigation to ensure

that the laboratory has corrected the cause of the unsatisfactory

performance test result. A report of the Secretary's investigative

findings and the corrective action taken by the laboratory shall be

sent to the agency contracting officer. The Secretary shall ensure

notification of the finding to all other Federal agencies for which the

laboratory is engaged in urine drug testing and coordinate any

necessary action.

(5) Should a false positive error occur on a blind performance test

sample and the error is determined to be an administrative error

(clerical, sample mixup, etc.), the Secretary shall require the

laboratory to take corrective action to minimize the occurrence of the

particular error in the future; and, if there is reason to believe the

error could have been systematic, the Secretary may also require review

and reanalysis of previously run specimens.

(6) Should a false positive error occur on a blind performance test

sample and the error is determined to be a technical or methodological

error, the laboratory shall submit all quality control data from the

batch of specimens which included the false positive specimen. In

addition, the laboratory shall retest all specimens analyzed positive

for that drug or metabolite from the time of final resolution of the

error back to the time of the last satisfactory performance test cycle.

This retesting shall be documented by a statement signed by the

Responsible Person. The Secretary may require an on-site review of the

laboratory which may be conducted unannounced during any hours of

operation of the laboratory. The Secretary has the option of revoking

(section 3.13) or suspending (section 3.14) the laboratory's

certification or recommending that no further action be taken if the

case is one of less serious error in which corrective action has

already been taken, thus reasonably assuring that the error will not

occur again.

Section 2.6 Reporting and Review of Results

(a) Medical Review Officer Shall Review Results. An essential part

of the drug testing program is the final review of results. A positive

test result does not automatically identify an employee/applicant as an

illegal drug user. An individual with a detailed knowledge of possible

alternate medical explanations is essential to the review of results.

This review shall be performed by the MRO prior to the transmission of

results to agency administrative officials.

(b) Medical Review Officer--Qualifications and Responsibilities.

The MRO shall be a licensed physician with knowledge of substance abuse

disorders. The MRO may be an employee of the agency or a contractor for

the agency; however, the MRO shall not be an employee or agent of or

have any financial interest in the laboratory for which the MRO is

reviewing drug testing results. Additionally, the MRO shall not derive

any financial benefit by having an agency use a specific drug testing

laboratory or have any agreement with the laboratory that may be

construed as a potential conflict of interest. The role of the MRO is

to review and interpret positive test results obtained through the

agency's testing program. In carrying out this responsibility, the MRO

shall examine alternate medical explanations for any positive test

result. This action could include conducting a medical interview with

the donor, review of the donor's medical history, or review of any

other relevant biomedical factors. The MRO shall review all medical

records made available by the donor when a confirmed positive test

could have resulted from legally prescribed medication. The MRO shall

not, however, consider the results of urine specimens that are not

obtained or processed in accordance with these Guidelines.

(c) Positive Test Result. Prior to making a final decision to

verify a positive test result, the MRO shall give the donor an

opportunity to discuss the test result with him or her. Following

verification of a positive test result, the MRO shall report the result

to the agency's official designated to receive results.

(d) Verification for Opiates; Review for Prescription Medication.

Before the MRO verifies a confirmed positive result for opiates, he or

she shall determine that there is clinical evidence--in addition to the

urine test--of illegal use of any opium, opiate, or opium derivative

(e.g., morphine/codeine) listed in Schedule I or II of the Controlled

Substances Act. This requirement does not apply if the confirmatory

procedure for opiates confirms the presence of 6-monoacetylmorphine

since the presence of this metabolite is proof of heroin use.

(e) Reanalysis Authorized. Should any question arise as to the

accuracy or validity of a positive test result, only the MRO is

authorized to order a retest of a single specimen or the Bottle A

specimen from a split specimen collection. Such retests are authorized

only at laboratories certified under these Guidelines.

(f) Result Consistent With Legal Drug Use. If the MRO determines

there is a legitimate medical explanation for the positive test result,

he or she shall take no further action and report the test result as

negative.

(g) Result Scientifically Insufficient. Additionally, the MRO,

based on review of inspection reports, quality control data, and other

pertinent results, may determine that the result is scientifically

insufficient for further action and declare the test specimen negative.

In this situation the MRO may request a retest of the original specimen

before making this decision. (The MRO may request that the retest be

performed by the same laboratory or, as provided in section 2.6(e),

that an aliquot of the original specimen be sent for a retest to an

alternate laboratory which is certified in accordance with these

Guidelines.) The laboratory shall assist in this review process as

requested by the MRO by making available the individual responsible for

day-to-day management of the urine drug testing laboratory or other

employee who is a forensic toxicologist or who has equivalent forensic

experience in urine drug testing, to provide specific consultation as

required by the agency. The MRO shall report to the Secretary all

negative findings based on scientific insufficiency but shall not

include any personal identifying information in such reports.

(h) Reporting Final Results. The MRO shall report the final results

of the drug tests in writing and in a manner designed to ensure

confidentiality of the information.

Section 2.7 Protection of Employee Records

Consistent with 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104, all

laboratory contracts shall require that the contractor comply with the

Privacy Act, 5 U.S.C. 522a. In addition, laboratory contracts shall

require compliance with patient access and confidentiality provisions

of section 503 of Public Law 100-71. The agency shall establish a

Privacy Act System of Records or modify an existing system, or use any

applicable Government-wide system of records to cover both the agency's

and the laboratory's records of employee urinalysis results. The

contract and the Privacy Act System of Records shall specifically

require that employee records be maintained and used with the highest

regard for employee privacy.

Section 2.8 Individual Access to Test and Laboratory Certification

Results

In accordance with section 503 of Public Law 100-71, any Federal

employee who is the subject of a drug test shall, upon written request,

have access to any records relating to his or her drug test and any

records relating to the results of any relevant certification, review,

or revocation-of-certification proceedings.

Subpart C--Certification of Laboratories Engaged in Urine Drug Testing

for Federal Agencies

Section 3.1 Introduction

Urine drug testing is a critical component of efforts to combat

drug abuse in our society. Many laboratories are familiar with good

laboratory practices but may be unfamiliar with the special procedures

required when drug test results are used in the employment context.

Accordingly, the following are minimum standards to certify

laboratories engaged in urine drug testing for Federal agencies.

Certification, even at the highest level, does not guarantee accuracy

of each result reported by a laboratory conducting urine drug testing

for Federal agencies. Therefore, results from laboratories certified

under these Guidelines must be interpreted with a complete

understanding of the total collection, analysis, and reporting process

before a final conclusion is made.

Section 3.2 Goals and Objectives of Certification

(a) Uses of Urine Drug Testing. Urine drug testing is an important

tool to identify drug users in a variety of settings. In the proper

context, urine drug testing can be used to deter drug abuse in general.

To be a useful tool, the testing procedure must be capable of detecting

drugs or their metabolites at concentrations indicated in sections

2.4(e) and 2.4(f).

(b) Need to Set Standards; Inspections. Reliable discrimination

between the presence, or absence, of specific drugs or their

metabolites is critical, not only to achieve the goals of the testing

program but to protect the rights of the Federal employees being

tested. Thus, standards have been set which laboratories engaged in

Federal employee urine drug testing must meet in order to achieve

maximum accuracy of test results. These laboratories will be evaluated

by the Secretary or the Secretary's designee as defined in section 1.2

in accordance with these Guidelines. The qualifying evaluation will

involve three rounds of performance testing plus an on-site inspection.

Maintenance of certification requires participation in a quarterly

performance testing program plus periodic, on-site inspections. One

inspection following successful completion of a performance testing

regimen is required for initial certification. This must be followed by

a second inspection within 3 months, after which biannual inspections

will be required to maintain certification.

(c) Urine Drug Testing Applies Analytical Forensic Toxicology. The

possible impact of a positive test result on an individual's livelihood

or rights, together with the possibility of a legal challenge of the

result, sets this type of test apart from most clinical laboratory

testing. In fact, urine drug testing should be considered a special

application of analytical forensic toxicology. That is, in addition to

the application of appropriate analytical methodology, the specimen

must be treated as evidence, and all aspects of the testing procedure

must be documented and available for possible court testimony.

Laboratories engaged in urine drug testing for Federal agencies will

require the services and advice of a qualified forensic toxicologist,

or individual with equivalent qualifications (both training and

experience) to address the specific needs of the Federal drug testing

program, including the demands of chain of custody of specimens,

security, proper documentation of all records, storage of positive

specimens for later or independent testing, presentation of evidence in

court, and expert witness testimony.

Section 3.3 General Certification Requirements

A laboratory must meet all the pertinent provisions of these

Guidelines in order to qualify for and maintain certification under

these standards.

Section 3.4 Capability to Test for Five Classes of Drugs

To be certified, a laboratory must be capable of testing for at

least the following five classes of drugs: marijuana, cocaine, opiates,

amphetamines, and phencyclidine using the initial immunoassay and

quantitative confirmatory GC/MS methods specified in these Guidelines.

The certification program will be limited to the five classes of drugs

(sections 2.1(a) (1) and (2)) and the methods (sections 2.4 (e) and

(f)) specified in these Guidelines. The laboratory will be surveyed and

performance tested only for these methods and drugs. Certification of a

laboratory indicates that any test result reported by the laboratory

for the Federal Government meets the standards in these Guidelines for

the five classes of drugs using the methods specified. Certified

laboratories must clearly inform all unregulated, private clients when

their specimens are being tested using procedures that are different

from those for which the laboratory is certified (i.e., testing

specimens not under the Guidelines).

Section 3.5 Initial and Confirmatory Capability at Same Site

Certified laboratories shall have the capability, at the same

laboratory site, of performing both initial immunoassays and

confirmatory GC/MS tests (sections 2.4 (e) and (f)) for marijuana,

cocaine, opiates, amphetamines, and phencyclidine and for any other

drug or metabolite for which agency drug testing is authorized

(sections 2.1(a) (1) and (2)). All positive initial test results shall

be confirmed prior to reporting them.

Section 3.6 Personnel

Laboratory personnel shall meet the requirements specified in

section 2.3 of these Guidelines. These Guidelines establish the

exclusive standards for qualifying or certifying those laboratory

personnel involved in urinalysis testing whose functions are prescribed

by these Guidelines. A certification of a laboratory under these

Guidelines shall be a determination that these qualification

requirements have been met.

Section 3.7 Quality Assurance and Quality Control

Drug testing laboratories shall have a quality assurance program

which encompasses all aspects of the testing process, including but not

limited to specimen acquisition, chain of custody, security and

reporting of results, initial and confirmatory testing, and validation

of analytical procedures. Quality control procedures shall be designed,

implemented, and reviewed to monitor the conduct of each step of the

process of testing for drugs as specified in section 2.5 of these

Guidelines.

Section 3.8 Security and Chain of Custody

Laboratories shall meet the security and chain of custody

requirements provided in section 2.4(a).

Section 3.9 One-Year Storage for Confirmed Positives

All confirmed positive specimens shall be retained in accordance

with the provisions of section 2.4(h) of these Guidelines.

Section 3.10 Documentation

The laboratory shall maintain and make available for at least 2

years documentation in accordance with the specifications in section

2.4(m).

Section 3.11 Reports

The laboratory shall report test results in accordance with the

specifications in section 2.4(g).

Section 3.12 Certification

(a) General. The Secretary may certify any laboratory that meets

the standards in these Guidelines to conduct urine drug testing. In

addition, the Secretary may consider to be certified any laboratory

that is certified by an HHS-recognized certification program in

accordance with these Guidelines.

(b) Criteria. In determining whether to certify a laboratory or to

accept the certification of an HHS-recognized certification program in

accordance with these Guidelines, the Secretary shall consider the

following criteria:

(1) The adequacy of the laboratory facilities;

(2) The expertise and experience of the laboratory personnel;

(3) The excellence of the laboratory's quality assurance/ quality

control program;

(4) The performance of the laboratory on any performance tests;

(5) The laboratory's compliance with standards as reflected in any

laboratory inspections; and

(6) Any other factors affecting the reliability and accuracy of

drug tests and reporting done by the laboratory.

(c) Corrective Action by Certified Laboratories. A laboratory must

meet all the pertinent provisions of these Guidelines in order to

qualify for and maintain certification. 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 shall have the authority to issue directives

to any laboratory suspending the use of certain analytical procedures

when necessary to protect the integrity of the testing process;

ordering any laboratory to undertake corrective actions to respond to

material deficiencies identified by an inspection or through

proficiency testing; ordering any laboratory to send aliquots of urine

specimens to another 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.

Section 3.13 Revocation

(a) General. The Secretary shall revoke certification of any

laboratory certified under these provisions or accept revocation by an

HHS-recognized certification program in accordance with these

Guidelines if the Secretary determines that revocation is necessary to

ensure the full reliability and accuracy of drug tests and the accurate

reporting of test results.

(b) Factors to Consider. 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; for example, a false positive error in reporting

the results of an employee's drug test;

(2) Unsatisfactory participation in performance evaluations or

laboratory inspections;

(3) A material violation of a certification standard or a contract

term or other condition imposed on the laboratory by a Federal agency

using the laboratory's services;

(4) Conviction for any criminal offense committed as an incident to

operation of the laboratory; or

(5) Any other cause which materially affects the ability of the

laboratory to ensure the full reliability and accuracy of drug tests

and the accurate reporting of results.

(c) Period and Terms. 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 of Federal employees.

Section 3.14 Suspension

(a) Criteria. Whenever the Secretary has reason to believe that

revocation may be required and that immediate action is necessary in

order to protect the interests of the United States and its employees,

the Secretary may immediately suspend a laboratory's certification to

conduct urine drug testing for Federal agencies. The Secretary may also

accept suspension of certification by an HHS-recognized certification

program in accordance with these Guidelines.

(b) Period and Terms. The period and terms of suspension shall be

determined by the Secretary and shall depend upon the facts and

circumstances of the suspension and the need to ensure accurate and

reliable drug testing of Federal employees.

Section 3.15 Notice

(a) Written Notice. When a laboratory is suspended or the Secretary

seeks to revoke certification, the Secretary shall immediately serve

the laboratory with written notice of the suspension or proposed

revocation by facsimile mail, personal service, or registered or

certified mail, return receipt requested. This notice shall state the

following:

(1) The reasons for the suspension or proposed revocation;

(2) The terms of the suspension or proposed revocation; and

(3) The period of suspension or proposed revocation.

(b) Opportunity for Informal Review. The written notice 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 notice,

or if expedited review is requested, within 3 days of the date the

laboratory received the notice. Subpart D contains detailed procedures

to be followed for an informal review of the suspension or proposed

revocation.

(c) Effective Date. A suspension shall be effective immediately. A

proposed revocation shall be effective 30 days after written notice is

given or, if review is requested, upon the reviewing official's

decision to uphold the proposed revocation. If the reviewing official

decides not to uphold the suspension or proposed revocation, the

suspension shall terminate immediately and any proposed revocation

shall not take effect.

(d) HHS-Recognized Certification Program. The Secretary's

responsibility under this section may be carried out by an HHS-

recognized certification program in accordance with these Guidelines.

(e) Public Notice. The Secretary will publish in the Federal

Register the name, address, and telephone number of any laboratory that

has its certification suspended or revoked under section 3.13 or

section 3.14, respectively, and the name of any laboratory which has

its suspension lifted. The Secretary shall provide to any member of the

public upon request the written notice provided to a laboratory that

has its 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 D.

Section 3.16 Recertification

Following revocation, a laboratory may apply for recertification.

Unless otherwise provided by the Secretary in the notice of revocation

under section 3.13(a) or the reviewing official's decision under

section 4.9(e) or 4.14(a), a laboratory which has had its certification

revoked may apply for certification in accordance with this section. In

order to be certified, the laboratory shall meet the criteria of

section 3.12(b), as well as all other requirements of these Guidelines,

including the successful participation in three cycles of performance

testing (sections 3.17(b) and 3.19(a)) and a laboratory inspection

(sections 3.2(b) and 3.20). Once certified, the laboratory must undergo

a second inspection within three months, after which biannual

inspections will be required to maintain certification (section

3.2(b)), as well as participation in the quarterly performance testing

program (sections 3.1(b) and 3.17(c)).

Section 3.17 Performance Testing (PT) Requirement for Certification

(a) An Initial and Continuing Requirement. The PT program is a part

of the initial evaluation of a laboratory seeking certification (both

PT and laboratory inspection are required) and of the continuing

assessment of laboratory performance necessary to maintain this

certification.

(b) Three Initial Cycles Required. Successful participation in

three cycles of testing shall be required before a laboratory is

eligible to be considered for certification.

(c) Four Challenges Per Year. After certification, laboratories

shall be challenged with at least 10 PT samples on a quarterly cycle.

(d) Laboratory Procedures Identical for Performance Test and

Routine Employee Specimens. All procedures associated with the handling

and testing of the PT samples by the laboratory shall to the greatest

extent possible be carried out in a manner identical to that applied to

routine laboratory specimens, unless otherwise specified.

(e) Blind Performance Test. Any certified laboratory shall be

subject to blind PT samples (see section 2.5(d)). Performance on blind

PT samples shall be at the same level as for the open or non-blind PT

samples.

(f) Reporting--Open Performance Test. The laboratory shall report

results of open PT samples to the certifying organization in the same

manner as specified in section 2.4(g)(2) for routine specimens.

Section 3.18 Performance Test Samples Composition

(a) Description of the Drugs. PT samples shall contain those drugs

and metabolites which each certified laboratory must be prepared to

assay in concentration ranges that allow detection of the analytes by

commonly used immunoassay screening techniques. These levels are

generally in the range of concentrations which might be expected in the

urine of recent drug users. For some drug analytes, the sample

composition will consist of the parent drug as well as major

metabolites. In some cases, more than one drug class may be included in

one sample, but generally no more than two drugs will be present in any

one sample in order to imitate the type of specimen which a laboratory

normally encounters. For any particular PT cycle, the actual

composition of kits going to different laboratories will vary but,

within any annual period, all laboratories participating will have

analyzed the same total set of samples.

(b) Concentrations. PT samples (as differentiated from blind

quality control samples) shall be spiked with the drug classes and

their metabolites that are required for certification (marijuana,

cocaine, opiates, amphetamines, and phencyclidine) with concentration

levels set by, but not limited to, one of the following schema: (1) At

least 20 percent above the cutoff limit for either the initial assay or

the confirmatory test, depending on which is to be evaluated; (2) below

the cutoff limit as retest samples (for GC/MS quantitation); and, (3)

below the cutoff limit for special purposes. Some PT samples may be

identified for GC/MS assay only (retest samples). Blanks shall contain

less than 2 ng/mL of any of the target drugs. These concentration and

drug types may be changed periodically in response to factors such as

changes in detection technology and patterns of drug use. Finally, PT

samples may be constituted with interfering substances.

Section 3.19 Evaluation of Performance Testing

(a) Initial Certification. (1) An applicant laboratory shall not

report any false positive result during PT for initial certification.

Any false positive will automatically disqualify a laboratory from

further consideration.

(2) An applicant laboratory shall maintain an overall grade level

of 90 percent for the three cycles of PT required for initial

certification, i.e., it must correctly identify and confirm 90 percent

of the total drug challenges. Any laboratory which achieves a score on

any one cycle of the initial certification such that it can no longer

achieve a total grade of 90 percent over the three consecutive PT

cycles will be immediately disqualified from further consideration.

(3) An applicant laboratory shall obtain quantitative values for at

least 80 percent of the total drug challenges which are 20

percent or 2 standard deviations (whichever range is

larger) of the calculated reference group mean. Failure to achieve 80

percent will result in disqualification.

(4) An applicant laboratory shall not obtain any quantitative

values that differ by more than 50 percent from the calculated

reference group mean. Any quantitative values that differ by more than

50 percent will result in disqualification.

(5) For any individual drug, an applicant laboratory shall

successfully detect and quantitate in accordance with paragraphs

(a)(2), (a)(3), and (a)(4) of this section at least 50 percent of the

total drug challenges. Failure to successfully quantitate at least 50

percent of the challenges for any individual drug will result in

disqualification.

(b) Ongoing Testing of Certified Laboratories. (1) False Positives

and Procedures for Dealing with Them. No false drug identifications are

acceptable for any drugs for which a laboratory offers service. Under

some circumstances a false positive test may result in suspension or

revocation of certification. The most serious false positives are by

drug class, such as reporting THC in a blank specimen or reporting

cocaine in a specimen known to contain only opiates. Misidentifications

within a class (e.g., codeine for morphine) are also false positives

which are unacceptable in an appropriately controlled laboratory, but

they are clearly less serious errors than misidentification of a class.

The following procedures shall be followed when dealing with a false

positive:

(i) The agency detecting a false positive error shall immediately

notify the laboratory and the Secretary of any such error.

(ii) The laboratory shall provide the Secretary with a written

explanation of the reasons for the error within 5 working days. If

required by paragraph (b)(1)(v) below, this explanation shall include

the submission of all quality control data from the batch of specimens

that included the false positive specimen.

(iii) The Secretary shall review the laboratory's explanation

within 5 working days and decide what further action, if any, to take.

(iv) If the error is determined to be an administrative error

(clerical, sample mixup, etc.), the Secretary may direct the laboratory

to take corrective action to minimize the occurrence of the particular

error in the future and, if there is reason to believe the error could

have been systematic, may require the laboratory to review and

reanalyze previously run specimens.

(v) If the error is determined to be a technical or methodological

error, the laboratory shall submit to the Secretary all quality control

data from the batch of specimens which included the false positive

specimen. In addition, the laboratory shall retest all specimens

analyzed positive by the laboratory from the time of final resolution

of the error back to the time of the last satisfactory performance test

cycle. This retesting shall be documented by a statement signed by the

laboratory's responsible person. Depending on the type of error which

caused the false positive, this retesting may be limited to one analyte

or may include any drugs a laboratory certified under these Guidelines

must be prepared to assay. The laboratory shall immediately notify the

agency if any result on a specimen that has been retested must be

corrected because the criteria for a positive are not satisfied. The

Secretary may suspend or revoke the laboratory's certification for all

drugs or for only the drug or drug class in which the error occurred.

However, if the case is one of a less serious error for which effective

corrections have already been made, thus reasonably assuring that the

error will not occur again, the Secretary may decide to take no further

action.

(vi) During the time required to resolve the error, the laboratory

shall remain certified but shall have a designation indicating that a

false positive result is pending resolution. If the Secretary

determines that the laboratory's certification must be suspended or

revoked, the laboratory's official status will become ``Suspended'' or

``Revoked'' until the suspension or revocation is lifted or any

recertification process is complete.

(2) Requirement to Identify and Confirm 90 Percent of Total Drug

Challenges. In order to remain certified, laboratories must

successfully complete four cycles of PT per year. Failure of a

certified laboratory to maintain a grade of 90 percent over the span of

two consecutive PT cycles, i.e., to identify 90 percent of the total

drug challenges and to correctly confirm 90 percent of the total drug

challenges, may result in suspension or revocation of certification.

(3) Requirement to Quantitate 80 Percent of Total Drug Challenges

at 20 Percent or 2 Standard Deviations.

Quantitative values obtained by a certified laboratory for at least 80

percent of the total drug challenges must be 20 percent or

2 standard deviations (whichever range is larger) of the

appropriate reference or peer group mean as measured over two

consecutive PT cycles.

(4) Requirement to Quantitate Within 50 Percent of Calculated

Reference Group Mean. After achieving certification a laboratory is

permitted one quantitative result differing by more than 50% from the

target value within two consecutive cycles of PT. More than one error

of this type within two consecutive PT cycles may result in a

suspension or proposed revocation.

(5) Requirement to Successfully Detect and Quantitate 50 Percent of

the Total Drug Challenges for Any Individual Drug. For any individual

drug, a certified laboratory must successfully detect and quantitate in

accordance with paragraphs (b)(2),(b)(3), and (b)(4) of this section at

least 50 percent of the total drug challenges.

(6) Procedures When Requirements in Paragraphs (b)(2)--(b)(5) of

this Section Are Not Met. If a certified laboratory fails to maintain a

grade of 90 percent over the span of two consecutive PT cycles after

initial certification as required by paragraph (b)(2) of this section

or if it fails to successfully quantitate results as required by

paragraphs (b)(3),(b)(4), or (b)(5) of this section, the laboratory

shall be immediately informed that its performance fell under the 90

percent level or that it failed to quantitate test results successfully

and how it failed to quantitate successfully. The laboratory shall be

allowed 5 working days in which to provide any explanation for its

unsuccessful performance, including administrative error or

methodological error, and evidence that the source of the poor

performance has been corrected. The Secretary may revoke or suspend the

laboratory's certification or take no further action, depending on the

seriousness of the errors and whether there is evidence that the source

of the poor performance has been corrected and that current performance

meets the requirements for a certified laboratory under these

Guidelines. The Secretary may require that additional performance tests

be carried out to determine whether the source of the poor performance

has been removed. If the Secretary determines to suspend or revoke the

laboratory's certification, the laboratory's official status will

become ``Suspended'' or ``Revoked'' until the suspension or revocation

is lifted or until any recertification process is complete.

(c) 80 Percent of Participating Laboratories Must Detect Drug. A

laboratory's performance shall be evaluated for all samples for which

drugs were spiked at concentrations above the specified performance

test level unless the overall response from participating laboratories

indicates that less than 80 percent of them were able to detect a drug.

(d) Participation Required. Failure to participate in a PT cycle or

to participate satisfactorily may result in suspension or revocation of

certification.

Section 3.20 Inspections

(a) Frequency. Prior to laboratory certification under these

Guidelines and at least twice a year after certification, a team of

three qualified inspectors, at least two of whom have been trained as

laboratory inspectors, shall conduct an on-site inspection of

laboratory premises. Inspections shall document the overall quality of

the laboratory setting for the purposes of certification to conduct

urine drug testing. Inspection reports may also contain recommendations

to the laboratory to correct deficiencies noted during the inspection.

(b) Inspectors. The Secretary shall establish criteria for the

selection of inspectors to ensure high quality, unbiased, and thorough

inspections. The inspectors shall perform inspections consistent with

the guidance provided by the Secretary. Inspectors shall document the

overall quality of the laboratory's drug testing operation.

(c) Inspection Performance. The laboratory's operation shall be

consistent with good forensic laboratory practice and shall be in

compliance with these Guidelines. It is the laboratory's responsibility

to correct deficiencies identified during the inspection and to have

the knowledge, skill, and expertise to correct deficiencies consistent

with good forensic laboratory practice. Consistent with sections 3.13

and 3.14, deficiencies identified at inspections may be the basis for

suspending or revoking a laboratory's certification.

Section 3.21 Results of Inadequate Performance

Failure of a laboratory to comply with any aspect of these

Guidelines may lead to revocation or suspension of certification as

provided in sections 3.13 and 3.14 of these Guidelines.

Section 3.22 Listing of Certified Laboratories

A Federal Register listing of laboratories certified by HHS will be

updated and published periodically. Laboratories which are in the

applicant stage of HHS certification are not to be considered as

meeting the minimum requirements in these Guidelines. A laboratory is

not certified until HHS has sent the laboratory an HHS letter of

certification.

Subpart D--Procedures for Review of Suspension or Proposed Revocation

of a Certified Laboratory

Section 4.1 Applicability

These procedures apply when:

(a) The Secretary has notified a laboratory in writing that its

certification to perform urine drug testing under these Mandatory

Guidelines for Federal Workplace Drug Testing Programs has been

suspended or that the Secretary proposes to revoke such certification.

(b) The 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 4.2 Definitions

Appellant: Means the laboratory which has been notified of its

suspension or proposed revocation of its certification to perform urine

drug testing and has requested an informal review thereof.

Respondent: Means the person or persons designated by the Secretary

in implementing these Guidelines (currently the National Laboratory

Certification Program is located in the Division of Workplace Programs,

Substance Abuse and Mental Health Services Administration).

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 his or her

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 4.3 Limitation 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 Mandatory Guidelines for Federal Workplace Drug

Testing Programs, and other relevant law. The legal validity of the

Mandatory Guidelines shall not be subject to review under these

procedures.

Section 4.4 Specifying Who Represents the Parties

The appellant's request for review shall specify the name, address,

and phone number of the appellant's representative. In its first

written submission to the reviewing official, the respondent shall

specify the name, address, and phone number of the respondent's

representative.

Section 4.5 The Request for Informal Review and the Reviewing

Official's Response

(a) Within 30 days of the date of the notice of the suspension or

proposed revocation, the appellant must submit a written request to the

reviewing official seeking review, unless some other time period is

agreed to by the parties. A copy must also be sent to the respondent.

The request for review must include a copy of the notice of suspension

or proposed revocation, a brief statement of why the decision to

suspend or propose revocation is wrong, and the appellant's request for

an oral presentation, if desired.

(b) Within 5 days after receiving the request for review, the

reviewing official will send an acknowledgment and advise the appellant

of the next steps. The reviewing official will also send a copy of the

acknowledgment to the respondent.

Section 4.6 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 Mandatory Guidelines for Federal Workplace Drug Testing Programs 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 4.7 Preparation of 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

urine drug testing, tabbed and or

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