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Tuesday,

November 25, 2008

Part V

Department ofHealth and HumanServicesSubstance Abuse and Mental HealthServices Administration

Mandatory Guidelines for FederalWorkplace Drug Testing Programs; Notice

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71858 Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008/ Notices

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Substance Abuse and Mental HealthServices Administration

Mandatory Guidelines for FederalWorkplace Drug Testing Programs

AGENCY: Substance Abuse and MentalHealth Services Administration, HHS.ACTION: Revised Mandatory Guidelines.

SUMMARY: This Final Notice of Revisionsto the Mandatory Guidelines for FederalWorkplace Drug Testing Programs(Revisions to Mandatory Guidelines)addresses collection and testing of urinespecimens, the requirements for thecertification of Instrumented Initial TestFacilities (IITFs), and the role of andstandards for collectors and MedicalReview Officers (MROs). Additionalnotices of Proposed Revisions to theMandatory Guidelines addressing the

use of point of collection testing(POCT), oral fluid testing, sweat patchtesting, hair testing, and associatedissues will be published at a later date.With regard to the use of alternativespecimens including hair, oral fluid,and sweat patch specimens in FederalWorkplace Drug Testing Programs,significant issues have been raised byFederal agencies during the reviewprocess which require furtherexamination, and may requireadditional study and analysis. As part ofthe review process for these alternativetests, the Department of Health and

Human Services (HHS orDepartment) plans to issue a notice inthe Federal Register requestinginformation and assistance from thegeneral public to provide or identifydata and research findings that addressspecific areas of interest.DATES: Effective Date:March 25, 2008.FOR FURTHER INFORMATION CONTACT:Donna M. Bush, Ph.D., Division ofWorkplace Programs, CSAP, SAMHSA,1 Choke Cherry Road, Room 21033,Rockville, Maryland 20857, (240) 2762600 (phone), (240) 2762610 (Fax), ore-mail at [email protected] INFORMATION

:Background

The Guidelines were first publishedin the Federal Register on April 11,1988, (53 FR 11970), and have since

been revised in the Federal Register onJune 9, 1994, (59 FR 29908), onSeptember 30, 1997, (62 FR 51118), onNovember 13, 1998 (63 FR 63483), andon April 13, 2004, (69 FR 19644). TheGuidelines establish the scientific andtechnical guidelines for Federalworkplace drug testing programs and

establish standards for certification oflaboratories engaged in drug testing forFederal agencies under authority ofsection 503 of Public Law 10071, 5U.S.C. Section 7301 note, and ExecutiveOrder (E.O.) 12564.

The Department also publishedProposed Revisions to MandatoryGuidelines in the Federal Register on

April 13, 2004, (69 FR 19673). TheseProposed Revisions to MandatoryGuidelines described changing theGuidelines into a plain language format,expanding the Federal drug testingprogram to include use of alternativespecimens including testing hair, oralfluid, and sweat patch specimens,allowing the use of point of collectiontesting (POCTs) for urine and oral fluidspecimens, establishing therequirements for certifyinginstrumented initial test facilities(IITFs) to test specimens, and providingspecific standards for collectors, POCT

testers, and MROs. There was a 90-daypublic comment period during which285 commenters submitted commentson the proposed changes to theGuidelines. These commenters wereindividuals and public and privateentities. The comments are available forpublic view on the DepartmentsInternet Web site (http://workplace.samhsa.gov).

Section 503 of Public Law 10071, 5U.S.C. Section 7301 note, required theDepartment to establish scientific andtechnical guidelines and amendments inaccordance with Executive Order 12564,and to publish Mandatory Guidelines

which establish comprehensivestandards for all aspects of laboratorydrug testing and procedures, includingstandards that require the use of the bestavailable technology for ensuring thefull reliability and accuracy of drug testsand strict procedures governing thechain of custody of specimens collectedfor drug testing. These revisions to theMandatory Guidelines promote andestablish standards that use the bestavailable technology for ensuring thefull reliability and accuracy of urinedrug tests, while reflecting the ongoingprocess of review and evaluation of

legal, scientific, and societal concerns.The submitted public comments andadditional comments raised by FederalAgencies during subsequent internalreview of the proposed changes to theGuidelines raised significant scientific,legal, and public policy concerns aboutthe use of alternative specimens andPOCT devices in Federal agencyworkplace drug testing programs. Sinceeach alternative specimen and drugtesting using POCT devices posesdifferent concerns, the Departmentestablished a staggered timeline for

issuing final guidance that allows forfurther study and research. In assessingthe complexity of the task, theDepartment has decided to publishthese final Guidelines with regard tocollection and testing urine specimens,establishing the requirements for thecertification of IITFs, and establishingspecific standards for collectors and

MROs. The Department consideredseveral options for issuing one or moreFinal Notices in the Federal Registerthat may require additional publiccomment periods, concerning the use ofalternative specimens and drug testingtechnologies such as POCT devices.Since the scientific, legal, and publicpolicy information for drug testing oralfluid, hair, and sweat patch specimens,and using POCT devices is not ascomplete as it is for the laboratory-basedurine drug testing program, developingFinal Notices concerning the use ofthese is more challenging. As described

in the notice of Proposed Revisions toMandatory Guidelines issued April 13,2004, the performance of alternativespecimens in pilot performance testing(PT) programs has been encouraging,with individual laboratory and groupperformance improving over time.However, there are still three areas ofconcern. First, the data from the pilotPT programs to date show that not allparticipants have developed thecapability to test for all required drugclasses, nor to perform such tests withacceptable accuracy. Second, some drugclasses are more difficult to detect than

others, for any given type of specimen.Third, the specific drug classes that aredifficult to detect vary by type ofspecimen. As a result, it will requireadditional study to assist agencies indetermining how to select theappropriate type of specimen to becollected from a specific donor, whenthe use of a specific drug is suspected.Nevertheless, HHS believes that theaddition of alternative specimens to theFederal Workplace Drug TestingProgram would complement urine drugtesting and aid in combating the risksposed from available methods ofsuborning urine drug testing throughadulteration, substitution, and dilution.Thus, HHS will continue to pursuetesting using alternative specimens.HHS anticipates issuing furtherrevisions to the Mandatory Guidelinesaddressing the use of oral fluid, sweatpatch, and hair, and the use of POCTdevices for urine and oral fluid. Theserevisions will be published in theFederal Register, with opportunity forpublic comment.

All written comments were reviewedand taken into consideration in the


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71859Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008/ Notices

preparation of these revised Guidelines.The preamble only addresses sections ofthe draft Guidelines regarding urinetesting that were commented on duringthe public comment period or that theDepartment is changing. Most sectionnumbers for the Guidelines issued inApril 2004 were changed in theseGuidelines due to the removal of those

sections concerning alternativespecimens and POCT as well as forclarity. To make it easier for the public,the preamble refers to the new sectionnumber and, where appropriate, thecorresponding section number in theProposed Revisions to MandatoryGuidelines issued in April 2004. Similarcomments are considered together in thediscussion.

Reason for the Effective Date

An effective date of 18 months fromthe date of publication of these revisedMandatory Guidelines was chosen to

permit the following activities:(1) It will take at least 12 months formanufacturers of immunoassay test kitsto modify or manufacture immunoassaytest kits and ensure compliance withany applicable statutory and regulatoryrequirements before commercializationof the modified kits.

(2) It will take the HHS-certifiedlaboratories at least one month tovalidate and implement the new testkits.

(3) It will take 2 to 3 months for theNational Laboratory CertificationProgram (NLCP) to challenge the HHS-certified laboratories with performance

testing (PT) samples to ensure that thetest kits and test results satisfy therequired performance criteria.

The effective time frame of 18 monthswill encompass many activities that willoverlap or occur at the same time withindifferent industries and Federalagencies.

Summary of Public Comments and theHHS Response

The following comments weredirected to the information andquestions in the preamble.

Initial Test Kit Issues

In the proposed Guidelines, theDepartment requested comments onissues regarding the testing foramphetamine analogs using one or twoimmunoassay test kits because thelaboratory or IITF would be required totest specimens for the target analyteslisted under amphetamines. Twocommenters believed that two separateinitial test kits would be needed toappropriately screen specimens foramphetamines as specified in Section3.4. One commenter believed three

separate initial test kits may be required.Six commenters believed that one initialtest kit could be used to screen foramphetamine, methamphetamine, andtheir analogs. For the most part, thecommenters provided justifications fortheir comments. The Department hasevaluated the comments and hasconcluded that using either a single

initial test kit or multiple initial test kitsis acceptable depending on thespecificity and sensitivity that the singleinitial test kit has with amphetamineand methamphetamine and its cross-reactivity withmethylenedioxymethamphetamine(MDMA).

Subpart AApplicability

The Department has revised Section1.1 to state that the requirements inthese Guidelines also apply to collectorsand MROs. This revision ensures thatcollectors and MROs are notified of the

applicable requirements under theseGuidelines.In Section 1.5, where terms are

defined, the Department has addedseveral new definitions for terms thatappear in the Guidelines, and revisedseveral definitions that neededclarification even though no commentswere received from the public.

The Department has changed the termto be defined from adulterated toadulterated specimen. The meaningof the term has not changed. Only thewording has been changed to make thedefinition clearer.

Definitions were added for alternate

responsible person and alternateresponsible technician, the individualswho are pre-approved by HHS toassume responsibility for the HHS-certified drug testing laboratory or IITF,respectively, when the responsibleperson or responsible technician isabsent for an extended period.

The definition for cancelled testwas reworded for clarification. Thedefinition is the same.

The term carryover was defined.Carryover, as used in these Guidelines,refers to the condition that results whenthe test result for one sample has been

affected by a preceding sample duringanalysis. For example, if theconcentration of a drug in one sampleis very high and cannot be completelyeliminated from the analyticalinstrument before the next sample istested, the residual drug in theanalytical instrument contributes to theconcentration of that drug in the nextsample.

The definition for certifyingscientist was revised to indicate that acertifying scientist can report any testresult reported from an HHS-certified

laboratory. The proposed definitionreferred to non-negative or invalidresult. Since the term non-negativewas deleted from these Guidelines, thedefinition for certifying scientist neededto be revised.

The definition for certifyingtechnician was revised to state that acertifying technician can report on the

chain of custody and scientificreliability of negative, negative/dilute,and rejected for testing results. Thisrevised definition clarifies which typesof results a certifying technician canreport. The proposed definitionincorrectly permitted the certifyingtechnician to report on the chain ofcustody and scientific reliability of onlynegative test results.

The term confirmatory validity testwas changed to confirmatory specimenvalidity test. The term validity testwas changed to specimen validity testthroughout the Guidelines, to be

consistent with current terminologyused by the Department.The definition for a cutoff was

revised to apply to specimen validitytests, as well as drug tests. The term isused in both contexts.

The definition for dilute specimenwas revised to state that the termapplies to a urine specimen withcreatinine and specific gravity valuesthat are lower than expected but stillphysiologically possible. This changeshows that a dilute specimen is differentfrom a substituted specimen.

The definition for failed toreconfirm was revised to clarify that

the term applies when a secondlaboratory tests a split (Bottle B)specimen and is unable to corroboratethe original test result reported by theprimary laboratory.

The definition for follow-up testwas removed. The definition forfollow-up test is provided in Federalagency drug testing plans and does notneed to be repeated in the Guidelines.

The definition for an initial validitytest was changed to initial specimenvalidity test throughout the Guidelinesto be consistent with currentterminology used by the Department.

The term was also revised to include aninvalid result because an invalidresult requires using an initialspecimen validity test as would anadulterated, diluted, or substituted testresult.

To avoid confusion, the definitionsfor an instrumented initial test facilityand for a laboratory were revised toshow that these are permanentlocations.

The definition for invalid resultwas revised to clarify that this type ofresult is reported when the test results


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satisfy the criteria established in Section3.8. The definition in the draft issuancedid not include all of the criteriadescribed in Section 3.8.

A definition for limit of detection(LOD) has been added to theseGuidelines because the Guidelinesrequire the laboratory to determine theLOD for each confirmatory drug test

during assay validation. In addition, tovalidate specimen validity tests,laboratories and IITFs are required todemonstrate and document appropriateassay characteristics, which mayinclude the LOD.

A definition for limit ofquantitation (LOQ) has been added tothese Guidelines because the Guidelinesrequire the laboratory to determine theLOQ for each confirmatory drug testduring assay validation. In addition, tovalidate tests used to determinespecimen validity, laboratories andIITFs are required to demonstrate anddocument appropriate assaycharacteristics, which may include theLOQ. Lastly, laboratories and IITFs arerequired to use the established LOQ asthe decision point for adulterantswithout a program-specified cutoff.

A definition for a lot has beenadded to these Guidelines becausethroughout the Guidelines there arerequirements to validate or verify theperformance characteristics of variousitems (e.g., drug test kits, reagents,quality control material) and to establishan expiration date. The term lot refersto the item(s) manufactured from thesame starting materials within a

specified period of time which haveessentially the same performancecharacteristics and the same expirationdate.

The definition for a negative resultwas revised to clarify that the specimenmust not only be negative for drugs butmust also be a valid urine specimen.Since these Guidelines require thatspecimen validity tests be conducted oneach specimen, this definition statesthat a negative result indicates that aspecimen is not only negative for drugs

but also that the specimen validity testsconducted on the specimen indicate

that the specimen is a valid specimen.The definition for a non-negativeresult was removed from the list ofdefinitions and replaced with morespecific reporting terms as follows:Positive result, substituted specimen,adulterated specimen, or invalidspecimen result.

The definition for a performancetesting (PT) sample was revised toshow that it refers to samples that areprogram-generated and sent to a testingfacility. The proposed definition did notindicate the source of the samples.

The definition for a post-accidenttest was removed. The definition forpost-accident test is provided inFederal agency drug testing plans anddoes not need to be repeated in theGuidelines.

The definition for a pre-employmenttest was removed. The definition forpre-employment test is provided in

Federal agency drug testing plans anddoes not need to be repeated in theGuidelines.

The definition for a quality control(QC) sample was revised to clarify thatthe term refers to calibrators or controls.

The definition for a random testwas removed. The definition forrandom test is provided in Federalagency drug testing plans and does notneed to be repeated in the Guidelines.

The definition for a reasonablesuspicion/cause test was removed. Thedefinition for reasonable suspicion/cause test is provided in Federal

agency drug testing plans and does notneed to be repeated in the Guidelines.

The definition for reconfirmed wasrevised to clarify that the definitionapplies to a split specimen (Bottle B)tested by a second laboratory.

The definition for return to dutytest was removed. The definition forreturn to duty test is provided inFederal agency drug testing plans anddoes not need to be repeated in theGuidelines.

The definition for rejected fortesting was revised to clarify that thisresult may be reported by an IITF, as

well as a laboratory.Three commenters noted the termssample and specimen were usedinterchangeably throughout theGuidelines and suggested that thedefinitions be defined and the textupdated accordingly. The Departmentagrees and has revised the definitionsfor these terms and has revised theGuidelines text to consistently use theterms as they are defined in this section.Sample refers to a performancetesting (PT) sample, a quality controlsample, or a representative portion of adonor specimen. Specimen refers tothe donor specimen (i.e., urine provided

by the donor for the drug test).The term split specimen was

replaced by split specimen collection.The definition of a split specimencollection states that one urinespecimen of sufficient volume iscollected and then divided into twoseparate specimen bottles. A splitspecimen collection does not permitcollecting two different urine specimensat two different times that are,respectively, transferred to a Bottle Aand a Bottle B.

The definition for substituted waschanged to substituted specimen andrevised to define this as a specimensubmitted in place of the donors urine,as evidenced by creatinine and specificgravity values outside physiologicallyproducible ranges of human urine.

Section 1.6 describes what an agencyis required to do to protect employeerecords. The policy in this section is thesame as the policy in the ProposedRevisions to Mandatory Guidelines. TheDepartment has included a discussionon the Health Insurance Portability andAccountability Act of 1996 (HIPAA).

The Department has included a newSection 1.7, to clarify refusals to test andwho ultimately determines if theconditions for verifying them are met(i.e., the collector, the MRO, the Federalagency).

Subpart BSpecimens

Section 2.1 states that urine is theonly specimen that can be collected bya Federal agency under the Guidelinesfor its workplace drug testing programto clarify that Federal agencies areprohibited from collecting any othertype of specimen.

Section 2.2 describes thecircumstances under which a Federalagency may collect a specimen. TheDepartment has included this section toensure that the circumstances describedare consistent with the reasons forcollecting a specimen as listed on theFederal CCF.

Section 2.3 requires each urinespecimen to be collected as a splitspecimen. This policy is the same as thepolicy described in the ProposedRevisions to Mandatory Guidelines.Five commenters opposed the part thatthe single urine specimen collectionprocedure was being eliminated. TheDepartment disagrees with thecommenters and has eliminated thesingle urine specimen collectionprocedure, not because the procedure isforensically or scientificallyunsupportable, but because the splitspecimen procedure ensures that the

donor will have access to a splitspecimen that was not opened by thelaboratory testing the primary specimen.Additionally, there are a number ofFederal employees working for agenciesthat have employees subject to bothFederal drug testing guidelines andDepartment of Transportationworkplace drug testing regulations.Requiring the use of a split specimencollection procedure will ensure thatemployees working in these dualregulation situations are treated thesame.


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Subpart CDrug and SpecimenValidity Tests

Section 3.1 describes the tests that areperformed on each urine specimen. Thepolicy in this section applies to eachspecimen collected by a Federal agencyregardless of the circumstance for whichit was collected as described in Section2.2. The Department believes that thewording of the policy in the current andProposed Revisions to MandatoryGuidelines may be incorrectlyinterpreted such that the required testsonly apply to specimens collected fromFederal agency applicants andspecimens collected at random.However, this is not the case. Thewording in this section has been revisedto state that each specimen collectedwill be tested for the same drugs andspecimen validity tests. This sectionwas also revised to describe thespecimen validity tests that must beperformed on each urine specimen. The

requirements and explanationsdescribed for the specimen validity testsare the same as those described in thecurrent and Proposed Revisions toMandatory Guidelines.

Section 3.2 provides guidance on howa Federal agency may test a specimenfor additional drugs. Three commentersrequested additional guidance on how aFederal agency would requestpermission to test for an additional drugon a case-by-case basis. The Department

believes the policy in Section 3.2(a)adequately describes how a Federalagency would request to test a donors

specimen for a suspected Schedule I orSchedule II drug that is not part of theFederal program.

After further review of Section 3.2(a),however, the Department recognizedthat the Guidelines do not address howto proceed if the Federal agency isrequesting to test for a Schedule I or IIdrug for which an immunoassay test isnot available. The Department thus hasadded that when the need to test for anadditional drug occurs and there is noimmunoassay test available, an HHS-certified laboratory should be permittedto test for the drug by testing two

separate aliquots of the specimen usingthe same confirmatory drug test. Theconfirmatory drug test used by thelaboratory must satisfy the requirementsin Section 11.13, the laboratory mustvalidate the confirmatory drug test inaccordance with the requirements inSection 11.14, and must satisfy thequality control requirements as stated inSection 11.15. The Department believesthat testing the specimen twice using avalidated confirmatory drug test isscientifically and forensicallyacceptable. Additionally, when a

specimen is reported as positive,adulterated, or substituted, theDepartment allows the donor to requestthat Bottle B be tested at another HHS-certified laboratory by the confirmatorymethod. The testing of the splitspecimen by a second HHS-certifiedlaboratory to reconfirm the drugreported positive by the first laboratory

is sufficient to protect the donorsinterests.

Section 3.3 states that urinespecimens collected for Federal agencyworkplace drug testing programs mayonly be tested for the purpose ofdetecting drug use and to determine thevalidity of the specimen unlessotherwise authorized by law. Severalcommenters expressed concern over thepossibility that DNA testing could beconducted on a specimen. TheDepartment states in Section 3.3(a) thatFederal agency specimens * * * mustonly be tested for drugs and to

determine their validity unlessotherwise authorized by law. TheDepartment is satisfied that the policy,as stated, prohibits DNA testing on aspecimen but has removed the phraseunless otherwise authorized by lawfrom this section to clarify that Federalagency specimens must only be testedfor drugs and to determine theirvalidity.

Section 3.4 lists the drugs and drugmetabolites and the initial andconfirmatory cutoff concentrations usedto test and report urine specimens asnegative or positive for a drug. Theinitial and confirmatory cutoff

concentrations are the same as in theProposed Revisions to MandatoryGuidelines, but the tables have beencombined to make it easier for thereaders.

Several commenters suggestedincluding the scientific rationale used tosupport the proposed changes to thecocaine metabolite (benzoylecgonine)and amphetamine cutoff concentrations.Three commenters disagreed with theproposal to lower the amphetaminesinitial test cutoff concentration. Two ofthe three commenters were concernedthat the lower cutoff will result in

higher costs and more false initial testpositives due to medications availableover the counter. The third commenterstated that their laboratory currently hascustomers who use the loweramphetamine cutoff concentration andhave no more confirmed positives thancompared to a 1000 ng/mL initial testcutoff, but who do have moreunconfirmed specimens.

The Department believes the revisedcutoff concentrations will increase thewindow of detection for these drugs,i.e., the number of hours after a drug is

ingested by an individual that theconcentration of the drug or drugmetabolite in urine will likely remainabove the cutoff concentration. Lowercutoff concentrations will increase thenumber of urine specimens that areidentified as containing cocainemetabolites and amphetamines and,thereby, will increase the deterrent

effect of the program and improveidentification of employees using illicitsubstances. Based on results reported bylaboratories in the current urine PTprogram, the Department believes thatcertified laboratories (and IITFs afterthey are certified) will have the abilityto report accurate test results usingthese revised cutoff concentrations.There is no evidence available to theDepartment to indicate that loweringthese cutoff concentrations will increasethe possibility that a donor who has notactually used cocaine or amphetamineswill be identified as a drug user. The

Department also points out that theindividual can always challenge theresult with the MRO.

Several commenters raised questionsregarding the proposed options for HHS-certified laboratories and IITFs toperform an initial test for 6AM. Thecommenters stated that the policyoptions were unclear as presented inSection 3.4, and recommended thatHHS provide additional guidance toprevent inconsistent treatment ofspecimens. The Department has revisedthe table and footnotes in Section 3.4 toclarify that all specimens tested foropiates must be tested for 6AM. This

policy allows a laboratory to confirmand report 6AM by itself, in contrast tothe current Guidelines policy whichrequires 6AM to be tested and reportedin conjunction with a positive morphineresult. Data from laboratories indicatethat 6AM is present in specimens evenwhen the morphine concentration is

below 2000 ng/mL.Sections 3.5, 3.6, 3.7, and 3.8 describe

the criteria for reporting a urinespecimen as adulterated, substituted,dilute, and invalid, respectively. Eachsection was revised to clarify that onlya certified laboratory may report a

specimen as adulterated, substituted, orinvalid; that only a certified laboratorymay report a specimen as dilute whencreatinine is equal to or less than 5 mg/dL; and that a laboratory or an IITF mayreport a specimen as dilute whencreatinine is greater than 5 mg/dL. Foran adulterated or invalid urinespecimen, one commenter requested therationale for changing from the 20 mcg/mL chromium (VI) [Cr (VI)] initialvalidity test cutoff in a previous draft(several preliminary versions of theGuidelines were posted on the


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SAMHSA workplace Web site before theProposed Revisions to MandatoryGuidelines were published in theFederal Register to 50 mcg/mL in theseGuidelines. One commenterrecommended using the 20 mcg/mL Cr(VI) cutoff instead of 50 mcg/mL andprovided supporting data. Although theDepartment agrees with the data

provided, the 50 mcg/mL cutoff isconsistent with the capabilities ofcurrent assays sensitivity andspecificity. Additionally, most, but notall, oxidants are quantified atconcentrations greater than 50 mcg/mLwhen they are used as urine adulterants.Unpublished evaluations of samplesspiked with Cr (VI) have shown that forCr (VI) to be effective as an adulterant,the urine concentration is usually muchgreater than 100 mcg/mL. For thesereasons, the Department believes thatthe 50 mcg/mL Cr (VI) cutoff issufficient to identify adulteration with

Cr (VI) and is appropriate. Onecommenter recommended using thelimit of quantitation (LOQ) instead ofthe limit of detection (LOD) as thedecision point for adulterant testswithout a program specified cutoff. Thecommenter stated that an LOQ ensuresthat the adulterant has been bothappropriately identified and quantified.The Department agrees and has revisedthe testing requirements in Sections 3.5and 3.8 to require that the adulterantsconcentration be equal to or greater thanthe LOQ that was determined by theHHS-certified laboratory.

The Department has revised Section

3.7 to clarify that a dilute result mayonly be reported in conjunction witheither a positive test result or a negativetest result. When a urine specimen isdetermined to be adulterated or whenan invalid result is being reported, theDepartment does not consider finding adilute result for such a specimen as

being correct. It is assumed that anadulterated or invalid urine specimenhas been tampered with and, if it alsohappens to satisfy the dilute criteria, thedilute result would actually bemeaningless. Additionally, bydefinition, when a urine specimen is

reported as substituted it cannot be adilute specimen. Therefore, a diluteresult cannot be reported in conjunctionwith a substituted result.

Subpart DCollectors

Section 4.1 describes who may collecta specimen for a Federal agency. Threecommenters recommended allowingdirect supervisors to routinely collectspecimens for federal agency applicanttests. The Department disagrees and hasalways prohibited an immediatesupervisor or hiring official from

routinely acting as a collector, unless noother collector is available and onlywhen the supervisor or hiring official isa trained collector.

Section 4.2 describes who may notcollect a specimen. Seven commenterswere opposed to the policy whichprohibits testing facility employees fromcollecting specimens if they could link

the donors identity to the test results.The Department has always prohibitedtesting facility (HHS-certifiedlaboratory) employees from collectingspecimens if they could link the donorsidentity to the test results and believesthat this policy is appropriate. TheDepartment revised this section toprohibit an employee who is in a testingdesignated position and subject to theFederal agency drug testing rules fromserving as a collector for co-workerswho are in the same testing pool or whowork together with that employee on adaily basis, and to prohibit an

individual from collecting his or herown urine for a federally regulated drugtest.

Section 4.3 describes therequirements for an individual to be acollector for a Federal agency. Sevencommenters disagreed with requiringcollectors to read and understand theGuidelines and felt this should belimited to the sections pertaining to thecollection of specimens. TheDepartment agrees and has revised thepolicy in Section 4.3(a) to reflect that acollector must be knowledgeable of thecollection procedure described in theGuidelines. Four commenters suggested

that there should be standardizedcollector training requirements anddocumentation requirements for allcollectors. The Department has revisedSection 4.3 to provide more details onthe requirements for collector trainingand the documentation requirements.The Department believes therequirements as described in thissection are sufficient and appropriate toensure that the collector can properlycollect a specimen and correctlycomplete the Federal Drug TestingCustody and Control Form (FederalCCF).

Several commenters believe it is notsufficient to allow the agency to selectthe observer if there is no collector ofthe same gender available, as stated inthe Proposed Revisions to MandatoryGuidelines. To address this concern, theDepartment has included a new Section4.4 that specifies training requirementsfor an individual to serve as an observerfor a direct observed collection (asdescribed in Section 8.9). The trainingrequirements are designed to ensure thatany individual serving as an observerhas been trained in procedures for a

direct observed collection, although heor she may not be a trained collector.Other training elements are included toensure that the observer interacts withthe donor in a professional manner,respecting the donors modesty andprivacy, and that he or she maintainsthe confidentiality of collectioninformation. The Department also

revised this section to allow thecollector or collection site supervisor toselect the observer.

Section 4.5 describes therequirements for an individual to be atrainer for collectors. Three commentersnoted that the Guidelines did notaddress approval and monitoring of thetrain the trainer courses. Currentlythere are organizations (e.g.,manufacturers, private entities,contractors, Federal agencies) that offertrain the trainer courses. TheDepartment does not believe that it isnecessary or appropriate to approve the

content of the train the trainercourses. If a trainer does not properlytrain individuals to be collectors,collector errors will result as theGuidelines are enforced and willdemonstrate the need to retrain thosetrainers.

Section 4.6 describes what a Federalagency must do before an individual ispermitted to collect specimens. Fivecommenters disagreed with therequirement for an organization thatmanages/employs collectors to retainthe collector training documents, sayingthis would be burdensome. Thecommenters recommend that collectors

be responsible for their owndocumentation. The Department agreesthat many collectors currently retaintheir training records and has revisedthe policy to indicate that a collector(who may be self-employed) ororganization (e.g., collector trainingcompany, third party administrator,Federal agency that employs its owncollectors) must maintain a copy of therecord that documents his or hertraining. The Department has alsorevised the question to require theFederal agency to ensure that therequirements of this section are satisfied

before a collector is permitted to collectspecimens rather than placing theburden on an organization to satisfy therequirements. The Federal agency isalways responsible for ensuring that acollector is properly trained.

Subpart ECollection Sites

Section 5.1 describes a collection siteas a permanent or temporary facility.The requirement for a collection site tohave provisions for donor privacyduring the collection procedure has

been moved from Section 5.1 to Section


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5.2, which describes the specificrequirements for a facility that is beingused as a collection site.

Two commenters recommendedincluding additional criteria in Section5.2 for a collection site to have a secureworking area and donor privacy. TheDepartment agrees and is requiring thecollection site in Section 5.2(a) to have

provisions to ensure donor privacy.Privacy requirements are set forth inSection 8.1. In addition, Section 5.2(b)has been revised to reflect the need fora suitable clean working area that is notaccessible to the donor. The Department

believes the clean working area mustnot be accessible to the donor because,if given an opportunity, a donor mayattempt to tamper with records,documents, or supplies. TheDepartment also added Section 5.2(g) torequire facilities to have the ability tolimit donor access to potentialcontaminants, adulterants, or diluents.

Section 5.3 describes how longrecords must be stored by collectionsites. The record storage requirements inthis section are the same as thosedescribed in the Proposed Revisions toMandatory Guidelines. The Departmentrevised the section to specify therecords that must be retained.

Subpart FFederal Drug TestingCustody and Control Forms

Section 6.1 states that an OMB-approved Federal CCF must be used todocument the collection of a urinespecimen. The requirement in thissection is the same as the requirement

described in the Proposed Revisions toMandatory Guidelines.Section 6.2 describes what happens if

the correct Federal CCF is not availableor is not used. The Departmentrecognizes that occasionally a currentFederal CCF will not be available or anon-Federal form or expired FederalCCF will be used by mistake. TheDepartment does not want thisdiscrepancy to cause a laboratory orIITF to automatically reject thespecimen for testing, or cause an MROto automatically cancel the test. If thecollector discovers the error before the

specimen is packaged for shipment to alaboratory or IITF, the collector mustnote on the form that the specimen is aFederal agency specimen and give thereason for using the incorrect form.When this information is provided onthe form, the laboratory or IITF simplyproceeds with testing the specimen as aFederal agency specimen. If thelaboratory, IITF, or MRO discovers thatan incorrect form was used and there isno explanation given, the laboratory,IITF, or MRO must attempt to obtain aMemorandum For Record (MFR) from

the collector explaining why anincorrect form was used. If a MFRcannot be obtained from the collector,the laboratory or IITF must report arejected for testing result (i.e., whenthey discovered the error) and the MROreports a cancelled test result.

Subpart GSpecimen Collection

ContainersSection 7.1 describes the items to be

used to collect a urine specimen. TheDepartment added volume requirementsfor specimen containers to this sectionto ensure that the containers usedwould be of a sufficient size to hold therequired amount of urine for primaryand split specimens.

Section 7.2 describes the requirementthat the collection items used must notaffect the specimen collected. Therequirement in this section is the sameas the requirement described in theProposed Revisions to MandatoryGuidelines. However, the proposedstatements regarding FDA clearance forthese collection items has beenremoved. FDA has regulatory oversightof a collection item as a device withinthe meaning of Section 201(h) of theFederal Food, Drug, and Cosmetic Act(the FFDCA) (21 U.S.C. 321(h)), and amanufacturer must comply with allstatutory and regulatory requirementsfor these devices.

Subpart HSpecimen CollectionProcedure

Section 8 establishes the proceduresfor collection of a urine specimen. The

Department revised and reorganized theurine collection procedures in theProposed Revisions to MandatoryGuidelines for clarity and to addressissues raised as described below.

Section 8.1 states the privacyrequirements for specimen collections.The procedure used to collect a urinespecimen must ensure that a donor isgiven a sufficient amount of privacyunder normal circumstances. That is, adonor is allowed to provide a urinespecimen in the privacy of a restroom oran enclosed stall. Four commentersraised concerns with the privacy

requirements that should be given adonor. The Department evaluated thesecomments and believes that it is moreappropriate to address the privacyrequirements in subpart H (whichaddresses the collection procedure)rather than discussing the privacyrequirements in subpart E (whichspecifies the requirements for acollection site). Section 8.1(a) addressesthe comments submitted by stating whomay be present during a collectionprocedure. Section 8.1(b) states that thecollector may be a different gender than

the donor, but the observer of a directobserved collection procedure must bethe same gender, and a monitor for amonitored collection must be the samegender unless the monitor is a medicalprofessional. Section 8.1(c) clarifies thatthe privacy given to a donor is visualprivacy because there may be situationswhere it is not possible to prevent the

collector from hearing sounds in theenclosure where the donor is providingthe specimen.

Section 8.2 describes what a collectormust do before starting a specimencollection procedure. One commenternoted that the proposed requirement tohave no other source of water (e.g., noshower or sink) in the enclosure whereurination occurs may not addresstemporary collection sites. Thecommenter recommended that theprocedure be revised to state that thecollector must disable or secure othersources of water in the restroom before

starting the collection procedure. Onecommenter noted that many publicrestrooms are equipped with toilets thathave sensors for automatic flushing. TheDepartment agrees and has revised thissection to read There must be no othersource of water (e.g., no shower or sink)in the enclosure where urination occursthat is not secured during thecollection. If the enclosure used by thedonor to provide a specimen has a sinkor other source of water besides thetoilet that cannot be disabled or secured,the collector must perform a monitoredcollection in accordance with Section8.11. The monitor will listen for any

sounds that may suggest possibleattempts by the donor to tamper withthe specimen.

Section 8.3 describes the preliminarysteps in the collection process. Fourcommenters recommended that theGuidelines describe the type ofidentification the collector provides tothe donor. The Department has revisedSection 8.3(c) and included someexamples of the type of identificationthat may be provided (e.g., driverslicense, employee badge issued by theemployer, any other pictureidentification issued by a Federal, State,

or local government agency). Twocommenters suggested that the collectormust point out to the donor, but notrequire the donor to read, the collectionprocedure instructions on the back ofthe Federal CCF. The Department agreeswith the comment and has revisedSection 8.3(f) to direct the collector onlyto inform the donor where the donorcan find the instructions for thecollection on the back of the FederalCCF. The collector will allow the donorto read the procedure if the donorprefers. One commenter suggested that


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the donor be given the collectors fullname, name of the collectorssupervisor, name of the companyconducting the test, and the MROsname, telephone, and address. TheDepartment agrees with this comment.With the exception of the name of thecollectors supervisor, the rest of thecommenters request for information is

recorded on the donors copy of theFederal CCF. If some of the informationis missing on the Federal CCF, it is theresponsibility of the collector to obtainthe information and to complete theFederal CCF in accordance with theinstructions for the use of the FederalCCF for Federal agency workplace drugtesting programs.

Section 8.4 describes the steps thatthe collector takes in the collectionprocess before the donor provides aurine specimen. The steps are the sameas in the Proposed Revisions toMandatory Guidelines, but include

additional detail.Section 8.5 specifically addresses thesituation where a donor states that he orshe is unable to provide a urinespecimen. Over 50 commentersexpressed concern with theDepartments urine collection policy.They stated that some individuals havewhat the commenters refer to as a shy

bladder. The commenters noted thatthese individuals may be physicallyunable to provide a urine specimenupon demand, and forcing them todrink fluids creates a great deal of stressand may not change their ability toprovide a specimen. The commenters

were concerned with how a collectorinteracts with a donor who is unable toprovide a sufficient amount of urine toperform a drug test. The Departmentsurine collection policy was designed toprevent an individual from intentionallycircumventing the requirement toprovide a urine specimen during arequired collection. The policy is notintended to cause harm to anyone whohas a condition that prevents them fromproviding a urine specimen whenrequested. The Department has alwaysexpected a collector to treat the donorwith respect when the donor is unable

to provide a specimen within areasonable period of time (3 hours isconsidered reasonable). To address theconcern, however, the Department hasrevised the urine specimen collectionprocedure. If the donor states that he orshe cannot provide a specimen, thecollector requests the donor to go intothe restroom (stall) and attempt toprovide a specimen. This attemptdemonstrates the donors inability toprovide a specimen when the donorcomes out of the stall with an emptycollection container. At that time, if the

donor states that he or she couldprovide a specimen after drinking somefluids, the collector allows the donor todrink some liquid (as stated in Section8.5(b)(1)) and continues with thecollection procedure. If the donor statesthat he or she simply needs more time,without a need to drink fluids, beforeattempting to provide a urine specimen,

the collector gives the donor up to 3hours to provide a urine specimen. Ifthe donor states that he or she is unableto provide a urine specimen even after3 hours, the collector records the reasonfor not collecting a urine specimen onthe Federal CCF, notifies the Federalagencys designated representative, andsends the Federal CCF to the MRO andthe Federal agency for furtherevaluation of the donor. Therequirement for the further evaluation ofthe donor by an MRO will preventindividuals from being falsely accusedof a refusal to test.

Sections 8.5(b)(1) and 8.6(e)(2)describe the amount of fluid that adonor may be given at the collection sitein order to collect a sufficient amount ofurine. The reason why a limit isimposed at all is the concern for thewelfare of the donor, as well as theconcern that the urine specimen may

become diluted. Several commentersexpressed concern with the amount offluids given to a donor at the collectionsite. The Proposed Revisions toMandatory Guidelines instruction to thecollector to give the donor a reasonableamount of liquid to drink is flexible in

the amount given (note that theparenthetical in the Guidelines is statedas an example, not as a requirement).However, in response to the comment,the Department has changed theexample in the Proposed Revisions toMandatory Guidelines (an 8 ounceglass of water every 30 minutes, but notto exceed a maximum of 24 ounces) toread an 8 ounce glass of water every 30minutes, but not to exceed a maximumof 40 ounces over a period of 3 hoursor until the donor has provided asufficient urine specimen. This changeretains the flexibility that has always

existed in the Federal program and setsa reasonable time limit within whichmost donors would be able to providean acceptable amount of urine.Although the Department has changedthe guidance on the amount of fluidgiven the donor, the Department doesnot require anyone to drink more fluidthan he or she could comfortably drink.A statement has also been added tothese sections to clearly state that thedonor is not required to drink any fluidsduring this waiting time. TheDepartment believes that most

individuals who are unable to providea sufficient specimen simply need someadditional time to provide the requiredspecimen without having a need todrink fluids.

Section 8.6 describes the steps thatthe collector takes in the collectionprocess after the donor provides a urinespecimen. One commenter

recommended that the collector beinstructed to inspect the stall for signsof tampering before the donor ispermitted to flush the toilet. While thispractice is acceptable, the Departmenthas not included this detail in theGuidelines. Sections 8.2 and 8.3 includepre-collection procedures to prevent ordetect specimen tampering.Furthermore, Section 8.4(b) instructs thecollector to perform a recollection underdirect observation if the donors conductindicates a possible attempt toadulterate or substitute the specimen.

Section 8.6 also includes proceduresfor the collector to measure thespecimen temperature, visually inspectthe specimen, and determine thespecimen volume. Three commentersrecommended deleting the proposedrequirements for a collector to send aBottle A specimen to the testing facilitywhen there is an insufficient volume ofurine collected for the split (Bottle B)specimen as required because thiscontradicted the proposed policy that afailure to provide 30 mL of urine for thesecond specimen collection prompts thecollector to obtain guidance on theaction to be taken. The Departmentagrees and has revised the collection

procedures to stop the collection whenthe donor does not provide at least 45mL, the amount required for a splitspecimen collection, after two attempts.When this occurs, the collector notifiesthe Federal agencys designatedrepresentative immediately, and noteson the Federal CCF the donors failureto provide sufficient urine. The FederalCCF is sent to the Federal agency andthe MRO. Subsequent actions by theMRO are described in Sections 13.5 and13.6.

Section 8.8 is a new section thatcombines the reasons that appear in

different sections of the currentGuidelines regarding when a directobserved collection is used. The reasonsare the same; they have simply beencombined in one section. Section 8.8(c)requires the collector to notify acollection site supervisor to review andconcur with the collectors decision toperform a direct observed collectionprocedure. Three commenters disagreedwith this policy. One commenterrecommended requiring an agencyrepresentative in addition to thesupervisor to review and concur with


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the decision. The Department believesobtaining permission from a supervisoris necessary when a decision is neededto conduct a direct observed collection.The concurrence from a supervisor willensure that the collector is justified inusing a direct observed collectionprocedure. The Department alsoincluded in this section the actions a

collector must take when the donorrefuses to provide a specimen underdirect observation.

Section 8.9 is a new section thatdescribes how a direct observedcollection procedure is conducted. TheProposed Revisions to MandatoryGuidelines discussed when a directobserved collection procedure ispermitted, but did not provide guidanceon how it is to be conducted. TheDepartment has included additionalinformation regarding direct observedcollections. This information has beenavailable from the Department and has

been used since the beginning of theFederal drug testing program. TheDepartment believes that the procedurewill ensure that all direct observedcollection procedures are conducted thesame way regardless of the reason forusing the direct observed procedure. Inresponse to submitted comments, inaddition to requiring the observer to bethe same gender as the donor, theDepartment has specified in Section 8.9that individuals must be trained indirect observed collection procedures inorder to serve as an observer. Trainingrequirements are included in a newSection 4.4. The Department included

two new sections, Sections 8.9 and 8.10,to address when and how monitoredcollections are performed.

Section 8.12 establishes how thecollector reports a donors refusal totest. The Proposed Revisions toMandatory Guidelines discussed whatconstituted a refusal to test during thecollection process, but did not provideguidance to the collector on how toreport a refusal to test. Additionalinformation regarding urine collection isavailable from the Department. Inaddition, the Department included aninstruction for the collector to discard

any urine collected when a refusal totest occurred during the collectionprocess.

Section 8.13 establishes theresponsibilities for Federal agenciesregarding collection sites. Manycommenters disagreed with requiringFederal agencies to inspect all of theircollection sites. The commenters believethis requirement to inspect thehundreds of collection sites would becost-prohibitive and logisticallyimpossible, and there does not seem to

be evidence that errors by collectors are

common enough to justify such aninspection program. Other commenterssuggested that, in lieu of annualinspections of all collection sites, HHSrequire agencies to inspect onlycollection sites which have generatedfatal flaws. The Department agreesthat requiring Federal agencies toinvestigate and possibly inspect

collection sites with rejected fortesting errors ensures that collectorswill receive appropriate training toprevent the recurrence of such errors.However, the Department maintains thatrandom inspections are important toidentify any collection procedureproblems that may exist, but are notreadily evident from the Federal CCF

because the forms appear to be properlycompleted by the collector. TheDepartment has revised the inspectionrequirements in this sectionaccordingly. Federal agencies mustinspect only 5 percent of the current

number of collection sites, or up to amaximum of 50, selected randomly, oftheir collection sites each year.Additionally, Federal agencies arerequired to investigate reportedcollection site deficiencies (e.g.,rejected for testing by either an HHS-certified laboratory or HHS-certifiedIITF) and take appropriate action whichmay include inspecting the collectionsite. The number of collection sitesinspected because they have hadrejected for testing results are notincluded in the 5 percent or maximumof 50 requirement.

Subpart IHHS Certification ofLaboratories and IITFs

The proposed section describing thegoals and objectives of certifyinglaboratories and IITFs was removedfrom the Guidelines. Four commenterssuggested that the discussion should bein the preamble rather than in theGuidelines. The Department agrees thatthe discussion in this section does notestablish any specific analyticalrequirements and was removed fromthese Guidelines.

Section 9.1 (Section 9.2 in theProposed Revisions to Mandatory

Guidelines) states that the Secretary hasthe authority to certify laboratories.Four commenters disagreed with theright of the Secretary to review privatesector specimen results tested under theGuidelines. The Departmentunderstands the concerns expressed bythe commenters; however, the review ofprivate sector specimen or non-regulated specimen results, only occursfor those private sector specimens thatare tested in batches that containfederally-regulated specimens. Thisusually occurs with confirmatory test

batches because laboratories assemblethese batches by taking the initial testpositive specimens from different initialtest batches to make the confirmatorytest cost effective and efficient.Therefore, the policy described in thissection is the same policy as describedin the Proposed Revisions to MandatoryGuidelines.

Section 9.2 (Section 9.3 of theProposed Revisions to MandatoryGuidelines) describes the applicationprocess for a laboratory or IITF,procedures for maintaining certification,and what a laboratory or IITF must dowhen its certification is not maintained.In the Proposed Revisions to MandatoryGuidelines, the term imminent harmis used as a reason to require alaboratory to immediately stop testingFederal agency specimens. Threecommenters objected to using the termimminent harm because they believethe term limits the Departments ability

to suspend a laboratory or IITF.Although the Department hassuccessfully suspended a number oflaboratories using imminent harm asthe basis for an immediate suspension,the term has been removed from theseGuidelines. The reasons for takingaction against a laboratory or IITF aremore appropriately discussed inSections 9.12, 9.13, and 9.14. TheDepartment has revised Section 9.2(c) toclarify the requirements when alaboratory or IITF does not maintain itsHHS certification.

Section 9.3 (Section 9.5 of theProposed Revisions to Mandatory

Guidelines) describes the compositionrequirements for the PT samples that areused to challenge a laboratory or IITFsdrug and specimen validity tests. Therequirements in this section are thesame as those contained in the currentGuidelines, except for the pHspecifications in Section 9.3(b)(2). Thesespecifications were revised to challengethe pH tests used by IITFs, as describedin Section 12.14(c)(1), as well aslaboratory pH screening tests with anarrow dynamic range, as described inSection 11.18(c)(1).

Section 9.4 (Section 9.9 of the

Proposed Revisions to MandatoryGuidelines) describes the requirementsthat an applicant laboratory must satisfywhen testing the 3 consecutive sets ofPT samples sent to the laboratory duringthe initial certification process. Section9.5 (Section 9.13 of the ProposedRevisions to Mandatory Guidelines)describes the requirements that acertified laboratory must satisfy whentesting the quarterly sets of PT samplessent to the laboratory as part of themaintenance PT program. In bothsections, the requirements are the same


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as in the current Guidelines with twoexceptions concerning the evaluation ofspecific gravity results. The Departmenthas retained the acceptable range of nomore than 0.0003 specific gravity unitsfrom the mean for PT samples with amean less than 1.0100, but hasincreased the acceptable range to0.0004 specific gravity units when a PT

samples mean is equal to or greaterthan 1.0100. The Department hasretained the limit of0.0006 specificgravity units from the mean forassessing errors for PT samples with amean less than 1.0100, but hasincreased the limit to 0.0007 specificgravity units when the PT samplesmean is equal to or greater than 1.0100.The Department has been evaluating theperformance of the instruments used tomeasure specific gravity to 4 decimalplaces and believes increasing theprecision limits for high specific gravityreadings is reasonable and appropriate

due to the nature of the refractive indexand calibration methods using oil tocalibrate the instruments.

Section 9.6 (Section 9.17 of theProposed Revisions to MandatoryGuidelines) describes the PTrequirements an applicant IITF mustsatisfy to conduct urine testing andSection 9.7 (Section 9.21 of theProposed Revisions to MandatoryGuidelines) describes the PTrequirements that an HHS-certified IITFmust satisfy to conduct urine testing.Both sections were revised to beconsistent with PT challenges for theinitial testing part of a laboratory (i.e.,

requirements addressing confirmatorytest challenges were deleted). Onecommenter noted the requirement tocorrectly identify and report the totaldrug challenges over 3 sets of PTsamples was 80 percent for applicantand certified IITFs, while it is 90percent for applicant and certifiedlaboratories. The commenterrecommended that the requirement bethe same for IITFs and laboratories. TheDepartment agrees and has revised therequirement in Section 9.6(a)(1) to be 90percent for applicant IITFs for initialtesting.

Section 9.8 (Section 9.22 of theProposed Revisions to MandatoryGuidelines) describes the inspectionrequirements for an applicant laboratoryor IITF and Section 9.9 (Section 9.23 ofthe Proposed Revisions to MandatoryGuidelines) describes the inspectionrequirements for an HHS-certifiedlaboratory or IITF. The ProposedRevisions to Mandatory Guidelinesrequired using at least two inspectors toinspect an applicant laboratory or IITF.Three commenters expressed concernwith requiring at least two inspectors to

inspect an applicant laboratory or IITF,while the Proposed Revisions toMandatory Guidelines permit only oneinspector to potentially be used toinspect an HHS-certified laboratory orIITF. The Department has revisedSection 9.8 to require two inspectorsrather than the proposed at least twoinspectors. The Department believes

that the inspection of an applicantlaboratory or IITF must be conductedusing two inspectors because thisminimizes the possibility of a laboratoryor IITF disputing the findings of oneinspector as opposed to the findingsfrom two inspectors. With regard toHHS-certified laboratories and IITFs, theDepartment retained the ProposedRevisions to Mandatory Guidelinesrequirement which states that an HHS-certified laboratory or IITF is inspected

by one or more inspectors. TheDepartment believes that one inspectoris appropriate to inspect an HHS-

certified laboratory or IITF when thefacility is very small, has an extremelysmall workload, and has a history ofacceptable performance on testing thePT samples and on previousinspections. The Department believesthat using one inspector is sufficient toconduct a thorough inspection andmakes it cost-effective for very smallHHS-certified laboratories and IITFs toremain in the certification program.

Section 9.10 specifies the criteria anindividual must satisfy to be eligible forselection as an inspector for theSecretary under these Guidelines. Thissection also states that the Secretary of

a Federal Agency may inspect an HHS-certified laboratory or IITF at any time.The requirements in this section are thesame as in Section 9.24 of the ProposedRevisions to Mandatory Guidelines, butthe section has been reworded forclarity.

Section 9.11 describes what happenswhen an applicant laboratory or IITFfails to satisfy the minimumrequirements for either the PT programor the inspection program. TheDepartment believes that an applicantlaboratory or IITF must successfullysatisfy all of the initial certification

process requirements or be required tobegin the process from the verybeginning. That is, submit a newapplication with corrective actionsindicated and then successfully satisfythe requirements for the 3 sets of PTsamples. These requirements are thesame as in the Proposed Revisions toMandatory Guidelines, Section 9.25.

Section 9.12 describes what happenswhen a certified laboratory or IITF doesnot satisfy the minimum requirementsfor either the PT program or theinspection program. The policy in this

section is the same as that contained inthe current and Proposed Revisions toMandatory Guidelines in Section 9.26.

Section 9.13 describes the factors thatare considered when determiningwhether to revoke a laboratorys orIITFs certification. The factorsdescribed are the same as thosecontained in the current and Proposed

Revisions to Mandatory Guidelines inSection 9.27.

Section 9.14 states that the Secretarymay suspend a laboratorys or IITFscertification to protect the interests ofthe United States. This policy is thesame as that contained in the currentand Proposed Revisions to MandatoryGuidelines in Section 9.28.

Section 9.15 describes how theSecretary notifies a laboratory or IITFthat action is being taken against thelaboratory or IITF. The policy in thissection is the same as the policydescribed in the current and ProposedRevisions to Mandatory Guidelines inSection 9.29.

Section 9.16 describes how alaboratory that has had its certificationrevoked can apply for recertification.The policy is the same policy asdescribed in the current and ProposedRevisions to Mandatory Guidelines inSection 9.30.

Section 9.17 states that the list ofHHS-certified laboratories and IITFswill be published monthly in theFederal Register. This policy is thesame policy as described in the currentand Proposed Revisions to MandatoryGuidelines in Section 9.31.

Subpart JBlind Samples Submitted byan Agency

Section 10.1 describes therequirements for Federal agencies tosubmit blind samples to certifiedlaboratories or IITFs. Four commentersexpressed concern that the proposedrequirement to submit only 1 percent

blind samples was too low. TheDepartment agrees and has revisedSection 10.1(b) to require each agency tosubmit 3 percent blind samples eachyear rather than having one requirementfor the first 90 days (3 percent) and a

different requirement after 90 days (1percent). The Department also notes thatthe HHS-certified laboratories and IITFswill also be evaluated using quarterlyPT samples and will be receiving the 3percent blind samples from severalagencies to ensure that they are properlyhandling and testing donor specimens.The policy in Section 10.1(c) describingthe percentage of negative, positive, andadulterated or substituted blind samplesto be submitted was revised. Theproposed 80 percent negative blindsamples was changed to 75 percent


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negative blind samples, and 20 percentnon-negative was changed to 15 percentpositive and 10 percent adulterated orsubstituted.

Section 10.2 describes the specificrequirements for each blind sample andthe requirements are the same as thosecontained in the current and ProposedRevisions to Mandatory Guidelines.

Section 10.3 describes how a collectorsubmits a blind sample to be tested. Therequirements in this section are thesame as those in the Proposed Revisionsto Mandatory Guidelines. Section 10.4describes what happens when aninconsistent result is reported on a blindsample. The requirements in thissection are the same as those in theProposed Revisions to MandatoryGuidelines.

Subpart KLaboratory

Section 11.1 requires each certifiedlaboratory to have a standard operating

procedure manual and describes whatinformation must be contained in themanual. The requirements in thissection are the same as those in thecurrent and Proposed Revisions toMandatory Guidelines.

Section 11.2 describes theresponsibilities of the individual whohas responsibility for the day-to-daymanagement of the urine drug testinglaboratory. This individual is called theresponsible person (RP). Theresponsibilities described in this sectionare the same as those described in thecurrent and Proposed Revisions to

Mandatory Guidelines, except therequirement that the RP qualify as acertifying scientist was moved toSection 11.3(e). The Department

believes the requirement that the RPqualify as a certifying scientist is moreappropriately included as aqualification rather than aresponsibility.

Section 11.3 describes the scientificqualifications that an individual musthave to serve as an RP. Threecommenters believe the requirement foran RP to have experience with thecollection and analysis of biological

specimens is too general. TheDepartment believes the qualification asstated in Section 11.3(b) is appropriateand does not need to specifically focuson collecting urine specimens. Theprimary purpose for this qualification isthat the RP has experience andknowledge of the general proceduresand issues that may arise with thecollection and analysis of biologicalspecimens (e.g., chain of custody,storage, handling, troubleshootingproblems). The qualifications describedin this section are the same as those

described in the current and ProposedRevisions to Mandatory Guidelines.

Section 11.4 describes what happenswhen an RP is absent or leaves acertified laboratory. This section has

been revised to require a laboratory tohave multiple RPs or one RP and analternate RP. The requirement in theProposed Revisions to Mandatory

Guidelines did not make it clear that thelaboratory must have an alternate RPwhen there is only one RP. TheDepartment believes this requirementand establishing time limits for thealternate RP to assume RP duties whenan RP is absent from a laboratory willminimize the impact on the laboratory,and enable the laboratorys continuedcompliance with the Guidelines whenthe RP is absent. The Department hasrevised Section 11.4(c) to state that analternate RP must be found acceptableduring an on-site inspection of thelaboratory. This requirement ensures

that the alternate RP is pre-approved.The Department believes an individualmust be pre-approved as an alternate RPto ensure that someone with theappropriate knowledge andqualifications can assume RPresponsibilities when the RP is absentfrom the laboratory.

Section 11.5 describes thequalifications an individual must haveto certify a result reported by an HHS-certified laboratory. An individual whocertifies results may be either acertifying scientist (CS) or a certifyingtechnician (CT) depending on the typeof test result he or she is certifying. The

Department has decided to retain thebachelors degree or equivalentrequirement for the certifying scientistqualifications as described in thecurrent Guidelines. The Department

believes the training and experiencespecified in the Proposed Revisions toMandatory Guidelines for a CT aresufficient to ensure that the CT canproperly certify a negative, negative/dilute, or rejected for testing result. Onecommenter stated that the qualificationsfor a CT in an HHS-certified laboratorywere not consistent with thequalifications for a CT in an HHS-

certified IITF as described in theProposed Revisions to MandatoryGuidelines. The same requirements arespecified for a CT in the laboratory andIITF sections (i.e., Sections 11.5(b) and12.5, respectively). The Department hasfurther clarified that qualifications for aCT are the same in a laboratory and inan IITF by revising the definition for acertifying technician in Section 1.5. Therevised definition states that a CT canverify negative, negative/dilute, andrejected for testing results reported by alaboratory or IITF.

Section 11.6 describes thequalifications and training otherlaboratory personnel must have. Thepolicy in this section is the same as thepolicy described in the current andProposed Revisions to MandatoryGuidelines, except that the current andProposed Revisions to MandatoryGuidelines do not specifically state that

the training must be documented.Section 11.7 describes the security

measures that a certified laboratorymust maintain. This section has beenrevised to require the authorized escortto enter his or her name in the recordused to document the entry ofauthorized visitors. The current andProposed Revisions to MandatoryGuidelines did not require suchdocumentation.

Section 11.8 describes internallaboratory chain of custodyrequirements. The policy in this sectionis the same as the policy in theProposed Revisions to MandatoryGuidelines.

Section 11.9 describes the tests anHHS-certified laboratory must conducton a specimen received from an IITF.Three commenters expressed concernwith requiring an HHS-certifiedlaboratory to conduct only theconfirmatory test(s) on specimensreceived from an HHS-certified IITF.The commenters recommended that anHHS-certified laboratory test allspecimens received from an HHS-certified IITF as if the specimens hadnot been previously tested. Thecommenters believe it is important that

all analytical results supporting apositive, adulterated, substituted, orinvalid result should be generatedwithin the same facility. TheDepartment agrees and has revised thissection to require an HHS-certifiedlaboratory to test each specimenreceived from an HHS-certified IITF inthe same manner as if it had not beenpreviously tested. This revision ensuresthat the final analytical results (both theinitial and confirmatory data) andinternal chain of custody documents aregenerated by one HHS-certifiedlaboratory and can be properly reviewed

and certified before the test result isreleased.Section 11.10 describes the

requirements for an initial drug test.One commenter stated that paragraph(c) of the Proposed Revisions toMandatory Guidelines did not clearlystate that the initial drug test kits must

be FDA-cleared. The Departmentagrees and clarified that drug tests must

be approved, cleared, or otherwiserecognized by FDA as accurate andreliable for the testing of a specimen foridentifying drugs of abuse or their


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metabolites. Therefore, it is moreappropriate to refer to FDArequirements rather than limit thelanguage to FDA-cleared. We notethat only those test kits subject to FDApremarket notification requirementsmust be FDA-cleared. One commenter

believes that the purpose for conductinga second initial test was not clearly

stated in paragraph (d). The Departmentagrees and has revised this paragraph toindicate that a second initial drug testmay be used when the second initialdrug test has a different specificity thanthe first initial drug test. The secondinitial test must satisfy the batch qualitycontrol requirements for an initial drugtest.

Section 11.11 describes what alaboratory must do to validate an initialdrug test before using it to test donorspecimens. One commenterrecommended that the requirements tovalidate an initial drug test should be

more stringent. The Department believesthese requirements are appropriate andthat they give an HHS-certifiedlaboratory the flexibility it needs tovalidate the initial drug tests based onthe instruments they are using. TheDepartment also moved the requirementfrom Section 11.13 to document theeffect of carryover to this section,

because it is more appropriate toevaluate the possibility of carryoverwhen the initial drug test is validated.Knowing when and if carryover canaffect donor specimen results allows alaboratory to determine when correctiveaction must be taken to control for

carryover.Section 11.12 describes the batch

quality control requirements whenconducting initial drug tests. Therequirements in this section are thesame as those described in the currentand Proposed Revisions to MandatoryGuidelines.

Section 11.13 describes therequirements for a confirmatory drugtest. Four commenters disagreed withallowing the use of otherchromatographic separation and massspectrometry techniques for theconfirmatory drug tests. They believe

that gas chromatography/massspectrometry (GC/MS) has been the goldstandard since the Federal WorkplaceDrug Testing Program began and should

be the only accepted confirmatorymethod until other methods are provento be reliable and scientificallysupportable. The Department disagreesand believes that other methods, such asliquid chromatography/massspectrometry (LC/MS), LC/MS/MS, andGC/MS/MS, have been proven to bereliable to test specimens. While GC/MSremains the most common confirmatory

testing technology used in forensic drugtesting laboratories, the Departmentdoes not want to prohibit laboratoriesfrom using technologies that provideforensically and scientificallysupportable results. The Departmentproposed that these additionaltechnologies be allowed in Federalworkplace drug testing programs only

after a thorough review of extensiveinformation obtained through technicalworking groups consisting of drugtesting and analytical chemistry experts.No comments were submitted thatjustified removal of these technologiesfrom the proposed Guidelines. Since theproposed revisions to the Guidelineswere published in April 2004, the useof these technologies has become evenmore widespread and there have beennumerous studies employing thesemethods, providing additional data todemonstrate their forensic and scientificacceptability. These methods may offer

some benefits over traditional GC/MSmethods. For example, GC and LCprovide a means to separate drugs ofabuse from other compounds found inurine. The advantage of LC methods isthat they may require less specimenpreparation prior to analysis, therebysaving time and costs. Likewise MS andMS/MS methods are highly selective,reducing the chance that othersubstances present in the urine mightinterfere with the analysis and preventthe laboratory from obtaining a validresult. MS/MS technology provides anadvantage in that it is also more

sensitive than GC/MS. A properlyvalidated and controlled GC/MS methodis sensitive enough to meet therequirements of these Guidelines forforensic urine drug testing. However,the increased sensitivity provided byMS/MS can enable laboratories to useless specimen volume, which may haveimplications in some cases (e.g., whenthere are multiple drugs present in aspecimen). Furthermore, manylaboratories have implementedinstruments and test methods usingthese different chromatographic and/ormass spectrometric technologies forforensic applications other thanfederally regulated workplace testing.Therefore, laboratories that are currentlycertified or plan to seek certificationunder these Guidelines may alreadyhave the experience and capability toemploy these methods in Federalworkplace testing programs or they maywant to add these newer technologies totheir testing protocols.

Section 11.14 describes what alaboratory must do to validate aconfirmatory drug test before using it totest donor specimens. The Department

moved the requirement from Section11.16 to document the effect of anycarryover to this section, because it ismore appropriate to evaluate thepossibility of carryover when theconfirmatory drug test method isvalidated. Knowing when and ifcarryover can affect donor specimenresults allows a laboratory to determine

when corrective action must be taken tocontrol for carryover.

Section 11.15 describes the batchquality control requirements whenconducting confirmatory drug tests.Three commenters recommended thatthis section be revised to allow using amulti-point calibration as well as asingle-point calibration for each batch ofspecimens when conducting aconfirmatory test. The Departmentagrees and has revised Section11.15(a)(1) to read A calibrator with itsdrug concentration at the cutoff. Thisrevision allows multi-point calibration,

while still requiring a cutoff calibrator.Section 11.16 describes the analyticaland quality control requirements forconducting specimen validity tests. Therequirements are the same as thosedescribed in the current Guidelines,except that Section 11.16(b) specificallyrefers to the requirements specified inSection 11.18 rather than simply statingthat appropriate calibrators and controlsmust be included. The Department

believes this revision will ensure thateach laboratory will use the samecalibrators and controls whenconducting specimen validity tests.

Section 11.17 is a new section that

describes what a certified laboratorymust do to validate a specimen validitytest. The Department is establishingthese requirements to ensure thatspecimen validity tests, like drug tests,are validated before they are used fordonor specimens. The policy has beenintentionally written as a generalrequirement because each type ofspecimen validity test has differentperformance characteristics.

Section 11.18 describes therequirements for conducting each typeof specimen validity test on a urinespecimen. One commenter

recommended allowing an HHS-certified laboratory to use a threedecimal place refractometer as apreliminary specific gravity test todetermine if the initial specific gravitytest must be conducted. The Departmentagrees and has revised Section11.18(b)(1) to allow a laboratory to usea refractometer measuring to at leastthree decimal places as a specificgravity screening test when thecreatinine is greater than 5.0 mg/dL andless than 20 mg/dL. However,laboratories must use a four decimal


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place refractometer to measure specificgravity for specimens when the initialcreatinine test result is equal to or lessthan 5.0 mg/dL or when the screeningspecific gravity test result using a threedecimal place refractometer is less than1.002. These criteria were selected fordeciding whether a three or fourdecimal refractometer must be used

because the test results are approachingthe criteria for reporting a substitutedspecimen which may lead to adversepersonnel action. The Department alsoadded the quality control requirementsfor conducting the specific gravityscreening test. One commenterrecommended that colorimetric specificgravity assays be permitted for use asthe initial specific gravity test. TheDepartment disagrees because theseassays lack the required accuracy andprecision to serve as an initial specificgravity test. One commenterrecommended that pH meters used for

the initial and confirmatory pH testsshould print a paper copy report or beinterfaced with a LaboratoryInformation Management System (LIMS)or computer. The commenter noted thatthe Guidelines include this requirementfor refractometers used to conduct theinitial and confirmatory specific gravitytests, and the same forensicconsiderations apply for pH tests. TheDepartment agrees and has addedSection 11.18(c)(2) specifying that a pHmeter used for the initial andconfirmatory pH tests must report anddisplay pH to at least one decimal place,

and must be interfaced with a LIMS orcomputer, and/or generate a paper copyof the digital electronic display todocument the numerical values of thepH test results.

Section 11.19 describes therequirements for a certified laboratory toreport results to an MRO. Onecommenter was opposed to requiring anHHS-certified laboratory to provide theconcentration of a drug in a specimen atthe time the test result is reported to theMRO. The Department disagrees and

believes this policy is appropriatebecause, in keeping with the paperwork

reduction and elimination acts, iteliminates the need for the MRO togenerate a request in writing to obtainthe concentrations for positivespecimens. One commenter stated thatreporting a positive and invalid resulton the same specimen is confusing andrecommended that the positive resultand the reason for the invalid result

be reported, rather than using the terminvalid result along with the reasonfor the invalid result. The Departmentrecognizes that requiring the laboratoryto report both results to the MRO may

be confusing; however, the MRO mustdiscuss both results with the donor. Theinvalid result may only have an impacton the testing of the split specimen ifrequested by the donor. One commenterrecommended that specific guidance beincluded on the content of anycomputer-generated report. TheDepartment does not believe detailed

guidance is needed, but has revised theappropriate Section 11.19(o) to state thatthe computer-generated report mustcontain sufficient information to ensurethat the test result is properly associatedwith the Federal CCF that the MROreceived from the collector. TheDepartment added Section 11.19(g) tomaintain the policy in the currentGuidelines which requires thelaboratory to contact the MRO prior toreporting specimens meeting certaininvalid result criteria. This policy isimportant to ensure that the laboratoryand the MRO discuss those specimens

for which a positive or adulteratedresult could be determined, usingdifferent or additional tests at anothercertified laboratory. If additional testingdoes not appear to be feasible, thelaboratory reports the invalid result. TheMRO can initiate action immediatelyupon receipt of the report, inaccordance with Section 13.4.

Section 11.20 describes how long acertified laboratory must retain aspecimen. Section 11.20(c) was revisedto require a Federal agency to specify aperiod of time rather than anadditional period of time whenrequesting a laboratory to retain a

specimen beyond the normal one yearspecimen storage period. Also, thestatement that a laboratory mustmaintain any specimen under legalchallenge for an indefinite period oftime has been deleted. The laboratorymust be instructed by the agency as tothe period of time the specimen underlegal challenge will need to be retained

beyond the normal one year storageperiod.

Section 11.21 describes how long acertified laboratory must retain records.This section has been revised to specifythe records that the HHS-certified

laboratory must maintain when there isa legal challenge to the test result for aparticular specimen. The revisionallows a Federal agency to request alaboratory to maintain a copy of thedocumentation package for thespecimen result being challenged for aspecified period of time. The revisionalso permits the HHS-certifiedlaboratory to retain records other thanthose included in the documentationpackage beyond the 2 year period oftime that records are normallymaintained.

Section 11.22 describes the statisticalsummary report that a certifiedlaboratory must provide to an agency.The summary report is the same as thereport described in the current andProposed Revisions to MandatoryGuidelines. Four commenters expressedconcern with requiring an HHS-certifiedlaboratory to make qualified personnel

available to testify in a proceedingagainst a Federal employee. They wereconcerned that several individuals may

be required to testify, thereby disruptingthe laboratorys ability to continuetesting specimens. The Departmentagrees and has revised Section 11.22(d)to require an HHS-certified laboratory tomake only one qualified individualavailable to testify. This change isconsistent with what normally happensin proceedings where laboratory resultsare being challenged by a donor.

Section 11.23 describes theinformation a laboratory must make

available to a Federal employee. TheDepartment has revised this section torequire that the curriculum vitae for theresponsible person(s) be inclu

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