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accordance with the objectives of these DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: procedures. HUMAN SERVICES Background Section 4.13 Administrative Record Substance Abuse and Mental Health The Mandatory Guidelines for Federal Services Administration The administrative record of review Workplace Drug Testing Programs (Guidelines) were first published in the consists of the review file; other Proposed Revisions to Mandatory submissions by the parties; transcripts Federal Register on April 11, 1988 (53 Guidelines for Federal Workplace Drug FR 11970), and have since been revised or other records of any meetings, Testing Programs conference calls, or oral presentation; in the Federal Register on June 9, 1994 evidence submitted at the oral AGENCY: Substance Abuse and Mental (59 FR 29908), and on September 30, presentation; and orders and other Health Services Administration, HHS. 1997 (62 FR 51118). The Guidelines documents issued by the reviewing and ACTION: Notice of proposed revisions to establish the scientific and technical presiding officials. mandatory guidelines. guidelines for Federal workplace drug testing programs and establish standards Section 4.14 Written Decision SUMMARY: The Department of Health and for certification of laboratories engaged Human Services (‘‘HHS’’ or in urine drug testing for Federal (a) Issuance of Decision. The ‘‘Department’’) is proposing to establish agencies under authority of Pub. L. 100– reviewing official shall issue a written scientific and technical guidelines for 71, 5 U.S.C. section 7301 note, and E.O. decision upholding or denying the the testing of hair, sweat, and oral fluid 12564. suspension or proposed revocation. The specimens in addition to urine In developing and organizing the decision will set forth the reasons for specimens; scientific and technical proposed revisions to the Guidelines, the decision and describe the basis guidelines for using on-site tests to test there are a number of issues presented therefor in the record. Furthermore, the urine and oral fluid at the collection in this preamble, that include the reviewing official may remand the site; requirements for the certification of rationale for the order and manner of matter to the respondent for such instrumented initial test facilities; and presentation of what is proposed and further action as the reviewing official added standards for collectors, on-site why. These issues are first presented by deems appropriate. testers, and medical review officers. general topic area, and later presented (b) Date of Decision. The reviewing DATES: Submit comments on or before in summary, as they appear in the text official will attempt to issue his or her July 12, 2004. of the proposed Guidelines. decision within 15 days of the date of ADDRESSES: You may submit comments, the oral presentation, the date on which History of the HHS Certification identified by (insert docket number and/ Program for Federal Employee Drug the transcript is received, or the date of or RIN number), by any of the following the last submission by either party, Testing Programs, and Related methods: Knowledge whichever is later. If there is no oral • E-mail: [email protected]. Include presentation, the decision will normally docket number and/or RIN number in Since the beginning of the program in be issued within 15 days of the date of the subject line of the message. 1988, many challenges have been receipt of the last reply brief. Once • Fax: 301–443–3031 overcome and lessons learned from the issued, the reviewing official will • Mail: 5600 Fishers Lane, Rockwall specific and rigorous HHS certification immediately communicate the decision II, Suite 815, Rockville, Maryland of laboratories to perform forensic to each party. 20857. workplace testing for job applicants and (c) Public Notice. If the suspension • Hand Delivery/Courier: 5515 Executive Branch Federal employees. and proposed revocation are upheld, the Security Lane, Suite 815, Rockville, The initial Guidelines were published revocation will become effective Maryland 20852. for a 60-day public comment period, immediately and the public will be • Information Collection and were first published as a final notified by publication of a notice in the Requirements: Submit comments to the notice in the Federal Register in April Federal Register. If the suspension and Office of Information and Regulatory of 1988. Originally, it was believed that proposed revocation are denied, the Affairs, OMB, New Executive Office fewer than 10 laboratories would apply revocation will not take effect and the Building, 725 17th Street, NW., for HHS certification under the suspension will be lifted immediately. Washington, DC 20502, Attn: Desk Guidelines to conduct Federal employee Public notice will be given by Officer for SAMHSA. Because of delays drug testing, and that the Department publication in the Federal Register. in receipt of mail, comments may also would not require even that many to test be sent to 202–395–6974 (fax). the urine specimens from all Federal Section 4.15 Court Review of Final Instructions: All submissions received agencies. Administrative Action; Exhaustion of must include the agency name and This situation changed very quickly Administrative Remedies docket number or Regulatory when the Department of Transportation Information Number (RIN) for this Before any legal action is filed in (DOT) published a final drug testing rulemaking. All comments will be rule (54 FR 49854) in December 1989 for court challenging the suspension or available for public review at 5515 proposed revocation, respondent shall its regulated transportation industries. Security Lane, Suite 815, Rockville, DOT required its regulated industries to exhaust administrative remedies Maryland 20852. provided under this subpart, unless use drug testing laboratories that were FOR FURTHER INFORMATION CONTACT: otherwise provided by Federal Law. The certified by HHS. This requirement reviewing official’s decision, under Walter F. Vogl, Ph.D., Drug Testing began a close relationship between HHS section 4.9(e) or 4.14(a), constitutes final Section, Division of Workplace and DOT. Additionally, the Nuclear agency action and is ripe for judicial Programs, CSAP, 5600 Fishers Lane, Regulatory Commission (NRC) in its review as of the date of the decision. Rockwall II, Suite 815, Rockville, Fitness for Duty program contained in Maryland 20857, 301–443–6014 (voice), 10 CFR Part 26 requires its licensees to [FR Doc. 04–7985 Filed 4–6–04; 12:39 pm] 301–443–3031 (fax), [email protected] use drug testing laboratories certified by BILLING CODE 4162–20–P (e-mail). HHS.

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As the Guidelines received both Department began, as discussed below, presented at the June 2000 DTAB public and judicial support, the private a dedicated assessment of drug testing meeting. The initial, work-in-progress sector chose to incorporate the using alternative specimens and drug draft Guidelines were placed on our requirement to use only a laboratory testing technologies, including head web site and the public was invited to that has HHS certification under the hair, oral fluid (saliva), and sweat, for submit supplemental information and Guidelines, for employee drug testing. possible application in Federal informal comments to help improve our Between July 1988 and early 1990, 50 workplace drug testing programs. knowledge base. Twenty-eight separate laboratories had received HHS commenters submitted comments on the The Added Specimens—Major Change certification under the Guidelines, first working draft. The comments were while another 100 laboratories were The Department proposes to expand summarized and presented at the next awaiting certification. the kinds of specimens that may be DTAB meeting held in September 2000. In developing the preamble for the tested under Federal agency workplace At the September 2000 DTAB meeting, proposed expansion and revision of the drug testing programs. The proposed the second working draft of the Guidelines, it has been very helpful to addition of head hair, oral fluid, and Guidelines was presented and, again, keep in sight important areas of sweat specimens are the result of a comments were requested from all consideration that have remained directed Department process that began interested parties. At the December 2000 visible as the program matured over the with a 3-day scientific meeting of the DTAB meeting, the public comments ensuing fifteen years. These include, but DTAB held in April 1997 to discuss submitted were used to prepare the are not limited to, custody and control drug testing of alternative specimens third working draft of the Guidelines. that ensures donor specimen identity and using new testing technologies as As the DTAB continued to work on and integrity, specimen collection they apply to workplace drug testing the Guidelines, the Department initiated procedures, analytical testing methods, programs. The entire meeting was open a voluntary pilot PT program. PT quality control and quality assurance, to the public. The first two days samples were developed and produced reporting results, the role of the medical consisted of presentations on the at government expense. The PT samples review officer (MRO), and HHS principles and criteria of workplace were sent to several laboratories for certification issues that include testing drug testing program requirements and testing at the laboratories’ own expense, site inspections and performance testing industry representatives discussing using the procedures that they routinely (PT) samples. alternative specimens (hair, oral fluid, use to test head hair, oral fluid, and The Department has remained sweat as well as urine) and technologies sweat specimens. This pilot PT program committed to maintaining the integrity (non-instrument based on-site tests). began in April 2000 and was necessary of the entire Drug-Free Federal The presentations focused on the for two reasons. First, it was necessary Workplace Program by identifying and following areas for each specimen/ to determine if it was possible to using the most accurate, reliable drug technology: specimen collection and prepare stable and accurate PT samples testing technology available. To chain of custody, initial test reagents for the different types of specimens that accomplish that goal, the Department and procedures, confirmatory test would be needed as part of a laboratory collaborates with the DOT, NRC, procedures, internal quality control certification program. Second, the Federal regulators, researchers, the program, reporting test results, results reported by the laboratories testing industry, and both public and interpreting test results, and external would indicate if the PT program could private sector employers on an on-going quality assurance program. Industry establish credibility, precision, basis on scientific and program matters. coordinators selected the presenters for accuracy, and reliability in drug testing As the number and types of commercial the alternative specimens and with alternative specimens. Based on workplace drug testing products and technologies to ensure a thoroughly the information obtained from four testing options have increased over the unbiased review based on the science rounds of PT samples, it appears that past decade, the Department, through available. On the third day, the public valid PT samples can be prepared, SAMHSA’s Drug Testing Advisory was given an opportunity to make although some further refinement is Board (DTAB), has expressed increasing official statements or comments. needed, and that over time some interest in assessing these new products Following this meeting, the DTAB laboratories testing alternative and procedures for possible use in members continued reviewing the large specimens have been able to achieve Federal agency employee testing amount of information presented at the performance levels approaching those programs. meeting. Their efforts resulted in the levels applied to urine testing Laboratory-based testing using identification of specific requirements laboratories. The criteria for laboratory- automated screening tests at necessary for the scientific, based hair, oral fluid, and sweat testing, instrumented initial test facilities (IITFs) administrative, and procedural integrity and for POCT urine and oral fluid tests was proposed by the same group of of a comprehensive workplace drug have been developed and proposed by individuals that developed the testing program, which includes the industry-lead working groups. Guidelines as an area of interest alternative specimens and technologies. Although performance in the pilot PT immediately after the Guidelines were They developed a chart summarizing program has been encouraging, with first published in 1988. At that time, the workplace drug testing program individual laboratory and group industries regulated by the NRC began requirements, reviewed the technical performance improving over time, there using this approach as part of their materials submitted to them, and are still three serious concerns. First, the Fitness for Duty programs to allow job identified the necessary workplace drug data from the pilot PT program to date applicants access to nuclear power testing requirements for each alternative show that not all participants have plants. A study of 10 sites (including specimen/testing technology. developed the capability to test for all both NRC licensee and other private The DTAB has continued its required drug classes, nor to perform sector sites) was conducted where such evaluation of the information submitted such tests with acceptable accuracy. an IITF was used. Point of collection by the industry representatives on Second, some drug classes are more test (POCT) devices were also being alternative specimens and technologies difficult to detect than others, for any developed, but with non-instrumented, since September 1997. The first working given type of specimen. Third, the visually read end-points. By 1997, the draft of the new Guidelines was specific drug classes that are difficult to

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detect varies by the type of specimen. confirmed with a more sophisticated contact with hair as it develops in and That means that special awareness will technique, most frequently by gas emerges from the skin. Sweat and be required to select the most chromatography/mass spectrometry sebum can deposit drugs and/or appropriate type of specimen to be (GC/MS). Tandem mass spectrometry metabolites on the hair shaft that in turn collected from a specific donor, when (MS/MS) using GC or liquid are absorbed into the hair shaft during use of a specific drug is suspected. This chromatography (LC) separation has and after its formation. Sweat can be public comment period is intended to emerged in recent years as the testing responsible for drug incorporation at provide an opportunity for all interested method of choice in order to increase distal segments of hair which does not parties to review the testing criteria and sensitivity and selectivity and to correspond to the time of drug associated specimen-specific analyze polar compounds without ingestion. procedures, to be sure that required derivitization.10,15,16 There are a number of factors that performance is achievable and Hair consists of a hair follicle and hair may influence the amount of drug sustainable when implemented. shaft. At the base of the follicle (bulb) incorporated into hair (e.g., drug dose, are highly vascularized matrix cells. As length of exposure, drug chemical Alternative Specimens matrix cells in the dermis of the skin structure, charge). Of particular concern The use of specimens other than urine move outward during growth, they form are environmental contamination and in workplace drug testing programs layers of a hair shaft that include the the role of hair color. have become a frequent topic in outer protectant cuticle, central cortex Concern has been raised about scientific meetings worldwide. This and inner medulla. Hair grows in three environmental contamination where a includes organizations such as the stages: about 85 percent of hair follicles person may claim, for example, that the Society of Forensic Toxicologists, The are in active growth (anagen), while the drug is present because the individual International Association of Forensic others are in a transition phase (catagen) was in a room where others were using Toxicologists, the Society of Hair before the resting phase (telogen). At the marijuana or cocaine. While washing Testing, and the American Academy of vertex region of the scalp, the average the hair sample may remove some of the Forensic Sciences. The most frequently growth rate of hair is about 0.4 contamination, ultimately we can discussed specimens are hair, oral fluid, millimeters per day or approximately 1 differentiate environmental and sweat. Until recently it was centimeter per month.1 The Department contamination from actual use because considered too soon for the forensic is proposing to permit agencies as part of the presence of the metabolite, which community to apply these alternative of their Federal workplace program to is not present when environmental specimens to workplace drug testing. test hair with lengths of about 1.5 inches contamination is the source of the drug. Current scientific literature provides long, representing a time period of 90 The role of hair color is also a major much of the information that was not days, and to use these specimens for concern. Melanin, which is responsible previously available in peer reviewed pre-employment, random, return-to- for pigmentation in hair, is produced in literature. Addition of these specimens duty, or follow-up testing. the hair bulb and incorporated into the to the Federal Workplace Drug Testing Analytes for the regulated drugs cells that form the cortex and medulla Program would complement urine drug tested in hair are marijuana metabolite during growth of the hair shaft. Melanin testing and aid in combating the threat (delta-9-tetrahydrocannabinol-9- is a polyanionic polymer of two types: from industries devoted to suborning carboxylic acid (THCA)), cocaine eumelanin and pheomelanin, the drug testing through adulteration, (parent drug and metabolites quantity of each determine hair color. substitution, and dilution. (benzoylecgonine, norcocaine, and Eumelanin concentration is highest in The preamble provides a list of cocaethylene)), phencyclidine (parent black hair and lowest in red hair while scientific studies that were used in drug (PCP)), opiates (codeine, morphine, pheomelanin concentration is highest in making the policy decisions. The and heroin metabolite (6- red hair and lowest in black hair.2 Department asks whether commenters acetylmorphine (6-AM)), and Melanin is absent in white hair. are aware of any other studies or data amphetamines (amphetamine, Animal studies have shown that hair that would cast more light on the methamphetamine, color influences drug incorporation appropriateness of using any of the methylenedioxymethamphetamine with black hair containing the most and alternative specimens or on limitations (MDMA), methylenedioxyamphetamine yellow (non-pigmented) hair the least.7 on how the specimens should be used. (MDA), and In vitro studies in which black, brown, methylenedioxyethylamphetamine and blond hair from drug-free human Hair (MDEA)). subjects were placed in a solution of The Department is proposing that hair Drugs and drug metabolites may be benzoylecgonine showed the highest testing be included in the Federal incorporated into hair by several concentration of the drug in black hair Workplace Drug Testing Program. Hair different pathways.1,3-7 As drugs and and the least in blond.8 Although there testing increases the time period over their metabolites travel through the have been a limited number of human which drug use can be detected as body in blood, they passively diffuse clinical controlled studies, data show compared to urine, sweat, or oral fluid. from the bloodstream into the base of that higher concentrations of some Hair is easily collected, transported and the hair follicle. Drugs and/or drugs are found in dark hair when stored, is less likely to transmit bio- metabolites are embedded into the hair compared to blond or red hair (e.g., organisms than urine or oral fluid, and as bands during the growth process. The codeine2, cocaine9, amphetamine10). is more difficult to adulterate than amount of drug in the hair band is The limited population studies urine. As separation techniques and proportional to the concentration in the published in peer reviewed literature at detection sensitivity and specificity blood when the hair was formed. The this time do not indicate a significant have improved, scientists are now able distance of the drug bands from the skin association between hair color or race to detect and quantify drugs and/or can estimate the time of drug use. Drugs and drug analyte.11 13 In one study, metabolites in hair at picogram levels. and/or metabolites may also be 1852 people that classified themselves Like other drug testing specimens, drugs incorporated into hair via secretions of as ‘‘black’’ or ‘‘white’’ showed no in hair are initially detected using an the apocrine sweat glands and evidence of a group adversely affected immunoassay technique and results are sebaceous glands, which are in close by hair testing, compared to urine

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testing, for cocaine and marijuana specimen volumes and amount of drug methods.34 Mechanical saliva testing.11 The examination of 500 are lower in oral fluid than in urine stimulation (i.e., chewing gum) can also positive hair samples for each of three specimens, current analytical methods lower drug concentrations in oral drugs (cannabinoids, cocaine, and (e.g., immunoassay, GC/MS, GC/MS/ fluid.33 To avoid saliva stimulation amphetamine) revealed little statistical MS, LC/MS/MS) have the required some recommend spitting into a cup, evidence of selective binding of drugs to sensitivity to be used for oral fluid but some donors may be opposed to hair of a particular color.12 Statistical specimen testing.23-26 spitting, especially when observed, and examination of 2791 data points that As with the other relatively new test may experience dry mouth. include heroin and its metabolites, specimens for drugs of abuse testing, The Department finds that the cocaine and its metabolites, MDMA and less is known about the collection difficulties associated with its analogs, and amphetamine and pharmacokinetics and disposition of oral fluid collection procedures are not methamphetamine failed to detect a drugs into oral fluid as compared to functionally different than other significant hair color effect.13 urine.3,28-30 Science shows that opiates, specimen collection difficulties Despite these suspected limitations, PCP, amphetamines and cocaine and currently encountered with urine. the Department still proposes to go most drugs including prescription Therefore, despite these known forward with incorporation of this new medications enter oral fluid through limitations, the Department proposes to technology as an alternative to urine for passive diffusion of the drug from the incorporate this new technology as an Federal agencies who may find it useful blood stream into the oral fluid. optional selection for Federal agencies in certain missions and tasks that only However, the active component of because oral fluid testing may be useful individual Federal agencies can marijuana (delta-9-tetrahydrocannabinol in certain missions and tasks that only identify. Though there continues to be (THC)) does not diffuse into oral individual Federal agencies can some question about the effect of hair fluid.26,31,32 The only way to detect identify. color on the amount of a drug or its marijuana use is through the presence of Sweat metabolite present in hair, there is no the parent drug (THC) in the oral fluid question about the fact that the drug or because the parent drug was present in The incorporation of drugs into sweat metabolite is present. The purpose of the oral cavity. Unfortunately, further is poorly understood but possible the Federal Workplace Drug Testing scientific study is needed to be able to mechanisms appear to be passive Program is to ensure the safety of the differentiate between whether the diffusion of drugs from blood into sweat workplace which it does in two ways. parent drug was present in the oral gland and transdermal migration of First, it identifies individuals in security cavity due to drug use or environmental drugs to the skin surface, where it is or safety sensitive positions who have contamination, i.e. the individual was dissolved in sweat.3,36,37 The time been using drugs, and second, it acts as present in a room when others smoked interval between drug consumption and a deterrent for people who might marijuana, for example. detection in sweat depends on the otherwise use drugs lest they be In order to protect Federal workers nature of the particular drug or drug detected. Hair testing can improve the from incorrect test results for marijuana, metabolite and the sensitivity of success of the program because it the Department proposes that a second analytical method used.3,36,38 increases the time period over which biological specimen, a urine specimen, Sweat may be collected as liquid drug use can be detected as compared will need to be collected under the perspiration,38 on sweat wipes,20,39 or to urine; it is easily collected, current Guidelines at the same time the with a sweat patch.40-44 Sweat collection transported and stored; it is less likely oral fluid specimen is obtained, is a non-invasive procedure 37,38 and to transmit bio-organisms than urine; primarily for the purpose of testing for privacy during collection does not and is more difficult to adulterate. marijuana when the oral fluid specimen appear to be a concern.38 Commercially is positive for marijuana. The available sweat patches may be worn for Oral Fluid Department will revise the Guidelines an extended period of time, are Testing methods for drugs in oral when the science is available to waterproof, and are generally accepted fluid have been developed in recent differentiate between actual use and by patients.39 Currently, there are a years and have been extensively used in environmental contamination. limited number of commercially some tested populations (e.g., Analytes for the regulated drugs available collection devices,20,39 only therapeutic drug monitoring, risk tested in oral fluid are marijuana (parent one of which is FDA-cleared. Attempts assessment in the insurance industry, drug (THC)), cocaine (parent drug or to remove or tamper with the FDA- and non-Federal workplace testing).17-19 metabolite benzoylecgonine), PCP cleared sweat patch are usually visible Many studies support the use of oral (parent drug), opiates (codeine, to personnel trained to remove them.3,37 fluid as a specimen for forensic drug morphine, and 6–AM), and Sweat patch contamination issues testing.20,21 amphetamines (amphetamine, continue to be a concern.3,39,45 For Oral fluid offers some advantages over methamphetamine, MDMA, MDA, example, one study suggests that sweat other types of specimens.22 Oral fluid is MDEA). patches are susceptible to readily accessible and its collection is The pH of oral fluid can affect contamination by a drug that is on the perceived as less invasive than a urine incorporation of some drugs.33-35 skin before the sweat patch is applied specimen collection. Oral fluid Salivary pH ranges from about 6.2 to and by absorption into the patch collections can easily be observed and, 7.4. Increased saliva flow rate raises the through the surface of the protecting therefore, the specimen is less pH up to a maximum of 8.0 due to membrane.39 Other studies indicate that susceptible to adulteration or higher bicarbonate levels. Oral fluid the polyurethane (outer) layer is substitution by the donor. Drugs can be collection devices cause some impermeable to molecules larger than detected in oral fluids within one hour stimulation of saliva flow. Studies have dimer water.45 Based on that of use making oral fluids useful in found that concentrations of drugs (e.g., information, the Department believes detecting very recent drug use.27 cocaine and its metabolites) in non- that external absorption of any drugs Substitution can be identified by stimulated oral fluid specimens were through the outer layer is not possible measuring an endogenous component greater than the concentrations of under normal circumstances. With (IgG) in the specimen. Although the specimens collected using other regard to contamination from a drug

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present on the skin before applying the environment.39 The amount of sweat required specimen validity tests, (8) use sweat patch, the Department proposes collected for testing is small and the HHS cutoffs, and (9) submit all non- that the skin area be washed with soap drug concentration low. Therefore, the negative specimens to a full service and cool water or with a disposable analytical procedures used for HHS-certified laboratory for required towelette. Then the collector must measurement of drugs and/or their additional testing. In meeting these thoroughly clean the skin area where metabolites in sweat must be very criteria, the IITF will meet Guideline the patches will be worn with alcohol sensitive. Confirmation of drug analytes requirements of the initial test section of wipes prior to application. However, the in sweat are routinely confirmed by GC/ an HHS-certified laboratory. Department encourages researchers to 54 MS and sometimes with LC/MS/ POCT for Drugs conduct further research in this area. MS.38 The Department knows from direct Currently, sweat testing is used in the POCT devices for drugs of abuse were experience both at the National Institute private sector for monitoring drug use first available in the early 1990s. POCTs on Drug Abuse and the Substance Abuse during substance abuse treatment 37 and include non-instrumented devices with and Mental Health Services is also used in the criminal justice visually read endpoints as well as semi- Administration that some individuals system.17 Sweat also appears to be well automated or automated instrumented may not be able to wear the sweat patch suited for return-to-duty and follow-up testing devices with machine read for the optimal period of time. Skin testing for workplace testing.3,20 endpoints. Drug tests conducted with sensitivity and rash are factors that can these devices utilize competitive only be known after the patch is applied The Added Types of Testing Options binding immunoassays, the same for the first time. and Locations—Major Change scientific principle as the initial tests The Department also knows from Instrumented Initial Test Facility (IITF) conducted in certified laboratories. direct experience that if the patch is The development and commercial applied in a normally visible area of the The Department proposes to include availability of POCT products has body, such as the upper arm, that there IITF options in the Guidelines. An IITF evolved to include both urine and oral could be a stigmatizing effect on the is basically the screening part of a fluid specimens at this time, with more wearer. screening and confirmatory laboratory, specimens likely to be added in the Despite these known limitations, the but established in locations to future. The Department has learned a Department proposes to incorporate this potentially more quickly and great deal from collaboration with the new technology as an optional selection economically meet special local testing National Institute on Drug Abuse, the for Federal agencies because sweat needs. The Department has learned a Administrative Office of the U.S. Courts, testing may be useful in certain great deal from the experience of the the Federal Probation and Parole Office, missions and tasks that only individual NRC, where such urine-based facilities and the Department of Defense (DoD) Federal agencies can identify. were permitted beginning in 1990. Armed Forces drug testing program Unlike urine, head hair, or oral fluid, These IITFs were intended to support office. Collectively, these collaborations the use of a sweat patch detects drug use the periodic large testing needs of and the results of actual product that occurred shortly before the patch is nuclear-fueled electrical power assessments 58 have provided the applied and while the device remains generating facilities, whenever facility experience and knowledge to propose applied to the skin.3,20,37,46 The window maintenance and fuel rod replacements procedures in the Guidelines to more of detection for the sweat patch is for as were needed, at which time hundreds of uniformly assess the on-going long as the patch remains on the skin maintenance workers needed to be performance of these devices in Federal and is a cumulative measure of drug allowed timely access into the secured drug testing applications. ingestion.3,37 areas of the nuclear power plant. Non-instrumented POCT for urine Unlike urine, primarily the parent The numbers and fixed locations of testing have been subjected to drug is found in sweat; however, some IITFs make them more ‘‘like’’ evaluations by investigators drug metabolites may also be laboratories. Presently there are fewer independent of the manufacturers and detected.3,20,36,37,47 Some drugs and than 60 laboratories HHS-certified to found to perform similar to that of the drug metabolites that have been perform workplace urine drug testing instrumented immunoassay tests in detected in sweat are THC,51 for Federal agencies. With the rigorous certified laboratories.55-58 These tests amphetamine, methamphetamine,20,48 certification, performance testing, and were conducted on both spiked and codeine, morphine, 6–AM, inspection requirements proposed for donor specimens with and without drug heroin,40,43,45,47,49,50 PCP,72 and the IITF, it is unlikely that the total analytes. Little difference in the cocaine, benzoylecgonine, ecgonine number of laboratory and laboratory performance of these devices was methylester.20,44,47,52 Investigations to ‘‘like’’ facilities will increase very much, observed between tests conducted by compare the detection of drugs in sweat or even double to 120 in total. Thus, the laboratory technicians and laymen who to other specimens are IITF could be certified in much the had been trained in the proper ongoing.38-41,47,48,51,53,54 same fashion as a laboratory with procedures for conducting and reading Analytes for the regulated drugs inspections and PT, with the focus the tests.55,56 tested in sweat are marijuana (parent exclusively on initial drug and validity Non-instrumented POCTs for oral drug (THC)), cocaine (parent drug or testing. fluid have been characterized by only metabolite benzoylecgonine), PCP The Department proposes that IITFs one group of independent (parent drug), opiates (codeine, should: (1) Be at a permanent location, investigators.59 Their study was morphine, and 6–AM), and (2) meet program forensic standards, (3) performed on spiked oral fluid at amphetamines (amphetamine, participate in open and blind concentrations consistent with the methamphetamine, MDMA, MDA, and proficiency testing, (4) have a rigorous proposed cutoffs. This study found MDEA). quality assurance program, (5) be device variability and difficulty in The amount of sweat excreted is subject to site inspections, (6) use detecting cannabinoids, but suggests the variable for each person and between instrumented immunoassay tests for rapid evolution of the technology individuals and is dependent upon their drugs which meet FDA requirements for should overcome current problems daily activities, emotional state, and commercial distribution, (7) conduct relating to targeted analyte and

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manufacturer’s cutoff and provide an pre-employment, return to duty and Manner of Presentation and the Use of assay consistent with proposed HHS follow-up testing. Plain Language—Major Change ‘‘ cutoffs. The investigators felt that there POCT testing of oral fluid is most Although the order of presentation in is every reason to be optimistic about suited for situations that require quick, the proposed revisions to the Guidelines the future for drug testing using oral negative results such as in emergency/ has been retained, the manner of fluid matrix.’’ 59 Presently, there are no crisis management. It is most suited for presentation has been totally revised. POCT devices that have received FDA This ‘‘improved’’ process has been based clearance for drugs of abuse in hair or reasonable suspicion/cause and post- on the experience and very positive sweat. accident. It may be least suited for POCTs could potentially be employed random testing. Oral fluid is not suited public feedback that other Federal almost anywhere, with hundreds, if not for return to duty, follow-up testing and agencies have had when they used a thousands of testing sites possible. The pre-employment. In order to protect similar process. The goal of the HHS value and utility of the POCT is that it Federal workers from incorrect test process was to revise the manner of provides quick, negative drug results results for marijuana, a second presentation to use ‘‘plain language,’’ and validity test results and has the biological specimen, a urine specimen, and address complex issues by using added benefit of not requiring a fixed will need to be collected at the same simple questions to identify each specific topic. Unfortunately, these facility, expensive test equipment, and time the oral fluid specimen is obtained. highly trained testing personnel; Guidelines are scientifically based and moreover, POCTs could be run in low POCT for Specimen Validity Testing the answers are often complex. Wherever possible, the questions and numbers, infrequently, and at any given Specimen validity POCT devices for location, as needed. These factors make answers have been organized as a group the detection of substitution and the it very difficult, if not impossible to use for a specific specimen, testing option, presence of adulterants have become a laboratory ‘‘like’’ inspection and or related topic. The Department quality assurance process. The use of more widely used in the past three understands that such organization may highly trained laboratory personnel years. Specimen validity POCTs include produce some repetition, for example provides no specific or added value to non-instrumented devices with visually when reading about head hair, oral any oversight process, beyond the actual read endpoints as well as semi- fluid, or sweat, and seeing identical testing of sample POCT devices. automated or automated instrumented information presented for collection Further, the sheer potential number and testing devices with machine read end site, donor identification, or diverse locations of sites where POCT points. Specimen validity tests confidentiality, as repeated text. devices might be used by choice, make conducted with these devices utilize Because this change in format is large-scale, routine, or scheduled on-site colorimetric assays, the same scientific significantly different than the current inspections a logistic and budgeting principle as the initial tests conducted Guidelines, major changes from the nightmare. in certified laboratories. current Guidelines will be noted in the In order to provide an equivalent discussion of each subpart. Non-instrumented specimen validity program of on-going quality assurance POCT for urine testing have been Organization of Draft Guidelines—No for POCT devices, the Department Major Change proposes a certification process under subjected to evaluations by independent which POCT device manufacturers investigators and were able to detect Within the text for the proposed 60-62 would provide tests for evaluation to be abnormal urine specimens. These revisions to the Guidelines, the order of placed on the list of SAMHSA-certified tests were conducted on spiked presentation of topics follows the devices published by the Secretary. This specimens with drug analytes. Results existing Guidelines, with expanded would be followed by periodic from these preliminary studies are details to address the added specimens additional testing as new lots of variable; however, they demonstrate the (head hair, oral fluid, sweat), testing manufactured tests become available as ability of the devices to detect options (IITF and POCT), and related well as PT sample requirements, adulterants and creatinine. This is why issues. This seems to be the most training of POCT testers, and on-going the Department will incorporate the appropriate way to permit those already quality assurance requirements. This is evaluation of the accuracy and familiar with the existing Guidelines to a complex area that will benefit from reliability of specimen validity testing do a detailed comparison with what is public comments now, and from lessons as part of the POCT device evaluation being proposed. For those relatively few learned over time. process. first-time readers of the Guidelines, they may wish to first review the current Advantages of POCTs Urine Specimen Validity Testing Guidelines so as to understand the POCT products could potentially be current proposal. Where there are no On August 21, 2001, HHS published employed almost anywhere. The value changes to specific sections in the a notice in the Federal Register (66 FR and utility of the FDA-cleared and proposed revisions to the Guidelines, 43876), proposing that the Mandatory SAMHSA-certified POCT is that it will that has been stated in the preamble. provide quick, negative drug and Guidelines be revised to include HHS Contractor—No Major Change specimen validity test results. Those specific standards for determining the specimens that test presumptively validity of urine specimens collected by In accordance with current practice, positive for drugs or indicate that Federal agencies under the Federal the HHS contractor performs certain additional specimen validity testing is Workplace Drug Testing Program. The functions on behalf of the Department. necessary would then be referred for Department has issued a final revision These functions include maintaining a confirmatory testing. with comments to the Mandatory laboratory inspection program and a PT POCT testing of urine is most suited Guidelines as they currently exist program that satisfy the requirements for situations that require quick, implementing the urine specimen described in the Guidelines. These negative drug and specimen validity test validity testing requirements. These activities include, but are not limited to, results such as in emergency/crisis requirements have been incorporated in reviewing inspection reports submitted management. It may be least suited for this revision. by inspectors, reviewing PT results

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submitted by laboratories, preparing reasonable suspicion/cause test, recent drug use. Based on the detection inspection and PT result reports, and reconfirmed, rejected for testing, window, oral fluid is most suited for making recommendations to the responsible person, responsible reasonable suspicion/cause and post- Secretary regarding certification, technician, return to duty test, accident. It may be least suited for continued certification, or suspension/ specimen, split specimen, substituted random testing if prior notice (greater revocation of laboratories’ certification. specimen, and standard. Every effort has than 24 hours) is given. Because of the It is important to note that while the been made to define terms such that short detection window, oral fluid is not contractor gathers and evaluates they would apply to each type of suited for return to duty, and follow-up information provided to it by inspectors specimen collected, as appropriate. testing. In order to protect Federal or laboratories, all final decisions Section 1.6 specifies what an agency workers from incorrect test results for regarding laboratory certification, is required to do to protect employee marijuana, a second biological suspension or revocation of certification records. It is the same policy as specimen, a urine specimen, will need status is retained within the described in the current Guidelines to be collected at the same time the oral Department. except it has been amended to include fluid specimen is obtained. In addition, the contractor has records at IITFs, POCT sites, specimen Hair historically collected certain fees from collection sites, and records produced the laboratories for services related to and maintained by medical review Hair is useful for detecting drug use the certification process, specifically for officers. for longer time intervals, i.e., weeks (>7– laboratory application and inspection 10 days) to months. Based on the and PT activities for laboratories Subpart B—Specimens—Major Change detection window, hair is most suited applying to become HHS-certified, and In section 2.1, the Department for pre-employment and random testing. in the process of maintaining HHS- proposes to expand the urine drug The window of detection is much longer certification. All fees that are collected testing program for Federal agencies to than that of urine. Hair may be used for by the contractor are applied to its costs permit testing head hair, oral fluid, and return to duty and follow-up testing under the contract. sweat specimens. The Department depending on the time of last known This same process, which has been wants to make it very clear to agencies drug use. Hair is not suited for used since the inception of the that there is no requirement that they reasonable suspicion/cause and post- laboratory certification program, will use hair, saliva or sweat as part of their accident because it takes 7–10 days for also be used by the HHS contractor to drug testing program, but rather that drug or drug metabolites to appear in collect similar fees from laboratories agencies may use those specimens. If hair. that seek, achieve, and continue HHS- they choose to use these alternative Sweat Patch certification for testing additional types specimens then agencies are required to of specimens (e.g., hair, oral fluid, follow these Guidelines. The window of detection for the sweat), and from IITFs that seek, In section 2.2, in order to guide sweat patch is for as long as the patch achieve, and continue HHS-certification Federal agencies, the Department has remains on the skin and is a cumulative to test hair, oral fluid, sweat, or urine. added to the Guidelines a chart measure of drug ingestion. The sweat The Department also contributes indicating in what circumstances each patch may not be useful for pre- funds to this contract for purposes not specimen can be collected. employment, random, reasonable directly related to laboratory suspicion/cause and post accident drug certification activities, such as Urine testing because it must be worn for days evaluating the technologies and Laboratory based urine testing has after its application. The sweat patch is instruments and providing an traditionally been used for pre- best used for return to duty and follow- assessment of their potential employment, random, reasonable up testing. applicability to workplace drug testing suspicion/cause, post-accident, return- The Department is specifically programs. to-duty, and follow-up testing. requesting public comment on the Drug ingestion for a 3–5 day interval appropriateness of the reasons for Subpart A—Applicability preceding the specimen collection can defining and limiting the selection of Sections 1.1, 1.2, 1.3, and 1.4 contain usually be identified in urine. Based on specimens for the different types of the same policies as described in the the detection window, urine is most testing proposed in this notice. current Guidelines with regard to who suited for random, return to duty and Commenters are requested to submit is covered by the Guidelines, who is follow-up testing. supporting documentation if responsible for the development and Because of the increasingly evident recommending that other reasons for implementation of the Guidelines, how potential that Federal agency workplace testing would be appropriate for some of a Federal agency requests a change from urine-based drug testing has the the types of specimens being collected. these Guidelines, and how these potential for being seriously In section 2.3, the Department Guidelines are revised. compromised by clandestine products proposes to prohibit routinely collecting In section 1.5, where terms are and procedures intended to mask more than one type of specimen from a defined, the Department proposes to current drug use, especially when given donor at the same time except when an add or revise several of the definitions sufficient time to obtain these products, oral fluid specimen is collected. This contained in the Guidelines. These urine drug testing may be least suited restriction is appropriate because it include, for example, new or revised for pre-employment. prevents Federal agencies from definitions for adulterated specimen, expecting an individual to provide certifying scientist, collector, Oral Fluid multiple specimens each time he or she confirmatory validity test, dilute Drug detection times for the regulated is selected for a drug test and then specimen, failed to reconfirm, follow-up analytes in oral fluid range from less attempting to compare results from test, initial validity test, IITF, invalid than one to approximately 24 hours. different types of specimens. It is result, non-negative specimen, oxidizing Drugs may be detected in urine longer expected that different results would be adulterant, POCT facility, post-accident after drug use than in oral fluid. This obtained for the different types of test, pre-employment, random test, makes oral fluid useful in detecting very specimens because the windows of

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detection are different, as explained wishes to routinely test its specimens prevalent in the workplace. The 2002 above. If a problem occurs during the for any drug not included in the National Survey on Drug Use and collection of one type of specimen (e.g., Guidelines must obtain approval from Health (NSDUH)) (available on the shy bladder for a urine specimen, the Department before expanding its Internet at http://www.samhsa.gov/oas/ insufficient specimen available), program. A specimen may be tested for nhsda.htm 63) indicates that the permission can be obtained from the any drug listed in Schedule I or II of the estimated number of people using Federal agency to collect an alternative Controlled Substances Act when there is ecstasy, the generic name for MDMA, specimen. reasonable suspicion/cause to believe within the past year and within the In section 2.4, the Department that a donor may have used a drug not month before the survey was taken, proposes to establish the requirement included in these Guidelines. When exceeded that found for heroin, crack for all specimens to be collected as split reasonable suspicion/cause exists to test cocaine, LSD, and PCP. This is further specimens, and in section 2.5 to for another drug, the Department is supported by Drug Abuse Warning establish a minimum quantity that must proposing that a Federal agency must Network (DAWN) data 64 which finds be collected for each type of specimen. document the possibility that the use of that MDMA was on the list of the top For hair, 100 mg of head hair was the another drug exists, attach the 10 drugs mentioned in emergency room quantity recommended by the hair documentation to the original Federal visits, just below methamphetamine and testing industry. For oral fluid, the drug testing custody and control form was one of the top ten of drugs seized Department is proposing that 2 mL be (Federal CCF), and ensure that the HHS- and sent to Federal, State and municipal collected in a collection tube rather than certified laboratory has the capability to crime laboratories, as noted in the allowing oral fluid to be collected test for the additional drug. The HHS- National Forensic Laboratory directly into a collection device that certified laboratory is expected to Information System (NFLIS) 2002 does not provide an accurate validate the test methods for this Annual Report.65 In 2000, the measurement of the volume of oral fluid additional drug and to use the same prevalence of MDMA found in active collected. This approach allows quality control criteria that are used for duty Army personnel exceeded that of establishing specific cutoffs for oral the other drug analyses described in the methamphetamine.66 Thus, Federal fluid testing. For sweat, since the ‘‘sweat Guidelines. The Department believes agencies may elect to test for additional patch’’ is the only FDA-cleared device this proposed policy is sufficient to drugs including MDMA, under section currently available, the quantity of ensure that this testing for an additional 3.2(a) of the Mandatory Guidelines. sweat collected is determined by the drug would be forensically and The Department is specifically length of time the patch is worn. scientifically supportable. interested in obtaining information on Requiring that the patch be worn at least Section 3.3 restates the policy in the the ability of the various immunoassay 3 days but no more than 7 days ensures current Guidelines that specimens may test kits to detect MDMA, within the that a sufficient amount of sweat is not be used for any unauthorized amphetamine class of drugs. The collected that could possibly contain a purposes. Department is aware that DoD drug tests measurable amount of drugs or drug Sections 3.4, 3.5, 3.6, and 3.7 list the members of the uniformed services for metabolites. For urine, the Department proposed cutoff concentrations for each MDMA using an additional initial test is proposing to eliminate the single type of specimen collected. As focused on that drug. Based on this specimen collection procedure and to previously stated in this preamble, the experience from DoD, if drug testing is require each Federal agency to use the Department is proposing to adopt the proposed at the cutoffs in this split specimen collection procedure. cutoff concentrations that were document, the Department believes that The 45 mL requirement ensures that recommended by the industry working the only sensitive and specific manner each Federal employee is offered the groups. Based on the results from the PT to perform the initial test for same opportunity to have the split testing program, it appears that some methamphetamine, amphetamine, and specimen tested by a second laboratory. industry proposed cutoff concentrations MDMA is to use two separate initial for the alternative specimens are tests, one for methamphetamine and Subpart C—Drug and Validity Tests— currently set at what appears to be amphetamine and a second initial test Major Change approaching a limit of quantitation that for MDMA. Recommendations on using Section 3.1 contains the same policy reflect the analytical capabilities of one a single amphetamine test kit or the that is in the current Guidelines or two laboratories to detect extremely need to use separate test kits are regarding which tests must be low drug concentrations. The requested. performed on a specimen. A Federal Department believes that each The Department periodically reviews agency is required to test each specimen laboratory testing a specific type of the cutoff for all drugs authorized for for marijuana and cocaine, and is specimen for a particular drug must be workplace drug testing and revises those authorized to also test for opiates, able to accurately determine the cutoffs as necessary to maximize the amphetamines, and phencyclidine. The concentration for a drug or drug deterrent effect of the program. As a Department realizes that most Federal metabolite that is less than the cutoff result of this review, the initial test agencies already test for all five drug concentration, as well as concentrations cutoff for marijuana was lowered in classes authorized by the existing equal to or greater than the cutoff. The 1994 and both the initial test and Guidelines, but has not made this a Department is specifically requesting confirmatory test cutoff for opiates was mandatory requirement. The comments on the appropriateness of raised in 1998. These changes were Department will continue to rely on the these cutoff concentrations and the instituted after review of the science individual agencies and departments to ability of laboratories to meet this supporting the change, the technical determine their testing needs above the requirement. capabilities of the certified laboratories minimum. The one new requirement is Since the late 1980’s, a number of and the effect of the change on the that each Federal agency is required to recommendations have been made that deterrent intent of workplace drug ensure that each specimen is tested to additional drugs be considered for testing. determine if it is a valid specimen. inclusion in workplace drug testing. The Department proposes to lower the The policy in section 3.2 remains Over the past decade, MDMA and its cutoff concentration for cocaine and unchanged. Any Federal agency that analogues have become increasingly amphetamine analytes. Reductions in

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initial and confirmatory cutoffs for most cutoff in order to report a specimen Section 3.18 reiterates the criteria to drugs in urine will increase the time positive for methamphetamine. This report a urine specimen as dilute. period in which those drugs will be ‘‘methamphetamine reporting rule’’ is Sections 3.19, 3.20, 3.21, and 3.22 found.67 The proposed lower cutoffs retained because of concerns and reiterate the criteria that will be used to will produce an increase in the number experience that extremely high report a urine specimen as an invalid of urine specimens that are identified as concentrations of pseudoephedrine and/ result and propose the criteria that will containing cocaine metabolites and or ephedrine in a urine specimen can be used to report a head hair, oral fluid, amphetamines.68-70 The cutoff still lead to inappropriate reporting of a and sweat patch, respectively, as an reductions proposed in this revision are methamphetamine positive result when invalid result. The Department believes estimated to identify 10–20 percent in fact there is no methamphetamine these proposed criteria for each type of more urine specimens containing present at a concentration above the specimen collected are appropriate to cocaine metabolites 68,69 and 5–24 cutoff. Additionally, this requirement to ensure that each specimen is a valid percent more urine specimens confirm the presence of amphetamine at specimen. containing amphetamines.70 Data a concentration below the cutoff is provided by currently certified included for reporting a hair, oral fluid, Subpart D—Collectors—Major Change laboratories are consistent with these or sweat patch methamphetamine In section 4.1, the Department is estimates and will increase the deterrent positive result. The confirmatory testing proposing to expand the requirements effect of the program and allow early for amphetamines would be expanded for donor confidentiality for collectors. identification of substance use by to test for MDMA, MDA, and MDEA. Section 4.2 describes what specific individuals. The lowering of these The Department believes that the training requirements individuals are cutoffs should not result in increased certified laboratories have the capability required to have before they may serve claims of passive exposure.71 to accurately test urine specimens using as a collector. The capability of HHS-certified these revised cutoff concentrations. Section 4.3 proposes that another laboratories to respond to these changes Additionally, the revised cutoff person, such as another employee of the has been evaluated. Since the beginning concentrations will increase the organization or company responsible for of this program, laboratories certified by windows of detection for these drugs, providing collection site services, must HHS have exhibited significantly less thereby, increasing the number of provide the training for an individual to quantitative variability when analyzing specimens that may be reported become a collector and specifies the PT samples than applicant laboratories. positive. qualifications for this individual to be a Evaluations of their performance since In sections 3.8, 3.9, and 3.10, the trainer. 1990 have also shown that the Department is proposing which validity In section 4.4, the Department quantitative variability of the certified tests must be conducted on head hair, proposes what an organization must do laboratory population has continued to oral fluids and sweat patches. In section before it allows an individual to serve decrease for all drugs. Evaluations of 3.11, the Department then reiterates performance for the testing of cocaine which validity tests must be conducted as a collector. The Department believes and amphetamines have found that on a urine specimen. The Department these proposed expanded requirements certified laboratories have demonstrated believes these policies are necessary to are necessary to ensure that a collector the precision and accuracy necessary for identify those individuals who are knows the entire collection procedure, the proposed cutoff revisions. Certified attempting to suborn a drug test. There how to interact with the donor, how to laboratories demonstrated their ability are many products marketed on the maintain chain of custody, how to to meet current Guideline requirements Internet and in highly publicized complete the Federal CCF, and how to through the testing of quarterly PT market-focused publications that offer transfer the specimen for testing. samples containing amphetamine, different approaches to suborn drug Subpart E—Collection Sites methamphetamine, and tests. At this time, many products are benzoylecgonine. Documentation of focused on defeating the well- The collection site requirements in their capabilities with method established, mature urine drug testing this subpart are essentially the same as validations has demonstrated the program. The Department believes as those described in the current precision and accuracy of the method alternative specimens become Guidelines, with variations for down to 40 percent of the current increasingly used, attempts to suborn specimen collection that would vary cutoffs. In addition, laboratories have alternative specimen drug tests will around privacy issues required for the been challenged quarterly with PT increase. The Department also collection of a urine specimen, that samples which contained drug recognizes that validity testing proposed would not be required for head hair, concentrations at 40 percent of the for alternative specimens is not as oral fluid, or sweat specimens, based on current cutoff and higher. robust as for urine, but is confident that the experience and input from For urine, the Department proposes to this testing will be refined over time. participating industry-led working lower the initial test cutoff In sections 3.12, 3.13, 3.14, and 3.15, groups for each type of specimen. concentration for cocaine metabolites the Department reiterates the criteria In sections 5.5, 5.6, 5.7, and 5.8, the from 300 ng/mL to 150 ng/mL with a that a laboratory will use to report a Department is proposing specific corresponding decrease of the urine specimen as adulterated and privacy requirements when collecting confirmatory test cutoff concentration proposes the criteria that a laboratory head hair, oral fluid, sweat patch, and from 150 ng/mL to 100 ng/mL. will use to report a head hair, oral fluid, urine specimens, respectively. The Additionally, the initial test cutoff and sweat patch, respectively, as privacy requirements for urine are the concentration for amphetamines would adulterated. same as those described in the current be decreased from 1000 ng/mL to 500 Section 3.16 describes the proposed Guidelines. ng/mL and the confirmatory test cutoff requirements to report an oral fluid For hair, the Department proposes concentration decreased from 500 ng/ specimen as substituted. The that head hair is the only type of hair mL to 250 ng/mL. The Department Department also reiterates the current to collect for a hair sample. The continues to require the presence of requirements with regard to a urine Department believes this is appropriate amphetamine at a concentration below specimen being reported as substituted. because collecting hair only from the

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head is the least invasive area to collect specimen. If the FDA has cleared a extent that Federal agencies lack the a hair sample and affords the donor the collection device, it has been clinical or technical expertise required most privacy. If head hair is not determined that the device does not to fulfill their requirements under this available, the Department believes it is affect the specimen collected. If the FDA proposal, they are free to enter into more appropriate to conduct a drug test has not cleared a collection device, the Economy Act transfers with the using a different specimen rather than Federal agency must only use a Department. attempting to collect hair from another collection device that does not affect the Subpart I—HHS Certification of body site. specimen collected. This requirement Laboratories and IITFs—Major Change For sweat, the Department proposes arises from incidents in the past where that the sweat patch may only be specimen containers themselves, or Section 9.1 reaffirms the goals and applied to the donor’s upper arm, or liners in the lids of specimen containers objectives of the certification program back. The primary site for a sweat patch were found to absorb drugs present in that are the same as those described in is the upper arm; however, applying a a urine specimen. This means that the the current Guidelines. patch to a donor’s chest or back is actual drug concentration in the Section 9.2 describes who has the reasonable if the donor prefers to use specimen was reduced simply by its authority to certify laboratories or IITFs these alternative sites to conceal the fact presence in that particular type of to conduct testing for Federal agencies. that they are wearing a sweat patch. specimen container. Since the This is the same policy as in the current For oral fluid, the Department Department is proposing drug testing Guidelines. proposes that the donor provide an oral using alternative specimens and Section 9.3 describes the process that fluid specimen directly into an technologies, it is reasonable to believe a laboratory or IITF must follow to appropriate container. This approach that new and different specimen become certified to conduct testing for will ensure that a minimum amount of collection devices will be used to collect a Federal agency. The Department oral fluid is collected and can then be Federal employee drug test specimens. believes that including a description of split for on-site testing or sent to a The Department requests specific the certification process will be laboratory for both initial and comments on this requirement. extremely helpful to those laboratories confirmatory testing. or IITFs that are interested in applying For each type of specimen collected, Subpart H—Specimen Collection for certification. It is also important to Procedure—Major Change the collector and the donor are the only understand that a laboratory or IITF individuals present while the specimen In section 8.1, the Department is needs to be certified for each sample is being collected, except when a direct proposing to establish the basic type it wants to test (e.g., hair, oral fluid, observed collection is used to collect a requirements that would apply to sweat, urine) since the testing urine specimen and the observer is collecting any type of specimen. This procedures are different for each. present with the donor. includes a requirement for the collector Section 9.5 describes the to provide identification to the donor if specifications for the PT samples. The Subpart F—Federal Drug Testing the donor asks, explain the basic requirements in this section are the Custody and Control Forms collection procedures to the donor, same as in the current Guidelines. The requirement to collect a Federal request that the donor read the Sections 9.6, 9.7, 9.8, and 9.9 describe agency specimen using an OMB- instructions on the back of the Federal the proposed PT requirements for an approved form is the same as in the CCF, and answer any reasonable and applicant laboratory to conduct testing current Guidelines. An OMB-approved appropriate questions the donor may for each type of specimen. The Federal CCF must be used for each type have regarding the collection procedure. performance testing requirements for of specimen collected. The form for In sections 8.2, 8.3, 8.4, and 8.5, the the urine testing program are the same each type of specimen will be Department is proposing the collection as those in the current Guidelines and developed with the assistance of each procedure to be used to collect each the Department is proposing that similar industry working group and Federal type of specimen. The collection requirements apply to the other types of agencies and approval will be requested procedure for urine is essentially the specimens. from OMB and comment sought from same as that described in the current Sections 9.10, 9.11, 9.12, and 9.13 the public prior to these Guidelines Guidelines. The major change is that a describe the proposed PT requirements being implemented. The Department split specimen collection would be that apply to a certified laboratory for seeks comments on whether it would be required for all specimen collections, each type of specimen. The PT preferable, and practical, to have a including urine. requirements for the urine testing single Federal CCF that could be used In section 8.6, the Department is program are the same as those in the for all the various specimens, rather proposing to require that a Federal current Guidelines and the Department than a multiplicity of forms. The agency conduct an annual inspection of is proposing that similar requirements Department also seeks comment on each collection site that is used for its apply to the other types of specimens. whether it would be useful to add a workplace drug testing program. If Sections 9.14, 9.15, 9.16, and 9.17 requirement that employees and others several Federal agencies are using the describe the proposed PT requirements could not alter the Federal CCF in any same collection site, then only one for an applicant IITF to become certified way, e.g., could not write comments on Federal agency is required to conduct an for each type of specimen tested. The it. inspection. The Department believes Department is including requirements this requirement will ensure that for an IITF in this section because of the Subpart G—Collection Device collectors and collection sites satisfy all similarity of an IITF to the part of a Section 7.1 describes what is the collection requirements in these laboratory that performs initial testing. considered to be the collection device Guidelines for each type of specimen Thus, the same requirements will apply that is used to collect each type of collected. For the Department to directly to an IITF as to that portion of a specimen. carry out this responsibility for a laboratory which performs initial In section 7.2, the Department Federal agency, the Department would testing. describes the proposed policy on which incur substantial financial and Sections 9.18, 9.19, 9.20, and 9.21 devices may be used to collect a administrative costs. However, to the describe the proposed PT requirements

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for an HHS-certified IITF to remain notice regarding these actions. It is to challenge each laboratory with 20 certified to test each type of specimen. possible for a laboratory or IITF to lose percent blind samples to determine if a Section 9.22 describes the inspection certification for one sample type while laboratory is making either requirements for an applicant laboratory retaining certification to test another administrative or technical errors in the or IITF to become certified. As noted type. This is because the kinds of testing testing of specimens. above, the Department is including procedures used to test one type of In section 10.3, the Department is requirements for an IITF in this section sample can be very different from proposing how a blind sample is to be because of the similarity of an IITF to procedures and equipment used to test submitted to a laboratory. This section the part of a laboratory that performs another sample type. provides more detail on how to initial testing. Thus, the same Section 9.31 restates the policy in the complete the Federal CCF and ensure requirements will apply to an IITF as to current Guidelines that a list of HHS- proper submission of the blind samples that portion of a laboratory which certified laboratories and IITFs will be to the laboratory or IITF. performs initial testing. published monthly in the Federal In section 10.4, the Department is Section 9.23 describes the inspection Register. The list will also indicate the proposing the procedure to be used to requirements for an HHS-certified types of specimens for which each investigate errors associated with blind laboratory or IITF to remain certified. laboratory or IITF is certified to test. samples. This proposed procedure The Department proposes to change the provides direction and detail on how to requirement that a certified laboratory Subpart J—Blind Samples Submitted by evaluate information on what led to an or IITF be inspected by a team of three an Agency inconsistent result. inspectors to a requirement that a Section 10.1 continues to require the Subpart K—Laboratory—Major Change certified laboratory or IITF be inspected supplier of a blind sample to ensure that by at least one inspector. The number of the contents have been validated and This subpart has basically the same inspectors used for maintenance are stable until the expiration date. requirements that are contained in the inspections would vary depending on Additionally, the Department proposes current Guidelines with the following the size of the laboratory. The that drug positive blind samples must changes. Department believes that one trained have concentrations sufficiently above Section 11.4 describes a new policy inspector may be sufficient to conduct the cutoff concentrations used to give a for when the responsible person (RP) a thorough inspection of extremely positive result. This requirement leaves a certified laboratory. As stated in small laboratories. ensures that sample degradation will the current Guidelines, the RP assumes In section 9.24, the Department is not affect the blind sample and the professional, organizational, proposing the requirements for an laboratory will always report a positive educational, and administrative individual to serve as an inspector for result. The Department also proposes responsibility for the laboratory’s drug the HHS-certification program. The that blind samples for the urine testing testing facility. The Department believes proposed requirements have been used program contain adulterants or satisfy it is essential to ensure that drug testing for the past several years and are being substitution criteria to challenge a is routinely performed under the incorporated into the Guidelines. An laboratory’s capability to identify direction and supervision of an individual may serve as an inspector for adulterated or substituted specimens. individual with such qualifications. In the Secretary if he or she has experience The specific requirement for urine this section, the Department proposes and an educational background similar specimens is based on the donor privacy requirements to ensure this takes place. to that required for either the issue associated with providing a urine Additionally, the Secretary will begin responsible person or the certifying specimen, where direct observation is the process of suspension or revocation scientist as described in subpart K for a not used, and the potential exists for an in accordance with the Guidelines if the laboratory, or as a responsible adulterant to be added to the collected RP leaves and no RP is approved within technician as described in subpart M, specimen before it is turned over to the 180 days. This requirement is essential has read and thoroughly understands collector. There are no similar donor to protect the interests of the United the policies and requirements contained privacy issues associated with the States and its employees to ensure that in these Guidelines and in other collection of head hair, oral fluid, or an HHS-certified laboratory has an guidance consistent with these sweat. individual that can fully attest to the Guidelines provided by the Secretary, The Department seeks comment on forensic and scientific supportability of submits a resume and documentation of whether the proposed reduction of the the laboratory’s testing program. qualifications to HHS, attends approved blind sample rate to one percent will be Section 11.9 requires that a laboratory training, and submits an acceptable sufficient to achieve the objectives of must be HHS-certified separately for inspection report and performs sending blind samples to laboratories each type of specimen that it wants to acceptably as a trainee inspector on an especially with respect to the newer test for a Federal agency. The separate inspection. specimens with which laboratories, certification is necessary because of the Section 9.25 describes what happens collectors and others are less familiar at differences among urine, head hair, oral when an applicant laboratory or IITF this time. fluid, and sweat specimens in all phases fails to satisfy the PT requirements or In section 10.2, the Department is of collection, testing, reporting and on- the inspection requirements. The proposing to reduce the 20 percent going inspection and performance consequences are the same as currently requirement for blind samples, for each testing. An HHS certification for a apply to laboratories in the current type of specimen to be tested (i.e., urine, laboratory performing urine tests would Guidelines. head hair, oral fluid, or sweat) to 3 provide no quality assurance about that Sections 9.27, 9.28, and 9.29 apply percent during the initial 90-day period laboratory performing testing on other the same requirements that are in the of a new Federal agency program specimens. current Guidelines regarding the factors because the 20 percent requirement is In section 11.15, the Department used to revoke the certification of a excessive and redundant. Since the proposes to allow the use of additional laboratory or an IITF, directing a beginning of the urine testing program, analytical procedures for the laboratory or IITF to immediately there has never been any evidence to confirmatory drug tests. For some of the suspend testing, and the issuance of a suggest that each Federal agency needs types of specimens, the confirmatory

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drug tests may be performed by LC/MS, In section 11.33, the Department has including establishing a new GC/MS/MS, and LC/MS/MS in addition revised the summary report that a organization to oversee compliance, to to the GC/MS that has been traditionally laboratory must provide to a Federal do inspections, and to maintain the PT used to test urine specimens. The agency to include validity test results. requirements. As we did so, however, Department believes these additional Additionally, the frequency of the report logistical challenges developed that confirmatory methods are scientifically has been significantly reduced from could not be readily overcome. valid, based on on-going reviews of the monthly to semiannually. The Instead, the Department is adopting a scientific and forensic literature, and the Department believes that a semiannual principle that if a Federal agency assessment of a DTAB working group report is sufficient to track the chooses to use POCTs, then it accepts that has studied these newer effectiveness of an agency’s program. some of the same responsibilities for instruments and technologies. These In section 11.34, the Department is ensuring compliance within their additional confirmatory methods are the proposing a more detailed description of agency as the Department currently methods and instruments that have been what information a donor is entitled to maintains for the laboratory-based identified by the industry-led working receive upon request through the MRO Federal drug testing program. The groups that must be used to successfully and the Federal agency. The Department specifics of these requirements are detect and report the cutoff believes access to the proposed addressed below. concentrations proposed in subpart C. information is appropriate and Section 12.2 establishes criteria for In sections 11.18, 11.19, 11.20, and sufficient. the Secretary to certify a POCT for use 11.21, the Department is proposing to Section 11.35 describes the in the Federal drug testing program. The use the same analytical and quality information a certified laboratory must device must be FDA-cleared for the control requirements for conducting provide to its private sector clients purposes of detecting drugs of abuse validity tests for each type of specimen when it is using procedures to test its and it must be determined by the collected. The Department has specimens that are different than those Secretary that it effectively determines intentionally proposed to use the same used to test Federal agency specimens. the presence or absence of drugs and the validity of a specimen, either as an requirements for each type of specimen Subpart L—Point of Collection Test integral function of the POCT device or based on the established requirements (POCT)—Major Change as a set of compatible devices or for a urine specimen; however, Employees of Federal agencies are in procedures. The second standard is information may become available some cases located in remote areas of applied because FDA’s premarket during the public comment period to the country if they are serving with the notification clearance process ensures suggest that the requirements for each Department of Interior, or overseas if that a device is substantially equivalent type of specimen should be different. they are serving with the Department of to a legally marketed device, but does In sections 11.22, 11.23, 11.24, and State. They are often in locations with not ensure that the device will satisfy 11.25, the Department reiterates the few employees as is often the case when minimum performance requirements specific analytical requirements to they are serving on American Indian that are necessary for its use in the conduct each validity test for a urine reservations or in embassies in small Federal drug testing program. specimen and proposes the specific foreign countries. It is often unrealistic Section 12.4 identifies the two types analytical requirements to conduct each to expect that a drug testing program in of POCTs currently available, both of validity test for head hair, oral fluid, such places would operate in the same which could be considered for and sweat patch specimen collected. fashion as one that serves employees in Secretarial certification: non- The Department believes these the Washington, DC, area. It is in these instrumented devices where end results requirements will ensure that the circumstances and in cases where it is are determined visually or instrumented validity test results reported by a critical to receive an immediate test devices where results are obtained by laboratory are scientifically supportable. result that POCT tests play an important instrumental evaluation. Sections 11.26, 11.27, 11.28, and role. Section 12.5 provides manufacturers a 11.29 describe in detail how a certified Yet a POCT offers a particular list of what they must provide the laboratory is required to report test challenge to the Federal drug testing Secretary in order to have their device results to MROs for each type of program because the device that is used or devices included on the list of specimen collected. These sections to produce a negative test result is really SAMHSA-certified devices. Among the include the details of urine specimen equivalent to a laboratory test to which requirements, the manufacturer must validity testing, and also propose that the normal laboratory procedures and provide 100 POCT devices and related laboratories report drug and/or requirements cannot readily apply. testing procedures so that the Secretary metabolite concentrations to the MROs Thus, while the sections of the may analyze the devices for on all specimens reported as positive. Guidelines related to specimens, effectiveness when testing for drugs and The Department understands that the collection procedures, collections sites, specimen validity. data exist, and can be reported chain of custody, drug and validity Section 12.7 indicates that to remain electronically as part of the normal testing and others do apply, it is on the list of SAMHSA-certified workflow, and no longer pose a barrier necessary to establish requirements devices, the manufacturer must agree to or significant burden to laboratories. In particular to POCTs. In addition, it provide to the Secretary any design fact, the Department believes that presents logistical problems on how to changes or alterations that have been requiring MROs to request ensure compliance with the made to the device so that the Secretary concentrations by exception would requirements of these Guidelines and may determine if additional testing is create an extra burden to the MRO and thus ensure the integrity of the program necessary to ensure effectiveness and 50 the laboratory, and slow the reporting of when any one agency choosing to use POCTs as outlined so that the Secretary the final test result by the MRO to the POCT may have many remote sites all can ensure the continued quality of the Federal agency. The Department over the United States and in many device. encourages public comment on the cases all over the world. Section 12.8 is critical to the use of appropriateness of this proposed To address the logistical problem, the POCTs within the Federal drug testing requirement. Department considered several options program. This section lays out the

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responsibilities of the Federal agency in for approval but in so doing must information is available to the donor, order for it to use POCT. provide a statement to the Secretary and what type of relationship is If a Federal agency chooses to use describing what has been done to prohibited between a manufacturer of a POCT, then it must use only POCTs that address the problem that led to the POCT device or a POCT site operation are on the list of SAMHSA-certified device’s removal. and a Medical Review Officer. Also, devices, ensure that only trained testers To further ensure the integrity of the what type of relationship can exist are used and provide them with a system, the Guidelines require that one between a manufacturer of a POCT standard operating procedures manual, of every 10 negative samples must be device or a POCT site operation and an ensure that the requirements of the sent to an HHS-certified laboratory for HHS-certified laboratory is discussed. regulation are fulfilled, accomplish the confirmation. The results of this process inspection of the POCT test sites, will be given to the Federal agency. Subpart M—Instrumented Initial Test accomplish proficiency testing, To date, POCT tests have only been Facility (IITF)—Major Change maintain records on the trainers as well developed for oral fluid and urine. If, in In this subpart, the Department as inspections, investigate failures, the future, POCTs are developed for hair proposes the requirements for a new make available all Federal agency and/or sweat and the POCTs are cleared type of facility. It is being called an records for the POCT-related activities by the FDA, the Department will review instrumented initial test facility (IITF). for periodic inspection by the Secretary, the devices to evaluate, among other An IITF is essentially a laboratory that and other responsibilities. For the things, whether they use the cutoff only conducts initial tests for drugs and Department to directly carry out this identified by these Guidelines, what validity tests. The facility is at a responsibility for the Federal agency, their performance is around that cutoff, permanent location and uses the Department would incur substantial and whether the observed lot to lot instrumented initial tests. An IITF must administrative and financial costs. variability is appropriate for the satisfy most of the same requirements as However, to the extent that Federal program’s needs. Section 12.11 if it were the section of a laboratory that agencies lack the clinical or technical identifies the responsibility of the performs only initial drug and validity expertise required to fulfill their Secretary to inspect a Federal agency testing and was located in an HHS- requirements under this proposal, they using POCT. These responsibilities certified laboratory. An IITF is certified are free to enter into Economy Act include, but are not limited to, under the same provisions as a transfers within the Department. conducting a semiannual inspection of laboratory as indicated above in subpart With regard to performance testing, each Federal agency that uses POCT. I. One significant difference is that the the Federal agency will provide sets of These inspections will include a review IITF is managed by a responsible HHS-contractor prepared PT samples of the Federal agency’s records, technician (RT) whose qualifications are periodically to the POCT testing sites to standard operating procedure manual, described in section 13.6, and differ ensure reliability and integrity of the POCT tester training records, POCT slightly from those of a responsible system. The results of the proficiency device quarterly PT results, and POCT person as required for laboratories. tests will be forwarded to the Federal quality assurance data maintained by An IITF may be certified to test head agency. Where errors have occurred the each POCT tester and site. hair, oral fluid, sweat, and/or urine Federal agency must act to investigate Section 12.16 presents the specimens as stated in section 13.2. It is the cause of the error and determine requirements that a POCT tester must also important to understand that an whether it was an error in procedure or meet. It should be kept in mind that the IITF needs to be certified for each a failure of the device. If the error was individual is not just a collector but in sample type it wants to test (e.g., hair, a procedural one, the Federal agency some capacity functions as a technician oral fluid, sweat, urine), since the must assess the reason for error and take in so far as the individual must perform testing procedures are different for each. corrective action to ensure compliance the POCT test, determine specimen An IITF must test specimens using the with the Guidelines in the future. validity, perform analysis on periodic same drug cutoff concentrations as used If the error is with the device, the PT challenges, interpret and document for the initial tests conducted by the Federal agency must immediately notify test results, and when required, forward HHS-certified laboratories as stated in the Secretary who may suspend the use the specimens with non-negative test section 13.3. The Department is of the device within the agency. The results to an HHS-certified laboratory including these requirements for an IITF Department, after considering the for confirmatory testing. Thus the in this section because of the similarity information, may suspend the use of the training and experience requirements of an IITF to the part of a laboratory that device throughout the Federal drug reflect this additional responsibility. performs initial testing. Thus, the same testing program by informing the To ensure that the process is carried requirements will apply to an IITF as agencies through the Federal Register out appropriately the Department has in that portion of laboratory. and notifying the manufacturer of the section 12.18 outlined how a POCT Section 13.8 describes a new policy problem. The manufacturer then has 30 should be conducted step by step. These for when the responsible technician days to provide information for the procedures should be part of the Federal (RT) leaves a certified laboratory. The Secretary’s consideration at which time agency standard operating procedure RT assumes professional, the Secretary will decide what action manual. Again the process pays special organizational, educational, and needs to be taken. Additionally, the attention to the integrity of the test administrative responsibility for the Secretary will notify the FDA of any results and the specimen, chain of IITF drug testing. The Department error with a device so that the FDA can custody, collection procedures, believes it is essential to ensure that evaluate whether an action under the recordkeeping, and reporting. drug testing is routinely performed Food, Drug, and Cosmetic Act is The Guidelines for a POCT mirror the under the direction and supervision of necessary. provision in subparts K and M in that an individual with such qualifications. The Secretary is also authorized to they discuss how a negative result In this section, the Department proposes remove a device from the list of should be reported as well as what must requirements to ensure this takes place. SAMHSA-certified devices in the happen to a specimen with non-negative Additionally, the Secretary will begin absence of a suspension. A results. The Guidelines further discuss the process of suspension or revocation manufacturer may resubmit the device reporting requirements, what in accordance with the Guidelines if the

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RT leaves and no RT is approved within the Federal Register of those entities oral fluid or urine specimen when the 180 days. This requirement is essential and boards that have been approved. primary specimen was reported to protect the interests of the United In section 14.2, the Department is substituted. It should be noted that a States and its employees to ensure that proposing the specific training head hair or sweat patch sample cannot an HHS-certified IITF has an individual requirements before a physician may be reported as substituted. that can fully attest to the forensic and serve as an MRO for Federal agencies. In sections 15.10, 15.11, 15.12, and scientific supportability of the IITF This training should occur before the 15.13, the Department is proposing the testing program. physician takes the required actions an MRO must take after The Department proposes in section examination. receiving the split specimen result from 13.16 that an IITF be required to retain In section 14.3, the Department the second laboratory for each type of records for a period of 2 years, which is proposes that an individual who works specimen. the same period required for under the direct supervision of an MRO Section 15.14 describes how an MRO laboratories. may conduct the review and report of a reports the split specimen result to a The Department proposes in section negative result. However, the MRO must Federal agency. It is the same procedure 13.17 that an IITF submit a semiannual review 5 percent of the negative results that is used to report the result on the report on the numbers of specimens reported by staff to ensure that the staff primary specimen. In section 15.15, the Department tested for Federal agencies, again the are properly performing the review proposes to require that the certified same requirement as for laboratories. process. laboratory retain a split specimen for the In section 13.18, the Department In sections 14.4, 14.5, 14.6, and 14.7, the Department proposes the procedure same length of time that the primary proposes what information would be specimen is retained. available to a donor from an IITF, again an MRO must follow to review the the same requirement as for laboratories. results reported for each type of Subpart P—Criteria for Rejecting a In sections 13.19 and 13.20, the specimen. For specimens reported as Specimen for Testing—Major Change invalid by the laboratory, the Department proposes to prohibit and The Department proposes to include permit the same types of relationships Department proposes to allow the MRO to direct the agency to have another this subpart to describe how between the IITF and the MRO as laboratories, IITFs, or MROs are to between the laboratory and the MRO. specimen collected. The Department requests comments on whether the same handle errors or discrepancies that arise The Department proposes in section type of specimen or one of the other with the use of the Federal CCF. They 13.21 that an IITF report a negative types of specimens should be collected were not contained in the current result to an MRO within 3 working days when this occurs. Guidelines; however, most of the of receipt of the specimen and that Section 14.8 describes how the donor policies were previously established in negative results may be reported may request the testing of a split guidance documents. The Department electronically. Reporting a negative specimen. believes there is a need to establish result electronically is the same Section 14.9 describes how the MRO specific guidance on how a laboratory, requirement as for a specimen that is reports a primary specimen test result to IITF, or MRO must handle determined to be negative on an initial a Federal agency. discrepancies. Since the forms used to test conducted by a certified laboratory. Section 14.10 describes the transfer the custody of a specimen from In section 13.22, the Department relationship that is prohibited between the collector to the POCT tester have not proposes how a specimen that is an MRO and a laboratory, POCT tester, yet been developed, the Department presumptive drug positive, adulterated, or IITF. cannot propose a specific list of possible substituted, or invalid must be shipped errors or discrepancies that would need to an HHS-certified laboratory for Subpart O—Split Specimen Tests— to be corrected and included in this confirmatory testing. Major Change section. The Department, however, fully Subpart N—Medical Review Officer Section 15.1 amends the current expects to include this list when the (MRO)—Major Change Guidelines by giving the donor the right final Guidelines are developed. to have a split specimen tested when a In section 16.1, the Department In Section 14.1, the Department primary specimen was reported proposes those discrepancies that are establishes who may serve as an MRO, substituted or adulterated. This section considered to be fatal flaws, that is, the including the requirement that the also proposes to give a Federal agency laboratory or IITF must not test a individual successfully complete an the option to have a split specimen specimen when one of the fatal flaws examination administered by a tested as part of a legal or administrative occurs. The Department is specifically nationally recognized entity that proceeding to defend an original requesting comments on any additional certifies MROs or subspecialty board for positive, adulterated, or substituted fatal flaws that may apply to the physicians performing a review of result if a donor chooses not have the collection of head hair, sweat, and oral Federal employee drug test results, split specimen tested. fluid or fatal flaws that may occur when which has been approved by the In section 15.2, the Department is the collector transfers the specimen to a Secretary. This section also establishes proposing the policy on how a second POCT tester (if the POCT tester is not the requirements for nationally laboratory tests each type of split the collector). recognized entities that seek approval specimen when the primary specimen Section 16.2 identifies only two errors by the Secretary to certify MROs or for was reported positive for a drug(s). that the Department believes must be subspecialty boards for physicians In sections 15.3, 15.4, 15.5, and 15.6, corrected (recovered) by obtaining a performing a review of Federal the Department is proposing the policies memorandum for record (MFR) from the employee drug test results to submit on how a second laboratory will test collector before the laboratory or IITF their qualifications and sample each type of split specimen when the can report a test result to the MRO. The examination. Based on an annual primary specimen was reported Department is specifically requesting objective review of the qualifications adulterated. Similarly, sections 15.7 and comments on any additional correctable and content of the examination, the 15.8 describe the proposed policies on errors that may apply to the collection Secretary shall annually publish a list in how a second laboratory will test a split of head hair, sweat, and oral fluid or

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correctable errors that may occur when of laboratories and simply expanding Again with regard to oral fluids, the the collector transfers the specimen to a them to include IITFs. preamble mentions a possibility of an POCT tester (if the POCT tester is not individual having a ‘‘dry mouth.’’ The Electronic Technology Applications the collector). Department would appreciate any Section 16.3 describes the types of The Department is aware that there comments on whether the Department omissions and discrepancies that has been a great deal of discussion in should adopt a specific procedure for occasionally occur on the Federal CCF. recent years concerning the application ‘‘dry mouth’’ as it has for ‘‘shy bladder’’ When an omission or discrepancy of electronic technology to the operation under urine. occurs that is considered to be of drug testing programs. Electronic With regard to proper cleansing of the insignificant, the laboratory or IITF may signatures on documents, electronic skin prior to the application of a sweat proceed with testing the specimen and storage and transmission of records, and patch, the Department is requesting reporting a result without taking any appropriate security precautions for comment on the proposal that the skin action to recover or correct the error, confidential information are all issues of area be washed with soap and cool omission, or discrepancy. Although substantial interest as applied to Federal water or with a disposable towelette each of these errors, omissions, or testing programs. The Department seeks followed by a thorough cleaning of the discrepancies are considered comment on the extent to which this skin area where the patches will be insignificant, the Department believes discussion should be reflected in the worn with alcohol wipes. that requiring collectors to be trained new version of the guidelines, and on The Department defines in section 1.5 ‘‘ and certified will significantly reduce whether specific provisions concerning both confirmatory validity test’’ and ‘‘ the occurrence of such errors, electronic technology applications to confirmatory drug test.’’ The omissions, or discrepancies. However, Federal drug testing programs should be confirmatory validity test means putting a different aliquot of the specimen when a collector, laboratory, or IITF included. through the same analytical method. A makes an error, omission, or Impact of These Guidelines on confirmatory drug test involves a second discrepancy more than once a month, Government Regulated Industries analytical procedure performed on a the Department is proposing that the The Department is well aware that different aliquot. The Department MRO contacts the collector, laboratory, these proposed changes to the requests comments on whether the or IITF and directs the collector or Guidelines may impact the DOT and utilization of these procedures is laboratory to take immediate action to NRC regulated industries depending on sufficient. prevent the recurrence of the error, their decisions to incorporate the final In section 2.2, the Department is omission, or discrepancy. The Guidelines into their programs under proposing to limit the use of alternative Department is requesting specific their own authorities. specimens for only those reasons listed. comments on the proposal to have the The Department is requesting comments Issues of Special Interest MRO track these types of problems as on the appropriateness of the reasons well as identifying other insignificant The Department requests public listed and supporting documentation if omissions or discrepancies that have not comment on all aspects of this notice. recommending changes. been included for the Federal CCF. However, the Department is providing In section 2.5, the Department Public comments are requested for the following list of issues or areas for requires that a sweat patch should be possible omissions or discrepancies that which specific comments are requested. worn at least three days and no more may occur when completing a Federal In the preamble discussion on than 7 days. While the Department CCF to document collecting head hair, alternative specimen issues, there are believes that this is an adequate time sweat, and oral fluid specimens or conflicting studies that hair color affects period, the Department seeks comments insignificant types of discrepancies that the amount of drug deposited into the and additional science on whether the may occur when the collector transfers hair. In other words, some studies permitted time period should be longer the specimen to a POCT tester (if the purport that a drug user with dark hair or shorter, and what time frame should POCT tester is not the collector). is more likely to test positive because a be used in specific circumstances. In section 16.4, the Department drug is more likely to be deposited in Sections 3.4, 3.5, 3.6, and 3.7 list the proposes to identify those discrepancies black hair as compared to blond hair proposed cutoff concentrations for each that must be corrected before an MRO while other studies refute these type of specimen collected. The can report a test to the Federal agency. findings. The Department is requesting Department is specifically requesting If one of these errors occurs and it is not specific comments on this hair color comments on the appropriateness of corrected by obtaining an MFR from the bias issue as it applies to the testing of these proposed cutoffs and the changes collector, IITF, or laboratory, the MRO individuals in a workplace in the cutoffs for urine. Additionally, is required to cancel the test. The environment. the Department is interested in Department is requesting specific With regard to testing oral fluid obtaining information on the ability of comments on any other errors that must specimens for marijuana, there is the various immunoassay test kits to be corrected before the MRO can report scientific evidence that the parent detect MDMA within the amphetamine a test result or discrepancies that may marijuana compound (THC) in oral fluid class of drugs. occur and must be corrected when the is not from plasma, but is residual THC In section 7.2, the Department is collector transfers the specimen to a present either from smoking a marijuana requiring a Federal agency to only use POCT tester (if the POCT tester is not cigarette or from oral contamination. To a collection device that does not affect the collector). ensure that a THC result on an oral fluid the specimen collected. The Department specimen is from active exposure, the Subpart Q—Laboratory/IITF is requesting specific comments on this Department is proposing to always Suspension/Revocation Procedures requirement. collect a urine specimen with an oral In section 11.13, the Department In this subpart, the Department is fluid specimen that would be available establishes criteria for laboratories retaining the procedures that were if the oral fluid specimen was positive validating an initial drug test. These described in the current Guidelines to for THC. The Department is requesting criteria are significantly different from suspend or revoke the HHS-certification comments on this proposed policy. those that are currently in the

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Guidelines and thus the Department 7. Rollins D.E., Wilkins D.G., Gygi S.P., Sensitivity, specificity, and efficiency in specifically seeks comments on this Slawson M.H., and Nagasawa P.R. (1997). detecting opiates in oral fluid with the  change. Testing for drugs of abuse in hair— Cozart Opiate Microplate EIA and GC–MS In sections 11.18, 11.19, 11.20, and Experimental observations and indications following controlled codeine administration. 11.21, the Department is proposing to for future research. Forensic Sci Review, J Anal Toxicol, 27:402. 9:24. 24. Kim I., Barnes A.J., Schepers R., use the same analytical and quality 8. Reid R.W., O’Connor F.L., and Crayton Moolchan E.T., Wilson L., Cooper G., Reid C., control requirements for conducting J.W. (1994). The in vitro differential binding Hand C., Huestis M.A. (2003). Sensitivity and validity tests for each type of specimen of benzoylecgonine to pigmented human hair specificity of the Cozart microplate EIA collected. The Department is requesting samples. J Toxicol Clin Toxicol, 32:405. cocaine oral fluid at proposed screening and specific comments on this proposed 9. Henderson G.L., Harkley M.R., Zhou C., confirmation cutoffs. Clin Chem, 49:9. policy. Jones R.T., and Jacob P. (1998). Incorporation 25. Dams R., Huestis M.A., Lambert W.E., Sections 11.26, 11.27, 11.28, and of isotopically labeled cocaine into human and Murphy C.M. (2003). Matrix effect in bio- 11.29 propose to allow a laboratory to hair: race as a factor. J Anal Toxicol, 22:156. analysis of illicit drugs with LC–MS/ 10. Borges C.R., Wilkins D.G., and Rollins MS:influence of ionization type, sample report quantitative values for non- D.E. (2001). Amphetamine and N- preparation and biofluid. J Am Soc Mass negative specimens rather than waiting acetylamphetamine incorporation into hair: Spectrom, 14:1290. for the MRO to request the information. an investigation of the potential role of drug 26. Niedbala R.S., Kardos K.W., Fritch D.F., The Department is requesting comments basicity in hair color bias. J Anal Toxicol, Kardos S., Fries T., and Waga J. (2001). on this change in reporting test results. 25:221. Detection of marijuana use by oral fluid and In sections 14.4, 14.5, 14.6, and 14.7, 11. Hoffman B.H. (1999). Analysis of race urine analysis following single-dose the Department is proposing to allow effects on drug-test results. J Occup Environ administration of smoked and oral marijuana. the MRO to direct the agency to have Med, 41:612. J Anal Toxicol, 25:289. another specimen collected when an 12. Kelly R.C., Mieczkowshi T., Sweeney 27. Cone E.J. (1997). New Developments in invalid test result is reported. The S.A., and Bourland J.A. (2000). Hair analysis Biological Measures of Drug Prevalence. In: for drugs of abuse. Hair color and race L. Harrison and A. Hughes (Eds.) The Department is requesting comments on differentials or systematic differences in drug Validity of Self-Reporting Drug Use: whether the same type of specimen or preferences? Forensic Sci Int, 107:63. Improving the Accuracy of Survey Estimates. another type of specimen should be 13. Mieczkowshi T. and Newel R. (2000). NIDA Res Monogr 167:108. collected. Statistical examination of hair color as a 28. Schramm W., Smith R.H., Craig P.A., In sections 16.1, 16.2, and 16.3, the potential biasing factor in hair analysis. and Kidwell D.A. (1992). Drugs of abuse in Department is requesting specific Forensic Sci Int, 107:13. saliva: a review. J Anal Toxicol, 16:1. comments on any additional fatal flaws, 14. Slawson M.H., Wilkins D.G., and 29. Ho¨ld K.M., de Boer, D., Zuidema, J., correctable errors, omissions or Rollins D.E. (1998). The incorporation of and Maes. R.A.A. (1995). Saliva as an discrepancies that may apply to the drug into hair: relationship of hair color and analytical tool in toxicology, Int J Drug melanin concentration to phencyclidine Testing, 1:1. collection of head hair, sweat, and oral incorporation. J Anal Toxicol, 22:406. 30. Jenkins A.J., Oyler J.M., and Cone E.J. fluid or that may occur when the 15. Uhl M. (1997). Determination of drugs (1995). Comparison of heroin and cocaine collector transfers a specimen to a point in hair using GC/MS/MS. Forensic Sci Int, concentrations in saliva with concentrations of collection test (POCT) tester. 84:281. in blood and plasma. J Anal Toxicol, 19:359. Additionally, the Department is 16. Pichini S., Pacifici R., Altieri I., 31. Hawks R.L. (1982). The constituents of requesting comments on the Pellegrini M., and Zuccaro P. (1999). cannabis and the disposition and metabolism requirement that MROs track these Determination of opiates and cocaine in hair of cannabinoids. In Hawks RL (Ed): The types of problems. as trimethylsilyl derivatives using gas Analysis of Cannabinoids in Biological In section 16.4, the Department is chromatography—tandem mass Fluids, NIDA Research Monograph Series 42; requesting specific comment on any spectrometry. J Anal Toxicol, 23:343. U.S. Government Printing Office; 17. Cone E.J. (2001). Legal, workplace, and Washington, DC; p. 125. other errors that must be corrected treatment drug testing with alternative 32. Samyn N., Verstraete A., van Haeren C., before an MRO can report a test. biological matrices on a global scale. Forensic and Kintz P. (1999). Analysis of drugs of Sci Int, 121:7. abuse in saliva, Forensic Sci Rev, 11:1. References 18. Yacoubian G.S., Wish E.D., and Perez 33. Mucklow J.C., Bending M.R., Kahn 1. Nakahara Y. (1999). Hair analysis for D.M. (2001). A comparison of saliva testing G.C., Dollery C.T. (1978). Drug concentration abused and therapeutic drugs. J Chromatogr to urinalysis in an arrestee population. J of in saliva. Clin Pharmacol Ther, 5:563. B Biomed Sci Appl, 733:161. Psychoactive Drugs, 33:289. 34. Cone E.J. (1993). Saliva testing for 2. Rollins D.E., Wilkins D.G., Krueger G.G., 19. Wish E.D. and Yacoubian G.S. (2002). drugs of abuse. Ann NY Acad Sci, 694:91. Augsburger M.P., Mizuno A., O’Neal C., A comparison of the Intercept oral 35. Wolff F., Farrell M., Marsden J., Borges C.R., and Slawson M.H. (2003). The specimen collection device to laboratory Monteiro M.G., Ali R., Welch S., and Strang effect of hair color on the incorporation of urinalysis among Baltimore city arrestees. J. (1999). A review of biological indicators of codeine into human hair. J Anal Toxicol, Federal Probation, 66:27. illicit drug use, practical considerations and 27:545. 20. Caplan Y.H. and Goldberger B.A. clinical usefulness. Addiction, 94:1279. 3. Huestis M.A. and Cone E.J. (1998). (2001). Alternative specimens for workplace 36. Skopp G. and Potsch L. (1999). Alternative Testing Matrices, in Drug Abuse drug testing. J Anal Toxicol, 25:396. Perspiration versus saliva-basic aspects Handbook, edited by S.B. Karch, CRC Press, 21. Cone E.J., Presley L., Lehrer M., Seiter concerning their use in roadside drug testing. Boca Raton, FL. W., Smith M., Kardos K.W., Fritch D., Int J Legal Med, 112:213. 4. Kidwell D.A. and Blank D.L. (1996). Salamone S., Niedbala R.S. (2002). Oral fluid 37. Cone E.J. and Preston K.L. (1999). Drug Environmental Exposure—The Stumbling testing for drugs of abuse: positive prevalence testing in support of drug-abuse treatment Block of Hair Testing, in Drug Testing in rates by Intercept TM immunoassay screening programs. AACC Therapeutic Drug Hair, edited by P. Kintz, CRC Press, Boca and GC–MS–MS confirmation and suggested Monitoring And Toxicology Education Raton, FL. cutoff concentrations. J Anal Toxicol, 26:541. Article 175:184. 5. Cone E.J. and Joseph R.E. (1996). The 22. Kidwell D.A., Holland J.C., and 38. Crouch D.J., Cook R.F., Trudeau J.V., Potential for Bias in Hair Testing for Drugs Athanaselis S. (1998). Testing for drugs of Dove D.C., Robinson J.J., Webster H.L., and of Abuse, in Drug Testing in Hair, edited by abuse in saliva and sweat. J Chromatogr, Fatah A.A. (2001). The detection of drugs of P. Kintz, CRC Press, Boca Raton, FL. 713:111. abuse in liquid perspiration. Technical Note, 6. Henderson G.L. (1993). Mechanisms of 23. Barnes A.J, Kim I., Schepers R., J Anal Toxicol, 1:625. drug incorporation into hair. Forensic Sci Int, Moolchan E.T., Wilson L., Cooper G., Reid C., 39. Kidwell D.A., Kidwell J.D., Shinohara 63:19. Hand C., and Huestis M.A. (2003). F., Harper C., Roarty K., Bernadt K.,

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McCaulley R.A., and Smith F.P. (2003). 56. Kadehjian L.J. (2001). Performance of 72. Fay J.F., and Niedbala, S. (1995). Sweat Comparison of daily urine, sweat, and skin five non-instrumented urine drug-testing eluate analysis for phencyclidine by STC swabs among cocaine users. Forensic Sci Int, devices with challenging near-cutoff Diagnostics PCP Micro-Plate EIA and GC/MS. 133:63. specimens. J Anal Toxicol, 25:670. Presentation Society of Forensic 40. Kintz P., Brenneisen R., Brundeli P., 57. Peace M.R, Tarnai L.D., Poklis A. Toxicologists. and Mangin P. (1997). Sweat testing for (2002). Performance evaluation of four on- heroin and metabolites in a heroin site drug-testing devices for detection of Executive Order 12866: Economic maintenance program. Cl Chem, 43:736. drugs of abuse in urine. J Anal Toxicol, Impact 41. Levisky J.A., Bowerman D.L., Jenkins 24:589. In accordance with Executive Order 58. SAMHSA study entitled ‘‘On-site W.W., Johnson D.G., Levisky J.S., and Karch 12866, the agency has submitted the S.B. (2001). Comparison of urine to sweat Testing: An Evaluation of Non-Instrumented patch results in court ordered testing, Drug Test Devices,’’ dated January 29, 1999, Guidelines for review by the Office of Forensic Sci Int, 122:65. available on the Internet at http:// Management and Budget. However, 42. Skopp G., Potsch L., Eser H.P., and www.workplace.samhsa.gov/ResourceCenter/ because the Mandatory Guidelines will Moller M.R. (1996). Preliminary practical r409.htm. not have an annual impact of $100 findings on drug monitoring by a 59. Walsh J.M., Flegel R., Crouch D.J., million or more, and will not have a transcutaneous collection device. J Forensic Cangianelli L., Baudys J. (2003). An material adverse effect on the economy, Sci, 41:933. evaluation of rapid point-of-collection oral fluid drug-testing devices. J Anal Toxicol, productivity, competition, jobs, the 43. Huestis M.A., Cone E.J., Wong C.J., environment, public health or safety, or Umbricht A., and Preston K.L. (2000) 27:429. Monitoring opiate use in substance abuse 60. Peace M.R. and Tarnai L.D. (2002). State, local or tribal governments, they treatment patients with sweat and urine drug Performance evaluation of three on-site are not subject to the detailed analysis testing. J Anal Toxicol, 24:509. adulterant detection devices for urine requirements of section 6(a)(3)(C) of 44. Warren M., Fortner N., Fogerson R., specimens. J Anal Toxicol, 26:464. Executive Order 12866. and Sutliff J. (1996). Detection of cocaine and 61. Wong B., Nguyen P., Wong R., and Tse its metabolites using the PharmChekTM sweat H. (2002). Adulterants: Its detection and Paperwork Reduction Act of 1995 patch. Presentation Society of Forensic effects on urine drug screens. Abstract: Society of Forensic Toxicologists 2002 These proposed revised Mandatory Toxicologists. Guidelines contain information 45. Fogerson R., Schoendorfer D., Fay J., Meeting. 62. Wong R. (2002). The effect of collections which are subject to review and Spiehler V. (1997). Qualitative detection by the Office of Management and of opiates in sweat by EIA and GC-MS. J Anal adulterants on urine screen for drugs of abuse: Detection by an on-site dipstick Toxicol, 21:451. Budget (OMB) under the Paperwork device. Am Clin Lab, 21:37. 46. Spiehler V., Fay J., Fogerson R., Reduction Act of 1995 (the PRA) (44 63. Report entitled ‘‘2002 National Survey Schoendorfer D., and Niedbala R.S. (1996). U.S.C. 3507(d)). The title, description on Drug Use and Health (National Household Enzyme immunoassay validation for and respondent description of the Survey on Drug Abuse),’’ available on the qualitative detection of cocaine in sweat. Cl Internet at http://www.samhsa.gov/oas/ information collections are shown in the Chem, 42:34. nhsda.htm. following paragraphs with an estimate 47. Preston L.P., Huestis M.A., Wong C.J., 64. Report entitled ‘‘Emergency Department of the annual reporting, disclosure and Umbricht A., and Goldberger B.A. (1999). Trends From DAWN: Final Estimates 1995– recordkeeping burden. Included in the Monitoring cocaine use in substance-abuse- 2002,’’ available on the Internet at http:// estimate is the time for reviewing treatment patients by sweat and urine testing. dawninfo.samhsa.gov. instructions, searching existing data J Anal Toxicol, 23:313. 65. Report entitled ‘‘Year 2002 Annual 48. Suzuki S., Inoue T., Hori H., and sources, gathering and maintaining the Report National Forensic Laboratory data needed, and completing and Inayama S. (1989). Analysis of Information System (NFLIS).’’ methamphetamine in hair, nail, sweat, and 66. Bruins M.R, Okano C.K., Lyons T.P., reviewing the collection of information. saliva by mass fragmentography. J Anal and Lukey B.J. (2002). Drug-positive rates for Title: Proposed Revisions to the Toxicol, 13:176. the army from fiscal years 1991 to 2000 and Mandatory Guidelines for Federal 49. Kintz P., Tracqui A., Mangin P., and for the National Guard from fiscal years 1997 Workplace Drug Testing Programs. Edel Y. (1996). Sweat testing in opioid users to 2000. Mil Med, 167:379. Description: The Mandatory with a sweat patch. J Anal Toxicol, 20 393. 67. Jones R.T. (1997). Pharmacokinetics of Guidelines establish the scientific and 50. Fay J., Fogerson R., Schoendorfer D., cocaine considerations when assessing Niedbala R.S., and Spiehler V. (1996). technical guidelines for Federal drug cocaine use by urinalysis. NIDA Research testing programs and establish standards Detection of methamphetamine in sweat by Monograph, 175:221. EIA and GC-MS. J Anal Toxicol, 20:398. 68. Wingert W.W. (1997). Lowering cutoffs for certification of laboratories engaged 51. Kintz P., Cirimele V., and Ludes B. for initial and confirmation testing for in drug testing for Federal agencies (2000). Detection of cannabis in oral fluid cocaine and marijuana: large scale study of under authority of Public Law 100–71, (saliva) and forehead wipes (sweat) from effects on the rates of drug-positive results. 5 U.S.C. 7301 note, and Executive Order impaired drivers. J Anal Toxicol, 24:557. Clin Chem, 43:100. 12564. Federal drug testing programs 52. Fogerson R. and Sutliff J. (1995). 69. Cone E.J., Sampson-Cone A.H., Darwin test applicants to sensitive positions, Testing for cocaine and opiate use with the W.D., Huestis M.A., and Oyler, J.M. (2003). individuals involved in accidents, PharmChekTM Sweat Patch, presentation Urine testing for cocaine abuse: Metabolic Society of Forensic Toxicologists. individuals for cause, and random and excretion patterns following different testing of persons in sensitive positions. 53. Sampyn N., DeBoeck G., and Verstrate routes of administration and methods for A.G. (2002). The use of oral fluid and sweat detection of false negative results. J Anal The program has depended on urine wipes for the detection of drugs of abuse in Toxicol, 27:386. testing since 1988; the reporting, drivers. J Forensic Sci, 47:1380. 70. Oyler J.M., Cone E.J., Joseph R.E. Jr, recordkeeping and disclosure 54. Samyn N., De Boeck G., Wood M., Moolchan E.T., and Huestis M.A. (2002). requirements associated with urine Lamaaras C.T.J., DeWaard S., Brookhuis K.A., Duration of detectable methamphetamine testing are approved under OMB control Verstraete A.G., and Riedel W.J. (2002). and amphetamine excretion in urine after number 0930–0158. Since 1988 several Plasma, oral fluid and sweat wipe ecstasy controlled oral administration of products have appeared on the market concentrations in controlled and real life methamphetamine to humans. Clin Chem, making it easier for individuals to conditions. Forensic Sci Int, 128:90. 48:1703. 55. Crouch D.J., Hersch R.K., Cook R.F., 71. Cone A.J., Yousefnejad D., Hillsgrove adulterate the urine sample. The Frank J.F., and Walsh J.M. (2002). A field M.J., Holicky B., and Darwin W.D. (1995). proposed changes to the Guidelines evaluation of five on-site drug-testing Passive inhalation of cocaine. J Anal Toxicol, address this concern. Also, scientific devices. J Anal Toxicol, 26:493. 19:399. advances in the use of head hair, sweat,

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and oral fluid in detecting drugs have In an effort to shorten the time for The burden estimates in the tables made it possible for these specimens to negative results to be reported to the below are based on the following be used in Federal programs with the Federal agency, the proposed changes number of respondents: 38,000 donors same level of confidence that has been also establish criteria for an IITF that who apply for employment in testing applied to the use of urine. The will only perform initial tests and not designated positions, 100 collectors, 50 proposed changes establish when these confirmatory tests, and POCTs or on-site urine testing laboratories, 10 hair testing alternative specimens may be used, the testing kits, as well as POCT testers. laboratories,10 oral fluid testing procedures that must be used in Description of Respondents: laboratories, 2 sweat testing laboratories, collecting a sample, and the certification Individuals or households; Businesses 25 IITFs, 30 POCT manufacturers, 50 process for approving a laboratory to or other for-profit; Not-for-profit POCT testers, and 100 MROs. test these alternative specimens. institutions.

ESTIMATE OF ANNUAL REPORTING BURDEN

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

9.3(c), 9.4(a) and Laboratory or IITF 9.4(a) and (b) required to submit (b) application for certification ...... 50 1 3 150 9.24(b)(3) Materials to submit to become an HHS inspector ...... 200 1 2 400 11.4(a) Laboratory submits qualifications of alternate RP to HHS ...... 50 1 2 100 11.4(d) Laboratory submit information to HHS on new RP ...... 25 1 2 50 11.32(a) Specifications for laboratory semi-annual statistical re- port of test results to each Federal agency ...... 72 5 0.5 180 12.5 Specifies what a POCT manufacturer must submit to HHS to be approved ...... 30 1 1 30 12.7(a) Specifies what a POCT manufacturer must submit to HHS to remain on approved list ...... 30 1 0.5 15 12.14(b) Requirements for POCT manufacturer statement of action to overcome problems that cause a device to be removed from the approved list ...... 1 1 3 3 13.8(a) Information an IITF must submit to HHS for an RT ...... 25 1 2 50 13.8(d) Information an IITF must submit to HHS for a new RT candidate ...... 25 1 2 50 13.17(a) Specifies contents of IITF semi-annual statistical re- port to Federal agencies served ...... 25 5 0.5 63 13.22(d) Specifies how IITF reports test results for specimen that is presumptive drug positive, adulterated, sub- stituted or invalid ...... 25 100 0.05 (3 min) 125 15.14 Specifies that MRO must report all verified split speci- men test results to the Federal agency ...... 100 5 0.05 (3 min) 25 17.1(b); 17.5(a) Specifies content of request for informal review of sus- pension/proposed revocation of certification ...... 1 1 3 3 17.4 Specifies information appellant provides in first written submission when laboratory or IITF suspension/rev- ocation is proposed ...... 1 1 0.5 0.5 17.6 Requires appellant to notify reviewing official of resolu- tion status at end of abeyance period ...... 1 1 0.5 0.5 17.7(a) Specifies contents of appellant submission for review 1 1 50 50 17.9(a) Specifies content of appellant request for expedited review of suspension or proposed revocation ...... 1 1 3 3 17.9(c) Specifies contents of review file and briefs ...... 1 1 50 50

Total ...... 456 ...... 1,358

The following reporting requirements 8.5(a)(8) and (14)); collector annotates calculated a separate reporting burden are also in the proposed Guidelines, but the Federal CCF when a sample is a for these requirements because they are have not been addressed in the above blind sample (section 10.3(a)); and MRO included in the burden hours estimated reporting burden table: collector must notifies the Federal agency and HHS for collectors to complete Federal CCFs report any unusual donor behavior or when an error occurs on a blind sample and for MROs to report results to appearance on the Federal CCF (sections (section 10.4(c)). SAMHSA has not Federal agencies.

ESTIMATE OF ANNUAL DISCLOSURE BURDEN

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

4.4(c) Collector is given name and phone of Federal agency point of contact ...... 100 1 0.05 (3 min) 5 11.33(b) Information on drug test that laboratory must provide to donor through MRo ...... 50 10 3 1,500

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ESTIMATE OF ANNUAL DISCLOSURE BURDEN—Continued

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

12.24 Information related to drug test that POCT tester must provide to donor through MRO ...... 50 10 1 500 13.18 Information related to drug test that IITF must provide to donor through MRO ...... 25 10 2 500 14.8(b) MRO must inform donor of right to request split speci- men test when non-negative result is reported ...... 100 5 3 1,500

Total ...... 325 ...... 4,005

The following disclosure laboratory is not testing their specimen are not being tested under the requirements are also included in the under the Guidelines (section 11.35). Guidelines, this is also a standard proposed Guidelines, but have not been SAMHSA believes having the collector business practice and not considered an addressed in the above disclosure explain the collection procedure to the additional burden because it ensures burden table: the collector must explain donor and to answer any questions is a that a private sector client is not being the basic collection procedure to the standard business practice and not a mislead into believing that its donor and answer any questions disclosure burden. With regard to specimens are being tested under the (section 8.1(b) and (d)); and a laboratory requiring a laboratory to inform a Guidelines. must tell private sector clients when the private sector client that its specimens

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

8.2–8.5 Collector completes Federal CCF for each type of specimen collected ...... 100 380 0.07 (4 min) 2,660 11.8(a) Laboratory completes Federal CCF upon receipt of specimen and before reporting result ...... 50 760 0.05 (3 min) 1,900 12.18(c) POCT tester completes Federal CCF for primary spec- imen and documents chain of custody ...... 50 100 0.05 (3 min) 250 13.12(a) IITF completes Federal CCF upon receipt of specimen and before reporting result ...... 25 1520 0.05 (3 min) 1,900 14.3(a)(4) MRO completes the Federal CCF before reporting the result ...... 100 380 0.05 (3 min) 1,900 15.1(b) Donor must request the split to be tested in writing ..... 300 1 0.05 (3 min) 15

Total ...... 625 ...... 8,625

The proposed Guidelines contain a procedure. These recordkeeping supportability of the test results. number of recordkeeping requirements requirements are an integral part of the Therefore, they are considered to be that SAMHSA considers not to be an collection procedure and are essential to standard business practice and are not additional recordkeeping burden. In documenting the chain of custody for considered a burden for this analysis. subpart D, a trainer is required to the specimens collected. The burden for This same opinion applies to the document the training of an individual these entries is included in the recordkeeping requirements for POCT to be a collector (section 4.3(a)) and that recordkeeping burden estimated to testers in section 12.23, for IITFs in the documentation be maintained in the complete the Federal CCF and is, section 13.16(a), and for MROs in collector’s training file (section 4.4(b)). therefore, not considered an additional section 14.3(a)(5). SAMHSA believes this training recordkeeping burden. Subparts K and Thus the total annual response documentation is common practice and M describe a number of recordkeeping burden associated with the testing of is not considered an additional burden. requirements for laboratories and these alternative specimens by the new In subpart F, if a collector uses an instrumented initial test facilities (IITFs) laboratories and Instrumented Initial incorrect form to collect a Federal associated with their testing procedures, Test Facilities (IITFs) and Point of agency specimen, the collector is maintaining chain of custody, and Collection Test sites is estimated to be required to provide a statement (section keeping records (i.e., sections 11.1(a), 13,888 hours (that is, the sum of the 6.2(b)) explaining why an incorrect form 11.1(d), 11.2(b), 11.2(c), 11.2(d), 11.7(c), total hours from the above tables). This was used to document collecting the 11.8(b), 11.8(c), 11.8(e), 11.13(b), is in addition to the 1,788,089 hours specimen. SAMHSA believes this is an 11.14(c), 11.16, 11.17(c), 11.17(d), currently approved by OMB under extremely infrequent occurrence and 11.31(a), 13.4(a), 13.4(d), 13.5, 13.7(b), control number 0930–0158 for urine does not create a significant additional 13.7(c), 13.7(d), 13.10(c), 13.11(c), testing under the existing Mandatory recordkeeping burden. Subpart H 13.12(b), 13.12(c), 13.12(e), 13.13, and Guidelines. (sections 8.5(a)(8) and (14)) requires 13.16(a)). These recordkeeping As required by section 3507(d) of the collectors to enter any information on requirements are necessary for any PRA, the Secretary has submitted a copy the Federal CCF of any unusual findings laboratory or IITF to conduct forensic of these proposed revised Mandatory during the urine specimen collection drug testing and to ensure the scientific Guidelines to OMB for its review.

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Comments on the information collection collected? 5.6 What are the privacy requirements requirements are specifically solicited 2.3 Can more than one type of specimen be when collecting an oral fluid specimen? in order to: (1) Evaluate whether the collected at the same time from the same 5.7 What are the privacy requirements proposed collection of information is donor? when collecting a sweat patch sample? 2.4 How is each type of specimen to be 5.8 What are the privacy requirements necessary for the proper performance of collected? when collecting a urine specimen? HHS’s functions, including whether the 2.5 What is the minimum quantity of information will have practical utility; specimen to be collected? Subpart F—Federal Drug Testing Custody (2) evaluate the accuracy of HHS’s and Control Forms Subpart C—Drug and Validity Tests estimate of the burden of the proposed 6.1 What form is used for the collection of collection of information, including the 3.1 Which tests must be performed on a a specimen? validity of the methodology and specimen? 6.2 What happens if a Federal CCF is not 3.2 Can a specimen be tested for additional available or is not used? assumptions used; (3) enhance the drugs? quality, utility, and clarity of the 3.3 May any of the specimens be used for Subpart G—Collection Device information to be collected; and (4) other purposes? 7.1 What is a collection device? minimize the burden of the collection of 3.4 What are the cutoff concentrations for 7.2 Which collection devices may be used? hair samples? information on those who are to Subpart H—Specimen Collection Procedure respond, including through the use of 3.5 What are the cutoff concentrations for appropriate automated, electronic, oral fluid specimens? 8.1 What must the collector do before starting a specimen collection mechanical, or other technological 3.6 What are the cutoff concentrations for sweat patch samples? procedure? collection techniques or other forms of 3.7 What are the cutoff concentrations for 8.2 What procedure is used to collect a information technology. urine specimens? head hair sample? OMB is required to make a decision 3.8 What validity tests must be performed 8.3 What procedure is used to collect an concerning the collection of information on a hair sample? oral fluid specimen? contained in these proposed Guidelines 3.9 What validity tests must be performed 8.4 What procedure is used to collect a between 30 and 60 days after on an oral fluid specimen? sweat patch sample? publication of this document in the 3.10 What validity tests must be performed 8.5 What procedure is used to collect a urine specimen? Federal Register. Therefore, a comment on a sweat patch sample? 3.11 What validity tests must be performed 8.6 What are the responsibilities of a to OMB is best assured of having its full on a urine specimen? Federal agency that uses a collection effect if OMB receives it within 30 days 3.12 What criteria are used to report a hair site? of publication. This does not affect the sample as adulterated? Subpart I—HHS Certification of Laboratories deadline for the public to comment to 3.13 What criteria are used to report an oral and IITFs HHS on the proposed Guidelines. fluid specimen as adulterated? Organizations and individuals 3.14 What criteria are used to report a sweat 9.1 What are the goals and objectives of desiring to submit comments on the patch sample as adulterated? HHS-certification? 3.15 What criteria are used to report a urine 9.2 Who has the authority to certify information collection requirements laboratories and IITFs that want to test should direct them to the Office of specimen as adulterated? 3.16 What criteria are used to report an oral specimens for Federal agencies? Information and Regulatory Affairs, fluid specimen as substituted? 9.3 What is the process for a laboratory or OMB. (address above). 3.17 What criteria are used to report a urine IITF to become HHS-certified and to maintain that certification? Charles G. Curie, specimen as substituted? 3.18 What criteria are used to report a urine 9.4 How does a laboratory or IITF apply to Administrator, SAMHSA. specimen as dilute? become HHS-certified? Dated: April 2, 2004. 3.19 What criteria are used to report a hair 9.5 What are the qualitative and Tommy G. Thompson, sample as an invalid result? quantitative specifications of a performance test (PT) sample? Secretary. 3.20 What criteria are used to report an oral 9.6 What are the PT requirements for an For the reasons set forth in the fluid specimen as an invalid result? 3.21 What criteria are used to report a sweat applicant laboratory to conduct hair preamble, the Department proposes to patch sample as an invalid result? testing? revise the Mandatory Guidelines for 3.22 What criteria are used to report a urine 9.7 What are the PT requirements for an Federal Workplace Drug Testing specimen as an invalid result? applicant laboratory to conduct oral fluid Programs to read as follows: testing? Subpart D—Collectors 9.8 What are the PT requirements for an Mandatory Guidelines for Federal 4.1 Who may collect a specimen? applicant laboratory to conduct sweat Workplace Drug Testing Programs 4.2 What are the requirements to be a patch testing? trained collector for a Federal agency? 9.9 What are the PT requirements for an Subpart A—Applicability 4.3 How is a collector’s training applicant laboratory to conduct urine Sec. documented? specimen testing? 1.1 Whom do these Guidelines cover? 4.4 What must an organization do before a 9.10 What are the PT requirements for an 1.2 Who is responsible for developing and collector is permitted to collect HHS-certified laboratory to conduct hair implementing these Guidelines? specimens for a Federal agency? testing? 1.3 How does a Federal agency request a 9.11 What are the PT requirements for an change from these Guidelines? Subpart E—Collection Sites HHS-certified laboratory to conduct oral 1.4 How are these Guidelines revised? 5.1 Where can a collection for a drug test fluid testing? 1.5 What do the terms used in these take place? 9.12 What are the PT requirements for an Guidelines mean? 5.2 What are the requirements for a HHS-certified laboratory to conduct 1.6 What is an agency required to do to collection site? sweat patch testing? protect employee records? 5.3 How long must collection site records 9.13 What are the PT requirements for an be stored? HHS-certified laboratory to conduct Subpart B—Specimens 5.4 How does the collector ensure the urine testing? 2.1 What types of specimens may be security of a specimen at the collection 9.14 What are the PT requirements for an collected? site? applicant IITF to conduct hair testing? 2.2 Under what circumstances can the 5.5 What are the privacy requirements 9.15 What are the PT requirements for an different types of specimens be when collecting a hair sample? applicant IITF to conduct oral fluid

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testing? 11.7 What security measures must an HHS- 11.35 What information must an HHS- 9.16 What are the PT requirements for an certified laboratory maintain? certified laboratory provide to its private applicant IITF to conduct sweat patch 11.8 What are the internal laboratory chain sector clients? testing? of custody requirements for a specimen Subpart L—Point of Collection Test (POCT) 9.17 What are the PT requirements for an or an aliquot? applicant IITF to conduct urine testing? 11.9 Which type of specimens may an HHS- 12.1 What is the goal of this subpart? 9.18 What are the PT requirements for an certified laboratory test? 12.2 What POCT devices may be used in a HHS-certified IITF to conduct hair 11.10 What test(s) does an HHS-certified Federal Workplace Drug Testing testing? laboratory conduct on a specimen Program? 9.19 What are the PT requirements for an received after a POCT? 12.3 What is the rationale for the additional HHS-certified IITF to conduct oral fluid 11.11 What test(s) does a HHS-certified requirements to use POCT devices testing? laboratory conduct on a specimen besides FDA clearance? 9.20 What are the PT requirements for an received from an IITF? 12.4 What types of POCT devices are there? HHS-certified IITF to conduct sweat 11.12 What are the requirements for an 12.5 What must a POCT device patch testing? initial drug test? manufacturer submit to the Secretary to 9.21 What are the PT requirements for an 11.13 What must an HHS-certified have its POCT device initially included HHS-certified IITF to conduct urine laboratory do to validate an initial drug on the list of SAMHSA-certified POCTs? testing? test? 12.6 What criteria will the Secretary use to 9.22 What are the inspection requirements 11.14 What are the batch quality control place a POCT device on the list of for an applicant laboratory or IITF? requirements when conducting an initial SAMHSA-certified POCTs? 9.23 What are the maintenance inspection drug test? 12.7 What is required for a FDA cleared requirements for an HHS-certified 11.15 What are the requirements for a POCT device to continue on the list of laboratory or IITF? confirmatory drug test? SAMHSA-certified devices? 9.24 Who can inspect an HHS-certified 11.16 What must an HHS-certified 12.8 What are the responsibilities of a laboratory or IITF and when may the laboratory do to validate a confirmatory Federal agency that wishes to conduct inspection be conducted? drug test method? POCT? 9.25 What happens if an applicant 11.17 What are the quality control 12.9 What are the qualitative and laboratory or IITF does not satisfy the requirements when conducting a quantitative specifications for PT minimum requirements for either the PT confirmatory drug test? samples that are used to evaluate test program or the inspection program? 11.18 What are the analytical and quality devices submitted by manufacturers or 9.26 What happens if an HHS-certified control requirements for conducting for a Federal agency to evaluate a POCT laboratory or IITF does not satisfy the validity tests on hair samples? site and tester? minimum requirements for either the PT 11.19 What are the analytical and quality 12.10 What are the inspection requirements program or the inspection program? control requirements for conducting for a Federal agency wishing to use a 9.27 What factors are considered in validity tests on oral fluid specimens? POCT? determining whether revocation of a 11.20 What are the analytical and quality 12.11 What is the responsibility of the laboratory’s or IITF’s certification is control requirements for conducting Secretary to inspect a Federal agency necessary? validity tests on sweat patch samples? using a POCT? 9.28 What factors are considered in 11.21 What are the analytical and quality 12.12 What is a failure for the purposes of determining whether to suspend a control requirements for conducting the POCT? laboratory or IITF? validity tests on urine specimens? 12.13 What is the responsibility of the 9.29 How does the Secretary notify a 11.22 What are the requirements for Secretary when a failure is reported? laboratory or IITF that action is being conducting each validity test on a hair 12.14 How can a manufacturer apply to taken against the laboratory or IITF? sample? have a device reinstated on the list of 9.30 May a laboratory or IITF that had its 11.23 What are the requirements for SAMHSA-certified devices? certification revoked be recertified to test conducting each validity test on an oral 12.15 What types of specimens may be Federal agency specimens? fluid specimen? tested using a POCT? 9.31 Where is the list of HHS-certified 11.24 What are the requirements for 12.16 What are the requirements to be a laboratories and IITFs published? conducting each validity test on a sweat POCT tester? patch sample? 12.17 What happens if a POCT site or tester Subpart J—Blind Samples Submitted by an 11.25 What are the requirements for does not satisfy the minimum technical Agency conducting each validity test on a urine requirements? 10.1 What are the requirements for Federal specimen? 12.18 What are the requirements for agencies to submit blind samples to 11.26 What are the requirements for an conducting a POCT? HHS-certified laboratories or IITFs? HHS-certified laboratory to report a hair 12.19 What are the quality control 10.2 What are the requirements for a blind test result? requirements when conducting POCTs? sample? 11.27 What are the requirements for an 12.20 What action must be taken when a 10.3 How is a blind sample submitted to the HHS-certified laboratory to report an oral POCT quality control sample fails? HHS-certified laboratory or IITF? fluid test result? 12.21 What does a POCT tester do with a 10.4 What happens if an inconsistent result 11.28 What are the requirements for an specimen after conducting a POCT? is reported on a blind sample? HHS-certified laboratory to report a 12.22 How is a POCT negative result sweat patch test result? reported? Subpart K—Laboratory 11.29 What are the requirements for an 12.23 How long must records generated at 11.1 What is a standard operating HHS-certified laboratory to report a urine the POCT site be retained? procedure manual? test result? 12.24 What POCT information is available 11.2 What are the responsibilities of the 11.30 How long must an HHS-certified to the donor? responsible person (RP)? laboratory retain a specimen? 12.25 What statistical summary report must 11.3 What scientific qualifications in 11.31 How long must an HHS-certified a Federal agency provide to the analytical toxicology must the RP have? laboratory retain records? Secretary? 11.4 What happens when the RP is absent 11.32 What statistical summary report must 12.26 What type of relationship is or leaves an HHS-certified laboratory? an HHS-certified laboratory provide? prohibited between a manufacturer of a 11.5 What qualifications must an individual 11.33 What information is available to the POCT device or a POCT site operation have to certify a result reported by an donor? and an MRO? HHS-certified laboratory? 11.34 What type of relationship is 12.27 What type of relationship can exist 11.6 What qualifications and training must prohibited between an HHS-certified between a manufacturer of a POCT other laboratory personnel have? laboratory and an MRO? device or a POCT site operation and an

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HHS-certified laboratory? 14.10 What type of relationship is Subpart Q—Laboratory/IITF Suspension/ prohibited between an MRO and an Revocation Procedures Subpart M—Instrumented Initial Test HHS-certified laboratory, POCT tester, or Facility (IITF) 17.1 When may an HHS-certified laboratory HHS-certified IITF? or IITF be suspended? 13.1 What is an HHS-certified IITF? Subpart O—Split Specimen Tests 17.2 What definitions are used for this 13.2 Which types of specimens may be subpart? tested at an HHS-certified IITF? 15.1 When may a split specimen be tested? 17.3 Are there any limitations on issues 13.3 What cutoff concentrations are used by 15.2 How does an HHS-certified laboratory subject to review? an HHS-certified IITF for the drug tests? test a split hair, oral fluid, sweat, or 17.4 Who represents the parties? 13.4 What must be included in the HHS- urine specimen when the primary 17.5 When must a request for informal certified IITFs standard operating specimen was reported positive? review be submitted? procedure manual? 15.3 How does an HHS-certified laboratory 17.6 What is an abeyance agreement? 13.5 What must the HHS-certified IITF do test a split hair sample for adulterants 17.7 What procedure is used to prepare the to validate an initial drug test? when the primary sample was reported review file and written argument? 13.6 What qualifications must the adulterated? 17.8 When is there an opportunity for oral responsible technician (RT) have? 15.4 How does an HHS-certified laboratory presentation? 13.7 What are the responsibilities of an RT? test a split oral fluid specimen for 17.9 Are there expedited procedures for 13.8 What happens when an RT is absent or adulterants when the primary specimen review of immediate suspension? leaves an HHS-certified IITF? was reported adulterated? 17.10 Are any types of communications 13.9 What qualifications must an individual prohibited? have to certify a test result reported by 15.5 How does an HHS-certified laboratory test a split sweat patch sample for 17.11 How are communications transmitted an HHS-certified IITF? by a reviewing official? 13.10 What qualifications and training must adulterants when the primary sample was reported adulterated? 17.12 What is the authority and other HHS-certified IITF personnel have? responsibilities of the reviewing official? 13.11 What security measures must an 15.6 How does an HHS-certified laboratory test a split urine specimen for 17.13 What administrative records are HHS-certified IITF maintain? maintained? 13.12 What are the internal IITF chain of adulterants when the primary specimen was reported adulterated? 17.14 What are the requirements for a custody requirements for a specimen or written decision? 15.7 How does an HHS-certified laboratory an aliquot? 17.15 Is there a review of the final test a split oral fluid specimen for 13.13 What are the batch quality control administrative action? requirements when conducting the substitution when the primary specimen initial tests for drugs? was reported substituted? Authority: E.O. 12564 and sec. 503 of Pub. 13.14 What are the analytical and quality 15.8 How does an HHS-certified laboratory L. 110–71. control requirements for conducting test a split urine specimen for Subpart A—Applicability initial validity tests? substitution when the primary specimen 13.15 What action is taken after an HHS- was reported substituted? Section 1.1 Whom Do These certified IITF tests a specimen? 15.9 Who receives the split specimen Guidelines Cover? 13.16 How long must an HHS-certified IITF result? retain records? 15.10 What action(s) does the MRO take (a) These Guidelines apply to: 13.17 What statistical summary report must after receiving the split hair sample (1) Executive Agencies as defined in an HHS-certified IITF provide? result from the second laboratory? 5 U.S.C. 105; 13.18 What IITF information is available to 15.11 What action(s) does the MRO take (2) The Uniformed Services, as the donor? after receiving the split oral fluid defined in 5 U.S.C. 2101(3) (but 13.19 What type of relationship is specimen result from the second excluding the Armed Forces as defined prohibited between an HHS-certified laboratory? in 5 U.S.C. 2101(2)); IITF and an MRO? 15.12 What action(s) does the MRO take (3) Any other employing unit or 13.20 What type of relationship can exist after receiving the split sweat patch authority of the Federal Government between an HHS-certified IITF and an sample result from the second except the United States Postal Service, HHS-certified laboratory? laboratory? 13.21 How does an HHS-certified IITF the Postal Rate Commission, and 15.13 What action(s) does the MRO take report a negative test result? employing units or authorities in the after receiving the split urine specimen 13.22 How does an HHS-certified IITF Judicial and Legislative Branches; and result from the second laboratory? handle a specimen that is presumptive (4) The Intelligence Community, as drug positive, adulterated, substituted, or 15.14 How does an MRO report a split defined by E.O. 12333, are subject to invalid? specimen test result to an agency? these Guidelines only to the extent 13.23 Where is the list of HHS-certified 15.15 How long must an HHS-certified laboratory retain a split specimen? agreed to by the head of the affected IITFs published? Agency; and Subpart N—Medical Review Officer (MRO) Subpart P—Criteria for Rejecting a (5) Laboratories, instrumented initial Specimen for Testing 14.1 Who may serve as an MRO? test facilities, and point of collection 14.2 What are the training requirements 16.1 What discrepancies require an HHS- tests that provide drug testing services before a physician can serve as an MRO? certified laboratory or IITF to report a to the Federal agencies. 14.3 What are the responsibilities of an hair, oral fluid, sweat, or urine specimen (b) The Guidelines do not apply to MRO? as rejected for testing? drug testing under authority other than 14.4 What must an MRO do when 16.2 What discrepancies require an HHS- Executive Order 12564, including reviewing a hair test result? certified laboratory or IITF to report a testing of persons in the criminal justice 14.5 What must an MRO do when hair, oral fluid, sweat, or urine specimen system, such as, arrestees, detainees, reviewing an oral fluid test result? as rejected for testing unless the probationers, incarcerated persons, or discrepancy is corrected? 14.6 What must an MRO do when parolees.1 reviewing a sweat patch test result? 16.3 What discrepancies are not sufficient to require an HHS-certified laboratory or 14.7 What must an MRO do when 1 reviewing a urine test result? IITF to reject a hair, oral fluid, sweat, or Although HHS has no authority to regulate the transportation industry, the Department of 14.8 Who may request a test of a split urine specimen for testing or an MRO to Transportation (DOT) does have such authority. specimen? cancel a test? DOT is required by law to develop requirements for 14.9 How does the MRO report a primary 16.4 What discrepancies may require an its regulated industry that ‘‘incorporate the specimen test result to an agency? MRO to cancel a test? Department of Health and Human Services

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Section 1.2 Who Is Responsible For Calibrator. A solution of known Donor. The individual from whom a Developing and Implementing These concentration in the appropriate matrix specimen is collected. Guidelines? that is used to define expected outcomes Failed to Reconfirm. The result (a) Executive Order 12564 and Public of a measurement procedure or to reported when a laboratory is unable to Law 100–71 require the Department of compare the response obtained with the corroborate the original result (i.e., Health and Human Services (HHS) to response of a test specimen aliquot/ positive, adulterated, substituted) establish scientific and technical sample. The concentration of the reported to the medical review officer. guidelines for Federal workplace drug analyte of interest in the calibrator is Federal Drug Testing Custody and testing programs. known within limits ascertained during Control Form (Federal CCF). The Office (b) The Secretary has the its preparation. Calibrators may be used of Management and Budget (OMB) responsibility to implement these to establish a calibration curve over a approved form that is used to document Guidelines. range of interest. the collection, custody, and transport of Canceled Test. The MRO determines a specimen from the time the specimen Section 1.3 How Does a Federal that the result reported by the laboratory is collected until it is received by the Agency Request a Change From These cannot support reporting either a testing site (i.e., certified laboratory, Guidelines? positive or a negative test to the instrumented initial test facility). The (a) Each Federal agency must ensure employer. form may also be used to report the test that its workplace drug testing program Certifying Scientist (CS). The result to the Medical Review Officer. complies with the provisions of these individual responsible for verifying the Follow-up Test. A specimen collected Guidelines unless a waiver has been chain of custody and scientific from a donor to ensure that the donor obtained from the Secretary. reliability of a non-negative or invalid remains drug-free after being reinstated (b) To obtain a waiver, a Federal test result. to a testing designated position. agency must submit a written request to Certifying Technician (CT). The HHS. The Department of Health and the Secretary that describes the specific individual responsible for verifying the Human Services. change for which a waiver is sought and chain of custody and scientific Initial Drug Test. The test used to a detailed justification for the change. reliability of a negative test result. differentiate a negative specimen from Chain of Custody (COC). Procedures one that requires further testing for Section 1.4 How Are These Guidelines to account for the integrity of each drugs or drug metabolites. Revised? specimen or aliquot by tracking its Initial Validity Test. The first test (a) In order to ensure the full handling and storage from point of used to determine if a specimen is reliability and accuracy of drug and specimen collection to final disposition adulterated, diluted, or substituted. validity tests, the accurate reporting of of the specimen and its aliquots. Instrumented Initial Test Facility test results, and the integrity and Chain of Custody Document. A (IITF). A location where initial testing, efficacy of Federal drug testing document used by a laboratory to reporting of results, and recordkeeping programs, the Secretary may make maintain the security of the specimen are performed under the supervision of changes to these Guidelines to reflect and all aliquots of a specimen during a responsible technician. improvements in the available science testing and storage. The document, Invalid Result. The result reported and technology. which may account for an entire test when a scientifically supportable (b) The changes will be published in batch, must include the names and analytical test result cannot be final as a notice in the Federal Register. signatures of all individuals who established for a specimen. handled the specimen or aliquots and Laboratory. A location where initial Section 1.5 What Do the Terms Used and confirmatory testing is performed in These Guidelines Mean? the date and purpose of the access. Collection Site. A place where donors under the supervision of an RP and The following definitions are adopted: present themselves for the purpose of where CSs perform the final review and Accessioner. The individual who providing a specimen. release of test results. receives the specimens at the laboratory Collector. A person who instructs and Medical Review Officer (MRO). A or IITF and signs the Federal drug assists donors at a collection site and licensed physician who reviews, testing custody and control form. receives the specimen provided by the verifies, and reports a specimen test Aliquot. A fractional part of a donor. result to the agency. specimen used for testing. It is taken as Confirmatory Drug Test. A second Negative Result. The result reported a sample representing the whole analytical procedure performed on a by an HHS-certified laboratory, IITF, or specimen. different aliquot of the original POCT tester to an MRO when a Adulterated. A specimen containing specimen to identify and quantify the specimen contains no drug or the either a substance that is not a normal presence of a specific drug or drug concentration of the drug is less than constituent for that type of specimen or metabolite. the cutoff concentration for that drug or containing an endogenous substance at Confirmatory Validity Test. A second drug class. a concentration that is not a normal test performed on a different aliquot of Non-Negative Result. The result physiological concentration. the original specimen to further support reported by an HHS-certified laboratory Batch. A number of specimens that a validity test result. when a specimen is either adulterated, are being handled and tested as a group. Control. A sample used to evaluate substituted, or contains a drug or drug whether an analytical procedure or test metabolite at or above the established scientific and technical guidelines dated April 11, is operating within predefined tolerance cutoff concentration. 1988, and any amendments to those guidelines ***’’ See, e.g., 49 U.S.C. 20140(c)(2). In carrying limits. Oxidizing Adulterant. A substance out its mandate, DOT requires by regulation that its Cutoff. The concentration used to that acts alone or in combination with federally-regulated employers use only HHS- establish and report a specimen as other substances to oxidize drug or drug certified laboratories in the testing of employees, 49 negative or positive. metabolites to prevent the detection of CFR 40.81, and incorporates the scientific and technical aspects of the guidelines in its Dilute Specimen. Refers to a specimen the drugs or drug metabolites, or affects regulations. The DOT regulated industry should with less than normal physiological the reagents in either the initial or refer to the DOT regulations at 49 CFR part 40. constituents. confirmatory drug test. Examples of

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these agents include, but are not limited Sample. A representative portion of a Section 2.2 Under What to, nitrites, pyridinium chlorochromate, specimen or quality control material Circumstances Can the Different Types chromium (VI), bleach, iodine, used for testing. of Specimens Be Collected? halogens, peroxidase, and peroxide. Secretary. The Secretary of Health and Performance Testing (PT) Sample. A Human Services or the Secretary’s Type of Reason for test sample sent to a testing facility that is designee. The Secretary’s designee may specimen used to evaluate the performance of a be a contractor or other recognized Hair ...... Pre-employment, random, facility’s test procedure. organization which acts on behalf of the return to duty, follow-up Point of Collection Test (POCT). A Secretary in implementing these Oral Fluid ...... Pre-employment, random, drug or validity test conducted at a Guidelines. reasonable suspicion/ collection site to obtain a preliminary Specimen. Fluid or material derived cause, post-accident result as to whether a specimen may from the body which may be Sweat (patch) Return to duty, follow-up contain a drug/drug metabolite or is not subdivided, concurrently collected, or Urine ...... Pre-employment, random, a valid specimen. two specimens collected almost reasonable suspicion/ POCT Site. A collection site where a simultaneously if a split specimen is cause, post-accident, re- point of collection test is conducted. required. turn to duty, follow-up Positive Result. The result reported by Split Specimen. A specimen collected a laboratory when a specimen contains at the collection site that is fluid or Section 2.3 Can More Than One Type a drug or drug metabolite greater than or material derived from the body which of Specimen Be Collected at the Same equal to the cutoff concentration. has been subdivided or concurrently Time From the Same Donor? Post-accident Test. A specimen collected and independently sealed in Yes, more than one type of specimen collected from a donor after the donor the presence of the donor. For urine, may be collected at the same time from is involved in a job-related accident. one void that is subdivided. For hair, the donor, but only in the following Pre-employment Test. A specimen one harvest that is subdivided by circumstances: collected from a donor who is applying strands. For oral fluid, one specimen (a) When an oral fluid specimen is for a testing designated position. collected that is subdivided or two collected, a urine specimen must also be Quality Control (QC) Sample. A specimens collected almost collected; or calibrator, control, or negative sample. simultaneously. For sweat, two separate (b) If a problem occurs during the patches that are applied and removed These samples are collectively referred collection of one type of specimen (e.g., simultaneously. to as ‘‘quality control samples’’ and each shy bladder for a urine specimen, as a ‘‘sample.’’ Standard. Reference material of known purity or a solution containing a insufficient specimen available), Random Test. A specimen collected permission can be obtained from the from a donor who is selected at random reference material at a known concentration. Federal agency to collect an alternative from a group of individuals who are specimen. included in a workplace drug testing Substituted. A specimen that could program. not have been derived from the donor’s Section 2.4 How Is Each Type of Reasonable Suspicion/Cause Test. A body at the time of collection because it Specimen To Be Collected? is inconsistent with normal physiology. specimen collected from a donor when Each type of specimen is to be there is sufficient evidence to indicate Section 1.6 What Is an Agency collected as a split specimen as that the donor may have used an illicit Required To Do To Protect Employee described in section 2.5. substance. Records? Reconfirmed. The result reported Section 2.5 What Is the Minimum when a laboratory is able to corroborate Consistent with 5 U.S.C. 522a(m) and Quantity of Specimen To Be Collected the original result (i.e., positive, 48 CFR 24.101–24.104, all agency for Each Type of Specimen? contracts with laboratories, IITFs, POCT adulterated, substituted) reported to the (a) Hair: 100 mg head hair (divided as Medical Review Officer. testers, collectors, and MROs must require that they comply with the follows: 2 samples with approximately Rejected for Testing. The result 50 mg per sample) reported by a laboratory or test facility Privacy Act, 5 U.S.C. 522a. In addition, the contracts must require compliance (b) Oral Fluid: 2 mL collected as a when it does not perform any tests on ‘‘neat specimen’’ (divided as follows: at the specimen because of a fatal flaw or with employee access and confidentiality provisions of section 503 least 1.5 mL for the primary specimen an unrecovered correctable error. and at least 0.5 mL for the split Responsible Person (RP). The person of Public Law 100–71. The agency must specimen) who assumes professional, establish a Privacy Act System of (c) Sweat: 2 FDA-cleared patches organizational, educational, and Records or modify an existing system, or worn up to 7 days administrative responsibility for the use any applicable Government-wide (d) Urine: 45 mL (divided as follows: day-to-day management of the HHS- system of records to cover the records of at least 30 mL for the primary specimen certified laboratory. employee drug test results. All contracts and at least 15 mL for the split Responsible Technician (RT). The and the Privacy Act System of Records specimen) person who assumes professional, must specifically require that employee organizational, educational, and records be maintained and used with Subpart C—Drug and Validity Tests administrative responsibility for the the highest regard for employee privacy. Section 3.1 Which Tests Must Be day-to-day management of the HHS- Subpart B—Specimens Performed on a Specimen? certified instrumented initial test facility. Section 2.1 What Types of Specimens (a) Federal agency applicant and Return to Duty Test. A specimen May Be Collected? random drug testing programs must at a collected from a donor to ensure that the A Federal agency may collect head minimum test for marijuana and donor is drug free prior to being hair, oral fluid (saliva), sweat (patch), or cocaine; reinstated in a testing designated urine for its workplace drug-testing (b) Federal agency applicant and position. program in keeping with section 2.2. random drug testing programs are also

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authorized to test for opiates, CONFIRMATORY TEST CUTOFF 2 Specimen must also contain Amphetamine at a concentration greater than or equal to the amphetamines, and phencyclidine; and CONCENTRATION limit of detection. (c) Each specimen must be tested to determine if it is a valid specimen. (pg/mg) Section 3.6 What Are the Cutoff Concentrations for Sweat Patch Section 3.2 Can a Specimen Be Tested Marijuana metabolite 1 ...... 0.05 Samples? for Additional Drugs? Cocaine: Cocaine 2 ...... 500 INITIAL TEST CUTOFF CONCENTRATION (a) Any specimen collected from a Cocaine metabolites 2 ...... 50 donor that is suspected to contain a Opiates: (ng/patch) Schedule I or II drug of the Controlled Morphine ...... 200 Substances Act (other than the drugs Codeine ...... 200 Marijuana metabolites ...... 4 6–Acetylmorphine 3 ...... 200 listed in section 3.1, or when used Cocaine metabolites ...... 25 Phencyclidine ...... 300 Opiate metabolites 1 ...... 25 pursuant to a valid prescription or when Amphetamines: Phencyclidine ...... 20 used as otherwise authorized by law) Amphetamine ...... 300 Amphetamines 2 ...... 25 may be tested for that drug on a case- Methamphetamine 4 ...... 300 MDMA ...... 25 by-case basis. The Federal agency must MDMA ...... 300 1 Labs are permitted to initial test all speci- request the HHS-certified laboratory to MDA ...... 300 mens for 6–AM at 25 ng/patch. test for that additional drug, include a MDEA ...... 300 2 Methamphetamine is the target analyte. justification to test a specific specimen 1 Delta–9–tetrahydrocannabinol–9–car- for the drug, and ensure that the HHS- boxylic acid. CONFIRMATORY TEST CUTOFF certified laboratory has the capability to 2 Cocaine concentration is greater than or CONCENTRATION equal to confirmatory cutoff and test for the drug and has established Benzoylecgonine (BZE)/Cocaine ratio is great- properly validated initial and er than or equal to 0.05 or Cocaethylene (CE) (ng/patch) confirmatory analytical methods. greater than or equal to 50 pg/mg or norcocaine (NC) greater than or equal to 50 THC parent drug ...... 1 (b) A Federal agency covered by these pg/mg. Cocaine 1 ...... 25 Guidelines must petition the Secretary 3 Specimen must also contain Morphine at a Opiates 2 ...... 25 in writing for approval to routinely test concentration greater than or equal to 200 pg/ Phencyclidine ...... 20 for any drug class not listed in section mg. Amphetamines: 4 Specimen must also contain Amphetamine Amphetamine ...... 25 3.1. Such approval must be limited to at a concentration greater than or equal to 50 Methamphetamine 3 ...... 25 the use of the appropriate science and pg/mg. MDMA ...... 25 technology and must not otherwise limit Section 3.5 What Are the Cutoff MDA ...... 25 agency discretion to test for any drug MDEA ...... 25 Concentrations for Oral Fluid tested under paragraph (a) of this Specimens? 1 Cocaine or Benzoylecgonine. section. 2 Morphine, Codeine, or 6-Acetylmorphine. 3 Specimen must also contain Amphetamine Section 3.3 May Any of the Specimens INITIAL TEST CUTOFF CONCENTRATION at a concentration greater than or equal to the Be Used for Other Purposes? limit of detection. (ng/mL) (a) Federal agency specimens Section 3.7 What Are the Cutoff collected pursuant to Executive Order THC Parent drug and metabolite ... 4 Concentrations for Urine Specimens? 12564, Public Law 100–71, and these Cocaine metabolites ...... 20 Opiate metabolites 1 ...... 40 Guidelines must only be tested for drugs INITIAL TEST CUTOFF CONCENTRATION Phencyclidine ...... 10 and to determine their validity unless Amphetamines 2 ...... 50 (ng/mL) otherwise authorized by law. MDMA ...... 50 (b) These Guidelines are not intended Marijuana metabolites ...... 50 1 Labs are permitted to initial test all speci- to prohibit any Federal agency Cocaine metabolites ...... 150 mens for 6-AM using a 4 ng/mL cutoff. 1 specifically authorized by law to test a 2 Methamphetamine is the target analyte. Opiate metabolites ...... 2000 Phencyclidine ...... 25 specimen for additional classes of drugs Amphetamines 2 ...... 500 in its workplace drug testing program. CONFIRMATORY TEST CUTOFF MDMA ...... 500 CONCENTRATION Section 3.4 What Are the Cutoff 1 Labs are permitted to initial test all speci- Concentrations for Hair Samples? mens for 6–AM using a 10 ng/mL cutoff. (ng/mL) 2 Methamphetamine is the target analyte. INITIAL TEST CUTOFF CONCENTRATION THC Parent drug ...... 2 Cocaine 1 ...... 8 CONFIRMATORY TEST CUTOFF (pg/mg) Opiates: CONCENTRATION Morphine ...... 40 Marijuana metabolites ...... 1 Codeine ...... 40 (ng/mL) Cocaine metabolites ...... 500 6-Acetylmorphine ...... 4 1 Opiate metabolites1 ...... 200 Phencyclidine ...... 10 Marijuana metabolite ...... 15 Cocaine metabolite 2 ...... 100 Phencyclidine ...... 300 Amphetamines: Opiates: Amphetamines2 ...... 500 Amphetamine ...... 50 2 Morphine ...... 2000 MDMA ...... 500 Methamphetamine ...... 50 MDMA ...... 50 Codeine ...... 2000 3 1 Laboratories are permitted to initial test all MDA ...... 50 6-acetylmorphine ...... 10 specimens for 6–acetylmorphine (6–AM) using MDEA ...... 50 Phencyclidine ...... 25 a 200 pg/mg cutoff. Amphetamines: 2 Methamphetamine is the target analyte. 1 Cocaine or Benzoylecgonine. Amphetamine ...... 250

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CONFIRMATORY TEST CUTOFF (iii) Possible unidentified interfering concentration of the adulterant is above CONCENTRATION—Continued substance or adulterant. the concentration of the calibrator used (b) The choice of additional validity to verify that the adulterant was present (ng/mL) tests is dependent on the observed in the sample. indicators or characteristics as described Methamphetamine4 ...... 250 in (2)(i) through (iii) of this section. Section 3.13 What Criteria Are Used MDMA ...... 250 To Report an Oral Fluid Specimen as MDA ...... 250 Section 3.10 What Validity Tests Must Adulterated? MDEA ...... 250 Be Performed on a Sweat Patch Sample? A primary (Tube A) oral fluid 1 Delta-9-tetrahydrocannabinol-9-carboxylic (a) For each primary (Patch A) sweat specimen is reported adulterated when acid. patch sample, an HHS-certified the concentration of the adulterant is 2 Benzoylecgonine. laboratory or IITF must: above the concentration of the calibrator 3 If a laboratory uses both initial test kits to (1) Determine the lactic acid screen a specimen concurrently, it may report used to verify that the adulterant was 6–AM alone. concentration on every specimen; and present in the specimen. 4 Specimen must also contain Amphetamine (2) Perform additional validity tests at a concentration greater than or equal to 100 when the following conditions are Section 3.14 What Criteria Are Used ng/mL. observed: To Report a Sweat Patch Sample as Adulterated? Section 3.8 What Validity Tests Must (i) Abnormal physical characteristics Be Performed on a Hair Sample? (e.g., Patch A and Patch B have different A primary (Patch A) sweat patch color, unusual odor); sample is reported adulterated when the (a) For each primary (Sample A) head (ii) Reactions or responses concentration of the adulterant is above hair sample, an HHS-certified laboratory characteristic of an adulterant obtained the concentration of the calibrator used or IITF must: during initial or confirmatory drug tests to verify that the adulterant was present (1) Determine the integrity of the head (e.g., non-recovery of standards, unusual in the sample. hair sample by performing a digestion response); or test; (iii) Possible unidentified interfering Section 3.15 What Criteria Are Used (2) Perform microscopic substance or adulterant. To Report a Urine Specimen as identification; (b) The choice of additional validity Adulterated? (3) Perform a dye test; tests is dependent on the observed A primary (Bottle A) urine specimen (4) Determine solubility of head hair indicators or characteristics as described is reported adulterated when: in methanol; and in (2)(i) through (iii) of this section. (a) The pH is less than 3 or greater (5) Perform additional validity tests than or equal to 11 using either a pH when the following conditions are Section 3.11 What Validity Tests Must meter or a colorimetric pH test for the observed: Be Performed on a Urine Specimen? (i) Abnormal physical characteristics initial test on the first aliquot and a pH (a) For each primary (Bottle A) urine meter for the confirmatory test on the (e.g., Sample A and Sample B have specimen, an HHS-certified laboratory different hair color, mixture of different second aliquot; or IITF must: (b) The nitrite concentration is greater types of head hair); (1) Determine the creatinine than or equal to 500 mcg/mL using (ii) Reactions or responses concentration on every specimen; characteristic of an adulterant obtained either a nitrite colorimetric test or a (2) Determine the specific gravity on general oxidant colorimetric test for the during initial or confirmatory drug tests every specimen for which the creatinine (e.g., non-recovery of standards, unusual initial test on the first aliquot and a concentration is less than 20 mg/dL; different confirmatory test (e.g., multi- response); or (3) Determine the pH on every wavelength spectrophotometry, ion (iii) Possible unidentified interfering specimen; substance or adulterant. (4) Perform one or more validity tests chromatography, capillary (b) The choice of additional validity for oxidizing adulterants on every electrophoresis) on the second aliquot; (c) The presence of chromium (VI) is tests is dependent on the observed specimen; and indicators or characteristics as described (5) Perform additional validity tests verified using either a general oxidant in (5)(i) through (iii) of this section. when the following conditions are colorimetric test (with a greater than or equal to 50 mcg/mL chromium (VI)- Section 3.9 What Validity Tests Must observed: (i) Abnormal physical characteristics equivalent cutoff) or a chromium (VI) Be Performed on an Oral Fluid (e.g., unusual odor or color, semi-solid colorimetric test (chromium (VI) Specimen? characteristics); concentration greater than or equal to 50 (a) For each primary (Tube A) oral (ii) Reactions or responses mcg/mL) for the initial test on the first fluid specimen, an HHS-certified characteristic of an adulterant obtained aliquot and a different confirmatory test laboratory or IITF must: during initial or confirmatory drug tests (e.g., multi-wavelength (1) Determine the immunoglobulins (e.g., non-recovery of standards, unusual spectrophotometry, ion (IgG) concentrations on every specimen; response); or chromatography, atomic absorption and (iii) Possible unidentified interfering spectrophotometry, capillary (2) Perform additional validity tests substance or adulterant. electrophoresis, inductively coupled when the following conditions are (b) The choice of additional validity plasma-mass spectrometry) with the observed: tests is dependent on the observed chromium (VI) concentration greater (i) Abnormal physical characteristics indicators or characteristics as described than or equal to the limit of detection (e.g., unusual color or texture, unusual in (5)(i) through (iii) of this section. (LOD) of the confirmatory test on the odor, semi-solid characteristics); second aliquot; (ii) Reactions or responses Section 3.12 What Criteria Are Used (d) The presence of halogen (e.g., characteristic of an adulterant obtained To Report a Hair Sample as bleach, iodine, fluoride) is verified during initial or confirmatory drug tests Adulterated? using either a general oxidant (e.g., non-recovery of standards, unusual A primary (Sample A) head hair colorimetric test (with a greater than or response); or sample is reported adulterated when the equal to 200 mcg/mL nitrite-equivalent

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cutoff or a greater than or equal to 50 Section 3.17 What Criteria Are Used specimen may damage the laboratory’s mcg/mL chromium (VI)-equivalent To Report a Urine Specimen as instruments; or cutoff) or halogen colorimetric test Substituted? (d) If the physical appearances of (halogen concentration greater than or A primary (Bottle A) urine specimen Tubes A and B are clearly different, the equal to the LOD) for the initial test on is reported substituted when the test result for Tube A is one of the the first aliquot and a different creatinine concentration is less than 2 reasons stated in (a) through (c) of this confirmatory test (e.g., multi-wavelength mg/dL on both the initial and section and/or was screened negative for spectrophotometry, ion confirmatory creatinine tests (i.e., the drugs. chromatography, inductively coupled same colorimetric test may be used to Section 3.21 What Criteria Are Used plasma-mass spectrometry) with a test both aliquots) and the specific To Report a Sweat Patch Sample as an specific halogen concentration greater gravity is less than or equal to 1.0010 or Invalid Result? greater than or equal to 1.0200 on both than or equal to the LOD of the A primary (Patch A) sweat patch the initial and confirmatory specific confirmatory test on the second aliquot; sample is reported as an invalid result gravity tests (i.e., a refractometer is used (e) The presence of glutaraldehyde is when: to test both aliquots) on two separate verified using either an aldehyde test (a) Interference occurs on the aliquots. (aldehyde present) or the characteristic immunoassay drug tests on two separate immunoassay response on one or more Section 3.18 What Criteria Are Used aliquots (i.e., valid immunoassay drug drug immunoassay tests for the initial To Report a Urine Specimen as Dilute? test results cannot be obtained); (b) Interference with the drug test on the first aliquot and gas A primary (Bottle A) urine specimen confirmatory assay occurs on at least chromatography/mass spectrometry is reported dilute when the creatinine two separate aliquots of the specimen (GC/MS) for the confirmatory test with concentration is greater than or equal to and the laboratory is unable to identify the glutaraldehyde concentration greater 2 mg/dL but less than 20 mg/dL and the the interfering substance; specific gravity is greater than 1.0010 than or equal to the LOD of the analysis (c) The physical appearance of the but less than 1.0030 on a single aliquot. on the second aliquot; specimen is such that testing the system (f) The presence of pyridine Section 3.19 What Criteria Are Used may damage the laboratory’s (pyridinium chlorochromate) is verified To Report a Hair Sample as an Invalid instruments; or using either a general oxidant Result? (d) If the physical appearances of colorimetric test (with a greater than or A primary (Sample A) head hair Patches A and B are clearly different, equal to 200 mcg/mL nitrite-equivalent sample is reported as an invalid result the test result for Patch A is one of the cutoff or a greater than or equal to 50 when: reasons stated in (a) through (c) of this mcg/mL chromium (VI)-equivalent (a) Interference occurs on the section and/or was screened negative for cutoff) or a chromium (VI) colorimetric immunoassay drug tests on two separate drugs. test (chromium (VI) concentration aliquots (i.e., valid immunoassay drug Section 3.22 What Criteria Are Used greater than or equal to 50 mcg/mL) for test results cannot be obtained); To Report a Urine Specimen as an the initial test on the first aliquot and (b) Interference with the drug Invalid Result? confirmatory assay occurs on at least GC/MS for the confirmatory test with A primary (Bottle A) urine specimen the pyridine concentration greater than two separate aliquots of the specimen and the laboratory is unable to identify is reported as an invalid result when: or equal to the LOD of the analysis on (a) Inconsistent creatinine the second aliquot; the interfering substance; (c) The physical appearance of the concentration and specific gravity (g) The presence of a surfactant is specimen is such that testing the system results are obtained (i.e., the creatinine verified by using a surfactant may damage the laboratory’s concentration is less than 2 mg/dL on colorimetric test with a greater than or instruments; or both the initial and confirmatory equal to 100 mcg/mL dodecylbenzene (d) If the physical appearances of creatinine tests and the specific gravity sulfonate-equivalent cutoff for the initial Samples A and B are clearly different, is greater than 1.0010 but less than test on the first aliquot and a different the test result for Sample A is one of the 1.0200 on the initial and/or confirmatory test (e.g., multi-wavelength reasons stated in (a) through (c) of this confirmatory specific gravity test, the spectrophotometry) with a greater than section and/or was screened negative for specific gravity is less than or equal to or equal to 100 mcg/mL dodecylbenzene drugs. 1.0010 on both the initial and sulfonate-equivalent cutoff on the confirmatory specific gravity tests and Section 3.20 What Criteria Are Used the creatinine concentration is greater second aliquot; or To Report an Oral Fluid Specimen as an than or equal to 2 mg/dL on either or (h) The presence of any other Invalid Result? both the initial or confirmatory adulterant not specified in (c) through A primary (Tube A) oral fluid creatinine tests); (g) of this section is verified using an specimen is reported as an invalid result (b) The pH is greater than or equal to initial test on the first aliquot and a when: 3 and less than 4.5 or greater than or different confirmatory test on the (a) Interference occurs on the equal to 9 and less than 11 using either second aliquot. immunoassay drug tests on two separate a colorimetric pH test or pH meter for aliquots (i.e., valid immunoassay drug the initial test and a pH meter for the Section 3.16 What Criteria Are Used test results cannot be obtained); confirmatory test on two separate To Report an Oral Fluid Specimen as (b) Interference with the drug aliquots; Substituted? confirmatory assay occurs on at least (c) The nitrite concentration is greater than or equal to 200 mcg/mL using a A primary (Tube A) oral fluid two separate aliquots of the specimen and the laboratory is unable to identify nitrite colorimetric test or greater than specimen is reported substituted when the interfering substance; or equal to the equivalent of 200 mcg/ the IgG concentration is less than 0.10 (c) The physical appearance of the mL nitrite using a general oxidant mcg/mL. specimen is such that testing the colorimetric test for both the initial test

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and the confirmatory test or using either section and/or was screened negative for Federal agency that employs its own initial test and the nitrite concentration drugs. collectors) must: is greater than or equal to 200 mcg/mL (a) Ensure that each individual that Subpart D—Collectors but less than 500 mcg/mL for a different serves as a collector has been properly confirmatory test (e.g., multi-wavelength Section 4.1 Who May Collect a trained before the individual is spectrophotometry, ion Specimen? permitted to collect a specimen; chromatography, capillary (b) Maintain a copy of the records that (a) An individual who has been electrophoresis) on two separate document the collector’s training; and trained to collect a particular type of aliquots; (c) Provide to the collector the name (d) The possible presence of specimen (i.e., head hair, oral fluid, and telephone number of the Federal chromium (VI) is determined using the sweat, or urine). agency representative to contact about same chromium (VI) colorimetric test (b) The immediate supervisor of a problems or issues that may arise during with a cutoff greater than or equal to 50 donor may not act as the collector when a specimen collection procedure. mcg/mL chromium (VI) for both the that donor is tested unless no other Subpart E—Collection Sites initial test and the confirmatory test on collector is available. two separate aliquots; (c) An employee working for a testing Section 5.1 Where Can a Collection for (e) The possible presence of a halogen facility must not act as a collector if the a Drug Test Take Place? (e.g., bleach, iodine, fluoride) is employee could link the identity of the donor to the donor’s drug test result. (a) A collection site may be a determined using the same halogen permanent or temporary facility located colorimetric test with a cutoff greater Section 4.2 What Are the either at the work site or at a remote than or equal to the LOD for both the Requirements To Be a Trained Collector site. initial test and the confirmatory test on For a Federal Agency? (b) The selection of an appropriate two separate aliquots or relying on the An individual is considered to be a collection site will depend on the type odor of the specimen as the initial test; of specimen being collected. For (f) The possible presence of trained collector for a particular type of specimen when the individual has: example, a urine specimen is normally glutaraldehyde is determined by using collected in some type of restroom, the same aldehyde test (aldehyde (a) Read and understands these Guidelines; while a head hair sample may be present) or characteristic immunoassay collected in a private office. response on one or more drug (b) Read and understands any immunoassay tests for both the initial guidance provided by the Federal Section 5.2 What Are the test and the confirmatory test on two agency, which is consistent with these Requirements for a Collection Site? Guidelines; separate aliquots; A facility that is used as a collection (g) The possible presence of an (c) Demonstrated proficiency by completing five consecutive error-free site must have the following: oxidizing adulterant is determined by (a) A suitable clean surface for mock collections for a particular type of using the same general oxidant handling the specimen and completing specimen; and colorimetric test (with a greater than or the required paperwork; (d) Successfully completed a training equal to 200 mcg/mL nitrite-equivalent (b) A secure temporary storage course by an established organization cutoff, a greater than or equal to 50 mcg/ capability to maintain a specimen until for the particular type or types of mL chromium (VI)-equivalent cutoff, or it is tested or shipped to the laboratory; a halogen concentration is greater than specimen(s) for which the individual is (c) The ability to provide the donor or equal to the LOD) for both the initial being trained. privacy that is appropriate for the test and the confirmatory test on two Section 4.3 How Is a Collector’s specimen being collected; separate aliquots; Training Documented? (d) The ability to restrict access to (h) The possible presence of a only authorized personnel during the (a) A trainer must monitor and surfactant is determined by using the collection; same surfactant colorimetric test with a evaluate the knowledge and (e) The ability to restrict access to greater than or equal to 100 mcg/mL performance of the individual being collection supplies; and dodecylbenzene sulfonate-equivalent trained, in person or by means that (f) The ability to store records cutoff for both the initial test and the provides real-time observation and securely. confirmatory test on two separate interaction between the trainer and aliquots or a foam/shake test for the trainee, and attest in writing that the Section 5.3 How Long Must Collection initial test; mock collections are error-free. Site Records Be Stored? (i) Interference occurs on the (b) The trainer must be an individual Collection site records must be stored immunoassay drug tests on two separate who has demonstrated necessary for a minimum of 2 years by the aliquots (i.e., valid immunoassay drug knowledge, skills, and abilities by collector or the collector’s employer. test results cannot be obtained); having: (j) Interference with the drug (1) Regularly conducted collections Section 5.4 How Does the Collector confirmatory assay occurs on at least for a period of at least one year; or Ensure the Security of a Specimen at the two separate aliquots of the specimen (2) Successfully completed a ‘‘train Collection Site? and the laboratory is unable to identify the trainer’’ course given by an (a) A collector must do the following the interfering substance; established organization. to maintain the security of a specimen: (k) The physical appearance of the (1) Not allow unauthorized personnel Section 4.4 What Must an specimen is such that testing the system to enter the collection site during the Organization Do Before a Collector Is may damage the laboratory’s collection; Permitted To Collect Specimens for a instruments; or (2) Perform only one specimen (l) If the physical appearances of Federal Agency? collection at a time; Bottles A and B are clearly different, the An organization (e.g., self-employed (3) Restrict access to collection test result for Bottle A is one of the individual, third party administrator supplies before and during the reasons stated in (a) through (j) of this that provides a collection service, collection;

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(4) Ensure that he or she is the only (c) The agency believes that the donor (1) If a collection device has been person other than the donor to handle may tamper with or substitute the cleared by the FDA for the purpose of the unsealed specimen; specimen to be provided; or testing a specimen for drugs, it is (5) Ensure that chain of custody is (d) During a routine collection, the deemed not to affect the specimen maintained and documented throughout temperature of the specimen collected is collected. the entire collection procedure; outside the acceptable range, the (2) If a collection device has not been (6) Ensure that specimens transported collector observed materials brought to cleared by the FDA, a Federal agency to an HHS-certified laboratory or IITF the collection site or donor conduct must only use a device that does not are placed in containers that will indicated a possible attempt to affect the specimen collected. minimize the possibility of damage adulterate or substitute a specimen, or (b) These Guidelines do not determine during shipment (e.g., specimen boxes the collector believes that the specimen if a collection device must be cleared by or padded mailers); and has been adulterated (e.g., the specimen the FDA. (7) Ensure that the Federal CCF is is blue, exhibits excessive foaming when shaken, has smell of bleach). Subpart H—Specimen Collection enclosed with the split specimens Procedure within each container that is sealed for Subpart F—Federal Drug Testing shipment to the HHS-certified Custody and Control Forms Section 8.1 What Must the Collector laboratory or IITF. Do Before Starting a Specimen Section 6.1 What Form Is Used for (b) Since specimens are sealed in Collection Procedure? Collecting a Specimen? packages that would indicate any The collector must: tampering during transit to the HHS- (a) Federal agencies are required to (a) Provide identification to the donor certified laboratory or IITF and couriers, use an OMB-approved Federal CCF to if the donor asks; express carriers, and postal service document the collection of each type of (b) Explain the basic collection personnel do not have access to the specimen at the collection site. procedure to the donor; Federal CCF or split specimens, there is (b) There is a separate OMB-approved (c) Request the donor to read the no requirement that such personnel Federal CCF for each type of specimen instructions on the back of the Federal document chain of custody for the collected. CCF; and package during transit. Section 6.2 What Happens if a Federal (d) Answer any reasonable and Section 5.5 What Are the Privacy CCF Is Not Available or Is Not Used? appropriate questions the donor may Requirements When Collecting a Hair (a) When the collector either by have regarding the collection procedure. Sample? mistake or as the only means to Section 8.2 What Procedure Is Used To document a collection under difficult The collector collects head hair from Collect a Head Hair Sample? circumstances (e.g., post-accident test the donor. The donor must be allowed (a) The collector must use the with insufficient time to obtain the CCF) privacy while the collector obtains the following procedure to collect a head uses a non-Federal form for a Federal head hair sample. agency specimen collection, the use of hair sample: (1) When the donor arrives at the Section 5.6 What Are the Privacy a non-Federal form is not a reason for collection site, the collector shall Requirements When Collecting an Oral the laboratory to reject the specimen for request the donor to present photo Fluid Specimen? testing or for the MRO to cancel the test. (b) If the testing facility or the MRO identification. If the donor does not The donor provides the sample discovers the use of the incorrect form, have proper photo identification, the directly into an appropriate container a signed statement must be obtained collector shall contact the supervisor of under the direct observation of the from the collector stating the reason the donor or an agency representative collector. Only the collector may be why a Federal CCF was not used to who can positively identify the donor. present while the donor provides the collect the Federal agency specimen. If the donor’s identity cannot be oral fluid specimen. established, the collector must not Subpart G—Collection Device proceed with the collection. Section 5.7 What Are the Privacy (2) If the donor fails to arrive at the Requirements When Collecting a Sweat Section 7.1 What Is a Collection assigned time or if the donor fails to Patch Sample? Device? remain present through the completion The sweat patch is applied to the A collection device, for the purposes of the collection, the collector must donor’s upper arm or back by the of these Guidelines, is considered to be contact the agency to obtain guidance collector. The donor must be allowed the following for each type of specimen on the action to be taken. collected: privacy while the collector applies or (3) The collector shall ask the donor (a) For urine, it is the single-use removes the patch. to remove any unnecessary outer plastic specimen container. Section 5.8 What Are the Privacy (b) For head hair, it is the foil or other garments such as a coat or jacket and Requirements When Collecting a Urine specimen guide and single-use plastic any hat or hood. Specimen? bag or other container in which the (4) The collector must use a Federal specimen is placed. CCF to document collecting a head hair The collector must give the donor (c) For oral fluid, it is the single-use sample. visual privacy while providing the plastic specimen container. (5) In the presence of the donor, the specimen unless: (d) For sweat, it is the patch placed on collector must clean the scissors that (a) A previous drug test was reported the skin. will be used to cut the head hair with either positive for a drug, adulterated, an alcohol wipe prior to obtaining a substituted, invalid result, or canceled Section 7.2 Which Collection Devices head hair sample. because the split specimen was not May Be Used? (6) If the collector sees any evidence tested; (a) Only a collection device that does that the donor has lice in his or her head (b) The drug test is a return-to-duty or not affect the specimen collected may be hair, the collector immediately stops the a follow-up test; used. collection procedure and contacts the

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agency to obtain permission to collect a who can positively identify the donor. (9) The Tube A specimen, containing different type of specimen. If the donor’s identity cannot be a minimum of 1.5 mL of oral fluid, is (7) Using scissors, the collector will established, the collector must not to be used for the drug test. If there is cut the donor’s head hair in a line near proceed with the collection. no additional oral fluid available for the the rear of the crown toward the back (2) If the donor fails to arrive at the second specimen tube (Tube B), the first and as close to the scalp as possible. assigned time or if the donor fails to specimen tube (Tube A) shall Approximately one-and-one-half inches remain present through the completion nevertheless be processed for testing. of the hair closest to the scalp is actually of the collection, the collector must (10) A minimum of 0.5 mL of oral tested, even if the head hair is long. If contact the appropriate authority to fluid shall be transferred into the second the hair is less than one-and-one-half obtain guidance on the action to be specimen tube (Tube B). inches long, then the width of the taken. (11) The collector places a tamper- sample collected will need to be (3) The collector shall ask the donor evident label/seal from the Federal CCF increased. The weight of hair needed for to remove any unnecessary outer across the top of each tube and records testing is 100 mg. The head hair sample garments such as a coat or jacket that the date of the collection on the tamper- collected from the donor must meet that might conceal items or substances that evident labels/seals. requirement. could be used to tamper with or (12) The donor initials the tamper- (8) The collector places the head hair adulterate the donor’s oral fluid evident labels/seals on the specimen sample in the foil packet (collection specimen. The collector must ensure tubes. device), root-end extending out that all personal belongings such as a (13) The collector asks the donor to approximately one-quarter inch from purse or briefcase remain with the outer read and sign a statement on the Federal the slated end of the foil. The collector garments. The donor may retain his or CCF certifying that the specimen then subdivides the head hair sample her wallet. The collector directs the identified as having been collected from into two approximately equal head hair donor to empty his or her pockets and him or her. samples (Sample A and Sample B). display the items to ensure that no items (14) The collector must sign the Sample B is placed in a second foil. are present that could be used to Federal CCF. (9) The collector folds both foils adulterate the specimen. If nothing is (15) The split oral fluid specimen and lengthwise and each sample is placed there that can be used to adulterate a Federal CCF are now ready for transfer inside an envelope with root-ends to the specimen, the donor places the items to an HHS-certified laboratory or IITF. (16) After completing the oral fluid left. back into the pockets and the collection specimen collection procedure, the (10) The collector places the seals procedure continues. If the donor collector must also collect a urine from the Federal CCF on the bottom of refuses to show the collector the items specimen following the procedures the envelopes and records the date of in his or her pockets, this is considered described in section 8.5. the collection on the tamper-evident a ‘‘refusal to test.’’ If an item is found (17) The collector must send the oral labels/seals. that appears to have been brought to the fluid and urine split specimens at the (11) The donor initials the tamper- collection site with the intent to same time to an HHS-certified evident labels/seals. adulterate or if the item appears to be laboratory or IITF or transfer the (12) The collector asks the donor to inadvertently brought to the collection specimens to the POCT tester (if a POCT read and sign a statement on the Federal site, the collector must secure the item CCF certifying that the head hair is being conducted). and continue with the normal collection (b) If the split specimens and Federal samples were collected from him or her. procedure. (13) The collector must sign the CCF are not immediately prepared for (4) The collector must confirm with Federal CCF. transfer to an HHS-certified laboratory (14) The split head hair samples and the donor that the donor has not had or IITF or tested using a POCT, they Federal CCF are now ready for transfer anything in his or her mouth for 10 must be appropriately safeguarded until to an HHS-certified laboratory or IITF. minutes prior to providing the oral fluid the specimens and Federal CCF are (15) The collector must send the split specimen. If the donor has had anything prepared for transfer to an HHS-certified (Sample A and Sample B) head hair in his or her mouth within the last 10 laboratory or IITF or tested using a samples at the same time to the HHS- minutes, wait 10 minutes prior to POCT. certified laboratory or IITF. beginning the collection process. (b) If the split head hair samples and (5) The collector will give the donor Section 8.4 What Procedure Is Used To Federal CCF are not immediately a clean specimen tube. Collect a Sweat Patch Sample? prepared for transfer to an HHS-certified (6) Under direct observation, the (a) The collector must use the laboratory or IITF, they must be collector will instruct the donor to following procedure to collect a sweat appropriately safeguarded until the expectorate (to spit) 2 mL of oral fluid patch sample: head hair samples and Federal CCF are into the specimen tube. This can be (1) When a donor arrives at the prepared for transfer to the laboratory. accomplished over a 15 minute time collection site, the collector shall period or until the appropriate volume request the donor to present photo Section 8.3 What Procedure Is Used To of specimen is collected. identification. If the donor does not Collect an Oral Fluid Specimen? (7) Both the donor and the collector have proper photo identification, the (a) The collector must use the must keep the specimen tube in view at collector shall contact the supervisor of following procedure to collect an oral all times prior to its being sealed and the donor or an agency representative fluid specimen: labeled. who can positively identify the donor. (1) When a donor arrives at the (8) The collector, in the presence of If the donor’s identity cannot be collection site, the collector shall the donor, mixes the specimen and established, the collector must not request the donor to present photo transfers the oral fluid into two proceed with the collection. identification. If the donor does not specimen tubes that are labeled Tube A (2) If the donor fails to arrive at the have proper photo identification, the and Tube B. A minimum of 2 mL of oral assigned time or if the donor fails to collector shall contact the supervisor of fluid is required, i.e., 1.5 mL for Tube remain present through the completion the donor or an agency representative A and 0.5 mL for Tube B. of the collection, the collector must

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contact the appropriate authority to indicating that the sweat patches may obtain guidance on the action to be obtain guidance on the action to be not be valid samples (e.g., the donor taken. taken. tampered with the sweat patches). (4) The collector shall ask the donor (3) The collector shall ask the donor (10) Samples suspected of not being to remove any unnecessary outer to remove any unnecessary outer valid sweat patch samples must be garments such as a coat or jacket that garments such as a coat or jacket that forwarded to an HHS-certified might conceal items or substances that might conceal items or substances that laboratory or IITF for testing with any could be used to adulterate or substitute could be used to tamper with or unusual findings noted on the Federal the urine specimen. The collector must adulterate the sweat patch. The collector CCF. ensure that all personal belongings such must ensure that all personal belongings (11) The collector must place the as a purse or briefcase remain with the such as a purse or briefcase remain with sweat patches in appropriate containers outer garments. The donor may retain the outer garments. The donor may and secure them with tamper-evident his or her wallet. The collector directs retain his or her wallet. The collector labels/seals. The collector must record the donor to empty his or her pockets directs the donor to empty his or her the date of the collection on the tamper- and display the items to ensure that no pockets and display the items to ensure evident labels/seals. items are present that could be used to that no items are present that could be (12) The donor must initial the adulterate or substitute the specimen. If used to adulterate the sweat patch. If tamper-evident labels/seals. nothing is there that can be used to nothing is there that can be used to (13) The donor must be asked to read adulterate or substitute a specimen, the adulterate the sweat patch, the donor and sign a statement on the Federal CCF donor places the items back into the places the items back into the pockets certifying that the sweat patch identified pockets and the collection procedure and the collection procedure continues. as having been collected from him or continues. If the donor refuses to show If the donor refuses to show the her. the collector the items in his or her collector the items in his or her pockets, (14) The collector must sign the pockets, this is considered a ‘‘refusal to this is considered a ‘‘refusal to test.’’ If Federal CCF. test.’’ If an item is found that appears to an item appears to be inadvertently (15) The split sweat patch samples have been brought to the collection site brought to the collection site, the and Federal CCF are now ready for with the intent to adulterate or collector must secure the item and transfer to an HHS-certified laboratory substitute the specimen, a direct continue with the normal collection or IITF. observation collection procedure is procedure. (16) The collector must send the split used. If the item appears to be (4) The collector will show the donor specimens at the same time to an HHS- inadvertently brought to the collection two clean sealed sweat patches. certified laboratory or IITF. site, the collector must secure the item (5) The collector asks the donor to (b) If the specimen and Federal CCF and continue with the normal collection thoroughly clean the skin area with soap are not immediately prepared for procedure. and cool water or with a disposable transfer to the laboratory or IITF, they (5) The donor shall be instructed to towelette and then the collector must must be appropriately safeguarded until wash and dry his or her hands prior to thoroughly clean the skin area with the specimen and Federal CCF are urination. alcohol wipes where the sweat patches prepared for transfer to the laboratory or (6) After washing hands, the donor will be worn prior to application. IITF. must remain in the presence of the (6) The collector will place the two collector and must not have access to sweat patches on the upper arm Section 8.5 What Procedure Is Used To any water fountain, faucet, soap (preferable location) or the back. Collect a Urine Specimen? dispenser, cleaning agent, or any other (7) The donor must wear the sweat (a) The collector must use the materials which could be used to patches for no less than three and no following procedure to collect a urine adulterate the specimen. more than seven days before returning specimen: (7) The collector will provide the to the collection site. A unique number (1) To deter the dilution of a specimen donor a clean specimen collection is imprinted on each patch to aid with at the collection site, a toilet bluing container. The donor may provide his/ chain-of-custody identification. On rare agent shall be placed in a toilet tank her specimen in the privacy of a stall or occasions, the sweat patch can produce wherever possible, so the reservoir of otherwise partitioned area that allows an allergic reaction similar to that for water in the toilet bowl always remains for individual privacy. other adhesive bandage products. When blue. There must be no other source of (8) The collector shall note any this occurs, the donor shall return to the water (e.g., no shower or sink) in the unusual behavior or appearance on the collection site and the collector must enclosure where urination occurs. Federal CCF. remove the sweat patch and then (2) When a donor arrives at the (9) In the exceptional event that an request permission from the Federal collection site, the collector shall agency-designated collection site is not agency to collect another type of request the donor to present photo accessible and there is an immediate specimen. The sweat patch procedure is identification. If the donor does not requirement for specimen collection cancelled by the collector and notifies have proper photo identification, the (e.g., an accident investigation), a public the medical review officer and the collector shall contact the supervisor of rest room may be used according to the Federal agency. the donor, the coordinator of the drug following procedures: A person of the (8) After the sweat patches (Sample A testing program, or any other agency same gender as the donor shall and Sample B) are worn for the proper official who can positively identify the accompany the donor into the public time, the donor returns to the collection donor. If the donor’s identity cannot be rest room which must be made secure site. The collector removes the two established, the collector must not during the collection procedure. If sweat patches from the donor within proceed with the collection. possible, a bluing agent shall be placed several minutes. (3) If the donor fails to arrive at the in the bowl and any accessible toilet (9) Immediately before and after the assigned time or if the donor fails to tank. The collector shall remain in the sweat patches are removed, the collector remain present through the completion rest room, but outside the stall, until the must inspect the two sweat patches to of the collection, the collector must specimen is collected. If no bluing agent determine if there are any signs contact the appropriate authority to is available to deter specimen dilution,

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the collector shall instruct the donor not (15) A specimen suspected of not transfer to a POCT tester (if a POCT is to flush the toilet until the specimen is being a valid urine specimen must be being conducted). delivered to the collector. After the forwarded to an HHS-certified (27) The collector must send the split collector has possession of the laboratory for testing. specimens (Bottle A and Bottle B) at the specimen, the donor will be instructed (16) When there is any reason to same time to an HHS-certified to flush the toilet and to participate with believe that a donor may have laboratory or IITF or transfer to a POCT the collector in completing the chain of adulterated or substituted the specimen, tester (if a POCT is being conducted). custody procedures. another specimen must be obtained as (b) If the split specimen bottles and (10) Upon receiving the specimen soon as possible under the direct Federal CCF are not immediately from the donor, the collector must observation of a person of the same prepared for transfer to an HHS-certified determine the volume of urine in the gender and both specimens (i.e., from laboratory or IITF or transferred to a specimen container. the first and second collections) shall be POCT tester, they must be appropriately (i) If the volume is at least 45 mL, the forwarded to an HHS-certified safeguarded until the split specimen collector will proceed with step (11) laboratory for testing. The agency shall bottles and Federal CCF are prepared for below. select the observer if there is no (ii) If the volume is less than 45 mL transfer to an HHS-certified laboratory collector of the same gender available. or IITF. and the temperature is within the (17) Both the donor and the collector acceptable range specified in step (13) must keep the specimen container in Section 8.6 What Are the below, the specimen is discarded and a view at all times. The collector shall Responsibilities of a Federal Agency second specimen must be collected. The request the donor to observe the transfer That Uses a Collection Site? donor may be given a reasonable of the specimen from the collection (a) A Federal agency must ensure that amount of liquid to drink for this container to the two specimen bottles purpose (e.g., an 8 ounce glass of water collectors and collection sites satisfy all and the placement of the tamper-evident requirements in subparts D, E, F, G, and every 30 minutes, but not to exceed a labels/seals on the bottles. maximum of 24 ounces). If the donor H when collecting agency specimens. (18) The collector, in the presence of fails for any reason to provide 30 mL of (b) A Federal agency (or only one the donor, pours the urine into two urine for the second specimen collected, Federal agency when several agencies specimen bottles that are labeled Bottle the collector must contact the are using the same collection site) must A and Bottle B, 30 mL for Bottle A and appropriate authority to obtain guidance conduct an annual inspection of each 15 mL for Bottle B. on the action to be taken. collection site used to collect agency (iii) If the volume is less than 45 mL (19) The Bottle A specimen, specimens. Additionally, a Federal and the temperature is outside the containing a minimum of 30 mL of agency must respond to reports of acceptable range specified in step (13) urine, is to be used for the drug test. If collector and collection site deficiencies below, a second specimen must be there is no additional urine available for reported to them and must take collected using the procedure specified the second specimen bottle (Bottle B), appropriate action to preclude the in step (13) below. the first specimen bottle (Bottle A) shall recurrence of such deficiencies. (11) After the donor has given the nevertheless be processed for testing. Subpart I—HHS Certification of specimen to the collector, the donor (20) A minimum of 15 mL of urine Laboratories and IITFs shall be allowed to wash his or her shall be poured into the second hands. specimen bottle (Bottle B). Section 9.1 What Are the Goals and (12) Immediately after the specimen is (21) The collector must place the Objectives of HHS-Certification? collected, the collector must measure tamper-evident labels/seals on the the temperature of the specimen. The specimen bottles. The collector must (a) Drug testing is an important tool to temperature measuring device used record the date of the collection on the identify drug users in a variety of must accurately reflect the temperature tamper-evident labels/seals. settings. In the proper context, drug of the specimen and not contaminate (22) The donor must initial the testing can be used to deter drug abuse the specimen. The time from urination tamper-evident labels/seals on the split in general. To be a useful tool, all testing ‘‘ to temperature measurement is critical specimen bottles. must satisfy good forensic laboratory and in no case shall exceed 4 minutes. (23) The collector asks the donor to practices’’ and the testing procedures (13) If the temperature of the read and sign a statement on the Federal must be capable of detecting drugs or specimen is outside the range of 32°¥38 CCF certifying that the specimen metabolites at established cutoff °C/90°¥100 °F, that is a reason to identified was collected from him or concentrations. believe that the donor may have her. (b) Reliable discrimination between adulterated or substituted the specimen; (24) Based on a reason to believe that the presence, or absence, of specific another specimen must be collected the donor may adulterate or substitute drugs or their metabolites is critical, not under direct observation of a person of the specimen to be provided, a higher only to achieve the goals of the testing the same gender and both specimens level supervisor must review and program but to protect the rights of the (i.e., from the first and second concur in advance with any decision by Federal employees being tested. Thus, collections) must be forwarded to the a collector to obtain a specimen under standards have been set in order to laboratory for testing. The agency shall direct observation. The person directly achieve maximum accuracy of test select the observer if there is no observing the specimen collection must results. collector of the same gender available. be of the same gender. The agency shall (c) Because of the possible impact of (14) Immediately after the specimen is select the observer if there is no a positive test result on an individual’s collected, the collector shall also inspect collector of the same gender available. livelihood or rights, extra care is the specimen to determine if this is any (25) The collector must sign the required in the handling of the sign indicating that the specimen may Federal CCF. specimen and all other aspects of the not be a valid urine specimen. Any (26) The split specimens and Federal testing procedure. Thus, the testing unusual finding shall be noted on the CCF are now ready for transfer to an procedure must be carefully Federal CCF. HHS-certified laboratory or IITF or documented.

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Section 9.2 Who Has the Authority To (h) Successfully participate in both (4) The concentration of drug or Certify Laboratories and IITFs That the maintenance PT and inspection metabolite is at another concentration Want To Test Specimens for Federal programs (i.e., successfully test the for a special purpose; Agencies? required quarterly sets of maintenance (5) A negative sample will not contain (a) The Secretary has broad discretion PT samples, undergo an inspection 3 a measurable amount of a drug or to take appropriate action to ensure the months after being certified, and metabolite; or full reliability and accuracy of drug undergo maintenance inspections every (6) A PT sample may contain an testing and reporting, to resolve 6 months thereafter); interfering substance or an adulterant or problems related to drug testing, and to (i) Respond in an appropriate, timely, satisfy the criteria for a substituted enforce all standards set forth in these and complete manner to required specimen (as appropriate). Guidelines. The Secretary has the corrective action in the event of failure (b) For each PT cycle, the set of PT authority to issue directives to any in either the maintenance PT or samples going to each laboratory or IITF laboratory or IITF suspending the use of inspection program for which will vary but, within each calendar year, certain analytical procedures when suspension and/or revocation are each laboratory or IITF will analyze necessary to protect the integrity of the proposed by the Secretary; essentially the same total set of samples. testing process; ordering any laboratory (j) Satisfactorily complete a special (c) The laboratory or IITF must, to the or IITF to undertake corrective actions inspection and corrective remedial greatest extent possible, handle, test, to respond to material deficiencies action to maintain or restore and report a PT sample in a manner identified by an inspection or through certification when material deficiencies identical to that used for a donor performance testing; ordering any occur in either the PT program, specimen, unless otherwise specified. inspection program, or in operations laboratory or IITF to send specimens or Section 9.6 What Are the PT and reporting; specimen aliquots to another laboratory Requirements for an Applicant (k) Stop testing Federal agency for retesting when necessary to ensure Laboratory To Conduct Hair Testing? the accuracy of testing under these specimens should PT, maintenance Guidelines; ordering the review of inspection, special inspection, or other (a) An applicant laboratory that seeks results for specimens tested under the material deficiencies indicate that there certification to conduct hair testing Guidelines for private sector clients to is an imminent harm to the government must satisfy the following criteria on 3 the extent necessary to ensure the full and its employees requiring that consecutive sets of PT samples: reliability of drug testing for Federal immediate suspension and revocation (1) Have no false positive results; agencies; and ordering any other action procedures be imposed by the Secretary; (2) Correctly identify and confirm at necessary to address deficiencies in and least 90 percent of the total drug drug testing, analysis, specimen (l) Follow the HHS procedures in challenges on the 3 sets of PT samples; (3) Correctly determine the collection, chain of custody, reporting of subpart Q that will be used for all quantitative values for at least 80 results, or any other aspect of the actions associated with the suspension and/or revocation of HHS-certification percent of the total drug challenges to be certification program. ± ± (b) A laboratory or IITF is prohibited for each type of specimen and type of within 20 percent or 2 standard from stating or implying that it is certification held. deviations of the calculated reference certified by HHS under these Guidelines group mean; Section 9.4 How Does a Laboratory or (4) Have no quantitative value on a to test a particular specimen unless it IITF Apply To Become HHS-Certified? holds such certification for each type of drug concentration that differs by more specimen it wants to test for Federal (a) A laboratory or IITF interested in than 50 percent from the calculated agencies. becoming HHS-certified must submit an reference group mean; and OMB-approved application form. (5) For an individual drug, must Section 9.3 What Is the Process for a (b) The application form requires the correctly detect and quantify at least 50 Laboratory or IITF To Become HHS- applicant laboratory or IITF to provide percent of the total drug challenges. Certified and To Maintain That detailed information on both the (6) Must not obtain any quantitative Certification? administrative and analytical value on a validity test sample that ± A laboratory or IITF that wants to procedures the laboratory or IITF differs by more than 50 percent from become an HHS-certified laboratory or proposes to use for testing Federal the calculated reference group means; IITF must: agency specimens after it is certified. (7) For qualitative validity test samples, must correctly report at least (a) Read and understand these Section 9.5 What Are the Qualitative Guidelines; 80 percent of the challenges for each and Quantitative Specifications of a qualitative validity test sample over the (b) Request an OMB-approved Performance Test (PT) Sample? application; 3 sets of PT samples; and (c) Submit a completed application (a) A PT sample must satisfy one of (8) Must not report any sample as for each type of specimen and type of the following criteria: adulterated with a compound that is not certification applied for; (1) Contains one or more of the drugs present in the sample. (d) Have its application reviewed as and metabolites in the drug classes (b) Failure to achieve any one of the complete and accepted by HHS; listed in sections 3.4, 3.5, 3.6, and 3.7. requirements will result in (e) Successfully complete the PT (2) The concentration of a drug or disqualification. challenges in 3 consecutive sets of metabolite is at least 20 percent above Section 9.7 What Are the PT initial PT samples as required for each the cutoff concentration for either the Requirements for an Applicant type of specimen for which certification initial drug test or the confirmatory drug Laboratory To Conduct Oral Fluid is applied for; test depending on which is to be (f) Satisfy all the requirements for an evaluated; Testing? initial inspection; (3) The concentration of a drug or (a) An applicant laboratory that seeks (g) Receive a letter of certification metabolite is as low as 40 percent of the certification to conduct oral fluid testing from the Secretary before being able to cutoff concentration when the PT must satisfy the following criteria on 3 test specimens for Federal agencies; sample is designated as a retest sample; consecutive sets of PT samples:

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(1) Have no false positive results; (8) Must not report any sample as on pH when the calculated group (2) Correctly identify and confirm at adulterated with a compound that is not reference mean is within the acceptable least 90 percent of the total drug present in the sample. pH range, or substituted when the challenges on the 3 sets of PT samples; (b) Failure to achieve any one of the calculated group means for both (3) Correctly determine the requirements will result in creatinine and specific gravity are quantitative values for at least 80 disqualification. within the acceptable range. percent of the total drug challenges to be (b) Failure to achieve any one of the ± ± Section 9.9 What Are the PT within 20 percent or 2 standard Requirements for an Applicant requirements will result in deviations of the calculated reference Laboratory To Conduct Urine Testing? disqualification. group mean; Section 9.10 What Are the PT (4) Have no quantitative value on a (a) An applicant laboratory that seeks Requirements for an HHS-Certified drug concentration that differs by more certification to conduct urine testing Laboratory To Conduct Hair Testing? than 50 percent from the calculated must satisfy the following criteria on 3 reference group mean; consecutive sets of PT samples: (a) A laboratory certified to conduct (5) For an individual drug, correctly (1) Have no false positive results; hair testing must satisfy the following detect and quantify at least 50 percent (2) Correctly identify and confirm at criteria on the maintenance PT samples of the total drug challenges; least 90 percent of the total drug to maintain its certification: (6) Must not obtain any quantitative challenges on the 3 sets of PT samples; (1) Have no false positive results; (3) Correctly determine the value on a validity test sample that (2) Correctly identify and confirm at quantitative values for at least 80 differs by more than ±50 percent from least 90 percent of the total drug percent of the total drug challenges to be the calculated reference group means; challenges over 2 consecutive PT cycles; within ±20 percent or ±2 standard (7) For qualitative validity test (3) Correctly quantify at least 80 deviations of the calculated reference samples, must correctly report at least percent of the total drug challenges group mean; 80 percent of the challenges for each within ±20 percent or ±2 standard (4) Have no quantitative value on a qualitative validity test sample over the deviations of the appropriate reference drug concentration that differs by more 3 sets of PT samples; and or peer group mean (whichever range is than 50 percent from the calculated (8) Must not report any sample as larger) over 2 consecutive PT cycles; reference group mean; (4) Have no more than one adulterated with a compound that is not (5) For an individual drug, correctly quantitative result that differs by more present in the sample. detect and quantify at least 50 percent than 50 percent from the target value (b) Failure to achieve any one of the of the total drug challenges; requirements will result in (6) Must correctly identify and report over 2 consecutive PT cycles; disqualification. at least 80 percent of the total validity (5) For any individual drug, correctly testing challenges over the 3 sets of PT detect and quantify at least 50 percent Section 9.8 What are the PT of the total drug challenges; Requirements for an Applicant samples; (6) Must not report any validity test Laboratory To Conduct Sweat Patch (7) For each specific validity test, sample as adulterated (that is not Testing? must correctly report at least 80 percent of the challenges for the specific validity adulterated); (a) An applicant laboratory that seeks test over the 3 sets of PT samples; (7) Correctly identify and confirm at certification to conduct sweat patch (8) For quantitative specimen validity least 80 percent of the total validity test testing must satisfy the following tests, must obtain quantitative values for challenges over 2 consecutive PT cycles; criteria on 3 consecutive sets of initial at least 80 percent of the total challenges (8) For quantitative validity tests, PT samples: that satisfy the following criteria: must obtain quantitative values for at (1) Have no false positive results; (i) Nitrite and creatinine least 80 percent of the total challenges; (2) Correctly identify and confirm at concentrations are within ±20 percent or (9) Have no more than one least 90 percent of the total drug ±2 standard deviations of the calculated quantitative value on a validity test challenges on the 3 sets of PT samples; reference group mean; sample that differs by more than ±50 (3) Correctly determine the (ii) pH values are within ±0.3 pH percent from the calculated reference quantitative values for at least 80 units of the calculated reference group group means; and percent of the total drug challenges to be mean; and (10) For each qualitative specimen within ±20 percent or ±2 standard (iii) Specific gravity values are within validity test, must correctly report at deviations of the calculated reference ±0.0003 specific gravity units of the least 80 percent of the challenges for group mean; calculated reference group mean; each qualitative specimen validity test (4) Have no quantitative value on a (9) Must not obtain any quantitative over 2 consecutive PT cycles. drug concentration that differs by more value on a specimen validity testing (b) Failure to participate in a PT cycle than 50 percent from the calculated sample that differs by more than ±50 or to participate satisfactorily may result reference group mean; and percent for nitrite and creatinine in suspension or revocation of an HHS- (5) For an individual drug, correctly concentrations, ±0.8 units for pH certified laboratory’s certification for detect and quantify at least 50 percent measurements, or ±0.0006 units for hair testing. of the total drug challenges. specific gravity from the calculated Section 9.11 What Are the PT (6) Must not obtain any quantitative reference group means; Requirements for an HHS-Certified value on a validity test sample that (10) For qualitative specimen validity Laboratory To Conduct Oral Fluid differs by more than ±50 percent from tests, must correctly report at least 80 Testing? the calculated reference group means; percent of the challenges for each (7) For qualitative validity test qualitative specimen validity test over (a) A laboratory certified to conduct samples, must correctly report at least the 3 sets of PT samples; and oral fluid testing must satisfy the 80 percent of the challenges for each (11) Must not report any sample as following criteria on the maintenance qualitative validity test sample over the adulterated with a compound that is not PT samples to maintain its certification: 3 sets of PT samples; and present in the sample, adulterated based (1) Have no false positive results;

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(2) Correctly identify and confirm at (7) Correctly identify and confirm at sample that differs by more than ±50 least 90 percent of the total drug least 80 percent of the total validity test percent for nitrite and creatinine challenges over 2 consecutive PT cycles; challenges over 2 consecutive PT cycles; concentrations, ±0.8 unit for pH (3) Correctly quantify at least 80 (8) For quantitative validity tests, measurements, or ±0.0006 units for percent of the total drug challenges must obtain quantitative values for at specific gravity from the calculated within ±20 percent or ±2 standard least 80 percent of the total challenges; reference group means; and deviations of the appropriate reference (9) Have no more than one (10) For each qualitative specimen or peer group mean (whichever range is quantitative value on a validity test validity test, must correctly report at larger) over 2 consecutive PT cycles; sample that differs by more than ±50 least 80 percent of the challenges for (4) Have no more than one percent from the calculated reference each qualitative validity test over 2 quantitative result that differs by more group means; and consecutive PT cycles. than 50 percent from the target value (10) For each qualitative specimen (b) Failure to participate in a PT cycle over 2 consecutive PT cycles; validity test, must correctly report at or to participate satisfactorily may result (5) For any individual drug, correctly least 80 percent of the challenges for in suspension or revocation of an HHS- detect and quantify at least 50 percent each qualitative specimen validity test certified laboratory’s certification for of the total drug challenges; over 2 consecutive PT cycles. urine testing. (6) Must not report any validity test (b) Failure to participate in a PT cycle sample as adulterated (that is not or to participate satisfactorily may result Section 9.14 What Are the PT adulterated); in suspension or revocation of an HHS- Requirements for an Applicant IITF To (7) Correctly identify and confirm at certified laboratory’s certification for Conduct Hair Testing? least 80 percent of the total validity test sweat patch testing. (a) An applicant IITF that seeks challenges over 2 consecutive PT cycles; Section 9.13 What Are the PT certification to conduct hair testing (8) For quantitative validity tests, Requirements for an HHS-Certified must satisfy the following criteria on 3 must obtain quantitative values for at Laboratory To Conduct Urine Testing? consecutive sets of PT samples: least 80 percent of the total challenges; (1) Correctly identify and report at (9) Have no more than one (a) A laboratory certified to conduct least 80 percent of the total drug quantitative value on a validity test urine testing must satisfy the following challenges using its initial drug tests sample that differs by more than ±50 criteria on the maintenance PT samples over 3 sets of PT samples; percent from the calculated reference to maintain its certification: (2) Correctly identify and report at (1) Have no false positive results; least 80 percent of the total validity test group means; and (2) Correctly identify and confirm at (10) For each qualitative specimen challenges using its initial validity tests least 90 percent of the total drug validity test, must correctly report at challenges over 2 consecutive PT cycles; over 3 sets of PT samples; least 80 percent of the challenges for (3) Correctly quantify at least 80 (3) For each specific drug test, must each qualitative specimen validity test percent of the total drug challenges correctly identify and report at least 50 over 2 consecutive PT cycles. within ±20 percent or ±2 standard percent of the drug challenges for a (b) Failure to participate in a PT cycle deviations of the appropriate reference specific drug test over 3 sets of PT or to participate satisfactorily may result or peer group mean (whichever range is samples; and in suspension or revocation of an HHS- larger) as measured over 2 consecutive (4) For each specific validity test, certified laboratory’s certification for PT cycles; must correctly identify and report at oral fluid testing. (4) Have no more than one least 50 percent of the challenges for a specific validity test over 3 sets of PT Section 9.12 What Are the PT quantitative result that differs by more samples. Requirements for an HHS-Certified than 50 percent from the target value over 2 consecutive PT cycles; (b) Failure to achieve any one of the Laboratory To Conduct Sweat Patch requirements will result in Testing? (5) For any individual drug, correctly detect and quantify at least 50 percent disqualification. (a) A laboratory certified to conduct of the total drug challenges; Section 9.15 What Are the PT sweat patch testing must satisfy the (6) Must not report any validity test following criteria on the maintenance Requirements for an Applicant IITF To sample as adulterated (that is not Conduct Oral Fluid Testing? PT samples to maintain its certification: adulterated) or substituted (that is not (1) Have no false positive results; substituted); (a) An applicant IITF that seeks (2) Correctly identify and confirm at (7) Correctly identify and confirm at certification to conduct oral fluid testing least 90 percent of the total drug least 80 percent of the total validity test must satisfy the following criteria on 3 challenges over 2 consecutive PT cycles; challenges over 2 consecutive PT cycles; consecutive sets of PT samples: (3) Correctly quantify at least 80 (8) For quantitative specimen validity (1) Correctly identify and report at percent of the total drug challenges tests, must obtain quantitative values for least 80 percent of the total drug within ±20 percent or ±2 standard at least 80 percent of the total challenges challenges using its initial drug tests deviations of the appropriate reference that satisfy the following criteria: over 3 sets of PT samples; or peer group mean (whichever range is (i) Nitrite and creatinine (2) Correctly identify and report at larger) over 2 consecutive PT cycles; concentrations are within ±20 percent or least 80 percent of the total validity test (4) Have no more than one ±2 standard deviations of the calculated challenges using its initial validity tests quantitative result that differs by more reference group mean; over 3 sets of PT samples; than 50 percent from the target value (ii) pH values are within ±0.3 pH (3) For each specific drug test, must over 2 consecutive PT cycles; units of the calculated reference group correctly identify and report at least 50 (5) For any individual drug, correctly mean; and percent of the drug challenges for a detect and quantify at least 50 percent (iii) Specific gravity values are within specific initial drug test over 3 sets of of the total drug challenges; ±0.0003 specific gravity units of the PT samples; and (6) Must not report any validity test calculated reference group mean; (4) For each specific validity test, sample as adulterated (that is not (9) No more than one quantitative must correctly identify and report at adulterated); value on a specimen validity testing least 50 percent of the challenges for a

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specific initial validity test over 3 sets (ii) pH values are within ±0.3 pH (3) For each specific drug test, must of PT samples. units of the calculated reference group correctly identify and report at least 50 (b) Failure to achieve any one of the mean; and percent of the drug challenges for a requirements will result in (iii) Specific gravity values are within specific initial drug test over 2 disqualification. ±0.0003 specific gravity units of the consecutive PT cycles; and Section 9.16 What Are the PT calculated reference group mean; (4) For each specific validity test, (6) Must not obtain any quantitative Requirements for an Applicant IITF To must correctly identify and report at value on an initial validity test sample Conduct Sweat Patch Testing? least 50 percent of the challenges for a that differs by more than ±50 percent for specific initial validity test over 2 (a) An applicant IITF that seeks nitrite and creatinine concentrations, consecutive PT cycles. certification to conduct sweat patch ±0.8 units for pH measurements, or (b) Failure to satisfy the standards testing must satisfy the following ±0.0006 units for specific gravity from may result in suspension or proposed criteria on 3 consecutive sets of PT the calculated reference group means; revocation of an HHS-certified IITF’s samples: and certification for oral fluid testing. (1) Correctly identify and report at (7) For qualitative initial validity Section 9.20 What Are the PT least 80 percent of the total drug tests, must correctly identify and report Requirements for an HHS-Certified IITF challenges using its initial drug tests at least 80 percent of the challenges for To Conduct Sweat Patch Testing? over 3 sets of PT samples; each qualitative initial validity test over (2) Correctly identify and report at 3 sets of PT samples. (a) An HHS-certified IITF must satisfy least 80 percent of the total validity test (b) Failure to achieve any one of the the following criteria on the challenges using its initial validity tests requirements will result in maintenance PT samples to maintain its over 3 sets of PT samples; disqualification. certification to conduct sweat patch (3) For each specific drug test, must testing: correctly identify and report at least 50 Section 9.18 What Are the PT (1) Correctly identify and report at percent of the drug challenges for a Requirements for an HHS-Certified IITF least 80 percent of the total initial drug specific initial drug test over 3 sets of To Conduct Hair Testing? test challenges as measured over 2 PT samples; and (a) An HHS-certified IITF must satisfy consecutive PT cycles; (4) For each specific validity test, the following criteria on the (2) Correctly identify and report at must correctly identify and report at maintenance PT samples to maintain its least 80 percent of the initial validity least 50 percent of the challenges for a certification to conduct hair testing: test challenges over 2 consecutive PT specific initial validity test over 3 sets (1) Correctly identify and report at cycles; of PT samples. least 80 percent of the total initial drug (3) For each specific drug test, must (b) Failure to achieve any one of the test challenges as measured over 2 correctly identify and report at least 50 requirements will result in consecutive PT cycles; percent of the drug challenges for a disqualification. (2) Correctly identify and report at specific initial drug test over 2 Section 9.17 What Are the PT least 80 percent of the initial validity consecutive PT cycles; and Requirements for an Applicant IITF To test challenges over 2 consecutive PT (4) For each specific validity test, Conduct Urine Testing? cycles; must correctly identify and report at (a) An applicant IITF that seeks (3) For each specific drug test, must least 50 percent of the challenges for a certification to conduct urine testing correctly identify and report at least 50 specific initial validity test over 2 must satisfy the following criteria on 3 percent of the drug challenges for a consecutive PT cycles. consecutive sets of PT samples: specific initial drug test over 2 (b) Failure to satisfy the standards (1) Correctly identify and report at consecutive PT cycles; and may result in suspension or proposed least 80 percent of the total drug (4) For each specific validity test, revocation of an HHS-certified IITF’s challenges using its initial drug tests must correctly identify and report at certification for sweat patch testing. least 50 percent of the challenges for a over 3 sets of PT samples; Section 9.21 What Are the PT specific initial validity test over 2 (2) Correctly identify and report at Requirements for an HHS-Certified IITF consecutive PT cycles. least 80 percent of the total validity test to Conduct Urine Testing? challenges using its initial validity tests (b) Failure to satisfy the standards over 3 sets of PT samples; may result in suspension or proposed (a) An HHS-certified IITF must satisfy (3) For each specific drug test, must revocation of an HHS-certified IITF’s the following criteria on the correctly identify and report at least 50 certification for hair testing. maintenance PT samples to maintain its certification to conduct urine testing: percent of the drug challenges for a Section 9.19 What Are the PT specific initial drug test over 3 sets of (1) Correctly identify and report at Requirements for an HHS-Certified IITF least 80 percent of the total initial drug PT samples; To Conduct Oral Fluid Testing? (4) For each specific validity test, test challenges as measured over 2 must correctly identify and report at (a) An HHS-certified IITF must satisfy consecutive PT cycles; least 50 percent of the challenges for a the following criteria on the (2) Correctly identify and report at specific initial validity test over 3 sets maintenance PT samples to maintain its least 80 percent of the initial validity of PT samples; certification to conduct oral fluid test challenges over 2 consecutive PT (5) For quantitative specimen validity testing: cycles; tests, must obtain quantitative values for (1) Correctly identify and report at (3) For each specific drug test, must at least 80 percent of the total initial least 80 percent of the total initial drug correctly identify and report at least 50 validity test challenges that satisfy the test challenges as measured over 2 percent of the drug challenges for a following criteria: consecutive PT cycles; specific initial drug test over 2 (i) Nitrite and creatinine (2) Correctly identify and report at consecutive PT cycles; concentrations are within ±20 percent or least 80 percent of the initial validity (4) For each specific validity test, ±2 standard deviations of the calculated test challenges over 2 consecutive PT must correctly identify and report at reference group mean; cycles; least 50 percent of the challenges for a

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specific initial validity test over 2 Section 9.23 What Are the Section 9.26 What Happens if an HHS- consecutive PT cycles; Maintenance Inspection Requirements Certified Laboratory or IITF Does Not (5) For quantitative validity tests, for an HHS-Certified Laboratory or IITF? Satisfy the Minimum Requirements for Either the PT Program or the Inspection must obtain quantitative values for at (a) An HHS-certified laboratory or Program? least 80 percent of the total initial IITF must undergo an inspection 3 validity test challenges that satisfy the months after becoming certified and (a) If an HHS-certified laboratory or following criteria: then an inspection every 6 months IITF fails to satisfy the minimum (i) Nitrite and creatinine thereafter. requirements for certification, the concentrations are within ±20 percent or (b) An HHS-certified laboratory or laboratory or IITF is given a period of ±2 standard deviations of the calculated IITF is inspected by one or more time (e.g., 5 or 30 working days reference group mean; inspectors. The number of inspectors depending on the nature of the issue) to (ii) pH values are within ±0.3 pH required is dependent on the workload provide any explanation for its units of the calculated reference group of the laboratory or IITF. performance and evidence that any mean; and (c) Each inspector conducts an deficiency has been corrected. (iii) Specific gravity values are within independent evaluation and review of (b) A laboratory’s or IITF’s ±0.0003 specific gravity units of the the HHS-certified laboratory’s or IITF’s certification may be revoked, calculated reference group mean; procedures for each type of specimen suspended, or no further action taken (6) Must not obtain any quantitative and facilities using guidance provided depending on the seriousness of the value on an initial validity test sample by the Secretary. errors and whether there is evidence that differs by more than ±50 percent for (d) To remain certified, an HHS- that any deficiency has been corrected nitrite and creatinine concentrations, certified laboratory or IITF must and that current performance meets the ±0.8 units for pH measurements, or continue to satisfy the minimum requirements for a certified laboratory or ±0.0006 units for specific gravity from requirements as stated in these IITF. the calculated reference group means; Guidelines for that type of specimen. (c) An HHS-certified laboratory or and IITF may be required to undergo a Section 9.24 Who Can Inspect an special inspection or to test additional (7) For qualitative validity tests, must HHS-Certified Laboratory or IITF and PT samples, depending on the nature of correctly identify and report at least 80 When May the Inspection Be the performance, to verify that any percent of the challenges for each Conducted? deficiency has been corrected. qualitative initial validity test over 2 consecutive PT cycles. (a) The Secretary or a Federal agency (d) If an HHS-certified laboratory’s or may conduct an inspection at any time. IITF’s certification is revoked or (b) Failure to satisfy the standards (b) An individual may serve as an suspended in accordance with the may result in suspension or proposed inspector for the Secretary if he or she process described in subpart Q, the revocation of an HHS-certified IITF’s satisfies the following criteria: laboratory or IITF is not permitted to certification for urine testing. (1) Has experience and an educational test specimens for Federal agencies until Section 9.22 What Are the Inspection background similar to that required for the suspension is lifted or the laboratory Requirements for an Applicant either the responsible person or the or IITF has successfully completed the Laboratory or IITF? certifying scientist as described in certification requirements as a new subpart K for a laboratory or as a applicant laboratory or IITF. (a) An applicant laboratory or IITF is responsible technician as described in inspected by a team of at least two Section 9.27 What Factors Are subpart M; inspectors. Considered in Determining Whether (2) Has read and thoroughly (b) Each inspector conducts an Revocation of a Laboratory’s or IITF’s understands the policies and Certification Is Necessary? independent review and evaluation of requirements contained in these all aspects of the laboratory’s or IITF’s Guidelines and in other guidance (a) The Secretary shall revoke testing procedures and facilities using consistent with these Guidelines certification of any laboratory or IITF an inspection checklist. provided by the Secretary; certified in accordance with these (c) To become certified, an applicant (3) Submits a resume and Guidelines if the Secretary determines laboratory or IITF must satisfy the documentation of qualifications to HHS; that revocation is necessary to ensure minimum requirements as stated in (4) Attends approved training; and the full reliability and accuracy of drug these Guidelines. (5) Submits an acceptable inspection and validity tests and the accurate (d) An applicant laboratory or IITF report and performs acceptably as a reporting of test results. must be separately inspected for each trainee inspector on an inspection. (b) The Secretary shall consider the type of specimen for which it has following factors in determining applied. The inspection for each type of Section 9.25 What Happens if an whether revocation is necessary: specimen may be conducted Applicant Laboratory or IITF Does Not (1) Unsatisfactory performance in concurrently, but the inspectors must Satisfy the Minimum Requirements for analyzing and reporting the results of review all appropriate data in distinct Either the PT Program or the Inspection drug and validity tests; for example, a audits. Program? false positive error in reporting the (e) An applicant laboratory or IITF If an applicant laboratory or IITF fails results of an employee’s drug test; that applies for certification to conduct to satisfy the requirements established (2) Unsatisfactory participation in testing of different types of specimens, for the initial certification process, the performance evaluations or inspections; but does not satisfy the minimum applicant laboratory must start the (3) A material violation of a requirements for each type of specimen, initial certification process from the certification standard or a contract term may be certified for those types of beginning for the type of specimen for or other condition imposed on the specimens for which it has satisfied the which they were applying to become laboratory or IITF by a Federal agency minimum requirements. certified. using the laboratory’s or IITF’s services;

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(4) Conviction for any criminal (c) A suspension must be effective program, the agency must submit at offense committed as an incident to immediately. A proposed revocation least three percent blind samples along operation of the laboratory or IITF; or must be effective 30 days after written with its donor specimens. (5) Any other cause that materially notice is given or, if review is requested, (c) After the initial 90-day period, the affects the ability of the laboratory or upon the reviewing official’s decision to agency must submit one percent blind IITF to ensure the full reliability and uphold the proposed revocation. If the samples along with its donor specimens accuracy of drug and validity tests and reviewing official decides not to uphold based on the projected total number of the accurate reporting of results. the suspension or proposed revocation, specimens that will be collected per (c) The period and terms of revocation the suspension must terminate year. Every effort should be made to shall be determined by the Secretary immediately and any proposed ensure that some of the blind samples and shall depend upon the facts and revocation shall not take effect. are submitted quarterly. circumstances of the revocation and the (d) The Secretary will publish in the (d) Of the blind samples submitted, need to ensure accurate and reliable Federal Register the name, address, and approximately 80 percent of the blind drug and validity testing of Federal telephone number of any laboratory or samples must be negative and 20 employees. IITF that has its certification revoked or percent non-negative. Section 9.28 What Factors Are suspended under section 9.27 or section 9.28, respectively, and the name of any Section 10.2 What Are the Considered in Determining Whether To Requirements for a Blind Sample? Suspend a Laboratory or IITF? laboratory or IITF that has its suspension lifted. The Secretary shall (a) A blind sample that is drug (a) Whenever the Secretary has reason provide to any member of the public positive must be validated by the to believe that revocation may be upon request the written notice supplier as to its content using required and that immediate action is provided to a laboratory or IITF that has appropriate initial and confirmatory necessary in order to protect the its certification suspended or revoked, tests. interests of the United States and its as well as the reviewing official’s (b) A blind sample that is negative employees, the Secretary may written decision which upholds or (i.e., certified to contain no drug) must immediately suspend (either partially or denies the suspension or proposed be validated by the supplier as negative fully) a laboratory’s or IITF’s revocation under the procedures of using appropriate initial and certification to conduct drug and subpart Q. confirmatory tests. validity testing for Federal agencies. (c) The supplier must provide (b) The period and terms of Section 9.30 May a Laboratory or IITF information regarding the shelf life of suspension shall be determined by the That Had Its Certification Revoked Be the blind sample. Secretary and shall depend upon the Recertified To Test Federal Agency (d) For a blind sample that is drug facts and circumstances of the Specimens? positive, the concentration of the drug it suspension and the need to ensure Following revocation, a laboratory or contains should be between 1.5 and 2 accurate and reliable drug and validity IITF may apply for recertification. times the initial drug test cutoff testing of Federal employees. Unless otherwise provided by the concentration and must be spiked or Section 9.29 How Does the Secretary Secretary in the notice of revocation contain one or more of the drugs or Notify a Laboratory or IITF That Action under section 9.29(a) or the reviewing metabolites listed in sections 3.3, 3.4, Is Being Taken Against the Laboratory official’s decision under section 17.9(e) 3.5, and 3.6. or IITF? or 17.14(a), a laboratory or IITF which (e) For hair, oral fluid, sweat patch, has had its certification revoked may (a) When a laboratory or IITF is and urine, a blind sample that is reapply for certification as an applicant adulterated must have the suspended or the Secretary seeks to laboratory or IITF. revoke certification, the Secretary shall characteristics to clearly show that it is immediately serve the laboratory or IITF Section 9.31 Where Is the List of HHS- an adulterated sample at the time it is with written notice of the suspension or Certified Laboratories or IITFs validated by the supplier. proposed revocation by facsimile mail, Published? (f) For oral fluid and urine, a blind personal service, or registered or sample that is substituted must have the (a) The list of HHS-certified characteristics to clearly show that it is certified mail, return receipt requested. laboratories and IITFs and the type of This notice shall state the following: a substituted sample at the time it is specimen for which each is certified is validated by the supplier. (1) The reasons for the suspension or published monthly in the Federal proposed revocation; Register. Section 10.3 How Is a Blind Sample (2) The terms of the suspension or (b) An applicant laboratory or IITF is Submitted to an HHS-Certified proposed revocation; and not included on the list. Laboratory or IITF? (3) The period of suspension or proposed revocation. Subpart J—Blind Samples Submitted by (a) A blind sample is submitted using (b) The written notice shall state that an Agency the same Federal CCF as used for a the laboratory or IITF will be afforded donor specimen. The collector provides an opportunity for an informal review of Section 10.1 What Are the the required information to ensure that the suspension or proposed revocation Requirements for Federal Agencies To the Federal CCF has been properly if it so requests in writing within 30 Submit Blind Samples to HHS-Certified completed as well as providing days of the date the laboratory or IITF Laboratories or IITFs? fictitious initials on the specimen label/ received the notice, or if expedited (a) Each Federal agency is required to seal. The collector must indicate that review is requested, within 3 days of the have both negative and non-negative the sample is a blind sample on the date the laboratory or IITF received the blind samples for each type of donor MRO copy where a donor would notice. Subpart Q contains detailed specimen being submitted to an HHS- normally provide a signature. procedures to be followed for an certified laboratory or IITF. (b) A collector must distribute the informal review of the suspension or (b) During the initial 90-day period of required number of blind samples proposed revocation. a new Federal agency drug testing throughout the total number of donor

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specimens rather than submitting them (8) Reporting procedures; and Section 11.3 What Scientific as a single group of samples. (9) Computers, software, laboratory Qualifications in Analytical Toxicology information management systems. Must the RP Have? Section 10.4 What Happens if an Inconsistent Result Is Reported on a (c) All procedures in the SOP manual The RP must have documented Blind Sample? must be in compliance with these scientific qualifications in analytical Guidelines and other guidance provided toxicology. If an HHS-certified laboratory reports by the Secretary. Minimum qualifications are: an inconsistent result on a blind sample (d) A copy of all procedures that have (a) Be certified as a laboratory director (e.g., a laboratory reports a negative been replaced or revised and the dates by the State in forensic or clinical result on a blind sample that was on which they were in effect must be laboratory toxicology; have a Ph.D. in supposed to be positive, a laboratory maintained for 2 years to allow the one of the natural sciences or have reports a positive result on a blind laboratory to retrieve the procedures training and experience comparable to a sample that was supposed to be that were used to test a specimen. Ph.D. in one of the natural sciences with negative, an IITF reports a negative training and laboratory/research result on a blind sample that was Section 11.2 What Are the experience in biology, chemistry, and supposed to be positive, a laboratory or Responsibilities of the Responsible pharmacology or toxicology; IITF cannot obtain a valid drug test Person (RP)? (b) Have experience in forensic result): (a) Manage the day-to-day operations toxicology with emphasis on the (a) The MRO must contact supplier of of the drug testing laboratory even collection and analysis of biological the blind sample and attempt to where another individual has overall specimens for drugs of abuse; determine if the supplier made a responsibility for an entire multi- (c) Have experience in forensic mistake when preparing the blind specialty laboratory. applications of analytical toxicology sample; (b) Ensure that there are enough (e.g., publications, court testimony, (b) The MRO must contact the personnel with adequate training and conducting research on the toxicology of collector and determine if the collector experience to supervise and conduct the drugs of abuse) or qualify as an expert made an error when preparing the blind work of the drug testing laboratory. The witness in forensic toxicology; and sample for shipment to the laboratory; RP must ensure the continued (d) Be found to fulfill RP (c) If there is no obvious reason for the competency of laboratory personnel by responsibilities and qualifications upon inconsistent result, the MRO must documenting their in-service training, interview by HHS-trained inspectors notify both the Federal agency for which reviewing their work performance, and during each on-site inspection of the the blind sample was submitted and the verifying their skills. laboratory. Secretary; and (c) Maintain a complete, current SOP Section 11.4 What Happens When the (d) The Secretary shall investigate the manual that is available for personnel in RP Is Absent or Leaves an HHS-Certified blind sample error. A report of the the drug testing laboratory, and Laboratory? Secretary’s investigative findings and followed by those personnel. The SOP the corrective action taken by the HHS- (a) All HHS-certified laboratories manual must be reviewed, signed, and must have multiple RPs or an alternate certified laboratory or IITF must be sent dated by the RP(s) whenever procedures to the Federal agency. The Secretary RP. Extremely small certified are first placed into use or changed or laboratories may request a waiver from shall ensure notification of the finding when a new individual assumes to all other Federal agencies for which the Secretary to this requirement under responsibility for management of the special circumstance. An alternate RP the laboratory or IITF is engaged in drug drug testing laboratory. testing and coordinate any necessary must be able to fulfill the (d) Maintain a quality assurance responsibilities of an RP, and must meet action to prevent the recurrence of the program to assure the proper error. the qualifications of a certifying performance and reporting of all test scientist. The laboratory must submit Subpart K—Laboratory results; verify and monitor acceptable documentation satisfactory to the analytical performance for all controls Secretary which shows the credentials Section 11.1 What Is a Standard and standards; monitor quality control Operating Procedure Manual? of the prospective RP and which must testing; document the validity, be approved by the Secretary, and found (a) An HHS-certified laboratory must reliability, accuracy, precision, and acceptable during on-site inspections of have a standard operating procedure performance characteristics of each test the laboratory. (SOP) manual that describes, in detail, and test system. (b) When an HHS-certified laboratory all laboratory operations. When (e) Implement all remedial actions is without the RP and alternate RP for followed, it ensures that all specimens necessary to maintain satisfactory 14 calendar days or less (e.g., vacation, are tested using the same procedures operation and performance of the illness, business trip), the certified and in a consistent manner. laboratory in response to quality control laboratory may continue testing Federal (b) The SOP manual must include, but systems not being within performance agency specimens under the direction of is not limited to, a detailed description specifications, errors in result reporting a certifying scientist. of the following: or in analysis of performance testing (c) When an RP permanently leaves (1) Chain-of-custody procedures; results, and deficiencies identified an HHS-certified laboratory: (2) Accessioning; during inspections. This individual (1) An HHS-certified laboratory may (3) Security; must ensure that sample results are not maintain its certification and continue (4) Quality control/quality assurance reported until all corrective actions have testing Federal agency specimens under programs; been taken and he or she can assure that the direction of an alternate RP for a (5) Analytical methods and the results provided are accurate and period of up to 180 days while seeking procedures; reliable. to hire and receive the Secretary’s (6) Equipment and maintenance (f) Qualify as a certifying scientist for approval of the new permanent RP. programs; positive, adulterated, and substituted (2) The Secretary, in accordance with (7) Personnel training; test results. these Guidelines, will suspend a

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laboratory’s certification for all permitted to work independently with Section 11.11 What Test(s) Does an specimens if the laboratory does not regulated specimens. HHS-Certified Laboratory Conduct on a have a permanent RP within 180 days. Specimen Received From an IITF? Section 11.7 What Security Measures The suspension will be lifted upon the Must an HHS-Certified Laboratory An HHS-certified laboratory conducts Secretary’s approval of the new Maintain? the confirmatory test(s) for the non- permanent RP. (d) When a new RP candidate has (a) An HHS-certified laboratory must negative result(s) identified by the IITF. been identified, the laboratory must control access to the drug testing Section 11.12 What Are the submit to the Secretary the candidate’s facility, specimens, aliquots, and Requirements for an Initial Drug Test? current resume or curriculum vitae, records. (a) An initial drug test must be an arrange to have official academic (b) Authorized visitors must be immunoassay test or a test that transcript(s) submitted by the escorted at all times, except for combines a chromatographic separation candidate’s institution(s) of higher individuals conducting inspections (i.e., coupled with an appropriate detector. learning, copies of diplomas and any for the Department, a Federal agency, a licensures, a training plan (not to exceed state, or other accrediting agency) or (b) A laboratory must validate an 90 days) to transition into the RP emergency personnel (such as, initial drug test before using it to test position, and an itemized defense of the firefighters and medical rescue teams). specimens. candidate’s qualifications compared to (c) A laboratory must maintain a (c) Initial drug test kits must meet the the minimum RP qualifications record that documents the dates, time of FDA requirements for commercial described in the Guidelines. entry and exit, and purpose of entry of distribution. (e) The laboratory must fulfill other authorized escorted visitors accessing (d) A laboratory may conduct a inspection and PT criteria as required secured areas. second initial drug test on a specimen prior to conducting Federal agency prior to the confirmatory drug test. If the testing under a new RP. Section 11.8 What Are the Internal laboratory uses a second initial drug Laboratory Chain of Custody Section 11.5 What Qualifications Must test, the second initial drug test is Requirements for a Specimen or an subject to the same requirements as the an Individual Have To Certify a Result Aliquot? Reported By an HHS-Certified first initial drug test. Laboratory? (a) An HHS-certified laboratory must Section 11.13 What Must an HHS- use chain of custody procedures to (a) The individual (i.e., the certifying Certified Laboratory Do To Validate an maintain control and accountability of Initial Drug Test? scientist) who certifies a non-negative or specimens from receipt through invalid result test result must have: completion of testing, reporting of (a) The laboratory must demonstrate (1) A bachelor’s degree in the results, during storage, and continuing and document for each initial test: chemical or biological sciences, medical until final disposition of the specimens. (1) The ability to differentiate positive technology, or similar field; (b) An HHS-certified laboratory must and negative samples; (2) Training and experience in the use chain of custody procedures to analytical methods and procedures used (2) The performance of the test around document the handling and transfer of by the laboratory that are relevant to the the cutoff concentration; and aliquots throughout the testing process results that the individual certifies; and (3) The performance of the test results and until final disposal. (3) Training and experience in at several concentrations between 0 and reviewing and reporting test results, (c) The date and purpose must be 150 percent of the cutoff concentration. maintenance of chain of custody, and documented on an appropriate chain of (b) Performance of new lots must be understanding proper remedial action in custody document each time a specimen verified prior to being placed into response to problems that may arise. or aliquot is handled or transferred, and service. (b) The individual (i.e., the certifying every individual in the chain must be Section 11.14 What Are the Batch technician) who certifies a negative test identified. Quality Control Requirements When result must have: (d) Chain of custody must be Conducting an Initial Drug Test? (1) Training and experience in the maintained and documented by using analytical methods and procedures used either hard copy procedures or (a) Each batch of specimens must by the laboratory that are relevant to the electronic procedures. contain the following QC samples: results that the individual certifies; and (e) Each individual that handles a (1) At least one control certified to (2) Training and experience in specimen or aliquot must sign and contain no drug or metabolite; reviewing and reporting test results, complete the chain of custody (2) At least one positive control with maintenance of chain of custody, and document when the specimen or aliquot the drug or metabolite targeted at 25 understanding proper remedial action in is received. percent above the cutoff; response to problems that may arise. Section 11.9 Which Type of Specimens (3) At least one control with the drug Section 11.6 What Qualifications and May an HHS-Certified Laboratory Test? or metabolite targeted at 75 percent of Training Must Other Laboratory A laboratory must be HHS-certified the cutoff; and Personnel Have? separately for each type of specimen (4) At least one control that appears (a) All laboratory staff (e.g., that it wants to test for a Federal agency. as a donor specimen to the laboratory technicians, administrative staff) must analysts. Section 11.10 What Test(s) Does an have the appropriate training and skills (b) At least 10 percent of the samples HHS-Certified Laboratory Conduct on a for the tasks assigned. in the batch must be calibrators and Specimen Received After a POCT? (b) Each individual working in an controls. HHS-certified laboratory must be An HHS-certified laboratory must test (c) A laboratory must document that properly trained (i.e., receive training in the specimen in the same manner as a any carryover that may occur between each area of work that the individual specimen that had not been previously aliquots during the initial testing will be performing) before he or she is tested. process is detectable and corrected.

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Section 11.15 What Are the Section 11.19 What Are the Analytical Section 11.23 What Are the Requirements for a Confirmatory Drug and Quality Control Requirements for Requirements for Conducting Each Test? Conducting Validity Tests on Oral Fluid Validity Test on an Oral Fluid (a) The analytical method used must Specimens? Specimen? combine chromatographic separation (a) Each validity test result must be (a) The initial test for a specific and mass spectrometric identification based on performing an initial validity validity test must use a different (e.g., GC/MS, liquid chromatography/ test on one aliquot and a confirmatory analytical principle or chemical reaction mass spectrometry (LC/MS), GC/MS/ than that used for the confirmatory test; validity test on a second aliquot; and MS, LC/MS/MS). (b) Each initial and confirmatory (b) A confirmatory drug test must be (b) Each analytical run of specimens validity test that is quantitative must validated before the laboratory can use for which an initial or confirmatory include an appropriate calibrator, a it to test specimens. validity test is being performed must control without the compound of Section 11.16 What Must an HHS- include the appropriate calibrators and interest (i.e., a certified negative Certified Laboratory Do To Validate a controls. control), and a control with the Confirmatory Drug Test Method? Section 11.20 What Are the Analytical compound of interest at a measurable concentration; and An HHS-certified laboratory must and Quality Control Requirements for (c) Each initial and confirmatory demonstrate and document for each Conducting Validity Tests on Sweat validity test that is qualitative must confirmatory drug test: Patch Samples? (a) The linear range of the analysis; include a control without the compound (b) The limit of detection; (a) Each validity test result must be of interest (i.e., a certified negative (c) The limit of quantitation; based on performing an initial validity control), and a control with the (d) The accuracy and precision at the test on one aliquot and a confirmatory compound of interest at a measurable cutoff concentration; validity test on a second aliquot; and concentration. (e) The accuracy and precision at 40 (b) Each analytical run of sweat patch Section 11.24 What Are the percent of the cutoff concentration; and Requirements for Conducting Each (f) The potential for interfering samples for which an initial or Validity Test on a Sweat Patch Sample? substances. confirmatory validity test is being performed must include the appropriate (a) The initial test for a specific Section 11.17 What Are the Quality calibrators and controls. validity test must use a different Control Requirements When Conducting analytical principle or chemical reaction a Confirmatory Drug Test? Section 11.21 What Are the Analytical and Quality Control Requirements for than that used for the confirmatory test; (a) Each batch of specimens must Conducting Validity Tests on Urine (b) Each initial and confirmatory contain, at a minimum, the following Specimens? validity test that is quantitative must QC samples: include an appropriate calibrator, a (1) A single-point calibrator with its (a) Each validity test result must be control without the compound of drug concentration at the cutoff; based on performing an initial validity interest (i.e., a certified negative (2) At least one control certified to test on one aliquot and a confirmatory control), and a control with the contain no drug or metabolite; validity test on a second aliquot; and compound of interest at a measurable (3) At least one positive control with concentration; and (b) Each analytical run of specimens the drug or metabolite targeted at 25 (c) Each initial and confirmatory for which an initial or confirmatory percent above the cutoff; and validity test that is qualitative must (4) At least one control targeted at or validity test is being performed must include a control without the compound below 40 percent of the cutoff. include the appropriate calibrators and of interest (i.e., a certified negative (b) At least 10 percent of the samples controls. in each batch must be calibrators and control), and a control with the controls. Section 11.22 What Are the compound of interest at a measurable (c) The linear range, limit of Requirements for Conducting Each concentration. detection, and limit of quantitation must Validity Test on a Hair Sample? Section 11.25 What Are the be documented and periodically re- (a) The initial test for a specific Requirements for Conducting Each evaluated for each confirmatory drug Validity Test on a Urine Specimen? test. validity test must use a different (d) A laboratory must document that analytical principle or chemical reaction (a) The requirements for measuring any carryover that may occur between than that used for the confirmatory test; creatinine concentration are as follows: aliquots/extracts in the confirmatory (b) Each initial and confirmatory (1) The creatinine concentration must batch is detectable and corrected. validity test that is quantitative must be measured to one decimal place on both the initial creatinine test and the include an appropriate calibrator, a Section 11.18 What Are the Analytical confirmatory creatinine test; control without the compound of and Quality Control Requirements for (2) The initial creatinine test must interest (i.e., a certified negative Conducting Validity Tests on Hair have a calibrator at 2 mg/dL; control), and a control with the Samples? (3) The initial creatinine test must compound of interest at a measurable (a) Each validity test result must be have a control in the range of 1.0 mg/ concentration; and based on performing an initial validity dL to 1.5 mg/dL, a control in the range test on one aliquot and a confirmatory (c) Each initial and confirmatory of 3 mg/dL to 20 mg/dL, and a control validity test on a second aliquot; and validity test that is qualitative must in the range of 21 mg/dL to 25 mg/dL; (b) Each analytical run of hair samples include a control without the compound and for which an initial or confirmatory of interest (i.e., a certified negative (4) The confirmatory creatinine test validity test is being performed must control), and a control with the (performed on those specimens with a include the appropriate calibrators and compound of interest at a measurable creatinine concentration less than 2 mg/ controls. concentration. dL on the initial test) must have a

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calibrator at 2 mg/dL, a control in the (vii) One control in the range of 11.2 Section 11.26 What Are the range of 1.0 mg/dL to 1.5 mg/dL, and a to 12; Requirements for an HHS-Certified control in the range of 3 mg/dL to 4 mg/ (5) An initial or confirmatory pH Laboratory to Report a Hair Test Result? dL. meter test, if a pH screening test is used, (a) An HHS-certified laboratory must (b) The requirements for measuring must have the following calibrators and report a test result directly to the specific gravity are as follows: controls when the screening result agency’s MRO within an average of 5 (1) The refractometer must report and indicates that the pH is below the lower working days after receipt of the sample display specific gravity to four decimal decision point in use: using the Federal CCF and/or an places. The refractometer must be (i) One calibrator at 4; electronic report. Before any test result interfaced with a laboratory information is reported, it must be certified by a management system (LIMS), computer, (ii) One calibrator at 7; certifying scientist. and/or generate a hard copy of the (iii) One control in the range of 2 to (b) A primary (Sample A) head hair digital electronic display to document 2.8; and sample is reported negative when each the numerical result; (iv) One control in the range 3.2 to 4; (2) The initial and confirmatory and initial drug test is negative or it is negative on a confirmatory drug test and specific gravity tests must have a (6) An initial or confirmatory pH each validity test result indicates that calibrator or control at 1.0000; and meter test, if a pH screening test is used, (3) The initial and confirmatory the sample is a valid head hair sample. must have the following calibrators and (c) A primary (Sample A) head hair specific gravity tests must have the controls when the screening result following controls: sample is reported positive for a specific indicates that the pH is above the upper drug when the initial drug test is (i) One control targeted at 1.0020; decision point in use: (ii) One control in the range of 1.0040 positive and the confirmatory drug test (i) One calibrator at 7; to 1.0180; and is positive. (iii) One control greater than or equal (ii) One calibrator at 10; (d) A primary (Sample A) head hair to 1.0200 but not greater than 1.0250. (iii) One control in the range of 10 to sample is reported adulterated for a (c) Requirements for measuring pH 10.8; and specific adulterant when the initial are as follows: (iv) One control in the range of 11.2 validity test is positive and the (1) Colorimetric pH tests that have the to 12. confirmatory validity test is positive. dynamic range of 2 to 12 to support the (d) Requirements for performing (e) A primary (Sample A) head hair 3 and 11 pH cutoffs and pH meters must oxidizing adulterant tests are as follows: sample is reported as an invalid result if an interfering substance or physical be capable of measuring pH to one (1) The initial test must include an characteristic prevents the laboratory decimal place. Colorimetric pH tests, appropriate calibrator at the cutoff from obtaining a valid negative or dipsticks, and pH paper that have a specified in sections 11.29(d)(3), (4), positive drug test result. narrow dynamic range and do not and (6) for the compound of interest, a (f) An HHS-certified laboratory shall support the cutoffs may be used only to control without the compound of reject a head hair sample for testing determine if an initial pH validity test interest (i.e., a certified negative when a fatal flaw occurs as described in must be performed; control), and at least one control with (2) pH screening tests must have, at a section 16.1 or when a correctable flaw one of the compounds of interest at a minimum, the following controls: as described in section 16.2 is not measurable concentration; and (i) One control below the lower recovered. The laboratory will indicate decision point in use; (2) A confirmatory test for a specific on the Federal CCF that the specimen (ii) One control between the decision oxidizing adulterant must use a was rejected for testing and provide the points in use; and different analytical method than that reason for reporting the rejected for (iii) One control above the upper used for the initial test. Each testing result. decision point in use; confirmatory test batch must include an (g) An HHS-certified laboratory must (3) An initial colorimetric pH test appropriate calibrator, a control without report all non-negative test results for a must have the following calibrators and the compound of interest (i.e., a sample. For example, a head hair controls: certified negative control), and a control sample can be positive for a specific (i) One calibrator at 3; with the compound of interest at a drug and adulterated. (ii) One calibrator at 11; measurable concentration. (h) An HHS-certified laboratory must (iii) One control in the range of 2 to (e) The requirements for measuring report the concentration of the drug or 2.8; the nitrite concentration are that the metabolite for a positive result. (iv) One control in the range 3.2 to 4; initial and confirmatory nitrite tests (i) An HHS-certified laboratory must (v) One control in the range of 4.5 to must have a calibrator at the cutoff report numerical values that support a 9; concentration, a control without nitrite sample that is reported adulterated or (vi) One control in the range of 10 to (i.e., certified negative urine), one invalid (as appropriate). 10.8; and control in the range of 200 mcg/mL to (vii) One control in the range of 11.2 (j) When the concentration of an 400 mcg/mL, and one control in the analyte exceeds the linear range of the to 12; range of 500 mcg/mL to 625 mcg/mL. (4) An initial pH meter test, if a pH standard curve, an HHS-certified screening test is not used, must have the (f) The requirements for performing laboratory may report to the MRO that following calibrators and controls: other adulterant tests are that the initial the quantitative value exceeds the linear (i) One calibrator at 4; and confirmatory tests for any ‘‘other’’ range of the test, that the quantitative (ii) One calibrator at 7; adulterant that may be identified in the value is greater than or equal to (insert (iii) One calibrator at 10; future must include an appropriate the value for the upper limit of the (iv) One control in the range of 2 to calibrator, a control without the linear range), or may report an accurate 2.8; compound of interest (i.e., a certified quantitative value above the upper limit (v) One control in the range 3.2 to 4; negative control), and a control with the of the linear range that was obtained by (vi) One control in the range of 10 to compound of interest at a measurable diluting an aliquot of the dissolved head 10.8; and concentration. hair sample.

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(k) An HHS-certified laboratory may (g) An HHS-certified laboratory shall (b) A primary (Patch A) sweat patch transmit a result to the MRO by various reject an oral fluid specimen for testing sample is reported negative when each electronic means (for example, when a fatal flaw occurs as described in initial drug test is negative or it is teleprinters, facsimile, or computer) in a section 16.1 or when a correctable flaw negative on a confirmatory drug test and manner designed to ensure as described in section 16.2 is not each validity test result indicates that confidentiality of the information. A recovered. The laboratory will indicate the sample is a valid sweat patch result may not be reported verbally by on the Federal CCF that the specimen sample. telephone. A laboratory must ensure the was rejected for testing and provide the (c) A primary (Patch A) sweat patch security of the data transmission and reason for reporting the rejected for sample is reported positive for a specific limit access to any data transmission, testing result. drug when the initial drug test is storage, and retrieval system. (h) An HHS-certified laboratory must positive and the confirmatory drug test (l) For all test results, an HHS- report all non-negative test results for a is positive. certified laboratory may fax, courier, specimen. For example, an oral fluid (d) A primary (Patch A) sweat patch mail, or electronically transmit a legible specimen can be positive for a specific sample is reported adulterated for a image or copy of the completed Federal drug and adulterated. specific adulterant when the initial CCF, and/or forward a computer- (i) An HHS-certified laboratory must validity test is positive and the generated electronic report. However, report the concentration of the drug or confirmatory validity test is positive. for non-negative results, the laboratory metabolite for a positive result. (e) A primary (Patch A) sweat patch sample is reported as an invalid result must fax, courier, mail, or electronically (j) An HHS-certified laboratory must if an interfering substance or physical transmit a legible image or copy of the report numerical values that support a characteristic prevents the laboratory completed Federal CCF. specimen that is reported adulterated, from obtaining a valid negative or substituted, or invalid (as appropriate). Section 11.27 What Are the positive drug test result. Requirements for an HHS-Certified (k) When the concentration of an (f) An HHS-certified laboratory shall Laboratory to Report an Oral Fluid Test analyte exceeds the linear range of the reject a primary (Patch A) sweat patch Result? standard curve, an HHS-certified sample for testing when a fatal flaw (a) An HHS-certified laboratory must laboratory may report to the MRO that occurs as described in section 16.1 or report a test result directly to the the quantitative value exceeds the linear when a correctable flaw as described in agency’s MRO within an average of 5 range of the test, that the quantitative section 16.2 is not recovered. The working days after receipt of the value is greater than or equal to (insert laboratory will indicate on the Federal specimen using the Federal CCF and/or the value for the upper limit of the CCF that the sample was rejected for an electronic report. Before any test linear range), or may report an accurate testing and provide the reason for result is reported, it must be certified by quantitative value above the upper limit reporting the rejected for testing result. a certifying scientist. of the linear range that was obtained by (g) An HHS-certified laboratory must (b) A primary (Tube A) oral fluid diluting an aliquot of the specimen. report all non-negative test results for a specimen is reported negative when (l) An HHS-certified laboratory may sample. For example, a sweat patch each initial drug test is negative or it is transmit a result to the MRO by various sample can be positive for a specific negative on a confirmatory drug test and electronic means (for example, drug and adulterated. each validity test result indicates that teleprinters, facsimile, or computer) in a (h) An HHS-certified laboratory must the specimen is a valid oral fluid manner designed to ensure report the concentration of the drug or specimen. confidentiality of the information. A metabolite for a positive result. (c) A primary (Tube A) oral fluid result may not be reported verbally by (i) An HHS-certified laboratory must specimen is reported positive for a telephone. A laboratory must ensure the report numerical values that support a specific drug when the initial drug test security of the data transmission and specimen that is reported adulterated or is positive and the confirmatory drug limit access to any data transmission, invalid (as appropriate). test is positive. For only those oral fluid storage, and retrieval system. (j) When the concentration of an tests that result in a confirmed positive (m) For all test results, an HHS- analyte exceeds the linear range of the for marijuana, the laboratory must not certified laboratory may fax, courier, standard curve, an HHS-certified report the result for the oral fluid mail, or electronically transmit a legible laboratory may report to the MRO that specimen to the MRO but, instead must image or copy of the completed Federal the quantitative value exceeds the linear test the primary (Bottle A) urine CCF, and/or forward a computer- range of the test, that the quantitative specimen for marijuana and report that generated electronic report. However, value is greater than or equal to (insert result in accordance with section 11.29. for non-negative results, the laboratory the value for the upper limit of the (d) A primary (Tube A) oral fluid must fax, courier, mail, or electronically linear range), or may report an accurate specimen is reported adulterated for a transmit a legible image or copy of the quantitative value above the upper limit specific adulterant when the initial completed Federal CCF. of the linear range that was obtained by diluting an aliquot of the eluted sweat validity test is positive and the Section 11.28 What Are the patch sample. confirmatory validity test is positive. Requirements for an HHS-Certified (e) A primary (Tube A) oral fluid (k) An HHS-certified laboratory may Laboratory To Report a Sweat Patch specimen is reported as an invalid result transmit a result to the MRO by various Test Result? if an interfering substance or physical electronic means (for example, characteristic prevents the laboratory (a) An HHS-certified laboratory must teleprinters, facsimile, or computer) in a from obtaining a valid negative or report a test result directly to the manner designed to ensure positive drug test result. agency’s MRO within an average of 5 confidentiality of the information. A (f) A primary (Tube A) oral fluid working days after receipt of the sample result may not be reported verbally by specimen is reported substituted if the using the Federal CCF and/or an telephone. A laboratory must ensure the sample does not exhibit the electronic report. Before any test result security of the data transmission and characteristics of a normal oral fluid is reported, it must be certified by a limit access to any data transmission, specimen. certifying scientist. storage, and retrieval system.

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(l) For all test results, an HHS- (4) The presence of halogen (e.g., initial and confirmatory specific gravity certified laboratory may fax, courier, bleach, iodine, fluoride) is verified tests (i.e., a refractometer is used to test mail, or electronically transmit a legible using either a general oxidant both aliquots) on two separate aliquots. image or copy of the completed Federal colorimetric test (with a greater than or (f) A primary (Bottle A) urine CCF, and/or forward a computer- equal to 200 mcg/mL nitrite-equivalent specimen is reported dilute when the generated electronic report. However, cutoff or a greater than or equal to 50 creatinine concentration is greater than for non-negative results, the laboratory mcg/mL chromium (VI)-equivalent or equal to 2 mg/dL but less than 20 mg/ must fax, courier, mail, or electronically cutoff) or halogen colorimetric test dL and the specific gravity is greater transmit a legible image or copy of the (halogen concentration greater than or than 1.0010 but less than 1.0030 on a completed Federal CCF. equal to the LOD) for the initial test on single aliquot. the first aliquot and a different (g) A primary (Bottle A) urine Section 11.29 What Are the confirmatory test (e.g., multi-wavelength specimen is reported as an invalid result Requirements for an HHS-Certified spectrophotometry, ion when: Laboratory To Report a Urine Test chromatography, inductively coupled (1) Inconsistent creatinine Result? plasma-mass spectrometry) with a concentration and specific gravity (a) An HHS-certified laboratory must specific halogen concentration greater results are obtained (i.e., the creatinine report a test result directly to the than or equal to the LOD of the concentration is less than 2 mg/dL on agency’s MRO within an average of 5 confirmatory test on the second aliquot; both the initial and confirmatory working days after receipt of the (5) The presence of glutaraldehyde is creatinine tests and the specific gravity specimen using the Federal CCF and/or verified using either an aldehyde test is greater than 1.0010 but less than an electronic report. Before any test (aldehyde present) or the characteristic 1.0200 on the initial and/or result is reported, it must be certified by immunoassay response on one or more confirmatory specific gravity test, the a certifying scientist. drug immunoassay tests for the initial specific gravity is less than or equal to (b) A primary (Bottle A) urine test on the first aliquot and GC/MS for 1.0010 on both the initial and specimen is reported negative when the confirmatory test with the confirmatory specific gravity tests and each initial drug test is negative or it is glutaraldehyde concentration greater the creatinine concentration is greater negative on a confirmatory drug test and than or equal to the LOD of the analysis than or equal to 2 mg/dL on either or each validity test result indicates that on the second aliquot; both the initial or confirmatory the specimen is a valid urine specimen. (6) The presence of pyridine creatinine tests); (c) A primary (Bottle A) urine (pyridinium chlorochromate) is verified (2) The pH is greater than or equal to specimen is reported positive for a using either a general oxidant 3 and less than 4.5 or greater than or specific drug when the initial drug test colorimetric test (with a greater than or equal to 9 and less than 11 using either is positive and the confirmatory drug equal to 200 mcg/mL nitrite-equivalent a colorimetric pH test or pH meter for test is positive. cutoff or a greater than or equal to 50 the initial test and a pH meter for the (d) A primary (Bottle A) urine mcg/mL chromium (VI)-equivalent confirmatory test on two separate specimen is reported adulterated when: cutoff) or a chromium (VI) colorimetric aliquots; (1) The pH is less than 3 or greater test (chromium (VI) concentration (3) The nitrite concentration is greater than or equal to 11 using either a pH greater than or equal to 50 mcg/mL) for than or equal to 200 mcg/mL using a meter or a colorimetric pH test for the the initial test on the first aliquot and nitrite colorimetric test or greater than initial test on the first aliquot and a pH GC/MS for the confirmatory test with or equal to the equivalent of 200 mcg/ meter for the confirmatory test on the the pyridine concentration greater than mL nitrite using a general oxidant second aliquot; or equal to the LOD of the analysis on colorimetric test for both the initial test (2) The nitrite concentration is greater the second aliquot; and the confirmatory test or using either than or equal to 500 mcg/mL using (7) The presence of a surfactant is initial test and the nitrite concentration either a nitrite colorimetric test or a verified by using a surfactant is greater than or equal to 200 mcg/mL general oxidant colorimetric test for the colorimetric test with a greater than or but less than 500 mcg/mL for a different initial test on the first aliquot and a equal to 100 mcg/mL dodecylbenzene confirmatory test (e.g., multi-wavelength different confirmatory test (e.g., multi- sulfonate-equivalent cutoff for the initial spectrophotometry, ion wavelength spectrophotometry, ion test on the first aliquot and a different chromatography, capillary chromatography, capillary confirmatory test (e.g., multi-wavelength electrophoresis) on two separate electrophoresis) on the second aliquot; spectrophotometry) with a greater than aliquots; (3) The presence of chromium (VI) is or equal to 100 mcg/mL dodecylbenzene (4) The possible presence of verified using either a general oxidant sulfonate-equivalent cutoff on the chromium (VI) is determined using the colorimetric test (with a greater than or second aliquot; or same chromium (VI) colorimetric test equal to 50 mcg/mL chromium (VI)- (8) The presence of any other with a cutoff greater than or equal to 50 equivalent cutoff) or a chromium (VI) adulterant not specified in 4(iii) through mcg/mL chromium (VI) for both the colorimetric test (chromium (VI) 4(vii) of this section is verified using an initial test and the confirmatory test on concentration greater than or equal to 50 initial test on the first aliquot and a two separate aliquots; mcg/mL) for the initial test on the first different confirmatory test on the (5) The possible presence of a halogen aliquot and a different confirmatory test second aliquot. (e.g., bleach, iodine, fluoride) is (e.g., multi-wavelength (e) A primary (Bottle A) urine determined using the same halogen spectrophotometry, ion specimen is reported substituted when colorimetric test with a cutoff greater chromatography, atomic absorption the creatinine concentration is less than than or equal to the LOD for both the spectrophotometry, capillary 2 mg/dL and the specific gravity is less initial test and the confirmatory test on electrophoresis, inductively coupled than or equal to 1.0010 or greater than two separate aliquots or relying on the plasma-mass spectrometry) with the or equal to 1.0200 on both the initial odor of the specimen as the initial test; chromium (VI) concentration greater and confirmatory creatinine tests (i.e., (6) The possible presence of than or equal to the LOD of the the same colorimetric test may be used glutaraldehyde is determined by using confirmatory test on the second aliquot; to test both aliquots) and on both the the same aldehyde test (aldehyde

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present) or characteristic immunoassay laboratory may report to the MRO that Section 11.32 What Statistical response on one or more drug the quantitative value exceeds the linear Summary Report Must an HHS-Certified immunoassay tests for both the initial range of the test, that the quantitative Laboratory Provide? test and the confirmatory test on two value is greater than or equal to (insert (a) An HHS-certified laboratory must separate aliquots; the value for the upper limit of the provide to each Federal agency for (7) The possible presence of an linear range), or may report an accurate which testing is conducted a oxidizing adulterant is determined by quantitative value above the upper limit semiannual statistical summary report using the same general oxidant of the linear range that was obtained by for each type of specimen tested that colorimetric test (with a greater than or diluting an aliquot of the specimen. contains the following information: equal to 200 mcg/mL nitrite-equivalent cutoff, a greater than or equal to 50 mcg/ (m) An HHS-certified laboratory may Reporting Period: (inclusive dates) mL chromium (VI)-equivalent cutoff, or transmit a result to the MRO by various Laboratory Name and Address Federal Agency Name a halogen concentration is greater than electronic means (for example, (1) Specimen Results Reported (total or equal to the LOD) for both the initial teleprinters, facsimile, or computer) in a manner designed to ensure number) test and the confirmatory test on two By Type of Test: separate aliquots; confidentiality of the information. A result may not be reported verbally by (i) Pre-employment (number) (8) The possible presence of a (ii) Post-Accident (number) surfactant is determined by using the telephone. A laboratory must ensure the security of the data transmission and (iii) Random (number) same surfactant colorimetric test with a (iv) Reasonable Suspicion/Cause limit access to any data transmission, greater than or equal to 100 mcg/mL (number) storage, and retrieval system. dodecylbenzene sulfonate-equivalent (v) Return-to-Duty (number) cutoff for both the initial test and the (n) For all test results, an HHS- (vi) Follow-up (number) confirmatory test on two separate certified laboratory may fax, courier, (vii) Type of Test Not Noted on CCF aliquots or a foam/shake test for the mail, or electronically transmit a legible (number) initial test; image or copy of the completed Federal (2) Specimens Reported (9) Interference occurs on the CCF, and/or forward a computer- (i) Negative (number) immunoassay drug tests on two separate generated electronic report. However, (ii) Negative and Dilute (number) aliquots (i.e., valid immunoassay drug for non-negative results, the laboratory (3) Specimens Reported as Rejected test results cannot be obtained); must fax, courier, mail, or electronically for Testing (total number) (10) Interference with the GC/MS drug transmit a legible image or copy of the By Reason: confirmation assay occurs on at least completed Federal CCF. (i) Fatal flaw (number) two separate aliquots of the specimen (ii) Uncorrected Flaw (number) and the laboratory is unable to identify Section 11.30 How Long Must an HHS- (4) Specimens Reported as Positive the interfering substance; Certified Laboratory Retain a Specimen? (total number) (11) The physical appearance of the By Drug: specimen is such that testing the system (a) An HHS-certified laboratory must (i) Marijuana Metabolite (number) may damage the laboratory’s retain a specimen that was reported (ii) Cocaine Metabolite (number) instruments; or either drug positive, adulterated, (iii) Opiates: (12) If the physical appearances of substituted, or as an invalid result for a (A) Codeine (number) Bottles A and B are clearly different, the minimum of 1 year. (B) Morphine (number) test result for Bottle A is one of the (b) A retained specimen must be kept (C) 6-AM (number) (iv) Phencyclidine (number) reasons stated in (i) through (xi) of this in a secured location that is appropriate section and/or was screened negative for (v) Amphetamines: for that type of specimen (e.g., frozen (A) Amphetamine (number) drugs. storage (¥20°C or less) for urine) to (h) An HHS-certified laboratory shall (B) Methamphetamine (number) ensure its availability for any necessary reject a primary (Bottle A) urine (C) MDMA retesting during an administrative or specimen for testing when a fatal flaw (D) MDA judicial proceeding. occurs as described in section 16.1 or (E) MDEA when a correctable flaw as described in (c) Within the 1-year storage period, a (5) Adulterated (number) section 16.2 is not recovered. The Federal agency may request a laboratory (6) Substituted (number) laboratory will indicate on the Federal to retain a specimen for an additional (7) Invalid Result (number) CCF that the specimen was rejected for period of time. If no such request is (b) The report must be submitted by testing and provide the reason for received, a specimen may be discarded, mail, fax, or email within 14 working reporting the rejected for testing result. except that the laboratory must be days after the end of the semiannual (i) An HHS-certified laboratory must required to maintain any specimens period. The summary report must not report all non-negative test results for a under legal challenge for an indefinite include any personal identifying specimen. For example, a specimen can period. information. be positive for a specific drug and (c) The HHS-certified laboratory must adulterated. Section 11.31 How Long Must an HHS- make available copies of an agency’s test (j) An HHS-certified laboratory must Certified Laboratory Retain Records? results when requested by the Secretary report the concentration of the drug or or by the Federal agency for which the (a) An HHS-certified laboratory must metabolite for a positive result. laboratory is performing drug-testing (k) An HHS-certified laboratory must retain all records generated to support services. report numerical values that support a test results for at least 2 years. (d) The HHS-certified laboratory must specimen that is reported adulterated, (b) A Federal agency may instruct, in make available qualified personnel to substituted, or invalid (as appropriate). writing, the laboratory to maintain testify in a proceeding against a Federal (l) When the concentration of an records associated with a particular employee when that proceeding is based analyte exceeds the linear range of the specimen under legal challenge for an on a test result reported by the HHS- standard curve, an HHS-certified indefinite period. certified laboratory.

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Section 11.33 What Information Is Section 11.35 What Information Must POCT device, or as a set of compatible Available to the Donor? an HHS-Certified Laboratory Provide To devices or procedures as established in Its Private Sector Clients? section 12.6. (a) A Federal employee who is the When an HHS-certified laboratory (b) The Secretary will publish a list of subject of a drug test may, upon written the POCT devices that are SAMHSA- request through the MRO and the uses procedures to test private sector client specimens that are different from certified for use in the Federal Federal agency, have access to any Workplace Drug Testing Program in the those for which it is certified, it must records relating to his or her drug test, Federal Register. any records relating to the results of any inform the private sector client that its relevant certification, review, or specimens are not being tested under Section 12.3 What Is the Rationale for revocation of certification proceedings, the Guidelines. the Additional Requirements To Use POCT Devices Besides FDA Clearance? and access to a documentation package. Subpart L—Point of Collection Test (b) A standard documentation (POCT) The FDA clears POCT drug test package provided by an HHS-certified devices by making a finding of Section 12.1 What Is the Goal of This substantial equivalence to a legally laboratory must consist of the following Subpart? items: marketed device. FDA’s determination (a) Employees of Federal agencies are of substantial equivalence does not (1) A cover sheet that provides a brief in some cases located in remote areas of ensure that the test will satisfy description of the drug testing the country if they are serving with the minimum performance requirements procedures and any specimen validity Department of Interior, or overseas if that are necessary for use in the Federal tests performed on the donor’s they are serving with the Department of Workplace Drug Testing Program. specimen; State. They are often in locations with Therefore, due to the critically (2) A table of contents page that lists few employees as is often the case when important nature of testing under these by page number all documents and they are serving on American Indian Guidelines, there is need for additional materials in the package; reservations or in embassies in small assurance in the Federal Workplace (3) A copy of the Federal CCF with foreign countries. It is often unrealistic Drug Testing Program that the FDA- any attachments, internal chain of to expect that a drug testing program in cleared kits are effectively finding drugs custody records for the specimen, such places would operate in the same at the specified cutoff concentrations memoranda (if any) generated by the fashion as one that serves employees in and effectively determining the absence laboratory, and a copy of the electronic the Washington, DC, area. It is in these of drugs. report (if any) generated by the circumstances and in cases where it is Section 12.4 What Types of POCT laboratory; critical to receive an immediate test Devices Are There? result that POCT tests play an important (4) A brief description of the role. POCT devices are: laboratory’s initial drug and validity test (b) Yet a POCT offers a particular (a) Non-instrumented for which the procedures, instrumentation, batch challenge to the Federal Workplace endpoint result is obtained by visual quality control requirements, and copies Drug Testing Program because the evaluation (i.e., read by human eye); or (b) Instrumented for which the result of the initial test data for the donor’s device that is used to produce a negative is obtained by instrumental evaluation specimen with all calibrators and test result is really equivalent to a (e.g., densitometer, spectrophotometer, controls identified and copies of all laboratory test to which the normal fluorometer). internal chain of custody documents laboratory procedures and requirements related to the initial tests; cannot readily apply. Thus, while the Section 12.5 What Must a POCT (5) A brief description of the sections of the Guidelines related to Device Manufacturer Submit to the laboratory’s confirmatory drug and specimens, collection procedures, Secretary To Have Its POCT Device validity test procedures, collections sites, chain of custody, drug Initially Included on the List of instrumentation, batch quality control and validity testing and others do apply, SAMHSA-Certified POCTs? requirements, and copies of the it is necessary to establish requirements A POCT device manufacturer must confirmatory test data for the donor’s particular to POCTs. submit the following to the Secretary: specimen with all calibrators and (c) This subpart establishes the (a) A copy of the FDA letter stating controls identified and copies of all criteria for POCT devices that may be that the FDA has cleared the specific internal chain of custody documents used as part of the Federal Workplace POCT device; related to the confirmatory tests; and Drug Testing Program, when Federal (b) A copy of the labeling submitted (6) A copy of the resume or agencies may use a POCT, what the to FDA for the cleared device; curriculum vitae for the certifying responsibilities are of a Federal agency (c) A self-certification that the device scientist that certified the test result. which chooses to use a POCT, and the meets the requirements contained in the procedures that must be followed in FDA’s good manufacturing practices Section 11.34 What Type of using a POCT. regulations; Relationship Is Prohibited Between an (d) A description of the storage HHS-Certified Laboratory and an MRO? Section 12.2 What POCT Devices May requirements for the device; Be Used in a Federal Workplace Drug (e) A total of 100 POCT devices and (a) An MRO must not be an employee, Testing Program? related testing procedures in agent of, or have any financial interest (a) A POCT device that may be used representative numbers from all in an HHS-certified laboratory for which in a Federal Workplace Drug Testing currently available manufactured lots of the MRO is reviewing drug test results. Program is one which: the device for HHS testing to evaluate (b) An MRO must not derive any (1) Is FDA-cleared; and the performance of the POCT device(s) financial benefit by having a Federal (2) Effectively determines the for drug and validity testing; and agency use a specific HHS-certified presence or absence of drugs and (f) An accounting of the expiration laboratory that may be construed as a determines the validity of a specimen, date and number of devices for each potential conflict of interest. either as an integral function of the existing manufactured lot of the device.

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Section 12.6 What Criteria Will the (e) Inspect the POCT sites periodically (g) For urine only PT samples, the Secretary Use To Place a POCT Device to ensure compliance with these specific gravity must be between 1.0000 on the List of SAMHSA-Certified Guidelines; and 1.0010 or between 1.0200 and POCTs? (f) Ensure that on a quarterly basis 1.0300. (a) The Secretary shall evaluate the sets of HHS-contractor prepared PT (h) For urine only PT samples, the pH POCT devices submitted by the samples (that satisfy the requirements in must be between 1 and 3 or between 10 manufacturer using the following section 12.9) are submitted to challenge to 12. criteria: the performance of each POCT drug and (i) For oral fluid only PT samples, the (1) Correctly identify at least 80 validity test device at each site; IgG must be between 0.1 and 1.0. percent of the total drug challenges; (g) Maintain records on those who Section 12.10 What Are the Inspection (2) For an individual drug, correctly have been SAMHSA-certified as POCT Requirements for a Federal Agency identify at least 80 percent of the total testers including records of their Wishing To Use a POCT? drug challenges; training; (3) Correctly identify at least 80 (h) Retain records on the results of the (a) Each Federal agency is to inspect percent of the total validity test PT samples and the results of all POCTs each POCT site periodically to ensure challenges; by test and by specimen; compliance with these Guidelines; and (4) For each specific validity test, (i) Provide semiannual reports to the (b) The Federal agency must maintain correctly report at least 80 percent of the Secretary with regard to the use of the a record of the inspections for a challenges for the specific validity test; POCT device(s) in keeping with section minimum of 2 years. and 12.25; Section 12.11 What Is the (5) Must not report any sample as (j) Investigate each failure as provided Responsibility of the Secretary To adulterated with a compound that is not in section 12.12 and determine whether Inspect a Federal Agency Using POCT? present in the sample. it was related to failure to follow (a) The Secretary shall conduct a (b) The Secretary will use PT samples procedure in which case to take action semiannual inspection of each Federal as described in section 12.9 to evaluate against the POCT tester or whether it agency that uses POCT. the POCT device. was related to the POCT device itself; (b) The inspection will review the and Section 12.7 What Is Required for a Federal agency’s records to include: FDA Cleared POCT Device To Continue (k) If any failure under (j) of this (1) The Federal agency’s standard on the List of SAMHSA-Certified section is related to the device itself, operating procedure manual; Devices? immediately inform the Secretary who (2) POCT tester training records; shall temporarily suspend the use of the (3) POCT device quarterly PT results; To maintain a POCT device on the POCT device. SAMHSA-certified list, the and manufacturer: Section 12.9 What Are the Qualitative (4) POCT quality assurance data (a) Must agree to submit any design and Quantitative Specifications for PT maintained by each POCT tester and changes or alterations made to the Samples That Are Used To Evaluate site. device after it has been SAMHSA- Test Devices Submitted by Section 12.12 What Is a Failure for the certified, so that the Secretary may Manufacturers or for a Federal Agency Purposes of the POCT? determine whether additional testing is To Evaluate a POCT Site and Tester? A failure means the following: required; and A PT sample that is used to evaluate (b) Must submit 50 POCT devices and (a) For a drug POCT, the device failed test devices submitted by manufacturers related testing procedures annually to to properly identify a negative or or to challenge a POCT drug or validity the Secretary in representative numbers positive PT sample; test device is a sample: from all currently available (b) For a validity POCT, the device (a) That contains one or more drugs or manufactured lots of the device for HHS failed to identify a PT sample that was metabolites in the drug classes for testing to evaluate the performance of adulterated, substituted or diluted; or which each POCT device must have the the POCT device(s) for drug and validity (c) The device reported a false capability to test. testing using criteria established in negative after confirmation by a (b) The concentration of the drugs section 12.6. laboratory in keeping with section and/or metabolites are at least 20 12.21(b). Section 12.8 What Are the percent above the cutoff concentration Responsibilities of a Federal Agency or between 50 and 75 percent of the Section 12.13 What Is the That Wishes To Conduct POCT? cutoff concentration for the initial test. Responsibility of the Secretary When a Failure Is Reported? A Federal agency which seeks to (c) That contains no measurable conduct POCT as part of its Federal amount of a target drug and/or (a) If, after reviewing the information Workplace Drug Testing Program must: metabolite (i.e., a negative sample). from the Federal agency and all other (a) Use only POCT devices that are on (d) That may contain an interfering agencies using the same device as well the SAMHSA-certified list published by substance, an adulterant, or a specimen as the circumstances of the failure, the the Secretary in accordance with section that meets the criteria for a substituted Secretary determines that there is a 12.2(b); specimen that would challenge the problem with the device, the Secretary (b) Develop a standard operating POCT validity tests. may: procedure manual for POCT testers to (e) For urine only PT samples, the (1) Temporarily suspend the use of use; nitrite concentration must be between the device in the Federal Workplace (c) Ensure that POCT testers meet the 650 mcg/mL and 800 mcg/mL or Drug Testing Program if immediate requirements of section 12.16; between 250 mcg/mL and 400 mcg/mL. action is necessary in order to protect (d) Ensure that all other pertinent (f) For urine only PT samples, the the interests of the United States and its requirements of these Guidelines are creatinine concentration must be employees; or adhered to including the requirements between 5 mg/dL and 20 mg/dL or (2) Remove the device from the with regard to POCT sites; between 1 mg/dL and 5 mg/dL. SAMHSA-certified list.

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(b) If the Secretary suspends the use Section 12.16 What Are the POCT tester must send the urine split of the device, the Secretary shall: Requirements To Be a POCT Tester? specimen bottles to an HHS-certified (1) Inform all Federal agencies which (a) An individual is considered to be laboratory for testing rather than the oral are using the device of the action by a POCT tester for a specific POCT fluid specimen tubes. For all other placing notice in the Federal Register of device when the Federal agency presumptive positive drug test results such action; and documents that the individual has: on an oral fluid POCT, the POCT tester (2) Notify the manufacturer that the (1) Received supervised and validated may only send the oral fluid split device may be removed from the list of training in how to use and interpret the specimen tubes to the HHS-certified SAMHSA-certified devices. In this results of the POCT device; laboratory for testing. event, the manufacturer has 30 days (2) Received training on chain of (f) The POCT tester must complete the from the date of notification to reply. custody, reporting, and recordkeeping POCTs on an aliquot before beginning (3) Based on the Secretary’s procedures; the testing of another specimen using investigation and any information (3) Read and understands these POCTs. provided by the manufacturer, the Guidelines; and Section 12.19 What Are the Quality Secretary shall decide whether the (4) Demonstrated proficiency that has Control Requirements When Conducting device should remain on the list of been documented by the Federal agency POCTs? SAMHSA-certified devices. by completing five consecutive error- (a) For drug POCTs: (i) If the Secretary determines that the free POCTs. (1) Each day testing is performed device is to be removed from the list of (b) An individual may be trained to using devices with visually read SAMHSA-certified devices, the list will use all or some of the devices on the list endpoints (i.e., a color appearing or be revised accordingly. of SAMHSA-certified devices. disappearing that indicates a positive (ii) If the Secretary decides that it is Section 12.17 What Happens if a result using that device), each not to be removed from the list of POCT Site or Tester Does Not Satisfy the individual performing drug tests using SAMHSA-certified devices, the Minimum Technical Requirements? these devices must test at least one suspension will be lifted by publication negative control (i.e., a sample certified of a notice in the Federal Register. The POCT site or tester may not perform POCTs for a Federal agency to contain no drug or drug metabolite) (c) If the Secretary has cause to until acceptable performance has been and one positive control (i.e., a sample remove the device from the list of documented. with the concentration of the drugs or SAMHSA-certified devices in the metabolites in the range of 25 percent absence of a need for immediate action, Section 12.18 What Are the above the cutoff concentration) before the Secretary shall notify the Requirements for Conducting a POCT? donor specimens are tested. These manufacturer that the device may be (a) A donor must not have access to quality control samples must be tested removed from the list of SAMHSA- the POCT device. and the results interpreted with the certified devices. In this event, the (b) After the donor leaves the positive control testing positive and the manufacturer has 30 days from the date collection site and after the split negative control testing negative before of notification to reply. Based on the specimens are labeled and sealed by the donor specimens are tested and reported Secretary’s investigation and any collector, a POCT tester (which may be each day. information provided by the the collector) is permitted to break the (2) Each day testing is performed manufacturer, the Secretary will decide label/seal on the primary specimen and using devices with semi-automated or whether the device should remain on remove an aliquot to conduct the POCT. automated testing devices with machine the approved list. (c) The POCT tester must maintain read endpoints (i.e., spectrophotometer), (d) If the Secretary determines that and document chain of custody for the at least one negative control (i.e., a there is a problem with the device, the primary specimen and the aliquot used sample certified to contain no drug or Secretary shall notify the FDA so that for the POCT on an OMB-approved drug metabolite) and one positive the FDA can evaluate whether any custody and control form. control (i.e., a sample with the action under the Food, Drug, and (d) If the aliquot tests negative on the concentration of the drugs or Cosmetic Act is necessary. drug POCTs, the aliquot, primary, and metabolites in the range of 25 percent Section 12.14 How Can a split specimens must be discarded above the cutoff concentration) must be Manufacturer Apply To Have a Device unless the split specimens are to be tested on each device used. These Reinstated on the List of SAMHSA- submitted as part of the quality quality control samples must be tested Certified Devices? assurance program. and the results interpreted with the (e) If the aliquot tests presumptive positive control testing positive and the (a) The manufacturer may reapply for drug positive, adulterated, substituted, negative control testing negative before SAMHSA-certification in accordance or invalid on the POCTs, the primary donor specimens are tested and reported with section 12.5. specimen must be resealed using a new each day. (b) Upon reapplication, the tamper-evident label/seal and sent with (b) For validity POCTs, each day manufacturer must submit a statement the split specimen to an HHS-certified testing is performed, at least one control describing what has been done to laboratory for testing. The POCT tester that is normal for the specific validity overcome the problems that resulted in must initial and date the new label/seal test and one control that is abnormal the device being removed from the list that was used to reseal the primary must be tested. The results must be of SAMHSA-certified devices. specimen. The POCT tester must report correct before donor specimens are Section 12.15 Which Types of the POCT result on the OMB-approved tested. Specimens May Be Tested Using a custody and control form. The aliquot (c) At least one specimen out of every POCT? used to conduct the POCTs is discarded. 10 specimens that test negative must be When a POCT is conducted on an oral submitted to an HHS-certified (a) Oral fluid (saliva) fluid specimen aliquot and it is laboratory as part of a quality assurance (b) Urine presumptive positive for marijuana, the program.

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Section 12.20 What Action Must Be (1) A brief description of the POCT use a specific POCT device that may be Taken When a POCT Quality Control procedures, quality control construed as a potential conflict of Sample Fails? requirements, copies of the POCT test interest. data for the donor’s specimen with all For (a) or (b) in section 12.19, the Section 12.27 What Type of calibrators and controls identified as failed quality control sample must be Relationship Can Exist Between a related to the POCTs; sent to an HHS-certified laboratory. The Manufacturer of a POCT Device or a (2) A copy of the Federal CCF with POCT tester must successfully test QC POCT Site Operation and an HHS- any attachments, internal chain of samples until acceptable results are Certified Laboratory? custody records for the specimen, obtained before testing donor memoranda (if any) generated by the A manufacturer of a POCT device or specimens. If acceptable QC results POCT tester, and a copy of the report a POCT site operation can freely enter cannot be obtained, donor specimens generated by the POCT tester; into any relationship with an HHS- must be sent directly to an HHS- (3) A copy of the resume or Certified laboratory. certified laboratory. curriculum vitae for the POCT tester; Subpart M—Instrumented Initial Test Section 12.21 What Does a POCT and Facility (IITF) Tester Do With a Specimen After (4) A copy of the Federal agency Conducting a POCT? documentation of training of the POCT Section 13.1 What Is an HHS-Certified tester for the specific POCT device. IITF? (a) Each presumptive positive, adulterated, or substituted specimen Section 12.25 What Statistical An HHS-certified IITF: together with its split is sent to an HHS- Summary Report Must a Federal Agency (a) Is a facility at a permanent location certified laboratory for additional Provide to the Secretary? that conducts only instrumented initial testing. drug and validity tests (as described for (a) A Federal agency must provide the an HHS-certified laboratory in subpart (b) A POCT tester must send one of Secretary a semiannual statistical every 10 negative specimens together K); summary report that contains the (b) Has satisfied the certification with its split to an HHS-certified following information: laboratory to be tested for quality requirements for each type of specimen (1) The number of specimens tested the IITF wants to test; control purposes. Other negative (2) The number grouped by reason for specimens must be discarded. (c) Has passed 3 consecutive sets of test as follows: PT samples for each type of specimen to Section 12.22 How is a POCT Negative (i) Random be tested and an initial inspection Result Reported? (ii) All others reasons combined before becoming HHS-certified; (a) A negative result is reported (3) The number that were: (d) Participates in a quarterly directly to an MRO within 3 (on (i) Screened positive for each drug maintenance PT sample program and is average) working days after the POCT is (listed separately) inspected every 6 months; and conducted. (ii) Screened as adulterated (e) Is managed by a full-time (b) A POCT tester may report a (iii) Screened as substituted responsible technician (RT). (iv) Invalid Result negative test result to an MRO using an Section 13.2 Which Types of electronic report format. The electronic (4) The total number of quality control Specimens May Be Tested at an HHS- report must be transmitted to the MRO samples tested Certified IITF? in a manner that ensures the (i) The number of acceptable QC sample (a) Hair results confidentiality and security of the (b) Oral fluid (saliva) information. (ii) The number of failed QC sample (c) Sweat (patch) (c) A POCT tester may not report test results (d) Urine results telephonically. However, the (b) The report must be submitted by MRO may contact the POCT tester by mail, fax, or email within 14 working Section 13.3 What Cutoff telephone if he or she has any concern days after the end of the semiannual Concentrations Are Used by an HHS- regarding the negative result. period. Certified IITF for the Drug Tests? (c) The Federal agency must make Section 12.23 How Long Must Records An HHS-certified IITF must use the available copies of an agency’s POCT Generated at the POCT Site Be same cutoff concentrations for its initial drug and validity test results when Retained? drug tests as listed for a hair sample in requested by the Secretary. section 3.3, for an oral fluid specimen All records must be retained for at (d) The Federal agency must make in section 3.4, for a sweat patch sample least 2 years by the POCT tester or the available the POCT tester to testify in a in section 3.5, and for a urine specimen tester’s employer. proceeding against a Federal employee in section 3.6. Section 12.24 What POCT Information when that proceeding is based on a test result that begins with a POCT. Section 13.4 What Must Be Included in Is Available to the Donor? the HHS-Certified IITF’s Standard (a) An employee tested by a Federal Section 12.26 What Type of Operating Procedure Manual? Relationship Is Prohibited Between a agency workplace drug testing program (a) An HHS-certified IITF must have Manufacturer of a POCT Device or a may, upon written request through the a standard operating procedure (SOP) POCT Site Operation and an MRO? MRO and the Federal agency, have manual that describes, in detail, all IITF access to any records relating to his or (a) An MRO must not be an employee, operations. her drug test, any records relating to the agent of, or have any financial interest (b) The SOP manual must include, but results of any relevant review of the in a manufacturer of a POCT device or is not limited to, a detailed description POCT, and have access to a POCT site operation for which the MRO of the following: documentation package. is reviewing drug test results. (1) Chain-of-custody procedures; (b) The documentation package must (b) An MRO must not derive any (2) Accessioning; contain the following: financial benefit by having an agency (3) Security;

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(4) Quality control/quality assurance whenever procedures are first placed (d) When a new RT candidate has programs; into use or changed or when a new been identified, the IITF must submit to (5) Analytical methods and individual assumes responsibility for the Secretary the candidate’s current procedures; management of the IITF. resume or curriculum vitae, arrange to (6) Equipment and maintenance (d) Verify and maintain a quality have official academic transcript(s) programs; assurance program to assure the proper submitted by the candidate’s (7) Personnel training; performance and reporting of all test institution(s) of higher learning, copies (8) Reporting procedures; and results; monitor acceptable analytical of diplomas and any licensures, a (9) Computers, software, laboratory performance for all controls and training plan (not to exceed 90 days) to information management systems. standards; monitor quality control transition into the RT position, and an (c) All procedures in the SOP manual testing; document the validity, itemized defense of the candidate’s must be in compliance with these reliability, accuracy, precision, and qualifications compared to the Guidelines and other guidance performance characteristics of each minimum RT qualifications described in documents. device/system used at that testing the Guidelines. (d) A copy of all procedures that have facility. (e) The HHS-certified IITF must fulfill been replaced or revised and the dates (e) Implement all remedial actions other inspection and PT criteria as on which they were in effect must be necessary to maintain satisfactory required prior to conducting Federal maintained by the HHS-certified IITF to operation and performance of the testing agency testing under a new RT. allow the IITF to retrieve the procedures facility in response to quality control that were used to test a specimen. systems not being within performance Section 13.9 What Qualifications Must specifications, errors in result reporting an Individual Have To Certify a Test Section 13.5 What Must the HHS- or in analysis of performance testing Result Reported By an HHS-Certified Certified IITF Do To Validate an Initial results. This individual must ensure IITF? Drug Test? that sample results are not reported The individual who certifies a The HHS-certified IITF must satisfy until all corrective actions have been negative test result must have: the same validation requirements as taken and he or she can assure that the (a) Training and experience in the described in section 11.13. results provided are accurate and analytical methods and procedures used Section 13.6 What Qualifications Must reliable. by the IITF that are relevant to the the Responsible Technician (RT) Have? (f) Qualify as an operator of the initial results that the individual certifies; and test analyzers used at the IITF. (b) Training and experience in An RT must have the following reviewing and reporting test results, Section 13.8 What Happens When the qualifications: maintenance of chain of custody, and RT Is Absent or Leaves an HHS-Certified (a) A bachelor’s degree in the understanding proper remedial action in IITF? chemical or biological sciences, medical response to problems that may arise. technology, or similar field; (a) All HHS-certified IITFs must have (b) Training and experience in the an RT and an alternate RT. An alternate Section 13.10 What Qualifications and analytical methods and procedures used RT must be able to fulfill the Training Must Other IITF Personnel by the IITF that are relevant to the responsibilities of an RT and must meet Have? results; the qualifications of a certifying (a) All IITF staff (e.g., technicians, (c) Training and experience in scientist. The laboratory must submit administrative staff) must have the reviewing and reporting test results, documentation satisfactory to the appropriate training and skills for the maintenance of chain of custody, Secretary which shows the credentials tasks assigned. recordkeeping, and understanding of the prospective RT and which must (b) Each individual working in an proper remedial action in response to be approved by the Secretary, and found HHS-certified IITF must be properly problems that may arise; and acceptable during on-site inspections of trained before he or she is permitted to (d) Be found to fulfill RT the IITF. work independently in any area of the responsibilities and qualifications upon (b) When the HHS-certified IITF is facility with Federal agency specimens. interview by HHS-trained inspectors without the RT and alternate RT for 14 (c) The training file for each during each on-site inspection of the calendar days or less (e.g., vacation, individual must include, at a minimum, HHS-certified IITF. illness, business trip), the certified IITF a resume, documentation of training may continue testing Federal agency provided, and any applicable Section 13.7 What Are the specimens under the direction of a professional certifications or licenses. Responsibilities of an RT? certifying scientist. Training files should be maintained An RT must: (c) When an RT permanently leaves a separate from personnel files. (a) Manage the day-to-day operations certified IITF: of the IITF. (1) The HHS-certified IITF may Section 13.11 What Security Measures (b) Ensure that there are enough maintain its certification and continue Must an HHS-Certified IITF Maintain? personnel with adequate training and testing Federal agency specimens under (a) An HHS-certified IITF must experience to conduct and operate the the direction of an alternate RT for a control access to the facility and ensure work of the IITF. The RT must ensure period of up to 180 days while seeking that no unauthorized individual can the continued competency of testing to hire and receive the Secretary’s gain access to specimens, aliquots, or facility personnel by documenting their approval of the new permanent RT. records. in-service training, reviewing their work (2) The Secretary, in accordance with (b) Authorized visitors must be performance, and verifying their skills. these Guidelines, will suspend an IITF’s escorted at all times except for (c) Maintain a complete, current SOP certification for all specimens if the IITF individuals authorized to conduct manual that is available for personnel at does not have a permanent replacement inspections on behalf of Federal, state, the IITF, and followed by those RT within 180 days. The suspension or other accrediting agencies or personnel. The SOP manual must be will be lifted upon the Secretary’s emergency personnel (e.g., firefighters reviewed, signed, and dated by the RT approval of the new permanent RT. and medical rescue teams).

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(c) An HHS-certified IITF must using chain of custody procedures to an procedures and any specimen validity maintain a record that documents the HHS-certified laboratory for tests performed on the donor’s dates, time of entry and exit, and confirmatory testing. specimen; purpose of entry of authorized visitors Section 13.16 How Long Must an HHS- (2) A table of contents page that lists and authorized escorts to accessing Certified IITF Retain Records? by page number all documents and secured areas. materials in the package; (a) An HHS-certified IITF must retain (3) A copy of the Federal CCF with Section 13.12 What Are the Internal all records generated to support test any attachments, internal chain of IITF Chain of Custody Requirements for results for at least 2 years. custody records for the specimen, a Specimen or an Aliquot? (b) A Federal agency may request the memoranda (if any) generated by the (a) An HHS-certified IITF must use HHS-certified IITF to maintain records IITF, and a copy of the electronic report chain of custody procedures to maintain associated with a particular specimen (if any) generated by the IITF; control and accountability of specimens under legal challenge for an indefinite from receipt through completion of period. (4) A brief description of the testing, reporting of results, during laboratory’s initial drug and validity test Section 13.17 What Statistical storage, and continuing until final procedures, instrumentation, batch Summary Report Must an HHS-Certified disposition of the specimens. quality control requirements, and copies (b) An HHS-certified IITF must use IITF Provide? of the initial test data for the donor’s chain of custody procedures to (a) An HHS-certified IITF must specimen with all calibrators and document the handling and transfer of provide to each Federal agency for controls identified and copies of all aliquots throughout the testing process which testing is conducted a internal chain of custody documents and until final disposal. semiannual statistical summary report related to the initial tests; and (c) The date and purpose must be that contains the following information: (5) A copy of the resume or documented on an appropriate chain of (1) Number of specimens tested curriculum vitae for the certifying custody document each time a specimen (2) The number grouped by reason for scientist that certified the test result. test as follows: or aliquot is handled or transferred, and Section 13.19 What Type of every individual in the chain must be (i) Random Relationship Is Prohibited Between an identified. (ii) All others reasons combined HHS-Certified IITF and an MRO? (d) Chain of custody must be (3) The number that were: maintained and documented by using (a) An MRO must not be an employee, (i) Screened positive for each drug either hard copy procedures or agent of, or have any financial interest (listed separately) electronic procedures. in an IITF for which the MRO is (ii) Screened as adulterated (e) Each individual that handles a (iii) Screened as substituted reviewing drug test results. specimen or aliquot must sign and (iv) Rejected for Testing (b) An MRO must not derive any complete the chain of custody (v) Invalid Result financial benefit by having an agency document when the specimen or aliquot use a specific instrumented initial test is received. (b) The report must be submitted by mail, fax, or e-mail within 14 working facility or have any agreement with the Section 13.13 What Are the Batch days after the end of the semiannual IITF that may be construed as a Quality Control Requirements When period. potential conflict of interest. Conducting the Initial Tests for Drugs? (c) The HHS-certified IITF must make Section 13.20 What Type of The HHS-certified IITF must satisfy available copies of an agency’s test Relationship Can Exist Between an the same quality control requirements as results when requested by the Secretary HHS-Certified IITF and an HHS- described in section 11.14 for an HHS- or by the Federal agency for which the Certified Laboratory? certified laboratory. IITF is performing drug-testing services. (d) The HHS-certified IITF must make An HHS-certified IITF can freely enter Section 13.14 What Are the Analytical available qualified personnel to testify into any relationship with an HHS- and Quality Control Requirements for in a proceeding against a Federal certified laboratory. Conducting Initial Validity Tests? employee when that proceeding is based Section 13.21 How Does an HHS- An HHS-certified IITF must satisfy on a test result reported by the HHS- Certified IITF Report a Negative Test the same initial validity test certified IITF. Result? requirements described in sections Section 13.18 What IITF Information Is (a) An HHS-certified IITF may 11.18, 11.19, 11.20, and 11.21 and Available to the Donor? sections 11.22, 11.23, 11.24, and 11.25 transmit a result to the MRO by various for each type of specimen, as (a) An employee tested by a Federal electronic means (for example, appropriate. agency workplace drug testing program teleprinters, facsimile, or computer) in a may, upon written request through the manner designed to ensure Section 13.15 What Action Is Taken MRO and the Federal agency, have confidentiality of the information. A After an HHS-Certified IITF Tests a access to any records relating to his or result may not be reported verbally by Specimen? her drug test, any records relating to the telephone. An IITF must ensure the (a) A specimen that is negative on results of any relevant certification, security of the data transmission and initial drug tests and has acceptable review, or revocation of certification limit access to any data transmission, initial validity test results is discarded proceedings, and access to a storage, and retrieval system. and reported as negative to the MRO documentation package. (b) For all test results, an HHS- within 3 days (on average) working days (b) A standard documentation certified IITF may fax, courier, mail, or after receipt of the specimen. package provided by an HHS-certified electronically transmit a legible image (b) A specimen that is presumptive IITF must contain the following items: or copy of the completed Federal CCF, drug positive, adulterated, substituted, (1) A cover sheet that provides a brief and/or forward a computer-generated or invalid is immediately forwarded description of the drug testing electronic report.

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Section 13.22 How Does an HHS- (a) The collection procedures for each to test to the agency because the Certified IITF Handle a Specimen That type of specimen collected; specimen was adulterated. Is Presumptive Drug Positive, (b) The procedures for conducting (d) When an HHS-certified laboratory Adulterated, Substituted, or Invalid? POCT tests; or IITF reports an invalid result on the (c) How to interpret test results primary (Sample A) head hair sample, (a) The remaining specimen is reported by laboratories; the MRO contacts the donor to resealed using a tamper-evident label/ (d) Chain of custody, reporting, and determine if there is a valid medical seal; recordkeeping requirements for explanation for the invalid result. If the (b) The individual resealing the regulated specimens; and donor is unable to provide an remaining specimen initials and dates (e) The HHS Mandatory Guidelines explanation, the MRO reports a test the tamper-evident label/seal; for Federal Workplace Drug Testing cancelled result and directs the agency (c) The resealed specimen and split Programs. to collect another specimen from the specimen are sent to an HHS-certified donor. If the second specimen collected laboratory for confirmatory testing Section 14.3 What Are the exhibits the same behavior as the first within one day after completing the Responsibilities of the MRO? specimen, the MRO again reports the initial drug and/or validity tests; and (a) The MRO must: result for the second specimen as test (d) The HHS-certified IITF provides (1) Review the information on the cancelled and recommends to the the test result(s) on the OMB-approved MRO copy of the Federal CCF that was agency that no further action is chain of custody form used to report received from the collector and the required. initial test results. report received from the HHS-certified (e) When an HHS-certified laboratory Section 13.23 Where Is the List of laboratory, HHS-certified IITF, or POCT or IITF reports a rejected for testing HHS-Certified IITFs Published? site; result (e.g., lice) on the primary (Sample (2) Interview the donor when A) head hair sample, the MRO reports (a) The list of current HHS-certified required; a test cancelled result to the agency and IITFs is published monthly in the (3) Make a determination regarding directs the agency to collect another Federal Register. the test result; sample from the donor. (b) An applicant IITF is not included (4) Report the verified result to the on the list. Federal agency; and Section 14.5 What Must an MRO Do When Reviewing an Oral Fluid Test Subpart N—Medical Review Officer (5) Maintain the records (for a Result? (MRO) minimum of 2 years) and the confidentiality of the information. (a) When a HHS-certified laboratory, Section 14.1 Who May Serve as an (b) The review of a non-negative test HHS-certified IITF, or POCT tester MRO? result must be performed by the MRO reports a negative result on the primary (a) A licensed physician who: before the result is transmitted to the (Tube A) oral fluid specimen, the MRO (1) Has either a Doctor of Medicine agency’s designated representative. Staff reports a negative result to the agency. (M.D.) or Doctor of Osteopathy (D.O.) under the direct, personal supervision (b) When an HHS-certified laboratory degree; of the MRO may review and report a reports a positive result on the primary (2) Has knowledge regarding the negative test result to the agency’s (Tube A) oral fluid specimen, the MRO pharmacology and toxicology of illicit designated representative. The MRO contacts the donor to determine if there drugs; must cancel the result for any agency’s is any valid medical explanation for the (3) Has the training necessary to serve specimen that is not collected or tested positive result. If the donor provides a as an MRO as set out in section 14.2; in accordance with these Guidelines. valid medical explanation, the MRO and reports the test result as negative to the (4) Has satisfactorily completed an Section 14.4 What Must an MRO Do agency. If the donor is unable to provide examination administered by a When Reviewing a Hair Test Result? a valid medical explanation, the MRO nationally recognized entity that (a) When the HHS-certified laboratory reports a positive result to the agency. certifies MROs or subspecialty board for or IITF reports a negative result on the (c) When an HHS-certified laboratory physicians performing a review of primary (Sample A) head hair sample, reports an adulterated or substituted Federal employee drug test results, the MRO reports a negative result to the result on the primary (Tube A) oral fluid which has been approved by the agency. specimen, the MRO contacts the donor Secretary. (b) When the HHS-certified laboratory to determine if there is a valid (b) Nationally recognized entities that reports a positive result on the primary explanation for the adulterated or certify MROs or subspecialty boards for (Sample A) head hair sample, the MRO substituted result. If the donor is unable physicians performing a review of contacts the donor to determine if there to provide a valid explanation, the MRO Federal employee drug test results that is any valid medical explanation for the reports a refusal to test to the agency seek approval by the Secretary must positive result. If the donor provides a because the specimen was adulterated submit their qualifications and sample valid medical explanation, the MRO or substituted. examination. Based on an annual reports the test result as negative to the (d) When an HHS-certified laboratory objective review of the qualifications agency. If the donor is unable to provide or IITF reports an invalid result on the and content of the examination, the a valid medical explanation, the MRO primary (Tube A) oral fluid specimen, Secretary shall annually publish a list in reports a positive result to the agency. the MRO contacts the donor to the Federal Register of those entities (c) When an HHS-certified laboratory determine if there is a valid explanation and boards that have been approved. reports an adulterated result on the for the invalid result. If the donor is primary (Sample A) head hair sample, unable to provide an explanation, the Section 14.2 What Are the Training the MRO contacts the donor to MRO reports a test cancelled result and Requirements Before a Physician Can determine if there is a valid medical directs the agency to collect another Serve as an MRO? explanation for the adulterated result. If specimen from the donor. If the second A physician must receive training that the donor is unable to provide a valid specimen collected exhibits the same includes a thorough review of: explanation, the MRO reports a refusal behavior as the first specimen, the MRO

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again reports the result for the second Section 14.7 What Must an MRO Do result on the primary (Bottle A) urine specimen as test cancelled and When Reviewing a Urine Test Result? specimen, the MRO contacts the donor recommends to the agency that no (a) When an HHS-certified laboratory, to determine if there is a valid medical further action is required. HHS-certified IITF, or POCT tester explanation for the adulterated or (e) When an HHS-certified laboratory reports a negative result on the primary substituted result. If the donor is unable or IITF reports a rejected for testing (Bottle A) urine specimen, the MRO to provide a valid medical explanation, result on the primary (Tube A) oral fluid reports a negative result to the agency. the MRO reports a refusal to test to the specimen, the MRO reports a test (b) When an HHS-certified laboratory, agency because the specimen was cancelled result to the agency and HHS-certified IITF, or POCT tester adulterated or substituted. directs the agency to collect another reports a negative and dilute result on (f) When an HHS-certified laboratory specimen from the donor. the primary (Bottle A) urine specimen, or IITF reports an invalid result on the the MRO contacts the donor to primary (Bottle A) urine specimen, the Section 14.6 What Must an MRO Do determine if there is any possible MRO contacts the donor to determine if When Reviewing a Sweat Patch Test explanation for the urine specimen there is a valid medical explanation for Result? being dilute. If there appears to be a the invalid result. If the donor is unable legitimate medical explanation, the (a) When an HHS-certified laboratory to provide an explanation, provides a MRO reports a negative result to the valid prescription for some medications or IITF reports a negative result on the agency without indicating that the primary (Patch A) sweat patch sample, (e.g., Tolmetin, Flagyl, Cipro), or denies specimen was dilute. If there is no having tampered with the specimen, the the MRO reports a negative result to the legitimate medical explanation, the agency. MRO reports a test cancelled result and MRO directs the agency to immediately directs the agency to collect another (b) When an HHS-certified laboratory collect another specimen from the specimen from the donor using a direct reports a positive result on the primary donor. observed collection. If the second (c) When an HHS-certified laboratory (Patch A) sweat patch sample, the MRO specimen collected using a direct reports a positive result on the primary contacts the donor to determine if there observed collection procedure exhibits (Bottle A) urine specimen, the MRO is any valid medical explanation for the the same behavior as the first specimen, contacts the donor to determine if there positive result. If the donor provides a the MRO again reports the result for the valid medical explanation, the MRO is any valid medical explanation for the positive result. If the donor provides a second specimen as test cancelled and reports the test result as negative to the recommends to the agency that no agency. If the donor is unable to provide valid medical explanation, the MRO reports the test result as negative to the further action is required because the a valid medical explanation, the MRO donor is taking a valid prescription reports a positive result to the agency. agency. If the donor is unable to provide a valid medical explanation, the MRO medication that interferes with the drug (c) When an HHS-certified laboratory reports a positive result to the agency. test or there is some unknown reports an adulterated result on the If a laboratory also reports that the endogenous substance present in the primary (Patch A) sweat patch sample, specimen is dilute, the MRO directs the donor’s urine that prevents getting a the MRO contacts the donor to agency to have the donor provide valid drug test result. determine if there is a valid explanation another specimen using a direct (g) When an HHS-certified laboratory for the adulterated result. If the donor is observed collection procedure (when or IITF reports a rejected for testing unable to provide a valid explanation, the MRO was reporting the result as result on the primary (Bottle A) urine the MRP reports a refusal to test to the negative). For a positive result, the MRO specimen, the MRO reports a test agency because the specimen was may ignore the dilute result. cancelled result to the agency and adulterated. (d) When an HHS-certified laboratory directs the agency to immediately (d) When an HHS-certified laboratory reports a positive result for opiates on collect another specimen from the or IITF reports an invalid result on the the primary (Bottle A) urine specimen, donor. primary (Patch A) sweat patch sample, the MRO must determine that there is Section 14.8 Who May Request a Test the MRO contacts the donor to clinical evidence in addition to the of a Split Specimen? determine if there is a valid explanation urine test result of illegal use of any opium, opiate, or opium derivative (e.g., for the invalid result. If the donor is (a) For a positive, adulterated, or morphine/codeine) listed in Schedule I unable to provide an explanation, the substituted result reported on a primary or II of the Controlled Substances Act. MRO reports a test cancelled result and specimen, a donor may request through However, this requirement does not directs the agency to collect another the MRO that the split specimen be apply if the laboratory confirms the specimen from the donor. If the second tested by a second HHS-certified presence of 6-acetylmorphine (i.e., the specimen collected using a direct laboratory to verify the result reported presence of this metabolite is proof of observed collection procedure exhibits by the first laboratory. the same behavior as the first specimen, heroin use) or the morphine or codeine concentration is greater than or equal to (b) The donor has 72 hours (from the the MRO again reports the result for the 15,000 ng/mL and the donor does not time the MRO notified the donor that second specimen as test cancelled and present a legitimate medical explanation his or her specimen was reported recommends to the agency that no for the presence of morphine or codeine positive, adulterated, or substituted) to further action is required. at or above this concentration. request a test of the split specimen. The (e) When an HHS-certified laboratory Consumption of food products must not MRO must inform the donor that he or or IITF reports a rejected for testing be considered a legitimate medical she has the right to request a test of the result on the primary (Patch A) sweat explanation for the donor having split specimen when the MRO informs patch sample, the MRO reports a test morphine or codeine at or above this the donor that a positive, adulterated, or cancelled result to the agency and concentration. substituted result is being reported to directs the agency to collect another (e) When an HHS-certified laboratory the Federal agency on the primary sample. reports an adulterated or substituted specimen.

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Section 14.9 How Does the MRO positive, adulterated, or substituted Section 15.5 How Does an HHS- Report a Primary Specimen Test Result result. Certified Laboratory Test a Split Sweat to an Agency? Patch Sample for Adulterants When the Section 15.2 How Does an HHS- Primary Sample Was Reported (a) The MRO must report all verified Certified Laboratory Test a Split Hair, Adulterated? results to an agency by either faxing a Oral Fluid, Sweat, or Urine Specimen completed MRO copy of the Federal When the Primary Specimen Was (a) The second laboratory must test CCF, transmitting a scanned image of Reported Positive? the split sweat patch sample using the laboratory’s confirmatory test(s) for the the completed MRO copy of the Federal (a) The testing of a split head hair, CCF, or faxing a separate report using a adulterant(s) reported in the primary oral fluid, sweat, or urine specimen for sample. letter/memorandum format. a drug or metabolite is not subject to the (b) A verified result may not be (b) The second laboratory is only testing cutoff concentrations established required to confirm the presence of the reported to the agency until the MRO for each type of specimen collected. has completed the review process. adulterant(s) using the limit of detection (b) The laboratory is only required to (LOD) of its confirmatory test(s). (c) The MRO must send a hard copy confirm the presence of the drug or of either the completed MRO copy of (c) The second laboratory may only metabolite that was reported present in conduct the confirmatory test(s) needed the Federal CCF or the separate letter/ the primary head hair, oral fluid, sweat, memorandum report for all non- to reconfirm the adulterant(s) reported or urine specimen. by the primary laboratory. negative results. (c) For urine only, if the second (d) The MRO must not disclose laboratory fails to reconfirm the Section 15.6 How Does an HHS- numerical values to the Federal agency. presence of the drug or drug metabolite Certified Laboratory Test a Split Urine Specimen for Adulterants When the Section 14.10 What Type of that was reported by the first laboratory, Primary Specimen Was Reported Relationship Is Prohibited Between an the second laboratory must conduct Adulterated? MRO and an HHS-Certified Laboratory, validity tests in an attempt to determine POCT Tester, or an HHS-Certified IITF? the reason for being unable to reconfirm (a) A laboratory must use one of the the presence of the drug or drug following criteria to reconfirm an (a) An MRO must not be an employee, metabolite. The second laboratory adulterated result when testing a split agent of, or have any financial interest should conduct the same validity tests (Bottle B) specimen: in an HHS-certified laboratory, POCT as it would conduct on a primary (1) pH must be measured using the tester, or HHS-certified IITF for which specimen and reports those results to laboratory’s confirmatory pH test with the MRO is reviewing drug test results. the MRO. the appropriate cutoff (i.e., either less (b) An MRO must not derive any Section 15.3 How Does an HHS- than 3 or greater than or equal to 11); financial benefit by having an agency (2) Nitrite must be measured using the Certified Laboratory Test a Split Hair use a specific HHS-certified laboratory, laboratory’s confirmatory nitrite test Sample for Adulterants When the POCT tester, or HHS-certified IITF or with a cutoff concentration of greater Primary Sample Was Reported have any agreement with the laboratory, than or equal to 500 mcg/mL; or Adulterated? POCT tester, or IITF that may be (3) For adulterants without a specified construed as a potential conflict of (a) The second laboratory must test cutoff (e.g., glutaraldehyde, surfactant, interest. the split head hair sample using the chromium (VI), pyridine, halogens (such laboratory’s confirmatory test(s) for the Subpart O—Split Specimen Tests as bleach, iodine), peroxidase, peroxide, adulterant(s) reported in the primary other oxidizing agents), the laboratory Section 15.1 When May a Split sample. must use its confirmatory validity test at Specimen Be Tested? (b) The second laboratory is only an established limit of detection (LOD) required to confirm the presence of the to reconfirm the presence of the (a) A donor has the right to request adulterant(s) using the limit of detection through the MRO that the split adulterant. (LOD) of its confirmatory test(s). (b) The second laboratory may only specimen be tested at a different HHS- (c) The second laboratory may only conduct the confirmatory validity test(s) certified laboratory when the primary conduct the confirmatory test(s) needed needed to reconfirm the adulterant specimen was determined by the MRO to reconfirm the adulterant(s) reported result reported by the primary to be positive, adulterated, or by the primary laboratory. laboratory. substituted (as appropriate for each type of specimen collected). Section 15.4 How Does an HHS- Section 15.7 How Does an HHS- (b) A donor has 72 hours to initiate Certified Laboratory Test a Split Oral Certified Laboratory Test a Split Oral the request after being informed of the Fluid Specimen for Adulterants When Fluid Specimen for Substitution When result by the MRO. The donor must the Primary Specimen Was Reported the Primary Specimen Was Reported document this request in writing to the Adulterated? Substituted? MRO. (a) The second laboratory must test The second laboratory must test the (c) If the split specimen cannot be the split oral fluid specimen using the split (Tube B) specimen using the tested by a second laboratory (e.g., laboratory’s confirmatory test(s) for the laboratory’s confirmatory IgG test and insufficient specimen, lost in transit, adulterant(s) reported in the primary determine that the IgG concentration is split not available), the MRO shall direct specimen. less than 0.10 mcg/mL. the Federal agency to immediately (b) The second laboratory is only collect another specimen. required to confirm the presence of the Section 15.8 How Does an HHS- (d) If a donor chooses not have the adulterant(s) using the limit of detection Certified Laboratory Test a Split Urine split specimen tested by a second HHS- (LOD) of its confirmatory test(s). Specimen for Substitution When the certified laboratory, a Federal agency (c) The second laboratory may only Primary Specimen Was Reported may have a split specimen retested as conduct the confirmatory test(s) needed Substituted? part of a legal or administrative to reconfirm the adulterant(s) reported (a) A laboratory must use the proceeding to defend an original by the primary laboratory. following criteria to reconfirm a

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substituted result when testing a split cancels both tests, and notifies the HHS explanation for the adulteration result, (Bottle B) specimen: office responsible for coordination of the MRO reports a failed to reconfirm (1) The creatinine must be measured the drug-free workplace program. (specify drug(s)) and cancels both tests. using the laboratory’s confirmatory (c) Failed to reconfirm one or more If there is no legitimate medical creatinine test with a cutoff drugs, reconfirmed one or more drugs. explanation, the MRO reports a failed to concentration of less than 2 mg/dL; and The MRO reports to the agency a failed reconfirm (specify drug(s)) and a refusal (2) The specific gravity must be to reconfirm result (specify drug(s)) and to test to the agency and indicates the measured using the laboratory’s a reconfirmed result (specify drug(s)). adulterant that is present in the urine confirmatory specific gravity test with The MRO tells the agency that it may specimen. The MRO gives the donor 72 the specified cutoffs of less than 1.0010 take action based on the reconfirmed hours to request that Laboratory A retest or greater than or equal to 1.0200. drug(s) although the second laboratory the primary specimen for the adulterant. (b) The second laboratory may only failed to reconfirm one or more drugs. If Laboratory A reconfirms the conduct the confirmatory validity test(s) (d) Failed to reconfirm the adulterant, the MRO reports refusal to needed to reconfirm the validity test adulteration or substitution result. The test and indicates the adulterant result(s) reported by the primary MRO reports to the agency a failed to present. If Laboratory A fails to laboratory. reconfirm result (specify not adulterated reconfirm the adulterant, the MRO or substituted), cancels both tests, and cancels both tests and directs the agency Section 15.9 Who Receives the Split notifies the HHS office responsible for to immediately collect another Specimen Result? coordination of the drug-free workplace specimen using a direct observed The second laboratory must transmit program. collection procedure. The MRO shall the result directly to the MRO. notify the appropriate regulatory office Section 15.12 What Action(s) Does the about the failed to reconfirm and Section 15.10 What Action(s) Does the MRO Take After Receiving the Split MRO Take After Receiving the Split Hair cancelled test. Sweat Patch Sample Result From the (c) Failed to reconfirm a single or all Sample Result From the Second Second Laboratory? drug positive results and substituted. If Laboratory? The MRO takes the following actions the donor provides a legitimate medical The MRO takes the following actions when the second laboratory reports the explanation for the substituted result, when the second laboratory reports the result for the split sweat patch sample the MRO reports a failed to reconfirm result for the split head hair sample as: as: (specify drug(s)) and cancels both tests. (a) Reconfirmed the drug(s). The MRO (a) Reconfirmed the drug(s) and/or If there is no legitimate medical reports reconfirmed to the agency. adulteration result. The MRO reports explanation, the MRO reports a failed to (b) Failed to reconfirm the drug(s). reconfirmed to the agency. reconfirm (specify drug(s)) and a refusal The MRO reports to the agency a failed (b) Failed to reconfirm the drug(s). to test (substituted) to the agency. The to reconfirm result (specify drug(s)), The MRO reports to the agency a failed MRO gives the donor 72 hours to cancels both tests, and notifies the HHS to reconfirm result (specify drug(s)), request Laboratory A to review the office responsible for coordination of cancels both tests, and notifies the HHS creatinine and specific gravity results the drug-free workplace program. office responsible for coordination of for the primary specimen. If the original (c) Failed to reconfirm one or more the drug-free workplace program. creatinine and specific gravity results drugs, reconfirmed one or more drugs. (c) Failed to reconfirm one or more confirm that the specimen was The MRO reports to the agency a failed drugs, reconfirmed one or more drugs. substituted, the MRO reports a refusal to to reconfirm result (specify drug(s)) and The MRO reports to the agency a failed test (substituted) to the agency. If the a reconfirmed result (specify drug(s)). to reconfirm result (specify drug(s)) and original creatinine and specific gravity The MRO tells the agency that it may a reconfirmed result (specify drug(s)). results from Laboratory A fail to confirm take action based on the reconfirmed The MRO tells the agency that it may that the specimen was substituted, the drug(s) although the second laboratory action based on the reconfirmed drug(s) MRO cancels both tests and directs the failed to reconfirm one or more drugs. although the second laboratory failed to agency to immediately collect another (d) Failed to reconfirm the reconfirm one or more drugs. specimen using a direct observed adulteration result. The MRO reports to (d) Failed to reconfirm the collection procedure. The MRO shall the agency a failed to reconfirm result adulteration result. The MRO reports to notify the HHS office responsible for (specify not adulterated), cancels both the agency a failed to reconfirm result coordination of the drug-free workplace tests, and notifies the HHS office (specify not adulterated), cancels both program about the failed to reconfirm responsible for coordination of the drug- tests, and notifies the HHS office and cancelled test. free workplace program. responsible for coordination of the drug- (d) Failed to reconfirm a single or all free workplace program. drug positive results and not Section 15.11 What Action(s) Does the adulterated or substituted. The MRO MRO Take After Receiving the Split Oral Section 15.13 What Action(s) Does the reports to the agency a failed to Fluid Specimen Result From the Second MRO Take After Receiving the Split reconfirm result (specify drug(s)), Laboratory? Urine Specimen Result From the Second cancels both tests, and notifies the HHS The MRO takes the following actions Laboratory? office responsible for coordination of when the second laboratory reports the The MRO takes the following actions the drug-free workplace program. result for the split oral fluid specimen when the second laboratory reports the (e) Failed to reconfirm a single or all as: result for the split urine specimen as: drug positive results and invalid result. (a) Reconfirmed the drug(s), (a) Reconfirmed the drug(s), The MRO reports to the agency a failed adulteration, and/or substitution result. adulteration, and/or substitution result. to reconfirm result (specify drug(s) and The MRO reports reconfirmed to the The MRO reports reconfirmed to the gives the reason for the invalid result), agency. agency. cancels both tests, directs the agency to (b) Failed to reconfirm the drug(s). (b) Failed to reconfirm a single or all immediately collect another specimen The MRO reports to the agency a failed drug positive results and adulterated. If using a direct observed collection to reconfirm result (specify drug(s)), the donor provides a legitimate medical procedure, and notifies the HHS office

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responsible for coordination of the drug- program regarding the test results for the failed to reconfirm result (not free workplace program. specimen. substituted). The MRO tells the agency (f) Failed to reconfirm one or more (k) Failed to reconfirm a single or all that it may take action based on the drugs, reconfirmed one or more drugs, drug positive results and reconfirmed an adulterated result although Laboratory B and adulterated. The MRO reports to adulterated or substituted result. The failed to reconfirm the substituted the agency a reconfirmed result (specify MRO reports to the agency a result. drug(s)) and a failed to reconfirm result reconfirmed result (adulterated or Section 15.14 How Does an MRO (specify drug(s)). The MRO tells the substituted) and a failed to reconfirm Report a Split Specimen Test Result to agency that it may take action based on result (specify drug(s)). The MRO tells an Agency? the reconfirmed drug(s) although the agency that it may take action based Laboratory B failed to reconfirm one or on the reconfirmed result (adulterated (a) The MRO must report all verified more drugs and found that the specimen or substituted) although Laboratory B results to an agency by either faxing a was adulterated. The MRO shall notify failed to reconfirm the drug(s) result. completed MRO copy of the Federal the HHS office official responsible for (l) Failed to reconfirm a single or all CCF, transmitting a scanned image of coordination of the drug-free workplace drug positive results and failed to the completed MRO copy of the Federal program regarding the test results for the reconfirm the adulterated or substituted CCF, or faxing a separate report using a specimen. result. The MRO reports to the agency letter/memorandum format. (g) Failed to reconfirm one or more a failed to reconfirm result (specify (b) A verified result may not be drugs, reconfirmed one or more drugs, drug(s) and specify adulterant or reported to the agency until the MRO and substituted. The MRO reports to the substituted) and cancels both tests. The has completed the review process. agency a reconfirmed result (specify MRO shall notify the HHS office (c) The MRO must send a hard copy drug(s)) and a failed to reconfirm result responsible for coordination of the drug- of either the completed MRO copy of (specify drug(s)). The MRO tells the free workplace program regarding the the Federal CCF or the separate letter/ test results for the specimen. agency that it may take action based on memorandum report for all non- (m) Failed to reconfirm at least one the reconfirmed drug(s) although negative results. drug and reconfirmed the adulterated Laboratory B failed to reconfirm one or (d) The MRO must not disclose result. The MRO reports to the agency numerical values to the agency. more drugs and found that the specimen a reconfirmed result (specify drug(s) and was substituted. The MRO shall notify adulterated) and a failed to reconfirm Section 15.15 How Long Must an HHS- the HHS office responsible for result (specify drug(s)). The MRO tells Certified Laboratory Retain a Split coordination of the drug-free workplace the agency that it may take action based Specimen? program regarding the test results for the on the reconfirmed drug(s) and the specimen. A split specimen is retained for the adulterated result although Laboratory B same period of time that a primary (h) Failed to reconfirm one or more failed to reconfirm one or more drugs. drugs, reconfirmed one or more drugs, specimen is retained and under the (n) Failed to reconfirm at least one same storage conditions. This applies and not adulterated or substituted. The drug and failed to reconfirm the MRO reports a reconfirmed result even for those cases when the split adulterated result. The MRO reports to specimen is tested by a second (specify drug(s)) and a failed to the agency a reconfirmed result (specify reconfirm result (specify drug(s)). The laboratory and the second laboratory drug(s)) and a failed to reconfirm result does not confirm the original result MRO tells the agency that it may take (specify drug(s) and specify adulterant). action based on the reconfirmed drug(s) reported by the first laboratory on the The MRO tells the agency that it may primary specimen. although Laboratory B failed to take action based on the reconfirmed reconfirm one or more drugs. The MRO drug(s) although Laboratory B failed to Subpart P—Criteria for Rejecting a shall notify the HHS office responsible reconfirm one or more drugs and failed Specimen for Testing for coordination of the drug-free to reconfirm the adulterated result. Section 16.1 What Discrepancies workplace program regarding the test (o) Failed to reconfirm an adulterated results for the specimen. Require an HHS-Certified Laboratory or result and failed to reconfirm a IITF to Report a Hair, Oral Fluid, Sweat, (i) Failed to reconfirm one or more substituted result. The MRO reports to drugs, reconfirmed one or more drugs, or Urine Specimen as Rejected for the agency a failed to reconfirm result Testing? and invalid result. The MRO reports to ((specify adulterant) and not the agency a reconfirmed result (specify substituted) and cancels both tests. The The following discrepancies are drug(s)) and a failed to reconfirm result MRO shall notify the HHS office considered to be fatal flaws and the (specify drug(s)). The MRO tells the responsible for coordination of the drug- laboratory or IITF must stop the testing agency that it may take action based on free workplace program regarding the process, reject the specimen for testing, the reconfirmed drug(s) although test results for the specimen. and indicate the reason for rejecting the Laboratory B failed to reconfirm one or (p) Failed to reconfirm an adulterated specimen on the Federal CCF: more drugs and reported an invalid result and reconfirmed a substituted (a) The specimen ID number on the result. The MRO shall notify the HHS result. The MRO reports to the agency specimen label/seal does not match the office responsible for coordination of a reconfirmed result (substituted) and a ID number on the Federal CCF or the ID the drug-free workplace program failed to reconfirm result (specify number is missing either on the Federal regarding the test results for the adulterant). The MRO tells the agency CCF or on the specimen label/seal; specimen. that it may take action based on the (b) The specimen label/seal is broken (j) Failed to reconfirm substitution or substituted result although Laboratory B or shows evidence of tampering on the adulteration. The MRO reports to the failed to reconfirm the adulterated primary specimen and the split agency a failed to reconfirm result result. specimen cannot be re-designated as the (specify adulterant or not substituted) (q) Failed to reconfirm a substituted primary specimen; and cancels both tests. The MRO shall result and reconfirmed an adulterated (c) The collector’s printed name and notify the HHS office responsible for result. The MRO reports to the agency signature are omitted on the Federal coordination of the drug-free workplace a reconfirmed result (adulterated) and a CCF; or

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(d) There is an insufficient amount of (6) A phone number is missing/ (c) The above omissions and specimen/sample for analysis in the incorrect; discrepancies are considered primary specimen unless the split (7) A fax number is missing/incorrect; insignificant only when they occur no specimen can be re-designated as the (8) A ‘‘reason for test’’ box is not more than once a month. The primary specimen. marked; expectation is that each trained collector (e) For hair only, an HHS-certified (9) A ‘‘drug tests to be performed’’ box and HHS-certified laboratory and IITF laboratory or IITF may reject a head hair is not marked; will make every effort to ensure that the sample if it contains lice. (10) A specimen collection box is not Federal CCF is properly completed and marked; that all the information is correct. When Section 16.2 What Discrepancies (11) The observed box is not marked an error occurs more than once a month, Require an HHS-Certified Laboratory or (if applicable); the MRO must direct the collector, IITF to Report a Hair, Oral Fluid, Sweat, (12) The collection site address is laboratory, or IITF (whichever is or Urine Specimen as Rejected for missing; responsible for the error) to immediately Testing Unless the Problem is (13) The collector’s printed name is take corrective action to prevent the Corrected? missing but the collector’s signature is properly recorded; recurrence of the error. The following discrepancies are (14) The time of collection is not Section 16.4 What Discrepancies May considered to be correctable: indicated; Require an MRO To Cancel a Test? (a) If a collector failed to sign the (15) The date of collection is not Federal CCF, the laboratory or IITF must indicated; (a) An MRO must attempt to correct attempt to recover the collector’s (16) Incorrect name of delivery the following errors: signature before reporting the test result. service; (1) The donor’s signature is missing If the collector can provide a (17) The collector has changed or on the MRO copy of the Federal CCF memorandum for record recovering the corrected information by crossing out and the collector failed to provide a signature, the laboratory or IITF may the original information on either the comment that the donor refused to sign report the test result for the specimen. Federal CCF or specimen label/seal the form; If the laboratory or IITF cannot recover without dating and initialing the (2) The certifying scientist failed to the collector’s signature, the laboratory change; or sign the hard copy (Copy 1) of the or IITF must report a rejected for testing (18) The donor’s name inadvertently Federal CCF for a specimen being result and indicate the reason for the appears on the laboratory copy of the reported drug positive, adulterated, rejected for testing result on the Federal Federal CCF or on the tamper-evident substituted, rejected for testing, or CCF. labels used to seal the specimens. invalid test result (as appropriate for (b) If a specimen is submitted using a (19) For urine only, the collector each type of specimen collected); or non-Federal form or an expired Federal failed to check the specimen (3) The electronic report provided by CCF, the laboratory or IITF must test the temperature box and the ‘‘Remarks’’ line the HHS-certified laboratory or IITF specimen and also attempt to obtain a did not have a comment regarding the does not contain all the data elements memorandum for record explaining why temperature being out of range. If the required for the HHS standard a non-Federal form or an expired collector cannot provide a electronic laboratory or IITF report for a Federal CCF was used and ensure that memorandum for record (MFR) to attest specimen being reported drug positive, the form used contains all the required to the fact that he or she did measure adulterated, substituted, rejected for information. If the laboratory or IITF the specimen temperature, the testing, or invalid test result. cannot obtain a memorandum for record laboratory may report the test result for (b) If error (a)(1) occurs, the MRO from the collector, the laboratory or IITF the specimen but indicates that the must contact the collector to obtain a must report a rejected for testing result collector could not provide an MFR to statement to verify that the donor and indicate the reason for the rejected recover the omission. refused to sign the MRO copy. If the (b) The following omissions and for testing result on the report to the collector cannot provide such a discrepancies on the Federal CCF that MRO. statement, the MRO must cancel the are made at the laboratory or IITF are test. Section 16.3 What Discrepancies Are considered insignificant and should not (c) If error (a)(2) occurs, the MRO Not Sufficient To Require a Laboratory cause an MRO to cancel a test: must obtain a statement from the CS or IITF To Reject a Hair, Oral Fluid, (1) The testing laboratory or IITF fails that he or she inadvertently forgot to Sweat, or Urine Specimen for Testing or to indicate the correct name and address sign the CCF, but did, in fact, properly an MRO To Cancel a Test? in the results section when a different conduct the certification review. laboratory or IITF name and address is (a) The following omissions and (d) If error (a)(3) occurs, the MRO printed at the top of the Federal CCF; must contact the HHS-certified discrepancies on the Federal CCF that is (2) The accessioner fails to print his received by the HHS-certified laboratory laboratory or IITF and require the HHS- or her name; certified laboratory or IITF to modify its or IITF are considered insignificant and (3) The certifying scientist fails to electronic reports and to retransmit a should not cause an HHS-certified print his or her name; corrected electronic report. laboratory or IITF to reject a specimen (4) The certifying scientist or cause an MRO to cancel a test: accidentally initials the Federal CCF Subpart Q—Laboratory or IITF (1) An incorrect laboratory name and rather than providing a signature for a Suspension/Revocation Procedures address appears at the top of the form; non-negative result (CS initials are Section 17.1 When May an HHS- (2) Incomplete/incorrect/unreadable acceptable for a negative result); employer name or address; (5) The accessioner fails to mark one Certified Laboratory or IITF Be (3) MRO name is missing; of the ‘‘primary specimen bottle seal Suspended? (4) Incomplete/incorrect MRO intact’’ boxes, but the laboratory These procedures apply when: address; reported a ‘‘rejected for testing’’ result (a) The Secretary has notified an HHS- (5) A transposition of numbers in the with an appropriate comment on the certified laboratory or IITF in writing donor’s SSN; ‘‘Remarks’’ line. that its certification to perform drug

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testing under these Guidelines has been suspension or proposed revocation, a (b) Respondent’s Documents and suspended or that the Secretary brief statement of why the decision to Brief. Within 15 days after receiving a proposes to revoke such certification. suspend or propose revocation is wrong, copy of the acknowledgment of the (b) The HHS-certified laboratory or and the appellant’s request for an oral request for review, the respondent shall IITF has, within 30 days of the date of presentation, if desired. submit to the reviewing official the such notification or within 3 days of the (b) Within 5 days after receiving the following (with a copy to the appellant): date of such notification when seeking request for review, the reviewing official (1) A review file containing an expedited review of a suspension, will send an acknowledgment and documents supporting respondent’s requested in writing an opportunity for advise the appellant of the next steps. decision to suspend or revoke an informal review of the suspension or The reviewing official will also send a appellant’s certification to perform drug proposed revocation. copy of the acknowledgment to the and/or validity testing, tabbed and respondent. organized chronologically, and Section 17.2 What Definitions Are accompanied by an index identifying Used for This Subpart? Section 17.6 What Is an Abeyance Agreement? each document. Only essential Appellant. Means the HHS-certified documents should be submitted to the laboratory or IITF which has been Upon mutual agreement of the parties reviewing official. notified of its suspension or proposed to hold these procedures in abeyance, (2) A written statement, not exceeding revocation of its certification to perform the reviewing official will stay these 20 double-spaced pages in length, drug and/or validity testing and has procedures for a reasonable time while explaining the basis for suspension or requested an informal review thereof. the laboratory or IITF attempts to regain proposed revocation (respondent’s Respondent. Means the person or compliance with the Guidelines or the brief). persons designated by the Secretary in parties otherwise attempt to settle the (c) Reply Briefs. Within 5 days after implementing these Guidelines. dispute. As part of an abeyance receiving the opposing party’s Reviewing Official. Means the person agreement, the parties can agree to submission, or 20 days after receiving or persons designated by the Secretary extend the time period for requesting acknowledgment of the request for who will review the suspension or review of the suspension or proposed review, whichever is later, each party proposed revocation. The reviewing revocation. If abeyance begins after a may submit a short reply not to exceed official may be assisted by one or more request for review has been filed, the 10 double-spaced pages. of his or her employees or consultants appellant shall notify the reviewing (d) Cooperative Efforts. Whenever in assessing and weighing the scientific official at the end of the abeyance feasible, the parties should attempt to and technical evidence and other period advising whether the dispute has develop a joint review file. information submitted by the appellant been resolved. If the dispute has been (e) Excessive Documentation. The and respondent on the reasons for the resolved, the request for review will be reviewing official may take any suspension and proposed revocation. dismissed. If the dispute has not been appropriate step to reduce excessive resolved, the review procedures will documentation, including the return of Section 17.3 Are There Any Limitation begin at the point at which they were or refusal to consider documentation on Issues Subject To Review? interrupted by the abeyance agreement found to be irrelevant, redundant, or The scope of review shall be limited with such modifications to the unnecessary. to the facts relevant to any suspension procedures as the reviewing official Section 17.8 When Is There an or proposed revocation, the necessary deems appropriate. Opportunity for Oral Presentation? interpretations of those facts, the Mandatory Guidelines for Federal Section 17.7 What Procedure Is Used (a) Electing Oral Presentation. If an Workplace Drug Testing Programs, and To Prepare the Review File and Written opportunity for an oral presentation is other relevant law. The legal validity of Argument? desired, the appellant shall request it at these Guidelines shall not be subject to The appellant and the respondent the time it submits its written request review under these procedures. each participate in developing the file for review to the reviewing official. The for the reviewing official and in reviewing official will grant the request Section 17.4 Who Represents the submitting written arguments. The if the official determines that the Parties? procedures for development of the decision-making process will be The appellant’s request for review review file and submission of written substantially aided by oral presentations shall specify the name, address, and argument are: and arguments. The reviewing official phone number of the appellant’s (a) Appellant’s Documents and Brief. may also provide for an oral representative. In its first written Within 15 days after receiving the presentation at the official’s own submission to the reviewing official, the acknowledgment of the request for initiative or at the request of the respondent shall specify the name, review, the appellant shall submit to the respondent. address, and phone number of the reviewing official the following (with a (b) Presiding Official. The reviewing respondent’s representative. copy to the respondent): official or designee will be the presiding (1) A review file containing the official responsible for conducting the Section 17.5 When Must a Request for documents supporting appellant’s oral presentation. Informal Review Be Submitted? argument, tabbed and organized (c) Preliminary Conference. The (a) Within 30 days of the date of the chronologically, and accompanied by an presiding official may hold a prehearing notice of the suspension or proposed index identifying each document. Only conference (usually a telephone revocation, the appellant must submit a essential documents should be conference call) to consider any of the written request to the reviewing official submitted to the reviewing official. following: simplifying and clarifying seeking review, unless some other time (2) A written statement, not to exceed issues; stipulations and admissions; period is agreed to by the parties. A 20 double-spaced pages, explaining why limitations on evidence and witnesses copy must also be sent to the respondent’s decision to suspend or that will be presented at the hearing; respondent. The request for review must propose revocation of appellant’s time allotted for each witness and the include a copy of the notice of certification is wrong (appellant’s brief). hearing altogether; scheduling the

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hearing; and any other matter that will summary judgment. Except for those party’s position concerning the assist in the review process. Normally, made during the hearing, all motions suspension and any proposed this conference will be conducted and opposition to motions, including revocation. No reply brief is permitted. informally and off the record; however, argument, must be in writing and be no (d) Oral Presentation. If an oral the presiding official may, at his or her more than 10 double-spaced pages in presentation is requested by the discretion, produce a written document length. The presiding official will set a appellant or otherwise granted by the summarizing the conference or reasonable time for the party opposing reviewing official, the presiding official transcribe the conference, either of the motion to reply. will attempt to schedule the oral which will be made a part of the record. (5) Transcripts. The presiding official presentation within 7–10 days of the (d) Time and Place of Oral shall have the oral presentation date of appellant’s request for review at Presentation. The presiding official will transcribed and the transcript shall be a time and place determined by the attempt to schedule the oral made a part of the record. Either party presiding official following consultation presentation within 30 days of the date may request a copy of the transcript and with the parties. The presiding official appellant’s request for review is the requesting party shall be responsible received or within 10 days of for paying for its copy of the transcript. may hold a prehearing conference in submission of the last reply brief, (f) Obstruction of Justice or Making of accordance with section 17.8(c) and will whichever is later. The oral presentation False Statements. Obstruction of justice conduct the oral presentation in will be held at a time and place or the making of false statements by a accordance with the procedures of determined by the presiding official witness or any other person may be the sections 17.8(e), (f), and (g). following consultation with the parties. basis for a criminal prosecution under (e) Written Decision. The reviewing (e) Conduct of the Oral Presentation. 18 U.S.C. 1505 or 1001. official shall issue a written decision (1) General. The presiding official is (g) Post-hearing Procedures. At his or upholding or denying the suspension or responsible for conducting the oral her discretion, the presiding official proposed revocation and will attempt to presentation. The presiding official may may require or permit the parties to issue the decision within 7–10 days of be assisted by one or more of his or her submit post-hearing briefs or proposed the date of the oral presentation or employees or consultants in conducting findings and conclusions. Each party within 3 days of the date on which the the oral presentation and reviewing the may submit comments on any major transcript is received or the date of the evidence. While the oral presentation prejudicial errors in the transcript. last submission by either party, will be kept as informal as possible, the Section 17.9 Are There Expedited whichever is later. All other provisions presiding official may take all necessary set forth in section 17.14 will apply. steps to ensure an orderly proceeding. Procedures for Review of Immediate (2) Burden of Proof/Standard of Proof. Suspension? (f) Transmission of Written In all cases, the respondent bears the (a) Applicability. When the Secretary Communications. Because of the burden of proving by a preponderance notifies a laboratory or IITF in writing importance of timeliness for these of the evidence that its decision to that its certification to perform drug expedited procedures, all written suspend or propose revocation is and/or validity testing has been communications between the parties appropriate. The appellant, however, immediately suspended, the appellant and between either party and the has a responsibility to respond to the may request an expedited review of the reviewing official shall be by facsimile respondent’s allegations with evidence suspension and any proposed or overnight mail. and argument to show that the revocation. The appellant must submit Section 17.10 Are Any Types of respondent is wrong. this request in writing to the reviewing Communications Prohibited? (3) Admission of Evidence. The rules official within 3 days of the date the of evidence do not apply and the laboratory or IITF received notice of the Except for routine administrative and presiding official will generally admit suspension. The request for review must procedural matters, a party shall not all testimonial evidence unless it is include a copy of the suspension and communicate with the reviewing or clearly irrelevant, immaterial, or unduly any proposed revocation, a brief presiding official without notice to the repetitious. Each party may make an statement of why the decision to other party. opening and closing statement, may suspend and propose revocation is present witnesses as agreed upon in the wrong, and the appellant’s request for Section 17.11 How Are prehearing conference or otherwise, and an oral presentation, if desired. A copy Communications Transmitted by the may question the opposing party’s of the request for review must also be Reviewing Official? witnesses. Since the parties have ample sent to the respondent. opportunity to prepare the review file, (a) Because of the importance of a (b) Reviewing Official’s Response. As timely review, the reviewing official a party may introduce additional soon as practicable after the request for documentation during the oral should normally transmit written review is received, the reviewing official communications to either party by presentation only with the permission will send an acknowledgment with a of the presiding official. The presiding facsimile or overnight mail in which copy to the respondent. case the date of transmission or day official may question witnesses directly (c) Review File and Briefs. Within 7 following mailing will be considered the and take such other steps necessary to days of the date the request for review date of receipt. In the case of ensure an effective and efficient is received, but no later than 2 days communications sent by regular mail, consideration of the evidence, including before an oral presentation, each party the date of receipt will be considered 3 setting time limitations on direct and shall submit to the reviewing official the days after the date of mailing. cross-examinations. following: (4) Motions. The presiding official (1) A review file containing essential (b) In counting days, include may rule on motions including, for documents relevant to the review, Saturdays, Sundays, and holidays. example, motions to exclude or strike tabbed, indexed, and organized However, if a due date falls on a redundant or immaterial evidence, chronologically; and Saturday, Sunday, or Federal holiday, motions to dismiss the case for (2) A written statement, not to exceed then the due date is the next Federal insufficient evidence, or motions for 20 double-spaced pages, explaining the working day.

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Section 17.12 What Is the Authority submissions by the parties; transcripts immediately communicate the decision and Responsibilities of the Reviewing or other records of any meetings, to each party. Official? conference calls, or oral presentation; (c) Public Notice. If the suspension In addition to any other authority evidence submitted at the oral and proposed revocation are upheld, the specified in these procedures, the presentation; and orders and other revocation will become effective documents issued by the reviewing and reviewing official and the presiding immediately and the public will be presiding officials. official, with respect to those authorities notified by publication of a notice in the involving the oral presentation, shall Section 17.14 What Are the Federal Register. If the suspension and have the authority to issue orders; Requirements for a Written Decision? proposed revocation are denied, the examine witnesses; take all steps (a) Issuance of Decision. The revocation will not take effect and the necessary for the conduct of an orderly suspension will be lifted immediately. hearing; rule on requests and motions; reviewing official shall issue a written Public notice will be given by grant extensions of time for good decision upholding or denying the reasons; dismiss for failure to meet suspension or proposed revocation. The publication in the Federal Register. deadlines or other requirements; order decision will set forth the reasons for Section 17.15 Is There a Review of the the decision and describe the basis the parties to submit relevant Final Administrative Action? information or witnesses; remand a case therefor in the record. Furthermore, the for further action by the respondent; reviewing official may remand the Before any legal action is filed in waive or modify these procedures in a matter to the respondent for such court challenging the suspension or specific case, usually with notice to the further action as the reviewing official proposed revocation, respondent shall parties; reconsider a decision of the deems appropriate. exhaust administrative remedies reviewing official where a party (b) Date of Decision. The reviewing provided under this subpart, unless promptly alleges a clear error of fact or official will attempt to issue his or her otherwise provided by Federal Law. The law; and to take any other action decision within 15 days of the date of reviewing official’s decision, under the oral presentation, the date on which necessary to resolve disputes in section 17.9(e) or 17.14(a), constitutes the transcript is received, or the date of accordance with the objectives of these final agency action and is ripe for the last submission by either party, procedures. judicial review as of the date of the whichever is later. If there is no oral Section 17.13 What Administrative presentation, the decision will normally decision. Records Are Maintained? be issued within 15 days of the date of [FR Doc. 04–7984 Filed 4–6–04; 12:39 pm] The administrative record of review receipt of the last reply brief. Once BILLING CODE 4162–20–P consists of the review file; other issued, the reviewing official will

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