# Mandatory Guidelines for Federal Workplace Drug Testing Programs > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3AE8-26726 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** November 25, 2008 - **Citation:** 73 FR 71858 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs AGENCY: Substance Abuse and Mental Health Services Administration, HHS. ACTION: Revised Mandatory Guidelines. SUMMARY: This Final Notice of Revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Revisions to Mandatory Guidelines) addresses collection and testing of urine specimens, the requirements for the certification of Instrumented Initial Test Facilities (IITFs), and the role of and standards for collectors and Medical Review Officers (MROs). Additional notices of Proposed Revisions to the Mandatory Guidelines addressing the use of point of collection testing (POCT), oral fluid testing, sweat patch testing, hair testing, and associated issues will be published at a later date. With regard to the use of alternative specimens including hair, oral fluid, and sweat patch specimens in Federal Workplace Drug Testing Programs, significant issues have been raised by Federal agencies during the review process which require further examination, and may require additional study and analysis. As part of the review process for these alternative tests, the Department of Health and Human Services (“HHS” or “Department”) plans to issue a notice in the Federal Register requesting information and assistance from the general public to provide or identify data and research findings that address specific areas of interest. DATES: Effective Date: March 25, 2008. FOR FURTHER INFORMATION CONTACT: Donna M. Bush, Ph.D., Division of Workplace Programs, CSAP, SAMHSA, 1 Choke Cherry Road, Room 2-1033, Rockville, Maryland 20857, (240) 276-2600 (phone), (240) 276-2610 (Fax), or e-mail at donna.bush@samhsa.hhs.gov . SUPPLEMENTARY INFORMATION: Background The Guidelines were first published in the Federal Register on April 11, 1988, (53 FR 11970), and have since been revised in the Federal Register on June 9, 1994, (59 FR 29908), on September 30, 1997, (62 FR 51118), on November 13, 1998 (63 FR 63483), and on April 13, 2004, (69 FR 19644). The Guidelines establish the scientific and technical guidelines for Federal workplace drug testing programs and establish standards for certification of laboratories engaged in drug testing for Federal agencies under authority of section 503 of Public Law 100-71, 5 U.S.C. Section 7301 note, and Executive Order (E.O.) 12564. The Department also published Proposed Revisions to Mandatory Guidelines in the Federal Register on April 13, 2004, (69 FR 19673). These Proposed Revisions to Mandatory Guidelines described changing the Guidelines into a plain language format, expanding the Federal drug testing program to include use of alternative specimens including testing hair, oral fluid, and sweat patch specimens, allowing the use of “point of collection testing” (POCTs) for urine and oral fluid specimens, establishing the requirements for certifying “instrumented initial test facilities” (IITFs) to test specimens, and providing specific standards for collectors, POCT testers, and MROs. There was a 90-day public comment period during which 285 commenters submitted comments on the proposed changes to the Guidelines. These commenters were individuals and public and private entities. The comments are available for public view on the Department's Internet Web site ( http://workplace.samhsa.gov ). Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 note, required the Department to establish scientific and technical guidelines and amendments in accordance with Executive Order 12564, and to publish Mandatory Guidelines which establish comprehensive standards for all aspects of laboratory drug testing and procedures, including standards that require the use of the best available technology for ensuring the full reliability and accuracy of drug tests and strict procedures governing the chain of custody of specimens collected for drug testing. These revisions to the Mandatory Guidelines promote and establish standards that use the best available technology for ensuring the full reliability and accuracy of urine drug tests, while reflecting the ongoing process of review and evaluation of legal, scientific, and societal concerns. The submitted public comments and additional comments raised by Federal Agencies during subsequent internal review of the proposed changes to the Guidelines raised significant scientific, legal, and public policy concerns about the use of alternative specimens and POCT devices in Federal agency workplace drug testing programs. Since each alternative specimen and drug testing using POCT devices poses different concerns, the Department established a staggered timeline for issuing final guidance that allows for further study and research. In assessing the complexity of the task, the Department has decided to publish these final Guidelines with regard to collection and testing urine specimens, establishing the requirements for the certification of IITFs, and establishing specific standards for collectors and MROs. The Department considered several options for issuing one or more Final Notices in the Federal Register that may require additional public comment periods, concerning the use of alternative specimens and drug testing technologies such as POCT devices. Since the scientific, legal, and public policy information for drug testing oral fluid, hair, and sweat patch specimens, and using POCT devices is not as complete as it is for the laboratory-based urine drug testing program, developing Final Notices concerning the use of these is more challenging. As described in the notice of Proposed Revisions to Mandatory Guidelines issued April 13, 2004, the performance of alternative specimens in pilot performance testing (PT) programs has been encouraging, with individual laboratory and group performance improving over time. However, there are still three areas of concern. First, the data from the pilot PT programs to date show that not all participants have developed the capability to test for all required drug classes, nor to perform such tests with acceptable accuracy. Second, some drug classes are more difficult to detect than others, for any given type of specimen. Third, the specific drug classes that are difficult to detect vary by type of specimen. As a result, it will require additional study to assist agencies in determining how to select the appropriate type of specimen to be collected from a specific donor, when the use of a specific drug is suspected. Nevertheless, HHS believes that the addition of alternative specimens to the Federal Workplace Drug Testing Program would complement urine drug testing and aid in combating the risks posed from available methods of suborning urine drug testing through adulteration, substitution, and dilution. Thus, HHS will continue to pursue testing using alternative specimens. HHS anticipates issuing further revisions to the Mandatory Guidelines addressing the use of oral fluid, sweat patch, and hair, and the use of POCT devices for urine and oral fluid. These revisions will be published in the Federal Register , with opportunity for public comment. All written comments were reviewed and taken into consideration in the preparation of these revised Guidelines. The preamble only addresses sections of the draft Guidelines regarding urine testing that were commented on during the public comment period or that the Department is changing. Most section numbers for the Guidelines issued in April 2004 were changed in these Guidelines due to the removal of those sections concerning alternative specimens and POCT as well as for clarity. To make it easier for the public, the preamble refers to the new section number and, where appropriate, the corresponding section number in the Proposed Revisions to Mandatory Guidelines issued in April 2004. Similar comments are considered together in the discussion. Reason for the Effective Date An effective date of 18 months from the date of publication of these revised Mandatory Guidelines was chosen to permit the following activities: (1) It will take at least 12 months for manufacturers of immunoassay test kits to modify or manufacture immunoassay test kits and ensure compliance with any applicable statutory and regulatory requirements before commercialization of the modified kits. (2) It will take the HHS-certified laboratories at least one month to validate and implement the new test kits. (3) It will take 2 to 3 months for the National Laboratory Certification Program (NLCP) to challenge the HHS-certified laboratories with performance testing (PT) samples to ensure that the test kits and test results satisfy the required performance criteria. The effective time frame of 18 months will encompass many activities that will overlap or occur at the same time within different industries and Federal agencies. Summary of Public Comments and the HHS Response The following comments were directed to the information and questions in the preamble. Initial Test Kit Issues In the proposed Guidelines, the Department requested comments on issues regarding the testing for amphetamine analogs using one or two immunoassay test kits because the laboratory or IITF would be required to test specimens for the target analytes listed under amphetamines. Two commenters believed that two separate initial test kits would be needed to appropriately screen specimens for amphetamines as specified in Section 3.4. One commenter believed three separate initial test kits may be required. Six commenters believed that one initial test kit could be used to screen for amphetamine, methamphetamine, and their analogs. For the most part, the commenters provided justifications for their comments. The Department has evaluated the comments and has concluded that using either a single initial test kit or multiple initial test kits is acceptable depending on the specificity and sensitivity that the single initial test kit has with amphetamine and methamphetamine and its cross-reactivity with methylenedioxymethamphetamine (MDMA). Subpart A—Applicability The Department has revised Section 1.1 to state that the requirements in these Guidelines also apply to collectors and MROs. This revision ensures that collectors and MROs are notified of the applicable requirements under these Guidelines. In Section 1.5, where terms are defined, the Department has added several new definitions for terms that appear in the Guidelines, and revised several definitions that needed clarification even though no comments were received from the public. The Department has changed the term to be defined from “adulterated” to “adulterated specimen.” The meaning of the term has not changed. Only the wording has been changed to make the definition clearer. Definitions were added for “alternate responsible person” and “alternate responsible technician,” the individuals who are pre-approved by HHS to assume responsibility for the HHS-certified drug testing laboratory or IITF, respectively, when the responsible person or responsible technician is absent for an extended period. The definition for “cancelled test” was reworded for clarification. The definition is the same. The term “carryover” was defined. Carryover, as used in these Guidelines, refers to the condition that results when the test result for one sample has been affected by a preceding sample during analysis. For example, if the concentration of a drug in one sample is very high and cannot be completely eliminated from the analytical instrument before the next sample is tested, the residual drug in the analytical instrument contributes to the concentration of that drug in the next sample. The definition for “certifying scientist” was revised to indicate that a certifying scientist can report any test result reported from an HHS-certified laboratory. The proposed definition referred to “non-negative or invalid result.” Since the term “non-negative” was deleted from these Guidelines, the definition for certifying scientist needed to be revised. The definition for “certifying technician” was revised to state that a certifying technician can report on the chain of custody and scientific reliability of negative, negative/dilute, and rejected for testing results. This revised definition clarifies which types of results a certifying technician can report. The proposed definition incorrectly permitted the certifying technician to report on the chain of custody and scientific reliability of only negative test results. The term “confirmatory validity test” was changed to “confirmatory specimen validity test.” The term “validity test” was changed to “specimen validity test” throughout the Guidelines, to be consistent with current terminology used by the Department. The definition for a “cutoff” was revised to apply to specimen validity tests, as well as drug tests. The term is used in both contexts. The definition for “dilute specimen” was revised to state that the term applies to a urine specimen with creatinine and specific gravity values that are lower than expected but still physiologically possible. This change shows that a dilute specimen is different from a substituted specimen. The definition for “failed to reconfirm” was revised to clarify that the term applies when a second laboratory tests a split (Bottle B) specimen and is unable to corroborate the original test result reported by the primary laboratory. The definition for “follow-up test” was removed. The definition for “follow-up test” is provided in Federal agency drug testing plans and does not need to be repeated in the Guidelines. The definition for an “initial validity test” was changed to “initial specimen validity test” throughout the Guidelines to be consistent with current terminology used by the Department. The term was also revised to include an “invalid result” because an “invalid result” requires using an initial specimen validity test as would an adulterated, diluted, or substituted test result. To avoid confusion, the definitions for an “instrumented initial test facility” and for a “laboratory” were revised to show that these are permanent locations. The definition for “invalid result” was revised to clarify that this type of result is reported when the test results satisfy the criteria established in Section 3.8. The definition in the draft issuance did not include all of the criteria described in Section 3.8. A definition for “limit of detection” (LOD) has been added to these Guidelines because the Guidelines require the laboratory to determine the LOD for each confirmatory drug test during assay validation. In addition, to validate specimen validity tests, laboratories and IITFs are required to demonstrate and document appropriate assay characteristics, which may include the LOD. A definition for “limit of quantitation” (LOQ) has been added to these Guidelines because the Guidelines require the laboratory to determine the LOQ for each confirmatory drug test during assay validation. In addition, to validate tests used to determine specimen validity, laboratories and IITFs are required to demonstrate and document appropriate assay characteristics, which may include the LOQ. Lastly, laboratories and IITFs are required to use the established LOQ as the decision point for adulterants without a program-specified cutoff. A definition for a “lot” has been added to these Guidelines because throughout the Guidelines there are requirements to validate or verify the performance characteristics of various items (e.g., drug test kits, reagents, quality control material) and to establish an expiration date. The term “lot” refers to the item(s) manufactured from the same starting materials within a specified period of time which have essentially the same performance characteristics and the same expiration date. The definition for a “negative result” was revised to clarify that the specimen must not only be negative for drugs but must also be a valid urine specimen. Since these Guidelines require that specimen validity tests be conducted on each specimen, this definition states that a “negative result” indicates that a specimen is not only negative for drugs but also that the specimen validity tests conducted on the specimen indicate that the specimen is a valid specimen. The definition for a “non-negative” result was removed from the list of definitions and replaced with more specific reporting terms as follows: Positive result, substituted specimen, adulterated specimen, or invalid specimen result. The definition for a “performance testing (PT) sample” was revised to show that it refers to samples that are program-generated and sent to a testing facility. The proposed definition did not indicate the source of the samples. The definition for a “post-accident test” was removed. The definition for “post-accident test” is provided in Federal agency drug testing plans and does not need to be repeated in the Guidelines. The definition for a “pre-employment test” was removed. The definition for “pre-employment test” is provided in Federal agency drug testing plans and does not need to be repeated in the Guidelines. The definition for a “quality control (QC) sample” was revised to clarify that the term refers to calibrators or controls. The definition for a “random test” was removed. The definition for “random test” is provided in Federal agency drug testing plans and does not need to be repeated in the Guidelines. The definition for a “reasonable suspicion/cause test” was removed. The definition for “reasonable suspicion/cause test” is provided in Federal agency drug testing plans and does not need to be repeated in the Guidelines. The definition for “reconfirmed” was revised to clarify that the definition applies to a split specimen (Bottle B) tested by a second laboratory. The definition for “return to duty test” was removed. The definition for “return to duty test” is provided in Federal agency drug testing plans and does not need to be repeated in the Guidelines. The definition for “rejected for testing” was revised to clarify that this result may be reported by an IITF, as well as a laboratory. Three commenters noted the terms “sample” and “specimen” were used interchangeably throughout the Guidelines and suggested that the definitions be defined and the text updated accordingly. The Department agrees and has revised the definitions for these terms and has revised the Guidelines text to consistently use the terms as they are defined in this section. “Sample” refers to a performance testing (PT) sample, a quality control sample, or a representative portion of a donor specimen. “Specimen” refers to the donor specimen (i.e., urine provided by the donor for the drug test). The term “split specimen” was replaced by “split specimen collection.” The definition of a “split specimen collection” states that one urine specimen of sufficient volume is collected and then divided into two separate specimen bottles. A “split specimen collection” does not permit collecting two different urine specimens at two different times that are, respectively, transferred to a Bottle A and a Bottle B. The definition for “substituted” was changed to “substituted specimen” and revised to define this as a specimen submitted in place of the donor's urine, as evidenced by creatinine and specific gravity values outside physiologically producible ranges of human urine. Section 1.6 describes what an agency is required to do to protect employee records. The policy in this section is the same as the policy in the Proposed Revisions to Mandatory Guidelines. The Department has included a discussion on the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Department has included a new Section 1.7, to clarify refusals to test and who ultimately determines if the conditions for verifying them are met (i.e., the collector, the MRO, the Federal agency). Subpart B—Specimens Section 2.1 states that urine is the only specimen that can be collected by a Federal agency under the Guidelines for its workplace drug testing program to clarify that Federal agencies are prohibited from collecting any other type of specimen. Section 2.2 describes the circumstances under which a Federal agency may collect a specimen. The Department has included this section to ensure that the circumstances described are consistent with the reasons for collecting a specimen as listed on the Federal CCF. Section 2.3 requires each urine specimen to be collected as a split specimen. This policy is the same as the policy described in the Proposed Revisions to Mandatory Guidelines. Five commenters opposed the part that the single urine specimen collection procedure was being eliminated. The Department disagrees with the commenters and has eliminated the single urine specimen collection procedure, not because the procedure is forensically or scientifically unsupportable, but because the split specimen procedure ensures that the donor will have access to a split specimen that was not opened by the laboratory testing the primary specimen. Additionally, there are a number of Federal employees working for agencies that have employees subject to both Federal drug testing guidelines and Department of Transportation workplace drug testing regulations. Requiring the use of a split specimen collection procedure will ensure that employees working in these dual regulation situations are treated the same. Subpart C—Drug and Specimen Validity Tests Section 3.1 describes the tests that are performed on each urine specimen. The policy in this section applies to each specimen collected by a Federal agency regardless of the circumstance for which it was collected as described in Section 2.2. The Department believes that the wording of the policy in the current and Proposed Revisions to Mandatory Guidelines may be incorrectly interpreted such that the required tests only apply to specimens collected from Federal agency applicants and specimens collected at random. However, this is not the case. The wording in this section has been revised to state that each specimen collected will be tested for the same drugs and specimen validity tests. This section was also revised to describe the specimen validity tests that must be performed on each urine specimen. The requirements and explanations described for the specimen validity tests are the same as those described in the current and Proposed Revisions to Mandatory Guidelines. Section 3.2 provides guidance on how a Federal agency may test a specimen for additional drugs. Three commenters requested additional guidance on how a Federal agency would request permission to test for an additional drug on a case-by-case basis. The Department believes the policy in Section 3.2(a) adequately describes how a Federal agency would request to test a donor's specimen for a suspected Schedule I or Schedule II drug that is not part of the Federal program. After further review of Section 3.2(a), however, the Department recognized that the Guidelines do not address how to proceed if the Federal agency is requesting to test for a Schedule I or II drug for which an immunoassay test is not available. The Department thus has added that when the need to test for an additional drug occurs and there is no immunoassay test available, an HHS-certified laboratory should be permitted to test for the drug by testing two separate aliquots of the specimen using the same confirmatory drug test. The confirmatory drug test used by the laboratory must satisfy the requirements in Section 11.13, the laboratory must validate the confirmatory drug test in accordance with the requirements in Section 11.14, and must satisfy the quality control requirements as stated in Section 11.15. The Department believes that testing the specimen twice using a validated confirmatory drug test is scientifically and forensically acceptable. Additionally, when a specimen is reported as positive, adulterated, or substituted, the Department allows the donor to request that Bottle B be tested at another HHS-certified laboratory by the confirmatory method. The testing of the split specimen by a second HHS-certified laboratory to reconfirm the drug reported positive by the first laboratory is sufficient to protect the donor's interests. Section 3.3 states that urine specimens collected for Federal agency workplace drug testing programs may only be tested for the purpose of detecting drug use and to determine the validity of the specimen unless otherwise authorized by law. Several commenters expressed concern over the possibility that DNA testing could be conducted on a specimen. The Department states in Section 3.3(a) that “Federal agency specimens * * * must only be tested for drugs and to determine their validity unless otherwise authorized by law.” The Department is satisfied that the policy, as stated, prohibits DNA testing on a specimen but has removed the phrase “unless otherwise authorized by law” from this section to clarify that Federal agency specimens must only be tested for drugs and to determine their validity. Section 3.4 lists the drugs and drug metabolites and the initial and confirmatory cutoff concentrations used to test and report urine specimens as negative or positive for a drug. The initial and confirmatory cutoff concentrations are the same as in the Proposed Revisions to Mandatory Guidelines, but the tables have been combined to make it easier for the readers. Several commenters suggested including the scientific rationale used to support the proposed changes to the cocaine metabolite (benzoylecgonine) and amphetamine cutoff concentrations. Three commenters disagreed with the proposal to lower the amphetamines initial test cutoff concentration. Two of the three commenters were concerned that the lower cutoff will result in higher costs and more false initial test positives due to medications available over the counter. The third commenter stated that their laboratory currently has customers who use the lower amphetamine cutoff concentration and have no more confirmed positives than compared to a 1000 ng/mL initial test cutoff, but who do have more unconfirmed specimens. The Department believes the revised cutoff concentrations will increase the window of detection for these drugs, i.e., the number of hours after a drug is ingested by an individual that the concentration of the drug or drug metabolite in urine will likely remain above the cutoff concentration. Lower cutoff concentrations will increase the number of urine specimens that are identified as containing cocaine metabolites and amphetamines and, thereby, will increase the deterrent effect of the program and improve identification of employees using illicit substances. Based on results reported by laboratories in the current urine PT program, the Department believes that certified laboratories (and IITFs after they are certified) will have the ability to report accurate test results using these revised cutoff concentrations. There is no evidence available to the Department to indicate that lowering these cutoff concentrations will increase the possibility that a donor who has not actually used cocaine or amphetamines will be identified as a drug user. The Department also points out that the individual can always challenge the result with the MRO. Several commenters raised questions regarding the proposed options for HHS-certified laboratories and IITFs to perform an initial test for 6-AM. The commenters stated that the policy options were unclear as presented in Section 3.4, and recommended that HHS provide additional guidance to prevent inconsistent treatment of specimens. The Department has revised the table and footnotes in Section 3.4 to clarify that all specimens tested for opiates must be tested for 6-AM. This policy allows a laboratory to confirm and report 6-AM by itself, in contrast to the current Guidelines policy which requires 6-AM to be tested and reported in conjunction with a positive morphine result. Data from laboratories indicate that 6-AM is present in specimens even when the morphine concentration is below 2000 ng/mL. Sections 3.5, 3.6, 3.7, and 3.8 describe the criteria for reporting a urine specimen as adulterated, substituted, dilute, and invalid, respectively. Each section was revised to clarify that only a certified laboratory may report a specimen as adulterated, substituted, or invalid; that only a certified laboratory may report a specimen as dilute when creatinine is equal to or less than 5 mg/dL; and that a laboratory or an IITF may report a specimen as dilute when creatinine is greater than 5 mg/dL. For an adulterated or invalid urine specimen, one commenter requested the rationale for changing from the 20 mcg/mL chromium (VI) [Cr (VI)] initial validity test cutoff in a previous draft (several preliminary versions of the Guidelines were posted on the SAMHSA workplace Web site before the Proposed Revisions to Mandatory Guidelines were published in the Federal Register to 50 mcg/mL in these Guidelines. One commenter recommended using the 20 mcg/mL Cr (VI) cutoff instead of 50 mcg/mL and provided supporting data. Although the Department agrees with the data provided, the 50 mcg/mL cutoff is consistent with the capabilities of current assays' sensitivity and specificity. Additionally, most, but not all, oxidants are quantified at concentrations greater than 50 mcg/mL when they are used as urine adulterants. Unpublished evaluations of samples spiked with Cr (VI) have shown that for Cr (VI) to be effective as an adulterant, the urine concentration is usually much greater than 100 mcg/mL. For these reasons, the Department believes that the 50 mcg/mL Cr (VI) cutoff is sufficient to identify adulteration with Cr (VI) and is appropriate. One commenter recommended using the limit of quantitation (LOQ) instead of the limit of detection (LOD) as the decision point for adulterant tests without a program specified cutoff. The commenter stated that an LOQ ensures that the adulterant has been both appropriately identified and quantified. The Department agrees and has revised the testing requirements in Sections 3.5 and 3.8 to require that the adulterant's concentration be equal to or greater than the LOQ that was determined by the HHS-certified laboratory. The Department has revised Section 3.7 to clarify that a dilute result may only be reported in conjunction with either a positive test result or a negative test result. When a urine specimen is determined to be adulterated or when an invalid result is being reported, the Department does not consider finding a dilute result for such a specimen as being correct. It is assumed that an adulterated or invalid urine specimen has been tampered with and, if it also happens to satisfy the dilute criteria, the dilute result would actually be meaningless. Additionally, by definition, when a urine specimen is reported as substituted it cannot be a dilute specimen. Therefore, a dilute result cannot be reported in conjunction with a substituted result. Subpart D—Collectors Section 4.1 describes who may collect a specimen for a Federal agency. Three commenters recommended allowing direct supervisors to routinely collect specimens for federal agency applicant tests. The Department disagrees and has always prohibited an immediate supervisor or hiring official from routinely acting as a collector, unless no other collector is available and only when the supervisor or hiring official is a trained collector. Section 4.2 describes who may not collect a specimen. Seven commenters were opposed to the policy which prohibits testing facility employees from collecting specimens if they could link the donor's identity to the test results. The Department has always prohibited testing facility (HHS-certified laboratory) employees from collecting specimens if they could link the donor's identity to the test results and believes that this policy is appropriate. The Department revised this section to prohibit an employee who is in a testing designated position and subject to the Federal agency drug testing rules from serving as a collector for co-workers who are in the same testing pool or who work together with that employee on a daily basis, and to prohibit an individual from collecting his or her own urine for a federally regulated drug test. Section 4.3 describes the requirements for an individual to be a collector for a Federal agency. Seven commenters disagreed with requiring collectors to read and understand the Guidelines and felt this should be limited to the sections pertaining to the collection of specimens. The Department agrees and has revised the policy in Section 4.3(a) to reflect that a collector must be knowledgeable of the collection procedure described in the Guidelines. Four commenters suggested that there should be standardized collector training requirements and documentation requirements for all collectors. The Department has revised Section 4.3 to provide more details on the requirements for collector training and the documentation requirements. The Department believes the requirements as described in this section are sufficient and appropriate to ensure that the collector can properly collect a specimen and correctly complete the Federal Drug Testing Custody and Control Form (Federal CCF). Several commenters believe it is not sufficient to allow the agency to select the observer if there is no collector of the same gender available, as stated in the Proposed Revisions to Mandatory Guidelines. To address this concern, the Department has included a new Section 4.4 that specifies training requirements for an individual to serve as an observer for a direct observed collection (as described in Section 8.9). The training requirements are designed to ensure that any individual serving as an observer has been trained in procedures for a direct observed collection, although he or she may not be a trained collector. Other training elements are included to ensure that the observer interacts with the donor in a professional manner, respecting the donor's modesty and privacy, and that he or she maintains the confidentiality of collection information. The Department also revised this section to allow the collector or collection site supervisor to select the observer. Section 4.5 describes the requirements for an individual to be a trainer for collectors. Three commenters noted that the Guidelines did not address approval and monitoring of the “train the trainer” courses. Currently there are organizations (e.g., manufacturers, private entities, contractors, Federal agencies) that offer “train the trainer” courses. The Department does not believe that it is necessary or appropriate to approve the content of the “train the trainer” courses. If a trainer does not properly train individuals to be collectors, collector errors will result as the Guidelines are enforced and will demonstrate the need to retrain those trainers. Section 4.6 describes what a Federal agency must do before an individual is permitted to collect specimens. Five commenters disagreed with the requirement for an organization that manages/employs collectors to retain the collector training documents, saying this would be burdensome. The commenters recommend that collectors be responsible for their own documentation. The Department agrees that many collectors currently retain their training records and has revised the policy to indicate that a collector (who may be self-employed) or organization (e.g., collector training company, third party administrator, Federal agency that employs its own collectors) must maintain a copy of the record that documents his or her training. The Department has also revised the question to require the Federal agency to ensure that the requirements of this section are satisfied before a collector is permitted to collect specimens rather than placing the burden on an organization to satisfy the requirements. The Federal agency is always responsible for ensuring that a collector is properly trained. Subpart E—Collection Sites Section 5.1 describes a collection site as a permanent or temporary facility. The requirement for a collection site to have provisions for donor privacy during the collection procedure has been moved from Section 5.1 to Section 5.2, which describes the specific requirements for a facility that is being used as a collection site. Two commenters recommended including additional criteria in Section 5.2 for a collection site to have a secure working area and donor privacy. The Department agrees and is requiring the collection site in Section 5.2(a) to have provisions to ensure donor privacy. Privacy requirements are set forth in Section 8.1. In addition, Section 5.2(b) has been revised to reflect the need for a suitable clean working area that is not accessible to the donor. The Department believes the clean working area must not be accessible to the donor because, if given an opportunity, a donor may attempt to tamper with records, documents, or supplies. The Department also added Section 5.2(g) to require facilities to have the ability to limit donor access to potential contaminants, adulterants, or diluents. Section 5.3 describes how long records must be stored by collection sites. The record storage requirements in this section are the same as those described in the Proposed Revisions to Mandatory Guidelines. The Department revised the section to specify the records that must be retained. Subpart F—Federal Drug Testing Custody and Control Forms Section 6.1 states that an OMB-approved Federal CCF must be used to document the collection of a urine specimen. The requirement in this section is the same as the requirement described in the Proposed Revisions to Mandatory Guidelines. Section 6.2 describes what happens if the correct Federal CCF is not available or is not used. The Department recognizes that occasionally a current Federal CCF will not be available or a non-Federal form or expired Federal CCF will be used by mistake. The Department does not want this discrepancy to cause a laboratory or IITF to automatically reject the specimen for testing, or cause an MRO to automatically cancel the test. If the collector discovers the error before the specimen is packaged for shipment to a laboratory or IITF, the collector must note on the form that the specimen is a Federal agency specimen and give the reason for using the incorrect form. When this information is provided on the form, the laboratory or IITF simply proceeds with testing the specimen as a Federal agency specimen. If the laboratory, IITF, or MRO discovers that an incorrect form was used and there is no explanation given, the laboratory, IITF, or MRO must attempt to obtain a Memorandum For Record (MFR) from the collector explaining why an incorrect form was used. If a MFR cannot be obtained from the collector, the laboratory or IITF must report a rejected for testing result (i.e., when they discovered the error) and the MRO reports a cancelled test result. Subpart G—Specimen Collection Containers Section 7.1 describes the items to be used to collect a urine specimen. The Department added volume requirements for specimen containers to this section to ensure that the containers used would be of a sufficient size to hold the required amount of urine for primary and split specimens. Section 7.2 describes the requirement that the collection items used must not affect the specimen collected. The requirement in this section is the same as the requirement described in the Proposed Revisions to Mandatory Guidelines. However, the proposed statements regarding FDA clearance for these collection items has been removed. FDA has regulatory oversight of a collection item as a “device” within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FFDCA) (21 U.S.C. 321(h)), and a manufacturer must comply with all statutory and regulatory requirements for these devices. Subpart H—Specimen Collection Procedure Section 8 establishes the procedures for collection of a urine specimen. The Department revised and reorganized the urine collection procedures in the Proposed Revisions to Mandatory Guidelines for clarity and to address issues raised as described below. Section 8.1 states the privacy requirements for specimen collections. The procedure used to collect a urine specimen must ensure that a donor is given a sufficient amount of privacy under normal circumstances. That is, a donor is allowed to provide a urine specimen in the privacy of a restroom or an enclosed stall. Four commenters raised concerns with the privacy requirements that should be given a donor. The Department evaluated these comments and believes that it is more appropriate to address the privacy requirements in subpart H (which addresses the collection procedure) rather than discussing the privacy requirements in subpart E (which specifies the requirements for a collection site). Section 8.1(a) addresses the comments submitted by stating who may be present during a collection procedure. Section 8.1(b) states that the collector may be a different gender than the donor, but the observer of a direct observed collection procedure must be the same gender, and a monitor for a monitored collection must be the same gender unless the monitor is a medical professional. Section 8.1(c) clarifies that the privacy given to a donor is visual privacy because there may be situations where it is not possible to prevent the collector from hearing sounds in the enclosure where the donor is providing the specimen. Section 8.2 describes what a collector must do before starting a specimen collection procedure. One commenter noted that the proposed requirement to have “no other source of water (e.g., no shower or sink) in the enclosure where urination occurs” may not address temporary collection sites. The commenter recommended that the procedure be revised to state that the collector must disable or secure other sources of water in the restroom before starting the collection procedure. One commenter noted that many public restrooms are equipped with toilets that have sensors for automatic flushing. The Department agrees and has revised this section to read “There must be no other source of water (e.g., no shower or sink) in the enclosure where urination occurs that is not secured during the collection.” If the enclosure used by the donor to provide a specimen has a sink or other source of water besides the toilet that cannot be disabled or secured, the collector must perform a monitored collection in accordance with Section 8.11. The monitor will listen for any sounds that may suggest possible attempts by the donor to tamper with the specimen. Section 8.3 describes the preliminary steps in the collection process. Four commenters recommended that the Guidelines describe the type of identification the collector provides to the donor. The Department has revised Section 8.3(c) and included some examples of the type of identification that may be provided (e.g., driver's license, employee badge issued by the employer, any other picture identification issued by a Federal, State, or local government agency). Two commenters suggested that the collector must point out to the donor, but not require the donor to read, the collection procedure instructions on the back of the Federal CCF. The Department agrees with the comment and has revised Section 8.3(f) to direct the collector only to inform the donor where the donor can find the instructions for the collection on the back of the Federal CCF. The collector will allow the donor to read the procedure if the donor prefers. One commenter suggested that the donor be given the collector's full name, name of the collector's supervisor, name of the company conducting the test, and the MRO's name, telephone, and address. The Department agrees with this comment. With the exception of the name of the collector's supervisor, the rest of the commenter's request for information is recorded on the donor's copy of the Federal CCF. If some of the information is missing on the Federal CCF, it is the responsibility of the collector to obtain the information and to complete the Federal CCF in accordance with the instructions for the use of the Federal CCF for Federal agency workplace drug testing programs. Section 8.4 describes the steps that the collector takes in the collection process before the donor provides a urine specimen. The steps are the same as in the Proposed Revisions to Mandatory Guidelines, but include additional detail. Section 8.5 specifically addresses the situation where a donor states that he or she is unable to provide a urine specimen. Over 50 commenters expressed concern with the Department's urine collection policy. They stated that some individuals have what the commenters refer to as a “shy bladder.” The commenters noted that these individuals may be physically unable to provide a urine specimen upon demand, and forcing them to drink fluids creates a great deal of stress and may not change their ability to provide a specimen. The commenters were concerned with how a collector interacts with a donor who is unable to provide a sufficient amount of urine to perform a drug test. The Department's urine collection policy was designed to prevent an individual from intentionally circumventing the requirement to provide a urine specimen during a required collection. The policy is not intended to cause harm to anyone who has a condition that prevents them from providing a urine specimen when requested. The Department has always expected a collector to treat the donor with respect when the donor is unable to provide a specimen within a reasonable period of time (3 hours is considered reasonable). To address the concern, however, the Department has revised the urine specimen collection procedure. If the donor states that he or she cannot provide a specimen, the collector requests the donor to go into the restroom (stall) and attempt to provide a specimen. This attempt demonstrates the donor's inability to provide a specimen when the donor comes out of the stall with an empty collection container. At that time, if the donor states that he or she could provide a specimen after drinking some fluids, the collector allows the donor to drink some liquid (as stated in Section 8.5(b)(1)) and continues with the collection procedure. If the donor states that he or she simply needs more time, without a need to drink fluids, before attempting to provide a urine specimen, the collector gives the donor up to 3 hours to provide a urine specimen. If the donor states that he or she is unable to provide a urine specimen even after 3 hours, the collector records the reason for not collecting a urine specimen on the Federal CCF, notifies the Federal agency's designated representative, and sends the Federal CCF to the MRO and the Federal agency for further evaluation of the donor. The requirement for the further evaluation of the donor by an MRO will prevent individuals from being falsely accused of a refusal to test. Sections 8.5(b)(1) and 8.6(e)(2) describe the amount of fluid that a donor may be given at the collection site in order to collect a sufficient amount of urine. The reason why a limit is imposed at all is the concern for the welfare of the donor, as well as the concern that the urine specimen may become diluted. Several commenters expressed concern with the amount of fluids given to a donor at the collection site. The Proposed Revisions to Mandatory Guidelines instruction to the collector to give the donor a reasonable amount of liquid to drink is flexible in the amount given (note that the parenthetical in the Guidelines is stated as an example, not as a requirement). However, in response to the comment, the Department has changed the example in the Proposed Revisions to Mandatory Guidelines (“an 8 ounce glass of water every 30 minutes, but not to exceed a maximum of 24 ounces”) to read “an 8 ounce glass of water every 30 minutes, but not to exceed a maximum of 40 ounces over a period of 3 hours or until the donor has provided a sufficient urine specimen.” This change retains the flexibility that has always existed in the Federal program and sets a reasonable time limit within which most donors would be able to provide an acceptable amount of urine. Although the Department has changed the guidance on the amount of fluid given the donor, the Department does not require anyone to drink more fluid than he or she could comfortably drink. A statement has also been added to these sections to clearly state that the donor is not required to drink any fluids during this waiting time. The Department believes that most individuals who are unable to provide a sufficient specimen simply need some additional time to provide the required specimen without having a need to drink fluids. Section 8.6 describes the steps that the collector takes in the collection process after the donor provides a urine specimen. One commenter recommended that the collector be instructed to inspect the stall for signs of tampering before the donor is permitted to flush the toilet. While this practice is acceptable, the Department has not included this detail in the Guidelines. Sections 8.2 and 8.3 include pre-collection procedures to prevent or detect specimen tampering. Furthermore, Section 8.4(b) instructs the collector to perform a recollection under direct observation if the donor's conduct indicates a possible attempt to adulterate or substitute the specimen. Section 8.6 also includes procedures for the collector to measure the specimen temperature, visually inspect the specimen, and determine the specimen volume. Three commenters recommended deleting the proposed requirements for a collector to send a Bottle A specimen to the testing facility when there is an insufficient volume of urine collected for the split (Bottle B) specimen as required because this contradicted the proposed policy that a failure to provide 30 mL of urine for the second specimen collection prompts the collector to obtain guidance on the action to be taken. The Department agrees and has revised the collection procedures to stop the collection when the donor does not provide at least 45 mL, the amount required for a split specimen collection, after two attempts. When this occurs, the collector notifies the Federal agency's designated representative immediately, and notes on the Federal CCF the donor's failure to provide sufficient urine. The Federal CCF is sent to the Federal agency and the MRO. Subsequent actions by the MRO are described in Sections 13.5 and 13.6. Section 8.8 is a new section that combines the reasons that appear in different sections of the current Guidelines regarding when a direct observed collection is used. The reasons are the same; they have simply been combined in one section. Section 8.8(c) requires the collector to notify a collection site supervisor to review and concur with the collector's decision to perform a direct observed collection procedure. Three commenters disagreed with this policy. One commenter recommended requiring an agency representative in addition to the supervisor to review and concur with the decision. The Department believes obtaining permission from a supervisor is necessary when a decision is needed to conduct a direct observed collection. The concurrence from a supervisor will ensure that the collector is justified in using a direct observed collection procedure. The Department also included in this section the actions a collector must take when the donor refuses to provide a specimen under direct observation. Section 8.9 is a new section that describes how a direct observed collection procedure is conducted. The Proposed Revisions to Mandatory Guidelines discussed when a direct observed collection procedure is permitted, but did not provide guidance on how it is to be conducted. The Department has included additional information regarding direct observed collections. This information has been available from the Department and has been used since the beginning of the Federal drug testing program. The Department believes that the procedure will ensure that all direct observed collection procedures are conducted the same way regardless of the reason for using the direct observed procedure. In response to submitted comments, in addition to requiring the observer to be the same gender as the donor, the Department has specified in Section 8.9 that individuals must be trained in direct observed collection procedures in order to serve as an observer. Training requirements are included in a new Section 4.4. The Department included two new sections, Sections 8.9 and 8.10, to address when and how monitored collections are performed. Section 8.12 establishes how the collector reports a donor's refusal to test. The Proposed Revisions to Mandatory Guidelines discussed what constituted a refusal to test during the collection process, but did not provide guidance to the collector on how to report a refusal to test. Additional information regarding urine collection is available from the Department. In addition, the Department included an instruction for the collector to discard any urine collected when a refusal to test occurred during the collection process. Section 8.13 establishes the responsibilities for Federal agencies regarding collection sites. Many commenters disagreed with requiring Federal agencies to inspect all of their collection sites. The commenters believe this requirement to inspect the hundreds of collection sites would be cost-prohibitive and logistically impossible, and there does not seem to be evidence that errors by collectors are common enough to justify such an inspection program. Other commenters suggested that, in lieu of annual inspections of all collection sites, HHS require agencies to inspect only collection sites which have generated “fatal flaws.” The Department agrees that requiring Federal agencies to investigate and possibly inspect collection sites with “rejected for testing” errors ensures that collectors will receive appropriate training to prevent the recurrence of such errors. However, the Department maintains that random inspections are important to identify any collection procedure problems that may exist, but are not readily evident from the Federal CCF because the forms appear to be properly completed by the collector. The Department has revised the inspection requirements in this section accordingly. Federal agencies must inspect only 5 percent of the current number of collection sites, or up to a maximum of 50, selected randomly, of their collection sites each year. Additionally, Federal agencies are required to investigate reported collection site deficiencies (e.g., “rejected for testing” by either an HHS-certified laboratory or HHS-certified IITF) and take appropriate action which may include inspecting the collection site. The number of collection sites inspected because they have had “rejected for testing” results are not included in the 5 percent or maximum of 50 requirement. Subpart I—HHS Certification of Laboratories and IITFs The proposed section describing the goals and objectives of certifying laboratories and IITFs was removed from the Guidelines. Four commenters suggested that the discussion should be in the preamble rather than in the Guidelines. The Department agrees that the discussion in this section does not establish any specific analytical requirements and was removed from these Guidelines. Section 9.1 (Section 9.2 in the Proposed Revisions to Mandatory Guidelines) states that the Secretary has the authority to certify laboratories. Four commenters disagreed with the right of the Secretary to review private sector specimen results tested under the Guidelines. The Department understands the concerns expressed by the commenters; however, the review of private sector specimen or non-regulated specimen results, only occurs for those private sector specimens that are tested in batches that contain federally-regulated specimens. This usually occurs with confirmatory test batches because laboratories assemble these batches by taking the initial test positive specimens from different initial test batches to make the confirmatory test cost effective and efficient. Therefore, the policy described in this section is the same policy as described in the Proposed Revisions to Mandatory Guidelines. Section 9.2 (Section 9.3 of the Proposed Revisions to Mandatory Guidelines) describes the application process for a laboratory or IITF, procedures for maintaining certification, and what a laboratory or IITF must do when its certification is not maintained. In the Proposed Revisions to Mandatory Guidelines, the term “imminent harm” is used as a reason to require a laboratory to immediately stop testing Federal agency specimens. Three commenters objected to using the term “imminent harm” because they believe the term limits the Department's ability to suspend a laboratory or IITF. Although the Department has successfully suspended a number of laboratories using “imminent harm” as the basis for an immediate suspension, the term has been removed from these Guidelines. The reasons for taking action against a laboratory or IITF are more appropriately discussed in Sections 9.12, 9.13, and 9.14. The Department has revised Section 9.2(c) to clarify the requirements when a laboratory or IITF does not maintain its HHS certification. Section 9.3 (Section 9.5 of the Proposed Revisions to Mandatory Guidelines) describes the composition requirements for the PT samples that are used to challenge a laboratory or IITF's drug and specimen validity tests. The requirements in this section are the same as those contained in the current Guidelines, except for the pH specifications in Section 9.3(b)(2). These specifications were revised to challenge the pH tests used by IITFs, as described in Section 12.14(c)(1), as well as laboratory pH screening tests with a narrow dynamic range, as described in Section 11.18(c)(1). Section 9.4 (Section 9.9 of the Proposed Revisions to Mandatory Guidelines) describes the requirements that an applicant laboratory must satisfy when testing the 3 consecutive sets of PT samples sent to the laboratory during the initial certification process. Section 9.5 (Section 9.13 of the Proposed Revisions to Mandatory Guidelines) describes the requirements that a certified laboratory must satisfy when testing the quarterly sets of PT samples sent to the laboratory as part of the maintenance PT program. In both sections, the requirements are the same as in the current Guidelines with two exceptions concerning the evaluation of specific gravity results. The Department has retained the acceptable range of no more than ±0.0003 specific gravity units from the mean for PT samples with a mean less than 1.0100, but has increased the acceptable range to ±0.0004 specific gravity units when a PT sample's mean is equal to or greater than 1.0100. The Department has retained the limit of ±0.0006 specific gravity units from the mean for assessing errors for PT samples with a mean less than 1.0100, but has increased the limit to ±0.0007 specific gravity units when the PT sample's mean is equal to or greater than 1.0100. The Department has been evaluating the performance of the instruments used to measure specific gravity to 4 decimal places and believes increasing the precision limits for high specific gravity readings is reasonable and appropriate due to the nature of the refractive index and calibration methods using oil to calibrate the instruments. Section 9.6 (Section 9.17 of the Proposed Revisions to Mandatory Guidelines) describes the PT requirements an applicant IITF must satisfy to conduct urine testing and Section 9.7 (Section 9.21 of the Proposed Revisions to Mandatory Guidelines) describes the PT requirements that an HHS-certified IITF must satisfy to conduct urine testing. Both sections were revised to be consistent with PT challenges for the initial testing part of a laboratory (i.e., requirements addressing confirmatory test challenges were deleted). One commenter noted the requirement to correctly identify and report the total drug challenges over 3 sets of PT samples was 80 percent for applicant and certified IITFs, while it is 90 percent for applicant and certified laboratories. The commenter recommended that the requirement be the same for IITFs and laboratories. The Department agrees and has revised the requirement in Section 9.6(a)(1) to be 90 percent for applicant IITFs for initial testing. Section 9.8 (Section 9.22 of the Proposed Revisions to Mandatory Guidelines) describes the inspection requirements for an applicant laboratory or IITF and Section 9.9 (Section 9.23 of the Proposed Revisions to Mandatory Guidelines) describes the inspection requirements for an HHS-certified laboratory or IITF. The Proposed Revisions to Mandatory Guidelines required using at least two inspectors to inspect an applicant laboratory or IITF. Three commenters expressed concern with requiring at least two inspectors to inspect an applicant laboratory or IITF, while the Proposed Revisions to Mandatory Guidelines permit only one inspector to potentially be used to inspect an HHS-certified laboratory or IITF. The Department has revised Section 9.8 to require two inspectors rather than the proposed “at least two inspectors.” The Department believes that the inspection of an applicant laboratory or IITF must be conducted using two inspectors because this minimizes the possibility of a laboratory or IITF disputing the findings of one inspector as opposed to the findings from two inspectors. With regard to HHS-certified laboratories and IITFs, the Department retained the Proposed Revisions to Mandatory Guidelines requirement which states that an HHS-certified laboratory or IITF “is inspected by one or more inspectors.” The Department believes that one inspector is appropriate to inspect an HHS-certified laboratory or IITF when the facility is very small, has an extremely small workload, and has a history of acceptable performance on testing the PT samples and on previous inspections. The Department believes that using one inspector is sufficient to conduct a thorough inspection and makes it cost-effective for very small HHS-certified laboratories and IITFs to remain in the certification program. Section 9.10 specifies the criteria an individual must satisfy to be eligible for selection as an inspector for the Secretary under these Guidelines. This section also states that the Secretary of a Federal Agency may inspect an HHS-certified laboratory or IITF at any time. The requirements in this section are the same as in Section 9.24 of the Proposed Revisions to Mandatory Guidelines, but the section has been reworded for clarity. Section 9.11 describes what happens when an applicant laboratory or IITF fails to satisfy the minimum requirements for either the PT program or the inspection program. The Department believes that an applicant laboratory or IITF must successfully satisfy all of the initial certification process requirements or be required to begin the process from the very beginning. That is, submit a new application with corrective actions indicated and then successfully satisfy the requirements for the 3 sets of PT samples. These requirements are the same as in the Proposed Revisions to Mandatory Guidelines, Section 9.25. Section 9.12 describes what happens when a certified laboratory or IITF does not satisfy the minimum requirements for either the PT program or the inspection program. The policy in this section is the same as that contained in the current and Proposed Revisions to Mandatory Guidelines in Section 9.26. Section 9.13 describes the factors that are considered when determining whether to revoke a laboratory's or IITF's certification. The factors described are the same as those contained in the current and Proposed Revisions to Mandatory Guidelines in Section 9.27. Section 9.14 states that the Secretary may suspend a laboratory's or IITF's certification to protect the interests of the United States. This policy is the same as that contained in the current and Proposed Revisions to Mandatory Guidelines in Section 9.28. Section 9.15 describes how the Secretary notifies a laboratory or IITF that action is being taken against the laboratory or IITF. The policy in this section is the same as the policy described in the current and Proposed Revisions to Mandatory Guidelines in Section 9.29. Section 9.16 describes how a laboratory that has had its certification revoked can apply for recertification. The policy is the same policy as described in the current and Proposed Revisions to Mandatory Guidelines in Section 9.30. Section 9.17 states that the list of HHS-certified laboratories and IITFs will be published monthly in the Federal Register . This policy is the same policy as described in the current and Proposed Revisions to Mandatory Guidelines in Section 9.31. Subpart J—Blind Samples Submitted by an Agency Section 10.1 describes the requirements for Federal agencies to submit blind samples to certified laboratories or IITFs. Four commenters expressed concern that the proposed requirement to submit only 1 percent blind samples was too low. The Department agrees and has revised Section 10.1(b) to require each agency to submit 3 percent blind samples each year rather than having one requirement for the first 90 days (3 percent) and a different requirement after 90 days (1 percent). The Department also notes that the HHS-certified laboratories and IITFs will also be evaluated using quarterly PT samples and will be receiving the 3 percent blind samples from several agencies to ensure that they are properly handling and testing donor specimens. The policy in Section 10.1(c) describing the percentage of negative, positive, and adulterated or substituted blind samples to be submitted was revised. The proposed 80 percent negative blind samples was changed to 75 percent negative blind samples, and 20 percent non-negative was changed to 15 percent positive and 10 percent adulterated or substituted. Section 10.2 describes the specific requirements for each blind sample and the requirements are the same as those contained in the current and Proposed Revisions to Mandatory Guidelines. Section 10.3 describes how a collector submits a blind sample to be tested. The requirements in this section are the same as those in the Proposed Revisions to Mandatory Guidelines. Section 10.4 describes what happens when an inconsistent result is reported on a blind sample. The requirements in this section are the same as those in the Proposed Revisions to Mandatory Guidelines. Subpart K—Laboratory Section 11.1 requires each certified laboratory to have a standard operating procedure manual and describes what information must be contained in the manual. The requirements in this section are the same as those in the current and Proposed Revisions to Mandatory Guidelines. Section 11.2 describes the responsibilities of the individual who has responsibility for the day-to-day management of the urine drug testing laboratory. This individual is called the responsible person (RP). The responsibilities described in this section are the same as those described in the current and Proposed Revisions to Mandatory Guidelines, except the requirement that the RP qualify as a certifying scientist was moved to Section 11.3(e). The Department believes the requirement that the RP qualify as a certifying scientist is more appropriately included as a qualification rather than a responsibility. Section 11.3 describes the scientific qualifications that an individual must have to serve as an RP. Three commenters believe the requirement for an RP to have experience with the collection and analysis of biological specimens is too general. The Department believes the qualification as stated in Section 11.3(b) is appropriate and does not need to specifically focus on collecting urine specimens. The primary purpose for this qualification is that the RP has experience and knowledge of the general procedures and issues that may arise with the collection and analysis of biological specimens (e.g., chain of custody, storage, handling, troubleshooting problems). The qualifications described in this section are the same as those described in the current and Proposed Revisions to Mandatory Guidelines. Section 11.4 describes what happens when an RP is absent or leaves a certified laboratory. This section has been revised to require a laboratory to have multiple RPs or one RP and an alternate RP. The requirement in the Proposed Revisions to Mandatory Guidelines did not make it clear that the laboratory must have an alternate RP when there is only one RP. The Department believes this requirement and establishing time limits for the alternate RP to assume RP duties when an RP is absent from a laboratory will minimize the impact on the laboratory, and enable the laboratory's continued compliance with the Guidelines when the RP is absent. The Department has revised Section 11.4(c) to state that an alternate RP must be found acceptable during an on-site inspection of the laboratory. This requirement ensures that the alternate RP is pre-approved. The Department believes an individual must be pre-approved as an alternate RP to ensure that someone with the appropriate knowledge and qualifications can assume RP responsibilities when the RP is absent from the laboratory. Section 11.5 describes the qualifications an individual must have to certify a result reported by an HHS-certified laboratory. An individual who certifies results may be either a certifying scientist (CS) or a certifying technician (CT) depending on the type of test result he or she is certifying. The Department has decided to retain the bachelor's degree or equivalent requirement for the certifying scientist qualifications as described in the current Guidelines. The Department believes the training and experience specified in the Proposed Revisions to Mandatory Guidelines for a CT are sufficient to ensure that the CT can properly certify a negative, negative/dilute, or rejected for testing result. One commenter stated that the qualifications for a CT in an HHS-certified laboratory were not consistent with the qualifications for a CT in an HHS-certified IITF as described in the Proposed Revisions to Mandatory Guidelines. The same requirements are specified for a CT in the laboratory and IITF sections (i.e., Sections 11.5(b) and 12.5, respectively). The Department has further clarified that qualifications for a CT are the same in a laboratory and in an IITF by revising the definition for a certifying technician in Section 1.5. The revised definition states that a CT can verify negative, negative/dilute, and rejected for testing results reported by a laboratory or IITF. Section 11.6 describes the qualifications and training other laboratory personnel must have. The policy in this section is the same as the policy described in the current and Proposed Revisions to Mandatory Guidelines, except that the current and Proposed Revisions to Mandatory Guidelines do not specifically state that the training must be documented. Section 11.7 describes the security measures that a certified laboratory must maintain. This section has been revised to require the authorized escort to enter his or her name in the record used to document the entry of authorized visitors. The current and Proposed Revisions to Mandatory Guidelines did not require such documentation. Section 11.8 describes internal laboratory chain of custody requirements. The policy in this section is the same as the policy in the Proposed Revisions to Mandatory Guidelines. Section 11.9 describes the tests an HHS-certified laboratory must conduct on a specimen received from an IITF. Three commenters expressed concern with requiring an HHS-certified laboratory to conduct only the confirmatory test(s) on specimens received from an HHS-certified IITF. The commenters recommended that an HHS-certified laboratory test all specimens received from an HHS-certified IITF as if the specimens had not been previously tested. The commenters believe it is important that all analytical results supporting a positive, adulterated, substituted, or invalid result should be generated within the same facility. The Department agrees and has revised this section to require an HHS-certified laboratory to test each specimen received from an HHS-certified IITF in the same manner as if it had not been previously tested. This revision ensures that the final analytical results (both the initial and confirmatory data) and internal chain of custody documents are generated by one HHS-certified laboratory and can be properly reviewed and certified before the test result is released. Section 11.10 describes the requirements for an initial drug test. One commenter stated that paragraph (c) of the Proposed Revisions to Mandatory Guidelines did not clearly state that the initial drug test kits must be “FDA-cleared.” The Department agrees and clarified that drug tests must be approved, cleared, or otherwise recognized by FDA as accurate and reliable for the testing of a specimen for identifying drugs of abuse or their metabolites. Therefore, it is more appropriate to refer to “FDA requirements” rather than limit the language to “FDA-cleared.” We note that only those test kits subject to FDA premarket notification requirements must be “FDA-cleared.” One commenter believes that the purpose for conducting a second initial test was not clearly stated in paragraph (d). The Department agrees and has revised this paragraph to indicate that a second initial drug test may be used when the second initial drug test has a different specificity than the first initial drug test. The second initial test must satisfy the batch quality control requirements for an initial drug test. Section 11.11 describes what a laboratory must do to validate an initial drug test before using it to test donor specimens. One commenter recommended that the requirements to validate an initial drug test should be more stringent. The Department believes these requirements are appropriate and that they give an HHS-certified laboratory the flexibility it needs to validate the initial drug tests based on the instruments they are using. The Department also moved the requirement from Section 11.13 to document the effect of carryover to this section, because it is more appropriate to evaluate the possibility of carryover when the initial drug test is validated. Knowing when and if carryover can affect donor specimen results allows a laboratory to determine when corrective action must be taken to control for carryover. Section 11.12 describes the batch quality control requirements when conducting initial drug tests. The requirements in this section are the same as those described in the current and Proposed Revisions to Mandatory Guidelines. Section 11.13 describes the requirements for a confirmatory drug test. Four commenters disagreed with allowing the use of other chromatographic separation and mass spectrometry techniques for the confirmatory drug tests. They believe that gas chromatography/mass spectrometry (GC/MS) has been the gold standard since the Federal Workplace Drug Testing Program began and should be the only accepted confirmatory method until other methods are proven to be reliable and scientifically supportable. The Department disagrees and believes that other methods, such as liquid chromatography/mass spectrometry (LC/MS), LC/MS/MS, and GC/MS/MS, have been proven to be reliable to test specimens. While GC/MS remains the most common confirmatory testing technology used in forensic drug testing laboratories, the Department does not want to prohibit laboratories from using technologies that provide forensically and scientifically supportable results. The Department proposed that these additional technologies be allowed in Federal workplace drug testing programs only after a thorough review of extensive information obtained through technical working groups consisting of drug testing and analytical chemistry experts. No comments were submitted that justified removal of these technologies from the proposed Guidelines. Since the proposed revisions to the Guidelines were published in April 2004, the use of these technologies has become even more widespread and there have been numerous studies employing these methods, providing additional data to demonstrate their forensic and scientific acceptability. These methods may offer some benefits over traditional GC/MS methods. For example, GC and LC provide a means to separate drugs of abuse from other compounds found in urine. The advantage of LC methods is that they may require less specimen preparation prior to analysis, thereby saving time and costs. Likewise MS and MS/MS methods are highly selective, reducing the chance that other substances present in the urine might interfere with the analysis and prevent the laboratory from obtaining a valid result. MS/MS technology provides an advantage in that it is also more sensitive than GC/MS. A properly validated and controlled GC/MS method is sensitive enough to meet the requirements of these Guidelines for forensic urine drug testing. However, the increased sensitivity provided by MS/MS can enable laboratories to use less specimen volume, which may have implications in some cases (e.g., when there are multiple drugs present in a specimen). Furthermore, many laboratories have implemented instruments and test methods using these different chromatographic and/or mass spectrometric technologies for forensic applications other than federally regulated workplace testing. Therefore, laboratories that are currently certified or plan to seek certification under these Guidelines may already have the experience and capability to employ these methods in Federal workplace testing programs or they may want to add these newer technologies to their testing protocols. Section 11.14 describes what a laboratory must do to validate a confirmatory drug test before using it to test donor specimens. The Department moved the requirement from Section 11.16 to document the effect of any carryover to this section, because it is more appropriate to evaluate the possibility of carryover when the confirmatory drug test method is validated. Knowing when and if carryover can affect donor specimen results allows a laboratory to determine when corrective action must be taken to control for carryover. Section 11.15 describes the batch quality control requirements when conducting confirmatory drug tests. Three commenters recommended that this section be revised to allow using a multi-point calibration as well as a single-point calibration for each batch of specimens when conducting a confirmatory test. The Department agrees and has revised Section 11.15(a)(1) to read “A calibrator with its drug concentration at the cutoff.” This revision allows multi-point calibration, while still requiring a cutoff calibrator. Section 11.16 describes the analytical and quality control requirements for conducting specimen validity tests. The requirements are the same as those described in the current Guidelines, except that Section 11.16(b) specifically refers to the requirements specified in Section 11.18 rather than simply stating that appropriate calibrators and controls must be included. The Department believes this revision will ensure that each laboratory will use the same calibrators and controls when conducting specimen validity tests. Section 11.17 is a new section that describes what a certified laboratory must do to validate a specimen validity test. The Department is establishing these requirements to ensure that specimen validity tests, like drug tests, are validated before they are used for donor specimens. The policy has been intentionally written as a general requirement because each type of specimen validity test has different performance characteristics. Section 11.18 describes the requirements for conducting each type of specimen validity test on a urine specimen. One commenter recommended allowing an HHS-certified laboratory to use a three decimal place refractometer as a preliminary specific gravity test to determine if the initial specific gravity test must be conducted. The Department agrees and has revised Section 11.18(b)(1) to allow a laboratory to use a refractometer measuring to at least three decimal places as a specific gravity screening test when the creatinine is greater than 5.0 mg/dL and less than 20 mg/dL. However, laboratories must use a four decimal place refractometer to measure specific gravity for specimens when the initial creatinine test result is equal to or less than 5.0 mg/dL or when the screening specific gravity test result using a three decimal place refractometer is less than 1.002. These criteria were selected for deciding whether a three or four decimal refractometer must be used because the test results are approaching the criteria for reporting a substituted specimen which may lead to adverse personnel action. The Department also added the quality control requirements for conducting the specific gravity screening test. One commenter recommended that colorimetric specific gravity assays be permitted for use as the initial specific gravity test. The Department disagrees because these assays lack the required accuracy and precision to serve as an initial specific gravity test. One commenter recommended that pH meters used for the initial and confirmatory pH tests should print a paper copy report or be interfaced with a Laboratory Information Management System (LIMS) or computer. The commenter noted that the Guidelines include this requirement for refractometers used to conduct the initial and confirmatory specific gravity tests, and the same forensic considerations apply for pH tests. The Department agrees and has added Section 11.18(c)(2) specifying that a pH meter used for the initial and confirmatory pH tests must report and display pH to at least one decimal place, and must be interfaced with a LIMS or computer, and/or generate a paper copy of the digital electronic display to document the numerical values of the pH test results. Section 11.19 describes the requirements for a certified laboratory to report results to an MRO. One commenter was opposed to requiring an HHS-certified laboratory to provide the concentration of a drug in a specimen at the time the test result is reported to the MRO. The Department disagrees and believes this policy is appropriate because, in keeping with the paperwork reduction and elimination acts, it eliminates the need for the MRO to generate a request in writing to obtain the concentrations for positive specimens. One commenter stated that reporting a positive and invalid result on the same specimen is confusing and recommended that the positive result and “the reason for the invalid result” be reported, rather than using the term “invalid result” along with the reason for the invalid result. The Department recognizes that requiring the laboratory to report both results to the MRO may be confusing; however, the MRO must discuss both results with the donor. The invalid result may only have an impact on the testing of the split specimen if requested by the donor. One commenter recommended that specific guidance be included on the content of any computer-generated report. The Department does not believe detailed guidance is needed, but has revised the appropriate Section 11.19(o) to state that the computer-generated report must contain sufficient information to ensure that the test result is properly associated with the Federal CCF that the MRO received from the collector. The Department added Section 11.19(g) to maintain the policy in the current Guidelines which requires the laboratory to contact the MRO prior to reporting specimens meeting certain “invalid result” criteria. This policy is important to ensure that the laboratory and the MRO discuss those specimens for which a positive or adulterated result could be determined, using different or additional tests at another certified laboratory. If additional testing does not appear to be feasible, the laboratory reports the invalid result. The MRO can initiate action immediately upon receipt of the report, in accordance with Section 13.4. Section 11.20 describes how long a certified laboratory must retain a specimen. Section 11.20(c) was revised to require a Federal agency to specify a period of time rather than “an additional period of time” when requesting a laboratory to retain a specimen beyond the normal one year specimen storage period. Also, the statement that a laboratory must maintain any specimen under legal challenge for an indefinite period of time has been deleted. The laboratory must be instructed by the agency as to the period of time the specimen under legal challenge will need to be retained beyond the normal one year storage period. Section 11.21 describes how long a certified laboratory must retain records. This section has been revised to specify the records that the HHS-certified laboratory must maintain when there is a legal challenge to the test result for a particular specimen. The revision allows a Federal agency to request a laboratory to maintain a copy of the documentation package for the specimen result being challenged for a specified period of time. The revision also permits the HHS-certified laboratory to retain records other than those included in the documentation package beyond the 2 year period of time that records are normally maintained. Section 11.22 describes the statistical summary report that a certified laboratory must provide to an agency. The summary report is the same as the report described in the current and Proposed Revisions to Mandatory Guidelines. Four commenters expressed concern with requiring an HHS-certified laboratory to make qualified personnel available to testify in a proceeding against a Federal employee. They were concerned that several individuals may be required to testify, thereby disrupting the laboratory's ability to continue testing specimens. The Department agrees and has revised Section 11.22(d) to require an HHS-certified laboratory to make only one qualified individual available to testify. This change is consistent with what normally happens in proceedings where laboratory results are being challenged by a donor. Section 11.23 describes the information a laboratory must make available to a Federal employee. The Department has revised this section to require that the curriculum vitae for the responsible person(s) be included along with the curriculum vitae for the certifying scientist that certified the test result. Section 11.24 describes the type of relationship that is prohibited between a certified laboratory and an MRO. Three commenters recommended that this section be revised to include additional restrictions or requirements that can be found in other regulated programs. The Department believes the requirements are sufficient to ensure that an MRO would report a potential problem with an HHS-certified laboratory to a Federal agency or to the appropriate regulatory office within HHS. In addition, the requirements in this section have been used successfully by HHS in previous versions of the Guidelines. The section has been reworded to clarify the requirements. Section 11.25 was added, addressing the type of relationship allowed between an HHS-certified laboratory and an IITF. This section was added for clarity, and is consistent with the requirements specified in the IITF sections of the Proposed Revisions to Mandatory Guidelines. The Department removed the requirement that a certified laboratory must inform its private sector clients when it uses testing procedures different from those used for Federal agency specimens. Although this requirement has been a program policy for many years, the Department is confident that HHS-certified laboratories would not intentionally mislead their private sector clients into believing that regulated procedures would be used to test their specimens when, in fact, less stringent procedures are being used. Subpart L—Instrumented Initial Test Facility (IITF) Section 12.1 describes what an HHS-certified IITF must include in its standard operating procedure manual. The requirements in this section are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines, except a 2 year period was specified for retaining archived SOPs, consistent with the requirement for laboratories in Section 11.1. Section 12.2 describes the responsibilities of the responsible technician (RT). The Department moved the requirement that the RT qualify as a certifying technician to Section 12.3(e), because this is a qualification rather than a responsibility. All other requirements in this section are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines. Section 12.3 describes the qualifications that the RT must have. One commenter recommended that the qualifications for the RT be the same as those for an alternate RP working in an HHS-certified laboratory. The Department disagrees with the recommendation because the qualifications for an alternate RP include responsibilities and expertise in technical areas (i.e., confirmatory testing) that the RT does not need to know to fulfill the responsibilities as an RT. However, the requirements are similar to those of a CS at an HHS-certified laboratory in Section 11.5. The requirement that the RT qualify as a certifying technician ensures that the RT can properly review the same results that a certifying technician reviews and reports at an HHS-certified laboratory or IITF. Section 12.4 describes what happens when the RT is absent or leaves an HHS-certified IITF. The Department has revised Section 12.4(c) to state that an alternate RT must be found acceptable during an on-site inspection of the IITF. This requirement ensures that the alternate RT is pre-approved. The Department believes an individual must be pre-approved as an alternate RT to ensure that someone with the appropriate knowledge and qualifications can assume RT responsibilities when the RT is absent from the IITF. Section 12.5 describes the qualifications an individual must have to certify a result reported by an HHS-certified IITF. The requirements in this section are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines, and are the same as those for a CT in a laboratory, specified in Section 11.5(b). Section 12.6 describes the qualifications and training other personnel must have who work in an IITF. The requirements in this section are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines, except that the Proposed Revisions to Mandatory Guidelines did not specifically state that the training must be documented. Section 12.7 describes the security measures that an HHS-certified IITF must maintain. The Department has revised this section to require the authorized escort to enter his or her name in the record used to document the entry of authorized visitors. These requirements are the same as for an HHS-certified laboratory, as specified in Section 11.7. The change in this requirement clarifies that the record must always indicate all of the individuals who may have had access to specimens maintained in secure areas. It is not any different than requiring any employee (whether serving as an escort or not) to document every time he or she enters or leaves a secured area. Section 12.8 describes internal IITF chain of custody requirements. The requirements in this section are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines. Section 12.9 describes the requirements for an initial drug test used by an HHS-certified IITF. The Department has added this section to ensure that the drug tests used by an HHS-certified IITF satisfy the same initial drug test requirements as required for HHS-certified laboratories. Section 12.10 was added to describe validation requirements for initial drug tests in an HHS-certified IITF. The requirements are the same as for initial drug tests in an HHS-certified laboratory. Section 12.11 describes the batch quality control requirements for initial drug tests in an IITF. These are the same as the requirements in the Proposed Revisions to Mandatory Guidelines, in that the requirements are the same as for an HHS-certified laboratory. For clarity, this section has been revised to list the required quality control samples, rather than referring to the relevant laboratory section. A single section, Section 13.14, was included in the Proposed Revisions to Mandatory Guidelines to address specimen validity testing in IITFs, referring to the relevant laboratory sections. The Department has expanded the information into three sections to address the requirements in a manner consistent with the format of Subpart K for HHS-certified laboratories. Section 12.12 addresses the IITF analytical and quality control requirements for specimen validity tests, specifying that testing is performed on a single aliquot. Since IITFs do not report adulterated, substituted, or invalid specimens, there is no need to perform two tests on separate aliquots, as required in a laboratory. Section 12.13 describes the validation requirements for specimen validity tests. The requirements in this section are the same as for an HHS-certified laboratory. Section 12.14 describes the requirements for an HHS-certified IITF to conduct each specimen validity test. One commenter recommended that an HHS-certified IITF be permitted to use a pH screening test to determine the pH rather than requiring the use of a pH meter. The Department agrees and has specified in this section that an HHS-certified IITF may use a pH screening test to determine if an initial pH validity test must be performed. The HHS-certified IITF will forward specimens with pH test results outside the acceptable range to an HHS-certified laboratory where the laboratory will conduct the initial pH validity test and, if needed, the confirmatory pH validity test. This policy permits an HHS-certified IITF to determine pH without a requirement to have a pH meter available for conducting the initial pH test. Section 12.15 describes the requirements for an HHS-certified IITF to report a negative or rejected for testing result to an MRO. One commenter recommended that this section be revised to allow an HHS-certified IITF to report a urine specimen that is negative/dilute to the MRO. The Proposed Revisions to Mandatory Guidelines stated that only a negative result could be reported by an HHS-certified IITF to an MRO. The Department agrees and has revised the section to permit an HHS-certified IITF to report negative, negative/dilute (when creatinine is greater than 5 mg/dL), and rejected for testing results directly to the MRO. All other requirements in this section are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines. Section 12.16 describes how an HHS-certified IITF handles a specimen that tested as positive, adulterated, substituted, or invalid at the IITF. The Department has revised this section by removing the proposed requirement for the HHS-certified IITF to record these types of results on the OMB-approved chain of custody form. The Department revised the Guidelines (Section 11.10) to require an HHS-certified laboratory to perform both initial and confirmatory testing for specimens received for testing from an IITF. Section 12.17 describes how long an HHS-certified IITF must retain a specimen. The Department added this section to specifically state that an HHS-certified IITF is permitted to discard specimens that are reported negative, negative/dilute, or rejected for testing. This policy is the same as those for an HHS-certified laboratory. Section 12.18 describes how long an HHS-certified IITF must retain records. The Department has revised Section 12.18(b) to specify the records that the HHS-certified IITF must maintain when there is a legal challenge to the test result for a particular specimen. The revision requires a Federal agency to specify the period of time that an IITF must maintain a copy of the documentation package (as described in Section 12.20) for the specimen result being challenged rather than requiring an indefinite period of time as stated in the Proposed Revisions to Mandatory Guidelines. Section 12.18(c) was added to permit an HHS-certified IITF to retain records other than those included in the documentation package beyond the 2 year period of time that records are normally maintained. Section 12.19 describes the statistical summary report that an HHS-certified IITF must provide semiannually to an agency. One commenter noted that this section must be revised because an HHS-certified IITF cannot report an invalid result. The Department agrees and has revised this section to clarify that an IITF indicates the number of specimens that were reported negative, negative/dilute, and rejected for testing on the statistical summary report. The Department also revised the section to clarify that an IITF indicates the number of specimens forwarded to an HHS-certified laboratory for additional drug and/or specimen validity testing. Three commenters raised concern with the proposed requirement that an HHS-certified IITF must make available qualified personnel to testify in a proceeding against a Federal employee when that proceeding is based on a test result reported by the HHS-certified IITF. The Department agrees and has revised the policy to specifically indicate that one qualified individual must be made available to testify. This change is consistent with what normally occurs in legal proceedings and is consistent with the policy that applies to an HHS-certified laboratory. Section 12.20 describes the information an IITF must make available to a Federal employee. The Department has revised this section to require that the curriculum vitae for the responsible technician be included along with the curriculum vitae for the certifying technician that certified the test result. Section 12.21 describes the type of relationship that is prohibited between an HHS-certified IITF and an MRO. The policy in this section is the same policy as described in the Proposed Revisions to Mandatory Guidelines. This section was reworded to clarify the requirements. Section 12.22 describes the type of relationship that can exist between an HHS-certified IITF and an HHS-certified laboratory. Three commenters raised concern over allowing any type of relationship to exist between an HHS-certified IITF and an HHS-certified laboratory. The Department believes any relationship is acceptable because HHS-certified laboratories and IITFs are certified independently. Therefore, the Department has no objection if an HHS-certified laboratory wants to establish and own one or more HHS-certified IITFs. Subpart M—Medical Review Officer (MRO) Section 13.1 describes who may serve as an MRO. Several commenters disagreed with the proposed policy in Section 13.1(b) to require MRO organizations to submit their training programs for review and approval by HHS before their trained MROs would be permitted to serve as MROs for Federal agencies. Other commenters stated that the Guidelines should include objective criteria that will be used to assess and approve the MRO organization's training programs. The Department believes that approving these MRO training courses is necessary to ensure that MROs receive all the information needed to properly evaluate drug test results and that they demonstrate and document their knowledge of the drug testing program by passing an examination. With regard to the criteria used by HHS to assess these training courses, the training requirements in Section 13.2 will serve as the basis for approving each MRO organization's training course. Section 13.2 describes the training requirements before a physician can serve as an MRO. The training requirements in this section will serve as the basis for approving an MRO organization's training course. HHS approval will focus on how well the course presents the materials for each requirement listed in this section and how well the organization documents each MRO's understanding of the material by examination. Section 13.3 describes the responsibilities of an MRO. The Department revised this section to address the requirement for the MRO to medically evaluate donors who were unable to provide a sufficient amount of urine for a drug test, as described in Section 13.5 and to address the requirement for the MRO and laboratory to discuss specimens meeting certain “invalid result” criteria, as described in Section 11.19(g). One commenter pointed out that the preamble for the Proposed Revisions to Mandatory Guidelines required the MRO to review 5 percent of the negative results reported by staff to ensure that the staff is properly performing the review process, but the text did not specify the 5 percent requirement. The Department has revised Section 13.3(a) to include this requirement. Three commenters recommended deleting the sentence which stated that “The MRO must cancel the result for any agency's specimen that is not collected or tested in accordance with these Guidelines.” The commenters believed it places a burden on MROs to be finders of fact concerning alleged irregularities at the collection site. The Department agrees and has deleted the sentence. Section 13.4 describes what an MRO must do when reviewing a drug test result. Three commenters stated that the proposed section referring to invalid results reported by an HHS-certified IITF should be revised, because IITFs will not report such results. The Department agrees and has deleted any reference to an HHS-certified IITF reporting an invalid result in Section 13.4. If an HHS-certified IITF finds a presumptive invalid result for a specimen, the IITF must forward the specimen to an HHS-certified laboratory for testing. Recent research supports that high temperature for an extended time may increase urine pH up to 9.5. This means that conditions during specimen transport and/or storage may cause pH to fall within the invalid range (i.e., greater than or equal to 9.0, but less than 11.0). The Department has added guidance to MROs in paragraph f of this section on interpreting an invalid result based on pH in the range of 9.0 to 9.5. This allows the MRO to consider time and temperature as an alternative, non-medical explanation for this invalid result. The Department has removed the sections addressing MRO actions in response to a second specimen collected after an invalid result for which there is no valid medical explanation. The Department will provide detailed guidance for MROs outside of these Guidelines. The Department added new Sections 13.5 and 13.6 to describe action the MRO must take when a collector reports that a donor was unable to provide a sufficient urine specimen. Sections 8.5(b)(2) and 8.6(e)(2)(ii) require the collector to document when a donor did not provide a urine specimen or when a donor provided an insufficient amount (i.e., less than 45 mL). Section 13.5 provides a detailed description of what the MRO and the Federal agency must do to determine the reason for the donor's inability to provide a urine specimen. Section 13.6 describes what the MRO and the Federal agency must do when a donor has a permanent or long-term medical condition that precludes him or her from providing a sufficient specimen when a negative result is required (i.e., for a Federal agency applicant/pre-employment test, a follow-up test, or a return-to-duty test). Section 13.7 describes when the donor has the opportunity to request the testing of a split (Bottle B) specimen. The policy in this section is the same policy as described in the Proposed Revisions to Mandatory Guidelines. Section 13.8 describes how an MRO reports a primary (Bottle A) specimen test result to an agency. The requirements in this section are the same as those described in the Proposed Revisions to Mandatory Guidelines. Section 13.9 describes the type of relationship that is prohibited between an MRO and an HHS-certified laboratory or an HHS-certified IITF. The Department has revised the question and policy in this section to delete references to a POCT. Subpart N—Split Specimen Tests Section 14.1 describes when a split specimen may be tested. Several commenters disagreed with the requirement that the donor must request the testing of his or her split specimen in writing. The commenters believe the requirement places an unreasonable burden on the donor and may cause unnecessary delays in testing and reporting split specimen results. The Department agrees that requiring a written request may be an obstacle to getting the split specimen tested in a timely manner and, therefore, has revised Section 14.1(b) to allow the MRO to have a split specimen tested based on a verbal request from the donor. However, the MRO is required to document in his or her records (e.g., a donor interview sheet) that the donor made a verbal request. The Department believes this documentation is acceptable to ensure that the donor properly initiated the request within 72 hours after being informed of the result by the MRO. The Department has revised the proposed policy for MRO action when the split (Bottle B) specimen cannot be tested by a second laboratory (e.g., insufficient specimen, lost in transit, split not available, no second laboratory available to perform the test), The Proposed Revisions to Mandatory Guidelines (Section 15.1) had required the MRO to direct the agency to immediately collect another specimen in these cases. In response to comments received, the Department has revised this section, now Section 14.1(c), to require an immediate recollection under direct observation. This is consistent with the current Guidelines. Sections 14.2, 14.3, and 14.4 describe the requirements to test split specimens when the primary specimens are tested positive, adulterated, or substituted, respectively. The requirements in these sections are the same as the requirements described in the current and Proposed Revisions to Mandatory Guidelines. Section 14.5 requires the second certified laboratory to report the split specimen result directly to the MRO. The policy in this section is the same as the policy described in the Proposed Revisions to Mandatory Guidelines. Section 14.6 describes the specific action(s) that an MRO must take after receiving the split specimen result from the second certified laboratory. The actions described in this section are the same as the actions described in the current and Proposed Revisions to Mandatory Guidelines. Section 14.7 describes the different ways that an MRO can report split specimen results to an agency. The policies in this section are the same as those described in the Proposed Revisions to Mandatory Guidelines. Section 14.8 describes how long a certified laboratory must retain a split (Bottle B) specimen. The policy in this section is the same as the policy described in the Proposed Revisions to Mandatory Guidelines. Subpart O—Criteria for Rejecting a Specimen or Cancelling a Test Section 15.1 describes those discrepancies (i.e., “fatal flaws”) that require an HHS-certified laboratory or an HHS-certified IITF to report a urine specimen as rejected for testing. The fatal flaws described in this section are the same as those described in the Proposed Revisions to Mandatory Guidelines. Section 15.2 describes the discrepancies that require an HHS-certified laboratory or an HHS-certified IITF to report a urine specimen as rejected for testing unless the discrepancy is corrected. The discrepancies described in this section are the same as those described in the Proposed Revisions to Mandatory Guidelines. Section 15.3 describes the deficiencies that are not sufficient to require an HHS-certified laboratory or an HHS-certified IITF to reject a urine specimen for testing or for an MRO to cancel a test. Several commenters stated the requirement in this section directing an MRO to track the frequency of omissions and discrepancies to determine when a collector, laboratory, or IITF should take immediate corrective action to prevent the recurrence of an error was unduly burdensome. The Department believes this requirement is necessary because the MRO is the only individual who reviews all of the information before making a final determination and reporting a test result to an agency. If a collector, laboratory, or IITF continues to make the same error even though the error may be insignificant, eliminating the error on future Federal CCFs is preferable than having it appear on every Federal CCF. Section 15.4 describes the discrepancies that may require an MRO to cancel a test. Three commenters stated that this section contains correctable discrepancies that should be included in Section 15.2. The Department believes that the correctable discrepancies in this section cannot be included in Section 15.2 because they can only be identified as discrepancies by the MRO. The discrepancies in Section 15.2 are those that should be identified by the HHS-certified laboratory or HHS-certified IITF when the Federal CCFs and specimens are received for testing. Four commenters requested clarification in Section 15.4(c) and Section 15.4(d), respectively, on the consequences if the MRO does not obtain a statement from the certifying scientist that he or she inadvertently forgot to sign the Federal CCF and the HHS-certified laboratory or IITF did not retransmit a modified electronic report. The Department agrees and revised Sections 15.4(c) and (d) to require the MRO to cancel the test when the required corrective action was not taken. Subpart P—Laboratory or IITF Suspension/Revocation Procedures The requirements in this entire subpart are the same as the requirements described in the Proposed Revisions to Mandatory Guidelines. Executive Order 12866: Economic Impact In accordance with Executive Order 12866, the Department submitted the Guidelines for review by the Office of Management and Budget (OMB). However, because the Guidelines will not have an annual impact of $100 million or more, and will not have a material adverse effect on the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments, they are not subject to the detailed analysis requirements of Section 6(a)(3)(C) of Executive Order 12866. The Department asked the Department of Transportation (DOT) for its estimate of the annual economic impact of the revised Guidelines on their regulated entities. Specifically, DOT requires that certain industries (e.g., Federal Motor Carrier Safety Administration) use the drug testing standards for HHS-certified laboratories and HHS-certified IITFs under these Guidelines. The Department notes that lowering testing cutoffs for existing drugs and establishing capability to test for new drugs, such as MDMA, will not impose additional costs or burdens on DOT-regulated entities, since most laboratories currently use similar testing standards on many non-regulated client specimens. It is estimated that there may be 10 percent more users of amphetamines and cocaine identified using the lowered cutoffs and testing for new drugs. The incidence and prevalence of amphetamines and cocaine use are very low (approximately 19,000 amphetamines positive and approximately 40,000 cocaine positive specimens in more than 6,500,000 tests conducted in 2007) in the DOT-regulated industries, and identification of 10 percent more positives should not impose a significant economic impact or burden for either the testing or the MRO review of the results. Paperwork Reduction Act of 1995 These revised Guidelines contain information collections which are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA)(44 U.S.C. 3507(d)). The title, description and respondent description of the information collections are shown in the following sections with an estimate of the annual reporting, disclosure, and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Title: Mandatory Guidelines for Federal Workplace Drug Testing Programs. Description: The Mandatory Guidelines establish the scientific and technical guidelines for Federal workplace drug testing programs and establish standards for certification of laboratories engaged in drug testing for Federal agencies under authority of section 503 of Public Law 100-71, 5 U.S.C. 7301 note, and Executive Order 12564. Federal agencies test applicants to sensitive positions, individuals involved in accidents, individuals for cause, and random testing of persons in sensitive positions. The program has depended on urine testing since 1988; the reporting, recordkeeping, and disclosure requirements associated with urine testing are approved under OMB control number 0930-0158. In an effort to shorten the time for negative results to be reported to the Federal agency, the changes also establish criteria for an IITF that will only perform initial tests. Description of Respondents: Individuals or households; Businesses or other for-profit institutions; Not-for-profit institutions. The burden estimates in the tables below are based on the following number of respondents: 38,000 Federal agency applicants who apply for employment in testing designated positions, 100 collectors, 50 urine testing laboratories, 25 IITFs, and 100 MROs. Estimate of Annual Reporting Burden Section Purpose Number of respondents Responses/ respondent Hours/ response Total hours 9.2(a)(1) Lab or IITF required to submit application for certification 28 1 3 84 9.10(a)(3) Materials to submit to become an HHS inspector 25 1 2 50 11.4(c) Lab submits qualifications of new RPs and alternate RPs to HHS 75 1 2 150 11.22(a) Specifications for lab semi-annual statistical report of test results to each Federal agency 75 2 0.5 75 12.4(c) IITF submits qualifications of new RTs and alternate RTs to HHS 50 1 2 100 12.19(a) Specifies contents of IITF semi-annual statistical report to Federal agencies served 25 5 0.5 63 14.7 Specifies that MRO must report verified split specimen test results to the Federal agency 100 5 0.05 (3 min) 25 16.1(b); 16.5(a) Specifies content of request for informal review of suspension/proposed revocation of certification 1 1 3 3 16.4 Specifies information appellant provides in first written submission when lab or IITF suspension/revocation is proposed 1 1 0.5 0.5 16.6 Requires appellant to notify reviewing official of resolution status at end of abeyance period 1 1 0.5 0.5 16.7(a) Specifies contents of appellant submission for review 1 1 50 50 16.9(a) Specifies content of appellant request for expedited review of suspension or proposed revocation 1 1 3 3 16.9(c) Specifies contents of review file and briefs 1 1 50 50 TOTAL 384 654 The following reporting requirements are also in the Proposed Revisions to Mandatory Guidelines, but have not been addressed in the above reporting burden table: Collector must report any unusual donor behavior or unusual physical appearance of the urine specimen on the Federal CCF (Sections 8.4(3) and 8.6(d)(1)); collector annotates the Federal CCF when a specimen is a blind sample (Section 10.3(a)); and MRO notifies the Federal agency and HHS when an error occurs on a blind sample (Section 10.4(c)). SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to Federal agencies. Estimate of Annual Disclosure Burden Section Purpose Number of respondents Responses/ respondent Hours/ response Total hours 4.5(c) Collector is given name and phone of Federal agency point of contact 100 1 0.05 (3 min) 5 11.23(b) Information on drug test that lab must provide to donor through MRO 50 10 3 1,500 12.20(b) Drug test information that IITF must provide to donor through MRO 25 10 2 500 13.7(b) MRO must inform donor of right to request split specimen test when a positive, adulterated, or substituted result is reported 100 5 3 1,500 Total 275 3,505 The following disclosure requirements are also included in the Proposed Revisions to Mandatory Guidelines, but have not been addressed in the above disclosure burden table: The collector must explain the basic collection procedure to the donor and answer any questions (Sections 8.3(e) and (g)). SAMHSA believes having the collector explain the collection procedure to the donor and to answer any questions is a standard business practice and not a disclosure burden. Estimate of Annual Recordkeeping Burden Section Purpose Number of respondents Responses/ respondent Hours/ response Total hours 8.3, 8.4, 8.5, 8.6, and 8.7 Collector completes Federal CCF for specimen collected 100 380 0.07 (4 min) 2,660 11.8 and 11.19(a) and (o) Lab completes Federal CCF upon receipt of specimen and before reporting result 50 760 0.05 (3 min) 1,900 12.8(a) and 12.15(f) IITF completes Federal CCF upon receipt of specimen and before reporting result 25 1520 0.05 (3 min) 1,900 13.3(c)(4) MRO completes the Federal CCF before reporting result 100 380 0.05 (3 min) 1,900 14.1(b) MRO documents donor's request to have split specimen tested 300 1 0.05 (3 min) 15 Total 575 8,375 The revised Mandatory Guidelines contain a number of recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector (Section 4.3(a)(4)(ii)) and the documentation must be maintained in the collector's training file (Section 4.3(c)). SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a Federal agency specimen, the collector is required to provide a statement (Section 6.2(b)) explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H (Section 8.6(d)(1)) requires collectors to enter any information on the Federal CCF of any unusual findings during the urine specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries is included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden. Subparts K and L describe a number of recordkeeping requirements for laboratories and IITFs as [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE8-26726. Public record. Not legal advice.