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CSAP Technical Report - 15

Medical Review Officer Manual
for Federal Workplace Drug Testing Programs

Division of Workplace Programs
Center for Substance Abuse Prevention
Substance Abuse and Mental Health Services Administration
Department of Health and Human Services

This publication was prepared by the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Prevention (CSAP) Division of Workplace Programs.

The authors are Walter F. Vogl, Ph.D., and Donna M. Bush, Ph.D.

The primary objective of the technical report series is to facilitate the transfer of prevention and intervention technology between and among researchers, administrators, policy makers, educators, and providers in the public and private sectors.

All material appearing in this book, except quoted passages from copyrighted sources, is in the public domain and may be used or reproduced without permission from CSAP or the authors. Citation of the source is appreciated.

Note: This manual applies to Federal agency drug testing programs that come under Executive Order 12564 and the Department of Health and Human Services (HHS) Mandatory Guidelines. The Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) programs have drug testing program requirements that may differ from those required by HHS. Therefore, Medical Review Officers (MROs) must be aware of those differences in reviewing results for other federally regulated programs.

DHHS Publication No. (SMA) 97-3164

Printed 1997

Contents

 

Chapter

1. Introduction

2. Department of Health and Human Services Mandatory Guidelines and the Medical Review Officer (MRO)

3. Federal Custody and Control Form

4. The MRO Review Process

5. Specific Drug Class Issues

6. Specimen Issues

7. MRO Documentation and Recordkeeping

8. Additional MRO Responsibilities

Appendix

A. National Laboratory Certification Program

B. Federal Custody and Control Form

C. Sample MRO Forms

D. Examples of Case Studies

Chapter 1. Introduction

As set forth in the Mandatory Guidelines for Federal Workplace Drug Testing Programs initially published in the Federal Register on April 11, 1988 (53 FR 11970-11989) and revised in the Federal Register on June 9, 1994 (59 FR 29908-29931), an essential part of the drug testing program is the final review of results. A positive laboratory test result does not automatically identify an employee or job applicant as an illegal drug user. An individual with a detailed knowledge of possible alternative medical explanations is essential to the review of results. The Medical Review Officer (MRO) fulfills this function by reviewing the results with the donor and protecting the confidential nature of a donorís medical information.

Not only is the MRO a critical safeguard in Federal drug testing programs, the MRO also represents the first formal role of the physician in the prevention and deterrence of substance abuse. It is a new and important area of medical practice. The direct involvement of the physician in prevention opens new opportunities and approaches in deterring substance abuse.

The MRO's responsibility does not include ensuring that every aspect of an agency's drug testing program meets or exceeds regulatory requirements. The MRO can only ensure that his or her involvement in the review and interpretation of results is consistent with the regulations and will be forensically and scientifically supportable.

As with any clinical specialty, to ensure that current practice guidelines are followed, an MRO must keep abreast of new information and the regulations. It is recommended that practicing MROs maintain a Standard Operating Procedure to ensure consistency and improve overall quality of the review process. It is further recommended that MROs participate in continuing education activities and actively request and review current regulations and guidelines for any specific agency for which an MRO has professional responsibility. MROs may also have additional responsibilities according to contractual arrangements and should ensure familiarity with such requirements as well.

From initial requirements that an MRO be a licensed physician with knowledge of substance abuse disorders, practical requirements have evolved regarding the availability of various training programs and certification examinations. These programs ensure that MROs are familiar with current regulations and receive the latest information on interpreting drug testing results. Although there is no regulatory requirement for formal certification at the present time, the training courses offered by the various professional organizations have served a very important role in providing continuing education programs.

Note: For your information, the following professional organizations offer courses and information for licensed physicians who are interested in the Medical Review Officer specialty:

American College of Occupational and Environmental Medicine (ACOEM)

55 West Seegers Road

Arlington Heights, IL 60005

(847) 228-6850

 

American Society of Addiction Medicine (ASAM)

4601 North Park Avenue, Suite 101

Chevy Chase, MD 20815

(301) 656-3920

 

American Association of Medical Review Officers (AAMRO)

6320 Quadrangle Drive, Suite 340

Chapel Hill, NC 27514

(919) 489-5407

 

Note: The listing of these three organizations is not an endorsement of their programs by the Federal government nor is attendance at one of their courses a regulatory requirement before a licensed physician can serve as an MRO. Although certification is not required, it is encouraged to ensure that an MRO is familiar with all regulatory policies and procedures.

 

Note: This manual applies to Federal agency drug testing programs that come under Executive Order 12564 and the Department of Health and Human Services (HHS) Mandatory Guidelines. The Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) programs have drug testing program requirements that may differ from those required by HHS. Therefore, MROs must be aware of those differences in reviewing results for other federally regulated programs.

 

Chapter 2. Department of Health and Human Services Mandatory Guidelines and the Medical Review Officer (MRO)

 

 

A. Definition of an MRO

 

The Mandatory Guidelines (section 1.2) define an MRO as:

 

A licensed physician responsible for receiving laboratory results generated by an agencyís drug testing program who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individualís positive test result together with his or her medical history and any other relevant biomedical information.

 

HHS has determined that only individuals holding either a Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree may serve as MROs. Individuals with other degrees are not permitted to serve as MROs for federally regulated programs. With regard to knowledge of substance abuse disorders, the MRO must be knowledgeable in the medical use of prescription drugs and the pharmacology and toxicology of illicit drugs.

 

An additional requirement has been included in the revised Guidelines (paragraph 2.6(b)):

 

The MRO may be an employee of the agency or a contractor for the agency; however, the MRO shall not be an employee or agent of or have any financial interest in the laboratory for which the MRO is reviewing drug testing results. Additionally, the MRO shall not derive any financial benefit by having an agency use a specific drug testing laboratory or have any agreement with the laboratory that may be construed as a potential conflict of interest.

 

The purpose of this requirement is to prevent any arrangement between a laboratory and an MRO that would prevent the MRO from reporting a problem identified with a laboratoryís test results or testing procedures. Similarly, the laboratory is prohibited from entering into any agreement with an MRO that could be construed as a conflict of interest.

 

In all cases, the MRO must ensure that no compromise of confidentiality with respect to drug test results or medical information learned in the review of drug test results occurs due to circumstances within the scope of the MRO's control.

 

 

B. Responsibilities of an MRO

 

The MRO has the following responsibilities:

1. Review the information on the specimen Custody and Control Form (CCF) and determine that the information is forensically and scientifically supportable.

 

2. Interview the donor when required.

 

3. Make a determination regarding the test result.

 

4. Report the verified result to the agency (employer).

 

5. Maintain records and confidentiality of the information.

 

Note: A positive test result does not automatically identify a donor (i.e., an employee or job applicant) as an illegal drug user. The MRO must assess and determine whether an alternative medical explanation could account for the positive test result and that documents associated with the test result are forensically and scientifically supportable.

Chapter 3. Federal Custody and Control Form

 

 

All urine specimens must be collected while maintaining chain of custody. Chain of custody is the term used to describe the process of documenting the handling and storage of a specimen from the time a donor gives the specimen to the collector to the final disposition of the specimen. Chain of custody is also used to document the handling, storage, and disposition of an aliquot during its testing in the laboratory.

 

For specimens collected under the Mandatory Guidelines, an Office of Management and Budget (OMB) approved Custody and Control Form (CCF) must be used to document the collection of a specimen (Appendix B is an example of the CCF) at the collection site. The OMB-approved CCF can be supplied by a number of different sources (e.g., laboratories, collectors, MROs); however, it is usually provided by the laboratory.

 

Note: The OMB-approved CCF may not be modified.

 

Note: See the Urine Specimen Collection Handbook for Federal Workplace Drug Testing Programs (CSAP Technical Report 12, DHHS Publication No. (SMA) 96-3114, dated 1996) for a detailed discussion of the procedure used to collect a urine specimen. It may be ordered by contacting the National Clearinghouse for Alcohol and Drug Information (NCADI) at 1-800-729-6686 or downloaded through the Internet at the NCADI web site (www.health.org/workpl.htm).

 

The CCF consists of the following seven copies with the color of each copy noted in parentheses:

 

Copy 1. Original - Must Accompany Specimen to Laboratory (White)

Copy 2. 2nd Original - Must Accompany Specimen to Laboratory (White)

Copy 3. Split Specimen - Must Accompany Split Specimen to Laboratory (White)

Copy 4. Medical Review Officer Copy (Pink)

Copy 5. Donor Copy (Green)

Copy 6. Collector Copy (Yellow)

Copy 7. Employer Copy (Blue)

 

Note: Copy 3 is discarded when a split specimen collection is not used.

 

Note: If a Federal agency elects to use a split specimen collection procedure, a split specimen is obtained when urine from a single void is divided into two specimen bottles. The first or primary specimen (Bottle A) must contain at least 30 mL of urine and the second or split specimen (Bottle B) must contain a minimum of 15 mL.

 

Copy 1 accompanies the specimen to the testing laboratory and serves as the testing record maintained by the laboratory, Copy 2 goes initially to the laboratory and then to the MRO with the test results from the laboratory, Copy 3 accompanies the split specimen (if collected) to the testing laboratory, Copy 4 is sent to the MRO directly from the collection site with donor identifying information, Copy 5 is given to the donor at the collection site, Copy 6 is retained by the collector, and Copy 7 is forwarded to the employer.

Note: Upon completion of laboratory testing, the laboratory may send Copy 2 of the CCF to the MRO a number of different ways (e.g., express mail, courier, facsimile, electronic transmission). The MRO may not report results to the employer until the original Copy 2 is received.

 

After a specimen is collected, the collector sends the specimen bottle along with the appropriate copies of the CCF to the laboratory for testing and Copy 4 is sent directly to the MRO. For single specimen collections, Copy 1 and Copy 2 accompany the specimen bottle to the laboratory. For split specimen collections, Copy 1, Copy 2, and Copy 3 are sent to the laboratory.

 

The CCF is completed as follows:

 

Step 1. This step is completed by the collector. The following information is required: name, address, and identification number (if applicable) of the employer; specific name and address of the MRO; donor's social security number or other employee identification number; reason for the test; and tests to be performed.

 

Step 2. This step is completed by the collector. The collector is required to measure the temperature of the specimen within four minutes after receiving the specimen from the donor. If the temperature is within the acceptable range, the "Yes" box is checked. If the temperature is outside the acceptable range, the "No" box is checked and the actual temperature is recorded. When this occurs, it may only be possible to indicate that the actual temperature is greater than or less than the highest or lowest temperature indicated on the measuring device.

 

Step 3. This step is completed by the collector and donor.

 

Step 4. This step is completed by the donor. On Copy 4 of the CCF, the donor provides a daytime phone number, evening phone number, date of birth, printed name, signature, and date of collection. The donor should read the statement on the CCF before providing a signature.

 

Note: In the event that the donor refuses to sign Copy 4, the collector must provide an appropriate comment on the "REMARKS" line in Step 5.

 

Step 5. This step is completed by the collector. The following information is provided: name, address, and phone number of the collection facility; printed name and signature of the collector; date of collection; time of collection; a block to check whether the collection was a single or split specimen collection. This section also has a "REMARKS" line to allow the collector to annotate any problems that may have occurred during the collection.

 

Step 6. This step is initiated by the collector and completed as necessary thereafter. This section is used to document the transfer and handling of the specimen(s) at the collection site. The first transfer of the specimen occurs when the donor gives the specimen container/bottle to the collector. On the first line, the collector records the date and prints and signs his or her name in the column labeled "SPECIMEN RECEIVED BY." This should occur contemporaneously (i.e., immediately before or after receiving the specimen from the donor). After sealing the single specimen bottle or split specimen bottles, the collector must complete the second line of Step 6 and indicate the specific name of the carrier to which the specimen package will be released before sealing the specimen/split specimens and copies of the CCF in a shipping container/package.

 

Note: Since the specimen/split specimens are sealed in a package that would indicate any tampering during transit to the laboratory and couriers, express carriers, and postal service personnel do not have access to the specimen/split specimens or copies of the CCF, there is no requirement that such personnel document chain of custody for the package during transit. After the specimen/split specimens are sealed in the shipping container/package, chain of custody annotations stop until the shipping container is opened and an individual at the laboratory has access to the specimen/split specimens and copies of the CCF.

 

Step 7. This step is completed by the laboratory after testing the specimen. The laboratory must report the result as either "NEGATIVE," "POSITIVE" for a specific drug, or "TEST NOT PERFORMED." For "TEST NOT PERFORMED," the laboratory must document the reason by providing an appropriate comment on the "REMARKS" line in Step 7.

 

Note: When a specimen is received with a discrepancy, the laboratory should immediately contact the collection site to determine if the discrepancy can be recovered. If the collection site can provide a "Memorandum For Record (MFR)" to recover the discrepancy, the laboratory is permitted to test the specimen, but must hold the results until the MFR is received. If the discrepancy cannot be recovered by a MFR from the collection site, the laboratory may not test the specimen and must indicate the reason on the "REMARKS" line. This notification also alerts the collection site that an error has been made and that the collection site must implement corrective action to prevent the recurrence of the discrepancy. The laboratory should include a copy of the MFR with its report to the MRO to ensure that the MRO is aware that the discrepancy has been recovered.

 

Note: In Step 7, the laboratory only indicates the drug for which a specimen was positive without giving the concentration. Since there is no reliable information available regarding the dose taken by the donor, when the dose was taken, or the route of administration, the concentration cannot be used to make those determinations (i.e., a high concentration is not "more positive" than a lower concentration). In all cases, a positive result proves that a drug or drug metabolite is present in the specimen above the established testing level.

 

Step 8. This step is completed by the MRO.

Chapter 4. The MRO Review Process

 

 

A. Review Custody and Control Form

 

The MRO and the laboratory have separate and independent responsibilities to review the CCF because each has access to some information that is not available to the other (e.g., Copy 4 of the CCF (the MRO copy) contains the donorís name and telephone number while the laboratory receives the specimen bottle and must inspect the bottle for evidence of tampering).

 

Note: Both the laboratory and the MRO may report "TEST NOT PERFORMED," but the MRO is the only individual authorized to report a "TEST CANCELED" result.

 

The MRO must review Copy 4 of the CCF to ensure that:

 

1. The OMB-approved CCF was used for the specimen collection.

 

2. The CCF has a preprinted specimen ID number at the top of the form along with the name and address of the laboratory testing the specimen.

 

3. Step 1 has the employer name and address, the MRO name and address, donor SSN or other ID number, reason for the test, and the tests to be performed.

 

4. The collector marked one of the temperature boxes in Step 2 on the CCF.

 

5. Step 5 on the CCF gives the name, address, and phone number of the collection facility, the collectorís printed name and signature, and the date and time for the collection. The "REMARKS" line may have a comment if a problem occurred during the collection.

 

6. Step 6 on the CCF indicates that the collector received the specimen from the donor and then released it to a specific courier for shipment to the laboratory.

 

7. Step 4 on the CCF gives the donor identifying information (i.e., printed name, signature, date signed, daytime phone number, business phone number, and date of birth).

 

If Copy 4 of the CCF contains all the required information, it indicates that the collector followed the appropriate collection procedure. At this point, the MRO waits to receive Copy 2 of the CCF from the laboratory.

 

Copy 2 of the CCF is similar to Copy 4 of the CCF with the following differences:

 

1. The laboratory testing the specimen has assigned an accession number that appears at the top of Copy 2 of the CCF.

 

2. Step 6 on the CCF has a third line completed by the laboratory showing that the specimen had been accessioned by the laboratory and possibly a fourth line transferring the specimen to temporary storage.

3. Step 7 on the CCF indicates the status of the specimen bottle seal(s) and has the printed name and signature of the certifying scientist, date signed, and the test result. There may also be a comment on the "REMARKS" line if the laboratory identified a problem with the specimen.

 

The consistency of the information on Copy 2 of the CCF, Copy 4 of the CCF, and any additional laboratory report must be established.

 

B. Review Laboratory Test Result

 

After receiving Copy 2 of the CCF from the laboratory, the MRO is required to make a determination regarding the test result. The action taken by the MRO will depend upon whether the test result reported by the laboratory is "NEGATIVE," "POSITIVE" for a specific drug, or "TEST NOT PERFORMED." Additionally, there may be other information on the CCF provided by the collector and/or the laboratory that might suggest a problem exists with the specimen.

 

Note: Many laboratories fax the Copy 2 of the CCF or transmit laboratory reports electronically to ensure that the MRO receives the results as soon as possible. This is acceptable and the MRO may begin the review process based on these reports; however, a final determination and report to the employer cannot be made until a hard-copy of the CCF (i.e., Copy 2 of the CCF) is received from the laboratory. Additionally, many laboratories provide a separate computer generated report that gives much of the same information contained on the Copy 2 of the CCF.

 

The action taken by the MRO for each type of result reported by the laboratory is as follows:

 

1. Negative Result

 

The MRO review of a negative laboratory test result includes a review of Copy 2 of the CCF, any additional laboratory report provided by the laboratory, and a comparison of this information to the information on Copy 4 of the CCF which was received directly from the collection site.

 

If all of the information appears correct and complete and no problems are noted by either the collector or the laboratory on the CCF, a negative laboratory test result is simply determined as a "NEGATIVE" by the MRO. The MRO completes Step 8 on Copy 2 of the CCF and reports the "NEGATIVE" result to the employer using the reporting procedure described later in this chapter (Section F).

 

If the MRO finds an administrative error on Copy 2 of the CCF or on Copy 4 of the CCF, the MRO reports a "NEGATIVE" result to the employer and includes an appropriate comment to describe the administrative error.

 

Note: When an MRO has informed the employer that an administrative error occurred, it is the employerís decision to accept the "NEGATIVE" result as a valid drug test result or to request that the MRO get a Memorandum For Record (MFR) to recover/correct the administrative error.

 

Note: When a laboratory receives a specimen from a collector and finds that the collector has made an administrative error on the CCF, the laboratory must obtain a MFR from the collector to recover/correct the error before reporting the result to the MRO. The laboratory should include a copy of the MFR with Copy 2 of the CCF and the MRO should retain the MFR as part of the records retained for the specimen. Since the administrative error was properly recovered/corrected, the MRO is not required to inform the employer that an administrative error was made. If the collector could not provide a MFR, the laboratory is required to report a "TEST NOT PERFORMED" result and to provide an appropriate comment on the "REMARKS" line (Step 7, Copy 2 of the CCF) to explain why a drug test result was not reported.

 

If a laboratory provides information to suggest that a specimen may have been diluted or adulterated (e.g., the specific gravity, creatinine concentration, or pH may be outside the normal range for a urine specimen, or the urine contains an unspecified adulterant) along with the negative result, the MRO should verify the test result as "NEGATIVE" and provide the information to the employer regarding possible dilution or adulteration.

 

Note: HHS permits laboratories to provide factual results of any dilution/adulteration tests on the "REMARKS" line in Step 7 on Copy 2 of the CCF (e.g., specific gravity = 1.001, creatinine = 10 mg/dL). The laboratory may only provide these results if they are outside the normal range established by the laboratory.

 

Note: These dilution/adulteration test results do not affect the validity of the current "NEGATIVE" test result.

 

Note: If the MRO believes this information suggests the donor may have diluted or adulterated the specimen, the MRO may recommend to the employer that the next time the donor is selected for a drug test a direct observed collection may be authorized by the employer.

 

 

2. Positive Result

 

The MRO review of a positive laboratory test result includes a review of Copy 2 of the CCF and any additional laboratory report provided by the laboratory, a comparison of this information to the information on Copy 4 of the CCF which was received directly from the collection site, and an interview with the donor.

 

If all of the information on the CCF appears correct and complete, no problems are noted by either the collector or the laboratory on the CCF, and the donor is unable to provide a valid alternative medical explanation, a positive laboratory test result is determined as a "POSITIVE" by the MRO. The MRO completes Step 8 on Copy 2 of the CCF and reports the "POSITIVE" result to the employer.

 

Note: When a laboratory receives a specimen from a collector and finds that the collector has made an administrative error on the CCF, the laboratory must obtain a Memorandum For Record (MFR) from the collector to recover/correct the error before reporting the result to the MRO. The laboratory should include a copy of the MFR with Copy 2 of the CCF and the MRO should retain the MFR as part of the records retained for the specimen. Since the administrative error was properly recovered/corrected, the MRO is not required to inform the employer that an administrative error had been made. If the collector could not provide a MFR, the laboratory is required to report the result as "TEST NOT PERFORMED" and to provide an appropriate comment on the "REMARKS" line (Step 7, Copy 2 of the CCF) to explain why a drug test result was not reported.

 

If the MRO finds that the laboratory made an administrative error on Copy 2 of the CCF or failed to identify an administrative error made by the collector, the MRO should contact either the collector or the laboratory (whichever made the administrative error) to determine if the administrative error can be recovered/corrected by a Memorandum For Record (MFR) from the collector or the laboratory.

 

a. If the laboratory or the collector can provide a MFR to recover/correct the administrative error and the donor has not provided an alternative medical explanation for the positive result, the MRO verifies and reports the result as "POSITIVE" to the employer after the MFR is received and retains the MFR as part of the records associated with the testing of the specimen.

 

 

b. If the laboratory or the collector cannot provide a MFR to recover/correct the administrative error and the MRO believes that the administrative error has a significant impact on the validity of the entire collection and testing process, the MRO may determine that a "TEST CANCELED" result is more appropriate than a "POSITIVE" result. If the MRO believes the administrative error does not have a significant impact on the validity of the collection or testing process, the MRO may determine the result as a "POSITIVE." If the MRO believes the administrative error does not have a significant impact on the validity of the collection or testing process, the MRO may determine the result as a "POSITIVE."

 

Note: If a MFR cannot be obtained for a significant administrative error, the MRO should inform the employer that an administrative error occurred whether the laboratory positive test result is determined by the MRO as a "POSITIVE" or "TEST CANCELED." Additionally, the MRO must not inform the employer that a "TEST CANCELED" determination had been originally reported "POSITIVE" by the laboratory.

 

Note: When an MRO reports a "TEST CANCELED" result because the MRO believes that an administrative error has had a significant impact on the validity of the entire collection and testing process, it is the employerís decision whether or not to immediately collect another urine specimen from the donor. This situation does not justify using a direct observed collection procedure.

 

If a laboratory provides information to suggest that a specimen may have been adulterated or diluted (e.g., the specific gravity, creatinine concentration, or pH may be outside the normal range for a urine specimen, or the urine contains an unspecified adulterant) along with the positive result, the MRO should verify the test result as "POSITIVE" and provide the information to the employer regarding possible dilution or adulteration.

 

Note: HHS permits laboratories to provide "factual" results of any dilution/adulteration tests on the "REMARKS" line in Step 7 on Copy 2 of the CCF. The laboratory may only provide these results if they are outside the normal range established by the laboratory.

 

Note: These dilution/adulteration test results do not affect the validity of the current "POSITIVE" test result.

 

Note: If the MRO makes a "NEGATIVE" determination because the donor provides a valid alternative medical explanation for the positive laboratory drug test, the information regarding the dilution/adulteration testing should not be provided to the employer.

 

3. Test Not Performed Result

 

The MRO review of a "TEST NOT PERFORMED" result includes a review of Copy 2 of the CCF and any additional laboratory report provided by the laboratory and a comparison of this information to the information on Copy 4 of the CCF which was received directly from the collection site. Additionally, an interview with the donor may be necessary depending on the reason for the "TEST NOT PERFORMED" result.

 

A laboratory will report a "TEST NOT PERFORMED" result for any of the following reasons:

 

a. A significant administrative error was made by the collector on the CCF and the collector could not provide a MFR to recover/correct the error.

 

b. The specimen bottle leaked during transit and there was an insufficient volume to test the specimen.

 

c. The specimen bottle seal was not intact upon receipt by the laboratory.

 

d. The specimen ID number on the bottle label did not match the number on the custody and control form.

 

e. The laboratory was unable to obtain a valid test result (i.e., a negative or positive) for each initial test kit

 

Note: When the laboratory tests the specimen using its immunoassay test kits and cannot obtain a valid test result for each drug class, the laboratory is permitted to use a second, different immunoassay test in an attempt to obtain a valid initial test result. If valid initial test results cannot be obtained, the laboratory reports a "TEST NOT PERFORMED" result.

 

Note: When a laboratory is unable to obtain valid initial test results for the specimen and cannot specifically identify the cause, the MRO should contact the donor and ask the donor if he or she is taking any medications. Tolectin® (Tolmetin - a non-steroidal anti-inflammatory medication), Flagyl® (metronidazole - an antifungal and antibacterial agent), and Cipro® (ciprofloxacin - an antibacterial agent) are the only known prescription medications that may interfere with some immunoassay tests. If the donor is unable to give an explanation, unable to provide a valid prescription for one of the above medications, or denies having adulterated the specimen, the MRO should report the specimen as "TEST CANCELED" and inform the employer that another specimen should be collected using a direct observed collection to possibly determine the reason for not getting a valid analytical result. The direct observed collection should eliminate the possibility that the donor may have adulterated the first specimen. If the second specimen collected using direct observation exhibits the same behavior as the first specimen, the MRO again reports the result for the second specimen as a "TEST CANCELED" and recommends to the employer that no further action is required because the donor is either taking a valid prescription medication that interferes with the drug test or there is some unknown endogenous substance present in the donorís urine that prevents getting a valid initial test result.

 

 

f. A specimen tests positive for a drug/metabolite on one of the initial tests, but in confirmation appears to have an interfering substance which prevents the detection of the drug/metabolite and has no recovery of the internal standard.

 

Note: Normally, when a specimen is positive on an initial test but negative on a confirmatory test, the specimen is reported "NEGATIVE" without any additional information being provided to the MRO. However, when a specimen (either a single specimen or the Bottle A of a split specimen) appears to have an interferant that prevents the detection of the drug/metabolite in the confirmatory test and has no recovery of the internal standard even after multiple extraction attempts, the laboratory should report the result as "TEST NOT PERFORMED." In this case, the factual information provided to the MRO may be useful in determining if the specimen was adulterated at the collection site and whether a direct observed collection should be used the next time the donor is selected for a drug test.

 

g. The laboratory can demonstrate that a specific "adulterant" is present in the specimen that prevents obtaining valid test results.

 

Note: The MRO should proceed with the donor interview and give the donor an opportunity to explain the presence of the "adulterant." The MRO provides the information regarding the"adulterant" to the employer. This information may allow the employer to take the same action that a "POSITIVE" drug test result would allow.

 

When a "TEST NOT PERFORMED" result is reported, the laboratory must provide an appropriate comment on the "REMARKS" line (Step 7, Copy 2 of the CCF) to explain why the "TEST NOT PERFORMED" result was reported.

 

Note: Although a laboratory reports a "TEST NOT PERFORMED" result when it may have actually conducted tests on a specimen, the CCF only allows reporting a "NEGATIVE," a "POSITIVE," or a "TEST NOT PERFORMED" result.

 

An MRO will make a "TEST NOT PERFORMED" determination when the laboratory reports a "TEST NOT PERFORMED" result except as noted above.

 

C. Interview Donor

 

An essential element of the MRO review process is the opportunity given the donor to explain why the specimen tested positive or to explain why there may have been a problem regarding the validity of the specimen.

 

 

Note: From a practical standpoint, there is no need to contact a donor for a negative test result unless, as for a positive test result, there is some question as to the integrity of the specimen that was collected and tested by the laboratory.

 

Note: For a positive test result, the MRO must discuss the results with the donor unless the donor expressly declines the opportunity to speak with the MRO.

 

The MRO contact and interview with the donor should include the following steps:

 

1. The MRO or an assistant makes the initial contact with the donor as soon as possible after receiving the Copy 2 of the CCF from the laboratory indicating a positive result.

 

Note: There are no specific regulatory time lines, but most MROs make the first attempt to contact the donor within 24 hours after receiving either the electronic transmission or the hard copy of the CCF (Copy 2) from the laboratory.

2. The MRO or an assistant makes a positive identification of the donor when the donor is actually contacted (e.g., asks the donor to provide his or her SSN and date of birth).

 

Note: An assistant to the MRO may make the initial contact with the donor. This initial contact is useful since it is often time consuming to locate a donor, especially if the donor travels frequently or the donorís phone number is incorrect. The assistantís role should be limited to locating and making the initial contact with the donor. Once the donor is contacted and his or her identification is verified, the MRO must continue the interview.

 

3. The MRO tells the donor, before obtaining any information, that any confidential medical information provided by the donor during the review process may be disclosed to the employer if that information may affect public safety.

 

Note: This is analogous to reading the Miranda rights to an individual before being questioned after an arrest.

 

4. The MRO informs the donor that the laboratory has reported a positive test result for a given drug for his or her specimen.

 

Note: The MRO should be prepared to answer questions from the donor regarding chain of custody and testing procedures.

 

5. The MRO asks the donor if he or she had used any illegal drugs, had taken any prescription medications during the time of the urine collection, or if there is any possible explanation for the positive result. Generally, a donor will deny using an illegal drug and will attempt to convince the MRO that the positive is a result of legitimate prescription medication use or that the laboratory made an error.

 

Note: If the donor voluntarily admits to illegal drug use consistent with the test results, the MRO should advise the donor that a verified "POSITIVE" result will be reported to the employer.

 

Note: If the donor claims to have used a legally prescribed medication or the drug use was associated with a legitimate medical procedure, the MRO should require the donor to provide the appropriate documentation (e.g., medical record, doctor's report, copy of a prescription). The MRO should give the donor a deadline for submitting the medical information.

 

6. If the information submitted by the donor is sufficient to support the legitimate medical use of a prescription medication that would cause the positive test result for the drug reported by the laboratory, the MRO may immediately inform the donor that the result will be reported to the employer as a verified "NEGATIVE."

 

If the information submitted by the donor is not sufficient to support the legitimate medical use of a prescription medication that would cause the positive test result for the drug reported by the laboratory, the MRO may immediately inform the donor that the result will be reported to the employer as a verified "POSITIVE."

 

The MRO records the verified result in Step 8 on Copy 2 of the CCF and reports it as such to the employer.

 

Note: Once an MRO makes a determination, the MRO reports the result to the employer.

Note: Ideally, the MRO is always able to contact the donor, obtain the appropriate information, and make a determination during or immediately after the interview. However, this is not always the case. Occasionally, the MRO is unable to contact the donor for various reasons (e.g., the donor has moved, no longer works for the employer, or was a job applicant and cannot be located).

 

The MRO may verify a positive test as "POSITIVE" without having communicated directly with the donor (i.e., a non-contact determination) for the following reasons:

 

(1) The donor expressly declines the opportunity to discuss the test result.

 

(2) The MRO, after making all reasonable efforts, has not been able to contact the donor within 14 days of the date on which the MRO receives the positive test result from the laboratory.

 

(3) The MRO has contacted the employer to attempt to locate the donor. The employer contacted the donor and instructed the donor to contact the MRO, but the donor has not contacted the MRO within 5 days after being contacted by the employer.

 

The MRO should establish guidelines as to what constitutes a reasonable effort to contact the donor and should document all attempts that were made to contact the donor. When contacting the employer as part of the MROís efforts to contact the donor, the MRO should not reveal the test result or any information about the drug test. The employer should confidentially direct the donor to contact the MRO within 5 days and should inform the MRO once the donor has been so instructed or if unable to contact the donor.

 

7. If a split specimen was collected, the MRO informs the donor of the opportunity to request that the split specimen be tested.

 

If the donor requests the split specimen to be tested, the MRO directs the laboratory to send Bottle B to another certified laboratory for confirmatory testing.

 

Appendix C contains some sample forms to document the contact with the donor. These are only examples, but an MRO may find them useful in developing his or her own forms.

 

 

D. Retest Single Specimen/Test Split Specimen

 

Before making a determination on a positive test result, the Mandatory Guidelines permit an MRO to request a retest of a single specimen or the Bottle A specimen from a split specimen collection if there is any question regarding the accuracy or validity of the test result.

 

Note: The MROís request must be based on a review of technical information (provided by the laboratory or donor) that makes the MRO believe that the result may be scientifically insufficient and, therefore, believes that a retest would be useful before making the determination.

 

Note: The MRO can request that the retesting of the original specimen be performed by the same laboratory or that an aliquot of the single specimen be sent for a retest to another certified laboratory. The Mandatory Guidelines are silent with respect to who chooses the second laboratory. The only requirement is that the second laboratory is certified by HHS whether it is chosen by the agency/employer, donor, MRO, or the first laboratory.

 

Note: It is unacceptable for an MRO to automatically request a retest on every specimen. There must be a sound justifiable scientific basis for each retest request.

 

Note: Prior to making a determination, only the MRO is authorized to order a retest of a single specimen or the Bottle A of a split specimen.

 

To ensure that a specimen is available if a retest is requested either by an MRO or by an official administrative or judicial proceeding, HHS requires laboratories to place all specimens confirmed positive in properly secured frozen storage for a minimum of one year. This is generally a sufficient amount of time to allow for a retest to occur; however, the time may be extended beyond one year by either the employer or an administrative/judiciary official to allow completion of any litigation/arbitration that may be ongoing with the donor.

 

Note: If split specimens were collected, the laboratory keeps both specimen bottles frozen for one year. If Bottle B was sent to another laboratory for confirmatory testing, that laboratory retains Bottle B in frozen storage for one year.

 

For a split specimen collection, the MRO must inform the donor of his or her right to request an analysis of the split specimen (Bottle B). The donorís request to have the split specimen tested must be made through the MRO. Although the time allowed for a retest request may vary among agencies, the donor is normally given a maximum of 72 hours to initiate the request. This will ensure that the analysis of the split specimen is performed in a timely manner.

 

The MRO must request the retest of a single specimen or the testing of a split specimen in writing (i.e., a memorandum or letter format). The written request may be mailed, faxed, or electronically sent to the laboratory where the specimen was tested.

 

The request to retest a single specimen should contain the following information:

 

1. MRO name and address (use MRO letterhead)

 

2. Laboratory name and address (i.e., Laboratory A) where original analysis was performed

 

3. Specimen I.D. Number (i.e., number on the Custody and Control Form)

 

4. Laboratory Accession Number (i.e., the number assigned by Laboratory A to the specimen when it was accessioned)

 

5. Request confirmatory retest for the drug/metabolite reported by Laboratory A

 

Note: If the retest is to be performed at a different certified laboratory (Laboratory B), the MRO also includes the name and address of this certified laboratory. Laboratory B may be selected by the MRO, the employer in its contract with the laboratory that tested the single specimen (Laboratory A), or by the donor.

 

Note: The result of a retest of a single specimen is reported to the MRO by the laboratory performing this retest using an appropriate laboratory report form.

 

The request to test a split specimen (Bottle B) should contain the following information:

 

1. MRO name and address (use MRO letterhead)

 

2. Laboratory name and address (i.e., Laboratory A) where analysis of Bottle A was performed

 

3. Specimen I.D. Number (i.e., number on the Custody and Control Form)

 

4. Laboratory Accession Number (i.e., the number assigned by Laboratory A to the specimen when it was accessioned)

 

5. Request confirmatory test for drug/metabolite reported by Laboratory A

 

6. Name and address of the laboratory (i.e., Laboratory B) selected to test the Bottle B specimen

 

Note: Laboratory B may be selected by the MRO, the employer in its contract with Laboratory A, or by the donor.

 

Note: Laboratory B will report the result for the split specimen on Copy 3 of the CCF to the MRO who will report the result to the employer and the donor.

 

1. Retest Result For a Single Specimen

 

If the retesting of the original specimen fails to reconfirm the original laboratory result, the MRO will report the result as "NEGATIVE" to the employer.

 

Note: Since this retest was performed because the MRO had concerns regarding the validity of the positive test result initially reported by the laboratory, the MRO cannot make a final determination before the retest result is reported to the MRO by the laboratory.

 

Note: When a retest does not reconfirm the presence of a drug, the MRO should contact the appropriate regulatory office. The regulatory office will conduct an investigation to determine the reason for not reconfirming the presence of the drug and take necessary action to ensure that the laboratory implements corrective action to prevent the recurrence of such an error.

 

 

2. Retest Result For a Split Specimen

 

If the testing of Bottle B reconfirms the presence of the drug/drug metabolite, the MRO verifies the result for Bottle B as "RECONFIRMED" on Copy 3 of the CCF.

 

If the testing of Bottle B fails to reconfirm the result reported by the laboratory that tested the Bottle A specimen, the MRO shall report "FAILED TO RECONFIRM - BOTH TESTS CANCELED" on Copy 3 of the CCF

 

Note: Since the positive result for the Bottle A specimen had been reported to the employer by the MRO, the employer will be required to reverse any personnel action that may have been taken against the donor. Additionally, the donor reenters the group of individuals subject to random testing as if the test had not been conducted.

 

Note: The Federal agency should notify the appropriate National Laboratory Certification Program (NLCP) office whenever a "FAILED TO RECONFIRM" result has occurred on a Bottle B specimen. The NLCP office will investigate the "FAILED TO RECONFIRM" result and attempt to determine the reason for the inconsistent results. HHS will report its findings to the Federal agency including recommendations and/or actions taken to prevent the recurrence of the "FAILED TO RECONFIRM" result.

 

3. Special Situation Regarding Testing at Laboratory B

 

There is a technical problem that very occasionally occurs when Laboratory B retests an aliquot of a single specimen or tests a split specimen (Bottle B) that had been reported "POSITIVE" by Laboratory A. The drug is present in the specimen; however, Laboratory B is unable to reconfirm the presence of the drug or metabolite reported by Laboratory A because it uses a different analytical procedure and/or instrumentation. These differences occasionally prevent a Laboratory B from reconfirming the presence of a drug or metabolite because the analytical results do not satisfy all the criteria required to make a positive identification of the analyte.

 

Note: If Laboratory B believes that the drug or metabolite is present in the aliquot of the single specimen or the split specimen (Bottle B) that was received from Laboratory A, but cannot reconfirm the presence of the drug or metabolite, Laboratory B, after consultation with the MRO, may send the aliquot of the single specimen or the split specimen under chain of custody to Laboratory C for confirmatory testing. The MRO may also request Laboratory A to send another aliquot of the single specimen to Laboratory C if there is an insufficient quantity of urine remaining in the aliquot of the single specimen tested at Laboratory B. Laboratory C should be selected such that it uses a confirmation method more similar to that used by Laboratory A.

 

E. Full Documentation Package

 

Occasionally, if the MRO has serious concerns regarding the validity of a test result, the MRO will need to review the complete package of analytical data, chain of custody records, and other administrative documents associated with a particular specimen. The MRO may request the laboratory to provide this information, generally referred to as a "full documentation package." A full documentation package should include copies of the batch test results that contain the test result for the donorís specimen, internal and external chain of custody documents for the batch of specimens that contain the donorís specimen, and any other relevant information pertaining to the testing of the donorís specimen.

 

Note: Although each full documentation package is different, it should contain all the information needed for the MRO to determine if the test result reported by the laboratory is, in fact, scientifically and forensically supportable.

 

Note: Since each full documentation package is different, the MRO is encouraged to contact the laboratory to discuss the information. The MRO may find that additional information (e.g., a description of the laboratoryís chain of custody procedures, a description of the laboratoryís quality assurance program) would be helpful in reviewing the full documentation package and making a final determination.

 

The MRO should review: the chain of custody documents for the specimen bottles to ensure that their handling was properly documented during accessioning, storage and disposal; the internal chain of custody documents associated with the handling of the aliquots to ensure that their handling was properly documented during the testing; and the batch test results to ensure that they contain the test results for the calibrators and controls that were analyzed with the donor specimens.

 

F. Report Verified Result to Employer

 

The MRO must report all verified results in writing to the employer. The written report may be sent by mail, courier, facsimile, or secured electronic means to the employer. However, if secured electronic means or a facsimile is used to quickly report a result, a hard-copy of the report must also be mailed or sent by courier.

 

The MRO report must include, at a minimum, the following: donor name and/or SSN, specimen I.D. number from the CCF, the verified test result (if positive, list specific drug(s)), the MROís printed name and signature, and the date the determination was made.

 

Note: The MRO may use a photocopy of Copy 4 of the CCF (i.e., assuming that the information on Copy 4 is legible), a memorandum, or a letter format to report a result to the employer.

 

If a memorandum or letter format is used, the MRO may list results for several specimens on one memorandum or letter. There is no requirement that a separate report be prepared for each result reported to an employer.

 

Note: Under no circumstance should Copy 2 of the CCF be sent to the employer to report results. The reason is that Copy 2 would indicate which specimens had been reported "POSITIVE" by the laboratory, but were verified "NEGATIVE" by the MRO. Using a separate MRO report to report all results will ensure the confidentiality of the laboratory reported "POSITIVE" results that were verified as "NEGATIVE" results by the MRO.

 

Note: The MRO report may include relevant comments provided by the collector and/or laboratory on the CCF as well as other information, such as, documentation of attempts to contact the donor or a statement of the donor's refusal to cooperate with the medical review process. The MRO may add any information provided by the donor (especially at the donor's request) to the verified result report. Such additional information should not, however, reveal specific confidential medical information unless that information may affect public safety.

 

The OMB-approved Federal Drug Testing Custody and Control Form requires the MRO to verify the result reported by the laboratory as either "NEGATIVE," "POSITIVE," "TEST NOT PERFORMED," or "TEST CANCELED."

 

Note: A verified result may not be reported to the employer until the MRO has completed the review process.

 

If the MRO review includes a need to discuss the result with the donor, the following exceptions allow the MRO to verify a result without discussing it with the donor:

 

1. The donor refuses to discuss the result with the MRO.

 

Note: The MRO would verify the result reported by the laboratory and provide a comment to the employer stating that the donor refused to discuss the result.

 

2. The MRO is unable to contact the donor and, therefore, requests the employer to have the donor contact him or her to discuss the drug test result.

 

Note: Once the MRO contacts the employer for assistance in contacting the donor, the MRO waits a reasonable time (e.g., 5 days) for some response. If the employer has not indicated that the donor was contacted and the MRO has not heard from the donor, the MRO may verify the test result reported by the laboratory and provide a comment regarding the inability to contact the donor.

 

Note: A verified result that is reported without contacting the donor must include information documenting the attempts that were made to contact the donor.

 

G. Occupational and Public Safety

 

Executive Order 12564 used the term "illegal drugs" to refer to any controlled substance that was included in Schedule I or II of the Controlled Substances Act. The Executive Order also stated that the term illegal drugs "does not mean the use of a controlled substance pursuant to a valid prescription or other uses authorized by law."

 

Note: The purpose of this policy is to ensure that in a drug-free workplace program, drug testing does not identify an individual who is receiving legitimate medical care and, thereby, provides confidential medical information to an employer or anyone else.

 

However, there is a public safety issue associated with information that a donor may provide to an MRO during the review of a drug test result. That is, the donor may be taking a legal prescription medication as treatment for a medical condition. This medication may have possible side effects that may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks (e.g., driving a car or truck, operating machinery).

 

Note: If the side effects of a legitimately prescribed medication have a possible impact on the safety aspects of the work performed by a donor, the MRO must decide what should be done with the information. Although the Guidelines require an MRO to verify a drug test result as a negative result if the donor has a legitimate alternative medical explanation, it is recommended that the MRO contact the prescribing physician to discuss the possible impact that the medication may have on the safety aspects of the work performed by the donor. Additionally, some occupations have restrictions that prohibit an individual from taking specific medications which may, otherwise, be allowable for other occupations. In these instances, the MRO may inform the individual responsible for certifying that the donor is qualified to perform that job that the donor is taking a medication that is restricted for an individual in that occupation or that the medication may affect the individualís ability to perform a safety sensitive occupation.

 

H. State Initiatives and Laws

 

State initiatives and laws which make available to an individual a variety of illicit drugs by a physicianís prescription or recommendation do not make the use of these illicit drugs permissible under the Federal Drug-Free Workplace Program. These State initiatives and laws are inconsistent with Federal law and put the safety, health, and security of Federal workers and the American public at risk.

 

The use of any substance included in Schedule I of the Controlled Substance Act, whether for non-medical or ostensible medical purposes, is considered a violation of Federal law and the Federal Drug-Free Workplace Program. These drugs have no currently accepted medical use in treatment in the United States and their uses are inconsistent with the performance of safety-sensitive, health-sensitive, and security-sensitive positions, and with other testing circumstances.

 

Note: Medical Review Officers shall not accept a prescription or the verbal or written recommendation of a physician for a Schedule I substance as a legitimate medical explanation for the presence of a Schedule I drug or metabolite in a Federal employee/applicant specimen.

Chapter 5. Specific Drug Class Issues

 

A. Amphetamines

 

1. Background

 

Amphetamine and methamphetamine are substances regulated under the Controlled Substances Act (CSA, 21 U.S.C. ß 801 et seq.), and implementing regulations as Schedule II stimulants (see 21 CFR ß 1308.12(d)). Schedule II substances have legitimate medical uses, but also have a high potential for abuse. Both drugs have been used for treating attention deficit disorder in children, obesity, and narcolepsy.

 

Amphetamine and methamphetamine are central nervous system stimulants. A single therapeutic dose often enhances attention and performance, but exhaustion eventually occurs and performance deteriorates as the effects wear off. Frequently, repeated high-dose use produces lethargy, exhaustion, mental confusion, and paranoid thoughts.

 

Tolerance can develop to the effects of amphetamine and methamphetamine. Therapeutically administered amphetamine and methamphetamine are usually taken orally as tablets or capsules. Absorption from the gastrointestinal and respiratory tract is good and they are distributed throughout the body. Abusers inject the drugs intravenously, sometimes take them by intranasal "snorting," and by smoking. A typical therapeutic dose is five milligrams. Individuals who abuse these drugs are reported to inject up to one gram in a single intravenous dose. Physical dependence is modest. Lethargy, drowsiness, hyperphagia, vivid dreams, and some mental depression may persist for a few days to several weeks after abrupt termination of repeated high doses.

 

2. Metabolism and Excretion

 

Nearly half of a methamphetamine dose is recovered from urine unchanged. A small percentage is demethylated to amphetamine and its metabolites. The excretion rate of methamphetamine is also increased when urine is acidic.

 

Amphetamine is excreted as both unchanged amphetamine and as hydroxylated metabolites. Typically, about one-quarter of an administered dose is excreted as unchanged amphetamine, but this varies widely with urinary pH; the drug stays in the body longer when urine is alkaline, allowing reabsorption and thus allowing more of it to be metabolized. In 24 hours, about 80 percent of a dose will be excreted if urine is acidic, while less than half is excreted if urine is alkaline.

 

A single therapeutic dose of amphetamine or methamphetamine can produce a positive urine for about 24 hours, depending upon urinary pH and individual metabolic differences. High-dose abusers may continue to generate positive urine specimens for 2 to 4, or more, days after last use.

 

Methamphetamine and amphetamine exist in two isomeric structural forms known as enantiomers. Enantiomers are non-superimposable mirror images. The two isomers of each substance are designated as d- (dextro) and l- (levo), indicating the direction in which they rotate a beam of polarized light. As do many pharmacological enantiomers, the d- and l- isomers have distinct pharmacological properties with different sites of action. In this case, the d- isomer of each substance has a strong central nervous system stimulant effect while the l- isomer of each substance has primarily a peripheral action. It should be noted that d-methamphetamine is metabolized to d-amphetamine and l-methamphetamine is metabolized to l-amphetamine.

 

Note: Generally, the methamphetamine/amphetamine result reported by the laboratory does not indicate which enantiomer is present because the laboratory procedure is set up to only identify and quantify the methamphetamine/amphetamine that is present. In order to determine which enantiomer is present, an additional analysis must be performed. This additional analysis which differentiates the isomers must be specifically requested.

 

The enantiomer identification may be useful in determining if a donor has been using a Vicks Inhaler®, a prescription medication, or abusing an illegal drug. The presence of the l- isomer of either amphetamine or methamphetamine does not by itself rule out illegal use.

 

Note: Illegally manufactured amphetamine and methamphetamine often contain significant amounts of the l- isomer of each substance. This depends on the starting materials used and the technical proficiency of the clandestine laboratories.

 

The following prescription medications contain d-amphetamine or racemic d,l-amphetamine (i.e., equal amounts of d- and l-amphetamine):

Adderall®

Benzedrine®

Biphetamine®

Dexedrine®

Durophet®

Obetrol®

 

The following prescription medication contains d-methamphetamine:

Desoxyn® (Gradumet®)

 

The following substances are known to metabolize to methamphetamine (and amphetamine):

Benzphetamine (Didrex®)

Dimethylamphetamine

Famprofazone

Fencamine

Furfenorex

Selegiline (Deprenyl, Eldepryl®)

 

The following substances are known to metabolize to amphetamine:

Amphetaminil

Clobenzorex (Dinintel®, Finedal®)

Ethylamphetamine

Fenethylline (Captagon®)

Fenproporex (Tegisec®)

Mefenorex (Pondinil®)

Mesocarb

Prenylamine

 

Note: These lists are not all inclusive.

 

Note: The suffix "amine" implies the drug contains an amine structure; however, not all amines contain or are metabolized to methamphetamine and/or amphetamine.

 

 

3. Interpreting Laboratory Result

 

The donor provides the following response:

 

a. Claims to have been taking a prescription medication.

 

1. The MRO requests the donor to provide a copy of the prescription or the sample bottle with the appropriately labeled prescription.

 

Note: The prescription should be for one of the drugs listed above that contains either amphetamine, methamphetamine, or a substance that can metabolize to amphetamine or methamphetamine. If the prescription does not satisfy this requirement, the drug in the prescription provided by the donor is not a valid medical explanation for the positive amphetamine result and the "POSITIVE" laboratory result is verified as a "POSITIVE" to the employer.

 

Note: If the donor had completed taking the prescribed medication by the time he or she is contacted, the donor may no longer have the prescription bottle. When this occurs, the donor must provide a copy of the medical record that documents the valid medical use of the drug during the time of the drug test. There may be a need to contact the prescribing physician or the pharmacist who filled the prescription to verify the information provided by the donor.

 

 

Note: If a donor has been taking a prescription medication that contains methamphetamine or amphetamine for a long time, there should be appropriate justification for their long term use because of the high potential for abuse. The MRO should contact the prescribing physician to express concern that the continued use of the medication may present a significant safety problem for the donor while on the medication.

 

Note: Selegiline is a brain monoamine oxidase inhibitor used in the adjunctive treatment of Parkinsonís disease and for depression. Selegiline is metabolized to l-methamphetamine and l-amphetamine. A d- and l- isomer differentiation will reveal the presence of only l-methamphetamine and l-amphetamine after the ingestion of Selegiline.

 

 

2. If this alternative medical explanation is substantiated for a specimen containing d-methamphetamine or d-amphetamine or the specimen contains only l-methamphetamine/l-amphetamine, the MRO must verify and report the result as a "NEGATIVE."

 

b. Claims to have used a Vicks Inhaler®.

 

1. Since the Vicks Inhaler® contains l-methamphetamine, there is a possibility that a laboratory positive result could be reported for l-methamphetamine and/or l-amphetamine.

 

2. The MRO should request the laboratory to perform a d-, l- isomer differentiation.

 

Note: Although one would expect to see 100% l-methamphetamine following Vicks Inhaler® use, there may be a trace amount of d- isomer present because a very slight amount of d-methamphetamine may be present as a contaminant in the Vicks Inhaler®.

 

3. After the laboratory conducts the isomer differentiation, if there is greater than 80% l-methamphetamine, the results are considered to be consistent with Vicks Inhaler® use and the result is verified as a "NEGATIVE."

 

Note: This is a very conservative interpretation.

 

4. If there is more than 20% d-methamphetamine present, the results indicate the use of some source other than the inhaler and the result is verified as a "POSITIVE."

 

 

c. Claims to have used other over-the-counter medications.

 

1. The MRO would verify the laboratory result as a "POSITIVE."

Note: There are no over-the-counter medications, other than the Vicks Inhaler®, that contain either d- or l- methamphetamine or amphetamine. Although we know that some sympathomimetic amines can test positive on an immunoassay test, they will not be reported positive by the laboratory after conducting the confirmatory test; the confirmatory GC/MS test is specific for methamphetamine and amphetamine.

 

The NLCP requires that for the laboratory to report a specimen "POSITIVE" for methamphetamine only (i.e., above the confirmatory test level of 500 ng/mL) the specimen must also contain amphetamine (which is a metabolite of methamphetamine) at a concentration equal to or greater than 200 ng/mL. If this criterion is not met, the specimen must be reported negative for amphetamines. (This additional requirement was established in response to identifying methamphetamine in urine specimens containing between 500,000 and 1,500,000 ng/mL pseudoephedrine/ephedrine. This was an analytical phenomenon resulting from the chemical similarity of pseudoephedrine/ephedrine to methamphetamine (i.e., pseudoephedrine/ephedrine shares the same chemical structure as methamphetamine with an a-OH group) and the extremely harsh physical conditions that exist in the GC/MS process. During the GC/MS process, the pseudoephedrine/ephedrine was changed into methamphetamine through physical loss of the a-OH group. Since amphetamine was not formed during this process, incorporation of this 200 ng/mL amphetamine reporting rule is a safeguard for the reporting of "methamphetamine only" results that may have resulted from a donor taking very large quantities of over-the-counter sympathomimetic amines. An amphetamine result will not be reported as "POSITIVE" by the laboratory unless its concentration exceeds the 500 ng/mL confirmatory test level. In the case of a report stating only a methamphetamine positive, the MRO may contact the laboratory to verbally confirm that amphetamine was present between 200 and 500 ng/mL.

 

d. Admits or denies using any substance illegally and has no other explanation.

 

1. The MRO verifies the result as a "POSITIVE" for amphetamine and/or methamphetamine.

 

 

 

B. Cocaine

 

1. Background

 

Cocaine is an alkaloid from the coca plant, Erythroxylon coca. It usually is obtained as cocaine HCl, but those who smoke the drug prepare the "freebase" or "crack" form, chemically removing the HCl. This form better survives the high temperatures involved in smoking. Cocaine is widely used in the United States.

 

Cocaine produces psychomotor and autonomic stimulation with a euphoric subjective "high." Larger doses may induce mental confusion or paranoid delusions, and serious overdoses cause seizures, respiratory depression, cardiac arrhythmias, and death.

 

Cocaine abusers, even if they do not use the drug at work, often report vocational impairment due to exhaustion; they use the drug until late at night. Among chronic users, exhaustion, lethargy, and mental depression appear, and the stimulant effect may seem progressively weaker. But the drug is highly reinforcing; repeated experiences with it tend to drive further episodes of self-administration. After repeated exposures, many patients say that although the drug no longer produces much of a "high," they are unable to abstain.

 

Short-term tolerance (tachyphylaxis) develops when several doses of cocaine are administered over a brief period. Reports of weaker "highs" with repeated use also suggest tolerance. However, animal studies show "reverse tolerance," with certain behavioral effects becoming stronger upon repeated administration. So the question of tolerance to cocaine remains an area for further research. Patients withdrawing from cocaine experience moderate lethargy and drowsiness, severe headaches, hyperphagia, vivid dreams, and some mental depression. These symptoms usually abate within a few days to a few weeks.

 

Cocaine usually is taken by one of three routes: intranasal "snorting" is the most common; its "freebase" or "crack" form of the drug is smoked, utilizing the pulmonary route; and intravenous injections.

 

 

2. Metabolism and Excretion

 

Cocaine is rapidly and extensively metabolized by liver and plasma enzymes. The major metabolite, benzoylecgonine, is more persistent; it usually is detected for 2 days after a single dose. Cocaine and benzoylecgonine are not significantly stored in the body; therefore, even after heavy, chronic use urine specimens will be negative when collected a few days after last use.

 

 

3. Interpreting Laboratory Result

 

The donor provides the following response:

 

a. Claims to have used a prescription medication or was given cocaine during a medical or dental procedure.

 

Note: There are no prescription medications that contain cocaine. However, the medical community uses TAC (tetracaine, adrenalin, cocaine) as a topical preparation prior to various surgical procedures and may use cocaine by itself as a topical vasoconstrictive anesthetic for various ear, nose, throat, and bronchoscopy procedures. If cocaine is used, the licensed physician performing the procedure would document its use in the donorís medical record. Cocaine is structurally unique and does not resemble any of the other topical anesthetics, such as Novocain®, Xylocaine® (lidocaine), benzocaine, etc. Although these compounds have analgesic properties, there is no structural similarity to cocaine or its metabolite (benzoylecgonine).

 

1. Request the donor to provide a copy of the medical record that documents the recent use of cocaine as a topical anesthetic.

 

2. If this alternative medical explanation is substantiated, the MRO must verify and report the result as a "NEGATIVE."

 

Note: Keep in mind that the medical use must have occurred within 2 to 3 days prior to when the urine specimen was collected. Use at an earlier time will not cause a positive urine test.

 

b. Claims passive inhalation of crack cocaine.

 

1. Allow the donor to describe the circumstances pertaining to how and when the passive exposure occurred.

2. Passive inhalation is not an alternative medical explanation for the presence of benzoylecgonine in the donorís urine.

 

Note: A comprehensive study conducted at NIDAís Addiction Research Center (E.J. Cone, D. Yousefnejad, M.J. Hillsgrove, B. Holicky, and W.D. Darwin. Passive Inhalation of Cocaine. J.Anal.Toxicol. 19:399-411(1995)) has demonstrated that individuals passively exposed to "crack" smoke did not produce a urine positive for cocaine using the established testing levels.

 

3. MRO verifies and reports the result as a "POSITIVE."

 

 

c. Claims to be ingesting "Health Inca Tea."

 

Note: In the early 1980s, health food stores were selling a tea under the tradename "Health Inca Tea." When it was discovered that this tea contained decocanized coca leaves with detectable amounts of cocaine present, the U. S. Food and Drug Administration banned the importation of any tea containing residual cocaine into the United States. Therefore, any tea being sold using the name "Health Inca Tea" should not contain any cocaine.

 

1. Allow the donor to explain where and when the tea was purchased.

 

2. Drinking "Health Inca Tea" is not an alternative medical explanation for the presence of benzoylecgonine in the donorís urine.

 

3. MRO verifies and reports the result as a "POSITIVE."

 

d. Admits or denies using cocaine and has no other explanation.

 

1. The MRO verifies the result as a "POSITIVE" for cocaine.

 

 

 

C. Marijuana

 

1. Background

 

Marijuana comes from the hemp plant, Cannabis sativa. The principal psychoactive agent in marijuana is delta-9-tetrahydrocannabinol (THC).

 

Marijuana produces a pleasant euphoria or "high," commonly followed by drowsiness. Intoxication temporarily impairs concentration, learning, and perceptual-motor skills. Thus, for at least 4-6 hours after a dose of marijuana, employees probably function with reduced abilities. Preliminary studies suggest that performance is impaired long after the acute subjective effects have ended. Experienced pilots in a flight simulator were impaired for at least 24 hours after a dose, long after the subjective "high" had disappeared. Functional impairments are less well understood in cases of prolonged, heavy marijuana use, because although THC accumulates in the body, behavioral and physiological tolerance also develops.

 

In addition to tolerance, a mild abstinence syndrome may follow abrupt termination of very high-dose, chronic marijuana use. Withdrawal signs include irritability, sleep disturbance, diminished appetite, gastrointestinal distress, salivation, sweating, and tremors. Marijuana abstinence syndromes are uncommon at the doses at which the drug is usually taken in this country.

 

 

2. Metabolism and Excretion

 

Marijuana is usually smoked; transpulmonary absorption rapidly gets psychoactive drugs to the brain. Since the drug also is absorbed from the gastrointestinal tract, although much more slowly, marijuana sometimes is eaten. THC leaves the bloodstream and is distributed into different parts of the body where it is metabolized, excreted, or stored. The THC that is stored in fatty tissue gradually reenters the blood stream at very low levels, permitting metabolism and eventual excretion. THC is metabolized extensively in the liver and the major metabolite is 11-nor-D9-tetrahydrocannabinol-9-carboxylic acid (delta-9 THCA).

 

The immunoassay procedures detect multiple metabolites of marijuana, while the GC/MS procedure specifically identifies and quantitates the delta-9 THCA metabolite. To be reported positive, a specimen must screen positive at or above the 50 ng/mL cutoff and have a concentration of the delta-9 THCA that is equal to or greater than the 15 ng/mL confirmatory cutoff level. Considering these cutoffs, a person with no marijuana experience who smokes a single marijuana cigarette may be positive for 1-3 days. But with repeated smoking, THC accumulates in fatty tissue; so frequent, chronic smokers slowly release THC over a longer time and may continue to produce detectable levels below the cutoff values for longer periods of time (depending upon the assay cutoff).

 

3. Interpreting Laboratory Result

 

The donor provides the following response:

 

a. Claims to have used a prescription or over-the-counter medication.

 

Note: Dronabinol is chemically synthesized delta-9- tetrahydrocannabinol (THC). It is available under the trade name Marinol® in 2.5, 5, or 10 mg soft gelatin capsules for oral administration. Marinol® may be used for stimulating appetite and preventing weight loss in patients with a confirmed diagnosis of AIDS and treating nausea and vomiting associated with cancer chemotherapy. Additionally, a few individuals have been permitted by a court order to use THC for the management of glaucoma. Patients that are prescribed Marinol® should be warned not to drive, operate complex machinery, or engage in hazardous activity.

Note: There are no other prescription or over-the-counter medications that contain cannabinoids or any other substances that might be identified as or metabolized to THC or its acid metabolite.

 

1. Request the donor to provide a copy of the medical record or court order that would document the legal use of Marinol® or marijuana.

 

2. If this alternative medical explanation is substantiated, the MRO must verify and report the result as a "NEGATIVE."

 

b. Claims passive inhalation or unknowing ingestion.

 

Note: Passive inhalation, unknowing ingestion (i.e., an inadvertent exposure to marijuana), or eating hemp seeds is frequently claimed as the basis for a positive urine test. Passive inhalation of marijuana smoke does occur and can result in detectable levels of THC and its metabolites in urine. Clinical studies have shown, however, that it is highly unlikely that a nonsmoking individual could unknowingly inhale sufficient smoke by passive inhalation to result in a high enough drug concentration in urine for detection at the cutoff levels used in the Federal program. Similarly, it is extremely difficult to achieve detectable levels through unknowing ingestion of hemp plant material (such as, leaves, stems) or eating food products containing hemp seeds. The studies also show that any measurable peak concentration in urine occurs within several hours after the exposure.

 

1. Allow the donor to describe the circumstances pertaining to how and when the passive exposure, unknowing ingestion, or eating hemp seeds occurred.

 

Note: These reasons do not constitute an alternative medical explanation.

 

2. MRO verifies and reports the result as a "POSITIVE."

 

c. Admits or denies using marijuana but has no other explanation.

 

1. The MRO verifies the result as a "POSITIVE" for cannabinoids.

 

 

D. Opiates

 

1. Background

 

Opioids are a large class of analgesic drugs, the effects of which are stereospecifically antagonized by naloxone. Opiates refer to natural products derived from the juice of the opium poppy (loosely applied to morphine derivatives). The opium poppy flower is the source of the natural opiate prototype alkaloid, morphine. The opium poppy is also the source of the naturally occurring alkaloid codeine; codeine is also synthesized chemically for inclusion in medications available through prescription and over-the-counter. Heroin (or diacetylmorphine) is a semisynthetic opiate obtained by reacting natural morphine with acetic acid. Heroin has no legitimate medical uses in the United States and is only available illegally (DEA Schedule I).

 

Opioid intoxication may cause miosis, a dull facies, confusion or mental dullness, slurring of speech, drowsiness, partial ptosis, or "nodding" (the head drooping toward the chest and then bobbing up).

 

Tolerance develops to opioid effects, and abusers escalate doses when possible. Physical dependence results in a moderate, nonlethal, "flu"-like abstinence syndrome with nausea, diarrhea, coryza, occasional vomiting, weakness, malaise, "gooseflesh," and mydriasis. Also flu-like symptoms are common during opiate withdrawal, e.g., watery eyes, nausea and vomiting, muscle cramps, and loss of appetite. All opiates are physically and psychologically addictive, and produce withdrawal symptoms that differ in type and severity.

 

Heroin and morphine are usually injected, but may be smoked as opium once was, or "snorted" (insufflated) onto the nasal mucosa.

 

Cognitive and psychomotor performance can be impaired by opiates, although the duration and extent of impairment depend on the type of opiate, the dose, and the experience and drug history of the user. Ingestion of low to moderate amounts produces a short-lived feeling of euphoria followed by a state of physical and mental relaxation that persists for several hours.

 

The following prescription medications contain morphine:

Astramorph PF®

Duramorph®

MSIR®

MS Contin Tablets®

Roxanol®

 

The following prescription medications contain codeine:

Actifed with Codeine Cough Syrup®

Codimal PH® Syrup

Dimetane-DC Cough Syrup®

Emprin with Codeine®

Fiorinal with Codeine®

Phenaphen with Codeine®

Robitussin A-C®

Triaminic Expectorant with Codeine®

Tussar-2®

Tylenol with Codeine(#1, 2, 3, or 4)®

 

Note: The above lists are only a representative sample of the prescription medications that contain codeine or morphine.

 

The following nonprescription products contain opium (i.e., morphine):

Amogel PG®

Diabismul®

Donnagel-PG®

Infantol Pink®

Kaodene with Paregoric®

Paregoric

Quiagel PG®

 

The following nonprescription product contains codeine:

Kaodene with Codeine®

 

Note: Each listed nonprescription product is used as an antidiarrheal. They are generally availably over-the-counter; however, nonprescription sale is prohibited in some states. Paregoric alone is a Schedule III prescription drug, but in combination with other substances is a Schedule V over-the-counter product.

 

The following substances metabolize to morphine:

Codeine

Heroin

 

2. Metabolism and Excretion

 

Heroin (diacetylmorphine) is rapidly deacetylated to 6-acetylmorphine (6-AM; also called 6-monoacetylmorphine, 6-MAM), and, therefore, heroin itself is rarely ever detected in the urine. Heroin's characteristic metabolite, 6-AM, is rapidly deacetylated to morphine, and will likely not be detected in most urine specimens of heroin users. Since codeine is a naturally occurring alkaloid in the same opium poppy juice that is the source of morphine used as the starting material for heroin synthesis, codeine may be found in the urine of heroin users.

 

Morphine is rapidly absorbed and excreted as unchanged morphine and as conjugated glucuronides (i.e., morphine-3-glucuronide, morphine-6-glucuronide). The primary metabolite is morphine-3-glucuronide. Morphine and its metabolites can be detected in urine up to about 4 days after its use.

 

Codeine (methylmorphine) is also rapidly absorbed and is excreted as unchanged codeine, morphine, and glucuronide conjugates.

 

Since the body metabolizes codeine to morphine, both substances (i.e., codeine and morphine) may occur in the urine following the use of codeine. Recently ingested codeine explains the presence of both drugs in the urine specimen (i.e., parent drug codeine and morphine metabolite). After the ingestion of a legitimate medical preparation containing codeine, there comes a time when parent codeine has been completely excreted or metabolized to morphine, so that morphine only is detected in the urine.

 

Ingestion of morphine in any form will never account for the presence of codeine in the urine (codeine is not a metabolite of morphine).

 

Note: There are a number of synthetic or semisynthetic analgesics available including, but not limited to, alphaprodine (Nisentil®), hydromorphone (Dilaudid®), oxymorphone (Numorphan®), hydrocodone (Hycodan®), dihydrocodeine (Paracodin®), oxycodone (Percodan®), propoxyphene (Darvon®), methadone (Dolophine®), meperidine (Demerol®), fentanyl (Sublimaze®), pentazocine (Talwin®), and buprenorphine (Buprenex®). These drugs do not metabolize to either codeine, morphine, or 6-acetylmorphine. When a donor presents a prescription for a narcotic analgesic, the MRO should verify that it does not contain codeine or morphine and, therefore, cannot metabolize to codeine, morphine, or 6-acetylmorphine.

 

3. Interpreting Laboratory Result

 

The opiate drug class poses some unique challenges with regard to interpreting a positive test result. A positive for codeine or morphine may be a result of a donor having taken a prescription medication that contains codeine or morphine or a donor consuming normal dietary amounts of poppy seeds. In addition, for the opiate drug class, there is a requirement to document clinical evidence of illegal use.

Note: The Mandatory Guidelines state that "Before the MRO verifies a confirmed positive result for opiates, he or she shall determine that there is clinical evidence - in addition to the urine test - of illegal use of any opium, opiate, or opium derivative. . . ." The main issue is the MRO must substantiate that there is "clinical evidence of illegal use" of an opiate substance before a positive result reported by a laboratory can be verified as a "POSITIVE." Clinical evidence of illegal use may include, but is not limited to: a donor admits using heroin or admits taking a prescription medication containing codeine or morphine that was prescribed to another individual; recent needle marks; or behavioral and psychological signs of acute opiate intoxication or withdrawal. If "clinical evidence of illegal use" is not present, the MRO must verify the "POSITIVE" result reported by the laboratory as a "NEGATIVE" result to the employer.

 

Note: The 6-acetylmorphine metabolite comes only from heroin; therefore, its presence confirms the illegal use of heroin. When the presence of 6-AM is confirmed, there is no requirement for clinical evidence.

 

Note: To ensure that an MRO has the information necessary to review and interpret a positive morphine or codeine test result, the Guidelines permit an MRO to have a blanket written request on file at the laboratory to routinely receive the quantitative values associated with a positive codeine and morphine result. In addition, the MRO may request quantitative information on the presence of codeine below the cutoff for specimens which have been reported positive for morphine only. This information may be helpful to the MRO in assessing the medical explanation provided by the donor.

 

Note: Quantitative test results may not be requested by the MRO from the testing laboratory on a routine basis for the other drug categories, but may be requested on a case-by-case basis.

 

The donor provides the following response:

 

a. Admits taking morphine or codeine illegally or using heroin.

 

1. The MRO verifies the result as a "POSITIVE" for the drug reported by the laboratory.

 

 

b. Claims to have taken a prescription medication.

 

1. The MRO requests the donor to provide a copy of the prescription or the medication with the appropriately labeled prescription.

 

Note: The MRO must verify as "NEGATIVE" any codeine or morphine test result for which the donor has taken a legally prescribed codeine or morphine medication.

 

Note: Occasionally, a donor will reveal information regarding the use of a narcotic analgesic (that does not contain codeine or morphine) believing that this medication was the reason for the positive codeine or morphine. Assuming that it was a legally prescribed medication, this confidential medical information cannot be provided to the employer and is not an explanation for the positive codeine or morphine. Since the use of a narcotic analgesic may have a possible effect on the ability of the donor to perform a specific task (such as, driving a vehicle), it may be appropriate to discuss the use of the medication with the prescribing physician. See Section G in Chapter 4 regarding the reporting of this information to the employer.

 

c. Claims to have eaten foods that contain poppy seeds.

 

Note: One reason for the requirement for clinical evidence of abuse or illegal use in opiate testing is that eating a normal dietary amount of poppy seeds can cause a urine specimen to test positive for morphine and codeine (i.e., they contain trace amounts of morphine with or without codeine). In many instances, a donor will not know that poppy seeds can cause a positive test or that he or she had eaten poppy seeds at the time the urine was collected. The concentration of morphine can be substantial, with usually very low concentrations or no detectable codeine. Unless clinical evidence of abuse or illegal use of opiates is verified, the MRO must verify and report the result as a "NEGATIVE."

 

 

E. Phencyclidine

 

1. Background

 

Phencyclidine (PCP), an arylcyclohexylamine, was first synthesized in the 1950's as a general anesthetic. Street names include Angel Dust, Crystal, Killer Weed, Supergrass, and Rocket Fuel. PCP's synthesis is relatively simple for clandestine laboratories. Phencyclidine's use as a human anesthetic was discontinued because it produced psychotic reactions ("emergence delirium"), and its more prolonged use as a veterinary tranquilizing agent also has stopped. PCP is currently a DEA Schedule II controlled substance, has no current therapeutic role, and all uses are illegal. The preferred route of ingestion is smoking, but it may be eaten, snorted, or injected intravenously.

 

PCP is best classified as a hallucinogen and has a variety of effects on the central nervous system. Intoxication begins several minutes after ingestion and usually lasts eight hours or more. PCP is well known for producing unpredictable side effects, such as psychosis or fits of agitation and excitability. PCP clearly has drastic effects on performance. Clinical cases have documented the severe debilitating physical and psychological effects of PCP abuse and the extremely unpredictable behavior caused by the drug.

 

Intoxication may result in persistent horizontal nystagmus, blurred vision, diminished sensation, ataxia, hyperreflexia, clonus, tremor, muscular rigidity, muteness, confusion, anxious amnesia, distortion of body image, depersonalization, thought disorder, auditory hallucinations, and variable motor depression or stimulation, which may include aggressive or bizarre behavior.

 

2. Metabolism and Excretion

 

PCP is well absorbed by any route and is excreted as unchanged PCP and as conjugates of hydroxylated PCP. About 10 percent of the PCP dose is excreted in the urine as the parent compound. PCP is a weak base which concentrates in acidic solutions in the body. Because of gastric acidity, PCP repeatedly reenters the stomach from plasma, later returning into plasma from the basic medium of the intestine.

 

Generally, PCP is considered detectable in urine for several days to several weeks depending on the frequency of use.

 

 

3. Interpreting Laboratory Result

 

The donor provides the following response:

 

a. Admits or denies using PCP.

 

1. The MRO verifies the result as "POSITIVE" for PCP.

 

b. Claims to have taken a prescription or over-the-counter medication.

 

1. The MRO verifies the result as "POSITIVE" for PCP.

 

Note: There are no prescription or over-the-counter medications that contain PCP or legal medical uses of PCP.

Chapter 6. Specimen Issues

 

 

A. Specimen Integrity

 

Note: The integrity of each specimen must be a primary concern for each collector during the collection procedure. A collector must make every effort at the time of collection to minimize the opportunity that a donor may have to tamper with the urine specimen before it is transferred to the collector. Although the MRO is not responsible for collecting the specimen, the MRO must be aware of the different attempts a donor may make to avoid a positive drug test and how to interpret the information provided by the collector and the laboratory regarding the integrity of the specimen.

 

During the collection procedure, a donor may attempt to adulterate, dilute, or substitute the specimen that he or she gives the collector. In most cases, the collector should be able to identify when a potential problem exists and take immediate action to correct it (e.g., the specimen is clearly adulterated and the collector gets permission to conduct a second collection using direct observation). If the collector does not suspect that there is a problem with the donorís specimen but the donor was able to tamper with the specimen, the problem with the specimen may be identified by the laboratory during the testing. When this occurs, the laboratory will provide an appropriate comment on the "REMARKS" line in Step 7 on the CCF.

 

 

B. Substitution

 

Substitution refers to a donorís attempt to replace his or her urine specimen with "clean" urine, synthetic urine, water, or other fluid during the collection procedure. Generally, it is difficult for a donor to substitute an entire urine specimen and ensure that the substituted specimen is within the required temperature range. If the specimen temperature is not within the acceptable range, the collector knows that substitution may have occurred. The collector must provide an appropriate comment on the CCF, and the collector will normally be given permission to collect a second specimen using direct observation. Although the substituted specimen will be submitted to the laboratory for testing, the laboratory results will probably indicate that it did not appear to be a valid urine specimen.

 

Note: In addition to annotating the CCF for the first specimen collected, the collector should have provided an appropriate comment on the "REMARKS" line in Step 5 on the CCF for the second specimen to indicate that the second specimen was collected using direct observation. This comment will alert the laboratory and the MRO to the fact that a problem occurred with the collection of the donorís first specimen.

 

C. Adulteration/Dilution

 

A donor may attempt to adulterate/dilute a specimen either in vivo (i.e., the donor intentionally ingests a substance in an attempt to affect the drug test) or in vitro (i.e., the donor externally adds something to the specimen in an attempt to affect the drug test).

 

Common approaches used to adulterate/dilute a specimen include:

 

1. Ingesting large quantities of fluids (such as, water) or taking diuretics prior to the test in an attempt to reduce (i.e., by internal dilution) any drug concentration to a level which is below the cutoff level for that drug.

2. Adding a small amount of water to the specimen (i.e., external dilution) before handing it to the collector in an attempt to reduce any drug concentration (i.e., by external dilution) to a level which is below the cutoff level for that drug.

 

3. Adding various chemicals and household products (e.g., salt, bleach, lye, soap, gluteraldehyde) to the urine specimen in an attempt to cause a negative drug test result.

 

Note: All of these approaches may be attempted by a donor who believes that his or her urine specimen may be tested positive. To prevent these attempts, it is extremely important that an employer minimizes the notice given to an individual regarding the drug test (i.e., the time allowed to report to the collection site), and that the collector follows the collection procedure and remains alert to any behavior by the donor that might suggest an attempt to subvert the test.

Chapter 7. MRO Documentation and Recordkeeping

 

A. Recordkeeping

 

Accurate recordkeeping is essential in documenting all aspects of the MRO review process. All communications, written or oral (including, but not limited to, those with donors, employer representatives, laboratory personnel, and collectors) must be appropriately documented.

 

Although the Guidelines do not specify the length of time that MROs should retain these records, it is recommended that they be maintained for a minimum of two years from the date of collection, or as otherwise provided by law or contract with the employer.

 

Note: This two-year recommendation agrees with the requirement that each laboratory must retain records associated with the testing of a specimen for a minimum of 2 years.

 

No regulatory requirements exist requiring MROs to use a specific procedure to review drug tests; however, using a standard procedure is likely to ensure that each MRO review is complete and thorough. The use of a simple checklist will ensure that certain activities are always documented.

 

Documentation should normally include such things as copies of prescriptions or labels on prescription bottles, or notes that a prescription was verified at a pharmacy or by the treating physician. Any letters or notes received from an employee, relative, or physician providing treatment should be retained in the file.

 

Finally, MRO records must be separated from other medical and personnel records kept on an individual. For example, some physicians may also serve as a primary care provider and retain medical records related to that function.

 

B. Confidentiality

The Mandatory Guidelines state (paragraph 2.6(h)):

 

The MRO shall report the final results of the drug tests in writing and in a manner designed to ensure confidentiality of the information.

 

The MRO must provide a final verified urine test result to the employer and may be required to provide such results to other agencies by regulation or law. However, the MRO has a responsibility to maintain confidentiality of the information received during the review process including information related to the donor's medical condition, medications, medical diagnosis, and medical history. This role is particularly important with respect to laboratory positive urine drug test results, especially those that may be verified by the MRO as negative due to an alternative legitimate medical explanation. The MRO must also maintain the confidentiality of certain information associated with the testing process, such as quantitative test results, except that the MRO may reveal the quantitation of a positive test result to the employer or the decision maker in a lawsuit, grievance, or other proceeding initiated by or on behalf of the donor resulting from a verified positive drug test.

Despite this general requirement to maintain the confidentiality of medical information, there are certain circumstances in which the MRO may provide such information to other parties. In these instances, the MRO should inform the donor, prior to the medical interview, that disclosure of information learned as part of the medical review process may occur if, in the judgment of the MRO, the information suggests there is a significant safety hazard associated with the information or there is a medical disqualification of the donor under an applicable regulation.

 

Note: Such information may also be released under other circumstances specified by Federal agency regulations.

 

Even when the MRO releases otherwise confidential information due to such concerns, the MRO should attempt to release as little specific information as possible and release such information only to parties with a clear need-to-know. Such parties include physicians responsible for medical certification of the donor, Federal agency officials as required by regulation, or designated employer representatives.

 

Diagnoses or other specific details of medical information do not need to be provided to non-medical personnel. For example, employer representatives may only need to be informed that a safety hazard may exist and that the MRO needs to provide specific information to the physician responsible for making medical qualification decisions regarding the donor. In general, unless required by regulation or law, the MRO should only discuss specific medical information with other physicians or qualified health professionals.

 

Note: A donor has the right, upon written request, to any records relating to his or her drug test. In addition, information can be requested by a subpoena or court order. If an MRO has any concern regarding the release of information associated with drug testing results, the MRO may want to obtain a legal opinion.

Chapter 8. Additional MRO Responsibilities

 

A. Blind Quality Control Samples

 

The Mandatory Guidelines require each Federal agency to ensure that a minimum of 3 percent blind quality control samples are submitted with the donor specimens.

 

Note: Blind quality control samples are helpful in determining if the entire testing process (i.e., from the collection of the specimen until a result is reported by the MRO) satisfies all requirements.

 

The blind quality control samples must be certified by immunoassay and GC/MS and have stability data which verifies their performance over time. The requirement to have certification data ensures that the blind quality control samples purchased from different sources are acceptable.

 

Generally, the employer will request the collector to purchase the blind samples or may provide them to the collector. In either case, the collector must submit each quality control sample as if it were a donor specimen. This requires completing a CCF and properly labeling a specimen bottle. Since there is no donor associated with a quality control sample, the collector must generate a fictitious social security number or employee identification number and fictitious initials to be written on the specimen bottle label/seal. The collector must complete the CCF as for any other specimen, with the exception of Copy 4 of the CCF (i.e., the MRO copy). The collector should indicate that the specimen is a "Quality Control Sample" where a donor would normally print his or her name.

 

In addition, the collector or the employer, whichever purchased the blind samples, should forward that information to the MRO. This will allow the MRO to determine if the laboratory reported the correct result when the Copy 2 of the CCF is received from the laboratory.

 

Note: An incorrect result reported by the laboratory does not automatically indicate that the laboratory made an analytical error. For example, there could have been a problem with the stability and/or concentration of the quality control sample or the collector did not properly submit the sample.

 

If the laboratory reports a result different from the one expected based on information provided by the manufacturer of the blind sample, the MRO should contact the laboratory to determine if there is an obvious reason why the laboratory did not report the expected result. If there is no obvious reason, the MRO may request the laboratory to retest the specimen or to have an aliquot sent to another certified laboratory for confirmatory testing. If the retest result confirms the original result reported by the laboratory, it is most likely that an error occurred at the collection site or there was a problem with the quality control sample as purchased. If the retest result does not confirm the original result, the laboratory likely made an error.

 

Note: A false negative result (i.e., the laboratory reports a negative on a blind sample when a positive result was expected) is a concern, but should not be considered serious unless it occurs frequently and the MRO would not be expected to request the laboratory to retest the blind sample. However, a false positive (i.e., the laboratory reports a positive on a blind sample when a negative result is expected) is serious and must be investigated.

 

If the retest result has confirmed that a false positive was reported by the laboratory on a blind quality control sample, the MRO should contact the employer. The employer should then contact the appropriate regulatory office who will conduct an investigation in an attempt to determine the exact cause of the false positive. When the specific cause is identified, the laboratory will be required to take corrective action to prevent the recurrence of the error. The regulatory office will share the findings with the employer and the MRO.

 

B. Shy Bladder

 

Occasionally, a donor is unable to provide a specimen upon arrival at the collection site because he or she either urinated recently or has a "shy bladder." Generally, the term "shy bladder" refers to an individual who is unable to provide a sufficient specimen either upon demand or when someone is nearby during the attempted urination.

 

If it is believed that an individual has a "shy bladder," the employer should arrange to have the donor evaluated, as soon as practical after the attempted collection, by a licensed physician (e.g., a physician acceptable to the employer, the employerís occupational health physician) to determine whether the donorís inability to provide a specimen is genuine or constitutes a refusal to provide a specimen.

 

Note: The examining physician shall determine, in his or her reasonable medical judgment, that a medical condition has or, with a high degree of probability, could have precluded the employee from providing an adequate amount of urine (e.g., a urinary system dysfunction or a documented preexisting psychological disorder). An evaluation should include a review of any pertinent medical records and may include evaluative testing such as blood chemistries for kidney function or other physiologic factors likely to affect urine output.

 

Note: Unsupported assertions of "situational anxiety" or dehydration are not considered valid reasons for a donorís failure to provide an adequate amount of urine when sufficient time has elapsed and fluid volume has been ingested and shall be regarded as a refusal to take a test.

 

The examining physician shall provide to the MRO a brief written statement describing his or her conclusion and the basis for it. The written statement shall not include detailed information on the medical condition of the donor. Upon receipt of the written statement from the examining physician, the MRO shall report his or her conclusions to the employer in writing.

 

C. Testing for Additional Drugs

 

HHS currently certifies laboratories to test only for five drug classes (i.e., cannabinoids, cocaine, opiates, phencyclidine, and amphetamines); however, there may be instances when testing for another drug listed in Schedule I or II of the Controlled Substances Act (e.g., reasonable suspicion/cause, post accident) is justified. Additionally, a Federal agency may be granted a waiver by the Secretary of the Department of Health and Human Services to routinely test for another specific drug or drug class.

Note: As of this time, a waiver has never been granted to a Federal agency by the Secretary of HHS to routinely test for another drug or drug class.

 

For any circumstance where testing for an additional drug is justified, the collector marks the "OTHER" box in Step 1 on the CCF and specifies the name of the drug(s) to be tested.

 

Note: There should also be a memorandum from the Federal agency explaining why the specimen is being tested for this additional drug. Otherwise, the laboratory should not test for that additional drug.

 

Since the MRO will possibly be reviewing a test result that is not a normal part of the Federal Workplace Drug Testing Program, the MRO should obtain a full documentation package from the laboratory. As described in Chapter 4, the full documentation package should contain all the information needed to assess the analytical test result. In addition, the MRO should contact the laboratory to discuss the testing that was conducted for the additional drug(s) to ensure that the laboratory used procedures and quality control safeguards which were comparable to those used for testing the five drug classes in the certification program.

 

Note: Since laboratories are not certified to perform the testing for additional drugs, the MRO should become familiar with issues related to the validity and reliability of such test results. In serving as the MRO for an agency that authorized the testing for an additional drug(s), the MRO does have the responsibility to review the scientific sufficiency of urine drug test results as part of the medical review process.

Appendix A. National Laboratory Certification Program

 

A. Background

 

Note: This is only a brief summary of the laboratory certification program; a detailed description is provided in the HHS Mandatory Guidelines.

 

The Department of Health and Human Services established the National Laboratory Certification Program (NLCP) to certify laboratories before they are permitted to test specimens that are collected for Federal agency drug testing programs. In addition, the Department of Transportation, the Department of Energy, and the Nuclear Regulatory Commission also require the industries they regulate to use these certified laboratories for their workplace drug testing programs. The NLCP includes comprehensive performance testing (PT) and laboratory inspection programs. Currently, each laboratory is required to successfully complete an "initial" inspection prior to certification, a "3-month" inspection after certification, and semiannual "maintenance" inspections thereafter. The PT program consists of 3 sets of "initial" PT samples prior to certification and quarterly sets of "maintenance" PT samples thereafter.

 

Note: Laboratories that are HHS-certified under the NLCP to conduct forensic urine drug testing are specifically exempt from the requirements set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA Ď88). However, this exemption is limited to the certified laboratoriesí immunoassay and GC/MS confirmatory testing processes for the five drug classes (HHS-5) stated in the Mandatory Guidelines and related processes that HHS certifies. Certified laboratories that perform tests for the HHS-5 drugs by procedures not in accordance with the Mandatory Guidelines or by methods not certified by HHS are subject to the technical and regulatory requirements of CLIA '88.

 

The Mandatory Guidelines require each laboratory to have a Standard Operating Procedure (SOP) manual which includes, but is not limited to, a complete description of the laboratoryís chain-of-custody procedures, analytical testing procedures, quality control program, equipment and maintenance, accessioning and security, personnel qualifications and training, and reporting procedures. All aspects of a laboratoryís operations are reviewed during each inspection.

 

B. Accessioning/Analytical Test Procedures

 

The first step performed by the laboratory is to accession the specimens. When a shipment of specimens is received, laboratory personnel inspect each package for evidence of possible tampering and compare information on specimen bottles within each package to the information on the accompanying custody and control forms. The specimen bottles are normally retained within the laboratory's secured, limited access accessioning area until all analyses have been completed. Aliquots (i.e., a portion of the specimen) and the laboratoryís internal chain of custody forms are used by laboratory personnel when conducting the initial and confirmatory tests.

 

A laboratory generally processes specimens by grouping them into batches. The number of specimens in each batch varies depending on the size of the laboratory and its workload. When conducting either the initial or confirmatory test, every batch is required to contain an appropriate number of quality control samples (i.e., calibrators, negative urine samples, controls, and blind samples) to ensure the accuracy of test results along with the donor specimens.

 

 

1. The Initial Test

 

Every urine specimen must be analyzed using an initial test (i.e., an immunoassay test) that has been approved for commercial distribution as an in vitro diagnostic test by the Food and Drug Administration (FDA). A number of different immunoassay techniques are available to screen for the five drug classes (e.g., radioimmunoassay (RIA), enzyme immunoassay (EIA), kinetic interaction of microparticles in a solution (KIMS), and fluorescence polarization immunoassay (FPIA)). The initial test is used to eliminate "negative" urine specimens from further consideration and to identify the presumptively positive specimens that require confirmation or further testing. A negative specimen is any specimen which contains no drug or whose apparent concentration of analyte is less than the cutoff concentration for that drug or drug class.

 

Some laboratories may conduct a second initial test prior to GC/MS confirmation in an effort to enhance the specificity of the assay. If the laboratory uses a second initial test to further identify a specimen as positive prior to GC/MS confirmation, the second initial test is subject to the same criteria and HHS Guidelines requirements as the first initial test.

 

Immunoassays use antibodies to detect the presence of a drug or metabolite in urine. Antibodies are proteins that chemically bind with specific substances called antigens (i.e., a drug or drug metabolite). In immunoassay tests, a known amount of an antibody is added to the urine specimen. In addition, a known amount of labeled drug or drug metabolite (antigen) is added to the specimen. Any drug or drug metabolite present in the specimen will competitively compete with the labeled drug or metabolite to bind with the antibodies forming antigen-antibody complexes. The amount of labeled antigen that is able to bind with an antibody is a function of the amount of drug or drug metabolite in the urine. Chemical spectrophotometric endpoints of these reactions are used to semi-quantitatively identify drugs and/or metabolites in each urine specimen.

 

 

2. The Confirmatory Test

 

All specimens identified as positive on the initial test must be confirmed positive using gas chromatography/mass spectrometry (GC/MS) before a positive result can be reported.

 

GC/MS is a combination of two different analytical techniques. Gas chromatography physically separates the various substances that have been extracted from a specimen (such as urine). Mass spectrometry is the technique used to provide a positive identification of substances that were separated by the gas chromatograph. In general, GC/MS analysis involves using a solid phase or solvent-solvent extraction procedure to extract a drug from most other components of a urine specimen, and after the extraction procedure the extract is injected into the GC/MS to perform the final separation, identification, and quantification of the specific drug or drug metabolite present in the urine specimen.

 

C. Reporting Results

 

As specified in the Mandatory Guidelines, the laboratory must report test results to the MRO within an average of 5 working days after the specimen is received by the laboratory. Before any test result is reported, the result must be reviewed and certified by a laboratory Certifying Scientist (CS). The CS completes Step 7 on Copy 1 and Copy 2 of the CCF and sends Copy 2 of the CCF to the MRO.

 

Note: The laboratory will use its own form to report the results for the retesting of a single specimen. If a split specimen was collected and tested, the result for the split specimen will be reported using Copy 3 of the CCF.

 

The laboratory shall report as "NEGATIVE" all specimens which are negative on the initial test or negative on the confirmatory test. Only specimens confirmed positive shall be reported "POSITIVE" for a specific drug.

 

Note: The retesting of a single specimen or the testing of a split specimen is not subject to using the testing levels established for the original testing of a specimen. The laboratory is only required to provide data that is sufficient to confirm the presence of the drug or drug metabolite that was reported present in the original testing of a single specimen or the Bottle A specimen for a split specimen collection.

 

Note: The laboratory may perform an immunoassay analysis on the retest specimen solely to determine a dilution factor in preparation for the GC/MS retest analysis.

 

The laboratory may transmit results to the MRO by various electronic means (e.g., facsimile or computer); however, it must be done in a manner designed to ensure confidentiality of the information. Results may not be provided verbally by telephone. The laboratory must ensure to the best of its ability the security of the data transmission and limit access to any data transmission, storage, and retrieval system.

 

Unless otherwise instructed by the agency in writing, the laboratory must retain all records pertaining to a given urine specimen for a minimum of 2 years. If there is a legal challenge to a test result, a laboratory may be requested to maintain documents for any specimen for an indefinite period of time.

 

The laboratory is required to keep specimens that were reported positive in properly secured limited access long-term frozen storage for a minimum of 1 year. Retaining specimens will ensure their availability for any necessary retesting during administrative or disciplinary proceedings. Within this 1-year period, an employer may request the laboratory to retain the specimen for an additional period of time, but if no such request is received the laboratory may discard the specimen after the end of 1 year.

 

 

Appendix B. Federal Custody and Control Form

 

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

 

 

Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing this burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.

 

 

 

 

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

 

 

Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing this burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.

 

 

 

 

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

 

 

Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing this burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.

 

 

 

 

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

 

 

Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing this burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.

 

 

 

Privacy Act Statement: (For Federal Employees Only)

 

Submission of the information on the attached form is voluntary. However, incomplete submission of the information, refusal to provide a urine specimen, or substitution or adulteration of a specimen may result in delay or denial of your application for employment/appointment or may result in removal from the Federal service or other disciplinary action.

 

The authority for obtaining the urine specimen and identifying information contained herein is Executive Order 12564 ("Drug-Free Federal Workplace"), 5 U.S. C. ß 3301 (2), 5 U.S. C. ß 7301 and Section 503 of Public Law 100-71, 5 U.S.C. ß 7301 note. Under provisions of Executive Order 12564 and U.S.C. 7301, test results may only be disclosed to agency officials on a need-to-know basis. This may include the agency Medical Review Officer, the administrator of the Employee Assistance Program, and a supervisor with authority to take adverse personnel action. This information may also be disclosed to a court where necessary to defend against a challenge to an adverse personnel action.

 

Submission of your SSN is not required by law and is voluntary. Your refusal to furnish your number will not result in the denial of any right, benefit, or privilege provided by law. Your SSN is solicited, pursuant to Executive Order 9397, for purposes of associating information in agency files relating to you and for purposes of identifying the specimen provided for urinalysis testing for illegal drugs. If you refuse to indicate your SSN, a substitute number or other identifier will be assigned, as required, to process the specimen.

 

In the event laboratory analysis determines the presence of one or more illegal drugs in the specimen you provide, you will be contacted by an agency Medical Review Officer (MRO). The MRO will determine whether there is a legitimate medical explanation for the drug(s) identified by urinalysis.

 

 

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

 

Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing this burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.

 

 

 

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

 

 

Public reporting burden for this collection of information, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information is estimated for each respondent to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; and 3 minutes/Medical Review Officer. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing this burden, to the SAMHSA Reports Clearance Officer, Paperwork Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158.

 

 

INSTRUCTIONS FOR COMPLETING DRUG TESTING CUSTODY AND CONTROL FORM

The following instructions are in accordance with procedures established by the Department of Health and Human Services and the Department of Transportation mandatory guidelines for federal and transportation workplace drug testing programs.

NOTE: Use ballpoint pen, press hard, and check all copies for legibility.

STEP 1. If the information in STEP 1 has not been completed, collector (not donor) completes STEP 1 (A-E).

NOTE: Donor refusal to provide SSN or Employee I.D. number must be annotated in STEP 5, collectorís REMARKS section.

STEP 2. Upon receiving specimen from donor, check specimen temperature. This must be accomplished within 4 minutes.

Check block marked "Yes" if temperature is within range.

If specimen temperature is not within range, check block marked "No," and record specimen temperature.

STEP 3. FOR SPLIT SPECIMEN COLLECTIONS ONLY

Secure caps on both specimen bottles and affix specimen bottle seal labelled A over the cap and down the sides of the primary specimen (bottle containing at least 30ml of urine).

After specimen bottle seal labelled B (split) on the split specimen (bottle containing at least 15ml of urine) in the same manner.

Record date on both specimen bottle seals.

Instruct donor to initial both specimen bottle seals.

FOR SINGLE SPECIMEN COLLECTION ONLY

Secure cap on specimen bottle (containing at least 30ml of urine) and affix specimen bottle seal labelled A over the cap and down the sides of the specimen bottle.

Record date on specimen bottle seal.

Instruct donor to initial the specimen bottle seal.

STEP 4. Turn to Copy 4 (pink page). STEP 4.

Instruct donor to complete STEP 4.

Ensure donor provides his/her daytime and evening phone number and date of birth.

Instruct donor to read certification statement. Ensure donor prints his/her name and signs and dates the certification statement.

NOTE: Donor refusal to sign must be annotated in STEP 5, collectorís remarks section.

Upon completion, check donor entries, return to Copy 1.

STEP 5. After returning to Copy 1, go to STEP 5.

Complete the name and address of the facility at which the collection is taking place.

List a business telephone number where collector can be reached.

Place a check in the box indicating whether or not a split specimen was collected.

Record any unusual occurrences concerning the collection (e.g., donor refusal to provide information/sign certification statement, specimen collected under direct observation, suspected adulteration) in the remarks section.

Collector completes certification section by printing and signing his/her name, recording the date and time of collection. Be sure to circle A.M. or P.M.

STEP 6. CHAIN OF CUSTODY SECTION

NOTE: Each time the specimen is handled, transferred, or placed into storage prior to being packaged for shipment, every individual must be identified (including a direct observer, if required) and the date and purpose of change recorded. The following instructions pertain to a collection in which the donor provides a specimen directly to the collector who seals, packages, and ships the specimen to the laboratory.

Record date of collection.

In the "Specimen Received By" column, sign and print your name indicating that you have received the specimen from the donor.

The "Purpose of Change" entry in the next column is pre-printed (Provide Specimen for Testing) and explains the transfer of the specimen from the donor to the collector.

On the next line, record the date the specimen was released by you.

Complete the "Specimen Released By" block by signing and printing your name.

If you are preparing the specimen for shipment to the laboratory, complete the "Specimen Received By" block by printing the carrier or shipment provider name only. (See Example)

Complete the "Purpose of Change" block explaining the transfer of the specimen from the collector to the carrier or shipment provider (e.g., Ship Specimen to Lab).

 

DATE

MO. DAY YR.

 

SPECIMEN RELEASED BY

 

SPECIMEN RECEIVED BY

 

PURPOSE OF CHANGE

 

8 / 15 / 94

 

DONOR - NO SIGNATURE

 

Signature Connie Collector

 

PROVIDE SPECIMEN FOR TESTING

 

Name Connie Collector

 

8 / 15 / 94

 

Signature Connie Collector

 

Signature ABC Courier Service

 

Ship Specimen to Lab

 

Name Connie Collector

 

Name

 

/ /

 

Signature

 

Signature

 

 

 

Name

 

Name

 

/ /

 

Signature

 

Signature

 

 

 

Name

 

Name

COMPLETING THE COLLECTION PROCESS

Upon completing Step 6, give donor his/her copy, Copy 5 (green page) of the Drug Testing Custody and Control Form.

Donor may leave the collection site at this point.

If a split specimen collection was performed, place both specimen bottles and Copies 1, 2, and 3 of the Drug Testing Custody and Control Form in the shipping container.

If a single collection was performed, place the specimen bottle and Copies 1 and 2 of the Drug Testing Custody and Control Form in the shipping container. Discard Copy 3.

Secure the shipping container. On the shipping container seal, record your initials and the date.

Send Copy 4 (pink page) directly to the Medical Review Officer. Do not send to laboratory.

Retain Copy 6 (yellow page) for your records.

Forward Copy 7 (blue page) to the employer. Do not send to laboratory.

Appendix C. Sample MRO Forms

 

SAMPLE MRO/DONOR INTERVIEW CHECKLIST

 

_____ (1) Identify yourself as the MRO for the employerís drug testing program.

(Give the donor your name and phone number)

_____ (2) Verify donorís identity (i.e., full name, SSN or donor I.D. #, date of birth)

_____ (3) Inform donor that medical information discussed during the interview is confidential, but may be disclosed under special circumstances

_____ (4) If donor holds a medical certificate under an agency rule, advise the donor that information regarding drug test results and information supplied by the donor will be provided to the Agency as required by appropriate regulation

_____ (5) Tell donor you are calling about the specific drug test he or she underwent on the specific date and the drug the specimen tested positive for

_____ (6) If donor requests the quantitative values, obtain them from the lab (MRO should not delay a verification decision pending receipt of the quantitative values)

_____ (7) Ask for recent medical history (when appropriate):

_____ Prescription drugs

_____ OTC drugs

_____ Medical procedures

_____ Food ingestion

 

_____ (8) Request donor to provide medical records or copies of prescriptions taken during the time of the drug test (when appropriate) and set a specific deadline for receiving the information

_____ (9) Request donor to undergo a medical examination or evaluation, when appropriate

_____ (10) Notify donor that he or she may request to have the split specimen tested (if a split specimen was collected) and explain the process; tell donor that the testing of a split specimen will not delay reporting the positive test result.

_____ (11) When the MRO review is complete, inform the donor that the appropriate employer official will be notified and tell the donor the result that will be reported

_____ (12) Offer to answer any further questions

SAMPLE MRO VERIFICATION WORKSHEET

Donor Name: _______________________________________________________

Last First Middle

Phone Number (Work): ________________ (Home): ___________________

Donor SSN or I.D. # ___________________ Specimen I.D. # ____________________

Date Lab Result Received: ______________

 

Donor Contact

Date of Initial Contact: ______________ Made by: ____________________________

 

_____ Donor refused to discuss a test result

_____ Unable to contact donor, all attempts failed

_____ Medical records are forthcoming. Date records made available: ____________.

_____ Date MRO interview conducted: _____________ Time: ___________

_____ Date medical examination conducted (if applicable)_________ Time: ____________

Examining Physicianís Name: ___________________________________

Address: ____________________________________________________

Phone # _________________

_____ Date retest ordered (if applicable): _____________________

Result and Date Received: _________________________________________

_____ Date split analysis ordered (if applicable): ________________

Result and Date Received: _________________________________________

 

Comments/Attempts to Contact Donor/Interview Details:

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Date donor notified of verified result: ____________

Date employer notified of verified result: __________

Employer: __________________________________

Employer contact: ____________________________

 

Verification Decision:

_____ Positive _____ Negative _____ Test Not Performed _____ Test Canceled

_____ Reconfirmed (Split Specimen Only) _____ Failed to Reconfirm (Split specimen Only)

Name of Drug (if positive): _____________________

Reason for Test Canceled/Test Not Performed: ______________________________________

_____________________________________________________________________________

 

___________________________________ ________________

MRO Signature Date

Appendix D. Examples of Case Studies

 

 

CASE #1

 

Lab Result: Positive for Cannabinoids (marijuana)

 

Collection: Single Specimen

CCF: The collector used the term "express carrier" in Step 6 on the CCF rather than providing the actual name of the carrier that delivered the specimen to the laboratory; otherwise, all information was correct and complete.

Discussion:

Since all the information appears to be forensically and scientifically acceptable except for the specific name of the courier being indicated on the CCF, the result will most likely be valid.

 

Before a final determination can be made, the MRO must discuss the result with the donor and contact the collector regarding the courier name.

 

During the donor interview, the donor states that he was at two parties over the weekend in which several individuals were smoking marijuana, but he did not smoke a joint. The donor describes the locations where the parties were held and states that one was in an apartment with five individuals sharing joints over a period of two hours and the other party was in a house with 20 people smoking several joints simultaneously for one hour. Although the circumstances do not support the possibility that passive inhalation could have caused the positive result, the MRO contacts the laboratory and is informed that the concentration of the marijuana metabolite was 30 ng/mL by GC/MS. The CCF shows that the donorís specimen was collected two days after the claimed passive exposure occurred.

 

Conclusion:

Based on the results of the passive exposure study described in a peer-reviewed scientific journal (E.J. Cone, et al., Passive Inhalation of Marijuana Smoke: Urinalysis and Room Air Levels of Delta-9-Tetrahydrocannabinol. J.Anal.Toxicol. 11:89-96(1987)), the exposure in this case was not of sufficient duration or intensity to cause a positive test for the marijuana metabolite by passive inhalation. It has been shown that the noxious smoke conditions needed for passive exposure is so extreme that it is highly improbable that an individual would unknowingly tolerate the exposure, that is, an individual would probably need to wear goggles to minimize eye irritation caused by the smoke. Therefore, if an individual was able to generate a positive test due to this type of extraordinary exposure, it simply represents another method of using marijuana and is not a legitimate alternative medical explanation.

With regard to using a general term to describe the courier rather than using a specific name, this is not a fatal flaw but does require some action. The MRO should contact the collector to determine why a specific courier name was not used. If the collector can provide a Memorandum For Record (MFR) that corrects the information (i.e., provides an explanation and gives the specific name of the courier), the flaw is considered to be recovered. The MFR is included in the records kept by the MRO. This procedure ensures that the collector is made aware that the specific name of the courier must be given on the CCF and should prevent the error from being repeated on other collections.

 

MRO Verified Result:

Positive for cannabinoids; however, if a MFR could not be obtained from the collector, the MRO should inform the employer that this flaw occurred on the CCF. Since the employer is ultimately responsible for defending the personnel actions taken against an employee based on a drug test result, it is the employerís responsibility to determine whether this flaw is sufficient to affect the forensic acceptability of the chain of custody. The employer may want to make this decision in consultation with legal counsel.

CASE #2

 

Lab Result: Positive for Morphine

 

Collection: Single Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

The MRO has a blanket request on file at the laboratory to obtain quantitations on morphine and/or codeine positive results at the time the positive result is reported. The following quantitative results were reported by the laboratory: morphine 5,200 ng/mL with no detectable concentration of codeine.

 

During the interview, the donor does not recall using any prescription medications that may have contained codeine or morphine. He also does not recall having eaten any poppy seeds around the time of the urine collection.

 

Based on the donorís claim that no prescription medication was taken or that he had not eaten poppy seeds, the MRO requested the laboratory to test the specimen for 6-acetylmorphine (6-AM). The laboratory reports no detectable amount of 6-AM.

 

Note: The Department of Health and Human has proposed raising the initial and confirmatory test levels for opiates to 2,000 ng/mL and to require testing for 6-AM when morphine is present above that level. After this change is implemented, the laboratory will automatically test this specimen for 6-AM.

 

The MRO conducts a physical examination of the donor and does not find any clinical evidence of abuse of opiates.

 

Conclusion:

Quantitative test results are consistent with poppy seed ingestion although the donor does not recall having eaten any prior to the drug test. The Mandatory Guidelines require an MRO to report a negative result when there is no clinical evidence of opiate abuse and 6-AM is not present.

 

MRO Verified Result: Negative

CASE #3

 

Lab Result: Positive for Codeine and Morphine

 

Collection: Split Specimen collection

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

The MRO has a blanket request on file at the laboratory to obtain quantitations on morphine and/or codeine positive results at the time the positive result is reported. The following quantitative results were reported by the laboratory: morphine 2,500 ng/mL and codeine 4,800 ng/mL.

 

Note: The Department of Health and Human has proposed raising the initial and confirmatory test levels for opiates to 2,000 ng/mL and to require testing for 6-AM when morphine is present above that level. After this change is implemented, the laboratory will automatically test this specimen for 6-AM.

 

During the interview, the donor denies using any prescription medication that may have contained codeine or morphine.

 

Since a split specimen was collected, the donor requests that the split specimen be tested in a second certified laboratory. The laboratory reconfirms the presence of codeine and morphine in the split specimen (Bottle B).

 

The MRO conducts a physical examination of the donor and does not find any clinical evidence of abuse of opiates.

 

Conclusion:

Although the quantitative test results indicate that a medication containing codeine was most likely taken by the donor, the Mandatory Guidelines require an MRO to report a negative result when there is no clinical evidence of abuse and 6-AM is not present.

 

MRO Verified Result: Negative

CASE #4

 

Lab Result: Positive for Codeine and Morphine

 

Collection: Single Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

During the interview, the donor states that he was taking a prescription medication that contained codeine (i.e., Tylenol with Codeine) at the time of the drug test.

 

Note: The donor submits a copy of his medical record to prove that the medication was properly prescribed to treat back pain during the time of the drug test.

 

The MRO has a blanket request on file at the laboratory and was given the following quantitative results: morphine was 6,350 ng/mL and codeine was 17,340 ng/mL.

 

Note: The Department of Health and Human has proposed raising the initial and confirmatory test levels for opiates to 2,000 ng/mL and to require testing for 6-AM when morphine is present above that level. After this change is implemented, the laboratory will automatically test this specimen for 6-AM.

 

Conclusion:

Since the donor provided a valid medication prescription to substantiate the positive codeine and morphine result, the MRO is not required to conduct a physical examination for clinical evidence of abuse.

 

MRO Verified Result:

A negative result is reported to the employer with regard to the workplace drug testing program. However, if the MRO believes that the medication might impact on the occupational and public safety associated with the donorís job, the MRO should contact the primary care physician or appropriate employer medical representative to express those concerns.

CASE #5

 

Lab Result: Positive for Methamphetamine

 

Collection: Single Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

During the interview, the donor denies taking any prescription medications, but had used some over-the-counter decongestants and used a Vicks Inhaler® at the time of the drug test.

 

The MRO contacts the laboratory to verify that amphetamine was also present in the specimen. The laboratory reports that the amphetamine concentration was 245 ng/mL and the methamphetamine was 950 ng/mL.

 

Note: Because the concentration of the methamphetamine is significantly higher than the amphetamine concentration, it appears that the amphetamine is present as a metabolite of methamphetamine.

 

The MRO requests the laboratory to perform a chiral analysis to determine which enantiomer(s) of methamphetamine and amphetamine is in the specimen. Since l-methamphetamine is a legitimate component of Vicks Inhaler®, he wants to be absolutely certain that the reported methamphetamine did not come from using the Vicks Inhaler®. The laboratory reports that approximately 90% of both the methamphetamine and amphetamine are the d-enantiomers. Since a Vicks Inhaler® contains l-methamphetamine, the d-methamphetamine and d-amphetamine could not come from the Vicks Inhaler®.

 

Conclusion:

The results indicate that the donor either used a prescription medication illegally or used an illegal source of methamphetamine. In either case, there is no valid medical explanation for the positive result.

 

MRO Verified Result: Positive

CASE #6

 

Lab Result: Positive for Cocaine

 

Collection: Single Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

During the interview, the donor denies using cocaine but claims that cocaine was used by a physician as a topical anesthetic prior to an endoscopic procedure.

 

The donor submits a copy of the medical record and the record clearly indicates the use of cocaine HCl; however, it was used one week prior to the date the urine was collected.

 

Conclusion:

Because the documented use of cocaine was one week prior to the drug test, the positive result could not have resulted from this legitimate medical use of cocaine. Generally, medically prescribed cocaine can only be detected in urine up to 2 days after use.

 

MRO Verified Result: Positive

CASE #7

 

Lab Result: Positive for Morphine

 

Collection: Split Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

The MRO has a blanket request on file at the laboratory to obtain quantitations on morphine and/or codeine positive results at the time the positive result is reported. The following quantitative results were reported by the laboratory: morphine 3,150 ng/mL and codeine 250 ng/mL.

 

Note: The Department of Health and Human has proposed raising the initial and confirmatory test levels for opiates to 2,000 ng/mL and to require testing for 6-AM when morphine is present above that level. After this change is implemented, the laboratory will automatically test this specimen for 6-AM but not report the codeine since it is below 2,000 ng/mL. The laboratory reports no detectable 6-AM.

 

During the interview, the donor states that he had taken an old prescription medication that he had gotten several months earlier after having had some oral surgery. The medication had been prescribed to control the pain after the surgery. The donor stated that he had some back pain a few days before the drug test and decided to take some of the medication.

 

The MRO requests the donor to bring him the medication and the label indicates that it is Tylenol with Codeine®. The donor does not request to have the split specimen tested because he agrees that this medication caused the positive result.

 

Conclusion:

Quantitative test results are consistent with taking a codeine containing medication. The MRO does not need to conduct a physical examination because the donor admits taking an old prescription medication (i.e., there is clinical evidence of illegal use of a drug). In this case, the donor used codeine illegally.

 

MRO Verified Result: Positive

CASE #8

 

Lab Result: Positive for Morphine

 

Collection: Single Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

The MRO has a blanket request on file at the laboratory to obtain quantitations on morphine and/or codeine positive results at the time the positive result is reported. The following quantitative results were reported by the laboratory: morphine 3,150 ng/mL and no detectable codeine. The MRO then requested an analysis for 6-acetylmorphine (6-AM). The laboratory reported no detectable 6-AM.

 

Note: The Department of Health and Human has proposed raising the initial and confirmatory test levels for opiates to 2,000 ng/mL and to require testing for 6-AM when morphine is present above that level. After this change is implemented, the laboratory will automatically test this specimen for 6-AM.

 

During the interview, the donor states that he was taking Percodan® at the time of the drug test. The donor also states that he routinely eats poppy seed bagels.

 

The MRO requests the donor to provide him a copy of his medical record. The record shows legitimate Percodan® use during that time.

 

Conclusion:

Percodan® cannot cause a morphine positive. The quantitative test result is consistent with eating poppy seeds. During the interview, the MRO is satisfied that there is no clinical evidence of using an illegal drug. Since the donor had used the Percodan® according to the physicianís instructions and had stopped using the medication three days after the drug test, there is no reason to contact the prescribing physician to discuss the donorís continued use of a medication that may have an impact on occupational and public safety. However, the MRO should inform the donor that taking any remaining Percodan® tablets after the intended use as prescribed by his physician is considered illegal and to caution him regarding the possible side effects that could impact occupational or public safety if the Percodan® tablets are taken.

 

MRO Verified Result: Negative

CASE #9

 

Lab Result: Positive for Methamphetamine

 

Collection: Single Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

Before a final determination can be made, the MRO must discuss the result with the donor.

 

The MRO obtains the following quantitative results from the laboratory: methamphetamine 1,250 ng/mL and amphetamine 225 ng/mL.

 

Note: Because the concentration of the methamphetamine is significantly higher than the amphetamine concentration, it appears that the amphetamine is present as a metabolite of methamphetamine.

 

During the interview, the MRO asked the donor to list the drugs he was taking at the time of the drug test and the donor stated that he was using a Vicks Inhaler® for sinus congestion and Valium® (diazepam) for anxiety.

 

Note: The donor volunteered this information because he thought the Valium® may have caused the positive drug test.

 

To determine if the methamphetamine came from Vicks Inhaler® use, the MRO requested the laboratory to perform a chiral analysis. The results showed that over 95% of the methamphetamine and amphetamine present in the urine were the l-enantiomers.

 

The MRO requests the donor to bring him a copy of his medical record. The record shows legitimate prescription use of the Valium®.

 

Conclusion:

The chiral analysis supports the use of a Vicks Inhaler®. Although the workplace drug testing program does not test for benzodiazepines (e.g., Valium®), the MRO has been given information by the donor that could potentially impact on the donorís safety or on public safety. The MRO should contact the prescribing physician to determine if the warnings associated with Valium® use have been discussed with the donor and taken into consideration with regard to dosage and possible side effects.

 

MRO Verified Result:

A negative result is reported to the employer with regard to the workplace drug testing program. Additionally, the legitimate use of Valium® is confidential medical information and may not be given to the employer unless its use is specifically prohibited by an applicable regulation or the MRO has a significant concern that use of the medication may impact occupational or public safety.

CASE #10

 

Lab Result: "TEST NOT PERFORMED" with a comment on the "REMARKS" line stating that the specimen had an unusual odor (possibly chlorine)

 

Collection: Split Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

 

The MRO calls the laboratory and requests the laboratory to send Bottle B to Laboratory B. The MRO tells the laboratory that the specimen was collected using a direct observed collection procedure (the MRO was the observer) and he believes the specimen is positive.

The Laboratory Director tells the MRO that the Bottle A specimen was negative on each immunoassay test although one of the readings suggested the possible presence of the marijuana metabolite below the initial test cutoff. Additionally, because the specimen definitely had a chlorine odor and had been adulterated, the laboratory marked "TEST NOT PERFORMED" on the custody and control form rather than "NEGATIVE."

 

Note: It appears that the observer did not actually watch the donor urinate into the collection container or specimen bottle or the collector/donor added an adulterant to the urine specimen after the observer left the collection site.

 

Conclusion:

 

The laboratory should have reported the test result as "NEGATIVE" because it had a valid negative initial test result for each drug class even though one of the readings suggested a drug metabolite may be present but below the initial test level. The comment on the "REMARKS" line was appropriate and would have alerted the MRO to a potential problem.

 

The MRO cannot request the laboratory to send Bottle B to Laboratory B to test for the five drug classes since the Bottle A specimen was negative for all drug classes. Only the donor, through the MRO, can request Bottle B to be tested.

 

MRO Verified Result:

 

Before making a determination, the MRO may request the laboratory to attempt to identify the specific adulterant that was added to the Bottle A specimen or request Laboratory A to send it to a laboratory that has the capability to possibly identify the adulterant. If the adulterant cannot be identified, the MRO must report the specimen as "NEGATIVE" because he was told by the Laboratory Director that the Bottle A specimen was negative on the five initial tests. Additionally, the MRO may recommend to the employer that another direct observed collection should be used the next time the donor is selected for a drug test. If the adulterant can be identified in the Bottle A specimen, the MRO should report this information to the employer and the employer should initiate a refusal to test action against the donor.

 

Note: In this case, Bottle B must be retained sealed by Laboratory A until its disposition has been determined by an appropriate administrative or judicial order or the donor.

CASE #11

 

Lab Result: Positive for Methamphetamine

 

Collection: Split Specimen

 

CCF: All information and signatures appear to be complete and correct

 

Discussion:

 

Before a final determination can be made, the MRO must discuss the result with the donor.

 

During the interview, the donor states that he has taken Adipex-P® (phentermine) for weight control, a free sample given to him by his physician (but he cannot remember the name of the sample), frequently uses a Vicks Inhaler® for a stuffy nose, and buys a number of nutritional supplements at a health food store.

 

The donorís physician was contacted and faxed a response indicating that she had given him free samples of Tenuate® to take before he should begin taking Adipex-P®.

 

The MRO contacted the laboratory and was told that neither Tenuate® nor Adipex-P® metabolizes to methamphetamine or amphetamine; however, the Vicks Inhaler® does contain l-methamphetamine.

 

To determine whether the Vicks Inhaler® caused the positive result, the MRO requested the laboratory to provide the quantitative result and to conduct a chiral analysis. The following results were reported:

 

Methamphetamine = 942 ng/mL

d-methamphetamine = 37%

l- methamphetamine = 63%

 

Conclusion:

Neither Tenuate® nor Adipex-P® were responsible for the presence of methamphetamine or amphetamine in this urine; neither of these products contains methamphetamine or amphetamine; neither of these products is metabolized to methamphetamine or amphetamine. If Vicks Inhaler® was the only source of methamphetamine in this urine, the percentage of l-methamphetamine would have been greater than 80%. The donor clearly ingested another source of methamphetamine containing the d-isomer.

 


MRO Verified Result: Positive

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