1 

2022 Medical Review Officer (MRO) Case Studies

These case studies provide examples to supplement the Department of Health and 

Human Services (HHS) MRO Guidance Manual, January 1, 2020. 

The manual and case studies apply to federal agency drug testing programs that come 

under Executive Order 12564 dated September 15, 1986, section 503 of Public Law 100-

71, 5 U.S.C. section 7301 note dated July 11, 1987, and the HHS Mandatory Guidelines for 

Federal Workplace Drug Testing Programs using Oral Fluid (October 25, 2019 Federal 

Register, 84 FR 57554), effective January 1, 2020. 

The manual and case studies do not apply to specimens submitted for testing under 

Department of Transportation (DOT) Procedures for Transportation Workplace Drug and 

Alcohol Testing Programs (49 CFR Part 40).

The MRO Case Studies will be updated as needed to reflect new information. The current 

version is available on the Drug Testing page under Medical Review Officer (MRO) 

Resources on the Substance Abuse and Mental Health Services Administration 

(SAMHSA) website:

https://www.samhsa.gov/workplace
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Table of Contents for Case Studies

Case #1 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 11 ng/mL ......... 4

Case #2 Laboratory Reported Result: Positive for Morphine – 135 ng/mL ........................ 5

Case #3 Laboratory Reported Result: Positive for Codeine – 143 ng/mL .......................... 6

Case #4 Laboratory Reported Result: Positive for Codeine – 340 ng/mL .......................... 7

Case #5 Laboratory Reported Result: Positive for Methamphetamine – 192 ng/mL ......... 8

Case #6 Laboratory Reported Result: Positive for Cocaine – 10 ng/mL and 

Cocaine Metabolite (Benzoylecgonine [BZE]) – 78 ng/mL ................................ 9

Case #7 Laboratory Reported Result: Positive for Morphine – 35 ng/mL ..........................10

Case #8 Laboratory Reported Result: Positive for Methamphetamine – 250 ng/mL 

and Amphetamine - 30 ng/mL .............................................................................11

Case #9 Laboratory Reported Result: Positive for Methamphetamine – 213 ng/mL ........13

Case #10 Laboratory Reported Result: Invalid Result–Immunoassay Interference.........15

Case #11 Laboratory Reported Result: Adulterated (Specify Adulterant) Present = 

(confirmatory test value) and Invalid Result – Tube A and Tube B – 

Different Physical Appearance ..........................................................................16

Case #12 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 2 ng/mL, 

Cocaine - 21 ng/mL, and Cocaine Metabolite (BZE) – 35 ng/mL ......................17

Case #13 Laboratory Reported Result: Rejected for Testing–Fatal Flaw: Tube A 

label/seal broken.................................................................................................18

Case #14 First Laboratory Reported Result: Negative and Invalid - Tube A and 

Tube B – Different Physical Appearance. Negative on second collection .........19

Case #15 Laboratory C Reported Result: Failed to Reconfirm Marijuana (THC) – 

Invalid due to Interference .................................................................................20

Case #16 Split Specimen Laboratory Reported Result: Failed to Reconfirm 

Cocaine Metabolite (BZE) – BZE not detected......................................................21

Case #17 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 3 ng/mL .........22

Case #18 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 14 ng/mL .......23

Case #19 Laboratory Reported Result: Positive for 6-Acetylmorphine (6-AM) – 5 

ng/mL ...................................................................................................................24

Case #20 Laboratory Reported Result: Rejected for Testing-Uncorrected Flaw: 

Collector signature not recovered.....................................................................25
3 

Case #21 Laboratory Reported Result: Positive for Cocaine - 12 ng/mL and 

Cocaine Metabolite (BZE) – 25 ng/mL ................................................................26

Case #22 Laboratory Reported Result: Positive for Codeine – 23 ng/mL and

Oxycodone – 30 ng/mL .......................................................................................27

Case #23 Laboratory Reported Result: Positive for Codeine – 35 ng/mL ..........................28

Case #24 Laboratory Reported Result: Positive for Hydromorphone – 23 ng/mL 

and Codeine – 31 ng/mL .....................................................................................30

Case #25 Laboratory Reported Result: Positive for Oxycodone – 37 ng/mL ....................32

Case #26 Laboratory Reported Result: Positive for Codeine – 17 ng/mL and

Morphine – 59 ng/mL ..........................................................................................33
4 

Case #1 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 11 ng/mL

Positive Drug (Marijuana)

Laboratory Report: The laboratory sent an electronic report and faxed a copy of the completed

Federal Drug Testing Custody and Control Form (CCF) (Copy 1). The information on the

electronic report matched the information on the Federal CCF. The collector used the term 

“express carrier” in Step 4 of the Federal CCF rather than stating the specific name of the

delivery service. Otherwise, the Federal CCF was properly completed by the collector and the 

laboratory. 

Discussion: A collector is required to provide the specific name of the delivery service on the

Federal CCF; however, it is considered an insignificant discrepancy when the correct name is 

not provided. No action is needed to correct the discrepancy.

Before a final determination can be made, the Medical Review Officer (MRO) must discuss the

positive test result with the donor. During the donor interview, the donor claims he tested positive 

because of passive inhalation. He states that he was at a party on Saturday night at which 

several individuals were smoking marijuana, but he did not smoke marijuana himself. The

Federal CCF documents that the donor’s specimen was collected three days after the claimed

passive exposure occurred.

Conclusion: Clinical studies have shown that it is highly unlikely that a non-smoking individual 

could inhale sufficient smoke by passive inhalation to result in a sufficient drug concentration in 

oral fluid for detection at the cutoff concentrations used in the federal agency program. The

circumstances described by the donor do not explain the presence of the marijuana (THC) in the

donor’s oral fluid. The MRO may not accept a claim that a laboratory positive THC result is due 

to passive inhalation of smoked marijuana or ingestion of edible products containing 

tetrahydrocannabinol (THC). 

MRO Reported Result: Positive for Marijuana. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs

(January 1, 2020), item 4.1.3.3.o, page 4-11; item 5.2, page 5-13. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.5.d.1. 

Cone, E.J., Bigelow, G.E., Herrmann, E.S., Mitchell, J.M., LoDico, C., Flegel, R., and Vandrey, 

R., Non-Smoker Exposure to Secondhand Cannabis Smoke. III. Oral Fluid and Blood 

Drug Concentrations and Corresponding Subjective Effects. Journal of Analytical 

Toxicology, Vol 39, July 2015.
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Case #2 Laboratory Reported Result: Positive for Morphine – 135 ng/mL 

Verified Negative Drug (Morphine)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor does not recall using any 

prescription medications that may have contained codeine or morphine. The donor also does not

recall having eaten any poppy seeds around the time of the oral fluid collection. In other words, 

the donor does not have an explanation for the positive result.

The MRO does not find any clinical evidence of abuse of opiates.

Conclusion: When there is no clinical evidence of abuse, and the oral fluid concentration of 

morphine is less than 150 ng/mL, the MRO is required to report the test result as Negative. 

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that, within the Department of Health and Human Services 

(HHS) program, the MRO is not required to discuss safety aspects of the donor’s job function. 

An MRO’s decision to contact an employer regarding safety issues related to a donor’s valid 

prescription (i.e., legal drug use) is subject to the MRO’s independent and voluntary choice and 

any obligations the MRO may have with the donor’s employing agency. Therefore, before 

discussing aspects of job safety with an agency, the MRO should review the terms of their 

service agreement with the agency and any agency policies or rules that govern issues related 

to safety and/or seek private legal counsel. HHS and the Substance Abuse and Mental Health 

Services Administration (SAMHSA) take no position regarding whether an MRO’s independent 

decision to disclose safety-related information (or other drug testing information, such as 

numerical values) in the context of a donor’s legal drug use is legal or appropriate in any given 

circumstance because this issue is outside the scope of the Mandatory Guidelines. Please refer 

to the MRO Guidance Manual, Chapter 6, Section 6.3, Occupational and Public Safety, 

regarding handling safety issues involving valid prescriptions.

MRO Reported Result: Negative. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.4.1, page 5-26; item 6.3, page 6-67. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d. 
6 

Case #3 Laboratory Reported Result: Positive for Codeine – 143 ng/mL 

Verified Negative Drug (Codeine)

Laboratory Report: The laboratory sent an electronic report and faxed a copy of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor denies using any medication that 

may have contained codeine or morphine.

The MRO 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 MRO is required to report a Negative result when there 

is no clinical evidence of abuse, and the concentrations of codeine or morphine are less than

150 ng/mL.

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that, within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

MRO Reported Result: Negative. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.4.1, page 5-26; item 6.3, page 6-67. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d. 
7 

Case #4 Laboratory Reported Result: Positive for Codeine – 340 ng/mL 

Verified Negative Drug (Codeine)

Laboratory Report: The laboratory sent an electronic report and faxed a copy of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor states that he was taking a 

prescription medication containing codeine (i.e., Tylenol with codeine) at the time of the drug 

test and the interview. The donor submits a copy of his medical record to prove that the

medication was properly prescribed to treat back pain.

Conclusion: The donor provided a valid prescription to substantiate the positive codeine result. 

Therefore, the MRO is not required to determine if there is any clinical evidence of abuse. 

MRO Reported Result: Negative. 

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and 

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.3, page 4-24; item 5.4.1, page 5-26; item 6.3, page 6-67; 

Table 4. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d. 
8 

Case #5 Laboratory Reported Result: Positive for Methamphetamine – 192 ng/mL 

Positive Drug (Methamphetamine)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor denies taking any prescription 

medications but states that he had used some over-the-counter (OTC) decongestants and a 

Vicks® VapoInhaler® at the time of the drug test.

The MRO sends a written request to the laboratory to obtain the quantitative amphetamine

result. The laboratory reports an amphetamine concentration of 12 ng/mL.

Note: Because methamphetamine metabolizes to amphetamine, the presence of amphetamine

is consistent with methamphetamine use. 

The MRO requests that the laboratory perform a chiral analysis to determine which enantiomers 

of methamphetamine are in the specimen. Because L-methamphetamine is a legitimate

component of some OTC nasal decongestant products, the MRO wants to be certain that the

reported methamphetamine is not attributable to using a decongestant inhaler. The laboratory 

reports that approximately 90 percent of the methamphetamine is the D-enantiomer. Some 

decongestant inhalers contain L-methamphetamine (listed in the ingredients as 

levmetamfetamine); however, D-methamphetamine cannot be ascribed to the use of an OTC 

product. 

Conclusion: The donor does not have a valid prescription or other authorization to use 

methamphetamine and does not provide a legitimate medical explanation for the positive drug 

test result.

MRO Reported Result: Positive for Methamphetamine

Note: Early in 2016, levmetamfetamine (L-methamphetamine) was removed from the Vicks® 

VapoInhaler®, and a reformulated inhaler was reintroduced to the market. However, a number 

of decongestant inhalers on the OTC market contain L-methamphetamine. This ingredient (Lmethamphetamine) may also be identified as levmetamfetamine, L-desoxyephedrine, or 

levomethamphetamine. Examples of current levmetamfetamine products include but are not 

limited to Amoray® Vaporizing Inhaler (in which it is not listed as an active ingredient), NeilMed 

Sinu Inhaler®, and Equate® Vapor Inhaler. In addition, Vicks® VapoInhalers® containing Lmethamphetamine may remain in some medicine cabinets.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.1.1, page 5-2; Table 6.

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 3.5. 
9 

Case #6 Laboratory Reported Result: Positive for Cocaine – 10 ng/mL and Cocaine

Metabolite (Benzoylecgonine [BZE]) – 78 ng/mL 

Positive Drug (Cocaine, Cocaine Metabolite)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor denies using cocaine but claims that 

cocaine was used as a topical anesthetic prior to a laryngoscopic procedure. The donor submits 

a copy of the medical record that documented the use of cocaine for the procedure, and the

MRO verifies that use with the physician who performed the procedure. The medical record 

supports the use of cocaine hydrochloride; however, this drug was used 10 days before the oral 

fluid specimen was collected.

Conclusion: Because the documented use of cocaine occurred 10 days before the drug test, 

the positive result cannot be attributed to this medical use of cocaine. Generally, the detection

window for the cocaine metabolite in oral fluid is two to three days after use when using the

cutoff concentrations required for testing federally regulated specimens.

MRO Reported Result: Positive for Cocaine and Cocaine Metabolite. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.3, page 5-20. 
10

Case #7 Laboratory Reported Result: Positive for Morphine – 35 ng/mL 

Verified Negative Drug (Morphine)

Laboratory Report: The laboratory sent an electronic report and faxed a copy of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor states that he was taking Ultram® 

(tramadol) at the time that he submitted his oral fluid specimen. The donor also states that he 

routinely eats poppy seed bagels. 

During the interview, the MRO is satisfied that there is no clinical evidence of opiate abuse. 

Conclusion: The morphine concentration is consistent with eating poppy seeds. Additionally, 

Ultram® cannot cause an oral fluid specimen to test positive for morphine because tramadol

does not metabolize to morphine. When there is no clinical evidence of abuse, and the oral fluid 

concentration of morphine is less than 150 ng/mL, the MRO is required to report the test result 

as Negative.

MRO Reported Result: Negative. 

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.3, page 4-24; item 5.4.1, page 5-26; item 6.3, page 6-67. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d. 
11

Case #8 Laboratory Reported Result: Positive for Methamphetamine – 250 ng/mL and

Amphetamine - 30 ng/mL 

Verified Negative Drugs (Methamphetamine, Amphetamine)

Laboratory Report: The laboratory sent an electronic report and faxed a copy of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory. The

MRO had a blanket request on file at the laboratory to receive quantitative amphetamine results

for all specimens reported positive for methamphetamine.

Discussion: Note: Because the methamphetamine concentration is significantly higher than the

amphetamine concentration, the amphetamine appears to be present as a metabolite of 

methamphetamine.

During the interview with the donor, the MRO asks the donor to list the drugs he was taking at 

the time of the drug test, and the donor states that he was using a decongestant 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 whether the methamphetamine came from decongestant inhaler use, the MRO 

requests that the laboratory perform a chiral analysis to determine which enantiomers of 

methamphetamine are in the specimen. The chiral analysis results show that over 95 percent of 

the methamphetamine present in the oral fluid was the L-enantiomer. 

Conclusion: The chiral analysis supports the use of an OTC decongestant inhaler as the reason

for the positive drug test result. 

MRO Reported Result: Negative.

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and 

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 
12

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

Note: Early in 2016, levmetamfetamine (L-methamphetamine) was removed from the Vicks® 

VapoInhaler®, and a reformulated inhaler was reintroduced to the market. However, a number 

of decongestant inhalers on the OTC market contain L-methamphetamine. This ingredient (Lmethamphetamine) may also be identified as levmetamfetamine, L-desoxyephedrine, or 

levomethamphetamine. Examples of current levmetamfetamine products include but are not 

limited to Amoray® Vaporizing Inhaler (in which it is not listed as an active ingredient), NeilMed 

Sinu Inhaler®, and Equate® Vapor Inhaler. In addition, Vicks® VapoInhalers® containing Lmethamphetamine may remain in some medicine cabinets.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.3, page 4-24; item 5.1.1, page 5-2; item 6.3, page 6-67; 

Table 6.

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d. 
13

Case #9 Laboratory Reported Result: Positive for Methamphetamine – 213 ng/mL 

Positive Drug (Methamphetamine)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory. The

MRO had a blanket request on file at the laboratory to receive quantitative amphetamine results

for all specimens reported positive for methamphetamine.

Discussion: During the interview with the donor, the donor states that he had taken Adipex-P® 

(phentermine) for weight control, had taken a free sample given to him by his physician (but 

could not remember the name of the sample), frequently uses an OTC decongestant inhaler for

a stuffy nose, and uses several nutritional supplements from a health food store. 

The MRO contacts the donor’s physician, who indicates that she had given the donor free

samples of Tenuate® (diethylpropion HCl) to take before taking Adipex-P®.

The MRO contacts the laboratory and is told that neither diethylpropion nor phentermine 

metabolize to methamphetamine or amphetamine; however, the OTC decongestant inhaler does 

contain levmetamfetamine (L-methamphetamine). (Table 6 of the MRO manual lists other drugs 

that may be metabolized to amphetamine or methamphetamine.)

To determine whether the decongestant inhaler caused the positive result, the MRO requests that

the laboratory conduct a chiral analysis to determine which enantiomers of methamphetamine

are in the specimen. The laboratory reports the following results: 37 percent Dmethamphetamine and 63 percent L-methamphetamine.

Conclusion: Tenuate® and Adipex-P® are not responsible for the presence of 

methamphetamine in this oral fluid specimen. None of these products contains 

methamphetamine or amphetamine, and neither of these products is metabolized to

methamphetamine or amphetamine. In addition, nutritional supplements do not explain the drug

test results. If the OTC decongestant inhaler were the only source of methamphetamine in this 

oral fluid, the percentage of L-methamphetamine would have been greater than 80 percent.

Thus, the donor ingested another source of methamphetamine containing the D-isomer.

MRO Reported Result: Positive for Methamphetamine. 

Note: An MRO may request enantiomeric testing with a blanket request (i.e., a request for 

enantiomeric testing of all methamphetamine-positive specimens or all specimens with a 

positive amphetamine initial test) or on an individual specimen basis. MRO requests are not 

needed if the laboratory reflexes ALL regulated specimens to enantiomeric testing based on 

positive initial or confirmatory test results.

Note: Early in 2016, levmetamfetamine (L-methamphetamine) was removed from the Vicks® 

VapoInhaler®, and a reformulated inhaler was reintroduced to the market. However, a number 

of decongestant inhalers on the OTC market contain L-methamphetamine. This ingredient (Lmethamphetamine) may also be identified as levmetamfetamine, L-desoxyephedrine, or 
14

levomethamphetamine. Examples of current levmetamfetamine products include but are not 

limited to Amoray® Vaporizing Inhaler (in which it is not listed as an active ingredient), NeilMed 

Sinu Inhaler®, and Equate® Vapor Inhaler. In addition, Vicks® VapoInhalers® containing Lmethamphetamine may remain in some medicine cabinets.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.1.1, page 5-2; Table 6.

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 3.5. 
15

Case #10 Laboratory Reported Result: Invalid Result–Immunoassay Interference

Cancelled Test (Invalid Specimen); Immunoassay Interference and SVT (Albumin, IgG)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: The MRO discusses the results with the donor, and the donor denies tampering

with the oral fluid specimen. To obtain additional information, the MRO requests additional SVT 

testing for Tube A using albumin and immunoglobulin G (IgG). Albumin and IgG are biomarkers 

that can be used to determine if the oral fluid specimen is valid. The oral fluid SVT results 

indicate an invalid specimen with albumin and IgG below the laboratory’s limit of detection/limit 

of quantification (LOD/LOQ). 

Note: Oral fluid drug testing does not routinely include specimen validity testing (SVT). The 

MRO may order SVT when the specimen exhibits abnormal characteristics (e.g., unusual odor 

or color), causes reactions or responses characteristic of an adulterant during initial or 

confirmatory drug tests (e.g., non-recovery of internal standard, unusual response), or 

contains an unidentified substance that interferes with the confirmatory analysis,

Conclusion: The MRO is required to contact the donor and give the donor an opportunity to

explain the Invalid result. For this oral fluid specimen, the SVT and Invalid results provide 

additional information that may be useful if the donor requests that the split (Tube B) specimen

be tested by a second certified laboratory. If a laboratory is unable to perform or complete testing of 

a primary specimen, the MRO may request that the specimen be sent to another HHS-certified 

laboratory for additional/different testing.

MRO Reported Result: Cancelled Test: Invalid Specimen: Immunoassay interference and 

Abnormal SVT. The MRO directs the agency to immediately collect another specimen using a 

direct observed collection procedure and reports the cancelled test to the appropriate regulatory 

office.

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.2, page 4-16; item 4.3, page 4-19; item 4.5.1, page 4-23; item 

5.6.4.1.b, page 5-53; Appendix D; Table 4.

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554 

(October 25, 2019), Section 3.5. 
16

Case #11 Laboratory Reported Result: Adulterated (Specify Adulterant) Present = 

(confirmatory test value) and Invalid Result – Tube A and Tube B – Different Physical 

Appearance

Refusal to Test (Adulterated) 

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: The laboratory contacts the MRO to discuss the invalid result prior to reporting. 

The MRO discusses the results with the donor, and the donor denies tampering with the oral 

fluid specimen.

Conclusion: Although the MRO is required to contact the donor and give the donor an 

opportunity to explain the adulterated result, the criteria established by the Mandatory 

Guidelines to report a specimen as adulterated preclude any legitimate medical explanation 

for the presence of an adulterant. For this oral fluid specimen, the invalid result provides 

additional information that may be useful if the donor requests that the split (Tube B) 

specimen be tested by a second certified laboratory. The fact that Tube A and Tube B have 

a different physical appearance may suggest that the identified adulterant would not be 

reconfirmed in the split (Tube B) specimen.

Generally, the MRO reports all positive, adulterated, invalid, and (for urine) substituted

results to the Federal agency. However, in this case, the MRO should report only the 

adulterated result to the agency. The MRO only reports the invalid result to the agency if the 

split specimen is tested and fails to reconfirm as adulterated. The reason for the invalid 

result (Tube A and Tube B – Different Physical Appearance) will most likely have an impact 

on the reported result if the donor requests that the split (Tube B) specimen be tested for the

adulterant reported in the primary (Tube A) specimen.

MRO Reported Result: Refusal to Test (Adulterated). 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.2, page 4-16; item 4.3, page 4-19; item 5.6.3.2, page 5-51; 

item 5.6.4.1.b, page 5-53; Appendix D; Table 4. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554 

(October 25, 2019), Section 13.5. 
17

Case #12 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 2 ng/mL, 

Cocaine - 21 ng/mL, and Cocaine Metabolite (BZE) – 35 ng/mL 

Positive Drugs (Cocaine, Cocaine Metabolite, Marijuana)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor claims that he tested positive for

marijuana because he was at a party and had eaten brownies that contained marijuana and that 

he tested positive for cocaine because a dentist had used lidocaine prior to a dental procedure. 

The Federal CCF documented that the donor’s specimen was collected two days after he

claimed to have eaten the brownies and one day after the dental procedure.

Conclusion: Donors have claimed unknowingly ingesting marijuana in brownies to explain 

positive test results for many years. Given the current concentrations of THC found in edibles, it 

is possible that after ingesting brownies, a donor’s oral fluid drug test may be positive for the 

marijuana THC. The MRO may not accept a claim that a laboratory positive result is the result of 

passive inhalation or ingestion of edible products containing THC. With regard to the cocaine 

metabolite, lidocaine does not contain cocaine and does not metabolize to either cocaine or the

cocaine metabolite. 

MRO Reported Result: Positive for Marijuana, Cocaine and Cocaine Metabolite. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.2, page 5-13; item 5.3, page 5-20. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.5.d.1. 
18

Case #13 Laboratory Reported Result: Rejected for Testing – Fatal Flaw: Tube A 

label/seal broken

Cancelled Test (Fatal Flaw: Label/Seal Broken)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: The Mandatory Guidelines designate some specific specimen and documentation

problems as either “fatal flaws” or “correctable flaws.” Laboratories generally identify fatal flaws 

during receipt and accessioning and do not test such specimens or stop testing if the flaw is 

identified after testing has been initiated. For errors that require the laboratory to reject the 

specimen if not corrected, the laboratory must accession and hold the specimen while taking 

action to resolve the problem (i.e., by obtaining a memorandum for the record [MFR], from the

collector). The laboratory must delay testing the specimen until the collector provides the

documentation to recover these correctable flaws. 

A broken seal on a primary (Tube A) specimen is fatal unless the split (Tube B) specimen can be

redesignated as the primary (Tube A) specimen. Tube B may be redesignated as Tube A if the

volume of oral fluid in Tube B is sufficient to conduct the required tests, and the tube seal is 

intact. In that case, the laboratory will test Tube B and report a result. When redesignation

occurs, the laboratory notes the redesignation on the CCF. If and when the specimen is reported

Positive, Invalid, or Adulterated, and the donor requests a retest of the split (Tube B) specimen, 

the laboratory will inform the MRO that a split specimen is not available.

Conclusion: Because the laboratory rejected the specimen for testing, and there was no 

documentation of redesignation, the MRO confirmed with the laboratory that it was not possible to 

redesignate the specimens (i.e., Tube B as Tube A). 

MRO Reported Result: Test Cancelled: Fatal Flaw: Tube A seal broken. The MRO reports the 

cancellation and the reason to the federal agency, which then determines whether or not to 

immediately collect another oral fluid specimen from the donor.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.1.3, page 4-8; Table 4.

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.5.h. 
19

Case #14 First Laboratory Reported Result: Negative and Invalid - Tube A and Tube B – 

Different Physical Appearance. Negative on second collection

Cancelled Test (Different Physical Appearance); Negative Test (Recollection)

Laboratory Report: The laboratory sent an electronic report and faxed the completed Federal

CCF (Copy 1). The information on the electronic report matched the information on the Federal 

CCF. The Federal CCF was properly completed by the collector and the laboratory. 

Note: Laboratories are required to test Tube A when a specimen meets the criteria for reporting

as Invalid based on Tube A and Tube B – Different Physical Appearance. Prior to reporting the 

Invalid result (Tube A and Tube B-Different Physical Appearance), the laboratory must contact 

the MRO to decide whether additional/different testing would be of use to obtain a definitive 

result.

Discussion: The CCF includes no collector or laboratory remarks indicating a problem with the

collection or the specimen. During the interview with the donor, the donor gives no explanation

for the Invalid result. He denies having tampered with the specimen.

Conclusion: The contents of Tube A and Tube B appear not to represent a proper split 

specimen collection or that something was added to one tube but not the other.

MRO Reported Result: Test Cancelled: Invalid Result–Different Physical Appearance. The 

MRO directs the agency to immediately collect another specimen using a direct observed

collection procedure and reports the cancelled test to the appropriate regulatory office.

Second (re-collected) Laboratory Reported Result: Negative. 

Laboratory Report: The laboratory sent an electronic report and an image of the completed 

Federal CCF (Copy 1) to the MRO. The information on the electronic report matched the

information on the Federal CCF. The Federal CCF was properly completed by the collector and 

the laboratory.

Discussion: This is the second specimen collected. 

Conclusion: The specimen result is valid. The MRO reports the result. 

MRO Reported Result: Negative. 

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.2, page 4-24; item 5.6.4, page 5-51. 
20

Case #15 Laboratory C Reported Result: Failed to Reconfirm Marijuana (THC) – Invalid 

due to Interference

Test Cancelled (Failed to Reconfirm)

Split Specimen Laboratory Reported Result: Failed to Reconfirm for Marijuana (THC) –

Reason: Invalid Result–LC-MS/MS interference. 

Discussion: Laboratory B received the split (Tube B) specimen from the primary laboratory with

a copy of the MRO’s request to test the split specimen for marijuana (THC), the drug that was 

reported positive in the primary (Tube A) specimen. When Laboratory B was unable to reconfirm 

the presence of THC, the laboratory consulted with the National Laboratory Certification Program 

(NLCP) to identify another HHS-certified laboratory that may be able to perform the test needed to 

reconfirm or refute the primary (A) specimen results. Laboratory B contacted the MRO to provide 

information to assist the MRO in deciding whether to send the split specimen to a third 

laboratory (Laboratory C). After discussing the results with Laboratory B, the MRO decides to

send the specimen to Laboratory C for split specimen (B) testing. 

Laboratory B Report: Laboratory B does not issue a report for a split specimen that fails to 

reconfirm when the MRO decides to send the split specimen to Laboratory C 

Laboratory C Report: Laboratory C faxed a copy of the completed Federal CCF (Copy 1) and 

its Split Specimen Report for the specimen. Laboratory C properly completed Step 5b on the 

Federal CCF. The Split Specimen Report contained additional explanatory information as 

required, including the results of invalid due to confirmatory test method (LC-MS/MS)

interference, and was signed and dated by the certifying scientist.

Discussion: Laboratory C received the split (Tube B) specimen from the Laboratory B with a 

copy of the MRO’s request to retest the split specimen for marijuana (THC), the drug that was 

reported positive in the primary (Tube A) specimen. Laboratory C was also unable to reconfirm 

the presence of THC due to interference. 

Conclusion: Laboratory C Failed to Reconfirm marijuana (THC) due to interference with the LCMS/MS THC method. 

MRO Reported Result: Failed to Reconfirm for Marijuana (THC), Invalid Result–LC-MS/MS 

interference, and Test Cancelled for both the primary and split specimens. The MRO directs the

agency to immediately collect another specimen using a direct observed collection procedure

and reports the failed to reconfirm and cancelled test to the appropriate regulatory office.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 3.2.4.2, page 3-12; item 5.6.4, page 5-51; Appendix D, Table 5.
21

Case #16 Split Specimen Laboratory Reported Result: Failed to Reconfirm Cocaine 

Metabolite (BZE) – BZE not detected 

Test Cancelled (Failed to Reconfirm)

Laboratory B Report: Laboratory B faxed a copy of the completed Federal CCF (Copy 1) and 

its Split Specimen Report for the specimen. Laboratory B properly completed Step 5b on the 

Federal CCF. The Split Specimen Report contained additional explanatory information as 

required, and was signed and dated by the certifying scientist.

Discussion: Laboratory B received the split (Tube B) specimen from the primary laboratory with

a copy of the MRO’s request to test the split specimen for BZE, the drug metabolite reported

positive in the primary (Tube A) specimen. The copy of the Federal CCF (Copy 1) sent with the

specimen documented Laboratory A’s reported concentration of 20 ng/mL BZE. When

Laboratory B was unable to reconfirm the presence of BZE and there was no evidence to 

support reporting an Invalid result, results were reported as Failed to Reconfirm. 

If Laboratory B believes that BZE may be present in the split specimen but cannot obtain a valid 

result (e.g., because of an interferent affecting its assay), Laboratory B must contact the MRO to

decide whether testing at a third laboratory would be useful. In this case, Laboratory B did not 

contact the MRO to discuss this possibility because its confirmatory drug test indicated that BZE 

was not present in the split (Tube B) specimen.

Conclusion: There is no apparent reason for the discrepancy in the results for the primary 

(Tube A) and split (Tube B) specimens.

MRO Reported Result: Failed to Reconfirm for Cocaine Metabolite and Test Cancelled for both

the primary and split specimens. The MRO reports the failed to reconfirm and cancelled test to

the appropriate regulatory office.

Note: The Mandatory Guidelines do not require the MRO to direct the agency to complete an 

additional collection. This case does not state that a Negative result is needed for a federal 

agency applicant/pre-employment, return-to-duty, or follow-up test; however, if the agency 

needs a Negative result for any of those purposes, the agency can request a second collection.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 3.2.4.2, page 3-12; Appendix D; Table 5. 
22

Case #17 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 3 ng/mL 

Positive Drug (Marijuana); CBD use

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor admits cannabidiol (CBD) use. The

donor produces a bottle of CBD, which is legal in the donor’s state of residence. The donor

claims that he consumes multiple doses daily of CBD products to alleviate back pain and to treat 

his diabetes.

Conclusion: A positive test can result from cannabis use or use of a CBD product that contains 

THC. Under the Federal Drug-Free Workplace Program, there is no legitimate medical 

explanation for a marijuana positive test result other than a verified prescription for Marinol®, 

Sativex® or generic equivalent. The donor’s CBD use may be consistent with the positive drug

test result and does not constitute a legitimate medical explanation for the drug test result. 

MRO Reported Result: Positive for Marijuana.

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.2, page 5-13. 
23

Case #18 Laboratory Reported Result: Positive for Marijuana (Δ9-THC) – 14 ng/mL 

Positive Drug (Marijuana); Medical Marijuana

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor admits marijuana use. However, the

donor produces an order for medical marijuana, which is legal in the donor’s state of residence. 

The donor claims that his physician prescribed marijuana to alleviate shoulder pain from a 

previous work injury and states that he only uses marijuana on weekends when he does not 

work. 

Conclusion: The donor’s marijuana use is consistent with the positive drug test result. At this 

time, marijuana remains a Schedule I drug, and medical marijuana use is not an acceptable 

medical explanation for a positive drug test result in any federal agency drug testing program. A 

written recommendation from a licensed physician or medical professional does not exempt the 

donor from this rule. If the donor admits the use of medical marijuana, the MRO verifies the 

result as positive.

MRO Reported Result: Positive for Marijuana. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.2, page 5-13. 
24

Case #19 Laboratory Reported Result: Positive for 6-Acetylmorphine (6-AM) – 5 ng/mL 

Positive Drug (6-AM)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: Note: Although morphine is generally present (i.e., at or above the program cutoff 

of 15 ng/mL) in positive 6-AM specimens, morphine may not be present or may be present 

below 15 ng/mL in a positive 6-AM specimen for several reasons. For example, the donor may 

have used heroin close to the time of collection; the donor may have a metabolic defect in the 

metabolism of 6-AM, resulting in prolonged excretion; the donor’s morphine metabolic pathways 

may have been altered; or another substance may have interacted with 6-AM or morphine.

During the interview with the donor, the donor denies heroin use. 

Conclusion: When a laboratory reports a specimen as positive for the heroin metabolite (6-AM), 

it is proof of heroin use. There is no legitimate medical explanation for a positive 6-AM result.

MRO Reported Result: Positive for 6-AM. 

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 5.4.4, page 5-38.
25

Case #20 Laboratory Reported Result: Rejected for Testing-Uncorrected Flaw: Collector 

signature not recovered

Cancelled Test; Collector Errors; MRO Responsibilities 

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1) and an MFR from the collector. The collector had printed his name but 

had not signed the Federal CCF in Step 4. A missing collector signature is a recoverable flaw. The

information on the electronic report matched the information on the Federal CCF. The Federal 

CCF was properly completed by the laboratory. 

Discussion: The Mandatory Guidelines designate some specific specimen and documentation

problems as either “fatal flaws” or “correctable flaws.” Laboratories generally identify fatal flaws 

during receipt and accessioning and do not test such specimens or stop testing if the flaw is 

identified after testing has been initiated. For errors that require the laboratory to reject the 

specimen if not corrected, the laboratory must accession and hold the specimen while taking 

action to resolve the problem (i.e., by obtaining a memorandum for the record [MFR], from the

collector). The laboratory must delay testing the specimen until the collector provides the

documentation to recover these correctable flaws. 

The laboratory faxed a MFR to the collector to recover the missing signature. After 5 business 

days, the collector had not responded to the MFR and the laboratory reported Rejected for 

Testing: Uncorrected Flaw: Collector signature not recovered result to the MRO. 

In reviewing his records, the MRO notes that the same collector had omitted his signature on the

CCF for another specimen collected one week earlier. The MRO should monitor the frequency

of documentation errors, notify the responsible party (e.g., collector, laboratory) when an error

occurs more than once a month, and direct them to take corrective action to prevent recurrence 

of the errors. 

Conclusion: The laboratory reported Rejected for Testing after waiting 5 business days to 

recover the missing collector signature. 

MRO Reported Result: Test Cancelled and Remark: Rejected for Testing-Uncorrected Flaw: 

Collector signature not recovered. The MRO reports the cancellation and the reason to the 

federal agency, which then determines whether or not to immediately collect another oral fluid 

specimen from the donor.

Additional MRO Actions: The MRO should send a letter notifying the collector employer or 

collector (if self-employed) of the errors and the need for corrective action. The MRO should 

also send a copy of the letter to the federal agency for follow-up.

References: 

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.1.3.2.a, page 4-9; item 4.1.5, page 4-13. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.4.f. 
26

Case #21 Laboratory Reported Result: Positive for Cocaine - 12 ng/mL and Cocaine

Metabolite (BZE) – 25 ng/mL 

Positive Drugs (Cocaine, Cocaine Metabolite); Collector Errors; MRO Responsibilities

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1) and an MFR from the collector. The collector had printed his name but 

had not signed the Federal CCF in Step 4. A missing collector signature is a recoverable flaw. The

information on the electronic report matched the information on the Federal CCF. The Federal 

CCF was properly completed by the laboratory. 

Discussion: The Mandatory Guidelines designate some specific specimen and documentation

problems as either “fatal flaws” or “correctable flaws.” Laboratories generally identify fatal flaws 

during receipt and accessioning and do not test such specimens or stop testing if the flaw is 

identified after testing has been initiated. For errors that require the laboratory to reject the 

specimen if not corrected, the laboratory must accession and hold the specimen while taking 

action to resolve the problem (i.e., by obtaining a memorandum for the record [MFR], from the

collector). The laboratory must delay testing the specimen until the collector provides the

documentation to recover these correctable flaws. 

The laboratory faxed a MFR to the collector to recover the missing collector signature. The 

collector responded to the MFR within 5 business days. The collector’s MFR response 

addresses the signature omission and was sent to the laboratory the day after specimen receipt.

There are no other problems with the submitted documents. The MRO conducts the donor

interview and reports the specimen as Positive for Cocaine and Cocaine Metabolite to the

federal agency.

In reviewing his records, the MRO notes that the same collector had omitted his signature on the

CCF for another specimen collected one week earlier. The MRO should monitor the frequency

of documentation errors, notify the responsible party (e.g., collector, laboratory) when an error

occurs more than once a month, and direct them to take corrective action to prevent recurrence 

of the errors. 

MRO Reported Result: Positive for Cocaine and Cocaine Metabolite

Additional MRO Actions: The MRO should send a letter notifying the collector employer or 

collector (if self-employed) of the errors and the need for corrective action. The MRO should 

also send a copy of the letter to the federal agency for follow-up.

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.1.3, page 4-8; item 5.3, page 5-20. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 15.3.c. 
27

Case #22 Laboratory Reported Result: Positive for Codeine – 23 ng/mL and Oxycodone – 

30 ng/mL 

Positive Drug (Oxycodone); Verified Negative Drug (Codeine)

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the 

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor states that he was taking a 

prescription medication—APAP #4—at the time of the drug test and the interview. The donor

submits a copy of his medical record to prove that the medication was properly prescribed to 

treat back pain. The donor is unable to provide additional medical information. 

Conclusion: Although the donor provides documentation to support the laboratory findings of 

codeine, the documentation provided does not support the finding of oxycodone.

MRO Reported Result: Positive for Oxycodone. 

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.2, page 4-24; item 4.5.3, page 4-24; item 5.4.1, page 5-26; 

item 5.4.2, page 5-31. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.5.d. 
28

Case #23 Laboratory Reported Result: Positive for Codeine – 35 ng/mL 

Verified Negative Drug (Codeine); Possible Safety Concerns

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the 

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor states that, at the time of the drug 

test and the interview, he was using a fentanyl patch prescribed for pain control after recent back 

surgery. He also reports contracting a recent upper respiratory infection (URI) from his spouse. 

During his last URI, he remembered using a behind-the-pharmacy-counter cough preparation

containing codeine, which he obtained from the local pharmacy. The donor submits a copy of the 

pharmacy record showing that he had received a codeine cough preparation the same day as

the specimen collection. 

Conclusion: Fentanyl will not cause a positive test result under the Federal Drug-Free 

Workplace Program. Codeine preparations are available behind the pharmacy counter in some 

states, but their distribution must be recorded by the pharmacist. The MRO must ensure that the 

codeine cough preparation was dispensed prior to the time the specimen was collected. The 

codeine level measured in this case was less than 150 ng/mL and was likely attributable to the 

legitimate use of a codeine medication.

MRO Reported Result: Negative.

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to drug information disclosed by the donor during the interview with the MRO 

(i.e., use of a prescription drug that is not tested under the federal program) or a drug reported 

as Positive by the laboratory that is reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and 

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.2, page 4-24; item 5.4.1, page 5-26; item 6.3, page 6-67. 
29

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d. 
30

Case #24 Laboratory Reported Result: Positive for Hydromorphone – 23 ng/mL and

Codeine – 31 ng/mL 

Verified Negative Drugs (Hydromorphone, Codeine); Possible Safety Concerns

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the 

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the MRO, the donor states that at the time of the drug test 

and the interview, he was taking Dilaudid® (hydromorphone), which was prescribed for pain 

control after a recent femur fracture. He provides a report from his personal physician and 

records from the pharmacy showing the drug was dispensed one week before the specimen

collection. He offers no records or comment regarding the codeine found. 

Additionally, the MRO does not find any clinical evidence of abuse of opiates.

Conclusion: The Dilaudid prescription would justify the laboratory findings, but hydromorphone 

does not metabolize to codeine. When there is no clinical evidence of abuse, and the oral fluid 

concentration of morphine is less than 150 ng/mL, the MRO is required to report the test result 

as Negative.

MRO Reported Result: Negative. 

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and 

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.3, page 4-24; item 5.4.1, page 5-26; item 5.4.2, page 531; 

item 6.3, page 6-67. 
31

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d.
32

Case #25 Laboratory Reported Result: Positive for Oxycodone – 37 ng/mL 

Verified Negative Drug (Oxycodone); Possible Safety Concerns

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the 

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor states that she had been taking 

OxyContin® (oxycodone) since she slipped and fell on her tail bone 14 months ago. The donor

submits a copy of her medical record to prove that the medication was properly prescribed and a 

record from the pharmacy showing that the medication was dispensed prior to the specimen 

collection date.

Conclusion: The MRO made a determination regarding the validity of the prescription. In this 

case, the donor provided documentation consistent with the laboratory report of oxycodone. 

MRO Reported Result: Negative.

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and 

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.3, page 4-24; item 6.3, page 6-67. 
33

Case #26 Laboratory Reported Result: Positive for Codeine – 17 ng/mL and Morphine – 59

ng/mL

Verified Negative Drugs (Codeine, Morphine); Possible Safety Concerns

Laboratory Report: The laboratory sent an electronic report and an image of the completed

Federal CCF (Copy 1). The information on the electronic report matched the information on the 

Federal CCF. The Federal CCF was properly completed by the collector and the laboratory.

Discussion: During the interview with the donor, the donor states that while shoveling snow to 

go to work, he immediately experienced severe back pain. He says the pain was similar to what 

he experienced when he had a disc rupture five years ago. Because he had some pain 

medication left over from a root canal 13 months ago, and the expiration date of the medication 

had not passed, he took it for his pain. The medication was originally prescribed to be taken on 

an as-needed basis. He reports that the label said APAP #4 (codeine). He rested for the next 

three days, and because the pain medication was working, he did not seek medical attention. He 

subsequently felt better and went to work the day they were conducting drug testing. The donor

submits a copy of the prescription bottle showing the dentist’s name and date, which was, in fact, 

13 months prior to the drug test. The donor is unable to provide additional medical information. 

Conclusion: The donor has a valid prescription for the lawful possession of codeine that specifies 

no time limitations on the use of the drug (even if the expiration date on the dispensed 

prescription has expired). The prescription would justify the laboratory finding for codeine but 

not for morphine. Morphine, as a metabolite of codeine, would not be expected to be detected in 

oral fluid in concentrations greater than codeine. When there is no clinical evidence of abuse,

and the oral fluid concentration of morphine is less than 150 ng/mL, the MRO is required to

report the test result as Negative.

Additionally, the MRO does not find any clinical evidence of abuse of opiates.

Note: This case introduces the question of what the MRO should do in the case of safety 

concerns related to the presence of a drug reported as Positive by the laboratory but that is 

reported as Negative by the MRO.

The MRO Guidance Manual states that within the HHS program, the MRO is not required to 

discuss safety aspects of the donor’s job function. An MRO’s decision to contact an employer 

regarding safety issues related to a donor’s valid prescription (i.e., legal drug use) is subject to 

the MRO’s independent and voluntary choice and any obligations the MRO may have with the 

donor’s employing agency. Therefore, before discussing aspects of job safety with an agency, 

the MRO should review the terms of their service agreement with the agency and any agency 

policies or rules that govern issues related to safety and/or seek private legal counsel. HHS and 

SAMHSA take no position regarding whether an MRO’s independent decision to disclose safety 

related information (or other drug testing information, such as numerical values) in the context of 

a donor’s legal drug use is legal or appropriate in any given circumstance because this issue is 

outside the scope of the Mandatory Guidelines. Please refer to the MRO Guidance Manual, 

Chapter 6, Section 6.3, Occupational and Public Safety, regarding handling safety issues 

involving valid prescriptions.
34

MRO Reported Result: Negative. 

References:

HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs 

(January 1, 2020), item 4.5.3, page 4-24; item 5.4.1, page 5-26; item 6.3, page 6-67. 

Mandatory Guidelines for Federal Workplace Drug Testing Programs, 84 Fed. Reg. 57554

(October 25, 2019), Section 13.9.d.