Effective Date: October 1, 2017 Revised March 2018 Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs Department of Health and Human Services Substance Abuse and Mental Health Services Administration Center for Substance Abuse Prevention Division of Workplace Programs Rev. 0318 Note: This manual applies 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 Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (82 FR 7920) dated January 23, 2017 (effective October 1, 2017). This manual does not apply to specimens submitted for testing under U.S. Department of Transportation (DOT) Procedures for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR Part 40). This revision of the manual includes a reorganization of material in the manual. The current version of this manual and other information including MRO Case Studies are available on the Drug Testing page under Medical Review Officer (MRO) Resources on the SAMHSA Web site: https://www.samhsa.gov/workplace Previous versions of this manual are obsolete. Rev. 0318 MRO Guidance Manual: Summary of Changes DATE Change Page No. Rev. No. March 2018 3.1.1. Updated process for agency/laboratory to notify 3.1 Rev. 0318 HHS/NLCP of additional Schedule I or II drug test 4.5.3. Clarified MRO verification of prescriptions, March 2018 medical records, and other medical information to 4.19 to 4.21 Rev. 0318 determine whether a legitimate medical explanation exists for a positive drug test March 2018 5.1.3. Removed example of Vick's VapoInhaler as an OTC 5.1.3 Rev. 0318 product containing L-MAMP 6.3. Clarified guidance regarding an MRO’s decision to March 2018 discuss safety information related to a donor’s valid 6.6 Rev. 0318 prescription (i.e., legal drug use) with the donor’s agency March 2018 7.1.1.a. Removed example of Vick's VapoInhaler as an 7.2 Rev. 0318 OTC product containing L-MAMP March 2018 Table 4. Revised MRO action for a Rejected for Testing Tables - 7 Rev. 0318 specimen for consistency with the Mandatory Guidelines ii Rev. 0318 TABLE OF CONTENTS Chapter 1 Introduction ....................................................................................................... 1-1 1.1 The Federal Drug Testing Program ..................................................................... 1-1 1.2 The Medical Review Officer (MRO) ................................................................... 1-2 Chapter 2 The Federal Drug Testing Custody and Control Form...................................... 2-1 2.1 General Information ............................................................................................. 2-1 2.2 Use of an Electronic Federal CCF ....................................................................... 2-3 2.3 Federal CCF Content Requirements .................................................................... 2-4 2.3.1 Test Facility Identification ....................................................................... 2-4 2.3.2 Bottle Labels/Seals................................................................................... 2-4 2.3.3 Required Statements ................................................................................ 2-4 2.4 Federal CCF Distribution ..................................................................................... 2-5 2.4.1 Paper Federal CCF ................................................................................... 2-5 2.4.2 Federal ECCF........................................................................................... 2-6 2.5 Test Facility Report to MRO ............................................................................... 2-6 Chapter 3 Drug Testing ...................................................................................................... 3-1 3.1 Federal Workplace Drug Testing Overview ........................................................ 3-1 3.1.1 Drugs ........................................................................................................ 3-1 3.1.2 Specimen Collection ................................................................................ 3-2 3.1.3 Security and Chain of Custody ................................................................ 3-2 3.1.4 Specimen Validity .................................................................................... 3-3 3.1.5 Testing...................................................................................................... 3-3 3.2 Test Methods ........................................................................................................ 3-5 3.2.1 Initial Drug Tests ..................................................................................... 3-5 3.2.2 Confirmatory Drug Tests ......................................................................... 3-6 3.2.3 Specimen Validity Tests .......................................................................... 3-6 3.2.4 Split Specimen (Bottle B) Testing ........................................................... 3-7 iii Rev. 0318 3.3 IITF or Laboratory Reports .................................................................................. 3-7 3.4 Specimen and Records Storage ............................................................................ 3-8 3.5 Oral Fluid Testing ................................................................................................ 3-9 Chapter 4 MRO Review and Reporting Procedures .......................................................... 4-1 4.1 Administrative Review of Documents ................................................................. 4-1 4.1.1 MRO Copy of the Federal CCF (Copy 2) ................................................ 4-1 4.1.2 Test Facility Report—Federal CCF (Copy 1) and/or Computer- Generated Electronic Report .................................................................... 4-3 4.1.3 Federal CCF or Specimen Errors ............................................................. 4-6 4.1.4 Federal CCF Remarks .............................................................................. 4-9 4.1.5 Actions Based on Administrative Review ............................................. 4-10 4.1.6 Use of the 2017 and 2014 Federal CCFs ............................................... 4-12 4.2 Donor Interview ................................................................................................. 4-13 4.3 Handling of Multiple Results or Multiple Collections During the Same Testing Event ..................................................................................................... 4-15 4.4 Split Specimen Tests .......................................................................................... 4-16 4.5 Interpretation and Result Verification ............................................................... 4-17 4.5.1 IITF and Laboratory Results .................................................................. 4-18 4.5.2 Donor Explanation ................................................................................. 4-19 4.5.3 Prescriptions ........................................................................................... 4-19 4.5.4 State Initiatives and Laws ...................................................................... 4-21 4.5.5 Changing a Verified Test Result ............................................................ 4-22 4.6 Documentation and Recordkeeping ................................................................... 4-22 4.7 Reporting............................................................................................................ 4-23 4.8 Confidentiality ................................................................................................... 4-24 4.9 Discrepancies That May Require the MRO to Cancel a Test ............................ 4-24 Chapter 5 Interpretation of Results .................................................................................... 5-1 5.1 Amphetamines ..................................................................................................... 5-1 5.1.1 Enantiomers ............................................................................................. 5-2 iv Rev. 0318 5.1.2 Prescription Drug Products ...................................................................... 5-3 5.1.3 Non-prescription Drug Products .............................................................. 5-3 5.1.4 Designer Sympathomimetic Substances .................................................. 5-4 5.2 Cannabinoids........................................................................................................ 5-4 5.3 Cocaine ................................................................................................................ 5-5 5.4 Opioids ................................................................................................................. 5-5 5.4.1 Morphine and Codeine ............................................................................. 5-6 5.4.2 Oxycodone, Hydrocodone, Oxymorphone, Hydromorphone .................. 5-7 5.4.3 Poppy Seeds ............................................................................................. 5-8 5.4.4 6-Acetylmorphine Positive Specimens .................................................... 5-8 5.5 Phencyclidine ......................................................................................................