Prepared by Division of Workplace Programs, SAMHSA HHS 1 Where Is HHS Headed in 2000? Walter F. Vogl, Ph.D. Drug Testing Section Division of Workplace Programs CSAP/SAMHSA/HHS

Prepared by Division of Workplace Programs, SAMHSA HHS 2 Initiatives Draft Guidelines for Alternative Specimens and On-Site Testing –Includes Revising Guidelines for Urine –Draft Collection/MRO manuals New Federal Custody and Control Form Update the HHS Collection Handbook Update the MRO Manual Workplace Resource Center

Prepared by Division of Workplace Programs, SAMHSA HHS 3 Federal Custody and Control Form OMB Approval until July 31, 2000 Approval suggested review before renewal Two working group meetings Make the form “user friendly”

Prepared by Division of Workplace Programs, SAMHSA HHS 4 Major Changes to Revised CCF Split Specimen Copy eliminated Tamper-evident Labels Bottom of Copy 1 Simplified Chain of Custody Revised Outcomes for Lab Results Revised Collection Instructions Form Follows Sequence of Events –Easier for Collector to Complete

Prepared by Division of Workplace Programs, SAMHSA HHS 5 Format Changes Permitted Highlighting collector/donor fields (New) –Color must not prevent making clear photocopies Use line/combs/boxes for donor’s SSN (New) Copies 3 through 6 –Color Borders (New) Font Size/Style Variable (New)

Prepared by Division of Workplace Programs, SAMHSA HHS 6 Copy 1 - Laboratory Copy STEP 1 –Federal Agency Acronym (New) –Collection site information (Moved) STEP 2 –Single/Split/No specimen (New) –Observed Collection (New)

Prepared by Division of Workplace Programs, SAMHSA HHS 7 Copy 1 (continued) STEP 4 –Chain of Custody Statement (New) –One Collector Signature (New) –Accessioner at Lab completes Chain of Custody Notes Condition of Primary Seal (New) Releases Specimen Bottle(s) (New) Purpose of Change (Deleted)

Prepared by Division of Workplace Programs, SAMHSA HHS 8 Copy 1 (continued) STEP 5a - Primary Specimen Test Result – Revised Outcomes for Lab Results Rejected for Testing (New) Adulterated (New) Substituted (New) Invalid Result (New) STEP 5b -Split Specimen Test Result (New) –Lab Name & Address –Reconfirmed/Failed to Reconfirm –Certification Statement (New)

Prepared by Division of Workplace Programs, SAMHSA HHS 9 Copy 2 -Laboratory Copy MRO Determinations – Replace STEP 5b & Labels STEP 6 - MRO Determination - Primary Specimen –Refusal to Test (New) STEP 7 - MRO Determination - Split Specimen –Reconfirmed/Failed to Reconfirm (New)

Prepared by Division of Workplace Programs, SAMHSA HHS 10 Public Comments 26 Separate Submissions 17 Like the Proposed Form Most Suggested Changes –Did Give Reasons

Prepared by Division of Workplace Programs, SAMHSA HHS 11 Examples of Comments Delete Agency Acronym List “Pre-employment” before “Random” Collection “Location” or “Business” Address List “Split” before “Single” 2 Lines for “Remarks”

Prepared by Division of Workplace Programs, SAMHSA HHS 12 Comments (continued) “More” Space Eliminate “Delivery Service” box Switch Copy Sequence –Collector 4; Employer 5; Donor 6 Retain Color Copies

Prepared by Division of Workplace Programs, SAMHSA HHS 13 Comments (continued) Modify Certification Statements Permit Placement Marks for Scanning Eliminate Dashes for SSN Leave Labels on Side 1 to 2 Year Phase in Period

Prepared by Division of Workplace Programs, SAMHSA HHS 14 Implementation New CCF – Available August 1, 2000 Current CCF –Permit Use for Period of Time – Lab Must Not Reject Specimen