Where Is HHS Headed in 2000?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Where Is HHS Headed in 2000?