STD Policy

 For PDF and JPG image copies of the latest STD tests, see: http://trentdonor.org/std

STD Testing Policy and Procedures 

1. STD testing is performed approximately every 6 months. 

2. A contract is maintained with Private MD Labs which subcontracts to Viromed, a division of LabCorp, Inc for STD testing.

3. The test is arranged by contacting PrivateMD at 877-283-7882.  Account information is:  trent@trentdonor.org.
   The test may be ordered online from Private MD Labs by clicking on the following link:

   http://www.privatemdlabs.com/lab_tests.php?view=search_results&show=1641&category=21&search=fda#1641

   Request test # 139062 (FDA Guidance Male No Reflex) consisting of:
   a. 138874, HBsAg
   b. 138699, HBcore Total
   c. 138907, HCV
   d. 138948, HIV-1/HIV-2 plus O
   e. 138726, RPR with reflex to FTA
   f. 138922, HTLV I/II
   g. 138662, CMV Total
   h. 138828, CT/NG NAA
   i. 138687, HIV-1/HCV NAT

4. The price of the test panel is $1,700.00 and is paid via Trent's credit card.  The account has a 15% discount.
    
5. Once the test is in LabCorp's system, schedule appointment with Fremont LabCorp Patient Service Center (PSC).  Contact information is:
   LABCORP
   2147 MOWRY AVE STE C1
   FREMONT, CA 94538
   Testing hours: 8:00A-11:00A
   Phone: 510-793-3385
   Fax: 510-793-3597 
   Alternatively, Online Appointment URL:
   https://www.labcorp.com/wps/portal/patient/appointment
    
6. Arrive at Fremont LabCorp PSC during testing hours.  Fasting is not necessary however the lab requires that patient have not urinated for at least 1 hour before providing specimen.
    
7. Once specimens are drawn, the LabCorp PSC will overnight FedEx the specimen to Viromed's lab in a kit that is supplied by the lab.
    
8. Results are typically available after 3 days.  Request that LabCorp fax or e-mail the results to TrentDonor e-mail account.
    
9. Once results are available in electronic form, publish the results to the TrentDonor website under the /std section.  Results are not altered in any way.
    
10. Complete the written lifestyle questionaire and post any changes at http://trentdonor.org/screening.
     
11. A physical exam by a physician including inspection for evidence of STDs is completed.  Results posted at http://trentdonor.org/std.
     
12. STD results that are positive or inconclusive: Donations are stopped and follow-up of above testing conducted within 7 days. Donations to be stopped permanently for any STD positive result.
     
13. All records to above are to be kept for 10 years on the trentdonor.org web site in digital format.
     

The FDA website describing approved Donor testing is:

• Testing HCT/P Donors: Specific Requirements:
  http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm151757.htm 
   
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays:
  ^{http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm} 
  
   
• Code of Federal Regulations Title 21
  PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
  Subpart C--Donor Eligibility  Sec. 1271.85 What donor testing is required for different types of cells and tissues?https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=1271.85

   

• Purpose:
  ^{http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073964.htm#DONORSCREENING1271.75}
  In accordance with § 1271.47, you must establish and maintain standard operating procedures to assure that receipt and review of relevant medical records are properly conducted. In addition, for medical records created for the purpose of assisting in determining donor eligibility, such as records of the donor medical history interview and the report of a physical assessment of a cadaveric donor, you must establish and maintain SOPs to assure that such records are current, complete, and reliable.