HLA: REQUIREMENTS FOR COLLECTION

The Clinical Laboratory Improvement Amendment of 1988 (CLIA ’88) establishes sample labeling requirements. As well, CLIA accredited laboratories must identify sample collection and shipment requirements and notify submitting facilities. The following instructions will provide guidance to comply with CLIA ’88 regulations.

Sample labeling instruction:

  1. Individual’s correct name, first and last. Make sure all tubes have correct, identical and legible name spelling.
  2. Hospital identification number.
  3. Date of collection.
  4. Phlebotomist’s initials or signature.

Written Test Authorization for All Samples to be Tested for Clinical Purposes

  1. Written authorization is documented on the Histocompatibility Requisition Form (BS 320H). See www.bloodsystemslaboratories.org.
  2. If a BS 320H is not received with the sample, the laboratory will fax client a Test Authorization Form for signature by an authorized individual.

Minimum Sample Collection and Storage Requirements for CHILDREN:

  • HLA Typing
    1. Infant (<1 year): 3 mL EDTA (purple top) anticoagulated whole blood.
    2. Child (1 year-10 years): 5 mL EDTA.
    3. Child (>10 years): 10 mL EDTA.
    4. Contact the HLA Laboratory when the WBC count is <4000/µL for required sample amount.
    5. Samples may be refrigerated (4°C) or stored at room temperature.

Sample Collection and Storage Requirements for ADULTS:

  • HLA Typing
    1. Specimen: Collect 20 mL EDTA, mix thoroughly. When Class I and Class II are requested 20 mL EDTA will be sufficient.
      • Collect 40 - 60 mL EDTA when the WBC count is <4000/µL
    2. Storage temperature: Refrigerated (4°C) or room temperature.
  • HLA Single Locus (example: B27 typing or DQ2 and/or DQ8 typing)
    1. Specimen: Collect 5 mL EDTA, mix thoroughly.
    2. Storage temperature: Refrigerated (4°C) or room temperature.

    Note: ACD may be substituted for EDTA anticoagulated samples for DNA molecular testing.

  • Antibody Screen
    1. Specimen: Collect 10 mL whole blood in a clot tube (red top). Store and transport at 4°C. If not shipped within 48 hours of collection, separate and freeze serum. Send on ice.
  • HLA Crossmatch
    1. Recipient Specimen: Collect 10 mL whole blood in a clot tube (red top). Store and transport at 4°C. If not sent with in 48 hours of collection, separate and freeze the serum. Send on ice.
    2. Donor Specimen: Collect 30 mL ACD (yellow top) anticoagulated whole blood: Store and transport at room temperature.

Packing and Shipping Information

  1. Place specimens and paperwork into the double box sample mailer. Place inner box into ziplock bag.
    1. Complete the Histocompatibility Laboratory Requisition Form (BS 320H), available from your local blood center representative.
  2. Transport blood specimens as soon as possible to be received by the HLA lab within 48 hours from sample collection.
    1. Federal Express for overnight standard delivery Contact the HLA laboratory to arrange Saturday deliveries.
    2. Greater Phoenix area sample pick-up: call the HLA Laboratory at 1-866-342-4275, extension 7034.
    3. Ship specimens to:

      Blood Systems Laboratories
      Histocompatibility Laboratory
      2424 West Erie Drive
      Tempe, AZ 85282
      1-866-342-4275, ext. 7034