XYZ Lab FDA Manual/Labeling of frozen specimensAdopted 5/05

Labeling instructions for sperm, oocytes and embryos

Name of Lab,

Address of Lab

Introduction

Gametes and embryos that are stored frozen in the IVF laboratory must be labeled appropriately according to FDA regulations (21CFR 1271). Please use the following labeling system to label the tissues.

Label / Use for the following tissue
Label #1: Pastel Blue label (Avery Label 5980)
NOT EVALUATED FOR INFECTIOUS SUBSTANCES.
WARNING: Advise patient of communicable disease risks / Gamete source(s) not tested
Label #2: Pastel Blue label (Avery Label 5980)
NOT EVALUATED for INFECTIOUS SUBSTANCES.
TESTED DONOR/UNTESTED PARTNER
WARNING: Advise patient of communicable disease risks / One gamete source not tested, but the other fully screened and eligible.
Label #3: Green label (Avery Label 5979)
ELIGIBLE DONOR EMBRYOS
MEETS ALL SCREENING/TESTING REQUIREMENTS / Gamete source(s) meet all screening and testing requirements and are deemed eligible.
Label #4: White label (Avery Label 5160)
INFECTIOUS DISEASE TESTS PENDING
WARNING: DO NOT RELEASE / Eligibility determination incomplete pending test results.
Label #5 and 6: Neon Yellow labels (Avery Label 5979)
WARNING:
DONOR AT RISK for ______
WARNING: Advise Patient of Communicable Disease Risks
OR
WARNING:
DONOR at RISK for RELEVANT INFECTIOUS DISEASES
WARNING: Advise Patient of Communicable Disease Risks / Donor is ineligible because he/she has a risk factor for one or more of the relevant infectious diseases.
Label / Use for the following tissue
Label #7 and 8: Neon Pink labels (Avery Label 5979)
WARNING: REACTIVE TEST RESULT for ______
WARNING: Advise patient of
Communicable Disease Risks

OR

WARNING: REACTIVE TEST RESULT for ______
WARNING: FOR NON-CLINICAL USE ONLY / Abnormal infectious disease test result.

Notes:

  1. The label should be affixed to the goblet in which the tissue is stored and/or to the paperwork that accompanies the specimen.
  2. A biohazard label should be additionally attached to any specimen that tests positive for any infectious disease.
  3. Specimens that are frozen with test results pending need to be stored in the quarantine tank until the testing is complete and the tissue is deemed eligible.
  4. Specimens that are frozen for non-clinical use (label #8) or that test positive for a communicable disease (label #7) also need to be stored permanently in quarantine.
  5. For specimens stored in goblets, the metal ID tag at the top of the goblet should be in the same color as the labels above.
  6. For specimens stored in vials, the vial cap should have a color insert that matches the label color.
  7. When placing specimens in quarantine, don’t forget to add them to the quarantine log.

Approval Date and Schedule for Review

Approved by (Laboratory Director):

Approval Date:

Next Scheduled

Review Date:

Review Authority: Laboratory Director or Assistant Director

Review/Date:

Written by/Date John Doe/ May 25th 2005Version: 52505-1

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