09-2013 Case of the Month

What would you do in this this case?

Assisted reproductive technology programs must maintain compliance with US Food and Drug Administration (FDA) regulations.

Following an inspection of your clinic’s donor program, which of the following would result in an FDA action? 

A. The disease-testing lab is utilizing NAT testing for HIV.
B. The disease-testing lab is utilizing total antibody screening tests to test for Hepatitis-B Core.
C. There has not been a satisfactory response to a 483 issuance.
D. The lab has been following the clinic’s standard operating procedures (SOPs).
E.  The lab has been providing documentation for donation(s) proving the clinic SOPs have been followed.

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Answer A is incorrect: HIV NAT testing is the current standard for eligibility testing.

Answer B is incorrect: Total antibody is the standard test requirement. It should be noted that some test kits for NAT testing of HIV also include Hepatitis NAT. But the requirement for Hepatitis B is total antibody.

Answer C is CORRECT: There has not been a satisfactory response to a 483 issuance. If a response to issuance of a 483 is required, lack of one may lead to more serious repercussions such as a warning letter or potentially a cease manufacturing order.  

Answer D is incorrect: Following clinic SOPs is a requirement and any deviation from this should be documented.

Answer E is incorrect: Documentation that all procedures have been followed by the lab as well as clinic personnel for all aspects of eligibility determination, labeling and storage is appropriate.

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