On June 24th, the following question was posed to the CBBS e-network:

How many blood donor centers in California, especially Southern California, are doing nucleic acid testing (NAT) on a routine basis. Our hospital collects its own donors, and we are getting resistance from our Administration to adding this cost until the FDA mandates it.

A multitude of replies were received in response to this question. Here is a sampling of those replies.

1. NAT testing has become the standard of care. If a facility chooses to transfuse without available testing there should be a very good reason such as unavailability of the assay with documentation of a reasonable effort to acquire testing from known providers.

2. We are one of the donor centers doing NAT testing. In fact, I believe that anyone collecting blood for transfusion and not doing NAT testing is clearly 3 or 4 standard deviations from the standard of practice. This administrator needs to speak with his or her risk managers as soon as possible.

3. A large blood center in Sacramento has been performing NAT testing on nearly100% of their allogeneic collections since early 1999. They started with HCV only, but now are testing pooled specimens for both HCV and HIV. Their client hospitals have accepted the additional, NAT- related fees without much argument. That center is considering adding testing for HBV DNA by the end of the year. They also test for a blood center in Alaska and for another California Blood Bank. Since this center does NAT testing for other centers and has offered to test for any blood drawing facility, it would be difficult to defend a case of HCV or HIV infection due to a window period infection simply because NAT was not yet "FDA-mandated" or licensed. The FDA has actively encouraged NAT and is supporting licensure by the companies, plus bending its own rules regarding permitting statements about components and derivatives being "NAT tested". The administration may resist but ask them to check with their risk management department about paying the costs of recovery for NAT testing to ensure the blood supply is a little safer, versus what a lawsuit would cost.

4. All California Red Cross donors, except autologous, are NAT tested. If a donor refuses the test, he/she is not accepted.

5. Central California Blood Center (Fresno) has been doing NAT testing routinely since August of 1999. No units are released into inventory until results of NAT is known.

6. All UBS and affiliated centers have routinely been performing NAT testing since April 1999. UBS leadership can't believe ANY institution would be brave or foolhardy enough to still NOT be having their blood tested more than a year later......Were these people awake during the AIDS crisis? Haven't they read about the cases of HIV and HCV that have been caught using NAT that were negative on all the screening tests?

7. NAT testing is done on all but autologous donors at Blood Centers of the Pacific in San Francisco.

8. It is important to consider a standard of care in transfusion medicine when electing not to perform NAT testing. Although NAT is not FDA mandated, the fact that almost all of the blood in the nation is being tested using NAT (98% +) indeed sets a standard of care. For those that argue an investigational test cannot set a standard of care they need to remember threethings:

1. The litigation surrounding HIV in the early 1980s. Clearly an FDA mandate is a separate issue from standard of care.
2. At some point in the future a judge or jury will decide what the standard of care is. They will look at how many centers were performing the testing & why. They will look at what was known about the test (like it has prevented many cases of hepatitis C already and has detected HIV as well).
3. Whining about the financial aspects of the testing will not help in court. SO... It is fine to elect not to do NAT testing, however if you are unlucky and a recipient contracts HIV or hepatitis C - JUST OPEN YOUR WALLET!

9. We are a small blood bank (5,000 units/year) in the Central Valley and have the NAT testing done on a routine basis. Although this is not an FDA mandated test, we found that the majority of our surrounding blood banks were doing the NAT testing and felt, for standard of care and legal implications, we should comply.

10. I can speak for my previous employer's two hospitals (one is medium-sized, the other small) who collect about 3,000 donations between them. We had implemented NAT testing in August of last year. Interestingly, we did get one long time donor who came up HCV NAT positive and was EIA negative. I don't know what the donor's status is now, but it sure made me feel better about doing it at the time. We had approached the decision from the standpoint that we wouldn't want to be in the position of defending a transfusion transmitted disease if there were something additional that was easily obtainable that could have prevented it. This viewpoint was presented to the hospitals transfusion committee and overwhelmingly approved.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator