Platelet Bacterial Testing

[butlermom]

A sales rep has informed us that the FDA is recommending "day of transfusion" bacterial testing for plateletpheresis units. This would place the burden on the transfusion service to perform the testing, and is in addition to the 24-hour culture done by the blood supplier. Supposedly, even though there may be bacteria in the unit, there may not be bacteria prevalent in the sample used for the culture because there are not enough bacteria in the whole unit yet. By testing a sample on the day of transfusion, more time has passed allowing more bacteria to grow and therefore a greater likelihood of detection. There is a nice little kit to perform this testing and it is fairly quick and easy. Again, this is not mandated, YET, but apparently the FDA and AABB are discussing it. Has anyone else heard of this?

[MAGNUM]

No, I havent heard this yet, but thanks for the heads up.

[Moncada]

To my knowledge, the FDA and AABB do not have an official view about this "yet", but the test is called Verax Platelet PGD Test. The salesman was also in our facility. While in theory, this may increase the comfort level of platelet transfusion, in reality it would be crippling to our facility's operation. We often transfuse 35+ pheresis daily, many dispensed urgently to trauma and OR. The test takes approximately 30 minutes to complete on each one; time that both the patient and the tech, unfortunately don't have.

Even with the large volume of pheresis that we transfuse annually, we have only had one case of contaminated platelets being transfused, and that was prior to the 24 hour testing performed by our supplier. It is hard to justify the added cost and lag time based on at least our statistics.

Unfortunately, it would take either a sentinel event or a regulatory requirement for this to make any sense at our facility.

[Kashmira patel]

News letter from AABB dated May 4 2012 volume 18 has the FDA's final rule on Amendments to sterility test requirements for biological products. Also AABB is conducting a membership survey for the current measures to detect bacterial contamination in platelets. My understanding from this is, if your blood supplier is performing the sterility test for apheresis platelets, it is not a regulatory requirement for a transfusion service to repeat the bacterial testing. Also if you are a member of UHC list serve there is a nice survey results posted for bacterial testing of platelets.

[h=1][/h]

[Annadele]

We were able to use the Verax PGD Test to extend the expiration time of an expiring platelet by four hours. Since our bone marrow transplant patients often have platelets ordered just after midnight, this often means the difference between "wasting" a platelet and using it and helps preserve our inventory when low.

Annadele

To my knowledge, the FDA and AABB do not have an official view about this "yet", but the test is called Verax Platelet PGD Test. The salesman was also in our facility. While in theory, this may increase the comfort level of platelet transfusion, in reality it would be crippling to our facility's operation. We often transfuse 35+ pheresis daily, many dispensed urgently to trauma and OR. The test takes approximately 30 minutes to complete on each one; time that both the patient and the tech, unfortunately don't have.

Even with the large volume of pheresis that we transfuse annually, we have only had one case of contaminated platelets being transfused, and that was prior to the 24 hour testing performed by our supplier. It is hard to justify the added cost and lag time based on at least our statistics.

Unfortunately, it would take either a sentinel event or a regulatory requirement for this to make any sense at our facility.

[Liz]

We were able to use the Verax PGD Test to extend the expiration time of an expiring platelet by four hours. Since our bone marrow transplant patients often have platelets ordered just after midnight, this often means the difference between "wasting" a platelet and using it and helps preserve our inventory when low.

Annadele

Great, do you have a reference please.

[dgibaud]

There was a study published in TRANSFUSION concerning "day of use" testing w/Verax PGD test. They found 9 of 27,620 platelet doses positive "at issue" that were released by donor centers as culture negative. Some of the patients receiving the PGD positive units did have significant reactions. They extrapolated their data to suggest that, if use was required in the US, we could prevent more than 300 transfusion reactions and several fatalities per year.

The article title is:Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test.

[Liz]

There was a study published in TRANSFUSION concerning "day of use" testing w/Verax PGD test. They found 9 of 27,620 platelet doses positive "at issue" that were released by donor centers as culture negative. Some of the patients receiving the PGD positive units did have significant reactions. They extrapolated their data to suggest that, if use was required in the US, we could prevent more than 300 transfusion reactions and several fatalities per year.

The article title is:Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test.

Just pulled it out, thank you I appreciate it.

[Eman]

We were able to use the Verax PGD Test to extend the expiration time of an expiring platelet by four hours. Since our bone marrow transplant patients often have platelets ordered just after midnight, this often means the difference between "wasting" a platelet and using it and helps preserve our inventory when low.

Annadele

Hi, short time lurker, first time poster, long time QA type. I'm really curious how this practice is justified from a QA point of view. Are you modifying the expiration date on the product itself? Did you submit a variance request to the FDA? Is the SDP considered issued after you Verax it, and even if so, wouldn't the floor send it back because it appears to have expired a couple hours earlier (at midnight?)

Don't get me wrong, your practice seems rather reasonable and logical, but I'm not sure how it fits with current US regulations and standards. And I'd like to know, so we could look into doing it too.

Thanks!

Erik