Blood Suppllier auditing us?!?!?! FDA required??

[EMB4879]

Ok, our blood supplier does perform annual audits to ensure we are maintaining the products, keeping their purity and quality...but where do you draw the line? I see where some information is required since products are moved around, but having a Massive Transfusion Protocol (which we do), no me is NOT their business. We are AABB, CAP, CLIA accredited, no problems with Joint Commission or FDA (when we were licensed), so what right do they have to need this information. :mad: The Contract we just renewed and nothing really specific about it, mainly about storage and pertinent testing records/process, but now they are requiring more and more (in addition all referring to the standards and CAP requirements). They say it is to fulfill their FDA requirements.....is this really true or should I call them out?

Any input/info/suggestions please give...I have until Oct to argue, and believe me I will

[Eagle Eye]

First of all, why do they perform audit of your facility? DO you have depot/store their products and transfer to other facilities?

If yes and they want to make sure you are storing products appropriately, then I guess they can audit. I do not have experience with this.

But I would say that they have nothing to do with your Massive transfusion protocol.

[Liz]

To be able to provide during your emergency needs CAP requires this knowledge for the supplier.

TRM.30850 Adequate Blood/Tissue Supply Phase II

There is an agreement or understanding between the transfusion service and its blood/tissuesupplier(s) to ensure an adequate and safe blood/tissue supply.

NOTE: This agreement should include the means for maintaining inventory, requirements fornotification when a donor or components are found to be seropositive, and redistribution ofcomponents for disaster or emergency need, which could include obtaining needed componentsby drawing donors or by agreement with another facility. For services provided by an outside blood center (e.g. provision of blood and blood products, referral laboratory support, donor testing), a hospital must have an agreement approved by the transfusion service medical director and hospital administration. Information regarding means of immediate communication to the blood supplier (e.g. phone numbers) must be readily available to laboratory staff.

Evidence of Compliance: ✓ Copy of approved agreement (e.g. contract) with blood/tissue supplier(s)

REFERENCES

1) Sazama K. The changing relationships in transfusion medicine. Arch Pathol Lab Med. 1999;123:668-671

[heathervaught]

Any facility that returns blood products to the blood center is now considered a "supplier" to that blood center and therefore must be qualified. How the blood center chooses to do that is at their discretion. They do have a vested interested in determining what your massive transfusion protocol is - it impacts the blood center's collection goals and targets and their ability to meet your needs for the duration of your contract. You would be surprised at the number of facilities that are still just now rolling out MTPs, or expanding them to new departments (i.e. from ED to L&D). These potential changes in blood product consumption are not always communicated back to the blood center, which in the end could mean that a patient who really needs blood doesn't have it.

[DPruden]

The other reason they may want to see your Massive Transfusion policy is the distribution of O negative RBCs. Some institutions don't have an allowance to switch male MTP patients to O positive RBCs, which is pretty standard practice in trauma facilities.We also have a sticker that we date/initial before shipping or transferring units and attach to our shipping documents that states: Units have been stored at FDA/AABB approved temperatures. Units have been visually inspected & are acceptable. That was part of the requirement to be able to return or transfer products.

[EMB4879]

We have had the policy for quite some time, have an agreement with the center including par levels, and have policy for switching Rh neg to Rh pos. We are a trauma center, perinatal center, even the designated disaster hospital in this region. This is not anything new with our supplier. They have always done an audit, but are getting more and more pickier on what they want (though nothing has changed). Anything that has to do with quality and purity of the product I understand. I even called the FDA and they agree our MTP does not qualify as something that is needed. We have passed our last three AABB and CAP without any deficiencies. I have gone through the CFR and there are somethings I can see, but they do NOT perform these tasks for us and therefor I do not believe they require this. This is not a new game to us, we are not a smaller hospital, and we are all know were to find what AABB, CAP, TJC, and FDA require. Sorry had to vent.....