Bench mark for number or % of recalls/lookbacks from blood suppliers for use in Supplier Qualifications.

[conwaysbb]

We have changed our hospital accreditation form the JCAHO to DNV. One of the inspectors asked me during the DNV inspection whether I evaluated my blood suppliers on the number of recalls and/or lookbacks recieved from them during the year as part of the Supplier Qualifications (they follow ISO standards).

I am bringing this issue here as I have no idea if anyone has a benchmark for the number or percentage of recalls/lookbacks recieved from a blood supplier. Alhtough I know that there have been several additional reasons added because of deferral requirements, most of the recalls I get are because of incomplete medical evaluations or errors in manufacturing, and would certainly be a valid issue to be looked at when performing annual supplier qualifications. Of course, I will be asked where I got my information for the bench marking.

Would anyone know if this issue has been bechmarked any where this information can be assessed? Does anyone hava na opinion on this? If so are you a Transfusion Service/Blood Bank or a Blood Supplier?

Just for comparison, I have a hospital based donor room which supplied us with 1800 units last year we issued unfortunately 2 recalls for a recall/lookback rate of .11%. However, with a total of 10, 000 received from my blood suppliers I received a total of 42 recalls and 1 lookback resulting in a recall/lookback rate of 0.40%.

Thanking you in advance for your thoughts and direction.

[Bill]

Why not just move forward and state in your P&P that as long as the lookbacks and recalls do not increase by more than 5% from previous year, then you consider them OK. If they increase more than that 5%, then you will discuss the situation with the supplier and make future decisions accordingly.

[AMcCord]

The recall reasons you listed - manufacturing errors and medical evaluation problems - would be very valid points of consideration. They could definitely be indicators of quality problems. I agree with Bill that looking for upperward trends would be meaningful.

The whole concept of supplier qualifications for blood products is difficult for me - there is only one realistic option for blood in our area. That said, thankfully our supplier does a very good job.

[tbostock]

We're a transfusion service. Our recall rate was 0.2% for 2010. As far as I know, I have never seen any type of published benchmark.

I agree with A McCord that you usually only have 1 or 2 blood suppliers to choose from, and the decision is usually based heavily on price and availability of products, not their recall rate. As said above, I would watch for a significant increase.

[conwaysbb]

Fortunately for us, I have access to at least 4 blood centers that want my business. Hospitals around our area (Northern NJ) change Blood Suppliers based upon "What can do for us now". Definitely pricing is the major issue, especially because of the high cost of living, which results in a high cost for blood and components in our area. Because of this, the blood centers are becoming very competitive in their pricing, so I have been able to reduce my costs/unit on several blood components. I also need to have at least one extra blood supplier for my needs, as there are also a ton of hospitals vying for blood products.

As DNV follows ISO standards and Supplier Qualification is a big part of the ISO standards, I need to develop some quality indicators to determine how well my supliers are doing, with lookback and recalls being suggested by our inspector.

Knowing that changes in deferrals have constantly been increasing, I would agree that determining a baseline % of recalls/lookbacks and then stipulating that the recall rate should not increase more than a certain % would be an appropriate practice and 5% is reasonable.

Thanks for the comments.