The following question was posed to the Web Master (me), and I wish to share it with the network, since the answer is somewhat interesting.

Here is the question: If there are multiple racks of blood bank reagents (same lot number in each rack) in the blood bank, is QC required to be performed on each rack?

In order to answer this question, I contacted the AABB National Office, and obtained the following information from Leane Ziebell Director, QA.

And here is what Leane had to say:

Dr. Shulman: I'll be answering from the perspective of each accrediting and regulatory agency, as best I can derive from their requirements.

FDA: 21 CFR 606.65 (c) "Representative samples of each lot of the following reagents or solutions shall be tested on a regularly scheduled basis by methods described in the SOP Manual... "

HCFA: 42 CFR 493.1205 does not address testing detail related to reagents.

AABB: A5.130 just discusses a program of quality control that is comprehensive enough to ensure reagents function as expected.

Based upon these three references, I would respond by referring to FDA's terminology - "representative sample of each lot" - which would mean to me that if the same lot is currently in use in all racks, testing one rack would be sufficient. However, there must be a process for checking that all racks have only one lot. If not, the second lot must also be tested to assure the reagents are functioning as expected that day.

1. At the LAC+USC Medical Center, we have multiple technical work stations within the transfusion service. At these work stations are racks containing the typical blood bank reagents (anti-A, anti-B, A1 cells, B cells, anti-D, etc), and the same lot of each kind of reagent is currently in use in all racks. Thus, according to the above discussion, we test the reagents in one rack (not each rack) each day of use. In order to minimize missing a reagent failure, we perform this QC testing on a rotational basis.

ADDENDA June 24, 2000

2. Another Perspective (2 hospitals - one large and busy, one smaller): The regs and standards allow for flexibility in implementation, which is a good and useful thing. But there is another influencing factor which has caused us to QC every rack on every shift (in other words, do a whole lot more serological work than I would prefer). That factor is the use of rotating staff who are less experienced overall but esp in BB. Due to cutbacks and absolute minimum staff in every dept. but esp BB we have been forced to train people who do not want to work in BB, feel a deep anxiety when they work in the dept., and even when well-trained themselves, do not have a group of supportive blood bankers to back them up if and when they run into problems. For this reason I have found it more efficient to QC each rack each shift. When problems arise, the reagents needing scrutiny are narrowed to one rack (unless of course they have dipped into reagents from another rack, in which case, I can be assured that that rack has also been QC'd).

3. It was my understanding that the QC process would detect not only deterioration of a reagent lot, but also deterioration of any given vial due to contamination, high temperature deactivation, or even dilution (people can be strange!). Anyway, I have personal experience where a vial of anti-D didn't do its job, and its lot-mate in another rack passed QC.

4. A number of years ago the AABB inspector cited us for not testing each rack of reagents. The reagents were the same lot number. Good, now I can once again go back to testing just one rack!

5. I would concur with the interpretation of the regs, however, each day the racks should be checked and documented that all reagents in rack are of the same lot number and that visually all reagents are intact, ie no visible signs of contamination, discoloration, etc. This check should be documented. Additionally there needs to be a system that assures that a different rack is QCed on a daily basis. Additionally how is the user / tech QCed?

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