Michele Herman

Thanks for your replies. I posed this question to CAP and their reply was in line with your response above in that this standard (com.30450) is relevant to the fetal blood screen kits which contain controls. Do you have an external control material that you are using to compare lots for the FMH kits? We have thought of using patient specimens, but we rarely encounter a positive patient.

How are people checking new blood bank reagent lots and shipments to satisfy CAP standard com.30450 "New reagent lots and shipments are checked against old reagent lots or with suitable reference material before or concurrently with being placed in service." What kinds of samples are you using? Is anyone using patient samples or external QC materials?

Our facility is struggling with how to deal with anticoagulant volumes when preparing neonatal aliquots from apheresis products. Are any facilities performing manual calculations for this? Does your LIS software perform the calculation?

Our facility currently documents donor consent (with donor signature) on our therapeutic plebotomy form. This is the statement we use "I consent to the withdrawal, as directed by my physician, of approximately 500 mL of my blood. I consent to the use or disposal of my blood in any manner deemed appropriate by my physician or the physician in the blood bank." Guess we will re-examine if this statement is adequate in light of new requirement.

We also reconstitute factor concentrates in bloodbank and issue in syringe. My interpretation is that rule 201.25 does not apply to us. See below from June 2005 draft guidance. I would love it if someone could confirm my interpretation. Q6: Does the bar code rule require hospitals to affix bar codes on drugs? A6: No. The rule applies to drug manufacturers, repackers, relabelers, and private label distributors who are subject to the establishment registration requirements under the Act. Hospitals, clinics, and public health agencies that only "maintain establishments in conformance with any applicable laws regulating the practice of pharmacy or medicine and that regularly engage in dispensing prescription drugs . . . upon prescription of practitioners licensed by law to administer these drugs to patients under their professional care" are exempt from the establishment registration requirements (21 CFR 207.10() and, by extension, are exempt from the bar code rule (response to comment 2, 69 FR 9120 at 9123).