FDA Inspector

[jtsbbtalk]

Hello from New Jersey,

Our NJ Blood Banking group has often hosted FDA speakers. They stressed that while their inspections tend to be focused on Donor Centers or other facilities that are involved in processing of blood in some way, they can and do inspect transfusion services who do no processing or irradiating. Other Blood Bank Supervisors often argued this point with me...until the FDA started showing up at some NJ hospitals and word got out.

[Brenda K Hutson]

Right; so if you wash, irradiate and/or leukoreduce, the FDA will be visiting you.

If you don't perform any of those tasks, they can still visit you. One thing that my elicit such an Inspection would be disconcerting and/or numerous BPDs (and I don't say that at all to discourage documenting those; just a thought).

Brenda Hutson, CLS(ASCP)SBB:)

[L106]

Our NJ Blood Banking group has often hosted FDA speakers.

jtsbbtalk,

That's a really good idea, inviting FDA inspectors to speak at laboratory/blood bank professional meetings or seminars. It would be a terrific opportunity to ask them questions, clarifications, etc., and I'm sure that the FDA inspectors would learn a few things about "blood banking in the real world."

[jtsbbtalk]

Our supervisor's loved it. We also would have sessions with our state inspectors and even had one of AABB's on-staff assessors come in. It's great for the people who can't get out to the annual AABB meeting.

Our NJ website is www.njsbbp.org but it's under construction right now. It should have more soon. Our old site is www.njsbbp1.org and you can see some of the programs we've had recently.

[Sheila]

Did the inspector issue a Form 482 (Notice of Inspection)? If not, then you weren't really "inspected". They do have the authority to walk into any place dealing with regulated products, but not necessarily to inspect. Since there was a specific request for performance reviews, and the odd ball question about exterminators, they may have been following up on a "whistle blower" type report that had to do with a related situation?

m

Yes, he handed me that form at the very beginning. FDA has always inspected VA facilities; even those that do no on-site product modifications.

But I had the same thoughts about the exterminator question; I'm wondering if somewhere out there a bunch of blood bags were contaminated with insects or something.

[Townsend]

What do you know..... I was reading this posting on Wednesday evening, and who should appear at our door on Thursday morning? That's right, the FDA. We, however, had a very pleasent experience with our investigator. We are a children's hospital Transfusion Service who is FDA registered because of the manipulations that we perform. We do not do any blood collections, so her visit was only about 3 hours long. She was also very knowledgeable (used to work at a donor center - blood preparation) which helped speed up the process. If only all of our inspections were this easy - good luck to all of you when your time comes!

Stephanie

[Candan]

An FDA inspector (in a military unifom) spent 3 very long days last week inspecting my Blood Bank. She was rude and disrespectful. She was a nurse and did not have much working knowledge of the field.

Some of the things she "sited "were anything "handwritten" even if it was initialed and dated, lack of a procedure on how to take the daily temperatures even though the ranges were on the log sheet, a freezer alarm high set point was -20 C and the freezer alarmed at -19.9 and I could go on and on. She wanted copies of everything she didin't like. She even wanted copies of entire maufacturers equipment manuals.

The only reason we get inspected by the FDA is that our radiation oncology departemnt irradiates about 12 units a year for us. She spent about 20 minutes in oncology (out of 3 days) and did not site a single "Crossout", etc. I plan to have our Blood Center do our irradiation in the future and therefore to avoid this abuse.

I have never had a single CAP citation. Everything she tediously looked at and lectured me about repeatedly.

Large hospitals in my area and our Blood Center have also experienced the same issues recently, but we all had different inspectors. This was some consolation to me. Are they trained to act in such an unprofessional manner or what?

I guess I am done venting!!!:bonk:

I am getting inspected today and unfortunely tommorrow , it sounds like the same inspector you had. We were AABB and CAP inspected last year and had none of the grief she gave us today, I fear tommorrow. It could be a nightmare, HOWEVER I KNOW WE NEVER HARMED A PATIENT, WHAT SHE IS ASKING FOR IS OUTRAGOUS.

I guess i am done venting thanks

:cries:

[Mary**]

:eek:My thoughts are with you. It might be best if you didin't mention CAP or AABB. When I did it made it worse!

[L106]

Hang in there, Candan. Just keep thinking "This, too, shall pass."