Accrediting Agencies

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…

Question says "If laboratory uses more than one instument/method to test, are the instruments/methods checked against each other at least twice a year for correlation". Just wondering if this would apply to hospitals using both gel and tube methods. We mainly use gel (manual), but on occasion will use our tubes as backup or just to do a quick blood type. Do we need to be doing correlations between these methods or is this more for instrumentation?

I was just wondering if there are hospitals out there using expired panel cells (we use both 0.8% and 3-5% cells) to do select cells, if current lots do not have the donor cell needed to rule in and/or rule out an antibody? If so how do you go about validating the expired cells for patient use or showing CAP that it is okay to use expired cells for testing. The CAP standard in question is TRM 312.50, which states reagents must be used in their indicated expiration date, but the note says rare reagents may be used beyond their exp date if appropriate controls are ran. We had been considering these expired cells needed for rule outs as "rare" and running positive control (t…

our lab recently has promoted a mlt(ascp) to be the section supervisor of our blood bank. we were told that this was okay per cap trm rules. what about clia supervisor rule? and any jcaho stds involved with this selection? the person involved has very few years as tech mostly on nights. title should say testing not esting. sorry <admin comment> fixed

A question just came up in our transfusion service regarding the CAP Comprehensive Blood Bank survey. We have traditionally assigned this to one individual to perform all testing. The question is: Can we split this survey to test five different techs by assigning one specimen to one tech? We've been debating this. Has this happened at your facility? How did your inspectors look on this action? We'll accept all opinions! Thanks

What kind of timing are you all seeing for CAP inspections now that they are surprise? Are they coming the first month you are eligible for inspection, 2-3 months later or is it widely variable? Please share your experiences. Thanks.

The checklist says "If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results". I had interpreted this requirement applies to routine blood group and Rh test and antibody screen only. It should not apply to antibody identification methodologies because different methodologies can be used to identify the antibody depending on the characteristics of the specific antibody. But now there is opinion saying that this also applies to the antibody identification testing. Please share your thoughts on this, particularly if you are t CAP …

TRM.20000 - has to do with a documented QC/QM program specific for Transfusion Medicine. We just had our CAP inspection and were cited for not having a QM program specific for the tranfusion service. The General Lab QM program was not enough. I shudder to think of writing one from scratch. Does anyone have an outline you would be willing to share? It would be greatly appreciated and extremely time saving. Melissa

I just heard from a local lab that they have been sited by the CAP for not testing new lots of reagents against patient specimens tested with the previous lot. Is this something a lot of people are doing? Isn't reagent QC before putting the lot into use enough? They are being inspected using the Immunology checklist as opposed to the Transfusion Service checklist but I see nothing in either that says patient specimens must be used for validating reactivity. Thanks!

With the new JCAHO standards for tissues, our surgery department is having a difficult time tracking all of the tissues used, other than by a manual method. Our present plan is for ALL of these (including the room temperature storage ones) to come to BB and we will use our computer system to track them as a blood product. This is not a great solution, as it takes more time for us and the surgery staff, but is the only way we have come up with to assure the tracking will meet the standards. Does anyone else have a better system within their facility? I am interested in computer programs that can be used by the OR staff (hopefully something that can interface with our Med…

Does this mean that US regulated laboratories are unable to use panel cells beyond their expiration date even if the facility has a defined policy for exceptions? See checklist below: TRM.31250 Reagent Expiration Dates Phase II All reagents are used within their indicated expiration date. NOTE: Rare antisera may be used beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected. For laboratories not subject to US regulations, expired reagents may be used only under the following circumstances: 1.The reagents are unique, rare or difficult to obtain; or 2. Delivery of new shipments of reagents is delayed thro…

The facility that I currently work at has gone crazy with their rules and regulations. I was wondering if there are any other labs out there that do parallel testing with a patient on blood banking regents. I remember when working in another facility, all we had to do was QC new lots or newly opened bottles. I know that parallel testing is a common procedure in chemistry amongst many other departments, but I never really seen a specific "lot to lot" procedure in a blood bank.

If I am interpreting this CAP requirement correctly, in addition to having the 72 hour maximum interval between specimen draw and crossmatching for patients with previous txn or pregnancy within last 3 mos or unknown history, there is also a requirement for a maximum interval to be set for all patients that do not fall in these categories. I do not however, find anywhere that states any limit to that maximum interval. We currently allow a week. That seems to be adequate time for preop testing, etc. We occassionally have requests to extend this over a longer period of time, mainly for patient's convenience in not having to make an additional trip to our facility. What…

"New reagent lots...are checked against old..or concurrently with being placed into service." This is a new CAP Common checklist question as of 7/31/12 (Phase II) and it goes on to state for qualitative tests, minimum cross-checking is to include retesting at least one know positive and one known negative sample form the old lot against the new. Are other Blood Banks doing lot to lot testing, including patient samples? What about for fetal screen and Kleihauer Betke?

We recently had an inspection with Joint Commision and were told that FFP after thawing needs to be relabeled as "Thawed Plasma" prior to issuing for transfusion. Has anyone else heard this? I can't find anything about how to relabel or if there are any regulations regarding this. FYI-this would be for issuing within the 6 hour limit.

"If the laboratory uses more than one instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for correlation of results." My hosptial uses the Echo. We also have a Manual Station Solid Phase platform for antibody screens and antibody IDs. And we also have tubes, My question is: What happens when the Echo gets a 2+ for a Jka, the manual platform gives a 1+, and the screen is totally negative in tubes? Am I compliant? The Echo and solid phase are so much more senstive. Tubes are not going to 'catch' every single antibody - we know that. So, what do I do? Should I not be comparing tubes to solid phase (appl…

It states : If the laboratory uses more than one instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for correlation of results. NOTE:This requirement applies to tests performed on the same or different instrument makes/models or by different methods. This comparison must include all nonwaived instruments/methods. The laboratory director must establish a protocol for this check. This would mean that if you use a cellwasher to wash your tubes, you would have to compare each maker or model against the other?

Dear all Please can someone tell me exactly what the latest official FDA or AABB requirement is for the frequency of running reagent controls? Is it every day, every time you open a new lot, every shift, every week................. Thanks Anna:thanks:

How are you documenting the historical record check when a sample arrives in your blood bank? EOC required includes "records of historical checks". We are using HCLL, and the system functionality allows us "to compare ABO,Rh and antibody screen results against previous results to detect discrepancies and identify patients requiring special units". When I called CAP about this regulation, and even explained the safeguards and features of HCLL they said they require documentation that someone physically viewed the required information. They suggested we add a patient comment that a history check was completed for each new sample received. This really appears to be duplicati…

Has anyone started working on an IQCP plan? I'm starting to look over the information to write one for the HIV test kit we use in Blood Bank. Lots of IQCP's will have to be written in my lab. I cannot find an example of one that's already written to compare mine with....does anyone have one they are willing to share? Or does anyone have an IQCP development policy Any help/comments appreciated! Natalie

A new question dated 12/29/04 states"Does the facility have a documented program to ensure that the risk of pretansfusion sample misidentification is monitored and subjected to continual process improvement?" The NOTE goes on to say:Approximately 1 in 1000 specimens for pretransfusion testing are mislabeled. Multiple methods exist to reduce incidence including 1) documenting the ABO on a second sample collected at a seperate phlebotomy; 2)identification by a mechanical or electronic identification sysem; 3)issuing only Group O, 4) documentation of ABO from previous records. Some of these are not practical, especially if you are not using the computer crossmatch and some w…

I heard a blood bank was recenlty sited by CAP for not validating their antisera (tube testing) when switching manufacturers. What are sites doing to validate current vendor against old with tube tesitng (AB0, RH, rare). Has anyone heard of this? If so, what is standard and/or CAP requirement they are siting.

A patient who receives irradiated blood has an unexpected massive bleed. Ten units of uncrossmatched blood are requested emergently. Blood Bank Director makes a medical decision to not irradiate the units. This is documented on our internal deviation from SOP. Is it FDA reportable?

Need clarification. Does daily QC on the Provue satisfy the reg for performing daily QC on manual gel as long as the autopipettes,centrifuge, and temperatures are checked? At the present, manual gel QC is done only if the Provue is down.

Can anyone please tell me their interpretation on this question concerning a small hospital blood bank that doesn't "manufacture" any products. My medical director and I are having a slight disagreement on the interpretation. Thank you! **NEW** 10/31/2006 TRM.30950 Phase I N/A YES NO Is there a policy requiring notification of the Centers for Biologics Evaluation and Research according to U.S. federal regulations when a biological product deviation occurs? NOTE: A manufacturer is required to report to the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) as soon as possible, but not to exceed 45 calendar days from …