DFields

This is also required by the CFR.

I caution you to check the FDA Enforcement report and see the numbers of BPDs filed for errors in antigen typings. We have found errors, albeit rarely, and choose to retype the units set for patients with antibodies or antibody histories!

How do you meet Std 5.4.3.1 program to reduce the risk of reactions in young donors? What are other organizations doing to meet the intent of the (relatively) new standard 5.4.3.1, which states "The collection facility shall have a program to reduce the risk of reactions in young donors."

New post for ongoing discussion: to test or not to test? Is your institution using leukoreduced and not performing CMV testing? Are you giving CMV seronegative and leukordeuced only for neonatal patients?

[h=2] A physician has contacted our blood bank regarding solvent detergent plasma, since it is being advertised as "TRALI-risk free". Are other blood banks planning to stock and use this product?[/h]

Since there is now a licensed confirmatory test for T. Cruzi, will there be a mechanism by which to reenter a donor who was repeat reactive for the screening test? I do not see any update since the 2009 FDA Guidance, which states that a repeat reactive must be indefinitely deferred.

AGREE! Never accept back a spiked blood component. The ward has up to 4 hours to administer the product once it is spiked.

I agree with profbaud

"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 have been doing irradiation for many years and are inspected by FDA, with no problems as to use of the indicators. My inderstanding is that these are used as QC indicators for the batch and do not actually "measure" the specific amount of irradiation delivered--but rather show that the batch was actually exposed to radiation. The dosimetry which is periodically required (annually for CS137) measures the dose delivered to various parts of the canister and ensures the 2500 Gy at midpoint and 1500 Gy overall.

Be careful because the Joint Commission requires that the actual TEMPERATURE of alarm activation be recorded, not just place a check mark in a box that the alarm activation was done. I believe this is a good requirement to make sure the instrument is warning the user at the proper temperature.

**REVISED** 07/11/2011 [TABLE=class: MsoNormalTable] [TR] [TD=width: 88, bgcolor: transparent]TRM.40230 [/TD] [TD=width: 481, bgcolor: transparent]Compatibility Specimen Labeling [/TD] [TD=width: 95, bgcolor: transparent]Phase II [/TD] [/TR] [TR] [TD=width: 88, bgcolor: transparent] [/TD] [TD=width: 575, bgcolor: transparent, colspan: 2]All blood samples used for compatibility testing are labeled at the time of specimen collection in the presence of the patient with: 1. Patient's first and last name 2. Unique identification number 3. Date of collection 4. Initials or other identifier of the phlebotomist. NOTE: Blood specimens collected for compatibility testing must be positively and completely identified and labeled before leaving the patient. Acceptable practices for positive identification of patient and blood specimen labels must be defined in the procedure manual and may include visual inspection and/or an electronic system to read the identifying information contained in bar codes or radio-frequency identification (RFID) microchips or the patient's wristband. Acceptable practices for generating specimen labels must be defined in the procedure manual and may include electronic devices utilizing information encoded in bar codes or RFID microchips. There must be a dependable method to identify the phlebotomist who collected the blood sample. Evidence of Compliance ✓ Written procedure defining labeling requirements of specimens for compatibility testing REFERENCES [TABLE=class: MsoNormalTable] [TR] [TD=width: 23, bgcolor: transparent]1) [/TD] [TD=width: 639, bgcolor: transparent]Wenz B, et al. Practical methods to improve transfusion safety by using novel blood unit and patient identification systems. Am J Clin Pathol. 1997;107(suppl 1):S12-S16 [/TD] [/TR] [TR] [TD=width: 23, bgcolor: transparent]2) [/TD] [TD=width: 639, bgcolor: transparent]Dale JC, Renner SW. Wristband errors in small hospitals. A College of American Pathologists' Q-Probes study of quality issues in patient identification. Lab Med. 1997;28:203-207 [/TD] [/TR] [TR] [TD=width: 23, bgcolor: transparent]3) [/TD] [TD=width: 639, bgcolor: transparent]Sandler SG, Langeberg A, Carty K, Dohnalek LJ. Bar codes and radio-frequency technologies can increase safety and efficiency of blood transfusions. LabMedicine 2006;37:436-439 [/TD] [/TR] [TR] [TD=width: 23, bgcolor: transparent]4) [/TD] [TD=width: 639, bgcolor: transparent]Sandler SG, Langeberg A, DeBandi L, Gibble J, Wilson C, Feldman CL. Radio frequency identification technology can standardize and document blood collections and transfusions. Transfusion 2007;47:763-70 [/TD] [/TR] [/TABLE] [/TD] [/TR] [/TABLE]

I did not see it also mentioned to follow the tube manufacturer's instructions for use (IFU) for the centrifugation times/speeds--depending on which type of tube you are using.

Echo that, never rely on past history, must recheck a current sample!

I agree with Ms Croke!!

A recent JC survey preparatory "class" for our hospital stated that (from an infection control perspective) no fans are allowed in clinical spaces. Do Blood Bankers allow fans in their spaces when the temperature is too warm? What about Transfusion vs Donor Centers?

We used to use ZZAP and then WARM, but have switched to Peg adsorptions and they are so much easier and faster..

What type of tabletop sealer do you recommend for purchase? Do you use hand-held sealers in you blood center as well as tabletop?

Where is the FDA as far as approval of a platelet additive solution, rather than having them suspended in plasma?

The recent software upgrade has 2 problems that were discovered after it was released and installed: these are about (I have not worded them precisely): 1. lot number changes of reagent cells are not flagged 2. if there is a certain error flag on a card, the last well in that card will not have sample dispensed--this would be obvious in a reverse type or antibody screen (would be NRD) but in a panel the last cell could be a false negative since no sample was dispensed. The notification came from Ortho to users last week. We went back through panel results to make sure that error flag was not on any of those runs since the software upgrade was installed.

In 2010, do you store and issue factors in the Blood Bank, or are they kept in the Pharmacy? What about Factor VII concentrate, does Blood Bank issue and is there a protocol at your institution?

Another related question--as far as tracking the cumulative plasma loss and rbc loss, what record-keeping tool do you use-or does your computer system do this rolling total for you? Does the Blood Bank Medical Director review the labs from your apheresis donors, and if so-how often?

Does your institution do ANH? If so, can you share your protocol please?

Does anyone have a letter example which they send to a donor whose sample cannot be found either neg or pos for HBsAg? Are those donors kept ('forever') on a permanent deferral since the sample is non-confirming?

I would like to obtain a "poll" from other centers as to the following: 1. At what time after collection do you take the sample for bacterial detection? 2. Is this time calculated from START or from STOP time of the collection? 3. If using the culture method, how long after inoculation is the product made available to inventory? Thank you in advance for your responses. Please just list as 1.-, 2.-, 3.-