Cliff

@John C. Staley, this may be true, but the FDA does actually review each file. They notify us a couple fo times a year that an event is not reportable.

We get ours pre-pooled from ARC. Far too much QC needed to do it in house. Also, I your LIS may not play well with a mixed ABO.

Many variables there, might be hard to compare. We transfuse about 35k products a year and have a small donor center. We send FDA 50 - 75 reports a year.

Maybe try here? https://loopsters.org/index.php?/forums/

Michael, Please stop posting ads in the forum. Thanks

These posts are not allowed here.

Correct Blood Bank Nomenclature Correct Blood Bank Nomenclature This question was submitted by forum member, Malcolm Needs. Any errors are those of the site admin, not Malcolm. Correct Nomenclature in Transfusion Science.pptx Submitter Cliff Category BloodBankTalk Submitted 02/12/2018

We don't have any. We have some we use to validate modifications to our tube system and we validate those before each validation. Actually we have donor thermometers and those we validate monthly.

I view the chart drive and digital display as electronic thermometers. When we used them in the distant past, we validated / calibrated them monthly. When we moved to Rees, they told us there monitoring devices were thermistors and are only required to be validated annually. [Title 21, Volume 7] [Revised as of April 1, 2017] [CITE: 21CFR606.60] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F--BIOLOGICS PART 606 -- CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Subpart D--Equipment Sec. 606.60 Equipment. (a) Equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be maintained in a clean and orderly manner and located so as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on a regularly scheduled basis as prescribed in the Standard Operating Procedures Manual and shall perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in this chapter for blood and blood products. (b) Equipment that shall be observed, standardized and calibrated with at least the following frequency, include but are not limited to: Equipment Performance check Frequency Frequency of calibration Temperature recorder Compare against thermometer Daily As necessary. Refrigerated centrifuge Observe speed and temperature Each day of use Do. Hematocrit centrifuge Standardize before initial use, after repairs or adjustments, and annually. Timer every 3 mo. General lab centrifuge Tachometer every 6 mo. Automated blood-typing machine Observe controls for correct results Each day of use Hemoglobinometer Standardize against cyanmethemoglobin standard ......do Refractometer Standardize against distilled water ......do Blood container scale Standardize against container of known weight ......do As necessary. Water bath Observe temperature ......do Do. Rh view box ......do ......do Do. Autoclave ......do Each time of use Do. Serologic rotators Observe controls for correct results Each day of use Speed as necessary. Laboratory thermometers Before initial use. Electronic thermometers Monthly. Vacuum blood agitator Observe weight of the first container of blood filled for correct results Each day of use Standardize with container of known mass or volume before initial use, and after repairs or adjustments. (c) Equipment employed in the sterilization of materials used in blood collection or for disposition of contaminated products shall be designed, maintained and utilized to ensure the destruction of contaminating microorganisms. The effectiveness of the sterilization procedure shall be no less than that achieved by an attained temperature of 121.5 deg. C (251 deg. F) maintained for 20 minutes by saturated steam or by an attained temperature of 170 deg. C (338 deg. F) maintained for 2 hours with dry heat. [40 FR 53532, Nov. 18, 1975; 40 FR 55849, Dec. 2, 1975, as amended at 45 FR 9261, Feb. 12, 1980; 57 FR 11263, Apr. 2, 1992; 57 FR 12862, Apr. 13, 1992]

Antibody/Antigen Reaction Antibody/Antigen Reaction This question was submitted by forum member, Malcolm Needs. Any errors are those of the site admin, not Malcolm. Antibody Antigen Reactions .pptx Submitter Cliff Category BloodBankTalk Submitted 02/02/2018

Correct Blood Bank Nomenclature This question was submitted by forum member, Malcolm Needs. Any errors are those of the site admin, not Malcolm. Submitter Cliff Category BloodBankTalk Submitted 01/15/2018

Can I ask why? If you are a huge facility and are trying to save money, you would make these from whole units. You'd have the resources to ensure they reagents are up to FDA requirements and the proper documentation was available for inspection. If your a small facility and are trying to save money, the few pennies you might save just aren't worth the regulatory risk. If not's not money, what might it be? Just curious.

Welcome

Welcome

Ensure you use a vendor that uses an FDA approved adhesive. 21 CFR 175.105

It's mislabeled, so yes, it's reportable. We are pretty big, and send in a lot of reports. The FDA is really easy to work with. I've had a couple of phone calls (they called me) and many emails regarding our reports. Again, always helpful.

Happy holidays to all.

This. We rarely outdate any.

Not even a week ago? Will the site let you try again? It's not supposed to.

Clinical Aspects of Transfusion Reactions Clinical Aspects of Transfusion Reactions This question was submitted by forum member, Malcolm Needs. Any errors are those of the site admin, not Malcolm. Clinical Aspects of Transfusion Reactions.pptx Submitter Cliff Category BloodBankTalk Submitted 12/11/2017

@SMILLER, we have always been able to determine who received our products, including all emergency release products. We have a form the physician signs that lists the units. The blood bank issues those products (when they have time) to that patient and we can track where every product goes. What I take exception to is the inspector insisting that we also put the patients name and MRN on the product. They again insisted this made the process safer. It does not in any way make it safer, especially if it's a system assigned name / MRN and more importantly, when it takes a modest amount of time to generate these labels. We have done a tremendous amount of planning to ensure we can give out emergency release coolers, almost on demand. It takes us very little time to give the requester their products, these labeled units have put a significant delay on that, and in my opinion, has deceased patient safety.

Yup, that was about how our inspection went. We were made to feel like we were murdering patients by not having a fake name, attached to a universally "safe" product, being infused into a exsanguinating, unidentified patient. I understand the need for rules, but saving the patient comes first. We do have a trail of who got what. The idea that having a fake name on a product makes is safer is very frustrating.