tcoyle

Hi, can you cite the standard/regulation that requires biannual validation?

CAP All Common 30400 was recently revised; Transfusion service laboratories may use rare reagents (ie, rare antisera and selected panel red cells to determine the specificity of red cell antigens and antibodies) beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected. The laboratory must have in-date reagents for routine antigen typing and antibody panel testing. I suppose the validation could document how long those cells could be used past expiration...a week; two weeks, etc.

Blood products that were taken into isolation are never returned to us. If they are not used, they are discarded in the room.

Hi, you could start with the medication deferral list that is provided to blood donors to review to determine their eligibility. Meds that may affect blood products are most likely listed here. http://www.aabb.org/tm/questionnaires/Documents/dhq/v2/DHQ Medication Deferral List v2.0.pdf

I hope you are stating the AP are FFP and your O inventory are RBCs?

Dear Misty, so much happening! Does this person have training records? Competency? Does your facility have an institutional patient safety reporting? However, I think this goes well beyond that. It is a patient safety issue and would recommend you take your documentation to his manager. This seems like reckless behavior, which in the event management world should become an HR issue.

We have a process for a new piece of hardware such as this. The lab will print a label from the printer. Attach this to the form that we use or another piece of paper. They also take a screen print from the application that label was printed. They then compare the printed label to the information in the application. It's all documented on a worksheet and kept in the work unit for the required record retention.

As far as I know, FDA currently has a draft guidance for pathogen reduced platelets. FDA recently came out with the final regarding bacterial risk and platelets. You can search for FDA guidance's any time. Copy this link https://www.fda.gov/regulatory-information/search-fda-guidance-documents

What does the manufacturer of the WB bag state in their package insert?

We have a label adherence validation that we do with the label and bag set; so we validate that the label will adhere in all conditions that it may incur. That could be anything from the blast freezer to a microwave for thawing and of course refrigerator/RT/Freezer conditions. We do this with any new label stock that we would receive prior to putting it into use. We basically test the label as it goes thru the manufacturing, storage and processing life cycle.

While not endorsing anyone, we use digitrax labels. We also have a robust pre-qualification/label adherence protocol to ensure that they will stay put in all situations. We also ensure that these labels meet the FDA regs for adhesive.

Hey Cliff, What standard/checklist item were you cited against?

31st edition of the AABB Standards 5.1.1 Change Control: The BB/TS shall have a process to develop new processes or procedures or to change existing ones. This process shall include identification of specifications and verification that the specification have been met. Before implementation, the new or changed processes or procedures shall be validated. Stand 2.12 applies. To show that your laboratory isn't changing things on the fly, it is important to have a controlled process in making changes. AABB has a section on their website under the Accreditation Member Tools a Commendable Practices link. You may be able to glean some information on how to set up a change control process for your laboratory.

Are you creating your own software?

According to the CMS guidelines you do not need to develop one, as long as you are performing the required QC. This is a snippet from that additional information link: I HAVE ALWAYS FOLLOWED MANUFACTURER’S INSTRUCTIONS FOR QC IN MY LABORATORY WHICH IS LESS THAN THE CLIA REQUIREMENT OF 2 LEVELS OF QC EACH DAY OF TESTING. WHY DO I NEED TO CONSIDER DOING AN IQCP? Effective as of January 1, 2016, if you wish to continue your current QC practice you will need to perform an IQCP. During test system development, manufacturers challenge their tests in many ways to identify possible failures and build in features to reduce the risk of those failures. However, manufacturers’ instructions for QC may not address all the risks, potential errors and variables that are specific to your laboratory’s situation. Developing an IQCP will address the risks that are specific to your laboratory and help you determine the appropriate QC for your patient testing.