R1R2

I know what you mean too. We would get preapproval from med director and document how testing was performed if it deviated from SOP.

You may not get reimbursed for duplicate testing.

Our SOP states the anti V is clinically significant. I agree with Malcolm's statements about anti V. I will use V negative units if the blood center can provide them but if not I will give crossmatch compatible per SOP. For reasons that Malcolm stated there is probably not a big rush to produce reagent anti V. If you are concerned about giving V negative units, you could save aliquots of your paitent's plasma to use in the future in case the blood center can't provide V negative units and the anti V falls below detectable levels.

Some transfusion services give HGBS negative if units are dedicated to a baby for "top off" transfusions, however, this is not a requirment as far as I am aware.

#2

I agree with L106. Even our Helmer fridges have humidity requirements.

I am not aware of any regulatory issues. I think if you all follow the same SOPs and you have established methods of shipping samples between sites you should be OK. You may want to have an SOP describing your "reference lab" process --who does what, when etc.

If the temp is out of range does the data logger alarm?

Hi all, for those storing blood products in a cooler for more than 4 hours how are you meeting this CAP requirement - TRM.31800 Temperature Checks Phase II Temperatures are checked and recorded on each day of use, specifying the unit and location for all temperature dependent instruments and equipment. NOTE: This checklist requirement applies to all blood component storage areas in the facility, including those located outside of the transfusion service (e.g. in surgery, nursing and dialysis units). Controlled-temperature devices used for storage of blood components must have temperatures recorded at least every 4 hours if the device does not continuously record temperature. and AABB requirment - 5.1.8.1.3 For storage of blood or blood components, the temperature shall be continuously monitored or the temperature shall be recorded at least every 4 hours

I agree with jayinsat's reasoning and I am very paranoid.

Any AABB assessors out there?

I agree with David and L106. Good advice.

This is the complete item: 6.2.3 The record system shall make it possible to trace any unit of blood, blood component, tissue, or derivative from its source to final disposition; to review the records applying to the specific component; and to investigate adverse events manifested by the recipient. How does the record system make it possible to Trace any blood or blood component, product, or tissue from source to final disposition? Review the records applying to the specific component? Investigate adverse reactions manifested by the recipient? How are archived records accessed after the method/hardware used to archive them has been changed or updated? 6.2.3.1 The records system shall ensure the traceability of all of the following: 1) Critical activities performed; 2) The individual who performed the activity; 3) When the activity was performed; 4) Results obtained; 5) Method(s) used; 6) Equipment used; 7) Critical materials used; and 8) The facility where the activity was performed. Review records (Assessor selected) and verify that the following elements are documented as applicable: Critical activities performed Staff performing the activity When the activity was performed Results obtained Methods used Equipment used Critical materials used Facility where the activity was performed I don't think this is referring to putting biomed tags on equipment or having a list of all equipment in your department. I think that this standard will require us to document what incubator, serofuge, pipette etc, was used for patient testing if there is more than one piece of the same equipment in use. There is a similar requirement in a FACT checklist for cellular product processing. I also think that this new item may go along with 5.1.3.2: 5.1.3.2 The validity of test results and methods and the acceptability of, products, or services provided shall be evaluated when quality control failures occur. What process for recall of products or services is undertaken when QC failures occur? Please provide documentation to show this. Perhaps I am over thinking this?

I am using Macopharma therapeutic phlebotomy bags. They have calibrated volume markings on the bag so a scale is not required. I have validated the bags and found the markings to be accurate to +/- 5% of volume collected.

I like the Credo cooler. It stays cool (1-6 C) for over 12 hours. The inserts need to be stored in the freezer before use so you would need extra coolers.

Hi all, How are addressing this standard: Th record system shall ensure thte traceability of all of the following: #8 Equipment used. If you have more than one piece of the same type equipment that can be used in patient testing, for example a serofuge or incubator, how are you tracking which one was used?

I have seen anti K reacting at RT many times.

Yes, the system was recording temp but not notifiying the lab of an alarm situation.

Is anyone using the Macopharma therapuetic phlebotomy bags with volume markings? Do you still use a scale? Have you done any validation of the bags to make sure that the volume markings on the bag are accurate? Thanks for your responses. R1R2

Again, depending on the discrepancy, it may be very easy to resolve. I would not repeat any time consuming tests. I think incubating tubes at RT may be the extent of investigating repeat weak plasma activity.

Depends on the type of problem, but at least once per admission.

Hi Kathy, why not get rid of the BB armbands?

I put it in the patient's history and make a comment that is was identified at another facility. R1R2

Can you write these exceptions into the validation? I would also include a plan B in the validation, such as a back up freezer with your blood supplier or a box of dry ice, just in case there are problems with the freezer validation after you move it into the new location. I would manually monitor the temps too while the validation is in progress.

I agree