pinktoptube

I believe most of these tests will fall under 1976-Type LDTs which fall under enforcement discretion. The immunohematology tests that may fall the new rule would be modifications to manufacturers' instructions (i.e., you use the reagent/test in another method, you use a different specimen type or extend the specimen acceptable time limit).

We have in our blood administration policy that transfusion is given at a slow rate for the 1st 15 mins and then can be increased; we do not state this is documented. An inspector asked us for documentation to prove the rates we are using during a transfusion. We do not have a way to document this, does anyone document their infusion rates and changes to during the transfusion? The are citing PC.2.01.01 that blood transfusions are administered according to state laws and approved policies.

Experienced this. We backup the backup on an encrypted flash drive. If it happens again we would have IT give us a laptop (not connected to internet or network) to use just to pull the files.

I suppose if it was a major revision then the procedure would have been revised which would trigger a medical director sign-off.

It looks like we have the Medical Director sign-off on new forms but not revised.

The ultra-low chart is electronic, we download it monthly. Yes, it is prechilled for the freezer.

For our Ultra low freezer we change the chamber temp to the alarm range. For the freezer we are able to place the chart probe and chamber probe in alcohol and add rt water until it alarms.

We make a 0.8% suspension of donor Rhpos red blood cell unit with the diluent and then test it with manufactured control antiserum (as positive control) and saline (as negative control).

Same as cswickard, except for temp increase, we use an increase greater than 38C

Same or QC material from Quotient or BioRad works

Special Transfusion Requirements, such as Irradiate and antigen negative w/ antibody, are listed on our unit tag and record. Transfusionists are trained to review what is on the label/record with what is on the unit.

Thank you Noelrbrown.

Reviving this. We are trying to validate the Hemobioscience EluClear in gel method and we are seeing 1, 2, 4, however our last wash is clean (no hazy/grainy look, no appearance of hemolysis on the top of the gel). Any suggestions?

1. At what temp do you call it a Febrile reaction? >/= 38C 2. Do you also use temp increase from the baseline? If so what is? No 3. Do you use other criteria with Temp increase for culture? If so what are they? Have symptoms related to sepsis (CDC defin); however it is our MD call to culture. 4. If you do have one, what is your definition for tachycardia (eg =>100 bpm?) do not define 5. Same with Hypotension, any numerical definition? do not define

As the previous posters stated there isn't a requirement on the number. I reviewed every record each month for years. Probably 4 years ago I changed this to 10% of total transfusions for the month. Then about 2 years ago it was changed to at least 30 records each month.