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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). 

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). 

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 always kept the packing slip for 10 years as part of the traceability of unit, granted the information is entered in our LIS.

Change things as in?
From my experience, a persons understanding, willing to learn, and pro-activeness is dependent on the person and not whether they are a MLT or MT.

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.

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.

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. 

Same or QC material from Quotient or BioRad works

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.

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

We do the same with the BioRad Poly. I also include a negative cell with QC (A1 cell), just to say it reacts with IgG coated cells and Complement coated cells but not with non-coated cells. 

I'm at a 220 bed hospital, we have dedicated Transfusion Medicine technologists on all shifts. We have hired new grads, they are able to work successfully alone with proper training and the willingness to learn on their part. 

Attached is what I use. Our tissue team leader actually goes to the manufacturing sites and writes a summary on acceptability. 
TTS-PPM-FORM-035-B Supplier Review Form.doc

I believe it would need to be reported. The unit was issued with an error. It also doesn't hurt to just submit it since the FDA will let you know if it didn't need to be reported. 

I believe it would need to be reported. The unit was issued with an error. It also doesn't hurt to just submit it since the FDA will let you know if it didn't need to be reported. 

As long as the unit is being transfused I don't see why you would stop the transfusion. The crossmatch at the time of dispense was still valid. I've never been questioned on this, maybe others have.

As long as the unit is being transfused I don't see why you would stop the transfusion. The crossmatch at the time of dispense was still valid. I've never been questioned on this, maybe others have.

That is what every hospital I have worked at used for Antigen Typing proficiency.

Does this mean we get a pay increase? I wouldn't mind making a nurse salary.

Does this mean we get a pay increase? I wouldn't mind making a nurse salary.

Does this mean we get a pay increase? I wouldn't mind making a nurse salary.

Does this mean we get a pay increase? I wouldn't mind making a nurse salary.

I've seen positive autocontrols with negative DAT's, just curious if anyone has seen positive DATs with a negative autocontrol? I have always performed an autocontrol first and if the autocontrol is positive then we go to a DAT.

I've seen positive autocontrols with negative DAT's, just curious if anyone has seen positive DATs with a negative autocontrol? I have always performed an autocontrol first and if the autocontrol is positive then we go to a DAT.