Our integrated Transfusion Services workgroup is reviewing the requirements for serological centrifuge calibration.  After reviewing both AABB (stds 3.2 and 3.5) and CAP regulations (TRM.31900, COM.30600,COM.30625,COM.30550) and manufacturer's inserts, the group still is not in accord about a standard policy.  The need to perform calibration upon receipt and after repair is very straight forward.  But for years many of the group have performed this task annually.  That is not mandated anywhere and the "functionality" testing or "defined intervals" lines in the regs leave this open to interpretation.  Therefore we wished to poll this group to see what our peers are doing.  We would love to hear what other sites are doing to determine if there might be a national best practice in the US as part of our review before making a final policy determination.

 

 

  In the AABB Manual, it still suggests that the speed and times check be completed quarterly and the function yearly. This is on page 29 in the Technical Manual. This is what we still follow.

I used to calibrate serofuges annually.  Haven't done so in years.   Upon receipt and major repairs.  As long as the rpms remain consistent (biannual) and the cell buttons are well-delineated, we have not performed calibrations.  However, when I have BB students I always give them the opportunity to experience calibrations of this nature.

4 hours ago, Kathyang said:

  In the AABB Manual, it still suggests that the speed and times check be completed quarterly and the function yearly. This is on page 29 in the Technical Manual. This is what we still follow.

what version of the technical manual are you quoting?

We check speeds and times quarterly, "calibration" (cell-button acceptability at different times) annually.

Scott

Per AABB 31st edition of BB/TS standards:

3.5.1

Calibration of Equipment:  Calibrations and/or adjustments shall be performed using equipment and materials that have adequate accuracy and precision. At a minimum, calibrations and/or adjustments shall be performed as described below unless otherwise indicated by the manufacturer:

  1) Before use.

  2) After activities that may affect the calibration.

  3) At prescribed intervals.

However,it further specifies:

 

3.5.1.2

Calibration procedures shall follow the MANUFACTURER'S WRITTEN INSTRUCTIONS and shall include: 

1)          Instructions for performing calibrations.

2)          Acceptance criteria.

3)          Actions to be taken when unsatisfactory results are obtained. 

We currently do calibrations once per year with bi-annual RPM checks on our Serofuges but quarterly on our CW2+ cell washer (both per manufacturer recommendations).  However, we are getting new Bio-Rad IH-centrifuges next month so I'm sure this will change.  I think you should probably determine your own prescribed interval for completing the calibrations if the manufacturer doesn't specify.  Maybe before use, after repair and if results are not satisfactory as opposed to annually?  

We perform upon receipt and after repairs for the full calibration.  Spin speed is checked annually.

New York State specifically requires this annually