Medtronics HMS+ HDR/HPT calibration verification

Hello.  This is what I have to meet COM.01500 Alternative Performance Assessment for HDR and HPT Cartridges.  I have four HMS Plus instruments in service. 

COM.01500 Alternative Performance Assessment 

No commercial CAP Proficiency Test exists to monitor the performance assessment of HDR and HPT cartridges.  In line with manufacturer’s recommendations:   

1.      The slope from the HDR cartridge is assessed monthly.  A new slope range is calculated monthly.  A new average is obtained and the new range is ± 3SD of the average.

2.      Hepline Linearity Kit is used to assess HPT cartridges at least twice annually. Following Hepline Kit package insert instructions, all four HMS Plus instruments are measured using varying amounts of heparin in vials 1 - 5 to the corresponding cartridge color.  For passage, each Hepline Kit vial sample must clot in the following cartridge channel: 

a.      Vial 1 (red) –     channel 3 or 4 

b.      Vial 2 (tan) –     channel 1 or 2  

c.       Vial 3 (tan) –     channel 3 or 4 

d.      Vial 4 (blue) –    channel 1 or 2 

e.      Vial 5 (green) – channel 1 or 2 

Corrective action for Hepline Kit vial sample not clotting within the designated cartridge channel:  repeat the test using fresh donor sample, a different Hepline Linearity Kit, and different cartridge(s).  If results of the repeat Hepline Kit vial sample still does not clot within the designated cartridge channel, call Medtronic Technical Service for additional guidance or to schedule preventative maintenance (the failed instrument is taken out of service until a resolution is determined).   
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the HDR Cartridge package insert states the following:  The HDR cartridge provides a derived value from a set of functional assays (blood heparinized to differing concentrations) on freshly drawn whole blood.  At present, there is no commercial control available which adequately addresses quality control of the HDR cartridge.  However, the performance of the cartridges may be evaluated for quality purposes by drawing a known donor, running an HDR cartridge, and recording the results for evaluation.  I evaluate the cartridge using myself as a donor.  I collected five different samples from myself over the course of five weeks,  Results of HR-ACT (Baseline ACT), Slope and Average Clot Time in channels 1&2 and 3&4 were performed.  The mean, standard deviation (+/- 2SD) and +/- 10% of the mean (for HR-ACT) were calculated of the five samples submitted.   Whenever I receive a new shipment of HDR cartridges, for quality purposes, HDR cartridge results each new shipment or lot must fall within the MUST fall within evaluation criteria, as defined below: 

·         Baseline HR-ACT:            110.7 – 135.3 seconds 

·         Slope:                                57 – 95 secs/unit/mL

·         Avg Clot Time 1&2:           309 – 358 seconds 

·         Avg Clot Time 3&4:           213 – 263 seconds 

·         Proj Hep Conc:                  2.9 – 4.1 mg/kg

 

You may also want to put a disclaimer stating:   with each new lot of HDR cartridges, the POC Coordinator evaluates the donor sample to determine if the evaluation criteria need to be adjusted.   

Hope this helps.  
David 

   

also, for HR-ACT comparability across instruments, I use CAP participant survey CT1,  Activated Clotting Time

Thank you David. Awesome reply. I really appreciate it. 

You're welcome.