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heathervaught

CAP TRM.40120

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I need some guidance!  I did a quick search of the forums for any discussion about this, and the most current posting was in 2010.  I'm wondering if anyone has any new information, new experiences, or any advice about CAP TRM.40120.  The note states "...all analysts participate in QC on a regular basis."

How frequently is "regular"?  For example, when I was looking to complete our annual Competency assessment in September (don't ask...), I was looking for evidence that each individual who performs MTS testing had performed MTS QC.  There were some employees who had not performed MTS QC yet in 2016.  I'm inclined to say that someone who hasn't performed QC in at least 8+ months is not participating in QC on a regular basis.  Being new to my role, I'm just not sure how the assessors interpret this standard, and how others provide evidence of compliance. 

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This is a very good/loaded question. See also 42 CFR 493.1256 "Standard - Control Procedures":

(d) Unless CMS approves a procedure,

specified in Appendix C of the State

Operations Manual (CMS Pub. 7), that

provides equivalent quality testing, the

laboratory must—

(7) Over time, rotate control material

testing among all operators who perform

the test.

 

After my interpretation of the CAP standard and the related CFR, I implemented a rotation of QC across all shifts. It was the bane of our day shift technologists (previously night shift did rack QC and evening shift did ProVue QC), but on the other end, we've virtually eliminated FDA biological product deviation reports related to routine QC problems and everyone seems to have a better handle on QC as a whole.

I am in the camp that disagrees that 'regular' or 'over time' can be interpreted as "when we need them to do QC for annual competency assessment."

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Day shift does QC on a regular basis.  Other shifts are required to do QC (the whole daily QC) on a quarterly basis.  I get pretty good compliance with this.

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My day shift (normally me) does the QC on the Echo, and the Evening/night techs do the rack QC, and since they sometimes alternate their shifts, everyone gets a chance to do the QC/maintenance.

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