HEM.20090 Alternative Control Procedures

[BenchTech]

As we do our self inspection I have come across this new CAP requirement.

**NEW**       08/17/2016 
Alternative Control Procedures
If the laboratory performs test procedures for which control materials are not commercially available, there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded.
NOTE: "Performance" includes elements of accuracy, precision, and clinical discriminating power. Examples of alternative procedures may include split sample testing with another method or with another laboratory, the testing of previously tested patient specimens in duplicate, testing of patient specimens in duplicate, or other defined processes approved by the laboratory director.
 

I have a number of tests that do not have commercial QC, Gastrocult, Hansel Stain, Giemsa Stain, PFA, and HITs. 

My questions are:

Does anyone know of any commercial QC for any these tests?

Anytime we do a Wright or Giemsa stain we generally judge the quality as our QC. For Hansel we do stain a blood smear that has a high Eos count. Does anyone do anything different?

Thanks!

 

[nziegler]

Gastroccult: QC is built into the card, just like Hemoccult, so external QC should not be required.

Hansel stain: we also make smears with high eosinophil counts and the techs must indicate on the log that the nucleus stained blue and the granules stained pink/orange

Giemsa: we also judge quality as our QC, the techs check off that they checked stain quality and there is a statement at the bottom of the log indicating what "quality" means

PFA-100: as per the manufacturer, you must identify "normal donors" from your staff to be used as a monthly control

HIT: can't help you there. We will be using IL's reagent which has commercial controls available