When evaluating a new control lot number for your instrument you must run testing in parallel with your old control lot number. In this way you confirm the new lot number of control is working appropriately. It is recommended that you run at least 20 values of each control; one set of normal and abnormal controls daily for 20 testing days. You must also confirm that the values recovered and established for your instrument are within the acceptable ranges listed on the manufacturer’s package insert for the control material.
Beginning January 2016, EQC (Equivalent Quality Control) will no longer be an acceptable option for laboratories. IQCP (Internal Quality Control Plan) will be replacing EQC. IQCP is not a regulation however it will be an enforceable procedure for equivalent control testing. IQCP includes key concepts from CLSI EP-23 guidelines published in 2011. IQCP pertains to all CMS certified non-waived laboratories. IQCP does not have the same requirements as EQC. If you are following current CLIA and manufacturer’s guidelines for Quality Control testing nothing will change.
Each lab must follow both the manufacturer and CLIA guidelines for frequency and number of quality control samples tested each day. If the manufacturer’s guidelines are stricter than CLIA you cannot deviate from them for nonwaived testing.
As a Quality Advisor, I spend a lot time speaking with labs that are either brand new, in the process of getting started, or laboratories that have been in operation for years. One interesting thing I find is that, regardless of whether the lab is new or has been accredited for years, there are some common areas where labs tend to have deficiencies and therefore receive citations. Here’s some insight into what I’ve designated as the Top 5 Deficiencies for Laboratories and How to Prevent Them.
Personnel: This area tends to be one of the top cited; one reason is lack of awareness about personnel requirements for the complexity of the testing being performed…
Proficiency Testing: When it comes to deficiencies in proficiency testing (PT), what I see most often is labs not treating proficiency testing samples the same as patient samples. Sometimes this can be a source of confusion for labs….
Quality Control (QC): For QC the issue encountered most often is lack of appropriate corrective action. Running a control repeatedly until it comes in does not fix the problem! …(Read More)
On January 1, 2014, the Centers for Medicare and Medicaid Services (CMS) implemented a new alternative Quality Control (QC) option for non-waived laboratory testing. CLIA laboratories can now begin to voluntarily transition away from Equivalent Quality Control (EQC) and begin using either the default CLIA Quality Control (QC) requirement, or the new option called the Individualized Quality Control Plan (IQCP). Physician Office Laboratories (POLs) will now have to determine if IQCP is the right choice for them.