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IQCP, Are You Ready?

On January 1, 2016, CLIA  equivalent quality control (EQC) options will no longer be allowed. As of that date, labs must revert to the traditional CLIA quality control (QC) requirements or have in place individualized quality control plans (IQCP’s) for these lab tests.  Labs will be allowed to revert to traditional QC (2 levels of controls with each day or run) for those tests that they previously used EQC but all EQC must be discontinued January 1st

However labs that want to take advantage of the electronic or integrated controls, preparing IQCPs will be the only allowable alternative to traditional QC.  The IQCP is a documented compilation of actions that controls the quality of a test from the time it is ordered, until the results are reported.  The plan is customized for each lab’s specific scope of operations and considers factors such as environment, patient population, test method, clinical use, and personnel competency. An IQCP is required to have 3 parts:  a risk assessment, a QC plan, and a quality assessment.  Some examples of tests that may require an IQCP plan include: amnisure, mycoplasma, serum pregnancy test (urine is waived), HIV,  triage meter, I- Stat (depends on specimen type), Siemens Stratus, fetal fibronectin etc.  Generally whole blood specimen may be used for waived testing.  If the specimen is spun down to separate the serum, it becomes a moderate complexity test.

It is not required to use special charts or diagrams to develop your risk identification for your tests but it may be helpful. CLIA also requires that the IQCP include the entire testing process, from ordering through reporting (preanalytical, analytical and post analytical).  CLIA requires that a risk assessment consider 5 testing components: patient sample, testing personnel, reagents, environment and testing system.  There is a great deal of information on the CMS/CDC and CLIA website found by simply googling IQCP.  

We are attaching 3 documents to use as examples:

1) QC procedure for tests requiring an IQCP (You must have a procedure in place for how you develop your IQCP plans for your appropriate lab tests)

2) Sample hCG serum pregnancy test IQCP summary

3) Sample hCG serum pregnancy risk assessment

Lyle Barksdale, MD

Contact Number:  308-696-7788

Karen Hastings, BS, MLS (ASCP)

Contact number:  308-532-4700

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