CLIA

Regulatory

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.

Total Lab Care’s Laboratory Essentials Course has been approved for P.A.C.E.® CEU Credits

Lincoln, RI. (June 1, 2015), Total Lab Care (TLC), an ELITechGroup specialized consultant provider for Physician Office Laboratories (POLs) announces that its Laboratory Essentials Course has been approved for 3.5 hours of P.A.C.E. continuing education credits. Course participants will learn or refresh their memory on the basics of the clinical laboratory in a self-paced environment. This web-based interactive training program, comprised of 10 individual lessons, reviews CLIA rules and regulations and laboratory operations from pre-analytical to post-analytical processes including laboratory testing requirements (i.e. pipetting, safety, equipment operation, etc.).

The Laboratory Essentials course is available to current and new ELITechGroup customers and is just one example of ELITech’s commitment to help laboratories that operate closer to the patient. (more…)

Preparing for a Laboratory Inspection

Laboratory testing is regulated to determine compliance and improve patient care

In the United States, the Centers for Medicare and Medicaid Services (CMS) regulates all human laboratory testing (except research and Department of Defense laboratories) to determine compliance and improve patient care. The agency’s Clinical Laboratory Improvement Amendments (CLIA) covers about 251,000 laboratory entities. In addition, the Department of Defense laboratories (in military facilities and Veterans Affairs hospitals) accept and adhere to the CLIA requirements…

Compliance

Compliance history often dictates the occurrence of subsequent inspections. Laboratories demonstrating CLIA compliance (based on type and number of deficiencies cited previously, proficiency testing performance, and number and types of complaints lodged) may be invited to submit a self-survey document. The option to fill out an Alternative Quality Assessment Survey (AQAS) is available every other survey cycle (a two-year period). The basis for good quality patient care serves as a foundation for performing well on inspections. In other words, laboratories that pay particular attention to doing what needs to be done and documenting accordingly will be handily prepared for an inspection…(Read More Here)

With Waived Testing, Quality Must be Job One

Though uncomplicated to perform, waived tests can still result in errors if staff members are not trained.

Waived tests – simple point-of-care laboratory tests that are exempt from most federal and state oversight – are widely viewed as having little or no potential to cause harms to patients. They are straightforward to perform, and can be administered by staff with little or no specialized laboratory background.

Now used to test for a wide variety of diseases and conditions – such as drug abuse, glucose levels, pregnancy and influenza – waived testing is steadily on the increase, now encompassing 120 waived analytes and more than 4,000 waived testing systems. More than 70 percent of the nearly 235,000 laboratory testing sites in the United States today have a Certificate of Waiver from the Clinical Laboratory Improvement Amendments (CLIA) if 1988.

But, despite the growing use of waived tests – and the popular view that they are virtually “error-proof” – problems are occurring at some waived sites. Federal government research is showing that failure to adhere to something as simple as following the directions in a waived test package insert can result in testing errors. This, in turn, has the potential to affect the quality of patient care. With more than 165,000 waived labs, the impact of waived testing errors on the patient population is cause for concern – even with CMS’s ongoing random surveillance of these sites…(Read More Here)