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 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)
Along with requirements for personnel qualifications and quality control testing, proficiency testing (PT) is one of the central safeguards of laboratory quality under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and its regulations. The CLIA regulations have often been compared to a three-legged stool, resting on requirements for personnel qualifications and two performance indicators: quality control testing and proficiency testing. Proficiency testing is the only external performance indicator required by CLIA. Despite its central role, PT problems continue to be cited by CLIA surveyors. Among the more serious “condition level” deficiency citations given to laboratories inspected by CMS in 2012, unsuccessful PT participation and failure to enroll in PT were, respectively, the second- and third-most common citations. For all combined types of deficiencies cited by CMS in 2012 (condition and standard levels, combined), the third-most common deficiency was failure of laboratories to verify accuracy twice per year for analytes and tests for which participation in a PT program is not specifically required in CLIA Subpart I…. (Read More Here)
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)