The Devil Is in the Details Come to ASCA 2015 to learn about CLIA compliance BY SHERRIE GRAHAM


All facilities in the US that perform laboratory testing for health assess- ment or the diagnosis, prevention or treatment


of diseases are regulated under the Clinical Laboratory Improvement Amendment of 1988 (CLIA). Waived tests are those tests that are approved as low risk for erroneous results, but this does not mean that waived tests are completely


error-proof.


Errors can occur at any point dur- ing the testing process, particularly when a device or test kit manufactur- er’s instructions are not followed and when personnel are not familiar with all aspects of the test system. An estimated 7–10 billion labora-


tory tests are performed each year in the US. These test results influence approximately 75 percent of medical decisions.


At an increasing rate, these deci- sions are based on “waived tests,” or simple tests performed at the point of care using instruments or devices that are exempt from most federal oversight requirements. Therein lies the “devil in the details.” During my presentation, “CLIA Compliance: The Devil Is in the Details,” at ASCA 2015, May 13–16, in Orlando, Florida, I will discuss how to stay on top of your game when it comes to these requirements. In 2001, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a report that identified vulnerabilities in the enrollment and certification pro- cess of CLIA’s Certificate of Waiver pro- gram, the process that deems laborato- ries exempt from more stringent criteria.


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9 percent did not require test orders to be documented in a patient chart prior to testing. The drive toward increased regu- lation of laboratories that have been granted the certificate of waiver is also being fueled by current health care reform principles and fundamental changes in the US health care system. We can expect the number of tests per- formed at the point of patient care to continue to escalate. As we will discuss, some waived


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An estimated 7–10 billion laboratory tests are performed each year in the US. These test results influence approximately 75 percent of medical decisions.”


—Sherrie Graham, Nueterra


Consequently, the Centers for Medicare & Medicaid Services (CMS) conducted a nationwide survey of 4,214 Certificate of Waiver sites—the health care facilities that were granted the CLIA waiver— from April 2002 to November 12, 2004, and found numerous deficiencies and areas for concern, including: ■


45 percent did not document the name, lot number and expiration dates for tests performed;


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35 percent did not maintain records of their quality control testing;


31 percent did not maintain a record of tests performed; and


tests have the potential for serious health impacts if performed incor- rectly. For example, results from waived tests can be used to adjust medication dosages, such as pro- thrombin time testing in patients undergoing anticoagulation therapy and glucose monitoring in diabet- ics. To decrease the risk of erroneous results, the tests need to be performed correctly, by trained personnel and in an environment where good labora- tory practice is followed (see the Centers for Disease Control and Pre- vention’s report “Good Laboratory Practices for Waived Testing Sites” in the November 11, 2005, Morbidity and Mortality Weekly Report). My presentation at ASCA 2015


will provide an educational, user- friendly road map to compliance and laboratory quality. Each participant will receive check lists, tips and tools to help them perform a full assessment and gap analysis of their waived labo- ratory service.


Sherrie Graham is the executive director of operations/business development at Nueterra in Leawood, Kansas. Write her at sgraham@nueterra.com.


The advice and opinions expressed in this article are those of the author and do not represent official Ambulatory Surgery Center Association policy or opinion. ASC FOCUS FEBRUARY 2015


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