Centers for Medicare and Medicaid Services (CMS) Survey and Certification Group (SCG) Mission:

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1 CLIA Presentation The Committee on the Return of Results of Individual- Specific Research Results Generated in Research Laboratories The National Academies of Sciences, Engineering, and Medicine July 19, 2017 Karen W. Dyer, MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services Baltimore, Maryland 21244

2 Centers for Medicare and Medicaid Services (CMS) Survey and Certification Group (SCG) Mission: To assure health care quality and safety for the U.S. public through survey, certification, and public information of providers' and suppliers' quality of care. 2

3 Early Laboratory Oversight Impetus for Clinical Laboratory Improvement Amendment (CLIA) Deaths/unnecessary surgeries due to inaccurately read Pap smears Proliferation of black box technology and no oversight in physicians offices Congress passed the Law in 1988 Regulates all testing on humans for health purposes using minimum quality standards Intent of CLIA Law: ensure accurate, reliable, timely testing regardless of location (including research) when individual patient results are returned. 3

4 From the House of Representatives Report These tests are critical to proper patient care when properly used and when the tests are accurate and reliable. When they are inaccurate or unreliable, however, the consequences are improper treatment, unnecessary mental and physical anguish for patients, and higher health care costs. (Pg. 10) The use of untrained personnel to perform tests, the lack of basic quality control and quality assurance measures and failure to participate in proficiency testing programs were major sources of concern. (Pg. 15) 4

5 From the House of Representatives Report Findings (Pg.18) Laboratory testing is a critical element in the delivery of healthcare; Accurate and reliable testing is vital to the public health of all Americans Unregulated laboratories can compete unfairly with regulated laboratories, by performing tests at lower cost, but at risk of lower accuracy and reliability; Unregulated laboratories impair the effectiveness of the health and safety regulations governing other laboratories 5

6 Clinical Laboratory Improvement Amendments (CLIA) Revised Section 353 of the Public Health Service Act (42 U.S.C. 263a) A clinical laboratory was defined as: A facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. 6

7 The CLIA Program: Funded by user fees; no start up funds Covers ALL TESTING on humans specimens for health purposes, to include research when such laboratories return patient specific results. 255,170 laboratories enrolled Foreign laboratories that receive US samples Excludes forensic testing and paternity labs 7

8 CLIA Research Exception 42 CFR 493.3(b)(2) These rules do not apply to components or functions of research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients. CLIA applies when: Patient specific results are reported from the laboratory The results can be used for health care for individual patients 8

9 Quality Standards The Value of CLIA Certification Quality Control (QC) Proficiency Testing (PT) Personnel Qualifications and Responsibilities Recordkeeping Quality Assurance or Assessment (QA) Performance specifications in CLIA regulations allow laboratories flexibility, opportunities for new advances in technology, and innovation. 9

10 PERCENTAGE OF LABORATORIES DEFICIENT The Value of CLIA Certification Comparison of Top 3 CLIA Deficiencies 1995 vs Quality Assurance Plan Manufacturer's Instructions Lab Director CLIA DEFICIENCIES

11 Costs incurred for Research Laboratory to become CLIA certified: Cost increases that will be incurred by individual laboratories will largely depend on their current operations. Those laboratories that are following what is generally referred to as good laboratory practice may see only minimal cost increases as a result of becoming CLIA certified. Those laboratories that do not follow such practices may experience significant increases in the costs of their operations. 11

12 The HHS Program Decision A previous decision was made by HHS to require non-clia certified laboratories participating in various research projects to have CLIA certification in order to report patient specific results. Not requiring research laboratories to follow the minimum requirements under CLIA for laboratory operations may endanger patient safety, and potentially allow the patient to receive a test result that is not accurate or reliable. With non-clia certified research laboratories, a patient will not know that their test result was generated by a laboratory with no guarantee of quality or safety. 12

13 Advantages of Returning Patient Specific Results from a Research Laboratory Promote research laboratory participation; Promote participation by volunteers who would be attracted to the potential to obtain test results from all labs, not just CLIA-certified labs. Ensure that all participants can access their test results (not just those whose tests were done by CLIA labs). 13

14 Disadvantages of Returning Patient Specific Results from a Research Laboratory CMS is unable to find a means to report non-clia research laboratory results that does not undermine the protections afforded by the CLIA regulations for patient health and safety. There is no basis to conclude that participants (or others) would not use the test data for healthcare purposes, nor is it likely that there could ever be reasonable controls to prevent such a use. There is considerable danger that many laboratories would begin to claim that they are only conducting research and that their patients are participating for non-healthcare purposes. 14

15 Committee Considerations: 1. What is the potential benefit and detriment in requiring CLIA certification for research laboratories? 2. How would the absence of CLIA certification protect patient health and safety? 3. How would research laboratories ensure accurate and reliable test results in the absence of having CLIA certification? 4. If non-clia certified research laboratories can report patient specific results, what would be the possible impact on laboratories currently CLIA certified? 15

16 Summary CMS/SCG Mission: To assure health care quality and safety for the U.S. public through survey, certification, and public information of providers' and suppliers' quality of care. 1. CLIA aims to ensure the consistency, standardization, and reliability of accurate results regardless of where the testing is performed. 2. By regulating the laboratories providing patient specific results, CMS fulfills its mission to protect the health and safety of all patients. 16

17 A Decade Later, a Patient Finds Out Her Genetic Test Was Wrong Should scientists give results to participants in research studies if they haven t been validated in a clinical lab? AUTHOR: SARAH ZHANG PUBLISHED: MAY 11, 2017 SALT LAKE CITY 17