CLIA OVERVIEW

1.  CLIA OVERVIEW Virginia Wanamaker Deputy Director Division of Laboratory Services Centers for Medicare & Medicaid Services

2. CLIA OVERVIEW Impetus for Clinical Laboratory Improvement Amendment (CLIA) Deaths from inaccurately read Pap smears. Proliferation of �black box� technology with no oversight in physicians� offices. Subpart J includes the requirements for facilities and record and specimen retention. Every laboratory must have a facility whether permanent or temporary and every laboratory has records that must be retained. These are the structure requirements that we talk about in POD. This section also includes transfusion services. Neither the CLIA regulations or the laboratory cover the actual administration of transfusion of blood or blood products, but the requirements for transfusion will remain in CLIA until the regulations are updated in all the facility types that do give transfusions. Subpart J includes the requirements for facilities and record and specimen retention. Every laboratory must have a facility whether permanent or temporary and every laboratory has records that must be retained. These are the structure requirements that we talk about in POD. This section also includes transfusion services. Neither the CLIA regulations or the laboratory cover the actual administration of transfusion of blood or blood products, but the requirements for transfusion will remain in CLIA until the regulations are updated in all the facility types that do give transfusions.

3. CLIA OVERVIEW Congress passed the Law in 1988 Regulates all testing on humans for health purposes using minimum quality standards To ensure accurate testing regardless of location Includes research when results returned and specimens have unique ID Subpart J includes the requirements for facilities and record and specimen retention. Every laboratory must have a facility whether permanent or temporary and every laboratory has records that must be retained. These are the structure requirements that we talk about in POD. This section also includes transfusion services. Neither the CLIA regulations or the laboratory cover the actual administration of transfusion of blood or blood products, but the requirements for transfusion will remain in CLIA until the regulations are updated in all the facility types that do give transfusions. Subpart J includes the requirements for facilities and record and specimen retention. Every laboratory must have a facility whether permanent or temporary and every laboratory has records that must be retained. These are the structure requirements that we talk about in POD. This section also includes transfusion services. Neither the CLIA regulations or the laboratory cover the actual administration of transfusion of blood or blood products, but the requirements for transfusion will remain in CLIA until the regulations are updated in all the facility types that do give transfusions.

4. CLIA OVERVIEW Final Regulations published Feb. 1992 Five major quality standards based on test complexity The more complex the test, the more stringent the standards Subpart K includes those requirements that describe how a laboratory must function. They are in a logical order starting with the test request and ending with the reporting of the test results. We certify laboratories by specialty and subspecialty. For that reason, Subpart K lists the condition statements for the s/s immediately following the introduction. Each one of these conditions lists those requirements that must be met to meet each specific condition. Note that each s/s condition now includes all the general lab systems, pre, analytic and post requirements for that particular condition to be met. In the past, the specialty and subspecialty conditions were listed in the middle of the quality control section were applicable only to quality control. With this organization, all the process� for each s/s are included (pre.ana.post) Granted all the requirements are not together, but this is better than the condition statement referring requirements throughout the regulation. For example in the old reg, when citing the condition of Bacti out of compliance- media requirements were listed prior to the Bacti condition and quality control and susceptibility were cited after the condition statement. Quality assurance and record keeping in PTM were not included as a requirement for the condition of Bacti, so could not be included in the basis for the condition of Bacti being not met Note that the conditions are in the same order as on the 1557. Subpart K includes those requirements that describe how a laboratory must function. They are in a logical order starting with the test request and ending with the reporting of the test results. We certify laboratories by specialty and subspecialty. For that reason, Subpart K lists the condition statements for the s/s immediately following the introduction. Each one of these conditions lists those requirements that must be met to meet each specific condition. Note that each s/s condition now includes all the general lab systems, pre, analytic and post requirements for that particular condition to be met. In the past, the specialty and subspecialty conditions were listed in the middle of the quality control section were applicable only to quality control. With this organization, all the process� for each s/s are included (pre.ana.post) Granted all the requirements are not together, but this is better than the condition statement referring requirements throughout the regulation. For example in the old reg, when citing the condition of Bacti out of compliance- media requirements were listed prior to the Bacti condition and quality control and susceptibility were cited after the condition statement. Quality assurance and record keeping in PTM were not included as a requirement for the condition of Bacti, so could not be included in the basis for the condition of Bacti being not met Note that the conditions are in the same order as on the 1557.

5. CLIA OVERVIEW Surveys: Performed biennially and are announced The first survey is information-sharing unless risk to patient safety is found Survey process looks at outcomes�results Lab is given credit for what they do right

6. CLIA OVERVIEW Labs must enroll and meet all major CLIA quality requirements: Personnel PT Quality control (Analytic Systems) Patient test management (Pre Analytic and Post Analytic Systems) Facility Administration Quality Assessment The preanalytic system includes those first steps of the quality system process of test requests, specimen submission, handling and referral and the same assessment requirements as in gen lab systems to monitor, assess and correct as necessary.The preanalytic system includes those first steps of the quality system process of test requests, specimen submission, handling and referral and the same assessment requirements as in gen lab systems to monitor, assess and correct as necessary.

7. How does CMS look at laboratories? Outcome-Oriented Survey Process

8. CLIA Surveys: State Agency Med. Techs. trained by CMS Approved accrediting organizations with equivalent standards; e.g. CAP, JCAHO Educational, outcome-oriented with QA focus Data indicates improved lab performance over time with more labs than ever enrolled in CLIA CLIA OVERVIEW (This is the QA (Quality Assessment) piece). There are equivalent assessment requirements in each of the other systems. How do you evaluate and know your policies are effective?(This is the QA (Quality Assessment) piece). There are equivalent assessment requirements in each of the other systems. How do you evaluate and know your policies are effective?

9. CLIA OVERVIEW Survey Process: Perform entrance interview Tour lab Observe testing Interview personnel The introduction to the Analytic Systems reads as follows. The introduction to the Analytic Systems reads as follows.

10. CLIA OVERVIEW Survey Process: Review records, data/information Assess outcomes and determine compliance Conduct exit conference and generate survey report Lab develops plan of correction if problems found The introduction to the Analytic Systems reads as follows. The introduction to the Analytic Systems reads as follows.

11. CLIA OVERVIEW CLIA State Surveyors: Professional and knowledgeable about CLIA, laboratory practices and quality assessment Evaluate lab�s overall ability to provide accurate results rather than individual standards Receive periodic training by CMS and experts Those sections mentioned in the introduction include all of the following sections. Titles look pretty similar to the old reg. High complexity.Those sections mentioned in the introduction include all of the following sections. Titles look pretty similar to the old reg. High complexity.

12. CLIA OVERVIEW Without specific G.T. training a CLIA surveyor can: Review lab director�s qualifications and responsibilities Evaluate QC, instrument maintenance and analytical test validation and PT data Interview testing personnel: observe test procedures Those sections mentioned in the introduction include all of the following sections. Titles look pretty similar to the old reg. High complexity.Those sections mentioned in the introduction include all of the following sections. Titles look pretty similar to the old reg. High complexity.

13. CLIA OVERVIEW Without specific G.T. training a CLIA surveyor can: Verify specimen integrity, identification, handling, audit trail, confidentiality, etc. Assess lab�s plan to assure accuracy internally and externally and solve problems; check turnaround time Assist the lab to meet applicable CLIA requirements. Those sections mentioned in the introduction include all of the following sections. Titles look pretty similar to the old reg. High complexity.Those sections mentioned in the introduction include all of the following sections. Titles look pretty similar to the old reg. High complexity.

14. CLIA COMPLIANCE for GENETIC TESTIANG CLIA experience with G.T. research labs: Much of what lab does to verify test works and results are correct facilitates meeting CLIA Existing documentation and data are useful Organizational materials are acceptable: e.g. job descriptions, safety plans, etc. There are G.T. research labs in compliance with CLIA!! NOT NEW!NOT NEW!

15. CLIA COMPLIANCE for GENETIC TESTING Quality control Examples of alternative control procedures Split samples with another lab Include previously tested patient samples as surrogate controls Test each patient specimen in duplicate Test multiple specimen types from same patient NOT NEW!NOT NEW!

16. CLIA COMPLIANCE for GENETIC TESTING Proficiency Testing (PT) No PT program samples available At least twice a year lab needs to verify accuracy of test Some examples to accomplish verification Blind testing of materials with known values Correlation of patient results with clinical symptoms Split samples with another laboratory NOT NEW!NOT NEW!

17. QUALITY ASSESSMENT PROGRAM Establish and follow policies/procedures addressing ongoing QA activity Take corrective actions as necessary Review their effectiveness Revise policies/procedures as necessary to prevent recurrence Communicate to staff Document all assessment activities NOT NEW!NOT NEW!

18. GENETIC TESTING UPDATE Currently CLIA has no specific standards addressing genetic testing Molecular amplification procedures are included in Final Quality System Rule Notice of Proposed Rulemaking (NPRM) under development by CDC and CMS NPRM is on CMS regulation schedule NOT NEW!NOT NEW!

19. CLIA and HIPAA HIPPA Privacy Rule yields to CLIA CLIA limits release of test results by a laboratory only to persons authorized under State law to receive test results CLIA yields to State requirements NOT NEW!NOT NEW!

20. MYTH and FACT MYTH A CLIA certified lab may send a specimen to a research lab. If the CLIA lab confirms the test results of the research lab, then the research lab does not need a CLIA certificate. FACT Both labs need CLIA certificates. The CLIA certified lab has referred a specimen to another lab that should also be CLIA certified. The organization follows the flow of a patient specimen through the laboratory. From test request and specimen collection to test reporting. The organization follows the flow of a patient specimen through the laboratory. From test request and specimen collection to test reporting.

21. MYTH and FACT MYTH If a physician sends a patient sample to a foreign lab, it is considered practice of medicine and the foreign lab does not have to be CLIA certified. FACT It does not matter whether the physician or a CLIA lab sends the specimen, it is laboratory testing and falls under CLIA. The foreign lab needs to be CLIA certified. The organization follows the flow of a patient specimen through the laboratory. From test request and specimen collection to test reporting. The organization follows the flow of a patient specimen through the laboratory. From test request and specimen collection to test reporting.

22. MORE INFORMATION www.cms.hhs.gov/clia CLIA Application State Agency Contacts Guidelines for Surveyors and Laboratories General Information about CLIA The organization follows the flow of a patient specimen through the laboratory. From test request and specimen collection to test reporting. The organization follows the flow of a patient specimen through the laboratory. From test request and specimen collection to test reporting.