Laboratory Regulations Questions and Answers

Laboratory Regulations Questions and Answers Clinical Laboratory Improvements Amendments (CLIA) - a Public Law passed in 1988 that establishes quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results - every site testing materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease is subject to the law Centers for Medicare and Medicaid Services (CMS) - an organization that is responsible for registering laboratories for CLIA certificates, collecting fees, on-site and self-inspection surveys, surveyor guidelines and training (for enforcement actions when needed), approving proficiency testing providers, accrediting professional organizations, and exempting states Food and Drug Administration (FDA) categorizes test methods for complexity; waived, moderate complexity, and high complexity Waiver Certificate - a CLIA certificate that permits a site to perform only those tests methods identified as waived Provider-Performed Microscopy Procedures (PPMP) Certificate - a CLIA certificate issued to a laboratory for physicians, midlevel practitioners, or dentists to perform PPMP procedures, or those tests on specimens collecting during a physical examination along with waived tests Registration Certificate - a CLIA temporary certificate issued to enable laboratories to conduct waived, moderate, and/or high complexity laboratory testing while waiting to be inspected and issued a certificate of compliance Compliance Certificate - a CLIA permanent certificate issued to inspected and approved labs to conduct waived, moderate, and/or high complexity laboratory testing - inspections by an agent of CMS Accreditation Certificate - a CLIA certificate issued to laboratories seeking accreditation by a CMS-deemed professional organization - are approved to conduct waived, moderate, and/or high complexity laboratory testing - laboratories must pay both the professional organization and CLIA fees - are inspected every two years by the professional organization - CMS still has the right to a quality check re-inspect to up to 5% of testing sites accredited by deemed organizations Waived Testing Status may be granted to: 1) any test listen in the regulation, 2) any test system in which the manufacturer provides scientifically valid data to meet the waiver criteria, and 3) test systems cleared by the FDA for home use - use such simple and accurate methodologies that the likelihood of erroneous results is negligible - CMS inspectors responsible for determining adherence to CLIA regulations will not inspect waived testing facilities unless a specific complaint has been lodged or fraudulent activities are suspected Moderate Complexity Testing -Each lab test system/methodology graded for level of complexity 1-3 (ascending complexity) on: 1) Knowledge 2) training and experience 3) reagents and materials preparation 4) characteristics of operational steps 5) calibration, QC, and PT materials 6) test system troubleshooting and equipment 7) interpretation and judgement -test systems receiving a total score of 8-12 High Complexity Testing -Each lab test system/methodology graded for level of complexity 1-3 (ascending complexity) on: 1) Knowledge 2) training and experience 3) reagents and materials preparation 4) characteristics of operational steps 5) calibration, QC, and PT materials 6) test system troubleshooting and equipment 7) interpretation and judgement -test systems receiving a total score of 13+ Director - necessary position for sites performing moderate complexity testing - can range from a physician to someone with a bachelor's degree in medical technology/CLS or a degree in chemical, physical, or biological science and having two years of lab training/experience and two years of lab supervisory experience - responsible for all aspects of lab operation and administration - responsible for ensuring that all duties are properly performed - when director is a physician, typically also serves as the clinical consultant Technical Consultant - necessary position for sites performing moderate complexity testing - qualifications range from being a clinician to possessing a bachelor's degree in chemical, physical, biological, or medical technology/CLS and one year of experience - establishes the quality standards Clinical Consultant - necessary position for sites performing moderate complexity testing and high complexity testing - must be a clinician or have a doctorate in chemical, physical, biological, or MT/CLS science - serves as the liaison between the lab and its customers - must be qualified to consult with clinicians and patients, and give opinions concerning the diagnosis, treatment, and management of patient care Testing Personnel - necessary position for sites performing moderate complexity testing - minimum requirements include a high school education (or equivalent), plus appropriate director-approved training, and continued (at least yearly) competency assessment - actually perform the POCT Director - necessary position for sites performing high complexity testing - must be a licensed doctor of medicine, osteopathy, or podiatry; have a doctorate in chemical, physical, biological, or medical technology/CLS - must be certified by a board approved by the Heath and Human Services (HHS) - responsible for all aspects of lab operation and administration Technical Consultant - necessary position for sites performing high complexity testing - qualifications range from being a clinician to possessing a bachelor's degree in chemical, physical, biological, or medical technology/CLS and one year of experience - establishes the quality standards by selecting and monitoring methods and instrumentation, and evaluating and documenting the competency of its personnel at least once per year after the first year of employment General Supervisor - necessary position for sites performing high complexity testing - requirements range from being a clinician, to persons possessing an associate degree in laboratory science or medical laboratory technology, and two years of laboratory training and experience - provides day-to-day supervision of testing personnel and reporting of results Testing Personnel - necessary position for sites performing high complexity testing - must possess an associate degree in laboratory science or medical laboratory technology, or education and training equivalent to an associate degree - actually perform the POCT Proficiency Testing (PT) - plays a key role in assessing the internal quality for CLIA-regulated analytes in test sites performing moderate and/or high complexity testing - participation in this is a requirement for maintaining the CLIA certificate of compliance; must be enrolled in a CMS-approved PT program - CLIA requirements identify minimum performance limits for each analyte - testing sites failing the same analyte in two of three consecutive PT events can be subject to sanctions ranging from being required to submit a plan of correction to mandatory suspension of testing for the failed analyte Quality Systems for Nonwaived Testing - specified requirements that are applicable to both moderate and high complexity testing categories - published by the CMS to the CLIA - follows the path of patient specimens through the testing process - pre analytical, analytical, and post analytical Pre-Analytical Requirements for Nonwaived Testing - specify the info needed on each test request and the policies and procedures that must be in place for specimen submission, handling and referral - concerned with maintaining sample integrity and positive patient identification throughout the testing process Analytical Requirements for Nonwaived Testing - address the procedure manual, all components associated with a particular test system/instrument, verification of methods' performance specifications before routine implementation, maintenance and function checks, calibration and calibration verification, and quality control procedures - also includes additional requirements for specialty testing such as bacteriology and immunohematology Post-Analytical Requirements for Nonwaived Testing - include the systems that need to be in place to ensure accurate, reliable, and timely-reported patient data along with the needed information on the test report