1. Who makes up all these rules?? A discussion on Regulatory Agencies and how they relate to each other and our lab.

3. Accreditation Vs License

4. Accreditation vs. License Accreditation: The act of accrediting or the state of being accredited, especially the granting of approval to an institution by an official review board after the institution has met specific requirements. Licensure: the state or condition of having a license granted by official or legal authority to perform procedures not permitted by persons without such a license

5. Accrediting Agencies: JCAHO CAP COLA

6. Licensing Agencies: CLIA’88- CMS State of Maryland Other State Agencies

7. And all those others: OSHA- Federal and State Baltimore Fire Department Health & Safety Environmental Dept Department of Pathology CQI FDA AABB and so on and so on and so on…..

8. So whose rules do we follow?? –Laboratories are licensed to operate by CMMS (Centers for Medicare and Medicaid Services) under CLIA’88 Act found in Federal Register Part 493. –CMMS may deem a laboratory to meet all applicable CLIA’88 requirements through accreditation by a private non-profit organization (JCAHO) and/or a State accredit ting agency (Maryland State). –Agencies given deemed status must have requirements that are equal to or more stringent the CLIA’88 condition level requirements.

9. Following the Basics Personnel requirements Leadership Quality Systems Quality Control Proficiency Testing Patient Safety

10. Personnel Requirements Training guidelines: - period of time - direct supervision - specific goals Competency testing: - defined frequency - cover all aspects Continuing Education: - number of hours required -must provide opportunity

11. Leadership The Laboratory Director takes ultimate responsibility for all activities within the clinical laboratory. Oversight can be designated by the Laboratory Director to others within the lab: Associate Directors Residents and Fellows Supervisors and Lead Techs QC Techs Education Tech QA/PI Tech

12. Quality Systems The laboratory is required to have a program to monitor performance as deemed by the Laboratory Director. 1- QA Monitors- take a pulse of performance. 2- PI- mechanisms to improve performance 3- Mechanism to measure meeting of customer needs

13. Quality Control Define type, frequency and levels of quality control minimumally meeting Manufacturers recommendations. Regular review of results Documentation of actions taken when QC is not within acceptable limits. Notification of Laboratory Director

14. Proficiency Testing With the exception of Waived Test, each analyte performed in the laboratory must be enrolled in a proficiency testing program. Analytes for which there is no proficiency testing program or analytes receiving an ungraded score must perform one of the following 2 times per year: -Split shared sample analysis with another laboratory performing the same analyte testing. -Performance of NIST standards or similar with certified results. -Performance of calibrator material with known values across the reportable range of the test.

15. Patient Safety National Patient Safety Goals Patient Safety Goal 1 Use of 2 unique patient identifiers Patient Safety Goal 2 Improve communication between care providers Patient Safety Goal 7 Reduce the risk of care provider induced infections

16. Resources CAP (College of American Pathologists): http://www.cap.org/ http://www.cap.org/ COLA ( Commission on Office Laboratory Accreditation): http://www.cola.org/default.asphttp://www.cola.org/default.asp JCAHO (Joint Commission on Accreditation of Healthcare Organizations): http://www.jcaho.org/ http://www.jcaho.org/ MD State Office of Health Care Quality: http://www.dhmh.state.md.us/ohcq/ http://www.dhmh.state.md.us/ohcq/ MD State Health Services Cost Review Commission: http://www.hscrc.state.md.us/http://www.hscrc.state.md.us/

17. More Resources Federal Government Agencies: CMS (Center for Medicare and Medicaid Services): http://www.cms.hhs.gov/CLIA/ http://www.cms.hhs.gov/CLIA/ FDA - OIVD (Office of In Vitro Diagnostic Device Evaluation and Safety): http://www.fda.gov/cdrh/oivd/laboratory.html#1 http://www.fda.gov/cdrh/oivd/laboratory.html#1 FDA – Patient Safety News: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/in dex.cfm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/in dex.cfm Healthcare Standards: NCCLS (National Committee on Clinical Laboratory Standards): http://www.nccls.org/http://www.nccls.org/