MLAB 2401: Clinical Chemistry Keri Brophy-Martinez

1. MLAB 2401: Clinical ChemistryKeri Brophy-Martinez Point of Care Testing

2. Point of Care Testing • Analytical patient - testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratories • Alternative names • Bedside testing • Ancillary testing • Off-site testing • Waived testing

3. Point of Care Testing • CLIA 88 • In 1988, Congress passed the Clinical Laboratory Improvement Act. • Regulations were not written until 1990, comments were added, and changes were made. • Implementation was September 1, 1992. • Overseen by the FDA and CMS

4. Point of Care Testing • Types of Classified laboratories • Those performing waived tests only • Those performing moderate complex testing • Has allowance for “PPMP”: provider performed microscopy procedures • Those performing highly complex tests. • Classification based on difficulty or complexity of test procedures and level of training required to accurately perform the test. • Laboratory standards differ for each of the categories.

5. Point of Care Testing • Waived – • Lab must have CLIA waiver certificate • No certification requirements of those performing the test • No proficiency testing • No minimum training for testing personnel • Criteria of a waived test: if the results of the test are in error, no immediate danger exists for the patient.

6. Point of Care Testing • Examples of waived tests • several methods for hemoglobin determination • blood glucose by meters approved for home use • Hb A1c • fecal occult blood • spun hematocrit • ovulation tests (by color comparison) • urine pregnancy tests • urine dipstick • esr • PT • immunoassay for mononucleosis • FDA’s website for waived testing

7. Point of Care Testing • Moderately Complex Testing • Lab must have Certificate of Accreditation • Includes many manual procedures with limited steps and preparation OR automated analyses that do not require operator intervention during the analytical process. • Requires • Proficiency testing. • Responsible person (oversight structure) for the technical and scientific oversight of the testing. • Personnel have specific training and orientation to perform the test. Continuing competency must be documented. • Minimum high school diploma • Lab must have lab director / technical consultant.

8. Point of Care Testing • Highly complex testing • Lab must have Certificate of Accreditation • Must meet all criteria of moderately complex testing lab • Personnel must have minimum Associate Degree or equivalent. • Like the moderate complex level, Lab must have lab director / technical consultant.

9. Point of Care Testing • Highly complex testing • Testing can include procedures • Requiring considerable decision making, complex judgment & analysis of results to provide interpretation. • Specialized scientific and technical knowledge required. • Test may require special preparation of reagents, extensive technical and quality control measures

10. Point of Care Testing • Most hospitals perform moderate to highly complex testing and must: • follow hiring guidelines • participate in proficiency testing • maintain comprehensive record keeping • have established quality assurance programs • and are subject to government inspections

11. Point of Care Testing • Proficiency Testing (PT) • PT is mandated by CLIA for all labs performing moderate or high complexity testing as a method for evaluating performance quality by an external agency. • Process • Labs are provided with samples of analyte; values are known only to the testing program. • The lab analyzes the specimens in the same manner as patient specimens. • If a lab fails in a particular analyte, it will have a chance to reanalyze other specimens to prove its quality performance; if it fails in that area again, there is a possibility it will not be approved reimbursement from Medicare or Medicaid for that analyte.

12. Point of Care Testing: Advantages • Fast delivery of results • Small sample volume • Overall low cost • Portable

13. Point of Care Testing: Disadvantages • Quality of results • Management and documentation issues

14. Point of Care Testing Applications • Glucose • Highest volume • Likely the first application of POCT (home testing) • Instruments become very sophisticated and many maintain log of QC results. • Chemistries and Blood Gases • Coagulation testing • Activated clotting time - for monitoring heparin therapy • Hematology • Spun hematocrit - can have several opportunities for error, therefore being replaced by hemoglobin measurement

15. Point of Care Testing • POC Connectivity • To eliminate error due to transcription of results; most instruments now capable of electronically sending test data • Most significant recent development in POCT • Three components of connectivity: • Device: Instrument itself can store data. • Data management: Instrument uploads data to work station. • Interface: Data manager transmits test results to information system.

16. References • Bishop, M., Fody, E., & Schoeff, l. (2010). Clinical Chemistry: Techniques, principles, Correlations. Baltimore: WoltersKluwer Lippincott Williams & Wilkins. • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm?start_search=C • http://www.aculabs.com/news.htm