MLAB 2401: C LINICAL C HEMISTRY K ERI B ROPHY -M ARTINEZ Point of Care Testing 1

P OINT OF C ARE T ESTING 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 2

P OINT OF C ARE T ESTING 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, Overseen by the FDA and CMS 3

P OINT OF C ARE T ESTING 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. 4

P OINT OF C ARE T ESTING 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. 5

P OINT OF C ARE T ESTING 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 FDA’s website 6

P OINT OF C ARE T ESTING 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. 7

P OINT OF C ARE T ESTING 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. 8

P OINT OF C ARE T ESTING 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 9

P OINT OF C ARE T ESTING 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 10

P OINT OF C ARE T ESTING 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. 11

P OINT OF C ARE T ESTING : A DVANTAGES Fast delivery of results Small sample volume Overall low cost Portable 12

P OINT OF C ARE T ESTING : D ISADVANTAGES Quality of results Management and documentation issues 13

P OINT OF C ARE T ESTING A PPLICATIONS 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 14

P OINT OF C ARE T ESTING 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. 15

R EFERENCES Bishop, M., Fody, E., & Schoeff, l. (2010). Clinical Chemistry: Techniques, principles, Correlations. Baltimore: Wolters Kluwer Lippincott Williams & Wilkins. cfClia/testswaived.cfm?start_search=C