Point of Care Testing

• Point of care testing is also known as what?

  bedside, alternative, near-patient, decentralized, or axillary testing
• Point of Care Testing: ANALYTICAL TESTING activities provided within the institution but performed outside the physical facilities of the clinical laboratory.
• What is the main regulating body in the US regarding POCT devices?

  Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)
• Test complexities is determined by the testing characteristics such as?

  Stability of the reagent, preparation of the reagent, operational steps, calibration, and QC
• What are the 4 COMPLEXITY CATEGORIES?

  Waived testing, moderately complex testing, highly complex testing, and provider-performed microscopy (PPM) tests
• What complexity category are considered SIMPLE procedures with LITTLE CHANCE of NEGATIVE outcomes if performed inaccurately?

  Waived testing
• What complexity category is MORE COMPLEX than waived tests but usually AUTOMATED such as blood counts and routine chemistries?

  Moderately complex testing
• Most POCT devices are included in what complexity category?


  Moderately complex testing
• Moderately complex testing are NOT modified manufacturer’s instructions, reagents are READILY AVAILABLE.
• What complexity category are usually nonautomated or complicated tests requiring considerable judgement?

  Highly complex testing
• Give examples of tests that requires highly complex testing?

  microbiology or crossmatching
• What complexity category includes tests that are performed only by physician’s assistants, nurse, practitioners, midwives, physicians, and dentists during a patient’s examination?


  Provider-performed microscopy (PPM) tests
• PPM uses slide examinations of what?

  freshly collected body fluids