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Point of care testing

Point-of-care testing (POCT) is defined as medical testing at or near the site of patient care. The goal of POCT is to collect the specimen and obtain accurate results in a very short period of time at or near the location of the patient. POCT is often accomplished through the use of transportable, portable, and handheld instruments

The main aim, and benefit, of POCT is to bring the test conveniently and immediately to the patient. This increases the likelihood that the physician and care team will receive the results quicker, enabling clinicians to support the timely diagnosis, monitoring and treatment of patients.

All clinics performing POCT tests must notify the Clinical Safety Coordinator when they plan to begin testing or add additional tests.

For purposes of quality and performance, UT Physicians (UTP) is standardizing POCTs so that all the clinics use the same product.

CLIA Categories / Tests Performed at UT Physicians (UTP)

  1. Waived – simple tests with a low risk for an incorrect results. UTP clinics performing Waived tests are added to one UTP CLIA certificate, must follow manufacturer’s instructions, perform, Quality Control and document on associated logs, and participate in Proficiency Testing. Quality Control Logs must be submitted monthly to the Clinical Safety Coordinator for review.

    A test’s Waived designation is specific to each product and type of sample collected. Below is a list of Waived tests performed at UTP clinics with the recommended product.

    1. Rapid Influenza A/B – BD Veritor Influenza
    2. Rapid Strep A – BD Veritor Strep A
    3. Rapid RSV – BD Veritor RSV
    4. Urinalysis dipstick – Siemens 10SG Strips with Siemens Clinteck Plus Analyzer
    5. hCG pregnancy – (not standardized at this time)
    6. Fingerstick blood glucose – HemoCue Glucose 201
    7. Hemoglobin A1c – DCA Vantage or Afinon AS 100
    8. Infectious Mononucleosis – not standardized at this time
    9. PT/INR – not standardized at this time

  2. Provider-Performed Microscopy (PPM) - PPM procedures are certain moderate complexity microscopy tests commonly performed by health care providers during patient office visits.

    1. Wet mounts, including preparations of vaginal, cervical or skin specimens
    2. All potassium hydroxide (KOH) preparations
    3. Pinworm examinations
    4. Fern test
    5. Post-coital direct, qualitative examinations of vaginal or cervical mucous
    6. Urinalysis, microscopic only or in combination with dipstick; two or three glass test
    7. Fecal leukocyte examination
    8. Semen analysis; presence and/or motility of sperm excluding Huhner
    9. Nasal smears for eosinophils.

  3. Moderate and High Complexity
    For moderate and high complexity tests, the FDA evaluates each new commercial test system during the premarket approval process by scoring seven criteria as described in the CLIA regulations. Additional requirements and accreditation is required.

    Some clinics perform CBC tests, and are responsible for meeting all the requirements of CLIA and accreditation. EHS does not currently have a program to assist clinics obtaining a certification above PPM/Waived.

All Quality Control (QC) Logs can be found on Clinical Resources.