CONTINUING EDUCATION :: POCT
Understanding the difference between waived and non-waived testing:
Before the Clinical Laboratory Improvement Amend- ments of 1988 (CLIA), there was little to no testing being performed outside of the main clinical labora- tory. Since CLIA, the number of CLIA-approved waived tests has risen dramatically, from 8 to over 1,400. People often use the terms “point-of-care testing” and “waived testing” synonymously. However, this is not an accurate statement. Point-of-care testing also includes non-waived testing, which is divided into two categories: moderate-complexity testing (including provider-performed microscopy) and high-complexity testing. It is important to understand the difference between waived and non-waived testing and how each applies to POCT. This will ensure that compliance with state and federal regulations and accreditation require- ments are met. CLIA waived testing: Tests with simple procedures that pose little chance of a negative outcome if the test is performed inaccurately/incorrectly. Requirements:
• Must have a CLIA certificate of waiver. • CLIA does not require policies for assessing person- nel competency for waived testing.
• Even though CLIA has no specific requirements for personnel performing waived testing, there needs to be a way to ensure that patient test results are correct to assist in making an accurate patient diagnosis.
• Testing personnel must follow all manufacturers’ instructions.
• Usually requires staff to have minimal education, i.e., high school diploma
• If a laboratory is accredited by CAP or TJC, it may need to consult their standards. Some examples of waived tests:
• Bedside glucose • Urinalysis • Pregnancy • Rapid strep
be flagged by the data manager and held for investigation by the POCC.3
Quality control results from all devices and internal and external controls for lateral flow tests must also be monitored and reviewed for compliance. For devices with quantitative results, the QC results download to the data management system, and the POCC can review individual results or view QC using Levey-Jennings (L-J) charts. L-J charts allow the reviewer to look for trends and shifts in QC and address issues accordingly (Figure 2). The L-J charts also show the statistical analysis for each device, including range, mean, standard deviation, and percent coefficient of variation (%CV). The reviewer can mark individual results and charts as reviewed and add additional review notes. The POCC can also handle any QC outliers and ensure QC passed prior to running patient tests.4 When asked for by an accreditation inspector or surveyor, the L-J charts are easily accessible to show proof of compli- ance. The POCC must also review qualitative QC to ensure
12 AUGUST 2022
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CLIA non-waived testing: Moderate complexity, high complexity, and provider-performed micros- copy (PPM). Requirements: Personnel performing non-waived testing must have documented initial training by a technical consultant (TC) prior to patient testing. A TC must have a bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology with at least two years’ experience in non-waived testing. The TC’s training and experience must include the discipline(s) in which the individual is providing consultation. Evaluating and documenting competency of person- nel responsible for testing is required at least semian- nually during the first year the individual tests patient specimens (once at six months, once at one year). Thereafter, competency assessment must be per- formed at least annually through the following: • Direct observations of routine patient test performance
• Monitoring the recording and reporting of test results • Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
• Direct observations of performance of instrument maintenance and function checks – quality control
• Assessment of test performance through testing pre- viously analyzed specimens (proficiency samples)
• Assessment of problem-solving skills (quizzes) Personnel performing non-waived testing are usu- ally required to have higher education (beyond HS diploma) and in some cases licensure (Registered Nurse, Respiratory Therapist, Doctor of Osteopathy, or Medical Doctor). Some examples of non-waived testing:
• Blood gas • Activated clotting time (ACT) • Fern test – PPM
the external controls are being performed successfully. For internal QC performed with the patient test, any failures can be flagged and those results held so that they do not go into the patient’s medical record. Failed QC results, whether quantita- tive or qualitative, can alert the POCC to possible issues with a device or the need for retraining if a specific operator continues to struggle with performing QC. Some devices require linearity or calibration verification upon initial implementation, and most moderately complex devices require linearity every six months. By having POCT devices connected to a data manager, the operators can perform the linearity testing and those results download to the data manager for review by the POCC/TC. The linearity results are graphed, and statistical data is generated, including slope, Y-intercept, and percent correlation coefficient (Figure 3). The POCC can review the linearity charts, verify reportable ranges and adjust a range if needed. In a large system with many connected devices requiring linearities, it’s crucial for the POCC to be able to have one place to review and store those
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