CLASSIFICATION: Position Paper
STATUS: Approved Revision June 30, 2022

Over the last several decades, two major themes have arisen in healthcare; costs and accessibility. One pathway introduced and expanded upon to address these issues is point of care testing (POCT). In many hospital environments, POCT is now an essential cornerstone in the diagnostic pathway. It can also be found in physician offices, urgent care centers, free standing emergency rooms, walk in clinics, and community health fairs. This expansion of POCT has provided rapid diagnostic information and easily accessible results delivering needed medical guidance for inpatient and outpatient populations. However, as testing expands in the hospital and community environment, it is essential that POCT have appropriate oversight to avoid incorrect diagnosis and inappropriate treatment.

As healthcare costs and accessibility remain top priorities for health care systems and point of care testing continues to expand beyond hospital borders, the following questions are raised for consideration:

• What role should medical laboratory professionals take in the performance of point of care testing?
• What role should medical laboratory professionals take in the management of this testing?
• How can medical laboratory professionals assure the public that the testing is clinically relevant and accurate?

Background

Point of care testing, or patient bedside testing, refers to testing performed outside of the main laboratory and in proximity to the patient. These testing platforms have significantly expanded to include more comprehensive test menus and highly advanced instrumentation since their first introduction in the 1980s. With this growth, many tests available as point of care are no longer CLIA waived; many are considered moderate.

A major driver for the expansion of POCT is the economic benefit of having rapid test results which can potentially lead to reduced hospital stays, a reduction in hospital admissions, and fewer clinic visits. Procedures that were previously performed during inpatient settings have been moved to outpatient environments allowing them to be performed in an ambulatory setting. Having POCT available in these locations facilitates testing without a clinical laboratory on site.

As the scope of POCT has grown, so must the umbrella of oversight. Regardless of the testing location, nor the complexity of testing that is being performed, it must have quality oversight as required by the regulatory standards that govern the testing. To assure POCT reliability, accuracy, and quality, the medical laboratory professional’s expertise as an active, consultative member for these testing platforms is crucial regardless of the testing site.

Rationale

The Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) are regulations that encompass all phases of the testing process ranging from pre-analytical procedures to post-analytical procedures. Adherence to CLIA ’88 regulations builds quality into the testing process and ensures patient safety. Every part of the testing process is regulated to ensure that accurate and reliable results are reported.

A laboratory, as defined by CLIA ’88, is “a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or treatment of, or the assessment of the health of human beings. These examinations include procedures to determine, measure, or otherwise describe the presence of various substances or organisms in the body.”

The College of American Pathologists (CAP) defines Point of Care Testing (POCT) as “those analytical test sites or services within the institution and operated or performed outside of the physical facilities of the clinical laboratories.” CAP does not exempt any tests or testing sites from the Standards. Therefore, all testing is subject to the same standards regardless of test level or testing site.

Technological advances have made it feasible for non-laboratory staff to perform the testing in a variety of settings. To understand the scope of testing, according to the Division of Clinical Laboratory Improvement and Quality Centers for Medicare and Medicaid Services, as of January 2022, of the 234,594 CLIA licenses held, 96% of facilities licensed to perform testing are located outside of a hospital setting. The following amount and types of institutions are licensed to perform testing (refer to Appendices A and B):

• 131,238 at Physician Offices (POLs)
• 37,905 at Other
• 25,709 at Pharmacies
• 15,734 at Skilled Nursing Facilities
• 14,754 at Home Health Agencies
• 9,254 at Hospital

Of the 234,584 CLIA Laboratories, 80% are Certificate of Waiver, 9% PPM, 6% Certificate of Compliance, 5% Certificate of Accreditation (refer to Appendix C). According to this data, only 11% of all testing facilities are guaranteed a biennial inspection by regulatory authorities. The remaining 89% of testing facilities are not guaranteed inspections.

In the Physician Operated Labs (POLs), where 131,238 CLIA licenses are issued, 70% of CLIA licenses are Waived, 18% Provider Performed Microscopy (PPM), 8% Certificate of Compliance, and 4% Certificate of Accreditation (Refer to Appendix D). Point of Care testing is widely waived testing; however, some test systems allow for moderate complexity testing or high complexity testing. PPM is treated as moderate complexity testing with differences in CLIA personnel requirements, test menu options, and exclusion from routine inspections. Test complexity levels are determined by The Food and Drug Administration (FDA). The FDA reviews manufacturer’s applications for test system waiver. For non-waived tests, the FDA determines the test’s complexity by reviewing the package insert test instructions and uses a graded scorecard to categorize a test as moderate or high complexity. Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria on the scorecard. The seven criteria include: knowledge, training and experience, reagents and materials preparations, characteristics of operational steps, calibration/quality control/proficiency testing materials, test system troubleshooting/equipment maintenance, and interpretation and judgment. A score of 12 or less yields a moderate complexity designation while scores above 12 will yield a high complexity designation.

CLIA defines waived tests as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” There are minimal requirements and oversight of waived testing. CLIA only requires an institution to enroll in the CLIA program by obtaining a certificate, paying the certificate fee every two years, verifying that they will follow the manufacturer’s instructions for the waived tests performed, and notifying their State Agency of any changes in ownership, name, address, or Laboratory Director within 30 days, or if they wish to add more complex testing. CLIA waived sites do not undergo routine inspections each year. Due to limited regulatory oversight, it is critical to employ a medical laboratory professional as a Technical Consultant to assure testing quality.

Non-waived tests include those in the Provider Performed Microscopy (PPM), moderate, and high complexity categories. Most non-waived POCT falls in PPM or moderate complexity categories, therefore high complexity will not be discussed. Provider Performed Microscopy (PPM) are certain moderate complexity microscopy tests commonly performed by health care providers during patient office visits. The PPM subcategory includes a limited set of microscopic evaluations listed in the CLIA regulations that are performed on samples such as urine, skin scrapings and excretions. CLIA offers a PPM certification option for this limited set of moderate complexity tests to accommodate the unique needs of health care providers in clinical settings. Only certain types of providers qualify as testing personnel for PPM tests under a PPM certificate, including physicians, dentists, and midlevel practitioners. Moderate testing is subject to regulations, setting minimum qualifications for all persons performing or supervising these tests, along with corresponding responsibilities for each position in the lab. These laboratories must also participate successfully in approved proficiency testing programs, which provide an external evaluation of the accuracy of the laboratory’s test results. Finally, moderate complexity laboratories must have systems and processes for monitoring testing equipment, procedures to ensure proper test performance and accurate results and an overall plan to monitor the quality of all aspects of the laboratory’s operation ongoing.

Inaccurate performance of testing can have negative impacts to patient care, regardless of the type of test (i.e., waived, PPM, moderate, or high complexity) performed. For example, common POCT waived tests such as PT/INR and glucose testing are used to monitor or alter patient medications. Tests used to detect human immunodeficiency virus (HIV), hepatitis C (HCV), and syphilis also exist in a waived testing environment. Erroneous reading can cause significant impacts to the patient. For this reason, it is important to establish good laboratory practices outside of the minimum CLIA requirements.

Widespread implementation of point of care testing presents an opportunity for medical laboratory professionals to demonstrate their capabilities outside of their traditional laboratory setting. Medical laboratory professionals are the only group of health care professionals trained in quality management systems, CLIA ‘88 regulations, and laboratory standards (e.g., Joint Commission, College of American Pathologists). Thus, they are essential to direct or oversee point of care testing programs as a qualified Technical Consultant. As the Technical Consultant, medical laboratory professionals must focus on maintaining the quality of testing and take a leading role in managing quality control and quality assurance programs in all sites where testing is performed.

In settings where a centralized laboratory is present, the Technical Consultant must maintain responsibility for developing appropriate training programs for all testing personnel (i.e., laboratory and non-laboratory) in the use of ancillary testing equipment, test procedures, documentation, review of test results, performance and monitoring of quality control, corrective action, proficiency testing, and equipment management. A review of personnel competency must be built into these programs. In collaboration with the appropriate clinical staff, the Technical Consultant must also take responsibility for defining appropriate parameters and establishing guidelines for repeat testing or result rejection.

When determining point of care testing applications, Institutions must be realistic in evaluating point of care testing costs, and mechanisms must be developed to prevent overutilization. Thorough cost accounting is needed to weigh the value of service versus cost by factoring the potential savings in potentially reduced lengths of stay. Those analyses that reveal additional expenses for this activity should be reviewed critically in light of rising health care costs. It may be advisable to establish a point of care testing task force to determine the type of testing needed, the format for the provision of such testing and the establishment of roles and responsibilities for the involved departments.

Therefore, it is the position of ASCLS that:

1. CLIA ‘88 regulations apply to all point of care testing programs regardless of testing location (e.g., clinics, pharmacies, hospital, laboratory, nursing facilities). Qualified, trained personnel should perform point of care laboratory testing.
2. Medical laboratory professionals should direct all point of care testing programs as a qualified Technical Consultant, ensuring that testing at the point of care meets all accreditation and regulatory requirements as mandated by regional, state, and/or federal entities. A qualified Technical Consultant should be available for consultation and training for non-hospital testing environments.
3. All testing personnel must meet regulatory qualifications and undergo training and competency assessment by a qualified Technical Consultant. When possible, personnel training should include standard operating procedures, quality control, quality assessment, instrument maintenance, and patient result review.
4. All point of care testing sites should develop and follow a quality assurance program and personnel competency program. Competency must be assessed annually by a qualified Technical Consultant.
5. Procedures should be clearly written by the Technical Consultant to ensure that proper protocols are followed by all testing personnel.
6. Maintenance procedures, as established by the Technical Consultant, will be followed and documented.
7. The Technical Consultant should retain the responsibility and authority for the selection and approval of instrumentation. Instrument selection should consider ease of operation, cost effectiveness, and quality resulting.
8. A needs assessment for the test menu should be developed through the joint effort of the laboratory and the appropriate clinical staff. The test menu should include only these tests that are clinically relevant for point of care and those tests should be performed only when action is taken immediately as a result of the data obtained.
9. Careful consideration must be given to evaluation of the relative benefit and cost of point of care testing. Care must be taken to review return on investment in addition to benefits to patient diagnosis and treatment.

References

1. College of American Pathologists, Laboratory General Checklist, rev. 09/22/2021
2. CLIA Statistical Tables. Accessed 02/19/2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Statistical_Tables_Graphs.
3. Electronic Code of Federal Regulations. Accessed 03/07/2022: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M.
4. How to Obtain a CLIA Certificate of Waiver. Accessed 05/01/2022: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincertificateofwaiver.pdf.
5. Centers for Disease Control and Prevention. CLIA Test Complexities. Accessed 05/01/2022: https://www.cdc.gov/clia/test-complexities.html
6. U.S. Food and Drug Administration. CLIA Categorizations. Accessed 05/01/2022: https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations#:~:text=A%20score%20of%201%20indicates,are%20categorized%20as%20high%20complexity.