Point-Of-Care Testing And Physician Office Laboratories

Introduction: Definition Of Point-Of-Care Testing

Point-of-care testing (POCT) is laboratory testing that is performed outside the central or core laboratory and generally at the site of clinical care or close to the patient. In most settings, POCT is performed by clinical staff rather than laboratorians. Some POCT is also performed by the patient at home. This is the case for home glucose monitoring for diabetics and home coagulation testing for patients on warfarin.

Because POCT is mainly performed by nonlaboratorians, there are many challenges to ensuring that testing is performed in an appropriate and accurate manner. Regulatory requirements are available to help guide outpatient locations in the implementation and maintenance of important components of POCT, such as training, creating procedure manuals, performance of quality control, test validation, and documentation of results. Because testing is generally performed by people who are not trained in laboratory sciences and do not have a background in quality assurance and error reduction in laboratory testing, device manufacturers have built-in features to reduce the possibility of errors. These features include passwords for individual users with lock-out if training is not up-to-date, requirements for external and internal quality control prior to patient testing, and electronic transmission of results.

Some of the clinical settings in which POCT is performed include emergency departments (EDs) or urgent care settings, where quick decisions often need to be made; inpatient settings to maintain tight glucose control; physicians’ offices; health fairs; cancer centers that perform infusions; radiology sites prior to contrast administration; presurgical testing; nursing homes; and blood drives. This variety of settings involves a diverse group of health care workers who perform different types of tests. Depending on the type of testing, the clinical setting, and the test categorization (mandated by the Clinical Laboratory Improvement Amendments [CLIA]), testing may be performed by nurses, medical assistants, physicians, or office assistants. This diversity of clinical roles and levels of education means that training and testing responsibilities must be tailored to the individuals’ backgrounds as appropriate. For instance, a medical assistant may be trained to perform urine dipsticks in an outpatient setting, but a nurse may be responsible for reviewing daily quality control. Similarly, a physician or medical director on the CLIA certificate may be responsible for writing the procedure manual and oversight of training.

Oversight of POCT programs can be very complex and challenging owing to the mix of tests and devices, the number of people performing the tests, and the focus on clinical care over laboratory testing. Testing in a clinical laboratory is generally performed by a relatively small number of people trained in laboratory sciences whose primary focus is lab testing. Testing is also generally performed on only a few laboratory analyzers. This is in contrast to POCT, which is performed in a clinical site by health care providers who have other responsibilities besides POCT. They are generally trained in patient care, not clinical laboratory sciences. Also, POCT is frequently distributed over a larger number of devices, with each performing a relatively low volume of testing, requiring more validation, calibration, quality control, and so on.

Regulatory Requirements

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) set basic standards for laboratories to follow to ensure the accuracy of patient test results regardless of the setting in which they are performed (Code of Federal Regulations, Part 493). These standards apply to central or core laboratories performing testing on samples received from inpatient and outpatient locations; they also apply to any other site performing testing, including POCT and provider-performed microscopy procedures (PPMPs). CLIA defines four different categories of tests based on the following factors: level of training and education required to perform the test, reliability and stability of the reagents, complexity of operational steps, availability and stability of quality control and proficiency of testing materials, requirements for maintenance of the test system, and the level of judgment and interpretation required to perform the test and compile the results. The levels of complexity are waived testing, provider-performed microscopy, moderate-complexity, and high-complexity testing. The United States Food and Drug Association (FDA) determines the level of complexity based on the preceding criteria ( http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393229.htm ). Waived testing requires minimal training and education to perform and/or would theoretically cause minimal harm if the results were not accurate ( Box 7.1 ). Many point-of-care tests are waived, including any tests approved for home use. Testing such as urine dipsticks, qualitative human chorionic gonadotropin (hCG), and glucose are generally waived. Some point-of-care international normalized ratio (INR) devices are waived, and the U.S. Food and Drug Administration (FDA) has recently granted CLIA waivers to a few nucleic acid–based influenza diagnostic tests. PPMPs are a discrete set of tests in which specimens that are time-dependent are examined under a microscope at the point of care ( Table 7.1 ). PPMP can be performed only by licensed professionals such as physicians and dentists, as well as nurse practitioners and physician assistants under the direction of a physician, depending on the state in which they practice. Moderate- and high-complexity testing is usually performed in larger and more advanced laboratory settings, including hospital and reference laboratories.

A CLIA certificate must be issued for a site to perform laboratory testing. Five different types of certificates are issued: Certificate of Waiver, Certificate for Provider-Performed Microscopy Procedures, Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation ( Box 7.2 ). Some examples of accreditation organizations are The Joint Commission and the College of American Pathologists (CAP). When a hospital laboratory is issued a certificate, all testing that is performed in that building or any contiguous buildings falls under the laboratory’s certificate. Any testing that is performed at a separate location, even if it is overseen by the hospital laboratory and has the same laboratory director, must have its own certificate.

CLIA 88 established the laboratory requirements for testing personnel, supervisory personnel, laboratory directors, testing facilities, test validation, procedure manuals, personnel training and competency, quality control, proficiency testing, and reporting results. Some states, including New York, California, and Florida, have more stringent laboratory regulations than those mandated by CLIA. Also, laboratories that choose to be accredited by CAP face some stricter requirements.

Laboratory Directorship

Laboratories that operate under a Certificate of Waiver or with a certificate for PPMP can perform waived testing without the overhead of having personnel who meet established qualifications in training, experience, job performance, and competency. However, if any moderate-complexity tests or measurements are performed, CLIA requires that the laboratory be directed by a laboratory director and/or a laboratory consultant with appropriate credentials. This director is responsible for determining the qualifications of individuals performing and reporting test results, as well as ensuring compliance with all applicable regulations. The director is also responsible for the analytic performance of all assays and must monitor ongoing proficiency testing, accuracy, and precision. If more than one individual in the practice qualifies as a laboratory director, the laboratory is required to designate one as being responsible. It must be demonstrated that the laboratory director is providing effective direction for the operation of the laboratory. If one does not provide onsite direction, one must provide phone consultation or delegate to qualified personnel with specific responsibility as required by regulation.

For POCT, a separate certification is usually not necessary when it is performed under the supervision of the laboratory director responsible for laboratory services in a health care facility. POCT that occurs within a health care facility at sites that are located in contiguous buildings on the same campus and under common direction can be performed under the certificate of the parent organization. When assays and procedures are performed in a situation such as this, the terms waived and complexity no longer apply. The test menu is no longer restricted to waived testing—more frequent inspections and higher scrutiny are received in return. Because the parent organization typically has a certificate that allows testing at all levels of complexity, it is the responsibility of the laboratory director to ensure that the test method used at the POCT site is appropriate for the skills and training of those performing the test. What inspectors do not tolerate could be called “rogue testing.” This occurs when a clinic or service sets up a test without the knowledge and supervision of the laboratory director. With the tracer method used by accrediting agencies such as The Joint Commission, if an inspector finds a lab result and traces it back to a laboratory that is not adequately supervised by the laboratory director, a citation may be issued to the health care facility.

Compliance

In addition to CLIA, all laboratories must adhere to regulatory procedures, particularly in the outpatient setting. First, all testing for which Medicare is billed must be medically necessary. Screening tests and other measures of wellness generally are not covered. Medical necessity determination is implemented by Medicare, Medicaid, and other insurance carriers through Current Procedural Terminology (CPT) codes used in conjunction with International Classification of Disease (ICD) codes. When the ICD-10 code does not warrant the CPT-4 code, payment is rejected. Even worse, if it is determined that a laboratory deliberately added codes to obtain a higher payment than it deserves or payment for work that it has not done, it can be charged with fraud, which is a felony, and the laboratory will be subjected to fines. Errors are assumed to be deliberate unless a compliance program is in place that actively seeks to uncover billing errors.

Another potential pitfall is Stark regulations. The Stark laws, which are named after their original sponsor, Representative Fortney Pete Stark (D-Calif.), were intended to prevent unnecessary self-referrals intended to boost revenue. Under Stark, physicians are prohibited from referring Medicare patients to laboratories in which the physician (or a close family member) has a financial interest. Because this prohibition would be detrimental to most physician office laboratories (POLs), it is important to understand the “safe harbors” that allow legitimate self-referral.

CLIA 88 created standards for POLs and POCT in the United States that predated similar measures on the international scene. However, an international working group has proposed and adopted ISO 22870-2006 as an international standard for POCT. These standards are more extensive than current CLIA requirements; however, CLIA is a minimum federal requirement, and states and other accrediting agencies can impose standards that are more rigorous. has published a summary of these international standards with cross-referencing to current CAP accreditation standards.

Types Of Point-Of-Care Testing

Many different analytes can be used for point-of-care tests. Some of these tests are single-use cartridges, such as rapid HIV tests and urine pregnancy tests, and manual tests that require testing personnel to record a result, such as a urine dipstick or fecal occult blood testing. Other tests are performed on portable multiuse devices that may require a blood draw or fingerstick. These include many glucometers, coagulation monitoring devices, blood gas analyzers, and point-of-care chemistry analyzers ( Table 7.2 ).