ALL LABORATORY TESTING INCLUDING DECENTRALIZED TESTING IS REGULATED

In the U.S. all testing, including decentralized testing, is regulated according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) [1,2]. Congress passed CLIA'88 to ensure accurate, reliable and timely tests results regardless of test site. 

These requirements along with a series of announcements continue to evolve in response to changes in the testing environment and can be found in the codified edition of the Federal Register on the Centers for Disease Control and Prevention website [3]. 

Three federal agencies, the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) develop the specific requirements for testing sites to meet CLIA'88. 

All are based on test method complexity or difficulty to perform the testing, i.e., the more complicated the test, the more stringent the requirements. Three major test complexity categories for laboratory methodologies have been established - waived, moderate, and high complexity.

Most testing performed in decentralized sites is classified as waived or moderately complex. 

The specific classification for a methodology is available on the CMS website [4]. For the 50 plus "simple and fool-proof" waived tests, the only requirement under CLIA is to follow the test manufacturer's directions. pH, blood gases and electrolytes are classified as moderately complex. 

The minimum quality standards for moderately complex tests include mandates for personnel, quality control, quality assurance, proficiency testing (external quality assurance), and patient test management (requirements to maintain sample integrity and patient identification throughout the testing process) [2,3,5-9]. 

The test site must be aware that once any waived or moderately complex test methodology is modified, the test automatically becomes highly complex and is subject to CLIA's most stringent performance standards.

TO FOLLOW CLIA'88?

While all testing sites must meet the minimum CLIA requirements, not all sites directly follow CLIA. Several professional accrediting organizations having testing performance standards that meet or exceed those of CLIA have been "deemed" or approved by CMS.

When a testing site chooses to be accredited by one of these organizations and, through inspection, demonstrates compliance with the standards, the site, in essence, is meeting the CLIA requirements.

The primary deemed organizations include:  (1) The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), (2) the Laboratory Accreditation Program of the College of American Pathologists (LAP-CAP), and (3) COLA (formerly known as the Commission of Office Laboratory Accreditation) [10-12]. 

JCAHO accredits entire healthcare organizations and the decentralized test sites within the organization must meet, at a minimum, JCAHO requirements for testing. JCAHO does accept CAP and COLA inspections for sites performing moderate and high complexity tests. JCAHO, however, does not accept CMS (for CLIA) inspections. 

LAP-CAP inspects decentralized testing when it is under the direction of the central laboratory or when the site specifically seeks CAP accreditation. LAP-CAP does not accept JCAHO, CMS or COLA inspections. Testing sites seeking COLA accreditation are located primarily in physician offices and small hospitals. COLA will accept JCAHO inspections.

Usually decentralized testing sites have some latitude in choosing the regulations to follow. It is important to realize that the central laboratory and the decentralized sites within the same institution may be accredited by different organizations. 

To further complicate the picture, some states may impose additional requirements. The final determination is in large part the consequence of a series of institutional decisions based on who (the director) is responsible for decentralized testing. It is dependent on whether the decentralized testing site is under the central laboratory's CLIA certificate or has its own [9-14]. It also is influenced by the type of accreditation (i.e., JCAHO) sought by the institution as a whole.

All testing must be done under an appropriate CLIA'88 certificate.  Currently there are about 170.000 registered testing sites and 97.000 of these are associated with physician offices  (Table 1) [4]. 

Testing in most hospitals fits into one of two situations: (1) the central laboratory holds a single CLIA'88 certificate which covers all the hospital's testing, including decentralized testing, or (2) decentralized testing sites have one or more separate CLIA certificates. 

When decentralized sites are the central laboratory's responsibility, the director of the central laboratory is responsible for the overall quality of all testing and must …ensure that testing systems developed and used for each of the tests … provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing…[and]… ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur [2,3]. 

When a decentralized site has its own CLIA'88 certificate, the site is viewed and inspected as an independent laboratory. The site's director is responsible for meeting all the regulations and assuring its overall quality. 

Many hospitals having multiple testing sites establish a decentralized testing committee to help provide oversight and ensure that the right decisions are made for quality and effective testing that benefit the patient, staff and healthcare organization.

JCAHO wants to see "some evidence" that all test methods/instruments can meet the needs of the site's clientele.  This includes data on accuracy and precision, data that verifies the reportable range for each analyte, and confirmation (by the site's director) that the reference ranges are appropriate for the testing site's clientele.  However, this information only needs to be collected once for each method or instrument model. 

As part of the JCAHO total quality management philosophy, performance history, including QC data, can be used as the "evidence" of adequate performance when a method used in one location is instituted in another.

COLLEGE OF AMERICAN PATHOLOGISTS' LABORATORY ACCREDITATION PROGRAM (LAP-CAP)

CAP accredited sites must follow the LABORATORY GENERAL CHECKLIST (GEN) plus one of the three special Checklists that specifically address testing outside of the central laboratory:  (1) POINT-OF-CARE TESTING CHECKLIST (POC), (2) LIMITED SERVICES LABORATORY CHECKLIST (LSV) for a limited menu of tests, or (3) BLOOD GAS LABORATORY CHECKLIST (BGL), which is testing blood gases and related whole blood analytes at sites that are medically and/or administratively separate from the central laboratory. [11-18] 

CAP's philosophy is that all clinical laboratory tests must meet the same performance standards regardless of the CLIA test complexity classification.

QC

CAP also requires two levels of QC every 24 hours for most analytes, such as electrolytes, and two levels of controls every 8 hours of testing and each time a change in reagent occurs for automated hematology and coagulation. For pH and blood gases, CAP requires two levels of controls every 8 hours of testing (POC.0550, LSV.41650, BGL.27350). 

CAP also requires all decentralized test results to be recorded in a permanent record and be accompanied by appropriate reference ranges.

CAP allows electronic controls to fulfill the daily QC requirement for unmodified test systems cleared by the FDA and classified by CLIA as either waived or moderate complexity as long as these are a "scientifically acceptable alternative…that controls the entire analytic process" (POC, LSV and BGL "Controls" Section). 

The testing sites must have data to validate the reliability of these controls before placing them into routine use. CAP also mandates periodic evaluation of the stability of the test system with liquid controls. In all cases, the appropriate number and levels of controls must be included and the control results documented and reviewed to ensure the adequacy of the testing process.

VERIFICATION TEST METHOD PERFORMANCE SPECIFICATIONS

The Laboratory General Checklist (GEN) includes performance verification requirements - accuracy, precision, sensitivity, specificity, reportable range and reference range - for each test procedure. Specificity implies an evaluation of the method's ability to respond correctly in the presence of interfering substances.

CAP allows a testing site to rely on reagent/instrument manufacturers' data to establish specificity (GEN:42030) and permits the use of literature references or manufacturer's product information for the reference range as long as the ranges are appropriate for the testing site (GEN:40946). 

For all analytes, CAP requires testing sites to establish and reverify every 6 months the analytical measurement range, or reportable range, i.e., the range of values that the site accepts as being accurate (GEN:40944).  Technically, values outside the range should not be reported unless they can be verified, for example, on another instrument. 

TABLE IV: Comparison of Selected Testing Requirements by Organization

SUMMARY

CLIA'88 is synonymous with the implementation of uniform quality standards for all testing sites in the US. Decentralized testing sites in hospitals usually choose to meet the quality requirements of government  "deemed" professional organizations, primarily  -- JCAHO, CAP and COLA. Table 4 compares selected test requirements. 

The unique nature of decentralized testing (instruments, circumstances, personnel, etc.) must be considered when attempting to comply with testing regulations. The site's director must take an active roll in establishing and maintaining quality. 

Aside from complying with the basic quality mandates, an additional concern relates to education, since non-laboratory personnel often perform testing. Test sites must be engaged in a defined program for training testing personnel and assessing competency on an ongoing basis to ensure quality.