What's New With CLIA'88, JCAHO & CAP
Dr. Sharon Ehrmeyer, a frequent speaker on government regulations, graces our website with a timely essay on the newest developments in CLIA, JCAHO, & CAP. This article is an update of CLIA’88, the Joint Commission on Healthcare Organizations (JCAHO), and the College of American Pathologists (CAP) regulatory and accreditation guidelines. CLIA’88 establishes minimum performance standards for all clinical laboratories; JCAHO and CAP are professional organizations which have received deemed status from the Healthcare Financing Administration (HCFA). Both voluntary organizations inspect their members using standards that meet or exceed those of CLIA.
- CLIA'88 Waived Tests
- What's New from CDC?
- Alternate Quality Assessment Survey - AQAS
- Revisions to CLIA
- Mandates for the Final, Final Rule
- What's New from JCAHO?
- What's New from CAP?
- What's New with Checklist 30?
- Electronic Controls
- Top Deficiencies detected in Inspections
- The Future
Note: More recent essays have been written by Dr. Ehrmeyer about CLIA. Please check our CLIA Final Rules section for the latest.
The Clinical Laboratory Improvement Amendments (CLIA), which were originally signed into law in 1988, still have not been finalized.1 If and when this will happen is anyone’s guess! In the meantime, changes continue to be made.
This article is an update of CLIA’88, the Joint Commission on Healthcare Organizations (JCAHO), and the College of American Pathologists (CAP) regulatory and accreditation guidelines. CLIA’88 establishes minimum performance standards for all clinical laboratories; JCAHO and CAP are professional organizations which have received deemed status from the Healthcare Financing Administration (HCFA). Both voluntary organizations inspect their members using standards that meet or exceed those of CLIA.
CLIA’88 classifies all clinical laboratory testing into one of three categories -- waived, moderate, or high complexity. In the February 28, 1992 Federal Register that identified the requirements for laboratories to meet CLIA’88, eight simple tests were classified as waived. The waived category created immediate controversy. Many wanted it eliminated because of the subjective nature of the classification criteria and the possibility that some tests on the list were not truly error free. Others wanted to have the number of waived tests increased. This included physicians testing in office settings, who were unhappy with the burdensome regulations required for performing non-waived tests; patients wishing to do more home testing; and, manufacturers wanting their products in this category. Even HCFA and CDC expressed interest in expanding the waived category as a means by which to retain CLIA oversite of all laboratory testing, especially since some members of Congress attempted to repeal CLIA. To expedite the expansion of the category, the Department of Health and Human Services distributed a draft document for manufacturers to request waived status in 1993 and published a proposed guideline, Categorization of Waived Tests, in the September 13, 1995 Federal Register.[4,5]
As a result, manufacturers have had great success in placing their products on the waived list. As of April 28, 1997 new tests listed by the CDC include: H. pylori -- Serim Pyloritek Test Kit, Quidel QuickVue One-Step for whole blood and Delta West CLOtest; Strep A (throat only) Quidel QuickVue In-Line One-Step and Binax NOW; cholesterol -- Cholestech L.D.X., BMC Accu-Chek InstantPlus, ,ChemTrak AccuMeter, and J & J ADVANCED CARE; HDL Cholesterol -- Cholestech L.D.X.; Triglyceride -- Cholestech L.D.X.; gastric occult blood -- SmithKline Gastroccult; Microalbumin -- BMC Chemstrip Chemstrip Micral, and all qualitative color comparison pH testing for body fluid (other than blood) pH. To keep us up to date with all the new test additions and new methodologies for waived tests, the CDC has a Web site: [http://www.cdc.gov/phppo/dls/clia.htm now broken]
AQAS is a performance based, outcome-oriented, quality improvement self-inspection that allows some laboratories to forego on-site inspection. Eligible laboratories are those passing inspections with few or minor deficiencies and having satisfactory PT performance. Laboratories performing cytology testing and/or having complaints filed against them are excluded. Laboratories that change directors, add specialties, and/or increase test volume will be reviewed for consideration. For those participating in AQAS, on-site inspection will be conducted every four years. HCFA estimates that once everything is in place about 20% of approximately 38,000 laboratories surveyed for CLIA’88 compliance will be eligible for the quality assurance oriented survey.
For revisions to become official, they must be published in the Federal Register. Several revisions have been published since February, 1992.[7-9] Future updates will include the finalization of the proposed guidelines for manufacturers to submit product information for waived testing status consideration and a simplified process for states and professional organizations to seek exempt or deemed status from HCFA.
The deadline for phase-in of QC requirements for moderately complex tests was once again extended. Originally, September 1, 1994 was the deadline for manufacturers to petition the Food and Drug Administration (FDA) for approval of their specified QC/quality assurance protocols. If the FDA accepted the supporting data, the laboratory would meet CLIA QC requirements simply by following the manufacturer’s directions. The 1994 date was first to September 1996 and just recently was moved to July 31, 1998.
Until further notice from HCFA, laboratories performing moderately complex tests will meet the CLIA QC requirements by: following manufacturer’s instructions; having a procedural manual; calibrating or checking calibration at least every 6 months; running two levels of QC per day for most analytes; following specified QC procedures (e.g. blood gases, coagulation, etc.); performing/documenting remedial actions; and documenting QC activities and keeping the records for 2, 5, or 10 years, depending on the testing specialty.
At the May 29-30, 1996 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), the CDC outlined a more flexible approach for laboratories to meet the CLIA QC requirements. The challenge for CDC is one of accommodating new technology without rewriting the regulations. Current CLIA’88 QC requirements are based on using traditional (liquid) controls that evaluate the test system, the environment, and the analyst. The CDC’s new proposal combines the CLIA sections on patient test management, QC, and quality assurance into one entitled quality monitoring or quality assurance. This one would address the three areas:
- (1) prior to the testing process,
- (2) the testing process and
- (3) after the testing process.
If and when this is put into place, the CDC would permit the test system to be evaluated using acceptable alternative, non-traditional, QC approaches such as electronic controls and built-in function checks. The testing environment could be evaluated by laboratory monitors or manufacturer controls/safeguards; the analyst competence would be assured through documented training and performance assessment.
JCAHO, like all professional organizations receiving deemed status from HCFA, must have its standards for laboratory testing approved by HCFA. The current standards, Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services, were implemented in 1996 and will be used for inspection until they are updated in 1998.
More laboratories may be inspected by JCAHO, since JCAHO accredited institutions are purchasing physician office laboratories (POLs). These POLs, unless inspected by the Commission on Office Laboratory Accreditation (COLA), will need to comply with JCAHO requirements.
In 1998, JCAHO will move to more outcome based performance measurements and link the data to accreditation. Recently JCAHO announced the "ORYX" initiative that requires each of their accredited organizations to select clinical performance indicators and a performance measurement system. The collected performance data will become the basis for the JCAHO organization’s quality improvement activities. More information on this initiative can be found on JCAHO’s website - http://www.jcaho.org. JCAHO may also consider implementing a self-inspection system like CLIA’s AQAS, but it is first waiting for HCFA’s comments on the surveys.
While the current 1996 JCAHO standards are quality assurance oriented, they do, for the most part, closely follow the CLIA requirements. However, Anne Belanger, director of JCAHO Laboratory Accreditation Services, stated that there are some areas of confusion. The first is centered in the need to correlate test results from different instruments and different testing sites within the JCAHO institution. JCAHO considers the entire institution and does not want to see more than one level of care. Consequently, if patients have the potential of having testing done at multiple sites within an organization (e.g. the physician office, emergency room, and intensive care unit), test correlations between the sites must be made. This includes testing performed under different CLIA certificates. An exception is when patients, such as babies in the NICU, don’t move from site to site. In this situation, no test correlation is necessary provided the NICU is under its own CLIA number. CLIA’88 requirements only call for a correlation of test results performed under the same CLIA number.
JCAHO requires some validation of method data to provide evidence that methods used are meeting the needs of the organization’s clientele. This also includes tests in the waived category. Evidence should include data documenting the method’s accuracy and precision and that the reference ranges are suitable for the population being served. How the information is obtained and the amount of data collected are at the discretion of the laboratory director. The data do not need to be extensive and linearity assessment is not required. When the same method is offered at a new testing site, QC data and test performance history are adequate to confirm test validity.
Unlike HCFA, which does not inspect for waived tests, JCAHO does. JCAHO requires laboratories to analyze QC each day on automated instruments and at least at the frequency recommended by the manufacturer. All results must be documented. With QC failures, the documentation must include what was done to rectify the problem. The personnel authorized to do the testing must be identified along with their competence; and, an audit trail that ties the patients’ results with the instrument and QC values must be established. Waived tests are not subject to proficiency testing, although a testing site may choose to use PT as one means to assess personnel competency.
CAP’s standards are stated in a series of Checklists for the many areas of laboratory testing. These checklists are continually updated and new information appearing in one will be incorporated, when relevant, into the others when they are updated.
CAP considers all testing as highly complex in HCFA terms. For all quantitative and qualitative tests, including those identified as waived, CAP expects two levels of external QC included at least twice each run, documentation of authorized personnels’ competence, an audit trail tying the patients’ results with the instrument and QC. Proficiency testing is required for all analytes when available. A quality control review is required on the next routine shift when there is no on-site supervisor. In addition, a review is required at least weekly by the technical supervisor and monthly by the director or designee. With the QC review, there must be a mechanism for correlating unexpected test results with other clinical findings. This can include feedback from clinicians.
Checklist 30 (1997.0) for point of care testing (POCT) is one of the newest checklists. It was published in January, 1997 and replaces the one published in 1996.
Procedure manuals are acceptable in electronic form as long as the information is in essential compliance with the NCCLS procedure manual document (GP2-A3, a new version, replaces GP2-A2). One copy is sufficient for each accredited laboratory and manufacturers' inserts may be part of the manual. While testing personnel must attest to their familiarity with the contents of the manual (usually documented as part of the training process), card files or some other form of quick reference are acceptable for assistance when performing the procedure at POC. For CAP only, annual review of all procedures by the director/designee is mandatory.
For all methods, CAP requires laboratories to establish the reportable range, the range of values the laboratory defines as providing accurate results for the intended clinical use. Technically values outside the range should not be reported. Originally, CAP specified calibration verification -- a process requiring analysis of at least three points (minimum, mid-range, and maximum) -- as the means to confirm calibration stability and establish the reportable range. The new Checklist 30 states that reportable range can be defined several ways: linearity, calibration/recalibration, calibration verification, or correlation with other comparable methods. If calibration verification is used, it may extend reportable range beyond the range of calibrators and time to recalibrate. When the reportable range is limited to that established by calibration verification, recalibration is unnecessary. If calibration verification is not performed every six months, then recalibration is necessary. In addition, linearity need not be a separate process. Calibration verification can establish linearity and linearity can be used for calibration verification providing materials are used with known values.
CAP mandates laboratories to document that reagents are performing correctly and that they are not used beyond their expiration dates. CAP also requires laboratories to establish criteria for monitoring quality and stability for kits or individually packaged reagents based on volume of usage and storage requirements and to document that reagents are stored at the manufacturer’s recommended temperature.
The guide to complying with the CLIA regulations used by HCFA inspectors, the State Operations Manual (section §493.1202(c)(4) of Appendix C, February 28, 1992 Federal Register), identifies electronic controls as a suitable means for evaluating performance. However, from October 1995 through March 1996, the "hot topic" was whether electronic controls were an acceptable substitute for traditional, liquid controls. A series of confusing HCFA "interpretations" declared electronic controls not acceptable, then acceptable, then not acceptable, and finally, acceptable. In March of 1996, they declared that electronic controls were acceptable for now and that the issue would be addressed (resolved) by HCFA in CLIA’s final, final, final rule.
JCAHO also accepts electronic controls for now, but requires that the laboratory verify the manufacturer’s QC claims and run external (usually liquid) controls periodically to validate that no change occurred with the testing system. JCAHO is awaiting for CLIA’s final rule and the recommendations in NCCLS’ Quality Management for Unit Use Testing document which are still under development.
CAP requires laboratories doing quantitative tests to use QC materials with a matrix (presumably liquid controls) appropriate for the method. This also was the requirement for POCT. However, the new POCT Checklist states that certain unit-use devices/kits may warrant some combination of instrument, procedural, and/or electronic controls. Checklist 30 (question 30.0550) asks POC sites using alternative QC for scientifically acceptable evidence (documented information) that the entire analytical process is being evaluated correctly. For now, CAP only allows "acceptable" alternative QC for POCT.
Recently HCFA, JCAHO, and CAP released their most cited deficiencies identified in the inspection process. Knowledge of these can be helpful in preparing for inspection.
- QC procedures using at least 2 controls per test per day and documented QC activities
- Following manufacturer’s directions
- QA policies to evaluate quality of total testing process
- Lab director specifying responsibilities of all personnel and assuring proper education and training
- Analyst’s initials and name and address of lab on test report
- Enrollment in proficiency testing
- Procedure manual available that describes the testing and reporting of patient results
- Calibrating/checking calibration at least every 6 months
- Verification at least twice each year of accuracy of all analytes not included in PT
- Lab director assuring the competence of all personnel
- Daily surveillance of results
- Remedial actions
- Evaluation of analytical measurement equipment
- Review/remedial action for PT
- Preventive maintenance of equipment
- Microbiology media QC
- Adequate bench space
- Lab compliance with legal safety requirements
- Documented temperatures
- Test and control records for waived tests
- In absence of supervisor, review of test results on next shift
- Reference ranges on test report
- Incomplete labeling of reagents
- Linearity verification
- System to document errors
- Daily review of QC
- Absence of QC
- Enrollment in PT; PT not done by testing personnel; no corrective actions for PT failure
- Corrective actions for out of control situations
- Written QC program and QC records
One thing is certain -- change! Just when you think you know what is expected, the rules change! When will we see the final, final, final CLIA’88 regulations? I have quit asking, but when I used to ask, the answer was always "6 months from now or by the end of the year." It would appear that CLIA has been placed on the "back burner" while Congress deals with "more pressing issues," like balancing the federal budget and reducing Medicare spending. Both JCAHO and CAP will continue to refine and improve their laboratory performance standards. JCAHO’s revised standards will appear in 1998, and CAP just continues to update the checklists.
- Public Law 100-578, Section 353 Public Health Service Act (42 U.S.C. 263a) October 31, 1988.
- U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Federal Register 1992;57:7002-7186.
- Auxter S. POL exemption debate to begin on Capitol Hill, Clin. Lab. News 1995;21(8): 1,12.
- Schwartz M. Report on criteria for waiver, Clinical Laboratory Improvement Advisory Committee, U.S. Department of Health and Human Services, August 12, 1993, pp.5-8
- Schwartz M. Protocol for requesting waived status, Clinical Laboratory Improvement Advisory Committee, U.S. Department of Health and Human Services, August 12, 1993, p.3.
- Auxter S. Labs receive first round of paper CLIA inspection. Clin Lab News 1996; 22 (7):1,9
- U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA Programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Clinical Laboratory Act program fee collection. Fed Register 1993;58:5215-5237.
- U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA Programs: categorization of tests and personnel modifications. Fed Register 1995;60:20035-20051.
- U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA Programs: Extension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA. Fed Register 1997;62:25855-58.
- CDC Proposes New CLIA QC Approach. Government Affairs Update. Washington DC: American Association for Clinical Chemistry, June 1996, p.6.
- Accreditation Manual for Pathology and Clinical laboratory Services. Joint Commission on Accreditation of Healthcare Organizations. Oakbrook Terrace, IL, 1996.
- Auxter, S. JCAHO announces new accreditation process. Clin Lab News. 23:4 April 1997, 1 & 4.
- Laboratory accreditation program. College of American Pathologists. Northfield, IL, 1997.
- Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, Appendix C. US Department of Commerce, National Technical Information Service, Springfield, VA, 1992, p.C-122.
- Auxter S. HCFA bars electronic simulator controls for QC under CLIA’88. Clin Lab News 1996; 22 (7):1,3.
- Quality Management for Unit Use Testing; Proposed Guideline (EP18-P). Wayne PA: NCCLS (this document is under development and not available at this time).
Dr.Sharon Ehrmeyer, Ph.D., MT(ASCP) is Professor of Pathology and Laboratory Medicine and Director of the Medical Technology Program at the University of Wisconsin in Madison, Wisconsin. Dr. Ehrmeyer is active in the American Association for Clinical Chemistry, the American Society for Clinical Laboratory Science and the National Committee Clinical Laboratory Standards where she serves on the Board of Directors and chairs its pH/Blood Gas Committee. Dr. Ehrmeyer gives numerous presentations on laboratory regulations (CLIA, JCAHO, CAP and COLA), point of care testing and various quality issues. Her research interests focus on clinical laboratory quality and the impact of government regulations on laboratory practices.