QC - THE REGULATIONS

Sharon S. Ehrmeyer, Ph.D. 

If you perform laboratory tests in the US, the government's got you covered! One way or another, you have to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88), which establish the minimum standards for all laboratory testing, including specific regulations for quality control [1]. You can, however, select the organization that will administer these regulations or administer professional standards that are equivalent to these regulations:

There are other government approved organizations that have standards for laboratories to follow and some states impose specific requirements [2].

Health Care Financing Administration (HCFA) and Commission of Office Laboratory Accreditation (COLA) Requirements for QC

The first part of this discussion focuses on CLIA’88 and COLA regulations [1,3] since COLA's 200 question checklist adheres to the CLIA’88 QC requirements almost exactly. Professional standards administered via CAP and JCAHO are considered later.

CLIA QC Requirements based on Test Complexity

CLIA'88 regulations are based on four categories of test complexity: waived, provider performed microscopy (PPM), moderate complexity, and high complexity. Current information on test complexity can be obtained from the CDC’s web site (http://www.cdc.gov/phppo/dls/testcat.htm). Each testing category has different regulatory requirements for personnel, quality control, quality assurance, proficiency testing, etc.

Waived testing

This category requires the least regulation. Under CLIA and COLA, the minimum requirement for anyone performing waived testing is to follow the manufacturers’ directions for QC, and if no directions are included, to follow good laboratory practices. No specific QC requirements are identified. Good laboratory practice would dictate that controls be run and results documented and reviewed for correctness before reporting patient results. The tests that are waived include the following (current September 29, 1997 list of Waived Tests):

To keep up to date with all the new test additions and new methodologies for waived tests, you can check the CDC Web site [http://www.cdc.gov/phppo/dls/clia.htm].

Provider Performed Microscopy (PPM)

As of January 1993, the category "Physician-Performed Microscopy" was established under CLIA’88. In the April 24, 1995 Federal Register, the category was renamed to "Provider-Performed Microscopy." This category is a subset of moderate complexity and is exclusively for physicians, dentists, nurse practitioners and midwives, and physician assistants performing the testing as part of a patient examination. The primary instrument for performing the test(s) is the microscope.

The 9 tests identified under a PPM CLIA certificate can be performed, as well as waived tests. When these tests are provided, the practitioners are expected to follow the manufacturers’ directions for QC or follow good laboratory practices. Good laboratory practice would dictate that controls be run whenever possible and results documented and reviewed for acceptability before reporting patient results. The PPM category includes:

Moderate Complexity Tests

Approximately 75% of all tests performed in laboratories today fall in the category of moderate complexity. For this category, the QC requirements are identified in subpart K for CLIA’88 -- Quality Control. Originally, in the February 28, 1992 Federal Register, HCFA stated that as of September 1, 1994, laboratories would meet most of CLIA'88 QC requirements simply by following manufacturers' labeling, provided the FDA approved manufacturers' QC instructions. This never happened and the implementation date (9/1/94) has now been suspended, in the May 12, 1997 Federal Register, until at least 7/31/98.[5] Until HCFA implements new QC requirements, laboratories performing moderate complexity tests will meet the CLIA QC requirement by following sections §493.1201 and §493.1202(c) only.

Section §493.1201 (general QC: moderate or high complexity testing, or both) states: The laboratory must establish and follow written QC procedures for monitoring and evaluating the quality of the analytical testing process of each method to assure the accuracy and reliability of patient test results and reports.

Section §493.1202(c) identifies the specific requirements for unmodified moderate complexity tests: [1,4]

As you can see, CLIA QC includes a lot more than traditional statistical QC and defines standards for calibration, procedure manuals, remedial actions and record keeping. Concerning statistical QC, for most moderate complexity tests, the general requirement is to analyze two levels of QC materials on each day of testing. However, for certain tests, i.e., blood gases, hematology and coagulation tests, etc., CLIA requires additional QC:

In all cases, documentation of both the QC results and the specific remedial action to "out of control results" must be available to the inspector.

High Complexity Tests

This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as high complexity under CLIA. Laboratories under CLIA and COLA also must comply with Section §493.1201 (general QC): The laboratory must establish and follow written QC procedures for monitoring and evaluating the quality of the analytical testing process of each method to assure the accuracy and reliability of patient test results and reports. Section §493.1202 states for each test of high complexity performed, the laboratory must meet all applicable standards of this subpart (subpart K). For statistical QC, laboratories must be in compliance with the following sections:

What if a control fails to meet criteria for acceptability?

Regardless how a test has been classified, the regulations require "remedial action and documentation of this activity. Section 493.1219(b) Remedial actions states that when: "Results of controls and calibration materials fail to meet the laboratory's established criteria for acceptability, all patient test results obtained in the unacceptable test run or since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected and the laboratory must take remedial action necessary to ensure the reporting of accurate and reliable patient test results.

Joint Commision on Accreditation of Healthcare Organizations (JCAHO) Requirements for QC

The requirements identified for CLIA’88 and COLA also are applicable to JCAHO. Under JCAHO [6], the goal of QC is to achieve quality in laboratory testing and produce the best possible test results and outcomes. Additional JCAHO requirements are found for the different test classification categories.

JCAHO and Waived Testing

JCAHO recognizes waived tests as defined by CLIA'88, but identifies additional QC requirements that include:

JCAHO and Moderate Complexity Tests

For moderate complexity tests, JCAHO, for the most part, follows CLIA'88 and mandates the same seven QC requirements as CLIA’88 and COLA and also accepts electronic controls for now. However, for use of electronic controls, JCAHO 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 and High Complexity Testing

Testing sites must follow all the CLIA QC requirements for high complexity tests as well as for any modified moderate complexity tests (this includes not following the manufacturer’s directions) and tests developed in-house.

JCAHO Standards for Quality Control

In addition to the requirements identified above, JCAHO requires that all testing sites meet the following standards associated with quality control.

General QC Requirements:

Clinical Chemistry QC Requirements:

Hematology and Coagulation QC Requirements:

College of American Pathologists Laboratory Accreditation Program (CAP-LAP) Requirements for Quality Control

CAP-LAP's philosophy is that all clinical laboratory tests need to follow the requirements defined for high complexity testing under CLIA'88 [7]. Requirements for routine analysis of QC follow the CLIA requirements in terms of number and frequency, except controls must be included with all tests (even those identified as waived tests under CLIA'88). For now, CAP only allows "acceptable" alternative (electronic) QC for point of care testing. The latest POCT Checklist (Checklist 30, 1997.0) states that certain unit-use devices/kits may warrant some combination of instrument, procedural, and/or electronic controls. Question 30.0550 (Checklist 30) states that POCT sites using alternative QC must have scientifically acceptable evidence (documented information) that the entire analytical process is being evaluated correctly. Except for electronic controls, CAP requires that control specimens be tested in the same manner as patient samples.

Qualitative tests (even those with built-in controls) need to be evaluated with both a positive and negative control each day of use. For all tests, CAP-LAP requires an audit trail that ties the patients’ results with the analyst, instrument and QC. In addition, the QC program should show evidence of documented review on the next shift, if no supervisor is on site, and at least weekly review by the technical supervisor and monthly secondary review by the director or director's designee.

CAP Guidelines for Quality Control

In the general requirements, CAP states in Checklist #1 1997.1 that the overall QC program for the entire laboratory must be clearly defined and documented. It must include general policies and delegation of responsibilities. The QC records should be well-organized with a defined system to permit regular review by appropriate supervisory personnel.

Hematology QC Requirements (Checklist 2, 1996.2)

Automated/General Chemistry QC Requirements (Checklist 3, 1996.2)

References

  1. 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. Fed Regist 1992; 57:7002-186.
  2.  Laessig RH, Ehrmeyer SS: New Poor Man’s (Person’) Guide to Meeting the Regulations. R & S Consultants, Madison WI. 1997.
  3. Accreditation Manual. Commission on Office Accreditation (COLA). Columbia, MD, 1996.
  4. 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 Regist 1993:58:5215-37.
  5. 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 Regist 1997;62:25855-58.
  6. Accreditation Manual for Pathology and Clinical laboratory Services. Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Oakbrook Terrace, IL, 1996.
  7.  Laboratory Accreditation Program. College of American Pathologists (CAP). Northfield, IL, 1997.

Biography: Sharon S. Ehrmeyer, Ph.D.

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.

Copyright © 2000. All rights reserved
Westgard QC, 7614 Gray Fox Trail, Madison WI 53717
Call 608-833-4718 or e-mail westgard@westgard.com

A Message from JOW
QC Lessons | QC Applications | Questions | Multirule
CLIA Requirements | What's new? | Catalog | Demo Download
Home | Glossary | ARCHIVES | Links | Feedback