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Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary

U.S. Department of Health and Human Services Public Health Service Centers for Disease Control Public Health Practice Program Office Atlanta, Georgia 30333

The MMWR series of publications is published by the Epidemiology Program Office, Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, Atlanta, Georgia 30333.

SUGGESTED CITATION Centers for Disease Control. Regulations for implementing the Clinical Laboratory Improvement Amendments of 1988: a summary. MMWR 1992;(No. RR-2) (inclusive page numbers).

Centers for Disease Control William L. Roper, M.D., M.P.H. Director

The material in this report was prepared for publication by:

Public Health Practice Program Office Edward L. Baker, M.D., M.P.H. Director

Division of Laboratory Systems Carlyn L. Collins, M.D., M.P.H. Director

Betty V. Addison Assistant Director for Regulatory Affairs

Laboratory Practice Assessment Branch Thomas L. Hearn, M.S. Chief

Devery A. Howerton, Ph.D. Health Scientist

Office of the Director, CDC James D. Bloom Senior Advisor for Public Health Management

The production of this report as an MMWR serial publication was coordinated in:

Epidemiology Program Office Stephen B. Thacker, M.D., M.Sc. Director

Richard A. Goodman, M.D., M.P.H. Editor, MMWR Series

Scientific Communications Program Public Health Publications Branch Suzanne M. Hewitt Chief

Ava W. Navin, M.A. Project Editor

Morie E. Miller Editorial Assistant

Contents Introduction Categories of Tests by Complexity

Tests Designated for Certificate of Waiver Tests of Moderate Complexity Tests of High Complexity Certification Proficiency Testing Patient Test Management Quality Control Personnel

Personnel For Laboratories Conducting Moderate-Complexity Testing

Personnel For Laboratories Conducting High-Complexity Testing Quality Assurance Cytology Requirements

Proficiency Testing Quality Control Personnel Inspections Consultation Additional Information

Regulations for Implementing the Clinical Laboratory Improvement

Amendments of 1988: A Summary

In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), which set standards to improve the quality of clinical laboratory testing in all laboratories in the nation that conduct testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease. This report summarizes the final regulations for implementing CLIA and provides an overview of each section, specifying laboratory standards and requirements. INTRODUCTION

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (PL 100-578) resulted from public and congressional concerns about the quality of clinical laboratory testing in the United States and set standards designed to improve quality. They revise and supersede the Clinical Laboratory Improvement Act of 1967 and expand federal oversight to include virtually all laboratories in the country that conduct testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease. The clinical laboratory is an important component of the health-care system that touches on all aspects of CDC\'s mission, including programs dedicated to patient management, health screening, health promotion, and disease prevention. The importance of accurate and reliable laboratory results in health care is unquestioned. The regulations summarized here for readers of the MMWR series will affect laboratory practice with the goal of improving and maintaining quality. Many laboratories will be federally regulated for the first time and may need supplemental information to support their efforts in complying with the new requirements. This publication is intended for a large audience--both providers and users of laboratory services.

The regulations for implementing CLIA, developed by the Department of Health and Human Services (DHHS), consist of four separate sets of rules: a) laboratory standards, b) application and user fees, c) enforcement procedures, and d) approval of accreditation programs. (See ``Additional Information'' on page 16 for references.) The set of rules describing the laboratory standards (42 CFR Part 493, HSQ-176) comprises most of the regulations with which laboratories must comply; it will be the focus of this summary. Each subpart of the regulations is briefly described, and subparts are arranged in the order in which they appear in the regulations. The regulations are extensive and complex, and this summary is intended to give the reader an overview and a general understanding of their content. It does not provide specific details of the requirements for all laboratory situations.

In developing the regulations, DHHS considered thousands of comments to the proposed regulations (published on May 21, 1990) and consulted with many clinicians, laboratorians, and others with expertise in clinical laboratory testing. The final regulations, published on February 28, 1992, set minimum standards for laboratory practice and quality and specify requirements for proficiency testing, quality control, patient test management, personnel, quality assurance, certification, and inspections. Some requirements in proficiency testing, quality control, and personnel are being phased in over varying periods of time; the remaining requirements become effective on September 1, 1992. They will supersede the current regulations for CLIA `67, Medicare, and Medicaid programs, which were published in March 1990.

The regulations stratify the requirements that apply in various laboratory situations according to the technical complexity in the testing process and risk of harm in reporting erroneous results, a fundamental change from the previous regulations, which were based on location or type of operation. The same regulations apply to all testing sites, including laboratories in physicians' offices. The three types of testing excluded from regulation by CLIA are a) testing for forensic purposes, b) research testing for which patient-specific results are not reported, and c) drug testing performed by laboratories certified by the National Institute on Drug Abuse (NIDA) that meets NIDA guidelines and regulations.

CATEGORIES OF TESTS BY COMPLEXITY

The regulations establish three categories of testing on the basis of the complexity of the testing methodology: a) waived tests, b) tests of moderate complexity, and c) tests of high complexity. Laboratories may perform tests in only one category of testing or in any combination of the three. Laboratories performing moderate- or high-complexity testing or both must meet requirements for proficiency testing, patient test management, quality control, quality assurance, and personnel. These specific requirements do not apply to tests in the waived category. The regulatory requirements between moderate- and high-complexity testing differ mainly in the standards for quality control and personnel.

On the basis of specific criteria, tests are categorized as either waived, moderate complexity, or high complexity. The statute specifies criteria for waived tests as those examinations and procedures that a) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, b) pose no reasonable risk of harm to the patient if the test is performed incorrectly, and c) have been cleared by the Food and Drug Administration (FDA) for home use. Eight tests have been determined to meet these criteria (Table 1). All other test methodologies (which include approximately 10,000 specific tests or procedures) are categorized as being of either moderate or high complexity according to seven criteria: a) degree of knowledge needed to perform the test; b) training and experience required; c) complexity of reagent and materials preparation; d) characteristics of operational steps; e) characteristics and availability of calibration, quality control, and proficiency testing materials; f) troubleshooting and maintenance required; and g) degree of interpretation and judgment required in the testing process.

The regulations list the waived tests, and the preamble to the regulations provides a listing of the general types of tests and procedures included in the moderate- and high-complexity categories. A preliminary specific listing of tests by analyte and, when appropriate, by manufacturer was published separately in the Federal Register on the same date that the regulations were published. A complete list of tests will be published before the effective date of the regulations, and updates will be published periodically. These lists will appear as notices in the Federal Register. The regulations also define a process for future categorization and recategorization of tests.

Tests Designated for Certificate of Waiver

Eight tests meet the criteria for waiver (Table 1). Laboratories performing only the tests on this list are eligible for a certificate of waiver; they must follow manufacturer's instructions for test performance and permit inspections as part of random compliance evaluations or complaint investigations. Otherwise, laboratories with a certificate of waiver will not be subject to routine inspections. The regulations do not specify quality control, quality assurance, personnel, or proficiency testing requirements for performing waived tests. Tests of Moderate Complexity

More than 40 general types of tests or procedures have been categorized as moderate complexity (Table 2). A preliminary list of specific test systems, assays, and examinations within these general categories, arranged by analyte, was published concurrently with the regulations in the Federal Register. A complete list will be published by the effective date of the regulations. Laboratories performing one or more of these tests of moderate complexity must meet certain requirements. Tests of High Complexity

Certain laboratory subspecialties and more than 50 general tests or procedures have been categorized as high complexity (Table 3). As with tests of moderate complexity, a list of specific test systems, assays, and examinations was published in the Federal Register (as will any future updates). Laboratories performing one or more of these tests of high complexity must meet certain requirements.

TABLE 2. Tests of moderate complexity, as specified in the preamble to the regulations for implementing the Clinical Laboratory Improvement Amendments of 1988 Bacteriology

  • Primary culture inoculation

  • Urine culture and colony count kits

  • Microscopic evaluation of direct wet-mount preparations

  • Isolation and identification (presumptive and/or confirmatory) of aerobic bacteria from throat, urine, cervical, or urethral specimens

  • Gram stain

  • Darkfield examinations for Treponema pallidum

  • Manual procedures with limited steps and with limited sample or reagent preparation

  • Manual screening devices for bacteriuria with limited steps and with limited sample or reagent preparation

  • Automated procedures that do not require operator intervention during the analytic process Mycobacteriology

  • Direct acid-fast smear Mycology

  • Primary culture inoculation

  • Isolation of yeast with identification limited to Candida albicans (excluding semi-automated and semi-quantitative procedures)

  • Microscopic evaluation of direct wet-mount preparations

  • Microscopic evaluation of KOH preparations

  • Tests using selective media for the presence or absence of dermatophytes

  • Manual procedures with limited steps and with limited sample or reagent preparation

  • Automated mycology procedures that do not require operator intervention during the analytic process Parasitology

  • Microscopic evaluation of pinworm preparations

  • Microscopic evaluation of direct wet mounts for presence or absence of parasites

  • Manual procedures with limited steps and with limited sample or reagent preparation

  • Culture devices indicating the presence or absence of Trichomonas vaginalis Virology

  • Manual procedures with limited steps and with limited sample or reagent preparation

  • Automated procedures that do not require operator intervention during the analytic process Immunology

  • Manual procedures with limited steps and with limited sample or reagent preparation

  • Automated procedures that do not require operator intervention during the analytic process

  • Darkfield examinations for Treponema pallidum Chemistry

  • Manual procedures with limited steps and with limited sample or reagent preparation

  • Automated procedures that do not require operator intervention during the analytic process

  • Automated blood gas analyses that do not require operator intervention during the analytic process

  • Whole blood measurements using stripmeters (excluding glucose monitoring devices cleared by the Food and Drug Administration specifically for home use)

  • Osmolality measurements Urinalysis

  • Microscopic analysis of urinary sediment

  • Automated urinalysis procedures that do not require operator intervention during the analytic process Hematology

  • Automated hematology procedures without differentials that do not require operator intervention during the analytic process

  • Automated hematology procedures with differentials requiring no operator intervention during the analytic process and no interpretation of a histogram or scattergram

  • Automated coagulation procedures that do not require operator intervention during the analytic process

  • Manual white blood cell differentials without identification of atypical cells

  • Manual hematology or coagulation procedures with limited steps and with limited sample or reagent preparation Immunohematology

  • Manual or semi-automated procedures with limited steps and with limited sample or reagent preparation

  • Automated procedures that do not require operator intervention during the analytic process Other

  • Semen analysis for the presence or absence of sperm

  • Occult blood in body fluids

  • Crystal analysis of joint fluid

  • Viscosity

TABLE 3. Tests of high complexity, as specified in the preamble to the regulations for implementing the Clinical Laboratory Improvement Amendments of 1988 Clinical cytogenetics -- all procedures Histocompatibility -- all procedures Histopathology -- all procedures Cytology -- all procedures Bacteriology

  • Isolation and identification of aerobic and anaerobic bacteria from specimens not specified as being of moderate complexity

  • Automated or semi-automated procedures requiring operator intervention during the analytic process

  • Serogrouping and typing

  • Antigen or toxin test procedures or kits requiring microscopic evaluation

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Semi-automated nonculture urine screening devices for predicting bacteriuria Mycobacteriology

  • Concentration, smear, and primary culture inoculation

  • Isolation and identification techniques

  • Antimycobacterial susceptibility testing

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Automated or semi-automated procedures requiring operator intervention during the analytic process Mycology

  • Isolation and identification of all fungi not specified as being of moderate complexity

  • Identification techniques requiring interpretative skill

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Automated or semi-automated mycology procedures requiring operator intervention during the analytic process Parasitology

  • Concentration or differential staining techniques

  • Identification techniques requiring interpretative skills

  • Antigen test procedures or kits requiring microscopic evaluation

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process Virology

  • Isolation and identification techniques

  • Antigen test procedures or kits requiring microscopic evaluation

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Automated or semi-automated procedures requiring operator intervention during the analytic process Immunology

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Automated or semi-automated procedures requiring operator intervention during the analytic process

  • Immunoassay methods requiring microscopic evaluation

  • Radioimmunoassays

  • Gel-based immunochemical procedures

  • Electrophoresis

  • Western blot

  • Cell phenotyping and analysis

  • Procedures requiring cell- or tissue-culture techniques Chemistry

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Automated or semi-automated procedures requiring operator intervention during the analytic process

  • Blood gas analyses requiring operator intervention

  • Atomic absorption

  • Flame photometry

  • Electrophoresis

  • Gel-based immunochemical procedures

  • Radioimmunoassays

  • Anodic stripping voltammetry

  • Mass spectrometry Urinalysis

  • Automated or semi-automated procedures requiring operator intervention during the analytic process Hematology

  • Automated or semi-automated procedures requiring operator intervention during the analytic process

  • Manual hematology or coagulation procedures with multiple steps in sample or reagent preparation or the analytic process

  • Manual white blood cell differentials with identification of atypical cells

  • Manual reticulocyte counts

  • Manual cell counts

  • Manual platelet counts

  • Bone marrow evaluation

  • Flow cytometry

  • Hemoglobin electrophoresis Immunohematology

  • Manual procedures with multiple steps in sample or reagent preparation or the analytic process

  • Automated or semi-automated procedures requiring operator intervention during the analytic process

  • Compatibility testing (includes any of the following when performed in the process of determining donor/recipient compatibility: recipient and donor ABO group/D(Rho) type/special antigen typing; direct antiglobulin test; unexpected antibody detection and identification; crossmatch procedures) Other

  • Semen analysis (quantitative)

  • Eye bank microscopy procedures

CERTIFICATION

All laboratories that are subject to CLIA must obtain appropriate certification documents. Initially, laboratories must obtain either a certificate of waiver or, if performing nonwaived testing, a registration certificate from the Health Care Financing Administration (HCFA). A certificate of waiver is valid for a maximum of 2 years. A registration certificate is valid for 2 years or until such time as an inspection to determine compliance can be conducted, whichever is shorter. A laboratory meeting applicable requirements will then be issued either a certificate (for laboratories complying with the DHHS program) or a certificate of accreditation (for laboratories complying with DHHS-approved private, nonprofit accreditation programs). Alternatively, a laboratory may acquire a state license in lieu of either certificate if it is in a state with a federally approved licensure program. Laboratories that obtain state licenses will be required to comply with state rules and will be exempt from the CLIA program.

PROFICIENCY TESTING

Proficiency testing (PT) is mandated by CLIA as a method to externally evaluate the quality of a laboratory's performance. For PT, a laboratory is provided with specimens having known composition to analyze in the same manner as patient specimens. Each laboratory performing tests of moderate or high complexity is required to enroll in an approved PT program for all specialties and subspecialties for which it seeks certification. Because thousands of laboratories that have not been previously regulated will be subject to these new rules, the PT requirements are being phased in gradually to allow laboratories and PT program providers adequate time to meet them. The newly regulated laboratories must enroll and participate in PT by 1994. To allow these laboratories time to learn the PT process without penalties for errors, they will not be subject to penalties for unsuccessful PT performance until 1995. (However, if failure is so severe as to suggest that patient health and safety are jeopardized, immediate action will be taken.)

Currently regulated laboratories are required to continue to participate in PT, with the exception of cytology, for which participation is required by 1994. Because PT for cytology is substantially different from that for the other subspecialties, it is discussed separately.

Each laboratory must participate successfully in PT for each specialty, subspecialty (Table 4), analyte, or test for which it is certified and for which PT is required. For any tests performed by a laboratory that are not included in the list required for PT participation, the laboratory must still establish the accuracy and reliability of its testing procedure. Each PT shipment includes five samples for each analyte or test; the laboratory must participate in three such testing events per year. A separate grading formula is established for each specialty/subspecialty. Specialties or subspecialties are given an overall score, and some are also scored for each analyte or test. For most specialties/subspecialties, analytes, or tests, the minimum passing score is 80%. (The exceptions are ABO and D(Rho) typing and compatibility testing, for which 100% is required.)

If a laboratory fails a PT event for any specialty, subspecialty, analyte, or test, then it must undertake the necessary remedial action to correct the problem. A laboratory that fails two consecutive or two of three testing events will be subject to sanctions for that specialty, subspecialty, analyte, or test. A laboratory may also voluntarily withdraw its certification for a specialty, subspecialty, analyte, or test. If sanctions result in the suspension of a laboratory's certificate or cancellation of its Medicare approval, or if the laboratory voluntarily withdraws its certification because of PT failures, its certification will be reinstated after a 6-month period if it demonstrates satisfactory performance on two consecutive PT events, one of which may be on site.

CLIA regulations also establish detailed rules for PT program providers, which specify requirements for sample preparation, distribution, result reporting, records, and problem solving. The basic program for each specialty or subspecialty includes details for the program content, frequency of testing, and the evaluation of a laboratory's performance, based on the types of services offered within a specialty or subspecialty.

PATIENT TEST MANAGEMENT

Each laboratory performing tests of moderate or high complexity is required to establish and maintain a system that assures optimum integrity and identification of patient specimens throughout the testing process and accurate reporting of results. The regulations specify requirements for specimen submission and handling, test requisitions, test records and reports, and specimen referral.

QUALITY CONTROL

Each laboratory must establish and follow written quality control procedures that monitor and evaluate the quality of the analytic testing process of each test method to assure accurate and reliable patient test results. The regulations contain two sections on quality control (QC): a) general QC requirements and b) additional special requirements for specialties or subspecialties. QC for cytology is addressed in a separate discussion below. Some of the general QC requirements are being implemented in stages, so that different requirements apply for the first 2 years after the regulations become effective (Table 5).

For the first 2 years after the regulations are effective, those instruments, kits, or test systems categorized as moderate complexity that are cleared by the FDA for in vitro diagnostic use have minimal QC requirements. Tests of high complexity or tests of moderate complexity developed in-house or cleared for in vitro diagnostic use that are modified by the laboratory must be performed following the full QC requirements.

The FDA will evaluate whether products meet CLIA requirements for QC, so that, after 2 years from the effective date of the regulations, laboratories using tests of moderate or high complexity that have been cleared in this manner can follow the manufacturer's instructions for much of the general QC. Laboratories using tests not cleared in this manner must follow all applicable QC rules.

The elements contained in the general QC section include requirements for maintaining acceptable test methods, equipment, reagents and materials, guidelines for procedure manuals, establishment and verification of test performance characteristics, calibration and control procedures, corrective actions to be taken when problems arise, and QC records.

Additional QC requirements are listed for each specialty or subspecialty, including the subspecialties under microbiology, diagnostic immunology, and chemistry (Table 4), as well as hematology, cytology, histopathology, oral pathology, radiobioassay, histocompatibility, clinical cytogenetics, immunohematology, and transfusion services and blood banking.

PERSONNEL

CLIA rules link personnel requirements with the complexity of testing. The requirements differ substantially for personnel who perform moderate- and high-complexity testing and thus are defined separately. The regulations list specific qualifications for the various positions and also define the functions and responsibilities for the persons who fill these positions. Persons who are qualified may perform the functions of more than one position in either moderate- or high-complexity testing. For example, the same person may function as both the laboratory director and the clinical consultant. In some cases, one person could qualify and function in all of the positions listed.

Personnel For Laboratories Conducting Moderate-Complexity Testing

Qualifications and responsibilities for personnel who perform moderate-complexity testing are specified for the following: a) laboratory directors, b) technical consultants, c) clinical consultants, and d) testing personnel. The laboratory director qualifications list requirements for both formal education and laboratory training or experience. The director must hold a degree in medicine, osteopathy, or one of the sciences at the doctoral, master's, or bachelor's level. The requirements for training or experience vary from 1 year at the doctoral level to 2 years at the master's level and 4 years at the bachelor's level. Additionally, on the publication date of the regulations, a person who is qualified or could have qualified as a director under the previous federal regulations, or who qualifies as a director under state law, will continue to qualify as a director. The director is responsible for the overall operation and administration of the laboratory as well as several specific responsibilities described in the regulations. One person may direct a maximum of five laboratories.

The technical consultant must be a doctor of medicine or osteopathy or have a doctoral, master's, or bachelor's degree in one of the sciences with laboratory training or experience in each of the specialties or subspecialties for which he or she is providing consultation. The laboratory director may function as the technical consultant in those specialties or subspecialties in which he or she has the requisite training or experience. The technical consultant is responsible for the technical and scientific oversight of the laboratory.

The clinical consultant serves as the liaison between the laboratory and its clients in matters related to reporting and interpreting results. The clinical consultant must be a doctor of medicine or osteopathy or a doctoral-level scientist who is board certified.

The testing personnel (the persons responsible for specimen processing, test performance, and reporting of results) must have, at minimum, a high-school diploma and the appropriate training as specified in the regulations, or have an associate's degree or above in one of the sciences.

Personnel For Laboratories Conducting High-Complexity Testing

The regulations specify more stringent personnel requirements for laboratories where high-complexity testing is performed. These laboratories must employ persons who perform the functions specified for the following: a) laboratory directors, b) technical supervisors, c) clinical consultants, d) general supervisors, and e) testing personnel. In addition, specific requirements apply to personnel in laboratories where cytology services are performed (discussed in the cytology section that follows).

To qualify as a laboratory director, a person must have a doctoral degree in medicine, osteopathy, or one of the sciences and either be board certified or have specific training or experience. For a 2-year period, persons with a doctoral degree in one of the sciences and 4 years of laboratory training or experience (2 years of which involved directing or supervising high- complexity testing) can qualify as directors. By the end of the 2-year period, these persons must have become board certified in an area of clinical laboratory science to continue as director. In addition, a person who on the publication date of the regulations is serving as a laboratory director and is qualified or could have qualified as a director under the previous federal regulations will continue to qualify as a director. Also, a person who qualified as a director under state law on the publication date of the regulations will continue to qualify. The director's responsibilities for the overall operation and administration of the laboratory where high-complexity testing is performed are essentially the same as those for moderate-complexity testing, including the limit of directorship to five laboratories for one person.

The qualification requirements for the technical supervisor, the person responsible for the technical and scientific supervision of the laboratory where high-complexity testing is performed, vary with the specialty or subspecialty. In general, qualifications range from a minimum of a bachelor's degree in one of the sciences plus 4 years of training or experience, to board certification in pathology with no additional training or experience. Subspecialties that require doctoral-level technical supervisors are cytology, histopathology, dermatopathology, ophthalmic pathology, oral pathology, histocompatibility, clinical cytogenetics, and immunohematology. The responsibilities of the technical supervisor are similar to those specified for the technical consultant in laboratories certified to perform tests of moderate complexity.

The qualifications and responsibilities for the clinical consultant in laboratories certified to perform tests of high complexity are essentially the same as those for laboratories conducting moderate-complexity testing. Unlike laboratories certified for moderate-complexity testing, those where high-complexity testing is performed must have a general supervisor(s) who provides day-to-day supervision of the testing personnel and reporting of results. Except for subspecialties in histopathology, which require board-certified pathologists, the person functioning as the general supervisor must have a doctoral, master's, or bachelor's degree in medicine, osteopathy, or one of the sciences and 1 year of appropriate laboratory training or experience or an associate's degree and 2 years of training or experience. Additionally, persons who on the publication date of the regulations are qualified or could have qualified as general supervisors under the previous federal regulations will continue to qualify. The general supervisor must be accessible to testing personnel at all times and must provide on-site direct supervision to testing personnel who are high-school graduates and cannot meet the other qualification requirements.

Except for histopathology, in which only board-certified pathologists or pathology residents are authorized to perform testing (tissue examination), persons who perform high-complexity testing without direct supervision must have at minimum an associate's degree in a laboratory science or medical laboratory technology. High-school graduates performing high-complexity testing on the publication date of the regulations who do not have this level of education have 5 years to obtain an associate's degree while they continue working. Whenever they perform high-complexity testing, however, a general supervisor must be on site to provide direct supervision. In addition, persons who on the publication date of the regulations are qualified or could have qualified as technologists under the previous federal regulations continue to qualify as testing personnel for high-complexity testing.

QUALITY ASSURANCE

Each laboratory must establish and follow written policies and procedures for a comprehensive quality assurance (QA) program designed to monitor and evaluate the ongoing and overall quality of the total testing process. The regulations list specific requirements for assessing patient test management, quality control, proficiency testing, and personnel; comparing test results when a laboratory performs the same test by more than one method or at more than one site; correlating test results with patient information; rectifying communication breakdowns; investigating complaints; reviewing QA assessments with staff; and maintaining QA records.

CYTOLOGY REQUIREMENTS

Concern about the quality of cytology testing services, especially Pap smears, was important in prompting the passage of CLIA. Consequently, unlike the other laboratory subspecialties, the law contains specific standards for cytology. Because of this special emphasis on cytology, standards were set forth in the March 1990 regulations in advance of implementing other elements of CLIA. The final CLIA regulations refine and modify those standards on the basis of public comment and operational experience and contain specific requirements for cytology PT, QC, and personnel.

Cytology Proficiency Testing

CLIA requires the ``periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytologic preparations.'' To fulfill this requirement, the PT program is designed to test individual proficiency. It tests only for gynecologic cytology and requires that by 1994 each person engaged in examining gynecologic preparations be enrolled in a PT program and be tested once a year. Testing events will be conducted on site in each laboratory once per year and will typically be announced, although provision is made for unannounced events. Additional testing events will be conducted in each region or state to test persons who miss the on-site test or need to be retested.

The annual testing event consists of a 10-slide test set, which must be evaluated within 2 hours. The slides must be categorized into one of four diagnostic categories. Two test formats will be used: one for cytotechnologists and one for technical supervisors (pathologists). Pathologists who routinely evaluate slides after they have been screened by a cytotechnologist can be tested with slides after they have been screened by a cytotechnologist in the same laboratory. Cytotechnologists and pathologists who do initial slide screening are tested with unscreened slides. The scoring systems also differ and are based on whether the participant in the test is a cytotechnologist or a technical supervisor and also on the relationship of the result to a clinical condition.

The passing score for the test is 90%. A person will fail the test if he or she interprets as negative or benign even one slide that shows a high-grade lesion or cancer. Other types of interpretive errors are penalized less. A person who fails the examination must be retested within 45 days. If the person also fails the retest, the laboratory must provide him or her with remedial training and reexamine any gynecologic slides that he or she evaluates subsequent to the retest failure. Following remediation, the person may take a more rigorous second retest (third test), which consists of 20 slides. A person who fails this third test must refrain from examining gynecologic slides, and the laboratory must assure that he or she obtain intensive remediation in the form of a formally structured continuing-education program of at least 35 credit hours before another 20-slide test is attempted.

Since the cytology PT program is designed for testing individuals, laboratories themselves are not graded. The laboratory can be sanctioned, however, if it does not assure that its employees are tested or retested or provide required remedial actions following test failures. Sanctions can be intermediate or result in termination of certification or Medicare payments for gynecologic cytology.

Cytology Quality Control

The rules for cytology QC encompass slide staining, workload limits, result reporting and confirmation, error detection, and slide retention. Many of these requirements were specified in the statute, including the establishment of workload limits. The technical supervisor must establish and monitor the workload of each person who evaluates slides by a nonautomated microscopic technique. Persons can examine no more than 100 gynecologic and nongynecologic slides in a 24-hour period. This maximum slide number can be read in no less than an 8-hour workday, and persons who have other duties or who work part time must have their workload limit prorated by the number of hours spent examining slides. For calculating workload, each slide counts as one, except for those slides made by using liquid-based preparation techniques that result in cell dispersion over only half or less of the available slide area; such slide preparations count as half slides. Thus, if persons examine only slides prepared in this way during one 24-hour period, their effective absolute workload limit for that period would be 200 slides. If a person examines a combination of slides that count as half and as one, the absolute workload limit could be any number between 100 and 200 slides. The laboratory must keep records of the number of slides screened and the number of hours devoted to screening by each person during each 24-hour period.

Gynecologic slides interpreted to be reactive, reparative, atypical, premalignant, or malignant must be confirmed by a technical supervisor. The technical supervisor must also review all nongynecologic slide preparations.

The regulations specify components of an error-detection system that includes slide reexamination, comparison of cytology results with clinical information and histopathology results, and an annual statistical evaluation of the laboratory results and comparison of these statistics with those derived from each cytotechnologist's case reviews. The laboratory must reexamine a random sample (at least 10%) of the gynecologic slides interpreted by each cytotechnologist to be negative, including some cases from patients identified as being at high risk for cervical cancer. In addition, for each patient with a high-grade lesion or above, the laboratory must reexamine all available negative or normal slides from the previous 5 years.

The regulations specify that cytology reports must distinguish specimens that are unsatisfactory for diagnostic interpretation and must use narrative, descriptive nomenclature. All slides must be retained for 5 years; if they are loaned or referred before that time, the laboratory must maintain a record of the transfers.

Cytology Personnel

The personnel section of the regulations contains specific requirements for the technical supervisor in cytology, cytology general supervisor, and cytotechnologist. The technical supervisor must be a board-certified anatomic pathologist or cytopathologist. A person so qualified may delegate some of his or her responsibilities to a person in the final year of residency leading to board certification. The technical supervisor, in addition to performing the general responsibilities listed in the regulations, must also perform specific functions related to workload assessment, QC slide evaluation and confirmation, and PT.

The role of the cytology general supervisor may be filled by a technical supervisor or a cytotechnologist with 3 years of experience obtained within the preceding 10 years. The general supervisor is responsible for the day-to-day supervision of the cytology laboratory and for maintaining his or her own workload records.

The regulations establish new qualification standards for cytotechnologists, the persons who are responsible for screening slide preparations. To qualify as a cytotechnologist, a person must either have graduated from an accredited school of cytotechnology or be certified as a cytotechnologist. In addition, persons qualified under the previous regulations or those currently working as cytotechnologists who do not meet these new standards can qualify by alternative means on the basis of specific experience and training. Those persons working as cytotechnologists who do not meet the training or certification requirements may continue working for 2 years while pursuing the requisite training or certification to become qualified.

INSPECTIONS

DHHS or its designee, to assess compliance with all parts of the regulations, will conduct unannounced laboratory inspections. Inspections may also be part of a complaint investigation in laboratories issued a certificate of waiver, certificate, certificate of accreditation, or state-exempt laboratories. DHHS will also conduct sample validation inspections in laboratories accredited by an approved program and in states with approved licensure programs. Inspections will be conducted at least every 2 years in all other laboratories. During an inspection, the laboratory must allow the inspectors to have access to all areas of the facility, observe employees performing tests or other functions, interview employees, and review records. A laboratory that refuses to permit an inspection will be subject to suspension of its Medicare participation or loss of its CLIA certification.

CONSULTATION

DHHS will establish a committee of experts in the field of laboratory medicine, made up of persons involved in provision, utilization, and development of laboratory testing, called the Clinical Laboratory Improvement Advisory Committee. This committee will advise and make recommendations on the technical and scientific aspects of the regulations. This committee will review and make recommendations on a) the criteria for categorizing tests; b) personnel, patient test management, proficiency testing, quality control, and quality assurance standards; and c) other relevant issues. The committee will assist DHHS in keeping the CLIA regulations up to date with changing laboratory technology.

ADDITIONAL INFORMATION

The regulations for implementing CLIA (42 CFR Part 493) were published in the Federal Register as the following four separate sets of rules. The set of rules containing the laboratory standards, which is summarized in this report, contains the listed Subparts. All these regulations, after they become effective, will be consolidated and published in the Code of Federal Regulations.

To order copies of the Federal Register containing the CLIA standards for laboratories and the preliminary list of tests in the moderate- and high-complexity categories, send your request to:

U.S. Government Printing Office ATTN: New Order Desk P.O. Box 371954 Pittsburgh, PA 15250-7954 The cost for each copy (in paper or microfiche form) is $1.50; the mail-order cost (including postage and handling) is $3.50. Specify the date of the issue that you are requesting (February 28, 1992), your choice of paper or microfiche, and the stock order number (069-0042-4). Enclose a check or money order payable to the Superintendent of Documents. Credit card orders can be placed by calling the order desk at (202) 783-3238 or by fax to (202) 512-2250. In addition, you may view and photocopy the Federal Register at most libraries designated as U.S. Government Depository Libraries and at many other public and academic libraries throughout the country. The order desk operator can tell you the location of the nearest U.S. Government Depository Library.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.


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**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

 
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