CLIA '88 Regulations | ||||||||||||||||||||
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Summary of CLIA '88 ____________________________________________________________ A. GENERAL PROVISIONS (493.1 p 7139) .1 basis and scope .2 definitions of pertinent terms B. CERTIFICATE OF WAIVER (493.35 p 7142) .35 application for certificate of waiver .39 notification requirements C. REGISTRATION CERTIFICATE (493.43 p 7143) .43 application D. CERTIFICATE OF ACCREDITATION (493.55 p 7144) E. ACCREDITATION BY PRIVATE ORGANIZATION (493.501, not in original document) .501 general requirements - deemed status F. GENERAL ADMINISTRATION (493.602, not in original document) .602 scope .610 certificate requirements for laboratories H. PROFICIENCY TESTING (PT) (493.801 p 7146) .801 enrollment and testing of samples .803 successful participation .807 reinstatement after failure .821 Microbiology (includes Bacteriology, Mycobacteriology, Mycology, Parasitology and Virology) .823 Bacteriology .825 Mycobacteriology .827 Mycology .829 Parasitology .831 Virology .833 Diagnostic Immunology (includes Syphilis Serology, General Immunology) .835 Syphilis Serology .837 General Immunology .839 Chemistry (includes Routine Chemistry, Endocrinology and Toxicology) .841 Routine Chemistry .843 Endocrinology .845 Toxicology .849 Hematology (not subdivided) .851 Hematology .853 Pathology (includes Cytology limited to Gynecologic Exam) .855 Cytology; Gynecologic Examinations .857 Immunohematology (includes ABO Group and D (Rho) Typing, Unexplained Antibody Detections, Compatibility Testing and Antibody Identification) .859 ABO Group and D (Rho) Typing .861 Unexpected Antibody Detection .863 Compatibility Testing .865 Antibody Detection I. PROFICIENCY TESTING (493.901 p 7151) .909- 959 specific fixed criteria for each specialty .909 Microbiology .911 Bacteriology (gram stains; aerobic bacteria from urine, throat, cervical, urethral discharge; susceptibility. anaerobic bacteria) .913 Mycobacteriology (acid-fast stains, M. tuberculosis) .915 Mycology (dimorphic fungi, dermatophytes, aerobic actinomycetes) .917 Parasitology (wet mount parasites, concentration preps) .919 Virology (viral antigens, isolate virus) .921 Diagnostic Immunology (serology, general immunology) .923 Syphilis Serology (qual and quant determination) .927 General Immunology (AFP, ASOT, HBsAg, Mono, RA, Rubella .929 Chemistry (routine, endo, toxo) .931 Routine Chemistry (ALT, Blood gas, Urea Glu, etc. p7157) .933 Endocrinology (Thyroid, HCG Cortisol) .937 Toxicology (Alcohol, Carbamazepine, Digoxin, Lithium,etc p7159) .941 Hematology (Cell identification, WBC, RBC, pl, Hct, ESR, Fibrinogen, PT, PTT) .945 Cytology -Gynecologic Examination .959 Immunohematology (ABO) J. PATIENT TEST MANAGEMENT (493.1101 p 7162) .1101 patient test management .1103 specimen submission and handling .1105 test requisition .1107 TEST RECORDS (p 7162) .1109 TEST REPORT (p 7162) K. QUALITY CONTROL (QC) (493.1201 p 7163) .1201 general quality control .1202 moderate or high complexity QC .1203 moderate or high complexity QC .1204 facilities .1205 test methods,equipment,instrumentation, reagents, materials and supplies .1211 PROCEDURE MANUAL .1213 establishment and verification of method performance specifications .1215 equipment maintenance and function checks .1217 CALIBRATION and calibration verification procedures .1218 CONTROL PROCEDURES .1219 REMEDIAL ACTION .1221 QUALITY CONTROL RECORDS .1223-.1253 QUALITY CONTROL PROTOCOL (p 7167) .1225 Microbiology .1227 Bacteriology .1229 Mycobacteriology .1231 Mycology .1233 Parasitology .1235 Virology .1237 Diagnostic Immunology .1239 Syphilis Serology .1241 General Immunology .1243 Chemistry .1245 Routine Chemistry .1247 Endocrinology .1249 Toxicology .1253 Hematology .1258 Pathology .1255 Pathology .1257 Cytology .1259 Histopathology (tissue pathology) .1261 Oral Pathology .1263 Radiobioassay .1265 Histocompatibility (HLA) .1267 Clinical Cytogenetics (X, Y) .1269 Immunohematology (ABO) .1271 Transfusion Services M. PERSONNEL FOR MODERATE AND HIGH COMPLEXITY TESTING (493.1401 p 7172) .1401 general .1403 Director .1405 Director qualifications .1407 Director responsibilities .1409 Technical Consultant .1411 Technical Consultant qualifications .1413 Technical Consultant responsibilities .1415 Clinical Consultant .1417 Clinical Consultant qualifications .1419 Clinical Consultant responsibilities .1421 Testing Personnel .1423 Testing Personnel qualifications .1425 Testing Personnel responsibilities .1441 Director .1443 Director qualifications .1445 Director responsibilities .1447 Technical Supervisor .1449 Technical Supervisor qualifications .1451 Technical Supervisor responsibilities .1453 Clinical Consultant .1455 Clinical Consultant qualifications .1459 General Supervisor .1461 General Supervisor qualifications .1487 Testing Personnel .1489 Testing Personnel qualifications .1495 Testing Personnel responsibilities P. QUALITY ASSURANCE (QA) (493.1701 p 7183) .1701 quality assurance .1703 patient test management assessment .1705 quality control assessment .1707 proficiency testing assessment .1709 comparison of test results .1711 relationship of patient information to patient test results .1713 personnel assessment .1715 communications .1717 complaint investigations .1719 quality assurance review with staff .1721 quality assurance records Q. INSPECTIONS (493.1775 P 7184) .1775 inspections of labs issued certificate of waiver .1776 inspection of physician-performed microscopy .1777 inspection of other labs without certificates .1780 inspection of accredited and CLIA exempt T. CONSULTATIONS (493.2001 p 7185) ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ | |||||||||||||||||||
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J A O'Brien's discussions of CLIA '88 regulations,excerpted from her book COMMON PROBLEMS IN CLINICAL LABORATORY MANAGEMENT, McGraw Hill, 1999. FROM CHAPTER ONE ~ COMPLYING WITH CLIA '88 BACKGROUND History has taught us many lessons, so it is said; and to find the lessons taught to those in the clinical laboratory, one needs to delve into an historical perspective of legislation passed to regulate and guide laboratory testing. Under the Health Care Finance Administration (HCFA) recommendation, the Federal government established the CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA '88) so that all laboratory testing no matter where performed would meet certain standards of quality and accuracy, with minimum standards applied to all laboratories. According to CLIA '88, Laboratory means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings. A clinical laboratory is such a laboratory, and whether this laboratory is in a hospital, a free standing facility, or in a physician?s office, the regulations contained in CLIA '88 apply. From over ten thousand hospital and independent laboratories being regulated before 1988 under CLIA '67, there were now over one hundred and fifty thousand clinical laboratories regulated in the United States. An April 1998 figure from HCFA puts the total number of laboratories with CLIA certificates at 157,823. What was the lesson learned from these pieces of legislation? That the high standards of quality expected in the laboratory would now be mandated. The implication for the patient is important, for the accuracy of the test result would now be assured if laboratories complied with the regulations. CLIA '88 was an answer to the public concerns over the quality of laboratory testing, and a response to Congressional hearings that revealed deficiencies in unregulated laboratories, as physician office laboratories (POLs), and in PAP smear testing. The regulation replaced past standards with requirements that apply to all laboratory testing on human specimens. Standards for proficiency testing; patient test management; quality control; personnel requirements; quality assurance; and inspections were established. Also determined were procedures for applying for accreditation; fees for registration and procedures for sanctions if necessary. The application of the standards regulations depends upon the level of complexity of the testing in the laboratory. Three levels of testing complexity have been determined - waived, moderate and high-complexity. There are variations of some moderate complexity tests referred to over the last few years as Robust, Accurate and Precise Technology (APT), Provider Performed Testing (PPT), and Physician-Performed Microscopy (PPM), changed to Provider-Performed Microscopy (PPM) in April of 1995. Depending on the level of complexity of the test, varying regulations for quality control, maintenance, and personnel competency and training apply. The Centers for Disease Control (CDC) have responsibility for test categorization, namely determining the complexity and category of the test method. HCFA is the agency most directly involved with CLIA '88 implementation, namely approval of proficiency testing programs, accreditation programs and enforcement. Laboratories register with HCFA; obtain a certificate depending on the complexity of the testing performed in the laboratory; and pay appropriate fees. Laboratories also have the option of choosing an approved accreditation organization to satisfy the compliance with CLIA '88 regulations. No other piece of legislation in recent times has created such a deluge of writing, complaints and kudos. For those in the clinical laboratory, whether pro or con CLIA '88, this Final Rule has caused a problem as to whether its regulations can ever be satisfied. The solution to this problem is, of course, that the guidelines contained in CLIA '88 can be followed, and the laboratory will meet all criteria with some careful planning and implementation. OBTAINING CLIA '88 DOCUMENT INFORMATION Obtain a copy of the Federal Register containing the Amendments of 1988, from the United States Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954 requesting the Federal Register, Part 405, February 28, 1992. The 1992 original edition will include historical review and all comments and responses. It will be the document referred to throughout the book. There are other publications in the Federal Register covering clinical laboratories, for CLIA '88 is always being up-dated and what is called Final Rules today will be replaced or modified with the next set of Final Rules. The regulations adopted prior to October 1, 1995 are contained in 42 CFR Part 430 to end; this version may also be purchased from the Printing Office. Many organizations have published CLIA '88 in its entirety; in shortened abridged forms; and in booklets with annotated format. Merely look in the professional magazines and journals, to find advertisements for copies of CLIA '88 on disc, CD-ROM, or in print. | |||||||||||||||||||
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