How to read the Federal Register and other CLIA-related documents.
IN ORDER TO OBEY the final administrative rules of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), you must have a reading knowledge of two different types of Federal documents: the Federal Register and the State Operations Manual. Both will strongly affect your ability to understand and comply with these complex rules. You should also become familiar with the law itself and with a number of other laws and executive orders that have an impact on laboratory operation.
The Omnibus Budget Reconciliation Act (OBRA) of 1989 required CLIA '88 to combine all regulations for interstate commerce, Medicare, Medicaid, and all laboratories under a recodified title 42, part 493, of the Code of Federal Regulations. This codifying of Federal administrative rules has the effect of law. In other words, we must all obey them. The appearance of CLIA '88 boiled down laboratory regulations into a single set. Although they are finally consolidated, that doesn't make them easier to read.
Laboratories in the United States are now regulated under CLIA '88 by test complexity rather than by where the test is done. Before CLIA '88, the set of regulations we followed differed by site, whether an independent, hospital, or physician's office laboratory (the last being largely unregulated at that time). The rules now required by the Health Care Financing Administration (HCFA) for implementing CLIA '88 (Federal Register, vol. 57, Feb. 28, 1992, pp. 7001-7288) are very different from those made final for CLIA '67 when published just two years ago (Federal Register, vol. 55, March 14, 1990, pp. 9577-9610). Carefully read these new rules so that you can implement them successfully.
* Some background information. The Federal Register is the official publication of the Office of the Federal Register, National Archives and Records Administration. Published on a daily basis, the large-format paperback volumes, often quite hefty, provide a uniform mechanism for disseminating general-interest documents from the Federal government, legal announcements and regulations issued by Federal agencies, documents required by acts of Congress, Presidential proclamations, and executive orders. You may view copies of this material at many major libraries or order individual copies for $3.50 each (smaller issues cost $1.50). Order via credit card over the telephone or prepaid by money order, indicating the date of publication, from the Superintendent of Documents, United States Printing Office, Washington, DC 20402-9325, (202) 783-3238.
Subscriptions and copies can also be obtained on microfiche. The citation used for a Federal Register document is the volume number followed by "FR" and the inclusive page numbers. For example, 57FR 7001-7288 refers to the entire CLIA regulations published on Feb. 28, 1992. The same issue contains other items as well, both before and after CLIA.
The State Operations Manual (SOM) is a large tome meant for surveyors (inspectors). This manual is published periodically (with date of publication for each edition) by the Department of Health and Human Services. Only Appendix C is directly applicable to the clinical laboratory. You can order a copy of Appendix C of the SOM (which at press time was expected to become available in early fall 1992) from the National Technical Information Service at (800) 553-6847. Request product number PB92146174, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services--Appendix C. The price is $35.00 prepaid or by credit card over the phone. If you would like to be billed by invoice, add $7.50.
This manual gives instructions and guidelines to surveyors who will conduct inspections of laboratories for compliance with Federal requirements according to the law, the administrative rules from the Federal Register, and instructions found in the SOM. Be sure to order and use the new edition of the SOM, for the March 1991 issue, designed for CLIA '67, is seriously out of date. HCFA is currently preparing a version specifically to cover enforcement of CLIA '88. Advance copies were sent to some professional societies and certain individuals. The final version should appear at approximately the time this issue of MLO is published.
Some requirements found in the SOM are not found in the law or in the published administrative rules. These additional requirements for inspectors will cause many laboratories problems when HCFA surveyors (inspectors) expect labs to be following rules they may never have heard of. This manual outlines the inspection process, including the regulations listed by numbered section (e.g., 493.1200), guidelines for their interpretation, and probes seeking information from the laboratory. A probe is a question that requires data or documentation from the laboratory.
Tag numbers used by surveyors to indicate citations of the laboratory are listed. Each tag number relates to specific rule deficiencies; the numbers thus serve as a shorthand method for surveyors. Since the proposed version of the State Operations Manual for CLIA '88 contains nearly 1,300 tag numbers, a surveyor could cite a laboratory for nearly 1,300 kinds of failure or problem--a sobering thought. The proposed State Operations Manual Appendix C presents more than 200 guidelines for interpreting the administrative rules and has over 120 probes, many of them complex, that guide surveyors toward specific information. This is why you should become familiar with the State Operations Manual.
* How the rules came about. Governmental oversight of clinical laboratories started with the Clinical Laboratory Improvement Act of 1967 (CLIA '67), which regulated independent laboratories and laboratories billing Medicare or Medicaid. After a law is passed by Congress and signed by the President, Federal agencies assume responsibility to propose and make administrative regulations (rules) to implement the law's requirements. The administrative rules for CLIA '67 were delayed until March 14, 1990, when they were made final as published in the Federal Register on March 14, 1990 (vol. 55, pp. 9577-9610). Even before the rules for CLIA '67 were proposed and finalized, Congress passed public law 100-578, the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). It was signed into law on Oct. 31, 1988.
Heavy Congressional pressure caused the rules for CLIA '88 to be proposed in the Federal Register in several sections from May 21, 1990, through April 2, 1991. These proposed rules were patterned after the very difficult and onerous CLIA '67 rules and sparked over 60,000 letters of comment from affected laboratorians. HCFA, the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA) read and evaluated these comments. They then modified the rules to bring them into compliance with the law after considering the public comments. When published with comments on Feb. 28, 1992, the rules were considered final but the public was allowed to submit comments for future consideration--and 16,000 such letters were received.
These rules, which began to be implemented on Sept. 1, 1992, and will be fully implemented by 1997, allow a delay in compliance with some of the regulations. Able to be delayed for two years are (1) issues involving the kind and amount of data required before new methods can be introduced in a laboratory and (2) aspects of proficiency testing for newly regulated laboratories. Compliance with regulations for testing personnel who are doing tests of high complexity but whose most advanced formal education consists of a high school diploma or equivalent may be delayed for five years.
A third document is the Clinical Laboratory Improvement Amendments law. To give you some perspective, in ordinary typewritten pages the law is 19 pages long, while the laboratory regulation portion as published on Feb. 28 of this year is 195 pages. (The entire set of four documents consists of more than 700 pages.) The proposed State Operations Manual is more than 300 pages. In other words, the 19-page law is implemented by 195 pages of administrative rules that are further explained by 300 pages of instructions to surveyors.
Other laws and executive orders relating to CLIA '88:
1. The Social Security Act. Sets the foundations for payment from the Federal government and is the doorway for much of the content of these regulations.
2. Omnibus Budget Reconciliation Act of 1986 (Public Law 99-509, Section 6141). Sets forth the requirements for laboratory directors.
3. Omnibus Budget Reconciliation Act of 1989 (Public Law 101-239). States that all labs will be regulated under CLIA '88.
4. Public Health Services Act Section 353. Was revised by CLIA '88.
5. Executive Order 12291. Requires a regulatory impact analysis of all major rules. (A projected economic impact of $100 million or more requires such an analysis.)
6. Executive Order 12564 and section 503 of Public Law 100-71. Established rules for National Institute on Drug Abuse (NIDA); approved drugs-of-abuse testing in clinical laboratories.
7. Executive Order 12612. Requires a Federal assessment of the impact of administrative rules on the relationship of the states and Federal government.
8. Regulatory Flexibility Act (5 United States Code 601-612). Requires an analysis of impact on small entities (e.g., small rural hospitals).
9. Paperwork Reduction Act of 1980. Required to help assess the impact of any mandated HCFA-directed plan of action.
The regs implementing CLIA '88 that were published on Feb. 28 of this year appeared in four parts, most in final form with comments. The parts are designated:
TABULAR DATA OMITTED
On July 31, 1992, rules for accreditation programs including requirements for state-exempt programs were published in the Federal Register. States and nonprofit organizations may propose lab certification programs to HCFA that are at least as stringent as those required by CLIA '88. States whose programs are approved will be exempt states. In other words, all labs in these states will be exempt from enforcement by HCFA--but 5% of these labs will be reinspected by HCFA at random.
Complexity assignments for an additional 2,000 instrument--method combinations were published in the Federal Register, vol. 57, July 8, 1992, pp. 30362-30377. Still to be published at press time (but promised for September 1992) are complexity assignments for an additional 3,000 such combinations. The FDA will publish requirements for approving manufacturers' procedures for quality control, calibration, and maintenance. Technical corrections and additions to the regulations will be published as needed.
* Slogging through jargon. The CLIA '88 rules are very difficult to read. They are printed in a small typeface on newsprint that smudges easily. The material is highly redundant because of a perceived need to repeat all rules appropriate to each situation. Especially redundant are the comments and responses, rules for proficiency testing, and personnel qualifications.
The rules are rife with unexplained abbreviations and jargon. The many citations for 42 CFR part 493, for example, refer to title 42 of the Code of Federal Regulations, of which part 493 is the regulatory portion of the public health regulations for clinical labs. Each subpart of the CLIA '88 rules is designated by a letter; under the letters are numbered paragraphs, called subsections, preceded by the standard symbol for section.
Each numbered paragraph is made in outline format so that each subportion of the outline applies to the section above it. An item down to the smallest magnitude might be numbered 493.2000(a)(1)(i)(A)(1)(A). Note that the last two identifying labels appear in italics. To understand the rules, read them in paragraphs.
The example in Figure 1 is taken from 493.1423 Standard; Testing Personnel qualifications for laboratories performing moderate-complexity testing (found on page 7175 of the Federal Register, vol. 57). This example is presented in outline form to demonstrate how much easier it is to read than in Federal Register format. Reading this section of the rules, like many other portions, can be confusing unless you realize the subportion order is (b)(4)(ii)(A).
The body of CLIA '88 rules is organized into subparts of 42 CFR part 493. Each subpart is a separate lettered section of the document. Most begin with a new series of decimal numbers (e.g., 493.1200 Quality Control; 493.1400 Personnel). The subpart letter designations are not consecutive because some (E, F, G, L, N, O, R, and S) have been reserved for future use. The Table of Contents for the CLIA '88 rule at page 7138 lists Subpart F General Administration, although this part of the rules was not published at that time. The subparts of CLIA '88 are listed in Figure 2.
Condition level and standard level are the two levels of rules. The former are more general and carry more severe penalties for violation. In many places the rules refer to other sections by number only. This requires flipping back and forth through the regulations to understand their intent. For example, 493.1221 (Quality Control records) is referred to 35 times in the CLIA '88 rules; 493.1201 (Condition: General quality control) and 493.1449 (Standard: Technical supervisor qualifications) are each referred to 34 times; and 493.15 (Laboratories performing waived tests) and 493.1257 (Condition: Cytology) are each referred to 32 times.
A convenient way to grasp the intent of the regulations is to read the section in which HCFA summarizes and explains major points raised in the 60,000 comment letters (pp. 7009-7027). A further delineation of the requirements for your laboratory will be found in the State Operations Manual.
These long, complex regulations include many interesting and important portions. The only way to comprehend them fully is to read and reread them. Force yourself to slog through the material. If you don't allow yourself to become discouraged, you will eventually come to understand how the rules should work, what you are required to do (and when), and how to insure successful compliance by your laboratory. The sooner you become closely familiar with the regulations, the better you can accomplish this.
A typical section of the Federal Register, presented in outline form
493.1423 Standard; Testing Personnel qualifications.
Each individual performing moderate complexity testing must--
(a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the state in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or
(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or
(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks' duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or
(4) (i) Have earned an academic high school diploma or equivalent; and
(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has--
(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;
(B) The skills required for implementing all standard laboratory procedures;
(C) The skills required for performing each test method and for proper instrument use;
(D) The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies and procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.
The author is director of clinical chemistry at Oklahoma Medical Center, Oklahoma City. Under the aegis of the National Committee for Clinical Laboratory Standards (NCCLS) and the American Association for Clinical Chemistry (AACC), he has presented workshops around the country on the final CLIA regulations since early 1992 and on CLIA '88 in general since 1990.
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|Title Annotation:||Clinincal Laboratory Improvement Amendments|
|Author:||Passey, Richard B.|
|Publication:||Medical Laboratory Observer|
|Date:||Oct 1, 1992|
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