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How to obtain a CLIA certificate without getting stuck in the details.

Welcome to the sticky world of HCFA's form 109. Prepare it with clinically strict accuracy. Believe it or not, the future of your laboratory depends on how well you fill out this form.

The word is certificate. it is your key to operating a clinical laboratory or doing testing anywhere in the United States after Sept. 1, 1992. You cannot operate any laboratory or testing site that does any tests on human specimens for medical reasons without a certificate. No testing site is exempt from these new requirements. Included is all testing done in physicians' office labs, nursing stations, health fairs, shopping malls, surgery suites, home nursing settings, and elsewhere. Here's how CLIA defines a laboratory (all indented quotations in this article are from the Federal Register of Feb. 28, 1992):

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. These

examinations also include procedures to determine, measure,

or otherwise describe the presence or absence of various

substances or organisms in the body. Facilities only

collecting or preparing specimens (or both) or only serving

as a mailing service and not performing testing are not

considered laboratories.

The sole basis for the certificate is the test itself and the complexity level that the Health Care Financing Administration has assigned to it. The certificate is issued to the lab, not to a person such as the owner or director.

The process begins by completion of HCFA form 109, "Information to Implement the Clinical Laboratory Improvement Amendments of 1988," of which representative sections appear throughout this article. Once filled out, form 109, which HCFA calls a questionnaire, describes the individual laboratory, including each specialty or subspecialty of test performed there. Each test and all methodologies used to perform it must be listed separately, by test. Appended to these is a list of every employee and his or her education and lab function.

Although HCFA mailed about 600,000 copies of form 109, some laboratories and testing sites failed to grasp the form's significance and "lost" it. If you need a copy, call HCFA's CLIA Inquiry Hotline at (410) 966-6801 or write to HCFA at the following address: CLIA Inquiry, P.O. Box 26687, Baltimore, MD 21207-0487.

In the Federal Register for June 12, 1992 vol. 57, pp. 25042-25059), HCFA announced its intent to replace form 109 with forms 114 (laboratory personnel), 115 (testing information), and 116 (general laboratory information). The idea is to reduce the amount of data that HCFA has to retain. The information to be provided All be essentially the same. In any case, until we have been officially notified about the new forms, we must us form 109.

The new rules, interpreting the Clinical Laboratory Improvement law and its amendments, were published in the Federal Register for Feb. 28, 1992 vol. 57, pp. 7001-7288). Copies are to be found in many regional, university, law, and reference libraries. These rules and the laws are commonly referred to as CLIA '88. The CLIA '88 amendments to the CLIA '67 law consist of 19 typed pages. The rules implementing the law are 727 typed pages long and include summary comments and responses, the actual rules, penalties for failure to comply, fees to support the system, and a listing of 5,000 tests and methods by assigned complexity. * Certificates. Four kinds of certificate, each valid for two years before renewal, will be issued according to test complexity done by the laboratory or testing site. A certificate of waiver permits the lab to perform only waivered tests. A certificate allows the lab to do either tests of moderate complexity or of moderate and high complexity in addition to waivered tests. A registration certificate is an interim certificate granted until HCFA can judge the lab's suitability for a full-fledged certificate. A certificate of accreditation, good for two years before requiring renewal, is issued by a nonprofit organization that has a program for laboratory quality deemed by HCFA to meet CLIA requirements.

CLIA '88 states the requirement for a certificate as follows:

... a laboratory will be cited as out of compliance with section

353 of the Public Health Service Act unless it has a

current, unrevoked or unsuspended certificate ....

A certificate of waiver authorizes the laboratory to do eight simple tests that have been judged by HCFA to have little potential for harm if the test is performed incorrectly. Specific tests cleared by the Food and Drug Administration (FDA) for home use are included among the waivered tests. Current waivered tests are listed in Washington Report, MLO, April 1992, p. 17. If your laboratory does these tests and no other, you should apply for a certificate of waiver. This will allow you to operate with a minimum of governmental oversight.

If you do any other test or tests and wish to continue to offer it or them, you must apply for a registration certificate. Then you can operate for up to two years, billing Medicare or Medicaid as appropriate, before obtaining a certificate. The billing method is irrelevant, however, in that you must have a certificate even if you do not charge anyone for a test; this system depends only on the test itself and its complexity assignment.

During the accreditation period, your laboratory will be evaluated for compliance with the requirements of CLIA '88. Compliance will be judged according to proficiency testing on the tests you do and inspection by CLIA inspectors. After your laboratory has been determined to be following HCFA rules, you will be issued a certificate appropriate for the tests that you listed on form 109. Remember, if you do even one high-complexity test, your laboratory must be authorized to do high-complexity testing. You must list all tests done in your laboratory even if you do them infrequently. In addition, you must find proficiency testing material from a HCFA-authorized program for all your tests or have a mechanism to show that the tests give valid results. (Such mechanisms will be discussed in a later installment of this series.) More than 145 tests named by HCFA must pass proficiency testing.

States can apply to HCFA for exempt status if their laboratory program is judged as being at least as stringent as CLIA rules. Whether such applications are to be made by state health departments or other agencies has not been specified. in these exempt states and under the states' rules, laboratories will be issued a license rather than a CLIA certificate.

The main issues concerning your certificate are the differing requirements for personnel and the type of data and information you need for each method employed in your laboratory. Labs holding any type of certificate, including a certificate of waiver, are required to do the following:

1. Pay the appropriate fee;

2. Comply with the rules for the certificate;

3. Permit inspections, usually unannounced (even for certificates of waiver or accreditation);

4. Notify HCFA within 30 days of any change in ownership, name of facility, location, or director, and, in labs where high-complexity tests are performed, supervisors;

5. Handle proficiency testing specimens in the same manner as patient specimens (note, however, that no proficiency testing is required for waivered tests);

6. Be subject to any penalties that are specified for noncompliance;

7. Make all records and related documents available to HCFA during inspections;

8. Notify HCFA within six months of adding a specialty, subspecialty, or additions to or changes in test methodologies (labs with certificates only);

9. Have a director and testing personnel; and 10. Follow the manufacturer's instructions for each test or perform it as required by the CLIA rules.

In addition, laboratories approved to do tests of moderate complexity must employ technical consultants. Laboratories doing tests of high complexity must employ supervisors, clinical consultants, and a general supervisor. Whether this person is to be employed in that capacity part time or full time is not stated. * Optimizing your application. Because CLIA '88 requires less education and experience for the director, consultants, supervisors, and testing personnel in labs performing tests of moderate complexity, you may decide that your laboratory should maintain a certificate only for such tests. Anyone who will report patient test values must be specifically qualified by education and training and authorized by the laboratory director to do the test. if the personnel at your laboratory or testing site have limited education or experience, and if you are unable or unralling to hire workers with more advanced education or expertise, you may have to limit the complexity of testing that you do.

In general, CLIA rules for tests of moderate or high complexity are the same regarding these five major factors: patient test management, quality control (after September 1994), quality assurance, proficiency testing, and inspections. The only long-term difference mandated for certificates for high- and moderate-complexity testing relates to personnel requirements for education and experience. * Think hard. Be careful when determining your lab's complexity level. A certificate of waiver is issued for only the eight waivered tests. Any modifications in the manufacturer's instructions or deviations from them will require a certificate. The CLIA '88 rules published Feb. 28, 1992, include a list of approximately 5,000 test and methodology/instrument combinations, listed by moderate or high complexity. This list, which by September of this year will be doubled to 10,000 combinations, is intended to help laboratory managers identify which methodologies may be used to maintain a certificate for tests of moderate complexity.

The complexity classification of each test methodology or instrument is determined by evaluating a seven-item list on a three-point system. Low scores are given if the test requires little detailed knowledge or training, is simple to perform, and uses stable reagents, calibrators, and controls. it also must be done on an instrument that is automated, including preventive maintenance. A total of 12 points or less classifies the test as moderately complex - by far the largest category, encompassing approximately 75% of all methods. Any test that has not been specifically waived or classified as moderately complex is considered to be of high complexity. Classification for new tests and reclassification of existing ones will be reviewed by HCFA through a technical advisory committee that will meet at least once a year.

The tests listed for a certificate of waiver are very specific. For example, a glucose meter that has not been cleared by the FDA for home use will require a certificate for tests of moderate or high complexity, depending on the HCFA classification. The test system for occult blood is sometimes used for other fluids, such as sputum and pleural fluid. If you use these other specimens, your lab will require an appropriate certificate.

A lab that holds a certificate and wishes to change a test or add one to its menu must notify HCFA within six months after reporting the first patient test result from the new or altered test. The lab may, however, spend an unlimited amount of time developing or installing the test before the six-month clock starts. Holders of certificates of waiver must notify HCFA before reporting patient test results for any nonwaivered test. * Plan. CLIA '88 requires procedures, policies, and documentation for every aspect of lab work. Each laboratory should therefore develop protocols for changing methods so they will be in place when needed. Such policies should set forth the laboratory's goals for maintaining the test complexity required.

Another reason it's wise for many labs to hold a certificate of moderate complexity is the evaluation data required for quality control of each method. This involves more than running replicate assays of QC materials. For the next two years, labs doing tests of moderate complexity without any modification may use the manufacturers' instructions, assuming these have been cleared by the Food and Drug Administration through either the 510 (k) or the pre-market approval (PMA) process. Tests of high complexity and all tests modified by the individual laboratory, however, require data verifying or establishing accuracy, precision, minimal detectable limit (analytical sensitivity), interfering substances (analytical specificity), reportable range, and reference (normal) ranges. After September 1994, the manufacturer can obtain clearance from FDA that their instructions and procedures meet the quality control requirements of CLIA '88. It has been announced that this clearance procedure will be published by the FDA by September 1992.

The rules for each complexity level apply to the individual tests themselves, not to the level of complexity achieved by the facility where they are performed. A laboratory that has a high-complexity certificate may do waivered tests without following the personnel requirements, director qualifications, or proficiency testing required for tests of greater complexity. These tests must be listed on the laboratory's certificate.

It's critical that your proficiency testing values be judged against the correct methodology. To make sure that is done, maintain a complete list of tests by methodology so that you can accurately specify what method was used for your lab's proficiency testing. This list is to be kept current by the technical supervisor. The lab director must approve which tests each staff member may do and which each supervisor may supervise. The following is quoted from the director's responsibilities:

(12) Ensure that prior to testing patients' specimens, all personnel

have the appropriate education and experience, receive

the appropriate training for the type and complexity

of the services offered, and have demonstrated that they

can perform all testing operations reliably to provide and

report accurate results;

(15) Specify, in writing, the responsibilities and duties of

each consultant and each supervisor, as well as each person

engaged in the performance of the preanalytic, analytic,

and postanalytic phases of testing, that identifies

which examinations and procedures each individual is authorized

to perform, whether supervision is required for

specimen processing, test performance or result reporting

and whether supervisory or director review is required prior

to reporting patient test results.

* Traps to avoid. Keep in mind that HCFA's form 109 is the basis for determining what kind of certificate your laboratory will be required to have. For example, if existing personnel limit you to moderately complex testing, be sure you are doing only tests of moderate complexity - in which case you may have to change methods and correct the tests listed on form 109 before Sept. 1, 1992. If you fail to do this, you may be trapped into requiring a certificate for tests of high complexity and the personnel required to provide these tests.

The date is key because tests done in your laboratory as of the effective date of implementation of the rules (Sept. 1) will be grandfathered regarding data required for performance characteristics. The tests themselves are not grandfathered regarding their assigned complexity level or personnel required to direct, supervise, and perform them.

Another potential bog of quicksand is that for all tests listed on form 109, you will be obligated to do successful proficiency testing and to prepare data and records for inspection. In brief, if your lab does a test, you must list it on form 109. if you are not actually doing a test entered on the form, you may fail inspection or proficiency testing requirements. To avoid having to prepare a raft of documentation establishing claimed versus actual performance characteristics, make sure that before Sept. 1 of this year your laboratory is doing all the tests you have listed on the form. * Attend to the complexity model. A CLIA certificate limits the tests and methods your laboratory is allowed to do. Every testing and supervisory staff member must be qualified by education and specific training to do the tests he or she performs and must furthermore be authorized by the laboratory director to supervise or perform each test that the complexity model allows him or her to do.

The certificate you acquire obliges you to pass proficiency testing for all available tests or to validate the method in another way. Inspectors will gauge the extent of your compliance with the complexity model as limited by your certificate and your use of qualified and authorized personnel only. How you begin operations under these very specific and limiting rules will determine the long-term success of your laboratory.
COPYRIGHT 1992 Nelson Publishing
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Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
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Title Annotation:Copin with CLIA, part 1; Clinical Laboratory Improvement Amendments of 1988
Author:Passey, Richard B.
Publication:Medical Laboratory Observer
Article Type:Cover Story
Date:Aug 1, 1992
Previous Article:Self-referral controversy boils anew.
Next Article:Selecting instruments with an eye to CLIA.

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