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A master plan for implementing CLIA.

It will take fancy footwork to waltz around the floor without tripping. You can do it smoothly by following a series of logical steps.

TO IMPLEMENT the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) successfully and efficiently, your laboratory needs a master plan. The rules, modified in light of 60,000 comment letters received by the Health Care Financing Administration, represent a less repressive regulation than CLIA '67. Nevertheless, it's complicated to run a clinical laboratory under the demands of the rules. To simplify the process, draft a stepped plan in which each part builds on the previous ones. This approach will help you avoid repeating steps unnecessarily as you develop and record the required data.

* Step 1: Authorizing personnel. An orderly plan begins with an evaluation of the education and experience of laboratory personnel. From this listing, you can determine whether employees meet the educational and experience requirements for director, technical consultant (supervisor), clinical consultant, general supervisor (for highly complex testing only), and testing personnel.

Available personnel determine the complexity of testing that a laboratory can perform. Most laboratories will want to qualify for a certificate for moderate-complexity testing. The main reason is that the requirements for education and experience are much less rigorous for employees who perform tests of moderate complexity than for those who perform tests of high complexity. Seventy-five percent of commercial tests are classified as moderately complex. If you determine later that your lab will be able to operate only under a high-complexity certificate, you may have to recruit the requisite personnel.

* Personnel. The following four items relating to personnel are taken from CLIA '88 rules as published in the Federal Register on Feb. 28, 1992.

1. Identify the laboratory director (as defined in |Secs~493.1401,-.1441,-.1405, and -.1443). Establish his or her duties. According to CLIA '88, the laboratory director is responsible for all laboratory activities; surveyors will look for evidence of active participation in the many duties specified in the regulations (|Sec~493.1407 and -.1445). Be sure to resolve any confusion resulting from discrepancies between the titles specified by CLIA and those that are routinely used in your laboratory. Such differences may confuse the line of authority in the laboratory, which must be firmly established; neither a director nor a technical supervisor can function without it. Clear lines of authority fortify the impact of instructions given to all laboratory personnel (|Secs~493.1401-.1495).

2. The Laboratory Director must specify in writing the duties of each member of the lab staff as specified in the Feb. 28, 1992, Federal Register and excerpted below.

(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, and identify 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.

--Standard; Laboratory director responsibilities: Moderate complexity testing, |Sec~493.1407 (e)(14), p. 7173; High complexity testing, |Sec~493.1445 (b)(15), p. 7175

In other words, the director must name and specify duties for technical supervisors, clinical consultants, general supervisors, and testing personnel. All this must be done before the laboratory issues any test reports.

3. List all testing personnel by name, with qualifications (education and training), and use this information as the basis for deciding what tests each person may do. The completed list will assist you in documenting the competence of testing personnel, which under CLIA must be done semiannually for the first year and annually thereafter.

4. Divide paperwork and other CLIA-related tasks among appropriate staff members. Some materials will have to be created for each laboratory section; some will encompass the laboratory as a whole.

* Step 2: Test menu and performance specifications. Establish the test menu to be offered by your laboratory and used to determine training requirements for personnel and performance specifications for each test. Fortunately, you already have lists of all tests and relevant methods and of categories of key personnel, including their educational backgrounds, because you had to prepare them for HCFA's comprehensive form 109 and for the forms intended to replace it: 114 (Laboratory Personnel Report), 115 (Testing Information), and 116 (Laboratory Information).

Performance specifications are required for each quantitative test by CLIA's requirements for quality control. Required specifications include accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range, and other pertinent parameters (|Secs~493.1205, -.1213, and

-.1219). The laboratory must be able to present performance evaluation procedures and data demonstrating, verifying, or establishing them.

Laboratory data must support the effectiveness of these performance specifications and operating policies--and that the laboratory can operate within them. Quality control requirements for tests of moderate complexity will differ from those for tests of high complexity until the FDA provides manufacturers with clearance stating that the test labeling (method insert sheets) meets requirements for QC procedures under CLIA '88. For now, therefore, different types of data are required for high- and moderate-complexity tests. For every method that is of high complexity or developed in-house, and for every test modified in any way, you must establish the performance specifications and be able to produce data showing that you are operating within these specifications. (A later article will expand on this.) Otherwise, for moderately complex tests cleared by the FDA through the 510(k) or pre-market approval (PMA) processes for in vitro diagnostic use, you can follow the manufacturer's instructions and performance specifications. If the manufacturer cannot provide instructions for a required specification, you will have to establish the specification(s) yourself.

* Step 3: Policies and procedures. The most onerous work to be completed for full compliance with CLIA is the writing of policies and procedures. The policy and procedures should make it clear throughout that quality has been built into the laboratory system and is monitored for effectiveness. CLIA's quality assurance rules require that any breaches in quality must be detected, any problems related to policies or procedures corrected, and data gathered afterward to demonstrate that the modifications were and are effective.

All policies and procedures should be up to date. Testing personnel are required to solve problems by following policies and procedures, as stated in |Sec~493.1425(b)(4) and (5) and in |Sec~493.1495(4) and (5).

Policies set the direction and functions of the lab. Procedures, used to implement policies, list specific steps required to meet the stated purpose. It is essential to write policies and procedures that meet the intent of CLIA.

The people chosen to put your policies into words should write in an organized fashion and be closely familiar with your laboratory's operations. Once the policies are on paper (or computer), a great many procedures will have to be written to implement them.

Use terminology with which HCFA's surveyors (inspectors) will be familiar. If it isn't feasible in any instance to follow CLIA's rules, specify in your policies and procedures what you do instead and be ready to provide data demonstrating that your substitute works equally well.

CLIA's rules allow you to write your own policies if you can show evidence of their effectiveness, as follows:

Each laboratory performing moderate or high complexity testing, or both, must establish and follow written policies and procedures for a comprehensive quality assurance program which is designed to monitor and evaluate the ongoing and overall quality of the total testing process (preanalytic, analytic, postanalytic). The laboratory's quality assurance program must evaluate the effectiveness of its policies and procedures; identify and correct problems; assure the accurate, reliable, and prompt reporting of test results; and assure the adequacy and competency of the staff. As necessary, the laboratory must revise policies and procedures based upon the results of those evaluations. The laboratory must meet the standards of this subpart as they apply to the services offered, complexity of testing performed and reported, and the unique practices of each testing entity. All quality assurance activities must be documented.

--Condition; Quality assurance: Moderate or high complexity testing, or both. |Sec~493.1701, p. 7183

Also required are QC policies, including those for operating limits, proficiency testing, calibration, and calibration verification. Operational policies must establish turnaround times and requirements for specimen preparation and handling. Some of this information can come from manufacturers' materials for testing systems, instruments, or reagents. (You may use product inserts, perhaps inserted in clear plastic sheet protectors, as part of your official procedure.) Qualitative or semiquantitative tests must have methods to verify their quality, as stated in |Sec~1218 (b) (5).

* Step 4: Keep the required records. Four categories are involved: personnel, quality control, quality assurance, and proficiency testing.

Personnel records should include the employee's application form, job description, assigned duties, and documentation of education at the high school level and above. The record should include specifics of training and experience, including bench and supervisory duties. Document the person's authorization to do specific tests. If appropriate, specify which supervisory duties the employee may carry out.

Quality control records should list each method and its performance specifications. These records should include calculations of mean and standard deviation (|Sec~493.1218), which can help identify proper performance. Data must document that performance is within the stated specifications for accuracy, precision, analytical sensitivity, analytical specificity or freedom from interferences, reportable range, and reference range.

Quality assurance records should show that the laboratory's policies help meet your customers' (that is, physicians' and patients') needs. These records should show evidence of active review and problem solving, including a description of precisely how the problem was resolved so that it would not recur. All known negative patient outcomes must be investigated; effective solutions must be applied and documented.

Especially critical is the documentation of how any proficiency testing failure uncovered in your laboratory was resolved. You should identify each such problem and show that the solution used was effective.

* Be complete. Creating and following a master plan will help you implement CLIA's detailed and difficult rules successfully. Incorporate into your plan all elements required by CLIA. Carefully make assignments to establish accountability. Track progress so that you will be prepared for your biannual HCFA survey. In the process, you are likely to find that your department is more organized than ever and that quality has been instilled more deeply into your laboratory system.

Richard B. Passey, Ph.D., is professor of pathology, University of Oklahoma Health Sciences Center, and director of clinical chemistry, Oklahoma Medical Center, Oklahoma City. He has been presenting workshops on CLIA for several years under the aegis of the National Committee for Clinical Laboratory Standards and the American Association for Clinical Chemistry.

Physicians' office laboratories: Special considerations

Physicians who have at least one year of experience as directors of their own laboratories and wish to be listed as technical consultant for HCFA purposes must be able to document that their experience qualifies them to be so named. They will nevertheless seek outside advice in resolving certain technical problems. This advice can be obtained from manufacturers of instruments or reagents or from consultation groups set up especially for this purpose. If a physician lab director finds that the duties of a technical consultant are adversely affecting his or her medical practice, a technical consultant can be hired to assist permanently, temporarily, or part time. HHS Secretary Louis Sullivan recently stated that POL inspections will be announced in advance to avoid disturbing direct patient care.

* Step 1. Even if your laboratory has limited help, you must begin the work now by doing the four most important parts first: authorize personnel to do testing and organize quality control, quality assurance, and proficiency testing activities. Drawing up a list of tasks and assignments will help guarantee compliance. (Such a list may have the side benefit of documenting for your employer that you need additional personnel.)

* Step 2. To play successfully in the proficiency testing arena, you must develop and maintain detailed performance specifications, which set the standard by which the laboratory operates. Smaller laboratories can establish these specifications after consultation with the manufacturer of the testing system. The specifications must reflect the quality necessary to meet medical needs and to be successful in proficiency testing.

* Step 3. Remember that although you should strive to meet the intent of the CLIA regs, you retain responsibility for setting the policies to be followed in your laboratory. Furthermore, don't waste time writing policies for activities that are not performed in your laboratory.

* Step 4. Obtain data demonstrating that you can achieve the performance specifications you established in step 2. It will probably not be necessary to supply large amounts of data.

Policies you must write, follow, and document

Patient test management (|Secs~1101-.1111)

Patient preparation; specimen collection, transport, processing, positive identification (|Sec~493.1101)

Specimen submission, referral of specimens, instructions for specimen collection (|Sec~493.1103)

Required information for test requisition, written requests from an authorized person, information required for requisitions, record retention (|Sec~493.1105)

Test records, including identification of patient; a log of testing, with instrument printouts attached; name(s) of personnel who did the test and reported the results; notes about any rejection of specimens; record retention (|Sec~493.1107)

Test reports sent promptly and confidentially to the authorized person; record retention; name and address of the laboratory that did the test; reasons for specimen rejection (if applicable); reference ranges; any results indicating life-threatening situations; list of tests available from the laboratory, including performance specifications and interpretive guidelines (|Sec~493.1109)

Referral of specimens only to laboratories holding CLIA '88 certificates for the appropriate specialty or subspecialty and level of complexity required (|Sec~493.1111)

Quality control functions (|Secs~493.1201-.1269)

High-complexity tests and modified tests must follow all quality control policies (|Sec~493.1202).

Note: Labs using moderate-complexity test kits cleared for in vitro diagnostic use by the FDA through 510(k) or PMA have some relief and may follow the manufacturers' instructions. They must still follow a procedure manual, calibrate each method at least once every six months, document the use of two levels of controls, perform and document specialty and subspecialty control rules, and perform and document remedial actions.

If manufacturers' instructions follow CLIA's QC requirements, they may be used; otherwise, the laboratory must establish criteria that do. (|Sec~493.1203)

Policies for facilities must insure adequate space, environment, and utilities for all phases of testing. (493.1204)

Sufficient and appropriate test methods, equipment, instrumentation, reagents, materials, and supplies must provide accurate and reliable test results. Additional policies required: definition of the conditions required for specimen storage; specifications for laboratory utilities and environment; documentation of remedial actions; rules for not using out-of-date reagents; and documentation of effects of reagent lot numbers on calibration (|Sec~493.1205)

Written procedure manual must contain 16 specific items. They may utilize manufacturers' package inserts, but any items not covered in the inserts must be furnished by the laboratory. The original manual and changes must be signed by the director and retained two years after being updated or discontinued. (|Sec~493.1211)

For tests introduced on or after Sept. 1, 1992, establish and verify method performance specifications before reporting relevant patient test results. FDA clearance for CLIA quality control rules and demonstration of performance may be substituted for the specifications regarding accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference range(s). Other performance characteristics may be required for test performance. Policies must establish calibration and control criteria with procedures. (|Sec~493.1213)

Document equipment maintenance and checks, which must include electronic, mechanical, and operational functions. Maintenance instructions from the manufacturer that are unmodified or have been cleared by the FDA and meet CLIA requirements may be followed. Otherwise the laboratory must establish and demonstrate the effectiveness of maintenance procedures, including adherence to established limits. (|Sec~493.1215)

Documented calibration and calibration verification procedures must insure accuracy and establish the reportable range. Manufacturers' calibration instructions cleared by the FDA as meeting CLIA's general QC requirements may be used if provided. Otherwise the laboratory must establish calibration requirements and must schedule and specify the calibration materials to be used for calibrations that meet at least four conditions: They must be appropriate to the assay, contain the correct number of calibrators, have the appropriate concentrations, and have values traceable to reference methods or to reference materials. (|Sec~493.1217)

Control procedures must assess the accuracy and precision of patient test results. Manufacturers' instructions cleared by the FDA as meeting CLIA '88 quality control requirements may be used if they require testing in the same manner as patient specimens; if means and standard deviations are calculated for each lot number of controls and calibrators; or if they establish and verify target values and the control limits that must be met before patient test results are reported. Criteria for checking the reactivity of reagents and supplies must include positive and negative reactions and be documented. Policies must insure that the rules apply to stains and culture media. For any method that has not been cleared by the FDA, that deviates from the manufacturer's instructions, or that has been developed in-house, the stability of the test system and operator variance in determining the number, type, and frequency of calibration and control procedures must be evaluated. These procedures are to include, where applicable, positive and negative controls; or, for quantitative tests, two controls for each run of patient specimens. If calibration and control materials are not available, the laboratory must have an alternative mechanism to assure the validity of test results. (|Sec~493.1218)

Documented remedial actions must be taken for tests, equipment, or methods that do not meet specifications; for patient test results that are outside the laboratory's reportable range; or if the reportable range is inappropriate, calibration fails, turnaround times based on urgency are exceeded, or errors are detected in reported results. Record retention must follow specified rules. (|Sec~493.1219)

Quality control record retention (493.1221)

Specific requirements for the appropriate specialty and subspecialty (|Secs~493.1223-.1285)

Quality assurance (|Secs~493.1701-.1721)

For laboratories holding certificates for moderate- or high-complexity testing.

Patient test management assessment (|Sec~493.1703)

Quality control assessment (|Sec~493.1705)

Proficiency testing assessment (|Sec~493.1707)

Comparison of test results for multiple instruments, methodologies, or sites must be made twice a year. Additionally, policies must provide for the establishment of the validity of tests not covered by a proficiency testing program. (|Sec~493.1709)

Relationship of patient information to patient test results (|Sec~493.1711)

Personnel assessment (|Sec~493.1713)

Document communication problems between an authorized person and the laboratory (|Sec~493.1715)

Investigating, correcting, and documenting complaints (|Sec~493.1717)

Quality assurance review with laboratory staff (|Sec~493.1719)

Quality assurance records must be available to Department of Health and Human Services (HHS). (|Sec~493.1721)

Record keeping (found throughout the regulations)

Must include the requirement to keep all records readily accessible for at least two years; those for immunohematology and blood banking for five years; and those for pathology for 10 years. (|Secs~493.1107 and .1109(h)) The records must include instrument printouts and test requisitions unless all the information is stored in a computer file.

Proficiency testing (|Secs~493.801-.959)

The policy should provide a plan of action for handling a PT failure. The policy should stipulate that tests be done with the usual method by personnel who are authorized to perform the test and who routinely do so on an instrument used for routine testing of patient specimens. In other words, you are expected to use the method that is primarily used at your laboratory. The policy should instruct the testing personnel and director to sign the attestation statement affirming that the above requirements have been followed.

Inspection readiness (|Secs~493.1775-.1780)

Except for POLs, which will receive warning, labs will be inspected unannounced. Always be prepared for such an inspection. Maintain a regularly monitored checklist reviewing your readiness to be inspected. Surveyors will focus on interviews showing that tests are being performed only by authorized, qualified personnel. The laboratory director's responsibilities will be minutely examined; keep a diary of your activities relating to laboratory quality and personnel training.

One effective way to create documentation is to take results from a patient's chart and trace the activities from the generation of the test requisition through the assay to the final report. The audit should show that authorized personnel did the test according to policy, using approved and appropriate instruments and procedures. Further, it should show that procedures for QC, calibration, calibration verification, and instrument maintenance were followed and appropriate, and that the specimen was handled correctly. The audit should be able to verify that the test was reported within the laboratory's stated turnaround time in a confidential manner to the authorized person who ordered the test results or will use them.
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Title Annotation:Clinical Laboratory Improvement Ammendments of 1988
Author:Passey, Richard B.
Publication:Medical Laboratory Observer
Date:Nov 1, 1992
Previous Article:Is directed blood transfusion a good idea?
Next Article:Prevention of device-mediated bloodborne infections.

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