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CLIA's quality assurance: a study in total devotion.

Under Federally mandated QA, complaints and problems become treasure maps that may lead to the source of errors and, ultimately, to the attainment of quality.

TOTAL DEVOTION to the pursuit of quality by all employees is what Health Care Financing Administration (HCFA) surveyors (inspectors) will look for when they come knocking at your lab door. Your lab's director and technical supervisor are vital to the successful application of HCFA's idea of what constitutes good quality assurance (QA) because they are the ones who must establish and enforce the policies that bring quality to the laboratory.

Here's how CLIA states QA requirements|1~:

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 |sic~ is designed to monitor and evaluate the ongoing and overall quality of the total testing process (preanalytic, analytic, postanalytic).

Condition: Quality assurance; moderate or high complexity testing, or both. 493.1701, p. 7183.

Laboratorians (CLIA uses the phrase "testing personnel") must document how they follow laboratory policies throughout the preanalytical, analytical, and postanalytical phases of testing. How you instill in your staff the importance of quality and the documentation thereof is easier if your QA policies are crafted carefully.

* Grouping work. An extreme view of CLIA might make it seem that every act must be documented. A more reasoned approach, however, reveals that CLIA requires documentation of groups of activities. For example, a laboratorian could sign or initial a worksheet to document that he or she:

* Followed the laboratory's policies for processing specimens (and identifying inappropriate ones).

* Followed the established mechanisms for testing and reporting results.

The worksheet should have a short statement affirming that the lab's written policies were followed. The laboratorian's signature serves as verification. You can construct many other appropriately grouped activities and it behooves you to do so. The alternative is to greatly multiply the arduous task of documentation.

Remember that the actual operation of the clinical laboratory--as viewed and verified by HCFA during an inspection--must demonstrate that the policies were followed exactly as written. Make modifications in writing and assure that they are authorized by the laboratory director.

* Seekingy errors. QA is more than documenting that a task was done. It is evaluating each task to see whether it contributes any errors to the process.

The search for errors will be a new way of life under CLIA. In our normal pursuit of perfection, we often avoid admitting mistakes. Under HCFA's quality assurance, however, complaints and problems become treasure maps that may lead to the source of errors. You will want to have your errors documented to demonstrate your approach to problems and your sincerity about assuring quality.

HCFA doesn't want us to have errors or worse, to manufacture them, but the reality is that all laboratories, even excellent ones, are so complex that mistakes occur. Our task is to improve quality by rooting them out.

All employees must be evaluated and trained by the technical supervisor/consultant (a term that, like "consultant," is CLIA-speak for "supervisor") and must be given final authorization by the laboratory director in order to perform each test or task. Every trained and authorized laboratorian must search for problems that, after discovery, must be investigated. Then the laboratory's policies, procedures, and training must be evaluated and changed so that errors are minimized. These changes must then be incorporated into the routine operations of the laboratory.

* Requirements. CLIA's requirements for evaluating quality assurance policies and practices are found in the following sections of the regulations: patient test management (493.1703, p. 7183), quality control (QC) (493.1705, p. 7184), proficiency testing (PT) (493.1707, p. 7184), comparison of test results (493.1709, p. 7184), relationship of test results to patient's condition (493.1711, p. 7184), personnel assessment (493.1713, p. 7184), and complaint evaluation (493.1717, p. 7184). All changes in policies and practices must be communicated to laboratory employees and be documented fully.

Improving the quality of patient testing includes establishing criteria and documentation procedures for specimen collection, labeling, preservation, and transportation. One way to document these processes is by using the phlebotomy list. If all tasks are performed by one person, use one checkoff for documentation; if more than one person is involved, use the appropriate number of checkoffs.

* Test requisition. The information required for test requisition must be evaluated for completeness and appropriateness. Following are the requirements|1~:

The laboratory must assure that the requisition or test authorization includes:

(a) The patient's name or other unique identifier;

(b) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for utilizing the test results or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminent life-threatening laboratory results or panic |critical~ values;

(c) The test(s) to be performed;

(d) The date of specimen collection;

(e) For Pap smears, the patient's last menstrual period, age or date of birth, and indication of whether the patient had a previous abnormal report, treatment or biopsy; and

(f) Any additional information relevant and necessary to a specific test to assure accurate and timely testing and reporting of results.

Standard: Test requisition. 493.1105, p. 7162.

Remember also to set criteria for specimen rejection and for documentation that proves the criteria were followed.

* Turnaround time. Policies for the completeness, usefulness, and accuracy of test reporting must be evaluated by looking at your reporting system. This includes looking at how priority tests are handled.

If you promise 20-minute turnaround times (TATs), you must have data to show that you meet this goal and that exceptions are handled according to your requirements. Remember: Patient test management rules say that if a test is delayed beyond what your policy specifies, you must notify the person who ordered or will use the test results.

You can save yourself a lot of grief by setting and writing realistic TAT and phone notification policies. For example, don't say you will notify the authorized person by phone for every result. Specify that you will notify him or her of specific meaningful results. (Defining what constitutes a meaningful notification value is an interesting exercise, you will find.)

* Whom to call. It is also important to specify in your notification policy the person to whom your lab should report results and notify of delays. You may not want or be able to call a surgeon out of the operating room to say that a normal potassium value will be delayed for another 10 minutes. At the same time it may be critical to notify an emergency room nurse that a glucose on a comatose patient is going to be delayed so that an alternate fingerstick procedure can be performed.

* Keeping records. HCFA requires that most records be stored in a readily accessible form for two years. Blood bank records, however, must be readily accessible for five years, and pathology records for 10 years. The secret is to define carefully which records you will save by first establishing those that will show adequately your quality and the completeness of your testing system.

HCFA says that instrument printouts may be required to show that laboratory results are true and faithful. If your records aren't automatically stored in a computer with all data elements, including positive patient identification and error codes, you may need to keep instrument printouts (for two years).

* Documenting QC. Quality assurance assessment of quality control includes requiring policies for corrective and remedial actions and for the documentation of problems identified through the evaluation of QC data. All unacceptable analyte or proficiency testing (PT) event scores must be followed with remedial action.

In your review of QC data, you must also look for errors in your calibration and calibration verification policies and actions. You must show how you validate patient test results (or how test results are verified), how you establish reference ranges, and how you handle known errors in reporting results. To evaluate your reference ranges, you can compare them periodically with assays of apparently normal patients. The results for normal patients should fall within the appropriate reference range 95% of the time.

* Proficiency testing. The quality assurance of proficiency testing will be a special focus of HCFA inspections. Any failures must have been evaluated for cause. All problems and policy failures must be corrected by changing the appropriate policies and procedures.

The inspectors will expect to find all affected employees trained and practicing the changes made to improve laboratory quality. PT failure can easily lead to losing HCFA authorization to do the test in question. Even if you voluntarily stop doing the test, the process required for reinstatement is difficult. Especially difficult is the required delay of six months or more, during which time you must prove your ability to participate successfully in PT.

If you withdraw voluntarily, or receive sanctions that force you to stop reporting the results of a test, you must then demonstrate sustained satisfactory performance on two consecutive PT events (493.807, p. 7146). This is an extremely serious penalty. It will take you at least six months to pass two consecutive events unless you can convince your PT service to expedite the program, or unless HCFA will allow early on-site proficiency testing by a HCFA-authorized surveyor.

In any case, unless the test can be done by another laboratory quickly and easily, the delays will seriously damage your laboratory's service and reputation. (You may escape some damage if the test was not essential.) Few employers can afford to maintain a laboratory without it generating revenue. So HCFA's policy will no doubt result in a reduction of staff or even the closure of some labs.

* Comparing methods. If your laboratory tests any analyte by more than one method or instrument or at different sites, you must, twice a year, evaluate the relationship of the methods. HCFA does not offer guidance on what comparison is required. My advice is to show that methods correspond within an allowable error that is medically appropriate.

As an alternative, you can use your performance criteria to judge acceptable conformity. Assay five patients' specimens, calculate their means, and set the acceptable range at equal to or less than |+ or -~ the performance specification for imprecision. Your policies should state what you will do if your instruments or methods show performance outside these limits. There could be legitimate reasons for allowing larger differences. For example, a very fast method with short TAT could be implemented even though an interference affects certain specimens that are rarely used.

* Verifying accuracy. Take special note of the requirement for methods that do not have PT evaluation to be verified twice yearly for accuracy and reliability. Use the National Committee for Clinical Laboratory Standard's evaluation protocol EP10-T, Preliminary Evaluation of Clinical Chemistry Methods.|2~ When used with specimens with known values, this protocol will test a method's bias, linearity, and precision using only 55 assays done over five days.

* Correlating tests. One of the most difficult requirements of CLIA is to evaluate patient test results with the findings of other assays and with such patient demographics as sex, diagnosis, and clinical data (if such information is provided).

I suggest that you evaluate a small sample of laboratory-completed reports, including any tests about which complaints have been received. The selected test results should be evaluated against the patients' medical conditions for appropriateness. Your policies should specify the action to take in situations where inappropriate test values are found. Such actions could be changing methods or warning users of interferences or diseases in which the particular test is inappropriate.

* Evaluating personnel. All policies and procedures and any changes to them must be communicated to personnel.

You must also create a system to evaluate the competence of each employee. This can be done by having personnel test a specimen with a value unknown to them, and by setting acceptable criteria for the blind testing. Suitable specimens are patient samples on which the test has been previously performed, excess PT material (after the reporting date), or special control material with known values. Currently used control material is not suitable because the value and the identification (by appearance) is too easily recognized.

Your policies should specify the allowable differences from the known values. Acceptable error could be your medically significant error or |+ or -~ two times the performance specification for imprecision (two standard deviations are acceptable because you are testing only one or two specimens). In your policies, state what action will be taken for values that exceed your criteria. Include the number of permissible repeats and specify what retraining or final action will be taken if the competence exam should be failed.

* Investigating complaints. Any breakdown in communication between the lab and the authorized person who orders or uses results must be documented. This includes complaints, which must be treated as valuable evaluations of laboratory performance.

HCFA looks at complaints and their resolution as windows on the true worth of the laboratory. If the customers are dissatisfied, the usefulness and future of the lab is in question. Excellent laboratories will accept complaints with dignity and evaluate them carefully, hoping that the unasked-for assessment will improve the overall quality of their facilities.

Record complaints in a file or log that contains all important information including the date, the time, the name of the person who made the complaint, and the name of the person who took the complaint. Also note the details of the problem, the proposed solution, and any policy or procedure modifications that resulted. Include also whether these changes were effective in resolving the problem and preventing recurrence.

Be careful how you define a complaint. I suggest that complaints be considered official when they are written. The unsavory alternative is chasing gripes from people who are having bad days.

* Summary report. CLIA's charge to laboratories is to establish a QA program that will monitor and evaluate the ongoing and overall quality of the total testing process.

To help your laboratory prove its dedication to quality, write a summary report that shows how the QA program works and includes the results of the self-evaluation. The report should summarize all QA activities and point to the records that document each one. The report must be kept up to date and signed by the technical supervisor and the laboratory director.

The take-home message is that Federal QA requirements are the means by which your laboratory shows how quality is achieved and maintained. As always, quality is our prime objective.

The series so far

How to obtain a CLIA certificate (August 1992)

How to meet the new personnel requirements (September 1992)

How to read the Federal Register (October 1992)

A master plan for implementing CLIA (November 1992)

How to prepare for a proficiency testing event (December 1992)

How to follow the rules for patient test management (January 1993)

Walking the straight and narrow on quality control (February 1993)

How to prepare for and survive a CLIA inspection (March 1993)

Still to come

* Avoiding penalties

* Method validation


1. Federal Register. February 28, 1992; 57:7001-7288.

2. National Committee for Clinical Laboratory Standards. Preliminary Evaluation of Clinical Chemistry Methods. Tentative Guideline EP10-T. Villanova, Pa: NCCLS; 1989.

The author is professor of pathology, University of Oklahoma Health Sciences Center, and director of clinical chemistry, Oklahoma Medical Center, Oklahoma City. Chairholder of the committees that formulated EP6-P and EP10-T for the National Committee for Clinical Laboratory Standards, he has been presenting CLIA workshops for several years for the NCCLS and the American Association for Clinical Chemistry.
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Title Annotation:Coping With CLIA, part 9; Clinical Laboratories Improvement Amendment of 1988
Author:Passey, Robert B.
Publication:Medical Laboratory Observer
Date:May 1, 1993
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