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How to follow the rules for patient test management.

A process that laboratorians have come to take for granted must now be formalized to prove compliance with CLIA '88.

THE RULES implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) require each laboratory to establish comprehensive and efficient procedures for patient specimen testing from A to Z--that is, from test request through result reporting. These rules are included under the sections related to patient test management (|Secs~493.1101-.1111, pp. 7162-7163) of the Feb. 28, 1992, Federal Register. In these sections the Health Care Financing Administration (HCFA) presents in detail the rules for the preanalytical through post-analytical phases of testing.

(a) The laboratory must have available and follow written policies and procedures for each of the following, if applicable: Methods used for the preparation of the patient; specimen collection; specimen labeling; specimen preservation; and conditions for specimen transportation. Such policies and procedures must assure positive identification and optimum integrity of the patient specimens from the time the specimen(s) are collected until testing has been completed and the results reported.

--Standard; Procedures for specimen submission and handling, |Sec~493.1103, p. 7162

* Special problems. The rules state that only a person authorized by state law may order or receive laboratory information (|Sec~493.1101). The laboratory must guarantee the confidentiality of all reports. The test request must be made in writing or, if oral, documented within 30 days. This requirement will be difficult to fulfill for laboratories in states lacking laws that authorize specific persons to order laboratory tests or receive their results. By custom or medical need, many laboratories receive requests for tests from various medical professionals, including nurses, dietitians, and clerical personnel, as well as from patients.

To accommodate both CLIA and your laboratory practice, you may be required to write policies explaining exactly how you will handle these problems. For example, at certain times laboratory results should be given to clerical personnel or directly to patients. Without clear policies, you will be limited to receiving test requests from physicians and giving results in a confidential manner only to the physician who placed the order. Your reporting system must protect the confidentiality of all results.

The requirement for written requests will be difficult if you ordinarily receive oral requests from a large number of physicians and other health professionals. The written documentation must be traceable to the oral request--a problem that may be insurmountable for a large laboratory. Many laboratories will stop accepting verbal orders, including changes to existing orders unless written at the time of receipt.

* Test requisitions. The test requisition form (|Sec~493.1105) must include the patient's name or unique identifier; the name and address or identifier of the physician or other authorized person requesting the test; and, if appropriate, the individual responsible for utilizing the test result. The test name and date of specimen collection must be listed. All information relevant and necessary to assure accurate and timely testing and reporting of results must be included on the request.

In the past, some low-volume laboratories have not clearly and completely identified each specimen. Now all specimens must be accompanied by positive identification. You must be able to clearly demonstrate the link between the laboratory result and the patient from whom the specimen was taken. The link must include identification of the testing personnel who completed and verified the test result.

Design your test requisition form to include each item required by CLIA '88. Help authorized persons to order tests by their proper names so that you won't have to explain to HCFA surveyors why a free T4 was done when a thyroid was ordered. The concern is that a by-the-book auditor could see a test ordered under one name and billed under another, thus raising the possibility of laboratory impropriety. The not-uncommon practice of changing orders to comply with laboratory practice should be stopped. For example, an authorized person might order a test profile with the code CHEM20 although the laboratory reduced the number of tests in the profile a year ago and renamed it CHEM18. Instead of providing a profile different from the one ordered, the laboratory should ask the originator to reorder it under the current name.

It has been the habit of many laboratories to discard test requisitions after a specified period of time, such as 30 days, because of storage limitations. Yet CLIA '88 requires all information on test requests to be readily available for two years in most sections of the laboratory, for five years in immunohematology, and for 10 years in pathology. Formulate a policy that states how your laboratory handles test requisition storage, what changes may be made to ordered tests, and how oral test orders and changes are documented.

HCFA's instructions and guidelines for surveyors (inspectors) are published in the State Operations Manual. The following excerpts from the State Operations Manual for CLIA '67 (HCFA Pub. 7, March 1991) show how inspectors interpret the requirements for documenting test requisitions under the old rules. At press time, the new version, which will guide surveyors for CLIA '88, had not yet been issued in final form. Although the numbering system has been changed for CLIA '88, the essential requirements will no doubt be the same. The manual also includes probes that the inspector may use to determine the extent of your laboratory's compliance. These same probes and guidelines will surely appear in the new guidelines for surveyors, since reading an advance copy of the new rules suggests that they will be very much like the old ones.

How does the laboratory maintain records documenting oral requests for testing?

How is the authorized person who verbally orders tests notified of the requirement for providing the laboratory with a request?

How does the laboratory attempt to obtain written requests within 30 days?

--Probes, |Sec~493.1105

If any specimen information items are missing from the test requisition, it is up to the laboratory to determine whether to test the specimen; however, the information must be obtained prior to reporting, if the information is essential to the provision of accurate results. Laboratories may choose to report results and indicate on the test report any limitations of test results due to the omission of patient information.

--Guidelines, |Sec~493.1105

If an automated test requisition system is used, how is the laboratory notified when Stat tests are subsequently electronically requested after initial test requests are received?

--Probes, |Sec~493.1105

If the requisition has designated areas for obtaining this information and provides instructions to its clients specifying that these items must be completed, the laboratory has demonstrated compliance with the requirements.

--Guidelines, |Sec~493.1105(f)

Does the laboratory have an accessioning system which positively identifies each patient's specimen and report?

How does the unique identifier used by the system follow patient's specimens from accessioning and specimen handling through reporting of test results?

--Probes, |Sec~493.1107(a)

* Prep, transport, storage. Your patient test management policies must document how you prepare patients and label, transport, and store specimens. You may give patients oral instructions to supplement written information about how they are to get ready for tests requiring self-preparation. The goals are to insure that specimens are adequate for testing and that appropriate specimens are tested.

The requisition may take electronic or written form. The patient's chart may be used as the record of the test requisition and final report. The chart must provide a complete record; you will be required to explain any deficiencies.

The rules for CLIA '67 required the laboratory to document each step in every procedure for all specimens. Mercifully, this has been removed from the revised rules. Nevertheless, the laboratory "must document the handling, preparation, processing, examination and each step in the testing and reporting of results for all proficiency testing samples," according to |Sec~493.801 (b)(5). This documentation can be achieved with a statement on a PT summary report documenting who did the specimen preparation, testing, and reporting, including the instrument and method used along with notes concerning the challenge.

* Completeness. Your record of each test must include the patient's name or other suitable identifier, the time and date of specimen receipt, and the date of testing. Records must show the condition and disposition of specimens found to be unacceptable because they were grossly hemolyzed, used the wrong anticoagulant, or for other reasons. Specimen testing records must show who did the test and indicate that the specimen was properly identified.

If you have instrument printouts and all information contained on the printout is not automatically transferred to a computer, the standard record keeping requirements demand that you retain the instrument printouts for two years (in immunohematology, for five years). The justification is to verify that the laboratory is not changing the reported results. Using instruments attached to computers will probably benefit laboratories that produce a tremendous volume of records. Just make sure that all information generated on the printout, including error codes and dilution factors, is transferred to the laboratory information system (LIS).

* Accurate and timely. Test reports must be sent promptly to authorized person(s) in a timely, accurate, and confidential manner. Confidentiality may be difficult to sustain, especially in an open computer terminal on which anyone can look up results. The rules require that you make the information available to the authorized person or the person designated to use the results. Well-written policies help establish who may view a report. The proficiency testing rules mandate that the test report include the name and address of the lab where the test was performed. Further, a list of test methods and performance specifications must be made available on request by the authorized individual who ordered the test or by the person designated to use the results.

Any unusual specimen conditions must be reported with the test result. If the specimen was unsuitable, the disposition of the specimen must be documented. Also required are pertinent reference ranges. Since providing all this information may be extremely difficult for small laboratories, the rules allow use of data supplied by test kit manufacturers for reference ranges. In the absence of manufacturer's data, you will have to show that your values agree with references from the literature. Keep a list of several patients who should have normal results; producing these data will help you demonstrate that your reference ranges are appropriate. Your test reporting procedures must also state the reporting method for values that are apparently life-threatening (critical limits).

* Referring specimens. All outside laboratories to which your lab refers patient specimens must hold a valid certificate; otherwise your lab will be held to be in violation of CLIA '88. You must not change any results or interpretation of results provided by the referral laboratory. Referral laboratories may, according to the rules, mail the results directly to the authorized person who ordered the test. The referral laboratory must keep an exact duplicate of the test results. No matter who receives the results, the authorized person must be notified of the name and address of the referral laboratory where the test was done.

* New awareness. Patient test management, a process we have come to take for granted, must now be formalized to prove compliance with the extensive regulations of CLIA '88. The result will be a cleaner flow of information, in many cases better specimens for testing, and more accurate and timely test reports. Patients will benefit from these improvements even though overall testing costs will increase.

Richard B. Passey is professor of pathology, University of Oklahoma Health Sciences Center, and director of clinical chemistry, Oklahoma Medical Center, Oklahoma City. Chairholder of the committee that formulated EP6-P 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; Clinical Laboratory Improvement Amendments
Author:Passey, Richard B.
Publication:Medical Laboratory Observer
Date:Jan 1, 1993
Previous Article:Creating a newsletter for the laboratory.
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