MediTape Compliance

Regulatory Compliance

“With MediTape’s standardized reporting process, fewer quality assurance and patient test management deficiencies are cited by CLIA and COLA inspectors.”
– C. Anne Pontius, President
Laboratory Compliance Consultants, Inc.

The Clinical Laboratory Improvement Amendments of 1988 have specific requirements for the test requisition, test record, and test report. A summary has been provided below. For complete information, log on to the section about Patient Test Management at the web site of the Centers for Disease Control and Prevention.

NOTE: MediTape.com does not claim to be the final word on laboratory compliance with government regulations. That is best left to state and federal inspectors and professional laboratory consultants.

Patient Test Management

for Moderate Complexity (including the Subcategory), High Complexity, or any combination of these tests:

Test Requisition

The laboratory must perform tests only at the written or electronic request of an authorized person. Records of test requisitions or test authorizations must be retained for a minimum of two years. 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

(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.

Test Records

The laboratory must maintain a record system to ensure reliable identification of patient specimens as they are processed and tested to assure that accurate test results are reported. These records must identify the personnel performing the testing procedure. Records of patient testing, including, if applicable, instrument printouts, must be retained for two to five years. The record system must provide documentation of information specified for the Test Requisition or Test Authorization (above) and include —

(a) The patient identification number, accession number, or other unique identification of the specimen;

(b) The date and time of specimen receipt into the laboratory;

(c) The condition and disposition of specimens that do not meet the laboratory’s criteria for specimen acceptability; and

(d) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s).

Test Report

The laboratory report must be sent promptly to the authorized person, the individual responsible for using the test results or laboratory that initially requested the test. The original report or an exact duplicate of each test report, including final and preliminary report, must be retained by the testing laboratory for a period of two to ten years after the date of reporting.

(a) The laboratory must have adequate systems in place to report results in a timely, accurate, reliable and confidential manner and ensure patient confidentiality throughout those parts of the total testing process that are under the laboratory’s control.

(b) The test report must indicate the name and address of the laboratory location at which the test was performed, the test performed, the test result and, if applicable, the units of measurement.

(c) The laboratory must indicate on the test report any information regarding the condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability.

(d) Pertinent “reference” or “normal” ranges, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests or the individual responsible for utilizing the test results.

(e) The results or transcripts of laboratory tests or examinations must be released only to authorized persons or the individual responsible for utilizing the test results.

(f) The laboratory must develop and follow written procedures for reporting imminent life-threatening laboratory results or panic values.

(g) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications of each method used to test patient specimens.

(h) The original report or exact duplicates of test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility.