Tenn. Comp. R. & Regs. 1200-06-03-.10 - PERFORMANCE IMPROVEMENT PROGRAM

(1) Condition: Performance improvement. Each laboratory 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. The laboratory's performance improvement 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.

(a) The laboratory must revise policies and procedures as necessary based upon the results of those evaluations.

(b) The laboratory must meet the standards of this rule as they apply to the services offered, tests performed, test results reported, and the unique practices of each testing entity. All performance improvement activities must be documented.

(2) Standard: Patient test management assessment. The laboratory must have an ongoing mechanism for monitoring and evaluating the systems required under Rule 1200-06-03-.08, Patient Test Management. The laboratory must monitor, evaluate, and revise, if necessary, based on the results of its evaluations, the following:

(a) The criteria established for patient preparation, specimen collection, labeling, preservation and transportation;

(b) The information solicited and obtained on the laboratory's test requisition for its completeness, relevance, and necessity for testing of patient specimens;

(c) The use and appropriateness of the criteria established for specimen rejection;

(d) The completeness, usefulness, and accuracy of the test report information necessary for the interpretation or utilization of test results;

(e) The timely reporting of test results based on testing priorities (STAT, routine, etc.); and

(f) The accuracy and reliability of test reporting systems, appropriate storage of records and retrieval of test results.

(3) Standard: Quality control assessment. The laboratory must have an ongoing mechanism to evaluate the corrective actions taken under paragraph 1200-06-03-.09(9), Remedial Actions.

Ineffective policies and procedures must be revised based on the outcome of the evaluation. The mechanism must evaluate the effectiveness of corrective actions taken for the following:

(a) Problem identified during the evaluation of calibration and control data for each test, method;

(b) Problems identified during the evaluation of patient test values for the purpose of verifying the reference range of test method; and

(c) Errors detected in reported results.

(4) Standard: Quality control assessment. Under Rule 1200-06-03-.07, Participation in Proficiency Testing, the corrective actions taken for any unsatisfactory or unsuccessful proficient testing result(s) must be evaluated for effectiveness.

(5) Standard: Comparison of test results. If a laboratory performs the same test using different methodologists or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using different methodologies, instruments, or testing sites. If a laboratory performs tests that are not included under 42 CFR §493.901 of CLIA, Proficiency Testing Programs, the laboratory must have a system for verifying the accuracy and reliability of its test results are least twice a year.

(6) Standard: Relationship of patient information to patients test results. The laboratory must have a mechanism to identify and evaluate patient test results that appear inconsistent with relevant criteria such as:

(a) Patient age;

(b) Sex;

(c) Diagnosis or pertinent clinical data, when provided;

(d) Distribution of patient test results when available; and

(e) Relationship with other test parameters, when available within the laboratory.

(7) Standard: Personnel assessment. The laboratory must have an ongoing mechanism to evaluate the competency of all laboratory personnel

(8) Standard: Communications.

(a) The laboratory must have a system in place to document problems that occur as a result of breakdowns in communication between the laboratory and the authorized individual who orders or receives the results of test procedures or examinations.

(b) Corrective actions taken to resolve the problems and to minimize communications breakdowns must be documented.

(9) Standard: Complaint investigations. The laboratory must have a system in place to assure that all complaints and problems reported to the laboratory are documented. Investigations of complaints must be made, when appropriate, and, as necessary, corrective actions must be instituted.

(10) Standard: Performance improvement review with staff. The laboratory must have a mechanism for documenting and assisting problems identified during performance improvement reviews and discussing them with the staff. The laboratory must take corrective actions that are necessary to prevent recurrence.

(11) Standard: Performance improvement records. The laboratory must maintain documentation of all performance improvement activities including problems identified and corrective actions taken. All performance improvement records must be maintained for period of two (2) years and available to the Board or its designee upon request.

Notes

Tenn. Comp. R. & Regs. 1200-06-03-.10

Original rule filed October 26, 1979; effective December 10, 1979. Repeal filed May 3, 1995; effective July 17, 1995. New rule filed January 7, 1997; effective March 23, 1997. Repeal and new rule filed June 18, 2002; effective September 1, 2002.

Authority: T.C.A. §§ 4-5-202, 4-5-204, and 68-29-105.