(1)Each laboratory performing physician performed microscopy, moderate or high complexity testing 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 (pre-analytic, analytic, post-analytic).
(2)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.
(3)The laboratory must meet the requirements of this rule as they apply to the services offered, complexity of testing performed, test results reported, and the unique practices of each testing entity.
(4)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 the 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.
(5)The laboratory must have an ongoing mechanism to evaluate the corrective actions taken under remedial action.
(6)Ineffective policies and procedures must be revised based on the outcome of the evaluation. The mechanism must evaluate and review the effectiveness of corrective actions taken for:
(a)Problems 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 a test method; and
(c)Errors detected in reported results.
(7)The corrective actions taken for any unacceptable, unsatisfactory, or unsuccessful proficiency testing result(s) must be evaluated for effectiveness.
(8)If a laboratory performs the same test using different methodologies or instruments, 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 the different methodologies, instruments, or testing sites.
(9)If a laboratory performs tests that are not included in an approved proficiency testing program, the laboratory must have a system for verifying the accuracy of its test results at least twice a year.
(10)The laboratory must have a mechanism to identify and evaluate patient test results that appear inconsistent with relevant criteria including:
(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.
(11)The laboratory must have an ongoing mechanism to evaluate the effectiveness of its policies and procedures for assuring employee competence and, if applicable, consultant competence:
(a)The assessment of employee competence must be biannually the first year of employment; and
(12)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; Corrective actions must be taken and documented, as necessary, to resolve the problems and minimize communications breakdowns.
(13)The laboratory must have a system in place to assure that all complaints and problems are documented. Investigations of complaints must be made and appropriate corrective actions instituted.
(14)The laboratory must have a mechanism for documenting and assessing problems identified during quality assurance reviews and discussing them with the staff. The laboratory must take corrective actions necessary to prevent recurrences.
(15)The laboratory must maintain documentation of all quality assurance activities including problems identified and corrective actions taken.
(16)All quality assurance records must be available to the Division and maintained for a period of 2 years.
Rule 333-024-0043 — Quality Assurance,