CHAPTER 12

QUALITY ASSURANCE FOR MODERATE COMPLEXITY (INCLUDING THE SUBCATEGORY) OR HIGH COMPLEXITY TESTING, ANY COMBINATION OF THESE TESTS

12-1. Condition: Quality Assurance; moderate complexity (including the subcategory) or high complexity testing, or any combination of these tests (§493.1701)

Each laboratory performing moderate complexity (including the subcategory) or high complexity testing, or any combination of these tests, must establish and follow written policies and procedures for a comprehensive quality improvement program which is designed to monitor and evaluate the ongoing and overall quality of the total testing process (preanalytic, analytic, postanalytic). 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. As necessary, the laboratory must revise policies and procedures based upon the results of those evaluations. The laboratory must meet the standards as they apply to the services offered, complexity of testing performed and test results reported, and the unique practices of each testing entity. All quality assurance activities must be documented.

12-2. Standard: Patient test management assessment (§493.1703)

The laboratory must have an ongoing mechanism for monitoring and evaluating the systems required under Chapter 9, 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 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.).

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

g. Customer satisfaction including facility staff, and beneficiaries.

h. Utilization test management including medical appropriateness of testing and usage of test results.

12-3. Standard: Quality control assessment (§493.1705)

The laboratory must have an ongoing mechanism to evaluate the corrective actions taken under paragraph 10-11. 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.

c. Errors detected in reported results.

12-4. Standard: Proficiency testing assessment (§493.1707)

Under Chapter 6, the corrective actions taken for any unacceptable, unsatisfactory, or unsuccessful proficiency testing result(s) must be evaluated for effectiveness.

12-5. Standard: Comparison of test results (§493.1709)

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 different methodologies, instruments, or testing sites. In addition, if a laboratory performs tests that are not included under Chapter 6, the laboratory must have a system for verifying the accuracy and reliability of its test results at least twice a year.

12-6. Standard: Relationship of patient information to patient test results (§493.1711)

For internal quality improvement, 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.

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

12-7. Standard: Personnel assessment (§493.1713)

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.

12-8. Standard: Communications (§493.1715)

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 taken to resolve the problems and minimize communications breakdowns must be documented.

12-9. Standard: Complaint investigations (§493.1717)

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 are instituted.

12-10. Standard: Quality improvement review with staff (§493.1719)

The laboratory must have a mechanism for documenting and assessing problems identified during quality improvement reviews and discussing them with the staff. The laboratory must take corrective actions that are necessary to prevent recurrences.

12-11. Standard: Quality improvement records (§493.1721)

The laboratory must maintain documentation of all quality improvement activities including problems identified and corrective actions taken. All quality improvement records must be available to TSG or their designee.

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