A rapidly increasing number of laboratories are now establishing molecular technologies to use for clinical diagnosis. Efforts by professional organizations such as ACMG, AACC, ABB, CAP, AMP, CLSI, and government agencies (exemplified in the new CLIA'88 rules) are being directed to the standardization of both the test systems and the laboratory procedure. Quality Assurance guidelines specific for molecular laboratories have not been clearly established yet. What has been presented in this chapter is intended to inform and guide such laboratory as to what to consider in instituting a QA program.

At our hospital, a plan has been in place for monitoring QA indicators for different laboratory sections. The purpose of the plan is to ensure that the department with all its available resources implements the mission of the hospital to provide the service needed to sustain the highest possible standard of patient care. The overall responsibility for the Quality Assessment plan lies with the Chairman of the department who shares reports of QA activity with the QA committees of the hospital. "Key indicators" for each laboratory section are selected at the beginning of each year and monitored monthly. If the indicator selected does not meet the established threshold, it is the responsibility of the director of that laboratory section to formulate an improvement plan and to implement it. The following is an example of one of the indicators (turnaround time) the Diagnostic Molecular Pathology laboratory is monitoring. It is divided into two parts: the first requires the selection of an indicator to be monitored (Table 1) and the second outlines a plan to monitor the indicator selected (Table 2).

Following are suggested key indicators that can be used to assess QA practices in your laboratory. See also the article by McGovern et al. (6) for other laboratory practice standards that can be used as indicators.

Suggested Indicators for the Preanalytical Phase

1. Percentage of specimens received without a requisition

2. Percentage of specimens received with inadequate demographics

3. Percentage of specimens with inadequate amounts of nucleic acid extracted

4. Percentage of specimens received with incorrect preservatives

5. Percentage of improperly stored specimens

6. Percentage of improperly labeled specimens

7. Percentage of rejected specimens (broken down by type)

8. Monitoring of the average time from specimen collection to receipt in laboratory

9. Percentage of clerical errors (broken down by type)

Suggested Indicators for the Analytical Phase

1. Average time from specimen receipt to verification of result

2. Percentage of tests that are repeated (broken down by reason)

3. Percentage of controls that are unacceptable

4. Percentage of contaminated runs

Suggested Indicators for Postanalytical Phase

1. Percentage of final reports that have significant clerical or typographic errors

2. Percentage of molecular diagnostic reports released after stated TAT

3. Percentage of molecular diagnostic reports confirmed as delivered electronically

Suggested Indicators for the Entire Testing Process

1. Percentage of correlations between two different methodologies

2. Percentage of a specific group of surgical pathology cases (hyperplastic lymph nodes, ASCUS, etc.) that were tested by a molecular method

3. Percent correlation of molecular results and surgical pathology findings

4. Percent correlation of retrospectively reviewed molecular diagnostic cases

5. Monitoring of the effect the test results has on patient care (i.e., chart review)

6. Average TAT for molecular diagnostic reports (from time of receipt in the laboratory to the time report is resulted)

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