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A provider of CSPs must have in place a formal Quality Assurance (QA) Program4 intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter. Emphasis in the QA Program is placed on maintaining and improving the quality of systems and the provision of patient care. In addition, the QA program ensures that any plan aimed at correcting identified problems also includes appropriate follow-up to make certain that effective corrective actions were performed.5
Characteristics of a QA plan include the following:
  1. Formalization in writing;
  2. Consideration of all aspects of the preparation and dispensing of products as described in this chapter, including environmental testing, validation results, etc.;
  3. Description of specific monitoring and evaluation activities;
  4. Specification of how results are to be reported and evaluated;
  5. Identification of appropriate follow-up mechanisms when action limits or thresholds are exceeded; and
  6. Delineation of the individuals responsible for each aspect of the QA program.
In developing a specific plan, focus is on establishing objective, measurable indicators for monitoring activities and processes that are deemed high-risk, high-volume, or problem-prone. Appropriate evaluation of environmental monitoring might include, for example, the trending of an indicator such as settling plate counts. In general, the selection of indicators and the effectiveness of the overall QA plan is reassessed on an annual basis.