Establishing a quality unit

A formal quality unit not only helps assess overall performance but also provides continuous improvement to patient care

By Fran McAteer, Microbiology Research Associates

One of the preliminary actions for USP <797> compliance is the establishment of a formal quality unit for the pharmacy, which is responsible for the quality assurance program (QA) and provides the means for implementing, monitoring, evaluating, correcting, improving, and maintaining USP  <797> activities. The quality unit must be independent and have strong senior management support. It should also reflect the size and activity of the pharmacy. For example, in a large pharmacy with multiple shifts, the unit may be multi-tiered and consist of representatives from each shift, while in a smaller hospital, the unit may be only one person. The quality unit will be responsible for USP <797> compliance and administration of the QA program and should establish a formal quality policy that includes a mission statement, specific responsibilities, membership, and senior management support. The specific responsibilities should include:

  1. Formalization in writing. The QA program should have a mission statement that includes a statement of support from senior management and the ability to enforce quality procedures in the pharmacy.
  2. Consideration of all aspects of the preparation and dispensing of product as described in the <797> chapter, including environmental testing and validation results. The QA program should detail all aspects of preparation and dispensing of CSPs in formal standard operating procedures (SOP) that are numbered and revision-controlled. These procedures should include purpose, responsibility, scope and materials, and detailed procedural steps to compound sterile preparations on a consistent basis. The program should also include ancillary testing and support procedures needed for successful preparation of sterile products.
  3. Description of specific monitoring and evaluation activities. The monitoring of evaluation activities provides feedback on quality control to pharmacy management. The monitoring of evaluation activities should be specified by such parameters as frequency, quantities of samples, action and alert levels.
  4. Specification of how results are to be reported and evaluated. These specifications are the acceptance criteria for the overall quality and release of CSPs.
  5. Identification of appropriate follow-up mechanisms when action limits or thresholds are exceeded. The corrective action and prevention plan details “out-of-specification” situations so that a follow-up plan can be developed and measured to ensure continuous improvement.
  6. Delineation of the individuals responsible for each aspect of the QA program. Job descriptions should be developed for QA specialists, detailing their responsibilities and supervision.

The quality unit should meet frequently, if not daily, to coordinate USP <797> activities, and the unit should provide staff leadership in the implementation of USP <797> requirements through education, training, and proficiency testing. Education and training should be accompanied with objectives, self assessment questionnaires, and training documentation. The unit should also establish specific <797> objectives and develop a quality monitoring plan for measurable parameters. QA practices should be incorporated into the daily schedule of the pharmacy and be ingrained into routine compounding procedures. These QA practices should include:

  • Routine inspection of cleanliness of compounding area. The QA program should include, as part of its QA practices, a high level of cleanliness, which should be the norm for the appearance of the compounding areas. This area should be free of clutter.
  • Proper hand-washing, disinfection and gowning techniques. It is of utmost importance that pharmacists utilize proper hand-washing techniques including the use of disinfectant soaps, and scrubbing techniques with a final disinfection of 70 percent isopropyl alcohol (e.g., Purell or similar material). Gowning techniques and apparel should be incorporated into the training of compounding professionals. Technicians should also be required to demonstrate proficiency in these procedures before gaining access to the compounding area.
  • Assurance of documentation, orders, ingredients, quantities, lot numbers and package integrity. This QA practice is important for verification of the accuracy of the CSP. Any deviation in documentation, ingredients, quantities, lot numbers and integrity should be brought to the attention of the supervisor before continuing compounding operations.
  • Visual inspection of CSP. The final QA practice provides a last level of quality through visual inspection of the CSP. The technician can assess particulate level, color, clarity and uniformity of the solution. Great care should be taken to ensure container closure integrity is maintained.

Monitoring activities should be increasingly meticulous according to the risk assessment of the CSPs being processed. For example, procedures that are at a high risk for contamination require more monitoring for air, surfaces and personnel. QA practices should incorporate trending of monitoring data and validation to evaluate overall aseptic performance. This will better establish applicable action/alert levels to minimize CSP contamination. The program should also include corrective action plans and prevention plans to ensure effective results. The corrective action plan should document “out-of-specification” results, investigate methodology for compliance and, if applicable, outline procedures for continuous improvement.

The combination of a corrective action program, environmental monitoring, trend analysis, standard operating procedures and follow-up mechanics not only supplies QA with the ability to better assess overall quality performance in the pharmacy but also provides continuous improvement to patient care for the hospital. The initiation of a quality assurance program should be paramount in the project plan and will provide the foundation on which to build strong USP <797> compliance.

Fran McAteer is vice president of quality at Microbiology Research Associates, Inc. (Acton, MA), an FDA-registered contract microbiology testing laboratory specializing in USP testing for pharmaceuticals, biologics and medical devices. He has expertise and experience in implementation of <797> programs for hospital pharmacies and acts as a consultant for many hospitals. He can be reached at (978) 263-2624.


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