Home > USP Chapter 797 > Gap Analysis

GAP ANALYSIS

Once you have determined the risk level, the next step is to conduct a "gap analysis" and develop an action plan.

Conducting a Gap Analysis

A gap analysis involves comparing USP <797> requirements against current procedures and facilities in your pharmacy. Differences are referred to as "gaps."

Gaps are most likely to occur in the following areas:

• Healthcare settings
• Risk level criteria
• Environmental quality
• Process and preparation quality
• Sterility and beyond-use dating
• Staff training

Healthcare settings

Anyplace where CSPs are prepared must meet USP <797> requirements. This includes clinics, hospital care units, and main and satellite pharmacies. In addition, everyone who prepares compounds must meet requirements, including physicians, nurses, and pharmacists.

Risk Levels Criteria

The most important factor in determining risk level is sound professional judgment based on knowledge of CSP principles.

Environmental Quality

Air quality and cleanliness affects the likelihood of microbial contamination. Dust, dirt, pollen, skin flakes, lint, and cosmetics can all introduce contamination. Depending on your workload and risk levels, you can use cleanrooms, anterooms, laminar airflow workbenches, and barrier-isolators to improve cleanliness levels. Other possible improvements may include

• Installing HEPA filters in the ceiling fans
• Replacing ceiling tiles with "cleanroom grade" tiles
• Removing refrigerators, computers, and printers from the compounding area
• Replacing flooring with seamless vinyl floor covering

Process and Preparation Quality

Compounders and the processes they follow can affect the final quality of CSPs. In addition to maintaining cleanliness, compounding personnel must complete the following steps for each CSP:

• Identify
• Measure
• Dilute
• Mix
• Purify
• Sterilize
• Package
• Seal
• Label
• Store
• Dispense
• Distribute

Sterility and Beyond-Use Dating

When CSPs are prepared in advance and stored for long periods of time, contamination can occur. You need to know the chemical stability of the solution and the acceptable level of pyrogens. You can consult textbooks to find this information.

Staff Training

Many pharmacists and technicians have little to no training in sterile compounding. Before doing any compounding, you should receive training on the theory and practice of sterile preparations. In addition, you should also undergo annual (for low- or medium-risk levels) or semi-annual (for high-risk levels) evaluations.

Developing an Action Plan

Once you have identified gaps, you then

• Analyze the gaps to determine which practices are causing the greatest risk
• Prioritize the gaps according to their cost and impact on CSP quality
• Develop an action plan to identify options for improving CSP practices and reducing microbial contamination

Implementing an action plan based on a risk level assessment and gap analysis demonstrates to accreditation organizations, boards of pharmacy, and other regulatory authorities that you understand USP <797> requirements and are committed to improved practices. The action plan should include both immediate and long-term improvements. Immediate improvements should address non-facility, low-cost practices identified during the gap analysis. Examples include the following:

• Handwashing
• Gloving and gowning
• Staff training
• Aseptic technique media fill validation
• Proper housekeeping (cleaning and sanitizing)
• Microbial environmental monitoring

Long-term improvements may require more time and planning to secure approval, especially if they require large capital expenditures.

Other areas to consider when developing an action plan include whether

• Gaps can be reduced by using alternative products, such as ready-to-use premixed medications
• Compounding can be consolidated at main pharmacies versus satellite pharmacies