This step by step guide will help explain the accreditation process. The PCAB standards are simply a set of compounding quality and safety best practices, and the survey process is designed to help you identify gaps in compliance with these best practices.
Step 1: Gather information. Accreditation is a team effort that will require a commitment of time, and organizational resources. Start by downloading and reviewing the PCAB standards.
In addition to the above, you can also review the pharmacy FAQs and resource documents for even more detailed information.
Step 2: Preparation. This step requires the most time, effort and organizational resources. To use preparation resources effectively, you must identify the areas that need attention and then develop a plan of action for correcting any deficiencies.
Review compliance with the standards. If your pharmacy is not fully compliant with a standard, take the steps necessary to comply. These may be as simple as creating a refrigerator temperature log or as complex as creating and implementing a system to document compounding activities appropriately.
Some PCAB standards require written SOPs. Verify that the pharmacy has the required SOPs, and that the written documents are reflective of what your pharmacy does in practice. For example, if SOPs are purchased from an outside vendor, downloaded, or obtained through other outside sources, verify that the written documents are consistent with the pharmacy’s actual compounding practices.
PCAB requires that your pharmacy have a quality improvement process in place. Because the PCAB standards relate to the quality of compounding, if documented properly using a quality improvement methodology, correcting the deficiencies will meet the requirements for a quality improvement program.
Step 3: Apply for accreditation. Once your pharmacy is fully compliant with the standards, apply for accreditation. PCAB accreditation requires an initial application fee and an annual fee based upon prescription volume. Review PCAB fees here.
The online application is designed to collect demographic and operational information about your pharmacy. You will be asked for the license numbers in each state the pharmacy is licensed, so it will be useful to have this information available when applying.
Please update any changes in the facility contact information, address, staffing, licensure or compounded volume as changes occur. This ensures that PCAB has up to date demographics and contact information.
The annual fee is not due until your pharmacy indicates it is ready to schedule its on-site survey. Once you create your online PCAB account and pay the initial application fee, you can complete your application over time. The final step in completing the application is paying the first year’s annual fee, which informs PCAB your pharmacy is ready for survey.
Step 4: Schedule your survey. Once your application is complete, PCAB will contact you to confirm your readiness for survey. Depending on your volume, your survey will consist of a one or two day visit. A surveyor will be assigned to your pharmacy, and he/she will contact you to set an actual survey date. Surveys are scheduled at your pharmacy’s convenience; they can occur in as little as 3-6 weeks from the date you notify PCAB your application is complete. Initial surveys must occur within 90 days of the date your application is completed.
Step 5: Dry run. Do a preparatory “dry run” for the survey. By the time the survey is scheduled, your organization should have addressed most (if not all) of the major preparation issues. It is then time to prepare your staff by conducting a mock survey. For example, do question-and-answer sessions that are based on the specific standards. The PCAB survey will consist of three major activities: review of facilities, staff interviews & observation, and documentation review. Observe the compounding techniques of your staff and ask them to explain what they are doing.
Step 6: Survey. During the onsite survey, the surveyor will evaluate your compliance with PCAB standards by observing compounding activities, interviewing staff, reviewing documentation and touring your facility. The PCAB surveyor does not make accreditation decisions at this time. Their role is to gather data regarding compliance with PCAB standards and present a report to the PCAB central office.
Step 7: Survey report. Within 30 days of your onsite survey, your pharmacy will receive a written survey report detailing the surveyor’s findings at your pharmacy. This report will identify any compliance deficiencies noted by the surveyor, corrective actions your pharmacy needs to take to become fully compliant with PCAB standards and a time frame in which to accomplish them.
Step 8: Pharmacy response. In some cases, pharmacies will have corrective actions they need to implement before becoming PCAB accredited. At this time, your pharmacy will submit documentation to PCAB that it has addressed these outstanding items. The specific documents will be outlined in the survey report.
In certain situations where a pharmacy is found to have serious non-compliance with PCAB standards, PCAB may require the pharmacy to undergo a second survey to verify the effectiveness of corrective actions.
Step 9: Accreditation decision. Once the pharmacy has submitted its corrective actions, the PCAB accreditation committee will make a decision within 3-4 weeks. Pharmacies are accredited for 3 years, and are expected to maintain compliance with the PCAB standards throughout the entire accreditation cycle.
