Accreditation Process

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.  An initial PCAB application requires a registration fee and an initial accreditation fee, based upon prescription volume.  Accreditation fees are billed annually starting with your second year of accreditation. 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.

Once you create your online PCAB account and pay the registration fee, you can complete your application over time.  Your initial accreditation fee is due upon submission of your application. .

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.  Initial surveys are announced and scheduled in consultation with the pharmacy.  Initial surveys must occur within 6 months of the application submission date.

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.

Step 8: Pharmacy response.  In some cases, pharmacies will have corrective actions they need to implement before becoming PCAB accredited.  You will be asked to complete a Plan of Corrective Action (PCA) that will address all deficiencies noted on your survey report to allow the pharmacy to become fully compliant with PCAB standards.  PCAB will provide the Plan of Corrective Action form and instructions on completing the form.  Your pharmacy will submit its completed PCA and any support documentation to PCAB for review and approval.

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’s corrective actions have been accepted by PCAB internal reviewers, the PCAB Accreditation Committee will review the final Plan of Corrective Action documentation to make a decision on accreditation status.  Pharmacies are accredited for 3 years, and are expected to maintain compliance with the PCAB standards throughout the entire accreditation cycle.