Pharmacy Compliance Audits
Cleanroom Compliance Audits
Clearly, it takes a lot to properly run a cleanroom. There’s a significant front end investment and high operating costs. Unfortunately, we have seen, through the hundreds of hospitals we have visited, significant procedural gaps relative to the appropriate aseptic operation of these facilities.
Primarily, it is for this reason that we typically advocate for the use of isolators as they provide a more aseptic, less expensive and more efficient solution. We have had customers with existing compliant clean room facilities purchase our equipment to go outside of the cleanroom, or on the dirty side of their gowning room to decrease cost and increase efficiency.
We have completed hundreds of USP 797 compliant installations throughout the United States. A significant portion of our business over the last few years has been repeat orders from clients expanding existing facilities.
Converting a clean-room to make it USP797 Compliant
If you have an existing facility that requires updating to become compliant, we can handle that type of project as well. On the drawing to the left is a pharmacy that had its primary engineering controls in a non-compliant clean room. The two hoods to the left were sterile hoods and the one hood to the right was a Chemo.
For a very reasonable fee, and in a matter of a few weeks, we can come to your facility for an engineering controls evaluation and provide a conceptual design. The conceptual design shown to the right was part of our “turn-over” package we submitted prior to getting the order to actually implement and construct the design.
In this Pharmacy Compliance Audit, we segmented the existing clean area into three rooms. A large ISO-class VII anteroom (has to be ISO-class VII because it is connected to a negative pressure buffer room), separated into a dirty and clean area. We created a gowning area in the anteroom adding a sterile air shower and low wall return. We sealed off the Chemo hood making a negative pressure USP 800 grade secondary engineering control and added additional air supply and low wall return to meet the ISO-class VII requirement.
We would recommend the addition of a surveillance system with mobile monitoring capability so that aseptic technique can be evaluated.
Our conceptual design recommendation to make this facility compliant and as aseptic as possible was to first eliminate the open hood from the room and to move the isolator into a buffer zone. The few simple changes we made turned this zone into a compliant facility. Also, though not a clean room per se, we lined it out as we normally would a typical sterile facility.
Notice the location of the sink on the dirty side of the anti-area. We firmly believe that if a sink must be placed in a clean room, that it should be on the dirty side of the anteroom as the sink is the major source of microbial contamination in a clean room.
We do a number of Pharmacy Compliance Audits and evaluations and resulting conceptual designs. Typically, we will start with an as found model.
Many modules and custom designs available.
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Pharmacy Compliance Audit – FAQs
1. What is a pharmacy compliance audit?
A pharmacy compliance audit is a systematic review of a pharmacy's operations, documentation, and practices to ensure they meet federal, state, and payer regulations.
2. Who conducts pharmacy compliance audits?
Audits can be conducted by regulatory agencies (e.g., DEA, State Boards of Pharmacy), third-party payers (e.g., PBMs), or internal compliance departments.
3. What are auditors looking for in a pharmacy compliance audit?
Auditors typically examine prescription accuracy, inventory controls, billing practices, recordkeeping, patient privacy compliance, and licensing adherence.
4. What records should be available during a compliance audit?
Prescription logs, DEA forms, inventory records, counseling documentation, claims records, and licenses should be readily available.
5. How often are pharmacies audited?
Audits can be random, scheduled, or triggered by complaints or irregularities. Frequency varies by agency or payer.
6. What are common pharmacy audit findings or issues?
Common issues include improper documentation, billing errors, missing prescriber authorizations, inventory mismatches, and HIPAA violations.
7. What are the consequences of failing a pharmacy compliance audit?
Consequences may include fines, license suspension, loss of contracts, or legal action for serious violations.
8. How can a pharmacy prepare for a compliance audit?
Conduct regular internal reviews, train staff, maintain accurate records, use tracking software, and follow SOPs for compliance.
