At Avella, the safety of patients is always a top priority. Our dedicated pharmacists and support staff are all trained to maintain the strictest compliance with our established quality assurance measures.
Avella's premier service, patient support and commitment to offering quality pharmaceutical products are all reasons that medical professionals seek out our services.
The following FAQs will help answer any questions you may have about our quality assurance processes. Avella also has a formal complaint and investigation process. If you are not satisfied with Avella service or your medication order, please inform your pharmacist. The Avella pharmacist will submit a complaint that will be fully investigated by our Quality Assurance team, and you will be kept informed of the resolution.
A: Yes. One of our pharmacy locations in Arizona was actually one of the very first pharmacies in the nation to achieve PCAB-accreditation. PCAB accreditation means the pharmacy has independent, external validation that it meets nationally accepted quality assurance, quality control, and quality improvement standards.
PCAB's national standards are based on the consensus of industry experts around elements that contribute to the highest quality standards. While all pharmacies must be licensed, PCAB accredited pharmacies have gone the "extra mile" to assure quality.
In order to demonstrate compliance with PCAB standards and earn PCAB accreditation, pharmacies voluntarily participate in an off-site and on-site evaluation process that includes:
- Verification by PCAB that the pharmacy is not on probation for issues related to compounding quality, public safety or controlled substances.
- Verification that the pharmacy is properly licensed in each state it does business in.
- An extensive on-site evaluation by a PCAB surveyor, all of whom are compounding pharmacists trained in evaluating compliance with PCAB's quality standards. For example, this evaluation includes:
- An assessment of the pharmacy's system for assuring and maintaining staff competency.
- A review of facilities and equipment.
- Review of records and procedures required to prepare quality-compounded medications.
- Verification that the pharmacy uses ingredients from FDA registered and or licensed sources.
- Review of the pharmacy's program for testing compounded preparations.
A: Yes. We exceed USP <797> standards, including the following documented procedures:
- Initial training of compounding staff, all of which are certified pharmacy technicians or pharmacists
- Ongoing training of compounding staff
- Regular tests for compounding staff on knowledge of procedures
- Visual observation of compounding techniques
- High Risk Media Fill Kits done during training and then every 6 months thereafter
- Post Hand Hygiene Fingertip Sampling done during training and then every 6 months thereafter
- Post Media Fill Kit (end of shift) Fingertip Sampling done during training and then every 6 months thereafter
- Surface sampling of compounding environment in quadrants done by pharmacy staff every 2 weeks using both bacterial and fungal media
- Cleaning agents used are alternating Clorox 0.5% and Isopropyl alcohol 70% per USP recommendations in order to kill bacteria, fungus, and spores
- Viable air sampling done biannually by a qualified operator
- Smoke, leak, and ISO classification 5 checked on all the laminar flow hoods biannually by a qualified operator
- Surface sampling and air quality for compounding area, ante room, and clean room checked biannually by a qualified operator
- Quality-related event reporting system in place with corrective action plans to improve quality
- Recalls are coordinated and documented by the Quality Assurance Department
- Policy and Procedures written on all USP <797> criteria
A: Avella goes above and beyond the traditional safety precautions and implements additional procedures including, but not limited to:
- Safety Administrator and Safety Officers on staff to provide guidance on safely handling and disposing of hazardous substances
- A formal Customer Complaint Management system including formal investigation of all complaints, root cause analysis, corrective and preventative actions, and information trending.
- An adverse Drug Event Reporting System which includes QA oversight and Clinical Affairs evaluation
- A Corrective and Preventive Action Program (CAPA) which is incorporated into all our quality programs, including root cause analysis, documented CAPA plans, and periodic review of actions taken to ensure they are working
- Annual Review of Established Standard Operating Procedures
- Preventive maintenance procedures for equipment (includes equipment calibration)
- A Quarantine System for Non-Conforming Products or Materials with documented disposition
- A Formal Drug Recall Program and System
- Quality Program Reviews with executive management team and Corporate Compliance Committee
- Certificates of Analysis obtained on every chemical, reviewed by trained staff, and kept electronically and in hard copy in the pharmacy