The Joint Commission (TJC) issued a letter in 2018 informing hospitals that due to recurring issues pertaining to the certification process for Pharmacy Sterile Compounding Clean rooms, this will be a focus of 2018-2019 TJC surveys. The Central Division of Atrium Health, with over 1,000 patient beds and 20 pharmacy clean rooms, was surveyed in 2018. We conducted a multidisciplinary review of requirements and roles and responsibilities around clean rooms and will provide you with a roadmap for developing a program for continual certification and share lessons learned from our TJC survey.
Identify the pharmacy sterile compounding clean room environmental certification requirements per USP 797, USP 800, and CAG-003-2006 (Sterile Compounding Facilities).
Develop a roles and responsibility matrix and flow chart.
Define when certification is required, above and beyond every 6 months.
Provide requirements to the agency performing the certifications.
SASHE, CHFM, CHC, CHSP, CHEP,
Director, Central Division Facilities Operations,
Director of Pharmacy Services,