Facilities and Equipment cover the physical design of the cleanroom where compounding takes place. Elements like sink placement, minimal furniture, airflow, and air filters are all important. Restricted access barrier systems or laminar air flow systems deliver the unidirectional airflow needed to prevent contamination. Environmental Monitoring is required, with viable surface and air testing currently performed every six months at a minimum.
Good record keeping and immediate corrective action when contaminants are detected are essential parts of cleanroom monitoring. Personnel Training and Practices are critical to maintaining a contaminant-free work area. Requalification and remedial training are covered too. Policies and procedures must address personal hygiene, proper clothing and protective gear, cleaning and disinfection.
Certification, accreditation and communications experts within The Joint Commission share experiences, case studies and news that add insight and value to the accreditation and certification journey. This updated guidance supersedes previous statements released by The Joint Commission related to medication compounding.
Therefore, the revision of USP is no longer enforceable. Due to the final appeal decision, the chapter will be reopened, and it is unknown which parts of the chapter will be revised. How will The Joint Commission evaluate organizations that already completed remodeling based on the revision? Organizations that had begun construction Cto be compliant with the revision to USP will meet or exceed the version of USP from a structural perspective, with one exception.
The one exception is that Category 1 compounding was allowed in a segregated compounding area SCA in the revision, but is not allowed in the version. This is because the version addressed compounding from the level of complexity of the compounded product number and type of products prepared together.
The revision categorized compounding according to the location the product was prepared. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Medications that are required to be sterile include those administered through injection, intravenous infusion IV , intraocular injection in the eye or intrathecal injection in the spine.
Understanding the risks inherent in sterile compounding and incorporating established standards are essential for patient safety. Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.
USP develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. For more information on other compounding chapters click here.
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