11. Pharmaceutical Services

(Rev. 56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
§416.48 Condition for Coverage: Pharmaceutical Services
The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services.
Interpretive Guidelines: §416.48
Drugs and biologicals used within the ASC must be provided safely and in an effective manner, consistent with generally accepted professional standards of pharmaceutical practice and with the requirements specified in the Standards within this Condition.
The ASC must designate a specific licensed healthcare professional to provide direction to the ASC’s pharmaceutical service. That individual must be routinely present when the ASC is open for business, but continuous presence is not required, particularly when the ASC is open for longer periods of time to accommodate the recovery of patients for up to 24 hours. Ideally the ASC should have available a pharmacist who provides oversight or consultation on the ASC’s pharmaceutical services, but this is not required by the regulation, unless the ASC is performing activities which under State law may only be performed by a licensed pharmacist.
Survey Procedures: §416.48
• Ask the ASC’s leadership for evidence that a qualified individual has been designated to direct pharmaceutical services in the ASC.
• Ask how often and for how long this individual is on-site at the ASC. Determine whether there is any documentation indicating that the individual is providing active direction and oversight to the program.
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