CMS SOM App. L, Tag Q-0180

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.