Specialty Pharmacy (4.0) 4.0

PROD 5-1: Access Levels

Submited by: Tom Goddard

The Basics

Facility and employee safety and security are the focus of this standard. 
To ensure the security of the facility, the pharmacy must:

  • Designate access levels to the facility itself and/or to areas within the facility; and
  • Identify clearly which employees should have access to which machines and equipment, including the authority and ability to operate the equipment locks.

Management Tips

The management responsibilities are straightforward:

  • make sure your policies continue to comply with the requirements of this standard, 
  • ensure that your staff members are trained in those requirements; and
  • document both your training and your oversight of the implementation of your policies.

Accreditation Tips

Desktop Review
The only documentary requirements for this standard are your policies and procedures regarding facility security.
Validation Review
Assuming that the URAC reviewer conducts the review onsite, that review will involve an observation of how the pharmacy's team is implementing your policies and procedures.

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