Preparing for an Inspection or Accreditation Survey – Part 2

When conducting the tour of your facility, make sure to:  

Interview your staff to help prepare them for the types of questions they may be asked

• Interviews can be done in both a formal, sit-down environment and in an informal setting
• Ask typical questions, in plain language, so the staff can gain confidence in how to answer questions
• Provide feedback at the conclusion of the interview so improvements can be made

Review processes from start to finish, based on each type of business activity or scope of services

• For a pharmacy, review how prescriptions are received. Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling. Go through each step in the process until the prescription is picked up, mailed, or delivered to the patient.
• For a wholesale distributor or a third-party logistics (3PL) company, review how orders are received for a prescription drug/device and walk through each step in the process such as picking, storage, handling, inventory, packing, billing and other communication with the customer, and shipment.
• For each of these business models, you should also review processes for the movement of a prescription drug or device from ordering, receiving, stocking, inventory management and accountability, security systems, selecting, packaging, labeling, and delivering to the customer.
• A review of processes should be done for each scope of service or business activity to encompass the entire operations. For example:
  • For a pharmacy, processes are likely different for dispensing prescription drugs from a manufacturer’s container than for compounded drugs.
  • For a business that has both wholesale distribution activities as well as repackaging, the movement of drugs throughout the facility may look different.
  • For each of these business models, be sure to also look at maintenance of required records, required internal and external reporting (such as theft or significant loss), and quality management.
• Facilities may find the technique of “tracer methodology” to be helpful.

Review each type of record an inspector or surveyor may request. These may include, but are not limited to:

• Employee files
• Patient records
• Facility storage and maintenance records (such as temperature control or cleaning records)
• Movement of the prescription drug throughout facility (such as invoices, inventory, or shipping)