Top 5 Most Common PSL Findings
NABP DDA accreditation consists of three main parts, which are the application review, policy & procedure review, and the on-site survey.
In the application review, NABP reviews materials submitted with the application, including the online application information, ownership information, business model description, license list, customer list and the vendor list. In these materials, NABP primarily looks for issues with secondary vendors and licensing, and they will also perform a cursory review of policies & procedures to ensure they are relatively reflective of the facility’s procedure. During the policy & procedure review, NABP ensures that processes meet the intent of NABP Drug Distributor Accreditation standards. Once NABP is satisfied with a facility’s policies & procedures, a surveyor physically comes on-site to your facility to review your various documentation, observe processes and interview staff. After the on-site survey, it is common to receive a PSL, or a “post survey letter” in which the NABP lists the findings from the survey that they would like to be addressed by the organization.
1. Cold Chain Validation
Cold chain validation refers to the packaging processes that must be established by your organization that ensure product integrity throughout the delivery process. Product integrity is ensured by maintaining temperature and humidity requirements as specified by the drug (or device) manufacturer. The NABP surveyor will request to see your validation, or “proof”, that you are able to maintain product integrity, so it is imperative to have strong records on any testing performed as well as calibration records on temperature and humidity monitoring equipment for cold storage unit.
2. Crisis Operations
A crisis can include several different scenarios, including power outage, flood, bomb threat, or active shooter situation. It’s important that your organization is able to ensure that product security, product integrity/quality, the maintenance of critical prescription drug and device records, and business continuity are maintained during emergency conditions. NABP wants to see that you have established processes that adequately address the facility’s security and operations in the event of a disaster. Such processes must include:
• Product and records management
• Backup or outsourced resources (power, security, storage)
• Processes for maintaining a current employee phone tree
• Reporting to NABP, DEA, and the state when facility is rendered inoperable for 10 or more days
3. P&P Adherence
The surveyor will observe to ensure that applicant maintains and utilizes policies & procedures that describe all required processes performed at its facility. In plain terms, the surveyor will be watching to make sure that your actions match the policies & procedures that were submitted with the application.
4. Inventory Accountability
Establishing inventory accountability controls is imperative for all prescription drugs/devices stored at your facility. The NABP surveyor will want to ensure that your organization maintains adequate processes for disposing of outdated, damaged and/or recalled product so that it cannot be sold. When product is placed into quarantine, it will need to remain in perpetual inventory for purposes of tracking, inventory control, product integrity, and security. Obtaining and maintaining proper product destruction records from vendors utilized for destruction of prescription drug/device product is a must. Ensure that access is limited to the product storage and processing areas to authorized, task-critical employees. All employees deemed to not be task-critical should have limited access and be escorted in a manner that is similar to visitors or outsourced cleaning and pest control personnel.
5. Temperature and Humidity
This topic is different than #1 in that this section refers to temperature and humidity monitoring in the facility whereas #1 talks about maintaining product integrity during the shipping process. Your facility should have a sufficient number of temperature and humidity monitors or probes in place to adequately cover processing and storage areas and are appropriately located in order to provide accurate data indicative of the storage conditions. According to the World Health Organization (WHO), probes should be within 16 to 32 feet apart. It is required that your facility have established processes and procedures for conducting product assessments should a temperature and/or humidity excursion occur. Have proof that alarm will sound outside of temperature requirements (68-77 F) and have electronic printouts of recorded temperatures/humidity ranges that are reviewed and signed by a supervisor.