Volume 2025 | No. 2
SURVEYOR
PHARMACY
■ Deliveries handled via local courier were not addressed in policies and procedures for the courier's process for maintaining temperatures of deliveries within their vehicles, how to handle excursions, process for storing the medication when the delivery can’t be made. Driver's training was not documented. ■ Nurses at the organization sometimes transport medications between locations. The organization does not have any temperature studies to support this scenario. Compliance tips for: Nerd Newbies (understand the requirement) Note: This standard is similar to PCAB Standard TCRX6-D. ■ Shipping systems need to be validated by a third party or internal studies. The validation includes: ٝ Initial product temperature. ٝ Payload size/weight. ٝ Types of insulation used and thickness of insulation.
DRX7-9B Frequency of the citation: 28%
Overview of the requirement: The organization uses a validated shipping system to ensure pharmaceuticals are maintained under appropriate sanitation, light, and temperature conditions during delivery. Comment on deficiencies: Compliance is assessed through observation, response to interviews, review of shipping records, and review of policies and procedures. Surveyors found that most organizations validated shipping, but testing methods were not addressing all temperature variants and container sizes. Deficiencies were also cited for inadequate instructions and training for shipping staff. Examples of ACHC Surveyor findings: ■ There was no evidence of testing of shipping methods to ensure containers stay within specified temperature requirements. ■ Shipping validation testing policies do not match what is currently in stock for shipping supplies. ٝ Policy does not include the container-sizes currently used by the pharmacy. ٝ The pack-out calls for 48-ounce frozen gel packs, but the location only had 16-ounce and 24-ounce gel packs onsite. ٝ The pack-out called for buffer pads, but the location was using bubble wrap as the barrier. ■ Room temperature shipping was not addressed in policies. Pharmacy ships ambient items using USPS and should consider temperature variants that can occur in the summer/winter. ■ While the organization did have shipping validation and packing instructions that included extreme heat, they did not have any for extreme cold of less than 32° F. ■ Upon interview, pharmacists were unable to describe how the pharmacy ensures the shipping containers stay within the specified temperature range. ■ The organization does not provide staff with detailed pack-out instructions/directions. ■ Pharmacy’s validation studies do not contain: ٝ External/environmental temperature range. ٝ Initial product start temperature. ٝ Payload size/weight. ٝ Types of insulation used and the thickness of the insulation. ٝ Weight of phase change material and phase change material start temperature. ٝ The ambient temperatures experienced by the package in transit.
ٝ Weight of phase change material and its start temperature. ٝ A range of ambient temperatures likely to be experienced by the package in transit with the goal of keeping the pharmaceutical at the temperature described by the manufacturer, USP, and/or other applicable requirements. ■ Review policies and procedures to ensure that they include requirements for periodic testing to ensure containers stay within specified temperature ranges. ٝ Conduct shipping studies that include all means of transportation. ٝ Develop a packing guide so that all staff know exactly how to pack temperature-sensitive containers with the required amount of freezer packs.
Nerd Apprentices (audit for excellence)
■ Audit packouts to verify compliance with packing guides.
■ Develop a shipping study template for documenting the specific details of shipping validation tests and for recording the results at the conclusion of the test (e.g., pass or fail). The template could also include an area for documenting the observation competency of the staff member conducting the shipping validation test.
Nerd Trailblazers (prepare the path for others)
achc.org | (855) 937-2242 | 55
54
Made with FlippingBook - PDF hosting