Every time we present at ACHC University the same questions come up, usually in the same order. How long does my pack-out actually hold? Can I get more hours out of it? What happens when I ship nationwide and the same product goes to Phoenix and Minneapolis in the same week? And then, from whoever has a survey coming, what is the surveyor going to want to see?
Inside a pharmacy those are all one question. The answers just happen to sit in two different companies, which is most of the reason we work with the Accreditation Commission for Health Care (ACHC).
Nobody owns the whole cold chain
Our world at TempAid is temperature-controlled packaging. Thermal performance, packaging design, qualification, and what happens to a shipment once it leaves a controlled environment. That is a narrow slice of what a pharmacy is actually responsible for.
Around the package sit operational procedures, accreditation standards, quality systems, documentation, staff training and patient safety. Those pieces usually belong to different people who never get much time in the same room, and the gaps between them are where shipments go wrong.
What we do with ACHC
TempAid is a listed ACHC Strategic Partner. We present at ACHC University every year, we run educational webinars for specialty pharmacies through the year, and ACHC members get preferred pricing on our packaging.
The education side is the part we care about most. ACHC pharmacy standards address shipping methodology alongside patient and employee safety, organizational oversight and quality improvement, so their accredited pharmacies are already being asked to show that their shipping method works. We spend our time on the how.
How long does it hold
Most pharmacies have a number in their head for their pack-out. 24 hours, 48, 72. Ask where the number came from and it usually traces back to one test somebody ran once, in one season, in a chamber.
USP <1079> is fairly direct that this is not enough. It asks for testing against actual environmental extremes rather than one successful run. A system that holds 48 hours leaving Ohio in October behaves differently in July, and differently again sitting on a dock in Phoenix.
Nationwide shipping makes it harder again. The same packing going to four different climate zones around the country is four different shipping lanes, and answering the duration question honestly means having data that covers the range.
The “can I get more hours” question usually goes one of two ways. Sometimes there is real room in a different refrigerant configuration or in how the product is conditioned before it gets packed. Other times the system is already fine and what the pharmacy is missing is the evidence to prove it.
Where TempAid comes in
TempAid runs its own lab, so the chamber work happens in house and we can put a system through the profiles that match where a pharmacy actually ships instead of the profile that makes a product look good.
The bigger piece is the field testing. Most of it we facilitate virtually. We write the protocols and the SOPs, walk the pharmacy team through the PQ, and work through the results with them as the shipments go out. When a pharmacy needs us in the building, TempAid will come on site and run the field testing with them. It gets decided case by case, and the point of doing it both ways is that every pharmacy has a route to the data behind its shipping method, whatever its size.
Field testing turns up things a chamber never will. Somebody packs it differently than the SOP describes. The shipment sits longer than anyone planned for. The refrigerant was not conditioned the way the protocol assumed. None of that shows up in a lab report.
At the end of it the pharmacy has a duration it can defend, the documentation behind it, and a written procedure that matches what the team actually does. That is also what a surveyor is looking for, and it is what a safe patient experience is built on.
Why the partnership is worth having
Compliance does not start when a survey shows up on the calendar. It gets built into how a product is packed on an ordinary Tuesday, and by then it is too late to go hunting for qualification data nobody ever generated.
ACHC brings the accreditation knowledge and an educational approach to helping pharmacies meet the standards. TempAid brings the testing and the packaging. Neither of us is trying to do the other one’s job, and a pharmacy should not have to stitch the two together on its own.
There is a patient at the end of every one of these shipments waiting on a product that has to arrive in range. Getting that right takes both organizations.
