Facing audits is a way of life for those of you managing a laboratory.
As a Doctor of Veterinary Medicine, it's important you have proper reports ready for your audits so you don't face any compliance issues. The question is, are you really prepared to get those reports ready?
With you and your staff overworked, you may not have any time to put together a pathology report. Yet, the FDA defines these reports as official raw data during audits.
Those of you new to the field might have found initial confusion about this. Go back and read the FDA's definition of what constitutes raw data under GLP. You'll discover why pathology reports definitely are raw data and why you should outsource to get an accurate report done.
Reasons for Not Being Able to Create a Report
No doubt you're facing a litany of reasons behind why you can't create a pathology report for an upcoming audit. One of the most critical is perhaps due to staff shortages.
Maybe you've had to make some staff cuts recently due to budget shortfalls. As a result, you realize the risk in placing your employees in a role they aren't completely sure how to handle.
It's a smart move to not force a pathology report on lab staff who don't know what they're doing. Since you may not have time for training at such short notice, it's time to think about outsourcing as an option.
Sending Your Animal Tests to an Outsourced Lab
Your main pathology specialty is perhaps as a cancer research organization. As such, the tests you do on animals require a lot of exacting techniques when dosing animals. You'll need to process this to slides, something you're possibly not able to accommodate.
One other reason to outsource is that you may have a lack of space within your lab. This alone makes creating slides a major problem. Considering how exacting creating slides is, outsourcing it to a pre-clinical contract research organization catering to large pharma and academia can bring a lot more convenience.
So if you do outsource, what steps will a third-party lab take to assure you get an accurate pathology report for your audit?
Sending to Board-Certified Pathologists
If you're going to outsource your pathology slides to another lab, you have to vet them thoroughly to assure all their pathologists are board-certified. Don't just take their word for it, because some outsourced labs cut corners just to attract business.
Have them assure all their pathologists have proper training and certifications. Meeting them in person, requesting CVs, and touring the lab helps so you know you're dealing with a quality provider.
Once you're assured of their board-certified status, they'll take your slides and microscopically examine them. Then they'll compile this information and place it into a pathology report. When you need that report in a hurry for an audit, you'll find other good news when you outsource.
Obtaining Your Pathology Report Quickly
Audits can occur without warning, so obtaining a pathology report as quickly as you can is something you may need. Can you trust the third-party lab to send you the report in a timely fashion?
The greatest aspect to outsourcing is that you're going to have a pathology team with years of experience and knowledge on how to do their tasks well. This means being able to work fast without other distractions.
A quality lab won't force you into waiting weeks or months for a report when time is of the essence.
Here at HSRL. we're a pre-clinical CRO that can outsource numerous lab services, including pathology reports. Contact us to find out more about our experience and team of dedicated lab employees who work on your behalf.