In my long experience, clinical laboratory directors have looked forward to inspections of their operations with the same basic dread that accompanies public speaking or a letter from the IRS. Yet, the degree of this inspection anxiety has puzzled me over the course of my career. Having been on both sides of the clipboard through some 20 inspections, I have often thought they can be taken a bit too seriously.
To be clear, any regulatory or accreditation inspection should be taken seriously, but it is beneficial to view the process as an opportunity to fine tune the laboratory, rather than as an annoyance at best, or a death knell at worst. Some take the view that an inspector may feel they are not doing their job unless they find a problem and I understood that when I inspected laboratories myself. However, my primary goal as an inspector (and I think this was common) was to collaborate with the laboratory in question and share ways in which my fellow inspectors could work to the betterment of the laboratory and institution at large. After all, those same laboratory personnel could be inspecting my lab next, so a sense of collegiality is essential.
Furthermore, it is commonly the lab manager that is under pressure from administration to perform well and positively represent the laboratory, which partly explains the unreasonable lengths some labs will go to in the attempt to ward off any citation. My feeling was always this: Do your best to meet the guidelines, but do not be afraid to get cited. In almost every case, a citation is simply an identified opportunity for improvement. Once addressed, this absolves the citation. Moreover, spending significant time and resources attempting to prepare for every possible scenario likely detracts from your ability for day-to-day process improvement.
Familiarize Yourself with the Inspection Process
Again, every reasonable attempt should be made to gain and remain in compliance with regulatory and accreditation agency, and state and federal guidelines and standards. That said, some requirements can be vague or involve redundancies, and spending an inordinate amount of time attempting to satisfy a requirement that is unclear to begin with can be unreasonable. Therefore, the laboratory director should embrace the inspection process as an opportunity to bring clarity to any obscure issues in a specific lab.
As an example, our lab purchased a new coagulation analyzer from the same manufacturer as our previous analyzer, and which uses the same methodology and reagents. I was aware the inspection requirement indicated that an activated partial thromboplastin time (aPTT) test had to be verified with a heparin assay if a new instrument was in use, but I reasoned that given the similarity in devices, they were essentially the same instrument, and additional verification was not necessary. However, this was cited during inspection, and I made the correction by redoing the assay. This was a learning experience for me and informed future inspections, as should be the case.
While inspections can be stress inducing, an important aspect of a laboratory director’s role is to be prepared for the unknown and react quickly and decisively. This requires comprehensive vigilance of operations—the How and Why behind operational workflow. Keep in mind that the inspection process should work both ways; a good inspection should challenge the inspector as well. No laboratory will be completely prepared for all possible scenarios, but there are general guidelines (in addition to the readily available inspection checklists) that can be beneficial in preparing your laboratory for an inspection with very little dread and perhaps even with, dare I say, confidence and anticipation.
A Framework for Inspection
I have found the following suggestions to have been useful over the years, whether you are the inspector or the one being inspected:
Before every subsequent inspection, go through the list of new and deleted questions from the inspecting agency and update your notebook. Done well, this becomes a self-guiding document for the inspection, and even those with little experience in that specific department (eg, part-time employees and rotators) can easily satisfy the needs of inspectors.
Furthermore, if you have policies that are no longer practiced, remove them or risk being cited, even if the policy is not required by the checklist. Inspectors are unlikely to take issue with additional policies above the requirements, but whatever the policy, be sure it is supported by some type of documentation. It also may be helpful to keep a record of outdated or obsolete procedures with the date they were retired.
Fortunately, inspection questions tend to focus on similar areas from visit to visit, so the process should get progressively easier for everyone involved. Accomplishing a lab inspection can be a great relief, no matter how well you do. As always, try to take the viewpoint that these activities should serve as opportunities to improve, which all laboratories are subject to. Every lab is unique, so the tips herein should serve as a rough guide for your own, custom approach to inspection. That said, all will benefit from an early start, and a strong finish can turn the lab inspection process into an event to anticipate, accomplish as a team, and be proud of.