Note: this post originally appeared in March 2020. It's received quite a bit of attention, so we've updated it and are posting it again.
As we all know, preparing for an inspection should never be a last-minute activity.
Constant discipline and a steadfast dedication to quality are both required. Having the right tools to maintain that vigilance is essential. Today we will go over one obvious but oftentimes underutilized resource you all have at your disposal – checklists from your accrediting bodies.
In the laboratories in which I have worked or those I consulted with, “pre-inspection checklists” were quite common. A fair amount of valuable time and resources went into the creation, management, and maintenance of these checklists. In many cases, I found them to be reactionary – they were created in response to a citation from years past, perhaps in an area that was now well managed. In some cases, the checklists had nothing to do with inspection readiness, but were filled with reminders to carry out various operational or management tasks. In both cases, significant effort went into a checklist that did not address actual inspection items. Meanwhile, one excellent resource sat in the manager’s office, unused.
Regardless of the format you have your accrediting body’s checklists in – PDF, a text document, or on paper, you can make what I call a mark-up copy. If this sounds simplistic, you’re right. It’s a simple tool that an organization of any size can use and adapt to its specific needs.
When this method was used at a laboratory I managed in several years ago, we chose to use a text document (Microsoft Word), and I've included a couple of examples below. At this laboratory, CAP was our accrediting body. Managers in several departments used the CAP checklists in the following manner.
Getting to Work:
The words “if it’s not written down, it never happened” are the best advice anyone can receive in reviewing checklists.
With that in mind, for each question on each checklist, the question was first answered as N/A, YES or NO. If N/A was chosen, the question was skipped, and the user moved on. If NO was selected, you obviously had some work to do. If YES was chosen, then you needed to provide a reference to where the “proof” could be found. Leaving the "proof" section blank was not an option.
We used narrative answers in some cases, and embedded hyperlinks in others – Document Control lends itself well to this approach. In others, directions were included to where a paper binder or a specific manual was located (“Signed copy of paper manual is located in Lab Manager Sally Smith’s office, room 202, Main building”).
that you meet a checklist requirement can sometimes be a maddening
experience. I just knew that somehow my department met a
certain criterion – but was unable to prove it. My pride in my
“perfect” department had taken a blow, but I had to admit that we
could do better. Once the first pass is done, and you know what
needs to be documented, located, or better understood, a list is
made, and each item is resolved. Go back to your markup copy and edit
your responses as needed. Then it’s time for a second set of eyes.
Checking it Twice:
As if admitting to myself that my department could use some work was not difficult enough, it was even more difficult to have another supervisor or manager go through my marked-up checklist. They first had to agree with my assessment on any “N/A” selection. “Why does this question not apply?” “Can you document something that indicates it does not apply?” Yikes! I had not though about that approach...
The second review is on your “YES” responses. The review here is two-fold: “Does the response link to a current, approved document or record?” and “Does the document truly address the question being asked?” More than once I was meeting a checklist requirement, but not necessarily with the resource I had chosen.
Lastly, your reviewer should look at any unresolved “NO” responses. Perhaps she/he has some thoughts on how your lab department really does meet the requirements in the question. Whew!
Here are a couple of examples from the Lab General checklist from CAP. They are a few years old, but still illustrate the approach. Responses and hyperlinks to documents (or specific sections of documents) are included:
1.) GEN.40000 Phase II N/A YES NO
Is there a procedure manual or other source for the complete collection and handling instructions of all laboratory specimens?
of the Operations Manual describes in detail the collection, handling
and transport of a variety of specimen types. Instructions for the
vast majority of routine collections can be found in the Specimen
Collection and Transport procedure.
The ABC Laboratory On-line
provides test-specific instructions for specimen requirements.”
2.) GEN.40491 Phase II N/A YES NO
Are specimens uniquely identified to minimize sample mixups, mislabeling, etc.?
to the Specimen
Specimens are to be labeled with a barcode label as soon as they are
obtained, or in the absence of such labels, with the patient’s
and Last Name and Date of Birth.”
Putting it to Use:
an inspection, managers and supervisors all had access to the
annotated checklists as they were interviewed by inspectors. With a
PC, tablet, or laptop, the linked documents could be retrieved
instantly and provided to the inspectors for their review. Even a
paper copy can be used as a guide to navigate to the correct
documentation. Whatever method you choose, it works.
Does all of this take time? Yes it does. The laboratory is a place of details, and detailed records are a must. It does take time, but a lot less time than writing up and documenting a plan of correction.
Are there automated solutions out there that can accomplish the same thing with a greater degree of automation? Yes, there are. StaffReady has plans in the works for just such an application. Check us out in the coming months for new developments!
Best wishes for your next inspection!
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