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.
Regardless of the format you have them in – PDF, a text document, or on paper, you can make what I call a mark-up copy.
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.
We used narrative answers in some cases, and embedded links 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”).
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:
Have another supervisor or manager familiar with your area go through your marked-up checklist. They must first agree with you on any “N/A” selection you have made. Why does this question not apply? Can you document something that indicates it does not apply?
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?
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.
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 highlighted in yellow:
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?
“The Pre-Analytic Section 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 Test Directory provides test-specific instructions for specimen requirements.”
GEN.40491 Phase II N/A YES NO
Are specimens uniquely identified to minimize sample mixups, mislabeling, etc.?
“Refer to the Specimen ID Procedure. 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 First and Last Name and Date of Birth.”
Putting it to Use:
During 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. 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!
Best wishes for your next inspection!