Before Your Next CAP Inspection
Anxiety is high. It’s your inspection year and your time is almost up. The projects that you are working on haven’t slowed down in anticipation of this event, but your to-do list has grown considerably!
Take a deep breath.
A CAP inspection is meant to be collegial. It should be a time to share best practices and maybe even brag a little about the great things that your lab has accomplished. You want to make the most of this opportunity to shine (and maybe learn a few things) by ensuring your laboratory is ready for the inspection. I don’t know about you, but I would much rather spend time preparing for a CAP inspection than responding to deficiencies (ounce of prevention vs a pound of cure…).
Here are a few tips to help prepare you for the upcoming inspection:
Review the standards.
You can’t fix what you don’t know is broken. Review each CAP standard for your area. Ideally this is done during your self-inspection, but you can never review the standards too many times (I learn something new every time!). Think about how you are (or aren’t) meeting that standard. If you can clearly articulate how you meet the standard you should be compliant.
All of the CAP checklists can be downloaded from their website, make sure you download the versions that will be used for your inspection. We download both the PDF version with all of the gory detail and the excel version. As you go through each standard document how you meet the standard in the excel file. When possible reference specific procedures or examples that show that you are compliant, this will keep you from answering yes/no without proving that you are compliant. For standards that you feel you are not compliant with, highlight the cell in excel to make sure you know where to focus your efforts. Use these highlighted cells to create a list of things that need to be addressed prior to the inspection.
Ask your staff (the inspector will too!)
You have created the perfect procedure, job aids, logs, etc., but that doesn’t mean the staff are using them or using them correctly. Most of the staff is more aware than the leadership about how complaint they or their peers are (or aren’t). I would bet if you ask your staff which staff members never complete the cleaning log at the end of their shift they could tell you instantly. My staff is always the first to point out an issue in our SOP. Listen to what the staff says and add it to the list of items to be corrected.
It is helpful to assign different CAP checklist items to the staff and have them help you determine how you are compliant or if they feel you are not compliant. This will give the staff the opportunity to practice explaining what they do and how it aligns with the CAP standard before they are being asked by the CAP inspector. If they feel empowered and involved in the process, they are more likely to take ownership of the process.
You can’t fix everything overnight. As I said previously, there are always a million things to do and never enough time in the day to do them all. Review the list of non-compliant issues that need to be addressed.
- Do any of them represent serious patient care or safety issues? Obviously these should be prioritized as urgent.
- Many of the items on the list will be minor edits to procedures or log forms. These simple fixes can be delegated.
- Develop an action plan to get these issues corrected. Assign due dates and owners for each task and stick to them!
- As items are updated go back into the CAP checklist excel form and update how your lab is meeting the standard.
You can’t do everything by yourself (I know it often feels like we do!). Delegation is the best way to tackle the list of issues. Trust me. I know it is often easier to just get it done yourself so that you know it’s done correctly then to give the task to someone who you will need to review behind them. However if you just do it yourself (working 80 hours a week) you’ve lost a major opportunity here to develop your staff and get them involved.
The techs that assist with CAP inspection readiness will know the CAP standards. They will know why we are saying a cleaning log needs to be completed at the end of the day or why they need to document a run failure. Having the “why” will increase their future compliance. They may even “peer coach” the tech that never completes the log forms! They will become competent to help with the self-inspection and the next CAP inspection. These techs will be ready to speak with the inspector about their lab’s compliance with the standards. The time investment in having the techs help with CAP inspection readiness will be worth it!
Prepare a binder for the staff and inspector.
Now that you and your techs have worked to prove that you are compliant with all of the CAP standards, prepare a binder. In my binder I have printed a:
- CAP Activity Menu (check to be sure everything is accurate, this is one of the most frequently cited deficiencies)
- Copy of our test menu
- PDF version of the CAP checklists that will be used for my inspection (make sure it’s the right version!)
- Excel version of the checklists (now updated to clearly documents how each standard is being met)
- Any example or procedure that you referenced can be printed and added to the binder with flags to easily allow techs or the inspector to find it
- Our Self-inspection Deficiency Summary Form
- A list of assays implemented in the last 2 years
- Our LDT & Modified FDA-cleared Test List
- Our Laboratory Personnel Evaluation Roster
This binder can be used by the staff to see how their lab meets a standard. It will also be invaluable if you have an emergency and can’t be at the lab on inspection day. This binder can be given to the inspector or you can use it to answer a difficult question from the inspector. The inspection process often causes anxiety, this binder will help you and your techs answer questions during the stressful time.
This binder should be updated as new checklists come out. Also take the time to update the binder as your test menu changes or you make edits to a procedure. This will help you stay continually ready.
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Molecular Diagnostics Scientific Director, Sentara Healthcare