First, following these tips will not ensure citations are not issued. This guide is designed to help you survive your first, or hundredth, inspection. Feel free to leave your tips in the comments below.
I have led or been part of a team that has hosted dozens of inspections over more than two decades. Below are some tips on how to prepare for your first inspection, respond to your inspector, and survive with your sanity intact.
I may be glib at times in this post, but I do take this process very seriously. You may lose a prestigious accreditation, or worse, the ability to perform a critical test. Occasionally substantial fines can be involved. Rarely, prison sentences are imposed.
Keep good notes. document everything and keep copies of everything – more below.
Keep people apprised. I suggest creating a group email address now, not on the day of the inspection, but now. It should include your leaders, leaders of other areas that may be impacted – Nursing, Admissions…, your direct reports (unless that is line staff), and others that may need to know. I promise you will forget someone, that’s OK, add them to the list and move on. On the arrival of the inspectors, send a quick note to that list letting them know basic details: agency, areas they are likely to review, expected length of inspection, time / location of the opening meeting (if there is one).
Create an email to send to staff, do this now, again not on the day of the inspection. Save it somewhere as a Word document so you can quickly copy and paste the information into an email. It should include items such as, only answer what you are asked, ensure you have your institution provided ID worn as required, say “I don’t know, I would ask my manager…”.
At the end of each day, send out a summary to the leaders list. If there are findings, let the leaders know. Also notify line staff. This is an inspection of their work; they need to feel proud of what they have done. You may want to hold back on any citations (if any) until you have developed a fix.
Types of Inspections
The terms below are a few of the more frequent organizations you may encounter during an inspection. There are several terms used for the process, for the purpose of this post, I will use “inspection” to represent the different terms, and “agency” to capture all inspection organizations. For anything that goes awry and is documented as needing improvement, we’ll use “citation”.
- FDA Inspection
- AABB Assessment
- TJC Survey
- CAP Inspection
- FACT Inspection
- ISO Conformity assessment
- GCP Inspection
Inspections are designed to be a surprise. Some agencies will give you a window of when they are likely to arrive, others do not provide any information at all. This is by design. It is the expectation of the agency that you are always ready for an inspection.
You are always ready to perform testing on a patient specimen, correct? The same should be true for an inspection. You need solid processes in place for all the items an inspector will look for. These are important for inspections, but more important for patient testing.
A short list of activities you need to have procedures for, and most important, documentation, follow:
- Correlation studies
- Transfusion Reaction Investigations
- Competency Assessment
- Training (this is not competency)
- Equipment maintenance records – as required by the manufacturer
- Quality control (signed by an approved person)
- Personnel records – evidence of an annual review, qualification for their position
- How to write an SOP
- Organizational structure - this does not need to be a beautiful chart, it can be as simple as a listing of what position reports to whom, and their general duties
Speak When Spoken To
Think of an inspection as a first date. You will be nervous, regardless of this being your first inspection or 20th. There will be many times of extended quiet – sometimes an hour or more. Bring your laptop, cellphone, or something else private for you to work on in the presence of the inspector.
During these quiet times, you may get extra nervous. The inspector may take notes, may mumble to themselves while reviewing an SOP, may furrow their brow when looking over quality control records… do not be tempted to ask if they need anything. Trust me, they will ask.
Do not be belligerent but be close. When asked a question, answer the question honestly and fully, but only to the point of answering the question. For example, you’re asked “Do you perform quality control on reagent xyz?”. Answer according to your SOP, then stop talking. Do not respond with “Yes, we perform daily quality control on reagent xyz; however, we feel we could improve how we document this information and have begun a process improvement project to address this.”. This will lead to more questions, and a possible citation.
Sadly, we’ve all had the inspector who will respond, “No worries, it’s not an actual rule, but it’s they I’ve always done it.”. Do your best to smile (at least inside) and do not respond.
You know where your weaknesses are. Please do not point them out (see the section above). If an inspector fails to uncover a process you plan to improve, no harm is done.
If an inspector asks about a process you are not performing correctly, answer the question directly. For example (US based) “I was reviewing employee 123’s training record. I see you’ve done a terrific job training them on Process ABC. I really like your training documents, great work. I also see they have documented independent performance of test ABC one week after they were trained. Please show me the documentation of their competency assessment.”. You do not have this documentation. Uh oh. You’ve been caught, own up to it. A possible response: “Thank you for recognizing the hard work we put into training our staff, we really are proud of it. As you noticed, employee 123 does not have documented initial competency, this is something we are working on. Can I show you our project plan for bringing this into compliance?”. This is a serious concern for inspectors, and you may be cited, you may not, based on your project plan. The crucial point is to not argue with them.
Do Not Argue
Should an inspector find something they don’t find quite right, ask for clarification. Something that I found helpful is, “Thank you for pointing that deficiency out. We take our work very seriously. As you can imagine, process change is a critical step in our continuous quality improvement and needs to be agreed upon by senior management. Can you please let me know what regulation I am not fulfilling – specifically with the rule number.”.
If you are going to be cited, you are going to be cited. Do not get defensive, do not argue, do not try to negotiate. There is time to do that in your response.
Ask for Specifics
Let’s say the inspector say, “Please show me quality Control.”. That’s a big request. Ask for clarification.
You: “I would be happy to provide you quality control information, can you please be more specific?”.
Inspector: “Yes, I want to see reagent quality control.”.
You: “Can you please provide a date range for the records you would like to see.”.
Inspector: “Please give me last month, and the same month for the prior year.”.
You: “Is there a particular reagent or process you would like to see?”.
You get the point. You are not trying to be uncooperative or unhelpful. You only want to provide exactly what they need. More is not better. Do not attempt to bury them in data, they will find every unchecked box and unreviewed document you have.
Document What They See
Always provide an escort for your inspector(s). Never let them walk through the laboratory on their own, even to go to the restroom. Clearly do not follow them in; however, observe them as they head out of the laboratory toward the restroom, then stay within sight of where they will return. They will be observing what is going on as they walk through, and if something piques their interest, they may stop and ask questions. You need to be present for this, so you have a firsthand account of what transpired.
Many times, an inspector will ask for documents to be provided as a copy. Depending on the agency, you may not be allowed to redact. One example in the US is the FDA. Unless you are given permission to redact, you must provide anything they ask for, including private / protected information.
Always make a copy for the inspector and an identical copy for yourself. Keep these documents in your folder for that inspection and maintain them.
Do a Gap Analysis
Performing a gap analysis is an amazing opportunity. Pick the most critical set of rules you’re required to follow. It’s wonderful when these rules are available for download. Don’t make the process overly complicated. Add the rule to a column in a spreadsheet. In the next column document the exact location in the SOP where you are fulfilling this rule. Some document management systems allow for the recording of this, but if you do not have this available to you, again, a simple spreadsheet will suffice.
I assure you, you’ll learn a lot doing this exercise, most importantly, that there will be items you assumed were in your procedures that are not.
This is a fun process, but it takes resources. If you are doing this on your own it could take months, maybe an entire year. Ask your staff for help. Give them clear instructions on what you need them to do, give them small chunks at a time to work on. I promise they will enjoy the education and chance to help improve your overall quality.
There is zero chance you will complete this task with no processes to improve. This is OK. Now you know where your weaknesses are and can prioritize working on them.
Response to Inspection
Most agencies tell you how they want you to respond, and when. Examples: AABB has a format they prefer you to follow when responding – use their document. TJC has timelines for when items must be corrected, and more timelines for evidence of these corrections - meet these timelines. FDA (unless it’s a Warning Letter) does not expect a response.
The key point, the inspecting agency has a proposed format, use it. Never be late with your response. If circumstances do not allow you to meet the deadline, well in advance of when your response is due, ask for an extension. The agency will often grant one.
If the agency does not require a response, respond anyhow. For instance, if the FDA finds one item that needs attention, write to them thanking them for their time, let them know you appreciate the thoroughness of their investigation, and describe specifically how you have corrected the deficiency. They will likely mention this the next time they visit, and it will set a positive tone for that inspection.
If you are fortunate enough to survive the inspection without a citation, still write a letter thanking the agency for their time.
This may be your first inspection, but it will not be your last. It is part of doing business in a laboratory. Accept that fact. Develop a procedure for inspections: do you provide parking; do you offer lunch… Learn from missteps you had during each inspection.
Most important, don’t take a citation personally. Learn from what your inspector provided you and get better.