As a wise pathologist told me once, inspections are like death and taxes: always be ready. That is just one piece of sage advice I’ve picked up in my 3 decades’ experience as a lab inspector, and in my many years on the inspection receiving end as a lab manager. After performing more than 500 inspections, I can state without hesitation that preparation is the key to making the process go smoother.
Perhaps the foundation of having a relatively straightforward inspection is staff readiness. I recommend assigning a checklist to a technologist in each area. Make this individual responsible for answering each question on the checklist and drilling other staff in that area of the lab. The more staff members are aware of the checklist the better the inspection will go. Drill each other! I have been in labs where some staff have never seen a checklist, which slows down the inspection and results in deficiencies.
In addition to lab staff, alert hospital administrators about the upcoming inspection and provide them with a list of questions that might be asked.
Checklist as Bible
Each regulatory entity will have its own checklist, which should be your bible for both advance and day-of inspection planning. The more you look at the checklists, the more you will be ready for the inspection and prepared to answer whatever the inspectors ask. A good way to prepare is to create a book of evidence, placing copies of procedures behind each checklist question. Whether you keep paper copies of your procedures or maintain them digitally, have these invaluable documents available the day of inspection. In the case of print, have all the books in one place. If your procedures are in digital format, reserve computers for the inspectors’ use. Nothing is more frustrating during an inspection than waiting to access electronic files or paper copies.
I recommend maintaining a book dedicated to your quality management plan that includes all areas of the lab and the monitors you’ve chosen for pre-analytical, analytical, and post-analytical testing phases. All indicators should be important for patient care, and inspectors need to see an annual evaluation of the plan with documented corrective action for indicators not met. This might be a good place to add your customer satisfaction results.
Inspectors also turn up safety-related issues in safety walkthroughs and elsewhere. Is there documentation that you have checked your fire extinguishers and eye wash within the appropriate timeframes? Are the secondary containers for chemicals appropriately labeled and stored? In my experience, attention to these details makes inspections a little shorter and less stressful, and perhaps even spares some labs from receiving deficiencies.
Another thing to have at the ready for inspectors is your proficiency books. I recommend keeping raw copies of instrument results with the survey report. From an inspector’s perspective, it is very cumbersome to hunt for the raw data because it wastes time. Make sure all attestation pages are signed. You cannot just print out a copy after you have sent it electronically. As an added attention to detail, the lab’s medical director must have signed the transfusion attestation page.
Inspectors also will expect to look through your safety log book with an eye for things like: a chemical list identifying carcinogens, toxins, and reproductive toxins used in the lab; a record of safety audits that you have conducted (at least 1 per year); evidence of having checked outlets and spill kits; documentation of disaster drills; evidence of International Air Transportation Association training on packaging and shipping hazardous substances; and evidence of fire extinguisher training.
You also can count on inspectors sampling or looking page-by-page through your maintenance logs. Of course, these logs should be complete with evidence of having been reviewed monthly.
On the Personnel Front
As most laboratorians know, inspectors will be looking through licensure and personnel records during the inspection. This area remains a sticking point, as problems with personnel records continue to be one of the most common sources of inspection-related deficiencies. To sail through this aspect of the inspection, have your personnel files readily available and complete with all necessary records. These include copies of each staff member’s diploma or transcript, lab license, training, and state license (in states where required). Don’t forget copies of job descriptions, records of continuing education, and documented dates of employment. If your lab operates in a state that requires laboratorians to be licensed, prepare a book that contains copies of all employees’ licenses. You might also include a copy of their college diplomas in this book.
Staff competency is crucial to ensuring that the total testing process is of highest quality, and is therefore a key regulatory requirement, so inspectors will look closely at labs’ competency assessment documentation. Yet as an inspector, I consistently find that competency assessment materials lack documentation of all six required elements, in the required intervals.
Labs that attend to these details should have less stressful inspection experiences, and be better able to converse with their inspectors about improving the total testing process—the goal of all involved.
Mary Cline, BSMT, (ASCP), is laboratory director at Baptist Memorial Hospital in Collierville, Tennessee, and an active lab inspector with more than 3 decades’ experience.+Email: firstname.lastname@example.org