“We are having our inspection today.” My director’s voice echoed through the lab… A shudder went down my spine as I heard these words. I spent a few months obsessively scouring through the paperwork, making sure everything was in order, every label precise, every corner of the lab spotlessly cleaned. I read the inspector checklist multiple times. Despite it being an incredibly dry read I had read it more than my favorite novel. It wasn’t that I believed the lab would fail, I knew the lab was in order and that everything was fine, but despite everything I had this unshakable, yet irrational, feeling of dread. It lasted hours, the inspectors thumbing through paperwork, asking questions. At the end of it all we passed, and a long sign of relief concluded it.
Perhaps many of you can relate to that feeling when having a lab inspection. Part of being human is fear of failure, that tension and terror that we may be wrong or flawed even if it is irrational. Well, perhaps through a desire to conquer my fear I took the instructions to become an inspector for CAP, and thus I became an inspector. Doing such not only helped me understand the process of inspections, and better understand CAP standards, but it also gave me a new perspective. I am not going to cover all the standards, or answer specific questions on them, with these you can refer to the associated CAP checklist. What I am here to talk about is this perspective.
As tense and stressful as it may be, lab inspections are necessary. Clinical laboratories play a significant role in the treatment of patients. It is my opinion that diagnosis is one of the most essential parts of patient care, as diagnosis determines treatment. Those in the clinical field must remember that these specimens we get in a clinical lab are not simply pieces of tissue, they are a part of our patients and often essential in understanding how to manage the care of our patients.
CAP is an accrediting body for medical laboratories and one of multiple who certify clinical laboratories under the Clinical Laboratory Improvement Amendments regulations, along with CAP standards for best practices. Standards can also change as the best practices and needs in healthcare change. We have standards because we need them, because we all want the reassurance of knowing our family would be getting good care if they are hospitalized. We in the laboratory may never meet them at the bedside, but they are as much our patients as they are for the doctors and nurses on the floor. Clinical laboratory staff owe it to our patients to provide an acceptable standard of care and good laboratory practices.
It is a lot of work, before the inspection the lab must provide proficiency testing reports, instrumentation lists, updated testing menus, a floor space plan, a director’s qualifications, etc. Upon the inspection itself you face the eye of scrutiny from a team of inspectors, often coming with different backgrounds to review the different aspects of the lab. The inspectors review based upon defined standards, CAP accreditation has checklists and I believe most inspections operate similarly. There are various demands for inspections including proper documentation, discipline, proficiency, cleanliness, etc.
I have heard “this isn’t how we do it” before, however standards are standards and if a standard is not met then it is a deficiency. Inspectors are to observe and report, and not to make judgments. An inspector must cite a deficiency based on what they see if it doesn’t meet compliance. Labs may be able to resolve issues during the inspection.
However, if not the inspector will give a report of the deficiencies to the laboratory and to CAP. Deficiencies are addressed by the lab through corrective action plans, and typically laboratories have a month to address deficiencies indicated in an inspection. A deficiency isn’t itself a “failure” and I have not heard of any deficiency leading to a loss of accreditation by itself; what is a failure is failing to properly address deficiencies with appropriate corrective actions which may lead to losing accreditation. Therefore, if you get a deficiency in a laboratory inspection do not let it deflate you and they are not meant to be a condemnation. Deficiencies show us areas in our laboratory practice we need to improve at, see them as a way to better your laboratory. Laboratory compliance is an ongoing process, which is why inspections are done regularly and CAP recommends self-inspections be done within labs.
I will be completely honest, being an inspector is not an easy job and it has a great deal of responsibility. The eyes of scrutiny, the inspectors, are themselves under scrutiny. It requires a great deal of time management trying to cover all that is required even if you are part of a team, and there is a significant degree of paperwork involved. However, it is an important task to ensure that all laboratories provide good quality lab testing and good lab practices, for our patients and ourselves. If you are a Histotechnologist in the clinical setting, specifically if you are a manager or supervisor, I would recommend you take the CAP Inspection training modules. They are free modules for learning and continuing education and will give you a better idea of the inspection process, even if you do not desire to be an inspector.
Farewell, perhaps we shall meet upon your next inspection…
Written by Michael Gubler
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