Lab Inspections from Both Sides of the Clipboard

September 2021 - Vol.10 No. 8 - Page #2
Category: General Labware

In my long experience, clinical laboratory directors have looked forward to inspections of their operations with the same basic dread that accompanies public speaking or a letter from the IRS. Yet, the degree of this inspection anxiety has puzzled me over the course of my career. Having been on both sides of the clipboard through some 20 inspections, I have often thought they can be taken a bit too seriously.

To be clear, any regulatory or accreditation inspection should be taken seriously, but it is beneficial to view the process as an opportunity to fine tune the laboratory, rather than as an annoyance at best, or a death knell at worst. Some take the view that an inspector may feel they are not doing their job unless they find a problem and I understood that when I inspected laboratories myself. However, my primary goal as an inspector (and I think this was common) was to collaborate with the laboratory in question and share ways in which my fellow inspectors could work to the betterment of the laboratory and institution at large. After all, those same laboratory personnel could be inspecting my lab next, so a sense of collegiality is essential.

Furthermore, it is commonly the lab manager that is under pressure from administration to perform well and positively represent the laboratory, which partly explains the unreasonable lengths some labs will go to in the attempt to ward off any citation. My feeling was always this: Do your best to meet the guidelines, but do not be afraid to get cited. In almost every case, a citation is simply an identified opportunity for improvement. Once addressed, this absolves the citation. Moreover, spending significant time and resources attempting to prepare for every possible scenario likely detracts from your ability for day-to-day process improvement.

Familiarize Yourself with the Inspection Process

Again, every reasonable attempt should be made to gain and remain in compliance with regulatory and accreditation agency, and state and federal guidelines and standards. That said, some requirements can be vague or involve redundancies, and spending an inordinate amount of time attempting to satisfy a requirement that is unclear to begin with can be unreasonable. Therefore, the laboratory director should embrace the inspection process as an opportunity to bring clarity to any obscure issues in a specific lab.

As an example, our lab purchased a new coagulation analyzer from the same manufacturer as our previous analyzer, and which uses the same methodology and reagents. I was aware the inspection requirement indicated that an activated partial thromboplastin time (aPTT) test had to be verified with a heparin assay if a new instrument was in use, but I reasoned that given the similarity in devices, they were essentially the same instrument, and additional verification was not necessary. However, this was cited during inspection, and I made the correction by redoing the assay. This was a learning experience for me and informed future inspections, as should be the case.

While inspections can be stress inducing, an important aspect of a laboratory director’s role is to be prepared for the unknown and react quickly and decisively. This requires comprehensive vigilance of operations—the How and Why behind operational workflow. Keep in mind that the inspection process should work both ways; a good inspection should challenge the inspector as well. No laboratory will be completely prepared for all possible scenarios, but there are general guidelines (in addition to the readily available inspection checklists) that can be beneficial in preparing your laboratory for an inspection with very little dread and perhaps even with, dare I say, confidence and anticipation.

A Framework for Inspection

I have found the following suggestions to have been useful over the years, whether you are the inspector or the one being inspected:

  1. Start by creating an Inspection Notebook prior to the inspection. Incorporate the inspection checklist into a physical (or digital) binder with the intention of listing both the questions and answers to all questions posed by and to the inspector. For example, if the inspector asks, “Is there a lab policy for aPTT testing for high-hematocrit patients?” note the question, as well as where the policy is kept (eg, Coag procedure manual, aPTT test, p 4). Furthermore, copy the page of your document that pertains to the question and insert it after the inspection page reference.

    Before every subsequent inspection, go through the list of new and deleted questions from the inspecting agency and update your notebook. Done well, this becomes a self-guiding document for the inspection, and even those with little experience in that specific department (eg, part-time employees and rotators) can easily satisfy the needs of inspectors.

  2. Review your last inspection results well before the new inspection. It is important to avoid repeat deficiencies in the same areas. Failing the same item twice in a row can become a serious offense, including being barred from performing a failed test.

  3. Check all prothrombin INR, patient normal, and ISI settings. A serious deficiency involves mismatches on coagulation instrument settings versus the indications on the thromboplastin bottle and insert, and the reported patient result. Inspectors will always check this crucial item given the potential for substantial impact on patient care. Print a patient report with the INR, then print the same result directly from the instrument, and copy the thromboplastin insert. These should all be added to the Inspection Notebook.

  4. Ensure attention to temperature logs. No inspector wants to see blanks in refrigerated storage temperature charts, and while this is an area of lab practice often relegated to the back of the mind, strict control over temperatures (and attendant documentation) is crucial. Given the advanced, medical-grade refrigeration devices and wide range of temperature monitoring devices available, this has become a simple item to comply with, and the resulting confidence in product and specimen integrity is certainly worthwhile.

  5. Ask inspectors the reasoning behind questions. If a question seems vague or unreasonable to you, see if the inspector has the knowledge and experience to defend the item and/or their interpretation. As an example, you could ask what, exactly, is the purpose of manual cell count controls? Should you perform QC on the counter/clicker, the microscope, the slide, and the pipette? Must only the staff member performing the QC for that shift do the actual counts?1 Inspectors should be able to defend the principles behind a question, and your concern for their reasoning, if done respectfully, should leave a favorable impression.

  6. Officially challenge a deficiency if you feel it is unjust. Personally, I did this only once, but we felt the challenge was justified because we believed the inspector misinterpreted the requirement and we eventually won that challenge. So, while it is important to keep in mind that you can question an inspector if you feel it is warranted and ask for a justification of the reasoning, it is also important to remain nonconfrontational. If an inspector seems intractable on a specific point, it is best to raise the concern formally after the inspection. This also allows time to build a case for your challenge.

  7. Ask if you can correct items while the inspector is there. A fair inspector may allow for on-site corrections to avoid a deficiency if the lab can do so before the end of the day, so it is always worth asking.

  8. Run a communication drill. This is to make sure your key employees are prepared for a telephone call or text message if they are off site when the inspectors arrive at the lab. I was late for one inspection at my lab due to a wrong number mixup, and this is an unnecessary complication that is completely avoidable with practice.

  9. Verify your policies are in use. If there is a policy that governs a practice in your lab, make sure that action is performed according to the policy and is documented, even if it is not a requirement of the inspection agency. If you say your blood-smear label has the patient birth date, make sure it does. If your actual practice is different, modify the policy or procedure to reflect that practice. This is especially true for anything related to a QC policy.

    Furthermore, if you have policies that are no longer practiced, remove them or risk being cited, even if the policy is not required by the checklist. Inspectors are unlikely to take issue with additional policies above the requirements, but whatever the policy, be sure it is supported by some type of documentation. It also may be helpful to keep a record of outdated or obsolete procedures with the date they were retired.

  10. Keep it neat. This is obvious, but the laboratory, management, technologists and technicians, and the documentation should be as presentable as possible. This action, as with the temperature logs, should be easy to comply with. After all, perception is part of an inspection. Even seemingly trivial things like new dividers and page covers in notebooks, new clipboards, and organized placement of instrument notes will help. Common courtesy and a willingness to accommodate are both beneficial to this process.

  11. Review phlebotomy in practice. Do not forget that inspectors may shadow a phlebotomist to review compliance. As a laboratory director or supervisor, observing phlebotomy draws is probably not part of your regular schedule, so it can be helpful to shadow one or more phlebotomists (with advanced notice, as a courtesy) to ensure this important practice area is also following proper protocols. Further, consider providing a small token of appreciation to the phlebotomist that accommodates an inspector (or any staff member doing so).

  12. Prepare for the post-inspection follow up. The total inspection process is not technically over until all necessary paperwork has been filed. This requires a meticulous explanation and correction for any citations during the inspection, using the format specified by the agency. This is also a vital, albeit sometimes challenging aspect of the overall process, as satisfaction must be gained both externally (the inspection agency in question) and internally (institutional administration). Ultimately, you need to ensure that the solution being offered to remedy a deficiency is actionable, proper, and practical for your lab. Going through this process can serve as motivation to improve for the next inspection.

  13. Perform a mock inspection. In my experience, mock inspections were rare and somewhat threadbare, yet they can be highly effective in preparing yourself, your staff, and your lab for the eventuality of an inspection. It also helps alleviate anxiety to slowly roll out this process. Over a period of several weeks leading up to the inspection, begin asking staff various questions related to the agency’s inspection list. Take an extra review of blood draws, temperature logs, QC records, and other documents to ensure uniformity and preparedness. Spending just 30 minutes a day for a few weeks leading up to the inspection should let you know if you are in good standing and should highlight any red flags.

Conclusion

Fortunately, inspection questions tend to focus on similar areas from visit to visit, so the process should get progressively easier for everyone involved. Accomplishing a lab inspection can be a great relief, no matter how well you do. As always, try to take the viewpoint that these activities should serve as opportunities to improve, which all laboratories are subject to. Every lab is unique, so the tips herein should serve as a rough guide for your own, custom approach to inspection. That said, all will benefit from an early start, and a strong finish can turn the lab inspection process into an event to anticipate, accomplish as a team, and be proud of.


Reference

  1. Midyett R. “Empty QC”: when QC is out of control. MLO Med Lab Obs. 2012;44(11):22,24,26. 

Roy Midyett, MT(ASCP), recently retired from PIH Health Hospital in Whittier, California, where he served as supervisor of hematology, coagulation, and urinalysis.
 
 

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