SEVEN STEPS TO ENSURE SUCCESSFUL LABORATORY INSPECTION

Clinical laboratories are regulated by CLIA. This federal oversight is intended to enforce quality standards that ensure accurate, reliable and timely delivery of laboratory results. According to CLIA regulations, this responsibility ultimately relies on the laboratory director. Therefore, it is imperative for physicians and pathologists who take on the responsibility of laboratory director to have a complete understanding of the CLIA standards. Unfortunately, many pathology residency programs lack in-depth laboratory management training, which results in pathologists completing their residency programs without acquiring sufficient knowledge in this critical area. In fact, the focus on laboratory management is usually geared to preparing the residents for board questions that, most of the time, address rare and out of touch situations that are detached from real life scenarios laboratory directors face every day.

Many pathologists are either uninterested in taking on directorship responsibilities or unaware of CLIA standards. Nonetheless, quality should never be a one-person initiative. The entire organization is required to buy in and commit to following the quality plan. Furthermore, the chance of success of any quality plan is much more enhanced when the plan originates from a collective effort with input from all members of the organization. This approach guarantees adherence to and continuous improvement of the quality plan.

Going through an inspection is a difficult process and requires a complement of various components that are not limited to the actual areas of the inspection, but extend into how the team conducts itself and communicates with the inspector or the inspection team.

Here we present steps that will ensure successful completion of inspections. These seven steps are divided into three steps prior to the inspection, three steps during the inspection and one step following the inspection:

• 1.) Prior to the Inspection: Effective Preparation

  Laboratories are inspected every two years. The best time to start preparing for CLIA is the day after the previous inspection. In other words, the lab staff must be in constant preparation mode. Quality is a continuous process. You establish the policy, train the team to follow it, monitor adherence to the policy, if needed modify the policy, train the team, and so on.

• 2.) Prior to the Inspection: Documentation

  Documentation is the only way to show that you performed an activity. If it is not documented, it didn’t happen. Documentation is not limited to documenting incidents or disciplinary actions. It should be expanded to cover every quality activity including, but not limited to, training, competency assessment, corrective actions, procedure deviations, instrument malfunctions, laboratory errors, revised reports, communicating critical results, proficiency testing, peer review, etc.

• 3.) Prior to the Inspection: Organization

  To ensure a smooth inspection, the lab must be organized and clean. This cannot be an activity limited to the few days before the inspection. Cleaning and organizing must be an ongoing process, and it must be everyone’s responsibility. Having a clean and organized work space will help presenting good first impression to the inspector.

• 4.) During the Inspection: Professionalism

  Everyone must adhere to the highest professional standards, which includes proper attire and proper conduct with each other and with the inspector. Professional representation of the organization is an obligation. When the laboratory leadership cultivates this professional standard, there will not be any concerns about an inspector walking through the laboratory and speaking with any member of the team.

• 5.) During the Inspection: Communication

  One of the most effective tools to pass an inspection is to establish a rapport with the inspector. The laboratory team, which is preferably headed by the laboratory director or the quality director, must possess proper communication skills. It is important to understand that questions asked during the inspection must be answered truthfully. When in doubt, consulting with the team is always better than guessing or giving an inaccurate answer. If you realize that one of your answers was inaccurate, do not hesitate to correct it. This transparency shows integrity and goes a long way with inspectors. Asking for clarification or requesting more time to gather information is acceptable.

• 6.) During the Inspection: Cooperative Attitude

  On many occasions, inspectors express opinions that you may not necessarily agree with. The attitude towards such opinions must be respectful and factual. It is acceptable to disagree especially if you can provide acceptable evidence to support your argument. However, it is unwise to be combative or disrespectful. Such attitude is counterproductive and will lead nowhere. When you start your inspection by welcoming the inspector to your lab and expressing your willingness to cooperate and listen to any feedback, this makes the process more cooperative. Showing a cooperative attitude and willingness to learn, guarantees a smooth inspection. If the inspector finds deficiencies, it would be a good idea to discuss with them your planned corrective actions and even ask for advice. Not doing so would be a wasted opportunity to get help. 

• 7.) Following the Inspection: Proper & Thorough Follow-Up

  A personal note thanking the inspector for their feedback and listing certain points that you found to be helpful, confirms the cooperative attitude that you showed during the inspection. If there were any deficiencies, address them thoroughly and provide documents of corrective actions and revised policies.