Regulatory Inspections: Are You Ready?

Part Three: The inspectors have left – now what?

In the previous 2 blog posts we discussed how to prepare for your inspection, and what to expect during the inspection itself. In the last of our 3 part series on regulatory inspection preparedness, today we’ll be covering what to do after the inspection ends.

Throughout the inspection itself, the inspectors should be communicating any issues or citations they uncover; ensure that your management staff is taking notes on any of these potential findings. Based on these notes, you should start working to address and correct any issues right away. Formal documentation regarding the nature of any official citations can take several weeks to receive back, depending upon the regulatory agency performing the inspection. Waiting for the formal report to begin making corrections will reduce the time you have to form a plan of correction, and can further impact patient care depending upon the citation received.

Have a Plan. Draft a spreadsheet to record: 1) each issue identified, 2) laboratory department(s) it was found in, 3) associated risk factor (patient care or safety issues = 1, regulatory requirements = 2, recommendations = 3), 4) staff member assigned to investigate and correct the issue, 5) due date for investigation response, and 6) status of the investigation (in progress, on hold, completed). Share this spreadsheet with your management team, and review at weekly/monthly staff meetings for updates on progress completion.

Risk 1 Issues. The safety of your patients and staff, along with ensuring accuracy in testing results is the number one priority of a laboratory. If the inspectors identified any weaknesses in these areas, they should be addressed first. This would include items such as staff not adhering to required safety precautions, not following manufacturer requirements for quality control testing or instrument maintenance/calibration, lack of follow-up for QC or proficiency testing failures, along with any other finding which questions the integrity and accuracy of the testing being performed.

Risk 2 Issues. Double check the regulatory standard to ensure you fully understand the requirements, and that you have appropriate evidence of compliance. As the testing activity menu and complexity of testing increases, the amount of documentation requirements can increase as well. Even with a paperless system, it is easy to overlook a signature of review or checkmark on a log. “If it’s not documented, it wasn’t done.” For simple administrative oversights, review your current processes to identify any gaps or areas that can be improved upon to ensure all documentation is properly filled out each month. If the inspectors noted a discrepancy between your current policy and how staff are actually performing a test, review the testing process to see where the true discrepancy is – is the policy outdated and needs to be revised, or do staff need to be retrained on the current policy with competency assessed for compliance?

Risk 3 Issues. Inspections are a great opportunity for further education for all those involved, both the inspector and staff being inspected as well. For some regulations, there is no one set way that must be followed in order to demonstrate compliance with a requirement. Hearing how someone else is meeting the requirements may spark an innovative idea from your own staff on how your current processes can be improved. Be open to hearing new ideas, and find ways to implement those which you feel would be successful at your institution.

Evaluate All Sections of the Lab. When investigating a finding in one laboratory department, ensure that any process improvements are shared across all areas of the lab. Just because microbiology didn’t get caught with expired reagents like hematology did this inspection, doesn’t mean that they aren’t at risk for future inspections.

Focus on the Positives. Congratulate and recognize your staff on their successes in the areas you performed exceptionally well in. It’s a joint effort to ensure the lab is inspection ready; be sure to pass along any compliments received throughout the inspection process to all levels of staffing. Focus on what you’re doing well and how you can continue to maintain those processes and implement them in additional areas.

A little bit of preparation ahead of time will make the inspection process smoother and less stressful for all involved. When viewed as a learning experience and opportunity for improvement rather than a visit from the “lab police”, laboratory inspections can be a useful tool to confirm the quality of your overall laboratory program.

 

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-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

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