Regulatory Inspections: Are You Ready?

Part Two: The inspectors are here!

In last month’s post we reviewed the importance of being prepared for your regulatory inspections, as well as some tips for how to accomplish this task. This month we’ll focus on the inspection process itself – areas the inspectors may focus on, and how your preparation work last month will make the process go smoothly.

Once your formal inspection is underway, don’t panic. Based on all of your preparation work in the months prior, you should be organized and ready to answer any question the inspectors may have regarding your current procedures and policies. The focus of each inspection will vary based on the regulatory agency it is being performed by, but the following areas have a high likelihood of being reviewed.

Utilize a Patient Tracer.  One of the easiest ways to evaluate your laboratory processes from pre-analytical, through analytical phase, and finally the post-analytical phase is to utilize a patient tracer. Inspectors may pick a specific date or date range, and ask to see all associated documents for a particular test.

Pre-Analytic. Gather a copy of the test requisition indicating the patient information, ordering physician, and specific tests requested. Ensure your phlebotomy team knows where your policies related to patient identification and specimen collection are located, and ensure they are following the requirements within these procedures. Inspectors may ask to observe the phlebotomy collection process, so prepare your staff ahead of time to reduce the potential for nervousness.

Analytic. All records related to the testing of the sample will need to be produced. This includes the actual instrument print-out for the sample in question and/or worksheets used to document results, quality control records for the day of testing, instrument maintenance and calibration records, as well as the training and competency records for the technologist who performed the test that day. Training and competency assessment are two different tasks – ensure you have documentation to support both of these activities at the required intervals for the staff member in question. Depending upon the actual circumstances surrounding that particular sample, there may be additional documentation requested such as corrective action logs, critical call notification records, or confirmation testing records.

Post-Analytic. Inspectors will also need to review how your results are being documented and displayed on the patient charts. They will be focusing on accurate transcription of results including units of measure and reference ranges; the correct timing of sample collection, receipt in the lab, and result reporting times; in addition to all of the patient demographics properly being displayed. They may also ask to see a corrected report to see how clinicians are notified about any changes, so patient treatment can be adjusted accordingly in a timely manner.

Proficiency Testing (PT) Results. One of the common requirements of a laboratory accreditation program is the participation in a proficiency testing program for all regulated analytes. Since the intent of this program is to ensure accuracy in your patient testing results, inspectors will be focused on any unsuccessful PT surveys, and the root cause analysis you performed to investigate the occurrence. Was this an isolated and random error, or is there a systemic quality issue which caused the inaccurate result? Did you perform a look-back to confirm accuracy of patient results being reported between the time of PT analysis and when the laboratory was notified of the unsuccessful event? Were your preventive actions implemented and sustained, or are you still continuing to experience accuracy problems with your testing? Be sure to document all steps of your investigation, and have that documentation available to inspectors for review.

Quality Metrics. Laboratory directors have a responsibility to provide oversight of their laboratory’s quality program, and to ensure that medically reliable data is being generated. There are many ways to monitor the quality of your laboratory program, and you should be prepared to speak on your methods in use to the inspectors. Although labs are not expected to be perfect, there is a responsibility to monitor for issues and initiate appropriate corrective and preventive actions when they are identified. Ensure that your monthly performance improvement metrics are reviewed and signed by your laboratory director, and any metrics not meeting performance goals have documented corrective action initiatives. Metrics should be meaningful and demonstrate continuous monitoring and improvements within the laboratory.

Be Honest and Transparent. If an inspector asks for specific documentation which you do not have, be upfront and let them know. Trying to hide a problem or misdirect an inspector away from a problem area can result in even more citations as it creates an environment of mistrust. Inspections are an opportunity to identify and improve upon the weak points in your laboratory program, and the inspectors themselves can offer ideas and suggestions on better ways to meet certain requirements that you may be struggling with. Some regulations can be interpreted differently by different individuals – ensure that your staff can speak to your practices in use and explain to the inspectors how you are satisfying the requirements.

Coming up in part 3, we’ll discuss what to do next – how to address any issues identified during the inspection process, and how to keep the overall experience positive and beneficial to your staff.



-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.

One thought on “Regulatory Inspections: Are You Ready?”

  1. Thank you for a wonder full information. Some examples of quality metrics in microbiology laboratory testing are, TAT, any patient safety related issues due to error or delay in reporting, proficiency testing results etc. Some of these metrics are also dependent on pre analytical part, for which labs have little control.

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