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Mastering Clinical Laboratory Inspections: A Comprehensive Preparation Guide

Author: Darryl E. Elzie, PsyD, MHA, MT(ASCP), CQA (ASQ)

Clinical Laboratory Inspection Preparation

In the United States, seven accrediting organizations are approved by CLIA to accredit laboratories performing patient testing.  As part of the accreditation process, a laboratory must be inspected initially and then every two years. For laboratories, inspections are one of the most regularly occurring stress-inducing events they will experience. However, there are some things labs can do in preparation that will lessen the evitable stress of the required inspection.

Pre-inspection Preparation

Laboratories should always strive to be inspection-ready, but even the most well-run laboratory needs to do some things to prepare for an inspection. Here are a few of the small tasks that can go a long way in reducing inspection-related stress:

1.  Prepare a call-tree. A call-tree is a list of people to be contacted when the inspection team arrives. Share the list with the organization’s front desk or wherever the team will present itself. 

2.  Have a room reserved large enough for the inspectors to work undisturbed. (Having water available is always appreciated.)

3.  If the laboratory has an electronic document control system, create a process for the inspectors to view documents online. Some laboratories set up dedicated personal computers or laptops with sign-on specific for the inspectors. Other laboratories will assign personnel with computer access to each inspector. However, if the laboratory uses a paper document control system, see the note in number 4 below.

4.  Have a cart ready. All proficiency surveys performed since the last inspection are required to be reviewed. If survey results and evaluations are kept in books, they will need transportation to the room where the team is located. (Note: Paper procedure manuals, QC logs, and worksheets will also need reviewing, but if used in a testing area, they should not be in the inspection team’s clean location.)  

Other things not to forget:

Regulatory Requirements: Ensure familiarity with the specific regulations for your lab as determined by the inspection agency (e.g., CLIA certification). Review the requirements based on test menu complexity, specialties, instrumentation, and use of external reference labs.

Personnel Qualifications: Maintain complete documentation for all staff, including education, experience, training records, and competency assessments. Ensure all positions are filled by qualified personnel according to your job descriptions.  Expect all folders of individuals hired since the last inspection to be reviewed. Make sure the two six-month competencies are completed as required on applicable new employees. Remember, competency is the most frequently cited deficiency reported by all accrediting agencies.

Quality Control (QC) Records: Have readily available QC records, including calibration certificates, maintenance logs, function checks for current and discontinued instruments, temperature and humidity logs, and graphical representations of QC data. 

Test Procedures: Ensure test requisitions and report forms used for all testing are up-to-date. The inspectors may request to review patient charts as well.  Be prepared for an inspector to ask to track a sample from beginning to end.

Incident Management: Have a documented Incident Management Plan and document any past incidents and corrective actions.  

Quality Assessment (QA) Plan: Ensure your QA plan is up-to-date and document the plan’s implementation through QA reviews.  Check that IQCPs have addressed all required elements and have been reviewed as required.  Ensure root cause analyses are performed on identified problems as needed.

Review deficiencies received in the last inspection and verify that all have been corrected. Inspectors are tasked to check if the deficiencies or nonconformances of the previous inspections have been fixed and if corrective actions are being maintained. (Note: there will be no deficiencies to review if this is an initial inspection.)

Laboratory Organization and Environment:

Expired Materials: Conduct a thorough check and discard any expired reagents, quality control materials, or timers.  Inspectors call this “low-hanging deficiency fruit.”  Check all refrigerators and freezers for expired products.

Safety Equipment: Verify that all necessary safety equipment, like lab coats, gloves, and eyewash stations, are readily available and in good condition.  Ensure all fire extinguishers are checked.

Staff preparation

Laboratory staff is a critical part of laboratory operations. Accrediting organizations recognize this fact and task inspectors to ask staff questions to ensure they know the policies and procedures forming the framework of laboratory operations.

Lab directors and managers should make sure that staff is ready for inspectors’ questions about quality control, policies, and procedures (especially those involving critical values) and how they are involved in quality management. Some examples of questions are: what happens when an unacceptable specimen is received, and what identifiers are used to identify a sample?

It would be worthwhile to have staff review policies and procedures to confirm they are comfortable recalling information. 

Senior or lead techs are often heavily involved in answering questions from inspectors. They should be prepared to provide information on the proficiency testing process and quality control. Before the inspection, a review of all quality control and manual logs from the previous two years should be completed to ensure explanations or corrective actions for any out-of-control results or blank logs.

Wear PPE

Some may think it doesn’t need to be said. Still, lab managers and senior personnel should be diligent and remind all staff to wear the appropriate personal protective equipment (PPE) during the inspection. Staff not wearing PPE is another one of those low-hanging deficiencies mentioned earlier.

Conclusion

Many Inspections are unannounced (unless it’s an initial inspection), and having a call tree, a large room reserved, and a sizable cart ready are some of the small things that make a difference in smoothing out the inspection process.  

A well-prepared lab need not feel overwhelmed on inspection day. Though there is always a bit of stress accompanying any inspection, having the small things ready or reviewed goes a long way toward reducing stress and avoiding deficiencies or nonconformances.

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