Passing a laboratory inspection is no easy feat. In preparing for a laboratory inspection, documentation is key. Documentation practices are often the backbone to an effective quality assurance (QA) plan. Laboratories often have standard operating procedures categorized in special document-control software to track the life cycle of the document, including reviewing, updating, printing, and eventually archiving. The same level of detail should also be used to document the proficiency testing (PT) process for the laboratory.
Proficiency testing, as defined by ISO 17043, is an evaluation of a participant’s performance against pre-established criteria by means of inter-laboratory comparisons.1
Documentation of proficiency testing results is often overlooked. With a little investment, a well thought out and controlled process can create great efficiency and help you and your team pass your next laboratory inspection. This documentation doesn’t just start and end with a signature on a final evaluation report. If we consider the PT process to be a cycle of events consisting of an enrollment, shipment, analysis, submission, report, review, and follow-up, a simple set of tools can be created to accurately document the entire process. Developing such tools includes having a clearly documented set of workflows, procedures, and checklists to help keep everyone in the lab equally informed and empowered throughout the enrollment, pre-analytic and post-analytic components of the proficiency testing process.
Enrollment
When preparing documentation for the enrollment component of proficiency testing, start by reviewing CLIA policy, as provided below:
CLIA 493.801(a) A laboratory must notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart, and the laboratory must designate a program to be used for each specialty, subspecialty, and analyte.2
This requirement can become especially complex, because there are some analytes that can appear in multiple programs with just one provider. This becomes infinitely more complex when you consider the number of providers available. Your workflow should include an identification of the analytes currently on your test menu, along with the designated proficiency testing provider and program name.
If there is more than one provider or program, make sure these are designated on a document for this workflow. All providers and programs with which your facility participates should be available and transparent to every individual performing the testing. Proficiency testing samples do not come with labels designating where they should be tested, so it becomes increasingly easy to assay and report the samples on the wrong instrument, leading to a potential failure. Save any confirmation documents from the proficiency testing provider, as laboratories may need to provide proof of enrollment if an accrediting agency has any question about your test menu. More importantly, review your menu every year as part of the enrollment process. The regulatory process can become very complicated if a lab manager realizes they failed to submit the enrollment form.
Most PT providers will include a list of scheduled dates for each shipment. Make a note as part of your workflow. A posted calendar in the lab with the dates outlined is one way to do this. Another idea is to create a PT checklist that shows everyone what date materials should arrive.
Pre-analytic
Once you have completed the enrollment process, shift your workflow to the actual events. A workflow should be designed with an eye toward the report review process. Try creating a checklist by working through an example scenario in which a failure appeared on a report. Then, determine what you would want to know in this simulated case. Think of the questions that would need to be answered at that time. When was the sample received? What was the condition of the sample at the time of receipt? How was it stored? Who performed the testing? Consider including a spot on the checklist for when the last time maintenance (scheduled or unscheduled) was performed on the instrument.
Incorporate information on the PT provider in the workflow and encourage staff to follow up with the provider if there are any package, sample, or analysis issues. Including the account information and the phone numbers for the PT providers involved in the testing gives staff members the information they need to facilitate the replacement of samples or get answers to questions as they arise during the event. This could save time for the lab and potential non-participation failures.
Have a spot in the workflow document to indicate if the sample required any special pre-treatment prior to analysis that was beyond what would be done for a patient.
Post-analytic
Create a post-analytical part of your workflow and document any information required for submitting results, including fax numbers or web portals necessary to complete data submission. Build in time for a review of all submitted data to ensure every analyte includes a result. Include steps for the attestation signatures by the analyst and director or director designee. Take time to analyze the results, comments, and narratives that the PT provider includes with the report. Check that your instrument, method, reagent, and reporting units match what the PT provider has currently listed on your account. Be sure to include copies of the instrument printouts with the documentation. Highlight failures and ungraded results, and investigate each situation using a standard QA process. Consider adding failed PT events to an adverse event follow-up process. The workflow document should end with the evaluation report review process.
Using a checklist that includes multiple components to promote review by all staff will make the PT process more transparent to everyone in the laboratory. In turn, a more transparent process will facilitate a smooth on-site inspection, allow a laboratory to track participation, and create a standard way of reviewing the evaluation reports. If you use a checklist, add the titles of all the people who need to review and sign the report prior to filing. If a failure includes follow-up at a staff meeting, consider saving the meeting minutes as part of the documentation.
Include a step to review patient data from the same day and add the PT sample analysis to serve as part of the corrective action in the workflow document. Have the checklist follow the samples, results, and eventually, the evaluation report. Build in pre-analytic, analytic, post-analytic, and report follow-up sections. Cover just the basics to make the checklist is quick and easy to follow. Use “yes/no” answers for each checklist item. Detailed quality-assurance information should be assessed only after the evaluation report has been reviewed, as the return on this investment of time becomes minimal if the report has no failures or ungraded results. Incorporate this checklist into your document control system and include references to any applicable proficiency testing procedures your lab might have.
Building a robust documentation process is an important way to prepare for laboratory inspections. When staff members have developed a system to document and communicate practices and procedures, labs are better equipped to handle an inspection at any time of the year. The proficiency testing process can be a very stressful experience generally for technical supervisors, bench staff, and managers. Having clearly understood workflows, procedures, and checklists can help alleviate some of this stress. Creating a transparent documentation procedure allows all members of your team to become involved in the proficiency testing process and creates a series of checks and balances. Furthermore, having staff equally informed and engaged in the documentation procedure helps keep everyone in the lab equally empowered throughout the enrollment, pre-analytic and post-analytic components of the PT process. Empowering lab staff means that lab managers are giving their staff members everything they need to have a successful inspection.
References
- ISO/IEC 17043 Conformity assessment –General requirements for proficiency testing. First Edition. ISO. February 1, 2010.
- Electronic code of federal regulations. Part 493. Laboratory requirements. U.S. Government Publishing Office. https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#sp42.5.493.a. Accessed March 3, 2021.
