Every laboratory knows that they must participate in proficiency testing (PT) for all of the regulated analytes they report. But did you know that there is more to it than simply checking your overall score in each survey you participate in? Whether you utilize samples from the CAP, API, or have developed your own in-house blind sample testing algorithm, there is a lot of data available to help you assess the quality of your laboratory program. In the first of this 3-part series, we’ll review why PT testing is important and the rules that must be followed. In part 2 we’ll discuss how to properly perform an investigation when scores are <100%. Lastly, in part 3 we’ll look at how to review your results so that you get the most out of them for a successful quality laboratory.
Why participate? Well frankly, because you have to. It is a CLIA/CMS requirement, and if your lab has additional accreditations, those agencies will have their own rules and requirements as well (we’ll get to the rules in a little bit). But outside of the regulations stating you must participate; all labs should want to participate. It’s an opportunity to check your accuracy against peers who are using the same instrumentation as you. Similar to utilizing an affiliated QC report, this is a way to see what the “real” value is supposed to be (despite what a manufacturer may claim it to be), and how close/far off your lab is to that true value. It can help you identify potential problems before they become huge problems with patient values being affected, and it’s also a great way to satisfy competency requirements for your staff.
The rules:
- Participation: For every regulated analyte being tested under your laboratory permit1, you must participate in a CMS-approved PT program2.
Key things to note: This only applies to testing performed using non-waived methodologies. Waived testing is exempt from PT requirements; although it is still recommended that participation occur if an evaluation program is available. Additionally, this only applies to your primary instrumentation. For example, if you have an automated urinalysis reader and your backup methodology is to read dipsticks manually, you are only required to participate in PT for the primary methodology. (Your backup method would then be evaluated for accuracy through semi-annual correlation studies.)
- Routine Analysis: Unless otherwise instructed by the provider of your PT samples, PT samples are to be treated the same as patient samples. Meaning they are handled, prepared, processed, examined, tested and reported the same way you would perform patient testing; AND by the same staff who would handle patient testing.
Key things to note: If nursing staff perform a particular test within their unit (for example, ACT testing in the cardiac cath lab), it is those nursing staff members who must run the PT samples. You cannot have the laboratory perform PT testing unless the laboratory also performs the patient testing. Additionally, PT samples should be rotated among all staff members who perform patient testing. Meaning all shifts, and all days of the week that the test is performed – don’t let the day shift get all the fun.
- Repeated Analysis: Similar to rule #2, unless you routinely perform duplicate testing on your patient samples, you cannot perform duplicate or repeat testing on your PT samples. You cannot run a PT sample in duplicate “just to make sure.” Patient samples are just as important to be accurate as a PT sample, which is why we participate in a PT program in the first place.
Key things to note: After the date that laboratories are required to report results back to the PT provider, you are then allowed to use the samples for repeat testing. This can be used to check for uniformity in grading of reactions among staff members, and to assess annual competency. But only after the submission date has passed.
- Interlaboratory Communication: You cannot discuss the results or samples from a PT survey with any other laboratory (or Facebook user group) until after the results submission deadline has passed. Doing so before that time would be considered cheating. The point of PT testing is not to see how good your networking skills are, but to ensure accuracy of your own results. Plus, the other lab may not be as good as you think they are.
Key things to note: If your laboratory is part of a larger integrated health system, be careful that you have separate designated staff assigned to enter results from each location. Entering results for more than one permit number by the same person would be considered a violation of the interlaboratory communication rule as they could compare results from Lab A to Lab B prior to submitting. Also, be mindful of what you put on social media. User groups are a great networking resource and learning tool, but you still need to follow the rules. Violating them in a public arena such as Facebook for all the world to see would put yourself and your organization in great jeopardy if you were caught.
- Referral of Samples: You are not permitted to forward or share your PT samples with any other laboratory until after the result submission deadline has passed. Similarly, if your laboratory has received PT samples from another lab, state regulations may require you to notify your local Department of Health to inform them of the violation.
Key things to note: The intended purpose of performing PT testing is to verify the accuracy of your own laboratory testing. If you would routinely send a positive sample to a reference lab for additional confirmation testing, you would not do so in this case. Simply report out the values for the tests that your laboratory performs only. The reference laboratory will have their own PT samples to check accuracy for the confirmation testing they perform for you. Ensure your testing menu is up to date and accurate so that your PT provider is not expecting values for a confirmatory test if you do not physically perform it in-house.
- Records Retention: Ensure that all records and documents related to the testing of PT samples are saved for the amount of time required by your regulatory agencies (typically 2-5 years). This includes instrument print outs, LIS chart copies of the filed results, QC records for the day of testing, and any associated worksheets used to document your results.
Key things to note: Retaining a copy of the instrument maintenance logs and QC records along with the actual PT results will help you investigate any scores that are less than 100%.
- Attestation: Both the laboratory director and all personnel performing testing must sign the included attestation statement. This is not just a way to track who performed the test, but is a legal binding document assuring that testing was carried out appropriately as per the rules defined above.
The penalties for labs that are caught violating the rules (whether intentionally or not) can be quite severe. These penalties can include the revocation of your CLIA permit; a ban for the laboratory owner and laboratory director; as well as possible financial penalties and fines.
Coming up in the next blog we’ll review the rest of the rules related to evaluation of your scored PT results, and how to perform a thorough investigation into any unsuccessful survey events.
1: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliabrochure8.pdf
2: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ptlist.pdf
-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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