November 8, 2018

The Simplest Route to a CLIA Compliant Lab

The quality of care is imperative in maintaining high patient satisfaction scores and guaranteeing incentives. As a result, point-of-care testing…

The quality of care is imperative in maintaining high patient satisfaction scores and guaranteeing incentives. As a result, point-of-care testing (POCT) has become commonplace in outpatient and primary care as a means to improve clinical diagnosis and patient outcomes. However, maintaining a CLIA compliant lab does not come without challenges.

CLIA (the Clinical Lab Improvements Act of 1988) approves tests and sets criteria that practices must adhere to. Many tests are ‘waived’ and can be performed under Certificate of Waiver from CMS, whereas nonwaived testing is the term used to refer collectively to moderate and high complexity testing.

In our view, failure to comply with CLIA is worth avoiding at all costs as it should be seen as the promotion of best practice.

Your CLIA Compliant Lab

So what are the requirements for CLIA compliance?

Well, waived tests are simple, with a low risk of incorrect results. Practices perform many of these tests on a daily basis (i.e. urinalysis, A1C). However, this does not mean that they are entirely error-proof within your workflow, given the transcription errors that transpire from manual data entry. The problem is, they need to be error-proof.

A waiver may be obtained but that doesn’t mean performing labs can simply test and forget about CLIA compliance — CMS can inspect waived testing sites. Although not routinely done, this doesn’t mean they won’t! The big difference with nonwaived is you will be definitely be inspected.

CLIA requires that all equipment logs, maintenance records, QC documents, testing records, and test results should be kept for easy retrieval of information.

The person overseeing testing and operations (Practice Manager or POC Coordinator) must be equipped to assess test performance, identify and resolve potential problems affecting results, as well as maintaining patient and personnel information. Data must be correct, complete and easy to retrieve in order to avoid repercussions.

CLIA requires that patient test results are recorded in a log and kept as a permanent record. These records should have enough detail for easy retrieval of information at a future date. The question is, is this the case with your paper logs today?

Automated patient test results: keeping you compliant

AACC looked at the top laboratory deficiencies across accreditation agencies in a recent article. Following their inspections on the top 10 CLIA deficiencies, The Joint Commission stated ‘the laboratory report is complete and is in the patient’s clinical record’ was #3.

By using Relaymed, all automated patient test results are guaranteed to be digitally recorded and in the patient’s clinical record, instantly eliminating this deficiency. This also cuts out the manual labor and transcription errors that result from using paper printouts in your POCT process. Results are recorded automatically and are 100% accurate and complete.

This ensures that employee training is much easier than the manual alternative, by reducing procedural steps with all patient test results captured and recorded automatically from the device.

Occasionally, practices will look to the likes of a laboratory information system (LIS) to address these issues but they are overly complex and unaffordable for use in a primary care or outpatient setting. This is not what you need. All of the aforementioned criteria for a CLIA compliant lab, that can fall by the wayside in POCT workflows, are covered by Relaymed in one affordable and scalable package.

Quality Controls are important

Quality control (QC) procedures are often overlooked by sites, especially those conducting only waived testing. You should not let this happen. At a minimum, the device manufacturers instructions on QC procedures must be followed and a log of results kept.

COLA ranked a lack of QC logs at #5 in their Top 10 Deficiencies!

Regardless, these are exceptionally important for practices and CLIA alike, as they add confidence that your results are accurate and reliable. Otherwise, POC devices are vulnerable to a host of issues that can go unnoticed.

Relaymed captures QCs digitally and alerts users to problems such as reagent/test kit deterioration, equipment failure, environmental conditions, and human error. This goes a long way to ensuring your lab is working effectively but also protects your from potential reproval from CLIA. The same personnel who perform patient testing should also test controls with each new shipment of kits/reagents, changes to lot numbers and each new operator.

And, like everything with Relaymed, all of this information is tracked automatically. Importantly, it also offers remote visibility across an entire organization — no need to cross the country to review QCs! Patient records and QC logs can be reviewed on our web portal, myrelaymed, for all performing locations.

With this visibility, you can harness QC logs to learn from trends and patterns. Knowing which tests are working and being performed correctly will assist POC data management, helping you to identify problems and improve care.

Surely, it’s a no-brainer!

No more paper printouts, no more compliance risk — Relaymed is the POC data management solution that offers so much more. Compliance is so important but, thankfully, it’s now very easy.

Relaymed removes manual labor and errors from your point-of-care testing workflow. By onboarding with us, we will make a CLIA compliant lab fool-proof. This allows you to micromanage facilities without them noticing!

Find out more about how Relaymed can help your lab workflows, as well as the straightforward onboarding process and commitment to customer care.

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Further Reading

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