Is it OK to perform POCT without an order in public health?

[Nurse Beth, MSN]

I understand your concerns about moving from a hospital environment to a public health setting where the procedures seem less formal. Navigating these changes with the proper knowledge about POCT (Point-of-Care Testing) and regulatory frameworks like CLIA (Clinical Laboratory Improvement Amendments) is essential.

Below are some key points that may address your concerns:

CLIA Certification and POCT

Firstly, having a CLIA certificate is crucial for conducting any laboratory testing, including POCT, irrespective of the setting. CLIA certificates are required to ensure the laboratory meets quality standards for patient safety and accurate healthcare outcomes.

Under CLIA, there are waived tests that are considered simple and carry a low risk of incorrect results. These can include tests like urine pregnancy tests or blood glucose monitoring and are categorized based on their complexity—waived being the simplest form of testing that can be performed in varied settings, including a conference room, as long as the facility holds a valid CLIA certificate.

Find out the certificate holder —a lab director, medical director, or possibly a medical technologist. That person should be able to point you to the applicable policies.

You need to inquire about POCT policies in your organization and check your job description for related instructions. If you didn't receive any information during orientation, talk to your supervisor to learn more about the process.

Regulatory Considerations 

Regarding the need for a doctor's order, CLIA regulations permit Direct Access Testing (DAT), allowing patients to perform tests by certified laboratories without a physician's order. Some states permit DAT, while others have limitations.

This critical factor makes performing POCT on employees in a non-hospital setting, like a conference room, feasible and compliant, assuming all other quality and safety protocols are observed.

Safety and Competency

It's still essential to ensure the safety and accuracy of POCT  even outside the traditional lab environment.

This includes obtaining informed consent from those being tested, ensuring proper infection control measures, and having competent personnel conducting the tests. Non-laboratory trained individuals can perform POCT; however, appropriate training and competency must be ensured for accurate results and safety.

Best Practices

• Informed consent. Obtaining consent from employees before conducting the tests is a must.
• Infection control. Implementing standard infection control measures to protect both the personnel conducting the tests and the employees being tested.
• Competency of personnel. It's important that you demonstrate competency, maintain competency, and that your training is documented.
• Quality control of devices to assure reliability and accuracy.

Conclusion

While transitioning from a hospital setting to conducting POCT in a public domain, like a conference room, might initially seem daunting, adhering to CLIA regulations and ensuring proper training and safety protocols can make this a viable practice.

Best wishes,

Nurse Beth