An Interview with Stephanie Halliday, Laboratory Concepts:
Stephanie Halliday is responsible for all functions of the clinical laboratory at Hillcroft Medical Clinic. In addition, she worked as a Program Specialist for the Texas Department of State Health Services as an inspector/surveyor of CLIA certified labs where she reviewed accreditation and compliance status. She has also worked as a consultant assisting clinical labs in startup, initial inspections, and training on standard operating procedures.
What is the purpose of CLIA?
Laboratories must comply with the Clinical Laboratory Improvement Amendments of 1988 to ensure the reliability and precision of their patient’s test results.. CLIA requires all entities that perform even one test, including waived tests on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain federal requirements. If an entity performs tests for these purposes, it is considered to be a laboratory under CLIA and the entity must register with the CLIA program. All laboratories in the U.S. that perform testing on humans — approximately 260,000 laboratories nationwide — are generally subject to the CLIA laboratory testing regulations enforced by the Centers for Medicare & Medicaid Services (CMS).
What are the requirements for CLIA Certification?
In general, CLIA defines requirements for the people, processes, and documentation needed to ensure reliable lab test results, including the following areas:
- Lab employees education, experience, and training
- Test methods and procedural training and documentation
- Verification methods to ensure the quality, accuracy, and precision of test methods
- On-site supervision and consultation availability
- Proficiency training
- Quality control and assessment programs with corrective action process
Labs must be inspected every two years to maintain their CLIA certification.
How are labs keeping up with these requirements today?
Companies that are interested in starting a lab or maintaining their compliance with CLIA requirements often rely on expert consultants to help them interpret, put in place, and follow required practices and documentation to become certified. In this capacity, I work with many different businesses across a spectrum of different laboratories.
What are some of the specific CLIA requirements for temperature monitoring?
CLIA requires that any sample, reagent, equipment, or environment that has a recommended temperature range to ensure the safety and reliability of test results are monitored and verified daily. Labs are required to check temperatures from these key areas or refrigeration systems every day and keep a log that captures a timestamp, temperature reading, and name of the person checking. Any anomalies or temperature excursions outside of required ranges must be documented with reasons for the issue and corrective action taken.
What are some of the common pitfalls you’ve seen in the labs you’ve consulted with?
Some of the common errors I’ve seen with labs are:
- Failure to monitor and document temperatures every day (days are missing in the log)
- Failure to track the amount of time that the temperature has been outside proper limits
- Failure to retain their temperature logs for at least 2 years
- Failure to set the temperature specific temperature threshold limits for each item monitored, and instead rely on the vendor default settings
- Failure to verify that their sensors are accurate and properly calibrated annually.
How does an automated temperature monitoring system help?
Many labs that I work with still rely on staff to check and record temperatures manually. This can take up a lot of time and be error-prone. However, I also see a lot of “built-in” digital monitoring systems that can be problematic. They still require a staff member to check the temperatures – or an employee might have to disconnect the system from the freezer and manually download the data to a computer for capturing the log. Again, these processes can be time-consuming and error-prone.
WIth an automated, cloud-based system like Swift Sensors, I see the following major benefits:
- Efficiency – the time required to verify and record temperatures can be significant. With finding, training, and retaining your workforce becoming more challenging, this is a growing issue.
- Protect against loss from equipment failure – Businesses may have tens or hundreds of thousands of dollars in medicine, samples, or vaccines stored in refrigeration systems. If a system fails, they not only lose financially, but the damage to their reputation and customer trust can be significant as well.
- Smoother inspections – One of the first things an inspector will ask for is the temperature log. When the customer has trouble finding their temperature log, or has an incomplete or error-ridden log, it sets the tone for a difficult inspection. I like the automated logging from Swift because it guarantees that you have all the data and prevents any modification or tampering – creating a very solid, high-quality impression for the lab when presented to an inspector.