If you have been asked to take on management of a blood gas lab for the first time, you are no doubt immersing yourself in the ins and outs of the process. With more than 20 years of experience running blood gas labs, long-time AARC member Jeffrey Haynes, RRT, RPFT, FAARC, has a wealth of experience to share. He answers your biggest questions in this interview —
We know there are moderate complexity labs and high complexity labs. What is the difference between the two?
The Food and Drug Administration assigns diagnostic tests a Clinical Laboratory Improvement Amendments (CLIA) complexity categorization based on seven criteria. Each component is assigned a score of 1, 2, or 3, where a score of 1 is the least complex and 3 is the most complex. A test with a cumulative score >12 is assigned to the high complexity status. Here are the seven criteria —
Knowledge: A low score is assigned if minimal scientific and technical knowledge is required to perform the test, so laboratory personnel do not require formal academic training. A high score is assigned if specialized scientific and technical knowledge is required to perform testing.
Training and experience: A low score is assigned if the test can be performed with minimal training and experience, whereas a high score is assigned to tests that require specialized training and greater experience.
Reagents and materials preparation: A low score is assigned to materials that are stable and require no preparation or specialized handling, whereas a high score is assigned to materials that require specific preparation and handling.
Characterization of operational steps: A low score is assigned to tests with automated operational steps, whereas a higher score is assigned if specific operational steps are required to perform the test correctly.
Calibration, quality control (QC), and proficiency testing materials: A low score is assigned if calibration, QC, and proficiency materials are stable and easily accessible.
Test system troubleshooting and equipment maintenance: A higher score is assigned if troubleshooting of the device is complex and maintenance requires specialized knowledge and skills.
Interpretation and judgement: A lower score is assigned when minimal interpretation and judgment are required to perform the test and resolve problems.
What qualifications must an RT have to work in this setting?
For both moderate complexity and high complexity testing, a respiratory therapist needs an associate’s degree or higher to perform blood gas testing. CLIA defines the qualifications and responsibilities of leadership positions in a laboratory as well, so it is important to ensure that personnel are eligible to serve in these specific roles. A respiratory therapist with an associate’s degree related to pulmonary function or laboratory medicine can function as a general supervisor, but a bachelor’s degree or higher is required to serve as a technical supervisor or technical consultant.
What is involved in setting up and managing an efficient blood gas lab, and why do you believe these are the most important components of the process?
Laboratory process should be divided into the pre-test, testing, and post-test phases. Pre-test processes include clinician preparation and training, equipment maintenance, quality control, and managing physician orders. The testing phase includes patient identification, order verification, and obtaining, handling, and analyzing the sample. Post-test processes include interpretation and reporting of the data and ensuring patient and provider satisfaction. My philosophy has always been that every step in the process is as important as any other.
How can the manager maintain competency for those who work in the lab?
Accrediting organizations require that laboratories perform an initial competency assessment for new employees, which is repeated six months after hire. For existing employees, yearly competency assessments are required. There are specific components that need to be included in the competency assessment tool, so it’s important to ensure that the competency tool includes all of the CLIA-required components.
In my laboratory I had our staff take a general laboratory knowledge test to assess knowledge. Following the test, education was provided, and six months later the test was re-administered to assess retention. Topics with low retention were incorporated into yearly education.
How do you deal with accreditation of the lab?
Firstly, it is important to have the right mindset. Accreditation is all about ensuring accurate testing and patient safety; it’s not about inspectors coming to make you look bad. The inspection team’s recommendations make your laboratory better, so don’t fear it, embrace it.
It is also important to have realistic expectations. Getting a perfect review with no improvement recommendations is unlikely. Do your best to prepare, but if deficiencies are identified know that this is an opportunity to make your laboratory better, learn something new, and come out of the accreditation process as a better laboratory manager than when you entered it.
In my own experience I have found two things vital to a successful accreditation inspection: start early and use checklists. Putting things off, procrastinating, then rushing to get everything completed before the inspection date leads to anxiety, oversights, and mistakes. Checklists help to reduce oversights and can make you feel confident that everything has been addressed. There are companies that provide software or web-based checklists to ensure that all CLIA regulations are being met.
What are the biggest challenges faced by blood gas lab managers and how can they overcome them?
The biggest challenge in running a blood gas laboratory is to create an environment in which respiratory therapists embrace removing their RT hat and donning a laboratory scientist hat when entering the laboratory. It is important for RTs to have a laboratory medicine mindset when working in the laboratory. One needs to act carefully and deliberately in a laboratory setting to avoid mistakes. The laboratory staff must practice with discipline — there can be no corner-cutting or circumventing of rules and procedures. As a manager, you must set the standards according to local and CLIA regulations and be prepared to enforce them, because what you permit, you promote.
What are your top 3-4 tips for RTs who are charged with managing a blood gas lab?
- Manage your laboratory everyday like you’re being inspected tomorrow.
- Create an environment in which your RTs take on a laboratory scientist mindset.
- Use checklists and schedules to prevent oversights.
- Always strive to be better; quality improvement is an open-ended process.
Jeff Haynes is currently the clinical coordinator of the pulmonary function laboratory at Elliot Health System in Manchester, NH. In addition to serving as a member of the Respiratory Care Journal Editorial Board, he is an associate editor of the Canadian Journal of Respiratory Therapy. He is also a member of the NBRC Board of Directors and serves as the vice chair of the NBRC Pulmonary Function Examination Committee. He was recently appointed to the Executive Committee of the Global Lung Function Initiative.
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