In this article:
- Make the most of the space you have
- How to find and train the best personnel
- Work closely and communicate with doctors to find success
Location: Columbus, Ohio
Opened: October 2008
Staff size: 55 employees (49 full-time employees includes one director, one associate director, one lab manager, six supervisors, and six part-time employees)
Main focus: Microbiology services and infectious disease testing
Test volume: 2010 - 2011 Molecular tests: 65,219; Clinical Microbiology overall: 281,123
Patient community: Tertiary care medical center
System size: 1,240 bed, three-hospital system
Current test menu: CMV (Quantitative), EBV (Quantitative), BK (Quantitative), HCV (Quantitative), HCV genotyping, HBV (Quantitative), HIV (Quantitative); Chlamydia and Gonorrhea (Qualitative); M.tuberculosis (Qualitative); Respiratory virus panel (12 viruses; qualitative); Influenza A/influenza B/RSV (Qualititative); Bacteria sequencing; mycobacteria sequencing; MRSA/SA (blood cultures); MRSA (nasal swab), C.difficile (Qualitative)
Interview with Dr. Preeti Pancholi
What kind of space did you have to work with when planning your molecular lab?
“We knew building out the molecular lab would take some time since the intended space was not immediately available. We started out by freeing up a lab storage area, 400- to 600-square-foot space in proximity to the diagnostic lab and were able to make it work with makeshift tables and instrumentation to get ourselves started. I also oversaw molecular operations 7 miles away to coordinate the effort and direct the staff. It took almost two years to open the new molecular diagnostic laboratory in proximity to our other microbiology diagnostic operations.”
Did you have experience in a molecular lab setting before starting this project?
“I was in a CPEP-approved fellowship training program in clinical microbiology at the Mayo Clinic in Rochester, Minn. It was a state-of-the-art facility with an entire floor dedicated to molecular diagnostic tests. Mayo Clinic was a great training ground for me especially in terms of how the tests and laboratory should be set up. I had five years of experience as the associate director of the Clinical Microbiology and Molecular Diagnostics laboratory at Columbia Presbyterian Medical Center in New York. I jump-started the molecular operations and implemented viral load assays. It was a great experience since all non-FDA test protocols had to be approved by the New York State Department of Health. Although I had never built a lab from an empty vacant room space, I had a good feel for how to separate different areas, keep a clean work environment, maintain workflow, etc. More importantly, I learned to be innovative and to be able to make the most of what is available.”
Who did you turn to for help when planning your molecular lab?
“I visited a few national laboratories and also the Ohio State Department of Health that had just moved into a new facility to see the design of their labs. It was important to note that workflow was apparent in the choices of test menus. My husband, Vijay Pancholi, is a faculty member at the Ohio State University Medical Center and has a well-established Bacterial Pathogenesis Laboratory. He was a great resource. Together, we designed and drew up blueprints to be most efficient with the envisioned work load and workflow. I presented the modular floor design to the planning committee members, including my medical and administrative directors, and subsequently moved forward with discussions with the hospital administrators, architects, safety officer, and infection control personnel for the final implementation of the proposed plan. The latter step was extremely crucial for the feasibility and the execution of the plan.”
What obstacles did you face when setting up your molecular lab?
“The biggest obstacles were the space constraints, budget and hiring trained personnel. The allocated lab space needs to support the growing test menu. The cost to the hospital was the major question and of primary concern. We decided on reagent rental (lease option) as a means to get started without having to come up with large sums of money for expensive capital purchase of lab equipment. Also, with the rapidly evolving field of molecular diagnostics, we wanted to stay current. Finding molecular savvy personnel is a huge obstacle as well. We wanted lab personnel who are well-trained in molecular diagnostics. Since many tests had never been implemented before, most lab personnel had to be trained to reach to the expected learning curve. Fortunately we were able to identify personnel with meticulous technical skills within the existing staff and they were very interested in training in molecular. Several of our staff members are now cross-trained. I found that the training for molecular techniques demands time, patience and resources to meet varying learning curves. But I found that everyone reaches the destination sooner or later.”
What ongoing challenges do you encounter in the molecular lab?
“Our ongoing challenges are keeping up with emerging technology, test development, drug treatments that impact the clinical tests, and test demands. We invest time and energy to look at new emerging technology and get involved in clinical trials. This gives our staff the opportunity to evaluate new test systems. It is important to keep people motivated and engaged.”
“Another ongoing challenge is billing and CPT codes. It is important to get paid and have tests you can bill. It is a complex process, so you need people who are knowledgeable with CPT codes to help. Personnel from Lab Information Systems (LIS) help us prepare to build billing code and interface with other required hospital/patient information. Our compliance officers keep us all at par with the institutional-stipulated guidelines to correctly implement billing procedures.”
What advice do you have for lab directors just starting a molecular lab?
“If you are thinking of a molecular operation, you need to know your work environment (e.g. community vs. academic or commercial), expectations and patient population. I would suggest taking a good look at the existing test menu, and deciding what tests might be useful to bring in-house or to be outsourced. Since the community and academic hospitals have different needs, the lab director would need to maintain strong communications with their medical director and clinicians or end users of the tests and be ready to answer questions including:
1. Does it makes sense to offer the tests in house (both from a financial and patient care point of view)
2. What kind of lab investments (e.g. manpower, space, expertise) would be required
3. Is the test to be implemented an FDA-cleared test or would it require extensive validation?
"In an academic setting, such as my medical center, I have found engaging in open discussions with end-users of the test (i.e. infectious disease and transplant physicians, infection control, and pharmacists) to be useful to envisage the impact of bringing new tests in house for timely appropriate interventions. These individuals can also be your advocate and provide impetus for bringing the test in-house. Such topics of discussion with your own lab LIS would ensure that the tests results interface well and are easily understood. In nutshell, patience, persistence, perseverance and engagement of others would provide good patient care.”
How do you measure the success of your lab?
“I see success of our lab in several ways. I have consistently witnessed that our test menu and our test volume have been growing every since the inception of our molecular microbiology laboratory. I have observed that once the physicians have gotten used to utilizing our offered tests, the volume have grown steadily. With in-house tests and weekly monitoring of viral loads, the physicians have been able to keep a better tabulation on patient outcomes, and more closely scrutinize their clinical conditions. We now have quicker answers for a number of infectious organisms in clinical specimens. For example, we now know early on if we are dealing with a methicillin-resistant staphylococcal infection or if someone has tuberculosis. We can create a more effective antimicrobial stewardship and infection control process and can be more judicious with the use of antimicrobials. All of this has contributed to a reduced length of stay, better clinical outcomes, and improved therapy. The criteria for success are being able to say that we made a difference.”