What was the biggest hurdle you faced in getting the UnitedHealth Group Brasil Institutional Laboratory up and running? How did you face that challenge?
The unknown was the greatest challenge we faced while setting up the Institutional Molecular Biology Lab at UnitedHealth Group. Besides, there was a shift in the paradigm for implementation standards in this field driven by the pandemic.
Learning more about the disease and how it would affect the population was crucial to determining the optimal approach to project development. We had a tight deadline to develop a complex lab. Our plan had to include the space, the infrastructure, the equipment, and the methodology. In addition, we had to hire qualified professionals, organize the logistics for sample transportation, and have exam requests and approvals set up electronically.
Consequently, in order to overcome these challenges, we needed to have a disruptive mindset and be creative to find immediate solutions to every single obstacle without adversely impacting patient safety.
With successful implementation of the laboratory requiring incredible alignment across teams, leaders and external partners, what strategic efforts became crucial to the management process?
In order to set up this lab successfully, our strategy after the project development phase was to determine the important points of execution. We hired three experts in diagnostic medicine who had the knowledge and autonomy required to resolve issues in three crucial areas. The first area addressed infrastructure, equipment, logistics, and IT. The second area included internal processes taking place before and after sample analysis. The third area covered the sample analysis process itself. These three experts met on a regular basis to set priorities and coordinate all tasks. These leaders also coordinated meetings with supporting teams in their respective areas, as well as with our third-party partners. These experts were also in charge of hiring qualified staff in each area. As the staff was hired, clear and objective tasks were set up and communicated to employees, so that they could participate in the decision-making and problem-solving steps.
Understanding the focus must remain on a high standard of patient care, while balancing the pressures of an emergent situation, how were you able to ensure quality control through this process?
Labs in the United States must be certified by CLIA (Clinical Laboratory Improvement Amendments) to comply with existing standards and yield reliable diagnostics. In Brazil, we don't have this kind of certification. However, there are national and international guidelines in place for molecular testing, and all of them were followed. Additionally, we followed specific national norms regarding laboratory infrastructure, which include the space that must be dedicated to each lab activity in order to ensure process efficiency and employee safety. Some considerations were crucial to establish a quality control process, including:
- The physical layout of the lab was taken into consideration to prevent contamination and false positives.
- The strategy to develop a quality test to detect SARS-CoV-2 in real time by PCR was to use assays approved by Anvisa, the Brazilian Health Surveillance Agency, and the FDA. A very detailed validation was performed with several positive and negative cases. Additionally, after this validation step, the Brazilian Department of Health verified the compliance of the tests performed at our lab and approved us to open to the public.
- Since a pre-analysis is crucial to obtain accurate results, we trained health workers in-person on how to collect samples early on, when testing was first implemented, and then developed some distance learning materials that were made available to retrain employees,
- In order to ensure high-quality testing, all processes were standardized and recorded, from filling in the request form to submitting test results. All lab activities have been documented through Work Instructions or Standard Operating Procedures.
From the beginning stages of planning the laboratory to the end result, did the achievements of daily testing and turnaround time exceed expectations or was this in line with initial goals?
During the lab planning phase, our goal was to conduct 600 tests a day for the patients with suspected SARS-CoV-2 seen at our hospitals. At the onset of operations, we were able to process 100 to 200 tests a day. We were able to gradually increase our capacity as planned, until we reached 600 tests a day. However, the number of requests started to increase as well and, in order to keep our turnaround time at 12-24 hours and avoid acquiring new equipment, we started to operate 24/7. This strategy allowed us to increase our capacity to 1,200 tests a day, which is where we are at now. However, since Brazil is going through a second wave, more requests are coming in every day and, in order to address this high demand, we will ultimately have to acquire new equipment to perform sample extraction and virus detection. One of the biggest challenges now is accurately estimating the demand. Before the second wave, we believed test requests would stabilize or even start to decrease. Scaling is no easy task, because it depends on so many variables. The unknown has played a relevant role in this scenario.
Thirty days from planning to implementation is certainly impressive. What lessons did you learn through this coordinated process that aided your success?
We were only able to set up a lab in record time and ensure quality due to the efforts and commitment of our team. It required clear strategy and a constant focus on our goal. Additionally, in order to achieve success in an initiative like this, we had to stick to a streamlined decision-making process that would lead to the efficient and effective execution of the project. In order to do so, we had to pay attention to market insights and be updated on scientific literature. Also, all decisions and actions must be clearly communicated, so there is no room for any misunderstanding. Transparency before all our stakeholders is paramount.
It was crucial that we put together a team of people who are in sync and have a similar mindset, albeit acting in their own unique ways, so as to ensure engagement and productivity. Establishing a clear, transparent partnership with suppliers also made us more aware of our decision-making process and allowed us to adapt to this ever-changing scenario as needed.
Dr. Renata Coudry is part of UnitedHealth Group Brasil, UnitedHealthcare Global's health care delivery and health benefits business in Brazil. Read her full article.