ISO 9000 & AUDITS WORLD CONFERENCE
Applying the ISO 9001 Standard to Healthcare Big Data
Presenter: Joseph Larach, Senior Manager Quality Engineering, Health Management Systems, Irving, TX, USA
Keywords: Quality, Big Data, Operational Excellence
ISO 9001 has a storied history from driving operational excellence through a certified standard of controls acceptable to the outside world. When the U.S. military set inspection standards needed to bid on contracts during the 1970s they forced the U.S. manufacturing world to change. The military realized that a standard needed to be set for American manufacturers to ensure a quality product. Over the previous two decades American manufacturers had become too lax on quality standards due to manufacturing booms where there was no competition abroad.
Today the ISO 9001 standard is a requirement to do business in most manufacturing industries to ensure a quality product, but can the ISO 9001 standard be applied to healthcare data companies? Yes. Traditionally there has been a lack of standard processes in the healthcare data space, similar to U.S. manufacturing in the 1950s and 1960s. Health Management Systems (HMS) realized that operational excellence is paramount to delivering a quality data product, so instead of waiting for the government or client to set the precedence of operational standard controls in the industry we have implemented processes that conform to the ISO 9001 standard. This is uncharted territory for many data companies, but everything in the standard is designed to apply to every company. With ISO certification HMS has now pivoted to concentrating on leveraging customer input to dictate our operations and help us to continue to improve. HMS has evolved from an operational nightmare to a best in class thought leader in the healthcare data space in 6 years. In essence HMS is a data company who uses countless algorithms and manual reviews to ensure that the right person pays for medical claims and those claims are billed correctly from providers to insurance carriers. We live and breathe data analytics. There was never a need for operational excellence at HMS because the stock price was skyrocketing and money would just show up despite our archaic processes. In the early 2010s HMS realized that they needed to evolve and most of our products were not scalable and we lacked knowledge of our inner workings by relying too much on tribal knowledge of an ageing workforce. Slowly we began hiring manufacturing process improvement individuals. We began running green belt and black belt level projects utilizing all of the tools in the traditional Lean Six Sigma tool belt and starting to document the current state process across our 20 plus product offerings. The manufacturing professionals understood the significance of the ISO standards and what it could do to our business if we were able to have controls in place to ensure a quality product. No one in our sector of industry had become ISO 9001 certified yet, nor was it a requirement for any of our clients. At this point HMS was not ready to apply for an ISO certification, but we leveraged the standard to help us drive operational excellence and we march towards becoming the first company in our niche sector of the healthcare industry to become ISO 9001 certified. Over the next 4 years we began setting documented standards, SOPs, and re- engineering processes until we had control and understanding of our operations, and most importantly established an impartial quality department that did not report to operations. Client complaints went down, our market share continued to rise, but we were still missing enterprise standards between our products. We began enhancing our breadth of what quality means from instead of checking what operations does we checked the fit form and function of the product to conform with client requirements. That still didn’t make us best in class, we still had a gap of what we thought the client wanted vs what they actually wanted or more importantly needed, to get the most out of our products. We worked closely with our clients and showed them how to better leverage our data, while ensuring that our products delivered what they expected. We truly embraced our clients input to ensure our operations could support all of their needs and desires. Today the voice of the customer drives our entire business, from how we approach quality assurance and drive continuous improvements to our operations to ensure client satisfaction. As of October 2018 HMS is now officially ISO 9001 certified, because we used the standard to impose controls and understanding of our operations. ISO to us is not just a paper that says we’re certified to show off to clients, but it helped stand up and drive our core operations to ensure operational excellence. Our presentation will explain the unique world of healthcare big data and how the ISO 9001 standard helped drive operational excellence and continuous improvement to provide the best quality data auditing product in the healthcare market.