Guest Column | December 8, 2017

Quality Management System: Why It Matters And Its Impact On Patient Outcomes

By Richard Ellerie, quality management expert at Cantata Health

rare disease, patient voice

Our industry has begun to initiate another important phase in patient healthcare. The HITECH Act outlined the intended plans for the adoption of electronic health records through meaningful use. The Centers for Medicare and Medicaid Services’ (CMS) EHR Incentive programs have evolved into three stages of “Meaningful Use” with their own goals, priorities, and their own final rule. The last stage of the CMS Meaningful Use program, Stage 3, is on track to commence January 1, 2018. During this final phase the Quality Management System (QMS) specification, which was optional in Stage 2, will become a requirement.

The QMS specification is often viewed as a rubber stamp for the government; a mere checklist item if you will. However, in reality, QMS has real value — reducing risk to the patient by making sure technology does what it is supposed to do. When risks are reduced, patient safety is increased and outcomes improved.

QMS Defined

QMS is a framework that is driven by policies and procedures and requires detailed documentation. The primary goal of QMS is to ensure products are created in a systematic predictable way that best meets the real needs of customers, enabling them to care for their patients. Products are designed and built to be effective with great attention given to patient safety.

In the case of health IT software, significant planning is required to bring new or updated software to the market. QMS follows software development throughout the entire product lifecycle including planning, execution, and auditing which makes sure everything goes as intended and the product is safe. Any changes made along the way are well documented to record modifications and revisions and provide details of the software’s evolution.

QMS processes include customer interaction during the development of software. Customers are involved early in the software design process to ensure the product fits their needs. As the software design matures, with new features and functions added along the way, customers continue to provide input into changes. Insights into how the software will be used by the customer in different situations are documented to ensure an optimal product design. Again, the software design must demonstrate the highest patient safety standards.

Internal reviews are another key component of the QMS process. Well-documented peer reviews are held to ensure accuracy is maintained in software specifications, coding, and quality assurance testing. As the product develops, additional documented meetings are held as engineering staff, product managers, and quality assurance analysts conduct product checks to make sure the software does everything it is intended to do. Checks and rechecks ensure the software is effective, high quality, and safe for the patient.

In addition to the software development life cycle discussed above, QMS policies and procedures also define personnel requirements. All parties involved in software design, engineering, quality assurance, and installation of the software have different requirements for education, experience, and training. These personnel requirements are defined to guide hiring practices and training to ensure the right people are in place to make the software a success for customers.

Formalizing Processes

Prior to the standards mandated by Meaningful Use regulations, most of the policies and procedures of QMS were already being done in one form or another. The QMS framework, and its association with the Meaningful Use programs, formalizes and elevates the importance of these efforts. The procedures required by QMS result in the achievement of quality software designed to consistently and safely meet the needs of customer as they care for their patients. The standardization demanded by QMS moves beyond good intentions to ensuring good practices.

Improving Patient Outcomes

The QMS component of the Meaningful Use standards has a great impact on patient outcomes. The attention to detail, customer input, and quality demanded by QMS should not be viewed as onerous requirements, but as a very practical framework to ensure software helps us treat patients efficiently and safely. A QMS is not merely an extensive checklist, but a complete set of steps that all have meaning and help to produce software that aids in the care of patients. The desire to help patients is why QMS is important.

The ultimate goal for healthcare providers is to help patients get well as fast as they can without complications. This means having high quality technology that successfully tracks, monitors and understands where the patient is in the healthcare cycle so that the best possible outcome is achieved. QMS plays a key role in the delivery of such technology by making sure the final product does the best possible job it can do to keep patients safe and healthy.