Continual Improvement – A Quality Paradigm

The need for continued improvement in the quality systems of healthcare delivery organizations has been well documented. Quality professionals, whether practitioners, administrators, or service and products providers, must determine what is the most beneficial, proven, and cost-effective approach. Among today’s most popular quality programs and tools – Malcolm Baldrige, Six Sigma, and ISO 9001, which can enable results that match your goals? Such goals likely include:

• Reduced variation in work practices
• Clear standardized work instructions
• Enhanced intra- and inter- departmental communications
• Practical metrics that reflect progress
• Reduced operating costs
• Error prevention
• Reduced liability exposure
• Reduced cost
• Top management commitment and support

The Routes to Quality in Healthcare

Six Sigma has been met with much skepticism in the healthcare field. In manufacturing, it is possible to eliminate human variability through automation, creating precise measurement of assignable causes of variation. But the delivery of patient care is largely a human process, so the causes of variability are much harder to identify. The challenge becomes finding a way to leverage the data to drive human behavior. The most successful organizations have combined a strong technical strategy, like Six Sigma, with a strong cultural strategy to drive the change. It has been established in both hospitals and health systems as a tool to improve service levels, cost productivity and customer satisfaction.

The Malcolm Baldrige National Quality Award – given to organizations judged to be outstanding in seven areas: leadership; strategic planning; customer and market focus; measurement, analysis, and knowledge management; human resource focus; process management; and results – is becoming increasingly popular in the healthcare industry. Organizations of all types can effectively apply the Baldrige criteria. When done well, self-assessments can be used as a catalyst for change, and when joined with a focused improvement effort can result in remarkable performance levels.

ISO 9001 Ties it All Together

ISO 9001:2015 is an internationally developed and accepted set of quality system requirements.  These requirements form the foundation or system for on-going quality management.  Six Sigma and Baldridge (or TQM) can then become tools for continual improvement of the business processes.  There are over a half million organizations worldwide that have adopted ISO 9001 and this strategy for continual improvement.  Several success stories for ISO 9001 in healthcare follow.
A major hospital achieved the following benefits:

• decreased variation in work practices, treatment methods, and ways to organize services
• improved statistical follow-up on quality indicators
• implementation of clear work instructions and their standardization
• reduced patient contacts with the patient counselor
• largely positive attitude of personnel with regard to quality
• reduced number of compensation cases against treatment errors paid by national insurance
• improved information management via Intranet and Internet

An occupational medical facility reported closing 47.1% of workers compensation cases, reducing industrial rehabilitation cases below national averages, and eliminating redundancies resulting in substantial savings.

A large managed care company noted that ISO 9001 provided the following benefits:

• alignment with new “customer focused” approach
• provides external validation
• generic applicability and adaptability to evolving business models
• comprehensive – can be applied to all departments
• compatibility with other management frameworks
• improved efficiency and effectiveness
• improved performance and service quality

An ISO 9001 certified healthcare delivery organization reported improved profit, lower employee turnover, better than national performance average on benchmark indicators, and improved effectiveness and efficiency.

Healthcare Suppliers Turning to ISO 9001

Each day, healthcare delivery professionals are interfacing more with ISO certified healthcare related organizations. To name just a few in which ISO 9001 registration is prevalent: providers of medical devices, durable medical equipment, pharmaceuticals, therapeutic products, laboratory chemicals, medical gases, micro-electronics, steam sterilizers, electrooptical and laser systems, surgical instruments, repair and calibration of medical instruments, medical image processing, and program safeguard contractors. These customers and suppliers have focused on improving their existing quality systems, reducing their costs, improving communications, and reducing the risk of liability.

Why Implement ISO 9001 for Healthcare

ISO 9001 is well known and has been well accepted as a quality standard across many service and manufacturing industries throughout the USA. As a result, there are many resources available to assist with implementation, such as extensive literature, experienced quality managers, good consultants, and valuable training courses. SRI Training, to cite one, offers courses on how to Document, Interpret, and Implement ISO 9001:2015, as well as courses on Internal Auditing. A robust ISO 9001 compliant system will achieve broad industry and public recognition.

Benefits of ISO 9001 Registration

Implementing a healthcare quality management system registered to ISO 9001:2015 can lead to benefits such as:

• a demonstrated commitment to providers, patients, and stakeholders of strengthening “organizational capability”
• improved processes that result in reduction of errors and risk of liability
• increased satisfaction of patients, medical and clinical staff, and other healthcare participants
• an enhanced image of the organization through proactive quality focused leadership
• a recognized responsibility for, and involvement with, quality by the entire organization
• better defined processes and sub-processes, including their critical links
• recognition of deterrents to an operation’s or service’s efficiency and effectiveness
• identified opportunities for improvement
• a strengthened commitment toward the organization’s satisfaction of regulatory requirements
• improved communications among and between healthcare participants

It may not be readily apparent, but quality management systems registered to ISO 9001:2015 can be applied to address items such as: medical errors, credibility problems, medication administration issues, patient safety, and equipment up time. ISO 9001:2015 focuses on control processes which typically equate to costs in control and can lead to prevention or reduction of liability.

Choosing the Right Path to Quality Improvement

Six Sigma, Malcolm Baldrige, and ISO 9001 are all excellent ways to improve quality in your organization. To choose the right tool, you need to consider both your short and long term goals. For instance, with ISO 9001, the chances of maintaining your quality initiatives are greater, due to the process and system approach, and the use of annual or semi-annual surveillances of your quality management. There are many factors to take into account, and a decision should not be made lightly.