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Safety Assurance: The Third Pillar of a Safety Management System

Editor’s note: Our Safety Leadership column is written by experts Michael Greene, Blair Bigham and Daniel Patterson. Following is part six of a 12-part series.

Have you given blood recently? You should, if just to visit a blood bank as part of your safety management system (SMS) program development. There you’ll find a shining example of processes that demonstrate all the elements of the third pillar of an SMS, assurance.

Blood banks practice meticulous and comprehensive data collection, analysis, assessment and review to ensure blood-product safety goals are achieved. And if you’ve gotten blood recently, you can be assured that the blood you received is safe. Just like in EMS, lives are at stake, and an error can have disastrous—if not fatal—consequences, so blood banks take assurance seriously.
To build the third pillar of your SMS, safety assurance, the organization must incorporate regular data collection, analysis, assessment and management review to ensure that safety goals are achieved. This pillar comprises three elements:

  • Safety performance management
  • Change management
  • Continual improvement

The time-tested management adage, you can’t manage what you don’t measure, applies to the base of the pillar. Under the second pillar, hazards are identified using the MEEPS acronym (materials, equipment, environment, people, systems), then precautions and controls are implemented. In this phase of an SMS, those hazard and control measures are going to be quantified and gauged to provide assurance that safety is being achieved.

Safety performance management consists of monitoring, audits, investigations, root cause analysis, employee reporting, data analysis, and preventive and corrective actions. While each of these elements could consume an entire issue of Best Practices, two deserve special emphasis here: monitoring and employee reporting.


Monitoring and employee reporting

Monitoring of your SMS requires a commitment on the part of leadership and staff that safety is first and foremost. It implies metrics; documentation; analysis; and regular, timely reporting. Monitoring requires transparency and constant communication on who, why, how, when, where and what is being monitored; a closed-loop process; and “top-of-mind awareness.” This level of monitoring, feedback and communication provides an answer to the question, How do you know you are safe? and the metrics to support the statement.

Employee reporting is absolutely critical to the success of an SMS. Remember the “Iceberg of Ignorance,” in which 100 percent of problems are known to the rank and file, yet only 4 percent to top management? Leadership must create a process for event or near-miss reporting to capture the 96 percent of the iceberg under the water.

I learned a painful yet profound lesson about employee reporting in the days and months that followed the tragedy that I opened this series with—a fatal helicopter crash at my service. Staff on the front line had experienced and talked among themselves about the tendency of the pilot to operate the aircraft differently than his peers. Behind the scene, leadership had been working on the aviator’s performance through feedback, training and regular auditing. Yet while leadership had a limited set of eyes on the performance, the staff continued to experience and discuss the behavior that may have contributed to this accident.

Leadership failed to “connect the dots” because we had not created a safe, timely and dynamic process or culture for employee reporting. Mind you, we had paper incident reporting and safety reviews, but the system was perceived as a “tattle-tale” practice with potentially punitive outcomes. This example takes us back to the point that an SMS must be built on a strong foundation of a safe and just culture. I encourage both an internal, non-punitive reporting system, as well as participation in state or national event reporting.

Internal and national event reporting

An internal reporting system serves multiple functions. It allows errors to become the design for system protections, it may provide an early warning of potential issues, and it gives leadership and safety managers the opportunity to connect the dots. It’s important to encourage and capture positive events as well, because you may discover a best practice applicable to the entire organization. For example, not so long ago, one staff member reported “the fastest turnaround time ever during a transfer!” because the communications specialist had requested a fax cover sheet and medical record when the call was requested. Safety issue, no—best practice, you bet! We captured and spread this best practice throughout the organization because we encouraged event reporting of the good, along with the bad and ugly.

State and national EMS event reporting systems have been designed around the process, and success, of NASA’s Aviation Safety Reporting System (ASRS). Founded in 1976, the ASRS was designed primarily to support the Federal Aviation Administration in its mission to eliminate unsafe conditions and prevent avoidable accidents in the national aviation system. The ASRS model has been emulated worldwide inside and outside aviation. In maritime, rail and highway transportation industries, as well as the Veterans Health Administration, safety reporting systems have been developed and implemented.

The EMS Voluntary Event Notification Tool (EVENT) is an anonymous, non-punitive and confidential system that has been developed to help improve the quality and reliability of care provided to patients by EMS personnel. Like ASRS in the aviation industry, the goal of EVENT is to improve the systems and processes of emergency medical care by identifying situations where a patient was potentially harmed, could possibly be harmed or when a close call occurred. Primarily designed to improve patient safety, the model allows the EMS industry to learn from our collective mistakes, errors and near misses.

Management of change

Solid change management processes ensure the system adapts to change while ensuring that the safety, health and environmental risks are controlled. Management of change is a structured approach to transitioning individuals, teams and organizations from a current state to a desired future state. It is an organizational process aimed at empowering employees to accept and embrace changes in their current business environment. A simplified model for change management is illustrated at right.

Without sounding cliché, change happens, and often, so it is imperative that as leaders we manage and welcome it. I can think of no better statement on change than said by the character Haw in Spencer Johnson’s fabulous book, Who Moved My Cheese? Haw’s “handwriting on the wall” said, “Be ready to change quickly and enjoy it again and again—they keep moving the cheese.”

Continuous improvement

The final element under the third pillar of SMS is continuous improvement (CI). CI is an ongoing effort to improve products, services or processes. Among the most widely used tools for CI is a four-step quality model—the plan-do-check-act cycle, also known as the Deming Cycle or Shewhart Cycle. Other widely used methods of continuous improvement are Six Sigma, Lean and Total Quality Management.

CI also goes by the name Kaizen. This method became famous in the book Kaizen: The Key to Japan’s Competitive Success by Masaaki Imai. Key features of Kaizen that I find advantageous in an SMS are:

  • Improvements are based on small, rather than radical, changes.
  • The ideas come from the talents of the existing front-line workforce.
  • Small improvements are less likely to require a major capital investment.
  • Employees are continually seeking ways to improve performance.

This method also encourages staff to take ownership and can help reinforce teamwork, thereby improving employee motivation.
All said, it doesn’t matter which method of CI you prefer, only that your SMS is continually improved!

Yes, you’ll find all this at your local blood bank; in fact, you’ll find a great treasure trove of resources on safety assurance from clinical lab associations and accrediting bodies.

With gratitude to St. Mary’s Hospital & Regional Medical Center’s Blood Donor Center in Grand Junction, Colo.

Michael Greene, R.N., MBA, MSHA, is a senior associate at Fitch & Associates. He has served in numerous front-line and leadership positions throughout his career, working in volunteer and paid search and rescue and as a paramedic, county EMS director and air medical/critical care transport director. He is the author of numerous articles and chapters on EMS and air medical transport topics. He can be reached via e-mail at mgreene@fitchassoc.com or by phone at 816-431-2600.

Produced in partnership with NEMSMA, Paramedic Chief: Best Practices for the Progressive EMS Leader provides the latest research and most relevant leadership advice to EMS managers and executives. From emerging trends to analysis and insight, practical case studies to leadership development advice, Paramedic Chief is packed with useful, valuable ideas you simply can’t get anywhere else.