Safety management systems (SMS) have been at the forefront of safety-related initiatives in the aviation industry for the last several years. There are numerous associations hosting and providing presentations on safety at industry conferences. There are private and government entities that contribute to safety, both occupational and operational. Safety management programmes at individual operators include daily briefings on safety topics and some organizations even hold events to promote safety. But what are the distinctive features of SMS in the air medical industry?

SMS related initiatives

Safety is indeed a key ingredient in all aviation operations and industry bodies are committing efforts through SMS-related initiatives in the air medical sector. One such body is the National Accreditation Alliance of Medical Transport Applications (NAAMTA). “Our view on successful SMS begins with regulatory criteria in written policies, includes clear processes that look at safety from various perspectives and sets goals to measure if the desired outcomes are being met. This sentence may make it sound easy, but the key ingredient to success is understanding the needs and personality of the organization. Initiating an SMS has to fit the organization and may begin with a few steps to develop its program and a plan to grow the system as foundations solidify,” said Roylen Griffin, Executive Director of NAAMTA. “As an ISO 9001:2015 quality management system company, we incorporate the ‘plan, do, check, act’ quality management techniques into our accreditation standards. This requires compliance with quality, safety, risk, and fatigue management criteria for our accredited operators.”

Bill Cline, Chief Pilot of US-based Air Ambulance Worldwide, explained that currently, only FAR Part 121 air carriers are required to utilize SMS in their everyday operations. He added: “FAR Part 135 air carriers are invited to participate, but it is a voluntary program. Air Ambulance Worldwide and its air carrier, Air Gato Enterprises, have begun implementation of our SMS program through the FAA.”

Industry associations in the US are encouraging their membership to actively participate in the Federal Aviation Administration’s (FAA’s) voluntary SMS program. “This is done through the sharing of best practices and experiences by members, as well as engaging directly with the FAA’s SMS program office, AFS-910, and having them present at association meetings. This integration provides great opportunities for guidance from the FAA office responsible for the program, as well as feedback from the operators on challenges and opportunities,” said Joseph Resnik, Vice-President of Safety at Air Methods.

SMS requirements

The Commission on Accreditation of Medical Transport Systems (CAMTS) also sets out SMS implementation requirements in its standards. “The mission is to improve patient care and safety of the transport environment. Requiring that a medical transport service has an SMS is just part of the overall safety expectations,” said Eileen Frazer, Executive Director of CAMTS. “Specifically, since 2010 the standards require that SMS must include a statement of policy commitment from the accountable executive, a risk identification process and risk management plan that include a non-punitive system for employees to report hazards, risks and safety concerns, a system to track, trend and mitigate errors or hazards, a system to track and document incident root cause analysis, a safety manual (electronic or hard copy), a system to audit and review organizational policy and procedures, ongoing safety training for all personnel (including managers) and a system of proactive and reactive procedures to ensure compliance.”

In the US, the FAA has specific guidelines and implementation procedures that have to be followed. “SMS has been a part of FAR Part 121 air carriers for a while now and [the FAA] have seen the improvement and success of the program. While it has not been mandated by the FAA for FAR Part 135 air carriers, the design and planned events / benchmarks are similar. The FAA inspectors that are a part of the process for 135 air carriers welcome the participation and have been working closely with us to implement our system. It is a very long and detailed process, one that requires co-ordination and participation by both parties,” Cline told AirMed&Rescue.

One of the main SMS requirements is that having a full implementation plan is essential.

The expectation would be for an initial reactive SMS with details of how it will move forward to a generative SMS

The expectation would be for an initial reactive SMS with details of how it will move forward to a generative SMS. For the Royal Flying Doctor Service in Australia, it’s all about the detailed processes. “Systems and procedures expected to be in place include a functioning reporting system, software and appropriate personnel, and bodies such as safety action groups and a safety review board. While it is accepted that full safety culture transition takes years to become fully embedded, processes need to be in place. Safety assurance activities will require time to mature but must move forward even if commencing in a somewhat embryonic state. Most important is a safety policy clearly defining management commitment,” explained Rob Alexandra, Aviation Safety Manager for the Royal Flying Doctor Service’s Queensland Section. “Our State Government’s health service has expectations that organizations are accredited with ISO compliance, health accreditations and aviation SMS."

A unique operational challenge

In the past, as NAAMTA audited documented safety programs and interviewed personnel, it was learnt that the policies existed, but the documentation of safety-related items were less consistent across the board. “When one considers the high risk associated with medical transports, most organizations are safe in their actions, but the documentation to demonstrate their safety practices or to follow through on items gets pushed aside as other priorities arise. Monitoring events, identifying resolutions, and ensuring they can be closed prevents reoccurrence. We can learn from others, as long as we understand the processes involved. Understanding the what, why and how of problems helps us close the problem out and share what was learned,” said Griffin.

Another important aspect is that the unique circumstances of aeromedical transports require pieces from various resources, but putting the safety puzzle together continues to lack the complete picture, observes Griffin. “Using the puzzle concept, pieces must be utilized from the aviation industry, additional pieces come from the medical industry, more from maintenance and each entity has good input,” he said. “Now that the FAA is moving forward with the requirement of an SMS, NAAMTA is ramping up its safety standards. These new standards will incorporate input from the ISO 45001 Health and Safety Standard. As our accredited members submit their quarterly reporting for quality, safety, risk and fatigue management, trends can be identified and shared with our alliance members. Through this process, we have seen much progress in the world of safety of our organizations.”

CAMTS standards also specifically address safety culture. “A Safety Culture Survey is sent to each employee prior to a site visit and is an important part of the board of director’s final review. It was originally based on the AHRQ Patient Safety Culture and it has been redesigned based on the Safety Attitudes Questionnaire (SAQ) by the University of Texas Center for Excellence. The final analysis of the data results in a report sent to the program that compares their scores to other programs,” said Eileen Frazer. “Questions are carefully designed to measure thoughts and attitudes about teamwork, safety climate, job satisfaction, stress recognition, perception of management and working conditions. The individual taking the survey is also able to submit comments that may help the site surveyors frame their questions during interviews.”

A major challenge for aeromedical services is that an aviation operator may have an SMS that fulfils the requirements of the FAA or European Aviation Safety Agency (EASA), but does not incorporate the medical crew factors of teamwork and patient care issues. “If the aviation operator does not employ the medical crews, we often find two different SMS. In this case, we will encourage that the staff understands each SMS and their responsibilities of reporting safety concerns through the appropriate chain of command for an open and transparent process,” said Frazer.

Organisational experiences

Through SMS implementation, there is an opportunity for significant improvement in change management. “With SMS, there is a more formalized and structured way of identifying risks on the front end of projects and putting mitigations in place prior to implementation. It provides a more proactive culture as opposed to a reactive culture. It is a culture change for an organization,” said Resnik. The safety culture must be driven from top management to each base and each employee.

The safety culture must be driven from top management to each base and each employee.

“Implementing a process to document, record action items, and create a loop-closure to verify that safety issues are not just closed, but that the resolution is verified and validated is key. The time frame to incorporate all SMS requirements is dependent upon the personality of the organization. Another factor is the amount of resources the company applies to the safety system, as it makes the difference in timing. This is not an overnight solution, but if everyone in the company shares in the process, the safety culture comes together,” said Griffin.

SMS implementation also comes with some hurdles to overcome, as Resnik pointed out: “A main part of risk mitigation is engaging all parts of the organization that may be affected by a change or identified hazard / risk. Creating that engagement and collaboration as a normal rhythm within the company’s culture can be a challenge.”

“For Air Methods, [SMS implementation] has been a matter of integrating the safety organization as a facilitator of the risk assessments, actively engaging the other departments to know they have our support from the top down. Additionally, engaging the senior leaders to ensure they are driving their teams in the right direction and setting the expectation has been a tremendous help. Because we already had the basic structure in place, we have been able to move quickly and expect to have full conformance in 2020. Typically, the initial gap analysis and development of the implementation plan can take up to a year with full implementation and conformance completed within 36 months after the FAA’s acceptance of the plan,” said Resnik.

When there is commonality in the desired outcome and employees are engaged in the process, the entire organization maintains an awareness of the overall safety goals. “Truly, there is no end to building a SMS, just progress,” said Griffin. “An organization has to consider how it will measure progress and assess whether each department is setting indicators for safety compliance and whether these mesh with company goals. These indicators or goals should be measurable. With these measures, one can assess the activities, determine if the desired outcome is achieved, and then determine if a focus needs to be placed on another factor of safety for the next quarter. The SMS takes on a life that evolves, circles back, and moves forward as the needs of the organisation are monitored.”

Air medical operations

There are specific aspects that air operators have to consider when conducting air medical operations as opposed to regular commercial operations. The Royal Flying Doctor Service of Australia was established in 1928 as a charitable organization to provide health services to remote and isolated communities. The focus has always been on the provision of healthcare. “Engagement with the clinical side of the organization on aviation safety matters has naturally presented some cultural challenges. For example, medical and aviation risks are measured differently, medical focusses more on what was the level of harm done, if any, while aviation assesses what was the potential for harm,” said Alexandra. “We have the same goals, but speak different languages, which naturally presents its own challenges. Fortunately, we have clear lines of communication within the organization to help overcome these obstacles.”

By assessing all the contributing factors of a medical transport, it is possible to see the variety and the need for documented processes and a solid SMS. “The most important thing is to start with the needs of the patient and assess if a solution can be provided. Then it is necessary to consider who is making the transport request and if there is an insurance or an assistance company involved in the process with specific criteria that need to be factored,” said Griffin. “Questions that typically need to be asked include: Is the information provided accurate? Is the timeframe realistic? Will the transport require a crew change? Is the receiving facility verified with a bed for the patient? One then needs to add the elements of aviation, the lifesaving efforts of the medical crew, the unique and varying needs of the patient, the potential dynamics of accompanying family members.”

The realisation of every variable can be a demanding task. “The challenge is to start with building the foundation and then adding elements to reach the desired outcome. No transport is ever alike; therefore, we learn as we experience, we document and share the lessons learned,” said Griffin.

Indeed, each air ambulance mission is a unique undertaking. “Whereas commercial scheduled operators know their routings a year in advance, we typically receive our callouts two hours before wheels up. This presents a risk that commercial carriers do not typically face and therefore air ambulance operators see a huge benefit from creating and implementing an SMS programme,” said Cline. “Our type of operation demands different types of people, backgrounds, professions, to be brought together. Being a cultural and regimented programme, all our groups work together to make the full SMS implementation a successful experience.”