I’ve been in the business of safety management a long time and frankly I’m amazed and a bit confused at healthcare’s apparent insistence on the use of quality initiatives to solve patient safety problems. Could it be that the healthcare industry believes quality = safety? Most in healthcare speak profoundly of patient safety yet attempts to explain patient safety efforts seem to focus only on quality. Why?

As an example, Wikipedia provides the following reference for Kaizen as follows:

“Japanese for “improvement”, or “change for the better” refers to philosophy or practices that focus upon continuous improvement of processes in manufacturing, engineering, game development, and business management. It has been applied in healthcare,[1] psychotherapy,[2] life-coaching, government, banking, and other industries. When used in the business sense and applied to the workplace, Kaizen refers to activities that continually improve all functions, and involves all employees from the CEO to the assembly line workers. It also applies to processes, such as purchasing and logistics, that cross-organizational boundaries into the supply chain.[3] By improving standardized activities and processes, Kaizen aims to eliminate waste (see lean manufacturing). Kaizen was first implemented in several Japanese businesses after the Second World War, influenced in part by American business and quality management teachers who visited the country. It has since spread throughout the world[4] and is now being implemented in many other venues besides just business and productivity.”

Notice there is not one mention, even reference to the word “safety.” One could argue that safety is implied but it certainly is not mentioned. You would think that with all the negative press stemming from the 1999 IOM report, clear, rigorous focus would be on improving (patient) safety not just quality.

Having been involved in safety management in both commercial aviation and healthcare, it’s quite interesting to witness the differences regarding how each goes about reducing risk, improving safety, achieving high quality and efficiency, and improving safety culture. I can assure you the two industries approaches couldn’t be further apart.

Healthcare is captivated with quality improvement programs that have a long-standing history in Japanese manufacturing (Six Sigma, LEAN Six Sigma, etc.) as cited in the Wikipedia reference above. Commercial aviation and other high-risk, high-reliability industries (oil & gas, nuclear power, and others) incorporate “System Safety” which includes quality (both quality control and quality assurance) to design safety and quality into all systems and associated processes. Does LEAN, Six Sigma, or Kaizen do this?

It’s important to note with both Lean and Six Sigma or Lean Six Sigma focus is on the customer and improving the “value chain.” Lean is supposed to set standard solutions to common problems and its focus on the customer. Lean seeks to prevent sub-optimization by its focus on the entire value chain. Lean provides a total system approach but falls short on details, organizational structures, and analytic tools for diagnosis. In other words, Lean has a tendency to oversimplify.

Six Sigma on the other hand offers fewer standard solutions but provides a general analytic framework for statistical based problem solving and an organizational infrastructure. The downside with Six Sigma is the opposite of Lean in that it can be too complex for the targeted problem.

As such, Lean and Six Sigma by themselves were not sufficient to carry the weight of their intended quality improvement purposes in the service sector. As such they were combined to allow the strengths of each to make up for each other’s weaknesses. In theory the result should be a sound, quantitative, measurable, continuous “quality” improvement of processes and elimination or reduction of waste (inventory, supplies, overlap, etc.).

So, here’s my problem with Lean Six Sigma… Quality is often, if not always, misconstrued as a substitute for safety. Quality does not equal safety. Think of quality and safety as cousins on the family tree. Both are related but NOT, I repeat, NOT the same thing!

We use the term “quality” in many different contexts; all quality products or services have certain common characteristics. The first common characteristic is something called “conformance to requirements.” In other words, the product or service offered meets all predetermined specifications established by manufacturers, vendors, customers, and us (i.e. an aircraft engine, defibrillator, etc.). The second common characteristic is “fitness for use,” which means that our product or service meets or exceeds our customers’ expectations (i.e. aircraft engine or defibrillator works as advertised or better).

Safety, on the other hand, is the minimization and management of risk.

It’s probably worth talking about customer expectations for a minute here. Most customers (patients) do not specify their expectations of our offered products and services. They just want to feel better and go home. There is however, an unstated customer expectation that desired products and services will be of the highest quality, all, or at least most of the time. Unfortunately, lack of specific customer (patient) input represents a potential challenge as quality decisions are left up to the individual hospital and practitioner. Granted, some quality decisions are intuitive such as customer service. Others however, may not be so obvious. One possible solution for hospital leadership is to place themselves in the shoes of their customers (patients) and ask, if they were the customer, what would their expectation be for products and services?

There are many examples of people incorrectly assuming quality equals safety. For example, processes designed to produce a quality product, (repeatedly doing the same thing, without variation), equate to the same thing as repeatedly producing a safe product.

Remember the fairly recent Toyota Prius incident with stuck accelerators? The Toyota Prius accelerator parts were manufactured to a particular specification (an incorrect one), and the quality system in place was designed to detect any variance of the process, and adjust the process to bring the production back in line with the specification. In effect, Toyota had a quality product. The accelerators were produced as specified, repeatedly without variation outside of established limits. It’s plainly obvious now that Toyota did not have a safe product primarily because they did not connect the dots between failures of the product during use to failures of the production process.

Herein lies my beef with strictly using quality management protocols (Lean Six Sigma and others) to solve patient safety problems. Quality management protocols simply do not consider risk, human factors, culture, or established inherent safety characteristics of a system or process (responsibility, authority, procedures, controls, risk-point process measurements, and interfaces between processes).

Maybe it’s time the healthcare industry implement system safety to solve patient safety problems. Maybe then a safe system can be achieved including the ability to connect the dots between failures or potential failures of a product or service during use to failures or potential failures in the quality process, something quality programs on their own are simply not designed to do.

Personally, I’ve always referred to culture as “the way we do things around here especially when no one is watching.” To explain, “the way we do things around here” is the system or environment. In other words, “the way we do things around here” in my hospital, my unit, my ED, my lab, my pharmacy, and so on. “Especially when no one is watching” means when management personnel aren’t around (nights, weekends, etc.). And let me assure you, no two hospitals operate the same way in exactly the same manner just like no two airlines, who happen to fly the same type of aircraft, operate the same way. How can that be you ask? Because of culture.

Unfortunately, no one seems to recognize, or at least write much about the fact that “the way we do things around here” is predicated on the systems and processes provided by the environment in which we work. You know, the hospital, airline, where ever… Where do the systems and processes that exist in our places of work come from? You guessed it, management. Management is solely responsible and accountable for the systems and processes that are provided in our places of work. It’s specifically from those very systems and processes that culture is manifested.

Looked at another way, poorly designed, fragmented, broken systems and processes that lead to “work-arounds” are a classic enabler through which culture is developed. Front line personnel quickly figure out how the “system” works and what “work-arounds” are acceptable. They also clearly recognize, even witness management’s tolerance of these deviances, and come to expect that “this is the way we do things around here!”

I’ve often said that healthcare is decades behind other high-risk, high-reliability industries like commercial aviation, petroleum, nuclear power, and others. I believe this is so because of education and training on human factors, safety, risk, and quality management, accident (adverse event) analysis and investigation, and, of course, culture.

The solution lies in the system. Fix the clinical care systems and processes and culture will follow. By “fixing” I mean, design system safety into all clinical care systems and processes so that specific, definable, data-driven, safety and quality attributes become identifiable, measurable elements of the system. Designing safety into systems and processes rather than trying to inspect safety into them makes each system more risk averse, of higher quality, and part of an integrated whole which is far easier to manage, hence the beginnings of a Safety Management System (SMS). Don’t believe me? Call up any airline and ask for a tour of their safety department. Ask to see their SMS, their system and process documents, their internal evaluation programs? Then ask to see how safety is integrated into training programs, line operations, and technical publications. Ask to see how “lessons learned” are de-identified and communicated back to the entire operation without the threat of punishment. And finally ask front line personnel what their roles and expectations in safety are and have them show you the tools that are available for them to use in communicating, reporting, and protecting themselves from a standpoint of safety.

After taking the tour, ask yourselves how safely designed systems combined with a management system to oversee them impact culture. If this exercise isn’t convincing that the system drives the culture I’m not sure what will.

When aircraft are designed, flight critical systems and components, including IT, must be failsafe to 10⁹. That’s one in one billion chance of failure!! If flight critical systems and components cannot achieve 10⁹ independently then redundancy must be designed into those systems and components to compensate. Failsafe design is an integral part of a risk management protocol known as system safety and from my experience, system safety is a completely foreign concept in healthcare, certainly healthcare IT.

To this point, Mr. Collins’ blog states that, “routinely hospital boards order the installation of information systems without proven backup arrangements and certification. Absent in health IT are the mandatory standards that underpin air safety.” And, “those who fly sometimes owe their lives to the proven and certified backup arrangements on civil aircraft. Compare this safety culture to the improvised and sometimes improvident way some health IT systems are tested and deployed.” I for one cannot agree more!

Frankly, I was a bit surprised to read about some of the deficiencies cited in an independent study of the Summary Care Records and its database. Some of the deficiencies cited include:

• Omitted some medications
• Listed “current” medication the patient was not taking
• Included indicated allergies or adverse reactions which the patient probably did not have

The independent study also claimed, “electronic health records can also record wrong dosages of drugs, or the wrong drugs, or fail to provide an alert when clinical staff have come to wrongly rely on such an alert.” Not exactly the kind of things a patient wants to hear.

In my experience, patient safety in healthcare is a good 30 years behind commercial aviation and other high-risk, high-reliability industries. My fear, therefore, is that on a large scale patient safety won’t improve all that much unless some significant external catalyst drives change. Maybe airline-style certification and regulation is that catalyst…

The hospital, touted as the first to be built in the state in more than 20 years, was proudly introduced as being able to deliver first-class, state-of-the-art quality patient care. Politicians and senior hospital officials eagerly declared that residents of the county and surrounding areas will no longer have to go to the big city. They can stay right here close to home, close to family, close to friends, and care for their health in the comfort of their own community. And of course with the new facility came frequent energized reference for the strong desire to deliver high-quality, safe patient care.

Now, a little more than three months later, the shining new hospital stands proudly in a clearing once filled with overgrown woods adjacent to an intersection of east-west, north-south interstates. Grass has begun to slowly cover areas of exposed dirt left over from construction and the building is architecturally pleasing to look at making it a positive addition to the community. The hospital really does look great!

But I was curious, transitioning to a new hospital, especially one of this size is no simple task. I was wondering how things were going?

About a week ago my wife and I went out to dinner with friends. The dinner has become a post Thanksgiving reunion of sorts. With our busy lives and some of us separated by distance, most of us don’t get to see one another throughout the year as much as we’d like, if at all. So our annual reunion has become a highly anticipated evening of pleasant conversation and good food. Professional backgrounds of our friends vary widely from pilot and consultant (me), firefighter, nurse, Wall Street financier, electricians, money manager, physical therapist, office manager, and former professional ballet dancer now very busy stay-at-home mom to three kids (my wife).

As you can imagine conversations covered just about everything – kids, holidays, work, politics – you name it. What I did find interesting was one particular conversation we had about work with our friend who happens to be a nurse at the newly christened hospital. Our friend was quite adamant about the complete lack of training on new equipment, inadequate staffing, and how supplies were hard to come by and very difficult to locate at the new facility.

In and of itself I didn’t find our friends claims terribly unusual. Frankly, I’d be surprised not to hear about equipment, communication, supplies, and work-flow issues at a new facility. However, the problem I was having is this was not the first time I’d heard these very same claims about this very same hospital. In fact, I can directly attest to our friend’s claims as I happened to be a patient at the new hospital for a minor procedure just a few weeks ago. I witnessed, first hand, nurses openly complaining about not knowing how to use certain equipment properly because they were not trained. Nurses also complained about the lack of both equipment and supplies and many still had difficulty finding their way around the new facility. Believe me when I say there were yellow post-it notes loosely hanging in many locations serving as gentle reminders about a variety of subjects including directions to other hospital locations.

One would think the issues regarding training, equipment, staffing, and supplies are bad enough but what really concerned me was the entrenched attitude of “business as usual.” Nurses and other staff were clearly frustrated but otherwise rather unfazed at their working conditions. I have long argued that the “business as usual” attitude exhibited by “unfazed” nurses, physicians, and staff combined with senior management’s incessant public claims of patient safety and quality being high-priorities is where the real hospital culture resides. Front line personnel have little choice but to press-on with their work doing whatever it takes to get the job done, thus establishing and continually reinforcing the “work-around.” Worse yet, senior management is aware of the deviances in clinical work practices yet tolerates the deviances until something bad happens, of course.

All right, enough about culture, what about risk? Has anyone at the new hospital done a risk assessment (prior to as well as after the move) not only in the few areas discussed above but in all areas that should be contained in a systems-based Safety Management System or similar type of Patient Safety Program? Because from my chair the risk in light of the deficiencies we’ve been talking about is off the charts HIGH!

Another friend at our annual dinner, the Wall Street financier, told me a story about Robert Crandall, former CEO of American Airlines. As the story goes, American Airlines was revitalizing one of their South American stations and Mr. Crandall wanted to cut costs. Sounded reasonable enough. Anyway, the story centered on the station manager and his security budget (pre-9/11). The station’s budget called for two full-time security guards as it was a relatively small station. Mr. Crandall asked the station manager how much crime took place or other security issues that posed enough risk to require two full-time security guards. The station manager replied that crime was very low and there were no apparent security issues to speak of. Mr. Crandall instructed the station manager to fire one of the security guards and let him know if crime or security problems increased.

A few months went by and Mr. Crandall called the station manager to inquire about how things were going with one less security guard. The station manager replied “no change.” Mr. Crandall then instructed the station manager to fire the remaining security guard and get a guard dog to replace him and call him right away if anything changes. The station manager complied.

Another few months go by and Mr. Crandall again calls the station manager to see how things are going. The station manager again reports “no change.” As such, Mr. Crandall then instructs the station manager to fire the guard dog and install security cameras with the same request to immediately call if anything changes.

The moral of the story are the systematic actions Mr. Crandall took to cut costs without increasing subsequent risk as a result of the changes made to the stations security. After each cost cutting change, orders from the former CEO were clear, “call me if anything changes.” Mr. Crandall was undoubtedly ready to immediately respond to negative changes in security as he actively searched for a tolerable cost (risk) point in the system.

While Mr. Crandall may not have been a safety, quality, or risk management expert he was keenly aware how the system worked and how risk exists and needs to be respected as well as managed in daily business decisions, at least in this case. All of this makes me wonder, is it possible the senior management team at the new hospital calculated and deployed risk countermeasures to the hospital’s grand opening in a way similar to Mr. Crandall’s example? Or was it simply business as usual with the additional risk exposure of moving into a new, unfamiliar hospital hoping things work out?

I particularly agree with and fully support one of Dr. Appel’s final comments, “There are no short cuts. No lecture is going to do anything for patient safety.”

Hopefully hospital and health system administrators will take notice and take real, systems-based patient safety improvements!

Enjoy the article!

Upon reading the article I was pleased to learn that North Shore’s approach to its video technology tracking application is one that appears to be completely de-identified and non-jeopardy! The video technology tracks and presents aggregate data only and that is very important for lasting success, not too mention cultural acceptance!

The video tracking technology also presents data to front-line personnel in real-time and adds the unique twist of providing fun messages such as “Great Shift!!!” based on the hand-hygiene rate. This strategy provides immediate feedback to front-line personnel and serves as a friendly, professional challenge of sorts, in a health kind of way (no pun intended). Similar tracking technologies are being used in commercial aviation and have done a wonderful job at providing useful information and most importantly improving safety!

The latter part of the article discusses some of the difficulties associated with hand-hygiene tracking and raises an interesting, or maybe better said, troubling point…medicine only pays attention when there are studies in a peer-reviewed journal. The good news is North Shore Study is now published in the journal of Clinical Infectious Diseases. The bad news is why does it take a peer-reviewed clinical study in order for safety, risk, quality, and cultural improvement solutions to be recognized, let alone implemented? If commercial aviation and other high-risk, high-reliability industries adopted this strategy we’d be in big trouble!

Don’t get me wrong, peer-reviewed clinical trials provide excellent value and ideally serve to allow adequate review and implementation of clinical care practices and equipment in an effort to improve patient care. However, especially given the current state of safety and quality in healthcare today there is neither the time, resources, or other valid reason to apply the same strategy to safety, risk, quality, and cultural improvements. Just imagine if commercial aviation took this approach…

Imagine that, physicians, who some argue perform more technically complex, critical tasks than pilots do flying airplanes, go through entire careers without ever being evaluated on their skills and competency. Doesn’t seem to pass the common sense test, does it?!

High-risk, high-reliability industries have long recognized that rigorous and continuous training, evaluation, and feedback are essential, integral components of a safe, efficient, high quality system. Not only is training important but currency as well. Case in point, I recently had foot surgery and in casual conversation with my surgeon he agreed that surgeons need to perform surgery regularly to remain proficient, just like pilots making takeoffs and landings. I should point out that airline pilots have minimum currency requirements for a variety of flight critical tasks. Perhaps this is something the healthcare community should embrace!

No small task to be sure. You need to map out a plan for essentially determining whether or not Metropolitan Hospital System has a Safety Management System (SMS). Since SMS is a brand new concept in healthcare you have to be innovative in creating your plan because there simply is no guidance, standard, or healthcare industry reference material for you to rely on for the project.

So, after careful consideration you decide to find out how other high-risk, high-reliability industries manage safety in their daily operations. You quickly discover that many high-risk, high-reliability industries utilize a Safety Management System or SMS. In fact, SMS is very mature in the chemical, oil & gas, nuclear power, and aviation industries.

Your research into other high-risk, high-reliability industries leads you to decide to investigate Metropolitan Hospital System for the proposed SMS compliance by following a simple plan made up of common SMS tenants. They are:

• Safety Policy
• Clinical Process Descriptions
• Clinical Process Measurements
• Record Keeping
• Risk Assessment
• Change Management
• Observing Metropolitan Hospital System’s Safety Programs, and
• Key questions for Metropolitan Hospital System front-line (non-management) employees

First up, safety policy. Safety policy sets the organizational tone of an organization and is the cornerstone of SMS. Policies are the “shall’s and shall-not’s” applying to all personnel and essentially is the strategic vision and commitment to the established values of the organization. Policies also provide guidance for the development of new clinical processes and internal standards against which those very clinical processes can be evaluated. Examples include:

• All clinical process descriptions will (shall) identify one or more Key Process Indicators (KPI) so the performance of the clinical process can be evaluated.
• Or, all clinical processes shall clearly define the responsibilities and authorities of those in charge of a process including when and how authorities can be delegated.

Policy documentation is a critical component in a SMS. Similar to a Quality Management System that must have a quality policy manual a SMS must have the equivalent of a Safety Policy Manual.

Reviewing safety policy documentation is a great first step in verifying a SMS exists.

Next is a review of a sample of clinical process descriptions. Clinical process descriptions for say, medication reconciliation should include clear, standardized instructions for a healthcare professional to do their job. An example of a more complex process description is patient discharge that might, in addition to having clear, standardized instructions, contain a multi-departmental process workflow diagram. High-quality clinical process descriptions will always follow a standardized format and will always tell you who’s in charge of the process (responsibility), how success of the process is measured, and what records are maintained.

Logically then, the next step is to evaluate clinical process measurements. Quality organizations must establish measures within its processes to facilitate continuous monitoring of performance. A SMS must do the same to determine whether clinical processes are meeting assigned safety targets. A SMS targets for measurement specific points within the process that contain the most risk. Also, Metropolitan Hospital System should be able to tell you why a particular process measurement has been established – very important!

Moving on, you come to record-keeping. Aside from items requiring records that are regulatory in nature or are required to comply with third party constraints, records should primarily be kept to facilitate management review. SMS records should carefully record and reference the decision-making processes involved in management review. Records relating to adverse events (reactive) should be categorized to specifically show:

• What happened?
• Why did it happen?
• What was the effect?
• How is the Metropolitan Hospital System going to decrease the risk of an adverse event recurring?
• Who is responsible and accountable for corrective action?
• And, most importantly, did the corrective action work?

Records relating to proactive safety efforts records should specifically show:

• What might happen?
• Why it might happen?
• Are proactive interventions working?

Management review requires the availability of good records so the organization must be able to produce safety records when needed.

Now, you want to know how Metropolitan Hospital System assesses risk? This is a very important question and careful attention should be paid to the answer. Answers to this question should describe a formal, practical way to assess, classify, and prioritize risk. Answers should not be a guess!

Recognizing a SMS by asking how you manage change?

Another important question to ask is “how do you manage change?” Everything that’s been discussed so far is moot unless an effective safety change management process is established. Of course, it’s important to validate documented change management process descriptions, process measurements, change management records. However, it’s equally important to hear Metropolitan Hospital System’s change management process described as well as be able to point to success stories resulting from the change management process.

Recognizing a SMS by observing safety programs

If safety policies are the cornerstone of a SMS then specific (patient) safety programs represent its backbone. Those in charge of safety management at Metropolitan Hospital System should be able to fluently describe their safety programs. Listening to safety program descriptions are key. You’re looking for proactive descriptions. Safety programs should be described in a way that actively seeks sources of new information and new methods of risk control. Describing safety programs in a reactive manner is not good. Waiting for adverse events to happen can be disastrous, not to mention expensive!

Recognizing a SMS by taking it to the employees

Safety is supposed to be driven to all parts, levels, departments, and corners of an organization, right? So who better to ask about Metropolitan Hospital System’s SMS then its employees, not management but rather front line employees (i.e. nurses, physicians, lab technicians, pharmacists, hospitalists, etc.). Find a few and ask the following:

1. What are the greatest areas of risk in your area of work, and what do you do to mitigate that risk?
2. When was the last time that you or one of your colleagues were asked to help improve safety in your area of work?
3. What happens to you when you make a mistake?

If Metropolitan Hospital System has a well functioning SMS answers will reflect front-line knowledge and awareness of high-risk because areas of high-risk are well communicated. Not by communicating generic safety information but communicating specific, relevant safety information for each clinical care process. Also, reporting errors and mistakes should be encouraged and non-punitive!

What do you think?

While the scenario just presented is fictitious, how do you think Metropolitan Hospital System did considering the current state of patient safety in the healthcare industry? Better yet, how would your hospital or healthcare facility fair in this scenario?

And, of course, consistent with one of my pet peeves I was asked three times to verify I was actually the person my identification bracelet said I was. One nurse even went so far as to have me spell my name in full! Good thing we were both proficient in English…

As far as verification being a pet peeve of mine, I’ve said it before, it can be dangerous to repeatedly verify things. Over time, people can develop a kind of inattentional blindness or mental numbness as a result of verifying for the sake of verifying. It’s kind of like verifying for the tenth time that the landing gear on an airplane is down and locked. Eventually people (pilots) become numb to the verification process and inevitably people read the checklist without noticing (really verifying) that the landing gear is actually down and locked. Rare but it does occur.

Anyway, back to the pre-surgical testing. Questioning continued in a fairly standard fashion, you know, medical history (including family), prior surgeries and hospitalizations, allergies, current medications, etc. Interestingly, they did ask me some “dark” questions like have I ever thought of harming myself or someone else, do I feel threatened by anyone, and do I feel lonely or depressed at home? I suppose this line of questioning has something to do with a plantar fascia release?!

But what really took me by surprise was that there were no questions or mention whatsoever about the requirement for antibiotics due to being the recipient of bilateral knee replacements. When I brought this up, the interviewing nurse said she was sure the surgeon was aware and that she would “pass along” this information. Are you kidding?! Not only was there no mention, notation, marking, warning, color coding, or anything whatsoever on my identification bracelet but nothing in my chart either!

The promise to “pass the information along” and the statement that “I’m sure your surgeon is aware” was alarming! My surgeon is aware?! Hardly! You mean to tell me that my surgeon will remember me well enough out of all his patients and cases that he’ll remember the antibiotic requirement? So what you’re saying is that you are certain the surgeon will simply remember the antibiotic requirement just because they’re my doctor? Great, just great! Not only is an individual’s memory the last layer of defense against a potential medical mistake, it’s the only defense in this case. Well, that’s not much of a defense if you ask me!

After going back and forth with that little nugget for a short while I knew what I was in for when asking my remaining pre-operative questions. Have a look:

• Who’s in charge in the O.R? – This totally blew the interviewing nurse away. Although I do give her credit, she valiantly fought to find some semblance of an answer, of course to no avail. Finally, she admitted she frankly had never thought of O.R. management that way before and had no idea who was in charge.
• How is medication reconciliation accomplished? – This too turned out to be a stumper to which she admitted was essentially a list-to-list comparison. Heck I can do that!
• What is the infection rate at the facility? – This was answered similar to everyone else I’ve ever asked this question – terrific, we’ve never had a problem, I’ve never heard of someone having to come back because of infection. That’s right, because if a patient does get an infection they don’t go back to the outpatient surgical center, they go to the hospital!
• What is the reputation of my surgeon? – Answer – Oh, he’s fantastic. Everyone loves him. Similar to the prior question, I’ve also never met anyone directly involved in my process of care for any procedure I’ve had that ever had anything negative to say about any doctor or any part of the process for that matter. That’s right, everyone walks on water and everything is great!

This experience leaves me with the impression that the patient safety, standardization of care, quality, and safety culture has a tremendous way to go. What’s really scary is that I have a knowledge and background in patient safety, what about all those patients that do not?!

Astonishingly, Dr. Christopher P. Landrigan, lead author of the study and an assistant professor at the Harvard Medical School reports, “the findings were a disappointment but not a surprise” and this is extremely important, “that many of the problems were caused by the hospital’s failures to use part measures that had been proved to avert mistakes and to prevent infections from devices like urinary catheters, ventilators, and lines inserted into veins and arteries.” And, “until there is a more coordinated effort to implement those strategies proven beneficial, I think that progress in patient safety will be very slow.”

The Problem – Well, that’s pretty clearly defined. Just read the New York Times article.

The Solution – System Safety and a comprehensive, data-driven Safety Management System (SMS).

System Safety is the application of special technical and managerial skills in a systematic, forward-looking manner to identify, analyze, assess, and control hazards and risks within your healthcare organization. Every system and process should have tangible safety characteristics. They are:

1. Responsibility (who’s in charge),
2. Authority (who can make changes to the system or process),
3. Procedures,
4. Controls,
5. Process measurements, and
6. Interfaces (content consistency of policies and procedures between departments and disciplines).

A Safety Management System (SMS) is simply the management system used by your organization to manage safety, quality, and risk within every system, sub-system, and process (i.e. medication administration, labor and delivery, ICU, O.R., Emergency Department, radiology, etc.). By applying a comprehensive, data-driven SMS to clinical systems in your organization, you’re in a much better position to identify active and latent hazards and risks and do something about them before system failures result in adverse events!

Specific tools and risk reduction strategies resulting from System Safety and SMS include:

• Checklists
• TeamSTEPPS
• Just Culture
• Error Reporting
• Regulatory Compliance management
• Joint Commission (or anyone else for that matter) Inspection Readiness
• Robust Corrective Action Planning
• Standard Phraseology
• SBAR
• Document Management including Revision and Control
• Evidence-Based Standard Operating Procedures
• Quality Control and Quality Assurance
• Realistic Patient Safety Training (simulation if possible)
• Real-time Risk Awareness in every clinical system, sub-system, and process

These are just some of the sustainable, realized benefits of System Safety and a SMS. And the best part is you don’t need to reinvent the wheel. Other high-risk, high-reliability industries and organizations have a long standing wealth of knowledge and experience in both the development and implementation of System Safety and SMS. The analogy here isn’t between doctors and pilots, it’s between one high-risk, high-reliability industry to another.

According to the North Carolina study, the costs associated with just the extra treatment required as a result of injuries could cost Medicare several billion dollars per year. I can assure you, implementation of System Safety and a SMS doesn’t cost anywhere near that amount!