Furthermore, a culture of blame discourages health care workers from reporting near-miss situations, while the identification of a person to blame deflects attention from the underlying problems that caused the incident to happen.
Considerable trouble, ill will, and malpractice litigation can be avoided when hospital administrators recognize that the system is responsible for most medical errors, encourage health care workers to identify deficiencies in the system, and implement closed loop corrective action (CLCA) to remedy them.
In addition, many medical errors would probably be close to impossible in an ISO 9001:2000 compliant hospital. ISO 9001:2000 is an internationally recognized standard for quality management systems, and International Workshop Agreement IWA‑1 from the American Society for Quality and Automotive Industry Action Group is a health care specific modification.
Where Do Problems Come From?
It is a general rule in industry that only 15 to 20 percent of trouble comes from negligence, carelessness, and incompetence. The rest is due to deficient organizational systems that make trouble almost unavoidable. W. Edwards Deming's 85/15 rule says that 85 percent of all defects and errors are the fault of the system in which people must work, while 15 percent results from carelessness and negligence. Frank Gryna cites an 80:20 ratio, with 80 percent of errors and mistakes being "management-controllable" and only 20 being "worker-controllable." [1]
The typical cause and effect diagram (also known as the fishbone diagram because of its shape, or the Ishikawa diagram after one of its principal exponents) displays six main categories of problem sources. It uses the mnemonic acronym 6M or "5Ms and E" to make them easy to remember.
Machine (Equipment)
Faulty or unsuitable equipment is a common source of trouble. In a hospital, equipment that is hard to sterilize or disinfect can transmit disease bacteria. Any equipment that relies on the health care worker's vigilance to prevent it from harming the patient should be considered unsuitable for the job. Jidoka (autonomation) means that the equipment can recognize abnormal conditions, and either correct those conditions or shut down and sound an alarm.
One discussion thread in Allnurses.com [2] describes how a failure in an intravenous device's roller clamp delivered an hour's worth of potassium chloride in less than ten minutes, thus causing the patient's death. In contrast to gravity-fed equipment that can conceivably deliver unlimited or uncontrolled flow in the event of a valve or clamp failure, a pump cannot provide more flow than its electronic control system allows. A very quick Google search shows that the technology is available.
The invention is concerned with controlling fluid delivery by a fluid dispensing system in which fluid is dispensed from a container, through a delivery tube, under the control of a flow controller or peristaltic pump and, particularly, with the control of the rate of fluid delivery to a patient by an intravenous infusion system utilizing a standard administration set. [3]
Again, if the equipment must rely on the nurse's vigilance to make sure it does not harm or kill the patient, it is probably not suitable for the job.
Method (the procedure for the job)
If a nurse gives a patient the wrong medication or the wrong dose because she didn't understand the doctor's verbal instruction, who is at fault? The answer is probably the lack of a verbal order read back procedure, in which the nurse repeats back to the doctor what she thought she heard. If the hospital administrators blame a person instead of the procedure, it is only a matter of time until the same thing happens again.
Manpower (personnel; the gender-specific term allows the 6M acronym).
Assignment of inadequately trained personnel to a job would fall into this category. The ISO 9001:2000 quality system standard requires the organization to demonstrate how it ensures that people are qualified for the jobs to which it assigns them.
Inadequate staffing--for which management is ultimately responsible--is another personnel issue. "We didn't have enough people to perform all the quality checks" is never accepted as an excuse when a supplier delivers faulty products to a customer, and inadequate staffing should be even less excusable in a hospital or nursing home.
Measurements
In a hospital, these include testing and diagnostic equipment.
Materials (consumable items)
In health care, these include medications, antiseptics, dressings, and so on. The typical difference between a machine and a material is that the former is durable while the latter is consumable. However, a single-use piece of equipment like a disposable syringe would probably be classified as equipment rather than material.
Environment or Medium (the environment in which the job is performed)
In factories, temperature and humidity are usually the chief considerations. In hospitals, these factors affect patient and staff comfort, while disease bacteria become yet another factor.
As an example, door handles can harbor methicillin resistant staphylococcus aureus (MRSA), and transfer it from one person's hands to another. The new Royal Liverpool Hospital in England may have silver, or more likely silver-plated, door handles [4]. Silver forms a very thin oxide layer upon exposure to air, and it is fatal to disease bacteria.
Problems may, of course, result from a combination of these six factors. Inadequate disinfection of colonoscopies shows how a combination of new equipment with lack of awareness of updated instructions exposed patients to potential harm:
The problem with the improperly disinfected Forbes colonoscopes was an extra water jet inside updated instruments bought by the hospital last fall from New York-based Olympus America Inc.
Two years ago, the U.S. Food and Drug Administration published a safety alert cautioning hospitals to clean and disinfect this auxiliary channel after every colonoscopy. The warning was issued in response to reports of some hospitals not cleaning the jet because they didn't know it was there or because they didn't use it. [5]
The reference adds that a biomedical engineer published a paper about this in the widely read Gastroenterology Nursing journal, but that problems like this keep recurring. The reason is probably that not everybody reads the journal, and that the people who disinfect the colonoscopes don't bother to read the new instruction manuals. The new colonoscopes probably looked a lot like the old ones, and the people whose job it was to disinfect them had no real reason to believe that the new items needed a different procedure.
An ISO 9001:2000-compliant quality management system does not assume that anybody reads new instructions, trade journals, FDA safety alerts, or anything else. It ensures that the people read the new instructions by informing them of the change, and then requiring them to sign a log to verify that they had read the new procedure.
Closed Loop Corrective Action
Placing blame on the nurse (or doctor) for a system-related deficiency is worse than unfair to the health care worker and detrimental to overall morale. It also allows the deficiency to go uncorrected, thus placing future patients at risk.
In industry, any serious quality problem requires closed loop corrective action (CLCA) to make sure it does not happen again. Numerous methods like the Ford Motor Company's Team Oriented Problem Solving, Eight Disciplines (TOPS‑8D), and Six Sigma's Define, Measure, Analyze, Improve, and Control (DMAIC) are available. All operate in essentially the same manner, though.
All modern CLCA approaches involve a cross-functional team of people with relevant skills. As an example, a doctor, nurse, and pharmacist might participate in a team to assess medication errors. This is because the doctor issues the prescription, the pharmacist fills it, and the nurse administers it. The three tasks are interdependent, so any solution must involve them all.
The team must define the problem clearly, identify the problem's root cause, and then develop a corrective action to fix that root cause. The corrective action is then tested for effectiveness and, if successful, it becomes the new standard for the job.
Standardization is mandatory, and this is why ISO 9001:2000 is so obsessed with "documentation." If the organization relies on word of mouth, or postings on bulletin boards, some people will do the job the new way while others will do it as they have always done it. Obsolete work instructions must be withdrawn, and everybody who does the job must confirm that they have read the new work instruction.
Since mistakes in health care settings can endanger people's lives, the system must empower and encourage everyone--including doctors, nurses, and even patients--to report anything that could conceivably lead to trouble. The hiyari or "scare report" is a vehicle for doing this.
The Hiyari or "Scare Report"
Japanese factories use a document known as a hiyari or "scare report" to report near-misses, as does the Inoue Hospital in Osaka, Japan [6]. Any mistake that is caught through "worker vigilance" is treated as if it had actually happened, and closed loop corrective action is taken to prevent any recurrences.
Suppose, for example, that someone finds an oxygen tube on the floor where it could conceivably be stepped on, or rolled on by a patient's chair, thus restricting or cutting off the gas flow. Whoever finds this should file a hiyari, and the problem treated as if it had actually happened.
Furthermore, meetings or bulletin board postings that tell nurses to "be more careful" about letting the tubes fall on the floor are emphatically not a satisfactory solution. First, no solution that requires worker vigilance is really a good one. Second, there are doubtlessly other ways in which flexible tubes can become fouled or constricted. The solution should consider, for example, monitors that detect unusual gas pressures (thus indicating blockage in the tubes). This is an example of jidoka or autonomation; the equipment is capable of sensing abnormal conditions, and of sounding an alarm when they occur.
The Allnurses discussion board [2] cites numerous examples of different medications whose containers look alike, or whose names sound alike. This is a perfect example of a case for a hiyari. The author recalls a self-directed work team in a factory that noticed that process recipes differed by only one digit, thus making it easy to enter the wrong one by mistake. The team's solution was to change the numbering scheme to make the recipes' numbers very different. While a hospital can't change the names of medications, it can implement a computer physician order entry system (CPOE) and bar codes for medication containers.
Another example would be a situation in which a nurse warns a doctor that the dosage he is prescribing is unusual or dangerous. A culture of blame would promote animosity, because the doctor doesn't want anyone to know that he endangered the patient, while the nurse might have gotten into trouble for administering the overdose. While the doctor is ultimately responsible for the decision, common sense says that he or she cannot rely on memory for the proper dosages, and also that many medications have similar names. A CPOE system would probably be of great comfort to everybody. It would immediately tell the doctor if the dose was outside the usual range, and also if the medication interacted with the patient's other medications.
The key point is, however, that a culture of blame would create a very tense situation between the doctor and the nurse. In an intelligently-managed environment, the doctor himself might file a hiyari that said, "I almost prescribed the wrong dose, and only the nurse's vigilance prevented it." The doctor is not "taking the blame" by doing this, he is pointing out just how easy it is for every doctor in the hospital to make this kind of error. The result should be a systematic change that makes the error as close to impossible as is practical.
Summary
At least four out of five medical errors are probably due not to negligence or carelessness, but to deficiencies in the system in which doctors and nurses must work. The ISO 9001:2000 standard and its health care specific modification, IWA‑1, recognize that people work in a system, and that a deficient system cannot deliver good quality no matter how skilled or careful the workers might be.
Elimination of medical errors requires closed loop corrective action for all occurrences, with near-misses being treated as if they had actually occurred. The organization's culture must encourage the identification of problems and closed loop corrective action. A culture of blame serves only to (1) discourage people from reporting problems and (2) deflect attention from the problems' root causes.
Disclaimer
Nothing in this article constitutes medical advice, which the author is not qualified to give, nor does it constitute engineering advice. Discussions are based entirely on information from the indicated references, and not on first-hand knowledge.
References
[1] Juran, Joseph, and Gryna, Frank. 1988. Juran's Quality Control Handbook, 4th ED. New York: McGraw-Hill, 17.4-17.5
[2] "7000 fatal med errors last year-where are theses nurses?" http://allnurses.com/forums/f8/7000-fatal-med-errors-last-year-where-theses-nurses-171356.html
[3]Wheeldon; Peter G. (Guildford, GB2), Kent; John (Nr. Petworth, GB2) U.S. Patent4,670,007
[4] Bartlett, David. 2007. " Blueprint for new Royal Liverpool Hospital unveiled." Liverpool Daily Post, July 24, 2007. Liverpool Echo: Latest Liverpool and Merseyside news, sports and what's on
[5] Bails, Jennifer. 2005. "Candor praised in scope problems." Pittsburgh Tribune Review, April 1 2005.
[6] Imai, Masaaki. 1997. Gemba Kaizen: A Commonsense, Low-Cost Approach to Management. New York: McGraw-Hill pp. 142-143, 273-276
