Henry Ford recognized that quality and efficiency in mass manufacuring could be improved by breaking the process down into bits and pieces. And you could have any color car you wanted as long as it was black. The digital computer facilitated customization of automobiles while retaining many of the virtues of the assembly line. In the case of quality health care in the digital age, how closely does the production process resemble the Ford-Deming paradigm? Are there at least parts of health care that can be improved by assigning patients to pathways and protocols?
The answer is a qualified "yes" but not without the risk of unintended downside risk. At least three dangers lurk. First, piece work inevitibly leads to fragmentation of both function and responsibility. Second, protocols can be subsituted for thought and judement with errors resulting. Finally, opportunity costs are difficult to measure as time and resources are diverted to rote work.
The team approach to health care, in many instances, actually increases fragmentation and can lead to poor decision making. Especially in the hospital, scores of individuals can be involved in a single patient's care. Gone (for the moment at least) is the concept of primary care. The primary care physician has been replaced in the hospital by specialists with geographic names: er doc's, intensivists, hospitalists. These physicians arrange themselves in groups with rotating call schedules. The "electronic" medical record is to compensate for the fragmentation that results from all these patient handoffs.
Fragmentation is not the only potential pitfall in modern piece work team medical practice. The team often has no leader. Each member focuses on his or her piece of the product. If there is a hole in the team grid, no one specificially has the responsibility for being vigilant in searching for that hole. This can result in the medical equivalent of selling a car without brakes.
Second, quality pathways and protocols too often are subsituted for thought and judgement and are applied by rote, sometimes inappropriately. Quality medical care is always custom made for each customer. Pathways and protocols can facilitate customization. Pathways and protocols are often likened to a pilot's landing check list. But each check list is specific to the aircraft being flown and a finite and reasonably small total number of aircraft models exist, and runway use rules are nearly universal. Certain actions, like deploying the landing gear, are common to nearly all aircraft. Yet this crucial step is still occasionally missed by experienced pilots.
Certainly a surgeon who performs hundreds of elective knee replacements every year can perform more efficiently with a team and by following a flexible pathway. Two real life anecdotes illustrate the downside of protocol based medicine.
A patieint is admitted to the hospital for severely low blood platelets and has a very high risk of bleeding. The first procedure done routinely on admission is a nasal swab for detection of of methicillin resistent staph. The carrier state poses no immediate threat to the patient, but may represent a "public health" problem. The nasal swab is followed by a nose bleed which proves difficult to control and causes considerable patient distress. The test is positive and the next day the patient is informed that he requires an antibiotic appplication to abolish his "MRSA" nasal carrier state. Another nose bleed ensues.
A patient with a mechanical artificial mitral heart valve develops abdominal pain and is admitted to the hospital. Her physicians are concerned that an operation may soon be required. She is on the "blood "thinner" coumadin. She has impaired kidney function and difficult veins to access for blood tests. After a discussion between a heart and blood doctor, a determination is made that the coumadin should be reversed and "full" anticoagulation with a shorter acting blood "thinner" be substituted. The patient is obese and had not been eating or drinking in the prior 24 hours. Her "lean body weight" and "steady state" kidney function could only be roughly estimated. The thinner to be employed is dosed based on a formula that uses lean body weight and steady state kidney function.
The blood doctor writes a lengthy discussion of the issues and his goals in the chart progress notes and orders his best estimate of the proper dose. When he returns the next morning, he finds that a totally different and inadequate dose has been given at the direction of the pharmacist based on a calculation of kidney function and the patient's actual weight.
Unfortunately, the "routine" protocol actually employed was for prevention of blood clots in the legs. What was wanted was full dose anticoagulation for a patient with an artificial heart valve. The prevention protocol used works well for its purpose for patients with known stable kidney function and reasonably well estimated lean body weight. These assumptions are often fulfilled in patients undergoing elective surgery, but not so often in acutely ill patients with multiple medical conditions.
These anecdotes serve to raise awareness that well meaning protocol interventions made in the name of quality do not come free from risk. And little is known about the interactions among protocols or the net effect of their routine application on all meaningful end points.
Finally, the opportunity costs of protocol based medicine are unknown. The aggregate time needed to isolate some patients to protect the rest of the hospital community is substantial. Does such isolation actually achieve the goal? If it reduces risk, is the magnitude of benefit sufficient to offset the time spent. Or would that time be more productively spent elsewhere, such as in better communication between team members? Proponents like the IHCI argue that solving the issues raised in the "100,000 Lives Campaign" are important and that interventions like the "simple" ones they propose are effective and inexpensive. Near universal agreement exists for the first predicate of importance. A small minority wonders about the latter claim of proven efficacy.
Indeed, much of the scientific methodology of quality control and improvement in medical practice has not yet been invented. Without a standardized and validated scientific method for measurement of meaningful outcomes we will remain in a pseudoscientific world characterized by herd mentality and expensive fruitless stampedes. At times it may be better to curse the darkness than to light the wrong candle.
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