Doctors are responsible for a minority of medical mistakes in radiation therapy

The New York Times recently featured a disturbing expose of serious medical errors associated with the newest forms of high tech radiation treatment, entitled, Radiation Offers New Cures, and Ways to Do Harm. The piece is an example of excellent medical journalism, compelling stories of two individuals who sustained truly horrifying injuries as the result of treatment errors framed a detailed investigation of similar errors that have occurred in New York State.

One of the most notable features of the medical errors highlighted by the article received only short shrift, however. That is unfortunate because it is an increasing source of medical error and is rarely included in public discussion of medical errors. Of the 1264 specific mistakes identified in the article, only a small proportion were made by doctors. The vast majority of errors were made by other people: physicists and programmers who ran the machines, ancillary medical professionals who positioned the patients during actual treatment, and support staff who brought the wrong patients for treatment.

Medical errors are a very serious problem and we should be engaged in an all out effort to reduce them to zero if possible. When people think about medical errors, they tend to imagine them as physician errors that could be corrected by greater diligence. Yet many medical errors are cause by people other than doctors, including people who are not medical professionals. These errors fall into three broad categories: errors introduced by complex monitoring and treatment machinery, errors caused by ancillary medical personnel, and clerical errors.

Consider the errors attributable to machinery. Extraordinarily complex machinery is involved in many aspects of medical care. In this case, the injuries and deaths were caused by a highly specialized and sophisticated form of radiation delivery, a linear accelerator with a multi-leaf collimator. The article explains:

… [A] linear accelerator with 120 computer-controlled metal leaves, called a multileaf collimator, … could more precisely shape and modulate the radiation beam. This treatment is called Intensity Modulated Radiation Therapy, or I.M.R.T. The unit St. Vincent’s had was made by Varian Medical Systems, a leading supplier of radiation equipment.
“The technique is so precise, we can treat areas that would have been considered much too risky before I.M.R.T., too close to important critical structures,” Dr. Anthony M. Berson, St. Vincent’s chief radiation oncologist, said in a 2001 news release.

Sophisticated machinery is run by computers and computers must be programmed. The case of Scott Jerome-Parks who was severely injured by excess radiation and subsequently died illustrates how serious errors can be made:

Tasked with carrying out [the treatment] plan was Nina Kalach, a medical physicist. In the world of radiotherapy, medical physicists play a vital role in patient safety — checking the calibration of machines, ensuring that the computer delivers the correct dose to the proper location, as well as assuming other safety tasks…
On the morning of March 14, Ms. Kalach revised Mr. Jerome-Parks’s treatment plan using Varian software. Then, with the patient waiting in the wings, a problem arose, state records show.
Shortly after 11 a.m., as Ms. Kalach was trying to save her work, the computer began seizing up, displaying an error message. The hospital would later say that similar system crashes “are not uncommon with the Varian software, and these issues have been communicated to Varian on numerous occasions.”
An error message asked Ms. Kalach if she wanted to save her changes before the program aborted. She answered yes.

Ms. Kalach did not know that the computer had not saved the treatment instructions that she had programmed. As a result, Mr. Jerome-Parks received a massive overdose of radiation:

The investigation into what happened to Mr. Jerome-Parks quickly turned to the Varian software that powered the linear accelerator…
When the computer kept crashing, Ms. Kalach, the medical physicist, did not realize that her instructions for the collimator had not been saved, state records show. She proceeded as though the problem had been fixed.
“We were just stunned that a company could make technology that could administer that amount of radiation — that extreme amount of radiation — without some fail-safe mechanism,” said Ms. Weir-Bryan, Ms. Jerome-Parks’s friend from Toronto. “It’s always something we keep harkening back to: How could this happen? What accountability do these companies have to create something safe?”

The software malfunction was one among many similar highly technical errors. Indeed more than half of the identified medical errors were related to programming the linear accelerator. Yet at the other end of the spectrum of sophistication, there were disturbingly large numbers of errors as well. In 174 instances, the wrong location was treated or even the wrong patient was treated. In 66 instances, staffing shortages or miscommunications resulted in treatment errors.

In total, at least 621 patients were harmed by medical errors, but ultimately only 6% of the errors were attributable to the physicians caring for the patients. The New York Times article on radiation treatment errors sounds an alarm not merely about a specific, highly technical form of treatment. It also raises serious questions about errors caused by ancillary medical personnel and even support staff. Such errors are inexcusable, and will require a different approach than conventional medical errors, an approach we must start working on immediately.

Amy Tuteur is an obstetrician-gynecologist who blogs at The Skeptical OB.

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Comments

http://pharm-aid.blogspot.com Pharm Aid
It’s interesting that some physicians can walk away with a clear conscience. Does delegating the action absolve the physician of all responsibility? Evidently, in the world of Dr. Tuteur, it does.
If a technician sets a protocol on the machine and then the physician walks up and activates the scan or therapy, in Dr. Tuteur’s world, that’s not a physician mistake. Despite the fact that a physician failed to double-check the activity. Ditto for the wrong site errors. Ditto for the wrong patient errors. Ditto.
Delegating preparation does not negate the physician’s role in ultimate harm. Is it soley the physician’s mistake? Clearly not, but they have some responsibility for not ensuring accuracy.
Of course, some physicians will continue to believe that they have never made a mistake (and never will)… I guess that’s what we’re seeing here.
http://www.psqh.com Susan Carr
Effective safety improvement work is inclusive, multidisciplinary, very careful about accountability, and—for good reason—reluctant to assign blame. Labeling medical errors as “inexcusable” is counterproductive and may lead to unfortunate events such as the conviction and incarceration of Eric Cropp. While I understand that physicians are sometimes targeted unfairly, lashing out at others will only make things worse. The malfunctions described in Dr. Tuteur’s post and the New York Times’ series are disturbing. Correcting these problems will require investigation, teamwork, transparency, and courage—none of which are served by finger-pointing of this sort.
http://www.futurewaredc.com Chuck Brooks
Safety regulations are still written in blood.
Healthcare Observer
What an unpleasant article. In any decent hospital – and healthcare system – it is a senior radiation oncologist in charge of a multidisciplinary department who is responsible for standards. The Times articles are an indictment of fragmented American healthcare, abdication of physician responsibility, and rush and greed to implement new technology – and not the failure of any group of professionals further down the food chain.
http://fertilityfile.com IVF-MD
It’s horrible the harm that was done in these cases and certainly no less horrible than the many other ways that people are killed and harmed in the world daily.
The big question to ask is “By what criteria would lawyers define something to be an EXCUSABLE error?”
http://www.skepticalob.com Amy Tuteur, MD
“If a technician sets a protocol on the machine and then the physician walks up and activates the scan or therapy, in Dr. Tuteur’s world, that’s not a physician mistake.”
What makes you think that the physician activated the machine?
The point of this post is that sophisticated medical treatments are being delivered by technicians and others and oversight is extremely poor. In order to reduce medical errors it is absolutely critical that we learn who commits the errors and how proper oversight could eliminate them. Although it may be satisfying to blame doctors, it isn’t going to save any patients if they aren’t the ones at fault.
http://www.skepticalob.com Amy Tuteur, MD
“Labeling medical errors as “inexcusable” is counterproductive”
I disagree. Radiating the wrong patient is inexcusable. There are no possible mitigating circumstances. Yet no one is held accountable for such inexcusable errors. The hospitals have every incentive to push patients through treatments as quickly as possible. Many are insulated from any consequences of poor oversight because of charitable immunity; malpractice payouts are capped at very low amounts.
I have a modest proposal for improving oversight in hospitals:
For every inexcusable error like radiating the wrong patients, the hospital executives should personally be fined tens of thousand of dollars. That would quickly end inexcusable errors like radiating the wrong patient, because executives would immediately hire more qualified support staff and institute more aggressive monitoring of performance.
http://www.skepticalob.com Amy Tuteur, MD
“It’s horrible the harm that was done in these cases and certainly no less horrible than the many other ways that people are killed and harmed in the world daily.”
No, but it was 100% avoidable and that’s what makes these errors inexcusable.
http://pharm-aid.blogspot.com Pharm Aid
@Amy: “The point of this post is that sophisticated medical treatments are being delivered by technicians and others and oversight is extremely poor. In order to reduce medical errors it is absolutely critical that we learn who commits the errors and how proper oversight could eliminate them. Although it may be satisfying to blame doctors, it isn’t going to save any patients if they aren’t the ones at fault.”
I absolutely agree that we need to reduce errors. The way to do that is to recognize that healthcare delivery is inter-dependent. And that physicians have a role in BOTH the delivery of their own care as well in the oversight of their staff. On OB has responsibility for herself as well as others directly involved in the care of her patients when following her care instructions.
Articles attempting to shield physicians from any accountability, run contrary to actually wanting to reduce medical errors. This article is a defensive play for physicians (the AMA will thank you), but doesn’t demonstrate any interest in improving care or reducing harm (only shielding doctors from accountability).
Given your background and some of the patient outcomes you have personally written about on your blog, I guess I can understand why you’ve come to this perspective.
ninguem
I love all the talk about how doctors have to learn to be team players, all the paramedical people want independence.
But not the responsibility. When something goes wrong, it’s always the doctor’s fault.
http://www.skepticalob.com Amy Tuteur, MD
Pharm Aid:
“And that physicians have a role in BOTH the delivery of their own care as well in the oversight of their staff.”
But many of these personnel are NOT their staff and the physicians have NO CONTROL over these people.
For example, if I order an IV medication for my hospitalized patient and the pharmacy tech mixes up the wrong dose, there is NOTHING I can do about it. I’m not there; I’m not giving the medication; I have no way of knowing what the pharmacy tech did’ and, most importantly, I can’t fire the pharmacy tech if I find out he’s responsible.
The pharmacy tech is not “my staff” anymore than the cafeteria workers are “my staff.” I can’t hire them. I can’t fire them. I can’t mandate certain minimal standards. I can’t oversee their work. I can’t do a blessed thing about their mistakes. They work for the hospital and only the hospital can do those things. Yet, the hospital has virtually no incentive to properly monitor these personnel.
It would be wonderful if doctors could exert some control over the many ancillary personnel who are involved in patient care, but that is simply impossible.
As I said above, it may be satisfying to blame doctors for these mistakes, but they have no control over these mistakes. The sooner people realize how others contribute to their care, and how little oversight of these people exists, they can demand appropriate protections.

Healthcare Observer
Amy, I think you misunderstand. A radiation oncologist must have responsibility for the delivery of radiation. This is not the same as formulating a drug.

student
Actually, I think the analogy does have merit. Like drug preparation, radiation delivery after initial prescription is largely handled by the staff physicist and dosimetrist. Yes, the radiation oncologist takes ‘packaged’ responsibility for the patient’s care and signs off on the plan as does an IM in a hospital, but errors in execution do occur due to dosimetrists, rad therapists, and even the machines. It benefits noone to ignore the systems errors caused by the lack of standardization of training or oversight on the non-physician team members. This is what the articles in NYT and Dr. Tuteur point out. It is not a sandbagging effort but simply one to come in line with what already happens in other arenas of team care (ie: better tracking of error prone rad therapists who move state to state like with physicians and nurses; better standardization of accreditation of dosimetrists; etc.). I am not sure anyone is really disagreeing here over that core issue. Instead, with all due respect from a lowly student, Pharm Aid may be focusing too closely on a piece of the article (physician liability) to glean the overall point.

http://www.skepticalob.com Amy Tuteur, MD
“A radiation oncologist must have responsibility for the delivery of radiation”
What does “must have” mean? Do you think the radiation oncologist personally supervises each individual treatment during the treatment course?
Healthcare Observer
Amy and ‘student’,
I’m based in Europe and have visited many cancer facilities as part of my job – the idea that the head of a radiation oncology department in a cancer centre or teaching hospital does not have responsibility for the delivery of treatment would be ludicrous. That means training, teamwork etc – and with the introduction of new technology that effort has to be doubled and redoubled as the potential for errors has risen sharply. New radiation technologies such can take months to train in and plan treatments through simulation. Of course the head of department does not personally treat everyone – but they are responsible and all the staff have line reporting to the head. If this is not the way it works in the US then it should – what good is a radiation oncologist who does not have a team they are in control of and can trust through their own supervision.
http://www.skepticalob.com Amy Tuteur, MD
“If this is not the way it works in the US then it should – what good is a radiation oncologist who does not have a team they are in control of and can trust through their own supervision.”
Excellent question!!!
As a salaried practicing obstetrician, I had NO control over any other personnel besides myself. I could report people whose performance was substandard, but usually nothing happened, no matter how grievous the error.

Healthcare Observer
‘As a salaried practicing obstetrician, I had NO control over any other personnel besides myself.’
Yes, but were you all working under a head of obstetrics? That’s the key issue. If you were the head, then that’s a real problem if you had no control. If there was no head, that’s a real problem too.

student
The argument isn’t whether the head of a department can exercise control over its members–that is a given. Rather, the issue would seem to be the perceived lack of ability of an individual physician to institute measures of redress for fault that is not their own yet for which they are in the end responsible and liable (as they should be as a ‘leader’). Namely, the lack of training regulation and performance registries for ancillary staff in rad/onc complicates the ability of the physician to predict or permanently address errors by non-physician personnel (again this is the major point of the articles).
Your focus on whole departments, an area of responsibility assignment upon which we agree, misses the point of care issues facing a physician’s ability to manage or even pick his/her team. I doubt anyone ascribes to the idea a physician has no role in responsibility for such errors as discussed. To my ears, the call in these articles is not to avoid physician responsibility but to empower the physician to at least do more than take the fall when something goes wrong ie: give them the regulatory and institutional support to actually supervise their team effectively.

http://www.skepticalob.com Amy Tuteur, MD
“If you were the head, then that’s a real problem if you had no control.”
The head of obstetrics had minimal to no control either. The personnel work for the hospital. In some hospitals there are unions that get involved in any complaints about their members, making it even more difficult to discipline employees for infractions. Department heads can’t even get rid of terrible doctors who work under them, even though they technically have supervisory power over them. It is virtually impossible to remove a doctor, no matter how incompetent.
I know that people really want to believe that doctors have control over these things, but they don’t; this is a source of terrible frustration for doctors. Unless and until steps are taken to make hospitals accountable for the employees they hire, there will be no reason for them to supervise and discipline them properly.

cheryl
As an electrical engineer, I was responsible for using computer design and simulation tools that required extensive validation before they would be released into production use, because a tape-out (integrated circuit design database) that was based on faulty tools was not just worthless but had the potential to cost millions in both wasted IC lithographic masks and missed market windows.
If any released tool I was using crashed on a regular basis or gave me any indication that its results were off, I would personally test it against known good tools and primitive test cases to prove or disprove the tool, and if I found that it was not functional I would refuse to use it until it was repaired, even if it cost me my job, because to do otherwise would be unethical. I would be ignoring the interests of the shareholders if I exposed them to that kind of risk without double-checking my work, regardless of who was ‘at fault’, because the buck ultimately stops with the person who is doing the work.
In fact I did put a stake in the ground on several occasions, and in one case where management overruled me when a change of simulation tool found a design weakness that was originally unknown, we went ahead with the chip anyway, then we wasted six months beefing up the circuit board design and jacking up the power supply to compensate for a chip with a weak high-speed clock buffer. I was ultimately terminated in a layoff when my corporation was bought by the competition, so I won no friends by doing the right thing, but I would challenge authority again even if it profited no one because to do otherwise could potentially cause even worse problems for more people than just me, especially the next time a similar issue arose.
That is the whole issue. If there are no people in medicine with ethics that approach the ethics of electrical engineers, then we may as well acknowledge that our entire system of medicine is corrupt.
People have to be willing to take a bullet from the firing squad if they want to be protected from shrapnel when the doo doo hits the fan. The price of public safety is personal risk. As long as we are all looking out for number one and keeping our heads down we will all be exposed to the externalized costs of collateral damage. It starts and stops with us as individuals.
I have not seen doctors as a class doing very much about these types of problems in the United States. Here we have doctors complaining about how dangerous it is to practice medicine, when in fact doctors make more money than most other people and have far more power and prestige too. Meanwhile there is carnage in the operating theater as doctors install defective appliances and use known inferior methods simply because the management approves and the jury demands it. As long as doctors continue to think of themselves as powerless, people will die needlessly.
Sometimes to ensure safety it is necessary to take a risk. Do what you know is right, and convince your colleagues to do the same, and eventually the problem will be solved. No major problem was ever solved by legislative fiat. It is always a grass roots effort.
Healthcare Observer
‘The head of obstetrics had minimal to no control either. The personnel work for the hospital.’
Well, personnel such as nurses often report through different managers in European hospitals too. But in the case we’re discussing – radiation oncology – the key personnel such as medical physicists will almost certainly be part of a department headed by a senior radiation oncologist, who in turn sits alongside a senior medical oncologist and surgeon in a multidisciplinary team (with one of these often rotating as overall oncology head). There have been instances where European hospitals (such as a smaller regional hospital) have got radiation wrong but this usually becomes a huge national scandal and leads to radical revamp of national standards, eg in France recently.

Primary Care Internist
ninguem said it right.
Analogously, should the physician who ordered a medication correctly be responsible if either the wrong dose or wrong med (or wrong patient) is administered?
The media portrays errors (eg. Dennis Quaid’s twins at cedar sinai, or was it UCLA?) as “medical” which gives the misperception that a doctor was to blame. In my experience most errors are due to either nursing or clerical errors. But really they are SYSTEM errors ie. either a lack of systems in place to avoid simple but catastrophic errors, or too many inefficient systems in place that ultimately create confusion (computerized order entry is a good example of the latter).
http://fertilityfile.com IVF-MD
Dr. Tuteur: No, but it was 100% avoidable and that’s what makes these errors inexcusable.
In the complicated process of delivering medical care, there could be 1000 different ways that things could go wrong. One can always isolate ONE item and say that it could have been made 100% avoidable.
Horrendous debilitating fourth degree tears are 100% avoidable if you deliver everybody by C-section. Term stillbirths from cord-accidents are 100% avoidable if you hospitalize and monitor every pregnant woman after 30 weeks.
In this rad onc scenario, I am in agreement that there was a big problem, but my point is more general in that every ounce of attention and care that is directed towards one aspect of the entire medical care process necessarily subtracts from the attention, time and money that can be dedicated to another aspect. The goal is to optimize the balance.
Looking at something in isolation, one might champion a particular mandate or regulation that will result in one life saved every five years. But if the costs are prohibitive, then that means you are cutting into resources that could have been used to save 100 other lives in other ways.
Dr. Tuteur, I’m not saying that you adopt this position, but rather I’m making a general appeal to everyone to think with an open mind that every action has far-reaching consequences. I’ll use a good example. The intense inflexibility of the FDA in the new-drug approval process might minimize the release to the public of drugs that have potential harmful side effects. But the tremendous added cost and barriers have undoubtedly resulted in depriving this country of many still-undeveloped life-saving drugs.
Again, we need to be smart and look at the big picture rather than look at one thing in isolation.
By the way, my comments are not aimed specifically at the rad-onc incident, but rather at the comment about something being “100% avoidable”.
http://www.skepticalob.com Amy Tuteur, MD
“every ounce of attention and care that is directed towards one aspect of the entire medical care process necessarily subtracts from the attention, time and money that can be dedicated to another aspect. The goal is to optimize the balance.”
There are many situations in medicine where that is the case, but basic errors like radiating the wrong patients are in a different category. Such errors are not difficult to prevent, nor are any expenditures required.
Zach
What’s shocking to me is how much this sounds like the series of accidents with the THERAC-25. Again, we have buggy software leaving treatment instructions in an inconsistent state and leading to massive overdoses. Have the device makers _still_ not learned to put hardware interlocks on anything that can deliver lethal doses of radiation? At the very least, alarms should sound if you try to activate the beam with all the leaves wide open. That being said, the buck has to stop with the person whose finger was on the button, and I’d say it’s the physicist delivering the radiation in this case. Varian deserves a whopping share of the blame, but I can’t see my way clear to excusing a failure to re-check the dosing instructions after a software crash.
http://fertilityfile.com IVF-MD
Here are a few questions that may or may not have already naturally popped into your head.
If these radiation therapy places are really that terrible, messing up left and right as indicated in the article, what is preventing someone really meticulous and efficient from opening up competing centers, hiring the most competent ancillary staff and running a really top notch operation?
Is it because there are artifical restrictions being enforced so that even if someone (let’s say a top-notch group of Swiss or Japanese physicians) would be able to put together a better quality, more mistake-free center, they would still not be permitted to do so by the protective licensing boards?
Is it because there’s little incentive to do so, meaning that the patients don’t really have the mindset to be smart shoppers and carefully choose a quality center (since they are not paying for it and they are trusting some third party to protect them and make decisions for them)? So what’s the point of building a better center, because even if you continue to make mistakes, you’ll still get plenty of business?
Is it because of the lack of transparency, meaning even if a patient really wanted to compulsively choose the best center with the best track record, there is no way for him/her to access truthful information?
Another question: What was the harm suffered by the physicians in charge or the techs who messed up? Did they lose their licenses? Did they get publicly flogged or shocked with high voltage Tasers? Or did they merely get a slap on the wrist and have somebody else foot the bill for their mistakes.
This brings up the next question: Does the fact that frivolous lawsuits are so easy to file clog up the system and desensitize people to effectively punish the truly justified suits such as in this case?
Again, I have my own conclusions and I welcome you to think critically and formulate your own opinions on this.

Healthcare Observer
Radiation oncology is not something you can outsource like laser eye surgery. It’s one of the pillars of comprehensive cancer care and many centers are active in oncology research as well. A head of radiation oncology works alongside heads in other specialisms and below him/her treatment and clinical research takes place. Radiation oncology brings together probably the most complex and broad set of subspecialisms in medicine so lack of integration and clinical chain of command is really not a good idea, to put it mildly.

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