Traditional industrial QI does not work in primary care. A recent publication brilliantly makes this case on both theoretical and practical levels ;-).
On a theoretical level, primary care is best thought of as a complex adaptive system, not a simple linear mechanical system. Think of complex adaptive systems as kind of being like a series of tipping points with lots of players in the environment. Relationships between the players are complex. Big changes can occur with small perturbations of the system and large perturbations can cause little change.
Knee replacement surgery is a great example of a linear mechanical system. Antibiotics should always be given before the surgery, the surgery should always occur in the same sequence, and post-op blood clot prevention should always be ordered. The patient today, the patient tomorrow, the patient in another state, all will benefit from the same service provided the same way each time. In this case, traditional QI approaches such as PDSA cycles are totally appropriate and produce similar improvements in outcomes in the same way the traditional QI approach improves the quality of a Toyota product. How can we insure that the patient always gets her antibiotic prior to incision? Hard wire that step into the process.
In contrast, if a family physician sees a patient in his clinic with an elevated blood sugar level and advises the patient to start taking insulin, what will happen next? Anything. The next time the physician sees the patient the sugar could be anything from dangerously low to even higher than before. The same clinical situation in a different patient seen the same day could result in a wildly different outcome. The same patient having this step repeated a year later could have a completely different outcome. The reasons for this are the myriad forces all family physicians understand: dozens of social determinant barriers, co-morbidities, quirky patient beliefs, and so on. These are example of non-linear complex processes.
The authors give examples of how care processes are different between linear mechanical and non-linear complex processes. They are different by the complexity of the process: linear processes are simpler with fewer variables to control that are also easier to measure. They are different by how standardized a process should be: in linear processes antibiotics should always be given before an elective major surgical case. Complex processes should not be standardized: chest pain in a healthy 18-year old should be managed differently than chest pain in a 72-year-old diabetic hypertensive smoker. They are different in how the processes are controlled: a linear process often involves a human who has essentially been turned into a machine by virtue of being rendered unconscious. Complex processes are driven by a milieu of forces including unique patient beliefs and priorities, socioeconomic forces, and the external environment.
The authors demonstrate that the outcome goals are different between mechanical and complex processes. In a linear process, the goals are not influenced by co-morbidities or other factors: the hip replacement surgery happens the same way whether the patient has 5 chronic diseases or none. In a complex process, one patient with metastatic cancer might choose another round of toxic chemotherapy while another chooses hospice, and yet another chooses an unproven alternative treatment. In a linear process, the goals are also clear in that the doctor, hospital, and patient all agree on the definition of a successful outcome: a patient who is successfully extubated from mechanical ventilation. In a complex process, the goals may be vastly different between doctor and patient: a patient with high blood sugars declines to start recommended insulin to reduce her blood glucose level because of concerns about the affordability of the medicine and a belief that insulin killed her favorite aunt. In a linear process, the timing of the outcome goal is not in question: every time an elective surgery occurs a list of interventions should stick to a fairly rigid schedule. In a complex process, the timing of a desired goal may be negotiated to come at a nebulous date in the future: the patient who just lost her husband will restart her new exercise program at some date in the future when she doesn’t feel like all the energy has been drained from her body, if ever.
For the last examples, consider this comparison. Doctor A works in a upper middle income neighborhood where every patient has health insurance and there are 2 Whole Foods within 2 miles of his clinic building. His diabetic patients’ average hemoglobin A1c is 7.4. Doctor B works in a Federally Qualified Health Center. All of his patients are poor. Many are undocumented immigrants. His diabetic patients’ average hemoglobin A1c is 8.8. Who reading this believes that these data mean that Doctor A is a higher quality doctor than Doctor B? No one with any sense.
The authors show how the current obsession with quality scorecards are wholly inadequate for family medicine. First, there are no adequate risk-adjustment tools to correct for the previous example. Studies have shown that the same doctors doing the same work in a private well-insured hospital and a safety net hospital are ranked as being high quality doctors in the former and poor quality doctors in the latter. Second, the existing six sigma mentality transferred to healthcare by the early proponents of QI/PDSA means that the numerical target should always be to strive to achieve the stated goal 99.99966% of the time. This is a ludicrous target for everything in primary care. Third, quality scorecards inadequately reflect the breadth and depth of family medicine. If an orthopod only does hips and knees, then a scorecard of his hip and knee infection and blood clot rates mostly reflect the quality of his work. If a family physician is scored on even 20 different measures, that leaves off the report approximately 600 other symptoms and diseases she manages. This is also ludicrous.
In the current belief system of the pundit/political class, they want to “pay for value, not volume.” In Medicare’s current Common Core Measures for Primary Care, they have come up with mostly a list of these simplistic single-disease metrics that feed into a “value-based” scorecard. Nothing could be farther from the truth.
All they are about to do is to incentivize family physicians to dump the most vulnerable patients from their roles. The poor patients, those with mental illness, difficult family situations, and a history of poor life choices will be cast out of the primary care system and thrown back to the revolving ER door system: the worst place these patients can be. One gets what one pays for, and Medicare is about to pay for this horror.
A high-quality family physician is not one who mindlessly follows simplistic single-disease recipes. In my world, we call this practicing like a nurse practitioner. A high-quality family physician often achieves the best care by NOT doing what the cookbook says. In contrast to the horror Medicare is about to foist on the American people, a high-quality family physician says, “I will take care of you no matter what. It doesn’t matter your background, skin color, social status, mental fitness, education level, or quirky beliefs. My door is always open. We can even disagree on what we think the best path is for you, but I will always respect your wishes (except for the rare times where my calling demands that I really need to protect you from yourself). We will walk together on your life’s journey and I will never abandon you.”
That’s what a great family doctor sounds like, and no simple-minded mechanical linear report card will ever figure this out.
I really enjoy reading your newsletter. I would like to share with you what happened to me when I had Da Vinci Robotic Surgery.
Jerry F. Queen
253 Pinch Ridge Road
Elkview, WV 25071
Telephone: (304) 965-7604
Email: jerryqueen1@frontier.com
Re: Da Vinci Robot is a very dangerous operation device!
Dear Sir:
I am writing a letter to you explaining just what happened to me when I was operated on via Da-Vinci Robot. First of all, my Urologist/Surgeon (Mr. James Tierney) told me and my family that I had developed prostate cancer and that I would have to have my prostate removed because on the Gleason Scale reading of 6. Dr. Tierney said that he recommended using the Da-Vinci Robot because it would do a better job and that it would allow him to see everything on a big screen so that he would be able not to cut any nerves or blood vessels that would affect me from having sex and that it would prevent me from having incontinence. Dr. Tierney convinced me and my family that the Da-Vinci Robot was the way to go and that my family could pick me up at the hospital the next morning. When my family came to get me, I was in a bad way. I could not stand, eat, move and I was in so much pain. The nurses had put on me a drainage bag and about every two hours the bag would fill up with bright red blood just like if I had just cut myself. Drainage would not be the same color as pure blood. Dr. Tierney told my family that I would not be going home because of complications during surgery. Dr. Tierney said that it happens sometimes during robotic surgery. My hospital records shows that during the first week in the hospital the nurses had given me three pints of whole blood and two weeks later, the nurses had to give 3 more pints of whole blood. I became weaker and weaker. I could not walk and I could not eat and I was miserable. Instead of being in the hospital for one night, I ended up being in the Hospital from March 3, 2009, until March 28, 2009, almost a month. I was slowly bleeding to death internally and no one at the CAMC (Memorial) Hospital had caught the fact that I was filling up the so-called drainage pouch every two hours with my life’s blood. I was bleeding internally and no one caught it. One night about 2:00 a.m. my cousin was in my room with me and I looked at him and I told him that I loved him and for him to tell my family that I loved them. I told him that I was dying because the room was becoming darker and darker. He took off running to get a nurse. The nurse checked my blood pressure and it was 42/36. The nurse immediately called the blue rescue team to resituate me. The blue team worked on me for over an hour and they ended up giving me 5 pints of whole blood. All of the blood that was in the drainage bag was my life’s blood and the nurses would simply write down how much fluid was in the drainage bag and then poured the contents down the commode. The nurses were literally pouring my life’s blood down the toilet. There were two Interns that helped Dr. Tierney with the Da-Vinci Robotic surgery on the removal of my prostate. Last year I saw one of the interns that had assisted with my Da-Vinci surgery and his name is Dr. Samuel Deem, DO and he has his own Urology practice now. Dr. Deem and I talked about what had gone wrong during my prostate surgery using the DA Vinci Robot. Dr. Deem said that Dr. Tierney (the Da-vinci Robot surgeon) said that he thought that they were going to lose Mr. Queen because of internal bleeding. Dr. Tierney never came to see me after my Robotic surgery and he never told me or my family what went wrong. Only his interns came to see me and they never said anything about what had gone wrong during my Robotic surgery. Dr. Tierney did nothing to rectify my internal bleeding. Dr. Deem said that he could tell me a lot more, but he was afraid that Dr. Tierney would sue him. I am not certain that Dr. James Tierney is certified to perform Robotic Surgery or not. The way that my surgery was bungled, makes me feel that he is not qualified to perform Da Vinci Robotic Surgery. I guess after he had performed the surgery and he knew that things went bad for me, I never saw Dr. Tierney again while I was in the hospital for almost a month. I saw the Interns. Dr. DeFade & Dr. Deem.
Dr. Deem said that Dr. Tierney thought that he had fused some blood vessels together and he thought that they were fused together but in fact they were not fused together. Because the blood vessels were not fused together caused me to lose more than 12 pints of whole blood from March 03, 2008 through March 25, 2008, and I had to be re-admitted and I had to stay two more weeks. Dr. Deem also said that Dr. Tierney seemed to lose control of the DA Vinci Robot when he tried to remove it from my body. After three weeks in the hospital, I was allowed to go home, however, I had to re-admitted the next day because I was fainting, nauseated, could not eat and I was hurting badly. I was readmitted to the hospital and I remained in the hospital another week, I started feeling better and there was not very much drainage or blood in my drainage bag.
I want you to know that I almost lost my life by having DA Vinci Robotic surgery to remove my prostate. Dr. Tierney had said that using the DA Vinci Robot would allow him to see better and that he would be able not to cut any blood vessels or connecting tissue that would keep me from having erections or incontinence. Everything that Dr. Tierney said was a complete lie because I ended up in the hospital about 30 days instead of only one night. I also almost bled to death, because Dr. Tierney and the nurses did not know the difference between whole blood and drainage. If my cousin had not been present at 2:00 a.m. then I would have died because I had lost three pints of blood during the first week after my robotic surgery and then two weeks later the nurses had to give me five more pints of whole blood. Dr. Deem and Dr. DeFade (Dr. Tierney‘s Interns) told me in the hospital that they had assisted with my operation and said that Dr. Tierney seemed to have lost control of the Da-vinci Robot when he tried to remove it from my body and that caused the Da-vinci Robot to cut blood vessels, surrounding tissue and other organs. After I was able to go home I had incontinence really bad. Urine would constantly drip from my penis and Dr. Tierney said that he knew a Doctor in Columbus, Ohio that has a new procedure that would stop my incontinence. I agreed to have the incontinence operation which entailed using mesh to raise my bladder to a higher level and that was supposed to stop my incontinence. This operation was a total failure. I still continued to have incontinence problems just like I had before the incontinence operation. Shortly after I had the prostate surgery using the Da-Vinci Robot my family Doctor, Dr. Robert Johnson told me that I had two hernias, one on the right side and one on the left side. I did not have any hernias before I had the Da Vinci Robotic surgery to remove my prostate and after I had the incontinence operation to supposedly fix my incontinence problem. I think that losing control of the Da-vinci Robot when Dr. Tierney was trying to remove the Da-vinci Robot from my body and the Robot started back up via itself did cut the tissue between my stomach and intestines thus causing me to have double hernias. I have become completely impotent and the surgeon that performed my Da Vinci Robotic surgery to remove my prostate (Dr. Tierney) said that by using the Da Vinci Robot would allow him to see better and allow him to do a better job and that it would not cause me to be impotent. Dr. Deem referred me to another Urologist (Dr. Joshua Lohri) on August 2010 I had an appointment with Dr. Joshua Lohri and he said that he could fix my incontinence problem by inserting a new incontinence device inside of me and all that I have to do is to push a button and the artificial device would allow me to urinate as normal and after 70 seconds the device starts to close automatically and there is no incontinence. I told Dr. Lohri that I would get back to him at a later date because I had to have two hernias operations before I would consider the incontinence device operation. I had one hernia (supposedly repaired on the right side) by Doctor Kyer. When I went back to my family physician (Dr. Robert Johnston) he checked my right side where I had hernia surgery. Dr. Johnston said that he thought that I said that I had my right side hernia fixed. Dr. Johnston said that my right hernia was still there. I then went to another Doctor (Dr. Tilley) I had the two hernias operated performed by Dr. Tilley and after I recovered from hernia surgery I had the incontinence device implanted in me by Dr. Lohri. The incontinence device works fine and you would never know that I ever had incontinence. Also, Dr. Lohri said that there are new devices on the market that would allow me to resume having sex if I was interested. I told him that I was very interested in this latest penile in-plant and Dr. Lohri operated on me on May 6, 2013, and because so much damage was caused to me by the use of the Da Vinci Robot surgery that the penile implant does not work for me. I have lost the ability to ever have sex for the rest of my life. Also, I have had three hernia operations (1 By Dr. Kyer and two by Dr. Tilley) repaired. I asked Dr. Tilley if he thought that by having my prostate removed by the use the Da-vinci Robot and the surgeon lost control of the Da-vinci Robot if the Da-vinci Robot could have cut my intestines and caused my internal bleeding and my double hernia’s, his answer was it is completely possible because I did not have any hernias until after I had the Da-vinci Robotic surgery to remove my prostate. In all, I had four hernia operations, two incontinence operations and a penile implant operation that does not work because of the damages that the Da Vinci Robot caused during my prostate surgery. Having the Da Vinci Robotic surgery has caused me to have 7 more operations because of the defects that were in the Da Vinci Robot itself.
Intuitive Surgical Supplies is the manufacturer of the Da Vinci Robot surgical device that is used to perform surgeries of various types on a great number of people and it does have defects and flaws in it that causes people to die, have excess bleeding, cuts, nicks other tissues and blood veins and damages other organs and is not 100% controllable by the surgeon that uses the Da Vinci Robot. Just about every day I hear on the news or read in the newspapers where someone who has surgery via the use of the Da Vinci Robot has been injured, either burned, excess bleeding, other internal injuries and even has caused death to patients to the extent that the Federal Drug Administration has issued a recall on Da Vinci Robots for causing extensive damages to patients that the device is used on. I saw last week on television news where the FDA is going to recall and investigate the Manufacturers of the Da Vinci Robots (Intuitive Surgical Inc.) for manufacturing a defective surgical device (Da Vinci Robot) that has mechanical defects in it that do more harm than good. Ever since I had my prostate removed via the use of the Da Vinci Robot, I do not have any quality of life anymore. Also, the trauma of almost dying twice, bleeding to death several times and being a patient in the hospital for almost a month has caused me to suffer severe anxiety attacks and deep depression. After my ordeal with the Da Vinci Robot, I now have to see a psychiatrist every three months and take psych. Medications. Xanax four times a day and Effexor XR once a day. I will have to do this for the rest of my life. The Da Vinci Robot operation destroyed any quality of life that I had. In essence, since I had the Da Vinci Robotic surgery, I have had to have 6 more operations. If the Da Vinci Robot is causing more injuries and deaths than traditional surgeries then the Da Vinci Robot should be banned and never used by any surgeon ever again. Its use only destroys people lives. Thank you.
I just read Friday June 3, 2016 that the FDA has filed charges against Intuitive Surgical Supply for not submitting hundreds of malfunctions to the FDA prior to having the Da Vinci Robot approved. Also, the FDA said that Intuitive Surgical Supply Co. has placed Millions of dollars in a special account to pay patients that have been injured by their DaVinci Robot.
I personally do not feel that a Surgeon can attend a country club, pay a $1000.00 fee to watch video’s
on how to perform Da Vinci Robotic Surgery would be qualified to perform Da Vinci Robotic surgery on a human. The Surgeon must have the knowledge of what he is doing, how to do the surgery correctly and avoid injuring the patient. My Surgeon bungled my surgery and almost cost me my life. Some Federal Agency should conduct an investigation into how patients are being injured and killed by Surgeons who are not adequately trained on how to perform the Da Vinci Robotic Surgery corrctly. Also, I have read the MAUDE reports showing that a large number of patients have been injured through the use of the Da Vinci Robotic Surgery and I again feel, that is because a great many of the Surgeons are not qualified to perform the Da Vinci Robotic Surgery.
The article that I read was in Bloomberg Articles concerning the Da-Vinci Robot.
To access the article, here is the web page address:
http://www.bloomberg.com/news/articles/2016-05-26/da-vinci-surgical-robot-maker-fights-insurers-
over-hidden-claims
Please advise.
Sincerely,
Jerry F. Queen
____________________________.
Jerry Franklin Queen