Clinical Quality, the #4 priority in health care.

Clinical Quality, the #4 priority in health care.

If you refer to the front page of this website, you’ll see that I am placing Clinical Quality #4 on the list. This is referring to the quality of the care that is being delivered to you, the patient. In a series of upcoming posts, you will see why this is #4.

The Institute of Medicine (IOM) defined quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”

My definition is simpler: The right thing happens at the right time, in the right place and without defects.

Do you notice how relatively ambiguous the IOM definition is? Sort of sounds like political gobbledy-gook, doesn’t it? Yup, that’s how the medical community and industry talk about quality.

Before delving into the details, it’s helpful to know some of the history.

Before 1965, there were no organized quality programs in medicine anywhere. Nope, not even in hospitals. The quality of care was dependent on the culture of a health care entity, like The Mayo Clinic. At the same time, no one was measuring anything, so, clinical quality was mainly based on anecdotes (“ my local doctors weren’t making me better so I went to The Mayo Clinic and I’m better now”).

So, let’s go way back.

There were some historical events that improved clinical quality which were based on one really smart clinician figuring something out and aggressively championing an improvement. It wasn’t generally a group activity or promoted by “the administration” or the “medical community”. Here are two examples:

In 1850, Ignaz Semmelweis noticed that post partum women cared for by obstetricians were dying of infections. He noticed that the incidence of these infections was a lot lower in the wards attended by midwives. The difference he noted was, the doctors were tending to other ill patients and doing autopsies, and the midwives only delivered babies. The physicians would come to the labor and delivery rooms or the post-partum wards immediately after working on the ill or dead patients without washing their hands. He theorized that there was something on their hands that was spreading the infections. He didn’t know what that was. (Louis Pasteur figured that out later.) Semmelwies tested his theory by having physicians wash their hands with a chlorinated lime solution. The infection rate plummeted dramatically.

Here’s a sentence you’ll see again…His ideas were rejected by the medical community.

Florence Nightingale noticed that soldiers did worse in facilities where the conditions were poor and unsanitary. She championed making things as clean as possible, improving hygiene and improving working conditions for caregivers. The death rates plummeted. She also created and promoted standards of care for nurses. Interestingly, she was criticized.

Semmelweis and Nightingale were what some people call “heroic” leaders. They worked tirelessly to maintain the improvements they believed were critical to good patient care despite resistance from the medical community. A lot of what Nightingale proposed became ingrained in nursing. Interestingly, except for surgery and OB, Semmelweis’ hand washing went by the wayside. Doctors and nurses and other staff went from room to room without washing hands. I was never trained to wash hands in between patients unless you touched something obviously contaminated or infected. No one wore gloves unless you were doing a sterile procedure. It wasn’t until 1995 that the CDC officially proposed that clinical staff wash hands before entering and upon leaving hospital rooms and outpatient exam rooms. To this day, getting everyone to consistently wash his/her hands is an issue, despite a national call to action about it. Yes, centuries after Semmelweis figured that out, medical staff still don’t consistently wash their hands.

These notable heroic leaders pretty much promoted or dictated tasks. Wash your hands, sanitize hospital wards, etc. They didn’t really look at the process of care longitudinally. It was more insert a task or change a task. The task-oriented culture is the Achilles heel of the medical industry. We’ll get to that later.

Anyway, with heroic leaders, when they leave, things mostly fall apart unless someone equally passionate about the subject stays behind to sustain it. What is really needed is a “non-heroic” leader.

Ever heard the sentence, “Give a man a fish and he will eat for the day, teach him how to fish and he will never be hungry”? How about “some people tell time and some people are clock builders”?

A non-heroic leader teaches people to fish, and they build clocks so when they leave, people won’t go hungry and they have a way to tell time.

The first real non-heroic-type leader in medicine was Ernest Codman. He was the first to propose measuring things and setting up systems to mitigate errors. This is different than promoting tasks. Codman was a Harvard trained surgeon who was one of the founding fathers the Society of Surgeons, a precursor to the American College of Surgeons. He was practicing successfully at Massachusetts General Hospital when he came up with the idea of what he called “The End Result”. In Codman’s words, The End Result was, “The common sense notion that every hospital should follow every patient it treats, long enough to determine whether or not the treatment has been successful, and then to inquire, ‘If not, why not?’ with a view to preventing similar failures in the future”. This was the first known suggestion that the process of taking care of people should be examined and improved. Codman started keeping ledgers of all of the surgeries performed at Mass General. The other surgeons didn’t like this. The idea was met with a lot of resistance. He was actually hated by other doctors. Codman presented his End Result idea at a Surgeon’s Society meeting where he portrayed surgeons as greedy surgeons grasping for wealthy people’s money. (See, even back then, it seems, it was all about the money). The medical community at Mass General went ballistic. He was asked to resign and was ostracized. Some stories about his leaving Mass General say the other doctors burned his surgery ledgers. Codman opened his own hospital and applied his End Result idea. He wrote books about it including case reports. But, the medical community of the time never adopted his approach. He also was a champion of hospital efficiency, and actually wrote a book about that. But for a long, long time, his ideas were rejected by the medical community.

As a matter of fact, the exact opposite of what Codman championed occurred. Medicine became veiled in secrecy and no one wanted to talk about anything that didn’t go well. Unless a doctor did something so egregious that it was criminal or near criminal, doctors were pretty much left alone. Believe it or not, there is still a large component of this going on today. People only knew about medical “misadventures” when someone filed a medical malpractice lawsuit. State Medical Boards were pretty impotent, acting more like the “good old boy” system. I commonly heard, “We can’t really do something about this because this could have been me.”

It wasn’t until 1965 that some sort of organized quality program began, and only in hospitals. And it was only because of when the Medicare and Medicaid laws were passed. The laws called for certain standards to be met to ensure beneficiaries were getting appropriate care. Medicare called this Conditions of Participation. It was mostly utilization review, not quality improvement. There weren’t a lot of prescribed details. There weren’t any significant improvements. So Medicare mandated quality programs and started PSRO’s (these were committees of physicians and largely failed to make any impact) and QIO’s (these exist today). In the beginning, the hospitals, searching for something structured on which to base quality programs, chose the malpractice insurance companies’ risk triggers, like, unexpected transfer to an ICU, unexpected death, return to the ER within 2 weeks of discharge, etc. So, the hospitals essentially built their quality programs on events, and did reviews of cases that met the trigger events. This was the bulk of what quality programs did, case reviews. The result was a headhunting culture. The reviews look for who did the wrong thing or the things that resulted in the trigger event occurring. It was a culture of fear, so, clinicians and staff were always trying to hide their involvement in these events. People would be fired, embarrassed, admonished, etc.

What was really needed was an analysis of the processes of care within a culture that didn’t start with finger-pointing.

It wasn’t until about 1990 that people started to realize that 1. Human beings are error prone and 2. Processes can promote or mitigate errors.

This was due to two things, 1. A book called Human Error by James Reason and 2. The emergence of an awareness in the medical community of Statistical Process Control (SPC is based on the premise that 80% of defects and inefficiencies are due to the process, only 20% is due to individuals’ actions).

The event that seemed to spur more interest in the above was the beginning of the Patient Safety Movement, which occurred in 1998. Really, it wasn’t until 1998 that the medical community thought you ought to be kept safe from harm from medical “institutions”! As a matter of fact, before WW II hospitals were referred to “pest houses” because you were more likely to die in the hospital from something that happened in the hospital than the disease you had if you had stayed home!

Here’s a real story about this.

It was 1998. (two years before the IOM’s treatise: To Err is Human) I was the Chief Medical Officer (CMO) of a medium-size regional Managed Care Organization/Health Maintenance Organization (MCO/HMO). (I’ll use MCO from now on for these insurance companies) Once a year, just about all of the MCO’s in the country descended on Washington, DC for a large weeklong conference. There were tracks for different “positions” in MCO’s. There was a CMO track, a CEO track, a CFO track, an Employer CEO track, etc. Near the end of the week, there was a combined MCO CMO-Employer CEO 2 hour session. There had never been a track session like that before.

We were ushered into a large conference room with just about equal parts Health Plan CMO’s and Employer CEO’s. It seemed an odd combination for us CMO’s. We were wondering why it wasn’t MCO CEO and Employer CEO.

There was a long low stage set up with about 8 “panelists” sitting at a long table. The moderator said the subject of the session was Patient Safety. None of us really knew what that meant, having never heard that term before. I’m sure the Employer CEOs were thinking the same.

The moderator said the first thing they were going to do is play a video for us.

The video was about a ~11 year old boy. It was December; Christmas was approaching. The child had a “growth” on his ear that the surgeon had recommended to be removed. It was a procedure to be done under local in a same day surgery suite at the hospital. The parents were waiting in the waiting room. Suddenly the surgeon came out and told the parents that the surgery went wrong, there was a complication and the child did not survive the event. The Quality Nurse conducted an investigation and determined that the local anesthetic that was used had 10 times the amount of epinephrine than it should have, and that the anesthesiologist had given the operating surgeon the wrong bottle.

The video was stopped and four individuals gave accounts of the events including how they felt about what happened: The mother, the surgeon, the anesthesiologist and the Quality Nurse. It was extremely emotional, the mother obviously still grieving, the surgeon and anesthesiologist guilt ridden, the Quality Nurse compassionate.

The bottom line reached by the panelists was, the process, or lack of it, was the cause of this boy’s death. The participants in the process were well-trained and doing what they thought was right. The moderator went through statistics from studies from 1990-1995 about harms and deaths from “medical adverse events”. The moderator then opened the dialogue to those of us in the audience. Of course, we were all stunned.

The first utterance was from an Employer CEO. His exact words were, “What are you health plan CMO’s doing all day long that you are allowing something like this to happen?”

Well, we thought, they actually had the wrong CMO’s in the room. They should have had the Health Care Delivery Systems’ CMO’s. How would we know what was going on day to day in hospitals? The Employer CEO’s said we should be holding the Health Care Delivery Systems accountable, sort of like the Patient Safety Police.

The start of the Patient Safety Movement was really a watershed event in medical quality. Although there were some (vast minority) health care systems that had started to adopt and train their staff in SPC (using The Improvement Model or FOCUS-PDCA), there was little evidence that anyone could do it well except for one or two institutions, like Intermountain Healthcare in Salt Lake City.

I recall being at a management meeting of a health care system that had hospitals, a medical group and a health plan in 1999 where I presented this emerging Patient Safety Movement. I was sitting next to the Chief Operating Officer of the hospitals. After some inquiry dialogue by the group, the COO said (exact words), “Well, we don’t have to do anything about this right away since this stuff has been going on for years.” Really? Seriously? See why your quality care is #4?

Sidebar: I actually took a year of the agendas for the highest management team meetings in an integrated health care system. 95% of the time spent by the most senior management team had nothing to do with patient care. It was mostly budgets, growth, HR issues, IT, marketing, etc. When I showed this to them the CEO said, “Well, we have Quality Committees that deal with that, we don’t need to go over that here.” Really? Want to know why Clinical Quality is #4?

Here’s another true story. Remember, I was the CMO of a health plan. I really took this Patient Safety Movement to heart, since, as a physician, this sentence was pounded into our brains, “First, do no harm.” It’s part of the Hippocratic Oath we all took. I started looking at whether a health plan and its processes could create a patient safety event. A case occurred that required a “root cause analysis” that confirmed my suspicion. Here’s a synopsis of that event.

A Medicaid member of our Medicaid Health Plan was admitted to a hospital with a ruptured appendix. She was a minor. She had the surgery and post-op was put on two antibiotics since ruptured appendices can cause an abdominal infection. The patient was discharged on the two antibiotics. One of them was not on the health plan formulary, so it required a “prior-authorization”. Error #1 – The hospital surgeon didn’t know which antibiotics were on the formulary (health plan based error).

The patient was discharged at 3:00 PM on a Friday. Her mother went to the drug store and handed in the prescriptions from the hospital. The Pharmacist told the mother that one of the antibiotics was not on the formulary and her primary care physician (PCP) would have to get an authorization from the health plan or the patient would have to pay out of pocket for the antibiotic, which cost more than $100. Since Medicaid folks can rarely afford $100 for a medicine, the mother left without the antibiotic, requesting the pharmacist notify the PCP. Error #2 – The Pharmacist didn’t access the health plan’s telephonic expedited authorization process. (health plan based and pharmacy based error). Error #3 – The Health Plan didn’t have an emergency Pharmacist driven prior-authorization override policy (health plan based error). The Pharmacist used the routine process to get the authorization…he faxed a request to the PCP office, assuming the PCP would send the authorization form to the health plan, who would then put an edit in the computer system to allow payment for the antibiotic. (Notice, none of the clinical folks talked to each other. This was a totally fax based communication system)

Well, it was about 4:00 before the fax was sent. Now, if you’ve ever been in a “modern” PCP office on Friday afternoon, you’d know that the PCP and staff were focused on getting out on time, which, nowadays is as close to 4:00 as possible. No one in the office checked the Fax stack that day. Error #4 – Inattention of the Office Staff to incoming notices. (PCP office based error) In fact, the office staff didn’t find the fax until Tuesday morning. The PCP sent the authorization request to the health plan at 2:00 PM that day. Error #5 – Delay in processing the authorization at the PCP office. (PCP office based error)

The big problem was, the Medicaid member had been re-admitted to the hospital with an abdominal infection at 9:00 AM Tuesday morning, five hours before the authorization request was sent to the health plan.

The root cause found by the quality staff was: the need for a prior –authorization for a critical medication for a patient being discharged from the hospital. We changed our policy to: anyone with a prescription coming from a hospital (inpatient, ER or Urgent Care) would have that prescription filled regardless of whether it needed a prior-authorization or not. Meanwhile we worked on figuring out how to make sure discharging physicians would be able to know whether a drug was on the formulary or not. Believe it or not, to this day, even with an Electronic Medical Record and a national system like Surescripts, knowing what is on a health plan’s formulary is very problematic.

Here’s the kicker. I wrote up a proposal to start up a health plan based Patient Safety Committee that not only looked at patient safety cases from the delivery systems, but that also looked at and tried to mitigate health plan patient safety events. That had to go to the Board of Directors. They couldn’t understand how a health plan could cause patient safety events. I had to go back to the Board meeting two more times with case reviews like the above to convince them that we should have a Patient Safety Committee and that a health plan could cause patient safety events. As I went to conferences after this and talked about our Patient Safety Committee and that we were looking at cases where the health plan policies and actions caused adverse patient safety events, none of the other health plans would agree to or admit that a health plan could cause patient safety events. To them it was a delivery system problem, and the role of the health plan was to hold them accountable. My ideas were rejected by the medical community. To this day I don’t know of any other health plan that looks at or thinks they have an active hand in causing patient safety events and I’m pretty sure the health plan in the above story has abandoned their committee (I left there 8 years ago).

Anyway, if you noticed, it always takes an outside force to get the medical community to do something. First, Medicare, and then, the Patient Safety Movement in this story. Employers got in the act and created Leapfrog, which rates hospitals on safety, but, it’s voluntary and not all hospitals participate. Leapfrog gives non-participating hospitals a failing grade.

So, you’re getting some idea why Quality is #4. More to come.