Disclosure and Apology Must Be Taught Before They Can Be Learned

Over two years ago, the folks over at the athenahealth kindly invited me to submit columns to their Health Leadership Forum, and I have done so on an occasional basis since them. As I recently reviewed the columns, I realized that my own thoughts on the topics of leadership and coaching have evolved a bit, and I thought my readers over here at Not Running A Hospital might enjoy witnessing the transition. So for several days, I will be reprinting the posts from the Forum over here. Comments are welcome at the original site and here. Today's reprint is from a post dated July 23, 2013, "Disclosure and Apology Must be taught Before they Can be Learned."

If our objective as leaders is to gradually transform the health care system to make it more patient-centered, we need to ensure the rising classes of young doctors are trained to carry out this form of medicine. Unfortunately, as noted by the Lucien Leape Institute, “[M]edical schools and teaching hospitals have not trained physicians to follow safe practices, analyze bad outcomes, and work collaboratively in teams to redesign care processes to make them safer.”

As Dennis S. O’Leary, MD, President Emeritus of The Joint Commission and a member of the Institute has said, “Educational strategies need to be redesigned to emphasize development of the skills, attitudes, and behaviors that are foundational to the provision of safe care.”

Among the most important skills to be taught to doctors is how to disclose medical errors to patients and families. Yet, training in this topic is often relegated to a single lecture sometime during medical school. Is there any question why the material doesn’t “take” when it is treated so casually?

The great basketball coach John Wooden liked to say, “You haven’t taught until they have learned.” How best to design a curriculum that truly enables young doctors to learn the fundamentals of disclosure?

David Mayer, MedStar Health’s VP for Quality and Safety, is one of the country’s leaders in undergraduate and graduate medical education. He explains, “Disclosure training is a process, not a fifty-minute lecture.” He and colleague Tim MacDonald developed the first four-year, longitudinal patient safety curriculum for medical students in the country. That curriculum started on the very first day of school at 8:30 a.m. He notes:

During the first half of the hour-long session, I always asked the students to share with me the fears they had on this first day of school, the starting point on their journey to becoming a physician. Each year I did this, two fears rose to the top – the fear of failure and the fear of hurting a patient. Students read the newspapers that share personal stories of harm or talk about the medical error crisis; many students had a family member harmed from a medical mistake. As an educator, it was a great teaching moment to start the safety conversation, and the reason why we started the conversation on the very first day of school.

Over the years, the students were taught the “Seven Pillars” disclosure and apology model developed by David and Tim for the University of Illinois Hospital in Chicago. This model comprises a rapid response to all unanticipated outcomes, full disclosure related to the care, apology and early compensation, if warranted, and using transparency and disclosure to learn from all our mistakes so that we implement the necessary changes to our system to reduce risk to others. (The Seven Pillars approach was cited by Agency for Healthcare Research and Quality [AHRQ] director Dr. Carolyn Clancy and led AHRQ to fund a three-year project to spread the model in 10 Chicago-area hospitals.)

For the last two years, I’ve had the pleasure and privilege of joining David, Tim, and other colleagues in Telluride, Colorado to conduct week-long training programs for residents and medical students on this and other aspects of disclosure and apology. What emerges is often a cathartic experience for these trainees. Many have borne witness to medical errors being committed in front of them, often by senior residents or attending physicians. They bear the guilt of being afraid to say anything that might arouse the wrath of their instructors. When provided a safe environment with their peers and empathetic instructors, they often tearfully relate their experiences.

Together, we design strategies that they can personally employ when they return to their hospitals. But we also require them, as a condition of attending our seminar, to design and carry out a safety-related transformational project in their hospital.

The results from even this one-week session are impressive. Pharmacy resident Quyen Nguyen stated: “One of the most important lessons I have learned from the past three days is the urgency in which we need to act to bring ethics back to the forefront of healthcare systems. Too often the best interests of the patients and their families are put behind financial, legal, and personal factors. It may never be possible to prevent every error, but we have a professional duty to take responsibility and put patients’ and their families’ needs first in the aftermath of a medical error.”

Resident Pat Bigaouette said, “The most important thing that I learned while in Telluride was the importance of passion. I sat and listened as passionate after passionate lecturer shared their experience and expertise with me. I learned how they have all made a difference in their respective healthcare systems by being enthusiastic and passionate. I found myself going home and discussing patient safety for hours after the conference had ended.”

Suresh Mohan returned to his residency program in Rhode Island and noted: “Discussing my week with peers back home, I was shocked to realize how little they knew (and, thus, cared) about the topic of safety. I received responses of, ‘Well, I guess every field has its downsides’ to ‘Whoa, I didn’t know you were, like, super into that primary care stuff.’ It reaffirmed my decision to have attended, and the value of what we learned.”

And Garrett Coyan left us all with an agenda: “The last week I spent at Telluride was very eye-opening for me. Reinvigorated with ideas for improving communication and decreasing risk to my patients, I couldn’t wait to get back to my institution and start implementing change. However, as I returned to the hospital today, I was quickly reminded of the main reason why this goal will be so difficult. Not only does cultural change need to occur in the hospital, but I would argue that even more importantly, cultural change needs to occur in the education of students in the health professions.”

There are steps in the education of young doctors that are our obligation if we are associated with health care institutions. As David Mayer notes: “The day has now come for greater accountability in medical education around safety and quality.” In a series of blog posts, he has set out the elements of an education program characterized by rigor, thoughtfulness, and pedagogical excellence. If you are in a position to influence the education program in your hospital, please read David’s three posts by clicking the following: part one; part two; part three. Then, use your leadership position to move your institution forward in designing and implementing this kind of educational program for your medical students and residents.

There is a potential bonus in all of this for hospital administrators. It is well-documented that the incidence and size of medical malpractice claims are reduced when physicians show empathy and apologize after errors are made; when they accurately portray the nature of what occurred; and, when they demonstrate that the hospital will learn from the experience so that future patients might be spared the same type of harm. Many older doctors are not adept at carrying out such a disclosure and apology. Raising a new generation of doctors who are skilled at this might therefore produce ancillary benefits for hospitals.

When Good Teams Go Wrong

Over two years ago, the folks over at the athenahealth kindly invited me to submit columns to their Health Leadership Forum, and I have done so on an occasional basis since them. As I recently reviewed the columns, I realized that my own thoughts on the topics of leadership and coaching have evolved a bit, and I thought my readers over here at Not Running A Hospital might enjoy witnessing the transition. So for several days, I will be reprinting the posts from the Forum over here. Comments are welcome at the original site and here. Today's reprint is from a post dated May 28, 2013, "When Good Teams Go Wrong."

When things go wrong in a hospital—on either the clinical or administrative front—we are often left wondering how a dedicated and thoughtful team of people could have jointly participated in the decisions and actions that led to the failures. Recent stories in the news may give us a clue.

Problems recently uncovered at the Internal Revenue Service are typical of those found in many organizations when a team of people become isolated and feel unsupported. The team might be doing a job that nobody else wants to do or is out of the mainstream, work often characterized by a large number of repetitive tasks. Things appear to go well for a while but then take a turn for the worse.

In a Harvard Business Review article I authored in March 2001, I named this syndrome “The Nut Island Effect.” I told the story of a team of skilled and dedicated employees working at the Nut Island sewage treatment plant who became isolated from distracted top managers, resulting in a catastrophic loss of ability to perform an important mission, preventing the pollution of Boston Harbor. The irony was that from the outside, the team had all the attributes of an ideal working group: dedication, collaboration, a strong sense of integrity and values, and indefatigable energy with regard to doing the job.

The employees at Nut Island had set up their own team without the direction and guidance of management, and it had become a priority among the group to avoid contact with upper management whenever possible. Indeed, they viewed senior management as a common adversary.

This isolation led to a lack of accountability with regard to the strategic objectives of the agency. It also precluded an infusion of new ideas and approaches, so that the group began to make up its own rules. The rules, though, were insidious because they fostered within the team the mistaken belief that its operations were running smoothly. Yet, the rules actually resulted in improper operation of the plant and increased pollution of the harbor.

In the years since publishing “The Nut Island Effect,” I have often heard from doctors, nurses, and hospital administrators who have said, “I felt like you were writing about my place! You could have written this story about my operating room (or ICU, or administrative division.)”

Look at these excerpts from a recent New York Times story, “Confusion and Staff Troubles Rife at Cincinnati IRS Office.” Then think of your own hospital and see if you might apply some or all of those descriptors to a functional area in your organization:

Low-level employees, in what many in the I.R.S. consider a backwater, processed thousands of applications a year. Inside the agency, the unit was considered particularly unglamorous. Interviews paint a more muddled picture of an understaffed Cincinnati outpost that was alienated from the broader I.R.S. culture and given little direction. There were times where staff came up with shortcuts that were efficient but didn’t take into consideration the public perception.

In the world of Washington politics, there is a tendency to blame the front-line staff in this kind of situation. Unfortunately, the same tendency often exists in the health care world. But within the IRS, as in your organization, the responsibility has to be shared with the top management.

The Nut Island story prompted me to generalize a five-step process that defines the progression from management-employee alienation to employee self-regulation of critical processes to, finally, mission failure:

1) Senior leadership, focused on high-visibility problems elsewhere in the organization, assigns an important, but behind-the-scenes, task to a team and gives that team a great deal of autonomy. The team members become adept at organizing and managing themselves, and the unit develops a proud and distinct identity.

2) Senior leadership takes the team’s self-sufficiency for granted. Ironically, the unit may often be viewed as an exemplar of “team spirit.” At the same time, team members are ignored when they ask for help or try to warn of impending trouble. The team feels betrayed by management and becomes resentful.

3) As a result, an us-against-the-world mentality takes hold within the team, along with a heightened sense of being a band of heroic outcasts. Now, the team grows skillful at disguising its problems, driven by a desire to stay off the radar screen of the senior leadership. Team members never acknowledge problems to outsiders or ask them for help.

4) Senior leadership, for its part, is more than happy to assume the team’s silence means that all is well. The team begins to make up its own rules and tell itself that the rules enable it to fulfill its mission. In fact, though, these rules mask grave deficiencies in the team’s performance.

5) Both sides, senior leadership and the team, form distorted pictures of reality that are very difficult to correct. They shun one another until some external event, often a catastrophe, breaks the stalemate.

It is far better to avoid the circumstances that lead to The Nut Island Effect than to try fixing the syndrome after it has developed. Traditional management theory suggests the way to avoid the problem is to impose key performance indicators (KPIs) on the department, division, or group. KPIs are supposed to be reflective of the broader strategic priorities of the organization, but there are thousands of examples where the existence of KPIs has been ineffective in solving the underlying sociological problem of a good team that has gone wrong.

The ultimate way to avoid The Nut Island Effect is to foreclose the possibility of isolation in the first place. The most effective way to do this is create a culture of process improvement in which it is the management’s job to be physically present and responsive when people working on the front-line call out problems and obstacles in their day-to-day work. Management has to assume the role of “servant leaders,” in which they work for the staff and not vice-versa. This approach to the design of work is inherent in the “lean management” philosophy but can exist in any organization. Where it does not, it is a symptom of leadership failure that will some day lead to catastrophic results.

Learning from Mistakes

Over two years ago, the folks over at the athenahealth kindly invited me to submit columns to their Health Leadership Forum, and I have done so on an occasional basis since them. As I recently reviewed the columns, I realized that my own thoughts on the topics of leadership and coaching have evolved a bit, and I thought my readers over here at Not Running A Hospital might enjoy witnessing the transition. So for several days, I will be reprinting the posts from the Forum over here. Comments are welcome at the original site and here. Today's reprint is from a post dated May 3, 2013, "Learning from Mistakes."

As a leader, you must do everything you can to encourage people to admit mistakes they have made and to call out problems they have found in the organization. (As Amy Edmondson of Harvard Business School similarly suggested in an earlier post). If people think they will get in trouble for having erred, or for having brought up a systemic problem in the organization, those errors and problems will go unreported. The person and the organization will thereby lose an opportunity to grow and improve. Accordingly, a strong commitment not only to transparency but to a just culture is essential to achieve continuous improvement.

Leadership’s role in such matters is determinative of process improvement in the organization. Equally important, it also empowers the personal and professional growth of people in the firm.

MIT Management Professor Edgar H. Schein has described the communications ethic inherent in such an environment as follows: “Team members have to learn how to analyze and critique their own and each other’s task performance without threatening each other’s face or humiliating each other. That means that subordinates have to learn how to tell potentially negative things to their superiors, and superiors have to learn how to not punish their subordinates for telling the truth if that truth is inconvenient. That, in turn, requires the ability to give and receive feedback in a constructive manner.” (Helping, How to Offer, Give, and Receive Help, Barrett-Kohler Publishers, Inc. San Francisco. 2009. Page 118.)

But true process improvement also requires leaders to go one step further, to take ownership of flaws in their organization. Paul Wiles, former President and CEO of Novant Health in Winston-Salem, NC, once told me and a group of hospital CEOs a heart-wrenching story about an infant’s death from sepsis in his hospital, which was tracked to an MRSA (antibiotic-resistant staph) infection. The infection was part of a spread of a bug in his neonatal intensive care unit (NICU) that reached 18 infants in all and may have contributed to the deaths of two others.

“This was a direct result of staff not washing their hands appropriately,” he said. Since that event, “We have been on a relentless hand hygiene campaign.”

The crux of his entire presentation was this comment: “My objective today is to confess. ‘I am accountable for those unnecessary deaths in the NICU. It is my responsibility to establish a culture of safety. I had inadvertently relinquished those duties,’ ” he noted, by focusing instead on the traditional set of executive duties (financial, planning, and such). Wiles ended his talk to the CEOs in the audience, saying, “If you cannot see the face of your own relative in a patient, or if you cannot see the face of your own son or daughter in the face of a distraught nurse or doctor who has made an error, I suggest that your executive talents would be better placed in other industries.”

But it is not just leaders in the hospital world who have come to these conclusions. Let’s head to an oil rig in the North Sea.

A number of years ago, Tom Botts was involved in a tragedy aboard an oil rig in which he personally had to call off the search for men missing at sea. Deeply shaken, when he later moved on to be Executive Vice President for Shell Oil Company’s exploration and production activities in Europe, he decided that he would implement the most comprehensive program possible to protect workers’ safety at these remote outposts in the ocean. Notwithstanding that new program—the best in the industry—two men lost their lives on a North Sea oil rig when they mistakenly went into a portion of the facility that should have been off-limits. It would have been easy to blame the two men who, after all, entered a prohibited area. Instead, Tom launched a thorough, top-to-bottom review of the organization.

He explained, “We decided to be as open and transparent about the incident as possible and went through a ‘Deep Learning’ journey involving hundreds of people that examined in detail all the root causes that contributed to the accident to get a clear picture of the system that produced the fatalities. Even though the two men who were killed could have made better decisions, my senior leadership team and I could find places where we ‘owned’ the system that led to the tragedy.”

“It was a defining moment for us when we, as senior leaders, were finally able to identify our own decisions and our own part in the system (however well intended) that contributed to the fatalities. That gave license to others deeper in the organization to go through the same reflection and find their own part in the system, even though they weren’t directly involved in the incident.”

Tom continued, “Once you take that step of committing to transparency and learning, it sets a high bar and it is very hard (probably impossible) to take it back. This approach has helped make us stronger and more aware of the impact of our daily decisions.”

Turning back to health care, Dr. Charles Denham wrote an article in which he related the practice of nursing chief Jeannette Ives-Erickson, Senior Vice President For Patient Care and Chief Nurse at Massachusetts General Hospital. When a nurse makes an error in caring for a patient, Jeanette calls the involved nurse into her office and asks one question: “Did you do this on purpose?” When the nurse answers, “No,” then Jeannette says, “Well then it is my fault… errors stem from system flaws … I am responsible for creating safe systems.”

Chuck notes, “In a few short moments with a caregiver after an accident, the leader declares ownership of the systems envelope, and the performance envelope of her caregivers, and creates a healing constructive opportunity to prevent a repeat occurrence.” (“May I have the envelope please.” Journal of Patient Safety. 2008 Jun;4(2):119–123.)

Chuck properly warns us that it is easy to “automatically fall in a name-blame-shame cycle, citing violated policies, and ignore the laws of human performance and our responsibility as leaders.” It is up to us as leaders to be mindful of the results of such behavior on our part. The bad example we set cascades through the organizations. Mistakes and near-misses go underground, as people fear that reporting will just get them into trouble. Opportunities to improve our systems are lost, along with the potential for personal and professional growth on the part of our staff.

In contrast, behaving like Wiles, Botts, or Ives-Erickson empowers those working with us. People evolve individually and collectively into a learning organization. Each person feels that he or she is valued, understands his or her place in the firm, and goes home able to say, “I accomplished something worthwhile today.”

Gene cites John: Makes great sense!

For some of us, one thing that makes Friday a great day is receiving Gene Lindsey's weekly email.  It's full of observations about the health care world, living in the woods of New Hampshire, and baseball--not to mention nostalgic visits to his childhood. (You can read previous editions here.)

Gene is a die-hard adherent of Lean, a process improvement and managerial philosophy that has both been used to great effect in the hospital world and has been an utter failure in the hospital world.  I am pleased that my hospital's experience fell into the former camp. In this week's edition, Gene reviews John Toussaint's latest book Management on the Mend, where he excerpts useful thoughts offered by one of the most successful employers of Lean.

Why has Lean succeeded in some places and failed in others? Gene summarizes the key lesson from the book:

"I think there is great evidence that John has walked the talk. Indeed the necessity that leaders be personally transformed if organizational transformation is to occur is a recurrent theme in the book which is really an open letter to healthcare leadership and their boards with the express purpose of convincing them that leadership is critical to Lean success. He introduces this idea on page three!

"The most common problem that I see [discussing the more than 145 organizations that he has personally visited that are in various stages of understanding Lean] is that leaders fail to recognize the magnitude of change that will be required and that change extends to leaders on a personal level."

I wrote back to Gene:

I went through it by osmosis, I guess, but as I look back on it later, I see a major maturation that took place in my leadership approach. 

Indeed, it was not until after I left my CEO post at BIDMC that I realized the extent of my own transformation and that I had adopted the mantra, "Lead as though you have no authority." Mark Graban interprets this:  "This doesn’t mean completely giving away your authority… it means not relying on that formal authority."  Or as W. Edwards Deming put it: "The leader is coach and counsel, not a judge."

As I meet with hospital clinical and administration leaders, I can quickly see which ones have reached this level of comfort in learning that their job is to work for the staff--not vice versa. And I can draw a quick correlation between their progress in doing so and the degree to which their institutions have become learning organizations.

If you are in a leadership position in a health care system, read John's book.  Then, lead or not.

Whole systems approach to product design at MIT SDM

A Whole Systems Approach to Product Design and Development

 

2015 MIT SDM Conference on Systems Thinking for Contemporary Challenges

October 7, 2015 at Wong Auditorium, MIT

Neal Yanofsky, Chairman, Cheddar's Scratch Kitchen; Board Member and Senior Advisor, Snap Kitchen                                               

Keynote — Can Managers Contribute to Design that Creates Competitive Advantage?

Everyone loves outstanding design, but how can it be used as a business tool that provides more than fleeting benefits? And how can left-brained managers effectively support and develop the work of right-brained designers?

In this keynote address, Neal Yanofsky will explore the benefits and challenges of elevating design to a strategic tool.

Additional speakers include: Todd P. Coleman, PhD; Steven D. Eppinger, ScD; Pat Hale; Matt Harper; Matthew S. Kressy; Shaun Modi; Joan S. Rubin; and Maria C. Yang, PhD.

We invite you to join us! Register today.

About the Conference

The annual MIT Conference on Systems Thinking for Contemporary Challenges, sponsored by the System Design & Management program, provides practical information from multiple disciplines for using systems thinking to address complex challenges, whether in industry, academia, government, or the world at large. All are welcome to attend.

SEIU goes to the ballot to change hospital rates

Somewhat new to the issue, the SEIU has decided that it is unfair for non-Partners hospitals to get paid less than those affiliated with Partners Healthcare System. Priyanka Dayal McKluskey reports in the Boston Globe that the union "is pushing a ballot initiative that would divert millions of dollars from Partners HealthCare to lower-paid competitors in an effort to boost community hospitals and preserve union jobs."

My readers know that I am sympathetic to the cause of equalizing insurance payments to the hospitals and physicians in the state.  Now, they are set mainly on the basis of market power, something contrary to the public good. Some of us have been talking about this issue for over a decade.

But why is the union more recently interested in the topic?

My hypothesis is that they finally realized that the stated business strategy of Steward Health Care System to be the low-cost provider competing with Partners just doesn't hold water.  Steward has shown no ability to attract patients from the bigger system. The only thing that "lower costs"--read "lower rates"--has gotten the system is lower revenues and poorer earnings.

Years ago, the Steward CEO got the support of the SEIU when the Caritas Christi system was to be sold to Cerberus. Remember this story?

To steer the deal through, he orchestrated an unlikely alliance of the Boston Archdiocese, Democratic elected officials, the Service Employees International Union (SEIU), and community organizers in some of the state’s poorest cities – all to support turning the struggling nonprofit hospital chain into a for-profit operation owned by a group of high-flying financiers. In what may well be an example of the way de la Torre is always playing chess four moves ahead, the crucial SEIU support was an outgrowth of a nearly unprecedented overture he had made two years earlier, shortly after he joined Caritas, to invite the union to come into the hospitals and try to organize his workers.

Well, the deal starts to look vacuous if the hospital system can't earn enough money to cover those union contracts.

Can it be that the SEIU is actually a stalking horse for Steward on this proposed legislation?

The campaign seems to have started in earnest in 2013. Robert Weisman at the Globe reported on May 13, 2013: 

An unusual alliance led by the state’s fastest-growing health care company and its largest health care union will press for higher payments to community and safety net hospitals, saying Massachusetts faces a widening gulf between the quality of care in affluent and low-income areas.

The group, the Massachusetts Healthcare Equality and Affordability League, is being launched Thursday by Steward Health Care System, a for-profit cluster of community hospitals, and Local 1199 of the Service Employees International Union, which represents about 47,000 workers in the state.

The follow-up was reported on March 14, 2014, by Rachel Zimmerman on Commonhealth: 

A report released today by the Healthcare Equality and Affordability League (H.E.A.L.) — a partnership between the for-profit Steward Health Care System and the union, 1199 SEIU United Healthcare Workers East — finds that disparities in hospital costs and financing across the state are driving “a vicious cycle” of inequality in health care.

It's hard to be sympathetic to the financial concerns of a union that spent millions of dollars on a corporate campaign to disparage my former hospital.  (More on that story here.)

It's also hard to find sympathy for a union that, even in 2014, supported the gubernatorial candidacy of the former Attorney General who affirmatively acted to enhance Partner's market power.

And it's hard to be sympathetic to a hospital system owned by a private equity firm.

But the issue raised in the ballot proposition is a real one, and one that was aggravated--not reduced--by state legislation in 2012.

Referenda, as noted by the state hospital association's executive vice president in McCluskey's story, are not the best way to resolve complicated policy issues.  Instead, it's time for the legislature to revisit the matter.

When you have a hammer

Christopher Weyant in The New Yorker, June 8-15, 2015

It's well past time to talk about the elephant in the room when it comes to robotic surgery: The increased anaesthesia-related risks from these procedures.  The question I ask today is whether, as part of the informed consent process, patients are given information about such risks.  Under principles of shared decision-making between the doctor and the patient, such risks should be carefully explained well before the short stay at the pre-op area.

I've found little in the recent literature about this topic, although--based on my small sample of anaesthesiologists--it is a significant concern among their profession.  The concern most often expressed has to do with the extended length of procedures conducted robotically compared to traditional laparoscopic procedures or open procedures.  While anaesthesiologists are very good at handling long cases--and even unexpectedly long cases--they will generally tell you that, everything else being equal, the less time spent under anaesthesia the better.

The articles I have found about anaesthesia risk interestingly do not cover the extended time in the operating room.  This study from Henry Ford back in 2007, for example, focused on difficult airways and the like.

The length of robotic procedures results from two factors--the time it takes to accomplish pre-surgical "docking" of the machine and the time actually spent to conduct the procedure.  In the living donor liver resection case I discussed in a previous blog post, I noted:

Of particular note, the authors acknowledge that "the length of surgery was longer than that normally required for open right donor hepatectomy," but then state that "it must be considered that the complicated venous anatomy prolonged the total operating time." I can't evaluate the latter clause, but my understanding from experts in the field is that the 8-hour duration of this case was considerably longer than a standard open donor hepatectomy, which is usually 5 to 6 hours.

A colleague noted in a recent recent case that five hours had been budgeted in the operating room for a robotically assisted hysterectomy and uterine fibroid removal, well longer than would have been required for a manual approach.  Fully two hours of that time was budgeted for docking of the robot to align it and its instruments with the patient's body.

In another case, an esophogeal cancer resection in the early days of robotic surgery, the patient was under anaesthesia for 12 hours because of complications due to the use of robotic technique.

There seems to be a reluctance in the surgical profession to even acknowledge these more lengthy procedures.  Note the liver case above, where the surgeon's article--without support--ascribed the length to "complicated venous anatomy."  In the esophogeal cancer case, when the case was brought to departmental M&M's for review, no one in the room dared speak up about the wisdom of proceeding with robotic assistance because the surgeon in question was a favorite of the chief of the department and because the institution in question had invested heavily in being a national leader in robotic surgery.

Beyond the time concerns, there are other anaesthesia risks. One example comes from an early case involving a thyroid removal. As part of the consent process, a highly experienced anaesthesia attending informed the patient that in traditional thyroidectomies, he would normally be sitting at the head of the table during such a procedure. He noted that the instruments being used in a robotic thyroid removal had the increased potential to cause a unilateral or bilateral pneumothorax. Use of the robot would require him to be six feet away, making it challenging to detect such a complication as quickly, and he might thus respond more slowly to it.

This article mentions this kind of risk as well as others:

The endotracheal tube should be taped securely, appreciating that patient positioning may alter tube placement over time (unintended extubation or mainstem intubation), robotic instrumentation may dislodge a tube, and an obstructed view may delay recognition of a tube that has become dislodged. Replacing an endotracheal tube would be challenging for robotic surgery patients based on positioning and the time delay associated with undocking.
 
Others appear to be less concerned. A similar type of risk was noted in this 2009 article. but then it was quickly dismissed:

Finally, the bulk of the robot is positioned over the abdomen and chest. Although the incidence of airway or serious cardiovascular events are no greater in robot-assisted surgery, if they do occur, the position of the robot will interfere with effective cardiopulmonary resuscitation and airway interventions. The theatre team should practise and be familiar with an emergency drill for the removal of the robotic cart. With practise, at our institution, this drill has enabled us to be able to consistently remove the robot within 30 s. It is possible to deliver a DC shock with the robot docked in position if required.

In the thyroid surgery case, the patient inquired about the matter to the surgeon, who was very upset that the anaesthesiologist would convey these additional risks to "his patient." The anaesthesiologist was never asked to attend on another robotic procedure with that surgeon.

My concern today is not risk per se, as all surgery involves a balancing of benefits and risks. The question I ask is whether hospitals have properly incorporated the full spectrum of risks into their informed consent and shared decision-making processes. I also have a concern that anaesthesiologists, because of professional risk and institutional commercial priorities, will not feel empowered to point out such risks to patients under their care.

The medical arms race made visible

With thanks to Priyanka Dayal McCluskey at the Boston Globe, we can get a glimpse of one "small" part of the medical arms race in action.  The story is about the expansion of Mevion Medical Systems Inc., a manufacturer of proton beam machines.  The company offers the "more affordable price tag of about $25 million" per machine, compared to the first generation $250 million models.

Here's the arms race quote:

Three Mevion systems are treating patients at hospitals in St. Louis, Jacksonville, Fla., and New Brunswick, N.J. Four others are being installed. The company is developing about 20 other orders. 

Here's the relevant context:

“In a perfect world, if the capital costs were the same, proton therapy is something you’d want all patients to receive,” [MGH's Jay] Loeffler said, “but because of the capital costs, it has to be limited in use to only the situations we believe it’s best for.” This includes tumors in children and tumors in adults that are in or near critical body parts like the brain or eyes.

Some hospitals use proton therapy to treat prostate cancer — even when there is no scientific evidence it’s a more effective treatment than traditional radiation, said Dr. Durado Brooks, director of cancer control intervention for the American Cancer Society.

“Because it’s newer doesn’t necessarily mean it’s better’’ for prostate cancer, he said. “At this point we just don’t know.” 

Here's an endorsement about the science behind the machine presented on the company's website:

What is American Shared Hospital Services?

American Shared Hospital Services is a publicly traded healthcare company (New York Stock Exchange AMEX symbol AMS) with a 25-year track record of leasing state-of-the-art medical equipment to hospitals and medical centers in the United States.

Through GK Financing, LLC (GKF), our majority owned subsidiary, we are the leader in Gamma Knife unit ownership with approximately a 16% market share in the United States. Our Gamma Knife model has been expanded to incorporate the financing of other technology solutions including Intensity Modulated Radiation Therapy (IMRT), Image-Guided Radiation Therapy (IGRT) and Proton Beam Radiation Therapy (PBRT).

In the corporate history, we note these items:

2006: We enter the proton beam radiation therapy (PBRT) market by acquiring an equity interest in Still River Systems, Inc., developer of the Monarch 250, a practical, cost-efficient, single room PBRT system. In turn, we are able to contract with Tufts Medical Center in Boston, MA. for a complete radiation therapy department upgrade that includes an IMRT/IGRT as well as a single-room PBRT system. 

We contract with Orlando Regional Healthcare M.D. Anderson Cancer Center in Orlando, FL on our second single-room PBRT facility. 

2007: We increase our equity interest in Still River Systems, Inc.

2008: We agree to provide Todd Cancer Institute at Long Beach Memorial Hospital, in Long Beach, CA with a single-room PBRT facility – our third to date. 

2009: We sign a letter of intent with the Todd Cancer Institute at Long Beach Memorial Hospital, in Long Beach, CA for a single-room PBRT facility – our third to date. 

I know you'll join me in being glad that ASHS has no vested interest in this product and is highly qualified to present a scientific opinion!

Let's recap. "We just don't know" if it's better, but Mevlon has sold or will sell 27 installations at $25 million, or $675 million.  Oh, aided and abetted by a Medicare pricing regime that provides higher rates for use of the machine.  The company notes:

Treatment sites where proton therapy is used:

Pediatric Tumors
Head and Neck
Brain
Eye
Prostate
Lung
Breast
Gastrointestinal
Gynecologic
Genitourinary
Sarcoma
Lymphoma 

The board has to be on board

Those of us who have run hospitals where we've been serious about achieving improvements in quality and safety know that without a highly committed board of trustees, the results will never be sustainable. And so it is lovely to see documention of that premise in a new article by Thomas C. Tsai, Ashish K. Jha, Atul A. Gawande, Robert S. Huckman, Nicholas Bloom, and Raffaella Sadun in Health Affairs. I reprint the abstract:

National policies to improve health care quality have largely focused on clinical provider outcomes and, more recently, payment reform. Yet the association between hospital leadership and quality, although crucial to driving quality improvement, has not been explored in depth. We collected data from surveys of nationally representative groups of hospitals in the United States and England to examine the relationships among hospital boards, management practices of front-line managers, and the quality of care delivered.

First, we found that hospitals with more effective management practices provided higher-quality care. Second, higher-rated hospital boards had superior performance by hospital management staff. Finally, we identified two signatures of high-performing hospital boards and management practice. Hospitals with boards that paid greater attention to clinical quality had management that better monitored quality performance.

Similarly, we found that hospitals with boards that used clinical quality metrics more effectively had higher performance by hospital management staff on target setting and operations. These findings help increase understanding of the dynamics among boards, front-line management, and quality of care and could provide new targets for improving care delivery.

Where would you rather serve?

Which is more hierarchical, the military or health care?

A medical student who had served as a corpsman in the military attended our Telluride Patient Safety session last week.  She noted her experience while on clinical rotations:

I thought that when I got into medical school that I would be in a safe place to learn. . . and it wasn't. 

I couldn't believe that I was now in a system where I couldn't speak up.

As a medical student, I feel like my concerns are disregarded. Coming from the military, where every concern is heard, it's critical.

On checklists

This article by Emily Anthes about checklists in Nature notes:

Poor use of checklists means that people may be dying unnecessarily. A cadre of researchers is . . . finding a variety of factors that can influence a checklist's success or failure, ranging from the attitudes of staff to the ways that administrators introduce the tool. The research is part of the growing field of implementation science, which examines why some innovations that work wonderfully in experimental trials tend to fall flat in the real world. The results could help to improve the introduction of other evidence-based programmes, in medicine and beyond.

Totally predictable, as Captain Sullenberger noted over four years ago:

A checklist alone is not sufficient. What makes it effective are the attitude, behavior and teamwork that go along with the use of it.

Silent sovereigns of the forest

In Travels with Charley, John Steinbeck portrays the physical and emotional grandeur of the great West Coast trees:

The redwoods, once seen, leave a mark or create a vision that stays with you always.  No one has ever successfully painted or photographed a redwood tree. The feeling they produce is not transferable. From them comes silence and awe. It's not only their unbelievable stature, nor the color which seems to shift and vary under your eyes, no, they are not like any trees we know, they are ambassadors from another time. They have the mystery of ferns that disappeared a million years ago into the coal of the carboniferous era. They carry their own light and shade. The vainest, most slap-happy and irreverant of man, in the presence of redwoods, goes under a spell of wonder and respect. Respect--that's the word. One feels the need to bow to unquestioned sovereigns.

And it persists even after their death. In a welcome break from hours of discussion about patient harm and clinical process improvement, our Telluride scholars made a visit to the Petrified Forest in Calistoga. There we saw massive trees that had been blown over by the St. Helena volcanic eruption 3.4 million years ago. Two-thousand-year-old trees were felled in an instant, then slowly petrified in the resulting ash.

Branch holes remained where limbs had been torn away by the volcano's force.

Rock-hard age rings, likewise, show the years of growth.

Even in their petrified form, these 300-foot trunks held us in awe. Steinbeck says:

There's a remote and cloistered feeling here. One holds back speech for fear of disturbing something--what? Can it be that we do not love to be reminded that we are very young and callow in a world that was old when we came into it? And could there be a strong resistance to the certainty that a living world will continue its stately way when we no longer inhabit it?

Ain't the way to die

Here's a different take on end-of-life issues from ZDoggMD.  Worth watching and perhaps using in your place to get the conversation started.

(Thanks to Dr. Susan Shaw in Saskatoon for the reference.)

An individual and organizational moral obligation

My buddy Jeff Thompson is stepping down as CEO of Gundersen Health System in a few months.  I have commented several times here on Jeff's leadership abilities, which are again demonstrated in a note he sent to his staff this week.  In simple, direct terms he reinforces the narrative that is at the heart of his hospital's purpose.  It could be the same purpose of any hospital in the world, but it is not often set forth so well.  An element of leadership is that the narrative is expressed in so eloquent and elegant a fashion--one that permits all recipients to feel ownership of the privilege and obligation they have been given.

Dear Colleagues,

We are experiencing many changes as an organization. Some are very exciting like Dr. Rathgaber taking over as CEO in September. Others are more of a struggle. There is always going to be change, especially in our business.

But it is not the changes that are the most important.  It is how we respond. How we respond to change as individuals, teams and as an organization is what defines us. It will determine our futures and move us from good to great.

Sounds good, but change can be very scary.

Here’s what won't change: Our mission to improve care, lower cost and improve the health of the community. This rises beyond growth targets, financial goals and facilities plans. It really is an individual and organizational moral obligation.

To take on big responsibility and big changes, it is best to start with a great platform as a base. The solid platform we have should give us great confidence going forward.  In the face of higher quality standards, economic down turns, tons of regulation and increasing competition, you as teams and we as an organization have steadily improved on all of our key strategies.

Going forward it boils down to just a couple of really big things: Take care of our patients and take care of each other.  The "patient" part has expanded to "patients, families and communities" and each other needs to include those well beyond our immediate work groups to colleagues and partners.

Although changes will always cause some struggles, we have no reason to fear them. We need to trust our strong platform, our clear path and a great team to not just survive but truly excel through the change.

I know we are up for the challenges.

Sincerely,

When CEO bonuses are tied to US News rankings

Here's a quiz.  Can you guess who posted the following messages on Twitter?

Any idea how many hospital execs' bonuses are tied to their institution's U.S. News rankings?

When execs confide this arrangement, they expect me to be impressed or flattered. Are you kidding? I'm deeply disturbed.  

In my view it's a symptom the board has abdicated its responsibility to measure, monitor & incentivize quality improvement.

You might be surprised to learn that it was Ben Harder, @benharder, chief of health analysis at US News and World Report, the magazine that publishes "data, rankings & tools to help consumers choose hospitals, doctors, health plans & more."

Probably more than anyone in the country, Ben understands the inherent limitations in any such rankings. More important, he understands that the rankings are designed to advise patients with complex medical conditions.  They are not an indication about the general level of quality of care or safety in an institution.

He certainly knows that hospitals use the rankings in their marketing materials, but he understands that what makes marketing effective is different from what makes it possible for a hospital to deliver the highest level of care and to engage in ongoing clinical process improvement.

Bravo to Ben for putting this out there so clearly. I'm hoping board members take note.

Student observations from Telluride West

Here are some excerpts from just a few blog posts written by medical and nursing students after the first day the Napa version of the Telluride Patient Safety Camp (seen here having lunch!)  I encourage you to read others:

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They would act as though nothing is wrong.

I wrote this quote down on my pad during the Lewis Blackman video that was shown today because I’ve been guilty of this during rotations myself. Hellen Haskell, Lewis’ mother, was talking about the nurse taking care of her son and the fact that nursing notes ultimately revealed that she was indeed deeply concerned about the patient and his deteriorating clinical condition.

 

The truth is I don’t quite know how to act (maybe act is the wrong word) or rather what emotions to show around families. No one ever tells you to show a impassive face, to act as if everything is proceeding according to plan even when your team is struggling to figure out what is wrong, yet this is exactly what one learns observing the behavior of residents and attendings.

 

I suppose I always assumed that it was more comforting for families to feel like the providers had a handle on the situation. However, having heard from the patient and patient family perspective, I recognize how isolating and invalidated it can be to feel as if you are the only one concerned about your loved one’s care. While there is a time, a place, and an extent to which to share one’s emotions with patients and their families, honest communication throughout a patient’s stay can create a foundation of trust that can be critical in the terrible event an adverse outcome occurs.  (Neelaysh Vukkadala)

 

--

 

We started the day with the Lewis Blackman story. It was a very sobering, raw look at what healthcare should not be. Everything that could go wrong did in this case. No one could see the forest for the trees. I felt sad as a provider, devastated as a parent and could not imagine the strength that Helen has to go on and share this with others.

The whole story reminded me of my mother in law (who had cancer). She had epigastric pain & went to the ER. She was told she was constipated from her pain meds-and they missed her massive MI. Mom walked into the ER but never walked out. She lived the rest of her days (2 months) in a nursing home since she could no longer care for herself due to the injury from the missed MI.  She ultimately died from heart failure shortly after her MI-not the cancer she had been battling. We thought she would be with us for about another year-but we got that time stolen from us. In our case, my husband and I talked and decided not to pursue legal action since we knew she likely did not have much time left. He approached someone who he was friends with in hospital administration and let him know about the missed MI. He told him that he didn’t plan to pursue any legal action but did want to talk about how this could be avoided in the future. The guy he thought was his friend suddenly did not take his calls anymore. How sad. There are far too many stories like this.  (Tanya Celia)

--

Throughout the day, I couldn’t help but keep thinking about the importance of communication between the healthcare team and the patients that they serve. If there is no transparency, patients and their loved ones (even those well-versed with the medical system) feel like they are left in the dark — during the most stressful time of their lives, they have the added burden of trying to figure out what it is their doctors, nurses, and auxiliary team are actually doing. Lewis Blackman’s story is powerful in that it illustrates the importance of honesty. Watching the video left me with so many ‘if; statements. If the resident or intern working with the nurses had taken pause to discuss Lewis’s worsening condition, could this all have been avoided? What if the doctors and nurses had been more upfront about their lack of understanding of Lewis’s situation? What if Helen had been able to directly contact the attending, would he/she have listened to her pleas and ordered tests to reveal the ulcer? What if there had been a system implemented in the EMR to alert attendings when vital signs were out of whack? As an engineer by training, I believe we should create a framework so that even when humans make mistakes, the system in which we operate is able to provide a safety net to catch that one mistake that could mean life or death.  (Sunny Kung)

---

As students of medicine, we are constantly learning: from understanding how to create a robust differential diagnosis, to figuring out ways to chart a patient’s progress through an electronic health record. We drink thousands of new words from a firehose every day, hoping to eventually master the mesmerizing and powerful medical language. With this constant influx of new information, it is easy to forget perhaps the most important facet of our patients’ care: a meaningful relationship founded upon trust. Regardless of the hours spent memorizing biochemistry textbooks, if we as health care professionals cannot find a way to communicate with our patients, we will fail to provide our patients with high quality care. (Serena Dasani)

--

The general feeling I left the end of Monday with was discomfort. The idea that I will be taking the reins on patient care in three short years is a terrifying thought. I hope that I can draw on lessons from Telluride to remember to stay goal oriented, patient centered, and most of all scared in order to provide safe, quality care. (Alexandra Butz)

--

The corridor faded as her trust weakened
Ending a life, hopes, and dreams
Learning to cope with how we failed her
Leaving her impressions fluid in the rigid system
Unavailable.
Rising and challenging us to remember the center
Instill our pledge in our actions
Demanding change to our discussions
Establishing humanity in our calling  (Natalie Elder)

Yes, even surgeons can learn

The Risk Management Foundation of CRICO recently supported a research program to test the effectiveness of 360 degree reviews in influencing surgeons' communication and behavioral skills.  The results were just published in the Journal of the American College of Surgeons.

The context was important:

The program was deployed as part of a long-standing, surgical chief-led patient safety and quality collaborative. The collaborative had previously constructed a Code of Excellence (COE), an explicit description of behaviors expected of all surgeons within their departments. The 360 degree evaluation process was designed to assess progress towards these standards.

Here's how the study was designed:

Three hundred and eighty five surgeons in a variety of specialties [in the Harvard hospitals] underwent 360-degree evaluations with a median of 29 reviewers each. Beginning six months after evaluation, surgeons, department heads, and reviewers completed follow-up surveys evaluating accuracy of feedback, willingness to participate in repeat evaluations, and behavior change.

Here are the results:

Survey response rate was 31% for surgeons, 59% for department heads and 36% for reviewers. Eighty seven percent of surgeons agreed that reviewers provided accurate feedback. Similarly, 80% of department heads felt the feedback accurately reflected performance of surgeons within their department. Sixty percent of surgeon respondents reported making changes to their practice based on feedback received. Seventy percent of reviewers elt the evaluation process was valuable with 82% willing to participate in future 360 degree reviews. Thirty two percfent of reviewers reported perceiving behavior change in surgeons.

And the conclusions:

360-degree evaluations can provide a practical, systematic, and subjectively-accurate assessment of surgeon performance without undue reviewer burden. The process was found to result in beneficial behavior change according to surgeons and their co-workers.

"This is bad for academic medicine"

When the history of the patient safety movement is told, it will be appropriate that the Association of American Medical Colleges* will be left out.  The recalcitrance of this organization in acknowledging patient safety problems was legendary for the first decade of this century. The AAMC's leadership not only refused to acknowledge the depth of patient harm but also precluded use of the organization's arms in working on the issue.

For example, when an AAMC committee was to be established in the mid-2000's on patient quality and safety issues, the leadership insisted that the word "safety" be omitted from the committee's name and charter.

For example, when people would submit articles on patient safety to the AAMC's main journal, Academic Medicine, they would be summarily refused, refused even the courtesy of peer review.  The authors were told that patient safety was not an issue of public concern and therefore did not warrant space in the journal.

For example, at sessions with the world's experts on patient safety and doctor education (like Don Berwick and Lucian Leape), high officials from AAMC would reiterate their belief that hospitals did not have a patient safety problem.

Things finally changed in 2010, when a new CEO arrived.  In an article, he and the organization's president addressed the issue:

In order to develop a health care culture of safety that leads to clinical improvements, an unprecedented collaboration between medical schools and their partnering health systems is required, according to Drs. Kirch and Boysen. They identify five factors critical to the success of a culture shift: leadership from the top, student involvement, a focus on safety during residency training, health information technology, and teamwork among health professionals. “When combined with a growing investment in comparative effectiveness research, these factors will help physicians improve care at the bedside,” the authors write.

I suppose better late than never, but think about the societal loss caused by the absence of the major academic medical organization from this issue for so long--notwithstanding important findings by the Institutes of Medicine on the topic.

Perhaps the AAMC leadership reflected the views of its membership.  I recall, when I was emphasizing patient harm on this blog and posting clinical outcome data, the Chair of the Partners Healthcare System called the Chair of our system and said, "Can you get Paul to stop publishing those numbers.  This is bad for academic medicine."

Or perhaps the membership took direction from the AAMC leadership, who, after all, were highly regarded in the profession.  Either way, the lack of action on and attention to patient safety was a significant failure and led to the slow inclusion of patient safety curricula in America's medical schools. Let's consider, therefore, that the AAMC contributed for years to the delay in addressing the large number of preventable deaths and harm in America's hospitals.

--

* As noted in its materials: The Association of American Medical Colleges is a not-for-profit association representing all 144 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 51 Department of Veterans Affairs medical centers; and nearly 90 academic and scientific societies. Through these institutions and organizations, the AAMC represents 148,000 faculty members, 83,000 medical students, and 115,000 resident physicians.

Telluride goes to Napa

A hearty welcome to the newest participants in the Telluride Patient Safety Summer Camps, taking place this week in Napa, CA.  Here's a sample of the medical students and nursing students who are attending:

Man has to have feelings and then words before he can come close to thought

Back in 1962, John Steinbeck published Travels with Charley, a series of stories and observations from interactions with people across America.  I happened to pick it up yesterday to re-read it, about 50 years after the first time it was assigned to me in junior high school.  Early in the book Steinbeck relates a discussion he has with a New Hampshire farmer about what was still a major post-World War II concern, the recent development and spread of nuclear power and weapons.

The farmer says,

"Take my grandfather and his father.  They knew some things they were sure about. They were pretty sure give a little line and then what might happen.  But now--what might happen?"

"I don't know," responds the author.

"Nobody knows. What good's an opinion if you don't know. My grandfather knew the number of whiskers in the Almighty's beard. I don't even know what happened yesterday, let alone tomorrow. He knew what it was that makes a rock or a table. I don't even understand the formula that says nobody knows. We've got nothing to go on--got no way to think about things."

The farmer leaves and Steinbeck reports (my emphasis):

"I found I couldn't read, and when the light was off I couldn't sleep.  The clattering stream on the rocks was a good reposeful sound, but the conversation of the farmer stayed with me--a thoughtful articulate man he was. I couldn't hope to find many like him. And maybe he had put his finger on it. Humans had perhaps a million years to get used to fire as a thing and as an idea. Between the time a man got his fingers burned on a lightning-struck tree until another man carried some inside a cave and found it kept him warm, maybe a hundred thousand years, and from there to the blast furnaces of Detroit--how long?

"And now a force was in hand how much more strong, and we hadn't had time to develop the means to think, but man has to have feelings and then words before he can come close to thought and, in the past at least, that has taken a long time."

Now, look at this article about genetic engineering from Wired.  Excerpts:

140 scientists gathered here in 1975 for an unprecedented conference. They were worried about what people called “recombinant DNA,” the manipulation of the source code of life. It had been just 22 years since James Watson, Francis Crick, and Rosalind Franklin described what DNA was.

Preeminent genetic researchers like David Baltimore, then at MIT, went to Asilomar to grapple with the implications of being able to decrypt and reorder genes. It was a God-like power—to plug genes from one living thing into another. Used wisely, it had the potential to save millions of lives. But the scientists also knew their creations might slip out of their control. They wanted to consider what ought to be off-limits.

At the end of the meeting, Baltimore and four other molecular biologists stayed up all night writing a consensus statement. They laid out ways to isolate potentially dangerous experiments and determined that cloning or otherwise messing with dangerous pathogens should be off-limits. A few attendees fretted about the idea of modifications of the human “germ line”—changes that would be passed on from one generation to the next—but most thought that was so far off as to be unrealistic. Engineering microbes was hard enough. The rules the Asilomar scientists hoped biology would follow didn't look much further ahead than ideas and proposals already on their desks.

But then:

Earlier this year, Baltimore joined 17 other researchers for another California conference. The stakes, however, have changed. Everyone at the Napa meeting had access to a gene-editing technique called Crispr-Cas9, [which] makes it easy, cheap, and fast to move genes around—any genes, in any living thing, from bacteria to people. “These are monumental moments in the history of biomedical research,” Baltimore says. “They don't happen every day.”

Using the three-year-old technique, researchers have already reversed mutations that cause blindness, stopped cancer cells from multiplying, and made cells impervious to the virus that causes AIDS. Agronomists have rendered wheat invulnerable to killer fungi like powdery mildew, hinting at engineered staple crops that can feed a population of 9 billion on an ever-warmer planet. 

Bioengineers have used Crispr to alter the DNA of yeast so that it consumes plant matter and excretes ethanol, promising an end to reliance on petrochemicals. Startups devoted to Crispr have launched. International pharmaceutical and agricultural companies have spun up Crispr R&D. Two of the most powerful universities in the US are engaged in a vicious war over the basic patent. Depending on what kind of person you are, Crispr makes you see a gleaming world of the future, a Nobel medallion, or dollar signs. 

The technique is revolutionary, and like all revolutions, it's perilous. Crispr goes well beyond anything the Asilomar conference discussed. It brings with it all-new rules for the practice of research in the life sciences. But no one knows what the rules are—or who will be the first to break them.

Now, think back to Steinbeck:

"And now a force was in hand how much more strong, and we hadn't had time to develop the means to think, but man has to have feelings and then words before he can come close to thought and, in the past at least, that has taken a long time."

In the past, it was the military-industrial complex, now it's the medical-industrial complex. Driven by ego of people who are too sure of themselves and the greed of those seeking to park their cash, the likelihood of effective and thoughtful controls is likely to proceed at too slow a rate to protect us from ourselves. Now here's an issue worthy of attention by the multitude of presidential candidates: Will any step up to address it?