Affidavit of Jonathan Burroughs, MD, MBA, FACHE, FAAPL

Regarding General Principles of Healthcare Administration

PERSONALLY APPEARS before the undersigned authority, duly authorized to administer oaths, comes Jonathan Burroughs, who after first being duly sworn, states as follows:

Introduction

1.             This affidavit addresses general principles of healthcare administration.

2.             This affidavit does not address any specific healthcare facility. Nor does it address the care of any specific patient.

3.             The way healthcare facilities are managed is not obvious or intuitive.

4.             Even clinicians with years of experience in a facility may have limited knowledge of how that facility is administered.

5.             Because most adults will have significant experience with healthcare as patients or consumers, it is possible to have gut or “common sense” intuitions about healthcare administration that are strong, but wrong.

6.             The purpose of this affidavit is to provide a sense of the reality of healthcare administration — a sense that is highly general but based on fact.

7.             Dan Holloway of Bell Law Firm drafted this affidavit after consulting with me. Mr. Holloway first drafted a statement of general principles of healthcare administration based on his reading of the relevant literature. He shared that statement with me, we discussed it, and he drafted this affidavit based on our discussion. I reviewed the draft and edited it for substance, to make sure it correctly states my substantive views. I have not edited this affidavit for style.

8.             I understand that Mr. Holloway has asked providers from a variety of backgrounds to address these issues. Because the general principles are general, I would expect most if not all informed individuals to agree with these principles.

My Perspective on Healthcare Administration

9.             I was an Emergency Medicine Physician, I have an MBA, I have served as a mid-level and senior healthcare executive for sixteen years, I have worked as a healthcare administrative consultant and expert for almost two decades, I have served on a healthcare governing board for nine years, I have edited and authored multiple books on healthcare administration, I have served on the faculties of the American College of Healthcare Executives (ACHE) and the American Association for Physician Leadership (AAPL) for almost a decade and have created nine national programs for these organizations, and I am currently in law school.

10.          I have served as Emergency Department Medical Director (1982-1988, 2006-2008), Past President of the Medical Staff (2004-2008), President of the Medical Staff (2000-2004), Member (ex-officio and regular) of the Board of Trustees (2000-2008), and Chair (2000-2004) and Member of the Medical Executive Committee (2000-2008). In my role as President of the Medical Staff, I created the Chief Medical Officer (CMO) position at my healthcare organization. As a healthcare administrative consultant, I have worked with over 1,500 healthcare organizations and systems and participated in over 172 legal cases as a healthcare administrative expert.

11.          I edited and partly authored the book Essential Operational Components for High-Performing Healthcare Enterprises, which won the 2020 James A. Hamilton Book of the Year Award from the American College of Healthcare Executives. I authored the book Redesign the Medical Staff Model: A Guide to Collaborative Change, which won the 2016 James A. Hamilton Book of the Year Award from the American College of Healthcare Executives.

12.          Through my work, I have experience of the ways in which non-clinician administrators impact patient safety, operations, quality, and financial performance, and also of the interactions between those administrators and frontline clinicians.

13.          My CV is attached to this affidavit.

Literature

14.          There is a large literature on healthcare administration and patient safety. The following books are only a handful of the relevant sources:

a.    The Joint Commission, Comprehensive Accreditation Manual for Hospitals.

b.    Institute of Medicine, To Err is Human: Building a Safer Health System (2000).

c.     Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century (2001).

d.    Charles Vincent, Patient Safety, 2d Ed. (Wiley-Blackwell, 2010).

e.     Patrice L. Spath, Error Reduction in Health Care, 2d Ed. (Jossey-Bass, 2011).

f.      Robert Wachter, Understanding Patient Safety, 3d Ed. (McGraw Hill, 2018).

g.    Lucian Leape, Making Healthcare Safe (Springer, 2021).

Bottom Line

15.          Preventable medical error is a major cause of death in the United States. It is difficult to know how many deaths are caused by medical errors, but one widely cited estimate ranks medical error as the third leading cause of death in America — with over 1,000,000 preventable deaths and 4,000,000-5,000,000 preventable injuries in the United States alone.

16.          Healthcare administrators consist largely of individuals who are not licensed healthcare providers. Non-clinician healthcare administrators may be highly knowledgeable about various aspects of healthcare, but they are not licensed medical professionals although they may have practiced medicine or still practice some aspect of medicine in their administrative roles.

17.          Medical errors usually arise from a combination of two general factors: (a) systemic problems that create unreasonable potential for error, and (b) failings by individual clinicians within that system.

18.          A primary job of non-clinician administrators is to support clinicians by providing systems that facilitate proper medical care and actively prevent medical error — to set clinicians and patients up for success rather than failure. We understand today that human error is inevitable and that therefore we need to create patient safety systems that prevent inevitable human errors from reaching a patient and causing harm.

19.          When non-clinician healthcare administrators do their work negligently, they can foreseeably contribute to medical errors that hurt patients. Patient Safety looks now to systemic issues as the primary cause of harm to patients, because safety barriers can be created to prevent inevitable human errors from reaching the patient.

20.          Some healthcare institutions persist in attributing medical error solely to clinicians — refusing to acknowledge any contribution to error from the work of non-clinician administrators. This mentality is dangerous: It perpetuates system-level problems that promote medical error and hurt patients.

21.          Most states recognize that hospitals and healthcare systems have an independent duty to patients to create safe systems that meet a minimum administrative standard of care.

Discussion

The Complexity of the System & the Risk of Medical Error

22.          A hospital is a large, complex system and is often part of an even larger, more complex healthcare system.

23.          Care of a hospital patient frequently involves multiple people in varying roles — for example, physicians, “advanced-practice” providers, nurses and nursing assistants, “technology” staff (e.g., X-ray technicians), and support staff including secretarial, housekeeping, food service, and so on. 

24.          The clinical staff are overseen by medical staff leaders, medical and nursing directors, chief medical officers, chief nursing officers, chief operating officers, chief financial officers, and chief executive officers.

25.          Care of a hospital patient often involves multiple physicians in a variety of practice areas — for example, internists, radiologists, neurologists, pulmonologists, surgeons of various kinds, etc. 

26.          Typically, care of a multi-day hospital patient is handed off multiple times from one physician to another, and from one nurse to another and from one technologist and clinical documentation professional to another.

27.          Typically, individual physicians and nurses in a hospital have multiple patients. 

28.          The complexity of hospital care creates potential for medical errors of various kinds of sources — for example, inattention, failures of communication, lack of preparedness, mistaken assumptions that someone else is addressing a problem, and others. 

29.          Many types of healthcare system failures are known and predictable — for example, miscommunication during patient hand-offs, silo-ing of responsibilities, cognitive biases, overwork or understaffing, organizational cultures that discourage raising concerns about patient safety, etc.

30.          One primary role of healthcare administrators — including non-clinician administrators — is to anticipate vulnerabilities in the systems of care, and to put guardrails or safety barriers in place to prevent errors that hurt patients.

31.          Safety barriers include such things as: good hiring practices, orientation, training, supervision, good policies and procedures that are promulgated, safety alarms, decision support tools, electronic alerts, critical results communication protocols, rapid response teams, etc.

System-Level Solutions to System-Level Problems

32.          Human error can be reduced by well-designed systems.

33.          System failures in healthcare organizations can be reduced by a culture of safety and a program of continuous improvement.

34.          Errors that cause serious harm can be reduced or eliminated by managing the manageable — the organizational factors lying within the direct spheres of influence of system managers.

35.          For decades, governmental and private organizations have worked to find solutions to healthcare system failures, and to make tools available to hospitals to address system failures.

36.          Much of the research on patient safety is based on general research into error prevention in “High-Reliability Organizations” (HRO’s) — organizations like commercial airlines or nuclear power plants. These organizations are highly complex, and errors can kill large numbers of people, but HRO’s work towards achieving zero or near-zero rates of harm-causing error in high performing systems.

37.          Examples of other industries where these practices have been successful include the: airline, nuclear regulatory, military, and other high risk industries and practices.

38.          Patient safety efforts involve two broad, overarching components — (a) continuous process improvement and (b) a culture of safety. Both components are supported, and to some extent required, both by the Medicare system and by the Joint Commission, the primary healthcare-accrediting organization in the United States.

39.          Continuous process improvement can go by a variety of names. Broadly, though, it refers to a formal, actively managed process of continually working to expose system vulnerabilities and to fix them before they lead to patient harm.

40.          Continuous process improvement can involve a variety of management methods that have been developed in various industries and have been heavily studied. These management methods include “Lean,” a management process derived from the management of Toyota, and “Six Sigma,” a management process developed at Motorola. 

41.          A “culture of safety” refers to a set of pro-safety beliefs, commitments, and actions shared throughout an organization, from the CEO and Board of Directors down to frontline staff.

42.          These two overarching components of a patient safety program have led to the development of many specific actions to protect patient safety.

Management as a Distinct Discipline

43.          Managing or administering a healthcare organization is not the same as practicing medicine or nursing. Management or administration involves different roles, different actions, different responsibilities. 

44.          Management of organizations is a specialized discipline, with its own field of study, its own set of theories and historical development, its own education and training requirements.

45.          Healthcare administrators need education, training, and skills different from those required to be a physician or nurse. Non-clinician administrators must have education or training in management, but need not have gone to medical or nursing school. Physicians or nurses need not have training in managing organizations.

46.          It is now widely recognized that faulty systems have a greater impact upon patient outcomes than the actions of individual clinicians. Systems not only inform but control for what clinicians are obligated to do with respect to patient care.

The Fact of Non-Clinician Administrators’ Responsibility for Patient Safety

47.          Typically, the majority of the governing board of a healthcare system is comprised of individuals who are not licensed healthcare professionals.

48.          Typically, the executive officers of a healthcare system (often including the chief executive officer) include individuals who are not licensed healthcare professionals.

49.          Typically, the administrative staff of a healthcare system includes many individuals who are not licensed healthcare professionals.

50.          The governing body of a healthcare organization or system is legally accountable for the quality of care provided by licensed clinicians.

51.          The governing body delegates responsibility and accountability to its management team through the CEO and to the organized medical staff through the President of the Medical Staff and the Medical Executive Committee (MEC).

52.          The Joint Commission’s accreditation standards hold healthcare administrators and board members responsible for oversight of medical care and patient safety.

53.          Management of the safety and quality of care in a healthcare system is the direct responsibility of leaders — including non-clinician administrators.

·      Joint Commission, Comprehensive Accreditation Manual for Hospitals (2022)

The Importance of Non-Clinician Administrators’ Responsibilities for Patient Safety

54.          No clinician is in a position to prevent all risks of medical error that patients are exposed to.

55.          Clinicians treating patients typically are not in a position to fix problems with the systems and organizational culture in a healthcare organization. 

56.          The healthcare system is controlled and operated by healthcare administrators as overseen by the Chief Executive Officer and the Board of Trustees.

57.          When hospitals perform a root cause analysis of medical error that harmed a particular patient, the chain of causation significantly leads back to system or cultural failures for which non-clinician administrators are responsible.

58.          A healthcare organization’s leadership — including non-clinician administrators — plays an essential role in protecting patients from medical error.

·      Joint Commission, Sentinel Event Alert, Issue 57 (March 1, 2017).

…

59.          Negligence by non-clinician administrators can promote medical error and contribute to patient harm.

·      Joint Commission, Sentinel Event Alert, Issue 57 (March 1, 2017).

What Administrators Do

Guiding Principles

60.          Patient safety has developed into a specialized discipline based on decades of research into the causes of human error and systems error generally, across multiple industries.

61.          While patient safety relates to healthcare, patient-safety staff do not need to be licensed healthcare professionals, and frequently they are not.

62.          The core principles of patient safety include the following:

a.    Zero harm from medical error is achievable. A healthcare organization can become a “High-Reliability Organization,” meaning it achieves zero or near-zero serious harm to patients from medical error.

b.    Prevention of harm from medical error requires a healthcare organization to set patient safety as a major goal of the governing board and CEO, and to create an administrative structure dedicated to patient safety.

c.     Some amount of human error is unavoidable, but human error can be limited by a variety of means, including automation of select tasks, standardization of select workflows, and training on general causes of error and prevention of error.

d.    The key point is that inevitable human error does NOT have to ever reach a patient if appropriate safety barriers and systems are in place.

e.     Diligently designed systems (including policies & procedures, standardized workflows, etc.) actively prevent medical error. Poorly designed systems promote error and cause harm.

f.      Errors that occur despite diligently designed systems can be exposed and corrected before they cause harm.

g.    Prevention of harm from medical error requires a culture of safety — a set of attitudes and expectations shared throughout the entire organization, which actively work to expose errors before they cause harm.

h.    A healthcare organization must be a “learning organization” that engages in continuous improvement. It must continuously engage in formal quality improvement projects and use exposure of errors to reduce vulnerabilities in the systems.

i.      Because patient care typically involves multiple individuals, well-designed communication systems and protocols are essential to patient safety.

j.      Properly trained and prepared staff are essential for patient safety. This requires not only meeting the minimal requirements for licensing: It requires training and preparation for the specific roles the respective staff members serve.

k.    Proper staffing and morale are essential for patient safety. Poor staffing or morale can undermine or defeat many pro-safety efforts.

63.          Much of the work of a healthcare organization’s patient-safety function is purely administrative and can be done only by administrators.

System-Building & Management

64.          Most simply, the senior administrators (the governing board and CEO) are responsible for creating systems to promote patient safety, and then managing those systems — to oversee processes to decide what needs to be done, to make sure it gets done, and to coordinate the actions of the dozens or hundreds or thousands of personnel in a healthcare organization.

65.          The creation and management of the patient-safety function is critical, because work not assigned and managed is apt to go undone.

66.          Purely administrative patient-safety work includes creating an administrative structure to take primary responsibility for patient safety — creating an executive-level position for patient safety, and creating the number and type of patient-safety administrative staff necessary for the healthcare organization’s particular needs.

67.          Purely administrative patient-safety work includes creating and maintaining a process for continuously promoting a culture of safety throughout the organization.

68.          Purely administrative patient-safety work includes managing a process for formal, actively managed quality improvement projects.

69.          Purely administrative patient-safety work includes managing a process to ensure that personnel are trained and prepared for the roles they occupy.

70.          Purely administrative patient-safety work includes managing a process to ensure the healthcare system is implementing practices that protect patients. Just papering the file is not enough. Policies must not only be created: They must be actively promulgated, supervised, and enforced.

Intermediate Level

71.          At an intermediate level of description, patient-safety efforts include the following non-exhaustive lists.

72.          As to a culture of safety, purely administrative responsibilities include the following broad tasks:

a.    Commit to develop, communicate, and follow through on an organizational vision of zero harm.

b.    Establish organizational behaviors that lead to respect for, and inclusion of, all staff throughout the organization, regardless of rank, role, or discipline.

c.     Select and develop the board so it has clear competencies, focus, and accountability regarding safety culture.

d.    Educate and develop leaders at all levels of the organization who embody organizational principles of safety culture.

e.     Build a culture in which all leaders and the workforce understand basic principles of patient safety science, and recognize one set of defined and enforced behavioral standards for all individuals in the organization.

f.      Create one set of behavior expectations that apply to every individual in the organization and encompass the mission, vision, and values of the organization.

73.          The foregoing work sounds simple and soft, but requires major, sustained effort. Without effort, a culture of safety cannot be maintained. And without a culture of safety, the best patient-safety strategies fail. As management theorists say, culture eats strategy for breakfast.

74.          As to specific safety or quality improvement projects, purely administrative responsibilities include the following non-exhaustive list:

a.    Manage the project — assign it, oversee it, make sure it gets done, follow up on it.

b.    Provide personnel who are knowledgeable about patient safety science and its various methods, to lead or assist in improvement projects.

c.     With involvement of patient-safety staff together with clinical staff, chart out the relevant workflows.

d.    With involvement of patient-safety staff together with clinical staff, analyze potential vulnerabilities and improvements.

e.     With involvement of patient-safety staff together with clinical staff, create a plan for improved processes.

f.      With support from patient-safety staff, implement the plan in a pilot project.

g.    With involvement of patient-safety staff together with clinical staff, collect data on the pilot project, and resume the improvement cycle.

h.    With involvement of patient-safety staff together with clinical staff, spread the improved process through all relevant areas of the organization.

75.          As to system vulnerabilities that could cause serious harm, purely administrative responsibilities include the following non-exhaustive list:

a.    Provide patient-safety staff to assist in analyzing system vulnerabilities.

b.    With involvement of patient-safety staff together with clinical staff, analyze the nature and causes of the system vulnerability using a method validated as effective (e.g. Failure Mode and Effects Analysis).

c.     With involvement of patient-safety staff together with clinical staff, work through the process-improvement cycle.

d.    With involvement of patient-safety staff together with clinical staff, spread the improved process throughout the organization.

76.          As to errors that have already caused serious harm — “sentinel events” — the responsibilities of administrators include the following non-exhaustive list:

a.    Provide policies and training on identifying and reporting sentinel events.

b.    Create an interdisciplinary team supported by patient-safety staff to assist in analyzing the causes of the adverse event.

c.     With involvement of patient-safety staff together with clinical staff, analyze the nature and causes of the adverse event using a method validated as effective (e.g. root cause analysis).

d.    With involvement of patient-safety staff together with clinical staff, work through the process-improvement cycle.

e.     With involvement of patient-safety staff together with clinical staff, spread the improved process throughout the organization.

77.          Much of the work described above involves both non-clinical administrators and healthcare professionals, working together in various ways. The work of both types of staff is integral, essential, and non-redundant. Neither type of staff can do it alone. And negligence by either type will undermine the project.

Interaction of Non-Clinician Administrators & Licensed Medical Professionals Regarding Patient Safety

78.          Depending on the nature of any given patient-safety task, non-clinician administrators work in varying ways with healthcare professionals:

a.    Administrator-driven action: In some tasks, administrators act essentially independently, with limited input from licensed medical professionals. For example, non-clinician administrators may independently decide to administer the “Hospital Survey on Patient Safety” produced by the US Agency for Healthcare Research & Quality. Administrators may seek input from healthcare professionals for certain aspects of the survey administration, but the survey primarily requires purely administrative work.

b.    Professional-driven action: Some tasks even at the administrative level consist mainly of professional work, with support from non-clinician administrators. For example, the content of protocols for stroke patients obviously resides in the domain of licensed medical professionals. But non-clinician administrators may play a facilitating role in the process of developing those protocols.

c.     Back-and-forth tasks: Non-clinicians and licensed medical professionals may work together on a project sequentially, passing the ball back and forth — an administrative task, then a medical task, then another adminstrative task, etc. In a simplistic scenario, for example, a CEO may direct the Chief Medical Officer (a physician) to assess and update policies for care of stroke patients in the Emergency Department. The CMO does the work and hands the policy to the CEO. The CEO has administrative staff promulgate the policy throughout the organization. Then the CEO directs the CMO to assess whether ED staff are properly trained on the updated policy and, if not, to create a training program. The CMO performs that work and reports back. The CEO then announces a training requirement and allocates time and resources for it. Then the CMO conducts the training.

d.    Joint collaboration: On some tasks, administrators may work jointly, simultaneously with clinicians. For example, a non-clinician administrator and a physician may work together to create a flowchart of an intubation procedure as performed in the ICU, as part of a patient-safety project.

e.     Hybrid projects: Large patient-safety projects may involve all of the different interaction types described above, in different ways, at different stages of the project.

79.          Again, the work of both non-clinicians and licensed medical professionals is integral, essential, and non-redundant. Negligence by either type of personnel will undermine or defeat the project.

Interaction of Non-Clinician Administrators & License Medical Professionals as to Medical Policies

80.          Concerning medical policies, non-clinician administrators are responsible for:

a.    making sure need-assessments are performed to identify what policies or protocols should be created,

b.    making sure policies and protocols are communicated effectively to healthcare system staff (instead of just papering the file),

c.     making sure training needs are identified and that needed training is given, so that healthcare system staff understand how to apply the policies and protocols in practice,

d.    making clear that the policies and protocols must be followed (that is, that they are not bureaucratic formalities which staff can disregard),

e.     monitoring compliance, and

f.      ensuring remedial actions are taken where compliance problems arise.  

Concrete Work Examples

81.          To provide a more concrete sense of purely administrative work on patient safety, here are a few essentially random examples:

a.    A healthcare organization’s CEO reads a book on patient safety.

b.    A CEO talks to the Board about creating a Board committee on patient safety to create and oversee an active, aggressive patient safety program.

c.     The executive officers of a healthcare organization disseminate the AHRQ Hospital Survey on Patient Safety Culture to system personnel, and then analyze the results.

d.    The executive officers conduct a weekly “safety walk” to hear from front-line clinicians.

e.     Health Informatics staff perform statistical analysis of data obtained through health IT systems to help identify common sources of medical error.

f.      The chief operating officer writes a policy for handling patient grievances, then emails it to department heads and schedules a meeting to discuss implementation.

g.    After receiving notice from a nurse of an unexpected adverse event — a heart attack that went untreated and killed a patient — a patient safety officer triggers the sentinel-event process.

h.    As part of a quality improvement project, a patient safety officer stands at a whiteboard alongside a physician, to jointly graph the workflow for responding to a patient with severe, acute chest pain.

i.      The chair of a healthcare system’s board types out a list of common sources of serious medical error. The chair then convenes a meeting of the board’s patient safety committee, to ask the healthcare system’s executive leadership what if anything the healthcare system is doing about those sources of error.

j.      At the direction of the chief medical officer, an administrative assistant schedules a meeting of the medical executive committee to address a report by a nurse that she was treated dismissively by a physician after raising a concern about one of the physician’s patients.

k.    The CEO directs the patient safety officer and the chief medical officer to perform a study of the healthcare system’s performance on nights and weekends.

82.          The list could be extended indefinitely, with tasks major and minor — all of which significantly impact patient safety.

Accountability for Hospital Administrators

83.          It would be wrong to hold doctors and nurses accountable for their negligence, but at the same time to exempt non-clinician administrators from accountability for their own negligence.

84.          It would be dangerous to exempt non-clinician administrators from accountability for their own negligence. That would remove an important incentive for them to work diligently to create systems that protect patients.

85.          Most state jurisdictions recognize the independent duty of hospitals and healthcare systems to the patient and to support reasonable systems in place to support clinical performance.

86.          As a healthcare administrative expert, I testify in multiple jurisdictions as to the causative role that both strong and weak systems have in causing or preventing inevitable human error from reaching a patient.

                                                                                    JONATHAN  H. BURROUGHS, MD, MBA, FACHE, FAAPL

SWORN TO AND SUBSCRIBED before me

_________________, 2022

____________________________________

NOTARY PUBLIC

My Commission Expires: