Quality Improvement and Accreditation

Overview

A Brief History of Quality Improvement in Health Care and Spinal Surgery

Kevin Hines, MD 1

, Nikolaos Mouchtouris, MD 1

, John J. Knightly, MD

2 , and James Harrop, MD

1

Abstract While medical and technological advances continue to shape and advance health care, there has been growing emphasis on translating these advances into improvement in overall health care quality outcomes in the United States. Innovators such as Abraham Flexner and Ernest Codman engaged in rigorous reviews of systems and patient outcomes igniting wider spread interest in quality improvement in health care. Codman’s efforts even contributed to the founding of the American College of Surgeons. This society catalyzed a quality improvement initiative across the United States and the formation of the Joint Commission on Accreditation of Hospitals. Since that time, those such as Avedis Donabedian and the Institute of Medicine have worked to structure the process of improving both the quality and delivery of health care. Significant advances include the defining of minimum standards for hospital accreditation, 7 pillars of quality in medicine, and the process by which quality in medicine is evaluated. All of these factors have affected current practice more each day. In a field such as spinal surgery, cost and quality measures are continually emphasized and led to large outcome databases to better evaluate outcomes in complex, heterogeneous populations. Going forward, these databases will be instrumental in developing practice patterns and improving spinal surgery outcomes.

Keywords Joint Commission on Accreditation of Healthcare Organizations, spinal cord injuries, outcome, National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division, quality improvement, cost, structure, process

While medical and technological advances continue to shape

and advance health care, these advances have not always

directly translated to significant improvement in overall health

care quality outcomes in the United States. Incorporating

advancements into the health care models creates complex

challenges in delivering high-quality medical care. In this arti-

cle, we provide a brief outline on the history of such efforts and

how they have changed health care systems.

Improving the quality of care rendered to patients has been a

principle since the time of Hippocrates. Over time, there have

been various advances in systems of care (Walter Letterman

developing systems of triage of casualties in the American

Civil War) as well as nursing (Florence Nightingale instilling

Listerean principles of infection control in hospitals). However,

the past century has seen many innovators and changes instru-

mental in the improvement in the quality of care in medicine.

Understanding these recent contributions to quality improve-

ment in health care frames future directions and emphasis in

complex fields such as spinal surgery.

Abraham Flexner is an early contributor to the United

States’ effort in quality improvement in that he performed a

retrospective analysis and review of the system. He constructed

a Report to the Carnegie Foundation, which were published his

results and recommendations in 1910. He described the poor

organization of major hospitals and medical schools in the

nation. With the aim of improving physician training, the report

encouraged improving scientific method, and strengthening

validity of medical licensure. This report resulted in

1 Thomas Jefferson University, Philadelphia, PA, USA

2 Atlantic Neurosurgical Specialists, Morristown, NJ, USA

Corresponding Author:

Kevin Hines, Department of Neurological Surgery, Thomas Jefferson

University, 909 Walnut Street, COB Building, 3rd Floor, Philadelphia, PA

19107, USA.

Email: [email protected]

Global Spine Journal 2020, Vol. 10(1S) 5S-9S ª The Author(s) 2020

Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/2192568219853529

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A Brief History of Quality Improvement in Health Care and Spinal Surgery

Global Spine Journal 2020, Vol. 10(1S) 5S-9S The Author(s) 2020 Article reuse guidelines:

Abstract

Keywords

Email: [email protected]

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restructuring of the medical education in the United States and

resulted in the closure or merging of more than half the medical

schools. 1

Meanwhile, Ernest Codman, an orthopedic surgeon from

Boston, Massachusetts was championing changes for quality

improvement through the use of patient registries and serial

patient follow-up. He created a systematic protocol for follow-

ing long-term patient progression and “end patient results.”

Codman felt that all patients should be tracked in this manner

and results be made public so that all patients could use the

information in choosing their physicians and hospitals. While

public reporting such as this may have incentivized hospitals to

preselect patients to avoid bad results, Codman’s emphasis was

largely placed on identifying effective versus ineffective

implementation of health care treatments. 2

Codman’s description of his end-result system inspired

Dr Franklin Martin. He envisioned principles of patient out-

comes assisting in surgeon and hospital standardization leading

to an improvement in patient care. To address these needs, Dr

Martin largely proposed and catalyzed the founding of the

American College of Surgeons in 1913. The committee found

it necessary to reject 60% of fellowship applications in its first 3 years of existence given the inability to determine clinical

competency with the case records presented by the applicants. 3

As the American College of Surgeons’ influence increased,

John Bowman, PhD, the director acquired a large donation to

fund a hospital standardization program. Over 300 fellows and

hospital administrators met in 1917 to discuss an accreditation

process and establish the ”minimum standards” required of

hospitals nationwide. 4

Such standards included 5 main objec-

tives: organize hospital medical staff, ensuring employment of

only well-qualified and licensed physicians, ensuring regular

staff and clinical performance review, maintaining thorough

and organized medical records, and establishing facilities such

as clinical laboratories and radiology departments (Figure 1).

Using these principles, the Hospital Standardization Program

was established and reviewed 692 hospitals with 100 beds or

more. Unfortunately, only 89 hospitals met these minimum

standards for accreditation. While many hospitals were able

to remediate and address their deficiencies, the report demon-

strated the continued need for quality improvement in the

United States’ hospital system and the “minimum standard”

was officially adopted to firmly establish a hospital accredita-

tion process. This was paramount in instituting and maintaining

organized quality improvement in the United States. 5

As the number of hospitals, nonsurgical specialties, and

complexity of health care continued to grow, the size of the

Hospital Standardization Program rapidly grew requiring over

2 million dollars in investment from the American College of

Surgeons by 1950. It became apparent that support for this

quality improvement initiative could not be sustained by the

College alone and the scope of its involvement extended to

many nonsurgical aspects of health care. As a result, the Amer-

ican College of Surgeons was joined by the American College

of Physicians, American Hospital Association, American Med-

ical Association, and briefly the Canadian Medical Association

to form the Joint Commission on Accreditation of Hospitals in

1952. The independent, nonprofit organization begin offering

accreditation to hospitals in 1953 while upholding the values

championed by the American College of Surgeons. The Joint

Commission expanded the Hospital Standardization program

by hiring surveyors and careful interviews and observation of

medical staff and patient care issues. As the program expanded

more hospitals continued to meet and maintain the “minimum

standards.” As a result, the Joint Commission no longer felt that

the standards were pushing hospitals to strive for higher levels

of quality than already achieved.

Concurrently, others in the nation were looking to further

quality improvement. Health Services Research Section of the

US Public Health Service convened a meeting in 1965 during

which leaders from many health-related fields convened to

discuss social and economic research on public health and

quality improvement. Among these leaders was Avedis

Donabedian, considered by many to be one of the founders

of the contemporary health care quality movement. 6

Born

1919, in Beirut, Lebanon, his family moved to Palestine after

fleeing the Armenian holocaust. Eventually attending

American University of Beirut, he obtained his BA and MD.

Using this training, he served as a general practitioner in Beirut

and Jerusalem until 1954 at which point he moved to Boston.

He obtained an MPH degree at Harvard School of Public

Health and spent most of his career teaching at the School of

Public Health at The University of Michigan. He was very

passionate about the relationship between quality and systems

in health care and felt that the skills of system management

were not well taught in medical school. 7

As such, he was com-

missioned to review the research on quality assessment. When

he published his paper “Evaluating the Quality of Medical

Care” in July 1966, the reception was enormous. It became one

of the most frequently cited public health pieces over the next

half century.

In his paper, Donabedian describes 7 pillars of quality in

medicine:

Figure 1. American College of Surgeons met in 1917 outlining the 5 main objectives of “minimum standards” required to meet accred- itation standards in hospitals nationwide.

6S Global Spine Journal 10(1S)

Concurrently, others in the nation were looking to further quality improvement. Health Services Research Section of the US Public Health Service convened a meeting in 1965 during which leaders from many health-related fields convened to discuss social and economic research on public health and quality improvement. Among these leaders was Avedis Donabedian, considered by many to be one of the founders of the contemporary health care quality movement. See endnote 6 on page 5. Born 1919, in Beirut, Lebanon, his family moved to Palestine after fleeing the Armenian holocaust. Eventually attending American University of Beirut, he obtained his BA and MD. Using this training, he served as a general practitioner in Beirut and Jerusalem until 1954 at which point he moved to Boston. He obtained an MPH degree at Harvard School of Public Health and spent most of his career teaching at the School of Public Health at The University of Michigan. He was very passionate about the relationship between quality and systems in health care and felt that the skills of system management were not well taught in medical school. See endnote 7 on page 5. As such, he was com- missioned to review the research on quality assessment. When he published his paper �Evaluating the Quality of Medical Care� in July 1966, the reception was enormous. It became one of the most frequently cited public health pieces over the next half century.

� Efficacy � Efficiency � Optimality � Acceptability � Legitimacy � Equity � Cost

The difficulty in the past was how to measure these goals.

To accomplish this, he described three types of metrics for

evaluating quality in health care: structure, process, and out-

come (Figure 2). Structure includes credentialing of providers,

adequacy of facilities, and administrative systems delivering

care. Process observes which components of care are delivered

and their appropriateness and competency of delivery. He

recognized that it is rarely the individual that creates the prob-

lem but rather the process is a fault and needs to be changed for

better results. Outcome involves evaluation of recovery,

restoration of function, and survival. Measuring outcomes is

necessary to determine what interventions are effective and

should be implemented. Within these standards, he emphasized

the need for clear presentation of these metrics (dashboards and

scorecards) and broad quality measurements, including preven-

tion, recovery, continuity of care, societal and cultural values,

and economic efficiency. This way physicians can begin to

truly understand evidence surrounding a problem and recog-

nize issues affecting health care quality. This also provided the

framework on which the interest in patient individualized out-

comes and value-based care was developed. 8

These advances largely structured health care improvement

quality for several decades. During this time, the Institute of

Medicine was founded in 1970 by the National Academy of

Sciences. Originally formed in 1863, the Academy, a nonprofit

private institution, was formed to advise the government on

scientific and technological issues. Over time, the scope of the

Academy’s responsibilities began to include medicine and dif-

ferent aspects of health care. After Avedis Donabedian published

his work, the concern over establishing a body advising the

government on issues regarding social, economic, and political

aspects of health care as well as medicine evolved. Out of this

need the Institute of Medicine was founded in 1970. The mem-

bers of this committee included not only major health profession

disciplines but also economists, sociologists, engineers, writers,

ethicists, and innovative business representatives with success in

areas related to health care issues in the United States. 9

Since its founding, the Institute of Medicine has continued

to produce field defining publications. As an organization, it

publishes roughly 50 well-vetted reports in medicine each year.

One such publication, America’s Health in Transition: Protect-

ing and Improving Quality, was published in 1994. It asserts

that health care quality is the degree to which health care

improves outcomes and maintain consistency with current

knowledge of practice. Obstacles to achieving this goal were

outlined as unnecessary/inappropriate care, underuse of effec-

tive/appropriate care, and shortcomings in technical or person-

nel in care. 10

This was followed by the Institute of Medicine’s

initiative proposing a coordinated effort to further exam quality

improvement issues, devise measurements of quality improve-

ment issues, all while paying special attention to vulnerable

populations that do not traditionally receive the same quality

of care as others in the United States.

While this launched a coordinated effort, it was not until the

1999 report To Err Is Human that the quality improvement

initiative gained public traction. 11

Reporting that nearly as high

as 100 000 preventable deaths per year occur during health care

delivery due to medical errors. The leading causes of the death

were medication and communication errors. This report out-

lined the need for improvement in medical electronic informa-

tion systems and reporting of medical errors. The medical

electronic information system remained far less developed than

in other disciplines such as banking or the airline industry. In

addition, liability without protection for health care workers

inhibited error reporting and resulting improvements. 11

This

spurred public awareness and catalyzed the Agency for Health-

care Research and Quality (AHRQ) to perform a review on

quality assessment and improvement in US health care.

As this investigation was launched, there was an additional

publication by the Institute of Medicine in 2001, Crossing the

Quality Chasm, further demonstrated the discrepancy between

the recommended delivery of health care and the reality of

American health care in its current form. It described the fac-

tors that delivered inconsistent health care across the country

regardless of insurance status, race, gender, geographic loca-

tion of the patient. The Institute of Medicine report illustrated

that medical information has irregular distribution secondary to

poor information systems and lagging use of current technol-

ogy. This prevents scientific advances from becoming uni-

formly available to practitioners across the country. From

this discrepancy, new clinical education centered on increased

interdisciplinary cooperation identified specific aims as drivers

of health care change. These drivers were safety, efficacy,

patient-centered care, timely, efficient, and equitable. 12

Over-

all, the report emphasized use of new technologies to deliver

safer, more efficacious, and cost-effective care without finan-

cially penalizing individuals streamlining the care.

Since these publications defining the future direction of

quality improvement, the Institute of Medicine has worked

through three platforms: environmental, health care organiza-

tion, and the interface between physicians and patients. Such

efforts include redesigning primary care and care for patients

with chronic conditions, restructuring insurance coverage and

Figure 2. Avedis Donabedian’s standards for evaluation the quality of health care.

Hines et al 7S

The difficulty in the past was how to measure these goals. To accomplish this, he described three types of metrics for evaluating quality in health care: structure, process, and out- come (Figure 2). Structure includes credentialing of providers, adequacy of facilities, and administrative systems delivering care. Process observes which components of care are delivered and their appropriateness and competency of delivery. He recognized that it is rarely the individual that creates the problem but rather the process is a fault and needs to be changed for better results. Outcome involves evaluation of recovery, restoration of function, and survival. Measuring outcomes is necessary to determine what interventions are effective and should be implemented. Within these standards, he emphasized the need for clear presentation of these metrics (dashboards and scorecards) and broad quality measurements, including prevention, recovery, continuity of care, societal and cultural values, and economic efficiency. This way physicians can begin to truly understand evidence surrounding a problem and recognize issues affecting health care quality. This also provided the framework on which the interest in patient individualized out- comes and value-based care was developed. See endnote 8 on page 5.

malpractice in Fostering Rapid Advances in Health Care:

Learning form System Demonstrations. 13

Another agenda laid

forth ideas for educational reform, including establishment of

core competencies, public reporting, and fostering training

environments and oversight. 14

It was also during this time that

the Institute of Medicine emphasized institution of electronic

health record systems with national standards for collection of

this data. 15,16

Finally, the Institute of Medicine outlined com-

mon and costly medication errors as well as a comprehensive

approach to minimizing these errors in the report Preventing

Medication Errors. 17

Since its founding, the Institute of Medicine has changed its

name to The National Academy of Medicine (http://www.natio

nalacademies.org/hmd/). It has been instrumental in launching

a quality improvement initiative consisting of 3 phases.

Already, in the first 2 phases, the Institute of Medicine has

outlined and highlighted the discrepancy between current and

ideal delivery of health care, made proposals on how to trans-

form the health care system to close this gap. The final phase of

this quality improvement initiative focuses on ongoing efforts

to execute this transformation and the proposed mechanisms

for quality improvement.

Understanding this history is vital for spine surgeons mov-

ing forward. Spine surgery has not been immune to the health

care quality initiative. The quality improvement movement

will define the future trajectory of major specialties such as

spine surgery. All the concepts defined in the past century such

as outcome-based care, standardization, and resource effi-

ciency will guide future policy. Health systems are moving

away from the fee for service model and pushing for a more

sustainable system. This system is grounded in population

health and preventative medicine, value-based care, and new

payment models. 18

Traditionally, the surgical management of

patients with spinal disorders represented a very heterogeneous

population with varied outcomes. Variability can be defined as

both expected variation as well as unexpected variation. 19

This

unexplained variation can lead to excess waste and costs. Costs

associated with surgical intervention may be very high and

outcomes are poorly characterized. This is may be due to the

homogenization of techniques that evidence-based medicine

encourages. As prospective trials and studies with high levels

of evidence require rigid inclusion/exclusion criteria with con-

trol of confounding variables, large studies quickly lose their

generalizability. This makes higher level evidence costly and

difficult to apply to patients with spinal disorders. This is an

example of the Institute of Medicine’s described discrepancy

between current and ideal delivery of health care.

As such, there is opportunity for quality improvement as

cost, efficacy, safety, and patient centered outcomes have yet

to be fully defined for many treatment paradigms in existence.

To address this deficiency, spine registries have gained popu-

larity in parallel with growing emphasis on health care quality

improvement. With a foundation laid upon Ernest Codman’s

work in “end result theory,” registries represent a more scal-

able, cost-effective, alternative to randomized clinical control

trials evaluating outcomes in a more generalizable context.

The first major registry established was the National Spinal

Cord Injury Database. Started in 1973, the database was orig-

inally part of a project mean to demonstrate superiority of

comprehensive spinal cord injury care over fragmented care

across different centers. 20

As multiple centers joined the proj-

ect, large volumes of data were generated for analysis. In the

first 10 years alone, the National Spinal Cord Injury Statistical

Center spurred advancements in spinal cord injury care in

emergency, acute care, and rehabilitation settings. Rare for the

time period, prospective data was collected on patient demo-

graphics, pathology, procedures, complications, implants, and

patient-reported outcomes. Being one of the longer maintained

databases, it has served as an example on the data that can be

generated from years of follow-up on a variety of spinal pathol-

ogy. Since then, many major registries have been established

with ongoing enrollment since then. Such registries include the

Swedish Spine Registry, Spine Tango, Rick Hansen SCI,

N 2 QOD, British Spine, AOSpine, Kaiser Permanente, Vander-

bilt Prospective Spine, North America Clinical Trials Network

(NACTN), NASS and include various pathologies such as

trauma, degenerative lumbar disease, and deformity among

other conditions. 21,22

As the scope of a registry gets larger, the

follow-up tends to be shorter as the infrastructure required to

maintain the database increases. As such, along with the Swed-

ish Spine register, N 2 QOD (renamed as the QOD, Quality Out-

comes Database) is a multicenter registry collecting

prospective patient-reported outcomes with 12-month follow-

up rates exceeding 75%. As these databases accumulate data, it is becoming apparent that while spinal surgery generally has

low rates of morbidity and high rates of sustained treatment

effects. However, there is a large degree of heterogeneity and

significant variation in treatments as well as individual’s

response to treatment from patient to patient. It is important

to note that there are wide variations in the design and data

accumulated. Registries may have prospective versus retro-

spective designs, variability in follow-up and sample sizes, and

different metrics used to evaluate outcomes. All of this must be

weighed carefully as different clinical conclusions may be

drawn from different data sets. However, understanding this

will allow physicians to identify registries that best suit the

population they serve when using them to enforce clinical

decisions. These registries will become extremely important

in improving quality care by identifying which cohorts of

patients will or will not benefit from a particular surgery. Using

data from a registry like QOD, a surgeon will be able to create a

personalized predictive calculator for an individual patient’s

response to therapy. 23

As Donabedian noted late in his career, “There’s lip service

to quality and, goodness knows, propaganda, but real commit-

ment is in short supply.” 24

As clinical registry databases con-

tinue to grow, and the information technology platforms on

which they are based improve, their predictive modeling cap-

abilities and comparative power will continue to accumulate

and drive quality improvement in medicine forward. They will

provide invaluable data on comparative efficacy of various

surgical and nonsurgical treatments for spinal disease.

8S Global Spine Journal 10(1S)

Since its founding, the Institute of Medicine has changed its name to The National Academy ofMedicine (http://www.natio nalacademies.org/hmd/). It has been instrumental in launching a quality improvement initiative consisting of 3 phases. Already, in the first 2 phases, the Institute of Medicine has outlined and highlighted the discrepancy between current and ideal delivery of health care, made proposals on how to trans- form the health care system to close this gap. The final phase of this quality improvement initiative focuses on ongoing efforts to execute this transformation and the proposed mechanisms for quality improvement.

Understanding this history is vital for spine surgeons moving forward. Spine surgery has not been immune to the health care quality initiative. The quality improvement movement will define the future trajectory of major specialties such as spine surgery. All the concepts defined in the past century such as outcome-based care, standardization, and resource efficiency will guide future policy. Health systems are moving away from the fee for service model and pushing for a more sustainable system. This system is grounded in population health and preventative medicine, value-based care, and new payment models. See endnote 18 on page 5. Traditionally, the surgical management of patients with spinal disorders represented a very heterogeneous population with varied outcomes. Variability can be defined as both expected variation as well as unexpected variation. See endnote 19 on page 5. This unexplained variation can lead to excess waste and costs. Costs associated with surgical intervention may be very high and outcomes are poorly characterized. This is may be due to the homogenization of techniques that evidence-based medicine encourages. As prospective trials and studies with high levels of evidence require rigid inclusion/exclusion criteria with control of confounding variables, large studies quickly lose their generalizability. This makes higher level evidence costly and difficult to apply to patients with spinal disorders. This is an example of the Institute of Medicine�s described discrepancy between current and ideal delivery of health care.

The development of these quality improvement efforts will also

improve the systems of care to patients at the local level. These

registries represent invaluable adjuncts to randomized clinical

trials that will evaluate rapidly changing heterogeneous popu-

lations and practices. 25

Using these tools, treatment paradigms

may be altered so that the quality of spinal care delivered may

be more efficacious, cost-effective, safe, and patient centered.

As the history of quality improvement in recent years has

shown, value-based and outcome-driven policy is becoming

more important in every field, including spinal surgery. The

future of spine surgery is interwoven with these quality

improvement developments as the field searches for ways to

improve the outcomes of these heterogeneous, complex

patients.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to

the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for

the research, authorship, and/or publication of this article: This sup-

plement was supported by funding from AO Spine North America.

ORCID iD

Kevin Hines, MD https://orcid.org/0000-0003-1700-174X

Nikolaos Mouchtouris, MD https://orcid.org/0000-0001-9495-93

91

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Declaration of Conflicting Interests

Funding

ORCID iD Kevin Hines, MD https://orcid.org/0000-0003-1700-174X Nikolaos Mouchtouris, MD https://orcid.org/0000-0001-9495-93 91

References