Spotlight Interview: Sharon Kleefield, Ph.D., Healthcare Standards Institute

About Sharon Kleefield, Ph.D.

Retired faculty, Harvard Medical School (HMS), and former Director of Healthcare Quality at Harvard Medical International. Her work has focused on developing and deploying standards in healthcare. Her expertise includes Health Care Management Education and Training programs for clinical staff both at HMS and globally. Prior to HMS, Dr. Kleefield served on the faculty of the Harvard Business School. Additionally, Sharon was the Director of Clinical Quality Initiatives Program for 9 years at the Brigham and Women’s Hospital, a 780-bed Harvard affiliated tertiary care teaching hospital. Dr. Kleefield has provided education and training in quality management, performance measurement, safety and accreditation standards preparation to health care systems and hospitals in 15 countries. Learn more on LinkedIn.

About Healthcare Standards Institute

At Healthcare Standards Institute, the mission is to improve the health and wellbeing of individuals through the development and advancement of American National Standards and educational resources for healthcare organization management. HSI strengthens the systems and organizations that deliver care so that they are resilient and competitive in the global marketplace. Our vision is to create leading sustainable improvement in healthcare organization management. Visit hsi.health/.


Medical Travel and Digital Health News (MTDHN): Tell us how you got involved and became the Editor in Chief of the Journal of Healthcare Management Standards (JHMS).

Sharon Kleefield (SK): I have spent most of my career in healthcare quality, healthcare management and designing systems in healthcare organizations. Dr. Veronica Edwards, who is the CEO of the Healthcare Standards Institute contacted me to see if I would be interested in taking on the editor in chief position of this new, peer reviewed journal focused on standards, quality and healthcare management, given my experience as the former Director of Healthcare Quality at Harvard Medical International.

This journal will be issued bi-annually. The first issue is now out and the second issue is expected in February 2022. Anybody is invited to submit a manuscript and there is no fee for publication.

MTDHN: What do you envision for this journal? What impact would you like it to have?

SK: It is a response to what the Healthcare Standards Institute sees as a chance to provide innovative, timely and groundbreaking ideas in healthcare management. This would come from a very diverse international and collaborative approach.

The goal we have in mind is for the journal to be a response, not only to the current COVID-19 pandemic, but also to gaps that we see within the healthcare system, both in the U.S. and worldwide.

We want this to be a chance to provide and develop definitive American national standards and educational resources for healthcare organization management that will support continuity of care and improved patient outcomes.

MTDHN: Where will it be distributed? Are there any specific channels?

SK: The journal will be distributed widely to healthcare organizations, healthcare management programs, universities and certainly to many of us who are working on expanding and furthering standards that relate to healthcare management.

We feel that that’s an area that can be developed further and we’ll include a variety of experts from the U.S. and around the globe. We have an international editorial board from 12 countries, which will provide expertise and diversity to those organizations and providers in adding value to management of healthcare organizations.

The journal will provide academic papers, position papers, editorials and reviews that address diverse healthcare performance and quality issues.

MTDHN: Can you tell the readers about any specific topics in upcoming issues?

SK: Yes, anticipated topics in the journal include:

  • best practices in healthcare
  • organization management
  • reliability standards in bio engineering
  • capital slash financial management
  • electronic health records and reporting,
  • hand hygiene
  • supply chain planning and oversight
  • pandemic response
  • management risk management through adaptation of established standards
    and review
  • healthcare workforce training, empowerment and satisfaction
  • standardization in digital and e-health
  • telemedicine.

The idea is that the journal will serve as an open forum for manuscript submissions that will address diverse healthcare performance and quality issues. It will also serve as an avenue for constructive commentary and invited dialogue to accelerate the implementation and enhancement of the complex healthcare delivery system.

MTDHN: Are there other journals out there that have attempted to do this?

SK: There are many healthcare journals that address accreditation, aggressive clinical standards, risk management, overall quality of care issues, but this particular journal is unique in that it will add to the existing journals in quality of care and standards, but it’s primarily focused on health care management standards with the idea that the development and application of these standards will improve quality of patient care.

MTDHN: Can you tell the readers about your career?

SK: I have been very fortunate in my career development over many years. I began my academic work and interests in the field of medical ethics when I finished a Ph.D. at Boston University in the department of philosophy with a specialty in medical ethics.

My goal at that time was to be an educator at the university level and develop the whole field of medical ethics. At that time, philosophers were just beginning to be involved in issues of medical ethics. I was able to teach for a few years, write some case studies and be involved in the development of that field. Then I took a left turn and accepted a position at the Brigham and Women’s Hospital, which is an 800-bed tertiary care hospital affiliated with Harvard Medical School.

In that position around 1992, I was asked by the one of the vice presidents of the hospital to develop an approach to improving efficiency and quality throughout the hospital. It was very early in the development of quality and systems thinking in healthcare.

I was my own startup. I developed a training program and worked across clinical domains at the Brigham and Women’s Hospital for nearly 10 years. In that position, I worked with physicians, medical students and other faculty, and we worked with many of the chiefs of departments, physicians and nurses.

It was a great experience. It was sort of on the job learning while also publishing teaching case studies and developing others who can apply this in their healthcare organizations. I did some early work with the Institute of Healthcare Improvement.

Finally in the last chapters of my career, I was asked to become faculty member of Harvard Medical School and to work on international projects specifically utilizing my background in quality management training, outcomes management and systems development.

That opportunity was almost 15 years of a great experience working in 15 different countries where the systems are quite different. This was a great learning experience for me because every time I worked in a different country in a different healthcare system, it taught me more about the issues and what to think about in education and training.

I remained involved particularly with the Indian health care system. I still provide education and training across the country in medical schools in India. Many of the people I worked with have agreed to participate as members of the editorial board of this journal.

I’ve always focused on education and training and working with people to learn how other systems, not just the United States accomplish improved quality of care. That’s what it’s all about, improving the quality of patient care.

I have been circling the world of standards for most of my career, but this now takes me into another chapter if you will.

MTDHN: Tell me about quality of care and standardization of benchmarking. Do you find that other countries are ahead, on par or behind the United States? Where do we stand in the world?

SK: I would say over the last 15 years of my involvement around the world, healthcare systems are incorporating their own standards based on what has been published and what has been shown to be effective approaches and measurement standards to improve efficiency and quality.

When I started in the industry, many of the countries where I was involved over a long period of time were learning, and so many countries now have their own quality standards. The world of quality standards now has been developing quite earnestly over the last 15 to 20 years.

Because the U.S. is so regulated, every healthcare organization hospital has to be accredited by the local public health agency, but also by the joint commission. The U.S. has been forced to adhere to a very robust system of standards because the government has told them that if they want to get reimbursed for their care or their services to patients, they have to meet these standards.

Every three years, there’s an onsite, very intense review of the organization and the application of these standards. The U.S. has faced meeting standards for many years.

However, that is not a guarantee on quality, because quality involves ongoing leadership training measurement. Other countries, even in the developing world, have certainly learned from other countries and are now pushing for their own system of standards and training for improvement.

I would say that the U.S. certainly is an early entry to the world of standards, but the world has been very active—particularly hospitals—in many countries in trying and applying international studies and learning to their own or organization to their own culture so that they can continuously improve in-patient care, and certainly to improve the management of their staff in adhering to standardization.

Accreditation is a baseline for patients feeling comfortable in assessing where they might seek care, whether it’s by the local organization in a country, or by an international set of standards.

This baseline is the ‘floor’ for quality, but not the ceiling. There are many other elements to assessing being comfortable, such as the training and background of the clinical staff and some measurement of their volume and their outcomes related to the specific care that the patient is seeking.

Certainly with a global pandemic, one must be careful in assessing the destination in terms of the local management systems in place to prevent and manage infectious diseases. Focusing on known evidence-based metrics of risk management and adverse events are in addition to accreditation.

A clear view of Universal Precautions and their application to care is an important quality metric. The patients’ voice and concerns are also important to good care, including specific standards for consent to treatment, including possible risks and benefits described by the clinical management. Studies have shown that communication protocols across the care team, and communication with the patient/family, are markers for reducing risks and maintaining good quality.

We don’t have a lot of data when comparing one system or one healthcare facility with another. Even in the US this can be difficult to assess. One has to be clear on the criteria that would be applicable not only in the U.S., but also internationally, that are very basic to providing excellent quality of care.

MTDHN: Do you think that U.S. Medicare should cover the cost of care outside the United States as a way to not only ensure quality, but to save money possibly?

SK: One example that comes to mind is if you look at a large company like Walmart. Walmart employees can choose, and in some cases, are encouraged strongly to get care in places outside of the local community.

It may be less expensive. Walmart claims that in many cases patients are receiving unnecessary radiological imaging that is costly to the company. Again, the need for standard protocols and clear indications for ordering imaging is thought to be the aim of part of the company’s excellence program.

Gathering and managing such data sounds simpler than it is. Local medical cultures have been shown to have many variations in when and what imaging is most appropriate. Collecting data and maintaining transparency will continue to be important for Medicare coverage and payment schemes. This is an ongoing challenge for sure.

To cover the cost of care outside the U S, Medicare should ask for specific standards-of-care metrics that would ensure that the patient will receive acceptable quality of care and be safe. It’s quite doable and competition for patients abroad has been increasing until the pandemic hit us globally.

It will take some time going forward, however, my direct experience with several facilities abroad has shown me that competition and risk management is a driver for continuous quality improvement.

I am optimistic that global care is improving and that we continue to learn from each other. Cost savings remain appealing to seniors if it is balanced by quality and safety. Creating a global network of quality data is a dream of mine, but it has yet to be actualized, but I am hopeful.

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