The doctor defined: The paperwork behind patient safety

Andrew Whittamore: “Without a thorough credentialing process, you don’t have a clue who the people are who are applying to work in your hospital.”

What does a doctor look like? Is he male? Does he wear a white coat, or have a stethoscope draped around his neck? When he speaks, do the younger doctors in the hospital pay close attention? When he talks about a certain disease or suggests options for treatment, does the tone of his voice and his ease with the jargon convey his authority and grasp of the subject? If he looks like a doctor, sounds like a doctor, and behaves like a doctor, why would anyone question him? After all, isn’t the field of medicine the province of noble servants, and the provision of health care, at its core, a charitable good?

For many of us, the idea of the “doctor” is an archetype that is deeply ingrained in our cultural understanding. He is instantly recognizable in our old movies as the man carrying a black bag which is presumed to hold the tools of his trade. The image of the black bag may be a relic today, but we have replaced it with other associations, like the white coat, the stethoscope, or the office wall covered with diplomas and certificates. As patients, we enter the health care system looking for someone to give our trust—placing ourselves under the authority of another, of a trained professional, is part of how we reassure ourselves that we if we are sick, then we can be made well. Thus it is possible for us to proceed through our encounters with the health care system without experiencing a single doubt as to the qualifications of the person treating us, advising us, and prescribing our medication. For this privilege—and for the peace of mind it gives us—we can pay dearly.

In the United States, the dual processes of credentialing and privileging physicians have been established to protect patients from unqualified health care providers, with the broad objective of reducing medical error and achieving the highest possible standards of health care quality. This is a laudable goal, and certainly in line with the Hippocratic Oath, which describes, in part, a “covenant” between the doctor and patient that the physician will not do injustice to the patient. However, credentialing and privileging gained their foothold in the American health care system through the legal system. Forty years ago the Supreme Court of Illinois set an important precedent when it ruled that hospitals were liable for the actions of individual health care providers acting within. Since then, health care providers have developed the policies and procedures to protect themselves from liability. That these processes at their core impact patient safety is a most valuable side effect.

In this issue of HMI World, we take a look at these important processes—with a particular emphasis on credentialing—and explain not only how they are carried out, but what obstacles might prevent health care providers from putting them in place. While this article approaches the subject through the development of credentialing and privileging processes in the U.S., there is no doubt that this issue resonates with health care providers all over the world. For hospitals striving for regional leadership, concerns about patient safety, risk management, and medical error reduction are closely tied to competitiveness.

First, it is important to understand that credentialing and privileging are two distinct processes. Credentialing is the process of obtaining, verifying, and accessing the qualifications of a health care provider to provide patient care services. It is based on four criteria: current licensure; relevant education, training, and experience; current competence; and current clinical competence and ability to perform requested privileges. The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) defines credentialing very explicitly as the “series of activities designed to collect relevant data that will serve as the basis for decisions regarding appointments and reappointments to the medical staff, as well as delineation or clinical privileges for individual members of the medical staff.” This latter definition is important because it emphasizes the outcome of the credentialing process: a decision. For prospective employees, the process determines their admittance into the organization (or their rejection); for existing employees, the process serves to reassess the individual’s fitness to continue practicing in the institution.

If credentialing is to be understood, then, as the process which grants one membership in the medical staff (that is, who is admitted into the hospital or other setting and is allowed to represent the institution by wearing the aforementioned white coat), then privileging, the next step, grants a practitioner permission to provide medical care services within defined limits, and allows the health care professional to practice what he or she has been trained to do (that is, what happens once they have been permitted inside).

Supporting a culture of quality
Traditionally in the United States, there was no institutional liability for the negligence of individual providers. However, the decision of the 1965 case Darling v. Charleston Community Memorial Hospital resulted in various state courts recognizing a new doctrine called “hospital corporate liability.”

Assumptions versus reality: The credentialing process goes beyond what we think a doctor should look like, and helps health care organizations make sure that they have the facts about the people practicing medicine in their hospitals and clinics.

The Darling case concerned a teenage boy who was taken to Charleston Community Memorial Hospital for treatment of a fractured leg. His leg was placed in a cast, but then he suffered from gangrene, and had to have his leg amputated below the knee. The boy’s father sued not only the physician, but also the hospital. The hospital countered that it did not practice medicine and thus could not be found negligent. However, the plaintiff claimed—and the court agreed—that the hospital was negligent for two reasons: it failed to properly review the work of an independent doctor, and its nurses failed to administer necessary tests. The case held that the hospital by-laws, licensing regulations, and standards for hospital accreditation were sufficient evidence to establish the standard of care. Therefore, the jury was able to conclude from the evidence that the hospital had breached its duty to act as a reasonably careful hospital. This case established hospitals’ corporate liability for the quality of the medical staff.

Since then, the process of evaluating the quality of medical professionals— and formally credentialing them—has been further developed and formalized. The concept itself includes policy development, the decision-making hierarchy, required documentation, application and attestations, external information sources, and site visits. Andrew Whittamore, MD, the chief medical officer at Brigham and Women’s Hospital (BWH) in Boston, oversees credentialing at his hospital, and makes no effort to minimize its breadth or complexity. “This is a very thorough, time-consuming process,” he says. “Health care organizations need this process to ensure that they are providing a certain standard of quality of care. Although the medical degree carries with it a certain respect, the trust has been breached. Without a thorough credentialing process, you don’t have a clue who the people are who are applying to work in your hospital.”

The process as it exists today at BWH (see sidebar) has been in place for about five years, but the basic structure has been around for 25 years, changing over time due to external or regulatory factors. Currently BWH has about 1,800 full-time clinicians, and an additional 1,200 to 1,500 investigators with part-time clinical obligations who are required to go through this process once every two years, regardless of how long they have been on staff or how highly regarded they are in their field. “Sometimes the process moves faster, but I would estimate that credentialing takes an average of about three months,” says Whittamore.

It is important to note that hospital credentialing processes are conducted by clinicians and hospital boards, not administrators. The final decision-makers are generally the hospital’s medical director, a committee that includes peers, and the management or board of directors of the provider.

Several steps can be taken to reduce the risk of liability associated with credentialing. First and foremost, developing a risk management plan that addresses qualifications, credentials, and practice guidelines should eliminate a substantial degree of inconsistency and minimize liability. In addition, facilities must institute and maintain written protocols that provide systematic guidance to administrators, surveyors, physicians, and other entities and individuals who are entrusted with credentialing functions. Here consistency is crucial—a facility’s governance documents, such as bylaws, rules and regulations, policies, procedures, and protocols should be the same for every physician who undertakes the process. Too often, whether driven by market competition or other factors, decision-makers fail to take necessary actions in accordance with their facility’s written protocols or make exceptions for practitioners who are well respected in the community or who have been with the hospital staff for many years.

John Helfrick: “Privileging is one of the last major obstacles for many hospitals, even progressive institutions with strong medical leadership.”

Credentialing is a commitment
Around the world, the growth of the health care industry has helped to drive quality improvement efforts at major health care providers. Medical directors are embracing the concept of patient safety and developing the infrastructure to measure and support continuous improvement. Yet the idea of credentialing physicians—of mitigating risk and ensuring quality at the entry point of the hospital—lags behind. “This is a major deficiency in hospitals internationally,” says Dr. John Helfrick, who consults with health care providers around the world to help them prepare to meet the standards for health care quality established by Joint Commission International (JCI is the international division of Joint Commission Resources, the subsidiary of the JCAHO.).

One explanation for the lack of credentialing is a lack of resources—it is not uncommon for hospitals to have expert medical staff, but lack many valuable elements of health care infrastructure, such as departments focused on budgeting, supply inventory, and other necessary functions. As Whittamore points out, BWH has dedicated staff for the credentialing process.

However, the biggest obstacle to credentialing may be the physicians themselves, and the entrenched systems that have held them in unquestionable esteem for many years. “The major hurdle, from my perspective, is the traditional hierarchical independency of physicians around the world,” says Helfrick. “In general, they don’t want to be measured, questioned, or limited when it comes to their care of patients.”

To gain the support of their physicians and staff, it is important that hospital leaders make the purpose of the process clear. “It is very threatening to physicians until they understand that it is a rational way to assure that the practitioners that are treating patients and performing procedures are competent to do so,” said Helfrick. “There is, however, a growing acceptance by those health care providers who are able to practice independently, to accept some sort of oversight and privileging. But it’s a slow process and generally requires a third party to institute the process, like a government mandate or an accreditation process.”

Privileging guides practice
Privileging, a separate piece of patient safety, is the process of establishing and verifying expertise and proficiency within a specific area of medicine. A privileged provider is one who initiates, monitors, or can stop a course of treatment.

The Gonzales v. Nork decision is a landmark in the development of privileging. In 1967 a young man named Gonzales was injured in an automobile accident. The physician, Nork, performed a laminectomy—the indication for which was questionable—that resulted in complications. Gonzales sued both Nork and the hospital where the procedure had been performed. During the trial the plaintiff presented evidence that over the course of the previous nine years, Nork had performed 36 unnecessary or injurious laminectomies. Thus in 1973 the Supreme Court of California ruled that the hospital should have been aware of the doctor’s substandard practice and taken steps to protect other patients.

The concept of privileging dates back to the early 1900s, when Ernest Codman, MD, chief of surgery at Massachusetts General Hospital (MGH) in Boston, wanted to look at the “end results” of care provided at MGH, particularly that of the surgeons. Codman’s idea was to use performance to define the scope of the doctors’ privileges. This provoked outrage from his peer practitioners, but led later to the formation of the American College of Surgeons Hospital Standardization Program, which ultimately became JHACO. (Codman’s work anticipated contemporary approaches to quality monitoring and assurance, establishing accountability, and allocating and managing resources efficiently, among other assessment features.)

Privileging is performed by the head of a given department. In the hospital setting, it refers to permission to perform a set number of diagnostic and therapeutic procedures commensurate with education and training. The purpose of the process is twofold: to prevent physicians from performing procedures outside the purview of their expertise, and to prevent physicians from performing procedures that exceed the facility’s financial and personnel resources.

Privileging, says Helfrick, is “still one of the last major obstacles for many hospitals, even progressive institutions with strong medical leadership.”

Safety in numbers
Whittamore says that although these processes are time-consuming and require an increase in personnel (as does malpractice), they should be an easy sell. “If you can assure your Board of Directors and your stockholders that you are providing care of a high quality, then that is a very significant motivator. It only takes one or two bad apples to harm the hospital’s reputation.”

Bad apples, indeed. Consider the bizarre case of a fugitive from Canadian justice who made his way down to Florida. Masquerading as a deceased Italian physician, he was able to secure a medical license, obtain hospital staff credentials, and even became the hospital’s medical director. While this incident led to an important Supreme Court decision regarding the responsibility of hospitals to select and retain competent physicians, one might imagine the headlines that such an incident would generate, and the impact they would have on the hospital.