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From the moment a patient walks in the door, Tobias Neuhann MD, and his employees at the EyeCare Institute in Munich, Germany know their responsibilities.
Such responsibilities may seem obvious, but it was only after steering the clinic through an intensive quality certification process that Dr Neuhann realised how such assumptions depend on a management system based on strict standards that must be drawn up, enforced, reviewed, and updated.

“And now we have a certificate that says patients can expect a certain standard when they come into the clinic,” says Dr Neuhann, whose clinic was the first private eye clinic in Germany to receive a certificate for quality management.
Although the concept of certifying a clinic may seem foreign to many ophthalmologists, Dr Neuhann and increasing numbers of his colleagues know that politicians, regulators, insurers, and patients throughout Europe will soon be looking to certification as an independent means to judge the quality and efficiency of medical care.

With the certification, the clinic is recognized for the quality of its management standards, standards that meet the minimum requirements set down by the Geneva-based International Organisation for Standardisation. The clinic’s certificate recognizes that Dr. Neuhann’s clinic has in place those procedures, protocols and guidelines that the ISO consider necessary to ensure a quality service. In many ways the ISO designation — of ISO 9001 — is to a clinic what the CE mark is to a medical device manufacturer.
“Certification is something that the patient can understand and something the physician can understand,” Dr Neuhann says.

To earn the ISO 9001, Dr. Neuhann had to demonstrate the clinic’s commitment to eight principles in its management system:
1. focusing on the patient;
2. establishing leaders;
3. involving employees;
4. developing a process of work;
5. developing a process of managing that the system of work;
6. improving the clinic’s performance;
7. making management decision based on facts;
8. developing beneficial relationships with the clinic's suppliers.

There are limits to the certification process, however, Dr Neuhann acknowledges. For one, the certification process does not judge his clinical competence. And while that limit may mean that certification may not be a perfect way of judging the clinical quality of a medical practice, it’s about the best there is.
“As long as we do not have a uniform standard, it is the only way to show that you keep up quality in the office,” he says. “It’s no guarantee, but it the best we can do at the moment.”

Despite such limitations, the certification process helps create an environment that promotes clinical competence, he notes.
For example, when a patient comes in for surgery, the written protocol includes the type of drops the patient should receive and who should give them.

“That means that if you may have a new employee who doesn’t know what to do, she can learn what to do by taking out our handbook and reading what she needs to know and giving the patient the drops,” he says. “It’s all about documentation, so that everything is done in the same way every time.”

“And each step of what you do as an ophthalmologist with a patient will be documented, too,” he adds. “And if you add something new, that too, must have a new standard.

Guidelines also mean that duties are clearly delineated, thus eliminating many potential clashes between staff members. “Each person has a specific responsibility for an area that he or she can look over,” he says. “That way, if you find something that is not running well, you know who to speak to.”

To help keep the clinic running well, Dr Neuhann periodically invites Frank Tillmann, a management consultant, to visit. Mr Tillmann who helped steer the clinic through the initial certification process in 1999 and the re-certification process earlier this year, says many physicians could benefit from certification to improve the quality of the service they deliver — and perhaps make more money, too.
“In most companies, the boss is a professional in his own specific area,” he says. “Doctors, too, are professionals in practicing medicine, but they are not professionals in leading employees or in making money.”

Mr Tillmann insists, however, that he doesn’t tell Dr Neuhann or any other physician how to practice medicine but rather how to analyze, monitor, and review the medical service that he provides.

“It is very important that I am not a doctor,” he says. “I never discuss ophthalmology. What I discuss are measurable gains and services.
Successful measurement of those gains and services depends on a three-step process, he says.

The first step involves an analysis of the internal organization of the clinic and the documentation of every step in the treatment process. The second step involves the creation of a management strategy based on goals and internal audits to monitor the quality of the clinic management systems and processes. The third step involves the creation of a process to review outcomes that can identify poor practice and correct it.
Mr Tillmann notes that the certification process not only satisfies physicians and staff. It also helps satisfy patients. For instance, since the clinic began the certification process, it has reduced waiting times from about one hour to 14 to 16 minutes.
Despite the advantages of the certification process, it isn’t cheap, at €20,000 to €30,000, depending on the size of the clinic.

Mr Tillmann adds that certification isn’t for every physician practice. “If you use certification to design a quality management system or to make your clinical practice more effective, then the way of certification is right,” he says. “But if you only want to get a certificate, certification is not the way to go.”
Back at the EyeCare Institute, Dr Neuhann recalls that the certification process taught him a valuable lesson: that no physician alone can ensure the quality of medicine.

“You can say I can do it myself , but you can’t do it,” he says. “With the certification process, you begin to realize that it is not the doctor who can do everything. Instead, you must get more and more staff members responsible for certain steps in the treatment process.”

Because those staff members receive more responsibility, they will be encouraged to use the certification guidelines and protocols to help the ophthalmologist monitor and review clinical outcomes. “That way, the wrong results can be detected immediately and corrected immediately,” Dr Neuhann says.
And, he adds, everyone benefits: physicians, employees, and, of course, patients.

Ophthalmologists also turning to accreditation
Jorge L. Alio, MD, PhD, knows the work — and rewards — of accreditation first hand. The clinic of which he serves as medical director, Instituto Oftalmoligico de Alicante, is the only eye clinic in Europe to be accredited by the prestigious Joint Commission International.

As the clinic’s medical, director, Dr. Alio devoted up to 20% of his time preparing the clinic for accreditation, which culminated in 1999 with an extensive on-site inspection of the institute by a team of surveyors from the United States.
Although there is no legal requirement in Spain to be accredited, Dr Alio says he was drawn to accreditation for its high aspirations. “It is an external high quality controlled overview that implicates all the organisation with the ultimate goal of quality in healthcare,” he says.

Although new to Europe, accreditation is a key requirement in the United States, where state governments and health insurance companies require accreditation as an independent verification of the quality of a health care institution. The parent body of Joint Commission International, the Joint Commission on Accreditation of Healthcare Organisations, accredits more than 90% of hospitals in the United States.
Dr Alio adds that the Institute also has an ISO 9001 certificate for quality management.

The accreditation process, however, was much more difficult and involved than the certification process, he adds.

One of the prime reasons for the differences is that accreditation — unlike certification — involves an appraisal of the clinic side of the health care institution and its physicians. Also accreditation includes an intensive three-day visit by a three-member team composed of a physician, nurse, and hospital administrator.
Despite the commitment of time and resources, Europe is not shying away from accreditation, according to Paul van Ostenberg, DDS, the executive director of International Accreditation at Joint Commission International.

At least three European countries — France Germany and Ireland — are planning to introduce accreditation programs for their hospitals, Dr van Ostenberg says. Also, the World Health Organisation and World Bank have backed accreditation as a way to ensure that money is well spent on hospitals in developing countries.
“Studies show that accredited hospitals are well managed, have fewer repeat procedures, and experience fewer lawsuits,” Dr vanOstenberg says.

Accreditation doesn’t come cheap however. The average Joint Commission survey costs $21,000 and usually entails months of preparation and paperwork before the Joint Commission’s survey team arrive on site to review the hospital's clinical and non-clinical standards.

Despite the price and work, Dr Alio gives accreditation the thumbs up.
“It changed the organisation in many respects”, he says, adding that he would recommend accreditation for any clinic “that pursues a high profile of professional work”.

If you would like to read previous "Regulatory Matters" columns, check out the archive.

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