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Countering reports regarding negligence, mistakes and malpractice in today's medical industry, one small practice has taken steps to ensure that these catastrophes don't happen there. In 1995, the Cleveland Center for Joint Reconstruction pursued and received ISO 9001 registration, and has reaped nothing but benefits ever since. CCJR became the first health care practice in the United States to receive this registration.
Since becoming ISO 9001-registered, CCJR has experienced lower costs, and more control and consistency in the care it provides. The center attributes much of its success, as well as the continuing satisfaction of patients and employees, to its ISO 9001 registration. The registration attests that CCJR's quality management system ensures that the practice provides more reliable and accurate service, more comprehensive patient care and follow-up, and a thorough records management system.
As the center discovered, ISO 9000 can benefit a wide range of companies, no matter what their size, in many different industries. CCJR is an orthopedic practice specializing in treating arthritic hips, knees, ankles, feet, shoulders, elbows, wrists and hands. The practice was founded in 1992 by two internationally recognized orthopedic surgeons, Bernard N. Stulberg, M.D., and Alan H. Wilde, M.D. CCJR today brings in $2 million annually and employs a staff of only 10. The center is headquartered in Cleveland, Ohio, and maintains state satellite offices in Independence, Mayfield and Austintown.
Stage one -- researching registration
Pursuing ISO 9001 registration was uncommon in the medical profession in 1994 and is still in the early stages of adoption throughout much of the industry. In fact, CCJR happened upon the idea much by chance, when Stulberg heard about ISO 9000 registration from colleagues in the manufacturing industry. He conducted some research and found that no quality assurance requirements existed for the private practice medical industry in the United States.
Believing that it couldn't hurt to look into the process further, and surprised that their field seemed to have no guidelines in this arena, Stulberg and his CCJR colleagues started a process that would later encompass the entire organization, from paperwork to patient care. Although ISO 9001 registration is not required for a private health care practice, CCJR decided to pursue registration in order to better serve its clientele.
The need for quality management
From 1992 to 1994, before CCJR researched and attained registration, it had no true quality management system. Therefore, the center began the process from ground zero. Which isn't to say the center didn't provide quality service; on the contrary, its methods were sound, and it helped many people. However, the process for managing and documenting these practices was neither thorough nor efficient.
For example, daily procedures went undocumented, making it hard to cross-train employees or hold employees accountable when activities were missed. Changes to procedures were made without sufficient training or preparation. The staff often duplicated efforts to ensure that activities were completed. The center needed to find a documentation method and management style that would enhance and improve the quality care it provided. Implementing a quality management system was the obvious choice.
In January 1994, CCJR hired a consultant to help plot the best course of action. Because center staff had little knowledge of ISO 9000 registration or the methods for attaining it, they found a consultant who had experience setting up ISO 9000 quality management systems in manufacturing groups in the area and was willing to research registration and its implications for a health care practice. Tim Weber, who was at the time president of ICON Consultants, worked with CCJR staff in reviewing the standards under the ISO 9000 heading. Weber suggested that the center use ISO 9001 for its quality management system.
ISO 9001 represents the quality system model for design/development, production, installation and servicing. CCJR's quality management system centers around developing and implementing care plans for specific patient populations such as those with arthritic hips or knees. The standard's requirements ensure that every aspect of the process remains consistent, from how the patient is registered, to the pre-operative assessment, to the follow-up care after surgery.
In testing the process, the center developed detailed checklists to prevent things from slipping through the cracks. For example, a detailed checklist for scheduling surgery includes everything from pre-certification to insurance, to organizing the patient's blood donations, to notifying the operating room team. The nurse clinicians document all pre-operative teaching and discharge planning. Set communication patterns between the practice and the hospital help the patient's hospital stay run smoothly.
Developing the system
The first thing CCJR tackled on its way to registration was interpreting the standards for a health care organization. This took time and effort. For example, what a customer-supplied product means in the manufacturing world differs in interpretation for a health care practice. Each clause of the standard was examined and discussed. Every aspect of handling patient care, from appointment scheduling to calibrating laboratory equipment and the X-ray machine, became documented procedures in the system.
Developing the documentation system proved to be a large project. Flow-sheet documentation for procedures streamlined the paperwork involved. Forms to document patients' progress were developed. CCJR already had a system for surveying and analyzing patient satisfaction after surgery, but it needed to be put into the system. Because the center already followed all legal requirements for maintaining medical records, controlling quality documents was well-established. However, this process had to be integrated with other parts of the new quality system. Forms for documenting training, purchasing and calibrating equipment were developed. Formal minute-taking was added to all meetings as part of management review.
Training the staff about ISO 9001 and the registration process comprised another key part of the process. Everyone had to stay briefed on the practice's progress and the standard's requirements. The training that ensued brought the staff up to speed on ISO 9001 -- what it is, what it does and what it doesn't do.
Gaining support
In order to reap all the benefits from its ISO 9001 quality management system, CCJR required complete support from the entire organization. Staff buy-in didn't happen until they realized that the new system would allow them to make a difference in the practice's day-to-day activities.
"The ISO 9001 system makes sure the staff addresses a problem and works together to find a solution," notes Karen Sanchez, a CCJR nurse. "Things don't just get swept under the carpet." The staff began to use the procedures for customer complaints and corrective actions to document how CCJR could improve the way it did business.
The registration process
Weber suggested that CCJR hire BSI Inc. as its ISO 9001 registrar. His decision was based on the registrar's history in the health care field, especially in the United Kingdom.
By July 1994, CCJR had its quality management system in place and was ready to begin the registration process. This began in March 1995, with a four-day initial audit. This determined how well the company complied with its stated quality policy, documented procedures and the ISO 9001 requirements. The registrar found no major nonconformities with CCJR's quality system but did find several minor nonconformities.
These fell under ISO 9001's Clause 4.5, covering document control. The nonconformities included review and approval documentation during the design process and references to external standards. CCJR's process for defining approved suppliers didn't sufficiently explain why a particular supplier was used. The center needed to implement a more accurate and comprehensive record-keeping technique. Also, the back-up of electronic media records wasn't documented. The registrar found other nonconformities in CCJR's internal audit documentation and procedures.
All in all, CCJR had the necessary procedures in place to run the organization and treat the patients. It simply needed a document control process that made the methods easier to follow and complied with the quality management system. The minor nonconformities were remedied to meet the ISO 9001 requirements. The auditors were fair, clear and helpful, and they guided CCJR through the learning process at a pace that satisfied all involved.
CCJR received ISO 9001 registration in May 1995, and its registrar continues to audit the center twice a year. The audits have proved very helpful to further develop and improve the center's quality management system. Much discussion ensues during every audit about future system improvements.
As a result of implementing ISO 9001, CCJR now has a detailed documentation plan for every facet of its business. The quality management system still involves a paper trail, but one that is necessary to ensure the practice runs smoothly. The center currently is computerizing its system, which will include the procedures mentioned here and an automated training file to assist employees with new techniques.
The practice also has implemented an extensive patient-satisfaction system to assess whether patients are well-treated. The patient-satisfaction procedures include everything from medical treatment to common office courtesy. Questions include: Are the patients' pains less now that they have received treatment at CCJR? Are they able to move better, and are they satisfied with their care? Were the nurses and doctors friendly and sympathetic? Were the phones answered quickly, and were patients treated with respect?
Registration benefits
CCJR has gained numerous benefits as a result of ISO 9001 registration. It noticed a significant drop in complications with patients after surgery. Furthermore, the center now can identify problems when they start. The system has helped CCJR stay on top of changes in managed health care and keep employees focused on what is important to the practice -- patient satisfaction.
Although these benefits don't produce hard numbers, the quality management system's effectiveness is evident in many respects. First, CCJR has had little staff turnover since registration. All the employees feel they have a say in the business practices, and because the system is so interactive, each employee plays a large role in maintaining CCJR's success. Employees know exactly who is responsible for what part of the patient care process.
Overall, staff members believe they are a valued asset to the team. They see that quality work gets accomplished, and they know that they are an important part of the process. Problems are resolved quickly and effectively, and the patients are happy and physically improved when they leave CCJR.
Continuing quality
CCJR believes that the health care field should institute some standardized measure of quality. Although medical and orthopedic procedures aren't as cut and dried as manufacturing procedures, ISO 9001 requirements are generic enough to fit virtually any company in any industry. The standard acts as a safety net to prevent problems from occurring.
The quality management system doesn't simply review complications and outcomes; it proactively addresses these possibilities before they arise. CCJR finds ISO 9001's discipline a helpful foundation in the center's continuous drive for customer satisfaction, streamlined and cost-efficient operations, and optimal use of resources, both human and material.
About the author
Laura M. Fox is director of operations for CCJR's quality program. She can be reached at fax (216) 736-7969. | 
