CEO SUMMARY: In Utica, New York, 201-bed St. Elizabeth Medical Center was the first hospital in New York State and one of the first five hospitals nationwide to meet the new accreditation standard from DNV Healthcare, of Cincinnati, Ohio. St. Elizabeth administrators credit use of this new accreditation process in helping the hospital improve efficiency, patient satisfaction, and employee retention. Meeting the DNV accreditation standards was relatively easy because the facility was already accredited for ISO 9001 and ISO 14001 from the International Organization for Standardization (ISO).
FOR HOSPITAL ACCREDITATION, there’s a new player in town. Last fall, DNV Healthcare, Inc. (DNV), of Cincinnati, Ohio, was approved by the Centers for Medicare and Medicaid Services (CMS) as a hospital accreditation program in the United States.
This changes the accreditation landscape in two ways. One, DNV Healthcare, a division of Norway-based Det Norske Veritas, becomes the first new hospital accreditation competitor for The Joint Commission in 40 years. Two, DNV’s accreditation program allows hospitals and other healthcare organizations to meet Medicare accreditation criteria while at the same time achieving ISO 9001 accreditation.
For hospital laboratories and pathology group practices, this development is likely to have long-term consequences. That is because, in one stroke, CMS increased competition for hospital accreditation while giving hospitals an option that allows them to pursue ISO 9001 accreditation.
Accreditation Through DNV
To learn more about DNV’s hospital accreditation process and the different ways it may involve laboratories and pathology groups, THE DARK REPORT contacted St. Elizabeth Medical Center in Utica, New York. This 201-bed medical center is the first hospital in New York State and one of the first five hospitals nationwide to meet the new accreditation standard from DNV Healthcare.
Currently, DNV has accredited 20 hospitals in the United States. The accreditation confirms that St. Elizabeth is meeting Medicare and Medicaid’s standards to provide healthcare services and is meeting the National Integrated Accreditation for Healthcare Organizations (NIAHO) standards for ISO 9001 from the International Organization for Standardization (ISO).
St. Elizabeth is a first-mover in these achievements. It was the 12th hospital to be accredited to ISO 9001 in the United States. In 2005, it became the first hospital to hold dual certifications in ISO 9001 and ISO 14001:Environmental Management, said David Briggs, St. Elizabeth’s Quality Director. Now that it works with DNV, St. Elizabeth is no longer accredited by The Joint Commission, the longtime leader in hospital accreditation in the United States.
According to Briggs, accreditation is about more than meeting standards. “By learning how to be more efficient, St. Elizabeth has increased the number of patients it treats without adding to capacity,” observed Briggs. “Our medical center also increased its patient satisfaction ratings and its employee retention numbers. We attribute both of these improvements to pursuing ISO accreditation.”
Last October, the federal Centers for Medicare & Medicaid Services (CMS) announced that it would allow DNV to accredit hospitals. Two months later, St. Elizabeth’s dropped its longstanding affiliation with The Joint Commission in favor of DNV.
“It was both a practical and a philosophical issue for us,” Albert D’Accurzio, M.D., the medical center’s Vice President of Medical Affairs, told HealthLeaders magazine. “If we wanted to maintain ISO certification and use The Joint Commission for our CMS accreditation, we would have undergone two different surveys by two different organizations. This is a simpler process.”
St. Elizabeth’s President and CEO, Sister M. Johanna, believes DNV is more than a new accreditation program. “It’s a catalyst for our ongoing commitment to patient safety and clinical quality,” she said. “With NIAHO, we can achieve full ISO compliance and satisfy our annual accreditation requirements at the same time, for no additional cost. Quite literally, it is a win-win for us, our patients, and our community.”
What sets St. Elizabeth apart from many other hospitals is that the ISO standards are the foundation of the medical center’s quality management system, which ensures that the medical center is taking all necessary steps to deliver safe and effective healthcare services to patients.
In the clinical laboratory, there is another benefit. The lab is accredited by the College of American Pathology (CAP) and the New York State Department of Health. “Since both of these entities have accreditation standards similar to those of ISO, the lab was more prepared than any other hospital department when it was time to make the transition to DNV accreditation,” stated Briggs.
“As our hospital went through this process, the clinical lab was one of the most supportive departments,” Briggs commented. “That is because the laboratory is CAP-certified and there are similarities to DNV in terms of accreditation standards.
DNV Accreditation Standards
“It meant our lab was functioning somewhat ahead of our organization in this regard,” he explained. “While there were minor formalities relative to structure, it was not as difficult for our clinical laboratory to comply with the DNV accreditation standards as it was for other departments in the hospital.
“And now CAP is pursuing ISO 15189 as a standard for clinical laboratory accreditation,” Briggs continued. “Recognizing the value of ISO 15189, we are working on a project now to be certified for ISO 15189 and we would like to get that done in the next two years.”
While using DNV for Medicare accreditation requirements only became possible late last year, the hospital has worked with ISO accreditation for seven years. “We started the journey to ISO in 2002, and we have been ISO 9001 accredited since 2005,” Briggs explained. “In that sense, it was a natural evolution to pursue Medicare accreditation through DNV.
“That’s because the NIAHO standards for the DNV accreditation are integrated and blend the requirement to comply with the conditions of participation from CMS with compliance with ISO 9001 standards,” stated Briggs. “What is new to healthcare in the United States is to be compliant with the ISO 9001 standard.
Already ISO 9001 Accredited
“Given that we were already compliant with the ISO 9001 standard, it was natural that we would seek DNV accreditation to meet Medicare program requirements,” he said. “We believe our ISO accreditation distinguishes us from most other facilities. For us, ISO accreditation has been a good business decision.”
St. Elizabeth Medical Center adopted quality management methods during the 1980s and 1990s. ISO accreditation was a logical next step in transforming its management culture. “We decided to pursue ISO accreditation for several reasons,” recalled Briggs. “At that time, we believed we had taken total quality management (TQM) about far as it could go.
“Next, we recognized that many quality management systems are built on a reactive approach to situations,” he continued. “Thus, it often takes some external stimulus, such as a failure of some kind, to trigger the quality system review. At St. Elizabeth, we wanted to be more proactive and manage quality from the ‘system of prevention’ mind set.
Structured Quality System
“So, as we considered moving from TQM to a Six Sigma quality management system, we quickly recognized that we would need to deploy Six Sigma as a structured system hospital wide,” Briggs added. “That was necessary to realize sustained benefits from other quality improvement methods.
“Thus, our natural evolution in quality management was to build a system that would be used in every department of the hospital,” he said. “The ISO 9000 standard met our specification for a quality management system because we could hard-wire the effort in every department and it would be sustainable.
A Natural, Logical Addition
“We achieved ISO 9001 accreditation in 2005,” Briggs commented. “The same year, we also achieved the ISO 14001 accreditation, which is a standard for environmental management systems designed to decrease the pollution and waste a business produces.
“When it became possible to use DNV for our Medicare accreditation, that was a natural step,” he stated. “Now we have accreditation under DNV (for Medicare), ISO 9001, and ISO 14001. Because all three are built on the same quality management platform, it simplifies the process for us and puts us all under one house for accreditation.”
Briggs discussed some of the key changes required to pursue these accreditations. “For example, control of documents and documentation management was a major project,” he observed. “Implementing systems to manage documents was a fairly significant task. We implemented formal corrective action and internal audit programs.
“Another big change in working environment was to teach staff how to work with continual improvement as a defined process.
“Since becoming accredited to ISO 9001, it’s possible to see the advantages to our hospital over time,” commented Briggs. “We know that we are accomplishing continuous improvement. In turn, that is moving our patient and customer satisfaction numbers in a positive direction.
“In addition, we believe these accreditations give us a competitive advantage,” he added. “It helps us produce a better product and we know that from our own internal staff surveys, our outside patient satisfaction surveys, our patient volume, and our employee retention rate.
“Last year, for example, we discharged roughly 800 more patients in 2008 than we did in 2007,” he said. “That healthy growth came from increases in efficiency because we had the same number of beds: 201. Increasing efficiency allows us to increase throughput,” noted Briggs.
“Another way to qualify our results is to consider how our competitors view us in the Utica market,” he added. “We have another hospital across town that is a bit larger than we are. There are hospitals in Rome, Oneida, and Hamilton, and each of these four hospitals is in a primary or secondary market for us. I have fielded inquiries from some of these facilities, asking questions about the ISO/NIAHO process offered by DNV Healthcare.
Achieving 6-Sigma Quality
“In fact, for the past 40 years, the healthcare system has had one way of operating, yet it continues to struggle to maintain a 2-Sigma or 3-Sigma level of quality. Outside of healthcare, many industries are reaching 5- Sigma and 6-Sigma quality levels. Healthcare must change to achieve similar quality levels. This is one reason why I supported the introduction of the ISO philosophy here at our medical center.”
THE DARK REPORT observes that St. Elizabeth Medical Center is a first mover in the American hospital industry because of its use of DNV’s dual Medicare and ISO 9001 accreditation service. It is significant that hospital administration is enthusiastic about the benefits which result from this dual accreditation service.
From a patient care and revenue perspective, St. Elizabeth was able to discharge 800 more patients in 2008 compared to 2009, without any increase in its 201-bed facility. It attributes this improvement to better work flow within the hospital because of how it uses quality management methods to improve individual work processes and outcomes.
Another benefit results because many of the biggest employers in the region understand how ISO 9001 accreditation contributes to higher quality and better customer service. As an ISO 9001-accreditated hospital, this achievement gives St. Elizabeth additional competitive advantage in its marketplace.
Perceptive pathologists and laboratory administrators probably also noticed the comments about the “non-punitive” nature of the accreditation process followed by DNV Healthcare. This is consistent with effective use of quality management systems, where the objective is continuous improvement by recognizing sources of errors and fixing them.
It is also obvious that administrators at St. Elizabeth Medical Center are quite satisfied with the DNV Healthcare approach to hospital accreditation. This may be a sign of an impending competitive shift in the hospital marketplace as other hospitals decide to use the dual DNV and ISO 9001 option for accreditation.
CAP, ISO Processes Put St. E’s Laboratory Ahead of the Curve for DNV Accreditation
LAB DIRECTORS AND PATHOLOGISTS may wonder what it’s like to go from being accredited by the Joint Commission to being accredited by DNV Healthcare. After all, the Joint Commission in Oakbrook Terrace, Illinois, is the long-time market leader in hospital accreditation. DNV in Cincinnati is the new rival upstart. DNV earned deeming status from the federal Centers for Medicare & Medicaid Services last fall.
St. Elizabeth Medical Center in Utica, New York, earned Medicare accreditation last December using DNV. It was one of the first hospitals in the United States to use DNV for a dual Medicare and ISO 9001 designation. For St. Elizabeth’s clinical laboratory, the transition was relatively painless.
“In terms of the ISO accreditation, we were a bit ahead of the curve and that’s because we were already extensively regulated by the Joint Commission, the College of American Pathologists, and the New State Department of Health,” said Lab Manager Kathy Inglis, MS, MT/ASCP.
“Our lab was already using control charts and statistics for managing processes,” she added. “Therefore, the DNV accreditation steps were not new to us.”
Billable Tests Per Year
The laboratory performs about 850,000 billable tests per year. Outreach testing makes up about 30% to 40% of total volume. In addition to serving the 201-bed facility, the laboratory serves five nursing homes and 14 clinics. The lab has 74 employees and two contracted pathologists.
“CAP and the New York State Department of Health follow many of the ISO and CLSI standards,” Inglis noted. “So our laboratory found it a natural transition to meet the ISO standard. Even though our lab is not certified to ISO 15189:Medical Laboratories, we will look at starting that process in the next year or two.
“ISO requires your laboratory to focus on key quality indicators,” she continued. “Among other things, it encourages you to listen to the voice of the customer to develop those indicators, then use outcomes to guide improvement efforts,” Inglis stated. “Your customers will include anyone interacting with your laboratory. That ranges from physicians and nursing staff, to patients and your laboratory staff.
ISO 9001 Standards In Lab
“Once our lab met the ISO 9001 standards, we’ve seen many positive outcomes, including reduced turnaround time,” Inglis said. “For morning lab tests, we consistently report results by 7 a.m. for intensive care patients and by 9 a.m. for regular inpatients. Before starting our ISO accreditation process several years ago, the lab met morning turnaround times only about 50% of the time.
“Each area in the lab that we have attacked with an improvement project has produced worthwhile gains, including patient satisfaction with phlebotomy and our error rate,” she added. “For example, the rate of hemolyzed specimens from the emergency room has improved—in part because of improved communication between departments.
“In the past, the ER staff often drew blood using an IV catheter,” Inglis observed. “About 50% of those samples were hemolyzed. As part of a joint improvement project, we asked the ER staff to use straight sticks and venipunctures. That has sharply reduced the rate of hemolyzed specimens to a level that is now at the national average. As a result of working together more effectively with the ER staff, line draws have been almost eliminated.”
New Accreditation Processes From DNV Put the Focus on Non-Punitive Environment
HOSPITAL LABORATORY DIRECTORS may be interested to know that there are sharp differences between a typical Joint Commission accreditation audit and a DNV Healthcare accreditation survey.
“From a staff perspective, one difference we noticed was that the DNV accreditation reinforced a significant change in attitude,” said David Briggs, Quality Manager for St. Elizabeth Medical Center. “DNV focuses on the ‘just culture’ philosophy, which holds that human beings will make errors and when they do, processes are often at fault.
“We continue to deploy that idea by developing a non-punitive environment,” he explained. “When an error occurs, we look first at the processes involved. Then, if human error is involved, we determine whether that human error was intentional or not.
“Because this approach removes the fear, it helps us get more out of our performance improvement activities,” Briggs continued. “Previously, it wouldn’t be uncommon that, when external surveyors were on site, staff would be advised to provide a simple answer to surveyors’ questions and not offer additional information.
“But DNV’s accreditation process is highly collaborative. In turn, that encourages our staff to be open and work closely with the surveyors,” he said. “In fact, we ask staff to be open because we know that the accrediting surveyors are here as an integral part of our quality improvement activities.
“Essentially, the entire accreditation survey process is now viewed by most as a benefit to our organization,” added Briggs. “At the same time, the staff members also consider that they have a voice and can contribute to improving processes and outcomes.
“One example of this positive difference during the accreditation process is that, when the surveyors are scheduled, we do absolutely nothing to get ready,” Briggs said. “In fact, the surveys are unannounced. We know roughly when they’re coming and so we may identify who will be around when the surveyors are here. But that’s it. Then, when surveyors arrive at our hospital, it tends to go smoothly.”