News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Utica Hospital holds accreditation in ISO 9001 and 14001, may pursue 15189

When the federal Centers for Medicare and Medicaid Services (CMS) approved DNV Healthcare, Inc. , of Cincinnati, Ohio, to accredit hospitals in the United States last fall, it changed the accreditation landscape significantly. A division of Det Norske Veritas of Oslo, Norway, DNV Healthcare is the first new hospital accreditation competitor for The Joint Commission http://www.jointcommission.org in 40 years. The Joint Commission is the longtime leader in hospital accreditation in the United States.

Among the first hospitals to use this new Medicare accreditation program was St. Elizabeth Medical Center in Utica, New York. One compelling reason why St. Elizabeth used DNV to pursue Medicare accreditation was that it already held ISO 9001 accreditation and the DNV accreditation process enables hospitals to earn accreditation under both programs. Based in its successful experience with DNV and with ISO 9001, St. Elizabeth’s administrators and clinical laboratory managers expect to pursue ISO 15189:Medical Laboratories accreditation within the next two years.

In fact, Dark Daily believes that St. Elizabeth Medical Center is a first-mover in a trend that will touch hospital laboratories across the United States. St. Elizabeth is committed to quality and actively reshaping its organizational culture to encourage staff to continuously improve workflow and clinical services in ways that improve patient care and increase patient satisfaction. And, ahead of its hospital peers, St. Elizabeth has chosen ISO as a foundation for achieving this organizational goal.

St. Elizabeth was the 12th hospital to be accredited to ISO 9001 in the United States. It was also one of the first five hospitals to be accredited by DNV when it was accredited in December. The hospital is committed to quality. Back in 2005, it became the first hospital in the nation to hold dual certifications in ISO 9001 and ISO 14001:Environmental Management, said David Briggs, St. Elizabeth’s Quality Director. Following its Medicare accreditation with DNV, the 201-bed medical center is no longer being accredited by The Joint Commission.

Recently, Dark Daily’s sister publication, The Dark Report interviewed the quality leaders and clinical laboratory manager at St. Elizabeth to learn how this organizational goal of quality pursued through ISO accreditation was benefiting the hospital. “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,” explained Briggs. “We believe our ISO accreditation distinguishes us from most other facilities. For us, ISO accreditation has been a good business decision.”

Pathologists and laboratory directors will be interested to learn that the clinical laboratory at St. Elizabeth Medical Center was well prepared for the transition to DNV accreditation because the lab was already accredited by the College of American Pathology (CAP) and the New York State Department of Health. The accreditation standards of both of these entities are similar to those of ISO. “As a result, the lab was more prepared than any other hospital department when it was time to make the transition to DNV accreditation,” Briggs explained.

“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.

In an article in the June 8 issue The Dark Report, Briggs also pointed out that one measurable benefit from implementing ISO 9001 at St. Elizabeth has been increased patient throughput. “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: 200. Increasing efficiency allows us to increase throughput. (See “Accreditation with DNV Helps Hospital Raise Inpatient Volume,” The Dark Report, June 8, 2009 .)

Clinical laboratories and anatomic pathology groups are likely to see more hospitals in the United States consider ISO 9001 accreditation in tandem with the accreditation requirements of the Medicare program. Not only is ISO 9001 an effective way to implement a strong quality program within the organization, but the largest customers of most hospitals—the major employers in their communities—are ISO-accredited themselves and recognize the value of that achievement.

For similar reasons, there are clinical laboratories in the United States now taking steps to earn accreditation under ISO 15189:Medical Laboratories. This is an infant trend, with less than five laboratories in the United States holding an ISO 15189 accreditation at this time. But that number is guaranteed to grow, as several U.S. laboratories are currently in the process of qualifying for ISO 15189 accreditation.

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Related Articles:

Accreditation with DNV Helps Hospital Raise Inpatient Volume,” The Dark Report, June 8, 2009

“St. Elizabeth Accredited By New Quality Authority”

“Medicare Grants DNV Healthcare Deeming Authority for U.S. Hospitals”

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