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

Hosted by Robert Michel
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Expect more hospitals and health systems to consider adopting the QMS of ISO 9001

It is certainly a sign of changing times when The Joint Commission (JC) enters into an arrangement that will give critical access hospitals the option to pursue The Joint Commission accreditation in combination with certification to ISO 9001.

This is a significant development. It can be assumed that The Joint Commission recognizes the growing interest hospital administrators have in adopting the quality management system (QMS) that is embedded within ISO 9001. Hospital laboratories, clinical laboratories, and anatomic pathology laboratories can earn accreditation to ISO 15189 Medical Laboratories, which also incorporates the QMS embedded within ISO 9001.

More Hospitals Are Interested in ISO 9001 Certification

Last November, The Joint Commission and SGS Group announced an alliance to offer coordinated accreditation and ISO certification, according to a JC press release. The program combines the commission’s quality and safety standards, survey process, and accountability performance measures with SGS’ management system audits. The SGS audits include certification to the ISO 9001 quality system standards.

During 2012, The Joint Commission (JC) and SGS will offer hospitals the option of meeting Medicare accreditation requirements with JC and working with SGS to earn certification to the standards of ISO 9001. In situations where hospitals decide to implement the QMS of ISO 9001, pathologists and clinical laboratory managers will be tasked with introducing the ISO 9001 requirements into their hospital laboratory organizations.

“Providing this enhanced service to health care organizations through the alliance of SGS and The Joint Commission is a natural progression for health care performance improvement,” said Anthony Perkins, Senior Vice President, Systems and Services Certification at SGS. “We are offering healthcare organizations an opportunity to take advantage of a number of ISO standards which complement Joint Commission accreditation requirements. This provides a method for hospitals to focus on improvements in quality and customer service in all departments, as well as their facility’s impact on the environment.”

According to the press release, the combination gives hospitals the tools to maintain best practices and lower costs across their entire operation. At the same time, they can remain focused on delivering quality health care to patients.

QMS of ISO 9001 Allows Precise Identification of System Vulnerabilities

“We are providing this option for hospitals and critical access hospitals in the United States that are interested in exploring the combination of ISO education and certification with Joint Commission accreditation as a mechanism to more precisely identify system vulnerabilities and inefficiencies,” stated Ann Scott Blouin, RN, Ph.D., FACHE, Executive Vice President, Accreditation and Certification Operations for The Joint Commission. “Future plans are to expand the option to organizations accredited under other Joint Commission accreditation programs.”

This new collaboration brings together two big players. Pathologists and clinical laboratory administrator know that The Joint Commission is the leading healthcare accrediting body in the United States. The JC says it evaluates and accredits more than 19,000 healthcare organizations and programs in the U.S., including more than 10,300 hospitals and home care organizations. It also evaluates and accredits more than 6,500 other healthcare organizations that provide long term care, behavioral healthcare, medical laboratory and ambulatory care services. For its part, SGS Group is one of the world’s largest control and inspection companies. It is represented in more than 130 countries by 210 affiliated companies.

Customized ISO Certification

With its announcement last fall, The Joint Commission became the latest healthcare accreditation body to offer an ISO-based certification or accreditation program within the United States. It was in September 2008 when the Centers for Medicare and Medicaid Services (CMS) granted deeming authority to Det Norske Veritas (DNV), allowing DNV to accredit hospitals to the Medicare Conditions of Participation. DNV will also help hospitals achieve certification to ISO 9001.

Also in 2008, the College of American Pathologists began to offer accreditation to CAP 15189 to clinical laboratories and anatomic pathology groups. This is CAP’s version of ISO 15189 Medical Laboratories.

Now that The Joint Commission has announced it will support hospitals that want to earn certification to ISO 9001, it can be expected that more hospital administrators will consider the benefits of implementing the QMS of ISO 9001 within their institutions.

As this happens within hospitals and health systems, it can be expected that hospital laboratory managers and pathologists will find it easier to gain approval to have their laboratories implement the QMS of either ISO 9001 or ISO 15189.

Pamela Scherer McLeod

Related Information:

Joint Commission and SGS form an Alliance to offer Coordinated Accreditation and

ISO Certification Option

Joint Commission, SGS Form Alliance for Coordinated Accreditation

Joint Commission Forms Alliance With SGS for Coordinated Accreditation

CMS Approves Norwegian Company for Hospital Accreditation in the U.S.

St. Elizabeth Medical Center May Be First U.S. Hospital to Hold Three ISO Accreditations

Lab Industry’s Quality Gurus Gather and Share Best Practices