The Future Role of Laboratory Inspections and Accreditation Sharon S. Ehrmeyer , Ph.D., MT(ASCP) 2011 ASCP Annual Meeting Sharon S. Ehrmeyer , Ph.D., MT(ASCP) Professor, Pathology and Laboratory Medicine University of Wisconsin Medical School, Madison, Wisconsin, USA
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The Future Role of Laboratory
Inspections and Accreditation
Sharon S. Ehrmeyer, Ph.D., MT(ASCP)
2011 ASCP Annual Meeting
Sharon S. Ehrmeyer, Ph.D., MT(ASCP)Professor, Pathology and Laboratory Medicine
University of Wisconsin Medical School, Madison, Wisconsin, USA
Future Role?
2011 ASCP Annual Meeting
The “Inspector”
2011 ASCP Annual Meeting
It’s only my strong, negative attitude that keeps me going. I will get you too!
ISO 15189 Accreditation and CLIA
Certification
2011 ASCP Annual Meeting
Accreditation
ISO 15189CLIA Certification
(CAP, TJC, COLA “accreditation”)
ISO (International Organization for
Standardization) states:� Accreditation is a “procedure by which an
authoritative body gives formal recognition that a
body or person is competent to carry out specific
tasks”
� Key words:
2011 ASCP Annual Meeting
� Authoritative body means a 3rd party organization
granted to accredit medical labs according to widely
recognized International Standards
� Competent means lab has to comply with “universal”
quality requirements, AND [demonstrate]
� Specific tasks that means to demonstrate specific
analytical and medical competences https://cdb.iso.org/cdb/ter
mentry!display.action?entr
y=185007&language=1
ISO States:Certification is a procedure...[where] a third-party
attestation (i.e., issue of a statement) that
specified requirements related to products,
processes, systems or persons have been
fulfilled (adapted from ISO/IEC 17000, 2005,
Definitions 5.2 and 5.5).
2011 ASCP Annual Meeting
Definitions 5.2 and 5.5).
� Key words:
� Attestation (issue of a statement)
� Specific requirements
� Fulfilled http://www.iso.org/sites/Consumers
Standards/en/5-glossary-terms.htm
Certification or Accreditation
� In the U.S., the term “accreditation” is used also for
laboratory licensing procedures and for certification of
conformance to procedures and processes, e.g., CLIA
� Examples of this difference in application of terms are the
College of American Pathologists (CAP) and Joint
2011 ASCP Annual Meeting
College of American Pathologists (CAP) and Joint
Commission (TJC), which “accredit” clinical laboratory
testing.
� According to ISO’s definitions, CAP and TJC would be
certification not accreditation programs
Libeer JC, Ehrmeyer SS: ISO 15189: A Worldwide Standard for
Medical Laboratories. Point of Care 3:1; 5-7, 2004.
Is it Certification or Accreditation?
2011 ASCP Annual Meeting
Confused?
Goal: ISO 15189 Accreditation
AND CLIA Certification:
2011 ASCP Annual Meeting
Quality test results for
quality patient care
ISO Accreditation or CLIA
Certification: (for quality purposes)
You say "either" and I say "either"
You say "neither" I say "neither"
"Either" "either", "neither" "neither"
2011 ASCP Annual Meeting
You say "potato," I say "patattah"
You say "tomato", I say “ tomata”
(for this discussion)
Oh, let's call the whole thing off!
ISO 15189 Accreditation and
CLIA Certification:
The “Devil is in the Details”
2011 ASCP Annual Meeting
ISO 15189 Accreditation: The Laboratory
World (outside US)
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� ISO, from the Greek isos, meaning "equal”
� ISO is a network of national standards institutes
� 161 countries (1 member /country); secretariat in
Geneva
www.iso.org
2011 ASCP Annual Meeting
Geneva
� ISO develops cooperation and international
standardization
� ISO facilitates exchange of goods and services
� 18 500 International Standards on many subjects
� 1100 new ISO standards are published every year
13
ISO15189 (2007)*
Medical Laboratories
– Particular
requirements for
quality and
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quality and
competence
*Will be updated in 2012
ISO 9001ISO 9001ISO 9001ISO 9001 ISO 15189ISO 15189ISO 15189ISO 15189ISO 17025ISO 17025ISO 17025ISO 17025
� 79,675 out of 225,746 testing sites must meet and
adhere to minimum requirements developed by
U.S. government agencies to test specimens
� Focus on quality practices including quality improvement
� (Waived testing sites must do only waived testing and
2011 ASCP Annual Meeting
� (Waived testing sites must do only waived testing and
follow manufacturers’ requirements)
� Can receive Medicare and Medicaid payments
� Can analyze samples from other laboratories
� Are subject to biannual inspection for compliance
and must respond to deficiencies, if found
Role of CLIA Certification
� Assures third- party payers (and government) that
sites at least meet minimum quality requirements
� Allows government to address
� Public expectations for testing only conducted by CLIA
2011 ASCP Annual Meeting
certified sites
� Concerns on escalating costs
� Concerns on excessive and esoteric testing
� Demand for test and cost accountability
� Provides a mechanism for government to
disseminate changes in testing requirements
Role of ISO 15189 Accreditation
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ISO 15189 Provides International
Recognition of Quality
� Requirements based on internationally
developed and accepted quality practices
� Allows test sites to adopt and be measured against
high quality, professional standards
� Provides a uniform framework
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� Provides a uniform framework
� Provide global recognition of labs and inspection facilities via the ILAC Arrangement � Allows for mutual evaluation and acceptance of data from accredited labs� Comparable data between testing sites
� Acceptance of data worldwide
ISO 15189 Provides International
Recognition of Quality
� Recognition for quality efforts� Allows for independent acknowledgement of
competency to carry out specific tasks (ISO 15189)
� Gives worldwide acknowledgement
� Proof of quality by “outside experts”� Provides credibility for increased customer
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� Provides credibility for increased customer
confidence (doctors, patients, public)
� Enhances national and international reputation
� Provides a credible marketing tool
� Promotion of quality efforts� Meets organizations’ expectations
� Builds staff morale
� Encourages continual quality improvement
In CONCLUSION, the Future is…
'It is in the interests of patients, of society, and of governments
that clinical laboratories operate at high standards of professional and technical competence…
2011 ASCP Annual Meeting
…and it is in the interests of competent laboratories that their competence
is verified through a process of inspection, comparison against appropriate standards, as a confirmation of their good standing’
D. Burnett, Consultant in quality and accreditation systems. AACC, 7/26/11