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Introduction of A2LA’s Clinical Laboratory Accreditation Programs as the Sole Source of Domestic and International
Recognition
Presented at the 19th Annual Executive War College on Lab and Pathology Management
by Larnell C. Simpson
Director of Marketing/Medical AffairsA2LA
Overview
Introduce A2LA as a Deemed Accrediting Organization
Define A2LA’s mission and vision Introduce A2LA’s Clinical Accreditation Program
optionsDiscuss benefits of choosing A2LA as your
Accrediting Organization
About A2LA
Non-profit, public-service organization Accrediting a variety of testing laboratories
since1978 Largest multi-disciplined Accrediting Organization in
the U.S., fourth worldwide
More About A2LA
Has been a full voting member and recognized MRA Signatory to ILAC since 2000
Internationally renowned for participation in the ISO arena
Multiple domestic and international recognitions
A2LA’s Mission
Provide world-class accreditation and training services for testing and calibration laboratories, inspection bodies, proficiency testing providers, reference material producers and product certifiers. These and other future services should create stakeholder confidence in the quality, competence and integrity of all A2LA-accredited organizations and in their products and services.
Standards Medical Testing (CLIA and ISO 15189 ) Testing and Calibration (ISO/IEC 17025) Inspection Bodies (ISO/IEC 17020) Proficiency Test Providers (ISO/IEC 17043) Reference Material Producers (ISO Guide 34) Product Certification Bodies (ISO Guide 65)
*All programs with the exception of CLIA and PTP have been evaluated and are recognized under the ILAC MRA
A2LA Clinical Accreditation Program Options
CLIA only ISO 15189 only Platinum Choice-Dual Accreditation (CLIA +ISO
15189)
A2LA’s CLIA Accreditation Program
Granted CMS Deemed Status on March 25, 2014 to accredit to 42CFR493 under CLIA
Approved by CMS to accredit for all specialties and sub-specialties
First Accrediting Organization “deemed” by CMS since 1995
Only ILAC Signatory recognized by CMS
A2LA’s ISO 15189 Accreditation Program
Began accrediting medical laboratories in 2007Only US-based, peer reviewed accreditation
program recognized under the ILAC MRAOffers laboratories ability to gain CLIA accreditation
during annual review
A2LA’s ISO 15189 Accreditation Program
Recognized in 160+ countries Strong Management System Requirements Increases focus on Risk Assessment (ties into IQCP) Requires Measurement Uncertainty
“Platinum Choice” Dual Accreditation CLIA and ISO 15189
Only program worldwide recognized both domestically by CMS and internationally by ILAC
Offers dual accreditation from a single AO and single survey team
Benefit of QMS requirements of ISO 15189 and technical rigor of CLIA in a single assessment
“Platinum Choice” Dual Accreditation CLIA and ISO 15189
The most comprehensive review of laboratory quality and competence
Confers worldwide recognition of excellence in clinical laboratory performance
Overall Benefits of A2LA’s Clinical Laboratory Program
Offers laboratories three recognized accreditation options
Provides a simplified approach to dual accreditation from A2LA who has decades of accreditation experience spanning across multiple continents and specialized fields of testing
Reduces lab downtime on activities related to maintaining certification/accreditation
Overall Benefits of A2LA’s Clinical Laboratory Program
Combines and limits cost for dual assessments Flexibility in the creation of assessment team sizeCan choose to have additional assessors for
shorter on-site assessment period, or;Can choose to have smaller assessor teams for
decreased assessor on-site assessment cost
Overall Benefits of A2LA’s Clinical Laboratory Program
Laboratory has input to ensure no conflicts of interest exist in the assessment team
Two week announcement period prior to routine assessments
Renewal process completed before your anniversary date expires
Overall Benefits of A2LA’s Clinical Laboratory Program
Training offered specific to:Measurement UncertaintyRoot Cause Analysis and Internal AuditsISO 15189:2012Platinum Choice: ISO 15189 and CLIA
(in development)
A2LA Assessor Teams
A2LA Assessors teams include individuals who:Pathologist, MDs, PhDs, Medical Technologisthave successfully completed A2LA’s five day
classroom and interactive training coursehave passed a written examinationhave been evaluated by direct observation have a minimum of ten years experience in their
chosen areas of expertise
A2LA Assessor Teams
have extensive experience in assessing CLIA laboratories
are 3rd party independent sub-contractors are involved in CLSI and the writing of other
standards are retrained during A2LA’s Annual Technical
Forum
Fee Structure
A2LA fees:No additional administrative feesBased on menu pricing to control cost
(ISO 15189 only)Have individual satellite and branch system feesISO 15189 surcharge of $2,500/year (flat fee)
Fee Structure Based on fee per discipline (no longer based on
on-site assessment time) Potential reduction in the initial and ongoing
maintenance cost of accreditation Available four-year contract to allow laboratories
the ability to:Normalize cost over a four-year period, and; Submit budgets in advance
Why choose A2LADemonstrates leadership and willingness to invest
in qualityThe most comprehensive review of laboratory
quality and competenceEnhances patient safety and quality of outcomesEnhances your standing amongst internal and
external peers
Additional Information
Please visit us at www.A2LA.orgClinical Laboratory Accreditation Program PagesFederal Register NoticeTraining descriptions and schedulesA2LA ISO 15189 FAQsAll other A2LA recognized programs
For further information…
About the A2LA Clinical Laboratory Accreditation Program, please visit….
www.A2LA/medical.orgOr Contact
Larnell Simpson – [email protected] McDonald – [email protected]
Phone: (301) 644-3248