Introduction of A2LA’s Clinical - Executive War College · Introduction of A2LA’s Clinical ......

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Transcript of Introduction of A2LA’s Clinical - Executive War College · Introduction of A2LA’s Clinical ......

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

Clinical Accreditation Programs

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

What can A2LA do for you?

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)

Our Assessor Teams

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

How Does A2LA’s Fee Structure Work?

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 A2LA ?

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

Why Choose A2LA

Allows for the expansion of business offerings (e.g. clinical trials)

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

Questions?