Standard Document
Third Edition
Quality Management Systems

CLSI QMS05

Qualifying, Selecting, and Evaluating a Referral Laboratory

CLSI QMS05 Ed3 provides expert guidance and easy-to-use processes to qualify, select, and evaluate a referral laboratory, ensuring regulatory compliance and quality

June 02, 2020
Laura McClannan, MS, MT(ASCP)SBB, CQA(ASQ)

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Abstract

Clinical and Laboratory Standards Institute guideline QMS05—Qualifying, Selecting, and Evaluating a Referral Laboratory provides laboratories with a defined process to identify candidate referral laboratories and consultants and qualify them for additional consideration. Important criteria that the laboratory should consider when selecting a referral laboratory or consultant are also provided. These criteria are the basis on which agreements for service are prepared and the referral laboratory's or consultant's performance in service delivery can later be evaluated.

Overview of Changes

This guideline replaces the previous edition of the approved guideline, QMS05-A2, published in 2012. Several changes were made in this edition, including: 

• Added a flow chart outlining the process to qualify, select, and evaluate a referral laboratory 

• Expanded content on qualifying and selecting a referral laboratory 

• Added new information on evaluating a referral laboratory 

• Included additional information in the appendixes

Scope

This guideline is intended for use by referring laboratories seeking a broad spectrum of services, a limited number of esoteric examinations, consultative services, or a backup service provider for examinations performed by the referring laboratory. This guideline provides recommendations for periodically evaluating the services provided by the referral laboratory. This guideline can also be used by referral laboratories to assist in understanding the qualification, selection, and evaluation process and what might be expected by them from a referring laboratory. 

The recommendations in this guideline include activities necessary to meet international and national published requirements for referral laboratories. The recommendations in this guideline are not meant as the only way to qualify, select, and evaluate referral laboratories. Referring laboratories can modify the suggested criteria, with the caveat not to delete criteria that reflect applicable regulatory and accreditation requirements for medical laboratories.

Product Details
QMS05Ed3E
978-1-68440-078-2
66
Authors
Laura McClannan, MS, MT(ASCP)SBB, CQA(ASQ)
Marie C. Earley, PhD
Deirdre Astin, MS, MT(ASCP)
Jennifer Daley-Bernier
Chakshu Gupta, MD
Sherri Hawkins
Dawn Maghakian, MS, MB(ASCP)CM, CGMBS
Megan Phillips, PhD
R. Ross Reichard, MD
Stephanie Whitehead, MBA, MPH, BS, MLS(ASCP)
Abstract

Clinical and Laboratory Standards Institute guideline QMS05—Qualifying, Selecting, and Evaluating a Referral Laboratory provides laboratories with a defined process to identify candidate referral laboratories and consultants and qualify them for additional consideration. Important criteria that the laboratory should consider when selecting a referral laboratory or consultant are also provided. These criteria are the basis on which agreements for service are prepared and the referral laboratory's or consultant's performance in service delivery can later be evaluated.

Overview of Changes

This guideline replaces the previous edition of the approved guideline, QMS05-A2, published in 2012. Several changes were made in this edition, including: 

• Added a flow chart outlining the process to qualify, select, and evaluate a referral laboratory 

• Expanded content on qualifying and selecting a referral laboratory 

• Added new information on evaluating a referral laboratory 

• Included additional information in the appendixes

Scope

This guideline is intended for use by referring laboratories seeking a broad spectrum of services, a limited number of esoteric examinations, consultative services, or a backup service provider for examinations performed by the referring laboratory. This guideline provides recommendations for periodically evaluating the services provided by the referral laboratory. This guideline can also be used by referral laboratories to assist in understanding the qualification, selection, and evaluation process and what might be expected by them from a referring laboratory. 

The recommendations in this guideline include activities necessary to meet international and national published requirements for referral laboratories. The recommendations in this guideline are not meant as the only way to qualify, select, and evaluate referral laboratories. Referring laboratories can modify the suggested criteria, with the caveat not to delete criteria that reflect applicable regulatory and accreditation requirements for medical laboratories.

QMS05Ed3E
978-1-68440-078-2
66
Authors
Laura McClannan, MS, MT(ASCP)SBB, CQA(ASQ)
Marie C. Earley, PhD
Deirdre Astin, MS, MT(ASCP)
Jennifer Daley-Bernier
Chakshu Gupta, MD
Sherri Hawkins
Dawn Maghakian, MS, MB(ASCP)CM, CGMBS
Megan Phillips, PhD
R. Ross Reichard, MD
Stephanie Whitehead, MBA, MPH, BS, MLS(ASCP)