Standard Document
First Edition
Quality Management Systems

CLSI QMS26

Managing Laboratory Records

CLSI QMS26-Ed1 features vetted recommendations for creating a laboratory records management program. These guidelines will ensure lab professionals are able to design, create, review, retain and dispose of laboratory records properly, ensuring an organized system and proper practice.

April 14, 2021
Karen Heaton, MLT(CMLTA)

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Abstract

Clinical and Laboratory Standards Institute guideline QMS26—Managing Laboratory Records presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records.

Scope

This guideline is intended to help laboratories meet QMS requirements for the records portion of quality system essential (QSE) Documents and Records Management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records. This guideline can be used in laboratories worldwide and is intended for use primarily by:

• Medical laboratories

• Blood gas laboratories

• Blood donor and pretransfusion testing laboratories

• Public health laboratories

• Clinical research laboratories

However, because the concepts of records management are generic, this guideline is also applicable to other types of laboratories, including but not limited to:

• Food laboratories

• Environmental laboratories

• Veterinary laboratories

This guideline does not specifically cover management of specimens and clinical materials (e.g., pathology blocks and slides, blood and body fluid specimens), which also requires appropriate retention and disposal. However, many of the concepts contained in this guideline could be applied to management of these materials. Refer to CLSI document QMS01 for more information about specimen management. This guideline does not cover the documents portion of QSE Documents and Records Management. Refer to CLSI document QMS02 for more information on document management.

Product Details
QMS26Ed1E
978-1-68440-107-9
80
Authors
Karen Heaton, MLT(CMLTA)
Debra Kuehl, MS, M(ASCP)
Kathleen A. Grindle, MT(ASCP),CQA(ASQ)CPGP
Sheri L. Hearn, BS, MPH
Phillip P. Morehouse, MLT, CMQ/OE(ASQ)
Jennifer O'Neill, BSc
Donna Roberts, MS, MT(ASCP)
Doreen M. Ryan, MT
Denise Tevis, MS
Arno Pieter Theron
Joanne M. Vaillant, MLT
Abstract

Clinical and Laboratory Standards Institute guideline QMS26—Managing Laboratory Records presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records.

Scope

This guideline is intended to help laboratories meet QMS requirements for the records portion of quality system essential (QSE) Documents and Records Management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records. This guideline can be used in laboratories worldwide and is intended for use primarily by:

• Medical laboratories

• Blood gas laboratories

• Blood donor and pretransfusion testing laboratories

• Public health laboratories

• Clinical research laboratories

However, because the concepts of records management are generic, this guideline is also applicable to other types of laboratories, including but not limited to:

• Food laboratories

• Environmental laboratories

• Veterinary laboratories

This guideline does not specifically cover management of specimens and clinical materials (e.g., pathology blocks and slides, blood and body fluid specimens), which also requires appropriate retention and disposal. However, many of the concepts contained in this guideline could be applied to management of these materials. Refer to CLSI document QMS01 for more information about specimen management. This guideline does not cover the documents portion of QSE Documents and Records Management. Refer to CLSI document QMS02 for more information on document management.

QMS26Ed1E
978-1-68440-107-9
80
Authors
Karen Heaton, MLT(CMLTA)
Debra Kuehl, MS, M(ASCP)
Kathleen A. Grindle, MT(ASCP),CQA(ASQ)CPGP
Sheri L. Hearn, BS, MPH
Phillip P. Morehouse, MLT, CMQ/OE(ASQ)
Jennifer O'Neill, BSc
Donna Roberts, MS, MT(ASCP)
Doreen M. Ryan, MT
Denise Tevis, MS
Arno Pieter Theron
Joanne M. Vaillant, MLT