Archived Document

This archived document is no longer being reviewed through the CLSI Consensus Document Development
Process. However, this document is technically valid as of September 2017. Because of its value to the
laboratory community, it is being retained in CLSI’s library.

December 2006

AUTO08-A

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Managing and Validating Laboratory
Information Systems; Approved Guideline
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This document provides guidance for developing a protocol for

validation of the laboratory information system (LIS), as well as
protocols for assessing the dependability of the LIS when storing,
retrieving, and transmitting data.

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.
Clinical and Laboratory Standards Institute
Setting the standard for quality in medical laboratory testing around the world.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings
together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a
common cause: to foster excellence in laboratory medicine by developing and implementing medical laboratory
standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global
applicability.

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Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the
development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the
participants in the development of a consensus document have considered and resolved all relevant objections

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and accept the resulting agreement.

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CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies,

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procedures, methods, and protocols affecting the laboratory or health care.

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draft document as appropriate.

Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on
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any document. All comments are managed according to the consensus process by a committee of experts.

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When it is believed that an objection has not been adequately considered and responded to, the process for
appeals, documented in the CLSI Standards Development Policies and Processes, is followed.
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 AUTO08-A
Vol. 26 No. 36
ISBN 1-56238-624-7 Replaces AUTO8-P
ISSN 0273-3099 Vol. 25 No. 2
Managing and Validating Laboratory Information Systems; Approved
Guideline
Volume 26 Number 36
Sandy Pearson, MT(ASCP)
Ulysses J. Balis, MD

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John Fuller
Brad Kowalski, MBA
Angela P. Locke, MT(ASCP)
Deborah Tillman
Quynh H. Vantu, MS, MT(ASCP)BB

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Abstract
Clinical and Laboratory Standards Institute (CLSI) document AUTO08-A—Managing and Validating Laboratory Information
Systems; Approved Guideline identifies important factors that laboratory managers should consider when developing a protocol
for the validation of the laboratory information systems (LIS). Also included are recommendations to help prepare validation
protocols for assessing the accuracy and dependability of the LIS in storing, retrieving, and transmitting data.
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Clinical and Laboratory Standards Institute (CLSI). Managing and Validating Laboratory Information Systems; Approved
Guideline. CLSI document AUTO08-A (ISBN 1-56238-624-7). Clinical and Laboratory Standards Institute, 950 West Valley
Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2006.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through
two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any
given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or
guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in
the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become
one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail:
[email protected]; Website: www.clsi.org.
Number 36 AUTO08-A

Copyright ©2006 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of
content from a CLSI copyrighted standard, guideline, companion product, or other material requires
express written consent from CLSI. All rights reserved. Interested parties may send permission requests to
[email protected].

CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of
this publication for use in its laboratory procedure manual at a single site. To request permission to use

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this publication in any other manner, e-mail [email protected].

Suggested Citation

CLSI. Managing and Validating Laboratory Information Systems; Approved Guideline. CLSI document

January 2005

Archived:
September 2017
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AUTO08-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2006.

Previous Edition:
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ISBN 1-56238-624-7
ISSN 0273-3099

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Volume 26 AUTO08-A

Contents

Abstract ....................................................................................................................................................i

Committee Membership........................................................................................................................ iii

Foreword .............................................................................................................................................. vii

1 Scope.......................................................................................................................................... 1

2 Introduction ................................................................................................................................ 1

3 Terminology............................................................................................................................... 2
3.1 Definitions .................................................................................................................... 2

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3.2 Acronyms ...................................................................................................................... 5
4 Computer System Facilities ....................................................................................................... 5
4.1 Environmental Conditions and Safeguards for Proper System Operations .................. 5
4.2 Preventive Maintenance for Computer Systems ........................................................... 7

6
4.3

5.2
5.3
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Disaster Recovery ......................................................................................................... 9
Systems Programs .................................................................................................................... 10
5.1 Laboratory Accreditation/Regulatory Requirements .................................................. 10
Security/Access ........................................................................................................... 10
Changes to Existing Programs or Validation of New Programs ................................. 17
Data .......................................................................................................................................... 18
6.1 Registration and Requisition Information ................................................................... 18
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6.2 Data Entry ................................................................................................................... 20
6.3 Computer Calculations ............................................................................................... 23
6.4 Autoverification of Transmitted Results ..................................................................... 23
6.5 Generated Reports....................................................................................................... 24
7 Quality Assurance Standards/CQI ........................................................................................... 27
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7.1 User Responsibilities .................................................................................................. 27

7.2 Database Maintenance ................................................................................................ 35
7.3 Certification of Interfaces ........................................................................................... 35
7.4 Problem Reporting and Tracking ................................................................................ 37
7.5 Train Staff ................................................................................................................... 39
7.6 Postimplementation Monitoring ................................................................................. 39
7.7 Documentation and Record Retention ........................................................................ 40
References ............................................................................................................................................. 42

Additional References ........................................................................................................................... 43

Appendix A. Sample Change/Addition Request Form ......................................................................... 44

Appendix B. Example of Change/Addition Request ............................................................................ 45

Appendix C. Validation Script .............................................................................................................. 46

Summary of Consensus Comments and Committee Responses ........................................................... 47

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Number 36 AUTO08-A

Contents (Continued)
The Quality System Approach .............................................................................................................. 56

Related CLSI/NCCLS Publications ...................................................................................................... 57

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Volume 26 AUTO08-A

Foreword
There are many automated systems that a laboratory must interface with, both internal and external to the
laboratory. Clinical and Laboratory Standards Institute (CLSI) has a number of approved automation
standards that address individual portions of an automated laboratory system. These approved standards
cover the path of workflow in a laboratory (preexamination, examination, postexamination, and
information management), yet there are no standards or guidelines that incorporate all these systems into
a laboratory-wide validation process. This guideline contains recommendations for the preparation and
execution of a laboratory information system (LIS) validation process. A laboratory information system
(LIS) is also referred to as a clinical laboratory information management system (CLIMS) or laboratory
information management system (LIMS) in some current publications. For consistency, this document
will use the term LIS throughout when referring to these types of systems.

Key Words

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Audit trail, interface, network, system, validation, verification

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vii
Volume 26 AUTO08-A

Managing and Validating Laboratory Information Systems; Approved

Guideline

1 Scope
The laboratory industry is quickly moving into the era of electronic reports, transmission of information
via the Internet, etc., and there is a need to develop guidelines that can provide consistency in the
industry. The purpose of this guideline is to address the validation of LIS systems and any interface to an
external system (e.g., electronic health record system [EHRS], formerly known as a hospital information
system [HIS], point-of-care device [POCD], reference laboratory, data repository, instrumentation,
laboratory automation system [LAS], or financial system) to ensure that information is accurate and
reliable during sample accessioning, transmittal of test results, and throughout the system’s intended use.
This guideline addresses the validation process as it relates to:

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 data entry;
 data analysis;
 data verification;



data transmission;
data storage; and
data retrieval.
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The primary focus of AUTO08-A is on the software within the clinical laboratory environment.
Therefore, the recommendations presented in AUTO08-A are not directly applicable to over-the-counter
devices or software on instruments. The document is intended for use by: laboratory compliance officers,
laboratory LIS staff (e.g., LIS coordinator, system administrator), vendors of LIS and associated
hardware, IT staff responsible for LIS, and network administrators.
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2 Introduction
An LIS manages data related to test requisitions, patient demographics, and specimens. An LIS can either
interface with the laboratory analytical and process instruments as the data management center or serve
for data collection, reporting, transmission, and archiving. An LIS can also interface with other
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information systems (e.g., electronic health record system [EHRS]) for the transmission of test
requisitions and final test results.

As stated previously, CLSI has a number of different approved standards that address individual portions
of an automated laboratory system (path of workflow):

AUTO1: Laboratory Automation: Specimen Container/Specimen Carrier provides standards for the
design and manufacture of specimen containers and carriers used for collecting and processing liquid
samples for clinical testing in laboratory automation systems.

AUTO2: Laboratory Automation: Bar Codes for Specimen Container Identification provides
specifications for use of linear bar codes on specimen container tubes in the clinical laboratory and for use
on laboratory automation systems.

AUTO3: Laboratory Automation: Communications with Automated Clinical Laboratory Systems,

Instruments, Devices, and Information Systems provides standards to facilitate accurate and timely
electronic exchange of data and information among the automated laboratory elements.

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Clinical and Laboratory Standards Institute. All rights reserved. 1
Number 36 AUTO08-A

AUTO4: Laboratory Automation: Systems Operational Requirements, Characteristics, and Information

Elements defines system status information that supports laboratory-automated systems.

AUTO5: Laboratory Automation: Electromechanical Interfaces defines a standard, compatible

connection between instruments and automation technology that will enable the user to create an
automated laboratory environment.

AUTO10: Autoverification of Clinical Laboratory Test Results provides a general framework that will
allow each laboratory to easily design, implement, validate, and customize rules for autoverification based
on the needs of its own patient population.

GP19: Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and
End-User Software Systems Validation, Operation, and Monitoring describes factors to be considered
when developing new software-driven systems and selecting software user interfaces. Included are simple
rules to help prepare validation protocols for assessing the functionality and dependability of software.

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POCT1: Point-of-Care Connectivity provides a design framework for workstations and interfaces with an
LIS.

Path of Workflow
Preexamination
AUTO1
AUTO2
AUTO3
AUTO4
AUTO5
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Examination Postexamination
AUTO3
AUTO4
Information Management
AUTO3
AUTO4
AUTO10
GP19
POCT1

AUTO08-A provides guidance for the development of a validation system for data management, which
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will incorporate all interfacing systems, both inside and outside the laboratory. It identifies those elements
that should be included in a validation system and the critical areas that should be considered in the
validation process.

In the modern clinical laboratory, it is necessary for a laboratory to use and interface with different
automated systems. It is important that laboratory staff validate the integration/operation of all automated
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systems to ensure the accuracy of all test information.

AUTO08-A specifications are also intended to complement the interrelated CLSI/NCCLS standards
developed by other automation subcommittees and to support overall operational goals for future
development in laboratory instrumentation and automation.

3 Terminology

3.1 Definitions

accuracy (of measurement) – closeness of the agreement between the result of a measurement and a true
value of the measurand (VIM93)1; closeness of agreement between a test result and the accepted reference
value (ISO 3534-1)2; NOTE 1: A qualitative assessment of correctness or freedom from error; NOTE 2:
A quantitative measure of the magnitude of error. Contrast with precision (IEEE 610.12-1990)3; NOTE 3:
The measure of an instrument’s capability to approach a true or absolute value. It is a function of
precision and bias (FDA CDRH).4

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2 Clinical and Laboratory Standards Institute. All rights reserved.
Number 36 AUTO08-A

The Quality System Approach

Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the
development of standards and guidelines, which facilitates project management; defines a document structure via a
template; and provides a process to identify needed documents. The approach is based on the model presented in the
most current edition of CLSI/NCCLS document HS1—A Quality Management System Model for Health Care. The
quality management system approach applies a core set of “quality system essentials” (QSEs), basic to any
organization, to all operations in any healthcare service’s path of workflow (i.e., operational aspects that define how
a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or
service, serving as a manager’s guide. The quality system essentials (QSEs) are:

Documents & Records Equipment Information Management Process Improvement

Organization Purchasing & Inventory Occurrence Management Customer Service
Personnel Process Control Assessments—External Facilities & Safety
and Internal

AUTO08-A addresses the quality system essentials (QSEs) indicated by an “X.” For a description of the other

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documents listed in the grid, please refer to the Related CLSI/NCCLS Publications section on the following page.

Assessments—
Purchasing &

Improvement
Organization

Management

Management
Information

External and

Facilities &
Occurrence
Documents

Equipment
& Records

Personnel

Customer
Inventory

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Process

Process
Control

Service
Internal

Safety
GP19 GP19 GP19 AUTO1 GP19 X AUTO3 GP19 GP19 GP19 GP19
AUTO2 AUTO2 AUTO4
GP19 AUTO3 AUTO5
AUTO4 GP19
AUTO10
GP19
LIS4
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Adapted from CLSI/NCCLS document HS1—A Quality Management System Model for Health Care.

Path of Workflow

A path of workflow is the description of the necessary steps to deliver the particular product or service that the
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organization or entity provides. For example, CLSI/NCCLS document GP26Application of a Quality

Management System Model for Laboratory Services defines a clinical laboratory path of workflow which consists of
three sequential processes: preexamination, examination, and postexamination. All clinical laboratories follow these
processes to deliver the laboratory’s services, namely quality laboratory information.

AUTO08-A addresses the clinical laboratory path of workflow steps indicated by an “X.” For a description of the
other documents listed in the grid, please refer to the Related CLSI/NCCLS Publications section on the following
page.

Preexamination Examination Postexamination

receipt/processing
Sample collection

Results reporting
Sample transport

Results review
and follow-up

and archiving
Interpretation

management
Examination

Examination
ordering

Sample

Sample

X AUTO10 AUTO10 X

Adapted from CLSI/NCCLS document HS1—A Quality Management System Model for Health Care.

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56 Clinical and Laboratory Standards Institute. All rights reserved.
Volume 26 AUTO08-A

Related CLSI/NCCLS Publications*

AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (2000). This
document provides standards for the design and manufacture of specimen containers and carriers used for
collecting and processing liquid samples, such as blood and urine, for clinical testing in laboratory automation
systems.

AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—
Second Edition (2005). This document provides specifications for use of linear bar codes on specimen
container tubes in the clinical laboratory and for use on laboratory automation systems.

AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments,
Devices, and Information Systems; Approved Standard (2000). This document provides standards to
facilitate accurate and timely electronic exchange of data and information between the automated laboratory
elements.

AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information

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Elements; Approved Standard (2001). This document describes operational requirements, characteristics,
and required information elements of clinical laboratory automation systems. This information is used to
determine the status of a clinical specimen within the clinical laboratory automation system, as well as the
status of the actual components of the clinical laboratory automation system.

AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved Standard (2001). This document

AUTO10-A

GP19-A2
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provides standards for the development of an electromechanical interface between instruments and specimen
processing and handling devices used in automated laboratory testing procedures.

Autoverification of Clinical Laboratory Test Results; Approved Guideline (2006). This document
provides a general framework that will allow each laboratory to easily design, implement, validate, and
customize rules for autoverification (automated verification) based on the needs of its own patient population.

Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-
User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition
(2003). This document identifies important factors that designers and laboratory managers should consider
when developing new software-driven systems and selecting software user interfaces. Also included are
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simple rules to help prepare validation protocols for assessing the functionality and dependability of software.

LIS4-A Standard Guide for Documentation of Clinical Laboratory Computer Systems (2003). This guide covers
documentation (defined as the information needed to install, use, maintain, or modify the system) for a
computer system operating in a clinical laboratory.

POCT1-A2 Point-of-Care Connectivity; Approved Standard—Second Edition (2006). This document provides the
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framework for engineers to design devices, work stations, and interfaces that allow multiple types and brands
of point-of-care devices to communicate bidirectionally with access points, data managers, and laboratory
information systems from a variety of vendors.

*
Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process;
therefore, readers should refer to the most current editions.
©
Clinical and Laboratory Standards Institute. All rights reserved. 57
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