April 2009
GP31-A
SA
M
PL
E
Laboratory Instrument Implementation,
Verification, and Maintenance; Approved
Guideline
This guideline provides information about assessing instrument
performance and function from the time of instrument purchase to the
routine performance of clinical testing.
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 clinical 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 clinical laboratory
standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and
global applicability.
Consensus Process
E
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
and accept the resulting agreement.
Commenting on Documents
PL
CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies,
procedures, methods, and protocols affecting the laboratory or health care.
CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as
participants in the reviewing and commenting process. At the end of each comment period, the committee that
developed the document is obligated to review all comments, respond in writing to all substantive comments,
and revise the draft document as appropriate.
Appeals Process
M
Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on
any document. All comments are addressed according to the consensus process by a committee of experts.
SA
If it is believed that an objection has not been adequately addressed, the process for appeals is documented in
the CLSI Standards Development Policies and Process document.
All comments and responses submitted on draft and published documents are retained on file at CLSI and are
available upon request.
Get Involved—Volunteer!
Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get
involved in the revision process? Or maybe you see a need to develop a new document for an emerging
technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and
talents to improve the standards that affect your own work, you will play an active role in improving public
health across the globe.
For further information on committee participation or to submit comments, contact CLSI.
Clinical and Laboratory Standards Institute
950 West Valley Road, Suite 2500
Wayne, PA 19087 USA
P: 610.688.0100
F: 610.688.0700
www.clsi.org
[email protected]
Dear Colleague:
E
Assessing instrument performance is an essential part of the quality program of every laboratory.
Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline
(GP31-A) provides critical information on instrument performance criteria in a systematic and
easy-to-use format.
PL
GP31 is the successor to Laboratory Instrument Evaluation, Verification and Maintenance
Manual, developed by the College of American Pathologists’ Environmental Safety and Health
Resource Committee. Working with the CAP, the Clinical and Laboratory Standards Institute has
published GP31-A as an important addition to the portfolio of standards and guidelines for
laboratory quality. In response to one of CLSI’s overriding organizational goals—achieving
harmonization in its standards and guidelines wherever possible—this guideline has been
harmonized with local and regional requirements, and applicable international standards.
SA
M
CLSI and CAP are pleased to make this guideline available to the patient-testing community as
an important new resource. Future editions of this document will continue to be developed
through CLSI’s consensus process; therefore, users are encouraged to submit comments on the
technical content and applicability of the document. We anticipate that the success of this project
will encourage other organizations to submit broad-based documents for development within the
CLSI consensus process.
Sincerely,
Gerald A. Hoeltge, MD
President
CLSI
Jared N. Schwartz, MD, PhD, FCAP
President
College of American Pathologists
ADVANCING QUALITY IN HEALTH CARE TESTING GP31-A
Vol. 29 No. 11
Replaces GP31-P
Vol. 27 No. 12
ISBN 1-56238-697-2
ISSN 0273-3099
Laboratory Instrument Implementation, Verification, and Maintenance;
Approved Guideline
Volume 29 Number 11
E
PL
Abstract
Jacob (Jack) B. Levine, MBA
Susan T. Martin, MD
Diane M. Pierson, DO
Albert Rabinovitch, MD, PhD
Jennifer Schiffgens, MBA, MT(ASCP), CLS
Jeffrey Seok-Woo Jhang, MD
Delmiro A. Vazquez, MT(ASCP)
M
William J. Castellani, MD
Keith J. Kaplan, MD
John H. Eckfeldt, MD, PhD
David A. Floering, MD
Nathan Gochman, PhD
Gerald A. Hoeltge, MD
Martin Harris Kroll, MD
SA
Clinical and Laboratory Standards Institute document GP31-A—Laboratory Instrument Implementation, Verification, and
Maintenance; Approved Guideline provides recommendations for achieving accurate, precise, and high-quality data for patient
care at a reasonable cost. The guideline includes recommended instrument performance criteria that should be considered;
discussion of proper functioning of instrumentation based on theory or experience, when necessary; and references for further
information. The intent of this guideline is to provide useful information in a systematic and easy-to-use format.
Clinical and Laboratory Standards Institute (CLSI). Laboratory Instrument Implementation, Verification, and Maintenance;
Approved Guideline. CLSI document GP31-A (ISBN 1-56238-697-2). Clinical and Laboratory Standards Institute, 950 West
Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2009.
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 11
GP31-A
Copyright ©2009 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].
E
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
this publication in any other manner, e-mail [email protected].
Suggested Citation
Proposed Guideline
June 2007
Approved Guideline
SA
M
April 2009
PL
CLSI. Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline. CLSI
document GP31-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
ISBN 1-56238-697-2
ISSN 0273-3099
ii
Volume 29
GP31-A
Contents
Abstract ....................................................................................................................................................i Committee Membership........................................................................................................................ iii Foreword .............................................................................................................................................. vii 1 Scope .......................................................................................................................................... 1 2 Introduction ................................................................................................................................ 1 3 Terminology............................................................................................................................... 2 Instrument Implementation and Performance Verification........................................................ 3 5 Instrument Operational Verification and Maintenance Program ............................................... 8 5.1 5.2 5.3 6 Implementation ............................................................................................................. 3 PL
4.1 Recommendations for an Instrument Verification and Maintenance Program ............. 8 Applicable Accreditation and Regulatory Requirements.............................................. 9 Documentation ............................................................................................................ 10 Basic Laboratory Instrumentation............................................................................................ 12 General-Purpose Centrifuges ...................................................................................... 12 Microhematocrit Centrifuges (Dedicated, Fixed RPM) .............................................. 16 Refrigerated Centrifuges ............................................................................................. 17 Pipettors and Dilutors ................................................................................................. 17 Photometry and Other Light-Based Devices .............................................................. 20 Glassware Washers ..................................................................................................... 22 Histology Equipment .................................................................................................. 24 Biological Cabinets and Fume Hoods......................................................................... 28 Osmometers ................................................................................................................ 30 Refractometers ............................................................................................................ 31 Shakers and Rotators .................................................................................................. 33 Temperature-Dependent Equipment ........................................................................... 34 SA
6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 M
4 A Note on Terminology ................................................................................................ 2 Definitions .................................................................................................................... 2 Abbreviations and Acronyms ....................................................................................... 3 E
3.1 3.2 3.3 7 Specialized Laboratory Instrumentation .................................................................................. 38 7.1 7.2 7.3 7.4 7.5 7.6 7.7 Automated Hematology Analyzers ............................................................................. 38 Coagulation Analyzers ................................................................................................ 41 Automated Chemistry Analyzers ................................................................................ 43 Automated Immunoassay Analyzers .......................................................................... 43 Electrode-Based Instruments ...................................................................................... 44 CO-oximeters .............................................................................................................. 46 Flow Cytometry .......................................................................................................... 48 References ............................................................................................................................................. 50 Additional References ........................................................................................................................... 52 Summary of Delegate Comments and Area Committee Responses ..................................................... 53 v
Number 11
GP31-A
Contents (Continued)
The Quality Management System Approach ........................................................................................ 70 SA
M
PL
E
Related CLSI Reference Materials ....................................................................................................... 71 vi
Volume 29
GP31-A
Foreword
Today’s clinical and pathology laboratory is challenged to provide accurate, precise, and high-quality data
for patient care at a reasonable cost. Laboratory directors and managers must make appropriate decisions
in selection of instrumentation. Once those decisions are made, these persons must, with their chosen
instrumentation, adequately and efficiently verify and maintain performance.
Key Words
SA
M
PL
Instrumentation, maintenance, performance verification
E
Many manufacturers and providers of instrumentation offer assistance in selection, as well as
performance verification and maintenance. However, the laboratory director is ultimately responsible for
the quality of the laboratory results. This guideline provides recommendations for instrument
performance criteria, discusses proper functioning based on theory or experience, and references further
information. The intent of this guideline is to provide useful information in a systematic and easy-to-use
format.
vii
Volume 29
GP31-A
Laboratory Instrument Implementation, Verification, and Maintenance;
Approved Guideline
1
Scope
Introduction
PL
2
E
This guideline provides a basic understanding of the considerations for the implementation, verification,
and maintenance of laboratory equipment. Recommendations are generic and not substitutes for specific
information provided by a given instrument’s manufacturer. This guideline discusses general purpose
families of instruments, often adapted by the laboratory for specific tasks, and some area-specific
instruments. It is intended for use by laboratory directors, managers, supervisors, technologists, and
others responsible for routine calibration, verification, maintenance, and operation of laboratory
equipment. Although this guideline is not a textbook of laboratory and pathology equipment, sufficient
background information will be incorporated into the discussion when necessary for understanding the
recommendations provided. This guideline supports activities described in Quality System Essential
(QSE): Equipment.
SA
M
Most results reported by clinical and pathology laboratories are generated by methods using analytical
instruments. Although this guideline will discuss generic instruments, keep two issues in mind. First,
manufacturers of instruments for in vitro diagnostic testing will provide instrument installation,
verification, and maintenance requirements; these requirements must be followed to ensure proper
function. Any additional recommendations in this guideline may supplement, but do not replace,
manufacturers’ requirements. In addition, the reliability of patient results depends on preexamination,
examination, and postexamination factors that include generation of the requisition, preparation of the
patient, sample collection and handling, testing, and reporting results. In order to monitor these factors,
laboratories need a quality assurance program that evaluates each step in laboratory testing and provides
information for maintaining and improving test results for patient care. This guideline describes a quality
assurance program for instruments that evaluates instrument operation and stresses instrument
maintenance. The purpose of performing routine maintenance and operational verification is to isolate the
reasons for instrument-related failure of the testing process and, more importantly, to identify early
instrument malfunction before these changes result in testing failure. This guideline provides information
about assessing instrument performance and function from the time of instrument purchase to the routine
performance of clinical testing.
Instrument verification and maintenance require keeping a wide variety of data that often predict testing
problems and failures. Many problems commonly develop gradually over time, and their effects may be
subtle and not readily detectable in the overall laboratory quality control program during the earlier stages
of degradation. Failure of one component can be detrimental to the overall process and small errors can
result in significant errors when propagated throughout the system. Anticipation of such problems is the
motivation for a comprehensive instrument implementation, verification, and maintenance program.
Instrument and equipment maintenance minimizes the need for expensive repair service and maximizes
the useful life of an instrument. Decreasing instrument breakdown is essential for uninterrupted laboratory
operation, and has an impact on the primary laboratory function of expeditiously providing diagnostically
significant patient test results. Careful instrument and equipment maintenance helps ensure that
instruments will do what is expected of them when results are needed.
Although many sources are available to discuss the basic principles of laboratory and pathology
instrumentation, guidelines that aid in evaluating, verifying, and maintaining this equipment are very rare.
©
Clinical and Laboratory Standards Institute. All rights reserved.
1
Number 11
3
3.1
GP31-A
Terminology
A Note on Terminology
CLSI, as a global leader in standardization, is firmly committed to achieving global harmonization
wherever possible. Harmonization is a process of recognizing, understanding, and explaining differences
while taking steps to achieve worldwide uniformity. CLSI recognizes that medical conventions in the
global metrological community have evolved differently in the United States, Europe, and elsewhere; that
these differences are reflected in CLSI, ISO, and CEN documents; and that legally required use of terms,
regional usage, and different consensus timelines are all important considerations in the harmonization
process. In light of this, CLSI’s consensus process for development and revision of standards focuses on
harmonization of terms to facilitate the global application of standards.
3.2
Definitions
PL
E
In order to align the usage of terminology in this document with that of ISO, the term sample replaces the
term specimen. The users of this guideline should understand that the fundamental meanings of the terms
are identical in many cases, and are defined in the guideline’s Definitions section (see Section 3.2). The
terms in this document are consistent with those defined in the ISO 15189 and ISO 9000 series of
standards.
accuracy (measurement) – closeness of agreement between a measured quantity value and a true
quantity value of the measurand (VIM07).1
M
calibration verification – the assaying of calibration materials in the same manner as patient samples to
confirm that the calibration of the instrument, kit, or test system has remained stable throughout the
measurement range for patient test results.
clinical laboratory reagent water – water pure enough to satisfy the requirements of most clinical
laboratory testing, as specified in CLSI document C03.2
SA
examination – set of operations having the object of determining the value or characteristics of a property
(ISO 15189)3; NOTE 1: In some countries and disciplines (eg, microbiology), an examination is the total
activity of a number of tests, observations, or measurements (ISO 15189); NOTE 2: For the purposes of
this guideline, readers can consider the terms “examination” and “test” to be equivalent.
interference – artifactual increase or decrease in apparent concentration or intensity of an analyte due to
the presence of a substance that reacts nonspecifically with either the detecting reagent or the signal itself.
measurand – quantity intended to be measured (VIM07); NOTE: Do not use the term parameter as a
synonym for measurand.
performance characteristics – the set of expected criteria that the instrument is validated to meet when
used appropriately.
precision (of measurement) – the closeness of agreement between independent test results obtained
under stipulated conditions (ISO 3534-1)4; NOTE: Precision is not typically represented as a numerical
value but is expressed quantitatively in terms of imprecision—the standard deviation (SD) or the
coefficient of variation (%CV) of the results in a set of replicate measurements.
sensitivity (of a measuring system) – quotient of the change in an indication of a measuring system and
the corresponding change in a value of a quantity being measured (VIM07)5; NOTE 1: Sensitivity of a
2
©
Clinical and Laboratory Standards Institute. All rights reserved.
Number 11
GP31-A
The Quality Management System Approach
Clinical and Laboratory Standards Institute 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 HS01—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 health care service’s path of workflow (ie, 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 QSEs are:
Documents & Records
Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
Information Management
Occurrence Management
Assessments―External &
Internal
Process Improvement
Customer Service
Facilities & Safety
Facilities &
Safety
Customer
Service
E
Process
Improvement
Assessments
—External &
Internal
Occurrence
Management
Information
Management
PL
X
Process
Control
Purchasing &
Inventory
Equipment
Personnel
Organization
Documents
& Records
GP31-A addresses the QSEs indicated by an “X.” For a description of the other documents listed in the grid, please
refer to the Related CLSI Reference Materials section on the following page.
C03
C46
EP05
EP21
HS04
HS04
HS04
HS04
HS03
HS04
M29
M
HS04
HS04
HS04
HS04
HS04
GP17
GP18
HS04
HS04
M29
Adapted from CLSI/NCCLS document HS01—A Quality Management System Model for Health Care.
Path of Workflow
SA
A path of workflow is the description of the necessary steps to deliver the particular product or service that the
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.
GP31-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 Reference Materials section on the following page.
C46
H07
C46
H07
C46
Sample
management
C46
H07
Results reporting
and archiving
Examination
Sample
receipt/processing
Sample transport
C46
Postexamination
Interpretation
C46
Examination
Results review
and follow-up
C46
Sample collection
Examination
ordering
Preexamination
C46
Adapted from CLSI/NCCLS document HS01—A Quality Management System Model for Health Care.
70
©
Clinical and Laboratory Standards Institute. All rights reserved.
Volume 29
GP31-A
Related CLSI Reference Materials*
C03-A4
Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth
Edition (2006). This document provides guidelines on water purified for clinical laboratory use; methods for
monitoring water quality and testing for specific contaminants; and water system design considerations.
C46-A2
Blood Gas and pH Analysis and Related Measurements; Approved Guideline—Second Edition (2009).
American National Standard. This document provides clear definitions of the quantities in current use, and
provides a single source of information on appropriate specimen collection, preanalytical variables,
calibration, and quality control for blood pH and gas analysis and related measurements.
EP05-A2
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved
Second Edition (2004). This document provides guidance for designing an experiment to
precision performance of quantitative measurement methods; recommendations on comparing
precision estimates with manufacturers’ precision performance claims and determining
comparisons are valid; as well as manufacturers’ guidelines for establishing claims.
EP21-A
Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (2003).
This document provides manufacturers and end users with a means to estimate total analytical error for an
assay. A data collection protocol and an analysis method that can be used to judge the clinical acceptability of
new methods using patient specimens are included. These tools can also monitor an assay’s total analytical
error by using quality control samples.
GP17-A2
Clinical Laboratory Safety; Approved Guideline⎯Second Edition (2004). This document contains general
recommendations for implementing a high-quality laboratory safety program, which are provided in a
framework that is adaptable within any laboratory.
GP18-A2
Laboratory Design; Approved Guideline—Second Edition (2007). This document provides a foundation of
information about laboratory design elements and guidance to help define the issues to be considered when
designing a clinical laboratory.
H07-A3
Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved
Standard—Third Edition (2000). This document describes a standard microhematocrit method for
determining packed cell volume; specifications for recommended materials and information on potential
sources of error are also included.
HS03-A
Pulse Oximetry; Approved Guideline (2005). Pulse oximetry is a widely used device for the clinical
assessment of arterial oxygenation and pulse rate. The clinical applications, quality assessment, and limitations
are discussed in this guideline.
HS04-A2
Application of a Quality Management System Model for Respiratory Services; Approved Guideline—
Second Edition (2006). This guideline describes the respiratory services path of workflow and provides
information for respiratory services operations that will assist the services in improving their processes and
meeting government and accreditation requirements.
M29-A3
Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—
Third Edition (2005). Based on US regulations, this document provides guidance on the risk of transmission
of infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific
precautions for preventing the laboratory transmission of microbial infection from laboratory instruments and
materials; and recommendations for the management of exposure to infectious agents.
SA
M
PL
E
Guideline—
evaluate the
the resulting
when such
*
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.
71
PL
As we continue to set the global standard
for quality in laboratory testing, we’re
adding initiatives to bring even more
value to our members and customers.
E
Explore the Latest
Offerings from CLSI!
Power Forward
with this Official
Interactive Guide
Fundamentals for implementing
a quality management system
in the clinical laboratory.
The value of a CLSI membership begins with significant discounts—
up to 70% off—on our trusted clinical laboratory standards and
guidelines, but the benefits extend far beyond cost savings:
Benefits to Industry
Contribute to Standards that Streamline Product Review Processes
Access a Deep Network of Customers, Peers, Regulators, and Industry Leaders
Raise Your Organization’s Profile in the Clinical Laboratory Community
Benefits to Laboratories
Directly Influence CLSI Standards to Ensure they are Practical and Achievable
Access Globally Recognized Standards for Accreditation Preparedness
Help Drive Higher Levels of Patient Care Quality All Over the World
Benefits to Government
Aid in the Development of Consensus Standards that can Impact Legislation
Connect with Over 2,000 Influential Organizations Across the Global Laboratory Community
Help Laboratories Provide Safe and Effective Care of the Highest Quality and Value
www.clsi.org/membership
About CLSI
M
The Clinical and Laboratory Standards Institute
Visit the CLSI U
Education Center
SA
Where we provide the convenient
and cost-effective education
resources that laboratories
need to put CLSI standards into
practice, including webinars,
workshops, and more.
Shop Our Online
Products
e CLIPSE
TM
Ultimate Access
Including eCLIPSE Ultimate
Access™, CLSI’s cloud-based,
online portal that makes it easy
to access our standards and
guidelines—anytime, anywhere.
Introducing CLSI’s
New Membership
Opportunities
(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 clinical standards and guidelines
950 West Valley Road, Suite 2500, Wayne, PA 19087
P: 610.688.0100 Toll Free (US): 877.447.1888
F: 610.688.0700 E: [email protected]
that help laboratories fulfill their responsibilities
with efficiency, effectiveness, and global applicability.
More Options. More Benefits. More Value.
Join in Our Mission to Improve
Health Care Outcomes
We’ve made it even easier for your organization to take
full advantage of the standards resources and networking
opportunities available through membership with CLSI.
Find Membership
Opportunities
See the options that make it even
easier for your organization to take
full advantage of CLSI benefits and
our unique membership value.
For more information, visit
www.clsi.org today.
E
PL
M
SA
950 West Valley Road, Suite 2500, Wayne, PA 19087 USA
P: 610.688.0100 Toll Free (US): 877.447.1888 F: 610.688.0700
E: [email protected] www.clsi.org
ISBN 1-56238-697-2