Clsi Auto4 A

AUTO4-A Replaces AUTO4-P
Vol. 21 No. 4 Vol. 19 No. 22

Laboratory Automation: Systems Operational Requirements,
Characteristics, and Information Elements; Approved Standard
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.
A standard for global application developed through the NCCLS consensus process.
Acknowledgements
NCCLS gratefully acknowledges the following sponsors of this project:
American Association for Clinical Chemistry (AACC) Labotix
American Society for Clinical Laboratory Science Medical Laboratory Automation, Inc.
(ASCLS)
Methodist Hospitals of Memphis Lab
A & T Corporation
Michigan Department of Community Health
Abbott Diagnostics
Microscan
ARUP Laboratories
NCSU College of Veterinary Medicine
Auto Lab Systems
NIST/Analytical Chemistry CSTL
Bayer Diagnostics
National Academy of Clinical Biochemistry
Beckman Coulter Corporation
Olympus, Inc.
Becton Dickinson and Company
Ortho-Clinical Diagnostics
Children’s Hospital Medical Center (Cincinnati, OH) A Johnson & Johnson company
Chiron Diagnostics Corporation Pharmacia & Upjohn
Clinical Laboratory Management Association (CLMA) Quest Diagnostics
College of American Pathologists (CAP) Roche Diagnostics, Inc.
Compunet Clinical Labs SMS
CRS Robotics Sanofi Pasteur Diagnostics
Dade Behring Inc. SmithKline Beecham Clinical Labs
Dean Medical Center Sysmex Corporation (TOA)
Duke University Tecan
Enterprise Analysis Corporation Trillium GmbH
Food and Drug Administration (FDA) Triple G Corporation
HBO & Company UMD of New Jersey University Hospital
Hartford Hospital University Hospitals Lab Services Foundation
Hitachi Instruments, Inc. University of Nebraska Medical Center
Kaiser Permanente Wuesthoff Health Systems
Konelab Corporation Wellmont Health Systems
LAB-InterLink York Hospital

Volume 21 AUTO4-A

Abstract
NCCLS document AUTO4-A—Laboratory Automation: Systems Operational Requirements,

Characteristics, and Information Elements; Approved Standard defines operational requirements,
characteristics, and required information elements of clinical laboratory automation systems to support
continuous, uninterrupted operation with appropriate human intervention. The standard is divided into
two parts. The first part of this document was developed to serve as a standard describing elements which
will facilitate the rapid determination of the status of a clinical specimen within a clinical laboratory
automation system. The second part of this document was developed to serve as a standard describing
elements which will facilitate the rapid determination of the status of the components of a clinical
laboratory automation system.
NCCLS. Laboratory Automation: Systems Operational Requirements, Characteristics, and Information

Elements; Approved Standard. NCCLS document AUTO4-A (ISBN 1-56238-431-7). NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001
THE NCCLS consensus process, which is the mechanism for moving a document through two or more
levels of review by the healthcare 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 NCCLS documents. Current editions are listed in the NCCLS Catalog, which is
distributed to member organizations, and to nonmembers on request. If your organization is not a
member and would like to become one, and to request a copy of the NCCLS Catalog, contact the
NCCLS Executive Offices. Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: exoffice@nccls.org;
Website: www.nccls.org
i
Number 4 NCCLS
ii
AUTO4-A
ISBN 1-56238-431-7
ISSN 0273-3099
Volume 21 Number 4
Russell H. Tomar, M.D., Chairholder
Raymond D. Aller, M.D., Vice-Chairholder
Charles F. Arkin, M.D.
John F. Boje
Andrzej J. Knafel, Ph.D.
Kam Lo, Ph.D.
Ryuji Tao
Number 4 NCCLS
This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system,
transmitted, or made available in any form or by any means (electronic, mechanical, photocopying,
recording, or otherwise) without prior written permission from NCCLS, except as stated below.
NCCLS hereby grants permission to reproduce limited portions of this publication for use in laboratory
procedure manuals at a single site, for interlibrary loan, or for use in educational programs provided that
multiple copies of such reproduction shall include the following notice, be distributed without charge,
and, in no event, contain more than 20% of the document’s text.
Reproduced with permission, from NCCLS publication AUTO4-A—Laboratory

Automation: Systems Operational Requirements, Characteristics, and Information
Elements; Approved Standard (ISBN 1-56238-431-7). Copies of the current edition may
be obtained from NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898, USA.
Permission to reproduce or otherwise use the text of this document to an extent that exceeds the
exemptions granted here or under the Copyright Law must be obtained from NCCLS by written request.
To request such permission, address inquiries to the Executive Director, NCCLS, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898, USA.
Copyright ©2001. The National Committee for Clinical Laboratory Standards.
Suggested Citation
(NCCLS. Laboratory Automation: Systems Operational Requirements, Characteristics, and Information

Elements; Approved Standard. NCCLS document AUTO4-A [ISBN 1-56238-431-7]. NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001.)
Proposed Standard
October 1999
Approved Standard
March 2001
ISBN 1-56238-431-7
ISSN 0273-3099
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Volume 21 AUTO4-A
Committee Membership
Area Committee on Automation
Rodney S. Markin, M.D., Ph.D. University of Nebraska Medical Center

Chairholder Omaha, Nebraska
Paul J. Mountain, M.Sc., M.T.(ASCP) MDS Laboratories

Vice-Chairholder Etobicoke, Ontario Canada
Subcommittee on System Status
Russell H. Tomar, M.D. Cook County Hospital

Chairholder Chicago, Illinois
Raymond D. Aller, M.D. MDS Lab Services (US)

Vice-Chairholder Nashville, Tennessee
Charles F. Arkin, M.D. Boston University Medical Center

Boston, Massachusetts
John F. Boje LAB-InterLink, Inc.

Omaha, Nebraska
Andrzej J. Knafel, Ph.D. Roche Diagnostics

Rotkreuz, Switzerland
James E. Myrick, Ph.D. Centers for Disease Control and Prevention

Atlanta, Georgia
Jutaro Tadano, M.D., Ph.D. Saga Medical School

Saga, Japan
Ryuji Tao Hitachi, Ltd. Instruments

Ibaraki-ken, Japan
Advisors
Michael G. Bissell, M.D., Ph.D. Ohio State University

Columbus, Ohio
Martin Burri Roche Diagnostics

Rotkreuz, Switzerland
James Callaghan FDA Ctr. for Devices/Rad. Health

Gaithersburg, Maryland
Michael Campanelli Bayer Corporation

Tarrytown, New York
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Number 4 NCCLS
Advisors (Continued)
Alex Ciraco MDS Autolab

Etobicoke, Ontario Canada
Natalie Ortoli Drew, M.T.(ASCP) Yale New Haven Hospital

New Haven, Connecticut
Jane du Preez A.I. Scientific

Scarborough, Australia
Charles D. Hawker, Ph.D. ARUP Laboratories, Inc.

Salt Lake City, Utah
Masayoshi Hayashi Sysmex Corporation

Kobe, Japan
Hendrik J. Keesom Ortho-Clinical Diagnostics

Rochester, New York
Brad Kowalski Marshfield Laboratories

Marshfield, Wisconsin
Gary W. Kramer, Ph.D. National Institute of Stds. & Technology

Gaithersburg, Maryland
Kam Lo Abbott Laboratories

Abbott Park, Illinois
John C. Mazza Dade Behring Inc.

Newark, Delaware
David O'Bryan, Ph.D. Hibernia Consulting

Kennett Square, Pennsylvania
Willem Stokdijk BD Immunocytometry Systems

San Jose, California
Stuart D. Wills Beckman Coulter, Inc.

Miami, Florida
Charles F. Galanaugh Becton Dickinson and Company (Retired)

Special Liaison West Milford, New Jersey
Marc R. Schlank, M.T.(ASCP), M.S. NCCLS

Staff Liaison Wayne, Pennsylvania
Patrice E. Polgar NCCLS

Editor Wayne, Pennsylvania
Donna M. Wilhelm NCCLS

Assistant Editor Wayne, Pennsylvania
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Volume 21 AUTO4-A
Active Membership
(as of 1 January 2001)
Sustaining Members Canadian Society for Medical Chinese Committee for Clinical
Laboratory Science—Société Laboratory Standards
Abbott Laboratories Canadienne de Science de Commonwealth of Pennsylvania
American Association for Laboratoire Médical Bureau of Laboratories
Clinical Chemistry Canadian Society of Clinical Department of Veterans Affairs
Bayer Corporation Chemists Deutsches Institut für Normung
Beckman Coulter, Inc. Clinical Laboratory Management (DIN)
BD and Company Association FDA Center for Devices and
bioMérieux, Inc. COLA Radiological Health
College of American Pathologists College of American Pathologists FDA Center for Veterinary
Dade Behring Inc. College of Medical Laboratory Medicine
Nippon Becton Dickinson Co., Ltd. Technologists of Ontario FDA Division of Anti-Infective
Ortho-Clinical Diagnostics, Inc. College of Physicians and Drug Products
Pfizer Inc Surgeons of Saskatchewan Health Care Financing
Roche Diagnostics, Inc. Fundación Bioquímica Argentina Administration/CLIA Program
SmithKline Beecham International Association of Medical Health Care Financing
Pharmaceuticals Laboratory Technologists Administration
International Council for Iowa State Hygienic Laboratory
Professional Members Standardization in Haematology Massachusetts Department of
International Federation of Public Health Laboratories
American Academy of Family Clinical Chemistry National Association of Testing
Physicians Italian Society of Clinical Authorities – Australia
American Association of Blood Biochemistry National Center of Infectious
Banks Japan Society of Clinical Chemistry and Parasitic Diseases (Bulgaria)
American Association for Japanese Association of Medical National Institute of Standards
Clinical Chemistry Technologists (Tokyo) and Technology
American Association for Japanese Committee for Clinical Ohio Department of Health
Respiratory Care Laboratory Standards Ontario Minis try of Health
American Chemical Society Joint Commission on Accreditation Saskatchewan Health-Provincial
American Medical Technologists of Healthcare Organizations Laboratory
American Public Health Association National Academy of Clinical Scientific Institute of Public Health;
American Society for Clinical Biochemistry Belgium Ministry of Social
Laboratory Science National Society for Affairs, Public Health and the
American Society of Hematology Histotechnology, Inc. Environment
American Society for Microbiology Ontario Medical Association South African Institute for Medical
American Society of Quality Management Program- Research
Parasitologists, Inc. Laboratory Service Swedish Institute for Infectious
American Type Culture RCPA Quality Assurance Programs Disease Control
Collection, Inc. PTY Limited Thailand Department of Medical
Asociacion de Laboratorios de Alta Sociedade Brasileira de Analises Sciences
Complejidad Clinicas
Asociación Española Primera de Sociedade Brasileira de Industry Members
Socorros (Uruguay) Patologia Clinica
Asociacion Mexicana de Sociedad Espanola de Quimica AB Biodisk
Bioquimica Clinica A.C. Clinica Abbott Laboratories
Assn. of Public Health Laboratories Abbott Laboratories, MediSense
Assoc. Micro. Clinici Italiani- Government Members Products
A.M.C.L.I. Accumetrics, Inc.
Australasian Association of Association of Public Health Agilent Technologies, Inc.
Clinical Biochemists Laboratories Ammirati Regulatory Consulting
British Society for Antimicrobial Armed Forces Institute of Pathology Asséssor
Chemotherapy BC Centre for Disease Control AstraZeneca
Centers for Disease Control and Aventis
Prevention Avocet Medical, Inc.
Bayer Corporation – Elkhart, IN
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Number 4 NCCLS
Bayer Corporation – Middletown, Instrumentation Laboratory Sysmex Corporation (Japan)

VA International Technidyne Sysmex Corporation
Bayer Corporation – Tarrytown, NY Corporation (Long Grove, IL)
Bayer Corporation – West Haven, Kendall Sherwood-Davis & Geck The Toledo Hospital (OH)
CT Labtest Diagnostica S.A. Trek Diagnostic Systems, Inc.
Bayer Medical Ltd. LifeScan, Inc. (a Johnson & Vetoquinol S.A.
BD Johnson Company) Visible Genetics, Inc.
BD Biosciences – San Jose, CA Lilly Research Laboratories Vysis, Inc.
BD Biosciences – Sparks, MD Medical Automation Systems Wallac Oy
BD Consumer Products Medical Device Consultants, Inc. Wyeth-Ayerst
BD Italia S.P.A. Medical Laboratory Automation Xyletech Systems, Inc.
BD VACUTAINER Systems Inc. YD Consultant
Beckman Coulter, Inc. Medtronic, Inc. Yeongdong Pharmaceutical
Beckman Coulter, Inc. Primary Care Merck & Company, Inc. Corporation
Diagnostics mvi Sciences (MA)
Beckman Coulter K.K. (Japan) Nabi Trade Associations
Bio-Development SRL Neometrics is.
Bio-Inova Life Sciences Nichols Institute Diagnostics AdvaMed
International (Div. of Quest Diagnostics, Inc.) Association of Medical
BioMedia Laboratories Sdn Bhd Nissui Pharmaceutical Co., Ltd. Diagnostic Manufacturers
bioMérieux, Inc. Nippon Becton Dickinson Co., Ltd. Japan Association Clinical
Biometrology Consultants Norfolk Associates, Inc. Reagents Ind. (Tokyo, Japan)
Bio-Rad Laboratories, Inc. Organon Teknika Corporation Medical Industry Association
Biotest AG Ortho-Clinical Diagnostics, Inc. of Australia
Bristol-Myers Squibb Company (Raritan, NJ)
Canadian External Quality Ortho-Clinical Diagnostics, Inc. Associate Active Members
Assessment Laboratory (Rochester, NY)
Capital Management Consulting, Oxoid Inc. 20th Medical Group (SC)
Inc. Pfizer Inc 67th CSH Wuerzburg, GE (NY)
Checkpoint Development Inc. Pharmacia & Upjohn 121st General Hospital (CA)
Clinical Design Group Inc. Premier Inc. Academisch Ziekenhuis -VUB
COBE Laboratories, Inc. Procter & Gamble (Belgium)
Combact Diagnostic Systems Ltd. Pharmaceuticals, Inc. Acadiana Medical Laboratories,
Community Medical Center (NJ) The Product Development Group LTD (LA)
Control Lab (Brazil) Quintiles, Inc. Adena Regional Medical Center
Copan Diagnostics Inc. Radiometer America, Inc. (OH)
Cosmetic Ingredient Review Radiometer Medical A/S Advocate Laboratories (IL)
Cubist Pharmaceuticals David G. Rhoads Associates, Inc. The Aga Khan Hospital & Medical
Cytometrics, Inc. Roche Diagnostics GmbH College, Karachi (Pakistan)
Dade Behring Inc. - Deerfield, IL Roche Diagnostics, Inc. Albany Medical Center Hospital
Dade Behring Inc. - Glasgow, DE Roche Laboratories (Div. (NY)
Dade Behring Inc. - Marburg, Hoffmann-La Roche Inc.) Albemarle Hospital (NC)
Germany The R.W. Johnson Allegheny General Hospital (PA)
Dade Behring Inc. - Sacramento, CA Pharmaceutical Research Institute Allegheny University of the
Dade Behring Inc. - San Jose, CA Sanofi Diagnostics Pasteur Health Sciences (PA)
DAKO A/S Sarstedt, Inc. Allina Laboratories (MN)
Diagnostic Products Corporation SARL Laboratoire Carron (France) Alton Ochsner Medical
Eiken Chemical Company, Ltd. Schering Corporation Foundation (LA)
Enterprise Analysis Corporation Schleicher & Schuell, Inc. American Medical Laboratories
Fort Dodge Animal Health Second Opinion (VA)
General Hospital Vienna (Austria) SenDx Medical, Inc. Anzac House (Australia)
Gen-Probe Showa Yakuhin Kako Company, Arkansas Department of Health
Glaxo-Wellcome, Inc. Ltd. Armed Forces Research Institute of
Greiner Meditech, Inc. SmithKline Beecham Medical Science (APO, AP)
Health Systems Concepts, Inc. Pharmaceuticals Associated Regional &
Helena Laboratories SmithKline Beecham, S.A. University Pathologists (UT)
Home Diagnostics, Inc. Streck Laboratories, Inc. Aurora Consolidated
I-STAT Corporation SurroMed, Inc. Laboratories (WI)
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Volume 21 AUTO4-A
Bay Medical Center (MI) Diagnostic Laboratory Services, Hotel Dieu Hospital (Windsor, ON,
Baystate Medical Center (MA) Inc. (HI) Canada)
Bonnyville Health Center (Alberta, Duke University Medical Center Huddinge University Hospital
Canada) (NC) (Sweden)
Boulder Community Hospital (CO) Durham Regional Hospital (NC) Hurley Medical Center (MI)
Brantford General Hospital Duzen Laboratories (Turkey) Indiana State Board of Health
(Ontario, Canada) Dynacare Laboratories - Eastern Indiana University
Brazileiro De Promocao (Brazil) Region (Ottawa, ON, Canada) Instituto Scientifico HS. Raffaele
Brookdale Hospital Medical Dynacare Memorial Hermann (Italy)
Center (NY) Laboratory Services (TX) International Health Management
Brooke Army Medical Center (TX) E.A. Conway Medical Center (LA) Associates, Inc. (IL)
Brooks Air Force Base (TX) Eastern Maine Medical Center Jersey Shore Medical Center (NJ)
Broward General Medical Center East Side Clinical Laboratory (RI) Joel T. Boone Branch Medical Clinic
(FL) Elyria Memorial Hospital (OH) (VA)
Calgary Laboratory Services Emory University Hospital (GA) John C. Lincoln Hospital (AZ)
Carilion Consolidated Laboratory Esoterix Center for Infectious John Peter Smith Hospital (TX)
(VA) Disease (TX) John Randolph Hospital (VA)
CB Healthcare Complex Fairfax Hospital (VA) Kaiser Permanente (CA)
(Sydney, NS, Canada) Fairview-University Medical Kaiser Permanente (MD)
Central Kansas Medical Center Center (MN) Kantousspital (Switzerland)
Centralized Laboratory Services Foothills Hospital (Calgary, AB, Kenora-Rainy River Regional
(NY) Canada) Laboratory Program (Ontario,
Centro Diagnostico Italiano Fort St. John General Hospital Canada)
(Milano, Italy) (Fort St. John, BC, Canada) Kern Medical Center (CA)
Champlain Valley Physicians Fox Chase Cancer Center (PA) King Fahad National Guard
Hospital (NY) Franklin Square Hospital Center Hospital (Saudi Arabia)
Chang Gung Memorial Hospital (MD) Kings County Hospital Center (NY)
(Taiwan) Fresenius Medical Care/Life Chem Klinicni Center (Slovenia)
Children’s Hospital (LA) (NJ) LabCorp (NC)
Children’s Hospital (NE) Fresno Community Hospital and Laboratoire de Santé Publique
Children’s Hospital & Clinics (MN) Medical Center du Quebec (Canada)
Children’s Hospital King's Gambro Healthcare Laboratory Laboratories at Bonfils (CO)
Daughters (VA) (FL) Laboratório Fleury S/C Ltda.
Children’s Hospital Medical Center GDS Technology, Inc (IN) (Brazil)
(Akron, OH) Geisinger Medical Center (PA) Laboratory Corporation of
Children’s Hospital of Grady Memorial Hospital (GA) America (MO)
Philadelphia (PA) Guthrie Clinic Laboratories (PA) LAC and USC Healthcare
Clarian Health–Methodist Hospital Harris Methodist Fort Worth (TX) Network (CA)
(IN) Harris Methodist Northwest (TX) Lakeland Regional Medical Center
Clendo Lab (Puerto Rico) Hartford Hospital (CT) (FL)
CLSI Laboratories (PA) Headwaters Health Authority Lancaster General Hospital (PA)
Columbus County Hospital (NC) (Alberta, Canada) Langley Air Force Base (VA)
Commonwealth of Kentucky Health Alliance Laboratory (OH) LeBonheur Children’s
CompuNet Clinical Laboratories Health Network Lab (PA) Medical Center (TN)
(OH) Health Sciences Centre Lewis -Gale Medical Center (VA)
Covance Central Laboratory (Winnipeg, MB, Canada) Libero Instituto Univ. Campus
Services (IN) Heartland Health System (MO) BioMedico (Italy)
Danish Veterinary Laboratory Hoag Memo rial Hospital Licking Memorial Hospital (OH)
(Copenhagen, Denmark) Presbyterian (CA) Louisiana State University
Danville Regional Medical Center Holmes Regional Medical Center Medical Center
(VA) (FL) Magee Womens Hospital (PA)
Deaconess Hospital (MO) Holy Spirit Hospital (PA) Magnolia Regional Health Center
Dean Medical Center (WI) Holzer Medical Center (OH) (MS)
Delaware Public Health Laboratory Hospital for Sick Children Martin Luther King/Drew Medical
Department of Health & Community (Toronto, ON, Canada) Center (CA)
Services (New Brunswick, Canada) Hospital Israelita Albert Einstein Massachusetts General Hospital
Detroit Health Department (MI) (Brazil) (Microbiology Laboratory)
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Number 4 NCCLS
Massachusetts General Hospital Ohio Valley Medical Center (WV) St. Alexius Medical Center (ND)
(Pathology Laboratory) Olin E. Teague Medical Center St. Anthony Hospital (CO)
Mayo Clinic Scottsdale (AZ) (TX) St. Barnabas Medical Center (NJ)
MDS Metro Laboratory Services O.L. Vrouwziekenhuis (Belgium) St. Boniface General Hospital
(Burnaby, BC, Canada) Ordre professionnel des (Winnipeg, Canada)
Medical College of Virginia technologists médicaux du St. Elizabeth Hospital (NJ)
Hospital Québec St. John Hospital and Medical
Medicare/Medicaid Certification, Ospedali Riuniti (Italy) Center (MI)
State of North Carolina The Ottawa Hospital St. John Regional Hospital (St.
Memorial Hospital (CO) (Ottawa, ON, Canada) John, NB, Canada)
Memorial Medical Center Our Lady of Lourdes Hospital (NJ) St. Joseph Hospital (NE)
(Napoleon Ave., New Orleans, LA) Our Lady of the Resurrection St. Joseph Mercy – Oakland (MI)
Memorial Medical Center Medical Center (IL) St. Joseph’s Hospital – Marshfield
(N. Jefferson Davis Pkwy., Pathology and Cytology Clinic (WI)
New Orleans, LA) Laboratories, Inc. (KY) St. Luke’s Hospital (PA)
Memorial Medical Center (IL) Pathology Associates Laboratories St. Luke’s Regional Medical
Mercy Health System (PA) (CA) Center (IA)
Mercy Hospital (NC) The Permanente Medical Group St. Mary Medical Center (IN)
Mercy Medical Center (CA) St. Mary of the Plains Hospital
Des Moines (IA) Pocono Hospital (PA) (TX)
Mescalero Indian Hospital (NM) Our Lady of Lourdes Hospital (NJ) St. Mary’s Hospital & Medical
Methodist Hospitals of Memphis Our Lady of the Resurrection Center (CO)
(TN) Medical Center (IL) Ste. Justine Hospital (Montreal, PQ,
Michigan Department of Pathology and Cytology Canada)
Community Health Laboratories, Inc. (KY) Salina Regional Health Center (KS)
Mississippi Baptist Medical Center Pathology Associates Laboratories San Francisco General Hospital
Monte Tabor – Centro Italo - (CA) (CA)
Brazileiro de Promocao (Brazil) The Permanente Medical Group Santa Cabrini Hospital
Montreal Children’s Hospital (CA) (Montreal, PQ Canada)
(Canada) Pocono Hospital (PA) Santa Clara Valley Medical Center
Montreal General Hospital Presbyterian Hospital (NC) (CA)
(Canada) Presbyterian Hospital of Dallas Seoul Nat’l University Hospital
Morton Plant Mease Health Care (TX) (Korea)
(FL) Prodia Clinical Laboratory Shanghai Center for the
Mount Sinai Hospital (NY) (Indonesia) Clinical Laboratory (China)
Mount Sinai Medical Center (FL) Providence Health System (OR) Shands Healthcare (FL)
MRL Reference Laboratory (CA) Providence Seattle Medical Center SmithKline Beecham Clinical
National University Hospital (WA) Laboratories (GA)
(Singapore) Queen Elizabeth Hospital (Prince South Bend Medical Foundation
Naval Surface Warfare Center (IN) Edward Island, Canada) (IN)
New Britain General Hospital (CT) Queensland Health Pathology Southern California Permanente
New England Fertility Institute (CT) Serv ices (Australia) Medical Group
New England Medical Center Quest Diagnostics, Incorporated South Western Area Pathology
Hospital (MA) (AZ) Service (Australia)
New York Hospital Medical Center Quest Diagnostics Incorporated Speciality Laboratories, Inc. (CA)
of Queens (CA) Stanford Hospital and Clinics (CA)
New York State Department of Quintiles Laboratories, Ltd. (GA) State of Washington Department of
Health Regions Hospital Health
NorDx (ME) Research Medical Center (MO) Stormont-Vail Regional Medical
North Carolina Laboratory of Rex Healthcare (NC) Center (KS)
Public Health Rhode Island Department of Health Sun Health-Boswell Hospital (AZ)
North Mississippi Medical Center Laboratories Sunrise Hospital and Medical
North Shore – Long Island Jewish Riyadh Armed Forces Hospital Center (NV)
Health System Laboratories (NY) (Saudi Arabia) Tenet Odessa Regional Hospital (TX)
Northridge Hospital Medical Royal Columbian Hospital (New Touro Infirmary (LA)
Center (CA) Westminster, BC, Canada) Tri-City Medical Center (CA)
Northwestern Memorial Hospital Saint Mary’s Regional Medical Trident Regional Medical Center
(IL) Center (NV) (SC)
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Volume 21 AUTO4-A
Tripler Army Medical Center (HI) University of Virginia Medical Viridae Clinical Sciences, Inc.
Truman Medical Center (MO) Center (Vancouver, BC, Canada)
UCSF Medical Center (CA) University of Washington Warde Medical Laboratory (MI)
UNC Hospitals (NC) UPMC Bedford Memorial (PA) Washoe Medical Center Laboratory
The University Hospitals (OK) UZ-KUL Medical Center (Belgium) (NV)
Unilab Clinical Laboratories (CA) VA (Dayton) Medical Center (OH) Watson Clinic (FL)
University Hospital (Gent) VA (Denver) Medical Center (CO) Wilford Hall Medical Center (TX)
(Belgium) VA (Kansas City) Medical Center William Beaumont Hospital (MI)
University Hospital (TX) (MO) Williamsburg Community Hospital
University of Alberta Hospitals VA (Martinez) Medical Center (VA)
(Canada) (CA) Winn Army Community Hospital
University of Chicago Hospitals (IL) VA (San Diego) Medical Center (GA)
University of Florida (CA) Wishard Memorial Hospital (IN)
University of Medicine & Dentistry, VA (Tuskegee) Medical Center Yan Chai Hospital (P.R. China)
NJ University Hospital (AL) Yonsei University College of
University of the Ryukyus (Japan) VA Outpatient Clinic (OH) Medicine (Korea)
University of Texas M.D. Anderson Vejle Hospital (Denmark) York Hospital (PA)
Cancer Center Virginia Department of Health Zale Lipshy University Hospital
(TX)
OFFICERS BOARD OF DIRECTORS
F. Alan Andersen, Ph.D., Susan Blonshine, RRT, RPFT, Tadashi Kawai, M.D., Ph.D.
President FAARC International Clinical Pathology
Cosmetic Ingredient Review TechEd Center
Donna M. Meyer, Ph.D., Kurt H. Davis, FCSMLS, CAE J. Stephen Kroger, M.D., FACP
President Elect Canadian Society for Medical COLA
CHRISTUS Health Laboratory Science
Barbara G. Painter, Ph.D.
Robert F. Moran, Ph.D., FCCM, Robert L. Habig, Ph.D. Bayer Corporation
FAIC Cytometrics, Inc.
Secretary Emil Voelkert, Ph.D.
mvi Sciences Thomas L. Hearn, Ph.D. Roche Diagnostics GmbH
Centers for Disease Control and
Gerald A. Hoeltge, M.D. Prevention Ann M. Willey, Ph.D., J.D.
Treasurer New York State Department of
The Cleveland Clinic Foundation Elizabeth D. Jacobson, Ph.D. Health
Food and Drug Administration
William F. Koch, Ph.D., Judith A. Yost, M.A., M.T.(ASCP)
Immediate Past President Carolyn D. Jones, J.D., M.P.H. Health Care Financing
National Institute of Standards Health Industry Manufacturers Administration
and Technology Association
John V. Bergen, Ph.D.,

Executive Director
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Contents
Abstract........................................................................................................................................i
Committee Membership ................................................................................................................v
Active Membership .................................................................................................................... vii
Matrix of NCCLS Laboratory Automation Standards ................................................................... xvi
Preface to Laboratory Automation Standards ............................................................................... xix
Foreword ................................................................................................................................ xxiii
1 Introduction .....................................................................................................................1
2 Scope...............................................................................................................................1
3 Definitions .......................................................................................................................2
Part I: Specimen Status .............................................................................................................. 12
4 Transfer of Specimen Status Information.......................................................................... 12

4.1 Background........................................................................................................ 12
4.2 Specimen Information......................................................................................... 12
5 Performance of Quality Control (QC) Tasks..................................................................... 18
5.1 General Overview............................................................................................... 18
5.2 Participation in the QC Process by the Laboratory Automation System .................. 20
Part II: Laboratory Automation System (LAS) Status.................................................................... 21
6 Assumptions .................................................................................................................. 21
6.1 LAS Configuration ............................................................................................. 21
7 Status of Critical LAS Parameters.................................................................................... 21
7.1 Instrument and LAS Diagnostics ......................................................................... 21
7.2 Inventory ........................................................................................................... 23
7.3 Test/Process Names and Calibration .................................................................... 25
7.4 Quality Control (QC) .......................................................................................... 26
8 Status of Availability to External Action .......................................................................... 26
9 Performance Metrics of the LAS...................................................................................... 27

9.1 Monitor Results .................................................................................................. 27
9.2 Rate and Speed................................................................................................... 27
9.3 Maintenance....................................................................................................... 27
9.4 Workload Analysis ............................................................................................. 28
9.5 Production and Workflow ................................................................................... 28
9.6 Errors and Events ............................................................................................... 28
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Contents (Continued)
References ................................................................................................................................. 29
Summary of Comments and Subcommittee Responses.................................................................. 30
Related NCCLS Publications ....................................................................................................... 33
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Number 4 NCCLS
Matrix of NCCLS Laboratory Automation Standards
The laboratory automation standards documents, AUTO1, AUTO2, AUTO3, AUTO4, and AUTO5 are
interdependent with respect to their implementation in automated laboratory systems. The matrix
describes the engineering relationships between the standards elements in each of the five documents.
This matrix is provided so that designers and engineers, as well as users and customers, understand the
relationships between the different standards' components in an automated system. The matrix format
allows the users of one document to easily identify other standard elements, which relate to the standard
elements in the document or documents from which they may be working, to design a system correctly.
How to Read the Matrix (See matrix on the next page.)
The numbers listed on the horizontal (X) and vertical (Y) axes contain multiple -digit numbers (e.g.,
(1)5.4, (5)5.4.1.3).
The ‘first digit’ (in parentheses) represents one of the five automation documents (e.g., (1)5.4 is from
AUTO1; (5)5.4.1.3 is from AUTO5).
The ‘remaining digits’ represent the specific section of that document.
The symbol XX represents the direct ‘engineering relationship’ between two sections.
The symbol ## represents the section’s 'self', when it has been lined up with itself on the other axis.
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Matrix of NCCLS Laboratory Automation Standards
This matrix cross-links sections from NCCLS documents, AUTO1, AUTO2, AUTO3, AUTO4, and AUTO 5.
AUTO4-A
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Volume 21 AUTO4-A
Preface to Laboratory Automation Standards
Background
In late 1996, NCCLS agreed to undertake the complex and challenging task of managing an effort to
develop standards for clinical laboratory automation, based upon the urgent request of many leading
individuals and institutions in the field. Standardization was needed to overcome difficulties and
unnecessary costs incurred by laborator ies and manufacturers in their efforts to integrate and simplify
laboratory functions using technology.
As a result of discussions at an annual meeting of the International Conference on Automation, Robotics,

and Artificial Intelligence Applied to Analytical Chemistry and Laboratory Medicine (ICAR) in 1994, an
interested group of individuals had formed the Clinical Testing Automation Standards Steering
Committee (CTASSC). The CTASSC approached NCCLS’s leadership seeking collaboration, and
believing that the desired standards could best be developed utilizing the unique voluntary consensus
process, resources, and expertise of NCCLS and its member organizations. It was expected that
cooperation would also be necessary with other complementary standards-developing bodies, such as
ASTM, IEEE, and HL7.
The original shared vision was to take advantage of market forces within the industry and of the benefits
of implementing prospective standards in the context of market forces and industry support so that
customers (laboratories) and vendors could enjoy products that function together, and buyers and
suppliers could agree on a format for laboratory automation systems.
NCCLS accepted the challenge and committed to the following:
• NCCLS’s voluntary consensus process would be utilized to ensure balance, fairness, and broad
review of documents by all institutions affected by the effort.
• The project would be global in scope and participation.
• Sources and mechanisms for funding would be identified to ensure that the projects would be given
high priority to achieve timely completion.
NCCLS surveyed the interest of all institutions likely to be affected by the proposed standards effort, and
confirmed high interest in providing both expertise and financial support. NCCLS presented the proposal
at several meetings in the United States, Japan, and Europe to increase awareness of the activity and to
invite broad, global participation. Based upon favorable response to the proposals, the NCCLS Board of
Directors authorized the creation of a new Area Committee on Automation, chaired by Dr. Rodney S.
Markin, with Mr. Paul S. Mountain serving as its vice-chairholder.
Mission Statement
The mission of the Area Committee on Automation is:
“…to identify the need for, set priorities for, and manage and coordinate the development of compatible
standards and guidelines that address, in a prospective manner, the design and integration of automated
clinical laboratory systems worldwide. In addition, the area committee will foster communication of the
issues and developments worldwide.”
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Subcommittee Activities
Based upon the recommendations of the new area committee, the Board authorized establishment of five
subcommittees to manage the development of the following documents:
• AUTO1—Specimen Container/Specimen Carrier contains standards for the design and manufacture
of specimen containers and carriers used for collecting and processing samples, such as blood and
urine, for testing on laboratory automation systems.
• AUTO2—Bar Codes for Specimen Container Identification provides specifications for linear bar
codes on specimen containers for use on laboratory automation systems.
• AUTO3—Communications with Automated Systems facilitates accurate and timely electronic

exchange of data and information among automated instruments, laboratory automation systems, and
other information systems.
• AUTO4—Systems Operational Requirements, Characteristics, and Informational Elements

provides standards of interest to operators for display of system status information such as specimen
location, reagent supply, and warnings and alerts to support laboratory automation operations.
• AUTO5—Electromechanical Interfaces provides guidance for the standardization of

electromechanical interfaces between instruments and/or specimen processing and handling devices
and automation systems in the automated laboratory.
The five subcommittees began their efforts in the spring of 1997, with goals to develop proposed
standards suitable for publication and review by the end of 1999 consistent with the formal NCCLS
consensus process, and to advance them to the approved consensus stage in 2000.
Validation of Designs, Systems, and Software
The five laboratory automation standards are tools to help in the design, development, and
implementation of Laboratory Automation Systems (LAS) for the clinical laboratory. Each standard may
be used fully or in part, whether or not the intent is to design a completely automated or semiautomated
system. These standards provide specifications that can be adhered to and verified during various phases
of development for each LAS project. Adherence to standards alone does not ensure valid system design.
Design validation confirms that the medical devices (LAS) meet user needs and intended use. Software
validation is also a required component of the design validation of a medical device.a Also refer to
NCCLS document GP19—Laboratory Instruments and Data Management Systems: Design of Software
User Interfaces and End-User Software Systems Validation, Operation, and Monitoring.
Attributes of Standards for Laboratory Automation Systems
It was agreed by the Area Committee on Automation that all of the laboratory automation system
standards should share the following attributes:
• Prescriptive – Essential requirements should be prescriptive, and should define only those features
essential for compatibility of instruments, devices, and laboratory automation systems.
a
A good source of information on these and related subjects, plus other medical device regulations can be found on FDA/CDRH
web pages: http://www.fda.gov/cdrh/.
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Volume 21 AUTO4-A
• Prospective – Standards should describe the desired and necessary attributes whic h will enable and
enhance the connectivity of laboratory automation system components in the future; the creation of a
laboratory automation system from components should not be constrained by obsolete or inadequate
technology which may be in current use.
• Inclusive – Current technology with widespread use should not be excluded unless it impedes
connectivity; in some instances, a future date for discontinuation of a technology may be
recommended to encourage upgrades, providing sufficient time for interested laboratories or suppliers
to comply with new requirements.
• Explanatory – In cases where exclusions are recommended that are not obvious, or where consensus
is not achieved, the documents should include a brief rationale and, possibly, a description of
opposing viewpoints.
• Differentiating – In view of the complexity of the tasks, documents should differentiate between
imperative prescriptions ("must" verbal forms) and discretionary recommendations ("should" verbal
forms).
• Enabling of Innovation – The concept of "prescriptive, essential requirements" should be employed

to ensure that performance requirements rather than design specifications are utilized to the extent
possible.
• Consistent – Each document should be written to be "self-sufficient" with respect to the scope of its
individual effort. The five documents are interrelated and interdependent, and presented in a
consistent style using cross-references and a common glossary of terms (definitions) giving the
appearance of a collection of documents.
The five interrelated automation standards are a system of related documents that are available separately
or packaged in a manner similar to NCCLS “specialty collections.”
The clinical laboratory automation standards effort has attempted to engage the broadest possible
worldwide representation in committee deliberations. Consequently, it was reasonable to expect that
controversies existed and issues remained unresolved at the time of publication of the initial proposed-
level documents. A mechanism for resolving such controversies through the subcommittees and the Area
Committee on Automation was employed during the review and comment process.
The NCCLS voluntary consensus process is dependent upon broad distribution of documents for review
and comment and upon the expertise of reviewers worldwide whose comments add value to the effort. At
the end of the comment period, each subcommittee was obligated to review all comments and to respond
in writing to all which are substantive. Where appropriate, modifications were made to the respective
document, and all comments, along with the subcommittee's responses, are included in the Summary of
Comments and Committee Responses at the end of each document.
Special Recognition of Global Participation
The NCCLS Board of Directors wishes to give special recognition and thanks to several organizations
which have taken leadership roles in the development of these standards, including the Japanese
Committee for Clinical Laboratory Standards (JCCLS), the Japanese Society for Clinical Chemistry
(JSCC) and the International Federation of Clinical Chemistry (IFCC). These and other organizations
have helped shape the global scope of these documents.
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NCCLS can only succeed in fulfilling its responsibilities with the cooperation of other organizations and
individuals. In view of the economic and quality benefits expected by laboratory practitioners and
manufacturers upon implementation of standardization in automation, broad participation and cooperation
was sought and obtained, and is gratefully acknowledged. NCCLS will continue to achieve a position of
world leadership and influence in the development and harmonization of global standards for the
healthcare community.
Recognition of the Efforts of Other Standards Organizations
NCCLS would like to acknowledge and thank the volunteers who are active participants in the related
work of other standards organizations for their contributions to the laboratory automation program. Their
effective leadership and outstanding volunteer service during the development and successful completion
of the automation standards is greatly appreciated. This special recognition includes volunteers who are
participants in the following standards organizations:
American National Standards Institute (ANSI) Health Informatics Standards Board (HISB)
ASTM Committee E31
Health Level 7 (HL7)
International Organization for Standardization Technical Committee 212 (ISO/TC 212)
Institute of Electrical and Electronics Engineers, Inc. (IEEE)
International Federation of Clinical Chemistry (IFCC)
Japanese Association of Healthcare Information Systems (JAHIS)
Japanese Committee for Clinical Laboratory Standards (JCCLS)
Japanese Society for Clinical Chemistry (JSCC)
Recognition of Laboratory Automation Fund Contributors
Many of the large instrument and automation system vendors and the users of the technology recognized
the clear need to develop standards for clinical laboratory automation and information systems and
actively supported NCCLS in meeting this need through the efforts of the Area Committee on
Automation. To achieve standardization and ensure that automation projects do not compete with other
NCCLS projects for resources, a Laboratory Automation Development Fund was created. We express our
appreciation to all organizations that have supported this important program.
A list of Laboratory Automation Development Fund contributors is included on the inside front cover
of this document.
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Foreword
Laboratory Automation Systems (LAS) utilize robotics, instruments and/or specimen processing/handling
devices, and information systems to accomplish specimen identification and preparation; specimen
container transportation; specimen analysis; and data processing in the clinical laboratory. Over the past
several years, several LAS systems have been introduced into the marketplace. They are complex
systems and require the interaction of a central automation system (process control component) with
components of the analytical process, such as specimens and aliquot containers; specimen carriers;
docking systems; bar-coding devices; and instruments and/or specimen processing/handling devices.
NCCLS document AUTO4—Laboratory Automation: Systems Operational Requirements,
Characteristics, and Information Elements has been designed as a set of standards to guide manufacturers
of both LAS systems and their components. It has been developed through the consensus of interested
people who have broad expertise in the manufacture and use of laboratory automation systems.
The NCCLS Subcommittee on System Status formed three working groups: 1) Specimen Identification,
2) Coding of Events, and 3) Status of the Components of the Clinical Laboratory Automation System.
The efforts of these working groups were consolidated into what became Parts I and II of this standard.
A portion of this standard (AUTO4) refers to the related NCCLS document AUTO3—Laboratory
Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and
Information Systems, which specifies HL7 triggers, messages, as well as numbers for fields and tables,
and has been developed concurrently by the Subcommittee on Communications with Automated Systems.
AUTO4 is designed to define elements of an automated system for laboratories and manufacturers, while
AUTO3 is designed to explain the functions of these elements.
The goal of this document is to delineate the operational requirements, characteristics, and information
elements required to define the status of instruments and/or specimen processing/handling devices
connected to and interacting with the LAS. The intent of this document is to facilitate the compatibility
between the instruments and/or specimen processing/handling devices and LAS. The standardized system
status information exchange should help provide continuous, uninterrupted operation of the laboratory
automation system with appropriate human intervention.
These specifications are also intended to complement the interrelated NCCLS standards developed by
other automation subcommittees and to support overall operational goals for future development in
laboratory instrumentation and automation:
AUTO1—Laboratory Automation: Specimen Container/Specimen Carrier;

AUTO2—Laboratory Automation: Bar Codes for Specimen Container Identification;
AUTO3—Laboratory Automation: Communications with Automated Clinical Laboratory Systems,
Instruments, Devices, and Information Systems; and
AUTO5—Laboratory Automation: Electromechanical Interfaces.
Key Words
Aliquot, audit trail, device, diagnostics, errors, events, hemolysis, icterus, instruments, inventory, LAS,
lipemia, LIS, metrics, process control, quality control, specimen, statistics, system performance, system
status, volume
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Laboratory Automation: Systems Operational Requirements, Characteristics,

and Information Elements; Approved Standard
1 Introduction
There are now several Laboratory Automation Systems (LAS) in the marketplace. Since these systems
interact directly with a variety of instruments and/or specimen processing/handling devices, as well as
Laboratory Information Systems (LIS), there is a need to establish standard protocols and formats to
which manufacturers of LAS, LIS, and instruments and/or specimen processing/handling devices can
adhere. Communication of the status of the various components of an LAS to the process control
component is a necessary part of the system. Standard schemes of presentation and format for system
status monitoring will provide guidance to the manufacturers of components of such systems.
Because of the complementary nature of both documents, NCCLS document AUTO4? Laboratory
Automation: Systems Operational Requirements, Characteristics, and Information Elements, contains
several cross-references to NCCLS document AUTO3? Laboratory Automation: Communications with
Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems. In order to
maintain the integrity of the two documents, and provide the readers/users of both documents with the
most useful and current information, the subcommittee has provided the following note:
Sections of this document correspond directly to Section 6 of the interrelated NCCLS document AUTO3,
which specifies HL71,2 triggers, messages, segments, as well as numbers for fields and tables, and are
footnoted throughout the text.
2 Scope
Laboratory automation involves the complex interaction of a process control component of the LAS;
instruments and/or specimen processing/handling devices; information systems; and other components,
such as specimen containers and carriers, docking systems, bar-code devices, and the patient’s specimen.
There is a need for a uniform approach among instruments and/or specimen processing/handling devices
and LAS manufacturers to monitor the status of these components. This standard identifies and suggests
uniform ways of communicating essential data elements that describe the status, location, integrity,
quality control, and other relevant characteristics of the components of the LAS. These standard formats
are meant to inform and guide manufacturers in the development of LAS status monitoring. This
standard has been developed through a consensus process that includes people who collectively possess a
broad range of knowledge in the manufacture and use of laboratory automation.
This standard fits into the series of interrelated NCCLS automation standards AUTO1—Laboratory
Automation: Specimen Container/Specimen Carrier; AUTO2—Laboratory Automation: Bar Codes for
Specimen Container Identification; AUTO3—Laboratory Automation: Communications with Automated
Clinical Laboratory Systems, Instruments, Devices, and Information Systems; and AUTO5—Laboratory
Automation: Electromechanical Interfaces.
An NCCLS global consensus standard. ©NCCLS. All rights reserved. 1

Number 4 NCCLS
3 Definitions b
Some of the computer-, automation-, or robotics–related terms used in the five interrelated NCCLS
automation documents can be found in ANSI X3.172 3 , ANSI X3.182-1990 4 , ASTM D9665 , ASTM
E10136 , ASTM F1497 , ASTM F11568 , IEEE 100,9 IEEE 610,10 IEEE 100711 , and HL7 Version 2.41,2 :
ACK, n – 1) A data field name for a general acknowledgment message as specified in the HL7 protocol
(HL7 V2.4 1 ); 2) A communication control character transmitted by a receiver as an affirmative response
to a sender (ASTM).
ADT, n – 1) An abbreviation for admission, discharge, or transfer; 2) A data field in a hospital

information system denoting admission, discharge, or transfer.
Aliquot, n – A portion of a specimen placed in a separate container to facilitate concurrent testing or to

hold in reserve for future use; NOTES: a) The portion of the specimen is typically removed from the
original specimen after initial processing, such as centrifugation, to obtain serum or plasma samples, and
is considered to be chemically identical to all other subdivisions of an original sample of serum, plasma,
urine, cerebral spinal fluid (CSF), etc.; b) It may be necessary to identify the aliquot as an individual
specimen distinct from the original specimen in a collection container labeled with a unique identifier that
may be linked to or associated with the primary collection container.
Analyzer, n – An instrument and/or specimen processing and handling device that performs
measurements on patient specimens of quantitative, clinically relevant analytes; NOTE: A portion of a
patient's specimen is consumed in the analytic process.
ANSI, n – Acronym/Initialism for American National Standards Institute; NOTE: In Automation, the
Microsoft Windows ANSI character set is composed of ISO 8859/x plus additional characters.
ASTM, n – The official name of the organization formerly known as the American Society for Testing
and Materials; NOTE: ASTM has developed various high- and low-level communications protocols.
Audit trail, n – An electronic log of transactions, detailing all events which have occurred in the
laboratory automation system, including date and time of these events, which operator was responsible or
directs processes, and any additional details.
Automated, adj – A characterization applied when all analytical processes, including sample and reagent
uptake, sample/reagent interaction, chemical/biological analysis, result calculation, and result readout are
mechanized. NOTE: These are usually controlled by a set of stored, modifiable instructions.
Automated instrument, n – A laboratory instrument that may or may not be connected to a laboratory
information system (LIS), hospital information system (HIS), and/or laboratory automation system
(LAS), which performs measurements on a patient's sample; NOTE: These instruments may have
specific hardware and/or software modifications that allow interface to a laboratory automation system.
Automation system, n - An automation system refers to a variety of possible systems that can include
some of the following types: automated instruments, laboratory information systems (LIS), laboratory
automation systems (LAS), hospital information systems (HIS), and front-end processing devices.
b
Some of these definitions are found in NCCLS document NRSCL8—Terminology and Definitions for Use in NCCLS Documents. For complete
definitions and detailed source information, please refer to the most current edition of that document.
2 An NCCLS global consensus standard. ©NCCLS. All rights reserved.

Volume 21 AUTO4-A
Bar code , n – 1) An array of parallel rectangular bars and spaces that creates a symbology representing a
number or alphanumeric identifier; 2) An array of rectangular lines and spaces that are arranged in a
predetermined pattern following unambiguous rules and representing data that are referred to as
characters (ASTM F11568 ); 3) An identification code consisting of a pattern of vertical bars whose width
and spacing identifies the item marked; NOTE: The code is meant to be read by an optical input device,
such as a bar-code scanner. Applications include retail product pricing labels, identification of library
documents, and railroad boxcar identification. (IEEE 610.2 10)
Bar length, n - The length of the bars in the bar code.
Bottom of cap, n - The farthest point from the top of the container/test tube that the cap reaches; NOTE:
This point may be inside the tube.
Bottom of container//Bottom of tube , n - The portion of the container/test tube farthest from the cap
(see Point of reference ).
Bottom of tube, n - See Bottom of container.
Carrier, n - See Specimen carrier.
Character, n - 1) The smallest abstract element of a writing system or script; NOTE: A character refers
to an abstract idea rather than to a specific shape; 2) A code element; 3) A member of a set of elements
upon which agreement has been reached and that is used for the organization, control, or representation of
information; NOTE: Characters may be letters, digits, punctuation marks, or other symbols, often
represented in the form of spatial arrangement of adjacent or connected strokes or in the form of other
physical conditions in the data media; 4) A letter, digit, or other symbol that is used as part of the
organization, control, or representation of data; NOTE: A character is often in the form of a spatial
arrangement of adjacent or connected strokes. (ASTM F149 7 ); 5) In data transmission, one of a set of
elementary symbols which normally include both alpha and numeric codes plus punctuation marks and
any other symbol which may be read, stored, or written and is used for organization, control, or
representation of data; 6) In computers, a letter, digit, or other symbol used to represent information.
(IEEE 610.1, 610.5, 610.12 10 )
Clinical laboratory automation, n - The integration of laboratory personne l and preanalytical,

analytical, and postanalytical processes and information systems.
Clinical laboratory automation systems , n - An assemblage of components that mechanically and

electronically transfers, analyzes, and processes information and material related to clinical diagnostic
testing of patient specimens, controls, calibrators, standards, and images.
Closed-container sampling//Closed-tube sampling, v – The action of aspirating a sample from a

container/tube with the closure in place, requiring the sample probe to pierce the closure of the
container/sample container.
Closed-tube sampling, v - See Closed-container sampling.
Container//Tube//Test tube, n - See Specimen collection container.
Cycle time components, n – The identified time segments of the process of moving from one sample to
the next, including: presentation of specimen along transportation system to docking site at instrument;
identification/recognition that the correct specimen is in place; either direct aspiration from specimen
container by probe, or transfer of specimen container to instrument, aspiration, and return of specimen

Number 4 NCCLS
container to specimen carrier/transportation system; departure of completed specimen container;

movement into position of next specimen container.
Decapping, v – The removal of a closure from a specimen container.
Delimiter, n – 1) A symbol used to separate items in a list; 2) In software data management, a bit,
character, or set of characters used to denote the beginning or end of a group of related bits, characters,
words, or statements. For example, the ampersand "&" in the character string "& APPLE &." (IEEE
610.5, 610.1210 )
Device, n – In Automation, a unit to prepare specimens for analysis, or to handle specimens after they
have been analyzed by another instrument, e.g., automated centrifuges, automated aliquotters, automated
storage and retrieval.
Directions of the specimen, Transportation system, Instrument or Specimen processing and

handling device interfaces, n - The orthogonal axes; NOTE: a) These axes are demonstrated in Figure 1.
Z: Vertical Travel of Sample Probe or Sampling Device
X: Specimen Travel Direction in Horizontal Plane
Y: Direction in Horizontal Plane Perpendicular to Specimen Travel
Figure 1. Physical Frame of Reference in a Three-Dimensional Space (X-Y-Z)
• X–direction, n - The direction that a specimen travels along a transportation system; NOTE: b)
Specimens would move along the X dimension as, for example, in transportation from station to
station in a laboratory (see Figure 2A).

Volume 21 AUTO4-A
Specimen Containers in
Carrier
Transport Mechanism
Figure 2A. X Direction
• Y–direction, n - The horizontal direction perpendicular to specimen travel along a transportation

system; NOTE: c) Specimens could move in the Y dimension away from a transport system to be
placed onto an instrument for analysis (see Figure 2B). The sample probe would move in the Y
dimension as it moves out from the instrument or specimen processing and handling device to a
position directly over the specimen container.
Instrument
(Analyzer)
Movement of
specimen to
instrument or
of probe from
instrument to
specimen
(Y direction)
Figure 2B. Y Direction
• Z–direction, n - The vertical dimension; NOTES: d) Specimens could be lifted in the Z dimension off
a transport system for transfer between locations; e) The center line of a container should be
controlled, so it is in the Z dimension; a specimen centering device would be referenced to the Z
dimension; a sample probe would follow the Z dimension as it moves downward into a specimen
container to aspirate serum, blood, etc. for analysis (see Figure 2C); f) Rotation about the Z
dimension may be used to locate and read the bar-code label on a specimen container or to assess the
quality of a specimen in terms of turbidity, hemolysis, icterus, etc.

Number 4 NCCLS
Z Direction
Vertical Movement of Probe or

Specimen Specimen Container
Container
Figure 2C. Z Direction
Directions of the sample, Transportation system, Instrument or Specimen processing handling

device and interfaces, n - See Directions of the specimen, etc.
Direct track sampling, n – The process in which aspiration of a sample occurs directly from the
specimen container while it is on the transportation system, whereby the instrument probe extends to
reach the specimen container on the transportation system; NOTE: The integrity of this process requires
reliable agreement between the transportation system and the instrument and specimen processing and
handling devices regarding point of reference (POR) to guide movement of the probe to the specimen.
Docking site , n – 1) The location of the physical interface between two components of a system; 2) In
Automation, the interface between the transportation system and the instrument and/or the specimen
processing and handling devices where the specimen container arrives for sampling to occur.
Encoding, n – 1) A system of assigning numeric values to characters; 2) A means of producing a unique

combination of bits (a code) in response to an analog signal. (IEEE-1007 11)
ENQ, n - ASCII character denoting the word “enquiry,” which requests establishment of the
communication phase; NOTE: Part of the ASTM E1381 12 and E1394 13 protocols.
EOT, n - ASCII character denoting “end of transmission,” indicating the end of a communication phase;
NOTE: Part of the ASTM E138112 and E139413 protocols.
ERR, n – An HL7 error segment (HL7 V2.4 1 ).
Filler, n – A person or service that produces the observations requested by the placer.
Flection, n – The point at which the vertical (straight) walls of the specimen container bend to form the
base.
Health Level 7, n – The highest level (application) communications model for open systems
interconnection (OSI); NOTE: Level 7 supports security checks, participant identification, availability
checks, exchange mechanism negotiations, and data exchange structuring.

Volume 21 AUTO4-A
Healthcare Informatics Standards Board, HISB, n – An organization that coordinates activities of all
standards developers in the healthcare informatics area of ANSI organizations.
High-level protocol, n - A protocol describing the content of messages passed between systems.
HIS, n – Initialism for Hospital Information System.
HISB , n – Initialism for Healthcare Informatics Standards Board.
HL7, n – Abbreviation for Health Level 7. 1,2
Hospital information system, HIS, n – A data management system which usually supports functions
external to the laboratory, e.g., admission, discharge, and transfer (ADT) functions.
IEEE, n – Initialism for Institute of Electrical and Electronics Engineers, Inc.
IFCC, n – Initialism for International Federation of Clinical Chemistry.
Instrument, n – An analytical unit which uses samples to perform chemical or physical assays (e.g.,
chemistry analyzer, hematology analyzer).
Inventory, n – The materials available on an instrument used to support the operation of that instrument.
ISO 8859, n – Acronym for the International Standards Organization’s eight-bit character encoding that is
also called code page1252, Western European, or Latin1.
JAHIS, n - Initialism for Japanese Association of Healthcare Information Systems Industry.
JCCLS, n - Initialism for Japanese Committee for Clinical Laboratory Standards.
JIS, n – Initialism for Japan Industry Standard.
JSCC, n - Initialism for Japanese Society for Clinical Chemistry.
Label, n – 1) The display of written, printed, or graphic matter upon the immediate container of any
article; 2) In Automation, the paper and attached adhesive coating on which the bar code and other
human readable information is printed; 3) A piece of paper or other material to be affixed to a container
or article, on which is printed a legend, information concerning the product, or addresses. It may also be
printed directly on the container. (ASTM D966 5 ); 4) In computer software, a name or identifier assigned
to a computer program statement to enable other statements to refer to that statement; 5) One or more
characters within or attached to a set of data, that identify or describe the data. (IEEE 610.12 10 )
Laboratory automation system, LAS, n - A system of information and hardware technology that allows
the operation of the clinical laboratory process without significant operator intervention; NOTE: Typical
functionality includes information system control of the instruments through direct LAS interfacing,
including any technology that manipulates the specimen (i.e., centrifuge); transportation of the specimen;
result evaluation, repeat testing, reflex testing; and quality assessment and results reporting.
Laboratory equipment control interface specification, LECIS, n – A high-level protocol that defines
message content for standard behaviors or interactions for remote control of analytical instruments and
devices (ASTM E1989 14 ).

Number 4 NCCLS
Laboratory information system, LIS, n - The information system that is responsible for management of
data regarding patient specimen identification, tests requested, results reported, quality control testing,
and other aspects of sample analysis; NOTES: a) The LIS interfaces directly with the LAS to
communicate patient, visit, container, test orders, specimen status, and results about specific testing to be
done; b) Instrument or specimen processing and handling devices may be interfaced with the LIS or the
LAS to direct specific testing and to retrieve results for reporting; c) The LIS is frequently also interfaced
to a clinical information system for use by physicians and other medical personnel.
Latin 1, n – A specific, eight-bit, character encoding system, also known as ISO 8859, code page1252, or
Western European.
LECIS, n – Acronym/Initialism for Laboratory Equipment Control Interface Specification (ASTM E1989 14).
Location, n – A physical place within the laboratory, with a unique identifier (e.g., refrigerator shelf
number, instrument buffer ID, track identifier). (See Figure 3.)
Logical observations identifiers names and codes, LOINC, n - A systematic approach to formal names
and codes for laboratory results and clinical variables with numeric, coded, or narrative text values
developed by a consortium of laboratories, system vendors, hospitals, and academic institutions.
LOINC, n – Acronym/Initialism for Logical Observations Identifiers Names and Codes (refer to website,
http://www.regenstrief.org/loinc/loinc.htm).
Low-level protocol, n – A protocol describing the electrical and mechanical connections of the physical
layer of communication between systems and the software protocol definition.
Medical information bus , n – A communication service designed for ICU, OR, and ER bedside devices
(IEEE).
MEDIX, n – A data model for medical data interchange between diverse systems (IEEE).
Message , n - The body of text information concerning orders for, or results of, diagnostic studies, tests, or
clinical observations transmitted at one time between two systems.
MSA , n - An HL7 abbreviation for message acknowledgment segment (HL7 V2.4 1 ).
MSH, n - An HL7 abbreviation for message header segment (HL7 V2.4 1 ).
OBR, n – An HL7 abbreviation for observation request.
Observation request, OBR, n – A segment used to transmit information specific to an order for a
diagnostic study or observation, physical exam, or assessment, and define the attributes of a particular
request for diagnostic services (e.g., laboratory, EKG) or clinical observation (e.g., vital signs or physical
exam) (HL7 V2.4 1 ).
Observation/Result segment, OBX, n – A segment used to transmit a single observation or observation

fragment, and representing the smallest indivisible unit of a report; NOTE: Its principal mission is to
carry information about observations in report messages (HL7 V2.4 1 ).
OBX, n – An HL7 abbreviation for observation/result segment.

Volume 21 AUTO4-A
Open-container sampling//Open-tube sampling, v – The action of aspirating a sample from a specimen

container from which the closure has previously been removed; NOTE: The sample probe contacts the
surface of the specimen without other physical barriers.
Open-tube sampling, v – See Open-container sampling.
ORC, n – An abbreviation for an HL7 common order segment (HL7 V2.4 1 ).
PID, n – In Automation, an HL7 abbreviation for HL7 patient identification segment (HL7 V2.41).
Pitch, n – The center distance between two specimen containers in a carrier or between two sequential
specimen container carriers.
Placer, n – In Automation, a person or service that requests observations; NOTE: An example would be
the physician, the practice, the clinic, or ward service that orders a test, x-ray, vital signs, etc.
Point of reference//Point in space, POR, n – In Automation, the intersection of the xy plane and an
infinite line in the ‘z’ direction. NOTE: The POR is the reference from which all positioning and
alignment of specimen containers is measured.
Process control, n – A method of managing the process required to produce a result from a patient
specimen and to handle/manipulate/transport the specimen, as applied to the NCCLS standards, under the
control or supervision of software that controls instruments/devices and automation hardware.
Process instruments , n – In Automation, components of an automated laboratory comprising the

automated devices that perform a multitude of pre- and postanalytical tasks, and perform nonanalytical
tasks on specimens, containers, carriers, and similar processes.
PV1, n – An HL7 abbreviation for a patient visit segment (HL7 V2.4 1).
PV2, n – An HL7 abbreviation for a patient visit with additional information (HL7 V2.4 1 ).
Quiet zone , n – In Automation, the white {blank} space on a bar code immediately preceding the first
bar and immediately following the last bar.
Recap, v – To replace the closure on a specimen container, either with the original closure or with a new
replacement closure.
Robotic arm, n – A device capable of moving a specimen container, specimen carrier, or another object
in the X, Y, and Z directions; NOTE: Unless this device is an integral part of the LAS system, it is
considered an instrument for the purpose of this standard.
ROL, n – An HL7 abbreviation for a role segment.
Role segment, n – In Automation, a segment containing the data necessary to revise the records of the
person(s) involved, as well as their functional involvement in the activity being transmitted (HL7
V2.41 ).
Sample//(Specimen), n – A portion or aliquot withdrawn from a container for the actual test; NOTES: In
Automation, a) Samples are typically not placed in containers that will have to be uniquely identified, but
may go directly into the instrument or specimen processing and handling device test stream or may be
placed in sample cups unique to the instrument or specimen processing and handling device; b) The
identification (ID) of the specimen is typically assured by computer linkage of the pipetting or aspiration

Number 4 NCCLS
step to the identification (ID) of the container from which it was obtained, or by a separate numbering
system for the sample cups that is internal to the analytical instrument or specimen processing and
handling device.
Sample carrier, n – See Specimen carrier.
Sample container, n – See Specimen collection container.
Sample -positioning system, n – See Specimen-positioning system.
Sample probe, n – See Specimen probe.
Service envelope , n – In Automation, the space around the transportation system and instruments that
may be accessed periodically for maintenance or repair of equipment; NOTE: A transportation system
and analytic instruments should not have mutually impinging service envelopes.
Shift-JIS-code , n – The Japan Industry Standard multibyte encoding system; NOTE: The codes are
numerically shifted from the codes used by the JIS standard X0208 15 ; hence the name.
SNOMED  , n – 1) An acronym for the Systematized Nomenclature of Medicine, a copyrighted work of

the College of American Pathologists; 2) A reference terminology that makes health care knowledge more
accessible and usable whenever and wherever it is needed; 3) Includes clinical findings, conclusions and
assessments, laboratory test results, diagnoses, living organisms, biological functions, drugs, chemicals,
body structures, specimens, occupations, physical agents, activities and forces, general modifiers, and
social contexts; 4) Current version, SNOMED Reference Terminology (SNOMED RT), and future
version SNOMED Clinical Terms (SNOMED CT), are compatible for use with healthcare standards HL7
and DICOM; 5) Previous versions (SNOMED II, 1979; SNOMED International, 1993-1999) are
encompassed in this new release. http://www.snomed.org.
Specimen, n – The discrete portion of a body fluid or tissue taken for examination, study, or analysis of
one or more quantities or characteristics, to determine the character of the whole; NOTE: The substance
may still be referred to as a specimen if it has been processed from the obtained specimen; thus, examples
of specimens include whole blood and serum or plasma prepared from whole blood; saliva; cerebrospinal
fluid; feces; urine; fingernail clippings; hair clippings; tissue samples, even if embedded in a paraffin
block; etc.
Specimen carrier//Sample carrier//Carrier, n - A device that holds the specimen container; NOTE:
The specimen carrier interfaces mechanically with the transportation system to move the specimen from
location to location, and may carry one specimen container or many specimen containers (see Figure 3).
Specimen collection container//Specimen container//Sample container//Container, n – The tube that

holds a patient specimen; NOTE: The container typically consists of a glass or plastic closed-end tube
with a removable closure on the opposite end (see Figure 3).

Volume 21 AUTO4-A
Specimen Spec.
Container Carrier
Tray
2037 2002 2123 2456
1 2 3 4 5 6
Location
Specimen
Container
Spec.
Carrier
5
04
4
2
10
3
3
02
2
4
13
1
Location
Figure 3. Relationship Among Specimen Container, Specimen Carrier, Tray, and Locations
Specimen-positioning system//Sample -positioning system, SPS, n - A device to position a specimen

container within acceptable tolerances of a POR.
Specimen probe//Sample probe, n – A part of an instrument or specimen processing and handling

device that aspirates fluid from a specimen and delivers it to the instrument for analysis; NOTE: The
sample probe can also be called sample proboscis, nozzle, needle, or sampling mechanism.
Stay clear zone , n - In Automation, the area between the instrument or specimen processing and
handling device and the automation hardware that must remain clear of any physical device, ensuring that
there is adequate access by the user or service person to either system.
Symbol, n – In Automation, a combination of bar-code characters, including start/stop characters, quiet

zones, data elements, and check characters which form a complete scanning entity.
Test mnemonics , n - Short, understandable contractions for test names.
Top of container//Top of tube , n – The open end of the container/test tube, closest to the cap.
Top of tube, n - See Top of container.
Tray, n – A holder for one or more carriers (optional). (See Figure 3.)
Tube//Test tube, n – See Specimen collection container.

Number 4 NCCLS
Unicode , n - A fixed-width, 16-bit worldwide character encoding system that was developed and is
maintained by the Unicode Consortium, supporting all national languages; NOTE: The Unicode
Consortium is a nonprofit computer industry organization.
X–direction, n - See Directions.
Y–direction, n - See Directions.
Z–direction, n - See Directions.
Part I: Specimen Status
4 Transfer of Specimen Status Information
4.1 Background
The specimen is collected, preanalytically processed if necessary, presented to one or more instruments
and/or specimen processing/handling stations, archived in short- or long-term storage, and eventually
discarded as appropriate. Each specimen may require a different set of process steps that are dependent
upon the assay to be performed. Centrifugation may be necessary to obtain serum or plasma from cellular
specimens such as whole blood. One or many aliquots of the specimen may need to be created to
facilitate multiple parallel analyses, or for storage. The steps of the process may need to be performed in a
specific order. A specimen that is to be shared between two or more instruments and/or specimen
processing/handling devices or manual assays may need to be analyzed as whole blood at one point, and
only after centrifugation and aliquotting transported at other assay points.
4.2 Specimen Information
Status, integrity, and location information of a specimen may be generated by any component or device in
an automation system ? the instruments and/or specimen processing/handling devices, automation
components, manual entry, etc. The current status and location (as well as an audit trail) should be
maintained by the process control component of the LAS.
It is recommended that the Laboratory Automation System (LAS) informs the external system (e.g., LIS)
about the current specimen status/location when the following events occur:
• when the specimen container enters the LAS (e.g., primary container arrives);
• when new specimen containers will be generated (aliquotted);
• when the specimen container significantly changes location or pathways within the LAS (e.g., will be
transported to analyzer or temporary storage);
• when the specimen container leaves the LAS (e.g., will be sorted in special carriers/trays for long-
term storage or for instruments not mechanically connected with the LAS container transport); and
• when significant status changes of the specimen container processing occur (e.g., processing errors).

Volume 21 AUTO4-A
It is critically important that the automation system be able to maintain certain essential information
elements and retain a full audit trail for each original specimen and for each aliquot that is created. The
original specimen and subsequent aliquots may be in different states and locations at any point in time.
4.2.1 Specimen Location Information
4.2.1.1 Specimen Container Location
The specimen container location should be generated and maintained over time in the process control
component of the LAS. The physical and logical configuration of the individual laboratory would
determine the characteristics stored in the process control component of the LAS. c
4.2.1.2 Aliquot Generation
If a device creates aliquots, the process control component of the LAS would create links between the
aliquot ("secondary/aliquot specimen container") and the original specimen ("primary specimen
container"). There must be a means of identifying all aliquots. In addition, any identified characteristics
of the primary specimen should also be related in the database to the aliquots.c
4.2.1.3 Specimen Container Storage
Location of the specimen/aliquot container should be identified by the LAS process control component
once the specimen/aliquot container is placed into storage.c
4.2.1.4 Example of Location Information
The identifiers of specimen containers, specimen carriers, trays, locations, and their positions, used in
these examples, correspond to Figure 3.
The following examples refer to the ‘segments’ defined in NCCLS document AUTO3 regarding
communications with the LAS:
• Primary Sample (Container ID=123456) is in the 2nd position of a transport carrier (Carrier ID=2002),
in the 4th position in tray (ID=033) of the output buffer #1 of instrument XYZ.
• Aliquot Sample Container (ID=123456A) is in the 3rd row and 2nd column (consecutive position=6) of
a sorter carrier (Carrier ID=045), in the 4th slot of the sorter ABC.
The internal accession ID for this sample is 990305123456; the external accession ID does not exist. The
instruments do not assign an equipment container ID.
c
See Section 6 of the most current version of NCCLS document AUTO3— Laboratory Automation: Communications with Automated Clinical
Laboratory Systems, Instruments, Devices, and Information Systems, which specifies HL7 triggers, messages, as well as numbers for fields and
tables.

Number 4 NCCLS
The table below shows the values in the corresponding fields of the EQU and SAC segments for primary
and aliquot samples. ("—" = an empty field; shaded rows are not relevant for considerations of this
example.)
Field EQU EQU (Bar-coded Comment

(Primary Sample) Aliquot Sample)
1 Equipment XYZ ABC
Identifier
Field SAC SAC (Bar-coded Comment

(Primary Sample) Aliquot Sample)
1 External Accession — —
ID
2 Accession Identifier 990305123456 990305123456
3 Container Identifier 123456 123456A
4 Parent Container — 123456
Identifier
5 Equipment — —
Container Identifier
9 Carrier Type TRANS-CARRIER SORTER-

CARRIER
10 Carrier Identifier 2002 045
11 Position in Carrier 2 6 The position could be
transmitted as multidimensional
field, e.g., 3^2.
12 Tray Type OUTPUT-TRAY —
13 Tray Identifier 033 —
14 Position in Tray 4 —
15 Location 1 4 The equipment identifier can be
added here, because the
location is repetitive field, e.g.,
1\XYZ and 4\ABC.
4.2.2 Specimen Status Information
4.2.2.1 Communication of Specimen Characteristics
Measured characteristics of a specimen should be quantified (where appropriate) and transmitted as

standard units of measure. As an example, the presence of hemolysis should be reported as 0.5, 1, 2, or 3
g/L of hemoglobin in place of semiquantitative scales such as 2+ hemolysis. If qualitative estimations are
used, these should be standardized as much as is feasible and expressed in standard units of measure.
Arbitrary scales may vary from laboratory to laboratory and the information they transmit is less likely to
be clinically useful from site to site. If a laboratory or reagent manufacturer develops information on the
level of hemolysis that causes a bias in an enzyme assay, this information is more usable to another
laboratory when it is given in standard units.c
c
tables.

Volume 21 AUTO4-A
4.2.2.2 Changes in Specimen/Aliquot Characteristics at Different Points in the Automation Process
These specimen status codes provide a functional nomenclature that describes the state of the specimen as
it moves through the automation system. Each specimen may require a different set of processing steps
that are dependent upon the assays to be performed. Centrifugation may be necessary to obtain serum or
plasma from cellular specimens such as whole blood. A specimen that is to be shared between two or
more instruments and/or specimen processing/handling devices or manual assays may need to be in the
form of whole blood for one instrument and/or specimen processing/handling device but may require
centrifugation and aliquotting prior to transporting the specimen to another instrument and/or specimen
processing/handling device. Refer to Section 4.2.2.5 for acceptable or recommended values.
4.2.2.3 Initial Determination of Specimen Quality
Prior to an assay, the quality of the specimen must be evaluated. The degree of hemolysis, lipemia, or
icterus or the presence of fibrin clots may significantly alter the results or may preclude the performance
of the assay due to interference. The temperature of the specimen and the temperature-related state (e.g.,
liquid, frozen, or thawed) over the life of the specimen following collection should also be measured or
determined, monitored, recorded, and transmitted to the process control component of the LAS.
Information about hemolysis, icterus, lipemia, and the presence of fibrin clots should be recorded for each
specimen/aliquot. Refer to Section 4.2.2.5 for acceptable or recommended values.
4.2.2.4 Monitoring Specimen/Aliquot Volume
The specimen/aliquot volume should be determined and may be accomplished by a variety of means
using either a preanalytic device or prior knowledge of the specimen container volume. Measured
volumes should be in milliliters (mL). To track volumes, each instrument and/or specimen
processing/handling device should transmit to the process control component the volume of
specimen/aliquot that it has consumed. Alternatively, the process control component of the LAS may
track specimen/aliquot volumes by subtracting the volume known to be used by each instrument and/or
specimen processing/handling device from the known volume originally stored in the process control
component. It is desirable that the operator be notified if the specimen container volume is not sufficient
for performing any or all of the assays. Refer to Section 4.2.2.5 for acceptable or recommended values.c
4.2.2.5 Status Fields Defining Specimen Attributes and Characteristics
The following defined specimen attributes and classifications should be tracked by the process control
component of the LAS.
1. Specimen volume: Initial, current, and available (measured or calculated values in mL).c
2. Specimen type/source: Coded value (e.g., arterial blood, cerebral spinal fluid (CSF), etc.). c Also
refer to Chapter 13 of HL7 version 2.4. 1
3. Specimen component: Specifically coded and user-defined coded value table. See suggested
values defined below.c
SUP Supernatant
SED Sediment
c
tables.

Number 4 NCCLS
BLD Whole blood, homogeneous

BSEP Whole blood, separated
PRP Platelet-rich plasma
PPP Platelet-poor plasma
SER Serum, NOS (not otherwise specified)
PLAS Plasma, NOS (not otherwise specified)
USR1-USR9 User-defined
4. Additive: Specifically coded and user-defined coded value table. See suggested values defined
below.c
NONE None
EDTK Potassium/K EDTA
EDTN Sodium/Na EDTA
HEPL Lithium/Li Heparin
HEPN Sodium/Na Heparin
C32 3.2% Citrate
C38 3.8% Citrate
BOR Borate
HCL6 6N HCL
5. Serum/plasma separator: Specifically coded value table. See suggested values defined below.c
This could be coded as part of the container type defined in Seq 08.
NONE Absent
SEP Separator present, type unspecified
6. Hemolysis: (In g/L.) In order to permit the use of an estimated range as well as a precise single
value, this field is a plain numeric (NM) data type (refer to HL7).1 Chapter 2, Section 2.8.37).
Using NM coding, either a single value or a range of values can be specified. Even when a
qualitative estimation is made, this should be expressed in standard quantitative values.c
7. Lipemia: Optical turbidity at 600 nm (in absorbance units.) This is also an NM data type (see
Item 6).c
8. Icterus: (In mMol/L of bilirubin.) This is also an NM data type (see Item 6). c
9. Fibrin: Specifically coded value table. See suggested values defined below. c
NONE Absent
FIBR Present
10. Artificial Bloodc:
NONE None
SFHB Stromal-free hemoglobin preparations
FLUR Fluorocarbons
c
tables.

Volume 21 AUTO4-A
11. Temperature: Specifically coded and user-defined coded value table. See suggested values
defined below. (This could also be the measured temperature.) c
UNK Unknown temperature

25C Room temp 25 °C
6C Refrigerate temp 4 to 8 °C
37C Body temp 37 °C
56C Inactive temp 56 °C
100C Boiling temp 100 °C
0C Freeze temp 0 °C
N20C Low temp – 20 °C
N70C Low temp – 70 °C
nnC Other temperature nn
NnnC Negative temperature nn
12. Dilution factor: The actual dilution factor. c
O Absent - Not diluted

UNK Present - Diluted, factor not known to the system
n Dilution factor (“3” would represent 1 part sample, 2 parts diluent)
13. Treatment: Specifically coded and user-defined coded value table. See suggested values defined
below.c
NONE None
LDLP LDL Precipitation
RECA Recalcification
DEFB Defibrination
ACID Acidification
NEUT Neutralization
ALK Alkalization
FILT Filtration
UFIL Ultrafiltration
14. Contaminants: Specifically coded and user-defined coded value table. See suggested values
defined below. (Could also be the actual contaminant, e.g., separator gel, etc.)c
NONE Absent
CNTM Present, type of contamination unspecified
15. Barrier/bottom values - sampling limits: Actual delta values in MM from the point of reference
(POR) and from the bottom of the specimen container to the separator will be supplied by the
LAS to the instrument and/or specimen processing/handling device. Refer to NCCLS document
AUTO3—Laboratory Automation: Communications with Automated Clinical Laboratory
Systems, Instruments, Devices, and Information Systems for usage c; also refer to NCCLS
c
tables.

Number 4 NCCLS
documents AUTO2—Laboratory Automation: Bar Codes for Specimen Container Identification

and AUTO5—Laboratory Automation: Electromechanical Interfaces.
16. Atmospheric exposure: Coded and user-defined value table.c
NONE Sealed container

ATM Opened container, atmosphere/duration unspecified
A60 Opened container, indoor atmosphere, 60 minutes duration
USR1-USR9 Nonstandard user-defined conditions
17. Special handling considerations: Specifically coded and user-defined coded value table. See
suggested values defined below. Refer to NCCLS document AUTO3? Laboratory Automation:
Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and
Information Systems for usage. c Also refer to NCCLS document AUTO5−Laboratory
Automation: Electromechanical Interfaces, Section 6, for standard precautions when handling
specimens.
NONE None
PRTL Protect from light
CFRZ Critical; frozen
CATM Critical; do not expose to atmosphere – Do not uncap
CREF Critical; refrigerated
CAMB Critical; ambient temperature
C37 Critical; maintain at 37 °C (e.g., cryoglobulin specimen)
USR1-USR9 Other user-defined considerations
4.2.2.6 Transmission of Changes in Specimen Attributes
Changes in any of the attributes during specimen transit through the automated system should be
transmitted to the process control component of the LAS. c
4.2.2.7 Use of Specimen Status Information
The LAS process control component or instruments and/or specimen processing/handling devices may
execute rules that spawn additional/add-on tests, or result in cancellation, rerouting, or commentary on
certain tests and specimens based on information about specimen/aliquot status. For example, potassium
assays would not be performed on specimens with hemolysis that exceed a user- or vendor-recommended
cut-off.
5 Performance of Quality Control (QC) Tasks
5.1 General Overview
Quality control (QC) data or information may be transmitted from an instrument or LIS to the process
control component of the LAS either as raw data or as interpreted results.
Raw QC data are generally transmitted in the standard format similar to that used to report results for
patient specimens (including the date and time), but are recognizable as QC data by one of the specimen
data fields, such as the accession number or the patient ID number. The central system should recognize
raw QC data as QC information, process the data in accordance with user-defined QC rules, select the
appropriate warnings listed in Section 7.4 on the basis of those rules, and clearly display the warnings to
the user.

Volume 21 AUTO4-A
When interpretations of the raw data are transmitted, the central system should recognize them, convert
them into the appropriate warning statuses listed in Section 7.4, and clearly display the warnings to the
user.
The criteria or rules that assign the QC information to the specific warning categories listed in Section 7.4
may be entered into the central system by the user directly, via the automated analyzer or the LIS.
NCCLS document AUTO3 has also included QC and calibration types and error identifiers.c
5.1.1 Material Identification
5.1.1.1 A standard means of identifying QC material should be applied throughout a laboratory.
5.1.1.2 A unique specimen ID should be used for each unique QC material introduced onto the LAS.
Thus, separate aliquots of the same lot of QC material introduced to the system at different
times would have the same specimen ID, or at least tightly linked IDs.
5.1.1.3 The process control component should store pertinent QC information, including the test
name(s)/LOINC code(s), specimen number, type of QC material, lot number, control level/type
(i.e., “normal,” high, low), and expiration date.
5.1.2 Use of Patient Specimens as QC Material
Patient specimens may provide useful QC information in two ways: 1) as sources for “random replicates,”
and 2) as contributors to “cumulative mean values.”
5.1.2.1 A random replicate is a patient specimen that is selected randomly from the daily workload for
use as a QC specimen. It is analyzed repeatedly over time and the results used to monitor test
reproducibility. When the observed differences between replicate results exceed user-defined
rejection criteria, corrective action should be taken. The central system should accept the
results of random duplicate specimens, recognize them as QC data and, on the basis of their
values, classify them into the appropriate QC warning statuses listed in Section 7.4.
5.1.2.2 The cumulative mean values of the results of several patients for a given analyte may be
calculated over intervals of time. If the means from different time intervals are derived from a
sufficient sample size, it may be useful to compare them statistically. Assuming that there are
no differences in the patient populations comprising the means, statistically significant
differences between those means indicate that a change in the analytic system has occurred.
User-defined rejection criteria for the size of the observed differences between means may be
established to indicate the necessity for corrective action. The central system should be able to
recognize and accept cumulative patient means and, on the basis of their values, display the
appropriate warning categories as listed in Section 7.4. The analytic instruments, LIS, or LAS
may provide mathematical enhancements to the mean values, such as elimination of extreme
values or weighting the mean values in favor of more recent results.
c
tables.

Number 4 NCCLS
5.1.3 Types of QC Messages Accepted by the System
5.1.3.1 The types of QC messages accepted by the system include the following:
• QC messages sent in the same format as patient results using the QC ID number instead of a
patient ID number. The central system (LAS) should accept these QC results even though no
"order" for this QC performance was sent from the process control system to the analyzer.
• QC messages sent as a pass/fail result.
• QC messages sent as a pass/fail result with a rule name.
• QC messages sent as a text message that indicates the reason(s) for the QC failure.
5.2 Participation in the QC Process by the Laboratory Automation System
5.2.1 The LAS should recognize and appropriately transmit/receive QC results to/from the LIS or other
appropriate information systems.
5.2.2 The LAS should dynamically inform the LAS operator of a QC failure and certain types of QC warnings.
5.2.3 The LAS should recommend a series of options for the operator to invoke that consider the
specific analyte and the QC rule(s) being applied.
5.2.4 The LAS should close down or bypass the instrument and/or specimen processing/handling
device, a module within an instrument and/or specimen processing/handling device, or an
individual assay channel in response to a QC failure.
5.2.5 The LAS should identify which specimen container(s) need to be re-assayed after an instrument
or specimen processing/handling device is repaired, or other corrective measures that have been
taken in response to a QC failure. In some cases, national or regional regulations require that no
patient results be reported until corrective action has been taken.

Volume 21 AUTO4-A
Part II: Laboratory Automation System (LAS) Status
6 Assumptions
The NCCLS Subcommittee on Communications with Automated Systems has defined a set of
transactions using the format developed by Health Level Seven (HL7), an ANSI-approved healthcare
organization creating standards for the communication of events, status, and other information, between
health-related information systems. This effort has resulted in NCCLS document AUTO3? Laboratory
Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and
Information Systems. The Subcommittee on Communications with Automated Systems has worked
closely with the Subcommittee on System Status to define many of the requirements for the
communication of status and events that relate to an LAS.
6.1 LAS Configuration
Specimens in carriers may be transferred from the LAS to instruments and/or specimen
processing/handling devices, and/or from the devices to the LAS through a standard connection between
the transportation system and devices. Four other NCCLS subcommittees have developed standards for
specimen carriers, specimen containers, specimen container labeling, information technology interface
issues, and the interface between the automation system hardware components. Please refer to the
interrelated set of NCCLS documents AUTO1— Laboratory Automation: Specimen Container/Specimen
Carrier; AUTO2--- Laboratory Automation: Bar Codes for Specimen Container Identification ;
———
AUTO3---Laboratory Automation: Communications with Automated Clinical Laboratory Systems,

Instruments, Devices, and Information Systems ; and AUTO5—Laboratory Automation:
Electromechanical Interfaces in addition to this document.
7 Status of Critical LAS Parameters
The LAS itself, as well as its component instruments and/or specimen processing/handling devices,
should be capable of self-diagnosis with reporting of events/errors. The following is a glossary of
essential LAS parameters with recommended error-level classifications.
7.1 Instrument and LAS Diagnostics
In the event that the LAS or one of its components (an instrument or a specimen processing/handling
device) is partially or completely inoperative, the instrument and/or specimen processing/handling
device/LAS diagnostics will communicate the device, cause, and severity of the problem. Interactions that
have occurred automatically and/or actions that should be taken by the operator are to be provided by the
LAS. c
The detailed information about the instrument’s and/or specimen processing/handling device’s LAS
diagnostics will differ from device-to-device as well as among LASs. The messages which describe the
error states and the necessary interactions should be transmitted in a text format. The description of the
error state (i.e., the information which defines how severely the instrument and/or specimen
processing/handling device or LAS has been impaired) should be described in a standard manner.
c
tables.

Number 4 NCCLS
7.1.1 The following classifications of the error levels are suggested for the instruments and/or specimen
processing/handling devices/LAS. These error levels are summarized into four “alert levels”
presented in Table 1.
Table 1. Alert Levels

C Critical alert: Shut down the component, fix problem, re -initialize
Level 1 The LAS component has completely stopped.
S Serious alert: Corrective action required
Level 2 The instrument and/or specimen processing/handling device/LAS is continuing
but with limited performance.
Level 3 The instrument and/or specimen processing/handling device/LAS is continuing
with limited or full performance but will discontinue when the ongoing
determinations are completed.
W Warning alert: The need for corrective action is anticipated
Level 4 A minor error has occurred in the instrument and/or specimen
processing/handling device/LAS; the results might be flagged. However, the
operator may ignore them based on the specifics of the error.
Level 5 A minor error has occurred in the instrument and/or specimen
processing/handling device/LAS. The operator may ignore them, because no
inconvenience is expected.
N Normal status: No corrective action is needed or anticipated
Level 6 The instrument and/or specimen processing/handling device is operating
normally.
Refer to NCCLS document AUTO3 for defined equipment parameters and error states.c
7.1.2 Equipment State. Specifically coded value table. See suggested values defined below.c
Table 2. Equipment State *

Value Description
PU Powered up
IN Initializing
ID Idle
CO Configuring
OP Normal operation
CL Clearing
PA Pausing
PD Paused
ES E-stopped
(null) No state change
*This table is based on LECIS.

Volume 21 AUTO4-A
7.1.3 Local/remote state. Specifically coded value table. See suggested values defined below.c
Table 3. Local/Remote States*

Value Description
L Local
R Remote
(null) No state change
*This table is based on LECIS.

7.2 Inventory
Inventory of the resources in the LAS and attached instruments and/or specimen processing/handling
devices is a critical informational element. A shortage of the necessary resources may result in the
instrument’s and/or specimen processing/handling device’s interruption of the ongoing operation and
require operator intervention. Many instruments and/or specimen processing/handling devices have
“continuous loading capability” features which preclude this event, i.e., the operator can supply resources
and discard wastes while the instrument and/or specimen processing/handling device continues to
function. If the resource can be “renewed”/”refilled” by the system itself (which is usually the case for
pressure and vacuum), it is not an inventory item, but part of system status. Inventory items are those that
can only be “refilled” by an external entity, e.g., operator.
The following are some common examples of instrument and/or specimen processing/handling device
resources:
• test-specific reagents;
• nontest-specific reagents, like buffer solution or cleaning solution;
• disposable items, such as reaction vessels, pipette tips, containers, etc.;

• paper, for result printing;
• system gases (e.g., reference gases for the blood gas analysis);
• vacuum (if not renewed by the system itself);
• batteries;
• supplemental power supply, for those instruments and/or specimen processing/handling devices
which are equipped with batteries for emergency cases such as a power failure;
• liquid waste container volumes/status; and
• solid waste container volumes/status.
Waste containers can be “inventory” measured by the available capacity remaining for waste. Thus,
when the inventory amount of a liquid waste container drops to zero, it must be emptied.
c
tables.

Number 4 NCCLS
7.2.1 The inventory information can be transmitted to the process control component of the LAS in one
of several different formats, together with a message that prompts the operator. The information
to be transmitted should be described in a standardized context such as: “if the inventory reaches
zero, an alert message must be generated.”
Table 4. Amount/Duration of Remaining Inventory Resource
Level 1 The number of remaining assay determinations or processes possible until the instrument
and/or specimen processing/handling device is unable to perform its tasks.
Level 2 The remaining time until a potential failure to perform assays occurs.
Level 3 The remaining volume of reagent in one of the units.
7.2.2 The following classification of the inventory levels should be the most suitable for the automated
laboratory systems/instruments and/or specimen processing/handling devices. They are to be
defined corresponding to each resource. c
Table 5. Interpretation of Inventory Level
Level 1 No amount is left.

Level 2 The remaining amount is not sufficient and the operation is about to stop.
Level 3 The remaining amount is not sufficient for accepting new orders, but the operation is still
running in a normal manner and committed orders will be performed.
Level 4 The remaining amount is sufficient.
The information about quantity of inventory items should include:
• the initial quantity;

• the current quantity (i.e., initial quantity minus what has been actually used);
• the available quantity (current quantity minus any planned consumption); and
• the consumption quantity (quantity used each time the equipment uses this inventory item).
Refer to NCCLS document AUTO3 for defining the inventory. Sequences have been defined to identify
the particular substance, volume or quantity, first used and expiration dates, and manufacturer
information. Also included is the usage of QC and calibration types and error identifiers.c
7.2.3 Reagent/QC Material/Substance Status. Specifically coded and user-defined coded value table.
See suggested values defined below. c
c
tables.

Volume 21 AUTO4-A
Table 6. Substance Status
Value Description
EW Expired warning
EE Expired error
CW Calibration warning
CE Calibration error
QW QC warning
QE QC error
NW Not available warning (after reaching predefined threshold)
NE Not available error
OW Other warning
OE Other error
OK OK status
7.2.4 Reagent/Material/Substance Type. Specifically coded and user-defined coded value table. See
suggested values defined below. c
Table 7. Substance Type
Value Description
SR Single-test reagent
MR Multiple -test reagent (consumption cannot be tied to orders for single test)
DI Diluent
PT Pretreatment
RC Reagent calibrator
CO Control
DW Distilled water
LW Liquid waste
SW Solid waste
SC Countable solid item (e.g., tip, etc.)
LI Measurable liquid item
OT Other
7.3 Test/Process Names and Calibration
Test/process names should be represented as LOINC codes, rather than by a proprietary manufacturer-
specific coding system.
The test/process names and calibration information can be transmitted to the LAS for each parameter in
the following manner:
The information to be transmitted should be described in a standardized context. This information is a

combination of what has been specified in the initial instrument and/or specimen processing/handling
c
tables.

Number 4 NCCLS
device setup regarding the individual tests that can be run; calibration information transmitted from the
instrument and/or specimen processing/handling device to the LAS; and the LAS’s capabilities of
interpreting information relating to the calibration of the instrument and/or specimen processing/handling
device.
• Test/process availability: whether a specific instrument and/or specimen processing/handling device

can perform a specific assay and whether the instrument and/or specimen processing/handling device
is currently formatted to perform that assay. (This “test availability” does not consider the availability
of an instrument and/or specimen processing/handling device resources [inventory items]).
• Test/process capacity: the number of any specific assay/process that an instrument and/or specimen
processing/handling device can perform based on the quantity of reagents and other required
resources currently available.
• Time to run test/process: the average amount of time required to perform a specific type of
assay/process.
• Last calibration: time/date and pass/fail status of the last calibration.
• Time until next calibration: the length of time until the next scheduled calibration automatically takes
place or the next calibration is carried out.
Refer to NCCLS document AUTO3 for defined calibration and test parameters. c This segment identifies
the assays that can run on a particular instrument and/or specimen processing/handling device, codes,
dilution qualities, reference ranges, units, and the species to which the assay applies.
7.4 Quality Control (QC)
The following classification of the QC error states should be the most suitable for the LAS and the
instruments and/or specimen processing and handling devices. They are to be defined corresponding to
each parameter.
Table 8. Quality Control Error States*
Level 1 Fatal errors have taken place

Level 2 Questionable errors have taken place
Level 3 Acceptable performance
* See suggested values defined in Section 7.2
Refer to NCCLS document AUTO3 for defined quality control error conditions. c
8 Status of Availability to External Action
The system operator will need to know the availability of the different LAS components for further
action. Tables are presented in NCCLS document AUTO3--- Laboratory Automation: Communications
with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems with
recommended categories. Status changes from instruments and/or specimen processing and handling
devices should be provided as they occur, and the current status should be available in a request mode.
c
tables.

Volume 21 AUTO4-A
The LECIS standard identifies various states that are used by the devices that are connected to the LAS.
These states are identified and used by the LAS to input, schedule, route, analyze, and store specimens on
the LAS.
The NCCLS Subcommittee on Communications with Automated Systems has interpreted these
requirements and defined several segments in the HL7 format to perform equipment command, response,
notification, and clearing of logging information. c
9 Performance Metrics of the LAS

The LAS should be able to maintain some basic performance data to allow the operator to best manage
the LAS. Whether or not the data are maintained centrally or peripherally, numerical accounting of
several aspects of the LAS’s performance should be available upon command, on-line and in summary
form. The format may be determined by the operator in consultation with the manufacturer. The
following is a glossary of these performance metrics along with brief definitions.
9.1 Monitor Results
The LAS will monitor the status of every critical component, as well as the status and location of each
specimen during the process.
9.2 Rate and Speed
The rates of performance of the LAS, as well as its individual instruments and/or specimen
processing/handling devices and other components, are to be available on command and in summary
form. From this information, the operator will be aided in determining the capacity of the currently
running LAS and the need to add or subtract LAS components. The operator will also have an estimate of
the analytical turnaround time for any single determination.
Examples of metrics include:
• turnaround time (minimum, maximum, average) for an operation on incoming specimen (container,
carrier);
• throughput (minimum, maximum, average) of incoming specimen operations per hour from “power-
off” to “power-off”; from “idle” to “idle”; and from “in-operation” to “in-operation”;
• time from “power-off” to “idle”; and
• application response time over communication interface (i.e., not the simple ACK/NAK of
communication protocol, but a confirmation of the application that will or will not perform required
task.)
9.3 Maintenance
Records of past, current, and future maintenance events are to be kept for a predetermined duration and
made available upon command. It is desirable that the LAS will flag preventive maintenance operations
shortly before the required interval. Information about the requirements for operating an instrument
and/or specimen processing/handling device “off-line” and then reconnecting it, as for purposes of
maintenance, should be available to the operator.

Number 4 NCCLS
9.4 Workload Analysis
A summary of past and current specimen numbers in analyses or to be analyzed by the LAS and each of
its components shall be available to the LAS operator. Thus, the operator will be able to make a direct
comparison between past and current workloads by day, shift, or other time elements as determined by the
operator and the manufacturer.
9.5 Production and Workflow
The operator should have the option of reviewing the workload against time, providing an overview of the
workflow by a workstation and/or instrument and/or specimen processing/handling device, as well as by
the LAS. The LAS should provide, at least, some elementary measurements of productivity using directly
obtained data points and conventional statistical analysis. It is desirable that these analyses be determined
by the operator in consultation with the manufacturer.
9.6 Errors and Events
A list of error and event messages will be available to the LAS operator or an inspector on command. A
log should be maintained for a predetermined time period, depending on need and regulatory
requirements. These may be maintained at other sites, but a matrix should identify those locations. In any
case, a daily log should be available for review.

Volume 21 AUTO4-A
References
1
HL7. Health Level Seven − An Application Protocol for Electronic Exchange in Healthcare
Environments, Version 2.4. Ann Arbor, MI: Health Level Seven; 2000.
2
HL7. Health Level Seven Implementation Support Guide for HL7 Standard, Version 2.4. Ann Arbor,
MI: Health Level Seven; Forthcoming.
3
ANSI X3.172-1996. Information Technology – American National Standards Dictionary of
Information Technology (ANSDIT). New York, NY: American National Standards Institute; 1996.
4
ANSI Standard X3.182-1990. Bar Code Print Quality Guidelines. New York, NY: American
National Standards Institute; 1995.
5
ASTM D966. Specification for Secondary Butyl Acetate (85-88% grade). West Conshohocken, PA:
ASTM; 1975.
6
ASTM E1013-93. Standard Terminology Relating to Computerized Systems. West Conshohocken,
PA: ASTM; 1993.
7
ASTM F149. Terminology Relating to Optical Character and Its Recognition. West Conshohocken,
PA: ASTM; 1997.
8
ASTM F1156. Terminology Relating to Product Counterfeit Protection Systems. West
Conshohocken, PA: ASTM; 1994.
9
IEEE 100. Dictionary of Electrical and Electronics Terms. Piscataway, NJ: Institute of Electrical and
Electronics Engineers, Inc.; 1996.
10
IEEE 610. Glossary of Computer Languages. Piscataway, NJ: Institute of Electrical and Electronics
Engineers, Inc.; 1993.
11
IEEE 1007. Measuring the Transmission of PCM Telecommunications Equipment, Circuits, and
Systems. Piscataway, NJ: Institute of Electrical and Electronics Engineers, Inc.; 1991.
12
ASTM E1381-95. Specification for Low-Level Protocol Messages Between Clinical Instruments and
Computer Systems. West Conshohocken, PA: ASTM; 1995.
13
ASTM E1394-97. Standard Specification for Transferring Information Between Clinical Instruments
and Computer Systems. West Conshohocken, PA: ASTM; 1997.
14
ASTM E1989-98. Laboratory Equipment Control Interface Specification (LECIS). West
Conshohocken, PA: ASTM; 1998.
15
JIS Standard X0208. 7-bit and 8-bit Double Byte Coded KANJI Sets for Information Interchange.
Tokyo, Japan: Japan Standards Association; 1997.

Number 4 NCCLS
NCCLS consensus procedures include an appeals process that is described in detail in Section 9.0 of
the Administrative Procedures. For further information, contact the Executive Offices or visit our
website at www.nccls.org.
Summary of Comments and Subcommittee Responses
AUTO4-P: Laboratory Automation: Systems Operational Requirements, Characteristics, and

Information Elements; Proposed Standard
Section 3, Definitions
1. Comments were received requesting additional terms be added to the Definitions section.
• The definitions section is a ‘common glossary of terms’ consistently applied to all five of the
NCCLS interrelated automation standards: AUTO1, AUTO2, AUTO3, AUTO4, and AUTO5.
These te rms were developed by each of the respective subcommittees, and then reviewed by the
area committee to develop a single resource section. The subcommittees welcomed new terms
throughout the development process that would make the standards more useful and valuable.
The most recent additions to Section 3 include Audit Trail, Device, Instrument, Inventory, and
Process Control. The area committee continues to oversee and evaluate the development of this
collection of definitions.
2. A comment was received requesting clarification on some of the current terms listed in the
Definitions section.
(a) Automation system − This is a vague definition. It is not clear what elements are minimally
necessary to constitute a ‘system.’ That definition may be unnecessary.
• The subcommittee believes that this is the best definition, at this time, in the evolution of the
automation industry. The definitions in this document may be refined in the future.
(b) Clinical laboratory automation − This is an extremely vague definition. The same definition
might apply to TQM, for example.
(c) Clinical laboratory automation system(s) −Is it necessary to have separate definitions for this
and ‘Laboratory automated system’ in this standard which is oriented toward clinical testing?
• The subcommittee states that these terms are important for the collection of the five
interrelated automation standards and considered laboratory automation vernacular.
(d) Directions of the specimen − In Figure 1 it should be made clearer that the X-axis is the primary
direction of the sample movement, but that samples typically move in the Z-axis for various
processes at individual stations, and that samples may even move in the Y-axis. As it stands,
Figure 1 implies that samples cannot move in the Y-axis. All of this appears in text, but clearer
labeling would help.
• Further clarification of Figure 1 is not an ‘easy fix.’ Figure 1 was developed with the
intention of focusing on the X and Z directions. The Y direction is defined later in the
document under a separate bullet. The subcommittee has reviewed the Y direction of

Volume 21 AUTO4-A
Figure 1 and restated that the Y direction, which is the lateral movement, is a difficult area
to standardize, and most people do not deal with it.
(e) ENQ – Communication phase is used without any definition. I am not sure what it is. The same
phrase appears in the definition of EOT.
• Refer to HL7 (e.g., Version 2.4) or ASTM (e.g., LECIS) for an appropriate definition of
“Communication phase.”
(f) High-level protocol − What is meant by the word ‘systems’?
• ‘Systems’ refers to the device and software on one or both ends of the communication line.
(g) Location − I suggest that the phrase be "laboratory location" to denote that it is not limited to
location on the analyzer itself.
• The subcommittee prefers to not change the definition of ‘Location’ at this time.
(h) Observer request − Define ‘segment.’
• The subcommittee does not believe that ‘segment’ needs to be defined. Refer to the related
documents, HL7 Version 2.4,*,† or NCCLS standard AUTO3—Laboratory Automation:
Communications with Automated Systems, Instruments, Devices, and Information Systems for
a complete understanding of the subject.
(i) Open-container sampling − Is this intended to refer only to sampling from primary tubes, or could
it also apply to aliquot tubes, filled either manually or automatically?
• The subcommittee believes that the definition for the ‘Open-container sampling’ is clear as
stated. It does not exclude nor specify the manner of specimen manipulation. The
specimen can be from eithe r manually- or automatically-filled primary or aliquot tubes.
(j) Placer − Is this definition limited to the test orderer, or could it also apply making a query about
the test results?
• This is a service on a server. A placer has nothing to do with the laboratory tests. It was
developed for placing an action.
(k) Point of reference − I am confused. Is there one distinct point of reference for an entire LAS, or
are there multiple points of reference? Does each tube serve as its own point of reference?
• The Point of Reference (POR) is only related to the instrument or device on the track in the
form of a work cell. Refer to the interrelated NCCLS standard AUTO5—Laboratory
Automation: Electromechanical Interfaces for more information on the POR.
*
HL7. Health Level Seven − An Application Protocol for Electronic Exchange in Healthcare Environments, Version 2.4. Ann
Arbor, MI: Health Level Seven; 2000.
†
HL7. Health Level Seven Implementation Support Guide for HL7 Standard, Version 2.4. Ann Arbor, MI: Health Level Seven;
Forthcoming.

Number 4 NCCLS
(l) Robotic arm − The significance of the phrase ‘Unless this device is an integral part of the LAS
system, it is considered an instrument for the purpose of this proposed standard.’ What is it then
considered if it IS an integral component?
• The subcommittee is trying to differentiate between an ‘add-on’ to an instrument and an

‘integral component’ of the instrument such as current robotic arm attachments to
instruments.
Section 5
3. In Section 5.2.5, under Performance of Quality Control Tasks, you might consider noting that CLIA
is requiring that no patient results be reported until corrective action has been taken.
• NCCLS’s general practice is to avoid such national references in documents intended for global
applications. Moreover, the subcommittee has pointed out that AUTO4 is primarily intended
for use in system design rather than laboratory practice. The text in Section 5.2.5 has been
revised by adding the following sentence, “In some cases, national or regional regulations
require that no patient results be reported until corrective action has been taken.”

Volume 21 AUTO4-A
Related NCCLS Publications *
AUTO1 Laboratory Automation: Specimen Container/Specimen Carrier. This document

contains standards for design and manufacture of specimen containers and specimen
carriers used for collection and processing of specimens, such as blood and urine, for
testing on laboratory automation systems.
AUTO2 Laboratory Automation: Bar Codes for Specimen Container Identification. This
document provides specifications for use of linear bar codes on specimen containers 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. This document provides
standards to facilitate accurate and timely electronic exchange of data and information
between the automated laboratory elements.
AUTO5 Laboratory Automation: Electromechanical Interfaces. This document provides

guidance for the standardization of electromechanical interfaces between instruments
and/or specimen processing and handling devices and automation systems in the
automated laboratory.
GP2-A2-C NCCLS Procedure Manual Template. This computer template enables laboratorians to
prepare consistent technical procedures in the NCCLS format. The template and its user
manual, used along with the GP2-A3 guideline, provide a procedure format that is as easy
to use as a word processing program. Procedures can be stored as individual files for
easy retrieval and updating, or they can be networked through the local computer system
for electronic distribution throughout the laboratory. The template format consists of
tables for recording essential information for all procedures and an outline of key
headings for incorporating procedure-specific details.
GP2-A3 Clinical Laboratory Technical Procedure Manuals – Third Edition; Approved

Guideline (1996). This document provides guidance for the patient-testing community
by addressing the design, preparation, maintenance, and use of paper or electronic
technical procedure manuals.
GP18-A Laboratory Design; Approved Guideline (1998). This guideline provides a foundation
of information about laboratory design elements that can be used to help define the issues
being considered when designing a laboratory.
GP19-A Laboratory Instruments and Data Management Systems: Design of Software User
Interfaces and End-User Software Systems Validation, Operation, and Monitoring;
Approved Guideline (1995). 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 simple rules to help prepare
validation protocols for assessing the functionality and dependability of software.
*
Proposed- and tentative-level documents are being advanced through the NCCLS consensus process; therefore, readers should refer to the most
recent editions.

Number 4 NCCLS
Related NCCLS Publications (Continued)
H18-A2 Procedures for the Handling and Processing of Blood Specimens; Approved
Guideline —Second Edition (1999). This guideline addresses multiple factors
associated with handling and processing of specimens, and factors that can introduce
imprecision or systematic bias into results.
H38-P Calibration and Quality Control of Automated Hematology Analyzers; Proposed

Standard (1999). This document addresses calibration and quality control strategies for
multichannel hematology analyzers; assignment of values to calibrator materials;
calibration using stabilized blood controls; internal quality control; pair difference
analysis; and use of the weighted moving average ( x B) method.
M29-A Protection of Laboratory Workers from Instrument Biohazards and Infectious

Disease Transmitted by Blood, Body Fluids, and Tissue; Approved Guideline (1997).
A consolidation of M29-T2 and I17-P, this document provides guidance on the risk of
transmission of hepatitis viruses and human immunodeficiency viruses in any laboratory
setting; specific precautions for preventing the laboratory transmission of blood-borne
infection from laboratory instruments and materials; and recommendations for the
management of blood-borne exposure.
NRSCL8 -A Terminology and Definitions for Use in NCCLS Documents; Approved Standard
(1998). This document provides standard definitions for use in NCCLS standards and
guidelines, and for submitting candidate reference methods and materials to the National
Reference Systems for the Clinical Laboratory (NRSCL).

Volume 21 AUTO4-A
NOTES

Number 4 NCCLS
NOTES

Volume 21 AUTO4-A
NOTES

Number 4 NCCLS
NOTES

Volume 21 AUTO4-A
NOTES

Number 4 NCCLS
NOTES

NCCLS...
Serving the World’s Medical Science Community Through Voluntary Consensus
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standards-developing, and educational organization that first stage of review by the healthcare community as a
promotes the development and use of voluntary consensus proposed standard or guideline. The document should
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is recognized worldwide for the application of its unique overall review of its scope, approach, and utility, and a line-
consensus process in the development of standards and by-line review of its technical and editorial content.
guidelines for patient testing and related healthcare issues.
Tentative A tentative standard or guideline is made
NCCLS is based on the principle that consensus is an
available for review and comment only when a
effective and cost-effective way to improve patient testing
recommended method has a well-defined need for a field
and healthcare services.
evaluation or when a recommended protocol requires that
In addition to developing and promoting the use of voluntary specific data be collected. It should be reviewed to ensure its
consensus standards and guidelines, NCCLS provides an utility.
open and unbiased forum to address critical issues affecting
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the quality of patient testing and health care.
consensus within the healthcare community. It should be
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An NCCLS document is published as a standard, guideline,
earlier versions have been satisfactorily addressed), and to
or committee report.
identify the need for additional consensus documents.
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process that clearly identifies specific, essential requirements
opinion on good practices and reflect the substantial
for materials, methods, or practices for use in an unmodified
agreement by materially affected, competent, and interested
form. A standard may, in addition, contain discretionary
parties obtained by following NCCLS’s established
elements, which are clearly identified.
consensus procedures. Provisions in NCCLS standards and
Guideline A document developed through the consensus guidelines may be more or less stringent than applicable
process describing criteria for a general operating practice, regulations. Consequently, conformance to this voluntary
procedure, or material for voluntary use. A guideline may be consensus document does not relieve the user of
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Report A document that has not been subjected to COMMENTS
consensus review and is released by the Board of Directors.
The comments of users are essential to the consensus
CONSENSUS PROCESS process. Anyone may submit a comment, and all comments
are addressed, according to the consensus process, by the
The NCCLS voluntary consensus process is a protocol
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• the authorization of a project published at the next consensus level and those that do not
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• the development and open review of documents appendix to the document. Readers are strongly encouraged
• the revision of documents in response to comments by to comment in any form and at any time on any NCCLS
users document. Address comments to the NCCLS Executive
Offices, 940 West Valley Road, Suite 1400, Wayne, PA
• the acceptance of a document as a consensus standard or 19087, USA.
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Most NCCLS documents are subject to two levels of
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AUTO4-A Replaces AUTO4-P

Vol. 21 No. 4 Vol. 19 No. 22

NCCLS gratefully acknowledges the following sponsors of this project:

American Association for Clinical Chemistry (AACC) Labotix

Chiron Diagnostics Corporation Pharmacia & Upjohn

Clinical Laboratory Management Association (CLMA) Quest Diagnostics

College of American Pathologists (CAP) Roche Diagnostics, Inc.

Compunet Clinical Labs SMS

CRS Robotics Sanofi Pasteur Diagnostics

Dade Behring Inc. SmithKline Beecham Clinical Labs

Dean Medical Center Sysmex Corporation (TOA)

Duke University Tecan

Enterprise Analysis Corporation Trillium GmbH

Food and Drug Administration (FDA) Triple G Corporation

HBO & Company UMD of New Jersey University Hospital

Hartford Hospital University Hospitals Lab Services Foundation

Hitachi Instruments, Inc. University of Nebraska Medical Center

Kaiser Permanente Wuesthoff Health Systems

Konelab Corporation Wellmont Health Systems

LAB-InterLink York Hospital

Laboratory Automation: Systems Operational Requirements,

NCCLS document AUTO4-A—Laboratory Automation: Systems Operational Requirements,

NCCLS. Laboratory Automation: Systems Operational Requirements, Characteristics, and Information

Reproduced with permission, from NCCLS publication AUTO4-A—Laboratory

Copyright ©2001. The National Committee for Clinical Laboratory Standards.

(NCCLS. Laboratory Automation: Systems Operational Requirements, Characteristics, and Information

Area Committee on Automation

Rodney S. Markin, M.D., Ph.D. University of Nebraska Medical Center

Paul J. Mountain, M.Sc., M.T.(ASCP) MDS Laboratories

Subcommittee on System Status

Russell H. Tomar, M.D. Cook County Hospital

Raymond D. Aller, M.D. MDS Lab Services (US)

Charles F. Arkin, M.D. Boston University Medical Center

John F. Boje LAB-InterLink, Inc.

Andrzej J. Knafel, Ph.D. Roche Diagnostics

James E. Myrick, Ph.D. Centers for Disease Control and Prevention

Jutaro Tadano, M.D., Ph.D. Saga Medical School

Ryuji Tao Hitachi, Ltd. Instruments

Michael G. Bissell, M.D., Ph.D. Ohio State University

Martin Burri Roche Diagnostics

James Callaghan FDA Ctr. for Devices/Rad. Health

Michael Campanelli Bayer Corporation

Alex Ciraco MDS Autolab

Natalie Ortoli Drew, M.T.(ASCP) Yale New Haven Hospital

Jane du Preez A.I. Scientific

Charles D. Hawker, Ph.D. ARUP Laboratories, Inc.

Masayoshi Hayashi Sysmex Corporation

Hendrik J. Keesom Ortho-Clinical Diagnostics

Brad Kowalski Marshfield Laboratories

Gary W. Kramer, Ph.D. National Institute of Stds. & Technology

Kam Lo Abbott Laboratories

John C. Mazza Dade Behring Inc.

David O'Bryan, Ph.D. Hibernia Consulting

Willem Stokdijk BD Immunocytometry Systems

Stuart D. Wills Beckman Coulter, Inc.

Charles F. Galanaugh Becton Dickinson and Company (Retired)

Marc R. Schlank, M.T.(ASCP), M.S. NCCLS

Patrice E. Polgar NCCLS

Donna M. Wilhelm NCCLS

Bayer Corporation – Middletown, Instrumentation Laboratory Sysmex Corporation (Japan)