Clsi HS4 A

HS4-A
Vol. 22 No. 23
Replaces HS4-P
Vol. 20 No. 11
Application of a Quality System Model for Respiratory Services;
Approved Guideline
This document provides a model for providers of respiratory services that will assist with implementation
and maintenance of an effective quality system.
A guideline for global application developed through the NCCLS consensus process.
NCCLS...
Serving the World’s Medical Science Community Through Voluntary Consensus
NCCLS is an international, interdisciplinary, nonprofit, the need for field evaluation or data collection, documents
standards-developing, and educational organization that may also be made available for review at an intermediate
promotes the development and use of voluntary (i.e., “tentative”) consensus level.
consensus standards and guidelines within the healthcare
Proposed An NCCLS consensus document undergoes the
community. It is recognized worldwide for the
first stage of review by the healthcare community as a
application of its unique consensus process in the
proposed standard or guideline. The document should
development of standards and guidelines for patient
receive a wide and thorough technical review, including an
testing and related healthcare issues. NCCLS is based on
overall review of its scope, approach, and utility, and a line-
the principle that consensus is an effective and cost-
by-line review of its technical and editorial content.
effective way to improve patient testing and healthcare
services. Tentative A tentative standard or guideline is made
available for review and comment only when a
In addition to developing and promoting the use of
recommended method has a well-defined need for a field
voluntary consensus standards and guidelines, NCCLS
evaluation or when a recommended protocol requires that
provides an open and unbiased forum to address critical
specific data be collected. It should be reviewed to ensure its
issues affecting the quality of patient testing and health
utility.
care.
Approved An approved standard or guideline has achieved
PUBLICATIONS
consensus within the healthcare community. It should be
An NCCLS document is published as a standard, reviewed to assess the utility of the final document, to
guideline, or committee report. ensure attainment of consensus (i.e., that comments on
earlier versions have been satisfactorily addressed), and to
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guidelines may be more or less stringent than applicable
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Report A document that has not been subjected to
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Volume 22 HS4-A

Approved Guideline
Abstract
NCCLS document HS4-A—Application of a Quality System Model for Respiratory Services; Approved
Guideline provides the necessary background information and infrastructure to develop a quality system
that will meet healthcare quality objectives and be consistent with the quality objectives of each
institution. This guideline provides a structure for a comprehensive, systematic approach to build quality
into the respiratory service’s processes, assess its performance, and implement quality improvements.
Individual service areas, such as respiratory therapeutics, pulmonary diagnostics, or sleep diagnostics can
apply this model to their respective operations. To provide a practical example of how a quality system is
developed and implemented for respiratory services, suggestions for the pulmonary diagnostic laboratory
and respiratory therapeutics are included.
NCCLS. Application of a Quality System Model for Respiratory Services; Approved Guideline. NCCLS
document HS4-A (ISBN 1-56238-476-7). NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2002.
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
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Number 23 NCCLS
ii
HS4-A
ISBN 1-56238-476-7
ISSN 0273-3099
Approved Guideline
Volume 22 Number 23
Susan Blonshine, B.S., RRT, RPFT, FAARC
Carl R. Mottram, B.A., RRT, RPFT
Karen J. Stewart, M.S., RRT
Marta Tingdale, BCA, RRT, R.N.
Number 23 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 professional
practice 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 HS4-A—Application of a Quality

System Model for Respiratory Services; Approved Guideline (ISBN 1-56238-476-7).
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 ©2002. The National Committee for Clinical Laboratory Standards.
Suggested Citation
(NCCLS. Application of a Quality System Model for Respiratory Services; Approved Guideline. NCCLS
document HS4-A [ISBN 1-56238-476-7]. NCCLS, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2002.)
Proposed Guideline
May 2000
Approved Guideline
November 2002
ISBN 1-56238-476-7
ISSN 0273-3099
iv
Volume 22 HS4-A
Committee Membership
Area Committee on Healthcare Services
Kathleen J. Sazama, M.D., J.D. University of Texas

Chairholder Houston, Texas
Judy Dye, M.A. University of Arizona Medical Center

Vice-Chairholder Tucson, Arizona
Bernard M. Branson, M.D. Centers for Disease Control and Prevention

Atlanta, Georgia
James B. Conway Dana-Farber Cancer Institute

Boston, Massachusetts
Barbara M. Goldsmith, Ph.D. Alliance Laboratory, Inc.

Cincinnati, Ohio
Jeffrey S. Johnson, M.S. Spectrum Health

Grand Rapids, Michigan
Jeannie Miller, R.N., BSN Centers for Medicare and Medicaid Services
Baltimore, Maryland
Carl R. Mottram, BA, RRT, RPFT, FAARC Mayo Clinic

Rochester, Minnesota
Robert Wise, M.D. JCAHO

Oakbrook Terrace, Illinois
Advisors
Susan Blonshine, BS, RRT, RPFT, FAARC, AE-C TechEd Consultants

Mason, Michigan
Jonathan S. Krauss, M.D. Medical College of Georgia Hospitals and Clinics

Augusta, Georgia
Robert McNamee Dianon Systems, Inc.

Stratford, Connecticut
George Pounds, C.L.S., M.T.(ASCP) Quest Diagnostics, Incorporated

San Juan Capistrano, California
Jennifer K. McGeary, M.T.(ASCP), M.S.H.A. NCCLS

Staff Liaison Wayne, Pennsylvania
Patrice E. Polgar NCCLS

Editor Wayne, Pennsylvania
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Number 23 NCCLS
Donna M. Wilhelm NCCLS

Assistant Editor Wayne, Pennsylvania
Acknowledgements
NCCLS gratefully acknowledges the experts and institutions listed below for their help in preparing the
approved-level edition of this guideline.
Susan Blonshine, B.S., RRT, RPFT, FAARC, AE-C – TechEd Consultants

Carl R. Mottram, B.A., RRT, RPFT, FAARC – Mayo Clinic
Karen J. Stewart, M.S., RRT – Charleston Area Medical Center
Marta Tingdale, BCA, RRT, RN – Baylor University Medical Center
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Volume 22 HS4-A
Active Membership
(as of 1 October 2002)
Sustaining Members College of Physicians and Deutsches Institut für Normung

Surgeons of Saskatchewan (DIN)
Abbott Laboratories ESCMID FDA Center for Devices and
American Association for Fundación Bioquímica Argentina Radiological Health
Clinical Chemistry International Association of Medical FDA Center for Veterinary
Beckman Coulter, Inc. Laboratory Technologists Medicine
BD and Company International Council for FDA Division of Anti-Infective
bioMérieux, Inc. Standardization in Haematology Drug Products
CLMA International Federation of Iowa State Hygienic Laboratory
College of American Pathologists Clinical Chemistry Massachusetts Department of
GlaxoSmithKline Italian Society of Clinical Public Health Laboratories
Nippon Becton Dickinson Co., Ltd. Biochemistry and Clinical National Center of Infectious
Ortho-Clinical Diagnostics, Inc. Molecular Biology and Parasitic Diseases (Bulgaria)
Pfizer Inc Japan Society of Clinical Chemistry National Health Laboratory Service
Roche Diagnostics, Inc. Japanese Committee for Clinical (South Africa)
Laboratory Standards National Institute of Standards
Professional Members Joint Commission on Accreditation and Technology
of Healthcare Organizations New York State Department of
AISAR-Associazione Italiana per lo National Academy of Clinical Health
Studio degli Biochemistry Ohio Department of Health
American Academy of Family National Association of Testing Ontario Ministry of Health
Physicians Authorities – Australia Pennsylvania Dept. of Health
American Association for National Society for Saskatchewan Health-Provincial
Clinical Chemistry Histotechnology, Inc. Laboratory
American Association for Ontario Medical Association Scientific Institute of Public Health;
Respiratory Care Quality Management Program- Belgium Ministry of Social
American Chemical Society Laboratory Service Affairs, Public Health and the
American Medical Technologists RCPA Quality Assurance Programs Environment
American Public Health Association PTY Limited Swedish Institute for Infectious
American Society for Clinical Sociedade Brasileira de Analises Disease Control
Laboratory Science Clinicas Thailand Department of Medical
American Society of Hematology Sociedad Espanola de Bioquimica Sciences
American Society for Microbiology Clinica y Patologia Molecular
American Type Culture Taiwanese Committee for Clinical Industry Members
Collection, Inc. Laboratory Standards (TCCLS)
Asociacion Mexicana de Turkish Society of Microbiology AB Biodisk
Bioquimica Clinica A.C. Abbott Laboratories
Assn. of Public Health Laboratories Government Members Abbott Laboratories, MediSense
Assoc. Micro. Clinici Italiani- Products
A.M.C.L.I. Association of Public Health Acrometrix Corporation
British Society for Antimicrobial Laboratories Alifax S.P.A.
Chemotherapy Armed Forces Institute of Pathology Ammirati Regulatory Consulting
CADIME-Camara De Instituciones BC Centre for Disease Control Anaerobe Systems
De Diagnostico Medico Centers for Disease Control and Asséssor
Canadian Society for Medical Prevention AstraZeneca
Laboratory Science—Société Centers for Medicare & Medicaid AstraZeneca R & D
Canadienne de Science de Services/CLIA Program Boston
Laboratoire Médical Centers for Medicare & Medicaid Avant Immunotherapeutics, Inc.
Clinical Laboratory Management Services Aventis
Association Chinese Committee for Clinical Axis-Shield POC AS
COLA Laboratory Standards Bayer Corporation – Elkhart, IN
College of American Pathologists Commonwealth of Pennsylvania Bayer Corporation – Tarrytown, NY
College of Medical Laboratory Bureau of Laboratories Bayer Corporation – West Haven,
Technologists of Ontario Department of Veterans Affairs CT
Bayer Medical Ltd.
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Number 23 NCCLS
BD EXPERTech Associates, Inc. Radiometer Medical A/S

BD Biosciences – San Jose, CA F. Hoffman-La Roche AG Replidyne
BD Consumer Products Fort Dodge Animal Health Roche Diagnostics GmbH
BD Diagnostic Systems General Hospital Vienna (Austria) Roche Diagnostics, Inc.
BD Italia S.P.A. Gen-Probe Roche Laboratories (Div.
BD VACUTAINER Systems GlaxoSmithKline Hoffmann-La Roche Inc.)
Beckman Coulter, Inc. Greiner Bio-One Inc. Sarstedt, Inc.
Beckman Coulter, Inc. Primary Care Helena Laboratories SARL Laboratoire Carron (France)
Diagnostics Home Diagnostics, Inc. Schering Corporation
Beckman Coulter K.K. (Japan) IGEN Inc. Schleicher & Schuell, Inc.
Bio-Development SRL Immunicon Corporation Second Opinion
Bio-Inova Life Sciences Instrumentation Laboratory Showa Yakuhin Kako Company,
International International Technidyne Ltd.
Bio-Inova Life Sciences North Corporation Streck Laboratories, Inc.
America IntraBiotics Pharmaceuticals, Inc. SurroMed, Inc.
BioMedia Laboratories Sdn Bhd I-STAT Corporation Synermed Diagnostic Corp.
BioMérieux (NC) Johnson and Johnson Pharmaceutical Sysmex Corporation (Japan)
bioMérieux, Inc. (MO) Research and Development, L.L.C. Sysmex Corporation
Biometrology Consultants Kendall Sherwood-Davis & Geck (Long Grove, IL)
Bio-Rad Laboratories, Inc. LAB-Interlink, Inc. The Clinical Microbiology Institute
Bio-Rad Laboratories, Inc. - France Laboratory Specialists, Inc. The Toledo Hospital (OH)
Biotest AG Labtest Diagnostica S.A. Theravance Inc.
Blaine Healthcare Associates, Inc. LifeScan, Inc. (a Johnson & Transasia Engineers
Bristol-Myers Squibb Company Johnson Company) Trek Diagnostic Systems, Inc.
Canadian External Quality Lilly Research Laboratories Versicor, Inc.
Assessment Laboratory Macemon Consultants Vetoquinol S.A.
Capital Management Consulting, Medical Device Consultants, Inc. Visible Genetics, Inc.
Inc. Merck & Company, Inc. Vysis, Inc.
Carl Schaper Minigrip/Zip-Pak Wallac Oy
Checkpoint Development Inc. Molecular Diagnostics, Inc. Wyeth-Ayerst
Chiron Corporation mvi Sciences (MA) Xyletech Systems, Inc.
ChromaVision Medical Systems, Nabi YD Consultant
Inc. Nichols Institute Diagnostics YD Diagnostics (Seoul, Korea)
Chronolab Ag (Div. of Quest Diagnostics, Inc.)
Clinical Design Group Inc. NimbleGen Systems, Inc. Trade Associations
Clinical Laboratory Improvement Nissui Pharmaceutical Co., Ltd.
Consultants Nippon Becton Dickinson Co., Ltd. AdvaMed
Cognigen Norfolk Associates, Inc. Association of Medical
Community Medical Center (NJ) Novartis Pharmaceuticals Diagnostic Manufacturers
Control Lab (Brazil) Corporation Japan Association Clinical
Copan Diagnostics Inc. Ortho-Clinical Diagnostics, Inc. Reagents Ind. (Tokyo, Japan)
Cosmetic Ingredient Review (Raritan, NJ) Medical Industry Association
Cubist Pharmaceuticals Ortho-Clinical Diagnostics, Inc. of Australia
Dade Behring Inc. - Deerfield, IL (Rochester, NY)
Dade Behring Inc. - Glasgow, DE Oxoid Inc. Associate Active Members
Dade Behring Inc. - Marburg, Paratek Pharmaceuticals
Germany Pfizer Inc 31st Medical Group/SGSL (APO,
Dade Behring Inc. - Sacramento, CA Pharmacia Corporation AE)
Dade Behring Inc. - San Jose, CA Philips Medical Systems 67th CSH Wuerzburg, GE (NY)
David G. Rhoads Associates, Inc. Powers Consulting Services 121st General Hospital (CA)
Diagnostics Consultancy Premier Inc. Academisch Ziekenhuis-VUB
Diagnostic Products Corporation Procter & Gamble (Belgium)
Eiken Chemical Company, Ltd. Pharmaceuticals, Inc. Acadiana Medical Laboratories,
Elan Pharmaceuticals The Product Development Group LTD (LA)
Electa Lab s.r.l. QSE Consulting Adena Regional Medical Center
Enterprise Analysis Corporation Quintiles, Inc. (OH)
Essential Therapeutics, Inc. Radiometer America, Inc. Advocate Healthcare Lutheran
General (IL)
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Volume 22 HS4-A
Akershus Central Hospital and AFA Clendo Lab (Puerto Rico) Hahnemann University Hospital
(Norway) Clinical Laboratory Partners, LLC (PA)
Albemarle Hospital (NC) (CT) Harris Methodist Erath County
Allegheny General Hospital (PA) CLSI Laboratories (PA) (TX)
Allina Health System (MN) Columbia Regional Hospital (MO) Harris Methodist Fort Worth (TX)
Alton Ochsner Medical Commonwealth of Kentucky Hartford Hospital (CT)
Foundation (LA) Community Hospital of Lancaster Headwaters Health Authority
Antwerp University Hospital (PA) (Alberta, Canada)
(Belgium) CompuNet Clinical Laboratories Health Network Lab (PA)
Arkansas Department of Health (OH) Health Partners Laboratories (VA)
ARUP at University Hospital (UT) Cook County Hospital (IL) Heartland Regional Medical Center
Armed Forces Research Institute of Cook Children’s Medical Center (MO)
Medical Science (APO, AP) (TX) Highlands Regional Medical Center
Associated Regional & Covance Central Laboratory (FL)
University Pathologists (UT) Services (IN) Hoag Memorial Hospital
Aurora Consolidated Danish Veterinary Laboratory Presbyterian (CA)
Laboratories (WI) (Denmark) Holmes Regional Medical Center
Azienda Ospedale Di Lecco (Italy) Danville Regional Medical Center (FL)
Bay Medical Center (MI) (VA) Holzer Medical Center (OH)
Baystate Medical Center (MA) Delaware Public Health Laboratory Hopital du Sacre-Coeur de
Bbaguas Duzen Laboratories Department of Health & Montreal (Montreal, Quebec,
(Turkey) Community Services (New Canada)
Bermuda Hospitals Board Brunswick, Canada) Hôpital Maisonneuve – Rosemont
Bo Ali Hospital (Iran) DesPeres Hospital (MO) (Montreal, Canada)
Brooks Air Force Base (TX) DeTar Hospital (TX) Hospital for Sick Children
Broward General Medical Center Detroit Health Department (MI) (Toronto, ON, Canada)
(FL) Diagnosticos da América S/A Hospital Sousa Martins (Portugal)
Cadham Provincial Laboratory (Brazil) Hotel Dieu Hospital (Windsor, ON,
Calgary Laboratory Services Dr. Everett Chalmers Hospital Canada)
Carilion Consolidated Laboratory (New Brunswick, Canada) Houston Medical Center (GA)
(VA) Doctors Hospital (Bahamas) Huddinge University Hospital
Cathay General Hospital (Taiwan) Duke University Medical Center (Sweden)
Central Peninsula General Hospital (NC) Hurley Medical Center (MI)
(AK) Dwight David Eisenhower Army Indiana University
Central Texas Veterans Health Care Med. Ctr. (GA) Innova Fairfax Hospital (VA)
System E.A. Conway Medical Center (LA) Institute of Medical and Veterinary
Centre Hospitalier Regional del la Eastern Maine Medical Center Science (Australia)
Citadelle (Belgium) East Side Clinical Laboratory (RI) International Health Management
Centro Diagnostico Italiano Eastern Health (Vic., Australia) Associates, Inc. (IL)
(Milano, Italy) Elyria Memorial Hospital (OH) Jackson Memorial Hospital (FL)
Champlain Valley Physicians Emory University Hospital (GA) Jersey Shore Medical Center (NJ)
Hospital (NY) Esoterix Center for Infectious John C. Lincoln Hospital (AZ)
Chang Gung Memorial Hospital Disease (TX) John F. Kennedy Medical Center
(Taiwan) Fairview-University Medical (NJ)
Changi General Hospital Center (MN) John Peter Smith Hospital (TX)
(Singapore) Federal Medical Center (MN) Kadlec Medical Center (WA)
The Charlotte Hungerford Hospital Florida Hospital East Orlando Kaiser Permanente Medical Care
(CT) Focus Technologies (CA) (CA)
Children’s Hospital (LA) Foothills Hospital (Calgary, AB, Kaiser Permanente (MD)
Children’s Hospital (NE) Canada) Kantonsspital (Switzerland)
Children’s Hospital & Clinics (MN) Fresenius Medical Care/Spectra Keller Army Community Hospital
Children’s Hospital Medical Center East (NJ) (NY)
(Akron, OH) Fresno Community Hospital and Kenora-Rainy River Regional
Children’s Hospital of Medical Center Laboratory Program (Ontario,
Philadelphia (PA) Frye Regional Medical Center (NC) Canada)
Children’s Medical Center of Dallas Gambro BCT (CO) Kern Medical Center (CA)
(TX) Geisinger Medical Center (PA) Kimball Medical Center (NJ)
Clarian Health–Methodist Hospital Grady Memorial Hospital (GA) King Faisal Specialist Hospital
(IN) Guthrie Clinic Laboratories (PA) (Saudi Arabia)
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Number 23 NCCLS
King Khalid National Guard Montreal Children’s Hospital Reid Hospital & Health Care
Hospital (Saudi Arabia) (Canada) Services (IN)
King’s Daughter Medical Center Montreal General Hospital Research Medical Center (MO)
(KY) (Canada) Rex Healthcare (NC)
Klinični Center (Slovenia) MRL Pharmaceutical Services, Inc. Rhode Island Department of Health
Laboratories at Bonfils (CO) (VA) Laboratories
Laboratoire de Santé Publique du Nassau County Medical Center Riyadh Armed Forces Hospital
Quebec (Canada) (NY) (Saudi Arabia)
Laboratório Fleury S/C Ltda. National Institutes of Health (MD) Royal Columbian Hospital (New
(Brazil) Naval Hospital – Corpus Christi Westminster, BC, Canada)
Laboratory Corporation of America (TX) Sacred Heart Hospital (MD)
(NJ) Naval Surface Warfare Center (IN) Saint Mary’s Regional Medical
Laboratory Corporation of Nebraska Health System Center (NV)
America (MO) New Britain General Hospital (CT) St. Alexius Medical Center (ND)
LAC and USC Healthcare New England Fertility Institute St. Anthony Hospital (CO)
Network (CA) (CT) St. Anthony’s Hospital (FL)
Lakeland Regional Medical Center New Mexico VA Health Care St. Barnabas Medical Center (NJ)
(FL) System St-Eustache Hospital (Quebec,
Lancaster General Hospital (PA) New York University Medical Canada)
Langley Air Force Base (VA) Center St. Francis Medical Ctr. (CA)
LeBonheur Children’s North Carolina State Laboratory of St. John Hospital and Medical
Medical Center (TN) Public Health Center (MI)
L'Hotel-Dieu de Quebec (Canada) North Shore – Long Island Jewish St. John Regional Hospital (St.
Libero Instituto Univ. Campus Health System Laboratories (NY) John, NB, Canada)
BioMedico (Italy) North Shore University Hospital St. Joseph Hospital (NE)
Louisiana State University (NY) St. Joseph’s Hospital – Marshfield
Medical Center Northwestern Memorial Hospital Clinic (WI)
Maccabi Medical Care and Health (IL) St. Joseph's Medical Center (NY)
Fund (Israel) O.L. Vrouwziekenhuis (Belgium) St. Joseph Mercy Hospital (MI)
Malcolm Grow USAF Medical Ordre professionnel des St. Jude Children's Research
Center (MD) technologists médicaux du Hospital (TN)
Martin Luther King/Drew Medical Québec St. Luke’s Regional Medical
Center (CA) Ospedali Riuniti (Italy) Center (IA)
Massachusetts General Hospital The Ottawa Hospital St. Mary of the Plains Hospital
(Microbiology Laboratory) (Ottawa, ON, Canada) (TX)
MDS Metro Laboratory Services Our Lady of Lourdes Hospital (NJ) St. Mary’s Hospital & Medical
(Burnaby, BC, Canada) Our Lady of the Resurrection Center (CO)
Medical College of Virginia Medical Center (IL) St. Vincent Medical Center (CA)
Hospital Pathology and Cytology Ste. Justine Hospital (Montreal, PQ,
Medicare/Medicaid Certification, Laboratories, Inc. (KY) Canada)
State of North Carolina Pathology Associates Medical Salina Regional Health Center (KS)
Memorial Hospital at Gulfport (MS) Laboratories (WA) San Francisco General Hospital
Memorial Medical Center (IL) The Permanente Medical Group (CA)
Memorial Medical Center (LA) (CA) Santa Clara Valley Medical Center
Jefferson Davis Hwy Piedmont Hospital (GA) (CA)
Memorial Medical Center (LA) Pikeville Methodist Hospital (KY) Seoul Nat’l University Hospital
Napoleon Avenue Pocono Hospital (PA) (Korea)
Mercy Medical Center (IA) Presbyterian Hospital of Dallas Shanghai Center for the
Methodist Hospital (TX) (TX) Clinical Laboratory (China)
Methodist Hospitals of Memphis Providence Health Care South Bend Medical Foundation
(TN) Queen Elizabeth Hospital (Prince (IN)
MetroHealth Medical Center (OH) Edward Island, Canada) Southwest Texas Methodist Hospital
Michigan Department of Queensland Health Pathology (TX)
Community Health Services (Australia) South Western Area Pathology
Mississippi Baptist Medical Center Quest Diagnostics Incorporated Service (Australia)
Monte Tabor – Centro Italo - (CA) Southern Maine Medical Center
Brazileiro de Promocao (Brazil) Quintiles Laboratories, Ltd. (GA) Specialty Laboratories, Inc. (CA)
Regions Hospital Stanford Hospital and Clinics (CA)
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Volume 22 HS4-A
State of Washington Department of University of Alabama-Birmingham VA Outpatient Clinic (OH)

Health Hospital Vejle Hospital (Denmark)
Stony Brook University Hospital University of Alberta Hospitals Washington Adventist Hospital
(NY) (Canada) (MD)
Stormont-Vail Regional Medical University of Colorado Health Washoe Medical Center
Center (KS) Science Center Laboratory (NV)
Sun Health-Boswell Hospital (AZ) University of Chicago Hospitals West Jefferson Medical Center
Swedish Medical Center – (IL) (LA)
Providence Campus (WA) University of Illinois Medical Center West Shore Medical Center (MI)
Tampa General Hospital (FL) University of the Ryukyus (Japan) Wilford Hall Medical Center (TX)
Temple University Hospital (PA) University of Texas M.D. Anderson William Beaumont Army Medical
Tenet Odessa Regional Hospital Cancer Center Center (TX)
(TX) University of Virginia Medical William Beaumont Hospital (MI)
The Toledo Hospital (OH) Center William Osler Health Centre
Touro Infirmary (LA) University of Washington (Brampton, ON, Canada)
Trident Regional Medical Center UZ-KUL Medical Center (Belgium) Williamsburg Community Hospital
(SC) VA (Denver) Medical Center (CO) (VA)
Tripler Army Medical Center (HI) Virginia Department of Health Winn Army Community Hospital
Truman Medical Center (MO) VA (Hines) Medical Center (GA)
UCSF Medical Center (CA) VA (Kansas City) Medical Center Winnipeg Regional Health
UNC Hospitals (NC) (MO) Authority (Winnipeg, Canada)
University College Hospital VA (Western NY) Healthcare Wishard Memorial Hospital (IN)
(Galway, Ireland) System Yonsei University College of
University Hospital (Gent) VA (San Diego) Medical Center Medicine (Korea)
(Belgium) (CA) York Hospital (PA)
University Hospitals of Cleveland VA (Tuskegee) Medical Center
(OH) (AL)
The University Hospitals (OK)
OFFICERS BOARD OF DIRECTORS
Donna M. Meyer, Ph.D., Susan Blonshine, RRT, RPFT, Tadashi Kawai, M.D., Ph.D.
President FAARC International Clinical Pathology
CHRISTUS Health TechEd Center
Thomas L. Hearn, Ph.D., Wayne Brinster J. Stephen Kroger, M.D., MACP

President Elect BD COLA
Centers for Disease Control and
Prevention Kurt H. Davis, FCSMLS, CAE Willie E. May, Ph.D
Canadian Society for Medical National Institute of Standards and
Emil Voelkert, Ph.D., Laboratory Science Technology
Secretary
Roche Diagnostics GmbH Lillian J. Gill, M.S. Gary L. Myers, Ph.D.
FDA Center for Devices and Centers for Disease Control and
Gerald A. Hoeltge, M.D., Radiological Health Prevention
Treasurer
The Cleveland Clinic Foundation Robert L. Habig, Ph.D. Barbara G. Painter, Ph.D.
Habig Consulting Group Pharma Micro Consultancy, LLC
F. Alan Andersen, Ph.D.,
Immediate Past President Carolyn D. Jones, J.D., M.P.H. Judith A. Yost, M.A., M.T.(ASCP)
Cosmetic Ingredient Review AdvaMed Centers for Medicare & Medicaid
Services
John V. Bergen, Ph.D.,
Executive Director
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Volume 22 HS4-A
Contents
Abstract ....................................................................................................................................................i
Committee Membership..........................................................................................................................v
Active Membership.............................................................................................................................. vii
Foreword ...............................................................................................................................................xv
1 Introduction................................................................................................................................1
2 Scope..........................................................................................................................................2
3 Definitions .................................................................................................................................2
4 Introduction to the Path of Workflow ........................................................................................4
5 Path of Workflow.......................................................................................................................4
5.1 Pulmonary Diagnostics..................................................................................................4
5.2 Respiratory Therapeutics...............................................................................................6
5.3 Integration of Therapeutic and Diagnostic Paths of Workflow.....................................8
5.4 Application of Path of Workflow Across the Continuum of Care ..............................10
6 Application of Quality System Essentials (QSEs) to Respiratory Care Services ....................11
6.1 QSE: Documents and Records ....................................................................................11
6.2 QSE: Organization.......................................................................................................15
6.3 QSE: Personnel............................................................................................................16
6.4 QSE: Equipment ..........................................................................................................19
6.5 QSE: Purchasing and Inventory ..................................................................................20
6.6 QSE: Process Control ..................................................................................................21
6.7 QSE: Information Management...................................................................................33
6.8 QSE: Occurrence Management ...................................................................................33
6.9 QSE: Assessment........................................................................................................37
6.10 QSE: Process Improvement.........................................................................................38
6.11 QSE: Service and Satisfaction.....................................................................................38
6.12 QSE: Facilities and Safety ...........................................................................................39
References.............................................................................................................................................40
Appendix A. Examples of Pulmonary Function (PF) Laboratory Quality Indicators by

Operating System ...........................................................................................................43
Appendix B. Published Laboratory Quality Indicators (Applicable to the Arterial Blood

Gas Laboratory) Grouped by Laboratory Operating System and QSE..........................44
Appendix C. Examples of Respiratory Services Quality Indicators for Operating Systems ................45
Summary of Comments and Working Group Responses .....................................................................46
Related NCCLS Publications................................................................................................................47
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Volume 22 HS4-A
Foreword
In the present environment of limited resources, it is expected by those who fund, provide, and receive
healthcare services that quality is integral. This document defines a model for those who provide
respiratory services that will assist organizations with implementation and maintenance of an effective
quality system.
This model is consistent with the example provided by the International Organization for Standardization
(ISO) for quality standards in business and industry, though the terminology and concepts used are more
familiar to the healthcare entities.
The model for respiratory services is an application of NCCLS document HS1— Quality System Model
for Health Care. A working knowledge of HS1 is needed to apply the concepts presented in this
document.
Synthesizing the concepts of acknowledged quality experts,1,2 a hierarchy defining stages of quality3,4 is
described in the table below.
State Activities Performed

Total Quality Management approach centered on quality, aimed at long-term
Management success through customer satisfaction.
Quality Management Includes the stages below and also the economic aspects of
“cost of quality.”
Quality System Comprehensive and coordinated efforts to meet quality

objectives.
Quality Assurance Planned and systematic activities to provide confidence that an

organization fulfills requirements for quality.
Quality Control Operational techniques to fulfill requirements for quality and

regulatory compliance.
Similar to Maslow’s hierarchy of personal needs,5 an organization can best obtain the next-higher stage
by mastery of the preceding one.
In most of the world, healthcare services are operating at or below the stages of quality control and
quality assurance. Although some healthcare services are working successfully at the level of quality
systems needed, it is becoming more apparent that healthcare organizations need to upgrade their quality
activities to include quality systems. This document provides guidance to achieve the quality system level
in the quality hierarchy as applied in respiratory services. (See shaded grid above.) The baseline of a
quality system, with operations under control, provides a platform for continuous improvement and
further movement up the quality hierarchy.
An integrated quality system provides an opportunity to deliver consistent, high quality, and cost-
effective health care in any healthcare organization. In healthcare service areas where regulatory and
accreditation compliance applies, a quality system will simplify the process. The model described in this
document provides guidance for developing a quality system in healthcare settings providing respiratory
services.
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Number 23 NCCLS
Readers will also find the information in NCCLS documents HS1—A Quality System Model for Health
Care and GP22—Continuous Quality Improvement: Essential Management Approaches to be valuable
resources.
Key Words
Quality, quality indicators, quality system
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Volume 22 HS4-A

Approved Guideline
1 Introduction
HS4 is one document in a quality series designed for healthcare service managers who wish to improve
their programs through quality management activities. This companion document provides specific
guidance for the application of the quality system model to respiratory services. This guideline is intended
to be used together with the comprehensive program of quality improvement described in NCCLS
publication HS1—A Quality System Model for Health Care. These guidelines provide users with a
complementary set of quality system resources designed to assist any healthcare organization in
establishing or fortifying its quality system infrastructure.
The structure described in this document is for a quality system in respiratory services as described in
detail in NCCLS document HS1—A Quality System Model for Health Care and is adaptable to any
service in a healthcare organization. NCCLS HS1 stems from guidance originally provided to the U.S.
blood banking community.6-9
For the purposes of the quality system model described in this guideline, quality system essentials (QSEs)
are:
• Organization
• Personnel
• Equipment
• Purchasing and inventory
• Process control
• Documents and records
• Occurrence management
• Internal assessment
• Process improvement
• Service and satisfaction
• Information Management
• Facilities and Safety
Concurrently with the development of the rudiments of a quality system for blood banking, there has also
been a growing awareness of the existence of the international guidance for quality being used in the
manufacturing and service industries. International guidance is documented as the ISO 9000 family of
quality standards.10 The subcommittee has considered the following documents in the drafting of this
guideline: ISO 9001:1994 Quality Systems — Model for quality assurance in design, development,
production, installation and servicing11; ISO/DIS 15189, Quality management in the clinical laboratory
12
; and ISO/IEC DIS 17025, General requirements for the competence of testing and calibration
laboratories,13; ISO 9004:2000, Quality management systems—Guidelines for performance
improvements.14 The quality system described in ISO 900111 defines 20 quality system elements that any
business should use to manage its operations. NCCLS document HS1 — A Quality System Model for
Health Care contains tables that depict the relationship between the twelve quality system essentials
described in the model and the 20 quality elements used internationally in business and industry.
An NCCLS global consensus guideline. ©NCCLS. All rights reserved. 1

Number 23 NCCLS
2 Scope
The quality system model described in this guideline is based on NCCLS Document HS1—A Quality
System Model for Health Care and is applied to respiratory services. The quality system essentials are
universal and thus can be applied to any service’s operations, whether simple or complex.
3 Definitionsa
Accident - An undesirable or unfortunate happening that occurs unintentionally.
Audit - A planned, independent, and documented assessment to determine whether agreed-upon

requirements are being met (American Society for Quality (ASQ), Quality Audit Division15).
Calibration - The set of operations that establishes, under specified conditions, the relationship between
values of quantities indicated by a measuring instrument or measuring system, or values represented by a
material measure or a reference material, and the corresponding values realized by standards (VIM93-
6.1116).
Competence - The ability of an individual to perform a specific job or task.
Contract review - Defined activities carried out before entering into a contract agreement to ensure that
requirements are adequately defined and understood, and can be achieved (ISO 8402, 3.1017).
Corrective action - Action taken to eliminate the cause(s) of existing problems, defects, or any other
undesirable situation in order to prevent recurrence (ISO 8402, 4.1417).
Critical control points, CCPs - Groupings of related activities and tasks that must be accomplished
effectively to minimize errors in operational processes.
Customer - The recipient of a product or service provided by the supplier (ISO 8402, 1.917).
Document - Any written item of a factual or informative nature.
Error - A deviation from truth, accuracy, or correctness; a mistake.
Form - A paper or electronic document on which information or results are captured; NOTE: Once
completed, a form becomes a record.
Incident - An individual occurrence or event.
Key elements, KEs - The activities and tasks within a critical control point.
Medical error - Any preventable event that may cause or lead to inappropriate medication use or patient
harm while the medication is in control of the health care professional, patient, or consumer. Such events
may be related to professional practice, health care product, procedures and systems, including
prescribing; order communication; education; monitoring; and use.18
Occurrence - Something that happens; an event, incident.
a
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 guideline. ©NCCLS. All rights reserved.

Volume 22 HS4-A
Policy - A written statement of overall intentions and directions defined by those in the organization and
endorsed by management (AABB19).
Preventive action - Action taken to eliminate the cause(s) of potential problems, defects, or any other
undesirable situation in order to prevent occurrence (ISO 8402, 4.1317).
Preventive maintenance - Scheduled periodic work on a piece of equipment that is not a result of
malfunction or failure and is intended to avert such failure.
Procedure - A specified way to perform an activity (ISO 8402, 1.3117).
Process - One or more interrelated resources and/or activities that transform inputs (e.g. intent, policies)
into outputs (e.g., instruction, procedures) (ISO 8402, 1.217).
Proficiency testing/External quality assessment/PT//EQA - A program in which multiple specimens

are periodically sent to members of a group of laboratories for analysis and/or identification; whereby
each laboratory’s results are compared with those of other laboratories in the group and/or with an
assigned value, and reported to the participating laboratory and others.
Quality - The totality of characteristics of an entity that bear on its ability to satisfy stated and implied
needs (ISO 8402, 2.117).
Quality assurance - Planned and systematic activities to provide adequate confidence that requirements
for quality will be met (ISO 8402, 3.517).
Quality control - Operational techniques and activities that are used to fulfill requirements for quality
(ISO 8402, 3.417).
Quality management - All activities of the overall management function that determine quality policy
objectives and responsibilities; and implement them by means such as quality planning, quality control,
quality assurance; and quality improvement within the quality system (ISO 8402, 3.217).
Quality policy - Overall intentions and direction of an organization with regard to quality (e.g., quality
system essentials) as formally expressed by top management (ISO 8402, 3.117).
Quality system - The organizational structure, resources, processes, and procedures needed to implement
quality management (ISO 8402, 3.617).
Record - A document that furnishes objective evidence of information obtained, activities performed, or
results achieved (ISO 8402, 3.1517).
Service - The result generated by activities at the interface between the provider and the customer and by
provider’s internal activities to meet the customer needs (ISO 8402, 1.517).
Statistical tools - Methods and techniques used to generate, analyze, interpret, and present data.
Supplier - An organization that provides a product or service to the customer (ISO 8402, 1.1017).
Traceability - 1) A property of the result of a measurement or the value of a standard whereby it can be
related to stated references, usually national or international standards, through an unbroken chain of
comparisons, all having stated uncertainties (VIM93-6.10); 2) The ability to trace the history, application,
or location of an entity by means of recorded identifications (ISO 8402, 3.1617).

Number 23 NCCLS
Validation - Action [or process] of proving that a procedure, process, system, equipment, or method used
works as expected and achieves the intended result (ISO 8402, 2.1817).
Verification - The confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled (ISO 8402, 2.1717).
4 Introduction to the Path of Workflow

In healthcare organizations, there are multiple units providing various services. Each of these units can
apply the organization’s quality systems to their operational activities. Mapping these unit activities
creates a “path of workflow” to accomplish the assigned tasks. The path of workflow describes the
operational aspects that define how a particular service or product is provided. ISO 9000 describes this
concept as the “process model.” It represents the sequence of activities from the initiation of a request for
the healthcare service’s products or services through the provision of those products or services, and any
necessary follow-up. The activities may cross functional boundaries.
5 Path of Workflow
5.1 Pulmonary Diagnostics
Pretest Testing Session Post-test
Patient Assessment Patient Training Results Report

Test Request Test Performance Interpretation
Patient Preparation Results Review/
Equipment Preparation Information Gathering
Figure 1. Path of Workflow for Pulmonary Diagnostics. Adapted from NCCLS document HS1—A
Quality System Model for Health Care.
QSEs apply to all operations across the path of workflow. The operating systems in the path of workflow
are shown within the structure in Figure 1.
5.1.1 Pretest Phase
Elements of the pretest phase include:
Patient Assessment
• clinical history
• patient signs and symptoms
Volume 22 HS4-A
• other indicators that guide the physician or practitioner to make recommendations related to
appropriate testing
• standardized ordering format may guide the process
Test Request Process
• generating the order

• patient instructions
• scheduling
• sequencing of test performance may impact test results
Patient Preparation
• specific demographic and history information from the patient (e.g., questionnaires, height and
weight)
• assessing patient compliance with pretest instructions
• verifying the clinical indication or contraindications for testing
• consent forms when appropriate
Equipment Preparation
• calibration and gathering equipment and supplies

• selection of reference values
5.1.2 Testing Session
The testing session should include the following elements:
Patient Training
• procedure explanation and demonstration
Test Performance
• according to best clinical practice guidelines20-32

• patient understanding and ability to perform the test
• recognition of equipment or test performance errors
Results Review and Selection
• conformance to laboratory, and best clinical practice guidelines20-32

• data and graphic review and selection
• therapist/technologist comments
Patient Assessment for Further Testing
• utilization of patient-driven protocols

• correlation of results with the patient’s clinical presentation
5.1.3 Post-test Phase
The post-test phase emphasizes the following:

Number 23 NCCLS
Results Report
• quality review
• report generation
Interpretation
• conformance to laboratory and best clinical practice guidelines20
Clinical Consultation
• application of results to clinical interventions

• verbal reporting
5.2 Respiratory Therapeutics
Preanalytical Analytical Postanalytical
Patient Assessment Evaluation of Data Gathering Institution or Suggestion of

Equipment Preparation Determination of Therapeutic Goal Intervention (e.g., patient Request
for Therapeutic Equipment Preparation education)
Intevention (e.g., CPAP or Patient Preparation Outcomes Assessment (e.g.,
oxygen therapy) therapeutic goal assessment
and patient adherence)
Figure 2. Path of Workflow for Respiratory Therapeutics. Adapted from NCCLS document HS1—A
Quality System Model for Health Care.
5.2.1 Preanalytical Phase
The preanalytical phase encompasses the following elements (see Figure 2):
Information Gathering:
• chart review (e.g., advance directives, test results, physician progress notes)
• review of chest x-ray
• consultation with other care providers
Volume 22 HS4-A
Patient Assessment:
• clinical history
• patient signs and symptoms
• allergy information
• physical assessment
• standardized ordering formats and care paths (Protocols may guide the process.)
Equipment Preparation:
• calibration and gathering of equipment and supplies (e.g., peak flow meter, oximeter)
Request for Therapeutic Intervention:
• scheduling and/or sequencing of interventions
Patient Preparation:
• creating an environment for patient or significant others’ participation in the applications of

respiratory services
5.2.2 Analytical Phase
The analytical phase addresses the following elements (see Figure 2):
Evaluation of Data Gathering:
• patient assessment
• information gathering
Determination of Therapeutic Goals:
• conferencing with other providers

• clinical indications versus contraindications
• efficacy
• desired outcome
Equipment Preparation:
• calibration and gathering of equipment and supplies for therapeutic intervention
Patient Preparation:
• explain procedure to patient or significant other

• assess patient compliance
• complete consent forms, where appropriate

Number 23 NCCLS
5.2.3 Postanalytical Phase
The following elements are considered during the postanalytical phase (see Figure 2):
Institution or Suggestion of Intervention:
• conformation to best clinical practice guidelines
Outcome Assessment:
• therapeutic goal assessment

• correlation of results with patient’s clinical presentation
Clinical Consultation:
• application of results and/or clinical intervention

• verbal reporting
5.3 Integration of Therapeutic and Diagnostic Paths of Workflow
In some instances, the path of workflow that begins as one process will integrate with a second path of
workflow. This can best be illustrated looking at sleep disorder testing and treatment, as depicted in
Figure 3, on the following page.
The typical path of workflow begins as pulmonary diagnostics with the pretest requirements completed.
The movement to the testing session is the location that the path of workflow may become an integrated
path of workflow with respiratory therapeutics.
In the testing session, many sleep centers, utilizing a protocol, may initiate a split-night sleep study. The
treatment begins with the initiation of CPAP based on pre-established criteria. The patient then moves
from the pure diagnostic path to a path for therapeutic intervention. In this case, the path of workflow
will follow the respiratory therapeutic flow beginning with preanalytical stage and move to the analytical
stage. As the treatment proceeds with CPAP adjustments, the interventions will remain therapeutic. Once
the treatment criteria are established, the path of workflow reverts to the pulmonary diagnostics flow at
the post-test level, and the path is completed.

An NCCLS global consensus guideline. ©NCCLS. All rights reserved.
Volume 22
Pretest Testing Session Post-test
Patient Assessment Patient Training Results Report

Test Request Test Performance Interpretation
Patient Preparation (e.g., polysmonography)
Equipment Preparation Results Review/
Information Gathering
Therapeutic
Intervention
(e.g., split-night)
Preanalytical Analytical Postanalytical
Patient Assessment Evaluation of Data Gathering Institute or Suggest Intervention

Equipment Preparation Determination of Therapeutic Goal (e.g., patient education)
Request for Therapeutic Equipment Preparation Outcomes Assessment (e.g.,
Intervention (e.g., CPAP or Patient Preparation therapeutic goal assessment and
oxygen therapy) patient adherence)
Figure 3. Structure for an Integrated Respiratory Service Path of Workflow. Adapted from NCCLS document HS1—A
Quality System Model for Health Care
HS4-A
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Number 23 NCCLS
5.4 Application of Path of Workflow Across the Continuum of Care
An individual may enter the continuum of care at any point. Within the continuum of care, there are
multiple areas such as:
• Emergent care (e.g., ambulance services, emergency departments, emergency visits, transport);
• Acute care (e.g., hospital setting external to critical care);
• Critical care (e.g., adult intensive care units, burn units, neonatal intensive care units, pediatric
intensive care units, transport, trauma intensive care units);
• Postacute care (e.g., community care, home care, hospice, long-term care, palliative care,
pulmonary rehabilitation, SNF, subacute care);
• Wellness and prevention (e.g., community care, occupational/environmental services, pulmonary
rehabilitation, smoking cessation programs); and
• Primary care (e.g., diagnostic services, educational services, therapeutic services).
Figure 4. The Continuum of Care
The spiral depicted in Figure 4 represents the frequency of assessment and intervention by the respiratory
therapist as the patient moves through the continuum of care. As the individual moves, the frequency of
the professional assessment and intervention decreases as the patient/client ownership and ability for self-
care increases, thus requiring fewer professional assessments and interventions by the respiratory
therapist.
The ability for the decrease in professional intervention is accomplished by educating the
individual/significant others, and the assessment of their ability to implement interventions.
In a quality system, the QSEs and path of workflow for diagnostics and therapeutics apply across the
continuum of care.

Volume 22 HS4-A
6 Application of Quality System Essentials (QSEs) to Respiratory Care Services

Health care must expand its view of quality beyond the departmentalized quality control and quality
assurance activities of the last decades to keep pace with the growing role of total quality management in
today’s competitive environment. Quality systems are being used successfully in the world’s
manufacturing and service sectors, and there is reason to believe that quality systems will benefit
healthcare services as well.
Each healthcare service in an organization can use the same quality system essentials to manage its
specific path of workflow. In so doing, the healthcare organization’s management can develop one set of
policies for the quality system essentials that apply to all the services in the entire organization. The
processes and procedures for implementing the quality policies can also become more uniform and
streamlined, which removes costly discrepancies, conflicts, and struggles for limited resources among the
many services. Using the same quality system essentials for each healthcare service integrates the quality
system across the entire continuum of care.
This guideline presents a working model that will enable champions for change to take the first steps in
improving quality in healthcare services specific to respiratory services.
6.1 QSE: Documents and Records
6.1.1 Document Control
Document control is a means to ensure that only the latest version of approved documents are being used
by the staff. The respiratory service and/or laboratory should appoint someone with the vested
responsibility for overseeing the document control system. Document control includes:
• document identification (numbering/coding);

• version identification;
• revision control;
• master file;
• master index;
• distribution; and
• archiving.
6.1.1.1 Document Identification (numbering/coding)
Each service should develop a numbering system that includes all documents. The numbering system
should identify the type of document (quality policy, quality process, quality procedure, operating policy,
operating process, and operating procedure), its respective code number, and the version. The respiratory
services and/or pulmonary laboratory section may be identified in the code number. Although there is no
one correct way to code documents, a combination of alpha and numeric characters has been found to be
useful.
Example # 1: This is an example of a document identification number for a quality policy.
QP201/02
Where QP = Quality Policy
201 = Policy document number 201 (QSE #2, Personnel)
/02 = second version

Number 23 NCCLS
Example #2: This is an example of a document identification number for a test procedure used in the
pulmonary function laboratory’s testing operations.
PF525S.01
Where PF = Pulmonary Function
525 = procedure document number 525
S = Spirometry
.01 = first version
Example #3: This is an example of a document identification number for a form used in the respiratory
service department’s operations.
RC625A.02
Where RS = respiratory services
625 = procedure document number 625
A = form A for this procedure
.02 = second version
6.1.1.2 Version Identification
Version identification helps assure that only that latest approved version of a document is in use. Versions
can be identified with numbers or letters. The display of an effective date on the document, the use of
colored paper or stamps are other examples of version identification.
6.1.1.3 Revision Control
In a quality system, a formal means of revision control assures that only authorized changes are made to
approved documents, that all changes are reviewed and approved prior to being placed into use, and that
all copies of the document in use reflect the change. Deficiencies regarding documents are among the
most common cited by regulatory and accreditation agencies. The following example (see Figure 5) of a
document change request form commonly used in quality systems may assist to request changes to
approved documents. Services must also determine how changing one document could affect needed
changes in other documents and how the input of all those affected by the change will be obtained and
considered.

Volume 22 HS4-A
Change#:
DOCUMENT CHANGE REQUEST FORM
Document Name:
Document Number: Requestor:
Revision Number: Date:
DESCRIPTION OF CHANGE:
RATIONALE FOR CHANGE
RELATED PROCEDURES AFFECTED? Yes No

IF YES, LIST:
VALIDATION AFFECTED? Yes No

WHY OR WHY NOT?
SIGNATURE APPROVAL: (As defined in the document control process)
Document Author: Date:

Supervisor: Date:
Medical Director: Date:
ISSUE DATE: EFFECTIVE DATE:

End
Document number/version Facility Name/Location Page 1 of 1
Effective Date
Figure 5. Sample Document Change Request Form
6.1.1.4 Master File for a Document
Each document should have a master file that contains the current and all previous versions. Either or
both electronic and hardcopy versions of master documents can be filed. Copies of the document change
request form with review and approval signatures should also be kept in the master file. The master file
serves as the historical record of a particular document from its inception to the present and provides a
means to look back in time should there ever be a need to do so.

Number 23 NCCLS
6.1.1.5 Master Index Example
The master index illustrated in Figure 6 is a listing of all documents currently in use, functioning like an
extended table of contents of all policy, process, and procedure manuals. Whenever a document is
changed and updated to a new version, the master index should also be updated. Software applications for
personal computers, such as spreadsheets and databases, are also useful for maintaining the master index.
Master Index
Document Control Document Name Effective Date Location(s)

Number and Version
PF625S.02 Spirometry 1/15/90 PF lab/RC dept.
PF625S.03 Spirometry 2/1/95 PF lab/RC dept./Outreach

clinic/asthma center
Figure 6. Sample Master Document Index

Volume 22 HS4-A
6.1.1.6 Distribution
The document master file and index should indicate each location where active copies of a document are
placed. Document locations may be added or deleted as needed by the pulmonary laboratory/respiratory
service. The same process is applicable to electronic document formats.
6.1.1.7 Archiving
The current version of a document (policy, process description, procedure, or form) is stored in its
respective master file. When a document is changed, old working copies must be destroyed and replaced
with the new version.
Document master files must be stored in a manner to prevent loss or damage and to promote easy
retrieval. Duration of retention may be defined by regulations or accreditation requirements for
laboratories, and the organization’s business requirements.
6.1.2 Records Management
6.1.2.1 Records Review
Reviews of records should be performed according to regulations and accreditation requirements for the
respiratory service’s and or the laboratory’s own policies and procedures. Policies and procedures are
usually reviewed on an annual basis. All reviews should be documented with the review date and the
reviewer’s name/initials.
6.1.2.2 Archiving
Records must be stored in a manner to prevent loss or damage and to promote easy retrieval. The duration
of retention may be defined by regulations or accreditation requirements for laboratories and the
organization’s business requirements.
6.2 QSE: Organization
To accomplish the objective of improving operations and services to its customers, the healthcare
organization’s executive management, the respiratory services management and/or pulmonary diagnostics
laboratory management, and respective medical directors must actively support establishing and
maintaining the quality system. Visible participation of medical and administrative management in setting
quality policy, seeking customer feedback, and receiving and acting upon information derived from
quality indicators and occurrence trending is essential to the successful implementation of the quality
system for any respiratory service or pulmonary laboratory service.21,22
It is advisable to select a team composed of representatives of each section of respiratory services

(therapeutics, rehabilitation, home care, sleep) and a staff member knowledgeable in quality process to
oversee the implementation of the quality system phases. For example, in pulmonary diagnostics, a team
composed of pulmonary laboratory staff and a staff member knowledgeable in quality process may
oversee the implementation of the quality system phases. This team will assign implementation projects,
provide support, and track progress in implementing the quality system. Active participation on the part
of the management is essential to the successful implementation of the quality system.
A detailed discussion on management commitment to quality through quality planning and actualization
is included in NCCLS document GP22—Continuous Quality Improvement: Essential Management
Approaches. Readers are referred to this document for more information.

Number 23 NCCLS
6.2.1 Staff Involvement
It is necessary to include all respiratory and diagnostic staff members in the implementation of the quality
system. At a minimum, all employees should receive training on the quality system and their
responsibilities in the training, occurrence management, and data collection/indicator monitoring
processes. All staff should participate in flowcharting their respective work processes, identifying where
SOPs are needed, and recommending changes for improvement. Staff involvement in organization-wide
quality improvement teams is encouraged.
6.3 QSE: Personnel
6.3.1 Job Qualifications and Descriptions
The responsibility for specifying job qualifications and descriptions should reside within each respiratory
service and should meet recommended minimum job qualifications.21-32
6.3.2 Development and Documentation of Training and Competence Assessment Programs
Respiratory services and pulmonary laboratories should provide orientation, training, and competence
assessment to ensure good laboratory practice.21
6.3.2.1 Orientation and Training
The written policy for "QSE: Personnel" should state that it provides staff with orientation and training.
The policy should include but is not limited to:
• code of ethics;
• organizational requirements (such as those found in the organization’s employee handbook);
• respiratory or pulmonary laboratory orientation, general respiratory service requirements, and
competency assessment;
• safety training;
• computer training;
• job-specific tasks; and
• the organization’s, respiratory and/or laboratory’s quality system, the employee’s role, and the use of
continuous improvement tools and techniques.
Table 1 provides a more detailed listing of the components of a training program for the pulmonary
laboratory service.

Volume 22 HS4-A
Table 1. Components of a Training Program for the Arterial Blood Gas (ABG) and Pulmonary
Function (PF) Laboratory Service
Component Contents
Organizational knowledge Mission statement
General orientation
Conditions of employment (employee handbook)
Employee benefits
Facility tour
General safety
• Hazard communication—general
• Fire preparedness
• Disaster preparedness
Departmental knowledge Departmental mission
Area tour
Departmental terminology
Departmental rules and policies
Dress requirements
Safety
• General safety and equipment
• Blood-borne pathogens
• Hazard communication—laboratory specific
• Tuberculosis
Quality knowledge Code of ethics
Organization’s and department's quality system
Organization's problem solving approach
Department’s quality assurance program
Laboratory’s quality control program
Employee's expected roles in each of the above
Job-related knowledge Listing of SOPs that everyone in the department must
follow
• Computer access
• Record keeping
• Occurrence reporting, etc.
Listing of SOPs that persons with that job must follow
• Test procedures
• Quality control procedures
• Troubleshooting procedures, etc.
There should be a written description of the respiratory and/or laboratory’s process for training when:
• new employees are hired;

• new procedures have been implemented;
• procedures are changed;
• periodic reverification of competency is required; and when
• retraining and remediation is necessary.
The training guide should also include a plan for assessing age-specific skills.

Number 23 NCCLS
6.3.2.2 Training Guides
Training guides are useful in conveying important background information to employees and include the
rationale for particular actions in a procedure. Training guides provide instructions for both trainers and
trainees and help assure that each trainee receives the same basic information every time. Table 2 displays
sample contents for a training guide.
Table 2. Sample Contents for Training Guides
Training Guide Content Function

Current SOP Serves as outline for each procedure in the training guide.
Annotated SOP SOP with training notes inserted for use by the trainer during
demonstrations and practice.
Required reading Used by employee to define the required reading to achieve didactic
knowledge to achieve competency.
Cognitive orientation guidelines Used by employee and trainer to define the required knowledge to
achieve competency.
Learning objectives Used by employee and trainer to define the scope of training.
Direct observation checklist Used by employee for self-evaluation after practicing the SOP.
Used by the trainer to assess whether training has been successful.
Used for periodic ongoing competence assessment to assure skills
have been retained.
Used after remedial training to assure demonstration of required
skills.
Quiz or written test Questions written to assess knowledge of the procedure in areas of:
• Procedure theory
• Procedure technique
• Interpretation
• Problem solving
Training checklist Used to assure completeness of training and outcome.
Training documentation records Tracks training and competence over time.
Guidance on the preparation of training guides can be found in the most recent version of NCCLS
document GP21— Training Verification for Laboratory Personnel.
6.3.2.3 Competence Assessment
Individuals providing respiratory services should have their competence assessed initially and
periodically thereafter to determine if they have maintained and continue to demonstrate the skills for
which they were trained. Competence assessment should include the need for retraining and remediation.
Competence assessment applies to all employees, and competency expectations should be well defined.
The remediation process should be documented and quantified.33-35
6.3.2.4 Documentation of Training and Competence Assessment
All training and competence assessments must be documented. When assessments fail to meet
expectations, retraining must be initiated and documented.
The respiratory and laboratory service should develop a system to document and track employee training
and competence assessment. Documentation systems can be manual34,36 or computerized.37,38

Volume 22 HS4-A
Guidance for development of a manual documentation system for training and competence assessment
can be found in the most current edition of NCCLS document GP21—Training Verification for
Laboratory Personnel.
6.4 QSE: Equipment
6.4.1 Equipment Management Plan for Pulmonary Diagnostics
There should be a pulmonary laboratory equipment management plan so that all instruments and
equipment are properly selected, installed, calibrated, and function verified.
6.4.1.1 Equipment Selection
To ensure proper equipment selection, the management plan should include the following:
(1) Development of a list of acceptable vendors based on the defined equipment needs and required
specifications.
(2) Development of a product-evaluation matrix.39,40
(3) Evaluation of selected equipment; equipment should meet or exceed minimum
equipment performance standards.
(4) Determination of acceptable limits of accuracy and precision.
(5) Consideration of database management options.
(6) Consideration of quality control standards and ease of calibration routines.
(7) Consideration of the computer standards for the healthcare system.
(8) Identification of well-defined warranty and service agreements.
(9) Performance of an on-site evaluation of the equipment.40
(10) Comparison of test results between the old equipment and the new equipment.
6.4.1.2 Equipment Installation
There should be a plan for installing all new pieces of equipment and instrumentation to verify proper
functioning prior to reporting test results. The plan should include verifying the adequacy of the facilities
such as electricity, ventilation, temperature, and other environmental conditions. Verification activities
should be documented and the installation process should include:
• the development of an installation manual;

• equipment validation performed by the manufacturer;
• equipment validation performed by the pulmonary laboratory staff;
• biomedical safety checks performed by an internal or external biomedical department (may be
included in the preventive maintenance provided by the manufacturer); and
• validation of selected reference values by the laboratory under medical supervision (i.e., medical
director).
The laboratory should determine the requirements for calibration, quality control, maintenance, and
adjustments. Schedules for calibration, QC, and maintenance should be derived, documented, and
followed. When problems occur, there should be documented processes to follow for troubleshooting,
repair, and post repair recalibration or revalidation. The laboratory should have written SOPs for all
calibration, maintenance, quality control, and performance monitoring activities.22-29
6.4.2 Equipment Management Plan for Respiratory Therapeutics
There should be an equipment management plan so that all instruments and equipment are properly
selected, installed, calibrated, and function verified. The equipment management plan should include:
Number 23 NCCLS
6.4.2.1 Equipment Selection
(1) Develop a list of acceptable vendors based on the defined equipment needs and required
specifications.
(2) Develop a product-evaluation matrix.39,40
(3) Evaluate selected equipment; equipment should meet or exceed minimum equipment performance
standards, or other performance standards.41
(4) Determine acceptable limits of accuracy and precision.
(5) Consider database management options.
(6) Consider quality control standards and ease of calibration routines.
(7) Consider the computer standards for the healthcare system.
(8) Identify well-defined warranty and service agreements.
(9) Perform an on-site evaluation of the equipment.40
(10) Compare performance between the old equipment and the new equipment.
(11) Consider ability to update equipment software.
6.4.2.2 Equipment Installation
There should be a plan for installing all new pieces of equipment and instrumentation to verify proper
functioning prior to use. The plan should include verifying the adequacy of the facilities such as
electricity, ventilation, temperature, and other the environmental conditions. Verification activities should
be documented and the installation process should include:
• the development of an installation plan and documentation (e.g., original documents) by an

independent source or by staff;
• equipment validation performed by the manufacturer as appropriate;
• biomedical safety checks performed by an internal or external biomedical department;
• equipment validation performed by staff; and
• validation of methodology (e.g., nitric oxide, heliox) under medical supervision (i.e., medical
director).
Each respiratory service should determine the requirements for calibration, quality control, maintenance,
and adjustments based on the organization’s operational requirements and the manufacturer’s
requirements. Schedules for calibration, QC, and maintenance should be derived, documented, and
followed. When problems occur, there should be documented processes to follow for troubleshooting,
repair, and postrepair recalibration or revalidation. Each respiratory service should have written SOPs for
all calibration, maintenance, quality control, and performance monitoring activities.21,32,41
A comprehensive equipment management plan for all services should include a master list of all
equipment and instruments with respective identifying information, calibration and maintenance
schedules, and persons designated to review the plan and respective records at defined intervals.21
6.5 QSE: Purchasing and Inventory
Efficient and cost-effective respiratory, pulmonary and arterial blood gas laboratory operations need the
uninterrupted availability of supplies and services. Each service should set expectations, and build and
maintain good relationships with providers of materials and services. Services should have a process to
receive and evaluate incoming critical materials (e.g., methacholine, ABG controls, disposable vinyl
supplies) to assure that necessary requirements have been fulfilled.42

Volume 22 HS4-A
6.5.1 Purchasing
The respiratory and/or laboratory should identify critical supplies and services and define the necessary
characteristics or functional requirements for each. All products, including substitutions, must meet the
pre-established requirements. These expectations should be communicated to the respective vendors, who
are then evaluated for the ability to meet the service’s requirements. Vendor approval may be granted
based on criteria such as licensure or approval of test methods or instruments; external certification of the
vendor’s quality system (e.g., ISO 9000 series registration/certification); a review of past history with the
vendor; or any other facility-determined criteria.
Contracts to obtain critical supplies, materials, and other services should be reviewed to ensure that each
party’s expectations are defined. Any amendments or other changes should also be reviewed and
approved by both parties.
6.5.2 Inventory
The respiratory service and/or laboratory must have a process to receive incoming materials and supplies,
inspect them prior to acceptance, test them prior to use where required, and maintain an adequate
inventory.
Guidance for a laboratory inventory control system can be found in the current edition of NCCLS
document GP6— Inventory Control Systems for Laboratory Supplies.
6.6 QSE: Process Control
It is only through understanding and controlling the respiratory or pulmonary laboratory’s many processes
that it can become both more effective in meeting requirements and more efficient in the use of its costly
human and other resources.
6.6.1 Developing Flowcharts for Respiratory and Laboratory Processes
Ideally, management and staff should flowchart the process for each section of the path of workflow
specific to their institution. This can be accomplished manually or by using any of several available
software programs. Process flowcharts identify steps where SOPs are needed to complete specific tasks.
Once a process is outlined on a flowchart, problems that cause redundancies, inefficiencies, and rework
can be identified. Revised processes and procedures can then be implemented to improve or correct
performance.
Figures 7, 8, and 9 illustrate a process in the pulmonary laboratory’s path of workflow for spirometry test
result selection and reporting. This process, presented in three formats (Figure 7-Manual; Figure 8-Table;
Figure 9-Electronic), describes the responsibilities, actions, and documents needed for selection and
reporting of spirometry test results. This process lists SOPs for specific tasks that must be properly
performed for the process to be successfully accomplished.

Number 23 NCCLS
Operating Process: Spirometry Test Result Selection and Reporting
Perform spirometry, meeting acceptability and reproducibility requirements
Select largest FVC from acceptable maneuvers
Select instantaneous flows from the “best curve”
Report the highest peak flow
Print all acceptable curves
Document patient cooperation, effort, or standards not met
Verify accuracy of demographic, environmental, anthropometric data
Generate report
Verify accuracy of selected data
Enter interpretation into the operating process
Figure 7. Sample Process Description in PF Laboratory Operations: Spirometry Test Result

Selection and Reporting— Manual Flowchart Format

Volume 22 HS4-A
Operating Process: Spirometry Test Result Selection and Reporting
Purpose To describe the process for spirometry test result selection and reporting.
Process This process is supported by the steps and documents in the table that follows:
What Happens Who’s Responsible Results: Documents

1. Performs spirometry Therapist/Technologist SOPs for:
meeting ATS • Spirometry performance
acceptability and
reproducibility
criteria.24
2. Selects largest FVC from Therapist/Technologist SOPs for:

acceptable maneuvers. • Data selection
3. Selects largest FEV1 from • Selection of best curve
acceptable maneuvers.
4. Selects instantaneous
flows from the “best
curve.”
5. Selects highest peak flow.
6. Prints all acceptable Therapist/Technologist SOPs for:
curves. Data to print and maintenance
of hard copies
7. Documents patient Therapist/Technologist SOP for:
cooperation, effort, and • Report comments
standards not met. • Data entry criteria
8. Verifies accuracy of
demographics,
environmental, and
anthropometric data.
9. Verifies accuracy of
selected data.
10. Generates report. Therapist/ Technologist SOP for:
Support staff • Report generation and
entry into interpretation
process
Expected Results: Accurate and reliable test results.
Figure 8. Sample Process Description in Pulmonary Function (PF) Laboratory Operations:

Spirometry Test Result Selection and Reporting— Table Format

Number 23 NCCLS
PERFORM
SPIROMETRY
SELECT
LARGEST FVC
SELECT
LARGEST FEV1
SELECT
INSTANTANEOUS FLOWS
FROM "BEST CURVE"
SELECT HIGHEST
PEAK FLOW
DOES
NO ALL DATA
SELECTED MEET
ATS SELECTION
CRITERIA?
YES
PRINT ACCEPTABLE
CURVE
VERIFY ACCURACY
OF DATA
NO IS
DOCUMENTATION
COMPLETE?
YES
GENERATE
REPORT
Figure 9. Sample Process Description in Pulmonary Function (PF) Laboratory Operations:

Spirometry Test Result Selection and Reporting— Electronic Flowchart Format

Volume 22 HS4-A
Figures 10, 11, and 12 illustrate a process in the path of workflow for sputum induction. This process,
presented in three formats: Figure 10 (Manual); Figure 11 (Table) and Figure 12 (Electronic) describes
the responsibilities, actions, and documents needed for completion of a sputum induction protocol. This
process lists SOPs for specific tasks that must be properly performed for the process to be successfully
accomplished.
Operating Process: Sputum Induction Protocol
Physician Order
Assess Patient
Natural or Artificial Airway
Obtain Equipment
Productive Cough or Needs to be Suctioned
Instruct Patient to Brush Teeth and Rinse Mouth
Perform Induction
Specimen Obtained
Label Specimen and Take to Laboratory within 30 minutes
Figure 10. Sample Process Description for Respiratory Therapeutics: Sputum Induction Protocol—
Manual Flowchart Format

Number 23 NCCLS
Operating Process: Sputum Induction Protocol
Purpose To describe the process for obtaining and selecting the method to perform a
sputum induction.
Process The steps and documents in the table that follows support this process:
What Happens Who’s Responsible Results: Documents

1. Physician writes order Physician SOPs for:
for sputum induction. • Physician order sheet.
2. Assesses patient. Therapist SOPs for:

3. Determines whether • Patient assessment.
patient has natural or • Sputum induction.
artificial airway. • Equipment stock and
4. Chooses equipment location.
appropriate for
patient condition.
5. Determine whether Therapist SOPs for:

patient has • Suctioning.
productive cough or • Patient hygiene.
needs to be
suctioned.
6. Have patient brush
teeth and rinse
mouth.
7. Perform induction. Therapist SOPs for:
8. Obtain specimen in • OSHA standards.
sterile container. • Infection control
standards.
• Use of personal
protective equipment.
9. Label specimen and Therapist/Transporter SOPs for:
take to laboratory • Transport of specimen.
within 30 minutes of • Documentation policy.
specimen
acquisition.
Expected Results: Quality sputum specimen that provides diagnostic information.
Table Format

Volume 22 HS4-A
PHYSICIAN
PROCURE ORDER A
ORDER
No
Yes
PRODUCTIVE
COUGH OR
ASSESS PATIENT SUCTIONED
NATURAL OR
ARTIFICIAL PERFORM
AIRWAY INDUCTION
OBTAIN SPECIMEN
CHOOSE
IN STERILE
APPROPRIATE
CONTAINER
EQUIPMENT
INSTRUCT TO LABEL SPECIMEN

BRUSH TEETH AND AND TAKE TO
RINSE MOUTH LABORATORY
WITHIN 30 MINUTES
Electronic Flowchart Format

Number 23 NCCLS
6.6.2 Process Validation
Validation consists of a plan for personnel to challenge and document the results of new or modified
processes or procedures to assure personnel that the processes or procedures work as expected in clinical
application before actual implementation.42,43 Whenever a change is necessary, the new process or
procedure should be validated to assure that the results will continue to meet clinical needs and
expectations, and those of its customers. When developing the operating SOPs to be used in the process,
those for calibration, maintenance, and QC must also be included. A sample validation protocol is
outlined below.
Process Validation Checklist
(Attach documentation to support the following activities)
I. Purpose of Validation
II. Description of the System to be Validated
III. Responsibilities
A. Installation qualification
1. Performed by
2. Reviewed by
B. Maintenance and calibration
C. Support services provided by
D. Validation
1. Performed by
2. Reviewed by
IV. Validation Protocol
A. Requirements
1. SOPs to be used
2. Personnel to perform
3. Equipment needed
4. Material to be used
B. Test samples required
C. Testing conditions to be used
D. Data to be collected
E. Acceptance criteria
F. Protocol
1. Prepared by
2. Reviewed by
3. Approved by
V. Conclusion
A. Validation results
B. Comments/actions
C. Signatures
1. Performed by
2. Approved by
3. Medical director review
4. Quality function review
D. Results acceptable?
1. Yes or no
2. Comments
Volume 22 HS4-A
6.6.3 Identifying and Writing Standard Operating Procedures (SOPs)
There should be written SOPs for critical steps in the quality system essentials.21 There should also be
SOPs for critical steps in the respiratory therapeutics or laboratory’s processes in each operating system
throughout the entire path of workflow. As mentioned previously, the respiratory services and pulmonary
laboratory staff should collaborate with other healthcare providers that impact the path of workflow.
Example: For tests performed for an office practice the laboratory may wish to consider providing patient
instruction and order forms.
Example: Scheduling delivery of therapy within the context of the patient’s daily care plan.
Guidance for which procedures to develop for the QSE is given in the “Procedure” column of the tables in
Section 7.2 of NCCLS document HS1—A Quality System Model for Health Care. The current edition of
NCCLS document GP2—Clinical Laboratory Technical Procedure Manuals provides a template for
technical procedure formatting.
SOPs should be easy to read, use, and follow, as shown in the example in Figure 13.

Number 23 NCCLS
Identifying the Patient for Specimen Collection Effective Date: mm/dd/yy

Document # / version #
Identifying the Patient for Specimen Collection
Purpose This procedure provides instructions for correctly identifying patients for specimen
collection.
Policy • A patient’s name and a second identifier (e.g., medical record number or date of
birth) are required.
• Exceptions are not allowed.
Supplies Patient identification band (see example in Appendix 1)
Procedure A: Follow the steps in the table below to properly identify inpatients.
Inpatients
Step Action
1 Ask the patient to state his or her last name when able.
2 Verify that the patient is wearing an identification band.
3 Follow the directions in the table below for identifying the patient.
If: Then:
there is no ID band • do not proceed, and
anywhere in the room, • notify the patient’s nurse.
Note:
During disasters or codes, refer to the
emergency identification procedure.
the ID band is attached • do not proceed
to the bed, • ask the patient’s nurse to identify the patient,
and
• ask the nurse to document the verification on
the collection list, labels, or requisition.
the ID band is present • do not proceed, and
but not attached to the • notify the patient’s nurse.
patient,
4 Match the ID band to the requisition, collection list, or labels.
5 Proceed with specimen collection only when patient identification is
verified.
Continued on next page
Anytown Hospital Laboratory, Anytown USA 12345 Page 1 of 2

[filename and path]
Figure 13. Sample Preanalytic Procedure

Volume 22 HS4-A
Identifying the Patient for Specimen Collection Effective Date: mm/dd/yy

Document # / version #
Identifying the Patient for Specimen Collection (continued)
Procedure B: Follow the steps in the table below to properly identify outpatients.
Outpatients
Step Action
1 Ask the patient to
• spell his or her first and last names, and
• give his/her date of birth.
2 Verify the spelling and date of birth against the
• label, and
• requisition.
3 Proceed with specimen collection only when patient
identification is verified. If identification cannot be verified,
proceed to step 4.
4 Follow the directions in the table when steps 1 and 2 cannot be
followed.
If: Then:
the patient is unable to • get the information from a family
provide information member or caregiver, if present, or
for whatever reason, • if not present, notify the person in
charge.
the identifiers do not • contact the registration desk, and
match, • resolve the discrepancies before
proceeding.
the ID band is present • do not proceed, and
but not attached to the • notify the patient’s nurse.
patient,
5 Proceed with specimen collection only when patient
identification is verified.
Related Procedure ID. XXX: Emergency Identification Procedure

Procedures
Appendixes Appendix 1: Example of Patient Identification Band
End
Anytown Hospital Laboratory, Anytown USA 12345 Page 2 of 2

[filename and path]
Figure 13. Sample Preanalytic Procedure (continued)

Number 23 NCCLS
6.6.4 Process Control
Once a quality system is put into place, each operation must be monitored to ensure that it is functioning
as designed and that it contributes to achieving the goals and objectives stated in the quality manual.
Tools available for monitoring respiratory and laboratory processes include:
• a quality control program that reflects the internal needs of each respiratory service and meets
minimum regulatory requirements (see Section 6.6.4.1);
• proficiency testing (applicable in arterial blood gas labs) programs that offer an external peer-based
assessment of process output (see Section 6.6.4.2);
• programs that offer an external peer-based assessment of process output, i.e., may need to be
developed by best practice review, user groups, or benchmarking;
• occurrence logs which itemize and characterize problems with process or product output (see Section
6.8.);
• statistical techniques which help laboratory personnel to understand process performance and analyze
trends (see Section 6.6.4.3); and
• quality indicators that include thresholds which cause respiratory and laboratory staff to review the
process (see Section 6.9).
6.6.4.1 Quality Control (QC)
Quality control is a vital part of assuring the quality of the laboratory’s test methods. In the respiratory
and/or laboratory’s written policy for QSE: Process Control, it should state that the QC program considers
government regulations, accreditation requirements, manufacturer’s recommendations, and laboratory
needs.21
6.6.4.2 Proficiency Testing for Arterial Blood Gas Laboratories (External Quality Assessment)
In the laboratory’s written policy for QSE: Process Control, it should state that the laboratory participates
in a program of external quality assessment such as proficiency testing (PT). There should be a written
description of the PT process that minimally includes:
• enrollment in appropriate programs;

• rotation of testing personnel and equipment;
• the laboratory’s procedure for handling PT specimens;
• tracking of performance;
• evidence of meeting requirements; and
• investigation and corrective action for unacceptable results.
Guidance for investigating unacceptable results can be found in the current edition of NCCLS document
GP22—Continuous Quality Improvement: Essential Management Approaches.

Volume 22 HS4-A
6.6.4.3 Use of Statistical Tools
Statistical tools have been described and used for controlling processes. These include:
• run charts;
• Pareto chart;
• histogram;
• control chart; and
• process capability.
These tools extend the use of statistics beyond the traditional Levey-Jennings charts commonly used for
results of QC control tests.44
6.7 QSE: Information Management
The organization’s commitment to quality in the flow of information between service units within the
organization, as well as communication with external entities, should be defined unequivocally. Please
refer to NCCLS document HS1—A Quality System Model for Health Care for more detailed information
on developing this QSE.
6.8 QSE: Occurrence Management
The policy for QSE: Occurrence Management should state that the respiratory service and/or laboratory
will capture information about occurrences that could have or have had adverse implications for patients,
employees, or visitors.

Number 23 NCCLS
6.8.1 Uniform Document for Capturing Information
The respiratory service and/or laboratory should develop an internal system to capture and report any and
all occurrences when a process or procedure did not or might not have the expected outcome (e.g., “near
miss”). Examples include: reporting of occasions when other services did not follow established policy,
therefore affecting the respiratory service and/or laboratory’s ability to meet its customers’ expectations;
all occasions of verbal or written customer complaints; communications failures within the respiratory
service and/or laboratory and to outside customers; and problems with technical operations. An
occurrence report form should minimally include space for tracking number, date/time of occurrence,
description, and resolution. An example of an occurrence report form is provided in Figure 14 below.
Occurrence Report Form

OR#:
Department employees: Complete this section only and return to supervisor.
Initiated by: Date: Time:
Brief description of occurrence: (Do not use names of employees or patients.)
Immediate-action taken (short-term solution):
Time spent on occurrence resolution:

Was Hospital Incident Report Completed? Yes No
DEPARTMENT SERVICE
ABG Laboratory Home care Rehabilitation
ABG/PF Laboratory Hospital computer system Safety
computer system
Administration Other Sleep diagnostics
Adult acute care Outreach program Specimen analysis
Cardiac diagnostics Pediatric acute care Subacute care
Dept. computer system Point-of-care testing Transport
General therapy Pulmonary diagnostics
OCCURRENCE CLASSIFICATION
Accident Mislabel QC documentation
Communication Other Report error
Equipment malfunction Personal deviation from A B C
SOP
External department Planned deviation from
SOP
QUALITY SYSTEM ESSENTIAL

Assessment Information Management Process Control
Documents and Records Occurrence Management Process Improvement
Equipment Organization Purchasing/Inventory
Facilities and Safety Personnel Service and Satisfaction
Continued on next page
Effective Date
Figure 14. Sample Occurrence Report Form

Volume 22 HS4-A
OPERATING SYSTEM-PULMONARY LABORATORY

PRETEST Patient assessment Request
Equipment preparation Patient preparation
TESTING Patient training Testing
Patient assessment for further Results review and
testing selection
POST-TESTING Reporting Interpretation
SOP(s) INVOLVED
INVESTIGATION OF OCCURRENCE:
Supervisor: Date:
Quality Coordinator: Date:
INSTRUCTIONS:
Staff Complete all sections in the box on the front and return to supervisor.
Section Complete the remainder of the form and submit to quality coordinator for
supervisor entry into the occurrence log database.
• Check box for department function.
• Classify occurrence:
- planned deviation from SOP: approved by supervisor or medical
director.
- personal deviation from SOP: unapproved deviation from SOP.
- complaint: dissatisfaction with any elements of the service.
- QC documentation: failure to appropriately document QC or any
comments associated with QC.
- accident: nonpreventable occurrences.
- mislabel: any type of specimen labeling exclusion or error.
- communication: lack of optimal exchange of information.
- results report error (A/B/C): A= error available to all users. B= error
available only in the laboratory. C= cosmetic correction, does not change
result.
- external department: source of occurrence is external to the service or
department.
- equipment malfunction: malfunction not related to deviation from SOP.
- other: Describe when none of the above apply.
• Choose a quality system essential, where applicable.
• Choose the operating system involved in the occurrence.
• Identify any SOP(s) involved.
• Determine what factors caused the variance.
Quality • Review all occurrence report forms.
Coordinator • Enter all information into the occurrence log database.
• Retrieve information for trending information, periodic reports, and
identification of quality improvement projects.
End
Effective Date
Figure 14. Sample Occurrence Report Form (continued)

Number 23 NCCLS
6.8.2 Immediate Action and Investigation
The employee who discovers the problem should take the necessary steps to resolve the immediate issue
and document what was done on the occurrence report form. The form is given to the designated person
who logs the occurrence; the investigation then begins. A sample occurrence log is illustrated in Figure 15
below. Electronic spreadsheets and databases can also be used, as well as hard copy to record and analyze
data.
Occurrence Reported Occurrence Operating Occurrence Preventive Preventive Finalized

Number By Type System Source Action Action and
Involved Completed Verified Closed
Date (Yes/No) Out (date)

Effective Date
Figure 15. Sample Occurrence Log
6.8.3 Investigation and Corrective Action
Awareness of a problem carries the responsibility that something will be done to remove its cause and
prevent recurrence. A plan of corrective action should be devised, implemented, and documented,
including the method for assessing its effectiveness. See Section 6.10 for a discussion on the continuous
improvement process.

Volume 22 HS4-A
6.9 QSE: Assessment
The policy for “QSE: Internal Assessment” should state that the respiratory and/or pulmonary laboratory
will develop and monitor indicators for paths of workflow and periodically conduct internal assessments
of its quality system and operations. Quality indicators are those observations, statistics, or data that
typify the performance of a process. There is no one set of indicators that has been required,
recommended, or suggested for pulmonary or other respiratory service functions. On the contrary, each
respiratory service has been encouraged to identify its own high-risk, high-cost, and problematic issues.
Blood gas laboratories may also voluntarily participate in a subscription service of quality assurance
studies that benchmarks their performance to that of their peers.
6.9.1 Mapping Current Quality Indicators to the Pulmonary Laboratory’s Path of Workflow
Pulmonary laboratories are encouraged to map their current clinical quality indicators to the quality
system framework. This can be accomplished by listing the name of the indicator under the respective
column of the path of workflow that best represents what the indicator measures. An example is provided
in Appendix A. The results of such mapping will show the laboratory which areas in the path of workflow
they are not currently monitoring. To assure that all the laboratory’s processes function as needed and
expected, one or more quality indicators should be monitored in each operating system or each section of
the path of workflow.
Published indicators45,46 that are applicable to arterial blood gas laboratories have been grouped by
operating system and QSE. The list is provided in Appendix B.
6.9.2 Mapping Current Quality Indicators to the Respiratory Services’ Path of Workflow
Each respiratory service is encouraged to map its current clinical quality indicators to the quality system
framework. This can be accomplished by listing the name of the indicator under the respective column of
the path of workflow that best represents what the indicator measures. An example is provided in
Appendix C. The results of such mapping will show the service which areas in the path of workflow it is
not currently monitoring. To assure that all of the service’s processes function as needed and expected,
one or more quality indicators should be monitored in each operating system or each section of the path of
workflow.46
6.9.2.1 Internal Auditing
A quality system audit reviews the facility’s quality system. It assesses whether or not the respiratory
service and/or laboratory has a quality system in place, and evaluates the service's compliance with its
internal policy statements as well as any applicable regulations and requirements.
6.9.2.2 The Quality Audit47,48
The auditor assesses the intent, implementation, and effectiveness of the facility’s quality system by
reviewing the documented quality system and conducting personal observations. The purpose is to verify
that a quality system exists, is being followed, and is effective in maximizing the quality of testing and
services to the customer.
To evaluate intent, the auditor examines whether or not the facility has stated in writing its intent to fulfill
the quality system requirements. This intent is manifested in the policies for the quality system essentials
as outlined in the quality manual.

Number 23 NCCLS
To evaluate implementation, the auditor examines whether or not the facility has defined its processes and
procedures, and communicated them adequately to its employees. The auditor also determines whether
employees are following the quality system.
To evaluate effectiveness, the auditor examines the facility’s records to see whether or not the testing and
services rendered from the stated processes and procedures meet the stated intent, any applicable
regulations or requirements, and the customers’ needs.
6.9.2.3 Auditors
Individuals performing quality system audits should receive special training in the audit function.
Whenever possible, auditors should be from clinical departments that are different from those being
audited.
6.9.2.4 The Audit Report
At the conclusion of the audit, the auditor issues a report to management that describes any discrepancies
between the laboratory’s documented quality system and what the auditor found in the records review,
interviews, and observations. The report is written in a way to help management understand the impact of
the discrepancies on the quality of its testing and services to its customers.
6.9.3 Periodic Reporting
Respiratory services and pulmonary laboratories should periodically report their findings from quality
indicators and audits to the organizational body responsible for monitoring/maintaining the service's
quality function and management.
An example of a systematic surveillance report can be found in NCCLS document GP22—Continuous

Quality Improvement: Essential Management Approaches.
6.10 QSE: Process Improvement
The policy for "QSE: Process Improvement" should state that respiratory services and the pulmonary
laboratory uses a problem resolution process and quality improvement tools to resolve problems and
improve the quality of its test results and services to its customers. (Please refer to the most current
version of HS1—A Quality System Model for Health Care for more detailed information on the
development of this QSE.) Respiratory services and the pulmonary laboratory should apply the problem
resolution process to all quality improvement efforts undertaken.
6.10.1 Periodic Reporting
The respiratory service should, at predefined intervals, report its quality improvement activities, progress,
and findings to the organization’s quality management committee.
6.11 QSE: Service and Satisfaction
One aspect by which a respiratory service’s effectiveness can be measured is customer service and
satisfaction. Respiratory service providers should identify their customers, determine customers’
respective needs, structure their processes and procedures to meet these needs to the customers’
satisfaction, and actively seek customer feedback to determine if the needs are being met.
Respiratory services customers include both internal and external groups. External to the site of the
delivery of respiratory therapeutics are customers such as patients, physicians, outreach clients,

Volume 22 HS4-A
accrediting/regulatory agencies, and other healthcare providers. Internal customers include physicians,
respiratory therapists, nurses, and other caregivers in the organization, who impact or are impacted by the
delivery of respiratory therapeutics. Respiratory service providers should develop mechanisms to measure
the satisfaction of the different customer groups, survey the customers, and analyze the results of the
survey efforts. Where feedback indicates the need for improvement, the service should undertake
corrective actions.
Consultation with customers is also the responsibility of respiratory service providers. Pulmonologists are
commonly queried to provide advice on therapeutic interventions, whereas respiratory service providers
are often contacted by patients and caregivers about the status and outcome of therapeutic interventions.
Each service should have a process for providing and monitoring consultation services and procedures for
contacting those who provide consultations.
Guidance for the development and measurement of customer satisfaction tools may be provided by
marketing, public relations, or quality management departments.49
6.12 QSE: Facilities and Safety
Each healthcare service should provide and maintain a work environment that provides safety for all, in
compliance with standards and requirements. Please refer to the most current version of NCCLS
document HS1—A Quality System Model for Health Care for more detailed information on the
development of this QSE.

Number 23 NCCLS
References
1
Deming WE. Out of the Crisis. Cambridge, MA: MIT Press; 1986.
2
Juran JM. Juran on Quality by Design: Then New Steps for Planning Quality into Goods and
Services. New York, NY: Free Press; 1992.
3
Gee G, Richardson W, Wortman B. The Quality Manager Primer. 2nd ed. West Terre Haute, IN:
Quality Council of Indiana; 1996.
4
Berte LM. Tools for quality improvement in the transfusion service. Am J Clin Pathol.1997:107(4,
Suppl 1)S36-42.
5
Maslow AH. A theory of human motivation. Psychological Review. 1943:50;370-396.
6
FDA. Guideline on Quality Assurance in Blood Establishments. Washington DC: US Government
Printing Office; 1995.
7
American Association of Blood Banks. The Quality Program.Bethesda, MD: AABB;1994.
8
American Association of Blood Banks. Quality Program Implementation. Association Bulletin 97-4.
Bethesda, MD: AABB; 1997.
9
American Association of Blood Banks. Standards for Blood Banks and Transfusion Services. 18th ed.
Bethesda, MD: AABB; 1997.
10
International Organization for Standardization. ISO Standards Compendium: ISO 9000 Quality
Management. 6th ed. Geneva:1996.
11
International Organization for Standardization. ISO 9001. Quality systems—Model for quality
assurance design, development, production, installation, and servicing. Geneva:1994.
12
International Organization for Standardization. Quality Management in the Clinical Laboratory.
ISO/DIS 15189. Geneva: 1998.
13
International Organization for Standardization. General Requirements for the Competence of Testing
and Calibration Laboratories. ISO/IEC DIS 17025. Geneva: 1998.
14
International Organization for Standardization. Quality management systems—Guidelines for
performance improvements. 2nd ed. ISO 9004. Geneva: 2000.
15
Russell JP, ed. The Quality Audit Handbook. Milwaukee, WI: ASQ Press; 1997.
16
International Organization for Standardization. International Vocabulary of Basic and General Terms
in Metrology (VIM). Geneva:1993.
17
International Organization for Standardization. Quality Management and Quality Assurance
Vocabulary. ISO 8402. Geneva: 1994.
18
Joint Commission on Accreditation of Healthcare Organizations, In: Cousinis DD, ed. Medication
Use: A System's Approach in Reducing Errors. Oak Brook Terrace, IL: JCAHO; 1998.

Volume 22 HS4-A
19
American Association of Blood Banks. Accreditation Information Manual. 2nd ed. Bethesda, MD:
AABB; 1998.
20
American Thoracic Society. Lung function testing: selection of reference values and interpretative
strategies. Am Rev Respir Dis. 1991;144:1202-1218.
21
American Thoracic Society. Pulmonary Function Laboratory Management and Procedure Manual.
New York, NY: ATS; 1998.
22
American Association for Respiratory Care. Clinical Practice Guidelines: Spirometry. Dallas, TX:
AARC;1996.
23
American Thoracic Society. Single-breath carbon monoxide diffusing capacity (transfer factor):
recommendations for a standard technique. Am Rev Respir Dis. 1987;136:1299-1307.
24
American Thoracic Society. Standardization of spirometry. 1994 Update. Am J Respir Crit Care Med.
1995;152:1107-1136.
25
American Thoracic Society. Standardization of spirometry. 1987 Update. Am Rev Respir Dis.
1987;136:1285-1298.
26
American Association for Respiratory Care. Clinical practice guideline: body plethysmography.
Respir Care. 1994;39(12):1184-1190.
27
American Association for Respiratory Care. Clinical practice guideline: bronchial provocation. Respir
Care. 1992;37:902-906.
28
American Association for Respiratory Care. Clinical practice guideline: exercise testing for
evaluation of hypoxemia and/or desaturation. Respir Care. 1992;37:907-912.
29
American Thoracic Society. Pulmonary function laboratory personnel qualification. Am Rev Respir
Dis. 1986;134:623-624.
30
American Association for Respiratory Care. Clinical practice guideline: single-breath carbon
monoxide diffusing capacity. Respir Care. 1999.
31
American Association for Respiratory Care. Clinical practice guideline: static lung volumes. Respir
Care. 1994;39:830-836.
32
European Respiratory Society. Standardization of the measurement of transfer factor (diffusing
capacity). Eur Respir J. 1993;6(Suppl 16):41-52.
33
Clinical Laboratory Management Association. Competency Assessment—an exploratory study.
CLMR. 1997;11(6):374-381.
34
TechEd. Diagnostic Training and Competency Assessment Manual: Pulmonary and Non-invasive
Cardiology. Mason, MI: TechEd; 1999.
35
American Association of Respiratory Care. Orientation and Competency Assurance Manuel for
Respiratory Care. Dallas, TX: AARC; 1997.

Number 23 NCCLS
36
Clinical Laboratory Management Association. Training, Verification, and Assessment: Keys to
Quality Management. Malvern, PA: CLMA; 1993.
37
American Society of Clinical Pathologists. Comptec-® [Computer Program]. Chicago, IL: ASCP;
1995.
38
NCCLS. Training Verification Tracker. Application GP21 TVT. Wayne, PA: NCCLS; 1997.
39
Blonshine SB, Brown RA. A step-wise approach to equipment acquisition. RT Update. Respir Care.
1996;41:629-636.
40
Wanger J. Equipment validation: developing a strategy in the pulmonary function laboratory.
Advance for Respiratory Care Managers. September 1996;39-43.
41
Kessler S. Measuring and Managing Customer Satisfaction: Going for the Gold. Milwaukee, WI:
Quality Press; 1996.
42
Tech Ed. Spirometry Quality: The Essentials. Mason, MI. TechEd; 2000.
43
U.S. Food and Drug Administration. Guideline on General Principles of Process Validation.
Washington DC: US Government Printing Office; 1987.
44
Brassard M, Ritter D. The Memory JoggerIITM. Methuen, MA: GOAL/QPC; 1994.
45
American Society for Testing and Materials. In: J. Shillenn, ed. Validation Practices for
Biotechnology Products: STP 1260. Conshohocken, PA: ASTM; 1996.
46
American Association of Respiratory Care. Diagnostic Uniform Reporting Manual. Dallas, Texas:
AARC;1999.
47
Arter DA. Quality Audits for Improved Performance. 2nd ed., Milwaukee, WI: ASQC Press; 1994.
48
Russel JP, Regel T. After the Quality Audit: Closing the Loop on the Audit Process. Milwaukee, WI:
ASQC Press; 1996.
49
The Team Memory Jogger. Goal/QPC and Joiner Associates, Inc.; 1995.

Volume 22 HS4-A
Appendix A. Examples of Pulmonary Function (PF) Laboratory Quality Indicators

by Operating System
Determining rate of/source of/and reasons for:
Patient Assessment Testing and Review

• unstated reasons for test orders. • lack of trial acceptability.
• inappropriate reasons for test orders. • lack of reproducibility.
• inadequate number of trials.
Test Request Process
• requests missing required or critical information. Laboratory Interpretation
• missing patient instructions. • disparities in
- PF results obtained by two separate methods.
• incorrect scheduling.
- calculated and measured parameters.
Patient Preparation
Results Reporting
• inaccuracies in entry of patient demographics.
• times alert values were not reported or
• lack of adherence to pretest instructions. documented.
• completeness/correctness of reports.
Equipment Preparation • delayed reports.
• lack of calibration data. • corrected reports due to reporting errors.
• incorrect reference values. • disparities between preliminary and final reports.
Patient Training Post-test Data Management

• ineffective or lack of test performance • retained data unable to be retrieved.
instructions.
Clinical Interpretation and Application
Laboratory Information System • inappropriate action taken after report of results.
• security violations. • inappropriate test performed per protocols.
• unscheduled downtimes.
• inability to retrieve archived patient results and
information.

Number 23 NCCLS
Appendix B. Published Laboratory Quality Indicators (Applicable to the Arterial

Blood Gas Laboratory) Grouped by Laboratory Operating System and QSE
Patient Assessment • Report adequacy (autopsy, breast carcinoma, lung
• Practice guideline implementation. carcinoma, surgical pathology).
• Duplicate test ordering. • Correct physician sent report.
• Charting of results.
Test Request • Critical diagnosis reporting.
• Ordering accuracy. • Reporting error.
• Accuracy of order transmission.
• Verbal order evaluation. Clinical Interpretation and Application
• Critical test results.
Specimen Collection/Labeling • Nosocomial infection rate.
• Wristband evaluation.
QSE: Personnel
Specimen Transport • Competence evaluation.
• Transit time. • Employee retention.
• Stat transit time.
QSE: Process Control
Specimen Receiving/Processing • Safety.
• Adequacy of fine-needle aspiration. • Comparative cost of in-house vs. reference
• General specimen acceptability. laboratory testing.
• Chemistry specimen acceptability.
• Sputum specimen adequacy. QSE: Occurrence Management
• Incidents.
Testing and Review
• Proficiency testing. QSE: Internal Assessment
• Quality control. • On-site inspections/assessments.
• Testing turnaround time. • Self-inspections/assessments.
• Turnaround time outliers.
QSE: Service and Satisfaction
Laboratory Interpretation • Quality of telephone responsiveness.
• Fine-needle cytohistological correlation. • Reference laboratory service quality.
• Results reporting. • Customer satisfaction.
• Complaint.
References for Appendix B
Schifman RB, Howanitz PJ, Zarbo RJ. Q-Probes: A college of American Pathologists benchmarking program for quality
management in pathology and laboratory medicine. Adv Pathol. 9:83-120;1996.
Bachner P, Howanitz PJ, Lent RW. Quality improvement practices in clinical and anatomic pathology services. Am J Clin Pathol.
102:567-571;1994.

Volume 22 HS4-A
Appendix C. Examples of Respiratory Services Quality Indicators for Operating

Systems
Determining rate of/source of/and reasons for:
Assessment Equipment Preparation

• Inappropriate reason for therapy. • SOP for equipment followed.
• Inappropriate mode of therapy. • Yearly competency for therapist.
• Outcomes appropriate for patient. • Ineffective or lack of patient to follow
instructions.
Information Gathering
• Necessary laboratory data available. Patient Preparation
• All healthcare providers consulted. • SOP for verification of patient.
• Consensus on need for therapy. • Ineffective or lack of patient to comply with
• Patient goals meet AARC CPG indicators for instructions.
therapy.
Outcomes Assessment
Patient Preparation • Ineffective or lack of patient to follow
• Ineffective or lack of understanding of therapy. instructions.
• Inability to follow commands or perform • Assess patient/therapy outcomes to AARC CPGs.
therapy. • Therapy not adjusted to meet needs of patient.
Equipment Preparation Chart

• Lack of adequate equipment. • Policy and Procedure for charges.
• Infection control rates. • Charting is legible.
• Equipment safety verification testing. • Delayed charting.
Request for Therapy Outcomes with Healthcare Team

• Verification of therapist skills. • Compare outcomes of therapy to care path
• Adequate staffing. guidelines.
• Request missing required or critical information. • Delayed conferencing/notification of healthcare
• Verbal orders verified according to medical staff team.
bylaws.
• Orders transcribed correctly into electronic
system.
Determine Therapeutic Goal

• Goals for therapy meet AARC CPGs compared
to care path processes.

Number 23 NCCLS
Summary of Comments and Working Group Responses
NCCLS consensus procedures include an appeals process that is described in detail in Section 9 of
the Administrative Procedures. For further information contact the Executive Offices or visit our
website at www.nccls.org.
HS4-P: A Quality System Model for Respiratory Services; Proposed Guideline
General
1. One concern is the overall time that must be dedicated to the implementation of this type of program.
When each department or service is dedicating the resources required to implement a program of this
nature, these resources must be taken from patient care, so that in the short term, patient care
resources may be reduced.
• The working group agrees that dedication of time is required to implement a quality model.
However, the working group believes that with consistent direction and “buy-in” of the
organization's management, resources will not be taken from patient care, rather
implementation of this model will enhance patient care. As accrediting and regulatory bodies
move toward a quality system philosophy, the model will provide the added benefit of
simplifying the process.

Volume 22 HS4-A
Related NCCLS Publications*

GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline — Fourth
Edition (2002). This document provides guidance on development, review, approval,
management, and use of policy, process, and procedure documents in the laboratory
testing community.
GP6-A Inventory Control Systems for Laboratory Supplies; Approved Guideline (1994).
This document contains recommendations for inventory control systems to ensure the
availability of reagents and supplies in the laboratory.
GP21-A Training Verification for Laboratory Personnel; Approved Guideline (1995). This
document provides background and recommends an infrastructure for developing a
training verification program that meets quality/regulatory objectives.
GP22-A Continuous Quality Improvement: Essential Management Approaches; Proposed

Guideline (1999). This guideline considers continuous quality improvement (CQI) as a
system of managerial programs addressing actualization, quality anticipation, and quality
assessment and improvement.
HS1-A A Quality System Model for Health Care; Approved Guideline (2002). This document
provides a model for healthcare service providers that will assist with the implementation
and maintenance of effective quality systems.
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 System for the Clinical Laboratory (NRSCL).
*
Proposed- and tentative-level documents are being advanced through the NCCLS consensus process; therefore, readers should
refer to the most recent editions.

Number 23 NCCLS
NOTES

NCCLS T 940 West Valley Road T Suite 1400 T Wayne, PA 19087 T USA T PHONE 610.688.0100
FAX 610.688.0700 T E-MAIL: exoffice@nccls.org T WEBSITE: www.nccls.org T ISBN 1-56238-476-7

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HS4-A

Application of a Quality System Model for Respiratory Services;

Reproduced with permission, from NCCLS publication HS4-A—Application of a Quality

Copyright ©2002. The National Committee for Clinical Laboratory Standards.

Area Committee on Healthcare Services

Kathleen J. Sazama, M.D., J.D. University of Texas

Judy Dye, M.A. University of Arizona Medical Center

Bernard M. Branson, M.D. Centers for Disease Control and Prevention

James B. Conway Dana-Farber Cancer Institute

Barbara M. Goldsmith, Ph.D. Alliance Laboratory, Inc.

Jeffrey S. Johnson, M.S. Spectrum Health

Carl R. Mottram, BA, RRT, RPFT, FAARC Mayo Clinic

Robert Wise, M.D. JCAHO

Susan Blonshine, BS, RRT, RPFT, FAARC, AE-C TechEd Consultants

Jonathan S. Krauss, M.D. Medical College of Georgia Hospitals and Clinics

Robert McNamee Dianon Systems, Inc.

George Pounds, C.L.S., M.T.(ASCP) Quest Diagnostics, Incorporated

Jennifer K. McGeary, M.T.(ASCP), M.S.H.A. NCCLS

Patrice E. Polgar NCCLS

Donna M. Wilhelm NCCLS

Susan Blonshine, B.S., RRT, RPFT, FAARC, AE-C – TechEd Consultants

Sustaining Members College of Physicians and Deutsches Institut für Normung

BD EXPERTech Associates, Inc. Radiometer Medical A/S

State of Washington Department of University of Alabama-Birmingham VA Outpatient Clinic (OH)

OFFICERS BOARD OF DIRECTORS

Thomas L. Hearn, Ph.D., Wayne Brinster J. Stephen Kroger, M.D., MACP

Active Membership.............................................................................................................................. vii

4 Introduction to the Path of Workflow ........................................................................................4

Appendix A. Examples of Pulmonary Function (PF) Laboratory Quality Indicators by

Appendix B. Published Laboratory Quality Indicators (Applicable to the Arterial Blood

Summary of Comments and Working Group Responses .....................................................................46

Related NCCLS Publications................................................................................................................47

State Activities Performed

Quality System Comprehensive and coordinated efforts to meet quality

Quality Assurance Planned and systematic activities to provide confidence that an

Quality Control Operational techniques to fulfill requirements for quality and

Quality, quality indicators, quality system

Application of a Quality System Model for Respiratory Services;

An NCCLS global consensus guideline. ©NCCLS. All rights reserved. 1

Audit - A planned, independent, and documented assessment to determine whether agreed-upon

Competence - The ability of an individual to perform a specific job or task.

Document - Any written item of a factual or informative nature.

Error - A deviation from truth, accuracy, or correctness; a mistake.

Incident - An individual occurrence or event.

Occurrence - Something that happens; an event, incident.

2 An NCCLS global consensus guideline. ©NCCLS. All rights reserved.

Procedure - A specified way to perform an activity (ISO 8402, 1.3117).

Proficiency testing/External quality assessment/PT//EQA - A program in which multiple specimens

An NCCLS global consensus guideline. ©NCCLS. All rights reserved. 3

4 Introduction to the Path of Workflow

5.1 Pulmonary Diagnostics

Pretest Testing Session Post-test

Patient Assessment Patient Training Results Report

5.1.1 Pretest Phase

Elements of the pretest phase include:

Test Request Process

• generating the order

• calibration and gathering equipment and supplies

5.1.2 Testing Session