AST3-A

AST3-AVol. 19 No. 4

Replaces AST3-PFebruary 1999 Vol. 16 No. 18

Wellness Testing Using IVD Devices; Approved Guideline

This document provides procedures and recommendations for implementing a quality wellness testingprogram.

ABC

NCCLS...Serving the World's Medical Science Community Through Voluntary Consensus

NCCLS is an international, interdisciplinary, nonprofit, receive a wide and thorough technical review, including anstandards-developing and educational organization that overall review of its scope, approach, and utility, and a line-promotes the development and use of voluntary consensus by-line review of its technical and editorial content.standards and guidelines within the healthcare community.It is recognized wordwide for the application of its unique Tentative A tentative standard or guideline is madeconsensus process in the development of standards and available for review and comment only when aguidelines for patient testing and related healthcare issues. recommended method has a well-defined need for a fieldNCCLS is based on the principle that consensus is an evaluation or when a recommended protocol requires thateffective and cost-effective way to improve patient testing specific data be collected. It should be reviewed to ensureand healthcare services. its utility.

In addition to developing and promoting the use of Approved An approved standard or guideline has achievedvoluntary consensus standards and guidelines, NCCLS consensus within the healthcare community. It should beprovides an open and unbiased forum to address critical reviewed to assess the utility of the final document, toissues affecting the quality of patient testing and health ensure attainment of consensus (i.e., that comments oncare. earlier versions have been satisfactorily addressed), and to

PUBLICATIONS NCCLS standards and guidelines represent a consensus

An NCCLS document is published as a standard, guideline, agreement by materially affected, competent, andor committee report. interested parties obtained by following NCCLSs

Standard A document developed through the consensus standards and guidelines may be more or less stringentprocess that clearly identifies specific, essential than applicable regulations. Consequently, conformance torequirements for materials, methods, or practices for use in this voluntary consensus document does not relieve thean unmodified form. A standard may, in addition, contain user of responsibility for compliance with applicablediscretionary elements, which are clearly identified. regulations.

Guideline A document developed through the consensusprocess describing criteria for a general operating practice, COMMENTSprocedure, or material for voluntary use. A guideline maybe used as written or modified by the user to fit specific The comments of users are essential to the consensusneeds. process. Anyone may submit a comment, and all

Report A document that has not been subjected to con- process, by the NCCLS committee that wrote thesensus review and is released by the Board of Directors. document. All comments, including those that result in a

CONSENSUS PROCESS are responded to by the committee in an appendix to the

The NCCLS voluntary consensus process is a protocol in any form and at any time on any NCCLS document.establishing formal criteria for: Address comments to the NCCLS Executive Offices, 940

! The authorization of a project

! The development and open review of documents VOLUNTEER PARTICIPATION

! The revision of documents in response to comments by Healthcare professionals in all specialities are urged tousers volunteer for participation in NCCLS projects. Please

! The acceptance of a document as a consensus information on committee participation.standard or guideline.

Most NCCLS documents are subject to two levels ofconsensus"proposed" and "approved." Depending on theneed for field evaluation or data collection, documents may also be made available for review at an intermediate (i.e.,"tentative") consensus level.

Proposed An NCCLS consensus document undergoes thefirst stage of review by the healthcare community as aproposed standard or guideline. The document should

identify the need for additional consensus documents.

opinion on good practices and reflect the substantial

established consensus procedures. Provisions in NCCLS

comments are addressed, according to the consensus

change to the document when published at the nextconsensus level and those that do not result in a change,

document. Readers are strongly encouraged to comment

West Valley Road, Suite 1400, Wayne, PA 19087, USA.

contact the NCCLS Executive Offices for additional

Vol. 19 No. 4 AST3-A

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THE NCCLS consensus process, which is the mechanism for moving a document through two ormore levels of review by the healthcare community, is an ongoing process. Users should expectrevised editions of any given document. Because rapid changes in technology may affect theprocedures, methods, and protocols in a standard or guideline, users should replace outdatededitions with the current editions of NCCLS documents. Current editions are listed in the NCCLSCatalog, which is distributed to member organizations, and to nonmembers on request. If yourorganization is not a member and would like to become one, and to request a copy of the NCCLSCatalog, contact the NCCLS Executive Offices. Telephone: 610.688.0100; Fax: 610.688.0700;E-Mail: [email protected].


Abstract

Wellness Testing Using IVD Devices; Approved Guideline (NCCLS document AST3-A) provides usefulinformation to directors of wellness testing services to assist them in implementing a quality program.The guideline addresses preanalytical and postanalytical considerations and safety and training issuesrelated to wellness testing using IVD devices. While the guideline does not specify which tests shouldbe included in a wellness program,it includes recommendations for providing accurate and adequateinformation as well as referring participants to clinicians for subsequent follow-up, depending on theresults obtained from common wellness tests.

(NCCLS. Wellness Testing Using IVD Devices; Approved Guideline. NCCLS document AST3-A [ISBN1-56238-370-1]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA1999.)

February 1999 NCCLS

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AST3-AISBN 1-56238-370-1

February 1999 ISSN 0273-3099


Volume 19 Number 4

Nina Peled, Ph.D., ChairholderK. Owen Ash, Ph.D.Alfred H. Free, Ph.D.Kenneth D. McClatchey, M.D., D.D.S.Diana Trundle Ott, Ph.D.David L. Witte, M.D., Ph.D.

ABC

February 1999 NCCLS

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This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system,or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, orotherwise) without written permission from NCCLS, except as stated below.

NCCLS hereby grants permission to reproduce limited portions of this publication for use in laboratoryprocedure manuals at a single site, for interlibrary loan, or for use in educational programs provided thatmultiple 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 AST3-AWellness Testing Using IVDDevices; Approved Guideline. Copies of the current edition may be obtained from NCCLS, 940West 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 theexemptions 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 1999. The National Committee for Clinical Laboratory Standards.

Suggested Citation

NCCLS. Wellness Testing Using IVD Devices; Approved Guideline. NCCLS document AST3-A (ISBN1-56238-370-1). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA,1999.

Proposed GuidelineDecember 1996

Approved GuidelineFebruary 1999

ISBN 1-56238-370-1ISSN 0273-3099


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Committee Membership

Area Committee on Alternative Site Testing

Robert L. Habig, Ph.D. Becton Dickinson and CompanyChairholder Franklin Lakes, New Jersey

Barbara Goldsmith, Ph.D. St. Christophers Hospital for ChildrenVice Chairholder Philadelphia, Pennsylvania

Subcommittee on Wellness Testing

Nina Peled, Ph.D. Cygnus, Inc.Chairholder Redwood City, California

K. Owen Ash, Ph.D. ARUP Laboratories, University of UtahSalt Lake City, Utah

Alfred H. Free, Ph.D. Bayer CorporationElkhart, Indiana

Kenneth D. McClatchey, M.D., D.D.S. Loyola University Medical CenterMaywood, Illinois

Diana Trundle Ott, Ph.D. Clearwater Clin. Lab. & Ott Lab. ConsultantsRuskin, Florida

David L. Witte, M.D., Ph.D. Laboratory Control, Inc.Ottumwa, Iowa

Advisors

John W. Kennedy Medstat ConsultantsPalo Alto, California

S.K. Vadlamudi, D.V.M., Ph.D. FDA Center for Devices/Radiological HealthRockville, Maryland

Carl A. Burtis, Ph.D. Oak Ridge National LaboratoryBoard Liaison Oak Ridge, Tennessee

Beth Ann Wise, M.T.(ASCP), M.S.Ed. NCCLSStaff Liaison Wayne, Pennsylvania

Patrice E. Polgar NCCLSEditor Wayne, Pennsylvania

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ACTIVE MEMBERSHIP (as of 1 JANUARY 1999)

Sustaining Members

Abbott LaboratoriesAmerican Association for Clinical ChemistryBayer CorporationBeckman Coulter, Inc.Becton Dickinson and CompanybioMrieux Vitek, Inc.College of American PathologistsDade Behring Inc.Ortho-Clinical Diagnostics, Inc.Pfizer IncRoche Diagnostics, Inc.

Professional Members

American Academy of Family PhysiciansAmerican Association of BioanalystsAmerican Association of Blood BanksAmerican Association for Clinical ChemistryAmerican Association for Respiratory CareAmerican Chemical SocietyAmerican Medical TechnologistsAmerican Public Health AssociationAmerican Society for Clinical Laboratory ScienceAmerican Society of HematologyAmerican Society for MicrobiologyAmerican Society of Parasitologists, Inc.American Type Culture Collection, Inc.Asociacion Espanola Primera de SocorrosAsociacion Mexicana de Bioquimica Clinica A.C.Assn. of Public Health LaboratoriesAssoc. Micro. Clinici Italiani- A.M.C.L.I.Australasian Association of Clinical BiochemistsBritish Society for Antimicrobial ChemotherapyCanadian Society for Medical Laboratory ScienceSocit Canadienne de Science de Laboratoire MdicalCanadian Society of Clinical Chemists

Clinical Laboratory Management Department of Veterans Affairs Association Deutsches Institut fr NormungCollege of American (DIN) Pathologists FDA Center for Devices andCollege of Medical Laboratory Radiological Health Technologists of Ontario FDA Division of Anti-InfectiveCollege of Physicians and Drug Products Surgeons of Saskatchewan Federacion Bioquimica de la Commission on Office Provincia (Argentina) Laboratory Accreditation Health Care FinancingInstitut fr Stand. und Dok. im Administration Med. Lab. (INSTAND) Instituto Scientifico HS. International Council for Raffaele (Italy) Standardization in Iowa State Hygienic Laboratory Haematology Manitoba HealthInternational Federation of Massachusetts Department of Clinical Chemistry Public Health LaboratoriesInternational Society for Michigan Department of Public Analytical Cytology HealthItalian Society of Clinical National Association of Testing Biochemistry Authorities - AustraliaJapan Society of Clinical National Institute of Standards Chemistry and TechnologyJapanese Committee for Clinical National Institutes of Health Laboratory Standards Ohio Department of HealthJoint Commission on Oklahoma State Department of Accreditation of Healthcare Health Organizations Ontario Ministry of Health National Academy of Clinical Saskatchewan Health- Biochemistry Provincial Laboratory National Society for South African Institute for Histotechnology, Inc. Medical ResearchOntario Medical Association Swedish Institute for Infectious Laboratory Proficiency Testing Disease Control ProgramOrdre professionnel des technologistes mdicaux du QubecRCPA Quality Assurance Programs PTY LimitedSociedade Brasileira de Analises Clinicas Sociedade Brasileira de Patologia ClinicaSociedad Espanola de Quimica ClinicaVKCN (The Netherlands)

Government Members

Armed Forces Institute of NY Pathology Bayer Corporation - WestAssociation of Public Health Haven, CT Laboratory Directors Bayer-Sankyo Co., Ltd.BC Centre for Disease Control Beckman Coulter, Inc.Centers for Disease Control and Beckman Coulter, Inc. - Palo Prevention Alto, CAChinese Committee for Clinical Beckman Instruments (Japan) Laboratory Standards Ltd.Commonwealth of Pennsylvania Becton Dickinson and Company Bureau of Laboratories

Industry Members

AB BiodiskAbbott LaboratoriesAccuMed International, Inc.Accumetrics, Inc.Amersham Pharmacia BiotechAmmirati Regulatory ConsultingAssssorAvecor Cardiovascular, Inc.Avocet Medical, Inc.Bayer Corporation - Elkhart, INBayer Corporation - Middletown, VABayer Corporation - Tarrytown,


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Becton Dickinson Consumer Labtest Sistemas Diagnosticos SmithKline Beecham, S.A. Products Ltda. Streck Laboratories, Inc.Becton Dickinson LifeScan, Inc. (a Johnson & Sysmex Corporation (Japan) Immunocytometry Systems Johnson Company) Sysmex Corporation Becton Dickinson Italia S.P.A. LifeSign, LLC (Long Grove, IL)Becton Dickinson Microbiology Lilly Research Laboratories Vetoquinol S.A. Systems Medical Device Consultants, Vysis, Inc.Becton Dickinson VACUTAINER Inc. Wallac Oy Systems Medical Laboratory Automation Warner-Lambert CompanybioMrieux Vitek, Inc. Inc. Wyeth-AyerstBiometrology Consultants MediSense, Inc. Xyletech Systems, Inc.Bio-Rad Laboratories, Inc. Merck & Company, Inc. YD ConsultantBiotest AG Neometrics Inc. ZenecaBristol-Myers Squibb Company Nichols Institute Diagnostics (Div.Canadian Reference Laboratory of Quest Diagnostics, Inc.) Ltd. Nissui Pharmaceutical Co., Ltd.CASCONERL Diagnostics Nippon Becton Dickinson Co., Checkpoint Development Inc. Ltd.Chiron Diagnostics Corporation - Norfolk Associates, Inc. International Operations North American Biologicals, Inc.Chiron Diagnostics Corporation - OBC Associates Reagent Systems Olympus CorporationClinical Lab Engineering Optical Sensors, Inc.COBE Laboratories, Inc. Organon Teknika CorporationCombact Diagnostic Systems Ortho-Clinical Diagnostics, Inc. Ltd. (England)Control Lab (Brazil) Ortho-Clinical Diagnostics, Inc. Cosmetic Ingredient Review (Raritan, NJ)Cubist Pharmaceuticals Ortho-Clinical Diagnostics, Inc. Cytometrics, Inc. (Rochester, NY) Dade Behring Inc. - Deerfield, IL Oxoid Inc.Dade Behring Inc. - Glasgow, Oxoid LTD (U.K.) DE Pfizer IncDade Behring Inc. - Marburg, Pharmacia & Upjohn Germany Procter & GambleDade Behring Inc. - Miami, FL Pharmaceuticals, Inc.Dade Behring Inc. - The Product Development Group Sacramento, CA Radiometer America, Inc.Dade Behring Inc. - San Jose, Radiometer Medical A/S CA David G. Rhoads Associates, DAKO A/S Inc.Diagnostic Products Corporation Rhne-Poulenc RorerDiaSorin Roche Diagnostics GmbHEiken Chemical Company, Ltd. Roche Diagnostics, Inc.Enterprise Analysis Corporation Roche Diagnostic SystemsFort Dodge Animal Health (Div. Hoffmann-La Roche Fujisawa Pharmaceutical Co. Inc.) Ltd. Roche Laboratories (Div.Gen-Probe Hoffmann-La Roche Inc.)Glaxo-Wellcome, Inc. The R.W. JohnsonGreiner Meditech, Inc. Pharmaceutical ResearchHealth Systems Concepts, Inc. InstituteHelena Laboratories Sarstedt, Inc.Hoechst Marion Roussel, Inc. Schering CorporationHybritech, Incorporated Schleicher & Schuell, Inc.Hycor Biomedical Inc. Second OpinionI-STAT Corporation SenDx Medical, Inc.Instrumentation Laboratory Showa Yakuhin Kako Company,Integ, Inc. Ltd.International Technidyne SmithKline Beecham Corporation CorporationKendall Sherwood-Davis & Geck SmithKline Beecham (NZ) Ltd.

Trade Associations

Association of Medical Diagnostic ManufacturersHealth Industry Manufacturers AssociationJapan Association Clinical Reagents Ind. (Tokyo, Japan)Medical Industry Association of Australia

Associate Active Members

20th Medical Group (Shaw AFB, SC)67th CSH Wuerzburg, GE (NY)121st General Hosptial (CA)Acadiana Medical Laboratories, LTD (LA)Advocate Laboratories (IL)The Aga Khan University Medical Center (Pakistan)Alabama Reference LaboratoryAllegheny General Hospital (PA)Allegheny University of the Health Sciences (PA)Allina Laboratories (MN)Alton Ochsner Medical Foundation (LA)Anzac House (Australia)Associated Regional & University Pathologists (UT)Baptist St. Anthonys Health Network (TX)Baystate Medical Center (MA)Brazileiro De Promocao (Brazil)Bristol Regional Medical Center (TN)Brookdale Hospital Medical Center (NY)Brooke Army Medical Center (TX)Brooks Air Force Base (TX)Broward General Medical Center (FL)Calgary Laboratory Services (Calgary, AB, Canada)

February 1999 NCCLS

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Cardinal Glennon Childrens Hunter Area Pathology Service Nebraska Health System Hospital (MO) (Australia) New Britain General Hospital Central Kansas Medical Center International Health (CT)Champlain Valley Physicians Management Associates, New England Medical Center Hospital (NY) Inc. (IL) Hospital (MA)Childrens Hospital (LA) Intermountain Health Care The New York Blood Center Children's Hospital Medical Laboratory Services (UT) New York State Department of Center (Akron, OH) Jacobi Medical Center (NY) HealthClendo Lab (Puerto Rico) John Randolph Hospital (VA) New York University Medical Colorado Mental Health Institute Johns Hopkins Medical Center at Pueblo Institutions (MD) NorDx (ME)Columbia Tulsa Regional Kaiser Permanente (CA) North Carolina Laboratory of Medical Center (OK) Kenora-Rainy River Regional Public HealthCommonwealth of Kentucky Laboratory Program (Dryden, North Coast Clinical Community Medical Center (NJ) Ontario, Canada) Laboratory, Inc. (OH)CompuNet Clinical Laboratories Klinicni Center (Slovenia) North Shore University (OH) La Rabida Childrens Hospital Hospital (NY)Consolidated Laboratory (IL) Northwestern Memorial Services (CA) LabCorp (NC) Hospital (IL)Covance CLS (IN) Laboratoire de Sant Publique Ohio State University HospitalsDanville Regional Medical Center du Quebec (Canada) Olin E. Teague Medical Center (VA) Lancaster General Hospital (PA) (TX)Detroit Health Department (MI) Langley Air Force Base (VA) Our Lady of Lourdes Hospital

Duke University Medical Center Center (CA) Our Lady of the Resurrection (NC) Los Angeles County and USC Medical Center (IL)Duzen Laboratories (Turkey) Medical Center (CA) Permanente Medical Group E.A. Conway Medical Center Louisiana State University (CA) (LA) Medical Center Providence Health System (OR)East Texas Medical Center Lutheran Hospital (WI) Providence Medical Center Elmhurst Memorial Hospital (IL) Main Line Clinical Laboratories, (WA)Emory University Hospital (GA) Inc. (PA) Queen Elizabeth Hospital Fairview-University Medical Massachusetts General Hospital (Prince Edward Island, Center (MN) MDS Metro Laboratory Services Canada)Florida Hospital Alta Monte (Burnaby, BC, Canada) Queensland Health Pathology Florida Hospital East Orlando MDS-Sciex (Concord, ON, Services (Australia)Foothills Hospital (Calgary, AB, Canada) Quest Diagnostics (PA) Canada) Med-Chem Laboratories Ltd. Quest Diagnostics Incorporated Fox Chase Cancer Center (PA) (Scarborough, ON, Canada) (NJ)Fresenius Medical Care/Life Medical Center Hospital (TX) Quintiles Laboratories, Ltd. Chem (NJ) Memorial Medical Center (LA) (GA)Grady Memorial Hospital (GA) Memorial Medical Center (IL) Regions HospitalGuthrie Clinic Laboratories (PA) Mercy Health System (PA) Research Medical Center (MO)Hacettepe Medical Center Mercy Hospital (NC) Riyadh Armed Forces Hospital (Turkey) Methodist Hospital (TX) (Saudi Arabia)Harris Methodist Fort Worth Methodist Hospital Indiana Saint Marys Regional Medical (TX) Methodist Hospitals of Memphis Center (NV)Harris Methodist Northwest (TN) St. Alexius Medical Center (TX) Milton S. Hershey Medical (ND)Hartford Hospital (CT) Center (PA) St. Anthony Hospital (CO)Health Alliance Laboratory (OH) Mississippi Baptist Medical St. Boniface General HospitalHealth Network Lab (PA) Center (Winnipeg, Canada)Health Sciences Centre Monte Tabor-Centro Italo- St. Francis Medical Center (Winnipeg, MB, Canada) Brazileiro De Promocao (Brazil) (CA)Hoag Memorial Hospital Montefiore Medical Center (NY) St. John Hospital and Medical Presbyterian (CA) Montreal Childrens Hospital Center (MI)Holmes Regional Medical Center (Canada) St. John Regional Hospital (St. (FL) Mount Sinai Hospital (NY) John, NB, Canada)Holzer Medical Center (OH) Mount Sinai Hospital (Toronto, St. Joseph Hospital (NE)Hopital de Chicoutimi Ontario, Canada) St. Josephs Hospital - (Chicoutimi, PQ, Canada) National Genetics Institute (CA) Marshfield Clinic (WI)Hopital Saint Pierre (Belgium) Naval Hospital Cherry Point (NC) St. Lukes Hospital (PA)

Loma Linda University Medical (NJ)


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St. Lukes Regional Medical Trumbull Memorial Hospital UZ-KUL Medical Center Center (IA) (OH) (Belgium)St. Lukes-Roosevelt Hospital Tulane Medical Center Hospital VA (Albuquerque) Medical Center (NY) & Clinic (LA) Center (NM)St. Mary Hospital (NJ) Twin Lake Regional Medical VA (Dayton) Medical Center St. Mary Medical Center (CA) Center (OH)St. Mary of the Plains Hospital UCSF Medical Center (CA) VA (Denver) Medical Center (TX) UNC Hospitals (NC) (CO)St. Vincents Hospital Unilab Clinical Laboratories VA (Indianapolis) Medical Center (Australia) (CA) (IN)San Francisco General Hospital United Clinical Laboratories VA (Kansas City) Medical (CA) (IA) Center (MO)Seoul Natl University Hospital University of Alabama - VA Outpatient Clinic (OH)(Korea) Birmingham Hospital VA (Tuskegee) Medical Center Shanghai Center for the University of Alberta Hospitals (AL) Clinical Laboratory (China) (Canada) Viridae Clinical Sciences, Inc. Shands Healthcare (FL) University of Chicago Hospitals (Vancouver, BC, Canada)SmithKline Beecham Clinical (IL) ViroLogic, Inc. (CA) Laboratories (GA) University Hospital (IN) ViroMed Laboratories, Inc. South Bend Medical University Hospital (Gent) (MN) Foundation (IN) (Belgium) Waikato Hospital (New Zealand)South Western Area Pathology University Hospital (London, Walter Reed Army Institute of Service (Austraila) Ontario, Canada) Research (MD)Speciality Laboratories, Inc. University Hospital of Warde Medical Laboratory (MI) (CA) Cleveland (OH) Warren Hospital (NJ)Stanford Health Services (CA) The University Hospitals (OK) Washoe Medical Center (NV) Stormont-Vail Regional Medical Watson Clinic (FL) Center (KS) University of Medicine & William Beaumont Hospital (MI)Sun Health-Boswell Hospital Dentistry, NJ University Williamsburg Community (AZ) Hospital Hospital (VA)Sunrise Hospital and Medical University of Michigan Wilford Hall Medical Center Center (NV) University of the Ryukyus (TX)Sutter Health (CA) (Japan) Wilson Memorial Hospital (NY)Timmins & District Hospital University of Texas Medical Winchester Hospital (MA) (Timmons, ON, Canada) School at Houston Winn Army Community Hospital The Toledo Hospital (OH) University of Virginia Medical (GA)Tri-City Medical Center (CA) Center Yonsei University College of Tripler Army Medical Center University of Washington Medicine (Korea) (HI) UPMC Bedford Memorial (PA) York Hospital (PA)

USAF Medical Center (OH) Zale Lipshy University Hospital (TX)

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OFFICERS BOARD OF DIRECTORS

William F. Koch, Ph.D., Carl A. Burtis, Ph.D. Kenneth D. McClatchey, M.D., President Oak Ridge National Laboratory D.D.S.National Institute of Standards Loyola University Medical and Technology Sharon S. Ehrmeyer, Ph.D. Center

F. Alan Andersen, Ph.D., David E. Nevalainen, Ph.D. President Elect Elizabeth D. Jacobson, Ph.D. International Quality SystemsCosmetic Ingredient Review FDA Center for Devices and

Robert F. Moran, Ph.D., Ortho-Clinical Diagnostics, Inc. FCCM, FAIC Carolyn D. Jones, J.D., M.P.H. Secretary Health Industry Manufacturers Eric J. Sampson, Ph.D.mvi Sciences Association Centers for Disease Control

Donna M. Meyer, Ph.D., Hartmut Jung, Ph.D. Treasurer Roche Diagnostics GmbH Marianne C. Watters,Sisters of Charity Health Care M.T.(ASCP) System Tadashi Kawai, M.D., Ph.D. Parkland Health and Hospital

A. Samuel Koenig, III, M.D., Center Past President Ann M. Willey, Ph.D.Family Medical Care New York State Department of

John V. Bergen, Ph.D., Executive Director

University of Wisconsin

Radiological Health Donald M. Powers, Ph.D.

International Clinical Pathology System

and Prevention

Health


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Contents

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

Committee Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Active Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4 Criteria for Choosing Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

5 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

5.1 Components of a Safe Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . 25.2 Safety Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25.3 Creation of an Organized Testing Environment that Facilitates Success . . . 4

6 Operator Training and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

6.1 General Training Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . 46.2 Responsibilities of the Director . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56.3 Selection, Training, and Responsibilities of the Test Operator . . . . . . . . . 56.4 Training Staff Who Provide Educational Information . . . . . . . . . . . . . . . . 6

7 Quality Assurance (QA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

8 Preanalytical Testing Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

9 Postanalytical Considerations and Providing Participant Information . . . . . . . . . . . 8

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Summary of Comments and Subcommittee Responses . . . . . . . . . . . . . . . . . . . . . . . 10

Related NCCLS Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

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Foreword

For many years, NCCLS has been the leading standards organization for medical testing. ThroughNCCLS, individual laboratories and healthcare institutions, laboratory and clinical professional societies,manufacturers and suppliers of products for medical testing, and regulatory and scientific agencies offederal and local governments cooperate to develop, evaluate, and implement voluntary standards andguidelines that support the delivery of quality patient care. The NCCLS consensus process hasgenerated a vital professional dialogue within the clinical laboratory testing community, as well as morerecently, with those professionals involved in providing medical testing services outside the traditionalclinical laboratory.

Advances in technology and implementation of the use of portable instruments have made laboratorytesting more available to the general public through wellness testing programs. This documentaddresses wellness testing programs which provide simple screening tests using in vitro diagnostic (IVD)devices intended to aid in the diagnosis of asymptomatic/preclinical disease or to confirm a state ofhealth. (It is important to note that, in the United States, testing provided by wellness programs isconsidered laboratory testing, and federal and local regulatory requirements for such testing apply.)

The performance of wellness testing at sites other than the conventional clinical laboratory is on theincrease and gaining popularity. In addition to the obvious concerns of accuracy of test results andsafety at the testing site, wellness testing programs present major issues. These issues deal with publiceducation, awareness of test benefits, understanding the significance of a result, and most importantly,follow-up for those at risk.

This guideline provides useful information to directors and operators of wellness testing services toassist them in implementing a quality program. It addresses preanalytical and postanalyticalconsiderations and safety and training issues related to wellness testing using IVD devices.Recommendations for providing participants in wellness testing with accurate and adequate information,along with recommendations for referring participants to clinicians for subsequent follow-up are alsoprovided.

Wellness screening is a useful and important healthcare tool. When applied properly, this tool canprovide better quality of life and can cut healthcare costs. This guideline is intended to improve serviceto the public by providing recommendations on establishing protocols and assigning responsibilities topeople offering wellness testing services. It is written to help all those involved in providing theseservices. Guidelines for the conduct of wellness testing can have a positive effect on the quality ofservice provided to recipients.

Key Words

Alternative site, in vitro diagnostic devices (IVD), safety, universal precautions, wellness testing.

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1


1 Introduction

Wellness testing at sites other than theconventional clinical laboratory is increasing andis being conducted in a variety of publiclocations, such as shopping malls, health clubs,pharmacies, the workplace, and others.

Participant testing in wellness programs isdifferent from most medical laboratory testing.Usually the wellness test request is participant-initiated and, often, the participant is notassociated with a healthcare practitioner who isobligated to review results and take appropriateaction. The responsibility for understanding andimplementing safe and effective performance ofwellness testing rests with the provider.Therefore, for the testing program to beeffective, it should provide the medicalreasoning necessary to choose appropriatetests, inform the participant about theinterpretation of those tests, and recommend Alternative site, n - Any location, other than afurther action. hospital or commercial laboratory, used in the

To assist providers of wellness testing, this the purpose of obtaining results used in theguideline includes recommendations for training diagnosis of disease, risk of disease, or otherand educating operators of in vitro diagnostic health conditions. (IVD) devices, including how to adhere touniversal precautions when handling human Hazardous material, n - Any substance thatbody specimens and disposing of biohazardous poses an immediate or potential threat towaste. While this guideline does not specify human health or to the environment, and whichwhich tests to include in a wellness program, it requires special handling, processing, ordoes include recommendations for referring disposal because it is toxic, infectious,participants to clinicians for subsequent follow- carcinogenic, explosive, or reactive.up.

2 Scope

Healthcare providers, industrial corporations,municipal governments, schools, pharmacies,shopping malls, and health departments mayprovide wellness testing facilities for the public.Usually, requests for tests in wellness testingprograms are self-initiated and participantsexpect to receive informative, interpretativeinformation. This guideline providesrecommendations to directors of wellnesstesting programs to assist them in providing aquality wellness testing program andrecommendations on training wellness testingoperators in giving participants accurate andadequate information. This information shouldbe developed according to good risk

communication principles (see Appendix A ofNCCLS GP14-A).

Wellness testing programs provide informationon risk factors and health status. Distribution ofwellness literature (not necessarily related totesting) is an integral role of wellness centers.Operators should be prepared to provide theparticipant pertinent information on the test.This guideline, focuses on ways to create publicawareness of relevant wellness tests, theirsignificance and follow-up, as well as effectivemeans for referring those found to be at risk tohealthcare facilities.

Although AST3-A focuses on IVD devices, itdoes not cover technical issues that pertain totest methodology or performance.

3 Definitionsa

collection and testing of human specimens for

In vitro diagnostic (IVD) devices, n - Thosereagents, instruments, and systems intended foruse in the diagnosis of disease or other healthconditions and to assist in curing, detecting,mitigating, treating, or preventing disease.NOTE: These devices are intended for use in thecollection, preparation, testing, and examinationof specimens taken from the human body.

Operator, n - A person who collects thespecimen and/or performs the test.

Some of these NCCLS definitions are found in NCCLSadocument NRSCL8Terminology and Definitions For Use inNCCLS Documents. For more detailed source information,please refer to that document.

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Diagnostic specimen, n - Any human or animalmaterial that is to be used for diagnostictesting, including, but not limited to, excreta,secreta, blood and its components, tissue, andtissue fluids.

Reference range//Reference interval//(Normalrange) n - The range of test values expected fora designated population of individuals. (USCFR493 February 28, 1992) NOTE: Forexample, 95 percent of individuals that arepresumed to be healthy (or normal).

Reportable range, n - The range of test valuesover which the relationship between theinstrument, kit, or system's measurementresponse is shown to be valid. (US CFR493February 28, 1992)

Training, n - The education, instruction, ordiscipline of a person. NOTE: The term"training" is used in this document in a generalsense. Training is addressed in the discussionof safety issues and in the discussion of pre-and postanalytical variables.

Standard precautions, n - Those precautions(as defined and recommended by the Centersfor Disease Control and Prevention) to beobserved by operator during the collection andhandling of human biological specimens. (SeeSection 5.2.5.)

Wellness testing, n - Any diagnostic testingintended to aid in the recognition of asympto-matic/preclinical disease, or to confirm a stateof health.

4 Criteria for Choosing Tests

When choosing tests that will be performed aspart of a wellness program, consider testing fordisorders in which there is a high frequency ofoccurrence (e.g., heart diseases, cancer,hypertension, diabetes) and effectiveintervention, as well as for other disorders forwhich treatments are available. Also, considerusing tests that are inexpensive, easy toperform, reliable, and accurate.

5 Safety

5.1 Components of a Safe Environment

It is important that the testing program ensurea safe environment, which includes thefollowing components:

! Protection of operators, participants,bystanders, and observers from harm.

! Ability to respond to emergencies.

! Appropriate infection-control standards.

! Privacy of the participant and confiden-tiality of results.

! Availability by telephone of a consultantfamiliar with wellness testing issues, suchas test interpretation.

Key elements of a safe environment areaddressed in the following NCCLS documents:H3Procedures for the Collection of DiagnosticBlood Specimens by Venipuncture; M29Protection of Laboratory Workers fromInstrument Biohazards and Infectious DiseaseTransmitted by Blood, Body Fluids, and Tissue;and GP5Clinical Laboratory WasteManagement.

5.2 Safety Recommendations

5.2.1 Emergency Plan

A plan should be in place that will ensureimmediate access to appropriate services tohandle medical emergencies, such as faintingand excessive bleeding. Appropriate supplies,such as spirits of ammonia or fruit juice, shouldbe available for use in the treatment of faintingor other medical emergencies. If federal, state,or local ordinances require that operators becertified in cardiopulmonary resuscitation (CPR),an appropriate mechanism for meeting thisregulation should be included in the emergencyplan.

5.2.2 Incident Documentation and Reporting

Establish organizational operating procedures fordocumenting and reporting incidents, such asan exposure incident, i.e., a specific eye,mouth, other mucous membrane, nonintact


3

skin, or parenteral contact with blood or other puncture site, and C40Analytical Procedurespotentially infectious material that results from for the Determination of Lead in Blood andthe performance of an employee's duties. Urine.)1

5.2.3 Health Policies 5.2.5 Standard Precautions

Establish practices and procedures that maintain Because it is often impossible to know whichorganizational employee health policies and might be infectious, all patient blood specimensconform to state regulations concerning are to be treated with standard precautions. Forhealthcare workers. All pertinent infectious and specific precautions for preventing thecontagious diseases should be covered in these laboratory transmission of blood-borne infectionpolicies and practices. For example: from laboratory instruments and materials; and

! Where required by the sponsoring borne exposure, refer to NCCLS documentorganization or by local ordinance, operators M29Protection of Laboratory Workers fromshould be tested for tuberculosis (TB) and Instrument Biohazards and Infectious Diseasefound to have negative TB skin test or Transmitted by Blood, Body Fluids, and Tissue.negative chest film results. In the case ofa positive result for a TB skin test or chest These precautions include the followingfilm, take appropriate action as required by guidelines:the organization or local ordinance.

! Provide education and training on standards type of specimen collection.for protective clothing and equipment.NCCLS document M29Protection of Lab- ! Change gloves between patients.oratory Workers from Instrument Bio-hazards and Infectious Disease Transmitted ! Operators using spring-loaded lancetby Blood, Body Fluids, and Tissue, deals devices should replace the lancet andspecifically with these issues. platform or endcap after each use, unless

! Establish baseline hepatitis B antibody titers spring-loaded lancet devices withouton test operators and offer the hepatitis B replaceable platforms.vaccine. If an operator declines the offer ofthe vaccine, it should be documented. ! Use a 0.5%-sodium hypochlorite and water

! Follow standard precautions (see Section contaminated with blood and body fluids.5.2.5). This solution may be made by mixing 1

5.2.4 Infection-Control Standards of water.

Implement infection-control standards that are ! Keep the testing area clean.consistent with current regional regulations.Establish procedures for response in the case of ! Discard used material immediately after use.accidental exposure (e.g., a needlestick).

Using a vigorous rubbing technique, cleanse the closable, leakproof, puncture-resistantfinger of the participant with either iodophor or sharps container that is labeled "bio-isopropyl alcohol for 15 to 30 seconds, and let hazardous waste."the area dry completely before attempting afingerstick. This is a general recommendation. ! Process puncture-resistant sharps disposalMore stringent requirements may be necessary containers according to established safetyfor specific tests e.g., coagulation test, blood standards.glucose, and blood lead. (See NCCLS documentH4Procedures for the Collection of Diagnostic ! Discard nonsharp articles in a biohazardBlood Specimens by Skin Puncture which bag; do not mingle this refuse with food ordescribes the technique for cleansing the skin- other unrelated refuse.

recommendations for the management of blood-

! Use gloves for fingerstick and any other

the entire unit is disposable. Do not use

solution to clean surfaces that are

volume of household bleach with 9 volumes

! Dispose of capillary tubes and lancets in a

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! Dispose of infectious waste in compliancewith applicable regional regulations con-cerning medical waste.

5.3 Creation of an Organized TestingEnvironment that Facilitates Success

The physical environment in which wellnesstesting is performed is important to the successof the program. For example, well-plannedprograms for smooth handling of participantflow leave participants with favorableimpressions of the experience and, generally,contribute to an improved quality of outcome.Also, operators work and adhere to qualitycontrol procedures more effectively in such anenvironment.

This document is not a comprehensive plan forthe organization and operation of publicwellness-testing programs, although theseelements are important. Wellness-testingprograms should include the followingelements:

! Settings that provide easy access foreveryone (including rural and poor urbanpopulations, the elderly, and patients usingwheelchairs) and that are conducive tohandling the flow of participants. Thelayout should provide privacy duringsampling, ensure confidentiality of results,and promote communication betweenparticipants and staff.

! Adequate staffing and equipment tominimize the likelihood of a stressed,hurried environment that is not associatedwith high quality.

! A clean and appropriate location.

! A test system used as specified in themanufacturer's literature.

Venipuncture wounds resulting from specimencollection should be covered with a sterilegauze adhesive strip (bandage) followingsample collection. Keep participants in thetesting area until bleeding from the fingerstickor phlebotomy ceases.

Wellness-testing programs should be operatedin accordance with applicable federal, state, andlocal regulations.

6 Operator Training andResponsibilities

Give staff at public wellness-testing centerstraining that facilitates the performance of theirduties. They should be taught by healthcareprofessionals with experience in the detectionand measurement of analytes, and in themanagement of the information evaluated in awellness-testing environment. As informationand/or procedures change, training of staffshould continue. Training programs shouldinclude hands-on practice and testing ofcompetency, both on paper and in practice,followed by documentation of performance. Theassessment tool used should demonstrateachievement of a requisite level of knowledge,as well as skills in the tasks required.

6.1 General Training Recommendations

Educate all wellness-testing staff on thefollowing topics:

! Purpose and objectives of the testingprogram.

! Importance of professional appearance andconduct.

! Procedures to deal with emergencysituations, such as fainting and anxietyreactions.

! Methodology and importance of accuratemeasurements, careful reporting, and docu-mentation of wellness-testing activities.

! Safe setup and operation of the equipment.

! Infection control, hazardous waste dispo-sal, and other safety measures.

! Calibration of the equipment and reportablerange.

! Quality assurance standards and pro-cedures.

! Test-specific storage and preservation ofspecimens. When testing is provided at aremote testing site, the testing laboratorymust be identified.


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! Process and skills involved in education, are maintained; and that appropriatecounseling, classification, referral, and reference ranges are established.follow-up of participants.

! Written documentation of training. of results.

Because errors in measurement frequently ! Ensuring that information is available tooriginate in poor sampling methods, staff who participants on matters related to thecollect blood from participants should be quality, significance, and interpretation ofproperly trained and have documented test results. This information should becompetency when venipuncture is involved. developed and approved by a healthcareThey should have a clear understanding of skin- practitioner credentialed and skilled inpuncture and/or phlebotomy specimen- preparing patient information, particularly oncollection methodology. testing processes and on test interpretation.

Staff should receive education on and simple, clear language. demonstrate an understanding of safe tech-

b

6.2 Responsibilities of the Director

The director of a wellness-testing programperforms specific responsibilities. The directorshould be qualified to manage the operator whoperforms testing and should meet applicableregulatory requirements (e.g., in the U.S.,CLIA ). The director should be accessible to the2

staff for consultation, as needed. The directoris responsible for the overall operation of theprogram, including employing competentoperators, providing for accurate and reliabletest results, and assuring compliance withapplicable regulations. In addition, the directoris responsible for:

! Maintaining the quality of all aspects of thetesting process (preanalytic, analytic, andpostanalytic), including the effectiveness ofquality control, quality assurance, andproficiency testing programs.

! Determining the requirements for aparticipant consult form and the pertinentcontent as appropriate.

! Ensuring: that test systems are appropriateand provide the quality of results requiredfor the population tested; that performancecharacteristics have been verified; thatacceptable levels of analytic performance

! Ensuring medical review and interpretation

Educational information should be written in

the site is safe and appropriate for thetesting performed.

! Employing a sufficient number of testoperators who have the appropriateeducation, training, or experience andmonitoring their performance to ensurecompetency.

! Ensuring that an approved proceduremanual is available to operators.

! Ensuring that records are kept for a periodof time which is consistent with regulatoryrequirements and other legal consid-erations.

! Considering whether to survey participantsfor satisfaction with service and to find outwhether recommendations were followed.

6.3 Selection, Training, and Responsi-bilities of the Test Operator

6.3.1 Selection and Training of TestOperators

Every operator who performs testing forwellness programs should meet applicablefederal and state regulatory requirements foreducation, training, and experience. Beforeanalyzing specimens, every operator shouldhave documented education and trainingappropriate for the testing performed. Suchtraining should furnish the operator with thefollowing skills:

In the U.S., this should include education on the CDCb

recommendations for preventing the transmission ofinfectious disease in healthcare settings.

niques for infection control and prevention. ! Ensuring that the physical environment of

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! The skills required for proper specimen confidentiality, and reporting results. Eachcollection (including participant preparation, operator should perform only tests or functionsif applicable), labeling (e.g., full donor authorized by the director and for which thename, identification number of donor, person has the appropriate technical skills anddate/time of collection, identification of education, training, or experience.phlebotomist), handling, preservation,processing, transportation, storage, and Additional operator responsibilities include:disposal.

! The skills required to perform testing and processing, test analyses, and reportingprocedures, including proper kit or test results.instrument use, per the manufacturer'sinstructions. ! Adhering to quality control policies,

! The skills required to perform preventive instrument and method calibrations,maintenance, troubleshooting, and cali- performance and maintenance.bration procedures related to each testsystem. ! Following established corrective action

! The skills required to implement quality systems are not within establishedcontrol procedures and to verify the validity acceptable levels of performance.of participant results through the evaluationof control results. ! Identifying problems that could adversely

! A working knowledge of reagent stability, results and either correcting the problems orstorage, and preparation, as applicable to notifying superiors.the test methods.

! An awareness of the factors that affect test test systems deviate from establishedresults such as interfering substances: performance specifications.specimen turbidity and environmentalconditions.

Regardless of their background (e.g., as nurses,laboratory technicians, or technologists) alloperators should be trained appropriately.Training conducted by individuals experiencedin laboratory procedures and protocol shouldconsist of classroom instruction and directhands-on experience in: setup and operation ofthe test method or system; in detectingproblems; in performing required maintenance;and in performing quality control procedures.Operators should have an adequate, docu-mented, supervised field experience operatingthe devices before testing on their own. Pro-vide supplemental training where the qualityassurance program (see Section 7) detects adeparture from expected quality that istraceable to performance.

6.3.2 Responsibilities of the Operator

Test operators are responsible for specimencollection, processing, test performance,troubleshooting, maintaining patient

! Following procedures for specimen handling

documenting all quality control activities,

policies and procedures whenever test

affect test performance or reporting of test

! Documenting all corrective actions when

6.4 Training Staff Who Provide Educa-tional Information

Testing center operators who provideeducational information to participants shouldreceive training in the delivery of accurateeducational messages. This includes teachingskills for clear, credible, and persuasiveeducational counseling. The operator providingparticipant education should be skilled inproviding documentation on the referral andfollow-up process (see Section 9).

7 Quality Assurance (QA)

Written quality assurance (QA) policies andprocedures should be established to monitorand evaluate the ongoing and overall quality ofthe total testing process (preanalytic, analytic,and postanalytic). The quality assurancepolicies should be consistent with all applicableregulatory requirements. The QA programshould evaluate the effectiveness of the testingcenter's policies and procedures, identify and


7

correct problems, assure accurate and reliable ! Document and resolve problems intest results, and ensure the adequacy and communication between the programcompetency of the staff. Based on the results staff/operators and participants receivingof these evaluations, the director should then the results; and complaints received by theapprove and update all policies and procedures, program.as necessary. All QA activities should bedocumented. ! Document and assess problems identified

The QA program should provide an ongoing and take necessary action to preventmechanism to assess and revise the following recurrence.items, as necessary:

! Test-specific procedures for specimencollection, labeling, preservation, and trans-port; criteria and policies for accepting orrejecting specimens.

! Information to be obtained from partici-pants.

! The test result report and the accuracy,reliability, clarity and timeliness of reportingsystems; record storage and retrieval.

! Quality control policies and procedures plus

documented corrective actions taken whenproblems are identified, for example, withcontrol results, reference ranges, orreported results. Quality control proceduresand calibrations when required should beperformed at the testing site, and should beperformed by the same personnelperforming patient testing.

! Policies and procedures that ensure operatorcompetency.

! Written documentation of quality controland patient results, incident and otherrelevant information. Logs (records) shouldbe documented and the logs (records)should be available for inspection for aduration determined by the program.

! Evaluate and compare test results when thesame test is performed using more than onemethod or instrument, or in multiple testingsites.

! Identify and evaluate participant test resultsthat appear inconsistent with criteria, suchas age, sex, pertinent clinical data,distribution of overall test results, andrelationship to other test parameters, whenavailable.

during QA reviews, discuss them with staff,

8 Preanalytical Testing Considerations

Testing of participants in wellness programs isdifferent from most medical laboratory testing.Usually, the wellness test request is participant-initiated and, often, the participant is notassociated with a healthcare practitioner who isobligated to review results and take appropriateaction. Therefore, the testing program shouldprovide the medical reasoning necessary tochoose the appropriate tests and inform theparticipant about those tests. Information onparticipant preparation for testing shouldinclude any dietary, medication, and activityinstructions. These written instructions arespecific to each test. Written instructions abouttime, place, and organization of specimen-collection mechanisms, as well as participantpreparation should also be explicit in the publicrelations and promotional materials for eachevent.

The specimen-collection process should beorderly and organized. Respect the privacy ofparticipants. Provide participants who reactunfavorably to blood collection (phlebotomy orskin puncture) with a private, quiet place torecline while they regain composure. Enforceuniversal precautions procedures. For moreinformation on blood collection procedures,refer to NCCLS document H3Procedures forthe Collection of Diagnostic Blood Specimensby Venipuncture as well as NCCLS documentH4Procedures for the Collection of DiagnosticBlood Specimens by Skin Puncture.

Specimen labeling and preparation should ad-here to standard practices. Because samplingoccurs in a nonlaboratory setting, pay specialattention to time and temperature requirementsfor specimen centrifugation, transport, andstorage.

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9 Postanalytical Considerations andProviding Participant Information

The most important postanalytical consid-eration is the appropriate use of the wellnesstesting result. Participant-initiated testing isfrequently performed without a healthcarepractitioner who will accept responsibility foreach participant's result. The director isresponsible for the medical review of theresults.

The primary goal of medical review is to decidehow to advise the participant. The reviewprocess determines the content of that adviceand the timeliness or urgency of its delivery.Most participants can be described as "well,""worried but well," or "relatively asymptomaticwith an occult condition." It is rare toencounter a seriously abnormal result thatrequires that the participant be notifiedimmediately. However, a policy should exist forthat contingency. The participant has thefollowing choices:

! Do nothing with the recommendation.

! Review normal results with their physiciansat the time of their next regular appoint-ment.

! Make an immediate appointment with anappropriately credentialed healthcare practi-tioner to discuss the results.

The advice to the participant should provideclear guidance in choosing among thealternatives and should be developed in consul-tation with and approval by an appropriatelycredentialed healthcare practitioner. Take careto prevent a participant from unilaterallydeciding to alter compliance with previousphysician orders.

Protect the results of participant-initiated testingwith standard confidentiality policies. Resultscan be shared only with the participant'spermission. Results should not be given to ahealthcare practitioner not associated with thewellness program without specific permissionfrom the participant. Therefore, policies shouldexist that address transmission of theparticipant's results.

The participant rightfully expects to receiveinformative, interpretive information. Toprovide a result without addressing the medicalassessment of the result is to avoid legal andmedical responsibility, as well as to ignore theparticipant's appropriate expectations. Awellness letter should be developed providingparticipants with general and descriptivecomments about each test provided and thelanguage level appropriate for the targetedpopulation. The letter should be developed bysomeone skilled in effective risk communicationto consumers. For example it is suggested3,4

the letter include:

! the limitations of the test.

! normal/reference range of results.

! the interpretation of the test result(s).

! cautions to observe which may affect thetest result.

! associated risk factors.

! the need for physician follow up.

! a telephone number for additionalinformation (as available).

When specific abnormalities or combinations ofabnormalities are encountered, a participantrightfully expects to receive additionalinformation. Brief explanatory paragraphsshould be included with a wellness letter ifabnormalities are encountered. The participant3

needs to know if the abnormality requiresimmediate attention from a healthcare practi-tioner, attention at a convenient time from ahealthcare practitioner, or if it is of relativelylittle concern.

Records should be kept for a period of timewhich is consistent with regulatory require-ments and other legal considerations.


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References

1. Occupational Safety and HealthAdministration. Occupational Exposure toBloodborne Pathogens; Final Rule (29 CFRPart 1910.1030). Federal Register.December 6, 1991;235:64175-64182.

2. Regulations Implementing the ClinicalLaboratory Improvement Amendments of1988; Final Rule (42 CFR Part 405).Federal Register. February 28, 1992 (57 FR7002).

3. Witte DL, Angstadt DS, Schweitzer JK.Chemistry profiles in wellness programs:Test selection and participant outcomes.Clin Chem. 1988;34:1447-1450.

4. Witte DL. Wellness testing: Design and

experience of an established program. ClinLab Med. 1993;13:481-490.

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Summary of Comments and Subcommittee Responses

AST3-P: Wellness Testing Using IVD Devices; Proposed Guideline

General Comments

1. The guideline correctly points out the proliferation of wellness testing in a variety of settings, butfails to analyze who is providing the testing at such site. Consequently, it presents a very unevenlevel of detail. Much more discussion should be dedicated to: requirements of a wellness testingprogram, records required to be maintained on site vs. at the core laboratory, regulatory agencieswho may need to be involved with setting up and maintaining the site, some basic discussion ofthe complexity model from CLIA, the whole question of licensure in general.

! The subcommittee thanks the commenter and has incorporated revisions where appropriate.Revisions on maintaining records are located in Sections 6.2 and 9. Regulatory agencies are notlisted because they would vary from region to region and a compiled list would be difficult togenerate. The issue on licensure is also related to the local and regional regulatory requirements.A discussion of the complexity model from CLIA would be limited to the U.S. which would beinconsistent with NCCLSs objective of globalizing its documents.

2. The more common "wellness testing" site is the temporary "health fair." Again, most health fairsare sponsored by some sort of parent testing organization and testing is not typically performedon site. The guidelines should identify what procedures should be in place for remote specimencollection. If some of these sites do perform testing, several questions should be addressed bythe guideline, including: What procedures and records would need to be on site? Who should becustodian of testing records? What QC/QA practices should be followed for a temporary testinglocation. At what point does the result undergo medical review?

! The subcommittee thanks the commenter and has incorporated revisions regarding the concernsmentioned where appropriate. Revisions regarding remote specimen testing are in Section 6.1.Revisions regarding QC/QA practices are included in Section 7, bullet 4.

3. Overall, the document attempts to set guidelines for wellness testing in general. It is ourrecommendation that AST3-P be revised to address four types of wellness testing situations asdepicted in the following matrix.

Temporary Site Permanent Site

Testing performed on site X X

Testing not performed on site X X

! Section 5.3 was revised to emphasize that the subcommittee did not intend to provide acomprehensive plan for the organization and operation of a public wellness-testing plan. Theyalso believe that the requirements are the same and do not want to be repetitious. However, aftercarefully discussing this recommendation, specimen preservation has been added for those casesin which the specimens are not tested on site.

4. I could not find reference to the concept of informed consent of the participant. The informedconsent provides the wellness testing site an opportunity to describe the testing process and whatthe participant can expect. It is especially important to mention that, depending on the wellnessevent, blood may or may not be taken. An individual that comes for a "cholesterol screening"may be ready only for a dietary overview of the foods that he/she is consuming and will be verysurprised when blood is withdrawn from them and tested. Finally, a signed informed consent


11

form should cover many legal issues. An example included in the proposed guidelines would bevery helpful.

! Due to differences in regional requirements and specific test requirements, the subcommitteeencourages users to design their own consent form with the information described in the text.

5. This document is just another version, albeit easier to understand, of the CLIA test that appearsin the Federal Register. Cannot we as laboratorians add anything of value to the current federallaw to aid those individuals that are performing or directing wellness testing? There were a fewstatements, for instance "after sample collection, use bandages to cover the puncture site," thatI would think would be helpful. Drawing from my experience of directing a wellness program withno outside help, I would have liked to see examples of good workflow design, patient throughputdesign, checklists for training, checklists for pre- and post-wellness testing (checkinventory/supply, review QC), ideas for analyzers (throughput, batch vs random access) and theirdifferent demands.

Of most help would have been the sample follow-up letter to participants and suggested test-specific explanatory addenda for abnormal test results. Many of us who use NCCLS documentsgo directly to the examples and use these as our reference points.

! The subcommittee agrees that the document should provide aid to those individuals that areperforming or directing wellness testing and has tried to design AST3-A to do so. Thesubcommittee believes the suggested examples are beyond the scope of the document.

6. In my experience, wellness testing itself has not been performed by individuals with similartitles/credentials that appear on the members of the subcommittee. I realize the context of thisdocument is for the "Director" of the program but the document does not define the word. It isstated in the Foreword that the document is to "assist them (the Director) in implementing aquality wellness testing program." If NCCLS has decided to recognize only those individuals thatmeet the Director qualifications as defined in CLIA 88 then it should be stated. It has been myexperience that the individuals responsible for "directing" or implementing and working in thewellness testing arena are: RNs, nutritionists, LPNs, MTs, MLTs, phlebotomists, and medicalassistants. I understand that NCCLS Subcommittee on Wellness Testing should not necessarilyrequire all its subcommittee members to be individuals from these groups but at least onerepresentative would seem appropriate for this subcommittee. NCCLS may distribute thedocuments to these individuals but comments are entirely different from voting privileges.

! As part of the consensus review process, the subcommittee solicited as much input as possiblefrom all user groups, including individuals actually performing wellness testing and "directors" ofwellness testing programs. Use of the term "director" in this document is clarified in Section 6.2which recommends they meet applicable regulatory requirements.

Section 5.2.5

7. The ninth bullet, last should be "standards," not "standards."

! The editorial correction has been made.

8. The fourth bullet, on cleansing the finger is a part of a collection procedure, not universalprecautions. This could be included under 5.2.4 Infection-Control Standards.

! The fourth bullet has been moved to Section 5.2.4 and the following sentences have been added:This is a general recommendation. More stringent requirements may be necessary for a specifictest (e.g., blood lead).

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Section 5.3

9. "After sample collection, use bandages to cover the puncture site..." Fourth bullet: I wouldsuggest changing the wording to state "All puncture wounds resulting from specimen collectionmust be covered with a sterile gauze adhesive strip (bandage) following sample collection" (MassDPH Regulations on Public Screening). Some of our wellness testing sites used gauze alone (notbandaid like and without adhesive) and we found gauze lying on the floor down the hall from thesite. This incident caused a major infectious disease issue!

! The first sentence of the fourth bullet has been revised to incorporate the commenters suggestedwording.

Section 6.1

10. Second paragraph, last sentence - Change "sample-collection" to "specimen-collection" to beconsistent with other NCCLS documents.

! The commenters suggestion has been incorporated.

Section 6.2

11. Second bullet, last line - Add "(normal ranges)" between "ranges" and "are" to improve the clarityof the guideline by including new and old terminology.

! The subcommittee defined reference range in Section 3, Definitions.

12. This section is silent on "Reportable Range" which is part of CLIA requirements. Therefore, thesubcommittee may wish to address and/or include it in order to be consistent with federal code.Federal Register/Vol. 57, No. 40/Friday, February 28, 1992/Rules and Regulations/Page 7140:Reportable Range means the range of test values over which the relationship between theinstrument, kit, or systems measurements response is shown to be valid.

! In Section 6.1, the following new seventh bullet has been added: Calibration of the equipmentand reportable range. Reportable range has also been defined in Section 3: Definitions.

13. This section does not actually address professional qualifications for director of wellness testingprogram.

! In the Foreword and Section 6.2, the guideline emphasizes that the wellness program and thedirector should meet applicable regulatory requirements. Because these requirements may vary,the subcommittee encourages the user to inquire about the applicable regulatory requirements.

14. My reading of this statement appears to limit the review to a Physician (M.D., D.O.). It could bethat it is because of my hospital background that I interpreted this statement as a responsibilityof a physician. Although later in the document it is explained, this statement appears confusingas to what "medical review" means. Does "medical review" mean only a physician can reviewand interpret this result? Or does this mean that only a physician can review data generated atthe wellness site? Clearly, for many tests a physician reviewing and interpreting the results is notnecessary.

! In the fourth bullet, the subcommittee replaced "providing" with "ensuring."


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Section 6.3.1

15. First bullet - Insert "(e.g., full donor name, identification number of donor, date/time of collection,identification of phlebotomist)" between "labeling" and "handling" to help reduce specimenmisidentification.

! The commenter's suggestion has been incorporated.

16. Last bullet - Add "(e.g., interfering substances: specimen turbidity, environmental conditions)"between "factors" and "that" to emphasize the importance of recognizing and/or controllingvariables that can influence the accuracy of test results.


Section 6.3.2

17. Fourth bullet - Add "This includes the quarantine of test results until accuracy has been verified." This reminder of quarantining suspect results may help ensure the accuracy of reported assayvalues.

! The subcommittee believes that this statement would be redundant and that it is covered in otherplaces of the document.

Section 7

18. Survey participants for satisfaction with service and to find out whether recommendations werefollowed. This is especially important when the recommendation was to make an immediateappointment with a healthcare practitioner.

! The following bulleted statement has been added to Section 6.2. "Considering whether to surveyparticipants for satisfaction with service and to find out whether recommendations werefollowed."

19. Add the word "written" after the word "Establish." QA policies and procedures should be inwriting.


20. The QA program should also include a review of not only the criteria for unacceptable specimensbut also a policy for action to be taken if the specimen is unacceptable.

! The first bullet has been revised to: "Test-specific procedures for specimen collection, labeling,preservation, and transport; criteria and policies for accepting or rejecting specimens."

21. The document should have a mention that Quality Control (if required, i.e. for analyzers) shouldbe performed at the screening site. Many times I have found individuals wishing to perform theQC back at our hospital (sometimes the day prior), then bringing the instrument to the testing siteand then testing patients. Had something happened in transport? One would never know.

! The following sentence has been added to the fourth bullet: "Quality control procedures andcalibrations when required should be performed at the testing site."

22. If multiple analyzers/methods are used in one site there should be a correlation between themestablished. This is to avoid CLIA requirement problems for tests of moderate and highcomplexity and to ensure all stations agree with one another. Or, if follow-up will be performed

February 1999 NCCLS

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at the institution that is sponsoring the wellness testing has a laboratory, then a correlation shouldbe established between the testing site and the reference laboratory.

! This issue has been addressed in the seventh bullet.

Section 9

23. First paragraph - In the second sentence, change "healthcare practitioner" to "licensed physician."Healthcare practitioner" should be included in Section 3: Definitions, or a more recognizeddescription should be used in the text.

! The subcommittee does not agree with this suggestion because the statement is not specificallydirected towards physicians.

24. Second paragraph, sixth sentence - "The usual situation involves . . . . discuss the results." Thewhole sentence is somewhat difficult to read and fully understand. For example, "who "is"choosing to do nothing with the recommendation" is not clear.

! This sentence has been revised and divided into bullets.

25. I would like to see the more important issues bulleted and not mixed-in with flowing paragraphs.The proposed guidelines bullet other information but not the pre- and post-analyticalconsiderations.

! Section 9 has been revised and has incorporated bullets as suggested.

26. Fourth Paragraph: It would be helpful to a director of a wellness program if NCCLS gave someinformation to help outline what good interpretive information means and what should beincluded in general and descriptive comments.

Our state agency requires, and is good advice, all individuals to be provided with a confidentialwritten test report that includes pertinent educational materials including, but not limited to, thefollowing information:

the limitations of the test the interpretation of the test result(s) associated risk factors the need for physician follow up a telephone number for additional information (if additional information is available)

I would also suggest including:

normal/reference range of results cautions to observe which may affect the test result (could be covered under limitations of

the test

! The subcommittee agrees with the commenter's advice and has incorporated the above bulleteditems into Section 9.


Proposed- and tentative-level documents are being advanced through the NCCLS consensus process; therefore, readers should%

refer to the most recent editions.

15

Related NCCLS Publications%%

C40-P Analytical Procedures for the Determination of Lead in Blood and Urine; Proposed Guideline(1998). Guidance for the measurement of lead in blood and urine, including specimencollection, measurement by GFAAS and ASV, quality assurance, and quality control.

GP5-A Clinical Laboratory Waste Management; Approved Guideline (1993). GP5-A offers guidanceon the safe handling and disposal of chemical, infectious, radioactive, and physical wastegenerated in the clinical laboratory.

GP14-A Labeling of Home-Use In Vitro Testing Products; Approved Guideline (1996). Thisdocument contains specifications and recommendations for label preparation for over-the-counter in vitro testing products.

GP21-A Training Verification for Laboratory Operator; Approved Guideline (1995). The documentprovides background and recommends an infrastructure for developing a training verificationprogram that meets quality/regulatory objectives.

H3-A4 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; ApprovedStandard Fourth Edition (1998). This document provides procedures for the collection ofdiagnostic specimens by venipuncture, including line draws, blood culture collection, andvenipuncture in children.

H4-A3 Procedures for the Collection of Diagnostic Blood Specimens by Skin PunctureThird Edition;Approved Standard (1991). This document gives a detailed description and explanation ofproper collection and hazards to patients due to inappropriate specimen collection by skinpuncture procedures.

M29-A Protection of Laboratory Workers from Instrument Biohazards and Infectious DiseaseTransmitted by Blood, Body Fluids, and Tissue; Approved Guideline (1997). Provides guidanceon the risk of transmission of hepatitis viruses and human immunodeficiency viruses in anylaboratory setting; specific precautions for preventing the laboratory transmission of blood-borne infection from laboratory instruments and materials; and recommendations for themanagement of blood-borne exposure.

February 1999 NCCLS

16

NOTES


17

NOTES

NCCLS 940 West Valley Road Suite 1400 Wayne, PA 19087 USA PHONE 610.688.0100

FAX 610.688.0700 E-Mail:[email protected]. ISBN 1-56238-370-1

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