GP09-A Selecting and Evaluating a Referral Laboratory; Approved … · · 2018-03-31GP9-A Vol. 18 No. 15 Replaces GP9-T November 1998 Vol. 11 No. 20 Selecting and Evaluating a Referral

GP9-AVol. 18 No. 15Replaces GP9-T

November 1998 Vol. 11 No. 20

Selecting and Evaluating a Referral Laboratory; ApprovedGuideline

This guideline provides an outline of reasons and criteria for choosing a referral laboratory. A checklistfor evaluating potential referral laboratories is included to assist in the decision process.

ABC

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Vol. 18 No. 15 GP9-A

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Abstract

This guideline, Selecting and Evaluating a Referral Laboratory; Approved Guideline (NCCLS documentGP9-A), provides reasonable objective criteria to assist laboratory managers and directors with choosinga referral laboratory. The subcommittee that developed this guideline was comprised of laboratoryprofessionals from commercial and state referral laboratories, government agencies, accrediting bodies,and hospitals and medical centers. With the benefit of this broad-based experience, we attempted toprovide, primarily to laboratory managers and directors, an easily implemented, but thorough, procedurefor evaluating and choosing a laboratory where routine or special analyses could be carried out mosteffectively. In Section 2, the guideline outlines the reasons for choosing a referral laboratory, and inSection 3, the criteria for selection. The document also contains a checklist, many of whose pointscorrespond to the selection criteria covered in Section 3.

[NCCLS. Selecting and Evaluating a Referral Laboratory; Approved Guideline. NCCLS document GP9-A(ISBN 1-56238-357-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087, 1998.]

November 1998 NCCLS

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GP9-AISBN 1-56238-357-4

November 1998 ISSN 0273-3099


Volume 18 Number 15

Robert R. Rickert, M.D., ChairholderCarl H. Blank, Dr. P.H.Stephen J. BraseRoyal A. CrystalWilliam J. Hausler, Jr., Ph.D.Irwin J. Hollander, M.D.Peter Jatlow, M.D.Kenneth D. McClatchey, M.D., D.D.S.Joseph E. O'Brien, M.D.Raymond E. Vanderlinde, Ph.D.

ABC

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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 GP9-A— Selecting and Evaluating aReferral Laboratory; Approved Guideline. Copies of the current edition may be obtained fromNCCLS, 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 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 ©1998. The National Committee for Clinical Laboratory Standards.

Suggested Citation

NCCLS. Selecting and Evaluating a Referral Laboratory; Approved Guideline. NCCLS document GP9-A(ISBN 1-56238-357-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA,1998.

Proposed GuidelineNovember 1985

Tentative GuidelineDecember 1991

Approved GuidelineNovember 1998

ISBN 1-56238-357-4ISSN 0273-3099


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Committee Membership

Area Committee on General Laboratory Practices

Donald A. Dynek, M.D. Pathology Medical Services, P.C.Chairholder Lincoln, Nebraska

Stephen J. Sarewitz, MD. Valley Medical CenterVice Chairholder Renton, Washington

Subcommittee on Selection and Evaluation of a Referral Laboratory

Robert R. Rickert, M.D. St. Barnabas Medical CenterChairholder Livingston, New Jersey

Carl H. Blank, Dr.P.H. Wyoming Department of HealthCheyenne, Wyoming

Stephen J. Brase The Independent Pathology Institute, Inc.Lake Oswego, Oregon

Royal A. Crystal Health Systems Concepts, Inc.Rockville, Maryland

William J. Hausler, Jr., Ph.D. University of IowaIowa City, Iowa

Irwin J. Hollander, M.D. Grand View HospitalSellersville, Pennsylvania

Peter Jatlow, M.D. Yale New Haven HospitalNew Haven, Connecticut

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

Joseph E. O'Brien, M.D. Quest Diagnostics, IncorporatedTeterboro, New Jersey

Raymond E. Vanderlinde, Ph.D Baltimore, Maryland.

Advisors

Thomas A. Blumenfeld, M.D. Teaneck, New Jersey

Thomas V. DiSilvio, M.D. Clinical Laboratories, Inc.Throop, Pennsylvania

Paul E. Kalish, M.D. Misericordia Hospital Medical CenterBronx, New York

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Bernard E. Statland, M.D., Ph.D. National Reference LaboratoriesResearch Triangle Park, North Carolina

William B. Zeiler, M.D. Associated Pathology LaboratoriesPittsburgh, Pennsylvania

Marianne C. Watters, M.T.(ASCP) Parkland Memorial HospitalBoard Liaison Dallas, Texas

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 OCTOBER 1998)

Sustaining Members

American Association for Clinical ChemistryBayer CorporationBeckman Coulter, Inc.Becton Dickinson and CompanyCollege of American PathologistsDade Behring Inc.Ortho-Clinical Diagnostics, Inc.Pfizer IncRoche Diagnostics/Boehringer Mannheim Corp.

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.Assoc. Micro. Clinici Italiani- A.M.C.L.I.Australasian Association of Clinical BiochemistsBritish Society for Antimicrobial ChemotherapyCanadian Society for Medical Laboratory Science—Société Canadienne de Science de Laboratoire MédicalCanadian Society of Clinical ChemistsClinical Laboratory Management Association

College of American Centers for Disease Control and Pathologists PreventionCollege of Medical Laboratory Chinese Committee for Clinical Technologists of Ontario Laboratory StandardsCollege of Physicians and Commonwealth of Pennsylvania Surgeons of Saskatchewan Bureau of LaboratoriesCommission on Office Department of Veterans Affairs Laboratory Accreditation Deutsches Institut für NormungInstitut für Stand. und Dok. im (DIN) Med. Lab. (INSTAND) FDA Center for Devices andInternational Council for Radiological Health Standardization in FDA Division of Anti-Infective Haematology Drug ProductsInternational Federation of Federacion Bioquimica de la Clinical Chemistry Provincia (Argentina)International Society for Health Care Financing Analytical Cytology AdministrationItalian Society of Clinical Instituto Scientifico HS. Biochemistry Raffaele (Italy)Japan Assn. Of Medical Iowa State Hygienic Laboratory Technologists (Osaka) Manitoba HealthJapan Society of Clinical Massachusetts Department of Chemistry Public Health LaboratoriesJapanese Assn. Of Medical Michigan Department of Public Technologists (Tokyo) HealthJapanese Committee for Clinical National Association of Testing Laboratory Standards Authorities - AustraliaJoint Commission on National Health Laboratory Accreditation of Healthcare (Luxembourg) Organizations National Institute of StandardsNational Academy of Clinical and Technology Biochemistry National Institutes of HealthNational Society for Ohio Department of Health Histotechnology, Inc. Oklahoma State Department ofOntario Medical Association Health Laboratory Proficiency Testing Ontario Ministry of Health Program Saskatchewan Health- Ordre professionnel des Provincial Laboratory technologistes médicaux du South African Institute for Québec Medical ResearchRCPA Quality Assurance Swedish Institute for Infectious Programs PTY Limited Disease ControlSociedade Brasileira de Analises Clinicas Sociedade Brasileira de Patologia ClinicaSociedad Espanola de Quimica ClinicaVKCN (The Netherlands)

Government Members

Armed Forces Institute of Asséssor Pathology Avecor Cardiovascular, Inc.Association of State and Avocet Medical, Inc. Territorial Public Health Bayer Corporation - Elkhart, IN Laboratory Directors Bayer Corporation - Middletown,BC Centre for Disease Control VA

Industry Members

AB BiodiskAbbott LaboratoriesABC Consulting Group, Ltd.AccuMed International, Inc.Accumetrics, Inc.Amersham Pharmacia BiotechAmmirati Regulatory Consulting

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Bayer Corporation - Tarrytown, Fujisawa Pharmaceutical Co. Roche Diagnostics/Boehringer NY Ltd. Mannheim Corp. Bayer Corporation - West Gen-Probe Roche Diagnostic Systems Haven, CT Glaxo-Wellcome, Inc. (Div. Hoffmann-La Roche Bayer-Sankyo Co., Ltd. Greiner Meditech, Inc. Inc.)Beckman Coulter, Inc. Health Systems Concepts, Inc. Roche Laboratories (Div.Beckman Instruments (Japan) Helena Laboratories Hoffmann-La Roche Inc.) Ltd. Hoechst Marion Roussel, Inc. ROSCO DiagnosticaBecton Dickinson and Company Hybritech, Incorporated The R.W. JohnsonBecton Dickinson Consumer Hycor Biomedical Inc. Pharmaceutical Research Products I-STAT Corporation InstituteBecton Dickinson Integ, Inc. Sarstedt, Inc. Immunocytometry Systems International Biomedical Schering CorporationBecton Dickinson Italia S.P.A. Consultants Schleicher & Schuell, Inc.Becton Dickinson Microbiology International Technidyne Second Opinion Systems Corporation SenDx Medical, Inc.Becton Dickinson VACUTAINER Kendall Sherwood-Davis & Geck Showa Yakuhin Kako Company, Systems Labtest Sistemas Diagnosticos Ltd.bioMérieux Vitek, Inc. Ltda. SmithKline BeechamBiometrology Consultants LifeScan, Inc. (a Johnson & CorporationBio-Rad Laboratories, Inc. Johnson Company) SmithKline Beecham (NZ) Ltd.Bio-Reg Associates, Inc. LifeSign, LLC SmithKline Beecham, S.A.Biosite Diagnostics Lilly Research Laboratories SmithKline Diagnostics, Inc.Biotest AG Luminex Corporation (Sub. Beckman Instruments,Boehringer Mannheim GmbH Mallinckrodt Sensor Systems Inc.)Bristol-Myers Squibb Company Medical Device Consultants, Streck Laboratories, Inc.Canadian Reference Laboratory Inc. Sysmex Corporation Ltd. Medical Laboratory Automation TOA Medical ElectronicsCASCO•NERL Diagnostics Inc. Vetoquinol S.A.Checkpoint Development Inc. MediSense, Inc. Vysis, Inc.ChemTrak Merck & Company, Inc. Wallac OyChiron Diagnostics Corporation Neometrics Inc. Warner-Lambert CompanyChiron Diagnostics Corporation - Nissui Pharmaceutical Co., Ltd. Wyeth-Ayerst International Operations Nippon Becton Dickinson Co., Xyletech Systems, Inc.Chiron Diagnostics Corporation - Ltd. YD Consultant Reagent Systems Norfolk Associates, Inc. Yeongdong Pharmaceutical Clinical Lab Engineering North American Biologicals, Inc. Corp.COBE Laboratories, Inc. OBC Associates ZenecaCombact Diagnostic Systems Olympus Corporation Ltd. Optical Sensors, Inc.Control Lab (Brazil) Organon Teknika CorporationCosmetic Ingredient Review Ortho-Clinical Diagnostics, Inc. Cytometrics, Inc. (England)CYTYC Corporation Ortho-Clinical Diagnostics, Inc. Dade Behring Inc. - Deerfield, IL (Raritan, NJ)Dade Behring Inc. - Glasgow, Ortho-Clinical Diagnostics, Inc. DE (Rochester, NY) Dade Behring Inc. - Marburg, Otsuka America Pharmaceutical, Germany Inc.Dade Behring Inc. - Miami, FL Oxoid Inc.Dade Behring Inc. - Oxoid LTD (U.K.) Sacramento, CA Pfizer IncDade Behring Inc. - San Jose, Pharmacia & Upjohn CA Procter & GambleDAKO A/S Pharmaceuticals, Inc.Diagnostic Products Corporation The Product Development GroupDiametrics Medical, Inc. Radiometer America, Inc.DiaSorin Radiometer Medical A/SEiken Chemical Company, Ltd. David G. Rhoads Associates, Enterprise Analysis Corporation Inc.Fort Dodge Animal Health Rhône-Poulenc Rorer

Trade Associations

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


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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. Anthony’s Health Network (TX)Baystate Medical Center (MA)Brazileiro De Promocao (Brazil)Brazosport Memorial Hospital (TX)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)Bullhead Community Hospital (AZ)Calgary Laboratory Services (Calgary, AB, Canada)Cambridge Hospital (MA)Capital Health System at Fuld (NJ)Central Kansas Medical CenterChildren’s Hospital (LA)Children's Hospital Medical Center (Akron, OH)Clendo Lab (Puerto Rico)Colorado Mental Health Institute at PuebloCommonwealth of KentuckyCommunity Medical Center (NJ)CompuNet Clinical Laboratories (OH)Consolidated Laboratory Services (CA)Covance CLS (IN)Detroit Health Department (MI)

Duke University Medical Center Louisiana State University (NC) Medical CenterDuzen Laboratories (Turkey) Lutheran Hospital (WI)E.A. Conway Medical Center Maccabi Medical Care and (LA) Health Fund (Israel)Elmhurst Memorial Hospital (IL) Main Line Clinical Laboratories, Emory University Hospital (GA) Inc. (PA)Fairview-University Medical Massachusetts General Hospital Center (MN) MDS Metro Laboratory Services Federal Medical Center (MN) (Burnaby, BC, Canada)Florida Hospital Alta Monte MDS-Sciex (Concord, ON, Florida Hospital East Orlando Canada)Foothills Hospital (Calgary, AB, Med-Chem Laboratories Ltd. Canada) (Scarborough, ON, Canada)Grady Memorial Hospital (GA) Medical Center Hospital (TX)Guthrie Clinic Laboratories (PA) Medical College of Virginia Hacettepe Medical Center Hospital (Turkey) Memorial Medical Center (LA)Harris Methodist Fort Worth Memorial Medical Center (IL) (TX) Mercy Health System (PA)Harris Methodist Northwest Mercy Hospital (NC) (TX) Methodist Hospital (TX)Hartford Hospital (CT) Methodist Hospital IndianaHealth Alliance Laboratory (OH) Methodist Hospitals of MemphisHealth Sciences Centre (TN) (Winnipeg, MB, Canada) Monte Tabor-Centro Italo- Hoag Memorial Hospital Brazileiro De Promocao (Brazil) Presbyterian (CA) Montefiore Medical Center (NY)Holmes Regional Medical Center Montreal Children’s Hospital (FL) (Canada)Holzer Medical Center (OH) Mount Sinai Hospital (NY)Hopital de Chicoutimi Mount Sinai Hospital (Toronto, (Chicoutimi, PQ, Canada) Ontario, Canada)Hopital Saint Pierre (Belgium) National Genetics Institute (CA)Hunter Area Pathology Service Naval Hospital Cherry Point (NC) (Australia) Nebraska Health System International Health New Britain General Hospital Management Associates, (CT) Inc. (IL) New England Medical Center Intermountain Health Care Hospital (MA) Laboratory Services (UT) New Hampshire Medical John Randolph Hospital (VA) LaboratoriesKaiser Permanente (CA) The New York Blood Center Kenora-Rainy River Regional New York State Department of Laboratory Program (Dryden, Health Ontario, Canada) New York University Medical Klinicni Center (Slovenia) CenterLa Rabida Children’s Hospital NorDx (ME) (IL) North Carolina Laboratory ofLabCorp (NC) Public HealthLaboratoire de Santé Publique North Coast Clinical Laboratory, du Quebec (Canada) Inc. (OH)Laboratory Corporation of North Shore University Hospital America (NJ) (NY)Lancaster General Hospital (PA) Northwestern Memorial Hospital Langley Air Force Base (VA) (IL)Loma Linda University Medical Center (CA)

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Ohio State University Hospitals St. Mary Medical Center (CA) University Hospital (Gent)Olin E. Teague Medical Center St. Mary of the Plains Hospital (Belgium) (TX) (TX) University Hospital (London, Our Lady of Lourdes Hospital St. Vincent’s Hospital Ontario, Canada) (NJ) (Australia) University Hospital ofOur Lady of the Resurrection San Francisco General Hospital Cleveland (OH) Medical Center (IL) (CA) The University Hospitals (OK)Pathology Associates Sarasota Memorial Hospital (FL) University of Medicine & Laboratories (CA) Seoul Nat’l University Hospital Dentistry, NJ UniversityPermanente Medical Group (CA) (Korea) Hospital PLIVA d.d. Research Institute Shanghai Center for the Clinical University of Michigan (Croatia) Laboratory (China) University of the Ryukyus Polly Ryon Memorial Hospital Shands Healthcare (FL) (Japan) (TX) SmithKline Beecham Clinical University of Virginia MedicalProvidence Health System (OR) Laboratories (GA) CenterProvidence Medical Center (WA) South Bend Medical Foundation University of WashingtonQueen Elizabeth Hospital (Prince (IN) UPMC Bedford Memorial (PA) Edward Island, Canada) South Western Area Pathology U.S. Army Hospital, HeidelbergQueensland Health Pathology Service (Austraila) UZ-KUL Medical Center Services (Australia) Speciality Laboratories, Inc. (Belgium)Quest Diagnostics (PA) (CA) VA (Albuquerque) MedicalQuest Diagnostics Incorporated Stanford Health Services (CA) Center (NM) (NJ) Stormont-Vail Regional Medical VA (Denver) Medical Center Quintiles Laboratories, Ltd. (GA) Center (KS) (CO)Regions Hospital Sun Health-Boswell Hospital VA (Indianapolis) Medical CenterResearch Medical Center (MO) (AZ) (IN)Riyadh Armed Forces Hospital Sunrise Hospital and Medical VA (Tuskegee) Medical Center (Saudi Arabia) Center (NV) (AL)Saint Mary’s Regional Medical Sutter Health (CA) ViroLogic, Inc. (CA) Center (NV) The Toledo Hospital (OH) ViroMed Laboratories, Inc. (MN)St. Alexius Medical Center (ND) Tri-City Medical Center (CA) Walter Reed Army Institute of St. Anthony Hospital (CO) Twin Lake Regional Medical Research (MD)St. Boniface General Hospital Center Warde Medical Laboratory (MI) (Winnipeg, Canada) UCSF Medical Center (CA) Warren Hospital (NJ)St. Francis Medical Center (CA) UNC Hospitals (NC) Watson Clinic (FL)St. John Hospital and Medical Unilab Clinical Laboratories (CA) William Beaumont Hospital (MI) Center (MI) United Clinical Laboratories (IA) Williamsburg Community St. John Regional Hospital (St. University of Alabama - Hospital (VA) John, NB, Canada) Birmingham Hospital Wilford Hall Medical Center (TX)St. Joseph Hospital (NE) University of Alberta Hospitals Wilson Memorial Hospital (NY)St. Joseph’s Hospital - (Canada) Winchester Hospital (MA) Marshfield Clinic (WI) University of Chicago Hospitals Winn Army Community Hospital St. Luke’s Regional Medical (IL) (GA) Center (IA) University of Florida York Hospital (PA)St. Luke’s-Roosevelt Hospital University Hospital (IN) Zale Lipshy University Hospital Center (NY) (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. Abbott LaboratoriesCosmetic 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 Boehringer Mannheim GmbH Marianne C. Watters,Sisters of Charity Health Care M.T.(ASCP) System Tadashi Kawai, M.D., Ph.D. Parkland Memorial Hospital

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

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

University of Wisconsin

Radiological Health Donald M. Powers, Ph.D.

International Clinical Pathology

and Prevention

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Contents

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

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

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

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

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

1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 Reasons for Choosing a Referral Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2.1 Unique or Unusual Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.2 Backup Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.3 Routine Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Criteria for Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3.1 Quality of Referral Laboratory Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Efficiency of Referral Laboratory Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Appendix. Referral Laboratory Evaluation Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Summary of Comments and Subcommittee Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Related NCCLS Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13


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Foreword

A clinical laboratory often requires the assistance of an outside facility or facilities to perform uniqueor unusual services, as a backup service, or for routine services that the referring (primary) laboratorydoes not perform. Choosing a referral laboratory can be tedious, time-consuming, and difficult. Itrequires thorough research into the options available to today's laboratory director. This universal needfor referral laboratory services underscores the need for guidelines to follow when choosing theseservices.

Deciding which laboratory to use can be based on several factors (e.g., references, cost, turnaroundtime, salesperson claims, proficiency, proximity, or "gut feelings"). Frequently it is only one of thesecriteria that is the deciding factor. While the cost of referral laboratory services may be an importantconsideration, the selection of a referral laboratory should be based primarily on the quality of servicesprovided.

This guideline outlines steps to be used when evaluating a referral laboratory. The reasons for choosinga referral laboratory are outlined in Section 2. The criteria for selection are presented in Section 3 andincludes information on how to evaluate the quality of referral laboratory services, facilities, equipment,personnel, quality control protocol, quality assurance/improvement activities, and instrumentmaintenance. This is followed by information on evaluating referral laboratories with regard toefficiency, scope of testing, specimen collection, test ordering, transportation, turnaround time, andresult reporting.

This guideline will be useful and applicable both for selecting a referral laboratory and for the ongoingmonitoring and evaluation of the selected laboratory.

Key Words

Referring (primary) laboratory, quality control, evaluation, selection.

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1

Selecting and Evaluating a Referral Laboratory; Approved Guideline

1 Introduction

Nearly every clinical laboratory must use theservices of a referral laboratory to process someportion of its workload; no formal and generallyavailable criteria or guidelines have beendeveloped to help in the selection process. Thedirector of the referring laboratory is responsiblefor selecting a referral laboratory and for itsongoing evaluation based on objective evidenceof acceptable quality and responsiveness inconsultation with the institutional medical staffor physician clients where appropriate.

Laboratories that must select a referrallaboratory will benefit from guidance whichemphasizes comprehensive yet relevant criteria.Potential referral laboratories can also useguidance to evaluate internal operations andtheir ability to meet the needs of the primaryreferring laboratory.

1.1 Scope

This document provides guidance whichemphasizes relevant and comprehensive criteriato aid laboratories in the process of selecting areferral laboratory. Similarly, potential referrallaboratories will benefit from having a set ofguideposts emphasizing relevant criteriaaccepted by consensus, to aid in evaluating andimproving the quality of their operations.

This guideline presents objective criteria forchoosing a referral laboratory and it provides achecklist to facilitate the process of selection.

2 Reasons for Choosing a ReferralLaboratory

Common reasons for sending specimens to areferral laboratory are:

2.1 Unique or Unusual Service

The referral laboratory may provide a "one-of-a-kind" analysis or perform tests that arerequested infrequently of the primary laboratory.

A referral laboratory might also be asked toconfirm unusual or unexpected results obtainedby the primary laboratory.

2.2 Backup Service

The referral laboratory may be asked to provideboth routine and esoteric services when a short-term interruption of service at the referringlaboratory is caused by instrument breakdown,unavailability of personnel, sudden increase involume, or any other unscheduled orunanticipated situation.

2.3 Routine Service

The referral laboratory may perform routinetests on an ongoing basis — tests which maybe fundamental services but are not duplicatedby the referring laboratory; or routine tests notperformed during normal hours of operationsuch as nights, holidays, and weekends.

3 Criteria for Selection

Regardless of the nature of referral servicesrequested by the primary laboratory, theselection criteria fall into three major relatedareas: quality of laboratory service, costeffectiveness, and efficiency of service. Whilethe cost of referral laboratory services may bean important consideration, the selection of areferral laboratory should be based primarily onthe quality of services provided.

3.1 Quality of Referral LaboratoryService

Although the assessment of quality is difficult,an objective evaluation can be made using asystematic approach. The referral laboratoryshould expect, permit, and encourage an on-siteevaluation of its facility. On-site laboratoryevaluation during peak operating hours isrecommended and appropriate. Consider thefollowing criteria in evaluating quality.

3.1.1 Facilities and Equipment

(1) Determine whether the equipment,supplies, and instrumentation areconsistent with the scope and volumeof testing being conducted.

(2) During an on-site visit, examine thephysical facility, general level of

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housekeeping, adherence to determine whether the proceduresound laboratory safety manuals meet the guidelines of NCCLSprinciples, and appearance, document GP2— Clinical Laboratoryattitude, and general demeanor Procedure Manuals.of the laboratory staff.Although the latter is a Also review test procedures in use.subjective determination, thedecorum of the laboratory may 3.1.2.3 External Quality Assessment Activitiessignificantly influence the (EQAS)quality of laboratory work.

3.1.2 Availability of Documents the records of its participation in

The referral laboratory should willingly testing programs. demonstrate the quality of its service bysupplying information in several categories of (2) A documented program for review oflaboratory operation. If the referring laboratory proficiency test results and a record ofdesires to review any documents or manuals, any corrective action taken should bethis may be accomplished during the onsite visit available. of the referral laboratory.

3.1.2.1 Personnel agree to split testing of specimens by

Inspect the qualifications of the referrallaboratory's director, professional staff, and (4) Information on participation in voluntaryconsultants. Information should include but not accreditation programs and certificationbe limited to: or licensure, where appropriate, by

(1) Educational experience cies should also be made available.

(2) Licensure, when appropriate (5) The referring laboratory must ascertain

(3) Certification

(4) Participation in continuing educationalactivities 3.1.2.4 Instrument Maintenance

(5) Significant areas of special expertise. (1) Examine documents on routine

3.1.2.2 Internal Quality Control records.

Review records of internal quality control (2) Determine whether the instrumentationprograms, including: in use is appropriate for the scope and

(1) Appropriateness and quality of testmaterials 3.1.2.5 Client Satisfaction

(2) Frequency of insertion of appropriate Although reputation may be a very subjectivequality control materials into test runs indicator of quality, valuable information may be

(3) Tolerance limits laboratory should provide the names of clients

(4) Appropriate statistical records

(5) Procedure manuals and the relatedsection of the Evaluation Checklist to

(1) The referral laboratory should provide

pertinent interlaboratory proficiency

(3) If requested, the laboratory should

the prospective referring laboratory.

various governmental/regulatory agen-

that the referral laboratory is

a

instrument maintenance and repair

volume of testing being referred.

gained from current clients. The referral

In the United States, the referral laboratory must bea

CLIA-88 certified for high complexity testing in thespecialty/subspecialty where required and appropriate.

certified/accredited/licensed where re-quired and appropriate.


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as references. The referral laboratory should (1) Quantity of specimen required also be willing to describe its internal programto assess and assure client satisfaction. (2) Special handling needs, including sepa-

3.1.2.6 Other Quality Assurance/ImprovementIssues (3) Labeling

All laboratories should have a program to assess (4) Use of anticoagulants or preservativesquality, identify opportunities for improvement,and implement improvements. The best (5) Desired clinical information.laboratories actively involve all employees inquality planning and assurance activities. A The actual procedure for test ordering should bereview of quality assur-ance/improvement clearly defined. The referral laboratory shouldmeetings may demonstrate the types of issues have clearly defined criteria for unacceptablediscussed and how resolution was achieved by specimens and should document its adherencethe laboratory. to its policy for rejecting specimens. Changes in

3.2 Efficiency of Referral LaboratoryService

When evaluating acceptable efficiency of areferral laboratory, the scope of availabletesting, specimen collection procedures, testordering, transportation, turnaround time, andreporting of results, including critical(imminently life threatening) values, should beconsidered. The acceptability of each of theseelements will vary depending on the individualneeds of the referring laboratory.

3.2.1 Scope of Available Testing

The importance of the variety of tests offeredby a referral laboratory will be greatly influencedby individual requirements. Some referringlaboratories may need a specialty laboratoryoffering very limited procedures, while otherswill seek a facility with a full range of services.Before selecting a referral laboratory, clearlydefine specific needs. An acceptable referrallaboratory may have to refer to anotherlaboratory in order to provide complete referralneeds. If the referral laboratory refersspecimens to another laboratory, thelaboratory(ies) should be identified, theirqualifications should be made available, andtheir name should appear on the report form.

3.2.2 Specimen Collection and Test Ordering

The referral laboratory should providecomprehensive instructions for properlypreparing patients and collecting specimens,including:

rate pediatric requirements if indicated

specimen requirements should becommunicated to referring laboratories inadvance. In addition, the referral laboratoryshould define the mechanism whereby the clientis notified of changes in normal referenceranges and must include these changes incurrent reports.

3.2.3 Transportation

The method of transporting specimens from thereferring to the referral laboratory should beclearly defined. If a courier service is used,establish satisfactory pick-up schedules. Themechanism of specimen transport must satisfythe requirements of the referring laboratory andensure the integrity of patient specimens.Special requirements, such as for transportationof frozen specimens, should be addressed andclearly defined.

3.2.4 Turnaround Time

Although the needs of an individual referringlaboratory may vary, the expected interval fromreceipt of specimen to reporting of resultsshould be published. Unanticipated delays inreporting results should be communicated tothe referring laboratory. Current or formerclients should be consulted to document thereferral laboratory's compliance with its statedpolicy. If limiting specific testing to certain daysof the week will impact turnaround time, thisinformation should be available to the referringlaboratory.

3.2.5 Communications Systems

Referral laboratories should use a standardizedorder entry or results reporting communication

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protocol/systems. Communication capabilities (7) The referral laboratory must have ashould be acceptable to meet the needs of the policy concerning corrected andreferring laboratory (e.g., bi-directional amended reports.interfaces, result printer, and referral laboratorycomputer connection). (8) The referral laboratory should have a

3.2.6 Reporting of Results and Interpretations ing of results to patients which cites as

The importance of the method of reporting test regulations which may be applicable.results will depend on the needs of the This policy should be provided to theprospective client laboratory. referring laboratory.

Note: Timely communication is a significantissue in all relationships between the referringand the referral laboratories.

(1) Automated data communicationsystems may be required by someclients while others may need lesssophisticated reporting methods.Referral laboratory reports shouldindicate the name of the referringlaboratory and the name and address ofthe laboratory where the tests wereactually carried out, whether the reportsare charted directly or recopied.

(2) Reports, whether written, printed,electronic, or verbal, should include ageand sex adjusted reference rangesand/or other therapeutic or diagnosticreference ranges, where possible.

(3) Critical (imminently life threatening)values should be immediatelycommunicated to the referring labora-tory. Other unexpected or unusualresults should be communicated in atimely fashion in the context of theclinical findings.

(4) The referral laboratory should respond

promptly to inquiries concerning testresults.

(5) The referral laboratory should alsoprovide the client with expert consultingservice if necessary.

(6) The referral laboratory should alsoprovide the client with its writtenpolicies for dealing with inappropriate/compromised specimens.

written policy concerning direct report-

appropriate, any local, state, or federal

4 Summary

The needs of the laboratory seeking theservices of a referral laboratory may varywidely. The primary referring laboratory shouldtherefore clearly understand its ownrequirements before initiating the selectionprocess. The referring laboratory shouldevaluate all areas where referral testing may berequired. It may be necessary to select morethan one referral laboratory to ensure acceptabletesting in all required areas.

The referring laboratory must select a referrallaboratory that meets the current standards ofclinical laboratory practices. Useful selectioncriteria permit a systematic evaluation and aresufficiently flexible to satisfy the divergentneeds of individual laboratories. Theseguidelines will facilitate a systematicassessment of both the quality and efficiency ofpotential referral laboratory services.

It should be noted that evaluation of a referrallaboratory must be an ongoing process, and itis therefore suggested that the referringlaboratory set up meetings at regular intervalswith the referral laboratory to review all of theabove.

The Appendix which follows was designed toassist in the process of selection — both on-siteand off-site, and may be useful in the ongoingevaluation of referral laboratory services.


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Appendix. Referral Laboratory Evaluation Checklist(This checklist is designed to provide a guide and contains suggestions for useful areas of inquiry during the evaluation process.It is not intended to be a scoring system.)

I. Licensure/Certification/Accreditation

Accreditation orAuthority Certification # Expires

College of American Pathologists _______________ _________

Commission on Office Laboratory Accreditation _______________ _________

Joint Commission on Accreditation ofHealth Care Organizations _______________ _________

Health Care Financing Administration Regulations for Medicare, Medicaid, and CLIA Program _______________ _________

American Association of Blood Banks _______________ _________

State of __________ (if applicable) _______________ _________

Municipality of __________(if applicable) _______________ _________

Other Applicable International Accrediting Agencies _______________ _________

As appropriate, reviewed documents pertaining to Licensure/Certification/Accreditation

II. Laboratory Director

Name(s)

Credentials

Involvement: Active Full-Time Active Part-Time Consultant

III. Personnel (See Section 3.1.2.1)

Resumes/curricula vitae obtained on all key technical directors Yes _____ No _____

Number of: Technicians _____ Technologists Doctoral Level Scientists

Number of Full Time Employees (FTE)

Does the laboratory have a qualified supervisor during all hours of operation?Yes _____ No _____

Are specific staff members assigned to assist you at all times?Yes _____ No _____

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Does the technical staff have expertise in the areas required?Yes _____ No _____

Does the technical staff receive continuing education on ongoing basis and is it documented?Yes _____ No _____

IV. Internal Quality Control Activities (See Section 3.1.2.2)

Is there a written, organized, and comprehensive Quality Control program and is it properlydocumented?

Yes _____ No _____

Are procedure manuals standardized and complete and are all procedures reviewed annuallyaccording to NCCLS document GP2— Clinical Laboratory Technical Procedure Manuals?

Yes _____ No _____

Are test materials (reagents, standards, controls, equipment, and methodology) appropriate forthe type(s) of test(s) being performed?

Yes _____ No _____

Are standards and controls used in appropriate frequency?Yes _____ No _____

Are tolerance limits established for procedures?Yes _____ No _____

Is there a process for remedial action when tolerance limits are exceeded?Yes _____ No _____

Are adequate statistical data produced?Yes _____ No _____

Are instruments receiving timely preventive maintenance and is maintenance recorded properly?Yes _____ No _____

V. External Quality Assessment (See Section 3.1.2.3)

Reviewed results of most recent proficiency testing?Yes _____ No _____

For deficiencies noted in the above, were appropriate and timely corrective actions taken?Yes _____ No _____

Will the referral laboratory agree to "split trials" to compare their results with current laboratorybeing utilized?

Yes _____ No _____


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VI. Reputation (See Section 3.1.2.5)

Will the laboratory provide a list of clients for you to contact? Yes _____ No _____

Length of time served by laboratory _______________________

Type of client (e.g., hospital, POL, independent laboratory)

General observation of client regarding service:Poor ____ Average ____ Above Average ____ Superior ____

Does the referral laboratory have a program to assess and assure client satisfaction?Yes _____ No _____

VII. Efficiency of Referral Service

A. Scope of Available Testing (See Section 3.2.1)

Does the laboratory offer a sufficient range of services to satisfy client?Yes ____ No ____

(If no, the referring laboratory may choose to end the evaluation.)

Does the laboratory perform a sufficient volume of all procedures that client will referto be proficient?

Yes ____ No ____

B. Specimen Collection/Test Ordering (See Section 3.2.2)

Does the laboratory clearly define in writing comprehensive instructions for preparationand collection of specimens as well as criteria for rejection of unsatisfactory specimens?

Yes____ No____

C. Transportation (See Section 3.2.3)

Does the laboratory clearly define in writing comprehensive instructions for transportand shipment of specimens to include:

Preparation _____Packaging _____Labeling _____Storage _____Pick-up Times _____

What procedures do they follow if an emergency is identified by the client?

D. Turnaround Time (See Section 3.2.4)

Does the laboratory provide a written statement of expected turnaround time for everyprocedure performed?

Yes _____ No _____

E. Communications Systems

Does the referral laboratory use a standardized order entry or results reporting communicationprotocol/system?

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F. Results Reporting (See Section 3.2.6)

1. Critical Values

Obtain written protocol for what critical values are called, the mechanism, andthe timing.

2. Report Review

Does the laboratory have a mechanism whereby data which are generated arereviewed for possible errors?

Yes ____ No ____(If no, the referring laboratory may choose to end the evaluation.)

3. Does the laboratory respond promptly to inquiries concerning test results andprovide expert consultative service if necessary?

4. Does the laboratory have a written policy for dealing withinappropriate/compromised specimens?

5. Does the laboratory have a policy concerning corrected and amended reports?

6. Does the laboratory have a policy for reporting results directly to the patients?

VIII. Consultation

Does the laboratory provide client consultation services on a daily basis as follows:

Client Services Yes ____ No ____Technical Services Yes ____ No ____Medical Consultation Yes ____ No ____

Are these services available to you 24 hours a day?Yes ____ No ____


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Summary of Comments and Subcommittee Responses

GP9-T: Selecting and Evaluating a Referral Laboratory; Tentative Guideline

General

1. This document does a good job of “overall” referral issues.

! The subcommittee appreciates the comment.

2. This appears to be a one-time selection process. Criteria for ongoing or annual (biannual)evaluation may be beneficial.

! The subcommittee revised the Introduction to emphasize that this document can be used forselecting a referral laboratory and for its ongoing evaluation. The last sentence of Section 4 hasalso been revised to emphasize that the checklist can be used for the ongoing evaluation of areferral laboratory as well as assist in the selection process.

3. The document might be reorganized at the strategic level with information categorized intothree broad activities: (The commenter provided examples of these activities)

# Risk Management# Quality Assurance# Utilization Review

! While the subcommittee believes the commenter’s examples of risk management, qualityassurance, and utilization review are valid, these activities are beyond the scope of thedocument. However, where appropriate and in the interest of the referring laboratory, theprocess of selecting a referral laboratory may include considerations related to risk managementand utilization review.

4. The document could be broadened to proceed from its initial goal of effective evaluation toinclude the following phases:

# Appropriateness of Referral# Initial Evaluation# Negotiation and Assignment of Responsibility and Authority# Implementation# Ongoing Surveillance

Choosing and using a reference laboratory should be done as if it were a new instrument beingbrought into the laboratory proper.

! The subcommittee believes the document addresses these issues. Emphasis has been addedto the Foreword, Introduction, and Section 4 that this document can also be used for ongoingevaluation of referral laboratories.

Scope

5. The scope of the project should be slightly expanded with comment on economic factors.

! Section 3 has been revised and states that the selection criteria for a referral laboratory fall intothree major related areas: quality of laboratory service, cost effectiveness, and efficiency ofservice. These issues are also addressed in the Foreword.

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6. Add a section for periodic evaluation after the initial selection.

! See response to Comment 2.

7. The scope should be expanded to include directions for creating both a “request for proposal”for reference laboratory services and for evaluating bids received using predetermined criteriaaddressing both quality and pricing of services offered. Quality assurance and adequatesupervisory oversight must be assured for all operating shifts.

! The subcommittee believes these issues are adequately addressed in Section 3 (Criteria forSelection) and Section 3.1 (Quality of Referral Laboratory Service.)

Section 3.0

8. Client sensitivity and a good support system (client services) should be added to the criteria forselection described in Section 3.0.

! The following sentence has been added to Seciton 3.1.2.5: “(See text in that Section).” As aresult of this change, another question has been added to Section VI of the checklist.

9. The laboratory must be accredited/licensed by an appropriate overwatch agency; regarding3.1.2, the referral laboratory must provide documentation attesting to accreditation/licensure.

! In Section 3.1.2.3, External Quality Assessment Activities, a number (5) has been added whichstates: “The referring laboratory must ascertain that the referral laboratory iscertified/accredited/licensed where required and appropriate.” The following footnoteaccompanies this statement: “In the United States, the referral laboratory must be CLIA-88certified for high complexity testing in the specialty/subspecialty where required andappropriate.”

10. Add at the end of the sentence “and at a cost effective level.”

! Section 3 has been revised to read: “...the selection criteria fall into three major related areas:quality of laboratory service, cost effectiveness, and efficiency of service.” The issue of costis also addressed in the Foreword.

11. The Instrument Maintenance section should be deleted from the criteria for selection.

! The subcommittee believes this section is appropriate and does not detract from the document.

12. Frequently, the physician will ask for an unusual test with no defined normal ranges orestablished track record. Addressing these issues may help laboratories deal better with theseproblems.

! The subcommittee considers this beyond the scope of the document. The referral laboratoryshould communicate to the physician that unusual tests may not have established referenceranges.


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Section 3.1.1

13. On-site laboratory evaluation during peak operating hours is strongly recommended for reasonsstated and to determine adequacy of supervision.

! The following sentence has been added to Section 3.1: “On-site laboratory evaluation duringpeak operating hours is recommended and appropriate.”

Section 3.1.2.1

14. Appropriate supervisory oversight on all shifts and adjusted to test volume is very important.

! The subcommittee believes this could be verified during an on-site laboratory evaluation duringpeak operating hours which is mentioned in Section 3.1. Also in Figure 1 (now the Appendix),III, one of the questions inquires: “Does the laboratory have a qualified supervisor during allhours of operation?”

Section 3.1.2.2

15. I feel that not only should test procedures be reviewed but also method developmentprocedures. To do so, I look at a representative sample of method development reports andevaluate their expectations for accuracy, etc., for re-evaluation and for evaluation of the clinicalrelevance of the method (as distinct from the clinical relevance of the analyte as addressed incomment #6 and 3.1.2.2(5).

! The subcommittee considers review of method development procedures beyond the scope ofthe document. (In the United States, review of method development procedures is included inthe requirements for CLIA certification. See response to Comment 9.)

Section 3.1.2.3

16. External quality assurance should apply to all operating shifts, especially evening shifts, withdocumentation.

! The subcommittee agrees with the comment. Review of external quality assur-ance/improvement is included in the requirements for certification/accreditation/licensure. Seeresponse to Comment 9.

Section 3.2.5(3)

17. Communication of panic values must be fully documented including when and to whom theinformation was given.

! The subcommittee believes this issue is beyond the scope of the document. Documentationrequirements are imposed on referral laboratories by licensing and accrediting agencies.

Figure 1 (now the Appendix)

18. VII.D: The following question should be added: Does the laboratory notify you of test delaysor changes as or before they occur?

! The following sentence has been added to Section 3.2.4: “Unanticipated delays in reportingresults should be communicated to the referring laboratory.” Additional revisions concerningcommunications between the referring and the referral laboratory have also been made.

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19. The Referral Laboratory Evaluation Checklist at the end of the document could be developedinto a detailed project management flowchart that includes a set of general procedures andforms codifying the informational contents of the main document. This would assure that allimportant initial and ongoing data are collected, reviewed, and acted on when included in thestructure of the referring laboratory’s quality assurance/improvement and risk managementprogram.

! The subcommittee encourages the users of this document to modify the Referral LaboratoryEvaluation Checklist as necessary to accommodate their needs.

Summary of Comments

20. I agree with the Committee that a section on contract negotiation is outside the scope of theguideline; however, there should be some mention of economic considerations. The “low bid”may not be best for all. Some pricing arrangements may be illegal or even “bean counters arenot always right.”

! Section 3 has been revised to include cost effectiveness and also to emphasize that selectionof a referral laboratory should be based primarily on the quality of services provided. The issueof cost is also addressed in the Foreword.


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

readers should refer to the most recent editions.

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Related NCCLS Publications*

GP2-A3 Clinical Laboratory Technical Procedure Manuals—Third Edition; Approved Guideline (1996).Guidelines that address design, preparation, maintenance, and use of technical proceduremanuals in the clinical laboratory.

H5-A3 Procedures for the Handling and Transport of Diagnostic Specimens and Etiologic Agents—Third Edition; Approved Standard (1994). Gives proper packaging, handling, and transportrequirements for medical specimens and governing regulations.

H18-A Procedures for the Handling and Processing of Blood Specimens; Approved Guideline (1990).Addresses the multiple factors associated with the handling and processing of bloodspecimens, factors which can introduce test result imprecision or systematic bias.

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