X3-R Vol. 22 No.

4
Implementing a Needlestick and Sharps Injury Prevention Program in
the Clinical Laboratory; A Report

This document provides guidance for implementing safer medical devices that reduce or
eliminate sharps injuries to laboratory personnel.

An NCCLS report for national application.

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

Most NCCLS documents are subject to two levels of VOLUNTEER PARTICIPATION

consensus—“proposed” and “approved.” Depending on Healthcare professionals in all specialties are urged to
volunteer for participation in NCCLS projects. Please
contact the NCCLS Executive Offices for additional
information on committee participation.
Volume 22 X3-R

Implementing a Needlestick and Sharps Injury Prevention Program in

the Clinical Laboratory; A Report
Abstract

NCCLS document X3-R—Implementing a Needlestick and Sharps Injury Prevention Program in

the Clinical Laboratory; A Report was written for use by laboratory managers and is intended to
provide a systematic approach for implementing the requirements of the Revised OSHA
Bloodborne Pathogen Standard, a U.S. federal regulation. Written in an expanded checklist
format, it outlines the important steps laboratory professionals must take in identifying devices
that have the potential for causing injury, selecting safer medical devices for evaluation,
evaluating the selected devices, adopting the new device for routine use, and implementing a
continuous quality improvement process. While this document will serve as a useful resource for
a wider audience, it is based on U.S. regulations, and is intended for use primarily in the United
States.

NCCLS. Implementing a Needlestick and Sharps Injury Prevention Program in the Clinical
Laboratory; A Report. NCCLS document X3-R (ISBN 1-56238-460-0). NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.

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

i
Number 4 NCCLS

ii
 X3-R
ISBN 1-56238-460-0
ISSN 0273-3099
Implementing a Needlestick and Sharps Injury Prevention Program in
the Clinical Laboratory; A Report

Volume 22 Number 4

M. Clare Edelmayer, M.T.(ASCP), R.N., M.S.

Beverly Kovanda, Ph.D.
Donna M. Meyer, Ph.D.
David Sewell, Ph.D.
Number 4 NCCLS

This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval

system, transmitted, or made available in any form or by any means (electronic, mechanical,
photocopying, recording, or otherwise) without prior written permission from NCCLS, except as
stated below.

NCCLS hereby grants permission to reproduce limited portions of this publication for use in
laboratory procedure manuals at a single site, for interlibrary loan, or for use in educational
programs provided that multiple copies of such reproduction shall include the following notice,
be distributed without charge, and, in no event, contain more than 20% of the document’s text.

Reproduced with permission, from NCCLS publication X3-R—Implementing a

Needlestick and Sharps Injury Prevention Program in the Clinical Laboratory; A
Report (ISBN 1-56238-460-0). Copies of the current edition may be obtained
from NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-
1898, USA.

Permission to reproduce or otherwise use the text of this document to an extent that exceeds the
exemptions granted here or under the Copyright Law must be obtained from NCCLS by written
request. To request such permission, address inquiries to the Executive Director, NCCLS, 940
West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA.

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

Suggested Citation

(NCCLS. Implementing a Needlestick and Sharps Injury Prevention Program in the Clinical
Laboratory; A Report. NCCLS document X3-R [ISBN 1-56238-460-0]. NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002.)

Report

Approved by Board of Directors

January 2002

Published
March 2002

ISBN 1-56238-460-0
ISSN 0273-3099
iv
Volume 22 X3-R

Committee Membership

Needlestick Prevention Working Group

Geraldine L. Barnes, M.T.(ASCP), M.S. NCCLS

Project Group Leader Wayne, Pennsylvania

M. Clare Edelmayer, M.T.(ASCP), R.N., M.S. Doylestown Hospital

Doylestown, Pennsylvania

Beverly Kovanda, Ph.D. Columbus State Community College

Westerville, Ohio

Donna M. Meyer, Ph.D. CHRISTUS Health

Houston, Texas

David Sewell, Ph.D. Veterans Affairs Medical Center

Portland, Oregon

Patrice E. Polgar NCCLS

Editor Wayne, Pennsylvania

Donna M. Wilhelm NCCLS

Assistant Editor Wayne, Pennsylvania

Acknowledgements

NCCLS would like to acknowledge the participation of the following persons in the review of
Implementing a Needlestick and Sharps Injury Prevention Program in the Clinical Laboratory:

Linda A. Chiarello, R.N., M.S. Centers for Disease Control and Prevention
Janice Huy, R.D., M.S., L.D. Centers for Disease Control and Prevention
Louann Lawrence, Ph.D. Louisiana State University Health Sciences Center
Gina Pugliese, R.N., M.S. Premier Safety Institute
Lorraine Tyndall BD

v
Number 4 NCCLS

vi
Volume 22 X3-R

Active Membership
(as of 1 January 2002)

Sustaining Members Clinical Laboratory Management Department of Veterans Affairs

Association Deutsches Institut für Normung
Abbott Laboratories COLA (DIN)
American Association for College of American Pathologists FDA Center for Devices and
Clinical Chemistry College of Medical Laboratory Radiological Health
Bayer Corporation Technologists of Ontario FDA Center for Veterinary
Beckman Coulter, Inc. College of Physicians and Medicine
BD and Company Surgeons of Saskatchewan FDA Division of Anti-Infective
bioMérieux, Inc. Fundación Bioquímica Argentina Drug Products
CLMA International Association of Medical Health Care Financing
College of American Pathologists Laboratory Technologists Administration/CLIA Program
GlaxoSmithKline International Council for Health Care Financing
Nippon Becton Dickinson Co., Ltd. Standardization in Haematology Administration
Ortho-Clinical Diagnostics, Inc. International Federation of Iowa State Hygienic Laboratory
Pfizer Inc Clinical Chemistry Massachusetts Department of
Roche Diagnostics, Inc. Italian Society of Clinical Public Health Laboratories
Biochemistry National Association of Testing
Professional Members Japan Society of Clinical Chemistry Authorities – Australia
Japanese Committee for Clinical National Center of Infectious
AISAR-Associazione Italiana per lo Laboratory Standards and Parasitic Diseases (Bulgaria)
Studio degli Joint Commission on Accreditation National Institute of Standards
American Academy of Family of Healthcare Organizations and Technology
Physicians National Academy of Clinical Ohio Department of Health
American Association for Biochemistry Ontario Ministry of Health
Clinical Chemistry National Society for Saskatchewan Health-Provincial
American Association for Histotechnology, Inc. Laboratory
Respiratory Care Ontario Medical Association Scientific Institute of Public Health;
American Chemical Society Quality Management Program- Belgium Ministry of Social
American Medical Technologists Laboratory Service Affairs, Public Health and the
American Public Health Association RCPA Quality Assurance Programs Environment
American Society for Clinical PTY Limited South African Institute for Medical
Laboratory Science Sociedade Brasileira de Analises Research
American Society of Hematology Clinicas Swedish Institute for Infectious
American Society for Microbiology Sociedade Brasileira de Disease Control
American Type Culture Patologia Clinica Thailand Department of Medical
Collection, Inc. Sociedad Espanola de Bioquimica Sciences
Asociacion de Laboratorios de Alta Clinica y Patologia Molecular
Complejidad Turkish Society of Microbiology Industry Members
Asociación Española Primera de
Socorros (Uruguay) Government Members AB Biodisk
Asociacion Mexicana de Abbott Laboratories
Bioquimica Clinica A.C. Association of Public Health Abbott Laboratories, MediSense
Assn. of Public Health Laboratories Laboratories Products
Assoc. Micro. Clinici Italiani- Armed Forces Institute of Pathology Accumetrics, Inc.
A.M.C.L.I. BC Centre for Disease Control Agilent Technologies, Inc.
Australasian Association of Centers for Disease Control and Ammirati Regulatory Consulting
Clinical Biochemists Prevention Anaerobe Systems
British Society for Antimicrobial Centers for Medicare & Medicaid Asséssor
Chemotherapy Services/CLIA Program AstraZeneca
CADIME-Camara De Instituciones Centers for Medicare & Medicaid Aventis
De Diagnostico Medico Services Avocet Medical, Inc.
Canadian Society for Medical Chinese Committee for Clinical Axis-Shield POC AS
Laboratory Science—Société Laboratory Standards Bayer Corporation – Elkhart, IN
Canadienne de Science de Commonwealth of Pennsylvania Bayer Corporation – Tarrytown, NY
Laboratoire Médical Bureau of Laboratories
vii
Number 4 NCCLS

Bayer Corporation – West Haven, Immunicon Corporation The Clinical Microbiology Institute
CT I-STAT Corporation The Toledo Hospital (OH)
Bayer Medical Ltd. International Technidyne Trek Diagnostic Systems, Inc.
BD Corporation Versicor, Inc.
BD Biosciences – San Jose, CA IntraBiotics Pharmaceuticals, Inc. Vetoquinol S.A.
BD Consumer Products Kendall Sherwood-Davis & Geck Visible Genetics, Inc.
BD Diagnostic Systems LAB-Interlink, Inc. Vysis, Inc.
BD Italia S.P.A. Labtest Diagnostica S.A. Wallac Oy
BD VACUTAINER Systems LifeScan, Inc. (a Johnson & Wyeth-Ayerst
Beckman Coulter, Inc. Johnson Company) Xyletech Systems, Inc.
Beckman Coulter, Inc. Primary Care Lilly Research Laboratories YD Consultant
Diagnostics Macemon Consultants YD Diagnostics (Seoul, Korea)
Beckman Coulter K.K. (Japan) Medical Device Consultants, Inc.
Bio-Development SRL Merck & Company, Inc. Trade Associations
Bio-Inova Life Sciences Molecular Diagnostics, Inc.
International mvi Sciences (MA) AdvaMed
Bio-Inova Life Sciences North Nabi Association of Medical
America Nichols Institute Diagnostics Diagnostic Manufacturers
BioMedia Laboratories Sdn Bhd (Div. of Quest Diagnostics, Inc.) Japan Association Clinical
bioMérieux (NC) Nissui Pharmaceutical Co., Ltd. Reagents Ind. (Tokyo, Japan)
bioMérieux, Inc. (MO) Nippon Becton Dickinson Co., Ltd. Medical Industry Association
Biometrology Consultants Norfolk Associates, Inc. of Australia
Bio-Rad Laboratories, Inc. Novartis Pharmaceuticals
Bio-Rad Laboratories, Inc. - France Corporation Associate Active Members
Biotest AG Ortho-Clinical Diagnostics, Inc.
Bristol-Myers Squibb Company (Raritan, NJ) 20th Medical Group (SC)
Canadian External Quality Ortho-Clinical Diagnostics, Inc. 31st Medical Group/SGSL (APO,
Assessment Laboratory (Rochester, NY) AE)
Capital Management Consulting, Oxoid Inc. 67th CSH Wuerzburg, GE (NY)
Inc. Paratek Pharmaceuticals 121st General Hospital (CA)
Carl Schaper Pfizer Inc Academisch Ziekenhuis-VUB
Checkpoint Development Inc. Pharmacia Corporation (Belgium)
Chronolab Ag Powers Consulting Services Acadiana Medical Laboratories,
Clinical Design Group Inc. Premier Inc. LTD (LA)
Clinical Laboratory Improvement Procter & Gamble Adena Regional Medical Center
Consultants Pharmaceuticals, Inc. (OH)
Cognigen The Product Development Group The Aga Khan Hospital & Medical
Community Medical Center (NJ) Quintiles, Inc. College, Karachi (Pakistan)
Control Lab (Brazil) Radiometer America, Inc. Akershus Central Hospital and AFA
Copan Diagnostics Inc. Radiometer Medical A/S (Norway)
Cosmetic Ingredient Review David G. Rhoads Associates, Inc. Albemarle Hospital (NC)
Cubist Pharmaceuticals Roche Diagnostics GmbH Allegheny General Hospital (PA)
Dade Behring Inc. - Deerfield, IL Roche Diagnostics, Inc. Allegheny University of the
Dade Behring Inc. - Glasgow, DE Roche Laboratories (Div. Health Sciences (PA)
Dade Behring Inc. - Marburg, Hoffmann-La Roche Inc.) Allina Laboratories (MN)
Germany The R.W. Johnson Alton Ochsner Medical
Dade Behring Inc. - Sacramento, CA Pharmaceutical Research Institute Foundation (LA)
Dade Behring Inc. - San Jose, CA Sarstedt, Inc. American Medical Laboratories
Diagnostic Products Corporation SARL Laboratoire Carron (France) (VA)
Eiken Chemical Company, Ltd. Schering Corporation Arkansas Department of Health
Enterprise Analysis Corporation Schleicher & Schuell, Inc. ARUP at University Hospital (UT)
EXPERTech Associates, Inc. Second Opinion Armed Forces Research Institute of
Fort Dodge Animal Health Showa Yakuhin Kako Company, Medical Science (APO, AP)
General Hospital Vienna (Austria) Ltd. Associated Regional &
Gen-Probe Streck Laboratories, Inc. University Pathologists (UT)
GlaxoSmithKline SurroMed, Inc. Aurora Consolidated
Greiner Bio-One Inc. Sysmex Corporation (Japan) Laboratories (WI)
Helena Laboratories Sysmex Corporation Azienda Ospedale Di Lecco (Italy)
Home Diagnostics, Inc. (Long Grove, IL) Bay Medical Center (MI)
viii
Volume 22 X3-R

Baystate Medical Center (MA) Duke University Medical Center Hospital Israelita Albert Einstein
Bbaguas Duzen Laboratories (NC) (Brazil)
(Turkey) Durham Regional Hospital (NC) Hospital Sousa Martins (Portugal)
Bo Ali Hospital (Iran) Dynacare Laboratories - Eastern Hotel Dieu Hospital (Windsor, ON,
Bonnyville Health Center (Alberta, Region (Ottawa, ON, Canada) Canada)
Canada) Dynacare Memorial Hermann Houston Medical Center (GA)
British Columbia Cancer Agency Laboratory Services (TX) Huddinge University Hospital
(Vancouver, BC, Canada) E.A. Conway Medical Center (LA) (Sweden)
Broward General Medical Center Eastern Maine Medical Center Hurley Medical Center (MI)
(FL) East Side Clinical Laboratory (RI) Indiana State Board of Health
Calgary Laboratory Services Elyria Memorial Hospital (OH) Indiana University
Carilion Consolidated Laboratory Emory University Hospital (GA) Institute of Medical and Veterinary
(VA) Esoterix Center for Infectious Science (Australia)
Cathay General Hospital (Taiwan) Disease (TX) Instituto Scientifico HS. Raffaele
CB Healthcare Complex Fairfax Hospital (VA) (Italy)
(Sydney, NS, Canada) Fairview-University Medical International Health Management
Central Peninsula General Hospital Center (MN) Associates, Inc. (IL)
(AK) Florida Hospital East Orlando Jackson Memorial Hospital (FL)
Central Texas Veterans Health Care Foothills Hospital (Calgary, AB, Jersey Shore Medical Center (NJ)
System Canada) John F. Kennedy Medical Center
Centre Hospitalier Regional del la Fort St. John General Hospital (NJ)
Citadelle (Belgium) (Fort St. John, BC, Canada) John Peter Smith Hospital (TX)
Centro Diagnostico Italiano Fox Chase Cancer Center (PA) Kadlec Medical Center (WA)
(Milano, Italy) Franklin Square Hospital Center Kaiser Permanente Medical Care
Champlain Valley Physicians (MD) (CA)
Hospital (NY) Fresenius Medical Care/Spectra Kaiser Permanente (MD)
Chang Gung Memorial Hospital East (NJ) Kantonsspital (Switzerland)
(Taiwan) Fresno Community Hospital and Kenora-Rainy River Regional
Children’s Hospital (NE) Medical Center Laboratory Program (Ontario,
Children’s Hospital & Clinics (MN) Frye Regional Medical Center (NC) Canada)
Children’s Hospital King's Gambro Healthcare Laboratory Kern Medical Center (CA)
Daughters (VA) Services (FL) Kimball Medical Center (NJ)
Children’s Hospital Medical Center Gateway Medical Center (TN) King Faisal Specialist Hospital
(Akron, OH) GDS Technology, Inc (IN) (Saudi Arabia)
Children’s Hospital of Geisinger Medical Center (PA) King Khalid National Guard Hospital
Philadelphia (PA) Grady Memorial Hospital (GA) (Saudi Arabia)
Clarian Health–Methodist Hospital Guthrie Clinic Laboratories (PA) King’s Daughter Medical Center
(IN) Hahnemann University Hospital (KY)
Clendo Lab (Puerto Rico) (PA) Klinični Center (Slovenia)
Clinical Laboratory Partners, LLC Harris Methodist Erath County LabCorp (NC)
(CT) (TX) Laboratories at Bonfils (CO)
CLSI Laboratories (PA) Harris Methodist Fort Worth (TX) Laboratoire de Santé Publique du
Commonwealth of Kentucky Hartford Hospital (CT) Quebec (Canada)
Community Hospital of Lancaster Headwaters Health Authority Laboratório Fleury S/C Ltda.
(PA) (Alberta, Canada) (Brazil)
CompuNet Clinical Laboratories Health Network Lab (PA) Laboratory Corporation of America
(OH) Health Partners Laboratories (VA) (NJ)
Covance Central Laboratory Heartland Health System (MO) Laboratory Corporation of
Services (IN) Highlands Regional Medical Center America (MO)
Danville Regional Medical Center (FL) LAC and USC Healthcare
(VA) Hoag Memorial Hospital Network (CA)
Delaware Public Health Laboratory Presbyterian (CA) Lakeland Regional Medical Center
Department of Health & Community Holmes Regional Medical Center (FL)
Services (New Brunswick, Canada) (FL) Lancaster General Hospital (PA)
DesPeres Hospital (MO) Holy Spirit Hospital (PA) Langley Air Force Base (VA)
DeTar Hospital (TX) Holzer Medical Center (OH) LeBonheur Children’s
Detroit Health Department (MI) Hospital for Sick Children Medical Center (TN)
Doctors Hospital (Bahamas) (Toronto, ON, Canada) Lewis-Gale Medical Center (VA)

ix
Number 4 NCCLS

Libero Instituto Univ. Campus North Kansas City Hospital (MO) St-Eustache Hospital (Quebec,
BioMedico (Italy) North Mississippi Medical Center Canada)
Long Beach Memorial Medical North Shore – Long Island Jewish St. John Hospital and Medical
Center (CA) Health System Laboratories (NY) Center (MI)
Louisiana State University Northridge Hospital Medical St. John Regional Hospital (St.
Medical Center Center (CA) John, NB, Canada)
Maccabi Medical Care and Health Northwestern Memorial Hospital St. Joseph Hospital (NE)
Fund (Israel) (IL) St. Joseph’s Hospital – Marshfield
Magee Womens Hospital (PA) O.L. Vrouwziekenhuis (Belgium) Clinic (WI)
Manitoba Health (Winnipeg, Ordre professionnel des St. Joseph’s Medical Center (CA)
Canada) technologists médicaux du St. Luke’s Regional Medical
Martin Luther King/Drew Medical Québec Center (IA)
Center (CA) Ospedali Riuniti (Italy) St. Mark’s Hospital (UT)
Massachusetts General Hospital The Ottawa Hospital St. Mary Medical Center (IN)
(Microbiology Laboratory) (Ottawa, ON, Canada) St. Mary of the Plains Hospital
MDS Metro Laboratory Services Our Lady of Lourdes Hospital (NJ) (TX)
(Burnaby, BC, Canada) Our Lady of the Resurrection St. Mary’s Hospital & Medical
Medical College of Virginia Medical Center (IL) Center (CO)
Hospital Pathology and Cytology St. Paul’s Hospital (Vancouver, BC,
Medicare/Medicaid Certification, Laboratories, Inc. (KY) Montreal)
State of North Carolina The Permanente Medical Group St. Vincent Medical Center (CA)
Memorial Medical Center (IL) (CA) Ste. Justine Hospital (Montreal, PQ,
Memorial Medical Center (LA) Piedmont Hospital (GA) Canada)
Jefferson Davis Hwy Pocono Hospital (PA) Salina Regional Health Center (KS)
Memorial Medical Center (LA) Presbyterian Hospital of Dallas San Francisco General Hospital
Napoleon Avenue (TX) (CA)
Mescalero Indian Hospital (NM) Prodia Clinical Laboratory C Santa Cabrini Hospital
Methodist Hospitals of Memphis (Indonesia) (Montreal, PQ Canada)
(TN) Providence Health System (OR) Santa Clara Valley Medical Center
MetroHealth Medical Center (OH) Providence Seattle Medical Center (CA)
Michigan Department of (WA) Seoul Nat’l University Hospital
Community Health Queen Elizabeth Hospital (Prince (Korea)
Mississippi Baptist Medical Center Edward Island, Canada) Shanghai Center for the
Monmouth Medical Center (NJ) Queensland Health Pathology Clinical Laboratory (China)
Monte Tabor – Centro Italo - Services (Australia) South Bend Medical Foundation
Brazileiro de Promocao (Brazil) Quest Diagnostics Incorporated (IN)
Montreal Children’s Hospital (CA) Southern California Permanente
(Canada) Quintiles Laboratories, Ltd. (GA) Medical Group
Montreal General Hospital Reading Hospital and Medical South Western Area Pathology
(Canada) Center (PA) Service (Australia)
MRL Pharmaceutical Services, Inc. Regions Hospital Specialty Laboratories, Inc. (CA)
(VA) Reid Hospital & Health Care Stanford Hospital and Clinics (CA)
MRL Reference Laboratory (CA) Services (IN) State of Washington Department of
National Institutes of Health (MD) Research Medical Center (MO) Health
Naval Surface Warfare Center (IN) Rex Healthcare (NC) Stormont-Vail Regional Medical
Nebraska Health System Rhode Island Department of Health Center (KS)
New Britain General Hospital (CT) Laboratories Sun Health-Boswell Hospital (AZ)
New England Fertility Institute (CT) Riyadh Armed Forces Hospital Sunrise Hospital and Medical
New England Medical Center (Saudi Arabia) Center (NV)
Hospital (MA) Royal Columbian Hospital (New T.A. Sourasky Medical Center
New York Hospital Medical Center Westminster, BC, Canada) (Israel)
of Queens Sacred Heart Hospital (MD) Tampa General Hospital (FL)
New York State Department of Saint Mary’s Regional Medical Temple University Hospital (PA)
Health Center (NV) Tenet Odessa Regional Hospital (TX)
North Carolina State Laboratory of St. Alexius Medical Center (ND) The Toledo Hospital (OH)
Public Health St. Anthony Hospital (CO) Touro Infirmary (LA)
Northern Indiana Education St. Barnabas Medical Center (NJ) Trident Regional Medical Center
Foundation (SC)
Tripler Army Medical Center (HI)
x
Volume 22 X3-R

Truman Medical Center (MO) University of Texas M.D. Anderson Washoe Medical Center
UCSF Medical Center (CA) Cancer Center Laboratory (NV)
UNC Hospitals (NC) University of Virginia Medical West Jefferson Medical Center
University Hospital (Gent) Center (LA)
(Belgium) University of Washington Wilford Hall Medical Center (TX)
University Hospitals of Cleveland UZ-KUL Medical Center (Belgium) William Beaumont Hospital (MI)
(OH) VA (Denver) Medical Center (CO) Williamsburg Community Hospital
The University Hospitals (OK) VA (Kansas City) Medical Center (VA)
University of Alabama-Birmingham (MO) Winn Army Community Hospital
Hospital VA (San Diego) Medical Center (GA)
University of Alberta Hospitals (CA) Winnipeg Regional Health
(Canada) VA (Tuskegee) Medical Center Authority (Winnipeg, Canada)
University of Colorado Health (AL) Wishard Memorial Hospital (IN)
Science Center VA Outpatient Clinic (OH) Yonsei University College of
University of Chicago Hospitals Vejle Hospital (Denmark) Medicine (Korea)
(IL) Washington Adventist Hospital York Hospital (PA)
University of Illinois at Chicago (MD)
University of the Ryukyus (Japan)

OFFICERS BOARD OF DIRECTORS

F. Alan Andersen, Ph.D., Susan Blonshine, RRT, RPFT, Tadashi Kawai, M.D., Ph.D.
President FAARC International Clinical Pathology
Cosmetic Ingredient Review TechEd Center

Donna M. Meyer, Ph.D., Wayne Brinster J. Stephen Kroger, M.D., FACP

President Elect BD COLA
CHRISTUS Health
Kurt H. Davis, FCSMLS, CAE Gary L. Myers, Ph.D.
Emil Voelkert, Ph.D. Canadian Society for Medical Centers for Disease Control and
Secretary Laboratory Science Prevention
Roche Diagnostics GmbH
Robert L. Habig, Ph.D. Barbara G. Painter, Ph.D.
Gerald A. Hoeltge, M.D. Ampersand Medical Bayer Corporation
Treasurer
The Cleveland Clinic Foundation Thomas L. Hearn, Ph.D. Ann M. Willey, Ph.D., J.D.
Centers for Disease Control and New York State Department of
William F. Koch, Ph.D., Prevention Health
Immediate Past President
National Institute of Standards Carolyn D. Jones, J.D., M.P.H. Judith A. Yost, M.A., M.T.(ASCP)
and Technology AdvaMed Centers for Medicare & Medicaid
Services
John V. Bergen, Ph.D.,
Executive Director

xi
Number 4 NCCLS

xii
Volume 22 X3-R

Contents

Abstract ...................................................................................................................................... i
Committee Membership............................................................................................................ v
Active Membership ................................................................................................................. vii
Foreword ................................................................................................................................. xv
I. Introduction ................................................................................................................... 1

II. Scope ........................................................................................................................... 1

III. Glossary......................................................................................................................... 2

IV. Updating the Exposure Control Plan............................................................................. 3

V. Implementing a Sharps Injury Prevention Program...................................................... 5

A. Establish a Multidisciplinary Team...................................................................... 5

B. Perform an Internal Review ................................................................................. 7

C. Select Devices for Evaluation .............................................................................. 8

D. Evaluating Selected Devices ................................................................................ 9

E. Adopt the New Device for Routine Use............................................................. 12

F. Implementing a Continuous Quality Improvement Process .............................. 13

Bibliography............................................................................................................................ 14
NCCLS Resources................................................................................................................... 15
Useful Websites....................................................................................................................... 16

xiii
Number 4 NCCLS

xiv
Volume 22 X3-R

Foreword

This document, developed as a report, was initiated in direct response to a need expressed by
NCCLS constituencies. As defined in the Administrative Procedures, a report is a document that
does not undergo consensus review and is published upon approval by the Board of Directors. It
allows for an expedited review, with the purpose of getting the needed information out as quickly
as possible, while not sacrificing quality or important review. Because healthcare institutions are
required to implement the provisions of the Revised OSHA Bloodborne Pathogen Standard in a
short period of time, an expedited process was desirable.

Implementing a sharps prevention program is the responsibility of the institution whose workers
may be at risk for exposure to blood or other potentially infectious materials. But it is clear that
the laboratory has specific needs relative to identifying, evaluating, and adopting safer medical
devices. The working group’s goal was to outline a process that goes beyond general
recommendations for the healthcare institution and specifically addresses the needs of the
professionals performing specimen collection and clinical laboratory procedures.

Use this report as a checklist, checking off each box as you have addressed the issue.

The working group welcomes comments on the utility of Implementing a Needlestick and Sharps
Injury Prevention Program in the Clinical Laboratory.

Standard Precautions

Because it is often impossible to know what might be infectious, all human blood specimens are
to be treated as infectious and handled according to “standard precautions.” Standard precautions
are new guidelines that combine the major features of “universal precautions and body substance
isolation” practices. Standard precautions cover the transmission of any pathogen and thus are
more comprehensive than universal precautions which are intended to apply only to transmission
of bloodborne pathogens. Standard precaution and universal precaution guidelines are available
from the U.S. Centers for Disease Control and Prevention (Guideline for Isolation Precautions in
Hospitals. Infection Control and Hospital Epidemiology. CDC. 1996;Vol 17;1:53-80), (MMWR
1987;36[suppl 2S]2S-18S), and (MMWR 1988;37:377-382, 387-388). For specific precautions
for preventing the laboratory transmission of blood-borne infection from laboratory instruments
and materials and for recommendations for the management of blood-borne exposure, refer to
the most current edition of NCCLS document M29—Protection of Laboratory Workers from
Occupationally Acquired Infections.

Key Words

Evaluation, needlestick, safer medical devices, sharps

xv
Number 4 NCCLS

xvi
 Volume 22 X3-R

I. Introduction

In 1991, the Occupational Safety and Health Administration (OSHA) published the
Bloodborne Pathogens Standard (29 CFR 1930.1030) to reduce the health risk to workers
whose duties involve exposure to blood or other potentially infectious materials. The
provisions of the standard were based on OSHA’s determination that a combination of
engineering and work practice controls, personal protective equipment, training medical
surveillance, hepatitis B vaccination, signs and labels, and other requirements would
minimize the risk of disease transmission. To address the provisions of the standard, each
institution was required to develop and implement an Exposure Control Plan. Such plans
have guided compliant institutions for the last ten years.

Since the publication of the standard, a wide variety of medical devices have been developed
to reduce the risk of needlesticks and other sharps injuries. In late 2000, Congress passed the
Federal Needlestick Safety and Prevention Act (Public Law 104-439) that authorized OSHA
to revise the Bloodborne Pathogens Standard to strengthen the identification, evaluation,
documentation, and use of safety engineered sharp devices. (Luebbert,
advance/LABORATORY, March 2001) Healthcare facilities whose workers are subject to
potential exposure to bloodborne pathogens are covered under the Bloodborne Pathogen
Standard and subject to this final rule. There are several requirements outlined in the rule,
including:

• Modifying definitions related to engineering controls;

• Updating the Exposure Control Plan to include specified requirements;

• Soliciting employee input for the purpose of identifying safer medical devices and
evaluating their effectiveness; and

• Maintaining a detailed log and database of exposures to bloodborne pathogens related to

needlestick and other sharps injuries.

The intent of the Revised OSHA Bloodborne Pathogen Standard is to minimize the risk of
exposure to bloodborne pathogens by implementing safer medical devices that reduce or
eliminate sharps injuries to healthcare workers.

This guide will aid institutions in implementing the requirements and analyzing and
improving practices, with the goal of providing a safer work environment. The clinical
laboratory plays an important role in a sharps injury prevention program. Though
some steps may be the responsibility of the institution, it is vital that the clinical
laboratory actively participates and leads the organization in implementing the steps
relative to assessing the clinical laboratory’s devices and procedures.

II. Scope

This guide provides direction for implementing the requirements of the Revised OSHA
Bloodborne Pathogen Standard. It is limited to devices related to specimen collection
and clinical laboratory testing. It will provide guidance for medical centers and
hospitals, as well as for reference and physician office laboratories.
An NCCLS national report. ©NCCLS. All rights reserved. 1
 Number 4 NCCLS

While it is well understood that sharps such as needles are responsible for many injuries, it is
very important to understand that, in the clinical laboratory, there are other devices that have
the potential of causing injury. Though not an inclusive list, devices that have the potential
for causing injury include:

- phlebotomy needles
- syringe needles used in the laboratory and used for drawing blood
- winged blood collection sets
- glass capillary tubes
- glass blood collection tubes
- glass test tubes
- glass pipettes
- glass slides
- instrument probes
- scalpels used in the laboratory
- lancets
- microtome blades.

III. Glossary a

Active safety device, n - A device requiring a user to take action to actively engage the
safety feature to ensure its proper function.

Bloodborne pathogens, n - Pathogenic microorganisms that are present in human blood and
can cause disease in humans; NOTE: These pathogens include, but are not limited to,
hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus
(HIV).

Contaminated, adj - The presence or the reasonably anticipated presence of blood or other
potentially infectious materials on an item or surface.

Contaminated sharps, n - Any contaminated object that can penetrate the skin including,
but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends
of dental wires.

Engineering controls, n - Controls that isolate, minimize, or remove the bloodborne

pathogens hazard from the workplace; NOTE: That is, safer medical devices, such as sharps
with engineered sharps injury protection and needleless systems as well as other medical
devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens.
Examples include blunt suture needles and plastic or mylar-wrapped glass capillary tubes, as
well as controls that are not medical devices, such as sharps disposal containers and biosafety
cabinets.

a
Some of these definitions are found in NCCLS document NRSCL8—Terminology and Definitions for Use in
NCCLS Documents. For complete definitions and detailed source information, please refer to the most current
edition of that document.

2 An NCCLS national report. ©NCCLS. All rights reserved.

 Volume 22 X3-R

Exposure control plan (ECP), n - A written plan required by OSHA that identifies those
tasks and procedures in which occupational exposure may occur and that identifies the
positions whose duties include those tasks and procedures identified as having occupational
exposure; NOTE: The ECP requires the employer to identify the individuals who will
receive the training, protective equipment, vaccination, and other protections of the standard.
The plan must be reviewed and updated at least annually.

Exposure incident, n - A specific eye, mouth, other mucous membrane, nonintact skin, or
parenteral contact with blood or other potentially infectious materials that results from the
performance of an employee's duties.

Laboratory, n - A facility for the biological, microbiological, serological, chemical,

immunohematological, hematological, biophysical, cytological, pathological, or other
examination of materials derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings. These examinations also include procedures
to determine, measure, or otherwise describe the presence or absence of various substances
or organisms in the body.

Needleless system, n - A device that does not use needles for: i) The collection of bodily
fluids or withdrawal of body fluids after initial venous or arterial access is established; ii) the
administration of medication or fluids; or iii) any other procedure involving the potential for
occupational exposure to bloodborne pathogens due to percutaneous injuries from
contaminated sharps.

Occupational exposure, n - Reasonably anticipated skin, eye, mucous membrane, or

parenteral contact with blood or other potentially infectious materials that may result from
the performance of an employee's duties. NOTE: “Reasonably anticipated” includes the
potential for accidental exposure.

Passive safety device, n - A device that incorporates a safety mechanism that does not rely
on the worker to activate it and is in effect throughout the use of the device.

Sharps with engineered sharps injury protection, n - A nonneedle sharp or a needle

device used for withdrawing body fluids, accessing a vein or artery, or administering
medications or other fluids, with a built-in safety feature or mechanism that effectively
reduces the risk of an exposure incident.

Work practice controls, n - Controls that reduce the likelihood of exposure by altering the
manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed
technique).

IV. Updating the Exposure Control Plan

Since 1991, every institution whose workers are subject to potential exposure to bloodborne
pathogens is required to have an Exposure Control Plan. (For more information regarding
this Exposure Control Plan, see the Compliance Directive for the Bloodborne Pathogens
Standard (29 CFR 1930.1030). While the responsibility for updating the plan may rest
with someone outside of the clinical laboratory (e.g., institutional safety officer), it is
An NCCLS national report. ©NCCLS. All rights reserved. 3
Number 4 NCCLS

important to understand the requirements relative to the plan and how it impacts on
establishing a sharps injury prevention program in the laboratory.

To meet the requirements of the Needlestick and Other Sharps Injuries; Final Rule, the
Exposure Control Plan must incorporate the following revisions (check them off as you
complete them):

Two new definitions:

• Needleless System: a device that does not use needles for: (a) the collection of bodily
fluids or withdrawal of body fluids after initial venous or arterial access is
established; (b) the administration of medication or fluids; or (c) any other procedure
involving the potential for occupational exposure to bloodborne pathogens due to
percutaneous injuries from contaminated sharps.

• Sharps with Engineered Sharps Injury Protections: a nonneedle sharp or a needle

device used for withdrawing body fluids, accessing a vein or artery, or administering
medications or other fluids, with a built-in safety feature or mechanism that
effectively reduces the risk of an exposure incident.

An expanded definition for:

• Engineering Controls: Controls that isolate or remove the bloodborne pathogens

hazard from the workplace (i.e., safer medical devices, such as sharps with
engineered sharps injury protections and needleless systems as well as other medical
devices designed to reduce the risk of percutaneous exposure to bloodborne
pathogens. Examples include blunt suture needles and plastic or mylar-wrapped
glass capillary tubes, as well as controls that are not medical devices, such as sharps
disposal containers and biosafety cabinets.)

Identification of the ways in which employers implement new requirements that reflect
changes in technology to eliminate or reduce exposure to bloodborne pathogens.

A process for soliciting input from nonmanagerial employees (who potentially are
exposed to injuries from contaminated sharps) responsible for direct patient care in the
identification, evaluation, and selection of effective engineering and work practice
controls, as well as a process for documenting this input.

Employee input can include:

• involvement in informal problem-solving groups;

• participation in safety audits, worksite inspections, or exposure incident

investigations;

• participation in analysis of exposure incident data or in job or process hazard

analysis;

• participation in the evaluation of devices through pilot testing; and

4 An NCCLS national report. ©NCCLS. All rights reserved.
 Volume 22 X3-R

• involvement in a safety and health committee properly constituted and operated in

conformance with the National Labor Relations Act.

Documentation of ongoing consideration and implementation of appropriate

commercially available and effective safer medical devices designed to eliminate or
minimize occupational exposure by:

• describing safer devices identified as candidates for adoption;

• the method or methods used to evaluate devices and the results of evaluation; and

• justification for selection decisions.

Establishment and maintenance of a sharps injury log for recording percutaneous injuries
from contaminated sharps.* The information recorded must protect the confidentiality of
the injured employee and contain, at a minimum:

• type and brand of device involved in the incident;

• department or work area where the exposure incident occurred; and

• explanation of how the exposure incident occurred.

*The Exposure Prevention Information Network (EPINet) was developed by Janine Jagger, M.P.H., Ph.D., and
colleagues to provide standardized methods for recording percutaneous injuries and blood and body fluid
contacts, in order to assist hospitals in complying with the OSHA recordkeeping requirements of the 2001
revised Bloodborne Pathogens Standard. Hospitals can use the EPINet system to compare and share
information and identify successful prevention measures. The EPINet system includes a Uniform Needlestick
and Sharp Object Injury Report and a Uniform Blood and Body Fluid Exposure Report, as well as software for
entering, accessing, and analyzing the data from the forms. EPINet provides specific identification of the
devices and products associated with exposures and the mechanisms by which the exposures occurred. This
information allows hospitals to target high-risk devices and products and to evaluate the efficacy of new
technology designed to prevent needlesticks and other exposures. Since its introduction in 1992, more than
1,500 hospitals in the U.S. have acquired it for use; it has also been adopted in other countries, including
Canada, Italy, Australia, Spain, Japan, and Brazil. For further information about EPINet, call (434) 982-0702.

V. Implementing a Sharps Injury Prevention Program

The laboratory needs to be very proactive to ensure the needs of the clinical laboratory
personnel are being met in the implementation of the sharps injury prevention
program. This is especially important in large institutions, where the devices that cause
the most injuries are associated with patient care.

The following outlines the steps for implementing a Sharps Injury Prevention Program. Be
sure to document the actions taken to implement each step.

A. Establish a Multidisciplinary Team

An institution’s success in implementing a coordinated sharps injury prevention program

is dependent upon involving all of the affected parties and ensuring their input in the
process. It is recommended that a multidisciplinary team should be formed to serve as a
An NCCLS national report. ©NCCLS. All rights reserved. 5
Number 4 NCCLS

sharps injury prevention task force. The objective of the team is to develop and
implement a plan to strengthen the identification, evaluation, documentation, and use of
safety engineered sharps devices. Generally, the team is composed of representatives
from all departments, such as:

- Employee or occupational health management

- Housekeeping
- Infection control
- Laboratory
- Nursing
- Pharmacy
- Purchasing
- Quality management
- Respiratory therapy
- Risk management
- Waste management

The laboratory should form its own task group to identify sharps-injury issues and
provide feedback to the multidisciplinary team through the laboratory’s
representatives. (This is especially important for free-standing laboratory facilities).
The task group could include:

- Chief pathologists (anatomical and clinical)

- Laboratory manager
- Section manager(s)
- Staff technologist(s)
- Infection control director
- Phlebotomy supervisor
- Phlebotomist(s)
- Respiratory services manager
- Respiratory therapist(s)

Major responsibilities of the team are to:

• Develop an implementation plan for soliciting employee input, defining criteria for
device evaluation, conducting evaluations, adopting new devices and work practice
controls, and continuous improvement;

• Perform an internal review to identify devices or practices that have the potential for
sharps injury;

• Establish task groups as appropriate to implement the sharps-injury prevention plan;

and

• Review and revise the Exposure Control Plan at least annually.

6 An NCCLS national report. ©NCCLS. All rights reserved.

Volume 22 X3-R

B. Perform an Internal Review

The purpose of the internal review is to determine if there are areas that require
immediate action to reduce the potential for sharps injury. There are two major
components to the internal review:

• Log/database that is the official record of all injuries/exposures:

The intent of the review of the log of injuries/exposures is to identify any patterns that
point to a specific device or practice that bears further review and evaluation. Devices
that consistently have contributed to injury should be considered a priority for device
evaluation.

• Devices that have the potential for causing injury (see Section II):

The intent of the review of devices that have the potential for causing injury is a
prophylactic measure, i.e., to review potential hazards and prevent injury before it
happens. Input must be solicited from nonmanagerial (front-line) healthcare workers.
The front-line healthcare workers are in the best position to provide practical
information.

The following steps should be taken in conducting the internal assessment. Check them
off as you complete them.

Review/analyze the injury/exposure database:

This review assumes that the institution has been logging injury/exposure incidents. It
should be conducted by the multidisciplinary team and nonmanagerial employees.

Solicit input from employees responsible for obtaining specimens and/or performing
clinical laboratory test procedures.

Input may be solicited via:

- written surveys
- personal interviews
- focus groups
- informal problem-solving groups
- hospital committee reports.

The following questions could be asked to help solicit input relative to laboratory
devices:

What are the hazards for sharps injury in pathology, hematology, microbiology,
etc.?

How do the injuries occur?

What prevention strategies are currently being used?

An NCCLS national report. ©NCCLS. All rights reserved. 7
Number 4 NCCLS

Assess the availability and use of safer medical devices in the facility.

Prioritize devices and/or processes that should be changed to reduce the potential for
sharps injury.

Prioritization is based on analysis of the institution’s history of sharps injuries (i.e.,

through review of the database), employee input, and risk assessment.

Risk is based on:

• frequency of use (i.e., number of procedures performed on a daily basis using a

device);

• potential for transmission (e.g., a large-bore needle that contains blood has a high
potential);

• device-specific injury rate (based on review of injury database); and

• occupation-specific injury rate.

Develop an implementation plan and timeline for the identified devices and/or work
practices.

An implementation plan should specify whether the intent is to select a new device or
to change work practices.

C. Select Devices for Evaluation

The laboratory representatives should be very proactive in identifying the need for
safer medical devices and requesting evaluation of devices that may address the
need. Because much emphasis is placed on engineered devices, devices such as cut-
resistant gloves, which are especially important for autopsy and pathology, may be
overlooked.

Because of the resources required to evaluate devices, careful consideration should be

given to identifying options and selecting candidate devices. The following process steps
should be used in device selection. Check them off as you complete them.

Develop device criteria that will aid in selecting devices for evaluation. The criteria
should be based on:

• the primary use of the device;

• clinical needs;

• the desired safety goals (i.e., eliminate the hazard or reduce the risk);

• desired safety design features (i.e., active safety device; passive safety device);
and
8 An NCCLS national report. ©NCCLS. All rights reserved.
Volume 22 X3-R

• previously developed criteria (e.g., as included in the OSHA document, Safer

Needle Devices: Protecting Health Care Workers).

Research options via:

• review of current literature;

• website search;

• networking with colleagues; and

• review of vendor products.

Screen identified devices to determine priority for hands-on evaluation.

Once you have identified options and collected information, the next step is to subject
potential devices to a screening process designed to identify the top priorities for
hands-on evaluation.

The following questions may be used in screening:

• If the device is an active safety device, does the safety mechanism have to be
employed to use the device?

• Is the device reasonably easy to use?

• Is there information from the manufacturer on the device’s effect on test results?

• Is there a full array of products (e.g., sizes) available?

• Is the vendor willing to train all staff on all shifts assigned to evaluate the device?

• Will the vendor be available for all shifts during the evaluation?

• Does the device meet the identified clinical goals and performance goals without
compromising patient safety?

Select devices for hands-on evaluation.

The multidisciplinary team should recommend which devices should undergo a full
evaluation. It is important that there is team buy-in, because the evaluation will likely
affect several departments and work processes.

D. Evaluating Selected Devices

Evaluation must be viewed from the dual perspective of patient care and healthcare-
worker safety. The evaluation should involve nonmanagerial front-line workers who
routinely perform the procedure using the device. The evaluation may be relatively
informal, such as front-line workers getting together to evaluate a selected device, or the
An NCCLS national report. ©NCCLS. All rights reserved. 9
Number 4 NCCLS

evaluation may follow a more formalized process. In either case, documentation of

devices reviewed, persons involved in the review, and the reason the selection was made
is required.

When possible, a formalized process should be followed. The following process is

recommended (check them off as you complete them):

Determine length of time the device(s) will be evaluated.

The length of time required will be based on the complexity of the device, the
similarity to the product being replaced, and frequency of use. If the learning curve is
long, sufficient time must be allowed to overcome any learning bias.

Determine which services, areas/departments will be affected, directly or indirectly,

by the use of a new device(s).

Identify staff to evaluate the device(s).

Staff from each department which may adopt the device should be included. It is very
important to choose staff that routinely perform the procedure to evaluate the device.
Staff should be selected based on the frequency that they perform the procedure. Be
sure to communicate to the staff your support and appreciation for the evaluation.

Train staff on device(s) to be evaluated.

Staff should understand both the purpose of the clinical evaluation system and each
step of the process. Without adequate training for staff performing the evaluation, the
process is likely to fail. The vendor must be fundamentally involved in the training
and be on call when problems arise. Remember to provide training for staff across all
shifts.

Conduct the evaluation according to defined protocol and collect data.

Whenever possible, remove the old device and replace it with the device to be tested.
This avoids having “choice” as a variable that can influence the evaluation outcome.

This step should be undertaken using well-developed forms or models. Use a form
designed to measure staff opinion about a device. [See The Training for Development
of Innovative Control Technologies Project website (www.tdict.org) for sample
forms.] A well-constructed evaluation tool should avoid bias, be easy to complete and
score, and should reflect the performance criteria established for each device. A
numeric scoring system allows quantitative analysis of data and comparisons among
subsets of the users, which may reveal issues that were not previously identified. The
tool should include questions regarding:

• ease of use;

• activation and reliability of the safety feature (if applicable);

10 An NCCLS national report. ©NCCLS. All rights reserved.

Volume 22 X3-R

• impact on technique or procedure;

• duration of the learning curve;

• compatibility with other equipment/instrumentation; and

• observed impact on patient care.

Objectively assess the data.

Final selection factors include assessment of:

• the impact the device has on patients;

• confirmed compliance of use of the device (e.g., through observation, survey of

users);

• acceptance by clinical staff;

• potential for reduction of risk of sharps injury, as well as for meeting safety goals;
and

• cost effectiveness when compared to other prevention options.

A review of the data should elicit information regarding impact on patients, hazard
reduction, and acceptance by staff. In determining the cost effectiveness of a safety
device, the incremental cost of implementing the new device and the cost savings
achieved by reducing injuries must be taken into account.

Important considerations relative to clinical laboratory testing include:

• Are the results of laboratory tests altered?

• Are there manufacturer data available regarding the effects on performance

or results?

• Is the device under consideration compatible with current instrumentation?

It is up to the multidisciplinary team to determine if an evaluated device is

appropriate and effective. According to the Bloodborne Pathogens Standard:

• An appropriate safer medical device includes only devices whose use, based on
reasonable judgment in individual cases, will not jeopardize patient or employee
safety or be medically contraindicated;

• An effective safer medical device is a device that, based on reasonable judgment,

will make an exposure incident involving a contaminated sharp less likely to
occur in the application in which it is used.

An NCCLS national report. ©NCCLS. All rights reserved. 11

Number 4 NCCLS

If the team endorses adoption of the device, either institution-wide or in specific

departments, a step-wise approach to implementing the new device is necessary.

If no appropriate device is found to meet your goal of reducing sharps injury related
to a particular device, work practice controls that minimize risk must be instituted
until a safer medical device can be found.

E. Adopt the New Device for Routine Use

Once a new device is selected using the approach in Part D, plan to implement its use.
Check off the steps as you complete them.

Develop an implementation plan and timeline for putting the new device into
operation.

The plan should designate the phase-in process, such as department-by-department or

simultaneously across the institution (if appropriate). If there are affiliate institutions,
be sure to include implementation in the affiliates in your plan.

If the new device has the potential for affecting laboratory results, method
comparison studies and verification of reference ranges may be necessary and
should be included in the implementation plan (see NCCLS Resources).

Empower a staff member with the responsibility of overseeing the implementation.

Communicate the change “upfront” to all affected departments and staff.

Develop and implement a training program for staff across all shifts.

To ensure compliance to the change, it is necessary to make sure staff understands

that they are at risk using the old device and it is to their benefit to use the safer
device, even if there is a learning curve involved.

Develop a procedure for removing all old devices and replacing them with the new
device.

Revise all appropriate procedures, make sure the procedure manual is updated, and
communicate the changes to the staff.

If the change has resulted in a new reference range for a particular clinical laboratory
test(s), be sure to notify physicians of the change.

Incorporate device performance in appropriate staff competency evaluation programs

(to ensure that individual staff members are using the device appropriately).

Update training program for engineering and work practice controls.

Update the Exposure Control Plan to indicate implementation of a new engineering

control.
12 An NCCLS national report. ©NCCLS. All rights reserved.
Volume 22 X3-R

Congratulate staff and celebrate the success of selecting, evaluating, and adopting a
new safety device.

F. Implementing a Continuous Quality Improvement Process

Continuous quality improvement involves not only resolving problems that need
immediate attention, but also seeking opportunities for improvement where no problems
currently exist. In the latter case, improvement will minimize cost, waste, and injury;
enhance resource and process management; and facilitate patient, healthcare worker, and
institutional satisfaction in a preventive, anticipatory manner. A continuous quality
improvement process is essential in an ongoing sharps injury prevention program and
involves a systematic, total management approach that facilitates ongoing improvement
as evidenced by enhanced satisfaction. Check off each of these items as you complete
them.

Evaluate work practices on a continuous, systematic basis.

Continually monitor the use of the newly implemented devices.

Measure the satisfaction of patients and healthcare workers.

Train staff on safety and the importance of sharps injury prevention, and verify the
training on a regular basis.

Establish and monitor adherence to procedures for the timely reporting and
postexposure evaluation of all sharps-related injuries and postexposure prophylaxis
when appropriate.

Establish safety indicators and measure against the indicators.

Communicate to healthcare workers the success in injury reduction achieved by

adopting the new device.

Continually research safety authorities to remain informed of safety issues.

Foster a staff attitude that “safety is everyone’s responsibility.”

An NCCLS national report. ©NCCLS. All rights reserved. 13

Number 4 NCCLS

Bibliography
Chiarello LA. Selection of needlestick prevention devices: a conceptual framework for
approaching product evaluation. Am J Infect Control. 1995;23:386-395.

Chiarello LA. Designing and implementing an evaluation program. In: Pugliese G, Salahuddin
M (eds.). Sharps injury prevention program: a step-by-step guide. American Hospital
Association; 1999.

Glass Capillary Tubes: Joint Safety Advisory About Potential Risks. National Institute for
Occupational Safety and Health, Joint FDA/NIOSH/CDC/OSHA Advisory. February 22, 1999.

NIOSH publication 2001-108. NIOSH Alert: Preventing needlestick injuries in health care
settings. U.S. Dept. of Health and Human Services. National Institute for Occupational Safety
and Health. November, 1999:1-24. Available at: http://www.cdc.gov/niosh/2000-108.html.

Occupational exposure to bloodborne pathogens; final rule. OSHA (29 CFR 1910.1030). Federal
Register 56:64003-182; December 6, 1991.

Pugliese G, Salahuddin M (eds.). Sharps injury prevention program: a step-by-step guide.

American Hospital Association; 1999.

14 An NCCLS national report. ©NCCLS. All rights reserved.

Volume 22 X3-R

NCCLS Resources
A Quality System Model for Health Care; Approved Guideline. NCCLS document GP26-A.
Wayne, PA: NCCLS; 1999.

Clinical Laboratory Safety; Approved Guideline. NCCLS document GP17-A. Wayne, PA:
NCCLS; 1996.

Clinical Laboratory Technical Procedure Manuals; Approved Guideline – Fourth Edition.

NCCLS document GP2-A4. Wayne, PA: NCCLS; 2002. (Publication pending.)

Continuous Quality Improvement: Essential Management Approaches; Approved Guideline.

NCCLS document GP22-A. Wayne, PA: NCCLS; 1999.

Evacuated Tubes and Additives for Blood Specimen Collection – Fourth Edition; Approved
Standard. NCCLS document H1-A4. Wayne, PA: NCCLS; 1996.

Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline.

NCCLS document EP5-A. Wayne, PA: NCCLS; 1999.

Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline – Second

Edition. NCCLS document EP6-P2. Wayne, PA: NCCLS; 2001.

How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved
Guideline – Second Edition. NCCLS document C28-A2. Wayne, PA: NCCLS; 2000.

Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline.

NCCLS document EP10-A. Wayne, PA: NCCLS; 1998.

Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved
Standard – Third Edition. NCCLS document H7-A3. Wayne, PA: NCCLS; 2000.

Protection of Laboratory Workers from Occupationally Acquired Infections; Approved

Guideline – Second Edition. NCCLS document M29-A2. Wayne, PA: NCCLS; 2001.

Training Verification for Laboratory Personnel; Approved Guideline. NCCLS document GP21-
A. Wayne, PA: NCCLS; 1995.

User Protocol for Evaluation of Qualitative Test Performance; Proposed Guideline. NCCLS
document EP12-P. Wayne, PA: NCCLS; 2000.

An NCCLS national report. ©NCCLS. All rights reserved. 15

Number 4 NCCLS

Useful Websites
CDC/NIOSH Alert
Features information on the CDC/NIOSH Alert “Preventing Needlestick Injuries in Health Care
Settings.”
http://www.cdc.gov/niosh/2000-108.html

ECRI
This website discusses the June 1998 issue of ECRI’s Health Devices, which evaluated 19
needlestick-prevention devices and provides information for obtaining this document. (Keep in
mind that there are new devices on the market since 1998.)
http://healthcare.ecri.org/News_Frameset.htm

International Healthcare Worker Safety Center, University of Virginia

Features a list of safer medical devices with manufacturers and specific product names.
http://www.hsc.virginia.edu/medcntr/centers/epinet/safetydevice.html

National Institute for Occupational Safety and Health (NIOSH)

Features information on selecting, evaluating, and using sharps disposal containers.
http://www.cdc.gov/niosh/sharps1.html

NCCLS
Features consensus documents that are valuable resources for the medical testing community.
http://www.nccls.org

Occupational Safety and Health Administration (OSHA)

Describes safer alternatives to conventional glass capillary tubes.
http://www.osha-slc.gov/OshDoc/Interp_data/I19990222.html

Occupational Safety and Health Administration (OSHA) Needlestick Injuries

Features recent news, recognition, evaluation, controls, compliance, and links to information on
effective engineering controls.
http://www.osha-slc.gov/SLTC/needlestick/index.html

Sharps Injury Control Program

Established by Senate Bill 2005 to study sharps injuries in hospitals, skilled nursing facilities,
and home health agencies in California. Features a Beta version of Safety Enhanced Device
Database Listing by Manufacturer.
http://www.ohb.org/sharps.htm

Safety Sharp Device Contracts

Features safety sharp devices on contract with the U.S. Department of Veterans Affairs (VA).
http://www.va.gov/vasafety/osh-issues/needlesafety/safetysharpcontracts.htm

Training for Development of Innovative Control Technologies (TDICT)

Features a system for promoting safer medical devices.
http://www.tdict.org

16 An NCCLS national report. ©NCCLS. All rights reserved.

NCCLS T 940 West Valley Road T Suite 1400 T Wayne, PA 19087 T USA T PHONE 610.688.0100
FAX 610.688.0700 T E-MAIL: [email protected] T WEBSITE: www.nccls.org T ISBN 1-56238-460-0