I/LA27-P

Vol. 25 No. 25

Newborn Screening Follow-up; Proposed

Guideline
PLEASE
TTT
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This proposed document is published for wide and thorough review in the new,
accelerated Clinical and Laboratory Standards Institute (CLSI) consensus-review
process. The document will undergo concurrent consensus review, Board review,
and delegate voting (i.e., candidate for advancement) for 90 days.

Please send your comments on scope, approach, and technical and editorial content
to CLSI.

Comment period ends

13 December 2005

The subcommittee responsible for this document will assess all comments received
by the end of the comment period. Based on this assessment, a new version of the
document will be issued. Readers are encouraged to send their comments to Clinical
and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; Fax: +610.688.0700, or to the following e-mail address:
customerservice@clsi.org

S
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COMMENT

This guideline describes the basic principles, scope, and range of follow-up activities
within the newborn screening system.
A guideline for global application developed through the Clinical and Laboratory
Standards Institute consensus process.
Clinical and Laboratory Standards Institute
Providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards
Clinical and Laboratory Standards Institute (CLSI,
formerly NCCLS) is an international, interdisciplinary,
nonprofit, standards-developing, and educational
organization that promotes the development and use of
voluntary consensus standards and guidelines within the
healthcare community. It is recognized worldwide for the
application of its unique consensus process in the
development of standards and guidelines for patient
testing and related healthcare issues. Our process is
based on the principle that consensus is an effective and
cost-effective way to improve patient testing and
healthcare services.
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provide an open and unbiased forum to address critical
issues affecting the quality of patient testing and health
care.
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 I/LA27-P
ISBN 1-56238-582-8
Volume 25 Number 25 ISSN 0273-3099
Newborn Screening Follow-up; Proposed Guideline
Judith Tuerck, RN, MS
Jean-Louis Dhondt, MD, PhD
Pam King, MPA, RN
Beverly Gail Lim, ARNP
Fred Lorey, PhD
Marie Mann, MD, MPH, FAAP
Barbara Marriage, RD, PhD
Julie Miller, BS
Walter Reichert, BS
Brad L. Therrell, PhD

Abstract
Newborn screening for congenital conditions is a public health system composed of screening, follow-up, diagnosis management,
evaluation, and education. As part of the system, follow-up activities play an essential role in facilitating early diagnosis and
intervention for affected newborns. Clinical and Laboratory Standards Institute document I/LA27-P—Newborn Screening
Follow-up; Proposed Guideline describes the basic principles, scope, and range of follow-up activities within the newborn
screening system. It is intended for use by those involved in any aspect of follow-up, including healthcare providers, parents, and
others concerned with the health and welfare of newborns.

Clinical and Laboratory Standards Institute (CLSI). Newborn Screening Follow-up; Proposed Guideline. CLSI document
I/LA27-P (ISBN 1-56238-582-8). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2005.

The Clinical and Laboratory Standards Institute 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 CLSI/NCCLS documents. Current editions are
listed in the CLSI 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 catalog, contact us at: Telephone: 610.688.0100; Fax:
610.688.0700; E-Mail: customerservice@clsi.org; Website: www.clsi.org
Number 25 I/LA27-P

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 Clinical and Laboratory Standards
Institute, except as stated below.

Clinical and Laboratory Standards Institute 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 CLSI publication I/LA27-P—Newborn Screening

Follow-up; Proposed Guideline (ISBN 1-56238-582-8). Copies of the current edition
may be obtained from Clinical and Laboratory Standards Institute, 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 Clinical and Laboratory
Standards Institute by written request. To request such permission, address inquiries to the Executive Vice
President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA.

Copyright ©2005. Clinical and Laboratory Standards Institute.

Suggested Citation

(Clinical and Laboratory Standards Institute. Newborn Screening Follow-up; Proposed Guideline. CLSI
document I/LA27-P [ISBN 1-56238-582-8]. Clinical and Laboratory Standards Institute, 940 West Valley
Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.)

Proposed Guideline
September 2005

ISBN 1-56238-582-8
ISSN 0273-3099

ii
Volume 25
Committee Membership
Area Committee on Immunology and Ligand Assay
Dorothy J. Ball, PhD
Chairholder
Abbott Laboratories
Irving, Texas
W. Harry Hannon, PhD
Vice-Chairholder
Centers for Disease Control and
Prevention
Atlanta, Georgia
Joan H. Howanitz, MD
SUNY Brooklyn
Brooklyn, New York
Marilyn M. Lightfoote, MD, PhD
FDA Center for Devices and
Radiological Health
Silver Spring, Maryland
Robin G. Lorenz, MD, PhD
University of Alabama at
Birmingham
Birmingham, Alabama
Per N. J. Matsson, PhD
Pharmacia and Upjohn Diagnostics
Uppsala, Sweden
Subcommittee on Newborn Screening Follow-up
Judith Tuerck, RN, MS
Chairholder
Oregon Health & Science University
Portland, Oregon
Jean-Louis Dhondt, MD, PhD
St. Philibert Hospital
Lomme Cedex, France
Pam King, MPA, RN
Oklahoma State Department of Health
Oklahoma City, Oklahoma
Beverly Gail Lim, ARNP
Pediatrix Screening
Sunrise, Florida
Fred Lorey, PhD
California Department of Health
Services
Richmond, California
Marie Mann, MD, MPH, FAAP
U.S. Department of Health and Human
Services
Rockville, Maryland
Ronald J. Whitley, PhD
University of Kentucky Med. Ctr.
Lexington, Kentucky
Advisors
Kaiser J. Aziz, PhD
FDA Center for Devices and
Radiological Health
Rockville, Maryland
Linda Ivor
Gen-Probe Inc.
San Diego, California
Gerald E. Marti, MD, PhD
FDA Center for Biologics
Evaluation and Research
Bethesda, Maryland
Robert M. Nakamura, MD
Scripps Clinic & Research
Foundation
La Jolla, California
Barbara Marriage, RD, PhD
Abbott Laboratories
Columbus, Ohio
Julie Miller, BS
Nebraska Department of Health
Lincoln, Nebraska
Walter Reichert, BS
Natus Medical Inc.
San Carlos, California
Advisors
Evelyn Cherow, MPA, MA
Center for Human Advancement
La Jolla, California
Nancy S. Green, MD
March of Dimes
White Plans, New York
W. Harry Hannon, PhD
Centers for Disease Control and
Prevention
Atlanta, Georgia
I/LA27-P
Thomas A. O’Brien, PhD
Ortho Biotech Products LP
Bridgewater, New Jersey
Robert F. Ritchie, MD
Foundation for Blood Research
Scarborough, Maine
Donald R. Tourville, PhD
Zeus Scientific, Inc.
Raritan, New Jersey
Daniel Tripodi, PhD
The Sage Group
Bridgewater, New Jersey
Robert W. Veltri, PhD
Johns Hopkins Hospital
Baltimore, Maryland
Robert F. Vogt, Jr., PhD
Centers for Disease Control and
Prevention
Atlanta, Georgia
Philip R. Wyatt, MD, PhD
North York General Hospital
North York, Ontario, Canada
Mary Ann Henson, MSN
Office of Infant and Child Health
Services
Atlanta, Georgia
Kelly R. Leight
CARES Foundation, Inc.
Millburn, New Jersey
Michele A. Lloyd-Puryear, MD,
PhD
U.S. Department of Health and
Human Services
Rockville, Maryland
Dietrich Matern, MD
Mayo Clinic
Rochester, Minnesota
Ellie A. Mulcahy, RNC
Maine Department of Health and
Human Services
Augusta, Maine
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Advisors (Continued) Brad L. Therrell, PhD Ronald J. Whitley, PhD

Sheila Neier, MS
Washington State Department of
Health
Seattle, Washington
Deborah Rodriguez, RN
New York State Dept. of Health
Albany, New York
Lainie Friedman Ross, MD, PhD
University of Chicago
Chicago, Illinois
University of Texas Health Science
Center – National Newborn
Screening and Genetics Resource
Center
Austin, Texas
Keith K. Vaux, MD, LCDR, MC
USNR
United States Navy
San Diego, California
Michael S. Watson, PhD, FACMG
American College of Medical
Genetics
Bethesda, Maryland
University of Kentucky Med. Ctr.
Lexington, Kentucky
Staff
Clinical and Laboratory Standards
Institute
Wayne, Pennsylvania
John J. Zlockie, MBA
Vice President, Standards
Lois M. Schmidt, DA
Staff Liaison
Donna M. Wilhelm
Editor

Melissa A. Lewis
Assistant Editor

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Contents

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

Committee Membership........................................................................................................................ iii

Foreword .............................................................................................................................................. vii

1 Scope..........................................................................................................................................1

2 Definitions .................................................................................................................................1
2.1 Abbreviations and Acronyms .......................................................................................2
3 General Considerations Impacting Newborn Screening Follow-up ..........................................3
3.1 The Overall System ......................................................................................................3
3.2 The Role of Follow-up in the System ...........................................................................3
3.3 Participants in the Follow-up System ...........................................................................3
3.4 Laws and Rules.............................................................................................................4
3.5 Funding .........................................................................................................................5
3.6 External Advice ............................................................................................................5
4 Follow-up System Continuum ...................................................................................................5
4.1 Follow-up Continuum Flow Chart................................................................................5
4.2 Short-term Follow-up ...................................................................................................6
4.3 Long-term Follow-up..................................................................................................10
4.4 Quality Assurance and Evaluation..............................................................................11
References.............................................................................................................................................12

Additional References...........................................................................................................................13

The Quality System Approach..............................................................................................................14

Related CLSI/NCCLS Publications ......................................................................................................15

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Foreword
Newborn screening is an essential public health activity that strives to screen every newborn for a variety
of congenital conditions, which if not detected and managed early, can result in significant morbidity and
mortality. It is one of the most successful population-based screening programs ever implemented.
Screening tests separate newborns who probably have a condition from those who probably do not.
Screening is not intended to be diagnostic and newborns identified with suspicious findings must undergo
further testing and clinical evaluation.

Effective newborn screening systems provide the infrastructure for universal access and rapid follow-up.
Properly constructed, they facilitate timely intervention for affected newborns whose life and health may
be at risk. Systems for newborn hearing screening (NHS) and dried blood spot (DBS) screening are
comprised of six parts: screening, follow-up, diagnosis, management, evaluation, and education.1 Parents/legal
guardians and families, obstetric and pediatric health professionals, audiologists, birthing facilities, public
health newborn screening programs, laboratories, and other providers involved in the care of newborns
should partner to ensure that the system functions effectively. The public health newborn screening
program refers to the administrative entity responsible for development, implementation, and oversight of
policy and procedures within the screening system, where this exists.

These guidelines provide a reference for developing and providing follow-up services within a newborn
screening system. They are specifically focused on NHS and DBS screening, but applicable to other
types of universal newborn screening. The primary function of follow-up services within the newborn
screening system is to locate newborns with screening results that are “out-of-range” or “invalid,” in order
to determine if a newborn has a screened condition, and for affected newborns, to facilitate prompt
treatment and referral for subspecialty care and support services.

It is estimated that three newborns in 1000 will be affected with hearing loss and approximately one
newborn in 800 will be affected with a metabolic, endocrine, or hematologic disorder detectable by DBS
screening.2,3 This equates to an estimate of one newborn per 250 births who are at serious risk of physical
and/or developmental disabilities, or even death, as a result of their condition. Because there are genetic
components to most of the conditions included in newborn screening, birth prevalence rates may vary
depending on the screened population. Technological advances will continue to enable programs to screen
for increasing numbers of conditions in the future. This guideline provides reference information to
ensure that appropriate follow-up occurs.

The need to include follow-up services in the newborn screening system originated with the realization
that simply reporting “out-of-range” or “invalid’ screen results did not ensure appropriate or timely
treatment for affected newborns.4-6 Rapid, efficient, and effective follow-up is critical to ensure that
newborns needing further testing are evaluated quickly. Within newborn screening systems, effective
follow-up, often provided by nurses or genetic counselors, facilitates actions to ensure that the newborn is
located and receives timely confirmatory testing that leads to a rapid diagnosis (not affected or affected).
Further, it ensures that affected newborns receive prompt and appropriate referral for subspecialty care
and support services.

Follow-up activities can be divided into two broad categories, short-term and long-term follow-up.
Successful follow-up requires coordinated efforts of dedicated follow-up personnel within the newborn
screening program working with system partners, including: parents, birthing facilities, primary care
providers, appropriate subspecialty care providers, early intervention programs, and laboratory
professionals.

The aim of short-term follow-up (STFU) is to locate newborns with screening results that are “out-of-
range” or “invalid,” in order to determine if a newborn has a screened condition, and for affected

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newborns, to facilitate prompt treatment and referral for subspecialty care and support services. STFU
ends with diagnosis and documentation of treatment (if applicable) and referral information.

Long-term follow-up (LTFU) allows for the evaluation of the benefits resulting from newborn screening
throughout the life of an individual. These benefits may impact the individual, the family, and/or society.
Evaluation requires periodic assessment of indicators that are measurable, functional, and appropriate to
the condition detected. LTFU may include facilitation of care coordination services to ensure that the
needs of the affected newborn/individual and family are met.

The quality of follow-up services directly impacts the lives of families with newborns. This document
outlines the role of follow-up services within a newborn screening system, and provides guidance for
developing and maintaining effective follow-up services. Efforts have been made to reach consensus
among a representative group of newborn screening stakeholders, and they seek to describe best practices
for newborn screening follow-up. It is anticipated that these guidelines will require periodic review and
update, as screening expands and follow-up activities are required to meet increased needs.

Invitation for Participation in the Consensus Process

An important aspect of the development of this and all Clinical and Laboratory Standards Institute (CLSI)
documents should be emphasized, and that is the consensus process. Within the context and operation of
CLSI, the term “consensus” means more than agreement. In the context of document development,
“consensus” is a process by which CLSI, its members, and interested parties (1) have the opportunity to
review and to comment on any CLSI publication; and (2) are assured that their comments will be given
serious, competent consideration. Any CLSI document will evolve as will technology affecting laboratory
or healthcare procedures, methods, and protocols; and therefore, is expected to undergo cycles of
evaluation and modification.

The Area Committee on Immunology and Ligand Assay has attempted to engage the broadest possible
worldwide representation in committee deliberations. Consequently, it is reasonable to expect that issues
remain unresolved at the time of publication at the proposed level. The review and comment process is
the mechanism for resolving such issues.

The CLSI voluntary consensus process is dependent upon the expertise of worldwide reviewers whose
comments add value to the effort. At the end of a 90-day comment period, each subcommittee is obligated
to review all comments and to respond in writing to all which are substantive. Where appropriate,
modifications will be made to the document, and all comments along with the subcommittee’s responses
will be included as an appendix to the document when it is published at the next consensus level.

Key Words

Dried blood spot screening, long-term follow-up, newborn hearing screening, newborn screening,
population screening, quality assurance, short-term follow-up

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Newborn Screening Follow-up; Proposed Guideline

1 Scope
Newborn screening is a system comprised of screening, follow-up, diagnosis, management, evaluation,
and education. Follow-up is essential to ensure valid screening results are known for every eligible
newborn, that all out-of-range results are followed to definitive diagnosis and appropriate clinical
management, and that long-term outcome data are collected for program assessment and quality
assurance. The primary goal of this guideline is to improve the quality of follow-up services for newborns
screened through public health newborn screening programs. The quality of follow-up services directly
impacts the health of newborns and families. This provides guidance for effective follow-up to ensure
timely identification and treatment of affected newborns.

This guideline is limited to follow-up activities associated with invalid and out-of-range test results within
a newborn screening system. It is not intended to address other components of the overall newborn
screening system, such as screening, confirmatory testing, education, treatment, or system evaluation
practices outside of follow-up.

This guideline is intended to be used globally by public health officials and those who are involved in any
aspect of follow-up within newborn screening systems, including: maternity healthcare providers, hospital
personnel, newborn healthcare providers, pediatric subspecialty providers (e.g., hematology,
endocrinology, metabolism, pulmonology, genetics, and audiology), parents and families, other providers
involved with the care of newborns, confirmatory clinical laboratories, and newborn screening program
personnel.

2 Definitions
confirmatory/diagnostic test – test to prove or disprove the presence of a specific condition identified by
screening tests (for DBS screening, this testing is from a specimen other than the screening specimen).

false negative – “in-range” result in an affected newborn. This may occur because the test result was
normal, there was a laboratory procedure/testing error, failure to obtain or test a specimen, an inadequate
specimen, communication, or other issues; NOTE: For more information, refer to Section 4.2.2.5.

false positive – “out-of-range” result in an unaffected newborn.

follow-up – actions taken to ensure that a newborn whose screening test results are “out-of-range” or
“invalid” receives appropriate further tests and evaluation in a timely fashion; and actions taken to ensure
that the newborn screening system can evaluate the effectiveness of screening.

in-range result – screening result that is within the expected range of testing results established for a
particular condition.

intervention – specific newborn screening follow-up activity (e.g., clinical assessment, medical
management) targeted at improving health and/or developmental outcomes of an affected newborn.

invalid screen – inability to complete the screening process according to established criteria, such as
unsuitable specimen or test, no specimen or test, or incomplete information.

long-term follow-up (LTFU) – actions commencing after confirmed diagnosis in an affected individual
to ensure the screening program can evaluate the effectiveness of the program and may include the

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process of ensuring availability of ongoing intervention, services, and support to affected individuals
throughout their lives.

lost to follow-up – patient who cannot be located for completion of follow-up despite completing all
prescribed follow-up activities.

newborn dried blood spot screening (DBS) – process of collecting blood onto a filter paper collection
device, determining defined analytes by approved laboratory methods, and reporting results as
appropriate.

newborn hearing screening (NHS) – process of assessing the ability to hear sounds above a prescribed
threshold using physiologic testing techniques.

newborn screening program (NSP) – public health program that administers newborn screening within
the newborn screening system; NOTE: See also public health newborn screening below.

newborn screening system – public health system for screening newborns that includes education,
screening, follow-up, diagnosis, management, and evaluation.

out-of-range result – screening result that is outside of the expected range of testing results established
for a particular condition (includes carrier results and any findings indicating the need for further testing).

primary care provider – healthcare professional who provides the basic health care for an individual.

public health newborn screening – administrative entity responsible for development, implementation,
and oversight of policy and procedures within the screening system, where this exists; NOTE: See also
newborn screening program (NSP) above.

repeat screening – screening test administered in response to an “invalid” or “out-of-range” initial

screening test result.

screening test – test given to defined populations (newborns) to detect increased risk of a specific
condition.

short-term follow-up (STFU) – actions conducted to ensure a valid screening test has been performed in
cases of invalid initial test results, and to ensure appropriate and timely repeat/confirmatory testing and
intervention in response to out-of-range screening test results.

subspecialty care providers – individuals trained to provide specialized pediatric services in

endocrinology, metabolism, genetics, hematology, pulmonology, audiology, etc.

valid screening test – a test deemed acceptable on the basis of defined criteria and which results in a
report of “in-range” or “out-of-range.”

2.1 Abbreviations and Acronyms

DBS dried blood spot

LTFU long-term follow-up
NBS newborn screening
NHS newborn hearing screening
NSP newborn screening program
STFU short-term follow-up

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Volume 25 I/LA27-P

3 General Considerations Impacting Newborn Screening Follow-up

3.1 The Overall System

Newborn screening is a system that integrates education, screening, follow-up, diagnosis, management,
and evaluation. It is designed to reach all newborns and to provide a comprehensive evaluation for certain
congenital problems that can result in severe health consequences if undetected and untreated very early
in life. The newborn screening system must function smoothly and efficiently within its geographic and
political environment.

3.2 The Role of Follow-up in the System

An essential component within the newborn screening system is follow-up of invalid and out-of-range
test results. Short-term follow-up refers to an infrastructure with the capacity for rapid transmittal of
screen results identified as “out of range” or “invalid,” followed by appropriate action(s). In order to
clarify screening results, further testing and clinical evaluation are required to achieve timely diagnosis
and intervention for affected newborns. This may include individual contact with the newborn’s
parent/legal guardian by the public health newborn screening program when other systems of contact fail.
Short-term follow-up includes facilitating access to subspecialty care and ancillary services when needed.
Short-term follow-up ends with the confirmation of a diagnosis, and for affected newborns,
documentation of initiation of appropriate clinical management and support services.

Long-term follow-up provides a mechanism for determining if the newborn screening system is
accomplishing its intended goal of improving health outcomes. Long-term follow-up includes an
infrastructure with the capacity for periodic monitoring of selected outcome indicators appropriate for
evaluating the efficacy of newborn screening. Data obtained through long-term follow-up can be useful
in improving and refining the newborn screening system. Long-term follow-up may include facilitation of
services to ensure coordinated, comprehensive care for the affected individual and family.

3.3 Participants in the Follow-up System

The Newborn Screening Program (NSP) has the essential responsibility of ensuring that an adequate
follow-up system is in place and that protocols exist that maximize the health benefits of newborn
screening. Follow-up must be provided in a timely, effective, and efficient manner with attention to
professionalism, cultural sensitivity, and coordinated care. Policies and written procedures must carefully
define the roles and responsibilities of all participants in the follow-up system. In addition to appropriate
documentation of all follow-up actions, a system of quality assurance and program evaluation should
exist. The NSP should also coordinate and communicate with other public child health programs to
ensure that an identified newborn receives appropriate and necessary intervention services.

The assignment of roles and responsibilities of families, primary healthcare providers, and pediatric
subspecialty providers in newborn screening follow-up may vary between newborn screening systems,
due to different public health structures. The NSP must define the responsibilities of each group based on
the organizational aspects and resources that govern the program.

The responsibilities of families within follow-up may include:

• identifying a primary healthcare provider (if appropriate) for result reporting by the time the newborn
is discharged from the birth facility;

• providing accurate complete demographic information, in order to facilitate follow-up;

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Clinical and Laboratory Standards Institute. All rights reserved. 3
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• verifying that newborn screening occurs and that results are known;

• assisting with appropriate actions taken in response to out-of-range results or invalid screens; and

• participating in decision-making around possible interventions and ensuring adherence to the decided
course of action.

The follow-up responsibilities of the screening program may include:

• ensuring other stakeholders, including families, are aware of their responsibilities;

• acknowledging the role of families as primary stakeholders in the newborn screening system and
including them in decision-making processes;

• taking all defined actions to ensure follow-up occurs;

• ensuring primary healthcare providers and birthing facilities have access to information about the
early interventions for the screened conditions, the follow-up processes, and the significance of the
test results (including the possibility of false-positive or false-negative results); and

• ensuring inclusion of pediatric sub-specialists in newborn screening program policy development as

technical/clinical consultants.

The role and responsibilities of primary healthcare providers and birthing facilities in newborn screening
follow-up may include:

• ensuring that newborn screening occurs and that results are known;
• serving as the linkage between the NSP and the affected newborn and family;
• being the first contact in transmitting out-of-range or invalid screening test results;
• communicating the results in a knowledgeable, sensitive fashion to the families;
• serving as a resource for the families and the NSP;
• assisting with appropriate actions;
• facilitating repeat or confirmatory testing and appropriate subspecialty care; and
• reporting the results of confirmatory tests and the diagnosis to the screening program.

The role and responsibilities of pediatric subspecialty providers in newborn screening follow-up may
include:

• assisting with development of confirmatory and diagnostic protocols;

• assisting with confirmatory and diagnostic evaluations and other interventions;
• providing clinical/medical advice to the screening program;
• collecting and sharing information for effective patient management and system evaluation; and
• collaborating with primary healthcare providers to establish shared management plans in partnership
with the child and family.

3.4 Laws and Rules

Newborn screening may be governed by laws or rules that impact follow-up activities. Newborn
screening policy makers and stakeholders should be familiar with all laws and rules that might impact
newborn screening follow-up, including genetic privacy issues. References to any restrictions should be
available and cited in appropriate program literature, such as information manuals for professionals.
Where specific restrictions exist, their observance should be adequately documented.
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3.5 Funding

Newborn screening (NBS) systems are financed in various ways including fees, private insurers, grants,
and governmental resources, including national/regional/local healthcare insurance and direct
appropriations. It is essential that any financing strategy include all components of the newborn screening
system, including comprehensive cost accounting of short-term and long-term follow-up activities.7
Ancillary services that are part of the follow-up process, such as various types of counseling, family
testing, and other linkage processes and services, should be included as part of system financing.

The costs of diagnosis and treatment for affected individuals should be included in the NBS financing
scheme, if they are not covered elsewhere in the healthcare system. Screening programs have a
responsibility to ensure that any affected newborn has access to care regardless of ability to pay.8 If access
to treatment is denied, the benefits of screening are lost for that newborn and the family, and diluted for
society as a whole.

Screening programs should include the cost of long-term follow-up surveillance in financial
considerations. The functional outcome of affected individuals, the costs of their care, and other financial
and family issues are necessary to evaluate the overall efficacy of newborn screening. Shared data,
(nationally or globally), for all aspects of the newborn screening systems may be necessary to truly
determine screening effectiveness, and these costs should be included in financing plans.

3.6 External Advice

An external advisory committee, comprised of multiple stakeholders, should provide input and advice
from the community to the newborn screening policy makers.8 In addition to providing advice on
technical and policy matters, this committee can also serve to externally evaluate program data as a means
of assessing whether program goals are being met. In particular, data on numbers of patients recalled,
numbers of patients diagnosed, number lost to follow-up, and time from birth to diagnosis provide critical
program information useful for evaluating follow-up efficiency and effectiveness.9 The advisory
committee’s role in advising and evaluating follow-up activities should be clearly defined. In cases where
sufficient sub-specialists are involved with the advisory committee, they may also serve as program
consultants for developing intervention protocols.

4 Follow-up System Continuum

4.1 Follow-up Continuum Flow Chart

Newborn screening follow-up begins at the point at which a screening test result is available or when
there is information that no test has been performed. This flow chart outlines the follow-up process,
including possible outcomes and activities needed for successful follow-up within the newborn screening
process. It can be applied to newborn hearing and blood spot screening. The information in the following
section is based on the procedures depicted in the flow chart.

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Clinical and Laboratory Standards Institute. All rights reserved. 5
Number 25 I/LA27-P

“In-Range” Screening Test “Invalid”

Report “In-Range” Follow- up for New Lost
Result Screening
Screening
(Including No Test)

“Out-of-Range”

Carrier Requires Results Not Definitive

Facilitate Counseling Requires Close Case
Follow-up
Follow- up Facilitate Rescreening
Short-term Follow-up

Results Appear Definitive

Not Affected
Facilitate Confirmatory Testing

Not Affected Confirmatory Testing

Close Case Follow - up
Follow-up Monitor
Monitor
Clinical
Clinical Lost
Confirmation
Confirmation Observation
Observation
Is Not Definitive

Definitive Diagnosis

• / Management
Facilitate Intervention
• Facilitate Appropriate Services Definitive Diagnosis
• Maintain in Case Registry

Key to Colors
Long-term
Follow-up

• Periodically Monitor Care Coordination

Action or Outcome
• Periodically Monitor Functional Outcomes
• Evaluate Long-term data Lost to Follow - up Possible

Process End Point

Figure 1. The Newborn Screening Follow-up Process

4.2 Short-term Follow-up

Facilitate, monitor, and document follow-up of any “out-of-range” or “invalid” screen result.

Centralized administration of follow-up activities provides efficient and effective oversight and
monitoring. The primary responsibility of the follow-up component of the newborn screening system is to
facilitate communication of out-of-range and invalid screening results and to ensure and facilitate timely
compliance with requested actions. There is a responsibility to facilitate screening in cases where a
newborn has not been screened.

Follow-up requires sufficient personnel with adequate knowledge of the detected conditions to facilitate
comprehensive follow-up service delivery. Attention should be given to cross training, staff development,
and continuing education.

4.2.1 Communication/Documentation Issues

4.2.1.1 Written Procedures

Develop and maintain written procedures detailing each step of the follow-up process and include
specific requirements of program enabling statutes or rules.

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Procedures should be clear, concise, and contain timed follow-up actions. Follow-up procedures should
be designed to achieve resolution and begin intervention prior to occurrence of morbidity and mortality
associated with the condition. Procedures must be realistic, have designated starting and end points, and
represent actual program practices. A protocol must exist to close cases lost to follow-up. Written follow-
up procedures should be updated as needed, and periodically reviewed and approved by the newborn
screening program’s external advisory committee.

4.2.1.2 Communication

Communicate information in a timely, consistent, clear, and concise manner.

Follow-up communications must include rapid, confidential exchanges of information in a continuous

loop between the newborn screening program, the birthing facility, the newborn’s primary and
subspecialty care providers, and parents. Follow-up information for professionals must be useful for them
to provide accurate information to parents in a sensitive way. There should be open communication
between all members of the screening system, keeping in mind that changes in one arena can have
profound effects on the function of others.

4.2.1.3 Education

Provide educational materials for healthcare professionals and parents to facilitate understanding of the
suspected condition.

A responsibility of newborn screening follow-up is to provide information on next steps for the healthcare
provider and basic educational material about the condition under investigation for the parent. More
detailed information about conditions of interest should also be available for distribution as needed. All
information should be at an appropriate literacy level. In addition, information for parents should be
culturally sensitive and translated into other languages where needed.

4.2.1.4 Reporting

Report “out-of-range” and “invalid” screen results rapidly to achieve timely identification of affected
newborns.

Results should be reported in a manner consistent with the urgency of intervention. With time-critical
conditions, follow-up should occur without delay, including weekends and holidays if appropriate contact
can be made and intervention started. Notification of results requiring urgent action should be according
to a “fail-safe” system (e.g., notification of both the primary care provider and the designated sub-
specialist). In addition to phone calls, urgent results should be followed with paper or electronic
notification of the primary care provider. Nonurgent “out-of-range” results, as defined by the program,
may be reported by letter or other routine communication (i.e., electronic). The NBS program may need
to contact parents directly if the steps outlined above are not effective.

For all out-of-range results, the following should be reviewed with the newborn’s healthcare provider:

• verify that the contacted provider is the newborn’s care provider or agrees to act on the reported
results;

• develop the plan for completion of recommended actions and ensure the provider understands their
role;

• confirm knowledge of available sub-specialist for consultation; and

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• obtain assurance that confirmatory information will be reported to the newborn screening program.

Table 1. Elements to Provide to the Newborn’s Primary Care Provider

Information Provided to the Primary Care Provider Out of Range Invalid
Newborn’s identifying information (name, date and time of birth), X X
place of birth, and national or local health number
Parent information (i.e., mother’s name, home phone, and address [if X X
available])
Screen results or report X X
Required actions (e.g., repeat screen, confirmatory testing, clinical X X
actions [such as soy formula or avoid fasting]) and evaluation*
Timeline, steps, and instructions to complete necessary actions* X X
Instructions to notify the newborn screening program if unsuccessful X X
in contacting the parents or if there is a change in the primary care
provider
Pediatric sub-specialists resource information for consultation or X
referral with phone number(s)
Fact sheet – condition information and consequences if untreated X
Contact information for newborn screening program’s follow-up X X
personnel (e.g., contact person, phone number, e-mail, and fax)
Reporting requirements to the newborn screening program include X
items, such as confirmatory test results, treatment date, etc.
* 'Act Sheets'3 with 'just in time' information may supplement or reinforce this item.

4.2.1.5 Monitoring and Documentation

Monitor and document all follow-up activities for “out-of-range” and “invalid” screen results.

Newborn screening follow-up should actively monitor and document the actions taken until case
resolution. Frequency and urgency of actions should be based on the earliest age at which adverse effects
of the untreated condition may occur.

All follow-up communications about an individual newborn are confidential and should be documented in
the newborn screening follow-up program’s record, according to applicable rules and regulations. The
record should be kept current and at a minimum, should contain the following:

• diagnosis (affected, not affected, lost to follow-up);

• diagnosis date;
• treatment/intervention date (if applicable);
• test result(s) on which diagnosis is based;
• diagnosed cases: referral information (e.g., subspecialty providers, support services), enrollment in
early intervention, and long-term follow-up activities; and
• cases with an uncertain diagnosis: clinical surveillance and action plan to achieve case resolution.

4.2.1.6 Information Systems

Maintain information systems that include elements to assist in follow-up.

A program information system should provide for collection, storage, and use of data for various follow-
up activities. The system should facilitate comprehensive tracking for newborns with out-of-range or
invalid screening results. It should allow documentation of follow-up actions, generation of various

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reports and letters, and include alerts that follow-up actions are needed. It should also assist programs in
maintaining and reporting data to state, provincial, or national organizations.

The information system should be designed to make information available to those who have use and
need for it, including patients, parents, health professionals, and program staff. It should allow for access
at the time of a patient encounter for entry and retrieval of information by authorized individuals. System
design should include ease of use and integration into follow-up workflow. The information system
should ensure compliance with governmental security, privacy, and storage requirements. A
comprehensive quality assurance process that ensures accuracy and completeness of electronic
information should exist.

The information system should be designed to allow linkage/integration with other relevant child health
information systems and may allow for the electronic sharing of relevant information in a secure
environment to people who have a right to know.10 Successful integration of child health information
systems can improve efficiency and effectiveness of newborn screening follow-up and should be
encouraged. Integration with national and international databases for evaluation and comparison of
follow-up activities should also be considered.

4.2.2 Short-term Follow-up Issues

4.2.2.1 Newborns Not Screened

Develop and maintain written procedures that define efforts to identify unscreened newborns.

Newborn screening must be available to all infants born within a screening jurisdiction. Policies or
regulations should assign responsibility for screening, including out-of-hospital births. A system should
exist for timely comparison of births to newborns screened. Procedures should exist to follow-up and
ensure screening for unscreened newborns.

4.2.2.2 Newborns With Unique Follow-up Considerations

Develop and maintain written procedures for newborns with special follow-up considerations, such as
family history, adoption, newborns who move or reside outside of the screening jurisdiction, and
newborns with special risk factors.

For newborns with a family history of a known condition included in the screening panel, diagnostic
protocols should be instituted without waiting for a screening test result. Follow-up actions may differ for
these newborns, but should ensure that routine required screening for other conditions has also occurred.

For newborns placed in foster homes or adopted, extra follow-up effort may be needed to appropriately
identify and locate these newborns in the event of an out-of-range or invalid screening test result. This
may include communication with government or adoption agencies, legal counsels, and foster or adoptive
parents.

For newborns who move or reside outside of the screening jurisdiction, follow-up collaboration and
cooperation between programs should occur to avoid delays in resolving such cases. There may be
instances where follow-up activities may require communication with and/or transfer of follow-up
responsibilities to providers in other jurisdictions. In some cases, the NBS program may need to contact
parents directly.

Newborns with special risk factors may require extended or special follow-up. For example, newborns
with auditory risk factors may require biannual follow-up until the age of three years.11 Screening
programs should define responsibility for such follow-up.
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Newborns born out of hospital, those in intensive care units, or those born prematurely may require
additional follow-up actions to facilitate and validate newborn screening test results.

4.2.2.3 Carrier Detection

Inform healthcare providers and parents of newborns identified as carriers of available counseling and
testing resources.

Because newborn screening may detect carriers either through screening processes or through
confirmatory testing and diagnosis, follow-up procedures are indicated. The extent of carrier follow-up
should not interfere with the follow-up of clinically significant conditions. Programs should have
procedures in place that specify how carrier status will be reported and how counseling and testing
services may be obtained.

4.2.2.4 False Positives

Monitor “false-positive” screening results to improve screening efficiency and follow-up activities.

Expected ranges for analytes or other testing results used in the newborn screening process are
determined through continued correlation of laboratory results and clinical outcomes. Improved efficiency
of the screening procedure can be obtained through continued monitoring and assessment of false-positive
results. Communication within the screening system, including the external advisory committee, is an
essential element of this process and should be facilitated through follow-up activities.

4.2.2.5 Affected Newborns Not Identified By Screening (False Negatives)

Maintain surveillance of reported cases diagnosed outside of the screening system.

Delayed diagnosis of an affected newborn may occasionally occur for various reasons, including biologic
variation, limitations of testing methodologies/procedures, communication, or other issues within the
newborn screening system. Screening programs should seek to identify cases diagnosed outside of the
newborn screening system using public health reporting systems, subspecialty, or primary care providers.
Investigation of such cases is needed to determine if screening protocols or system changes are needed.

4.2.2.6 Lost to Follow-up

Develop and maintain written procedures that define reasonable efforts to locate newborns with out-of-
range and invalid test results and the point at which cases should be closed.

Newborn screening typically relies on the primary healthcare provider to achieve needed follow-up
actions. At times, there may be the need to use public health providers, birth facilities, and/or law
enforcement to assist in locating newborns needing urgent follow-up. Occasionally, there are newborns
for whom follow-up cannot be completed and for whom the case must be closed as “lost to follow-up.”
Case closures, where necessary, should occur in a time-limited manner and the primary care provider
should be notified in writing of case closure. Cases lost to follow-up should be administratively reviewed
to determine factors contributing to the loss and whether changes in follow-up practices are necessary.

4.3 Long-term Follow-up

Provide long-term tracking of outcome and care coordination services.

In order to evaluate the efficacy of screening for individual conditions, newborn screening programs
should collect data regarding functional abilities and health status of affected individuals and their use of
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Volume 25 I/LA27-P

appropriate follow-up services. These data should be collected in collaboration with primary care and
subspecialty care providers, other medical and support service providers, and/or parents/affected
individuals. Given the rarity of these conditions, efforts should be made nationally and internationally to
define appropriate data elements, develop mechanisms for data pooling and analysis, and create/expand
effective models for long-term follow-up services.

4.4 Quality Assurance and Evaluation

Develop and maintain a quality assurance plan that assesses follow-up activities utilizing performance
indicators.
Evaluation should be a continuous process to monitor, assess, and review effectiveness of follow-up
activities within the context of the newborn screening system. The quality assurance plan should be
designed to identify follow-up strength and/or weakness in order to improve follow-up. Criteria for
performance standards can be derived from published guidelines, policies, and procedures. Performance
evaluation and assessment indicators for follow-up should be specific to the follow-up process, and may
include items such as:

• number and percentage of newborns lost to follow-up;

• time from test result availability to notification of primary care provider;
• time from test result availability to diagnosis and date of treatment (if applicable);
• number and percentage of newborns with a valid screening test; and
• number of invalid screenings that are repeated.

Evaluation of follow-up should be included in the overall newborn screening system quality assurance
plan. The quality assurance plan should be reviewed and approved by the external advisory committee.
Periodic reports of follow-up performance should be available to all newborn screening stakeholders.

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References
1
Therrell BL. U.S. newborn screening policy dilemmas for the twenty-first century. Mol Genet Metab. 2001;74:64-74.
2
Kennedy C, McCann D. Universal neonatal hearing screening moving from evidence to practice. Arch Dis Child Fetal Neonatal Ed. 2004;
89:F378-F383.
3
Newborn screening: toward a uniform screening panel. Federal Register: March 8, 2005 (Vol 7, Num 44).
4
Holtzman C, Slazyk WE, Cordero JF, Hannon WH. Descriptive epidemiology of missed cases of Phenylketonuria and congenital
hypothyroidism. Pediatrics. 1986;78:553-558.
5
Listernick R, Frisone L, Silverman BL. Delayed diagnosis of infants with abnormal neonatal screens. JAMA. 1992;267:8, 1095-1099.
6
Hoffman TL, Simon EM, Ficicioglu C. Biotinidase deficiency: the importance of adequate follow-up for an inconclusive newborn screening
result. Eur J Pediatr. 2005;164(5)298-300.
7
American Academy of Pediatrics. Serving the family from birth to the medical home. Newborn screening: A blueprint for the future.
Pediatrics. 2000(suppl);386-427.
8
Therrell BL, Panny SR, Davidson A, et al. U.S. newborn screening system guidelines. Statement of the council of regional networks for
genetic services. Screening. 1992;1:135-147.
9
U.S. Department of Health and Human Resources. Healthy People 2010. 2nd ed. With Understanding and Improving Health and Objectives
for Improving Health. 2 vols. Washington DD: U.S. Government Printing Office, November 2000.
10
Grams RR, ed. 1988 Hawaii International Conference on System Sciences: 8M Computer Newborn Screening. J Med Syst.
1988;(12)2:69-120.
11
Joint Committee on Infant Hearing. Year 2000 position statement: principles and guidelines for early hearing detection and
intervention programs. Pediatrics. 2000;106:798-817.

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12 Clinical and Laboratory Standards Institute. All rights reserved.
Volume 25 I/LA27-P

Additional References
American Academy of Pediatrics Medical Home Initiatives for Children With Special Needs Project Advisory Committee. The
Medical Home. Pediatrics. 2002;1545-1547.

Association of Public Health Laboratories and Council of Regional Genetic Networks. Recommendations and Standardization of
Neonatal Screening. 1999.

Carey RG. Improving Healthcare With Control Charts. Basic and Advanced SPC Methods and Case Studies. Milwaukee,
Wisconsin: ASQ Quality Press; 2003.

Linzer DS, Lloyd-Puryear MA, Mann M, Kogan MD. Evolution of a child health profile initiative. J Public Health Management
Practice. 2004: Nov (suppl) S16-23.

Pass KA, et al, eds. U.S. Newborn Screening System Guidelines II: Follow-up of Children, Diagnosis, Management, and
Evaluation Statement of the Council of Regional Networks for Genetic Services (CORN). Pediatrics. 2000 (suppl);137:S3-S7.

Therrell BL. Data integration and warehousing. Coordination between newborn screening and related public health programs.
Southeast Asian J of Tropical Medicine and Public Health. 2003:34(suppl);3:63-68.

Williams SD, Hollinshead W. Perspectives on integrated child health information systems: parents, providers and public health. J
Public Health Management Practice. 2004 (suppl);S57-S60.

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Number 25 I/LA27-P

The Quality System Approach

Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the
development of standards and guidelines, which facilitates project management; defines a document structure via a
template; and provides a process to identify needed documents. The approach is based on the model presented in the
most current edition of CLSI/NCCLS document HS1—A Quality Management System Model for Health Care. The
quality management system approach applies a core set of “quality system essentials” (QSEs), basic to any
organization, to all operations in any healthcare service’s path of workflow (i.e., operational aspects that define how
a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or
service, serving as a manager’s guide. The quality system essentials (QSEs) are:

Documents & Records Equipment Information Management Process Improvement

Organization Purchasing & Inventory Occurrence Management Service & Satisfaction
Personnel Process Control Assessment Facilities & Safety

I/LA27-P addresses the quality system essentials (QSEs) indicated by an “X.” For a description of the other
documents listed in the grid, please refer to the Related CLSI/NCCLS Publications section on the following page.
Purchasing &

Improvement
Organization

Management

Management
Information

Satisfaction
Assessment

Facilities &
Occurrence
Documents

Equipment
& Records

Service &
Personnel

Inventory

Control
Process

Process

Safety
X
LA4
Adapted from CLSI/NCCLS document HS1—A Quality Management System Model for Health Care.

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14 Clinical and Laboratory Standards Institute. All rights reserved.
Volume 25 I/LA27-P

Related CLSI/NCCLS Publications∗

LA4-A4 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Fourth
Edition (2003). This document addresses the issues associated with specimen collection, the filter paper
collection device, and the transfer of blood onto filter paper, and provides uniform techniques for collecting
the best possible specimen for use in newborn screening programs.

∗
Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process;
therefore, readers should refer to the most recent editions.

©
Clinical and Laboratory Standards Institute. All rights reserved. 15

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System
Centro Diagnostico Italiano (Milano,
Italy)
Chang Gung Memorial Hospital
(Taiwan)
Children’s Healthcare of Atlanta (GA)
Children’s Hospital (NE)
Children’s Hospital Central
California
Children’s Hospital & Clinics (MN)
Childrens Hospital of Wisconsin
Children’s Hospital Medical Center
(Akron, OH)
Chinese Association of Advanced
Blood Bankers (Beijing)
Christus St. John Hospital (TX)
City of Hope National Medical
Center (CA)
Clarian Health - Methodist Hospital
(IN)
CLSI Laboratories (PA)
Community College of Rhode Island
Community Hospital of Lancaster (PA)
Community Hospital of the Monterey
Peninsula (CA)
CompuNet Clinical Laboratories (OH)
Covance Central Laboratory
Services (IN)
Creighton University Medical Center
(NE)
Detroit Health Department (MI)
DFS/CLIA Certification (NC)
Diagnostic Accreditation Program
(Vancouver, BC, Canada)
Diagnósticos da América S/A
(Brazil)
Dianon Systems (OK)
Dr. Everett Chalmers Hospital (New
Brunswick, Canada)
Duke University Medical Center
(NC)
Dwight David Eisenhower Army
Medical Center (GA)
Emory University Hospital (GA)
Enzo Clinical Labs (NY)
Florida Hospital East Orlando
Focus Technologies (CA)
Focus Technologies (VA)
Foothills Hospital (Calgary, AB,
Canada)
Franciscan Shared Laboratory (WI)
Fresno Community Hospital and
Medical Center
Gamma Dynacare Medical
Laboratories (Ontario, Canada)
Gateway Medical Center (TN)
Geisinger Medical Center (PA)
General Health System (LA)
Guthrie Clinic Laboratories (PA)
Hagerstown Medical Laboratory
(MD)
Harris Methodist Fort Worth (TX)
Hartford Hospital (CT)
Headwaters Health Authority
(Alberta, Canada)
Health Network Lab (PA)
Health Partners Laboratories (VA)
High Desert Health System (CA)
Highlands Regional Medical Center
(FL)
Hoag Memorial Hospital
Presbyterian (CA)
Holy Cross Hospital (MD)
Hôpital Maisonneuve - Rosemont
(Montreal, Canada)
Hôpital Saint-Luc (Montreal, Quebec,
Canada)
Hospital Consolidated Laboratories
(MI)
Hospital de Sousa Martins (Portugal)
Hospital for Sick Children (Toronto,
ON, Canada)
Hotel Dieu Grace Hospital (Windsor,
ON, Canada)
Huddinge University Hospital
(Sweden)
Humility of Mary Health Partners
(OH)
Hunter Area Health Service
(Australia)
Hunterdon Medical Center (NJ)
Indiana University
Innova Fairfax Hospital (VA)
Institute of Medical and Veterinary
Science (Australia)
International Health Management
Associates, Inc. (IL)
Jackson Health System (FL)
Jacobi Medical Center (NY)
John H. Stroger, Jr. Hospital of Cook
County (IL)
Johns Hopkins Medical Institutions
(MD)
Kaiser Permanente (MD)
Kantonsspital (Switzerland)
Kimball Medical Center (NJ)
King Abdulaziz Medical City –
Jeddah (Saudi Arabia)
King Faisal Specialist Hospital
(Saudi Arabia)
LabCorp (NC)
Laboratoire de Santé Publique du
Quebec (Canada)
Laboratorio Dr. Echevarne (Spain)
Laboratório Fleury S/C Ltda.
(Brazil)
Laboratorio Manlab (Argentina)
Laboratory Corporation of America
(NJ)
Lakeland Regional Medical Center
(FL)
Lawrence General Hospital (MA)
Lewis-Gale Medical Center (VA)
L'Hotel-Dieu de Quebec (Canada)
Libero Instituto Univ. Campus
BioMedico (Italy)
Lindy Boggs Medical Center (LA)
Loma Linda Mercantile (CA)
Long Beach Memorial Medical
Center (CA)
Long Island Jewish Medical Center
(NY)
Los Angeles County Public Health
Lab (CA)
Maimonides Medical Center (NY)
Marion County Health Department
(IN)
Martin Luther King/Drew Medical
Center (CA)
Massachusetts General Hospital
(Microbiology Laboratory)
MDS Metro Laboratory Services
(Burnaby, BC, Canada)
Medical Centre Ljubljana (Slovinia)
Medical College of Virginia
Hospital
Medical Research Laboratories
International (KY)
Medical University of South
Carolina
Memorial Medical Center
(Napoleon Avenue, New Orleans,
LA)
Methodist Hospital (Houston, TX)
Methodist Hospital (San Antonio,
TX)
Middlesex Hospital (CT)
Montreal Children’s Hospital
(Canada)
Montreal General Hospital (Canada)
National Healthcare Group
(Singapore)
National Serology Reference
Laboratory (Australia)
NB Department of Health &
Wellness (New Brunswick, Canada)
The Nebraska Medical Center
Nevada Cancer Institute
New Britain General Hospital (CT)
New England Fertility Institute (CT)
New York City Department of
Health & Mental Hygiene
NorDx (ME)
North Carolina State Laboratory of
Public Health
North Central Medical Center (TX)
North Coast Clinical Laboratory
(OH)
North Shore - Long Island Jewish
Health System Laboratories (NY)
North Shore University Hospital
(NY)
Northern Plains Laboratory (ND)
Northwestern Memorial Hospital
(IL)
Ochsner Clinic Foundation (LA)
Onze Lieve Vrouw Ziekenhuis
(Belgium)
Orlando Regional Healthcare System
(FL)
Ospedali Riuniti (Italy)
The Ottawa Hospital
(Ottawa, ON, Canada)
Our Lady of the Resurrection
Medical Center (IL)
Pathology and Cytology
Laboratories, Inc. (KY)
Pathology Associates Medical
Laboratories (WA)
Phoenix College (AZ)
Piedmont Hospital (GA)
Presbyterian Hospital of Dallas (TX)
Providence Health Care (Vancouver,
BC, Canada)
Provincial Laboratory for Public
Health (Edmonton, AB, Canada)
Quest Diagnostics Incorporated
(CA)
Quintiles Laboratories, Ltd. (GA)
Regional Health Authority Four
(NB, Canada)
Regions Hospital
Rex Healthcare (NC)
Rhode Island Department of Health
Laboratories
Robert Wood Johnson University
Hospital (NJ)
Sahlgrenska Universitetssjukhuset
(Sweden)
St. Alexius Medical Center (ND)
St. Agnes Healthcare (MD)
St. Anthony Hospital (CO)
St. Anthony’s Hospital (FL)
St. Barnabas Medical Center (NJ)
St. Christopher’s Hospital for
Children (PA)
St-Eustache Hospital (Quebec,
Canada)
St. John Hospital and Medical
Center (MI)
St. John Regional Hospital
(St. John, NB, Canada)
St. John’s Hospital & Health Center
(CA)
St. Joseph’s Hospital – Marshfield
Clinic (WI)
St. Jude Children’s Research
Hospital (TN)
St. Mary Medical Center (CA)
St. Mary of the Plains Hospital
(TX)
St. Michael’s Hospital (Toronto,
ON, Canada)
St. Vincent’s University Hospital
(Ireland)
Ste. Justine Hospital (Montreal, PQ,
Canada)
San Francisco General Hospital
(CA)
Santa Clara Valley Medical Center
(CA)
Seoul Nat’l University Hospital
(Korea)
Shands at the University of Florida
South Bend Medical Foundation
(IN)
South Western Area Pathology
Service (Australia)
Southern Maine Medical Center
Specialty Laboratories, Inc. (CA)
State of Connecticut Dept. of Public
Health
State of Washington Department of
Health
Stony Brook University Hospital
(NY)
Stormont-Vail Regional Medical
Center (KS)
Sun Health-Boswell Hospital (AZ)
Sunnybrook Health Science Center
(ON, Canada)
Sunrise Hospital and Medical Center
(NV)
Swedish Medical Center -
Providence Campus (WA)
Tenet Odessa Regional Hospital
(TX)
The Children’s University Hospital
(Ireland)
The Permanente Medical Group
(CA)
Touro Infirmary (LA)
Tri-Cities Laboratory (WA)
Tripler Army Medical Center (HI)
Truman Medical Center (MO)
Tuen Mun Hospital (Hong Kong)
UCLA Medical Center (CA)
UCSF Medical Center (CA)
UNC Hospitals (NC)
Unidad de Patologia Clinica
(Mexico)
Union Clinical Laboratory (Taiwan)
United Laboratories Company
(Kuwait)
Universita Campus Bio-Medico
(Italy)
University of Chicago Hospitals
(IL)
University of Colorado Hospital
University of Debrecen Medical
Health and Science Center
(Hungary)
University of Maryland Medical
System
University of Medicine & Dentistry,
NJ University Hospital
University of MN Medical Center -
Fairview
University of the Ryukyus (Japan)
The University of the West Indies
University of Virginia Medical
Center
University of Washington
US LABS, Inc. (CA)
USA MEDDAC-AK
UZ-KUL Medical Center (Belgium)
VA (Tuskegee) Medical Center
(AL)
Virginia Beach General Hospital
(VA)
Virginia Department of Health
Washington Adventist Hospital
(MD)
Washington State Public Health
Laboratory
Washoe Medical Center
Laboratory (NV)
Wellstar Health Systems (GA)
West China Second University
Hospital, Sichuan University (P.R.
China)
West Jefferson Medical Center (LA)
Wilford Hall Medical Center (TX)
William Beaumont Army Medical
Center (TX)
William Beaumont Hospital (MI)
Winn Army Community Hospital
(GA)
Winnipeg Regional Health
Authority (Winnipeg, Canada)
York Hospital (PA)

OFFICERS BOARD OF DIRECTORS

Thomas L. Hearn, PhD, Susan Blonshine, RRT, RPFT, FAARC J. Stephen Kroger, MD, MACP
President TechEd COLA
Centers for Disease Control and Prevention
Maria Carballo Jeannie Miller, RN, MPH
Robert L. Habig, PhD, Health Canada Centers for Medicare & Medicaid Services
President Elect
Abbott Laboratories Kurt H. Davis, FCSMLS, CAE Gary L. Myers, PhD
Canadian Society for Medical Laboratory Science Centers for Disease Control and Prevention
Wayne Brinster,
Secretary Russel K. Enns, PhD Klaus E. Stinshoff, Dr.rer.nat.
BD Cepheid Digene (Switzerland) Sàrl

Gerald A. Hoeltge, MD, Mary Lou Gantzer, PhD James A. Thomas

Treasurer Dade Behring Inc. ASTM International
The Cleveland Clinic Foundation
Lillian J. Gill, DPA Kiyoaki Watanabe, MD
Donna M. Meyer, PhD, FDA Center for Devices and Radiological Health Keio University School of Medicine
Immediate Past President
CHRISTUS Health

Glen Fine, MS, MBA,

Executive Vice President
 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: customerservice@clsi.org T WEBSITE: www.clsi.org T ISBN 1-56238-582-8