Newborn Screening: Characteristics of State Programs (17-MAR-03, 
GAO-03-449).							 
                                                                 
Each year state newborn screening programs test 4 million	 
newborns for disorders that require early detection and treatment
to prevent serious illness or death. GAO was asked to provide the
Congress with information on the variations among state newborn  
screening programs, including information on criteria considered 
in selecting disorders to include in state programs, education	 
for parents and providers about newborn screening programs, and  
programs' expenditures and funding sources. To collect this	 
information, GAO surveyed newborn screening programs for genetic 
and metabolic disorders in all 50 states and the District of	 
Columbia. GAO was also asked to provide information on efforts by
the Department of Health and Human Services (HHS) and states to  
evaluate the quality of newborn screening programs, state laws	 
and regulations that address parental consent for newborn	 
screening, and state laws and regulations that address		 
confidentiality issues. 					 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-03-449 					        
    ACCNO:   A06334						        
  TITLE:     Newborn Screening: Characteristics of State Programs     
     DATE:   03/17/2003 
  SUBJECT:   Disease detection or diagnosis			 
	     Federal/state relations				 
	     Health care programs				 
	     Health care services				 
	     Program evaluation 				 
	     Quality assurance					 
	     State-administered programs			 
	     Children						 
	     CDC Newborn Screening Quality Assurance		 
	     Program						 
                                                                 
	     HRSA Maternal and Child Health Services		 
	     Block Grant					 
                                                                 

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GAO-03-449

Report to Congressional Requesters

United States General Accounting Office

GAO

March 2003 NEWBORN SCREENING

Characteristics of State Programs

GAO- 03- 449

While the number of genetic and metabolic disorders included in state
newborn screening programs ranges from 4 to 36, most states screen for 8
or fewer disorders. In deciding which disorders to include, states
generally consider similar criteria, such as whether the disorder is
treatable. States also consider the cost of screening for additional
disorders. HHS*s Health

Resources and Services Administration is funding an expert group to assist
it in developing a recommended set of disorders for which all states
should screen and criteria for selecting disorders.

Most state newborn screening programs have similar practices for
administering and funding their programs. Almost all states provide
education on their newborn screening program for parents and providers,
but fewer than one- fourth inform parents of their option to obtain tests
for additional disorders not included in the state*s program. State
programs are primarily funded through fees collected from health care
providers, who may receive payments from Medicaid and other third- party
payers. Nationwide, fees funded 64 percent of states* 2001 fiscal year
program expenditures of over $120 million. All newborn screening
laboratories participate in a quality assurance program

offered by HHS*s Centers for Disease Control and Prevention, which assists
programs in evaluating the quality of their laboratories. All states
require newborn screening, and state statutes that govern screening
usually do not

require parental consent. However, 33 states* newborn screening statutes
or regulations allow exemptions from screening for religious reasons, and
13 additional states* newborn screening statutes or regulations allow
exemptions for any reason. Newborn screening statutes and regulations in
over half the states contain confidentiality provisions, but these
provisions are often subject to exceptions.

HHS said that the report presents a thorough summary of state newborn
screening programs* current practices.

Disorders Most States Included in Their Newborn Screening Programs as of
December 2002 Disorder Number of states a Phenylketonuria 51 Congenital
hypothyroidism 51 Galactosemia 50 Sickle cell diseases 44 Congenital
adrenal hyperplasia 32 Source: National Newborn Screening and Genetics
Resource Center.

Note: This table does not include states that provide screening for the
disorders to selected populations, as part of pilot programs, or by
request.

a *States* refers to the 50 states and the District of Columbia. Each year
state newborn screening programs test 4 million newborns

for disorders that require early detection and treatment to prevent
serious illness or death. GAO was asked to provide the Congress with
information on the variations among state newborn screening programs,
including information on criteria considered in selecting

disorders to include in state programs, education for parents and
providers about newborn screening programs, and programs* expenditures and
funding sources. To collect this information, GAO surveyed newborn
screening programs for genetic and metabolic

disorders in all 50 states and the District of Columbia. GAO was also
asked to provide information on efforts by the Department of Health and
Human Services (HHS) and states to evaluate the quality of newborn
screening programs, state

laws and regulations that address parental consent for newborn screening,
and state laws and regulations that address confidentiality issues.

www. gao. gov/ cgi- bin/ getrpt? GAO- 03- 449. To view the full report,
including the scope and methodology, click on the link above. For more
information, contact Marjorie Kanof at (202) 512- 7119. Highlights of GAO-
03- 449, a report to

Congressional Requesters

March 2003

NEWBORN SCREENING

Characteristics of State Programs

Page i GAO- 03- 449 State Newborn Screening Programs Letter 1 Results in
Brief 2 Background 4 Disorders Included in State Newborn Screening
Programs Vary,

but Administration of Program Components Is Similar 8 State Spending on
Newborn Screening Varies, and Majority of State Programs Receive Most
Funding from Fees 14 Newborn Screening Quality Assurance Efforts Focus on
Laboratory Testing and Performance Monitoring 17 States Generally Do Not
Require Consent for Newborn Screening and Most Limit Disclosure of
Screening Information 21 Agency Comments 26 Appendix I Scope and
Methodology 28

Appendix II Number of Disorders Included in State Newborn Screening
Programs, December 2002 31

Appendix III Information on Disorders Most Commonly Included in State
Newborn Screening Programs 33

Appendix IV Selected Disorders States Screen for Using MS/ MS and Number
of States That Screen for Each, December 2002 34

Appendix V State Newborn Screening Program Fees and Expenditures Per
Infant Screened 35

Appendix VI Comments from the Department of Health and Human Services 37
Contents

Page ii GAO- 03- 449 State Newborn Screening Programs Appendix VII GAO
Contact and Staff Acknowledgments 42

GAO Contact 42 Acknowledgments 42 Tables

Table 1: Disorders Most Commonly Included in State Newborn Screening
Programs, December 2002 9 Table 2: Categories of Individuals Represented
on States* Newborn

Screening Advisory Committees 12 Table 3: Number of States Notifying
Specific Parties of Newborn Screening Results 13 Table 4: Funding Sources
for State Newborn Screening Programs, as Percentage of Nationwide Program
Expenditures, State Fiscal Year 2001 16 Table 5: Basis on Which Newborn
Screening Exemption Is Granted, by State 22 Table 6: Exceptions to
Confidentiality Requirements in States* Genetic Privacy Laws 25

Page iii GAO- 03- 449 State Newborn Screening Programs Abbreviations

AAP American Academy of Pediatrics APHL Association of Public Health
Laboratories CDC Centers for Disease Control and Prevention CLIA Clinical
Laboratory Improvement Amendments of 1988 CMS Centers for Medicare &
Medicaid Services CORN Council of Regional Networks for Genetic Services
HHS Department of Health and Human Services HRSA Health Resources and
Services Administration MCAD medium- chain acyl- CoA dehydrogenase
deficiency MS/ MS tandem mass spectrometry NCSL National Conference of
State Legislatures

NIH National Institutes of Health NSQAP Newborn Screening Quality
Assurance Program PKU phenylketonuria

This is a work of the U. S. Government and is not subject to copyright
protection in the United States. It may be reproduced and distributed in
its entirety without further permission from GAO. It may contain
copyrighted graphics, images or other materials. Permission from the
copyright holder may be necessary should you wish to reproduce copyrighted
materials separately from GAO*s product.

Page 1 GAO- 03- 449 State Newborn Screening Programs

March 17, 2003 The Honorable Christopher J. Dodd The Honorable Mike DeWine
United States Senate

Each year newborn screening programs in all the states test 4 million
newborns to identify those who may have specific genetic and metabolic
disorders that could threaten their life or long- term health. 1 Early
detection, diagnosis, and treatment of these disorders may prevent a
child*s death, serious illness, or disability. For example, children with
the metabolic disorder phenylketonuria (commonly referred to as PKU)
cannot properly metabolize common foods, including milk and meat, and need
to be placed on a special diet to avoid mental retardation. Children with
sickle cell diseases, which are genetic blood disorders, can receive

antibiotic treatment to reduce the risk of bacterial infections. Newborn
screening is a state public health activity, with each state responsible
for designing and implementing its own program. For example, each state
decides which disorders to include in its screening program. To assist the
Congress as it considers actions related to newborn screening, you asked
us to provide information on the variations among state newborn screening
programs. In response to your request, this report provides information on
(1) the disorders tested for in each state; how disorders are selected,
including the use of advisory committees; and how states educate parents
and health care providers about newborn screening, notify them of
screening results, and follow up on abnormal results, (2) state newborn
screening programs* expenditures and funding sources, (3) efforts by the
Department of Health and Human Services (HHS) and states to monitor and
evaluate the quality of state newborn screening programs, and (4) how
state laws address consent and privacy issues related to newborn
screening. As you requested, this report focuses

only on newborn screening for genetic and metabolic disorders and does not
include information on screening programs for hearing and infectious
diseases.

1 In this report, *states* refers to the 50 states and the District of
Columbia.

United States General Accounting Office Washington, DC 20548

Page 2 GAO- 03- 449 State Newborn Screening Programs

To provide information on state newborn screening programs, we surveyed
state health officers in all the states during October and November 2002.
The survey collected information on the laboratory and program
administration/ follow- up components of states* newborn screening
programs, including their expenditures and funding sources. For the
purposes of the survey and this report, follow- up activities include
activities that are provided in response to abnormal screening results,
such as confirmation of diagnosis and referral for treatment. We did not
ask for information on disease management and treatment services. We spoke
with staff of several states* newborn screening programs to clarify survey
responses and to obtain additional, more detailed information. We also
reviewed information compiled by the National Newborn Screening and
Genetics Resource Center, a project funded by HHS*s Health Resources and
Services Administration (HRSA), which collects information on state
newborn screening programs. In addition, we reviewed documents and
interviewed Centers for Disease Control and Prevention (CDC) and HRSA
staff on their efforts to monitor and evaluate the quality of state
newborn screening programs. To determine how state

laws address consent and privacy issues related to newborn screening, we
analyzed state statutes and selected regulations that provide for newborn
screening for genetic and metabolic disorders, and state statutes that
relate to privacy of genetic information generally. To identify state
newborn screening statutes and regulations and state genetic privacy
statutes, we relied on research material provided by the National
Conference of State Legislatures. (For additional information on our scope
and methodology, see app. I.)

We conducted our work from June 2002 through March 2003 in accordance with
generally accepted government auditing standards. While the number of
genetic and metabolic disorders included in state newborn screening
programs ranges from 4 to 36, most states screen for 8 or fewer disorders.
Authority for deciding which disorders to include in programs often rests
with state health departments or boards of health, which generally receive
input from advisory committees. Screening for certain disorders may also
be mandated by state law. In deciding which disorders to include in their
programs, states generally consider similar criteria, such as how often
the disorder occurs in the population, whether an effective screening test
exists, and whether the disorder is treatable. States also reported that
they consider the cost of screening for additional

disorders, which may include costs associated with performing more tests,
acquiring and implementing new technology, and following up on Results in
Brief

Page 3 GAO- 03- 449 State Newborn Screening Programs

abnormal results. With the exception of federal recommendations that
newborns be screened for PKU, congenital hypothyroidism, and sickle cell
diseases, there are no federal guidelines on the set of disorders that
should be included in state screening programs. HRSA is funding an expert
group to assist it in developing a recommended set of disorders for which
all states should screen and criteria for selecting disorders. Almost all
states provide education on their screening program for parents and
providers. However, fewer than one- fourth of the states inform parents of
their option to obtain testing for additional genetic and metabolic
disorders not included in the state*s program. All state programs notify a
health care provider, such as a physician or hospital, of abnormal newborn
screening results; fewer than half routinely notify parents directly of
abnormal results. All states also follow up on abnormal results; their
follow- up activities may include obtaining additional laboratory
information, referring the infant for treatment, or confirming that
treatment has begun. States spent over $120 million on newborn screening
in their 2001 fiscal year, with most states spending from $20 to $40 for
each infant screened.

Most of these expenditures supported the laboratory component of screening
programs, including the processing and analysis of specimens. Nationwide,
newborn screening fees funded 64 percent of programs* expenditures. The
fees are generally paid by the health care providers submitting specimens,
who in turn may receive payments from Medicaid and other third- party
payers, including private insurers. Other funding sources included HRSA*s
Maternal and Child Health Services Block Grant, direct payments from
Medicaid, and other state and federal funds.

CDC and HRSA offer services to help states monitor and evaluate the
quality of their newborn screening programs. All laboratories that perform
testing for state newborn screening programs voluntarily participate in
CDC*s Newborn Screening Quality Assurance Program (NSQAP). This

enables them to meet the federal regulatory requirement under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) to have a process for
verifying the accuracy of tests they perform. HRSA*s National Newborn
Screening and Genetics Resource Center conducts technical reviews of
individual state newborn screening programs that request them; the
Resource Center has conducted nine reviews since January 2000. These
reviews respond to specific questions raised by state officials, such as
how to implement an expansion of the state*s program. The reviewing team
also analyzes the overall state newborn screening program and provides

the state with findings and recommendations that could improve the
program. States are not obligated to implement these recommendations. In
addition to participating in federal quality assurance programs, most
state

Page 4 GAO- 03- 449 State Newborn Screening Programs

newborn screening programs reported that they evaluate the quality of the
laboratory testing or program administration/ follow- up components of
their programs.

State newborn screening statutes usually do not require that parental
consent be obtained before screening occurs. While all states require
newborn screening, 33 states* newborn screening statutes or regulations
allow exemptions from screening for religious reasons, and 13 additional
states* newborn screening statutes or regulations allow exemptions for any
reason. Newborn screening statutes and regulations in over half the states
specify that newborn screening information is confidential, but these
confidentiality provisions are often subject to exceptions, which vary
across states. The most common exception allows disclosure of information
for research purposes, provided that the child*s identity is not revealed
and researchers comply with applicable laws for the protection of humans
in research activities. Other exceptions include use of information for
law enforcement and for establishing paternity. Over half the states have
statutes that govern the collection, use, or disclosure of

genetic information, which may also apply to genetic information obtained
from newborn screening. While few newborn screening statutes provide
penalties for violation of confidentiality provisions, 17 states* genetic
privacy statutes provide specific penalties for violating genetic privacy

laws. In commenting on a draft of this report, HHS said that the report
presents a thorough summary of state newborn screening programs* current
practices.

Newborn screening programs in the United States began in the early 1960s
with the development of a screening test for PKU and a system for
collecting and transporting blood specimens on filter paper. All newborn
screening begins with a health care provider collecting a blood specimen
during a newborn*s first few days of life. 2 The baby*s heel is pricked to
obtain a few drops of blood, which are placed on a specimen collection
card and sent to a laboratory for analysis. State departments of health
may

2 All states have screening statutes or regulations that specify certain
health care providers who are responsible for ensuring that newborns are
screened, such as the attending physician, nurse, midwife, hospital, or
other institution caring for the infant. Some state screening statutes and
regulations include a child*s parent among those who are responsible for
ensuring that screening occurs. Background

Page 5 GAO- 03- 449 State Newborn Screening Programs

use their own laboratory to test samples from the dried blood spots or may
have a contract with a private laboratory, a laboratory at a university
medical school, or another state*s public laboratory.

Laboratories may choose among a variety of testing methods to maximize the
efficiency and effectiveness of their testing. A major technical advance
in newborn screening is use of the tandem mass spectrometer, an analytical
instrument that can precisely measure small amounts of material and enable
detection of multiple disorders from a single analysis of a blood sample.
Tandem mass spectrometry (MS/ MS) has greatly increased the number of
disorders that can be detected, but it cannot completely replace other
analysis methods because it cannot screen for all disorders included in
state newborn screening programs.

After initial testing, state newborn screening program staff notify health
care providers of abnormal results because it may be necessary to verify
the accuracy of the initial screening result by testing a sample from a
second specimen or to ensure that the infant receives more extensive
diagnostic testing to confirm the presence of a disorder. The infant may
also need immediate treatment. Laboratories and state maternal and child

health programs generally carry out the notification process. Primary care
and specialty physicians are involved in various stages of the newborn
screening process. They generally are responsible for notifying the family
of abnormal screening results and may confirm initial results through
additional testing. If necessary, they identify appropriate management and
treatment options for the child. State maternal and child health program
staff may follow up to ensure that these activities occur.

Several HHS agencies carry out activities related to newborn screening,
including collecting and sharing information about state newborn screening
programs, promoting quality assurance, and funding screening services.
HRSA*s Maternal and Child Health Bureau has primary responsibility for
promoting and improving the health of infants and mothers. HRSA offers
grants to states, including the Maternal and Child Health Services Block
Grant, that state newborn screening programs may use to support their
newborn screening services. HRSA also funded the development of the
Council of Regional Networks for Genetic Services (CORN) in 1985 to
provide a forum for information exchange among groups concerned with
public health aspects of genetic services. The newborn screening committee
of CORN identified several areas of importance to programs, including the
process of selecting disorders for Federal Role in Newborn

Screening

Page 6 GAO- 03- 449 State Newborn Screening Programs

screening, communication, quality assurance, and funding. It developed
guidelines in these areas to increase consistency among state newborn
screening programs 3 and also began collecting data on state programs. In
1999, CORN was disbanded, and HRSA established the National Newborn
Screening and Genetics Resource Center* the Resource Center. The Resource
Center is supported by a cooperative agreement between the Genetic
Services Branch of HRSA*s Maternal and Child Health Bureau and the
University of Texas Health Science Center at San Antonio Department of
Pediatrics. The Resource Center develops annual reports on state newborn
screening activities and provides technical assistance to state newborn
screening programs. It also provides information and educational resources
to health professionals, consumers, and the public health community.

CDC*s Newborn Screening Branch, 4 in partnership with the Association of
Public Health Laboratories (APHL), operates NSQAP. 5 NSQAP is a voluntary,
nonregulatory program that is designed to help state health departments
and their laboratories maintain and enhance the quality of their newborn
screening test results. In addition, CDC*s National Center

on Birth Defects and Developmental Disabilities funds research related to
newborn screening. The Centers for Medicare & Medicaid Services* (CMS)
involvement in newborn screening relates to its Medicaid and CLIA
programs. CMS administers Medicaid, a jointly funded, federal- state
health insurance program for certain low- income individuals, which covers
newborn screening for eligible infants. Nationwide, Medicaid finances
services for one in three births each year. Through the CLIA program, 6
CMS also

3 Council of Regional Networks for Genetic Services, *U. S. Newborn
Screening System Guidelines: Statement of the Council of Regional Networks
for Genetic Services,*

Screening, vol. 1 (1992). Additional CORN guidelines were published in
2000; see Council of Regional Networks for Genetic Services, *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,* Supplement to The Journal of Pediatrics, vol.

137, no. 4 (2000). 4 The Newborn Screening Branch is in the National
Center for Environmental Health*s Department of Laboratory Services. 5
NSQAP has a memorandum of understanding with APHL. APHL provides
assistance to NSQAP on how the program operates, including input on how to
report data and which disorders to include in NSQAP.

6 Pub. L. No. 100- 578 S: 2, 102 Stat. 2903, 2907.

Page 7 GAO- 03- 449 State Newborn Screening Programs

regulates laboratory testing performed on specimens obtained from humans,
including the dried blood spots used for newborn screening. CLIA*s purpose
is to ensure the accuracy, reliability, and timeliness of

laboratory test results. CLIA requires that laboratories comply with
quality requirements in five major areas: personnel qualifications and
responsibilities, quality control, patient test management, quality
assurance, and proficiency testing. 7 Laboratories that fail to meet
CLIA*s quality requirements are subject to sanctions, including denial of
Medicaid payments. 8 Through the CLIA program, laboratories that test
dried blood

spots in connection with newborn screening must have a process for
verifying the accuracy of their tests at least two times each year. State
newborn screening laboratories can meet this requirement through
participation in the proficiency testing program offered by NSQAP.

The National Institutes of Health*s (NIH) National Institute of Child
Health and Human Development has sponsored research on disorders
identified through newborn screening, including PKU, congenital
hypothyroidism, and galactosemia. Research has addressed issues such as
the effectiveness of screening and treatments and the application of new
technologies for identifying additional disorders.

The Children*s Health Act of 2000 authorized HHS to award grants to
improve or expand the ability of states and localities to provide
screening, counseling, or health care services for newborns and children
who have, or are at risk for, heritable disorders and to evaluate the
effectiveness of these services. 9 As of February 2003, funds had not been
appropriated to fund these grants. The act also authorized the
establishment of a committee to advise the Secretary of HHS on reducing
the mortality and morbidity of newborns born with disorders. The Secretary
of HHS signed the charter for this committee in February 2003. Under the
Health Insurance Portability and Accountability Act of 1996, 10 HHS
developed regulations to protect the privacy of health information,

7 Proficiency testing is the process of sending sample specimens to
laboratories to verify the accuracy and reliability of their tests. 8 This
could also result in denial of Medicare payments.

9 Pub. L. No. 106- 310, S: 2601, 114 Stat. 1101, 1164. 10 Pub. L. No. 104-
191 S: 264, 110 Stat. 1939, 2033- 2034. Federal Privacy Standards

Page 8 GAO- 03- 449 State Newborn Screening Programs

which as defined in the regulations, would include the results of testing
of newborns. The regulations give individuals the right, in most cases, to
inspect and obtain copies of health information about themselves. In
addition, the regulations generally restrict health plans and certain
health care providers from disclosing such information to others without
the patient*s consent, except for purposes of treatment, payment, or
healthcare operations. 11 While the federal regulations preempt state
requirements that conflict with them, states are free to enact and enforce
more stringent privacy protections. Most entities and individuals that are

covered by the regulations must be in compliance by April 14, 2003.
Although state newborn screening programs vary in the number of disorders
for which they screen, states generally follow similar practices and
criteria in selecting disorders for their programs. States also conduct
most other aspects of their programs in similar ways. Almost all state
programs provide information for parents and conduct provider education,
but fewer than one- fourth of the states provide information for parents
on their option to test for additional disorders not included in the
state*s program. All state programs notify health care providers* and some
also notify parents* about abnormal screening results, and all states
reported following up on abnormal results.

Most state newborn screening programs screen for 8 disorders or fewer. The
number of disorders included in state programs ranges from 4 to 36. (See
app. II for the number of disorders screened for by each state.) Programs
are implemented through state statutes and/ or regulations, which often
require screening for certain disorders. According to the Resource Center,
all states require screening for PKU and congenital hypothyroidism, and 50
states require screening for galactosemia. Table 1 lists the disorders
most commonly included in state newborn screening programs. (See app. III
for information on these disorders.) Some states provide screening for
certain disorders to selected populations, through pilot programs, or by
request. For example, in addition to the 44 states that require screening
for sickle cell diseases for all newborns, 6 states provide screening for
sickle cell diseases to selected populations or through pilot 11 There are
additional exceptions to facilitate compliance with state reporting
requirements

and other public health purposes. Disorders Included in

State Newborn Screening Programs Vary, but Administration of Program
Components Is Similar

Most States Screen for Eight Disorders or Fewer

Page 9 GAO- 03- 449 State Newborn Screening Programs

programs. Some states are taking steps that could expand the number of
disorders included in their programs. 12 Table 1: Disorders Most Commonly
Included in State Newborn Screening

Programs, December 2002 Disorder Number of states a

PKU 51 Congenital hypothyroidism 51 Galactosemia 50 Sickle cell diseases
44 Congenital adrenal hyperplasia 32 Biotinidase deficiency 24 Maple syrup
urine disease 24 Homocystinuria 17

Source: National Newborn Screening and Genetics Resource Center. Note:
This table does not include states that provide screening for the
disorders to selected populations, as part of pilot programs, or by
request. a *States* refers to the 50 states and the District of Columbia.

The criteria that state newborn screening programs reported they consider
in selecting disorders to include in their programs are generally
consistent across states. For example, they generally include how often
the disorder

occurs in the population, whether an effective screening test exists to
identify the disorder, and whether the disorder is treatable. These
criteria are also consistent with recommendations of the American Academy
of

Pediatrics (AAP) newborn screening task force. 13 Neither the criteria
states use nor AAP*s recommendations include benchmarks, such as the
lowest 12 For example, Connecticut, which screens for 8 disorders, plans
to add 3 disorders to its program in March 2003 and is considering adding
others. Mississippi, which screens for 5 disorders, is in the process of
reviewing proposals from laboratories to conduct screening for 35
additional disorders. Virginia, which screens for 8 disorders, has added
mediumchain

acyl- CoA dehydrogenase deficiency (MCAD) to the state*s newborn screening
program, contingent on the program*s acquiring funding to support follow-
up staff and the purchase of necessary equipment. Children with MCAD
cannot convert fat to energy, and

must avoid fasting, which might occur when the child is ill. To avoid risk
of seizures, brain damage, or death, these children must either continue
eating while ill or receive nutrients under medical supervision.

13 American Academy of Pediatrics Newborn Screening Task Force, *Serving
the Family From Birth to the Medical Home: Newborn Screening: A Blueprint
for the Future* A Call for a National Agenda on State Newborn Screening
Programs,* Pediatrics, vol. 106, no. 2 (2000). HRSA funded the task force.

Page 10 GAO- 03- 449 State Newborn Screening Programs

incidence or prevalence rate that would be acceptable for populationbased
newborn screening or measurements of treatment effectiveness or screening
reliability.

Some states reported that they are considering revising their criteria
because MS/ MS can identify disorders for which treatment is not currently
available. Because MS/ MS technology can be used for screening multiple
disorders in a single analysis, states may choose to include such
disorders in their testing along with disorders that can be treated. 14
Twenty- one states use MS/ MS in their screening programs (see app. II);
15 the number of disorders for which screening is conducted using MS/ MS
ranges from 1 to 28. (See app. IV for a list of selected disorders for
which screening is conducted using MS/ MS.)

Many states consider cost when selecting disorders to include in their
newborn screening program. In addition, several states told us that they
would need additional funding to expand the number of disorders in their
program. The costs associated with adding disorders include costs of
additional testing, educating parents and providers, and following up on
abnormal results. Additional costs may also be associated with acquiring
and implementing new technology, such as purchasing MS/ MS technology and
training staff in its use.

With the exception of federal recommendations that newborns be screened
for three specific disorders, there are no federal guidelines on the set
of disorders that should be included in state screening programs. The U.
S. Preventive Services Task Force, which is supported by HHS*s Agency for
Healthcare Research and Quality, has recommended screening for sickle cell
diseases, PKU, and congenital hypothyroidism. In addition, NIH issued a
consensus statement recommending that all newborns be screened for sickle
cell diseases, as well as a consensus statement concluding that genetic
testing for PKU has been very successful in the prevention of severe
mental retardation. 16 AAP*s newborn screening task

14 There has been discussion among experts about the appropriate use of
MS/ MS in newborn screening. This has focused on several issues, including
whether the incidence and severity of the disorders detected by MS/ MS
justifies screening and whether effective

treatment would be available for disorders detected. 15 Twelve additional
states reported they plan to begin using MS/ MS by the end of 2003.

16 NIH consensus statements are prepared by a nonfederal panel of experts
and reflect the panel*s assessment of medical knowledge available at the
time the statement is written.

Page 11 GAO- 03- 449 State Newborn Screening Programs

force reported that infants born anywhere in the U. S. should have access
to screening tests and procedures that meet accepted national standards
and guidelines. The task force recommended that federal and state public
health agencies, in partnership with health professionals and consumers,
develop and disseminate model state regulations to guide implementation of
state newborn screening systems, including the development of criteria for
selecting disorders. In 2001, HRSA awarded a contract to the American

College of Medical Genetics to convene an expert group to assist it in
developing a recommended set of disorders for which all states should
screen and criteria that states should consider when adding to or revising
the disorders in their newborn screening programs. 17 The expert group is
expected to make recommendations to HRSA in spring 2004. Some state
officials told us they have concerns about the development of a uniform
set of disorders because states differ in incidence rates for disorders
and capacity for providing follow- up and treatment.

Most states reported that the state health department or board of health
has authority to select the disorders included in newborn screening
programs. Six states reported that they could not modify the disorders
included in their newborn screening programs without legislation.
Fortyfive states reported that they have an advisory committee that is
involved in selecting disorders; such a committee generally makes
recommendations to the state health department or board of health. Most
states reported that their advisory committee is not required by state
statute or regulation. We found that most newborn screening advisory
committees are multidisciplinary and include physicians, other health
workers, and individuals with disorders or parents of children with
disorders. (See table 2.)

17 The expert group is also charged with recommending minimum standards
for state newborn screening programs to use in assessing and evaluating
their programs, and with recommending health outcomes that would be
appropriate to use in monitoring and evaluating newborn screening. In
addition, it is to consider the value of establishing a national process
for the evaluation and oversight of newborn screening programs.

Page 12 GAO- 03- 449 State Newborn Screening Programs

Table 2: Categories of Individuals Represented on States* Newborn
Screening Advisory Committees

Category Number of states a

Specialty medical care physicians b 44 Laboratory specialists 41
Pediatricians and/ or other primary health care providers 40 Health
department staff who conduct follow- up activities 38 Individuals with
disorders or parents of children with disorders 35 Ethicists 16 Other c 28

Source: GAO Survey of State Newborn Screening Programs for Genetic and
Metabolic Disorders, October 21, 2002. a Forty- four states and the
District of Columbia reported that they have an advisory committee.

b Includes metabolic specialists, endocrinologists, geneticists, and
hematologists. c Includes representatives from state hospital
associations, state March of Dimes chapters, social workers, lawyers,
other state and local health department staff, dieticians, and state
legislators.

Almost all states reported they offer information for parents and
education for providers on their newborn screening program. Eleven states
have newborn screening statutes requiring that parents of newborns be

informed of the program at the time of screening. 18 In most states,
information for parents includes how the blood specimen is obtained, the
disorders included in the state program, and how parents will be notified
of testing results. Seven states reported they include information for
parents on their option to obtain testing for additional disorders that
are not included in the state*s program, but that may be available to them
through other laboratories. 19 Provider education offered by states
includes information on the collection and submission of specimens, the
management of the disorders, and medical specialists available to treat
the disorders.

18 The 11 states are California, the District of Columbia, Delaware,
Maryland, Missouri, Nebraska, New Mexico, Oregon, Vermont, Wisconsin, and
Wyoming. Some of these state statutes require that specific information be
provided to parents, such as the purpose of the screening and the risks
involved. Other statutes do not specify the type of information that
should be communicated to parents. 19 Five of these states and five
additional states reported that they communicate information

to health care providers on parents* option to obtain testing for
additional disorders that are not included in the state*s program. Most
States Provide Information for Parents

and Conduct Provider Education, but Few Provide Information to Parents on
Screening Not Included in State Program

Page 13 GAO- 03- 449 State Newborn Screening Programs

While state newborn screening programs produce or compile materials for
parents, they generally do not provide them directly to parents and are
unable to say when, or if, parents actually receive them. Rather, the
state provides materials to other individuals, including hospital staff,
midwives, pediatricians, primary care providers, and local health
department staff, who are expected to share them with parents. Over half
the states reported that their materials for parents are available in
English and one or more other languages.

The parties states notify about newborn screening results vary, depending
on whether the result is abnormal 20 or normal. (See table 3.) All states
reported that for abnormal results, they notify the physician of record or
the birth or submitting hospital. The physician or hospital, in turn, is
generally responsible for notifying parents. Most states reported they
notify physicians and hospitals by telephone; many states reported also
notifying them by letter, fax, or E- mail. While the AAP newborn screening
task force recommended that programs notify parents or guardians, fewer
than half the states routinely notify parents directly of abnormal
results, and no state routinely notifies parents directly of normal
results. States that notify parents generally said that notification of
parents was by letter. Table 3: Number of States Notifying Specific
Parties of Newborn Screening Results

Number of states Party notified Abnormal results Normal results

Birth or submitting hospital 50 49 Physician of record 51 34 Specialty
provider 34 a Parent 22 0 Other b 16 7

Source: GAO Survey of State Newborn Screening Programs for Genetic and
Metabolic Disorders, October 21, 2002. a *States* refers to the 50 states
and the District of Columbia. b Because specialty care is not necessary
for children with normal results, we did not ask states if a

specialty provider was notified. c Includes midwives, county and local
health departments, and the infant*s primary care physician.

20 There are two types of abnormal results. Those that are strongly
positive require the newborn to immediately receive diagnostic tests or
treatment. Those for which the reliability of the result is questionable
require testing of a sample from a second specimen, which is less time-
critical. States Generally Notify Multiple Parties of

Abnormal and Normal Screening Results and Follow Up on Abnormal Results

Page 14 GAO- 03- 449 State Newborn Screening Programs

States also reported that they take other actions in response to abnormal
screening results. About three- fourths of states reported testing samples
from second specimens when the initial specimen is abnormal or
unsatisfactory. 21 All states reported conducting follow- up activities.
Over 90 percent of states said that their follow- up activities include
obtaining additional laboratory information to confirm the presence of a
disorder, which could include obtaining the results of diagnostic tests
performed by other laboratories. Almost all states reported that they
refer infants with disorders for treatment and most follow up to confirm
that treatment has begun. About two- thirds of the states reported that
they conduct or fund periodic follow- up of newborns diagnosed with a
disorder, which could include ensuring that they continue to receive
treatment and monitoring their health status. According to Resource Center
data on state newborn screening programs, the length of the follow- up
period varies among disorders and across states. 22 States reported that
they spent over $120 million on newborn screening in

state fiscal year 2001, with individual states* expenditures ranging from
$87,000 to about $27 million. Seventy- four percent of these expenditures
supported laboratory activities. The primary funding source for most
states* newborn screening expenditures was newborn screening fees. The
fees are generally paid by health care providers submitting specimens;

they in turn may receive payments from Medicaid and other third- party
payers, including private insurers. Other funding sources that states
identified included the Maternal and Child Health Services Block Grant,
direct payments from Medicaid, and other state and federal funds.

21 One state reported that testing samples from second specimens is
required if the first specimen is collected before the newborn is 48 hours
old, regardless of whether the initial test result was normal or abnormal.
Thirteen states reported testing samples from second specimens for all
newborns for all tests included in the initial screen.

22 National Newborn Screening and Genetics Resource Center, National
Newborn Screening Report - 1999, (Austin, Tex.: July 2002). State Spending
on

Newborn Screening Varies, and Majority of State Programs Receive Most
Funding from Fees

Page 15 GAO- 03- 449 State Newborn Screening Programs

States reported they spent over $120 million on laboratory and program
administration/ follow- up activities in state fiscal year 2001. 23 , 24
Individual states* expenditures ranged from $87,000 to about $27 million.
Based on information provided by 46 states, we found that, on average,
states spent $29.44 for each infant screened in state fiscal year 2001. 25
Two- thirds of these states spent from $20 to $40 per infant. (See app. V
for expenditures per infant screened in each state.)

Laboratory expenditures accounted for 74 percent of states* expenditures;
program administration/ follow- up expenditures accounted for 26 percent.
26 States reported that laboratory expenditures generally supported
activities

such as processing and analyzing specimens, notifying health care
providers and parents of screening test results, and evaluating the
quality of laboratory activities. Program administration/ follow- up
expenditures generally supported activities such as notifying appropriate
parties of test results, confirming that infants received additional
laboratory testing, confirming that infants diagnosed with disorders
received treatment, and providing education to parents and health care
providers. In addition, almost half the states reported that laboratory
expenditures supported education of parents and health care providers.

23 We asked states to provide us expenditure information for laboratory
and program administration/ follow- up; we instructed states to include
only those follow- up activities that are conducted through confirmation
of diagnosis and referral for treatment. We did not ask for expenditure
information for disease management and treatment services.

24 Expenditure calculations were based on responses from 50 states; South
Dakota reported that expenditure information was not available for state
fiscal year 2001. Six states reported that their expenditures included
significant, nonrecurring expenses in state fiscal year 2001, such as for
the purchase of MS/ MS equipment or computer software. These expenditures
ranged from $22, 645 to $415,835, totaling about $1 million. In addition,
one state told us that the program administration/ follow- up expenditures
it reported included approximately $50,000 to $75,000 for disease
management and treatment services.

25 We were unable to calculate expenditures per infant screened for five
states. South Dakota reported that expenditure information was not
available for state fiscal year 2001. Florida, Georgia, Kentucky, and
Minnesota did not provide information on the number of infants screened.
26 Expenditure calculations are based on responses from 49 states. South
Dakota reported

that expenditure information was not available for state fiscal year 2001.
New York provided total expenditure information but did not separately
identify expenditures for the laboratory and program administration/
follow- up components. Newborn Screening

Expenditures Vary by State

Page 16 GAO- 03- 449 State Newborn Screening Programs

Fees are the largest funding source for most states* newborn screening
programs. Forty- three states reported they charge a newborn screening fee
to support all or part of program expenditures. 27 The fees are generally
paid by health care providers submitting specimens; they in turn may
receive payments from Medicaid and other third- party payers, including
private insurers. Some states collect the fees through the sale of
specimen collection kits to hospitals and birthing centers. Other states
may bill hospitals, patients, physicians, Medicaid, or other third- party
payers for the fee. Nationwide, newborn screening fees funded 64 percent
of newborn screening program expenditures in state fiscal year 2001. 28 ,
29 (See table 4.) Thirteen state programs reported that fees were their
sole source of funding in fiscal year 2001, and 19 additional states
reported that fees funded at least 60 percent of their newborn screening
expenditures. The average fee in the states that charged a fee was about
$31, with fees ranging from $10 to $60.

Table 4: Funding Sources for State Newborn Screening Programs, as
Percentage of Nationwide Program Expenditures, State Fiscal Year 2001

Funding source Percentage of program expenditures

Fees 64 Maternal and Child Health Services Block Grant 5 Medicaid a 10
Other state funds 19 Other funds b 2

Source: GAO Survey of State Newborn Screening Programs for Genetic and
Metabolic Disorders, October 21, 2002. Note: This table includes
information for 50 states; South Dakota reported that information on state
fiscal year 2001 funding sources was not available. We asked states to
provide us expenditure information for laboratory and program
administration/ follow- up components and instructed them to include only
those follow- up activities that are conducted through confirmation of
diagnosis and referral for treatment. We did not ask for expenditure
information for disease management and treatment services. a Includes
federal and state contributions.

b Includes, for example, the Preventive Health and Health Services Block
Grant.

27 We asked states to report whether they currently charge a fee, and if
so, the amount of that fee. States responded to the survey in October and
November 2002. 28 States may have also used fees to support disease
management and treatment activities. 29 South Dakota is not included in
any of the calculations related to funding sources; it reported that
information on state fiscal year 2001 funding sources was not available.
State Newborn Screening

Programs Are Funded Primarily through Fees

Page 17 GAO- 03- 449 State Newborn Screening Programs

Seven state newborn screening programs identified Medicaid as a direct
funding source in state fiscal year 2001. These screening programs bill
the state Medicaid agency directly for laboratory services or receive a
transfer of funds from the state Medicaid agency for screening services
provided to

Medicaid- enrolled infants. The percentage of expenditures the states
reported as directly funded by Medicaid does not include Medicaid payments
to hospitals for services provided to newborns. 30 Other funding sources
that states identified for newborn screening

program expenditures include state funds and the Maternal and Child Health
Services Block Grant. About half the states reported that state funds
supported laboratory or program administration/ follow- up expenditures.
In addition, about half the states reported that they rely on the Maternal
and Child Health Services Block Grant as a funding source for laboratory
or program administration/ follow- up expenditures. Seven states
identified other funding sources, such as the Preventive Health and Health
Services Block Grant.

CDC and HRSA offer services to assist states in evaluating the quality of
their newborn screening programs. For example, CDC*s NSQAP provides
proficiency testing for almost all disorders included in state newborn
screening programs, enabling states to meet the CLIA regulatory
requirement that laboratories have a process for verifying the accuracy of
tests they perform. Through the Resource Center, HRSA supports

technical reviews of state newborn screening programs. These voluntary
programwide reviews are conducted at the request of state health officials
and focus primarily on areas of concern identified by state officials. In
addition to these federally supported efforts, most state newborn
screening programs reported that they evaluate the quality of the
laboratory testing and/ or program administration/ follow- up components
of their newborn screening programs.

30 Medicaid may reimburse hospitals for newborn screening services on a
fee- for- service basis or as part of a maternity care package. Newborn
Screening Quality Assurance

Efforts Focus on Laboratory Testing and Performance Monitoring

Page 18 GAO- 03- 449 State Newborn Screening Programs

CDC*s NSQAP is the only program in the country that conducts proficiency
testing on the dried blood spots used in newborn screening. 31 While NSQAP
is voluntary, as of January 2003, all laboratories that perform testing
for state newborn screening programs participated in the proficiency
testing program. Participation in NSQAP allows laboratories to meet the
CLIA regulatory requirement that they have a process for verifying the
accuracy of tests they perform. NSQAP offers proficiency testing for over
30 disorders, including the disorders most commonly included in state
newborn screening programs.

When a laboratory misclassifies a specimen during proficiency testing,
NSQAP notifies the laboratory of the problem. When an abnormal specimen is
classified as normal, NSQAP officials work with the laboratory to identify
and solve the problem that led to the misclassification. NSQAP provides
information on the specimen that was misclassified, gives supplemental
specimens to the laboratory to test, and may visit the laboratory, if
necessary, to provide additional assistance. 32 In addition to proficiency
testing, NSQAP provides other types of quality

assurance assistance, including training, guidelines, and consultation to
laboratories that participate in the program. For example, in September
2001, NSQAP cosponsored a meeting of laboratory and medical scientists to
discuss issues related to the use of MS/ MS in newborn screening. 33 In
addition, NSQAP provides state newborn screening programs with quality
control specimens* test specimens designed to be run over a period of time
to ensure the stability of the testing methods* and works with the
manufacturers of the filter papers used in the collection of dried blood

31 To conduct proficiency testing, NSQAP prepares and distributes
specimens quarterly to participating laboratories. NSQAP does not include
information on the expected results with these specimens. Laboratories
analyze samples from the specimens and return their

analytical results and clinical assessments to NSQAP for review. NSQAP
compares the laboratory*s results to the expected results for the
specimen. All laboratories receive at least two abnormal specimens for
each disorder for which they test during the course of the year. These
proficiency testing services are provided at no charge to laboratories.

32 According to NSQAP officials, when a laboratory misclassifies a normal
specimen as abnormal, they inform the laboratory of the misclassification,
but do not offer additional assistance. This misclassification is not
considered a serious problem because the additional laboratory testing
that should follow an abnormal screening result would confirm that the
newborn does not have the disorder.

33 NSQAP cosponsored this meeting with HRSA, APHL, and the Wisconsin
Department of Health. CDC Provides Proficiency

Testing and Other Quality Assurance Services to Newborn Screening
Laboratories

Page 19 GAO- 03- 449 State Newborn Screening Programs

spots to ensure their quality. 34 NSQAP also publishes quarterly and
annual reports on the aggregate performance of participating laboratories.
These reports include information on the results of the proficiency
testing program. The annual reports also include information on NSQAP*s
quality control effort and describe other activities undertaken during the
year.

HRSA*s Resource Center offers technical reviews to states at their request
to help them refine and improve their newborn screening activities. 35 The
team that visits the state program typically includes a representative of
the Resource Center, a representative from CDC*s NSQAP to focus on
laboratory quality assurance, a health care provider to focus on medical
and genetic issues, a follow- up coordinator from another state program to
focus on the follow- up component of the program, and a representative
from HRSA to focus on financial and administrative issues. The Resource
Center*s reviews concentrate primarily on areas state officials ask the
team to review. For example, states have asked the review team to look at
whether or how the set of disorders included in their programs should be
expanded, how to incorporate MS/ MS into a program, and whether current
program staffing levels are appropriate. The review team also assesses the

degree to which the state program follows the 1992 CORN guidelines in
areas such as public, professional, and patient education, laboratory
proficiency testing, and consumer representation on advisory committees.

After reviewing a state newborn screening program, the team provides the
state with a final report that includes its findings and recommendations
to improve the program. Recent findings have included newborn screening
advisory committees that were not sufficiently multidisciplinary and
programs that did not have a systemwide quality assurance program. Review
teams have also identified the need for additional program administration/
follow- up staff and for provider education programs to

include information on collecting and submitting specimens and reporting
screening results. The state newborn screening program is not obligated to
accept or implement the team*s recommendations, and HRSA and the Resource
Center have no authority to require states to make changes to their
program. However, according to the Resource Center, most participating
states have made some modifications to their program in

34 The manufacturers of the filter paper voluntarily send statistically
valid sample sets of production lots for evaluation against specific NSQAP
criteria. 35 Prior to 1999, HRSA contracted with an expert panel to
conduct these reviews. HRSA Funds Voluntary

Technical Reviews of State Newborn Screening Programs

Page 20 GAO- 03- 449 State Newborn Screening Programs

response to recommendations. State officials told us, for example, that
they have expanded or diversified the membership of their advisory
committees, revised practitioner manuals, developed a programwide quality
assurance system, and hired additional program administration/ follow- up
staff. In addition, state newborn screening program staff told us that the
recommendations of the review teams helped inform program staff, state
legislators, and health department staff as they assessed program needs.

HRSA has funded 26 technical reviews in 22 states since the program began
in 1987; 36 9 of these reviews have occurred since January 2000. Every
state that has requested a review has been able to receive one.

Most states reported evaluating the quality of the laboratory testing and/
or program administration/ follow- up components of their newborn
screening programs. For example, laboratories monitor performance by
defining criteria for achieving quality results and designing a monitoring
program to evaluate whether they are meeting these criteria. One state
told us that it has criteria related to calibration of equipment,
personnel training and

education, and recordkeeping and documentation. Other measures that
programs may monitor include percentage of births screened, number of
unusable specimens, demographic information missing from specimen
collection cards, and number of children lost to follow- up. Several state
officials told us that they use some of these measures to monitor quality
of specimens received from hospitals and to identify hospitals that may
need

education regarding the newborn screening process. In addition, states
voluntarily report many of these measures to the Resource Center for
inclusion in its annual National Newborn Screening Report, enabling states
to compare their program over time with other states* programs. Moreover,
all states report annually to HRSA on the percentage of newborns in the
state who are screened for selected disorders, including PKU and
congenital hypothyroidism, as part of the Maternal and Child

Health Services Block Grant reporting requirements. 37 36 Four states
requested a second review several years after receiving the first review.
In addition to these 22 states, Guam and Saipan have also participated in
the program. 37 In addition, some states have developed other performance
measures related to newborn screening, which they submit to HRSA as part
of their Maternal and Child Health Services Block Grant annual report. For
example, one state reports on the percentage of newborns with abnormal
screening results who receive follow- up. Most State Newborn

Screening Programs Reported Evaluating Laboratory or Program
Administration/ Follow- up Activities

Page 21 GAO- 03- 449 State Newborn Screening Programs

About half the states reported to us that they have a mechanism for
learning of abnormal cases that were misclassified as normal, information
that can alert a state to problems with its program. According to experts
in the field of newborn screening, these cases occur infrequently but can
have serious results when children develop a life- threatening condition
that might have been prevented if treated early. Most of these states
learn about these cases through their communications with the specialists
in their state who manage and treat the disorders identified by newborn
screening. If a child is referred to one of these specialists from a
source other than the newborn screening program, the specialist will
usually contact program officials, who then determine whether the
screening program misclassified the child*s screening result as normal.
Four states reported that they can learn of abnormal cases misclassified
as normal through reports made to state birth defects or disease
registries. For example, one state reported that staff at the state birth
defects registry notify the newborn screening program of children reported
to them, and the newborn screening program then checks whether or not
these children were identified through the screening process.

State newborn screening statutes usually do not require that parental
consent be obtained before screening occurs. However, most state newborn
screening statutes or regulations allow exemptions from screening for
religious reasons, and several states allow exemptions for any reason.
Provisions regarding the confidentiality of screening results are included
in state newborn screening statutes and regulations and state genetic
privacy laws, but are often subject to exceptions, which vary across
states. The most common exceptions allow disclosure of information for
research purposes, for use in law enforcement, and for establishing
paternity. While few newborn screening statutes provide penalties for
violation of confidentiality provisions, many states* genetic privacy
statutes provide criminal sanctions and penalties for violating their

provisions, including those related to confidentiality. States Generally
Do

Not Require Consent for Newborn Screening and Most Limit Disclosure of
Screening Information

Page 22 GAO- 03- 449 State Newborn Screening Programs

All states require newborn screening, and state newborn screening statutes
usually do not require consent for screening. Only Wyoming*s newborn
screening statute expressly requires that persons responsible for
collecting the blood specimen obtain consent prior to screening. In
addition, of the three states with only regulations requiring newborn
screening, 38 Maryland*s regulations on newborn screening require consent
for screening. 39 While all states require newborn screening, most newborn
screening

statutes or regulations provide exemptions in certain situations. In 33
states, newborn screening statutes or regulations provide an exemption
from screening if it is contrary to parents* religious beliefs or
practices. Thirteen additional states provide an exemption for any reason.
(See table 5.)

Table 5: Basis on Which Newborn Screening Exemption Is Granted, by State
Basis for exemption Religious objection Any objection No exemption

Alabama X Alaska X Arizona X Arkansas X California X Colorado X
Connecticut X Delaware X District of Columbia X Florida X Georgia X Hawaii
X Idaho X Illinois X Indiana X Iowa X Kansas X Kentucky X 38 These states
do not have newborn screening statutes.

39 Both Wyoming*s newborn screening statute and Maryland*s newborn
screening regulation expressly require informed consent; however, neither
state*s newborn screening statute or regulation defines this term. Consent
Is Generally Not

Required for Newborn Screening, but Many States Allow Religious Exemptions

Page 23 GAO- 03- 449 State Newborn Screening Programs

Basis for exemption Religious objection Any objection No exemption

Louisiana X Maine X Maryland X Massachusetts X Michigan X Minnesota X
Mississippi X Missouri X Montana X Nebraska X Nevada X New Hampshire X New
Jersey X New Mexico X New York X North Carolina X North Dakota X Ohio X
Oklahoma X Oregon X Pennsylvania X Rhode island X South Carolina X South
Dakota X

Tennessee X Texas X Utah X Vermont X Virginia X Washington X West Virginia
X Wisconsin a X Wyoming X Sources: State newborn screening statutes and
newborn screening regulations. Note: GAO analysis of state newborn
screening statutes and newborn screening regulations. a Wisconsin*s
screening statute also authorizes a urine test program to test infants for
causes of

congenital disorders, but provides that no person may be required to
participate in that program.

Page 24 GAO- 03- 449 State Newborn Screening Programs

In over half the states, newborn screening statutes and regulations have
provisions that indicate that information collected from newborn screening
is confidential. 40 , 41 However, they permit information to be released
without authorization from the child*s legal representative in some
circumstances. The most common provision for release of screening
information is for use in statistical analysis or research, generally with
a requirement that the identity of the subject is not revealed and/ or
that the researchers comply with applicable state and federal laws for the

protection of humans in research activities. Some state screening statutes
have additional provisions that allow screening information to be
released. Wisconsin*s screening statute, for example, allows the
information to be released for use by health care facilities staff and
accreditation organizations for audit, evaluation, and accreditation
activities; and for billing, collection, or payment of claims. A few
states have more restrictive provisions. South Carolina*s screening
statute, for example, limits disclosure of the information obtained from
screening to the physician, the parents of the child, and the child when
he or she reaches age 18.

State statutes that govern the collection, use, or disclosure of genetic
information may also apply to genetic information obtained from newborn
screening. Twenty- five states have laws that prohibit disclosure of
genetic information without the consent of the individual; in 23 of these
states, the statutes have exceptions that permit disclosure without
consent. 42 (See table 6.) For example, 14 states* genetic privacy laws
permit disclosure of genetic information without consent for the purpose
of research, provided that individuals* identities are not revealed and/
or the research complies with applicable state and federal laws for the
protection of humans in research activities.

40 We found no limitation on the ability of laboratories or state agencies
to inform health care providers attending newborns with abnormal screening
results. On the contrary, many statutes and regulations require
laboratories and state agencies to inform providers of abnormal screening
results.

41 As defined in federal regulations implementing the Health Insurance
Portability and Accountability Act of 1996, the term health information
would also include newborn screening information.

42 This analysis is based on National Conference of State Legislatures*
information indicating that 29 states have laws that govern the privacy of
genetic information. In 4 of these states, the statutes relate only to
collection and/ or use of genetic information. Most States Have Privacy

Laws or Regulations That Protect Newborn Screening Information to Some
Extent

Page 25 GAO- 03- 449 State Newborn Screening Programs

Table 6: Exceptions to Confidentiality Requirements in States* Genetic
Privacy Laws Exception

State with genetic privacy law Research a Disclosure to health

care provider Peer review or

quality assurance activity Establishing

paternity In connection with

law enforcement or legal proceedings

Arizona X X X Arkansas X Colorado X X Delaware X X Florida X X Georgia X X
Illinois X X X X Louisiana X X X Maryland X X Massachusetts X X

Missouri X X Nevada X X X New Hampshire X X X New Jersey X X New Mexico X
X X X New York X Oregon X X X Rhode Island X South Carolina X X

Texas X X X Utah X Vermont X X X Washington X X X Sources: State statutes.

Notes: GAO analysis of state statutes. States* genetic privacy laws may
also apply to genetic information obtained from newborn screening. a
Information may be disclosed for research, subject to conditions
concerning the release of

individuals* identities and/ or compliance with state and federal laws for
the protection of humans in research activities.

Most state newborn screening statutes and genetic privacy laws do not
include penalties for lack of compliance. According to the National
Conference of State Legislatures, 17 states have laws that provide
specific penalties for violating genetic privacy laws. In 6 of these
states, violations of genetic privacy statutes are punishable by fine and/
or imprisonment. In

addition, the statutes authorize civil lawsuits to obtain damages and, in
most instances, court costs and attorneys* fees. In 10 of these states,
the

Page 26 GAO- 03- 449 State Newborn Screening Programs

statutes provide for civil liability only. In 1 state, violation is
punishable only as a crime.

We provided a draft of this report to HHS for comment. Overall, HHS said
that the report presents a thorough summary of state newborn screening
programs* current practices. (HHS*s comments are reprinted in app. VI.)
HHS said that the report needed to reflect that newborn screening is a
system that, in addition to testing, includes follow- up, diagnosis,
disease management and treatment, evaluation, and education. However, the
draft report did identify the various components of the newborn screening
system. HHS said that there is a need to more comprehensively address
components of the system beyond testing. For example, HHS commented that
there is a need for a coordinated effort in states to train and educate
health professionals and state newborn screening program directors in the
use of newer technologies. In addition, it stated that there is a need to
provide information to families and parents about the screening their
state

provides and the screening options available to them outside of their
state*s program. HHS said that it anticipated that the report would, among
other things, include recommendations to improve state newborn screening
programs. As we noted in the draft report, HRSA has initiated a process to
develop recommendations for state newborn screening programs. The scope of
our review focused on providing the Congress with descriptive information
about state programs.

HHS supported the development of benchmarks to help states evaluate the
quality of the various components of the newborn screening system. It
added that one of the most effective ways the federal government can
support state newborn screening programs is by strengthening the
scientific basis for newborn screening through funding of systematic
evaluation of outcomes and the quality of all components of the newborn
screening system.

In its comments, HHS provided information on its efforts related to
newborn screening. For example, HHS described demonstration projects it
funded to examine the use of new technology and initiatives to improve
family and provider education. In addition, HHS indicated that all of its
programs address the recommendations of the AAP newborn screening task
force and encourage the integration of various newborn screening and
genetics services into systems of care. HHS provided technical comments.
We incorporated the technical comments and other information HHS provided
on its programs where appropriate. Agency Comments

Page 27 GAO- 03- 449 State Newborn Screening Programs

As arranged with your offices, unless you publicly announce its contents
earlier, we will not distribute this report until 30 days after its issue
date. We will then send copies of this report to the Secretary of Health
and Human Services, the Administrators of the Health Resources and
Services Administration and the Centers for Medicare & Medicaid Services,
the Directors of the Centers for Disease Control and Prevention and the
National Institutes of Health, appropriate congressional committees, and
others who are interested. We will also make copies available to others
upon request. In addition, the report will be available at no charge on
the GAO Web site at http:// www. gao. gov.

If you or your staff have any questions, please contact me at (202) 512-
7119. An additional contact and the names of other staff members who made
contributions to this report are listed in appendix VII.

Marjorie Kanof Director, Health Care* Clinical

and Military Health Care Issues

Appendix I: Scope and Methodology Page 28 GAO- 03- 449 State Newborn
Screening Programs

To do our work, we surveyed the health officers in all the states during
October and November 2002 about their newborn screening programs. 1 We
asked each state health officer to work with laboratory and program
administration/ follow- up staff in responding to the questions. The
survey asked for information on the process for selecting disorders to
include in newborn screening programs; laboratory and follow- up
activities; parent

and provider education efforts; expenditures and funding sources; efforts
to evaluate the quality of laboratory testing and program administration/
follow- up; and states* retention and sharing of screening

results. The survey focused only on screening for metabolic and genetic
disorders. We did not ask for information on disease management and
treatment services provided by state newborn screening programs, and the
survey did not collect information on newborn screening for hearing and
infectious diseases.

We pretested the survey in person with laboratory and program
administration/ follow- up staff from the Virginia and Delaware newborn
screening programs. In addition, the survey instrument was reviewed by
staff at the Department of Health and Human Services* (HHS) Centers for
Disease Control and Prevention (CDC), National Center for Environmental
Health, Newborn Screening Branch, and the National Newborn Screening and
Genetics Resource Center, a project funded by HHS*s Health Resources and
Services Administration (HRSA). We refined the questionnaire in response
to their comments. We received responses from all the states. After
reviewing the completed questionnaires and checking the data for
consistency, we contacted certain states to clarify responses

and edited survey responses as appropriate. In addition, we followed up
with four states to obtain more detailed information on their processes
for selecting disorders, evaluations of parent and provider education,
evaluations of the quality of laboratory testing and program
administration/ follow- up, and mechanisms for identifying abnormal cases

misclassified as normal. To identify which genetic and metabolic disorders
are included in states* newborn screening programs, we reviewed the
Resource Center*s U. S. National Screening Status Reports. These reports
provide information on the disorders for which states require screening
and the disorders for which screening is provided to selected populations,
through pilot programs, or by request. 1 *States* refers to the 50 states
and the District of Columbia. Appendix I: Scope and Methodology

Appendix I: Scope and Methodology Page 29 GAO- 03- 449 State Newborn
Screening Programs

To report on efforts by HHS and states to monitor and evaluate the quality
of state newborn screening programs, we reviewed annual summary reports,
proficiency testing results, and other documents from the Newborn
Screening Quality Assurance Program (NSQAP), which CDC operates with the
Association of Public Health Laboratories, and interviewed CDC staff on
states* participation. We also reviewed report findings from the seven
technical reviews of state newborn screening programs that HRSA, CDC, and
the Resource Center conducted from 1999 to 2001. We interviewed Resource
Center staff about the content and findings of these reviews and
interviewed officials in five states about actions taken in response to
the review staff*s findings and recommendations.

To determine how state laws address consent and privacy issues related to
newborn screening, we analyzed state statutes that provide for newborn
screening for genetic and metabolic disorders and state statutes that
relate to privacy of genetic information generally. We also reviewed state
newborn screening regulations as appropriate. The information on states
that require consent for newborn screening is based on our analysis of
state newborn screening and genetic privacy statutes and the newborn
screening regulations in states that do not have newborn screening
statutes. The information on exemptions from screening is based on our
review of state newborn screening statutes and newborn screening
regulations. Information on privacy is based on our analysis of
confidentiality provisions in state newborn screening statutes and, for
those states that do not have confidentiality provisions in their newborn
screening statutes, on confidentiality provisions in newborn screening
regulations. We also analyzed confidentiality provisions in state genetic
privacy statutes.

To identify the newborn screening statutes and regulations that were
within the scope of our review, we relied on research provided by the
National Conference of State Legislatures (NCSL) in fall 2002 and analyzed
only those newborn screening statutes and regulations identified through
that research. With regard to genetic privacy statutes, we analyzed only

those statutes identified by NCSL in an April 2002 report identifying
state genetic privacy laws. 2 We contacted state officials as appropriate
to obtain assistance in locating and interpreting statutory authorities.
We also relied

2 National Conference of State Legislatures, Genetics Policy Report,
Privacy (Washington, D. C.: April 2002).

Appendix I: Scope and Methodology Page 30 GAO- 03- 449 State Newborn
Screening Programs

on NCSL*s determination of the number of states that provide penalties for
the violation of those statutes.

Newborn screening programs are governed by a variety of legal authorities.
We did not research or analyze any case law interpreting state newborn
screening statutes and regulations or genetic privacy statutes, and we did
not research or analyze any written interpretive guidance issued by
states.

We also reviewed relevant literature and obtained information from
individual experts, newborn screening laboratory and maternal and child
health staff in several states, and representatives of organizations
interested in newborn screening, including the American Academy of
Pediatrics, American College of Medical Genetics, American College of
Obstetricians and Gynecologists, American Medical Association, Association
of Maternal and Child Health Programs, Association of Public Health
Laboratories, Association of State and Territorial Health Officials, and
the March of Dimes.

We conducted our work from June 2002 through March 2003 in accordance with
generally accepted government auditing standards.

Appendix II: Number of Disorders Included in State Newborn Screening
Programs, December 2002

Page 31 GAO- 03- 449 State Newborn Screening Programs

Number of disorders Number of disorders for which screening is conducted
using tandem mass spectrometry

(MS/ MS) a, b Screening required for all

newborns Screening conducted for

selected populations, as pilot program, or by request

Screening required for all

newborns Screening conducted for

selected populations, as pilot program, or by request

Alabama 5 0 0 0 Alaska 6 1 0 0 Arizona 8 0 0 0 Arkansas 4 0 0 0 California
4 28 0 28 Colorado 7 0 0 0 Connecticut 8 1 0 0 Delaware 5 0 0 0 District
of Columbia 7 0 0 0 Florida 5 0 0 0 Georgia 8 0 0 0 Hawaii 7 28 0 28 Idaho
5 27 0 26 Illinois 27 0 19 0 Indiana 9 0 1 0 Iowa 6 30 1 27 Kansas 4 0 0 0
Kentucky 4 0 0 0 Louisiana 5 0 0 0 Maine 9 18 1 18 Maryland 9 0 0 0
Massachusetts 10 20 1 19 Michigan 7 0 0 0 Minnesota 5 21 0 19 Mississippi
5 0 0 0 Missouri 5 0 0 0 Montana 3 18 0 14 Nebraska 5 28 0 26 Nevada 6 0 0
0 New Hampshire 6 1 0 0 New Jersey 14 0 6 0 New Mexico 6 0 0 0 New York 10
0 1 0 North Carolina 32 0 25 0 North Dakota 4 2 0 1 Ohio 12 15 6 15

Oklahoma 4 0 0 0 Oregon 33 0 26 0

Appendix II: Number of Disorders Included in State Newborn Screening
Programs, December 2002

Appendix II: Number of Disorders Included in State Newborn Screening
Programs, December 2002

Page 32 GAO- 03- 449 State Newborn Screening Programs

Number of disorders Number of disorders for which screening is conducted
using tandem mass spectrometry

(MS/ MS) a, b Screening required for all

newborns Screening conducted for

selected populations, as pilot program, or by request

Screening required for all

newborns Screening conducted for

selected populations, as pilot program, or by request

Pennsylvania 6 0 0 0 Rhode Island 9 0 1 0 South Carolina 6 0 1 0 South
Dakota 3 29 0 26 Tennessee 5 0 0 0 Texas 5 0 0 0 Utah 4 0 0 0 Vermont 7 0
0 0 Virginia 8 0 0 0 Washington 4 0 0 0 West Virginia 3 1 0 0 Wisconsin 21
5 14 3 Wyoming 6 0 0 0

Source: National Newborn Screening and Genetics Resource Center websites:
http:// genes- r- us. uthsca. edu/ resources/ newborn/ screenstatus. htm,
downloaded on January 9, 2003, and http:// genes- r us. uthsca. edu/
resources/ newborn/ msmstests. htm, downloaded on January 8, 2003.

a States may use their own laboratory to conduct MS/ MS screening or
contract with other laboratories. b Numbers exclude MS/ MS screening for
phenylketonuria, maple syrup urine disease, and homocystinuria.

Appendix III: Information on Disorders Most Commonly Included in State
Newborn Screening Programs

Page 33 GAO- 03- 449 State Newborn Screening Programs

Disorder National incidence a Description Potential outcomes Treatment

Phenylketonuria 1 in 13,947 b Deficiency of an enzyme needed to break down
the amino acid phenylalanine

Mental retardation, seizures Low- phenylalanine diet

Congenital hypothyroidism 1 in 3,044 c Inability to produce adequate
amount of thyroid hormone Mental retardation,

stunted growth Thyroid hormone Galactosemia 1 in 53,261 d Deficiency of an
enzyme

needed to break down the milk sugar galactose

Brain damage, liver damage, cataracts, death

Galactose- free diet Sickle cell diseases 1 in 3,721/

1 in 7,386 e Inherited blood disorder causing hemoglobin

abnormalities Organ damage,

delayed growth, stroke Penicillin, vaccinations Congenital adrenal
hyperplasia 1 in 18,987 Deficiency of an adrenal

enzyme needed to produce cortisol and aldosterone Death due to salt loss,

reproductive and growth difficulties

Hormone replacement and salt replacement

Biotinidase deficiency 1 in 61,319 Deficiency of the enzyme biotinidase,
needed to recycle the vitamin biotin

Mental retardation, developmental delay, seizures, hearing loss

Biotin supplements Maple syrup urine disease 1 in 230,028 Deficiency of
the enzyme

needed to metabolize leucine, isoleucine, and valine

Mental retardation, seizures, coma, death Dietary management

and supplements Homocystinuria 1 in 343,650 Deficiency of the enzyme

needed to metabolize the amino acid homocysteine

Mental retardation, eye problems, skeletal abnormalities, stroke

Dietary management and vitamin supplements

Sources: National Newborn Screening and Genetics Resource Center and
newborn screening literature. a Preliminary data on disorder incidence
presented by the National Newborn Screening and Genetics

Resource Center at the 2002 Newborn Screening and Genetic Testing
Symposium. Incidence rates are based on data from 1990 to 1999. b
Incidence rate is for clinically significant hyperphenylalaninemia, which
includes classical

phenylketonuria and clinically significant phenylketonuria variant. c
Incidence rate is for primary congenital hypothyroidism and does not
include other forms of hypothyroidism. d Incidence rate is for classical
galactosemia and does not include other forms of galactosemia.

e Sickle cell anemia has an incidence of 1 in 3,721, while Hemoglobin
sickle C disease has an incidence of 1 in 7,386.

Appendix III: Information on Disorders Most Commonly Included in State
Newborn Screening Programs

Appendix IV: Selected Disorders States Screen for Using MS/ MS and Number
of States That Screen for Each, December 2002

Page 34 GAO- 03- 449 State Newborn Screening Programs

Number of states a Disorder Screening required for all newborns

Screening conducted for selected populations, as pilot

program, or by request

Fatty acid oxidation defects Carnitine palmitoyl transferase deficiency
type I (CPT- 1) 2 4 Carnitine palmitoyl transferase deficiency type II
(CPT- 2) 4 11 Carnitine/ acylcarnitine translocase deficiency (CAT) 3 8
Long- chain hydroxy acyl- CoA dehydrogenase deficiency (LCHAD) 4 11
Multiple acyl- CoA dehydrogenase deficiency (GA- II) 4 11 Short- chain
acyl- CoA dehydrogenase deficiency (SCAD) 5 11 Medium- chain acyl- CoA
dehydrogenase deficiency (MCAD) 13 8 Trifunctional protein deficiency 3 8
Very long- chain acyl- CoA dehydrogenase deficiency (VLCAD) 4 11 Long-
chain acyl- CoA dehydrogenase deficiency (LCAD) 4 6 2,4 dienoyl- CoA
reductase deficiency 2 2 Organic acidemias Glutaric aciduria type I (GA-
1) 4 11

3- hydroxy- 3- methylglutaryl CoA lyase deficiency (HMG) 4 11 Isobutyryl-
CoA dehydrogenase deficiency 1 6 Isovaleric acidemia (IVA) 5 10 Malonic
aciduria 0 5 3- methylcrotonyl- CoA carboxylase deficiency (3- MCC) 4 11
Methylmalonic acidemia (MMA) 5 10 Mitochondrial acetoacetyl- CoA thiolase
deficiency (3- ketothiolase) 3 10 Propionic acidemia (PA) 5 10 2-
methylbutyrl- CoA dehydrogenase deficiency 2 6 Multiple CoA carboxylase
deficiency 1 4 Other amino acidemias Argininemia 2 10

Argininosuccinate lyase deficiency (ASA) 5 10 Citrullinemia 5 10
Hyperammonemia, hyperornithinemia, homocitrullinuria (HHH) 2 8 Nonketotic
hyperglycinemia 1 6 5- oxoprolinuria 1 4 Tyrosinemia type I 3 10
Tyrosinemia type II 2 7

Source: National Newborn Screening and Genetics Resource Center website,
http:// genes- r- us. uthsca. edu/ resources/ newborn/ msmstests. htm,
downloaded January 14, 2003. a *States* refers to the 50 states and the
District of Columbia.

Appendix IV: Selected Disorders States Screen for Using MS/ MS and Number
of States That Screen for Each, December 2002

Appendix V: State Newborn Screening Program Fees and Expenditures Per
Infant Screened

Page 35 GAO- 03- 449 State Newborn Screening Programs

Newborn screening fee a Expenditures per infant screened b

Alabama $34.00 $32.11 c Alaska 24.00 28.78 Arizona 20.00/ 20. 00 d 25.99 e
Arkansas 14.83 17.95 California 60.00 50.85 Colorado 43.47 30.63
Connecticut 28.00 39.20 Delaware 40.69 61.28 District of Columbia No fee
25.96 Florida 20.00 f Georgia No fee f Hawaii 27.00 26.65 Idaho 18.00
16.11 Illinois 32.00 31.00 Indiana 39.50 28.16 c Iowa 46.00 32.73 Kansas
No fee 17.37 Kentucky 14.50 f Louisiana 18.00 25.62 Maine 33.00 34.37
Maryland 30.00 30.90 c Massachusetts 49.55 50.12 Michigan 42.61 25.69 c
Minnesota 21.00 f Mississippi 25.00 25.00 Missouri 25.00 26.02 Montana
36.92 48.35 Nebraska 50.00/ 54. 60 g 44.01 Nevada 30.00 22.96 New
Hampshire 18.00 22.24 New Jersey 34.00 38.27 c New Mexico 32.00 31.59 New
York No fee 39.92 North Carolina 10.00 14.75 North Dakota 18.00 20.81 Ohio
33.75 21.77 c Oklahoma 10.50 23.43 Oregon 27.00 25.05 Pennsylvania No fee
19.91 Rhode Island 59.00 38.52 South Carolina 21.00 38.28

Appendix V: State Newborn Screening Program Fees and Expenditures Per
Infant Screened

Appendix V: State Newborn Screening Program Fees and Expenditures Per
Infant Screened

Page 36 GAO- 03- 449 State Newborn Screening Programs

Newborn screening fee a Expenditures per infant screened b

South Dakota No fee h Tennessee 17.50 19.34 Texas 19.50 19.74 Utah 31.00
19.62 Vermont 27.00 27.60 Virginia 27.00 30.89 Washington 40.40 39.31 West
Virginia No fee 15.98 Wisconsin 59.50 33.35 Wyoming No fee 16.23

Source: GAO Survey of State Newborn Screening Programs for Genetic and
Metabolic Disorders, October 21, 2002. a We asked states to report their
current fee. States responded to the survey in October and November 2002.
b State fiscal year 2001. c State*s expenditures per infant screened may
not reflect a typical year because the state reported that its
expenditures for state fiscal year 2001 included a significant,
nonrecurring expenditure. d State charges two fees, one at initial
screening and another at the second screening.

e Expenditures include disease management and treatment services. f
Expenditure per infant screened not calculated because state did not
report number of infants screened. g Fee varies depending on laboratory
conducting the screening.

h Expenditure information not available for state fiscal year 2001.

Appendix VI: Comments from the Department of Health and Human Services
Page 37 GAO- 03- 449 State Newborn Screening Programs

Appendix VI: Comments from the Department of Health and Human Services

Appendix VI: Comments from the Department of Health and Human Services
Page 38 GAO- 03- 449 State Newborn Screening Programs

Appendix VI: Comments from the Department of Health and Human Services
Page 39 GAO- 03- 449 State Newborn Screening Programs

Appendix VI: Comments from the Department of Health and Human Services
Page 40 GAO- 03- 449 State Newborn Screening Programs

Appendix VI: Comments from the Department of Health and Human Services
Page 41 GAO- 03- 449 State Newborn Screening Programs

Appendix VII: GAO Contact and Staff Acknowledgments

Page 42 GAO- 03- 449 State Newborn Screening Programs

Helene F. Toiv, (202) 512- 7162 In addition to the person named above, key
contributors to this report were Janina Austin, Emily Gamble Gardiner, Ann
Tynan, Ariel Hill, Kevin Milne, Cindy Moon, and Susan Lawes. Appendix VII:
GAO Contact and Staff

Acknowledgments GAO Contact Acknowledgments

(290202)

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