status of newborn screening programs in the united states · newborn screening14 were also reviewed...

SUPPLEMENT ARTICLE

Status of Newborn Screening Programs in the UnitedStatesBradford L. Therrell, PhDa, Alissa Johnson, MAb, Donna Williams, BSa

aNational Newborn Screening and Genetics Resource Center, Austin, Texas; bNational Conference of State Legislatures, Washington, DC

The authors have indicated they have no financial relationships relevant to this article to disclose.

ABSTRACT

BACKGROUND.Newborn screening programs have expanded over the years; currently,many programs screen for dozens of congenital conditions that, if not detected andtreated early, could result in catastrophic health consequences, including death.Some programs, however, still require universal newborn screening for only a fewconditions. Although all 51 US programs (all states and the District of Columbia)have statutory screening requirements and similarities exist in many parts of thedifferent screening systems, the enabling statutes, rules, regulations, protocols, andfinancing strategies vary dramatically. Consequently, there is a significant lack ofequity in newborn screening services across the country.

METHODS.We investigated program variations existing in and around January 2005and provide baseline information with which future program comparisons can bemade. We used program surveys, electronic searches of legislation, and individualinput (validation) from program decision-makers to create a reservoir of programinformation.

RESULTS. Included is a compilation of pertinent newborn screening statutes, infor-mation from genetic privacy statutes that potentially affects newborn screeningprograms, and a review of state laws that affect specimen and information reten-tion. In addition, program policies related to the use of residual newborn screeningblood spots are reviewed, along with the developmental processes affecting pro-gram informational brochures, including the information contained and the strat-egies for brochure dissemination.

CONCLUSIONS.Building on a progressive and successful history, newborn screeningcontinues as an example of an essential population genetic screening program. Asthe intricacies of screening systems have increased in complexity, so have thepolicy issues that shape program successes and failures. The summary informationin this article provides a basis for national and individual program evaluation.Indeed, some of the information reported here has already been useful for pro-gram refinements reported elsewhere in this supplement.

www.pediatrics.org/cgi/doi/10.1542/peds.2005-2633C

doi:10.1542/peds.2005-2633C

KeyWordsnewborn screening, laws, education,public health, public policy

AbbreviationsPKU—phenylketonuriaHIPAA—Health Insurance Portability andAccountability Act of 1996NNSGRC—National Newborn Screeningand Genetics Resource CenterCORN—Council of Regional Networks forGenetic ServicesAPHL—Association of Public HealthLaboratoriesCDC—Centers for Disease Control andPrevention

Accepted for publication Dec 27, 2005

Address correspondence to Bradford L.Therrell, PhD, National Newborn Screeningand Genetics Resource Center, 1912 WAnderson Lane, Suite 210, Austin, TX 78757.E-mail: therrell@uthscsa.edu

PEDIATRICS (ISSN Numbers: Print, 0031-4005;Online, 1098-4275); published in the publicdomain by the American Academy ofPediatrics

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NEWBORN SCREENING BEGAN in the early 1960s,1,2

with the intent to decrease or to eliminate thecatastrophic effects of preventable mental retardation.3

Special-interest advocacy led many states to enact legis-lation that required screening of all newborns for phe-nylketonuria (PKU). Early laws usually included fundingfor laboratory testing and related follow-up services.Government funding was justified on the basis of costsavings through avoidance of long-term institutionaliza-tion of patients with PKU in state-supported mentalhospitals. Since then, all states and most territorial juris-dictions have incorporated mandated newborn screen-ing for PKU into their public health preventive services.

Over the years, increased scientific and medicalknowledge, coupled with technical advancements, hasallowed newborn screening programs to expand inscope. Policy decisions governing US newborn screeningactivities have been reviewed by the National Academyof Sciences,4 the Institute of Medicine,5 the AmericanAcademy of Pediatrics,6 and others.7–9 In some cases, alegislative mandate has defined the degree of programexpansion; in other cases, expansion has occurredthrough changes in regulations or other mechanismspermitted in the enabling statute. Legislative approachesto newborn screening issues, such as consent require-ments for testing, decision-making processes for testingfor additional conditions, and mechanisms and extent ofprogram financing,6,10 also have varied. As newbornscreening evolved into a comprehensive 6-part sys-tem,9,10 policymakers struggled to keep pace with systemcomplexities, and program variations arose.11

As a necessary part of newborn screening, identifiablepatient information is often available at birthing facili-ties, offices of health care providers associated with thepatient, the screening laboratory, the state/territorialhealth department, and possibly confirmatory laborato-ries and subspecialty clinics, among others. Becausenewborn screening is included in the broader definitionof genetic screening, genetics privacy laws may affectnewborn-screening activities directly. In many in-stances, state/territorial governments have enacted leg-islation and established regulations providing for theconfidentiality of individually identifiable genetic infor-mation. Often consent or refusal options have been in-cluded, to give individuals greater control over theirpersonal information or that of their newborns. Depend-ing on the language used in statutes or regulations, theseoptions may apply to personal information or to speci-mens from which personal (genetic) information can beextracted, such as blood specimens. It is now the casethat newborn screening programs must be aware of howthey are affected not only by newborn screening statutesand regulations but also by other genetic privacy restric-tions, including national laws such as the Health Insur-ance Portability and Accountability Act of 1996(HIPAA).12

To ensure that parents and health care providers whoparticipate in newborn screening are knowledgeableabout the screening system and their roles in it, pro-grams devote considerable resources to education. Asthe number of conditions available for inclusion inscreening increases steadily (and sometimes quickly),programs are faced with the need to provide timelyaccurate information to a host of different entities. New-born screening programs have developed basic informa-tion for parents to address some of these educationalissues. Demand for rapid production of new educationalmaterials may not allow for adequate attention to prep-aration of materials (with respect to content, literacy,and cultural sensitivity), thoughtful distribution of ma-terials, and assessment of the effects of materials. As partof this project, limited background information on dis-tribution and content was obtained, to provide a basis onwhich to refine and to improve educational pamphletsfor parents.

Newborn screening programs are also faced with is-sues regarding storage and management of residualspecimens that remain after newborn screening tests arecomplete. Whereas previously these specimens wereviewed as primarily useful for program quality assuranceand perhaps as final testing material that could be rean-alyzed in cases of late or misdiagnosed conditions, theyhave become increasingly important as possible sourcesfor genetic research. This is of particular importancebecause newborn screening specimens represent themost comprehensive population testing program cur-rently in operation, and specimens are obtained fromessentially every newborn.

This article is intended to summarize the current stateof affairs in critical areas in US newborn screening pro-grams. We acknowledge that many activities are ongo-ing in the newborn screening arena, and we sought totake a snapshot of these activities in or around January2005. This baseline information should prove useful aschanges in newborn screening policymaking evolve inresponse to recent federal initiatives regarding selectionof conditions for screening. Included in the article arevarious summation tables that describe the current sta-tus of testing, privacy, and educational activities. Legis-lation pertinent to these issues also is reviewed. Includedare appendices that delineate important program infor-mation extracted from pertinent laws and regulations.To ascertain the extent to which programs have insti-tuted policies for storage and future use of residual bloodspots, this project investigated the simple question ofwhether policies exist currently and the role of privacylaws and regulations, if any, in current storage policiesand practices. Program personnel acknowledged at theend of the report assisted in the validation of the infor-mation presented.

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METHODS

Privacy and ConfidentialityTo identify newborn screening laws and regulations andprivacy laws and regulations pertaining to newbornscreening, a computerized search of the Westlaw data-base was conducted with variations of the followingterms: infant, birth defect, congenital, genetic, heredi-tary, infant, neonate, newborn, phenylketonuria, andscreening. Therefore, this search was limited by the abil-ity of the database to detect information and by thebreadth of the search terms used. Each of the statutesand regulations identified was accessed, read, and eval-uated for relevance to privacy and other policy issues. Inaddition, comparison was made to a summation of new-born screening laws reported previously,13 to ensurecomprehensiveness of the information accessed. The lat-est available published national summation data onnewborn screening14 were also reviewed for pertinentinformation on births, samples received, number ofscreens required or recommended strongly, and numberof conditions mandated. Updated information on disor-ders included in screening programs was obtained fromthe National Newborn Screening and Genetics ResourceCenter (NNSGRC) through its online database.15

Individual newborn screening statutes and regula-tions were examined to identify confidentiality and con-sent requirements, to determine prescribed methods forselecting conditions for inclusion in newborn screeningmandates, and to identify and to analyze provisions con-cerning the use and storage of dried blood spots. New-born screening statutes that either specified confidenti-ality policies or required the health department topromulgate regulations to address confidentiality issueswere noted. Statutes and regulations that required con-sent or written authorization as part of the screeningprocess were also identified. Genetic privacy laws wereanalyzed to determine whether newborn screening orpublic health programs were exempted. Statutes that didnot exempt newborn screening were reviewed to iden-tify confidentiality and consent provisions that mightapply to state public health employees who providenewborn screening services.

To validate and to update the regulatory informationacquired, an e-mail message was sent to the person ineach state identified as being most likely to have knowl-edge of the regulations (for names, see Acknowledg-ments). Responders were requested to validate and toupdate the interpretive data for their program, withspecific emphasis on current statutes, regulations, andrelevant policies. Nonresponding programs were con-tacted by telephone, and information was obtained fromall 51 US newborn screening programs (50 states and theDistrict of Columbia). These validated responses are in-cluded in the various tables and appendices of this re-port.

Educational MaterialsTo develop information about the process used by pro-grams for educating parents and to provide baselineinformation for refining basic educational materials, aquestionnaire was prepared and disseminated (Table 1).Because the most common form of newborn screeningeducational information for parents was thought to bepamphlets distributed prenatally or at birthing facilitiesaround the time of delivery, questions focused on theinformation contained in such pamphlets and the mech-anism for pamphlet dissemination. The questions usedwere suggested by newborn screening personnel aslikely to provide useful information for comparison andimprovement of the varied educational materials. In-deed, as part of the survey, 50 of 51 programs confirmedthat they distributed educational pamphlets for (and, it ishoped, to) parents. The questionnaires were returnedinitially by almost all programs; the remaining programswere contacted by telephone and responses were ob-tained, so that all 51 US public newborn screening pro-grams were represented by the data. Other pamphletsfrom private newborn screening programs were knownto exist but were not included in this project.

Residual Specimen Storage and Usage PoliciesGuidance published previously by the Council of Re-gional Networks for Genetic Services (CORN)16 and sup-ported by the American Academy of Pediatrics NewbornScreening Task Force6 recommended strongly that new-born screening programs develop policies for retention,

TABLE 1 Questions to Programs Regarding Educational Pamphlets

1. Is distribution of a parent brochure mandatory in birthing facilities?2. Is distribution of a parent brochure a usual activity of prenatal classes?3. Is distribution of a parent brochure a usual activity of obstetricians?4. Does the educational material cite legal authority?5. Does the educational material list disorders included in the screening

program?6. Does the educational material at least briefly describe each disorder?7. Does the educational material indicate how the specimen will be collected?8. Does the educational material indicate when the specimen will be taken?9. Does the educational material indicate when results are available?10. Does the educational material indicate how results will be communicated to

the baby’s doctor?11. Does the educational material indicate how to obtain results?12. Does the educational material indicate the detection rate or accuracy of

tests?13. Does the educational material indicate the existence of false positive results?14. Does the educational material indicate the existence of false negative results?15. Does the educational material discuss what will be done with specimens

after testing?16. Does the educational material discuss the need for retesting in some cases

(ie, inadequate or positive results)?17. Does the educational material discuss the limitation of screening (ie, not all

possible disorders are included)?18. Does the educational material discuss payment for testing?19. Does the educational material discuss whether the test can be refused and

under what circumstances?20. Does the educational material contain a confidentiality and privacy

statement?

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storage, and use of residual specimens remaining aftercompletion of initial newborn screening tests. Thesespecimens, although collected initially for immediatepreventive health purposes, have the potential to beuseful in other studies that may have significant healthimpact, because they provide a ready source of biologicalmaterial containing DNA for essentially the entire pop-ulation of newborns. In many newborn screening pro-grams, the use of specimens beyond the newbornscreening analytical process might not have been con-sidered; therefore, other possible uses may not be de-fined clearly in the law or in the rules and regulations.Consequently, programs may not have clearly definedprotocols for specimen storage procedures, which areoften established on the basis of potential specimen uses.

To learn whether screening programs developed pol-icies in response to earlier concerns and recommenda-tions about storage and use of residual specimens, weconducted a survey of related program policies and ac-tivities in early 2003. A brief questionnaire (Table 2) wassent by e-mail to the newborn screening laboratory su-pervisor or another person at the program level identi-fied as being most knowledgeable about specimen poli-cies. Programs were asked to mail or fax copies of anyregulations, policies, or standard operating proceduresrelating to specimen storage and use after initial new-born screening laboratory analysis. Programs that didnot respond by e-mail were contacted by telephone, sothat responses were collected from all 51 US programs.

In addition to the information obtained from the sur-vey, the latest data submitted by the state newbornscreening programs to the National Newborn ScreeningReport14 were reviewed and clarifying program informa-tion was extracted. NNSGRC staff members, in cooper-ation with an independent consultant knowledgeable inthe administrative policies of state public health labora-tories, evaluated and summarized the data. As a qualitycontrol check, these data were compared with a some-what similar 2002 survey of state laboratory directorsconducted by the Association of Public Health Laborato-

ries (APHL), in cooperation with the Centers for DiseaseControl and Prevention (CDC).17 It is common in sur-veys of newborn screening activities and policies foranswers provided by different responders within a publichealth department to differ slightly. When informationdiscrepancies between the CDC survey and ours wereidentified, telephone contact was made with the new-born screening laboratory authority to resolve the dis-crepancy.

RESULTS

Privacy and ConfidentialityBecause there is no federal law regulating newbornscreening, state and territorial statutes and regulationsgovern newborn screening program implementationwithin their respective jurisdictions. Currently laws existthat either mandate or allow for newborn screening inall states and the District of Columbia. Although it isdesirable to confirm that every newborn obtains a new-born screening test, many programs are not yet able toprovide this information because they do not have dataintegration between the newborn screening programand the vital records (birth certificate) program. There-fore, newborn screening data on the number of speci-mens received are used to provide approximations ofprogram coverage. Basic information from the most re-cently published national newborn screening summarydata,14 updated with current information on selecteditems taken from the NNSGRC Web site (http://genes-r-us.uthscsa.edu), are summarized in Appendix 1. Thesedata include the number of births within the jurisdictionand the number of specimens received during 2001.

The current trend is to use more-general language instatutes and regulations that define screening panels. Forexample, it is becoming more common to see languagesuch as “other detectable amino acid conditions” or “alldetectable conditions” as part of the language of statutesand implementation rules. Examination of the statutesgoverning newborn screening showed that most pro-gram-enabling laws (37 of 51 laws) name �1 disorder inthe program-enabling legislation, usually dating to anoriginal law that mandated screening for PKU. Althoughseveral program-enabling laws name �1 disorder thatmust be included in the screening, all programs reportbeing able to enlarge the number of disorders withoutchanging the law, and only 6 programs (Arkansas, Kan-sas, Kentucky, South Dakota, Virginia, and Nebraska)indicate that the number of conditions screened is thesame as the number included in the statute.

More-detailed information regarding testing and pri-vacy statutes is given in Appendix 2, including statutereferences. Additional summary information about thevarious programs is presented in Appendix 3. Althoughnot all states and territories have specific statutes regard-ing newborn screening, all programs cite statutes thateither mandate or allow for newborn screening. As a

TABLE 2 Questions to Programs Regarding Policies for Storing andUsing Residual Specimens

1. Is there a regulation or policy requiring consent for screening?2. Are there written regulations and/or policies on residual specimen storage?3. Are there written regulations and/or policies on use of residual blood spots?4. What tests are officially mandated?5. What is the process to have a test or tests added (ie, board of health, health

commissioner, or advisory committee)?6. Are there written regulations or criteria to follow when adding tests to the

screening panel (ie, American Academy of Pediatrics guidelines or internalguidelines)?

7. How was the parent brochure developed?8. Was input requested from parent groups and consumers?9. How is the brochure distributed and used (birthing hospitals, obstetrician/

gynecologist, prenatal classes)?10. Is distribution of the brochure mandated?

result of these laws, most newborn screening occursroutinely at the birthing facility, with parents allowedonly an opportunity to refuse screening (opt out) if theyobject. Thirty-three programs permit refusal of newbornscreening on religious grounds, and 12 permit it forreligious or other reasons. Five programs do not allowrefusal, and the statute and regulations in New Hamp-shire are silent on the issue.

Newborn screening statutes and regulations includeconsent requirements in 20 programs. Of these, Mary-land, Wyoming, and the District of Columbia requirethat parents be given the option to consent to screening(opt in), and 18 programs require a parent or guardian togive consent to disclose identifiable information (withlimited exceptions, such as for the purpose of servicedelivery). In Kansas and Maryland, families must con-sent to accept follow-up treatment. In Texas, publichealth personnel must obtain consent to deliver servicesto children with special health care needs. Althoughconsent is required specifically for participation in theMaine expanded newborn screening program, other op-tional testing programs (ie, tests offered beyond thescreening mandate) require or offer consent or refusaloptions in a variety of ways. A written statement ofrefusal is usually specified wherever refusal of mandatedtests is allowed; in some states, a generic refusal form isprovided by the newborn screening program, for unifor-mity of documentation.

Typical information recorded on newborn screeningspecimen-collection devices includes the names of thenewborn and the parent or guardian, their address andtelephone number, a physician associated with the new-born, the infant’s birth date, and limited other informa-tion.18 To protect individual privacy, 28 newborn screen-ing statutes include some type of confidentialityprovisions that restrict either the use of personal infor-mation or the access to actual blood spot specimens.Some states have additional measures to protect theprivacy of personal information. For example, Texas lawallows submission of newborn screening information toa national roster of newborn screening cases only if theidentities of individuals in the roster are protected. Min-nesota and Oregon allow a parent or guardian to suggestcorrections after examining a child’s newborn screeningrecord. Only laws in California, Maryland, Minnesota,and Oregon acknowledge specifically the right of indi-viduals to have access to personal information main-tained by the health department and obtained throughnewborn screening.

Nineteen states/territories have statutes and regula-tions that permit researchers to access and to use new-born screening information for scientific studies, and 10of these have laws or regulations that include specificallyaccess to specimens (Appendix 1). In general, researchinvolving specimens or identified patient informationrequires review by an institutional review board, and

restrictions on sharing information, sometimes includingpublication restrictions, may be required. In all programsthat permit research on residual dried blood spots ex-plicitly, researchers are required to protect the confiden-tiality of patient information.

Genetic information was found to be defined explic-itly as personal property in 5 states, ie, Alaska, Colorado,Florida, Georgia, and Louisiana. (Currently Alaska is theonly state extending this property right to DNA.) Gen-erally it is held, however, that parties involved in thenewborn screening process, such as laboratory person-nel, health department personnel, and primary carephysicians, are permitted access to individually identifi-able information for service delivery or for birth defecttracking and monitoring. In these circumstances, indi-viduals or entities acting as part of the newborn screen-ing process may exchange personal information.

Privacy protections for an individual’s genetic infor-mation (so-called genetic privacy laws) may affect new-born screening policies. A Westlaw search showed 30 states/territories with such laws (Appendix 2). Eight of these lawswere found to have possible application to newbornscreening, because public health activities such as newbornscreening were not exempted specifically from the statute.However, depending on the definition of genetic informa-tion or genetic testing given in a particular statute, currenttechnologies used in newborn screening may not meet thedefinition of genetic testing and may not be included.The remaining 22 privacy laws either exempt publichealth agencies that conduct newborn screening or do notname them in the list of affected entities.

Thirteen states (California, Delaware, Florida, Geor-gia, Idaho, Indiana, Maine, Michigan, Mississippi, Ore-gon, South Carolina, Tennessee, and Utah) have specificpenalties for the violation of state newborn screeninglaws or regulations. Punishments for violating the pri-vacy of newborns screened or failure to maintain theconfidentiality of newborn screening specimens and re-sults range from establishment of grounds for filing acomplaint against the relevant state licensing board (inIndiana) to up to $250 000 in damages and reasonableattorney fees (in Oregon). A violation of newbornscreening laws or regulations in states with criminalpenalties is a misdemeanor, with the exception of Utah,where the hospital or practitioner must report medicalneglect to the state if a parent fails to comply with statelaws or regulations. In Nebraska, the attorney general orthe county attorney may enforce the law through a civilproceeding if a parent fails to respond to a report of apresumptive positive screening test.

Educational MaterialsA review of statutes and regulations that affect educationshowed 20 programs (Appendix 2) with requirementsfor health department personnel or other individualsinvolved in newborn screening to provide specific infor-

mation to a parent or guardian before screening takesplace. Requirements included the provision of oral orwritten information, or both. Educational items identi-fied varied but included information on the right torefuse screening, the panel of newborn screening disor-ders, the consequences of treatment or nontreatment,the need for follow-up testing, retention and storage ofsamples, and confidentiality and privacy issues. Interest-ing issues were sometimes raised by the use or omissionof wording in the statute. In Arkansas, for example, thehealth department must “disseminate information andadvice to the public concerning the dangers and effectsof phenylketonuria, hypothyroidism, and sickle-cellanemia,” but the education is not required specificallybefore newborn screening. In Nebraska, the health de-partment is required to develop an educational bro-chure, but how or when it should be distributed is notincluded. Kansas regulations require prenatal care pro-viders to “discuss and distribute written material describ-ing the newborn screening program.”

Follow-up coordinators from all 51 US newbornscreening programs responded to our questionnaire re-garding preparation and dissemination of educationalpamphlets for parents (Table 3). One program respondedthat it lacked such a pamphlet and was working on itsdevelopment. Of the 50 programs with a newbornscreening pamphlet, 10 programs (20%) reported thatdistribution was a usual activity of obstetricians; 14 pro-grams (27%) reported that pamphlet distribution was ausual activity of prenatal classes. Although it is thoughtthat most birthing facilities distribute program informa-tion pamphlets as part of their information packets fornew mothers, only 19 programs (�40%) reported hav-ing a mandate for such distribution.

The content of program pamphlets was assessedthrough answers to the remaining 17 survey questions.All programs reported including information listing theconditions included in the program and describing whenthe specimen would be collected, and most reportedincluding a brief description of each condition (94%),reference to the collection procedure (98%), and discus-sion of the need for retesting in some situations (94%).More than one half of the programs reported includinginformation that described how results could be ob-tained by the parents (72%), how results would bereported to the primary care physician (62%), and legalauthority for the program (58%). Less than one half ofthe programs reported including information that de-scribed the possibility of false-positive results (48%),when results would be available (40%), and the condi-tions for refusal (38%). Information that described theaccuracy of testing (24%), the limitations of testing(24%), false-negative results (22%), cost/payment fortesting (22%), retention of specimens (14%), and pri-vacy/confidentiality (8%) was included rarely. All pro-grams graciously submitted copies of their pamphlets for

additional evaluation of literacy and cultural sensitivity,the results of which are reported elsewhere in this sup-plement.19

Residual Specimen Storage and UsageDuring 2001, US screening programs reported receivingalmost 5.3 million specimens for analysis.14 The num-ber of specimens received was 33% higher than the re-ported number of births, in part because 8 programs re-quired 2 specimens for every newborn (1 obtained beforehospital discharge and 1 obtained �2 weeks later), andeach reported �90% compliance. Several other statesstrongly recommended a second specimen, to the extentthat compliance exceeded 80%; essentially all remainingprograms required a second sample when the first wasobtained too early (defined as before 24 or 48 hours of age,depending on the program), and all reported receivingsome repeat specimens.

Because laboratory protocols, as well as specimenstorage and later use, can affect whether a second spec-imen is obtained, it is useful to review the various lab-oratory service models operating currently within thecountry (Fig 1). In situations where 1 laboratory servesmultiple states, it is not necessarily the case that all statesserved screen for the same conditions. For most jurisdic-tions, newborn screening is performed as part of theservices of the jurisdiction’s public health laboratory; fora few, screening is contracted to other laboratories (pub-lic or private), usually through competitive bidding. Sev-eral of the northwestern states, Hawaii, and Alaska usethe services of the Oregon State Public Health Labora-tory, Wyoming contracts with the Colorado Departmentof Public Health and Environment, North Dakota con-tracts with the Iowa University Hygienic Laboratory (theIowa public health laboratory), and most of the NewEngland states use the laboratory at the University ofMassachusetts Medical School (affiliated with the Mas-sachusetts Department of Public Health). The Indianaprogram contracts with the Indiana University MedicalSchool, and the Arizona program contracts with theArizona Department of Public Health Services laboratory(through competitive bidding).

Public/private partnerships exist in several programs.The Minnesota Department of Health Laboratory con-tracts with the Mayo Clinic to perform part of the testingpanel, which requires sharing portions of each bloodspecimen submitted. In California, there are 8 privatecontract laboratories under the supervision of the statepublic health laboratory in Berkeley. The South DakotaDepartment of Health contracts with a private in-statepathology laboratory (which subcontracts with anotherlaboratory to offer additional metabolic testing), and thehealth departments in Mississippi, Nebraska, and theDistrict of Columbia contract with a private screeninglaboratory in Pennsylvania (Pediatrix Screening). ThePennsylvania Department of Health has contracts with

TABLE3

Respon

Survey

ofProcessesRe

latedto

State/TerritorialN

rnScreen

ingInform

ationBrochu

Jurisdiction

Distribution

Inform

ationCo

ntainedinNew

ScreeningBrochu

1.Distribution

ofBrochu

reMandatory

inBirthing

Facility

2.Distribution

ofBrochu

reUsualin

Prenatal

Classes

3.Distribution

ofBrochu

reUsualin

Obstetrician/

Gynecologist

Office

4.Cites

Authority

5.ListsA

ndition

sInclud

edinthe

Screening

6.Briefly

Describes

7.Indicates

Specimen

Collection

8.Indicates

Specimen

WillBe

9.Indicates

Testing

Results

WillBe

Available

10.Ind

icates

Results

WillBe

Doctor

11.Ind

icates

toObtain

Results

12.Ind

icates

Detectio

nRateor

Accuracy

13.Ind

icates

Existenceof

False-Positive

Results

14.Ind

icates

Existenceof

False-

Negative

Results

15.Discusses

Happens

toSpecimens

AfterTestin

16.Discusses

theNeedfor

Retestingin

SomeCases

17.Discusses

Limitatio

nsofScreening

18.Discusses

entfor

Testing

19.Discusses

Option(s)for

RefusalIf

Applicable

20.Con

dentiality

orPrivacy

Inform

Alabam

Alaska

Arizona

Arkansas

California

Colorado

Connecticut

Districtof

Columbia

Delaware

Florida

Georgia

Hawaii

Illinois

Indiana

Kansas

Kentucky

Louisiana

Maryland

Massachusetts

Minnesota

Mississippi

Missouri

Montana

Nebraska

Nevada

New Ha

mpshire

NewJersey

NewMexico

NewYork

Carolina

Dakota

Oklahoma

Oragon

Pennsylvania

the New England Regional Newborn Screening Labora-tory and Pediatrix Screening, with hospitals being al-lowed to submit specimens to the contracted laboratoryof their choosing. In Louisiana and Maryland, hospitalsmay send their specimens to other laboratories, althougha central public health laboratory provides most of thescreening. As a result, some hospitals in both states usePediatrix Screening, and one large hospital in Louisianaprovides testing for its own patients.

Results indicate that 9 states (Appendix 1) have spe-cific statutory or regulatory requirements for the reten-tion of newborn screening information and specimens.The prescribed retention periods vary from 1 month toindefinitely. In some state/territorial jurisdictions, par-ents can choose whether to request the return or de-struction of a sample or to continue its storage for re-search purposes after a specified time interval (eg, 2years in South Carolina and Minnesota). Florida, Idaho,and Ohio have requirements relating to retention ofnewborn screening records that do not specify whetherthe specimens themselves are included as a record. Lawsand regulations in California, Maine, and Washingtondeclare newborn screening samples to be the property ofthe state; however, in Maine a parent is permitted toobject to state ownership in writing. The remaining pro-grams seem to be able to destroy or to retain newbornscreening samples and information as long as they arecompliant with general record-retention and sample-storage laws or regulations and internal departmentalpolicies.

Our survey of newborn screening laboratory practices(Appendix 1) found that 37 programs have written pol-icies regarding the storage of newborn screening driedblood spots after completion of the newborn’s screeningtests, leaving 14 programs with no policy. Storage prac-tices were variable, with 24 programs reporting storagetimes of �6 months, in contrast to 8 programs thatreported indefinite storage. Of the remaining 19 pro-grams, 6 stored specimens for 1 year, 7 stored specimensfor 2 to 7 years, and 6 stored specimens for 21 to 23years. Although it was not requested specifically, 2 statesreported saving specimens from diagnosed patients forlonger periods, compared with their routine specimens.Twenty-three programs reported having policies govern-ing the use of residual newborn screening specimens,leaving 28 programs with no written usage policy.

DISCUSSION

Laws and RegulationsAll 51 US newborn screening programs identified legalmandates that either provide specifically for the estab-lishment of a newborn screening program or allow anewborn screening program to be created under abroader health mandate. The newborn screening stat-utes and related policies seek to balance the rights ofRh

odeIsland

SouthCarolina

SouthDakota

Tennessee

Virginia

Washington

WestVirginia

Wisconsin

Wyoming

TotalYes

Yindicatesyes;blank,no;NA,no

brochure.

individual autonomy with the overall public good indetermining whether screening should be voluntary ormandatory. Confounding the issue are considerationsabout the well-being of the child versus the family’sdecision-making rights and the fact that many newbornscreening conditions have rapid severe consequences ifleft undetected and untreated. The result is considerablevariation in opinions about the need for consent for amandated screening program and the decision in 2 statesand the District of Columbia to allow parents the oppor-tunity to consent to newborn screening. Although mostof the other states allow parents an opportunity to optout of newborn screening, primarily for religious rea-sons, it is interesting that 5 programs do not allow forrefusal. In Nebraska, the state’s right not to allow refusalof required testing was upheld recently by the NebraskaSupreme Court. In programs where additional newbornscreening tests are available but not mandated, there isusually a consent or refusal option. An option to partic-ipate is also the usual case when new screening tests areoffered as part of a research protocol or in a pilot studyto determine testing feasibility.

Related to the issues surrounding consent and refusalare the issues of genetic privacy and adequate and ap-propriate parental education in the decision-makingprocesses. In addition to statutes and regulations thataddress newborn screening privacy specifically, broaderhealth laws, regulations, or policies may affect newbornscreening programs. In particular, general public healthand genetic privacy measures may establish consent,confidentiality, or other privacy protections that apply topublic health programs generally or to anyone whomight use the genetic information identified by the pro-

gram. Whether privacy restrictions apply depends on thetype of information and the specific features of the sit-uation in question. Privacy and confidentiality protec-tions typically are strongest in cases where personalidentity is readily available. Laws or regulations mayhave fewer safeguards for unlinked or encrypted infor-mation, because a layer of protection exists between theidentity of the patient and the personal information orthe newborn’s specimen.

The sharing of patient information for public healthprogram purposes, including newborn screening, is of-ten exempted from general health privacy laws and reg-ulations. For example, the Department of Health andHuman Services Standards for Privacy of IndividuallyIdentifiable Health Information require health plans,health care providers, and other entities covered byHIPAA to provide patients with greater control overtheir personal health information. HIPAA rules12 allowspecific exceptions for public health agencies and permitdisclosure of individually identifiable health informationto authorized public health agencies without consent“for the purpose of preventing or controlling disease,injury, or disability, including but not limited to publichealth surveillance, investigation, and intervention.”20

In the case of newborn screening, public health person-nel have access to personal information and are consid-ered HIPAA exempt when delivering newborn screeningservices, including follow-up testing and related medicaland public health assistance. In cases where researchinvolves the use of newborn screening information orspecimens, generally institutional review boards governthe degree of informational privacy. Federally fundedanonymous or unlinked research is exempt from HIPAA

FIGURE 1Different models for newborn screening laboratoryservices within the United States. Hospitals in Penn-sylvania may choose either the University of Massa-chusetts Medical School Laboratory or PediatrixScreening, Inc, also used by Nebraska, Mississippi, andthe District of Columbia. Hospitals in Louisiana andMaryland also may choose to use the state publichealth laboratory or to contract with other screeninglaboratories. Subcontracts also exist in South Dakotasuch that tandemmass spectometry screening is pro-vided by the Institute for Metabolic Disease in Dallasand cystic fibrosis testing is provided by theUniversityof Massachusetts Medical School laboratory.

rules and other federal regulation under the CommonRule, which establishes pertinent human subject protec-tions.21,22

Nearly all states have laws or regulations that protectthe privacy and confidentiality of personal informationcollected and stored by state public health depart-ments.23 Typical methods of securing such informationinclude access restrictions and specific limitations oninformation disclosure and use. Public health privacylaws and regulations may also stipulate different privacyrequirements for different types of information. Becauseanonymous or unlinked statistical information is usuallyconsidered to be public record, a health department maybe required to deidentify or unlink information sharedin this way. Although it increases personal informationprotection, unlinking data for such purposes usually in-creases program costs, because of the time and effortrequired to meet these privacy requirements.

Although statutes and regulations pertaining to birthdefects registries were not specifically researched for thisreport, newborn screening programs might be affectedby such statutes and regulations when there are linkagesbetween the 2. General public health privacy laws andregulations usually safeguard the information accumu-lated in birth defects registries, which often is used forresearch into the prevalence and causes of birth defects.Of the 45 states with an operational or developing birthdefects registry,24 most have laws that provide specialprivacy and confidentiality protections for case-specificdemographic information. Generally these laws restrictaccess, limit disclosure, and specify the purposes forwhich researchers may use registry information. Gener-ally exceptions, when they exist, allow public healthpersonnel to access identifiable information to offer fol-low-up services or to request an affected child’s partici-pation in a research study.

EducationThe need for sound education for parents and healthprofessionals is well understood by newborn screeningprograms, and most report having some components ofan education program in place. The most basic parentinformation is contained in program brochures intendedto provide easy access to fundamental program infor-mation for parents. Basic information for health profes-sionals is contained in a widely disseminated specimen-collection videotape.18

Our study of current program practices showed thatparent education materials may be shared at a nonopti-mal time for education (eg, after delivery).25 It is agreedgenerally that prenatal newborn screening education is amore opportune way to provide the needed informationabout the screening experience. The need for prenataleducation is acknowledged specifically in the Kansasregulations, which require prenatal providers to providenewborn screening education. Surprisingly few pro-

grams (�20%) reported that distribution of educationalpamphlets about newborn screening was a usual activityof obstetricians, and only slightly more (�30%) reportedthat it was a usual activity of prenatal classes. These lowrates illustrate the lack of involvement in newbornscreening programs that obstetricians have had tradi-tionally, although in some programs the law may assignthe responsibility to ensure newborn screening to the“person attending the birth of the newborn.” Similarly,although newborn screening advisory committees ofteninclude pediatricians and family practice physicians,they often overlook the benefits that could be obtainedby including an obstetrician on the committee. As deter-mined from information obtained from newborn screen-ing program reviews, the most common method forproviding educational information about newbornscreening is through information packets provided aspart of the overall information/education process fornew parents. Obstetricians represent a potentially moreeffective and efficient means of transmitting informationto large numbers of women, who could benefit fromhaving the information before they arrive at the hospitalfor the birth and subsequent screening of their new-borns.26 Efforts to include the obstetrics community innewborn screening activities, particularly education,seem to be a pressing need for most newborn screeningprograms.

Retention and StorageProcedures and policies for the management of the re-sidual dried blood spots that remain after newbornscreening continue to vary widely. Despite extensivediscussions over time, the issues surrounding long-termspecimen management have not resulted in consensussolutions. Even the seemingly simple question of howlong to store the residual specimens is not resolved. Oursurvey indicated that, at the time, almost one half of theprograms (23 of 51 programs) stored residual specimensfor �6 months, whereas slightly more than 25% (14 of51 programs) stored them for �21 years. These resultscompare favorably with a similar study of APHL mem-bers (all state and territorial health department labora-tory directors) in 2002.17

The complexity of the storage issue revolves aroundthe fact that, although the residual specimens remainingafter newborn screening may provide usable specimensfor some analyte tests when stored for long periods, thevalidity of the specimens for some tests is questionable ornot satisfactory. However, the DNA contained in thespecimen seems to be stable indefinitely. DNA analysiscannot be relied on to provide confirmation of initialnewborn screening results, for various reasons (eg, mul-tiple mutations associated with the condition or poorgenotype/phenotype correlation), and generally thespecimens that are stored for long periods (beyond a fewmonths) are not considered useful for quality assurance

regarding the original screening tests (with limited ex-ceptions). Therefore, it is agreed generally that speci-mens stored for long periods are of interest primarily fortheir potential research use. This use is made more com-plex by the fact that most newborn screening programsdo not need to obtain consent for testing; therefore, theuse of specimens beyond the newborn screening proce-dure itself raises various legal and ethical questions.

The storage and usage issues related to residual bloodspots after newborn screening were discussed at somelength in a report from CORN.16 The CORN report alsorecommended that screening laboratories should de-velop policies for storage and use of the residual spots.Our survey indicated that �25% of screening laborato-ries (14 of 51 laboratories) still do not have writtenpolicies regarding storage, and more than one half (28 of51 laboratories) reported having no written policy re-garding usage. When these data were pursued, in manycases program personnel reported handling requests foraccess to residual specimens on a case-by-case basis andnoted that requests for residual specimens had beenminimal or had not been encountered. However, manyprograms reported several requests annually, primarilyrelated to additional analyses to determine the cause ofdeath in cases of sudden infant death syndrome or inother unusual circumstances in which a cause was notreadily apparent. Occasional anecdotal requests for useof specimens for forensic purposes were also reported(eg, positive identification of infants when no othermeans of identification were available).

Despite the variations in program policies, regula-tions, and laws that might affect the storage and use ofspecimens, the potential for research use of populationscreening specimens is extensive. The CDC, in coopera-tion with APHL, convened a small working conferencein September 2002 to discuss the possibilities for re-search use of these specimens, including the possibilitiesfor consolidating specimens from programs to providelarger collections of available specimens for possible re-search. As might be expected, the tremendous variationsin program approaches to the issues surrounding the useof residual specimens seemed to present a significantbarrier to specimen consolidation. Nonetheless, confer-ence participants seemed to embrace the possibilities of avirtual bank of specimens in which a data managerwould maintain information regarding specimen avail-ability for research, storage conditions, and limited otherspecimen information, such that an inquiring researcher

might be directed to appropriate specimens for antici-pated projects. However, before such a system is put inplace, it will be necessary to address the considerableconcerns related to privacy and consent. If these barrierscan be overcome, then it may be possible to create avirtual national centralized specimen management sys-tem that would be useful for various types of research.Other ethical, legal, and social issues related to the ques-tion of using residual newborn screening specimens re-main, and it seems that extensive use of newbornscreening specimens accumulated nationally for re-search purposes outside the newborn screening processitself is not likely in the near future.

CONCLUSIONSNewborn screening represents a successful populationgenetic screening program. The fact that a national new-born screening law or financing scheme does not exist inthe United States leads, at least in part, to the currentstate of variation from program to program. Differentlegislative and regulatory approaches, coupled with arange of policies and practices, create a complex diversityof available services, consumer and professional involve-ment, and quality of components of the individual new-born screening systems.

Policymakers in states or territories that have yet toaddress definitively the issues discussed in this articlemay want to consider whether these issues might best bedeveloped statutorily, through rule-making adjunctiveto statutes already in place, through program policychanges, or through some combination of these ap-proaches. Statutes or rules may provide a stricter meansof enforcement and a more visible assurance to thepublic that government has taken action to alleviateconcerns about privacy, confidentiality, and services.However, allowing program personnel the flexibility tocreate and to implement policies may provide a mecha-nism for faster reactions to change as technology andmedical knowledge advance. Increased input fromhealth care professionals involved closely and regularlywith the newborn screening system can provide an in-creased sense of community ownership and involve-ment, with better responses to local needs and concerns.The information synthesized in this article should finduse in comparative analyses between programs andacross time as programs continue to be refined on thebasis of new science and new national recommenda-tions.

APPENDIX1

Screen

ingProg

enOverviewInform

Births

Occurrence

(2001)

National

Centerfor

Health

Statistics)

Screens

Specimens

Received

(2001)

Statute

Changed

Statute

Change?

ScreeningAd

visory

Committee

Rs—Legally

N—Not

butExists.X—

Established

(January

Optional/P

(January2005)

ScreeningFee

(January2005)

Structure

Varies)

Statuteor

nsSpecify

Specimen

Inform

RetentionTime

Written

Specimen

Storage

Policy

Exists

Written

Specimen

Policy

Exists

Statuteor

Specifically

Specimen

Statuteor

Specifically

Inform

Residu

Specimens

AreRetained

Additio

Comments

Alabam

1181488

0$139.33

Stored

at4°C

Alaska

R�30

0$55.00

Arizona

2147028

0$20.00

Policyinlaboratory

manual

Arkansas

0$14.83

California

528539

1531148

X�30

0$78.00

Indefinitely

Stored

at�20°C

Colorado

2123749

0$53.25

Connecticut

N�30

1$28.00

Delaware

0$64.00

Stored

at4°C

Districtof

Columbia

NoIndefinitely

DeferstoPediatrix

Screening;2-y

minimum

Floridac

205991

1295407

27$15.00

Records:3yin

accordancewith

departm

procedures.

Unwritteninternal

understandingon

useofspecimens

Georgiad

134402

1202561

Hawaii

N�30

0$47.00

Specimens:atleast1

Oregonlaboratory

contract

X�30

0$23.00

Recordsm

retained

Oregonlaboratory

contract

Illinois

181086

1187696

R�30

0$47.00

No2mo,4mo,

indefinitely

Routinespecimens;

atriskspecim

diagnosedcases

Indiana

1113980

R�30

0$62.50

R�30

0$56.00

Specimensand

records

mo,then

erated

unless

keptforprogram

evaluationor

released

forresearch

purposes

Kansas

Stored

at�20°C

Kentucky

0$14.50

Stored

at4°C

Louisiana

5$18.00

First2

wkat4°C

18$44.00

Specimensand

records:

Massachusetts

laboratory

APPENDIX1

Continue

Births

Occurrence

(2001)

National

Centerfor

Health

Statistics)

Screens

Specimens

Received

(2001)

Statute

Changed

Statute

Change?

ScreeningAd

visory

Committee

Rs—Legally

N—Not

butExists,X—

Established

(January

Optional/P

(January2005)

ScreeningFee

(January2005)

Structure

Varies)

Statuteor

nsSpecify

Specimen

Inform

RetentionTime

Written

Specimen

Storage

Policy

Exists

Written

Specimen

Policy

Exists

Statuteor

Specifically

Specimen

Statuteor

Specifically

Inform

Residu

Specimens

AreRetained

Additio

Comments

Maryland

1151345

R�30

0$42.50

Stored

at�20°C;

somespecimensat

PediatrixScreening;

2-yminimum

Massachusetts

20$54.75

Indefinitely

Policy:minimum

132159

1141694

0$55.72

Specimensstoredfor

unspecified

period

Minnesota

R�30

0$61.00

Parentsm

ayrequest

sampledestruction

after2

Indefinitely

Mississippi

0$70.00

PediatrixScreening

Missouri

0$25.00

�20°C

Montana

22$39.34

No6–8wkat

Nebraska

27$30.75

Recordsfor25

specimen

disposal

within30

daysafter

90-dretention

period

PediatrixScreeningat

4°Cwith

desiccant

Nevada

R�30

0$60.00

Oregonlaboratory

NewHampshire

1$18.00

Massachusetts

laboratory;advisory

committee

agenda

NewJersey

112639

1124115

6$71.00

NewMexico

0$32.00

Specimen

andrecords

until1ypastageof

majority;printouts

fromscreening

databaseretained

NewYork

255029

1290887

N�30

Specimensand

records:

noperiodoftim

specified

Indefinitely

at4°C

Carolina

119132

1133635

0$10.00

Dakota

0$36.00

Specimensandrecords;

indefinitely

Indefinitely.

Laboratorypolicy:

minimum

152033

1160994

0$33.75

Records:21

Oklahoma

0$75.59

Records:21

Oregon

8$54.00

Specimens

informationup

Pennsylvania

143957

1145904

2contracting

laboratories;

specimensstored

moat4°Cwith

desiccant

RhodeIsland

0$59.00

Massachusetts

laboratory

SouthCarolina

0$42.00

Returnordestructionat

2yorongoing

storageforresearch

Indefinitely

SouthDakota

30$18.53

2moat4°C

Stored

insealed

Tennessee

R�30

0$47.50

3moat4°C

Abnormalspecimens:

indefinitely

370482

2662978

0$19.50

25$31.00

3moat4°C

Vermont

0$33.30

NoIndefinitely

Massachusetts

laboratory

Virginia

1114216

0$32.00

Abnormalspecimens:

Washington

1145814

0$60.90

Specimensand

records;

WestVirginia

Wisconsin

0$65.50

1yat4°C

Wyoming

0$45.00

4031531

5342276

Rindicateslegallyrequired;N,notrequiredbutexists;X,hasn

otbeen

establish

aResearch

tomeetcertaincriteria.See

thestatesummariesinAp

pendix3fordetails.

bIndividualsinColorado

apersonalpropertyrighttotheirgeneticinform

ationunderthe

state’sgeneticdiscrim

inationinhealthinsurancelaw.Geneticinform

ationisnotdefinedinthestatelaw,butgenetic

testingisdefined

as“any

laboratorytestofhuman

RNA,orchromosom

esthatisused

toidentifythe

presenceorabsenceofalterationsingenetic

materialthatareassociated

diseaseorillness.”Genetic

testingislim

itedto“suchtestsasaredirectmeasuresofsuchalterationsratherthan

indirectmanifestationsthereof”

(ColoradoRevisedStatute§10-3-1104.7).

cIndividualsinFloridahave

apersonalpropertyrighttotheresultsofDNAanalysisunderthe

stategenetic

privacylaw.The

lawdoesnotexclude

newbornscreeningactivities.DNAanalysisisdefined

as“the

medicalandbiologicalexam

inationandanalysisofaperson

toidentifythepresence

andcompositionofgenesinthatperson’sbody.The

includesDNAtyping

andgenetic

testing”(FloridaStatuteAn

nals§760.40).

dIndividualsinGeorgiah

ersonalproperty

righttogenetic

inform

ation.Genetic

inform

ationisnotdefinedinthestategenetic

privacylaw

,butgenetic

testingisdefined

as“laboratorytestsofhum

anDNAorchromosom

esforthe

purposeofidentifying

thepresence

orabsenceofinherited

alterations

ingenetic

materialorgeneswhich

areassociated

adiseaseorillnessthatisasym

aticatthetim

eoftestingandthatarisessolelyasaresultofsuch

abnorm

ingenesorgeneticmaterial.”Genetic

testingdoesnotinclude

routinephysicalmeasurements;chemical,blood,and

urineanalyses;testsforabuseofdrugs;andtestsforthepresence

oftheHIV(GeorgiaCode

§33-54-1–8).

eUnderLouisiana’sagenetic

discrim

inationinHealth

InsuranceLaw,geneticinform

ationisthepropertyoftheinsuredorenrollee.Genetic

inform

ationisdefined

as“allinform

ationaboutgenes,geneproducts,in

herited

characteristics,orfamilyhistory/pedigree

isexpressedincommon

language”(Louisiana

RevisedStatuteAn

nals§22:213.7).

fThenewbornscreeningstatutesandregulations

donotstateforhow

thestatemustretainrecords.

APPENDIX2

Inform

ationFrom

Statutes

gulation

StateGen

eticPrivacyan

Screen

Authority

rnScreeningorNew

ScreeningRegu

Screening

nCitatio

nbGenetic

PrivacyStatute

Citatio

Consento

nfidentiality

Wording

inGenetic

PrivacyStatuteMay

Applyto

(Genetic)

Screening

dsforRefusal

toParticipatein

Screening

Parental

Education

Before

Screening

ConsentR

equirements

Screening

Statutes

dentiality

Provision(s)in

Relevant

ScreeningStatutes

andRegu

Alabam

aAlabam

§22-20-3

Alabam

min.Code

§420-10-1

Religious

Alaska

Stat.§18-15-200,

07Alaska

Admin.Code

27.510–590

Alaska

Stat.§18-13-010–100

Arizona

ArizonaRev.Stat.§36-694

ArizonaAd

min.Code

R9-14-501–505

ArizonaRev.Stat.§12-2801–4;

§20-448.02

Todiscloseinform

Arkansas

ArkansasCode

Ann.§20-

15-301–304

ofArkansasR007-

13-004

ArkansasCode

Ann.§16-43-

1101;§20-35-101–3

Yes;consentfor

research

Religious

California

CaliforniaHealth

SafetyCode

§124975–

125001

17Colorado

ofRegs.6500–6510

CaliforniaInsuranceCode

§10149.1

Religious

Todiscloseinform

Colorado

Rev.Stat.§25-4-

1001–1006

ofColorado

1005-4

Colorado

Rev.Stat.Ann.§10-

3-1104.7

Religious

orpersonal

Todiscloseinform

Connecticut

ConnecticutGen.Stat.

Ann.§19a-55

Regs.ofConnecticutState

Agencies§19-13-D41

Religious

areCode

§16.2.201–206

areRegs.

40-700-012

areCode

§16.2.1220–

Religious

Todiscloseinform

Districtof

Columbia

DistrictofColum

biaCode

Ann.§7-831–840

DistrictofColum

Departm

entofH

“NoticeofFinal

Rulemaking”

Inform

edconsentfor

newbornscreening;

consenttodisclose

inform

Florida

FloridaStat.Ann.29

§383.14

FloridaAd

min.CodeAn

n.Rule64C-7.001–7.012

FloridaStat.Ann.§760.40

Yes;consenttoperform

DNAanalysisor

discloseresults

Todiscloseinform

Georgia

GeorgiaCode

§31-12-5–7

GeorgiaComp.Rulesand

Regs.290-5-24-.01–.04

GeorgiaCode

§33-54-1–8

Yes;consenttoperform

genetic

testing;

authorizationto

discloseinform

derived

fromgenetic

testing

Religious

aiiRev.Stat.§321-291

aiiAdm

in.Rules

11-143-1–100

aiiRev.Stat.§431:10A-

Religious

IdahoCode

§39-909–912

IdahoAd

min.Procedure

Act16.02.12

Religious

Todiscloseinform

Illinois

410ILCS

240/.01–.03

IllinoisA

dmin.Code

77-661.10–.70

410IllinoisC

ompiledStat.513

Religious

Indiana

IndianaCode

§16-41-17

410IAC3-3-1–7

Religious

IowaCode

§136A.1–7

IowaAdmin.Code

§641-4.1–4.3(136A)

Todiscloseinform

Kansas

KansasStat.Ann.§65-

180–183

KansasAd

min.Regs.

28-4-501–513

Religious

Forfollow-uptreatment;

todiscloseinform

Kentucky

KentuckyRev.Stat.

§214.155

KentuckyAd

min.Regs.

902§4:030

Religious

Louisiana

Rev.Stat.Ann.

40§1299

Louisiana

Admin.Code48

§6303

Louisiana

Rev.Stat.Ann.§22:

213.7;§40:1299.6

fMaine

Rev.Stat.Ann.Title

22§1531–1533

10-144

CMR283

Religious

Toparticipateinoptional

expanded

screening;

todiscloseinform

Maryland

MarylandHealth

Ann.§13-101–110

ofMarylandRegs.

10.52.12.01–.012

Ann.Code

ofMaryland

Insurance§27-909,Labor

ployment§49B-15,

Consentforscreening,

follow-upand

treatment;todisclose

inform

Massachusetts

MassachusettsGen.Laws

111§3.4E,5,6,24A,

105Code

ofMassachusetts

Regs.270.000

MassachusettsGen.LawsA

§111.70G

Religious

Michigan

MichiganComp.Laws

333.5431

Rescinded

MichiganComp.Laws

§333.17020

§333.17520

Yes;consentfor

predictiveor

presym

genetic

testing

Minnesota

MinnesotaStat.§144.125–

MinnesotaRules

§4615.0300–.0760

Mississippi

MississippiCode

§41-21-201–205;§41-

24-1–5

MississippiR.12-

000-031

Religious

Missouri

MissouriRev.Stat.

§191.331,332

19MissouriCode

ofState

Regs.25-36.010

Vernon’sAn

n.MissouriStat.

§375.1309

Yes;consenttodisclose

Religious

Todiscloseinform

Montana

Ann.§50-

19-201–211

Montana

Admin.Rules

37.57.301–321

Nebraska

NebraskaRev.Stat.§71-

519–24

NebraskaAdmin.Rulesand

Regs.181-2§001–010

NebraskaRev.Stat.§71-1,

Yes;consentfor

predictiveor

presym

genetic

testing

Nevada

NevadaRev.Stat.442.008

NevadaAd

min.Code

442.020–442.050

NevadaRev.Stat.§629.101–

§629.201

Todiscloseinform

pshire

NewHampshireRev.Stat.

Ann.§132:10-a–d

Rulesarecurrentlyunder

revisio

pshireRev.Stat.

§141-H:2

Silent

Jersey

Stat.Ann.

§26:2-510and511

Jersey

Admin.Code

§8:19-1.1–2.13

Jersey

Stat.Ann.§10:5-

43–§10:5-49

Religious

Mexico

MexicoStat.Ann.

§24-1-6

7NewMexico

Admin.

30.6.1–.9;1New

Mexico

Admin.Code

18.665.2090–.2096

MexicoStat.Ann.§24-

21-1–§24-21-7

YorkPublicHealth

Law§2500-a

10NewYorkCode

ofRules

andRegs.69-1.1–1.9

YorkCivilRightsLaw

§79-L

Religious

NorthCarolina

NorthCarolinaGen.Stat.

§130A-125

10ANorthCarolina

Admin.Code

43F.1201–.1204

NorthDakota

NorthDakotaCent.Code

§23-01-03.1;25-17-

00.1–.5

NorthDakotaAd

33-06-16-01–05

Religious

OhioRev.Code

§3701.50.1–.9

OhioAd

min.Code§3701-

55-01–10

Religious

Oklahom

aOklahom

aStat.§63-1-533,

Oklahom

min.Code

310:550

Religious

APPENDIX2

Continue

Authority

rnScreeningorNew

ScreeningRegu

Screening

nCitatio

nbGenetic

PrivacyStatute

Citatio

Consento

nfidentiality

Wording

inGenetic

PrivacyStatuteMay

Applyto

(Genetic)

Screening

dsforRefusal

toParticipatein

Screening

Parental

Education

Before

Screening

ConsentR

equirements

Screening

Statutes

dentiality

Provision(s)in

Relevant

ScreeningStatutes

andRegu

Oregon

OregonRev.Stat.

§433.285–.295,

§192.531–192.549

OregonAd

min.Rules333-

024-0210–0240;Oregon

Admin.Rules333-025-

OregonRev.Stat.§192.531–

Yes;andconsentto

disclosewith

exceptions

Religious

Todiscloseinform

Pennsylvania

PennsylvaniaStatutes35

§621-625

28PennsylvaniaCode

28.1–.41;501.3;501.49

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RhodeIsland

RhodeIslandGen.Laws

§23-13-14

RhodeIslandCode

ofRules

R.23-13MET/HRG

RhodeIslandGen.Laws§

18-52,52.3,§27-19-44,

44.1,§27-20-39,39.1,§27-

41-53,53.1

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SouthCarolina

SouthCarolinaCode

§44-37-30

SouthCarolinaCode

ofRegs.R.61-80

SouthCarolinaCode

§38-93-10–§38-93-60

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SouthDakota

SouthDakotaCodified

nn.§34-24-17–25

Admin.RulesofSouth

Dakota44:19:01:01–03:02

SouthDakotaCodifiedLaws

Ann.§34-14-21–25

Tennessee

TennesseeCode

§68-5-401–506

TennesseeComp.Rules&

Regs.§1200-15-1-.01–.05

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TexasC

n.Health

&Safety§33.001–.038

25TexasA

dmin.Code

37.51–.67

Vernon’sTexasC

ivilCode

§9031

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TodeliverCSHCN

services

UtahCode

Ann.§26-10-6

UtahAd

min.CodeR398-1

§26-45-101–106;§31A-22-

1601,2;§34A-11-101,2

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18Verm

ontStat.An

n.§115

ontCodeRulesR

140-057

ontStat.An

n.§18:9331–

§18:9335

Virginia

VirginiaCode

§32.1-65–69

12VirginiaAd

min.Code

5-70-10–50

VirginiaCode

Ann.§38.2-

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Washington

WashingtonRev.Code

§70.83.020–.050

Chapter246-650

WashingtonAdmin.Code

Rev.Code

ofWashington

§70.02.010

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WestVirginia

WestVirginiaCode

22-1–6

Expired

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Wisconsin

Stat.Ann.

§253.13

Wisconsin

Admin.Code

§115.01–.06

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Wyoming

WyomingStat.§35-4-

801–802

WYRulesand

Regs.HLTH

3880-1

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edconsentfor

newbornscreening

Stat.indicatesStatute;Rev.,Revised;An

nals;Ad

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dministrative;Gen.,General;Regs.,Regulations;Com

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rinsurance

coverage

ofservices.

bThistabledoesnotinclude

newbornscreeningregulations

thatreferonlytofeesforservices,newbornscreeningfunds,orinsurancecoverage

ofservices.

cConsentrequirementsmay

exceptions

asforservice

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inateinform

ationandadvice

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whenthedepartm

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practice.

APPENDIX 3. SELECTED NEWBORN SCREENING PROGRAMSUMMARY INFORMATION

Alabama

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health can adjust the disorder panel.There is no mention of an advisory committee; however,a multidisciplinary nonstatutory committee chaired by ageneticist advises the department.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “It shall be the duty of the adminis-trative officer . . . of the institution . . . or physician,. . . or person attending the newborn. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “Initial mass screening tests . . . shallbe performed by the Public Health Laboratory.”

What Additional System Components Does the Fee Cover?The fee covers only the laboratory testing.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless the parents object on religious grounds. Newbornscreening statutes or regulations do not require the hos-pital or birthing center to provide a parent or guardianwith educational materials before the refusal of screen-ing, and parents are not obligated to provide a writtenstatement of refusal. If a newborn testing positive for anewborn screening disorder is not receiving care, thenthe department is permitted to contact the child’s parentor guardian directly. There is no specific consent orconfidentiality requirement for newborn screening orthe use of residual dried blood spots, although generalpublic health statutes and regulations may apply.

Alaska

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The statute gives authority to the Department of Healthand Social Services. Regulations state, “The departmentwill appoint a committee . . . to consider addition anddeletion of tests. . . .” A multidisciplinary advisory com-mittee has been established and is active.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “A physician who attends a newbornchild. . . . In the absence of a physician the nurse whofirst visits the child shall cause the test to be performed.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “The screening . . . must be performedin a single laboratory designated by the department.”Currently screening is contracted to the Oregon Depart-ment of Health Laboratory.

What Additional System Components Does the Fee Cover?In addition to laboratory testing, the fee covers admin-istration, follow-up services, and consultation.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?The parent or guardian of a newborn may decline toparticipate in the program. Grounds for refusal are notspecified; however, the attending physician or nursemust inform the Department of Health and Human Ser-vices of the decision, and a signed statement of refusal isrequired. Alaska regulations specify that information ob-tained through newborn screening is a “confidentialmedical public health record” and is exempt from thepublic records statute. Individuals and facilities that gen-erate the information must protect it from loss, tamper-ing, and unauthorized access.

Arizona

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The statute states, “Tests shall be specified by rules of theDepartment of Health Services . . . consistent with therecommendation of a newborn screening program com-mittee. . . .” The committee is chaired by the director ofthe department and includes 5 physicians from medicalspecialties in endocrinology, pediatrics, family practice,and obstetrics.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “The attending physician or otherperson required to make a report on the birth shallorder . . . tests for metabolic disorders.”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The newborn screening programcommittee shall prepare and issue a solicitation . . . tocontract for the testing. Proposals may be accepted fromhospitals, clinical laboratories, the state laboratory, andany other qualified public or private persons.” The ad-ministrative code defines the newborn screening labora-tory as “an entity contracted with the department toperform the newborn screening test.” Currently the De-partment of Health Laboratory holds the contract.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, treatment, specialist consultation,the data system, provider/public/parent education, andstaff.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?The parent or guardian of a newborn may decline toparticipate in the program. Grounds for refusal are notspecified. Health care providers must report that the testwas refused on the specimen collection form, submit theform to the Department of Health Services, and docu-ment the refusal in the patient’s medical record. Arizonaregulations do not require a signed statement of refusalfrom a parent or guardian. Before the collection of aspecimen, health care providers must explain the pur-pose of the test, on the basis of the information con-tained in departmental educational materials available toproviders for distribution to parents. The newbornscreening regulation provides for the confidentiality ofnewborn screening results, subject to the general publichealth privacy statutes, which prohibit disclosure of con-fidential information without the written consent of anindividual, a parent or guardian of a minor, or a spouseor legal representative of a deceased individual. Thedepartment may disclose confidential information forscientific research or legal proceedings.

Arkansas

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. There is nomention of an advisory committee; however, a multidis-ciplinary nonstatutory advisory committee is active.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state that, in a birthing medical facility, the“governing body and medical staff [must] adopt andenforce policies” concerning newborn screening.

Are Newborn Screening Laboratory Services Regulated?How?Statute requires the Department of Health to establish acentral laboratory. Regulations specify, “Specimens shallbe submitted to the Division of Public Health Laborato-ries.”

What Additional System Components Does the Fee Cover?The fee covers only laboratory services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless the parents object on religious grounds. The new-

born screening laws and regulations do not require arecord of refusal. The Department of Health must edu-cate the public about “the dangers and effects of phe-nylketonuria, hypothyroidism, and sickle cell anemia.”There are no specific requirements concerning consentor parental education before collection of the blood sam-ple or refusal of screening. The department must trackdiagnosed cases for program evaluation and operationalpurposes and may provide individually identifiable in-formation about diagnosed cases to clinical or researchprograms with the permission of the infant’s parent orguardian.

California

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. There is nomention of an advisory committee, but legislation ispending.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state, “Birth attendants, laboratories, andhospitals shall collect specimens. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The department may provide labo-ratory testing facilities or contract with any laboratory itdeems qualified. . . .” Currently there are 8 contract lab-oratories located regionally, with oversight from the De-partment of Health Laboratory in Berkeley.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, diagnostic testing, quality assurance,and evaluation.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the program unlessthe parent or guardian objects on religious grounds. TheCalifornia Department of Health Services must allow aparent or guardian a reasonable opportunity to objecton religious grounds. State regulations require thatthe physician or birth attendant include a signed writtenrefusal of newborn screening in the infant’s medicalrecord. Birth attendants must provide parents withthe department’s educational brochure, Important Infor-mation for Parents, during prenatal care and in the hos-pital before childbirth or collection of the blood sample.Information obtained from individuals through new-born screening, including test results, is confidential, butall other information pertaining to the program is publicrecord. The statute provides for individual access to

test results and personal information generated throughnewborn screening. Positive test results must be re-ported to the health care provider. With written consentof the parent, guardian, or individual, if older than 18years, the department may release individually identifi-able information. The written consent is compliant withHIPAA and must include the scope of the informationrequested, the parties requesting the information, andthe purposes for the release. An institutional reviewboard approves informed consent for the written disclo-sure of personal information for research purposes.Newborn screening blood spots and related informationare the property of the State of California. The statemay use the specimens and information for programevaluation or research by the department or depart-ment-approved scientific researchers, provided the con-fidentiality requirements described above are met. Thedepartment must translate all forms or brochures refer-enced in state newborn screening regulation to the na-tive language of the parent or guardian if necessary.State statute provides that an individual may receivecompensatory and civil damages not greater than$10 000, in addition to attorney fees and the cost oflitigation, for a breach of confidentiality by the program.

Colorado

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Board of Health has authority. A nonstatutory ad-visory committee makes recommendations.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “The physician, nurse, midwife, orother health professional attending a birth . . . shall beresponsible for the collection. . . .”

Are Newborn Screening Laboratory Services Regulated?How?Appropriate specimens . . . shall be forwarded . . . to thelaboratory operated or designated by the Department ofPublic Health. . . . Currently the Department of PublicHealth Laboratory provides testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration andfollow-up services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the program unless theparents object on religious grounds or have a personalobjection to the administration of tests or treatment. Allinformation other than statistical data is confidential.

Informed consent is required for disclosure of individu-ally identifiable information.

Connecticut

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Commissioner of Health has authority. There is anonstatutory advisory committee.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Responsibility is given to “the administrative of-ficer . . . in charge of each institution caring for newborninfants. . . .”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “Specimens shall be submitted to the. . . State Department of Health, or to a laboratory ap-proved for the purpose. . . .” Currently the Department ofPublic Health Laboratory provides testing.

What Additional System Components Does the Fee Cover?The statute specifies a fee to “cover all expenses. . . including testing, tracking, and treatment.”

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the program unless theparents object on religious grounds. If a parent declinesto participate, then the individual offering screeningmust report the refusal to the Department of PublicHealth and place a signed statement of refusal in theinfant’s medical record. The department must direct di-agnosed newborns to treatment centers in a mannerconsistent with confidentiality requirements. State reg-ulations require that identifying information accompanyeach specimen for future reference, but they do notcomment on specimen storage. The Department of Pub-lic Health must maintain newborn screening records for5 years. These records must include the tests performedand results. The regulations do not mention blood spotstorage. Currently blood spot specimens are discardedafter 6 months.

Delaware

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?Regulations state, “as recommended by the DelawareNewborn Screening Program with the approval of theDirector of the Division of Public Health.” There is anonstatutory multidisciplinary committee that advisesthe program.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The regulations state, “in order of responsibility: thehospital, alternate birth facility, or other licensed healthcare facility, the newborn’s primary care provider, theparent or legal guardian.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “the laboratory designated by the Di-vision of Public Health.” Currently the Division of PublicHealth Laboratory provides the testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, and medical consultation.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?There is not a state statute pertaining to newborn screen-ing per se; however, reporting requirements under thestate’s birth defects surveillance system and registry stat-ute (see citation above) include biochemical abnormal-ities, and the state Board of Health has exerted its au-thority to adopt regulations for newborn screeningunder the state statutes requiring the Department ofHealth and Social Services to protect the well-being ofmothers and children. The state is in the process ofrevising its regulations. Regulations require all newbornsto participate in the state newborn screening programunless a parent or guardian objects on religious grounds.Families who decline testing must file an affidavit swear-ing their religious beliefs. The person who administersscreening must provide an informational pamphlet de-veloped by the department. The department must recorddemographic information on newborns screened, forsurveillance and monitoring. Under state statutes, indi-viduals or institutions who believe in treating illnessthrough prayer are not required to participate in thebirth defects surveillance system, which includes new-born screening information. A parent or guardian alsomay refuse to disclose personal information concerningan infant’s birth defect on religious grounds. In addition,the department may not compel an individual to partic-ipate in “medical or public health examination, treat-ment, or supervision.” The birth defects registry statuteprotects the confidentiality of information related to thediagnosis or treatment of a biochemical disorder re-ported to the department and prohibits the disclosure ofindividually identifiable information. The Department ofHealth Services is permitted to share personal informa-tion in the registry with authorized agencies. Newbornscreening regulations state that all newborn screeningrecords are confidential. Release of summary, statistical,or anonymous information is permitted. The departmentmay release data for approved research projects. The

type of data that may be released is not specified. Aviolation of state newborn screening regulations is pun-ishable by a fine of not less than $100 or more than$1000.

District of Columbia

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The statute allows the mayor to add or to delete dis-orders on the advice of the Committee on MetabolicDisorders. Established by statute, this committee (9 mem-bers appointed by the mayor, ie, 4 consumers, 4 physiciansincluding a geneticist or endocrinologist, and the director ofthe Department of Human Services) must consider, amongother issues, the medical, psychological, ethical, social, andeconomic effects of programs to identify and to treat met-abolic disorders.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “Each hospital and maternity center. . . shall make available [screening] for. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “a laboratory designated by themayor. . . .” Currently Pediatrix Screening (Bridgeville,PA) provides testing services.

What Additional System Components Does the Fee Cover?There is no fee; however, hospitals are billed for tests bythe contracting laboratory.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Participation in the District of Columbia newbornscreening system is voluntary. Hospitals and birthingfacilities must inform parents of the availability and pur-pose of tests. Parental consent for newborn screening isrequired. Parents may decline to participate in the pro-gram. Hospitals and birthing facilities are required todocument consent or nonconsent in the infant’s medicalrecord. The District of Columbia statute prohibits dis-crimination against or stigmatization of carriers of met-abolic disorders. All information gathered through thenewborn screening process is confidential medicalrecord except for deidentified statistical data. The depart-ment may disclose personal information with parentalconsent; however, the department must first explain thescope of the information requested and the purpose ofthe disclosure.

Florida

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority, “after consul-tation with the Genetics and Infant Screening AdvisoryCouncil. . . .” Council members include 2 consumers, 3practicing pediatricians, 1 representative of each of 4medical schools, the Secretary of Health (or a designee),and representatives from 2 department child health pro-grams.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the attending health care provider.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations allow testing in an “approved laboratory”meeting defined criteria. Currently the Florida Depart-ment of Health Laboratory performs testing.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Parents may refuse to participate in newborn screeningfor any reason. The refusing parent must sign a writtenrefusal, to be given to the physician or person adminis-tering screening. The Florida Department of Health mustmaintain a confidential registry of infants testing positivein newborn screening, for delivery of services, adminis-tration of the program, and epidemiologic studies. Thedepartment must safeguard the information sufficientlyto ensure the confidentiality of individuals in the regis-try, which is exempt from the public records statute. Thenewborn screening statute references specifically gen-eral health records statutes, which prohibit the release ofany record by department personnel without consent.The laboratory must maintain records of screening re-sults and follow-up testing for 3 years. Specimen storageis not addressed. A violation is punishable as a misde-meanor, with a penalty of up to 60 days in jail and a$500 fine.

Georgia

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The director of the Division of Public Health must “seekthe advice and guidance of the Newborn Screening Ad-visory Committee.” A multidisciplinary committee ofprofessional and consumer representatives with knowl-edge and expertise in newborn screening programs ismandated by regulation.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations note that the physician attending the new-born must “have a specimen . . . taken before . . . dis-charge.” For nonhospital births, the person in charge ofthe facility must supply written notice to the parents.

Are Newborn Screening Laboratory Services Regulated?How?Regulations state “a laboratory approved by the Depart-ment of Human Resources. . . .” Currently the Divisionof Public Health Laboratory provides all testing.

What Additional System Components Does the Fee Cover?There is no fee, but the statute defines a 5-componentsystem, ie, “screening. . . ; retrieving potentially affect-ed. . . ; diagnosis; . . . therapy; . . . assessing programs.”

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the program unless theparents object on religious grounds. If an infant’s physi-cian is unable to reach the parents regarding test results,then the local health department may contact the familydirectly. Violations of the regulations are punishable asmisdemeanors.

Hawaii

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has the authority. An advi-sory committee is not required; however, there is aNewborn Screening Advisory Committee that meets 1 or2 times each year and more often if needed.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the person in charge of each institu-tion . . . physician attending the birth . . . person assist-ing the birth of a child not attended by a physician. . . .”

Are Newborn Screening Laboratory Services Regulated?How?Regulations require testing at a laboratory designated bythe Department of Health. Currently the Oregon Depart-ment of Health Laboratory performs testing.

What Additional System Components Does the Fee Cover?The statute allows the fee to be used for “the payment ofits lawful expenditures, including but not limited tolaboratory testing, follow-up testing, educational mate-rials, continuing education, quality assurance, equip-ment, and indirect costs.” The fee is used to pay for thesalaries and fringe benefits of the newborn screeningprogram staff members; FedEx overnight courier ser-

vices; specimen collection and handling charges; a con-tracted nutritionist, pediatric endocrinologist, and met-abolic specialist services; and newborn screening servicesfor the indigent.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the program unless theparents, guardians, or other persons having custody orcontrol of the child object on religious grounds. TheHawaii Department of Health must distribute an infor-mational brochure about newborn screening to parentsand all individuals and institutions involved in the pro-cess. If parents, guardians, or other persons having cus-tody or control over the child refuse screening, then theperson overseeing the screening process must explainthe medical implications of refusal to the family, includea written objection in the patient’s medical record, andsend a copy of the written objection to the department.Hawaii statutes require the Department of Health toadopt rules regarding the retention of records and re-lated data, educating parents, and confidentiality. Ac-cordingly, state regulations require that laboratoriesstore specimens so that retesting is possible for �1 yearand that they develop a system to log and to trackspecimens. The department also must make an informa-tional brochure available to parents. The newbornscreening program and physicians consider all informa-tion, including records, correspondence, and individu-ally identifiable information, confidential. The depart-ment may use such information only for the purposes ofmedical intervention, counseling, scientific research, orfulfilling reporting requirements, while keeping thename of the patient confidential at all times. The new-born screening regulations refer to Hawaii’s generalmedical records statute, which requires public agenciesto store records for 7 years after the individual whoreceived services reaches the age of majority; however,public health screening is exempt.

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The director of the Department of Health and Welfarehas authority. There is no mention of an advisory com-mittee, and none currently exists.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “It shall be the duty of the adminis-trative officer . . . or the person responsible for the reg-istration of the birth. . . .

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “The department shall provide accessto newborn screening laboratory services.” It goes on todescribe duties for “all laboratories receiving dried bloodspecimens on infants. . . .” Currently the Oregon Depart-ment of Health Laboratory performs laboratory testing.

What Additional System Components Does the Fee Cover?The fee covers only laboratory costs; however, the pro-gram provides some follow-up services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless the parents object on religious grounds. Statenewborn screening regulations refer to general Depart-ment of Health and Welfare rules concerning medicalrecords, which require written authorization for use anddisclosure of health information outside the department.The form must specify the type of information re-quested, as well as the intended purpose and the user.The administrator of the responsible institution or birthregistrant is required to keep a record of specimens,identifying the patient, attending physician or attendant,date of collection, and person who collected the sample.In addition, the department must maintain records of allinfants with PKU and other preventable diseases andmust oversee the local health department’s treatment ofindividuals with disease. Under state statutes, a violationof newborn screening regulations is punishable as a mis-demeanor.

Illinois

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Public Health has authority. Regula-tions specify an advisory committee to advise on theselection of consultants to work with subprogramswithin the newborn screening program.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states that primary responsibility lies withthe “physician on attendance at or immediately afterbirth of the newborn. . . .” The statute also allows thephysician to delegate this responsibility.

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “All specimens . . . shall be submittedto . . . Illinois Department of Public Health. . . .”

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, and treatment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the program unless theparents object on religious grounds. The parent orguardian must provide a written statement of objectionto the physician or individual who administers the test.The birthing facility or health care provider must keepthe written statement of refusal and notify the Depart-ment of Public Health, in writing, of the refusal. Thedepartment must maintain a registry of cases for thepurpose of diagnosis and treatment of confirmed positivecases. The department must maintain the confidentialityof patient information and may request an annual up-date on the developmental progress of an affected childfrom a consultant or health care provider.

Indiana

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has the authority “after con-sultation with medical authorities. . . .” Indiana’s New-born Screening Task Force makes recommendationsconcerning the addition of screening disorders.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “Each hospital and physician shalltake or cause to be taken a blood sample. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The state [health] department shalldesignate at least one laboratory. . . .” The statute alsostates that this section “does not prevent other facilitiesfrom conducting tests for disorders.” Currently testing isperformed at the Indiana University Medical Center.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, and treatment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate unless the parents objecton religious grounds. The person who administersscreening must inform parents of the implications ofrefusal and place a signed written statement of refusalfor participation in the child’s medical record. The Indi-ana State Department of Health must have a confidentialregistry for tracking and follow-up monitoring of allnewborns and a system for using residual dried blood

spots for epidemiologic research without identifying in-formation. The newborn screening laboratory mustmaintain confidential records, in accordance with re-quirements of the Indiana State Board of Health. Theserecords are open to examination by board personnel ordesignated agents for administrative purposes. The localhealth department may contact families directly for fol-low-up testing if necessary. Failure to comply with statenewborn screening regulations is grounds for filing acomplaint with the appropriate licensing board.

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health has final approval. The BirthDefects Advisory Committee advises the Department ofHealth director regarding program issues. Regulationsspecify committee representation from “professionalgroups, agencies, legislators, consumers, and individualswith an interest.”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The regulations state, “the licensed attending health careprovider. . . .” A health care provider is defined as alicensed physician, physician assistant, nurse, nursepractitioner, or certified nurse midwife.

Are Newborn Screening Laboratory Services Regulated?How?Regulations state the University of Iowa Hygienic Labo-ratory (the state public health laboratory).

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, and a metabolic formula fund.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?A parent or guardian may refuse to participate in new-born screening on any grounds. The attending healthcare provider must inform the parent or guardian of thetype of specimen, the collection method, the nature ofthe disorders screened, and the consequences of treat-ment and nontreatment. If testing is refused, then thehealth care provider must have the parent or guardiansign the official Iowa newborn screening waiver form,must add the form to the child’s medical record, andmust submit a copy to the Birth Defects Institute. TheBirth Defects Institute maintains a central registry thatincludes statistical information on genetic disorders.Identifying information is confidential. The departmentmay release confidential information to a parent orguardian, to a health care provider with consent of theparent or guardian, or for approved research. State reg-

ulations specify that the specimen collection form mustinclude the sample and attached identifying informa-tion. The central newborn screening laboratory mustretain specimen collection forms attached to identifyinginformation for 1 month, in a secure area. Forms maythen be incinerated or retained for program evaluationor research. If specimens are released for research, thenthey must be made anonymous, so that they are unableto be linked back to the patient. The Iowa Birth DefectsCommittee, Iowa Department of Public Health, and Hu-man Subjects Review Committee must approve researchproposals.

Kansas

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Secretary of Health and Environment has authority.There is no mention of an advisory committee; however,a nonstatutory committee of health department staffmembers is active.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the administrative officer . . . or at-tending physician caring for infants. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute designates the Department of Health andEnvironment Laboratory.

What Additional System Components Does the Fee Cover?There is no fee; however, the statute mandates educa-tion, screening, follow-up services, and treatment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the newborn screeningprogram unless a parent or guardian objects on religiousgrounds. Prenatal care providers must inform parentsabout the newborn screening program. The person whoobtains the specimen must provide the same informa-tion, as well as the right to refuse participation. Consentis required to monitor infants who receive follow-uptesting or treatment. The Kansas Department of Healthand Environment must maintain a registry of confirmedcases, including identifying information. The parent orguardian of a diagnosed infant must notify the depart-ment of an address change or a change in health statuswithin 3 months after its occurrence.

Kentucky

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Secretary for Health Services designee “shall applyfor any federal grants . . . to expand or improve pro-

grams to provide screening. . . .” There is no mention ofan advisory committee; however, a multidisciplinarynonstatutory committee, including representatives fromMedicaid, meets regularly.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the administrative officer or otherperson in charge of each institution. . . .”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “Hospitals and institutions may submitblood samples to the Cabinet for Human Resources. . . Division of Laboratory Services. . . .” In addition,“Hospitals and institutions may conduct their own test-ing program within . . . or through a licensed medicallaboratory.” Results of hospital testing must be reportedto the state laboratory. Currently no testing is beingreported by hospitals, and the state laboratory performsall testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers part of the cost forprogram administration, follow-up services, and treat-ment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the newborn screeningprogram unless the parent or guardian objects in writingon religious grounds. Kentucky newborn screening stat-utes or regulations contain no other specific provisionswith respect to confidentiality and privacy regardingnewborn screening information and samples, consent orthe right to refuse screening, or the use of samples.

Louisiana

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health and Hospitals may add to thegenetic conditions tested “after consultation with medi-cal geneticists from each of the state’s medical schools.”There is no requirement for an advisory committee;however, one has been established and meets twiceyearly.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the physician attending a new-born . . . or the person attending a child who was notattended by a physician.” In cases where repeat testing isnecessary, the regulations state, “Repeat screeningshould be arranged by the primary pediatrician; how-ever, it may be done by any primary health care provider

of clinical facility qualified to perform newborn screen-ing specimen collection.”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The Department of Health and Hos-pitals shall establish and maintain a diagnostic labora-tory. . . .” Regulations state, “The Office of Public Healthmaintains a laboratory . . . the newborn screening bat-tery may also be available through other approved lab-oratories.” Currently Pediatrix Screening and Women’sHospital (Baton Rouge, LA) are approved laboratories.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, limited treatment, surveillance, andeducation.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?A newborn whose parent or guardian objects to partic-ipation is exempt from newborn screening. The statepublic health laboratory may conduct experiments,projects, and other undertakings to develop tests fordetection of metabolic and genetic conditions. There isno mention of whether the laboratory may use newbornscreening samples and information for this purpose. Thestatute on genetic conditions and newborns provides forthe confidentiality of prenatal and postnatal genetic testresults, with the exception of those for which reportingis mandated specifically by statute, such as newbornscreening test results. A genetic test, as used in thissection of the statutes, is not defined. If the infant doesnot have a designated health care provider, then thenewborn screening laboratory must contact a parent orguardian directly concerning positive test results. Thenewborn screening laboratory must consider nationalguidelines and recommendations with respect to its op-eration.

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?Regulations state, “The department will consider changesin conditions to be screened as requested by the Bureauof Health, the medical community, or the public.” Also,“The department shall appoint an advisory committee toadvise the program on issues related to the screening ofnewborns.”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state, “the responsible hospital, birthingcenter, physician, principal birthing attendant, or healthcare provider. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute allows the Division of Maternal and ChildHealth to “enter into agreements and contracts for thedelivery of genetic services.” Another section on contracteligibility states that the contracted project or activity “shallinclude some or all of the following services . . . newbornmetabolic testing, laboratory services. . . .” Currently theUniversity of Massachusetts provides testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers program adminis-tration, follow-up services, education, and counseling.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the newborn screeningprogram unless a parent or guardian objects on religiousgrounds. A parent or guardian must provide a writtenobjection, which is then included in the child’s medicalrecord. The hospital or birthing center must inform theBureau of Health in the Department of Human Servicesof the refusal. Counseling and educational services pro-vided to women at risk for maternal PKU, offeredthrough a genetics program, are voluntary. The bureaumay offer additional tests available through the newbornscreening laboratory, on a voluntary basis. The parent orguardian must consent before the laboratory conductsadditional testing. Results of optional tests also are re-ported to the bureau. The department is responsible forthe storage of residual dried blood spots in a secure stablearea for 5 years, in a manner that allows them to beretrieved. After 5 years, the department must destroythe specimens in a way that preserves confidentiality.Unless prohibited in writing by a parent or guardian,dried blood spots and related information are the prop-erty of the state. The department may use specimens forprogram evaluation and research purposes or for depart-ment-approved scientific research, “to improve thehealth of mothers and children,” without consent. Pub-lished studies using newborn screening samples or in-formation must report anonymous information only.The department may release a specimen with identifyinginformation for research and testing, with the specificconsent of a parent or guardian. A violation of statenewborn screening regulations is punishable by up to 6months in county jail.

Maryland

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health and Mental Hygiene can se-lect disorders with the advice of the Advisory Council onHereditary and Congenital Disorders. The statute speci-fies the composition and duties of the advisory council.

There are 11 voting members including 1 member fromthe Senate, 1 member from the House of Delegates, 4professionals from the fields of hereditary or congenitaldisorders appointed by the governor, and 5 consumers.There are 5 nonvoting members.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state, “The individual in charge of an insti-tution or . . . designated representative” and, for birthsoutside an institution, “the person required to prepareand file the certificate of birth” is responsible for offeringtesting.

Are Newborn Screening Laboratory Services Regulated?How?Currently regulations state that the Department ofHealth and Mental Hygiene shall perform all analyses.Revision of this part of the regulations is under consid-eration.

What Additional System Components Does the Fee Cover?The fee covers laboratory costs only. The program alsooffers extensive follow-up and counseling services if re-quested.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Participation in any hereditary and congenital disordersprogram is wholly voluntary. A parent or guardian mayrefuse to participate for any reason. The individual ad-ministering the screening must inform the parents orguardian of the reasons for the test, the risks involved,and the right to refuse; must provide ample time forrefusal; and must record consent or refusal in the child’smedical record. The parent or guardian must sign astatement explaining the tests as part of the informedconsent process. Parental oral or written consent is re-quired for follow-up testing. All information obtainedthrough newborn screening is confidential, includingthe registry of diagnosed cases maintained by the depart-ment. The department must keep newborn screeninginformation coded and must treat it as a confidentialmedical record. The department may disclose informa-tion if the parent or guardian or the individual screened(if �18 years of age) provides informed consent, whichmust include the scope of the information requested forrelease and the purpose. Anonymous information is sub-ject to the public records statute. If the responsible partyis unable to contact a child’s parents regarding test re-sults, then the department may contact them directly.The department must make the infant’s medical record,which includes a record of test results, available to par-ents on request. Maryland statute requires that a carrierof a hereditary disorder not be discriminated against orstigmatized, and it creates a commission to protect the

“freedom, health, and well-being of citizens of this statefrom improper treatment or advice, discrimination, vio-lation of privacy, or undue anxiety that results from anyhereditary and congenital disorders program.” The stat-ute clarifies that any recommendations made with re-gard to discrimination do not deprive an individual ofthe right to redress for discrimination. There is no men-tion of the use of residual specimens in the currentstatute or regulations. The Secretary of the Departmentof Health and Mental Hygiene is required to enforcestate newborn screening regulations, but a particularmethod of enforcement is not specified.

Massachusetts

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Commissioner of Health has authority and “shallestablish a permanent advisory committee to ad-vise . . . on matters pertaining to newborn screen-ing. . . .” A committee exists and is active.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state that the attending physician is respon-sible.

Are Newborn Screening Laboratory Services Regulated?How?Regulations state that specimens should be delivered tothe Department of Public Health. The statute (111§4E)authorizes the department to conduct its program inconjunction with certain other agencies. An agreementbetween the Department of Public Health and the Uni-versity of Massachusetts Medical School designates thattesting and other functions of newborn screening beconducted by the University of Massachusetts MedicalSchool.

What Additional System Components Does the Fee Cover?Regulations allow a fee to cover testing, notification, andfollow-up services to ensure treatment of affected new-borns. By agreement, the University of MassachusettsMedical School provides the Department of PublicHealth with all initial and required repeat laboratorytesting services, collection kits, sample transport to thelaboratory, clinical consultation, administration, datamanagement, research, pilot studies, outreach and edu-cation (including printed and Internet materials in mul-tiple languages), and other items necessary for full-ser-vice integrated newborn screening.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the state newbornscreening program unless a parent or guardian objects

on religious grounds. The attending physician must doc-ument the refusal of screening services by a parent orguardian.

Michigan

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. A nonstatutoryadvisory committee makes recommendations to the de-partment.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “a health care professional in chargeof the care of a newborn . . . or if none, the health pro-fessional in charge at the birth. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The Department of Health may re-quire that the tests be done by the department.” Cur-rently the Department of Health Laboratory providestesting.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, and some treatment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the screening program.Informed consent requirements for genetic testing donot apply to the newborn screening program. The de-partment must have a brochure explaining the natureand purpose of testing, describing retention and disposalpolicies, and indicating that specimens may be used forresearch and additional specimens may be obtained forhome retention. The Michigan Department of Healthmust develop a schedule for retention and disposal ofresidual samples consistent with standards for laboratoryaccreditation and federal statutes. The department mustmake a record of the disposal, signed by a witness. Thedepartment must permit the use of specimens for re-search during the retention period if it is confidentialand adheres to the Common Rule. A violation of thestate newborn screening statute is punishable as a mis-demeanor.

Minnesota

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?By statute, the Commissioner of Health has the author-ity to make changes recommended by the advisory com-mittee. The advisory committee is established by statuteto consider ethical issues surrounding testing, treatment,

and handling of data and specimens generated throughtesting requirements. Committee members must include�1 person representing “parents, primary care provid-ers, clinicians, and researchers specializing in thescreened disorders, genetic counselors, birth hospitalrepresentatives, newborn screening lab professionalsand nutritionists, and other experts as needed. . . .”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute assigns the responsibility for newbornscreening depending on the circumstances of the birth,ie, the facility administrator in an institution caring forinfants �28 days of age or the person required to registerthe birth of the child or the midwife attending the birthif the birth occurred outside such an institution.

Are Newborn Screening Laboratory Services Regulated?How?The rules state that specimens are to be sent to theDepartment of Health Laboratory. Currently specimensare sent to the Department of Health Laboratory with aportion of the specimen removed; that portion is sent tothe Mayo Hospital laboratory for tandem mass spec-trometry testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration andfollow-up activities.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?The individual collecting a blood sample must informparents about the newborn screening program, includ-ing the reasons for screening, the right to refuse onreligious grounds, and the fact that the state may retainsamples. Parents may decline to participate or may havetesting performed but request destruction of the sampleand records within 2 years. If participation is declined,then a signed written statement by the parents must beadded to the child’s medical record. The Minnesota De-partment of Health must maintain a registry of diag-nosed cases with identifying information, for the pur-pose of follow-up monitoring, and all data must betreated as private under the public health records stat-ute, which is referenced specifically in the state newbornscreening statute. The public health records statute per-mits patients to access data and to suggest corrections ifinformation is incorrect. State statute establishes an ad-visory committee, the duties of which include consider-ation of ethical issues surrounding testing, treatmentand handling of data, and specimens generated throughtesting requirements.

Mississippi

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health has authority, on the advice ofthe Genetics Advisory Committee, which includes “atleast 2 pediatricians and 1 consumer . . . from a family. . . with a newborn with an abnormal screening test.”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the physician or other health careprovider attending the infant. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “in laboratories located in the UnitedStates.” Currently Pediatrix Screening provides testing.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the newborn screeningunless a parent or guardian objects on religious grounds.The Board of Health must create a pamphlet to informparents about the newborn screening program, but itsuse is not required. Regulations specifically include di-agnosed cases of newborn screening disorders as part ofthe state birth defects registry. The State Department ofHealth may obtain records or test results for late-diag-nosed cases. The statute provides for security of theregistry, to facilitate research and to protect confidenti-ality. The department may not disclose identifiable in-formation, but statistical data are public record. Thedepartment must maintain records of newborn screen-ing tests for 2 years. The storage of samples is not ad-dressed in state statutes or regulations, but it is includedin the contractual obligations of the laboratory that per-forms the testing. Misuse of newborn screening infor-mation is punishable with a fine of up to $500 for eachoccurrence.

Missouri

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has the authority to changethe disorder list. No advisory committee is mentioned;however, a multidisciplinary Newborn Screening Stand-ing Committee is active.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “The attending physician, certifiednurse midwife, public health facility, ambulatory surgi-

cal center, or hospital shall ensure that appropriate spec-imens are collected and submitted to the Department ofHealth and Senior Services.”

Are Newborn Screening Laboratory Services Regulated?How?The statute specifies the Department of Health and Se-nior Services Laboratories.

What Additional System Components Does the Fee Cover?The fee is for the newborn screening tests only. Theprogram provides a formula for the treatment of inher-ited diseases of amino acids and organic acids based onincome eligibility after all benefits from third-party pay-ers are exhausted.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the state newbornscreening program unless a parent or guardian objectson religious grounds. The person who administersscreening must provide educational materials, includingthe consequences of treatment and nontreatment. Asigned written refusal is required; it must be made partof the infant’s medical record and sent to the Depart-ment of Health and Senior Services.

Montana

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Public Health and Human Serviceshas authority to determine the screening panel and topromulgate regulations. An advisory committee is notrequired; however, an ad hoc committee of the Familyand Community Health Bureau Advisory Council hasbeen convened as needed to provide recommendationsto the department.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “a person in charge of a facility where-in a child is born . . . or cared for or a person responsible forthe registration of the birth. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “an approved laboratory . . . the lab-oratory of the department, or a laboratory approved bythe department.” Currently the department’s laboratoryprovides testing, with optional testing performed by theWisconsin Department of Health Laboratory.

What Additional System Components Does the Fee Cover?The fee covers laboratory testing only.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Montana newborn screening statutes or regulations con-tain no provisions with regard to confidentiality, privacy,consent or the right to refuse screening, or the use ofresidual samples.

Nebraska

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health and Human Services has au-thority. A nonstatutory advisory committee exists.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states the attending physician or person reg-istering the birth.

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “the laboratory designated by thedepartment. . . .” Currently Pediatrix Screening providestesting.

What Additional System Components Does the Fee Cover?The $10 fee is available for administration, follow-upservices, and treatment, but currently it supplementstreatment costs entirely.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?The Department of Health and Human Services mustprovide a pamphlet explaining the nature of tests per-formed as part of newborn screening, the purpose andvalue of retaining a specimen, the procedures for reten-tion and disposal, and the possibility of use for research.Although state statutes or regulations do not specifydetails of pamphlet distribution, distribution as part ofthe newborn screening process is reported to be com-mon practice. Refusal of newborn screening is not al-lowed. A legal challenge is currently in process. Thenewborn screening program must maintain a centraldatabase of reported data, for the purposes of programevaluation and quality assurance. The department maydisclose anonymous or statistical reported data for re-search. The hospital or birthing institution must providethe department with necessary information to track, tomonitor, and to provide for the care and treatment ofnewborns diagnosed with a disorder. State regulationsfor retention and disposal of samples must comply withnationally recognized standards for laboratory accredita-tion and federal statutes, require the destruction of sam-ples in the presence of a witness, and provide for arecord of disposal. The newborn screening laboratorymust maintain for 25 years an index or catalog of spec-

imens processed, including an identifier for each speci-men, test results, a record of disposal or specimen releasefor research, and the signature of the individual whodisposed of or released the specimen. If a specimen is notreleased for research, then the laboratory must disposeof the specimen within 30 days, in a manner that pro-tects the identity of the individual screened. If a parentfails to respond to notification of an infant’s presumptivepositive screening results, then the attorney general orcounty attorney may enforce the statute through a civilproceeding.

Nevada

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health, on recommendation of thestate health officer, has authority to change the testingpanel. Tests are not put into regulation. The Board ofHealth is kept informed of the current test battery andany need for changes. There is input from a statutoryMaternal and Child Health Advisory Committee ap-pointed by the governor.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “any physician, midwife, nurse, ob-stetric center, hospital . . . or mother of any infant. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The Board of Health adopts regulations governing exam-inations and tests to detect preventable inheritable dis-orders. Regulations stipulate that, “The sample must beplaced in a kit supplied by the health division . . . andmailed . . . within 24 hours after the sample is taken.” Acontract is for laboratory services. Currently the OregonDepartment of Health Laboratory provides testing.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Parents may file a written objection to participation innewborn screening. All information obtained by thestate or local health department is confidential. The statehealth officer and the Bureau of Children’s Serviceschief must ensure the confidentiality of information andmust inform individuals involved in newborn screeningof confidentiality policies. Parental consent to discloseinformation is required, with the exception of summary,statistical, or other anonymous information; however,the state health officer or a designee may review iden-tifiable records and contact the family of a newborn to

inform them that the newborn may have a disorder, toconfirm a diagnosis, or to offer services.

New Hampshire

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Commissioner of the Department of Health andHuman Services has rule-making authority, with ap-proval of the legislature. An advisory committee is notrequired but a multidisciplinary committee of individu-als with an interest and/or expertise in newborn screen-ing has been formed to make recommendations regard-ing issues of policy and procedure and to ensure thehighest program standards.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the physician, hospital, nurse mid-wife, midwife, or other health care provider attending anewborn. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The revised rules will designate a screening laboratory.Currently the University of Massachusetts MedicalSchool provides testing by contract.

What Additional System Components Does the Fee Cover?The fee covers the contracted laboratory costs, includingtesting, transport, pamphlets, reporting, and consulta-tion.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?New Hampshire’s newborn screening statute containsno provisions with regard to confidentiality, privacy,consent or the right to refuse screening, or the use ofsamples, but the statute requires the Commissioner ofthe Department of Health and Human Services to adoptrules and regulations to carry out the program. Legisla-tive approval is required. Current regulations have ex-pired, and revision, in conjunction with the advisorycommittee, is underway.

New Jersey

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The statute states, “The Department of Health, in con-sultation with appropriate advisory groups, shall. . . .”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations give responsibility to the birth attendant orresponsible physician.

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify the Department of Public Health andSenior Services Laboratory.

What Additional System Components Does the Fee Cover?The current $34 fee covers only laboratory services. Ifapproved, the new fee would include follow-up servicesand limited treatment services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in the newborn screeningunless parents object on religious grounds. The personadministering screening must inform parents of the pur-pose of the test and the need for screening, provideeducational materials, and document refusal in the in-fant’s medical record. It is the responsibility of the chiefexecutive officer of a hospital or other birthing facility toensure that parents are informed and supplied with ed-ucational materials provided by the state newbornscreening follow-up program. Newborn screening infor-mation is confidential. Only nonidentifiable informationis public record.

NewMexico

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Secretary of Health and Environment has the au-thority to change the panel, with recommendationsfrom the New Mexico Pediatrics Society. There is nomention of an advisory committee; however, the pro-gram has formed an ad hoc advisory committee.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?“Every hospital shall take a first blood sample from eachinfant born. . . .” If the infant is not born in a hospital,“the attending physician, nurse, nurse-midwife, mid-wife, or responsible person shall arrange to have theblood sample taken by a physician, a hospital, or arepresentative of the department’s local health office.”

Are Newborn Screening Laboratory Services Regulated?How?The statute states that the department may provide lab-oratory services or contract with another agency or state.Currently the New Mexico Department of Health Labo-ratory performs testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, confirmatory testing, education/training, and contracts for genetic services (metabolismand dysmorphology clinics).

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Parents may decline participation in the newbornscreening program for any reason. A signed writtenstatement of refusal is required and is entered into thechild’s medical record. Physicians must explain newbornscreening before parents’ refusal of testing, so that par-ents may make an “informed decision.” State statutes orregulations do not specify the extent of information to beprovided. The New Mexico Department of Health main-tains confidential records and a database of diagnosedcases for tracking infants and administering the program.Records and initial and secondary specimen forms arestored until 1 year after the child reaches the age ofmajority. The contents of records and the database andspecimen collection forms are confidential. Printed in-formation from the database is also confidential and isretained for 2 years.

New York

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Commissioner of the Department of Health hasauthority. There is no mention of an advisory commit-tee; however, a multidisciplinary newborn screeningtask force is constituted for advice as needed.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?By statute, the administrative officer or other person incharge of institutions caring for infants or the birth at-tendant (for a nonhospital birth) is responsible.

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify the Wadsworth Center Laboratory ofthe Department of Health.

What Additional System Components Does the Fee Cover?There is no fee. The program provides follow-up trackingand educational services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless parents object on religious grounds. New YorkState Department of Health regulations require that thebirthing facility, physician, or public health officer in-form parents about the purpose and need for screeningand provide them with educational materials. Specimensmust be stored with accompanying identifying informa-tion. According to state regulation, the department alsomust store newborn screening information in electronicformat. The state laboratory must record requested di-

agnoses and case follow-up information and must main-tain tracking records for diagnosed cases.

North Carolina

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Commissioner of the Department of Health hasauthority. The State Board of Health director appointsmembers to a nonstatutory advisory committee.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The regulations state the attending physician is respon-sible.

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify the North Carolina State Health De-partment Laboratory.

What Additional System Components Does the Fee Cover?The fee covers only testing. Follow-up services, educa-tion, and treatment are supported by state funds.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?Physicians must submit a blood sample for newbornscreening unless a parent objects for any reason. TheNorth Carolina Department of Health and Human Ser-vices is required to develop educational materials aboutnewborn screening for parents, although state statutesand regulations do not require the distribution of theinformation at a particular time. Parents who declinescreening must provide written documentation of re-fusal, which must be added to the child’s medical record.

North Dakota

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Health Council has authority. There is nomention of an advisory committee; however, a nonstat-utory advisory committee is active.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the physician attending a newbornchild, or the birth attendant in the case of an out-of-hospital birth.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state that a laboratory will be designated bythe State Department of Health. Currently the IowaDepartment of Health Laboratory provides testing.

What Additional System Components Does the Fee Cover?The fee covers only laboratory costs. The program pro-vides short-term follow-up services and education. Aquarterly metabolism clinic is funded by another stateprogram.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless parents object on religious grounds. The personwho administers the test must obtain a signed statementof refusal to be added to the child’s medical record, anda copy of the statement must be sent to the Departmentof Health. The department must maintain a registry ofdiagnosed cases. Public access is limited to statistical andnonidentifiable information. The physician, dietician,and Children’s Special Health Services Program of theDepartment of Human Services may access identifiableinformation to provide services and service coordina-tion. Researchers with proposals approved by the de-partment, sponsored by an appropriate entity, and sub-ject to an institutional review board may have access toinformation. Studies must protect the confidentiality ofmedical information, and researchers must return alldocuments provided by the department and copies ofdocuments with identifiable information. As part of theapproval process, researchers must explain the intendedpurpose of the study and procedures for maintainingsecurity of confidential information, must consent tosupply copies of written materials before submission to apublisher, must provide written consent for reproduc-tion of documents by the department, and must agree topay all departmental costs incurred as a result of theproject. The department may retain newborn screeninginformation and testing materials, including blood sam-ples, indefinitely or destroy them after 10 years. Thedepartment may destroy �10-year-old information andmaterials with the state health officer’s written approval.The method of destruction must preserve confidential-ity.

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Director of Health has the authority, with the adviceof the Newborn Screening Advisory Council. The 14-member multidisciplinary council is appointed by thedirector and includes representatives with interests andexpertise in newborn screening. Regulations give exam-ples of groups to be included.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Ohio Administrative Code regulations state, “the child’sattending physician, the certified nurse-midwife, the

certified nurse practitioner, or the clinical nurse special-ist. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute allows the Director of Health to designate thelaboratory. Regulations specify the Ohio Bureau of Pub-lic Health Laboratories.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, and treatment (including formula).

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless parents object on religious grounds. Participationin optional testing is voluntary. The hospital or birthingcenter must provide parents with written notice ofscreening, which includes a description of the newbornscreening program and the opportunity to receive addi-tional optional tests. If parents decline screening, thenthe hospital or birthing center must send a written re-fusal of testing to the Ohio Department of Health. Hos-pitals and birthing centers are required to establish writ-ten protocols for tracking newborn screening. Thedepartment may share information within programs orwith others under grant or contract with the departmentfor the purposes of locating a newborn or the newborn’sparent or guardian or performing departmental func-tions and responsibilities. If a physician is unable toreach a parent or guardian regarding a test result, thenthe department may contact them directly. Families un-able to be reached are reported to Ohio regional geneticcenters. The laboratory is required to maintain recordson screened newborns for �21 years. Retention require-ments do not refer directly to specimens.

Oklahoma

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health has authority. Regulationsrequire an advisory committee to be “appointed by theCommissioner of Health to advise the department onnewborn metabolic disorder screening issues.”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state that the physician or licensed or certi-fied birth attendant is responsible. Regulations also de-fine roles for the hospital, providers, and screening pro-gram in ensuring that screening occurs.

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The State Board of Health is autho-rized to set up laboratory facilities and use existing facil-ities. . . .” Regulations state the “Newborn MetabolicDisorder Screening Laboratory means a laboratory oper-ated . . . or certified by the department. . . .”

What Additional System Components Does the Fee Cover?The fee covers laboratory testing only.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless parents object on religious grounds. Hospitals arerequired to distribute educational materials regardingthe newborn screening program. The person who ad-ministers screening must place a written statement ofrefusal in the child’s medical record and send a copy ofthe refusal to the newborn screening program. Newbornscreening information is confidential. Permissible use isrestricted to service delivery, program administrationand evaluation, and data analysis. The laboratory muststore each sample with an identifier and link patientinformation and test results to the identifier. The labo-ratory must maintain information for 21 years.

Oregon

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Human Services has authority. Thereis no mention of an advisory committee.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state, in order of responsibility, “the hospi-tal, alternate birthing facility, or other health care facili-ty . . . the practitioner . . . the parent or legal guardian.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify the State Public Health Laboratory.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, treatment, and education.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless the parents object on religious grounds. The per-son who administers screening must send a written re-fusal to the Department of Human Services. The refusalmust use the wording provided in department regula-tions. The public health laboratory also must maintain

demographic data on newborns for program administra-tion, evaluation, and statistical analysis. Privacy andconfidentiality issues for newborn screening samplesand information are addressed in Oregon’s genetic pri-vacy statute. Newborn screening is excluded from theinformed consent requirement to obtain genetic infor-mation under the state genetic privacy statute, but thestatute requires the department to protect the confiden-tiality of stored samples and newborn screening infor-mation. The genetic privacy statute permits retention ofDNA samples or genetic information, including newbornscreening specimens and information, as set forth bydepartment regulations. Genetic privacy regulationsspecify that the department may store newborn screen-ing samples or information for up to 1 year. Samples orinformation may be used for anonymous research unlessan individual chooses to decline participation after noti-fication regarding the research project. Studies must fol-low department rules for research standards and theCommon Rule. Researchers must encrypt or code sam-ples, which must be destroyed at the conclusion of aproject or when an individual withdraws from a study,unless informed consent to retain the sample for anextended period is obtained.

An individual can access, and if necessary correct,personally identifiable genetic information being storedby the department. Consent to disclose individuallyidentifiable genetic information, including newbornscreening results, is required. A violation of statutespertaining to consent, confidentiality, or the use of sam-ples is punishable by fines ranging from $100 to$250 000, depending on the intent of the defendant, inaddition to attorney fees in some circumstances. Theretention of newborn screening samples or disclosure ofnewborn screening information in violation of statutes ispunishable as a misdemeanor.

Pennsylvania

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority, with the ap-proval of the Board of Health. There is no mention of anadvisory committee; however, an ad hoc multidisci-plinary advisory committee exists.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state that the birth center or hospital, or thehealth care practitioner who delivered the newborn, isresponsible.

Are Newborn Screening Laboratory Services Regulated?How?Regulations state that the testing laboratory is “the li-censed clinical laboratory under contract with the de-

partment to perform testing. . . .” In addition, other leg-islation allows hospitals the option of submittingspecimens to any laboratory contracted by the state.Currently the University of Massachusetts School ofMedicine Laboratory and Pediatrix Screening providetesting.

What Additional System Components Does the Fee Cover?There is no fee. The program provides testing, confirma-tory follow-up testing, assessment, and diagnosis ofnewborns with abnormal screening results. Optionalsupplemental screening is provided at most hospitalsthrough contracted laboratory services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless the parents object on religious grounds. Healthcare providers must place a written statement of refusal,signed by the parent or guardian, in the child’s medicalrecord. Health care providers also must inform the de-partment of the number of patients who were notscreened and must provide an explanation. The new-born screening laboratory, department, or other entitiesinvolved in the newborn screening program may haveaccess to test results during various stages of the new-born screening process and may not disclose any iden-tifying information except to a parent or guardian or thedesignated health care provider. Disclosure by the de-partment is permitted for the purposes of service deliv-ery or with the consent of a parent, guardian, orscreened individual who has reached the age of major-ity, has graduated from high school, is married, or ispregnant. If a health care provider is unable to contact afamily regarding an abnormal or unsatisfactory result,then the department may contact the family directly.

Rhode Island

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. A nonstatutoryadvisory committee makes recommendations to the de-partment.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The regulation states that the “physician and/or midwifeattending a newborn child shall cause said child to besubject to screening tests for. . . .”

Are Newborn Screening Laboratory Services Regulated?How?By regulation, “The Division of Laboratories shall pro-vide specimen collection testing kits. . . .” In addition,“screening tests performed . . . elsewhere than the Divi-

sion of Laboratories must be performed by a laboratoryapproved by the director and include the tests cited. . . .”Currently the University of Massachusetts MedicalSchool provides testing.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,personnel, equipment, and other related costs.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless parents object on religious grounds. Rhode Islandnewborn screening statutes and regulations contain noother specific confidentiality provisions regarding theprivacy of newborn screening information and the use ofsamples or consent and the right to refuse screening.

South Carolina

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Board of the Department of Health and Environ-mental Control has authority. There is a nonstatutoryadvisory committee, which submits recommendations tothe board.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations give responsibility to the “attending physi-cian” or “person in attendance” if no physician ispresent; if the birth is unattended, then “the parents orlegal guardian shall notify the health department. . . within 3 days of delivery so that a specimen may becollected.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state that all screening tests shall be per-formed at the Department of Health and EnvironmentalControl.

What Additional System Components Does the Fee Cover?The fee covers only laboratory testing.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless parents object on religious grounds. The Depart-ment of Health and Environmental Control must de-velop and provide educational materials to inform par-ents about newborn screening, the benefits of bloodstorage, and blood storage options, and hospital staffmembers or others at the place of birth, under the di-rection of the attending physician, must document thatthey provided an informational brochure to parents. If

parents decline to participate, then they must completethe departmental religious objection form. All depart-mental newborn screening forms must include informa-tion on the benefits of newborn screening and bloodsample storage. By regulation, the department is re-quired to store all medical records, specifically includingnewborn screening tests, in an environment that pre-vents unauthorized access and deterioration. Newbornscreening records must be treated as confidential andretained until the screened individual reaches the age of18 years. If a physician is unable to contact the parents orguardian regarding test results, then the departmentmay contact them directly. Information obtainedthrough the newborn screening system is confidential.Disclosure is permitted, after the completion of a depart-mental request form, to parents or guardians, an infant’sphysician, or a screened individual who has reached theage of majority. In addition, the department may releasespecimens that are deidentified but coded for later de-partmental use in anonymous, confidential, scientificstudies approved by a departmental institutional reviewboard, unless prohibited by parents, guardians, or ascreened individual who has reached the age of major-ity. The decision to prohibit participation in researchstudies must be documented on the departmental bloodsample storage options form. A parent or guardian canrequest the return of a blood sample 2 years after testing,destruction of a blood sample 2 years after testing, orstorage for anonymous confidential study. Identifiableinformation may not be released for use in research. Ifresearch reveals information that may be beneficial tothe individual whose specimen was obtained, then thedepartment may contact the parent, guardian, orscreened individual who has reached the age of major-ity. Samples collected before the effect of legislationenacted in 2002 are retained unless the parent or guard-ian of a child whose specimen is stored requests itsdestruction or return. A violation of the state newbornscreening statutes is a misdemeanor punishable by up to$50 000 and 3 years of imprisonment.

South Dakota

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. An advisorycommittee is not required by statute or regulation, butan ad hoc committee exists.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state, “The parents, guardian, or custodianof each infant is responsible . . . the attending physician,other health professional, hospital, or public health fa-cility shall notify parents . . . of the responsibility. . . .”

Are Newborn Screening Laboratory Services Regulated?How?Regulations state, “The department shall designate thelaboratories that are authorized to perform newbornscreening services. . . .” Currently Sioux Valley ClinicalLaboratories (Sioux Falls, SD) provides testing.

What Additional System Components Does the Fee Cover?The fee covers only laboratory costs at the contract lab-oratory.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screening. Aphysician, hospital, or other responsible party must no-tify legal counsel for the department by telephonewithin 24 hours if a parent or guardian refuses to par-ticipate. South Dakota newborn screening statutes andregulations contain no other specific provisions withregard to confidentiality and privacy of newborn screen-ing information and samples or consent or the right torefuse screening or the use of samples.

Tennessee

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. The Commis-sioner of Health “shall appoint a committee to consultwith the department . . . composed of 1 representativefrom each regional genetic and sickle cell center, . . . 2members at large, and the chief medical officer for thestate.”

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations assign responsibility to “every chief admin-istrator officer of a hospital and the attending physician,”to “any health care provider of delivery services” if thebirth occurred in a nonhospital setting, or to “the parentor guardian or custodian” if the birth occurred outside ahealth care facility and without the assistance of a healthcare provider.

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify that specimens “must be submittedto the Division of Laboratories, State Department ofHealth.” Currently the Division of Laboratories providesall testing.

What Additional System Components Does the Fee Cover?The fee covers only testing. Education, follow-up ser-vices, counseling, and treatment are funded by the Di-vision of Maternal and Child Health.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.Parents who decline must sign a written refusal state-ment. By statute, people of the state must be “ex-tensively informed” of the nature and effects of PKU,congenital hypothyroidism, galactosemia, and other ge-netic/metabolic defects. The Department of Health musthave a reporting system for data collection and storageand for compilation of statistical information on thecauses, treatment, and prevention of newborn screeningdisorders. Statutes specifically require inclusion of diag-nosed cases in the confidential state birth defects regis-try. Researchers may conduct studies with newbornscreening information but must identify and code infor-mation and maintain confidentiality. The departmentmust record specific information regarding the informa-tion accessed, including the name of the person associ-ated with the information, the date of access, and thepurpose. Researchers may publish nonidentifiable statis-tical information. The state or local health departmentmay contact a parent or guardian directly about a sus-pected genetic or metabolic disorder. Willful or negligentdisclosure of newborn screening information is a misde-meanor. In addition, failure to have the child tested is aclass C misdemeanor.

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. There is nomention of an advisory committee; however, separate adhoc advisory committees exist for metabolic, endocrine,and hemoglobin conditions.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the physician attending a newborn orthe person attending the delivery of a newborn . . . notattended by a physician. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “the laboratory established by thedepartment or by a laboratory approved by the depart-ment. . . .” Regulations specify, “Analysis of the bloodspecimens . . . must [also] be performed by the depart-ment.”

What Additional System Components Does the Fee Cover?The fee covers laboratory testing only. The programoffers administration, follow-up services, and limitedtreatment if the child is ineligible for other state services.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.The person who administers the screening must place astatement of refusal, signed by a parent or guardian, inthe child’s medical record. The department is required bystatute and/or regulations to collect data on incidenceand prevalence rates of disorders from specimen formsand to maintain a roster of individuals diagnosed with adisorder. The department may cooperate with otherstates to develop a national roster of diagnosed individ-uals if information on incidence and prevalence rates ismade available to participating newborn screening pro-grams in other states. Programs participating in the na-tional roster would have to prescribe to an agreement toprotect the identity and diagnosis of the individuals in-cluded in the roster.

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority to makechanges, after consulting with the Genetic AdvisoryCommittee.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations state that, in an institution, “the institutionmust collect and submit an appropriate specimen”; out-side an institution, “the practitioner or other personprimarily responsible for providing assistance to themother at birth must arrange for the collection andsubmission of an appropriate specimen”; or, if there is noother person attending the birth, “the parent or legalguardian must arrange for the collection and submis-sion.”

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify the Department of Health NewbornScreening Laboratory.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.The person responsible for newborn screening must in-form the parent or guardian of required collection andsubmission of the specimen unless the infant is bornwithout an attendant. Under that circumstance, the par-

ent must obtain a newborn screening kit. If a parent orguardian declines screening, then a statement of refusalsigned by the parent or guardian, the reason for refusal,and information about educational materials provided tothe parent or guardian must be documented in the med-ical record. The practitioner or birthing institution mustsend a copy of the statement of refusal to the depart-ment. The department has access to medical records ofthe newborn, to identify why the practitioner failed tocollect a specimen or to obtain missing demographicdata. If a parent or guardian fails to comply with stateregulations, then the practitioner or birthing institutionmust report medical neglect to the department.

Vermont

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority. There is anonstatutory advisory committee.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?This is not mentioned in the regulations.

Are Newborn Screening Laboratory Services Regulated?How?The laboratory is not mentioned in the regulations. Cur-rently testing is provided through a contract with theUniversity of Massachusetts Medical School.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?A statute specific to newborn screening does not exist;however, the chronic disease statute acknowledges thatinformation on newborn screening disorders is reportedto the Department of Health. The department has stat-utory responsibility and authority “to develop an earlycase-finding program . . . concerning chronic diseases,”and this has been extended to include newborn screen-ing. According to state regulations, parents may object toparticipation in the newborn screening program for anyreason. The person who administers newborn screeningmust send a written statement of objection to the De-partment of Health. The program must operate understandards of practice accepted by the American Academyof Pediatrics, the CDC, and other recognized experts.

Virginia

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health has the authority. There is nomention of an advisory committee; however, a multidis-

ciplinary genetics advisory committee also advises onnewborn screening.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statutes states, “the physician, nurse, or midwife incharge of the delivery . . . or the first attending physi-cian. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute and regulations state, “The screening testsshall be performed by the Division of Consolidated Lab-oratory Services or any other laboratory the department. . . has contracted. . . .” Currently testing is performedby the Division of Consolidated Laboratory Services (thestate laboratory agency).

What Additional System Components Does the Fee Cover?In addition to testing, the program covers administra-tion, education, follow-up services, and limited treat-ment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.The person who administers newborn screening mustinclude a statement of written objection by the parent orguardian in the child’s medical record. All medicalrecords associated with newborn screening are confiden-tial. The Board of Health, the commissioner, and thecommissioner’s agents may access newborn screeningrecords. In addition, the Department of Health may re-lease newborn screening results for research and statis-tical purposes or with the explicit permission of a parentor guardian. Publications may not disclose identifiableinformation.

Washington

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The State Board of Health has authority. There is norequirement for an advisory committee; however, theboard convenes an advisory group as needed, with focuson the question(s) at hand.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “It shall be the duty of the Departmentof Health to require screening . . . before they [infants]are discharged from the hospital. . . .” Regulations state,“Hospitals providing birth and delivery services or neo-natal care to infants shall . . . obtain a blood speci-men. . . .” and “forward the specimen. . . .”

Are Newborn Screening Laboratory Services Regulated?How?Regulations require that specimens or signed refusals beforwarded “to the Washington State Public Health Lab-oratory no later than the day after collection.” Whenspecimens are received, “the department shall performappropriate tests for. . . .”

What Additional System Components Does the Fee Cover?In addition to testing, the screening fee covers adminis-tration, follow-up services, program evaluation, pro-gram monitoring, and education.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.The person who administers the screening must informthe parent or responsible party of the purpose of screen-ing, the disorders included, the requirement for new-born screening, and the right to refuse. If refusal occurs,then a signed statement of refusal must be obtained andforwarded to the state laboratory. The department maycontact the family directly if necessary, to communicatesignificant test results. Regulatory revisions approved bythe Board of Health address privacy, confidentiality, andthe use of residual samples.

West Virginia

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Commissioner of State Public Health has authority.There is no mention of an advisory committee; however,a nonstatutory, multidisciplinary, advisory group exists.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states, “the hospital or birthing center. . . the parents or legal guardians, the physician attend-ing the newborn, or any person attending a newborn notunder a physicians care. . . .”

Are Newborn Screening Laboratory Services Regulated?How?The statute states, “The Bureau of Public Health shallestablish and maintain facilities at its State HygienicLaboratory for testing specimens. . . .” Also, “the StateBureau of Public Health is authorized to establish addi-tional laboratories. . . .” Currently the State HygienicLaboratory performs testing.

What Additional System Components Does the Fee Cover?There is no fee.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.The person who administers screening must fully informthe parents of the purpose of the test and must providethe family with a reasonable opportunity to object. Withthe exception of anonymous statistical data, the WestVirginia Department of Health and Human Resourcesmay not disclose information obtained from a newbornscreening specimen or the parent or guardian of aninfant.

Wisconsin

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The Department of Health has authority and “shall seekthe advice and guidance of medical consultants, staff ofthe state laboratory, and other persons. . . .” There is nomention of an advisory committee; however, several adhoc committees advise the department regarding variousgroups of disorders and education.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?The statute states that the attending physician or li-censed nurse who attended the birth is responsible.

Are Newborn Screening Laboratory Services Regulated?How?The statute specifies the State Laboratory of Hygiene.

What Additional System Components Does the Fee Cover?In addition to testing, the fee covers administration,follow-up services, counseling, and treatment.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?All newborns must participate in newborn screeningunless a parent or guardian objects on religious grounds.The person who administers screening must fully informthe parents of the purpose of the test and must providethe family with a reasonable opportunity to object. Withthe exception of anonymous statistical data, or as per-missible under the state public health records statute, thedepartment may not disclose information obtained froma newborn screening specimen or the parent or guardianof an infant. The state public health records statute holdsrecords confidential and requires informed consent fordisclosure of information other than to the parent orguardian, with exceptions, including health care deliv-ery and research that protects the identity of the patient.The state newborn screening laboratory may conductadditional testing on specimens for the purpose of re-search on congenital or metabolic disorders, as long as

any applicable human research subject protections arefollowed. The laboratory also may test specimens for thepurpose of evaluation.

Wyoming

Who Has the Authority to Change the Panel of Disorders? Isan Advisory Committee Required?The statute specifies that a committee consisting of thestate health officer, the president of the state medicalsociety, a member designated by the state pediatric so-ciety, and a member designated by the obstetric/gyne-cological society shall determine the specific tests.

Who Is Responsible for Ensuring a Newborn Screen IsPerformed?Regulations specify the hospital, attending physician,midwife, or person attending the delivery.

Are Newborn Screening Laboratory Services Regulated?How?Regulations specify the “regional laboratory.” Currentlythe Colorado Department of Health Laboratory providestesting.

What Additional System Components Does the Fee Cover?Fees cover only laboratory costs.

How Are Consent, Confidentiality, and Other Privacy IssuesAddressed by Statute or Administrative Code/Regulation?The individual who administers newborn screening isrequired first to obtain the informed written consent ofa parent or guardian. If the parent or guardian objects forany reason, then the newborn is exempt from the pro-gram.

ACKNOWLEDGMENTSWe gratefully acknowledge the financial support pro-vided by the Genetic Services Branch, Maternal andChild Health Bureau, Health Resources and Services Ad-ministration, through cooperative agreement MC00148-05 with the University of Texas Health ScienceCenter at San Antonio.

We acknowledge the gracious support of the follow-ing people who reviewed and validated the informationpresented for each program: Alabama, Jean Norris;Alaska, Thalia Wood; Arizona, Ruthann Smejkal; Arkan-sas, Jackie Whitfield; California, Fred Lorey; Colorado,Jim Bebee; Connecticut, Dottie Trebisacci; District ofColumbia, Brenda Anderson; Delaware, Betsy Voss;Florida, Lois Taylor; Georgia, Mary Ann Henson; Hawaii,Christine A. Matsumoto; Idaho, Brett Harrell; Illinois,Claudia Nash; Indiana, Weilin Long; Iowa, Tonya Diehn;Kansas, Jane Steuve; Kentucky, Kristie Cook; Louisiana,Charles Myers; Maine, Eleanor Mulcahy; Maryland, Su-san Panny; Massachusetts, Roger Eaton; Michigan, Bill

Young; Minnesota, Mark McCann; Mississippi, JerryMcClure; Missouri, Julie Rayburn; Montana, Janet Bak-er; Nebraska, Julie Miller; Nevada, Gloria Deyhle; NewHampshire, Marcia Lavochkin; New Jersey, Suzanne Fi-cara; New Mexico, Wanda Yazzie; New York, Ken Pass;North Carolina, Lara Percenti; North Dakota, Karen J.Oby; Ohio, Bill Becker; Oklahoma, Pam King; Oregon,Cheryl Hermerath; Pennsylvania, Joanne Adair; RhodeIsland, Barbara McNeilly; South Carolina, Kathy To-mashitis; South Dakota, Lucy Fossen; Tennessee, MitzyLamberth; Texas, Eldridge Hutcheson; Utah, Fay Keune;Vermont, Cindy Ingham; Virginia, Sharon Williams;Washington, Sheila Neier; West Virginia, Barbara Eck-erd; Wisconsin, Gary Hoffman; Wyoming, Larry Good-may.

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DOI: 10.1542/peds.2005-2633C2006;117;S212Pediatrics

Bradford L. Therrell, Alissa Johnson and Donna WilliamsStatus of Newborn Screening Programs in the United States

ServicesUpdated Information &

http://pediatrics.aappublications.org/content/117/Supplement_3/S212including high resolution figures, can be found at:

References

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DOI: 10.1542/peds.2005-2633C2006;117;S212Pediatrics

Bradford L. Therrell, Alissa Johnson and Donna WilliamsStatus of Newborn Screening Programs in the United States

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the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,has been published continuously since 1948. Pediatrics is owned, published, and trademarked by Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it

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