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Status of Newborn Screening Programs in the United States

^a National Newborn Screening and Genetics Resource Center, Austin, Texas
^b National Conference of State Legislatures, Washington, DC

	ABSTRACT

TOP ABSTRACT METHODS RESULTS DISCUSSION CONCLUSIONS APPENDIX 3. SELECTED NEWBORN... REFERENCES

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

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

RESULTS. Included is a compilation of pertinent newborn screening statutes, information from genetic privacy statutes that potentially affects newborn screening programs, and a review of state laws that affect specimen and information retention. In addition, program policies related to the use of residual newborn screening blood spots are reviewed, along with the developmental processes affecting program informational brochures, including the information contained and the strategies for brochure dissemination.

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

Key Words: newborn screening • laws • education • public health • public policy

Abbreviations: PKU—phenylketonuria • HIPAA—Health Insurance Portability and Accountability Act of 1996 • NNSGRC—National Newborn Screening and Genetics Resource Center • CORN—Council of Regional Networks for Genetic Services • APHL—Association of Public Health Laboratories • CDC—Centers for Disease Control and Prevention

Newborn screening began in the early 1960s,^1,2 with the intent to decrease or to eliminate the catastrophic effects of preventable mental retardation.³ Special-interest advocacy led many states to enact legislation that required screening of all newborns for phenylketonuria (PKU). Early laws usually included funding for laboratory testing and related follow-up services. Government funding was justified on the basis of cost savings through avoidance of long-term institutionalization of patients with PKU in state-supported mental hospitals. Since then, all states and most territorial jurisdictions have incorporated mandated newborn screening for PKU into their public health preventive services.

Over the years, increased scientific and medical knowledge, coupled with technical advancements, has allowed newborn screening programs to expand in scope. Policy decisions governing US newborn screening activities have been reviewed by the National Academy of Sciences,⁴ the Institute of Medicine,⁵ the American Academy of Pediatrics,⁶ and others.^7–9 In some cases, a legislative mandate has defined the degree of program expansion; in other cases, expansion has occurred through changes in regulations or other mechanisms permitted in the enabling statute. Legislative approaches to newborn screening issues, such as consent requirements for testing, decision-making processes for testing for additional conditions, and mechanisms and extent of program financing,^6,10 also have varied. As newborn screening evolved into a comprehensive 6-part system,^9,10 policymakers struggled to keep pace with system complexities, and program variations arose.¹¹

As a necessary part of newborn screening, identifiable patient information is often available at birthing facilities, offices of health care providers associated with the patient, the screening laboratory, the state/territorial health department, and possibly confirmatory laboratories and subspecialty clinics, among others. Because newborn screening is included in the broader definition of genetic screening, genetics privacy laws may affect newborn-screening activities directly. In many instances, state/territorial governments have enacted legislation and established regulations providing for the confidentiality of individually identifiable genetic information. Often consent or refusal options have been included, to give individuals greater control over their personal information or that of their newborns. Depending on the language used in statutes or regulations, these options may apply to personal information or to specimens from which personal (genetic) information can be extracted, such as blood specimens. It is now the case that newborn screening programs must be aware of how they are affected not only by newborn screening statutes and regulations but also by other genetic privacy restrictions, including national laws such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA).¹²

To ensure that parents and health care providers who participate in newborn screening are knowledgeable about the screening system and their roles in it, programs devote considerable resources to education. As the number of conditions available for inclusion in screening increases steadily (and sometimes quickly), programs are faced with the need to provide timely accurate information to a host of different entities. Newborn screening programs have developed basic information for parents to address some of these educational issues. Demand for rapid production of new educational materials may not allow for adequate attention to preparation of materials (with respect to content, literacy, and cultural sensitivity), thoughtful distribution of materials, and assessment of the effects of materials. As part of this project, limited background information on distribution and content was obtained, to provide a basis on which to refine and to improve educational pamphlets for parents.

Newborn screening programs are also faced with issues regarding storage and management of residual specimens that remain after newborn screening tests are complete. Whereas previously these specimens were viewed as primarily useful for program quality assurance and perhaps as final testing material that could be reanalyzed in cases of late or misdiagnosed conditions, they have become increasingly important as possible sources for genetic research. This is of particular importance because newborn screening specimens represent the most comprehensive population testing program currently in operation, and specimens are obtained from essentially every newborn.

This article is intended to summarize the current state of affairs in critical areas in US newborn screening programs. We acknowledge that many activities are ongoing in the newborn screening arena, and we sought to take a snapshot of these activities in or around January 2005. This baseline information should prove useful as changes in newborn screening policymaking evolve in response to recent federal initiatives regarding selection of conditions for screening. Included in the article are various summation tables that describe the current status of testing, privacy, and educational activities. Legislation pertinent to these issues also is reviewed. Included are appendices that delineate important program information extracted from pertinent laws and regulations. To ascertain the extent to which programs have instituted policies for storage and future use of residual blood spots, this project investigated the simple question of whether policies exist currently and the role of privacy laws and regulations, if any, in current storage policies and practices. Program personnel acknowledged at the end of the report assisted in the validation of the information presented.

	METHODS

TOP ABSTRACT METHODS RESULTS DISCUSSION CONCLUSIONS APPENDIX 3. SELECTED NEWBORN... REFERENCES

 
Privacy and Confidentiality
To identify newborn screening laws and regulations and privacy laws and regulations pertaining to newborn screening, a computerized search of the Westlaw database was conducted with variations of the following terms: infant, birth defect, congenital, genetic, hereditary, infant, neonate, newborn, phenylketonuria, and screening. Therefore, this search was limited by the ability of the database to detect information and by the breadth of the search terms used. Each of the statutes and regulations identified was accessed, read, and evaluated for relevance to privacy and other policy issues. In addition, comparison was made to a summation of newborn screening laws reported previously,¹³ to ensure comprehensiveness of the information accessed. The latest available published national summation data on newborn screening¹⁴ were also reviewed for pertinent information on births, samples received, number of screens required or recommended strongly, and number of conditions mandated. Updated information on disorders included in screening programs was obtained from the National Newborn Screening and Genetics Resource Center (NNSGRC) through its online database.¹⁵

Individual newborn screening statutes and regulations were examined to identify confidentiality and consent requirements, to determine prescribed methods for selecting conditions for inclusion in newborn screening mandates, and to identify and to analyze provisions concerning the use and storage of dried blood spots. Newborn screening statutes that either specified confidentiality policies or required the health department to promulgate regulations to address confidentiality issues were noted. Statutes and regulations that required consent or written authorization as part of the screening process were also identified. Genetic privacy laws were analyzed to determine whether newborn screening or public health programs were exempted. Statutes that did not exempt newborn screening were reviewed to identify confidentiality and consent provisions that might apply to state public health employees who provide newborn screening services.

To validate and to update the regulatory information acquired, an e-mail message was sent to the person in each state identified as being most likely to have knowledge of the regulations (for names, see Acknowledgments). Responders were requested to validate and to update the interpretive data for their program, with specific emphasis on current statutes, regulations, and relevant policies. Nonresponding programs were contacted by telephone, and information was obtained from all 51 US newborn screening programs (50 states and the District of Columbia). These validated responses are included in the various tables and appendices of this report.

Educational Materials
To develop information about the process used by programs for educating parents and to provide baseline information for refining basic educational materials, a questionnaire was prepared and disseminated (Table 1). Because the most common form of newborn screening educational information for parents was thought to be pamphlets distributed prenatally or at birthing facilities around the time of delivery, questions focused on the information contained in such pamphlets and the mechanism for pamphlet dissemination. The questions used were suggested by newborn screening personnel as likely to provide useful information for comparison and improvement of the varied educational materials. Indeed, as part of the survey, 50 of 51 programs confirmed that they distributed educational pamphlets for (and, it is hoped, to) parents. The questionnaires were returned initially by almost all programs; the remaining programs were contacted by telephone and responses were obtained, so that all 51 US public newborn screening programs were represented by the data. Other pamphlets from private newborn screening programs were known to exist but were not included in this project.

To learn whether screening programs developed policies in response to earlier concerns and recommendations about storage and use of residual specimens, we conducted a survey of related program policies and activities in early 2003. A brief questionnaire (Table 2) was sent by e-mail to the newborn screening laboratory supervisor or another person at the program level identified as being most knowledgeable about specimen policies. Programs were asked to mail or fax copies of any regulations, policies, or standard operating procedures relating to specimen storage and use after initial newborn screening laboratory analysis. Programs that did not respond by e-mail were contacted by telephone, so that responses were collected from all 51 US programs.

	RESULTS

TOP ABSTRACT METHODS RESULTS DISCUSSION CONCLUSIONS APPENDIX 3. SELECTED NEWBORN... REFERENCES

 
Privacy and Confidentiality
Because there is no federal law regulating newborn screening, state and territorial statutes and regulations govern newborn screening program implementation within their respective jurisdictions. Currently laws exist that either mandate or allow for newborn screening in all states and the District of Columbia. Although it is desirable to confirm that every newborn obtains a newborn screening test, many programs are not yet able to provide this information because they do not have data integration between the newborn screening program and the vital records (birth certificate) program. Therefore, newborn screening data on the number of specimens received are used to provide approximations of program coverage. Basic information from the most recently published national newborn screening summary data,¹⁴ updated with current information on selected items taken from the NNSGRC Web site (http://genes-r-us.uthscsa.edu), are summarized in Appendix 1. These data include the number of births within the jurisdiction and the number of specimens received during 2001.

More-detailed information regarding testing and privacy statutes is given in Appendix 2, including statute references. Additional summary information about the various programs is presented in Appendix 3. Although not all states and territories have specific statutes regarding newborn screening, all programs cite statutes that either mandate or allow for newborn screening. As a result of these laws, most newborn screening occurs routinely at the birthing facility, with parents allowed only an opportunity to refuse screening (opt out) if they object. Thirty-three programs permit refusal of newborn screening on religious grounds, and 12 permit it for religious or other reasons. Five programs do not allow refusal, and the statute and regulations in New Hampshire are silent on the issue.

Typical information recorded on newborn screening specimen-collection devices includes the names of the newborn and the parent or guardian, their address and telephone number, a physician associated with the newborn, the infant's birth date, and limited other information.¹⁸ To protect individual privacy, 28 newborn screening statutes include some type of confidentiality provisions that restrict either the use of personal information or the access to actual blood spot specimens. Some states have additional measures to protect the privacy of personal information. For example, Texas law allows submission of newborn screening information to a national roster of newborn screening cases only if the identities of individuals in the roster are protected. Minnesota and Oregon allow a parent or guardian to suggest corrections after examining a child's newborn screening record. Only laws in California, Maryland, Minnesota, and Oregon acknowledge specifically the right of individuals to have access to personal information maintained by the health department and obtained through newborn screening.

Nineteen states/territories have statutes and regulations that permit researchers to access and to use newborn screening information for scientific studies, and 10 of these have laws or regulations that include specifically access to specimens (Appendix 1). In general, research involving specimens or identified patient information requires review by an institutional review board, and restrictions on sharing information, sometimes including publication restrictions, may be required. In all programs that permit research on residual dried blood spots explicitly, researchers are required to protect the confidentiality of patient information.

Genetic information was found to be defined explicitly as personal property in 5 states, ie, Alaska, Colorado, Florida, Georgia, and Louisiana. (Currently Alaska is the only state extending this property right to DNA.) Generally it is held, however, that parties involved in the newborn screening process, such as laboratory personnel, health department personnel, and primary care physicians, are permitted access to individually identifiable information for service delivery or for birth defect tracking and monitoring. In these circumstances, individuals or entities acting as part of the newborn screening process may exchange personal information.

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

Thirteen states (California, Delaware, Florida, Georgia, Idaho, Indiana, Maine, Michigan, Mississippi, Oregon, South Carolina, Tennessee, and Utah) have specific penalties for the violation of state newborn screening laws or regulations. Punishments for violating the privacy of newborns screened or failure to maintain the confidentiality of newborn screening specimens and results range from establishment of grounds for filing a complaint against the relevant state licensing board (in Indiana) to up to $250000 in damages and reasonable attorney fees (in Oregon). A violation of newborn screening laws or regulations in states with criminal penalties is a misdemeanor, with the exception of Utah, where the hospital or practitioner must report medical neglect to the state if a parent fails to comply with state laws or regulations. In Nebraska, the attorney general or the county attorney may enforce the law through a civil proceeding if a parent fails to respond to a report of a presumptive positive screening test.

Educational Materials
A review of statutes and regulations that affect education showed 20 programs (Appendix 2) with requirements for health department personnel or other individuals involved in newborn screening to provide specific information to a parent or guardian before screening takes place. Requirements included the provision of oral or written information, or both. Educational items identified varied but included information on the right to refuse screening, the panel of newborn screening disorders, the consequences of treatment or nontreatment, the need for follow-up testing, retention and storage of samples, and confidentiality and privacy issues. Interesting issues were sometimes raised by the use or omission of wording in the statute. In Arkansas, for example, the health department must "disseminate information and advice to the public concerning the dangers and effects of phenylketonuria, hypothyroidism, and sickle-cell anemia," but the education is not required specifically before newborn screening. In Nebraska, the health department is required to develop an educational brochure, but how or when it should be distributed is not included. Kansas regulations require prenatal care providers to "discuss and distribute written material describing the newborn screening program."

Follow-up coordinators from all 51 US newborn screening programs responded to our questionnaire regarding preparation and dissemination of educational pamphlets for parents (Table 3). One program responded that it lacked such a pamphlet and was working on its development. Of the 50 programs with a newborn screening pamphlet, 10 programs (20%) reported that distribution was a usual activity of obstetricians; 14 programs (27%) reported that pamphlet distribution was a usual activity of prenatal classes. Although it is thought that most birthing facilities distribute program information pamphlets as part of their information packets for new mothers, only 19 programs (<40%) reported having a mandate for such distribution.

Residual Specimen Storage and Usage
During 2001, US screening programs reported receiving almost 5.3 million specimens for analysis.¹⁴ The number of specimens received was 33% higher than the reported number of births, in part because 8 programs required 2 specimens for every newborn (1 obtained before hospital discharge and 1 obtained 2 weeks later), and each reported >90% compliance. Several other states strongly recommended a second specimen, to the extent that compliance exceeded 80%; essentially all remaining programs required a second sample when the first was obtained too early (defined as before 24 or 48 hours of age, depending on the program), and all reported receiving some repeat specimens.

Because laboratory protocols, as well as specimen storage and later use, can affect whether a second specimen is obtained, it is useful to review the various laboratory service models operating currently within the country (Fig 1). In situations where 1 laboratory serves multiple states, it is not necessarily the case that all states served screen for the same conditions. For most jurisdictions, newborn screening is performed as part of the services of the jurisdiction's public health laboratory; for a few, screening is contracted to other laboratories (public or private), usually through competitive bidding. Several of the northwestern states, Hawaii, and Alaska use the services of the Oregon State Public Health Laboratory, Wyoming contracts with the Colorado Department of Public Health and Environment, North Dakota contracts with the Iowa University Hygienic Laboratory (the Iowa public health laboratory), and most of the New England states use the laboratory at the University of Massachusetts Medical School (affiliated with the Massachusetts Department of Public Health). The Indiana program contracts with the Indiana University Medical School, and the Arizona program contracts with the Arizona Department of Public Health Services laboratory (through competitive bidding).

View larger version (51K): [in this window] [in a new window]   FIGURE 1 Different models for newborn screening laboratory services within the United States. Hospitals in Pennsylvania may choose either the University of Massachusetts Medical School Laboratory or Pediatrix Screening, Inc, also used by Nebraska, Mississippi, and the District of Columbia. Hospitals in Louisiana and Maryland also may choose to use the state public health laboratory or to contract with other screening laboratories. Subcontracts also exist in South Dakota such that tandem mass spectometry screening is provided by the Institute for Metabolic Disease in Dallas and cystic fibrosis testing is provided by the University of Massachusetts Medical School laboratory.

Results indicate that 9 states (Appendix 1) have specific statutory or regulatory requirements for the retention of newborn screening information and specimens. The prescribed retention periods vary from 1 month to indefinitely. In some state/territorial jurisdictions, parents can choose whether to request the return or destruction of a sample or to continue its storage for research purposes after a specified time interval (eg, 2 years in South Carolina and Minnesota). Florida, Idaho, and Ohio have requirements relating to retention of newborn screening records that do not specify whether the specimens themselves are included as a record. Laws and regulations in California, Maine, and Washington declare newborn screening samples to be the property of the state; however, in Maine a parent is permitted to object to state ownership in writing. The remaining programs seem to be able to destroy or to retain newborn screening samples and information as long as they are compliant with general record-retention and sample-storage laws or regulations and internal departmental policies.

Our survey of newborn screening laboratory practices (Appendix 1) found that 37 programs have written policies regarding the storage of newborn screening dried blood spots after completion of the newborn's screening tests, leaving 14 programs with no policy. Storage practices were variable, with 24 programs reporting storage times of 6 months, in contrast to 8 programs that reported indefinite storage. Of the remaining 19 programs, 6 stored specimens for 1 year, 7 stored specimens for 2 to 7 years, and 6 stored specimens for 21 to 23 years. Although it was not requested specifically, 2 states reported saving specimens from diagnosed patients for longer periods, compared with their routine specimens. Twenty-three programs reported having policies governing the use of residual newborn screening specimens, leaving 28 programs with no written usage policy.

	DISCUSSION

TOP ABSTRACT METHODS RESULTS DISCUSSION CONCLUSIONS APPENDIX 3. SELECTED NEWBORN... REFERENCES

 
Laws and Regulations
All 51 US newborn screening programs identified legal mandates that either provide specifically for the establishment of a newborn screening program or allow a newborn screening program to be created under a broader health mandate. The newborn screening statutes and related policies seek to balance the rights of individual autonomy with the overall public good in determining whether screening should be voluntary or mandatory. Confounding the issue are considerations about the well-being of the child versus the family's decision-making rights and the fact that many newborn screening conditions have rapid severe consequences if left undetected and untreated. The result is considerable variation in opinions about the need for consent for a mandated screening program and the decision in 2 states and the District of Columbia to allow parents the opportunity to consent to newborn screening. Although most of the other states allow parents an opportunity to opt out of newborn screening, primarily for religious reasons, it is interesting that 5 programs do not allow for refusal. In Nebraska, the state's right not to allow refusal of required testing was upheld recently by the Nebraska Supreme Court. In programs where additional newborn screening tests are available but not mandated, there is usually a consent or refusal option. An option to participate is also the usual case when new screening tests are offered as part of a research protocol or in a pilot study to determine testing feasibility.

Related to the issues surrounding consent and refusal are the issues of genetic privacy and adequate and appropriate parental education in the decision-making processes. In addition to statutes and regulations that address newborn screening privacy specifically, broader health laws, regulations, or policies may affect newborn screening programs. In particular, general public health and genetic privacy measures may establish consent, confidentiality, or other privacy protections that apply to public health programs generally or to anyone who might use the genetic information identified by the program. Whether privacy restrictions apply depends on the type of information and the specific features of the situation in question. Privacy and confidentiality protections typically are strongest in cases where personal identity is readily available. Laws or regulations may have fewer safeguards for unlinked or encrypted information, because a layer of protection exists between the identity of the patient and the personal information or the newborn's specimen.

The sharing of patient information for public health program purposes, including newborn screening, is often exempted from general health privacy laws and regulations. For example, the Department of Health and Human Services Standards for Privacy of Individually Identifiable Health Information require health plans, health care providers, and other entities covered by HIPAA to provide patients with greater control over their personal health information. HIPAA rules¹² allow specific exceptions for public health agencies and permit disclosure of individually identifiable health information to authorized public health agencies without consent "for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention."²⁰ In the case of newborn screening, public health personnel have access to personal information and are considered HIPAA exempt when delivering newborn screening services, including follow-up testing and related medical and public health assistance. In cases where research involves the use of newborn screening information or specimens, generally institutional review boards govern the degree of informational privacy. Federally funded anonymous or unlinked research is exempt from HIPAA rules and other federal regulation under the Common Rule, which establishes pertinent human subject protections.^21,22

Nearly all states have laws or regulations that protect the privacy and confidentiality of personal information collected and stored by state public health departments.²³ Typical methods of securing such information include access restrictions and specific limitations on information disclosure and use. Public health privacy laws and regulations may also stipulate different privacy requirements for different types of information. Because anonymous or unlinked statistical information is usually considered to be public record, a health department may be required to deidentify or unlink information shared in this way. Although it increases personal information protection, unlinking data for such purposes usually increases program costs, because of the time and effort required to meet these privacy requirements.

Although statutes and regulations pertaining to birth defects registries were not specifically researched for this report, newborn screening programs might be affected by such statutes and regulations when there are linkages between the 2. General public health privacy laws and regulations usually safeguard the information accumulated in birth defects registries, which often is used for research into the prevalence and causes of birth defects. Of the 45 states with an operational or developing birth defects registry,²⁴ most have laws that provide special privacy and confidentiality protections for case-specific demographic information. Generally these laws restrict access, limit disclosure, and specify the purposes for which researchers may use registry information. Generally exceptions, when they exist, allow public health personnel to access identifiable information to offer follow-up services or to request an affected child's participation in a research study.

Education
The need for sound education for parents and health professionals is well understood by newborn screening programs, and most report having some components of an education program in place. The most basic parent information is contained in program brochures intended to provide easy access to fundamental program information for parents. Basic information for health professionals is contained in a widely disseminated specimen-collection videotape.¹⁸

Our study of current program practices showed that parent education materials may be shared at a nonoptimal time for education (eg, after delivery).²⁵ It is agreed generally that prenatal newborn screening education is a more opportune way to provide the needed information about the screening experience. The need for prenatal education is acknowledged specifically in the Kansas regulations, which require prenatal providers to provide newborn screening education. Surprisingly few programs (20%) reported that distribution of educational pamphlets about newborn screening was a usual activity of obstetricians, and only slightly more (30%) reported that it was a usual activity of prenatal classes. These low rates illustrate the lack of involvement in newborn screening programs that obstetricians have had traditionally, although in some programs the law may assign the responsibility to ensure newborn screening to the "person attending the birth of the newborn." Similarly, although newborn screening advisory committees often include pediatricians and family practice physicians, they often overlook the benefits that could be obtained by including an obstetrician on the committee. As determined from information obtained from newborn screening program reviews, the most common method for providing educational information about newborn screening is through information packets provided as part of the overall information/education process for new parents. Obstetricians represent a potentially more effective and efficient means of transmitting information to large numbers of women, who could benefit from having the information before they arrive at the hospital for the birth and subsequent screening of their newborns.²⁶ Efforts to include the obstetrics community in newborn screening activities, particularly education, seem to be a pressing need for most newborn screening programs.

Retention and Storage
Procedures and policies for the management of the residual dried blood spots that remain after newborn screening continue to vary widely. Despite extensive discussions over time, the issues surrounding long-term specimen management have not resulted in consensus solutions. Even the seemingly simple question of how long to store the residual specimens is not resolved. Our survey indicated that, at the time, almost one half of the programs (23 of 51 programs) stored residual specimens for 6 months, whereas slightly more than 25% (14 of 51 programs) stored them for 21 years. These results compare favorably with a similar study of APHL members (all state and territorial health department laboratory directors) in 2002.¹⁷

The complexity of the storage issue revolves around the fact that, although the residual specimens remaining after newborn screening may provide usable specimens for some analyte tests when stored for long periods, the validity of the specimens for some tests is questionable or not satisfactory. However, the DNA contained in the specimen seems to be stable indefinitely. DNA analysis cannot be relied on to provide confirmation of initial newborn screening results, for various reasons (eg, multiple mutations associated with the condition or poor genotype/phenotype correlation), and generally the specimens that are stored for long periods (beyond a few months) are not considered useful for quality assurance regarding the original screening tests (with limited exceptions). Therefore, it is agreed generally that specimens stored for long periods are of interest primarily for their potential research use. This use is made more complex by the fact that most newborn screening programs do not need to obtain consent for testing; therefore, the use of specimens beyond the newborn screening procedure itself raises various legal and ethical questions.

The storage and usage issues related to residual blood spots after newborn screening were discussed at some length in a report from CORN.¹⁶ The CORN report also recommended that screening laboratories should develop policies for storage and use of the residual spots. Our survey indicated that 25% of screening laboratories (14 of 51 laboratories) still do not have written policies regarding storage, and more than one half (28 of 51 laboratories) reported having no written policy regarding usage. When these data were pursued, in many cases program personnel reported handling requests for access to residual specimens on a case-by-case basis and noted that requests for residual specimens had been minimal or had not been encountered. However, many programs reported several requests annually, primarily related to additional analyses to determine the cause of death in cases of sudden infant death syndrome or in other unusual circumstances in which a cause was not readily apparent. Occasional anecdotal requests for use of specimens for forensic purposes were also reported (eg, positive identification of infants when no other means of identification were available).

Despite the variations in program policies, regulations, and laws that might affect the storage and use of specimens, the potential for research use of population screening specimens is extensive. The CDC, in cooperation with APHL, convened a small working conference in September 2002 to discuss the possibilities for research use of these specimens, including the possibilities for consolidating specimens from programs to provide larger collections of available specimens for possible research. As might be expected, the tremendous variations in program approaches to the issues surrounding the use of residual specimens seemed to present a significant barrier to specimen consolidation. Nonetheless, conference participants seemed to embrace the possibilities of a virtual bank of specimens in which a data manager would maintain information regarding specimen availability for research, storage conditions, and limited other specimen information, such that an inquiring researcher might be directed to appropriate specimens for anticipated projects. However, before such a system is put in place, it will be necessary to address the considerable concerns related to privacy and consent. If these barriers can be overcome, then it may be possible to create a virtual national centralized specimen management system that would be useful for various types of research. Other ethical, legal, and social issues related to the question of using residual newborn screening specimens remain, and it seems that extensive use of newborn screening specimens accumulated nationally for research purposes outside the newborn screening process itself is not likely in the near future.

	CONCLUSIONS

TOP ABSTRACT METHODS RESULTS DISCUSSION CONCLUSIONS APPENDIX 3. SELECTED NEWBORN... REFERENCES

 
Newborn screening represents a successful population genetic screening program. The fact that a national newborn screening law or financing scheme does not exist in the United States leads, at least in part, to the current state of variation from program to program. Different legislative and regulatory approaches, coupled with a range of policies and practices, create a complex diversity of available services, consumer and professional involvement, and quality of components of the individual newborn screening systems.

Policymakers in states or territories that have yet to address definitively the issues discussed in this article may want to consider whether these issues might best be developed statutorily, through rule-making adjunctive to statutes already in place, through program policy changes, or through some combination of these approaches. Statutes or rules may provide a stricter means of enforcement and a more visible assurance to the public that government has taken action to alleviate concerns about privacy, confidentiality, and services. However, allowing program personnel the flexibility to create and to implement policies may provide a mechanism for faster reactions to change as technology and medical knowledge advance. Increased input from health care professionals involved closely and regularly with the newborn screening system can provide an increased sense of community ownership and involvement, with better responses to local needs and concerns. The information synthesized in this article should find use in comparative analyses between programs and across time as programs continue to be refined on the basis of new science and new national recommendations.

	APPENDIX 3. SELECTED NEWBORN SCREENING PROGRAM SUMMARY INFORMATION

TOP ABSTRACT METHODS RESULTS DISCUSSION CONCLUSIONS APPENDIX 3. SELECTED NEWBORN... REFERENCES

 
Alabama
Who Has the Authority to Change the Panel of Disorders? Is an 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 a geneticist advises the department.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states, "It shall be the duty of the administrative 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 ... shall be 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 Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in newborn screening unless the parents object on religious grounds. Newborn screening statutes or regulations do not require the hospital or birthing center to provide a parent or guardian with educational materials before the refusal of screening, and parents are not obligated to provide a written statement of refusal. If a newborn testing positive for a newborn screening disorder is not receiving care, then the department is permitted to contact the child's parent or guardian directly. There is no specific consent or confidentiality requirement for newborn screening or the use of residual dried blood spots, although general public health statutes and regulations may apply.

Alaska
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The statute gives authority to the Department of Health and Social Services. Regulations state, "The department will appoint a committee ... to consider addition and deletion of tests. ..." A multidisciplinary advisory committee has been established and is active.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states, "A physician who attends a newborn child. ... In the absence of a physician the nurse who first visits the child shall cause the test to be performed."

Are Newborn Screening Laboratory Services Regulated? How?
Regulations state, "The screening ... must be performed in a single laboratory designated by the department." Currently screening is contracted to the Oregon Department of Health Laboratory.

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

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
The parent or guardian of a newborn may decline to participate in the program. Grounds for refusal are not specified; however, the attending physician or nurse must inform the Department of Health and Human Services of the decision, and a signed statement of refusal is required. Alaska regulations specify that information obtained through newborn screening is a "confidential medical public health record" and is exempt from the public records statute. Individuals and facilities that generate the information must protect it from loss, tampering, and unauthorized access.

Arizona
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The statute states, "Tests shall be specified by rules of the Department of Health Services ... consistent with the recommendation of a newborn screening program committee. ..." The committee is chaired by the director of the department and includes 5 physicians from medical specialties in endocrinology, pediatrics, family practice, and obstetrics.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states, "The attending physician or other person required to make a report on the birth shall order ... tests for metabolic disorders."

Are Newborn Screening Laboratory Services Regulated? How?
The statute states, "The newborn screening program committee shall prepare and issue a solicitation ... to contract for the testing. Proposals may be accepted from hospitals, clinical laboratories, the state laboratory, and any other qualified public or private persons." The administrative code defines the newborn screening laboratory as "an entity contracted with the department to perform the newborn screening test." Currently the Department 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, and staff.

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
The parent or guardian of a newborn may decline to participate in the program. Grounds for refusal are not specified. Health care providers must report that the test was refused on the specimen collection form, submit the form to the Department of Health Services, and document the refusal in the patient's medical record. Arizona regulations do not require a signed statement of refusal from a parent or guardian. Before the collection of a specimen, health care providers must explain the purpose of the test, on the basis of the information contained in departmental educational materials available to providers for distribution to parents. The newborn screening regulation provides for the confidentiality of newborn screening results, subject to the general public health privacy statutes, which prohibit disclosure of confidential information without the written consent of an individual, a parent or guardian of a minor, or a spouse or legal representative of a deceased individual. The department may disclose confidential information for scientific research or legal proceedings.

Arkansas
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Department of Health has authority. There is no mention of an advisory committee; however, a multidisciplinary nonstatutory advisory committee is active.

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

Are Newborn Screening Laboratory Services Regulated? How?
Statute requires the Department of Health to establish a central laboratory. Regulations specify, "Specimens shall be submitted to the Division of Public Health Laboratories."

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

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in newborn screening unless the parents object on religious grounds. The newborn screening laws and regulations do not require a record of refusal. The Department of Health must educate the public about "the dangers and effects of phenylketonuria, hypothyroidism, and sickle cell anemia." There are no specific requirements concerning consent or parental education before collection of the blood sample or refusal of screening. The department must track diagnosed cases for program evaluation and operational purposes and may provide individually identifiable information about diagnosed cases to clinical or research programs with the permission of the infant's parent or guardian.

California
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Department of Health has authority. There is no mention of an advisory committee, but legislation is pending.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
Regulations state, "Birth attendants, laboratories, and hospitals shall collect specimens. ..."

Are Newborn Screening Laboratory Services Regulated? How?
The statute states, "The department may provide laboratory testing facilities or contract with any laboratory it deems qualified. ..." Currently there are 8 contract laboratories located regionally, with oversight from the Department 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 Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in the program unless the parent or guardian objects on religious grounds. The California Department of Health Services must allow a parent or guardian a reasonable opportunity to object on religious grounds. State regulations require that the physician or birth attendant include a signed written refusal of newborn screening in the infant's medical record. Birth attendants must provide parents with the department's educational brochure, Important Information for Parents, during prenatal care and in the hospital before childbirth or collection of the blood sample. Information obtained from individuals through newborn screening, including test results, is confidential, but all other information pertaining to the program is public record. The statute provides for individual access to test results and personal information generated through newborn screening. Positive test results must be reported to the health care provider. With written consent of the parent, guardian, or individual, if older than 18 years, the department may release individually identifiable information. The written consent is compliant with HIPAA and must include the scope of the information requested, the parties requesting the information, and the purposes for the release. An institutional review board approves informed consent for the written disclosure of personal information for research purposes. Newborn screening blood spots and related information are the property of the State of California. The state may use the specimens and information for program evaluation or research by the department or department-approved scientific researchers, provided the confidentiality requirements described above are met. The department must translate all forms or brochures referenced in state newborn screening regulation to the native language of the parent or guardian if necessary. State statute provides that an individual may receive compensatory and civil damages not greater than $10000, in addition to attorney fees and the cost of litigation, for a breach of confidentiality by the program.

Colorado
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Board of Health has authority. A nonstatutory advisory committee makes recommendations.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states, "The physician, nurse, midwife, or other health professional attending a birth ... shall be responsible for the collection. ..."

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

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

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in the program unless the parents object on religious grounds or have a personal objection to the administration of tests or treatment. All information other than statistical data is confidential. Informed consent is required for disclosure of individually identifiable information.

Connecticut
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Commissioner of Health has authority. There is a nonstatutory advisory committee.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
Responsibility is given to "the administrative officer ... in charge of each institution caring for newborn infants. ..."

Are Newborn Screening Laboratory Services Regulated? How?
Regulations state, "Specimens shall be submitted to the ... State Department of Health, or to a laboratory approved for the purpose. ..." Currently the Department of Public 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 Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in the program unless the parents object on religious grounds. If a parent declines to participate, then the individual offering screening must report the refusal to the Department of Public Health and place a signed statement of refusal in the infant's medical record. The department must direct diagnosed newborns to treatment centers in a manner consistent with confidentiality requirements. State regulations require that identifying information accompany each specimen for future reference, but they do not comment on specimen storage. The Department of Public Health must maintain newborn screening records for 5 years. These records must include the tests performed and results. The regulations do not mention blood spot storage. Currently blood spot specimens are discarded after 6 months.

Delaware
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
Regulations state, "as recommended by the Delaware Newborn Screening Program with the approval of the Director of the Division of Public Health." There is a nonstatutory multidisciplinary committee that advises the program.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The regulations state, "in order of responsibility: the hospital, alternate birth facility, or other licensed health care facility, the newborn's primary care provider, the parent or legal guardian."

Are Newborn Screening Laboratory Services Regulated? How?
Regulations state, "the laboratory designated by the Division of Public Health." Currently the Division of Public Health 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 Issues Addressed by Statute or Administrative Code/Regulation?
There is not a state statute pertaining to newborn screening per se; however, reporting requirements under the state's birth defects surveillance system and registry statute (see citation above) include biochemical abnormalities, and the state Board of Health has exerted its authority to adopt regulations for newborn screening under the state statutes requiring the Department of Health and Social Services to protect the well-being of mothers and children. The state is in the process of revising its regulations. Regulations require all newborns to participate in the state newborn screening program unless a parent or guardian objects on religious grounds. Families who decline testing must file an affidavit swearing their religious beliefs. The person who administers screening must provide an informational pamphlet developed by the department. The department must record demographic information on newborns screened, for surveillance and monitoring. Under state statutes, individuals or institutions who believe in treating illness through prayer are not required to participate in the birth defects surveillance system, which includes newborn screening information. A parent or guardian also may refuse to disclose personal information concerning an infant's birth defect on religious grounds. In addition, the department may not compel an individual to participate in "medical or public health examination, treatment, or supervision." The birth defects registry statute protects the confidentiality of information related to the diagnosis or treatment of a biochemical disorder reported to the department and prohibits the disclosure of individually identifiable information. The Department of Health Services is permitted to share personal information in the registry with authorized agencies. Newborn screening regulations state that all newborn screening records are confidential. Release of summary, statistical, or anonymous information is permitted. The department may release data for approved research projects. The type of data that may be released is not specified. A violation of state newborn screening regulations is punishable 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? Is an Advisory Committee Required?
The statute allows the mayor to add or to delete disorders on the advice of the Committee on Metabolic Disorders. Established by statute, this committee (9 members appointed by the mayor, ie, 4 consumers, 4 physicians including a geneticist or endocrinologist, and the director of the Department of Human Services) must consider, among other issues, the medical, psychological, ethical, social, and economic effects of programs to identify and to treat metabolic disorders.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
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 the mayor. ..." 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 by the contracting laboratory.

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
Participation in the District of Columbia newborn screening system is voluntary. Hospitals and birthing facilities must inform parents of the availability and purpose of tests. Parental consent for newborn screening is required. Parents may decline to participate in the program. Hospitals and birthing facilities are required to document consent or nonconsent in the infant's medical record. The District of Columbia statute prohibits discrimination against or stigmatization of carriers of metabolic disorders. All information gathered through the newborn screening process is confidential medical record except for deidentified statistical data. The department may disclose personal information with parental consent; however, the department must first explain the scope of the information requested and the purpose of the disclosure.

Florida
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Department of Health has authority, "after consultation with the Genetics and Infant Screening Advisory Council. ..." Council members include 2 consumers, 3 practicing pediatricians, 1 representative of each of 4 medical schools, the Secretary of Health (or a designee), and representatives from 2 department child health programs.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
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 Department of Health Laboratory performs testing.

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

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
Parents may refuse to participate in newborn screening for any reason. The refusing parent must sign a written refusal, to be given to the physician or person administering screening. The Florida Department of Health must maintain a confidential registry of infants testing positive in newborn screening, for delivery of services, administration of the program, and epidemiologic studies. The department must safeguard the information sufficiently to ensure the confidentiality of individuals in the registry, which is exempt from the public records statute. The newborn screening statute references specifically general health records statutes, which prohibit the release of any record by department personnel without consent. The laboratory must maintain records of screening results and follow-up testing for 3 years. Specimen storage is not addressed. A violation is punishable as a misdemeanor, 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? Is an Advisory Committee Required?
The director of the Division of Public Health must "seek the advice and guidance of the Newborn Screening Advisory Committee." A multidisciplinary committee of professional and consumer representatives with knowledge and expertise in newborn screening programs is mandated by regulation.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
Regulations note that the physician attending the newborn must "have a specimen ... taken before ... discharge." For nonhospital births, the person in charge of the facility must supply written notice to the parents.

Are Newborn Screening Laboratory Services Regulated? How?
Regulations state "a laboratory approved by the Department of Human Resources. ..." Currently the Division of Public Health Laboratory provides all testing.

What Additional System Components Does the Fee Cover?
There is no fee, but the statute defines a 5-component system, ie, "screening... ; retrieving potentially affected... ; diagnosis;... therapy;... assessing programs."

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in the program unless the parents object on religious grounds. If an infant's physician is unable to reach the parents regarding test results, then the local health department may contact the family directly. Violations of the regulations are punishable as misdemeanors.

Hawaii
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Department of Health has the authority. An advisory committee is not required; however, there is a Newborn Screening Advisory Committee that meets 1 or 2 times each year and more often if needed.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states, "the person in charge of each institution ... physician attending the birth ... person assisting the birth of a child not attended by a physician. ..."

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

What Additional System Components Does the Fee Cover?
The statute allows the fee to be used for "the payment of its lawful expenditures, including but not limited to laboratory testing, follow-up testing, educational materials, continuing education, quality assurance, equipment, and indirect costs." The fee is used to pay for the salaries and fringe benefits of the newborn screening program staff members; FedEx overnight courier services; specimen collection and handling charges; a contracted nutritionist, pediatric endocrinologist, and metabolic specialist services; and newborn screening services for the indigent.

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in the program unless the parents, guardians, or other persons having custody or control of the child object on religious grounds. The Hawaii Department of Health must distribute an informational brochure about newborn screening to parents and all individuals and institutions involved in the process. If parents, guardians, or other persons having custody or control over the child refuse screening, then the person overseeing the screening process must explain the medical implications of refusal to the family, include a written objection in the patient's medical record, and send a copy of the written objection to the department. Hawaii statutes require the Department of Health to adopt rules regarding the retention of records and related data, educating parents, and confidentiality. Accordingly, state regulations require that laboratories store specimens so that retesting is possible for 1 year and that they develop a system to log and to track specimens. The department also must make an informational brochure available to parents. The newborn screening program and physicians consider all information, including records, correspondence, and individually identifiable information, confidential. The department may use such information only for the purposes of medical intervention, counseling, scientific research, or fulfilling reporting requirements, while keeping the name of the patient confidential at all times. The newborn screening regulations refer to Hawaii's general medical records statute, which requires public agencies to store records for 7 years after the individual who received services reaches the age of majority; however, public health screening is exempt.

Idaho
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The director of the Department of Health and Welfare has authority. There is no mention of an advisory committee, and none currently exists.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states, "It shall be the duty of the administrative officer ... or the person responsible for the registration of the birth... .

Are Newborn Screening Laboratory Services Regulated? How?
Regulations state, "The department shall provide access to newborn screening laboratory services." It goes on to describe duties for "all laboratories receiving dried blood specimens on infants. ..." Currently the Oregon Department of Health Laboratory performs laboratory testing.

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

How Are Consent, Confidentiality, and Other Privacy Issues Addressed by Statute or Administrative Code/Regulation?
All newborns must participate in newborn screening unless the parents object on religious grounds. State newborn screening regulations refer to general Department of Health and Welfare rules concerning medical records, which require written authorization for use and disclosure of health information outside the department. The form must specify the type of information requested, as well as the intended purpose and the user. The administrator of the responsible institution or birth registrant 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 all infants with PKU and other preventable diseases and must oversee the local health department's treatment of individuals with disease. Under state statutes, a violation of newborn screening regulations is punishable as a misdemeanor.

Illinois
Who Has the Authority to Change the Panel of Disorders? Is an Advisory Committee Required?
The Department of Public Health has authority. Regulations specify an advisory committee to advise on the selection of consultants to work with subprograms within the newborn screening program.

Who Is Responsible for Ensuring a Newborn Screen Is Performed?
The statute states that primary responsibility lies with the "physician on attendance at or immediat