Skip to Page Content
Delaware.gov  |  Text OnlyGovernor | General Assembly | Courts | Elected Officials | State Agencies
 Photo: Featured Delaware Photo
 
 
 Phone Numbers Mobile Help Size Print Email

Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMay 2013

Table of Contents Previous Next

Authenticated PDF Version

(16 Del.C., §122(1), §122(3)h and §7904)
16 DE Admin. Code 4107
On February 1, 2013 (Volume 16, Issue 8), DHSS published in the Delaware Register of Regulations its notice of proposed regulations. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by March 4, 2013, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
The Birth Center, Kathleen McCarthy and Dorinda Dove, Co-Owners, Co-Directors:
Agency Response: The Agency appreciates and acknowledges these comments. While we realize that freestanding birth centers and nurse midwives who perform home deliveries may be impacted by the implementation of pulse oximetry screening, these groups will have the option to either perform the screening at the home visit within 72 hours after birth or refer an infant to the primary care provider for screening.
Agency Response: The Agency appreciates and acknowledges these comments, however for the purposes of these regulations, third party payment issues for professional/medical services are not addressed and we respectfully decline to comment on this issue.
American Heart Association, Julie Brackett, Vice President of Advocacy
Agency Response: The Agency appreciates and acknowledges these comments, however we respectfully disagree. We feel that the language, as it stands already charges the Division of Public Health with oversight of this screening requirement. The Newborn Screening Program Medical Director will ensure that training for pulse oximetry screening is provided to those facilities that request such assistance.
State Council for Persons with Disabilities, Daniese McMullin-Powell, Chairperson
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has changed the section to read, “The purpose of these regulations is s to describe the procedures for the Newborn Screening Program where each newborn delivered in the state must be provided a panel of screening tests to identify metabolic, hematologic, endocrinologic and certain structural disorders that may result in developmental delay, cognitive disabilities, serious medical conditions, or death.”
Second, in the same “sentence”, SCPD recommend deletion of the word “certain” between “identify” and “metabolic”. Compare comparable provisions in title to §4.0, §4.1, and 6.1. The definitions of “endocrinologic disorder”, “hematologic disorder”, and “metabolic disorder” are not restrictive. Indeed, the definition of “metabolic disorder” refers to “include, but are not limited to...”.
Agency Response: The Agency appreciates and acknowledges these comments. The word certain has been removed before “metabolic.”
Agency Response: The Agency appreciates and acknowledges these comments. We have made the terminology consistent and have replaced “institution” with “facility” throughout the regulations.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has changed “result” to “results.”
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has added “health” to read “primary health care provider.”
Sixth, §6.1.1 refers to “no later than 3 days after birth...” The strikeout of “3" results in a confusing reference.
Agency Response: The Agency appreciates and acknowledges these comments. The word “three” has been added for clarification.
Agency Response: The Agency appreciates and acknowledges these comments. This section has been reworded for clarification.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has removed the terminology “hereditary disorders” so that the language refers to newborn screening, in general.
Governor’s Advisory Council for Exceptional Citizens, Terri A. Hancharick, Chairperson
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has changed the section to read, “The purpose of these regulations is s to describe the procedures for the Newborn Screening Program where each newborn delivered in the state must be provided a panel of screening tests to identify metabolic, hematologic, endocrinologic and certain structural disorders that may result in developmental delay, cognitive disabilities, serious medical conditions, or death.”
Second, in the same “sentence”, Council recommend deletion of the word “certain” between “identify” and “metabolic”. Compare comparable provisions in title to §4.0, §4.1, and 6.1. The definitions of “endocrinologic disorder”, “hematologic disorder”, and “metabolic disorder” are not restrictive. Indeed, the definition of “metabolic disorder” refers to “include, but are not limited to...”.
Agency Response: The Agency appreciates and acknowledges these comments. The word certain has been removed before “metabolic.”
Agency Response: The Agency appreciates and acknowledges these comments. We have made the terminology consistent and have replaced “institution” with “facility” throughout the regulations.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has changed “result” to “results.”
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has added “health” to read “primary health care provider.”
Sixth, §6.1.1 refers to “no later than 3 days after birth...” The strikeout of “3" results in a confusing reference.
Agency Response: The Agency appreciates and acknowledges these comments. The word “three” has been added for clarification.
Agency Response: The Agency appreciates and acknowledges these comments. This section has been reworded for clarification.
Eighth, in §7.1 and §7.2, - ‘hospital/institution of birth hospital – one of the ‘hospitals’ is redundant.
Agency Response: The Agency appreciates and acknowledges these comments. The redundant language has been removed.
Ninth, in §7.1.2, there is a typographical error on the second line, designated unsatisfactory by the laboratory. The quotation marks should be around “unsatisfactory”. The hyphen before ‘by’ may be the continuation of a strikethrough and should be clarified.
Agency Response: The Agency appreciates and acknowledges these comments. This section has been removed.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has removed the terminology “hereditary disorders” so that the language refers to newborn screening, in general.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations Governing Screening of Newborn Infants for Metabolic, Hematologic, Endocrinologic, and Certain Structural Disorders are adopted and shall become effective May 11, 2013, after publication of the final regulation in the Delaware Register of Regulations.
4107 Testing Screening Oof Newborn Infants Ffor Metabolic, Hematologic, And Endocrinologic, and Certain Structural Disorders
Under the authority granted to the Department of Health and Social Services, Division of Public Health under 16 Del.C. §122(1), 16 Del.C. §122(3)(h), and 29 Del.C. §7904 the Department of Health and Social Services, Division of Public Health, State of Delaware adopts the following regulations pertaining to the testing screening of newborns for various disorders.
These regulations describe [To regulate the procedures for The purpose of these regulations is to describe the procedures for] the Newborn Screening Program administered by the Delaware Division of Public Health. Under the authorization of the statues listed above, where each newborn delivered in the state must be provided a panel of screening tests to identify certain metabolic, hematologic, and endocrinologic, and certain structural disorders that may result in developmental delay, mental retardation, cognitive disabilities, serious medical conditions, or death.
These regulations clarify responsibilities among the parties involved.
These regulations apply to each newborn infant born in the State. The responsibility for implementation of the regulations rests with the institution in which the infant is born, or if an infant is born outside an institution, with the person required to prepare and file the certificate of birth and with the newborn’s primary care provider. If an infant is born outside [an institution or a] facility, the responsibility for implementation of the regulations rests with the attending [delivering] physician or midwife, the newborn’s primary [health] care provider and the parent or legal guardian.
“Blood Specimen for Metabolic, Hematologic and Endocrinologic Disorders” means a dried blood spot on a special filter paper utilized for screening (not diagnostic) tests to establish the likely presence of [certain] metabolic, hematologic or endocrinologic disorders.
Certain Structural Disorders includes critical [cardiac congenital] heart defects and other structural disorders.
“Designated Laboratory” is the laboratory or laboratories, which have been selected by the Division of Public Health to perform these services.
“Endocrinologic Disorder” means the absence or deficiency of a hormone resulting in interference with normal health, growth or development. These disorders include Congenital Hypothyroidism (CH) and Congenital Adrenal Hyperplasia (CAH).
“Hematologic Disorder” means, in these regulations, a condition in which a variation in one or more of the hemoglobin structural genes or in one or more of the genes involved in hemoglobin synthesis produces a variation in hemoglobin structure or synthesis, which result[s] in variation in hemoglobin function. The term “hemoglobinopathies” includes sickle cell anemia, sickle cell hemoglobin C disease (SC disease), sickle beta thalassemia, beta thalassemia, alpha thalassemia, hemoglobin C disease and other clinically important variations in hemoglobin structure or synthesis.
“IMF” stands for Insufficient Milk Feeding, which is an inadequate time frame for milk feedings (<24 hours) prior to obtaining the blood spot specimen.
“Kit” means any or all parts of the combined materials, laboratory filter paper specimen forms, lancets, envelopes, Newborn Screening Program brochure, and/or other components provided by the State Newborn Screening Program for the purposes of collection of the blood spot specimen and for submission of the blood spot specimen for laboratory testing screening.
“Metabolic Disorder” means a disorder caused by a genetic alteration, which results in a defect in the structure or function of a specific enzyme or other protein. These disorders include, but are not limited to, Phenylketonuria (PKU), Galactosemia, Maple Syrup Urine Disease (MSUD), and Medium Chain Acyl-CoA Dehydrogenase (MCAD) Deficiency.
Newborn Infant” means any infant born in the state who is under 4 weeks of age.\
[“Pulse Oximetry Screening” is non-evasive test allowing for determination of the oxygen saturation of a patient’s hemoglobin to screen for a critical congenital heart defect.]
“Satisfactory Specimen” means a blood spot specimen on which an accurate laboratory analysis for the various disorders can be performed.
“The Newborn Screening Advisory Committee” means a committee, established through the Division of Public Health Newborn Screening Program, convened to provide advice and guidance to the Newborn Screening Program. Members include, but are not limited to: individuals or parents of individuals with one of the disorders for which screening is performed; physicians not employed by the Division of Public Health who have expertise in the disorders for which screening is performed; an attorney not employed by the Division of Public Health; an ethicist not employed by the Division of Public Health; representatives of relevant agencies within the Department of Health and Social Services. The Committee will meets at least semi-annually. The Director of the Division of Public Health will appoint members after recommendation by the Newborn Screening Program.
“Unsatisfactory Specimen” means a blood spot specimen which is of insufficient quantity; or a blood spot specimen on which an accurate analysis for the various disorders cannot be performed.
4.0 Persons Responsible for Submitting Blood Spot Specimens and Pulse Oximetry Results for Screening for Metabolic, Hematologic, and Endocrinologic, and Certain Structural Disorders
4.1 The person or [institution facility] responsible for assuring that a satisfactory blood spot specimen and pulse oximetry results is are submitted for testing screening newborns for metabolic, hematologic, and endocrinologic and certain structural disorders shall be, in order of responsibility:
4.1.2 the newborn’s primary [health] care provider; or, if no provider is identified;
4.3 In cases of newborns not born in a hospital or other licensed health care facility, and not transferred to a health care facility, the timely collection of the blood spot specimen and pulse oximetry screening results shall be the responsibility of the following, in order of responsibility:
4.3.1 the attending [delivering] physician, or midwife, or in the absence of such a person;
4.3.2 the newborn’s primary [health] care provider; or, if no provider is identified;
4.3.3 the parent or legal guardian.
5.2 Blood spot specimens collected for testing screening shall be forwarded from the [institution collecting facility] at which the specimen is collected to the designated laboratory within 24 hours of collection, either by the designated Division of Public Health courier or by mail.
6.0 Timing of Collecting the Blood Spot Specimen and Pulse Oximetry Screening for Screening Infants
6.1.1 For infants born inside or outside of a hospital or other health care facility, or infants born outside of a hospital or other health care facility and transferred to the hospital where they will remain for the next 24 hours, a specimen shall be collected not sooner than 24 hours after the onset of milk feeding, but no later than 3 days after birth, preferably between 36 and 72 hours of birth. A second specimen is to be collected between 7 seven and 28 days of age.
5.1.2 For infants who are born in a hospital or health care facility or who are born outside and transferred into the hospital and who will remain in the hospital for 24 hours of milk feedings or more a blood spot specimen shall be collected not sooner than 24 hours after the onset of milk feeding, but no later than 3 days after birth, preferably between 36 and 72 hours after birth. A second blood spot specimen is to be collected between 7 and 28 days of age.
6.1.32 For pre term or sick newborns, the initial blood spot specimen [may be collected as late as 3 three days of age and must be collected but no later than 3 days regardless of birth weight, illness or nutritional status shall be collected between 24 hours and 48 hours after birth, if possible]. The second dried blood spot specimen on preterm or sick newborns is to be done must be completed at hospital discharge [or 28 days of life which ever comes first or transfer if within seven days from birth, or otherwise at 8 – 10 days. A third specimen on pre-term or sick newborns shall be collected between 21-24 days or at discharge, whichever comes first.]
6.1.43 When an infant is discharged from a hospital or other health care facility before 24 hours of milk feedings a blood spot specimen shall be obtained immediately prior to discharge from the facility and a second dried blood spot specimen shall be obtained after 3 days of age and before 14 days of age.
7.0 Procedures for Follow Up of Dried Blood Spot Specimens that were obtained prior to 24 Hours Of Milk Feeding (Imf) and for those whose Results are Designated as Abnormal or Suspicious
7.1 The hospital or institution of birth or the hospital to which a newborn is transferred The hospital/[institution facility] of birth[/hospital] to which a newborn is transferred shall develop adequate procedures to insure that a satisfactory blood spot specimen is collected by the time each newborn is 2 weeks old three days of age. The sample must be taken from each every newborn. [who is described by one or more of the following categories:
7.2 The hospital/[institution facility] of birth[/hospital] or institution of birth, the hospital to which a newborn is transferred and the primary [health] care provider of the newborn shall cooperate with the Newborn Screening Program in completing follow up of newborns whose blood spot specimen result is designated as “abnormal” or “suspicious.” This cooperation shall include:
7.2.1 pProviding appropriate demographic information to the Newborn Screening Program as requested on each baby whose blood spot specimen result is designated as “abnormal” or “suspicious,”
9.1 The Newborn Screening Program shall maintain and treat as confidential all newborn screening communications with [institutions facilities], families and health care providers. The Newborn Screening Program shall maintain and treat as confidential a record of every newborn in whom a diagnosis of one or more of the various metabolic, hematologic, or endocrinologic disorders is confirmed.
10.1 The Division of Public Health Newborn Screening Program shall bill the [institution facility] or individual for services provided to the institution or individual for each newborn screened under these regulations including but not limited to, the cost of the kits for collection of specimens, the laboratory fee for analysis, and administrative costs. The fee will be determined annually (in July) based on cost of the program.
10.2 No Delaware newborn shall be denied testing for hereditary disorders because of inability of the newborn's parentor legal guardian to pay the fee. A "Statement of Fee Exemption" form will be provided to the practitioner or parent requesting exemption from fees. This form must be completed and submitted to the Newborn Screening Program Office within 30 days of birth.
11.2 In the event a religious exemption is claimed from the requirements for [testing for Hereditary Disorders screening], the person otherwise responsible for submitting the specimen for testing screening shall be responsible for submitting a completed affidavit to the Delaware Newborn Screening Program Office, signed by the infant's parent or legal guardian, using the following language:
Under the Authority granted to the Department of Health and Social Services, Division of Public Health under 16 Del.C §107, "whoever refuses, fails or neglects to perform the duties required under this chapter, or violates, neglects or fails to comply with the duly adopted regulations or orders of the Division shall be fined not less than $100 and not more than $1,000, together with costs, unless otherwise provided by law."
Last Updated: December 31 1969 19:00:00.
site map   |   about this site   |    contact us   |    translate   |    delaware.gov