Description
For this assignment, you will review the NB Screening Provider Manual (see below link). Please copy and paste the below question into a Word document. Then use correct spelling, punctuation, and complete sentences. Please note that proper grammar is the expectation, highlight or bold your answers
How long should a specimen card dry before mailing?
What lancet size should be used on a newborn?
Why is warming the infant’s heel important?
What is the maximum temperature of a heel warmer?
Explain why the first drop of blood should be wiped away.
Explain why you should not press the paper against the puncture site.
When should the specimen be shipped?
When should the 2nd NB screening be collected?
Explain what would cause a specimen to be unsuitable.
List the types of disorders an NB Screening detects.
Does the parent have the right to refuse an NB Screening?
Explain how a heel warmer promotes blood flow.
Why is it important not to “piggyback” drops of blood onto the filter paper after a few seconds have passed?
Why is it important that complete saturation occur on the filter paper?
While the specimen is drying, why is it essential to keep it out of heat and light?
List ALL special considerations and why they can affect test results.
How long after the birth of an infant should the 1st NB screening be collected
Explain why a dermal puncture is not performed on the foot’s central area.
Explain how “milking” affects the test.
Unformatted Attachment Preview
Saving lives with
a simple blood spot
Health Care
Provider
Manual
Newborn Screening Program
The Complete Guide to Newborn
Screening in Washington State
Washington State Department of Health
DOH 951-117 October 2019
For persons with disabilities, this document is available on request in other formats.
To submit a request, please call 1-800-525-0127 (TDD/TTY 1-800-833-6388).
Newborn Screening Program
Health Care Provider Manual | i
CONTENTS
CONTENTS
Introduction ……………………………………………………………………………………………………………………………… 1
Health Care Providers and Institutions: Specimen Collection and Handling………………………………………. 3
Responsibility for Obtaining a Newborn Screening Specimen ………………………………………………….. 3
Parental Right to Refuse ……………………………………………………………………………………………………… 3
Timing of Screening…………………………………………………………………………………………………………….. 3
Completing the Specimen Collection Card …………………………………………………………………………….. 5
Specimen Collection……………………………………………………………………………………………………………. 7
Drying & Shipping Specimens ………………………………………………………………………………………………. 9
Screening Results ……………………………………………………………………………………………………………….. 9
Requesting Screening Results ………………………………………………………………………………………………. 9
Newborn Screening Program: Screening Tests, Reporting Results and Follow-up ……………………………. 10
Reporting Results ……………………………………………………………………………………………………………… 10
Normal Results …………………………………………………………………………………………………………………. 10
Abnormal Results ……………………………………………………………………………………………………………… 10
Requests for Repeat Screening …………………………………………………………………………………………… 11
Unsuitable Specimens ……………………………………………………………………………………………………….. 11
Report Format ………………………………………………………………………………………………………………….. 11
Program Requests for Information ……………………………………………………………………………………… 11
Special Considerations ……………………………………………………………………………………………………………… 12
Transfusions …………………………………………………………………………………………………………………….. 12
Premature Infants and Sick Infants……………………………………………………………………………………… 12
Transferred Infants …………………………………………………………………………………………………………… 12
Birth or Residence outside of Washington State …………………………………………………………………… 12
Children who are Adopted, in Foster Care OR in Protective Custody ………………………………………. 13
Infants with Clinical Signs of the Disorders Screened…………………………………………………………….. 13
Infants with Family History of the Disorders Screened ………………………………………………………….. 13
Screening Older Children …………………………………………………………………………………………………… 13
Screening for Disorders Not Detected in Washington’s Panel ………………………………………………… 14
Storage of Newborn Screening Card……………………………………………………………………………………. 14
Newborn Screening Fee …………………………………………………………………………………………………….. 14
Disorders Included in the Washington Newborn Screening Panel………………………………………………….. 15
Amino Acid Disorders……………………………………………………………………………………………………………….. 15
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ARGININOSUCCINIC ACIDEMIA (ASA) & CITRULLINEMIA (CIT) …………………………………………………………………. 16
HOMOCYSTINURIA (HCY) ……………………………………………………………………………………………………………. 18
MAPLE SYRUP URINE DISEASE (MSUD) ……………………………………………………………………………………………. 20
PHENYLKETONURIA (PKU) …………………………………………………………………………………………………………… 22
TYROSINEMIA TYPE I (TYR-I) ………………………………………………………………………………………………………… 24
Fatty Acid Oxidation Disorders ………………………………………………………………………………………………….. 26
CARNITINE UPTAKE DEFICIENCY (CUD) …………………………………………………………………………………………….. 27
LONG-CHAIN L-3-HYDROXYL ACYL-COA DEFICIENCY (LCHAD) & TRIFUNCTIONAL PROTEIN (TFP) DEFICIENCY …………. 29
MEDIUM-CHAIN ACYL-COA DEHYDROGENASE (MCAD) DEFICIENCY ………………………………………………………….. 31
VERY LONG-CHAIN ACYL-COA DEHYDROGENASE (VLCAD) DEFICIENCY ……………………………………………………….. 33
Organic Acid Disorders……………………………………………………………………………………………………………… 35
3-HYDROXY-3-METHYLGLUTARIC ACIDURIA (HMG) ……………………………………………………………………………… 36
BETA-KETOTHIOLASE (BKT) DEFICIENCY ……………………………………………………………………………………………. 38
GLUTARIC ACIDEMIA TYPE I (GA-I) …………………………………………………………………………………………………. 39
ISOVALERIC ACIDEMIA (IVA)…………………………………………………………………………………………………………. 41
METHYLMALONIC ACIDEMIAS (MMA) & PROPIONIC ACIDEMIA (PROP) …………………………………………………….. 43
MULTIPLE CARBOXYLASE DEFICIENCY (MCD) ……………………………………………………………………………………… 45
Endocrine Disorders …………………………………………………………………………………………………………………. 47
CONGENITAL ADRENAL HYPERPLASIA (CAH) ………………………………………………………………………………………. 48
CONGENITAL HYPOTHYROIDISM (CH) ………………………………………………………………………………………………. 50
Lysomosomal Storage Disorders………………………………………………………………………………………………… 52
GLYCOGEN STORAGE DISORDER TYPE II (POMPE DISEASE) ……………………………………………………………………. 53
MUCOPOLYSACCHARIDOSIS TYPE-I (MPS-I) ………………………………………………………………………………………. 55
Other Disorders……………………………………………………………………………………………………………………….. 56
BIOTINIDASE (BIOT) DEFICIENCY ……………………………………………………………………………………………………. 57
CYSTIC FIBROSIS (CF) …………………………………………………………………………………………………………………. 58
GALACTOSEMIA (GALT) ……………………………………………………………………………………………………………… 60
SICKLE CELL DISEASE & OTHER HEMOGLOBINOPATHIES (HB) ……………………………………………………………………. 62
SEVERE COMBINED IMMUNODEFICIENCY (SCID)………………………………………………………………………………….. 65
X-LINKED ADRENOLEUKODYSTROPHY (X-ALD) ……………………………………………………………………………………. 67
Clinical Features ……………………………………………………………………………………………………………….. 67
Etiology …………………………………………………………………………………………………………………………… 67
Screening Test ………………………………………………………………………………………………………………….. 68
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Diagnosis and Long-term Follow-up ……………………………………………………………………………………. 68
Treatment ……………………………………………………………………………………………………………………….. 68
Miscellaneous Information ………………………………………………………………………………………………… 68
EARLY HEARING LOSS…………………………………………………………………………………………………………………. 69
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INTRODUCTION
Newborn screening is a population-based, preventive public health program that is carried out in every state in
the United States and in many countries throughout the world. It enables early identification of selected
disorders that, without detection and treatment, can lead to permanent mental and physical damage or death in
affected children. The goal of newborn screening is to facilitate prevention of developmental impairments (such
as mental disability and neurological deficits), delayed physical growth, severe illness, and death through early
detection and intervention.
Across the United States, there are variations in the disorders for which each state screens. Click here to see the
list of disorders tested for in Washington State. Although testing is possible for many other disorders,
Washington adds tests to the newborn screening panel only after careful consideration of the following criteria
set by the State Board of Health:
Available Technology: Sensitive, specific and timely tests are available that can be adapted to mass
screening.
• Diagnostic Testing and Treatment Available: Accurate diagnostic tests, medical expertise and effective
treatment are available for evaluation and care of all infants identified with the condition.
• Prevention Potential and Medical Rationale: The newborn identification of the condition allows early
diagnosis and intervention.
• Public Health Rationale: Nature of the condition justifies population-based screening rather than riskbased screening or other approaches.
• Cost-Benefit / Cost–Effectiveness: The outcomes outweigh the costs of screening.
See the Washington State Board of Health Process to Evaluate Conditions for Inclusion in the Required Newborn
Screening Panel for more information.
•
Successful newborn screening requires collaboration between the State Newborn Screening Program, health
care facilities (hospitals, clinics, laboratories, and birth centers), health care providers (pediatricians, family
practice physicians, nurse practitioners, midwives), and families of newborns. The Washington State Newborn
Screening Program is within the Department of Health and is located at the State Public Health Laboratories
facility in Shoreline. It is a coordinated system of screening services comprised of laboratory, follow-up, and
support staff. In October 2019, the Washington State Newborn Screening Program established a contract with
the Hawaii Department of Health and began providing newborn screening services for babies born in Hawaii.
Responsibilities of the Washington State Newborn Screening Program are:
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Perform rapid, efficient screening of children born in the state for the disorders required by state
regulation (WAC 246-650)
Verify each newborn has had access to screening and if not, take action to assure screening is available
Provide appropriate follow-up and recommendations to health care providers for newborns with
abnormal screening test results to facilitate prompt diagnostic and treatment services
Consult with health care providers regarding test implications and recommend follow-up actions
Perform long-term follow-up and tracking of affected children to evaluate outcomes of the program,
improve effectiveness and promote continued access to appropriate specialty health care
Collect, analyze, and disseminate data on newborn screening requirements, including cost effectiveness
of the system and health outcomes
Provide technical assistance and education regarding all components of newborn screening to hospitals,
health care professionals, families of affected children, and the general public
Responsibilities of the health care facilities and providers are:
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Newborn Screening Program
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Provide proper collection, labeling, and handling of newborn screening specimens
Collect and send specimens to the State laboratory within the required timeframes (RCW 70.83.020)
Document the screening status of each infant
Quickly respond to information and specimen requests from the Newborn Screening Program
Ensure prompt follow-up on infants requiring further testing to rule out or confirm a diagnosis
Provide parent education about newborn screening and refer for diagnostic and clinical care services as
needed
When appropriate report to the Newborn Screening Program the date the parent/guardian was notified
of the need for further diagnostic testing
Responsibilities of the families are:
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Educate themselves about the newborn screening tests that will be performed on their infant
Report to their health care provider the presence of a family history of any screened or unscreened
disorder
Respond quickly to requests from the health care provider or Department of Health for repeat screening
Cooperate with health care providers and institutions when required for follow-up
Back to List of Content
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HEALTH CARE PROVIDERS AND INSTITUTIONS: SPECIMEN COLLECTION AND HANDLING
RESPONSIBILITY FOR OBTAINING A NEWBORN SCREENING SPECIMEN
Washington State law (RCW 70.83.020) requires newborn screening for all infants born in Washington State.
Each hospital or health care provider attending a birth outside of a hospital is required to collect a newborn
screening blood specimen (or signed parental refusal) within 48 hours of an infant’s birth. This specimen (or
signed parental refusal) must be received by the Newborn Screening Laboratory within 72 hours of collection.
Healthcare providers are to inform parents or guardians about newborn screening prior to collection of the
specimen, including the legal requirement for screening and the right to refuse based on valid reasons (see next
section).
PARENTAL RIGHT TO REFUSE
According to state law (RCW 70.83.020), a newborn screening specimen should not be obtained for any infant
whose parents or guardian object due to religious tenets and practices. In the instance that the
parents/guardians refuse screening for religious reasons, it is the responsibility of the birth hospital or out of
hospital birth attendant to document the refusal appropriately. To document, complete the demographic
information on the screening card and obtain the signature of the infant’s parent/guardian on the reverse side
of the card in the space provided. As with a blood specimen, the refusal signature must be obtained within 48
hours of birth, and the card must be received by the Newborn Screening Laboratory within 72 hours of
collection. A record of the refusal should be included in the infant’s medical records.
It is important to note that religious reasons are the only valid basis for refusal per State law. Newborn screening
statistics indicate that the majority of infants whose parents sign a refusal in the hospital are later tested,
suggesting that the refusal was not truly based on religious principles. This dangerous practice could result in a
delayed diagnosis for an affected infant and place them at significant risk of permanent damage or possibly
death. The provider should make certain that the parent/guardian understands the risks to their child for
refusing screening prior to signing the refusal. Copies of the text on the reverse side of the card regarding
parental right to refuse are available for reference on the website in several languages.
TIMING OF SCREENING
In addition to the required first newborn screening specimen for each infant, it is strongly recommended that
every newborn have a second screening specimen collected. This recommendation has been carefully
considered relative to the specific disorders included on the Washington State Newborn Screening Panel. The
first screen is essential for ensuring an early diagnosis to prevent life threatening events such as a salt-wasting
crisis in a child with CAH, a fatal bacterial infection in a baby with Galactosemia, or a fatal metabolic crisis in a
baby with inborn errors of metabolism. The second specimen optimizes detection of the disorders and is
especially important for detection of cystic fibrosis, homocystinuria, congenital hypothyroidism, and milder
forms of the other disorders. All specimens are tested for all disorders on the State Newborn Screening Panel.
The timeframes for collection of each specimen are as follows:
1st Newborn Screen: Collect for every newborn between 18 to 48 hours of age.
State law requires that a specimen be collected for each newborn prior to 48 hours of age. It is the
recommendation of the Department of Health that the first newborn screening specimen be collected
after 18 hours of age whenever possible, as specimens collected earlier than 18 hours yield higher rates
of false positive results. Under certain circumstances, a specimen may be collected prior to 18 hours of
age – please see Special Considerations for infants who are premature, sick, or will receive interfering
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substances. If an infant will not be with a medical provider during the recommended timeframe of 18-48
hours of age, it is also acceptable to collect a specimen earlier.
2nd Newborn Screen: Collect for every newborn between 7 and 14 days of age.
The standard of care in Washington State is to collect a second newborn screen within this time frame
regardless of the results on the first newborn screen. The 2nd specimen may be collected earlier than 7
days if it fulfills any of the following criteria:
•
Newborn screening program staff have specifically requested an early second specimen
• Uncertainty that the child will be seen by a medical provider during the 7-14 day period
When collecting an early 2nd screen, please allow for at least 72 hours between the collection of the 1st
and 2nd screens.
3rd Newborn Screen: A third specimen collected at one month of age is recommended for all sick (requiring
three or more weeks of hospitalization) and premature infants. Infants who have received interfering
substances prior to collection of the 1st or 2nd newborn screen, may require a 3rd specimen. Please
review the Special Considerations guidelines for the appropriate timeframe to collect a 3rd screen
depending on the infant’s circumstances.
If there are immediate clinic concerns for an infant, we recommend pursuing diagnostic testing in addition
to collecting a routine 2nd or 3rd newborn screen.
If the screening status of an infant is unknown, such as for infants moving to Washington from out of the
country, closed adoptions, or foster care cases, a specimen may be collected up to 6 months of age.
NOTE: It is no longer necessary for an infant to feed prior to specimen collection.
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Health Care Provider Manual | 5
Newborn Screening Program
COMPLETING THE SPECIMEN COLLECTION CARD
Washington State screening cards may be ordered online at www.doh.wa.gov/nbs. Click “Order Collection
Cards” on the left-hand menu and complete the order form. Screening cards are provided free of charge.
A copy of the current screening card with instructions on completing is shown below:
Demographic Information
Filter Paper
7
1
8
9
2
10
3
13
4
14
5
15
6
17
11
Barcode number
12
16
The information requested on the screening card is critical to interpreting the laboratory test results and
facilitating rapid communication with the baby’s medical provider. Complete all information on the card using a
ballpoint pen. Please fill in bubbles completely. Avoid touching the filter paper while completing the form as this
could contaminate the specimen. Instructions for completing each field on the card are as follows. See How to
Fill Out Newborn Screening Collection Cards for a quick guide:
1
Mother’s Information: Write the mother’s legal first and last name. Do not use middle names. Be mindful of
two-word names and which row is appropriate for which part of the name. The mother’s first and last name
is used to link the infant’s first and second newborn screening specimens in the Newborn Screening Program
computer system. This linking may not occur if this information is different on the two specimen cards.
Without this linkage, the Newborn Screening Program may contact the health care provider to collect an
unnecessary specimen because it appeared a specimen was not collected.
2
Maternal Steroids: Indicate if the mother received steroids in the last 7 days by filling in the “Maternal
Steroids” bubble. Write the date when steroids were last administered to the mother.
Maternal steroids can produce a false negative screening result for congenital adrenal hyperplasia (CAH).
Steroids, in any form (oral, nasal, topical), can be transferred to the unborn baby through the mother if
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Newborn Screening Program
Health Care Provider Manual | 6
received within seven days prior to delivery. Also, if the mother is nursing, steroids can be passed through
the breast milk to the baby if the mother received steroids after delivery.
3
Miscellaneous Information: Indicate anything relevant, such as: adoption, foster care, surrogacy, child
protective services, family history of a newborn screening disorder, or moving/transferring out of state. If
none of these apply, this area may be used for your internal purposes (such as who collected the specimen,
tracking numbers, etc.)
4. Birth Facility: Write the ID# for the hospital or birth center where the infant was born. The ID#s for birthing
facilities are listed on the inside of the manila-colored portion of the screening card. If a home birth, write
the individual midwife ID#. Individual midwife ID#s are available online, see Midwife ID#s. If the infant is
born in another state or country, please use the code “X-9999, Out of State” in this field and further identify
the location of birth in the Miscellaneous Information section. For a complete list of ID#s, please visit our
online ID# Directories. The birth facility field assists in identifying the child when transferred as well as
linking first and second specimens for all infants.
5. Submitter ID: Write the ID# of the facility that collected the infant’s specimen. If the collection facility is the
same as the birth facility, you may fill in the “same as birth facility” bubble instead. If collected at the
infant’s home, write the individual midwife ID#. The ID#s for birthing facilities are listed on the back of the
screening card. For a complete list of ID#s, please visit our online ID# Directories. The screening results will
be sent to the submitter listed on the specimen card.
6. Follow-Up Care: Write the ID# of the facility where the child will receive outpatient care. If the child will
remain in-house at the hospital, write the hospital’s ID#. If the child will be seen by a midwife, write the
individual midwife ID#. If the same facility/midwife that collected the specimen will remain the infant’s
outpatient care, fill in the “same as submitter” bubble. The facility or midwife listed on the card will be
contacted when abnormal results require follow-up. Following-up on abnormal results promptly requires
identifying the health care provider caring for the child. Every effort should be made to ensure the follow-up
care ID# is provided. For a complete list of ID#s, please visit our online ID# Directories.
7. Blank Space: This space is intentionally left blank to allow submitters an area to place bar code stickers or
other internal use information. Do not allow stickers to cover any demographic information on the card or
the shaded “Do Not Use This Area” box to the left. If you have a sticker that is too large to fit in this space,
place it on the reverse side of the card. Information provided on stickers must be for your internal use only –
any information provided by the sticker (such as baby name, sex, date of birth, mother’s name, etc.) will not
be data-entered into the Newborn Screening computer system, all requested information must be written in
the provided fields on the card.
8. Date & Time of Infant’s Birth: Write the date and time the child was born. Use of 24-hour based time or 12hour time (with appropriate AM/PM bubble indicated) is acceptable. The date/time of birth and date/time
of collection are used to calculate the exact age of the infant at the time the specimen was collected. The
infant’s age when the specimen was collected is crucial to correctly interpret the screening results. Small
age differences may determine whether a result will be classified as normal or abnormal.
9. Date & Time of Specimen Collection: Write the date and time when the specimen was collected. Use of 24hour based time or 12-hour time (with appropriate AM/PM bubble indicated) is acceptable. The date/time
of birth and date/time of collection are used to calculate the exact age of the infant at the time the
specimen was collected. The infant’s age at the time when the specimen was collected is crucial to correctly
interpret the screening results. Small age differences may determine whether a result will be classified as
normal or abnormal.
10. Child’s Name & Medical Record Number: Write the child’s legal name if known and their medical record
number. This allows for faster communication with healthcare providers.
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Newborn Screening Program
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11. Sex: Fill in the bubble corresponding with the biological sex of the infant. This information is used for
determining follow-up advice for certain conditions detected.
12. Gestational Age: Write the obstetrical estimate of the newborn’s gestation in completed weeks. Do no use
punctuation.
13. Birth Order: Indicate the infant’s birth order. Indicate “single” if there is only one birth or indicate the
appropriate bubble for a multiple birth in that pregnancy. This information ensures the correct child is being
identified.
14. Birth Weight: Write the weight of the child at birth. Do not write the weight of the child at the time of
specimen collection; always write the infant’s birth weight. This must be provided in grams. Do not provide
pounds/ounces and do not use any punctuation (decimals or commas). The infant’s birth weight is crucial to
correctly interpret the screening results. Weight differences may determine whether a result will be
classified as normal or abnormal.
15. Race/Ethnicity: Fill all the bubbles that apply for the infant. Include Aleut and Eskimo under Native
American and all of the following under Asian: Asian Indian, Cambodian, Filipino, Guamanian, Hawaiian,
Japanese, Korean, Laotian, Samoan, and Vietnamese. In addition to race, please indicate whether or not the
child is of Hispanic ethnicity.
16. Child’s Special Considerations: Indicate when the child is in the NICU or Special Care Nursery by filling in the
“NICU” bubble. If the infant has received interfering substances such as HA/TPN, Steroids, Antibiotics, or a
Red Blood Cell Transfusion prior to specimen collection, fill the appropriate bubble if the substance was
received within the timeframe below:
NICU: When an infant is or will be in the NICU or Special Care Nursery
HA/TPN: If the child received HA/TPN within 24 hours prior to specimen collection
Steroids: If the child received steroids within 7 days prior to specimen collection
Antibiotics: If the child received antibiotics within 24 hours prior to specimen collection
RBC Blood Transfusions: If received within 4 weeks. Indicate the date of last transfusion
Dopamine: Write this substance in the “Miscellaneous Information” section
These substances can interfere with screening tests by causing falsely elevated or lowered results. It is
important to indicate when these substances have been received so the Laboratory can appropriately
interpret the screening test results. See Special Considerations for more information.
17. Refusals: If a parent or guardian refuses the newborn screening test for religious reasons, fill the Refused
bubble at the bottom of the card and have the parent or guardian sign the back of the card in the space
provided. Still complete all demographic information on the card. See Parental Right to Refuse for more
information.
SPECIMEN COLLECTION
The blood collection instructions described below are based on the approved standard published by the Clinical
and Laboratory Standards Institute (CLSI). A video produced by this organization is available for loan. Posters on
specimen collection and unsatisfactory specimen quality examples are also available. If you would like to borrow
the video or order posters, please contact us. These are provided at no cost.
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Specimen Collection Instructions
Unsatisfactory Specimen Quality Examples
The following equipment will be needed for specimen collection: a sterile disposable lancet with a depth less
than 2.0 mm, a sterile 70% isopropyl alcohol pad, sterile gauze, a moist towel or heel-warmer, the blood
collection form, and gloves.
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Newborn Screening Program
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Gloves should be worn for personal safety. To prevent specimen contamination, do not touch the filter paper
section of the specimen card with gloved or ungloved hands, or contaminate with alcohol, formula, water,
powder, antiseptic solution, lotion, or other substances.
After confirming the identity of the infant and ensuring the expiration date of the card has not passed, place the
infant’s feet lower than the level of their heart in order to increase blood flow to the foot. To increase the blood
flow at the puncture site, warm the heel for three to five minutes using a heel-warmer or a moist towel at a
temperature no greater than 42°C (tempe
