Newborn Screening - Frequently Asked Questions


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Newborn Screening - Frequently Asked Questions

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General Information on Newborn Screening
Question: What is the newborn screening program?
Answer:

The Texas Department of State Health Services (DSHS) Newborn Screening Program consists of laboratory testing for 53 disorders, point of care screening for 2 more disorders, and clinical care coordination for infants with out-of-range test results. This testing is required by Texas law unless the parent refuses for religious reasons. To complete the tests, the baby’s healthcare provider will collect blood samples onto a blood spot card. The first sample is collected between 24 and 48 hours after the child is born. The second sample is collected at 7 to 14 days of age. If an out-of-range test result is detected for either specimen, DSHS Clinical Care Coordination will contact the baby’s primary care physician to ensure that the baby receives confirmatory testing and treatment, if needed. Early treatment of these disorders can prevent serious complications such as growth problems, developmental delays, deafness, blindness, intellectual disability, seizures, or even early death.
  
 Question: Does the current Newborn Screening panel in Texas include all disorders listed on the Recommended Uniform Screening Panel (RUSP)?
 Answer:

Texas does not test for all of the disorders listed on the Recommended Uniform Screening Panel (RUSP).  Texas’ current Newborn Screening panel does not include Glycogen Storage Disease Type II (Pompe), Mucopolysaccharidosis Type 1 (MPS I), X-linked Adrenoleukodystrophy (X-ALD), Galactoepimerase deficiency (GALE) and Galactokinase deficiency (GALK), and Spinal Muscular Atrophy due to homozygous deletion of exon 7 in SMN1 (SMA).   

   
Question: Why is newborn screening important?
Answer: Most children born with these problems appear healthy at birth and are from healthy families. Parents who already have healthy children, or who are "silent carriers" of a genetic condition, do not expect any problems. Because every baby is tested soon after birth, children who may have one or more of these disorders can be identified early and get early care. This can make a tremendous difference in health outcomes for the child
   
Question: What conditions does the newborn screening program cover?
Answer:

Texas law (Health and Safety Code, Chapter 33) requires that all newborns are screened for certain genetic disorders or medical conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) on the Recommended Uniform Screening Panel (RUSP). Currently for Texas, this includes screening

for 31 identified core  conditions, and reporting on 24 secondary conditions*. A list of the conditions on the Texas Newborn Screening Panel can be found here (pdf).

*Note Secondary conditions may be detected during screening for core conditions and some secondary conditions may be as severe and life threatening as core conditions.
  
 Question: Does the Newborn screen identify all babies with the disorders on the Texas panel?
 Answer: 

The newborn screen may NOT identify all babies with the disorders on the panel.  The newborn screening test identifies babies at risk of having a disorder on the panel.  However, if there are clinical symptoms or family history of a condition, the newborn screen results alone should not be used to rule out or confirm a condition; diagnostic testing should be pursued.

The newborn screening results should be considered by a medical professional in conjunction with family history and diagnostic testing, when warranted. 

   
 Question: 

What is a false positive result? 

 Answer: 

A false positive test result occurs when a test indicates that a person has a particular disorder when they actually are not affected by the condition.

  
 Question: 

What is a false negative result?

 Answer: 

A false negative test result occurs when a test indicates that a person does not have the particular condition when in fact they do have it. 

  
 Question: How are newborn screening test cutoffs determined, and why are they different among different states?
 Answer: Each state develops their own screening test cutoffs, which are appropriate for their state’s population.  Screening test cutoffs are calculated to allow for identification of babies with the disorder while minimizing both false positive and false negative results. In Texas, screening test cutoffs are determined by performing a study to identify the level of the analyte(s) that is indicative of the disorder. The study takes into account published data, the test method, and the type of equipment that will be used. Cutoffs for certain disorders also require considering infant specific factors such as age of the baby at specimen collection, birthweight, prematurity and transfusion status.  A sufficient number of specimens representing the Texas newborn population and true positive specimens, if available, are tested to determine the range where we would expect results from babies without the disorder to fall.  If a baby has results outside this range, then those results would be considered abnormal and would require additional testing.  Test cutoffs are routinely re-evaluated by comparison to diagnosed case test values and false negative specimen results.  In addition, the cutoff may also be revised to reduce the number of false positive results.
  
Question: Is more testing available?
Answer:

DSHS screens for many but not all diseases your baby may have. More tests can be done. For more information, ask your baby’s doctor and see www.babysfirsttest.org/find-condition or www.savebabies.org/pregnant_faqs.html.

Note: DSHS has no affiliation with these sites and the opinions and positions of these organizations may not reflect the opinions and/or positions of DSHS.  
   
Question: Why are two screens completed in Texas?
Answer: It is standard practice to collect the first sample early (24 to 48 hours of life), typically during the hospital stay, to detect some of the disorders at the earliest possible opportunity. However, in some cases, a disorder may only be detected on the second screen collected at 1 to 2 weeks. For example, studies indicate that 11 to 12 percent of hypothyroidism cases are detected only on a second screen. DSHS has implemented a two screen system to maximize the effectiveness of the testing for all of the 53 disorders.
   
Question: Who does the screening?
Answer: The healthcare provider collects the blood sample. The DSHS public health laboratory in Austin performs the laboratory testing.
   
Question: What happens if the test result is NOT okay?
Answer: An abnormal or “out of range” test result indicates that the baby may be at higher risk of having one or more of the disorders included on the newborn screening panel. This does not mean that the baby definitely has a disorder. In fact, most babies who receive "out of range" results do not have the condition of concern. If the newborn screen indicates “out of range” results, parents are contacted by their child’s healthcare provider. It is important that parents follow their healthcare provider’s directions for their child’s immediate care and additional testing.
   
Question: Can infants with any of these disorders be cured?
Answer: Most of these conditions can be treated but not cured. In these cases, early and continuous treatment can result in dramatic positive outcomes for the child and help prevent or control the serious effects of these disorders. Severe Combined Immunodeficiency (SCID), which was added to the newborn screening panel in 2012, is the one disorder on the panel that if identified early in life can be treated and for which most patients can be cured.
   
Question: Who pays for the screening?
Answer: Healthcare providers or facilities purchase the specimen collection kits *(which includes the cost of the testing) for private pay or insurance covered patients. DSHS provides specimen collection kits at no cost for patients covered by Medicaid, CHIP, and Title V. DSHS is reimbursed by Medicaid, CHIP, and Title V for the testing performed on these kits.
   
Question: Can parents opt out of having their newborn screened?
Answer:

Parents can only refuse to have their child screened if the screening conflicts with a parent’s religious tenets or practices (see Texas Health & Safety Code Sec. 33.012). In order to refuse, a parent must sign a form stating he/she has a religious objection to newborn screening. Points to consider before refusing newborn screening:

  • There are important medical benefits of newborn screening.
  • Symptoms of a newborn screening disorder can appear much later, after a child’s health has already been injured by the disease.
  • The screen is mandated by law.
  • The only legal reason to refuse newborn screening is if it conflicts with your religious tenets or practices.

If parents have concerns, they should talk to their baby’s physician or contact the NBS Program Staff by phone at (888) 963-7111, ext. 7333 or email mailto:newbornscreeninglab@dshs.texas.gov

Newborn screening of the blood spot consists of a series of tests to look for 53 diseases that can cause a baby to get really sick or die if they are not identified and treated early. The diseases can cause growth problems, mental or physical delays, deafness, blindness, seizures, and early death. Most babies with these conditions look perfectly normal when they are born, and problems may not appear for several weeks or months. About 1 child out of every 500 screened has one of these newborn screening conditions.
   
Question: How do I obtain my/my child's newborn screening results?
Answer:

Because an interpretation of the result report may be necessary, it is recommended that newborn screening results be released to physicians or medical professionals only. 

Individuals (if over 18) or parents (if under 18) may:

1.    Talk to your healthcare provider. Healthcare providers can request newborn screening results for their patients by contacting DSHS Laboratory Reporting, Monday through Friday 8am to 5 pm, by either: Sending a fax request to 512-776-7533 or calling 512-776-7578. OR

2.    Visit http://www.dshs.texas/lab/patientresults.aspx for information on how to obtain copies of your/your child’s test results. 
   
Question:  I am an NCAA college athlete and need to request my newborn screening results for documentation of my sickle cell trait status. How do I request these results? 
Answer: 

Because an interpretation of the result report may be necessary, it is recommended that newborn screening results be released to physicians or medical professionals only.

Individuals (if over 18) or parents (if under 18) may:

1.    Talk to your healthcare provider. Healthcare providers can request newborn screening results for their patients by contacting DSHS Laboratory Reporting, Monday through Friday 8am to 5 pm, by either: Sending a fax request to 512-776-7533 or calling 512-776-7578.

2.    Fill out the authorization form linked below to request the newborn screening results be sent to a specific physician. If requesting that the results be sent for university records, the school’s physician or nurse information should be included. Fax the completed form to DSHS Laboratory reporting at 512-776-7533.

Authorization to Disclose Protected Health Information (or other confidential information) Form (PDF 34kb)

The Texas DSHS Laboratory Reporting Department can provide newborn screening results from 1991 to present.
 
Use and Storage of Dried Blood Spots after Newborn Screening
Question: What happens to the blood spot card after testing?
Answer:

DSHS keeps the blood spot cards in a secure place. By Texas law (Health & Safety Code Sec. 33.018), the blood spots may be used until DSHS is required to destroy them. Uses include:

  • DSHS and external quality assurance to make sure tests, equipment, and supplies are working right
  • Developing new tests; and/or
  • DSHS studies of diseases that affect public health.

Additionally, if the parent gives their OK, blood spots collected on or after June 1, 2012 may be used for public health research outside of DSHS. Blood spots used outside DSHS will not include any information that can identify the child or parent, unless the parent provides a separate, specific consent.

DSHS storage of residual blood spots is governed by Texas law as detailed in the chart below:

  Received by DSHS prior to May 27, 2009 Specimen Collection Date
May 27, 2009 through 
May 31, 2012 		June 1, 2012 or Later
Blood Spot Storage after Completion of the Newborn Screening Tests   Blood spots received by DSHS prior to May 27, 2009, for which written consent to retain was not given, have all been destroyed. To be determined. All blood spots are stored for up to 2 years and then destroyed unless the parent submits a completed Parental Decision form allowing for longer storage.

Learn more about potential public health uses for blood spot cards after testing is completed.
   
Question: Where can parents or healthcare providers get copies of forms related to the storage and use of dried blood spots?
Answer: http://wwwstage.dshs.internal/lab/nbsBloodspots.shtm
   
Question: After collection of the first screen, the parent sent in a form related to the storage and use of dried blood spots. Do they need to send in another form?
Answer:

In most cases, additional forms are not needed. One form will apply to all blood spots collected from a baby.

In the event that the first blood spot specimen is collected prior to June 1, 2012 and the second specimen collected after June 1, 2012, it may be necessary to submit separate forms to indicate the parent’s wishes.
   
Question: What if the parent changes their mind? Can they submit a new form?
Answer: Parents can change their mind at any time as long as the blood spot cards have not been destroyed. DSHS will act upon the latest valid and applicable use and storage form received. Parents may contact the Laboratory for assistance if needed.
   
Question: Our facility only performs second screens, usually when the baby is around 2 weeks old. Are we required to give a form to the parents?
Answer: Yes. Forms regarding the use and storage of dried blood spots must be provided to parents / guardians for each newborn screening specimen drawn.
   
Question: Do forms related to the use and storage of dried blood spots allow the parent / guardian to choose NOT to have their child receive the newborn screen test?
Answer: No. Newborn screening is required for all newborns born in Texas. The only reason a parent / guardian may refuse to have the newborn screen test performed is because it conflicts with their religious beliefs stemming from an established religion. Use and storage of dried blood spots forms have nothing to do with accepting or declining the newborn screening tests.
   
Question: What happens if the parent does not return a form to DSHS in any manner?
Answer: For blood spots collected on or after June 1, 2012, parents are encouraged to return a decision form regardless of their choice. If no form is returned, the blood spots will not be used for external research purposes and will be destroyed within two years.
   
Question: If the parent completes and signs a form at the time of specimen collection, may the form be returned to DSHS with a specimen shipment from the provider?
Answer: Yes. Healthcare providers are required to return to DSHS completed forms related to the use and storage of dried blood spots if so requested by the parent.
   
Question: Some parents may be unsure at the time the blood spots are collected what they want DSHS to do with the dried blood spots after testing is complete. Do they have to decide before leaving the hospital / facility?
Answer: No. The parent / guardian can complete, sign, and mail the completed form to the DSHS address listed on the form at any time. For blood spots collected on or after June 1, 2012, the blood spots will be destroyed within 2 years after receipt of the specimen if no form is received.
   
Question: How should healthcare providers document that forms related to the storage and use of dried blood spots have been provided to a parent?
Answer: Healthcare providers should check the box on the NBS specimen collection kit demographic form indicating that the use and storage form was distributed.
   
Question: What happens if a parent completes and submits a “Directive to Destroy Newborn Screening Blood Spot Cards” form after June 1, 2012?
Answer:

If a “Directive to Destroy” form was received by the laboratory before June 1, 2012, all blood spots cards for the child would be destroyed within 60 days as required under House Bill 1672.

If a “Directive to Destroy” form is received by the laboratory after June 1, 2012, Destruction requests will only be processed for specimens that were collected prior to June 1, 2012. Blood spots cards collected on or after June 1, 2012 are stored for up to 2 years and then destroyed unless the parent submits a completed “Parental Decision for Storage and Use of Newborn Screening Blood Spot Cards” form that indicates their consent for storage of up to 25 years.
   
Question: Can a parent submit a “destruction” (Directive to Destroy Newborn Screening Blood Spot Cards) form after June 1, 2012 if one or all newborn screens were collected prior to June 1, 2012?
Answer: Yes. Destruction requests will be processed for all specimens collected prior to June 1, 2012.
Specimen Collection and Supply Ordering (for Healthcare Providers)
Question: How do I order newborn screening collection kits?
Answer:

Download an Order Form for Newborn Screening Supplies.
Or contact the Container Preparation Group at 1-888-963-7111 ext. 7661 (512-776-7661) or at mailto:ContainerPrepGroup@dshs.state.tx.ustexas.gov to obtain a copy of the order form.

Complete the order form by specifying the total number of kits needed by your facility. There are two kinds of Newborn Screening Kits: 

1.    NBS 3 – Medicaid/Charity Care/CHIP

2.    NBS 4 – Insurance/Self-Pay

Return envelopes and submitter labels are also provided at no charge. Indicate the quantity needed on the order form. Order a quantity of kits to last 1-3 months.

Fax the completed form to 512-776-7672. Orders will be processed and shipped within 5 working days from the day your order is received by the Container Preparation Group. (Note: Normal shipping [in transit] time is 1-3 days business days.)

Additional Information: 
NBS 3 (Newborn screening kits for Medicaid-eligible, Charity Care, or CHIP) kits are provided at no charge. For NBS 4 (Insurance or Self Pay) kits, an invoice will be sent later. Payment will be due within 90 days.
   
Question: How can we update our facility’s contact information (i.e., new address, phone or fax number or doctor)?
Answer: To update your facility’s contact information, complete the Submitter Identification Number Request/Update Form. 

This form is used for new submitters, as well as established submitters who need to update their information. When completing the form for an update, please make sure the “Updating Submitter Information” box is checked at the top. 

Fax the completed form to Laboratory Reporting at (512) 776-7533. 
   
Question: If our facility runs out of newborn screening kits before our next order arrives, is it ok to borrow newborn screening kits from another facility?
Answer:

SHARING CARDS IS STRONGLY DISCOURAGED. Every effort should be made to monitor inventory and plan accordingly for ordering. ONLY share or borrow cards if absolutely necessary.

Please be aware of the potential complications with sharing/borrowing cards:

1.    The result reports for the newborn screens will go to the original facility that purchased the kits UNLESS:

2.    The borrowing facility information (including submitter ID #) is placed in the submitter information portion of the demographic form of the newborn screening kit.

3.    DSHS is not responsible for billing issues that arise when borrowing/sharing cards. Any reimbursement arrangements for shared/borrowed cards need to be made between the facilities involved.

Please see above for information on ordering Newborn Screening supplies.
   
Question: When does the screening have to be performed?
Answer: The Texas Newborn Screening Program requests the collection of blood spots on two separate occasions for each child. The first screen is collected after 24 hours but before 48 hours of age, or prior to the newborn's discharge from the hospital. The second screen is collected at one to two weeks of age.
   
Question: Is it okay to collect specimens at 23 hours, instead of 24-48 hours, or at 6 days, instead of 7-14 days of age? What are the possible consequences if collected a little early?
Answer:

Reference (normal) ranges are set for a specific population. The DSHS reference ranges are set for specimens collected at 24-48 hours of age and a different set for specimens collected at 7-14 days of age. In the laboratory specimens are categorized by the age of the baby when the specimen was collected.

Collection of the first screen at 23 hours may not have a large impact. To accurately detect amino acid disorders, the infant really needs time to metabolize their first protein feedings. There may not be much difference in laboratory results between 23 and 24 hours. However, if a specimen were collected at 6 or 12 or 18 hours that will probably have some impact on the metabolites that are measured and their potential to be elevated.

Collection of a second screen at 6 days could have a large impact because it can lead to false negative results for fatty acid oxidation disorders. Fatty acid markers quickly start to normalize after the first few days of life. Fatty acid oxidation abnormal ranges are higher for first screen specimens than for second screen specimens. A specimen collected at 6 days will be analyzed using first screen reference values.
   
Question: What is the maximum age at which a child can be screened?
Answer: The Texas NBS Laboratory does not reject specimens collected on older children. The recommended collection time periods and the NBS testing methodologies have been designed to minimize the number of false negative and false positive results in newborns and young infants. When the newborn screen specimen is collected before 24 hours of age or on older children, the test may not identify some of these conditions. If there is a clinical concern, diagnostic testing should be initiated.
   
Question: If a baby has two newborn screens and one was “unsatisfactory,” is it necessary to collect a third newborn screen?
Answer:

See table below to determine necessity of a third screen:

1st screen 2nd screen 3rd screen necessary?
unsatisfactory normal No, if full term baby with a birth weight ≥2,500g
Yes, if low birth weight or premature baby with a birth weight of <2,500g
normal unsatisfactory Yes, up to 12 months of age
unsatisfactory abnormal Please follow recommendations received from DSHS Newborn Screening Clinical Care Coordination Team.
abnormal unsatisfactory Please follow recommendations received from DSHS Newborn Screening Clinical Care Coordination Team.

Newborn Screening Clinical Care Coordination
   
Question: What do we do if a baby has an unsatisfactory screen, but we are unable to get the baby back in for another one after multiple attempts to contact/notify the parent/guardian?
Answer: The healthcare facility should document all attempts made to the parent/guardian and keep the documentation in the baby’s medical record.
   
Question: How do I collect a newborn screen on a baby with casts on both feet?
Answer:

If the baby’s 1st screen was normal, obtain the 2nd screen when the casts are changed or removed.

If the baby’s 1st screen was abnormal, follow Newborn Screening Clinical Care Coordination guidelines.

If the baby’s 1st screen was unsatisfactory, refer to Alternative Methods for Collecting a Newborn Screen.
   
Question: Is it ever acceptable to collect a newborn screen from an area other than the heel?
Answer: The heel-stick is the preferred method for optimal laboratory results for the newborn screen. However, it is understood that certain circumstances may warrant alternative collection methods. For more information, please see the Specimen Collection – Special Circumstances web page, or the Alternative Methods for Collecting a Newborn Screen page.
   
Question: Where can I find more information on newborn screening specimen collection?
Answer:

Visit the DSHS Specimen Collection Requirements page or the Healthcare Provider Resources page.

Quick tip: Save these webpages as favorites for easy access whenever needed.
   
Question: Can parents opt out of having their newborn screened?
Answer:

A parent can refuse the screen for religious reasons only (Texas Health & Safety Code Sec. 33.012).  Make sure you and your staff are familiar with the benefits of screening and the consequences of undetected disorders. 
Points to consider before refusing newborn screening:

  • There are important medical benefits of newborn screening.
  • Symptoms of a newborn screening disorder can appear much later, after a child’s health has already been injured by the disease.
  • The screen is mandated by law.
  • The only legal reason to refuse newborn screening is if it conflicts with your religious tenets or practices.

Provide this information to parents who are considering refusing the screen. Download the Religious Objection to Newborn Screening Test form below and provide to parents who are sure they want to refuse newborn screening for their infant. The refusal of newborn screening must be signed by the parent/legal guardian/managing conservator and entered in the infant’s medical record.

English Form:  

FORM TO REFUSE THE NEWBORN SCREENING BLOOD TEST

Spanish Form: 

FORMULARIO DE RECHAZO DE LA PRUEBA DE DETECCIÓN TEMPRANA EN SANGRE A RECIÉN NACIDOS (NBS)

INSTRUCTIONS TO COMPLETE FORM TO REFUSE THE NEWBORN SCREENING BLOOD TEST 
   
Question: Does one specimen collection kit cover the first and second screening?
Answer: No. One kit is required for each screen. Each child will require two screening test kits.
   
Question: Specimens are required to be sent to DSHS as soon as possible, within 24 hours after collection. However, specimens collected late on Fridays do not dry in time to ship that day. Should we ship the specimen wet, or have the baby return the next week to draw an acceptable specimen?
Answer:

It is understood that it may not be possible to send all specimens as soon as possible after collection, especially for those specimens drawn before weekends or mail holidays. Specimens should be dried thoroughly and sent to DSHS as soon as possible, preferably by overnight courier.

Rules emphasize the importance of the timely collection and mailing of specimens so that children with these disorders can be identified, diagnosed and treated quickly. However, the first priority is to provide an acceptable specimen. Do not ask the parent/child to return later as this will delay the screening. Do not ship specimens wet.
   
Question: What is the recommended time frame for sending specimens to the DSHS laboratory?
Answer: New national recommendations state that first screen specimens should arrive at the DSHS Laboratory within 24 hours after collection. Ideally, specimens should arrive the day after collection. 
   
Question: How can my facility decrease our specimen transit time?
Answer:
  • DO NOT delay shipment of newborn screening specimens. Ship dried specimens as soon as possible, preferably via overnight courier. If mail or courier services are unavailable, ship as quickly as possible.
  • DO NOT batch or hold dried specimens for shipping.
  • Ship dried specimens directly from the collection facility to the DSHS Newborn Screening Laboratory.
Identify internal processes which may delay shipment and look for possible improvements. 

See Decreasing Time Between Collection of Newborn Screening Specimens to Receipt in DSHS Laboratory (PDF 861kb)
   
Question: How do I fill out the “mother information” section on the Newborn Screening kit if collecting on a child that is adopted, fostered or is a ward of the court or state?
Answer: The information in the “mother information” section of the Newborn Screening kit should reflect who the child will be in the care of upon release from the healthcare facility. This information is required for multiple laboratory and follow-up purposes. Most importantly, it is necessary for the Newborn Screening Clinical Care Coordinators to have accurate contact information of the child’s caregiver in the event that there is an abnormal newborn screen.
   
Question: How is “charity care” defined? We are trying to determine which type of test kit to use for a particular child.
Answer: The “charity care” newborn is a patient who is not insured, has a parent or guardian who is unable to provide payment, AND is not covered or eligible to be covered for newborn screening services by Medicaid, CHIP, or any other government program.
   
Question: We collected the specimen on an Insurance / Self-pay card and it should have been Medicaid. What do we do?
Answer: Please submit the specimen on the kit collected. DO NOT ALTER THE KIT IN ANY WAY. DSHS performs data analyses to identify Medicaid eligible specimens collected on Paid / Insurance cards. If a Medicaid eligible patient has a specimen collected on a Paid / Insurance card, the facility’s account will be credited for the cost of the kit.  The data analysis and reimbursement process takes 6 - 9 months.
 
Question: We collected the specimen on a Medicaid card and it should have been Insurance / Self-Pay. What do we do?
Answer: Please submit the specimen. Note on the collection kit that the specimen should have been collected on an Insurance / Self-Pay card. DSHS will bill the facility for the cost of the kit.
   
Question: If the parent states that they have Medicaid or are in the process of getting Medicaid but do not have the number available, which specimen collection card should be used?
Answer: Use the Insurance/Self-Pay card. If the child is later identified as Medicaid, the provider will be reimbursed in 6-9 months for the cost of the card.
   
Question: If the patient has both insurance and Medicaid, which specimen collection card should be used?
Answer: In this scenario, the provider should use the Medicaid card.
Question: May STAR plans use the Medicaid screening kits?
Answer: Yes. STAR plans are Medicaid- managed care plans. Patients seen under these plans are eligible for Medicaid. You will not be charged for kits for Medicaid-eligible, CHIP, and charity care newborns.
  
NBS4 (Insurance/Self-Pay) Kit Exchange of Expired Kits
Question:When will DSHS begin to accept requests to exchange expired NBS4 (Insurance/Self-Pay) kits for non-expired NBS4 kits? 
Answer:

DSHS will begin to accept exchanges on the date following kit expiration.  (For kits that expired on September 19, 2017; exchange requests will be accepted starting on September 20, 2017. Kits that have expired prior to the most recently expiring kits will not be accepted for exchange. 

  
Question:Do expired NBS3 (Medicaid/Chip/Charity) kits need to be returned to DSHS? 
Answer:

No, NBS3 kits do not need to be returned to DSHS for exchange. Expired NBS3 kits can be discarded. 

  
Question:How do I dispose of expired NBS Specimen collection kits?
Answer:Expired and unused NBS specimen collection kits can be discarded in the regular garbage, recycled with paper recycle, or shredded.
  
Question:What form do I need to fill out to request an exchange? 
Answer:Complete the G-6D “Newborn Screening Supplies”  order form. Count the number of expired NBS4 kits. Write the number of forms to be exchanged in the “Quantity Requested” box and write “Exchange” in the “Billing – Purchase Order Number” box section of the form. 
  
Question:Where and how do I send my exchange request and expired kits?
Answer:

The completed G-6D form and expired kits should be mailed to: 

For Overnight/Priority Shipping (UPS, DHL, FedEx, etc): 

Texas Department of State Health Services

Container Preparation Group

Laboratory Services Section, MC 1947

1100 W. 49th Street

Austin, TX 78756-3199 

For regular mail: 

Texas Department of State Health Services

Container Preparation Group

Laboratory Services Section, MC 1947

PO Box 149341

Austin, TX 78714-9341 

The cost for shipping is the responsibility of the submitter. 

  
Question: How long will it take to process an exchange request? 
Answer:Allow DSHS 5 business days from receipt of exchange request to process the request.
  
Question:

I ordered additional new kits when I requested an exchange, why have I not received my additional new order? 

Answer:

Although the same form is used to both request an exchange of expired forms and to order new kits, a separate form must be filled out for each type of request. If additional new kits are ordered on the same G-6D form as the request for exchange of expired kits, only the exchange request will be processed.

Example: 20 expired kits are sent in for exchange and 100 additional kits are requested on the same G-6D form. DSHS will only send out 20 new kits to cover the number returned for exchange. 

  
Question:
Can I request an exchange for kits now that are due to expire soon? 
Answer:
No, DSHS will only accept requests to exchange kits that have already expired. 
  
Question:How long do I have to request an exchange of expired NBS4 kits? 
Answer:

You have up to 3 months after the expiration date to submit a request to have expired NBS4 kits exchanged for non-expired kits.

  
Question:Will our facility be refunded the amount of the exchanged kits? 
Answer:

No. When an exchange request is received, DSHS will automatically send new kits for the exact number of kits that were returned. 

  
Question:
I would like to return expired kits but do not want new kits, will a refund be issued? 
Answer:
No. Expired NBS4 kits cannot be returned for a refund or credit. DSHS will automatically process the request as an exchange. 
  
Accessing Newborn Screening Result Reports Online (for Healthcare Providers)
Question: How do healthcare providers get access to the Texas Newborn Screening Web Application?
Answer:

1. Fill out:

2. Submit the completed forms:

For help, call: 888-963-7111, ext. 2484 or ext. 6275.

A Newborn Screening Submitter ID is required to complete this paperwork. If the facility does not have a Submitter ID, see the next question and answer below.
   
Question: I would like to access newborn screening results for my patients online, but my facility does not collect newborn screens. Do I have to collect newborn screening specimens in order to access the results online?
Answer:

Metabolic specialists, endocrinologists, pediatricians and other healthcare providers often need quick access to newborn screening results for their patients. It is not requirement that a facility submit newborn screening specimens in order to access newborn screening results online. However, healthcare providers/facilities are required to have a Submitter ID to access newborn screening results online.

Healthcare Providers/Facilities can obtain a Submitter ID or use the Submitter ID for a facility with which they are associated.

If you are a healthcare provider that would like to obtain a Submitter ID:

  • Complete the Submitter Identification Number Request/Update Form
  • If your facility will not be submitting newborn screening specimens, in the box “Type of tests to be submitted,” fill in with “None. Need online access to NBS results.”
  • Fax to Laboratory Reporting at (512) 776-7533.

Once you have obtained a Submitter ID, signup for online access by following the steps outlined in the question & answer above, How do healthcare providers get access to the Texas Newborn Screening Web Application.

If you are a healthcare provider that would like to use a Submitter ID for a facility with which you are associated, call the telephone number below for help.

For help, call: 888-963-7111, ext. 2645 or ext. 6030. 
   
Question: What is the Newborn Screening Report Card?
Answer:

The Newborn Screening Report Card provides a monthly report on your facility’s NBS submissions; including number of specimens submitted and specific information on specimen quality and demographic issues.

Refer to the Guide to the Newborn Screening Report Card (PDF 111kb) for more information on each category.

Access to the report allows the facility to:

  • Identify strengths and opportunities for improvement.
  • Compare your facility’s performance with others in the state.

To access your facility’s report card, you must be a registered user of the Texas Newborn Screening Web Application (Neometrics). If you are not already a registered user, you can sign up to become a registered user of the Texas Newborn Screening Web Application.
   
Question: I have forgotten my password or been locked out of my web account. What do I do?
Answer: Send an email request for a password reset to help@hhsc.state.tx.us. Business hours for assistance are 8am-5pm Monday through Friday.
   
Question: When will results be available through the Web Application?
Answer: Results will be available in the web application 4 to 7 working days (Monday - Saturday) after receipt of the specimen, in most cases.
   
Question: How long will the results be available on the web?
Answer: Results will be available indefinitely. Currently, users can access results for any specimens reported after mid-February of 2007. To access result reports for earlier specimens, providers must contact the DSHS Laboratory Reporting Group (fax 512-776-7533 or call 512-776-7578).
   
Question: We no longer wish to receive a hard copy of the result report. How do we opt out?
Answer: Call DSHS Laboratory Reporting at 512-776-7578 to request to opt out of hard copy reports.
   
Question: When trying to view a result report, I am receiving the error "The file is damaged and could not be repaired" Why?
Answer: To view result reports, the web application requires Adobe Reader 8.0 or higher. If you have an older version, this error will occur. Update your version of Adobe Reader.
   
Question: I am a provider treating a child and a registered user of the Web Application. Can I access reports on specimens that were sent to DSHS by a different provider for the child?
Answer: Yes. In the Access Result Reports module, uncheck Submitted Samples Only before performing a search. For additional security purposes, the user must use a combination of multiple search fields to access the result report. Recommended search criteria for SRV criteria. (PDF 22kb).
   
Question: I am having trouble accessing results. Where can I get help and hints for accessing result reports?
Answer:

The web application includes features that maximize patient privacy and ensure compliance with HIPAA Security rules.

If you are having trouble accessing results for a patient, check out the general SRV search tips (PDF 22kb) or send an email request for assistance with the website to: mailto:NBSRemoteDataServices@dshs.state.tx.us.

A few quick reminders:

  • Search with as few fields filled in as possible.
  • If there are any differences between what is searched for and what is in the system, results will not be retrieved.
  • The search combinations outlined in the Search Tips document (linked above) are the ONLY combinations allowed when searching for results for specimens that were not submitted by your facility.
  • When searching for results for specimens submitted by another facility, you must un-check the “Submitted Samples Only” box.
   
Accessing and Interpreting Result Reports (for Healthcare Providers)
Question: How do healthcare providers get result reports in addition to receiving them through the mail?
Answer:

1.    (Recommended) Sign up as a registered user of the Texas Newborn Screening Web Application and access reports online (see FAQs for Accessing Newborn Screening Result Reports Online (for Healthcare Providers), or

2.    Contact DSHS Laboratory Reporting Monday - Friday 8am to 5 pm.

  • Send a fax request to 512-776-7533 or
  • Call 512-776-7578.
   
Question: Our facility received an unsatisfactory report on a specimen, but the baby is no longer in our care. What should we do?
Answer: DSHS will ONLY notify the submitting facility of an unsatisfactory specimen. Facility’s receiving an unsatisfactory report for a specimen should either recall the patient for a redraw or coordinate with the patient’s current healthcare provider to ensure that a satisfactory newborn screening specimen is collected.
   
Question:  Our facility needs to make a correction to a result report (i.e., medical record number, name or other information is incorrect); what is the best way to request an update? 
Answer: 

To make a correction to demographic information on a newborn screening result report:

1.    Draw a line through the incorrect information on the result report.

2.    Write the correct information above or below the incorrect information.

3.    Initial, date and fax the result report back to: DSHS Laboratory Reporting, 512-776-7533.


A revised result report will be mailed or faxed to the facility that submitted the specimen. Corrections to information on a result report can only be requested by the facility that submitted the specimen. 

Please note:

  • Corrections made to the date of birth, date of collection and/or birth weight on a result report may cause changes in test results. Please be mindful of any updates to results.
  • Any requested change that calls into question the identity of the specimen (i.e. name changes or multiple field updates) will be deemed unacceptable and the results updated to UNSATISFACTORY: PATIENT INFORMATION INCOMPLETE OR INVALID. If a submitting facility is unsure of the identity of a specimen due to possible miss-labeling of the newborn screening demographic form, the DSHS Laboratory should be notified and any infant in question should have their newborn screen recollected. 
   
Question: What are analytes?
Answer: An analyte is the specific enzyme, chemical, or molecule that is tested for and measured to identify a child at risk for an NBS disorder. Many of the analytes are listed by name. For example, phenylalanine is the analyte measured which indicates PKU, thyroxine (T4) is the analyte measured which indicates hypothyroidism, and immunoreactive trypsinogen (IRT) is the analyte measured which indicates cystic fibrosis. However, Fatty Acid and Organic Acid disorder analytes are listed by abbreviations of the acylcarnitine markers or ratios that identify the disorder (e.g., C8, C6, C10:1 and C10 are the analytes that are measured and may indicate the MCAD disorder).
   
Question: For abnormal test results, are we responsible for ordering the confirmatory tests, or will the specialist order them? If we have to order the tests, what laboratory do you suggest we use?
Answer: The suggested confirmatory tests are listed in the result reports so that if you wish to order the tests before the specialist is consulted, you can do so. Some people prefer to consult with the specialist first and have the specialist order the tests. The laboratory used will depend on insurance requirements and local availability.
   
Question: Why do some abnormal results only require a repeat screen and others require other additional laboratory tests?
Answer: The requested or recommended actions are based on the concentrations of the abnormal analytes. The majority of abnormal analyte results only indicate the need for a repeat screen; however, some results are within a critical range and require immediate action to identify, prevent or control serious health problems.
   
Question: What does an Indeterminate Cystic Fibrosis (CF) screen result mean on the newborn screen result report?
Answer: The Texas Newborn Screening Program requests the collection of blood spots on two separate occasions for each baby. First screen specimens should be collected after 24 hours but before 48 hours of age, and the second screen specimens should be collected at one to two weeks of age. The IRT/IRT/DNA screening model used in Texas will identify babies with a persistent elevation of IRT. If the IRT level is elevated on the first screen, the NBS result report will list the CF result as "indeterminate", pending results from the second newborn screen. Therefore, please ensure that the second screen is promptly collected for any baby with an "indeterminate" result on the first screen.
   
Question: What does an Inconclusive CF screen result mean on the newborn screen result report?
Answer: With the IRT/IRT/DNA model used in Texas, newborn screens are tested for a panel of 40 DNA mutations when the second screen has an elevated IRT result or if the first screen is elevated and a second screen is not received by DSHS. If none of the 40 mutations are detected by the DNA testing, the newborn screening result report will list the CF result as Inconclusive. Although the mutation panel tests for the 40 most common Cystic Fibrosis Transmembrane Reductase (CFTR) gene mutations, there are more than 1600 known mutations in this gene. Therefore, even with the absence of these 40 mutations, there is still a minimal risk for CF. No further testing is recommended unless the child shows clinical symptoms of cystic fibrosis.
   
Question: When an abnormal result note states “Possible metabolic disorder,” what does this mean?
Answer: Sometimes, the screen results do not provide enough information to determine the exact disorder that may be indicated. Typically, the results do not indicate a critical situation so the action needed is to collect and submit a repeat screen as soon as possible.
   
Question: Why does the Screening Result indicate “Abnormal” but some analytes are listed as “Normal” in the Analyte Result” column?
Answer: Multiple analytes are used to determine a patient’s risk for some disorders. Not all the analytes have to be abnormal to indicate a problem.
   
Question: What does it mean when some result notes mention Non-Specific Elevation(s)?
Answer: Non-Specific Elevation(s) or Elevations in a non-diagnostic pattern refers to abnormal analyte(s) that are not recognized as a specific pattern associated with one of the screened disorders.
   
Question: Why does the result report have two or more result notes with differing instructions? Which directions am I supposed to follow?
Answer: Depending upon the specific analytes that are elevated, multiple disorders may be indicated. Therefore, multiple screening notes may be printed. NBS Clinical Care Coordination staff will contact the healthcare provider to provide guidance on necessary actions and follow-up.
   
Question: I received a two page abnormal result report but the second page was blank. Is there information missing?
Answer: No information is missing. If all of the information on the report (including the list of disorders that are screened for) cannot fit on the first page, a second report page is automatically generated to provide the information.
   
Question: What does it mean when the newborn screening report states, "Possible TPN - Please repeat the Newborn Screen when TPN is discontinued?”
Answer: Some newborns have gastrointestinal systems that are too immature to absorb nutrients safely, and therefore receive their initial nutrient (amino acids, sugars and lipids) through intravenous (IV) feeding, which is called total parenteral nutrition (TPN). TPN may interfere with the newborn screen by causing elevated results for many of the analytes masking a true disorder. This is a particular concern with the Amino Acid Disorders. Please do not collect the newborn screening sample directly off the TPN line. Please remember to note on the specimen collection card when a child is on TPN.
   
Question: Some results state, “DNA Report to follow.” Do I have to order additional testing?
Answer: No. As part of the NBS program, certain DNA testing is automatically performed on specimens that test positive for specific disorders. Specimens that will have the DNA testing performed have the above note on the NBS report. The DNA report will be mailed separately when the testing is completed. There is no additional charge associated with this DNA testing.
   
Demographic Entry through the Texas Newborn Screening Web Application (for Healthcare Providers)
Question: Which label printers can be used with the system?
Answer: The following is a list of just some of the label printers that have been tested with this system. Other similar printers will likely be configurable as well.
  • Zebra LP2824
  • Zebra TLP 3742
  • DYMO LabelWriter 400 Turbo
  • Brother P-touch QL-5000
  • SII Smart Label Printer
   
Question: How do I configure the label printer and my web browser to ensure labels print properly?
Answer: For complete instructions for configuring your printer and web browser, go to http://wwwstage.dshs.internal/lab/nbsProviderWebInstallation.pdf
   
Question: Do we still have to handwrite the demographic information onto the cards?
Answer: No. If you place a web label on the NBS card, you do not have to complete the form.
   
Question: I entered the specimen information and clicked “Submit” but I need to change something. How do I do this?
Answer: Through the web system, you may re-access the submitted specimen using the Search option under the Enter NBS Demographics module. Choose to edit the demographics for the specimen in question. Make any necessary changes to the demographic information and submit the specimen again. You will then be prompted to print a label.
   
Question: How do I print more than one label?
Answer: If your printer is configured to initiate a print dialog at each print, there will be an option to choose the number of copies within that dialog. If you will always print multiple labels, the number of copies can be set in the printer preferences.
   
Question: Can I print labels on a laser printer?
Answer: Although the system is configured to print to a label printer, if you prefer to print to labels on a laser printer see directions located at: http://wwwstage.dshs.internal/lab/nbsProcedurePrintLabelWebApplication.pdf
   
Question: Is there a way to set the default printer so that I can print labels to the label printer, but also print to the regular networked printer from other applications?
Answer: There is not a default setting to automatically print labels to the label printer and other documents to the networked printer. If you have the default set to the label printer but want to print documents to another printer, you will have to either change the default printer to the laser one you wish to print to, or select the laser printer from the print dialog box.
   
Question: I am getting an ActiveX control error when I submit a specimen or try to print a label. How do I fix this?
Answer: Since this is a secure site, the site must be added to a list of acceptable sites under security settings for your web browser. This may require setup assistance from your facility’s IT department. The steps necessary to reconfigure this are also available in the document http://wwwstage.dshs.internal/lab/nbsProviderWebInstallation.pdf
 
Billing (for Healthcare Providers)
Question: Who will be billed for newborn screening test kits?
Answer: For insurance/self-pay test kits, DSHS will bill the person or facility that orders kits. No bill is sent for Medicaid, CHIP or charity care newborn kits.
   
Question: Wouldn't it be easier for DSHS to bill the patient?
Answer: DSHS considered billing patients, but found that administrative costs would more than double the cost of the service. Minimizing administrative costs by charging providers for screening kits represented the most cost-effective approach.
   
Question: What if the screening test kit is defective?
Answer: Each screening test kit qualifies as a medical device. If a kit does not perform as it should, please notify the DSHS Laboratory Quality Assurance group by email. DSHS will investigate, and kits found to be defective will be replaced free of charge.
   
Question: If DSHS requests a repeat newborn screen because a specimen was deemed unsatisfactory, will a screening test kit be provided free of charge?
Answer: For Insurance / Self-pay kits, healthcare providers will be required to purchase a replacement kit. Healthcare providers are responsible for ensuring the quality of specimens drawn. All screening kits for Medicaid-eligible, CHIP, and charity care newborns are provided free of charge to the healthcare provider.
   
Question: What CPT codes should be used to submit reimbursement claims to insurance companies for the newborn screening panel?
Answer:

S3620 for the original disorders

82016 Acylcarnitines; qualitative, each specimen  

82128 Amino acids; multiple, qualitative, each specimen

DSHS does not control how insurance companies operate or the reimbursement rates that are set, therefore each individual facility’s billing office should work out individual agreements with each insurance carrier. For additional information, see the Texas Medical Association (TMA).

Note: DSHS has no affiliation with TMA and the opinions and positions of TMA may not reflect the opinions and/or positions of DSHS.
   
Question: What additional CPT code(s) should be used to submit a claim for reimbursement of a newborn screen?
Answer:

CPT codes S3620, 82016, and 82128 are used for the NBS panel. The CPT codes for each individual test in the newborn screening panel are listed in the table below. However, if all of these codes are used simultaneously to submit a claim to an insurance company the resulting reimbursement may be significantly higher than the current cost of performing the NBS. Effective October 1, 2016, the cost of $55.24 will be charged by DSHS for each newborn screen.

CPT# * CPT Description
83498 Hydroxyprogesterone, 17-d
83020 Hemoglobin fractionation and quantitation; electrophoresis
82776 Galactose-1 phosphate uridyl transferase; quantitative: screen
84437 Thyroxine; total: requiring elution (e.g., neonatal)
83788 Mass spectrometry and tandem mass spectrometry (MS, MS/MS), analyte not elsewhere specified; qualitative, each specimen
82261 Biotinidase, each specimen
83520 Immunoassay, analyte, quantitative (e.g. for CF screen)
81479 Unlisted molecular pathology procedure (e.g. for SCID screen)

* These codes do not include the reflex testing that is performed on certain subsets of specimens determined to be out of range on the initial screen. The cost of the reflex testing is included in the cost for the screen.
   
Question: How does the facility determine the best way to submit reimbursement claims for the newborn screen?
Answer: Have your facility’s business manager/office contact each insurance carrier with which you deal and work out the logistics, processes and rates. It may be possible to add this new agreed upon information to the facility’s agreement/contract with the insurance company.
   
Fee Change  
 Question:The fee for the Newborn Screening test increased effective October 2016. Why is the fee increasing? 
 Answer:DSHS must increase the fee to recover the cost of providing the Newborn Screening specimen testing and follow-up services. Since the last review and revision of the newborn screening fee in 2011, the NBS panel has expanded with the addition of SCID and the 24 secondary conditions. Also, the cost and amount of testing chemicals and supplies and maintenance of testing instruments have increased.  
 Question: What is included in the fee and how is it determined?
 Answer: The fee includes direct costs such as testing chemicals, supplies, labor, specimen collection kits, laboratory information management system (LIMS) and instrument maintenance and indirect costs such as quality assurance, safety, building costs, courier service, administration, IT network and purchasing. The NBS fee also includes costs to perform clinical care coordination for out of range results. It is calculated using a procedure approved by the DSHS Chief Financial Officer in 2011. This method is used to determine all laboratory fees. 
 Question: Is it too late for me to comment on this increase?
 Answer: Yes. The proposed changes to the Texas Administrative Code for the Department of State Health Services Laboratories were published for public comment in the June 3, 2016 edition of the Texas Register.  The public comment period was 30 days and closed on July 3, 2016.
 Question:Is it still necessary to collect the second screen? 
 Answer:Yes. Both screens are required as listed in the Texas Administrative Code, Title 25 Section 37.56. Also, some of the disorders screened are more likely to be detected when the baby is more that one week old. 
 Question:Has the Texas Department of State Health Services (DSHS) informed insurance companies of the fee increase? 
 Answer: DSHS has posted notices about this fee increase and coordinated stakeholder meetings on January 7, 2016 and May 16, 2016 to facilitate discussions among representatives from Texas Department of Insurance, United Health Care, Humana, Texas Association of Health Plans, Texas Hospital Association, Texas Pediatric Society, Texas Medical Association and March of Dimes. DSHS does not control how insurance companies operate or the reimbursement rates that are set, therefore each individual facility’s billing office will need to update their facility’s agreements with each insurance carrier.  
  
Additional Healthcare Provider Questions
Question: 

What are the DSHS laboratory’s recommendations for meeting the College of American Pathologist (CAP) Newborn Screening Specimen Tracking requirement?

CAP# GEN.40545 Newborn Screening Specimen Tracking (Phase I)

For specimens being submitted to a remote testing laboratory for newborn screening for congenital disorders, there is a documented tracking system to ensure that all specimens are submitted in compliance with timing requirements and that a result or other appropriate notification is received indicating that the specimens were actually received.
Answer:

DSHS Recommended Solution:

Use the Texas Newborn Screening Web Application (Neometrics). Benefits include:

  • Provider can opt to enter patient demographic information (reduces miss interpretation of hand written information on the kits) and/or
  • Search and view/print newborn screening result reports 24/7

Two ways the Texas Newborn Screening Web Application (Neometrics) helps you meet the new CAP requirement for NBS tracking:

1.    Electronically submit the demographic information for each newborn screen (NBS) specimen to the DSHS Laboratory. Once the specimen is received and scanned into the Laboratory Information Management System (LIMS), it will appear as “merged” in the provider’s Texas Newborn Screening Web Application account.

2.    Search for any newborn screening specimen submitted and view or print the result report. The DSHS Laboratory Quality Assurance Group has consulted with CAP and confirmed that healthcare providers can meet the specimen tracking requirement by confirming receipt of a result report for each specimen submitted. (Note: Demographic entry of specimens as described in above option is NOT needed in order to view/retrieve result reports.)

If you are not already a registered user of the Texas Newborn Screening Web Application, access the required forms and learn more information on the benefits of signing up here:

Required forms:

Alternate manual method:

NBS submitters can also opt to maintain a list of each NBS specimen submitted to the DSHS laboratory in the form of a manifest and reconcile the list upon receipt of the NBS result report. (A manifest does not need to be forwarded to the DSHS Laboratory.)
   
Question:  Our facility has multiple locations; can we use one Submitter ID number for all of them? 
Answer:  Yes, if necessary, but this practice is highly discouraged.It is preferred that each site request/receive its own submitter number.

All supplies, patient results, mailed correspondence, and alerts will be sent only to a single address for the Submitter ID number given. Separate submitter IDs for separate locations improves the timeline for submitter receipt of test result reports and ability to track supply shipments. It will also help ensure that supplies are received specifically by the site that ordered them. 

Note: External links to non-DSHS sites are intended to be informational and do not have the endorsement of the Texas Department of State Health Services. These sites may also not be accessible to people with disabilities.


Last updated September 4, 2019