Timely collection of initial newborn screening blood specimens is key to promoting positive health outcomes in infants. Current regulations require that initial newborn screening blood specimens be collected from every newborn between 24 and 36 hours of life. Any initial specimen collected at more than 120 hours of life is considered a serious delay to screening that has the potential to negatively impact the health of the infant. If a delayed collection case is detected, the newborn screening coordinator at the hospital of birth will be contacted to fill out a late collection follow-up form with an explanation for delayed collection. Please keep an eye out for these forms, and if you receive one, please return the completed form to the newborn screening program in a timely manner. We appreciate your cooperation to ensure every newborn receive a timely screen.

As always, we are so impressed by your dedication to the families and newborns in New York State, especially during this challenging time. Should your birthing facility face a temporary suspension of services, or any significant changes, as a result of COVID or any other reason, please notify us as soon as possible via nbsinfo@health.ny.gov or by calling us at 518-473-7552.

Please be sure to contact the Newborn Screening Program as soon as possible when there are any changes in hospital staff/responsibilities. Having accurate hospital contact information is vital in ensuring that PCPs and families are notified of abnormal newborn screen results in a timely manner. Additionally, please remember to update the Hospital Contacts and Designee Form through the Health Electronic Response Data System (HERDS) application in the Health Commerce System.

The following changes to follow-up procedures are effective October 15, 2020:

• Specimens collected at < 24 hours of age are considered unsuitable and will only be followed up on by NBSP staff for babies not in the NICU. Previously NBSP staff followed up on unrepeated < 24-hour screens for babies in the NICU.  As stated in part 69-1.3 (c) (3) of the regulation, “Newborn Screening for Phenylketonuria and Other Diseases,” Subpart 69-1 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations, it is the responsibility of the birth hospital’s CEO to ensure that babies admitted to the NICU receive a second screen at 48-72 hours of life. 

• Specimens of suboptimal quality that require repeat specimens to ensure adequate screening will no longer be followed up on by NBSP staff.  As stated in parts 69-1.3 (c) and 69-1.3 (f) of the regulation, it is the responsibility of the birth hospital’s CEO to ensure that satisfactory specimens are collected and submitted to the NBSP in the appropriate timeframes and when informed that a specimen is poor quality, to ensure the baby’s parents and pediatrician are notified within one business day.

Since June 1, 2020 babies are screened for galactosemia using only the determination of the presence of galactose-1-phosphate uridyl transferase (GALT) enzyme activity. If absent, the GALT gene is sequenced.  Total galactose concentration is no longer tested as part of galactosemia screening.

Please use “Case demographics” in the newborn screening application available through the Health Commerce System to enter notes with case updates and upload images. Both updating PCP information and adding baby’s full name are particularly helpful in ensuring that babies who require repeat screens get them. If you need assistance using this application, please email nbsinfo@health.ny.gov.

NICU Interventions: If a newborn requires transfusion or TPN, the hospital should collect a newborn screening specimen prior to any transfusion or administration of TPN. If newborn screen is collected prior to RBC transfusion, was screen negative or detected a trait, no follow-up is needed. If a specimen was not collected prior to RBC transfusion, the baby was not screened for Hemoglobinopathies, Galactosemia, or Biotinidase Deficiency and should be monitored for signs of these disorders.

Three specimens should be collected from premature (<2000 grams) and/or sick infants requiring care in the neonatal intensive care unit (NICU):

1) A specimen should be collected upon admission to a NICU or special baby care unit. Every effort should be made to obtain the specimen prior to red blood cell (RBC) transfusion and/or administration of total parenteral nutrition (TPN).

2) Collect a second specimen when the infant is 48-72 hours of age. This specimen should be collected even if the infant had an RBC transfusion or was administered TPN.

3) A third specimen is required at discharge or 28 days of age, whichever comes first.

Due to COVID-19 we understand that collecting repeat screens is a challenge as many families are unable to return to the nursery or lab for testing.  In response we modified many of our repeat request reports to include risk information so that providers can prioritize those that need repeat screens as soon as possible, versus those for whom a repeat is recommended when it is safe and practical to do so.

We have received many questions about the impact on the newborn screening process related to the COVID-19 public health crisis. Please see a list of FAQs on our website. As always, we are so impressed by your dedication to the families and newborns in New York State, especially during this challenging time. Please do not hesitate to reach out via phone (518-473-7552) or email (nbsinfo@health.ny.gov) if you have additional questions.

December 2019

It has come to our attention that UPS has not been picking up newborn screening specimens from some hospitals due to concerns related to COVID-19. Please monitor your packages closely and notify us at nbsinfo@health.ny.gov as soon as you notice a missed pick up.

November 2019

If a repeat newborn screen is required due to unsuitable for testing, borderline or indeterminate results, it is the responsibility of the hospital of birth to ensure that a repeat specimen is collected as soon as practicable. If a repeat specimen is not obtained, the hospital of birth is required to submit written documentation to the Newborn Screening Program summarizing their efforts made to obtain a repeat specimen. This is required per NYS public health regulations.

October 2019

Starting March 2, 2020, specimens will be screened for congenital hypothyroidism using TSH only, and T4 testing will be discontinued. Primary congenital hypothyroidism can be detected via either a primary T4 or primary TSH assay. The primary TSH screen does not detect central hypothyroidism, however, this condition is not on the Recommended Uniform Screening Panel. Implementation of a primary TSH screen will allow most critical TSH results to be available on the day the specimen is received and will also reduce the recall rate.

September 2019

When completing blood collection form please be sure to supply all requested information, including the check boxes for gender, birth order, and NICU status. This information helps the Newborn Screening Program identify and locate babies in need of additional testing accurately and in a timely manner.

August 2019

Please do not refer to Newborn Screening as “the PKU test”. PKU is one of 50 different conditions screened at birth in New York State. Referring to it as “the PKU” causes confusion for both parents and providers which can lead to unnecessary and incorrect lab work for babies, as well as delay of proper lab work and treatment.

July 2019

When completing blood collection cards, please remember to ensure that 4-digit military time is used. Cards completed using standard time often are misidentified as less than 24 hours specimens. This could result in incorrect test interpretation, delayed results for several disorders, and collection of unnecessary repeat newborn screens.

June 2019

Effective September 3, 2019 the Newborn Screening Program will no longer mail paper copies of abnormal newborn screen results to birth hospitals. Both screen negative and screen positive results can be accessed electronically through the Health Commerce System’s Newborn Screening Applications using the following process:

1. Go to Health Commerce System/Newborn Screening Applications/Secure Remote Viewer

2. Select the name of the birth hospital and a “date reported”.

3. Click on “Check All”, scroll down and select “View Mailer”. A PDF file will be generated containing all the test results on the list.

To prepare for this change, please ensure that all staff responsible for processing screen positive results have an account for the Health Commerce System and have access to the Newborn Screening Applications. Please email nbsinfo@health.ny.gov if you have any questions.

May 2019

The “Newborn Screening for Phenylketonuria and Other Diseases,” Subpart 69-1 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations, was revised and went into effect in February 2019. To inform healthcare providers of changes in the regulation, the newborn screening program will be conducting an educational webinar series. The regulation will be divided into six topics, each with its own webinar: 1) Collection, Shipping, Tracking and Resulting; 2) NICU Collection; 3) Requests for Repeat; 4) Process Improvement; 5) Referrals to Specialty Care Centers and 6) Birth Attendants. The webinar series will be conducted on Thursdays at noon starting on September 5, 2019 and continuing through October 17, 2019. Recordings of the webinars will be posted on the newborn screening website: https://www.wadsworth.org/programs/newborn/screening.

April 2019

When completing mother’s address on the blood collection cards, please be sure to include the apartment number, if applicable. This information allows the newborn screening program to mail parents important information regarding their newborn in a timely manner.

March 2019

The Hospital Contacts and Designee Form, which must be completed annually and whenever there are any changes in hospital staff/responsibilities, should now be submitted through the Health Electronic Response Data System (HERDS) application in the Health Commerce System. Directions for completing this form are on the newborn screening website: https://www.wadsworth.org/hospital-contacts-and-designee

Please note: Once the form is completed and saved, the hospital CEO must also log in and add the HERDS application to review and submit the form. Because the hospital CEO is responsible for assigning designees, they are the only person that can submit the form.

February 2019

With the changes to the newborn screening regulations effective February 2019, samples are to be collected by 36 hours of age and the age at collection will be assessed using this timeframe on reports starting March 2019.  Please look for our webinar series coming this summer for more information.

As a reminder, be sure to place a UPS shipping label on the white Interior Security Pack.  If the pack is separated from the UPS envelope, specimens can still be delivered.

Please note: Some fields have now been removed from all screen negative newborn screen reports. These new reports are consistent with Clinical Laboratory Evaluation Program (CLEP) requirements.

January 2019

The Weitzman Institute and the New England Regional Genetics Network recently began a five part “Genetics in Primary Care” webinar series which focuses on the application of genetics services to primary care practice. Newborn screening is the topic of the first two webinars. These webinars aim to describe the history of newborn screening and the significance of an abnormal result, discuss how new disorders are added, define the role of the primary care physician in the newborn screening process, and provide adapted case studies for review. If you are interested in viewing these webinars they are available at the following link: https://www.weitzmanlearning.org/our-services/genetics/previous-webinars/

December 2018

New York State’s new regulations for newborn screening went into effect on February 13, 2019.

Included in these new regulations are:

• Specimens must be collected within 24-36 hours after birth and must be submitted to the laboratory within 24 hours after collection.
• All specimens should be air dried on a flat surface for at least 3 hours prior to forwarding to the testing laboratory.
• If a newborn is transferred to another hospital, the birth hospital must collect a specimen before transfer and notify the receiving hospital that a specimen was collected.  The receiving hospital will collect any repeat specimens required by the laboratory. If the newborn is less than 24 hours of age when the birth hospital collects the initial specimen, the receiving hospital will collect a repeat specimen 48-72 hours after birth.

November 2018

Starting on December 1st the NBS program began using a new immunoassay to detect exposure to HIV antibodies. This new assay detects the presence of both HIV-1 and HIV-2 antibodies.

October 2018

The last shipment of Newborn Screening UPS envelopes is currently being mailed out. Going forward, hospitals should order the standard UPS Windowed Express envelope (Item# 010195103) at no charge directly from UPS while in CampusShip. Instead of creating the label, click on “Quick Start” in the upper left-hand corner of the page. Then click on “Order Supplies.” Hospitals will need to provide UPS with their account number. If any problems/questions, contact UPS Customer Service at (800)-742-5877.

September 2018

When completing blood collection cards please be sure mother’s contact information is up to date and written as neatly as possible. This information allows families of infants with emergency newborn screen results to be contacted quickly. If the card is inaccurate or incomplete it can delay necessary treatments.

August 2018

New guidelines indicate specimens should be dried flat, away from light and heat, for 3 hours and placed in the white security packs before packing into the UPS envelopes.

July 2018

Did you know that three new disorders are being added to the New York State panel? Starting on October 1, 2018, the program will begin screening for

• Spinal Muscular Atrophy (SMA), a neuromuscular disorder
• Guanidinoacetate Methyltransferase (GAMT) deficiency, a cerebral creatine deficiency disorder
• Mucopolysaccharidosis, type 1 (MPS-I/Hurler syndrome), a lysosomal storage disease

The addition of these disorders to the newborn screen will allow babies with these conditions to be detected and treated as early as possible.

June 2018

Did you know samples sent by primary care providers in 2018 were received at the Newborn Screening Program an average of 6 days after collection? Many samples received from primary care providers after a request for a repeat sample are sent via US mail. Samples should be sent via an overnight courier, but due to the number of primary care providers, it is not feasible to set up newborn screening UPS accounts for them. Delayed repeat samples are a health risk for newborns. Also, samples received greater than 14 days from collection are not suitable for testing. We recommend hospitals develop a procedure to collect and ship requested repeat samples with other newborn specimens whenever possible to avoid delays.

May 2018

The NBS Program receives samples on Saturdays, which are processed first thing Monday morning. Emergency results for these specimens are typically available on Monday. To ensure critical results are available as soon as possible, all shipments created EVERY Friday need to be scheduled for Saturday delivery.  When the shipping label is created in the UPS system, under “how would you like to ship, select the “Deliver on Saturday” check box. If this process is not followed, critical results may be delayed until Tuesday.

April 2018

The monthly reports are intended to be a tool for continuous quality improvement and performance monitoring. We suggest hospitals use this tool to monitor the trends of their performance from month to month. If you notice a negative shift in your performance or your ranking, please thoroughly evaluate your newborn screening protocols and practices to identify improvement opportunities. Please note that ranking can be deceiving as many hospitals are now achieving 100% compliance with timeliness and specimen quality. Each month we receive many questions about these reports, including requests for additional information. As Mary Graziano has retired, please email these inquiries to NBSinfo@health.ny.gov to the attention of Rhonda Hamel and allow 1-2 weeks for a response. Please watch for additional information on frequently asked questions in the coming months.

March 2018

If a repeat newborn screen is required due to unsatisfactory, borderline or indeterminate results, the hospital of birth is required to ensure that a repeat specimen is collected by the hospital or physician caring for the baby. If a repeat specimen is not obtained, the hospital of birth is required to submit written documentation to the Newborn Screening Program summarizing their efforts made to obtain a repeat specimen.

February 2018

Do you call “Newborn Screening” the “PKU test”?

The test now screens babies for more than 40 conditions besides PKU. Calling it the PKU test can lead to confusion by parents and even lead to wrong follow-up testing after an abnormal screen for another condition.

January 2018

As part of a quality improvement process, the Newborn Screening Program reviewed issues with incoming UPS envelopes from hospitals.

• Missing transport forms or similar specimen manifest
  • Increases the risk of unscreened infants
  • Decreases assurance that all listed specimens were received
  • Decreases your ability to recall infants if an envelope is lost in transit
• Envelopes stapled shut
  • Increases the risk of injury to NBS staff
• Individually enveloped/bagged specimens within a single envelope
  • Delays the processing of specimens

All hospitals should review their packing and shipping procedures. Issues will continue to be monitored with notification to non-compliant hospitals’ executive staff.

October 2017

Don’t assume no news is good news.  We recommend birth hospitals and pediatric care providers have a system in place to track NBS results for each newborn.

Hospitals: Keep a log of each newborn’s Lab I.D. and the results of the screen. The newborn screening lab I.D. number should be communicated to the baby’s doctor as part of the discharge paperwork

Pediatric care providers: Check for the newborn’s result at the two-week visit.

September 2017

There is no longer a need to wait until 24 hours after the first feeding to collect the first specimen from newborns.  This protocol is out of date and impacts turnaround times.  Collect first specimens 24-36 hours after birth.

July/August 2017

Three specimens should be collected from premature (<2000 grams) and/or sick infants requiring care in the neonatal intensive care unit (NICU):

A specimen should be collected upon admission to a NICU or special baby care unit. Every effort should be made to obtain the specimen prior to red blood cell transfusion and/or administration of total parenteral nutrition.  Please only mark transfusion on the blood collection card if the infant was given red blood cells (RBCs) prior to specimen collection.
Collect a second specimen when the infant is 48-72 hours of age.  This specimen should be collected even if the infant had a RBC transfusion or was administered TPN.
A third specimen is required at discharge or 28 days of age, whichever comes first. 
If a specimen is not collected prior to RBC transfusion, a sample should be collected four months after the final RBC transfusion.

May 2017

Congenital hypothyroidism is the most common disease identified by newborn screening.  Stanford Medicine developed a free online CME course on diagnosing and treating CH. Check out this important resource. https://med.stanford.edu/cme/courses/online/hypothyroidism.html

April  2017

Please provide accurate information for the infant’s primary care physician on the blood collection card. We recommend identifying the infant’s anticipated primary care physician and asking for the physician’s phone number as part of the registration process.  When newborns have an emergency newborn screen result, this information is indispensable for getting them into care quickly.  This information can be life-saving.

March 2017

Do you want to know how to be successful at collecting suitable specimens and meeting timeliness benchmarks?  NYMAC is conducting a regional survey to develop recommendations for best practices by looking for trends in practices and performance.  If you haven't completed the survey yet, please complete it at: https://www.surveymonkey.com/r/NYMACHospitalSurvey.

This survey was previously sent to the NBS coordinator at each hospital. Please work together to submit one entry only per hospital.

February 2017

When submitting repeat specimens, please be sure to enter the previous LABID on the specimen collection form.
We encourage you to enter notes with case updates, view cases status (open/closed) and upload images by accessing an online application for communication about newborns with an abnormal newborn screen result.  “Case demographics” is one of the newborn screening applications available through the Health Commerce System.  If you aren’t currently using this application, email nbsinfo@health.ny.gov and request access.