Texas Department of State Health Services Newborn Screening Branch

Newborn Screening Program Specimen Collection Presentation January 2007

Texas Newborn Screening Table of Contents: The Specimen Collection Form Blood Sample Collection The Voice Response System

The Newborn Screening Specimen Collection Form

What is a screening test kit? The newborn screening test kit includes a specimen collection device, a form for demographic information and a special envelope.

How do I order lab supplies? CALL: 512 – 458 - 7661

Is the form we have current? The expiration date on all newborn screening kits is shown on the cover, demographic sheets and the filter paper.

Expiration Date

Expiration Date

Can I use the mother’s Medicaid number for the newborn? Yes. The mother’s Medicaid number may be used on the form to indicate that the newborn is Medicaid-eligible. DSHS recognizes that it may take months to issue a Medicaid number for the newborn.

Medicaid Eligible (1=Yes, 2=No) Medicaid No.

How does DSHS define charity care? The charity care newborn is a patient who is not insured and is not covered or eligible to be covered for newborn screening services by Medicaid or any other government program.

Specimen Collection Check List  Wear gloves when handling form.  Use black ink and print in block capital letters.  Use the same “baby’s last name” on the first and second filter collection form.

Specimen Collection Kit Cover Sheet Provider/Submitter Instructions: Complete Infant’s Last Name, First Name and Date of Birth

Specimen Collection Kit Cover Sheet (con’t.) Provider/Submitter Instructions: For 1st screen: Remove the PARENT COPY and give to the parent. Inform the parent that they MUST take this form to their infant’s doctor at the baby’s 1-2 week check-up.

Specimen Collection Kit Cover Sheet (con’t.) Provider/Submitter Instructions: For 2nd screen: Write the serial number from the 1st screen PARENT COPY (brought to you by the parent) in the box labeled “Serial Number” in the Newborn Information area of the demographic form for the specimen being submitted. Retain the PARENT COPY from the 2nd screen in the patient chart. If an additional screen is requested, use this serial number on the additional screen form.

Baby’s Last Name When filling out the filter collection form for the second screen, ask mom what name was used on the form for the first screen in the “Baby’s last name” box and use the same name. The NBS case management staff uses the baby’s last name, mother’s last name, and date of birth to link the second screen to the first. This information is vital for identification and location of infants for follow-up of abnormal tests results.

Gloves To prevent specimen contamination, do not touch any part of the filter paper circles before, during or after collection. Disposable gloves can contaminate the specimen and powdered residue from the gloves can contaminate the hands.

Why do I have to fill out all the information when I know the baby? It may be necessary to reach the family in a hurry when you are not available. Also, the State Laboratory receives so may specimens that often there are several babies with the same last name and the same birth date.

Why is it necessary to retest some babies several times? Premature babies may have immature enzyme systems or thyroid functioning. It may be necessary to monitor their progress to be certain they reach normal levels. AND

Total parenteral nutrition may cause a false positive result. A normal screen in an infant who has insufficient enteral intake does not rule out metabolic disease. Total parenteral nutrition may cause a false positive result.

Check List  Fill in both first and last name in the “Physician’s Name” box.  Use grams in the “Birthweight” box. (This information is crucial for newborn screening disorders because many interpretations of results are based on the birth weight of the infant).  Fill in the physician’s telephone number in the box directly below the medical record number box.

Birth Weight 1-800-252-8023 extension 2129 A free weight conversion chart is available from the Newborn Screening Program. 1-800-252-8023 extension 2129

Check List Mother’s social security number  Fill in the boxes for: Status Test Date of birth Date of specimen (specimen will be rejected without a date of collection) Infant’s age at specimen collection Mother’s social security number

Repeat Screen The NBS follow-up staff may contact submitters by fax, phone, and/or letter to request a repeat screen.

Check List Make sure all boxes are: legible, accurate, and complete.

What if the screening test kit is no good? Each screening test kit qualifies as a medical device. If a kit does not perform as it should, please notify the Quality Assurance Officer at 512-458-7318. DSHS will replace defective kits free of charge.

Will DSHS pay postage? DSHS has never paid postage for the newborn screening test kits and does not contemplate doing so in the future.

NBS Specimen Rejection Possible due to NEW POSTAL REGULATIONS Effective May 14, 2007 the USPS raised postage rates, and initiated new postage pricing rules based on mail size and shape.  The changes will require you to carefully evaluate your newborn screening specimen shipping practices to ensure that correct postage is used.  Envelopes with insufficient postage may be returned, leading to critical newborn screening delays or rejection of specimens.

General Information 1 specimen card in an envelope (Letter) used to cost $0.39 but will now cost $0.41 to ship. The price increases as you add cards. 6 cards or more will require the more expensive flat rate pricing. Envelopes with metal clasps will be charged an additional $0.17 surcharge if the clasps are used to close the envelope. Leave the clasp flat and close with tape only.

The following are examples only The following are examples only. Please verify exact postage from your facility. 1 specimen card in an envelope (Letter) will now cost $0.41 to ship. 2 specimen cards in an envelope (Letter) will cost $0.58 to ship. 10 specimen cards in an envelope (now considered Flats) used to cost $1.35 but will now cost $1.48 to ship.

Obtain a copy of the new pricing schedule for your Mail Zone at http://pe.usps.gov/

Collecting a Blood Sample

Equipment Sterile lancet with tip (2.0 – 2.40 mm) sterile alcohol prep sterile gauze pads soft cloth blood collection form gloves

Increase Blood Flow Wrap a warmed, moist towel around the heel puncture site for 3 to 5 minutes.

Positioning the infant with feet lowered below the heart will help to increase blood flow.

Cleanse site with sterile alcohol pad. Clean & Dry Cleanse site with sterile alcohol pad. Allow site to air dry. (Alcohol residue left on the skin may dilute the specimen and affect test results)

Hatched area indicates safe areas for puncture site.

Wipe away the first drop of blood with dry sterile gauze. Puncture Position a sterile disposable lancet (2.0 – 2.4 mm tip) or an automatic lancet at a slight angle to perform a swift clean puncture. Wipe away the first drop of blood with dry sterile gauze.

Fill Circle Allow a second large drop of blood to form. Lightly touch blood drop to filter paper. Allow blood to soak through and completely fill circle.

Fill Remaining Circles Fill remaining circles with successive blood drops. If blood flow slows, repeat procedure selecting a different site and using sterile equipment.

Why are so many specimens marked unsatisfactory when I can see plenty of blood in the circles? There must be an even penetration of blood for the test to be accurate. This means soaking through the filter paper with one application and filling the whole circle so the blood is evenly distributed on both sides of the filter paper.

Apply blood to one side of the filter paper only, allowing full saturation of each circle before proceeding to the next circle. To enhance blood flow during collection, very gentle intermittent pressure may be applied to the area surrounding the puncture site. Excessive “milking” causes an admixture of tissue fluids with the blood specimen, invalidating the specimen.

Do not layer successive small drops of blood on top of each other Do not layer successive small drops of blood on top of each other. Let each drop touch the paper about 1/8 inch away from the previous one. This prevents layering of the paper, which is one cause of unsatisfactory results.

Drying Specimen Allow the blood specimens to air-dry for at least 4 hours on a flat, nonabsorbent surface protected from heat or direct sunlight.

Do not refrigerate the samples or put in plastic sleeves Do not refrigerate the samples or put in plastic sleeves. (Plastic sleeves allow accumulation of condensation and can contribute to contamination, elution, and bleeding of the blood spots).

Place dried specimen collection form in special envelope and mail within 24 hours.

The Voice Response System

Voice Response System (VRS) The VRS provides 24-hour access to newborn screening laboratory information on all patients screened at the DSHS Laboratory.

Requirements: (1) Licensed Texas newborn screening submitter number (2) Personal identification number (PIN) (3) Newborn screening form serial number or social security number of infant’s mother (4) Touch tone phone

Instructions for use of the VRS are presented in logical order during the call. Interaction with the system is by means of the telephone key pad. Keys are identified as follows: Numbers……………………….1-9 and 0 Pound………………………….# Star…………………………….*

Information about the infant is presented as: Form serial number (from specimen form) Last name (spelled) Sex (male, female, unknown) Date of birth Test results Interpretation

How do I get a PIN number? Call: 512-458–7111 extension 6988 or 1-888-963-7111 Email: labappsupport@dshs.state.tx.us

May I receive a hard copy of the screen? Yes. An add-on feature to the VRS allows results to be sent via FAX to a physician requiring a hard copy of the voice session.

VRS Message A message may be repeated at any time by pressing the pound (#) key. After hearing results for an infant, you will be given the opportunity to speak with a member of the newborn screening staff. Then, or at any time thereafter during normal business hours (8:00-5:00), you may press the star (*) key to have your call transferred to a staff member. If you are calling after hours, or if all the lines are busy, you will be invited to leave a message with a member of the newborn screening staff.

Where do I find our submitter number? Call: 512 – 458 – 7111 extension 2421

Texas Newborn Screening Program Voice Response System 24 - HOUR ACCESS (512) 458-7300 or 1-888-963-7111 extension 7300

The Newborn Screening Program Case Management Staff can be reached at Telephone: 1- 800 – 252 - 8023 Fax: 512 - 458 -7450

For information regarding newborn screening results between the hours of 8:00 - 5:00, Monday - Friday you may call the DSHS Lab at 512 - 458 - 7578

FYI Cases confirmed by testing done at laboratories other than the Texas Department of State Health Services Laboratory must be reported to the Newborn Screening Case Management Program at 1-800-252-8023

Newborn Screening Literature Educational materials for providers and parents are available free of charge from the Newborn Screening Program. 1-800-252-8023 extension 2129 or Email: newborn@dshs.state.tx.us

Newborn Screening Website www.dshs.state.tx.us/newborn