Specimens will be rejected if they do not meet the quality standards of the Ohio Department of Health. These standards are in accordance with recommendations of the Clinical Laboratory Standards Institute (Refer: Blood Collection of Filter Paper for Newborn Screening Programs: Approved Standard – Sixth Edition – NBS01-A6).
Specimens can be considered unsatisfactory and rejected if three or more blood spots do not meet standards. A blood spot may be considered unsatisfactory for any of the following reasons:
- No blood on filter paper
- Insufficient quantity of blood for testing
- Incomplete saturation of blood through filter paper
- Supersaturated or layered blood on filter paper
- Blood directly applied to both sides of filter paper
- Blood appears clotted
- Diluted, discolored, or contaminated specimen or filter paper
- Excess serum or tissue fluids in specimen
- Filter paper appears scratched or abraded
- Blood spots not dried at least 3 hours prior to shipping
- Specimen received by laboratory more than 14 days after collection
- Kit number on filter paper does not match kit bar code number on demographic sheet
- Demographic information does not match blood (wrong baby drawn on card)
The facility responsible for submitting an unsatisfactory newborn screening specimen will be contacted by the Ohio Newborn Screening Program. The facility is responsible for assuring that a second newborn screening specimen is submitted for the baby within 5 working days.
Please remember that an unsatisfactory specimen delays the screening process by a week or more. This could adversely affect the health and development of a baby with a time-critical condition on the Ohio newborn screening panel.
Every effort should be made to collect a satisfactory specimen the first time. (Refer to How to Collect and Mail Blood Specimens for instructions.) Both the front and the back of the blood spots on the filter paper should be inspected immediately after specimen collection. If the specimen does not meet quality standards, recollect the specimen before the baby is 48 hours of age. Refer to chart below for examples of unsatisfactory specimens.