5 Colo. Code Regs. § 1005-4-1
"Birthing Facility" means a general hospital or birthing center licensed or certified pursuant to Section 25-1.5-103, C.R.S.
"Department" shall mean the Colorado Department of Public Health and Environment.
"Exceptional circumstances" shall mean circumstances within 364 days after the birth of the child, where the Department, at its sole discretion, may determine that timely collection of a specimen was not feasible, but screening remains appropriate. This includes but is not limited to obtaining specimens for children born outside the United States who relocate to Colorado through the adoption process or a refugee resettlement program.
"Follow-up services" shall mean 1) repeat or confirmatory testing if clinically necessary as determined by the Department, or 2) for newborns that screen positive initially or through repeat or confirmatory testing, referral services to connect newborns to the healthcare system for the purpose of receiving a diagnosis, interventions, or specialty care, as determined by the Department. Follow-up services supported or performed by the Department are intended to facilitate rapid connection of newborns to appropriate care, but are not intended to serve as clinical case management services.
"Initial newborn screening specimen" shall mean, absent exceptional circumstances, a specimen collected from a newborn, between 24 and 48 hours after birth and, to the extent feasible, prior to any blood transfusion.
"Laboratory" shall mean the Colorado Department of Public Health and Environment laboratory.
"Named submitter" shall mean the entity or individual identified on the demographic slip attached to the blood spot card as the submitter of that specimen.
"Newborn" shall mean a child under 28 days of age whose parent(s) or legal guardian(s) have not opted out of newborn blood spot screening. Newborns may be referred to as "neonates."
"Screen negative" shall mean a result from a screening test that does not indicate the presence of the screened condition.
"Screen positive" shall mean a result from a screening test that indicates some likelihood of the screened condition(s) being present, and therefore requires further investigation or testing of the newborn.
"Second newborn screening specimen" shall mean a specimen collected from a newborn between 8 and 14 days after birth for the purpose of conducting second screening tests.
"Specimen" shall mean any dried blood spots collected, dried, and submitted to the Laboratory for screening.
"Time-critical condition" shall mean a condition identified by the Department that may present with acute symptoms within the first week of life thereby requiring immediate treatment to reduce risk of death or intellectual or other permanent disabilities.
"Time-critical screen positive result" shall mean a positive screening result that suggests a high likelihood of a time-critical condition.
"Time-sensitive condition" shall mean a condition identified by the Department not to be associated with early onset of severe symptoms including death or intellectual or other permanent disabilities.
"Time-sensitive screen positive result" shall mean an initial newborn screening specimen result associated with any risk level for a time-sensitive condition or a moderate risk level for a time-critical condition, thereby allowing time for collection and testing of a second newborn screening specimen.
"Unsatisfactory specimen" shall mean a specimen for which all tiers of testing performed within the Laboratory could not be completed for any reason, such as the quality of the specimen or the amount of specimen provided.
5 CCR 1005-4-1