Code of Colorado Regulations
1000 - Department of Public Health and Environment
1005 - Division of Disease Dontrol and Public Health Response
5 CCR 1005-4 - NEWBORN SCREENING AND SECOND NEWBORN SCREENING
Section 5 - QUALITY CONTROL AND EDUCATION (PROMULGATED BY THE EXECUTIVE DIRECTOR)
Universal Citation: 5 CO Code Regs 1005-4 ยง 5
Current through Register Vol. 47, No. 5, March 10, 2024
5.1 The Laboratory shall have available for review a written quality assurance plan covering testing and reporting initial and second newborn screening specimens.
5.1.1
The written quality assurance plan will include monitoring the positive
predictive value of testing.
5.1.1.1 The
positive predictive value of testing shall be communicated by the Department to
improve the quality of initial and second newborn screening.
5.1.2 The written quality
assurance plan will include collecting data on newborns with a screen negative
result who are later determined to have a diagnosed condition which was
identifiable through screening.
5.2 The Laboratory shall make available educational materials and training concerning initial and second newborn screening specimen collection to all submitting agencies.
5.2.1 The Laboratory shall collect and
analyze quality indicators to monitor and inform the newborn screening process
including collection and transit of initial newborn screening specimens and
unsatisfactory initial newborn screening specimens. The data will be used to
implement quality improvement activities.
5.2.1.1 Quality indicators and performance
data shall be communicated by the Department to improve the quality of initial
and second newborn screening.
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