5 Colo. Code Regs. § 1005-4-5
Current through Register Vol. 47, No. 11, June 10, 2024
Section 5 CCR 1005-4-5 - QUALITY CONTROL AND EDUCATION (PROMULGATED BY THE EXECUTIVE DIRECTOR)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.42 CR 02, January 25, 2019, effective 2/14/201942 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202044 CR 07, April 10, 2021, effective 5/15/2021