5 Colo. Code Regs. § 1005-4-4
Current through Register Vol. 47, No. 11, June 10, 2024
Section 5 CCR 1005-4-4 - LABORATORY TESTING, REPORTING AND FOLLOW-UP SERVICES FOR NEWBORN SCREENING AND SECOND NEWBORN SCREENING4.1 The Laboratory shall operate at least six (6) days per week. Specimen testing will be initiated by the Laboratory on the date of receipt or the next operating day following receipt of the specimen. Results will be sent to the named submitter for initial newborn screening and for second newborn screening. Results will be reported in a manner and on a timeline consistent with the urgency of intervention.
4.1.1 Reports of screen negative test results will be sent within seven working days.4.1.2 An attempt to report time-critical screen positive results will be made immediately, but in no case longer than 24 hours. Reporting may occur through the Department or its contractor. Attempts to report time-critical screen positive results will continue for up to 180 days.4.1.2.1 If a contractor is utilized by the Department, the contractor may receive identifying patient information, protected health information, named submitter information and attending health care provider information to the extent necessary to perform these duties and in the manner authorized by law.4.1.3 An attempt to report time-sensitive screen positive results will be made immediately, but in no case longer than 72 hours. Reporting may occur through the Department or its contractor. Attempts to report time-sensitive screen positive results will continue for up to 180 days.4.1.3.1 If a contractor is utilized by the Department, the contractor may receive identifying patient information, protected health information, named submitter information and attending health care provider information to the extent necessary to perform these duties and in the manner authorized by law.4.1.4 An attempt to report unsatisfactory specimens or specimens with equivocal results will be made immediately, but in no case longer than 48 hours.4.2 Follow-up Services The following rules apply to follow-up services, while recognizing that family participation in the follow-up support and assistance services is voluntary.
4.2.1 Timeframe for initiating services 4.2.1.1 For time-critical screen positive results, follow-up services will be initiated within four hours or the clinically-relevant timeframe authorized by the Department to prevent death or intellectual or other permanent disabilities.4.2.1.2 For time-sensitive screen positive results, follow-up services will be initiated within a clinically-relevant timeframe to prevent death or intellectual or other permanent disabilities. When required by the Department, follow-up services will begin with repeat or confirmatory testing.4.2.2 Repeat or confirmatory testing Repeat or confirmatory testing will occur when clinically necessary as determined by the Department. If, through repeat or confirmatory testing, the newborn screening result is screen negative, follow-up services will be discontinued after communicating the result.
4.2.3 Timeframe for providing referral services Referrals to specialists will occur in a timely manner so a parent or legal guardian may make a timely decision to respond to a time-critical screen positive result or a time-sensitive screen positive result. All referrals must occur within the first 28 days of age unless, at its discretion, the Department may extend follow-up services beyond 28 days of age when repeat or confirmatory testing, diagnosis, interventions have created necessary delays to the Department's ability to provide referral services or exceptional circumstances exist. In no instance will follow-up services continue beyond 365 days of the child's birth.
4.2.4 If a contractor is utilized by the Department to perform follow-up services, the contractor may receive identifying patient information, protected health information, named submitter information and attending health care provider information to the extent necessary to perform these duties and in the manner authorized by law.4.2.5 Monitoring participation in follow-up services The Department shall monitor: 4.2.5.1 The number of newborns with a screen positive result who opt to not participate in follow-up services;4.2.5.2 The number of newborns with a screen positive result who receive repeat and confirmatory testing when clinically necessary;4.2.5.3 The number of newborns with a screen positive result who receive referral services;4.2.5.4 The number of newborns with a screen positive result who move out of state, withdraw from or do not participate in follow-up services, and;4.2.5.5 Such other monitoring the Department deems appropriate to monitor the effectiveness of newborn screening, second newborn screening and follow-up services.4.3 If a contractor is utilized by the Department, the contractor may receive identifying patient information, protected health information, named submitter information and attending health care provider information to the extent necessary to perform these duties and in the manner authorized by law.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