1. (a) For those specimens identified by the Newborn Screening Area Service Center as early, or where the infant's age at time of specimen collection cannot be determined, the Newborn Screening Area Service Center shall verify with the collecting person or facility the dates and times of birth and specimen collection written on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409 -- (6/16)) NBS-I (F).

2. (b) Upon notification by the Newborn Screening Area Service Center that the specimen is verified as an early specimen, the perinatal licensed health facility staff, birth attendant, out-of-hospital newborn screening provider, or newborn's physician shall:

   1. (1) collect a repeat specimen within 48 hours of notification, using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409 -- (6/16)) NBS-I (F) pursuant to § 6501.5(a) and § 6504.4(b).
   2. (2) Ensure the specimen is given, on the same or next business day of the designated carrier, to a carrier contracted with the Department or contracted with a newborn screening laboratory or is transported by another same-day or overnight carrier to the assigned newborn screening laboratory.

3. (c) When the perinatal licensed health facility staff, the birth attendant, out-of-hospital newborn screening provider, or the newborn's physician is notified by the Newborn Screening Area Service Center that a specimen is an inadequate specimen, the perinatal licensed health facility, the birth attendant, out-of-hospital newborn screening provider, or the newborn's physician shall:

   1. (1) Collect a repeat specimen within 48 hours of notification, using the Instructions for Collecting Adequate Blood Specimens on the CALIFORNIA NEWBORN SCREENING TEST REQUEST FORM (NBS-TRF) (CDPH-4409 -- (6/16)) NBS-I (F) pursuant to § 6501.5(a) and § 6504.4(b).
   2. (2) Ensure the specimen is given, on the same or next business day of the designated carrier, to a carrier contracted with the Department or contracted with a newborn screening laboratory or is transported by another same-day or overnight carrier to the assigned newborn screening laboratory.
4. (d) If a repeat specimen for either an early or an inadequate specimen cannot be obtained, the perinatal licensed health facility staff, birth attendant, out-of-hospital newborn screening provider, or newborn's physician shall notify the Newborn Screening Area Service Center by phone, fax, or e-mail within 48 hours regarding the status of the collection and also again when the specimen has been collected and sent to the Department.
5. (e) Nothing in this section imposes the duty on the newborn's physician to find the infant if the infant is determined by the Newborn Screening Area Service Center to be lost to follow-up.

Note: Authority cited: Sections 124977, 124980, 125000, 125001 and 131200, Health and Safety Code. Reference: Sections 124975, 124980, 125000, 125001, 125025, 131050, 131051 and 131052, Health and Safety Code.

History

1. Change without regulatory effect adopting section filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

2. Amendment of section heading, repealer and new section and amendment of Note filed 4-4-2016 as an emergency; operative 4-4-2016 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2016, No. 15). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the Department of Public Health.

3. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 4-4-2016 order with amendments filed 4-17-2017. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2017, No. 16). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.

4. Amendment of subsections (a),(b)(1) and (c)(1) filed 6-6-2019 as an emergency; operative 6-6-2019 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977 (Register 2019, No. 23). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.

5. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 6-6-2019 order filed 9-30-2019. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2019, No. 40).