SECTION 310:550-19-1. Physician reporting and medical records

(a)   If confirmatory or follow-up testing is not performed by the Newborn Screening Laboratory or through a contract laboratory designated by the Newborn Screening Program, the infant's physician must report to the Newborn Screening Program Coordinator the results within seven (7) days after the completion of the medical evaluation, using the Department's Newborn Screening Report Form provided by the program.

(b)   The report form shall include infant's name, date of birth, newborn screening laboratory number, mother's name, final diagnosis, notation of initiation of treatment and start date, notation of referral to pediatric sub-specialist, notation if family was referred to other services, printed name and signature of physician determining diagnosis, telephone number and date form is completed. A copy of the confirmatory test results must accompany the report form.

(c)   For all diagnosed cases of phenylketonuria, congenital hypothyroidism, galactosemia, sickle cell diseases, cystic fibrosis, congenital adrenal hyperplasia, medium-chain acyl coenzyme A dehydrogenase deficiency (MCAD), biotinidase deficiency, amino acid disorders, fatty acid oxidation disorders, organic acid disorders, severe combined immunodeficiency (SCID), spinal muscular atrophy (SMA), x-linked adrenoleukodystrophy (X-ALD), mucopolysaccharidoisis type I (MPS I) and pompe disease upon completion of laboratory validation studies, establishment of short-term follow-up services, and approval by the Commissioner of Health, the infant's physician shall report treatment date if applicable, and referral information to the Newborn Screening Program Coordinator by completing the Department's Newborn Screening Report Form provided by the program.

(d)   These reports shall be confidential and may be utilized only for the purpose of ensuring service delivery, program administration, data analysis, and evaluation.

(e)   On request, a birthing facility or health care provider shall make available to the NBS Program or Oklahoma Birth Defects Registry:

(1)   Medical records;

(2)   Records of laboratory test; and

(3)   Any other medical information considered necessary to:

(A)   Determine final outcomes of abnormal CCHD screening results; and

(B)   Evaluate CCHD screening activities in the State; including:

(i)   Performance of follow-up evaluations and diagnostic tests;

(ii)   Initiation of treatment when necessary; and

(iii)   Surveillance of the accuracy and efficacy of the screening.

(f)   Information that the Department receives under this chapter is confidential and may only be used or disclosed:

(1)   To provide services to the newborn infant and the infant's family;

(2)   To study the relationships of the various factors determining the frequency and distribution of CCHD;

(3)   For State or federally mandated statistical reports; and

(4)   To ensure that the information received by the Department is accurate and reliable.

[Source: Amended at 8 Ok Reg 3115, eff 7-12-91 (emergency); Amended at 9 Ok Reg 1475, eff 5-1-92; Amended at 12 Ok Reg 41, eff 10-5-94 (emergency); Amended at 12 Ok Reg 1685, eff 6-12-95; Amended at 15 Ok Reg 121, eff 10-15-97 (emergency); Amended at 15 Ok Reg 1979, eff 5-26-98; Amended at 21 Ok Reg 1286, eff 5-27-04; Amended at 25 Ok Reg 105, eff 10-2-07 (emergency); Amended at 25 Ok Reg 1153, eff 5-25-08; Amended at 31 Ok Reg 1596, eff 9-12-14; Amended at 36 Ok Reg 1688, eff 9-13-19]