Okla. Admin. Code § 310:395-5-18

Current through Vol. 42, No. 3, October 15, 2024

Section 310:395-5-18 - Newborn screening

(a) The Licensed Midwife shall ensure screening and testing of Newborns in accordance with 63 O.S. §§ 1-543 to 1-545; OAC 310:550; and these Rules.

(1) Blood Spot Screening:

(A) For all Newborns who are not born in a hospital, the Licensed Midwife shall collect and submit a satisfactory Newborn screening blood specimen as early as possible after twenty-four (24) hours of age;

(B) If the initial specimen is collected at or less than twenty-four (24) hours of age, the Licensed Midwife is responsible for ensuring a repeat screen is collected as soon as possible after twenty-four (24) hours of age. If a sample is not collected, the Licensed Midwife shall immediately notify the infant's physician, if available, parents, and the Newborn Screening Program at the Department;

(C) Specimens shall be obtained with a Newborn Screening Form Kit and be collected in accordance with the standard for Blood Collection on Filter Paper for Newborn Screening Programs, NBS01-A6, Sixth Edition, as adopted and published by the Clinical and Laboratory Standards Institute on July 31, 2013. Failure to follow these methods of blood collection may cause inaccurate results, or unsatisfactory specimen results, that require repeat collection;

(D) The Licensed Midwife shall implement a procedure to ensure that the Newborn screening blood specimen has been collected on every Newborn and transported to the Oklahoma State Department of Health Newborn Screening Laboratory within twenty-four (24) to forty-eight (48) hours of collection. Specimens should be transported in the manner designated by the Department and Newborn Screening Laboratory;

(E) The Licensed Midwife is responsible for ensuring that employees who collect, and/or handle Newborn screening blood specimens are informed of their responsibilities with respect to screening procedures; and

(F) Unless the Licensed Midwife has indicated another health care provider is providing follow up care for the Newborn on the Newborn Screening Form Kit, upon written notification by the Newborn Screening Program of follow up requirements for a Newborn screen result of abnormal, unsatisfactory, or for specimens collected from a Newborn at or less than twenty-four (24) hours of age, the Licensed Midwife or designee will ensure that required repeat screening, confirmatory testing, or diagnostic studies are performed in the timeframe specified so that therapy, when indicated, can be initiated expediently.

(2) Pulse Oximetry Screening for CCHD:

(A) All Newborns who are not born in a hospital should have a pulse oximetry screening performed between twenty-four (24) hours and forty-eight (48) hours of life utilizing an established protocol. A recommended protocol is provided by the Department;

(B) If the Newborn is screened between twelve (12) and twenty-four (24) hours of life, the Licensed Midwife shall notify the infant's physician, if available, of early screening. The pulse oximetry should not be done before twelve (12) hours of age;

(C) If pulse oximetry screening is not performed, the Licensed Midwife will notify the infant's physician, if available;

(D) A qualified and properly trained individual shall perform the pulse oximetry screening and the results shall be provided to the physician, if available, or other health care provider;

(E) The pulse oximetry screening result shall be recorded on the Newborn Screening Form Kit, along with the infant's name, date of birth, submitting facility or provider, mother's name, and the infant's physician, if available;

(F) If the Newborn is not screened for CCHD prior to the Newborn Screening Form Kit being forwarded to the Newborn Screening Laboratory for testing, the pulse oximetry screen result shall be communicated to the Newborn Screening Program Coordinator utilizing the Pulse Oximetry Screening Result Form provided by the Department;

(G) The Licensed Midwife is responsible for ensuring that employees who perform pulse oximetry screening are informed of their responsibilities with respect to screen procedures; and

(H) For abnormal pulse oximetry screen results, it is the responsibility of the Licensed Midwife or authorized health care provider who conducted the pulse oximetry screening to either contact a pediatric cardiologist for clinical recommendations including identification of a Referral facility or, if the Newborn is symptomatic, immediately refer infant to the closest emergency room for evaluation. CCHD Referral protocol is provided by the Department.

(3) Newborn Hearing Screening:

(A) All Newborns who are not born in a hospital should have a physiologic hearing screening utilizing either Automated Auditory Brainstem Response Testing (AABR), Otoacoustic Emissions Testing (OAE) within the first month of life or any new or improved techniques deemed appropriate for use in hearing screening procedures by the Commissioner;

(B) If a physiologic hearing screening is not performed, the Licensed Midwife is responsible for completing the risk factor screening portion on the Newborn Screening Form Kit and notifying the Newborn's physician, if available, that a physiologic hearing screening was not completed;

(C) A qualified and properly trained individual will perform the Newborn hearing screening and ensure that hearing screening results are made available to the physician, if available, or other health care provider;

(D) The Licensed Midwife or designee involved in the hearing screening procedure of a Newborn will forward results to the Department via the Newborn Screening Form Kit, fax, or secure email within one (1) week of performing the hearing screen;

(E) The Newborn hearing screening results shall be recorded on the Newborn Screening Form Kit, along with the infant's name, date of birth, submitting facility/provider, mother's name, and the infant's physician, if available, or provider;

(F) If the Newborn does not receive a Newborn hearing screening prior to the Newborn Screening Form Kit being forwarded to the Newborn Screening Laboratory for testing, hearing screening results shall be communicated to the Newborn Hearing Screening Program utilizing the Newborn Hearing Screening Reporting Form provided by the Department;

(G) The Licensed Midwife is responsible for ensuring that employees who perform Newborn hearing screening are informed of their responsibilities with respect to screening procedures; and

(H) The Licensed Midwife or designee involved in the screening of a Newborn will provide the parents with appropriate resource information to allow the Newborn to receive the medical, audiologic, and other follow-up services for the following reasons:

(i) Did not receive a physiologic hearing screening;

(ii) Referred on physiologic hearing screening; or

(iii) Considered as "at risk" for hearing loss.

(b) Refusal of screening: A parent or legal guardian may refuse the Newborn blood spot screening, hearing screening, and/or pulse oximetry screening of their Newborn on the grounds that such examination conflicts with their religious tenets and/or practices as described in OAC 310:550-3-1. Refusal of screening shall be indicated in writing utilizing the Newborn Screening Program Refusal Form provided by the Department. This signed refusal form shall be placed in the Newborn's medical record with a copy sent to the Newborn Screening Program.

(c) Maintaining records:

(1) Any Licensed Midwife who collects, handles, or forwards Newborn screening blood specimens shall keep a log containing the name and date of birth of the infant, name of the infant's provider, medical record number, serial number of the Newborn Screening Form Kit, date of specimen collection, date specimen was sent to the certified laboratory, date that the test results were received and the test results;

(2) If Newborn blood spot screening test results are not received by the Licensed Midwife within fifteen (15) days after the date of collection, the Licensed Midwife shall contact the Newborn Screening Laboratory to verify that a specimen was received. If a specimen was not received, the Licensed Midwife shall notify the infant's physician, if available;

(3) The chart copy of each Newborn screening kit, pulse oximetry screening results, and hearing screening should be placed in the Newborn's medical record and reported to the parent or legal guardian; and

(4) The Licensed Midwife should document in the Newborn's medical record if a sample is not collected.

(d) Parent, Legal Guardian and Employee Education:

(1) The Licensed Midwife or designee is responsible for ensuring that a parent or legal guardian of each Newborn is educated and provided written materials about Newborn blood spot screening, pulse oximetry screening, and Newborn hearing screening, and provide information about the disorders and how to obtain screen results from the planned health care provider or Newborn Screening Program; and

(2) The Licensed Midwife shall provide or arrange ongoing training for their employees involved with Newborn blood spot screening, pulse oximetry screening and Newborn hearing screening. Training should include methods of collecting a satisfactory Newborn screening blood spot specimen, information on the proper pulse oximetry screening method, and information on the proper Newborn hearing screening method.

Okla. Admin. Code § 310:395-5-18

Adopted by Oklahoma Register, Volume 38, Issue 06, December 1, 2020, eff. 11/2/2020

Adopted by Oklahoma Register, Volume 38, Issue 12, March 1, 2021, eff. 2/2/2021

Adopted by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021