(a) Collection and submission.

1. (1) Medical facilities/medical staff.

   1. (A) In all cases where the birth of an infant occurs in a medical facility licensed by the State Board of Health, it shall be the responsibility of the governing body and medical staff of the facility to adopt and enforce policies and procedures which ensure that blood tests for core medical conditions as listed in the RUSP are conducted and processed in accordance with this part.
   2. (B) The licensed facility shall also be responsible for submission of the usable blood specimen in cases where:

(i) An infant less than six (6) months of age is admitted (i.e., born out of hospital, neonatal transfer, etc.); and

1. (ii) It is brought to the attention of the facility or the attending physician that the infant is untested.

   1. (C)

      1. (i) If an infant is discharged from a licensed medical facility without collection and submission of a usable specimen for testing, it shall be the responsibility of the discharging facility and the attending physician to arrange for the testing.
      2. (ii) The discharging facility and attending physician shall notify the Department of Health within one (1) week of discharge if their efforts fail to arrange for testing.
2. (2) Physicians. Physicians assuming care of infants who are under six (6) months of age and who come to their attention as being untested or inadequately tested for core conditions as listed in the RUSP shall also be responsible for ensuring collection and submission of usable blood specimens for these infants.

3. (3) Licensed midwives.

   1. (A) In cases where the birth occurs outside a licensed medical facility or in the home, it shall be the responsibility of an attending licensed midwife to advise the parents of this law and the procedure for:

      1. (i) Conducting newborn screening; and
      2. (ii) Documenting that a blood sample is obtained after twenty-four (24) hours and no later than seventy-two (72) hours after birth.
   2. (B) If the blood sample is not obtained for any reason, an attending licensed midwife must document the incident in the patient’s chart.

4. (4) The department.

   1. (A) The department. The department’s Local Health Unit shall collect and submit usable blood specimens on all infants under six (6) months of age who come to their attention as being tested or inadequately tested.
   2. (B) This responsibility shall not be in lieu of that of the preceding individuals and facilities.

(b) Payment.

1. (1) The collector will be charged a fee of one hundred thirty-one dollars ($131) for the processing and testing of newborn screening specimens by the department.

2. (2) The board may determine the amount of this fee based on the department’s cost to process and test the specimens.

   1. (c) Laboratory analysis.
3. (1) The department shall be responsible for provision of forms and instructions for the blood specimen collection, processing, and recording of the specimen received, analysis of specimen, determination of abnormal results, and reporting of lab results within a time period which would allow preventive medical intervention.

4. (2) Testing for core medical conditions newly added to the RUSP shall begin within thirty-six (36) months upon introduction to the RUSP.

   1. (d) Follow-up.

5. (1)

   1. (A) The department shall be responsible for the interpretation of laboratory results and the reporting of abnormal results to the attending physician or birth attendant.
   2. (B) If the screening result is suggestive of a core medical condition as listed on the RUSP, the department shall consult with specialist physicians.
   3. (C) The department shall notify the collector of the specimen and enter the infant’s information in a tracking system maintained to evaluate program operations and infants’ medical outcomes.

6. (2) Attending physician/medical attendant.

   1. (A)

      1. (i) Upon receipt of a notice of an abnormal test result, the physician or medical attendant shall be responsible for the appropriate medical treatment, referral, and/or retesting within the timeframe specified by the department for that condition.
      2. (ii) It is strongly recommended that consultation be obtained with a physician who has special competence in the management of these conditions.

   2. (B)

      1. (i) The attending physician or other responsible healthcare provider who conducts testing in follow-up to abnormal screens shall report subsequent test results, whether negative or positive, to the department.
      2. (ii) To provide for long-term follow-up the department will collect data on affected infants each year for five (5) years to determine healthcare maintenance and health status, especially the presence of intellectual disability or permanent disability.
      3. (iii) The department will establish protocols for follow-up of all screened conditions in collaboration with medical specialists.
      4. (iv) For infants with abnormal test results, the physician will be notified of the results and informed of the recommended protocols for follow-up of the conditions.