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(1) Each person in charge of any health care facility and each person responsible under ARM 37.57.307 for a birth occurring outside a health care facility must:

(a) ensure that a blood specimen is taken from each newborn for which the health care facility or person is responsible, in conformity with this subchapter, for the purpose of performing newborn screening tests;

(b) be certain that the specimen to be forwarded to the laboratory is adequate for testing purposes;

(c) within 24 hours after the taking of the specimen, cause such specimen to be forwarded to the department's laboratory by either courier or first-class mail or its equivalent;

(d) record in the newborn's medical record the date of taking of the test specimen and the results of the tests performed when reported by the department;

(e) ensure that pulse oximetry is performed per the department's recommended protocol for the purpose of performing newborn screening for CCHD as follows:

(i) ensure that the screening is performed on equipment that has been approved by the FDA for use on newborns and is motion tolerant;

(ii) ensure that screening is performed by licensed staff who have been trained on the screening procedure and protocol;

(iii) record in the newborn's medical record the date, time, and screening results;

(iv) ensure that the pulse oximetry screening results are reported to DPHHS as required by this subchapter;

(v) ensure that a policy and procedure is in place for immediate follow-up of a failed CCHD screen; and

(f) use educational materials provided by the department and must provide education to the newborn's family on the following:

(i) the conditions that may be detected through bloodspot screening and pulse oximetry screening;

(ii) the importance of newborn screening tests to detect potentially life- threatening conditions;

(iii) the process for collecting bloodspot screening and conducting pulse oximetry screening; and

(iv) after hearing all the benefits of newborn screening and the risks involved in refusing testing, a parent/legal guardian may refuse either of the above screenings. In that case, the parent/legal guardian must sign a waiver for the newborn's medical record in which they accept responsibility for adverse consequences. A copy of this waiver must be provided to the department.

History: 50-19-202, MCA; IMP, 50-19-203, MCA; Eff. 12/31/72; AMD, Eff. 5/6/74; AMD, 1985 MAR p. 1612, Eff. 11/1/85; TRANS, from DHES, 2001 MAR p. 398; AMD, 2008 MAR p. 44, Eff. 1/18/08; AMD, 2014 MAR p. 1411, Eff. 7/1/14.

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