HAR §11-143-9. Laboratory responsibilities

(a) A laboratory wishing to offer the newborn screening tests shall submit a proposal for provision of newborn screening laboratory services, as specified by the department. (b) The designated laboratory shall: (1) Provide laboratory analysis for the initial newborn screening tests, for the repeat newborn screening tests, and confirmatory tests on positive newborn screening results; (2) Maintain a system of linking all test results with the appropriate newborn; (3) Provide specimen collection forms and parent information brochures to hospitals, laboratories, birth attendants, and the department; (4) Provide practitioner's manuals to the department; (5) Implement and follow procedures for keeping all specimens received under adequate storage conditions to allow for retesting for at least one year; (6) Implement and follow record keeping procedures which include: (A) Procedures for the logging of received specimens; (B) Procedures for tracking repeat testing for previous unacceptable specimens and positive newborn screening tests; (C) Procedures for the reporting of all test results to the newborn's physician, hospital, and the department; (D) Procedures for the reporting of positive newborn screening tests and unacceptable specimens to the newborn's physician and the department as soon as 143-11 3553 §11-143-9 possible but not later than seven working days after receipt of the specimen; (7) Implement and follow a schedule of reporting to the department: (A) Daily reports that shall include as a minimum: (i) Positive newborn screening test results case report, including newborn's name, parents' name, address, phone number, and name of primary care provider; (ii) Unacceptable specimen case report, including newborn's name, parents' name, address, phone number, and name of primary care provider; (B) Monthly and annual reports that shall include as a minimum: (i) Collection status: Number of acceptable and unacceptable specimens by source; (ii) Unduplicated number of infants tested by source; (iii) Number of positive and negative newborn screening tests by disorder; (iv) Number of repeat tests for previous specimens collected for newborns less than twenty-four hours of age; (8) Maintain an internal quality assurance program; (9) Participate in an external proficiency testing and quality assurance program approved by the department; (10) Implement and follow procedures for specimen handling and laboratory testing during emergencies or other situations when the laboratory is shut down for more than three working days; 143-12 3 5 5 3 §11-143-12 (11) Provide an ongoing educational program to maintain and upgrade knowledge and skills of laboratory staff; and (12) Arrange for designated specialists in metabolic, hemoglobin, pulmonary, endocrine, and immunodeficiency disorders to be available for consultation regarding interpretation of test results, and guidelines for care, treatment, and follow-up of infants with positive newborn screening test results. (c) Only the laboratory that has been selected in writing by the department as the designated laboratory shall be allowed to offer newborn screening testing. [Eff 1/24/87; am and comp 6/19/97; am and comp 11/20/03; am and comp 1/22/09; am and comp AUG 11 2024 ] (Auth: HRS §321-291) (Imp: HRS §321-291) ###