Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 143 - TESTING OF NEWBORN INFANTS FOR METABOLIC AND OTHER DISEASES › Section 11-143-9 - Laboratory responsibilities

Current through June, 2024
(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 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;
(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.