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
Universal Citation: HI Admin Rules 11-143-9
Current through February, 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.
(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.
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