Nebraska Administrative Code › Topic - HEALTH AND HUMAN SERVICES SYSTEM › Title 181 - SPECIAL HEALTH PROGRAMS › Chapter 2 - SCREENING OF INFANTS FOR INHERITED AND CONGENITAL INFANT OR CHILDHOOD-ON-SET DISEASES › Section 181-2-007 - TESTING LABORATORY DUTIES

Current through June 17, 2024
007.01
GENERAL RULES.
007.01(A)
ELECTRONIC
  TRANSMISSION.
The testing laboratory must report all of the
  information on the collection and reporting form electronically, at its own
  expense, to the Nebraska Newborn Screening Program (NNSP) in electronic format
  that provides complete demographic and test results records for each infant and
  that provides the reporting functions as specified by the Department in 181 NAC
  2-007.02(A) and in
  contract. The testing laboratory must provide, at its own expense, the
  necessary software and hardware.
007.01(B)
TEST
  PERFORMANCE.
The testing laboratory must perform all tests
  required in the contract between the Department and the laboratory at least six
  days a week.
007.01(C)
CONTACT PERSON.
The testing laboratory must keep the
  Nebraska Newborn Screening Program (NNSP) informed of the contact person
  responsible for newborn screening.
007.01(D)
SCREENING
  TESTS.
Except as provided in the disaster preparedness plan as
  required in the contract, the screening tests must be completed only by the
  laboratory designated by contract with the Department beginning with the
  effective date of the contract.
007.01(E)
CONFIRMATORY
  TESTS.
Confirmatory tests may be done by any laboratory including
  the laboratory designated by the Department as long as it is certified under
  the Clinical Laboratory Improvement Amendments (CLIA) and meets standards as
  set forth at 181 NAC
  2-007.01(E), items
  (i) and (ii). The contracted newborn screening laboratory will append to the
  laboratory report for all presumptive positive screening results, disorder
  specific recommendations for immediate testing and clinical follow-up, as
  approved by the Department.
(i) Confirmatory
  testing laboratories must be Clinical Laboratory Improvement Amendments (CLIA)
  certified, and maintain data to support validation of the assays and normal
  reference ranges for neonates and infants for whom confirmatory testing is
  provided.
(ii) Confirmatory testing
  laboratories must provide at a minimum written or electronic laboratory reports
  back to the specimen submitter that include:
(1) Name of test.
(2) Validated age-appropriate normal
  reference ranges for the analytes tested when confirming for endocrinopathies
  (Congenital Adrenal Hyperplasia and Congenital Primary Hypothyroidism) and
  hemoglobinopathies.
(3) Test method
  and relative amounts of hemoglobins when confirming for
  hemoglobinopathies.
(4)
  Identification of ratios when hemoglobins A and S are present.
(5) Test results in quantitative values
  (except hemoglobins above) and units of measure consistent with units of
  measure in the normal reference ranges or values.
(6) Interpretation of results appropriate to
  the age of the newborn or infant.
(7) Name and address where testing was
  completed.
(8) Name and phone
  number of person providing the interpretation.
(9) Written acknowledgement of conditions
  that may interfere with the appropriate interpretation of results.