The newborn screening specimen/information form submitted to
the department pursuant to WAC
246-650-020
becomes the property of the state of Washington upon receipt by the Washington
state public health laboratory. The department shall protect the privacy of
newborns and their families and assure that all specimen/information forms
submitted for screening are protected from inappropriate use or access. A
newborn specimen/information form contains health care information that is
confidential under chapter 70.02 RCW.
(1) Storage: The newborn screening
specimen/information forms shall be kept at ambient temperature in secured
storage to preserve their confidentiality and prevent access by unauthorized
persons.
(2) Retention/destruction:
The newborn screening specimen/information form shall be retained until the
child is twenty-one years old in accordance with the requirements for hospitals
specified in
RCW
70.41.190. After this time the department
shall destroy the form.
EXCEPTION FOR PARENTAL REQUEST: Upon request of a parent or
guardian (or a patient who is over the age of eighteen years), the department
shall destroy the newborn screening specimen/information form only after all
required screening tests have been performed and if the patient's
screening/clinical status related to these tests is not in question.
(3) Access: Access to stored
newborn screening specimen/information forms must be restricted to department
employees and those contractors or others approved by the department as
necessary to meet specific program needs. Access is contingent upon compliance
with all applicable federal and state laws, regulations, and policies
safeguarding the privacy and confidentiality of medical information. The
department shall assure that those granted access understand the
confidentiality requirements and have a signed confidentiality agreement on
file.
(4) Release: Dried blood spot
samples and specimen information may only be released when required by state or
federal law or under the following conditions:
(a) A sample from a specimen and copies of
associated identifying information (patient information and testing results, if
requested) may be released to:
(i) A health
care provider at the request of the patient or his or her legal representative
after completing and signing a written request form approved by the department.
The release form must be provided to the director of newborn screening before
the request will be fulfilled.
(ii)
A researcher with the written, informed consent of the patient or the patient's
legal representative as part of a research project that has been reviewed and
approved by the Washington state institutional review board and the secretary
or designee of the department.
(iii) A named person in a legally executed
subpoena following review and approval of the state attorney general.
(iv) A person to whom release is mandated by
order of a court of competent jurisdiction.
(b) Anonymous samples may be released if the
department determines that the intended use has significant potential health
benefit and that each of the following criteria have been met:
(i) The investigation design is adequate to
assure anonymity will be preserved.
(ii) All newborn screening tests have been
completed and the status of the infant is resolved.
(iii) At least one fully adequate spot will
remain after the anonymous sample has been taken.
(iv) Sufficient resources (personnel) are
available for extracting the samples.
(v) The Washington state institutional review
board has reviewed and approved the investigation. This requirement may be
waived by the department for a very small (i.e., less than 100 sample) pilot
study where the intent is to evaluate a testing tool, as opposed to an
evaluation where the intent is to measure some characteristic of a
population.
(5)
Notification: The department shall notify parents or guardians of the specimen
storage, retention/destruction and access requirements through the department's
newborn screening informational pamphlet.
Notes
Wash. Admin. Code §
246-650-050
Amended by
WSR
19-20-025, Filed 9/23/2019, effective
10/24/2019
Statutory Authority:
Chapters
70.83,
43.20 RCW. 03-24-026, §
246-650-050, filed 11/24/03, effective
12/25/03.
