Washington Administrative Code › Title 246 - Health, Department of › LABORATORY › Chapter 246-650 - Newborn screening › Section 246-650-050 - Privacy and security of newborn screening specimen/information forms

Current through Register Vol. 24-14, July 15, 2024
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.