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Washington Administrative Code (Last Updated: November 23, 2016) |
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Title 246. Health, Department of |
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Chapter 246-650. Newborn screening. |
Section 246-650-050. Privacy and security of screening specimen/information forms.
Latest version.
- The 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.(1) Storage: The 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 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 form will be destroyed.EXCEPTION FOR PARENTAL REQUEST: Upon request of a parent or guardian (or a patient who is over the age of eighteen years), the department will destroy the 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 specimen/information forms shall 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 information (patient information and testing results, if requested) may be released to:(i) A health care provider at the request of the patient or their 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 their patient's legal representative as part of a research project that has been reviewed and approved by the DOH/DSHS human subjects research review board and the secretary or designee of the department of health.(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 DOH/DSHS human subjects research 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 of the specimen storage, retention/destruction and access requirements through the department's newborn screening informational pamphlet.
Rules
246-650-020,