Communicable Disease Testing Guidance
Guidance for Investigators Testing Subjects for Communicable Diseases
Version Date: June 16, 2011
This guidance is designed to assist investigators with required consent form language and required reporting to the state epidemiologist (for HIV/AIDS reports) or the local health department (for all other reports) when testing subjects for communicable diseases. If identifiable specimens are provided to the University of Wisconsin Hospital and Clinics (UWHC) laboratory or the Wisconsin State Laboratory of Hygiene (WSLH), the UWHC laboratory or WSLH will make required reports to the state epidemiologist or local health department. If only coded specimens are provided to the UWHC laboratory or WSLH, the study team is responsible for making all required reports. Additionally, when testing for HIV, if a UWHC consent form is not used, the study consent form must comport with Wisconsin law as discussed below.
Testing for Communicable Diseases (including HIV)
If a subject tests positive for any of the communicable diseases, a report must be made to the appropriate local health department or state epidemiologist. A list of local health departments may be accessed through this link.
Who Must Report? Each licensed health care provider (includes licensed nurses, physicians, physical therapists, podiatrists, athletic trainers, and occupational therapists), each laboratory that is CLIA certified, or the person in charge of infection control program at each healthcare facility shall ensure that reports are made to the local health department or to the state epidemiologist. If identifiable specimens are provided to the UWHC laboratory or the WSLH, the UWHC laboratory or WSLH will make the required reports. (Note that identifiable specimens are provided to the UWHC laboratory, subjects must be informed that test results will be put in their UWHC medical record.) If only coded specimens are provided to the UWHC laboratory or WSLH, the study team is responsible for making all required reports.
What Information Must be Included? Each report must include the name of the person reporting, the name of the attending physician if any, the diagnosed or suspected disease, the name of the affected individual, that individual's address and telephone number, age or date of birth, race and ethnicity, sex, county of residence, date of onset of disease, name of parent or guardian if a minor, and other information requested by the local health officer.
How are Reports Made? A diagnosis of HIV or AIDS must be reported to the state epidemiologist on an AIDS Case Report Form (DPH 4264) or a Wisconsin Human Immunodeficiency Virus (HIV) Infection Confidential Case Report Form (DPH 4338). Forms DPH 4264 and DPH 4338 can be ordered from the Department of Health and Family Services (DHFS) on the order form. All other reports of communicable diseases can be oral or written. If written, the report must be made on the individual case report form provided by DHFS. Individual case report forms can be ordered through DHFS.
When Must Reports be Made? Category I diseases, which are more urgent public health importance, must be reported immediately. Diseases in Category II or Category III can be reported within 72 hours.
Maintaining Records of Tests and Reports. Under Wisconsin Law, records of HIV test results must be maintained by the reporting individual or entity. To protect subjects' privacy and reduce the chance of unintended disclosures, many research protocols dictate that all positive test results for communicable diseases will be destroyed and subjects deemed ineligible for study participation. The Division of Public Health with DHFS has concurred with Wisconsin Law. Additionally, for purposes of verifying compliance with Wisconsin reporting laws, the study team should maintain records of any report made to local health departments or the state epidemiologist, but may de-identify such forms to protect subjects' privacy.
HIV Testing and Consent
If identifiable specimens will be sent to the UWHC laboratory for testing subjects must be informed that positive results will be placed in their medical record.
Study teams may create a separate consent for HIV testing, or may include required language within the study informed consent document. Under Wisconsin law, the informed consent document for HIV testing must contain the following information: the name of the potential test subject; a statement that results may be disclosed as provided by Wisconsin law; and a signature of the test subject or his/her health care power of attorney. Positive test results must be provided to the subject.
As noted, Wisconsin law requires that subjects be informed that their test results may be disclosed without their consent under nineteen difference circumstances. Those nineteen circumstances may be listed in the consent document, or the consent document may state as follows:
"Your HIV test results may be disclosed without your consent only as provided by Wisconsin law. A listing of those circumstances in which your HIV test results maybe disclosed is available upon request".Those nineteen circumstances (chapter 252.15) must be provided to subjects at their request.
The diseases and conditions listed below are considered to have great public health impact, and any confirmed or suspected cases must be reported promptly.
Requirements for the timing of reporting once the disease or condition is recognized or suspected varies with the particular disease. The specific reporting requirements are listed in the Chapter DHS 145, Control of Communicable Diseases.
Questions concerning this information may be directed to the Bureau of Communicable Diseases by calling 608-267-9003.
The preceding diseases are of urgent public health importance and shall be reported IMMEDIATELY to the patient's local health officer upon identification of a case or suspected case. In addition to the immediate report, complete and mail an Acute and Communicable Diseases Case Report (DPH 4151) to the address on the form within 24 hours. Public health intervention is expected as indicated.
The preceding diseases shall be reported to the local health officer on an Acute and Communicable Disease Report (DPH 4151) or by other means within 72 hours of the identification of a case or suspected case.
The preceding diseases shall be reported to the state epidemiologist on an AIDS Case Report (DPH 4264) or a Wisconsin Human Immunodeficiency Virus (HIV) Infection Confidential Case Report (DPH 4338) or by other means without 72 hours after identification of a case or suspected case.
Nineteen circumstances (chapter 252.15)