- What is the "window period"?
- Answer: It is the time period lasting up to six months following infection with HIV in which someone will test negative on a regular HIV antibody test even though they are infected. Tests which can properly diagnose HIV during this stage are available through Project Open Window.
- What is primary or acute HIV infection?
- Answer: It is the first stage of HIV disease in which 50-80% of newly infected people experience an illness that is similar to a severe case of 'the flu' or 'mono' (mononucleosis). It is often accompanied by a burst in viral replication and a drop in blood T-cell numbers. For more information visit the Project Open Window site.
- What is AIDS Surveillance?
- Answer: In Public Health, Surveillance has been defined as the ongoing, systematic collection, analysis, and interpretation of data (e.g., regarding agent/hazard, risk factor, exposure, health event) essential to the planning, implementation, and evaluation of public health practice, closely integrated with the timely dissemination of these data to those responsible for prevention and control. Simply stated, the role of surveillance is to 1.)systematically track the demographic trends in the spread of a disease, such as AIDS, within a population. 2.) Use statistical analysis tools to clearly define these trends, 3.)and use the analyzed results to aid Public Health officials in implementing effective prevention and control programs throughout the Public Health Community
- What is the law in California governing AIDS reporting?
- Answer: In 1983, California Administrative Code, Title 17, §2500 (a) was amended to include AIDS among the list of over 50 diseases and medical conditions which every health care provider is required to report to the local health officer. California Administrative Code, Title 17, §2500 (d) states that "disease notifications shall include, if known, the diagnosis, the name, address, telephone number, occupation, ethnic group, social security number, sex and date of birth of the patient, the date of onset, the date of diagnosis, the date of death when applicable and the name, address and telephone number of the person making the report." California Administrative Code, Title 17, §2512 allows the local health officer to investigate communicable diseases and sections 304 and 306 of the Public Health Services Act authorizes the use of the "AIDS Pediatric Confidential Case Report" and the "AIDS Adult Confidential Case Report".
- What is the law concerning confidentiality in AIDS reporting?
- Answer: California Health and Safety Code, §211.5 establishes the confidential nature of records, reports, and statements obtained by the health officer. "All records of interviews, written reports and statements procured by the state department or by any other person, agency or organization acting jointly with the state department, in connection with special morbidity and mortality studies, shall be confidential insofar as the identity of the individual patient is concerned and shall be used solely for the purpose of the study..." Such reporting "shall not subject any person, hospital, sanitarium, rest home, nursing home, or other organization furnishing such information to any action for damages." Additionally, §211.5 allows for "the publishing by the state department of statistical compilations relating to morbidity and mortality studies which do not identify individual cases and sources of information or religious affiliations."
All surveillance and seroepidemiology research studies undergo review and approval by one or more certified institutional review boards (IRB) prior to the start of the study. Procedures for maintaining the confidentiality of all study participants are critically reviewed by each IRB. Annual reapplication and approval is required, and any proposed protocol changes during the course of the study are also reviewed by the IRB.
At the national level, the HIV/AIDS Reporting System (HARS) database (housed at the Centers for Disease Control and Prevention (CDC) is protected by a Federal Assurance of Confidentiality (Sections 306 and 308(d) of the Public Health Service Act (42 USC 242k and 242m(d)), which prohibits disclosure of any information that could be used to directly or indirectly identify patients.
- Answer: California Health and Safety Code, §211.5 establishes the confidential nature of records, reports, and statements obtained by the health officer. "All records of interviews, written reports and statements procured by the state department or by any other person, agency or organization acting jointly with the state department, in connection with special morbidity and mortality studies, shall be confidential insofar as the identity of the individual patient is concerned and shall be used solely for the purpose of the study..." Such reporting "shall not subject any person, hospital, sanitarium, rest home, nursing home, or other organization furnishing such information to any action for damages." Additionally, §211.5 allows for "the publishing by the state department of statistical compilations relating to morbidity and mortality studies which do not identify individual cases and sources of information or religious affiliations."
- How will my confidentiality be protected?
- Answer: In order to comply with these laws and ensure patient confidentiality, the HIV Epidemiology Program has established comprehensive procedures to protect confidentiality and ensure data integrity. The objectives of these procedures are to:
- protect patient confidentiality by preventing unauthorized disclosure of information
- ensure the integrity of data by preventing unauthorized alteration
- prevent the loss of data through accidental or malicious acts, or equipment failures, and
- to prevent harm to HEP functions or image through unauthorized disclosures.
A. General procedures
- All new HEP employees receive training in confidentiality and security issues and are required to read and retain a copy of this document and sign a confidentiality agreement (see Attachment B).
- All employees are required to attend an annual review seminar covering confidentiality and security policies and procedures. These policies/procedures are reviewed annually by the AIDS Surveillance Coordinator, and revised as necessary. All HEP employees must sign the confidentiality agreement every twelve months. Access to the computer network is denied until an updated signature is obtained.
- All records are strictly confidential. Employee access to confidential records and databases which contain patient-specific identifiers is granted only to those employees who must have access to perform their assigned job duties.
- All materials containing patient identifying information shall be maintained in restricted access areas.
- All records containing patient identifiers are kept in bar-locked files at all times, unless they are in the direct possession of an employee during office hours or during necessary field work.
- Records containing patient identifiers are not left unattended at any time. All confidential documents in the direct possession of an employee must be placed in secured files when leaving their work space for any reason (temporary absence). All employees who work with confidential materials are required to secure these materials in bar-locked files at the end of each work day.
- Confidential materials are not to be stored in desks that are not equipped with bar-locks.
- Confidential study forms that are being processed outside of the HEP office should be maintained in secure areas and locked away during non-business hours. All procedures involving the handling of study forms are to be approved by the appropriate unit supervisor. Specific written protocols for tracking and handling study forms should be developed for each study.
- Keys to desks and cabinets shall not be kept in easily accessible places or unlocked desk drawers.
- Confidential papers are shredded horizontally using a commercial grade electronic paper shredder before they are discarded.
- Keys to all HEP suites are issued only to HEP staff. Each key is stamped "Do Not Duplicate" and the locks on all doors to the secured suite are re-keyed annually.
- HEP offices are located in a building that has a 24 hour security guard. No HEP office suites are located on the ground floor. Entry into the building during non-business hours is permitted only to individuals who present a personalized building pass and the names of all persons entering and exiting are maintained in a log.
B. Maintaining the security of AIDS registry files
- A limited number of HEP employees are authorized to add or alter AIDS case information contained in the AIDS registry database (HARS).
- The secured suite which houses all AIDS registry files is a "Restricted Access" area and "Restricted Access" signs are prominently displayed. Only HEP staff are allowed to enter the file room and field staff cubicle area. The reception area is designated for visitors. Other Department of Health Services (DHS) staff, maintenance and janitorial workers may be allowed to enter restricted access areas with the supervision and permission of a unit supervisor. During such times, the suite is never left unattended and confidential data are removed from view (e.g., clearing computer screens, placing confidential documents in bar-locked file drawers).
- The secured suite must be locked when left unattended. The last person leaving the secured suite at any time is responsible for locking all bar-locked file cabinets, windows, and doors before leaving.
- Confidential AIDS Case Report Forms are stored exclusively in the secured suite.
- Confidential AIDS Case Report Forms are duplicated only if the case has been previously reported in an out-of-county or out-of-state jurisdiction or if the case was diagnosed in Los Angeles County but did not reside in the county at the time of AIDS diagnosis. In such cases, personal identifying information is clipped from the duplicated case report form and mailed separately to prevent improper disclosure.
- Answer: In order to comply with these laws and ensure patient confidentiality, the HIV Epidemiology Program has established comprehensive procedures to protect confidentiality and ensure data integrity. The objectives of these procedures are to:
- How do I report a case?
- Answer: The HIV Epidemiology Program is the designated County of Los Angeles- Department of Health Services AIDS case report collection entity. Medical and health care professionals can report an AIDS case by contacting the HIV Epidemiology Program at the address or phone number below. We can provide the appropriate case report forms and answer any AIDS case reporting questions.
