6 CCR 1009-9
Colorado has a comprehensive public health AIDS/HIV control law: Colorado Revised Statutes Title 25, Article 4, Sections 1401 et seq. These regulations are intended to provide detail and clarification for selected parts of the above cited statute. The statute covers subject matters not included in these regulations.
C.R.S. 25-4-1405.5 (2) (a) (I) requires the Colorado Department of Public Health and Environment (CDPHE) to conduct an anonymous counseling and testing program for persons considered to be at high risk for infection with HIV. The provision of confidential counseling and testing for HIV is the preferred screening service for detection of HIV infection. Local boards of health who provide HIV counseling and testing through a contractual agreement with the CDPHE must consider the need for an anonymous HIV testing option in their jurisdiction. The consideration of this option must provide an opportunity for public comment in a public forum at a minimum of every two years. Other mechanisms for input into the need for an anonymous testing option in that jurisdiction must be available in addition to the public forum, including anonymous testimony in writing or through an organization. Local Boards of Health must document the following: notification of interested parties and the public, time allowed between notification and the public forum, accessibility in both location and time of the public forum, and the response to public comment in the lecision process. Local boards of health electing to provide confidential HIV testing with an anonymous option must do so in conjunction with counseling and testing sites (CTS); i.e., CDPHE designated sites which screen individuals for HIV infection without providing on-going health care. This will be done through a contractual agreement with the CDPHE. Local boards of health may elect, at the time of contract renewal, to provide confidential testing with an anonymous option. Per C.R.S. 25-4-1405.5 (2) (a) (II), Regulations 6–8 are the performance standards for confidential and anonymous HIV CTS and the CDPHE staff.
Regulation 1. Reporting By Physicians, Health Care Providers, Hospitals, And Others Diagnosed cases of AIDS, HIV-related illness, and HIV infection, regardless of whether confirmed by laboratory tests, shall be reported to the state or local health department or health agency within 7 days of diagnosis by physicians, health care providers, hospitals, or any other person providing treatment to a person with HIV infection. When hospitals and laboratories transmit disease reports electronically using systems and protocols developed by the department that ensure protection of confidentiality, such reporting is acceptable and is considered good faith reporting. All cases are to be reported with the patient's name, date of birth, sex, address (including city and county), name and address of the reporting physician or agency; and such other information as is needed to locate the patient for follow-up. For cases reported from a public anonymous testing site as provided by C.R.S. 25-4-1405.5, the patient's name and address and the name and address of the reporting physician are not required.
Reports on hospitalized patients may be made part of a report by the hospital as a whole. Research activities of persons performing clinical research on persons with AIDS, HIV-related illness, or HIV infection whose research activity:
1. involves the study of HIV treatment or vaccine effectiveness or is basic biomedical research into the cellular mechanisms causing HIV infection or HIV-related disease;
2. meets the research exemption criteria of C.R.S. 25-4-1402.5(3); and 3. has been approved by the Board of Health pursuant to C.R.S. 25-4-1402.5(2) shall be exempt from meeting the reporting requirements for AIDS, HIV-related illness, and HIV infection. Regulation 2. Reporting by Laboratories Laboratories shall report every test result that is diagnostic of or highly correlated with or indicates hiv infection. The report shall include the name, date of birth, sex and address of the individual from whom the specimen was submitted. Such test results shall be reported by all in-state laboratories and by out-of- state laboratories that maintain an office or collection facility in Colorado or arrange for collection of specimens in Colorado. Results must be reported by the laboratory which performs the test, but an in- state laboratory which sends specimens to an out-of-state referral laboratory is also responsible for reporting the results. The laboratory shall also report the name and address of the attending physician and any other person or agency referring such specimen for testing. When associated with other clinical or laboratory evidence of HIV infection, the Board of Health defines a CD4 test result of either CD4 count <500 mm3 or CD4% <29% as a primary immunologic measure indicating severe HIV infection and, when the count is <200 mm3, as defining AIDS. Laboratories shall report CD4 counts <500 mm3 OR CD4% <29%. The Department shall destroy personal identifying information on all persons with CD4 results in the reportable range if investigation subsequent to the report finds no evidence of HIV infection. Laboratories may fulfill the requirement to report CD4 counts <500 mm3 or CD4% <29% by allowing authorized personnel of the Department of Public Health and Environment access to such records.
Laboratories shall follow the same procedures for reporting as are required of other reporting sources in Regulation 1.
Report of test results by a laboratory does not relieve the attending physician of his/her obligation to report the case or diagnosis, nor does report by the physician relieve the laboratory of its obligation. Regulation 3. Information Sharing Information concerning cases of AIDS, HIV-related illness, or HIV infection shall be shared between the appropriate local health department or health agency and the state health department, as provided by C.R.S. 25-4-1404 (1)(B), and in a timely manner, usually within the timeframe for reporting in Regulation 1.
These requirements shall not apply if the state and local health agencies mutually agree not to share information on reported cases.
Regulation 4. Confidentiality All public health reports and records held by the state or local health department in compliance with these regulations shall be confidential information subject to C.R.S. 25-4-1404. The public health reports and records referred to in C.R.S. 25-4-1404 shall include, but not be limited to, the forms and records designated by the CDPHE for institutions and agencies which screen individuals for HIV infection without providing ongoing health care, such as a public HIV counseling and testing site. Reasonable efforts shall be made by the department to consult with the attending physician or medical facility caring for the patient prior to any further follow-up by state or local health departments or health agencies.
Regulation 5. Investigations To Confirm The Diagnosis And Source Of HIV Infection And To Prevent HIV Transmission It is the duty of state and local health officers to conduct investigations to confirm the diagnosis and sources of HIV infection and to prevent transmission of HIV. Such investigations shall be considered official duties of the health department or health agency. Such investigations may include, but are not limited to:
1. review of pertinent, relevant medical records by authorized personnel if necessary to confirm the diagnosis, to investigate possible sources of infection, to determine objects and materials potentially contaminated with HIV and persons potentially exposed to HIV. Such review of records may occur without patient consent and shall be conducted at reasonable times and with such notice as is reasonable under the circumstances;
2. performing follow-up interview(s) with the case or persons knowledgeable about the case to collect pertinent and relevant information about the sources of HIV infection, materials and objects potentially contaminated with HIV, and persons who may have been exposed to HIV. Regulation 6. Objective Standards A. Training 1. All persons providing HIV pre and posttest prevention and risk-reduction counseling at a CTS will have completed the HIV Serologic Test Counseling course or an equivalent of not less than 16 hours of training, approved by the CDPHE STD/AIDS Program.
2. All persons providing HIV pre and posttest prevention and risk-reduction counseling at a CTS will have a minimum of 8 hours of relevant HIV/STD or allied health services continuing education annually, approved by the CDPHE STD/AIDS Program.
3. All persons performing partner notification interviews will have completed courses concerning introduction to sexually transmitted disease interviewing and partner notification, as specified by the CDPHE.
B. Notification of Results 1. Of all HIV tests performed at a CTS, 90% of those persons testing HIV positive will receive results and posttest risk-reduction counseling.
2. Of all HIV tests performed at a CTS, 80% of those persons testing HIV negative will receive results and posttest prevention and risk-reduction counseling.
C. Partner Notification If CDPHE staff provide partner notification for a CTS, then the following standards do not apply to the CTS.
1. Of the 90% of HIV positive individuals receiving results and posttest counseling, 100% will be assigned for partner notification interview. A minimum of 75% of those assigned for a partner notification interview will receive an interview. Agencies providing partner notification services (CDPHE and local health departments) will have a partner index (defined as the number of unsafe partners identified for whom identifying information was sufficient to initiate notification, divided by the number of interviewed HIV positive persons with unsafe behavior in the past year) of 0.8. Effective January 1, 1995, the acceptable partner index will be 1.0. Documentation of this activity will be provided to the CDPHE through use of a CDPHE specified form. A contact is defined as a person named by an infected person as having been an unsafe sex partner/needle share partner of that infected person. If sufficient locating information (name, age, sex, phone number, recent address, work address) is obtained to conduct an investigation, such a contact is defined as an initiated contact.
2. Of all in-state initiated contacts, 60% must be located and offered HIV prevention and risk-reduction counseling and/or testing as documented by the results of the investigation on the CDPHE specified form. Documentation of investigation outcomes will include disposition codes as specified by the CDPHE, dates and location of counseling, and dates and location of testing (if done).
Regulation 7. Operational Standards A. Counseling 1. All counselors at a CTS performing HIV pretest prevention and risk-reduction counseling will: a) conduct a risk assessment, b) discuss and develop a risk-reduction plan, i.e., identify with the client specific behaviors that can realistically be changed to reduce risk, c) fully and legibly complete for each person tested the HIV 1 Serology lab slip.
2. All counselors at a CTS performing HIV posttest prevention and risk-reduction counseling will: a) inform clients in person of test results, b) explain the significance of both positive and negative test results, c) discuss and/or modify the risk-reduction plan, d) refer clients who test positive for follow-up medical and counseling services.
B. Consent Form 1. A consent form specified by the CDPHE or an approved equivalent must be used at all CTS.
C. Testing Parameters 1. CTS will not provide anonymous testing to any person 12 years of age or younger.
2. If a counselor judges that a client is unable to understand either counseling or the testing process, e.g., because the client is under the influence of drugs or alcohol, the counselor may defer testing.
D. Written Results 1. CTS may only provide written results to persons testing confidentially. To receive written results, the CTS must be presented with photo identification from the person requesting written results at the time of posttest.
2. Contracting agencies may not give written results to any person testing anonymously.
E. Confidentiality and Record Maintenance 1. Contracting agencies must have and adhere to an HIV record retention policy. Any record retention policy must be adopted by the local board of health with the opportunity for public comment and input through an open public forum conducted at least every two years. Other mechanisms for input into the record retention policy must be available in addition to the public forum, including anonymous testimony in writing or through an organization. Any policy must address the following areas:
2. Per C.R.S. 25-4-1404.5 (2) (a) (II), a person may provide personal identifying information after counseling, if the person volunteers to do so. Contracting agencies must document this information when volunteered, and provide this information to the CDPHE on the posttest reimbursement form submitted to the CDPHE within 30 days of the date the blood specimen was collected.
Regulation 8. Evaluation Standards and Penalties A. Each CTS's compliance with these standards will be evaluated by the following:
B. Failure of a CTS to comply with and meet these standards may result in one or more of the following action(s):