(Consent Requirements for HIV Testing)
(Credit: Ms Marina Pantchenko kindly performed a search on the legal aspects of this challenging issues in medicine)
California Health and Safety Code
Section 120990
(a)
Prior to ordering a test that identifies infection of a patient with HIV, a medical care provider
shall inform the patient that the test is planned, provide information about the test, inform the
patient that there are numerous treatment options available for a patient who tests positive
for HIV and that a person who tests negative for HIV should continue to be routinely tested,
and advise the patient that he or she has the right to decline the test. If a patient declines the
test, the medical care provider shall note that fact in the patient's medical file.
(b)
Subdivision (a) does not apply when a person independently requests an HIV test from a
medical care provider.
(c)
Except as provided in subdivision (a), a person shall not administer a test for HIV infection
unless the person being tested or his or her parent, guardian, conservator, or other person
specified in Section 121020 has provided informed consent for the performance of the test.
Informed consent may be provided orally or in writing, but the person administering the test
shall maintain documentation of consent, whether obtained orally or in writing, in the client's
medical record. This consent requirement does not apply to a test performed at an
alternative site pursuant to Section 120890 or 120895. This section does not authorize a
person to administer a test for HIV unless that person is otherwise lawfully permitted to
administer an HIV test.
(d)
Subdivision (c) shall not apply when a person independently requests an HIV test from an
HIV counseling and testing site that employs a trained HIV counselor, pursuant to Section
120917, provided that the person is provided with information required pursuant to
subdivision (a) and his or her independent request for an HIV test is documented by the
person administering the test.
(e)
Nothing in this section shall preclude a medical examiner or other physician from ordering or
performing a test to detect HIV on a cadaver when an autopsy is performed or body parts are
donated pursuant to the Uniform Anatomical Gift Act (Chapter 3.5 (commencing with Section
7150) of Part 1 of Division 7).
(f)
(1)
The requirements of subdivision (c) do not apply when blood is tested as part of a scientific
investigation conducted either by a medical researcher operating under the approval of an
institutional review board or by the department, in accordance with a protocol for unlinked
testing.
(2)
For purposes of this subdivision, "unlinked testing" means blood samples that are obtained
anonymously, or that have the name or identifying information of the individual who provided
the sample removed in a manner that prevents the test results from ever being linked to the
particular individual who participated in the research or study.
(g)
Nothing in this section permits a person to unlawfully disclose an individual's HIV status, or
to otherwise violate provisions of Section 54 of the Civil Code, the Americans With
Disabilities Act of 1990 (Public Law 101-336), or the California Fair Employment and
Housing Act (Part 2.8 (commencing with Section 12900) of Division 3 of Title 2 of the
Government Code), which prohibit discrimination against individuals who are living with HIV,
who test positive for HIV, or who are presumed to be HIV-positive.
(h)
After the results of a test performed pursuant to this section have been received, the medical
care provider or the person who administers the test shall ensure that the patient receives
timely information and counseling, as appropriate, to explain the results and the implications
for the patient's health. If the patient tests positive for HIV infection, the medical provider or
the person who administers the test shall inform the patient that there are numerous
treatment options available and identify followup testing and care that may be recommended,
including contact information for medical and psychological services. If the patient tests
negative for HIV infection and is known to be at high risk for HIV infection, the medical
provider or the person who administers the test shall advise the patient of the need for
periodic retesting, explain the limitations of current testing technology and the current
window period for verification of results, and may offer prevention counseling or a referral to
prevention counseling.
(i)
This section shall not apply to a clinical laboratory.
(When HIV testing is permitted without consent)
California Health and Safety Code
Section 120262
Notwithstanding Chapter 7 (commencing with Section 120975) or any other law, the blood or
other tissue or material of a source patient may be tested, and an exposed individual may be
informed whether the patient has tested positive or negative for a communicable disease if
the exposed individual and the health care facility, if any, have substantially complied with
the then applicable guidelines of the Division of Occupational Safety and Health and the
State Department of Health Services and if the following procedure is followed:
(a)
(1)
If a person becomes an exposed individual by experiencing an exposure to the blood or
other potentially infectious material of a patient during the course of rendering health care-
related services or occupational services, the exposed individual may request an evaluation
of the exposure by a physician to determine if it is a significant exposure, as defined in
subdivision (h) of Section 120261. A physician or other exposed individual shall not certify
his or her own significant exposure. However, an employing physician may certify the
exposure of one of his or her employees. Requests for certification shall be made in writing
within 72 hours of the exposure.
(2)
A written certification by a physician of the significance of the exposure shall be obtained
within 72 hours of the request. The certification shall include the nature and extent of the
exposure.
(b)
(1)
The exposed individual shall be counseled regarding the likelihood of transmission, the
limitations of the testing performed, the need for followup testing, and the procedures that the
exposed individual must follow regardless of whether the source patient has tested positive
or negative for a communicable disease. The exposed individual may be tested in
accordance with the then applicable guidelines or standards of the Division of Occupational
Safety and Health. The result of this test shall be confirmed as negative before available
blood or other patient samples of the source patient may be tested for evidence of infection
to a communicable disease, without the consent of the source patient pursuant to subdivision
(d).
(2)
Within 72 hours of certifying the exposure as significant, the certifying physician shall provide
written certification to an attending physician of the source patient that a significant exposure
to an exposed individual has occurred, and shall request information on whether the source
patient has tested positive or negative for a communicable disease, and the availability of
blood or other patient samples. An attending physician shall respond to the request for
information within three working days.
(c)
If test results of the source patient are already known to be positive for a communicable
disease then, except as provided in subdivisions (b) and (c) ofSection 121010, when the
exposed individual is a health care provider or an employee or agent of the health care
provider of the source patient, an attending physician and surgeon of the source patient shall
attempt to obtain the consent of the source patient to disclose to the exposed individual the
testing results of the source patient regarding communicable diseases. If the source patient
cannot be contacted or refuses to consent to the disclosure, then the exposed individual may
be informed of the test results regarding communicable diseases of the source patient by an
attending physician of the source patient as soon as possible after the exposure has been
certified as significant, notwithstandingSection 120980 or any other law.
(d)
If the communicable disease status of the source patient is unknown to the certifying
physician or an attending physician, if blood or other patient samples are available, and if the
exposed individual has tested negative on a baseline test for communicable diseases, the
source patient shall be given the opportunity to give informed consent to a test for
communicable diseases in accordance with the following:
(1)
Within 72 hours after receiving a written certification of significant exposure, an attending
physician of the source patient shall do all of the following:
(A)
Make a good faith effort to notify the source patient or the authorized legal representative of
the source patient about the significant exposure. A good faith effort to notify includes, but is
not limited to, a documented attempt to locate the source patient by telephone or by first-
class mail with a certificate of mailing. An attempt to locate the source patient and the results
of that attempt shall be documented in the medical record of the source patient. An inability
to contact the source patient, or legal representative of the source patient, after a good faith
effort to do so as provided in this subdivision, shall constitute a refusal of consent pursuant to
paragraph (2). An inability of the source patient to provide informed consent shall constitute a
refusal of consent pursuant to paragraph (2), provided all of the following conditions are met:
(i)
The source patient has no authorized legal representative.
(ii)
The source patient is incapable of giving consent.
(iii)
In the opinion of the attending physician, it is likely that the source patient will be unable to
grant informed consent within the 72-hour period during which the physician is required to
respond pursuant to paragraph (1).
(B)
Attempt to obtain the voluntary informed consent of the source patient or the authorized legal
representative of the source patient to perform a test for a communicable disease, on the
source patient or on any available blood or patient sample of the source patient. The
voluntary informed consent shall be in writing. The source patient shall have the option not to
be informed of the test result. An exposed individual shall be prohibited from attempting to
obtain directly informed consent for testing for communicable diseases from the source
patient.
(C)
Provide the source patient with medically appropriate pretest counseling and refer the source
patient to appropriate posttest counseling and followup, if necessary. The source patient
shall be offered medically appropriate counseling whether or not he or she consents to
testing.
(2)
If the source patient or the authorized legal representative of the source patient refuses to
consent to test for a communicable disease after a documented effort has been made to
obtain consent, any available blood or patient sample of the source patient may be tested.
The source patient or authorized legal representative of the source patient shall be informed
that an available blood sample or other tissue or material will be tested despite his or her
refusal, and that the exposed individual shall be informed of the test results regarding
communicable diseases.
(3)
If the informed consent of the source patient cannot be obtained because the source patient
is deceased, consent to perform a test for a communicable disease on any blood or patient
sample of the source patient legally obtained in the course of providing health care services
at the time of the exposure event shall be deemed granted.
(4)
A source patient or the authorized legal representative of a source patient shall be advised
that he or she shall be informed of the results of the test for communicable diseases only if
he or she wishes to be so informed. If a patient refuses to provide informed consent to
testing for communicable diseases and refuses to learn the results of the testing, he or she
shall sign a form documenting this refusal. The source patient's refusal to sign this form shall
be construed to be a refusal to be informed of the test results regarding communicable
diseases. Test results for communicable diseases shall only be placed in the medical record
when the patient has agreed in writing to be informed of the results.
(5)
Notwithstanding any other law, if the source patient or authorized legal representative of a
source patient refuses to be informed of the results of the test, the test results regarding
communicable diseases of that source patient shall only be provided to the exposed
individual in accordance with the then applicable regulations established by the Division of
Occupational Safety and Health.
(6)
The source patient's identity shall be encoded on the communicable disease test result
record.
(e)
If an exposed individual is informed of the status of a source patient with regard to a
communicable disease pursuant to this section, the exposed individual shall be informed that
he or she is subject to existing confidentiality protections for any identifying information about
the communicable disease test results, and that medical information regarding the
communicable disease status of the source patient shall be kept confidential and may not be
further disclosed, except as otherwise authorized by law. The exposed individual shall be
informed of the penalties for which he or she would be personally liable for violation
of Section 120980.
(f)
The costs for the test and counseling for communicable diseases of the exposed individual,
or the source patient, or both, shall be borne by the employer of the exposed individual, if
any. An employer who directs and controls the exposed individual shall provide the
postexposure evaluation and followup required by the Division of Occupational Safety and
Health as well as the testing and counseling for source patients required under this chapter.
If an exposed individual is a volunteer or a student, then the health care provider or first
responder that assigned a task to the volunteer or student may pay for the costs of testing
and counseling as if that volunteer or student were an employee. If an exposed individual,
who is not an employee of a health facility or of another health care provider, chooses to
obtain postexposure evaluation or followup counseling, or both, or treatment, he or she shall
be financially responsible for the costs thereof and shall be responsible for the costs of the
testing and counseling for the source patient.
(g)
This section does not authorize the disclosure of the source patient's identity.
(h)
This section does not authorize a health care provider to draw blood or other body fluids
except as otherwise authorized by law.
(i)
The provisions of this section are cumulative only and shall not preclude testing of source
patients for a communicable disease, as authorized by any other law.
(j)
Except as otherwise provided under this section, all confidentiality requirements regarding
medical records that are provided for under existing law apply to this section.