HIV testing (in California)

Background

• Consent requirements for HIV testing from state to state.
• In California, California Health and Safety Code Section 120990 speaks to this issue.

Requirements Before Ordering The Test

Prior to ordering a test that identifies infection of a patient with HIV, a medical care provider

• MD shall
  • inform the patient he/she will be tested for HIV.
  • provide information about the test

inform that if positive, there are numerous treatment options available

• • inform that if negative, the a patient should continue to be routinely tested,

advise the patient that he/she has the right to decline the test.

• • document whether the informed consent was written or verbal
  • provide the results to the patient in timely manner with and counseling and contact for medical/psychological follow up

Difficult Situations

• Occupational Exposure
  • The exposed has to seek evaluation by a physician (not him/herself) for evaluation to determine if "significant exposure." **Significant exposure "means direct contact with blood or other potentially infectious materials of a patient in a manner that, according to the then applicable guidelines of the Division of Occupational Safety and Health, is capable of transmitting a

communicable disease. (subdivision (h) of Section 120261.)

• • The treating physician has to certify by documenting that a significant exposure occurred.
  • A test for HIV on the exposed has to be done and confirmed before a test on the source patient can be done without consent. The attending physician for the exposed can then test the patient without his consent.
  • This test can be performed on any available blood or other tissue sample.
  • If the source patient died, the source patient's blood can be obtained and tested regardless of any consenting.
  • If the patient is living and there is no blood sample and the patient refuses to allow for a blood sample to be obtained, it appears that this is not permitted except as otherwise authorized by law.

• • The source patient has the option not to be informed of the results. If he/she does not want to be informed of the results, the results cannot be documented in his/her chart.

• • The exposed patient cannot directly attempt to obtain informed consent from the source patient.
  • Costs of the testing will be assumed by the employer of the exposed patient.

• A medical provider can order a HIV test on a cadaver, or when autospy will be performed, or when body parts may be donated (Section 7150)

External Links=

http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=120001-121000&file=120260-120263

References

California Health and Safety Code Section 120990

(Consent Requirements for HIV Testing)

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.