Legislative History and Intent

In 1985, the State of California passed legislation (Section 199.22 of the Health and Safety Code) that prohibits the testing of individuals for HIV without their expressed written consent. The law exist to protect the privacy of individuals and to discourage discrimination against individuals with certain conditions. As written, the laws do not permit an individual to waive the requirement nor can they imply consent through any actions or statements. The requirement to obtain written consent prior to testing includes employers and thereby protects an employee against involuntary testing.

In 1995 the Health and Safety Code was restructured and the statutes regarding the testing of individuals for the presence of HIV, and the notification of results of those tests, were renumbered. Under the current, restructured Health and Safety Code, Sections 120975 through 121035 frame the conditions that must exist when testing individuals for HIV and notifying individuals of test results. Sections 120885 through 120895 note the exclusions to the conditions stipulated in Sections 120975 through 121035, based on the State"s development of Alternative Test Sites.

The law defines Alternative Test Sites as a free standing facility that provides anonymous HIV testing, where no other medical or diagnostic services are provided. In order to meet this requirement the individual being tested must be unknown to the tester and cannot provide any information that would reveal his or her identity. This includes information such as a name, address, telephone number, or social security number, or any other information that would make it possible for the testing facility to contact the individual being tested. Any facility that provides HIV testing to individuals who are known to them, can be contacted by the facility, or are identified in any way, cannot be considered Alternative Test Sites under the existing State law.

All facilities providing testing for individuals who are known to them are considered Confidential Test Sites. Any testing performed at a confidential HIV testing site requires the written consent of the individual being tested. The forms granting the permission to test said individuals for HIV must be kept on file for three years. Section 199.22 [later renumbered to 120975] states:

The only exclusion applicable to the Medical Examiner with regard to HIV testing is contained in subsection (b). The exclusion states:

HIV Testing by the Medical Examiner"s Office

Members of the Medical Examiner"s Office staff acknowledge that employees have been tested for the presence of HIV antibodies in their blood. Two employees contend that in July 1994, they were tested involuntarily for HIV and Hepatitis B. Additionally, as of July, 1994, employees being screened for HIV were not required to sign written consent forms, as required by California state law. The OSHA required Exposure Control Plan (see Section II: Universal Precautions) contains a prototype of a consent form to be signed by employees who wish to be tested for HIV.

Under state law, a facility can be designated as an "Alternative Test Site" which permits testing of living subjects anonymously and without written consent. The Director of the San Francisco AIDS Project states that the Medical Examiner"s Office is not considered an "Alternative Test Site" which is defined as an alternative to the "blood bank", and the only testing the Medical Examiner"s Office is authorized to conduct, without obtaining the required written consent, is the testing of decedents. This testing is to be done without providing the identity of the test subject and the results are to be used to determine the prevalence of AIDS in the community. Any other HIV testing conducted by the Medical Examiner"s Office must conform with the conditions set forth in the State Health and Safety Code, and court orders.

During the course of this management audit, the Budget Analyst staff was informed by the Chief Medical Examiner, the Administrative Coroner, and Medical Examiner"s Office staff that testing of employees has continued and are being submitted to the Department of Public Health for analysis under the regulations defined in the Health and Safety Code. The Chief Medical Examiner further states that he does submit specimen for analysis from living and deceased individuals on the same form and that he has never been advised that submitting samples from living and deceased subjects, on the same form could present any problems. The Chief Medical Examiner also states that he has never been given any instructions to submit samples separately.

The Medical Examiner"s Office should work with the Department o Public Health to 1) establish a protocol and form which segregates living from deceased subjects for HIV screening and 2) obtain the appropriate authorization to submit blood samples for HIV testing, that are not part of any State or federally funded AIDS surveillance project.

Basis for Testing Medical Examiner Office Employees for HIV and Hepatitis B

The nature and conditions of the work of several classifications of employees, in the Medical Examiner"s Office, place those employees at risk for contracting bloodborne diseases. Pathologists, forensic autopsy technicians, lab technicians, investigators and office personnel handling property are all potentially exposed to bloodborne pathogens, including Hepatitis B and AIDS. To provide employees with a means of monitoring the effects of their exposure, avoid the further spread of any disease and generally safeguard the health of the staff, testing and inoculations are provided to employees for Hepatitis B, HIV, tuberculosis and influenza.

Federal regulations require that all employees exposed to Hepatitis B receive testing, upon request, and that the vaccine be available to them in order to prevent inoculation. In order to comply with this requirement, the Medical Examiner"s Office offers Hepatitis testing, and vaccinations to employees. The results of all Hepatitis B tests conducted are reported to the state. As a result of this reportable condition, Hepatitis B tests may be given with the less stringent standard of "informed consent" of the person being tested. However, testing for HIV is not reportable to any state or federal authority and thus, must be conducted with the individual"s prior knowledge and more stringent standards of written consent, stipulated in the State Health and Safety Code. Even if informed consent was the requirement for HIV testing, the requirements of providing informed consent cannot be met by simply telling the individual being tested that the testing procedure is voluntary.

At the present time, two individuals have filed actions against the City, claiming they were involuntary tested for HIV by the Medical Examiner"s Office. The Medical Examiner"s Office reports that one action has been dismissed in a summary judgment but is on appeal. The second action, an Equal Employment Opportunity claim, is pending.

Even though one case was dismissed, the individual who filed suit still has the right to appeal the judge"s ruling on the summary judgment. Should either of the individuals prevail in their actions against the City, the City could be ordered to award damages for having failed to follow its procedures in connection with these tests.

Providing Influenza Vaccines and Screening for Tuberculosis and Other Testing

The Medical Examiner"s Office participates in a surveillance program run by the TB Control Division of the City"s Department of Public Health. As previously noted, the Medical Examiner"s Office provides screening for tuberculosis for employees. This service is provided as a courtesy to staff members who are exposed to this disease. Investigators, Pathologists and lab workers have the most exposure to the airborne organism which causes tuberculosis. However, any employee who requests a skin test for tuberculosis, and has tested negatively in the past, can receive one.

Employees are notified of the availability of testing through a memorandum issued by the Chief Medical Examiner. The memorandum also informs employees who test positively for TB or who have had a prior diagnosis of TB that chest x-rays are available. The chest X-rays are arranged through the Administrative Coroner. The only cost to the Medical Examiner"s Office for conducting TB skin tests is the cost of the syringe and the Cost of the Chief Medical Examiner"s time.

In addition to providing TB skin tests, the Medical Examiner"s Office makes tetanus toxoid booster shots and flu shots available to employees. Flu shots are also made available to the Homicide Division of City"s Police Department. Immunization is voluntary but highly suggested by the Chief Medical Examiner in specific cases.

Tetanus toxoid booster shots are recommended for all employees who, as part of their duties in the Medical Examiner come into contact with sharp objects such as razors, needles, or glass, or who work in areas or situations where they can abrade or cut themselves. All employees are encouraged to obtain flu shots prior to flu season. In information provided by the Chief Medical Examiner, the recommendation for flu shots stems from the public health, investigatory and disaster response responsibilities of the Medical Examiner personnel.

Informed Consent for Tuberculosis Skin Tests, Tetanus Toxoid Booster Shots and Influenza Vaccines

Unlike the state requirements for testing individuals for Hepatitis B or HIV, there are no specific requirements for informed or written consent prior to administering tests or vaccines. The initial memorandum issued by the Chief Medical Examiner to his staff, and the staff of the Crime Lab, Homicide, the Photo lab and Crime Scene Investigations for the City"s Police Department, on September 20, 1996, simply states that a supply of flu vaccine has been received and anyone wanting a vaccine should contact the Medical Examiner"s Office. A second memorandum circulated by the Chief Medical Examiner on October 4, 1996 fully explains the rationale for obtaining the influenza vaccine, describes the origin of the vaccine and possible adverse reactions.

Individuals receiving TB skin tests, and vaccinations as part of a physical examination or office visit to their doctor, receive information on the test or vaccine prior to having it administered. This process of providing informed consent provides the individual with information to determine whether or not they wish to subject themselves to the procedure. Additionally, it provides the doctor with some degree of protection should anything injurious happen as a result of the test or vaccination. When such tests and vaccinations are administered by a person"s regular physician, or in a clinical setting, the health care worker administering the tests and vaccinations either: 1) has the individual"s medical history available, has access to such records or can take the time to obtain some medical history from the individual to be tested or vaccinated; and 2) has the ability to mount procedures to counteract a severe adverse reaction to the test or vaccine administered.

The coordinator of the Influenza Program for the City"s Department of Public Health, and the Visiting Nurses Association both informed the Budget Analyst staff that there have not been many problems with adverse reactions to the flu vaccine. However, each organization also stated that there is always a possibility of a severe adverse reaction to any vaccine. To guard against any problems that may arise as a result of an individual reacting adversely to the vaccine some clinicians will ask persons receiving the flu vaccine about specific allergies.

As previously noted, written consent is not required to administer a TB skin test, or vaccination for flu or tetanus. However, as an added precaution, the Medical Examiner"s Office should require that any person requesting a TB skin test or inoculation of any kind, sign and submit a consent form indicating that they are aware of the risks, and that they are voluntarily submitting to the test or inoculation. Such protocol does exist for the practice of administering flu shots.

During the field work for this audit, the Budget Analyst"s staff observed the Chief Medical Examiner administering a flu vaccine. The individual being vaccinated was not asked any questions regarding allergies, nor were they observed signing a consent form. This may have been an isolated incident, as the Budget Analyst"s staff does have evidence that persons receiving flu vaccinations sign a consent form. The Medical Examiner"s Office should make sure a few basic medical history questions are always asked of each individual in order to determine whether or not the person requesting the vaccine should, in fact, receive the vaccination and the likelihood of the person having an adverse reaction to the vaccine. The questions could be as basic as: 1) "Have you ever had this type of test/vaccine before?"; 2) Have you ever had an adverse reaction to this type of test/vaccine?"; 3) "Are you allergic to any medications?"; and 4) "Do you currently have, or have you ever had an allergy to eggs or other media used to generate a vaccine?". Taking such actions would not be administratively burdensome and would reduce the City"s exposure to legal actions which could be filed should an individual experience any adverse reaction to the test or vaccine.

Practices in Other Medical Examiner Offices in California and Selected Jurisdictions throughout the United States

As part of this audit, the Budget Analyst surveyed other Medical Examiner"s and Coroner"s Offices in California and throughout the United States. Federal Occupational Safety and Health Agency standards require that all employees who are at risk of contracting Hepatitis B as a result of exposure through work related duties, must be offered testing and vaccination for Hepatitis B. All of the jurisdictions surveyed are in compliance with this federal regulation. However, there were no other jurisdictions where the Medical Examiner/Coroner"s Office routinely provided testing for HIV, TB skin tests, or vaccinations for influenza or tetanus toxoid boosters.

Jurisdictions that did not offer to provide HIV testing or vaccinations for employees cited numerous reasons for their practices. Most common was the opinion that an individual employee"s HIV status was not of concern to the Medical Examiner/Coroner. Los Angeles County indicated that in the case of a needle stick or exposure to blood or other body fluids, the Medical Examiner/Coroner would agree to test the decedent for HIV but not the employee. Los Angeles also does not offer flu or tetanus shots to employee"s. According to the Laboratories Director for the Los Angeles County Medical Examiner/Coroner"s Office, all employees who are at risk of exposure are allowed to obtain a physical examination at the County"s expense. At that time, if an employee wishes to obtain a flu shot, tetanus toxoid booster, or HIV test, they may do so. However, the Director of Laboratories stated that he believes it is not appropriate for the Medical Examiner/Coroner to administer flu and other vaccines, or any personal medical services to employees.

Conclusions

The Medical Examiner"s Office"s current practices and procedures used to provide HIV tests for employees does not meet the written consent requirements established in the California Health and Safety Code. Additionally, the Medical Examiner"s Office"s practice of testing samples from living subjects, is contrary to State law. Both of these situations expose the City to legal and financial risk.

The Medical Examiner"s Office also could help ensure that no potential claims are brought against the City by requiring written consent from all employees receiving vaccinations and screening for tuberculoses. While this is a significant service to employees and in actuality presents a very small risk, a change in procedure, requiring informed consent and/or written consent, would mitigate the City"s exposure to legal actions and financial claims.

Overall, the Medical Examiner"s Office has failed to enforce developed guidelines for testing employees and providing immunizations that comply with the regulations set forth by the State of California, and informed consent practices used by medical personnel in clinical settings. As a result, two employees have allegedly been tested involuntarily for HIV and without required written consent. Additionally, the City is unnecessarily exposed to legal actions that could result from an employee"s adverse reaction to vaccinations provided by the Medical Examiner"s Office.

Recommendations:

In order to comply with state code and minimize the City"s risk of exposure, the Medical Examiner"s Office should:

I.1 Review and consistently enforce policies and procedures for testing employees for HIV which include:

• reviewing and consistently using forms for employees to complete and sign, granting the Medical Examiner"s Office permission to conduct the requested HIV test, and requiring the person administering the test to certify receipt of the form containing the employee"s signature consenting to the procedure;

• requiring the physician to have physical possession of the completed and signed consent form from the individual to be tested prior to drawing a blood sample; and

• establish a secured file to house the consent forms of individuals who are tested and maintain the completed and signed documents for a period of no less than three years as required by State law.

I.2 Establish a protocol and form which segregates samples submitted for HIV screening for living and deceased subjects and work with the Department of Public Health to obtain the appropriate authorization to submit blood samples for HIV screening that are not part of any State or Federally funded AIDS surveillance projects.

I.3 Enforce the established informed consent protocol to be administered to all employees who are either tested for or receive vaccinations for Hepatitis B.

I.4 Enforce the established informed consent protocol to be used when administering flu and all other vaccines to employees in order to reduce the City"s risk of exposure to legal actions due to adverse reactions to such vaccines.

Costs/Benefits

As a result of the Medical Examiner"s Office"s practices with regard to HIV testing for employees, two claims have been filed against the City and County of San Francisco, alleging they were tested involuntarily for HIV in July of 1994. As of the writing of this report, the Medical Examiner"s Office reports that one law suits has been filed and dismissed, in favor of the City, in a summary judgment and the other action, and Equal Employment Opportunity claim, is pending. Consequently, no monetary damages have been paid by the City with regard to these matters. By implementing the recommendations noted in this section, the City"s risk of exposure from allegations of improper testing would be reduced significantly.

Additionally, the City exposure to risk resulting from adverse reactions to vaccines administered by the Medical Examiner"s Office would also be reduced significantly by enforcing the established informed consent protocols. These recommendations would require a change in procedure but would not require the implementation of new testing and vaccination policies. All of the recommendations could be implemented at no cost to the City.