Pre-test Consent/Counseling & Medical Records Controversies in SF & NYC
"Officials move to block HIV testing changes"
Normalization of HIV, activists vs health officials
by Zak Szymanski
Bay Area Reporter
Following last week's announcement from Dr. Jeffrey Klausner that San Francisco had dropped its counseling and written consent requirements for HIV testing, San Francisco Supervisor Fiona Ma introduced a draft ordinance to mandate informed written consent as well as pre-test counseling at city-funded HIV testing sites, according to Bill Barnes, an aide in Ma's office.
Barnes said the draft of Ma's ordinance was introduced on the evening of Tuesday, May 23. Ma's office did not return phone calls from the Bay Area Reporter until the afternoon of Wednesday, May 24, after the print version of the newspaper had already gone to press. A public hearing on the proposal is expected June 5.
Dr. Mitchell Katz, director of the San Francisco Department of Public Health, said he would support a "sensible measure" from the Board of Supervisors to clarify and possibly retract the recent actions of Klausner, who serves as DPH's director of STD services. Katz emphasized that the original policy change was administrative and actually did not remove the city's counseling practice or do away with informed consent, but that Klausner's actions and statements to the media did not clearly state the department's intent.
"I think Jeff so mishandled the information that at this point it would be beneficial for the board to say there must be pre-test counseling, because doubt has been created and it would be valuable for the doubt to go away," Katz told the B.A.R. on Wednesday night.
Ma's ordinance comes in response to numerous concerns over the new HIV testing policy that many HIV/AIDS advocates first heard about in the media or through a press release.
"I wholeheartedly support her goals," Supervisor Bevan Dufty said of Ma's proposal. "It is disconcerting to me that a DPH manager is setting policy without the direct support of the director of public health or the mayor. And I'm troubled by AIDS policy by press release."
Activists and advocates on all sides of HIV policy debates had strong opinions over the policy change. The news was seen as progress by those who seek to streamline and normalize HIV testing, while others feared that relaxing testing standards in the age of HIV names reporting was the beginning of the end of medical privacy.
On Tuesday, May 23, DPH's Katz told the B.A.R. that it would be incorrect to attach political meaning to what was in fact a simple administrative change bringing some city facilities in line with what was already standard practice at most hospitals.
Katz also said that counseling and informed consent had not been dropped, and that the only recent policy change was eliminating one piece of paper from city-funded test sites -- an error-prone laboratory form that simply documented that the counseling and consent had taken place.
"There is no dropped counseling requirement. I do agree that a very minor bureaucratic change is being used to herald in some broader changes which may be beneficial but which will not happen unless there is a greater San Francisco process," said Katz. "All that's transpired to date and all that I support to date is that patients who are being cared for at General Hospital or one of our community clinics or consortium clinics have to be counseled and given informed consent about HIV, but no additional lab form has to be signed. And that's the current way most hospitals and most labs operate in San Francisco."
But after the B.A.R.'s print deadline, Katz added that he believed Klausner handled the policy change so poorly that it would be wise for the Board of Supervisors to pass an ordinance to clarify that consent and counseling would remain in practice. Katz said he would remain opposed to the lab form, but if the supervisors wanted to mandate written consent (rather than informed consent which is still practice), he would advocate that it be documented in a patient's chart rather than on a separate piece of paper.
"What [Klausner] cleared with me was we're not going to use the form anymore. And I still hold fast on that; that form was dumb," said Katz, who added, "Jeff deserves this flack for how this was done...when he struck the language on pre-test counseling he thought he was doing something else."
Katz said Klausner's controversial "removal" of counseling actually was supposed to be nothing more than an acknowledgement that the city already has been using medical providers, rather than certified counselors, to perform HIV tests.
"I have since asked [Klausner] about striking the language that
Dr. Jeffrey Klausner
required pre-test counseling, and it seems that what he thought he was doing was acknowledging that we do not have certified counselors who are always doing the testing," said Katz, who added that Klausner agrees on the need for pre-test counseling and that doctors have been providing that counseling to their patients who get HIV tests. "Removing the form doesn't mean doctors will stop what they're doing."
Katz did acknowledge that terms like "informed consent" and "counseling" rarely have a uniform statewide legal definition, and that some patients, such as regular testers, may not be required to go through counseling each time they are tested by a physician. But he said he has not seen data showing that people who have signed a consent form have necessarily been better counseled or informed than those who give oral consent to be tested.
Barnes agreed that there were "many different ways" counseling could take place, but told the B.A.R. that a written consent form which also included information about the HIV test and behavioral risks would at least ensure that the patient received the information. He said that while most city doctors probably would be thorough and trustworthy, it was important to provide clear safeguards considering that San Francisco often serves as the worldwide model for HIV policy.
Katz said he also disagreed with his Klausner for making media statements to the effect that the new policy was politically significant or indicative of more sweeping changes to come.
"People on both sides of the 'normalize HIV' aisle are now seeing this as a bigger thing. One place where I disagree with Jeff Klausner is his quote that the new policy means San Francisco is ahead of the curve," said Katz, referring to the May 17 Associated Press story where Klausner said the city once again was "taking the lead" when it came to HIV policy.
"SF General is just now adopting the same testing rules the rest of the hospitals have," said Katz, "so clearly [Klausner] is using this to say we are one step toward normalizing HIV testing."
Although Katz said he has mixed opinions and can see "benefits and risks" to normalizing HIV and treating it like other diseases when it came to policy, he emphasized that any such changes would "require a very different process" of public input.
But Jeff Sheehy, HIV/AIDS policy adviser to Mayor Gavin Newsom, said removing written consent from some testing sites means there still has been a significant change whether or not political consequences were intended.
"You did have to sign something before, and that's why I think there's a problem now. I have seen no data nor heard from any ethicists that this policy needed to be changed," said Sheehy, who said he is particularly concerned about eliminating proof of consent given the newly passed state law requiring names reporting of people who test HIV-positive at confidential testing sites (anonymous testing sites are not affected).
Without documented informed consent, Sheehy fears, there are more opportunities for people to be reported to the government as HIV-positive without even knowing they were tested in the first place. This may be especially true, he said, at city-funded testing sites like the Castro-Mission Health Center where there may be language barriers (in general, the new city policy affects General Hospital and primary care health centers, but will not affect City Clinic, which receives its HIV testing funds from the state).
"For me, I can't really separate names reporting from the issue," said Sheehy. "If it's not an anonymous test you should have proof that the person consented to the test, because the consequences of a positive test have grown."
The main motivation for the policy change is efficiency, said Klausner, who said the ability to test more people would mean the ability to treat more people and prevent them from infecting others.
Speaking to the B.A.R. last Friday, May 18, Klausner referenced some data as justification for the change - recently, he said, he took a sampling of 500 people who sought HIV tests at SF General Hospital in January 2006 and identified 50 tests that could not be performed due to some glitch on the lab form in question. Of those 50 delays, he said, half of those people never returned to have their blood drawn again.
"That's 25 tests that weren't done, where a patient agreed to have it done and the doctor agreed to have it done and the test wasn't done," said Klausner, adding that the recent elimination of the form would "eliminate that scenario - where tests obtained through consent process are not done because of an administrative issue, which to me is a big disservice to medical care."
Addressing Sheehy's scenario of HIV-positive names being reported without patients fully consenting to the test, Klausner said that some training might be necessary to ensure that doctors understood that "good medical practice dictates whenever they test someone for any medical infection, they should tell people what the consequences of having a positive test are."
"It's still an informed consent process mandated by law," said Klausner. "It just means that instead of requiring a written additional piece of paper which both patient and doctor have to sign, it can just be documented in the chart and it takes the laboratory out of the role as the agent that assures informed consent occurs."
Sheehy, however, sees much of Klausner's reasoning as arguments in favor of even stricter rules.
"He's saying because they can't handle paperwork we no longer need to have written informed consent. That gives me pause and makes me want to go the other way and get triplicate informed consent. Maybe we actually ought to be going back and making sure the original consent was obtained in an appropriate manner," said Sheehy. "If the argument is that problems with paperwork means we need to write fewer things down then maybe some of those people wouldn't want to be tested anyway."
Sheehy also wondered why, if the policy change was so minor, Klausner seemed intent upon politicizing it.
"It seems very provocative to politicize the issue. It doesn't accomplish any public health goal, and in fact it wreaks havoc on those goals by creating a mistrust between the public health system and the community," he said, adding that he hopes the Board of Supervisors or state legislature will pass mandatory written consent in response to some recent political HIV developments.
As he did in other media outlets, Klausner described the city's policy change to the B.A.R. against a backdrop of broader political reform around the country to treat HIV like other diseases and streamline testing protocol. As proof of the changing landscape he referenced a bill in the California Legislature by Assemblyman Mark Leno (D-San Francisco) that is aimed at revamping some of the more tedious counseling requirements at state-funded HIV testing sites such as City Clinic.
AB2280, said Leno, asks the California Department of Health Services to revisit its current counseling requirements for HIV tests so that, resources aren't wasted and more people can get tested and prevent future transmissions. Of particular interest is the almost infamous multiple-question risk assessment survey administered by a service provider, often in a lengthy fashion. For those who have tested recently, or test often enough that they can enter their own risk data into a computer, it may make sense to eliminate some of the obstacles to quicker testing.
"This bill is very much about setting a floor, hardly a ceiling. We want to address the fact that the epidemic has changed in significant ways since we last revisited risk assessment and prevention counseling as a part of the HIV test process...by innovation such as a brief risk assessment mechanism where people can self-administer data collection, or where appropriate, some basic prevention education in groups instead of one on one," said Leno. "If we can be more effective in the use of our resources, it will result in more people being tested. We know that when people test HIV-positive, the vast majority take steps to prevent the infection of others. Hence...more testing effectively reduces the spread of HIV."
Unlike the new city policy, Leno's bill does not specifically ask the state to look at the process around informed consent, though in reviewing the counseling protocol the state may decide to review those issues as well.
As for San Francisco's new policy regarding written informed consent, Leno said he trusts both HIV activists and policy makers to have pure motivations and an honest dialogue about potential concerns.
"We have had the world's model in San Francisco from day one, and I think our leadership has earned itself credibility and a recognizable trust. Activists by definition exist to be vigilant, and their eyes will be watching," said Leno. "Steps will be taken to make sure people are fully informed. The idea here is not to be cavalier."
HIV Activists Tell New York Department of Health to Stop Gutting Informed Consent Laws
(New York, NY) - HIV activists are demanding that the New York State Department of Health stop illegally collecting medical information on people with HIV and stop its illegal end run around New York law requiring informed consent for HIV testing.
The HIV Law Project, the New York Civil Liberties Union, the American Civil Liberties Union and South Brooklyn Legal Services presented the demand in a letter that the organizations sent to the New York Department of Health. The letter threatens the Department of Health with a lawsuit unless it changes the policies.
"The state clearly has a responsibility to protect against the spread of HIV, but that doesn't put it above the law," said Cynthia Knox, Deputy Executive Director of the HIV Law Project. "The Department of Health has used the false threat of an emergency to undercut laws that were put in place to protect medical privacy and allow people to make informed decisions about their treatment."
According to the letter, since the Department of Health announced that it had identified a so-called "super bug" infection on February 12, 2005, it has repeatedly overstepped its authority by requiring mandatory reporting of individual medical data regarding HIV care and treatment to the Department of Health. This change is in violation of state law, which guarantees greater medical privacy. Rather than permitting public debate about whether mandatory reporting of this data will actually help patients or aid in preventing the spread of the disease, the state has illegally sidestepped the required rulemaking process by repeatedly reissuing on an "emergency" basis these regulations requiring the reporting of private medical information well beyond what the law authorizes.
In addition, the state has gutted important laws mandating that patients be tested only after giving informed consent, both by removing the requirement that test administrators instruct patients of their rights when they ask for consent and by significantly changing the consent form. While the original form made it clear that the patient was consenting to a single HIV test, the new form tries to serve as a "one time for all time" consent that would authorize all subsequent HIV-related testing without any further notice to the patient.
More than two months after the Department announced that it had identified a so-called "super bug" infection, it filed a notice with the state on April 25, 2005, claiming that emergency circumstances called for changes in public health policy. Since it initially asked for the emergency policy changes, the Department has extended the emergency regulations four times: July 21, 2005, October 19, 2005, January 17, 2006, and April 18, 2006.
"Even if the esuper bug' scare had warranted the initial emergency regulations, there has been plenty of time to hold an open debate on the merits of the changes, and that hasn't happened," said Elisabeth Benjamin, Reproductive Rights Project Director of the New York Civil Liberties Union. "The Department is playing fast and loose with the law to illegally collect medical information and keep people in the dark about their medical treatment. HIV is still a very scary disease. People deserve education and counseling to help them cope with such a life changing diagnosis."
While the emergency policies have been in effect, New York City Health Commissioner Thomas Frieden has been advocating for permanent changes in New York law, claiming that the informed consent requirements discourage people from getting testing. Frieden claims that the changes are necessary because of the high percentage of people who don't know their HIV status, yet he offers only anecdotal evidence that written informed consent and counseling are the real barriers that prevent people from getting tested.
HIV advocates agree that the increased prevalence of HIV in communities of color is of great concern. However, they say, it is wrong to strip individuals who have too often received substandard health care at the hands of both public and private agencies - particularly people of color and people with lower incomes and people with limited English proficiency - of their ability to receive HIV education and to make informed decisions about the tests performed on them.
"Twenty-five years into this epidemic, people with HIV/AIDS continue to be fired from their jobs, kicked out of their homes and refused medical treatment," said Sharon McGowan, a staff attorney with the ACLU AIDS Project. "If the government wants to do something to get people tested, it should improve access to quality health care and make efforts to end the discrimination, not take away their ability to make educated decisions."
Just last month, Public Advocate Betsy Gotbaum released a survey finding gross inadequacies at the city's ten clinics that treat sexually transmitted diseases including HIV. The survey found that four of the clinics were unable to assist Spanish-speaking callers, services were not available at all at the East Harlem clinic, and rapid HIV testing was unavailable at two of the clinics. Additional information about the survey is available at: pubadvocate.nyc.gov.
A copy of the letter sent to the Department of Health is available at www.hivlawproject.org or www.aclu.org.caseprofiles.