Participant Informed Consent: The community feedback period for this idea began on 4/12/2019 and ended on 6/12/2019. *STATUS UPDATE*

What is the problem that needs to be addressed? Please describe how it is related to mental health.
Difficulty and complexity exist around informed consent among people experiencing homelessness and/or mental illness and other vulnerable populations. There is not enough epidemiological data to better inform the participants of potential benefits and risks associated with the interventions nor to evaluate the effectiveness of the interventions targeted at these populations.

Why is this a concern for Orange County? What can Orange County and other counties learn from this project?
There is a need to document the potential risks associated with interventions, in particular, those that arise from potentially suboptimal living conditions/environment of shelters hosting this population. People experiencing homelessness and/or mental illness then need to be fully informed of these risks before making a decision to participate in the interventions.

What is currently being done to resolve this problem in our county and throughout the United States? If applicable: Is it working; why or why not?
Patient safety has been an important issue in public policy. However, there are not enough studies on the cause of morbidity and mortality at a system level.

What is new or different about this project idea? Please describe how this differs from what is already being done (Question 6). Please list any research that was done on this topic.
The proposed project should establish a prerequisite for the discipline of medicine for the homeless population.

Additional Information:
From this proposed project, we can learn potential difficulties surrounding conducting system level research while managing patient safety risks and providing adequate informed consent. The goal of this project is to gain assurance that there are few to no legal risks associated with collecting/analyzing/sharing information and that people experiencing homelessness/mental illness have access to all relevant information to make informed decisions.

Additional comment from submitter:
There are a number of negative factors that can be involved with supportive housing, including housing failure, housing instability, and loss of personal property between moves. In addition, living with a roommate has its risks, including injury and property damage. These factors should be assessed and addressed.

March 29, 2019


Thank you for your submission. The innovation team needs additional information, please elaborate on your responses as best as possible so that we may work through our review process.

• Is what you are proposing a collaboration with Orange County homeless shelters to study and measure the risks to those who stay in these shelters in order to provide this information to those who may stay in one of these facilities?

• What would be the specific learning objectives?

Access to essential development metrics ( for the mental health community are deficient ( As an example, assessing suicide risk is a quality measure. However, after the suicide risk assessment, there is no quality measure for what intervention to use to prevent suicide – a very important piece of information to have if one wants to reduce suicides. The metrics many seem to be focused on are housing and employment. Other metrics, such as life expectancy, are not measured, or at least not easily available nor publicized. Anecdotal evidence supports a hypothesis that leaders of Orange County mental health/poverty services do not track life expectancy in their program and show no curiosity for this very important metric. This is despite the fact the metric is easy to calculate/estimate: summate the ages of all the homeless/mentally ill people who died in the past year in a particular program/jurisdiction and divide by the number of people whose ages were summated. This one metric can be sliced and diced by ethnicity, diagnosis, family history, etc. Public policy can house and employ the population experiencing mental illness, but if life expectancy declines ( the public policy is a fail. The above paragraph describes a balanced scorecard approach to measuring success/failure which should be new to no one. Applying a balanced scorecard to mental health services is novel.

What was learned from 1999 To Err is Human Report from the Institutes of Medicine is that identification and collection of essential metrics/key performance indicators may not have occurred because of legal disincentives to doing the research. Treble damages for patient safety research discovered during medical malpractice litigation was identified as one barrier to collecting and sharing data. This submitter does not know if California has a safe harbor for patient safety research in relation to med-mal treble damages – which would be one aspect that this project seeks to answer. Such a safe harbor, if it exists, would likely be for medicine in general and not specific to mental health. Regardless, understanding the strategy in place for patient safety in medicine, in general, is part of this proposal. Moving beyond medicine in general, Orange County, like many other jurisdictions, is moving to novel approaches to mental health care. Contracts are awarded for organizations with competing strategies for addressing mental health. These new strategies may not fit whatever patient safety public policy already exists (i.e. the patient is redirected from a healthcare setting such as a psychiatric ward to a Wellness Center, Peer Support Program, Crisis Intervention, etc). Thus whatever policy does exist for medicine is lost because the setting has legally changed (i.e. a Wellness Center may not be considered a healthcare setting legally) and competing strategies for similar services cannot be compared because the incentives for data sharing no longer exist. Contractors may assume they exist and then be surprised during litigation to the contrary. This paragraph describes understanding the current public policy for medicine in general to share patient safety data, identify deficiencies, and understanding how the existing public policy, in general, may no longer apply as the mental health setting looks less and less like a Psychiatric Inpatient Ward/Outpatient Clinic.

Above describes strategies to collect data through safe harbor provisions/other public policy and identify the key performance indicators that a mental health consumer can use to identify quality choices for their own care.

Below describes strategies to share identified KPIs described above with Informed Consent to mental health consumers.

As identified in the original, unedited submission, there are KPIs that a consumer can use to compare mental health choices. Associated information that is imperative to a mental health consumer is how to fit the inclusion criteria and avoid the exclusion criteria for these mental health choices. Inclusion/Exclusion criteria are somewhat arbitrary, for example, discontinuing private health insurance eliminates an exclusion criterion for many Orange County Behavioral Health resources. There are likely many, many other examples. Making these easy changes can dramatically impact a person’s choice for mental healthcare. However, these easy changes may be irreversible. Thus, knowing which program to choose – based upon sharing program specific KPIs – can better guide a person to make the “correct” changes for the “correct” inclusion/exclusion criteria for the “correct” program based upon the consumer’s goals for recovery. At its most basic level, the above paragraph describes an analogous process as going to the supermarket to buy milk, reading the printed expiration date and selecting a milk carton that is not expired. Choosing quality however defined by the consumer and the consumer’s recovery.

Ethical requirements are needed to provide informed consent because data can be used to deceive.

To summarize:

The “Safe Harbors” goal of this project is to understand the public policy that currently exists for patient safety in California, understand if this public policy is nullified by the changes in settings for mental health consumers as the healthcare system is reformed/changed, and, perhaps, add public policy that enables collection of KPIs/Informed Consent Dissemination of KPIs.

The “Informed Consent” goal of this project is for consumers to understand the risks, benefits, and criteria for the many choices available (including choosing the city of habitation) . Homeless shelters are one aspect of Informed Consent. Anecdotal evidence suggests that one shelter may be great for a person recently out of prison who can tolerate hindered access to security, toilets, soap and warm water. For people that don’t fit this demographic other choices may be better. Legal rights can come into play in the issue of enforcing no camping laws vs. available shelter space. Available shelter space may exist, but as referenced above, be unsafe because the shelter does not provide security, adequate sanitation, etc. As referenced in the first paragraph of this response, life expectancy is a KPI that should be tracked, is easy to track, but isn’t tracked. A logical conclusion is that the shelter that does not provide security/sanitation reduces life expectancy for its inhabitants. However, there is no informed consent/KPI data to support such a conclusion. Thus, wild rumor guides choice and not verified evidence. The informed consent is desired for all major choices presented to mental health consumers, not just the choice of a homeless shelter. With such data, the consumer can, at a minimum, avoid the choices that kill faster if that is their vision for their recovery.

There is an opportunity for KPI innovation with this project as well. Again, many are focused on housing (with highly variable quality) and employment (with high marginal “tax” rates estimated at 75% to 100+%). Other needs identified by Maslow and others are neglected. What KPIs are associated with the following: 1) A feeling of Home; 2) A feeling of safety; 3) Obtaining a healthy intimate relationship (likely KPIs involve privacy, feeling of home, feeling of safety, etc); 4) A feeling of accomplishment; 5) A feeling of inclusion/value within a community/reciprocity; 6) A feeling of prestige; 7) A feeling of achieving one’s full potential. Sustainability is a major concern as there is no social contract theory (nor post-litigation assurance) to maintain community investments in mental health that are, as of 2019, implemented at a rapid rate.

What isn’t measured in the neighborhood of precision/accuracy, isn’t incentivized and isn’t attained. Knowing life expectancy is very important for many reasons which can include: 1) Underwriting meaningful, market-based disability insurance to incentivize employment productivity; 2) Underwriting meaningful, market-based health insurance to a standard beyond medical-mental health parity; 3) Reducing wait list times, right-sizing capacity for services such as OASIS (10 years); 4) Personal investment in activities (should I go to college, get a job, or just enjoy life in “retirement”)

After submitting the Mental Health Error Reporting System project idea it is prudent to return to Informed Consent to update the thought process. For clarity, the main outcomes of the Informed Consent project that are meaningful are the safe harbors provisions and clarity of what medical/mental health services/facilities are covered by the safe harbors. The safe harbors I am referring to involve protection of widespread publication of patient safety data, not licensed provider adherance to a deemed right treatment protocol.

What does such a project look like?

I am guessing that safe harbors don’t exist in California based upon the data available to the public. I would hope that someone who knows the answer to this open question would stop this project before bid if they do exist. If my guess is found to be true then there are one of two options. Option 1: Change public policy to institute safe harbors for medical and mental health facilities. Option 2: Bid out an insurance policy to cover treble damages and/or extra risk experienced from open publication of patient safety I would hope that after seeing the cost of Option 2, we could return to Option 1. Option 1 doesn’t fit nicely into an Orange County, CA contract as it would be the State of California being the contractor with a Scope of Work that cannot be accomplished with money alone. Lots of thought would need to be placed into Option 2 as the insurance policy would likely be covering people who don’t have mental illness and thus we have a free rider problem where MHSA funds are going to pay for non-MHSA benefits.

I don’t have access to a two-way conversation about this particular open question with anyone knowledgeable about the topic in California and therefore we now have this INN project proposal. The last I had access to this conversation was in 2008-2009 in the State of Illinois. If I had better access to information and policy then we wouldn’t have this guess of an INN project hanging out here. The cost/consequences of Mental Health Participant Hand off, Morbidity and Mortality Meetings, Mental Health Error Reporting System, WRAP Inclusion and Training, Behavioral Health Housing and Treatment Resources, Improving Patient Care and Vital Development Statistics likely are all influenced by the Safe Harbors provisions of this Informed Consent project. Dissemination of such information could be used during litigation discovery or by a tort Lawyer looking for their next lawsuit/class action suit. The goal of the safe harbor is to not have that risk that prevents learning.

Hopefully, the goal of this project is clearer in the conext of other submittted projects. Again, this project is not likely to easily flow through the process of INN projects in Orange County. I would hope that the process to achieve a safe harbor is followed through and we can get one or know as best we can before court decision that we have one. I would hope that the mental health community could be kept informed on the progress of this issue as it flows through whatever process gets it done.

The American Medical Association has policy positions that better describe the Safe Harbors to which I refer:

Patient Safety H-335.965 ( ) – This policy is in the context of Medicare, but other payers would be involved in our health system.

Health Court Principles H-435.951 ( ). Skip to the section titled Medical Error Reporting. This submitter is not familiar with Patient Safety Organizations ( and the ones listed for serving Psychiatry in California at Behavioral Health Centers are not in California.

Medication (Drug) Errors in Hospitals H 120.968 ( ) Skip to section 2 about reporting.

Thank you for your idea submission. Upon review and discussion, it t is unclear what new learning this project could contribute to the field of mental health. The Innovation team is unable to continue exploring this idea under the MHSA Innovation component as currently proposed.

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