Consent/Privacy: Refresher and Update Lois Richardson California Hospital Association
Privacy Update California Consumer Privacy Act Aimed at Facebook, Google, data sellers, but very broadly written Effective January 1, 2020 New consumer rights to: Know information a business has collected, why and from where Receive a free copy of the info Request deletion, with exceptions Know if business has sold info to others, and prevent future sale
Privacy Update (cont.) Who must comply? Businesses operated for profit that: Have annual gross revenues over $25 million Annually buy, obtain, sell, or share the personal information of 50,000 or more consumers, households, or devices Derive 50% or more of its annual revenue from selling consumers personal information
Privacy Update (cont.) Definitions: A consumer is any natural person who resides in California Personal information means information that identifies, relates to, describes, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer or household, such as real name, alias, postal address, unique personal identifier, online identifier, Internet Protocol address, email address, account name, social security number, driver s license number, passport number, other similar identifiers.
Privacy Update (cont.) Signature, physical characteristics or description, race, gender, color, religion, ancestry, national origin, disability, marital status, sexual orientation, gender identity, medical condition, genetic information, citizenship, primary language, immigration status, phone number, insurance policy number, credit/debit card number, financial information, medical information, health insurance information Commercial information, including records of personal property, products or services purchased, obtained, or considered, or other purchasing or consuming histories or tendencies Biometric information, including DNA, fingerprint, images, voice recordings, keystroke patterns, gait patterns, sleep/health/ exercise data
Privacy Update (cont.) Internet or other electronic network activity information, such as browsing history, search history, and information regarding a consumer s interaction with an Internet Web site, application, or advertisement Geolocation data Audio, electronic, visual, thermal, olfactory, or similar information Professional or employment-related information Education information
Privacy Update (cont.) Inferences drawn from any of the information identified above to create a profile about a consumer reflecting the consumer s preferences, characteristics, psychological trends, predispositions, behavior, attitudes, intelligence, abilities, and aptitudes
Privacy Update (cont.) Exempts: Not-for-profits Medical information governed by CMIA Protected Health Information (PHI) collected by covered entity or business associate Patient information maintained as medical information or PHI
Privacy Update (cont.) Exempts: Information collected as part of a clinical trial subject to Common Rule, good clinical practice guidelines issued by International Council for Harmonisation or pursuant to US FDA human subject protection requirements
Privacy Update (cont.) What is covered? Information held by investor-owned facilities or very large medical groups Employee information Contractors/medical staff Visitor management License plate reader Fundraising
Privacy Update (cont.) CDPH public comment on proposed breach notification rules ended Dec. 9, 2018 We re awaiting publication of final rule
Today We Will Discuss: Why do we obtain informed consent? When is informed consent/informed refusal required? Elements of informed consent/refusal Who obtains consent/refusal from the patient or surrogate? Documentation Choosing a surrogate decisionmaker Questions 12
Why Is This So Complicated? Uncoordinated state and federal statutes, regulations, subregulatory guidance, judicial decisions, accreditation organizations Standard of practice Lots of law/guidelines, but fairly vague therefore different interpretations Complicated human relationships! 13
Why Do We Need to Obtain Informed Consent? Going back to the basics of why helps answer questions Patient s right to self-determination consent must be meaningful Hospital patient rights Title 22, California Code of Regulations (4) Receive information about the illness, the course of treatment, and prospects for recovery in terms that the patient can understand. (5) Receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment. Except in emergencies, this information must include: 14
Why Do We Need to Obtain Informed Consent? (cont.) A description of the procedure or treatment The medically significant risks involved in this treatment Alternate courses of treatment or nontreatment and the risks involved in each The name of the person who will carry out the procedure or treatment. (6) Participate actively in decisions regarding medical care. To the extent permitted by law, this includes the right to refuse treatment. 15
Why Do We Need to Obtain Informed Consent? (cont.) Centers for Medicare & Medicaid Services Condition of Participation (CoP) - Patients Rights Participate in the development and implementation of plan of care Make decisions about care Patient safety don t do procedures the patient doesn t want Patient lawsuits battery, malpractice Patient satisfaction scores Accreditation requirements 16
When Is Informed Consent Required? Informed consent is required If the nature of the treatment is complicated or invasive When the procedure involves material risks that are not commonly understood (layperson test) When required by law (see handout) Informed consent not needed for procedures that are simple and common (but informed refusal may be) CMS requires medical staff to list the procedures and treatments that require written informed consent 17
Consent for Simple Procedures Typical ways consent for simple and common procedures is obtained Patient holds out arm for phlebotomist Patient takes the medicine Patient goes to radiology for the X-ray Typical documentation, if any: the general authorization in the Conditions of Admission/Registration form 18
Informed Consent Process Informed consent is shorthand for a process that involves giving the patient information so the patient can make an informed decision to accept or reject proposed treatment Informed consent is not just a form to be signed 19
Informed Consent Discussion: Content Discussion must include these elements: Nature and purpose of procedure Likely benefits of procedure Material risks, complications, side effects/potential recuperation problems Reasonable alternative therapies and their benefits/risks (include the risks of not receiving treatment) Prospects for recovery/likelihood of achieving goals Name of person(s) performing procedure Any potentially conflicting interests (research, financial) Any other info required by specific law (see handout) 20
Informed Consent Discussion: Content (cont.) What information is sufficient? That information which would be considered significant by a reasonable person in the patient s position Supplemented by patient s unique concerns/condition (as known by the physician) May use patient information sheets Leave enough time before surgery for patient to ponder 21
Informed Consent Discussion: Content (cont.) Communicate (and document) significant risks, including, but not limited to Loss of life Loss of limb, limb function Risk of stroke, brain injury, loss of nerve function Potential for hemorrhage, blood clots Potential for allergic reaction Blood loss necessitating transfusion Infection Other, according to procedure: incontinence, impotence, infertility, paralysis, loss of vision, etc. 22
Informed Consent Discussion: Content (cont.) No obligation to inform a patient about a test or treatment that is not recommended No obligation to advise patient of unapproved treatment» Schiff v. Prados (2001) 92 Cal. App. 4 th 692 No obligation to divulge a small or remote risk» Scalere v. Stenson (1989) 211 Cal. App. 3d 1446 23
Informed Refusal Informed refusal is the flip side of informed consent However, it also applies to simple and common procedures/tests/treatments: glaucoma test, Pap, refusal to see specialist 24
Who Obtains Consent? The physician who will perform the procedure Not the nurse, even if the nurse performs the procedure (PICC) The physician must decide what information to give each patient, which involves the practice of medicine. Must offer to answer questions. What about supplemental patient information sheets? 25
Who Obtains Consent (cont.)? When two or more physicians are involved, either they can divide the responsibility or hospital policy can allocate responsibility Surgeon and anesthesiologist Internist and radiologist 26
What is the Hospital s Responsibility in the Consent Process? The hospital verifies that the physician obtained informed consent and this is documented Chart note by physician documenting the discussion Consent form - must be signed by patient and in the chart prior to surgery One form or two? How detailed? Discussion occurs outside hospital how does form get to the hospital? How about interpreters? How about witnesses? Not required, but TJC will ask about witnessing; staff must know if witnesses are required and who can witness based on hospital policy Informed refusal the same 27
There Are Many Ways to Write a Progress Note About Consent Must be done before surgery Can be done in a summary or detailed way think about surveyors, jurors Patient information sheets can be useful for frequently performed procedures 28
Documentation: The Form CMS requires that the consent form contain at least: Name of hospital where treatment will take place Name of specific procedure to be performed (medical v. layperson description) Name of responsible practitioner who will perform procedure Statement that procedure, including anticipated benefits, material risks and alternative therapies have been explained (don t have to write all this on form but how to prove later?) Signature of patient or patient s representative Date and time the form is signed by the patient 29
Documentation: The Form (cont.) CMS s optional suggestions for a well-designed consent form : Name of practitioner who conducted IC discussion Date, time and signature of witness to patient s signature List of material risks discussed Statement that other practitioners will be performing tasks w/i policy and skill set (required in first draft ultimately taken out) Statement that non-physician practitioners who are participating in the procedure will stay within scope of practice 30
Can a Consent Form Be Stale? There are no strict rules governing how long in advance of the procedure informed consent can or should be obtained. Physician discretion and hospital policy govern. As a general rule: The discussion should occur with sufficient time allowed for the patient to consider his/her decision Common sense, reasonableness and good judgment should apply If the patient evidences doubt or confusion, hospital personnel should contact physician to resolve issue 31
Has Anything Changed? Consent effective until: Revoked, or Circumstances have changed, so as to materially affect the nature of the procedure or risks/benefits - for example, the patient s health has taken a turn for the worse since surgery was originally contemplated Then: the patient and doctor should discuss the planned procedure in light of any changes in the benefits, risks or alternatives Without documentation, it is almost impossible to prove the further discussion happened No need for multiple consent discussions/forms for repeat treatment debridement, infusion therapy, etc. unless circumstances change as mentioned above 32
Consent: Exceptions and Special Circumstances Exceptions to Consent: Emergency Impracticable to obtain consent Patient mentally incapacitated No surrogate decision maker available If prior refusal, and emergency subsequently results, the emergency exception may not apply Business and Professions Code 2397 provides immunity Patient request for non-disclosure 33
Two Physicians and Emergencies An unconscious man who had fallen while hiking was brought to our ER. He needs emergency brain surgery to evacuate a hematoma. He had no ID and we had no way to find his family. Can we do emergency surgery? Two doctors are ready to sign. 34
Two Physicians and Emergencies (cont.) First, let s define emergency. It is when: Immediate services are required for the alleviation of severe pain; or Immediate diagnosis and treatment of unforeseeable medical conditions are required, if such conditions would lead to serious disability or death if not immediately diagnosed and treated 35
Two Physicians and Emergencies (cont.) Second, there is no legal requirement that the physician consult with a second physician to confirm the existence of an emergency However, such consultation may be required by hospital or medical staff policy If no policy requires confirmation, a physician has the discretion to decide if consultation is necessary before the physician proceeds with emergency care w/o consent from the patient 36
But Can t Two Physicians Just Give Consent? The myth that will not die: That two physicians can sign the consent Any two physicians will do They can consent to elective, non-emergency surgery for incompetent patients who do not have a surrogate decision maker No! (We ll discuss unrepresented patients later) 37
Missing or Incomplete Consent Form in OR The patient is in the OR, asleep, and we just discovered that the consent form is missing or incomplete! This needs to be evaluated on a case-by-case basis Missing or incomplete consent form vs. consent Look for evidence of consent discussion in hospital or doctor s office record Obtain consent from surrogate decisionmaker Review the basics: hypothetical laparascopic/robotic lysis of adhesions Do no harm to the patient
New Finding During Surgery In the middle of surgery, the doctor discovered an unexpected problem that he wants to fix now. Can he? Case-by-case evaluation taking into account: Is the finding related to the original procedure? Was it a complication or finding inherent to the procedure? o Law will deem a patient to have consented to a touching that, although not literally covered by the patient express consent, involves complications inherent to the procedure. o Kaplan v. Mamelak (2008) 162 Cal.App.4 th 637 Is there an available surrogate decisionmaker who can consent? Does the emergency exception apply? What does the consent form say? 39
The Patient Without Capacity: Who Decides? Hierarchy: Orally-designated surrogate decisionmaker Agent under AHCD/POA Conservator Court-appointed surrogate decisionmaker Closest available relative (no hierarchy) Multidisciplinary committee 40
Handy Chart 41
Surrogates: The Basic Options Conservators: May or may not make health care decisions depending on scope of authority and patient s capacity status There are restrictions on conservator s authority no placement in mental facility, no consent for experimental drugs, no convulsive treatment For withdrawal of life-sustaining treatment, must prove by clear and convincing evidence that the conservatee wished to refuse care. (Other surrogates standard is by preponderance of evidence) 42
Surrogates: The Basic Options (cont.) Court petition to: Determine that a patient has capacity to make health care decisions Determine that patient lacks capacity and to order a specific treatment or to designate a person to make a health care decision This process should be used only if there is a probability that the patient s condition, if not treated, will become life-endangering or pose a serious threat to the patient s physical or mental health (Probate Code 3200 et seq.) 43
Surrogates: The Basic Options (cont.) Applying for Temporary or Permanent Conservatorship not always viable if: Patient s care cannot be postponed Patient s lack of capacity is temporary Patient objects to conservatorship 44
Surrogates: The Basic Options (cont.) Public Guardian application if: Patient appears to require a guardian or conservator It appears that no one else is qualified or willing to act Appointment would be in best interests of the person (Note: Not usually the best choice) 45
Use of Family and Others as Surrogates The Barber and Cobbs cases provide the best guidance: Cobbs: if the patient is a minor or incompetent, the authority to consent is transferred to the patient s legal guardian or closest available family member Barber: Court approved the use of wife and children; acknowledged that the law does not specify that only court-appointed surrogates can make decisions 46
Statement of California Legislature In the absence of controversy, a court is normally not the proper forum in which to make health care decisions, including decisions regarding lifesustaining treatment (Probate Code Section 4650(c))
Use of Family and Others as Surrogates Domestic Partners: Registered domestic partners: Have the same authority (and limitations) as a spouse to make health care decisions for each other Hospital policy: Any hospital policy regarding proof requirements should apply equally to spouses and registered domestic partners Note: Non-registered domestic partner may qualify as a surrogate decisionmaker also 48
Selection of a Surrogate In selecting family surrogate decisionmaker, consider which family member: Is most familiar with the patient s values and medical decision-making desires Would be most affected by the treatment Has expressed a concern or interest in the patient s welfare» Barber v. Superior Court 49
Selection of a Surrogate (cont.) Use Ethics Committee CMA/CHA policy on Selection of Health Care Surrogates with the Assistance of Health Care Professionals (Consent Manual, Appendix 2-C) Discusses suggested sources of information Discusses characteristics of surrogate decision maker Discusses duties of physician and other health care professionals CMA/CHA policy on Health Care Decisions for Unrepresented Patients (Consent Manual, Appendix 2-D)
Selection of Surrogate: CMA/CHA Model Policy Selection of Surrogates CMA/CHA Model Policy: In the absence of a designated or appointed surrogate decisionmaker, physicians may identify a surrogate who appears, after a good faith inquiry, to be best able to function in this capacity. Input from the following may be helpful: Family and friends of the patient Other health care professionals Ethics committee Social workers Chaplains 51
Selection of Surrogates: CMA/CHA Model Policy (cont.) Relevant factors in selecting a surrogate: Familiarity with patient s personal values Demonstrated care and concern for the patient Degree of regular contact with the patient before and during the patient s illness Availability to visit the patient 52
Selection of Surrogates: CMA/CMA Model Policy (cont.) Availability to engage with health care professionals Ability to understand medical condition Ability to assume duties of surrogate Previous designation as surrogate, but authority has expired 53
Selection of Surrogates: CMA/CHA Model Policy (cont.) Duties of surrogate Same responsibilities/limitations as agents or other surrogate decisionmakers Under these circumstances it is important that the surrogate be willing to obtain information about patient s known values and beliefs from patient s friends and family Surrogate will be asked to assist in communications with relatives and friends of the patient as they are necessary for good medical care 54
Selection of Surrogates: CMA/CHA Model Policy (cont.) NOTE: Agreement by a potential surrogate with the treatment recommendations of the physician or other health care professional should not be a criterion used in the selection of a surrogate. 55
Selection of Surrogates Hospital should not rely on family members if: The relative s decision making capacity or motives are suspect There is a serious question whether the patient would consent Another close relative objects to the medical treatment 56
Unrepresented Patients How often do we have patients who have no one to speak for them? No family No friends The law is anything but helpful on how we manage consent issues for these patients The concept of a model policy was developed by CHA/CMA/Alliance for Catholic Health Care 57
The Unrepresented Patient: CMA/CHA Model Policy Purpose of the policy Provide a process for making ethically and medically appropriate treatment decisions on behalf of persons who lack decision-making capacity and who have no appropriate surrogate decision-maker Provide guidance in the absence of clear-cut legal guidelines that cover these circumstances Modeled on H&S Section 1418.8, which applies to SNFs 58
The Unrepresented Patient: CMA/CHA Model Policy (cont.) Policy involves use of multidisciplinary team with the following members: Attending physician Nurse familiar with the patient Social worker familiar with the patient Chair or vice-chair of ethics committee Non-medical (community) member of ethics committee As available, consulting clinicians and pastoral care staff Policy acknowledges that team membership will vary depending on nature and structure of the institution 59
The Unrepresented Patient: CMA/CHA Model Policy (cont.) Duties of the Multidisciplinary Team Review diagnosis and prognosis for accuracy Determine appropriate goals of care by weighing the following: Previously expressed wishes, if any Relief of suffering and pain Preservation or improvement of function Recovery of cognitive function Quality and extent of life sustained Degree of intrusiveness, risk or discomfort of treatment Cultural or religious beliefs, to the extent known Establish a care plan with a determination of appropriate level of care, including categories or types of procedures and treatment 60
The Unrepresented Patient: CMA/CHA Model Policy (cont.) Guiding Principles No bias based on patient demographics Team will be decisionmaker with same rights and responsibilities as agent Team must assure itself that medical decision is based on: Sound medical advice and Patient s best interests and values 61
The Unrepresented Patient: CMA/CHA Model Policy (cont.) Guiding Principles If all members of team agree, care will be provided or treatment will be withheld or withdrawn If all members of team do not agree on the care plan, team will confer with the ethics committee or other resources to explore disagreement and facilitate resolution 62
The Unrepresented Patient: CMA/CHA Model Policy (cont.) Guiding Principles If continued disagreement: Current treatments will be continued and any other medically necessary treatments provided until court resolution or disagreement otherwise resolved 63
The Unrepresented Patient: CMA/CHA Model Policy (cont.) Exceptional circumstances requiring consultation with legal counsel: Patient s condition result of criminal act Patient s condition caused or aggravated by a medical accident Patient is pregnant Patient is the parent with sole custody or responsible for support of minor child 64
Documentation If the patient has been declared incompetent by a court, a copy of the court order should be obtained and put in the chart If the physician has determined a patient lacks capacity, that determination and facts supporting the determination should be documented Attempts to locate surrogate Findings that no surrogate available Document rationale for selecting surrogate If the patient is unrepresented, document process for decisionmaking Ethics committee involvement 65
Minors and Consent: The Basics Parents have a legal obligation to provide necessities of life for minors, including medical care and right to control care until 18 years old Some exceptions: Status of minor Nature of treatment sought Minor must have capacity to make own decisions 66
CANHR v. Chapman Constitutionality of Health & Safety Code Section 1418.8 is in doubt Lower court opinion on hold
Informed Refusal An adult patient with capacity has the right to refuse any and all forms of medical treatment However, an adult does not have the right to deny life-sustaining treatment for his or her child Attorney/Child Protective Services
Handy Chart http://www.calhospital.org/quick-references-guides 69
Minor Can Consent Based on Status Emancipation By court order (DMV ID) Self-sufficient (15 or older, living apart, managing own finances) Active duty U.S. military Married or previously married Note: parenthood is NOT an emancipating event! 70
Minor Can Consent Based on Nature of Treatment Sought Treatment or prevention of pregnancy, including contraception and abortion Diagnosis, treatment of communicable reportable disease Prevention of STD (HPV vaccine) Rape, sexual assault treatment, intimate partner violence treatment and evidentiary exam (must attempt to contact parents unless they are believed to be perpetrator) 71
Minor Can Consent Based on Nature of Treatment Sought (cont.) Outpatient mental health treatment or drug/alcohol treatment if 12 years or older (parent must be given opportunity to participate unless therapist deems this inappropriate) 72
Remember! A minor has a privacy right in health information whenever the minor has the legal right to consent So no disclosure to the parent allowed! 73
Additional Considerations The person legally responsible for a minor is generally responsible for the minor s financial obligations, BUT not for health care or related services to which the minor may legally consent (THINK pregnancy, family planning, abortion, sexual assault, reportable communicable diseases, substance abuse, mental health outpatient treatment) 74
Don t Forget Divorced parents Stepparents Domestic partner parents Multiple parents Minor parents Guardians Third-party consent/ caregiver authorization affidavit Parents otherwise unavailable Minors born out of wedlock Abandoned minors Foster children Adopted minors Minors in custody 75
CHA Resources 76
Questions?
Thank You Lois Richardson Vice President, Legal Publications and Education California Hospital Association lrichardson@calhospital.org 78