Bill Text: CA AB3161 | 2023-2024 | Regular Session | Amended
Bill Title: Health and care facilities: patient safety and antidiscrimination.
Spectrum: Partisan Bill (Democrat 3-0)
Status: (Engrossed) 2024-07-03 - From committee: Do pass and re-refer to Com. on APPR. (Ayes 11. Noes 0.) (July 2). Re-referred to Com. on APPR. [AB3161 Detail]
Download: California-2023-AB3161-Amended.html
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Amended
IN
Senate
June 19, 2024 |
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Amended
IN
Assembly
May 16, 2024 |
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Amended
IN
Assembly
April 01, 2024 |
CALIFORNIA LEGISLATURE—
2023–2024 REGULAR SESSION
Assembly Bill
No. 3161
| Introduced by Assembly Member Bonta (Coauthor: Assembly Member Jackson) (Coauthor: Senator Rubio) |
February 16, 2024 |
An act to amend Sections 1279.1, 1279.3, 1279.6, and 1419 of, and to add Section 1279.25 to, the Health and Safety Code, relating to health and care facilities.
LEGISLATIVE COUNSEL'S DIGEST
AB 3161, as amended, Bonta.
Health and care facilities: patient safety and antidiscrimination.
(1) Existing law provides for the licensure and regulation of health facilities by the State Department of Public Health. A violation of these provisions is a crime.
Existing law allows for patients to submit complaints to the department regarding health facilities. Existing law also requires the department to establish a centralized consumer response unit within the Licensing and Certification Division of the department to respond to consumer inquiries and complaints.
This bill would require the department to include a section for complaints involving specified health facilities to collect information about outlined demographic factors of affected patients. The bill would require the department to include a section on the Complaint Against a Health Care Facility/Provider form on
the department’s internet website, and provide means for complaints submitted via mail, fax, or by telephone, for complaints involving specified health facilities. The bill would require the department to inform complainants that the information collected is voluntary, is to ensure patients receive the best care possible, and will not affect the department’s investigation. The bill would require that complainants shall be provided with information on how to file a complaint with the Civil Rights Department.
(2) Existing law requires a health facility to develop, implement, and comply with a patient safety plan to improve the health and safety of patients and to reduce preventable patient safety events. The patient safety plan requires specified elements, including, but not limited to, a reporting system for patient safety events that allows anyone involved to make a report of a patient safety event to the health facility, and a process for a
team of facility staff to conduct analyses related to root causes of patient safety events.
This bill would require the reporting system to include anonymous reporting options. The bill would also require analysis of patient safety events by sociodemographic factors to identify disparities in these events. The bill would require that the safety plan include a process for addressing racism and discrimination and its impacts on patient health and safety, including monitoring sociodemographic disparities in patient safety events and developing interventions to remedy known disparities, and encouraging facility staff to report suspected instances of racism and discrimination. The bill would require, beginning January 1, 2026, and biannually thereafter, that health facilities submit patient safety plans to the department’s licensing and certification division. The bill would authorize the department to impose a fine not to exceed $5,000 on health facilities for failure
to adopt, update, or submit patient safety plans, and would authorize the department to grant an automatic 60-day extension to submit biannual patient safety plans. The bill would require the department to make all patient safety plans submitted by health facilities available to the public on its internet website.
(3) Existing law requires the department to provide information regarding reports of substantiated adverse events and the outcomes of those investigations on the department’s internet website and in written form that is readily accessible to consumers and protects patient confidentiality.
This bill would require, commencing January 1, 2026, and annually thereafter, the department to also include demographic information required to be collected. The bill would authorize the department to update this information on the department’s internet website more frequently than annually.
(4) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
The people of the State of California do enact as follows:
SECTION 1.
Section 1279.1 of the Health and Safety Code is amended to read:1279.1.
(a) (1) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law.(2) In addition to the reporting requirements required by Article 11 (commencing with Section 70970) of Chapter 1 of Division 5 of
Title 22 of the California Code of Regulations and Article 6.5 (commencing with Section 71565) of Chapter 2 of Division 5 of Title 22 of the California Code of Regulations, the health facility shall make a good faith effort to provide to the department the following demographic information about the patient:
(A) Age.
(B) Race.
(C) Ethnicity.
(D) Gender identity to the extent known. identity.
(E) Sexual orientation to the extent known. orientation.
(F) Primary language spoken.
(G) Disability status, as defined in Sections 12926 and 12926.1
of the Government Code.
(H) Expected payer.
(3) With respect to the information set forth in subparagraphs (D) and (E) of paragraph (2), a health facility shall only be required to disclose information that is voluntarily provided by the patient or client.
(b) For purposes of this section, “adverse event” includes any of the following:
(1) Surgical events, including the following:
(A) Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient. A reportable event
under this subparagraph does not include a situation requiring prompt action that occurs in the course of surgery or a situation that is so urgent as to preclude obtaining informed consent.
(B) Surgery performed on the wrong patient.
(C) The wrong surgical procedure performed on a patient, which is a surgical procedure performed on a patient that is inconsistent with the documented informed consent for that patient. A reportable event under this subparagraph does not include a situation requiring prompt action that occurs in the course of surgery, or a situation that is so urgent as to preclude the obtaining of informed consent.
(D) Retention of a foreign object in a patient after surgery or other procedure, excluding objects
intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained.
(E) Death during or up to 24 hours after induction of anesthesia after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and for whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance.
(2) Product or device events, including the following:
(A) Patient death or serious disability associated with the use of a contaminated drug, device, or biologic provided by the health facility when the contamination is the result of generally detectable contaminants in the drug, device, or
biologic, regardless of the source of the contamination or the product.
(B) Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended. For purposes of this subparagraph, “device” includes, but is not limited to, a catheter, drain, or other specialized tube, infusion pump, or ventilator.
(C) Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a facility, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.
(3) Patient protection events, including the following:
(A) An infant discharged to the wrong person.
(B) Patient death or serious disability associated with patient disappearance for more than four hours, excluding events involving adults who have competency or decisionmaking capacity.
(C) A patient suicide or attempted suicide resulting in serious disability while being cared for in a health facility due to patient actions after admission to the health facility, excluding deaths resulting from self-inflicted injuries that were the reason for admission to the health facility.
(4) Care management events, including the following:
(A) A patient death or serious
disability associated with a medication error, including, but not limited to, an error involving the wrong drug, the wrong dose, the wrong patient, the wrong time, the wrong rate, the wrong preparation, or the wrong route of administration, excluding reasonable differences in clinical judgment on drug selection and dose.
(B) A patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.
(C) Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a facility, including events that occur within 42 days postdelivery and excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy.
(D) Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a health facility.
(E) Death or serious disability, including kernicterus, associated with failure to identify and treat hyperbilirubinemia in neonates during the first 28 days of life. For purposes of this subparagraph, “hyperbilirubinemia” means bilirubin levels greater than 30 milligrams per deciliter.
(F) A Stage 3 or 4 ulcer, acquired after admission to a health facility, excluding progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission.
(G) A patient death or serious disability due to spinal manipulative
therapy performed at the health facility.
(5) Environmental events, including the following:
(A) A patient death or serious disability associated with an electric shock while being cared for in a health facility, excluding events involving planned treatments, such as electric countershock.
(B) Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by a toxic substance.
(C) A patient death or serious disability associated with a burn incurred from any source while being cared for in a health facility.
(D) A patient death associated
with a fall while being cared for in a health facility.
(E) A patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health facility.
(6) Criminal events, including the following:
(A) Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider.
(B) The abduction of a patient of any age.
(C) The sexual assault on a patient within or on the grounds of a health facility.
(D) The death or significant
injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility.
(7) An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor.
(c) The facility shall inform the patient or the party responsible for the patient of the adverse event by the time the report is made.
(d) “Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual, or the loss of bodily function, if the impairment or loss lasts more than seven days or is still present at the time of discharge from an inpatient health care facility, or the loss of a body part.
(e) Nothing in this section shall be interpreted to change or otherwise affect hospital reporting requirements regarding reportable diseases or unusual occurrences, as provided in Section 70737 of Title 22 of the California Code of Regulations. The department shall review Section 70737 of Title 22 of the California Code of Regulations requiring hospitals to report “unusual occurrences” and consider amending the section to enhance the clarity and specificity of this hospital reporting requirement.
SEC. 2.
Section 1279.25 is added to the Health and Safety Code, to read:1279.25.
(a) The department shall include a section on the “Complaint Against a Health Care Facility/Provider” form on the department’s internet website and provide means for complaints submitted via mail, fax, or by telephone, for complaints involving a health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250, or subdivision (a) of Section 1250.3, to collect the following information about the affected patient:(1) Age.
(2) Race.
(3) Ethnicity.
(4) Gender
identity.
(5) Sexual orientation.
(6) Primary language spoken.
(7) Disability status.
(8) Income.
(9) Expected payer.
(b) The department shall inform complainants that the information collected pursuant to subdivision (a) is used to ensure that all patients receive the best care possible. The department shall also inform complainants that providing this information is optional and will not affect the department’s investigation process in any way.
(c) When submitting a
complaint, complainants shall be provided with information on how to file a complaint with the Civil Rights Department. The department shall include a statement indicating that referring a complaint is optional and will not affect the department’s investigation process.
(d) For purposes of this section, “complaint” means any oral or written notice to the department, other than a report from the health facility, of an alleged violation of applicable requirements of state or federal law, or an allegation of facts that might constitute a violation of applicable requirements of state or federal law.
SEC. 3.
Section 1279.3 of the Health and Safety Code is amended to read:1279.3.
(a) By January 1, 2015, and until January 1, 2026, the department shall provide information regarding reports of substantiated adverse events pursuant to Section 1279.1 and the outcomes of inspections and investigations conducted pursuant to Section 1279.1, on the department’s internet website and in written form in a manner that is readily accessible to consumers in all parts of California, and that protects patient confidentiality.(b) Commencing January 1, 2026, and annually thereafter, the department shall provide information regarding reports of substantiated adverse events pursuant to
Section 1279.1 and the outcomes of inspections and investigations conducted pursuant to Section 1279.1, including demographic information pursuant to paragraph (2) of subdivision (a) of Section 1279.1, on the department’s internet website and in written form in a manner that is readily accessible to consumers in all parts of California, and that protects patient confidentiality. Nothing in this paragraph shall preclude the department from updating this information on the department’s internet website more frequently than annually.
(c) The information required pursuant to this section shall include, but not be limited to, information regarding each substantiated adverse event, as defined in Section 1279.1, reported to the department, and may include compliance information history. The names of the health care professionals and health care
workers shall not be included in the information released by the department to the public.
SEC. 4.
Section 1279.6 of the Health and Safety Code is amended to read:1279.6.
(a) A health facility, as defined in subdivision (a), (b), (c), or (f) of Section 1250, shall develop, implement, and comply with a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events. The patient safety plan shall be developed by the facility, in consultation with the facility’s various health care professionals.(b) The patient safety plan required pursuant to subdivision (a) shall, at a minimum, provide for the establishment of all of the following:
(1) A patient safety committee or equivalent committee in composition
and function. The committee shall be composed of the facility’s various health care professionals, including, but not limited to, physicians, nurses, pharmacists, and administrators. The committee shall do all of the following:
(A) Review and approve the patient safety plan.
(B) Receive and review reports of patient safety events as defined in subdivision (c).
(C) Monitor implementation of corrective actions for patient safety events.
(D) Make recommendations to eliminate future patient safety events.
(E) Review and revise the patient safety plan, at least once a year, but more often if
necessary, to evaluate and update the plan, and to incorporate advancements in patient safety practices.
(2) A reporting system for patient safety events that allows anyone involved, including, but not limited to, health care practitioners, facility employees, patients, and visitors, to make a report of a patient safety event to the health facility, including anonymous reporting options.
(3) A process for a team of facility staff to conduct analyses, including, but not limited to, root cause analyses of patient safety events. The process shall also include analyses of patient safety events by the sociodemographic factors pursuant to
listed in paragraph (2) of subdivision (a) of Section 1279.1 to identify disparities in these events. The team shall be composed of the facility’s various categories of health care professionals, with the appropriate competencies to conduct the required analyses.
(4) A reporting process that supports and encourages a culture of safety and reporting patient safety events.
(5) A process for providing ongoing patient safety training for facility personnel and health care practitioners.
(6) A process for addressing racism and discrimination, and its impacts on patient health and safety, that includes, but is not limited to:
(A) Monitoring sociodemographic disparities in patient safety events and developing interventions to remedy known disparities.
(B) Encouraging facility staff to report suspected instances of racism and discrimination.
(c) Commencing January 1, 2026, and biannually thereafter, health facilities shall submit patient safety plans to the department’s licensing and certification division.
(1) The department may impose a fine not to exceed five
thousand dollars ($5,000) on health facilities for failure to adopt, update, or submit patient safety plans.
(2) The department may grant a health facility an automatic 60-day extension for submitting biannual patient safety plans.
(d) The department shall make all patient safety plans submitted by health facilities available to the public on its internet website.
(e) For the purposes of this section, patient safety events shall be defined by the patient safety plan and shall include, but not be limited to, all adverse events or potential adverse events as described in Section 1279.1 that are determined to be preventable, and health-care-associated infections (HAI), as defined in the federal Centers for Disease Control
and Prevention’s National Healthcare Safety Network, or its successor, unless the department accepts the recommendation of the Healthcare Associated Infection Advisory Committee, or its successor, that are determined to be preventable.
SEC. 5.
Section 1419 of the Health and Safety Code is amended to read:1419.
(a) The department shall establish a centralized consumer response unit within the Licensing and Certification Division of the department to respond to consumer inquiries and complaints.(b) Upon receipt of consumer inquiries, the unit shall offer assistance to consumers in resolving concerns about the quality of care and the quality of life in long-term health care facilities.
This assistance may include, but shall not be limited to, all of the following:
(1) Offering to provide to consumers education and information about state licensing and federal
certification standards, resident rights, name and address of facilities, referral to other entities as appropriate, and facility compliance history.
(2) Offering to participate in telephone conference calls between consumers and providers to resolve concerns within the scope of the authority of the department. If the inquiry or concern is determined to warrant an onsite investigation, the inquiry or concern shall be considered a complaint and handled pursuant to the complaint investigation process set forth in Section 1420.
(3) Initiating onsite investigations in response to oral or written complaints made pursuant to this section if the unit determines that there is a reasonable basis to believe that the allegations in the complaints describe one or more violations of state law by a long-term
care facility.
(c) Nothing in subdivision (a) or (b) shall preclude the department from taking any or all enforcement actions available under state or federal law.
(d) Any person may request an inspection of any long-term health care facility in accordance with this chapter by giving to the department oral or written notice of an alleged violation of applicable requirements of state law. Any written notice may be signed by the complainant setting forth with reasonable particularity the matters complained of. Oral notice may be made by telephone or personal visit. Any oral complaint shall be reduced to writing by the department. The substance of the complaint shall be provided to the licensee no earlier than at the commencement of the inspection.
(e) The department shall include a section for complaints to collect the following information of the affected consumer:
(1) Age.
(2) Race.
(3) Ethnicity.
(4) Gender identity.
(5) Sexual orientation.
(6) Primary language spoken.
(7) Disability status.
(8) Income.
(9) Expected payer.
(f) The section shall include a statement indicating that the information is used to ensure that all patients receive the best care possible, and that providing this information is optional and will not affect the department’s investigation process in any way.
(g) When submitting a complaint, complainants shall be provided with information on how to file a complaint with the Civil Rights Department. The department shall state that filing a complaint is optional and will not affect the department’s investigation process.
(h) Neither the substance of the complaint provided the licensee nor any copy of the complaint or
record published, released, or otherwise made available to the licensee shall disclose the name of any individual complainant or other person mentioned in the complaint, except the name or names of any duly authorized officer, employee, or agent of the state department conducting the investigation or inspection pursuant to this chapter, unless the complainant specifically requests the release of the name or names or the matter results in a judicial proceeding.
