Mandatory Reporting

California Mandatory Reporting

Article 11.  Adverse Event Reporting Requirements

§ 70970. Applicability.

§ 70971. Definitions.

§ 70972. Adverse Event Reporting Requirements.

§ 70973. Adverse Event Investigation.

§ 70974. Adverse Events—Policies and Procedures.

70970. Applicability.

(a) This article applies to reportable adverse events in general acute care hospitals and special hospitals pursuant to subdivision (a) of

Health and Safety Code section 1279.1.

(b) For the purposes of this Article:

(1) General acute care hospitals and special hospitals shall be called “hospital” and include any outpatient services on the hospital's license.

(2) The “hospital” does not include a distinct part operated pursuant to section 70503 or 70627.

Health and Safety Code - HSC

DIVISION 2. LICENSING PROVISIONS [1200 - 1796.70]  ( Division 2 enacted by Stats. 1939, Ch. 60. )

CHAPTER 2. Health Facilities [1250 - 1339.59]  ( Chapter 2 repealed and added by Stats. 1973, Ch. 1202. )

ARTICLE 3. Regulations [1275 - 1289.5]  ( Article 3 added by Stats. 1973, Ch. 1202. )
 

1279.1.  

(a) 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.

(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 decision making 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.

70737 is program flex

 70971. Definitions.



(a) As used in Health and Safety Code sections 1279.1, 1279.2, 1279.6 and this article:

(1) “A patient death or serious disability associated with the use of restraints” means a patient death or serious disability associated with the use of physical restraints.

(2) “Adverse event” shall have the meaning defined in Health and Safety Code section 1279.1(b)(1-7).

(3) “Biologic” means medical products made from a variety of natural sources (human, animal, or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biologics include vaccines, blood and blood products, gene therapies, and allergenic extracts.

(4) “Countershock” means an electric shock intended to restore normal rhythm of the heart (i.e., cardioversion and/or defibrillation).

(5) “Culture of safety” means the actions and behaviors in the hospital that are rewarded, supported, expected, and accepted in the hospital as it relates to patient safety.

(6) “Decision-making capacity” means the ability to understand information relevant to a decision and the ability to appreciate the reasonably foreseeable consequences of a decision (or lack of a decision).

(7) “Detect” means the discovery of an adverse event, or the reasonable belief of a discovery of an adverse event, by a hospital, its personnel, or its agents. An adverse event shall be treated as detected as of the first business day on which such adverse event is known to the hospital, or by exercising reasonable diligence would have been known to the hospital. A hospital shall be deemed to have knowledge of an adverse event if such an adverse event is known, or by exercising reasonable diligence would have been known, to any person other than the person committing the adverse event, who is the personnel or agent of the hospital.

(8) “Device” means a medical instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related medical product or device, including a component part or accessory that is recognized in the United States Pharmacopeia and the National Formulary (USP-NF) or any supplement, intended for use in the diagnosis of disease or other conditions, or in the care, mitigation, treatment, or prevention of disease, in humans or other animals; or intended to affect the structure or any function of the body of humans or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

(9) “Infant” means a child under the age of one year.

(10) “Low-risk pregnancy” means the pregnancy of a woman aged 18-39, with no previous diagnosis of essential hypertension, renal disease, collagen-vascular disease, liver disease, cardiovascular disease, placenta previa, multiple gestation, intrauterine growth retardation, smoking, pregnancy-induced hypertension, premature rupture of membranes, or other previously documented condition that poses a high risk of poor pregnancy outcome.

(11) “Major life activity” means any of the following:

(A) Caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working; or

(B) A major bodily function, including functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions.

(12) “Medication error” means any preventable incident that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional. Such incidents may be related to professional practice, products, procedures, and systems, including prescribing, order communication, product labeling, packaging and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.

(13) “Nationally recognized survey tool” means a valid and reliable survey tool identified by the Agency for Healthcare Research and Quality (AHRQ), or another survey tool which raises awareness of patient safety, assesses status of culture of safety, evaluates impact of patient safety interventions, and identifies strengths and areas for culture of safety improvement.

(14) “Normal, healthy patient” means a person without a systemic disease.

(15) “Party responsible for the patient” means an adult who is expressly authorized to act on the patient's behalf within the scope and duration of the authority granted and is documented in the patient's medical record.

(16) “Patient safety event” shall have the meaning defined in Health and Safety Code section 1279.6(c).

(17) “Retention of a foreign object” refers to an item introduced into the body during a surgical or other invasive procedure, without removal prior to the end of the surgery or procedure, which the surgeon or other practitioner did not intend to leave in the body. This definition excludes (a) objects intentionally implanted as part of a planned intervention, (b) objects present prior to the surgery or other procedure that are intentionally left in place, (c) objects not present prior to the surgery or other procedure that are intentionally left in place when the risk of removal exceeds the risk of leaving the object in place (e.g., microneedles, broken screws), and the physician/surgeon documents the risk of removal.

(18) “Root cause analysis” means a range of approaches, tools, and techniques used to identify causes of complex problems. In addition, root cause analysis identifies the circumstances of the adverse event, including a timeline, to confirm or refute a presumed preventable adverse event.

(19) “Serious bodily harm” means injuries creating substantial risk of death or serious, permanent disfigurement or prolonged loss or impairment of the function of any body part or organ.

(20) “Significant injury” means an injury involving physical pain, substantial risk of death, or prolonged loss or impairment of function of a body member, organ, or of mental faculty, or requiring medical intervention, including, but not limited to, hospitalization, surgery, or physical rehabilitation.

(21) “Stage 2 pressure ulcer” means a partial-thickness loss of skin with exposed dermis. The wound bed is viable, pink or red, moist, and may also present as an intact or ruptured serum-filled blister. Adipose (fat) is not visible and deeper tissues are not visible. Granulation tissue, slough, and eschar are not present. These ulcers commonly result from adverse microclimate and shear in the skin over the pelvis and shear in the heel. This stage should not be used to describe moisture-associated skin damage (MASD) including incontinence-associated dermatitis (IAD), intertriginous dermatitis (ITD), medical adhesive related skin injury (MARSI), or traumatic wounds (skin tears, burns, abrasions).

(22) “Stage 3 pressure ulcer” means a full-thickness loss of skin, in which adipose (fat) is visible in the ulcer and granulation tissue and epibole (rolled wound edges) are often present. Slough or eschar or both may be visible. The depth of tissue damage varies by anatomical location; areas of significant adiposity can develop deep wounds. Undermining and tunneling may occur. Fascia, muscle, tendon, ligament, cartilage, or bone are not exposed. If slough or eschar obscures the extent of tissue loss, this is an Unstageable Pressure Ulcer.

(23) “Stage 4 pressure ulcer” means a full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage, or bone in the ulcer. Slough or eschar or both may be visible. Epibole (rolled wound edges), undermining, or tunneling often occur. Depth varies by anatomical location. If slough or eschar obscures the extent of tissue loss, this is an Unstageable Pressure Ulcer.

(24) “Substantiated” means the Department determined the reported incident met the definition of adverse event at Health and Safety Code section 1279.1(b)(1-7).

(25) “Surgery” means an invasive operative procedure in which skin or mucous membranes and connective tissue is incised or the procedure is carried out using an instrument that is introduced through a natural body orifice. It includes minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar. Surgeries include a range of procedures from minimally invasive dermatological procedures (e.g., biopsy, excision, and deep cryotherapy for malignant lesions) to vaginal birth or Caesarian delivery to extensive multi-organ transplantation. It does not include use of medical devices such as otoscopes and procedures such as drawing blood.

(26) “Surgery begins” at the point of surgical incision, tissue puncture, or insertion of an instrument into tissues, cavities, or organs.

(27) “Surgery ends” after all incisions or procedural access routes have been closed in their entirety, devices such as probes or instruments have been removed, and, if relevant, final surgical counts confirming accuracy of counts and resolving any discrepancies have concluded and the patient has been taken from the operating or procedure room. A vaginal birth ends after the delivery of the fetus and the placenta, and all surgical repairs have been completed.

(28) “Suspected deep tissue pressure ulcer” means an intact or non-intact skin with localized area of persistent non-blanchable deep red, maroon, or purple discoloration or epidermal separation revealing a dark wound bed or blood filled blister. Pain and temperature change often precede skin color changes. Discoloration may appear differently in darkly pigmented skin. This injury results from intense and/or prolonged pressure and shear forces at the bone-muscle interface. The wound may evolve rapidly to reveal the actual extent of tissue injury, or may resolve without tissue loss. If necrotic tissue, subcutaneous tissue, granulation tissue, fascia, muscle, or other underlying structures are visible, this indicates a full thickness pressure injury (Unstageable, Stage 3, or Stage 4). Do not use deep tissue pressure injury to describe vascular, traumatic, neuropathic, or dermatologic conditions.

(29) “Unstageable pressure ulcer” means a full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because it is obscured by slough or eschar. If slough or eschar is removed, a Stage 3 or Stage 4 pressure ulcer will be revealed.

(30) “Unsubstantiated” means the Department determined the reported incident did not meet the definition of adverse event in Health and Safety Code section 1279.1(b)(1-7).

(31) “Wrong person” as used pursuant to Health and Safety Code section 1279.1(b)(3)(A), means a person without a “right to custody” as that term is defined under California Penal Code Section 277.

70972. Adverse Event Reporting Requirements.

(a) Pursuant to Health and Safety Code sections 1279.1 and 1279.3, adverse events shall be reported by the hospital through a secure internet website maintained by the Department pursuant to the following timelines:

(1) Adverse events that are ongoing urgent or emergent, threatening the welfare, health, or safety of patients, personnel, or visitors, shall be reported within 24 hours after the adverse event is detected.

(2) Sexual assault of a patient, including allegations of sexual assault of a patient, provided for under Health and Safety Code section 1279.1(b)(6)(C), shall be reported within 24 hours after detection.

(3) All other adverse events shall be reported to the Department no later than five (5) calendar days after the adverse event is detected.

(b) When reporting adverse events, the hospital shall provide to the Department the following information:

(1) Name and address of the hospital.

(2) Location and service area where the adverse event occurred.

(3) Date and time the adverse event occurred and was detected, if known.

(4) Name of each individual affected by the adverse event and any patients, personnel, and visitors involved or a witness to the adverse event, if known.

(5) Description of the circumstances surrounding the adverse event, including the nature and extent of injury or harm.

(6) If an individual affected by the adverse event is a patient, the date the patient, or the party responsible for the patient, was informed of the adverse event. This date shall not be later than the date the hospital reported the adverse event to the Department.

(7) Name, title, area code, and telephone number of a hospital representative for the Department to contact for additional information.

(8) Hospital's immediate corrective or mitigating action in response to the adverse event.

(9) Any additional information as it becomes available regarding the adverse event.

(c) In the event the Department's secure internet website is not operational, the hospital shall report an adverse event to the Department by email or telephone.

70973. Adverse Event Investigation.

(a) The hospital shall provide the requisite information, as outlined in section 70972, necessary for the Department to determine if an adverse event is substantiated or unsubstantiated, pursuant to the following process:

(1) If the reported adverse event or complaint is determined by the Department to be an ongoing threat of imminent danger of death or serious bodily harm, the hospital shall be subject to an

onsite investigation, initiated within 48 hours or two (2) business days of receipt of the report or complaint, whichever is greater.

(2) If the Department determines there is no ongoing threat of imminent danger of death or serious bodily harm, the hospital shall be subject to one or both of the following:

(A) An onsite inspection.

(B) An offsite investigation that includes but is not limited to interviews and records reviews.

 70974. Adverse Events--Policies and Procedures.

(a) Each hospital shall develop, implement, maintain, and comply with policies and procedures for a written patient safety plan, pursuant to Health and Safety Code section 1279.6, that specifies systemic processes for:

(1) Internally reporting preventable patient safety events, as defined in Health and Safety Code section 1279.6 (c).

(2) Documenting reportable patient safety events.

(3) Conducting a root cause analysis for the patient safety event. A root cause analysis, or any other investigation, shall not change reporting requirements regarding reportable diseases or unusual occurrences as provided in Section 70737.



(4) Assessing the hospital's culture of safety at least every 24 months using a nationally recognized survey tool.

Never Events

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