California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 1 - General Acute Care Hospitals › Article 11 - Adverse Event Reporting Requirements › Section 70971 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.