Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 114 - Rules Governing the Reporting of Sentinel Events
Section 144-114-1 - Definitions

Universal Citation: 10 ME Code Rules ยง 144-114-1

Current through 2024-38, September 18, 2024

As used in these rules, unless the context otherwise indicates, the following terms have the following meanings.

1.1 Adverse. "Adverse" describes a consequence of care that results in an undesired outcome. It does not address preventability.

1.2 Associated with."Associated with" means that it is reasonable to initially assume that the adverse event was due to the referenced course of care; further investigation or root cause analysis of the unplanned event may be needed to confirm or refute the presumed relationship.

1.3 Disability. "Disability" means a physical or mental impairment that substantially limits one or more of the major life activities of an individual. (See Americans with Disabilities Act).

1.4 Discovered. For the purposes of these rules, "discovered" means the point at which one becomes aware of a sentinel event.

1.5 Division. "Division" means the Department of Health and Human Services (DHHS), Division of Licensing and Regulatory Services (DLRS).

1.6 Event."Event" means a discrete, auditable, and clearly defined occurrence.

1.7 Final Agency Action."Final Agency Action" means a decision by DHHS which affects the legal rights, duties or privileges of specific persons, which is dispositive of all issues, legal and factual, and for which no further recourse, appeal or review is provided within DHHS, 5 M.R.S.A. §8002.

1.8 Healthcare Facility. "Healthcare facility" or "facility" means a state institution as defined by 34-B M.R.S.A. Chapter 1 or a healthcare facility licensed by the division, excluding a facility licensed as a nursing facility by 22 M.R.S.A. Chapter 405 or licensed as an assisted housing program by 22 M.R.S.A. Chapter 1664. "Healthcare facility" includes:

1.8.1 A general and specialty hospital licensed pursuant to 22 M.R.S.A. Chapter 405.

1.8.2 An ambulatory surgical facility licensed pursuant to 22 M.R.S.A. §1812-E.

1.8.3 An end-stage renal disease (ESRD) facility licensed pursuant to 22 M.R.S.A. Chapter 412. These rules do not apply to home dialysis. Home dialysis means dialysis performed at home by an ESRD patient or caregiver who has completed an appropriate course of training.

1.8.4 An intermediate care facility for individuals who are intellectually disabled (ICF/IID) licensed pursuant to 22 M.R.S.A. Chapter405.

1.9 Immediate jeopardy."Immediate jeopardy" means a situation in which the provider's noncompliance with one or more conditions of participation in the federal Medicare program has caused, or is likely to cause, serious injury, harm or impairment to or death of a patient.

1.10 Injury. "Injury," as used in these rules has a broad meaning. It includes physical or mental damage that substantially limits one or more of the major life activities of an individual in the short term, which may become a disability if extended long term. Further, injury includes a substantial change in the patient's long-term risk status such that care or monitoring, based on accepted national standards, is required that was not required before the event.

1.11 Inter-facility transfer. "Inter-facility transfer" means any transfer, after initial assessment and stabilization of the patient, from, and to, a healthcare facility, or within the same health system, including but not limited to:

1.11.1 Hospital to hospital.

1.11.2 Clinic to hospital.

1.11.3 Hospital to rehabilitation facility.

1.11.4 Ambulatory surgical facility to hospital.

1.11.5 Hospital to long term care.

1.11.6 ESRD to hospital.

1.12 Major Life Activities. For the purposes of these rules, "major life activities" means functions, including but not limited to, caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, working and the operation of a major bodily function. Major bodily functions include but are not limited to functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions. (see the federal Americans with Disabilities Act).

1.13 Major Permanent Loss of Function. "Major permanent loss of function" meanssensory, motor, physiological or intellectual impairment that was not present at the time of admission and

1.13.1 requires continued treatment or

1.13.2 imposes persistent major restrictions in activities of daily living; and

1.13.3 is unrelated to the natural course of the patient's illness or underlying condition or proper treatment of that illness or underlying condition in a health care facility.

1.14 Near Miss. "Near miss" means an event or situation that did not produce patient injury, but only because of chance, which may include, but is not limited to, robustness of the patient or a fortuitous, timely intervention. See 22 M.R.S.A. §8752(3-A).

1.15 Neonate. "Neonate" is a newborn less than 28 days of age.

1.16 Patient. "Patient" means a person who is a recipient of healthcare. A person becomes a patient at the point that they are being "cared for" in the facility. Being "cared for" begins when they are first engaged by a member of the care team, e.g. assessment by the triage nurse in the E.D., walking with the phlebotomist to the lab for a lab draw. A patient is no longer considered a patient at the point that they are no longer under the care of a member of the care team, e.g. the nursing assistant has safely assisted the patient to the car from an inpatient stay; the ambulating patient that does not need assistance leaves the radiology department following an outpatient test.

1.17 Perinatal Period. "Perinatal period" means the 28th week of gestation to the 28th day of life.

1.18 [Reserved]

1.19 Pregnancy, Low Risk. "Low-risk pregnancy" refers to 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.

1.20 Preventable. "Preventable" describes an event that could have been anticipated and prepared for, but that occurs because of an error or other system failure.

1.21 Root Cause Analysis (RCA). "Root cause analysis" means a structured process for identifying the causal or contributing factors underlying adverse events. The RCA follows a predefined protocol for identifying the specific factors in causal categories.

1.22 Sentinel Event. A "sentinel event" means:

1.22.1 Serious and preventable events described in Appendix A of these rules. See 22 M.R.S.A. §8752(4-A)(D);

1.22.2 An unanticipated death or patient transfer to another healthcare facility, unrelated to the natural course of the patient's illness or underlying condition or proper treatment of that illness or underlying condition in a healthcare facility;

1.22.3 A major permanent loss of function unrelated to the natural course of the patient's illness or underlying condition or proper treatment of that illness orunderlying condition in a healthcare facility that is present at the time of the discharge of the patient;
1.22.3.1 For the purposes of ESRDs, the term "discharge" means within 48 hours of a treatment.

1.22.3.2 If within 14 days of discharge from a healthcare facility, evidence is discovered that the major loss of function was not permanent, the facility must submit the department-approved Functional Evidence form with supporting documentation to the SET, and the healthcare facility is not required to submit the root cause analysis (RCA) report required in Section 4 of these rules. See 22 M.R.S.A. §8752(4-A)(B).

1.22.4 An unanticipated death or major permanent loss of function that occurs within 48 hours of treatment or procedure in a healthcare facility that is unrelated to the natural course of the patient's illness or underlying condition or proper treatment of that illness or underlying condition;

1.22.5 The suicide of a patient that occurs within 48 hours of discharge from a healthcare facility;

1.22.6 An unanticipated perinatal death or major permanent loss of function in an infant, with a birth weight over 2,500 grams that is unrelated to the natural course of the infant's or mother's illness or underlying condition or unrelated to the proper treatment of the infant's or mother's illness or underlying condition in a healthcare facility.

1.23 Sentinel Events Team.The Sentinel Events Team (SET), a unit of the Division of Licensing and Regulatory Services (DLRS), is assigned the responsibility to implement these rules.

1.24 Serious. "Serious" describes an event that can result in death, loss of a body part, disability,loss of bodily function, or require major intervention for correction (e.g., higher level of care, surgery).

1.25 Sexual Assault. "Sexual assault" as a reportable event means nonconsensual sexual contact that is not part of medically necessary health care involving a patient and another patient, staff member, or other perpetrator while being treated or on the premises of the healthcare facility, including oral, vaginal or anal penetration or fondling of the patient's sex organ(s) by another individual's hand, sex organ or object.

1.26 [Reserved]

1.27 Surgery."Surgery" is 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 (biopsy, excision, and deep cryotherapy for malignant lesions) to vaginal birth or Caesarian delivery to extensive multiorgan transplantation. It does not include use of such things as otoscopes and drawing blood.

1.27.1 Surgery begins, regardless of setting, at point of surgical incision, tissue puncture, or insertion of instrument into tissues, cavities, or organs.

1.27.2 Surgery endsafter all incisions or procedural access routes have been closed in their entirety, device(s) 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/procedure room.

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