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 › Appendix 144-114-A - National Quality Forum(NQF) 2011 List of Serious Reportable Events

Current through 2024-29, July 17, 2024
EVENT, SPECIFICATIONS AND IMPLEMENTATION
				  GUIDANCE
The following table presents the specifications for the
				  proposed consensus standards. The information presented represents an update of
				  the 2006 report with revision and additions made by the Serious Reportable
				  Events Steering Committee utilizing NQF Member and public submissions and
				  consultation with experts in the various fields. These proposed voluntary
				  consensus standards are the intellectual property of the National Quality Forum
				  and as such they are open source, fully accessible, and disclosed.
Definitions of key terms are included in the Glossary
				  (Appendix B) and, where the terms are used in the event description or
				  additional specifications are considered part of the specifications of the
				  events.
Implementation Guidance is not proposed for endorsement. It
				  amplifies statements in the Event and Additional Specifications, which are
				  proposed for endorsement, with examples and explanations based on experience of
				  those organizations/entities that have implemented event reporting as well as
				  recommendations of the NQF Serious Reportable Events Steering Committee. It
				  does not purport to be either comprehensive or even across the events and is
				  not a requirement of either.
http://www.qualityforum.org/Publications/2011/12/Serious_Reportable_Events_in_Healthcare_2011.aspx
1.SURGICAL OR INVASIVE PROCEDURE
							 EVENTS
EVENT
ADDITIONAL SPECIFICATIONS
IMPLEMENTATION GUIDANCE
A. Surgery or other invasive procedure performed on
							 the wrong site Applicable settings: . Hospitals . Outpatient/Office-based
							 Surgery Centers . Ambulatory Practice Settings/Office-based Practices .
							 Long-term Care/Skilled Nursing Facilities
Defined as any surgery or other invasive procedure
							 performed on a body part or site that is not consistent with the correctly
							 documented informed consent for that patient. Surgery or other invasive
							 procedure includes, but is not limited to, endoscopies, lens implants, lesion
							 removal, injection into joints. Excludes emergent situations that occur in the
							 course of surgery or other invasive procedure and/or whose exigency precludes
							 obtaining informed consent.
It should be noted that a correctly documented
							 informed consent for patients whose procedures will not be carried out in an
							 operating room may not involve a "surgical consent form"; however, it does
							 require informed consent be documented in the patient record. Although an
							 incorrectly placed surgical mark could result in surgery being performed on the
							 wrong body part, surgery does not begin at time the surgical mark is made on
							 the patient. Placing a mark on the wrong body part or site does not in itself
							 constitute wrong site surgery. Wrong site surgery or invasive procedure,
							 corrected during the procedure, is still a wrong site procedure if the surgery/
							 procedure had begun, based on the definition in glossary. This event is
							 intended to capture instances of: . surgery or other invasive procedure on the
							 right body part but on the wrong location/site on the body; e.g. left/right
							 (appendages/organs), wrong digit, level (spine), stent placed in wrong iliac
							 artery, steroid injection into wrong knee, biopsy of wrong mole, burr hole on
							 wrong side of skull;
. delivery of fluoroscopy or radiotherapy to the wrong
							 region of the body; . use of incorrectly placed vascular catheters; . use of
							 incorrectly placed tubes (for example, feeding tubes placed in the lung or
							 ventilation tubes passed into the esophagus). This event is not intended to
							 capture: . changes in plan upon entry into the patient with discovery of
							 pathology in close proximity to the intended place where risk of a second
							 surgery or procedure outweighs benefit of patient consultation, or unusual
							 physical configuration (for example adhesions.spine level/extra vertebrae).
B. Surgery or other invasive procedure performed on
							 the wrong patient Applicable settings: . Hospitals . Outpatient/Office-based
							 Surgery Centers . Ambulatory Practice Settings/ Office-based Practices .
							 Long-term Care/Skilled Nursing Facilities
Defined as any surgery or invasive procedure on a
							 patient that is not consistent with the correctly documented informed consent
							 for that patient. Surgery or other invasive procedure includes, but is not
							 limited to, endoscopies, lens implants, lesion removal, injection into joints.
It should be noted that a correctly documented
							 informed consent for patients whose procedures will not be carried out in an
							 operating room may not involve a "surgical consent form"; however, it does
							 require informed consent be documented in the patient record. This event is
							 intended to capture: . surgical procedures (whether ornot completed) initiated
							 on one patient intended for a different patient. Use of accepted patient
							 identification procedures is key to avoiding such events.
C. Wrong surgical or other invasive procedure
							 performed on a patient Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facilities
Defined as any surgical or other invasive procedure
							 performed on a patient that is not consistent with the correctly documented
							 informed consent for that patient. Surgery or other invasive procedure
							 includes, but is not limited to, endoscopies, lens implants, lesion removal,
							 injection into joints. Excludes emergent situations that occur in the course of
							 surgery or other invasive procedures and/or whose exigency precludes obtaining
							 informed consent.
It should be noted that a correctly documented
							 informed consent for patients whose procedures will not be carried out in an
							 operating room may not involve a "surgical consent form"; however, it does
							 require informed consent be documented in the patient record. This event is
							 intended to capture: . insertion of the wrong medical implant into the correct
							 surgical site. This event is not intended to capture: . changes in plan upon
							 entry into the patient with discovery of pathology in close proximity to the
							 intended place where risk of a second surgery/ procedure outweighs benefit of
							 patient consultation, or unusual physical configuration (for example adhesions,
							 spine level/extra vertebrae).
D. Unintended retention of a foreign object in a
							 patient after surgery or other invasive procedure Applicable settings: .
							 Hospitals . Outpatient/Office-based Surgery Centers . Ambulatory Practice
							 Settings/ Office-based Practices . Long-term Care/Skilled Nursing Facilities
Includes medical or surgical items intentionally
							 placed by providers) that are unintentionally left in place. Excludes a)
							 objects present prior to surgery or other invasive procedure that are
							 intentionally left in place; b) objects intentionally implanted as part of a
							 planned intervention; and c) objects not present prior to surgery/procedure
							 that are intentionally left in when the risk of removal exceeds the risk of
							 retention (such as microneedles, broken screws).
This event is intended to capture: . occurrences of
							 unintended retention of objects at any point after the surgery/procedure ends
							 regardless of setting (post anesthesia recovery unit, surgical suite, emergency
							 department, patient bedside) and regardless of whether the object is to be
							 removed after discovery; . unintentionally retained objects (including such
							 things as wound packing material, sponges, catheter tips, trocars, guide wires)
							 in all applicable settings.
E. Intraoperative or immediately postoperative/
							 postprocedure death in an ASA Class 1 patient Applicable settings: . Hospitals
							 . Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices
Includes all ASA Class 1 patient deaths in situations
							 where anesthesia was administered; the planned surgical procedure may or may
							 not have been carried out. Immediately post-operative means within 24 hours
							 after surgery or other invasive procedure was completedor after
							 administrationof anesthesia (if surgery/procedure not completed).
This event is intended to capture: . ASA Class 1
							 patient death associated with the administration of anesthesia whether or not
							 the planned surgical procedure was carried out.
2.PR0DUCT OR DEVICE EVENTS
EVENT
ADDITIONAL SPECIFICATIONS
IMPLEMENTATION GUIDANCE
A. Patient death or serious injury associated with the
							 use of contaminated drugs, devices, or biologies provided by the healthcare
							 setting Applicable settings: . Hospitals . Outpatient/Office-based Surgery
							 Centers . Ambulatory Practice Settings/ Office-based Practices . Long-term
							 Care/Skilled Nursing Facilities
Includes contaminants in drugs, devices, or biologies
							 regardless of the source of contamination and/or product. Includes threat of
							 disease that changes patient's risk status for life requiring medical
							 monitoring not needed before the event
This event is intended to capture: . contaminations
							 that can be seen with the naked eye or with use of detection mechanisms in
							 general use. These contaminations are to be reported at such time as they
							 become known to the provider or healthcare organization. Contaminants may be
							 physical, chemical, or biological in nature. Not all contaminations can be seen
							 with the naked eye (e.g., hepatitis and HIV) or readily detected using
							 generally available or more specialized testing mechanisms (e.g., cultures,
							 nucleic acid testing, mass spectrometry, and tests that signal changes in pH or
							 glucose levels). Contamination that is inferred and changes risk status for
							 life (e.g., consider a syringe or needle contaminated once it has been used to
							 administer medication to a patient by injection or via connection to a
							 patient's intravenous infusion bag or administration set). This event is
							 intended to capture: . administration of contaminated vaccine or medication
							 (e.g., intramuscular antibiotic); . serious infection from contaminated drug or
							 device used in surgery or an invasive procedure (e.g., a scalpel); .
							 occurrences related to use of improperly cleaned or maintained device.
B. Patient death or serious injury associated with the
							 use or function of a device in patient care, in which the device is used or
							 functions other than as intended Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facilities
Includes, but is not limited to, catheters, drainsand
							 other specialized tubes, infusion pumps, ventilators, and procedural and
							 monitoring equipment.
This event is intended to capture: . occurrences
							 whether or not the use is intended or described by the device manufacturers'
							 literature.
C. Patient death or serious injury associated with
							 intravascular air embolism that occurs while being cared for in a healthcare
							 setting Applicable settings: . Hospitals . Outpatient/Office-based Surgery
							 Centers, . Long-term Care/Skilled . Nursing Facilities
Excludes death or serious injury associated with
							 neurosurgical procedures known to present a high risk of intravascular air
							 embolism.
This event is intended to capture: . high-risk
							 procedures, other than neurosurgical procedures, that include, but are not
							 limited to, procedures involving the head and neck, vaginal delivery and
							 caesarean section, spinal instrumentation procedures and liver transplantation;
							 . low-risk procedures including those related to lines placed for infusion of
							 fluids in vascular space.
3.PATIENT PROTECTION EVENTS
EVENT
ADDITIONAL SPECIFICATIONS
IMPLEMENTATION GUIDANCE
A. Discharge or release of a patient/resident of any
							 age, who is unable to make decisions, to other than an authorized person.
							 Applicable settings: . Hospitals . Outpatient/Office-based Surgery Centers .
							 Ambulatory Practice Settings/ Office-based Practices . Long-term Care/Skilled
							 Nursing Facilities
The terms "authorized" and "decisionmaking capacity"
							 are defined in the glossary. Release to"other than an authorized person"
							 includes removing the patient/resident without specific notification and
							 approval by staff even when the person is otherwise authorized. Examples of
							 individuals who do not have decision-making capacity include: newborns, minors,
							 adults with Alzheimer's. Individual health care organizations or other relevant
							 jurisdictional authorities may have specific requirements for assessing
							 decision-making capacity.
B. Patient death or serious injury associated with
							 patient elopement (disappearance). Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facilities
Includes events that occur after the individual
							 presents him/herself for care in a healthcare setting. Excludes events
							 involving competent adults with decisionmaking capacity who leave against
							 medical advice or voluntarily leave without being seen.
The term "elopement" and "competent" adult should be
							 interpreted in accordance with prevailing legal standards in applicable
							 jurisdictions. Of note, an assessment that identifies patients at 'risk' of
							 elopement or a chief complaint and findings of risk accompanied by
							 organizationally defined measures to be taken when risk is identified could be
							 useful in both prevention and event analysis. This is not intended to capture:
							 . death or serious injury that occurs (after the patient is located) due to
							 circumstances unrelated to the elopement.
C. Patient suicide, attempted suicide, or self-harm
							 that results in serious injury, while being cared for in a healthcare setting
							 Applicable settings: . Hospitals . Outpatient/Office-based Surgery Centers .
							 Ambulatory Practice Settings/ Office-based Practices . Long-term Care/Skilled
							 Nursing Facilities
Includes events that result from patient actions after
							 they present themselves for care in a healthcare setting. Excludes deaths
							 resulting from self-inflicted injuries that were the reason for
							 admission/presentation to the healthcare facility.
This event is not intended to capture patient suicide
							 or attempted suicide when the patient is not physically present in the
							 "healthcare setting "as defined in the glossary.
4.CARE MANAGEMENT EVENTS
EVENT
ADDITIONAL SPECIFICATIONS
IMPLEMENTATION GUIDANCE
A. Patient death or serious injury associated with a
							 medication error (e.g., errors involving the wrong drug, wrong dose, wrong
							 patient, wrong time, wrong rate, wrong preparation, or wrong route of
							 administration) Applicable settings: . Hospitals . Outpatient/Office-based
							 Surgery Centers . Ambulatory Practice Settings/ Office-based Practices .
							 Long-term Care/Skilled Nursing Facilities
Excludes reasonable differences in clinical judgment
							 on drug selection and dose. Includes, but is not limited to, death or serious
							 injury associated with a) over- or under-dosing; b) administration of a
							 medication to which a patient has a known allergy or serious contraindication,
							 c) drug-drug interactions for which there is known potential for death or
							 serious injury, d) improper use of single-dose/single-use and multi-dose
							 medication vials and containers leading to death or serious injury as a result
							 of dose adjustment problems.
This event is intended to capture: . the most serious
							 medication errors including occurrences in which a patient receives a
							 medication for which there is a contraindication or a patient, known to have
							 serious allergies to specific medications/ agents, receives those medications/
							 agents, resulting in serious injury or death.These events may occur as a result
							 of failure to collect information about contraindications or allergies, failure
							 to review such information available in information systems, failure of the
							 organization to assure availability of such information and prominently display
							 such information within information systems, or other system failures that are
							 determined through investigation to be cause of the adverse event. .
							 occurrences in which a patient dies or suffers serious injury as a result of
							 failure to administer a prescribed medication; . occurrences in which a patient
							 is administered an over- or under-dose of a medication including insulin,
							 heparin, and any other high alert medication including but not limited to
							 medications listed on the Institute for Safe Medication Practices "High Alert
							 Medication List"; . occurrences in which a patient dies orsuffers serious
							 injury as a result of wrong administration technique. This event is not
							 intended to capture: . patient death or serious injury associated with
							 allergies that could not reasonably have been known or discerned in advance of
							 the event.
B. Patient death or serious injury associated with
							 unsafe administration of blood products Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facility
Unsafe administration includes, but is not limited to,
							 hemolytic reactions and administering a) blood or blood products to the wrong
							 patient; b) the wrong type; or c) blood or blood products that have been
							 improperly stored or handled. This event is not intended to capture : . patient
							 death or serious injury associated with organ rejection other than those
							 attributable to a hyperacute hemolytic reaction . patient death or injury when
							 cause is not detectable by ABO/HLA matching.
C. Maternal death or serious injury associated with
							 labor or delivery in a low-risk pregnancy while being cared for in a healthcare
							 setting Applicable settings: . Hospitals . Outpatient/Office-based Surgery
							 Centers
Includes events that occur within 42 days
							 post-delivery. Excludes deaths from pulmonary or amniotic fluid embolism, acute
							 fatty liver of pregnancy, or cardiomyopathy.
This event is not intended to create a new obligation.
							 The organization's obligation is to report the event when made aware of the
							 maternal death or serious injury either by readmittance or by the patient's
							 family.
D. Death or serious injury of a neonate associated
							 with labor or delivery in a low-risk pregnancy Applicable settings: . Hospitals
							 . Outpatient/Office-based Surgery Centers
Includes, for the office-based surgery, birthing
							 center or "home" setting, unplanned admission to an inpatient setting within 24
							 hours of delivery
Unplanned admission to other than the birth setting
							 should be verified with the identified birth setting.
E. Patient death or serious injury associated with a
							 fall while being cared for in a healthcare setting Applicable settings: .
							 Hospitals . Outpatient/Office-based Surgery Centers . Ambulatory Practice
							 Settings/ Office-based Practices . Long-term Care/Skilled Nursing Facilities
Includes but is not limited to fractures, head
							 injuries, andintracranial hemorrhage
Of note, an assessment that identifies patients at
							 'risk' of fall, findings of risk accompanied by organizationally defined
							 measures to be taken when risk is identified could be useful in both prevention
							 and event analysis.
F. Any Stage 3, Stage 4, and unstageable pressure
							 ulcers acquired after admission/ presentation to a healthcaresetting Applicable
							 settings: . Hospitals . Outpatient/Office-based Surgery Centers . Long-term
							 Care/ Skilled Nursing Facilities
Excludes progression from Stage 2 to Stage 3 if Stage
							 2 was recognized upon admission and excludes pressure ulcers that develop in
							 areas where deep tissue injury is documented as present on
							 admission/presentation.
Although this event could occur in the ambulatory
							 surgery environment based on patient condition and surgery time, it will be
							 difficult to discern. Pre- and post- skin assessment will be key.
G. Artificial insemination with the wrong donor sperm
							 or wrong egg Applicable settings: . Hospitals . Outpatient/Office-based Surgery
							 Centers . Ambulatory Practice Settings/ Office-based Practices
The organization's obligation is to report the event
							 when made aware of the occurrence.
H. Patient death or serious injury resulting from the
							 irretrievable loss of an irreplaceable biological specimen. Applicable
							 settings: . Hospitals . Outpatient/Office-based Surgery Centers . Ambulatory
							 Practice Settings/ Office-based Practices . Long-term Care/Skilled Nursing
							 Facilities
Includes events where specimens are misidentified,
							 where another procedure cannot be done to produce a specimen Includes
							 progression of an undiagnosed disease or threat of disease that changes the
							 patient's risk status for life, requiring monitoring not needed before the
							 event
This event is not intended to capture: . procedures
							 where the specimen was properly handled, but the specimen proved to be
							 nondiagnostic. Inability to secure a replacement for a lost specimen can occur
							 with excisional biopsy as well as in organ removal.
1. Patient death or serious injury resulting from
							 failure to follow up or communicatelaborator y, pathology, or radiology test
							 results. Applicable settings: . Hospitals . Outpatient/Office-based Surgery
							 Centers . Ambulatory Practice Settings/ Office-based Practices . Long-term
							 Care/Skilled Nursing Facilities
Includes events where failure to report increased
							 neonatal bilirubin levels result in kernicterus.
Examples of serious injury are a new diagnosis, or an
							 advancing stage of an existing diagnosis (e.g., cancer). Failure to follow up
							 or communicate can be limited to healthcare staff or can involve communication
							 to the patient.
5.ENVIR0NMENTAL EVENTS
EVENT
ADDITIONAL SPECIFICATIONS
IMPLEMENTATION GUIDANCE
A. Patient or staff death or serious injury associated
							 with an electric shock in the course of a patient care process in a
							 healthcaresetting Applicable settings: . Hospitals . Outpatient/Office-based
							 Surgery Centers . Ambulatory Practice Settings/ Office-based Practices .
							 Long-term Care/Skilled Nursing Facilities
Excludes events involving patients during planned
							 treatments such as electric countershock /elective cardioversion.
This event is intended to capture: . patient death or
							 injury associated with unintended electric shock during the course of care or
							 treatment; . staff death or injury associated with unintended electric shock
							 while carrying out duties directly associated with a patient care process,
							 including preparing for care delivery. This event is not intended to capture: .
							 patient death or injury associated with emergency defibrillation in ventricular
							 fibrillation or with electroconvulsive therapies; . injury to staff who are not
							 involved in patient care.
B. Any incident in which systems designated for oxygen
							 or other gas to be delivered to a patient contains no gas, the wrong gas, or is
							 contaminated by toxic substances Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facilities
This event is intended to capture: . events in which
							 the line is attached to a reservoir distant from the patient care unit or in a
							 tank near the patient such as E-cylinders, anesthesia machines.
c. Patient or staff death or serious injury associated
							 with a burn incurred from any source in the course of a patient care process in
							 a healthcaresetting
This event is intended to capture burns that result
							 from: . operating room flash fires, including second degree burn in these
							 cases; . hot water; . sunburn in the patient with decreased ability to sense
							 pain;
Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facilities
. smoking in the patient care environment.
D. Patient death or serious injury associated with the
							 use ofphysical restraints or bed rails while being cared for in a healthcare
							 setting Applicable settings: . Hospitals . Outpatient/Office-based Surgery
							 Centers . Ambulatory Practice Settings/ Office-based Practices . Long-term
							 Care/Skilled Nursing Facilities
The event is intended to capture: . instances where
							 physical restraints are implicated in the death; e.g., lead to
							 strangulation/entrapment, etc.
6.RADI0L0GIC EVENTS
EVENT
ADDITIONAL SPECIFICATION
S
IMPLEMENTATION GUIDANCE
A. Death or serious injury of a patient or staff
							 associated with the introduction of a metallic object into the MRI area
							 Applicable settings: . Hospitals . Outpatient/Office-based Surgery Centers .
							 Ambulatory Practice Settings/ Office-based Practices
Includes events related to material inside the
							 patient's body or projectiles outside the patient's body.
This event is intended to capture injury or death as a
							 result of projectiles including: . retained foreign object . external
							 projectiles . pacemakers
7. POTENTIAL CRIMINAL EVENTS
EVENT
ADDITIONAL SPECIFICATIONS
IMPLEMENTATION GUIDANCE
A. Any instance of care ordered by or provided by
							 someone impersonating a physician, nurse, pharmacist, or other licensed
							 healthcare provider Applicable settings: . Hospitals . Outpatient/Office-based
							 Surgery Centers . Ambulatory Practice Settings/ Office-based Practices .
							 Long-term Care/Skilled Nursing Facilities
This event is intended to capture: . those without
							 licensure to provide the care given; . those with licensure who represent
							 themselves and act beyond the scope of their licensure. It is not intended to
							 capture individuals who are practicing within the scope of their license whom
							 patients or others mistakenly bestow titles beyond that scope when such is not
							 encouraged by the provider.
B. Abduction of a patient/resident of any age
							 Applicable settings: . Hospitals . Outpatient/Office-based Surgery Centers .
							 Ambulatory Practice Settings/ Office-based Practices . Long-term Care/Skilled
							 Nursing Facilities
This event is intended to capture: . removal of a
							 patient/resident, who does not have decision-making capacity, without specific
							 notification and approval by staff even when the person is otherwise authorized
							 to be away from the setting. Examples of individuals who do not have
							 decision-making capacity include: newborns, minors, adults with Alzheimer's.
C. Sexual abuse/assault on a patient or staff member
							 within or on the grounds of a healthcare setting Applicable settings: .
							 Hospitals . Outpatient/Office-based Surgery Centers . Ambulatory Practice
							 Settings/ Office-based Practices . Long-term Care/Skilled Nursing Facilities
Language and definitions may vary based on state
							 statute; however, the principle and intent remain regardless of language
							 required based on jurisdiction.
D. Death or serious injury of a patient or staff
							 member resulting from a physical assault (i.e., battery) that occurs within or
							 on the grounds of a healthcare setting. Applicable settings: . Hospitals .
							 Outpatient/Office-based Surgery Centers . Ambulatory Practice Settings/
							 Office-based Practices . Long-term Care/Skilled Nursing Facilities
Language and definitions may vary based on state
							 statute (e.g., many states have existing statutes that use the terms "first
							 degree assault" or"second degree assault" or "battery").