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

Universal Citation: 10 ME Code Rules ยง 144-114-A
Current through 2024-38, September 18, 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 SPECIFICATIONS 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").

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