hospital patient safety reporting program data dictionary · the data dictionary provides detailed...

The data dictionary provides detailed descriptions of each element in the reporting form. If you have questions or need more information about a particular reporting form question, use the data dictionary to locate specific information about that question. If questions remain after you have consulted the data dictionary, please contact the Commission at 971-266-8079 or [email protected].

How to Use This Document

Each item on the reporting form will appear in its own table including (but not limited to) the following information: question location on the form; question description; responses, where relevant; and a short guide for use, where relevant. The following table defines each row of any given data dictionary table. The tables appear in the same order as on the form. Please use the bookmarks and search features in this document to locate the information you are looking for.

If you need additional assistance or have questions about this document, please contact your patient safety consultant for additional information.

Example of Information Provided in this Data Dictionary

[Question text as it appears in the online form]

Question Location [Indicates on which tab the question can be found in the online form]

Description [Describes the data the question is intended to gather]

Prompt [Provides additional information needed to answer the question as it appears on the online form]

Responses [Lists the possible responses options for multiple choice questions in the order in which they appear on the form]

Go-To Logic [Explains what triggers the appearance of this question, where relevant] [Explains which additional questions will appear based on your answer to this question, where relevant]

Required [Indicates if the question is required; i.e., Yes/No]

Question Type [Indicates the format in which the question appears on the online form (e.g.,. date, text input, dropdown menu, checkbox, etc.)]

Maximum Length [Indicates the maximum length a response can be (i.e., number of characters allowed), if applicable]

Minimum Value [Indicates the lowest value a number field will accept, if applicable]

Maximum Value [indicates the highest value a number field will accept, if applicable]

Guide for Use [Provides instructions for how to answer this question; e.g., additional information to answer the question, when to answer it, inclusions, exclusions, etc.]

HOSPITAL Patient Safety Reporting Program

Data Dictionary

mailto:[email protected]

http://oregonpatientsafety.org/reporting-programs/

http://oregonpatientsafety.org/reporting-programs/

Updated: 12/11/2017 Data Dictionary for Hospitals 2

Content Quick Links How to Use This Document 1

Example of Information Provided in this Data Dictionary 1

Content Quick Links 2

General Information Tab 3

Harm Category Tab 8

Event Tab 14

Contributing Factors Tab 21

Review Tab 26

Summary Tab 29

Additional Questions 31

Anesthesia Event 31

Blood or Blood Product (Including Hemolytic Reactions) Event 33

Contaminated Drugs, Devices or Biologics Event 36

Device or Medical/Surgical Supply (Including Use Error) Event 37

Fall Event 39

Healthcare-Associated Infection (HAI) Event 46

Maternal Event 49

Medication or Other Substance Event 51

Perinatal Event 56

Pressure Ulcer Event 59

Surgical or Other Invasive Procedure Event 64

Unintended Retained Foreign Object Event 66

Appendix I: List of facilities and multi-hospital systems 69

Appendix II: Harm Categories and Algorithm 71

Appendix III: Event Type Descriptions 73

Appendix IV: Anesthesia Event Type Descriptions 78

Appendix V: Healthcare-Associated Infection Event Type Descriptions 79

Appendix VI: Medication or Other Substance Event Type Descriptions 80

Appendix VII: Surgical or Other Invasive Procedure Event Type Descriptions 83

Appendix VIII: Contributing Factor Descriptions 85

Communication 85

Device, equipment, or supply 88

Human or environmental 90

Organizational 91

Policy or procedure 94

Patient management 95

Patient 96


General Information Tab

Event date Question Location General Information Tab Description Date event generating report occurred Prompt n/a Go-To Logic n/a Required Yes Question Type Date

Format mm/dd/yyyy Guide for Use Date the event generating the report occurred, not the date that harm occurred.

Event time Question Location General Information Tab Description Time event generating report occurred Prompt Use military time (hhmm) Go-To Logic n/a Required Yes Question Type Text Input

Format hhmm Maximum Length 5 Minimum Value 0000 Maximum Value 2359 Guide for Use If time is unknown, mark the checkbox “unknown.”

Date discovered Question Location General Information Tab Description Date Quality Management, Risk Management or Patient Safety was notified of the event. Prompt Date quality/risk/patient safety notified of event Go-To Logic n/a Required Yes Question Type Date

Format mm/dd/yyyy Guide for Use The date that the facility/organization (e.g. quality manager, risk manager, patient safety

officer) first became aware of the event. This may or may not be the same date as when the event was first noticed by front-line staff.

Was this event found upon chart review? Question Location General Information Tab Description Event was found in the process of chart review rather than staff incident report Prompt n/a Responses Checked – Yes

Unchecked – No Go-To Logic n/a Required No Question Type Checkboxes Guide for Use A “Yes” response indicates that this event was not discovered in the normal course of clinical

care or an internal incident reporting process, but was instead discovered through a chart review. This includes any form of chart review performed by your organization (e.g. concurrent documentation review, routine audit, peer review, use of the global trigger tool).


Select your multi-hospital system Question Location General Information Tab Description Reporting facility’s hospital system Prompt If your hospital is not part of a multi-hospital system, please choose "non-system." Adventist Health

Asante Health System Capella Healthcare Catholic Health Initiatives Kaiser Permanente Lake Health District Legacy Health PeaceHealth Providence Health & Services Saint Alphonsus Health System Salem Health Samaritan Health Services St. Charles Health System Non-system

Go-To Logic n/a Required Yes Question Type Auto-populated dropdown menu Guide for Use A “multihospital system” is a group of two or more hospitals owned, sponsored, or managed

by a central organization.

Select your facility Question Location General Information Tab Description Determination of which facility is reporting. Prompt n/a Responses Depends on multi-hospital system selected. A full list is available in Appendix I: List of facilities

and multi-hospital systems. Go-To Logic n/a Required Yes Question Type Select Dropdown Guide for Use See Appendix I for List of facilities and multi-hospital systems.

Patient’s gender Question Location General Information Tab Description Patient’s self-identified gender Prompt Please use the patient’s self-identified gender. Responses Female

Male Go-To Logic n/a Required Yes Question Type Select Dropdown Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a

separate form for each patient with their specific demographic data. Other sections of the form may be copied and pasted. If you have questions about this procedure, please contact a patient safety consultant.


Patient’s age Question Location General Information Tab Description Patient’s age at the time of the event being reported. Prompt n/a Go-To Logic n/a Required Yes Question Type Number Maximum Length 3 Minimum Value 0 Maximum Value 128 Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a


Age unit Question Location General Information Tab Description Unit of time in which patient’s age is measured Prompt n/a Responses Years

Months Weeks Days Hours

Default Years Go-To Logic n/a Required Yes Question Type Select Dropdown Guide for Use Select the appropriate unit for the patient’s age. Always choose “years” unless the patient is

less than one year of age. If patient was stillborn, please choose 0 hours. When age is less than 30 minutes, round down to 0 hours. When age is 30 minutes or more, round up to 1 hour.

Note: If you are reporting an event that impacted multiple patients, please complete a separate form for each patient with their specific demographic data. Other sections of the form may be copied and pasted. If you have questions about this procedure, please contact a patient safety consultant.

Patient’s race Question Location General Information Tab Description Patient’s self-identified race. Prompt Check all that apply. Responses American Indian or Alaskan Native

Asian Black or African American Native Hawaiian or Pacific Islander White Other Unknown

Go-To Logic n/a Required Yes


Question Type Checkboxes Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a


Patient’s ethnicity Question Location General Information Tab Description Patient’s self-identified ethnicity. Prompt Check one. Responses Hispanic

Not Hispanic Unknown

Go-To Logic n/a Required Yes Question Type Radio Buttons Guide for Use Note: If you are reporting an event that impacted multiple patients, please complete a


Contact name Question Location General Information Tab Description Name of participant facility’s Patient Safety Reporting Program contact person Prompt Who should we contact for clarification or feedback? Go-To Logic n/a Required Yes Question Type Text Input Maximum Length 128 Guide for Use No further information provided.

Contact email address Question Location General Information Tab Description Participant facility’s Patient Safety Reporting Program contact person’s email address Prompt n/a Go-To Logic n/a Required No Question Type Text Input

Format: must be a valid email address Maximum Length 100 Guide for Use No further information provided.

Contact phone Question Location General Information Tab Description Participant facility’s Patient Safety Reporting Program contact person’s phone number Prompt n/a Go-To Logic n/a Required Yes Question Type Text Input

Format: (xxx) xxx-xxxx Maximum Length 15


Guide for Use No further information provided.

Contact extension Question Location General Information Tab Description Participant facility’s Patient Safety Reporting Program contact person’s phone extension Prompt n/a Go-To Logic n/a Required No Question Type Text Input Maximum Length 10 Guide for Use No further information provided.


Harm Category Tab

Did an actual adverse event occur? Question Location Harm Category Tab Description Determination of whether or not an adverse event occurred. Prompt Adverse event: an event resulting in unintended harm or creating the potential for harm that

is related to any aspect of a patient’s care (by an act of commission or omission) rather than to the underlying disease or condition of the patient. Adverse events may or may not be preventable.)

Responses Yes No

Go-To Logic If “yes,” opens the question “Did the event reach the patient?” If “no,” assigns harm category A (circumstances that have the capacity to cause harm) and section is complete.

Required Yes Question Type Radio buttons Guide for Use See Appendix II for Harm Categories and Algorithm.

Did the event reach the patient? Question Location Harm Category Tab Description Determination of whether or not the event reached the patient. Prompt An error of omission does reach the patient. Responses Yes

No Go-To Logic Only appears if the question “Did an actual adverse event occur” was answered “yes.”

If “yes,” opens the question “Did the event contribute to or result in patient death?” If “no,” assigns harm category B (event occurred that did not reach the patient) and opens the question “What prevented the event from reaching the patient?”

Required If this question appears on your form, it is required. Question Type Radio buttons Guide for Use See Appendix II for Harm Categories and Algorithm.

Did the event contribute to or result in patient death? Question Location Harm Category Tab Description Determination of whether or not the event resulted in or contributed to the patient’s death. Prompt n/a Responses Yes

No Go-To Logic Only appears if the question “Did the event reach the patient?” is answered “yes.”

If “yes,” assigns harm category I (event may have contributed or resulted in patient’s death) and section is complete. If “no,” opens the question “Was the patient harmed?”



Was the patient harmed? Question Location Harm Category Tab Description Determination of whether or not the patient was harmed. Prompt Harm: any physical injury or damage to the health of a person requiring additional medical

care, including both temporary and permanent injury. Responses Yes

No Go-To Logic Only appears the question “Did the event contribute to or result in patient death?” is

answered “no.” If “yes,” opens the question “Was an intervention necessary to sustain life required?” If “no,” opens the question “Was an intervention to preclude harm/extra monitoring required?”


Was an intervention to preclude harm/extra monitoring required? Question Location Harm Category Tab Description Determination of whether or not extra monitoring or an intervention to preclude harm was

required. Prompt Monitoring: to observe or record physiological or psychological signs. Responses Yes

No Go-To Logic Only appears if the question “Was the patient harmed?” is answered “no.”

If “yes,” assigns harm category D (event reached patient and required monitoring to confirm that it resulted in no harm and/or required intervention to preclude harm) and opens the question “Which intervention to preclude harm was required?” If “no,” assigns harm category C (event reached patient but did not cause patient harm) and section is complete.


Was an intervention necessary to sustain life required? Question Location Harm Category Tab Description Determination of whether or not an intervention necessary to sustain life was required. Prompt Intervention necessary to sustain life: includes cardiovascular and/or respiratory support

(e.g., CPR, defibrillation, intubation, etc.). Responses Yes

No Go-To Logic Only appears if the question “Was the patient harmed?” is answered “yes.”

If “yes,” opens the question “Was the harm permanent?” If “no,” opens the question “Was the harm temporary?”



Was the harm permanent? Question Location Harm Category Tab Description Determination of whether or not patient harm was permanent. Prompt Permanent harm: harm lasting more than 6 months or where the end harm is not known. Responses Yes

No Go-To Logic Only appears if the question “Was an intervention necessary to sustain life required?” is

answered “yes.” If “yes,” assigns harm category G (event may have contributed to or resulted in permanent patient harm) and opens the question “What was the extent of harm to the patient?” If “no,” assigns harm category H (event required intervention necessary to sustain life) and opens the question “What was the extent of harm to the patient?”

Required If this question appears on your form, it is required. Question Type Radio buttons Guide for Use See Appendix II for Harm Categories and Algorithm. Pressure ulcers Stage III and above are always

permanent harm.

Was the harm temporary? Question Location Harm Category Tab Description Determination of whether or not patient harm was temporary. Prompt n/a Responses Yes

No Go-To Logic Only appears if the question “Was an intervention necessary to sustain life required?” is

answered “no.” If “yes,” opens the question “Did the event require any of the following significant interventions?” If “no,” assigns harm category G (event may have contributed to or resulted in permanent patient harm) and opens the question “What was the extent of harm to the patient?”

Required If this question appears on your form, it is required. Question Type Radio buttons Guide for Use Pressure ulcers Stage III and above are always permanent harm.

Did the event require any of the following significant interventions? Question Location Harm Category Tab Description Determination of the intervention(s) performed as a result of the adverse event. Prompt Check all that apply. A “significant intervention” is an intervention intended to relieve

symptoms that have the potential to be life-threatening if not addressed. Responses Initial or prolonged hospitalization

Move to a higher level of care Surgical/procedural intervention Respiratory or cardiovascular support (e.g., ventilation, tracheotomy) Unplanned blood transfusion Medication therapy (including administration of rescue drug or antidote) Other significant intervention (please describe) No significant intervention

Go-To Logic Only appears if the question “Was the harm temporary?” is answered “yes.” If “No significant intervention” is selected, no other response can also be selected, the form assigns harm category E (event may have contributed to or resulted in temporary harm but did not require significant intervention) and opens the question “What was the extent of harm to the patient?”


If any response(s) other than “No significant intervention” is selected, assigns harm category F (event may have contributed to or resulted in temporary harm and required a significant intervention) and opens the question “What was the extent of harm to the patient?” If “other significant intervention,” a text box for description will also open.

Required If this question appears on your form, it is required. Question Type Checkboxes Guide for Use A “significant intervention” is an intervention intended to address a condition or relieves

symptoms resulting from a condition that has the potential to cause additional serious physical injury or to be life-threatening if not addressed. Initial or prolonged hospitalization INCLUDES:

• Moving from a hospital to a nursing facility, if that is not the patient’s point of origin. Move to a higher level of care INCLUDES:

• Within the facility

• Transfer to another facility

• Hospital admission from outpatient

• A return to hospice, comfort care or palliative care, or to a nursing home, if that is the person’s usual residence, does not count as a move to a higher level of care.

Medication therapy INCLUDES:

• Administration of a rescue drug or antidote (e.g. narcan, epinephrine) Surgical intervention INCLUDES:

• I&D (incision and drainage)

• Evacuation of a post-surgical hematoma

• ORIF (hip surgery) post-fall Unplanned blood transfusion EXCLUDES:

• Transfusion as an expected part of surgical care Respiratory and cardiovascular support (e.g., ventilation, tracheotomy) INCLUDES:

• Respiratory and/or cardiovascular support that was required as a direct result of the adverse event.

EXCLUDES:

• Respiratory and/or cardiovascular support that was a part of patient care prior to the adverse event.

Other significant intervention INCLUDES:

• Calling a rapid response team (RRT)

The Harm Category for this event is: Question Location Harm Category Tab Description Harm category assigned by answering questions adapted from the NCC-MERP Harm Category

Algorithm. Prompt n/a – harm category automatically assigned by reporting system Responses Category A

Circumstances that have the capacity to cause an adverse event

Category B

An event occurred that did not reach the patient (an “error of omission” does reach the

patient)


Category C

An event occurred that reached the patient but did not cause patient harm

Category D

An event occurred that reached the patient and required monitoring to confirm that it resulted

in no harm to the patient and/or required intervention to preclude harm

Category E

An event occurred that may have contributed to or resulted in temporary harm to the patient

but did not require significant intervention

Category F

An event occurred that may have contributed to or resulted in temporary harm to the patient

and required a significant intervention

Category G

An event occurred that may have contributed to or resulted in permanent patient harm

Category H

An event occurred that required intervention necessary to sustain life

Category I

An event occurred that may have contributed to or resulted in patient’s death Go-To Logic n/a – harm category automatically assigned by reporting system Required n/a – harm category automatically assigned by reporting system Question Type n/a – harm category automatically assigned by reporting system Guide for Use If you chose more than one event type, please select the highest applicable level of harm. See

Appendix II for Harm Categories and Algorithm.

What was the extent of harm to the patient? Question Location Harm Category Tab Description The extent of harm to the patient after discovery of the incident and any attempts to

minimize adverse consequences. Prompt Check one. Which best describes the extent to which the patient’s functional ability is

expected to be impaired, based on your present assessment of the patient’s future condition attributable to the event, taking the likely effects of treatment into account?

Responses Severe harm: bodily injury (including pain or disfigurement) that interferes significantly with functional ability or quality of life

Moderate harm: bodily injury adversely affecting functional ability or quality of life, but not at the level of severe harm

Mild harm: minimal symptoms or loss of function, or injury limited to additional treatment, monitoring, and/or increased length of stay

Go-To Logic Only appears if harm category is E, F, G or H. Required No Question Type Radio buttons Guide for Use Your selection among these categories should be based on your present assessment of the

patient's future condition attributable to the incident, taking the likely effects of treatment into account. If you cannot decide between two categories that you believe both apply, select the one that is higher on the list.


What prevented the event from reaching the patient? Question Location Harm Category Tab Description Determination of what process prevented the near miss from reaching the patient. Prompt n/a Responses Fail-safe/safeguard worked effectively

Action by a practitioner or staff who made the error prevented the event form reaching the patient

Action by a practitioner or staff member (other than person making the error) prevented the event from reaching the patient

Action by the patient or patient’s family member prevented the event from reaching the patient

Unknown Other (please describe)

Go-To Logic Only appears if harm category is B. If “other,” a text box for description will also open.

Required No Question Type Select Dropdown Guide for Use The answer selections are intended to be mutually exclusive. However, if it appears to you

that “Fail-safe/safeguard worked effectively” and one of the other selections both apply, select “Fail-safe/safeguard worked effectively.”

Which intervention to preclude harm was required? Question Location Harm Category Tab Description Specification of intervention(s) performed as a result of the adverse event to preclude harm. Prompt Check all that apply. Increased length of stay

Monitoring, including observation, physiological examination, laboratory testing, phlebotomy, and/or imaging studies

Medication therapy (excluding administration of rescue drug or antidote) Other intervention (please describe)

Go-To Logic Only appears if harm category is D. If “other intervention,” a text box for description will also open.

Required If this question appears on your form, it is required. Question Type Checkboxes Guide for Use Increased length of stay

INCLUDES:

• Additional time in the facility for monitoring or observation EXCLUDES:

• Initial hospitalization from outpatient. If an initial hospitalization was required, the patient suffered harm.

• Prolonged stay in the facility for additional surgery or other invasive procedure. If an additional surgery or other invasive procedure is required, the patient suffered harm.

Monitoring INCLUDES:

• Observation

• Physiological examination

• Laboratory testing

• Phlebotomy

• Imaging studies

Medication therapy


INCLUDES:

• Change in pre-incident dose or route EXCLUDES:

• Administration of a rescue drug or antidote. If a rescue drug or antidote was required, the patient suffered harm.

Other intervention INCLUDES:

• Non-surgical intervention for a fracture

Event Tab

Event Type Question Location Event Tab Description Determination of the event type that is being reported. Prompt Check only one. If the event consists of multiple event types, select only the precipitating

event that best describes the situation. In rare cases, reports may involve two distinct adverse events in which case multiple adverse events may be selected.

Responses Air embolism Anesthesia* Aspiration Blood or blood product (including hemolytic reactions)* Burn (unrelated to the use or misuse of a device or medical/surgical supply) Care delay (including delay in treatment, diagnosis) Contaminated drugs, devices or biologics* Contaminated, wrong or no gas given to a patient Device or medical/surgical supply (including use error)* Discharge or release of a patient of any age, who is unable to make decisions, to an

unauthorized person Electric shock Elopement Failure to follow up or communicate laboratory, pathology, or radiology test results Fall* Healthcare-associated infection (HAI)* Irretrievable loss of irreplaceable biological specimen Maternal* Medication or other substance* Perinatal* Pressure ulcer* Radiologic Restraint or bedrail related Suicide or attempted suicide Surgical or other invasive procedure (including incorrect site, incorrect patient and incorrect

procedure)* Unintended retained foreign object* Other event (please describe)

Go-To Logic If “other,” a text box for description will also open. If any of the following event types are selected, additional event specific questions will populate after “Additional Event Information” as indicated below:

Anesthesia “Anesthesia event type,” “Was a briefing conducted prior to the induction of anesthesia?,” “Patient’s ASA class,” and “Was care provided under emergency circumstances?”


Blood or blood product (including hemolytic reactions) “Which best describes the event?” and “Type of blood product involved.”

Contaminated drugs, devices or biologics “Was the event reported to MedWatch?”

Device or medical/surgical supply (including use error) “Which best describes the event?”, “Type of device or supply involved”, “Specific device”, and “Was the event reported to MedWatch?”

Fall “Was a fall risk assessment documented?”, “Was the patient assessed to be at any level of risk for a fall?”, “Date of most recent falls assessment,” “Was the patient on medication known to increase fall risk at the time of the fall?”, “Was the medication considered to have contributed to the fall?”, “Were any of the following risk factors present at the time of the fall?”, “Were any of the following risk factors considered to have CONTRIBUTED to the fall?”, “Which of the following were in the patient’s care plan to prevent falls?”, “Which of the following were in place and being used to prevent falls for this patient?”, “Prior to the fall, what was the patient doing or trying to do?”, “What was the patient’s goal? Why did s/he get up or try to get up?”, “Was the fall observed?”, “Was the fall assisted or unassisted?”, “Did any physical device contribute to the fall?”, “What was the physical or environmental cause of the fall?”, “Did the patient sustain a physical injury as a result of the fall?”, and “What type of injury was sustained?”

Healthcare-associated infection (HAI) “Type of healthcare-associated infection (HAI)”, “Was the infection determined to be present or incubating on admission?” and “Type of pathogen.”

Maternal “Gestational age”, “Was labor induced or augmented?”, “What was the final mode of delivery?”, “Did the delivery involve the following?”, and “Which adverse outcome(s) did the mother sustain?”

Medication or other substance “Type of medication or other substance event”, “What type of medication/substance was involved?”, “Generic name or investigational drug name(s)”, “Was this medication/substance prescribed for this patient?”, “Was this medication/substance given to this patient?”, “At what stage in the process did the event originate, regardless of the stage at which it was discovered?” and “Were any of the following involved?”

Perinatal “Gestational age”, “Was labor induced or augmented?”, “What was the final mode of delivery?”, “Did the delivery involve the following?”, and “Did the event affect a fetus or a neonate?”

Pressure ulcer “Most advanced stage of pressure ulcer being reported”, “What was the stage on admission of the pressure ulcer?”, “Pressure ulcer location on the body”, “On admission to the facility, was a skin inspection documented?”, “When was the first pressure ulcer risk assessment documented?”, “Was any preventive intervention implemented?”, and “Was the use of a device or appliance involved in the development or advancement of the pressure ulcer?”

Surgical or other invasive procedure “Type of surgical or other invasive procedure event”, “Number of staff changes (after timeout)”, “Was a safe surgery/procedure checklist used?”, “Patient’s ASA class,” and “Was care provided under emergency circumstances?”


Unintended retained foreign object “Number of staff changes (after timeout)”, “Was a safe surgery/procedure checklist used?”, “Type of retained object”, “Were counts performed for the type of object that was retained?”, “Was the retained object identifiable by any of the following?”, “Did the surgeon perform a cavity sweep?”, “Patient’s ASA class,” and “Was care provided under emergency circumstances?”

Required Yes Question Type Checkboxes Guide for Use See Appendix III: Event Type Definitions for further guidance. You may also want to refer to

the PSRP Corner article on this topic (https://oregonpatientsafety.org/blog/blog/which-event-type-should-i-select/681/). Please note: “Hyperbilirubinemia” should be submitted as a “Failure to follow up or communicate laboratory, pathology, or radiology test results” event. “Hypoglycemia” should be submitted as a “Medication or other substance” event. “Intraoperative or immediately postoperative/postprocedure death in an ASA Class 1 patient” should be submitted as a “Surgical or other invasive procedure” event. “Spinal manipulative therapy should be submitted as a “Surgical or other invasive procedure” event.

Event location Question Location Event Tab Description Determination of where the event occurred or where the unsafe condition existed. Prompt Select the location where the event occurred, or originated, regardless of the location in

which it was discovered Responses Bathroom (toileting, bathing, tub/shower room)

Behavioral health Critical care (adult) Critical care (pediatric, NICU) Day/ambulatory surgery Diagnostic/procedure area Emergency department Inpatient (adult) Inpatient (pediatric, nursery) Laboratory (including pathology department and blood bank) Labor and delivery Mother/baby Pharmacy Preop area Operating/procedure room Post anesthesia care unit Radiology/imaging Rehab/therapy room Swing bed Other (please describe)

Go-To Logic If “other,” a text box for description will also open. Required Yes Question Type Select Dropdown Guide for Use Select the answer that best describes the location of the event as specifically as possible. For

locations that fall under two categories (such as a bathroom in an inpatient department), choose the more specific location (in the case of the example, the bathroom). Mother/baby is also Postpartum. “Cath lab” or similar should be considered “Operating/procedure room.” You may also want to refer to the PSRP Corner article on this topic (https://oregonpatientsafety.org/blog/blog/how-do-i-choose-the-correct-event-

https://oregonpatientsafety.org/blog/blog/which-event-type-should-i-select/681/

https://oregonpatientsafety.org/blog/blog/which-event-type-should-i-select/681/

https://oregonpatientsafety.org/blog/blog/how-do-i-choose-the-correct-event-location/627/


location/627/).

Relevant surgeries or procedures Question Location Event Tab Description Brief description of patient surgeries or procedures related to the event. Prompt Please list surgeries or procedures connected or related to the reported event (e.g., knee

surgery, central line insertion). Go-To Logic n/a Required Yes, if the event type is Anesthesia, Unintended retained foreign object, or Surgical or other

invasive procedure. Otherwise it is not required.

Question Type Text Input Guide for Use List procedures connected or related to the reported event (i.e., those contributing to the

event and those performed as a result of, or to prevent an event from occurring).

Admitting diagnosis Question Location Event Tab Description Brief description of patient admitting primary diagnosis. Prompt Only indicate primary diagnosis. ICD-9 not required. Go-To Logic n/a Required No Question Type Text Input Guide for Use No further information provided.

Relevant comorbidities Question Location Event Tab Description Brief description of patient comorbidities related to the event. Prompt Please list co-morbidities related to the reported event. Go-To Logic n/a Required No Question Type Text Input Guide for Use An existing medical condition or disease process that played a role in the adverse event.

How preventable was the incident? Question Location Event Tab Description Determination of how preventable the specific incident being reported was. Prompt n/a Responses Almost certainly could have been prevented

Likely could have been prevented Likely could not have been prevented Almost certainly could not have been prevented Unknown

Go-To Logic This question only appears if the Harm Category is C, D, E, F, G, H or I. Required No Question Type Dropdown select Guide for Use No further information provided.

What was the patient’s documented ASA Class? Question Location Event Tab Description Determination of the patient's documented American Society of Anesthesiologists (ASA)

Physical Classification System class.

https://oregonpatientsafety.org/blog/blog/how-do-i-choose-the-correct-event-location/627/


Prompt Only events involving an invasive procedure for which ASA Class was not determined should mark “n/a.”

Responses Class 1 Class 2 Class 3 Class 4 Class 5 Unknown n/a

Go-To Logic This question only appears if the event type is Anesthesia, Unintended retained foreign object, or Surgical or other invasive procedure.

Required Yes, if the event type is Anesthesia, Unintended retained foreign object, or Surgical or other invasive procedure. Otherwise it is not required.

Question Type Select Dropdown Guide for Use Enter the American Society of Anesthesiologists (ASA) Physical Classification System class

assignment as documented in the medical record prior to the procedure. The class assignment is frequently found in a designated space on the anesthesia record. If no class was assigned, select choice “Unknown.” Do not attempt to apply the ASA's class descriptions retrospectively. Only events involving an invasive procedure for which ASA Class was not determined should mark “n/a.”

Was care provided under emergency circumstances? Question Location Event Tab Description Determination if the surgery or other invasive procedure was performed as an emergency. Prompt n/a Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Anesthesia, Unintended retained foreign object, or Surgical or other invasive procedure.

Required No Question Type Radio Buttons Guide for Use This excludes emergency care provided in response to the adverse event, unless that care

resulted in an additional adverse event.

Was the event associated with HIT (Health Information Technology)? Question Location Event Tab – Additional Questions Section Description Determination of whether or not HIT was involved in the event. Prompt n/a Responses Yes

No Go-To Logic If “yes,” opens the questions “Type of HIT device involved” and “Which of the following

describes the circumstances involving the HIT in the event?” Required No Question Type Radio buttons Guide for Use No further information provided.

Type of HIT device involved Question Location Event Tab – Additional Questions Section Description Documentation of the type of HIT device involved. An HIT device includes hardware or


software that is used to electronically create, maintain, analyze, store, or receive information to aid in the diagnosis, cure, mitigation, treatment, or prevention of disease and that is not an integral part of (1) an implantable device or (2) an item of medical equipment.

Prompt n/a Responses Automated dispensing system (e.g., pyxis)

EHR or component of EHR Human interface device (e.g., keyboard, monitor/display, speech recognition system) Laboratory information system, including microbiology and pathology systems Radiology/diagnostic imaging system (including PACS) Other (please describe)

Go-To Logic Only appears if the question “Was the event associated with HIT?” is answered “yes.” If “EHR or component of EHR,” opens the question “Type of EHR involved.” If “other,” a text box for description will also open.

Required No Question Type Select Dropdown Guide for Use No further information provided

Type of EHR involved Question Location Event Tab – Additional Questions Section Description Determination of what type of EHR or EHR component is involved in the event being

reported. Prompt n/a Responses Computerized provider order entry (CPOE) system

Pharmacy system Clinical documentation system (e.g., progress notes) Clinical decision support (CDS) system Electronic medication administration record (eMAR) Other (please describe)

Go-To Logic Only appears if “Type of HIT device involved” is “EHR or component of EHR.” If “other,” a text box for description will also open.

Required No Question Type Select Dropdown Guide for Use No further information provided.

Which of the following describes the circumstances involving the HIT in the event? Question Location Event Tab – Additional Questions Section Description Determination of the circumstances involved in the event or unsafe condition. Prompt Check all that apply. Responses Incompatibility between devices

HIT function HIT maintenance Hardware failure or problem Network failure or problem Human/device interface or other ergonomics issue Security, virus, or other malware issue Unexpected software design issue Unknown Other (please describe)

Go-To Logic Only appears if the question “Was the event associated with HIT?” is answered “yes.” If “HIT function,” opens the question “Which problem(s) resulted from the HIT function problem?” If “Human/device interface or other ergonomics issue,” opens the question “Which


human/device interface or ergonomics issue(s) were involved?” If “other,” a text box for description will also open.

Required No Question Type Checkboxes Guide for Use No further information provided.

Which problem(s) resulted from the HIT function problem? Question Location Event Tab – Additional Questions Section Description Determination of the problem(s) resulting from the HIT function problem. Prompt Check all that apply. Responses Loss or delay of data

System returns or stores data that does not match patient Image measurement/corruption issue Image orientation incorrect Incorrect test results Incorrect software programming calculation Incorrect or inappropriate alert Other (please describe)

Go-To Logic Only appears if “Which of the following describes the circumstances involving the HIT in the event?” was answered “HIT function.” If “other,” a text box for description will also open.


Which human/device interface or ergonomics issue(s) were involved? Question Location Event Tab – Additional Questions Section Description Determination of the problem resulting from the human/device interface or ergonomics

issue. Prompt Check all that apply. Responses Hardware location (e.g., awkward placement for use)

Data entry or selection (e.g., entry or selection of incorrect patient, incorrect provider, incorrect drug, incorrect dose) Alert fatigue/alarm fatigue Information display or interpretation (e.g., font size, color of font, location of information in display screen) Other (please describe)

Go-To Logic Only appears if “Which of the following describes the circumstances involving the HIT in the event?” was answered “Human/device interface or other ergonomics issue.” If “other,” a text box for description will also open.


For event-specific additional questions, see “Additional Questions” section of data dictionary, following “Summary Tab” section.


Contributing Factors Tab

Communication Question Location Contributing factors tab Description Determination if any contributing factor(s) related to communication are known. Prompt Were communication factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Communication factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Communication factors Question Location Contributing factors Description Determination of which contributing factor(s) related to communication are known. Prompt Check all that apply. Responses Among healthcare team members

Across units Among interdisciplinary teams Between providers and staff Between supervisor and staff Handoffs, handovers or shift reports Hard to read fax or handwriting Within units With other organizations or outside providers Other (please describe) With patients/families Culture Language Miscommunication Patient did not use call light Patient unable to communicate Understanding of discharge instructions or plan Other (please describe)

Go-To Logic This question only appears if “Communication” was answered “yes.” If “other,” a text box for description will also open.

Required If “Communication” is answered “yes,” then one of these options must be selected. Otherwise it is not required.

Question Type Checkboxes Guide for Use See Appendix VIII: Contributing Factor Descriptions for further guidance.

Device, equipment, or supply Question Location Contributing factors Description Determination if any contributing factor(s) related to devices, equipment, or supplies are

known. Prompt Were device, equipment, or supply factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Device, equipment, or supply factors.” Required Yes


Question Type Radio Buttons Guide for Use No further information provided.

Device, equipment, or supply factors Question Location Contributing factors Description Determination of which contributing factor(s) related to devices, equipment, or supplies are

known. Prompt Check all that apply. Responses Availability

Design Function (e.g., defective, non-working) Maintenance Shortage Use or selection by healthcare provider or staff Use by patient Other (please describe)

Go-To Logic This question only appears if “Device, equipment, or supply” was answered “yes.” If “other,” a text box for description will also open.

Required If “Device, equipment, or supply” is answered “yes,” then one of these options must be selected. Otherwise it is not required.


Human and environmental Question Location Contributing factors Description Determination if any contributing factor(s) related to human or environmental factors are

known. Prompt Were human or environmental factors involved in this event? Human factors refer to

healthcare professionals and staff only. For patient factors, use the Patient Factors category below.

Responses Yes No

Go-To Logic If “yes,” opens the question “Human and environmental factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Human and environmental factors Question Location Contributing factors Description Determination of which contributing factor(s) related to human or environmental factors are

known. Prompt Check all that apply. Responses Alarm fatigue

Clutter Interruptions or distractions Lighting Noise Provider or staff fatigue Provider or staff health issues Provider or staff stress Work area design and specifications


Other (please describe) Go-To Logic This question only appears if “Human and environmental” was answered “yes.”

If “other,” a text box for description will also open. Required If “Human and environmental” is answered “yes,” then one of these options must be

selected. Otherwise it is not required.

Question Type Checkboxes Guide for Use See Appendix VIII: Contributing Factor Descriptions for further guidance. Includes both

individual and environmental factors, which influence behavior at work in a way that can affect health and safety. You may also want to refer to the PSRP Corner article on this topic

(https://oregonpatientsafety.org/blog/blog/why-isnt-the-patient-included-in-human-factors/634/).

Organizational Question Location Contributing factors Description Determination if any contributing factor(s) related to the organization are known. Prompt Were organizational factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Organizational factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Organizational factors Question Location Contributing factors Indicate which organizational factor(s). Description Determination of which contributing factor(s) related to the organization are known. Prompt Check all that apply. Responses Adequacy of budget

Assignment or work allocation Clinical supervision Culture of safety Internal reporting Job orientation or training Managerial supervision Management or leadership skills Staff competencies Staffing levels Systems to identify risk Temporary staffing Other (please describe)

Go-To Logic This question only appears if “Organizational” was answered “yes.” If “other,” a text box for description will also open.

Required If “Organizational” is answered “yes,” then one of these options must be selected. Otherwise it is not required.


Policy or procedure Question Location Contributing factors Description Determination if any contributing factor(s) related to policies or procedures are known. Prompt Were policy or procedure factors involved in this event?

https://oregonpatientsafety.org/blog/blog/why-isnt-the-patient-included-in-human-factors/634/

https://oregonpatientsafety.org/blog/blog/why-isnt-the-patient-included-in-human-factors/634/


Responses Yes No

Go-To Logic If “yes,” opens the question “Policy or procedure factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Policy or procedure factors Question Location Contributing factors Description Determination of which contributing factor(s) related to policies or procedures are known. Prompt Check all that apply. Responses Clarity of policy or procedure

Policy or procedure absent Provider or staff unfamiliar with policy or procedure Policy or procedure too cumbersome Work-around more efficient Other (please describe)

Go-To Logic This question only appears if “Policy or procedure” was answered “yes.” If “other,” a text box for description will also open.

Required If “Policy or procedure” is answered “yes,” then one of these options must be selected. Otherwise it is not required.

Question Type Checkboxes Guide for Use No further information provided.

Patient management Question Location Contributing factors Description Determination if any contributing factor(s) related to patient management are known. Prompt Were patient management factors involved in this event? Responses Yes

No Go-To Logic If “yes,” opens the question “Patient management factors.” Required Yes Question Type Radio Buttons Guide for Use See Appendix VIII: Contributing Factor Descriptions for further guidance.

Patient management factors Question Location Contributing factors Indicate which patient management factor(s). Description Determination of which contributing factor(s) related to patient management are known. Prompt Check all that apply. Responses Follow-up care

Initial diagnosis Response to changing condition or delay in care Risk assessment Treatment or care plan Other (please describe)

Go-To Logic This question only appears if “Patient management” was answered “yes.” If “other,” a text box for description will also open.

Required If “Patient management” is answered “yes,” then one of these options must be selected. Otherwise it is not required.



Patient Question Location Contributing factors Description Determination if any contributing factor(s) related to patients are known. Prompt Were patient factors involved in this event? (e.g., behavioral or mental status, family

dynamics, fragile health status, etc.). Responses Yes

No Go-To Logic If “yes,” opens the question “Patient factors.” Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Patient factors Question Location Contributing factors Description Determination of which contributing factor(s) related to patients are known. Prompt Check all that apply. Responses Behavioral status

Family dynamics or relationships Fragile health status Mental status Physical limitations Sensory impairment (vision, hearing, balance, etc.) Other (please describe)

Go-To Logic This question only appears if “Patient” was answered “yes.” If “other,” a text box for description will also open.

Required If “Patient” is answered “yes,” then one of these options must be selected. Otherwise it is not required.

Question Type Checkboxes Guide for Use See Appendix VIII: Contributing Factor Descriptions for further guidance. If the patient was

non-compliant, please consider WHY the patient may not have complied.


Review Tab

Date review and analysis completed Question Location Review tab Description Date the investigation team completed its review and analysis of the event. Prompt n/a Go-To Logic n/a Required Yes Question Type Date

Format: mm/dd/yyyy Guide for Use No further information provided.

Members of the review and analysis team Question Location Review tab Description Determination of the job roles of the members of the review and analysis team. Prompt Check all that apply. Responses Anesthesia provider

Engineering/biomed/materials management Family/patient/patient representative Health information technology/information services Infection control Nursing management Nursing staff Patient safety Pharmacist(s) Physician(s) Quality management Rehabilitation staff Respiratory therapy Risk management Senior management/administrator Other (please describe)

Go-To Logic If “other,” a text box for description will also open. Required Yes Question Type Checkboxes Guide for Use No further information provided.

Person hours spent in review Question Location Review tab Description Number of person hours spent in the review and analysis process. Prompt Please approximate the combined total number of hours that all individuals involved

contributed to the review and analysis of this event. Go-To Logic n/a Required Yes Question Type Number Guide for Use See the PSRP Corner article on this topic (https://oregonpatientsafety.org/blog/psrp-

corner/psrp-corner-how-do-i-calculate-person-hours-in-review-in-my-report/559).

https://oregonpatientsafety.org/blog/psrp-corner/psrp-corner-how-do-i-calculate-person-hours-in-review-in-my-report/559

https://oregonpatientsafety.org/blog/psrp-corner/psrp-corner-how-do-i-calculate-person-hours-in-review-in-my-report/559


Who was notified of this event? Question Location Review tab Description Determination of which facility or organization executives were notified of the event. Prompt Check all that apply. Responses Senior management

Board of directors Neither of these were notified

Go-To Logic n/a Required Yes Question Type Checkboxes Guide for Use No further information provided.

Did the review and analysis team have a post-analysis briefing with senior management? Question Location Review tab Description Determination of whether or not the review and analysis team briefed senior management

after completing their review and analysis. Prompt Either in person (with the whole team or a single representative) or through a senior leader

review of the analysis findings and outcomes. Responses Yes

No Go-To Logic n/a Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Who was given written notification? Question Location Review tab Description Determination of who was given written notification of the event. Prompt Check all that apply. Responses Patient

Patient representative None given

Go-To Logic If “none given,” opens the question “Please specify why no written notification was given.” Required Yes Question Type Checkboxes Guide for Use No further information provided.

Please specify why no written notification was given Question Location Review tab Description Determination of why no one was given written notification of the event. Prompt Check all that apply Responses Written notification pending

No organizational policy Not required by organizational policy Not required by Commission definitions Oral disclosure Unable (please describe) Other (please describe)

Go-To Logic This question only appears If “Who was given written notification?” is answered “none given.”


If “other” or “unable,” a text box for description will also open. Required No Question Type Checkboxes Guide for Use No further information provided.


Summary Tab Instructions: The Commission evaluates reports to support healthcare organizations in conducting in-depth investigations focused on preventing future adverse events. Acceptable quality is determined using four criteria: completeness, thoroughness, credibility, and effective action plans (see the Quality Criteria document in the Tools and Resources menu above).

Please do not use patient, provider, or facility names to describe the adverse event. If you want to refer to a specific healthcare provider, please use general terms (for example, use a generic description, such as doctor or nurse 1).

Complete account Question Location Summary Tab Description Complete, narrative account of event. Prompt Briefly summarize the circumstances leading up to the event. The summary should describe

the role contributing factors played and the system practices and processes involved, and may briefly describe relevant patient clinical progress. Include enough information so that someone unfamiliar with the event could easily understand how the event happened.

Go-To Logic n/a Required Yes Question Type Text area (memo field) Guide for Use You may also want to refer to the PSRP Corner article on this topic

(https://oregonpatientsafety.org/blog/blog/what-information-should-i-include-in-the-complete-account/641/).

Causes and Action Plans Instructions: For the following questions, identify up to five causes and associated action plans that your organization will take to prevent occurrence of similar events. Include at least one root cause and one system-level action plan. Show a clear link between the cause and the action plan. A root cause identifies underlying processes and gaps in practice related to the event. A system-level action plan focuses on processes, practices, and procedures, rather than individuals, and has the greatest likelihood of preventing future occurrences. (Note: you do not need to describe your implementation plan.)

Cause Question Location Summary Tab Description Cause or finding from event review and analysis. Prompt n/a Go-To Logic n/a Required Yes Question Type Text area (memo field) Guide for Use No further information provided.

Is this a root cause? Question Location Summary Tab Description Determination of whether or not cause or finding was a root cause. Prompt n/a Responses Yes

No Go-To Logic n/a Required Yes Question Type Radio Buttons Guide for Use A “root cause” is a condition or circumstance that prompted an action that led to the event or

https://oregonpatientsafety.org/blog/blog/what-information-should-i-include-in-the-complete-account/641/

https://oregonpatientsafety.org/blog/blog/what-information-should-i-include-in-the-complete-account/641/


near miss occurrence or harm. The most basic cause(s) are often several steps removed from the action (or inaction) that precipitated the event or near miss. Correction of a root cause within the system can prevent (or significantly reduce the likelihood of) the recurrence of the event or near miss.

Action Plan Question Location Summary Tab Description The action plan that addresses the cause or finding and is designed to prevent occurrence of

similar events. Prompt n/a Go-To Logic n/a Required Yes Question Type Text area (memo field) Guide for Use No further information provided.


Additional Questions

Anesthesia Event

Anesthesia event type Question Location Event Tab – Additional Questions Section Description Determination of which best describes this anesthesia event: awareness, malignant

hyperthermia, over-sedation, or incorrect site anesthesia. Prompt Check all that apply. If the anesthesia event involved a device, please also submit as a “device

or medical/surgical supply” event. If the anesthesia event involved a medication or other substance (not including medical gas), please also submit as a “medication or other substance” event.

Responses Awareness (during anesthesia) Malignant hyperthermia Oversedation Physical injury Incorrect site anesthesia Difficulty managing airway Other (please describe)

Go-To Logic This question only appears if the event type is Anesthesia. If “other,” a text box for description will also open.

Required Yes, if event type is Anesthesia. Question Type Checkboxes Guide for Use Please see Appendix IV anesthesia event type definitions and common inclusions and

exclusions.

Was a briefing conducted prior to the induction of anesthesia? Question Location Event Tab – Additional Questions Section Description Determination of whether or not a pre-anesthesia briefing Prompt A “briefing” refers to phase 1 of a safe surgical/procedure checklist in which nursing staff and

anesthesia provider review the elements pertinent to the induction of anesthesia together. Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Anesthesia. If “Anesthesia event type” is “Physical injury,” opens the question “Type of physical injury.” If “Anesthesia event type” “Difficulty managing airway,” opens the question “Type of airway management problem.”

Required No Question Type Radio Buttons Guide for Use Relates to phase 1 of a safe surgical/procedure checklist in which nursing staff and anesthesia

provider review the elements together. Does not include a pre-anesthetic evaluation with the patient where procedures, alternatives, risks and questions (PARQ) are covered.


Type of physical injury Question Location Event Tab – Additional Questions Section Description Determination of what best characterizes the physical injury anesthesia event. Prompt Which physical injury best characterizes the outcome of the anesthesia event? Responses Dental injury

Ocular injury Peripheral nerve injury Other (please describe)

Go-To Logic This question only appears if the event type is Anesthesia. Only appears if “Anesthesia event type” is “Physical injury.” If “other,” a text box for description will also open.


Type of airway management problem Question Location Event Tab – Additional Questions Section Description Determination of the best characterization of the anesthesia adverse outcome of difficulty

managing airway. Prompt If there was an airway management problem, indicate type. Check all that apply Responses Difficulty during tracheal intubation

Difficulty maintaining airway during procedure Esophageal intubation Re-intubation, following unplanned/unintended extubation, in the operating or recovery room Other (please describe)

Go-To Logic This question only appears if the event type is Anesthesia. Only appears if “Anesthesia event type” is “Difficulty managing airway.” If “other,” a text box for description will also open.



Blood or Blood Product (Including Hemolytic Reactions) Event

Which best describes the event? Question Location Event Tab – Additional Questions Section Description Determination of the type of blood or blood product event. Prompt Check all that apply. Responses Adverse reaction

Incorrect patient Incorrect ABO/Rh type Incorrect product Incorrect sequence of administration of products Use of expired or unacceptably stored products Other (please describe)

Go-To Logic This question only appears if the event type is Blood or blood product event (including hemolytic reactions). If “other,” a text box for description will also open.

Required Yes, if event type is Blood or blood product event (including hemolytic reactions). Question Type Checkboxes Guide for Use Other blood or blood product

INCLUDES:

• Incorrect volume

• Incorrect IV fluid (i.e., administered product with incorrect IV fluid)

• Incorrect timing (e.g., delay in administration)

• Incorrect rate of administration

• Blood given without an order

Type of blood product involved Question Location Event Tab – Additional Questions Section Description Determination of what type of blood product was involved in the event. Prompt Indicate the type of blood product involved in the event. Responses Whole blood

Red blood cells Plasma Platelets Other (please describe)

Go-To Logic This question only appears if the event type is Blood or blood product event (including hemolytic reactions). If “other,” a text box for description will also open.

Required Yes, if event type is Blood or blood product event (including hemolytic reactions). Question Type Select Dropdown Guide for Use If more than one type of blood product was administered to the patient and you are unable

to assign involvement in the event to a single product type, select “Other” and specify all potentially-involved product types in the space provided. “Autologous blood salvage” should be considered an “other” blood product.

Was an independent double-check documented? Question Location Event Tab – Additional Questions Section Description Determination if documentation of an independent double-check for the blood product

involved was done. Prompt Please only include independent double-checks that were documented, performed by two

providers or staff immediately before administration of the blood or blood product, and


included verification of the patient’s identity, type of product, and expiration date of the product. Check one.

Responses Yes No Unknown

Go-To Logic This question only appears if the type of blood event is NOT Adverse reaction. Required No Question Type Radio Buttons Guide for Use In order to meet AHRQ Common Formats specifications for a “two-person three-way check

procedure,” the independent double-check must be specified in writing by the facility and must include, at a minimum, the following elements: A. The check must be performed by two persons, either jointly or one right after the other,

immediately before the blood product is administered to the patient. Each of the two must be either a healthcare professional or healthcare worker and be employed by, or on the staff of, the facility. Each must be familiar with the elements of the two-person three-way procedure.

B. The information checked must include 1) The patient's identity, including full name, sex, date of birth and medical record number; 2) the type of product ordered and the blood type and cross-match information, if relevant; and 3) the expiration date of the product.

C. The documentation checked for such information must include 1) the patient's identity band, 2) the label on the product, and 3) the requisition tag.

During which stage did the event originate (regardless of the stage when it was discovered)? Question Location Event Tab – Additional Questions Section Description During which process did the event originate (regardless of the stage when it was

discovered)? Prompt n/a Responses Product check-in

Product test or request Sample collection Sample handling Sample receipt Sample testing Product storage Available for issue Product selection Product manipulation Request for pickup Product issue Product administration (transfusion or infusion) Post-transfusion or administration Unknown Other (please describe)

Go-To Logic This question only appears if the type of blood event is NOT Adverse reaction. If “other,” a text box for description will also open.

Required No Question Type Select dropdown Guide for Use Product refers to the blood product involved in the event or unsafe condition.

Sample refers to the blood or tissue sample collected from the patient who is the prospective recipient of a blood product. Product check-in refers to processes relating to the receipt by Transfusion Services (Blood


Bank) of products (1) from an outside source or (2) from a patient care area for return to inventory. Product test or request refers to processes relating to an order by a clinical service for a test or product. Sample collection refers to processes relating to the collection of a blood or tissue sample from the patient. Sample handling refers to processes relating to the paperwork that is to accompany the sample to Transfusion Services for testing. Sample receipt refers to processes relating to the receipt of the sample by Transfusion Services. Sample testing refers to processes relating to the testing of the sample by Transfusion Services, such as type and crossmatch. Product storage refers to processes relating to the storage of products in Transfusion Services. Available for issue refers to processes relating to quality management of product inventory by Transfusion Services. Product selection refers to processes relating to the selection by Transfusion Services of products from inventory for transfusion. Product manipulation refers to processes relating to the pooling, irradiating, dividing, thawing and labeling of products by Transfusion Services. Request for pickup refers to processes relating to requests by clinical services for a product to be picked up for administration. Product issue refers to processes relating to the issuance of products from Transfusion Services Product administration refers to processes occurring between the time of receipt of the product by the patient care area until the product is administered to the patient, including storage, timing of administration, identification of patient, sequence of administration and equipment used for administration. Post-transfusion or administration refers to processes occurring after administration, such as stopping transfusion, monitoring and responding to adverse reactions in patient.


Contaminated Drugs, Devices or Biologics Event

Was the event reported to MedWatch? Question Location Event Tab – Additional Questions Section Description Determination of whether or not event was reported to the FDA’s voluntary reporting

system, MedWatch. Prompt Note: MedWatch is the Food and Drug Administration’s (FDA’s) voluntary reporting system

for an adverse events associated with the use of a medical product. Responses Yes

No Go-To Logic This question only appears if the event type is Contaminated drugs, devices, or biologics or

Device or medical/surgical supply (including use error). Required No Question Type Radio Buttons Guide for Use No further information provided.


Device or Medical/Surgical Supply (Including Use Error) Event

Was the event reported to MedWatch? Question Location Event Tab – Additional Questions Section Description Determination of whether or not event was reported to the FDA’s voluntary reporting

system, MedWatch. Prompt Note: MedWatch is the Food and Drug Administration’s (FDA’s) voluntary reporting system

for an adverse events associated with the use of a medical product. Responses Yes

No Go-To Logic This question only appears if the event type is Device or medical/surgical supply (including

use error) or Contaminated drugs, devices, or biologics. Required No Question Type Radio Buttons Guide for Use No further information provided.

Which best describes the event? Question Location Event Tab – Additional Questions Section Description Determination of the best description of the device or medical/surgical supply adverse event. Prompt Check all that apply. Responses Device or medical/surgical supply failure

Use error Device or supply not available Device or supply expired Other (please describe) Unknown

Go-To Logic This question only appears if the event type is Device or medical/surgical supply (including use error).

Required Yes, if event type is Device or medical/surgical supply (including use error). Question Type Checkboxes Guide for Use Device failure

INCLUDES:

• Parts falling off permanent equipment or equipment collapsing

• Programmed alarms failing to sound

• Equipment used after the end of its useful life

• Kinked tubing Use error INCLUDES:

• Use of incorrect instrument or equipment for task

• Misuse of the correct instrument or equipment (e.g., failing to lock the wheels on a wheelchair when assisting patient to stand; failing to program alarms to sound at correct times, locations; mis-setting an infusion pump for any reason)

• Reading scans on the wrong monitor Device or product not available INCLUDES:

• Equipment or medical/surgical supply unavailable in correct size

• Equipment or medical/surgical supply not stored in correct location Device or product expired INCLUDES:

• Non-surgical, non-implantable device passed its expiration date (e.g., glucose test strips)


Type of device or supply involved Question Location Event Tab – Additional Questions Section Description The type of device involved in the event. Prompt Select ‘Implantable device’ if the event involved the use or function of an implant. In events

involving both the use of function of an implant and an incorrect implant (e.g., incorrect side, size, expired), please also select ‘Surgical or other invasive procedure’ event from the ‘Event type’ list at the top of the page.

Responses Implantable device (e.g., device intended to be permanently inserted into tissue) Medical equipment (e.g., non-implantable device) Medical/surgical supply, including disposable product

Go-To Logic This question only appears if the event type is Device or medical/surgical supply (including use error).

Required Yes, if event type is Device or medical/surgical supply (including use error). Question Type Select Dropdown Guide for Use An Implantable device is a device that is intended to be permanently inserted into tissue.

A non-implantable device is a type of Medical equipment. Medical equipment is permanent and/or reusable. Medical/surgical supply is disposable or single use.

Specific device Question Location Event Tab Description Brief description of the specific device involved in the event. Prompt Briefly describe the specific device involved in the event. Go-To Logic This question only appears if the event type is Device or medical/surgical supply (including

use error). Required No Question Type Text Input Maximum length 128 characters Guide for Use No further information provided.


Fall Event

Was a fall risk assessment documented? Question Location Event Tab – Additional Questions Section Description Determination if the patient was at assessed to be risk for a fall. Prompt Please note: this refers to assessments performed prior to the fall. Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Fall. Required No Question Type Radio Buttons Guide for Use Select “yes” if there is any fall risk assessment documented in the patient's medical record

prior to the fall. Any type of fall risk assessment will qualify. Documented fall precautions will also qualify if they are only put in place if the patient is assessed to be a fall risk.

Was the patient assessed to be at any level of risk for a fall? Question Location Event Tab – Additional Questions Section Description Determination if the patient was at risk for a fall. Prompt n/a Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Fall. Required Yes Question Type Radio Buttons Guide for Use Enter the determination from the risk assessment made prior to the fall. Many fall risk

assessments use a scale of risk. Answer “yes” if the patient was found to be at any level of risk.

Date of most recent fall risk assessment Question Location Event Tab – Additional Questions Section Description Determine the date of the most recent fall risk assessment Prompt n/a Go-To Logic This question only appears if the event type is Fall. Required Yes Question Type Date

Format mm/dd/yyyy Guide for Use Provide the date of the most recent fall risk assessment completed prior to the patient fall.

This includes (but is not limited to) assessments completed on admission, in response to a change in the patient’s condition, or as part of a standardized reassessment process (e.g., reassessing patient’s fall risk quarterly).

Why was the most recent fall assessment performed? Question Location Event Tab – Additional Questions Section Description Determination of when the patient/resident was most recently assessed for fall risk. Prompt Please note: this refers to assessments performed prior to the fall. Responses New patient/resident assessment

Quarterly assessment period Change of condition Routine or daily shift assessment


Unknown Other (please describe)

Go-To Logic This question only appears if the event type is Fall and if a fall risk assessment was documented. If “other,” a text box for description will also open.

Required Yes Question Type Radio Buttons Guide for Use No further information provided.

Was the patient on medication known to increase fall risk at the time of the fall? Question Location Event Tab – Additional Questions Section Description Determination if the patient was on medication known to increase the risk for a fall. Prompt Include drug interactions. Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Fall. If “yes”, opens the question “Was the medication considered to have contributed to the fall?”

Required Yes Question Type Radio Buttons Guide for Use Mark this question “yes” if the patient:

• Was on narcotics, hypnotics, psychotropics, sedatives, and/or any other medication or substance known to increase fall risk

o This includes known idiosyncratic reactions to drugs that are not commonly associated with increased fall risk (e.g. antihistamines, antihypertensives, anti-seizure/antiepileptics, cathartics, diuretics, hypoglycemic agents, etc.)

• Had a drug interaction producing symptoms likely to increase fall risk

• Recently received anesthesia or epidural injections


Was the medication considered to have contributed to the fall? Question Location Event Tab – Additional Questions Section Description Determination if the medication was considered to have contributed to the fall. Prompt n/a Responses Yes

No Unknown

Go-To Logic This question only appears if “Was the patient on medication known to increase fall risk at the time of the fall?” was answered “yes.” If “yes,” a text box for description will also open.

Required Yes Question Type Radio Buttons Guide for Use Select “Yes” if the patient was on any medications that contributed to the fall. Select “Unknown” if it is

not known if the medication contributed to the fall and “No” if the medication did not contribute to the fall.

Were any of the following risk factors present at the time of the fall? Question Location Event Tab – Additional Questions Section Description Determination of risk factors present at the time of the fall. Prompt Check all that apply Responses Cognitive impairment

History of previous fall Mobility or gait impairment Prosthesis or specialty/prescription shoe Sensory impairment (vision, hearing, balance, etc.) Patient on five or more medications None Unknown Other (please describe)

Go-To Logic This question only appears if the event type is Fall. If “other,” a text box for description will also open.

Required Yes Question Type Checkboxes Guide for Use No further information provided.

Were any of the following risk factors considered to have CONTRIBUTED to the fall? Question Location Event Tab – Additional Questions Section Description Determination of risk factors present at the time of the fall that contributed to the fall. Prompt Check all that apply Responses Cognitive impairment

History of previous fall Mobility or gait impairment Prosthesis or specialty/prescription shoe Sensory impairment (vision, hearing, balance, etc.) Patient on five or more medications None Unknown Other (please describe)


Required Yes


Question Type Checkboxes Guide for Use No further information provided.

Which of the following were in the patient’s care plan to prevent falls? Question Location Event Tab – Additional Questions Section Description Fall prevention protocols or interventions in the patient’s care plan at the time of the fall. Prompt Indicate all protocols/interventions that were in the patient’s care plan. Check all that apply. Responses Alarms (e.g., bed, chair, tab)

Assistive devices (e.g., wheelchair, commode, cane, crutches, scooter, walker) Bed in low position Call light/personal items within reach Change in medication Fall alert Hip and/or joint protectors Identified as a high fall risk Intentional rounding Non-slip floor mats Non-slip footwear Patient and family education Patient situated close to the nurses' station Physical/occupational therapy Physical/occupational therapy (including exercise or mobility program) Siderails or assist rails Sitter Supplemental, environmental or area lighting (when usual facility lighting is considered insufficient) Toileting regimen None Unknown Other (please describe)

Go-To Logic This question only appears if the event type is Fall. Required Yes Question Type Checkboxes Guide for Use Answer this question even if no fall risk assessment was performed prior to the fall. Select

each fall risk protocol/intervention that was in the patient’s care plan to prevent falls. Please note: not all protocols/interventions in this list are currently considered best practice, and only individuals qualified by the facility may be considered a “sitter” for the purpose of a fall prevention care plan.

Which of the following were in place and being used to prevent falls for this patient? Question Location Event Tab – Additional Questions Section Description Fall prevention protocols or interventions in use at the time of the fall. Prompt Indicate all protocols/interventions that were in the patient’s care plan. Check all that apply. Responses Alarms (e.g., bed, chair, tab)

Assistive devices (e.g., wheelchair, commode, cane, crutches, scooter, walker) Bed in low position Call light/personal items within reach Change in medication Fall alert Hip and/or joint protectors Identified as a high fall risk


Intentional rounding Non-slip floor mats Non-slip footwear Patient and family education Patient situated close to the nurses' station Physical/occupational therapy Physical/occupational therapy (including exercise or mobility program) Siderails or assist rails Sitter Supplemental, environmental or area lighting (when usual facility lighting is considered insufficient) Toileting regimen None Unknown Other (please describe)

Go-To Logic This question only appears if the event type is Fall. Required Yes Question Type Checkboxes Guide for Use Answer this question even if no fall risk assessment was performed prior to the fall. Select

each fall risk protocol/intervention that was being used to prevent falls for the patient who fell. Do not select interventions that, although required or recommended by a care plan or protocol, were not in place or being used at the time of the fall. Please note: not all protocols/interventions in this list are currently considered best practice, and only individuals qualified by the facility may be considered a "sitter" for the purpose of a fall prevention care plan. If a patient, family member or staff has removed an intervention, please consider it “not in use.”

Prior to the fall, what was the patient doing or trying to do? Question Location Event Tab – Additional Questions Section Description Determination of the action the patient was doing or trying to do prior to the fall. Prompt n/a Responses Walking with assistance and/or with an assistive device or medical equipment

Walking without assistance and without an assistive device or medical equipment Changing position (e.g., in bed, chair, etc.) Dressing or undressing Navigating bedrails/siderails/assist rails Reaching for an item Showering or bathing Toileting-related activities Transferring to or from bed, chair, wheelchair, etc. with assistance Transferring to or from bed, chair, wheelchair, etc. without assistance Undergoing a diagnostic or therapeutic procedure Sleeping Standing or sitting Wheeling in wheelchair or scooter Unknown


Required Yes Question Type Select Dropdown Guide for Use See the PSRP Corner article on this topic: https://oregonpatientsafety.org/blog/psrp-

https://oregonpatientsafety.org/blog/psrp-corner/what-is-the-correct-activity-for-a-fall/655


corner/what-is-the-correct-activity-for-a-fall/655

What was the patient’s goal? Why did s/he get up or try to get up? Question Location Event Tab – Additional Questions Section Description Determination of the patient’s goal before the fall. Prompt Check all that apply. Responses Relieve hunger or thirst

Adjust controls in the environment (e.g., TV volume, heat) Change location (e.g., move to another room, different chair) Exercise (e.g., PT/OT) Retrieve a personal item (e.g., TV remote, cigarettes, clothing, medication) Return to bed or chair Toileting Unknown Other (please describe)


Required Yes Question Type Checkboxes Guide for Use No further information provided.

Was the fall observed? Question Location Event Tab – Additional Questions Section Description Determination on whether the fall was observed. Prompt n/a Responses Yes – by staff

Yes – by visitor, family or another patient, but not staff No Unknown

Go-To Logic This question only appears if the event type is Fall. Required Yes Question Type Radio Buttons Guide for Use A fall is observed if another person saw the patient reach the ground or other unintended

surface. An assisted fall is inherently an observed fall.

Was the fall assisted or unassisted? Question Location Event Tab – Additional Questions Section Description Determination if the fall was unassisted or assisted Prompt n/a Responses Assisted

Unassisted Unknown

Go-To Logic This question only appears if the event type is Fall. Required Yes Question Type Radio Buttons Guide for Use An assisted fall occurs when the patient begins to fall, is assisted by another person, but

nevertheless reaches the ground or other unintended surface.

Did any physical device contribute to the fall? Question Location Event Tab – Additional Questions Section Description Determination of whether or not a physical device contributed to the fall. Prompt Includes restraints, bedrails, and tripping over device electrical power cords, IV tubes, etc.

https://oregonpatientsafety.org/blog/psrp-corner/what-is-the-correct-activity-for-a-fall/655


Responses Yes No Unknown

Go-To Logic This question only appears if the event type is Fall. Required No Question Type Radio Buttons Guide for Use Choose “yes” if assistive devices (e.g. wheelchair, commode, cane, crutches, scooter, walker)

restraints, bedrails or another physical device actively contributed to the fall. Do not choose “yes” if the absence of a physical device contributed to the fall.

What was the physical or environmental cause of the fall? Question Location Event Tab – Additional Questions Section Description Determine if a physical or environmental factor caused the fall. Prompt Check all that apply Responses Legs or knees “gave out” or stiffened suddenly

Loss of balance or footing Loss of consciousness Patient condition (e.g., TIA, seizure) Device or equipment (e.g., walker rolled forward, wheelchair footrest broke) Fell out of bed (e.g., rolled out of bed, slipped off a slippery mattress) Slip or trip Tangled in cords, tubing, or similar Unknown Other (please describe)


Required Yes Question Type Checkboxes Guide for Use Physical causes include the individual (e.g., loss of balance, seizures, etc.) whereas

environmental causes include the surrounding environment (e.g., patient was tangled in cords, slipped on wet floor, etc.)

Did the patient sustain a physical injury as a result of the fall? Question Location Event Tab – Additional Questions Section Description Determination if the patient sustained a physical injury as a result of the fall. Prompt n/a Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Fall. If “yes,” opens the question “What type of injury was sustained?”

Required Yes Question Type Radio Buttons Guide for Use No further information provided.

What type of injury was sustained? Question Location Event Tab – Additional Questions Section Description Determination of the type of injury sustained as a result of the fall. Prompt If more than one, choose most severe. Responses Dislocation

Fracture Intracranial injury


Laceration requiring sutures Skin tear, avulsion, hematoma or significant bruising Abrasion or laceration not requiring sutures Other (please describe)

Go-To Logic This question only appears if “Did the patient sustain a physical injury as a result of the fall?” was answered “yes.” If “other,” a text box for description will also open.

Required Yes Question Type Select Dropdown Guide for Use If the patient sustained more than one type of injury as a result of the fall, select the injury

which in your judgment caused the greatest harm to the patient. You may wish to refer to Appendix II: Harm Categories and Algorithm in arriving at your determination.

Healthcare-Associated Infection (HAI) Event

Type of healthcare-associated infection (HAI) Question Location Event Tab – Additional Questions Section Description Determination of what type of HAI is being reported. Prompt Check all that apply. Responses Eye, ear, nose, throat, or mouth infection

Gastrointestinal system infection Lower respiratory tract infection (other than pneumonia) Primary blood stream infection (BSI) Central line-associated BSI (CLABSI) Pneumonia Ventilator-associated Pneumonia (VAP) Sepsis Surgical site infection (SSI) Urinary tract infection (UTI) Catheter-associated UTI (CAUTI) Other (please describe)

Go-To Logic This question only appears if the event type is Healthcare-associated infection (HAI). If the type of HAI is Surgical site infection (SSI), opens the question “SSI site.” If the type of HAI is Central line associated BSI (CLABSI), opens the question “Type of central line involved.” If “other,” a text box for description will also open.

Required Yes, if event type is Healthcare-associated infection (HAI). Question Type Checkboxes Guide for Use Please see Appendix V for Healthcare-associated infection event type definitions.

“Aspiration pneumonia” should be submitted as both an Aspiration and Pneumonia (HAI event).

Was the infection determined to be present or incubating on admission? Question Location Event Tab – Additional Questions Section Description Determination if the infection was present or incubating on admission. Prompt n/a Responses No

Yes – infection was related to a previous admission at this facility Yes – infection was determined to be present or incubating on admission Unknown


Go-To Logic This question only appears if the event type is Healthcare-associated infection (HAI). Required Yes, if event type is Healthcare-associated infection (HAI). Question Type Select Dropdown Guide for Use Select the most appropriate “Yes” response if the professional(s) responsible for making this

determination at your facility have determined that the infection you are reporting was present or incubating on admission. Select “No” if the determination was that the infection developed during the admission. If no conclusive determination has been made, or you do not know what the determination is, select “Unknown”.

Type of pathogen Question Location Event Tab – Additional Questions Section Description Determination of pathogen involved in HAI event. Prompt n/a Responses C. diff (Clostridium difficile)

CRE (Carbapenem-Resistant Enterobacteriaceae) E. coli (Escherichia coli) Fungal (including candida) MRSA (Methicillin-resistant Staphylococcus aureus) MSSA (Methicillin-sensitive Staphylococcus aureus) Other Staph aureus VRE (Vancomycin-Resistant Enterococci) Other Unknown

Go-To Logic This question only appears if the event type is Healthcare-associated infection (HAI). Required No Question Type Select Dropdown Guide for Use Pathogen type must be verified by a culture. If a positive culture was not obtained, select

“unknown.”

SSI site Question Location Event Tab – Additional Questions Section Description Brief description of the site on the body of the SSI. Prompt Briefly describe the site on the body of the SSI. Go-To Logic This question only appears if the type of HAI is Surgical site infection (SSI). Required Yes, if the type of HAI is Surgical site infection (SSI). Question Type Text input Guide for Use No further information provided.

Type of central line involved Question Location Event Tab – Additional Questions Section Description Determination of the type of central line involved in the central line-associated bloodstream

infection. Prompt n/a Responses Permanent/long-term (tunneled or implanted) central line

Temporary (non-tunneled or PICC) central line Umbilical catheter Unknown

Go-To Logic This question only appears if the type of HAI is Central line associated BSI (CLABSI). Required Yes Question Type Select Dropdown Guide for Use A “permanent central line” is a central line that is tunneled, including certain dialysis


catheters and implantable central line catheters (including ports). A “temporary central line” is a central line that is not tunneled, including PICC lines. An “umbilical catheter” is a central line inserted through the umbilical artery or vein in a neonate.


Maternal Event

Gestational age (weeks) Question Location Event Tab - maternal section Description The gestational age prior to delivery - weeks. Prompt Immediately prior to delivery, or at the time of the intrauterine procedure (prenatal), what

was the best estimate of completed weeks of gestation (in weeks and days)? Go-To Logic This question only appears if the event type is Maternal or Perinatal. Required No Question Type Text input Minimum Value 20 Maximum Value 45 Guide for Use No further information provided.

Gestational age (days) Question Location Event Tab - maternal section Description The gestational age prior to delivery - days. Prompt n/a Go-To Logic This question only appears if the event type is Maternal or Perinatal Required No Question Type Text input Minimum Value 0 Maximum Value 6 Guide for Use No further information provided.

Was labor induced or augmented? Question Location Event Tab - maternal section Description Determination if labor was either induced or augmented. Prompt n/a Responses Induced

Augmented Neither Unknown

Go-To Logic This question only appears if the event type is Maternal or Perinatal Required No Question Type Radio Buttons Guide for Use Induction is a method of artificially or prematurely stimulating childbirth in a woman.

Augmentation is the process of facilitating further labor and includes, but is not limited to, the use of Oxytocin (Pitocin). Select 'Unknown' if you do not know whether the mother's labor was induced or augmented, or if you do not know which of those two methods was used.

What was the final mode of delivery? Question Location Event Tab - maternal section Description Determination of the final mode of delivery. Prompt n/a Responses Vaginal delivery

Attempted vaginal delivery followed by Cesarean section Cesarean section Unknown

Go-To Logic This question only appears if the event type is Maternal or Perinatal


Required No Question Type Radio Buttons Guide for Use No further information provided.

Did the delivery involve the following? Question Location Event Tab - maternal section Description Determination if the delivery involved episiotomy, vacuum, forceps, or shoulder dystocia. Prompt Check all that apply Responses Episiotomy

Vacuum Forceps Shoulder dystocia

Go-To Logic This question only appears if the event type is Maternal or Perinatal Required No Question Type Checkboxes Guide for Use No further information provided.

Which adverse outcome(s) did the mother sustain? Question Location Event Tab - maternal section Description The adverse outcome(s) sustained by the mother. Prompt Check all that apply. Responses Bladder injury

Bowel injury Chorioamnionitis Death Eclampsia Endometritis Hemorrhage requiring transfusion Hemorrhage requiring treatment other than transfusion Magnesium toxicity Ureter injury Uterine rupture 3rd or 4th degree perineal laceration None Other (please describe)

Go-To Logic This question only appears if the event type is Maternal. If “other,” a text box for description will also open.

Required No Question Type Checkboxes Guide for Use If the injury was to the uterus but was not a rupture, or if it was a perineal laceration that was

less than third degree, select “Other.”


Medication or Other Substance Event

Type of medication or other substance event Question Location Event Tab – Additional Questions Section Description Determination of the type of medication or other substance event. Prompt Check all that apply. Responses Incorrect medication or substance

Incorrect route Incorrect dosage form Incorrect strength Incorrect dose Incorrect rate Incorrect time Expired medication or substance Incorrect/incomplete labeling Medication or substance contraindicated (includes documented allergies and sensitivities) Medication or substance discontinued Medication or substance omitted Allergic reaction due to unknown allergy Adverse reaction not due to allergy or known contraindication Drug interaction Oversedation Other (please describe)

Go-To Logic This question only appears if the event type is Medication or other substance. If “other,” a text box for description will also open.

Required Yes, if event type is Medication or other substance. Question Type Checkboxes Guide for Use Please see Appendix IV: Medication or Other Substance Event Type Descriptions for definitions

and common inclusions and exclusions. You may also want to refer to the PSRP Corner article on this topic (https://oregonpatientsafety.org/blog/blog/how-do-i-classify-my-medication-related-adverse-event/735/). In keeping with NQF, hypoglycemia is considered a harm resulting from a medication event.

What type of medication/substance was involved? Question Location Event Tab – Additional Questions Section Description Determination of the type of medication/substance involved in the event. Prompt Check all that apply. Responses Prescription or over-the-counter (including herbal supplements)

Compounded preparation Investigational drug Other substance Unknown

Go-To Logic This question only appears if the event type is Medication or other substance. If “Other substance,” opens the question “Type of other substance.”

Required No Question Type Select Dropdown Guide for Use A medication is a type of drug.

Prescription or over-the-counter medications are available commercially in final form. This includes products containing chlorhexidine gluconate (CHG). Compounded preparations require the intercession of an authorized compounder and are not available off the shelf. They are prepared by mixing two or more drugs or compounds, thus the name.

https://oregonpatientsafety.org/blog/blog/how-do-i-classify-my-medication-related-adverse-event/735/

https://oregonpatientsafety.org/blog/blog/how-do-i-classify-my-medication-related-adverse-event/735/


Investigational drugs, as used here, are drugs that have not yet been approved for marketing by the Food and Drug Administration (FDA) and are not freely available to the public. They are available only as part of a clinical trial, for emergency use, or for serious or life-threatening conditions prior to completion of final clinical work and FDA review. Other substance includes biological products (e.g. vaccines, thrombolytics); nutritional products (e.g. dietary supplements; vitamins or minerals; enteral nutritional products, including infant formula; parenteral nutritional products); expressed human breast milk; contrast media; radiopharmaceuticals; patient food.

Type of other substance Question Location Event Tab – Additional Questions Section Description Determination of the type of medication/substance involved in the event. Prompt Medical gases should be submitted as a “Contaminated, no or wrong gas given to a patient”

event. Graft tissue should be submitted as a “device or medical/surgical supply” event. Responses Biological products (including vaccines)

Nutritional products Expressed human breast milk Contrast media Radiopharmaceuticals Patient food Other (please describe)

Go-To Logic This question only appears if “What type of medication/substance was involved?” was answered “Other substance.” If “other,” a text box for description will also open.

Required No Question Type Select Dropdown Guide for Use A biological product means any virus, therapeutic serum, toxin, antitoxin, or analogous

product applicable to the prevention, treatment or cure of disease or injury. A nutritional product, for the purposes of this form, does not include "conventional" food. Expressed human breast milk is human breast milk that was produced by manipulating the lactating breast, either by hand or with a breast pump. Contrast media constitute a type of drug. They are used to enhance the contrast of structures or fluids within the body during medical imaging. A radiopharmaceutical is a radioactive chemical or pharmaceutical preparation that is labeled with a radionuclide in tracer or therapeutic concentration and this is used as a diagnostic or therapeutic agent.

Generic name or investigational drug name Question Location Event Tab – Additional Questions Section Description Identification of the generic name or investigational drug name of the product involved in the

event. Prompt n/a Go-To Logic This question only appears if the event type is Medication or other substance. Required No Question Type Text Input

There are five rows available for up to 5 medications or other substances that may have been involved in this event.

Guide for Use No further information provided.

Was this medication/substance prescribed for this patient? Question Location Event Tab – Additional Questions Section Description Determination of the medication/substance prescribed for this patient.


Prompt n/a Responses Yes

No Go-To Logic This question only appears if the event type is Medication or other substance. Required No Question Type Radio Buttons


Guide for Use Do not include information about compounded preparations or expressed breast milk when responding.

Was this medication/substance given to this patient? Question Location Event Tab – Additional Questions Section Description Determination if the medication/substance was given to this patient. Prompt n/a Responses Yes

No Go-To Logic This question only appears if the event type is Medication or other substance. Required No Question Type Radio Buttons


Guide for Use Do not include information about compounded preparations or expressed breast milk when responding.

At what stage in the process did the event originate, regardless of the stage at which it was discovered? Question Location Event Tab – Additional Questions Section Description The stage in the process the event originated. Prompt n/a Responses Purchasing

Storing Prescribing/ordering Transcribing Preparing Dispensing (includes labeling) Administering Monitoring Unknown Other (please describe)

Go-To Logic This question only appears if the event type is Medication or other substance. If “other,” a text box for description will also open.

Required No Question Type Select Dropdown Guide for Use Purchasing includes purchasing for stock or for a particular patient.

Storing includes maintaining the substance under special environmental conditions and in accordance with appropriate security requirements. Prescribing/ordering means the issuance of an order by an authorized professional for the delivery or administration of a substance to a patient. This may be done in writing, verbally or through an electronic order entry system. Transcribing includes documenting verbal orders in writing or electronically, entering written orders into an electronic system and copying orders for separate uses.


Preparing includes taking substances from stock, manipulating them, compounding, and measuring and apportioning doses, such as the filling of cartridges and unit-dose syringes. Dispensing includes assuring accurate labeling of the prepared substance, issuance of the substance from the pharmacy, and delivery by pharmacy personnel to the patient care area. Administering generally occurs in a patient care area and includes checking orders and patient identity and delivering the substance to the patient either by oral ingestion or by direct application (e.g., injection, insertion, or topical application) or with the use of indwelling lines, tubes or catheters. Monitoring includes measuring and observing to determine the presence or absence of the desired effect of the substance administered and to detect any unintended adverse effects. If a Medication or substance discontinued event occurs because the pharmacy makes the error, it originated at dispensing. If the order is missed, it originated at prescribing. Otherwise, a discontinuation originates at administration. If an extra dose of medication is given, the event originates in administration. If the scheduler did not write room orders correctly, the event originates in transcription. Manufacturer labeling errors originate at other. If and errors occurs at a patient’s home because of inadequate instruction to the patient, the event originates at administering.

Were any of the following involved? Question Location Event Tab – Additional Questions Section Description Additional medication event-specific contributing factors. Prompt Check all that apply. Responses Look-alike/sound-alike drugs

Two or more prescriptions filled at the same time Medications administered to two or more patients at the same time

Go-To Logic This question only appears if the event type is Medication or other substance. Required No Question Type Checkboxes Guide for Use No further information provided.

What was the contraindication (potential or actual interaction)? Question Location Event Tab – Additional Questions Section Description The determination of a contraindication (potential or actual interaction) to the administration

of a medication or substance to which a patient was known to have allergies or sensitivities. Prompt n/a Responses Documented allergy or sensitivity

Drug-drug Drug-food Drug-disease Other contraindication (please describe)

Go-To Logic This question only appears if the type of “Type of medication or other substance event” is “Medication or substance contraindicated (includes documented allergies and sensitivities).” If “other,” a text box for description will also open.

Required No Question Type Select dropdown Guide for Use No further information provided.

What was the intended route of administration? Question Location Event Tab – Additional Questions Section Description Determination of the intended route of administration. Prompt n/a


Responses Cutaneous, topical application, including ointment, spray, patch Subcutaneous Ophthalmic Oral, including sublingual or buccal Otic Nasal Inhalation Intravenous Intramuscular Intrathecal Epidural Gastric Rectal Vaginal Unknown Other (please describe below)

Go-To Logic This question only appears if the type of “Type of medication or other substance event” is “Incorrect route.” If “other,” a text box for description will also open.


What was the actual route of administration? Question Location Event Tab – Additional Questions Section Description The actual route of administration if the event involved an incorrect route of administration. Prompt Includes attempted and completed. Responses Cutaneous, topical application, including ointment, spray, patch

Subcutaneous Ophthalmic Oral, including sublingual or buccal Otic Nasal Inhalation Intravenous Intramuscular Intrathecal Epidural Gastric Rectal Vaginal Unknown Other (please describe below)

Go-To Logic This question only appears if the type of “Type of medication or other substance event” is “Incorrect route.” If “other,” a text box for description will also open.



Perinatal Event

Gestational age (weeks) Question Location Event Tab - perinatal section Description The gestational age prior to delivery - weeks. Prompt Immediately prior to delivery, or at the time of the intrauterine procedure (prenatal), what

was the best estimate of completed weeks of gestation (in weeks and days)? Go-To Logic This question only appears if the event type is Perinatal or Maternal. Required No Question Type Text input Minimum Value 20 Maximum Value 45 Guide for Use No further information provided.

Gestational age (days) Question Location Event Tab - perinatal section Description The gestational age prior to delivery - days. Prompt n/a Go-To Logic This question only appears if the event type is Perinatal or Maternal. Required No Question Type Text input Minimum Value 0 Maximum Value 6 Guide for Use No further information provided.

Was labor induced or augmented? Question Location Event Tab - perinatal section Description Determination if labor was either induced or augmented. Prompt n/a Responses Induced

Augmented Neither Unknown

Go-To Logic This question only appears if the event type is Perinatal or Maternal. Required No Question Type Radio Buttons Guide for Use Induction is a method of artificially or prematurely stimulating childbirth in a woman.

Augmentation is the process of facilitating further labor and includes, but is not limited to, the use of Oxytocin (Pitocin). Select 'Unknown' if you do not know whether the mother's labor was induced or augmented, or if you do not know which of those two methods was used.

What was the final mode of delivery? Question Location Event Tab - perinatal section Description Determination of the final mode of delivery. Prompt n/a Responses Vaginal delivery

Attempted vaginal delivery followed by Cesarean section Cesarean section Unknown

Go-To Logic This question only appears if the event type is Perinatal or Maternal.



Did the delivery involve the following? Question Location Event Tab - perinatal section Description Determination if the delivery involved episiotomy, vacuum, forceps, or shoulder dystocia. Prompt Check all that apply Responses Episiotomy

Vacuum Forceps Shoulder dystocia

Go-To Logic This question only appears if the event type is Perinatal or Maternal. Required No Question Type Checkboxes Guide for Use No further information provided.

Did the event affect a fetus or a neonate? Question Location Event Tab - perinatal section Description The patient affected by the perinatal event. Prompt Check all that apply. Responses Fetus

Neonate Go-To Logic This question only appears if the event type is Perinatal.

If “fetus,” opens the question “Which adverse outcome did the fetus sustain?” If “neonate,” opens the questions “Neonate's birthweight,” “What was the neonate’s 5-minute Apgar score?” and “Which adverse outcome(s) did the neonate sustain?”

Required Yes, if event type is Perinatal. Question Type Radio buttons Guide for Use If the event was a stillbirth, select fetus unless resuscitation was attempted and successful

regardless of the outcome, then select neonate. If the event involved more than one fetus or neonate, please submit a separate report for each affected. A fetus is a developing human, nine weeks after fertilization and before birth. A neonate is an infant after birth to one month of age. Neonate includes any live-born infant (i.e., premature infants, postmature infants, and full term infants).

Which adverse outcome did the fetus sustain? Question Location Event Tab - perinatal section Description Determination of what adverse outcome was sustained by the fetus. Check first applicable. Prompt If "unexpected death" occurred after an injury, please select "injury." Responses Injury

Unexpected death Go-To Logic This question only appears if the question “Did the event affect a fetus or a neonate?” was

answered “fetus.” Required No Question Type Radio Buttons Guide for Use No further information provided.


Neonate's birthweight Question Location Event Tab - perinatal section Description Neonate's birthweight entered in grams. Prompt In grams. Go-To Logic This question only appears if the question “Did the event affect a fetus or a neonate?” was

answered “neonate.” Required No Question Type Number Minimum Value 500 Maximum Value 9000 Guide for Use If there was more than one neonate involved in the event, enter the birthweight of the

heaviest infant affected.

What was the neonate’s 5-minute Apgar score? Question Location Event Tab - perinatal section Description The Apgar score at five minutes. Prompt n/a Go-To Logic This question only appears if the question “Did the event affect a fetus or a neonate?” was

answered “neonate.” Required No

Will only accept whole numbers between 0 and 10. Question Type Number Minimum Value 0 Maximum Value 10 Guide for Use No further information provided.

Which adverse outcome(s) did the neonate sustain? Question Location Event Tab - perinatal section Description Adverse outcome sustained by the neonate. Prompt Check all that apply. Responses Anoxic or hypoxic encephalopathy

Infection (e.g. group B strep) Injury to brachial plexus Seizure(s) Subdural or cerebral hemorrhage Unexpected death Other (please describe)

Go-To Logic This question only appears if the question “Did the event affect a fetus or a neonate?” was answered “neonate.” If “other,” a text box for description will also open.

Required No Question Type Checkboxes Guide for Use Anoxic or hypoxic encephalopathy is a condition in which brain tissue is deprived of oxygen

and there is global loss of function. A brachial plexus injury is an injury to the brachial plexus — the network of nerves that sends signals from your spine to your shoulder, arm and hand


Pressure Ulcer Event

Most advanced stage of pressure ulcer being reported Question Location Event Tab – Additional Questions Section Description Determination of the most advanced stage of the pressure ulcer or suspected deep tissue

injury being reported. Prompt n/a Responses Stage 1

Stage 2 Stage 3 Stage 4 Unstageable Suspected deep tissue injury Unknown

Go-To Logic This question only appears if the event type is Pressure ulcer. Required No Question Type Select Dropdown Guide for Use Note: Pressure ulcers Stage III and above are always permanent harm.

Select Stage 1 if the most advanced stage of the skin lesion being reported was intact skin with non-blanchable redness of a localized area usually over a bony prominence. Select Stage 2 if the most advanced stage of the skin lesion being reported was partial-thickness tissue loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. Select Stage 3 if the most advanced stage of the skin lesion being reported was full-thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon or muscles are not exposed. Select Stage 4 if the most advanced stage of the skin lesion being reported was full-thickness tissue loss with exposed bone, tendon or muscle. Select Unstageable if the most advanced stage of the skin lesion being reported was full-thickness tissue loss in which the base of the ulcer is covered by slough and/or eschar in the wound bed. Select Suspected Deep Tissue Injury if the most advanced stage of the skin lesion being reported was a purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear.

What was the stage of the pressure ulcer on admission? Question Location Event Tab – Additional Questions Section Description Determination of the status of the existing pressure ulcer on admission to the facility. Prompt n/a Responses Not present

Stage 1 Stage 2 Stage 3 Stage 4 Unstageable Suspected deep tissue injury Unknown

Go-To Logic This question only appears if the event type is Pressure ulcer. Required No Question Type Select Dropdown Guide for Use Select Stage 1 if, on admission, the stage of the skin lesion being reported was intact skin with

non-blanchable redness of a localized area usually over a bony prominence. Select Stage 2 if, on admission, the stage of the skin lesion being reported was partial-


thickness tissue loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. Select Stage 3 if, on admission, the stage of the skin lesion being reported was full-thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon or muscles are not exposed. Select Stage 4 if, on admission, the stage of the skin lesion being reported was full-thickness tissue loss with exposed bone, tendon or muscle. Select Unstageable if, on admission, the stage of the skin lesion being reported was full-thickness tissue loss in which the base of the ulcer is covered by slough and/or eschar in the wound bed. Select Suspected Deep Tissue Injury if, on admission, the stage of the skin lesion being reported was a purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear.

Pressure ulcer location on the body Question Location Event Tab – Additional Questions Section Description Location of the pressure ulcer on the body. Prompt Check all that apply to the specific ulcer being reported. Responses Ankle

Back Back of head Buttock Coccyx Elbow Heel Hip Knee Sacrum Shoulder Thigh Other (please describe)

Go-To Logic This question only appears if the event type is Pressure ulcer. If “other,” a text box for description will also open.


On admission to the facility, was a skin inspection documented? Question Location Event Tab – Additional Questions Section Description Documentation of a skin inspection done on admission to this facility. Prompt Check one. Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Pressure ulcer. Required No Question Type Radio Buttons Guide for Use Select Yes if a skin inspection was documented on admission to the facility in accordance with

facility’s internal Policies & Procedures. Select No if there was no documentation of an admission skin inspection performed in accordance with the facility's internal Policies & Procedures.


When was the first pressure ulcer risk assessment documented? Question Location Event Tab – Additional Questions Section Description Determination of when the first pressure ulcer risk assessment was performed Prompt n/a Responses On admission (within 24 hours)

Not on admission, but documented prior to the discovery of a newly-developed, or advancement of an existing, pressure ulcer Not on admission, but documented after discovery of a newly-developed, or advancement of an existing, pressure ulcer No risk assessment documented Unknown

Go-To Logic This question only appears if the event type is Pressure ulcer. If “On admission (within 24 hours) or “Not on admission, but documented prior to the discovery of a newly-developed, or advancement of an existing, pressure ulcer,” opens the questions “Type of risk assessment performed” and “Was the patient assessed to be at any level of risk for a pressure ulcer?”


Type of risk assessment performed Question Location Event Tab – Additional Questions Section Description Determination of the type of risk assessment used. Prompt n/a Responses Clinical assessment

Braden/Braden Q Other formal assessment tool Unknown

Go-To Logic This question only appears if “When was the first pressure ulcer risk assessment documented?” was answered “On admission (within 24 hours) or “Not on admission, but documented prior to the discovery of a newly-developed, or advancement of an existing, pressure ulcer.”

Required No Question Type Select Dropdown Guide for Use Answer this question only if a pressure ulcer risk assessment was performed prior to the

discovery of a new, or the advancement of an existing, pressure ulcer or suspected deep tissue Injury. Select Clinical assessment if the type of risk assessment performed was based on a clinical evaluation but was not based on a published formal scale or score. Select Other formal assessment tool if the type of risk assessment performed was a formal assessment, such as one involving a score or scale that has been published, tested and validated but was not the Braden/Braden Q (e.g., Norton, Waterlow, etc.).

Was the patient assessed to be at any level of risk for a pressure ulcer? Question Location Event Tab – Additional Questions Section Description Determination if the patient was documented to be at increased risk for pressure ulcer as a

result of the risk assessment. Prompt n/a Responses Yes

No Unknown

Go-To Logic This question only appears if “When was the first pressure ulcer risk assessment


documented?” was answered “On admission (within 24 hours) or “Not on admission, but documented prior to the discovery of a newly-developed, or advancement of an existing, pressure ulcer.”

Required No Question Type Select Dropdown Guide for Use Answer this question only if a pressure ulcer risk assessment was performed prior to the

discovery of a new, or the advancement of an existing, pressure ulcer or suspected deep tissue Injury.

Was any preventive intervention implemented? Question Location Event Tab – Additional Questions Section Description Determination if a prevention intervention was implemented, and if so, of the type of

prevention intervention(s). Prompt Check all that apply. Responses Pressure redistribution device

Repositioning Hydration and/or nutritional support Skin care practices to prevent moisture and shearing None Unknown Other (please describe)

Go-To Logic This question only appears if the event type is Pressure ulcer. If “other,” a text box for description will also open.

Required No Question Type Select Dropdown Guide for Use Answer this question only if an intervention to prevent the development or advancement of

pressure ulcers had been implemented for the patient.

Was the use of a device or appliance involved in the development or advancement of the pressure ulcer? Question Location Event Tab – Additional Questions Section Description Determination whether the device or appliance was involved in the development or

advancement of the pressure ulcer. Prompt n/a Responses Yes

No Unknown

Go-To Logic This question only appears if the event type is Pressure ulcer. If “yes”, opens the question “What was the type of device or appliance?”


What was the type of device or appliance? Question Location Event Tab – Additional Questions Section Description The device or appliance used that was associated with the pressure ulcer. Prompt Check all that apply Responses Anti-embolic device (e.g., compression stockings)

Intraoperative positioning device Orthopedic appliance (e.g., cast, splint, orthotic) Oxygen delivery device (e.g., nasal prongs, oxygen mask) Positioning device (e.g., lap buddy, wedge cushion)


Restraints Tube (includes endotracheal, gastrostomy, nasogastric, tracheostomy and indwelling urinary catheter) Other (please describe)

Go-To Logic This question only appears if “Was the use of a device or appliance involved in the development or advancement of the pressure ulcer?” was answered “yes.” If “other,” a text box for description will also open.

Required No Question Type Checkboxes Guide for Use Answer this question only if a device or appliance contributed to the development or

advancement of the pressure ulcer.


Surgical or Other Invasive Procedure Event

Type of surgical or other invasive procedure event Question Location Event Tab – Additional Questions Section Description Determination of the type of surgical or other invasive procedure event. Prompt Check all that apply. Select ‘Incorrect implant’ if a patient is given an incorrect implant (e.g.,

incorrect side, size, expired). In events where the implant was both incorrect and involved the use or function of the implant, please also select ‘Device or medical/surgical supply’ event from the ‘Event type’ list at the top of the page.

Incorrect patient Incorrect procedure (excluding procedures resulting from misidentification of the patient) Incorrect site or side Incorrect implant (e.g., incorrect size, incorrect side, expired) Dehiscence, flap or wound failure or disruption, or graft failure Iatrogenic pneumothorax Intraoperative or immediately postoperative/postprocedure death in an ASA Class 1 patient Laceration, perforation, puncture, or nick Postop bleeding requiring return to operating room Unintended blockage, obstruction, or ligation Unplanned removal of organ Other (please describe)

Go-To Logic This question only appears if the event type is Surgical or other invasive procedure event. If “other,” a text box for description will also open.

Required Yes, if event type is Surgical or other invasive procedure event. Question Type Checkboxes Guide for Use Please see Appendix IV for surgical or other invasive procedure event type definitions and

common inclusions and exclusions. You may also want to refer to the PSRP Corner articles related to this topic (https://oregonpatientsafety.org/blog/blog/what-is-the-difference-between-incorrect-patient-and-incorrect-procedure/734/; https://oregonpatientsafety.org/blog/blog/what-event-type-is-an-incorrect-implant/728/).

Number of staff changes (after timeout) Question Location Event Tab – Additional Questions Section Description Number of staff changes during the surgery or procedure, after the timeout. Prompt “Staff Changes” occur when any member of the surgical or procedural team is replaced by

another. Go-To Logic This question only appears if the event type is Surgical or other invasive procedure event or

an Unintended retained foreign object event. Required No Question Type Number Minimum Value 0 Maximum Value 99 Guide for Use “Staff Changes” occur when any member of the surgical or procedural team is replaced by

another. Indicate if any staff changes occurred during the procedure.

Was a safe surgery/procedure checklist used? Question Location Event Tab – Additional Questions Section Description Determination of whether or not a safe surgery or procedure checklist was used. Prompt n/a Responses Yes

No n/a

https://oregonpatientsafety.org/blog/blog/what-is-the-difference-between-incorrect-patient-and-incorrect-procedure/734/

https://oregonpatientsafety.org/blog/blog/what-is-the-difference-between-incorrect-patient-and-incorrect-procedure/734/

https://oregonpatientsafety.org/blog/blog/what-event-type-is-an-incorrect-implant/728/


Go-To Logic This question only appears if the event type is Surgical or other invasive procedure event or an Unintended retained foreign object event.

Required No Question Type Radio Buttons Guide for Use Using a safe surgery or procedure checklist should include all members of the surgical or

procedural team. Select “yes” if a safe surgery or procedure checklist was used even if the team was unable to complete it due to the adverse event.


Unintended Retained Foreign Object Event

Number of staff changes (after timeout) Question Location Event Tab – Additional Questions Section Description Number of staff changes during the surgery or procedure, after the timeout. Prompt “Staff Changes” occur when any member of the surgical or procedural team is replaced by

another. Go-To Logic This question only appears if the event type is an Unintended retained foreign object event or

a Surgical or other invasive procedure event. Required No Question Type Number Minimum Value 0 Maximum Value 99 Guide for Use “Staff Changes” occur when any member of the surgical or procedural team is replaced by

another. Indicate if any staff changes occurred during the procedure.

Was a safe surgery/procedure checklist used? Question Location Event Tab – Additional Questions Section Description Determination of whether or not a safe surgery or procedure checklist was used. Prompt n/a Responses Yes

No n/a

Go-To Logic This question only appears if the event type is an Unintended retained foreign object event or a Surgical or other invasive procedure event.

Required No Question Type Radio Buttons Guide for Use Using a safe surgery or procedure checklist should include all members of the surgical or

procedural team. Select “yes” if a safe surgery or procedure checklist was used even if the team was unable to complete it due to the adverse event.

Type of retained object Question Location Event Tab – Additional Questions Section Description Determination of the type of object retained. Prompt n/a Responses Sponge

Needle Guidewire Towel Whole instrument (e.g., clamp) (please describe) Instrument fragment (please describe) IV/IV part Other (please describe)

Go-To Logic This question only appears if the event type is Unintended retained foreign object. If “other,” a text box for description will also open.

Required Yes, if event type is Unintended retained foreign object. Question Type Select Dropdown Guide for Use Select the type of object that was unintentionally retained. If the type of object that was

unintentionally retained is not listed, select “Other” and specify the type. If more than one type of object was retained during the procedure, select “Other” and specify the types.


Were counts performed for the type of object that was retained? Question Location Event Tab – Additional Questions Section Description Determination if a count was performed for the type of object that was retained. Prompt Select “Yes” only if counts were performed (1) for a baseline and (2) completed immediately

before closure (or, if there was no wound, immediately before completion of the invasive procedure).

Responses Yes No, but object is “countable” No, and object is not “countable” Unknown

Go-To Logic This question only appears if the event type is Unintended retained foreign object. Required No Question Type Radio Buttons Guide for Use Select Yes only if counts were performed (1) for a baseline and (2) completed immediately

before closure (or, if there was no wound, immediately before completion of the invasive procedure). Select No, but object is ‘countable’ if the retained object is something your organization routinely counts. Select No, but object is not ‘countable’ if the retained object is not something your organization does not routinely count, or if it is an instrument fragment or part. Please note: the Oregon Patient Safety Commission recommends that all items that can potentially, unintentionally remain in a patient following a surgery or other invasive procedure should be counted, including guidewires.

Was the retained object identifiable by any of the following? Question Location Event Tab – Additional Questions Section Description Determination of whether the retained object was identifiable by one of the following:

radiopaque (i.e., detectable by x-ray), RFID (radio frequency identification, barcoded, or other.

Prompt Check all that apply. Responses Radiopaque

RFID (radio frequency identification) Barcode None of the above n/a

Go-To Logic This question only appears if the event type is Unintended retained foreign object. Required No Question Type Checkboxes Guide for Use Answer only for the specific object retained.

Metal objects are considered inherently radiopaque. An item found on a CT/x-ray is not inherently radiopaque.

Did the surgeon perform a cavity sweep? Question Location Event Tab – Additional Questions Section Description Determination of whether or not surgeon performed a cavity sweep. Prompt Check one. Responses Yes

No Unknown n/a

Go-To Logic This question only appears if the event type is Unintended retained foreign object. Required No


Question Type Radio Buttons Guide for Use Choose n/a only if the object was retained during the course of a non-surgical procedure.


Appendix I: List of facilities and multi-hospital systems

Multi-hospital system Hospital Facility

Adventist Health Adventist Medical Center Adventist Health Tillamook Regional Medical Center Asante Health System Asante Ashland Community Hospital Asante Health System Asante Rogue Regional Medical Center Asante Health System Asante Three Rivers Medical Center Capella Healthcare Willamette Valley Medical Center Catholic Health Initiatives Mercy Medical Center Catholic Health Initiatives St. Anthony Hospital Kaiser Permanente Kaiser Sunnyside Medical Center Kaiser Permanente Kaiser Westside Medical Center Lake Health District Lake District Hospital Legacy Health Legacy Emanuel Medical Center Legacy Health Legacy Good Samaritan Medical Center Legacy Health Legacy Meridian Park Medical Center Legacy Health Legacy Mount Hood Medical Center PeaceHealth PeaceHealth Cottage Grove Community Hospital PeaceHealth PeaceHealth Peace Harbor Hospital PeaceHealth PeaceHealth Sacred Heart Medical Center at Riverbend PeaceHealth PeaceHealth Sacred Heart Medical Center University District Providence Health & Services Providence Hood River Memorial Hospital Providence Health & Services Providence Medford Medical Center Providence Health & Services Providence Milwaukie Hospital Providence Health & Services Providence Newberg Medical Center Providence Health & Services Providence Portland Medical Center Providence Health & Services Providence Seaside Hospital Providence Health & Services Providence St. Vincent Medical Center Providence Health & Services Providence Willamette Falls Medical Center Saint Alphonsus Health System Saint Alphonsus Medical Center - Baker City Saint Alphonsus Health System Saint Alphonsus Medical Center - Ontario Salem Health Salem Health Salem Health West Valley Hospital Samaritan Health Services Samaritan Albany General Hospital Samaritan Health Services Good Samaritan Regional Medical Center Samaritan Health Services Samaritan Lebanon Community Hospital Samaritan Health Services Samaritan North Lincoln Hospital Samaritan Health Services Samaritan Pacific Communities Hospital St. Charles Health System St. Charles Bend St. Charles Health System St. Charles Madras St. Charles Health System St. Charles Prineville St. Charles Health System St. Charles Redmond Non-system Bay Area Hospital Non-system Blue Mountain Hospital Non-system Columbia Memorial Hospital Non-system Coquille Valley Hospital Non-system Curry General Hospital Non-system Good Shepherd Medical Center Non-system Grande Ronde Hospital Non-system Harney District Hospital


Non-system Lower Umpqua Hospital Non-system McKenzie-Willamette Medical Center Non-system Mid-Columbia Medical Center Non-system OHSU Hospital Non-system Pioneer Memorial Hospital & Nursing Facility Non-system Santiam Hospital Non-system Silverton Hospital Non-system Sky Lakes Medical Center Non-system Southern Coos Hospital & Health Center Non-system Tuality Community Hospital Non-system Wallowa Memorial Hospital

Appendix II: Harm Categories and Algorithm

Harm Categories

Category A Circumstances that have the capacity to cause an adverse event No adverse event

Category B An event occurred that did not reach the patient (an “error of omission”

does reach the patient)

Adverse event,

no harm

Category C An event occurred that reached the patient but did not cause patient harm

Category D An event occurred that reached the patient and required monitoring to

confirm that it resulted in no harm to the patient and/or required

intervention to preclude harm

Category E An event occurred that may have contributed to or resulted in temporary

harm to the patient but did not require a significant intervention

Adverse event,

harm

Category F An event occurred that may have contributed to or resulted in temporary

harm to the patient and required a significant intervention

Category G An event occurred that may have contributed to or resulted in permanent

patient harm

Category H An event occurred that required intervention necessary to sustain life

Category I An event occurred that may have contributed to or resulted in patient’s

death

Adverse event,

death

Adapted from “NCC MERP Index for Categorizing Medication Errors.”

2001 National Coordinating council for Medication Error Reporting and Prevention.

Definitions

Adverse Event An event resulting in unintended harm or creating the potential for harm that is related to any aspect of a patient’s care (by an act of commission or omission) rather than to the underlying disease or condition of the patient; adverse events may or may not be preventable

Harm Any physical injury or damage to the health of a person and/or pain resulting therefrom, including both temporary and permanent injury

Permanent Harm Harm lasting more than six months or where the end harm is not known

Monitoring To observe or record physiological or psychological signs

Intervention May include change in therapy or active medical/surgical treatment

Intervention Necessary to Sustain Life Includes cardiovascular and/or respiratory support (e.g., CPR, defibrillation, intubation)

Significant Intervention An intervention intended to relieve symptoms that have the potential to be life-threatening if not addressed.


Was intervention to

preclude harm/extra

monitoring

required?

Was intervention

necessary to

sustain

life required?

Was the harm

permanent?

Category H

Yes

Yes

Yes

No

Yes

No

Category C

No

Category D

Yes

Category I Yes

No

Was the harm

temporary?

Yes

Yes

Category E No

Category G

No

No

Yes

Category F

Adapted from “NCC MERP Index for Categorizing Medication Errors Algorithm.”

2001 National Coordinating council for Medication Error Reporting and

Prevention.

Harm Algorithm

Adverse Event An event resulting in unintended harm or creating the potential for harm that is related to any aspect of a patient’s care (by an act of commission or omission) rather than to the underlying disease or condition of the patient; adverse events may or may not be preventable

Harm Any physical injury or damage to the health of a person and/or pain resulting therefrom, including both temporary and permanent injury

Monitoring To observe or record physiological or psychological signs

Intervention May include change in therapy or active medical/surgical treatment

Intervention Necessary to Sustain Life Includes cardiovascular and/or respiratory support (e.g., CPR, defibrillation, intubation)

Significant Intervention An intervention intended to relieve symptoms that have the potential to be life-threatening if not addressed.

* An error of omission does reach the patient ** See Data Dictionary for examples of significant interventions

Circumstances that have the

capacity to cause an adverse event

Did an actual

adverse event

occur?

Did the

event reach the

patient? *

Did the event

contribute to or

result in patient

death?

Was the patient

harmed?

Permanent Harm is harm lasting

more than six months or where

the end harm is not known

Category B No

Category A

No

Did the event

require a significant

intervention? **

Appendix III: Event Type Descriptions A brief definition for each event type is provided below. If pertinent, common inclusions (“INCLUDES”), common

exclusions (‘EXCLUDES”), and a note about specific instances that should be submitted as two different event types

(“NOTE”) are also provided. The lists of inclusions and exclusions are not exhaustive; if you have additional

questions, please contact your Patient Safety Consultant.

Event type Definition

Air embolism Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare facility.

INCLUDES: 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

EXCLUDES: deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism

Anesthesia Patient death or serious injury associated with anesthesia.

INCLUDES: incorrect anesthetic gas; adverse reaction to anesthesia; under- or oversedation; malignant hyperthermia, incorrect site anesthesia

EXCLUDES: contaminated anesthetic gas (submit as “contaminated, wrong or no gas given to patient”); anesthetic medication (submit as “medication or other substance”); problem with device used in the delivery of anesthesia (submit as “device or medical/surgical supply”)

Aspiration Patient death or serious injury associated with an aspiration.

INCLUDES: aspiration pneumonia (submit as both “aspiration” and “healthcare-associated infection” events)

Blood or blood product (including hemolytic reactions)

Patient death or serious injury associated with unsafe administration of blood products.

INCLUDES: hemolytic reaction; mislabeled blood; incorrect type; incorrect blood product; expired blood product

Burn (unrelated to the use or misuse of a device or medical/surgical supply)

Patient death or serious physical injury associated with a burn incurred from any source other than the use or misuse of a device or medical/surgical supply while being cared for in a healthcare facility.

INCLUDES: burn caused by something other than a piece of equipment or medical/surgical supply (e.g. hot water, sunburn, smoking in patient care environment)

EXCLUDES: burn caused by a piece of equipment or medical/surgical supply (submit as “device or medical/surgical supply (including use error)”)

Care delay (including delay in treatment, diagnosis)

Patient death or serious injury related to a delay in care, diagnosis, or treatment.

INCLUDES: delay in treatment or intervention; delay in diagnosis; delay in recognizing changing condition; failure to rescue

EXCLUDES: delay in notifying patient or provider of lab or radiology reports (submit as “failure to follow up or communicate laboratory, pathology, or radiology test results”)

Contaminated drugs, devices, or biologics

Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting.

INCLUDES: contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product; threat of disease that changes patient’s risk status for life requiring medical monitoring not needed before the event; 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 (e.g. unwashed medical equipment, unsterile instrument tray)

EXCLUDES: contaminated gas (submit as “contaminated, wrong or no gas given to a patient”)

Contaminated, wrong or no gas given to a patient

Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the incorrect gas, or is contaminated by toxic substances.

INCLUDES: anesthetic or medical gases

Device or medical/ surgical supply (including use error)

Patient death or serious injury associated with the use or function of a device or medical/surgical supply in patient care, in which the device is used or functions other than as intended.

INCLUDES: use error; scans read on incorrect monitor; non-functional/unavailable scanning equipment; patient misuse of equipment at home; latex gloves used for a procedure on a latex allergic patient; problem with device used in the delivery of anesthesia

EXCLUDES: incorrect implant (submit as “surgical or other invasive procedure” event); incorrect graft tissue (submit as “surgical or other invasive procedure” event); unavailable equipment during a surgical procedure (submit as “surgical or other invasive procedure” event); using expired bone matrix admixture in a procedure (submit as “expired medication or substance”)

Discharge or release of a patient of any age, who is unable to make decisions, to an unauthorized person

Discharge or release of a patient of any age, who is unable to make decisions, to an unauthorized person.

INCLUDES: newborns; minors; adults with cognitive impairments (e.g., Alzheimer’s and dementia)

EXCLUDES: events involving competent adults with decision-making capacity who leave against medical advice or voluntarily leave without being seen

Electric shock Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting.

INCLUDES: patient death or injury associated with unintended electric shock during the course of care or treatment

EXCLUDES: events involving patients during planned treatments such as electric countershock/elective cardioversion; 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

Elopement Patient death or serious injury associated with patient elopement (disappearance).

INCLUDES: events that occur after the individual presents him/herself for care in a healthcare setting

EXCLUDES: events involving competent adults with decision-making capacity who leave against medical advice or voluntarily leave without being seen; death or serious injury that occurs (after the patient is located) due to circumstances unrelated to the elopement

Failure to follow up or communicate laboratory, pathology, or radiology test results

Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.

INCLUDES: delay in notifying patient or provider of lab or radiology reports; misreporting critical test results; failure to identify and treat hyperbilirubinemia in neonate (hyperbilirubinemia is defined as bilirubin levels >30 mg/dl in neonates);



mislabeled pathology; lab error resulting in transfer of patient to another facility; omitted tests; incorrect results

EXCLUDES: biological specimens that cannot be replaced associated with mislabeled pathology, lab error resulting in transfer of patient to another facility, omitted tests, incorrect results (submit as “irretrievable loss of an irreplaceable biologic specimen”)

Fall Patient death or serious injury associated with a fall while being cared for in a healthcare setting. “Fall” refers to unintentionally coming to rest on the ground, floor, or other lower level, but not as a result of an overwhelming external force (e.g., resident pushes another resident). An episode where a resident lost his/her balance and would have fallen, if not for staff intervention, is considered a fall. A fall without injury is still a fall. Unless there is evidence suggesting otherwise, when a resident is found on the floor, a fall is considered to have occurred.

INCLUDES: falls resulting in fractures, head injuries, intracranial hemorrhage; newborn or infant drops; patient falls or drops from equipment (e.g., bed, lift)

EXCLUDES: falls associated with suicide or attempted suicide

Note: you may want to refer to the PSRP Corner article on this topic (https://oregonpatientsafety.org/blog/blog/how-should-i-define-a-fall/687/)

Healthcare-Associated Infection (HAI)

Patient death or serious injury associated with an infection acquired while being cared for in a healthcare setting.

INCLUDES: infections acquired in the acute care setting that result in readmission, increased length of stay, or cause/contribute to patient death, (e.g. primary blood stream infections, central line associated blood stream infections (CLABSI), pneumonia, ventilator-associated pneumonia (VAP), sepsis, surgical site infection (SSI), urinary tract infection (UTI), catheter-associated urinary tract infection (CAUTI))

EXCLUDES: infections present or incubating on admission treated and eliminated prior to discharge; infection resulting from contaminated device, drug or biologic (submit as “contaminated device, drug or biologic”)

Irretrievable loss of an irreplaceable biologic specimen

Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen.

INCLUDES: biological specimens that cannot be replaced associated with mislabeled pathology, lab error resulting in transfer of patient to another facility, omitted tests, or incorrect results

EXCLUDES: miscommunicated or lost laboratory, pathology, or radiology test results (submit as “failure to follow up or communicate laboratory, pathology, or radiology test results”); biological specimens that can be replaced associated with mislabeled pathology, lab error resulting in transfer of patient to another facility, omitted tests, or incorrect results (submit as “failure to follow up or communicate laboratory, pathology, or radiology test results”); mislabeled blood (submit as “blood or blood product”); lost specimen that is not noticed until later (submit as “other”)

Maternal Death or serious injury of a woman associated with labor or delivery while being cared for in a healthcare facility.

INCLUDES: maternal death; third or fourth degree perineal lacerations or tears; uterine rupture

EXCLUDES: deaths from pulmonary or amniotic fluid embolism; acute fatty liver of pregnancy; cardiomyopathy

Medication or other substance

Patient death or serious injury associated with a medication or other substance.

INCLUDES: hypoglycemia; incorrect medication or substance; incorrect dose; incorrect

https://oregonpatientsafety.org/blog/blog/how-should-i-define-a-fall/687/



patient; incorrect time; incorrect rate; incorrect preparation; incorrect route of administration, incorrect dosage form; incorrect strength; expired medication or substance; incorrect or incomplete labeling; contraindication; omission/discontinuation; adverse reaction, allergic reaction; drug interaction; anesthetic medication; contrast media or other diagnostic substances

EXCLUDES: reasonable differences in clinical judgment on drug selection and dose; adverse reaction to anesthesia (submit as “anesthesia”); blood product (submit as “blood or blood product”)

Perinatal Death or serious injury of a fetus or neonate during the perinatal period associated with labor or delivery while being cared for in a healthcare facility.

INCLUDES: stillbirth; shoulder dystocia; encephalopathy; neonatal resuscitation; newborn death; fetal demise

EXCLUDES: events that occur outside of the perinatal period (which extends from the 20th week of gestation through 4 weeks (28 days) postpartum)

Pressure ulcer (also means pressure injury)

Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare setting.

INCLUDES: Stage 3 or 4 pressure ulcers, or pressure ulcers present on admission that progressed during the patient’s stay (see exception below); suspected deep tissue injuries; unstageable pressure ulcers; those that were not present on admission and occurred prior to patient discharge (i.e., newly-developed)

EXCLUDES: progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission; pressure ulcers that develop in areas where deep tissue injury is documented as present on admission/presentation

Radiologic Patient death or serious injury associated with radiologic treatment.

INCLUDES: the NQF Serious Reportable Event “death or serious injury of a patient associated with the introduction of a metallic object into the MRI area;” MRI too small for patient on which it was used; patient overdosed by poorly calibrated CT or similar; delivery of fluoroscopy or radiotherapy to the incorrect region of the body

EXCLUDES: scans read on incorrect monitor (submit as “device or medical/surgical supply”); non-functional/unavailable scanning equipment (submit as “device or medical/surgical supply”)

Restraint or bed rail related

Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a healthcare facility.

INCLUDES: strangulation; entrapment

EXCLUDES: suicide (submit as “suicide or attempted suicide”)

Suicide or attempted suicide

Patient suicide or attempted suicide resulting in serious physical injury, while being cared for in a healthcare facility.

INCLUDES: events that result from patient actions after admission to a healthcare facility

EXCLUDES: deaths resulting from self-inflicted injuries that were the reason for admission/presentation to the healthcare facility

Surgical or other invasive procedure

Patient death or serious injury associated with a surgery or invasive procedure and any injury resulting from an incorrect patient, incorrect site surgery or invasive procedure, or incorrect procedure event.

INCLUDES: endoscopies; lens implants; lesion removal; injection into joints; dehiscence, flap or wound failure or disruption, or graft failure; iatrogenic pneumothorax; laceration; perforation; puncture; nick; incorrect implant; postop



bleeding requiring return to operating room; unintended blockage, obstruction, or ligation; unplanned removal of an organ; incorrect graft tissue

Unintended retained foreign object

Unintended retention of a foreign object in a patient after surgery or other invasive procedure.

INCLUDES: medical or surgical items intentionally placed by provider(s) that are unintentionally left in place; objects not present prior to surgery/procedure that are intentionally left in when the risk of removal exceeds the risk of retention (such as some needles, broken screws); retained surgical item (RSI)

EXCLUDES: objects intentionally implanted as part of a planned intervention and objects present prior to surgery that were intentionally retained; objects present prior to surgery or other invasive procedure that are intentionally left in place; objects intentionally implanted as part of a planned intervention

Other Patient death or serious injury related to an event not otherwise included in the above categories.

INCLUDES: any unanticipated, usually preventable event that results in serious physical injury, even if the harm is temporary; only events that are not related to the natural course of the patient’s illness or underlying condition; injuries not related to another event; thromboembolism; events related to poor discharge planning or inadequate patient assessment; premature pronouncement of death; transfer/transport related events; events related to spinal manipulative therapy

EXCLUDES: events related to the natural course of the patient’s illness or underlying condition; injuries related to another event


Appendix IV: Anesthesia Event Type Descriptions


Awareness (during anesthesia)

Patient death or serious injury associated with awareness during anesthesia.

INCLUDES: under-sedation

EXCLUDES: surgeries or other invasive procedures in which the patient is intentionally conscious

Malignant hyperthermia Patient death or serious injury associated with malignant hyperthermia.

INCLUDES: malignant hyperthermia that requires treatment with a rescue drug

Oversedation Patient death or serious injury associated with oversedation.

INCLUDES: oversedation associated with anesthesia during the operative period and prior to discharge from the PACU

EXCLUDES: oversedation associated with medications after the patient has left the PACU (submit as “medication or other substance”)

Physical injury Serious physical injury associated with anesthesia.

INCLUDES: dental injury; ocular injury; peripheral nerve injury

Incorrect site anesthesia Patient death or serious injury associated with an anesthetic block placed at an incorrect site.

INCLUDES: regional blocks

Difficulty managing airway

Patient death or serious injury associated with difficulty managing the patient’s airway related to anesthesia.

INCLUDES: difficulty during tracheal intubation; difficulty maintaining airway during procedure; esophageal intubation; re-intubation, following unplanned/unintended extubation, in the operating or recovery room

Other Patient death or serious injury related to an anesthesia event not otherwise included in the above categories.

INCLUDES: inadvertent bilateral epidural phrenic nerve block; adverse reaction to anesthesia

EXCLUDES: contaminated anesthetic gas (submit as “contaminated, wrong, or no gas given to the patient”); anesthetic medication (submit as “medication or other substance”); problem with device used in the delivery of anesthesia (submit as “device or medical/surgical supply”)


Appendix V: Healthcare-Associated Infection Event Type Descriptions


Eye, ear, nose, throat, or mouth infection

Patient/resident death or serious injury related to a healthcare-associated eye, ear, nose, throat, or mouth infection

Gastrointestinal system infection

Patient/resident death or serious injury related to a healthcare-associated gastrointestinal system infection

INCLUDES: C. diff infections (select “C. difficile” as the Pathogen)

Lower respiratory tract infection (other than pneumonia)

Patient/resident death or serious injury related to a healthcare-associated lower respiratory tract infection (other than pneumonia)

EXCLUDES: pneumonias (submit as Pneumonia)

Primary blood stream infection (BSI)

Patient death or serious injury related to a healthcare-associated primary blood stream infection.

Central line associated BSI (CLABSI)

Patient death or serious injury related to a healthcare-associated central line associated primary blood stream infection.

A catheter-associated bloodstream infection (CLABSI) is a primary bloodstream infection (BSI) in a patient that had a central line within the 48-hour period before the development of the BSI and that is not related to an infection at another site. NOTE: There is no minimum period of time that the central line must be in place in order for the BSI to be considered central line-associated.

Pneumonia Patient death or serious injury related to healthcare-associated pneumonia.

INCLUDES: aspiration pneumonia (submit as both “aspiration” and “healthcare-associated infection” events)

Ventilator-associated Pneumonia (VAP)

Patient death or serious injury related to healthcare-associated ventilator-associated pneumonia.

A ventilator-associated pneumonia (VAP) is pneumonia that occurs in a patient who was intubated and ventilated at the time of, or within 48 hours before, the onset of the pneumonia.

EXCLUDES: patients with a diagnosis of pneumonia on admission

Sepsis Patient death or serious injury related to healthcare-associated sepsis.

Surgical site infection (SSI)

Patient death or serious injury related to healthcare-associated surgical site infection.

INCLUDES: all invasive procedures

Urinary tract infection (UTI)

Patient death or serious injury related to healthcare-associated urinary tract infection.

Catheter-associated UTI (CAUTI)

Patient death or serious injury related to healthcare-associated catheter-associated urinary tract infection.

A catheter-associated urinary tract infection (CAUTI) is a urinary tract infection (UTI) that occurs in a patient who had an indwelling urinary catheter in place within the 48-hour period before the onset of the UTI.

Other Patient death or serious injury related to a healthcare-associated infection not otherwise included in the above categories.

INCLUDES: facial cellulitis


Appendix VI: Medication or Other Substance Event Type Descriptions


Incorrect medication or substance

Patient death or serious injury associated with being given a medication or other substance that was not ordered for him or her, or was intended for another patient.

INCLUDES: medications intended for another patient; medication or other substance that was not ordered for patient

EXCLUDES: incorrect graft tissue (submit as a “surgical or other invasive procedure” event); medication not appropriate to the patient’s clinical situation (e.g., giving a patient with a drug resistant infection a drug in the family to which the infection is resistant) (submit as “medication or other substance contraindicated”)

Incorrect route Patient death or serious injury associated with being given a medication or other substance through the incorrect route of administration.

INCLUDES: injection of medication or substance given instead of medication or substance being used for irrigation; giving IM dose titrated through IV; suspension medication given through PICC instead of PEG; giving a suppository instead of tablet; giving a patch instead of an IV

Incorrect dosage form Patient death or serious injury associated with being given a medication or other substance in the incorrect dosage form.

INCLUDES: sustained release instead of immediate release; giving tablet instead of liquid form

Incorrect strength Patient death or serious injury associated with being given a medication or other substance in the incorrect strength/concentration.

INCLUDES: concentrations that are too high or too low; patient is given an “unmixed” antibiotic that was supposed to mixed with another substance; patches applied that

are the incorrect concentration (e.g., Fentynl patch 25gm instead of 50gm)

Incorrect dose Patient death or serious injury associated with being given a medication or other substance in the incorrect dose (i.e., too much or too little).

INCLUDES: giving too much or too little of a medication or other substance at once; overdose; underdose; extra dose

EXCLUDES: omitted medication (submit as “medication or substance omitted”); incorrectly discontinued medication (submit as “medication or substance discontinued”); IV medications given at an incorrect rate (submit as “incorrect rate”)

Incorrect rate Patient death or serious injury associated with being given a medication or other substance at the incorrect rate.

INCLUDES: giving too much or too little of an IV medication or other substance over time

Incorrect time Patient death or serious injury associated with being given a medication or other substance at the incorrect time (i.e., too early or too late).

INCLUDES: patient was given ordered medication too early or too late; giving ordered medications 30 minutes before or after dose is indicated by prescription in a hospital; ordering a medication late resulting in late administration

Expired medication or substance

Patient death or serious injury associated with being given a medication or other substance whose expiration date has passed.

INCLUDES: giving medications or other substances whose expiration date has passed; using expired bone matrix admixture in a procedure



Incorrect/incomplete labeling

Patient death or serious injury associated with being given a medication or other substance with incorrect or incomplete labeling.

INCLUDES: medication hung and infused but not labeled or documented

EXCLUDES: mislabeled blood products (submit as “blood or blood product”)

Medication or substance contraindicated (includes documented allergies and sensitivities)

Patient death or serious injury associated with being given a medication or other substance they should not have been given for a known, documented reason.

INCLUDES: patient given a medication or other substance, or a prescription for a medication or other substance, they should not have been given for a documented reason regardless of result; drug-drug contraindication; drug-food contraindication; drug-disease contraindication; drug-clinical condition contraindication

Medication or substance discontinued

Patient death or serious injury associated with the incorrect discontinuation of a medication or other substance without an order.

INCLUDES: ordered medication or substance discontinued without order; O2 discontinued without order

Medication or substance omitted

Patient death or serious injury associated with not being given a medication or other substance that they should have received.

INCLUDES: prescribed medication not given for any reason, including incomplete medication reconciliation at intake or discharge and failure to process/enter medication reconciliation form; giving air instead of injectable medication or substance; giving epidural medication through a disconnected line; ordering a medication late that is not administered to the patient

EXCLUDES: medications that have been incorrectly discontinued (submit as “medication or substance discontinued”)

Adverse reaction not due to allergy or known contraindication

Patient death or serious injury associated with being given a medication or other substance (at normal dosage during normal use) for which an adverse reaction occurred that was not due to an allergy or known contraindication.

INCLUDES: anticholinergic reaction syndrome as a result of medication administration; severe hypotensive event as a result of medication administration; other reactions that cannot be classified as an allergic reaction

EXCLUDES: unanticipated allergic reactions (submit as “allergic reaction”) or documented allergies or sensitivities (submit as “medication or other substance contraindicated”)

Allergic reaction due to unknown allergy

Patient death or serious injury associated with being given a medication or other substance for which an unanticipated allergic reaction occurred either in the facility or at home and reported to facility post-discharge.

INCLUDES: an inappropriate immune response, such as a rash or hives, as a result of medication administration; anaphylaxis as a result of medication administration

EXCLUDES: allergic reactions due to documented allergies (choose “medication or substance contraindicated”)

Drug interaction Patient death or serious injury associated with an unanticipated drug interaction.

INCLUDES: ordered medications in hospital interacting with recreational drugs

EXCLUDES: drug interactions due to contraindications



Oversedation Patient death or serious injury associated with one or more medications that result in a level of sedation greater than the desired therapeutic level of sedation.

INCLUDES: oversedation associated with medications after the patient has left the PACU

EXCLUDES: oversedation associated with anesthesia during the operative period and prior to discharge from the PACU (submit as “anesthesia”)

Other Patient death or serious injury associated with being given a medication or other substance not otherwise included in the above categories.

INCLUDES: placing epidural needle in subarachnoid space instead of epidural space; patient non-compliant with medication discontinuation instructions prior to surgery; incorrect prescription sent home with patient; transcription error on discharge medication schedule; incorrect preparation, including inappropriate cutting of tablets, error in compounding, mixing, etc.; incorrect patient/family action (e.g. self-administration error)


Appendix VII: Surgical or Other Invasive Procedure Event Type Descriptions


Incorrect patient Any surgical or other invasive procedure on a patient identified as a different patient.

INCLUDES: surgical procedure (whether or not completed) initiated on one patient identified as a different patient; taking a patient into a surgical suite intended for another patient’s procedure

Incorrect procedure (excluding procedures resulting from misidentification of the patient)

Any surgical or other invasive procedure performed on a patient that that is not consistent with the documented informed consent for that patient.

INCLUDES: performing a procedure not intended for the patient (whether or not it was intended for another patient); patient consented to incorrect surgery/invasive procedure; performing an incorrect procedure on the correct site (e.g. trigger finger surgery instead of carpal tunnel)

EXCLUDES: incorrect procedures resulting from misidentification of the patient (submit as “incorrect patient”); excludes emergent situations that occur in the course of surgery and/or whose urgency precludes obtaining informed consent

Incorrect site or side Any surgical or other invasive procedure performed on a site/side of a patient that that is not consistent with the documented informed consent for that patient.

INCLUDES: surgery or other invasive procedure on the right body part but on the incorrect location/site on the body (e.g., left/right (appendages/organs), incorrect digit, level (spine), stent placed in incorrect iliac artery, steroid injection into incorrect knee, biopsy of incorrect mole, burr hole on incorrect side of skull); 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)

EXCLUDES: emergent situations that occur in the course of surgery and/or whose urgency precludes obtaining informed consent; regional or other local anesthesia (submit as “anesthesia”); incorrect site or side implant (submit as “incorrect implant”)

NOTE: although an incorrectly placed surgical mark could result in surgery being performed on the incorrect body part, surgery does not begin at time the surgical mark is made on the patient. Placing a mark on the incorrect body part or site does not in itself constitute incorrect site surgery

Incorrect implant Patient death or serious injury associated with the use of an implant other than the intended implant during a surgical or other invasive procedure.

INCLUDES: incorrect side implant (right knee instead of left, or vice versa); incorrect size implant (small instead of medium, etc.); expired implant; incorrect graft tissue

EXCLUDES: incorrect size surgical equipment (e.g. tibial spacer) (submit as “device or medical/surgical supply”); broken implant (submit as “device or medical/surgical supply”)

Dehiscence, flap or wound failure or disruption, or graft failure

Patient death or serious injury associated with a surgical or other invasive procedure that resulted in dehiscence, flap or wound failure or disruption, or graft failure.

INCLUDES: dehiscence following Cesarean section or bariatric surgery; failure of dialysis fistula

EXCLUDES: wound dehiscence associated with infection (submit as “healthcare associated infection,” specifically as a “surgical site infection (SSI)”)



Iatrogenic pneumothorax Patient death or serious injury associated with a surgical or other invasive procedure that resulted in an iatrogenic pneumothorax.

INCLUDES: a pneumothorax resulting from mechanical ventilation, tracheostomy tube placement, or other therapeutic intervention

Intraoperative or immediately postoperative/ postprocedure death in an ASA Class 1 patient

Intraoperative or immediately postoperative/procedure death in an *ASA Class I patient associated with the surgical or other invasive procedure.

*American Society of Anesthesiologists (ASA) Class I means a preoperative healthy patient, no medical problems

INCLUDES: all ASA Class I 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 induction of anesthesia (if surgery not completed), surgery, or other invasive procedure was completed

Laceration, perforation, puncture, or nick

Patient death or serious injury associated with an unintended laceration, perforation, puncture, or nick during a surgical or other invasive procedure.

INCLUDES: abnormal opening in a hollow organ or viscus; placing a central line through the intrajugular into the carotid; an accidental cut wound; a hole made with a pointed object/instrument

Postop bleeding (requiring return to operating room)

Patient death or serious injury associated with a surgical or other invasive procedure that resulted in any unanticipated post-operative bleeding and requires a return to the operating room.

INCLUDES: immediate postop bleeding requiring return to surgery; postop bleeding discovered at home requiring return to surgery; postop bleeding requiring admission to hospital; postop bleeding requiring an unplanned visit to the emergency department

Unintended blockage, obstruction, or ligation

Patient death or serious injury associated with a surgical or other invasive procedure that resulted in an unintended blockage, obstruction, or ligation.

INCLUDES: post procedure ileus

Unplanned removal of organ

Patient death or serious injury associated with a surgical or other invasive procedure that resulted in the unplanned removal of an organ.

INCLUDES: organs removed as a result of operative injury

EXCLUDES: the incorrect organ being removed (e.g., performing a splenectomy instead of a nephrectomy) (submit as “incorrect procedure”); removal of right instead of left kidney (submit as “incorrect site or side”)

Other Patient death or serious injury associated with a surgical or other invasive procedure not otherwise included in the above categories.


Appendix VIII: Contributing Factor Descriptions

Communication Communication factors may be related to any spoken or written communication between anyone in a

facility, including, but not limited to, providers, staff, patients, and patient families. Ineffective

communication is communication that was inaccurate, incomplete, ambiguous, misunderstood by the

recipient, or not timely.

Factor Definition

Across units Ineffective communication between representatives of different units or departments in a facility contributed to the event.

INCLUDES: one or more units within a facility; misinterpreted communication; incomplete, not timely, inaccurate communication

EXCLUDES: communication among healthcare professionals working within a designated team or service (select “Among interdisciplinary teams"); communication related to handoffs, handovers or shift reports (select “Handoffs, handovers or shift reports”); communication between units at different facilities in the same healthcare system (select “With other organizations or outside providers”)

Among interdisciplinary teams Ineffective communication among any group of healthcare professionals from diverse fields who work to coordinate the care of a patient in a facility contributed to the event.

INCLUDES: healthcare professionals in different disciplines working within a designated team or service (e.g., Rapid Response, Code Blue, Infection Prevention)

EXCLUDES: communication related to handoffs, handovers or shift reports (select “Handoffs, handovers or shift reports”); communication between unit staff and supervisor or manager (select “Between supervisor and staff”)

Between providers and staff Ineffective communication between provider and staff in a facility contributed to the event.

INCLUDES: staff does not communicate with provider; provider does not communicate with staff; misinterpreted communication; incomplete, not timely, inaccurate communication

EXCLUDES: communication related to handoffs, handovers or shift reports (select “Handoffs, handovers or shift reports”); communication between unit staff and supervisor or manager (select “Between supervisor and staff”); communication among healthcare professionals working within a designated team or service (select “Among interdisciplinary teams”)

Between supervisor and staff Ineffective communication between supervisor and staff in a facility contributed to the event.

INCLUDES: misinterpreted communication; incomplete, not timely, inaccurate communication

EXCLUDES: communication related to handoffs, handovers or shift reports (select “Handoffs, handovers or shift reports”); communication among healthcare professionals working within a designated team or service (select “Among interdisciplinary teams”)


Factor Definition

Handoffs, handovers or shift reports Ineffective communication related to handoffs, handovers or shift reports in a facility or between facilities contributed to the event.

INCLUDES: all healthcare professionals; misinterpreted communication; incomplete, not timely, inaccurate communication; transfers of patients from one facility to another (also select “With other organizations or outside providers”)

EXCLUDES: communication between unit staff and supervisor or manager (select “Between supervisor and staff”); communication among healthcare professionals working within a designated team or service (select “Among interdisciplinary teams”)

Hard to read fax or handwriting Hard to read handwriting or a hard to read fax contributed to the event.

INCLUDES: illegible printing or handwriting; printing too light to read clearly; a healthcare professional’s temporary notes to self

Within units Ineffective communication within a unit in a facility contributed to the event.

EXCLUDES: across staff on multiple units (select “Across units”); communication related to handoffs, handovers or shift reports (select “Handoffs, handovers or shift reports”); communication between unit staff and supervisor or manager (select “Between supervisor and staff”); communication among healthcare professionals working within a designated team or service (select “Among interdisciplinary teams”)

With other organizations or outside providers

Ineffective communication with other organizations or outside providers contributed to the event.

INCLUDES: different facility or location within the same healthcare system

Other (please describe) Any other factor related to communication among facility personnel, not included in the list above, which contributed to the event.

INCLUDES: inadequate available information that is not covered by one of the existing factors

Culture Ineffective communication related to cultural differences between facility personnel and the patient or patient’s family contributed to the event.

INCLUDES: failure to recognize cultural prohibitions and preferences

EXCLUDES: language barriers (select “Language”)

Language A component of language that impacted the communication between patients and facility personnel contributed to the event.

INCLUDES: spoken language; American Sign Language (ASL); pronunciation or accent; lack of or inappropriate translation services

Miscommunication Miscommunication between facility personnel and the patient or patient’s family contributed to the event.

INCLUDES: incorrect information regarding condition, medications, etc., provided to or by patient or patient’s family

EXCLUDES: misunderstood or incorrect discharge instructions (select “Understanding discharge instructions or plan”)


Factor Definition

Patient did not use call light Patient does not use call light to communicate needs with staff.

INCLUDES: any reason a patient does not use a call light (e.g., patient cannot remember to use call light, patient desire for privacy or independence, patient does not want to bother staff)

EXCLUDES: call light not available (select “Device , equipment, or supply availability”); call light not working (select “Device, equipment, or supply Function (e.g., defective, non-working)”); call light alarms turned off (select “Device, equipment, or supply Use or selection by healthcare provider or staff” or “Device, equipment, or supply Use by patient”); patient not provided instruction for using call light (select “Miscommunication”)

Patient unable to communicate Patient’s physical inability to communicate contributed to the event.

INCLUDES: nonverbal patient; patient unable to communicate due to clinical condition (e.g., ventilated, comatose)

EXCLUDES: patient provides incorrect information or fails to disclose information to care team (select “Miscommunication”); patient is difficult to understand (select “Miscommunication”); patient has language barrier (select “Language”)

Understanding discharge instructions or plan

Ineffective communication impacting the patient’s understanding of discharge instructions or discharge plan contributed to the event.

INCLUDES: missing, incomplete, or inaccurate information about medications, next appointment, limitations, indications for provider evaluation of symptoms after discharge from facility; ineffective communication of discharge instructions (either written or verbal); lack of confirmation of patient understanding

Other (please describe) Any other factor related to communication between facility staff or providers and the patient or patient's family not included in the list above, which contributed to the event.


Device, equipment, or supply Factor Definition

Availability The availability, or lack thereof, of a device, equipment, or supply contributed to the event.

INCLUDES: device, equipment or supply not adequately stocked; device, equipment or supply not available when needed; device, equipment or supply not accessible when needed; device, equipment or supply correct size not available; device, equipment or supply available when it should not have been

EXCLUDES: shortages (select “Shortage”)

Design The design of a device, equipment, or supply, regardless of how it functions, contributed to the event.

INCLUDES: device or equipment display or controls not well-designed, difficult to read, or difficult to program; device, equipment or supply awkward to use correctly; device, equipment, or supply did not have built in safety features

EXCLUDES: device, equipment, or supply was not designed for the task for which it was being used (select “Use or selection by a healthcare provider or staff”)

Function (e.g., defective, non-working)

The function of a device, equipment, or supply, regardless of how it is designed, contributed to the event.

INCLUDES: defective or non-working device, equipment, or supply (including defective or dysfunctional alerts); device display or controls not functioning; broken or defective device, equipment, or supply that was awaiting repair contributed to the event

EXCLUDES: device, equipment, or supply that functioned as intended, but whose design contributed to the event (select “Design”)

Maintenance Routine maintenance, or lack thereof, of a device, equipment, or supply contributed to the event.

INCLUDES: device, equipment, or supply did not meet code, specifications, or regulations; inadequate maintenance log; inadequate or delayed maintenance; inadequate cleaning or sterilization

EXCLUDES: broken or defective device, equipment, or supply that was awaiting repair contributed to the event (select “Function”)

Shortage Manufacturer shortage of a device, equipment, or supply contributed to the event.

INCLUDES: device, equipment, or supply not readily available due to a manufacturer shortage; medication supply shortages

EXCLUDES: failure to properly stock supplies (select “Availability”)


Factor Definition

Use or selection by healthcare provider or staff

The incorrect use or inappropriate selection of a device, equipment, or supply by a healthcare provider or staff member contributed to the event.

INCLUDES: provider or staff member did not use the device, equipment, or supply correctly; provider or staff member did not select the correct device, equipment, or supply for the task at hand

EXCLUDES: device, equipment, or supply did not function properly (select “Function”); design of the device, equipment, or supply prohibited the provider or staff from using the device correctly (select “Design”); device, equipment, or supply was used incorrectly by a patient (select “Use by patient”); wrong device, equipment, or supply was selected for use by a patient (select “Use by patient”)

Use by patient The selection of a device, equipment, or supply for use by a patient was incorrect or the patient used the device incorrectly.

INCLUDES: device, equipment, or supply was used incorrectly by a patient; wrong device, equipment, or supply was selected for use by a patient

EXCLUDES: device or equipment did not function properly (select “Function”); design of the device, equipment, or supply prohibited the provider or staff from using the device correctly (select “Design”); provider or staff member did not use the device, equipment, or supply correctly (select “Use or selection by healthcare provider or staff”); provider or staff member did not select the correct device, equipment, or supply for the task (select “Use or selection by healthcare provider or staff”)

Other (please describe) Any other factor related to the device, equipment, or supply, not included in the list above, contributed to the event.

INCLUDES: recalls


Human or environmental Human or environmental factors may be internal to individual staff members (e.g., fatigue, health

issues) or related to the physical environment (e.g., clutter, lighting).

Factor Definition

Alarm fatigue

Desensitization to alarms resulting from alarms sounding in the absence of real healthcare problems, contributed to the event.

INCLUDES: alarm fatigue related to alarms on equipment, computers, barcode devices, telemetry monitors, call lights

EXCLUDES: health information technology (HIT) alerts and notifications such as those in the electronic health record or pharmacy systems (see "HIT" questions on Event Tab)

Clutter

Clutter in the environment contributed to the event.

INCLUDES: unnecessary or unorganized paper, supplies, documents, equipment in work spaces, patient rooms, or hallways

Interruptions or distractions

Interruptions or distractions contributed to the event.

INCLUDES: cell phones, pages, side conversations; interruptions during a procedure or while trying to complete a task

EXCLUDES: alarm fatigue (select “Alarm fatigue”)

Lighting Lighting conditions contributed to the event.

INCLUDES: Poor or inadequate lighting; lighting that creates glare

Noise

Noise in the environment contributed to the event.

INCLUDES: ambient noise levels from construction, equipment, radios, televisions

EXCLUDES: alarm fatigue (select “Alarm fatigue”), side conversations (select “Interruptions or distractions”)

Provider or staff fatigue

Fatigue that influenced concentration, judgment, or focus, of provider or staff involved in the event contributed to the event.

EXCLUDES: patient fatigue (select applicable “Patient” factors); alarm fatigue (select “Alarm fatigue”)

Provider or staff health issues

Health issues that influenced concentration, judgment, or focus of provider or staff involved in the event contributed to the event.

EXCLUDES: patient health issues (select applicable “Patient” factors)

Provider or staff stress

Stress that influenced concentration, judgment, or focus of provider or staff involved in the event which contributed to the event.

EXCLUDES: stress experienced by patients (select applicable “Patient” factors)

Work area design and specifications

Work area design and/or specifications contributed to the event.

INCLUDES: layout of work area; traffic patterns; location of supplies and equipment; size of doors, rooms or hallways; obstructed visibility

EXCLUDES: device or supply design or function (select applicable “Device or supply” factors)

Other (please describe)

Any other factor related to human or environmental factors, not included in the list above, contributed to the event.


Organizational Factor Definition

Adequacy of budget

An inadequate budget contributed to the event.

INCLUDES: unit budget; facility budget

Assignment or work allocation

Conditions related to staff assignment or work allocation contributed to the event.

INCLUDES: delegation of task or care to inadequately prepared staff; inappropriate staff assignment; staff assigned to the wrong unit or patient; temporarily assigned internal facility staff (e.g., relief, float, resource, travelers)

EXCLUDES: lack of staff understanding, technical skill, clinical knowledge (select “Staff competencies”); inadequate or disproportionate staffing levels, chronic or acute staffing problems, insufficient numbers and/or types of staff for patient care needs (select “Staffing levels”)

Clinical supervision

Ineffective supervision during or related to clinical processes contributed to the event.

INCLUDES: inadequate supervision during learning process (e.g., walking away from a resident performing their second central line);inadequate supervision according to facility policy (e.g., anesthesiologist fails to supervise a CRNA according to policy)

EXCLUDES: supervision of non-clinical processes (select “Managerial supervision”); inadequate staff competencies (select “Staff competencies”); tasks performed by untrained or inadequately trained staff (select “Job orientation or training”)

Culture of safety

The facility’s culture of safety (or lack thereof) contributed to the event.

INCLUDES: lack of acknowledgment of the high-risk nature of an organization's activities; an environment where individuals are unable to report errors or near misses without fear of reprimand or punishment; collaboration across ranks is not encouraged to seek solution to patient safety problems; lack of organizational commitment of resources to address safety concerns; behavior or behaviors from providers or staff that undermine a culture of safety, including overt actions such as verbal outbursts and physical threats as well as passive activities such as refusing to perform tasks or uncooperative attitudes (e.g., reluctance or refusal to answer questions, return phone calls or pages, condescending language, impatience with questions or consistently arriving late without regard to team or patient)

Internal reporting

Facility’s internal system for reporting adverse events or unsafe conditions contributed to the event.

INCLUDES: staff were unaware of how to make an internal report, or what should be reported; internal reporting is not consistent

EXCLUDES: facility does not have an internal incident reporting system, or does not analyze internal reports to identify areas of risk (select “Systems to identify risk”)


Factor Definition

Job orientation or training

The inadequacy of the facility’s job orientation or training contributed to the event.

INCLUDES: routine job training; in-service education; competency training; job orientation; availability of training programs

EXCLUDES: lack of staff understanding, technical skill, clinical knowledge (select “Staff competencies”)

Managerial supervision

Ineffective supervision during or related to non-clinical processes contributed to the event.

INCLUDES: general manager supervisory functions (e.g., attendance, accountability)

EXCLUDES: supervision related to clinical processes (e.g., inadequate supervision during learning process or according to facility policy) (select “Clinical supervision”)

Management or leadership skills

Ineffective or inadequate management or leadership skills contributed to the event.

INCLUDES: inaction around staff accountability; lack of knowledge of staff competencies, follow-through; inadequate skills in motivation, change, supervision

Staff competencies

Inadequate staff competencies contributed to the event.

INCLUDES: lack of staff understanding, technical skill, clinical knowledge; staff familiar with policy or procedure, but performed procedure incorrectly

EXCLUDES: competency training (select “Job orientation or training”); delegation of task or care to inadequately prepared staff (select “Assignment or work allocation”); inappropriate staff assignment (select “Assignment or work allocation”)staff assigned to the wrong unit or patient (select “Assignment or work allocation”)

Staffing levels

Staffing levels contributed to the event.

INCLUDES: inadequate or disproportionate staffing levels; chronic or acute staffing problems; inadequate or insufficient numbers and/or types of staff for patient care needs

EXCLUDES: inappropriate staff assignment (select “Assignment or work allocation”)

Systems to identify risk

Inadequate systems to identify risk in the facility contributed to the event.

INCLUDES: facility does not have an internal incident reporting system; internal reports are not analyzed to identify areas of risk; no system in place to identify areas of risk that have not already resulted in an adverse event or harm to a patient

EXCLUDES: staff were unaware of how to make an internal report, or what should be reported (select “Internal reporting”)


Factor Definition

Temporary staffing

Conditions related to the use of temporary staff contributed to the event.

INCLUDES: agency or independent staff filling a short-term position or a vacant shift

EXCLUDES: temporarily assigned internal facility staff (e.g., relief, float, resource, travelers); delegation of task or care to inadequately prepared staff; inappropriate staff assignment; staff assigned to the wrong unit or patient (select “Assignment or work allocation”); inadequate staffing levels, chronic or acute staffing problems, inadequate or insufficient numbers and/or types of staff for patient care needs (select “Staffing levels”); staff was not adequately trained or oriented (select “Job orientation or training”)


Any other factor related to organizational factors, not included in the list above, which contributed to the event.


Policy or procedure Includes order sets, protocols, checklists, policies, and procedures.

Factor Definition

Clarity of policy or procedure

Lack of clarity of a policy or procedure (either as written or understood) contributed to the event.

INCLUDES: order sets, protocols, checklists

Policy or procedure absent

Absence of a policy or procedure contributed to the event.


EXCLUDES: outdated policy or procedure (select "Other policy or procedure factor")

Provider or staff unfamiliar with policy or procedure

Provider’s or staff member’s lack of familiarity with the policy or procedure contributed to the event.

INCLUDES: order sets, protocols, checklists; incomplete understanding; acting based on an older version of the policy or procedure

EXCLUDES: staff familiar with policy or procedure, but performed procedure incorrectly (select “Organizational staff competencies”)

Policy or procedure too cumbersome

Policy or procedure was not adhered to because it was felt to be too cumbersome, which contributed to the event.


Work-around more efficient

Policy or procedure was not followed because a work-around was felt to be more efficient, which contributed to the event.



Any other factor related to procedures or policies, not included in the list above, which contributed to the event.

INCLUDES: outdated policy or procedure; policy or procedure is inconsistent with guidelines from professional associations; policy or procedure is not standardized across units/departments; policy or procedure is inaccurate; policy or procedure is unrealistic; policy or procedure is poorly presented or formatted

EXCLUDES: policy or procedure not followed/compliant (why the policy or procedure was not followed/compliant is the contributing factor)


Patient management Factor Definition

Follow-up care

The follow-up care, or lack thereof, contributed to the event.

INCLUDES: care related to discharge information relayed to other care facility or home; inadequate or inappropriate follow-up care or patient tracking

Initial diagnosis

The initial diagnosis contributed to the event.

INCLUDES: misdiagnosis; incomplete diagnosis; patient self-diagnosis; initially following incorrect diagnostic path, missed diagnosis; diagnoses based on incorrect or inaccurate laboratory values, test results, or missing communication from outside sources

EXCLUDES: Patient self-diagnosis

Response to changing condition or delay in care

Provider or staff response to changing condition or a delay in care contributed to the event.

INCLUDES: delays in treatment related to failure to recognize significance of signs and symptoms, lack of test results, or incorrect or missing information

Risk assessment

Inadequate risk assessment contributed to the event.

INCLUDES: inaccurate assessment; incomplete assessment; untimely assessment; omitted assessment

Treatment or care plan

The treatment or care plan contributed to the event.

INCLUDES: accuracy of plan; plan development; plan implementation; following the plan; accuracy of plan; planned delegation of clinical care

EXCLUDES: patient consent process


Any other factor related to patient management, not included in the list above, which contributed to the event.

INCLUDES: patient consent process

EXCLUDES: two or more prescriptions filled at the same time (captured in medication event additional questions)


Patient Factor Definition

Behavioral status

The patient’s behavioral status contributed to the event.

INCLUDES: patient responses of inappropriate anger; patient demonstrates lack of engagement in care plan

EXCLUDES: dementia (select “Mental status”); cognitive impairment (select "Mental status")

Family dynamics or relationships

The patient’s family dynamics or relationships contributed to the event.

INCLUDES: family contradicting staff instructions; dysfunctional relationship between patient and patient's family

EXCLUDES: relationships or dynamics between staff and patient's family (select applicable "Communication" factors)

Fragile health status

The patient’s fragile health status (i.e., health status that resulted in the patient’s condition being less stable and more vulnerable to variations in care) contributed to the event.

INCLUDES: immunocompromised patients; frail elderly; multiple system failure

EXCLUDES: well-controlled multiple diagnoses (list in “Comorbidities”)

Mental status

The patient’s mental status contributed to the event.

INCLUDES: Alzheimer's Disease and other dementias; any other condition impacting a patient's mental status; cognitive impairments impacting patient's understanding of care and treatment requirements

EXCLUDES: behavioral problems (select "Behavioral status")

Physical limitations

The patient’s physical limitations contributed to the event.

INCLUDES: speech; gait disorders; other limitations that impact a patient's abilities

EXCLUDES: sensory impairment (including hearing, vision, smell, feeling, or other impairments) that impact a patient's ability to react to stimuli (select "Sensory impairment")

Sensory impairment (vision, hearing, balance, etc.)

The patient’s sensory impairment contributed to the event.

INCLUDES: Impairments such as hearing, vision, smell, feeling, or other impairments that impact a patient's ability to react to stimuli.

EXCLUDES: Physical limitations (select "Physical limitations"); cognitive impairment (select "Mental status")


Any other factor related to the patient, not included in the list above, which contributed to the event.

hospital patient safety reporting program data dictionary · the data dictionary provides detailed...

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