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Patient Safety Reporting Program

Hospital Adverse Event Reporting Form

CONFIDENTIAL OR PRIVILEGED: This document contains confidential and privileged patient safety data pursuant to ORS 442.820 to 442.835 and Sections 1, 4 to 6, 8 to 10, and 12, Chapter 686, Oregon Laws 2003. Last updated: May 2015

General Information Please complete each of the tabbed sections for the event you are reporting. When complete, select "Submit" under the last tab. A red dot (•) appearing before a question indicates a required field that must be completed before you can submit the report.

Event date Date discovered

Date quality/risk/patient

safety notified of event.

Event time Use military time (hhmm)

Was this event found upon chart review? Check if ‘yes.’

Time unknown Yes

Patient’s gender Patient’s age

Check one. Please use the patient’s self-identified gender.

In Years Months Weeks Days Hours

Male

Circle one.

Female

Patient’s race Check all that apply.

Patient’s ethnicity

Check one.

American Indian or Alaskan Native

White

Other

Unknown

Hispanic

Not Hispanic

Unknown Asian

Black or African American

Native Hawaiian or Other Pacific Islander

Contact name Contact email address Contact phone Who should we contact for clarification or feedback?

, ext.

Multi-hospital system Facility Name

If your hospital is not part of a multi-hospital system, please indicate 'non-system.'

Oregon Patient Safety Commission

CONFIDENTIAL OR PRIVILEGED: This document contains confidential and privileged patient safety data pursuant to ORS 442.820 to 442.835 and Sections 1, 4 to 6, 8 to 10, and 12, Chapter 686, Oregon Laws 2003. of 10

Harm Category The Harm Category for this event is: Check one. Please answer the questions on page 3 to determine your Harm Category. These questions follow the Harm Category Algorithm developed by NCC MERP. If your event involved more than one event type, please select the highest applicable level of harm.

A. Circumstances that have capacity to cause harm

B. Event did not reach patient (an 'error of omission' does reach the patient)

C. Event reached patient but did not cause patient harm

D. Event reached patient and required monitoring to confirm that it resulted in no harm and/or required intervention to preclude harm

E. Event may have contributed to or resulted in temporary harm but did not require a significant intervention

F. Event may have contributed to or resulted in temporary harm and required a significant intervention

G. Event may have contributed to or resulted in permanent patient harm

H. Event required intervention necessary to sustain life

What was the extent of harm to the patient? 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?

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

I. Event may have contributed or resulted in patient's death



Harm Category

Did an actual adverse event occur?

Circumstances that have the capacity to cause an adverse event

Category A

Did the event reach the patient?*

Did the event contribute to or result

in patient death?

Category I

Was the patient harmed?

Category C

Category D

Was extra monitoring or an intervention to

preclude harm required?

Was an intervention necessary to sustain life

required?

Was the harm permanent?

Category H

Was the harm temporary?

Category G

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

*An error of omission does reach the patient

Which intervention to preclude harm was required? 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)

Did the event require any of the following significant interventions? Check all that apply.

No significant intervention

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 a rescue drug or antidote)

Other significant intervention (please describe)

Category E

Category F

Category B

What prevented the event from reaching the patient? Check one.

Fail-safe/safeguard worked effectively

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

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

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

Unknown

Other (please describe)

Yes

No

No

No

No

No

No

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

No



Event Information Indicate the type of event that you are reporting (select at least one). Events in bold are considered reportable events regardless of harm category.

Once you have selected the event type, scroll down the page and complete the "Additional Event Information" section as well as the additional questions specific to the event type you selected (noted with an * by event type).

Event Type 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.

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 (includes retained surgical items)*

Other event (please describe)

* This event type triggers additional event-specific questions that appear below “Additional Event Information.”



Additional Event Information Event Location Select the location where the event occurred, or originated, regardless of the location in which it was discovered.

Bathroom (toileting, bathing, tub/shower room) Labor and delivery

Behavioral health Mother/baby

Critical care (adult) Operating/procedure room

Critical care (pediatric, NICU) Pharmacy

Day/ambulatory surgery Preop area

Diagnostic/procedure area Post anesthesia care unit

Emergency department Radiology/imaging

Inpatient (adult) Rehab/therapy room

Inpatient (pediatric, nursery) Swing bed

Laboratory (including pathology department and blood bank) Other (please describe)

Relevant surgeries or procedures (Required for Anesthesia, Surgical or other invasive procedure, and Unintended retained foreign object events) Please list surgeries or procedures that preceded the reported event, or during which the reported event occurred (e.g., knee surgery, central line insertion).

Admitting diagnosis Only indicate primary diagnosis. ICD-9/ICD-10 not required.

Relevant comorbidities Please list co-morbidities related to the reported event.

How preventable was the incident? Choose one

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

Was the event associated with HIT (health information technology)? Check one.

Yes – go to page 6

No – go to page 7

IF EVENT TYPE ANESTHESIA, SURGICAL OR OTHER INVASIVE PROCEDURE OR UNINTENDED RETAINED FOREIGN OBJECT:

What was the patient's documented ASA class? Only events involving a procedure for which ASA Class was not determined should mark ‘n/a.’

Class 1 Class 5

Class 2 Unknown

Class 3 n/a

Class 4

Was care provided under emergency circumstances?

Yes

No

Unknown



Type of HIT device involved Check one.

Automated dispensing system (e.g.,

pyxis)

EHR or component of EHR Type of EHR involved

Human interface device (e.g., keyboard, Check one.

monitor/display, speech recognition system)

Laboratory information system, including microbiology and pathology systems

Radiology/diagnostic imaging system (including PACS)

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)



Which of the following describes the circumstances involving the HIT in the event? Check all that apply.

Incompatibility between devices Which problem(s) resulted from the HIT function problem?

HIT function Check all that apply.

HIT maintenance Loss or delay of data Incorrect test results

Hardware failure or problem System returns or stores data that does

not match patient

Image measurement/corruption issue

Image orientation incorrect

Incorrect software programming calculation

Incorrect or inappropriate alert


Network failure or problem

Security, virus, or other malware issue

Unexpected software design issue

Human/device interface or other ergonomics issue

Which human/device interface or ergonomics issue(s) were involved? Check all that apply.

Security, virus, or other malware issue

Unexpected software design issue Hardware location (e.g., awkward placement for use)

Unknown Alert fatigue/alarm fatigue

Other (please describe) Data entry or selection (e.g., entry or selection of incorrect patient, incorrect provider, incorrect drug, incorrect dose)

Information display or interpretation (e.g., font size, color of font, location of information in display screen)


The following event types have additional questions that are available in separate documents on our website.

Anesthesia

Blood or blood product

Contaminated drugs, devices or biologics

Device or medical/surgical supply

Fall

Healthcare-associated infection (HAI)

Maternal

Medication or other substance

Perinatal

Pressure ulcer

Surgical or other invasive procedure

Unintended retained foreign object



Contributing Factors What were the most important contributing factors to this event? Select all factors that apply. Select "No" if the factor does not fit the event. Selecting "Yes" will provide you with a more detailed list of related factors to choose from. If the list does not include an applicable contributing factor, select "other" and briefly describe the factor in the space provided.

Communication Were communication factors involved in this event?

Yes Healthcare team member factors Patient/family factors

No Check all that apply Check all that apply

Across units Culture

Among interdisciplinary teams Language

Between providers and staff Miscommunication

Between supervisor and staff Patient did not use call light

Handoffs, handovers, or shift reports Patient unable to communicate

Hard to read fax or handwriting Understanding discharge instructions or plan

Within units Other (please describe)

With other organizations or outside providers


Device, equipment, and supply Were device, equipment, or supply factors involved in this event?

Yes Device, equipment, or supply factors

No

Check all that apply.

Availability Shortage

Design Use or selection by healthcare provider or staff

Function (e.g., defective, non-working) Use by patient

Maintenance Other (please describe)

Human and environmental Were human or environmental factors involved in this event? Human factors refers to healthcare professionals and staff only. For patient factors, use the Patient Factors category below.

Yes Human and environmental factors

No Check all that apply.

Alarm fatigue Provider or staff fatigue

Clutter Provider or staff health issues

Interruptions or distractions Provider or staff stress

Lighting Work area design and specifications

Noise Other (please describe)



Organizational Were organizational factors involved in this event?

Yes Organizational factors


Adequacy of budget Management or leadership skills

Assignment or work allocation Staff competencies

Clinical supervision Staffing levels

Culture of safety Systems to identify risk

Internal reporting Temporary staffing

Job orientation or training Other (please describe)

Managerial supervision

Policy or procedure Were policy or procedure factors involved in this event?

Yes Policy or procedure factors


Clarity of policy or procedure Policy or procedure too cumbersome

Policy or procedure absent Work around more efficient

Provider/staff unfamiliar with policy or procedure


Patient management Were patient management factors involved in this event?

Yes Patient management factors


Initial diagnosis Risk assessment

Follow-up care


Response to changing condition or delay in care

Treatment or care plan

Patient Were patient factors involved in this event?

Yes Patient factors


Behavioral status Physical limitations

Family dynamics or relationships Sensory impairment (vision, hearing, balance, etc.)

Fragile health status Other (please describe)

Mental status



Review Date review and analysis completed MM/DD/YYYY

Members of the review and analysis team Check all that apply.

Anesthesia provider

Engineering/biomed/materials management

Family/patient/patient representative

Health information technology/information service

Infection control

Nursing management

Nursing staff

Patient safety

Pharmacist(s)

Physician(s)

Quality management

Rehabilitation staff

Respiratory therapy

Risk management

Senior management/administrator


Person hours spent in review Please approximate the combined total number of hours that all individuals involved contributed to the review and analysis of this event.

Who was notified of this event? Check all that apply.

Senior management

Board of directors

Neither of these were notified

Did the review and analysis team have a post-analysis briefing with senior management? Either in person (with the whole team or a single representative) or through a senior leader review of the analysis findings and outcomes.

Yes

No

Who was given written notification of this event? Check all that apply.

Patient Please specify why no written notification was given Check all that apply.

Patient’s representative

None given Written notification pending

No organizational policy

Not required by facility organizational policy

Not required by Commission definitions

Oral disclosure

Unable (please describe)




Summary

Summary, Causes, & Preventive Action Plans

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 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.

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.)

This blank report is intended to be used as a reference only. You cannot submit this form. Please log in to the Patient Safety Reporting Program (PSRP) online system to submit a report (https://psrp.oregonpatientsafety.org)

The following event types have additional questions that are available in separate documents on our website.

Anesthesia

Blood or blood product

Contaminated drugs, devices or biologics

Device or medical/surgical supply

Fall

Healthcare-associated infection (HAI)

Maternal

Medication or other substance

Perinatal

Pressure ulcer

Surgical or other invasive procedure

Unintended retained foreign object

Causes Root cause? Action Plans

Yes No

1.

2.

3.

4.

5.

https://psrp.oregonpatientsafety.org/

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