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NSIR Medication Incident Data Collection Form
Place Holder for Addressograph
Source Facility
HCF Case Record # NSIR Case ID
Reported By: Name: _______________________________________________
Date:
Signature: ____________________________________________
_____________________________________________________
Position: _____________________________________________________
For detailed information on the categories and definitions, please refer to CIHI’s National System for Incident Reporting Minimum Data Set, 2012.
I M PA C T
Description of the Medication Incident (Provide a detailed, factual description of what happened during the medication incident. DO NOT INCLUDE names
or specific details that could lead to the identification of patients/residents, health care providers or the facility.)
Degree of Harm (Mandatory. Select one only. Please see NSIR Algorithm for Categorizing Degree of Harm of Medication Incidents for assistance.)
r Reportable circumstance
A situation that has potential for harm and does not involve a patient/resident.
r Near miss
An incident that has potential for harm is intercepted or corrected prior to reaching the patient/resident.
r None
Outcome is not symptomatic or no symptoms are detected and no treatment is required.
r Mild
Outcome is symptomatic, symptoms are mild, loss of function or harm is minimal or intermediate but short term and no or
minimal intervention (for example, extra observation, investigation, review or minor treatment) is required.
r Moderate
Outcome is symptomatic, requiring intervention (for example, additional operative procedure, additional therapeutic treatment) or an increased length of stay, or causing minor permanent, long-term harm or loss of function.
r Severe
Outcome is symptomatic, requiring life-saving intervention or major surgical/medical intervention, or shortening life expectancy or causing major permanent, long-term harm or loss of function.
r Death
On balance of probabilities, the incident was considered to have played a role in the patient’s/resident’s death.
Potentially Severe Incident (N/A when Degree of Harm = Severe or Death)
Could this medication incident have resulted in permanent harm or death to the patient/resident if not for actions and/or strategies taken to mitigate harm?
r Yes
r No
r Do not know
DISCOVERY
Ward/Unit (Mandatory) (The functional area within the facility in which the incident occurred, for example the Emergency Dept., 5 East, Ward B.)
HH
MM
24-Hour Clock
□□ □□
HH
MM
Time
Period
MMDD
□□ □□
r 08:00–11:59
r 12:00–15:59
r 16:00–19:59
r 20:00–23:59
r 00:00–03:59
r 04:00–07:59
r Do not know
Time
Period
□□□□ □
□ □□
OR
Date YYYY
MMDD
24-Hour Clock
OR
OCCURRED*
YYYY
Precise
Time
Date
Precise
Time
□□□□ □
□ □□
AND
DETECTED
(Mandatory)
AND
Date and Time of Incident (Select Date AND either Precise Time OR Time Period)
r 08:00–11:59
r 12:00–15:59
r 16:00–19:59
r 20:00–23:59
r 00:00–03:59
r 04:00–07:59
r Do not know
*If multiple administrations, state date and time or time period of initial occurrence.
Canadian Institute for Health Information 2012 CONFIDENTIAL DOCUMENT. This document cannot be shared or distributed
except in accordance with the terms of the CIHI Confidentiality Agreement.
Health Care Provider(s) and/or Others Who Detected and/or Were Involved in Incident (Select all that apply.)
Nursing
Practical nurse (LPN/RPN)
Registered nurse
Registered psychiatric nurse
Nurse practitioner
Clinical nurse specialist
Clinical trials nurse
Nursing instructor
Nursing—unspecified
Pharmacy staff
Pharmacy support staff
Pharmacy technician
Pharmacist
Pharmacy—unspecified
Medicine
Resident
Detected Involved
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
Consulting physician
Attending physician
Medicine—unspecified
Health Care Provider
Administrative staff
Clerical staff
Clinical perfusionist
Clinical support staff
Dentist
Detected Involved Diagnostic imaging staff
Health care aide
r
r
Laboratory staff
r
r
Materials management staff
r
r
Midwife
r
r
Optometrist
Detected Involved
Paramedic/ambulance staff
r
r
r
r
r
r
r
r
Detected
Involved
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
r
Student—Health Disciplines Detected
Medical student
Nursing student
Pharmacy student
Student—unspecified
Involved
r
r
r
r
Therapy Detected
Occupational therapist
Physiotherapist
Radiation therapist
Respiratory therapist
Therapy—unspecified
r
r
r
r
Involved
r
r
r
r
r
Other
Detected
Family member/caregiver
Patient/resident
Other staff
Do not know
r
r
r
r
r
Involved
r
r
r
r
r
r
r
r
P A T I E N T (N/A when Degree of Harm = Reportable circumstance. Mandatory when Degree of Harm = None to Death.)
Month and Year of Birth
D E TA I L S
□□ □□□□
M
M
Y
Y
Y
Y
Patient/Resident Sex
r Female r Male r Undifferentiated r Do not know
Medication/IV Fluid Use Process (Mandatory. Select one only. The point in the process of the medication-use system that is most responsible for the incident.)
r Supplying
r Prescribing
r Preparing/dispensing
r Delivery
r Storage/location r Order documentation r Presentation/packaging r O
rder verification
(pre-administration)
r Administration
r Monitoring
(post-administration)
r Advising/counselling
r Other
Medication/IV Fluid Problem (Mandatory. Select one only. The nature of the incident whether or not it reached the patient/resident and/or caused harm.)
r Expired/deteriorated product
r Extra dose
r No order
r Omitted dose
r Wrong formulation
r Wrong patient/resident
r Wrong product
r Wrong quantity
r Wrong rate/frequency
r Wrong route/technique
r Wrong sequence
r Wrong storage/location
r Wrong time
r Other
Repeated Administrations (N/A when Degree of Harm = Reportable circumstance or Near miss)
r Yes
Was the same medication administered more than once before the medication incident was detected?
r No
r Do not know
Contributing Factor(s) (Mandatory. Please read all options before selecting.)
Behavioural Factors
r Attention issues—failure to remember
r Fatigue/exhaustion
r Stress
r Behavioural factors—unspecified
r Non-supportive working environment
r Quality control—double/independent
check processes
r Workflow design
r Organizational factors—unspecified
Communication Factors
Patient/Resident Factors
r Electronic documentation—incomplete,
r Behavioural factors
r Cognitive factors
r Communication factors
r Emotional factors
r Known drug allergy
r Patho-physiological/disease-related factors
r Performance factors
r Social/family factors
r Patient/resident factors—unspecified
incorrect or inaccessible
r Language barrier
r Transcription inaccuracy
r Verbal—incomplete or incorrect
r Written/printed information/medical history—
incomplete, incorrect or illegible
r Written/printed medication orders—
incomplete, incorrect or illegible
r Communication factors—unspecified
Drug Product Confusion
r Look-alike drug products
r Spelled/sound-alike drug product names
r Drug product confusion—unspecified
Knowledge-Based/Problem-Solving
r Insufficient drug interaction knowledge
r Insufficient knowledge
r Knowledge-based/problem-solving—
unspecified
Organizational Factors
r Drug delivery process
r Drug inventory process
r Drug storage conditions
r Inadequate staff training
r Medication reconciliation process
Performance Factors
r Application of poor procedure/protocol
r Calculation error
r Data entry error
r Delay in action
r Drug preparation error
r Incorrect use of infusion pump
r Manual dexterity/technical skill problem
r Misapplication of standard
procedure/protocol
r Workaround/shortcut
r Performance factors—unspecified
Physical Environment and Equipment
r Automated dispensing systems
r Computer/fax equipment—hardware,
software, network failure
r Computerized prescriber order entry (CPOE)
r Distractions/frequent interruptions
r Equipment/supplies
r Infusion pump malfunction
r Lighting
r Other medication administration device malfunction
r Workspace design
r Physical environment and equipment factors—
unspecified
Products, Technology and Infrastructure
r Drug product information—missing, incomplete,
incorrect and/or misleading
r Drug product labelling—pharmacy
r Drug product labelling—manufacturer
r Drug product off-label use
r Infusion pump design
r Packaging/container design—pharmacy
r Packaging/container design—manufacturer
r Products, technology and infrastructure—
unspecified
Resources/Workload
r Agency/temporary/relief/float staff
r Change of shift
r Emergency situation
r Hours of work
r Inexperienced staff
r Insufficient/unavailable staff
r Workload
r Resources/workload—unspecified
r Other
r Do not know
Canadian Institute for Health Information 2012 CONFIDENTIAL DOCUMENT. This document cannot be shared or distributed
except in accordance with the terms of the CIHI Confidentiality Agreement.
NSIR Medication Incident Data Collection Form 2 of 4
Chemotherapy Regimen:
D r u g (List all relevant information associated with the drug product(s) involved in the medication incident.)
Drug #1
Drug #2
Drug #3
Drug #4
Name of Drug Product (generic
or brand) OR List of Extemporaneous Ingredients OR DIN
If Problem = Wrong product
Strength
r Correct
r Incorrect
r Correct
r Correct
r Incorrect
r Correct
Correct
Correct
Correct
(Incorrect dosage form only applicable Incorrect
when Problem = Wrong formulation)
Correct
Incorrect
Incorrect
Incorrect
Correct
Correct
Correct
(Incorrect route only applicable when
Problem = Wrong route/technique)
Incorrect
Incorrect
Incorrect
Dosage Form
Route of Administration
Correct
r Incorrect
Incorrect
r Incorrect
Batch/Lot Number
Investigation
Patient/Resident Informed of Incident (Select one only. N/A when Degree of Harm = Reportable circumstance.)
r Yes, the patient/resident, the patient’s/resident’s
family or the substitute decision-maker was informed
Likelihood of Recurrence (Select one only.)
r No, neither the patient/resident nor the patient’s/resident’s
family nor the substitute decision-maker was informed
r Almost certain
r Likely
r Possible
r Unlikely
r Do not know
r Rare
r Do not know
Interventions Required (Select all that apply. N/A when Degree of Harm = Reportable circumstance or Near miss.)
r None required
r Cognitive, psychological and
sensory therapeutic interventions
Diagnostic interventions
Physical/physiological therapeutic interventions
r Clinical laboratory interventions
r Diagnostic imaging interventions
r Monitoring vital signs
r Other known diagnostic interventions
r Diagnostic interventions—unspecified
r Drug, intravenous fluid or transfusion therapy
r Medical interventions
r Surgical interventions
r Physical/physiological therapeutic interventions—unspecified
r Other health care interventions
r Do not know
Extended Length of Stay (Actual number of additional days in the facility required as a result of
the medication incident. N/A when Degree of Harm = Reportable circumstance, Near miss or None.)
Number of days
Unplanned Admission/Readmission (N/A when Degree of Harm = Reportable circumstance, Near miss or None.)
Was the patient/resident admitted or readmitted due to the incident?
r Yes r No
r Do not know
Root Cause Analysis Status (Select one only. N/A when Degree of Harm = Reportable circumstance.)
r None planned r Planned
r Ongoing
r Completed
r Do not know
Future Strategies/Recommendations (Include preventive activities planned or implemented within the organization and recommendations to minimize
future harm.)
Actions or Circumstances That Prevented Harm (Only applicable when Degree of Harm = Reportable circumstance Near miss or None. Include
informal actions or procedures that led to a potentially dangerous situation being detected, understood and corrected in time, preventing the incident from harming
the patient/resident.)
Canadian Institute for Health Information 2012 CONFIDENTIAL DOCUMENT. This document cannot be shared or distributed
except in accordance with the terms of the CIHI Confidentiality Agreement.
NSIR Medication Incident Data Collection Form 3 of 4
Algorithm for Categorizing Degree of
Har m of Medication Incidents
Medication Incident
Any preventable circumstance or event that may cause or lead to inappropriate medication use or patient harm while the medication/IV fluid is in the control of the health
care professional, patient or consumer.1
Harm
Impairment of structure or function of the body and/or any deleterious effects arising
therefrom. Harm includes disease, injury, suffering, disability and death.2
Intervention
An act or actions intended to interrupt the course of events that are in progress.2
Sources
1. Adapted from D. D. Cousins, “Developing a Uniform
Reporting System for Preventable Adverse Drug
Events,” Clinical Therapeutics 20, Suppl. C (1998):
pp. C45–C59.
2. Adapted from the World Health Organization,
Final Technical Report for the Conceptual Framework
for the International Classification for Patient Safety
v1.1 (Geneva, Switzerland: WHO, 2009).
An event or circumstance that could
have resulted or did result in
unnecessary harm
Reportable
Circumstance
NO
Did the incident/event involve
a patient/resident?
YES
Near Miss
NO
Did the incident reach
the patient/resident?
YES
None
NO
Was the patient/resident harmed?
YES
Did the incident play a role in
the patient’s/resident’s death?
YES
Death
YES
Severe
YES
Moderate
NO
Did the incident require major
surgical/medical/life-saving
intervention or was there major
permanent harm?
NO
Mild
(minimal symptoms/harm,
no or minimal intervention)
NO
Did the incident require
more than minimal intervention
or an increased length of stay
or cause minor permanent harm?
Canadian Institute for Health Information 2012 CONFIDENTIAL DOCUMENT. This document cannot be shared or distributed
except in accordance with the terms of the CIHI Confidentiality Agreement.
NSIR Medication Incident Data Collection Form 4 of 4