EVENTS REPORTING POLICY & PROCEDURE

‫اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑﯿﺔ اﻟﺴﻌﻮدﯾﺔ‬

Kingdom of Saudi Arabia Ministry of Health

‫وزارة اﻟﺻﺣﺔ‬

General Directorate of Health Affairs Makkah AL-Mukaramah Region

‫اﻟﻣدﯾرﯾﺔ اﻟﻌﺎﻣﺔ اﻟﺷﺋون اﻟﺻﺣﯾﺔ‬ ‫ﺑﻣﻧطﻘﺔ ﻣﻛﺔ اﻟﻣﻛرﻣﺔ‬

 It is allowed ONLY to access and keep this document with its owner and to whom it is applicable.  Electronic copy is controlled under document control procedure. Hard copy is under responsibility of its owner

EVENTS REPORTING POLICY & PROCEDURE 1- Purpose / Rational: 1-1Establish system and set responsibilities and accountabilities regarding: 1-1-1 Reporting of patient safety events happening during healthcare provision, 1-1-2 Events data analysis and 1-1-3 Events Information communication. 1-2Ensure complying with the following: 1-2-1 Confidentiality of events information, 1-2-2 Non-punitive response to events reporting and 1-2-3 Communication openness between healthcare staff about events information. 1-3Consider the platform for quality control and risk management to ensure availability of quantitative and qualitative data for quality improvement and risk reduction strategies.

2- Scope of Application: 2-1 The process of reporting the events occurred within the healthcare facilities. 2-2 It starts by discovering the event by any staff (discoverer). 2-3 It ends by Decision making for improvement at the level of the General Directorate. 2-4 Applied to all healthcare facilities and staff

3-

References: 3-1 Ministry of Health (MOH) rules and regulations. 3-2 Central Board for Accreditation of Health Institutes (CBAHI) standards. 3-3 Joint Commission International (JCI) standards. 3-4 ISO 9001:2008 requirements. 3-5 Users guide ver1.1, AHRQ common formats for patient safety organizations. www.ahrq.gov

4- Definitions: 4-1 Blood/Blood product related event: Patient safety concerns include incidents, near-misses, and unsafe conditions related to a blood or blood product involves the processing and/or administration of blood or a blood product (see annex 4 for details). 4-2 Common formats: describe the technical requirements pertaining to the collection and reporting of patient safety events data (see annex 3 for details of the forms). 4-3 Device/supply related event: Patient safety concerns include incidents, near misses, and unsafe conditions related to a device or medical/surgical supply involves a defect, failure, or incorrect use of a device (see annex 4 for details). 4-4 Event specific forms: address the most commonly-occurring types of patient safety events. They are intended to supplement the information collected on the generic forms (HERF, PIF, and SIR) (see annex 3). 4-5 Fall related event: Patient safety concerns include only incidents of a fall that is a sudden, unintended, uncontrolled, downward displacement of a patient’s body to the ground or other object (see annex 4 for details). Code 306-PP-011 Issue Nu :1 Issue Date: 01/08/1432 Activation Date:: 01/10/1432 Revision Date:: 01/08/1434 Page Nu:1 / 6







EVENTS REPORTING POLICY & PROCEDURE 4-6 Generic forms: Structured and narrative questions on the generic forms provide for capturing of basic information along the spectrum of harm, including events resulting in harm, or no-harm that reached the patient, near misses (close calls), and unsafe conditions. 4-7 Healthcare Event Report Form (HERF): The first generic common formats form to be filled in the event reporting system by the reporter upon discovery of an event, either incident, near miss or unsafe condition. 4-8 Healthcare Associated Infection (HAI): A healthcare-associated infection (HAI) is a localized or systemic condition resulting from an adverse reaction to the presence of an infectious agent(s) or its toxin(s). It is acquired during the course of receiving treatment for other conditions within a healthcare setting, with no evidence that the infection was present or incubating at the time of admission (except surgical site infection (SSI) (see annex 4 for details). 4-9 Incident: A type of a patient safety event that reaches the patient, whether or not the patient was harmed. 4-10 Medication & other substance related event: Patient safety concerns include incidents, near misses, and unsafe conditions in relation to the processing and/or administration of medication or other substance event involves medications (Prescription or over-the-counter or Compounded preparations), biological products (Vaccines or Other biological products (e.g., thrombolytics)), nutritional products, or medical gases. This pertains to both hospital inpatient and outpatient pharmacies, located within the hospital (see annex 4 for details). 4-11 Near miss (Close call): A type of patient safety event that did not or could not reached the patient. 4-12 Patient Information form (PIF): The second generic common formats form to be filled in the event reporting system ONLY for “incident” type of event (see annex 3). 4-13 Perniatal mortality related event: Patient safety concerns include only incidents related to a perinatal event involves an adverse outcome occurring to the mother, fetus(es), or neonate(s) during the perinatal period. The perinatal period extends from the 20th week of gestation through 4 weeks (28 days) postpartum (see annex 4 for details). 4-14 Pressure ulcer related event: Patient safety concerns include only incidents related to a pressure ulcer that is a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction (see annex 4 for details). 4-15 Sentinel (Serious) event: Unexpected death, loss of limb or function, serious physical or psychological injury or the risk thereof. The risk thereof is a near miss (close call) event that did not lead to unexpected death, loss of limb or function, serious physical or psychological injury but has the great possibility to do if repeated. The serious physical or psychological injury results in hospitalization for more than 15 days or discharge from the hospital with this injury. For serious events list (see the details in annex 4). 4-16 Summary Information Report (SIR): The last generic common formats form to be filled in event reporting system. (see annex 3)

Code 306-PP-011 Issue Nu :1 Issue Date: 01/08/1432 Activation Date:: 01/10/1432 Revision Date:: 01/08/1434 Page Nu:2 / 6







EVENTS REPORTING POLICY & PROCEDURE 4-17 Surgical & anesthesia related event: Patient safety concerns include incidents and near misses in relation to surgery or other invasive procedures (e.g., colonoscopy) &/or the administration of anesthesia. They also pertain to both inpatient and outpatient procedures occurring within the hospital. (see annex 4 for details) 4-18 Unsafe condition: A type of patient safety event in relation to any circumstance that increases the probability of a patient safety event.

5- Policy: 5-1 All staff should be encouraged and accountable to report any discovered deviation in the performance or process outputs or outcomes of healthcare services whether or not led to incident. 5-2 The event reporting should use the common formats guided by the quick user guide (annex 2). 5-3 The Common Formats are not an attempt to replace any current mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other reporting/recording system in the healthcare facility. They are intended to facilitate the collection, aggregation, and use of patient safety data regardless of the type of reporting system. 5-4 If the event is discovered during its occurrence, the discoverer should be keen first to contain the event and do his/her best to prevent its consequences. 5-5 Communication of the events’ information should be encouraged between the staff with emphasis on “how” and “results” more than “what” and “who”. 5-6 Common formats data should be validated by the quality officer for their reliability. 5-7 Some of the data entered in the common formats are highlighted by shading to indicate their confidentiality for the healthcare facility use ONLY and not to be shared outside. 5-8 Other un-shaded data should be communicated to the concerned staff at the directorate or general directorate level for sharing experiences and lesson learning. 5-9 Sentinel (Serious reportable) events – as mention in annex 4 - should have a root cause analysis by multidisciplinary team maximum within 7 working days followed by thorough and credible action plan maximum within 45 days.

6- Procedure / Steps: as shown in the process map (annex 1) A- HERF Reporting on a daily basis: 6-1 Any staff can fill the HERF either manually (annex 3) or electronically via www.mrhb-cf.org . 6-2 The supervisor, HOD or the director of the department where the HERF is filled manually should collect the HERFs as soon as possible - maximum within 24 working hours from date of reporting and take appropriate action to mitigate the risk. 6-3 The supervisor, HOD or the director should deliver the manually filled HERFs to the quality department within the working hours - maximum within 48 hours from date of reporting. 6-4 The quality officer should validate the manual or electronically HERF’s data for their reliability and do the needed correction or cancellation. 6-5 The quality coordinator/officer enters the valid HERF’s data into the database via www.mrhbcf.org . Code 306-PP-011 Issue Nu :1 Issue Date: 01/08/1432 Activation Date:: 01/10/1432 Revision Date:: 01/08/1434 Page Nu:3 / 6







EVENTS REPORTING POLICY & PROCEDURE B- Common formats completion on a daily basis: 6-6 The quality coordinator with the concerned departments complete manually the related specific formats (if needed) according to the event category (see annex 2). 6-7 The quality coordinator fills in the patient information form (PIF) if the event is of “incident” type (annex 3). 6-8 After completion of HERF, PIF and the specific event forms, the quality coordinator complete the summary information report (SIR) form for every event (annex 3). 6-9 Quality officer should valid the events data in the filled common formats for reliability and should do the correction or cancellation when needed. 6-10 Quality coordinator enter the valid common formats’ data into the web site: www.mrhb-cf.org.

C- Healthcare Events Reporting Follow-Up: 6-11 The quality director should feed-back the concerned staff or department ASA about the event’s information for appropriate action, if needed. 6-12 If the reported event is matching the criteria of a sentinel (serious reportable) event (see annex 4), multidisciplinary team (MDT) from the concerned department(s)/discipline(s) does a root cause analysis (RCA) within 7 working days. 6-13 The assigned MDT should complete issuing thorough and credible action plan within 45 working days. 6-14 The quality coordinator with the concerned department(s)/discipline(s) must do the appropriate corrective/preventive action, if needed. 6-15 The quality officer must issue a monthly report after events’ data analysis.

D- Events information communication: 6-16 The quality director should submit a quarterly report from the web-site www.mrhb-cf.org to the quality council for opportunities for improvement (OFI). 6-17 The directorate quality officer analyzes the events information of the related healthcare facilities for lessons learnt using the web-site: www.mrhb-cf.org . 6-18 The directorate quality officer issues a quarterly report for events trends and OFI from the web-site www.mrhb-cf.org . 6-19 The health affairs directorate director constructively feed-back to the concerned health facilities about their events information. 6-20 The health affairs directorate executive council takes the appropriate decisions for quality improvement and enhancement safety.

7- Form/s used – Resources needed: (annex 3) 7-1 Generic forms: 7-1-1 HERF 7-1-2 PIF 7-1-3 SIR Code 306-PP-011 Issue Nu :1 Issue Date: 01/08/1432 Activation Date:: 01/10/1432 Revision Date:: 01/08/1434 Page Nu:4 / 6







EVENTS REPORTING POLICY & PROCEDURE 7-2 Event specific forms 7-2-1 Blood/Blood Product Event form 7-2-2 Device/Medical or Surgical Supply Event form 7-2-3 Fall event form 7-2-4 HAI Form 7-2-5 Perinatal Mortality event form 7-2-6 Pressure Ulcer event form 7-2-7 Medication or Other Substance event form 7-2-8 Surgical/Anesthesia event form 7-3 Common formats portal linked with www.mrhb.gov.sa 7-4 HERF-Up form

8- Records:

Responsibility Retention time 8-1 Filled manual common formats Hospital quality dep. 3 yeas 8-2 Manual Sentinel event Root Cause Analysis & Action plans Hospital quality dep. 3 yeas 8-3 Healthcare facility events e-data base Hospital quality dep. Long life 8-4 Regional-wide events e-data base Directorate quality dep. Long life

9- Key Performance Indicator/s: 9-1 Rate of events reporting. 9-2 Turnaround time of root cause analysis of sentinel event. 9-3 Turnaround time of closure of the corrective/preventive actions.

10- Annexes: 11-1 Event reporting process mapping. (annex 1) 11-2 Common formats quick user guide. (annex 2) 11-3 Common formats forms (annex 3) 11-4 Events categories descriptions (annex 4)








EVENTS REPORTING POLICY & PROCEDURE Preparation, Revision & Approval Name Prepared by

Dr. Ahmed AL-Adawy

Position & Dept.

Signature

Date

Quality Consultant

Reviewed by

Dr. Mohamed Felimban

Assist DG for Quality

Approved by

Dr. Khalid O. Dhafar

Director General

Revision Item No.

Description

Date


Kingdom of Saudi Arabia


Ministry of Health

‫وزارة اﻟﺼﺤﺔ‬


‫اﻟﻤﺪﯾﺮﯾﺔ اﻟﻌﺎﻣﺔ اﻟﺸﺌﻮن اﻟﺼﺤﯿﺔ‬ ‫ﺑﻤﻨﻄﻘﺔ ﻣﻜﺔ اﻟﻤﻜﺮﻣﺔ‬


Annex (1) EVENT DISCOVERY

Event Reporting Process High Level Flow Chart

1

2

3

4

END Code 306-FC-PP-011-01 Issue Nu :1 Issue Date: 01/05/1431 Activation Date:: 01/07/1431 Revision Date:: 01/05/1433 Page Nu:1 / 2



Ministry of Health





Annex (1) continue

Code 306-FC-PP-011-01 Issue Nu :1 Issue Date: 01/05/1431 Activation Date:: 01/07/1431 Revision Date:: 01/05/1433 Page Nu:2 / 2



Ministry of Health





Annex (2)

Code 306-FC-PP-011-02 Issue Nu :1 Issue Date: 01/05/1431 Activation Date:: 01/07/1431 Revision Date:: 01/05/1433 Page Nu:1 / 1



Ministry of Health





ANNEX 3: COMMON FORMATS FORMS

ANNEX 3: COMMON FORMATS FORMS




Ministry of Health



‫اﻟﻤﺪﯾﺮﯾﺔ اﻟﻌﺎﻣﺔ ﻟﻠﺸﺌﻮن اﻟﺼﺤﯿﺔ‬ ‫ﺑﻤﻨﻄﻘﺔ ﻣﻜﺔ اﻟﻤﻜﺮﻣﺔ‬

HEALTHCARE EVENT REPORTING FORM (HERF) Confidential (No Duplication or Photocopy is Allowed and Not A Part of The Medical or Staff file) Not A Legal Document, Used ONLY For Study And Quality Improvement Purposes Event ID #; Initial Report Date (HERF Q8): 1. What is being reported?

DD

MM

YY

2. Was there any evidence of harm to the patient at time of this report? Check ONE:

a. Incident": A patient safety event that reaches the patient, whether or not the patient was harmed.

a.  Yes

b. "Near Miss": A patient safety event that did not or could not reached the patient

b.  No

c.  Unknown

3. Event Discovery Date: __ __/__ __/_____  Unknown

c.  Unsafe Condition: Any circumstance that increases the probability of a patient safety event

DD

MM

YYYY

4. Event Discovery Time: __ __:__ __

d. Others

 Unknown

HH

(24h)

MM

5. Briefly describe the event or unsafe condition that exist:

6. Where did the event occur or unsafe condition exist? DESCRIBE LOCATION: 7. What type of event is being reported? CHECK ALL THAT APPLY a.  Anesthesia

f.  Medication & Other Substance

b.  Blood, Blood Products

g.  Perinatal

c.  Device and Medical or Surgical Supply

h.  Pressure Ulcer

d.  Fall

i.  Surgical and Other Invasive Procedure (except Perinatal )

e.  Healthcare-Associated Infection

j.  Other: PLEASE SPECIFY____________________________

Report AND EVENT REPORTER INFORMATION 8. Report Date:

DD

10. Reporter's Name:

9.  Anonymous Reporter

__ __/__ __/________ MM

YYYY

__________________

____________________

FIRST

11. Mobile Number:

___________________________

MIDDLE

________________________

LAST

12. E-mail Address:

_________________________

13. Reporter's Position Title: _____________________________________________________________________ PATIENT INFORMATION (COMPLETE ONLY IF 'INCIDENT"): 14. How many patients did the incident REACH? ___________________ ENTER NUMBER

15. Patient's Name:

__________

___________

FIRST

16. Patient's Date OF Birth:

__ __/__ __/________ DD

18. Patient's Gender:

MIDDLE

MM

a.  Male

___________________ LAST

17. Medical Record#: ______________

YYYY

ENTER NUMBER

b.  Female

If the incident involved more than one patient, PLEASE COMPLETE A PATIENT INFORMATION FORM (PIF) FOR EACH PATIENT. Highlighted fields are used collected for facility use only.

Thank you for completing these questions

Code 306-FO-PP011-01 Issue Nu : 8 Issue Date: 01/08/1432 Activation Date:: 01/10/1432 Revision Date:: 01/08/1434 Page Nu:1 / 1

‫‪Kingdom of Saudi Arabia‬‬

‫اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑﯿﺔ اﻟﺴﻌﻮدﯾﺔ‬ ‫وزارة اﻟﺼﺤﺔ‬

‫‪Ministry of Health‬‬

‫اﻟﻤﺪﯾﺮﯾﺔ اﻟﻌﺎﻣﺔ ﻟﻠﺸﺆون اﻟﺼﺤﯿﺔ‬

‫‪General Directorate of Health Affairs‬‬ ‫‪Makkah AL-Mukaramah Region‬‬

‫ﺑﻤﻨﻄﻘﺔ ﻣﻜﺔ اﻟﻤﻜﺮﻣﺔ‬

‫ﻧﻤﻮذج اﻹﺑﻼغ ﻋﻦ ﺣﺎدﺛﺔ ﺑﺎﻟﺮﻋﺎﯾﺔ اﻟﺼﺤﯿﺔ )‪(HERF‬‬ ‫وﺛﯿﻘﺔ ﺳﺮﯾﺔ )ﻏﯿﺮ ﻣﺴﻤﻮح ﺑﺎﻟﻨﺴﺦ أو اﻟﺘﺼﻮﯾﺮ وﻻ ﺗﻌﺘﺒﺮ ﻣﻦ ﻣﺤﺘﻮﯾﺎت ﻣﻠﻔﺎت اﻟﻤﺮﺿﻰ أو ﻣﻠﻔﺎت اﻟﻌﺎﻣﻠﯿﻦ‬ ‫ﻻ ﺗﺴﺘﺨﺪم ﻛﻤﺴﺘﻨﺪ ﻗﺎﻧﻮﻧﻲ‪ ،‬ﻓﻘﻂ ﻟﺪراﺳﺔ وﺗﺤﺴﯿﻦ اﻟﺠﻮدة‬ ‫;‪Event ID #‬‬ ‫‪Initial Report Date (HERF Q8):‬‬ ‫‪YY‬‬

‫‪MM‬‬

‫‪DD‬‬

‫‪ .١‬ﻣﺎذا ﯾﺘﻢ اﻹﺑﻼغ ﻋﻨﮫ؟‬ ‫أ‪.‬‬

‫‪" ‬ﺣﺎدﺛ ﺔ"‪ :‬وھ ﻰ ﻣ ﺎ ﻗ ﺪ ﯾﺼ ﻞ ﻟﻠﻤ ﺮﯾﺾ ﺳ ﻮاء أدى أو ﻟ ﻢ ﯾ ﺆدى ذﻟ ﻚ‬

‫‪ -٢‬ھﻞ ھﻨﺎك ﺷﻮاھﺪ ﻋﻠﻰ أذى ﺣﺪث ﻟﻠﻤﺮﯾﺾ وﻗﺖ‬ ‫ﻛﺘﺎﺑﺔ ھﺬا اﻟﺘﻘﺮﯾﺮ؟‬

‫ﻟﺤﺪوث أذى ﻟﻠﻤﺮﯾﺾ‪.‬‬

‫أ‪  .‬ﻧﻌﻢ‬

‫ب‪ "  .‬ﺣﺎدﺛ ﺔ ﺗ ﻢ ﺗﻔﺎدﯾﮭ ﺎ"‪ :‬ھ ﻲ اﻟﺘ ﻲ ﻗ ﺪ ﺗﻀ ﺮ ﺑ ﺎﻟﻤﺮﯾﺾ وﻟﻜﻨﮭ ﺎ ﻟ ﻢ ﺗﺼ ﻞ‬

‫ج‪  .‬ﻏﯿﺮ ﻣﻌﺮوف‬

‫ب‪  .‬ﻻ‬

‫‪ -٣‬ﺗﺎرﯾﺦ اﻛﺘﺸﺎف اﻟﺤﺎدث_____ ‪_____/__ __/‬‬

‫ﻟﻠﻤﺮﯾﺾ‪.‬‬

‫‪ ‬ﻏﯿﺮ ﻣﻌﺮوف‬

‫ج‪"  .‬ﺣﺎﻟﺔ ﻏﯿﺮ آﻣﻨﺔ"‪ :‬ھﻲ ﻣﺎ ﯾﺰﯾﺪ ﻣﻦ اﺣﺘﻤﺎل وﻗﻮع ﺣﺎدث ﯾﻌﺮض ﺳﻼﻣﺔ اﻟﻤﺮﯾﺾ ﻟﻠﺨﻄﺮ‬

‫ﯾﻮم‬

‫ﺷﮭﺮ‬

‫‪ -٤‬وﻗﺖ اﻛﺘﺸﺎف اﻟﺤﺎدﺛﺔ‪__ __:___ __ :‬‬

‫د‪  .‬أﺧﺮى‬ ‫‪ .٥‬وﺻﻒ ﻣﻮﺟﺰ ﻟﻠﺤﺎدﺛﺔ أو ﻟﻠﺤﺎﻟﺔ ﻏﯿﺮ اﻵﻣﻨﺔ‪:‬‬

‫‪ ‬ﻏﯿﺮ ﻣﻌﺮوف‬

‫اﻟﺴﺎﻋﺔ‬

‫ﺳﻨﺔ‬ ‫)‪٢٤‬ﺳﺎﻋﺔ(‬

‫دﻗﯿﻘﺔ‬

‫‪ .٦‬ﻣﺎ ھﻮ ﻣﻮﻗﻊ ﺣﺪوث اﻟﺤﺎﻟﺔ‪:‬‬ ‫‪ .٧‬ﻣﺎ ھﻮ ﻧﻮع اﻟﺤﺎدﺛﺔ اﻟﻤﺒﻠﻎ ﻋﻨﮭﺎ؟ ﺗﺤﻘﻖ ﻣﻦ ﺟﻤﯿﻊ ﻣﺎ ﯾﻠﻰ‪:‬‬

‫‪ f‬أدوﯾﺔ وﻣﻮاد أﺧﺮى‬ ‫‪g‬ﺣﻮل اﻟﻮﻻدة‬ ‫‪ h‬ﻗﺮﺣﺔ‬ ‫‪ i‬ﺗﺪﺧﻼت ﺟﺮاﺣﯿﺔ أو ﻏﯿﺮ ذﻟﻚ ) ﻣﺎ ﻋﺪا ﺣﻮل اﻟﻮﻻدة(‬ ‫‪j‬ﻏﯿﺮ ذﻟﻚ )اذﻛﺮ ‪(........................................‬‬ ‫ﺑﯿﺎﻧﺎت ﺧﺎﺻﺔ ﺑﺎﻟﺘﻘﺮﯾﺮ وﻣﻘﺪم اﻟﺒﻼغ‬

‫‪ a‬اﻟﺘﺨﺪﯾﺮ‬ ‫‪ b‬اﻟﺪم – وﻣﺸﺘﻘﺎت اﻟﺪم‬ ‫‪ c‬أﺟﮭﺰة ‪/‬ﻣﻌﺪات ﻃﺒﯿﺔ أو ﺟﺮاﺣﯿﺔ‬ ‫‪ d‬ﺳﻘﻮط اﻟﻤﺮﯾﺾ‬ ‫‪ e‬ﺣﺪوث ﻋﺪوى ﻓﻲ ﻓﺘﺮة اﻟﺮﻋﺎﯾﺔ‬

‫‪  .٩‬ﻻ أرﻏﺐ‬

‫‪ .٨‬ﺗﺎرﯾﺦ اﻟﺘﻘﺮﯾﺮ‪______ __/__ ____/ ______ :‬‬ ‫ﯾﻮم‬

‫ﺳﻨﺔ‬

‫ﺷﮭﺮ‬

‫__________________‬ ‫_______________‬ ‫‪ .١٠‬اﺳﻢ ﻣﻘﺪم اﻟﺒﻼغ‪_______________ :‬‬ ‫اﻟﻠﻘﺐ‬ ‫اﺳﻢ اﻷب‬ ‫اﻻﺳﻢ‬ ‫‪ .١٢‬اﻟﺒﺮﯾﺪ اﻹﻟﻜﺘﺮوﻧﻲ‪______________________ :‬‬ ‫‪ .١١‬رﻗﻢ اﻟﺠﻮال‪___________________:‬‬ ‫‪ .١٣‬وﻇﯿﻔﺔ ﻣﻘﺪم اﻟﺒﻼغ‪______________________________________________________:‬‬ ‫ﺑﯿﺎﻧﺎت اﻟﻤﺮﯾﺾ )ﺗﻌﺒﺊ ﻓﻘﻂ إذا ﻛﺎﻧﺖ "ﺣﺎدﺛﺔ"(‬ ‫‪ .١٤‬ﻛﻢ ﻋﺪد اﻟﻤﺮﺿﻰ اﻟﻤﺘﻀﺮرﯾﻦ ﻣﻦ ﺣﺪوث اﻟﻮاﻗﻌﺔ؟‬

‫_________________‬ ‫اﻛﺘﺐ اﻟﺮﻗﻢ‬

‫‪ .١٥‬اﺳﻢ اﻟﻤﺮﯾﺾ‪_____________ :‬‬

‫_____________‬ ‫اﻷب‬

‫اﻻﺳﻢ‬

‫_________________‬ ‫اﻟﻠﻘﺐ‬

‫‪ .١٧‬اﻟﻤﻠﻒ اﻟﻄﺒﻲ‪___________________ :#‬‬ ‫اﻛﺘﺐ اﻟﺮﻗﻢ‬

‫‪ .١٦‬ﺗﺎرﯾﺦ ﻣﯿﻼد اﻟﻤﺮﯾﺾ‪______ __/__ ____/ _______ :‬‬ ‫ﺳﻨﺔ‬ ‫ﺷﮭﺮ‬ ‫ﯾﻮم‬ ‫ب‪ .‬أﻧﺜﻰ‬ ‫أ‪  .‬ذﻛﺮ‬ ‫‪ .١٨‬ﻧﻮع اﻟﻤﺮﯾﺾ‪:‬‬ ‫إذا ﺷﻤﻠﺖ اﻟﻮاﻗﻌﺔ أﻛﺜﺮ ﻣﻦ ﻣﺮﯾﺾ واﺣﺪ ‪ :‬ﻣﻦ ﻓﻀﻠﻚ اﺣﺮص ﻋﻠﻰ ﺗﻌﺒﺌﺔ ﻧﻤﻮذج ﻣﻌﻠﻮﻣﺎت اﻟﻤﺮﯾﺾ )‪ (PIF‬ﻟﻜﻞ ﻣﺮﯾﺾ‬ ‫ﺑﯿﺎﻧﺎت اﻟﺨﺎﻧﺎت اﻟﻤﻈﻠﻠﺔ ﻻﺳﺘﺨﺪام اﻟﻤﻨﺸﺄة اﻟﺼﺤﯿﺔ ﻓﻘﻂ وﻻ ﯾﺘﻢ إرﺳﺎﻟﮭﺎ ﺧﺎرﺟﮭﺎ‬ ‫رﻣﺰ اﻟﻮﺛﯿﻘﺔ‪306-FO-011-01 :‬‬

‫رﻗﻢ اﻹﺻﺪار‪٨ :‬‬

‫ﺗﺎرﯾﺦ اﻹﺻﺪار‪١٤٣٢/٠٨/٠١:‬‬

‫ﺗﺎرﯾﺦ اﻟﺘﻔﻌﯿﻞ‪ ١٤٣٢/١٠/٠١ :‬ﺗﺎرﯾﺦ اﻟﻤﺮاﺟﻌﺔ‪١٤٣٤/٠٨/٠١ :‬‬

‫رﻗﻢ اﻟﺼﻔﺤﺔ‪١ / ١ :‬‬



Ministry of Health



‫اﻟﻤﺪﯾﺮﯾﺔ اﻟﻌﺎﻣﺔ ﻟﻠﺸﺆون اﻟﺼﺤﯿﺔ‬ ‫ﺑﻤﻨﻄﻘﺔ ﻣﻜﺔ اﻟﻤﻜﺮﻣﺔ‬

PATIENT INFORMATION FORM (PIF) Confidential (No Duplication or Photocopy is Allowed and Not A Part of The Medical or Staff file) Not A Legal Document, Used ONLY For Study And Quality Improvement Purposes Event ID #; Initial Report Date (HERF Q8): DD MM YY

Use this form only if you are reporting an incident. (When reporting a perinatal incident that affected a mother and a neonate, complete a PIF for the mother and a separate PIF for the neonate.) Highlighted fields are collected for local facility and PSO use. This information will not be forwarded to the Network of Patient Safety Databases (NPSD). 1. At the time of the event what was the patient’s age? CHECK ONE: a.  Neonate (0-28 days) f.  Mature adult (65-74 years) b.  Infant (>28 days 2500 grams Anoxic or hypoxic encephalopathy Seizure(s) Infection (e.g., group B strep) Unexpected death Other: PLEASE SPECIFY

20. Which birth trauma? CHECK ONE:

a. b. c.

Subdural or cerebral hemorrhage Injury to brachial plexus Other: PLEASE SPECIFY

Thank you for completing these questions.

AHRQ Common Formats - Hospital Version 1.1 - March 2010 Release Page 3 of 3

Perinatal

Event ID: Initial Report Date (HERF Q 8 ):

Patient Safety Event Report:

PRESSURE ULCER Use this form to report a pressure ulcer or suspected Deep Tissue Injury that was 1) not present on admission (i.e., newlydeveloped), or 2) worsened during the patient’s stay. Report only an event that occurred prior to patient discharge. Narrative detail can be captured on the Healthcare Event Reporting Form (HERF). Highlighted fields are collected for local facility and PSO use. This information will not be forwarded to the Network of Patient Safety Databases (NPSD). Stage 1: Intact skin with non-blanchable redness of a localized area, usually over a bony prominence. Stage 2:

Partial-thickness tissue loss of dermis presenting as a shallow open ulcer with a red/pink wound bed, without slough.

Stage 3:

Full-thickness tissue loss. Subcutaneous fat may be visible but bone, tendon, or muscle are not exposed.

Stage 4:

Full-thickness tissue loss with exposed bone, tendon, or muscle.

Unstageable:

Full-thickness tissue loss in which the base of the ulcer is covered by slough and/or eschar in the wound bed.

Suspected Deep Tissue Injury:

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.

1. What was the most advanced stage of the pressure ulcer or suspected Deep Tissue Injury being reported? CHECK ONE:

a. b.

Stage 1 Stage 2

c.

Suspected Deep Tissue Injury

d. e. f. g. h.

Stage 3 Stage 4 Unstageable Mucosal ulcer only (no skin involvement) Unknown

STOP

This form is complete. GO TO QUESTION 2

GO TO QUESTION 3

STOP

This form is complete.

2. What was the status of the suspected Deep Tissue Injury on admission? CHECK ONE:

a.

Present as suspected Deep Tissue Injury

b. c. d.

Present as a Stage 1 pressure ulcer Not present Unknown

STOP

This form is complete. GO TO QUESTION 4

3. What was the status of the Stage 3, 4, or unstageable pressure ulcer on admission? CHECK ONE:

a. b. c. d. e. f. g.

Not present Stage 1 Stage 2 Suspected Deep Tissue Injury Stage 3 Stage 4 Unstageable

h.

Unknown

GO TO QUESTION 4

STOP



GO TO QUESTION 4 Pressure Ulcer






 4. On admission to this facility, was a skin inspection documented? CHECK ONE:

a. b. c.

Yes No Unknown

5. When was the first pressure ulcer risk assessment performed? CHECK ONE:

a. b.

c.

d. e.

On admission (within 24 hours) Not on admission, but done prior to the discovery of a newly-developed, or advancement of an existing, pressure ulcer Not on admission, but done after discovery of a newly-developed, or advancement of an existing, pressure ulcer No risk assessment performed Unknown

6. What type of risk assessment was performed? CHECK FIRST APPLICABLE:

a. b. c.

Formal assessment (e.g., Braden, Braden Q (pediatric version), Norton, Waterlow) Clinical assessment Unknown

7. As a result of the assessment, was the patient documented to be at increased risk for pressure ulcer? CHECK ONE:

a. b. c.

Yes No Unknown

8. Was any preventive intervention implemented? CHECK ONE:

a. b. c.

9. What intervention(s) was used? CHECK ALL THAT APPLY:

Yes No Unknown

a. b. c. d.

Pressure redistribution device Repositioning Nutritional support Other: PLEASE SPECIFY

10. Was the use of a device or appliance involved in the development or advancement of the pressure ulcer? CHECK ONE:

a. b. c.

Yes No Unknown

11. What was the type of device or appliance? CHECK ONE:

a. b. c. d. e. f.

Anti-embolic device Intraoperative positioning device Orthopedic appliance (e.g., cast, splint, orthotic) Oxygen delivery device (e.g., nasal prongs, oxygen mask) Tube Other: PLEASE SPECIFY

12. What was the type of tube? CHECK ONE:

a. b. c. d. e. f.


Endotracheal Gastrostomy Nasogastric Tracheostomy Indwelling urinary catheter Other: PLEASE SPECIFY

Pressure Ulcer



Event ID: Initial Report Date (HERF Q8 ):

13. During the patient’s stay at this facility, did the patient develop a secondary morbidity (e.g., osteomyelitis or sepsis)? CHECK ONE:

b. c.

No Unknown

ulcer or suspected Deep Tissue Injury? CHECK ONE:

a. b. c.

Yes No Unknown



Pressure Ulcer


Patient Safety Event Report:

SURGERY OR ANESTHESIA Use this form to report an event involving a surgical or other invasive procedure (e.g., colonoscopy), or the administration of anesthesia. Do not complete this form if the event involved the removal of organs from brain-dead patients (ASA Class 6) or handling an organ after procurement. If the event involved an anesthetic device, please also complete the Device or Medical/Surgical Supply form. If the event involved an anesthetic, medical gas, medication, or other substance, please also complete the Medication or Other Substance form. If the event involved a healthcare-associated infection, please also complete the Healthcare-associated Infection form. Narrative detail can be captured on the Healthcare Event Reporting Form (HERF). Highlighted fields are collected for local facility and PSO use. This information will not be forwarded to the Network of Patient Safety Databases (NPSD). 1. Describe briefly the procedure associated with this event:

2. Enter ICD-10-AM procedure code associated with this event: ICD-10-AM CODE

3. What was the patient’s documented American Society of Anesthesiologists (ASA) Physical Classification System class? CHECK ONE:

a. b. c.

Class 1 Class 2 Class 3

d. e. f.

Class 4 Class 5 ASA classification was not documented

4. Was the procedure performed as an emergency? CHECK ONE:

a. b. c.

Yes No Unknown

5. When was the event discovered? CHECK ONE:

a. b. c. d. e. f. g. h. i. j.

Before anesthesia started (or no anesthesia used) After anesthesia started, but before incision or start of procedure After procedure started (incision) but before procedure ended (closure) At closure, if surgical operation After procedure ended, but before patient left operating room or other procedure area During post-anesthesia care/recovery period After post-anesthesia recovery, but before discharge After patient was discharged During anesthesia when no surgical operation or invasive procedure was performed Unknown

6. What was the total length of the procedure (i.e., induction of anesthesia to the end of anesthesia)? CHECK ONE:

a. b. c. d. e.


Less than 1 hour Greater than or equal to 1 hour, but less than 3 hours Greater than or equal to 3 hours, but less than 5 hours Greater than or equal to 5 hours Unknown

Surgery or Anesthesia


7. What type of anesthesia or sedation was used?

a. b. c. d.

CHECK FIRST APPLICABLE:

General anesthesia Regional anesthesia (e.g., epidural, spinal, or peripheral nerve blocks) Local or topical anesthesia Sedation only

8. What was the level of sedation? CHECK ONE:

a. b. c. d. e.

e.

Deep sedation or analgesia Moderate sedation or analgesia (conscious sedation) Minimal sedation (anxiolysis) No sedation (if regional, local, or topical anesthesia) Unknown ANSWER QUESTION 11

None

9. Who administered (or, if the event occurred prior to administration of anesthesia, person who was scheduled to administer) the anesthesia? CHECK ONE:

a.

Anesthesiologist

c. d.

Other healthcare professional Unknown

CHECK ONE:

a. b. c.

Yes No Unknown

11. What was the medical or surgical specialty of the provider who performed the procedure? CHECK ONE: SELECT THE SPECIALTY OF THE PROVIDER OR TEAM THAT PERFORMED THE PROCEDURE. IF THE PROCEDURE WAS NOT STARTED, SELECT THE SPECIALTY OF THE PROVIDER WHO WAS SCHEDULED TO PERFORM THE PROCEDURE.

a. b. c. d. e. f. g. h. i. j. k. l. m.

Anesthesiology Cardiology Colorectal surgery Dentistry, including oral surgery Dermatology Emergency medicine Family medicine Gastroenterology General surgery Internal medicine Neurological surgery Obstetrics/Gynecology Ophthalmology


n. o. p. q. r. s. t. u. v. w. x. y.

Orthopedic surgery Otolaryngology Pediatrics Pediatric surgery Plastic surgery Podiatry Pulmonology Radiology, including vascular and interventional Thoracic surgery Urology Vascular surgery Other: PLEASE SPECIFY



12. What best describes the event? CHECK ONE:

a.

Surgical event

ANSWER QUESTION 15

b.

Anesthesia event

ANSWER QUESTION 24

c.

Major complication that could be associated with either surgery or anesthesia

ANSWER QUESTION 13

13. Which of the following major complications occurred? CHECK ONE:

a. b. c. d.

e.

Cardiac or circulatory event Central nervous system event Renal failure, impairment, or insufficiency Respiratory failure, requiring unplanned respiratory support, within 24 hours after the procedure Other: PLEASE SPECIFY

14. Which of the following best describes the respiratory support provided? CHECK ONE:

a. b.

Prolonged ventilator support Re-institution of ventilator following discontinuation Other: PLEASE SPECIFY

c.

IF MAJOR COMPLICATION

STOP


15. Was the surgical event an unintentionally retained object? CHECK ONE:

a. b.

Yes No

ANSWER QUESTION 21

16. What type of object was retained? CHECK ONE:

a. b. c. d. e. f.

Sponge Needle Towel Whole instrument (e.g., clamp) Instrument fragment Other: PLEASE SPECIFY




17. Was a count performed for the type of object that was retained? CHECK ONE:

a.

b. c. d.

18. After counting, what was the reported count status? CHECK ONE:

Yes

No, object “countable” No, object not “countable” (e.g., broken piece retained) Unknown

a.

Incorrect (unreconciled) count

b.

Correct (reconciled) count

STOP

ANSWER QUESTION 19

STOP



19. Was an x-ray obtained before the end of the procedure to detect the retained object? CHECK ONE:

a. b. c.

Yes No Unknown

20. Was the retained object radiopaque (i.e., detectable by x-ray)? CHECK ONE:

a. b. c.

Yes No Unknown

STOP

IF RETAINED OBJECT


21. Which of the following best characterizes the surgical event? CHECK ONE:

a. b.

Surgical site infection Bleeding requiring return to the operating room

c.

Burn and/or operating room fire

ALSO COMPLETE THE HEALTHCARE-ASSOCIATED INFECTION FORM

22. Which of the following occurred?

a. b. c. d. e. f. g. h. i. j. k.

Incorrect surgical or invasive procedure Iatrogenic pneumothorax Unintended laceration or puncture Dehiscence, flap or wound failure or disruption, or graft failure Unintended blockage, obstruction, or ligation Unplanned removal of organ Air embolus Other: PLEASE SPECIFY

CHECK ONE:

Burn Operating room fire Both

23. What was incorrect about the surgical or invasive procedure? CHECK FIRST APPLICABLE:

a. b. c. d. e. f. g.

Incorrect patient Incorrect side Incorrect site Incorrect procedure Incorrect implant by mistake Incorrect implant because correct implant was not available Other: PLEASE SPECIFY

IF SURGICAL EVENT


STOP




24. If the event involved anesthesia, which of the following best characterizes the event? CHECK ONE:

a. b. c. d. e. f.

Dental injury Ocular injury Peripheral nerve injury Awareness (during anesthesia) Malignant hyperthermia Problem with anesthetic, medical gas, medication, or other substance

g.

Problem with device used in the delivery of anesthesia

h.

Difficulty managing airway

i.

Other: PLEASE SPECIFY

ALSO COMPLETE THE MEDICATION OR OTHER SUBSTANCE FORM ALSO COMPLETE THE DEVICE OR MEDICAL/SURGICAL SUPPLY FORM

25. Which of the following best characterizes the airway management problem? CHECK ONE:

a. b. c. d. e.

Difficulty during tracheal intubation Difficulty maintaining airway during procedure Esophageal intubation Re-intubation, following extubation, in the operating or recovery room Other: PLEASE SPECIFY


.





Ministry of Health





ANNEX 4: EVENTS CATEGORIES DESCRIPTIONS

ANNEX 4: EVENTS CATEGORIES DESCRIPTIONS


 





The electronic document on the hospital intranet is the controlled document according to document control policy. Any kind of electronic/manual document is the responsibility of its be-holder for its contents and up-date.

Healthcare Event Reporting Form (HERF), Patient Information Form (PIF) and Summary of Initial Report (SIR) Event Description 1.0 Type of Event 1.1 A patient safety concern is reported as one of the following types 1.1.1 Incident 1.1.1.1 Harm 1.1.1.2 No harm 1.1.2 Near miss (close call) 1.1.3 Unsafe condition 1.2 A patient safety concern is identified as one or more of the following categories 1.2.1 Blood or Blood Product 1.2.2 Device or Medical/Surgical Supply 1.2.3 Fall 1.2.4 Healthcare-associated Infection 1.2.5 Medication or Other Substance 1.2.6 Perinatal 1.2.7 Pressure Ulcer 1.2.8 Surgery or Anesthesia 1.2.9 Other 1.3 An event meeting Sentinel (Serious Reportable) Event definition as one of the following: Surgical Events 1.3.1 Surgery performed on the wrong body part 1.3.2 Surgery performed on the wrong patient 1.3.3 Wrong surgical procedure performed on a patient 1.3.4 Unintended retention of a foreign object in a patient after surgery or other procedure 1.3.5 Intraoperative or immediately postoperative death in an ASA Class I patient Product or Device Events 1.3.6 Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility 1.3.7 Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended 1.3.8 Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility Patient Protection Events 1.3.9 Infant discharged to the wrong person 1.3.10 Patient death or serious disability associated with patient elopement (disappearance) 1.3.11 Patient suicide, or attempted suicide, resulting in serious disability while being cared for in a healthcare facility Care Management Events 1.3.12 Patient death or serious disability associated with delay of care provision (e.g., delay in the access to care, assessment/re-assessment, interventions.etc.) 1.3.13 Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration) 1.3.14 Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products 1.3.15 Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare facility

Code306-CG-PP011-001 Issue No :1 Issue Date 01/08/1432H Activation Date: 01/10/1432H Revision Date: 01/08/1432H Page No:1 / 5

 






Healthcare Event Reporting Form (HERF), Patient Information Form (PIF) and Summary of Initial Report (SIR) Event Description 1.3.16 1.3.17 1.3.18 1.3.19 1.3.20

Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility Patient death or serious disability due to spinal manipulative therapy Artificial insemination with the wrong donor sperm or wrong egg

Environmental Events 1.3.21 Patient death or serious disability associated with an electric shock while being cared for in a healthcare facility 1.3.22 Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances 1.3.23 Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility 1.3.24 Patient death or serious disability associated with a fall while being cared for in a healthcare facility 1.3.25 Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility Criminal Events 1.3.26 Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider 1.3.27 Abduction of a patient of any age 1.3.28 Sexual assault on a patient within or on the grounds of a healthcare facility 1.3.29 Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare facility. 2.0 Circumstances of Event 2.1 Date and time of event 2.1.1 Date the event was discovered 2.1.2 Time the event was discovered 2.2 Where event occurred or unsafe condition exists 2.2.1 Inpatient general care area (e.g., medical/surgical unit) 2.2.2 Special care area (e.g., ICU, CCU, NICU) 2.2.3 Labor and delivery 2.2.4 Operating room or procedure area (e.g., cardiac catheter lab, endoscopy area), including PACU or recovery area 2.2.5 Radiology/imaging department, including onsite mobile units 2.2.6 Pharmacy 2.2.7 Laboratory, including pathology department and blood bank 2.2.8 Emergency department 2.2.9 Other area within the facility 2.2.10 Outpatient care area 2.2.11 Outside area (i.e., grounds of the facility) 2.3 Factors contributing to the event known at the time of summary of initial report Environment 2.3.1 Culture of safety, management 2.3.2 Physical surroundings (e.g., lighting, noise)


 






Healthcare Event Reporting Form (HERF), Patient Information Form (PIF) and Summary of Initial Report (SIR) Event Description

2.4 2.5 2.6

2.7

2.8

Staff qualifications 2.3.3 Competence (e.g., qualifications, experience) 2.3.4 Training Supervision/support 2.3.5 Clinical supervision 2.3.6 Managerial supervision Policies and procedures, includes clinical protocols 2.3.7 Presence of policies 2.3.8 Clarity of policies Equipment/device 2.3.9 Function 2.3.10 Design 2.3.11 Availability 2.3.12 Maintenance Data 2.3.13 Availability 2.3.14 Accuracy 2.3.15 Legibility Communication 2.3.16 Supervisor to staff 2.3.17 Among staff or team members 2.3.18 Staff to patient (or family) Human factors 2.3.19 Fatigue 2.3.20 Stress 2.3.21 Inattention 2.3.22 Cognitive factors 2.3.23 Health issues Association of event with health information technology (HIT) Association of a handover/handoff with event Preventability of incident 2.6.1 Almost certainly could have been prevented 2.6.2 Likely could have been prevented 2.6.3 Likely could not have been prevented 2.6.4 Almost certainly could not have been prevented 2.6.5 Provider does not make this determination by policy Reason near miss did not reach patient 2.7.1 Fail-safe designed into the process and/or a safeguard worked effectively 2.7.2 Practitioner or staff who made the error noticed and recovered from the error (avoiding any possibility of it reaching the patient) 2.7.3 Spontaneous action by a practitioner or staff member (other than person making the error) prevented the event from reaching the patient 2.7.4 Action by the patient or patient’s family member prevented the event from reaching the patient Narrative descriptions 2.8.1 Description of patient safety event or unsafe condition by initial reporter 2.8.2 Summary of initial findings regarding patient safety event or unsafe condition by patient safety staff. 2.8.3 Reporter’s job or position 2.8.4 Location where event occurred or unsafe condition exists.


 






Healthcare Event Reporting Form (HERF), Patient Information Form (PIF) and Summary of Initial Report (SIR) Event Description 3.0 Patient Information 3.1 Identifying information about patient affected 3.1.1 Name 3.1.2 Date of birth 3.1.3 Medical record number 3.1.4 Age range 3.1.4.1 Neonate (0-28 days) 3.1.4.2 Infant (>28 days