Ministry of Health s2

Ministry of Health

Department of Quality

Directorate General of Health Planning

SENTINEL EVENTS NATIONAL OBSERVATORY

Sentinel Events Monitoring Protocol

July 2009

This present version is approved by the Regions and by the Autonomous Provinces and substitutes all previous editions. INDEX

1. INTRODUCTION...... 3 2. OBJECTIVES...... 4 3. CRITERIA FOR THE DEFINITION OF SENTINEL EVENT...... 4

3.1 LIST OF SENTINEL EVENTS...... 5 3.2 SEVERE HARM...... 5 4. PROCEDURE FOR THE SIGNALLING AND TRANSMISSION OF SENTINEL EVENTS....6

4.1 METHOD FOR SENDING PAPER FORMS...... 7 DESCRIPTIVE FORMS OF SENTINEL EVENTS...... 9 FORM A...... 26 FORM B...... 32 GLOSSARY...... 42 1. INTRODUCTION

Adverse events are unexpected events related to the care process which result in an unintentional and undesirable injury to the patient. The reporting systems of these events are an essential tool to increase awareness of the causes and contributing factors according to the "principle of learning from error." In this context, the monitoring of sentinel events is a major action for public health and aims to collect information on severe and potentially avoidable adverse events, which can lead to death or serious harm to the patient and determines a loss of public confidence towards the National Health Service (NHS). Due to the severity of such events, a single occurrence is sufficient for the organization to consider opportune: a) an immediate investigation to ascertain what factors have caused/ contributed to the event can be eliminated, b) identifying and implementing appropriate corrective measures. The National Health Plan 2006 - 2008 places emphasis on the promotion of policies regarding clinical governance, patient safety and in particular foresees that "... monitoring activities must be conducted in accordance with methods of graduated criteria of severity of events, providing that the three levels, national, regional and health trust promote their activities, according to a coherent and workable manner. A monitoring of sentinel events must be activated ... ". The Ministry of Health in 2005 has enabled the monitoring of sentinel events with the aim of sharing with the Regions and Autonomous Provinces (PA) and health care trusts a unique way for monitoring and management of sentinel events on the national territory to guarantee essential levels of assistance (LEA). The monitoring of sentinel events includes, the collection and analysis of information; the production and subsequent implementation of specific recommendations to prevent or minimize the risk of occurrence of these particular adverse events, and as well as the return of information to healthcare facilities of the NHS thus enhancing a patient safety culture. During the first 4 years of activity 385 reports have been collected and there has been an emergence for the need to improve the adherence to the use of guidelines, Recommendations and procedures for preventing errors in care practices, promote training concerning clinical risk, improve communication processes between operators and between operators and patients.

The Understanding of the " Conferenza Permanente Rapporti Stato Regioni” of March 20, 2008 concerning the clinical risk management and patient safety and care foreseen by the Ministry, the activation of the National Observatory on sentinel events through the Information System for Monitoring of Errors in Health (SIMES). This system will be operational following the ministerial decree envisaged as stated above. This version of the Monitoring Protocol is the pattern established by the application of NSIS - SIMES, with the modifications that were necessary due to the collection and analysis of data received, characteristics of confidentiality and anonymity in relation to health facilities and professionals were maintained. 2. OBJECTIVES

The Ministry of Health intends to increase patient safety in healthcare structures and ensuring LEAs through the following actions:

At the central level  Collection and analysis of reports regarding sentinel events  Elaboration and dissemination of the Recommendations specific aimed at all healthcare facilities  Evaluation of the implementation of the recommendation carried out by the healthcare facilities  Information returned to healthcare structures

At the local level  Collection of the reports regarding sentinel events  Analysis of the cause and contributing and determining factors for the occurrence of these events  Identification and implementation of preventative actions  Verification of the effectiveness of the implementation of preventive measures

3. CRITERIA FOR THE DEFINITION OF SENTINEL EVENT

The definition and the type of sentinel event are functional to the objectives and the needs/ requirements by the adopting organization. In the context of the monitoring protocol of sentinel events, the Ministry defines sentinel events as “ a serious adverse event, potentially avoidable that can cause death, serious harm to the patient and loss of faith in the NHS by the citizens. A single occurrence of an adverse event can give way to a direct cognitive survey/investigation to ascertain to that avoidable or reducible contributed thus activating the appropriate corrective measures. The following is a list of sentinel events that are recognized and reported to the Ministry. 3.1 List of Sentinel Events

1. Procedure performed on wrong patient 2. Procedure performed on wrong body part (side, organ or part) 3. Wrong procedure performed on correct patient 4. Retention of instruments or other foreign object during surgery requiring another or successive surgery or procedure performed to rectify error 5. Transfusion reaction consequent to AB0 incompatibility 6. Death, coma or severe functional alterations derived from error in pharmacological therapy 7. Maternal death or illness correlated to labour and/or childbirth 8. Death or permanent disability in healthy newborn weighing > 2500 grams not correlated to a congenital illness 9. Death or severe injury due to patient fall 10. Patient suicide or attempted suicide in a hospital 11. Violent acts to hospitalized patient 12. Acts of violence sustained by healthcare workers 13. Death or severe harm consequent to a malfunction of the transport system (intrahospital, extrahospital) 14. Death or severe injury due to an incorrect attribution of a triage code by the Central Operative unit 118 and/or in the Emergency Ward/ First Aid 15. Unexpected Death and/or Severe Harm Consequent to a Surgical Procedure 16. Every other adverse event that causes death or severe injury

3.2 Severe Harm With reference e to the definition of an sentinel event, of which point 3.1 “ … an adverse event particularly severe, potentially avoidable, that can cause death or severe harm…” and as far as this the monitoring protocol is concerned, a severe injury is considered to be an unintentional and undesirable consequence deriving from adverse events.

Therefore, sentinel events are events that determine outcomes or clinical conditions that bring about changes in the patient’s care pathway, as indicated below:  Death  Permanent disability  Coma  State of health that determines prolonged hospital stay or worsening of condition  Further trauma consequent to patient fall  Transfer to a semi-intensive unit or intensive care unit.  Successive surgery  Cardiopulmonary resuscitation  Request for specific psychiatric and psychological treatments as a consequence to attempted suicide or violence sustained within structure  Transfusion reaction consequent to AB0 incompatibility (independent of the severity of injury)  Other o If “other” specify (for example, therapeutic treatments with additional pharmaceuticals that wouldn’t have been otherwise necessary, request for complex diagnostic tests, trauma and fractures not caused by falls).

4. PROCEDURE FOR THE SIGNALLING AND TRANSMISSION OF SENTINEL EVENTS

Each time an adverse events occurs, the health trust management, must not only take on the patient in order to activate all the necessary measures in order to mitigate the harm caused and activate the required communication processes with the patient and their family members in a transparent and complete manner, but must also place in act the following actions, to the reporting protocol of sentinel events. 1. the healthcare worker (physician, nurse or other healthcare professional involved in the adverse event or came to the knowledge of the occurrence of an adverse event must communicate what happened to the clinical risk reference person (function/unit) or to the trust management (health/ general management), according to the procedures indicated at the regional or health trust level. 2. The reference person responsible for clinical risk management, where present, or other representative indicated by the Health trust management:

 Must immediately launch an internal investigation to determine whether the adverse event meets the criteria to qualify as a sentinel event;  If the internal investigation showed that the adverse event is due to error (active or latent) and that it may have caused harm/injury as indicated in section 3.2, report the sentinel events using form A of this Protocol;  collect and analyze all necessary information to understand the factors and causes that have contributed and given rise to the occurrence of the event, following the instructions contained in Form B of this Protocol;  return Form B within 45 days for the analysis of the causes, contributing factors and the action plan.

4.1 Method for sending paper forms Health facilities send Form A (the initial report form) and Form B (form for the analysis of the causes, contributing factors and action plan), which are integral parts of the Monitoring Protocol to the Ministry as follows:

Send Form A The contact person for the management of clinical risk, where available, or a contact person identified by management, fills out a form, sends it to the Ministry, also through their region, at the time of the event or to the knowledge of it.

Send Form B The contact person for the management of clinical risk, where available, or a contact person identified by management fills out form B, sends it to the Ministry, also through their region, within 45 calendar days. As part of the progressive activation of the Monitoring Protocol of sentinel events through the application of NSIS - SIMES, reports of sentinel events and their validation at different levels of government (Local, Regional and PA, Ministry) may be in the manner identified by each Region using the SIMES application, after proper registration, or by sending periodic workflow. The link http://www.nsis.salute.gov.it/ is the only port of access for users who must insert and validate the sentinel events subject to reporting.

Sending sentinel events via mail, fax and postal mail is foreseen for a temporary period.

Send Forms A and B via: - e-mail: [email protected] - fax: 06 59942074 - ordinary post to the following address: Ministero della Salute Direzione Generale della Programmazione Sanitaria, dei livelli di assistenza e dei principi etici di sistema Ufficio III Via Giorgio Ribotta, 5 00144 Roma

For further enquiries contact:

Dr. Alessandro Ghirardini Tel: 06-5994-2261 e-mail: [email protected] Dr. Rosetta Cardone Tel: 06-5994-2932 e-mail: [email protected] Dr. Susanna Ciampalini Tel 06-5994-2418 e-mail: [email protected] Dr. Giorgio Leomporra Tel: 06-5994-2996 e-mail: [email protected] Ministry of Health

Department of Quality Directorate General of Health Planning

SENTINEL EVENTS NATIONAL OBSERVATORY

DESCRIPTIVE FORMS OF SENTINEL EVENTS Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 1

Procedure Performed on Wrong Patient

Description:

Performing surgical or invasive procedures on a patient other than the one needing surgery. Includes all surgical interventions or invasive procedures (e.g. interventional radiology), performed in emergency, outpatient and inpatient requiring hospitalization/ admission (ordinary and day surgery) and outpatient, regardless of the complexity of health services. Excludes non-surgical procedures.

Rationale The event highlights the possible organizational shortcomings, such as the lack or inadequate implementation of specific procedures and/or insufficient communication between operators or between operators and patients/families. In particular, the event may be due to compilation error, transfer and/or exchange of clinical documentation, the improper application of information to the patient assisted person and their family members. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, operative records and any other useful documentation or source.

Note Recommendation No. 3 for the correct patient identification, surgical site and procedure is available on the Ministry website. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 2

Procedure Performed on Wrong Body Part (side, organ or part)

Description Performing a surgical procedure on the correct patient, but on the wrong side, organ or body part. Includes all surgical procedures performed in emergency, requiring hospitalization (ordinary and day surgery) and outpatient, regardless of the complexity of the health service.

Rationale The event highlights the possible organizational shortcomings, such as the lack or inadequate implementation of specific procedures and / or insufficient communication between operators or between operators and patients / families. In particular, the event may be due to compilation error, transfer and / or exchange of clinical documentation, the improper application of information to the patient and their family members. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, operative records and any other useful documentation or source.

Sentinel Event No. 3

Wrong Procedure performed on correct patient

Description

Performing a diagnostic procedure/therapy other than that prescribed.

Rationale The event highlights the possible organizational shortcomings, such as the lack or inadequate implementation of specific procedures and / or insufficient communication between operators or between operators and patients / families. In particular, the event may be due to compilation error, transfer and / or exchange of clinical documentation, the improper application of information to the patient person and their family members. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, operative records and any other useful documentation or source.

Sentinel Event No. 4

Retention of instruments or other foreign objects during surgery requiring another or successive surgery or procedure performed to rectify error

Description Instrument or other material left within the surgical site during a surgery that requires a subsequent intervention. Covers all surgical instruments, gauze, suture needles, instrumentation items including screws, pieces of needles deriving from local anaesthesia, surgical drainage of debris and other material connected with the execution of surgery, but not intentionally left in the surgical site.

Rationale The event highlights the possible organizational shortcomings, such as the lack or inadequate implementation of specific procedures and / or insufficient communication between operators or between operators and patients/families. In particular, the event may be due to lack of or inadequate implementation of procedures for counting surgical instruments or other material. . The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, operative records and any other useful documentation or source.

Note: Recommendation No. 2 for the prevention of retention of instruments or other foreign objects during surgery is available on the Ministry website. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 5

Transfusion Reaction consequent to AB0 incompatibility

Description Transfusion reactions caused by AB0 incompatibility. Included are all transfusion reactions by AB0 incompatibility, regardless of the severity of the damage.

Rationale The event highlights possible shortcomings in the organizational management of different stages of the transfusion process from sample for blood group typing of the recipient, to the transfusion of blood components and / or inadequate communication between operators or between operators and patients / family. In particular, the event may be due to incorrect compilation, transfer and exchange of clinical documentation, difficulty in understanding the request, exchange of tubes or blood bags, inattention by health professionals. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, laboratory records and all other valuable documentation or source

Note Recommendation No. 5 on the prevention of transfusion reactions consequent to AB0 incompatibility is available on the Ministry website.

Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 6

Death, Coma or Severe Harm Caused by Errors in Pharmacological Therapy

Description Death, coma, physiological alterations and any other serious damage resulting from errors during the course of drug treatment in medical facilities. Anaphylactic shock in a patient with a known history of allergy to the drug that was administered and which caused the reaction. Exclusions: Adverse drug reactions, side effects or other effects not determined by errors.

Rationale The event highlights the possible organizational shortcomings such as the lack or inadequate implementation of specific procedures and/or insufficient communication between operators or between operators and patients/families, as well as improper training. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation and any other valuable documentation or source.

Note Recommendation No. 7 for the prevention of death, coma or severe damage resulting from errors in medication is available on the Ministry website. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 7

Maternal Death or Severe Illness related to Labour and/or Childbirth

Description Maternal death or serious illness related to labour (spontaneous or induced) and / or childbirth and puerperium

Rationale The event highlights potential organizational deficiencies, such as the lack of care procedures, the underestimation of risk factors, insufficient communication amongst operators and amongst operators and patients/families. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, including certificate of service delivery, documentation of the course of pregnancy and any other documentation or source valuable.

Note Recommendation No. 6 for the prevention of maternal death or serious illness related to labour and/or childbirth is available on the Ministry website. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 8

Death or Permanent Disability in healthy newborns weighing > 2500 grams, not related to congenital illness

Description Death or serious medical condition, which may result in permanent disability, in healthy babies weighing > 2500 grams, not suffering from congenital diseases or other pathologies incompatible with life.

Rationale The event highlights potential organizational deficiencies, such as the lack of care procedures, the underestimation of risk factors, insufficient communication amoung operators and amoung operators and patients/families. In particular, the event may be due to therapeutic delays / omissions care during childbirth or peri natal life. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Medical records regarding the mother and baby, including the birth assistance certificate and any other valuable documentation or source. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 9

Death or Severe Injury due to Patient Fall

Description Death or serious injury caused by patient fall in health facilities. This list includes only falls that cause death or serious injury.

Rationale The event highlights the possible organizational shortcomings, such as the lack or inadequate implementation of specific procedures and/or insufficient communication between operators or amoung operators and patients/families. In particular, the event may be due to underestimation of the risk factors related to patients (e.g. age, previous falls, taking certain medications, cognitive deficits, associated disorders, footwear, inadequate clothing) or risk factors related to the environment (e.g. slippery floors, unsafe stairwells, lack of lighting, lack of support points). The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation and any other useful documentation or source on this subject, including, if possible, the description of the incident reported by the patient. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 10

Patient Suicide or Attempted Suicide in a Hospital

Description Death by suicide or attempted suicide within a healthcare facility, including also Mental Health Outpatient Services.

Rationale The event highlights the possible organizational shortcomings, such as the lack or inadequate implementation of specific procedures and/or insufficient communication amoung operators or amoung operators and patients/families. In particular, the event may be due to the lack of appropriate procedures to take charge of the patient, the underestimation of the mental state of the patient, inadequate supervision of patients at risk, a non-compliant suitable environment. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation and any other valuable documentation or source.

Note Recommendation No. 4 for the prevention of patient suicide or attempted suicide in hospital is available on the Ministry website. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 11

Violent Acts to Hospitalized Patient

Description Any type of violence (on account or omission) to patient committed by anyone (healthcare professional, another patient, family, visitor) in health care facilities.

Rationale The event highlights the possible organizational shortcomings such as the lack or inadequate implementation of specific procedures and/or insufficient communication amoung operators or amoung operators and patients/families and may indicate a lack of awareness of the organization of the possible dangers of aggression within healthcare facilities. In particular, the event may be due to lack of vigilance, possible stress and burn-out of personnel, and lack of information and training. The recognition of the event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, including complaints presented to URP, and any other valuable documentation or source. Ministry of Health

Department of Quality Directorate General of Health Planning

Sentinel Event No. 12

Acts of Violence Sustained by Healthcare Workers

Description Violence acts against healthcare worker in healthcare facilities committed by: patients, their relatives or caregivers, and visitors.

Rationale The event highlights the possible organizational weaknesses and may indicate insufficient awareness of the organization of the possible danger of violence in healthcare facilities. In particular, the event may be due to lack of vigilance, underestimation of patients at risk of making physical attacks, relationship difficulties between operators and users. The recognition of the event is important to proceed with the definition of interventions in organizational and logistical support, for the revision of the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation and any other useful source for the collection of information, including complaints filed with the Members of the public security offices and INAIL records.

Note Recommendation No. 8 for the prevention of acts of violence against Healthcare worker is available on the Ministry website. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 13 Death or severe harm consequent to a malfunction of the transport system (intrahospital, extrahospital)

Description Patient death or serious injury resulting from failure of the inpatient-or outpatient, (intrahospital or extrahospital)transport system, both of the emergency-urgent care 118 and scheduled appointments. All transport system malfunctions/ failures are included, intra-hospital and outpatient, whether land, air or sea, involving adults or paediatric- neonatal patients, resulting in death or serious harm to the patient because of the occurrence of one or more of the following situations : failure or untimely arrival to location by means of assistance, expedition of inappropriate form of transport in relation to the emergency involved or in relation to geographical area or in relation to local weather conditions, interruption or delay in transportation due to sudden mechanical failure, sending an inappropriate means of transport lacking appropriate medications/pharmaceuticals, medical devices and / or specific emergency treatment devices, or presence of unskilled or unfit medical personnel for the kind of emergency involved.

Rationale The occurrence of the event indicates a lack of organization or logistics of the transport system which may concern or involve the training of personnel, agreement and effort of health professionals involved in assessment protocols and transfer of patients, the operational coordination and pre-transport system communication, periodic maintenance of vehicles both in terms of mechanical efficiency as well as kits and devices for emergency treatment, the use of transport resources under safety conditions. The recognition of the event is important in order to proceed with the definition of interventions in organizational and logistical support for the revision of the protocols in use, to start continuous education programs and personnel training.

Useful sources for the analysis of sentinel events Clinical documentation, emergency room reports, Central Operations 118, transport cards and any other useful documentation or source on this subject. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 14

Death or Severe Harm Consequent to an Incorrect Triage Code Application in the Central Operative Unit 118 and/or in First Aid

Description Patient death or serious injury resulting from incorrect assignment of the severity code following a triage code application at the event, on emergency vehicles, in the Operations Centre 118, and inside the emergency room of a hospital. Includes all patients who were assigned by staff members responsible for code application, an underestimated severity code compared to the actual clinical severity resulting in death or serious harm as a result of the failure or delay in medical intervention or sending the patient to an inappropriate diagnostic-therapeutic pathway. Exclusions: patients in whom the erroneous attribution of triage code does not affect the timeliness of medical intervention and does not produce adverse effects to the patient because the results of the underestimation in delayed timing and type of intervention is not relevant to the outcome.

Rationale The occurrence of the event indicates a malfunction of the triage system because of a lack of knowledge sharing and protocols by the staff involved or due to poor local adaptation of the protocols used at the facility or inadequate training and education of the assigned staff nurses. The recognition of the event is important to undertake an audit of triage protocols or to start continuous education programs and personnel training activities.

Useful sources for the analysis of sentinel events Clinical documentation, emergency room reports, Central Operational 118, triage cards, and any other valuable documentation or source. Ministry of Health Department of Quality Directorate General of Health Planning

Sentinel Event No. 15

Unexpected Death and/or Severe Harm Consequent to a Surgical Procedure

Description Unexpected death or serious injury resulting in surgery, regardless of the complexity of the intervention. Exclusions: all adverse events resulting from the patient’s clinical condition and attributed to the associated intrinsic risk.

Rationale The event highlights the possible organizational shortcomings such as lack or inadequate implementation of specific procedures and guidelines for safety in the surgical route, insufficient communication amoung operators or amoung operators and patients / families, inadequate personnel management, poor education and training, inadequate supervision of operators. The recognition of this event is important to proceed with the definition of interventions in terms of organization, to review the protocols in use, to start a training activity and training of personnel.

Useful sources for the analysis of sentinel events Clinical documentation, surgery records and any other valuable documentation or source. Ministry of Health

Department of Quality Directorate General of Health Planning

Sentinel Event No. 16

Every other adverse event that causes death or severe harm to the patient

Description All other adverse events due to errors and/or substandard care (assistance levels lower than the expected standards), not included in the 15 sentinel events as previously described which causes death or serious harm to the patient.

Rationale The occurrence of the event is indicative of possible organizational weaknesses, insufficient or inadequate training of operators, lack of communication amongst workers, factors that determine a loss of public confidence/trust towards the NHS. The recognition of this event is important to proceed with the definition of interventions in terms of organization and logistical support, for the revision of the protocols in use, to start a training activity and training of personnel.

Useful sources for the analysis of sentinel events Clinical documentation, operative records and any other valuable documentation or source. Ministry of Health

Department of Quality Directorate General of Health Planning

NATIONAL OBSERVATORY ON SENTINEL EVENTS

FORM A

Signalling of Sentinel Event

July 2009 Ministry of Health Department of Quality Directorate General of Health Planning

SIGNALLING OF SENTINEL EVENTS (1) *Name of Healthcare facility: ………………………………………………………………………………………… …………………………………………………………………………………………

ASL /A.O.: …………………………………………………………………………………………

Region: ……………………Province: …………Municipality: ………………...... Structure Type: ……………………………………………………………………….. …………….…………………………………………………………………………...

*Reference person for the compilation: …………………………………………… ...... ………………………………………………………………………….. Position: …………………………………………………………………………….. ………………………………………………………………………………………. Tel: ……………………fax: ……………………e-mail: …………………………. ……..………………………………………………………………………………... (fill out at least one amongst tel, fax e mail))

Date completed: ……./……./…………………..

*obligatory field (1) In the event where more than one sentinel event occur to the same patient, complete a form for each single event. LIST OF SENTINEL EVENTS * Indicate with an [X] the Sentinel Event which occurred: 1 Procedure performed on wrong patient

2 Surgical procedure performed on wrong body part (side,organ or part) 3 Wrong procedure performed on correct patient

4 Retention of instruments or other foreign object during surgery requiring another or successive surgery or procedure performed to rectify error 5 Transfusion reaction consequent to AB0 incompatibility

6 Death, coma or severe functional alterations derived from error in pharmacological therapy 7 Maternal death or severe illness correlated to labour and/or childbirth 8 Death or permanent disability in healthy newborn weighing > 2500 grams not correlated to a congenital illness 9 Death or severe injury due to patient fall

10 Patient suicide or attempted suicide in a hospital

11 Violence acts to hospitalized patient

12 Acts of violence sustained by healthcare workers

13 Death or severe harm consequent to a malfunctional transport system (intrahospital, extrahospital) 14 Death or severe injury due to a incorrect attribution of a triage code by the Central Operative unit 118 and/or in the Emergency Ward/ First Aid 15 Unforeseen Death or severe injury consequent to surgery

16 Every other adverse event that causes death or severe injury

*Indicate a single event for every signalling

* Event Date: |__|__| |__|__| |__|__|__|__| * Event Time: |__|__|: |__|__| (In case of gauze or other material left within the surgical site, the date refers to date of finding)

Discipline / Service: ...... …………………………………………………………………….. Place where the event occurred: Ambulance | _ | Ambulatory | _ | Bathrooms | _ | Corridor | _ | Home | _ | Ward | _ | Operating Room | _ | Stairs | _ | Critical Care | _ | Other | _ | (specify, such as emergency room, delivery room ...... ………………………………………………………………………….)

* Gender : M | _ | F | _ |

Year of Birth: |_|_|_|_|

Brief description of the event: ...... Outcome of the event (please tick one box):

Death | _ | Permanent disability | _ | Coma | _ | Disease state that causes prolonged hospitalization or chronic | _ | Greater trauma caused by patient fall | _ | Transfer to a semi-intensive or intensive care units |_ | Surgical reintervention | _ | Cardio respiratory resuscitation | _ | Request for specific psychological and psychiatric treatment as a result of attempted suicide or violence within the structure | _ | Result of AB0 incompatible transfusion reactions (regardless of the severity of damage) | _ | Other | _ |

If "Other", please specify (e.g. treatments with additional therapeutic drugs that would not otherwise be necessary, request of diagnostic tests of greater complexity, trauma and fractures resulting from falls) ......

Causes and factors that may have caused or contributed to the occurrence of the event: ......

All information provided will remain confidential. Send Form A The contact person for clinical risk management, if any, or a contact person identified by management, fills out Form A, sends it to the Ministry, also through their Region, at the time of the event or to the knowledge of it. Ministry of Health

Department of Quality Directorate General of Health Planning

NATIONAL OBSERVATORY ON SENTINEL EVENTS

FORM B

Analysis of the Causes and Contributing Factors and Action Plan

All the information provided will remain confidential. Ministry of Health Department of Quality Directorate General of Health Planning

NATIONAL OBSERVATORY ON SENTINEL EVENTS

Analysis of the Causes and Contributing Factors and Action Plan

1. SENTINEL EVENT

* Description of what happened, if possible through a flow chart (attached only if submitting in paper form) ……………………………………………………………………………………….. ……………………………………………………………………………………….. ……………………………………………………………………………………….. ……………………………………………………………………………………….. ……………………………………………………………………………………….. ………………………………………………………………………………………..

Indicate the method of analysis used for the analysis of the causes and factors that contributed to the occurrence of adverse events:

Audit | __ | RCA | __ | Other | __ |

If indicated "Other” , please specify ……………………………………………………………………………………….. ……………………………………………………………………………………….. *obligatory field

2. CAUSES AND FACTORS RELATED TO COMMUNICATION

2.1. Have causes or factors emerged related to the shortage/lack of information and communication?

Yes | __ | No | __ | N/A | __ |

If yes, please specify ...... …...... ………………………………………………………. …………………………………….

2.2 Have any inconsistencies emerged in the documents analyzed for the purpose of a clear understanding of the patient’s situation, treatment planning and patient response to treatment? Yes | __ | No | __ | N/A | __ |

2.3 Have inconsistencies emerged in communication between health professionals in managing the care process?

Yes | __ | No | __ | N/A | __ |

2.4 Have inconsistencies emerged in communication between health professionals and patients/families/carers, or rather patient and/or family members/carers have not been actively involved in the care process?

Yes | __ | No | __ | N/A | __ | 3. CAUSES AND HUMAN FACTORS

3.1. Have causes or factors related to inadequate training and operator training emerged? Yes | __ | No | __ | N/A | __ |

If yes, please specify ......

3.2. Have inconsistencies in operators’ skills/knowledge emerged? Yes | __ | No | __ | N/A | __ |

3.4 Have inconsistencies related to work organization (e.g. shift scheduling, fatigue, stress) emerged? Yes | __ | No | __ | N/A | __ |

4. ENVIRONMENTAL CAUSES AND FACTORS

4.1. Have causes and factors linked to the physical environment emerged? Yes |__| No |__| N/A. |__|

4.2. If yes, specify: Structural factors (appropriate facility) |__| Factors linked to logistics |__| Factors linked to the microclimate |__| Other |__| Specify ……………………………………………………………………

5. CAUSES AND FACTORS LINKED TO HEALTH TECHNOLOGY

A) Medical devices and electromedical equipment

5.1. Have causes or factors related to the use of medical devices and electromedical equipment emerged? Yes |__| No |__| N/A |__|

5.2. If yes, specify:

lacking |__| malfunctioning |__| incorrect use |__|

5.3. Specify to which category the device pertains to according to the National Classification (D.M. 22/09/2005)

Category Code |__| CND Code |__|

Description of instrument: ………………………………………………

5.4. Does a maintenance plan exist for the device in discussion?

Yes |__| No |__| N/A |__|

5.5 Has the preventative maintenance plan been respected (including updates or patch software) for the device in discussion?

Yes |__| No |__| N/A |__|

B) Pharmaceuticals

5.5 Have causes or factors linked to the use of pharmaceuticals emerged? Yes |__ | No |__| N/A |__|

5.6 If yes, specify

Lacking |__| incorrect use |__|

5.7 If use is incorrect, specify:

Prescription |__| Preservation |__|

Preparation |__| Administration |__|

C) Guidelines, Recommendation, Care Protocols, Procedures, Barriers

5.8 Causes and factors have emerged linked to: ACTION PLAN

Specify the actions taken after the results emerged from the investigation launched by the structure and in particular the analysis of the causes and contributing and/or determining factors of the sentinel event. Also indicate which professional profile (position) was in charge for monitoring the action (without specifying the name and surname).

* Description of action no. 1: ………………………………………………………………………………………... ……. ……………………………………………………………………...……. …………………

Professional profile in charge of action: ………………………………………………. …………………………………………………………………………………... …………. Indicator of measurable outcome: …………………………………………………………………………………………… …

Day action taken |__|__| |__|__| |__|__|__|__|

How often is action to be taken ( frequency): …………………………………………... (Specify if daily, weekly, monthly or other) Involvement of Healthcare Trust Management: Yes |__| No |__|

* Description of action no. 2: ………………………………………………………………………………………... ……. ……………………………………………………………………...……. ………………… Professional profile in charge of action: ………………………………………………. …………………………………………………………………………………... …………. Indicator of measurable outcome: …………………………………………………………………………………………… … Day action taken |__|__| |__|__| |__|__|__|__| How often is action to be taken ( frequency): …………………………………………... (Specify if daily, weekly, monthly or other) Involvement of Healthcare Trust Management: Yes |__| No |__|

* obligatory data

* Description of action no. 3: ………………………………………………………………………………………... ……. ……………………………………………………………………...……. …………………

Day action taken |__|__| |__|__| |__|__|__|__|

* Description of action no. 4: ………………………………………………………………………………………... ……. ……………………………………………………………………...……. ………………… Professional profile in charge of action: ………………………………………………. …………………………………………………………………………………... …………. Indicator of measurable outcome: …………………………………………………………………………………………… … Day action taken |__|__| |__|__| |__|__|__|__| How often is action to be taken ( frequency): …………………………………………... (Specify if daily, weekly, monthly or other) Involvement of Healthcare Trust Management: Yes |__| No |__|

* obligatory data

Method to send Form B

Health facilities send Form B of the Protocol to the Ministry, as follows: the contact person for clinical risk management, where available, or a contact person identified by management, fills out form B for the analysis of the causes and contributing/determinants factors and sends it to the Ministry. It can also be sent thorough one’s Region, within 45 calendar days from the occurrence or from knowledge of the event and from the dispatch of Form A. Ministry of Health

Department of Quality Directorate General of Health Planning

NATIONAL OBSERVATORY OF SENTINEL EVENTS

Ghirardini Alessandro, Director of the 3rd Office [email protected] Andrioli Stagno Roberta [email protected] Cannizzaro Giandomenico [email protected] Cardone Rosetta [email protected] Carnevale Guerino [email protected] Ciampalini Susanna [email protected] Colonna Antonella [email protected] De Feo Angela [email protected] Furlan Daniela [email protected] Leomporra Giorgio [email protected] Matera Carmela [email protected] Mirandola Gaia [email protected] Patisso Maria Concetta [email protected] Seraschi Claudio [email protected] GLOSSARY

For the purpose of Sentinel Event Monitoring the following terms are noted:

Damage: alteration, temporary or permanent, of a body part or a physical or mental function (including perception of pain).

Error: failure in planning and / or execution of a sequence of actions that determines the failure of the objective desired, the failure is not attributable to chance.

Error in treatment (medication error) Any error that occurs in the process of managing medication can be represented by: . Prescription error Involves both the decision to prescribe a drug and the written medical prescription . Error transcription / interpretation Concerns the misunderstanding of some or all of the prescription and/or abbreviations and or writing . Error construction/preparation Occurs in the preparation or handling of a drug prior to administration (for example, incorrect dilution, mixing of incompatible medications). This can happen either when the drug is prepared by health care workers as well as when prepared by patient . Error distribution Occurs during the distribution of the drug when it is distributed by the pharmacy to the operating units or patients . Error administration Takes place during the administration of the treatment by health workers or other care givers, or when the drug is taken independently by the patient.

Outcome Changes in health conditions as a product of medical treatments provided.

Event (Incident) Occurrence that gave or had the potential to lead to unintentional and/or unnecessary injury to patient.

Adverse Event: unexpected event related to the care process and which involves an unintended and undesirable injury to the patient. Adverse events may be preventable or not preventable. An adverse event attributable to error is "a preventable adverse event". Adverse Drug Event Any adverse event that occurs during drug therapy, as a result of the use or not of a drug, however not closely related to the action of the drug itself. Adverse drug events include: . preventable adverse drug events, or caused by an error in treatment . non preventable adverse drug events, which occur despite appropriate use, defined as "adverse drug reactions (ADR).

Sentinel Event Particularly serious adverse events, potentially indicative of a serious system malfunction, which may result in death or serious harm to the patient and determining a loss of confidence among citizens for the health service. Because of its gravity is enough to occur only once because it is expedient immediate investigation to determine what factors have caused the elimination or reduction, or have contributed to and triggering the implementation of appropriate corrective measures by the organization.

Guideline Recommendations made in a systematic way, based on scientific evidence to assist health professionals and patients in decisions about what procedures to take appropriate care in specific clinical circumstances.

Procedure Specified way to perform a process.

Diagnostic / therapeutic procedure Any kind of diagnostic / therapeutic intervention regardless of the complexity of the health service.

Care protocols Local adaptation of international guidelines and / or national reference to the needs and to the logistical and organizational, structural and technological characteristics of the healthcare facility that adopts and implements them.

Recommendations for patient safety Under the system of monitoring of sentinel events proposed by the Ministry of Labour, Health and Social Affairs, are all indications addressed to medical facilities and / or professionals aimed at reducing the risk of occurrence of adverse events and produced by institutions of the NHS.

Adverse Drug Reaction An unwanted, unintended, harmful and non-preventable response to a drug, which occurs at doses normally used in humans for prophylaxis, diagnosis, therapy or to restore, correct or modify physiological functions. Health facilities: Where health service are offered, for example

Health Trust - University Teaching Hospitals and General Hospitals (Polyclinics) Health Trust Private and Accredited Nursing homes National Research Council Rehabilitation Institutes Scientific Institutes for Care and Recovery Psychiatric hospitals Rehabilitation Centres Hospitals Hospitals Managed by Local Health Authority Ambulatories and Laboratories Long-term Care Structures Short-term Care Structures Other types of Outpatient Facilities

N.B. This list has been prepared based on database to which SIMES is linked