2 of 33 Medical Safety Reporting It is the policy of the DMC to report all incidents, accidents, or occurrences that cause or could potentially cause injury or harm to an employee, patient or visitor in the DMC: See DMC policy 1 CLN 026 Incident Reporting for additional information or clarification
3 of 33 Medical Safety Reporting Most events or errors occur due to process issues: Multiple events at multiple levels lead to the event – almost never just one process failure Rarely a “person” failure
4 of 33 Medical Safety Reporting The DMC supports a blame-free environment: All employees are encouraged and urged to report all events and occurrences By reporting all events that occur, we can investigate and get to the root cause of the error By getting to the root cause of an error, we can fix the underlying system or process issues
5 of 33 Medical Safety Reporting What to report: Error - An unintended act, either of omission or commission. Near Miss - Used to describe any process variation which did not affect the outcome, but for which a recurrence carries a significant chance of a serious adverse outcome. Hazardous Condition - Any set of circumstances (exclusive of the disease or condition for which the patient is being treated), which significantly increases the likelihood of a serious adverse outcome.
6 of 33 Incident Reporting: Types of Incidents Adverse Drug Event: Adverse Drug Reaction: Unexpected, unintended, undesired or excessive response to a medication. Medication Variance: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer.
7 of 33 Types of Incidents: - continued Patient Incident: Any patient related incidents, including lost or damaged patient belongings. Employee Incident: Any employee incident, including workplace conflict. Visitor Incident: Any incident that involves or affects a visitor. Property Incident: Lost or damaged property belonging to visitors or employees of the DMC. These type of incidents are reported directly to Security.
8 of 33 Patient Incidents: Patient Incidents are any events that involves the patient including but not limited to: - Patient injury including falls and hospital acquired pressure ulcers or infection. - Missed, delayed or wrong treatment or procedure. - Medication events that involved a patient. - Breach of patient confidentiality (HIPPA violations). It is also necessary to document patient incidents in the medical record. - An objective note should be placed in the patient’s medical record documenting the facts and events of the occurrence, physician findings and treatment. DO NOT document that an incident report has been filed or refer to the incident #.
9 of 33 Patient Incidents Involving Medical Devices: Medical Device Incidents: Incidents in which a medical device may have caused a patient’s death, serious illness or injury or has information critical to the investigation. A medical device may be a piece of equipment (IV pump, cardiac monitor or a patient care item (such as foley catheter). Remove device from service, tag it and report incident immediately. See 1CLN 017 Safe Medical Device Act.
10 of 33 Patient Incidents Involving Medical Devices con’t : Keep device/equipment on unit. If device was electrical and plugged in – DO NOT unplug Notify Risk/Quality/Biomed immediately Biomed must be notified if telemetry device was involved and must retrieve data from device as soon as possible.
11 of 33 Medical Safety Reporting Definitions: Unexpected Clinical Event: any clinical event that is not an expected part of the patient’s care or condition, which occurs in the hospital that may or may not have been preventable and may or may not have resulted in harm. Reviewable Event: is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events signal the need for immediate investigation and response (also referred to as “Sentinel Events” by the Joint Commission). Serious reportable event: Events that are of concern to both the public and healthcare professionals and providers, clearly identifiable and measurable; and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the healthcare organization (also referred to as “never events”).
12 of 33 Unexpected Clinical Events An Unexpected Clinical Event is an unanticipated death or major permanent loss of function not related to the natural course of the patient's illness or underlying condition. All reviewable events and serious reportable events are unexpected clinical events. Unexpected clinical events need to be reported immediately to the department manager and also entered into the web- base reporting system. The manager will then immediately notify risk management and the Chief Medical Safety Officer. See 1 CLN 027 Unexpected Clinical Events
13 of 33 Reviewable Events (“Sentinel Events”) and Serious Reportable Events (“Never Events”): In the event of any Joint Commission defined sentinel, any NQF serious reportable event (“never event”) or other significant events, the following needs to occur at the site: Site quality will notify corporate quality (a phone call to CQSO; if away then the director of quality) and hospital leadership. Start local investigation. If this is a reportable event, investigation must be complete within 10 days. Circle back to attending physician to ensure that communication with patient/family has occurred.
14 of 33 Reviewable Events (“Sentinel Events”) As defined by the Joint Commission, reviewable events include: Suicide, Homicide, Rape or Elopement Infant discharge to the wrong family. Abduction of any individual receiving care, treatment or services. Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities. Surgery on the wrong patient or wrong body part. Unintended retention of a foreign object in an individual after surgery or other procedure. Death or major permanent loss of function as a direct result of a healthcare associated infection, medication error, or patient fall.
15 of 33 National Quality Forum’s (NQF) Serious Reportable Events (“Never Events”) Some examples of Serious Reportable Events: All the JC Reviewable Events Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility There are 28 NQF Serious Reportable Events. They are reviewed and updated annually. If a serious reportable event (never event) occurs, the DMC CQSO will notify Patient Finance Services who will waive all charges directly related to the event and refrain from seeking reimbursement from the patient or third party payor.
16 of 33 Employee Incidents: Employee Incident is any event occurring in the DMC or on the premises to an employee that is not consistent with the employee’s routine work, and may adversely affect or threaten to affect the health, life, comfort, or property of an employee. Occurrences to be reported include (but are not limited to): - Slip, trips and falls. - Needle/sharps injuries and splashes of blood or body fluids to the eyes, nose, mouth or non-intact skin. - Other incidents that result or may result in injuries to employees, including potential Workers’ Disability claims and incidents which require MIOSHA filing. - Incidents of workplace conflict and/or verbal, physical, or emotional abuse or harassment - see 1 HR 507 Prevention of Workplace Violence.
17 of 33 Reporting Employee Incidents: All employee incidents are reported to the department manager and entered into the web based incident reporting system. The Employee Injury/Illness Report is also completed per MIOSHA regulations. The employee is to report to the Emergency Department or Occupational Health as per site protocol. The employee takes the Employee Injury/Illness Report with them when they report for evaluation or treatment to the ED or OHS.
18 of 33 When Should You Report An Incident? As soon as it happens or as soon as you find out about it. - See 1 CLN 026 Incident Reporting Policy.
19 of 33 How To Report An Incident: The DMC uses a web-based incident reporting system that allows our organizations to report, track, and prevent medical errors and near misses. All Detroit Medical Center employees can access the web based reporting system for the purpose of incident, near miss reporting and complaint reporting. Web-base incident reporting can be accessed using the desktop icon or through the Intraweb (select “Incident reporting” under the Quality and Safety tab) on any PC workstation with Internet access.
20 of 33 Incident Reporting: To access web-based incident reporting: Select the incident reporting icon (or tab on intraweb home page), Select SRM 5.0 then select Patient, Employee, or Visitor to report an event, If you are unable to access the web-based incident reporting system using the internet for any reason, a paper form will be available.
21 of 33 Incident Reporting – Staff Responsibilities : Staff will enter any patient, visitor, employee, medication or workplace conflict related incidents or near misses into web-based incident reporting system or report the incident to a supervisor for entry into the web-based incident reporting system. Staff will report any work-related accident, injury, or near miss to their supervisor or department manager immediately following the occurrence.
22 of 33 Incident Reporting – Management Responsibilities : If paper form was used to report the incident, department manager or designee will enter information into the web-based incident reporting system and destroy paper form after entry. Managers or their designees review incidents involving their respective areas. Investigate incident, interview employee(s) and if appropriate, determine additional factual information. Add any missing information regarding circumstances. Review level of impact and adjust as appropriate. Refer reports to other involved departments as indicated. - Complete entry of the data components, including follow-up investigation and corrective actions. - Events are to be reviewed and have documented follow-up within 7 days of event entry.
23 of 33 Incident Reporting – Management Responsibilities: - cont. Department Manager, Site Administrator, Risk Management and Quality Department are notified of any situation which may have the potential for significant negative outcomes, serious patient injury or adverse media attention. In these situations, refer to the Unexpected Clinical Event policy 1 CLN 027 for further information or direction. Notify the Safety Officer to report unsafe conditions or hazards. Report any employee lost time to Human Resources/Regional Workers’ Compensation Administration within 24 hours of incident. Identify, implement, educate and document actions taken to lessen likelihood of incident recurring.
24 of 33 Incident Reporting – Other Department Responsibilities: Pharmacy: - Pharmacy reviews and closes all medication related events. - If a drug is reported to the FDA Medical Products Reporting Program (MEDWATCH), pharmacy will document this in the “follow up” section of the incident report. Clinical/Quality Improvement: - Clinical/Quality improvement reviews incidents. - Clinical/Quality improvement closes all events with level of impact category F or higher. If event is referred to peer review, or RCA/IA is being conducted, document statement in follow up section.
25 of 33 Patient, Family and Visitor Complaints: The DMC encourages patients, families and visitors to freely express their grievances, complaints, concerns, dissatisfactions and inquiries through established channels without being subject to coercion, discrimination, reprisal, or unreasonable interruption of care, treatment, and services. Definitions: Medical Grievance: Any complaint (written or verbal) that involves treatment or care of the patient, including complaints against physicians.
26 of 33 Patient, Family and Visitor Complaints: Complaint: Any expression of dissatisfaction related to an occurrence that it is not able to be resolved to the satisfaction of the patient/family at a departmental level and/or crosses multiple service lines or departments (some examples include billing issues, delay in service, or environmental concerns). Concern/Dissatisfaction: Any expression of concern or dissatisfaction that is resolved to the satisfaction of the patient/family at the departmental level (some examples include food temperature, TV or phone problems).
27 of 33 Complaint Management: When a grievance, complaint or concern is received, IMMEDIATE resolution at the department level is attempted. If the complaint is not immediately resolved, contact the appropriate management staff for intervention, and enter the complaint into the DMC web-based Incident and Complaint reporting system.
28 of 33 Complaint Reporting: To access web-based incident reporting: Select the incident reporting icon (or tab on intraweb home page), Select Feedback to report a complaint
29 of 33 Complaint Management: - continued The Patient & Guest Relations Representative or other facility designee, will review all complaints and determine if it will be classified as a Medical Grievance, Complaint or Concern/dissatisfaction and offer assistance and intervention in bringing the matter to closure: See policy 1 CLN 033 Patient and Family Grievances and Complaints The Patient & Guest Relations Manager closes all complaints entered into the web-based incident reporting system. Complaint management outcomes data is used to identify opportunities for improving patient/family services throughout the Detroit Medical Center.
30 of 33 Compliance Hotline: ETHICS May report non-environmental issues such as harassment. Calls can be placed by patients, visitors or employees. Reporting may be done anonymously. Means to immediately report hazardous conditions and other environment of care issues (examples – icy walkways, elevator problems). - You may also call your site Safety Officer
31 of 33 Quality of Care As employees of the DMC, it is everyone’s responsibility to ensure safe, quality care for our patients. Also, as an employee, you have the right and duty to speak up if you feel the quality of care or patient/employee safety is compromised. If you have concerns, first speak to your supervision. If you are not satisfied, you may contact the Quality Department or use the compliance hotline. If still you concerns are not addressed, you have the right to Joint Commission at of Quality Monitoring (630)
32 of 33 Summary Types of incidents to be reported include patient, employee, visitor and property. The DMC supports a blame free environment and employees are encouraged and urged to report all events and occurrences. Incidents should be reported as soon as they occur or are known. If a medical device is involved in the incident, remove device from service, tag it and report incident immediately. Incidents and near miss events are reported and entered into the web-based incident reporting system. Immediate action is taken to address/resolve any patient, family or visitor complaint. Anonymous reporting using the Compliance hotline may be used to report non-environmental issues such as harassment.
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