Policy AD-105 Reporting of Adverse Events and Near Misses (Incidents) 2021-07-16

Purpose

Westside Family Healthcare (Westside) endorses and supports a culture of safety and views incident reporting as a means of improving systems and processes in providing healthcare services to all patients. In a continuing effort to promote a safe environment for patients, Westside will conduct a systematic program of incident reporting. Reporting is non-punitive, and all employees are required to report all incidents.

Westside intends to limit disciplinary action to only those individuals who engage in willful or malicious misconduct, exhibit continued noncompliance with established policies and procedures for patient care and/or safety, or repeatedly fail to follow recommendations to improve skills.

Westside strives to facilitate education and problem resolution through forthright disclosure of process failure and/or human error.

Policy

Reporting of adverse events and near misses (“incidents”) is an essential component of the risk management program and is part of the performance and quality improvement process.

Incident reports may not be copied or otherwise disseminated, except where required by law or for insurance coverage of an incident, and as approved by Westside’s Risk Manager (Chief Operating Officer).

While the circumstances surrounding an incident, all information contained in the incident report, and any follow-up reports are confidential, Westside fully supports the practice of fully informing patients and family members or designated representatives of errors affecting patients under one or both of the following circumstances:

• When some unintended act or substance reaches the patient and results in harm; or
• When there is potential clinical significance of the event to the patient.

In these situations, Westside will utilize its Sentinel Event policy.

In addition, Westside will give consideration to disclosing errors that reach patients and do not result in harm. The decision to disclose these errors will depend on the circumstances of the incident and the patient. Responsibility for disclosing the error usually rests with the provider who has overall responsibility for the patient’s care; however, the Associate Medical Director of Population Health and Quality should be consulted regarding best approaches for communication of the information about incidents to patients.

An employee involved in incidents subject to this policy will not be subjected to disciplinary action EXCEPT in the event any of the following:

• The employee fails to report an incident as soon as possible after discovering that the incident has occurred and in accordance with incident-reporting procedures;
• The employee is directly involved in sabotage; malicious behavior; patient mistreatment, abuse, or neglect; chemical impairment; or criminal activity;
• The employee provides false information on the incident report or during the follow-up investigation; or
• The employee fails to respond to educational efforts and/or to participate in the education process or other performance improvement plan.

Employees who meet any of the exceptions listed above will be subject to disciplinary action in accordance with organization policy.

Scope

This policy applies to all employees.

Definitions

An adverse event is an undesired outcome or occurrence, not expected within the normal course of care or treatment, disease process, condition of the patient, or delivery of services.

A near miss is an event or situation that could have resulted in an accident, injury, or illness but did not, either by chance or through timely intervention. Westside regards near misses as opportunities for learning and for developing preventive strategies and actions.

An incident is an adverse event or a near miss.

Examples of incidents that employees are required to report include, but are not limited to, the following:

• Any condition or situation that could have caused or did cause injury to a patient (e.g., a medication error or adverse reaction, fall, delay in delivery of needed care or unexpected death);
• Any condition or situation that could have resulted or did result in an injury to a patient (e.g., failure to follow up on abnormal test results, scheduling problem or equipment malfunction);
• Failure to comply with established policy or protocol, with or without patient, provider, employee, or visitor injury; and/or
• Any injury, potential injury, or unusual occurrence involving a patient, visitor, or employee on the facility grounds (e.g., due to a fall or falling object).

Procedures

Response and Reporting

1. If needed, on-site healthcare providers will immediately evaluate and stabilize the patient or other individual involved in an incident.
2. After any needed intervention has been provided to the patient or other involved individual, the person most knowledgeable about the incident will complete an incident report.
3. Each employee shall be responsible for reporting all incidents as soon as the employee discovers them.
4. The employee must inform the employee’s immediate supervisor and make a report of the incident via the on-line Incident Report system.
5. The person making the incident report is to be objective and accurate and to refrain from drawing conclusions, engaging in criticism, or placing blame.
6. The incident report will include data elements based on the incident type including:
   1. Date and time of the incident
   2. Date and time of the report
   3. Name of person submitting the report
   4. Office site of incident
   5. Location of event within the office site
   6. Name of the person to whom the incident was reported
   7. Whether the incident was witnessed or not witnessed
   8. Witness contact information, if witnessed
   9. Event type
   10. Equipment related to the incident, if any
   11. Description of injury, if any
   12. Injury type
   13. Type of medication incident, if applicable
   14. Event description, in detail
   15. Patient or witness comments
   16. Outcome

External Communication

• 1. The Chief Operating Officer (COO), or the COO’s designee, will notify external regulatory or accrediting agencies of the incident as required in accordance with state and federal statutes and regulations or accreditation standards (e.g., Joint Commission). Examples of external reporting requirements may include reporting to the U.S. Food and Drug Administration under the Safe Medical Devices Act or to state agencies.
  2. The Chief Operating Officer (COO), or the COO’s designee, will notify insurers (e.g., liability, property, Workers’ Compensation) in accordance with established notification procedures.

Root-Cause Analysis

• 1. Root-cause analysis is a process for identifying the basic or causal factor(s) that underlie the occurrence or possible occurrence of an incident.
  2. Per Westside’s Sentinel Event policy, a root-cause analysis should be conducted for all serious or potentially serious incidents.
  3. The information and learning from the root-cause analysis will be used to facilitate systems improvements to reduce the probability of occurrence of future related incidents.

Investigations

• 1. The Director of Site Operations (DSO) will review each Incident Report and assign the Incident Report to the appropriate Manager, Director, or Chief who will be responsible for conducting follow-up investigations. The DSO will also notify the manager of the service or site, as applicable.
  2. An investigation will be conducted, at minimum, for any of the following:
     1. Per Westside’s Sentinel Event policy, any incident that may have contributed to or caused temporary or permanent harm, initial or prolonged hospitalization, or death, to an employee, patient or visitor.
     2. Any significant adverse drug reaction or significant medication error.  A significant medication error is defined as unintended, undesirable, and unexpected effects of a prescribed medication or medication error that requires discontinuing a medication or modifying the dose, initial or prolonged hospitalization, or treatment with a prescription medication; results in disability, cognitive deterioration or impairment, congenital anomalies, or death; or is life-threatening. Westside’s Sentinel Event policy will be followed, as applicable.
     3. Any unplanned instance of a patient being hospitalized, or transferred to the emergency department or other higher level of care, directly from the health center or clinic as a direct result of the incident.

Documentation in the Medical Record

• 1. Documentation in the patient’s medical record shall include:
     1. Date and time of the incident;
     2. A factual account of what happened;
     3. Name of provider notified and time of notification (if applicable);
     4. Patient’s condition after the incident; and
     5. Any treatment or diagnostic tests rendered as a result of the incident.
  2. Documentation in the medical record shall not state whether an incident report was completed.

Retention of Event Reports

• 1. Incident reports shall be retained for the period of time identified in Westside’s document retention policy.

References

1. ECRI Institute