The healthcare industry has been searching for ways to improve patient safety since the release of the Institute of Medicine’s (IOM) To Err is Human report on November 29, 1999.¹ Incident reporting and tracking are important elements of healthcare that enhance patient safety and quality of care.² Incident reporting should be part of every healthcare setting, including office-based care settings. Unforeseen circumstances such as safety events, adverse events, and unexpected complications can and do occur. Although most of us believe “it will never happen to us,” it is important to anticipate the unexpected.¹
An incident report provides a standardized method for documenting and addressing events that may involve a patient, visitor, or employee that are outside the normal day-to-day activities.³ Although this article will focus on patient safety incident reporting, it is important to also have a process for incident reporting involving visitors and employees.
A patient safety event is an incident or condition that could have resulted, or did result, in harm to a patient.4 Patient safety events include, but are not limited to medication errors, allergic reactions to medications, falls, infections, procedure complications, misdiagnosis, delay in diagnosis, or any other unexpected event that compromises the safety or well-being of a patient. The California Medical Association (CMA) indicates the primary focus of patient safety event reporting is to identify, analyze, and prevent such incidents from happening again to enhance patient safety and quality of care.5
Incident Reports help us:²
- Learn from mistakes by identifying trends, analyzing root causes, and making changes
to prevent similar incidents in the future. - Track progress by measuring improvements over time. This allows proactive actions to create a safer environment.
- Track trends for any reoccurring issues and/or trends that may point to a larger problem.
- Improve risk management by taking proactive action to minimize risk exposure.
- Take actionable steps by deciding follow-up actions to prevent future incidents. This may include changes to policies and procedures.
ECRI conducted a study of safety events occurring in office-based settings, including ambulatory care centers, community health centers, and primary care provider offices.6 The safety events fell into four main categories:6
- Diagnostic testing errors
- Medication events
- Falls
- Security or safety incidents, such as workplace violence.
The Incident Report
Incident reporting is the most common method of risk identification. Developing an incident reporting policy should be a priority, beginning with an incident form that is easy to use and understand. The form should capture the following information:7
- Date of incident
- Time of incident
- Type of incident
- Location of incident
- Individuals involved
- Witnesses
- Detailed description of the incident
- Any injuries sustained
- Photo evidence of the incident
- Action taken to address the incident
- Assistance services provided to patient
- Outcome of the patient (e.g., transported by paramedics to the hospital; transported home with son, left on own accord in no distress)
The practice should ensure that all staff are trained in incident reporting procedures and understand their roles and responsibilities. Training should emphasize the importance of reporting incidents promptly and accurately without fear of reprisal. By simplifying the process of reporting incidents, you enable your employees to embrace their mistakes, learn from them, and advance in their professional development.7
Incident reports are internal documents and should never be given to the patient and/or family, nor added to the patient’s health record.³ They are confidential documents that should be used for investigation and internal process changes to improve patient safety. Think of the incident report as a tool to continuously improve your process.3 Adhere to patient confidentiality guidelines when documenting patient safety events. Only share information on a need-to-know basis and store the documentation in a secure location, whether physical or digital.
The Medical Record
Ensure that a clear and concise summary of the incident is documented in the patient's medical record. The documentation should be brief and factual. Include relevant details such as the nature of the event, actions taken, and any follow-up measures. Record any conversations or interactions with the patient or their family regarding the safety event. This includes discussions about the event itself, questions by the patient and/or family, and any actions or recommendations provided to address the event. Follow the guidelines below:8
- Document only objective observations or known facts.
- Complications that were manifested during care should be reflected.
- Document specifically what the patient/family was told.
- Do not blame other professionals or facilities in the medical record.
- Do not use defensive or blaming documentation.
- Do not change anything previously written. An addendum may be included as facts become available by dating the addendum on the day it is written.
- Do not document the call to your professional liability carrier.
- Do not document that an incident report was completed.
Be mindful that others, including your patient, may read your documentation.
You should also note some safety events that occur in office-based settings that have mandatory and/or voluntary reporting requirements to outside regulatory agencies:
OSHA Reporting Requirements | OSHA Recordkeeping and Reporting |
VAERS-Vaccine Adverse Event Reporting | VAERS Reporting |
Mandatory Patient Notification of Sterile Compounded Drug Recalls by Pharmacies, however the Business & Professions Code §4126.9 states: If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. | Business & Professions Code §4126.9 |
Voluntary Reporting of Adverse Events involving Medication(s) or Medical Device | FDA MedWatch |
In summary, remember that incident reports play a pivotal role in patient safety. By documenting and tracking safety events, you will be able to understand and identify patient safety concerns in your office-based setting, anticipate issues, and address them to reduce your risk exposure. Incident reports help identify areas for improvement, help identify preventative measures, and ultimately enhance patient safety and quality of care provided by your medical practice.
Check with your medical professional liability carrier regarding discoverability of incident reports.
Rikki Valade RN, BSN, PHN, is a Senior Risk Management and Patient Safety Specialist. Questions or comments
related to this article should be directed to RValade@CAPphysicians.com.
References
¹Donaldson, Molla Sloane. “An Overview of To Err is Human: Re-emphasizing the Message of Patient Safety.” National Library of Medicine: Pub Med. Patient Safety and Quality: An Evidence-Based Handbook for Nurses, edited by Ronda G Hughes, Agency for Healthcare Research and Quality (US), April 2008. https://www.ncbi.nlm.nih.gov/books/NBK2673/
²What is Incident Reporting and Why is it Important. Risk Connect, (2024).
https://riskonnect.com/health-safety-management/what-is-incident-report…
³Cynthia Saver, Nursing Service Organization (NSO), Incident reports: A Safety Tool, (2024). Incident reports: A safety tool | NSO
4Patient Safety Event, Health.mil. 7/26/2023 https://www.health.mil/Reference-Center/Glossary-Terms/2023/07/26/Patie…
5California Medical Association (2024), California Physician Legal Handbook; Document #3600 Medical Error and Adverse Events: Voluntary Systems and Reporting. Document#3600 (pg. 2).
6Ricciardi R, Lee M, Mossburg S., Patient Safety in Office-Based Care Settings; Agency for Healthcare Research and Quality (2024). https://psnet.ahrq.gov/perspective/patient-safety-office-based-care-set…
7Amber Ratcliffe, MedTrainer, Understanding the Importance of Incident Reporting in Healthcare. 2024 https://medtrainer.com/blog/incident-reporting/
8Cooperative of American Physicians, Inc. The Physician’s Guide to Handling Adverse Outcomes, (pg. 11) (2016)