As a Physician or an Healthcare Administrator What am I required to Report?
Who Must Report:
In a hospital or a healthcare provider entity, any employee or agent of that hospital or entity. It must be reported to the administrative office of the entity, it could be one of multiple departments: risk management, compliance, administrative office, or any of the heads of those departments. The reason for reporting is that the "incident" may affect patient safety, adversarial claims, or regulatory oversight requires it. Plus, you may soon have a complaint filed against your professional license.
What NOT to do:
Initially, do not report this by email or in writing until you have spoken with someone. They will guide you as to when and how to go about putting it in writing. The reason not to put it in writing is to first confirm what is the best way report the incident, whether the incident has already been reported, and not trip all the other regulatory requirements that kick in if you report the wrong incident to the wrong department and through the wrong channels. HOWEVER, if the situation is such that you believe your personal employment, career, or more importantly your license is on the line, then its best to discuss this with a person who you can take into confidence and who would have an understanding how this area of practice and the rules work. You are also welcome to call us.
What is an Incident or Occurrence that is potentially reportable:
- any event that has produced an actual, potential or perceived injury;
- any practice, process, situation, premises or product defect that may result in an injury if left uncorrected;
- any other unexpected adverse event where established policy or procedure was not followed; and/or
- any other condition or event you feel may give rise to a claim or complaint.
What MUST be Reported:
- Medication errors leading to injury, death, or higher level of care
- Retained foreign body incidents
- Wrong site, wrong patient, wrong procedure
- Any incident that results in an unexpected death, brain or spinal damage, or any other injury not referenced above
- Total or partial loss of a limb or loss of the use of a limb
- Sensory organ or reproductive organ impairment
- Any injury to a part of the anatomy not undergoing treatment
- Disability or disfigurement
- Any assertion by a patient or patient's family that he/she has been medically injured
- Misdiagnosis of a patient's condition resulting in mortality or increased morbidity
- Injury/death to either the child or mother during delivery
- Any shoulder dystocia resulting in a fracture or other injuries
- Any assertion by the patient/family that no consent for treatment (medical/surgical) was given
- Any assertion or evidence that the patient was sexually abused, raped, or otherwise sexually assaulted
- Any other condition or event you feel may give rise to a claim or complaint
Formal Complaints and Allegations against a Healthcare Licensed Professional
Complaints come in two forms and potentially a third. The first form is a complaint against a professional's or an entity's license, usually filed by the patient or their family with a state or federal agency. The second is a civil law suit related written statements alleging negligence and related assertion of legal claims typically sent by an attorney. The third possible type of complaint is one when there is an egregious behavior, that could lead to criminal prosecution. If either version of these complaints is filed, its time for you to seek legal counsel. The legal licenses involved have too much invested and the consequences are far too great to not involve an attorney. The legal fees for such an item are typically less than $10,000 and more than $3,000, incurred over typically a 6 month to a year long period. It is best to find an attorney who understand both the healthcare ramifications and the litigation ramifications. The assertions of the complaint typically include statements:
- that an injury has occurred.
- that proper consent was not given for treatment.
- that there has been sexual misconduct.
These also include any legal or regulatory agency communications, including:
- Notices of Intent to Initiate Litigation for Medical Negligence.
- Summons and Complaints.
- Letters or phone calls from the Agency for Health Care Administration (AHCA) or the Department of Health (DOH).
- Letters or phone calls from an attorney.
If you are interested in how Adverse Incidents are reported, below is the NPDB Guide Book, it is a "gem" of a book that very few people go to and figure out how to report and respond to complaints:
If you are involved in any of such an incident, it is best to involve an attorney that can guide you through this process.