Browsing articles in "Risk Management Bulletin"

Disclosure of Adverse Events

September 6, 2024

Dear Policyholders:

We often receive calls about steps to take when disclosing an adverse event that was a result of a medical error or an unanticipated outcome. Studies have shown that transparency and empathy can strengthen the physician-patient relationship and potentially reduce the chance of litigation. There are legal and ethical considerations to be aware of when communicating to patients about the details of adverse events. For our detailed risk management recommendations, please consult our Disclosure of Adverse Events resource.

Below is a summary of recommended steps to consider in the disclosure process:

1) Focus on the patient’s condition and treatment needs.
2) Preserve any evidence related to the event.
3) Contact risk management for advice.
4) Debrief with the staff involved to gather facts.
5) Develop a disclosure plan.
6) Disclose the facts of the event to the patient and/or family.
7) Advise of possible short-term or long-term effects of any injury resulting from the event and the next steps in the treatment.
8) Share your contact information and follow-up time frames to set expectations and alleviate concerns.
9) Document disclosure communication with the patient and/or family in the medical record.
10) Perform a root cause analysis.
11) Report the incident to the facility and your medical professional liability carrier.
12) Offer support to staff affected by the event.

If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or call us at 1-800-562-6642 and enter 4 for Risk Management.

FTC Updates the Eyeglass Rule

Risk Management Bulletin // No Comments

August 7, 2024

Dear OMIC Insureds:

We would like to bring your attention to updates made to the Ophthalmic Practice Rules (Eyeglass Rule) on June 27, 2024, by the Federal Trade Commission (FTC).

The FTC proposed updating the rule in December 2022 after receiving over 800 public comments regarding ophthalmologists’ and optometrists’ noncompliance with the rule’s longstanding requirement to provide patients with a free copy of their prescription immediately after a refractive eye exam. The updates are intended to increase compliance foremost by requiring certain prescribers to obtain a patient’s signed confirmation of receipt of their prescription. OMIC encourages you to read the FTC announcement here to ensure your practice is in compliance. The announcement lists the following changes, which go into effect September 24, 2024:

“The changes announced today require that prescribers, after providing the prescription, request that their patients sign a statement confirming they received their prescription and keep a record of such confirmation for at least three years. These new confirmation requirements—which mostly mirror those already in place for contact lens prescriptions—only apply to optometrists and ophthalmologists who have a financial interest in selling prescription eyewear.

Other changes to the rule:

allows prescribers, with a patient’s verifiable affirmative consent, to provide the patient with a digital copy of a prescription in lieu of a paper copy; if the patient refuses the digital copy, the prescriber must provide a paper copy;
explicitly specifies that, whether the patient consents to digital delivery or opts for a paper copy of their prescription, the prescription must be provided immediately after the examination is completed (not after the patient has been sold glasses, for instance). A patient must have their prescription before any offer to sell them glasses;
clarifies that presentation of proof of insurance coverage shall be deemed to be a payment for the purpose of determining when a prescription must be provided;
changes the term “eye examination” to “refractive eye examination” throughout the text and emphasizes the need for prescribers to educate consumers that there can be a difference between an eye health examination and a refractive eye examination. This is because the automatic release of prescriptions is only required following a refractive eye examination.”

If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or call us at 1-800-562-6642 and enter 4 for Risk Management.

Sincerely,

OMIC Risk Management Department

Risk Management Update: Biosimilars to Treat ROP

Risk Management Bulletin // No Comments

June 25, 2024

Dear Colleague:

We would like to provide you with an update on the use of biosimilars to treat ROP.
FDA-approved biosimilars are now available for bevacizumab, ranibizumab, and aflibercept for a variety of diseases. However, data on their use in ROP are very limited or absent with respect to plasma levels of drug at multiple time points, alteration of disease course, visual outcomes, and neurodevelopmental status.
Until such data become available, biosimilar drugs should NOT be used to treat ROP.

Download OMIC’s revised consent for treating ROP with injection which reflects this update on the use of biosimilars.

Contact your underwriter for any questions about coverage. Find my underwriter on OMIC’s webpage can give you the name, email address, and phone number of the underwriting contact for your state.

Remember that you may contact the Risk Management Hotline for confidential assistance by emailing us at riskmanagement@omic.com or calling 800-562-6642, option 4.
Sincerely,

R. Michael Siatkowski, MD
Chair of the OMIC ROP Task Force
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Anesthesia Liability

Risk Management Bulletin // No Comments

July 8, 2024

Dear OMIC Insureds:

The Risk Management Department is aware of the national shortage of anesthesiologists. Ophthalmologists are relying more on CRNAs, and in some states, RNs, to administer anesthesia. When assessing their potential liability for anesthesia administered by such healthcare providers, ophthalmologists should consider the following factors:

Location of the procedure
Administration of anesthesia (who is giving it, what is being given, and by what method)
Monitoring of the patient
Level of sedation
Patient selection criteria
Pre- and post-procedure instructions
Emergency response plan

Although each state has its own laws that will affect your evaluation of these criteria, considering these factors will aid in legal and administrative compliance, patient safety, and risk mitigation. To better protect yourself from anesthesia liability exposure, please click here to access OMIC’s risk recommendations regarding each of these factors.

If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or call us at 1-800-562-6642 and enter 4 for Risk Management.

Sincerely,

OMIC Risk Management Department

Time-Outs for Procedures

Risk Management Bulletin // No Comments

June 7, 2024

Dear OMIC Insureds:

RISK ISSUE
Instituting a time-out process is known to increase patient safety by reducing wrong site, wrong procedure, wrong medication, and wrong patient errors. Compliance with the time-out process is essential to reduce human errors and system process gaps to ultimately eliminate preventable adverse events. The Joint Commission (TJC), World Health Organization (WHO), and OMIC all have developed surgical safety checklists that will assist you in implementing a systematic time-out process in your practice.

BACKGROUND
The Joint Commission (TJC) implemented the Universal Protocol in 2003 to reduce wrong events. The protocol has three elements: pre-procedure verification process, marking the procedure site, and time-out. The first two elements are important to ensure the time-out process is smooth. Pre-procedure verification includes confirming with the patient – BEFORE sedation – the patient’s name, the procedure to be performed, and site (left, right, bilateral). The marking of the site should be completed by the physician (or accountable licensed practitioner) with the patient’s participation. The time-out process should include every member of the procedural team. An individual on the team should be designated to lead the time-out. Everyone on the team should agree before proceeding and be encouraged to speak up if discrepancies are found.

The World Health Organization (WHO) developed a Surgical Checklist that also has three sections. The first, before induction of anesthesia, includes having the patient confirm their identity, site, procedure, and consent, and marking the site. In the second, before skin incision, the surgical team confirms the patient’s name, procedure, and site. As part of the third step, before the patient leaves the operating room, the team orally confirms the procedure performed.

OMIC and the American Academy of Ophthalmology formed a task force in 2012 to develop an ophthalmic-specific surgical safety checklist with the following three sections: sign-in (before anesthesia), time-out (before incision), and sign-out (before leaving the operating room). These checklists can be tailored to your specific practice based on your patient population, procedures performed, anesthesia administered, and procedure location. The time-out process is not time-consuming, but must be carried out thoroughly, with focus on each step, to help reduce or eliminate wrong events.

ASSESSMENT
Failing to institute a systematic, consistent time-out process in your practice can potentially lead to patient safety and liability exposures related to wrong site, wrong procedure, wrong medication, and wrong patient errors. Failure to use, or follow, timeout protocols and surgical checklists have resulted in OMIC claims against, and indemnity payments made on behalf of, insureds. TJC requires a comprehensive analysis of wrong-site surgeries in their accredited facilities. In a 2023 published study, they analyzed the contributing factors that led to these errors and found that 83.8% were due to failure to follow policy/protocol and 41.2% for failure to review the medical record. Performing a gap analysis in your facility, and developing risk mitigation strategies to fill those gaps can prevent an adverse event. Establishing evidence-based processes and creating a culture of safety will lead to improved patient safety and a reduction of liability exposure.

RISK RECOMMENDATIONS

Develop a surgical safety checklist, using the above resources as guides, which includes a time-out process to ensure correct patient, procedure, medication, and site.
Safety checklists should be used for procedures in the office and in the OR.
Train all staff in the elements of the surgical safety checklist.
Identify who will lead the time-out and consistently follow the process.
Empower the procedural staff to speak up if there are inconsistencies identified.
Audit compliance with your surgical safety checklist.

RESOURCES
OMIC Risk Management Recommendations- Time-Outs for Procedures
OMIC Surgical Checklist
OMIC Insured Time-Out Video
WHO Surgical Safety Checklist
TJC UP
AORN
ASCA

If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or call us at 1-800-562-6642 and enter 4 for Risk Management.

Sincerely,

Hans K. Bruhn, MHS
OMIC Risk Manager
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