SYFOVRE™ (Pegcetacoplan) Consent
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May 9, 2023 Dear OMIC Insureds: We are pleased to announce the release of a consent form for FDA-approved SYFOVRE (Pegcetacoplan) treatment for Geographic Atrophy, a form of Dry Age-Related Macular Degeneration. 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, Michelle Pineda, MBA CONFIDENTIALITY NOTICE: This correspondence is intended only for the person or entity to which it is addressed and may contain information that is privileged, confidential or otherwise protected from disclosure. Dissemination, distribution or copying of this e-mail or the information herein by anyone other than the intended recipient, or an employee or agent responsible for delivering the message to the intended recipient, is prohibited. If you have received this e-mail in error, please notify us at riskmanagement@omic.com and destroy the original message and all copies. |
New and Updated Resources
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Informed Consent: Physicians and Facilities
March 7, 2023
Dear OMIC Insureds:
Insureds sometimes ask us about the difference between the surgeon’s duty to obtain informed consent, versus the ASC’s or hospital’s duty. Essentially, these are two distinct responsibilities required by both the surgeon and the facility.
The physician who will be performing the procedure must obtain the patient’s informed consent; this is not a delegable duty. The physician must explain the diagnosis and reasons for the proposed treatment, as well as the risks, benefits, alternatives, and consequences (if any) of no treatment. The physician must also assess the patient’s competence to make an informed decision and comprehension of the information. The discussion should be documented in the medical record; the signed, procedure-specific consent form should be maintained in the record, and a copy given to the patient.
The ASC or hospital verifies that the above discussion occurred. Facilities also obtain a general consent for care rendered at their facility.
To read more about this topic, refer to informed consent recommendations.
If you have questions about this topic or would like to have a confidential risk management consultation, please email riskmanagement@omic.com or call the Risk Management Hotline at 1-800-562-6642 and enter 4 for Risk Management.
Sincerely,
Linda D. Harrison, PhD
Vice President, Risk Management
Communicating with Patients by Email and Text
February 14, 2023
Dear OMIC Insureds:
Sending or receiving emails and text messages is commonplace, even preferred by many individuals. According to the Department of Health and Human Services, your practice is expected to use encrypted and secure systems to ensure confidentiality of protected health information (PHI).
Practices that fail to send PHI through a safe and secure platform run the risk of HIPAA violations and financial penalties. Although HIPAA violations for unsecure patient communications are relatively infrequent, violations can result in costly expenses.
OMIC Risk Management Recommendations:
Once health information is received in your office, it becomes PHI. All outgoing communications must be sent through an encrypted or secure system, unless the patient has been warned in writing, and accepts the risk. Consider updating the contact information preferences form for patients. The update should include the communication warning and their authorization signature.
Frequently asked questions:
1. What if a patient sends me an unsecure email or text message?
You should not assume you have consent to respond to unencrypted or unsecured text or email because your patient sent a message to you. If you receive a communication, warn the patient in writing of the risks of using an unsecure system and request authorization to continue communicating through an unsecure system.
2. Can you send texts and emails regarding patient care to other healthcare providers?
Yes, but only if the information is sent through an encrypted or a secure messaging system. Patient care documentation typically reports why the patient was seen, what assessment or treatment was provided, clinical findings (e.g., diagnoses), and what (if any) treatment was recommended.
3. Can I text physician’s orders to members of the health care team?
The purpose of the physician’s orders is to communicate the medical care that the patient is to receive while in the hospital as well as document the tests, medications, and treatments.
No, CME and the Joint Commission explicitly prohibit healthcare providers from texting orders. This prevents information being lost or compromised if it is manually entered into the medical records from a text message and ensures orders are in the medical records where all information for treatment decisions should be kept.
For more guidance on documentation, click on this link to OMIC’s risk management recommendations entitled, Documentation of Ophthalmic Care – OMIC.
If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or 1-800-562-6642, enter 4 for OMIC Risk Management.
Sincerely,
Hans K. Bruhn, MHS
OMIC Risk Manager
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Responding to Requests to Amend Medical Records
January 6, 2023
Dear OMIC Insureds:
The HIPAA Privacy Rule allows patients the right to request amendments to their medical record. Once the request is made the physician has the right to determine if the changes will be made and the response should be provided no later than 60 days from the receipt of the request. The medical record should contain the patient’s request to amend the record and the physician’s response.
A detailed description of the Amendment of Protected Health Information provides the necessary information to evaluate and respond in a timely manner.
If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com or 1-800-562-6642, enter 4 for OMIC Risk Management.
Sincerely,
Michelle Pineda
Michelle Pineda, MBA
OMIC Risk Manager
