COVID-19: Current Questions and Risk Management Recommendations
September 8, 2021
Dear OMIC Insureds:
Risk Management continues to receive questions about COVID-related topics. Issues evolve as the virus does, presenting both clinical and administrative challenges to healthcare providers.
A good starting place is to think about the different scenarios you’re encountering and develop consistent, written policies and procedures. The goal is to keep patients and staff safe, let physicians focus on patient care, and minimize potential liability exposure.
Click here for our summary of frequently-asked questions and risk management guidance.
If you have questions, contact us for confidential risk management advice at riskmanagement@omic.com. Or call us at 1-800-562-6642, enter 4 for Risk Management.
Sincerely,
Jane Mock, CPHRM, OMIC Risk Manager
Take Time Out
August 9, 2021
Dear OMIC Insureds:
OMIC has received reports of “wrong” events associated with intravitreal injections. These include wrong condition, wrong dose, wrong drug, wrong eye, and wrong patient. To ensure that the correct drug and dose are injected into the correct eye every time, the ophthalmologist needs to lead a time out before each injection. A time out provides the opportunity to confirm that the patient, medical record, and ophthalmologist are in agreement.
In a 2-minute video, Dr. Pauline Merrill shares her tips for reducing the risk of error when administering intravitreal injections. You won’t want to miss this!
Click below to watch the video.
If you have questions, please contact OMIC Risk Management by calling 1-800-562-6642, enter 4 for the Risk Management group or email us at riskmanagement@omic.com.
Regards,
Michelle Pineda, MBA, OMIC Risk Manager
How effective is your missed appointment protocol?
June 8, 2021
Dear OMIC insureds,
Patients who fail to keep appointments disrupt their continuity of care and risk negative impacts to their health. These “no-shows” also have multiple costs for your practice, from lost revenue to additional time and frustration for you and your staff, as well as the lost opportunity to give that appointment to another patient. In our current climate of catching up on deferred care and postponed surgeries due to the pandemic, missed appointments have even greater impacts.
An effective missed appointment protocol actually begins far in advance of the appointment itself. Consider what method of communication you will use to remind patients of their appointments. Whether your system is manual, automated, or a hybrid, it should be customized to fit your patient population so it increases the probability of success. When patients register with your practice for the first time, or return for an appointment, take the opportunity to note if they prefer appointment reminders by text, email, or telephone. Keep the reminders brief and be clear about what action the patient needs to take to confirm or reschedule the appointment. These appointment reminders are also an opportunity to reinforce current safety precautions in your office.
When patients do miss appointments, it’s imperative that your staff understand what actions to take. Let them know what information you need in order to review no-shows and cancellations and determine next steps. This is a medical decision that cannot be delegated. On page 5 of our Noncompliance Toolkit we provide a sample strategy for managing missed appointments. When patients routinely miss appointments, they not only place their own health at risk, but they also increase your risk of a claim due to a missed or delayed diagnosis, or the effectiveness of ongoing treatment. In such instances you may need to consider discharging the patient from your practice, which is discussed in Terminating the Physician-Patient Relationship.
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,
Linda D. Harrison, PhD
Vice President, OMIC Risk Management
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.
Managing the Disruptive Patient
| November 6, 2020
Dear OMIC Insureds: Providing ophthalmic care that improves quality of life can lead to rewarding professional relationships with patients. However, the unfortunate reality is that ophthalmologists and their staff sometimes are confronted with angry, noncompliant, and even violent patients. You may be seeing an increase in such behaviors due to the stressors brought on by the pandemic and other societal events. Be aware that disruptive patients can become a distraction that leads to an increased risk of a claim. See the sample Policy and Procedure for the Disruptive or Dangerous Patient to educate and protect staff and others from patients who behave in a disruptive or threatening manner: https://www.omic.com/handling-the-disruptive-or-dangerous-patient/. If you elect to discharge a patient from your practice, use these guidelines and sample letters to help minimize the risk of patient harm and allegations of patient abandonment: https://www.omic.com/terminating-the-physician-patient-relationship/. If you have questions, contact us for confidential risk management advice by emailing us at riskmanagement@omic.com. Sincerely, Linda D. Harrison, PhD 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. |
Update: FDA formally requests recall of AmEx Pharmacy sterile products
UPDATE: FDA issues formal request to AmEx Pharmacy to recall sterile products. AmEx issues voluntary recall.
This is an update to OMIC’s earlier guidance on the FDA’s recommendation of a voluntary recall. The FDA has now issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. Here are excerpts from the August 27, 2019 FDA press release, which is available at https://www.fda.gov/news-events/press-announcements/fda-requests-recall-sterile-compounded-drug-products-produced-pacifico-national-inc-dba-amex.
AmEx issued the voluntary recall on August 30, 2019: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacifico-national-inc-dba-amex-pharmacy-issues-voluntary-nationwide-recall-all-lots-bevacizumab.
Excerpts from the FDA press release
“An FDA inspection of AmEx Pharmacy’s facility found conditions that could cause the company’s drugs to become contaminated or otherwise pose risks to patients. As a result, the agency recommended on June 25 that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy declined to initiate a recall of all unexpired drugs intended to be sterile and has not provided adequate assurances regarding the sterility and quality of its remaining and newly manufactured products.”
“Because of this, on August 27th, 2019, the agency issued a formal request to the outsourcing facility to recall all non-expired lots of drugs intended to be sterile. The FDA is also urging consumers to stop using these drugs and dispose of them immediately. Additionally, the agency is requesting the outsourcing facility cease production of drugs intended to be sterile until adequate remediation actions have been taken.”
“Health care professionals should immediately check their medical supplies, quarantine any drugs intended to be sterile and prepared by AmEx Pharmacy, and not administer or provide them to patients. The FDA urges health care professionals who obtained drugs from AmEx Pharmacy to make alternative arrangements to obtain medications from sources that adhere to proper quality standards.”
OMIC Risk Management Advice
- Follow the FDA advice:
- Quarantine all these drugs
- Do not administer them
- Obtain sterile drugs from another source
OMIC policyholders are encouraged to contact our confidential Risk Management Hotline if they need further assistance. Please call 800-562-6642 option 4 or email riskmanagement@omic.com.
