Coronavirus-Resuming Elective Surgeries and Procedures

Coronavirus-Resuming Elective Surgeries and Procedures

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SUGGESTED APPROACH FOR RESUMING ELECTIVE SURGERIES AND PROCEDURES
May 18, 2020


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Working together and sharing information is essential to address the COVID-19 crisis. That’s why COPIC developed this document and is providing it as a resource to members of the health care community. As we move into a phase of resuming elective surgeries and procedures, there are several key guidelines that have been released and offer a roadmap for medical providers. COPIC’s physicians and attorneys have compiled the following information in a concise summary that can be customized for your needs. We hope you find value in this document and are proud to contribute as we move forward in the fight against COVID-19.
Gerald Zarlengo, MD, CEO of COPIC  

Important note: Orders, regulations, and guidelines from local public health agencies may be issued within the next few days on procedures to be used in resuming elective surgeries and procedures. All providers should pay close attention to what local agencies may issue and comply accordingly.

In addition to the information below, COPIC has developed webinar presentations that focus on returning to practice. These presentations can be accessed on our COVID-19 Webinars page.

There are three areas of preparation a health care system, hospital, facility, or provider group should consider in scheduling elective surgeries or procedures during the COVID-19 pandemic: 
1) Review the considerations contained in the resource links in this document to establish the background data and information they need to ensure that it is safe to proceed with elective surgeries or procedures during the pandemic;
2) Create a “What You Should Know About an Elective Surgery or Procedure During the COVID-19 Pandemic” patient education document that contains important information for the patient to know. This will be provided to the patient and can be readily amended as circumstances necessitate; and,
3) Utilize a “Special Consent Form for An Elective Surgery or Procedure During the COVID-19 Pandemic” (link to suggested COPIC-developed template is in the last section of this document), which would be in addition to the usual permit for the surgery or procedure, and would cross-reference the “What You Should Know…” document.  

Establish the Background and Data Necessary to Establish It Is Safe to Proceed with Elective Surgeries and Procedures: The resources listed in this section list several factors and data points that providers should analyze, consider, and retain for future use before proceeding with elective surgeries or procedures.  

Joint Statement: Roadmap for Resuming Elective Surgery After COVID-19 Pandemic: This is a collaborative statement issued by the American College of Surgeons, American Society of Anesthesiologists, Association of periOperative Registered Nurses, and the American Hospital Association. The general categories to consider, with detailed information contained in the statement, are: geographic location, sustained reduction in rate of new COVID-19 cases during the last 14 days, sufficient staff equipped to treat all elective patients, testing capacity for staff and patients, PPE, case prioritization, ability to manage non-COVID-19 patients through the 5 stages of surgical care, collection and management of data with ongoing assessments to re-evaluate policies and procedures, and consideration of a second wave of COVID-19 patients.
https://www.aha.org/system/files/media/file/2020/04/roadmap-from-aha-others-for-safely-resuming-elective-surgery-as-covid-19-curve-flattens.pdf 

• Opening Up America Again: CMS Recommendations on Re-Opening Facilities to Provide Non-Emergent Non-COVID-19 Health Care: Phase 1: This is a statement issued on April 19, 2020, by the Centers for Medicare and Medicaid to provide recommendations for “non-emergent, non-COVID-19 healthcare.” The gating criteria for phases 1 and 2 in the Opening Up America guidelines referenced below are relied upon. Decisions should be made in accordance with local public health departments and providers should consider if there are adequate facilities, adequate testing supplies, and an adequate workforce to provide all phases of care. In general, other considerations, with more detailed information provided in the statement, include: evaluation of COVID-19 incidence trends, evaluation of the clinical needs for the elective surgery or procedure, ability to establish “non-COVID care zones” distanced away from other patients as much as possible, adequate PPE, routine testing of the workforce and patients, visitors prohibited or pre-screened, effective sanitation, and ongoing data evaluation.
https://www.cms.gov/files/document/covid-flexibility-reopen-essential-non-covid-services.pdf 

• Opening Up America: Guidelines: These are general federal guidelines on what may be considered before moving forward with an activity in one of three phases. Phase 1 references that elective surgeries or procedures can resume as clinically appropriate on an outpatient basis at facilities that adhere to CMS guidelines. Phase 2 references outpatient and inpatient surgeries and procedures. The guidelines state that before entering into Phase 1, consideration be given to the downward trajectory of flu-like or COVID-19 symptoms reported within the last 14 days, the downward trajectory of COVID-19 cases within the last 14 days or the downward trajectory of positive tests as a percentage of total tests within the last 14-day period, and that hospitals are capable of treating all patients including those without crisis care and have robust testing procedures for at-risk health care workers. https://www.whitehouse.gov/openingamerica/#criteria

Create a Patient Education Communication On: “What You Should Know About an Elective Surgery or Procedure During the COVID-19 Pandemic” (or similar title): This is an informational piece developed by the health care system, hospital, facility, or practice group that contains information the patient should or would want to know. A common document will ensure that providers are giving the same information to patients as generally applied to elective surgeries and procedures, and this allows for amendments to the document as changing circumstances may dictate. This document should emphasize that an elective surgery or procedure does not need to be performed at this time and that there is a risk that the patient could be infected with COVID-19. Other information could include, but not be limited to: determination of surgery or procedure priorities, COVID-19 testing policies for patients and staff, COVID-19 counseling information, patient safety considerations, PPE use, patient family and visitor policies, post-discharge follow-up, advanced directives, and the potential for necessary resources being unavailable should the patient become infected. The document should be referenced in the Special Consent Form referenced in the next section. A helpful reference for the messaging of the communication is: “Local Resumption of Elective Surgery Guidance” published by the American College of Surgeons.  
https://www.facs.org/covid-19/clinical-guidance/resuming-elective-surgery 

Limited Recommencement of Voluntary or Elective Surgeries and Procedures in Colorado: Following the above-described Executive Order, CDPHE issued a Public Health Order (see link below) that sets forth priorities, including sufficient health care capacity and PPE to provide critical and emergency care, and the needed volume of community testing, before health care providers can start phasing in voluntary or elective surgeries and procedures. Prior to resuming surgeries and procedures, the setting in which they will be performed must comply with various criteria, such as maintaining a two-week supply of PPE without the need for affecting emergency PPE-conserving measures; implementing a universal symptom screening process; and, establishing a plan and guidelines to ensure compliance with the criteria. The Public Health Order further sets steps and criteria for hospitals to resume and maintain voluntary or elective surgeries and procedures, including access to adequate PPE, ventilators, medications, supplies, and medical staff; and, the consideration of postponement of voluntary or elective surgeries and procedures that are expected to require transfusion, pharmaceuticals or PPE in short supply, ICU admission, and transfer to a skilled nursing facility or inpatient rehab. The hospital or other surgical setting must develop a plan to reduce or cease voluntary or elective surgeries and procedures in the event of a COVID-19 resurgence in its region, and reassess their operations every two weeks for compliance with the plan, and that the protocols, criteria and best practices in the Executive Order and the Public Health Order are being prioritized. https://drive.google.com/file/d/1Z7mRvwd4ibpvEwkXir4rjubFkcIA1U3F/view

Utilize a “Special Consent Form for an Elective Surgery or Procedure During the COVID-19 Pandemic” (or similarly titled document): This special consent form would be used in addition to the standard consent form associated with the type of surgery or procedure. Using a special consent form emphasizes the important shared decision of agreeing to, and performing, an elective surgery or procedure. This form can concisely set forth the information and risks and is to be used in tandem with the patient education communication referenced previously. The form should reference the patient education communication and that the communication was, in fact, provided to the patient. Below is a link for a sample template for such a form. Please understand that COPIC provides this sample template only as a suggestion and it should not be considered as providing legal advice under any circumstances. Each provider should consider what information needs to be contained in their own Special Consent Form and patient education communication, then consult with a private attorney to review.   

Download a copy of the suggested sample consent template