Updated June 8, 2021 — As a larger segment of the U.S. population has become vaccinated, COVID-19 cases and deaths have substantially declined. According to the Centers for Disease Control and Prevention’s (CDC’s) Vaccine Data Tracker, roughly half of the U.S. population has had at least one dose of the COVID-19 vaccine, with around 41 percent being fully vaccinated (with vaccinated defined as being at least two weeks out from receiving a second dose of the two-part Moderna or Pfizer vaccine, or two weeks after Johnson & Johnson’s single-dose Janssen vaccine). For those over the age of 65, more than 85 percent have received one dose, while around 75 percent of that demographic have completed the series. Accordingly, on May 16, the CDC released new safety guidelines for individuals who have been fully vaccinated; however, medical practices should note that these recent changes do not apply to patients and staff within healthcare settings. Recommendations for use of personal protective equipment (PPE) by healthcare workers remain unchanged.
With some states fully reopening and COVID-19 mandates being lifted, what are the latest considerations for keeping patients and staff safe within the medical office setting? Here are some guidelines.
Managing the Unmasked
Some patients have refused to wear masks during the pandemic for various reasons, and now other patients may not understand that the CDC’s lifting of masking protocols for fully vaccinated patients does not apply to healthcare settings. The CDC’s language may have caused confusion, and the reference to healthcare settings was somewhat buried within their public announcement. Thus, when making appointments for in-office visits, practice staff should continue to set expectations prior to patients coming into the office regarding established infection control protocol. Patients should be informed that continued adherence with masking protocol is required. Patients also should be reminded that individuals in healthcare settings are often sick, immunocompromised, and in close proximity to one another, creating the potential for more exposure. Signage on the practice website, on the front door, and at the reception area will help alert patients that infection control protocols are still in effect. If the patient is uncooperative upon arrival, healthcare providers should ask the patient to step aside to a private area and acknowledge the patient’s concerns. If the patient is angry, they should be reminded that you are obligated to follow guidelines from the CDC as well as other government mandates, and that all infection control policies remain in place to ensure everyone’s safety. If the patient remains emotionally volatile and uncooperative, a healthcare provider can suggest the patient seek care with another healthcare provider. Per the CDC, cloth face coverings should not be used by those who are unable to remove the masks themselves, who have trouble breathing, or who are children under age 2.
Vital Pandemic Recordkeeping
Continue to maintain records of staff-patient contact, i.e., who was assigned to work with the patient, either in a log or in the electronic health record. Document so that you can track and notify contacts in case of a COVID-19 diagnosis or probable exposure on either the patient or provider side.
Further, to protect your practice, file records of staff screenings and screenings of those entering your facility in your administrative records, as well as maintaining records of all protocols and updated policies your office is following throughout this crisis. Keep records of PPE supplies/shortages, cleaning protocols followed, communications with patients, case incidence, and available medical resources within your community. Documentation that you have taken steps to follow recommended infection control protocol may be your best defense should COVID-19-related litigation occur in the future. For details, see COVID-19 Administrative and Medical Record Documentation: Prepare for Future Lawsuits.
Planning for a Vaccine
Vaccine Distribution
With vaccines now recommended for a broader population and more readily available within most communities (i.e., local pharmacies and grocery chains), practices should evaluate access to the vaccine for their patients and make plans to determine if and how they will handle administering a vaccine, should this be an option. Many medical practices are partnering with state and local governments to provide vaccine clinics within the community, particularly in rural areas.
Informed Decision Making
As the COVID-19 vaccine rollout continues across the United States, medical practices should implement plans to educate patients and guide them to an informed decision about the vaccines available within their community. Vaccine information sheets are available through the Food and Drug Administration (FDA) website: Pfizer-BioNTech—Fact Sheet for Recipients and Caregivers, Moderna—Fact Sheet for Recipients and Caregivers, and Janssen (Johnson & Johnson)—Fact Sheet for Recipients and Caregivers. The CDC also provides easy-to-understand fact sheets for patients on its website: Benefits of Getting a COVID-19 Vaccine and Myths and Facts about COVID-19 Vaccines. For additional information, see The Doctors Company Communicating With COVID-19 Vaccine-Hesitant Patients: Top Tips.
Vaccine Administration
Should your practice be designated as a vaccine administration site, policies and procedures should be established for storage and inventory, scheduling and patient screening, patient education, documentation and patient follow-up, and the management of medication errors and emergencies. If you are assigned a state-sponsored vaccination team to administer vaccines within your facility on your behalf, you should review their protocols to ensure practices are safe, and inform patients that the administration is being conducted by the state. The CDC provides guidance on vaccine storage and handling best practices, a training module for healthcare professionals, and reference material in training and education, as does the World Health Organization (WHO) through its online training. The FDA offers fact sheets (Pfizer-BioNTech, Moderna , Janssen) for healthcare providers administering the different vaccines under emergency use authorization and gives information on vaccine administration, safety, storage, informed consent, and reporting adverse events specific to the manufacturer’s vaccine. Other resources include the CDC’s Prevaccination Checklist for COVID-19 Vaccines (patient screening tool) and The Doctors Company’s FAQs About COVID-19 Vaccinations Reimbursement: See the Health Resources and Services Administration’s “What Providers Need to Know About COVID-19 Vaccine Fees and Reimbursements.”
Staying Diligent
The following recommendations will assist in the ongoing screening and management of suspected COVID-19 patients in your practice:
Legislation and Guidance
Reference the CDC, your state medical board, professional societies, and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation. Monitor for outbreaks of COVID-19 cases within your community. Stay on top of current trends to protect your patients and your practice.
Screening Criteria
Follow the CDC’s patient screening protocol for early disease detection for patients presenting to your practice. We recommend that you check the CDC website regularly for any updates in screening criteria. Essential visitors to your facility should also be assessed for symptoms and contact exposure and redirected to remain outside if it is suspected that they could have COVID-19.
Comparing COVID-19 and the Flu
Both the flu and COVID-19 are respiratory illnesses and can present in similar ways. For further guidance, see Flu or COVID-19? Convergence of Two Viruses Creates Risk of Diagnostic Errors.
Accepting Patients
It is strongly recommended that practices do not turn patients away who are not fully vaccinated or simply because a patient calls with acute respiratory symptoms. All patients should be triaged over the phone or via telemedicine and managed according to CDC recommendations. Refusing assessment/care may lead to concerns of patient abandonment.
Designated Triage Location
Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices. Community emergency preparedness plans have been activated so that parties are coordinating efforts to deliver effective public health intervention.
Telehealth Triage
The CDC recommends alternatives to face-to-face triage and visits, particularly for high-risk patients, if screening can take place over the phone, via telemedicine, through patient portals or online self-assessment tools, or through a designated external triage station. Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home versus those who need to be seen either at the office or at a designated community facility. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The CDC provides a Clinical Decision Algorithm to Guide Care Advice Messages, which includes a clinical decision-making tree. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center, as does the CDC in Using Telehealth to Expand Access to Essential Health Services During the COVID-19 Pandemic. For a list of telehealth COVID-19 rules by state, visit Federation of State Medical Boards: COVID-19.
Patient Testing
Physicians should determine which patients require testing based on presenting symptoms, history, contact exposure, community transmission of disease, and for early identification in special settings (e.g., nursing home admission or elective surgery). See the CDC’s COVID-19 Testing Overview and Overview of Testing for SARS-CoV-2 (COVID-19). The CDC advises, “Healthcare providers should immediately notify their local or state health department in the event of the identification of a PUI (Person Under Investigation) for COVID-19.” The CDC offers the Clinician Call Center, which is available to healthcare personnel to assist with diagnosis, clinical management, and infection control protocol. Dial (800) CDC-INFO [(800) 232-4636] and ask for the Clinician Call Center.
Elective Services
Should cases of COVID-19 trend upward within your community, check with regional health authorities on the provision of nonessential and elective healthcare visits and group-related activities. States and counties vary depending on number of cases, availability of PPE, and availability of hospital beds. For diagnostic and therapeutic interventions, including surgery, the CDC provides the Framework for Healthcare Systems Providing Non-COVID-19 Clinical Care During the COVID-19 Pandemic. Also, the American College of Surgeons (ACS) published Clinical Issues and Guidance on triage and management of surgical cases, including specialty guidelines. Some states may reinstate restrictions on the provision of nonurgent, elective surgeries and procedures. (See ACS: COVID-19: Executive Orders by State on Dental, Medical, and Surgical Procedures). In some states, violations may result in physician jail time, fines, or complaints to the medical board. Check with state and local regulatory agencies for any related mandates.
Office Messaging
Practices should post front-door signage requiring patients and visitors who are exhibiting COVID-19 symptoms or who have had contact exposure to immediately notify facility personnel via telephone for instructions on accessing care. Include information on the practice website regarding office policies for appointments, telephone assessment/telemedicine, and visitors. Also, post COVID-19 resources for patients (e.g., the CDC’s Coronavirus (COVID-19) page and COVID-19 Frequently Asked Questions) with a reminder to maintain physical distance, to wear a face mask, and to follow local orders to lessen community spread. If the office is closed, update voicemail messages to address telephone assessment, telemedicine, and how to reach the physician in the event of an emergency.
Physical Distancing
The CDC still recommends physical distancing within your facility; require that patients and staff sit at least six feet or more apart. Patients should be asked to wait in their car if that option is available. Reconfigure seating as needed. Remove magazines and toys from the waiting room. Routinely disinfect the waiting room throughout the day. Develop a cleaning schedule and checklist for your facility, and document in administrative files that it is followed.
Suspected Infection
Evaluate patients on a case-by-case basis. If presenting symptoms and/or contacts are suspicious for COVID-19, and it is determined that the patient must be seen, have the patient call prior to their arrival to make preparation for accommodation. When possible, conduct the patient evaluation outside your facility at a designated triage location. If that is not possible, immediately isolate the patient coming into the office (segregating them from other patients in the facility) in a designated regular exam room with dedicated patient care equipment. A back entrance should be utilized.
Patient Precaution
For individuals entering your facility, query all patients about symptoms of coronavirus and document findings on an administrative log. Instruct patients to put on a cloth mask, face mask, or respirator covering the nose and mouth (source control), utilize tissues, practice good hand hygiene, and physically distance from others in the designated waiting area. Educational resources, including posters and print resources for use in the medical office, are available from the CDC (Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings) and the WHO. Reference the CDC’s Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
Visitor Precautions
Allow only those visitors who are essential for the patient’s well-being and care to enter your healthcare facility, and require screening and source control cloth masks as indicated.
Provider/Staff Precautions
Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that follow the Occupational Safety and Health Administration’s (OSHA’s) Temporary Enforcement Guidance—Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies. Remember that patients will scrutinize your adherence to infection control protocol; ensure that staff follow it precisely. Failure to do so may result in medical board complaints, negative social media coverage, and the patient leaving the practice permanently. Provide updated staff training on infection control protocol as needed. See Updated Healthcare Infection Prevention and Control Recommendations in Response to COVID-19 Vaccination for more information.
Limit Exposure
Limit staff exposure to suspected COVID-19 patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
Surface Disinfection
Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE. For general guidance, see Clinical Questions About COVID-19: Questions and Answers. The CDC has updated guidelines for considerations on how long exam rooms should remain vacant between patients. Be mindful that according to the CDC and research published in the New England Journal of Medicine, it is unknown exactly how long the virus remains active once a room is vacated. Follow the CDC for updated guidance on how COVID-19 spreads: “It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes. This is not thought to be the main way the virus spreads . . .”
Patient Education
Provide up-to-date, factual information on the virus to suspected COVID-19 patients and their close contacts, including how to follow infection-control practices at home, such as in-home isolation, hand hygiene, cough etiquette, waste disposal, and the use of face masks. Remind patients and their families to access information about the virus through reputable sources such as the CDC, not social media.
Provider/Staff Exposure
Encourage vaccination among your staff. Screen healthcare personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed, monitored, and documented in administrative files. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance under the section “Infection Control” for management. Disclosure to patients may be necessary depending on the type of exposure that occurred, if any, but always take necessary steps to protect the privacy of the infected employee. Telephone calls directly to the patient are the most efficient method of notification, followed with a letter. Suggested notification may include “We are calling to inform you that someone in our office tested positive for COVID-19 on the day of your visit…” followed by recommendations for assessment and any needed follow-up. The health department may assist with patient notification if determined to be necessary. Contact your patient safety risk manager at The Doctors Company, as needed, for additional guidance. For return-to-work guidance, review the Return to Work Criteria.
Staff Training
Assess the need for additional staff training to review screening and triage protocols, patient management, use of PPE, patient communications, and any revision in policies and procedures that have been made to adapt to the evolution of the virus. Document all training provided to staff and maintain records in administrative files.
Team Brief
Conduct daily staff briefs/huddles and end-of-day debriefs. This provides all staff opportunities to discuss anticipated issues during the day and identify concerns, pre- and post-clinic, including COVID-19 updates. (See TeamSTEPPS Fundamentals.) Acknowledge the need to provide emotional support to staff who may be dealing with fear or other stressors through employee assistance programs or other support mechanisms. Communicate resources to employees.
Managing Legal Risks
Worldwide, COVID-19 has stricken more than 171.3 million, with global deaths reaching beyond 3.5 million. Within U.S. borders, more than 33 million Americans have been afflicted, with number of deaths surpassing 595,000. While actual case numbers are declining, the potential influx of variants in the U.S. will again present unique challenges. Government authorities in some states will mandate additional restrictions of public activities, while other states, conversely, will likely maintain unrestricted business operations. Medical offices will continue to face multiple challenges, including in-pandemic rules for operation, managing sick employees, and the provision of “catch-up” care for patients who had clinical services postponed while offices were closed, or who have put off contacting their physician because of fears.
The bottom line: even with the availability of the vaccine, medical practices must not let their guard down with complacency. Because this continues to be a moving target, physicians and all healthcare facilities must remain well-informed and current on public health guidance for screening protocols and patient management, as well as regulatory requirements impacting their practices. Continued careful screening with a bias for suspicion that a patient might have COVID-19 will serve healthcare providers well in this situation.
As we move forward, we emphasize that keeping office policies and procedures current while following recommended guidelines, with documentation of adherence in both administrative files and medical records, is key to litigation defense in the future.
The dynamics surrounding the virus will continue to evolve, particularly with the spread of variants and as the population is vaccinated. What must not change is that physicians and care teams should remain vigilant and adapt their practices accordingly. They should remain exceptionally proactive in asking the right questions, documenting interactions, rigorously following protocols, and keeping abreast of emerging insights and data as they become available from the CDC.
RESOURCES
The Doctors Company: COVID-19 Resource Center for Healthcare Professionals
The Doctors Company: FAQs About COVID-19 Vaccinations
The Doctors Company: Communicating With COVID-19 Vaccine-Hesitant Patients: Top Tips
American College of Physicians: COVID-19: An ACP Physician’s Guide + Resources (Last Updated May 28, 2021)
The Doctors Company: Flu or COVID-19? Convergence of Two Viruses Creates Risk of Diagnostic Errors
Equal Employment Opportunity Commission (EEOC): What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws
CDC: Healthcare Workers: Information on COVID-19
CDC: Clinical Questions About COVID-19: Questions and Answers
American Academy of Family Physicians (AAFP): Checklist to Prepare Physician Offices for COVID-19
The Doctors Company: Burnout During COVID-19: How Healthcare Professionals Can Manage Stress
ECRI: COVID-19 Resource Center
ACS: Be Prepared: Patient-Surgeon Discussion Guide
Johns Hopkins Global Case Map: COVID-19 Dashboard by the Center for Systems Science and Engineering
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
Reprinted with permission. ©2021 The Doctors Company (www.thedoctors.com).
