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COVID-19 and Patient Safety in the Medical Office

Debbie Kane Hill, MBA, RN, Senior Patient Safety Risk Manager

Updated February 22, 2021: While recent news stories have reported a global decline in COVID-19 cases over the past few weeks, there is extreme concern about a potential surge of cases with the newly emerging variants from the United Kingdom, South Africa, and Brazil. Practices must safeguard their patients and staff members by preparing for possible new outbreaks in the United States, realizing that some states that were not strongly affected by the first and/or second waves of the virus may now be facing an influx of COVID-19 patients.

Follow the strategies below for this next season of the pandemic, including guidance for protective recordkeeping, maintaining documentation and follow-up for noncompliance and coordination of care, managing patients who resist infection-control measures or vaccination, and tracking ongoing guidance from health authorities.

Vital Pandemic Record Keeping

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 screenings of staff members and of those entering your facility in your administrative records, as well as all protocols and updated policies your office is following during 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 Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.

Managing Difficult Patients

Our country’s political environment has impacted perspectives on COVID-19, and many practices are experiencing patients who still believe the virus is a hoax and refuse to follow safety protocols. When making an appointment for in-office visits, set expectations prior to the patient coming into the office about established infection control protocol. If the patient is uncooperative upon arrival, ask the patient to step aside to a private area and acknowledge their position. Listen to the patient’s concerns and remain calm. If the patient is angry, do not lose your temper, and remind the patient you are obligated to follow guidelines from the Centers for Disease Control and Prevention (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, suggest the patient seek care with another healthcare provider.

Planning for a Vaccine—During Flu Season

  • Vaccine Distribution: While we are still in the early phases of vaccine rollout, practices should make plans now to determine if and how they will handle administering a vaccine, once more vaccines become available. For more information on vaccine rollout, see the COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, which provides guidance for states, territories, tribal governments, and local public health programs to operationalize the COVID-19 vaccination distribution. The Council of State Governments provides a list of State Vaccination Plans based upon the CDC’s COVID-19 Vaccination Program Operational Guidance.
  • Vaccine Administration: Should your practice be designated as a vaccine administration site, ensure you have policies and procedures for storage and inventory, scheduling and patient screening, documentation and patient follow-up, the continued use of PPE, and the management of medication errors. The CDC provides advice on best practices for vaccine administration in its COVID-19 Vaccine Training Modules, as does the World Health Organization through its online training. The Food and Drug Administration’s (FDA’s) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers)—one for the Pfizer vaccine, and one for the Moderna—also gives information on vaccine administration, safety, storage, informed consent, and reporting adverse events. See The Doctors Company’s FAQs About COVID-19 Vaccinations for additional information.
  • Considerations During Flu Season: Due to misdiagnosis and delays in testing, patients have been turned away with COVID-19. Such situations not only put the patients and others at risk, but also put healthcare providers and hospitals at risk for litigation. We recommend that when in doubt, healthcare providers should adopt a clinical suspicion of COVID-19 to protect the patient and others. In this regard, flu season poses special challenges. Both the flu and COVID-19 are respiratory illnesses and can present in similar ways, so providers should devote attention to differentiating COVID-specific symptoms, such as new loss of smell or taste. For further guidance, see Flu or COVID-19? Convergence of Two Viruses Creates Risk of Diagnostic Errors and Similarities and Differences between Flu and COVID-19.
  • Patient Education and Informed Consent: The physician’s job is not to sway the patient to get the vaccine, but to provide factual information so that the patient can make an informed decision. Provide written educational materials to patients in their preferred language (e.g., vaccine information sheets). Conduct and document a thorough informed consent discussion using language the patient can understand. Include information on the potential consequences of contracting the disease as a result of non-vaccination. See The Doctors Company article Communicating with COVID-19 Vaccine-Hesitant Patients: Top Tips. For patients who refuse the COVID-19 vaccine, consider the use of a Refusal to Consent to Treatment, Medication, or Testing form.

Staying Abreast of Changes

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 an increase in 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 assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). We recommend that you check this CDC website often for any updates in screening criteria. Essential visitors to your facility should also be assessed for symptoms of COVID-19 and contact exposure and redirected to remain outside if appropriate.
  • Accepting Patients: It is strongly recommended that practices do not turn patients away 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: With community spread and the resurgence of COVID-19 in some states, the CDC recommends alternatives to face-to-face triage and visits 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 Phone Advice Line Tools, which includes a sample phone script, a clinical decision-making algorithm, and advice messages. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center, as does the CDC: 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). When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s COVID-19 Testing Overviewand 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: Check with regional health authorities regarding the provision of nonessential and elective healthcare visits and group-related activities. State and county recommendations vary depending on number of cases, availability of personal protective equipment (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. Many states have reinstated 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 new office policies for appointments, telephone assessment/telemedicine, and visitors. Also, post COVID-19 resources for patients [e.g., the CDC / Federal Emergency Management Agency (FEMA) 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: To maintain physical distancing within your facility, require that patients and staff sit at least six feet 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, 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 Precautions: For individuals entering your facility, query all patients about symptoms of COVID-19, and document findings in an administrative log. Instruct patients to put on a face mask, utilize tissues, practice good hand hygiene, and to physically distance from others in the designated waiting area. Educational resources, including posters for use in the medical office, are available from the WHO and for healthcare workers from the CDC (Standard Precautions). Reference the CDC’s Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemicand Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
  • Provider/Staff Precautions: Follow Standard Precautionsand Transmission-Based Precautions, including gloves, gowns, protective eyewear, and use of National Institute for Occupational Safety and Health (NIOSH)-certified N95 respirators. 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 and the CDC’s Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings. 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/or the patient leaving the practice permanently. Provide updated staff training on infection control protocol as needed.
  • Limiting Exposure: Limit staff exposure to suspected 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 vacantbetween 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-positive 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: 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,” as does the American Dental Association: What to Do if Someone on Your Staff Tests Positive for COVID-19. 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 by mail. 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 Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
  • Staff Training: Assess the need for additional staff training to review screening and triage protocols, patient management, use of PPE, patient communications, and any revisions 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 Briefs: 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 Course and TeamSTEPPS® Teamwork Training in the Office Practice.)
  • 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, Staying Vigilant

Worldwide, COVID-19 has stricken more than 108 million, with global deaths reaching beyond 2.3 million. Within U.S. borders, more than 27 million Americans have been afflicted, with the number of deaths surpassing 476,000. While actual case numbers are declining, the 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 infection fears.

The bottom line: Medical practices must not let their guard down or succumb to complacency. Because guidelines continue 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 given that the spread of variants will be concurrent with the distribution of vaccines. 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.



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.

02/21

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