Patient COVID-19 Operations Process
By Nufactor - April 5, 2024

The Centers for Disease Control and Prevention (CDC) updated their recommendations for healthcare personnel on March 18, 2024 (Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) | CDC). This information applies to all U.S. settings where healthcare is delivered, which includes the home setting.

The major change is if COVID-19 is not suspected in a patient (based on symptom and exposure history), the healthcare provider should follow Standard Precautions. This means masking is not necessary in most situations. For the typical Nufactor^® patient in the home setting, following Standard Precautions is sufficient. Standard Precautions focuses on handwashing and donning gloves when it can be reasonably anticipated that contact with blood or other potentially infectious materials could occur (e.g., IV access, SC needle insertion). Following Standard Precautions does not require the patient and nurse to be away from other household members.

Standard Precautions allow use of additional personal protective equipment (PPE) appropriate to the task. For example, gowns are warranted to protect skin and prevent soiling or contamination of clothing during procedures and patient-care activities when contact with blood, body fluids, secretions, or excretions is anticipated. Mouth, nose, eye protection is warranted to protect the mucous membranes of the eyes, nose and mouth during procedures and patient-care activities that are likely to generate splashes or sprays of blood, body fluids, secretions and excretions. Encountering such scenarios in the Nufactor^® patient home setting are not likely.

Patient/family member screening for COVID-19 should continue and then appropriate steps taken. If COVID-positive, a COVID suspect (COVID symptoms without a confirmed test), or close contact (generally defined as being within 6 feet for at least 15 minutes cumulative over a 24-hour period), recommendations are to follow Transmission-Based Precautions and airborne precautions, which would require the use of N-95 masks and other PPE for the patient and nurse and isolating from others. Nufactor’s^® COVID-19 Pre-Visit Screen Tool can be found at the top of the Nufactor^® website at Nufactor.com.

Some other changes:

• For COVID-positive patients NOT moderately / severely immunocompromised, recommendations were different if mildly ill versus moderately ill. Recommendations are now the same for these two severity types.
• Previous recommendations for some patient types under specific circumstances required isolating/masking for 5 days, then masking for another 5 days. The specific 5-day isolation period has been removed. Isolating/masking is recommended for 10 – 20 days, depending on patient type and specific circumstance.
• Testing to end isolation/masking has changed.
• When applicable, changes have been incorporated in the Screen Tool.

The following is Nufactor’s^® protocol and reminders to help prevent infection during nursing visits. These guidelines can also be found at the top of the Nufactor^® website at COVID-19 Nursing Visit Guidance on Nufactor.com

1. The day before a visit, the nurse screens the patient for COVID-19.
2. The day before a visit, the nurse screens household members for COVID-19.
3. The day of visit, the nurse self-screens for COVID-19.
4. The day of the visit, before entering the home, the nurse asks if there have been changes since screening the day before.
5. Patient/household member without suspected COVID-19, without confirmed COVID-19 infection or not having been in close contact with someone (being within 6 feet for at least 15 minutes cumulative over a 24-hour period) with confirmed COVID-19:
1. Follow CDC Standard Precautions, including:
• Wear gloves when it can be reasonably anticipated that contact with blood (e.g., during venipuncture) or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin or contaminated equipment could occur.
2. Request gown/protective eyewear/mask if performing activities that could cause contact with blood, body fluids, secretions, or excretions.
6. Patient/household member with suspected, with confirmed COVID-19 infection or being in close contact with someone (being within 6 feet for at least 15 minutes cumulative over a 24-hour period) with confirmed COVID-19 in up to the past 20 days, and nurse agrees to visit:
1. Don PPE
• Nurse: N-95, eye protection/face shield, gloves, gown (Nufactor^® provides)
• Patient: N-95 (Nufactor^® provides)
2. When possible, establish only the patient in a separate area/room with a separate bathroom away from others.
3. If present, household members should wear CDC-recommended masks, which do NOT include bandanas, gaiters or buffs. (Nufactor^® does not provide)
4. When possible, during the visit, maintain distance of 6 feet (e.g., after starting an infusion, monitoring vital signs, etc.) but always stay in visual contact with the patient.
7. Patient requests for the nurse to don a surgical or N-95 mask under any circumstance will be honored.
8. Nurse requests for a surgical or N-95 for themselves under any circumstance will be honored.

COVID SEVERITY

• Mild: Includes fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell but who do not have shortness of breath, dyspnea, or abnormal chest imaging
• Moderate: Shows evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air at sea level.
• Severe (unlikely to be encountered in the home setting) Individuals who have SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, a respiratory rate >30 breaths/min, or lung infiltrates >50%.

MODERATE AND SEVERE IMMUNOCOMPROMISING CONDITIONS

Moderate and severe immunocompromising conditions and treatments include many seen in patients who receive immune globulin and monoclonal antibody therapies provided by Nufactor^®. The degree of immunocompromise for the patient is determined by the treating provider, and preventive actions should be tailored to each patient and situation. Conditions and treatments include, but are not limited to the following.

• Active treatment for solid tumor and hematologic malignancies.
• Receipt of solid-organ transplant and taking immunosuppressive therapy.
• Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy).
• Moderate or severe primary immunodeficiency (e.g., CVID, Selective Antibody Deficiency, Subclass Deficiency, SCID).
• Advanced HIV infection (people with HIV and CD4 cell counts less than 200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) or untreated HIV infection.
• Active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites (e.g., methotrexate, immunosuppressive drugs used for transplants/other reason (e.g., azathioprine/Imuran^®, cyclosporine, mycophenolate/CellCept^®, tacrolimus), cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers (e.g., infliximab / Inflectra^® / Remicade^® / Renflexis^®, Enbrel^®, Humira^®, Cimzia^®, and Simponi^®), and other biologic agents that are immunosuppressive or immunomodulatory.

References/Resources:

1. Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) | CDC dated 03/18/24
2. Isolation Precautions | Guidelines Library | Infection Control | CDC dated 07/11/23
3. Transmission Precautions | Appendix A | Isolation Precautions | Guidelines Library | Infection Control | CDC dated 11/05/15
4. Precautions | Appendix A | Isolation Precautions | Guidelines Library | Infection Control | CDC dated 07/22/19