COVID-19 Clinical Information
Modified on 5/6/2020 at 01:56pm

Patient care resources, including clinical and surgical processes, and COVID-19 information for UI Health Care clinicians.

We have developed this page in response to the COVID-19 outbreak in Iowa. This situation is rapidly evolving, and we will update this site as often as possible. Please contact Epidemiology (319-356-1606) with questions about the management of specific patients.

This site is provided for educational and informational purposes only and does not constitute providing medical advice or professional services. All information is meant for use by health care workers and not the general public. If you think you may have a medical emergency, call 911 or go to the nearest emergency room immediately. No physician-patient relationship is created by this web site or its use. Neither the University of Iowa nor its employees, nor any contributor to this web site, makes any representations or warranties, express or implied, with respect to the information provided herein or to its use.

Symptoms of COVID-19

Symptoms of COVID-19
Updated on 05/08/2020 at 8:07 am

For confirmed COVID-19 cases, reported illnesses have ranged from mild symptoms to severe illness.

According to the Centers for Disease Control and Prevention (CDC), frequently reported signs and symptoms include:

  • Fever (83–99%)
  • Cough (59–82%)
  • Fatigue (44-70%)
  • Anorexia (40-84%)
  • Shortness of breath (31-40%)
  • Sputum production (28-33%)
  • Myalgias (11–35%).

Sore throat has also been reported in some patients early in the clinical course.

Less commonly reported symptoms include: headache, confusion, rhinorrhea, sore throat, hemoptysis, vomiting, and diarrhea. Some patients have experienced gastrointestinal symptoms such as diarrhea and nausea prior to developing fever and lower respiratory tract signs and symptoms.

Anosmia or dysgeusia are frequently reported symptoms that are very unusual in non-COVID-19 viral illnesses.

Age is a strong risk factor for severe illness, complications, and death.  Heart disease, hypertension, prior stroke, diabetes, chronic lung disease, and chronic kidney disease have all been associated with increased illness severity and adverse outcomes.

The CDC believes at this time that symptoms of COVID-19 may appear in as few as 2 days or as long as 14 days after exposure.

COVID-19 treatment guide

COVID-19 therapeutic guidance
Updated on 03/10/2021 at 4:40 pm

University of Iowa Health Care

Guidance on Treatment Options for Patients with SARS-CoV-2

PROTOCOL TEMPORARILY CREATED PURSUANT TO AUTHORITY OF HOSPITAL INCIDENT COMMANDER ACTIVATED IN RESPONSE TO COVID-19. EFFECTIVE UNTIL FURTHER NOTICE.

Date Created Per HICS: 3/10/2020                       Date Amended: 03/01/2021

Remdesivir is the only FDA approved therapy for SARS-CoV-2, but other therapies are still being investigated. Clinical trial data is rapidly emerging and local and national guidelines addressing treatment options have been published and are frequently updated. UIHC Guidance on Treatment Options for Patients with SARS-CoV-2 will assist UIHC staff when making treatment decisions in patients with SARS-CoV-2 (COVID-19). These guidelines are meant to serve as guidance and are not intended to replace clinical judgement. There is a great deal of uncertainty around this evolving pandemic and information may change rapidly.

This document has been vetted by UIHC experts in the fields of infectious disease and adult and pediatric hematology and has been reviewed by the Pharmacy & Therapeutics Working Group, as well as Hospital Incident Command System.  Information will be updated as new information becomes available and can be subsequently evaluated. COVID-19 is an emerging, rapidly evolving situation. It is important to remember that data becomes available before it is peer reviewed, and that in the current COVID-19 pandemic environment, there are more recalls of “evidence” than we have seen in the past.

Key Points Regarding TREATMENT of Patients with COVID-19:

  • Standard of care for most patients continues to be appropriate isolation and support of organ systems based on the most recent guidance from the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Guidelines provided by the National Institutes of Health (NIH) recommend pharmacologic therapies in select patient groups with more severe disease.
  • There are numerous antiviral therapies being proposed as options for treatment of SARS-CoV-2. The use of any investigational therapy should preferentially be through enrollment in clinical trial.
  • This document provides a brief overview of therapeutic agents for use in COVID-19; it will be subject to updates and changes as additional information becomes available
  • In the case of lab-confirmed SARS-CoV-2, patients should be evaluated for eligibility in ongoing clinical trials in coordination with research teams. Patients who are ineligible or decline participation in clinical trial may remain candidates for therapeutic agents that have been granted approval or emergency use authorization (EUA) from the FDA.
  • Remdesivir for adults and pediatric patients ≥12 years old and weighing ≥40 kg is the only FDA approved therapeutic agent. Remdesivir for pediatric patients <12 years of age weighing at least 3.5 kg or patients weighing 3.5 kg to <40 kg remains subject to availability through EUA only. Institutional eligibility criteria remain in place for remdesivir (see additional details below)
  • Several agents are now available through emergency use authorization (EUA) including monoclonal antibodies and convalescent plasma; however, receipt of these therapies may disqualify patients for ongoing clinical trials.

Tier 1: medications with evidence of benefit in select patient groups from randomized clinical trials  

Medication Details
Steroids Clinical trial data show a benefit with steroid treatment in certain patients with COVID-19. A large adaptive and prospective study of 6425 adult patients in the United Kingdom randomized patients in 2:1 fashion to dexamethasone 6 mg daily for up to 10 days or usual care. Patients allocated to dexamethasone had a statistically significant improvement in the primary outcome of 28-day mortality (21.6% vs 24.6%, rate ratio 0.83 (95% CI 0.74-0.92, p-value <0.001). This mortality benefit was seen in patients who were receiving respiratory support at time of randomization (most pronounced with invasive mechanical ventilation) but not in patients not receiving respiratory support at time of randomization. Benefits of steroid administration have been additionally borne out in subsequent, smaller studies.

  • In adult patients, initiation of dexamethasone 6 mg daily for up to 10 days should be considered in hospitalized patients with COVID-19 requiring either invasive or non-invasive oxygen support. Dexamethasone for treatment of COVID-19 should be discontinued at time of discharge unless needed for other reasons.
  • In pediatric patients, steroid use may be considered on a case-by-case basis for patients hospitalized with concern for disease secondary to SARS-CoV-2 infection per the discretion of the treating team with the acknowledgement that there remains a paucity of data in this patient population.
Remdesivir
  • Nucleotide prodrug with in vitro activity against a variety of RNA viruses including coronaviruses.
  • Initiation of therapy by the primary treatment team requires fulfillment of the institutional eligibility criteria (see Appendix A)

Questions specific to initiation of remdesivir in patients under the age of 18 may be directed to pediatric infectious disease consult service

Baricitinib
  • Oral Janus kinase (JAK) inhibitor with selectivity for JAK1 and JAK2 that can prevent cellular immune activation and inflammation
  • Received an EUA for use in combination with remdesivir in treatment of hospitalized patients with COVID-19 who require supplemental oxygen
  • No data for use in combination with steroids and should ONLY be considered outside of clinical trials as an alternative in the setting of a significant contraindication to use of glucocorticoids. For additional details see Appendix B
  • There is an NIH sponsored clinical trial to compare the benefit of addition of dexamethasone versus baricitinib to remdesivir. This study is enrolling patients hospitalized COVID-19 patients requiring respiratory support but are not on mechanical ventilation at UIHC.

No data exists for use in treatment of pediatric patients with COVID-19 and considerations on risk and benefit profile needs to made on a case-by-case basis. Questions specific to initiation in pediatric patients under the age of 18 may be directed to pediatric infectious diseases consult service.

Convalescent Plasma
  • Plasma is available through FDA emergency use authorization for any hospitalized patient with confirmed or suspected COVID-19. Evidence of benefit is highest in patients who are treated with receive high titer convalescent plasma early in their disease course ( generally prior to requiring mechanical ventilation) or those hospitalized with impaired humoral immunity.
  • Patients being treated for COVID-19 more than 14 days since symptom onset should only receive plasma in the setting of a negative SARS-CoV-2 serology test. For additional details see Appendix C.
  • Special populations such as patients under the age of 18 years and patients who are pregnant or nursing should be evaluated for risk/benefit on a case-by-case basis as little is known about safety or efficacy.

Orders for convalescent plasma should preferentially be entered between the hours of 0900 and 1700 to ensure adequate screening for available clinical trials.

Tier 2: insufficient data to recommend use for or against outside the context of clinical trial

Medication Details
Monoclonal Antibodies
  • Monoclonal antibodies mimic proteins produced by the human body in response to a viral infection.
  • Two products are in advanced development and have emergency use authorizations from the FDA for outpatients with mild to moderate COVID-19 and not requiring oxygen (above baseline) and deemed to be high risk for progression to severe disease and/or hospitalization (see Appendix D for additional details).
    • Bamlanivimab (product of Eli Lilly)
    • Bamlanivimab and etesevimab (product of Eli Lilly)
    • Casirivimab and imdevimab (product of Regeneron)

 Tier 3: not recommended for treatment unless in the context of a clinical trial – theoretical benefit unproven and potentially outweighed by risks (in alphabetical order)

Medication Rationale for Recommendation
Azithromycin One piece of literature has proposed addition of azithromycin to hydroxychloroquine decreased time to viral clearance. No clinical outcomes were assessed and only 6 patients received azithromycin. There is not enough evidence to recommend this combination.
Darunavir / cobicistat There is no laboratory or clinical data to demonstrate potency against SARS-CoV-2
Famotidine Although there are observational data suggesting improved clinical outcomes in COVID-19 patients, guidance from agencies including the CDC, WHO, and IDSA do not include famotidine in treatment options recommended for use in patients with COVID-19.
Hydroxychloroquine / Chloroquine Though both chloroquine and hydroxychloroquine demonstrated potent in vitro inhibition of SARS-CoV-2, trial information available to date suggests no benefit in treatment of COVID-19 disease either as monotherapy or in combination with azithromycin. Restrictions on prescriptions remain in place to reserve drug primarily for rheumatologic indications.
Interferon Interferons have been studied (often in combination with ribavirin) in other coronaviruses but have been met with limited clinical success.
Influenza Agents Coronaviruses do not utilize neuraminidase for replication and no activity is expected.
Ivermectin Initial reports suggest that drug is unlikely to achieve adequate concentrations in humans for antiviral activity against SARS-CoV-2
Lopinavir / ritonavir Though there have been in vitro studies suggesting some level of activity against coronaviruses, RCT of 200 patients showed no benefit over placebo and an open label trial compared to a Japanese antiviral drug showed no association for better outcomes with lopinavir/ritonavir
Ribavirin Ribavirin has been studied (often in combination with interferon) in other coronaviruses including SARS-CoV-1 and MERS without clinical success. Side effects such as anemia are likely to outweigh the potential benefit

 Supportive Agents (in alphabetical order)

Medication Details
Acetaminophen / NSAIDs (non-steroidal anti-inflammatory drugs) There is no conclusive evidence to suggest that NSAIDs such as ibuprofen increase the severity of COVID-19 disease; however, acetaminophen may be considered the preferred fever-reducer / pain reliever in patients with viral illness based on more benign overall side effect profile
ACE-inhibitors / ARBs Theoretical concern has been described over the risk of ACE-inhibitors and ARBs increasing therapeutic targets for SARS-CoV-2. At this time, professional societies in cardiology and nephrology are advising not to add or remove any RAAS-related treatments beyond actions based on standard clinical practice.
Interleukin inhibitors (including anakinra, sarilumab, tocilizumab) There is no evidence to routinely recommend these agents for patients with COVID-19. Currently, tocilizumab is restricted to prescribing by Dr. Zuhair Ballas in the setting of cytokine storm associated with COVID-19. Additional guidance forthcoming regarding criteria for use of these agents in this patient population.
Intravenous Immunoglobulin (IVIG) Routine use not recommended by Society of Critical Care Medicine (SCCM); however, it may be considered in the context of cytokine storm (additional criteria forthcoming) or clinical trial.
Steroids See Tier 1 above
Venous Thromboembolism Prophylaxis & COVID-19-Associated Coagulopathy Adults: Thromboprophylaxis should be provided to all patients with COVID-19. See Appendix F for more information about prophylaxis in adult patients.

Pediatrics:  Consult Pediatric Hematology. See Appendix G for more information.

Pediatrics 12 years of age and older: thromboprophylaxis should be provided to all patients in this age group with COVID-19

Pediatrics less than 12 years of age: standard of care thromboprophylaxis for any hospitalized pediatric patient, which typically does not include chemoprophylaxis. For critically ill patients in this age group, strongly consider prophylactic anticoagulation.

 

Key Points Regarding PROPHYLAXIS of COVID-19:

  • There is no medication with definite efficacy in pre- or post-exposure prophylaxis in any patient population.

Appendix A: Remdesivir

Mechanism of Action: nucleotide analogue, initially developed for treatment of Ebola. It works by inhibiting RNA-dependent RNA polymerase.

Evidence Summary:  In-vitro activity against MERS and SARS and has shown efficacy in animal models. It inhibits SARS-CoV-2 in vitro. Clinical trial data out of China and published in The Lancet suggest a lack of robust benefit in patients with severe COVID-19. However, a clinical trial in the United States led by NIH showed a statistically significant reduction in time to clinical improvement in patients with severe COVID-19 treated with remdesivir compared to placebo. Detailed data from this study reveal that the benefit may be limited to a select group of hospitalized patients with disease requiring treatment with only low-flow oxygenation, but is underpowered for subgroup analysis. The study also showed a trend towards improved mortality, though this finding did not reach statistical significance. Additionally, a separate study suggests that shortened courses of 5 days is likely to be non-inferior to 10 days in certain patient populations.

It was approved by FDA on 10/22/2020 for remdesivir for adults and pediatric patients ≥12 years old and weighing ≥40 kg

Remdesivir for pediatric patients <12 years of age weighing at least 3.5 kg or patients weighing 3.5 kg to <40 kg is available through FDA emergency use authorization

Dosing:

  • Adults: 200mg IV x1, followed by 100mg IV daily x 4-9 days
  • Pediatrics: dosing is dependent on weight
    • ≥40 kg: 200 mg IV x1, followed by 100 mg IV daily x 4-9 days
    • 5 to 40 kg: 5 mg/kg IV x1, followed by 2.5 mg/kg IV daily x 4-9 days
  • Duration (regardless of age of patient)
    • 5-day total course for patients not requiring mechanical ventilation and/or ECMO
    • 10-day total course may be considered for patients requiring mechanical ventilation and/or ECMO
    • Therapy should be permanently discontinued if patients develops adverse effects or is discharged from the hospital prior to completion of 5-10 day course

Toxicity: elevated transaminases (reversible upon drug cessation), reversible kidney injury (avoid other nephrotoxic agents if possible, including NSAIDS), hypotension during infusion

Monitoring/labs: patients should minimally receive the below monitoring. Please direct questions on monitoring plan to the antimicrobial stewardship team or refer to the package insert or FDA fact sheet for healthcare providers.

  • Hepatic enzymes: ALT should be obtained at baseline prior to initiation and at least every other day while on therapy, particularly in those with elevations at baseline or deemed high risk for transaminitis. Therapy should be discontinued if ALT rises above 5-times the upper limit of normal
  • Serum creatinine: obtain at baseline prior to initiation and at least every other day while on therapy. Diminished creatinine clearance is not considered an absolute contraindication, but discontinuation may be considered at CrCl below 30 ml/min.

Drug metabolism: remdesivir is a prodrug requiring CYP3A4 for activation thus there is potential for reduced conversion in the presence of CYP3A4 inhibitors like lopinavir/ritonavir, cobicistat, etc.

IV compatibility: Is compatible with 0.9% NaCl, no other compatibility information is available

Administration/handling instructions: per prescription instructions and / or study team guidance. Dose is administered via IV infusion over 30-120 minutes.

 Routes of Access to Remdesivir at UIHC:  UIHC is acquiring the drug commercially at this time. If significant supply constraints occur, UIHC cannot and will not guarantee access to patients even if they appear to meet criteria as described below.

Key inclusion criteria:

  • Hospitalization
  • Confirmed SARS-CoV-2 by PCR
  • SpO2 ≤94% on room air OR requirement for supplemental oxygen above baseline
  • Weight ≥40 kg*
  • Age ≥12 years*

Key exclusion criteria:

  • ALT > 5x ULN
  • CrCL <30 ml/min
  • Symptom onset that is definitively greater than 10 days prior to planned initiation of therapy
  • Mechanical ventilation for ≥5 days at time of initiation of therapy
  • VV ECMO for ≥5 days at time of initiation of therapy
  • Any duration of VA ECMO

*Though the FDA-approved labeling only provides an indication for remdesivir in patients at least 12 years of age and 40 kg in weight, patients below these thresholds (as low as 3.5 kg in weight) may still receive remdesivir under the emergency use authorization. See corresponding pediatric Epic order and associated EUA fact sheets for additional information.

Appendix B: Baricitinib

Mechanism of Action:  inhibitor of Janus kinase which can interfere with the phosphorylation of signal transducer and activator of transcription proteins that are involved in vital cellular functions. It is theorized to potentially have additional direct antiviral activity through interference with viral endocytosis.

Evidence Summary:  baricitinib was studied in a multinational, randomized, placebo-controlled trial sponsored by NIH that included 1033 hospitalized patients with COVID-19 and evidence of pneumonia. The trial met its primary endpoint of time to recovery on an ordinal scale with the baricitinb group having a slightly shorter median time to recovery (7 days) vs the placebo group (8 days). The greatest benefit was found in the subgroup of patients that were on high-flow oxygen or noninvasive ventilation at the time of enrollment. There was no statistically significant mortality benefit observed.

Baricirinib received emergency use authorization from the FDA on 11/19/2020 for use in combination with remdesivir in hospitalized adults and children aged ≥2 years with COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Dosing:

  • Adults and pediatric patients 9 years of age and older: dosing is dependent on renal function
    • eGFR ≥60: 4 mg PO daily
    • eGFR 30-60: 2 mg PO daily
    • eGFR 15-30: 1 mg PO daily
    • eGFR <15: not recommended
  • Pediatric patients between 2 and 8 years of age: dosing is dependent on renal function
    • eGFR ≥60: 2 mg PO daily
    • eGFR 30-60: 1 mg PO daily
    • eGFR <30: not recommended
  • Duration (regardless of age of patient)
    • 14 days total treatment or until hospital discharge, whichever is first

Toxicity: baricitinib has been associated with several significant adverse effects including serious infections and thrombosis. Risk versus benefit should be assessed before initiating therapy.

Monitoring/labs: patients should minimally receive the below monitoring. Please direct questions on monitoring plan to the antimicrobial stewardship team or refer to the package insert or FDA fact sheet for healthcare providers.

  • Hepatic enzymes: ALT and AST should be obtained at baseline prior to initiation and at least every other day while on therapy, particularly in those with elevations at baseline or deemed high risk for transaminitis.
  • Serum creatinine: obtain at baseline prior to initiation and at least every other day while on therapy. Dose adjustments may be required based on renal function.
  • Complete blood count: obtain at baseline and at least every other day while on therapy. Consideration for discontinuation should be made at low absolute lymphocyte count (ALC less than 200) and/or absolute neutrophil count (ANC less than 500)

Drug metabolism: baricitinib has elements of both hepatic and renal metabolism. There are renal dose adjustments noted above, but no clear guidance in patients with severe hepatic impairment. There are dose adjustments recommended for patients on co-administered OAT3 inhibitors such as probenecid.

Administration/handling instructions: baricitinib tablets are given orally once daily with or without food. For patients who are unable to swallow whole tablets, alternative administration may be considered in the form of oral dispersion or administration via gastrostomy tube or nasogastric tube.

Restriction Criteria for Use in COVID-19: UIHC is able to acquire baricitinib through traditional commercial distribution due to indications for other disease states. Based on limitations of data particularly in comparison against steroids, use of baricitinib in COVID-19 is limited to the below criteria.

Key inclusion criteria:

  • Hospitalization
  • Confirmed SARS-CoV-2 by PCR
  • Requirement for supplemental oxygen above baseline
  • Age ≥2 years
  • Contraindication to use of glucocorticoids (i.e. dexamethasone)

Key exclusion criteria:

  • eGFR <15 (<30 if less than 9 years of age)
  • Absolute lymphocyte count less than 200
  • Absolute neutrophil count less than 500
  • Known active tuberculosis infection

Patients MUST receive the EUA fact sheet prior to initiation of therapy.

Appendix C: Convalescent Plasma (CCP) (investigational blood product)

Mechanism of Action: Antibody development in plasma of patients recovered from COVID-19 is used for passive transfer to treat individuals currently ill with COVID-19. This plasma is to be given to individuals with COVID-19 to try to help eliminate virus from the system and recover.

Evidence Summary:  The method of CCP has been used at various times for previous infections. There has been some evidence of benefit with Ebola, polio, measles, and influenza. Small case series with prior SARS and MERS demonstrated safety and faster viral clearance after administration of CCP, particularly when given early in the disease course.

The National Expanded Access Treatment Protocol sponsored by the Mayo Clinic published preliminary data on 35,322 patients who received product through the program. Though this was not a randomized, controlled trial the authors cited potential signals of efficacy. These signals included reduced mortality correlated with both earlier time to transfusions and receipt of transfusion with high antibody levels.

A prospective randomized controlled trial of 228 patients hospitalized with severe COVID-19 in Argentina demonstrated no benefit in terms of clinical status at 30 days after intervention or mortality. The median time from the onset of symptoms to enrollment in the trial was 8 days. However, a study of 160 patients (all at least 75 years old with at least one risk factor for progression to severe disease) treated with high-titer plasma within 72 hours of initial symptom onset demonstrated a reduction in progression to severe disease compared to placebo.

The available data suggest that use of COVID-19 convalescent plasma with high antibody titer may be effective in treating hospitalized patients with COVID-19 when administered early in the course of disease or when administered to patients with impaired humoral immunity. Early in the course of disease generally means prior to respiratory failure requiring intubation and mechanical ventilation. Limited clinical evidence suggests the potential therapeutic window following symptom onset may be longer in patients with suppressed or deficient humoral immunity.

On 8/23/2020, the FDA announced emergency use authorization to permit the use of COVID-19 CCP to treat hospitalized patients with COVID-19.  FDA do not provide specific guidelines for the use of CCP beyond this but specifically state that CCP is NOT the new standard of care and the EUA emphasizes that we should continue other clinical trials for COVID-19

Hospitalized patients with confirmed or suspected COVID-19 infection may receive COVID-19 CCP at UIHC. Time elapsed since initial symptom onset may be considered when assessing patients for CCP. People who have had symptoms for 14 days or less may be more likely to benefit. For patients beyond 14 days since symptom onset, serology testing may be performed. If serology testing is negative, patient may still be considered for CCP.

Teams should strongly consider patient eligibility for COVID-19 clinical trials prior to administration of CCP as receipt of plasma may disqualify patients from enrollment. Orders should preferentially be entered between 0900 and 1700 to ensure adequate time for clinical trial screening. Patients or caregivers must receive FDA fact sheet prior to administration or as early as practicable if delivery will delay administration to a degree that would endanger patient life.

Special populations such as patients under the age of 18 years and patients who are pregnancy or nursing should be evaluated for risk/benefit on a case-by-case benefit as little is known about safety or efficacy.

Dosing:  Standard dose is 1-2 units with each unit transfused over 1-4 hours. Patients at risk for volume overload (impaired cardiac or renal function, positive fluid balance) should receive one unit over 4 hours and a second unit given the next day if desired.

Toxicity: similar risks with any plasma infusion, allergic reaction and viral infections

Monitoring/labs: type and screen needed on file prior to dispensing of blood product

Administration/handling instructions: per order instructions. Each unit may be transfused over 2-4 hours.

Appendix D: Monoclonal antibodies targeting SARS-CoV-2 spike protein (investigational drugs)

Two investigational products are in advanced development with similar mechanisms of action and criteria for emergency authorization for use. With limited availability of clinical data and drug supply, UIHC is making these treatments available only to qualifying outpatients meeting both the criteria set forth in the EUA and our institution (see table below).

For information regarding workflow processes related to monoclonal antibody therapy, see separate documents within the “COVID-19 Clinical Information” on the Loop.

  1. Bamlanivimab (product of Eli Lilly)
    • Mechanism of action: neutralizing IgG1 monoclonal antibody that binds to the receptor-binding domain of the spike protein of SARS-CoV-2.
    • Evidence summary:
      • Neutralizing antibodies have been shown to play an important role in the body’s defense against a variety of pathogens including viral infections. Analysis of antibodies generated using both humanized mice and convalescent patients revealed several promising molecules; however, human studies of this monoclonal antibody remain ongoing.
      • Bamlanivimab is being studied in a randomized, double-blind, placebo-controlled, phase 2 dose-finding study known as the BLAZE-1 study. In this study, patients were randomized to placebo or one of three doses of bamlanizimab (700 mg, 2800 mg, or 7000 mg) within 3 days of a positive SARS-CoV-2 test. The primary outcome assessed was change in viral load from baseline to day 11 along with several secondary outcomes including rate of COVID-19-related hospitalization and visits the Emergency Department. A pre-planned interim analysis revealed no significant finding in the primary outcome and a relatively flat dose-response relationship; however, it noted a reduction in hospitalizations in the treatment groups compared to placebo (6% in placebo, 1% in 700 mg arm, 2% in both 2800 and 7000 mg arms).
    • Based on the results of this interim analysis, the FDA granted emergency use authorization for bamlanivimab on 11/09/2020 for use in patients with mild to moderate COVID-19 disease not on supplemental oxygen (above baseline) and deemed to be high risk for progression (see table below for FDA criteria for use). National guidelines including those published by NIH and IDSA continue to emphasize that this treatment does NOT represent a new standard of care.
    • Due to limitations in drug availability and preliminary status of the clinical trial data, UIHC is only able to offer this investigational therapy to select adult patients. Patients meeting the EUA criteria AND who fall into an adequately high risk stratification category will be contacted and offered the opportunity to receive a one-time infusion after careful discussion of the potential risks and benefits.
    • EUA fact sheets for bamlanivizumab are available on The Loop and must be provided to patient and / or caregiver prior to drug infusion.
    • Dosing: 700 mg intravenous infusion once over 16-60 minutes
    • Toxicity / adverse effects: most frequently reported adverse events were nausea and diarrhea. Hypersensitivity and infusion-related reactions are possible and have been reported in small numbers in the ongoing, blinded trials. There remains limited clinical trial data available so serious and unexpected adverse effects MAY occur that have not been previously reported.
  1. Bamlanivimab and etesevimab (product of Eli Lilly)
    • Mechanism of action: the two antibodies in this therapy are recombinant neutralizing human IgG1k monoclonal antibodies that bind to different but overlapping epitopes in the receptor-binding domain of the Spike protein of the SARS-CoV-2 virus which should reduce risk of viral resistance compared to single agent.
    • Evidence summary:
      • Neutralizing antibodies have been shown to play an important role in the body’s defense against a variety of pathogens including viral infections. An analysis of antibodies generated using both humanized mice and convalescent patients revealed several promising molecules but human studies of this monoclonal antibody are still in progress.
      • Bamlanivimab and etesevimab monoclonal antibody cocktail is being studied in the BLAZE trials investigating the safety and efficacy of bamlanivimab and etesevimab together for treatment of patients with COVID-19. In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying bamlanivimab 2800 mg plus etesevimab 2800 mg versus placebo. The primary outcome measure for the Phase 3 portion was the percentage of participants who experience COVID-related hospitalizations or death from any cause by Day 29 and preliminary analysis of 1035 patients suggests a 70% risk reduction in patients taking therapy compared to patients taking placebo. Adverse events were fairly limited among the clinical trial participants.
    • Based on the results of this analysis, the FDA granted emergency use authorization for bamlanivimab and etesevimab on 2/9/2021 for use in patients with mild to moderate COVID-19 disease not on supplemental oxygen (above baseline) and deemed to be high risk for progression (see table below for FDA criteria for use). National guidelines including those published by NIH and IDSA continue to emphasize that this treatment does NOT represent a new standard of care.
    • Due to limitations in drug availability and preliminary status of the clinical trial data, UIHC is only able to offer this investigational therapy in select adult patients. Pending drug availability, patients meeting the EUA criteria AND who fall into an adequately high stratification category will be contacted and offered the opportunity to receive a one-time infusion after careful discussion of the potential risks and benefits.
    • Dosing: 700 mg bamlanivimab and 1400 mg of etesevimab administered together as a single intravenous (IV) infusion over 21-70 minutes
    • Toxicity / adverse effects: most frequently reported adverse events were nausea and diarrhea. Hypersensitivity and infusion-related reactions are possible and have been reported in small numbers in the ongoing, blinded trials. There remains limited clinical trial data available so serious and unexpected adverse effects MAY occur that have not been previously reported.
  1. Casirivimab and imdevimab (product of Regeneron)
    • Mechanism of action: the two antibodies in this therapy bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment
    • Evidence summary:
      • Neutralizing antibodies have been shown to play an important role in the body’s defense against a variety of pathogens including viral infections. An analysis of antibodies generated using both humanized mice and convalescent patients revealed several promising molecules but human studies of this monoclonal antibody are still in progress.
      • Casirivimab and imdevimab monoclonal antibody cocktail is being studied in a Phase 1/2, randomized, double-blinded, placebo-controlled clinical trial in which adult outpatients with mild to moderate COVID-19 are enrolled 1:1:1 to receive either placebo, 2400 mg dose (1200 mg of each antibody), or 8000 mg (4000 mg of each antibody). The trial is designed to evaluate the primary endpoint of time to weighted average (TWA) changed from baseline in viral load as measured by PCR nasopharyngeal swab. Notable secondary endpoints include medically attended visits (MAVs) related to COVID-19 (comprised of hospitalizations, emergency room visits, urgent care visits, or physician office/telemedicine visits for COVID-19) and time to clinical improvement. Analysis of the data for 799 patients is available in the EUA fact sheet. TWA through day 7 was noted to be lower for the pooled doses of patients receiving treatment (-0.36 log10 copies / mL, p<0.0001). A lower proportion of patients in the treatment arms experienced MVAs compared to placebo arm (2.8% vs 6.5%) and median time to improvement was slightly lower in treatment arms vs placebo (5 days vs 6 days).
    • Based on the results of this analysis, the FDA granted emergency use authorization for casirivimab and imdevimab on 11/21/2020 for use in patients with mild to moderate COVID-19 disease not on supplemental oxygen (above baseline) and deemed to be high risk for progression (see table below for FDA criteria for use). National guidelines including those published by NIH and IDSA continue to emphasize that this treatment does NOT represent a new standard of care.
    • Due to limitations in drug availability and preliminary status of the clinical trial data, UIHC is only able to offer this investigational therapy to select adult patients. Pending drug availability, patients meeting the EUA criteria AND who fall into an adequately high risk stratification category will be contacted and offered the opportunity to receive a one-time infusion after careful discussion of the potential risks and benefits.
    • Dosing: 1200 mg of casirivimab and 1200 mg of imdevimab administered together as a single IV infusion over 60 minutes
    • Toxicity / Adverse effects: most frequently reported adverse events were nausea and diarrhea. Hypersensitivity and infusion-related reactions are possible and have been reported in small numbers in the ongoing, blinded trials. There remains limited clinical trial data available so serious and unexpected adverse effects MAY occur that have not been previously reported.

UIHC Criteria for Use of Bamlanivimab or Bamlanivimab/Etesevimab or Casirivimab/Imdevimab:

  UIHC Institutional Criteria for Use

 

FDA Criteria for Use per Emergency Use Authorization
Adult patients 18 years and older Patient must fulfill at least one of the criteria outlined in the EUA (see column to the right) PLUS they must score high enough on the COVID-19 risk stratification score to qualify. See “COVID Risk Score Criteria and Stratification” section under “Home Monitoring of COVID-19 positive patients” on the COVID-19 Clinical Information Loop page.  The stratification score that qualifies for monoclonal antibody therapy may change as drug supply and case counts go up and down.
  • Patient with mild to moderate COVID-19
  • Positive results of COVID-19 test
  • Within 10 days of symptom onset at time of infusion
  • High risk for progression to severe disease and/or hospitalization as defined by one or of the following:
    • BMI ≥35
    • Chronic kidney disease
    • Diabetes
    • Immunosuppressive disease
    • Immunosuppressive treatment
    • Age ≥65 years
    • Age ≥55 years PLUS one or more of the below:
      • Cardiovascular disease
      • Hypertension
      • Chronic respiratory disease
Pediatric patients 12 to 17 years of age Monoclonal antibody therapy for pediatric patients under the age of the 18 is not being recommended at UIHC at this time based on lack of published results with patients under age 18 and limited availability of drug.
  • Patient with mild to moderate COVID-19
  • Positive results of COVID-19 test
  • High risk for progression to severe disease and/or hospitalization as defined by one or more of the following:
    • BMI ≥85th percentile for their age and gender based on CDC growth charts
    • Sickle cell disease
    • Congenital or acquired heart disease
    • Neurodevelopmental disorders
    • Medical-related technological dependence
    • Reactive or other chronic respiratory disease
Pediatric patients under 12 years of age Do not qualify for monoclonal antibody therapy based on lack of indication listed in FDA emergency use authorization
  • Do not qualify

Appendix E: References for COVID-19 Therapeutic Treatment Options

Alhazzani, Waleed, et al. “Surviving sepsis campaign: guidelines on the management of critically ill adults with coronavirus disease 2019 (COVID-19).” Critical Care Medicine Journal (2020): 1-101.

American College of Cardiology. “HFSA/ACC/AHA statement addresses concerns re: using RAAS antagonists in COVID-19.” 2020.

—. “Ventricular arrhythmia risk due to hydroxychloroquine-azithromycin treatment for COVID-19.” Cardiology Magazine (2020): 1-9.

Arabi, Yaseen M, et al. “Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-B1b (MIRACLE trial) study protocol for a randomized controlled trial.” Trials (2018): 1-13.

Baden, Lindsey R and Eric J Rubin. “Covid-19 – The search for effective therapy.” New England Journal of Medicine (2020): 1-2.

Barnard, Dale L, et al. “Evaluation of immunomodulators, interferons and known in vitro SARS-CoV inhibitors for inhibition of SARS-CoV replication in BALB/c mice.” Antiviral Chemistry and Chemotherapy (2006): 275-284.

Beigel, J H, et al. “Remdesivir for the Treatment of COVID-19 – Final Report.” New England Journal of Medicine (2020): 1-14.

—. “Remdesivir for the treatment of COVID-19 – preliminary report.” New England Journal of Medicine (2020): 1-12.

Bhimraj, Adarsh, et al. “Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19.” (2020): 1-63.

Boulware, D R, et al. “A randomized trial of hydroxychloroquine as postexposure prophylaxis for COVID-19.” New England Journal of Medicine (2020): 1-9.

Cai, Qingxian, et al. “Experimental treatment with favipiravir for COVID-19: an open-label control study.” Engineering (2020): 1-13.

Cao, B, et al. “A trial of lopinavir-ritonavir in adults hospitalized with severe covid-19.” New England Journal of Medicine (2020): 1-13.

Cevik, Muge, Connor Bamford and Antonia Ho. “COVID-19 pandemic – a focused review for clinicians.” Clinical Microbiology and Infection (2020).

Chan, Jasper Fuk-Woo, et al. “Treatment with lopinavir/ritonavir or interferon-b1b improves outcome of MERS-CoV infection in a nonhuman primate model of common marmoset.” Journal of Infectious Disease (2015): 1904-1913.

Chen, F, et al. “In vitro susceptibility of 10 clinical isolates of SARS coronavirus to selected antiviral compounds.” Journal of Clinica Virology (2004): 69-75.

Chen, Jun, et al. “A pilot study of hydroxychloroquine in treatment of patients with common coronavirus disease-19 (COVID-19).” Journal of Zhejiant University (2020): 1-6.

Chen, Rong-chang, et al. “Treatment of severe acute respiratory syndrome with glucosteroids: the Guangzhou experience.” Critical Care Medicine (2006): 1441-1452.

Chu, C M, et al. “Role of lopinavir/ritonavir in the treatment of SARS: initial virological and clinical findings.” Thorax (2004): 252-256.

Cohen, Jordana B, et al. “Continuation versus discontinuation of renin-angiotensin system inhibitors in patinets admitted to hospital with COVID-19: a prospoective, randomized, open-label trial.” Lancet (2021): 1-10.

Colson, Philippe, et al. “Chloroquine and hydroxychloroquine as available weapons to fight COVID-19.” International Journal of Antimicrobial Agents (2020): 41-43.

Cortegiani, Andrea, et al. “A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19.” Journal of Critical Care (2020): 1-5.

Day, Michael. “Covid-19: ibuprofen should not be used for managing symptoms, say doctors and scientists.” 2020.

de Wilde, Adriaan H, et al. “Screening of an FDA-apporved compound library identifies four small-molecule inhibitors of Middle East Respiratory Syndrome Coronavirus replication in cell culture.” Antimicrobial Agents and Chemotherapy (2014): 4874-4884.

Dolin, Raphael and Martin S Hirsch. “Remdesivir – an important first step.” New England Journal of Medicine (2020): 1-2.

Gautret, Philippe, et al. “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial.” International Journal of Antimicrobial Agents (2020): 1-24.

Giudicessi, John R, et al. “Urgent guidance for navigating and circumventing the QTc prolonging and toradogenic potential of possible pharmacotherapies for COVID-19.” Mayo Clinic Proceedings (2020): 1-20.

Goldman, Jason D, et al. “Remdesivir for 5 or 10 days in patients with severe COVID-19.” New England Journal of Medicine (2020): 1-11.

Guastalegname, Maurizio and Alfredo Vallone. “Could chloroquine / hydroxychloroquine be harmful in Coronavirus Disease 2019 (COVID-19) treatment? .” Clinical Infectious Diseases (2020): 1-6.

Hansen, Johanna, et al. “Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail.” Science (2020): 1-9.

Horby, Peter, et al. “Effect of Dexamethasone in Hospitalized Patients with COVID-19 – Preliminary Report.” June 2020.

Joyner, Michael. “Expanded access to convalescent plasma for the treatment of patients with COVID-19.” Mayo Clinic IRB. 3 April 2020.

Joyner, Michael J, et al. “Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19: Initial Three-Month Experience.” (2020): 1-31.

Kalil, A C, et al. “Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.” New England Journal of Medicine (2020): 1-13.

—. “Baricitinib plus Remdesivir for Hospitalized Adults with COVID-19.” New England Journal of Medicine (2020): 1-13.

Keyaerts, Els, et al. “In vitro inhibition of severe acute respiratory syndrome coronavirus by chloroquine.” Biochemistry and Biophysics Research Communication (2004): 264-268.

Lee, Daniel W, et al. “Current concepts in the diagnosis and management of cytokine release syndrome.” Blood (2014): 188-195.

Libster, R, et al. “Early High-Titer Plasma Therapy to Prevent Severe COVID-19 in Older Adults.” New England Journal of Medicine (2020): 1-9.

Mahevas, Matthieu, et al. “No evidence of clinical efficacy of hydroxychloroquine in patients hospitalized for COVID-19 infection and requiring oxygen: results of a study using routinely collected data to emulate a target trial.” 2020.

Mehra, Mandeep R, et al. “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.” Lancet (2020): 1-10.

Mohammad, Samya, et al. “Examination of hydroxychloroquine use and hemolytic anemia in G6PDH-deficient patients.” Arthritis Care and Research (2018): 481-485.

Naitonal Institutes of Health. “NIH COVID-19 Treatment Guidelines: Remdesivir.” 24 July 2020. NIH. 30 July 2020.

Oldender, Susan A, et al. “Remdesivir for Severe COVID-19 versus a Cohort Receiving Standard of Care.” Clinical Infectious Diseases (2020).

Omrani, Ali S, et al. “Ribavirin and interferon alfa-2a foer severe Middle East respiratory syndrome coronavirus infection: a retrospective cohort study.” Lancet Infectious Disease (2014): 1090-1095.

Regeneron Pharmaceuticals. “Regeneron and Sanofi begin global Kevzara (saralimab) clinical trial progrm in patients with severe covid-19.” 16 March 2020. Regeneron. 19 March 2020. <https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-begin-global-kevzarar-sarilumab-clinical>.

—. Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-Flow Oxygen. Tarrytown, NJ: PRNewswire, 2020.

Russell, Clark D, Jonathan E Milar and J Kenneth Baillie. “Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury.” The Lancet (2020): 473-475.

Sanders, James M, et al. “Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19).” JAMA (2020).

—. “Pharmacologic treatments for coronavirus disease 2019 (COVID-19): A Review.” JAMA (2020): 1-13.

Sheahan, Timothy P, et al. “Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses.” Science and Translational Medicine (2017): 1-19.

—. “Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV.” Nautre Communications (2020): 1-14.

The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group. “Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients with COVID-19 A Meta-Analysis.” JAMA (2020): 1-12.

The Writing Committee for the REMAP-CAP Investigators. “Effect of Hydrocortisone on Mortality and Organ Support in Patients with Severe COVID-19.” JAMA (2020): 1-13.

Tomazini, Bruno M, et al. “Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients with Moderate or Severe Acute Respiratory Acute Respiratory Distress Syndrome and COVID-19.” JAMA (2020): 1-10.

US Centers for Disease Control and Prevention. “Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19).” 7 March 2020. US Centers for Disease Control and Prevention. 18 March 2020.

US Food and Drug Administration. “Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Bamlanivimab.” 11 November 2020. FDA. 23 November 2020.

—. “Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Casirivimab and Imdevimab .” 21 November 2020. FDA. 23 November 2020.

—. “Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of COVID-19 Convalescent Plasma for Treatment of COVID-19 in Hospitalized Patients.” 23 August 2020.

Vincent, Martin J, et al. “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread.” Virology Journal (2005): 1-10.

Wang, Manli, et al. “Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro.” Nature (2020): 269-271.

Wang, Yeming, et al. “Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.” The Lacnet (2020).

Warren, Travis K, et al. “Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys.” Nature (2016): 381-399.

World Health Organization. “Clinical management of severe actute respiratory infection (SARI) when COVID-19 disease is suspected: interim guidance.” 13 March 2020. World Health Organization. 17 March 2020.

Wu, Zunyou and Jennifer M McGoogan. “Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China.” JAMA (2020): 1-4.

Xu, Xiaoling, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Anhui, China: First Affiliated Hospital of University of Science and Technology of China, 2020.

Yamamoto, Norio, et al. “HIV protease inhibitor nefinavir inhibits replication of SARS-associated coronavirus.” Biochemical and Biophysical Research Communications (2004): 719-725.

Yao, Xueting, et al. “In vitro antiviral activity and projection and optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).” Clinical Infectious Disease (2020): 1-25.

Young, Barnaby Edward, et al. “Epidemiologic features and clinical course of patents infected with SARS-CoV-2 in Singapore.” JAMA (2020): 1-8.

Yuen, K Y, et al. “Role of lopinavir/ritonavir in the treatment of SARS: intitial virological and clinical findings.” Thorax (2004): 252-256.

Zhang, Haibo, et al. “Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target.” Intensive Care Medicine (2020): 1-5.

Zhao, Ming. “Cytokine storm and immunomodulatory therapy in COVID-19: role of chloroquine and anti-IL-6 monoclonal antibodies.” International Journal of Antimicrobial Agents (2020).

Appendix F: COVID-19-Associated Coagulopathy in Adults

The pathophysiology of COVID-19-associated coagulopathy appears to be complex and multifactorial, involving both cellular and plasmatic elements of the hemostatic system. Development of coagulopathy has been suggested to be a predictor of mortality in patients with COVID-19. Treatment with low-molecular weight heparin (LMWH) in prophylactic doses was associated with better outcomes in severe cases of COVID-19 meeting ISTH criteria for DIC in a retrospective analysis.

Laboratory Monitoring for COVID-19-Associated Coagulopathy:

Presentation at UIHC Non-ICU COVID-19 Decompensation or in ICU
CBC with differential

D-dimer

PT

PTT

Fibrinogen

 

Daily:

CBC with differential

D-dimer

 

Every other day monitoring:

Fibrinogen

Daily:

CBC with differential

D-dimer

PT

PTT

Fibrinogen

 Management:

All patients admitted to UIHC for COVID-19 should receive standard prophylactic anticoagulation with enoxaparin in the absence of any contraindications, see Table 1 for recommendations. Extending VTE prophylaxis for patients with COVID-19 is not necessary and should follow standard practice (a multidisciplinary discussion should occur at or near the time of discharge to determine if a patient has ongoing risk factors, may benefit form extended post-hospital VTE prophylaxis). Whether or not COVID-19-infected patients have a unique increased risk of VTE compared to other critical infections or processes is not currently known. At this time, we do not suggest intermediate or therapeutic doses of anticoagulation or thrombolytics for thromboprophylaxis. However, patients may be evaluated to participate in a clinical trial comparing standard prophylactic dose vs. intermediate-dose enoxaparin (see below for more information).

If patients with COVID-19 are admitted and have been receiving therapeutic anticoagulation (with direct acting oral anticoagulant or warfarin) prior to admission due to an appropriate indication (e.g., atrial fibrillation, prosthetic valve, h/o VTE, etc.) or if they require treatment with therapeutic anticoagulation due to an acute DVT/PE, therapeutic anticoagulation during admission should be carried out using therapeutic-dose enoxaparin per standard of care (preferred over UFH in order to minimize blood draws). If enoxaparin is contraindicated in a patient and heparin continuous infusion must be used, see table 2 for recommendations on monitoring.

Imaging:

Concern for DVT:

  • For patients with suspected DVT and elevated D-dimer, obtain lower extremity venous studies to evaluate asymmetric limb pain or edema. If DVT is present, start therapeutic dose anticoagulation (enoxaparin preferred).
  • If D-dimer is normal, but provider feels strongly that a lower extremity venous studies should be done, contact the vascular staff on call.
  • If patient has a known PE, do not order lower extremity venous studies, patient should already be receiving therapeutic dose anticoagulation (enoxaparin preferred).
  • If patient is already receiving therapeutic dose anticoagulation, lower extremity venous studies will not be performed.
  • No “follow-up DVT” lower extremity venous studies will be performed without discussion with vascular staff on call.
  • If patient is unable to get lower extremity venous studies due to concern of staff exposure to Covid-19, and clinical suspicion for DVT is high, consult Hematology attending.

Concern for Pulmonary Embolism (PE):

  • Consider PE and diagnostic CTA in the case of:
    • Acute worsening of hemodynamic or respiratory status including:
      • Acute worsening of oxygenation
      • Fluctuating blood pressure
      • Tachycardia with imaging findings not consistent with worsening Covid-19 pneumonia
      • Hemoptysis
      • Certain ECG signs [right heart strain, sinus tachycardia, simultaneous T wave inversions in the inferior (II, III, aVF) and right precordial leads (V1-4)]
  • Diagnostic evaluation:
    • Preferred: CTA
    • Alternative: ECHO may be useful if patient is unstable, CTA is unavailable, or when there are contraindications for CTA
  • Comments:
    • Elevated D-dimer is a hallmark of Covid-19 disease and higher levels have been associated with worse outcomes in Covid-19 disease. Therefore, elevated, marked increase, or rising D-dimer may not be useful in calculating pre-test probabilities scores in PE, as we these values cannot differentiate between worsening Covid-19 disease and developing PE.
    • Lower extremity venous studies should not be considered a routine part of an evaluation for suspected PE in patients with Covid-19.

 Clinical Trial Enrollment: Adult patients with confirmed SARS-CoV-2 may be eligible to participate in a study evaluating standard-dose vs. intermediate dose enoxaparin. Contact Usha Perepu (6-2195 or pager 3227) for more information.

Key Inclusion Criteria
  • Laboratory confirmed SARS-CoV-2 infection
  • Age ≥ 18 years
  • Requires hospital admission for further clinical management
  • Modified ISTH Overt DIC score ≥ 3 or ICU patient (irrespective of the score)
Key Exclusion Criteria
  • < 18 years old
  • Not admitted to hospital
  • Pregnancy
  • Indication for full therapeutic-dose anticoagulation
  • Acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months
  • Acute cardiovascular event within prior 3 months
  • Acute stroke (ischemic or hemorrhagic) within prior 3 months
  • Active major bleeding
  • Severe thrombocytopenia (<25,000/mm3)
  • Increased risk of bleeding, as assessed by the investigator
  • Acute or chronic renal insufficiency with estimated Creatinine Clearance< 30 ml/min calculated by the modified Cockcroft and Gault formula
  • Weight < 40 kg
  • Known allergies to ingredients contained in enoxaparin or allergy to heparin products such as history of heparin induced thrombocytopenia.
Intervention Patients will be randomized to receive intermediate dose enoxaparin (1 mg/kg SQ daily if BMI < 30 kg/m2 or 0.5 mg/kg SQ twice daily if BMI ≥ 30 kg/m2) or standard prophylactic dose enoxaparin.

Table 1: Thromboprophylaxis Recommendations in Adult Patients with COVID-19

Patient Type Non-ICU ICU
 

CrCl < 30 mL/min

Weight < 50 kg Preferred: UFH 5000 units SQ q12hr
BMI < 30 kg/m2  

Preferred: Enoxaparin 30 mg SQ daily

 

Alternative: UFH 5000 units SQ q12hr or q8hr

Preferred: Enoxaparin 30 mg SQ daily

 

Alternative: UFH 5000 units SQ q12hr or q8hr

BMI ≥ 30 kg/m2 but < 40 kg/m2

 

Preferred: Enoxaparin 30 mg SQ daily

 

Alternative: UFH 5000 units SQ q8hr

 

Preferred: Enoxaparin 30 mg SQ daily

 

Alternative: UFH 5000 SQ q8hr

 

BMI ≥ 40 kg/m2      or

Patient has additional risk factors*

 

Preferred: UFH 7500 units q8hr

 

CrCl ≥ 30 mL/min Weight < 50 kg Preferred: Enoxaparin 30 mg q24hr

Alternative: UFH 5000 units SQ q12hr

BMI < 30 kg/m2  

Preferred: Enoxaparin 40 mg SQ daily

 

Alternative: UFH 5000 units SQ q12hr or q8hr

 

Preferred: Enoxaparin 40 mg SQ daily

 

Alternative: UFH 5000 units SQ q12hr or q8hr

BMI ≥ 30 kg/m2 but < 40 kg/m2

 

 

Preferred: Enoxaparin 30 mg SQ q12hr

 

Alternative: UFH 5000 units SQ q8hr

 

 

Preferred: Enoxaparin 40 mg SQ q12hr

 

Alternative: UFH 5000 SQ q8hr

BMI ≥ 40 kg/m2        or

Patient has additional risk factors*

Preferred: Enoxaparin 40 mg SQ q12hr

 

Alternative: UFH 7500 units SQ q8hr

History of HIT Fondaparinux dose SQ q12hr

 

Dosing:

CrCl > 50 mL/min: 2.5 mg

CrCl 30 to 50 mL/min: 1.25 mg

CrCl < 30 mL/min: Consult Hematology

Fondaparinux dose SQ q12hr

 

Dosing:

CrCl > 50 mL/min: 2.5 mg

CrCl 30 to 50 mL/min: 1.25 mg

CrCl < 30 mL/min: Consult Hematology

(continued on next page)

Table 1: Thromboprophylaxis Recommendations in Adult Patients with COVID-19 (continued)

 

Pregnant Patient

All pregnant women admitted with confirmed or suspected COVID-19 should be given prophylaxis, unless birth is expected within 12 to 24 hours, there is active bleeding, or patient has a condition that places her at risk for significant bleeding  (e.g. placenta previa, placenta accreta spectrum)

 

Preferred: Enoxaparin (dose based on patient weight)

BMI ≤ 40 kg/m2:   Enoxaparin 40 mg SQ daily

BMI > 40 kg/m2:  Enoxaparin 40 mg SQ q12h

 

Alternative: UFH (recommended if CrCl < 30 mL/min/1.73 m2)

1st Trimester: 5000 to 7500 units SQ q12h

2nd Trimester: 7500 to 10000 units SQ q12h

3rd Trimester: 10000 units SQ q12h

 

The Maternal-Fetal Medicine (High Risk Obstetrics) physician on service/on call may be contacted if there are questions about VTE prophylaxis for pregnant or postpartum women.   The Family Medicine OB Service (pager 9024)  may be contacted if there are questions about VTE prophylaxis for pregnant or postpartum women who are cared for by their service.

 

Contraindications to Anticoagulation¥

 

Mechanical prophylaxis & Consult Hematology

HIT = heparin-induced thrombocytopenia

UFH: unfractionated heparin

* Risk Factors: surgery, burn injury, cancer, spinal cord injury, trauma

¥ Contraindications to anticoagulation: actively bleeding or platelet count < 25,000/mm3

Table 2: Recommendations for Monitoring Heparin Continuous Infusions in Patients with COVID-19

Scenario Yes No
aPTT prolonged at baseline* Use anti-Xa (consult Pharmacy for goal range and adjustment parameters) Use aPTT
Heparin resistance¥ Use anti-Xa (consult Pharmacy for goal range and adjustment parameters) Use aPTT

* Consider reasons other than COVID-19 infection for baseline aPTT prolongation as this laboratory finding could be due to an underlying coagulopathy that increases the risk of anticoagulant-associated bleeding.

¥ Heparin resistance: >35,000 units of heparin administered per 24 hours

References for COVID-19 Associated Coagulopathy:

American Society of Hematology Covid-19 Resources. Accessed April 20, 2020.

Anticoagulation Forum Webinar: Thrombosis in the Hospitalized COVID Positive Patient – April 16, 2020

Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 Pandemic: Interim Clinical Guidance from the Anticoagulation Forum. J Thromb Thromblysis. 2020 May 7. doi: xxx. [Epub ahead of print]

Casey K, Iteen A, Nicolini R, Auten J. COVID-19 pneumnia with hemoptysis: Acute segmental pulmonary emboli associated with novel coronavirus infection. Am J Emerg Med. 2020 Apr 8. doi: 10.1016/j.ajem.2020.04.011 [Epub ahead of print]

Co I, Eilbert W, Chiganos T. New electrocardiographic changes in patients diagnosed with pulmonary embolism. J Emerg Med. 2017;52:280-5.

Connors JM, Levy JH. COVID-19 and its implications for thrombosis and anticoagulation. Blood. 2020 Apr 27. pii: blood.2020006000. doi: 10.1182/blood.2020006000. [Epub ahead of print].

Guan WJ, Ni ZY, Hu Y, et al. China Medical Treatment Expert Group for Covid-19. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032

Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395: 497-506.

Klok FA, Kruip MJHA, van der Meer NJM, et al. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Apr 10  doi: 10.1016/j.thromres.2020.04.013 [Epub ahead of print]

Lee SG, Fralick M, Sholzberg M. Coagulopathy associated with COVID-19. CMAJ 2020. doi: 10.1503/cmaj.200685; early-released May 1, 2020.

Lippi G, Plebani M, Henry BM. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020;506:145-8.

Middeldorp S, Coppens M, van Haaps TF, et al. Incidence of venous thromboembolism in hospitalized patients with COVID-19. Preprints 2020, 2020040345 (doi: 10.20944/preprints202004.0345.v1).

Poissy J, Goutay J, Caplan M, et al. Pulmonary embolism in COVID-19 patients: Awareness of an increased prevalence. Circulation. 2020 Apr 24. doi: 10.1161/CIRCULATIONAHA.120.047430. [Epub ahead of print]

Tang N, Bai H, Chen X, et al. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020;18:1094–1099

Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020;18(4):844-7.

Thachil J, Tang, N, Gando S et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. JTH. March 27, 2020. 10.

Thomson D, Kourounis G, Trenear R, et al. ECG in suspected pulmonary embolism. Postgrad Med J. 2019;95(1119):12-7.

Wada H, Thachil J, Di Nisio M, et al. Guidance for diagnosis and treatment of DIC from harmonization of the recommendations from three guidelines. The Scientific Standardization Committee on DIC of the International Society on Thrombosis Haemostasis. J Thromb Haemost. 2013 Feb 4. doi: 10.1111/jth.12155.

Yin S, Huang M, Li D, Tang N. Difference of coagulation features between severe pneumonia induced by SARS-CoV2 and non-SARS-CoV2. J Thromb Thrombolysis. 2020 Apr 3 : 1–4. doi: 10.1007/s11239-020-02105-8 [Epub ahead of print]

Zhou, Ting Yu, Ronghui Du et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054-62.

Appendix G: Pediatric Considerations for Treatment of COVID-19

  • Most of the data generated to date regarding disease course and treatment of COVID-19 has come from studies that either exclusively or primarily focused on adult patients.
  • Epidemiologic studies suggest that children have a significantly different typical disease course than adults, with substantially fewer pediatric patients manifesting symptoms of severe disease and a significantly lower mortality rate.
  • While some FDA approvals and emergency use authorizations have included select pediatric patient groups, it is important to acknowledge the limitations of our knowledge around applications of these agents in these age ranges particularly since many of the clinical trials that led to emergency use authorizations did NOT include pediatric patient groups.
  • Consideration for utilization of therapeutic agents for COVID-19 in pediatric patients should involve assessment of potential benefits and risks on a patient-specific basis. Consultation with pediatric infectious disease service may be considered to help clarify potential risks and benefits.
  • Below is a summary of key pediatric-specific considerations for therapeutic agents that have received either emergency use authorization or full FDA approval for treatment of COVID-19 (plus corticosteroids). This information should not be interpreted as an endorsement of use of these agents, but rather serves as a reference. Order is taken from tiers that are outlined above (most theoretical benefit to least).
  • For additional information on any of these agents see separate appendices
Agent Comments Adult Dosing Pediatric Dosing#
Steroids
  • Dexamethasone remains the steroid with the most robust evidence in COVID-19
  • Limited pediatric enrollment in the RECOVERY trial in the UK but overall showed mortality benefit in patients requiring supplemental oxygen
Dexamethasone 6 mg IV/PO daily for up to 10 days or discharge from hospital, whichever occurs first Patients under 40 kg: Dexamethasone 0.15 mg/kg IV/PO daily for up to 10 days or discharge from hospital, whichever occurs first
Remdesivir
  • Only FDA-approved treatment option for COVID-19 in children down to 12 years of age and at least 40 kg
  • Shown to reduce time to clinical improvement in select adult patients but no trial has shown mortality benefit or clinical benefit in children
  • Use in any patient requires fulfillment of restriction criteria

·       Use in patients under 12 years of age or those less than 40 kg requires discussion of FDA fact sheet

200 mg IV loading dose followed by 100 mg daily x 4-9 days Patients under 40 kg: 5 mg/kg loading dose followed by 2.5 mg/kg daily x 4-9 days
Baricitinib
  • Received EUA for use in combination with remdesivir down to 2 years of age but there is no clinical data in pediatric patients for COVID-19
  • Showed reduced time to clinical improvement but no mortality benefit
  • Should only be considered when there is a compelling contraindication to use of steroids
4 mg PO once daily for up to 14 days or until discharge Patients 2-8 years of age: 2 mg PO once daily for up to 14 days or until discharge
Convalescent Plasma
  • Available through EUA for any hospitalized patient with confirmed or suspected COVID-19 but is restricted at UIHC (see criteria for use above)
  • Limited dosing information particularly for pediatric patients
Typically 1-2 units No data
Monoclonal antibodies
  • Both bamlanivimab and the combination product casirivimab and imdevimab have received EUA for outpatients down to age 12 years with mild-moderate COVID-19 who are high risk for severe disease / hospitalization
  • Full results of the ongoing clinical trials are not available but very few patients under age 18 have been enrolled
  • Monoclonal antibody therapies are currently being reserved at UIHC for select adult outpatients
Bamlanivimab 700 mg IV once

 

Casirivimab and imdevimab  2400 mg (1200 mg casirivimab plus 1200 mg imdevimab) IV once

No data for children under 12 years of age

#Default maximum dose in the adult dose

Appendix H: COVID-19-Associated Coagulopathy in Pediatrics

Consult Pediatric Hematology for hospitalized pediatric patients with symptoms of COVID-19 and a positive COVID-19 test. 

Despite the growing number of reported cases there remains a knowledge gap regarding the infectious, epidemiologic and clinical features associated with COVID-19 illness in children. Signs and symptoms of COVID-19 in children can range from asymptomatic to acute upper respiratory tract infection as well as gastrointestinal symptoms, respiratory failure, shock, coagulation dysfunction and renal injury in severe cases. The pathophysiology of COVID-19-associated coagulopathy in pediatrics it not yet well understood; hence, these patients require additional laboratory monitoring as recommended in Table 1.

Table 1: Lab Monitoring for hospitalized pediatric patients with symptoms of COVID-19 and a positive COVID-19 test: 

Admission at UIHC Non-ICU Covid-19 Decompensation or in ICU
CBC with differential

D-dimer

PT

PTT

Fibrinogen

Extra blue top (sodium citrate) tube

If patient is already having labs drawn, then draw these 2 labs daily with the other labs:

CBC with differential

D-dimer

 

If patient has clinical deterioration, then adjust labs to include these DAILY:

CBC with differential

D-dimer

Fibrinogen

Extra blue top (sodium citrate) tube

Daily:

CBC with differential

D-dimer

PT

PTT

Fibrinogen

Extra blue top (sodium citrate) tube

Pediatric patients 12 years of age or older  who are hospitalized with symptoms of COVID-19 and have a positive COVID-19 test should receive standard prophylactic anticoagulation with enoxaparin (see Table 2 for recommendations) in the absence of any known contraindications to anticoagulation (i.e., actively bleeding or platelet count < 25,000/mm3). If patient has a contraindication, the physician must determine risk vs. benefit to determine what is best for the patient.

Pediatric patients younger than 12 years of age a who are hospitalized with symptoms of COVID-19 and have a positive COVID-19 test should be evaluated for risk of thrombosis and provided thromboprophylaxis per standard of care, which typically does not include chemoprophylaxis.

Table 2: Thromboprophylaxis Recommendations for Pediatric Patients who are hospitalized with symptoms of COVID-19 and have a Positive COVID-19 test:

Patient Age  
 

 

12 years and older

Enoxaparin 0.5 mg/kg SQ q12hr (maximum dose 60 mg SQ q12hr)

Monitor anti-Xa levels as recommended in the University of Iowa Stead Family Children’s Hospital Anticoagulation Medication Guidelines

 

If CrCl < 30 mL/min/1.73m2:

Enoxaparin* 0.25 mg/kg SQ q12hr

 

Less than 12 years Evaluate for risk of thrombosis and provide thromboprophylaxis per standard of care, if applicable.
Pharmacist Collaborative Practice Protocol: Azithromycin Discontinuation Protocol

PROTOCOL TEMPORARILY CREATED PURSUANT TO AUTHORITY OF HOSPITAL INCIDENT COMMANDER ACTIVATED IN RESPONSE TO COVID-19. EFFECTIVE UNTIL FURTHER NOTICE.

Date Created Per HICS:       4/2/2020                                        Date Amended Per HICS:

University of Iowa Hospitals & Clinics (UIHC)

Pharmacist Collaborative Practice Protocol

Azithromycin Discontinuation Protocol

I.  Purpose & Goals

Purpose

  • The purpose of this protocol is to limit azithromycin durations of treatment in the setting of pneumonia

Goals

  • To optimize medication management of azithromycin for patients with pneumonia.
  • To improve adherence to prescribed treatment

II.  Providers Authorized

  • Providers working within UIHC who prescribe azithromycin for pneumonia are included in this protocol.
  • Pharmacists working within UIHC may provide care to patients pursuant to this

III.   Responsibilities Authorized by this Protocol

Pharmacist Scope of Practice

  • Medication Therapy Management:
    • Acute care pharmacists may discontinue azithromycin per protocol once a patient being treated for pneumonia has received a cumulative azithromycin dose of 1500 mg in adults or 30 mg/kg (up to 1500 mg) in pediatric patients (this includes cumulation of all intravenous and oral doses).
    • This excludes patients being treated for pneumonia or pulmonary infections that are due to laboratory confirmed Legionella infection, laboratory confirmed or presumed Nocardia infection, or laboratory confirmed or presumed Nontuberculous mycobacteria (NTM). It also notably excludes azithromycin orders intended for immunomodulatory effect.

Provider Responsibilities

  • The provider is responsible for the general supervision of the patient’s care.
  • The provider will be available to discuss care pursuant to this protocol if needed.
  • The provider may override this protocol when they deem such action necessary or appropriate for a specific patient.

IV.  Documentation/Communication

  • The pharmacist shall document all interventions and activities appropriately in the patient’s electronic medical
    • The pharmacist will discontinue the azithromycin order per pharmacist protocol. Then the pharmacist will document in the order comments that the medication was discontinued per azithromycin discontinuation protocol.
  • Circumstances that shall cause the pharmacist to initiate communication with the patient’s provider:
    • Need to initiate therapy OR when there is question regarding indication for azithromycin therapy OR if the pharmacist identifies alternative reason (besides 1500 mg limit) for discontinuing / modifying azithromycin therapy indication for azithromycin therapy
    • Critical lab
    • Adverse drug reaction necessitating physician evaluation in the professional judgment of the pharmacist (i.e., patient allergies, adverse drug reactions, drug interactions, etc.).
  • If a medication error occurs, it will be reported per UIHC

V.  Quality Assurance

  • On an annual basis, the Antimicrobial Stewardship team will review a subset of patients to confirm that appropriate care is being provided pursuant to this protocol.
  • This protocol will be reviewed and updated every three years or more frequently based on changes in clinical

VI.  Pharmacist Training and On-going Competency

  • Each new pharmacist who provides care pursuant to this protocol will be trained and evaluated during an orientation period. Therapeutic plans and electronic notes will be reviewed during the orientation period as part of that

VII.  Related Standard(s)

PC-PCI-05.54, “Pharmacist and Physician Participation in Collaborative Drug Therapy Management”

UIHC Community Acquired Pneumonia MicroGuide

VIII.  References

·       Socan M. Treatment of atypical pneumonia with azithromycin: comparison of a 5-day and a 3-day course. J Chemother. 1998 Feb;10(1):64-8.

Date created: 3/26/2020

Source: Department of Pharmaceutical Care

Date of Pharmacy and Therapeutics Subcommittee approval:

4/2/2020

Date effective:

Date Revised: Date Reviewed:

Drug Monitoring Considerations for COVID Positive Patients
Updated on 05/29/2020 at 5:04 pm

This document is intended to guide clinical teams in evaluating whether routine monitoring of a patient can be delayed if the patient has a lab-confirmed COVID-19 infection. Please consult with the listed pharmacy contact for any questions.

Nebulizer Treatment to Metered Dose Inhaler Interchange to minimize risk of exposure to staff
Updated on 07/20/2020 at 1:26 pm

University of Iowa Health Care

Guidance on Treatment Options for Patients with SARS-CoV-2

PROTOCOL TEMPORARILY CREATED PURSUANT TO AUTHORITY OF HOSPITAL INCIDENT COMMANDER ACTIVATED IN RESPONSE TO COVID-19. EFFECTIVE UNTIL FURTHER NOTICE.

Date Created Per HICS: 7/15/2020                                                             Date Amended:

University of Iowa Hospitals and Clinics (UIHC)

Pharmacist Collaborative Practice Protocol Nebulized Treatment to Metered-Dose Inhaler Interchange

  1. Purpose & Goals

Purpose

  • Manage use of metered-dose inhalers (MDIs) and nebulized treatments to optimize drug delivery and minimize risk of exposure to staff. This protocol outlines pharmacist managed therapeutic interchange of select metered-dose inhalers and nebulization

 

Goals

  • To optimize medication delivery of inhaled
  • To optimize MDI medication availability for patients.
  • To minimize risk of exposure to staff members who administer or assist with administration of inhaled drug

 

ii.          Providers Authorized

  • Providers caring for adult and pediatric inpatients and observation patients at UIHC will automatically be enrolled in this protocol. Pharmacists providing care to adult and pediatric inpatients and observation patients may act pursuant to this

 

iii.          Responsibilities Authorized by this Protocol

Pharmacist Scope of Practice

  • Once a patient has been identified as having a nebulized treatment that qualifies for substitution, the pharmacist should evaluate the need for the medication. If the need for the medication is not apparent, the pharmacist should contact the provider to discontinue. If the medication is necessary, the pharmacist will contact the RN or respiratory therapist caring for the patient to determine if the patient is capable of proper MDI use.
    • Continuous nebulization is not eligible for conversion to an MDI.
    • If a patient has a severe, life-threatening respiratory disease and/or is unable to perform proper technique (due to respiratory status or age) required for MDI use, patient may continue to receive the nebulized therapy. The prescriber, Nursing staff, and Respiratory Therapy should be consulted to determine the necessity of the medication and the safest and most appropriate product and dosage form for adequate drug delivery.
  • If the patient is receiving a medication via nebulization that does not have an MDI alternative, the patient should be maintained on nebulization treatments for all pre-medications. The effort to consolidate nebulized treatments to be given at similar times should be done in order to decrease the use of additional personal protective equipment (PPE).
    • If patient is receiving other nebulized treatments that are able to be switched to an MDI, but the schedule is such that the timing cannot be aligned with the nebulized treatments (that do not have an MDI alternative), then the nebulized treatments that can be switched to MDI should be switched to MDI. For example, if patient is receiving aztreonam (which cannot be switched to an MDI) and is receiving albuterol for a premedication for that aztreonam treatment, then the albuterol premedication should NOT be switched to an MDI; however, if the patient receives albuterol nebulization independent of the aztreonam, that order should be switched to MDI in order to decrease exposure to staff and conserve PPE) .
  • If the patient has been determined to be capable of proper MDI technique, and all nebulized treatments can be switched to an appropriate MDI, the pharmacist will place the appropriate orders as outlined in Appendix A.
Steroid Equivalent Dose
Betamethasone 3 mg
Cortisone 100 mg
Dexamethasone 3 mg
Hydrocortisone 80 mg
Methylprednisolone 16 mg
Prednisolone 20 mg
Prednisone 20 mg
  • If a patient is receiving an equivalent of a 20 mg or more of systemic (enteral or IV) prednisone daily (see equivalency chart below), then the inhaled steroid (neb or MDI) may be discontinued.
    • Once the systemic steroid is discontinued or the daily dose falls below an equivalent of a 20 mg or more of systemic (enteral or IV) prednisone daily, the pharmacist may restart the inhaled steroid via MDI. If a nebulized treatment is necessary, the attending provider must be contacted.
  • In addition to the medication orders outlined in Appendix A, the pharmacist will also place an order for a spacer (e.g., an Aerochamber) device to be used with the appropriate MDIs.
  • Additionally, if a patient has an active order for a PRN nebulized treatment, but the medication has not been used in 48 hours, the order may be discontinued by the pharmacist.

Provider Responsibilities

  • The provider is responsible for the general supervision of the patient’s
  • The provider will be available to discuss care pursuant to this protocol if
  • The provider may override this protocol whenever he or she deems such action necessary or appropriate for a specific

Medical Director Responsibilities

  • Jason Wilbur, MD, Clinical Professor, Family Medicine, Co-Chair, Pharmacy & Therapeutics Working Group (or his designee) will oversee the responsibilities of the pharmacists and providers operating under this protocol.

 

iv.          Documentation/Communication

  • The pharmacist shall document all interventions through placement of new or modified orders in the manage orders
  • Circumstances that shall cause the pharmacist to initiate communication with the patient’s provider:
    • Clarification on indication or dosing for therapy
    • Adverse drug reaction necessitating physician evaluation in the professional judgment of the
  • If a medication error occurs, it will be reported per standard

 

v.          Quality Assurance

  • This protocol will be reviewed and updated annually or more frequently based on changes in clinical

 

vi.          Pharmacist Training and On-going Competency

  • Each pharmacist who provides care pursuant to this protocol will be trained and evaluated during an orientation

vii.          Related Standard(s)

PC-PCI-05.54, “Pharmacist and Physician Participation in Collaborative Drug Therapy Management”

viii.          References

 

ix. Signatures

For signed hard copies, please contact Jamie Smesler at 353-7376

 

Date Date
Jason Wilbur, MD Clinical Professor Family Medicine

Co-Chair, Pharmacy & Therapeutics Working Group

University of Iowa Hospitals and Clinics

Michael Brownlee, PharmD, MS, FASHP Chief Pharmacy Officer

Associate Director

Co-Chair, Pharmacy & Therapeutics Working Group University of Iowa Hospitals and Clinics

Date created: July 2020

Source: Department of Pharmaceutical Care

Date of Pharmacy and Therapeutics Working Group approval:

Date of HICS approval: 07/14/2020

Date effective:

Date Revised: 07/15/2020

Date Reviewed:

Appendix A

Metered-Dose Inhaler and Nebulization Therapeutic Interchange Protocol

Purpose: The goal of this protocol is to optimize drug delivery via either metered-dose inhalers (MDIs) or nebulization treatment, minimize risk of exposure to staff, and reduce waste by enabling pharmacists to implement therapeutic interchange through a collaborative practice agreement.

Policy: Pharmacists will be able to convert nebulized treatments to therapeutically equivalent MDIs on all adult and pediatric inpatients and observation patients unless otherwise specified.

Scope: Adult and pediatric inpatients and observation patients at UIHC are subject to this protocol.

Procedure:

  1. A provider places an order for an inhaled medication included in Tables 1 & 2 (listed below).
  2. In the pharmacist’s usual review of medications, they identify inhaled medications that are eligible for interchange pursuant to the collaborative practice
  3. Pharmacists will contact the patient’s RN or respiratory therapist who will assess the ability of the patient to properly use an MDI.
    1. If a patient has a severe, life-threatening respiratory disease and/or is unable to perform proper technique (due to respiratory status or age) required for MDI use, patient may continue to receive the nebulized therapy. The prescriber, Nursing staff, and Respiratory Therapy should be consulted to determine the necessity of the medication and the safest and most appropriate dosage form for adequate drug delivery.
  4. When a pharmacist receives an order for any of the medications listed in Tables 1 or 2, and the patient is capable of using an MDI properly, they will discontinue the order and enter the appropriate medication, dose, and frequency for therapeutic interchange and place an order for a spacer device.
    1. If a patient is on systemic steroids (doses ≥ 20 mg prednisone daily) the pharmacist will discontinue inhaled steroids, both nebulized and/or MDI formulation. Upon discontinuation, the pharmacist will enter a comment in the “RPh To-Do” handoff indicating:
  • Planned end date for systemic steroids if known
  • Reminder to resume inhaled steroid when systemic steroid dose is < 20 mg prednisone equivalent daily
  • If the patient is a pediatric patient, the attending faculty physician must be notified
  1. All orders will be placed under “Pharmacist Protocol” and will not require co-signature by the original
  2. PRN orders for nebulized treatments may be discontinued if the medication has not been administered for 48 hours (or more).

 

Therapeutic Interchange: Nebulized TreatmentstoMDIs

Nebulizer Solution Ordered Medication Order Placed by Pharmacist
Short-acting Anticholinergics
Ipratropium 0.02% Ipratropium bromide (Atrovent HFA®), 2 inhalations with dosing interval to match the original order
Short-acting Beta-2 Agonists
Albuterol 0.083% Albuterol MDI (Ventolin HFA®) 2 inhalations with dosing interval to match original order
Short-acting Beta-2 Agonist – Short-acting Anticholinergic Combinations
Albuterol-ipratropium 2.5-0.5 mg/3 mL (DuoNeb®) Albuterol MDI (Ventolin HFA®) 2 inhalations with dosing interval to match original order

 

NICU: dose determined by consult with ordering provider with dosing interval to match original order

NOTE: The pharmacist must contact the physician to determine if the patient has a need for either ipratropium bromide (Atrovent HFA®) 2 inhalations with dosing interval to match the original order OR Combivent® Respimat® 1 inhalation with dosing interval to match the original order

Corticosteroid
Budesonide nebulizer solution*

0.25 mg/2 mL

or

1 mg/2 mL

If a patient is receiving an equivalent of a 20 mg or more of systemic (enteral or IV) prednisone daily, inhaled corticosteroid therapy is not necessary. The budesonide nebulizer solution should be discontinued, and no alternative MDI should be ordered.*

 

Non-Ventilated Patients:

  • 12 years of age or older: Fluticasone furoate (Arnuity Ellipta®) 1 inhalation of 100 mcg or 200 mcg once daily, based on prior asthma therapy and disease severity
  • 5 to 11 years of age: Fluticasone furoate (Arnuity Ellipta®) 1 inhalation of 50 mcg once daily
  • Younger than 5 years of age: Fluticasone propionate HFA 44 mcg inhaler, 1 to 2 inhalations twice daily, based on prior asthma therapy and disease severity
  • NICU: dose determined by consult with ordering provider with dosing interval to match original order

 

Ventilated Patients:

  • 12 years of age or older: Fluticasone propionate HFA 110 mcg or 220 mcg inhaler, 1 to 2 inhalations twice daily, based on prior asthma therapy and disease severity
  • 5 to 11 years of age: Fluticasone propionate HFA 44 mcg or 110 mcg inhaler, 1 to 2 inhalations twice daily, based on prior asthma therapy and disease severity
  • Younger than 5 years of age: Fluticasone propionate HFA 44 mcg inhaler, 1 to 2 inhalations twice daily, based on prior asthma therapy and disease severity
  • NICU: dose determined by consult with ordering provider with dosing interval to match original order

* If a patient is on systemic steroids (doses ≥ 20 mg prednisone daily) the pharmacist will discontinue inhaled steroids, both nebulized and/or MDI formulation. Upon discontinuation, the pharmacist will enter a comment in the “RPh To-Do” handoff indicating:

  • Planned end date for systemic steroids if known
  • Reminder to resume inhaled steroid when systemic steroid dose is < 20 mg prednisone equivalent daily
  • If the patient is a pediatric patient, the attending faculty physician must be notified
Bamlanivimab Fact Sheet for Health Care Providers
Updated on 11/23/2020 at 1:52 pm

Bamlanivimab Fact Sheet for Patients
Updated on 11/23/2020 at 1:53 pm

COVID-19 testing

Testing criteria
Updated on 12/15/2020 at 8:28 am

Symptomatic Patient Testing Criteria (“NOVEL CORONAVIRUS COVID-19”)

Asymptomatic Patient Exposed to COVID-19 Criteria (“COVID-19 HIGH RISK EXPOSURE)

  • Patient was in close contact (spending more than 15 minutes total over a 24-hour period within 6 feet) of a person with lab confirmed COVID-19 infection
  • Recommended sample collection is 7 days after last exposure to the person with COVID-19 during that person’s infectious period.  If a patient presents between 8-10 days after the last exposure, they will be tested once on ASAP. If they present 11-14 days after last exposure, the decision to order the test will be based on a conversation between the patient and provider.

 Screening test criteria (“COVID-19 Asymptomatic Screen: RESTRICTED”)

Ordering and collecting a COVID-19 test
Updated on 12/15/2020 at 8:29 am

RE-TESTING FOR COVID-19 in symptomatic patients who have not tested positive in the last 90 days.

Patients with COVID-19 typically have high titers of virus in the oro- and nasopharynx and therefore, the OP or NP swab is a sensitive test. However, over the course of the illness, the levels of virus in the upper airway decline – even in patients with progressive lower respiratory tract illness.  Most asymptomatic COVID-19 patients also have high viral titers, though the kinetics of viral load are not well understood very early in infection.

Therefore, there are two scenarios where retesting may be necessary:

  1. The patient tested negative but was very early in their course of illness, and/or were asymptomatic, and/or did not have COVID-19 (these scenarios cannot be distinguished in most cases).  The patient later developed symptoms consistent with COVID-19, and met criteria for symptomatic testing.  Sample type for retesting in this case may be NP, OP or sputum.
  2. The patient presented with a long course of illness (>=7 days) and an NP or OP swab was negative.  Repeating an NP or OP swab in this case is not recommended as it does not access the lower respiratory tract where virus is more likely to be found; sputum, tracheal aspirate or BAL is recommended for retesting in these cases.

Retesting will be screened for in Epic on an active basis, and cases not approved will have testing canceled. Page *4903 to discuss circumstances with the pathology resident on call to streamline approval if criteria are met.

RE-TESTING FOR COVID-19 in symptomatic or high-risk exposed asymptomatic patients who have previously tested positive within the last 90 days.

 Patients with a previous COVID-19 infection may test positive with the PCR test for weeks or months after an infection.  For this reason, a test-based strategy to return to work or discontinue isolation is not recommended.  A symptom-based strategy to discontinue transmission-based precautions is described below:

  1. Patients with mild to moderate illness who are not severely immunocompromised:
    1. At least 10 days have passed since symptoms first appeared (or since positive test if asymptomatic) and
    2. At least 24 hours have passed since last fever without the use of fever-reducing medications and
    3. Symptoms (e.g., cough, shortness of breath) have improved/are improving
  2. Patients with severe to critical illness or who are severely immunocompromised:
    1. 20 days have passed since symptoms first appeared (or since positive test if asymptomatic) and
    2. At least 24 hours have passed since last fever without the use of fever-reducing medications and
    3. Symptoms (e.g., cough, shortness of breath) have improved

Patients who have previously tested positive for COVID in the past 90 days should not be routinely re-tested if new symptoms develop.  Re-testing could be considered if symptoms are highly specific for COVID (loss of taste or smell with fever or respiratory symptoms) AND the patient had a recent high-risk exposure (within 6 feet of a person with lab confirmed COVID for more than 15 minutes over a 24 hour period during the source person’s infectious period).  Patients with symptoms and a high-risk exposure should be tested ASAP and, if first test is negative, again on day 7-10 of quarantine if they present on day 1-5 post exposure.  If a patient with symptoms and a high-risk exposure presents on day 6-14 post exposure, they should only be tested one time, ASAP.

Patients with a previous positive COVID test in the past 90 days who have had a high-risk exposure and are currently asymptomatic do not need to quarantine and retesting is not recommended.

Patients with a previous positive COVID test in the past 180days should not be retested prior to undergoing pre-procedure asymptomatic screening with a COVID PCR test. Similarly, hospitalized patients without a known high-risk COVID exposure who have had a previous positive COVID test in the past 180 days should not be retested upon admission or routinely throughout their hospital stay.

Typical turnaround time for COVID-19 testing
Updated on 12/15/2020 at 8:31 am

Results will typically be ready in up to 12 hours of receipt in the Microbiology Lab and are often available earlier. On occasion, resulting could extend up to 24 hours due to performance of the assay, reagent availability and instrumentation down time. The appropriate provider will be notified of any positive or indeterminate result.

Providers can view all results in Epic once results have been verified. MyChart results are available less than 1 hour after availability in Epic.

Do not call the laboratory to ask about timing of results; this delays testing for all patients. Predicted turnaround times will not be provided for individual cases. Surgical subcommittee guidelines describe planning scheduled and unscheduled surgical cases around COVID-19 testing.

Random access (also known as “rapid” or “stat”) testing is automatically performed in cases approved by HICS. This type of testing is not orderable and is not available by request.

Universal Maternal Testing for COVID-19
Updated on 07/17/2020 at 12:42 pm

COVID-19 Swab Kits available to most patient care areas
Updated on 05/12/2020 at 9:25 am

Effective on or before Tuesday, May 13, 2020, COVID-19 Swab Kits will be available to most patient care units/clinics on the main UI Hospitals & Clinics campus via the Omnicells (with the exception of swab kits  supplied to the ED and the ILI Clinic, which will follow our current processes for those areas). As of that date, if you need a swab kit in order to collect a specimen from a patient for COVID-19 testing, first check your Omnicell for the kit (most areas will have both OP and NP kits stocked in their Omnicells, so be sure to choose the correct one based on the site from which you will obtain the specimen). Once you have collected the specimen, then either deliver the specimen to the Microbiology lab or contact the COVID-swab runner by text (preferred) to COVID-19 or place a voice call to 8-0954 or 319-678-0954. A swab runner will pick up the specimen and deliver it to the Microbiology lab. As a reminder, swab specimens in liquid viral media (such as specimens collected for COVID-19 testing) cannot be sent via the pneumatic tube system; they must be hand carried to the Microbiology Lab. 

An initial supply of kits will be placed in each Omnicell based on recent or anticipated testing needs. Staff from Processed Stores will replenish the kits, using products supplied by Pathology, as they replenish other Omnicell supplies. If you find you have no kits available when you look in your Omnicell, please contact the COVID-swab runner, and a kit will be delivered to you by the swab runner. Please do not contact Processed Stores to request a replacement kit.

Questions? Contact Heidi Nobiling (heidi-nobiling@uiowa.edu) if you have questions or concerns about this change.

Q&A: COVID-19 (SARS-Cov-2) Serological Testing
Updated on 11/18/2020 at 4:09 pm

Guidance on Management of People with High-Risk SARS-CoV2 Exposure
Updated on 12/15/2020 at 8:34 am

Program of Hospital Epidemiology Guidance on Management of People with High-Risk SARS-CoV-2 exposure

12/10/20

SARS-CoV-2 exposure: Contact with a person (source person) who has laboratory confirmed SARS-CoV-2 during the time period when the source was likely to be infectious, unless adequate PPE was always used (see below).  If appropriate PPE was used throughout the entire contact, risk of exposure is low and no additional evaluation or management is necessary.

High-Risk Contact definitions:

  1. Being within 6 feet for a total of 15 minutes or longer over a 24 hour period IF the exposed person was not wearing a facemask or respirator.
  2. Being within 6 feet for a total of 15 minutes or longer over a 24 hour IF the exposed person was not wearing eye protection AND the source person was not wearing a cloth face covering or medical grade mask.
  3. Being in the same room as the source person during an aerosol generating procedure IF the exposed person was not wearing gown, gloves, eye protection, and a respirator.
  4. The exposed person had direct unprotected contact with infectious secretions or excretions from a source person.
  5. Household contacts of a source person are high-risk contacts unless there has been complete scrupulous in-home isolation.
  6. Health Care Personnel (HCP) can be exposed through high-risk contact at work or in the community. Management of the exposure is the same regardless of the location of the exposure.

Infectious period:

  1. Source person is symptomaticThe infectious period begins 48 hours before the source person’s symptom onset and ends when the source person meets criteria for discontinuation of COVID-19 isolation precautions.
  2. Source person is asymptomatic: The infectious period begins 48 hours before the source person’s first positive test and ends 10 days after the source patient’s first positive test. If the time of exposure that led to the source person’s infection is known, then the infection period begins 48 hours after the earliest exposure.
    • In some circumstances, public health may define the infectious period for an asymptomatic person as starting 10 days before the source person’s first positive test.

Post-exposure SARS-CoV-2 testing:

  1. SARS-CoV-2 PCR testing is recommended (not required) for all exposed individuals. Testing should occur:
    • Preferred timing for post-exposure testing is 7 days. If a patient presents on day 0-7 post exposure, test once on day 7. If a person presents on day 8, 9 , or 10 post exposure, test only ASAP. If a person presents on 11-14 days after last exposure, the decision to order a test will be based on a conversation between the patient and provider.
    • Must be at least 48 hours after the earliest exposure.
    • Not more than 14 days after the last exposure.
  2. If the test result is positive, the individual should immediately self-isolate and contact their primary care provider and/or the UIHC telehealth /ILI system.
  3. The Iowa Department of Public Health recommends that persons with a high-risk exposure to a person with COVID-19 complete a 14 day in-home quarantine if possible. However, if a 14-day quarantine represents a significant burden to the exposed person, there are options for early release from in-home quarantine:
    • Early release after 7 days of in-home quarantine may be considered if a person remains without symptoms and has a negative test on or just before the 7th day.  However, during the remaining 7 days of quarantine, the person must:
      1. Continue to monitor for symptoms of COVID-19
      2. Wear a face mask at all times
      3. Maintain social distance
      4. Follow all other safety measures recommended by public health
    • Early release after 10 days of in-home quarantine may be considered if a person remains without symptoms without any testing.  However, during the remaining 4 days of quarantine, the person must:
      1.  Continue to monitor for symptoms of COVID-19
      2. Wear a face mask at all times
      3. Maintain social distance
      4. Follow all other safety measures recommended by public health
  1. If the test result is negative the individual should continue with self-quarantine and monitoring as described below.
  • If an individual develops symptoms during quarantine for an exposure, they should contact their PCP or the UIHC telemedicine/ILI system.
  • If an individual has an additional exposure during their quarantine period the quarantine period will be adjusted such that the last possible exposure is counted as “day 0” of quarantine

Home Quarantine and Work Restrictions

  1. Symptomatic individuals should be evaluated and managed by their primary care provider or through the UIHC telehealth / ILI system.  Symptomatic UIHC personnel should contact employee health.
    • Symptomatic healthcare personnel (HCP) may return to work when at least 10 days have passed since symptoms first appeared and at least 24 hours have passed since recovery (resolution of fever without the use of fever-reducing medications and other symptoms are improving).
  2. Asymptomatic individuals:
    • Health Care Personnel(HCP) who have had a high-risk contact with a person with laboratory confirmed SARS-CoV-2 infection should self-quarantine at home / be excluded from work for 7 days with a negative test or 10 days without a test if they remain asymptomatic.  They will need to complete a 14 day of quarantine by monitoring symptoms, wearing a face mask, social distancing, and following all other safety measure recommended by public health.  If staffing shortages occur, strategies for mitigating HCP staffing shortages may dictate that asymptomatic HCP with high-risk contact may continue to work, following the guidance for essential personnel described below.
      • Decisions about whether or not an exposure event warrants work restriction / quarantine of HCP will be made by the University Employee Health Clinic (UEHC). If an individual has concern about an exposure, they should contact University Employee Health Clinic (UEHC).
    • Essential personnel / critical infrastructure workers may continue work following potential exposure to COVID-19, provided they remain asymptomatic and additional precautions are implemented to protect them and the community.
    • People who are NOT health care workers or essential personnel / critical infrastructure workers should follow standard quarantine guidelines.
NP Specimen Collection
Updated on 06/10/2020 at 11:20 am

Management of COVID-19 inpatient exposure
Updated on 03/01/2021 at 1:02 pm

COVID-19 inpatient exposure is defined as sharing an inpatient room for 15 minutes or longer with a source patient with laboratory confirmed SARS-CoV-2 during the source patient’s infectious period.

  1. Source patient is symptomaticThe infectious period begins 48 hours before the source patient’s symptom onset and ends when the source patient meets criteria for discontinuation of COVID-19 isolation precautions.  If the source patient met criteria for discontinuation of isolation precautions BEFORE the room was shared, the patient was not exposed.
  2. Source patient is asymptomaticThe infectious period begins 48 hours before the source patient’s first positive test and ends 10 days after the source patient’s first positive test.

Note: If a health care worker develops COVID-19, patients and staff that had contact with the infected HCW are not considered exposed as long as the infected health care worker was using recommended PPE.

Management of potentially exposed patient:

  • Have the source patient don a medical grade mask immediately. The source patient must wear the mask continuously until they have been moved to a private room.
  • Care for potentially exposed patient in a private room.
  • One room management option is to keep the potentially exposed patient in place but once the source patient is moved to a private room, keep that bed in the room vacant until the source patient’s SARS-CoV-2 testing is resulted.
  • Notify attending provider of the potential exposure.
  • Place an order for the potentially exposed patient to be cared for with droplet precautions. While all staff are currently following “universal” droplet precautions by wearing face shield and eye protection, placing an order for droplet precautions communicates the need for a private room in the EMR and bed management systems.
  • If the source patient’s SARS-CoV-2 test is positive, droplet precautions for the exposed patient remain in effect for 10 days after the last exposure to the source patient. The 10-day period is calculated using the last date of exposure as day 0.
  • If the source patient’s SARS-CoV-2 test is negative, the potentially exposed patient was not exposed, droplet precautions are discontinued, and a private room is no longer required.
  • Page the Program of Hospital Epidemiology at pager 3158.
  • Patient should be notified by the attending provider that they were potentially exposed to SARS-CoV2. This notification occurs before the test result is back.
  • Do not disclose to the exposed patient specifics of who was the source of the exposure or other details about the exposure. Per Legal, this should be referred to as “a potential exposure.”
  • Do not discuss with the patient the type of exposure or their level of risk for developing COVID-19. We do not have enough data or experience to be able to predict the risk of infection after this type of exposure.
  • If an exposed patient is discharged prior to discovery of the exposure, the patient AND their primary care provider need to be notified about the exposure. The attending who discharged the patient or an alternate provider designated by the discharge attending will perform these notifications with the support of the Program of Hospital Epidemiology if needed at pager 3158.
  • The person who notifies the exposed patient should provide them with the information in the discharge instructions for patients with potential exposure to SARS-CoV-2, including the date on which their home quarantine period is over.  The period is calculated using the last date of exposure as day 0. These discharge instructions are available in Epic using the SmartPhrase .coviddischinst or SmartText HCI: COVID-19 Exposure Discharge.
  • Potentially exposed patients who are discharged should be tested for SARS-CoV-2 5-7 days after last exposure to a person positive for SARS-CoV-2 during that person’s infectious period. If the potentially exposed patient is not symptomatic they can be released from in-home quarantine after 7 days with a negative test or 10 days without a test.  They will need to complete 14 days of monitoring symptoms, wearing a face mask, social distancing, and following all other safety measure recommended by public health.  If it has been more than 14 days after their last exposure to the source patient, testing is no longer indicated.
  • If this test result is negative, the patient is still an exposed patient and must continue to be cared for in a private room or self-quarantine at home until 10 days after their last exposure.
  • If an outpatient needs to be tested, place the order CON ILI Telemedicine (or REF716). Select schedule “other” and then 2-3 days post discharge on a weekday.
  • Monitor for symptoms of COVID and document temperature at a minimum of BID. If the exposed patient develops any symptoms of COVID after their initial screening test, they should be placed in contact/droplet/eye protection precautions and re-tested for SARS-CoV-2.
  • If an exposed patient is discharged before the 10-day quarantine period is over, notify the patient’s primary care provider about the potential exposure and include the instructions for patients with potential exposure to SARS-CoV2 in their discharge instructions. These instructions include the date on which their home quarantine period is over.  This date is calculated as after the last exposure, using the last day of exposure as day 0.  These discharge instructions are available in Epic using the SmartPhrase .coviddischinst or SmartText HCI: COVID-19 Exposure Discharge.
  • Post exposure test costs will be covered by UIHC.  PHE will provide patient and test details to  Risk Management.

References

Centers for Disease Control and Prevention (CDC). (2020, December 2020). COVID-19 (Coronavirus Disease). Retrieved from When to Quarantine: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html

IDPH (5/27/20)  2019 Novel Coronavirus Resources for Local Public Health Partners.  https://idph.iowa.gov/Portals/1/userfiles/61/covid19/Coronavirus%20Procedures%2005_27_2020.pdf

Exposed Patients Quick Reference

Situation Time Considerations
Inpatient

Quarantine (exposed)

10-days.  Calculate days by using the last date of exposure as day 0.

 

Test patients for SARS-CoV-2 on day 0, 5 and 10.

All tests must be negative before ending quarantine.

Discharged patient on quarantine (exposed) If patient has already had their day 5 test, they remain negative and they are asymptomatic, they should quarantine through day 7 (out of quarantine on day 8) and no further testing is needed.

 

If the patient is being discharged prior to the day 5 test, the primary provider will need to place the following order: CON ILI Telemed (or REF716) and choose schedule “other” and then 2-3 days post discharge on a weekday. ILI will follow a 7-day quarantine period with testing on day 7. If negative, come out of quarantine on day 8.

 
ILI COVID-19 Testing Algorithm
Updated on 12/15/2020 at 11:01 am

Protocol for ordering point of care rapid COVID-19 testing using the Abbott ID
Updated on 08/17/2020 at 8:00 am
SUBJECT/TITLE: Protocol for Ordering Point of Care Rapid COVID-19 Testing Using the Abbott ID Now for Patients Undergoing Procedures or Surgery During  the Emergency Disaster Declaration Time Period 
PURPOSE: To ensure rapid testing and availability of results for COVID-19 prior to procedure or surgery (planned / potential aerosolized generating procedure).
TARGET POPULATION: Patients undergoing surgery in the Main Operating Room (MOR), Ambulatory Surgery Center (ASC), Stead Family Children’s Hospital (SFCH), and procedural locations.
DEFINITIONS: None

CRITERIA:

  1. Asymptomatic patients scheduled to undergo a procedure or surgery at UIHC.
    Note: COVID-19 screening is to be done within 24 hours of scheduled procedure/surgery unless otherwise specified in Contraindications.
  2. Class A, Class B, or awaiting test result would delay procedure
  3. Performed on Abbott ID Now platform

CLINICAL ASSESSMENT/SCREENING:

  1. Allergies: Not applicable.
  2. Contraindications: Refer to 2019 Novel Coronavirus (Covid-19) Information Hub for Employees for most current criteria.
    1. If a patient has COVID-19 symptoms, the provider will need to place the COVID-19 symptomatic screening order. This testing is completed by the Microbiology Lab.
    2. If two invalid results occur, the provider will need to place the COVID-19 asymptomatic screen by PCR: restricted. This testing is completed by the Microbiology Lab.
    3. Nasopharyngeal route of testing not available (e.g. nasopharyngeal should not be used for patients with a history of nasal trauma, bleeding disorders, nasal medications, or deviated septum). Nasal and throat routes of testing not approved by UIHC for use on the Abbott ID Now.

DETAILS OF THE ORDER: The RN/LPN/MA/Clin Tech/Paramedic will place an order in the EHR under the surgical/procedural encounter using the order mode “per protocol” for the following:

  1. Name of treatment, test or medication: POC COVID-19 (aka Asymptomatic Rapid COVID-19) POC90
  2. All relevant details necessary to complete order (i.e., dose, route and frequency for medications): Nasopharyngeal.
  3. Monitoring parameters if indicated: None
  4. Precautions, observations, considerations and circumstances for contacting provider:
    1. Positive result
    2. Two invalid results

DOCUMENTATION REQUIREMENTS:

  1. Staff utilizing protocol must document an order to initiate the protocol in patient’s medical record per the “Protocol Orders” clinical protocol.
  2. Indicate location of documentation in the medical record: Lab tab of Chart Review and Results Review.

RELATED STANDARDS:

Surgical Subcommittee Guidelines – Asymptomatic Pre-procedure Screening Guidelines

REFERENCES:

Entering external COVID-19 test results
Updated on 02/25/2021 at 2:27 pm

Surgical services guidelines

Surgical Subcommittee Guidelines- Asymptomatic Pre-Procedure Screening Guidelines
Updated on 01/13/2021 at 10:06 am

Hospital Incident Command System (HICS) Directive April 10, 2020

The local environment of the COVID-19 Pandemic has enabled us to update the guidelines for PPE and COVID-19 testing in the operating rooms and procedural locations. The following revised guidelines are for all patients requiring emergent and essential surgical management in the UIHC operating rooms and procedural locations. The definitions of Class A and Class B emergency are unchanged. Urgent surgery, including Class C and D add-ons, will be in line with the guidelines released by the Governor’s office, and determined as urgent by the chair of the surgical department. Essential surgery and procedures include nonemergency/nonurgent procedures that are still allowed by the Governor’s directive (e.g., cancer surgery). A few essential issues need to be considered:

1. The guidelines apply to all procedural locations at UIHC:

  1. Main Operating Rooms
  2. Ambulatory Surgery Center
  3. SFCH Operating Rooms
  4. Urology Cystoscopy Suite
  5. Labor and Delivery
  6. Digestive Health Center Procedure Suite
  7. Cardiac Cath Lab
  8. Radiation Oncology
  9. Electroconvulsive Therapy (ECT)
  10. Interventional Radiology/MRI/CT
  11. Transesophageal Echocardiography (TEE)
  12. Pediatric Cardiac Cath Lab
  13. SFCH LL2 Procedure Suite
  14. Bronchoscopy Lab (only cases scheduled with Anesthesia)

2. As directed by the Governor, ICU bed and hospital bed availability will dictate OR utilization as will the HICS Surge Classification. OR utilization will gradually increase to comply with the Governor’s Proclamation related to surgeries and procedures.

3. Departments will be able to schedule into their previously allotted room allocation.

4. The guidelines may require immediate alteration and shut down of scheduled essential cases if a surge develops.

5. When inpatient census is at a level where we need to surge into the overflow locations (CPRU, DHC, MOR PACU, ASC PACU, SFCHOR PACU) only emergent/urgent surgeries and procedures will be done.

6. In the event that a high level COVID-19 activity occurs within the hospital, the hospitalists assigned to your service will likely be re-assigned within the hospital and may be unavailable for surgical care.

7. The surgical and anesthesia teams are encouraged to use regional anesthesia when appropriate.

COVID testing procedures and OR processes

  • Class A Emergency procedures will be performed with Airborne/Contact/Eye Precautions (including gowns, gloves, N95 respirators, and face shields, negative pressure OR) for all providers in the operating room, unless one or more of the following applies:
    • The patient has been inpatient AND has a negative COVID-19 test in the chart that is ≤ 2 days old*
    • A COVID-19 rapid test obtained after the patient has arrived in the operating room is negative. (For rapid testing protocol, see )
    • The patient’s infection status is known to be “Recently Recovered from COVID-19” (e.g., the patient has a positive COVID-19 test within the past 180 days and is deemed non-infectious; see Surgical Services Guidelines section for Positive COVID-19 Test )
  • Class B Add-on procedures that cannot be delayed for COVID-19 testing will be performed with Airborne/Contact/Eye Precautions (including gowns, gloves, N95 respirators, and face shields, negative pressure OR) for all providers in the operating room, unless one or more of the following applies:
    • The patient has been inpatient AND has a negative COVID-19 test in the chart that is ≤ 2 days old*
    • A COVID-19 rapid test obtained prior to the operating room is negative. (For rapid testing protocol, see Protocol for Ordering Point of Care Rapid COVID-19 Testing Using the Abbott ID Now)
    • The patient’s infection status is known to be Recently Recovered from COVID-19 (e.g., the patient has a positive COVID-19 test within the past 180 days and is deemed non-infectious; see Surgical Services Guidelines section for Positive COVID-19 Test )
  • Class C Add-on procedures are to be tested for COVID-19 by UIHC Department of Pathology prior to the procedure being performed, unless infection status is known to be Recently Recovered from COVID-19 (Surgical Services Guidelines section for Positive COVID-19 Test .
    • A COVID-19 test result is good for 2 days* for inpatients undergoing a procedure for which asymptomatic preprocedural COVID-19 testing is required.
  • Class D, U, and Elective Add-on procedures are to be tested for COVID-19 by UIHC Department of Pathology and must be collected by 11:30 a.m. the day prior to surgery, unless infection status is known to be Recently Recovered from COVID-19 (Surgical Services Guidelines section for Positive COVID-19 Test .
    • A COVID-19 test result is good for 2 days* for inpatients undergoing a procedure for which asymptomatic preprocedural COVID-19 testing is required.
  • Patients undergoing scheduled procedures (under general, regional, or MAC anesthesia) are to be tested for asymptomatic pre-procedural COVID-19 by UIHC Department of Pathology and must be collected by 11:30 a.m. the day prior to surgery.
    • Patients will be required to come to UI Urgent Care – Holiday Road the calendar day prior to their procedure for testing.
    • For scheduled procedures to be completed within 24 hours and identified after 11:30 a.m., the ILI Drive Thru Clinic testing at FCC Drive will be available between 1130-1900 Monday – Friday and 1130-1700 Saturday-Sunday.
      • This requires the same order panel and is scheduled by the PAC.
    • The surgical or procedural team will be responsible for ordering the test, notifying the patient of the test and time constraints, checking on the results on the evening prior to scheduled surgery, and alerting the OR of positive results.
    • Patients should be instructed to self-isolate in their home or local hotel/motel between testing and the procedure.
    • Testing will be required for all essential scheduled procedures the calendar day prior to the procedure.
      • Exceptions
        • If a surgical case is coordinated with another procedure the day prior to the surgical case (i.e. Dermatology Mohs procedure or Dialysis patients), the patient will be tested the day prior to the first scheduled procedure. This test result is good for 2 days. *

*Test is valid for day of the test and post-test day 1 and 2 until midnight of Day 2.

Process for patients with a previous COVID-19 positive test:

If acceptable documentation cannot be obtained, then follow approved processes for obtaining test at UIHC prior to procedure.

Acceptable documentation of a positive result from outside entity should include*:

  • Two patient identifiers
  • Collection date of test
  • Type of COVID-19 test (PCR or antigen is acceptable)

*This documentation should be scanned into Media of patient’s chart as well as entered accordingly into the Enter/Edit result function (step-by-step instructions available in linked document).

Positive COVID-19 test* based on timeframe:

Day 0–30 Day 31–180 >180 days
  • Do not schedule non-essential procedure. If there is a difference of opinion on the essential nature of the procedure, discuss with the Executive Medical Director of Perioperative Services.
  • If procedure must be scheduled, do not test. Follow processes based on Infection status in Epic Storyboard.
    • If COVID-19 or Rule Out COVID-19, follow active COVID-19 processes.
    • Otherwise, follow the isolation listed. Use of the negative pressure operating room is not needed.
  • Do not test; proceed with procedure. Follow processes based on Infection status in Epic Storyboard.
    • If COVID-19 or Rule Out COVID-19, follow active COVID-19 processes.
    • Otherwise, follow the isolation listed. Use of the negative pressure operating room is not needed.
  • Order asymptomatic test prior to procedure and follow processes based on test result.

 

*An indeterminate test result should be treated as a positive.

Day 0 is asymptomatic test date or date of symptom onset.

Day 0–30:

Do not schedule nonessential procedure within 30 days of the first documented positive COVID-19 test because of an increased risk for perioperative/periprocedural complications in the COVID-19 convalescent period. If there is a difference of opinion about proceeding with a case between anesthesiologist and surgeon, the Executive Medical Director of Perioperative Services is to be consulted to adjudicate.

If a procedure is essential and must be scheduled within 30 days of the first documented positive COVID-19 test, do not order asymptomatic test prior to procedure. Follow appropriate processes based on the Infection/Isolation status in Epic Storyboard.

  • If COVID-19 or Rule Out COVID-19 is present, then active COVID-19 processes are followed in the Perioperative/Periprocedural environment.
  • Otherwise, follow the isolation that is listed. Use of the negative pressure operating room is not needed.

Day 31–180:

  • Between days 31 and 180, do not order asymptomatic test, proceed with the procedure, and follow the Infection/Isolation status listed in Epic Storyboard. If COVID-19 or Rule Out COVID-19 is present, then active COVID-19 processes are followed in the Perioperative/Periprocedural environment.
  • Otherwise, follow the isolation that is listed. Use of the negative pressure operating room is not needed.

>180 days:

  • Order asymptomatic test prior to procedure and follow appropriate processes based on test result.

Transplant Patients:

  • Donors
    • Living donor evaluations and living donor surgeries have resumed.
  • Recipients
    • Living donor kidney transplants have resumed.
    • Patients called in for transplant
      • Should have no history of known exposure to COVID-19 or have COVID-19 type symptoms AND
    • Preferably have a negative COVID-19 test. We will test all potential recipients.
      • We will wait for a negative test result on all kidney recipients
      • We may not have time to wait for a negative result on all liver recipients though it is our preference to do so; the ability to do so depends on timing of recipient admission, test run availability and turn-around time, and timing of donor surgery. We will proceed without a test result if it is in the best interest of the patient. This is a fluid situation and can change depending on factors mentioned above.

Obtaining COVID-19 Testing and Ordering Testing:

This workflow centers on the surgeon or proceduralist placing two orders (one for the test and one for the visit) as well as notifying the patient that this testing is needed.

  1. The surgeon or proceduralist must place the specific Epic panel order FOL162 for an ILI pre-operative screening at Urgent Care – Holiday Road and COVID-19 asymptomatic testing. A checkbox will be within the order to indicate this is for an essential surgery.
  2. The surgeon’s or proceduralist’s clinic team must call the patient to let them know they need to come for preoperative testing the morning prior to the procedure.
  3. The PAC will call the patient to arrange appointment at the Urgent Care – Holiday Road testing location. The PAC will give the patient instructions on where to come for the testing.
  4. The PAC will provide the patient with appropriate instructions based on the anticipated specimen collection method:
    1. This will be a drive-thru testing. Patient will drive through the Urgent Care -Holiday Road parking lot and remain in their vehicle.
    2. Clinic staff will be stationed outside and approach the patient in their vehicle to collect a swab.
    3. Call the ILI Respiratory Clinic @ x8-6762, if needed, once they are outside the Urgent Care -Holiday Road and nobody is present.
  5. Drive Thru Clinic Hours: All testing will need to be completed between 7 a.m. – 11:30 a.m., the day prior to surgery for scheduled procedures, so the lab has the specimens by NOON.
  6. For same day add-on cases identified after 1130, the ILI Drive Thru Clinic testing will be available between 1130-1700 Monday-Friday and 1130-1500 Saturday-Sunday. The testing orders and workflow remain the same for these cases.
  7. The results from the COVID-19 test will be available in the chart and sent to the surgeon’s or proceduralist inbasket hopefully by late afternoon.
  8. The ILI team will notify patient of a POSITIVE result to provide education related to COVID-19.
  9. The surgical/procedure team will communicate with patient to notify of decision to proceed or postpone the surgery/procedure.

State of Iowa Proclamation of Disaster Emergency (10/16/2020)

NONESSENTIAL OR ELECTIVE SURGERIES AND PROCEDURES

SECTION FIVE. Pursuant to Iowa Code 135.144(3), and in conjunction with the Iowa Department of Public Health, unless otherwise modified by subsequent proclamation or order of the Iowa Department of Public Health, I continue to order that until this disaster proclamation expires:

  1. A hospital, outpatient surgery provider, or outpatient procedure provider may conduct in-patient surgeries and procedures that, if further delayed, will pose a significant risk to quality of life and any outpatient surgeries or procedures if the hospital or provider complies with the following requirements:
  1. A hospital or provider must have:
    1. Adequate inventories of personal protective equipment (PPE) and access to a reliable supply chain without relying on state or local government PPE stockpiles to support continued operations and respond to an unexpected surge in a timely manner; and
    2. A plan to conserve PPE consistent with guidance from the CDC and Iowa Depm1ment of Public Health;
  2. A hospital or provider must have a plan for timely COVID-19 testing of symptomatic patients and staff to rapidly mitigate potential clusters of infection and as otherwise clinically indicated. Providers must comply with any relevant guidance related to testing requirements for patients and staff issued by the Iowa Department of Public Health, the CDC, or a provider’s professional specialty society. For scheduled surgeries patients should have a negative COVID-19 test performed within 72 hours of surgery date. If a COVID-19 test is not available, a hospital or provider should consider alternative methods to determine the patient’s probability of COVID-19. If the patient has symptoms of fever, cough, or low oxygen saturation, then postponing the surgery is recommended.
  3. A hospital must continue to accept and treat COVID-19 patients and must not transfer COVID-19 patients to create capacity for elective procedures.
  4. A hospital must reserve at least 10% of intensive care unit (ICU) beds and 10% of medical/surgical beds for COVID-19 patients.
  5. A hospital or provider that begins conducting surgeries or procedures as authorized by this paragraph but is no longer able to satisfy all these requirements must cease conducting such surgeries or procedures except as authorized by paragraph B. All hospitals and providers shall have a plan in place to monitor compliance and a transition plan to reduce or suspend procedures and surgeries as necessary.
  1. Except as provided in paragraph A, all nonessential or elective surgeries and procedures that utilize PPE must not be conducted by any hospital, outpatient surgery provider, or outpatient procedure provider, whether public, private, or nonprofit.
  2. A nonessential surgery or procedure is one that can be delayed without undue risk to the current or future health of a patient, considering all appropriate factors including, but not limited to any: (1) threat to the patient’s life if the surgery or procedure is not performed; (2) threat of permanent dysfunction of an extremity or organ system; (3) risk of metastasis or progression of staging; and ( 4) risk of rapidly worsening to severe symptoms.
  3. Each hospital, outpatient surgery provider, and outpatient procedure provider shall limit all nonessential individuals in surgery and procedure suites and patient care areas where PPE is required. Only individuals essential to conducting the surgery or procedure shall be present in such areas.
  4. Each hospital, outpatient surgery provider, and outpatient procedure provider shall establish an internal governance structure to ensure that the principles outlined above are followed.

SECTION ONE HUNDRED FIFTY-TWO. The provisions of this proclamation shall be effective immediately, unless otherwise noted. This state of public health disaster emergency shall now expire on November 15, 2020, at 11 :59 p.m., unless sooner terminated or extended in writing by me.

Clinical guidelines and codes

Code blue updates for patients with confirmed or suspected COVID-19
Updated on 10/12/2020 at 11:42 am

A new guideline for code blue for patients with confirmed or suspected COVID-19 has been outlined for our UI Health Care staff to follow, effectively immediately.

Code Blue Guideline for COVID-19 patients or PUI

  1. Cardiac arrest management for patients with either confirmed COVID-19 infection or PUI is a high-risk period for transmission to health care workers.
  2. Providers should proactively address goals of care of COVID-19 patients. In the event of cardiac arrest, the evidence is showing that the probability of a good outcome is poor, especially in critically ill COVID-19 patients. This information should be shared with the patient (or surrogate decision-makers) as it relates to the specific patient’s condition.
  3. If a patient enters cardiac arrest, follow current guidelines for your area (calling a code blue for inpatient and outpatient at main campus & calling 911 for offsite locations).
  4. While you wait for the response team to arrive follow the current American Heart Association Guidance:
    1. Cover your own mouth and nose with a face mask.
    2. Cover the patient’s mouth and nose with a face mask.
    3. Perform hands-only CPR.
    4. Use an AED/Defibrillator if available.
    5. Once the response team arrives, let them assume care of the patient and leave the room.
  1. The response team for COVID-19 cardiac arrest patients should be limited to only necessary personnel. Pharmacists will be available outside the room. Students are not to be allowed in to simply observe.
  2. All code blue response team members, during cardiac arrest, should adhere to airborne and contact isolation precautions. No Code Blue team member should enter the patient’s room without these precautions. The door should remain closed.
  3. Each member of the code team should carry his/her own properly-fit N95 mask.
  4. Limited supply (2 of each size of N95 and 8 face shields) will be brought to the code as back up. One set will be brought by HOM/nursing supervisor and one set will be on the defibrillator/monitor that is brought to the code.
  5. Appropriate donning and doffing procedures may delay routine cardiac arrest care. Providers will work expeditiously as best as they can, without compromising their safety. Isolation precautions and use of PPE are not different in COVID-19 confirmed patients or PUI.
  6. No unnecessary equipment should be taken into the patient’s room during cardiac arrest. The emergency medicine tray should be left outside the room. A pharmacist will assist with preparing and mixing drugs. A dedicated team member outside the room will serve as the liaison between the team leader in the room and the pharmacist outside the room, using closed loop communication.
  7. For intubated patients in ICUs who are being mechanically ventilated, respiratory therapists should expand alarm parameters and ventilation should continue with the standard mechanical ventilator (10 breaths/min). The ventilator circuit should not be broken unless evidence of equipment malfunction occurs. A viral/bacterial filter will be added to the expiratory arm by the respiratory therapist.
  8. For patients who are being bag mask ventilated (whether intubated or not), a viral/bacterial filter will be added by the respiratory therapist.
  9. After a cardiac arrest event, all equipment (such as defibrillator, etc.) should remain in the room for complete decontamination prior to placing back in service. Any patient who achieves ROSC should be transported to an ICU room using maximal contact and droplet precautions using standard institutional policy for COVID-19-positive patients (including use of security to clear hallways). The code team should discard their PPEs after the code and while in the room, and then wear new PPEs for patient transport.

Code green updates for behavioral emergencies

The Show of Support Team consists of a hospital security officer, BHS nurse leader (M–F, 7 a.m.–3 p.m.), and BHS SWOT/HOM (off shifts). Please see table below as a guide on when to call each team. Staff will dial 192 (on the back of the badge) and request either the Show of Support Team or the Code Green Team (a similar model to medical emergencies).

The Code Green and Show of Support Teams are available to units/services at UI Hospitals & Clinics. Off-site areas should follow their emergency management plan.

Patient Behavior Level of Response
  • Confused/delirious
  • Irritable (easily annoyed/angered)
  • Not following directions
Unit level response:

  • Notify nurse manager and/or charge nurse
  • Notify patient’s provider
  • Verbal threats to harm self or others
  • Impulsive (quick to over react)
  • Staff concerned patient will escalate further
Show of Support Team

  • Dial 192
  • Physical violence seems imminent
  • Property destruction
  • Elopement
Code Green Team

  • Dial 192

Frequently asked questions

What if I don’t need the SOS/Code Green Team but just need a psychiatric consult?

  • Psych Consult Services at pager #3322
  • Psych nurse daytime consult pager #7689
  • BHS SWOT nurse #3498

What if a visitor is having the behavioral emergency?

  • Contact Safety and Security, dial 195

What if my patient needs twice as tough restraints?

  • Call BHS units or HOM to have restraints sent to you:
    • 2JPW: 3-6155
    • 2JPE: 6-7736
    • HOM #3313

More information

COVID-19 NICU Guidelines
Updated on 05/07/2020 at 2:28 pm

COVID-19 NNSY Guidelines
Updated on 08/13/2020 at 7:46 am

Pediatric RRT and Code Blue Response
Updated on 05/18/2020 at 7:33 am

1. Resuscitation efforts will be carried out using standard procedures and protocols

2. Care will be taken to minimize the number of staff members and equipment entering the patient’s room.

  • Any provider and staff members (e.g., RT, RN) entering the room during a resuscitation will follow standard, contact and airborne precautions with eye protection given high likelihood of an aerosol-generating procedure. This means wearing a gown, gloves, N95 mask and face shield. Door will remain closed.
  • PICU Charge RN will bring a special COVID-19 filter for resuscitation bag and bag of back up PPE (8 face shields and 2 of each size N95 mask) to all RRT and Code Blue events.
  • Pediatric Senior Resident will bring a special COVID-19 filter for resuscitation bag and bag of back up PPE (8 face shields and 2 of each size N95 mask) to all RRT and Code Blue events. This will be stored in the Resident Workroom on Level 10. Resident must return this to L10 charge nurse who will should inventory, re-stock and replace bag in Resident Workroom on Level 10 after use (directions inside bag).
  • Intubation should be performed by the most experienced provider available. Awake fiberoptic intubation should be avoided.  Perform a rapid sequence induction to avoid manual ventilation.  Laryngoscopes should be sheathed immediately post-intubation and all used airway equipment will be sealed in a zip-locked plastic bag.
  • Medication tray should be left outside the room.
Peds RRT for NON COVID-19 PUI or positive patient

Responders who should enter the room:

  • Senior Pediatric Resident
  • Staff Physician for the patient
  • Bedside RN
  • Additional Floor RN
  • RT
  • PICU Charge RN

** Floor Charge RN to direct traffic but does not need to enter room unless there is clinical necessity

Peds RRT for COVID-19 PUI or positive patient

Responders who should enter the room

  • Senior Pediatric Resident or Fellow or Staff Physician (i.e, the most experienced available clinician
  • Bedside RN
  • Additional Floor RN
  • RT
  • PICU Charge RN
  • Peds anesthesia faculty (#6626) will get the page as FYI

** Floor Charge RN to direct traffic but does not need to enter room unless there is clinical necessity

Peds Code Blue* for NON COVID-19 PUI or positive patient

Responders who should enter the room:

  • PICU fellow / faculty (will serve as team leader)
  • Senior Pediatric Resident
  • Bedside RN
  • Additional Floor RN (this might be the Floor Charge RN)
  • RT
  • PICU Charge RN
  • Anesthesia On-Call for airway
  • Peds anesthesia faculty (#6626)
  • Individuals performing chest compressions, if needed
Peds Code Blue* for COVID-19 PUI or positive patient

Responders who should enter the room:

  • PICU fellow / faculty (will serve as team leader)
  • Senior Pediatric Resident or Fellow or Staff Physician (i.e, the most experienced available clinician
  • Bedside RN
  • Additional Floor RN (this might be the Floor Charge RN)
  • RT
  • PICU Charge RN
  • Anesthesia On-Call for airway
  • Peds anesthesia faculty (#6626)
  • Individuals performing chest compressions, if needed

*Additional responders who are needed for a Code Blue but should not enter the patient’s room include:

  • Floor / Charge RN to direct traffic
  • RN to assist with preparing medications
  • RT Supervisor and CWS House Operations Supervisor (HOM)
  • All other typical Code Blue responders
Hyperbaric COVID-19 Protocol for the Treatment of Emergency Cases
Updated on 05/20/2020 at 10:47 am

PURPOSE: Description of work flow alterations in an effort to mitigate the spread of infection within the hyperbaric facility when caring for emergent cases and/or incidences involving two or more patients, in addition to suspected Covid 19 patients. This patient population includes those receiving emergency related treatment.

TARGET POPULATION: Hyperbaric staff, patients, physicians, and the physical facility

DEFINITIONS: None

CRITERIA:

CLINICAL ASSESSMENT/SCREENING:

A. Patients that meet the inclusion criteria to receive hyperbaric treatmet will be assessed daily with the following methods.

  1. Upon arrival to the facility and if able, each patient will be screened for new or worsening cough, fever, or sore throat. Clinical presentation will provide a secondary observation if the patient is displaying Covid like symptoms and unable to verbally respond to these questions.
  2. Patient temperatures will be taken daily and documented in EPIC.

DOCUMENTATION REQUIREMENTS:

A. Covid-19 prescreening will be documented in EPIC in accordance with hospital guidelines.

PRECAUTIONS, CONSIDERATIONS, AND OBSERVATIONS:

A. Facility Preparedness

  1. The chamber will be disinfected between each treatment by the hyperbaric staff with an approved disinfecting agent recommended by Perry Baromedical.
  2. Hyperbaric equipment including recliners, chairs, pillows, IV poles, ventilators, and patient monitors will be cleaned with an approved disinfectant agent between each treatment.
  3. The dressing rooms will be disinfected with a hospital supplied approved cleaning agent between each patient use.
  4. Patient equipment in the form of hoods or masks will be disinfected between each treatment and stored separately in a sealed bag on a labeled shelf.

B. Patient requirements

  1. All patients will don a surgical mask upon entering the facility and be asked to wash their hands and/or use hand sanitizer.
  2. As required to participate in a hyperbaric treatment, the patient will change into approved 100% HBO cotton scrubs.
  3. After changing clothes, patients will either wash their hands or use hand sanitizer.
  4. Vital signs will be performed and documented in EPIC. Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be taken before the patient enters the chamber.
  5. The patient will be allowed to use a surgical mask during the compression phase of the dive. This accommodation allows access to their nose to facilitate a Valsalva maneuver to prevent ear barotrauma.
  6. If the patient is intubated, Covid isolation guidelines established by the Respiratory Care department will be followed.
  7. Once treatment depth has been reached, each patient will remove their surgical mask and don their HBO approved oxygen hood.
  8. The hood will remain on the patient for the duration of the treatment including decompression. This action effectively isolates each patient from the chamber environment.
  9. If a patient hood needs to be removed for any reason, the patient will immediately don their surgical mask. Hood breaches will be kept to a minimum.

C. Staff requirements

  1. Each attendant will abide by the Respiratory isolation guidelines established by the hospital, CDC, and the Undersea & Hyperbaric Medical Society during this Covid 19 crisis.
  2. A face shield, N95 mask, isolation gown, and gloves will always be worn by the HBO attendant at all times.
  3. Hand sanitizer will be used between each patient contact encounterand as per our hand hygiene policy.
  4. Gloves will be donned and doffed between patients

D. Patient load

  1. Up to six patients can be treated at the same time if from the same household.
  2. In the event multiple emergent cases arrive simultaneously and the patients are not from the same household up to 2 patients will be treated at the same time in order to maintain social distancing provided both patients can be seated. If one or both patients require a bed for treatment, only 1 will be treated at a time.
  3. Efforts will be made to triage patients based on clinical presentation.
  4. A risk assessment to patient and attendant safety will be made on a case by case basis.

E. Safety

  1. We will continue our regular practice and use of approved dive tables based on the presenting illness of each patient.

REFERENCES:

Dr. Merete Ibsen – Medical Director

Mike Holder – Safety Director

Clinical Care Guidance for Healthcare Professionals about Coronavirus (COVID-19). (2020, May 3). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care.html

Guidelines for infection control, patient treatment, and staff safety considerations related to Hyperbaric Oxygen Therapy (HBO2) in monoplace and multiplace hyperbaric chambers during the novel coronavirus disease (COVID-19) outbreak. March 2020

APPROVED BY: Medical Director and Respiratory Care Director

Source: Department of Respiratory Care

Effective Date: 5/8/2020

Version Number: 1

Hyperbaric COVID-19 Protocol for the Treatment of Elective Cases
Updated on 06/01/2020 at 5:28 pm

PURPOSE

Description of work flow alterations in an effort to mitigate the spread of infection within the hyperbaric facility when caring for elective cases. This patient population includes those receiving scheduled daily treatments.

TARGET POPULATION:

Hyperbaric personnel, patients, and the physical facility.

CLINICAL ASSESSMENT/SCREENING:

  1. Patients that meet the inclusion criteria to receive hyperbaric treatment will be assessed daily with the following methods.
    1. Upon arrival to the facility, each patient will be screened for new or worsening cough, fever, or sore throat.
    2. Patient temperatures will be taken daily and documented in EPIC.

DOCUMENTATION REQUIREMENTS:

  1. Covid-19 prescreening will be documented in EPIC in accordance with hospital guidelines.

PRECAUTIONS, CONSIDERATIONS, AND OBSERVATIONS:

  1. Facility Preparedness
    1. The chamber will be disinfected between each treatment by the hyperbaric staff with an approved disinfecting agent recommended by Perry Baromedical.
    2. Hyperbaric equipment including recliners, chairs, pillows, IV poles, ventilators, and patient monitors will be cleaned with an approved disinfectant agent between each treatment.
    3. The dressing rooms will be disinfected with a hospital supplied approved cleaning agent between each patient use.
    4. Patient equipment in the form of hoods or masks will be disinfected between each treatment and stored separately in a sealed bag on a labeled shelf.
  2. Patient requirements
    1. All patients will don a surgical mask upon entering the facility and be asked to wash their hands and/or use hand sanitizer.
    2. As required to participate in a hyperbaric treatment, the patient will change into approved 100% HBO cotton scrubs.
    3. After changing clothes, patients will either wash their hands or use hand sanitizer.
    4. Vital signs are performed every Monday and Thursday. This includes heart rate, respiratory rate, blood pressure, O2 saturation, and temperature. The remaining days will be limited to checking temperatures only (Tues, Wed, Fri).
    5. The patient will be required to use a surgical mask during the compression phase of the dive. This accommodation allows access to their nose to facilitate a Valsalva maneuver to prevent ear barotrauma.
    6. Once treatment depth has been reached, each patient will remove their surgical mask and don their HBO approved oxygen hood.
    7. The hood will remain on the patient for the duration of the treatment including decompression. This action effectively isolates each patient from the chamber environment.
    8. If a patient hood needs to be removed for any reason, the patient will immediately don their surgical mask.
  3. Staff requirements
    1. Each attendant will abide by the droplet isolation recommendations provided by the hospital during this Covid 19 crisis.
    2. A face shield, surgical mask, and gloves will always be worn by the HBO attendant.
    3. Hand sanitizer will be used between each patient contact encounter.
    4. Gloves will be donned and doffed between patients
  4. Patient load
    1. We will limit our capacity to 2 patients per treatment until social distancing practices subside.
    2. With 2 patients and 1 attendant, the approved 6-foot social distancing recommendation can be effectively implemented.
  5. Safety
    1. We will continue our regular practice and use of approved dive tables based on the presenting illness of each patient.

REFERENCES:

Dr. Merete Ibsen – Medical Director

Mike Holder –Safety Director

Clinical Care Guidance for Healthcare Professionals about Coronavirus (COVID-19). (2020, May 3). Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-      care.html

Guidelines for infection control, patient treatment, and staff safety considerations related to Hyperbaric Oxygen Therapy (HBO2) in monoplace and multiplace hyperbaric chambers during the novel coronavirus disease (COVID-19) outbreak. March 2020

 

APPROVED BY: Medical Director and Respiratory Care Director

Source: Department of Respiratory Care
Effective Date: 5/8/2020
Version Number: 1
Date Revised:
Date Reviewed:
COVID-19 management for psychiatric patients
Updated on 07/27/2020 at 7:59 am

Clinical processes and workflows

Alaris IV Infusion Pumps Located Outside Patient Rooms for COVID-19 Positive Adults
Updated on 04/17/2020 at 9:20 am

PROTOCOL TEMPORARILY CREATED PURSUANT TO AUTHORITY OF HOSPITAL INCIDENT COMMANDER ACTIVATED IN RESPONSE TO COVID-19. EFFECTIVE UNTIL FURTHER NOTICE.

Date Created Per HICS: 4/02/2020                                                             Date Amended Per HICS: (4/16/2020)

Purpose: To minimize personal protective equipment (PPE) utilization, decrease PPE doffing risks and maintain medication infusion safety. The decision to implement this policy will be made by the unit leadership (Nurse Manager and Medical Director) on a unit by unit basis due to staff education requirements and unique circumstances on each patient care unit.

Policy: For patients with a confirmed COVID-19 infection, an Alaris IV infusion pump located outside the patient’s room may be utilized for administration of continuous infusions or intravenous fluids. The decision to use this plan shall be made in conjunction with the treatment team and nursing.

General procedures for inpatient care units and the ILI Clinic:

A. Inpatients should be able to be easily visualized if this process is utilized. This can include glass doors or use of the Video Monitoring Unit (Note- the VMU is to be used as a supplemental monitoring resource dedicated to ensuring the nursing staff is aware of any activity by the patient that may affect the IV infusion, such as ‘picking’ at the lines.)

B. Direct visualization or VMU is not required for patients receiving IV fluids (D5, NS etc…) in the ILI clinic.

C. An Alaris IV infusion pump located outside of the patient’s room may be utilized for peripheral or central administration of continuous infusions or intravenous fluids

D. Extension tubing shall be attached to the Alaris IV infusion pump

  1. If utilizing tubing sets instead of or in addition to extension tubing, ports on tubing sets should not be used to administer medications
  2. IV extension tubing may be used for the same amount of time as other IV tubing
  3. Position patient in the room so that the least amount of IV extension tubing is used
  4. Keep IV tubing off the floor
  5. Care should be taken to secure IV tubing and connection sites

E. Nursing staff shall verify the IV line to be used for a given infusion prior to initiating medication administration

  1. Frequency of site checks (N-07.001)
    • Peripheral IV and Midline Catheter, non-infusing: every 24 hours
    • Peripheral IV and Midline Catheter, infusing: every 4 hours
    • Central Venous Devices, non-infusing: every 24 hours
    • Central Venous Devices, infusing: every 12 hours

F. A patient specific barcode shall be attached to the Alaris IV infusion pump located outside the patient’s room

G. A dark-colored bag shall be placed over any IV medication hung outside a patient room to protect patient information

H. Care should be taken to ensure that power cords are secured and not a trip hazard and not on the floor

I. The correct electrical connection outlet devices are located on the IV poles used for the Alaris pumps. Extension cords are temporarily authorized for this use and will be extended for the duration of the HICS COVID-19 event.

J. No restrictions regarding which continuous infusions or intravenous fluids may be run by nursing staff using an Alaris IV infusion pump located outside the patient’s room. This including but not limited to:

  1. High-alert medications (MM.7-1)
  2. Titratable continuous infusions

K. IV push medications will be done inside the patient’s room

L. Intermittent infusion will be infused via an Alaris Infusion Device located inside the patient’s room

M. Ensure that when connected to a central line, that lumens are either infusing or saline locked to avoid occlusion. Don’t shut off the pump and forget to saline lock when you are done with the lumen.

Mechanically ventilated patients who cannot be directly visualized from outside the patient room when the door is closed and are not on video monitoring:

A.Nursing staff may not administer any continuous infusions or intravenous fluids using an Alaris IV infusion pump located outside the patient’s room

B. All IV medications shall be administered using an Alaris IV infusion pump located inside the patient’s room

 Considerations during patient transport

A. Limit the number of disconnections/reconnections of IV extension tubing

B. Check that all medical devices are secure

C. Consider use of a clean disposable chux or clean pillowcase to place IV tubing in patient bed

COVID-19 Positive Patient Discharge Process
Updated on 04/20/2020 at 1:15 pm

The process outlined below is to be used for the discharge of all COVID-19 positive patients.  This process has been developed with collaboration from a multi-disciplinary team and approved through the HICS structure.

  • Once decision to discharge the patient has been confirmed, nursing will work with the patient and/or the responsible party picking up the patient to identify an approximate discharge time.
    • Note: COVID-19 positive patients cannot have visitors and are not to be waiting for ride outside of their room. All efforts should be made to prioritize any possible discharge barriers and to complete paperwork in a timely manner to make identified discharge time. Nursing’s intent is to limit the wait time of the patient’s ride and to limit the time the COVID positive patient spends in public areas.
    • It is strongly recommended that patients fill their discharge prescriptions at the UIHC Discharge Pharmacy to minimize community spread. Prescriptions should be sent electronically to the Discharge Pharmacy. Pharmacy staff will call the patient’s room to counsel the patient, and the prescriptions will be sent up to the patient’s room.

 

  • Nursing staff will perform discharge and documentation per usual method, ensuring patient receives and verbalizes understanding of COVID-19 discharge instructions.
  • Nursing will request “patient transport” via EPIC. Nursing will include “COVID-19 positive”, or similar language in comment section of request to alert transporter to take appropriate precautions.
    • Note: Patient transport request will be placed only after it is determined patient’s ride is on hospital grounds and waiting at designated pickup location.

 

  • Nursing staff will take wheelchair into patient’s room, prepare patient for discharge (e.g. transfer them into the wheelchair with belongings) while wearing droplet, contact and eye protection PPE.
  • When transportation staff arrives to unit, nursing will cover the patient with a clean sheet, place surgical mask on patient, clean handles of wheelchair with approved disinfectant per manufacturer’s guidelines* and communicate to transportation staff that patient is COVID-19 positive.
  • Transporter needs to wear a surgical face mask and eye protection, clean gloves should be stored in transporter’s pocket.  Additional PPE is not required unless other medical assistance resulting in physical contact (i.e. Assist in patient transfer) is required.
    • For infants / young toddlers the parent / guardian may sit in the wheelchair and hold onto their child for the transport off the unit.
    • For older children / adolescents then the patient should be in the wheelchair but there may be a parent / guardian present for transport off the unit as well.
  • If assistance or physical contact will be needed, two transporters will accompany the patient.  One transporter will wear a surgical face mask and eye-protection and does not wear gloves.  This person will open doors, activate elevator buttons, etc.  The second transporter will wear droplet, contact and eye protection PPE; this person will provide assistance to the patient.
  • Under no circumstances should anyone wearing gloves touch door handles, doors, elevator buttons, etc.
  • Patient will be transported to designated exit via mode-of-transportation as identified by Guest Services. If applicable, Guest Services will contact Safety and Security at #6-2658 for access to designated exit.
    • Adult patients – W194 near Ramp 1
    • Adult patients – 1940X near South JPP
    • SFCH patients – SFCH Main Entrance
    • NICU/NNSY patients – 1940X near South JPP
  • Once transport is complete, transporter will put on gloves and:
    • Place sheet in routine linen hamper
    • Thoroughly wipe wheelchair down with approved disinfectant per the manufacturer’s guidelines*
    • Remove PPE except face shield and perform hand hygiene
    • Return the wheelchair for patient use
      • PPE, linen hamper and disinfectant will be stored in the Guest Services area near West GH entrance for adult patients
      • PPE, linen hamper and disinfectant will be stored in the Guest Services area near SFCH Main Entrance for SFCH patients

Note: If transport must hand patient off to valet staff, valet staff need to wear a surgical face mask and eye protection. If providing medical assistance or making physical contact with the patient (i.e. Assist patient to transfer) droplet, contact and eye protection PPE are needed. Valet staff will follow same disposal and cleaning instructions as described above.

*Per Manufacturer’s guidelines, thoroughly wipe the surface with approved disinfectant and ensure the area is wet and allowed to air dry.

** Droplet Precautions PPE: surgical face mask, gloves

** Contact Precautions PPE: isolation gown, gloves

** Eye Protection: face shield, goggles or mask with fluid shield

Discontinuation of Isolation Precautions for Patients with COVID-19
Updated on 12/15/2020 at 8:44 am
Discontinue COVID-19 Isolation Precautions Asymptomatic, mild, or moderate COVID-19 related symptoms (must meet all criteria):

  1. At least 10 days since symptoms first appeared (or positive test if asymptomatic)
  2. At least 24 hours with no fever (without fever-reducing medication)
  3. Symptoms have improved

Severe COVID-19 related illness or advanced immunosuppression (must meet all criteria):

  1. At least 20 days since symptoms first appeared (or positive test if asymptomatic)
  2. At least 24 hours with no fever (without fever-reducing medication)
  3. Symptoms have improved

Page the Program of Hospital Epidemiology; 3158 with questions or for additional guidance.

Patients who have previously tested positive for COVID-19 in the past 90 days should not be routinely re-tested if new symptoms develop. Re-testing could be considered if symptoms are highly specific for COVID-19 (loss of taste or smell with fever or respiratory symptoms) AND the patient had a recent high-risk exposure (within 6 feet of a person with lab confirmed COVID-19 for more than 15 minutes without the source person wearing a face covering during the source person’s infectious period). Patients with symptoms and a high-risk exposure should be tested ASAP and again on day 7-10 of quarantine if they present on day 1-5 post exposure.  If a patient with symptoms and a high-risk exposure presents on day 6-14 post exposure, they should only be tested one time, ASAP.

Patients with a previous positive COVID-19 test in the past 90 days who have had a high-risk exposure and are currently asymptomatic do not need to quarantine and retesting is not recommended.

Patients with a previous positive COVID-19 test in the past 180 days (counted from the first positive test) should not be retested prior to undergoing pre-procedure asymptomatic screening with a COVID-19 PCR test. Similarly, hospitalized patients without a known high-risk COVID-19 exposure who do not have COVID-19 symptoms and have had a previous positive COVID-19 test in the past 180 days (counted from the first positive test) should not be retested upon admission or routinely throughout their hospital stay.

Adult Overflow into UI Stead Family Children's Hospital During COVID-19 Pandemic
Updated on 06/01/2020 at 5:31 pm

Notary Process for COVID-19 Patients
Updated on 05/21/2020 at 3:50 pm

At this time, notaries will continue in-person visits to UIHC patients as needed.  The current process for notaries in non-COVID rooms will remain unchanged.  The proposed process (below) will go into effect only for COVID positive patients or patients awaiting COVID test results who require notary services.

  1. Notary (or two witnesses) will wear proper PPE to access unit. Notary will sign appropriate form outside the patient room and use window or open door to view patient.
  2. RN staff working with patient will take the signed paperwork from notary and a Voalte phone with Haiku access into the patient’s room.
  3. Patient will sign the paperwork while notary/witnesses observe from doorway.  Paperwork will remain in the patient room and accompany patient when transferred or discharged.
  4. RN staff will take a picture of each page of the signed document using the Voalte phone and Haiku application.
  5. Social Work staff will send email to Health Information Management at brooke-zittergruen@uiowa.edu and karen-r-kelly@uiowa.edu. HIM will ensure all document photos are combined into a single PDF and uploaded into the patient’s file in Epic (in media tab).

Unit Voalte phones are the primary technology for this process.  Any requests for additional applications or usage must go through HICS.

Workflow to Administer Monoclonal Antibody Therapy to Non-Hospitalized Patients
Updated on 11/23/2020 at 12:41 pm

ILI Clinic/Telemedicine

ILI Respiratory Clinic – Treatment Visit
Updated on 12/21/2020 at 1:29 pm

Patients diagnosed with COVID-19 who are undergoing telemedicine home monitoring by the Hospitalist team (HTT) and ILI Respiratory Telemedicine team deemed to need in person evaluation (see Ambulatory Monitoring of COVID Patients) will be seen via this workflow and under these clinical practice guidelines.

ILI Respiratory Clinic Treatment Visit Clinical Workflow and Clinical Practice Guidelines

  • Schedulers give patients instructions about location of appointment who to contact upon arrival.
  • Voalte log-ins for the treatment team. If you are assigned to the treatment team make sure to log into these when you arrive for your shift:
    • ILI Primary Care Nurse
    • ILI Primary Care Provider
  • Workflow at Management Check in:
    • Patients will call 319-678-4107 (directs to the ILI Primary Care Nurse) when they arrive.
    • Answer the phone with “ILI Respiratory Clinic. How can I help you?”
    • Get the patient’s name and DOB. Ask them where they are parked.
    • The nurse or paramedic will exit the clinic to pick up the patient from their vehicle.
  • Workflow for Providers with Clinical Practice Guidelines:
    • Vitals obtained and physical exam conducted by nursing staff and provider. Use clinical judgement, but consider these guidelines:
      • If patient is in respiratory distress (RR > 24 or inability to speak in full sentences or persistent O2 sat < 92% on 3 Liters NC) or with unstable vitals (hypotensive) —> ED transfer for stabilization, triage, and disposition decision
      • If 02 on room air is <92% —> Administer O2 via nasal cannula to keep SpO2 > 92% —> If O2 requirement is stable with < 3L O2 NC, and no respiratory distress or tachypnea > 24 RPM —> Direct admission
      • If concern for fluid overload on auscultation —> Consider CXR
      • If wheezing on lung exam or history of asthma/COPD —> albuterol MDI (preferably with patient’s home MDI)
    • Assess for history of heart failure or QTc prolongation
    • IV placed and blood drawn and sent for BMP (Utilize ILI: RESPIRATORY ILLNESS CLINIC ORDERS Smart Set —> Treatment —> IV Fluids)
    • Assess for nausea
      • Zofran 4 mg ODT or IV push
      • Obtain EKG if history of QTc prolongation.  Ensure QTc is <470 ms before administering Zofran
    • Review labs
      • If Cr > 1.8 mg/dL with no history of CKD —> Admission
      • If Cr > 0.5 mg/dL above baseline Cr if history of CKD —> Admission
      • If Na < 125 mEq/L or > 148 mEq/L —> Admission
      • If K < 2.5 mEq/L —> Admission
    • Replace potassium if needed
      • If K 2.5 – 3.4 mEq/L —> 40 mEq KCl liquid
    • Administer IV Fluids (LR or NS) – caution if later in course of illness (Day 7+) and concern for respiratory distress
      • 1000 cc bolus
      • 500 cc and re-evaluate for consideration of another 500 cc if history of CHF or concerns of fluid overload on CXR
    • If patient previously unable to keep down fluids secondary to nausea, can PO challenge with water or clear liquids.  If patient fails PO challenge and has intractable vomiting/nausea precluding adequate home hydration —> Direct admission
    • If patient continues to show signs/symptoms of dehydration after 1 L of IV fluids —> Direct admission

Contact General Medicine Triage Officer (pager 5025) to discuss direct admission. If direct admission is accepted, provider will place admission bed request order.

Transportation to Main Hospital from ILI Respiratory Clinic

  • Patient is a direct admit to 4 South or 5 South (general medicine/COVID unit) at UIHC
    • Call Johnson County non-emergency dispatch number (319-356-6800)
  • Patient needs to be transferred to ED non-emergently (319-356-6800)
    • Call Johnson County non-emergency dispatch number
  • Patient is unstable and needing transferred to the ED
    • Call 911
  • If patient declines ambulance transfer and chooses to go by private vehicle then the admitting floor and the Emergency Department both need to be notified prior to the patient leaving the clinic.
    • The patient will check-in through the Emergency Department. The admitting floor staff will be responsible for transporting the patient from the Emergency Department to the admitting floor.
ILI Respiratory Clinic Workflow for COVID Results
Updated on 03/16/2021 at 7:57 am

1.All COVID-PCR test results will be released to MyChart within 60 minutes of completion.

  • Includes positive and negative results for LAB8963, LAB9023, LAB8978

2. Positive results-Symptomatic or High Risk Exposed Patients

  • Discuss release from isolation guidelines: Fever free x 24 hours without the use of fever reducing meds PLUS symptoms improving PLUS at least 10 days since onset of symptoms.
  • ILI Respiratory Clinic provider reviews result in EPIC Results Inbasket and contacts patient via telephone during business hours. Discuss the following and document in EPIC using .COVIDRESULTSPHONECALL:
    • Self-isolation (see .COVIDPTINSTSUSPECTEDORCONFIRMED).
    • Quarantine and 7 day post exposure testing for high-risk close contacts.
    • Home treatment team (HTT) RN will contact patient next day to discuss home monitoring program.
    • Verify address and delivery instructions for home monitoring kit (apartment number, floor, access code, preferred door to drop off kit).

3. Positive results – Pre-operative/procedure testing for Asymptomatic Patients

  • Surgical/procedure team to contact patient with next steps regarding upcoming procedure.
  • ILI Respiratory Clinic provider will contact patient during business hours to review self-isolation, quarantine, and home treatment team information.

4. Negative results- Symptomatic Patients without high risk exposure

  • Recommend self-isolation until fever free x 24 hours without the use of fever reducing medications.
  • ILI Respiratory Clinic provider reviews results in EPIC Results Inbasket
  • If patient has MyChart, provider sends patient a MyChart message using smartphrase:
    • COVIDMCNEGSYMNONEXPOSED
  • If patient does not have MyChart, provider sends a result note to the P ILI RESPIRATORY ILLNESS NURSE pool.  The provider documents specific instructions to be communicated.
    • Clinical staff members will make 1 attempt to provide results.  If no answer, will send UIHC: INFLUENZA LIKE ILLNESS RESULTS LETTER àCOVID Negative (Symptomatic)

5. Negative Results – Symptomatic Patients with high risk exposure

  • Patients with symptoms and a high-risk exposure should be tested ASAP and again on day 7-10 of quarantine if they present on day 1-5 post exposure.  If a patient with symptoms and a high-risk exposure presents on day 6-14 post exposure, they should only be tested one time, ASAP.
  • Recommend self-isolation until fever free x 24 hours without the use of fever reducing medications.
  • ILI respiratory clinic provider reviews result in EIPC Results Inbasket
  • If patient has MyChart, provider sends patient MyChart message using smartphrases:
    • .COVIDMCNEGSYMEXPHCPNONESSENTIALCRITICAL
    • .COVIDMCNEGSYMEXPESSENTIALCRITICAL
  • If patient does not have MyChart, provider sends a result note to the P ILI RESPIRATORY ILLNESS NURSE pool.  The provider documents specific instructions to be communicated.
    • Clinical staff members will make 1 attempts to provide results.  If no answer, will send UIHC: INFLUENA LIKE ILLNESS RESULTS LETTER à COVID Negative (Symptomatic) – Exposed Healthcare personnel, Non-Essential/critical worker OR COVID Negative (Symptomatic) – Exposed; Essential/Critical Worker.
    • If patient answers and is still having symptoms, clinical staff can Order Follow-Up Appointment if needed
    • If symptoms still present, schedule patient follow up video visit in 1,2, or 3 days depending on severity of symptoms and whether additional work-up is needed.
    • Use FOL159 (FOLLOW UP- ILI Telemedicine).  Return Reason: COVID negative, follow up for symptom resolution or FOL145 (FOLLOW UP PCP), or arrange follow-up in QuickCare or Urgent noting patient has been “Cleared for COVID.”
    • Instruct patient that if they wish to cancel their appointment to contact scheduling at 1-319-384-9010.
    • If patient answers and symptoms have resolved or are significantly improved, no additional follow up needed

6. Negative Results – Exposed Asymptomatic Patients

  • The Iowa Department of Public Health recommends that persons with a high-risk exposure to a person with COVID-19 complete a 14 day in-home quarantine if possible.  However, if a 14-day quarantine cannot be completed, there are options for early release from in-home quarantine:
    • Early release after 7 days of in-home quarantine may be considered if a person remains without symptoms and has a negative test on or just before the 7th day.  However, during the remaining 7 days of quarantine, the person must:
      • Continue to monitor for symptoms of COVID-19
      • Wear a face mask at all times
      • Maintain social distance
      • Follow all other safety measures recommended by public health
    • Early release after 10 days of in-home quarantine may be considered if a person remains without symptoms without any testing.  However, during the remaining 4 days of quarantine, the person must:
      •  Continue to monitor for symptoms of COVID-19
      • Wear a face mask at all times
      • Maintain social distance
      • Follow all other safety measures recommended by public health
  • ILI Respiratory Clinic provider reviews results in EPIC Results Inbasket
  • If patient has MyChart, provider sends patient a MyChart message using smartphrases:
    • .COVIDMCNEGASEXPHCPNONESSENTIALCRITICAL
    • .COVIDMCNEGASEXPESSENTIALCRITICAL
  • If patient does not have MyChart, provider sends a result note to the P ILI RESPIRATORY ILLNESS NURSE pool.  The provider documents specific instructions to be communicated.
  • Clinical staff members will make 1 attempt to provide results. If no answer, will send UIHC: INFLUENZA LIKE ILLNESS RESULTS LETTER àCOVID Negative High Risk Exposure.
    • If patient develops symptoms during COVID quarantine, they should schedule another telemedicine appointment to determine if symptomatic COVID testing is needed.

7. Negative results – Pre-operative/procedure testing for Asymptomatic Patients

  • Review to MyChart and done result.  Will not communicate result to patient via telephone.

8. Indeterminate Results – Indeterminate results from UIHC lab have been run twice and come back as a “low positive.” Patients with an indeterminate COVID-19 result will be treated as positive and instructed to isolate like any other COVID-19 positive patient. These patients will not be routinely retested.

  • The Iowa Department of Public Health does not consider these results to be positive and will not contact traced.
ILI Respiratory Telemedicine Scheduling Workflows
Updated on 04/17/2020 at 9:40 am

Adult workflow

Pediatric workflow

 

ILI Respiratory Clinic/Telemedicine Important Contacts
Updated on 11/23/2020 at 12:31 pm
Home Monitoring or ILI Respiratory Clinic Direct Admission Guidelines
Updated on 05/18/2020 at 7:38 am

1. Definition of services

  • Ambulatory and home monitoring of COVID positive patients, managed by:
    • HTT – Home Treatment Team consisting primarily of hospitalists
    • ILI Respiratory Telemedicine – home treatment team staffed by internists, pediatricians, and family medicine clinicians
    • ILI Respiratory Clinic Team – in person evaluation team staffed by internists, pediatricians, and family medicine clinicians.

2. Determination of appropriateness for direct admission

  • See document Criteria for Escalation of Care from Home Monitoring of COVID Positive or Suspected Patients

3. Protocol for direct admission to hospitalist COVID team via a telemedicine encounter

  • ILI Telemedicine or HTT provider will page the general medicine triage officer (patient >18 yo) or appropriate pediatric service to admit the patient to discuss the patient and the indications for admission
    • If both providers agree a direct admission is appropriate:
      • Referring provider places an admission bed request.
        • This can be done by going to Meds & Orders and entering “admission bed request”
          • Select the inpatient bed request
          • Referring clinic: ILI
          • Contact information: Enter your name and pager
          • Isolation: droplet, contact and eye protection
          • Admitting service: internal medicine (patient >18 yo) or appropriate pediatric service to admit the patient (patient <= 18 yo)
          • Attending service contacted: Select “yes” and then enter the General Medicine officer’s name or Pediatric COVID Hospitalist. This allows ATC to skip the triage process.
          • Complete the rest of the questions
      • This will trigger the admission transfer center (ATC) to find a bed for the patient.
      • ATC will contact the requesting provider for more information and to inform them when a bed is available.
    • If the medicine triage officer or contacted pediatric service provider recommends ED evaluation:
      • ILI Telemedicine or HTT provider will then call the ED, identify themselves and ask to speak to one of the ED staff about the patient.
      • The charge nurse will often answer first and take information about the patient to pass along to the ED staff
      • Discuss the patient with the ED staff, indicating why the hospitalist is concerned about admitting to the floor.
  • Protocol for patients arriving by private vehicle to the ED for either admission or evaluation:
    • Patient (and parent/legal guardian(s) if applicable) should be instructed to present to the main ED entrance.
    • Adult patients are not allowed visitors.
    • Instruct patient to arrive wearing a mask if patient is >2 yo. If they don’t have a mask, they should IMMEDIATELY notify screener or security that a mask is needed by calling the ED once they arrive at the main ED entrance.
    • If patient presenting for direct admission:
      • Screener will notify the ED Charge nurse that a patient has arrived for direct admission
      • ED Charge nurse will notify via Voalte the Med/Surg HOM for adult patients or the CWS HOM for pediatric patients
      • HOM will arrange for an escort to meet the patient at the ED an accompany them to the appropriate ward. This escort is responsible to be sure masks are kept on and in place.

4. Protocol for direct admission to adult hospitalist COVID team or appropriate pediatric service via in-person visit in the ILI Respiratory Clinic

  • ILI Respiratory Clinic provider will page the general medicine triage officer (patient >18 yo) appropriate pediatric service to admit the patient to discuss the patient and the indications for admission. See document ILI Respiratory Clinic – Treatment Visit.
  • If both providers agree a direct admission is appropriate:
    • Referring provider places an admission bed request.
      • This can be done by going to Meds & Orders and entering “admission bed request”
        • Select the inpatient bed request
        • Referring clinic: ILI
        • Contact information: Enter your name and pager
        • Isolation: droplet, contact and eye protection
        • Admitting service: internal medicine (patient >18 yo) or appropriate pediatric service to admit the patient (<= 18 yo)
        • Attending service contacted: Select “yes” and then enter the medicine triage officer’s name or Pediatric COVID Hospitalist. This allows ATC to skip the triage process.
        • Complete the rest of the questions
      • This will trigger the admission transfer center (ATC) to find a bed for the patient.
      • ATC will contact the requesting provider for more information and to inform them when a bed is available.
      • Patient escorted to receiving floor by ILI Respiratory Clinic staff. This escort is responsible to be sure masks are kept on and in place.
  • If the medicine triage officer or contacted pediatric service provider recommends ED evaluation
    • ILI Respiratory Clinic or HTT provider will then call the ED, identify themselves and ask to speak to one of the ED staff about the patient.
    • The charge nurse will often answer first and take information about the patient to pass along to the ED staff
    • Discuss the patient with the ED staff, indicating why the hospitalist is concerned about admitting to the floor.
    • Patient escorted to ED by ILI Respiratory Clinic staff. This escort is responsible to be sure masks are kept on and in place.
ILI COVID-19 Results Algorithm
Updated on 12/16/2020 at 8:19 am

ILI Clinical Pathway
Updated on 09/29/2020 at 10:42 am

ILI Donning and Doffing PPE
Updated on 10/16/2020 at 2:21 pm

ILI Telemedicine Epic Help FAQs
Updated on 11/12/2020 at 7:52 am

Home monitoring of COVID-19 positive patients

Ambulatory Monitoring of COVID Positive Patients
Updated on 11/04/2020 at 7:47 am

AMBULATORY PATIENTS (INCLUDING THOSE SEEN IN ED AND DISCHARGED TO HOME)

  1. COVID Risk 0-2 Peds and Adults
    • ILI (FOL159)
    • Asymptomatic or previously symptomatic but now asymptomatic
      • Patient seen in ILI Telemedicine/Respiratory Clinic
        • Encourage patient to call 319-384-9010 if they would like to schedule follow-up. If patient requesting follow-up, schedule them for last day of quarantine.
      • Patient seen in ED
      • Encourage patient to call 319-384-9010 if they would like to schedule follow-up. If patient requesting follow-up, schedule them for last day of quarantine. No kit
    • Mildly symptomatic
      • Definition
        • ILI Results Pool RN/Provider/ED Team judgment, but generally no more than 1-2 relatively benign symptoms (cough, URI sx). No dyspnea, fever, poor PO intake, etc
      • Patient seen in ILI Telemedicine
        • ILI Result Pool RN to place order for 3-5 day follow up depending on symptoms and risk factors.
      • Patient seen in ED
        • ED team member communicating results to place order for 3-5 day follow up depending on symptoms and risk factors.
      • No kit
    • Symptomatic
      • Definition
        • More serious symptoms (fever, dyspnea, diarrhea, poor PO intake, etc)
      • Patient seen in ILI Telemedicine/Respiratory Clinic
        • ILI Results Pool RN to place order for 2 day follow up.
      • Patient seen in ED
      • ED team member communicating results to place order for 2 day follow up.
      • Message pharmacy via email (HomeMonitoringKits@healthcare.uiowa.edu) to send limited kit*:
        1. Name/Initials
        2. MRN
        3. COVID Risk Score
        4. Specify limited kit
        5. Address
        6. Phone
        7. Special Delivery Instructions (such as leave at front door on black bench)
        8. Preferred language

2. COVID Risk 3+ Peds

    • ILI (FOL159)
    • Asymptomatic
      • Patient seen in ILI Telemedicine/Respiratory Clinic
        • ILI Results Pool RN to place order for 5 days post-positive test.
      • Patient seen in ED
        • ED team member communicating results to place order for 5 days post-positive test.
    • Mildly symptomatic or symptomatic
      • Patient seen in ILI Telemedicine/Respiratory Clinic
        • ILI Results Pool RN to place order for 1-day post-positive test.
      • Patient seen in ED
        • ED team member communicating results to place order for 1-day post-positive test.
    • Providers/ILI Results Pool RN/ED Team will determine if kit is necessary on case-by-case basis. (Full kits can only be sent to patients > 5 years old.)
      • If kit is necessary, message pharmacy via email (HomeMonitoringKits@healthcare.uiowa.edu) to send kit:
        1. Name/Initials
        2. MRN
        3. COVID Risk Score
        4. Specify full or limited kit**
        5. Address
        6. Phone
        7. Special Delivery Instructions (such as leave at front door on black bench)
        8. Preferred language

3. COVID Risk 3+ Adults

    • HTT (FOL161)
    •  Asymptomatic
      • Patient seen in ILI Telemedicine/Respiratory Clinic
        • ILI Results Pool RN to place order for 5 days post-positive test. If possible, avoid scheduling follow-up on Saturday/Sunday.
      • Patient seen in ED
        • ED team member communicating results to place order for 5 days post-positive test. If possible, avoid scheduling follow-up on Saturday/Sunday. If possible, avoid scheduling follow-up on Saturday/Sunday and tell patient to call 319-384-9010 to schedule an earlier test.
      • Message pharmacy via email (HomeMonitoringKits@healthcare.uiowa.edu) to send full kit**
        1. Name/Initials
        2. MRN
        3. COVID Risk Score
        4. Specify Full Kit
        5. Address
        6. Phone
        7. Special Delivery instructions (such as leave at front door on black bench)
        8. Preferred language
    • Mildly symptomatic or symptomatic
      • Patient seen in ILI Telemedicine/Respiratory Clinic
        • ILI Results Pool RN to place order for 2 day follow up (if next day follow-up needed, page 7576 to discuss). If possible, avoid scheduling follow-up on Saturday/Sunday and tell patient to call 319-384-9010 to schedule an earlier test.
      • Patient seen in ED
        • ED team member communicating results to place order for 2 day follow up.
      • Message pharmacy via email (Brenda Carmody, Courtney Gent, Lisa Mascardo) to send full kit**
        1. Name/Initials
        2. MRN
        3. COVID Risk Score
        4. Specify Full Kit
        5. Address
        6. Phone
        7. Special Delivery Instructions (such as leave at front door on black bench)
        8. Preferred language
    • Severely symptomatic or worsening
      • Page HTT team (7576) immediately to discuss a plan.

DISCHARGING INPATIENTS

  • Continued symptomatology OR <10 days since initial symptoms or positive test.
    • HTT (FOL161)
    • Discharging provider places order for 1 day follow up.
  • Bedside RN will arrange home monitoring kit to be delivered to the patient’s room prior to discharge.

 

*Limited kit= pulse ox, masks, nurse education packet

**Full kit= blood pressure monitor, pulse ox, masks, nurse education packet

COVID Risk Score Criteria and Stratification
Updated on 03/23/2021 at 10:31 am

ADULT (18+) COVID RISK SCORE CRITERIA AND STRATIFICATION

Medical history

  • Immunosuppression (2 points)
  • Currently receiving chemotherapy, history of bone marrow or solid-organ transplant, HIV
  • Active cancer/malignancy (1 point)
  • Cognitive Impairment or Developmental Disability (1 point)
  • Age (2 points possible)
    • <25 (-1 point)
    • 25-55 (0 points)
    • 55-69 (1 point)
    • >70 (2 points)
  • Congestive heart failure (1 point)
  • Coronary artery disease (1 point)
  • Hypertension (1 point)
  • Nursing home resident (1 point)
  • Chronic kidney disease (CKD) (2 points)
  • Chronic liver disease (1 point)
  • Pregnancy (2 point)
  • Chronic pulmonary disease (2 points possible)
    • Asthma (1 point)
    • Chronic obstructive pulmonary disease, Interstitial lung disease, cystic fibrosis, other chronic pulmonary diseases (2 points)
  • Diabetes (1 point)
  • Active tobacco use disorder (1 point)
  • Congenital hematologic disorders (2 points possible)
    • Sickle cell disease (2 points)
    • Thalassemia and others (1 point)
  • Cerebrovascular disease (1 point)
  • Overweight/obesity with a BMI (body mass index) >25 (2 points possible)
    • BMI 25-29.9 (overweight) = 1pt
    • BMI 30+ (obesity) = 2 pts
  • Race/Ethnicity = Hispanic or Latino, Black or African American, American Indian or Alaskan Native, and Native Hawaiian and other Pacific Islander people (1 point)

Score 0-2: ILI Respiratory Telemedicine Team

Score 3+: Home Treatment Team (HTT)

Criteria for Escalation of Care from Home Monitoring of COVID Positive or Suspected Patients
Updated on 04/17/2020 at 4:40 pm

Disposition options available:

1. Call EMS (911).

  • Use clinical judgement, but generally should be called with:
    • Unable to speak in full sentences.
    • Having concerning chest pain (particularly if non-pleuritic, exertional & relieved with rest, pressure-like).
    • Symptomatic hypotension: systolic BP <90 or a drop of 30 mmHg or more from baseline.
    • Syncope.
    • Cyanosis per family members.
    • Encephalopathy per family members.
    • Hypoxia: SaO2 <88%.

2. Same day appointment with ILI Respiratory Clinic for in-person evaluation. Patient can receive IV fluids, electrolytes, labs, imaging. Does not need direct admission or ED visit.

  • Use clinical judgement, but generally consider with:
    • SaO2 >92, but decreasing over the last few days (ex 98% —> 95% —> 93%).
    • Asymptomatic hypotension, pre-syncope, lightheadedness.
    • Inability to tolerate PO.
    • Profuse loose stools.
  • Place: FOL160 FOLLOWUP RESPIRATORY ILLNESS CLINIC à
    • PAC schedules patient to be seen same day for a 120min appointment .

3. Direct admission to the floor. If concern a patient requires ICU care, call EMS.

  • Use clinical judgement, but consider with:
    • Similar to criteria in 2a, but in clinical judgement warrants admission. The patient must be stable enough to facilitate admission over a few hours time frame.
    • Worsening dyspnea on exertion, but still able to speak full sentences.
    • Mildly increased O2 requirements (if on baseline O2), but again able to speak full sentences.
    • SaO2 88-92% and able to speak full sentences without respiratory discomfort.
    • Hypotension, but not having syncope.
ICC Triage Algorithm for Home Monitoring
Updated on 04/22/2020 at 8:00 am

Home Monitoring Kit Troubleshooting Guide
Updated on 04/30/2020 at 4:00 pm
Criteria for Initiating a Welfare Check on a COVID Positive Patient
Updated on 05/01/2020 at 4:00 pm

1. Purpose

  • Help our home-monitoring providers identify patients who qualify for a welfare check
  • Standardize the protocol for initiating a welfare check on COVI- patients

2. What is a welfare check?

  • A process in which a provider contacts local authorities asking them to physically check on patient because of a serious and imminent threat to the patient’s safety secondary to:
    • The patient being COVID-positive and as such, at risk for rapid respiratory decline and/or incapacitation
    • Attempts to contact the patient have been unsuccessful
    • An emergency contact is unable to verify the patient’s well-being

3. Who calls local authorities for a welfare check?

  • An ILI or HTT provider

4. Patient population

  • Patients unable to be reached for the initial enrollment phone call for home monitoring or for a scheduled home monitoring telemedicine appointment.
    • Patients diagnosed with COVID via testing in ILI clinic. Recommended by ILI provider for HTT management per established criteria, but HTT RN unable to contact patient for initial enrollment phone call. Provider also unable to reach patient the day after HTT nurse attempts intake.
      • Appropriate for welfare check if presence of serious and imminent threat to the patient’s safety.
    • Patients being actively home monitored by HTT or ILI Respiratory Telemedicine. These patients will have previously had a documented nurse encounter and/or a prior HTT or ILI Respiratory Telemedicine visit.
      • Appropriate for welfare check if presence of serious and imminent threat to the patient’s safety.
    • Patients seen and diagnosed with COVID via testing in the ED or discharged from an inpatient unit and known to be COVID positive, but HTT RN unable to contact patient for initial enrollment phone call. Provider also unable to reach patient the day after HTT nurse attempts intake.
      • Appropriate for welfare check if presence of serious and imminent threat to the patient’s safety.
    • Patients with positive COVID testing as ordered through employee health. Patient never previously seen for a home monitoring telemedicine visit. HTT RN unable to contact patient for initial enrollment phone call. Provider also unable to reach patient the day after HTT nurse attempts intake.
      • Appropriate for welfare check if presence of serious and imminent threat to the patient’s safety.

5. Protocol for initiating welfare checks

  • Patients diagnosed as COVID positive in ILI Respiratory Clinic, in the ED, or when discharged from an inpatient unit and known to be COVID positive:
    • Day 1- HTT RN attempts initial enrollment phone call for home monitoring:
      • Attempt 1
        • Voicemail left. RN explicitly states they will call back at specified time and provides a callback number for the patient to reach the HTT nurse. The HTT RN will leave their callback number for the day.
        • If the patient’s voicemail is full or not set up, HTT RN will move on to ‘attempt 2’.
      • Attempt 2
        • Voicemail left. RN explicitly states they will now call the emergency contact. Leaves callback number for patient to reach HTT nurse.
        • If the patient’s voicemail is full or not set up, HTT RN will attempt to reach emergency contact (see next step)
        • Attempt is made to reach emergency contact. Voicemail should be left stating we are trying to contact the patient. Leaves a callback number for the patient to reach the HTT nurse.
      • Attempt 3
        • Voicemail left on patient’s phone. RN explicitly states they will initiate a welfare check if unable to reach the patient the following day. Leaves a callback number for the patient to reach the HTT nurse.
        • A second attempt is made to reach emergency contact. Voicemail should be left stating we are trying to contact the patient. Leaves a callback number for the patient or emergency contact to reach the HTT nurse.
        • If the patient’s or emergency contact’s voicemail is full or not set up, there will be no message left for the patient or emergency contact.
        • HTT RN will document their 3 attempts to contact patient and 2 attempts to contact emergency contact, including the inability to reach both in EPIC.
        • RN places FOL161 (if HTT) or FOL159 (If ILI) order for next day follow up. This is the process in which the provider can initiate a welfare check.
    • Day 2- HTT Provider or ILI Telemedicine Provider
      • Attempt 1
        • Provider attempts to contact patient. If unable, considers whether welfare check is appropriate given patient’s risk factors for COVID complications, baseline level of health as evidenced in record review, acuity of illness based on documentation available in the medical record.
  • Patient actively home monitored by HTT or ILI Respiratory Telemedicine:
    • Note that if at any time, the provider has clinical concern there is a serious and imminent threat to the patient’s safety, a welfare check can be initiated irrespective of how many days or attempts have passed.
      • Clinical concern is based on patient risk factors for COVID complications, baseline level of health as evidenced in record review, acuity of illness based on previous home monitoring visit documentation.
    • Suggested timeline to initiate welfare check
      • Day 1
        • Attempt 1
          • Voicemail left. Provider explicitly states they will call back at specified time and provides ICC number on the voicemail (319-384-8819).
        • Attempt 2
          • Voicemail left. Provider explicitly states they will now call the emergency contact. Leaves ICC number.
          • Attempt is made to reach emergency contact. Voicemail should be left stating we are trying to contact the patient. Leaves ICC number.
        • Attempt 3
          • Voicemail left. Provider explicitly states they will initiate a welfare check if unable to reach the patient the following day.
          • Provider documents their attempt and inability to contact the patient in EPIC.
          • Provider places FOL161 (if HTT) or FOL159 (If ILI) order for next day follow up.
      • Day 2
        • Attempt 1
          • Provider attempts to contact patient. If unable, considers whether welfare check is appropriate given patient’s risk factors for COVID complications, baseline level of health as evidenced in record review, acuity of illness based on previous home monitoring visit documentation.

6. Initiating welfare check

  • Under “demographics” tab of EPIC, identify the patient’s address. Contact the non-emergent police line for that municipality.
  • Identify yourself and your role to the dispatcher. Ask for a welfare check secondary to concern for a serious and imminent threat to the patient’s safety. Explain that the patient is COVID positive so necessary precautions can be taken per their protocol.
  • Provide your contact information for a follow up (desk phone at your workstation or your personal cell phone preferred).
  • Document this information in the chart using EPIC Smart Phrase .COVIDWELFARE

7. Preventing welfare checks

  • Provider or clinical staff contacting ambulatory patient with COVID-positive results will notify patient that an RN from the HTT team will be contacting them the next day and discussing that a repeated inability to contact them via phone may ultimately result in a welfare check with local authorities.
    • Suggested documentation
      • “Explained to patient that if we are unable to contact them after multiple attempts to both them and their emergency contact, we may initiate a welfare check with the local authorities. Instructed the patient to keep their phone on them at all times.”
    • HTT RN obtaining consent for enrollment in the home monitoring program will communicate this policy to the patient and document as such during initial triage call.
      • Suggested documentation
        • “Explained to patient that if we are unable to contact them after multiple attempts to both them and their emergency contact, we may initiate a welfare check with the local authorities. Instructed the patient to keep their phone on them at all times.”
      • HTT or ILI Telemedicine provider will explain this policy to the patients and document as such.

8. Standardized EPIC documentation:

  • .COVIDWELFARE
    • [Smart list number] unsuccessful attempts were made to contact the patient over [smart list number] day(s).  An attempt [was/was not] made to contact the patient’s emergency contact and the emergency contact was not successful in connecting with the patient.  A welfare check from [xxx] was initiated because of the serious and imminent threat to the patient’s safety secondary to them being COVID-positive and at risk for rapid respiratory decline and/or incapacitation in the context of an inability to contact the patient or their emergency contact to verify their well-being.

Download: Patient education materials

What to do if you're exposed to someone with confirmed COVID-19
Updated on 12/08/2020 at 3:31 pm
What to do if you have confirmed or suspected COVID-19
Updated on 12/08/2020 at 3:22 pm
Family symptoms kit
Updated on 04/16/2020 at 4:00 pm

 

Measuring your symptoms patient kit
Updated on 06/09/2020 at 1:25 pm
Disinfect Breastmilk Containers for Moms with COVID-19
Updated on 04/23/2020 at 9:10 am

Safely Disinfect Breastmilk Containers at Home and Bring to the Hospital
Updated on 04/23/2020 at 9:12 am

COVID-19 - Neonatal Information Sheet
Updated on 07/23/2020 at 7:58 am

Newborn Going Home with COVID-19 or with a Mom who has COVID-19

  • Babies infectedor whose status is not known due to lack of testing, but with no symptoms of COVID-19, may be go home on a case-by-case basis. Your babies care team will teach you precautions to take. Follow-up contacts (either by phone, telemedicine, or in-office) will be scheduled through 14 days after birth.

Be sure to teach all people who will care for your baby about wearing a mask and gloves, and washing their hands.

People over the age of 60 and those with health conditions should not care for your baby if possible.

  • Babies with a negative COVID-19 test or who have never been exposed can go home when ready. A healthy (non-infected) person should care for baby.

If an exposed or positive mom is in the same house, she should try to stay at least 6 feet away from baby. When mom must be near baby, she needs to wash her hands with soap and water for at least 20 seconds. If possible, she should also put on a face mask before caring for baby.

She should do this until:

  • At least 10 days have passed since symptoms first started and
  • She does not have a temperature of greater than or equal to 38.0° C (100.4° F) for at least 24 hours without the use of medicine that lowers fevers
  • Other people who are being tested or have symptoms, should wash their hands with soap and water for at least 20 seconds and should also wear a mask if they can whenever they are within 6 feet of the baby.

Breastfeeding

Studies have not found the virus in breastmilk.

We strongly suggest mom pump breastmilk. First, they should wash their hands and breast. Then a healthy person can feed baby the milk.

Moms who want to breastfeed should wash their hands and breasts well and wear a mask. An infected mom could give baby the virus by contact when they are close during nursing but not through the breast milk.

When you get home:

  • Do not take your baby outside, except for health care
  • Do not take your baby to businesses, places of worship, or other public places
  • Do not use public transportation, ride sharing, or taxis

People: Keep baby in one room and away from other people in your home.  Do not have visitors.

Animals: Keep your baby away from pets while they are sick. Have someone else in your home care for your animals.

Cover your coughs and sneezes

Cover your mouth and nose with a tissue when coughing or sneezing. Throw used tissues in a lined trash can. Clean your hands right away.

If you do not have a tissue, hold your arm in front of your face. Cough or sneeze into your elbow. Coughing into your elbow instead of your hand is safer. When you cough into your hand, the virus gets on your hand and is easier to spread.

Clean your hands often

  • Wash with soap and water for at least 20 seconds.
  • If you do not have soap and water, clean your hands with an alcohol-based hand sanitizer with at least 60% alcohol. Cover all parts of your or older sibling’s hands and rub them together until they feel dry.
  • Soap and water are best if hands are visibly dirty.
  • Do not to touch eyes, nose, or mouth with unwashed hands.

Do not share items in the home

Do not share dishes, drinking glasses, cups, eating utensils, towels, or bedding with other people or pets in your home. After using these items, they should be washed well with soap and water.

Clean all “high-touch” surfaces each day

High-touch surfaces are counters, tabletops, doorknobs, bathroom fixtures, toilets, phones, keyboards, tablets, and bedside tables. Clean any surfaces that may have blood, stool, or body fluids on them. Use a household cleaning spray or wipe. Follow the label instructions for safe use.

Watch for symptoms

Get health care right away if your baby:

  • Has trouble breathing
  • Will not drink or breast feed
  • Does not have wet diapers often
  • Does not wake up
  • Has a fever

Call your baby’s doctor’s office and tell them your baby has been exposed to COVID-19 but can still be ill from other reasons. Keep a light sheet over your baby before going into the building and you should wear a mask. This will help the doctor’s office to keep other people in the office or waiting room from getting sick.

Discharge information for new parent recovering from COVID-19
Updated on 05/06/2020 at 12:47 pm

COVID-19 and Keeping Your Baby Safe After Delivery
Updated on 08/13/2020 at 7:39 am

Cloth Face Covering Instructions
Updated on 04/27/2020 at 4:00 pm

Home exercise program for patients with COVID-19
Updated on 05/15/2020 at 3:17 pm
Pre-Procedural Screening for COVID-19
Updated on 02/12/2021 at 12:09 pm

Inpatient Exposure Discharge Instructions
Updated on 06/11/2020 at 7:48 am

Inpatient screening for COVID-19
Updated on 07/07/2020 at 7:30 am

Handout: Guidelines for visitors of adult inpatients with COVID-19 or PUIs
Updated on 11/24/2020 at 10:44 am

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View this policy on:

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PolicyTech

How to reduce risk levels during COVID-19
Updated on 07/10/2020 at 12:52 pm

What to do if someone in your home has COVID-19
Updated on 12/09/2020 at 8:48 am

How mRNA and viral vector vaccines work
Updated on 04/05/2021 at 9:30 am