Clinical

As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.

These stories have been modified to protect patient confidentiality.

recep-bg/E+/Getty Images

Case 1

A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.

When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.

Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.

• If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
• Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.

Case 2

A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.

Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.

• Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
• Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
• Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
• In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.

Case 3

A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.

Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.

• Cleaning products can cause chemical burns. These products should not be used by young children.

Case 4

A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.

Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.

Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.

• Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
• Make sure families know the Poison Control phone number (800-222-1222).
   

   

Case 5

An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.

Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.

• Discuss with families about having easily accessible lists of medications and medical conditions.
• Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.

Case 6

A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.

Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.¹ Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.²

• Allow families to know that they are not alone and that child care is difficult
• Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
• Provide strategies on your practice’s website if a situation at home becomes tense and strained.

Case 7

An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.

Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.³

• Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
• Social isolation may contribute to worsening mental health
• Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.

Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?

Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at pdnews@mdedge.com.

References

1. Child Dev. 1978;49:604-16.

2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.

3. BMJ 2013;347:f5239.

As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.

These stories have been modified to protect patient confidentiality.

recep-bg/E+/Getty Images

Case 1

A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.

When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.

Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.

• If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
• Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.

Case 2

A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.

Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.

• Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
• Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
• Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
• In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.

Case 3

A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.

Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.

• Cleaning products can cause chemical burns. These products should not be used by young children.

Case 4

A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.

Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.

Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.

• Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
• Make sure families know the Poison Control phone number (800-222-1222).
   

   

Case 5

An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.

Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.

• Discuss with families about having easily accessible lists of medications and medical conditions.
• Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.

Case 6

A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.

Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.¹ Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.²

• Allow families to know that they are not alone and that child care is difficult
• Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
• Provide strategies on your practice’s website if a situation at home becomes tense and strained.

Case 7

An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.

Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.³

• Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
• Social isolation may contribute to worsening mental health
• Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.

Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?

Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at pdnews@mdedge.com.

References

1. Child Dev. 1978;49:604-16.

2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.

3. BMJ 2013;347:f5239.

As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.

These stories have been modified to protect patient confidentiality.

recep-bg/E+/Getty Images

Case 1

A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.

When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.

Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.

• If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
• Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.

Case 2

A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.

Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.

• Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
• Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
• Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
• In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.

Case 3

A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.

Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.

• Cleaning products can cause chemical burns. These products should not be used by young children.

Case 4

A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.

Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.

Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.

• Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
• Make sure families know the Poison Control phone number (800-222-1222).
   

   

Case 5

An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.

Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.

• Discuss with families about having easily accessible lists of medications and medical conditions.
• Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.

Case 6

A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.

Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.¹ Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.²

• Allow families to know that they are not alone and that child care is difficult
• Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
• Provide strategies on your practice’s website if a situation at home becomes tense and strained.

Case 7

An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.

Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.³

• Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
• Social isolation may contribute to worsening mental health
• Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.

Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?

Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at pdnews@mdedge.com.

References

1. Child Dev. 1978;49:604-16.

2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.

3. BMJ 2013;347:f5239.

The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.

“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.

On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.

In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.

“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.

The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.

The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.

Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.

mlesney@mdedge.com

The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.

“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.

On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.

In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.

“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.

The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.

The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.

Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.

mlesney@mdedge.com

The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.

“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.

On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.

In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.

“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.

The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.

The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.

Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.

mlesney@mdedge.com

COVID-19 has been a watershed event in medical history of epic proportions. With this fast-spreading pandemic stretching resources at health care institutions, practical considerations for management of a disease about which we are still learning has been a huge challenge.

Although many guidelines have been made available by medical societies and experts worldwide, there appear to be very few which throw light on management in a resource-poor setup. The hospitalist, as a front-line provider, is likely expected to lead the planning and management of resources in order to deliver appropriate care.

As per American Hospital Association data, there are 2,704 community hospitals that can deliver ICU care in the United States. There are 534,964 acute care beds with 96,596 ICU beds. Additionally, there are 25,157 step-down beds and 1,183 burn unit beds. Of the 2,704 hospitals, 74% are in metropolitan areas (> 50,000 population), 17% (464) are in micropolitan areas (10,000-49,999 population), and the remaining 9% (244) are in rural areas. Only 7% (36,453) of hospital beds and 5% (4715) of ICU beds are in micropolitan areas. Two percent of acute care hospital beds and 1% of ICU beds are in rural areas. Although the US has the highest per capita number of ICU beds in the world, this may not be sufficient as these are concentrated in highly populated metropolitan areas.

Infrastructure and human power resource augmentation will be important. Infrastructure can be ramped up by:

• Canceling elective procedures
• Using the operating room and perioperative room ventilators and beds
• Servicing and using older functioning hospitals, medical wards, and ventilators.

As ventilators are expected to be in short supply, while far from ideal, other resources may include using ventilators from the Strategic National Stockpile, renting from vendors, and using state-owned stockpiles. Use of non-invasive ventilators, such as CPAP (continuous positive airway pressure), BiPAP (bi-level positive airway pressure), and HFNC (high-flow nasal cannula) may be considered in addition to full-featured ventilators. Rapidly manufacturing new ventilators with government direction is also being undertaken.

Lack of PPE and fear among health care staff

There have been widespread reports in the media, and several anecdotal reports, about severe shortages of personal protective equipment (PPE), and as a result, an increase in fear and anxiety among frontline health care workers.

In addition, there also have been reports about hospital administrators disciplining medical and nursing staff for voicing their concerns about PPE shortages to the general public and the media. This likely stems from the narrow “optics” and public relations concerns of health care facilities.

It is evident that the size and magnitude of the COVID-19 pandemic was grossly underestimated, and preparations were inadequate. But according to past surveys of health care workers, a good number of them believe that medical and nursing staff have a duty to deliver care to sick people even if it exposes them to personal danger.

Given the special skills and privileges that health care professionals possess, they do have a moral and ethical responsibility to take care of sick patients even if a danger to themselves exists. However, society also has a responsibility to provide for the safety of these health care workers by supplying them with appropriate safety gear. Given the unprecedented nature of this pandemic, it is obvious that federal and state governments, public health officials, and hospital administrators (along with health care professionals) are still learning how to appropriately respond to the challenge.

It would be reasonable and appropriate for everyone concerned to understand and acknowledge that there is a shortage of PPE, and while arranging for this to be replenished, undertake and implement measures that maximize the safety of all health care workers. An open forum, mutually agreed-upon policy and procedures, along with mechanisms to address concerns should be formulated.

In addition, health care workers who test positive for COVID-19 can be a source of infection for other health care workers and non-infected patients. Therefore, health care workers have the responsibility of reporting their symptoms, the right to have themselves tested, and they must follow agreed-upon procedures that would limit their ability to infect other people, including mandated absenteeism from work. Every individual has a right to safety at the workplace and this right cannot be compromised, as otherwise this will lead to a suboptimal response to the pandemic. The government, hospital administrators, and health care workers will need to come together and work cohesively.
 

Ethical issues surrounding resource allocation

At the time of hospital admission, any suspected or confirmed COVID-19 patient should have his or her wishes recorded with the admitting team regarding the goals of care and code status. During any critical illness, goals evolve depending on discussions, reflections of the patient with family, and clinical response to therapy. A patient who does not want any kind of life support obviously should not be offered an ICU level of care.

On the other hand, in the event of resources becoming overwhelmed by demand as can be expected during this pandemic, careful ethical considerations will need to be applied.

A carefully crafted transparent ethical framework, with a clear understanding of the decision-making process, that involves all stakeholders – including government entities, public health officials, health care workers, ethics specialists, and members of the community – is essential. Ideally, allocation of resources should be made according to a well-written plan, by a triage team that can include a nontreating physician, bioethicists, legal personnel, and religious representatives. It should not be left to the front-line treating physician, who is unlikely to be trained to make these decisions and who has an ethical responsibility to advocate for the patient under his care.
 

Ethical principles that deserve consideration

The “principle of utility” provides the maximum possible benefit to the maximum number of people. It should not only save the greatest number of lives but also maximize improvements in individuals’ posttreatment length of life.

The “principle of equity” requires that resources are allocated on a nondiscriminatory basis with a fair distribution of benefits and burdens. When conflicts arise between these two principles, a balanced approach likely will help when handled with a transparent decision-making process, with decisions to be applied consistently. Most experts would agree on not only saving more lives but also in preserving more years of life.

The distribution of medical resources should not be based on age or disability. Frailty and functional status are important considerations; however, priority is to be given to sicker patients who have lesser comorbidities and are also likely to survive longer. This could entail that younger, healthier patients will access scarce resources based on the principle of maximizing benefits.

Another consideration is “preservation of functioning of the society.” Those individuals who are important for providing important public services, health care services, and the functioning of other key aspects of society can be considered for prioritization of resources. While this may not satisfy the classic utilitarian principle of doing maximum good to the maximum number of people, it will help to continue augmenting the fight against the pandemic because of the critical role that such individuals play.

For patients with a similar prognosis, the principle of equality comes into play, and distribution should be done by way of random allocation, like a lottery. Distribution based on the principle of “first come, first served” is unlikely to be a fair process, as it would likely discriminate against patients based on their ability to access care.

Care should also be taken not to discriminate among people who have COVID-19 and non–COVID-19 health conditions that require medical care. Distribution should never be done based on an individual’s political influence, celebrity, or financial status, as occurred in the early days of the pandemic regarding access to testing.
 

Resuscitation or not?

Should a COVID-19 positive patient be offered CPR in case of cardiac arrest? The concern is that CPR is a high-level aerosolizing procedure and PPE is in short supply with the worsening of the pandemic. This will depend more on local policies and resource availability, along with goals of care that have to be determined at the time of admission and subsequent conversations.

The American Hospital Association has issued a general guideline and as more data become available, we can have more informed discussions with patients and families. At this point, all due precautions that prevent the infection of health care personnel are applicable.

Ethical considerations often do not have answers that are a universal fit, and the challenge is always to promote the best interest of the patient with a balance of judiciously utilizing scarce community resources.

Although many states have had discussions and some even have written policies, they have never been implemented. The organization and application of a judicious ethical “crisis level of care” is extremely challenging and likely to test the foundation and fabric of the society.
 

Dr. Jain is senior associate consultant, hospital & critical care medicine, at Mayo Clinic in Mankato, Minn. He is a board-certified internal medicine, pulmonary, and critical care physician, and has special interests in rural medicine and ethical issues involving critical care medicine. Dr. Tirupathi is the medical director of keystone infectious diseases/HIV in Chambersburg and is currently chair of infection prevention at Wellspan Chambersburg and Waynesboro Hospitals, all in Pennsylvania. Dr. Palabindala is hospital medicine division chief at the University of Mississippi Medical Center, Jackson, and a member of the editorial advisory board for The Hospitalist.

Sources

1. United States Resource Availability for COVID-19. SCCM Blog.

2. Intensive care medicine: Triage in case of bottlenecks. l

3. Interim Guidance for Healthcare Providers during COVID-19 Outbreak.

4. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med 2020 Mar 23.doi: 10.1056/NEJMsb2005114.

5. Devnani M et al. Planning and response to the influenza A (H1N1) pandemic: Ethics, equity and justice. Indian J Med Ethics. 2011 Oct-Dec;8(4):237-40.

6. Alexander C and Wynia M. Ready and willing? Physicians’ sense of preparedness for bioterrorism. Health Aff (Millwood). 2003 Sep-Oct;22(5):189-97.

7. Damery S et al. Healthcare workers’ perceptions of the duty to work during an influenza pandemic. J Med Ethics. 2010 Jan;36(1):12-8.
 

COVID-19 has been a watershed event in medical history of epic proportions. With this fast-spreading pandemic stretching resources at health care institutions, practical considerations for management of a disease about which we are still learning has been a huge challenge.

Although many guidelines have been made available by medical societies and experts worldwide, there appear to be very few which throw light on management in a resource-poor setup. The hospitalist, as a front-line provider, is likely expected to lead the planning and management of resources in order to deliver appropriate care.

As per American Hospital Association data, there are 2,704 community hospitals that can deliver ICU care in the United States. There are 534,964 acute care beds with 96,596 ICU beds. Additionally, there are 25,157 step-down beds and 1,183 burn unit beds. Of the 2,704 hospitals, 74% are in metropolitan areas (> 50,000 population), 17% (464) are in micropolitan areas (10,000-49,999 population), and the remaining 9% (244) are in rural areas. Only 7% (36,453) of hospital beds and 5% (4715) of ICU beds are in micropolitan areas. Two percent of acute care hospital beds and 1% of ICU beds are in rural areas. Although the US has the highest per capita number of ICU beds in the world, this may not be sufficient as these are concentrated in highly populated metropolitan areas.

Infrastructure and human power resource augmentation will be important. Infrastructure can be ramped up by:

• Canceling elective procedures
• Using the operating room and perioperative room ventilators and beds
• Servicing and using older functioning hospitals, medical wards, and ventilators.

As ventilators are expected to be in short supply, while far from ideal, other resources may include using ventilators from the Strategic National Stockpile, renting from vendors, and using state-owned stockpiles. Use of non-invasive ventilators, such as CPAP (continuous positive airway pressure), BiPAP (bi-level positive airway pressure), and HFNC (high-flow nasal cannula) may be considered in addition to full-featured ventilators. Rapidly manufacturing new ventilators with government direction is also being undertaken.

Lack of PPE and fear among health care staff

There have been widespread reports in the media, and several anecdotal reports, about severe shortages of personal protective equipment (PPE), and as a result, an increase in fear and anxiety among frontline health care workers.

In addition, there also have been reports about hospital administrators disciplining medical and nursing staff for voicing their concerns about PPE shortages to the general public and the media. This likely stems from the narrow “optics” and public relations concerns of health care facilities.

It is evident that the size and magnitude of the COVID-19 pandemic was grossly underestimated, and preparations were inadequate. But according to past surveys of health care workers, a good number of them believe that medical and nursing staff have a duty to deliver care to sick people even if it exposes them to personal danger.

Given the special skills and privileges that health care professionals possess, they do have a moral and ethical responsibility to take care of sick patients even if a danger to themselves exists. However, society also has a responsibility to provide for the safety of these health care workers by supplying them with appropriate safety gear. Given the unprecedented nature of this pandemic, it is obvious that federal and state governments, public health officials, and hospital administrators (along with health care professionals) are still learning how to appropriately respond to the challenge.

It would be reasonable and appropriate for everyone concerned to understand and acknowledge that there is a shortage of PPE, and while arranging for this to be replenished, undertake and implement measures that maximize the safety of all health care workers. An open forum, mutually agreed-upon policy and procedures, along with mechanisms to address concerns should be formulated.

In addition, health care workers who test positive for COVID-19 can be a source of infection for other health care workers and non-infected patients. Therefore, health care workers have the responsibility of reporting their symptoms, the right to have themselves tested, and they must follow agreed-upon procedures that would limit their ability to infect other people, including mandated absenteeism from work. Every individual has a right to safety at the workplace and this right cannot be compromised, as otherwise this will lead to a suboptimal response to the pandemic. The government, hospital administrators, and health care workers will need to come together and work cohesively.
 

Ethical issues surrounding resource allocation

At the time of hospital admission, any suspected or confirmed COVID-19 patient should have his or her wishes recorded with the admitting team regarding the goals of care and code status. During any critical illness, goals evolve depending on discussions, reflections of the patient with family, and clinical response to therapy. A patient who does not want any kind of life support obviously should not be offered an ICU level of care.

On the other hand, in the event of resources becoming overwhelmed by demand as can be expected during this pandemic, careful ethical considerations will need to be applied.

A carefully crafted transparent ethical framework, with a clear understanding of the decision-making process, that involves all stakeholders – including government entities, public health officials, health care workers, ethics specialists, and members of the community – is essential. Ideally, allocation of resources should be made according to a well-written plan, by a triage team that can include a nontreating physician, bioethicists, legal personnel, and religious representatives. It should not be left to the front-line treating physician, who is unlikely to be trained to make these decisions and who has an ethical responsibility to advocate for the patient under his care.
 

Ethical principles that deserve consideration

The “principle of utility” provides the maximum possible benefit to the maximum number of people. It should not only save the greatest number of lives but also maximize improvements in individuals’ posttreatment length of life.

The “principle of equity” requires that resources are allocated on a nondiscriminatory basis with a fair distribution of benefits and burdens. When conflicts arise between these two principles, a balanced approach likely will help when handled with a transparent decision-making process, with decisions to be applied consistently. Most experts would agree on not only saving more lives but also in preserving more years of life.

The distribution of medical resources should not be based on age or disability. Frailty and functional status are important considerations; however, priority is to be given to sicker patients who have lesser comorbidities and are also likely to survive longer. This could entail that younger, healthier patients will access scarce resources based on the principle of maximizing benefits.

Another consideration is “preservation of functioning of the society.” Those individuals who are important for providing important public services, health care services, and the functioning of other key aspects of society can be considered for prioritization of resources. While this may not satisfy the classic utilitarian principle of doing maximum good to the maximum number of people, it will help to continue augmenting the fight against the pandemic because of the critical role that such individuals play.

For patients with a similar prognosis, the principle of equality comes into play, and distribution should be done by way of random allocation, like a lottery. Distribution based on the principle of “first come, first served” is unlikely to be a fair process, as it would likely discriminate against patients based on their ability to access care.

Care should also be taken not to discriminate among people who have COVID-19 and non–COVID-19 health conditions that require medical care. Distribution should never be done based on an individual’s political influence, celebrity, or financial status, as occurred in the early days of the pandemic regarding access to testing.
 

Resuscitation or not?

Should a COVID-19 positive patient be offered CPR in case of cardiac arrest? The concern is that CPR is a high-level aerosolizing procedure and PPE is in short supply with the worsening of the pandemic. This will depend more on local policies and resource availability, along with goals of care that have to be determined at the time of admission and subsequent conversations.

The American Hospital Association has issued a general guideline and as more data become available, we can have more informed discussions with patients and families. At this point, all due precautions that prevent the infection of health care personnel are applicable.

Ethical considerations often do not have answers that are a universal fit, and the challenge is always to promote the best interest of the patient with a balance of judiciously utilizing scarce community resources.

Although many states have had discussions and some even have written policies, they have never been implemented. The organization and application of a judicious ethical “crisis level of care” is extremely challenging and likely to test the foundation and fabric of the society.
 

Dr. Jain is senior associate consultant, hospital & critical care medicine, at Mayo Clinic in Mankato, Minn. He is a board-certified internal medicine, pulmonary, and critical care physician, and has special interests in rural medicine and ethical issues involving critical care medicine. Dr. Tirupathi is the medical director of keystone infectious diseases/HIV in Chambersburg and is currently chair of infection prevention at Wellspan Chambersburg and Waynesboro Hospitals, all in Pennsylvania. Dr. Palabindala is hospital medicine division chief at the University of Mississippi Medical Center, Jackson, and a member of the editorial advisory board for The Hospitalist.

Sources

1. United States Resource Availability for COVID-19. SCCM Blog.

2. Intensive care medicine: Triage in case of bottlenecks. l

3. Interim Guidance for Healthcare Providers during COVID-19 Outbreak.

4. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med 2020 Mar 23.doi: 10.1056/NEJMsb2005114.

5. Devnani M et al. Planning and response to the influenza A (H1N1) pandemic: Ethics, equity and justice. Indian J Med Ethics. 2011 Oct-Dec;8(4):237-40.

6. Alexander C and Wynia M. Ready and willing? Physicians’ sense of preparedness for bioterrorism. Health Aff (Millwood). 2003 Sep-Oct;22(5):189-97.

7. Damery S et al. Healthcare workers’ perceptions of the duty to work during an influenza pandemic. J Med Ethics. 2010 Jan;36(1):12-8.
 

COVID-19 has been a watershed event in medical history of epic proportions. With this fast-spreading pandemic stretching resources at health care institutions, practical considerations for management of a disease about which we are still learning has been a huge challenge.

Although many guidelines have been made available by medical societies and experts worldwide, there appear to be very few which throw light on management in a resource-poor setup. The hospitalist, as a front-line provider, is likely expected to lead the planning and management of resources in order to deliver appropriate care.

As per American Hospital Association data, there are 2,704 community hospitals that can deliver ICU care in the United States. There are 534,964 acute care beds with 96,596 ICU beds. Additionally, there are 25,157 step-down beds and 1,183 burn unit beds. Of the 2,704 hospitals, 74% are in metropolitan areas (> 50,000 population), 17% (464) are in micropolitan areas (10,000-49,999 population), and the remaining 9% (244) are in rural areas. Only 7% (36,453) of hospital beds and 5% (4715) of ICU beds are in micropolitan areas. Two percent of acute care hospital beds and 1% of ICU beds are in rural areas. Although the US has the highest per capita number of ICU beds in the world, this may not be sufficient as these are concentrated in highly populated metropolitan areas.

Infrastructure and human power resource augmentation will be important. Infrastructure can be ramped up by:

• Canceling elective procedures
• Using the operating room and perioperative room ventilators and beds
• Servicing and using older functioning hospitals, medical wards, and ventilators.

As ventilators are expected to be in short supply, while far from ideal, other resources may include using ventilators from the Strategic National Stockpile, renting from vendors, and using state-owned stockpiles. Use of non-invasive ventilators, such as CPAP (continuous positive airway pressure), BiPAP (bi-level positive airway pressure), and HFNC (high-flow nasal cannula) may be considered in addition to full-featured ventilators. Rapidly manufacturing new ventilators with government direction is also being undertaken.

Lack of PPE and fear among health care staff

There have been widespread reports in the media, and several anecdotal reports, about severe shortages of personal protective equipment (PPE), and as a result, an increase in fear and anxiety among frontline health care workers.

In addition, there also have been reports about hospital administrators disciplining medical and nursing staff for voicing their concerns about PPE shortages to the general public and the media. This likely stems from the narrow “optics” and public relations concerns of health care facilities.

It is evident that the size and magnitude of the COVID-19 pandemic was grossly underestimated, and preparations were inadequate. But according to past surveys of health care workers, a good number of them believe that medical and nursing staff have a duty to deliver care to sick people even if it exposes them to personal danger.

Given the special skills and privileges that health care professionals possess, they do have a moral and ethical responsibility to take care of sick patients even if a danger to themselves exists. However, society also has a responsibility to provide for the safety of these health care workers by supplying them with appropriate safety gear. Given the unprecedented nature of this pandemic, it is obvious that federal and state governments, public health officials, and hospital administrators (along with health care professionals) are still learning how to appropriately respond to the challenge.

It would be reasonable and appropriate for everyone concerned to understand and acknowledge that there is a shortage of PPE, and while arranging for this to be replenished, undertake and implement measures that maximize the safety of all health care workers. An open forum, mutually agreed-upon policy and procedures, along with mechanisms to address concerns should be formulated.

In addition, health care workers who test positive for COVID-19 can be a source of infection for other health care workers and non-infected patients. Therefore, health care workers have the responsibility of reporting their symptoms, the right to have themselves tested, and they must follow agreed-upon procedures that would limit their ability to infect other people, including mandated absenteeism from work. Every individual has a right to safety at the workplace and this right cannot be compromised, as otherwise this will lead to a suboptimal response to the pandemic. The government, hospital administrators, and health care workers will need to come together and work cohesively.
 

Ethical issues surrounding resource allocation

At the time of hospital admission, any suspected or confirmed COVID-19 patient should have his or her wishes recorded with the admitting team regarding the goals of care and code status. During any critical illness, goals evolve depending on discussions, reflections of the patient with family, and clinical response to therapy. A patient who does not want any kind of life support obviously should not be offered an ICU level of care.

On the other hand, in the event of resources becoming overwhelmed by demand as can be expected during this pandemic, careful ethical considerations will need to be applied.

A carefully crafted transparent ethical framework, with a clear understanding of the decision-making process, that involves all stakeholders – including government entities, public health officials, health care workers, ethics specialists, and members of the community – is essential. Ideally, allocation of resources should be made according to a well-written plan, by a triage team that can include a nontreating physician, bioethicists, legal personnel, and religious representatives. It should not be left to the front-line treating physician, who is unlikely to be trained to make these decisions and who has an ethical responsibility to advocate for the patient under his care.
 

Ethical principles that deserve consideration

The “principle of utility” provides the maximum possible benefit to the maximum number of people. It should not only save the greatest number of lives but also maximize improvements in individuals’ posttreatment length of life.

The “principle of equity” requires that resources are allocated on a nondiscriminatory basis with a fair distribution of benefits and burdens. When conflicts arise between these two principles, a balanced approach likely will help when handled with a transparent decision-making process, with decisions to be applied consistently. Most experts would agree on not only saving more lives but also in preserving more years of life.

The distribution of medical resources should not be based on age or disability. Frailty and functional status are important considerations; however, priority is to be given to sicker patients who have lesser comorbidities and are also likely to survive longer. This could entail that younger, healthier patients will access scarce resources based on the principle of maximizing benefits.

Another consideration is “preservation of functioning of the society.” Those individuals who are important for providing important public services, health care services, and the functioning of other key aspects of society can be considered for prioritization of resources. While this may not satisfy the classic utilitarian principle of doing maximum good to the maximum number of people, it will help to continue augmenting the fight against the pandemic because of the critical role that such individuals play.

For patients with a similar prognosis, the principle of equality comes into play, and distribution should be done by way of random allocation, like a lottery. Distribution based on the principle of “first come, first served” is unlikely to be a fair process, as it would likely discriminate against patients based on their ability to access care.

Care should also be taken not to discriminate among people who have COVID-19 and non–COVID-19 health conditions that require medical care. Distribution should never be done based on an individual’s political influence, celebrity, or financial status, as occurred in the early days of the pandemic regarding access to testing.
 

Resuscitation or not?

Should a COVID-19 positive patient be offered CPR in case of cardiac arrest? The concern is that CPR is a high-level aerosolizing procedure and PPE is in short supply with the worsening of the pandemic. This will depend more on local policies and resource availability, along with goals of care that have to be determined at the time of admission and subsequent conversations.

The American Hospital Association has issued a general guideline and as more data become available, we can have more informed discussions with patients and families. At this point, all due precautions that prevent the infection of health care personnel are applicable.

Ethical considerations often do not have answers that are a universal fit, and the challenge is always to promote the best interest of the patient with a balance of judiciously utilizing scarce community resources.

Although many states have had discussions and some even have written policies, they have never been implemented. The organization and application of a judicious ethical “crisis level of care” is extremely challenging and likely to test the foundation and fabric of the society.
 

Dr. Jain is senior associate consultant, hospital & critical care medicine, at Mayo Clinic in Mankato, Minn. He is a board-certified internal medicine, pulmonary, and critical care physician, and has special interests in rural medicine and ethical issues involving critical care medicine. Dr. Tirupathi is the medical director of keystone infectious diseases/HIV in Chambersburg and is currently chair of infection prevention at Wellspan Chambersburg and Waynesboro Hospitals, all in Pennsylvania. Dr. Palabindala is hospital medicine division chief at the University of Mississippi Medical Center, Jackson, and a member of the editorial advisory board for The Hospitalist.

Sources

1. United States Resource Availability for COVID-19. SCCM Blog.

2. Intensive care medicine: Triage in case of bottlenecks. l

3. Interim Guidance for Healthcare Providers during COVID-19 Outbreak.

4. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med 2020 Mar 23.doi: 10.1056/NEJMsb2005114.

5. Devnani M et al. Planning and response to the influenza A (H1N1) pandemic: Ethics, equity and justice. Indian J Med Ethics. 2011 Oct-Dec;8(4):237-40.

6. Alexander C and Wynia M. Ready and willing? Physicians’ sense of preparedness for bioterrorism. Health Aff (Millwood). 2003 Sep-Oct;22(5):189-97.

7. Damery S et al. Healthcare workers’ perceptions of the duty to work during an influenza pandemic. J Med Ethics. 2010 Jan;36(1):12-8.
 

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

A physician couple who both had COVID-19 had very different responses — one ending up in intensive care, the other asymptomatic.

Their story, one of two people living together but with such different responses to the infection, illustrates how much is still to be learned about COVID-19, says Noopur Raje, MD, professor of medicine at Harvard Medical School and director of the Center for Multiple Myeloma at Massachusetts General Hospital (MGH) in Boston.

“After experiencing #Covid_19 from the patient/caregiver end despite both of us being physicians at a major academic medical center, this has been a challenge like no other I have experienced,” Raje (@NoopurRajeMD) wrote on Twitter.

She outlined their experiences in a Twitter thread and elaborated in an interview with Medscape Medical News.

Raje says that she wants clinicians to know how symptoms can evolve both quickly and suddenly.

She recalls how for 10 days, she cared for her COVID-19–positive husband at home, separated from him by a floor in their Boston townhouse and wearing a surgical mask and gloves to bring him food and fluids, as he was too weak to help himself.

Despite the high fevers, chills, extreme fatigue, and dramatic weight loss, Raje says she felt reasonably confident that her husband was getting better. His temperature had dropped from around 103 to 101, his heart rate was in the 80s, and his blood pressure was “OK,” she recalls.

But then Jag Singh, MD, an otherwise healthy 55-year-old Harvard professor and cardiologist, started to cough — and everything suddenly changed.

The cough sounded chesty, and he was weak and unwell. They decided that he needed medical help.

“I was planning on driving him to the hospital, but I ended up having to call 911, although we literally live across the street,” she said.

“We have stairs here and I wasn’t sure that he would be able to make it coming down with me trying to help him, so the safest thing was for me to call for help.”

Singh was admitted straight to the medical intensive care unit (MICU) while his wife waited at home.

“I was blown away when I saw Jag’s x-ray and CT scan and the bilateral pneumonia he had developed,” she commented. “I would not have believed it, the way he was clinically — and seeing that x-ray.

“Honestly, when I took him in to hospital, I thought he’d be there a couple of days — over the weekend — and I’d get him back Monday. But it didn’t turn out that way. He was there for about 9 days.”

That first night in the hospital, Singh consented to intubation — should he need it. “He called me then,” said Raje. “I said we’ve got to do what we’ve got to do, it’s OK — it is what it is, and we’ll do whatever it takes.”

He remained in the MICU overnight and through the next day, still breathing on his own, but with the looming prospect of mechanical ventilation.

“The good news is he maintained his oxygen saturations throughout,” said Raje. “I was able to see his vitals with EPIC [remote monitoring] ... It was crazy,” she recalls. “Seeing a respiratory rate of 26 was difficult. When you see that, you worry about somebody tiring with the breathing. His inflammatory markers kept climbing, his fevers persisted.”

Thankfully, he never needed the ventilator.

But by this time Raje had another worry: She, too, had tested positive and was now alone at home.

“I was unable to talk to my extended family as they all looked to us as physicians for support,” she tweeted. Both children came to Boston to see her, but she saw them only through a window.

Alone, she waited for the same symptoms that had slammed her husband; but they never came — something she wants caregivers to know.

“The fear and anxiety of taking care of somebody who’s COVID positive ... I am hoping that can be alleviated a little bit at least,” she said. “If you’ve been taking care of someone, chances are you’re probably positive already and if you’re not sick, the chances of you getting sick are really low, so don’t be afraid to take care of that person.”

Singh is recovering well at home now, almost a month into his illness. During the interview, conducted via Zoom, he could be heard coughing in the background.

While in the MICU, Singh was treated with azithromycin and hydroxychloroquine — standard at MGH for critically ill COVID-19 patients — and he was also enrolled into a double-blind, randomized, placebo-controlled trial of the investigational agent remdesivir (Gilead).

Raje is not sure what, if anything, helped him turn the corner.

“I saw his inflammatory markers get worse actually — I don’t think we can know if the drugs made a difference,” she says. “His first dose of hydroxychloroquine was Friday night when he was admitted, and the markers continued to climb until the next Thursday.”

In particular, his C-reactive protein (CRP) kept rising, reaching the 260 to 270 mg/dL range, “which to me was scary,” she said. “I do think he had a cytokine storm going, but I didn’t see those results.”

“Understanding the immune compartment is going to be so, so critically important and what it is that we can do to boost folks’ immune systems,” she said.

“If you have a very high viral load and your immune system is not 100% even though you’re otherwise healthy, you might be the person who ends up with that more serious response to this virus. Trying to study this in a focused way, looking at the immune compartment, looking at the antibody status, looking at the viral load — there’s so much more we need to look at. Until we get the vaccine, which is probably a year-and-a-half away, we need to look at how can we develop that herd immunity so we don’t have folks getting as critically ill as they do.”

Despite feeling perfectly healthy, Raje is still at home. Three weeks after her first test, she is still testing positive for COVID-19, waiting for two consecutive negative results 72 hours apart before she is allowed back to work at the hospital.

When she gets the green light, she plans to go work on the COVID-19 floor, if needed. “It’s people like us [who have had COVID-19] who have to get back in the trenches and do the work now,” she says.

“My biggest concern is that it’s a very isolating experience for the COVID-positive patient. We are doing complete-barrier nursing — they are completely alone. The only person who ever walks into the room is the nurse — and the physician goes in once a day. It’s so important that we don’t lose sight of compassion,” she says.

“That’s why, in terms of alleviating anxiety, it is so important we do antibody testing so that people can actually go in and take care of these folks.”

‘Look for red flag’

Raje wants physicians to warn their self-isolating patients and caregivers to look for red flags. “There are primary care physicians who reached out to me [after my tweets] and said ‘when someone calls me and says it’s been 5-7 days and I am still not feeling well, I am going to look at that more seriously.’

“Part of me wanting to share this experience was basically to dispel the notion that 2 weeks into this you’re going to be fine,” she said, because it is not widely appreciated, she feels that “in week 2, you could become pretty sick.”

This article first appeared on Medscape.com.

A physician couple who both had COVID-19 had very different responses — one ending up in intensive care, the other asymptomatic.

Their story, one of two people living together but with such different responses to the infection, illustrates how much is still to be learned about COVID-19, says Noopur Raje, MD, professor of medicine at Harvard Medical School and director of the Center for Multiple Myeloma at Massachusetts General Hospital (MGH) in Boston.

“After experiencing #Covid_19 from the patient/caregiver end despite both of us being physicians at a major academic medical center, this has been a challenge like no other I have experienced,” Raje (@NoopurRajeMD) wrote on Twitter.

She outlined their experiences in a Twitter thread and elaborated in an interview with Medscape Medical News.

Raje says that she wants clinicians to know how symptoms can evolve both quickly and suddenly.

She recalls how for 10 days, she cared for her COVID-19–positive husband at home, separated from him by a floor in their Boston townhouse and wearing a surgical mask and gloves to bring him food and fluids, as he was too weak to help himself.

Despite the high fevers, chills, extreme fatigue, and dramatic weight loss, Raje says she felt reasonably confident that her husband was getting better. His temperature had dropped from around 103 to 101, his heart rate was in the 80s, and his blood pressure was “OK,” she recalls.

But then Jag Singh, MD, an otherwise healthy 55-year-old Harvard professor and cardiologist, started to cough — and everything suddenly changed.

The cough sounded chesty, and he was weak and unwell. They decided that he needed medical help.

“I was planning on driving him to the hospital, but I ended up having to call 911, although we literally live across the street,” she said.

“We have stairs here and I wasn’t sure that he would be able to make it coming down with me trying to help him, so the safest thing was for me to call for help.”

Singh was admitted straight to the medical intensive care unit (MICU) while his wife waited at home.

“I was blown away when I saw Jag’s x-ray and CT scan and the bilateral pneumonia he had developed,” she commented. “I would not have believed it, the way he was clinically — and seeing that x-ray.

“Honestly, when I took him in to hospital, I thought he’d be there a couple of days — over the weekend — and I’d get him back Monday. But it didn’t turn out that way. He was there for about 9 days.”

That first night in the hospital, Singh consented to intubation — should he need it. “He called me then,” said Raje. “I said we’ve got to do what we’ve got to do, it’s OK — it is what it is, and we’ll do whatever it takes.”

He remained in the MICU overnight and through the next day, still breathing on his own, but with the looming prospect of mechanical ventilation.

“The good news is he maintained his oxygen saturations throughout,” said Raje. “I was able to see his vitals with EPIC [remote monitoring] ... It was crazy,” she recalls. “Seeing a respiratory rate of 26 was difficult. When you see that, you worry about somebody tiring with the breathing. His inflammatory markers kept climbing, his fevers persisted.”

Thankfully, he never needed the ventilator.

But by this time Raje had another worry: She, too, had tested positive and was now alone at home.

“I was unable to talk to my extended family as they all looked to us as physicians for support,” she tweeted. Both children came to Boston to see her, but she saw them only through a window.

Alone, she waited for the same symptoms that had slammed her husband; but they never came — something she wants caregivers to know.

“The fear and anxiety of taking care of somebody who’s COVID positive ... I am hoping that can be alleviated a little bit at least,” she said. “If you’ve been taking care of someone, chances are you’re probably positive already and if you’re not sick, the chances of you getting sick are really low, so don’t be afraid to take care of that person.”

Singh is recovering well at home now, almost a month into his illness. During the interview, conducted via Zoom, he could be heard coughing in the background.

While in the MICU, Singh was treated with azithromycin and hydroxychloroquine — standard at MGH for critically ill COVID-19 patients — and he was also enrolled into a double-blind, randomized, placebo-controlled trial of the investigational agent remdesivir (Gilead).

Raje is not sure what, if anything, helped him turn the corner.

“I saw his inflammatory markers get worse actually — I don’t think we can know if the drugs made a difference,” she says. “His first dose of hydroxychloroquine was Friday night when he was admitted, and the markers continued to climb until the next Thursday.”

In particular, his C-reactive protein (CRP) kept rising, reaching the 260 to 270 mg/dL range, “which to me was scary,” she said. “I do think he had a cytokine storm going, but I didn’t see those results.”

“Understanding the immune compartment is going to be so, so critically important and what it is that we can do to boost folks’ immune systems,” she said.

“If you have a very high viral load and your immune system is not 100% even though you’re otherwise healthy, you might be the person who ends up with that more serious response to this virus. Trying to study this in a focused way, looking at the immune compartment, looking at the antibody status, looking at the viral load — there’s so much more we need to look at. Until we get the vaccine, which is probably a year-and-a-half away, we need to look at how can we develop that herd immunity so we don’t have folks getting as critically ill as they do.”

Despite feeling perfectly healthy, Raje is still at home. Three weeks after her first test, she is still testing positive for COVID-19, waiting for two consecutive negative results 72 hours apart before she is allowed back to work at the hospital.

When she gets the green light, she plans to go work on the COVID-19 floor, if needed. “It’s people like us [who have had COVID-19] who have to get back in the trenches and do the work now,” she says.

“My biggest concern is that it’s a very isolating experience for the COVID-positive patient. We are doing complete-barrier nursing — they are completely alone. The only person who ever walks into the room is the nurse — and the physician goes in once a day. It’s so important that we don’t lose sight of compassion,” she says.

“That’s why, in terms of alleviating anxiety, it is so important we do antibody testing so that people can actually go in and take care of these folks.”

‘Look for red flag’

Raje wants physicians to warn their self-isolating patients and caregivers to look for red flags. “There are primary care physicians who reached out to me [after my tweets] and said ‘when someone calls me and says it’s been 5-7 days and I am still not feeling well, I am going to look at that more seriously.’

“Part of me wanting to share this experience was basically to dispel the notion that 2 weeks into this you’re going to be fine,” she said, because it is not widely appreciated, she feels that “in week 2, you could become pretty sick.”

This article first appeared on Medscape.com.

A physician couple who both had COVID-19 had very different responses — one ending up in intensive care, the other asymptomatic.

Their story, one of two people living together but with such different responses to the infection, illustrates how much is still to be learned about COVID-19, says Noopur Raje, MD, professor of medicine at Harvard Medical School and director of the Center for Multiple Myeloma at Massachusetts General Hospital (MGH) in Boston.

“After experiencing #Covid_19 from the patient/caregiver end despite both of us being physicians at a major academic medical center, this has been a challenge like no other I have experienced,” Raje (@NoopurRajeMD) wrote on Twitter.

She outlined their experiences in a Twitter thread and elaborated in an interview with Medscape Medical News.

Raje says that she wants clinicians to know how symptoms can evolve both quickly and suddenly.

She recalls how for 10 days, she cared for her COVID-19–positive husband at home, separated from him by a floor in their Boston townhouse and wearing a surgical mask and gloves to bring him food and fluids, as he was too weak to help himself.

Despite the high fevers, chills, extreme fatigue, and dramatic weight loss, Raje says she felt reasonably confident that her husband was getting better. His temperature had dropped from around 103 to 101, his heart rate was in the 80s, and his blood pressure was “OK,” she recalls.

But then Jag Singh, MD, an otherwise healthy 55-year-old Harvard professor and cardiologist, started to cough — and everything suddenly changed.

The cough sounded chesty, and he was weak and unwell. They decided that he needed medical help.

“I was planning on driving him to the hospital, but I ended up having to call 911, although we literally live across the street,” she said.

“We have stairs here and I wasn’t sure that he would be able to make it coming down with me trying to help him, so the safest thing was for me to call for help.”

Singh was admitted straight to the medical intensive care unit (MICU) while his wife waited at home.

“I was blown away when I saw Jag’s x-ray and CT scan and the bilateral pneumonia he had developed,” she commented. “I would not have believed it, the way he was clinically — and seeing that x-ray.

“Honestly, when I took him in to hospital, I thought he’d be there a couple of days — over the weekend — and I’d get him back Monday. But it didn’t turn out that way. He was there for about 9 days.”

That first night in the hospital, Singh consented to intubation — should he need it. “He called me then,” said Raje. “I said we’ve got to do what we’ve got to do, it’s OK — it is what it is, and we’ll do whatever it takes.”

He remained in the MICU overnight and through the next day, still breathing on his own, but with the looming prospect of mechanical ventilation.

“The good news is he maintained his oxygen saturations throughout,” said Raje. “I was able to see his vitals with EPIC [remote monitoring] ... It was crazy,” she recalls. “Seeing a respiratory rate of 26 was difficult. When you see that, you worry about somebody tiring with the breathing. His inflammatory markers kept climbing, his fevers persisted.”

Thankfully, he never needed the ventilator.

But by this time Raje had another worry: She, too, had tested positive and was now alone at home.

“I was unable to talk to my extended family as they all looked to us as physicians for support,” she tweeted. Both children came to Boston to see her, but she saw them only through a window.

Alone, she waited for the same symptoms that had slammed her husband; but they never came — something she wants caregivers to know.

“The fear and anxiety of taking care of somebody who’s COVID positive ... I am hoping that can be alleviated a little bit at least,” she said. “If you’ve been taking care of someone, chances are you’re probably positive already and if you’re not sick, the chances of you getting sick are really low, so don’t be afraid to take care of that person.”

Singh is recovering well at home now, almost a month into his illness. During the interview, conducted via Zoom, he could be heard coughing in the background.

While in the MICU, Singh was treated with azithromycin and hydroxychloroquine — standard at MGH for critically ill COVID-19 patients — and he was also enrolled into a double-blind, randomized, placebo-controlled trial of the investigational agent remdesivir (Gilead).

Raje is not sure what, if anything, helped him turn the corner.

“I saw his inflammatory markers get worse actually — I don’t think we can know if the drugs made a difference,” she says. “His first dose of hydroxychloroquine was Friday night when he was admitted, and the markers continued to climb until the next Thursday.”

In particular, his C-reactive protein (CRP) kept rising, reaching the 260 to 270 mg/dL range, “which to me was scary,” she said. “I do think he had a cytokine storm going, but I didn’t see those results.”

“Understanding the immune compartment is going to be so, so critically important and what it is that we can do to boost folks’ immune systems,” she said.

“If you have a very high viral load and your immune system is not 100% even though you’re otherwise healthy, you might be the person who ends up with that more serious response to this virus. Trying to study this in a focused way, looking at the immune compartment, looking at the antibody status, looking at the viral load — there’s so much more we need to look at. Until we get the vaccine, which is probably a year-and-a-half away, we need to look at how can we develop that herd immunity so we don’t have folks getting as critically ill as they do.”

Despite feeling perfectly healthy, Raje is still at home. Three weeks after her first test, she is still testing positive for COVID-19, waiting for two consecutive negative results 72 hours apart before she is allowed back to work at the hospital.

When she gets the green light, she plans to go work on the COVID-19 floor, if needed. “It’s people like us [who have had COVID-19] who have to get back in the trenches and do the work now,” she says.

“My biggest concern is that it’s a very isolating experience for the COVID-positive patient. We are doing complete-barrier nursing — they are completely alone. The only person who ever walks into the room is the nurse — and the physician goes in once a day. It’s so important that we don’t lose sight of compassion,” she says.

“That’s why, in terms of alleviating anxiety, it is so important we do antibody testing so that people can actually go in and take care of these folks.”

‘Look for red flag’

Raje wants physicians to warn their self-isolating patients and caregivers to look for red flags. “There are primary care physicians who reached out to me [after my tweets] and said ‘when someone calls me and says it’s been 5-7 days and I am still not feeling well, I am going to look at that more seriously.’

“Part of me wanting to share this experience was basically to dispel the notion that 2 weeks into this you’re going to be fine,” she said, because it is not widely appreciated, she feels that “in week 2, you could become pretty sick.”

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

dbrunk@mdedge.com

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

dbrunk@mdedge.com

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

dbrunk@mdedge.com

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five office locations located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ‘Do you have any reason to worry about yourself? If so, please call us.’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger, who is also founder and executive chairman of United Rheumatology, which is a nationwide rheumatology care management services organization with 650 members in 39 states. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’ ‘What are all the six degrees of separation here?’ I want to know what the patient’s husband did last night. I want to know where their kids were over this past week, et cetera. We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the CDC’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the Centers for Disease Control and Prevention, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.

Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will only be treated 14 days after the all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

In Aventura, Fla., Norman B. Gaylis, MD, and his colleagues at Arthritis & Rheumatic Disease Specialties are looking into shutting down their infusion services during the time period that local public health officials consider to be the peak level of exposure to COVID-19. “We’ve tried to work around that, and bring people in a little early,” said Dr. Gaylis, medical director of rheumatology and infusion services at the practice. “We’ve done our best to mitigate the risk [of exposure] as much as possible.” This includes staggering their caseload by infusing 5 patients at a time, compared with the 15 patients at a time they could treat during prepandemic conditions. “Everyone is at least 20 feet apart,” said Dr. Gaylis, who is a member of the American College of Rheumatology Board of Directors. “While we don’t have the kind of protective garments you might see in an ICU, we still are gowning, gloving, and masking our staff, and trying to practice sterile techniques as much as we can.”

The pandemic has caused him to reflect more broadly on the way he and his colleagues deliver care for patients on infusion therapy. “We see patients who really want their treatment because they feel it’s helpful and beneficial,” he said. “There are also patients who may truly be in remission who could stop [infusion therapy]. We could possibly extend the duration of their therapy, try and push it back.”

Dr. Gaylis emphasized that any discussion about halting infusion therapy requires clinical, serological, and ideally even MRI evidence that the disease is in a dormant state. “You wouldn’t stop treatment in someone who is showing signs in their blood that their disease is still active,” he said. “You’re using all those parameters in that conversation.”

In his clinical opinion, now is not the time to switch patients to self-injectable agents as a perceived matter of convenience. “I don’t really think that’s a good idea because self-injectables are different,” Dr. Gaylis said. “You’re basically switching treatment patterns. The practicality of getting a specialty pharmacy to switch, the insurance companies to cover it, and determine copay for it, is a burden on patients. That’s why I’m against it, because you’re starting a whole new process and problem.”

One patient tested positive for COVID-19 about 3 weeks after an infusion at the facility. “That does lead to a point: Have my staff been tested? We have not had the tests available to us,” Dr. Gaylis said. “One provider had a contact with someone with COVID-19 and stayed home for 2 weeks. That person tested negative. Soon we are going to receive a kit that will allow us to measure IgM and IgG COVID-19 antibodies. Because we’re going to be closed for 2 weeks, measuring us now would be a great way to handle it.”

In rural Western Kentucky, Christopher R. Phillips, MD, and his colleagues at Paducah Rheumatology have arranged for “drive-by” injections for some of their higher-risk patients who require subcutaneous administration of biologic agents. “We have them call us when they’re in the parking lot, and we give them the treatment while they sit in their car,” said Dr. Phillips, who chairs the ACR Insurance Subcommittee and is a member of the ACR COVID-19 Practice and Advocacy Task Force.

For patients who require infusions, they’ve arranged three chairs in the clinic to be at least 6 feet apart, and moved the fourth chair into a separate room. “My infusion nurse knows these patients well; we’re a small community,” he said. “She checks in with them the day before to screen for any symptoms of infection and asks them to call when they get here. A lot of them wait in their car to be brought in. She’ll bring them in, screen for infection symptoms, and check their temperature. She and the receptionist are masked and gloved, and disinfect aggressively between patients. The other thing we are trying to be on top of is making sure that everyone’s insurance coverage is active when they come in, in light of the number of people who have been laid off or had changes in their employment.”

Dr. Phillips has considered increasing the infusion time interval for some patients, but not knowing when current physical distancing guidelines will ease up presents a conundrum. “If I have a patient coming in today, and their next treatment is due in a month, I don’t know how to say that, if we stretch the infusion to 2 months, that things are going to be better,” he said. “For some very well-controlled patients and/or high-risk patients, that is something we’ve done: stretch the interval or skip a treatment. For most patients, our default is to stick with the normal schedule. We feel that, for most patients who have moderate to severe underlying rheumatic disease, the risk of disease flare and subsequent need for steroids may be a larger risk than the treatment itself, though that is an individualized decision.”

To date, Dr. Phillips has not treated a patient who has recovered from COVID-19, but the thought of that scenario gives him pause. “There is some literature suggesting these patients may asymptomatically shed virus for some time after they’ve clinically recovered, but we don’t really know enough about that,” he said. “If I had one of those patients, I’d probably be delaying them for a longer period of time, and I’d be looking for some guidance from the literature on postsymptomatic viral shedding.”

In the meantime, the level of anxiety that many of his patients express during this pandemic is palpable. “They really are between a rock and a hard place,” Dr. Phillips said. “If they come off their effective treatment, they risk flare of a disease that can be life or limb threatening. And yet, because of their disease and their treatment, they’re potentially at increased risk for serious illness if they become infected with COVID-19. We look for ways to try to reassure patients and to comfort them, and work with them to make the best of the situation.”

dbrunk@mdedge.com

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five office locations located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ‘Do you have any reason to worry about yourself? If so, please call us.’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger, who is also founder and executive chairman of United Rheumatology, which is a nationwide rheumatology care management services organization with 650 members in 39 states. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’ ‘What are all the six degrees of separation here?’ I want to know what the patient’s husband did last night. I want to know where their kids were over this past week, et cetera. We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the CDC’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the Centers for Disease Control and Prevention, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.

Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will only be treated 14 days after the all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

In Aventura, Fla., Norman B. Gaylis, MD, and his colleagues at Arthritis & Rheumatic Disease Specialties are looking into shutting down their infusion services during the time period that local public health officials consider to be the peak level of exposure to COVID-19. “We’ve tried to work around that, and bring people in a little early,” said Dr. Gaylis, medical director of rheumatology and infusion services at the practice. “We’ve done our best to mitigate the risk [of exposure] as much as possible.” This includes staggering their caseload by infusing 5 patients at a time, compared with the 15 patients at a time they could treat during prepandemic conditions. “Everyone is at least 20 feet apart,” said Dr. Gaylis, who is a member of the American College of Rheumatology Board of Directors. “While we don’t have the kind of protective garments you might see in an ICU, we still are gowning, gloving, and masking our staff, and trying to practice sterile techniques as much as we can.”

The pandemic has caused him to reflect more broadly on the way he and his colleagues deliver care for patients on infusion therapy. “We see patients who really want their treatment because they feel it’s helpful and beneficial,” he said. “There are also patients who may truly be in remission who could stop [infusion therapy]. We could possibly extend the duration of their therapy, try and push it back.”

Dr. Gaylis emphasized that any discussion about halting infusion therapy requires clinical, serological, and ideally even MRI evidence that the disease is in a dormant state. “You wouldn’t stop treatment in someone who is showing signs in their blood that their disease is still active,” he said. “You’re using all those parameters in that conversation.”

In his clinical opinion, now is not the time to switch patients to self-injectable agents as a perceived matter of convenience. “I don’t really think that’s a good idea because self-injectables are different,” Dr. Gaylis said. “You’re basically switching treatment patterns. The practicality of getting a specialty pharmacy to switch, the insurance companies to cover it, and determine copay for it, is a burden on patients. That’s why I’m against it, because you’re starting a whole new process and problem.”

One patient tested positive for COVID-19 about 3 weeks after an infusion at the facility. “That does lead to a point: Have my staff been tested? We have not had the tests available to us,” Dr. Gaylis said. “One provider had a contact with someone with COVID-19 and stayed home for 2 weeks. That person tested negative. Soon we are going to receive a kit that will allow us to measure IgM and IgG COVID-19 antibodies. Because we’re going to be closed for 2 weeks, measuring us now would be a great way to handle it.”

In rural Western Kentucky, Christopher R. Phillips, MD, and his colleagues at Paducah Rheumatology have arranged for “drive-by” injections for some of their higher-risk patients who require subcutaneous administration of biologic agents. “We have them call us when they’re in the parking lot, and we give them the treatment while they sit in their car,” said Dr. Phillips, who chairs the ACR Insurance Subcommittee and is a member of the ACR COVID-19 Practice and Advocacy Task Force.

For patients who require infusions, they’ve arranged three chairs in the clinic to be at least 6 feet apart, and moved the fourth chair into a separate room. “My infusion nurse knows these patients well; we’re a small community,” he said. “She checks in with them the day before to screen for any symptoms of infection and asks them to call when they get here. A lot of them wait in their car to be brought in. She’ll bring them in, screen for infection symptoms, and check their temperature. She and the receptionist are masked and gloved, and disinfect aggressively between patients. The other thing we are trying to be on top of is making sure that everyone’s insurance coverage is active when they come in, in light of the number of people who have been laid off or had changes in their employment.”

Dr. Phillips has considered increasing the infusion time interval for some patients, but not knowing when current physical distancing guidelines will ease up presents a conundrum. “If I have a patient coming in today, and their next treatment is due in a month, I don’t know how to say that, if we stretch the infusion to 2 months, that things are going to be better,” he said. “For some very well-controlled patients and/or high-risk patients, that is something we’ve done: stretch the interval or skip a treatment. For most patients, our default is to stick with the normal schedule. We feel that, for most patients who have moderate to severe underlying rheumatic disease, the risk of disease flare and subsequent need for steroids may be a larger risk than the treatment itself, though that is an individualized decision.”

To date, Dr. Phillips has not treated a patient who has recovered from COVID-19, but the thought of that scenario gives him pause. “There is some literature suggesting these patients may asymptomatically shed virus for some time after they’ve clinically recovered, but we don’t really know enough about that,” he said. “If I had one of those patients, I’d probably be delaying them for a longer period of time, and I’d be looking for some guidance from the literature on postsymptomatic viral shedding.”

In the meantime, the level of anxiety that many of his patients express during this pandemic is palpable. “They really are between a rock and a hard place,” Dr. Phillips said. “If they come off their effective treatment, they risk flare of a disease that can be life or limb threatening. And yet, because of their disease and their treatment, they’re potentially at increased risk for serious illness if they become infected with COVID-19. We look for ways to try to reassure patients and to comfort them, and work with them to make the best of the situation.”

dbrunk@mdedge.com

It’s anything but business as usual for clinicians who oversee office-based infusion centers, as they scramble to maintain services for patients considered to be at heightened risk for severe illness should they become infected with COVID-19.

Courtesy Dr. Alyssa M. Parian

“For many reasons, the guidance for patients right now is that they stay on their medications,” Max I. Hamburger, MD, a managing partner at Rheumatology Associates of Long Island (N.Y.), said in an interview. “Some have decided to stop the drug, and then they call us up to tell us that they’re flaring. The beginning of a flare is tiredness and other things. Now they’re worried: Are they tired because of the disease, or are they tired because they have COVID-19?”

With five office locations located in a region considered to be the epicenter of the COVID-19 pandemic in the United States, Dr. Hamburger and his colleagues are hypervigilant about screening patients for symptoms of the virus before they visit one of the three practice locations that provide infusion services. This starts with an automated phone system that reminds patients of their appointment time. “Part of that robocall now has some questions like, ‘Do you have any symptoms of COVID-19?’ ‘Are you running a fever?’ ‘Do you have any reason to worry about yourself? If so, please call us.’ ” The infusion nurses are also calling the patients in advance of their appointment to check on their status. “When they get to the office location, we ask them again about their general health and check their temperature,” said Dr. Hamburger, who is also founder and executive chairman of United Rheumatology, which is a nationwide rheumatology care management services organization with 650 members in 39 states. “We’re doing everything we can to talk to them about their own state of health and to question them about what I call extended paranoia: like, ‘Who are you living with?’ ‘Who are you hanging out with?’ ‘What are all the six degrees of separation here?’ I want to know what the patient’s husband did last night. I want to know where their kids were over this past week, et cetera. We do everything we can to see if there’s anybody who might have had the slightest [contact with someone who has COVID-19]. Because if I lose my infusion nurse, then I’m up the creek.”

The infusion nurse wears scrubs, a face mask, and latex gloves. She and her staff are using hand sanitizer and cleaning infusion equipment with sanitizing wipes as one might do in a surgical setting. “Every surface is wiped down between patients, and the nurse is changing gloves between patients,” said Dr. Hamburger, who was founding president of the New York State Rheumatology Society before retiring from that post in 2017. “Getting masks has been tough. We’re doing the best we can there. We’re not gloving patients but we’re masking patients.”

As noted in guidance from the American College of Rheumatology and other medical organizations, following the CDC’s recommendation to stay at home during the pandemic has jump-started conversations between physicians and their patients about modifying the time interval between infusions. “If they have been doing well for the last 9 months, we’re having a conversation such as ‘Maybe instead of getting your Orencia every 4 weeks, maybe we’ll push it out to 5 weeks, or maybe we’ll push the Enbrel out to 10 days and the Humira out 3 weeks, et cetera,” Dr. Hamburger said. “One has to be very careful about when you do that, because you don’t want the patient to flare up because it’s hard to get them in, but it is a natural opportunity to look at this. We’re seeing how we can optimize the dose, but I don’t want to send the message that we’re doing this because it changes the patient’s outcome, because there’s zero evidence that it’s a good thing to do in terms of resistance.”

At the infusion centers operated by the Johns Hopkins division of gastroenterology and hepatology, Baltimore, clinicians are not increasing the time interval between infusions for patients at this time. “We’re keeping them as they are, to prevent any flare-ups. Our main goal is to keep patients in remission and out of the hospital,” said Alyssa M. Parian, MD, medical director of the infusion center and associate director of the university’s GI department. “With Remicade specifically, there’s also the risk of developing antibodies if you delay treatment, so we’re basically keeping everyone on track. We’re not recommending a switch from infusions to injectables, and we also are not speeding up infusions, either. Before this pandemic happened, we had already tried to decrease all Remicade infusions from 2 hours to 1 hour for patient satisfaction. The Entyvio is a pretty quick, 30-minute infusion.”

To accommodate patients during this era of physical distancing measures recommended by the Centers for Disease Control and Prevention, Dr. Parian and her infusion nurse manager Elisheva Weiser converted one of their two outpatient GI centers into an infusion-only suite with 12 individual clinic rooms. As soon as patients exit the second-floor elevator, they encounter a workstation prior to entering the office where they are screened for COVID-19 symptoms and their temperature is taken. “If any symptoms or temperature comes back positive, we’re asking them to postpone their treatment and consider COVID testing,” she said.

Instead of one nurse looking after four patients in one room during infusion therapy, now one nurse looks after two patients who are in rooms next to each other. All patients and all staff wear masks while in the center. “We always have physician oversight at our infusion centers,” Dr. Parian said. “We are trying to maintain a ‘COVID-free zone.’ Therefore, no physicians who have served in a hospital ward are allowed in the infusion suite because we don’t want any carriers of COVID-19. Same with the nurses. Additionally, we limit the staff within the suite to only those who are essential and don’t allow anyone to perform telemedicine or urgent clinic visits in this location. Our infusion center staff are on a strict protocol to not come in with any symptoms at all. They are asked to take their temperature before coming in to work.”

She and her colleagues drew from recommendations from the joint GI society message on COVID-19, the Crohn’s and Colitis Foundation, and the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to inform their approach in serving patients during this unprecedented time. “We went as conservative as possible because these are immunosuppressed patients,” she said. One patient on her panel who receives an infusion every 8 weeks tested positive for COVID-19 between infusions, but was not hospitalized. Dr. Parian said that person will only be treated 14 days after the all symptoms disappear. “That person will wear a mask and will be infused in a separate room,” she said.

In Aventura, Fla., Norman B. Gaylis, MD, and his colleagues at Arthritis & Rheumatic Disease Specialties are looking into shutting down their infusion services during the time period that local public health officials consider to be the peak level of exposure to COVID-19. “We’ve tried to work around that, and bring people in a little early,” said Dr. Gaylis, medical director of rheumatology and infusion services at the practice. “We’ve done our best to mitigate the risk [of exposure] as much as possible.” This includes staggering their caseload by infusing 5 patients at a time, compared with the 15 patients at a time they could treat during prepandemic conditions. “Everyone is at least 20 feet apart,” said Dr. Gaylis, who is a member of the American College of Rheumatology Board of Directors. “While we don’t have the kind of protective garments you might see in an ICU, we still are gowning, gloving, and masking our staff, and trying to practice sterile techniques as much as we can.”

The pandemic has caused him to reflect more broadly on the way he and his colleagues deliver care for patients on infusion therapy. “We see patients who really want their treatment because they feel it’s helpful and beneficial,” he said. “There are also patients who may truly be in remission who could stop [infusion therapy]. We could possibly extend the duration of their therapy, try and push it back.”

Dr. Gaylis emphasized that any discussion about halting infusion therapy requires clinical, serological, and ideally even MRI evidence that the disease is in a dormant state. “You wouldn’t stop treatment in someone who is showing signs in their blood that their disease is still active,” he said. “You’re using all those parameters in that conversation.”

In his clinical opinion, now is not the time to switch patients to self-injectable agents as a perceived matter of convenience. “I don’t really think that’s a good idea because self-injectables are different,” Dr. Gaylis said. “You’re basically switching treatment patterns. The practicality of getting a specialty pharmacy to switch, the insurance companies to cover it, and determine copay for it, is a burden on patients. That’s why I’m against it, because you’re starting a whole new process and problem.”

One patient tested positive for COVID-19 about 3 weeks after an infusion at the facility. “That does lead to a point: Have my staff been tested? We have not had the tests available to us,” Dr. Gaylis said. “One provider had a contact with someone with COVID-19 and stayed home for 2 weeks. That person tested negative. Soon we are going to receive a kit that will allow us to measure IgM and IgG COVID-19 antibodies. Because we’re going to be closed for 2 weeks, measuring us now would be a great way to handle it.”

In rural Western Kentucky, Christopher R. Phillips, MD, and his colleagues at Paducah Rheumatology have arranged for “drive-by” injections for some of their higher-risk patients who require subcutaneous administration of biologic agents. “We have them call us when they’re in the parking lot, and we give them the treatment while they sit in their car,” said Dr. Phillips, who chairs the ACR Insurance Subcommittee and is a member of the ACR COVID-19 Practice and Advocacy Task Force.

For patients who require infusions, they’ve arranged three chairs in the clinic to be at least 6 feet apart, and moved the fourth chair into a separate room. “My infusion nurse knows these patients well; we’re a small community,” he said. “She checks in with them the day before to screen for any symptoms of infection and asks them to call when they get here. A lot of them wait in their car to be brought in. She’ll bring them in, screen for infection symptoms, and check their temperature. She and the receptionist are masked and gloved, and disinfect aggressively between patients. The other thing we are trying to be on top of is making sure that everyone’s insurance coverage is active when they come in, in light of the number of people who have been laid off or had changes in their employment.”

Dr. Phillips has considered increasing the infusion time interval for some patients, but not knowing when current physical distancing guidelines will ease up presents a conundrum. “If I have a patient coming in today, and their next treatment is due in a month, I don’t know how to say that, if we stretch the infusion to 2 months, that things are going to be better,” he said. “For some very well-controlled patients and/or high-risk patients, that is something we’ve done: stretch the interval or skip a treatment. For most patients, our default is to stick with the normal schedule. We feel that, for most patients who have moderate to severe underlying rheumatic disease, the risk of disease flare and subsequent need for steroids may be a larger risk than the treatment itself, though that is an individualized decision.”

To date, Dr. Phillips has not treated a patient who has recovered from COVID-19, but the thought of that scenario gives him pause. “There is some literature suggesting these patients may asymptomatically shed virus for some time after they’ve clinically recovered, but we don’t really know enough about that,” he said. “If I had one of those patients, I’d probably be delaying them for a longer period of time, and I’d be looking for some guidance from the literature on postsymptomatic viral shedding.”

In the meantime, the level of anxiety that many of his patients express during this pandemic is palpable. “They really are between a rock and a hard place,” Dr. Phillips said. “If they come off their effective treatment, they risk flare of a disease that can be life or limb threatening. And yet, because of their disease and their treatment, they’re potentially at increased risk for serious illness if they become infected with COVID-19. We look for ways to try to reassure patients and to comfort them, and work with them to make the best of the situation.”

dbrunk@mdedge.com