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FDA issues warning on fecal transplant transmission of SARS-CoV-2
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
COVID-19 critical care guideline offers support for frontline clinicians
The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.
Useful guide nonspecialists
Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).
“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”
“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.
Perhaps the only potentially controversial aspect of the guidelines are a couple of weak recommendations that suggest using a high-flow nasal cannula (HFNC) rather than noninvasive positive pressure ventilation (NIPPV) in patients with acute hypoxemic respiratory failure who have not fully responded to conventional oxygen therapy. “This is controversial, and some of my colleagues are debating this,” said Dr. Narasimhan, but she noted that her clinic has decided to follow the recommended preference for HFNC, which seemed to have modest advantages over NIPPV in a recent meta-analysis (Intensive Care Med. 2019 May;45[5]:563-72).
Another issue with NIPPV is the higher risk for viral dispersion it seems to have, compared with a HFNC, said Dr. Ferraro. If a patient’s mask comes off during NIPPV, it creates a substantial risk for aerosolization of virus. That risk is likely lower with HFNC, especially a HFNC system that uses a small cannula without heating or humidification of the gas flow. “I’d recommend against NIPPV,” Dr. Ferraro said.
He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”
One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.
“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.
Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.
The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.
Useful guide nonspecialists
Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).
“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”
“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.
Perhaps the only potentially controversial aspect of the guidelines are a couple of weak recommendations that suggest using a high-flow nasal cannula (HFNC) rather than noninvasive positive pressure ventilation (NIPPV) in patients with acute hypoxemic respiratory failure who have not fully responded to conventional oxygen therapy. “This is controversial, and some of my colleagues are debating this,” said Dr. Narasimhan, but she noted that her clinic has decided to follow the recommended preference for HFNC, which seemed to have modest advantages over NIPPV in a recent meta-analysis (Intensive Care Med. 2019 May;45[5]:563-72).
Another issue with NIPPV is the higher risk for viral dispersion it seems to have, compared with a HFNC, said Dr. Ferraro. If a patient’s mask comes off during NIPPV, it creates a substantial risk for aerosolization of virus. That risk is likely lower with HFNC, especially a HFNC system that uses a small cannula without heating or humidification of the gas flow. “I’d recommend against NIPPV,” Dr. Ferraro said.
He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”
One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.
“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.
Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.
The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.
Useful guide nonspecialists
Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).
“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”
“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.
Perhaps the only potentially controversial aspect of the guidelines are a couple of weak recommendations that suggest using a high-flow nasal cannula (HFNC) rather than noninvasive positive pressure ventilation (NIPPV) in patients with acute hypoxemic respiratory failure who have not fully responded to conventional oxygen therapy. “This is controversial, and some of my colleagues are debating this,” said Dr. Narasimhan, but she noted that her clinic has decided to follow the recommended preference for HFNC, which seemed to have modest advantages over NIPPV in a recent meta-analysis (Intensive Care Med. 2019 May;45[5]:563-72).
Another issue with NIPPV is the higher risk for viral dispersion it seems to have, compared with a HFNC, said Dr. Ferraro. If a patient’s mask comes off during NIPPV, it creates a substantial risk for aerosolization of virus. That risk is likely lower with HFNC, especially a HFNC system that uses a small cannula without heating or humidification of the gas flow. “I’d recommend against NIPPV,” Dr. Ferraro said.
He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”
One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.
“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.
Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.
Three COVID-19 rapid diagnostic tests get FDA thumbs-up
The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.
The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.
The company plans to roll out the test by March 30, according to the FDA.
Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.
FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.
The test was developed with funding from the U.S. Department of Defense.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.
Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.
The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”
Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.
“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe
that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.
The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.
The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.
The company plans to roll out the test by March 30, according to the FDA.
Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.
FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.
The test was developed with funding from the U.S. Department of Defense.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.
Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.
The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”
Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.
“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe
that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.
The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.
The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.
The company plans to roll out the test by March 30, according to the FDA.
Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.
FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.
The test was developed with funding from the U.S. Department of Defense.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.
Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.
The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”
Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.
“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe
that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.
Reports increasingly suggest anosmia/hyposmia can signal early COVID-19 infection
Unexplained anosmia, hyposmia, and dysgeusia should be added to the list of possible COVID-19 symptoms for screening purposes, and individuals with such symptoms should consider self-isolation, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) has proposed.
However, a World Health Organization expert said during a March 23 daily briefing on the novel coronavirus pandemic that the jury is still out on that.
The AAO-HNS proposal is based on “rapidly accumulating” anecdotal evidence that such symptoms – in the absence of other symptoms suggestive of COVID-19 – have sometimes preceded a COVID-19 diagnosis.
“ ... anosmia, hyposmia, and dysgeusia in the absence of other respiratory disease such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis should alert physicians to the possibility of COVID-19 infection and warrant serious consideration for self-isolation and testing of these individuals,” the AAO-HNS said in a statement on the proposal.
ENT UK, an organization representing Ear, Nose, and Throat surgery and its related specialties in the UK, also is emphasizing the potential importance of these symptoms. In a March 21 letter, ENT UK experts cited “good evidence from South Korea, China and Italy that significant numbers of patients with proven COVID-19 infection have developed anosmia/hyposmia.”
Claire Hopkins, BMBCh, president of the British Rhinological Society and a professor of Rhinology at King’s College London, along with ENT UK president Nirmal Kumar, also noted in the letter that two of every three cases in Germany, and 30% of patients testing positive in South Korea, had anosmia as their first symptom.
“While there is a chance the apparent increase in incidence could merely reflect the attention COVID-19 has attracted in the media, and that such cases may be caused by typical rhinovirus and coronavirus strains, it could potentially be used as a screening tool to help identify otherwise asymptomatic patients, who could then be better instructed on self-isolation,” they wrote.
Maria Van Kerkhove, MD, technical lead of the WHO Medical Emergencies Program, acknowledged the anecdotal evidence during the WHO briefing.
“Yes, we’ve seen quite a few reports ... but this is something that we need to look into to really capture if this is one of the early signs and symptoms of COVID-19,” she said, noting that WHO is working with more than a dozen countries that are systematically collecting data using molecular and serological testing to “capture more robustly” the early signs and symptoms, and is “reaching out to a number of countries and looking at the cases that have already been reported to see if [anosmia] is a common feature.”
“We don’t have the answer to that,” she said, adding that, in addition to the major symptoms – including dry cough, fever, and shortness of breath – that are well known at this point, “there are likely to be many signs and symptoms that people have.”
“A loss of smell or a loss of taste is something that we’re looking into, and we’re looking forward to the results of these early investigations ... so that we have a more evidence-based approach and we can add that to the list.”
Unexplained anosmia, hyposmia, and dysgeusia should be added to the list of possible COVID-19 symptoms for screening purposes, and individuals with such symptoms should consider self-isolation, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) has proposed.
However, a World Health Organization expert said during a March 23 daily briefing on the novel coronavirus pandemic that the jury is still out on that.
The AAO-HNS proposal is based on “rapidly accumulating” anecdotal evidence that such symptoms – in the absence of other symptoms suggestive of COVID-19 – have sometimes preceded a COVID-19 diagnosis.
“ ... anosmia, hyposmia, and dysgeusia in the absence of other respiratory disease such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis should alert physicians to the possibility of COVID-19 infection and warrant serious consideration for self-isolation and testing of these individuals,” the AAO-HNS said in a statement on the proposal.
ENT UK, an organization representing Ear, Nose, and Throat surgery and its related specialties in the UK, also is emphasizing the potential importance of these symptoms. In a March 21 letter, ENT UK experts cited “good evidence from South Korea, China and Italy that significant numbers of patients with proven COVID-19 infection have developed anosmia/hyposmia.”
Claire Hopkins, BMBCh, president of the British Rhinological Society and a professor of Rhinology at King’s College London, along with ENT UK president Nirmal Kumar, also noted in the letter that two of every three cases in Germany, and 30% of patients testing positive in South Korea, had anosmia as their first symptom.
“While there is a chance the apparent increase in incidence could merely reflect the attention COVID-19 has attracted in the media, and that such cases may be caused by typical rhinovirus and coronavirus strains, it could potentially be used as a screening tool to help identify otherwise asymptomatic patients, who could then be better instructed on self-isolation,” they wrote.
Maria Van Kerkhove, MD, technical lead of the WHO Medical Emergencies Program, acknowledged the anecdotal evidence during the WHO briefing.
“Yes, we’ve seen quite a few reports ... but this is something that we need to look into to really capture if this is one of the early signs and symptoms of COVID-19,” she said, noting that WHO is working with more than a dozen countries that are systematically collecting data using molecular and serological testing to “capture more robustly” the early signs and symptoms, and is “reaching out to a number of countries and looking at the cases that have already been reported to see if [anosmia] is a common feature.”
“We don’t have the answer to that,” she said, adding that, in addition to the major symptoms – including dry cough, fever, and shortness of breath – that are well known at this point, “there are likely to be many signs and symptoms that people have.”
“A loss of smell or a loss of taste is something that we’re looking into, and we’re looking forward to the results of these early investigations ... so that we have a more evidence-based approach and we can add that to the list.”
Unexplained anosmia, hyposmia, and dysgeusia should be added to the list of possible COVID-19 symptoms for screening purposes, and individuals with such symptoms should consider self-isolation, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) has proposed.
However, a World Health Organization expert said during a March 23 daily briefing on the novel coronavirus pandemic that the jury is still out on that.
The AAO-HNS proposal is based on “rapidly accumulating” anecdotal evidence that such symptoms – in the absence of other symptoms suggestive of COVID-19 – have sometimes preceded a COVID-19 diagnosis.
“ ... anosmia, hyposmia, and dysgeusia in the absence of other respiratory disease such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis should alert physicians to the possibility of COVID-19 infection and warrant serious consideration for self-isolation and testing of these individuals,” the AAO-HNS said in a statement on the proposal.
ENT UK, an organization representing Ear, Nose, and Throat surgery and its related specialties in the UK, also is emphasizing the potential importance of these symptoms. In a March 21 letter, ENT UK experts cited “good evidence from South Korea, China and Italy that significant numbers of patients with proven COVID-19 infection have developed anosmia/hyposmia.”
Claire Hopkins, BMBCh, president of the British Rhinological Society and a professor of Rhinology at King’s College London, along with ENT UK president Nirmal Kumar, also noted in the letter that two of every three cases in Germany, and 30% of patients testing positive in South Korea, had anosmia as their first symptom.
“While there is a chance the apparent increase in incidence could merely reflect the attention COVID-19 has attracted in the media, and that such cases may be caused by typical rhinovirus and coronavirus strains, it could potentially be used as a screening tool to help identify otherwise asymptomatic patients, who could then be better instructed on self-isolation,” they wrote.
Maria Van Kerkhove, MD, technical lead of the WHO Medical Emergencies Program, acknowledged the anecdotal evidence during the WHO briefing.
“Yes, we’ve seen quite a few reports ... but this is something that we need to look into to really capture if this is one of the early signs and symptoms of COVID-19,” she said, noting that WHO is working with more than a dozen countries that are systematically collecting data using molecular and serological testing to “capture more robustly” the early signs and symptoms, and is “reaching out to a number of countries and looking at the cases that have already been reported to see if [anosmia] is a common feature.”
“We don’t have the answer to that,” she said, adding that, in addition to the major symptoms – including dry cough, fever, and shortness of breath – that are well known at this point, “there are likely to be many signs and symptoms that people have.”
“A loss of smell or a loss of taste is something that we’re looking into, and we’re looking forward to the results of these early investigations ... so that we have a more evidence-based approach and we can add that to the list.”
CDC coronavirus testing decision likely to haunt nation for months to come
As the novel coronavirus snaked its way across the globe, the Centers for Disease Control and Prevention in early February distributed 200 test kits it had produced to more than 100 public health labs run by states and counties nationwide.
Each kit contained material to test a mere 300-400 patients. And labs, whether serving the population of New York or tiny towns in rural America, apparently received the same kits.
The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.
A woman in South Dakota with mild symptoms and no fever readily got the test and the results. Meanwhile, political leaders and public officials in places like New York, Boston, Seattle, and the San Francisco Bay area – all in the throes of serious outbreaks – couldn’t get enough tests to screen ill patients or, thereby, the information they needed to protect the general public and stem the outbreak of the virus, whose symptoms mimic those of common respiratory illnesses.
Rapid testing is crucial in the early stages of an outbreak. It allows health workers and families to identify and focus on treating those infected and isolate them.
Yet health officials in New York and such states as New York, Washington, Pennsylvania, and Georgia confirmed that they each initially got one test kit, calling into question whether they would have even stood a chance to contain the outbreaks that would emerge. They would soon discover that the tests they did receive were flawed, lacking critical components, and delivering faulty results.
During those early weeks, the virus took off, infecting thousands of people and leading to nationwide social distancing and sheltering in place. Public health officials are just beginning to grapple with the fallout from that early bungling of testing, which is likely to haunt the country in the months to come.
Too little too late
The first shipment to Washington state arrived more than 2 weeks after officials there announced the first U.S. case of coronavirus, and at a moment when deadly outbreaks of the disease were already festering in places like the Life Care Center in Kirkland. Within weeks, three dozen people infected with COVID-19 would die at the nursing home in the suburbs of Seattle.
The spread of COVID-19 would not take long to overwhelm the state, which as of March 20, 2020, had more than 1,300 cases.
The Trump administration in recent days has attempted to speed testing for the virus after early missteps hampered the government’s response to contain the contagion, and officials have had to respond to a barrage of criticism from public health experts, state officials, and members of Congress.
Federal health officials have eased the process for university and commercial labs to perform their own tests, and they are ramping up their capacity. As of March 16, public and private labs in the United States had the ability to test more than 36,000 people a day, according to estimates compiled by the American Enterprise Institute, a conservative-leaning think tank in Washington, a figure expected to rapidly escalate in coming weeks. That figure, however, can vary considerably by state and does not indicate how many tests are actually given to patients.
“We are now beginning to see that they have spread out in a prioritized way. We asked them to prioritize the regions that were mostly affected,” Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, said March 18 of private labs’ testing, without elaboration.
The scaling up of testing is set to take place after weeks of faltering and hundreds, if not thousands, of undiagnosed people spreading the virus. For example, New York’s state health department received a faulty CDC test kit on Feb. 8 for 800 patient specimens, an amount that’s consistent with other states, according to a spokesperson. It later began testing patients with a test that state officials developed based on the CDC protocol and has significantly increased testing – as of March 20, more than 7,200 people had tested positive statewide.
In New York City, the first batch was obtained on Feb. 7.
“The other state and local public health laboratories got test kits as they became available,” said Eric Blank, chief program officer of the Association of Public Health Laboratories.
Places in the middle of the country with no outbreaks had the luxury of time to plan. For example, Missouri officials have had about 800 tests to work with, leading to only 395 performed so far in the region by public health labs – 26 of which were positive. When private lab tests are accounted for, as of March 20 there were 47 confirmed cases.
Health care providers and public health staff in the state, however, benefited from the fact that there is less international travel to the region, according to infectious disease expert Steven Lawrence, MD, of Washington University, St. Louis.
“This is very similar to 1918 with the influenza pandemic – St. Louis had more time to prepare and was able to put measures in place to flatten the curve than, say, Philadelphia,” Dr. Lawrence said. “Seattle didn’t have an opportunity to prepare as much in advance.”
While commercial labs are coming online, strict restrictions are limiting testing capabilities, Dr. Lawrence said.
“The state has had their hands tied,” he added.
Waiting And wondering
Because of a widespread lag in testing, it is still a mystery for thousands of people to know whether they’ve come into contact with an infected person until well after it happens. As of March 20, the pandemic had killed more than 11,000 globally. More than 16,000 Americans were confirmed infected and at least 216 have died.
“CDC will distribute tests based on where they can do the most good. But without hospital-based testing and commercial testing, it will not be possible to meet the need,” said Tom Frieden, who led the CDC during President Obama’s administration and is a former commissioner of the New York City Health Department.
In California, public school teacher Claire Dugan, whose state was among the hardest hit in the initial wave of U.S. coronavirus cases, was told she didn’t qualify for testing because she had not traveled abroad to any country with an outbreak of the virus or been in contact with an infected person. Ms. Dugan, who lives in the San Francisco Bay area and is already medically fragile after a stray bullet nearly killed her while driving 4 years ago, sought a test from her doctor after registering a temperature of 100.7° F earlier this month.
“There are a lot of layers as to why this is so messed up,” said Ms. Dugan, who relies on a feeding tube and said she sought a test not only to protect herself but her students. “It’s community spreading right now, so it’s kind of silly we’re still insisting on [the early criteria for testing]. How would I know?”
Since the CDC’s initial distribution, states have been reordering more tests through the office’s International Reagent Resource – a long-standing tool that public health labs have relied on. They have also revised testing protocols to use only one sample per person, which boosts the number of people screened.
Yet problems still abound with tests or other materials needed to be able to detect the virus. California Gov. Gavin Newsom (D) said on March 12 that county public health labs can’t use all of the 8,000 test kits the state has because they are missing key components.
In Pennsylvania, state officials weren’t able to begin testing until March 2 because of problems with the CDC’s initial kit, according to Nate Wardle, a spokesperson at its department of health. New York received two newly manufactured CDC test kits on Feb. 29 and also began performing tests March 2, according to its health department.
“We are still limited on extraction kits,” Mandy Cohen, the Health & Human Services secretary in North Carolina, said in an interview in mid-March. Officials earlier this month could test only 300 patients because of shortages in the extraction materials needed to register whether the novel coronavirus is present.
In North Dakota, Loralyn Hegland wrote her physician’s practice an email on March 10 with the subject line “dry cough,” wondering if she should come in for testing after learning that was one symptom of COVID-19. The recommendation she got echoes those of countless others across the United States, saying her risk of being exposed was very low because she hadn’t traveled outside the United States and had not come into contact with a person who had been “definitely” diagnosed with the virus.
Ms. Hegland, who lives in Fargo, didn’t have a fever but decided to shelter herself, anyway, out of caution.
Would she push to get a test?
“What’s the point?” she said. “You can’t know what you don’t know. It’s just that simple. How else do you explain it to people when you’re not testing?”
KHN Midwest correspondent Lauren Weber in St. Louis contributed to this article.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
As the novel coronavirus snaked its way across the globe, the Centers for Disease Control and Prevention in early February distributed 200 test kits it had produced to more than 100 public health labs run by states and counties nationwide.
Each kit contained material to test a mere 300-400 patients. And labs, whether serving the population of New York or tiny towns in rural America, apparently received the same kits.
The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.
A woman in South Dakota with mild symptoms and no fever readily got the test and the results. Meanwhile, political leaders and public officials in places like New York, Boston, Seattle, and the San Francisco Bay area – all in the throes of serious outbreaks – couldn’t get enough tests to screen ill patients or, thereby, the information they needed to protect the general public and stem the outbreak of the virus, whose symptoms mimic those of common respiratory illnesses.
Rapid testing is crucial in the early stages of an outbreak. It allows health workers and families to identify and focus on treating those infected and isolate them.
Yet health officials in New York and such states as New York, Washington, Pennsylvania, and Georgia confirmed that they each initially got one test kit, calling into question whether they would have even stood a chance to contain the outbreaks that would emerge. They would soon discover that the tests they did receive were flawed, lacking critical components, and delivering faulty results.
During those early weeks, the virus took off, infecting thousands of people and leading to nationwide social distancing and sheltering in place. Public health officials are just beginning to grapple with the fallout from that early bungling of testing, which is likely to haunt the country in the months to come.
Too little too late
The first shipment to Washington state arrived more than 2 weeks after officials there announced the first U.S. case of coronavirus, and at a moment when deadly outbreaks of the disease were already festering in places like the Life Care Center in Kirkland. Within weeks, three dozen people infected with COVID-19 would die at the nursing home in the suburbs of Seattle.
The spread of COVID-19 would not take long to overwhelm the state, which as of March 20, 2020, had more than 1,300 cases.
The Trump administration in recent days has attempted to speed testing for the virus after early missteps hampered the government’s response to contain the contagion, and officials have had to respond to a barrage of criticism from public health experts, state officials, and members of Congress.
Federal health officials have eased the process for university and commercial labs to perform their own tests, and they are ramping up their capacity. As of March 16, public and private labs in the United States had the ability to test more than 36,000 people a day, according to estimates compiled by the American Enterprise Institute, a conservative-leaning think tank in Washington, a figure expected to rapidly escalate in coming weeks. That figure, however, can vary considerably by state and does not indicate how many tests are actually given to patients.
“We are now beginning to see that they have spread out in a prioritized way. We asked them to prioritize the regions that were mostly affected,” Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, said March 18 of private labs’ testing, without elaboration.
The scaling up of testing is set to take place after weeks of faltering and hundreds, if not thousands, of undiagnosed people spreading the virus. For example, New York’s state health department received a faulty CDC test kit on Feb. 8 for 800 patient specimens, an amount that’s consistent with other states, according to a spokesperson. It later began testing patients with a test that state officials developed based on the CDC protocol and has significantly increased testing – as of March 20, more than 7,200 people had tested positive statewide.
In New York City, the first batch was obtained on Feb. 7.
“The other state and local public health laboratories got test kits as they became available,” said Eric Blank, chief program officer of the Association of Public Health Laboratories.
Places in the middle of the country with no outbreaks had the luxury of time to plan. For example, Missouri officials have had about 800 tests to work with, leading to only 395 performed so far in the region by public health labs – 26 of which were positive. When private lab tests are accounted for, as of March 20 there were 47 confirmed cases.
Health care providers and public health staff in the state, however, benefited from the fact that there is less international travel to the region, according to infectious disease expert Steven Lawrence, MD, of Washington University, St. Louis.
“This is very similar to 1918 with the influenza pandemic – St. Louis had more time to prepare and was able to put measures in place to flatten the curve than, say, Philadelphia,” Dr. Lawrence said. “Seattle didn’t have an opportunity to prepare as much in advance.”
While commercial labs are coming online, strict restrictions are limiting testing capabilities, Dr. Lawrence said.
“The state has had their hands tied,” he added.
Waiting And wondering
Because of a widespread lag in testing, it is still a mystery for thousands of people to know whether they’ve come into contact with an infected person until well after it happens. As of March 20, the pandemic had killed more than 11,000 globally. More than 16,000 Americans were confirmed infected and at least 216 have died.
“CDC will distribute tests based on where they can do the most good. But without hospital-based testing and commercial testing, it will not be possible to meet the need,” said Tom Frieden, who led the CDC during President Obama’s administration and is a former commissioner of the New York City Health Department.
In California, public school teacher Claire Dugan, whose state was among the hardest hit in the initial wave of U.S. coronavirus cases, was told she didn’t qualify for testing because she had not traveled abroad to any country with an outbreak of the virus or been in contact with an infected person. Ms. Dugan, who lives in the San Francisco Bay area and is already medically fragile after a stray bullet nearly killed her while driving 4 years ago, sought a test from her doctor after registering a temperature of 100.7° F earlier this month.
“There are a lot of layers as to why this is so messed up,” said Ms. Dugan, who relies on a feeding tube and said she sought a test not only to protect herself but her students. “It’s community spreading right now, so it’s kind of silly we’re still insisting on [the early criteria for testing]. How would I know?”
Since the CDC’s initial distribution, states have been reordering more tests through the office’s International Reagent Resource – a long-standing tool that public health labs have relied on. They have also revised testing protocols to use only one sample per person, which boosts the number of people screened.
Yet problems still abound with tests or other materials needed to be able to detect the virus. California Gov. Gavin Newsom (D) said on March 12 that county public health labs can’t use all of the 8,000 test kits the state has because they are missing key components.
In Pennsylvania, state officials weren’t able to begin testing until March 2 because of problems with the CDC’s initial kit, according to Nate Wardle, a spokesperson at its department of health. New York received two newly manufactured CDC test kits on Feb. 29 and also began performing tests March 2, according to its health department.
“We are still limited on extraction kits,” Mandy Cohen, the Health & Human Services secretary in North Carolina, said in an interview in mid-March. Officials earlier this month could test only 300 patients because of shortages in the extraction materials needed to register whether the novel coronavirus is present.
In North Dakota, Loralyn Hegland wrote her physician’s practice an email on March 10 with the subject line “dry cough,” wondering if she should come in for testing after learning that was one symptom of COVID-19. The recommendation she got echoes those of countless others across the United States, saying her risk of being exposed was very low because she hadn’t traveled outside the United States and had not come into contact with a person who had been “definitely” diagnosed with the virus.
Ms. Hegland, who lives in Fargo, didn’t have a fever but decided to shelter herself, anyway, out of caution.
Would she push to get a test?
“What’s the point?” she said. “You can’t know what you don’t know. It’s just that simple. How else do you explain it to people when you’re not testing?”
KHN Midwest correspondent Lauren Weber in St. Louis contributed to this article.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
As the novel coronavirus snaked its way across the globe, the Centers for Disease Control and Prevention in early February distributed 200 test kits it had produced to more than 100 public health labs run by states and counties nationwide.
Each kit contained material to test a mere 300-400 patients. And labs, whether serving the population of New York or tiny towns in rural America, apparently received the same kits.
The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.
A woman in South Dakota with mild symptoms and no fever readily got the test and the results. Meanwhile, political leaders and public officials in places like New York, Boston, Seattle, and the San Francisco Bay area – all in the throes of serious outbreaks – couldn’t get enough tests to screen ill patients or, thereby, the information they needed to protect the general public and stem the outbreak of the virus, whose symptoms mimic those of common respiratory illnesses.
Rapid testing is crucial in the early stages of an outbreak. It allows health workers and families to identify and focus on treating those infected and isolate them.
Yet health officials in New York and such states as New York, Washington, Pennsylvania, and Georgia confirmed that they each initially got one test kit, calling into question whether they would have even stood a chance to contain the outbreaks that would emerge. They would soon discover that the tests they did receive were flawed, lacking critical components, and delivering faulty results.
During those early weeks, the virus took off, infecting thousands of people and leading to nationwide social distancing and sheltering in place. Public health officials are just beginning to grapple with the fallout from that early bungling of testing, which is likely to haunt the country in the months to come.
Too little too late
The first shipment to Washington state arrived more than 2 weeks after officials there announced the first U.S. case of coronavirus, and at a moment when deadly outbreaks of the disease were already festering in places like the Life Care Center in Kirkland. Within weeks, three dozen people infected with COVID-19 would die at the nursing home in the suburbs of Seattle.
The spread of COVID-19 would not take long to overwhelm the state, which as of March 20, 2020, had more than 1,300 cases.
The Trump administration in recent days has attempted to speed testing for the virus after early missteps hampered the government’s response to contain the contagion, and officials have had to respond to a barrage of criticism from public health experts, state officials, and members of Congress.
Federal health officials have eased the process for university and commercial labs to perform their own tests, and they are ramping up their capacity. As of March 16, public and private labs in the United States had the ability to test more than 36,000 people a day, according to estimates compiled by the American Enterprise Institute, a conservative-leaning think tank in Washington, a figure expected to rapidly escalate in coming weeks. That figure, however, can vary considerably by state and does not indicate how many tests are actually given to patients.
“We are now beginning to see that they have spread out in a prioritized way. We asked them to prioritize the regions that were mostly affected,” Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, said March 18 of private labs’ testing, without elaboration.
The scaling up of testing is set to take place after weeks of faltering and hundreds, if not thousands, of undiagnosed people spreading the virus. For example, New York’s state health department received a faulty CDC test kit on Feb. 8 for 800 patient specimens, an amount that’s consistent with other states, according to a spokesperson. It later began testing patients with a test that state officials developed based on the CDC protocol and has significantly increased testing – as of March 20, more than 7,200 people had tested positive statewide.
In New York City, the first batch was obtained on Feb. 7.
“The other state and local public health laboratories got test kits as they became available,” said Eric Blank, chief program officer of the Association of Public Health Laboratories.
Places in the middle of the country with no outbreaks had the luxury of time to plan. For example, Missouri officials have had about 800 tests to work with, leading to only 395 performed so far in the region by public health labs – 26 of which were positive. When private lab tests are accounted for, as of March 20 there were 47 confirmed cases.
Health care providers and public health staff in the state, however, benefited from the fact that there is less international travel to the region, according to infectious disease expert Steven Lawrence, MD, of Washington University, St. Louis.
“This is very similar to 1918 with the influenza pandemic – St. Louis had more time to prepare and was able to put measures in place to flatten the curve than, say, Philadelphia,” Dr. Lawrence said. “Seattle didn’t have an opportunity to prepare as much in advance.”
While commercial labs are coming online, strict restrictions are limiting testing capabilities, Dr. Lawrence said.
“The state has had their hands tied,” he added.
Waiting And wondering
Because of a widespread lag in testing, it is still a mystery for thousands of people to know whether they’ve come into contact with an infected person until well after it happens. As of March 20, the pandemic had killed more than 11,000 globally. More than 16,000 Americans were confirmed infected and at least 216 have died.
“CDC will distribute tests based on where they can do the most good. But without hospital-based testing and commercial testing, it will not be possible to meet the need,” said Tom Frieden, who led the CDC during President Obama’s administration and is a former commissioner of the New York City Health Department.
In California, public school teacher Claire Dugan, whose state was among the hardest hit in the initial wave of U.S. coronavirus cases, was told she didn’t qualify for testing because she had not traveled abroad to any country with an outbreak of the virus or been in contact with an infected person. Ms. Dugan, who lives in the San Francisco Bay area and is already medically fragile after a stray bullet nearly killed her while driving 4 years ago, sought a test from her doctor after registering a temperature of 100.7° F earlier this month.
“There are a lot of layers as to why this is so messed up,” said Ms. Dugan, who relies on a feeding tube and said she sought a test not only to protect herself but her students. “It’s community spreading right now, so it’s kind of silly we’re still insisting on [the early criteria for testing]. How would I know?”
Since the CDC’s initial distribution, states have been reordering more tests through the office’s International Reagent Resource – a long-standing tool that public health labs have relied on. They have also revised testing protocols to use only one sample per person, which boosts the number of people screened.
Yet problems still abound with tests or other materials needed to be able to detect the virus. California Gov. Gavin Newsom (D) said on March 12 that county public health labs can’t use all of the 8,000 test kits the state has because they are missing key components.
In Pennsylvania, state officials weren’t able to begin testing until March 2 because of problems with the CDC’s initial kit, according to Nate Wardle, a spokesperson at its department of health. New York received two newly manufactured CDC test kits on Feb. 29 and also began performing tests March 2, according to its health department.
“We are still limited on extraction kits,” Mandy Cohen, the Health & Human Services secretary in North Carolina, said in an interview in mid-March. Officials earlier this month could test only 300 patients because of shortages in the extraction materials needed to register whether the novel coronavirus is present.
In North Dakota, Loralyn Hegland wrote her physician’s practice an email on March 10 with the subject line “dry cough,” wondering if she should come in for testing after learning that was one symptom of COVID-19. The recommendation she got echoes those of countless others across the United States, saying her risk of being exposed was very low because she hadn’t traveled outside the United States and had not come into contact with a person who had been “definitely” diagnosed with the virus.
Ms. Hegland, who lives in Fargo, didn’t have a fever but decided to shelter herself, anyway, out of caution.
Would she push to get a test?
“What’s the point?” she said. “You can’t know what you don’t know. It’s just that simple. How else do you explain it to people when you’re not testing?”
KHN Midwest correspondent Lauren Weber in St. Louis contributed to this article.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
Sleep-disordered breathing linked with Alzheimer’s disease biomarkers in cognitively normal older adults
investigators have found.
Among 127 adults enrolled in a randomized clinical trial of interventions to promote mental well-being in older adults, those with sleep-disordered breathing had significantly greater amyloid burden and gray-matter volume, as well as increased perfusion and metabolism in parietal-occipital regions, reported Claire André, PhD, from the French Institute of Health and Medical Research (INSERM) unit in Caen, and colleagues.
“Our findings highlight the need to treat sleep disorders in the older population, even in the absence of cognitive or behavioral manifestations,” they wrote in a study published in JAMA Neurology.
Previous studies of the possible association between sleep-disordered breathing and dementia risk have shown conflicting or inconsistent results, the authors noted.
“These discrepancies may be explained by the characteristics of patients with sleep-disordered breathing (e.g., recruited from sleep clinics versus from the community, differences in age and disease duration), the scoring criteria of respiratory events, sample sizes, or the lack of controls for possibly biasing covariates,” they wrote.
To see whether they could clear up the confusion, the investigators conducted a retrospective analysis of 127 patients who were enrolled in the Age-Well randomized, controlled trial of the Medit-Ageing European project. The participants were community-dwelling adults (mean age, 69.1 years; 63% women), who were enrolled in the trial and underwent evaluation from 2016 to 2018 at the Cyceron Cancer Center in Caen.
The participants, all of whom were cognitively unimpaired at baseline, underwent neuropsychological assessment, polysomnography, MRI, plus florbetapir- and fluorodeoxyglucose-labeled PET.
The investigators defined sleep-disordered breathing as 15 apnea-hypopnea index events per hour or higher, and compared results between those with sleep-disordered breathing and those without for each imaging modality.
Participants with sleep-disordered breathing has significantly greater amyloid burden (P = .04), gray-matter volume (P = .04), perfusion (P = .04), and metabolism (P = .001), primarily overlapping the posterior cingulate cortex and precuneus, areas known to be significantly involved in Alzheimer’s disease.
When the investigators looked for behavioral and cognitive correlates of sleep-disordered breathing severity with associated brain changes, however, they found no associations with either cognitive performance, self-reported cognitive or sleep difficulties, or symptoms of daytime sleepiness.
“Importantly, to the best of our knowledge, our results show in vivo for the first time that greater amyloid burden colocalizes with greater gray-matter volume, perfusion, and metabolism in older participants with sleep-disordered breathing who are cognitively unimpaired. We believe that these overlapping patterns reinforce the likelihood of common underlying mechanisms,” they wrote.
The Age-Well randomized clinical trial is part of the Medit-Ageing project and is funded through the European Union’s Horizon 2020 Research and Innovation Program, INSERM, and Fondation d’ Entreprise MMA des Entrepreneurs du Futur. Dr. André reported no conflicts of interest to disclose.
SOURCE: André C et al. JAMA Neurol. 2020 Mar 23. doi: 10.1001/jamaneurol.2020.0311.
investigators have found.
Among 127 adults enrolled in a randomized clinical trial of interventions to promote mental well-being in older adults, those with sleep-disordered breathing had significantly greater amyloid burden and gray-matter volume, as well as increased perfusion and metabolism in parietal-occipital regions, reported Claire André, PhD, from the French Institute of Health and Medical Research (INSERM) unit in Caen, and colleagues.
“Our findings highlight the need to treat sleep disorders in the older population, even in the absence of cognitive or behavioral manifestations,” they wrote in a study published in JAMA Neurology.
Previous studies of the possible association between sleep-disordered breathing and dementia risk have shown conflicting or inconsistent results, the authors noted.
“These discrepancies may be explained by the characteristics of patients with sleep-disordered breathing (e.g., recruited from sleep clinics versus from the community, differences in age and disease duration), the scoring criteria of respiratory events, sample sizes, or the lack of controls for possibly biasing covariates,” they wrote.
To see whether they could clear up the confusion, the investigators conducted a retrospective analysis of 127 patients who were enrolled in the Age-Well randomized, controlled trial of the Medit-Ageing European project. The participants were community-dwelling adults (mean age, 69.1 years; 63% women), who were enrolled in the trial and underwent evaluation from 2016 to 2018 at the Cyceron Cancer Center in Caen.
The participants, all of whom were cognitively unimpaired at baseline, underwent neuropsychological assessment, polysomnography, MRI, plus florbetapir- and fluorodeoxyglucose-labeled PET.
The investigators defined sleep-disordered breathing as 15 apnea-hypopnea index events per hour or higher, and compared results between those with sleep-disordered breathing and those without for each imaging modality.
Participants with sleep-disordered breathing has significantly greater amyloid burden (P = .04), gray-matter volume (P = .04), perfusion (P = .04), and metabolism (P = .001), primarily overlapping the posterior cingulate cortex and precuneus, areas known to be significantly involved in Alzheimer’s disease.
When the investigators looked for behavioral and cognitive correlates of sleep-disordered breathing severity with associated brain changes, however, they found no associations with either cognitive performance, self-reported cognitive or sleep difficulties, or symptoms of daytime sleepiness.
“Importantly, to the best of our knowledge, our results show in vivo for the first time that greater amyloid burden colocalizes with greater gray-matter volume, perfusion, and metabolism in older participants with sleep-disordered breathing who are cognitively unimpaired. We believe that these overlapping patterns reinforce the likelihood of common underlying mechanisms,” they wrote.
The Age-Well randomized clinical trial is part of the Medit-Ageing project and is funded through the European Union’s Horizon 2020 Research and Innovation Program, INSERM, and Fondation d’ Entreprise MMA des Entrepreneurs du Futur. Dr. André reported no conflicts of interest to disclose.
SOURCE: André C et al. JAMA Neurol. 2020 Mar 23. doi: 10.1001/jamaneurol.2020.0311.
investigators have found.
Among 127 adults enrolled in a randomized clinical trial of interventions to promote mental well-being in older adults, those with sleep-disordered breathing had significantly greater amyloid burden and gray-matter volume, as well as increased perfusion and metabolism in parietal-occipital regions, reported Claire André, PhD, from the French Institute of Health and Medical Research (INSERM) unit in Caen, and colleagues.
“Our findings highlight the need to treat sleep disorders in the older population, even in the absence of cognitive or behavioral manifestations,” they wrote in a study published in JAMA Neurology.
Previous studies of the possible association between sleep-disordered breathing and dementia risk have shown conflicting or inconsistent results, the authors noted.
“These discrepancies may be explained by the characteristics of patients with sleep-disordered breathing (e.g., recruited from sleep clinics versus from the community, differences in age and disease duration), the scoring criteria of respiratory events, sample sizes, or the lack of controls for possibly biasing covariates,” they wrote.
To see whether they could clear up the confusion, the investigators conducted a retrospective analysis of 127 patients who were enrolled in the Age-Well randomized, controlled trial of the Medit-Ageing European project. The participants were community-dwelling adults (mean age, 69.1 years; 63% women), who were enrolled in the trial and underwent evaluation from 2016 to 2018 at the Cyceron Cancer Center in Caen.
The participants, all of whom were cognitively unimpaired at baseline, underwent neuropsychological assessment, polysomnography, MRI, plus florbetapir- and fluorodeoxyglucose-labeled PET.
The investigators defined sleep-disordered breathing as 15 apnea-hypopnea index events per hour or higher, and compared results between those with sleep-disordered breathing and those without for each imaging modality.
Participants with sleep-disordered breathing has significantly greater amyloid burden (P = .04), gray-matter volume (P = .04), perfusion (P = .04), and metabolism (P = .001), primarily overlapping the posterior cingulate cortex and precuneus, areas known to be significantly involved in Alzheimer’s disease.
When the investigators looked for behavioral and cognitive correlates of sleep-disordered breathing severity with associated brain changes, however, they found no associations with either cognitive performance, self-reported cognitive or sleep difficulties, or symptoms of daytime sleepiness.
“Importantly, to the best of our knowledge, our results show in vivo for the first time that greater amyloid burden colocalizes with greater gray-matter volume, perfusion, and metabolism in older participants with sleep-disordered breathing who are cognitively unimpaired. We believe that these overlapping patterns reinforce the likelihood of common underlying mechanisms,” they wrote.
The Age-Well randomized clinical trial is part of the Medit-Ageing project and is funded through the European Union’s Horizon 2020 Research and Innovation Program, INSERM, and Fondation d’ Entreprise MMA des Entrepreneurs du Futur. Dr. André reported no conflicts of interest to disclose.
SOURCE: André C et al. JAMA Neurol. 2020 Mar 23. doi: 10.1001/jamaneurol.2020.0311.
FROM JAMA NEUROLOGY
AMA offers resources for front-line physicians
.
The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.
“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.
The COVID-19 physician and practice resources released by the AMA include:
- A Physicians Guide to COVID-19 .
- An AMA COVID-19 online resource center and a COVID-19 FAQ.
- A Quick Guide to Telemedicine in Practice.
- Ethical guidance for physicians .
- Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
- CME for physicians through the JAMA Network’s JN Learning website.
.
The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.
“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.
The COVID-19 physician and practice resources released by the AMA include:
- A Physicians Guide to COVID-19 .
- An AMA COVID-19 online resource center and a COVID-19 FAQ.
- A Quick Guide to Telemedicine in Practice.
- Ethical guidance for physicians .
- Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
- CME for physicians through the JAMA Network’s JN Learning website.
.
The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.
“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.
The COVID-19 physician and practice resources released by the AMA include:
- A Physicians Guide to COVID-19 .
- An AMA COVID-19 online resource center and a COVID-19 FAQ.
- A Quick Guide to Telemedicine in Practice.
- Ethical guidance for physicians .
- Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
- CME for physicians through the JAMA Network’s JN Learning website.
Cancer care and COVID-19 in Seattle, the first U.S. epicenter
Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.
Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.
“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.
“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.
Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.
Create “Incident Command Structure”
In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.
Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”
Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.
First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.
“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”
Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.
“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.
“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”
Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.
In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.
Outpatient Care
Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.
To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.
One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.
Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.
Treatment Decisions
Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.
Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.
Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.
Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”
Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.
The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.
Inpatient Care
For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.
Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.
In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.
The Future
The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”
Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”
Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.
Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.
“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.
“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.
Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.
Create “Incident Command Structure”
In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.
Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”
Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.
First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.
“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”
Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.
“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.
“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”
Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.
In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.
Outpatient Care
Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.
To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.
One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.
Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.
Treatment Decisions
Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.
Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.
Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.
Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”
Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.
The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.
Inpatient Care
For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.
Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.
In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.
The Future
The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”
Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”
Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.
Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.
“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.
“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.
Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.
Create “Incident Command Structure”
In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.
Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”
Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.
First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.
“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”
Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.
“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.
“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”
Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.
In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.
Outpatient Care
Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.
To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.
One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.
Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.
Treatment Decisions
Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.
Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.
Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.
Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”
Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.
The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.
Inpatient Care
For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.
Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.
In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.
The Future
The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”
Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”
7 tips for running your practice in the coronavirus crisis
At one large practice in Bergen County, New Jersey, the waiting room is empty — but its patients are still receiving care. As of mid-March, the practice is still operating, thanks to the group’s willingness to adapt its work flow, sometimes radically, to mitigate the threat of the COVID-19 pandemic.
For example, patients now call the receptionist from their vehicles when they arrive, and wait there until receiving a call back telling them the clinician is ready. The practice has also started using telemedicine for the first time, to the extent it can be adopted in a hurry, and some clinicians are working from home on tasks such as medication refills.
Still, the rapidly increasing numbers of COVID-19 cases in the United States raises the possibility that some physician offices will decide or be forced to close temporarily, as occurred in London last month.
Many practices across the country are having to adjust the way they operate, amid daily changes in the pandemic. What should you do to adapt to this new way of operating your practice?
1. Create a task force to manage change
The readiness of medical practices to address the myriad challenges posed by this crisis has so far been a mixed bag, said Owen Dahl, MBA, a Texas-based medical practice management consultant. “Leadership is going to have to assess what’s happening in the community, what’s happening with staff members who may or may not have the disease and may or may not have to self-quarantine,” Dahl said.
The physicians, the administrator, CEO, or managing partner should be involved in decision making as the global crisis unfolds, added Laurie Morgan, MBA, a California-based practice management consultant. And depending on the size of the practice, it may be useful to delegate specific components of this work to various department managers or other individuals in the group.
The team should assess:
- Recommendations and/or mandates from local, state, and federal governments
- Guidance from specialty and state medical societies
- How to triage patients over the phone, virtual visits, or referral to an alternate site of care
- Where to send patients for testing
- The practice’s inventory of personal protective equipment (PPE)
- Review of and possible revision of current infection control policies
- Possible collaborations within the community
- Reimbursement policies for suspected COVID-19 triage, testing, and follow-up treatment — in office or virtually
- Whether some employees’ work (eg, billing, coding) can be done remotely
- Options for paying personnel in the case of a temporary shutdown
- What’s covered and excluded by the group’s business interruption insurance
2. Consider postponing nonessential appointments
What’s more, it’s crucial for practices to form a strategy that does not involve bringing patients into the office, said Javeed Siddiqui, MD, MPH, an infectious disease physician, epidemiologist, and chief medical officer of TeleMed2U. “One thing we really have to recognize in this pandemic is that we don’t want people going and sitting in our waiting room. We don’t want people coming, and not only exposing other patients, but also further exposing staff. Forward triaging is going to be essential in this type of pandemic.”
Reliant Medical Group, with multiple locations in Massachusetts, for example, announced to patients recently that it will postpone appointments for some routine and elective procedures, as determined by the group’s physicians and clinical staff.
“Taking this step will help limit the number of people passing through our facilities, which will help slow the spread of illness [as recommended by the CDC],” noted an email blast to patients.
3. Overcommunicate to patients
With a situation as dynamic and unprecedented as this, constant and clear communication with patients is crucial. “In general, in my experience, practices don’t realize how much communication is necessary,” said Morgan. “In order to be effective and get the word out, you have to be overcommunicating.”
Today’s practices have multiple ways to communicate to keep people informed, including email, text messaging, social media, patient portals, and even local television and radio.
One email or text message to the patient population can help direct them to the appropriate streams of information. Helping direct patients to updated information is critical.
In contrast, having the front desk field multitudes of calls from concerned patients ties up precious resources, according Siddiqui. “Right now, practices are absolutely inundated, patients are waiting on hold, and that creates a great deal of frustration,” he said.
“We really need to take a page from every other industry in the United States, and that is using secure SMS, email communication, and telehealth,” Siddiqui said. “Healthcare generally tends to be a laggard in this because so many people think, ‘Well, you can’t do that in healthcare,’ as opposed to thinking, ‘How can we do that in healthcare?’”
4. Take advantage of telemedicine
Fortunately, technology to interact with patients remotely is almost ubiquitous. Even for practices with little experience in this arena, various vendors exist that can get secure, HIPAA-compliant technologies up and running quickly.
Various payers have issued guidance regarding reimbursement for telemedicine specific to COVID-19, and on March 6, Congress passed a law regarding Medicare coverage and payment for virtual services during a government-declared state of emergency. Some of the rules about HIPAA compliance in telemedicine have been eased for this emergency.
But even with well-established telemedicine modalities in place, it’s crunch time for applying it to COVID-19. “You need to find a way to have telemedicine available and use it, because depending on how this goes, that’s going to be clearly the safest, best way to care for a huge number of people,” said Darryl Elmouchi, MD, MBA, chief medical officer of Spectrum Health System and president of Spectrum Health Medical Group in Michigan.
“What we recognize now, both with our past experience with telehealth for many years and specifically with this coronavirus testing we’ve done, is that it’s incredibly useful both for the clinicians and the patients,” Elmouchi said.
One possibility to consider is the tactic used by Spectrum, a large integrated healthcare system. The company mobilized its existing telemedicine program to offer free virtual screenings for anyone in Michigan showing possible symptoms of COVID-19. “We wanted to keep people out of our clinics, emergency rooms, and urgent care centers if they didn’t need to be there, and help allay fears,” he said.
Elmouchi said his company faced the problems that other physicians would also have to deal with. “It was a ton of work with a dedicated team that was focused on this. The hardest part was probably trying to determine how we can staff it,” he said.
With their dedicated virtual team still seeing regularly scheduled virtual patients, the system had to reassign its traditional teams, such as urgent care and primary care clinicians, to the virtual screening effort. “Then we had to figure out how we could operationalize it. It was a lot of work,” Elmouchi said.
Telemedicine capabilities are not limited to screening patients, but can also be used to stay in touch with patients who may be quarantined and provide follow-up care, he noted.
5. Identify COVID-19 testing sites
Access to tests remains a problem in the US, but is improving by the week. For practices that can attain the tests themselves, it will still require some creativity to administer them with as little risk as possible. In South Korea, for example, and increasingly in the United States, healthcare organizations are instructing patients waiting to be tested to stay in their cars and have a practitioner wearing the proper PPE go out to patients to test them there.
Alternatively, some practices may opt to have PPE-wearing staff members bring PPE to patients in their cars and then escort them to a designated testing area in the building —through the back door if noninfected patients are still being seen.
“Once in the office, you still need to isolate virus patients in any way you can,” Dahl said. “In fact, you want a negative-pressure environment if possible, with the air being sucked out rather than circulating,” he said, adding that a large restroom with a ventilation system could be repurposed as a makeshift exam room.
Community testing sites are another possibility, given proper coordination with other healthcare organizations and community officials. Siddiqui has been working with several communities in which individual clinics and hospitals are unable to handle testing on their own, and have instead collaborated to create community testing sites in tents on local athletic fields.
“One of our communities is looking at using the local college parking lot to do drive-through testing there,” he said. “We really need to embrace collaboration much more than we’ve ever done.”
Collaboration also requires sharing supplies and PPE, noted Dahl. “Don’t hoard them because of the shortage. Look at your inventory and make sure you can help out whomever you may be sending patients to.” And if your office is falling short, Dahl advises checking with offices in your community that may be closing — such as dentists or plastic surgeons — for supplies you can purchase or simply have.
The US Food and Drug Administration has issued some guidance to healthcare providers about shortages of surgical masks and gowns, including advice about reusable cloth alternatives to gowns.
In addition, some hospitals have asked clinicians to keep their masks and provided guidance on how to conserve supplies.
6. Preparing to potentially shut down
A temporary closure may be inevitable for some practices. “Maybe the physician owners will not feel like they have a choice,” said Morgan. “They might feel like they want to stay open for as long as they can; but if it’s not safe for patients or not safe for employees, maybe they’ll feel it’s better if they check out for a bit.”
Should practices make the decision to close or reduce hours, multimodal communication with patients and the public is paramount. Patients will want to know whom to call if they are feeling ill for any reason, where to seek care, and when the practice expects to reopen. Again, proactive outreach will be more efficient and comforting to patients.
Handling financial ramifications of closure is a top priority as well, and will require a full understanding of what is and isn’t covered by the practice’s business interruption insurance. Practices that don’t have a line of credit should reach out to banks and the Small Business Administration immediately, according to Dahl. Practices that have lines of credit already may want to ask for an increase, added Morgan.
Protecting employees’ income is challenging as well. For employees who are furloughed, consider allowing them to use their sick and vacation time during the shutdown — and possibly let staff ‘borrow’ not-yet accrued paid time off.
“However, there’s a risk with certain jobs in a medical practice that tend to have extremely high turnover, so physicians and administrators may be reluctant to pay people too much because they don’t know for sure those employees will come back to those jobs,” Morgan said. “On the other hand, if you have had a stable team for a very long time and feel confident that those employees are going to stay, then you may make a different decision.”
7. Seize work-from-home opportunities
Even if the practice isn’t seeing patients, there may be opportunities for some employees, such as billers and schedulers, to continue to work from home,” Morgan noted. Particularly if a practice is behind on its billing, a closure or slowdown is an ideal time to catch up. This measure will keep at least some people working — perhaps including some individuals who can be cross-trained to do other tasks — and maintain some cashflow when the practice needs it most.
Other remote-friendly jobs that often fall by the wayside when practices are busy include marketing tasks such as setting up or updating Google business pages, Healthgrades profiles, and so on, noted Morgan.
“Another thing that can be even more important, and is often overlooked, is making sure health plan directories have correct information about your practice,” she added. “These are pesky, often tedious tasks that may require repeated contact with health plans to fix things — perfect things to do when the office is not busy or closed.”
For administrators and billers, if the practice is able to keep paying these employees while partially or fully closed, it can also be an excellent time to do the sort of analysis that takes a lot of focused attention and is hard to do when busy. Some examples: a detailed comparison of payer performance, analysis of referral patterns, or a review of coding accuracy, Morgan suggested.
Although practices have varying levels of comfort in letting employees work from home, it’s not much different from working with external billing or scheduling services that have grown more popular in recent years, Morgan said.
As with many technologies, HIPAA is a leading concern, though it needn’t be, according to Morgan. “If you are on a cloud-based electronic medical record and practice management system, there’s a good chance that it’s very straightforward to set someone up to work from elsewhere and have that data be secure,” she said.
Finally, as the crisis begins to abate, practices must keep working in teams to evaluate and structure an orderly return to business as usual, gleaning best practices from colleagues whenever possible.
“I would tell practices this is not a time when anyone is competing with anyone,” said Elmouchi. “The more collaboration between practices and health systems that have larger resources, the better.”
This article was originally published on Medscape.com.
At one large practice in Bergen County, New Jersey, the waiting room is empty — but its patients are still receiving care. As of mid-March, the practice is still operating, thanks to the group’s willingness to adapt its work flow, sometimes radically, to mitigate the threat of the COVID-19 pandemic.
For example, patients now call the receptionist from their vehicles when they arrive, and wait there until receiving a call back telling them the clinician is ready. The practice has also started using telemedicine for the first time, to the extent it can be adopted in a hurry, and some clinicians are working from home on tasks such as medication refills.
Still, the rapidly increasing numbers of COVID-19 cases in the United States raises the possibility that some physician offices will decide or be forced to close temporarily, as occurred in London last month.
Many practices across the country are having to adjust the way they operate, amid daily changes in the pandemic. What should you do to adapt to this new way of operating your practice?
1. Create a task force to manage change
The readiness of medical practices to address the myriad challenges posed by this crisis has so far been a mixed bag, said Owen Dahl, MBA, a Texas-based medical practice management consultant. “Leadership is going to have to assess what’s happening in the community, what’s happening with staff members who may or may not have the disease and may or may not have to self-quarantine,” Dahl said.
The physicians, the administrator, CEO, or managing partner should be involved in decision making as the global crisis unfolds, added Laurie Morgan, MBA, a California-based practice management consultant. And depending on the size of the practice, it may be useful to delegate specific components of this work to various department managers or other individuals in the group.
The team should assess:
- Recommendations and/or mandates from local, state, and federal governments
- Guidance from specialty and state medical societies
- How to triage patients over the phone, virtual visits, or referral to an alternate site of care
- Where to send patients for testing
- The practice’s inventory of personal protective equipment (PPE)
- Review of and possible revision of current infection control policies
- Possible collaborations within the community
- Reimbursement policies for suspected COVID-19 triage, testing, and follow-up treatment — in office or virtually
- Whether some employees’ work (eg, billing, coding) can be done remotely
- Options for paying personnel in the case of a temporary shutdown
- What’s covered and excluded by the group’s business interruption insurance
2. Consider postponing nonessential appointments
What’s more, it’s crucial for practices to form a strategy that does not involve bringing patients into the office, said Javeed Siddiqui, MD, MPH, an infectious disease physician, epidemiologist, and chief medical officer of TeleMed2U. “One thing we really have to recognize in this pandemic is that we don’t want people going and sitting in our waiting room. We don’t want people coming, and not only exposing other patients, but also further exposing staff. Forward triaging is going to be essential in this type of pandemic.”
Reliant Medical Group, with multiple locations in Massachusetts, for example, announced to patients recently that it will postpone appointments for some routine and elective procedures, as determined by the group’s physicians and clinical staff.
“Taking this step will help limit the number of people passing through our facilities, which will help slow the spread of illness [as recommended by the CDC],” noted an email blast to patients.
3. Overcommunicate to patients
With a situation as dynamic and unprecedented as this, constant and clear communication with patients is crucial. “In general, in my experience, practices don’t realize how much communication is necessary,” said Morgan. “In order to be effective and get the word out, you have to be overcommunicating.”
Today’s practices have multiple ways to communicate to keep people informed, including email, text messaging, social media, patient portals, and even local television and radio.
One email or text message to the patient population can help direct them to the appropriate streams of information. Helping direct patients to updated information is critical.
In contrast, having the front desk field multitudes of calls from concerned patients ties up precious resources, according Siddiqui. “Right now, practices are absolutely inundated, patients are waiting on hold, and that creates a great deal of frustration,” he said.
“We really need to take a page from every other industry in the United States, and that is using secure SMS, email communication, and telehealth,” Siddiqui said. “Healthcare generally tends to be a laggard in this because so many people think, ‘Well, you can’t do that in healthcare,’ as opposed to thinking, ‘How can we do that in healthcare?’”
4. Take advantage of telemedicine
Fortunately, technology to interact with patients remotely is almost ubiquitous. Even for practices with little experience in this arena, various vendors exist that can get secure, HIPAA-compliant technologies up and running quickly.
Various payers have issued guidance regarding reimbursement for telemedicine specific to COVID-19, and on March 6, Congress passed a law regarding Medicare coverage and payment for virtual services during a government-declared state of emergency. Some of the rules about HIPAA compliance in telemedicine have been eased for this emergency.
But even with well-established telemedicine modalities in place, it’s crunch time for applying it to COVID-19. “You need to find a way to have telemedicine available and use it, because depending on how this goes, that’s going to be clearly the safest, best way to care for a huge number of people,” said Darryl Elmouchi, MD, MBA, chief medical officer of Spectrum Health System and president of Spectrum Health Medical Group in Michigan.
“What we recognize now, both with our past experience with telehealth for many years and specifically with this coronavirus testing we’ve done, is that it’s incredibly useful both for the clinicians and the patients,” Elmouchi said.
One possibility to consider is the tactic used by Spectrum, a large integrated healthcare system. The company mobilized its existing telemedicine program to offer free virtual screenings for anyone in Michigan showing possible symptoms of COVID-19. “We wanted to keep people out of our clinics, emergency rooms, and urgent care centers if they didn’t need to be there, and help allay fears,” he said.
Elmouchi said his company faced the problems that other physicians would also have to deal with. “It was a ton of work with a dedicated team that was focused on this. The hardest part was probably trying to determine how we can staff it,” he said.
With their dedicated virtual team still seeing regularly scheduled virtual patients, the system had to reassign its traditional teams, such as urgent care and primary care clinicians, to the virtual screening effort. “Then we had to figure out how we could operationalize it. It was a lot of work,” Elmouchi said.
Telemedicine capabilities are not limited to screening patients, but can also be used to stay in touch with patients who may be quarantined and provide follow-up care, he noted.
5. Identify COVID-19 testing sites
Access to tests remains a problem in the US, but is improving by the week. For practices that can attain the tests themselves, it will still require some creativity to administer them with as little risk as possible. In South Korea, for example, and increasingly in the United States, healthcare organizations are instructing patients waiting to be tested to stay in their cars and have a practitioner wearing the proper PPE go out to patients to test them there.
Alternatively, some practices may opt to have PPE-wearing staff members bring PPE to patients in their cars and then escort them to a designated testing area in the building —through the back door if noninfected patients are still being seen.
“Once in the office, you still need to isolate virus patients in any way you can,” Dahl said. “In fact, you want a negative-pressure environment if possible, with the air being sucked out rather than circulating,” he said, adding that a large restroom with a ventilation system could be repurposed as a makeshift exam room.
Community testing sites are another possibility, given proper coordination with other healthcare organizations and community officials. Siddiqui has been working with several communities in which individual clinics and hospitals are unable to handle testing on their own, and have instead collaborated to create community testing sites in tents on local athletic fields.
“One of our communities is looking at using the local college parking lot to do drive-through testing there,” he said. “We really need to embrace collaboration much more than we’ve ever done.”
Collaboration also requires sharing supplies and PPE, noted Dahl. “Don’t hoard them because of the shortage. Look at your inventory and make sure you can help out whomever you may be sending patients to.” And if your office is falling short, Dahl advises checking with offices in your community that may be closing — such as dentists or plastic surgeons — for supplies you can purchase or simply have.
The US Food and Drug Administration has issued some guidance to healthcare providers about shortages of surgical masks and gowns, including advice about reusable cloth alternatives to gowns.
In addition, some hospitals have asked clinicians to keep their masks and provided guidance on how to conserve supplies.
6. Preparing to potentially shut down
A temporary closure may be inevitable for some practices. “Maybe the physician owners will not feel like they have a choice,” said Morgan. “They might feel like they want to stay open for as long as they can; but if it’s not safe for patients or not safe for employees, maybe they’ll feel it’s better if they check out for a bit.”
Should practices make the decision to close or reduce hours, multimodal communication with patients and the public is paramount. Patients will want to know whom to call if they are feeling ill for any reason, where to seek care, and when the practice expects to reopen. Again, proactive outreach will be more efficient and comforting to patients.
Handling financial ramifications of closure is a top priority as well, and will require a full understanding of what is and isn’t covered by the practice’s business interruption insurance. Practices that don’t have a line of credit should reach out to banks and the Small Business Administration immediately, according to Dahl. Practices that have lines of credit already may want to ask for an increase, added Morgan.
Protecting employees’ income is challenging as well. For employees who are furloughed, consider allowing them to use their sick and vacation time during the shutdown — and possibly let staff ‘borrow’ not-yet accrued paid time off.
“However, there’s a risk with certain jobs in a medical practice that tend to have extremely high turnover, so physicians and administrators may be reluctant to pay people too much because they don’t know for sure those employees will come back to those jobs,” Morgan said. “On the other hand, if you have had a stable team for a very long time and feel confident that those employees are going to stay, then you may make a different decision.”
7. Seize work-from-home opportunities
Even if the practice isn’t seeing patients, there may be opportunities for some employees, such as billers and schedulers, to continue to work from home,” Morgan noted. Particularly if a practice is behind on its billing, a closure or slowdown is an ideal time to catch up. This measure will keep at least some people working — perhaps including some individuals who can be cross-trained to do other tasks — and maintain some cashflow when the practice needs it most.
Other remote-friendly jobs that often fall by the wayside when practices are busy include marketing tasks such as setting up or updating Google business pages, Healthgrades profiles, and so on, noted Morgan.
“Another thing that can be even more important, and is often overlooked, is making sure health plan directories have correct information about your practice,” she added. “These are pesky, often tedious tasks that may require repeated contact with health plans to fix things — perfect things to do when the office is not busy or closed.”
For administrators and billers, if the practice is able to keep paying these employees while partially or fully closed, it can also be an excellent time to do the sort of analysis that takes a lot of focused attention and is hard to do when busy. Some examples: a detailed comparison of payer performance, analysis of referral patterns, or a review of coding accuracy, Morgan suggested.
Although practices have varying levels of comfort in letting employees work from home, it’s not much different from working with external billing or scheduling services that have grown more popular in recent years, Morgan said.
As with many technologies, HIPAA is a leading concern, though it needn’t be, according to Morgan. “If you are on a cloud-based electronic medical record and practice management system, there’s a good chance that it’s very straightforward to set someone up to work from elsewhere and have that data be secure,” she said.
Finally, as the crisis begins to abate, practices must keep working in teams to evaluate and structure an orderly return to business as usual, gleaning best practices from colleagues whenever possible.
“I would tell practices this is not a time when anyone is competing with anyone,” said Elmouchi. “The more collaboration between practices and health systems that have larger resources, the better.”
This article was originally published on Medscape.com.
At one large practice in Bergen County, New Jersey, the waiting room is empty — but its patients are still receiving care. As of mid-March, the practice is still operating, thanks to the group’s willingness to adapt its work flow, sometimes radically, to mitigate the threat of the COVID-19 pandemic.
For example, patients now call the receptionist from their vehicles when they arrive, and wait there until receiving a call back telling them the clinician is ready. The practice has also started using telemedicine for the first time, to the extent it can be adopted in a hurry, and some clinicians are working from home on tasks such as medication refills.
Still, the rapidly increasing numbers of COVID-19 cases in the United States raises the possibility that some physician offices will decide or be forced to close temporarily, as occurred in London last month.
Many practices across the country are having to adjust the way they operate, amid daily changes in the pandemic. What should you do to adapt to this new way of operating your practice?
1. Create a task force to manage change
The readiness of medical practices to address the myriad challenges posed by this crisis has so far been a mixed bag, said Owen Dahl, MBA, a Texas-based medical practice management consultant. “Leadership is going to have to assess what’s happening in the community, what’s happening with staff members who may or may not have the disease and may or may not have to self-quarantine,” Dahl said.
The physicians, the administrator, CEO, or managing partner should be involved in decision making as the global crisis unfolds, added Laurie Morgan, MBA, a California-based practice management consultant. And depending on the size of the practice, it may be useful to delegate specific components of this work to various department managers or other individuals in the group.
The team should assess:
- Recommendations and/or mandates from local, state, and federal governments
- Guidance from specialty and state medical societies
- How to triage patients over the phone, virtual visits, or referral to an alternate site of care
- Where to send patients for testing
- The practice’s inventory of personal protective equipment (PPE)
- Review of and possible revision of current infection control policies
- Possible collaborations within the community
- Reimbursement policies for suspected COVID-19 triage, testing, and follow-up treatment — in office or virtually
- Whether some employees’ work (eg, billing, coding) can be done remotely
- Options for paying personnel in the case of a temporary shutdown
- What’s covered and excluded by the group’s business interruption insurance
2. Consider postponing nonessential appointments
What’s more, it’s crucial for practices to form a strategy that does not involve bringing patients into the office, said Javeed Siddiqui, MD, MPH, an infectious disease physician, epidemiologist, and chief medical officer of TeleMed2U. “One thing we really have to recognize in this pandemic is that we don’t want people going and sitting in our waiting room. We don’t want people coming, and not only exposing other patients, but also further exposing staff. Forward triaging is going to be essential in this type of pandemic.”
Reliant Medical Group, with multiple locations in Massachusetts, for example, announced to patients recently that it will postpone appointments for some routine and elective procedures, as determined by the group’s physicians and clinical staff.
“Taking this step will help limit the number of people passing through our facilities, which will help slow the spread of illness [as recommended by the CDC],” noted an email blast to patients.
3. Overcommunicate to patients
With a situation as dynamic and unprecedented as this, constant and clear communication with patients is crucial. “In general, in my experience, practices don’t realize how much communication is necessary,” said Morgan. “In order to be effective and get the word out, you have to be overcommunicating.”
Today’s practices have multiple ways to communicate to keep people informed, including email, text messaging, social media, patient portals, and even local television and radio.
One email or text message to the patient population can help direct them to the appropriate streams of information. Helping direct patients to updated information is critical.
In contrast, having the front desk field multitudes of calls from concerned patients ties up precious resources, according Siddiqui. “Right now, practices are absolutely inundated, patients are waiting on hold, and that creates a great deal of frustration,” he said.
“We really need to take a page from every other industry in the United States, and that is using secure SMS, email communication, and telehealth,” Siddiqui said. “Healthcare generally tends to be a laggard in this because so many people think, ‘Well, you can’t do that in healthcare,’ as opposed to thinking, ‘How can we do that in healthcare?’”
4. Take advantage of telemedicine
Fortunately, technology to interact with patients remotely is almost ubiquitous. Even for practices with little experience in this arena, various vendors exist that can get secure, HIPAA-compliant technologies up and running quickly.
Various payers have issued guidance regarding reimbursement for telemedicine specific to COVID-19, and on March 6, Congress passed a law regarding Medicare coverage and payment for virtual services during a government-declared state of emergency. Some of the rules about HIPAA compliance in telemedicine have been eased for this emergency.
But even with well-established telemedicine modalities in place, it’s crunch time for applying it to COVID-19. “You need to find a way to have telemedicine available and use it, because depending on how this goes, that’s going to be clearly the safest, best way to care for a huge number of people,” said Darryl Elmouchi, MD, MBA, chief medical officer of Spectrum Health System and president of Spectrum Health Medical Group in Michigan.
“What we recognize now, both with our past experience with telehealth for many years and specifically with this coronavirus testing we’ve done, is that it’s incredibly useful both for the clinicians and the patients,” Elmouchi said.
One possibility to consider is the tactic used by Spectrum, a large integrated healthcare system. The company mobilized its existing telemedicine program to offer free virtual screenings for anyone in Michigan showing possible symptoms of COVID-19. “We wanted to keep people out of our clinics, emergency rooms, and urgent care centers if they didn’t need to be there, and help allay fears,” he said.
Elmouchi said his company faced the problems that other physicians would also have to deal with. “It was a ton of work with a dedicated team that was focused on this. The hardest part was probably trying to determine how we can staff it,” he said.
With their dedicated virtual team still seeing regularly scheduled virtual patients, the system had to reassign its traditional teams, such as urgent care and primary care clinicians, to the virtual screening effort. “Then we had to figure out how we could operationalize it. It was a lot of work,” Elmouchi said.
Telemedicine capabilities are not limited to screening patients, but can also be used to stay in touch with patients who may be quarantined and provide follow-up care, he noted.
5. Identify COVID-19 testing sites
Access to tests remains a problem in the US, but is improving by the week. For practices that can attain the tests themselves, it will still require some creativity to administer them with as little risk as possible. In South Korea, for example, and increasingly in the United States, healthcare organizations are instructing patients waiting to be tested to stay in their cars and have a practitioner wearing the proper PPE go out to patients to test them there.
Alternatively, some practices may opt to have PPE-wearing staff members bring PPE to patients in their cars and then escort them to a designated testing area in the building —through the back door if noninfected patients are still being seen.
“Once in the office, you still need to isolate virus patients in any way you can,” Dahl said. “In fact, you want a negative-pressure environment if possible, with the air being sucked out rather than circulating,” he said, adding that a large restroom with a ventilation system could be repurposed as a makeshift exam room.
Community testing sites are another possibility, given proper coordination with other healthcare organizations and community officials. Siddiqui has been working with several communities in which individual clinics and hospitals are unable to handle testing on their own, and have instead collaborated to create community testing sites in tents on local athletic fields.
“One of our communities is looking at using the local college parking lot to do drive-through testing there,” he said. “We really need to embrace collaboration much more than we’ve ever done.”
Collaboration also requires sharing supplies and PPE, noted Dahl. “Don’t hoard them because of the shortage. Look at your inventory and make sure you can help out whomever you may be sending patients to.” And if your office is falling short, Dahl advises checking with offices in your community that may be closing — such as dentists or plastic surgeons — for supplies you can purchase or simply have.
The US Food and Drug Administration has issued some guidance to healthcare providers about shortages of surgical masks and gowns, including advice about reusable cloth alternatives to gowns.
In addition, some hospitals have asked clinicians to keep their masks and provided guidance on how to conserve supplies.
6. Preparing to potentially shut down
A temporary closure may be inevitable for some practices. “Maybe the physician owners will not feel like they have a choice,” said Morgan. “They might feel like they want to stay open for as long as they can; but if it’s not safe for patients or not safe for employees, maybe they’ll feel it’s better if they check out for a bit.”
Should practices make the decision to close or reduce hours, multimodal communication with patients and the public is paramount. Patients will want to know whom to call if they are feeling ill for any reason, where to seek care, and when the practice expects to reopen. Again, proactive outreach will be more efficient and comforting to patients.
Handling financial ramifications of closure is a top priority as well, and will require a full understanding of what is and isn’t covered by the practice’s business interruption insurance. Practices that don’t have a line of credit should reach out to banks and the Small Business Administration immediately, according to Dahl. Practices that have lines of credit already may want to ask for an increase, added Morgan.
Protecting employees’ income is challenging as well. For employees who are furloughed, consider allowing them to use their sick and vacation time during the shutdown — and possibly let staff ‘borrow’ not-yet accrued paid time off.
“However, there’s a risk with certain jobs in a medical practice that tend to have extremely high turnover, so physicians and administrators may be reluctant to pay people too much because they don’t know for sure those employees will come back to those jobs,” Morgan said. “On the other hand, if you have had a stable team for a very long time and feel confident that those employees are going to stay, then you may make a different decision.”
7. Seize work-from-home opportunities
Even if the practice isn’t seeing patients, there may be opportunities for some employees, such as billers and schedulers, to continue to work from home,” Morgan noted. Particularly if a practice is behind on its billing, a closure or slowdown is an ideal time to catch up. This measure will keep at least some people working — perhaps including some individuals who can be cross-trained to do other tasks — and maintain some cashflow when the practice needs it most.
Other remote-friendly jobs that often fall by the wayside when practices are busy include marketing tasks such as setting up or updating Google business pages, Healthgrades profiles, and so on, noted Morgan.
“Another thing that can be even more important, and is often overlooked, is making sure health plan directories have correct information about your practice,” she added. “These are pesky, often tedious tasks that may require repeated contact with health plans to fix things — perfect things to do when the office is not busy or closed.”
For administrators and billers, if the practice is able to keep paying these employees while partially or fully closed, it can also be an excellent time to do the sort of analysis that takes a lot of focused attention and is hard to do when busy. Some examples: a detailed comparison of payer performance, analysis of referral patterns, or a review of coding accuracy, Morgan suggested.
Although practices have varying levels of comfort in letting employees work from home, it’s not much different from working with external billing or scheduling services that have grown more popular in recent years, Morgan said.
As with many technologies, HIPAA is a leading concern, though it needn’t be, according to Morgan. “If you are on a cloud-based electronic medical record and practice management system, there’s a good chance that it’s very straightforward to set someone up to work from elsewhere and have that data be secure,” she said.
Finally, as the crisis begins to abate, practices must keep working in teams to evaluate and structure an orderly return to business as usual, gleaning best practices from colleagues whenever possible.
“I would tell practices this is not a time when anyone is competing with anyone,” said Elmouchi. “The more collaboration between practices and health systems that have larger resources, the better.”
This article was originally published on Medscape.com.