4/23/20 Clinician Office COVID Guideline

(Optional items italicized)

Effective Date:  In place on re-opening or expanding clinical services
Duration: Until public health emergency lifted
Version 1.0 Date:  April 23, 2020


Disclaimer:  There are little or no controlled studies underlying these recommendations.  They are based on CDC recommendations, local health department orders, and expert consensus of PHC medical directors.  They should be considered a starting point for evaluation of office systems, and may be modified by the clinical leadership at a practice.  Any directive by a local health officer which is more stringent than these guidelines would take precedence.

Send comments or suggestions for improvements to: rmoore@partnershiphp.org

Patient Care in Office:
  1. Staff and clinicians will wear face masks at all times, as will patients. This should be explained to patients before they arrive at the office.
  2. Patients without their own masks will be given one on entry to the office. The mask should completely cover over the nose to below the chin and fit snugly along the sides.
  3. Staff and clinicians will wear gloves for any patient contact, disposing gloves between patients and washing hands before entering and upon leaving each exam room.
  4. Stethoscopes, blood pressure cuffs and other non-disposable equipment touching patients should be cleansed before and after each use.
  5. When rapid, point of care PCR tests become available for office use, perform a rapid test on asymptomatic individuals prior to performing procedure that will generate significant aerosol (e.g. dental extractions, dental cleanings, office spirometry)
Virtual Visits: (all patients should be contacted by phone before coming to the office)
  1. Patients with contact with a person who tested positive for COVID 19 or who are experiencing fever, chest congestion, flu-like symptoms or symptoms of milder respiratory infection will be asked not to visit the office but rather to consult with the physician via phone or video conferencing.
  2. Patients who are immunosuppressed or are at higher risk for COVID 19 related complications, will be offered phone or video conferencing. If they must be seen, have a plan that minimizes their risk, such as seeing them in the first few hours of the day, or conducting a detailed history over video/phone first, before a brief office visit.
  3. Develop workflows and best practices for visits to be addressed by video/phone as much as possible.  Use these guidelines to limit exposure of patients and staff to potential  infection when in person visits are needed for routine visits ( well child, women’s physicals for example) and as indicated for face to face visits for chronic disease management or other necessary exams. Consider:

a. If a person is coming in for a face to face visit for one reason, ensure all            related reasons for a face to face visit are done at the same time.

b. Methods of optimizing obtaining history and doing a partial physical exam          by virtual visit to make the physical visit short and efficient with minimum          chance of infection transmission.

c. Finding alternatives to more hazardous examinations/procedures, such as       coaching parents on application of fluoride varnish over phone or                       application of silver diamine fluoride to caries instead of tooth extraction or       filling. 

4If patients with symptoms listed below need to be seen in the office, they will be      scheduled at a time and in a manner to prevent potential infection of other                patients. This may include

a. Examining the patient in their car.

b. If the patient may not be examined in their car, they would be scheduled at        a time and location where other patients would not be using the same room      until decontamination is possible.

c. Moving them directly to an examining room with no waiting room time               (potentially through an alternative entrance), followed by thorough                     decontamination/aeration of the exam room.

 Operational Aspects:
5. Patients will be scheduled in such a manner to maintain six foot spacing in the
            waiting area.  This may require patients to wait in their cars until called in to the
            office, or moving the patient directly to an examination room from the waiting
            room upon arrival.
6. Patients should be seen in the office alone unless they need a caregiver, or they
    are a minor needing an adult.


Staffing Aspects: 
1. Temperatures and symptom review (see below) of staff will be done each day.
2. Any staff member with symptoms potentially caused by SARS-CoV2 will be
    referred for testing as a healthcare worker with face-to-face patient contact.
3. Staff members with exposure to a person who tested positive for the virus will be
    asked to remain home under paid sick leave for 14 days, only returning after
    consultation with clinician in charge. In circumstances of significant staff 
    shortage, if rapid PCR testing is widely available, an asymptomatic exposed 
    staff member who tests negative for coronavirus may be considered for return
    to work with continuous mask use for a day or two (they would need to be
    retested every couple days to be sure they do not develop viral shedding).
4. If scribes are used by a practice, consider changes to support infection control.        Examples may include having them support virtual visits or virtual pre-visits              where the history is gathered.


Maintenance and Facilities: 
1. Hand sanitizers as well as soap and hot water for hand-washing are readily
    available throughout the office and waiting areas.
2. Cross contamination will be minimized by frequent sanitizing (wiping down) of
    surfaces, doorknobs, light handles, keyboards, phones, etc. with isopropyl
    alcohol or chlorine-based cleansers.
3. Scrubs and lab coats should be laundered daily. Neckties or other loose clothing
    that could contact patients should be avoided.
4. In the setting of an office where patients may walk in for care without a mask or
    where no screening for respiratory infections before visits can be done, adding a
    Plexiglas barrier for reception staff may need to be added.
5. Any break room should be arranged and use scheduled to allow at least 6 feet of
    distance between individuals who are eating and drinking. Discourage
    conversation while eating.
6. Shared restrooms should have surfaces decontaminated with increased
    frequency, depending on how much it is used.
7. Review decontamination procedures done by maintenance staff to ensure they
    are conducting duties in a way that protects them and thoroughly
    decontaminates the office.
8. Develop a procedure for educating staff on these infection transmission
    prevention measures and monitoring their adherence.


Symptom Review:
  • Fever
  • Cough
  • Sore throat
  • Shortness of breath
  • Chills
  • Severe fatigue
  • Unusual headache
  • Runny nose in the absence of known allergies
  • Gastro-intestinal symptoms such as diarrhea or stomach cramps
  • Loss of sense of smell (anosmia) or taste or suddenly all food tastes bad (dysgeusia)

Temperature Guidelines:

 Temperature of 100 degrees F or greater or with any symptoms above should be            isolated.

Definition of Higher Risk for Serious COVID infection  (CDC guidelines)

  • Age over 65
  • Residents of congregate living facility (skilled nursing facility, homeless shelter)
  • Chronic Lung Disease, including COPD
  • Chronic Lung Disease, including CHF
  • Kidney failure of advanced kidney disease
  • Cirrhosis or other chronic liver disease
  • Diabetes
  • Other condition impairing immune system
  • Taking medication impairing immune system (includes most on current cancer treatment)
  • Severe obesity (BMI over 40)

Definition of Exposure requiring Quarantine (recommendations vary; CDC guidelines complex)

  • Direct contact with person known to be infected with COVID
  • Less than 6 feet distance for at least 5 minutes with a person known to be infected with COVID who was coughing (regardless of wearing of a mask) or who was not coughing but not wearing a facial covering.
  • Living in same dwelling as a person with COVID, regardless of mask use
  • Recent travel from area more highly impacted by COVID than “home” area, especially if by crowded public transportation.

4/23/20 Safely Increasing Outpatient Health Care

Safely Increasing Outpatient Health Care:  Yesterday, Governor Newsom recommended a resumption of some types of outpatient medical visits, with appropriate precautions to prevent spread of infection.  We know you are working on fine-tuning quality and efficiency of your virtual visits, while working to ensure your offices are safe for visits that need to occur in person.  The CMA released a high level summary on reopening physician practices.  The PHC Medical Director team gathered together a number of best practices for re-opening clinician practices of all types.  Clinician Office COVID Guideline is posted separately in this blog.  It includes operational, staff, patient flow, and facilities recommendations.  We hope it will be a useful check list clinical and operational leaders working to make their offices safe for employees and patients.  Some useful additional advice for optimizing video visits can be found in this NEJM article.

Here is a weekly curation of COVID updates that we thought would be of interest to primary care clinicians, with a special focus on many less-recognized clinical manifestations.  We appreciate leads on topics for future updates, as well as comments and feedback!

  1. PHC Policy Updates Related to COVID
    1. Home Blood Pressure Test Kits:  Virtual care of patients with hypertension includes the ability for the patient to check their blood pressure at home.  Blood Pressure Test Kits are PHC benefit, provided with a prescription by community pharmacies (not DME vendors).  The prescription can specify the size of the cuff that is in the kit (Medium and Large are the two most common), and should include the diagnosis of “hypertension” on the prescription.  You may work with your local pharmacy to see what brands are available and write the prescription for that brand.  Currently, any BP cuff costing under $55 is covered (this limit is likely to increase soon).  Pharmacies that have questions can consult the PHC website for information; please let us know if they refuse to honor a prescription for a BP cuff, and we can reach out to educate them.  More information about coverage of Ambulatory BP monitors and BP monitors that automatically send results to the PCP will be presented in a future update.
    2. Virtual visits by Physical Therapy, Speech Therapy, Occupational TherapyPHC has activated special codes normally used by MediCare for coverage of video visits by PT/ST/OT to provide education and observation of patients who do not need an in-person visit.  We have educated our therapy network of these changes.  Patients needing PT/OT/ST services need a prescription from a referring clinician (no need to use the PHC RAF system).
  1. Role of Serology Testing in Managing COVID. While PCR/RNA/molecular testing is steadily becoming more available, unapproved serology/antibody tests are making their way into the market in a somewhat chaotic fashion.  Jill Taylor of the N.Y. State Department of Health stated in an excellent National Academy of Science presentation yesterday that over 125 new serology/antibody tests (many of questionable accuracy) are now available in the United States, although only 5 had official FDA recognition for emergency use.  She states that many rapid serology tests will detect milder coronaviruses that cause cold-like symptoms (low specificity), causing rapid surveillance studies to suggest higher rates of immunity than actually exists.  Furthermore, we cannot equate presence of an antibody response to true immunity to re-infection.  These factors make antibody testing currently unhelpful for counseling individual patients about immunity or safety to return to work.  This may change in the near future.

  Seroprevalence studies done in early April in Los Angeles and Santa Clara are        good examples.  Both estimate that about 4% of adults have antibodies in their        blood, about 50-fold greater than the number of confirmed positive COVID tests.      While some cross-reactivity with milder coronaviruses may be inflating the                number, the bottom line is that the vast majority of the population is still                    susceptible to SARS-CoV2, even in these two counties with California’s heaviest      COVID-19 toll.  Current estimates are that 60-70% herd immunity would be              needed for COVID infection rates to fall.

  1. How much PCR testing capacity do we need?  The current testing rate in the United States is about 0.4-0.5 PCR tests per 1000 population per day.  Dr. Ashish Jha of the Harvard Global Health Institute estimated that about 1.5 to 2.5 PCR tests per 1000 population per day will be needed to provide the robust testing of all symptomatic individuals, their asymptomatic contacts, and certain asymptomatic essential workers to safely allow significant resumption of economic activity.  For the PHC counties, this would be a total of about 4000-6000 tests per day.  This is possible with the current spectrum of tests available, and far more achievable than the 60-100 PCR tests per 1000 population per day recommended by the Roadmap to Pandemic Resilience report released on April 20.
  1. Additional study on N95 decontamination suggests less repeat decontamination cycles than studies previously reviewed in this newsletter.  This study looked at the ability of N95 masks to filter SARS-CoV2 and evaluated integrity using post-sterilization fit testing.  This suggested that dry heat sterilization can only be done twice before the N95 fails a fit test.  Of note, this study was not yet peer reviewed and comments posted pointed out some important methodological concerns.
  1. Communication aid for having difficult conversations about COVID.  VitalTalks Tips is a free smart phone app that help with difficult conversations with patients, with several sections devoted to COVID-related situations.  I recommend loading it on your smart phone and taking a few minutes to scan through some of the questions/topics that are included.
  1. Therapeutic updates:
    1. A well-publicized Randomized control trial of hydroxychloroquine showed increased mortality.
    2. Trial of remdesivir in macaque monkey model:  (summary from UCSF ID newsletter)  Researchers developed a macaque model of respiratory SARS-CoV-2 infection that recapitulates important aspects of human infections. Investigators from the NIH studiedthe effect of remdesivir treatment starting near the peak of viral replication. Remdesivir was administered with a loading dose 12 hours after respiratory and ocular inoculation, followed by a daily IV dose for 6 days, similar to protocols for humans.  At 12 hours after the initial treatment, the remdesivir-treated monkeys had fewer symptoms and less radiologic evidence of pneumonia compared to the control-treated monkeys, a trend which continued during the 7-day study. The remdesivir-treated monkeys had lower viral loads and titers of infectious virus in the lungs and less damage, but interestingly, drug treatment did not decrease viral shedding in the nose, throat, or rectal swabs. While the Gilead remdesivir clinical trial results are not yet known, this primate model suggests that early treatment of COVID-19 with remdesivir may prevent progression to severe pneumonia and sterilize viral cultures in the upper and lower airways. Upper airway viral shedding was still detectable; however, the significance of PCR detectable virus in the absence of viral growth is not known.
    3. ACEI/ARB not just safe, but also protective:  Early data from China indicating that hypertension was a risk factor for COVID severity, combined with the fact that the ACE2 receptor in the lung led to speculation that use of ACEI or ARB increased risk of COVID complications.  However, a new report from China showed actually that ACE  or ARB use among hospitalized patients with COVID was associated with increased survival.

7. Clinical Updates: As time passes, more reports are showing the wide spectrum        of signs and symptoms associated with COVID.  Some of these are contrary to        the early information we had about the disease, so they are important to                  incorporate into our clinical decision making, so we don’t reassure patients              infected with SARS-CoV2 that they have something else, leading to spread of          infection (something we are concerned is occurring, due to the shortage of              tests).

A. Co-infection rate with other respiratory pathogens. A study in Northern              California published in JAMA found that 20% of those diagnosed with                COVID were co-infected with another respiratory pathogen.  Based on this,      individuals with symptoms potentially due to COVID should be tested for          COVID, even if another test, such as rapid influenza or RSV tests, are              positive.                                                                                                    BSmell and taste disturbance in COVID. A physician in Italy noted (in                  the setting of the epidemic) that sudden anosmia or dysgeusia with                    nausea –even without other respiratory symptoms—was universally                  found to be associated with a positive PCR test for COVID.   A recent                JAMA study of patients with these abnormalities found that most                        (97%) eventually develop other symptoms of COVID (including even                  nasal congestion in 35%), but that 12% noted anosmia or dysgeusia as            their first symptom.  A case report of one such patient found mucous                  obstruction just below the olfactory nerve, but no imaging abnormality of the      olfactory nerve itself, suggesting the etiology may be  obstructive, but not          ruling out direct infection of the olfactory nerve.                                                 C. Why are COVID patients dying at home? The report yesterday that                   two individuals in Santa Clara who died in early February were found                 to be infected with COVID is not only interesting for the historical                        epidemiologic implications, but also as an indicator of an important                   scary clinical scenario: hypoxia without dyspnea.  NY times                         article (highly recommended reading) noted that these individuals                     have pneumonia with decreased oxygen levels but with a normal CO2.             They compensate with a more rapid respiratory rate but don’t feel the               dyspnea until the pneumonia worsens with elevated CO2, at which                   time they decompensate quickly, potentially dying at home or requiring             intubation by EMS.  The article gives anecdotes of the use of oxygen                 saturation monitors by patients sent home with pneumonia to monitor               for detecting hypoxia earlier.  PHC is looking into options for making                 oxygen saturation monitors available to our members.  There is a                       world-wide shortage of these devices currently.                                       D. CT scans identify asymptomatic COVID in New                                                   York.  Another report from an Emergency Room Physician in New                     York found that a number of asymptomatic individuals or minimally                     symptomatic individuals who came to the ED for other reasons were                 found on CT to have COVID pneumonia.  This included a patient with               abdominal pain, nausea and vomiting and another with symptoms of                 acute coronary syndrome.                                                                                  E. Are there cutaneous manifestations of COVID-19?:  (summary                          from UCSF ID newsletter)                                                                                    Cutaneous findings were rarely reported (<1%) inlarge studies from                  China.  A recent study from Italy found that 18 of 88 (20%)                                  hospitalized patients had skin findings: erythematous rash (78%),                      diffuse urticaria (17%), and vesicles resembling varicella (5%)                            Another report from Italy described 22 patients with                                            papulovesicular eruption resembling varicella. In both reports, the                      trunk was most commonly involved, and itching was uncommon.                        Individual case reports of patients with COVID-19 and a diffuse                          erythematous rashdiffuse urticariapetechial rash,                                            and violaceous lesions in the toes have been described as well                          (sometimes called “COVID toes”), as shown below.                                            Photo: Northwestern University

Northwestern University

       The American Academy of Dermatology has launched a COVID-19                   dermatology registry to better understand the cutaneous manifestations             of COVID-19.                                                                                                    F. Neurologic manifestations of COVID: (summary from UCSF ID                           newsletter)  What neurological manifestations are seen in patients with              COVID-19? Several reports were published this week on neurological                findings in patients with COVID-19. A Chinese study described 214                    patients and found that 36.4% had neurologic manifestations which                  included dizziness (16.8%), headache (13.1%), myopathy (10.7%),                    impaired consciousness (7.5%), taste impairment (5.6%), smell                          impairment (5.1%), acute stroke (2.8%), and seizure (0.5%). A second              French study of 58 ICU patients found agitation (69%), corticospinal                  tract signs such as clonus (67%), and confusion (65%). 13 patients                    had MRIs which revealed leptomeningeal enhancement in 62% and                  acute stroke in 15%. 7 patients had an LP – all were normal and                        negative for COVID-19 by PCR. Conclusion: Neurologic finding are                    common in patients with severe COVID-19. Possible mechanisms                    include hypercoagulability, inflammation, exacerbation of underlying                  vascular comorbidities, or direct CNS infection. However, only a single              case of meningoencephalitis with a positive CSF PCR has been                        published to date.                                                                                            G. Ocular manifestations of COVID-19: (summary from UCSF ID                            newsletter)  The main ocular manifestation of COVID-19 is                                conjunctivitis. A recent report described the ocular findings in a cohort                of 38 patients from China: 12 patients (38%) had chemosis,                                conjunctival hyperemia, and epiphora (watery eyes). All 12 patients                    had moderate, severe, or critical illness, suggesting that ocular                          findings may be found in more severe disease. Notably, one patient                  had epiphora (“watery eyes”) as the first symptom of COVID-19. Two                out of the 12 patients had a positive conjunctival swab for COVID-19,                suggesting the possibility of transmission directly from the eye. Prior to              this report, there were also a few case reports where conjunctivitis                    was described as part of the clinical syndrome of COVID-19.                        H. Is COVID death sometimes due to multiple blood clots to lungs?                         (summary from UCSF ID newsletter)  Are patients with COVID-19                     hypercoagulable and would they benefit from intensified                                     anticoagulation interventions? A report indicates that some patients                   who die of COVID have many blood clots found in the lungs.  A                         hypercoagulable state is well described in patients with pneumonia and             sepsis.  Elevated D-dimer and elevated IL-6 (mediator of cytokine                     induced coagulation) are correlated with poor outcomes in COVID-19.               Among 21/183 non-survivors hospitalized with COVID-19 pneumonia,               71% met criteria for disseminated intravascular coagulation. In a                       retrospective study of severe COVID-19 cases with coagulopathy,                     heparin was not associated with a benefit in reduction of 28-day                         mortality except in a subset of patients with very high d-dimers levels.               Bottom line: More data are needed to inform these clinical decisions. In             the meantime, in light of patient isolation and limited mobility, we agree             with The American Society of Hematology (ASH) recommendation that             “all hospitalized patients with COVID19 should receive pharmacologic               thromboprophylaxis with low molecular weight heparin (LMWH ) or                   fondaparinux (suggested over unfractionated heparin to reduce                         contact) unless the patient is judged to be at increased bleeding risk.”

That’s it for this week!  We hope this is helpful; again we welcome feedback.  We appreciate all that you and your team are doing to support your patients, your community and your families in this challenging time,

Robert Moore, MD MPH MBA
Chief Medical Officer

4/15/20 Primary Care and Public Health COVID Updates

It has been 25-28 days since local and State-wide Orders to Stay at Home was issued, and there are early signs that this (combined with related activities: many essential staff working from home, physical distancing, wearing facial coverings in public) have slowed the rate of new case identification, deaths, hospitalizations, and ICU bed utilization.  It is too soon to ease up on vigorous public health measures, but this trend, combined with analysis of current bed capacity suggests that the peak number of cases for this first wave of COVID-19 in our region may not stress our health care delivery system as severely as we were concerned about earlier.  The price of this apparent success is a large non-immune (and therefore susceptible to COVID) population which can lead to rapid focal outbreaks as public health measures are eased.  Yesterday Governor Newsom described the outline of how this delicate task might unfold.

A major task for outpatient providers will be to establish trust in the population that they can safely come in to the office for important medical, dental, vision, lab, radiology and physical therapy visits (that cannot adequately be done via video visits), even while many public health restrictions remain in place.  To be successful, practices will need to pair careful adherence to rigorous infection control procedures with a positive yet nuanced marketing campaign.

Here is a summary of major updates from PHC, the state and the medical word related to COVID-19, from the last 5 days.

1. Policy Updates:

A. Pending Changes to the 2020 PCP QIP: Due to the extenuating                        circumstances related to COVID-19, PHC’s internal and external                        committees have made recommendations for changes to the 2020 Primary      Care Provider Quality Improvement Program (PCP QIP).  The Core                  Measurement Set will be modified to a smaller group of measures, with            more attainable benchmark goals, as noted below.

Proposed Point Allocation and Threshold Changes:

  Family Practice Internal Medicine Pediatrics 50th Percentile
Clinical Measures Points per measure Full Points
Well-Child  Visit, First 15 months of Life (W15) 15.0 25.0 65.83%
Controlling High Blood Pressure (CBP) 15.0 20.0 61.04%
Colorectal Cancer Screening (COL)* 12.5 20.0 32.24%
Diabetes – HbA1C Good Control <9 (A1c) (CDC) 12.5 20.0 50.97%
Childhood Immunization Combo 10 (CIS-10) 15.0 25.0 34.79%
Asthma Medication Ratio (AMR) 15.0 20.0 25.0 63.58%
Non-Clinical Measures      
PCP Office Visits** 15.0 20.0 25.0 TBD
TOTAL POINTS AVAILABLE 100.0 100.0 100.0

* Colorectal Cancer Screening is the only measure in the PCP QIP that does not have an NCQA Threshold equivalent for PHC. The threshold here is the 25th percentile across the entire plan.

** The threshold for PCP Office Visits will be established after PHC has more data on the impact of the COVID-19 Pandemic and orders to shelter in place.

    The specifications for measures in the Core Measurement Set are not              changing, but some specification modifications are proposed for several            Unit of Service Measures.  Of note, we are lowering the thresholds for              submission of attestations for advance care planning conversations and            Advance Directives/POLST form updating.  This is an excellent time to              focus attention on this measure, as noted below.

    This collection of changes is a proposal that is pending final approval       and final specifications.  Final approval will be obtained from our               Physician Advisory Committee, in early May 2020.  The final details and       full specifications will be released by Mid-May 2020.  We are informing you       of the highlights of the Core Measure Set Changes so you can align your         activities to this more focused group of measures.

B. Difficult Conversations in the Time of COVID-19. Geriatricians are noting           greater receptivity to advance care planning conversations during the               COVID pandemic.  If your PCP practice has extra capacity, you may be             considering outreaching to more vulnerable patients to update their                   advance directives and POLST forms.  The Coalition for Compassionate           Care of California is hosting a free webinar today at noon by an expert in           palliative care communication, Robert Arnold.  A recording of this webinar         will be available afterwards on their website.  An excellent prior webinar             covering advance care planning in a virtual visit environment and other             COVID-specific issues is also available, on the same page.  The Coalition         also has put together an excellent COVID Conversations Toolbox with               other resources.

C. Presumptive Eligibility for Uninsured or Underinsured individuals with                COVID.  The Department of Health Care Services (DHCS) is creating a            new aid code that will allow individuals to seek the necessary diagnostic            testing, testing-related services, and treatment services, including all                medically necessary care, through the Medi-Cal fee-for-service (FFS)            program.  This new aid code will be available to California residents with          no insurance or who currently have private insurance that does not cover          diagnostic testing, testing-related services, and treatment service, including      all medically necessary care for COVID-19.  It will be available, regardless        of the person’s immigration status, income, or resources.

    The covered diagnostic test, testing-related services, and treatment                  services, including all medically necessary care such as the associated            office, clinic, or emergency room visit are paid up to the maximum FFS              Medi-Cal rate.  Individuals in this program will not be enrolled in a              Medi-Cal managed care plan, so services must be billed through FFS. 

D. DHCS requested flexibility on timing of Initial Health Assessments (IHA) for       new Medi-Cal beneficiaries.  CMS requires DHCS to require the health             plans to ensure that all new Medi-Cal beneficiaries have an initial health           assessment (a first visit, including a health screening with the DHCS’s               Staying Healthy Assessment questionnaire.  Normally this assessment             includes an examination and must occur within 120 days of enrollment into       Medi-Cal Managed care.  Since a new Medi-Cal member has 1 month to           select a PCP, the assigned PCP has about 90 days to complete this                   assessment.

     Four days ago, DHCS requested the flexibility to have up to 180 days to           complete this initial assessment.  We will monitor this and inform you when       CMS responds.  In the meantime, as mentioned in the last email (related to       state prisoner release), we hope you will develop a process for conducting       new patient intake appointments through virtual visits.

2. Coronavirus PCR Testing

A. Quest issued an updated specimen collection guide (attached). This                   includes the methodology for collecting nasal swab specimens (which can         be self-collected), as well as a number of permitted substitutions for scarce       collection gathering supplies.

B. Scarce testing materials being spread out.  Quest informed us that due to         regulatory reasons related to responding to a shortage of supplies, testing         materials that are sent out must be mostly used up before replacement             testing materials are replenished.  This means that most large volume               testers will be frequently feeling like they are on the verge of running out of       supplies.  Close communication as any particular component of testing             runs low is important.

C. Adapting testing recommendations in office setting as tests become more        available.  The CDC recommends that individuals with mild illness consult        their medical provider to decide if they should be tested or not.  Office-              based testing criteria may be looser than County Health Department                  criteria for testing.  If patient is staying at home anyway, there is little                  urgency in identifying milder cases of COVID.

    As testing becomes more available, and as Stay at Home Orders are lifted,      we must think differently about testing milder illness to identify clusters of          infection earlier.  County Health Departments will be involved in making            recommendations to their local PCPs about testing criteria.  If a PCP has          plenty of testing capacity, be sure to let your local health department know,        so they can guide you on what criteria to use to expand testing.

     Examples of expanded testing strategies:  The county health department           may ask PCPs to assist with testing known contacts of confirmed COVID         cases or doing follow up testing on patients with suspicious symptoms with       a negative initial test, for example.  They may ask a subset of providers to         test all patients with mild respiratory symptoms as part of community                 surveillance or recommend testing anyone with any level of suspicious             symptoms (something being done in Michigan).  With sufficient capacity,           some testing of asymptomatic essential workers (e.g. grocery store clerks,       bus drivers, EMTs, hardware store workers) who are regularly exposed to         the public may be helpful to prevent asymptomatic transmission.  A                   hospital in New York tested all pregnant women arriving in labor, and found       14% of asymptomatic women tested positive, prompting precautions to             prevent spread in the hospital.

     These are but a few options.  Developing a local strategy for scaling up             testing as it becomes more available is worth a joint discussion between           local clinicians and public health leaders.

D. PCR tests vs. Imaging for confirming COVID.  The sensitivity of COVID             PCR tests is fair (around 70%), and the results take a while to come back.         An emergency room in New York found that half of all patients with COVID       had an abnormal chest X-ray (usually bilateral, peripheral or basilar                   pattern,  sometimes described as ground glass interstitial pneumonitis).  A         study in China, among patients admitted with COVID, found that 95% had         an abnormal CT scan of a particular pattern.  Some radiologists in the US         have been hesitant to recommend using CT for diagnosis, citing concerns         about the need to sterilize the CT scanner after scanning a patient with             suspicious symptoms.  As their primary justification, they state that there           are methodological problems with the studies published so for on CT’s               specificity for COVID.

     Decisions to test a patient should not be dominated by concern over                 cleaning the equipment.  If patient with hypoxia and a normal Chest X-ray         is admitted to the hospital, given the differential diagnosis, a CT scan                 would often be helpful in ruling out non-COVID pathology, as well as                 helping with in-hospital disposition if the patient does have a pattern                 consistent with COVID, while awaiting PCR test results which have only a         70% sensitivity.

3. Coronavirus Antibody Tests  (Thanks to Dr. Marshall Kubota for gathering these studies) 

A. Pattern of Development of Neutralizing Antibodies.  A Chinese study of 175       patients with COVID found that SARS-CoV2 specific neutralizing                       antibodies developed starting 10-15 days after “onset of disease.”  Patients       with milder disease had lower plasma titers of these antibodies than those         with more severe disease.  Ten patients with confirmed COVID had                   undetectable antibodies, suggesting either a poor response or perhaps that       the PCR test/clinical diagnosis had a specificity of 94% to match its                   sensitivity of 70%.

B. Similar pattern of antibodies was found in a Norwegian Study of H1N1,            which found that 2/46 patients diagnosed with mild H1N1 had no                        detectable antibodies to H1N1.  Again, this may reflect either a poor                  generation of an immune response or a specificity of 96% in the initial                diagnostic test for H1N1.

C. Other Coronaviruses Exhibit waning Immunity over Time.  Interviews of             experts by NPR noted that the more benign coronaviruses that cause the         common cold can cause repeat sickness, even if a person has a                       documented prior antibody response.  Speculations on potential reasons           include genetic variation of the virus over time or some other factor that             impacts the effectiveness of antibodies from prior infection.  Since classic         SARS was found to have a more robust and long-term immune response,         and they were all symptomatic with serious infection, this supports the               hypothesis that surviving more serious illness generates a longer-lasting           and stronger response.

4. Bio-aerosols and masks

A. The study that prompted CDC to recommend wearing face coverings in             public showed that surgical masks reduced coronavirus detection and viral       copies in large respiratory droplets and aerosols from exhaled breathing           (versus coughing, in which some spread occurs with any facial covering).

B. Another study pointing toward potential aerosol spread was done at the US      biohazard containment center in Nebraska.  Presented at a National                  Academy of Science Webinar, Dr. John-Martin Lowe showed that viral RNA      was detected at distances greater than 6 feet from 82% of COVID positive        outpatients in a quarantine facility and was also detectable in air samples in      the hallways outside the patient rooms.  It is not known yet if this viral DNA        was part of infectious viral particles.  In the Q&A, Dr. Lowe quoted a                  Singaporean study that showed that viral RNA was found on particles 1-4          microns in size (bio-aerosol size).  He said it was better to think of Droplet        and Aerosol as being part of a continuum of infectiousness and infectivity in      COVID.  This means that perhaps the aerosol infectivity is less than                  measles, it can still be transmitted via aerosols, particularly in closed                spaces where the infectious aerosols can build up in concentration to a            dose sufficient to infect those who spend time in that space.

C. Dry heat better than autoclave for sterilizing N95 masks for re-use.                    (Thanks  to Dr. Mills Matheson for finding this reference.)  In an earlier              email a couple of weeks ago, I reviewed an article showing that autoclaving      preserved filtration better than alcohol, ultraviolet light and gas sterilization.      A better study looking at various conditions shows that heating masks to           170-200 degrees Farenheit for 30 minutes resulted in a trivial loss of                  filtration, even when repeated 20-50 times.  Filtration started to drop off            steeply at temperatures over 212 degrees.  Steam resulted in greater loss        of filtration integrity (about 2% per steam cycle), explaining why                          autoclaved N95 masks should probably be discarded after just a few                autoclaved cycles, and why the rice cooker sterilization method mentioned        in a prior email is done without adding water to the rice cooker.  A CDC              summary of methods of re-using N95 is not very helpful, listing many                options but not distinguishing between them very well.

5. Other Scientific Updates 

A. Case report of Guillain Barre syndrome associated with onset of COVID            (“parainfectious profile”) instead of “postinfectious profile” seen with Zika          and other viruses.

B. Studies of Compassionate Use of Convalescent Plasma.  The same NAS        webinar as noted above described the state of knowledge of studies of              using plasma from patients who have recovered from COVID to treat                critically ill patients with COVID.  Earlier studies in classic SARS found a          tripled survival rate associated with this treatment.  Starting March 24, the        FDA has allowed compassionate use of convalescent plasma to treat                COVID.  A clinical trial was started on April 3 at Johns Hopkins.  On April 8,      the FDA published recommendations on its use.  Blood banks can collect          plasma from patients recovered from COVID.  See the American Red Cross      website for screening criteria.  For a moving account of one New York City        Oncologist’s effort to find matching plasma for her critically ill brother-in-            law’s father, see this article in the Atlantic.  One recovered patient’s plasma      can be used to treat 3 critically ill patients.

C. Compassionate Use Experience of Remdesivir.  This summary of                       experience with the use of Remdesivir based on compassionate use in             hospitalized patients suggested better outcomes compared to historical             experience.  Controlled trials are in progress.

6. On a lighter note: Personalizing care while wearing full PPE:  put your                       portrait onto your gown.

PPE Portraits

PPE Portraits

See this document for details, credits and a how-to guide.  “PPE Portraits are simply disposable portrait picture stickers (4×5) put on PPE – personal protective equipment.  Anecdotal pilot data captured during treatment of Ebola showed the PPE Portrait Project helped patients feel connected to their caregivers, and helped healthcare workers feel more like a team and less dehumanized, though this has yet to be formally studied.  From a placebo standpoint, we know that provider warmth and competence are positively associated with physiological health biomarkers.  From our standpoint, PPE signals competence; portraits could be one of the only signals of warmth for COVID19 and potentially-COVID19 patients.”

Thanks for your hard work and innovative spirit in this challenging time!

Robert Moore, MD MPH MBA,
Chief Medical Officer