California Department of Public Health Center for Infectious Diseases February 11, 2020 11:00 am – 12:00 pm I. Overview: Thank you for joining the call this morning. We have three topics that we are looking forward to discussing with you: • • • Laboratory testing in California Notification process for returning travelers from China Recent Centers for Disease Control and Prevention (CDC) guidance related to health care workers The World Health Organization (WHO) announced that they have named the disease caused by 2019 novel coronavirus as “coronavirus disease 2019.” This is abbreviated COVID-19. The number of reported cases continues to grow significantly in China. There have now been over 42,000 cases and over 1,000 deaths in China. Another almost 400 cases have been reported in 24 other countries. Hubei Province continues to have the highest number of cases within China at almost 32,000. However, there are three other region or cities with more than a thousand cases and an additional 19 regions or cities with more than 100 cases. In the United Since there are now a total of 13 US cases. A case under federal jurisdiction was reported last night. This individual was among those repatriated from Hubei Province and was being quarantined on a federal facility in California. The individual had very limited interaction with the general population in California, but was seen at a health care facility in San Diego County. Otherwise, California’s case count remains at six. To date, more than 130 California residents have been tested for 2019 novel coronavirus at the CDC laboratory. As testing becomes available in California, several issues will need to be addressed including assignment of specimen tracking numbers and decision making about who should be tested. One thing that is important to know is that the Emergency Use Authorization (EUA) for this test says that laboratories must follow CDC guidelines for who can be tested. We are still getting input from CDC and determining some details of how to request testing at CDPH. Please await definitive guidance from us before sending specimens to Viral and Rickettsial Disease Laboratory (VRDL). Also, procedures for test approval and submission at other public health laboratories in California will be determined by those laboratories and local health departments. That said, here is a proposed outline of the approval process for VRDL. In general, testing by VRDL will be reserved for patients meeting the defined CDC Person Under Investigation (PUI) criteria. Testing requests for patients who do not meet the CDC PUI criteria may be approved on a case by case basis if requested by local health officers, depending on risk, and other specific circumstances of the patient involved. If testing outside of the defined CDC PUI criteria is requested, we will provide a procedure for the local health officer (or designee) to contact CDPH to obtain approval from a member of the CDPH nCoV clinical team. At this time, we expect that testing will still require contacting CDC to obtain a CDC PUI number, but this number will not be tied to CDC approval of testing. Please stay tuned, as this is likely to shift in the coming weeks. We expect the following workflow for testing at VRDL: • • A provider with a suspected case contacts the Local Health Department (LHD) to request testing. The LHD assesses whether the suspect meets the CDC PUI criteria. Clinical Features Fever1 or signs/symptoms of lower respiratory illness (e.g. cough or shortness of breath) & AND Epidemiologic Risk Any person, including health care workers, who has had close contact2 with a laboratory-confirmed3,4 2019-nCoV patient within 14 days of symptom onset Fever1 and signs/symptoms of a lower respiratory illness (e.g., cough or AND shortness of breath) A history of travel from Hubei Province, China5 within 14 days of symptom onset Fever1 and signs/symptoms of a lower respiratory illness (e.g., cough or AND shortness of breath) requiring hospitalization4 A history of travel from mainland China5 within 14 days of symptom onset • If criteria are met, the LHD completes the PUI form (a modified version of this form in the works) and contacts CDC Emergency Operations Center (EOC) to get a PUI number • o The PUI form with the number will be sent to CDPH novelvirus@cdph.ca.gov inbox, and also routinely included with the specimen shipped to VRDL. We may give specific labeling instructions— again, please stay tuned. If the criteria are not met but LHD believes the suspect should be tested, the LHD will contact the clinical team to discuss the case, using a procedure we will share with the LHDs. If approval is given, then, as above, the LHD should contact CDC EOC to obtain a PUI number. The PUI form, including the assigned PUI number, should be sent to novelvirus@cdph.ca.gov and included with the shipment sent to VRDL. The PUI form will include documentation of the approval. II. Lab Testing: The EUA assay for detection of nCoV from respiratory specimens was released last week. Several California Public Health Laboratories (PHLs) received the kit and proceeded with verification of the assay this past weekend in order to have testing available as soon as possible. Unfortunately, all 6 PHLs, including the VRDL have seen aberrant/sporadic reactions with one test reagent. At this time, PHLs are waiting for guidance from the CDC and Food and Drug Administration (FDA) on how to proceed in order to be able to implement EUA testing. At this time, VRDL remains poised to begin its EUA testing program, pending approval as indicated above.* *Update since call: a new lot of the aberrant component will be prepared by CDC and shipped to PHLs within days (number of days unspecified). NOTE about Electronic Lab Results (ELRs): ELRs are coming into CalREDIE staging that are incorrectly labeled as novel coronavirus when they are actually other non-specific respiratory virus. LHDs should not import these nonspecific respiratory virus results to the novel coronavirus incident. CDPH is aware of this issue and are working to remedy it. III. Returning Traveler Monitoring: First, we would like to acknowledge what a big lift this has been/is, and the bumps along the way. Thank you for your partnership and willing to work with us as we get this going. We recognize that there have been multiple issues with data: • • • • Travelers flagged who have had travel outside of the 14 day period Missed travelers Incomplete, or incorrect contact information Travelers belonging to another jurisdiction Additionally, we recognize that there have been many emails. We have been working very hard to consolidate this and get you only one email. As of Sunday, February 9, jurisdictions should only be receiving one email from us with a compiled list of returning travelers from that day. We recognize that this process has been frustrating and appreciate your patience as we work to try to make it smoother and easier for everyone. Over the weekend we received several hundred Epidemic Information Exchange (Epi-X) notifications which amounted to about 4,000 travelers. We would like to recognize the big lift this requires at the local level and thank you for being patient with us and for raising issues as you see them. These issues are not unique to California and on multiple calls with CDC these issues have been raised. CDC is working to improve data quality and we hope in the coming days that some of the issues may be resolved. Additionally, we recognize that this situation is receiving a lot of media interest and probably has contributed to anxiety in the community. We are always here to help brainstorm and listen, so please reach out at any time. We would like to clarify the process a bit. Currently, Customs and Border Patrol (CBP) are flagging persons for initial screening at the time when passengers present passports. As you know, foreign nationals who have been in China within the past 14 days are not allowed entry to the US. Only US citizens, permanent residents, and their immediate families are allowed to return to the US from China at this time. Passengers with travel to China in their itineraries are being routed to one of 11 airports in the US including San Francisco (SFO) and Los Angeles International Airports (LAX). At passport control, these persons are asked by CBP whether or not they have traveled to Hubei province, if they are ill, and confirming their contact information and final destination. If they have traveled to Hubei province, they will be subject to federal quarantine for 14 days and not allowed to travel to their final destination. Additionally, if they have travel to mainland China and are symptomatic, they will be quarantined. If the passenger traveled only within mainland China, and they are asymptomatic, they will be screened by Division of Global Migration and Quarantine (DGMQ). DGMQ is not performing a full risk screening at this time, they are only ensuring persons are asymptomatic. Therefore, for all persons who are returning from or had travel to mainland China that are allowed to continue to their final destination will be assigned the risk status of Medium Risk by DGMQ. DGMQ is obtaining the list of passengers from CBP and then sending this out to the states via Epi-X for each flight. They are sending notifications approximately twice daily at 9 and 4 EST. They are sending notifications out by flight number and are unable to consolidate the lists at this time. CDPH then takes the Epi-X and determines county of residence. The passengers are then sorted and emails are generated with the list for each local health department. CDPH is working to ensure that the notifications we send out to the local health departments will only go out one to two times daily. Notifications will be sent out in the afternoon after receipt of the final Epi-X for the day from CDC. Please note, you may also receive additional notifications regarding flight contacts and/or cruise ship contacts to known cases are brought to our attention. Jurisdictions may also receive a separate email from us when a returning traveler is transferred from another jurisdiction. We are trying to consolidate this as much as possible balancing it with the need to know and times when it may be actionable. For instance, we do not plan to send late notifications that cannot be acted upon until the next day. A few big points to highlight: • • CDC DGMQ is NOT completing a full risk assessment on returning travelers Some travelers may have additional risks that have NOT been assessed by DGMQ If local resources allow, when the LHD contacts returning travelers, in addition to providing information on self-monitoring, self-quarantine, and how to seek medical care if needed, LHDs should conduct a risk assessment to ensure that returning travelers do not have additional risks that would place them into the high risk category. The following questions help determine if a returning traveler should be classified as high risk. In the last 14 days, has the traveler: o Lived in the same household as, or o Been an intimate partner of, or o Provided care in a non-healthcare setting (e.g., home) For a person with symptomatic laboratory-confirmed 2019-nCoV infection without using recommended precautions for home care and home isolation. Or to a person diagnosed clinically with 2019-nCoV outside of the United States. If yes to any of those questions the traveler will be considered High Risk and require active monitoring. CDC recommends that travelers returning from China at Medium Risk conduct self-monitoring with public health surveillance Additionally, travelers who left China > 14 days prior to arrival in US do not require additional monitoring. Self-monitoring with public health surveillance means public health authorities assume the responsibility for oversight of self-monitoring. CDC recommends that health departments establish initial communication with these persons, ensure the travelers are asymptomatic, provide a plan for self-monitoring and clear instructions for notifying the health department before the person seeks health care if they develop fever, cough, or difficulty breathing, and as resources allow, check in intermittently with these people over the course of the selfmonitoring period. The exact mechanism of self-monitoring with public health supervision will be at the discretion of the LHD (e.g., check in via email, phone, text, frequency of contact) depending on needs and resources of the LHD. At this time, CDPH would like to request that local health departments let us know that you have received the notification. CDC is currently asking for data that travelers have been contacted. This may change over time. We recognize that some LHDs have received hundreds of returning travelers and data collection may be very challenging. At CDPH we are working to explore a number of data collection options including Text Illness Monitoring (TIM), and others. We are working to stand up a CalREDIE module for returning traveler monitoring and right now have provided LHDs with an excel sheet to assist with tracking. This is an area we are actively exploring and would like to get your thoughts on what is feasible. The CalREDIE condition will be called Novel Coronavirus Traveler (nCoV-2019). IV. Infection Control: Healthcare personnel exposure risk assessment and monitoring guidance: On February 8, 2020, CDC released Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with 2019 Novel Coronavirus (2019-nCoV), and yesterday CDPH distributed this guidance via an All Facilities Letter (AFL). This interim guidance is intended to assist with assessment of risk, monitoring, and work restriction decisions for Healthcare Personnel (HCP) with potential exposure to 2019-nCoV in healthcare settings. The guidance includes multiple risk categories – high, medium, low, and no identifiable risk – and corresponding monitoring and work restriction recommendations for each category. There are multiple factors that are used in varying combinations to determine risk categories, including: • • • • • The duration of exposure (e.g., longer exposure time likely increases exposure risk) Clinical symptoms of the patient (e.g., coughing likely increases exposure risk) Whether the patient was wearing a facemask (which can efficiently block respiratory secretions from contaminating others and the environment) Whether an aerosol generating procedure was performed The types of Personal Protective Equipment (PPE) used by HCP The guidance includes multiple permutations and scenarios for each of the risk categories. Health facilities should use this guidance in coordination with their local public health department to assess risk, determine the need for work restrictions, and guide monitoring decisions. The guidance is admittedly somewhat complex. As always, CDPH HealthcareAssociated Infections (HAI) Program staff can provide assistance to LHDs with these assessments. HCP with potential travel or community exposures to 2019-nCoV should have their exposure risk assessed according CDC guidance for travel or community-associated exposures. HCP who fall into the high- or medium- risk category described there should undergo monitoring as defined by their local public health authority and be excluded from work in a healthcare setting until 14 days after their exposure. Healthcare facilities should additionally consider work exclusion for HCP that returned from China before the CDC guidance became effective on February 3, 2020, and are still within the 14 day incubation period. Strategies for optimizing the supply of N95 respirators: We’ve received a number of questions and reports regarding shortages, actual or anticipated, of N95 respirators. CDC just posted several “Strategies for Optimizing the Supply of N95 respirators,” which outline multiple approaches to conserve supplies while safeguarding HCP, including: • • • Minimizing the number of HCP who need to use respiratory protection through the preferential use of engineering and administrative controls - for example, training HCP on appropriate uses of N95 respirators and restricting inappropriate uses, and limiting the number of HCP that enter the room of patients on airborne precautions; Using alternatives to N95 respirators (e.g., other classes of filtering facepiece respirators, elastomeric half-mask and full facepiece air-purifying respirators, powered air-purifying respirators which can be reprocessed and reused); Implementing practices allowing extended use and/or limited reuse of N95 respirators, when acceptable One limited re-use strategy is to save respirators used during an individual HCP’s fit testing for use during patient care. This would apply only if qualitative and not quantitative fit testing is conducted. Another limited re-use strategy is for HCP to reuse their N95 respirators when caring for patients with tuberculosis, for which contact transmission is not a concern. At this time, re-use of N95 respirators while caring for patients with novel coronavirus infection is not recommended, since Contact precautions are needed in addition to Airborne precautions, because of concern for contamination of the surface of the respirator that could contaminate HCP hands during doffing and re-donning. With all of this guidance, please be aware that it’s interim guidance and CDC is continually updating it as we learn more. V. Question and Answer: Q: For counties who have not received reagent kits at their PHLs, are these being held until the testing component issue is being worked out? A: Today there is a call regarding these lab issues that may have an update on this. Currently, this is unknown. The CDC intends to send out a new batch of the N3 problematic component, but it is not confirmed if those who have already ordered kits will receive the new lots. Q: A 14-day quarantine was issued on the Diamond Princess. There are San Luis Obispo residents on the ship and the county is receiving many media questions. How are people being quarantined? Is this 14 days from the last 2019-nCoV exposure? A: This is currently unknown and will be up to the local authorities to determine. This is a challenging reality where some individuals may need to have their quarantine times reset due to continuing exposure. Q: For those individuals who are medium-risk and require LHD monitoring, are there recommended PPE for staff who will be checking on these individuals in person? A: It is not recommended that staff make direct contact with these individuals if possible. The CDC healthcare personnel guidance for collecting specimen states that there is low-risk exposure, so self-monitoring for the healthcare worker is recommended. Likely this would be a similar recommendation if direct contact must be made. Q: Is there any other recommendation for healthcare workers who may have other potential 2019-nCoV exposure besides those associated with mainland China? A: The main concern is for those who have traveled to mainland China or have had contact with known confirmed cases. At this time there is no additional restriction or self-isolation that would be necessary who those who have traveled elsewhere. Q: Is there a reason that Occupational Safety and Health Administration (OSHA) is recommending P100 masks? A: There is guidance on the CDC website for Emergency Medical Services (EMA) and emergency responders regarding respirators. The precautions for PPE are still the same. There is a consideration for trying to obtain these P100 respirators for aerosol generated procedures performed by EMS providers. Q: How does the LHD assess the risk of those individuals who have been reported as being to mainland China, but who have stated they did not actually travel to mainland China? A: Currently, the CDC is not able to verify itineraries and they are taking the word of the travelers. Q: What are the criteria for risk-assessment regarding layovers in mainland China? A: The CDC has stated that if a traveler has a layover in China, they are not considering this an exposure. This may be handled on a case-by-case basis depending on length of the layover. Q: What are the LHD expectations for following up with travelers? The lists being provided are very inaccurate and LHDs cannot get ahold of individuals. Also, some travelers claim they did not travel to China. A: CDC Guidance is flexible and they are leaving the follow-up to LHD discretion. With the data quality issue, LHDs can only do what is possible and reasonable. There is no expectation for how often LHD are checking in, as the CDC has been very clear that the jurisdiction makes the decision. However, the CDC has provided specific guidance that travelers should be contacted within 72 hours of LHD receiving the data/notification. Q: What information is the traveler receiving when they arrive at Customs and Border Patrol? Can CDPH provide the CARE kit and CDC card that the traveler is given? A: Information for arriving travelers is available at the following CDC link: https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html Q: If a PUI tests negative, is this enough to end the isolation period? If monitoring is to continue, is this from the symptom onset date or the last exposure date? A: If a quarantined person develops symptoms (therefore becoming a PUI), and tests negative, we trust that the person was not infected at the time the specimens were collected. However, if the person is still within the 14 day quarantine/incubation period from their last exposure to China or to a case, we would want them to remain quarantined through the end of their quarantine period. This is because even though they weren’t infected at the time they were tested, they could potentially develop infection later in the 14 day period. If re-exposure occurs, the 14-day duration will restart. The 14-day period is the last day of their exposure, not the date they became symptomatic. Q: The CDC has said that all repatriated flights are finished. However, at the current 11 receiving airports, are arriving passengers to be quarantined for the entire duration in the county they arrive in? A: The repatriation flight information is from the Federal government, so we cannot confirm if flights are finished. Symptomatic individuals identified at the airport have been transported to one of the federal quarantine locations that is available now, but we will have to monitor the situation. As the federal government decides to mobilize or demobilize locations, these quarantine locations may change.