Northwell Health LaboratoriesLessons Learned from the COVID-19 Response

CLIAC, October 28, 2020

James M Crawford, MD, PhDjcrawford1@northwell.edu

Senior Vice President for Laboratory ServicesNorthwell Health

Professor and Chair, Pathology/Lab MedicineDonald and Barbara Zucker School of

Medicine at Hofstra/Northwell

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mailto:jcrawford1@northwell.edu

NEW YORK TIMESCoronavirus in the U.S. Latest Map and Case Count April 24, 2020

April 8, 2020: When we did not knowhow this was going to turn out!

COVID-19 PCR Testing: Onset of the Pandemic

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Through Oct 10, 2020

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Northwell Health: COVID-19 statistics (Mar 1 - Sept 30, 2020)

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• Inpatient Post-Acute Care >16,000 patients• Maximum Daily Census >3,000 inpatients (Apr 3-15, 2020)• Current COVID Census (Oct 15) 135 inpatients

• Inpatient Deaths 3,312 deaths (21% mortality)• Maximum Daily COVID Deaths 92 system-wide (Apr 14, 2020)• Usual Daily Deaths (all causes)

Clinical Infectious Disease Major ArticleRapid Emergence of SARS-CoV-2 in the Greater New York Metropolitan Area:

Geolocation, Demographics, Positivity Rates, and Hospitalization for 46 793 Persons Tested by Northwell Health

July 8, 2020 DOI: 10.1093/ciaa922

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Cumulative cases by Zip Code (% of Population)

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Disposition of Tested Persons Mar 3 – Apr 10, 2020

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SARS-CoV-2 % Test Positivity Rates vs. Average Household Income, by Zip Code*

At face value, there appears to be equitableaccess of persons to Northwell SARS-CoV-2 testing

by zip code, regardless of Average Household Income

*% Test Positivity Rates are negatively correlated with Zip Code average annual household income ($25K - $125K),

reflecting increased penetration of SARS-CoV-2in these communities

*36,177 tested persons in 174 zip codes

Reichberg SB, et al. Clin Infect Dis, 8 Jul 2020; DOI: 10.1093/cic/ciaa922

Prevalence of health conditions across census tracts, by median household income and raceThe New York Times June 4, 2020

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Northwell Testing, April 26 to June 30, 2020

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What are the “Lessons Learned”?

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We

have

bee

n he

re b

efor

e….

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“Lessons Learned”: Pandemic (novel H1N1) (Apr 24 – Jun, 2009)

• Decisive and immediate response to laboratory needs (Apr 27ff)Staffing, Supplies, LIS, Physical Plant, Reporting, Client/Public Relations

• Staffing: Arranging for immediate cross-coverage: technical, non-technical• Coordination: Standardization of testing (incl. LDT), logistics, communications• Reporting*: Patient results; Daily epidemiology; local/civic/state officials/CDC• Client Services: Proactive communication; Responses to FAQs• Public Relations: Civic officials; News media (through system PR Office)

Crawford JM et al., Emerging Infectious Diseases 2010 Jan; DOI 10.3201/eid1601.091167

We believe that there will be future infectious outbreaks that will strain the standing capacity of clinical laboratories, requiringeffective implementation of surge capacity responses independent of public health laboratory support.

*NB: The importance of a Sentinel Laboratory

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When you see the crisis coming, you commit to the response.

(There is no other option.)

“Lessons Learned”: COVID-19 Pandemic (2020) - Strategic

• Working with Civic Authorities is absolutely criticalFDA, NYS DOH, NYC DOH, Nassau/Suffolk/Westchester Counties

• The commitment to “Surge Response” must be relentlessLab leadership; Finance; Procurement; Space; Corporate relations

• Laboratory Incident Command: Clear delineation of duties; Resiliency• Workforce: Safety; Cross-coverage; Non-technical support• Supply Chain: (Essentially) all avenues pursued; major Commitments made• Laboratory Science: Validation; Test Performance; Quality Control• Medical Science: Test Utilization; Patient Outcomes (e.g., False Neg/Pos)• Discovery: Clinical Trials; Observational Science; Investigational Science

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“Lessons Learned”: COVID-19 Pandemic (2020) - Tactical

• Health System Support: Unwavering commitment to the pandemic response• Disaster Response Planning: Good for hurricanes; needs work for pandemics• Phlebotomists: Trained in NP swabbing/PPE (we also trained other HCW)• Staff Redeployment: 24/7 “infield shift”, without additional Med Techs• Health System/Public education: “Lab Medicine 101” + “COVID-19 testing”• Standardization (or not): Diversification of testing platforms (!!)• Supply Monitoring/Inventory Control: System-wide; cross-system resilience• Triage/Prioritization: Limiting access to highest priority Pts, eventually eased• Consumables: 3D manufacture (NP swabs; pipette tips); UTM• Inventory Management: “Just-in-Time” vs. Cost/Space of a Supply Buffer

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The Worst of It: COVID-19 Pandemic (2020)

• Prohibited early laboratory response (LDTs) to this new infectious agent• The Politicization of the Pandemic: including (but not limited to) Testing• The absence of a coherent national response• Lack of agency standardization for reporting during a pandemic• Lack of prioritization for in-system laboratories: Hospital, Core Lab• Hospital Site Testing: Inadequacy of Supply Chain for near-patient testing• Unreliability of Supply Chain: It was hard enough as it was; but when the

rest of the USA became affected, Supply Chain for New York worsened• The Mental Toll: Relentless, day-after-day stress• The sense that Lessons from New York were not heeded

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The Best of It: COVID-19 Pandemic (2020)

• The Workforce: Absolute commitment to the tasks at hand, regardless of risk• The Teamwork: intra-system; statewide/DOH; national laboratory community• The Community: Public Relations, Media, Client Service, Colleagues• Strategies worked: The aggressive commitments; hospital “main-frames”• New York State SARS-CoV-2 Testing Consortium: Lab Leadership/12 AMCs• Association of Pathology Chairs: best-practices/lessons learned• Discovery: Observational/Investigational; Clinical Trials; Test Development

The Inherent Value of the Clinical Laboratory

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COVID-19: Contributions of NY State Depts of Pathology*,**

Pathology: Autopsy, Brain, Kidney, Liver, GI; Transplantation, PlacentaImmunology: including Convalescent PlasmaAssays: Diagnostic, Serologic – commercial and LDTsEpidemiology: Hospitalized Patients; Regional Testing; MortalityPopulations: Pediatric; Geriatric; CancerClinical Trials/Therapeutics; Blood Supply ManagementInvestigative: Vascular; Coag; Genetics; Neutrophil Extracellular Traps; etc.Artificial Intelligence/Predictive AnalyticsDisaster Planning/Surge Response; Environmental Science Education;Leadership

* New York State SARS-CoV-2 Testing Consortium (Lab Leadership of 12 New York State AMCs)**NY State: 7% of U.S. cases; NY State Pathology Departments: 2% of U.S. publications on COVID-19 as of Sept 3, 2020

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Regulations and the COVID-19 Pandemic (selected)

• FDA/CDC/HHS 1/31/20: HHS declaration of public health emergency†2/4/20: HHS declaration of immunity to liability2/4/20: FDA EUA to CDC; CDC prepares to ship2/18/20: CDC warns clinical labs against testing

without FDA approval2/29/20 FDA EUA: authorizing non-public health labs to

develop assays and obtain EUA2/29/20 FDA EUA: authorizing NYS DOH to certify labs3/13/20: US National Emergency declared3/16/20: FDA EUA: allowing states to authorize tests3/25/20: FDA EUA guidance: Remote Digital Pathology

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Regulations and the COVID-19 Pandemic (selected)2

• New York State 3/1-7/20 DOH: validation samples; approvals for NHL*3/7/20 E.O. 202: Suspension/Relaxation of regulations†4/17/20 E.O. 202.18: Reporting requirements4/17/20 E.O. 202.19: Coordination of Lab Testing4/25/20 E.O. 202.24: Licensed Pharmacists/Test Orders5/12/20 E.O. 202.30: Nursing Home/Staff Testing9/9/20 E.O. 202.61: Reporting within 3h, w metadata

*Northwell Health Laboratories

†→ ? Thoughtful re-institution of pre-existing regulations ?

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What has been Gained during COVID-19? What has been Lost?

• Gained Generational Visibility, Education of the PublicWork with Policy Leaders at State levelStrengthened national Laboratory CommunityOpportunity to “lift up” a health system and regionInvestigative Opportunity: Public Health, Medical, Scientific

• Lost? Delayed PCR testing (AMP surveys* April, August 2020):3/21/20: average date AMCs went live with PCR testing4/2/20: average date commercial reference labs

and community hospital labs went liveReliability: Supply Chain, Test PerformanceCredibility: Ability of Lab Testing to inform Society’s Needs

*Association of Molecular Pathology: 113 US labs from 38 states23

Next Steps for Maximizing Value of the Laboratory Contribution

• Innovate/Lead Strong working relationships of Labs and AgenciesPopulation Health/Economic Value of Lab contribution* Optimizing Health Care “in spite of” COVID-19Recovery and Strengthening of Health Care DeliveryImproving Health Care: Is there a better way?

• Measure* Quantitative Patient OutcomesQuantitative Population Health OutcomesQuantitative Economic Outcomes

• Champion Role of Pathology and Laboratory Medicine in:Health CareEducationDiscovery

*Crawford JM et al., Academic Pathology 2017 Apr 19; DOI: 10.1177/2374289517701067: “Lab 2.0”24

Acknowledgmentsjcrawford1@northwell.edu

Dwayne Breining, MD* Cari Gusman*Deborah Schron, MD* Michael Eller*,†

Tylis Chang, MD*,†† Christopher Zavala†Gregory J Berry, PhD* Yehuda Jacobs††

Scott Duong, MD* Samuel Reichberg, MD††Stefan Juretschko, PhD* Aya Haghamad, PharmD††

Joseph Castagnaro* Girish Ramrattan††Richard Tesoriero* Partha Mitra, MD††Hannah Poczter* Alex Drach, MD††Richie Seaberg* Yihe Yang, MD††

James Crawford, MD PhD*,†† Yonah Ziemba, MD††

*COVID-19 Laboratory Incident Command Team†COVID-19 Community Outreach Team

††COVOD-19 Pathology Informatics Team25

mailto:jcrawford1@northwell.edu

Northwell Health Laboratories� Lessons Learned from the COVID-19 Response�CLIAC, October 28, 2020��� James M Crawford, MD, PhD� jcrawford1@northwell.edu �� Senior Vice President for Laboratory Services� Northwell Health� Professor and Chair, Pathology/Lab Medicine� Donald and Barbara Zucker School of� Medicine at Hofstra/Northwell�NEW YORK TIMES�Coronavirus in the U.S. Latest Map and Case Count �April 24, 2020April 8, 2020: When we did not know�how this was going to turn out!Through Oct 10, 2020Northwell Health: COVID-19 statistics (Mar 1 - Sept 30, 2020)Clinical Infectious Disease Major Article�Rapid Emergence of SARS-CoV-2 in the Greater New York Metropolitan Area:�Geolocation, Demographics, Positivity Rates, and Hospitalization for 46 793 Persons Tested by Northwell Health� �July 8, 2020 DOI: 10.1093/ciaa922Cumulative cases by Zip Code (% of Population)�Disposition of Tested Persons Mar 3 – Apr 10, 2020�SARS-CoV-2 % Test Positivity Rates vs. Average Household Income, by Zip Code*Prevalence of health conditions across census tracts, by median household income and race�The New York Times June 4, 2020�Northwell Testing, April 26 to June 30, 2020�What are the “Lessons Learned”?We have been here before….“Lessons Learned”: Pandemic (novel H1N1) (Apr 24 – Jun, 2009)When you see the crisis coming, �you commit to the response.�(There is no other option.)“Lessons Learned”: COVID-19 Pandemic (2020) - Strategic“Lessons Learned”: COVID-19 Pandemic (2020) - TacticalThe Worst of It: COVID-19 Pandemic (2020)The Best of It: COVID-19 Pandemic (2020)COVID-19: Contributions of NY State Depts of Pathology*,**Regulations and the COVID-19 Pandemic (selected)Regulations and the COVID-19 Pandemic (selected)2What has been Gained during COVID-19? What has been Lost?Next Steps for Maximizing Value of the Laboratory ContributionAcknowledgments�jcrawford1@northwell.edu ��Dwayne Breining, MD* Cari Gusman*�Deborah Schron, MD* Michael Eller*,†�Tylis Chang, MD*,†† Christopher Zavala†�Gregory J Berry, PhD* Yehuda Jacobs††�Scott Duong, MD* Samuel Reichberg, MD†† �Stefan Juretschko, PhD* Aya Haghamad, PharmD††�Joseph Castagnaro* Girish Ramrattan††�Richard Tesoriero* Partha Mitra, MD†† �Hannah Poczter* Alex Drach, MD†† �Richie Seaberg* Yihe Yang, MD†† �James Crawford, MD PhD*,†† Yonah Ziemba, MD††��� *COVID-19 Laboratory Incident Command Team� †COVID-19 Community Outreach Team�††COVOD-19 Pathology Informatics Team�