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Lean the Virus - Applying Lean principles to the COVID-19 response

Authors:

Abstract

The country ironically known as the United States experienced a stunning failure of governmental response during a crisis of epic proportions. This paper seeks to contribute to a course correction. As a practitioner of Lean process improvement techniques, I will focus on the operational aspects of the system's malfunctions. What we experienced was the antithesis of Lean. Bidding wars between states amidst supply chain chaos. Inconsistent and redundant data collection. Regulators either too stringent or too lax. This paper describes how lean concepts and techniques can be applied to the pandemic response. It explains how the principles of quality, efficiency, and standard work apply to elements of the response including regulation, supply chain management and data collection. The paper urges the integration of lean principles and techniques into public management systems during this public health crisis and going forward.
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Lean the Virus:
Applying Lean principles to the COVID-19 response
Kate McGovern, MPA, PhD
College Unbound
November 2020
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Lean the Virus: Applying Lean principles to the COVID-19 response
Abstract
The country ironically known as the United States experienced a stunning failure of
governmental response during a crisis of epic proportions. This paper seeks to contribute to a
course correction. As a practitioner of Lean process improvement techniques, I will focus on the
operational aspects of the system’s malfunctions.
What we experienced was the antithesis of Lean. Bidding wars between states amidst supply
chain chaos. Inconsistent and redundant data collection. Regulators either too stringent or too
lax. This paper describes how lean concepts and techniques can be applied to the pandemic
response. It explains how the principles of quality, efficiency, and standard work apply to
elements of the response including regulation, supply chain management and data collection. The
paper urges the integration of lean principles and techniques into public management systems
during this public health crisis and going forward.
Keywords: COVID-19, Lean process improvement, public administration, Lean management
Takeaways
Lean process improvement principles and techniques could be applied to improve critical
aspects of pandemic response.
While the nonfeasance of the administration in power in 2020 was arguably an outlier,
numerous impediments to effective response predated this crisis.
Lean principles are universally applicable to public administration beyond the massive
challenges posed by the pandemic.
Introduction
The world changed abruptly, extensively, and profoundly. Previous assumptions and
expectations were shattered. As a practitioner of Lean process improvement principles, I
struggled to make sense of the short comings in our country’s response. We witnessed a huge
waste in dollars and in effort. We saw the terrible consequences in human suffering. With less
than 5% of the world’s population our country had suffered 19% of the deaths, as of November
1, 2020
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Leaders in the U.S. “have taken a crisis and turned it into a tragedy, the editors of the New
England Journal of Medicine proclaimed. In an unprecedented editorial, they declared that the
magnitude of this failure is astonishing. (Editors, 2020) More than 1,000 former and current
officers of the Centers for Disease Control (CDC) signed an open letter asserting that “The
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Covid-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.
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absence of national leadership on Covid-19 is unprecedented and dangerous (Shinefield, H.,
Grayston, J. T., Barondess, J., et al, 2020).
Much work has been done to assess the public policy failures that caused this country to
experience one of the worst outbreaks in the world. The American Review of Public
Administration (ARPA) devoted a special edition to commentaries on the relationships between
the practice of public administration and the field of public health in the context of the ongoing
coronavirus pandemic(Holzer & Newbold, 2020, p. 6). Among the contributions was “How the
U.S. Flunked the COVID-19 Test” which discussed a range of dysfunction (Xu & Basu, 2020)
providing a series of examples that I characterize as “unlean.”
While continuing to deepen our understanding of what went wrong, new research contributions
are made on a daily basis. It is beyond the scope of this paper to evaluate medical interventions.
Rather, I will examine the response from an operational perspective, seeking to answer the
question: How can lean principles and techniques be applied to improve the pandemic response?
First, a brief introduction to Lean.
Background on Lean
Since the term “lean” was coined by a team of MIT researchers studying the Toyota Production
System, lean principles and techniques have spread across the globe. More than a set of tools to
identify and eliminate waste, and increase value for the customer, it is an operating principle for
smooth flow and standard work. It is also a perspective, a way of thinking. Essentially, it is a
management system.
Among the scholars and practitioners who have contributed to the development of continuous
improvement management systems, W. Edwards Deming (19001993) is perhaps the most
notable. His work as a consultant in Japan following World War II facilitated the resurgence of
that country’s industrial base and set the conceptual foundation for what became the Toyota
Production System (TPS). Deming’s publication, Out of Crisis, described his theory of
management, including his 14 Points for Management (Deming, 1982, p 23-24).
Toyota’s development of continuous improvement techniques was studied by researchers at
MIT's International Motor Vehicle Program. Documented in The Machine that Changed the
World (Womack, Roos, & Jones, 1990), the principles underlying the TPS became known as
lean. Lean draws from a wide range of work from preceding decades by Walter Shewhart,
Kaoru Ishikawa, Shigeo Shingo, Joseph Juran, Kiichiro Toyoda, and Taiichi Ohno, among
others.
Scholars and practitioners contributed to a growing body of knowledge. Jim Womack, co-author
of “The Machine” founded the Lean Enterprise Institute in 1997. In an Afterword for the 2007
edition of The Machine, the authors observed, “it is not surprising that our research has
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continued over nearly two decades, we have learned a great deal about lean production beyond
our original findings” (Womack, J. Roos, D. & Jones, D. 2007, p. 287.)
Extending beyond its origins in manufacturing, Lean was adapted to finance, health care and
government. Researchers for the Government Finance Officers Association addressed its multi-
faceted elements with a comprehensive definition: “Lean is an organizational performance
management system characterized by a collaborative approach between employees and managers
to identify and minimize or eliminate activities that do not create value for the customers of a
business process, or stakeholders.” (Kavanagh & Krings, 2011, p. 19.)
Asked to reflect on the 30th anniversary of “The Machine” in 2020, Jim Womack advised that
“we must stay true to our beliefs – that sustainable change doesn’t happen instantly and through
individual heroic actions alone, but instead through collective efforts to countermeasure
problems on a continuing basis” (Priolo, 2020.)
Lean is not an acronym. It is not copyrighted
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. It is a developing set of continuous improvement
techniques and tools based on core principles. An extensive community of practitioners and
researchers is contributing to an evolving body of knowledge. This paper draws upon that work,
synthesizing the core principles and primary techniques as they could be applied to the pandemic
response. We begin with a summary of several core concepts.
PDCA
Lean practitioners apply the continuous improvement cycle of Plan-Do-Check-Act (PDCA). The
American Society for Quality (ASQ) defines PCDA as A four-step process for quality
improvement. In the first step (plan), a way to effect improvement is developed. In the second step
(do), the plan is carried out. In the third step (check), a study takes place between what was
predicted and what was observed in the previous step. In the last step (act), action should be taken
to correct or improve the process” (American Society for Quality, n.d.). Stabilizing and
documenting the current best practice forms a baseline from which to improve.
Muda, Muri, Mura
Lean practitioners learn about the three Mus: muda, mura and muri.
Muda (waste) is an unnecessary use of resources including time, people, and materials.
There are eight types of wastes: defects, overproduction, waiting, non or underutilized
talent, transportation, inventory, motion, and excess processing. This paper will identify
aspects of the pandemic response which were rife with muda and recommend
countermeasures.
Mura (unevenness or variability) leads to defects, redundancy, and rework. It is opposite
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Lean is not always capitalized. In this paper, I have capitalized it when referring to the practice of Lean, but not
when using it as an adjective.
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of standard work. Deming noted "Uncontrolled variation is the enemy of quality" (W.
Edwards Deming Institute). Lack of consistency was a key impediment to an effective
response.
Muri (overburden) is exacerbated by dealing with muda and mura. For example, public
managers, hospital administrators and elected officials struggled to deal with critical
supply shortages and informational confusion sapping their energy and focus when it was
most needed.
Public Sector Application of Lean
Lean entered the public sector with the same transformative potential it had demonstrated in
private industry. Implementation is challenging for several reasons:
Lean management is counterintuitive to administrators accustomed to layers of
bureaucracy. Risk-averse managers cling to the illusory comfort of requirements for
multiple permissions prior to taking action.
Lean programmatic structures are thwarted by elected officials eager to claim credit for
creating new (often redundant) programs. They allocate funding among a wide range of
public and non-profit entities with overlapping and redundant responsibilities.
Policy makers and administrators tend to establish new regulations or elaborate
procedures to guard against the recurrence of a single negative event. (think shoe
bomber)
There is persistent political pressure to cut public sector budgets in both good times and
bad.
At a time when Lean is most needed to address the complexity and redundancy, the
continuous budget cuts keep public servants in a reactive mode. Struggling to keep up
with current responsibilities, there is neither the resources nor the opportunity for a Lean
initiative.
As the pandemic spread in March 2020, journalist Fareed Zakaria reported that the country was
on track to have a more serious outbreak than other wealthy countries, “Largely because of the
ineffectiveness of its government (Zakaria, 2020). While acknowledging the ineptitude of the
administration, he insisted that “there is a much larger story behind this fiasco” and went on to
explain that “America is paying the price today for decades of defunding government,
politicizing independent agencies, fetishizing local control and demeaning and disparaging
government workers and bureaucrats (Zakaria, 2020).
Zakaria’s analysis is consistent with a lean thinker’s understanding that the functionality of the
organization is as important as the funding level. He notes, “Federal agencies are understaffed
but overburdened with mountains of regulations and politicized mandates and rules giving
officials little power and discretion (Zakaria, 2020). And, the capacity to fight COVID-19 was
further impeded by what he characterized as “America’s crazy quilt patchwork of authority with
thousands of state, local, and tribal public health departments” which are “proving a nightmare
when tackling an epidemic that knows no borders” (Zakaria, 2020). He closed the commentary
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by affirming that the most successful governments are well-funded, efficient, and responsive. A
perfect description of lean government.
An Unlean combination. Leading up to this crisis, local public health agencies had lost almost
a quarter of their overall workforce since 2008 a reduction of almost 60,000 workers” (Janes
& Wan, 2020.) There is also a huge variability in the programmatic capacity of state and local
health departments. Dr. David Himmelstein of the CUNY School of Public Health explained
that many of the functions of local public health departments are dependent on grants from CDC.
“You apply to them for funding for particular functions, and if you don’t get the grant, you don’t
have the funding for that.” He compared the arrangement to having the military apply for grants
to fund its ongoing responsibilities. (Himmelstein in Janes & Wan, 2020.)
This arrangement is absurd to the lean thinker. Consider the amount of effort it takes to develop
grant program criteria at the federal level, the amount of staff time at each public health
department to prepare and submit applications, set up programs and dismantle them depending
upon the funding cycle. And, starting it all over again. Aside from the overall muda of the
situation, paying salaries of public health professionals to move money back and forth falls under
one of the eight types of muda: underutilized human talent.
Opportunity for Lean application
Without attempting to discuss the full range of lean tools or each aspect of the pandemic
response, this paper will illustrate the applicability of core principles and techniques to several
problematic areas. Properly applied, the principles could assist in the design of a system with
economies of scale and quality control. Standard protocols could be developed to allow a nimble
transparent response to state and local conditions. First, we assess the pandemic’s catastrophic
impact and ensuing economic devastation through a lean lens.
A Tragic, Unlean Pandemic Response
What we experienced was the antithesis of Lean. The bidding wars between states, supply chain
chaos and reports of federal confiscation of shipments. States using different models projecting
greater or less dire outcomes, driving purchasing and allocation decisions. Each deciding which
tests to use, how many to buy and how to set up testing stations, hire and train contact tracers.
Overregulation of the diagnostic test in the critical early weeks, followed by under-regulation of
antibody tests.
Muda, Mura, Muri Everywhere
Mura, redundancy, and rework plagued the response at every turn. The most glaring examples
include data collection, travel restrictions and procurement. Even the development and
deployment of technology was rife with redundancy. The smallest state in the country, Rhode
Island, has its own app, “CrushCOVID”. In August, 20 states and territories were developing
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apps to cover nearly half the U.S. population, with examples including “Covidwise” in Virginia,
“Care19 Alert” in North Dakota and “Guidesafe” in Alabama (Fowler, 2020). While rote
standardization could impede innovation, arguably is unlean for every state to develop its own
app. A lean process would minimize redundant use of human talent, time, and cost.
Mura in interstate travel. There is a confounding variation of interstate travel policies as states
struggle to contain the pandemic. Although enforcement of a 14-day quarantine for travelers
within the country is nearly impossible, efforts were made to restrict travel from areas of
significant community spread. States developed criteria exempting certain travelers from the 14-
day quarantine. For example, as of October 28, 2020 each state’s website announced different
guidance:
Vermont: Travel permitted from counties with <400 active cases per million.
New Hampshire: Travel permitted from New England states.
Rhode Island: Travel permitted from states with positivity rate <5%.
Massachusetts: Travel permitted from states with 7-day average daily cases <10 per 100K
AND positive test rate <5%.
Pragmatic considerations altered a tri-state agreement for uniform travel policies between
Connecticut, New York, and New Jersey as New York officials said that despite an uptick in
cases in New Jersey, Connecticut and Pennsylvania, travelers from those neighboring
states would not be required to quarantine, because enforcement would be too difficult
(Haberman, 2020).
Mura of Data. Multiple organizations collected similar but not identical data in different
dashboard formats. Often it was “non-governmental organizations, such as Johns Hopkins
University’s Coronavirus Resource Center (2020), Kaiser Family Foundation (2020a),
and 1Point3Acres (2020), that provide the public with the most up-to-date and most
comprehensive statistics” (Xu & Basu, 2020, p. 570). Harvard based Global Health Initiative
sponsored the Convergence Group which proposed the Key Metrics for COVID Suppression
Framework: Covid Risk Level Case Incidence in July 2020. Other data sources included the
CDC COVID Data Tracker , The Atlantic Tracking Project , the Brown School of Public Health ,
Georgia Tech’s risk assessment planning tool and the New York Times Covid in the U.S.
Among the sources for projections of levels of contagion and mortality were:
The University of Washington’s Institute of Health Metrics and Evaluation (IHME)
forecasted up to four months out, updated weekly. Projected fatalities to be expected if
restrictions were easing, remaining the same, or with universal use of masks.
UMass Amherst Ensemble Forecast Hub Combined models that were unconditional on
particular interventions with those conditional on certain social distancing measures
continuing. Publishes 4 week-ahead forecasts ahead, updated weekly.
An Information Catastrophe. Resolve to Save Lives, a nonprofit headed by former CDC
director Tom Frieden, made a series of recommendations in “Tracking COVID-19 in the United
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States From Information Catastrophe to Empowered Communities. The organization’s report
explained, “Unlike many other countries such as Germany, Senegal, South Korea, and Uganda,
the United States does not have standard, national data on the virus and its control. The U.S. also
lacks standards for state-, county-, and city- level public reporting of this life-and-death
information” (Resolve to Save Lives, 2020).
In addition to the waste of redundancy of effort, the non-standard data collection and reporting
make it difficult to get a clear picture of the extent of the contagion. Hence, data mura obfuscates
decision making. To illustrate the problem, consider one data point: the testing positivity rate.
The Johns Hopkins Coronavirus Resource Center (JHCRC) reported that the World Health
Organization (WHO) advised governments that before reopening, rates of positivity in testing
(ie, out of all tests conducted, how many came back positive for COVID-19) of should remain at
5% or lower for at least 14 days” (Johns Hopkins, 2020).
A positivity rate greater than five percent indicates that only the sickest patients are being tested,
so the level of community contagion is likely much wider. While a positivity less than five
percent can be seen as a sign that a state had sufficient testing capacity for the size of their
outbreak and is testing enough of its population to make informed decisions about reopening”
(Johns Hopkins, 2020).
Looking at the positivity rate of the gross number of tests can be misleading because people in
high risk or high contact jobs may be tested repeatedly to confirm negative status. While this
surveillance testing is essential to containing the outbreak in health care and other settings, the
most significant indicator of the community spread is the percentage of positive cases found
among those who are tested for the first time. Consider the following example:
As of October 28, 2020, the JHCRC reported that there were 16 states with positivity rates less
than 5%. Rhode Island was listed as having a positivity rate of 3.03%. According to the Boston
Globe, Rhode Island’s rate for first time tests was 16% (McGowan, 2020). The discrepancy was
because the state had the highest per capita testing program in the country. Testing was widely
available and State officials encouraged people to get tested, especially for frontline workers.
While the overall positivity rate confirms the importance of a comprehensive testing initiative,
the first-time rate reveals more about the level of community contagion. Both figures have value,
but only in context. Without uniform reporting criteria, state by state comparisons are full of
noisy data.
Guidance and expertise. Absent federal coordination, states designed their own responses
tapping local medical and academic institutional expertise. The Providence Journal reported a
“$1.85-million no-bid contract to a Boston consulting firm to help the state respond to the
pandemic and plan the eventual reopening of the economy.” The report noted that the “contract
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first came to light in a Connecticut Post news report about Gov. Ned Lamont’s hiring of the same
firm the Boston Consulting Group” (Gregg, 2020).
A lean thinker would want to know how many states paid for expertise and guidance that should
have been available through federal coordination. Perhaps it was necessary to hire supplemental
assistance in a surge scenario during a state of emergency. But how much rework, redundancy,
and cost could be avoided through planning and coordination? Are there essential functions that
could be leaned? What follows is a discussion of how the tools and concepts can be applied to
several key elements of the pandemic response.
Unlean Regulation
Since the start of the pandemic, the Federal Drug Administration (FDA) has come under
criticism for being too restrictive on diagnostic tests to be run by universities and private labs,
too lenient with antibody tests and hydroxychloroquine, and equivocating on convalescent
plasma. Political motives were suspected, particularly in agency’s approval of
hydroxychloroquine as a COVID-19 treatment. Aside from the potential injurious health impact
of improper use of the drug, consider the muda of taxpayer funds. Utah alone spent $800,000 to
build up its stockpile of the drug” (Sedensky & Stobbe, 2020.)
Lack of public confidence in the FDA has led some policy makers to propose redundant reviews
of potential vaccines. Governor Andrew Cuomo (NY) assured, "New York state will have its
own review when the federal government has finished with their review and says its safe. (Mann,
2020). Rhode Island’s COVID-19 webpage lists a subcommittee appointed by the Governor that
will “be responsible for developing an independent process for evaluating the safety and efficacy
of the vaccine” (Rhode Island, 2020). After Governor Gavin Newsom (CA) announced a similar
endeavor, the governors of Washington, Oregon, and Nevada opted to join in California’s effort
(Cowan, J., 2020).
It is unlean to divert the time and expertise of professionals to conduct a redundant review.
Better to fix the FDA. "Quality comes not from inspection, but from improvement of the
production process." (Deming, 1982, p. 29). Lean techniques could establish a medically sound,
expeditious and transparent regulatory process.
Lean Regulation
In adapting Lean for the public sector, it is useful to understand a dynamic tension in many
governmental processes. Public administrators have a dual responsibility, delivering services
while assuring compliance. Lean can be used to improve essential services without sacrificing
standards.
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An optimal regulatory process is fair and efficient. It protects the public without placing undue
burden. A sub-optimal process is laden with unreasonable hurdles and delays, commonly known
as red tape. A Kaizen project can lean such a process.
Kaizen is a combination of two Japanese words: kai meaning “to change” and zen meaning “for
the good of all.” To sum it up: “change for the better.” In Lean practice, it is the term for the
process of continuous improvement using problem-solving and analysis techniques. A Kaizen
event is a facilitated, small-scope improvement activity that engages the creativity of employees
to reduce waste in a work process. A kaizen project typically takes 3-5 days.
Leaning the FDA’s COVID 19 Crisis Response. The FDA Commissioner is permitted to grant
Emergency Use Authorizations (EUAs) for “unapproved medical products or unapproved uses of
approved medical products to be used in an emergency to diagnose, treat, or prevent serious or
life-threatening diseases or conditions…when there are no adequate, approved, and available
alternatives” (U.S. FDA, 2020)
It is useful to have a fast lane for exigent circumstances when the due diligence of a methodical
regulatory process is offset by urgent need. No one wants “red tape” to stand in the way of life
saving medicines or vaccines, nor do we want our loved ones to be harmed by unsafe treatments.
A Kaizen event could assess the regulatory process:
Prepare a charter, identify a Lean facilitator, and schedule a Kaizen event.
Convene a team. As with any Lean project, the core team is comprised of the staff who
do the work in the process (in this case, the FDA professionals.) Outside medical
practitioners and academics (subject matter experts who can bring a fresh perspective),
medical product providers (the customers applying for approval), and members of the
public (stakeholders in the outcome) should also be on the team.
Develop a common understanding of the criteria for issuing EUAs.
Map the current state of the process, determining the value of each step. Recommend
process redesign that would enhance the efficiency, quality, integrity, objectivity, and
transparency.
Implement the changes and share the information with the public.
Applying the Kaizen technique to public regulatory processes can find the Goldilocks amount of
regulation: not too little, not too much. It can maximize public protection while minimizing red
tape. A lean regulatory process can require transparent decision-making based on objective
criteria. Such a process could earn back public confidence during this historic emergency.
Muda of Lives
As of November 12, 2020, more than 240,000 Americans have succumbed to the virus
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. Studies
are ongoing to identify the number of lives that could have been saved with various public health
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Covid-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University.
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measures. As researchers have documented that many thousands of lives could still be saved
with appropriate action.
Concerned that the routine tally of hundreds of daily fatalities inures people into acceptance of
the toll as inevitable, Stephen J. Elledge calculated the life years lost. He explained, As
COVID-19 disproportionally impacts elderly populations, the false impression that the impact on
society of these deaths is minimal may be conveyed by some because elderly individuals are
closer to a natural death (Elledge, 2020, p. 1). In a preprint, Elledge looked at 194,000 deaths,
applying actuarial data on life expectancy to estimate that over 2,500,000 person-years of life
had been lost by early October. He noted, “nearly half of the potential years of life lost occur in
non-elderly populations” (Elledge, 2020, p. 1).
Significant work was published in October 2020 documenting the significant impact of
widespread usage of masks.
Dr. Irwin Redlener of the National Center for Disaster Preparedness at Columbia
University estimated that “at least 130,000 of the nation's more than 227,000 deaths could
have been avoided had the country more widely embraced masks and social distancing
(Sedensky & Stobbe, 2020.)
The Institute of Health Metrics and Evaluation (IHME) COVID-19 Forecasting Team
published findings that about 130,000 lives could be saved through February 2021, if
95% of Americans wore masks. (Reiner, R., Barber, R., et al, 2020).
Given the wide variation in policy among and within states, comparative data is increasingly
available. A study by the University of Kansas compared the trend of new cases in counties with
and without mask mandates, finding a 50% reduction in new cases in counties with the
mandates. (Zambrano, C., Ginther, D., & Roberts, R., 2020). Vanderbilt Medical School updated
a previous study and found, “Hospitals that predominantly serve patients from areas without
masking requirements… continue to see the highest rate of growth in hospitalizations” (Graves,
McPheeters, et al 2020, p. 2.)
MedPage Today reported that senior author Christopher Murray of the University of
Washington characterized expanding mask use as an easy win for the U.S.” (Walker, 2020).
The IHME team was among the many other medical practitioners, public health professionals
and researchers endeavoring to send life-saving messages above the noise of a contentious
political campaign.
The failure to use such a simple method to save thousands of people is unlean: low resource
high gain. A lean thinker would also want to know how many people could be prevented from
suffering debilitating long-term health effects. It is beyond the scope of this paper to examine the
pathology of intersecting political and psychological factors. I expect this will be the topic of
extensive study. Through a lean lens, the lack of a public health standard on a matter of this
consequence was extremely wasteful, both in lives and money.
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Lean seeks standard work. “The inconsistency of the response is what’s been so frustrating,”
said Dr. Irwin Redlener of the National Center for Disaster Preparedness at Columbia University.
“If we had just been disciplined about employing all these public health methods early and
aggressively, we would not be in the situation we are in now.” (Sedensky & Stobbe, 2020.)
Lean seeks to develop a common understanding. Countering misinformation will be key to
moving forward with a lean strategy. The Cornell Alliance for Science studied the
“infodemic” by surveying 38 million articles. The study found that “misinformation and
conspiracy theories promulgated by ostensibly grassroots sources, such as antivaccination
groups, 5G opponents, and political extremists, do appear in our analysis…they contributed far
less to the overall volume of misinformation than more powerful actors, in particular the US
President” (Evanega & Lynas, et al. 2020, p.12 ). On October 19, 2020 as COVID cases were
increasing throughout much of the nation, the President “attacked Dr. Anthony S. Fauci as ‘a
disaster.’” He claimed that “people were ‘tired’ of hearing about the virus from ‘these idiots’ in
the government’” (Stolberg, Haberman, & Weiland, 2020).
Muda of Money: Health Care Costs
Reports about health care costs for COVID-19 treatment tend to focus on the out-of-pocket costs
for individuals with various types of medical insurance. The Kaiser Family Foundation (KFF)
has reported on the range of possible co-pays and deductibles for patients requiring in-patient
hospital treatment. (Fehr et al., 2020)
The focus on patient cost was again highlighted when the President proclaimed that everyone
could have the same treatment he had received “for free. (Brewster, 2020) It must be noted that
the President certainly did not mean that the providers would not be paid. Politicians of both
parties have proposed “free” COVID tests and in some cases, treatments. It would be useful to
survey policy proposals indicating how providers would be compensated, particularly with
regard to quality or cost standards. Charges for COVID test can vary widely, while they
typically cost $100, one emergency room in Texas has charged as much as $6,408 for a drive-
through test. (Kliff, 2020)
While the extreme inefficiencies of the U.S. health care market are beyond the scope of this
inquiry, any lean analysis of the pandemic response must address cost. A lean response the
pandemic would include contagion abatement. If the average cost of treating a severe case is
known, it may be possible to extrapolate the cost avoidance.
In March, 2020, FAIR Health calculated the average charge for inpatient treatment at $73,300.
At that point, early in the pandemic, the Brief extrapolated that “the total costs for all
hospitalized COVID-19 patients range from a low of $362 billion in charges and $139 billion in
estimated allowed amounts to a high of $1.449 trillion in charges and $558 billion in estimated
allowed amounts, depending on the incidence rate of the infection in the US population. (FAIR
Health, 2020, p. 2)
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Two papers released in preprint sought to update the figures and extrapolate the mounting
medical costs. In “The Forgotten Numbers: A Closer Look at Covid-19 Non-Fatal Valuations,
Thomas J. Kniesner and Ryan Sullivan estimated that almost a million cases had involved
hospitalizations as of July 27, 2020. Focusing on the cost of non-fatal cases, they calculated an
average of $46,000 per case. Using CDC forecast data to estimate non-fatal valuations through
November 2020, and find that the overall cumulative valuation increases from about $2.2 trillion
to about $5.7 trillion or to about 30 percent of GDP.” (Kniesner & Sullivan, 2020, p. 1)
In “The Contagion Externality of a Superspreading Event: The Sturgis Motorcycle Rally and
COVID-19” the authors used Knie sner and Sulli v ans estimate o f $46,0 0 0 per ca se to
calculate the potential public health cost of $12.2 billion. (Dave, Friedson, McNichols,
& Sabia, 2020, p. 3) The ten-day event in South Dakota drew people from around the country,
with the potential of widespread contagion. The study predicted as many as 266,796 non-
fatal cases, noting that the cost of $12.2 billion was enough to have paid each of the
estimated 462,182 rally attendees $26,553.64 not to attend. (Dave, Friedson, McNichols, &
Sabia, 2020, p. 33)
It has not been possible to obtain official confirmation of the extent of Sturgis-related cases.
Given the lack of “a nationally coordinated contact-tracing strategy, the job of identifying chains
of transmission was left to a patchwork of local and state health departments with varying
approaches, leadership and staffing. (Shammas & Sun, 2020) Since few if any events of this
magnitude have occurred nationally or internationally since the start of the pandemic it “has
drawn intense interest from scientists and health officials, and will likely be studied for years to
come because of its singularity. (Shammas & Sun, 2020)
Researchers at Stanford studied patterns of contagion following 18 rallies held by the President
between June 20 and September 22, 2020. In a preprint, the study found “more than 30,000
incremental confirmed cases of COVID-19. Applying county-specific post-event death rates, we
conclude that the rallies likely led to more than 700 deaths (not necessarily among attendees).
(Bernheim, et al., 2020, p. 1)
Muda of Money: Economic Impact
Goldman Sachs Research which examines market conditions for the multinational investment
firm found that “face masks are associated with significantly better coronavirus outcomes.
(Hatzius, et al., 2020) The study “Face Masks and GDP” reported the impact of virus
containment measures in place in the country through April 2020. The “Effective Lockdown
Index (ELI)a combination of official restrictions and actual social distancing datasubtracted
17% from US GDP between January and April.” (Hatzius, et al., 2020)
14
Compiling domestic and international data and work by Dr. Christopher Leffler of Virginia
Commonwealth University, the brief established a correlation between the timing of mask
mandates and the growth of cases and fatalities.
Given the significance of increased mask usage, the study examined how slowing the pandemic
could avoid further economic damage from new lockdowns. The report concluded, the upshot
of our analysis is that a national face mask mandate could potentially substitute for renewed
lockdowns that would otherwise subtract nearly 5% from GDP.” (Hatzius, et al., 2020)
These findings by Goldman Sachs Research were referenced in a CDC scientific brief, which
noted, increasing universal masking by 15% could prevent the need for lockdowns and reduce
associated losses of up to $1 trillion or about 5% of gross domestic product.” (CDC, 2020)
Muda of Money: Procurement
Several of the wastes typically found in bureaucracies are present in government procurement
primarily waiting and overprocessing. Well-intended policies to fight corruption result in complex
requirements which are particularly problematic during an emergency. The muda in the typical
requirements could be identified, but perhaps not easily removed. Although public managers are
not obligated to accept bids that do not meet the specifications, it is difficult to prepare specs that
anticipate every contingency. Once a vendor is selected, it is equally challenging to manage the
deliverables. The unlean conditions in the procurement process crumpled by necessity under crisis
conditions, giving way to massive muda and mura.
Chaos and abdication
In a global emergency of epic proportions, chaos in the medical product supply chain
exacerbated the pandemic’s impact in human life and in economic cost. During the first wave in
the spring of 2020, states faced a marketplace that was characterized as “the wild west” as they
desperately sought to acquire necessary personal protective equipment (PPE).
Surveys by the Office of Inspector General conducted March 23-27, 2020 found “widespread
shortages of PPE put staff and patients at risk”, and “uncertainty about availability of PPE from
Federal and State sources and noted sharp increases in prices for PPE from some vendors.
(Grimm, 2020, p. 3)
It was a “Hobbesian state of nature” according to Stephen B. Gordon of the Institute for Public
Procurement (NIGP). He explained, “State, local and healthcare organizations were bidding
against other state, local and healthcare organizations and the federal government, too. Not
infrequently, a governmental or healthcare organization has believed it had a contract with a
supplier, only to be out-bid by another organization at the last minute (Gordon, 2020). Fraud
was a serious risk in such conditions involving dishonest brokers who would not be considered
15
in normal timesentities and institutions have payed enormous sums of money to fraudulent
suppliers, only to receive shoddy items or nothing in return.” (Gordon, 2020)
Dr. Andrew Artenstein recounted a harrowing experience attempting to acquire PPE for Baystate
Hospital. In a letter posted on NEJM.org on April 17, 2020, he explained, “Our supply-chain
group has worked around the clockDeals, some bizarre and convoluted, and many involving
large sums of money, have dissolved at the last minute when we were outbid or outmuscled,
sometimes by the federal government.” (Artenstein, 2020) He described a scenario: “Having
acquired the requisite funds more than five times the amount we would normally pay for a
similar shipment, but still less than what was being requested by other brokers we set the plan
in motion.Dr. Artenstein and his team arrived at “a small airport near an industrial warehouse
in the mid-Atlantic region.” They planned to use “two semi-trailer trucks, cleverly marked as
food-service vehicles” that “would take two distinct routes back to Massachusetts to minimize
the chances that their contents would be detained or redirected”. When two FBI agents arrived to
make sure it was not a black-market operation, Dr. Artenstein presented his credentials to
confirm that the supplies were headed to a hospital in urgent need. (Artenstein, 2020)
After a shipment of three million N95 masks bound for Massachusetts was confiscated at a port
in New York, Governor Charlie Baker collaborated with New England Patriot’s owner Robert
Kraft to bring a new order from China on the team’s private plane. (Rose, 2020) States were not
the only entities trying to help mitigate the crisis. Actor Sean Penn’s non-profit, CORE, set up
free drive-thru testing sites. (Columbia Broadcasting System, 2020)
Lean practitioner Beau Keyte noted, “The good news is that there was incredible ingenuity that
created workarounds to counter the lack of national organization and support: citizens sewed
masks, engineers repurposed other equipment to make ventilators, hospitals and universities
created their own testing kits and capabilities. But we shouldn’t confuse this with a well laid-out
plan: this was a reaction of a nation forced to respond as it had more casualties than the next
worst five countries combined in the COVID-19 international war.” (Keyte, 2020)
Fifty states all competing to buy the same items. A huge financial waste and a waste of human
effort by governors, doctors, administrators, and members of the National Guard and state police,
as well as the federal regulators who were chasing the black-market bad actors.
To say it was unlean is an understatement. "If you've got 50 states competing for the same test
kits, we're gonna end up with a s*** show," remarked Lieutenant General Russel Honoré, who
oversaw the military relief efforts in the wake of Hurricane Katrina. (Touchberry, 2020)
Lean seeks to understand the root cause of the problem. Below is an illustration of the 5 Whys
technique. The 5th why will get closer to the root cause and lead to a discussion of the supply
chain.
16
Why was a shipment confiscated by
FEMA? Because it was needed elsewhere.
Why was it needed elsewhere? Because
hospitals in other parts of the country lacked
essential supplies.
Why did they lack supplies? Because they
had not been able to acquire items in the
market.
Why were they unable to buy supplies in the
market….?
Why was a shipment confiscated by the
FBI? Because it was counterfeit or on its
way to the black-market.
Why were governments and hospitals falling
victim to counterfeit supplies, profiteers, and
bad actors? Because they were unable to
acquire items through the regular market
channels.
Why were they unable to buy supplies in the
market….?
A Lean Supply Chain
Practitioners, public administrators, and academics have studied the supply chain challenges.
Each deserve further examination. For the purpose of this paper, I will briefly summarize the
work of two Lean practitioners, Beau Keyte and Robert O. Martichenko.
Robert O. Martichenko of the LeanCor Supply Chain Group defined the current crisis as a ‘Black
Swan’ event: an occurrence of “extreme rarity, severe impact, and the widespread insistence that
the event was obvious in hindsight. That is, we should not be so surprised the event happened
because we had already been warned. (Martichenko, 2020, p. 2) He noted that previously “a
large part of our population believed that pandemics were a medical discussion and not a supply
chain discussion. Now we know differently. (Martichenko, 2020, p. 2)
Acknowledging two separate yet interrelated streams, the corporate supply chain and the public
health supply chain, Martichenko posed a series of questions, notably: How do we create an
effective and reliable ONE TEAM approach to coordinating supply chain efforts during a
healthcare crisis? (Martichenko, 2020, p. 2)
He suggested, “The post-COVID-19 supply chain will need to be a system that is managed with
principles of systems thinking. This will not be an easy task as it will require involving all
aspects of the ecosystem that make up the health crisis response supply chain. This will include
private enterprise, public sector, not-for-profit, academic and volunteer organizations.
(Martichenko, 2020, p. 8)
Any after action review must consider the optimal use of the Strategic National Stockpile (SNS).
Given the dire consequences of being unprepared, it is tempting to advocate for accumulating
adequate inventory for any potential Black Swan event. Such an effort would be unlean
wasteful, expensive, and ultimately ineffective. Since stockpiling cannot anticipate all needs,
Martichenko focuses on the development of surge capacity. He declares, “This competency
needs to be considered a function of national security” essentially “a national core competency.
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(Martichenko, 2020, p. 11) He explains, “The good news is, we know how to do this! We know
how to do this because these are the core principles of lean manufacturing, disciplined supply
chain management, and building cultures of operational excellence. From a supply chain
perspective, the post COVID-19 healthcare supply chain will need to be designed and executed
around fundamental lean and operational excellence principles.” (Martichenko, 2020, p. 13) He
then describes in detail how the ONE SYSTEM-ONE TEAM could be operationalized within the
context of lean principles. (Martichenko, 2020, p. 13-18)
Beau Keyte recommended using a National Supply Chain Coalition to develop routine suppliers
to the SNS. The Stockpile would then be used as a routine supplier to the military as well as
public and private-sector health-care systems across the country.” (Keyte, 2020) This lean
stockpile would avoid the waste of obsolete materials by using public-private market partnership,
with everyone benefiting from economies of scale. He explained, if the mask shelf life is five
years and we produce 20% of the supply each year for the Stockpile, hospitals and others need to
purchase and absorb 20% of the stockpile’s surgical masks each year. The sales should cover the
cost of keeping the stockpile fresh.” (Keyte, 2020)
Keyte’s 5-point plan also uses a team based approach to address the supply chain system failures.
Keyte applies PDCA principles, absent the Lean lingo. Both he and Martichenko (p. 17)
mention the use of simulations, drills, and war games clearly part of the PDCA cycle. Keyte
explained, The critical thinking and learning involved in creating a National Pandemic
Response Coalition, a National Stockpile Supply Chain Coalition and comprehensive pandemic
war games would prepare us for the next national response without the need for political
decisions. (Keyte, 2020)
In a series of interviews in March and April, 2020, General Russel Honoré described the
essential role of the defense logistics command. He objected to the administration’s reliance on
the private market to move supplies which resulted in the bidding wars and suboptimal
allocation. He explained that it is the responsibility of the federal government to supply those
goods during a disaster, not to send it into the commercial market. Rather, the logistics
command would conduct assessment of the anticipated need compared to the stocks on hand in
each state, acquisition from the private market, transport, and distribution. (Honoré, 2020)
Supply Chain Kaizen
A multi-disciplinary team of public and private sector practitioners could be convened to conduct
a series of Lean projects using a range of tools including the 5 Whys and fishbone diagrams for
cause and effect and root cause analysis, value stream mapping, 5S for orderliness, and an A3
problem solving format
4
. The typical A3 has seven fields: background, current condition, goals,
root cause analysis, countermeasures, plan, and sustainment. Its structured format guides users
through a problem-solving logic model.
4
It is named for A-3 sized paper (11’’ x 17”), but it can be on any size.
18
Team composition would be based on each project’s purpose. Given the complexities of public-
private coordination, problem statements would need to be developed to focus the outcome of
each project. For example:
Problem Statement for Kaizen on private sector medical supply chain: How would a lean
supply chain function to get right materials (meets quality specifications) as needed
(timeliness) for a fair price?
Problem Statement for Kaizen on public management of the Strategic National Stockpile:
How can the range of items needed in the federal stockpile be determined? How can the
items be procured? How can the optimal inventory level of each item be managed?
Problem Statement for Kaizen on federal, state, local emergency coordination: How can
an effective response to a national emergency be conducted among multiple
jurisdictions?
While protocols on each of these would have been addressed in plans prepared by previous
administrations, they were not necessarily prepared with a lean lens. Typically, needs are
identified, and money is appropriated. Absent a systematic approach, substantial sums spread
over many jurisdictions can result in redundancy and operational confusion. Lean plans are
designed to minimize rework and cost. Drills to clarify operational protocols would vet the
plans, minimizing the opportunity for second-guessing by politicians. These simulations would
also need to consider the likelihood of malfeasance or nonfeasance by political actors and
develop appropriate countermeasures. This factor is more difficult to lean.
Administrative Capability
The country ironically known as the United States suffered from the lack of a cohesive national
response. As noted by the Editors of the NEJM, “the federal government has largely abandoned
disease control to the states. Governors have varied in their responses, not so much by party as
by competence. But whatever their competence, governors do not have the tools that Washington
controls. Instead of using those tools, the federal government has undermined them.” (Editors,
2020)
The virus was spreading without regard to state lines, but not at the same rate in every
community. A lean response would be based on standard criteria applied to specific conditions
such as population density, positivity rate, and capacity for contact tracing. Optimally, thousands
of jurisdictions apply a standard response under specified circumstances. As Lt. General Russel
Honoré pointed out, “You cannot win a war without focusing your efforts.” (Honoré 2020) The
same is applicable to any emergency.
Enterprise Alignment and Hoshin Kanri
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lean tools and concepts can be applied to the coordination effort. The complexities here require a
separate in-depth inquiry. For the purpose of this paper, a brief overview:
Utah State Universitys Shingo Institute promotes a comprehensive quality model based on the
work of Dr. Shigeo Shingo. The Shingo Model has guiding principles that are divided into
three dimensions, Cultural Enablers, Continuous Improvement and Enterprise Alignment. Each
of the three are important elements in Lean practice. Enterprise Alignment is the most
challenging to achieve in the federal system. The fragmented nature of redundant and competing
jurisdictions are strong countervailing forces.
The objective is to “develop management systems that align work and behaviors with principles
and direction in ways that are simple, comprehensive, actionable, and standardized.Further,
the full potential is realized only when most critical aspects of an enterprise share a common
platform of principles of operational excellence, management systems, and tools. (Shingo
Institute, 2020, p. 35)
Among the essential components is Policy Deployment, also known as Hoshin Kanri. According
to the Shingo Model, “Policy deployment is a planning and implementation system based on
scientific thinking, employee involvement, and respect for the individual. At the strategy level,
policy deployment provides leadership with the necessary principles, systems, and tools to
carefully align key objectives and execution strategies. This empowers the organization, through
cascading levels of detail, to achieve those objectives. Because so many people are involved,
clarity is critical. An aligned strategy helps keep everyone on the same page and pointed in the
same direction.” (Shingo Institute, 2020, p. 35)
Unity of Effort
Unity of Effort (UoE) is not a typical lean tool, but it was included in the State of New
Hampshire’s Lean Black Belt program (2015-2018) by instructor Major Michael Moranti (Ret).
The UoE Framework was designed by the military to conduct operations that were not under a
single chain of command. In these circumstances, success relies on coordination among diverse
actors and stakeholders. UoE is intended “to provide a broad consensus based approach,
comprised of common objectives, applied across different geographic regions. (U.S. DoD,
2013, p. 3) It is a cooperative concept which refers to coordination and communication amongst
agencies toward the same common goals for success; in order to achieve unity of effort.
It is not necessary for all agencies to be controlled under the same command structure (as with
unity of command), but it is necessary for each agency’s efforts to be in harmony with the short-
and long-term goals of the mission. It is based on four principles: (1) Common understanding of
the situation, (2) Common vision, goals and objectives for the mission, (3) Coordination of
efforts to ensure continued coherency, and (4) Common measures of progress and ability to
change course if necessary.
20
Kata
Among the lean tools applicable to the challenge of a global pandemic is a structured problem-
solving technique based on the scientific method. As developed by Mike Rother, Kata combines
a scientific process of inquiry and experimentation with structured routines of deliberative
practice. (Rother, 2010)
This technique is particularly valuable for forming policy based on evolving medical science. Kata
uses a structured approach based the understanding that science is not static. It progresses
through research and experimentation. The methodology is built to incorporate new learning and
to adjust accordingly. As Rother explains, The way from where we are to where we want to be
next is a gray zone full of unforeseeable obstacles, problems, and issue that we can only discover
along the way. The best we can do is to know the approach, the means, we can utilize for dealing
with the unclear path to a new desired condition, not what the content and steps of our actions
the solutions will be. (Rother, 2009, p. 8)
Further Research
I expect that the failures of the administration in power in 2020 will continue to be studied.
Calculations of the full extent of the muda would be complex, potentially unfathomable. While
the scope of nonfeasance and malfeasance by that administration may have been an outlier,
understanding the dynamics of the dysfunction will be instructive.
It will also be valuable to examine the challenges of public administration within the context of
federalism. How does jurisdictional differentiation naturally inhibit a cohesive national
response, and to what degree was the failure in 2020 the product of a uniquely toxic
administration? It is expected that the incoming administration will try to heal the fissures
created by the divisive policies that former Maryland Governor Martin O’Malley characterized
as “Darwinian federalism.” (O’Malley in McCarthy, 2020) That is certainly a topic for study.
Going forward, I believe it is crucial to examine the structure and funding of the administrative
state from a systemic perspective. As Fareed Zakaria pointed out, the erosion of public sector
capacity had been going on for decades. (Zakaria, 2020) Functionality was starved while
complexity was expanded. State-federal functionality should be examined within the context of
overlapping and redundant duties.
Discussion and Recommendations
While the election of 2020 heralded a new administration with a promise to do better, it is
imperative that practitioners and scholars join the conversation of how to do better. Lean thinkers
understand the paradox that our government has been both starved and overgrown. Federal
agencies are understaffed but overburdened with mountains of regulations and politicized
21
mandates and rules. Funding alone cannot fix it. Within the process improvement wheelhouse,
there are tools to address waste and redundancy.
In order to succeed, I see a series of prerequisites: adequate funding, managerial commitment,
workforce training in Lean, and the administrative autonomy to enact improvements. Indeed,
many of the fundamental reforms discussed in this paper could not take place without public
managers exercising their professional judgement. Therefore, I recommend that the study of
Lean management be part of masters’ programs in both public administration and public health
(MPA and MPH).
Much can be learned by examining what works. There are states, counties, municipalities, and
federal agencies that have initiated Lean programs. Concrete gains are being made through
persistent practice as lean thinking is internalized throughout the organization. It fuels
organizational purpose, enabling the redeployment of previously wasted capacity to mission.
These public sector Lean programs deserve attention by academic researchers.
Reflections
A promising, pragmatic message was offered by Josh Howell of the Lean Enterprise Institute as
the crisis unfolded in March 2020. He reflected, “Thankfully, lean thinking gives us
a powerful way to address problems of any size. It focuses us on what matters: purpose (the
value to create), process (even when, or I should say especially when, it must change), and
people (be thankful or your team!). It guides us though figuring things out and continuously
improving, with structured cycles of Plan-Do-Check-Act. (Howell, 2020)
It may seem impractical to advocate the adoption of Lean management in public service. There
are layers of jurisdictions, redundant functions with overlapping authority, uneven funding
streams, appropriation muddles, and political interests. Perhaps it is naïve. But we need to start
somewhere. As Lean trainer Sam McKeeman reminded his classes: “What’s the best time to
plant an oak tree? 20 years ago. What’s the second-best time? Now. (McKeeman in McGovern,
2019, p. 175)
Much of the pandemic response in 2020 brought Deming’s challenging quote to mind: “It is not
necessary to change. Survival is not mandatory.” (W. Edwards Deming Institute) Looking ahead
to 2021, we can move forward learning from what has been tried and continuously striving to
improve.
22
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