This article compares April’s federal guidance for recording the cause of death that may be due to the COVID-19 virus to assessments of the cause of death listed on the death certificates of patients infected with a multidrug-resistant organism or “superbug.”
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Highlights
- Questions are raised about the validity of the CDC’s April 2020 guidance for certifying deaths due to COVID-19
- A federal policy that sanctions certifying a person as dying from a pathogen without confirming that the decedent was infected with the pathogen (using a reliable, validated laboratory or rapid diagnostic test) is also questioned
- The standards and methods that federal health officials use today to assess whether the COVID-19 virus contributed to a person’s death were found to differ starkly from the practices and assessments federal and state health officials routinely use to evaluate whether a multidrug-resistant bacterial infection played a role in a patient’s death
- Efforts by public health officials to assess the cause of death in patients infected with multidrug-resistant bacteria using methods that are more on par with those the CDC uses to certify COVID-19 deaths appears justified and is recommended
- Assessments by health officials of the cause of deaths associated with multidrug-resistant bacterial infections, COVID-19 and the influenza (“flu”) virus are compared and discussed
- Published reviews of death certificates reveal that they often omit listing the multidrug-resistant infection in patients confirmed to be infected with the deadly organism at the time of death, in general contrast to deaths related to COVID-19
- Validation of death certificate data associated with the COVID-19 disease to ensure accuracy and quality and to prevent the miscounting of actual COVID-19 deaths is suggested
- An accurate accounting of the number of deaths due to the virus, particularly mortality trending over time, is important to identifying and implementing effective, validated strategies and mitigations designed to prevent additional COVID infections and deaths
- This article recognizes and appreciates that assessments of the cause of death of a patient infected with a superbug, the COVID-19 virus, or another pathogen can be complicated particularly in the presence of pre-existing underlying health conditions
August 20, 2020 (updated Sept. 11, 2020) (By Lawrence F Muscarella, PhD) — The standards and methods the Centers for Disease Control and Prevention use to assess the role the COVID-19 virus may have played in a person’s death stands in stark contrast to the practices and assessments federal health officials routinely use to evaluate the potential contribution of a multidrug-resistant bacterial infection to a patient’s death, recent research has found.
Whether the different policies the CDC uses for COVID-19 compared to multidrug-resistant organisms are based on valid public health principles is a possible consideration that warrants further discussion.
For background, the CDC published guidance in April for certifying deaths due to SARS-CoV-2 infection. This federal document may be as notable for its instructions and advice to death certifiers as for its definition and classification of a COVID-19 case.
While advising that “testing for COVID–19 should be conducted whenever possible,” the CDC’s guidance does not require, as a precondition, that testing be performed to confirm infection prior to reporting COVID–19 on a death certificate. The severe acute respiratory syndrome coronavirus 2 virus causes COVID-19 disease.
More specifically, the CDC advises that “it is acceptable to report COVID-19 on a death certificate,” without having necessarily performed confirmatory testing, “if the circumstances are compelling within a reasonable degree of certainty.” This advice can introduce subjectivity into the data, however, and result in a death certificate that is in error, as one physician’s assessment of what defines a reasonable degree of certainty may not be consistent with or align with another’s.
The CDC classifies COVID-19 cases as confirmed, probable or suspected based on clinical criteria, laboratory evidence and epidemiologic linkage. Of these three categories, only a confirmed case “meets confirmatory laboratory evidence” (i.e., detection of SARS-CoV-2 RNA in a clinical or autopsy specimen using a molecular amplification test).
To help further explain these three case categories, this CDC’s April (2020) guidance includes an appendix with three practical examples of death certifications, or cause-of-death statements.
One of the appendix’s examples details the death of an 86-year-old woman with an unconfirmed case of COVID-19 disease. Testing to verify infection was not performed, although the coroner concluded that “given the patient’s symptoms and exposure to an infected individual,” the likely underlying cause of death was COVID–19.
Cases that do not include testing to confirm infection, however (i.e., suspect and probable cases), are not confirmed cases, which can introduce the possibility (if not the likelihood, at least in some cases) of a certifier, even while adhering strictly to the CDC’s April guidance, recording COVID-19 on the death certificate of a decedent not infected with the virus — an unconventional practice that provides opportunities for error and the miscounting the actual number of deaths known to have been caused by COVID-19.
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“Probable” or “presumed” infection
The CDC’s April guidance further advises that if a case cannot be definitely diagnosed but the disease is “suspected or likely (e.g., the circumstances are compelling within a reasonable degree of certainty),” as in the case of the aforementioned 86-year-old woman, COVID–19 may be reported on the death certificate (as “probable” or “presumed”).
Though subject to potential counting errors, the CDC’s guidance again adds a similar caveat that, in such instances, “certifiers should use their best clinical judgement in determining if a COVID–19 infection was likely.”
This advice is consistent with a presentation the CDC posted on-line the same month discussing deaths related to COVID-19. During the webinar, the CDC stated it encourages use of the words “probable” and “likely” when testing for the virus is not available.
The CDC affirmed during this presentation, however, that it is not concerned that writing “probable” or “presumed” on a death certificate could result in the “overcounting the number of deaths.” (It is recognized that other CDC guidance too may permit listing a condition as “probable” even if it has not been definitively diagnosed.)
Clarifying whether the health agency might “count” a probable (or unconfirmed) case as a true, definitive COVID-19 infection, a CDC representative stated during this same webinar that, “If you’re pretty sure that it was a COVID-19 infection and you’ve written probable COVID-19, I don’t think that there’s necessarily a need to amend the death certificate. And, of course, you may do that if you like.”
Virtually eliminating any doubt, this CDC representative clarified during the webinar that “in a case of probable COVID-19 we will count it as COVID-19” (link since removed).
It is reasonable to ask whether “superbug” infections are receiving sufficient attention from federal health officials. Comparisons of the methods they use to assess and assign deaths to COVID-19, compared to multidrug-resistant organisms, yield stark differences. Whether these differences are based on important public health principles is a possible consideration warranting further discussion. — Lawrence F. Muscarella Ph.D.
The potential for misclassifying cases notwithstanding, a death certificate’s accurate recording of the cause of death that may be related to an infection — whether caused by COVID-19, a multidrug-resistant organism, or another infectious agent — or, alternatively, a death that may be due to a preexisting condition or comorbidity such as diabetes, is integral to sound estimates of the pathogen’s (or comorbidity’s) mortality rate and public health threat, to the appropriate allocation of limited resources, and to the identification and implementation of effective strategies and mitigations designed to prevent additional infections.
For instance, an increase or spike in a pathogen’s mortality rate might prompt federal or local health officials to adopt more robust measures to improve public safety, while a decline in this rate might cause the easing or removal of imposed precautions. These actions taken in response to the infection numbers can only be as valid and justified as the mortality data are sound and reliable.
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Superbug-associated deaths
Multidrug-resistant organisms — or “superbugs” — are another public health scourge. For perspective, while the COVID-19 death rate has been estimated to be less than 1%, the U.S. mortality rate for some superbug infections, such as bloodstream infections caused by CRE bacteria or the fungus Candida auris, is significantly higher and can even exceed 50%.
A peer-reviewed report in 2018 re-estimated the number of deaths in the U.S. in 2010 due to a superbug infection to be as high as 162,000, which is not starkly different from the number of deaths in the U.S. attributed to the COVID-19 disease reported to date.
In today’s clinical settings, COVID-19 and serious bacterial infections can overlap and become clinically intertwined. A study published in Lancet reporting on the deaths of 54 hospitalized patients with laboratory-confirmed COVID-19 found that half (n=27) experienced a secondary infection, such as ventilator-associated pneumonia. Fifty three of these patients (98%) received antibiotics and 12 (22%) received antivirals.
Superbugs are microorganisms that have developed resistance to several types of antibiotics. Carbapenem-resistant Enterobacterales, as they name reveals, are resistant to “last resort” carbapenem antibiotics.
Antimicrobial resistance
Underscoring the dangers and epidemiology of superbugs, U.S. federal health officials reported earlier this year that “antibiotic resistance is one of the biggest public health challenges of our time.”
Last year, referring to antimicrobial resistance, a United Kingdom public health representative warned about “a danger to humanity” that is “as big a danger as climate change or warfare.”
Also last year, the CDC stated in a report discussing certain superbugs as “urgent threats” that the agency “has taken aggressive action,” in coordination with other stakeholders including state and local health departments, “to rapidly detect, prevent spread, and innovate against antibiotic resistance.”
In May, a former director of a CDC division warned that superbugs could be another “hidden danger” of COVID-19. A September news report quoted the biosecurity research director at Australia’s national science agency as saying “Covid is not anywhere near the potential impact” of antimicrobial resistance.
And, last year the World Health Organization concluded that if no action is taken, “drug-resistant diseases could cause 10 million deaths each year by 2050.”
Different standards? COVID-19 vs. Superbugs
The CDC’s April guidance for recording the cause of deaths related to the COVID-19 was reviewed and its policies and criteria compared to the standards and practices the CDC have used to assess the cause of death of patients infected with a bacterial or fungal superbug.
Several publications were reviewed in addition to the CDC’s COVID-19 guidance, including several superbug outbreak investigations, other federal guidelines, state guidance documents, news reports, and other relevant sources.
Federal and state guidance for reporting cases and deaths that could be due to the influenza virus, which causes “the flu” in humans, was also reviewed for perspective and additional insight.
Need guidance investigating the cause (and prevention) of a healthcare-associated infection or outbreak? LFM-Healthcare Solutions, LLC provides medical expertise for legal representatives, device manufacturers, and medical facilities specializing in the causes and prevention of healthcare-associated infections linked to contaminated reusable medical equipment.
This review found that the standards and methods the CDC’s April guidance uses to assess whether the COVID-19 virus played in a person’s death differ starkly, in some important respects, from the practices and assessments federal health officials routinely use to evaluate the potential contribution of a multidrug-resistant bacterial infection to a patient’s death.
Example 1: Establishing a comparatively low watermark for causality, the CDC’s April guidance advises that COVID-19 be specified on the death certificate if it “played a role in the death.” In contrast, however, health officials investigating a superbug outbreak in Illinois, in 2013, that was linked to reusable medical equipment, like several other reviewed cases, appear to apply a different, more stringent, standard of proof.
Namely, health officials that included CDC investigators reported that these patient deaths in Illinois “did not appear” to be related to the superbug infection, adding that that it could not be said “whether the bacteria had contributed to any deaths” and that “no one had died as a direct result of infection or exposure” — this, despite the documented high mortality rate associated with this outbreak’s CRE superbug.
The mortality rate of infections caused by this outbreak’s multidrug-resistant organism can be as high as 40%-50%. Previously noted and provided again for perspective, the COVID-19 death rate has been estimated to be less than 1%.
Example 2: Investigating a separate superbug outbreak that occurred in Washington around the same time and that was also linked to reusable medical equipment, the CDC along with other health officials again provided an uncertain assessment of the cause of patient death, observing that “[b]ecause affected patients all had severe underlying disease, the role of the outbreak strain in patient deaths cannot be determined.”
Example 3: In another case involving four deaths linked to C. auris, health officials including CDC investigators similarly provided an opaque assessment of the cause of patient death, telling a news source that “it’s not clear if the deaths were due to the (fungal) infection or the patients’ underlying health conditions.”
Example 4: Investigating a second fungal case, CDC and state health officials reported in 2020 the deaths of three patients in New York infected with pan-resistant C. auris. Once again appearing to apply a starkly different burden and standard for causality than the CDC advises in its April guidance for COVID-19, the CDC reported that, for two of these three patients, “the role of C. auris in their deaths is unclear.”
The CDC reported that the third patient infected with this deadly C. auris found to be resistant to all three classes of commonly prescribed antifungal drugs “died from underlying medical conditions,” apparently ruling out the pan-resistant superbug as playing any contributory role in the patient’s death.
These CDC’s assessments of the cause of the three deaths notwithstanding, studies estimate the crude in-hospital mortality rate for C. auris candidemia to range from 30% to 72%.
Example 5: FDA issued an alert in 2021 to raise awareness among health care providers about the risk of infections, including those caused by bacterial superbugs, associated with “reprocessed” urological endoscopes, including cystoscopes.
This alert states that FDA has received reports since 2017 linking patient infections to these devices. Three of these FDA reports, the alert stated, describe the death of three patients who developed Pseudomonas aeruginosa infections following exposure to a urological endoscope.
Like the suggestions by health officials in the previous four examples that the contribution of the bacterial infection to patient death could not be determined or was otherwise unclear (e.g., because of underlying health conditions), this 2021 FDA alert stated that it is “unknown whether or to what degree the reported infections contributed to the patient deaths, and patient co-morbidities may have been a factor.”
In summary, none of the reviewed superbug outbreak investigations conducted by federal health officials reported that the multidrug-resistant organism (or P. aeruginosa infection, in the case of the 2021 FDA alert) caused or directly contributed to patient death.
Whether the assessments of the cause of death by CDC and other health officials in these reviewed superbug cases are anomalistic, or instead reflective of a common practice is unclear. Nevertheless, that federal health officials appear often to downplay the potential contribution of a deadly superbug to patient death, in contrast to the low-bar standards the CDC applies to COVID-19, can be confusing to explain.
Comorbidities
That a comorbidity may hinder, interfere with, or even obscure a clinical assessment or determination of the role a superbug played in the death of infected patients is recognized, particularly in the context of today’s pandemic when certifying and recording the COVID-19 disease as a cause of death has become common in patients with comorbidities.
As reported in the aforementioned March Lancet study, two thirds of the COVID-19 patients who died were diagnosed with a comorbidity, 26 of them (48%) with hypertension.
The same month, the CDC reported that approximately 90% of hospitalized patients identified through a COVID-19 surveillance network “had one or more underlying conditions.” In updated August findings, the CDC reported that 94% of the individuals in the U.S. who died of COVID-19 had at least one pre-existing condition, such as obesity or heart disease.
Nevertheless, a review of several reports suggests that the presence of a comorbidity may more often prevent federal health officials from assigning a superbug infection as a cause of death than a COVID-19 infection.
While there may be sound rationale for applying one set of standards to COVID-19 and another, more robust set to multidrug-resistant organism when certifying related infection deaths, the reasons are not self-evident, arguing for clarity through discussion and debate.
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The following set of three peer-reviewed articles by Dr. Muscarella (and in one case, a co-author) may be the most comprehensive and historical collection published to date discussing associations between deadly superbugs and reusable medical equipment:
(1) Muscarella LF. Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes. BMJ Open Gastroenterol 2019 Aug 5;6(1):e000282. || (2) Mehta AC, Muscarella LF. Related “Superbug” Infections. Chest 2019 Aug 14;pii:S0012-3692(19)31457-6. || (3) Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy. World J Gastrointest Endosc 2014 Oct 16;6(10):457-74.
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Flu-associated deaths
It is not only assessments by health officials of the cause of death for superbug-infected patients that appear to employ a different standard or measure than the CDC’s April guidance for recording deaths that could be due to COVID-19.
For instance, some of the criteria the CDC and state health departments use for defining cases and reporting deaths associated with the influenza viruses appear, too, to differ substantively, in terms of the testing requirements to confirm infection, from the CDC’s April COVID-19 guidance.
For pediatric patients, the CDC defines an influenza-associated death (for surveillance purposes) as “a death resulting from a clinically compatible illness that was confirmed to be influenza by an appropriate laboratory or rapid diagnostic test.”
This CDC definition elaborates that there “should be no period of complete recovery between the illness and death,” and that influenza-associated deaths “in all persons aged <18 years should be reported.” (While flu-associated deaths in children are nationally notifiable, states are not required to report to the CDC adult deaths related to influenza infection.)
Re-emphasizing the importance of testing to confirm infection, this CDC guidance on influenza-associated pediatric mortality clarifies that a death should not be reported if (among other exclusionary criteria) there is “no laboratory confirmation of influenza virus infection.”
As a primary goal, the intent of this criterion is to reduce, if not eliminate, the potential for subjectivity, false-positive assessments of infection, and miscounting.
However, in contrast to this CDC case definition for influenza-associated pediatric mortality, which includes only confirmed cases of infection, the CDC’s case classification for COVID-19, as noted previously, also includes suspect and probable cases, both of which lack confirmatory laboratory evidence.
Influenza infection can range from asymptomatic illness to viral pneumonia and death. The seasonal “flu” is caused by influenza A and B viruses, and like COVID-19, it is a contagious respiratory illness. While there are important differences between the viruses, both influenza and SARS-CoV-2 may be transmitted by contact, droplets and fomites.
Also addressing a confirmatory testing requirement in the context of the influenza virus, the CDC advises in an on-line document that infection “cannot be diagnosed accurately based on signs and symptoms alone. Laboratory testing is necessary to confirm the diagnosis.” Adding an important detail, this CDC document maintains that “individual cases of influenza cannot be distinguished from other respiratory virus infections based on clinical information alone.”
Affirming the importance of confirmatory testing in the context of deaths possibly related to influenza, states in the U.S., similar to the CDC’s pediatric mortality guidance, may require laboratory testing to confirm infection.
For instance, the Washington State Department of Health advises that “[o]nly lab-confirmed fatal cases are reportable.” According to this state’s reporting policies (which do not appear to distinguish between pediatric and adult cases), the purpose of reporting and surveillance of (laboratory confirmed) influenza-associated deaths is, in part, to determine mortality rates and to “detect emerging threats such as avian and other novel influenza strains.”
Similarly, the North Carolina Department of Health and Human Services advises that, for both adult and pediatric cases, all influenza-associated deaths “are reportable to the Local Health Department. An influenza-associated death is defined for surveillance purposes as a death resulting from a clinically compatible illness that was confirmed to be influenza (any strain) by an appropriate laboratory or rapid diagnostic test.”
This state health department emphasizes that, among other exclusion criteria, a “death should not be reported” if there is “no laboratory or rapid test confirmation of influenza virus infection.” Unlike flu deaths in adults, COVID-19 is a nationally notifiable disease.
In summary, unlike the CDC’s April guidance for certifying deaths due to COVID-19, certain state and federal guidance instructs that a death be reported only if testing has been performed to confirm influenza virus infection. Whether there is sound rationale for the CDC’s policy for certifying COVID-19 deaths to differ from certain state and federal policies for reporting influenza-associated deaths warrants further discussion.
Expert Scientific Advisor: LFM-Healthcare Solutions, LLC provides medical expertise and guidance for healthcare facilities (hospitals), device manufacturers and legal representatives of the public, specializing in medical device designs and both the causes and prevention of healthcare-associated infections linked to reusable medical equipment.
Data validation
Validation can be a critical tool for confirming the quality of healthcare safety data. According to the CDC, validation is “double-checking, or confirming” the accuracy and completeness of reportable infection data. Central line-associated bloodstream infections are reportable data that have been validated for years to assess accuracy and the potential for inadvertent reporting bias.
Infection data can be validated using different methodologies (e.g., “external validation”). In 2012 the CDC published guidance for the validation of central line-associated bloodstream infections in intensive care units.
A 2017 inspector general report states that “accurate data are fundamental to the integrity of the (Centers for Medicare and Medicaid Services’) quality-based payment programs,” adding that the reporting of imprecise data could affect payment accuracy.
Validation of death certificate data associated with the COVID-19 disease is also important to ensure the data’s quality and integrity. Death certificates state a certifier’s medical opinion and therefore can have mistakes — for example, listing a pathogen like COVID-19 as the cause of death of a decedent who was neither tested for nor infected with the pathogen.
Such validation is a type of “data auditing” that might reasonably involve reviewing a statistically reliable and randomly selected sample of patient medical records (or autopsy findings) and comparing the findings with the associated death certificate documentation and data to evaluate their consistency with one another. Other data validation model types could also be used.
Highlighting the importance of data validation, the CDC has published that medical record reviews are needed to “elucidate more information for decedents with only COVID-19 listed on their death certificate or those that could not be plausibly categorized as attributable to COVID-19 based on death certificate data alone.”
CONCLUSIONS and SUMMARY
The standards and methods the CDC’s April 2020 guidance use to certify and record the COVID-19 virus as the cause of death differ starkly from the practices and assessments the CDC routinely use to evaluate whether a multidrug-resistant bacterial infection contributed to a patient’s death, this review found.
Efforts by public health officials to assess the cause of death in patients infected with multidrug-resistant bacteria using methods that are more on par with those the CDC uses to certify COVID-19 deaths appears justified and is recommended
For instance, the CDC’s April guidance establishes a standard of inclusivity that sanctions the recording of COVID-19 on a descendant’s death certificate if it “played a role in the death,” is “assumed to have caused or contributed to death,” or is “presumed” to be at fault.
In contrast, however, reviewed evidence suggests that the policies and procedures that federal (and state) health officials often adopt to assess the cause of death in a patient infected with a multidrug-resistant organism apply a narrower, more restrictive standard or proof of causality, with health officials often reporting that an infected patient’s death “was not necessarily attributable” to the superbug infection, the superbug infection’s role in death was “unclear,” or the infected patient’s death was due to underlying medical conditions, not the multidrug-resistant organism.
Despite the relatively high mortality rates of superbugs, which can exceed 50%, none of the randomly selected outbreak investigations reviewed for this article reported the multidrug-resistant organism to be a cause of, or to have contributed to, an infected patient’s death.
That a comorbidity may on occasion potentially hinder or interfere with clinical assessments of the role a pathogen may have played in an infected patient’s death is acknowledged, particularly in today’s context of certifying and recording COVID-19 as a cause of death in patients with comorbidities.
Yet, it is not clear why the presence of a comorbidity would seem to interfere significantly more with a determination that an infection caused by a multidrug-resistant organism may have contributed to a patient’s death than a COVID-19 infection.
Moreover, lacking the requirement that confirmatory testing be performed, it therefore becomes plausible that, in some cases, adherence to the CDC’s April guidance could introduce unwanted subjectivity, error, and result in recording COVID-19 on the death certificate of a decedent not infected with the virus.
Published reviews of death certificates reveal not only that a multidrug-resistant infection is not ordinarily recorded on the death certificate of an uninfected decedent, but that a superbug infection, in apparent contrast to a COVID-19 infection, is often omitted from the death certificate, as possibly playing a contributing role, of a patient confirmed to be infected with the multidrug-resistant organism at the time of death.
Also suggesting different rules for different pathogens, public health definitions and requirements in the U.S. for reporting an influenza-associated death require confirmation of influenza virus infection using an appropriate laboratory or rapid diagnostic test. As noted, however, the CDC’s April guidance does not require confirmatory testing to record COVID-19 as a cause of death.
If the criteria and policies for reporting and recording the cause of death of a patient infected with other types of pathogens such as a superbug were to mimic more closely the guidance the CDC applies today to COVID-19 — for example, specifying the presence of a multidrug-resistant infection on the death certificate as long as the organism “played a role” in death — the impact on healthcare and infection prevention could be significant, possibly with the number of recorded deaths due to a multidrug-resistant organism increasing significantly. (In 2016, a California state senator introduced a bill that would require clinicians to record antibiotic-resistant infections on death certificates if the superbug “played a role in the death,” the Los Angeles Times reported at that time.)
To improve the accuracy and completeness of the infection death reporting, validation of the data — for example, reviewing a statistically reliable and randomly selected sample of patient medical records (or autopsy findings) and comparing the findings to death certificate data — is recommended for consideration.
In closing, this article discusses and compares assessments of the cause of death associated with superbugs, COVID-19 and influenza (understanding, however, that there are important differences between bacteria and viruses). Enhanced efforts to standardize the methods used to count infections and to improve surveillance for antibiotic resistance and to advance public awareness about superbug infections, particularly during today’s COVID-19 pandemic, are recommended to understand with greater accuracy the impact, mortality and costs of primary and secondary superbug-related infections in patients with and without underlying medical conditions.
LIMITATIONS, COMMENTS: This article has several limitations.
- This article’s selection and review of several superbug outbreak investigations could have inadvertently introduced publication bias, resulting in misleading or inaccurate conclusions.
- It is recognized and appreciated that: (a) assessments of the cause of death of a patient infected with a superbug, the COVID-19 virus, or another pathogen can be complicated and more challenging in the presence of pre-existing underlying health conditions; and (b)the circumstances surrounding the discussed superbug cases may be significantly different in important respects than the cases discussing COVID-19 and influenza, which might, in some conceivable way, justify the application of different standards for assessing the cause of death based on the pathogen type. The characteristics of infections caused by bacteria and viruses can be markedly different from those caused by virus like COVID-19. Nevertheless, a diagnosis of infection would ideally be performed by a physician specializing in infectious diseases, and the number of deaths attributed to an infection be based on the patient’s medical records, not solely the death certificate.
- An association between an infection and the use of medical equipment does not indicate the equipment caused the infection.
- The rationale for the CDC’s April COVID-19 guidance not requiring testing be performed to confirm infection was not determined.
- The justification for this federal guidance on certifying deaths related to COVID-19 to appear to differ starkly, in certain respects, from the practices and standards health officials routinely use to assess the role that a superbug infection may have played in a patient’s death also was not investigated.
- The percentage of recorded deaths attributed to COVID-19 that may have been due instead to a comorbidity (and/or an uninfected person) could not be evaluated or approximated.
- Also not studied were the clinical and diagnostic similarities and differences between COVID-19 and the influenza viruses (the latter of which are not coronaviruses), or the impact that implementation of data validation might have on published mortality rates for either COVID-19 or superbug-related infections.
Article by: Lawrence F Muscarella, PhD. Posted August 2020. Copyright (2020). LFM Healthcare Solutions, LLC. All rights reserved. Dr. Muscarella is the president of LFM Healthcare Solutions, LLC, an independent quality improvement company. Click here for more details about his quality improvement healthcare services.
Contact — Contact Dr. Muscarella for a prompt response at: LArry@LFM-HCS.com
Case Reviews, Expert “On-Call” Consulting Services: LFM-Healthcare Solutions, LLC provides medical expertise and guidance for healthcare facilities (hospitals), device manufacturers and legal representatives of the public, specializing in the causes and prevention of healthcare-associated infections linked to medical equipment.