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Ppeconcerns@cdc.gov. End Further Info End Preamble Start Supplemental Information NIOSH published a notice requesting public input and potential participation in a nationwide deployment program for elastomeric half mask respirators in healthcare settings and first responder organizations in the Federal Register on September 14, 2020 (85 FR 56618). This notice announces the extension of the comment period until December 14, 2020. Start Signature John J. Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services.

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What are the key http://closelyknitphotography.com/blog/ features of hospitals that consistently deliver safe care drug card for lasix on labour and delivery?. This is the primary question posed by Liberati and colleagues in this issue drug card for lasix of BMJ Quality &. Safety.1 The authors propose a framework distilled from observations on a group of high-performing units in the UK participating in a training activity to improve patient safety.

This study combined ethnography with individual interviews and focus groups and involved drug card for lasix over 400 hours of total observations at six different maternity care sites. The seven features in their resulting For Us framework correspond well to existing theoretical as well as applied quality improvement strategies. While we agree that their framework describes features that every labour and delivery unit should strive to include, this approach drug card for lasix has some limitations in terms of generalisability.

Specifically, Liberati and colleagues studied maternity units that are high performing, but their sample included only large-volume hospitals in what appear to be well-resourced settings. What is potentially missing is observations on underperforming units, and how these findings may or may not apply to smaller, drug card for lasix lower resourced settings. Additionally, the structure of the UK’s National Health Service (NHS) also limits generalisability.

For example, drug card for lasix this is most analogous to employed physician models in the USA, with the potential advantage of a more organisationally oriented provider workforce. Given that most US hospitals do not have an employed provider model, we can’t assume that these factors will have the same impact in other models of care.In the USA, the Agency for Healthcare Research and Quality (AHRQ) developed a Culture of Safety framework that delineates four key features. (1) organisations recognise that their primary activities are inherently high risk and make it their goal to operate in drug card for lasix a reliably safe manner.

(2) organisations create a safe and drug card for lasix blame-free reporting environment. (3) interdisciplinary and interprofessional collaboration is encouraged to address safety problems. And (4) resources are deliberately allocated and made available to address safety.2 This framework, as does For Us, focuses on a healthcare-oriented conceptualisation drug card for lasix of safety and quality, and details medical outcomes as the primary metrics by which to measure success.

Although achievement of these medical quality outcomes is imperative, we propose that there are additional domains needed to provide safe intrapartum care. (A) prioritising patient experience—including emotional safety, birthing with drug card for lasix dignity and an expectation of person-centred care. And (B) a unit culture that values low intervention births.

Let us consider these domains in more depth.Patient experience and safety are inextricable drug card for lasix. While much work has been done to improve physician–patient communication,3 4 few have successfully targeted the perpetuation of dysfunctional behaviours grounded in healthcare professionals’ implicit and explicit biases.5 This may be in part due to the tendency to observe and look for answers from the standpoint of the healthcare system rather than patients. Women who had recently given birth were included in the study of Liberati and colleagues, but represented only 8 of 65 individual stakeholder interviews, and were not included in focus drug card for lasix groups.

The framework thus describes a high-functioning system from primarily the healthcare drug card for lasix system’s perspective. In general, the patient’s role in achieving safe care includes many aspects, including providing personal information to reach the correct diagnosis, providing their values and lived experience in shared decision-making discussions, choosing their provider such that their needs regarding provider experience and safe practice are met, making sure that they receive the recommended treatments in a timely manner, as well as identifying and reporting errors.6 The detriment to health outcomes among patients who have failed interactions with providers is well documented (eg, leaving against medical advice or experiencing disrespect during their care) while other harms, such as psychological trauma, often go unmeasured.7Emotional and psychological trauma are safety errors, whether or not a patient leaves the hospital physically intact.8 Research has shown that patients experience psychological trauma both as a result of an adverse outcome and as a result of how the incident was managed. In birth, patients conceptualise the meaning of safety very differently from that of the medical system, with physical and emotional safety being inextricably interwoven into a single concept.9 Psychological trauma may manifest in postpartum depression, post-traumatic drug card for lasix stress disorder10 and, some studies suggest, reduced childbearing in patients who experience traumatic birth.11 The experience of emotional safety on the part of the patient is only knowable to the patient, and only addressable when health systems—and health services research—ask the appropriate questions.

Therefore, patient-reported experience measures and critical examination of the process of patient-centred care should be at the centre of quality improvement.High-performing units prioritise patient voice and patient experience as a part of their culture. In a recent article, Morton and Simkin12 delineate steps to promote respectful maternity care in drug card for lasix institutions, including obtaining unit commitment to respectful care, implementing training programmes to support respectful care as the norm and, finally, instituting respectful treatment of healthcare staff and clinicians by administrators and leaders—in other words, a unit culture of mutual respect and care among the entire team enables respectful care of the patient. Liberati and colleagues address the issue of hierarchies on labour and delivery, making the key observation that high-performing units create hierarchies around expertise rather than formal titles or disciplinary silos.

However, this power differential applies drug card for lasix to patients as well. The existing hierarchy on most labour units places physicians at the top and patients at the bottom, which often acts to silence patients’ voices.13 Implicit bias and interpersonal racism and sexism contribute to this cycle of silence and mistreatment on labour and delivery units.14 Disrespect and dismissal of patient concerns have been increasingly described, but still lack quantitative measurement in association with maternal and child health outcomes.15 Interventions aimed at harm reduction are emerging,16 but more work is desperately needed in this area.Valuing low intervention is an important dimension of safety. Safety culture, as it is conceptualised by AHRQ and the current study, is ideally created to prevent or respond drug card for lasix to harmful safety lapses.

This model is more difficult to apply to an environment where the goal is safe facilitation of a normal biological process. In this setting, interventions drug card for lasix (that often beget more interventions) can increase complications. High rates of primary and repeat caesarean deliveries, and other invasive obstetric interventions seen in many birthing units are now widely acknowledged drug card for lasix to be overused and overuse constitutes a patient safety risk.17 In our work in California, we have been able to demonstrate that provider attitudes, beliefs and unit culture can drive caesarean delivery overuse in ways that do not contribute to patient safety.18 19 Each intervention needs to be carefully and jointly considered for value and safety.

This in no way diminishes the life-saving nature of caesarean delivery when it is medically indicated, but it sets up the expectation that safety measures, processes and procedures must be in place to actively work towards supporting vaginal birth rather than treating each labour as an emergency waiting to happen. The striking variation in obstetric drug card for lasix intervention rates among hospitals and providers can provide critical insights. So, what is the right balance of intervention rates and mother/baby safety outcomes?.

In many instances, this may be a false drug card for lasix dichotomy. In a study of California hospital labour practices, Lundsberg et al found that hospitals that prioritised low labour interventions and actively supported vaginal birth (eg, delaying admission until active labour onset, use of doulas, intermittent auscultation of fetal heart tones, non-pharmacological pain relief, and so on) had reduced caesarean delivery rates with well-preserved neonatal outcomes.20 It should be noted that in the USA, rates of intervention are starting at a high level so there is less danger of harm from achieving too low a rate. This may not be the case in the UK where there are now formal inquiries examining obstetric care in multiple NHS hospital trusts where poor perinatal drug card for lasix outcomes have been linked to a systematic aversion to medical interventions even when indicated.21 Getting this balance right has been referred to as the Goldilocks quandary.

Doing too little, too much or just right?. 22In conclusion, drug card for lasix physical safety is the bare minimum of what should be expected in childbirth. Patients have a right, and healthcare providers and systems have an obligation to aim higher, to ensure patients emerge from childbirth as healthy or healthier—both physically and psychologically—than before entering the hospital.

This can be best achieved by drug card for lasix broadening the lens of what we consider essential to safety on maternity units to include prioritising patient experience, birthing with dignity and valuing low intervention rates. All of these domains need to be in balance. Good mother or baby medical outcomes at the cost of high rates of drug card for lasix intervention and high maternal psychological trauma are not a success, nor is the opposite.

The true ‘safe’ maternity unit is one that does well on all of these dimensions, which, of course, means that we need to be able to measure drug card for lasix each of them. Finally, all of these safety domains, including the ‘For Us’ framework proposed by Liberati and colleagues, focus on unit culture, provider behaviours and processes of care, and thus are within the reach of all maternity units no matter their level of resources.Healthcare-associated s (HCAIs) are those s acquired by an individual who is seeking medical care in any healthcare facility, including acute care hospitals, long-term care facilities (including nursing homes), outpatient surgical centres, dialysis centres or ambulatory care clinics.1 They are further defined as occurring at least 48 hours after hospitalisation or within 30 days of receiving medical care.2 HCAIs have plagued hospitals, physicians and patients for centuries and likely played a role in the reputation that hospitals historically had as dangerous places.3 In the mid-19th century, Ignaz Semmelweis observed that labouring mothers in an obstetrics unit had a high incidence of Puerperal (Childbed) fever, which he thought was related to direct contact with medical students. After working with cadavers, students often drug card for lasix moved directly from the anatomy lab to the hospital, leading Semmelweis to postulate that students were contaminated and bringing a pathogen into the unit.

He saw dramatic improvements in maternal mortality after introducing a chlorinated lime hand wash for healthcare providers.4 Though not quickly accepted at large, his observations would become part of the foundation of the germ theory that we intuitively accept today.Over a century after Semmelweis introduced the idea of hand hygiene, prevention in healthcare settings has been thrust into the spotlight worldwide. In the 1960s, the US Centers for Disease Control drug card for lasix and Prevention (CDC) conducted research within the Comprehensive Hospital s Project and introduced surveillance and control techniques still used today. The creation of the National Healthcare Safety Network (NHSN) propelled control onto a national public health platform in the USA.3 Today, reduction of HCAIs has become a regulatory, financial and quality imperative across the world.Healthcare frequently involves the use of invasive devices and procedures that can increase the risk of HCAIs, including catheter-associated urinary tract s, central-line associated bloodstream s (CLABSIs), surgical site s and ventilator-associated events.5 The development of antimicrobial resistance related to antibiotic misuse or overuse6 has given rise to multidrug-resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA), extended spectrum beta lactamase-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae and diarrheal s with Clostridioides difficile.

Today, most states in the USA have passed legislation mandating that healthcare facilities publicly report HCAIs, most often using the CDC NHSN surveillance drug card for lasix definition for event reporting.7 Globally, the WHO’s Clean Care is Safer Care Programme is working alongside many nations to introduce surveillance and reporting programmes to strengthen the international response.8The patient environment has become a major focus of control interventions. Although a large proportion of HCAIs are attributed to a patient’s endogenous microflora, up to 40% of nosocomial s are cross-s from the hands of healthcare providers, including transmission from high-touch patient-care surfaces.9 In order for pathogens to be transmitted, they generally must have characteristics that make them more robust in the environment, such as the ability to frequently colonise, survive and remain virulent on environmental surfaces and the ability to transiently colonise and pass from the hands of healthcare providers to patients or environmental surfaces.9 C. Difficile poses drug card for lasix additional challenges for environmental control because of its ability to form spores that resist dry heat and many disinfectants.9 Even with active surveillance and the introduction of new environmental dis technologies, such as uaviolet germicidal irradiation,10 studies have demonstrated that patients hospitalised in rooms with previous occupants who were MRSA colonised or infected with C.

Difficile were more likely to become contaminated,7 supporting the notion that hospital environments play an important role in HCAI transmission.Both the duration of hospitalisation and frequency of transfer between and within healthcare facilities increase the likelihood of exposure to contaminated environments. Intrahospital transfers refer to the movement of a patient within a healthcare facility, including transfers from the emergency room to an inpatient unit on admission, drug card for lasix between two different units, to a different department for a procedure or diagnostic study or between rooms on the same unit.11 McHaney-Lindstrom and colleagues conducted a retrospective case-control study that found that with every additional intrahospital transfer, the odds of acquiring an with C. Difficile increased by 7%.12 These transfers require a complex cascade of events and are affected by environmental control and communication challenges, professional conflicts related to variation in culture between units, hospital census and provider workload.13 In a systematic review, Bristol and colleagues found that intrahospital transfers are frequently associated with adverse outcomes, such drug card for lasix as delirium, increased risk of falls, increased length of stay and prolonged duration of mechanical ventilation and central venous catheterisation.13 This therefore further highlights the significance of intrahospital transfers on patient outcomes.In this issue, Boncea and colleagues report on a retrospective case-control study conducted to estimate the risk of developing a HCAI depending on the number of intrahospital transfers between inpatient units or the same unit.11 The study was conducted in three urban hospitals within one UK hospital organisation.

The study focused on patients aged 65 or older, given their higher frequency of access to medical care. Data were collected from the electronic health record (EHR) over a 3-year period and included a total of 24 240 hospitalisations of which 2877 were cases where drug card for lasix the patient had a positive clinical culture obtained at least 48 hours after hospitalisation. Cases and controls were matched by potential confounding variables, including Elixhauser comorbidities, age, gender and total number of admissions.

Using multivariable logistic regression modelling, they found that for every additional intrahospital transfer, the odds of acquiring a HCAI increased by 9%, with the most common HCAI drug card for lasix being C. Difficile .This study is one of the first to quantify the risk associated with the number of intrahospital transfers and HCAIs. Cases and controls were well matched, and the statistical drug card for lasix modelling provides very compelling results.

However, it is worth noting some features of the study that can affect the findings. The study drug card for lasix does not provide specific details on the active surveillance testing practices of the hospital network. Without these data, theoretically (and by chance), cases selected for this study could have been colonised by MRSA more frequently than controls, which would introduce a level of bias.

C. Difficile was measured from the EHR by positive toxin immunoassay results, but the clinical context of this testing is not clear, raising the possibility that some positive patients may have represented colonisation and not acute . The study also did not adjust for the indication for transfer (eg, transfer to or from the intensive care unit based on patient acuity, transfer for isolation precautions or transfer due to bed capacity or staffing issues) to determine if the patient care needs, isolation status or hospital strain modify the observed risk.

As the authors acknowledge, prospective studies are needed to identify the clinical, administrative and systems factors that contribute to more frequent intrahospital transfers.Guidelines for prevention and control of HCAIs include evidence-based interventions that can be broadly categorised as either vertical or horizontal. Vertical interventions focus on reducing colonisation, and transmission of specific pathogens,7 and include surveillance testing for asymptomatic carriers, contact isolation precautions and targeted decolonisation.7 Horizontal interventions aim to reduce the risk of by a larger group of pathogens, independent of patient-specific conditions, such as optimisation of hand hygiene, antimicrobial stewardship and environmental cleaning practices.7 control programmes are tasked with weighing the risks and benefits of interventions to reduce rates of HCAIs while also being cost effective. Vertical approaches to prevent MRSA transmission and remain controversial due to inconsistent findings.7 In a nationwide US Veteran’s Affairs study that assessed the impact of MRSA surveillance testing and contact isolation in MRSA carriers, researchers demonstrated that these interventions resulted in reduced rates of MRSA and colonisation as well as reductions in the incidence of healthcare-associated C.

Difficile and vancomycin-resistant Enterococcus s.14 In contrast, other studies evaluating similar practices in intensive care units found little impact of vertical control measures on MRSA rates15 and describe unintended consequences, such as decreased provider-patient contact, increased patient anxiety and patient dissatisfaction with quality of care.16Under endemic conditions, horizontal interventions may be more cost effective and beneficial given the broader number of microorganisms that can be targeted.7 Hand hygiene remains a core horizontal intervention, but hand hygiene compliance varies widely, with some countries’ hospitals compliance reported as low as 15%.17 Several studies focused on intensive care units have shown significant declines in MRSA colonisation rates when hand hygiene practices improve.7 In addition to hand hygiene, universal decolonisation strategies that typically use chlorhexidine gluconate bathing of high risk patients are more impactful than active surveillance testing for individual pathogens at reducing rates of HCAIs such as CLABSIs.7 A central pillar of control is antimicrobial stewardship. These programmes use coordinated interventions to promote appropriate antimicrobial use, improve patient outcomes, decrease antibiotic resistance and reduce the incidence of s secondary to multidrug-resistant organisms.18 Given variation in environmental dis practices and provider-to-provider communication, reducing the frequency of intrahospital transfers is another potential horizontal intervention to reduce the burden of HCAIs.Boncea and colleagues’ study adds to the growing body of literature that intrahospital transfers may increase the risk of HCAIs. Prior studies have identified that patients experience an average of 2.4 transfers during a hospitalisation and approximately 96% of individuals experience a transfer during hospitalisation.13 Transfers within the hospital also affect patient care and safety in other ways, resulting in delays in diagnosis and treatment due, in part, to poor coordination of care and inadequate handoffs between units.19 Additionally, intrahospital transfers take an average of 1 hour to complete, adding significantly to nursing workload.19The field of control must continue to adapt to changing hospital environments in order to further reduce the risk of HCAIs.

In the most recent progress report from US CDC, one in every 31 US patients will experience a HCAI while hospitalised,20 contributing to preventable deaths and permanent harm and to a tremendous excess cost of care.21 While the impact of these s is readily recognised in the developed world, recent studies indicate that the impact of HCAIs in the developing world is staggering, with one study reporting that the pooled-prevalence of HCAIs in resource-limited settings is 15.5 per 100 patients, compared with 4.5 per 100 patients in the USA and 7.1 per 100 patients in Europe.22 control programmes must continue to survey their respective hospital populations and evolve to the demand of the time, weighing benefits, balancing measures and costs. Reducing the number of intrahospital transfers and improving care coordination across these transitions represent a future opportunity to further reduce the burden of HCAIs..

What are the key features http://basementgold.com/ of hospitals that consistently deliver safe where to buy lasix online care on labour and delivery?. This is the primary question posed by Liberati where to buy lasix online and colleagues in this issue of BMJ Quality &. Safety.1 The authors propose a framework distilled from observations on a group of high-performing units in the UK participating in a training activity to improve patient safety.

This study combined ethnography with individual interviews and focus groups and involved over 400 hours where to buy lasix online of total observations at six different maternity care sites. The seven features in their resulting For Us framework correspond well to existing theoretical as well as applied quality improvement strategies. While we agree that their framework describes features that every labour and delivery unit should strive where to buy lasix online to include, this approach has some limitations in terms of generalisability.

Specifically, Liberati and colleagues studied maternity units that are high performing, but their sample included only large-volume hospitals in what appear to be well-resourced settings. What is potentially missing is observations on underperforming units, and how these findings may or may not apply to smaller, where to buy lasix online lower resourced settings. Additionally, the structure of the UK’s National Health Service (NHS) also limits generalisability.

For example, this is most analogous to employed physician models in the USA, with the potential advantage of where to buy lasix online a more organisationally oriented provider workforce. Given that most US hospitals do not have an employed provider model, we can’t assume that these factors will have the same impact in other models of care.In the USA, the Agency for Healthcare Research and Quality (AHRQ) developed a Culture of Safety framework that delineates four key features. (1) organisations recognise that their primary activities are inherently high risk where to buy lasix online and make it their goal to operate in a reliably safe manner.

(2) organisations where to buy lasix online create a safe and blame-free reporting environment. (3) interdisciplinary and interprofessional collaboration is encouraged to address safety problems. And (4) resources are deliberately allocated and made available to address safety.2 This framework, as does where to buy lasix online For Us, focuses on a healthcare-oriented conceptualisation of safety and quality, and details medical outcomes as the primary metrics by which to measure success.

Although achievement of these medical quality outcomes is imperative, we propose that there are additional domains needed to provide safe intrapartum care. (A) prioritising patient experience—including emotional safety, birthing with dignity and an where to buy lasix online expectation of person-centred care. And (B) a unit culture that values low intervention births.

Let us where to buy lasix online consider these domains in more depth.Patient experience and safety are inextricable. While much work has been done to improve physician–patient communication,3 4 few have successfully targeted the perpetuation of dysfunctional behaviours grounded in healthcare professionals’ implicit and explicit biases.5 This may be in part due to the tendency to observe and look for answers from the standpoint of the healthcare system rather than patients. Women who had recently given birth were included in the study of Liberati and colleagues, but represented only 8 of 65 individual stakeholder interviews, and were not included in focus groups where to buy lasix online.

The framework thus describes a where to buy lasix online high-functioning system from primarily the healthcare system’s perspective. In general, the patient’s role in achieving safe care includes many aspects, including providing personal information to reach the correct diagnosis, providing their values and lived experience in shared decision-making discussions, choosing their provider such that their needs regarding provider experience and safe practice are met, making sure that they receive the recommended treatments in a timely manner, as well as identifying and reporting errors.6 The detriment to health outcomes among patients who have failed interactions with providers is well documented (eg, leaving against medical advice or experiencing disrespect during their care) while other harms, such as psychological trauma, often go unmeasured.7Emotional and psychological trauma are safety errors, whether or not a patient leaves the hospital physically intact.8 Research has shown that patients experience psychological trauma both as a result of an adverse outcome and as a result of how the incident was managed. In birth, patients conceptualise the meaning of safety very differently from that of the medical system, with physical and emotional safety being inextricably interwoven into a single concept.9 Psychological trauma may manifest in postpartum depression, post-traumatic stress disorder10 and, some studies suggest, reduced childbearing in patients who experience traumatic birth.11 The experience of emotional safety on the part of the patient is only knowable to the patient, and only addressable when health systems—and health services research—ask the appropriate where to buy lasix online questions.

Therefore, patient-reported experience measures and critical examination of the process of patient-centred care should be at the centre of quality improvement.High-performing units prioritise patient voice and patient experience as a part of their culture. In a recent article, Morton and Simkin12 delineate steps to promote respectful maternity care in institutions, including obtaining unit commitment to respectful care, implementing training programmes to support respectful care as the norm and, finally, instituting respectful treatment of healthcare staff and clinicians by administrators and where to buy lasix online leaders—in other words, a unit culture of mutual respect and care among the entire team enables respectful care of the patient. Liberati and colleagues address the issue of hierarchies on labour and delivery, making the key observation that high-performing units create hierarchies around expertise rather than formal titles or disciplinary silos.

However, this power differential applies to patients where to buy lasix online as well. The existing hierarchy on most labour units places physicians at the top and patients at the bottom, which often acts to silence patients’ voices.13 Implicit bias and interpersonal racism and sexism contribute to this cycle of silence and mistreatment on labour and delivery units.14 Disrespect and dismissal of patient concerns have been increasingly described, but still lack quantitative measurement in association with maternal and child health outcomes.15 Interventions aimed at harm reduction are emerging,16 but more work is desperately needed in this area.Valuing low intervention is an important dimension of safety. Safety culture, as it is conceptualised by AHRQ and the current study, is ideally where to buy lasix online created to prevent or respond to harmful safety lapses.

This model is more difficult to apply to an environment where the goal is safe facilitation of a normal biological process. In this setting, interventions (that where to buy lasix online often beget more interventions) can increase complications. High rates of primary and repeat caesarean deliveries, and other invasive obstetric interventions seen in many birthing where to buy lasix online units are now widely acknowledged to be overused and overuse constitutes a patient safety risk.17 In our work in California, we have been able to demonstrate that provider attitudes, beliefs and unit culture can drive caesarean delivery overuse in ways that do not contribute to patient safety.18 19 Each intervention needs to be carefully and jointly considered for value and safety.

This in no way diminishes the life-saving nature of caesarean delivery when it is medically indicated, but it sets up the expectation that safety measures, processes and procedures must be in place to actively work towards supporting vaginal birth rather than treating each labour as an emergency waiting to happen. The striking variation in obstetric intervention rates among hospitals and providers can where to buy lasix online provide critical insights. So, what is the right balance of intervention rates and mother/baby safety outcomes?.

In many instances, where to buy lasix online this may be a false dichotomy. In a study of California hospital labour practices, Lundsberg et al found that hospitals that prioritised low labour interventions and actively supported vaginal birth (eg, delaying admission until active labour onset, use of doulas, intermittent auscultation of fetal heart tones, non-pharmacological pain relief, and so on) had reduced caesarean delivery rates with well-preserved neonatal outcomes.20 It should be noted that in the USA, rates of intervention are starting at a high level so there is less danger of harm from achieving too low a rate. This may not visite site be the case in the UK where there are now formal inquiries examining obstetric care in multiple NHS hospital trusts where poor perinatal outcomes have been linked to a systematic aversion to medical interventions even when indicated.21 Getting this where to buy lasix online balance right has been referred to as the Goldilocks quandary.

Doing too little, too much or just right?. 22In conclusion, physical safety is where to buy lasix online the bare minimum of what should be expected in childbirth. Patients have a right, and healthcare providers and systems have an obligation to aim higher, to ensure patients emerge from childbirth as healthy or healthier—both physically and psychologically—than before entering the hospital.

This can be best achieved by broadening the lens of what we consider essential to safety on maternity units to include prioritising patient where to buy lasix online experience, birthing with dignity and valuing low intervention rates. All of these domains need to be in balance. Good mother or baby medical outcomes at the cost of high rates of intervention where to buy lasix online and high maternal psychological trauma are not a success, nor is the opposite.

The true ‘safe’ maternity unit where to buy lasix online is one that does well on all of these dimensions, which, of course, means that we need to be able to measure each of them. Finally, all of these safety domains, including the ‘For Us’ framework proposed by Liberati and colleagues, focus on unit culture, provider behaviours and processes of care, and thus are within the reach of all maternity units no matter their level of resources.Healthcare-associated s (HCAIs) are those s acquired by an individual who is seeking medical care in any healthcare facility, including acute care hospitals, long-term care facilities (including nursing homes), outpatient surgical centres, dialysis centres or ambulatory care clinics.1 They are further defined as occurring at least 48 hours after hospitalisation or within 30 days of receiving medical care.2 HCAIs have plagued hospitals, physicians and patients for centuries and likely played a role in the reputation that hospitals historically had as dangerous places.3 In the mid-19th century, Ignaz Semmelweis observed that labouring mothers in an obstetrics unit had a high incidence of Puerperal (Childbed) fever, which he thought was related to direct contact with medical students. After working with cadavers, students often moved directly from the anatomy lab to the where to buy lasix online hospital, leading Semmelweis to postulate that students were contaminated and bringing a pathogen into the unit.

He saw dramatic improvements in maternal mortality after introducing a chlorinated lime hand wash for healthcare providers.4 Though not quickly accepted at large, his observations would become part of the foundation of the germ theory that we intuitively accept today.Over a century after Semmelweis introduced the idea of hand hygiene, prevention in healthcare settings has been thrust into the spotlight worldwide. In the where to buy lasix online 1960s, the US Centers for Disease Control and Prevention (CDC) conducted research within the Comprehensive Hospital s Project and introduced surveillance and control techniques still used today. The creation of the National Healthcare Safety Network (NHSN) propelled control onto a national public health platform in the USA.3 Today, reduction of HCAIs has become a regulatory, financial and quality imperative across the world.Healthcare frequently involves the use of invasive devices and procedures that can increase the risk of HCAIs, including catheter-associated urinary tract s, central-line associated bloodstream s (CLABSIs), surgical site s and ventilator-associated events.5 The development of antimicrobial resistance related to antibiotic misuse or overuse6 has given rise to multidrug-resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA), extended spectrum beta lactamase-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae and diarrheal s with Clostridioides difficile.

Today, most states in the USA have passed legislation mandating that healthcare facilities publicly report HCAIs, most often using the CDC NHSN surveillance definition for event reporting.7 Globally, the WHO’s Clean Care where to buy lasix online is Safer Care Programme is working alongside many nations to introduce surveillance and reporting programmes to strengthen the international response.8The patient environment has become a major focus of control interventions. Although a large proportion of HCAIs are attributed to a patient’s endogenous microflora, up to 40% of nosocomial s are cross-s from the hands of healthcare providers, including transmission from high-touch patient-care surfaces.9 In order for pathogens to be transmitted, they generally must have characteristics that make them more robust in the environment, such as the ability to frequently colonise, survive and remain virulent on environmental surfaces and the ability to transiently colonise and pass from the hands of healthcare providers to patients or environmental surfaces.9 C. Difficile poses additional challenges for environmental control because of its ability to form spores that resist dry heat and many disinfectants.9 Even with active surveillance and the introduction of new environmental dis technologies, such as uaviolet germicidal irradiation,10 studies have demonstrated that patients hospitalised in rooms with previous occupants who were where to buy lasix online MRSA colonised or infected with C.

Difficile were more likely to become contaminated,7 supporting the notion that hospital environments play an important role in HCAI transmission.Both the duration of hospitalisation and frequency of transfer between and within healthcare facilities increase the likelihood of exposure to contaminated environments. Intrahospital transfers refer to the movement of a patient within a healthcare facility, including transfers from the emergency room to an inpatient unit on admission, between two different units, to a different department for a procedure or diagnostic study or between rooms on the same unit.11 McHaney-Lindstrom and colleagues conducted where to buy lasix online a retrospective case-control study that found that with every additional intrahospital transfer, the odds of acquiring an with C. Difficile increased by 7%.12 These transfers require a complex cascade of events and are affected by environmental control and communication challenges, professional conflicts related to variation in culture between units, hospital census and provider workload.13 In a systematic review, Bristol and colleagues found that intrahospital transfers are frequently associated with adverse outcomes, such as delirium, increased risk of falls, increased length of stay and prolonged duration of mechanical ventilation and central venous catheterisation.13 This therefore further highlights the significance of intrahospital transfers on patient outcomes.In this issue, Boncea and colleagues report on a retrospective case-control study conducted to estimate the risk of developing a HCAI depending on the number of where to buy lasix online intrahospital transfers between inpatient units or the same unit.11 The study was conducted in three urban hospitals within one UK hospital organisation.

The study focused on patients aged 65 or older, given their higher frequency of access to medical care. Data were collected from the electronic health record (EHR) over a 3-year period and included a total of 24 240 hospitalisations of which 2877 were cases where the patient had a positive clinical culture obtained at least 48 hours where to buy lasix online after hospitalisation. Cases and controls were matched by potential confounding variables, including Elixhauser comorbidities, age, gender and total number of admissions.

Using multivariable logistic regression modelling, they found that for every additional where to buy lasix online intrahospital transfer, the odds of acquiring a HCAI increased by 9%, with the most common HCAI being C. Difficile .This study is one of the first to quantify the risk associated with the number of intrahospital transfers and HCAIs. Cases and where to buy lasix online controls were well matched, and the statistical modelling provides very compelling results.

However, it is worth noting some features of the study that can affect the findings. The study does not provide specific where to buy lasix online details on the active surveillance testing practices of the hospital network. Without these data, theoretically (and by chance), cases selected for this study could have been colonised by MRSA more frequently than controls, which would introduce a level of bias.

C. Difficile was measured from the EHR by positive toxin immunoassay results, but the clinical context of this testing is not clear, raising the possibility that some positive patients may have represented colonisation and not acute . The study also did not adjust for the indication for transfer (eg, transfer to or from the intensive care unit based on patient acuity, transfer for isolation precautions or transfer due to bed capacity or staffing issues) to determine if the patient care needs, isolation status or hospital strain modify the observed risk.

As the authors acknowledge, prospective studies are needed to identify the clinical, administrative and systems factors that contribute to more frequent intrahospital transfers.Guidelines for prevention and control of HCAIs include evidence-based interventions that can be broadly categorised as either vertical or horizontal. Vertical interventions focus on reducing colonisation, and transmission of specific pathogens,7 and include surveillance testing for asymptomatic carriers, contact isolation precautions and targeted decolonisation.7 Horizontal interventions aim to reduce the risk of by a larger group of pathogens, independent of patient-specific conditions, such as optimisation of hand hygiene, antimicrobial stewardship and environmental cleaning practices.7 control programmes are tasked with weighing the risks and benefits of interventions to reduce rates of HCAIs while also being cost effective. Vertical approaches to prevent MRSA transmission and remain controversial due to inconsistent findings.7 In a nationwide US Veteran’s Affairs study that assessed the impact of MRSA surveillance testing and contact isolation in MRSA carriers, researchers demonstrated that these interventions resulted in reduced rates of MRSA and colonisation as well as reductions in the incidence of healthcare-associated C.

Difficile and vancomycin-resistant Enterococcus s.14 In contrast, other studies evaluating similar practices in intensive care units found little impact of vertical control measures on MRSA rates15 and describe unintended consequences, such as decreased provider-patient contact, increased patient anxiety and patient dissatisfaction with quality of care.16Under endemic conditions, horizontal interventions may be more cost effective and beneficial given the broader number of microorganisms that can be targeted.7 Hand hygiene remains a core horizontal intervention, but hand hygiene compliance varies widely, with some countries’ hospitals compliance reported as low as 15%.17 Several studies focused on intensive care units have shown significant declines in MRSA colonisation rates when hand hygiene practices improve.7 In addition to hand hygiene, universal decolonisation strategies that typically use chlorhexidine gluconate bathing of high risk patients are more impactful than active surveillance testing for individual pathogens at reducing rates of HCAIs such as CLABSIs.7 A central pillar of control is antimicrobial stewardship. These programmes use coordinated interventions to promote appropriate antimicrobial use, improve patient outcomes, decrease antibiotic resistance and reduce the incidence of s secondary to multidrug-resistant organisms.18 Given variation in environmental dis practices and provider-to-provider communication, reducing the frequency of intrahospital transfers is another potential horizontal intervention to reduce the burden of HCAIs.Boncea and colleagues’ study adds to the growing body of literature that intrahospital transfers may increase the risk of HCAIs. Prior studies have identified that patients experience an average of 2.4 transfers during a hospitalisation and approximately 96% of individuals experience a transfer during hospitalisation.13 Transfers within the hospital also affect patient care and safety in other ways, resulting in delays in diagnosis and treatment due, in part, to poor coordination of care and inadequate handoffs between units.19 Additionally, intrahospital transfers take an average of 1 hour to complete, adding significantly to nursing workload.19The field of control must continue to adapt to changing hospital environments in order to further reduce the risk of HCAIs.

In the most recent progress report from US CDC, one in every 31 US patients will experience a HCAI while hospitalised,20 contributing to preventable deaths and permanent harm and to a tremendous excess cost of care.21 While the impact of these s is readily recognised in the developed world, recent studies indicate that the impact of HCAIs in the developing world is staggering, with one study reporting that the pooled-prevalence of HCAIs in resource-limited settings is 15.5 per 100 patients, compared with 4.5 per 100 patients in the USA and 7.1 per 100 patients in Europe.22 control programmes must continue to survey their respective hospital populations and evolve to the demand of the time, weighing benefits, balancing measures and costs. Reducing the number of intrahospital transfers and improving care coordination across these transitions represent a future opportunity to further reduce the burden of HCAIs..

What should I tell my health care provider before I take Lasix?

They need to know if you have any of these conditions:

  • abnormal blood electrolytes
  • diarrhea or vomiting
  • gout
  • heart disease
  • kidney disease, small amounts of urine, or difficulty passing urine
  • liver disease
  • an unusual or allergic reaction to furosemide, sulfa drugs, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

Lasix dosage for chf exacerbation

Start Preamble Notice lasix dosage for chf exacerbation of Amendment and http://margaretarts.com/new-works-small-paintings/ Republished Declaration. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against hypertension medications. The amendments to the Declaration are applicable as of February 4, 2020, lasix dosage for chf exacerbation except as otherwise specified in Section XII. Start Further Info Robert P.

Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue Start Printed Page 79191SW, Washington, DC 20201. Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C.

247d-6d et. Seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act. Such declarations are subject to amendment as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2.

It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the lasix and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the hypertension Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response to the hypertension Disease 2019 (hypertension medications) outbreak, which subsequently became a global lasix. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020.

On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against hypertension medications.[] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.[] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified lasix and epidemic products that limit the harm that hypertension medications might otherwise cause.[] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.[] The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act. This Fourth Amendment to the Declaration. (a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).[] The Declaration incorporates the Advisory Opinions for that purpose. (b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.[] (c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C.

247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.[] (d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or hypertension medications vaccinations. (e) Makes explicit that Section VI covers all qualified lasix and epidemic products under the PREP Act. (f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C. 247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels.

(g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. (h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the hypertension medications lasix among federal, state, local, and private-sector entities. The world is facing an unprecedented lasix. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.Start Printed Page 79192 (i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.[] The Secretary republishes the Declaration, as amended, in full.

Unless otherwise noted, all statutory citations are to the U.S. Code. Description of This Amendment Declaration The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against hypertension medications. OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary's interpretation of the Declaration.[] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions.

The Secretary expressly incorporates the Advisory Opinions for that purpose. Section V. Covered Persons Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act. The Secretary amends Section V to specify an additional category of qualified persons.

Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth. Telehealth is widely recognized as a valuable tool to promote public health during this lasix. According to the Centers for Disease Control and Prevention (CDC), Telehealth services can facilitate public health mitigation strategies during this lasix by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures.

They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers. Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible.

Telehealth services can be used to. Screen patients who may have symptoms of hypertension medications and refer as appropriate Provide low-risk urgent care for non-hypertension medications conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments) Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility) Follow up with patients after hospitalization Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs Provide non-emergent care to residents in long-term care facilities Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.[] Similarly, CMS has stressed the importance of telehealth during this lasix. Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health. Innovative uses of this kind of technology in the provision of healthcare is increasing.

And with the emergence of the lasix causing the disease hypertension medications, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the lasix, as well as limiting the exposure to other patients and staff members will slow viral spread.[] Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this lasix. Other HHS components have also taken steps to expand the use of telehealth during the lasix.[] Moreover, to expand the use of telehealth during this lasix, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the hypertension medications nationwide public health emergency.[] This exercise of discretion Start Printed Page 79193applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to hypertension medications.[] Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of hypertension medications.[] To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.

When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain hypertension medications tests and certain treatments.[] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education. The Secretary also amends Section V's training requirements for licensed pharmacists to order and administer certain childhood or hypertension medications treatments. To order and administer treatments, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) who can order or administer childhood or hypertension medications treatments pursuant to the Declaration. Section VI.

Covered Countermeasures The Secretary amends Section VI to make explicit that Section VI covers all qualified lasix and epidemic products under the PREP Act.Start Printed Page 79194 Section VII. Limitations on Distribution The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution. The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements. Or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency.

hypertension medications is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this lasix, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below. The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is. (a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from hypertension medications, or the transmission of hypertension or a lasix mutating therefrom.

Or (b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a hypertension medications test pursuant to an FDA Emergency Use Authorization for that hypertension medications test.

If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction. Section IX. Administration of Covered Countermeasures The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. Section XI.

Geographic Area The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V. Darue Eng'g.

&. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the hypertension medications lasix among federal, state, local, and private-sector entities. The world is facing an unprecedented global lasix.

To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations. Section XII.

Effective Time Period The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. This change is to conform the text of the Declaration to the Third Amendment.[] The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published. Additional Amendments The Secretary also makes other, non-substantive amendments.

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against hypertension medications To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions Start Printed Page 79195of the Office of the General Counsel (Advisory Opinions). I incorporate those Advisory Opinions as part of this Declaration.[] This Declaration is a “requirement” under the PREP Act. I.

Determination of Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of hypertension or a lasix mutating therefrom and the resulting disease hypertension medications constitutes a public health emergency. I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation's healthcare community to the hypertension medications outbreak. II.

Factors Considered 42 U.S.C. 247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C.

247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Protections 42 U.S.C. 247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act. Their officials, agents, and employees.

And the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; [] (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), [] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) FDA-authorized or FDA-licensed hypertension medications treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. In the case of a hypertension medications treatment, the vaccination must be ordered and administered according to ACIP's hypertension medications treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Start Printed Page 79196Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

V. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vi.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. Viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.

And ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. X. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) hypertension medications vaccination provider agreement and any other federal requirements that apply to the administration of hypertension medications treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered Countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures.

VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7) Covered Countermeasures are.

(a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any treatment manufactured, used, designed, developed, modified, licensed, or procured. I. To diagnose, mitigate, prevent, treat, or cure hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. Or ii.

To limit the harm that hypertension medications, or the transmission of hypertension or a lasix mutating therefrom, might otherwise cause. (b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above. (c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above. Or (d) any device used in the administration of any such product, and all components and constituent materials of any such product.

To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of “Covered Countermeasure.” VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving.

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements. (b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency. Or (c) Covered Countermeasures that are. I.

Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. OrStart Printed Page 79197 ii. A respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings. (a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. (b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation.

(b) commercial sale. (c) deployment of Covered Countermeasures from federal stockpiles. Or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only hypertension medications caused by hypertension, or a lasix mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by hypertension medications, hypertension, or a lasix mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. IX. Administration of Covered Countermeasures 42 U.S.C.

247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures. Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to. . .

The administration to. . . An individual” under 42 U.S.C.

247d-6d. For example, consider a situation where there is only one dose [] of a hypertension medications treatment, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional. In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to hypertension medications. In that circumstance, the failure to administer the hypertension medications treatment to the person in a less-vulnerable population “relat[es] to.

. . The administration to” the person in a vulnerable population. The person in the vulnerable population was able to receive the treatment only because it was not administered to the person in the less-vulnerable population.

Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority's directive, can fall within the PREP Act and this Declaration's liability protections. X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area 42 U.S.C.

247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. hypertension medications is a global challenge that requires a whole-of-nation response.

There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V. Darue Eng'g.

&. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the hypertension medications lasix among federal, state, local, and private-sector entities. The world is facing an unprecedented lasix.

To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party's exclusive remedy is an administrative Start Printed Page 79198remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.[] XII. Effective Time Period 42 U.S.C.

247d-6d(b)(2)(B) Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.

Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as warranted.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated. December 3, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-26977 Filed 12-8-20.

Start Preamble view it now Notice where to buy lasix online of Amendment and Republished Declaration. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to amend his March 10, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against hypertension medications. The amendments to the Declaration are where to buy lasix online applicable as of February 4, 2020, except as otherwise specified in Section XII. Start Further Info Robert P.

Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue Start Printed Page 79191SW, Washington, DC 20201. Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C.

247d-6d et. Seq., authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct,” as defined in the PREP Act. Such declarations are subject to amendment as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2.

It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

Section 319F-3 of the PHS Act has been amended by the lasix and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013, and the hypertension Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act. On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response to the hypertension Disease 2019 (hypertension medications) outbreak, which subsequently became a global lasix. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 21, 2020, July 23, 2020, and October 2, 2020.

On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against hypertension medications.[] On April 10, the Secretary amended the Declaration to extend liability protections to Covered Countermeasures authorized under the CARES Act.[] On June 4, the Secretary amended the Declaration to clarify that Covered Countermeasures under the Declaration include qualified lasix and epidemic products that limit the harm that hypertension medications might otherwise cause.[] On August 19, the Secretary amended the Declaration to add additional categories of Qualified Persons and to amend the category of disease, health condition, or threat for which he recommends the administration or use of Covered Countermeasures.[] The Secretary now further amends the Declaration pursuant to section 319F-3 of the Public Health Service Act. This Fourth Amendment to the Declaration. (a) Clarifies that the Declaration must be construed in accordance with the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) Advisory Opinions on the Public Readiness and Emergency Preparedness Act and the Declaration (Advisory Opinions).[] The Declaration incorporates the Advisory Opinions for that purpose. (b) Incorporates authorizations that the HHS Office of the Assistant Secretary for Health (OASH) has issued as an Authority Having Jurisdiction.[] (c) Adds an additional category of Qualified Persons under Section V of the Declaration and 42 U.S.C.

247d-6d(i)(8)(B), i.e., healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.[] (d) Modifies and clarifies the training requirements for certain licensed pharmacists and pharmacy interns to administer certain routine childhood or hypertension medications vaccinations. (e) Makes explicit that Section VI covers all qualified lasix and epidemic products under the PREP Act. (f) Adds a third method of distribution under Section VII of the Declaration and 42 U.S.C. 247d-6d(a)(5) that would provide liability protections for, among other things, additional private-distribution channels.

(g) Makes explicit in Section IX that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. (h) Makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests, in having a unified, whole-of-nation response to the hypertension medications lasix among federal, state, local, and private-sector entities. The world is facing an unprecedented lasix. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.Start Printed Page 79192 (i) Revises the effective time period of the Declaration in light of the amendments to the Declaration.[] The Secretary republishes the Declaration, as amended, in full.

Unless otherwise noted, all statutory citations are to the U.S. Code. Description of This Amendment Declaration The Declaration has fifteen sections describing PREP Act coverage for medical countermeasures against hypertension medications. OGC has issued Advisory Opinions interpreting the PREP Act and reflecting the Secretary's interpretation of the Declaration.[] The Secretary now amends the Declaration to clarify that the Declaration must be construed in accordance with the Advisory Opinions.

The Secretary expressly incorporates the Advisory Opinions for that purpose. Section V. Covered Persons Section V of the Declaration describes Covered Persons, including additional qualified persons identified by the Secretary, as required under the PREP Act. The Secretary amends Section V to specify an additional category of qualified persons.

Specifically, healthcare personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state so long as the healthcare personnel comply with the legal requirements of the state in which the healthcare personnel are permitted to order and administer the Covered Countermeasure by means of telehealth. Telehealth is widely recognized as a valuable tool to promote public health during this lasix. According to the Centers for Disease Control and Prevention (CDC), Telehealth services can facilitate public health mitigation strategies during this lasix by increasing social distancing. These services can be a safer option for [healthcare personnel (HCP)] and patients by reducing potential infectious exposures.

They can reduce the strain on healthcare systems by minimizing the surge of patient demand on facilities and reduce the use of [personal protective equipment (PPE)] by healthcare providers. Maintaining continuity of care to the extent possible can avoid additional negative consequences from delayed preventive, chronic, or routine care. Remote access to healthcare services may increase participation for those who are medically or socially vulnerable or who do not have ready access to providers. Remote access can also help preserve the patient-provider relationship at times when an in-person visit is not practical or feasible.

Telehealth services can be used to. Screen patients who may have symptoms of hypertension medications and refer as appropriate Provide low-risk urgent care for non-hypertension medications conditions, identify those persons who may need additional medical consultation or assessment, and refer as appropriate Access primary care providers and specialists, including mental and behavioral health, for chronic health conditions and medication management Provide coaching and support for patients managing chronic health conditions, including weight management and nutrition counseling Participate in physical therapy, occupational therapy, and other modalities as a hybrid approach to in-person care for optimal health Monitor clinical signs of certain chronic medical conditions (e.g., blood pressure, blood glucose, other remote assessments) Engage in case management for patients who have difficulty accessing care (e.g., those who live in very rural settings, older adults, those with limited mobility) Follow up with patients after hospitalization Deliver advance care planning and counseling to patients and caregivers to document preferences if a life-threatening event or medical crisis occurs Provide non-emergent care to residents in long-term care facilities Provide education and training for HCP through peer-to-peer professional medical consultations (inpatient or outpatient) that are not locally available, particularly in rural areas.[] Similarly, CMS has stressed the importance of telehealth during this lasix. Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient's health. Innovative uses of this kind of technology in the provision of healthcare is increasing.

And with the emergence of the lasix causing the disease hypertension medications, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. Limiting community spread of the lasix, as well as limiting the exposure to other patients and staff members will slow viral spread.[] Accordingly, CMS and other HHS components has substantially expanded the scope of services paid under Medicare when furnished using telehealth technologies during this lasix. Other HHS components have also taken steps to expand the use of telehealth during the lasix.[] Moreover, to expand the use of telehealth during this lasix, the Office for Civil Rights (OCR) at HHS is exercising enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) Rules against covered healthcare providers that serve patients through everyday communications technologies during the hypertension medications nationwide public health emergency.[] This exercise of discretion Start Printed Page 79193applies to widely available communications apps, such as FaceTime or Skype, when used in good faith for any telehealth treatment or diagnostic purpose, regardless of whether the telehealth service is directly related to hypertension medications.[] Many states have authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of hypertension medications.[] To help maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) includes healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.

When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. The Secretary also amends Section V to include several examples of Covered Persons who are Qualified Persons, because they are authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures. Those examples include certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain hypertension medications tests and certain treatments.[] These examples are not an exclusive or exhaustive list of persons who are qualified persons identified by the Secretary in Section V.

The Secretary also amends Section V to make explicit that the requirement in that section for certain qualified persons to have a current certificate in basic cardiopulmonary resuscitation is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education (ACPE), or the Accreditation Council for Continuing Medical Education. The Secretary also amends Section V's training requirements for licensed pharmacists to order and administer certain childhood or hypertension medications treatments. To order and administer treatments, the licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE) to order and administer treatments.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Other than the basic cardiopulmonary resuscitation requirement and the practical training program requirement, this Amendment does not change the requirements for a pharmacist, pharmacy intern, or pharmacy technician to be a “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) who can order or administer childhood or hypertension medications treatments pursuant to the Declaration. Section VI.

Covered Countermeasures The Secretary amends Section VI to make explicit that Section VI covers all qualified lasix and epidemic products under the PREP Act.Start Printed Page 79194 Section VII. Limitations on Distribution The Secretary may specify that liability protections are in effect only for Covered Countermeasures obtained through a particular means of distribution. The Declaration previously stated that liability immunity is afforded to Covered Persons only for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements. Or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a declaration of an emergency.

hypertension medications is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local- distribution channels as well as private-distribution channels. Given the broad scale of this lasix, the Secretary amends the Declaration to extend PREP Act coverage to additional private-distribution channels, as set forth below. The amended Section VII adds that PREP Act liability protections also extend to Covered Persons for Recommended Activities that are related to any Covered Countermeasure that is. (a) Licensed, approved, cleared, or authorized by the Food and Drug Administration (FDA) (or that is permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the Federal Food, Drug, and Cosmetic (FD&C) Act or Public Health Service (PHS) Act to treat, diagnose, cure, prevent, mitigate or limit the harm from hypertension medications, or the transmission of hypertension or a lasix mutating therefrom.

Or (b) a respiratory protective device approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from, hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. To qualify for this third distribution channel (but not necessarily to qualify for the other distribution channels), a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval. This third distribution channel may extend PREP Act coverage when there is no federal agreement or authorization in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a declaration of an emergency. For example, a manufacturer, distributor, program planner, or qualified person engages in manufacturing, testing, development, distribution, administration, or use of a hypertension medications test pursuant to an FDA Emergency Use Authorization for that hypertension medications test.

If the Covered Person satisfies all other requirements of the PREP Act and Declaration, there will be PREP Act coverage even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction. Section IX. Administration of Covered Countermeasures The Secretary amends Section IX to make explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration's liability protections. Section XI.

Geographic Area The Secretary makes explicit in Section XI that there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V. Darue Eng'g.

&. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the hypertension medications lasix among federal, state, local, and private-sector entities. The world is facing an unprecedented global lasix.

To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons is an exclusive Federal cause of action against a Covered Person for death or serious physical injury proximately caused by willful misconduct by such Covered Person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations. Section XII.

Effective Time Period The Secretary amends Section XII to provide that liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begins with a “Declaration of Emergency,” as defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, PREP Act coverage began on August 24, 2020), and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. This change is to conform the text of the Declaration to the Third Amendment.[] The Secretary also amends Section XII to provide that liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begins on the date of this amended Declaration and lasts through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Because the Secretary is adding Section VII(c) to the Declaration in this Amendment, Section XII provides that Section VII(c) is effective as of the date this amended Declaration is published. Additional Amendments The Secretary also makes other, non-substantive amendments.

Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Medical Countermeasures Against hypertension medications To the extent any term previously in the Declaration, including its amendments, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling. This Declaration must be construed in accordance with the Advisory Opinions Start Printed Page 79195of the Office of the General Counsel (Advisory Opinions). I incorporate those Advisory Opinions as part of this Declaration.[] This Declaration is a “requirement” under the PREP Act. I.

Determination of Public Health Emergency 42 U.S.C. 247d-6d(b)(1) I have determined that the spread of hypertension or a lasix mutating therefrom and the resulting disease hypertension medications constitutes a public health emergency. I further determine that use of any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, is a priority for use during the public health emergency that I declared on January 31, 2020 under section 319 of the PHS Act for the entire United States to aid in the response of the nation's healthcare community to the hypertension medications outbreak. II.

Factors Considered 42 U.S.C. 247d-6d(b)(6) I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures. III. Recommended Activities 42 U.S.C.

247d-6d(b)(1) I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures. IV. Liability Protections 42 U.S.C. 247d-6d(a), 247d-6d(b)(1) Liability protections as prescribed in the PREP Act and conditions stated in this Declaration are in effect for the Recommended Activities described in Section III.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability protections under this Declaration are “manufacturers,” “distributors,” “program planners,” and “qualified persons,” as those terms are defined in the PREP Act. Their officials, agents, and employees.

And the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of Emergency, as that term is defined in Section VII of this Declaration; [] (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

(d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), [] (1) treatments that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or (2) FDA-authorized or FDA-licensed hypertension medications treatments to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. I. The treatment must be authorized, approved, or licensed by the FDA.

Ii. In the case of a hypertension medications treatment, the vaccination must be ordered and administered according to ACIP's hypertension medications treatment recommendation(s). Iii. In the case of a childhood treatment, the vaccination must be ordered and administered according to ACIP's standard immunization schedule.

Iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order for pharmacists to order and administer treatments. If the State does not specify training requirements for the licensed pharmacist to order and administer treatments, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Start Printed Page 79196Council for Pharmacy Education (ACPE) to order and administer treatments. Such a training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments.

V. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of treatments, and the recognition and treatment of emergency reactions to treatments. Vi.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; [] vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. Viii. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers treatments, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (treatment registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a treatment must review the treatment registry or other vaccination records prior to administering a treatment.

And ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. X. The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) hypertension medications vaccination provider agreement and any other federal requirements that apply to the administration of hypertension medications treatment(s).

(e) Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.[] Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services. Nothing in this Declaration shall be construed to affect the National treatment Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered Countermeasures that are subject to the National treatment Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such Covered Countermeasures.

VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7) Covered Countermeasures are.

(a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any treatment manufactured, used, designed, developed, modified, licensed, or procured. I. To diagnose, mitigate, prevent, treat, or cure hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. Or ii.

To limit the harm that hypertension medications, or the transmission of hypertension or a lasix mutating therefrom, might otherwise cause. (b) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above. (c) a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above. Or (d) any device used in the administration of any such product, and all components and constituent materials of any such product.

To be a Covered Countermeasure under the Declaration, a product must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of “Covered Countermeasure.” VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E) I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving.

(a) Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements. (b) Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency. Or (c) Covered Countermeasures that are. I.

Licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. OrStart Printed Page 79197 ii. A respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from hypertension medications, or the transmission of hypertension or a lasix mutating therefrom. To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

As used in this Declaration, the terms “Authority Having Jurisdiction” and “Declaration of Emergency” have the following meanings. (a) The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. (b) A Declaration of Emergency means any declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such declaration specifies otherwise. I have also determined that, for governmental program planners only, liability protections are afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (a) donation.

(b) commercial sale. (c) deployment of Covered Countermeasures from federal stockpiles. Or (d) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only hypertension medications caused by hypertension, or a lasix mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by hypertension medications, hypertension, or a lasix mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. IX. Administration of Covered Countermeasures 42 U.S.C.

247d-6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures. Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to. . .

The administration to. . . An individual” under 42 U.S.C.

247d-6d. For example, consider a situation where there is only one dose [] of a hypertension medications treatment, and a person in a vulnerable population and a person in a less vulnerable population both request it from a healthcare professional. In that situation, the healthcare professional administers the one dose to the person who is more vulnerable to hypertension medications. In that circumstance, the failure to administer the hypertension medications treatment to the person in a less-vulnerable population “relat[es] to.

. . The administration to” the person in a vulnerable population. The person in the vulnerable population was able to receive the treatment only because it was not administered to the person in the less-vulnerable population.

Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority's directive, can fall within the PREP Act and this Declaration's liability protections. X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C) The populations of individuals to whom the liability protections of this Declaration extend include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area 42 U.S.C.

247d-6d(a)(4), 247d-6d(b)(2)(D) Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area. Liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. hypertension medications is a global challenge that requires a whole-of-nation response.

There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V. Darue Eng'g.

&. Mf'g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the hypertension medications lasix among federal, state, local, and private-sector entities. The world is facing an unprecedented lasix.

To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world. Thus, there are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable &. Sons Metal Products, Inc. V.

Darue Eng'g. &. Mf'g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party's exclusive remedy is an administrative Start Printed Page 79198remedy under section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.[] XII. Effective Time Period 42 U.S.C.

247d-6d(b)(2)(B) Liability protections for any respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, through the means of distribution identified in Section VII(a) of this Declaration, begin on March 27, 2020 and extend through October 1, 2024. Liability protections for all other Covered Countermeasures identified in Section VI of this Declaration, through means of distribution identified in Section VII(a) of this Declaration, begin on February 4, 2020 and extend through October 1, 2024. Liability protections for all Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, as identified in Section VII(b) of this Declaration, begin with a Declaration of Emergency as that term is defined in Section VII (except that, with respect to qualified persons who order or administer a routine childhood vaccination that ACIP recommends to persons ages three through 18 according to ACIP's standard immunization schedule, liability protections began on August 24, 2020), and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first. Liability protections for all Covered Countermeasures identified in Section VII(c) of this Declaration begin on the date of this amended Declaration and last through (a) the final day the Declaration of Emergency is in effect, or (b) October 1, 2024, whichever occurs first.

XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C) I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.

Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/​cicp/​. XV. Amendments 42 U.S.C. 247d-6d(b)(4) Amendments to this Declaration will be published in the Federal Register, as warranted.

Start Authority 42 U.S.C. 247d-6d. End Authority Start Signature Dated. December 3, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc. 2020-26977 Filed 12-8-20.

How long should you take lasix

SALT LAKE how long should you take lasix cheap lasix pills CITY, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Health Catalyst, Inc. (Nasdaq. HCAT), a leading provider of data and analytics technology and services to healthcare organizations, today reported financial results for the quarter ended September 30, 2020.“In the third quarter of 2020, I am pleased to share that we achieved strong performance across our business, including exceeding the mid-point of our quarterly guidance for both revenue and Adjusted EBITDA,” said Dan Burton, CEO of Health Catalyst.

€œIn addition to this financial and operational execution, we are excited to announce the promotion of Patrick Nelli, our current Chief Financial Officer, to the role President of Health Catalyst, effective January 1, 2021. Patrick's responsibilities as President will include all the major growth functions of the company, including with existing customers, new customers, international expansion, sales operations, marketing and communications. Additionally, I am pleased to announce the promotion of Bryan Hunt, our current Senior Vice President of Financial Planning &. Analysis to the role of Chief Financial Officer, effective January 1, 2021.

Patrick and Bryan, in their newly appointed roles, have my full support and confidence and the unanimous support and confidence of our board of directors. Lastly, I would also like to share two additional promotions related to these changes. Jason Alger, our Senior Vice President of Finance, has been promoted to Chief Accounting Officer, and Adam Brown, our Senior Vice President of Investor Relations, has been promoted to Senior Vice President of Investor Relations and Finance Planning &. Analysis.”Financial Highlights for the Three Months Ended September 30, 2020 Key Financial Metrics Three Months EndedSeptember 30, Year over Year Change 2020 2019 GAAP Financial Data.

(in thousands, except percentages) Technology revenue $ 27,964 $ 21,160 32% Professional services revenue $ 19,227 $ 18,263 5% Total revenue $ 47,191 $ 39,423 20% Loss from operations $ (23,458 ) $ (20,736 ) (13)% Net loss $ (27,326 ) $ (21,416 ) (28)% Other Non-GAAP Financial Data:(1) Adjusted Technology Gross Profit $ 19,115 $ 14,484 32% Adjusted Technology Gross Margin 68 % 68 % Adjusted Professional Services Gross Profit $ 4,823 $ 6,677 (28)% Adjusted Professional Services Gross Margin 25 % 37 % Total Adjusted Gross Profit $ 23,938 $ 21,161 13% Total Adjusted Gross Margin 51 % 54 % Adjusted EBITDA $ (6,434 ) $ (8,446 ) 24% ________________________(1) These measures are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). See the accompanying "Non-GAAP Financial Measures" section below for more information about these financial measures, including the limitations of such measures, and for a reconciliation of each measure to the most directly comparable measure calculated in accordance with GAAP.Financial OutlookHealth Catalyst provides forward-looking guidance on total revenue, a GAAP measure, and Adjusted EBITDA, a non-GAAP measure.For the fourth quarter of 2020, we expect:Total revenue between $50.5 million and $53.5 million, and Adjusted EBITDA between $(7.3) million and $(5.3) millionFor the full year of 2020, we expect:Total revenue between $186.1 million and $189.1 million, and Adjusted EBITDA between $(23.9) million and $(21.9) millionWe have not reconciled guidance for Adjusted EBITDA to net loss, the most directly comparable GAAP measure, and have not provided forward-looking guidance for net loss, because there are items that may impact net loss, including stock-based compensation, that are not within our control or cannot be reasonably predicted.Quarterly Conference Call DetailsThe company will host a conference call to review the results today, Tuesday, November 10, 2020 at 5:00 p.m. E.T. The conference call can be accessed by dialing 1-877-295-1104 for U.S.

Participants, or 1-470-495-9486 for international participants, and referencing participant code 7195951. A live audio webcast will be available online at https://ir.healthcatalyst.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call, at the same web link, and will remain available for approximately 90 days.About Health CatalystHealth Catalyst is a leading provider of data and analytics technology and services to healthcare organizations committed to being the catalyst for massive, measurable, data-informed healthcare improvement. Its customers leverage the cloud-based data platform—powered by data from more than 100 million patient records and encompassing trillions of facts—as well as its analytics software and professional services expertise to make data-informed decisions and realize measurable clinical, financial, and operational improvements.

Health Catalyst envisions a future in which all healthcare decisions are data informed.Available InformationHealth Catalyst intends to use its Investor Relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.Forward-Looking StatementsThis release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements include statements regarding our future growth and our financial outlook for Q4 and fiscal year 2020. Forward-looking statements are subject to risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results may differ materially from the results predicted, and reported results should not be considered as an indication of future performance.Important risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following.

(i) changes in laws and regulations applicable to our business model. (ii) changes in market or industry conditions, regulatory environment and receptivity to our technology and services. (iii) results of litigation or a security incident. (iv) the loss of one or more key customers or partners.

(v) the impact of hypertension medications on our business and results of operation. And (vi) changes to our abilities to recruit and retain qualified team members. For a detailed discussion of the risk factors that could affect our actual results, please refer to the risk factors identified in our SEC reports, including, but not limited to the Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 28, 2020 and the Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 expected to be filed with the SEC on or about November 10, 2020. All information provided in this release and in the attachments is as of the date hereof, and we undertake no duty to update or revise this information unless required by law.

Condensed Consolidated Balance Sheets (in thousands, except share and per share data, unaudited) As ofSeptember 30, As ofDecember 31, 2020 2019 Assets Current assets. Cash and cash equivalents $ 111,239 $ 18,032 Short-term investments 163,898 210,245 Accounts receivable, net 36,339 27,570 Prepaid expenses and other assets 11,290 8,392 Total current assets 322,766 264,239 Property and equipment, net 5,319 4,295 Intangible assets, net 105,926 25,535 Operating lease right-of-use assets 25,833 3,787 Goodwill 107,822 3,694 Other assets 2,997 810 Total assets $ 570,663 $ 302,360 Liabilities and stockholders’ equity Current liabilities. Accounts payable $ 5,189 $ 3,622 Accrued liabilities 14,061 8,944 Acquisition-related consideration payable 3,214 2,192 Deferred revenue 35,090 30,653 Operating lease liabilities 2,425 2,806 Contingent consideration liabilities 5,893 — Total current liabilities 65,872 48,217 Long-term debt, net of current portion 166,200 48,200 Acquisition-related consideration payable, net of current portion — 1,860 Deferred revenue, net of current portion 1,635 1,459 Operating lease liabilities, net of current portion 24,245 1,654 Contingent consideration liabilities, net of current portion 10,279 — Other liabilities 2,817 326 Total liabilities 271,048 101,716 Commitments and contingencies Stockholders’ equity. Common stock, $0.001 par value.

42,239,922 and 36,678,854 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 42 37 Additional paid-in capital 982,139 811,049 Accumulated deficit (682,632 ) (610,514 ) Accumulated other comprehensive income 66 72 Total stockholders' equity 299,615 200,644 Total liabilities and stockholders’ equity $ 570,663 $ 302,360 Condensed Consolidated Statements of Operations (in thousands, except per share data, unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Revenue. Technology $ 27,964 $ 21,160 $ 78,150 $ 61,393 Professional services 19,227 18,263 57,416 50,047 Total revenue 47,191 39,423 135,566 111,440 Cost of revenue, excluding depreciation and amortization. Technology(1) 9,045 6,740 25,148 20,536 Professional services(1)(3) 15,307 11,892 46,401 33,132 Total cost of revenue, excluding depreciation and amortization 24,352 18,632 71,549 53,668 Operating expenses. Sales and marketing(1)(3) 14,629 14,721 40,618 35,579 Research and development(1)(3) 13,390 13,477 38,539 33,209 General and administrative(1)(2)(4)(5) 13,297 11,013 31,111 23,333 Depreciation and amortization 4,981 2,316 10,952 6,844 Total operating expenses 46,297 41,527 121,220 98,965 Loss from operations (23,458 ) (20,736 ) (57,203 ) (41,193 ) Loss on extinguishment of debt — — (8,514 ) (1,670 ) Interest and other expense, net (3,854 ) (659 ) (7,500 ) (2,924 ) Loss before income taxes (27,312 ) (21,395 ) (73,217 ) (45,787 ) Income tax provision (benefit) 14 21 (1,218 ) 43 Net loss $ (27,326 ) $ (21,416 ) $ (71,999 ) $ (45,830 ) Less.

Accretion of redeemable convertible preferred stock — 18,170 — 180,826 Net loss attributable to common stockholders $ (27,326 ) $ (39,586 ) $ (71,999 ) $ (226,656 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.68 ) $ (1.40 ) $ (1.87 ) $ (17.78 ) Weighted-average shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted 40,292 28,223 38,517 12,750 Adjusted net loss(6) $ (8,287 ) $ (9,817 ) $ (20,110 ) $ (26,014 ) Pro forma adjusted net loss per share, basic and diluted(6) $ (0.21 ) $ (0.27 ) $ (0.52 ) $ (0.72 ) Pro forma as adjusted weighted-average number of shares outstanding used in calculating Adjusted Net Loss per share, basic and diluted(6) 40,292 36,373 38,517 36,183 _______________(1) Includes stock-based compensation expense as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Stock-Based Compensation Expense. (in thousands) (in thousands) Cost of revenue, excluding http://www.maine--coon.de/coonie-und-katzen-blog/ depreciation and amortization. Technology $ 196 $ 64 $ 575 $ 129 Professional services 903 306 2,609 593 Sales and marketing 3,233 1,358 9,724 2,639 Research and development 2,025 3,067 5,987 3,502 General and administrative 3,139 5,179 8,388 6,165 Total $ 9,496 $ 9,974 $ 27,283 $ 13,028 (2) Includes acquisition transaction costs as follows.

Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Acquisition transaction costs. (in thousands) (in thousands) General and administrative $ 1,399 $ — $ 2,670 $ — Total $ 1,399 $ — $ 2,670 $ — (3) Includes post-acquisition restructuring costs as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Post-Acquisition Restructuring Costs. (in thousands) (in thousands) Cost of revenue, excluding depreciation and amortization.

Professional services $ — $ — $ — $ 108 Sales and marketing — — — 306 Research and development — — — 32 Total $ — $ — $ — $ 446 (4) Includes the change in fair value of contingent consideration liabilities, as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Change in fair value of contingent consideration liabilities. (in thousands) (in thousands) General and administrative $ 564 $ — $ (1,004 ) $ — Total $ 564 $ — $ (1,004 ) $ — (5) Includes duplicate headquarters rent expense, as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Duplicate Headquarters Rent Expense.

(in thousands) (in thousands) General and administrative $ 584 $ — $ 709 $ — Total $ 584 $ — $ 709 $ — (6) Includes pro forma adjustments to net loss attributable to common stockholders and the weighted average number of common shares outstanding directly attributable to the closing of our initial public offering on July 29, 2019 as well as certain other non-GAAP adjustments. Refer to the "Non-GAAP Financial Measures—Pro Forma Adjusted Net Loss Per Share" section below for further details. Condensed Consolidated Statements of Cash Flows (in thousands, unaudited) Nine Months EndedSeptember 30, Cash flows from operating activities 2020 2019 Net loss $ (71,999 ) $ (45,830 ) Adjustments to reconcile net loss to net cash used in operating activities. Depreciation and amortization 10,952 6,844 Loss on extinguishment of debt 8,514 1,670 Amortization of debt discount and issuance costs 5,260 797 Non-cash operating lease expense 2,865 2,696 Investment discount and premium amortization 854 (443 ) Provision for expected credit losses 822 — Stock-based compensation expense 27,283 13,028 Deferred tax (benefit) provision (1,280 ) — Change in fair value of contingent consideration liabilities (1,004 ) — Other 85 (36 ) Change in operating assets and liabilities.

Accounts receivable, net (4,450 ) (3,323 ) Prepaid expenses and other assets (2,937 ) (1,362 ) Accounts payable, accrued liabilities, and other liabilities 6,567 1,661 Deferred revenue (838 ) 7,601 Operating lease liabilities (2,701 ) (2,426 ) Net cash used in operating activities (22,007 ) (19,123 ) Cash flows from investing activities Purchase of short-term investments (163,346 ) (221,444 ) Proceeds from the sale and maturity of short-term investments 208,467 37,277 Acquisition of businesses, net of cash acquired (102,471 ) — Purchase of property and equipment (2,071 ) (1,658 ) Purchase of intangible assets (1,249 ) (1,747 ) Proceeds from sale of property and equipment 10 40 Net cash used in investing activities (60,660 ) (187,532 ) Cash flows from financing activities Proceeds from convertible note securities, net of issuance costs 222,482 — Purchase of capped calls concurrent with issuance of convertible senior notes (21,743 ) — Proceeds from credit facilities, net of debt issuance costs — 47,169 Repayment of credit facilities (57,043 ) (21,821 ) Proceeds from exercise of stock options 29,393 2,177 Proceeds from employee stock purchase plan 3,528 1,216 Payments of acquisition-related consideration (748 ) (773 ) Proceeds from initial public offering, net of underwriters’ discounts and commissions — 194,649 Proceeds from the issuance of redeemable convertible preferred stock, net of issuance costs — 12,073 Payments of deferred offering costs — (4,407 ) Net cash provided by financing activities 175,869 230,283 Effect of exchange rate on cash and cash equivalents 5 — Net increase in cash and cash equivalents 93,207 23,628 Cash and cash equivalents at beginning of period 18,032 28,431 Cash and cash equivalents at end of period $ 111,239 $ 52,059 Non-GAAP Financial MeasuresTo supplement our financial information presented in accordance with GAAP, we believe certain non-GAAP measures, including Adjusted Gross Profit, Adjusted Gross Margin, Adjusted EBITDA, Adjusted Net Loss, and Adjusted Net Loss per share, basic and diluted, are useful in evaluating our operating performance. We use this non-GAAP financial information to evaluate our ongoing operations, as a component in determining employee bonus compensation, and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP.

In addition, other companies, including companies in our industry, may calculate similarly-titled non-GAAP measures differently or may use other measures to evaluate their performance. A reconciliation is provided below for each non-GAAP financial measure to the most directly comparable financial measure stated in accordance with GAAP. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business.Adjusted Gross Profit and Adjusted Gross MarginAdjusted Gross Profit is a non-GAAP financial measure that we define as revenue less cost of revenue, excluding depreciation and amortization and excluding (i) stock-based compensation and (ii) post-acquisition restructuring costs (none during periods presented). We define Adjusted Gross Margin as our Adjusted Gross Profit divided by our revenue.

We believe Adjusted Gross Profit and Adjusted Gross Margin are useful to investors as they eliminate the impact of certain non-cash expenses and allow a direct comparison of these measures between periods without the impact of non-cash expenses and certain other non-recurring operating expenses. The following is a reconciliation of revenue, the most directly comparable GAAP financial measure, to Adjusted Gross Profit, for the three months ended September 30, 2020 and 2019. Three Months Ended September 30, 2020 (in thousands, except percentages) Technology Professional Services Total Revenue $ 27,964 $ 19,227 $ 47,191 Cost of revenue, excluding depreciation and amortization (9,045 ) (15,307 ) (24,352 ) Gross profit, excluding depreciation and amortization 18,919 3,920 22,839 Add. Stock-based compensation 196 903 1,099 Adjusted Gross Profit $ 19,115 $ 4,823 $ 23,938 Gross margin, excluding depreciation and amortization 68 % 20 % 48 % Adjusted Gross Margin 68 % 25 % 51 % Three Months Ended September 30, 2019 (in thousands, except percentages) Technology Professional Services Total Revenue $ 21,160 $ 18,263 $ 39,423 Cost of revenue, excluding depreciation and amortization (6,740 ) (11,892 ) (18,632 ) Gross profit, excluding depreciation and amortization 14,420 6,371 20,791 Add.

Stock-based compensation 64 306 370 Adjusted Gross Profit $ 14,484 $ 6,677 $ 21,161 Gross margin, excluding depreciation and amortization 68 % 35 % 53 % Adjusted Gross Margin 68 % 37 % 54 % Adjusted EBITDAAdjusted EBITDA is a non-GAAP financial measure that we define as net loss adjusted for (i) interest and other expense, net, (ii) loss on extinguishment of debt (none in periods presented), (iii) income tax (benefit) provision, (iv) depreciation and amortization, (v) stock-based compensation, (vi) acquisition transaction costs, (vii) change in fair value of contingent consideration liability, (viii) duplicate headquarters rent expense, and (ix) post-acquisition restructuring costs when they are incurred. We believe Adjusted EBITDA provides investors with useful information on period-to-period performance as evaluated by management and comparison with our past financial performance and is useful in evaluating our operating performance compared to that of other companies in our industry, as this metric generally eliminates the effects of certain items that may vary from company to company for reasons unrelated to overall operating performance. The following is a reconciliation of our net loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA, for the three months ended September 30, 2020 and 2019. Three Months EndedSeptember 30, 2020 2019 (in thousands) Net loss $ (27,326 ) $ (21,416 ) Add.

Interest and other expense, net 3,854 659 Income tax (benefit) provision 14 21 Depreciation and amortization 4,981 2,316 Stock-based compensation 9,496 9,974 Acquisition transaction costs 1,399 — Change in fair value of contingent consideration liability 564 — Duplicate headquarters rent expense 584 — Adjusted EBITDA $ (6,434 ) $ (8,446 ) Pro Forma Adjusted Net Loss Per ShareAdjusted Net Loss is a non-GAAP financial measure that we define as net loss attributable to common stockholders adjusted for (i) accretion of redeemable convertible preferred stock, (ii) stock-based compensation, (iii) amortization of acquired intangibles, (iv) loss on debt extinguishment, (v) acquisition transaction costs, (vi) change in fair value of contingent consideration liability, (vii) non-cash interest expense related to our convertible senior notes, (viii) duplicate headquarters rent expense (see explanation above), and (ix) post-acquisition restructuring costs. Non-cash interest expense related to our convertible senior notes relates to the convertible senior notes that were issued in a private placement in April 2020. Under GAAP, we are required to separately account for liability (debt) and equity (conversion option) components of the convertible senior notes. Accordingly, for GAAP purposes we are required to recognize the effective interest expense on our convertible senior notes and amortize the issuance costs over the term of the notes.

The difference between the effective interest expense and the contractual interest expense, and the amortization expense of issuance costs are excluded from management’s assessment of our operating performance because management believes that these non-cash expenses are not indicative of ongoing operating performance.We believe Adjusted Net Loss provides investors with useful information on period-to-period performance as evaluated by management and comparison with our past financial performance and is useful in evaluating our operating performance compared to that of other companies in our industry, as this metric generally eliminates the effects of certain items that may vary from company to company for reasons unrelated to overall operating performance.On July 29, 2019, we closed our initial public offering (our IPO) in which we issued and sold 8,050,000 shares (inclusive of the underwriters’ option to purchase an additional 1,050,000 shares) of common stock at $26.00 per share. We received net proceeds of $194.6 million after deducting underwriting discounts and commissions and before deducting offering costs of $4.6 million. Upon the closing of our IPO, all shares of our outstanding redeemable convertible preferred stock converted into 23,151,481 shares of common stock on a one-for-one basis. We have prepared the below adjusted condensed consolidated statement of operations data to present pro forma adjusted net loss per share amounts that will be comparable between the current and prior periods presented as if the conversion of all outstanding shares of redeemable convertible preferred stock and the issuance of the IPO shares had occurred as of the beginning of the prior year comparative periods.

Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Numerator. (in thousands, except share and per share amounts) Net loss attributable to common stockholders $ (27,326 ) $ (39,586 ) $ (71,999 ) $ (226,656 ) Add Accretion of redeemable convertible preferred stock — 18,170 — 180,826 Stock-based compensation 9,496 9,974 27,283 13,028 Amortization of acquired intangibles 4,276 1,625 8,786 4,672 Loss on extinguishment of debt — — 8,514 1,670 Acquisition transaction costs 1,399 — 2,670 — Change in fair value of contingent consideration liability 564 — (1,004 ) — Non-cash interest expense related to convertible senior notes 2,720 — 4,931 — Duplicate headquarters rent expense 584 — 709 — Post-acquisition restructuring costs — — — 446 Adjusted Net Loss $ (8,287 ) $ (9,817 ) $ (20,110 ) $ (26,014 ) Denominator. Weighted-average number of shares used in calculating net loss per share attributable to common stockholders, basic and diluted 40,292,380 28,222,555 38,517,272 12,749,903 Pro forma adjustments Pro forma adjustment to reflect issuance and conversion of redeemable convertible preferred stock to common stock, assuming the conversion took place as of the beginning of the 2019 period — 6,039,517 — 17,384,812 Pro forma adjustment to reflect issuance of shares of common stock as part of IPO, assuming the issuance took place as of the beginning of the 2019 period — 2,111,413 — 6,048,718 Pro forma as adjusted weighted-average number of shares used in calculating Adjusted Net Loss per share, basic and diluted 40,292,380 36,373,485 38,517,272 36,183,433 Pro forma adjusted net loss per share, basic and diluted $ (0.21 ) $ (0.27 ) $ (0.52 ) $ (0.72 ) Health Catalyst Investor Relations Contact:Adam BrownSenior Vice President, Investor Relations+1 (855)-309-6800ir@healthcatalyst.comHealth Catalyst Media Contact:Amanda Hundtamanda.hundt@healthcatalyst.com+1 (575) 491-0974 Source. Health Catalyst, Inc..

SALT LAKE CITY, Nov where to buy lasix online. 10, 2020 (GLOBE NEWSWIRE) -- Health Catalyst, Inc. (Nasdaq. HCAT), a leading provider of data and analytics technology and services to healthcare organizations, today reported financial results for the quarter ended September 30, 2020.“In the third quarter of 2020, I am pleased to share that we achieved strong performance across our business, including exceeding the mid-point of our quarterly guidance for both revenue and Adjusted EBITDA,” said Dan Burton, CEO of Health Catalyst. €œIn addition to this financial and operational execution, we are excited to announce the promotion of Patrick Nelli, our current Chief Financial Officer, to the role President of Health Catalyst, effective January 1, 2021.

Patrick's responsibilities as President will include all the major growth functions of the company, including with existing customers, new customers, international expansion, sales operations, marketing and communications. Additionally, I am pleased to announce the promotion of Bryan Hunt, our current Senior Vice President of Financial Planning &. Analysis to the role of Chief Financial Officer, effective January 1, 2021. Patrick and Bryan, in their newly appointed roles, have my full support and confidence and the unanimous support and confidence of our board of directors. Lastly, I would also like to share two additional promotions related to these changes.

Jason Alger, our Senior Vice President of Finance, has been promoted to Chief Accounting Officer, and Adam Brown, our Senior Vice President of Investor Relations, has been promoted to Senior Vice President of Investor Relations and Finance Planning &. Analysis.”Financial Highlights for the Three Months Ended September 30, 2020 Key Financial Metrics Three Months EndedSeptember 30, Year over Year Change 2020 2019 GAAP Financial Data. (in thousands, except percentages) Technology revenue $ 27,964 $ 21,160 32% Professional services revenue $ 19,227 $ 18,263 5% Total revenue $ 47,191 $ 39,423 20% Loss from operations $ (23,458 ) $ (20,736 ) (13)% Net loss $ (27,326 ) $ (21,416 ) (28)% Other Non-GAAP Financial Data:(1) Adjusted Technology Gross Profit $ 19,115 $ 14,484 32% Adjusted Technology Gross Margin 68 % 68 % Adjusted Professional Services Gross Profit $ 4,823 $ 6,677 (28)% Adjusted Professional Services Gross Margin 25 % 37 % Total Adjusted Gross Profit $ 23,938 $ 21,161 13% Total Adjusted Gross Margin 51 % 54 % Adjusted EBITDA $ (6,434 ) $ (8,446 ) 24% ________________________(1) These measures are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). See the accompanying "Non-GAAP Financial Measures" section below for more information about these financial measures, including the limitations of such measures, and for a reconciliation of each measure to the most directly comparable measure calculated in accordance with GAAP.Financial OutlookHealth Catalyst provides forward-looking guidance on total revenue, a GAAP measure, and Adjusted EBITDA, a non-GAAP measure.For the fourth quarter of 2020, we expect:Total revenue between $50.5 million and $53.5 million, and Adjusted EBITDA between $(7.3) million and $(5.3) millionFor the full year of 2020, we expect:Total revenue between $186.1 million and $189.1 million, and Adjusted EBITDA between $(23.9) million and $(21.9) millionWe have not reconciled guidance for Adjusted EBITDA to net loss, the most directly comparable GAAP measure, and have not provided forward-looking guidance for net loss, because there are items that may impact net loss, including stock-based compensation, that are not within our control or cannot be reasonably predicted.Quarterly Conference Call DetailsThe company will host a conference call to review the results today, Tuesday, November 10, 2020 at 5:00 p.m. E.T.

The conference call can be accessed by dialing 1-877-295-1104 for U.S. Participants, or 1-470-495-9486 for international participants, and referencing participant code 7195951. A live audio webcast will be available online at https://ir.healthcatalyst.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call, at the same web link, and will remain available for approximately 90 days.About Health CatalystHealth Catalyst is a leading provider of data and analytics technology and services to healthcare organizations committed to being the catalyst for massive, measurable, data-informed healthcare improvement. Its customers leverage the cloud-based data platform—powered by data from more than 100 million patient records and encompassing trillions of facts—as well as its analytics software and professional services expertise to make data-informed decisions and realize measurable clinical, financial, and operational improvements.

Health Catalyst envisions a future in which all healthcare decisions are data informed.Available InformationHealth Catalyst intends to use its Investor Relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.Forward-Looking StatementsThis release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements include statements regarding our future growth and our financial outlook for Q4 and fiscal year 2020. Forward-looking statements are subject to risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results may differ materially from the results predicted, and reported results should not be considered as an indication of future performance.Important risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following. (i) changes in laws and regulations applicable to our business model.

(ii) changes in market or industry conditions, regulatory environment and receptivity to our technology and services. (iii) results of litigation or a security incident. (iv) the loss of one or more key customers or partners. (v) the impact of hypertension medications on our business and results of operation. And (vi) changes to our abilities to recruit and retain qualified team members.

For a detailed discussion of the risk factors that could affect our actual results, please refer to the risk factors identified in our SEC reports, including, but not limited to the Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 28, 2020 and the Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 expected to be filed with the SEC on or about November 10, 2020. All information provided in this release and in the attachments is as of the date hereof, and we undertake no duty to update or revise this information unless required by law. Condensed Consolidated Balance Sheets (in thousands, except share and per share data, unaudited) As ofSeptember 30, As ofDecember 31, 2020 2019 Assets Current assets. Cash and cash equivalents $ 111,239 $ 18,032 Short-term investments 163,898 210,245 Accounts receivable, net 36,339 27,570 Prepaid expenses and other assets 11,290 8,392 Total current assets 322,766 264,239 Property and equipment, net 5,319 4,295 Intangible assets, net 105,926 25,535 Operating lease right-of-use assets 25,833 3,787 Goodwill 107,822 3,694 Other assets 2,997 810 Total assets $ 570,663 $ 302,360 Liabilities and stockholders’ equity Current liabilities. Accounts payable $ 5,189 $ 3,622 Accrued liabilities 14,061 8,944 Acquisition-related consideration payable 3,214 2,192 Deferred revenue 35,090 30,653 Operating lease liabilities 2,425 2,806 Contingent consideration liabilities 5,893 — Total current liabilities 65,872 48,217 Long-term debt, net of current portion 166,200 48,200 Acquisition-related consideration payable, net of current portion — 1,860 Deferred revenue, net of current portion 1,635 1,459 Operating lease liabilities, net of current portion 24,245 1,654 Contingent consideration liabilities, net of current portion 10,279 — Other liabilities 2,817 326 Total liabilities 271,048 101,716 Commitments and contingencies Stockholders’ equity.

Common stock, $0.001 par value. 42,239,922 and 36,678,854 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 42 37 Additional paid-in capital 982,139 811,049 Accumulated deficit (682,632 ) (610,514 ) Accumulated other comprehensive income 66 72 Total stockholders' equity 299,615 200,644 Total liabilities and stockholders’ equity $ 570,663 $ 302,360 Condensed Consolidated Statements of Operations (in thousands, except per share data, unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Revenue. Technology $ 27,964 $ 21,160 $ 78,150 $ 61,393 Professional services 19,227 18,263 57,416 50,047 Total revenue 47,191 39,423 135,566 111,440 Cost of revenue, excluding depreciation and amortization. Technology(1) 9,045 6,740 25,148 20,536 Professional services(1)(3) 15,307 11,892 46,401 33,132 Total cost of revenue, excluding depreciation and amortization 24,352 18,632 71,549 53,668 Operating expenses. Sales and marketing(1)(3) 14,629 14,721 40,618 35,579 Research and development(1)(3) 13,390 13,477 38,539 33,209 General and administrative(1)(2)(4)(5) 13,297 11,013 31,111 23,333 Depreciation and amortization 4,981 2,316 10,952 6,844 Total operating expenses 46,297 41,527 121,220 98,965 Loss from operations (23,458 ) (20,736 ) (57,203 ) (41,193 ) Loss on extinguishment of debt — — (8,514 ) (1,670 ) Interest and other expense, net (3,854 ) (659 ) (7,500 ) (2,924 ) Loss before income taxes (27,312 ) (21,395 ) (73,217 ) (45,787 ) Income tax provision (benefit) 14 21 (1,218 ) 43 Net loss $ (27,326 ) $ (21,416 ) $ (71,999 ) $ (45,830 ) Less.

Accretion of redeemable convertible preferred stock — 18,170 — 180,826 Net loss attributable to common stockholders $ (27,326 ) $ (39,586 ) $ (71,999 ) $ (226,656 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.68 ) $ (1.40 ) $ (1.87 ) $ (17.78 ) Weighted-average shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted 40,292 28,223 38,517 12,750 Adjusted net loss(6) $ (8,287 ) $ (9,817 ) $ (20,110 ) $ (26,014 ) Pro forma adjusted net loss per share, basic and diluted(6) $ (0.21 ) $ (0.27 ) $ (0.52 ) $ (0.72 ) Pro forma as adjusted weighted-average number of shares outstanding used in calculating Adjusted Net Loss per share, basic and diluted(6) 40,292 36,373 38,517 36,183 _______________(1) Includes stock-based compensation expense as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Stock-Based Compensation Expense. (in thousands) (in thousands) Cost of revenue, excluding depreciation and amortization. Technology $ 196 $ 64 $ 575 $ 129 Professional services 903 306 2,609 593 Sales and marketing 3,233 1,358 9,724 2,639 Research and development 2,025 3,067 5,987 3,502 General and administrative 3,139 5,179 8,388 6,165 Total $ 9,496 $ 9,974 $ 27,283 $ 13,028 (2) Includes acquisition transaction costs as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Acquisition transaction costs.

(in thousands) (in thousands) General and administrative $ 1,399 $ — $ 2,670 $ — Total $ 1,399 $ — $ 2,670 $ — (3) Includes post-acquisition restructuring costs as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Post-Acquisition Restructuring Costs. (in thousands) (in thousands) Cost of revenue, excluding depreciation and amortization. Professional services $ — $ — $ — $ 108 Sales and marketing — — — 306 Research and development — — — 32 Total $ — $ — $ — $ 446 (4) Includes the change in fair value of contingent consideration liabilities, as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Change in fair value of contingent consideration liabilities.

(in thousands) (in thousands) General and administrative $ 564 $ — $ (1,004 ) $ — Total $ 564 $ — $ (1,004 ) $ — (5) Includes duplicate headquarters rent expense, as follows. Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2020 2019 2020 2019 Duplicate Headquarters Rent Expense. (in thousands) (in thousands) General and administrative $ 584 $ — $ 709 $ — Total $ 584 $ — $ 709 $ — (6) Includes pro forma adjustments to net loss attributable to common stockholders and the weighted average number of common shares outstanding directly attributable to the closing of our initial public offering on July 29, 2019 as well as certain other non-GAAP adjustments. Refer to the "Non-GAAP Financial Measures—Pro Forma Adjusted Net Loss Per Share" section below for further details. Condensed Consolidated Statements of Cash Flows (in thousands, unaudited) Nine Months EndedSeptember 30, Cash flows from operating activities 2020 2019 Net loss $ (71,999 ) $ (45,830 ) Adjustments to reconcile net loss to net cash used in operating activities.

Depreciation and amortization 10,952 6,844 Loss on extinguishment of debt 8,514 1,670 Amortization of debt discount and issuance costs 5,260 797 Non-cash operating lease expense 2,865 2,696 Investment discount and premium amortization 854 (443 ) Provision for expected credit losses 822 — Stock-based compensation expense 27,283 13,028 Deferred tax (benefit) provision (1,280 ) — Change in fair value of contingent consideration liabilities (1,004 ) — Other 85 (36 ) Change in operating assets and liabilities. Accounts receivable, net (4,450 ) (3,323 ) Prepaid expenses and other assets (2,937 ) (1,362 ) Accounts payable, accrued liabilities, and other liabilities 6,567 1,661 Deferred revenue (838 ) 7,601 Operating lease liabilities (2,701 ) (2,426 ) Net cash used in operating activities (22,007 ) (19,123 ) Cash flows from investing activities Purchase of short-term investments (163,346 ) (221,444 ) Proceeds from the sale and maturity of short-term investments 208,467 37,277 Acquisition of businesses, net of cash acquired (102,471 ) — Purchase of property and equipment (2,071 ) (1,658 ) Purchase of intangible assets (1,249 ) (1,747 ) Proceeds from sale of property and equipment 10 40 Net cash used in investing activities (60,660 ) (187,532 ) Cash flows from financing activities Proceeds from convertible note securities, net of issuance costs 222,482 — Purchase of capped calls concurrent with issuance of convertible senior notes (21,743 ) — Proceeds from credit facilities, net of debt issuance costs — 47,169 Repayment of credit facilities (57,043 ) (21,821 ) Proceeds from exercise of stock options 29,393 2,177 Proceeds from employee stock purchase plan 3,528 1,216 Payments of acquisition-related consideration (748 ) (773 ) Proceeds from initial public offering, net of underwriters’ discounts and commissions — 194,649 Proceeds from the issuance of redeemable convertible preferred stock, net of issuance costs — 12,073 Payments of deferred offering costs — (4,407 ) Net cash provided by financing activities 175,869 230,283 Effect of exchange rate on cash and cash equivalents 5 — Net increase in cash and cash equivalents 93,207 23,628 Cash and cash equivalents at beginning of period 18,032 28,431 Cash and cash equivalents at end of period $ 111,239 $ 52,059 Non-GAAP Financial MeasuresTo supplement our financial information presented in accordance with GAAP, we believe certain non-GAAP measures, including Adjusted Gross Profit, Adjusted Gross Margin, Adjusted EBITDA, Adjusted Net Loss, and Adjusted Net Loss per share, basic and diluted, are useful in evaluating our operating performance. We use this non-GAAP financial information to evaluate our ongoing operations, as a component in determining employee bonus compensation, and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP.

In addition, other companies, including companies in our industry, may calculate similarly-titled non-GAAP measures differently or may use other measures to evaluate their performance. A reconciliation is provided below for each non-GAAP financial measure to the most directly comparable financial measure stated in accordance with GAAP. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, and not to rely on any single financial measure to evaluate our business.Adjusted Gross Profit and Adjusted Gross MarginAdjusted Gross Profit is a non-GAAP financial measure that we define as revenue less cost of revenue, excluding depreciation and amortization and excluding (i) stock-based compensation and (ii) post-acquisition restructuring costs (none during periods presented). We define Adjusted Gross Margin as our Adjusted Gross Profit divided by our revenue. We believe Adjusted Gross Profit and Adjusted Gross Margin are useful to investors as they eliminate the impact of certain non-cash expenses and allow a direct comparison of these measures between periods without the impact of non-cash expenses and certain other non-recurring operating expenses.

The following is a reconciliation of revenue, the most directly comparable GAAP financial measure, to Adjusted Gross Profit, for the three months ended September 30, 2020 and 2019. Three Months Ended September 30, 2020 (in thousands, except percentages) Technology Professional Services Total Revenue $ 27,964 $ 19,227 $ 47,191 Cost of revenue, excluding depreciation and amortization (9,045 ) (15,307 ) (24,352 ) Gross profit, excluding depreciation and amortization 18,919 3,920 22,839 Add. Stock-based compensation 196 903 1,099 Adjusted Gross Profit $ 19,115 $ 4,823 $ 23,938 Gross margin, excluding depreciation and amortization 68 % 20 % 48 % Adjusted Gross Margin 68 % 25 % 51 % Three Months Ended September 30, 2019 (in thousands, except percentages) Technology Professional Services Total Revenue $ 21,160 $ 18,263 $ 39,423 Cost of revenue, excluding depreciation and amortization (6,740 ) (11,892 ) (18,632 ) Gross profit, excluding depreciation and amortization 14,420 6,371 20,791 Add. Stock-based compensation 64 306 370 Adjusted Gross Profit $ 14,484 $ 6,677 $ 21,161 Gross margin, excluding depreciation and amortization 68 % 35 % 53 % Adjusted Gross Margin 68 % 37 % 54 % Adjusted EBITDAAdjusted EBITDA is a non-GAAP financial measure that we define as net loss adjusted for (i) interest and other expense, net, (ii) loss on extinguishment of debt (none in periods presented), (iii) income tax (benefit) provision, (iv) depreciation and amortization, (v) stock-based compensation, (vi) acquisition transaction costs, (vii) change in fair value of contingent consideration liability, (viii) duplicate headquarters rent expense, and (ix) post-acquisition restructuring costs when they are incurred. We believe Adjusted EBITDA provides investors with useful information on period-to-period performance as evaluated by management and comparison with our past financial performance and is useful in evaluating our operating performance compared to that of other companies in our industry, as this metric generally eliminates the effects of certain items that may vary from company to company for reasons unrelated to overall operating performance.

The following is a reconciliation of our net loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA, for the three months ended September 30, 2020 and 2019. Three Months EndedSeptember 30, 2020 2019 (in thousands) Net loss $ (27,326 ) $ (21,416 ) Add. Interest and other expense, net 3,854 659 Income tax (benefit) provision 14 21 Depreciation and amortization 4,981 2,316 Stock-based compensation 9,496 9,974 Acquisition transaction costs 1,399 — Change in fair value of contingent consideration liability 564 — Duplicate headquarters rent expense 584 — Adjusted EBITDA $ (6,434 ) $ (8,446 ) Pro Forma Adjusted Net Loss Per ShareAdjusted Net Loss is a non-GAAP financial measure that we define as net loss attributable to common stockholders adjusted for (i) accretion of redeemable convertible preferred stock, (ii) stock-based compensation, (iii) amortization of acquired intangibles, (iv) loss on debt extinguishment, (v) acquisition transaction costs, (vi) change in fair value of contingent consideration liability, (vii) non-cash interest expense related to our convertible senior notes, (viii) duplicate headquarters rent expense (see explanation above), and (ix) post-acquisition restructuring costs. Non-cash interest expense related to our convertible senior notes relates to the convertible senior notes that were issued in a private placement in April 2020. Under GAAP, we are required to separately account for liability (debt) and equity (conversion option) components of the convertible senior notes.

Accordingly, for GAAP purposes we are required to recognize the effective interest expense on our convertible senior notes and amortize the issuance costs over the term of the notes. The difference between the effective interest expense and the contractual interest expense, and the amortization expense of issuance costs are excluded from management’s assessment of our operating performance because management believes that these non-cash expenses are not indicative of ongoing operating performance.We believe Adjusted Net Loss provides investors with useful information on period-to-period performance as evaluated by management and comparison with our past financial performance and is useful in evaluating our operating performance compared to that of other companies in our industry, as this metric generally eliminates the effects of certain items that may vary from company to company for reasons unrelated to overall operating performance.On July 29, 2019, we closed our initial public offering (our IPO) in which we issued and sold 8,050,000 shares (inclusive of the underwriters’ option to purchase an additional 1,050,000 shares) of common stock at $26.00 per share. We received net proceeds of $194.6 million after deducting underwriting discounts and commissions and before deducting offering costs of $4.6 million. Upon the closing of our IPO, all shares of our outstanding redeemable convertible preferred stock converted into 23,151,481 shares of common stock on a one-for-one basis. We have prepared the below adjusted condensed consolidated statement of operations data to present pro forma adjusted net loss per share amounts that will be comparable between the current and prior periods presented as if the conversion of all outstanding shares of redeemable convertible preferred stock and the issuance of the IPO shares had occurred as of the beginning of the prior year comparative periods.

Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Numerator. (in thousands, except share and per share amounts) Net loss attributable to common stockholders $ (27,326 ) $ (39,586 ) $ (71,999 ) $ (226,656 ) Add Accretion of redeemable convertible preferred stock — 18,170 — 180,826 Stock-based compensation 9,496 9,974 27,283 13,028 Amortization of acquired intangibles 4,276 1,625 8,786 4,672 Loss on extinguishment of debt — — 8,514 1,670 Acquisition transaction costs 1,399 — 2,670 — Change in fair value of contingent consideration liability 564 — (1,004 ) — Non-cash interest expense related to convertible senior notes 2,720 — 4,931 — Duplicate headquarters rent expense 584 — 709 — Post-acquisition restructuring costs — — — 446 Adjusted Net Loss $ (8,287 ) $ (9,817 ) $ (20,110 ) $ (26,014 ) Denominator. Weighted-average number of shares used in calculating net loss per share attributable to common stockholders, basic and diluted 40,292,380 28,222,555 38,517,272 12,749,903 Pro forma adjustments Pro forma adjustment to reflect issuance and conversion of redeemable convertible preferred stock to common stock, assuming the conversion took place as of the beginning of the 2019 period — 6,039,517 — 17,384,812 Pro forma adjustment to reflect issuance of shares of common stock as part of IPO, assuming the issuance took place as of the beginning of the 2019 period — 2,111,413 — 6,048,718 Pro forma as adjusted weighted-average number of shares used in calculating Adjusted Net Loss per share, basic and diluted 40,292,380 36,373,485 38,517,272 36,183,433 Pro forma adjusted net loss per share, basic and diluted $ (0.21 ) $ (0.27 ) $ (0.52 ) $ (0.72 ) Health Catalyst Investor Relations Contact:Adam BrownSenior Vice President, Investor Relations+1 (855)-309-6800ir@healthcatalyst.comHealth Catalyst Media Contact:Amanda Hundtamanda.hundt@healthcatalyst.com+1 (575) 491-0974 Source. Health Catalyst, Inc..

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Contact the can lasix cause constipation FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email. FCC504@fcc.gov or phone. 202-418-0530 or can lasix cause constipation TTY. 202-418-0432. Start Further Info Michelle Sclater, michelle.sclater@fcc.gov or (202) 418-0388.

End Further Info End Preamble Start Supplemental Information On October 17, 2020, the President signed the National Suicide Hotline Designation Act of 2020 into law can lasix cause constipation (Suicide Hotline Act). The Suicide Hotline Act designates 988 as the universal telephone number within the United States for the purpose of the national suicide prevention and mental health crisis hotline system within one year after enactment of the Suicide Hotline Act. It also directs the Commission to submit a report on location identification. By this public notice, we seek comment on issues to inform the location identification report, which is due to Congress by can lasix cause constipation April 17, 2021. Section 5 of the Suicide Hotline Act requires the Commission to submit a report to the appropriate committees “that examines the feasibility and cost of including an automatic dispatchable location that would be conveyed with a 9-8-8 call, regardless of the technological platform used and including with calls from multi-line telephone systems,” and as such, we seek comment on these issues generally.

More specifically, what is the feasibility of including location information with a 988 call? can lasix cause constipation. What technical issues are involved and how can they be overcome, including with respect to multi-line telephone systems?. How long would an implementation process take?. What are the costs involved—both the financial costs can lasix cause constipation and any potential risks to consumer privacy or other non-monetary costs?. We note that in addition to soliciting written public comment by this Public Notice, we will invite members of our expert advisory committee, the North American Numbering Council, to discuss and provide input on the feasibility and cost of including an automatic dispatchable location with a 988 call at a forthcoming meeting.

We also take this opportunity to clarify the 988 implementation date, as well as the effective date of the designation of 988 as the universal telephone number within the can lasix cause constipation United States for the national suicide prevention and mental health crisis hotline. Prior to enactment of the Suicide Hotline Act, the Commission designated 988 as the universal telephone number within the United States for the national suicide prevention and mental health crisis hotline in a Report and Order released on July 17, 2020, and that became effective on October 16, 2020. (85 FR 57767 (Sept. 16, 2020)) can lasix cause constipation. The Report and Order also set an implementation date of July 16, 2022 for all telecommunications carriers, interconnected voice over internet Protocol (VoIP) providers, and one-way Start Printed Page 79015VoIP providers to make any network changes necessary to ensure that users can dial 988 to reach the Lifeline.

The Suicide can lasix cause constipation Hotline Act states that the 988 designation shall take effect one year after enactment, but is silent on implementation. The implementation deadline set forth in the Report and Order “to allow sufficient time—but no more time than necessary—for covered providers to meet the challenges of implementing 10-digit dialing in 87 area codes and of making necessary changes to their switches” therefore remains unchanged by the Suicide Hotline Act. Although the Suicide Hotline Act does not mention the Commission's earlier designation of 988 in the Report and Order, we construe Congress's independent designation of 988 in the Suicide Hotline Act as a ratification of the Commission's designation. Accordingly, the Report and Order is unaffected by the Suicide Hotline Act, except that we now clarify that the designation of 988 as the universal telephone number within the United States for the national suicide prevention and mental health crisis hotline will take effect on October can lasix cause constipation 17, 2021, which is one year after the date of enactment of the Suicide Hotline Act, and not on October 16, 2020. This clarification is necessary to make the Report and Order consistent with Congress's clear intent that designation become effective one year after the date of enactment, as stated in section 3 of the Suicide Hotline Act.

To the extent necessary, we hereby waive the October 16, 2020 effective date of the designation in the Report and Order can lasix cause constipation until one year after the date of enactment of the Suicide Hotline Act. This waiver is necessary to effectuate Congress's intent, and we are aware of no harm to the public interest that would be caused by adopting the effective date that Congress prescribed in the Suicide Hotline Act. The proceeding this Notice initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation can lasix cause constipation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation.

If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must can lasix cause constipation be filed consistent with rule 1.1206(b). In proceedings governed by rule 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with can lasix cause constipation the Commission's ex parte rules. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document.

Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR can lasix cause constipation 24121 (1998). Electronic Filers. Comments may be filed can lasix cause constipation electronically using the internet by accessing the ECFS. Http://apps.fcc.gov/​ecfs/​.

Paper Filers. Parties who can lasix cause constipation choose to file by paper must file an original and one copy of each filing. Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail can lasix cause constipation. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD can lasix cause constipation 20701. U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC can lasix cause constipation 20554. Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings.

This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of hypertension medications. See FCC Announces Closure of FCC Headquarters can lasix cause constipation Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020). Https://www.fcc.gov/​document/​fcc-closes-headquarters-open-window-and-changes-hand-delivery-policy. People with Disabilities. To request materials in accessible formats for people can lasix cause constipation with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer &.

Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY). Start Signature Federal Communications Commission can lasix cause constipation. Daniel Kahn, Associate Bureau Chief, Wireline Competition Bureau. End Signature End Supplemental Information [FR Doc. 2020-26917 Filed can lasix cause constipation 12-7-20.

8:45 am]BILLING CODE 6712-01-PNew research shows that deaths due to the mix of substance abuse and suicides known as “diseases of despair” declined slightly in 2018. But the mortality rates throughout can lasix cause constipation the Ohio Valley and Appalachian region are still higher than the national average. A report from the Appalachian Regional Commission found that overall mortality rates from diseases of despair, which include suicide, liver disease, and overdoses, decreased between 2017 and 2018 — the first decline since 2012. But the research, done by the Walsh Center for Rural Health Analysis and Center for Rural Health Research at East Tennessee State University, shows those mortality rates are still disproportionately higher for Appalachia compared to the rest of the United States. €œWhat’s interesting about this is how you define the decline,” can lasix cause constipation Michael Meit explained.

Meit is the director of research and programs at the Center for Rural Health Research at ETSU and an author of the report. He said that the region’s diseases can lasix cause constipation of despair mortality rate only decreased by one percentage point. €œIn 2015, diseases of despair as a group was 37% higher in the Appalachian region compared to the rest of the nation and now 2018 data shows it’s 36% higher.” By using the Centers for Disease Control and Prevention mortality rates, researchers are able to keep track of what’s happening in the region. 2018 is the most recent data on record. What Meit found most interesting is the profile shift of the types of deaths within the can lasix cause constipation region.

€œWhere things changed is that the disparity in overdose went down considerably from 65 % higher to 48% higher,” Meit explained. €œBut that was then balanced out by suicide which went from 20% higher to 30% higher and alcohol liver disease which went from 8% higher to 13% higher.” He said the decline can lasix cause constipation in diseases of despair mortality could be driven by a shift from opioid use to methamphetamines and the decline of overdose deaths.“It’s easy to overdose on opioids, particularly when fentanyl came around. That led to the spike in overdose mortality. Methamphetamine does not typically lead to fatal overdose unless it is spiked with fentanyl or something else,” Meit said.As a whole, there are still major challenges in diseases of despair within the region.The diseases of despair mortality rate among 25 to 54-year-olds in Appalachia was 43% higher than the rest of the nation and disparities among women were larger in 2018 compared to the rest of the country.ARC Federal Co-Chairman Tim Thomas said in a press release that the Appalachian region still needs support. €œThis report highlights why ARC’s economic development efforts are so critical when it comes to addressing issues like substance abuse,” Thomas said.Researchers are can lasix cause constipation anticipating the impacts of the hypertension lasix may have on disease of despair mortality rates in the future.

The reports notes that “the impact of hypertension medications will likely lead to an increase in mortality from disease of despair, particularly as the Appalachian region and the rest of the United States experience economic challenges as a result of the lasix, isolation, and limitations on access to in-person treatment and recovery support.” Meit said anecdotal evidence suggests that there could be an increase in overdose deaths in 2020. That data won’t be available until late 2021 or 2022..

Start Preamble Federal where to buy lasix online browse around here Communications Commission Notice. The National Suicide Hotline Designation Act of 2020 (Suicide Hotline Act) designates 988 as the universal telephone number within the United States for the purpose of the national suicide prevention and mental health crisis hotline system within one year after enactment of the Suicide Hotline Act. It also directs the Federal Communications Commission to submit a report on location where to buy lasix online identification. This public notice seeks comment on issues to inform the location identification report, which is due to Congress by April 17, 2021.

This Public Notice also clarifies that the designation of 988 as the universal telephone number within the United States for the national suicide prevention and mental health crisis hotline will take effect on October 17, 2021, which is one year after the date of enactment of the Suicide Hotline Act, and not on October 16, 2020. Comments are due on or before December where to buy lasix online 21, 2020 and Reply Comments are due on or before January 11, 2021. You may submit comments, identified by WC Docket No. 18-336, by where to buy lasix online any of the following methods.

Federal Communications Commission's website. Http://apps.fcc.gov/​ecfs/​. Follow the where to buy lasix online instructions for submitting comments. Mail.

Federal Communications Commission, where to buy lasix online 45 L St. NE, Washington, DC 20554. People with Disabilities. Contact the where to buy lasix online FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email.

FCC504@fcc.gov or phone. 202-418-0530 or TTY where to buy lasix online. 202-418-0432. Start Further Info Michelle Sclater, michelle.sclater@fcc.gov or (202) 418-0388.

End Further Info End Preamble Start Supplemental Information On October 17, 2020, the President signed where to buy lasix online the National Suicide Hotline Designation Act of 2020 into law (Suicide Hotline Act). The Suicide Hotline Act designates 988 as the universal telephone number within the United States for the purpose of the national suicide prevention and mental health crisis hotline system within one year after enactment of the Suicide Hotline Act. It also directs the Commission to submit a report on location identification. By this public notice, we seek comment on issues to inform the location identification report, where to buy lasix online which is due to Congress by April 17, 2021.

Section 5 of the Suicide Hotline Act requires the Commission to submit a report to the appropriate committees “that examines the feasibility and cost of including an automatic dispatchable location that would be conveyed with a 9-8-8 call, regardless of the technological platform used and including with calls from multi-line telephone systems,” and as such, we seek comment on these issues generally. More specifically, what is the feasibility of including location information with where to buy lasix online a 988 call?. What technical issues are involved and how can they be overcome, including with respect to multi-line telephone systems?. How long would an implementation process take?.

What are the costs involved—both the financial where to buy lasix online costs and any potential risks to consumer privacy or other non-monetary costs?. We note that in addition to soliciting written public comment by this Public Notice, we will invite members of our expert advisory committee, the North American Numbering Council, to discuss and provide input on the feasibility and cost of including an automatic dispatchable location with a 988 call at a forthcoming meeting. We also take this opportunity to clarify the 988 implementation date, as well as the effective date of the designation of where to buy lasix online 988 as the universal telephone number within the United States for the national suicide prevention and mental health crisis hotline. Prior to enactment of the Suicide Hotline Act, the Commission designated 988 as the universal telephone number within the United States for the national suicide prevention and mental health crisis hotline in a Report and Order released on July 17, 2020, and that became effective on October 16, 2020.

(85 FR 57767 (Sept. 16, 2020)) where to buy lasix online. The Report and Order also set an implementation date of July 16, 2022 for all telecommunications carriers, interconnected voice over internet Protocol (VoIP) providers, and one-way Start Printed Page 79015VoIP providers to make any network changes necessary to ensure that users can dial 988 to reach the Lifeline. The Suicide Hotline Act states that the 988 designation shall take effect one year after enactment, where to buy lasix online but is silent on implementation.

The implementation deadline set forth in the Report and Order “to allow sufficient time—but no more time than necessary—for covered providers to meet the challenges of implementing 10-digit dialing in 87 area codes and of making necessary changes to their switches” therefore remains unchanged by the Suicide Hotline Act. Although the Suicide Hotline Act does not mention the Commission's earlier designation of 988 in the Report and Order, we construe Congress's independent designation of 988 in the Suicide Hotline Act as a ratification of the Commission's designation. Accordingly, the Report and Order is where to buy lasix online unaffected by the Suicide Hotline Act, except that we now clarify that the designation of 988 as the universal telephone number within the United States for the national suicide prevention and mental health crisis hotline will take effect on October 17, 2021, which is one year after the date of enactment of the Suicide Hotline Act, and not on October 16, 2020. This clarification is necessary to make the Report and Order consistent with Congress's clear intent that designation become effective one year after the date of enactment, as stated in section 3 of the Suicide Hotline Act.

To the extent necessary, we hereby waive the October 16, 2020 effective date of the designation in the Report and Order until one year after the date of where to buy lasix online enactment of the Suicide Hotline Act. This waiver is necessary to effectuate Congress's intent, and we are aware of no harm to the public interest that would be caused by adopting the effective date that Congress prescribed in the Suicide Hotline Act. The proceeding this Notice initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation where to buy lasix online or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies).

Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with rule 1.1206(b) where to buy lasix online. In proceedings governed by rule 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf).

Participants in this proceeding should where to buy lasix online familiarize themselves with the Commission's ex parte rules. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 where to buy lasix online FR 24121 (1998).

Electronic Filers. Comments may be filed where to buy lasix online electronically using the internet by accessing the ECFS. Http://apps.fcc.gov/​ecfs/​. Paper Filers.

Parties who choose to file by paper must file an original and one copy of where to buy lasix online each filing. Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail where to buy lasix online. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

Commercial overnight mail (other than U.S. Postal Service Express where to buy lasix online Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L where to buy lasix online Street NE, Washington, DC 20554.

Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of hypertension medications. See FCC Announces Closure of FCC Headquarters Open Window and Change in where to buy lasix online Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020). Https://www.fcc.gov/​document/​fcc-closes-headquarters-open-window-and-changes-hand-delivery-policy.

People with Disabilities. To request materials in accessible formats for people with disabilities (braille, large print, electronic where to buy lasix online files, audio format), send an email to fcc504@fcc.gov or call the Consumer &. Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY). Start Signature Federal Communications Commission where to buy lasix online.

Daniel Kahn, Associate Bureau Chief, Wireline Competition Bureau. End Signature End Supplemental Information [FR Doc. 2020-26917 Filed 12-7-20 where to buy lasix online. 8:45 am]BILLING CODE 6712-01-PNew research shows that deaths due to the mix of substance abuse and suicides known as “diseases of despair” declined slightly in 2018.

But the mortality rates throughout the Ohio Valley and Appalachian where to buy lasix online region are still higher than the national average. A report from the Appalachian Regional Commission found that overall mortality rates from diseases of despair, which include suicide, liver disease, and overdoses, decreased between 2017 and 2018 — the first decline since 2012. But the research, done by the Walsh Center for Rural Health Analysis and Center for Rural Health Research at East Tennessee State University, shows those mortality rates are still disproportionately higher for Appalachia compared to the rest of the United States. €œWhat’s interesting about this where to buy lasix online is how you define the decline,” Michael Meit explained.

Meit is the director of research and programs at the Center for Rural Health Research at ETSU and an author of the report. He said where to buy lasix online that the region’s diseases of despair mortality rate only decreased by one percentage point. €œIn 2015, diseases of despair as a group was 37% higher in the Appalachian region compared to the rest of the nation and now 2018 data shows it’s 36% higher.” By using the Centers for Disease Control and Prevention mortality rates, researchers are able to keep track of what’s happening in the region. 2018 is the most recent data on record.

What Meit found most interesting is the profile shift where to buy lasix online of the types of deaths within the region. €œWhere things changed is that the disparity in overdose went down considerably from 65 % higher to 48% higher,” Meit explained. €œBut that was then balanced out by suicide which went from 20% higher to 30% higher and alcohol liver disease which went from 8% higher to 13% higher.” He said the decline in diseases of despair mortality could be driven by a shift from opioid use to where to buy lasix online methamphetamines and the decline of overdose deaths.“It’s easy to overdose on opioids, particularly when fentanyl came around. That led to the spike in overdose mortality.

Methamphetamine does not typically lead to fatal overdose unless it is spiked with fentanyl or something else,” Meit said.As a whole, there are still major challenges in diseases of despair within the region.The diseases of despair mortality rate among 25 to 54-year-olds in Appalachia was 43% higher than the rest of the nation and disparities among women were larger in 2018 compared to the rest of the country.ARC Federal Co-Chairman Tim Thomas said in a press release that the Appalachian region still needs support. €œThis report highlights why where to buy lasix online ARC’s economic development efforts are so critical when it comes to addressing issues like substance abuse,” Thomas said.Researchers are anticipating the impacts of the hypertension lasix may have on disease of despair mortality rates in the future. The reports notes that “the impact of hypertension medications will likely lead to an increase in mortality from disease of despair, particularly as the Appalachian region and the rest of the United States experience economic challenges as a result of the lasix, isolation, and limitations on access to in-person treatment and recovery support.” Meit said anecdotal evidence suggests that there could be an increase in overdose deaths in 2020. That data won’t be available until late 2021 or 2022..

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