Health Policy

From the University of Nebraska, Lincoln (Mr. Puckett and Dr. Ryherd), University of Nebraska Medical Center, Omaha (Dr. Manley), and the University of Nebraska, Omaha (Dr. Ryan).

ABSTRACT

Objective: This study evaluated relationships between physical characteristics of nursing home residences and quality-of-care measures.

Design: This was a cross-sectional ecologic study. The dependent variables were 5 Centers for Medicare & Medicaid Services (CMS) Nursing Home Compare database long-stay quality measures (QMs) during 2019: percentage of residents who displayed depressive symptoms, percentage of residents who were physically restrained, percentage of residents who experienced 1 or more falls resulting in injury, percentage of residents who received antipsychotic medication, and percentage of residents who received anti-anxiety medication. The independent variables were 4 residence characteristics: ownership type, size, occupancy, and region within the United States. We explored how different types of each residence characteristic compare for each QM.

Setting, participants, and measurements: Quality measure values from 15,420 CMS-supported nursing homes across the United States averaged over the 4 quarters of 2019 reporting were used. Welch’s analysis of variance was performed to examine whether the mean QM values for groups within each residential characteristic were statistically different.

Results: Publicly owned and low-occupancy residences had the highest mean QM values, indicating the poorest performance. Nonprofit and high-occupancy residences generally had the lowest (ie, best) mean QM values. There were significant differences in mean QM values among nursing home sizes and regions.

Conclusion: This study suggests that residence characteristics are related to 5 nursing home QMs. Results suggest that physical characteristics may be related to overall quality of life in nursing homes.

Keywords: quality of care, quality measures, residence characteristics, Alzheimer’s disease and related dementias.

More than 55 million people worldwide are living with Alzheimer’s disease and related dementias (ADRD).¹ With the aging of the Baby Boomer population, this number is expected to rise to more than 78 million worldwide by 2030.¹ Given the growing number of cognitively impaired older adults, there is an increased need for residences designed for the specialized care of this population. Although there are dozens of living options for the elderly, and although most specialized establishments have the resources to meet the immediate needs of their residents, many facilities lack universal design features that support a high quality of life for someone with ADRD or mild cognitive impairment. Previous research has shown relationships between behavioral and psychological symptoms of dementia (BPSD) and environmental characteristics such as acoustics, lighting, and indoor air temperature.^2,3 Physical behaviors of BPSD, including aggression and wandering, and psychological symptoms, such as depression, anxiety, and delusions, put residents at risk of injury.⁴ Additionally, BPSD is correlated with caregiver burden and stress.^5-8 Patients with dementia may also experience a lower stress threshold, changes in perception of space, and decreased short-term memory, creating environmental difficulties for those with ADRD⁹ that lead them to exhibit BPSD due to poor environmental design. Thus, there is a need to learn more about design features that minimize BPSD and promote a high quality of life for those with ADRD.¹⁰

Although research has shown relationships between physical environmental characteristics and BPSD, in this work we study relationships between possible BPSD indicators and 4 residence-level characteristics: ownership type, size, occupancy, and region in the United States (determined by location of the Centers for Medicare & Medicaid Services [CMS] regional offices). We analyzed data from the CMS Nursing Home Compare database for the year 2019.¹¹ This database publishes quarterly data and star ratings for quality-of-care measures (QMs), staffing levels, and health inspections for every nursing home supported by CMS. Previous research has investigated the accuracy of QM reporting for resident falls, the impact of residential characteristics on administration of antipsychotic medication, the influence of profit status on resident outcomes and quality of care, and the effect of nursing home size on quality of life.^12-16 Additionally, research suggests that residential characteristics such as size and location could be associated with infection control in nursing homes.¹⁷

Certain QMs, such as psychotropic drug administration, resident falls, and physical restraint, provide indicators of agitation, disorientation, or aggression, which are often signals of BPSD episodes. We hypothesized that residence types are associated with different QM scores, which could indicate different occurrences of BPSD. We selected 5 QMs for long-stay residents that could potentially be used as indicators of BPSD. Short-stay resident data were not included in this work to control for BPSD that could be a result of sheer unfamiliarity with the environment and confusion from being in a new home.

Methods

Design and Data Collection

This was a cross-sectional ecologic study aimed at exploring relationships between aggregate residential characteristics and QMs. Data were retrieved from the 2019 annual archives found in the CMS provider data catalog on nursing homes, including rehabilitation services.¹¹ The dataset provides general residence information, such as ownership, number of beds, number of residents, and location, as well as residence quality metrics, such as QMs, staffing data, and inspection data. Residence characteristics and 4-quarter averages of QMs were retrieved and used as cross-sectional data. The data used are from 15,420 residences across the United States. Nursing homes located in Guam, the US Pacific Territories, Puerto Rico, and the US Virgin Islands, while supported by CMS and included in the dataset, were excluded from the study due to a severe absence of QM data.

Dependent Variables

We investigated 5 QMs that were averaged across the 4 quarters of 2019. The QMs used as dependent variables were percentage of residents who displayed depressive symptoms (depression), percentage of residents who were physically restrained (restraint), percentage of residents who experienced 1 or more falls resulting in a major injury (falls), percentage of residents who received antipsychotic medication (antipsychotic medication), and percentage of residents who received anti-anxiety or hypnotic medication (anti-anxiety medication).

A total of 2471 QM values were unreported across the 5 QM analyzed: 501 residences did not report depression data; 479 did not report restraint data; 477 did not report falls data; 508 did not report antipsychotic medication data; and 506 did not report anti-anxiety medication data. A residence with a missing QM value was excluded from that respective analysis.

To assess the relationships among the different QMs, a Pearson correlation coefficient r was computed for each unique pair of QMs (Figure). All QMs studied were found to be very weakly or weakly correlated with one another using the Evans classification for very weak and weak correlations (r < 0.20 and 0.20 < r < 0.39, respectively).¹⁸

Independent Variables

A total of 15,420 residences were included in the study. Seventy-nine residences did not report occupancy data, however, so those residences were excluded from the occupancy analyses. We categorized the ownership of each nursing home as for-profit, nonprofit, or public. We categorized nursing home size, based on quartiles of the size distribution, as large (> 127 beds), medium (64 to 126 beds), and small (< 64 beds). This method for categorizing the residential characteristics was similar to that used in previous work.¹⁹ Similarly, we categorized nursing home occupancy as high (> 92% occupancy), medium (73% to 91% occupancy), and low (< 73% occupancy) based on quartiles of the occupancy distribution. For the regional analysis, we grouped states together based on the CMS regional offices: Atlanta, Georgia; Boston, Massachusetts; Chicago, Illinois; Dallas, Texas; Denver, Colorado; Kansas City, Missouri; New York, New York; Philadelphia, Pennsylvania; San Francisco, California; and Seattle, Washington.²⁰

Analyses

We used Levene’s test to determine whether variances among the residential groups were equal for each QM, using an a priori α = 0.05. For all 20 tests conducted (4 residential characteristics for all 5 QMs), the resulting F-statistics were significant, indicating that the assumption of homogeneity of variance was not met.

We therefore used Welch’s analysis of variance (ANOVA) to evaluate whether the groups within each residential characteristic were the same on their QM means. For example, we tested whether for-profit, nonprofit, and public residences had significantly different mean depression rates. For statistically significant differences, a Games-Howell post-hoc test was conducted to test the difference between all unique pairwise comparisons. An a priori α = 0.05 was used for both Welch’s ANOVA and post-hoc testing. All analyses were conducted in RStudio Version 1.2.5033 (Posit Software, PBC).

Mean Differences

Mean QM scores for the 5 QMs investigated, grouped by residential characteristic for the 2019 year of reporting, are shown in Table 1. It should be noted that the number of residences that reported occupancy data (n = 15,341) does not equal the total number of residences included in the study (N = 15,420) because 79 residences did not report occupancy data. For all QMs reported in Table 1, lower scores are better. Table 2 and Table 3 show results from pairwise comparisons of mean differences for the different residential characteristic and QM groupings. Mean differences and 95% CI are presented along with an indication of statistical significance (when applicable).

Ownership

Nonprofit residences had significantly lower (ie, better) mean scores than for-profit and public residences for 3 QMs: resident depression, antipsychotic medication use, and anti-anxiety medication use. For-profit and public residences did not significantly differ in their mean values for these QMs. For-profit residences had a significantly lower mean score for resident falls than both nonprofit and public residences, but no significant difference existed between scores for nonprofit and public residence falls. There were no statistically significant differences between mean restraint scores among the ownership types.

Size

Large (ie, high-capacity) residences had a significantly higher mean depression score than both medium and small residences, but there was not a significant difference between medium and small residences. Large residences had the significantly lowest mean score for resident falls, and medium residences scored significantly lower than small residences. Medium residences had a significantly higher mean score for anti-anxiety medication use than both small and large residences, but there was no significant difference between small and large residences. There were no statistically significant differences between mean scores for restraint and antipsychotic medication use among the nursing home sizes.

Occupancy

The mean scores for 4 out of the 5 QMs exhibited similar relationships with occupancy rates: resident depression, falls, and antipsychotic and anti-anxiety medication use. Low-occupancy residences consistently scored significantly higher than both medium- and high-occupancy residences, and medium-occupancy residences consistently scored significantly higher than high-occupancy residences. On average, high-occupancy (≥ 92%) residences reported better QM scores than low-occupancy (< 73%) and medium-occupancy (73% to 91%) residences for all the QMs studied except physical restraint, which yielded no significant results. These findings indicate a possible inverse relationship between building occupancy rate and these 4 QMs.

Region

Pairwise comparisons of mean QM scores by region are shown in Table 3. The Chicago region had a significantly higher mean depression score than all other regions, while the San Francisco region’s score was significantly lower than all other regions, except Atlanta and Boston. The Kansas City region had a significantly higher mean score for resident falls than all other regions, with the exception of Denver, and the San Francisco region scored significantly lower than all other regions in falls. The Boston region had a significantly higher mean score for administering antipsychotic medication than all other regions, except for Kansas City and Seattle, and the New York and San Francisco regions both had significantly lower scores than all other regions except for each other. The Atlanta region reported a significantly higher mean score for administering antianxiety medication than all other regions, and the Seattle region’s score for anti-anxiety medication use was significantly lower than all other regions except for San Francisco.

This study presented mean percentages for 5 QMs reported in the Nursing Home Compare database for the year 2019: depression, restraint, falls, antipsychotic medication use, and anti-anxiety medication use. We investigated these scores by 4 residential characteristics: ownership type, size, occupancy, and region. In general, publicly owned and low-occupancy residences had the highest scores, and thus the poorest performances, for the 5 chosen QMs during 2019. Nonprofit and high-occupancy residences generally had the lowest (ie, better) scores, and this result agrees with previous findings on long-stay nursing home residents.²¹ One possible explanation for better performance by high-occupancy buildings could be that increased social interaction is beneficial to nursing home residents as compared with low-occupancy buildings, where less social interaction is probable. It is difficult to draw conclusions regarding nursing home size and region; however, there are significant differences among sizes for 3 out of the 5 QMs and significant differences among regions for all 5 QMs. The analyses suggest that residence-level characteristics are related to QM scores. Although reported QMs are not a direct representation of resident quality of life, this work agrees with previous research that residential characteristics have some impact on the lives of nursing home residents.^13-17 Improvements in QM reporting and changes in quality improvement goals since the formation of Nursing Home Compare exist, suggesting that nursing homes’ awareness of their reporting duties may impact quality of care or reporting tendencies.^21,22 Future research should consider investigating the impacts of the COVID-19 pandemic on quality-reporting trends and QM scores.

Other physical characteristics of nursing homes, such as noise, lighting levels, and air quality, may also have an impact on QMs and possibly nursing home residents themselves. This type of data exploration could be included in future research. Additionally, future research could include a similar analysis over a longer period, rather than the 1-year period examined here, to investigate which types of residences consistently have high or low scores or how different types of residences have evolved over the years, particularly considering the impact of the COVID-19 pandemic. Information such as staffing levels, building renovations, and inspection data could be accounted for in future studies. Different QMs could also be investigated to better understand the influence of residential characteristics on quality of care.

Conclusion

This study suggests that residence-level characteristics are related to 5 reported nursing home QMs. Overall, nonprofit and high-occupancy residences had the lowest QM scores, indicating the highest performance. Although the results do not necessarily suggest that residence-level characteristics impact individual nursing home residents’ quality of life, they suggest that physical characteristics affect overall quality of life in nursing homes. Future research is needed to determine the specific physical characteristics of these residences that affect QM scores.

Corresponding author: Brian J. Puckett, [email protected].

Disclosures: None reported.

From the University of Nebraska, Lincoln (Mr. Puckett and Dr. Ryherd), University of Nebraska Medical Center, Omaha (Dr. Manley), and the University of Nebraska, Omaha (Dr. Ryan).

ABSTRACT

Objective: This study evaluated relationships between physical characteristics of nursing home residences and quality-of-care measures.

Design: This was a cross-sectional ecologic study. The dependent variables were 5 Centers for Medicare & Medicaid Services (CMS) Nursing Home Compare database long-stay quality measures (QMs) during 2019: percentage of residents who displayed depressive symptoms, percentage of residents who were physically restrained, percentage of residents who experienced 1 or more falls resulting in injury, percentage of residents who received antipsychotic medication, and percentage of residents who received anti-anxiety medication. The independent variables were 4 residence characteristics: ownership type, size, occupancy, and region within the United States. We explored how different types of each residence characteristic compare for each QM.

Setting, participants, and measurements: Quality measure values from 15,420 CMS-supported nursing homes across the United States averaged over the 4 quarters of 2019 reporting were used. Welch’s analysis of variance was performed to examine whether the mean QM values for groups within each residential characteristic were statistically different.

Results: Publicly owned and low-occupancy residences had the highest mean QM values, indicating the poorest performance. Nonprofit and high-occupancy residences generally had the lowest (ie, best) mean QM values. There were significant differences in mean QM values among nursing home sizes and regions.

Conclusion: This study suggests that residence characteristics are related to 5 nursing home QMs. Results suggest that physical characteristics may be related to overall quality of life in nursing homes.

Keywords: quality of care, quality measures, residence characteristics, Alzheimer’s disease and related dementias.

More than 55 million people worldwide are living with Alzheimer’s disease and related dementias (ADRD).¹ With the aging of the Baby Boomer population, this number is expected to rise to more than 78 million worldwide by 2030.¹ Given the growing number of cognitively impaired older adults, there is an increased need for residences designed for the specialized care of this population. Although there are dozens of living options for the elderly, and although most specialized establishments have the resources to meet the immediate needs of their residents, many facilities lack universal design features that support a high quality of life for someone with ADRD or mild cognitive impairment. Previous research has shown relationships between behavioral and psychological symptoms of dementia (BPSD) and environmental characteristics such as acoustics, lighting, and indoor air temperature.^2,3 Physical behaviors of BPSD, including aggression and wandering, and psychological symptoms, such as depression, anxiety, and delusions, put residents at risk of injury.⁴ Additionally, BPSD is correlated with caregiver burden and stress.^5-8 Patients with dementia may also experience a lower stress threshold, changes in perception of space, and decreased short-term memory, creating environmental difficulties for those with ADRD⁹ that lead them to exhibit BPSD due to poor environmental design. Thus, there is a need to learn more about design features that minimize BPSD and promote a high quality of life for those with ADRD.¹⁰

Although research has shown relationships between physical environmental characteristics and BPSD, in this work we study relationships between possible BPSD indicators and 4 residence-level characteristics: ownership type, size, occupancy, and region in the United States (determined by location of the Centers for Medicare & Medicaid Services [CMS] regional offices). We analyzed data from the CMS Nursing Home Compare database for the year 2019.¹¹ This database publishes quarterly data and star ratings for quality-of-care measures (QMs), staffing levels, and health inspections for every nursing home supported by CMS. Previous research has investigated the accuracy of QM reporting for resident falls, the impact of residential characteristics on administration of antipsychotic medication, the influence of profit status on resident outcomes and quality of care, and the effect of nursing home size on quality of life.^12-16 Additionally, research suggests that residential characteristics such as size and location could be associated with infection control in nursing homes.¹⁷

Certain QMs, such as psychotropic drug administration, resident falls, and physical restraint, provide indicators of agitation, disorientation, or aggression, which are often signals of BPSD episodes. We hypothesized that residence types are associated with different QM scores, which could indicate different occurrences of BPSD. We selected 5 QMs for long-stay residents that could potentially be used as indicators of BPSD. Short-stay resident data were not included in this work to control for BPSD that could be a result of sheer unfamiliarity with the environment and confusion from being in a new home.

Methods

Design and Data Collection

This was a cross-sectional ecologic study aimed at exploring relationships between aggregate residential characteristics and QMs. Data were retrieved from the 2019 annual archives found in the CMS provider data catalog on nursing homes, including rehabilitation services.¹¹ The dataset provides general residence information, such as ownership, number of beds, number of residents, and location, as well as residence quality metrics, such as QMs, staffing data, and inspection data. Residence characteristics and 4-quarter averages of QMs were retrieved and used as cross-sectional data. The data used are from 15,420 residences across the United States. Nursing homes located in Guam, the US Pacific Territories, Puerto Rico, and the US Virgin Islands, while supported by CMS and included in the dataset, were excluded from the study due to a severe absence of QM data.

Dependent Variables

We investigated 5 QMs that were averaged across the 4 quarters of 2019. The QMs used as dependent variables were percentage of residents who displayed depressive symptoms (depression), percentage of residents who were physically restrained (restraint), percentage of residents who experienced 1 or more falls resulting in a major injury (falls), percentage of residents who received antipsychotic medication (antipsychotic medication), and percentage of residents who received anti-anxiety or hypnotic medication (anti-anxiety medication).

A total of 2471 QM values were unreported across the 5 QM analyzed: 501 residences did not report depression data; 479 did not report restraint data; 477 did not report falls data; 508 did not report antipsychotic medication data; and 506 did not report anti-anxiety medication data. A residence with a missing QM value was excluded from that respective analysis.

To assess the relationships among the different QMs, a Pearson correlation coefficient r was computed for each unique pair of QMs (Figure). All QMs studied were found to be very weakly or weakly correlated with one another using the Evans classification for very weak and weak correlations (r < 0.20 and 0.20 < r < 0.39, respectively).¹⁸

Independent Variables

A total of 15,420 residences were included in the study. Seventy-nine residences did not report occupancy data, however, so those residences were excluded from the occupancy analyses. We categorized the ownership of each nursing home as for-profit, nonprofit, or public. We categorized nursing home size, based on quartiles of the size distribution, as large (> 127 beds), medium (64 to 126 beds), and small (< 64 beds). This method for categorizing the residential characteristics was similar to that used in previous work.¹⁹ Similarly, we categorized nursing home occupancy as high (> 92% occupancy), medium (73% to 91% occupancy), and low (< 73% occupancy) based on quartiles of the occupancy distribution. For the regional analysis, we grouped states together based on the CMS regional offices: Atlanta, Georgia; Boston, Massachusetts; Chicago, Illinois; Dallas, Texas; Denver, Colorado; Kansas City, Missouri; New York, New York; Philadelphia, Pennsylvania; San Francisco, California; and Seattle, Washington.²⁰

Analyses

We used Levene’s test to determine whether variances among the residential groups were equal for each QM, using an a priori α = 0.05. For all 20 tests conducted (4 residential characteristics for all 5 QMs), the resulting F-statistics were significant, indicating that the assumption of homogeneity of variance was not met.

We therefore used Welch’s analysis of variance (ANOVA) to evaluate whether the groups within each residential characteristic were the same on their QM means. For example, we tested whether for-profit, nonprofit, and public residences had significantly different mean depression rates. For statistically significant differences, a Games-Howell post-hoc test was conducted to test the difference between all unique pairwise comparisons. An a priori α = 0.05 was used for both Welch’s ANOVA and post-hoc testing. All analyses were conducted in RStudio Version 1.2.5033 (Posit Software, PBC).

Mean Differences

Mean QM scores for the 5 QMs investigated, grouped by residential characteristic for the 2019 year of reporting, are shown in Table 1. It should be noted that the number of residences that reported occupancy data (n = 15,341) does not equal the total number of residences included in the study (N = 15,420) because 79 residences did not report occupancy data. For all QMs reported in Table 1, lower scores are better. Table 2 and Table 3 show results from pairwise comparisons of mean differences for the different residential characteristic and QM groupings. Mean differences and 95% CI are presented along with an indication of statistical significance (when applicable).

Ownership

Nonprofit residences had significantly lower (ie, better) mean scores than for-profit and public residences for 3 QMs: resident depression, antipsychotic medication use, and anti-anxiety medication use. For-profit and public residences did not significantly differ in their mean values for these QMs. For-profit residences had a significantly lower mean score for resident falls than both nonprofit and public residences, but no significant difference existed between scores for nonprofit and public residence falls. There were no statistically significant differences between mean restraint scores among the ownership types.

Size

Large (ie, high-capacity) residences had a significantly higher mean depression score than both medium and small residences, but there was not a significant difference between medium and small residences. Large residences had the significantly lowest mean score for resident falls, and medium residences scored significantly lower than small residences. Medium residences had a significantly higher mean score for anti-anxiety medication use than both small and large residences, but there was no significant difference between small and large residences. There were no statistically significant differences between mean scores for restraint and antipsychotic medication use among the nursing home sizes.

Occupancy

The mean scores for 4 out of the 5 QMs exhibited similar relationships with occupancy rates: resident depression, falls, and antipsychotic and anti-anxiety medication use. Low-occupancy residences consistently scored significantly higher than both medium- and high-occupancy residences, and medium-occupancy residences consistently scored significantly higher than high-occupancy residences. On average, high-occupancy (≥ 92%) residences reported better QM scores than low-occupancy (< 73%) and medium-occupancy (73% to 91%) residences for all the QMs studied except physical restraint, which yielded no significant results. These findings indicate a possible inverse relationship between building occupancy rate and these 4 QMs.

Region

Pairwise comparisons of mean QM scores by region are shown in Table 3. The Chicago region had a significantly higher mean depression score than all other regions, while the San Francisco region’s score was significantly lower than all other regions, except Atlanta and Boston. The Kansas City region had a significantly higher mean score for resident falls than all other regions, with the exception of Denver, and the San Francisco region scored significantly lower than all other regions in falls. The Boston region had a significantly higher mean score for administering antipsychotic medication than all other regions, except for Kansas City and Seattle, and the New York and San Francisco regions both had significantly lower scores than all other regions except for each other. The Atlanta region reported a significantly higher mean score for administering antianxiety medication than all other regions, and the Seattle region’s score for anti-anxiety medication use was significantly lower than all other regions except for San Francisco.

This study presented mean percentages for 5 QMs reported in the Nursing Home Compare database for the year 2019: depression, restraint, falls, antipsychotic medication use, and anti-anxiety medication use. We investigated these scores by 4 residential characteristics: ownership type, size, occupancy, and region. In general, publicly owned and low-occupancy residences had the highest scores, and thus the poorest performances, for the 5 chosen QMs during 2019. Nonprofit and high-occupancy residences generally had the lowest (ie, better) scores, and this result agrees with previous findings on long-stay nursing home residents.²¹ One possible explanation for better performance by high-occupancy buildings could be that increased social interaction is beneficial to nursing home residents as compared with low-occupancy buildings, where less social interaction is probable. It is difficult to draw conclusions regarding nursing home size and region; however, there are significant differences among sizes for 3 out of the 5 QMs and significant differences among regions for all 5 QMs. The analyses suggest that residence-level characteristics are related to QM scores. Although reported QMs are not a direct representation of resident quality of life, this work agrees with previous research that residential characteristics have some impact on the lives of nursing home residents.^13-17 Improvements in QM reporting and changes in quality improvement goals since the formation of Nursing Home Compare exist, suggesting that nursing homes’ awareness of their reporting duties may impact quality of care or reporting tendencies.^21,22 Future research should consider investigating the impacts of the COVID-19 pandemic on quality-reporting trends and QM scores.

Other physical characteristics of nursing homes, such as noise, lighting levels, and air quality, may also have an impact on QMs and possibly nursing home residents themselves. This type of data exploration could be included in future research. Additionally, future research could include a similar analysis over a longer period, rather than the 1-year period examined here, to investigate which types of residences consistently have high or low scores or how different types of residences have evolved over the years, particularly considering the impact of the COVID-19 pandemic. Information such as staffing levels, building renovations, and inspection data could be accounted for in future studies. Different QMs could also be investigated to better understand the influence of residential characteristics on quality of care.

Conclusion

This study suggests that residence-level characteristics are related to 5 reported nursing home QMs. Overall, nonprofit and high-occupancy residences had the lowest QM scores, indicating the highest performance. Although the results do not necessarily suggest that residence-level characteristics impact individual nursing home residents’ quality of life, they suggest that physical characteristics affect overall quality of life in nursing homes. Future research is needed to determine the specific physical characteristics of these residences that affect QM scores.

Corresponding author: Brian J. Puckett, [email protected].

Disclosures: None reported.

From the University of Nebraska, Lincoln (Mr. Puckett and Dr. Ryherd), University of Nebraska Medical Center, Omaha (Dr. Manley), and the University of Nebraska, Omaha (Dr. Ryan).

ABSTRACT

Objective: This study evaluated relationships between physical characteristics of nursing home residences and quality-of-care measures.

Design: This was a cross-sectional ecologic study. The dependent variables were 5 Centers for Medicare & Medicaid Services (CMS) Nursing Home Compare database long-stay quality measures (QMs) during 2019: percentage of residents who displayed depressive symptoms, percentage of residents who were physically restrained, percentage of residents who experienced 1 or more falls resulting in injury, percentage of residents who received antipsychotic medication, and percentage of residents who received anti-anxiety medication. The independent variables were 4 residence characteristics: ownership type, size, occupancy, and region within the United States. We explored how different types of each residence characteristic compare for each QM.

Setting, participants, and measurements: Quality measure values from 15,420 CMS-supported nursing homes across the United States averaged over the 4 quarters of 2019 reporting were used. Welch’s analysis of variance was performed to examine whether the mean QM values for groups within each residential characteristic were statistically different.

Results: Publicly owned and low-occupancy residences had the highest mean QM values, indicating the poorest performance. Nonprofit and high-occupancy residences generally had the lowest (ie, best) mean QM values. There were significant differences in mean QM values among nursing home sizes and regions.

Conclusion: This study suggests that residence characteristics are related to 5 nursing home QMs. Results suggest that physical characteristics may be related to overall quality of life in nursing homes.

Keywords: quality of care, quality measures, residence characteristics, Alzheimer’s disease and related dementias.

More than 55 million people worldwide are living with Alzheimer’s disease and related dementias (ADRD).¹ With the aging of the Baby Boomer population, this number is expected to rise to more than 78 million worldwide by 2030.¹ Given the growing number of cognitively impaired older adults, there is an increased need for residences designed for the specialized care of this population. Although there are dozens of living options for the elderly, and although most specialized establishments have the resources to meet the immediate needs of their residents, many facilities lack universal design features that support a high quality of life for someone with ADRD or mild cognitive impairment. Previous research has shown relationships between behavioral and psychological symptoms of dementia (BPSD) and environmental characteristics such as acoustics, lighting, and indoor air temperature.^2,3 Physical behaviors of BPSD, including aggression and wandering, and psychological symptoms, such as depression, anxiety, and delusions, put residents at risk of injury.⁴ Additionally, BPSD is correlated with caregiver burden and stress.^5-8 Patients with dementia may also experience a lower stress threshold, changes in perception of space, and decreased short-term memory, creating environmental difficulties for those with ADRD⁹ that lead them to exhibit BPSD due to poor environmental design. Thus, there is a need to learn more about design features that minimize BPSD and promote a high quality of life for those with ADRD.¹⁰

Although research has shown relationships between physical environmental characteristics and BPSD, in this work we study relationships between possible BPSD indicators and 4 residence-level characteristics: ownership type, size, occupancy, and region in the United States (determined by location of the Centers for Medicare & Medicaid Services [CMS] regional offices). We analyzed data from the CMS Nursing Home Compare database for the year 2019.¹¹ This database publishes quarterly data and star ratings for quality-of-care measures (QMs), staffing levels, and health inspections for every nursing home supported by CMS. Previous research has investigated the accuracy of QM reporting for resident falls, the impact of residential characteristics on administration of antipsychotic medication, the influence of profit status on resident outcomes and quality of care, and the effect of nursing home size on quality of life.^12-16 Additionally, research suggests that residential characteristics such as size and location could be associated with infection control in nursing homes.¹⁷

Certain QMs, such as psychotropic drug administration, resident falls, and physical restraint, provide indicators of agitation, disorientation, or aggression, which are often signals of BPSD episodes. We hypothesized that residence types are associated with different QM scores, which could indicate different occurrences of BPSD. We selected 5 QMs for long-stay residents that could potentially be used as indicators of BPSD. Short-stay resident data were not included in this work to control for BPSD that could be a result of sheer unfamiliarity with the environment and confusion from being in a new home.

Methods

Design and Data Collection

This was a cross-sectional ecologic study aimed at exploring relationships between aggregate residential characteristics and QMs. Data were retrieved from the 2019 annual archives found in the CMS provider data catalog on nursing homes, including rehabilitation services.¹¹ The dataset provides general residence information, such as ownership, number of beds, number of residents, and location, as well as residence quality metrics, such as QMs, staffing data, and inspection data. Residence characteristics and 4-quarter averages of QMs were retrieved and used as cross-sectional data. The data used are from 15,420 residences across the United States. Nursing homes located in Guam, the US Pacific Territories, Puerto Rico, and the US Virgin Islands, while supported by CMS and included in the dataset, were excluded from the study due to a severe absence of QM data.

Dependent Variables

We investigated 5 QMs that were averaged across the 4 quarters of 2019. The QMs used as dependent variables were percentage of residents who displayed depressive symptoms (depression), percentage of residents who were physically restrained (restraint), percentage of residents who experienced 1 or more falls resulting in a major injury (falls), percentage of residents who received antipsychotic medication (antipsychotic medication), and percentage of residents who received anti-anxiety or hypnotic medication (anti-anxiety medication).

A total of 2471 QM values were unreported across the 5 QM analyzed: 501 residences did not report depression data; 479 did not report restraint data; 477 did not report falls data; 508 did not report antipsychotic medication data; and 506 did not report anti-anxiety medication data. A residence with a missing QM value was excluded from that respective analysis.

To assess the relationships among the different QMs, a Pearson correlation coefficient r was computed for each unique pair of QMs (Figure). All QMs studied were found to be very weakly or weakly correlated with one another using the Evans classification for very weak and weak correlations (r < 0.20 and 0.20 < r < 0.39, respectively).¹⁸

Independent Variables

A total of 15,420 residences were included in the study. Seventy-nine residences did not report occupancy data, however, so those residences were excluded from the occupancy analyses. We categorized the ownership of each nursing home as for-profit, nonprofit, or public. We categorized nursing home size, based on quartiles of the size distribution, as large (> 127 beds), medium (64 to 126 beds), and small (< 64 beds). This method for categorizing the residential characteristics was similar to that used in previous work.¹⁹ Similarly, we categorized nursing home occupancy as high (> 92% occupancy), medium (73% to 91% occupancy), and low (< 73% occupancy) based on quartiles of the occupancy distribution. For the regional analysis, we grouped states together based on the CMS regional offices: Atlanta, Georgia; Boston, Massachusetts; Chicago, Illinois; Dallas, Texas; Denver, Colorado; Kansas City, Missouri; New York, New York; Philadelphia, Pennsylvania; San Francisco, California; and Seattle, Washington.²⁰

Analyses

We used Levene’s test to determine whether variances among the residential groups were equal for each QM, using an a priori α = 0.05. For all 20 tests conducted (4 residential characteristics for all 5 QMs), the resulting F-statistics were significant, indicating that the assumption of homogeneity of variance was not met.

We therefore used Welch’s analysis of variance (ANOVA) to evaluate whether the groups within each residential characteristic were the same on their QM means. For example, we tested whether for-profit, nonprofit, and public residences had significantly different mean depression rates. For statistically significant differences, a Games-Howell post-hoc test was conducted to test the difference between all unique pairwise comparisons. An a priori α = 0.05 was used for both Welch’s ANOVA and post-hoc testing. All analyses were conducted in RStudio Version 1.2.5033 (Posit Software, PBC).

Mean Differences

Mean QM scores for the 5 QMs investigated, grouped by residential characteristic for the 2019 year of reporting, are shown in Table 1. It should be noted that the number of residences that reported occupancy data (n = 15,341) does not equal the total number of residences included in the study (N = 15,420) because 79 residences did not report occupancy data. For all QMs reported in Table 1, lower scores are better. Table 2 and Table 3 show results from pairwise comparisons of mean differences for the different residential characteristic and QM groupings. Mean differences and 95% CI are presented along with an indication of statistical significance (when applicable).

Ownership

Nonprofit residences had significantly lower (ie, better) mean scores than for-profit and public residences for 3 QMs: resident depression, antipsychotic medication use, and anti-anxiety medication use. For-profit and public residences did not significantly differ in their mean values for these QMs. For-profit residences had a significantly lower mean score for resident falls than both nonprofit and public residences, but no significant difference existed between scores for nonprofit and public residence falls. There were no statistically significant differences between mean restraint scores among the ownership types.

Size

Large (ie, high-capacity) residences had a significantly higher mean depression score than both medium and small residences, but there was not a significant difference between medium and small residences. Large residences had the significantly lowest mean score for resident falls, and medium residences scored significantly lower than small residences. Medium residences had a significantly higher mean score for anti-anxiety medication use than both small and large residences, but there was no significant difference between small and large residences. There were no statistically significant differences between mean scores for restraint and antipsychotic medication use among the nursing home sizes.

Occupancy

The mean scores for 4 out of the 5 QMs exhibited similar relationships with occupancy rates: resident depression, falls, and antipsychotic and anti-anxiety medication use. Low-occupancy residences consistently scored significantly higher than both medium- and high-occupancy residences, and medium-occupancy residences consistently scored significantly higher than high-occupancy residences. On average, high-occupancy (≥ 92%) residences reported better QM scores than low-occupancy (< 73%) and medium-occupancy (73% to 91%) residences for all the QMs studied except physical restraint, which yielded no significant results. These findings indicate a possible inverse relationship between building occupancy rate and these 4 QMs.

Region

Pairwise comparisons of mean QM scores by region are shown in Table 3. The Chicago region had a significantly higher mean depression score than all other regions, while the San Francisco region’s score was significantly lower than all other regions, except Atlanta and Boston. The Kansas City region had a significantly higher mean score for resident falls than all other regions, with the exception of Denver, and the San Francisco region scored significantly lower than all other regions in falls. The Boston region had a significantly higher mean score for administering antipsychotic medication than all other regions, except for Kansas City and Seattle, and the New York and San Francisco regions both had significantly lower scores than all other regions except for each other. The Atlanta region reported a significantly higher mean score for administering antianxiety medication than all other regions, and the Seattle region’s score for anti-anxiety medication use was significantly lower than all other regions except for San Francisco.

This study presented mean percentages for 5 QMs reported in the Nursing Home Compare database for the year 2019: depression, restraint, falls, antipsychotic medication use, and anti-anxiety medication use. We investigated these scores by 4 residential characteristics: ownership type, size, occupancy, and region. In general, publicly owned and low-occupancy residences had the highest scores, and thus the poorest performances, for the 5 chosen QMs during 2019. Nonprofit and high-occupancy residences generally had the lowest (ie, better) scores, and this result agrees with previous findings on long-stay nursing home residents.²¹ One possible explanation for better performance by high-occupancy buildings could be that increased social interaction is beneficial to nursing home residents as compared with low-occupancy buildings, where less social interaction is probable. It is difficult to draw conclusions regarding nursing home size and region; however, there are significant differences among sizes for 3 out of the 5 QMs and significant differences among regions for all 5 QMs. The analyses suggest that residence-level characteristics are related to QM scores. Although reported QMs are not a direct representation of resident quality of life, this work agrees with previous research that residential characteristics have some impact on the lives of nursing home residents.^13-17 Improvements in QM reporting and changes in quality improvement goals since the formation of Nursing Home Compare exist, suggesting that nursing homes’ awareness of their reporting duties may impact quality of care or reporting tendencies.^21,22 Future research should consider investigating the impacts of the COVID-19 pandemic on quality-reporting trends and QM scores.

Other physical characteristics of nursing homes, such as noise, lighting levels, and air quality, may also have an impact on QMs and possibly nursing home residents themselves. This type of data exploration could be included in future research. Additionally, future research could include a similar analysis over a longer period, rather than the 1-year period examined here, to investigate which types of residences consistently have high or low scores or how different types of residences have evolved over the years, particularly considering the impact of the COVID-19 pandemic. Information such as staffing levels, building renovations, and inspection data could be accounted for in future studies. Different QMs could also be investigated to better understand the influence of residential characteristics on quality of care.

Conclusion

This study suggests that residence-level characteristics are related to 5 reported nursing home QMs. Overall, nonprofit and high-occupancy residences had the lowest QM scores, indicating the highest performance. Although the results do not necessarily suggest that residence-level characteristics impact individual nursing home residents’ quality of life, they suggest that physical characteristics affect overall quality of life in nursing homes. Future research is needed to determine the specific physical characteristics of these residences that affect QM scores.

Corresponding author: Brian J. Puckett, [email protected].

Disclosures: None reported.

From the U.S. Department of Veterans Affairs (all authors), and Cognosante, LLC, Falls Church, VA (Dr. Murray, Dr. Sawyer, and Jessica Fankhauser).

Abstract

Objective: The COVID-19 pandemic posed unprecedented leadership challenges to health care organizations worldwide, especially those on the journey to high reliability. The objective of this pilot quality improvement initiative was to describe the experiences of medical center leaders continuing along the journey to high reliability during the pandemic.

Methods: A convenience sample of Veterans Health Administration medical center directors at facilities that had initiated the journey to high reliability prior to or during the COVID-19 pandemic were asked to complete a confidential survey to explore the challenges experienced and lessons learned.

Results: Of the 35 potential participants, 15 completed the confidential web-based survey. Five major themes emerged from participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum.

Conclusion: This pilot quality improvement initiative provides some insight into the challenges experienced and lessons learned during the COVID-19 pandemic to help inform health care leaders’ responses during crises they may encounter along the journey to becoming a high reliability organization.

Keywords: HRO, leadership, patient safety.

Health care leaders worldwide agree that the COVID-19 pandemic has presented one of the most challenging leadership tests encountered in many generations,^1,2 creating a widespread crisis of unprecedented scope and scale for health care systems globally.^2,3 COVID-19 has posed many challenges and obstacles for health care leaders, including overworked, overstressed, and socially isolated employees; expedited hiring to ensure adequate staffing; reallocation of employees to other units; supply shortages such as personal protective equipment; changing polices related to safety protocols; modifying operations; reorganizing facilities to care for large volumes of critically ill patients; and ethical challenges.^4-8 Health care systems were required to create and implement new clinical, operational, and staffing protocols that extended capabilities far beyond conventional standards of care and crisis response operations.⁹ To provide a picture of the impact of COVID-19 on the Veterans Health Administration (VHA), as of March 3, 2023, the VHA has fully vaccinated more than 4.7 million individuals, including 4.3 million veterans and 320,936 federal employees.^10,11

Maintaining continuous progress toward advancing high reliability organization (HRO) principles and practices can be especially challenging during crises of unprecedented scale such as the pandemic. HROs must be continually focused on achieving safety, quality, and efficiency goals by attending to the 3 pillars of HRO: culture, leadership, and continuous process improvement. HROs promote a culture where all staff across the organization watch for and report any unsafe conditions before these conditions pose a greater risk in the workplace. Hospital leaders, from executives to frontline managers, must be cognizant of all systems and processes that have the potential to affect patient care.¹² All of the principles of HROs must continue without fail to ensure patient safety; these principles include preoccupation with failure, anticipating unexpected risks, sensitivity to dynamic and ever-changing operations, avoiding oversimplifications of identified problems, fostering resilience across the organization, and deferring to those with the expertise to make the best decisions regardless of position, rank, or title.^12,13 Given the demands faced by leaders during crises with unprecedented disruption to normal operating procedures, it can be especially difficult to identify systemic challenges and apply lessons learned in a timely manner. However, it is critical to identify such lessons in order to continuously improve and to increase preparedness for subsequent crises.^13,14

Because of the COVID-19 pandemic’s unprecedented nature in recent history, a review of the literature produced little evidence exploring the challenges experienced and lessons learned by health care leaders, especially as it relates to implementing or sustaining HRO journeys during the COVID-19 pandemic. Related literature published to date consists of editorials on reliability, uncertainty, and the management of errors¹⁵; patient safety and high reliability preventive strategies¹⁶; and authentic leadership.¹⁷ Five viewpoints were published on HROs and maladaptive stress behaviors,¹⁸ mindful organizing and organizational reliability,¹⁹ the practical essence of HROs,²⁰ embracing principles of HROs in crisis,⁸ and using observation and high reliability strategies when facing an unprecedented safety threat.²¹ Finally, the authors identified 2 studies that used a qualitative research approach to explore leadership functions within an HRO when managing crises²² and organizational change in response to the COVID-19 pandemic.²³ Due to the paucity of available information, the authors undertook a pilot quality improvement (QI) initiative to address this knowledge gap.

The aim of this initiative was to gain a better understanding of the challenges experienced, lessons learned, and recommendations to be shared by VHA medical center directors (MCDs) of health care facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The authors hope that this information will help health care leaders across both governmental and nongovernmental organizations, nationally and globally, to prepare for future pandemics, other unanticipated crises (eg, natural disasters, terrorist attacks), and major change initiatives (eg, electronic health record modernization) that may affect the delivery of safe, high-quality, and effective patient care. The initiative is described using the SQUIRE 2.0 guidelines.^24,25

Methods

Survey

We used a qualitative approach and administered a confidential web-based survey, developed by the project team, to VHA MCDs at facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The survey consisted of 8 participant characteristic questions (Table 1) and 4 open-ended questions. The open-ended questions were designed to encourage MCD participants to freely provide detailed descriptions of the challenges experienced, lessons learned, recommendations for other health care leaders, and any additional information they believed was relevant.^26,27 Participants were asked to respond to the following items:

1. Please describe any challenges you experienced while in the role of MCD at a facility that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic.

1. What are some lessons that you learned when responding to the COVID-19 pandemic while on the journey to high reliability?
2. What recommendations would you like to make to other health care leaders to enable them to respond effectively to crises while on the journey to high reliability?
3. Please provide any additional information that would be of value.

An invitation to participate in this pilot QI initiative was sent via e-mail to 35 potential participants, who were all MCDs at Cohort 1 and Cohort 2 facilities. The invitation was sent on June 17, 2022, by a VHA senior High Reliability Enterprise Support government team member not directly involved with the initiative. The participants were given 3 weeks to complete the survey. A reminder was sent at the end of week 1 and the beginning of week 3. The VHA MCDs from Cohort 1 (n = 17) began the HRO journey in February 2019 and those in Cohort 2 (n = 18) initiated the HRO journey in October 2020. Because the VHA is the largest integrated health care system in the United States, the potential participants were geographically dispersed. Examples of locations in Cohort 1 include Manchester Veterans Affairs Medical Center (VAMC) in New Hampshire, Ralph H. Johnson VAMC in Charleston, South Carolina, and Boise VAMC, in Idaho. Examples of Cohort 2 locations include Chillicothe VAMC in Ohio, Marion VAMC in Indiana, and John D. Dingell VAMC in Detroit, Michigan.

The invitation included the objective of the initiative, estimated time to complete the confidential web-based survey, time allotted for responses to be submitted, and a link to the survey should potential participants agree to participate. Potential participants were informed that their involvement was voluntary, based on their willingness to participate and available time to complete the survey. Finally, the invitation noted that any comments provided would remain confidential and nonattributional for the purpose of publishing and presenting. The inclusion criteria for participation were: (1) serving in the role of MCD of an organization that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic; (2) voluntary participation; and (3) thorough responses provided to the 4 open-ended and 8 participant characteristic questions, according to the instructions provided.

Data Gathering and Analysis

To minimize bias and maintain neutrality at the organizational level, only non-VHA individuals working on the project were directly involved with participants’ data review and analysis. Participant characteristics were analyzed using descriptive statistics. Responses to the 4 open-ended questions were coded and analyzed by an experienced researcher and coauthor using NVivo 11 qualitative data analysis software.²⁸ To ensure trustworthiness (credibility, transferability, dependability, and confirmability) in the data analysis procedure,²⁹ inductive thematic analysis was also performed manually using the methodologies of Braun and Clarke (Table 2)³⁰ and Erlingsson and Brysiewicz.³¹ The goal of inductive analysis is to allow themes to emerge from the data while minimizing preconceptions.^32,33 Regular team meetings were held to discuss and review the progress of data collection and analysis. The authors agreed that the themes were representative of the participants’ responses.

Institutional review board (IRB) review and approval were not required, as this project was a pilot QI initiative. The intent of the initiative was to explore ways to improve the quality of care delivered in the participants’ local care settings and not to generalize the findings. Under these circumstances, formal IRB review and approval of a QI initiative are not required.³⁴ Participation in this pilot QI initiative was voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent. Confidentiality was ensured at all times by avoiding both the use of facility names and the collection of participant identifiers. Unique numbers were assigned to each participant. All comments provided by survey participants remained confidential and nonattributional for the purpose of publishing and presenting.

Results

Of the 35 potential participants, 15 VHA MCDs (43%) completed the confidential web-based survey. Out of the 17 potential participants in Cohort 1, 6 (35%) completed the survey. With Cohort 2, 9 (50%) of the potential 18 participants responded. Although saturation was reached at 10 responses, the additional completed surveys were included in the analysis. Saturation can be achieved with a small number of participants (n = 9–17), particularly when the potential participants are relatively homogenous and project aims are narrowly defined.³⁵ Most participants had more than 10 years of executive-level experience and most medical centers had been on the journey to high reliability for more than 12 months at the time of the pandemic (Table 3). Five major themes emerged from the participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum. In the following sections, the numbers in parentheses after the direct quotes represent the unique numbers assigned to the participant providing the response.

Managing Competing Priorities

When analyzing the responses to question 1, a recurring theme from 7 participants (Cohort 1, n = 4; Cohort 2, n = 3) related to challenges encountered while continuing the journey to high reliability during COVID-19 was managing competing priorities. Although most participants reported extensive previous leadership experience, some did not feel prepared for the complexity, uncertainty, challenges, and multitude of competing priorities facing the journey to high reliability during the COVID-19 pandemic. One participant succinctly noted:

“There were too many competing priorities dealing with the pandemic and staffing crisis.” (Participant 8)

Other participants shared:

“We had our HRO mentor designated just as our first peak was descending on us. It was initially challenging to determine the proper pace of implementation when we clearly had other things going on. There was a real risk that people would say, ‘What, are you kidding?’ as we tried to roll this out.” (Participant 4)

“Prior to COVID, our main challenges were getting organized and operational rollout. During the pandemic, we had to shift our focus to COVID and the training aspects suffered. Also, many other priorities pulled us away from an HRO rollout focus.” (Participant 6)

Staying Committed

When examining the question 2 responses, 1 theme that resonated most when it came to lessons learned, shared by 6 participants (Cohort 1, n = 4; Cohort 2, n = 2), was the need to stay committed to HRO, despite the unprecedented crisis at hand. A number of participants eloquently noted how important it was stay committed to the HRO journey during the COVID-19 pandemic:

“If you don’t need a highly reliable organization during a crisis, when do you need it? That was the message that we kicked off with. It was also VERY important to take things slowly. Education had to be done in bits, and we had a much more modest timeline than what would have been the norm for any initiative pre-COVID. The emphasis was on this being a long-term commitment, that we would be doing it the right way rather than rushing it, etc.” (Participant 4)

“Keeping HRO principles and a Just Culture on the forefront of our minds, we looked for opportunities to progress on our HRO journey, despite the challenges of the pandemic. Our monthly Town Halls became weekly events to share COVID updates and information with staff. We used the Town Halls to promote our HRO mission and to open communication lines with staff, designating 1 week each month as a ‘Safety Forum.’ The pandemic provided the springboard and backdrop for staff Safety Stories submissions, many of which were shared at our Town Halls and Safety Forums.” (Participant 7)

“We were able to utilize HRO principles in response to the COVID pandemic. Specifically standardized communication from the facility to VISN [Veterans Integrated Services Network] was initiated on a daily basis. This practice provided daily communication on key operational items and clinical items at the medical center, allowed timely feedback on actions being taken, as was instrumental in daily checks on staffing, COVID testing supplies, overall supply chain issues.” (Participant 9)

Adapting and Overcoming

The recommendations provided by 10 participants (Cohort 1, n = 6; Cohort 2, n = 4) for other health care leaders experiencing a crisis during the journey to high reliability were insightful. The themes that frequently emerged from the responses to the survey were to adapt and overcome. Participants shared:

“Utilize the many tools you’re given, specifically your team. Try even the craziest ideas from frontline staff.” (Participant 1)

“Use your mentors for younger directors and, even if you think you know the answer, involve your staff. It makes them feel they have a voice and gives them ownership of the issues.” (Participant 5)

“Make sure that you have key leaders in place who are committed to HRO and can help the organization adjust.” (Participant 6)

“Take advantage of HRO Leader Coaching, which pairs MCDs with coaches who act as consultants for HRO leadership practices to ensure progress in reaching the next level in the journey to High Reliability.” (Participant 7)

“Meet regularly with the HRO Lead and team (more frequently during early stages of implementation) to provide support, eliminate barriers, and champion the HRO mission. It is important to include other members of the ELT [Executive Leadership Team] to ensure their involvement with the facility HRO strategic plan.” (Participant 7)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

Prioritizing Competing Demands

The theme of prioritizing competing demands emerged again from 5 participants (Cohort 1, n = 3; Cohort 2, n = 2) with question 3 describing recommendations for other leaders:

“Your first priority is to the crisis. Don’t get distracted by this or any other initiative. That was not a very popular message for the people pushing HRO, but it is the reality and the necessity. However, it IS possible to move forward with HRO (or other important initiatives) during crisis times, as long as you carefully consider what you are asking of people and don’t overload/overwhelm them. It is not your ego (or that of Central Office) that needs to be stoked. If the initiative truly has value, you need to be patient to see it done properly, rather than rushed/pushed/forced. Don’t kill it by being overeager and overwhelming your already overtaxed people. That said, keep moving forward. The key is pacing—and remember that your Type A hard-driving leader types (you know who you are) will certainly fail if they push it. Or even if they go at a normal pace that would be appropriate for noncrisis times.” (Participant 4)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

“It was critical for us to always focus on the immediate workplace safety of staff (especially those on the frontlines of the pandemic response) when in the process of rolling out HRO initiatives.” (Participant 14)

Maintaining Momentum

When analyzing additional information that participants thought would be of value, 3 participants (Cohort 1, n=2; Cohort 2, n=1) noted the importance of maintaining momentum with HRO during a crisis:

“It seemed as though communication and education from VHA on HRO slowed down at the same time, which further slowed our progress. We are now trying to ramp our engagement up again.” (Participant 3)

“There can be synergy between crisis response and HRO implementation. As an example, one of the first steps we took was leadership rounding. That was necessary anyways for crisis management (raising the spirits on the front lines, so to speak). What we did was include scheduled time instead of (in addition to) ad hoc. And we got credit for taking an HRO step. I resisted whiteboards/visual management systems for a long time because (in my opinion) that would have been much too distracting during the crisis. Having waited for better times, I was able to move forward with that several months later and with good success.” (Participant 4)

Discussion

Health care leaders worldwide experienced an immense set of challenges because of the COVID-19 pandemic, which is a crisis of a magnitude with no parallel in modern times. Strong, adaptive leadership at all levels of health care systems was needed to effectively address the immense crisis at hand.^36,37 Findings from this pilot QI initiative suggest that MCDs faced many new challenges, requiring them to perform unfamiliar tasks and manage numerous overlapping challenges (eg, staffing shortages and reassignments, safety concerns, changes to patient appointments, backlogs in essential services), all while also trying to continue with the journey to high reliability. Despite the challenges leaders faced, they recognized the need to manage competing priorities early and effectively. At times, the priority was to address the wide-ranging, urgent issues related to the pandemic. When the conditions improved, there was time to refocus efforts on important but longer-term activities related to the HRO journey. Other participants recognized that their commitment to HRO needed to remain a priority even during the periods of intense focus on COVID-19. These participants continuously looked for ways to integrate HRO principles and practices into their response to the extraordinary challenges of the pandemic. Emerging research highlights how leaders had to modify their day-to-day responsibilities because of the wide disruptions caused by the COVID-19 pandemic, even when not on the journey to becoming an HRO.^36,37

Some participants felt compelled to stay committed to the HRO journey despite numerous competing demands. They stayed committed to looking for opportunities to progress by implementing HRO principles and practices to achieve safety, quality, and efficiency goals. This dedication is noteworthy, especially in light of recently published research that demonstrates the vast number of patient safety issues that presented during the COVID-19 pandemic (eg, ineffective communication, poor teamwork, the absence of coordination)¹ as well as perceptions that patient safety and quality of care had significantly declined as a result of the crisis.^36,37

Participants also highlighted the need to be adaptive when responding to the complexity and unpredictability of the pandemic. Participants regularly sought ways to increase their knowledge, skills, and abilities by using the resources (eg, tools, experts) available to them. Research shows that in increasingly complex and ever-changing situation such as the COVID-19 pandemic, leaders must be adaptive with all levels of performance, especially when limited information is available.^38,39

This is the first initiative of its kind to specifically explore the challenges experienced and lessons learned from health care leaders continuing along the journey to high reliability during the COVID-19 pandemic. Findings from this pilot QI initiative revealed that many participants recommended that leaders adapt and overcome challenges as much as possible when continuing with HRO during a crisis. These findings are echoed in the current literature suggesting that adaptive performance is a highly effective form of leadership during crises.^38,40 Being able to effectively adapt during a crisis is essential for reducing further vulnerabilities across health care systems. In fact, this lesson is shared by many countries in response to the unprecedented global crisis.⁴¹A limitation of this pilot QI initiative is that the authors did not directly solicit responses from all VHA MCDs or from other health care executives (eg, Chief of Staff, Associate Director for Operations, Associate Director for Patient Care, and Nurse Executive). As such, our findings represent only a small segment of senior leadership perspectives from a large, integrated health care system. Individuals who did not respond to the survey may have had different experiences than those who did, and the authors excluded many MCDs who formally began their HRO journeys in 2022, well after the pandemic was underway. Similarly, the experiences of Veterans Affairs leaders may or may not be similar to that of other health care organizations. Although the goal of this initiative was to explore the participants’ experiences during the period of crisis, time and distance from the events at the height of the COVID-19 pandemic may have resulted in difficulty recalling information as well as making sense of the occurrence. This potential recall bias is a common occurrence in trying to explore past experiences, especially as they relate to crises. Finally, this pilot QI initiative did not explore personal challenges participants may have faced during this period of time (eg, burnout, personal or family illness), which may have also shaped their responses.

Conclusion

This initiative suggests that VHA MCDs often relied on HRO principles to guide and assist with their response to the COVID-19 pandemic, including managing periods of unprecedented crisis. The ability to adapt and prioritize was seen as an especially important lesson. Many MCDs continued their personal and organizational efforts toward high reliability even in periods of intense challenge because of the pandemic. These findings can help with future crises that may occur during an organization’s journey to high reliability. This pilot QI initiative’s findings warrant further investigation to explore the experiences of the broader range of health care leaders while responding to unplanned crises or even planned large-scale cultural change or technology modernization initiatives (eg, electronic health record modernization) to expand the state of the science of high reliability as well as inform policy and decision-making. Finally, another area for future study is examining how leadership responses vary across facilities, depending on factors such as leader roles, facility complexity level, resource availability, patient population characteristics, and organizational culture.

Acknowledgment: The authors express their sincere gratitude to the medical center directors who participated in this pilot study.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel St., Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

From the U.S. Department of Veterans Affairs (all authors), and Cognosante, LLC, Falls Church, VA (Dr. Murray, Dr. Sawyer, and Jessica Fankhauser).

Abstract

Objective: The COVID-19 pandemic posed unprecedented leadership challenges to health care organizations worldwide, especially those on the journey to high reliability. The objective of this pilot quality improvement initiative was to describe the experiences of medical center leaders continuing along the journey to high reliability during the pandemic.

Methods: A convenience sample of Veterans Health Administration medical center directors at facilities that had initiated the journey to high reliability prior to or during the COVID-19 pandemic were asked to complete a confidential survey to explore the challenges experienced and lessons learned.

Results: Of the 35 potential participants, 15 completed the confidential web-based survey. Five major themes emerged from participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum.

Conclusion: This pilot quality improvement initiative provides some insight into the challenges experienced and lessons learned during the COVID-19 pandemic to help inform health care leaders’ responses during crises they may encounter along the journey to becoming a high reliability organization.

Keywords: HRO, leadership, patient safety.

Health care leaders worldwide agree that the COVID-19 pandemic has presented one of the most challenging leadership tests encountered in many generations,^1,2 creating a widespread crisis of unprecedented scope and scale for health care systems globally.^2,3 COVID-19 has posed many challenges and obstacles for health care leaders, including overworked, overstressed, and socially isolated employees; expedited hiring to ensure adequate staffing; reallocation of employees to other units; supply shortages such as personal protective equipment; changing polices related to safety protocols; modifying operations; reorganizing facilities to care for large volumes of critically ill patients; and ethical challenges.^4-8 Health care systems were required to create and implement new clinical, operational, and staffing protocols that extended capabilities far beyond conventional standards of care and crisis response operations.⁹ To provide a picture of the impact of COVID-19 on the Veterans Health Administration (VHA), as of March 3, 2023, the VHA has fully vaccinated more than 4.7 million individuals, including 4.3 million veterans and 320,936 federal employees.^10,11

Maintaining continuous progress toward advancing high reliability organization (HRO) principles and practices can be especially challenging during crises of unprecedented scale such as the pandemic. HROs must be continually focused on achieving safety, quality, and efficiency goals by attending to the 3 pillars of HRO: culture, leadership, and continuous process improvement. HROs promote a culture where all staff across the organization watch for and report any unsafe conditions before these conditions pose a greater risk in the workplace. Hospital leaders, from executives to frontline managers, must be cognizant of all systems and processes that have the potential to affect patient care.¹² All of the principles of HROs must continue without fail to ensure patient safety; these principles include preoccupation with failure, anticipating unexpected risks, sensitivity to dynamic and ever-changing operations, avoiding oversimplifications of identified problems, fostering resilience across the organization, and deferring to those with the expertise to make the best decisions regardless of position, rank, or title.^12,13 Given the demands faced by leaders during crises with unprecedented disruption to normal operating procedures, it can be especially difficult to identify systemic challenges and apply lessons learned in a timely manner. However, it is critical to identify such lessons in order to continuously improve and to increase preparedness for subsequent crises.^13,14

Because of the COVID-19 pandemic’s unprecedented nature in recent history, a review of the literature produced little evidence exploring the challenges experienced and lessons learned by health care leaders, especially as it relates to implementing or sustaining HRO journeys during the COVID-19 pandemic. Related literature published to date consists of editorials on reliability, uncertainty, and the management of errors¹⁵; patient safety and high reliability preventive strategies¹⁶; and authentic leadership.¹⁷ Five viewpoints were published on HROs and maladaptive stress behaviors,¹⁸ mindful organizing and organizational reliability,¹⁹ the practical essence of HROs,²⁰ embracing principles of HROs in crisis,⁸ and using observation and high reliability strategies when facing an unprecedented safety threat.²¹ Finally, the authors identified 2 studies that used a qualitative research approach to explore leadership functions within an HRO when managing crises²² and organizational change in response to the COVID-19 pandemic.²³ Due to the paucity of available information, the authors undertook a pilot quality improvement (QI) initiative to address this knowledge gap.

The aim of this initiative was to gain a better understanding of the challenges experienced, lessons learned, and recommendations to be shared by VHA medical center directors (MCDs) of health care facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The authors hope that this information will help health care leaders across both governmental and nongovernmental organizations, nationally and globally, to prepare for future pandemics, other unanticipated crises (eg, natural disasters, terrorist attacks), and major change initiatives (eg, electronic health record modernization) that may affect the delivery of safe, high-quality, and effective patient care. The initiative is described using the SQUIRE 2.0 guidelines.^24,25

Methods

Survey

We used a qualitative approach and administered a confidential web-based survey, developed by the project team, to VHA MCDs at facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The survey consisted of 8 participant characteristic questions (Table 1) and 4 open-ended questions. The open-ended questions were designed to encourage MCD participants to freely provide detailed descriptions of the challenges experienced, lessons learned, recommendations for other health care leaders, and any additional information they believed was relevant.^26,27 Participants were asked to respond to the following items:

1. Please describe any challenges you experienced while in the role of MCD at a facility that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic.

1. What are some lessons that you learned when responding to the COVID-19 pandemic while on the journey to high reliability?
2. What recommendations would you like to make to other health care leaders to enable them to respond effectively to crises while on the journey to high reliability?
3. Please provide any additional information that would be of value.

An invitation to participate in this pilot QI initiative was sent via e-mail to 35 potential participants, who were all MCDs at Cohort 1 and Cohort 2 facilities. The invitation was sent on June 17, 2022, by a VHA senior High Reliability Enterprise Support government team member not directly involved with the initiative. The participants were given 3 weeks to complete the survey. A reminder was sent at the end of week 1 and the beginning of week 3. The VHA MCDs from Cohort 1 (n = 17) began the HRO journey in February 2019 and those in Cohort 2 (n = 18) initiated the HRO journey in October 2020. Because the VHA is the largest integrated health care system in the United States, the potential participants were geographically dispersed. Examples of locations in Cohort 1 include Manchester Veterans Affairs Medical Center (VAMC) in New Hampshire, Ralph H. Johnson VAMC in Charleston, South Carolina, and Boise VAMC, in Idaho. Examples of Cohort 2 locations include Chillicothe VAMC in Ohio, Marion VAMC in Indiana, and John D. Dingell VAMC in Detroit, Michigan.

The invitation included the objective of the initiative, estimated time to complete the confidential web-based survey, time allotted for responses to be submitted, and a link to the survey should potential participants agree to participate. Potential participants were informed that their involvement was voluntary, based on their willingness to participate and available time to complete the survey. Finally, the invitation noted that any comments provided would remain confidential and nonattributional for the purpose of publishing and presenting. The inclusion criteria for participation were: (1) serving in the role of MCD of an organization that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic; (2) voluntary participation; and (3) thorough responses provided to the 4 open-ended and 8 participant characteristic questions, according to the instructions provided.

Data Gathering and Analysis

To minimize bias and maintain neutrality at the organizational level, only non-VHA individuals working on the project were directly involved with participants’ data review and analysis. Participant characteristics were analyzed using descriptive statistics. Responses to the 4 open-ended questions were coded and analyzed by an experienced researcher and coauthor using NVivo 11 qualitative data analysis software.²⁸ To ensure trustworthiness (credibility, transferability, dependability, and confirmability) in the data analysis procedure,²⁹ inductive thematic analysis was also performed manually using the methodologies of Braun and Clarke (Table 2)³⁰ and Erlingsson and Brysiewicz.³¹ The goal of inductive analysis is to allow themes to emerge from the data while minimizing preconceptions.^32,33 Regular team meetings were held to discuss and review the progress of data collection and analysis. The authors agreed that the themes were representative of the participants’ responses.

Institutional review board (IRB) review and approval were not required, as this project was a pilot QI initiative. The intent of the initiative was to explore ways to improve the quality of care delivered in the participants’ local care settings and not to generalize the findings. Under these circumstances, formal IRB review and approval of a QI initiative are not required.³⁴ Participation in this pilot QI initiative was voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent. Confidentiality was ensured at all times by avoiding both the use of facility names and the collection of participant identifiers. Unique numbers were assigned to each participant. All comments provided by survey participants remained confidential and nonattributional for the purpose of publishing and presenting.

Results

Of the 35 potential participants, 15 VHA MCDs (43%) completed the confidential web-based survey. Out of the 17 potential participants in Cohort 1, 6 (35%) completed the survey. With Cohort 2, 9 (50%) of the potential 18 participants responded. Although saturation was reached at 10 responses, the additional completed surveys were included in the analysis. Saturation can be achieved with a small number of participants (n = 9–17), particularly when the potential participants are relatively homogenous and project aims are narrowly defined.³⁵ Most participants had more than 10 years of executive-level experience and most medical centers had been on the journey to high reliability for more than 12 months at the time of the pandemic (Table 3). Five major themes emerged from the participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum. In the following sections, the numbers in parentheses after the direct quotes represent the unique numbers assigned to the participant providing the response.

Managing Competing Priorities

When analyzing the responses to question 1, a recurring theme from 7 participants (Cohort 1, n = 4; Cohort 2, n = 3) related to challenges encountered while continuing the journey to high reliability during COVID-19 was managing competing priorities. Although most participants reported extensive previous leadership experience, some did not feel prepared for the complexity, uncertainty, challenges, and multitude of competing priorities facing the journey to high reliability during the COVID-19 pandemic. One participant succinctly noted:

“There were too many competing priorities dealing with the pandemic and staffing crisis.” (Participant 8)

Other participants shared:

“We had our HRO mentor designated just as our first peak was descending on us. It was initially challenging to determine the proper pace of implementation when we clearly had other things going on. There was a real risk that people would say, ‘What, are you kidding?’ as we tried to roll this out.” (Participant 4)

“Prior to COVID, our main challenges were getting organized and operational rollout. During the pandemic, we had to shift our focus to COVID and the training aspects suffered. Also, many other priorities pulled us away from an HRO rollout focus.” (Participant 6)

Staying Committed

When examining the question 2 responses, 1 theme that resonated most when it came to lessons learned, shared by 6 participants (Cohort 1, n = 4; Cohort 2, n = 2), was the need to stay committed to HRO, despite the unprecedented crisis at hand. A number of participants eloquently noted how important it was stay committed to the HRO journey during the COVID-19 pandemic:

“If you don’t need a highly reliable organization during a crisis, when do you need it? That was the message that we kicked off with. It was also VERY important to take things slowly. Education had to be done in bits, and we had a much more modest timeline than what would have been the norm for any initiative pre-COVID. The emphasis was on this being a long-term commitment, that we would be doing it the right way rather than rushing it, etc.” (Participant 4)

“Keeping HRO principles and a Just Culture on the forefront of our minds, we looked for opportunities to progress on our HRO journey, despite the challenges of the pandemic. Our monthly Town Halls became weekly events to share COVID updates and information with staff. We used the Town Halls to promote our HRO mission and to open communication lines with staff, designating 1 week each month as a ‘Safety Forum.’ The pandemic provided the springboard and backdrop for staff Safety Stories submissions, many of which were shared at our Town Halls and Safety Forums.” (Participant 7)

“We were able to utilize HRO principles in response to the COVID pandemic. Specifically standardized communication from the facility to VISN [Veterans Integrated Services Network] was initiated on a daily basis. This practice provided daily communication on key operational items and clinical items at the medical center, allowed timely feedback on actions being taken, as was instrumental in daily checks on staffing, COVID testing supplies, overall supply chain issues.” (Participant 9)

Adapting and Overcoming

The recommendations provided by 10 participants (Cohort 1, n = 6; Cohort 2, n = 4) for other health care leaders experiencing a crisis during the journey to high reliability were insightful. The themes that frequently emerged from the responses to the survey were to adapt and overcome. Participants shared:

“Utilize the many tools you’re given, specifically your team. Try even the craziest ideas from frontline staff.” (Participant 1)

“Use your mentors for younger directors and, even if you think you know the answer, involve your staff. It makes them feel they have a voice and gives them ownership of the issues.” (Participant 5)

“Make sure that you have key leaders in place who are committed to HRO and can help the organization adjust.” (Participant 6)

“Take advantage of HRO Leader Coaching, which pairs MCDs with coaches who act as consultants for HRO leadership practices to ensure progress in reaching the next level in the journey to High Reliability.” (Participant 7)

“Meet regularly with the HRO Lead and team (more frequently during early stages of implementation) to provide support, eliminate barriers, and champion the HRO mission. It is important to include other members of the ELT [Executive Leadership Team] to ensure their involvement with the facility HRO strategic plan.” (Participant 7)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

Prioritizing Competing Demands

The theme of prioritizing competing demands emerged again from 5 participants (Cohort 1, n = 3; Cohort 2, n = 2) with question 3 describing recommendations for other leaders:

“Your first priority is to the crisis. Don’t get distracted by this or any other initiative. That was not a very popular message for the people pushing HRO, but it is the reality and the necessity. However, it IS possible to move forward with HRO (or other important initiatives) during crisis times, as long as you carefully consider what you are asking of people and don’t overload/overwhelm them. It is not your ego (or that of Central Office) that needs to be stoked. If the initiative truly has value, you need to be patient to see it done properly, rather than rushed/pushed/forced. Don’t kill it by being overeager and overwhelming your already overtaxed people. That said, keep moving forward. The key is pacing—and remember that your Type A hard-driving leader types (you know who you are) will certainly fail if they push it. Or even if they go at a normal pace that would be appropriate for noncrisis times.” (Participant 4)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

“It was critical for us to always focus on the immediate workplace safety of staff (especially those on the frontlines of the pandemic response) when in the process of rolling out HRO initiatives.” (Participant 14)

Maintaining Momentum

When analyzing additional information that participants thought would be of value, 3 participants (Cohort 1, n=2; Cohort 2, n=1) noted the importance of maintaining momentum with HRO during a crisis:

“It seemed as though communication and education from VHA on HRO slowed down at the same time, which further slowed our progress. We are now trying to ramp our engagement up again.” (Participant 3)

“There can be synergy between crisis response and HRO implementation. As an example, one of the first steps we took was leadership rounding. That was necessary anyways for crisis management (raising the spirits on the front lines, so to speak). What we did was include scheduled time instead of (in addition to) ad hoc. And we got credit for taking an HRO step. I resisted whiteboards/visual management systems for a long time because (in my opinion) that would have been much too distracting during the crisis. Having waited for better times, I was able to move forward with that several months later and with good success.” (Participant 4)

Discussion

Health care leaders worldwide experienced an immense set of challenges because of the COVID-19 pandemic, which is a crisis of a magnitude with no parallel in modern times. Strong, adaptive leadership at all levels of health care systems was needed to effectively address the immense crisis at hand.^36,37 Findings from this pilot QI initiative suggest that MCDs faced many new challenges, requiring them to perform unfamiliar tasks and manage numerous overlapping challenges (eg, staffing shortages and reassignments, safety concerns, changes to patient appointments, backlogs in essential services), all while also trying to continue with the journey to high reliability. Despite the challenges leaders faced, they recognized the need to manage competing priorities early and effectively. At times, the priority was to address the wide-ranging, urgent issues related to the pandemic. When the conditions improved, there was time to refocus efforts on important but longer-term activities related to the HRO journey. Other participants recognized that their commitment to HRO needed to remain a priority even during the periods of intense focus on COVID-19. These participants continuously looked for ways to integrate HRO principles and practices into their response to the extraordinary challenges of the pandemic. Emerging research highlights how leaders had to modify their day-to-day responsibilities because of the wide disruptions caused by the COVID-19 pandemic, even when not on the journey to becoming an HRO.^36,37

Some participants felt compelled to stay committed to the HRO journey despite numerous competing demands. They stayed committed to looking for opportunities to progress by implementing HRO principles and practices to achieve safety, quality, and efficiency goals. This dedication is noteworthy, especially in light of recently published research that demonstrates the vast number of patient safety issues that presented during the COVID-19 pandemic (eg, ineffective communication, poor teamwork, the absence of coordination)¹ as well as perceptions that patient safety and quality of care had significantly declined as a result of the crisis.^36,37

Participants also highlighted the need to be adaptive when responding to the complexity and unpredictability of the pandemic. Participants regularly sought ways to increase their knowledge, skills, and abilities by using the resources (eg, tools, experts) available to them. Research shows that in increasingly complex and ever-changing situation such as the COVID-19 pandemic, leaders must be adaptive with all levels of performance, especially when limited information is available.^38,39

This is the first initiative of its kind to specifically explore the challenges experienced and lessons learned from health care leaders continuing along the journey to high reliability during the COVID-19 pandemic. Findings from this pilot QI initiative revealed that many participants recommended that leaders adapt and overcome challenges as much as possible when continuing with HRO during a crisis. These findings are echoed in the current literature suggesting that adaptive performance is a highly effective form of leadership during crises.^38,40 Being able to effectively adapt during a crisis is essential for reducing further vulnerabilities across health care systems. In fact, this lesson is shared by many countries in response to the unprecedented global crisis.⁴¹A limitation of this pilot QI initiative is that the authors did not directly solicit responses from all VHA MCDs or from other health care executives (eg, Chief of Staff, Associate Director for Operations, Associate Director for Patient Care, and Nurse Executive). As such, our findings represent only a small segment of senior leadership perspectives from a large, integrated health care system. Individuals who did not respond to the survey may have had different experiences than those who did, and the authors excluded many MCDs who formally began their HRO journeys in 2022, well after the pandemic was underway. Similarly, the experiences of Veterans Affairs leaders may or may not be similar to that of other health care organizations. Although the goal of this initiative was to explore the participants’ experiences during the period of crisis, time and distance from the events at the height of the COVID-19 pandemic may have resulted in difficulty recalling information as well as making sense of the occurrence. This potential recall bias is a common occurrence in trying to explore past experiences, especially as they relate to crises. Finally, this pilot QI initiative did not explore personal challenges participants may have faced during this period of time (eg, burnout, personal or family illness), which may have also shaped their responses.

Conclusion

This initiative suggests that VHA MCDs often relied on HRO principles to guide and assist with their response to the COVID-19 pandemic, including managing periods of unprecedented crisis. The ability to adapt and prioritize was seen as an especially important lesson. Many MCDs continued their personal and organizational efforts toward high reliability even in periods of intense challenge because of the pandemic. These findings can help with future crises that may occur during an organization’s journey to high reliability. This pilot QI initiative’s findings warrant further investigation to explore the experiences of the broader range of health care leaders while responding to unplanned crises or even planned large-scale cultural change or technology modernization initiatives (eg, electronic health record modernization) to expand the state of the science of high reliability as well as inform policy and decision-making. Finally, another area for future study is examining how leadership responses vary across facilities, depending on factors such as leader roles, facility complexity level, resource availability, patient population characteristics, and organizational culture.

Acknowledgment: The authors express their sincere gratitude to the medical center directors who participated in this pilot study.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel St., Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

From the U.S. Department of Veterans Affairs (all authors), and Cognosante, LLC, Falls Church, VA (Dr. Murray, Dr. Sawyer, and Jessica Fankhauser).

Abstract

Objective: The COVID-19 pandemic posed unprecedented leadership challenges to health care organizations worldwide, especially those on the journey to high reliability. The objective of this pilot quality improvement initiative was to describe the experiences of medical center leaders continuing along the journey to high reliability during the pandemic.

Methods: A convenience sample of Veterans Health Administration medical center directors at facilities that had initiated the journey to high reliability prior to or during the COVID-19 pandemic were asked to complete a confidential survey to explore the challenges experienced and lessons learned.

Results: Of the 35 potential participants, 15 completed the confidential web-based survey. Five major themes emerged from participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum.

Conclusion: This pilot quality improvement initiative provides some insight into the challenges experienced and lessons learned during the COVID-19 pandemic to help inform health care leaders’ responses during crises they may encounter along the journey to becoming a high reliability organization.

Keywords: HRO, leadership, patient safety.

Health care leaders worldwide agree that the COVID-19 pandemic has presented one of the most challenging leadership tests encountered in many generations,^1,2 creating a widespread crisis of unprecedented scope and scale for health care systems globally.^2,3 COVID-19 has posed many challenges and obstacles for health care leaders, including overworked, overstressed, and socially isolated employees; expedited hiring to ensure adequate staffing; reallocation of employees to other units; supply shortages such as personal protective equipment; changing polices related to safety protocols; modifying operations; reorganizing facilities to care for large volumes of critically ill patients; and ethical challenges.^4-8 Health care systems were required to create and implement new clinical, operational, and staffing protocols that extended capabilities far beyond conventional standards of care and crisis response operations.⁹ To provide a picture of the impact of COVID-19 on the Veterans Health Administration (VHA), as of March 3, 2023, the VHA has fully vaccinated more than 4.7 million individuals, including 4.3 million veterans and 320,936 federal employees.^10,11

Maintaining continuous progress toward advancing high reliability organization (HRO) principles and practices can be especially challenging during crises of unprecedented scale such as the pandemic. HROs must be continually focused on achieving safety, quality, and efficiency goals by attending to the 3 pillars of HRO: culture, leadership, and continuous process improvement. HROs promote a culture where all staff across the organization watch for and report any unsafe conditions before these conditions pose a greater risk in the workplace. Hospital leaders, from executives to frontline managers, must be cognizant of all systems and processes that have the potential to affect patient care.¹² All of the principles of HROs must continue without fail to ensure patient safety; these principles include preoccupation with failure, anticipating unexpected risks, sensitivity to dynamic and ever-changing operations, avoiding oversimplifications of identified problems, fostering resilience across the organization, and deferring to those with the expertise to make the best decisions regardless of position, rank, or title.^12,13 Given the demands faced by leaders during crises with unprecedented disruption to normal operating procedures, it can be especially difficult to identify systemic challenges and apply lessons learned in a timely manner. However, it is critical to identify such lessons in order to continuously improve and to increase preparedness for subsequent crises.^13,14

Because of the COVID-19 pandemic’s unprecedented nature in recent history, a review of the literature produced little evidence exploring the challenges experienced and lessons learned by health care leaders, especially as it relates to implementing or sustaining HRO journeys during the COVID-19 pandemic. Related literature published to date consists of editorials on reliability, uncertainty, and the management of errors¹⁵; patient safety and high reliability preventive strategies¹⁶; and authentic leadership.¹⁷ Five viewpoints were published on HROs and maladaptive stress behaviors,¹⁸ mindful organizing and organizational reliability,¹⁹ the practical essence of HROs,²⁰ embracing principles of HROs in crisis,⁸ and using observation and high reliability strategies when facing an unprecedented safety threat.²¹ Finally, the authors identified 2 studies that used a qualitative research approach to explore leadership functions within an HRO when managing crises²² and organizational change in response to the COVID-19 pandemic.²³ Due to the paucity of available information, the authors undertook a pilot quality improvement (QI) initiative to address this knowledge gap.

The aim of this initiative was to gain a better understanding of the challenges experienced, lessons learned, and recommendations to be shared by VHA medical center directors (MCDs) of health care facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The authors hope that this information will help health care leaders across both governmental and nongovernmental organizations, nationally and globally, to prepare for future pandemics, other unanticipated crises (eg, natural disasters, terrorist attacks), and major change initiatives (eg, electronic health record modernization) that may affect the delivery of safe, high-quality, and effective patient care. The initiative is described using the SQUIRE 2.0 guidelines.^24,25

Methods

Survey

We used a qualitative approach and administered a confidential web-based survey, developed by the project team, to VHA MCDs at facilities that had initiated the journey to high reliability before or during the COVID-19 pandemic. The survey consisted of 8 participant characteristic questions (Table 1) and 4 open-ended questions. The open-ended questions were designed to encourage MCD participants to freely provide detailed descriptions of the challenges experienced, lessons learned, recommendations for other health care leaders, and any additional information they believed was relevant.^26,27 Participants were asked to respond to the following items:

1. Please describe any challenges you experienced while in the role of MCD at a facility that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic.

1. What are some lessons that you learned when responding to the COVID-19 pandemic while on the journey to high reliability?
2. What recommendations would you like to make to other health care leaders to enable them to respond effectively to crises while on the journey to high reliability?
3. Please provide any additional information that would be of value.

An invitation to participate in this pilot QI initiative was sent via e-mail to 35 potential participants, who were all MCDs at Cohort 1 and Cohort 2 facilities. The invitation was sent on June 17, 2022, by a VHA senior High Reliability Enterprise Support government team member not directly involved with the initiative. The participants were given 3 weeks to complete the survey. A reminder was sent at the end of week 1 and the beginning of week 3. The VHA MCDs from Cohort 1 (n = 17) began the HRO journey in February 2019 and those in Cohort 2 (n = 18) initiated the HRO journey in October 2020. Because the VHA is the largest integrated health care system in the United States, the potential participants were geographically dispersed. Examples of locations in Cohort 1 include Manchester Veterans Affairs Medical Center (VAMC) in New Hampshire, Ralph H. Johnson VAMC in Charleston, South Carolina, and Boise VAMC, in Idaho. Examples of Cohort 2 locations include Chillicothe VAMC in Ohio, Marion VAMC in Indiana, and John D. Dingell VAMC in Detroit, Michigan.

The invitation included the objective of the initiative, estimated time to complete the confidential web-based survey, time allotted for responses to be submitted, and a link to the survey should potential participants agree to participate. Potential participants were informed that their involvement was voluntary, based on their willingness to participate and available time to complete the survey. Finally, the invitation noted that any comments provided would remain confidential and nonattributional for the purpose of publishing and presenting. The inclusion criteria for participation were: (1) serving in the role of MCD of an organization that initiated implementation of HRO principles and practices prior to (February 2020) or during (March 2020–September 2021) the initial onset of the COVID-19 pandemic; (2) voluntary participation; and (3) thorough responses provided to the 4 open-ended and 8 participant characteristic questions, according to the instructions provided.

Data Gathering and Analysis

To minimize bias and maintain neutrality at the organizational level, only non-VHA individuals working on the project were directly involved with participants’ data review and analysis. Participant characteristics were analyzed using descriptive statistics. Responses to the 4 open-ended questions were coded and analyzed by an experienced researcher and coauthor using NVivo 11 qualitative data analysis software.²⁸ To ensure trustworthiness (credibility, transferability, dependability, and confirmability) in the data analysis procedure,²⁹ inductive thematic analysis was also performed manually using the methodologies of Braun and Clarke (Table 2)³⁰ and Erlingsson and Brysiewicz.³¹ The goal of inductive analysis is to allow themes to emerge from the data while minimizing preconceptions.^32,33 Regular team meetings were held to discuss and review the progress of data collection and analysis. The authors agreed that the themes were representative of the participants’ responses.

Institutional review board (IRB) review and approval were not required, as this project was a pilot QI initiative. The intent of the initiative was to explore ways to improve the quality of care delivered in the participants’ local care settings and not to generalize the findings. Under these circumstances, formal IRB review and approval of a QI initiative are not required.³⁴ Participation in this pilot QI initiative was voluntary, and participants could withdraw at any time without consequences. Completion of the survey indicated consent. Confidentiality was ensured at all times by avoiding both the use of facility names and the collection of participant identifiers. Unique numbers were assigned to each participant. All comments provided by survey participants remained confidential and nonattributional for the purpose of publishing and presenting.

Results

Of the 35 potential participants, 15 VHA MCDs (43%) completed the confidential web-based survey. Out of the 17 potential participants in Cohort 1, 6 (35%) completed the survey. With Cohort 2, 9 (50%) of the potential 18 participants responded. Although saturation was reached at 10 responses, the additional completed surveys were included in the analysis. Saturation can be achieved with a small number of participants (n = 9–17), particularly when the potential participants are relatively homogenous and project aims are narrowly defined.³⁵ Most participants had more than 10 years of executive-level experience and most medical centers had been on the journey to high reliability for more than 12 months at the time of the pandemic (Table 3). Five major themes emerged from the participants’ responses: (1) managing competing priorities, (2) staying committed, (3) adapting and overcoming, (4) prioritizing competing demands, and (5) maintaining momentum. In the following sections, the numbers in parentheses after the direct quotes represent the unique numbers assigned to the participant providing the response.

Managing Competing Priorities

When analyzing the responses to question 1, a recurring theme from 7 participants (Cohort 1, n = 4; Cohort 2, n = 3) related to challenges encountered while continuing the journey to high reliability during COVID-19 was managing competing priorities. Although most participants reported extensive previous leadership experience, some did not feel prepared for the complexity, uncertainty, challenges, and multitude of competing priorities facing the journey to high reliability during the COVID-19 pandemic. One participant succinctly noted:

“There were too many competing priorities dealing with the pandemic and staffing crisis.” (Participant 8)

Other participants shared:

“We had our HRO mentor designated just as our first peak was descending on us. It was initially challenging to determine the proper pace of implementation when we clearly had other things going on. There was a real risk that people would say, ‘What, are you kidding?’ as we tried to roll this out.” (Participant 4)

“Prior to COVID, our main challenges were getting organized and operational rollout. During the pandemic, we had to shift our focus to COVID and the training aspects suffered. Also, many other priorities pulled us away from an HRO rollout focus.” (Participant 6)

Staying Committed

When examining the question 2 responses, 1 theme that resonated most when it came to lessons learned, shared by 6 participants (Cohort 1, n = 4; Cohort 2, n = 2), was the need to stay committed to HRO, despite the unprecedented crisis at hand. A number of participants eloquently noted how important it was stay committed to the HRO journey during the COVID-19 pandemic:

“If you don’t need a highly reliable organization during a crisis, when do you need it? That was the message that we kicked off with. It was also VERY important to take things slowly. Education had to be done in bits, and we had a much more modest timeline than what would have been the norm for any initiative pre-COVID. The emphasis was on this being a long-term commitment, that we would be doing it the right way rather than rushing it, etc.” (Participant 4)

“Keeping HRO principles and a Just Culture on the forefront of our minds, we looked for opportunities to progress on our HRO journey, despite the challenges of the pandemic. Our monthly Town Halls became weekly events to share COVID updates and information with staff. We used the Town Halls to promote our HRO mission and to open communication lines with staff, designating 1 week each month as a ‘Safety Forum.’ The pandemic provided the springboard and backdrop for staff Safety Stories submissions, many of which were shared at our Town Halls and Safety Forums.” (Participant 7)

“We were able to utilize HRO principles in response to the COVID pandemic. Specifically standardized communication from the facility to VISN [Veterans Integrated Services Network] was initiated on a daily basis. This practice provided daily communication on key operational items and clinical items at the medical center, allowed timely feedback on actions being taken, as was instrumental in daily checks on staffing, COVID testing supplies, overall supply chain issues.” (Participant 9)

Adapting and Overcoming

The recommendations provided by 10 participants (Cohort 1, n = 6; Cohort 2, n = 4) for other health care leaders experiencing a crisis during the journey to high reliability were insightful. The themes that frequently emerged from the responses to the survey were to adapt and overcome. Participants shared:

“Utilize the many tools you’re given, specifically your team. Try even the craziest ideas from frontline staff.” (Participant 1)

“Use your mentors for younger directors and, even if you think you know the answer, involve your staff. It makes them feel they have a voice and gives them ownership of the issues.” (Participant 5)

“Make sure that you have key leaders in place who are committed to HRO and can help the organization adjust.” (Participant 6)

“Take advantage of HRO Leader Coaching, which pairs MCDs with coaches who act as consultants for HRO leadership practices to ensure progress in reaching the next level in the journey to High Reliability.” (Participant 7)

“Meet regularly with the HRO Lead and team (more frequently during early stages of implementation) to provide support, eliminate barriers, and champion the HRO mission. It is important to include other members of the ELT [Executive Leadership Team] to ensure their involvement with the facility HRO strategic plan.” (Participant 7)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

Prioritizing Competing Demands

The theme of prioritizing competing demands emerged again from 5 participants (Cohort 1, n = 3; Cohort 2, n = 2) with question 3 describing recommendations for other leaders:

“Your first priority is to the crisis. Don’t get distracted by this or any other initiative. That was not a very popular message for the people pushing HRO, but it is the reality and the necessity. However, it IS possible to move forward with HRO (or other important initiatives) during crisis times, as long as you carefully consider what you are asking of people and don’t overload/overwhelm them. It is not your ego (or that of Central Office) that needs to be stoked. If the initiative truly has value, you need to be patient to see it done properly, rather than rushed/pushed/forced. Don’t kill it by being overeager and overwhelming your already overtaxed people. That said, keep moving forward. The key is pacing—and remember that your Type A hard-driving leader types (you know who you are) will certainly fail if they push it. Or even if they go at a normal pace that would be appropriate for noncrisis times.” (Participant 4)

“Prioritize and understand that not everything is priority #1. Continue what you can with HRO, incorporate high reliability principles into the work being done during a crisis, but understand you may need to modify rollout schedules.” (Participant 8)

“It was critical for us to always focus on the immediate workplace safety of staff (especially those on the frontlines of the pandemic response) when in the process of rolling out HRO initiatives.” (Participant 14)

Maintaining Momentum

When analyzing additional information that participants thought would be of value, 3 participants (Cohort 1, n=2; Cohort 2, n=1) noted the importance of maintaining momentum with HRO during a crisis:

“It seemed as though communication and education from VHA on HRO slowed down at the same time, which further slowed our progress. We are now trying to ramp our engagement up again.” (Participant 3)

“There can be synergy between crisis response and HRO implementation. As an example, one of the first steps we took was leadership rounding. That was necessary anyways for crisis management (raising the spirits on the front lines, so to speak). What we did was include scheduled time instead of (in addition to) ad hoc. And we got credit for taking an HRO step. I resisted whiteboards/visual management systems for a long time because (in my opinion) that would have been much too distracting during the crisis. Having waited for better times, I was able to move forward with that several months later and with good success.” (Participant 4)

Discussion

Health care leaders worldwide experienced an immense set of challenges because of the COVID-19 pandemic, which is a crisis of a magnitude with no parallel in modern times. Strong, adaptive leadership at all levels of health care systems was needed to effectively address the immense crisis at hand.^36,37 Findings from this pilot QI initiative suggest that MCDs faced many new challenges, requiring them to perform unfamiliar tasks and manage numerous overlapping challenges (eg, staffing shortages and reassignments, safety concerns, changes to patient appointments, backlogs in essential services), all while also trying to continue with the journey to high reliability. Despite the challenges leaders faced, they recognized the need to manage competing priorities early and effectively. At times, the priority was to address the wide-ranging, urgent issues related to the pandemic. When the conditions improved, there was time to refocus efforts on important but longer-term activities related to the HRO journey. Other participants recognized that their commitment to HRO needed to remain a priority even during the periods of intense focus on COVID-19. These participants continuously looked for ways to integrate HRO principles and practices into their response to the extraordinary challenges of the pandemic. Emerging research highlights how leaders had to modify their day-to-day responsibilities because of the wide disruptions caused by the COVID-19 pandemic, even when not on the journey to becoming an HRO.^36,37

Some participants felt compelled to stay committed to the HRO journey despite numerous competing demands. They stayed committed to looking for opportunities to progress by implementing HRO principles and practices to achieve safety, quality, and efficiency goals. This dedication is noteworthy, especially in light of recently published research that demonstrates the vast number of patient safety issues that presented during the COVID-19 pandemic (eg, ineffective communication, poor teamwork, the absence of coordination)¹ as well as perceptions that patient safety and quality of care had significantly declined as a result of the crisis.^36,37

Participants also highlighted the need to be adaptive when responding to the complexity and unpredictability of the pandemic. Participants regularly sought ways to increase their knowledge, skills, and abilities by using the resources (eg, tools, experts) available to them. Research shows that in increasingly complex and ever-changing situation such as the COVID-19 pandemic, leaders must be adaptive with all levels of performance, especially when limited information is available.^38,39

This is the first initiative of its kind to specifically explore the challenges experienced and lessons learned from health care leaders continuing along the journey to high reliability during the COVID-19 pandemic. Findings from this pilot QI initiative revealed that many participants recommended that leaders adapt and overcome challenges as much as possible when continuing with HRO during a crisis. These findings are echoed in the current literature suggesting that adaptive performance is a highly effective form of leadership during crises.^38,40 Being able to effectively adapt during a crisis is essential for reducing further vulnerabilities across health care systems. In fact, this lesson is shared by many countries in response to the unprecedented global crisis.⁴¹A limitation of this pilot QI initiative is that the authors did not directly solicit responses from all VHA MCDs or from other health care executives (eg, Chief of Staff, Associate Director for Operations, Associate Director for Patient Care, and Nurse Executive). As such, our findings represent only a small segment of senior leadership perspectives from a large, integrated health care system. Individuals who did not respond to the survey may have had different experiences than those who did, and the authors excluded many MCDs who formally began their HRO journeys in 2022, well after the pandemic was underway. Similarly, the experiences of Veterans Affairs leaders may or may not be similar to that of other health care organizations. Although the goal of this initiative was to explore the participants’ experiences during the period of crisis, time and distance from the events at the height of the COVID-19 pandemic may have resulted in difficulty recalling information as well as making sense of the occurrence. This potential recall bias is a common occurrence in trying to explore past experiences, especially as they relate to crises. Finally, this pilot QI initiative did not explore personal challenges participants may have faced during this period of time (eg, burnout, personal or family illness), which may have also shaped their responses.

Conclusion

This initiative suggests that VHA MCDs often relied on HRO principles to guide and assist with their response to the COVID-19 pandemic, including managing periods of unprecedented crisis. The ability to adapt and prioritize was seen as an especially important lesson. Many MCDs continued their personal and organizational efforts toward high reliability even in periods of intense challenge because of the pandemic. These findings can help with future crises that may occur during an organization’s journey to high reliability. This pilot QI initiative’s findings warrant further investigation to explore the experiences of the broader range of health care leaders while responding to unplanned crises or even planned large-scale cultural change or technology modernization initiatives (eg, electronic health record modernization) to expand the state of the science of high reliability as well as inform policy and decision-making. Finally, another area for future study is examining how leadership responses vary across facilities, depending on factors such as leader roles, facility complexity level, resource availability, patient population characteristics, and organizational culture.

Acknowledgment: The authors express their sincere gratitude to the medical center directors who participated in this pilot study.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel St., Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

This year marks the publication of the 30th volume of the Journal of Clinical Outcomes Management (JCOM). As we celebrate JCOM’s 30th year, we look forward to the future and continuing the journey to inform quality improvement leaders and practitioners about advances in the field and share experiences. The path forward on this journey involves collaboration across stakeholders, the application of innovative improvement methods, and a commitment to achieving health equity. Health care quality improvement plans must prioritize patient-centered care, promote evidence-based practices and continuous learning, and establish clear metrics to measure progress and success. Furthermore, engagement with patients and communities must be at the forefront of any quality improvement plan, as their perspectives and experiences are essential to understanding and addressing the root causes of disparities in health care delivery. Additionally, effective communication and coordination among health care providers, administrators, policymakers, and other stakeholders are crucial to achieving sustainable improvements in health care quality.

JCOM’s mission is to serve as a platform for sharing knowledge, experiences, and best practices to improve patient outcomes and promote health equity. The vision encompasses a world where all individuals have access to high-quality, patient-centered health care that is free of disparities and achieves optimal health outcomes. JCOM’s strategy is to publish articles that showcase innovative quality improvement initiatives, share evidence-based practices and research findings, highlight successful collaborations, and provide practical guidance for health care professionals to implement quality improvement initiatives in their organizations.

We believe that by sharing these insights and experiences, we can accelerate progress toward achieving equitable and high-quality health care for all individuals and communities, regardless of their socioeconomic status, race/ethnicity, gender identity, or any other factor that may impact their access to care and health outcomes. We continue to welcome submissions from all health care professionals, researchers, and other stakeholders involved in quality improvement initiatives. Together, we can work toward a future where every individual has access to the highest quality of health care and experiences equitable health outcomes.

A comprehensive and collaborative approach to health care quality improvement, which is led by a peer review process and scientific publication of the progress, is a necessary part of ensuring that all patients receive high-quality care that is equitable and patient-centered. The future of health care quality will require further research and scholarly work in the areas of training and development, data infrastructure and analytics, as well as technology-enabled solutions that support continuous improvement and innovation. Health care organizations can build a culture of quality improvement that drives meaningful progress toward achieving health equity and improving health care delivery for all by sharing the output from their research.

Thank you for joining us in this mission to improve health care quality, promote optimal health care delivery methods, and create a world where health care is not only accessible, but also equitable and of the highest standards. Let us continue to work toward building a health care system that prioritizes patient-centered care. Together, we can make a difference and ensure that every individual receives the care they need and deserve.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

This year marks the publication of the 30th volume of the Journal of Clinical Outcomes Management (JCOM). As we celebrate JCOM’s 30th year, we look forward to the future and continuing the journey to inform quality improvement leaders and practitioners about advances in the field and share experiences. The path forward on this journey involves collaboration across stakeholders, the application of innovative improvement methods, and a commitment to achieving health equity. Health care quality improvement plans must prioritize patient-centered care, promote evidence-based practices and continuous learning, and establish clear metrics to measure progress and success. Furthermore, engagement with patients and communities must be at the forefront of any quality improvement plan, as their perspectives and experiences are essential to understanding and addressing the root causes of disparities in health care delivery. Additionally, effective communication and coordination among health care providers, administrators, policymakers, and other stakeholders are crucial to achieving sustainable improvements in health care quality.

JCOM’s mission is to serve as a platform for sharing knowledge, experiences, and best practices to improve patient outcomes and promote health equity. The vision encompasses a world where all individuals have access to high-quality, patient-centered health care that is free of disparities and achieves optimal health outcomes. JCOM’s strategy is to publish articles that showcase innovative quality improvement initiatives, share evidence-based practices and research findings, highlight successful collaborations, and provide practical guidance for health care professionals to implement quality improvement initiatives in their organizations.

We believe that by sharing these insights and experiences, we can accelerate progress toward achieving equitable and high-quality health care for all individuals and communities, regardless of their socioeconomic status, race/ethnicity, gender identity, or any other factor that may impact their access to care and health outcomes. We continue to welcome submissions from all health care professionals, researchers, and other stakeholders involved in quality improvement initiatives. Together, we can work toward a future where every individual has access to the highest quality of health care and experiences equitable health outcomes.

A comprehensive and collaborative approach to health care quality improvement, which is led by a peer review process and scientific publication of the progress, is a necessary part of ensuring that all patients receive high-quality care that is equitable and patient-centered. The future of health care quality will require further research and scholarly work in the areas of training and development, data infrastructure and analytics, as well as technology-enabled solutions that support continuous improvement and innovation. Health care organizations can build a culture of quality improvement that drives meaningful progress toward achieving health equity and improving health care delivery for all by sharing the output from their research.

Thank you for joining us in this mission to improve health care quality, promote optimal health care delivery methods, and create a world where health care is not only accessible, but also equitable and of the highest standards. Let us continue to work toward building a health care system that prioritizes patient-centered care. Together, we can make a difference and ensure that every individual receives the care they need and deserve.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

This year marks the publication of the 30th volume of the Journal of Clinical Outcomes Management (JCOM). As we celebrate JCOM’s 30th year, we look forward to the future and continuing the journey to inform quality improvement leaders and practitioners about advances in the field and share experiences. The path forward on this journey involves collaboration across stakeholders, the application of innovative improvement methods, and a commitment to achieving health equity. Health care quality improvement plans must prioritize patient-centered care, promote evidence-based practices and continuous learning, and establish clear metrics to measure progress and success. Furthermore, engagement with patients and communities must be at the forefront of any quality improvement plan, as their perspectives and experiences are essential to understanding and addressing the root causes of disparities in health care delivery. Additionally, effective communication and coordination among health care providers, administrators, policymakers, and other stakeholders are crucial to achieving sustainable improvements in health care quality.

JCOM’s mission is to serve as a platform for sharing knowledge, experiences, and best practices to improve patient outcomes and promote health equity. The vision encompasses a world where all individuals have access to high-quality, patient-centered health care that is free of disparities and achieves optimal health outcomes. JCOM’s strategy is to publish articles that showcase innovative quality improvement initiatives, share evidence-based practices and research findings, highlight successful collaborations, and provide practical guidance for health care professionals to implement quality improvement initiatives in their organizations.

We believe that by sharing these insights and experiences, we can accelerate progress toward achieving equitable and high-quality health care for all individuals and communities, regardless of their socioeconomic status, race/ethnicity, gender identity, or any other factor that may impact their access to care and health outcomes. We continue to welcome submissions from all health care professionals, researchers, and other stakeholders involved in quality improvement initiatives. Together, we can work toward a future where every individual has access to the highest quality of health care and experiences equitable health outcomes.

A comprehensive and collaborative approach to health care quality improvement, which is led by a peer review process and scientific publication of the progress, is a necessary part of ensuring that all patients receive high-quality care that is equitable and patient-centered. The future of health care quality will require further research and scholarly work in the areas of training and development, data infrastructure and analytics, as well as technology-enabled solutions that support continuous improvement and innovation. Health care organizations can build a culture of quality improvement that drives meaningful progress toward achieving health equity and improving health care delivery for all by sharing the output from their research.

Thank you for joining us in this mission to improve health care quality, promote optimal health care delivery methods, and create a world where health care is not only accessible, but also equitable and of the highest standards. Let us continue to work toward building a health care system that prioritizes patient-centered care. Together, we can make a difference and ensure that every individual receives the care they need and deserve.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water. 

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

curtoicurto/Getty Images

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

“This is the first time the government has regulated a new chemical in drinking water in more than 30 years,” the society notes, adding, this “will require major water treatment upgrades at utilities across the country.”

Robert F. Powelson, president and CEO of the National Association of Water Companies, says addressing the PFAS in the nation’s water supply will cost “billions of dollars.”

“It’s a burden that under the current structure will disproportionately fall on water and wastewater customers in small communities and low-income families,” Mr. Powelson says in a statement. He says the onus should instead fall on “the polluters” – those who manufacture and use PFAS chemicals, who “should be held directly responsible for the clean-up costs.” 

Although the EPA is proposing a health-based maximum contaminant level goal of zero for these chemicals in drinking water, it acknowledges that this is unenforceable and so has set what it considers an enforceable level, or maximum contaminant level (MCL), of 4 parts per trillion for two of the PFAS, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). 

A different standard has been proposed for the remaining four chemicals: perfluorononanoic acid (PFNA) and hexafluoropropylene oxide dimer acid (HFPO-DA) – known together as GenX chemicals – perfluorohexane sulfonic acid (PFHxS), and perfluorobutane sulfonic acid (PFBS).

Officials from the EPA told The Washington Post that these proposed limits would be as strong or stronger than limits from about a dozen states that have set their own drinking water standards in recent years. 

“The experts here felt this was the level of stringency required to protect public health, and that the law would allow for us,” EPA Administrator Michael Regan told the newspaper. “This is a transformative action that we’re taking.”

The EPA is requesting public comment on the proposed regulation and will hold a public hearing on May 4, which members of the public can register to attend and comment on the rule proposal. The last day to register is April 28. 

The EPA wants to finalize regulation by the end of 2023, although delays are common on new rules. 

If it is fully implemented, “the rule will prevent thousands of deaths and reduce tens of thousands of serious PFAS-attributable illnesses,” the EPA statement says.

A version of this article first appeared on Medscape.com.

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water. 

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

curtoicurto/Getty Images

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

“This is the first time the government has regulated a new chemical in drinking water in more than 30 years,” the society notes, adding, this “will require major water treatment upgrades at utilities across the country.”

Robert F. Powelson, president and CEO of the National Association of Water Companies, says addressing the PFAS in the nation’s water supply will cost “billions of dollars.”

“It’s a burden that under the current structure will disproportionately fall on water and wastewater customers in small communities and low-income families,” Mr. Powelson says in a statement. He says the onus should instead fall on “the polluters” – those who manufacture and use PFAS chemicals, who “should be held directly responsible for the clean-up costs.” 

Although the EPA is proposing a health-based maximum contaminant level goal of zero for these chemicals in drinking water, it acknowledges that this is unenforceable and so has set what it considers an enforceable level, or maximum contaminant level (MCL), of 4 parts per trillion for two of the PFAS, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). 

A different standard has been proposed for the remaining four chemicals: perfluorononanoic acid (PFNA) and hexafluoropropylene oxide dimer acid (HFPO-DA) – known together as GenX chemicals – perfluorohexane sulfonic acid (PFHxS), and perfluorobutane sulfonic acid (PFBS).

Officials from the EPA told The Washington Post that these proposed limits would be as strong or stronger than limits from about a dozen states that have set their own drinking water standards in recent years. 

“The experts here felt this was the level of stringency required to protect public health, and that the law would allow for us,” EPA Administrator Michael Regan told the newspaper. “This is a transformative action that we’re taking.”

The EPA is requesting public comment on the proposed regulation and will hold a public hearing on May 4, which members of the public can register to attend and comment on the rule proposal. The last day to register is April 28. 

The EPA wants to finalize regulation by the end of 2023, although delays are common on new rules. 

If it is fully implemented, “the rule will prevent thousands of deaths and reduce tens of thousands of serious PFAS-attributable illnesses,” the EPA statement says.

A version of this article first appeared on Medscape.com.

The Environmental Protection Agency is proposing a new rule that would greatly limit the concentration of endocrine-disrupting “forever” chemicals in drinking water. 

The EPA on Tuesday announced the proposed National Primary Drinking Water Regulation (NPDWR) for six polyfluoroalkyl substances, more commonly known as PFAS, which are human-made chemicals used as oil and water repellents and coatings for common products including cookware, carpets, and textiles. Such substances are also widely used in cosmetics and food packaging.

curtoicurto/Getty Images

The Endocrine Society, which represents more than 18,000 doctors who treat hormone disorders, says it fully supports the new EPA proposal. It explains that these substances, also known as endocrine-disrupting chemicals, “do not break down when they are released into the environment, and they continue to accumulate over time. They pose health dangers at incredibly low levels and have been linked to endocrine disorders such as cancer, thyroid disruption, and reproductive difficulties.”

“This is the first time the government has regulated a new chemical in drinking water in more than 30 years,” the society notes, adding, this “will require major water treatment upgrades at utilities across the country.”

Robert F. Powelson, president and CEO of the National Association of Water Companies, says addressing the PFAS in the nation’s water supply will cost “billions of dollars.”

“It’s a burden that under the current structure will disproportionately fall on water and wastewater customers in small communities and low-income families,” Mr. Powelson says in a statement. He says the onus should instead fall on “the polluters” – those who manufacture and use PFAS chemicals, who “should be held directly responsible for the clean-up costs.” 

Although the EPA is proposing a health-based maximum contaminant level goal of zero for these chemicals in drinking water, it acknowledges that this is unenforceable and so has set what it considers an enforceable level, or maximum contaminant level (MCL), of 4 parts per trillion for two of the PFAS, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). 

A different standard has been proposed for the remaining four chemicals: perfluorononanoic acid (PFNA) and hexafluoropropylene oxide dimer acid (HFPO-DA) – known together as GenX chemicals – perfluorohexane sulfonic acid (PFHxS), and perfluorobutane sulfonic acid (PFBS).

Officials from the EPA told The Washington Post that these proposed limits would be as strong or stronger than limits from about a dozen states that have set their own drinking water standards in recent years. 

“The experts here felt this was the level of stringency required to protect public health, and that the law would allow for us,” EPA Administrator Michael Regan told the newspaper. “This is a transformative action that we’re taking.”

The EPA is requesting public comment on the proposed regulation and will hold a public hearing on May 4, which members of the public can register to attend and comment on the rule proposal. The last day to register is April 28. 

The EPA wants to finalize regulation by the end of 2023, although delays are common on new rules. 

If it is fully implemented, “the rule will prevent thousands of deaths and reduce tens of thousands of serious PFAS-attributable illnesses,” the EPA statement says.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has made changes to existing mammography regulations.

A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.

The rule requires implementation of the changes within 18 months.

According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.

For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has made changes to existing mammography regulations.

A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.

The rule requires implementation of the changes within 18 months.

According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.

For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has made changes to existing mammography regulations.

A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.

The rule requires implementation of the changes within 18 months.

According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.

For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

A version of this article first appeared on Medscape.com.

In February, the US House of Representatives hurriedly passed the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act, H.R. 139, a bill that calls into question the contributions of federal employees allowed to work from home and resets telework policies to those in place in 2019. Its author, House Oversight Committee Chairman James Comer (R, Kentucky) claimed that this change was necessary because the expansion of federal telework during the COVID-19 pandemic “has crippled the ability of agencies to get their jobs done and created backlogs.” His targets included the US Department of Veterans Affairs (VA), where, he charged, “veterans have been unable…to obtain care they have earned.” He added, “it’s hard to argue that teleworking has helped the VA.” 

While oversight of government programs is an authority of Congress, the SHOW UP Act is based on unsubstantiated assumptions of dereliction. It also disregards the devastating impact the proposed changes will have on veterans’ ability to receive care and inaccurately implies improving it. As the Senate considers the bill, they should take heed of these and other facts involving this often misunderstood form of labor.

COVID-19 irrevocably transformed the use of virtual care within the VA and across the world. Even as the pandemic subsides, public and private health care systems have continued to use telework-centered telehealth far above prepandemic levels, especially for mental health and primary care. Employers, including the VA, capitalize on telework for its benefits to both consumers and the workforce. For consumers, research supports the clinical effectiveness of telemental health service, as well as its cost-effectiveness and consumer satisfaction. On the workforce side, research has documented heightened productivity, lower distractibility, and higher job satisfaction among counselors who shifted to remote work.

Remote work also serves as a key tool in attracting and retaining a qualified workforce. As one VA service chief explained, “I am having enough trouble competing with the private sector, where extensive telework is now the norm. If telework options were rolled back, the private sector will have a field day picking off my best staff.” These comments are consistent with the data. McKinsey’s American Opportunity Survey shows that Americans have embraced remote work and want more of it. Recent data from Gallup show that 6 of 10 currently exclusively remote employees would be extremely likely to change companies if they lost their remote flexibility. Further, Gallup data show that when an employee’s location preference does not match their current work location, burnout rises, and engagement drops.   

Between 2019 and 2023, the VA’s telework expansion is what has enabled it to meet the growing demand for mental health services. VA is keeping pace by having 2 or more clinicians rotate between home and a shared VA office. Forcing these hybrid practitioners to work full time at VA facilities would drastically reduce the number of patients they can care for. There simply are not enough offices on crammed VA grounds to house staff who telework today. The net result would be that fewer appointments would be available, creating longer wait times. And that is just for existing patients. It does not factor in the expected influx due to new veteran eligibility made possible by the toxic exposures PACT Act.

Here is another good example of crucial VA telework: With the advent of the 988 Suicide & Crisis Lifeline, VA is adding more than 1000 new Veterans Crisis Line responders. All these new positions are remote. The SHOW UP Act would inhibit this expansion of lifesaving programs.

Veterans want more, not fewer, telehealth options. At a House Committee on Veterans’ Affairs hearing this past September, the VA reported that most veterans would prefer to receive mental health services virtually than to have to commute to a VA medical center or clinic. Telehealth benefits veterans in meaningful ways, including that it reduces their travel time, travel expense, depletion of sick leave, and need for childcare. Veterans with posttraumatic stress disorder, military sexual trauma, those with mobility issues, or those who struggle with the stigma of mental health treatment may prefer the familiarity of their own homes for care. Virtual options also relieve a patient’s need to enter a hospital and be unnecessarily exposed to contagious viruses. That’s safer not only for veterans but also for VA staff.

Finally, virtual care improves treatment. Research has revealed that the likelihood of missing telehealth appointments is lower than for in-person appointments. When patients miss appointments, continuity of care is disrupted, and health care outcomes are diminished. 

The pandemic is receding, but the advantages of telework-centered virtual care are greater than ever. Political representatives who want to show up for veterans should do everything in their power to expand—not cut—VA’s ability to authorize working from home.

In February, the US House of Representatives hurriedly passed the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act, H.R. 139, a bill that calls into question the contributions of federal employees allowed to work from home and resets telework policies to those in place in 2019. Its author, House Oversight Committee Chairman James Comer (R, Kentucky) claimed that this change was necessary because the expansion of federal telework during the COVID-19 pandemic “has crippled the ability of agencies to get their jobs done and created backlogs.” His targets included the US Department of Veterans Affairs (VA), where, he charged, “veterans have been unable…to obtain care they have earned.” He added, “it’s hard to argue that teleworking has helped the VA.” 

While oversight of government programs is an authority of Congress, the SHOW UP Act is based on unsubstantiated assumptions of dereliction. It also disregards the devastating impact the proposed changes will have on veterans’ ability to receive care and inaccurately implies improving it. As the Senate considers the bill, they should take heed of these and other facts involving this often misunderstood form of labor.

COVID-19 irrevocably transformed the use of virtual care within the VA and across the world. Even as the pandemic subsides, public and private health care systems have continued to use telework-centered telehealth far above prepandemic levels, especially for mental health and primary care. Employers, including the VA, capitalize on telework for its benefits to both consumers and the workforce. For consumers, research supports the clinical effectiveness of telemental health service, as well as its cost-effectiveness and consumer satisfaction. On the workforce side, research has documented heightened productivity, lower distractibility, and higher job satisfaction among counselors who shifted to remote work.

Remote work also serves as a key tool in attracting and retaining a qualified workforce. As one VA service chief explained, “I am having enough trouble competing with the private sector, where extensive telework is now the norm. If telework options were rolled back, the private sector will have a field day picking off my best staff.” These comments are consistent with the data. McKinsey’s American Opportunity Survey shows that Americans have embraced remote work and want more of it. Recent data from Gallup show that 6 of 10 currently exclusively remote employees would be extremely likely to change companies if they lost their remote flexibility. Further, Gallup data show that when an employee’s location preference does not match their current work location, burnout rises, and engagement drops.   

Between 2019 and 2023, the VA’s telework expansion is what has enabled it to meet the growing demand for mental health services. VA is keeping pace by having 2 or more clinicians rotate between home and a shared VA office. Forcing these hybrid practitioners to work full time at VA facilities would drastically reduce the number of patients they can care for. There simply are not enough offices on crammed VA grounds to house staff who telework today. The net result would be that fewer appointments would be available, creating longer wait times. And that is just for existing patients. It does not factor in the expected influx due to new veteran eligibility made possible by the toxic exposures PACT Act.

Here is another good example of crucial VA telework: With the advent of the 988 Suicide & Crisis Lifeline, VA is adding more than 1000 new Veterans Crisis Line responders. All these new positions are remote. The SHOW UP Act would inhibit this expansion of lifesaving programs.

Veterans want more, not fewer, telehealth options. At a House Committee on Veterans’ Affairs hearing this past September, the VA reported that most veterans would prefer to receive mental health services virtually than to have to commute to a VA medical center or clinic. Telehealth benefits veterans in meaningful ways, including that it reduces their travel time, travel expense, depletion of sick leave, and need for childcare. Veterans with posttraumatic stress disorder, military sexual trauma, those with mobility issues, or those who struggle with the stigma of mental health treatment may prefer the familiarity of their own homes for care. Virtual options also relieve a patient’s need to enter a hospital and be unnecessarily exposed to contagious viruses. That’s safer not only for veterans but also for VA staff.

Finally, virtual care improves treatment. Research has revealed that the likelihood of missing telehealth appointments is lower than for in-person appointments. When patients miss appointments, continuity of care is disrupted, and health care outcomes are diminished. 

The pandemic is receding, but the advantages of telework-centered virtual care are greater than ever. Political representatives who want to show up for veterans should do everything in their power to expand—not cut—VA’s ability to authorize working from home.

In February, the US House of Representatives hurriedly passed the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act, H.R. 139, a bill that calls into question the contributions of federal employees allowed to work from home and resets telework policies to those in place in 2019. Its author, House Oversight Committee Chairman James Comer (R, Kentucky) claimed that this change was necessary because the expansion of federal telework during the COVID-19 pandemic “has crippled the ability of agencies to get their jobs done and created backlogs.” His targets included the US Department of Veterans Affairs (VA), where, he charged, “veterans have been unable…to obtain care they have earned.” He added, “it’s hard to argue that teleworking has helped the VA.” 

While oversight of government programs is an authority of Congress, the SHOW UP Act is based on unsubstantiated assumptions of dereliction. It also disregards the devastating impact the proposed changes will have on veterans’ ability to receive care and inaccurately implies improving it. As the Senate considers the bill, they should take heed of these and other facts involving this often misunderstood form of labor.

COVID-19 irrevocably transformed the use of virtual care within the VA and across the world. Even as the pandemic subsides, public and private health care systems have continued to use telework-centered telehealth far above prepandemic levels, especially for mental health and primary care. Employers, including the VA, capitalize on telework for its benefits to both consumers and the workforce. For consumers, research supports the clinical effectiveness of telemental health service, as well as its cost-effectiveness and consumer satisfaction. On the workforce side, research has documented heightened productivity, lower distractibility, and higher job satisfaction among counselors who shifted to remote work.

Remote work also serves as a key tool in attracting and retaining a qualified workforce. As one VA service chief explained, “I am having enough trouble competing with the private sector, where extensive telework is now the norm. If telework options were rolled back, the private sector will have a field day picking off my best staff.” These comments are consistent with the data. McKinsey’s American Opportunity Survey shows that Americans have embraced remote work and want more of it. Recent data from Gallup show that 6 of 10 currently exclusively remote employees would be extremely likely to change companies if they lost their remote flexibility. Further, Gallup data show that when an employee’s location preference does not match their current work location, burnout rises, and engagement drops.   

Between 2019 and 2023, the VA’s telework expansion is what has enabled it to meet the growing demand for mental health services. VA is keeping pace by having 2 or more clinicians rotate between home and a shared VA office. Forcing these hybrid practitioners to work full time at VA facilities would drastically reduce the number of patients they can care for. There simply are not enough offices on crammed VA grounds to house staff who telework today. The net result would be that fewer appointments would be available, creating longer wait times. And that is just for existing patients. It does not factor in the expected influx due to new veteran eligibility made possible by the toxic exposures PACT Act.

Here is another good example of crucial VA telework: With the advent of the 988 Suicide & Crisis Lifeline, VA is adding more than 1000 new Veterans Crisis Line responders. All these new positions are remote. The SHOW UP Act would inhibit this expansion of lifesaving programs.

Veterans want more, not fewer, telehealth options. At a House Committee on Veterans’ Affairs hearing this past September, the VA reported that most veterans would prefer to receive mental health services virtually than to have to commute to a VA medical center or clinic. Telehealth benefits veterans in meaningful ways, including that it reduces their travel time, travel expense, depletion of sick leave, and need for childcare. Veterans with posttraumatic stress disorder, military sexual trauma, those with mobility issues, or those who struggle with the stigma of mental health treatment may prefer the familiarity of their own homes for care. Virtual options also relieve a patient’s need to enter a hospital and be unnecessarily exposed to contagious viruses. That’s safer not only for veterans but also for VA staff.

Finally, virtual care improves treatment. Research has revealed that the likelihood of missing telehealth appointments is lower than for in-person appointments. When patients miss appointments, continuity of care is disrupted, and health care outcomes are diminished. 

The pandemic is receding, but the advantages of telework-centered virtual care are greater than ever. Political representatives who want to show up for veterans should do everything in their power to expand—not cut—VA’s ability to authorize working from home.

New VA rule proposes to eliminate many copays for Native American veteran.

The US Department of Veterans Affairs (VA) has proposed a new rule that would waive medical copayments incurred on or after January 5, 2022, for eligible American Indian and Alaska Native (AI/AN) veterans.

The policy is intended to encourage veterans to seek regular primary care treatment, the VA says. “It’s no mystery to a lot of people that health care is sometimes hard to come by in many Native American communities,” Travis Trueblood, director of the VA Office of Tribal Health, told reporters in January. “So, this effort by VA will enhance getting people into the facilities, helping them feel welcome and getting them to use those benefits that they've earned.”

Copayments for more than 3 visits to community-based urgent care in any calendar year would still be required. Follow-up care provided by a VA-authorized primary care provider would be exempt from copays. Members of federally recognized tribes are already exempt from copays at Indian Health Service clinics.

Eligibility may be based in part on documentation issued by AI/AN tribal governments to show tribal membership. The VA has proposed the documentation requirement “as this recognizes tribal sovereignty and promotes the Nation-to-Nation relationship that exists between the United States and tribal governments.” The requirement, the notice says, is consistent with the preferences of tribal leaders.

The regulation implements a requirement in the Johnny Isakson and David P. Roe, MD, Veterans Health Care and Benefits Improvement Act of 2020, which prohibited the VA from collecting copayments from AI/AN veterans for hospital care or medical services. Senator Jon Tester (D-MT), chair of the Senate Veterans’ Affairs Committee, and Senator Jerry Moran (R-KS) introduced legislation in 2020 to enact the new policy in January 2022 , which is why the rule is retroactive.

Congress passed the measure as part of a package of veterans’ legislation at the end of 2020, and then-President Donald Trump signed it into law in January 2021. Trueblood said the nature of the federal rulemaking process makes it hard to say exactly when the change will take effect, but that no veteran will be turned away from VA care for not making a copayment, even before the rule is finalized. The VA plans to reimburse eligible veterans who received care in the past year for copayment costs.

“I’m encouraged to see VA answering my call to implement the law and remove burdensome copayments for Native veterans accessing their earned health care,” said Tester in a press release. “The fact is Native veterans have bravely answered the call to duty for generations. And I’ll continue to hold VA accountable in delivering these veterans their long-overdue support.”

New VA rule proposes to eliminate many copays for Native American veteran.

The US Department of Veterans Affairs (VA) has proposed a new rule that would waive medical copayments incurred on or after January 5, 2022, for eligible American Indian and Alaska Native (AI/AN) veterans.

The policy is intended to encourage veterans to seek regular primary care treatment, the VA says. “It’s no mystery to a lot of people that health care is sometimes hard to come by in many Native American communities,” Travis Trueblood, director of the VA Office of Tribal Health, told reporters in January. “So, this effort by VA will enhance getting people into the facilities, helping them feel welcome and getting them to use those benefits that they've earned.”

Copayments for more than 3 visits to community-based urgent care in any calendar year would still be required. Follow-up care provided by a VA-authorized primary care provider would be exempt from copays. Members of federally recognized tribes are already exempt from copays at Indian Health Service clinics.

Eligibility may be based in part on documentation issued by AI/AN tribal governments to show tribal membership. The VA has proposed the documentation requirement “as this recognizes tribal sovereignty and promotes the Nation-to-Nation relationship that exists between the United States and tribal governments.” The requirement, the notice says, is consistent with the preferences of tribal leaders.

The regulation implements a requirement in the Johnny Isakson and David P. Roe, MD, Veterans Health Care and Benefits Improvement Act of 2020, which prohibited the VA from collecting copayments from AI/AN veterans for hospital care or medical services. Senator Jon Tester (D-MT), chair of the Senate Veterans’ Affairs Committee, and Senator Jerry Moran (R-KS) introduced legislation in 2020 to enact the new policy in January 2022 , which is why the rule is retroactive.

Congress passed the measure as part of a package of veterans’ legislation at the end of 2020, and then-President Donald Trump signed it into law in January 2021. Trueblood said the nature of the federal rulemaking process makes it hard to say exactly when the change will take effect, but that no veteran will be turned away from VA care for not making a copayment, even before the rule is finalized. The VA plans to reimburse eligible veterans who received care in the past year for copayment costs.

“I’m encouraged to see VA answering my call to implement the law and remove burdensome copayments for Native veterans accessing their earned health care,” said Tester in a press release. “The fact is Native veterans have bravely answered the call to duty for generations. And I’ll continue to hold VA accountable in delivering these veterans their long-overdue support.”

New VA rule proposes to eliminate many copays for Native American veteran.

The US Department of Veterans Affairs (VA) has proposed a new rule that would waive medical copayments incurred on or after January 5, 2022, for eligible American Indian and Alaska Native (AI/AN) veterans.

The policy is intended to encourage veterans to seek regular primary care treatment, the VA says. “It’s no mystery to a lot of people that health care is sometimes hard to come by in many Native American communities,” Travis Trueblood, director of the VA Office of Tribal Health, told reporters in January. “So, this effort by VA will enhance getting people into the facilities, helping them feel welcome and getting them to use those benefits that they've earned.”

Copayments for more than 3 visits to community-based urgent care in any calendar year would still be required. Follow-up care provided by a VA-authorized primary care provider would be exempt from copays. Members of federally recognized tribes are already exempt from copays at Indian Health Service clinics.

Eligibility may be based in part on documentation issued by AI/AN tribal governments to show tribal membership. The VA has proposed the documentation requirement “as this recognizes tribal sovereignty and promotes the Nation-to-Nation relationship that exists between the United States and tribal governments.” The requirement, the notice says, is consistent with the preferences of tribal leaders.

The regulation implements a requirement in the Johnny Isakson and David P. Roe, MD, Veterans Health Care and Benefits Improvement Act of 2020, which prohibited the VA from collecting copayments from AI/AN veterans for hospital care or medical services. Senator Jon Tester (D-MT), chair of the Senate Veterans’ Affairs Committee, and Senator Jerry Moran (R-KS) introduced legislation in 2020 to enact the new policy in January 2022 , which is why the rule is retroactive.

Congress passed the measure as part of a package of veterans’ legislation at the end of 2020, and then-President Donald Trump signed it into law in January 2021. Trueblood said the nature of the federal rulemaking process makes it hard to say exactly when the change will take effect, but that no veteran will be turned away from VA care for not making a copayment, even before the rule is finalized. The VA plans to reimburse eligible veterans who received care in the past year for copayment costs.

“I’m encouraged to see VA answering my call to implement the law and remove burdensome copayments for Native veterans accessing their earned health care,” said Tester in a press release. “The fact is Native veterans have bravely answered the call to duty for generations. And I’ll continue to hold VA accountable in delivering these veterans their long-overdue support.”

Physicians nationwide will be challenged by the “unwinding” of the federal public health emergency declared for the COVID-19 pandemic.

The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.

A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.

The result is a patchwork of emergency COVID-19 measures with different end dates.

The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.

Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.

The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”

The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
 

Patients’ questions

Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).

“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”

Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.

For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.

The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.

“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.

States significantly changed Medicaid policy to expand access to care during the pandemic.

All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.

The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.

In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
 

The end of free COVID vaccines, testing for some patients

The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.

After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.

But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).

People who don’t have insurance may lose access to COVID testing and vaccines.

“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
 

Future FDA actions

Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.

But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.

The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.

The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.

The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.

“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.

Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.

“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”

A version of this article first appeared on Medscape.com.

Physicians nationwide will be challenged by the “unwinding” of the federal public health emergency declared for the COVID-19 pandemic.

The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.

A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.

The result is a patchwork of emergency COVID-19 measures with different end dates.

The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.

Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.

The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”

The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
 

Patients’ questions

Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).

“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”

Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.

For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.

The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.

“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.

States significantly changed Medicaid policy to expand access to care during the pandemic.

All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.

The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.

In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
 

The end of free COVID vaccines, testing for some patients

The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.

After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.

But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).

People who don’t have insurance may lose access to COVID testing and vaccines.

“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
 

Future FDA actions

Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.

But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.

The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.

The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.

The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.

“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.

Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.

“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”

A version of this article first appeared on Medscape.com.

Physicians nationwide will be challenged by the “unwinding” of the federal public health emergency declared for the COVID-19 pandemic.

The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.

A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.

The result is a patchwork of emergency COVID-19 measures with different end dates.

The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.

Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.

The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”

The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
 

Patients’ questions

Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).

“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”

Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.

For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.

The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.

“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.

States significantly changed Medicaid policy to expand access to care during the pandemic.

All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.

The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.

In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
 

The end of free COVID vaccines, testing for some patients

The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.

After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.

But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).

People who don’t have insurance may lose access to COVID testing and vaccines.

“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
 

Future FDA actions

Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.

But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.

The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.

The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.

The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.

“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.

Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.

“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”

A version of this article first appeared on Medscape.com.

In 2016, when Erin Schanning lost her brother Ethan to an overdose, she wanted to know what could have been done to have helped him. Ethan, who had struggled with opioids since getting a prescription for the drugs after a dental procedure in middle school, had tried dozens of treatments. But at the age of 30, he was gone.

“After my brother died, I started researching and was surprised to learn that there were many evidence-based ways to treat substance use disorder that he hadn’t had access to, even though he had doggedly pursued treatment,” Ms. Schanning told me in an interview. One of those treatments, buprenorphine, is one of the most effective tools that health care providers have to treat opioid use disorder. A partial opioid agonist, it reduces cravings and prevents overdose, decreasing mortality more effectively than almost any medication for any disease. Yet most providers have never prescribed it.

That may be about to change. Thanks largely to advocates such as Ms. Schanning, who founded End Substance Use Disorder after she lost her brother, Congress has finally removed barriers to prescribing buprenorphine. The special license to prescribe the medication, commonly known as the “X-waiver,” was officially eliminated as part of the passage of the Mainstreaming Addiction Treatment (MAT) Act. Immediately, following the passage of the Act, any provider with a DEA license became eligible to prescribe buprenorphine to treat opioid use disorder, and limits on the number of patients they could treat were eliminated.

Previously, buprenorphine, which has a better safety profile than almost any other prescription opioid because of its ceiling effect on respiratory depression,nonetheless required providers to obtain a special license to prescribe it, and – prior to an executive order from the Biden administration – 8 to 24 hours of training to do so. This led to a misconception that buprenorphine was dangerous, and created barriers for treatment during the worst overdose crisis in our country’s history. More than 110,00 overdose deaths occurred in 2021, representing a 468% increase in the last 2 decades.

Along with the MAT Act, the Medication Access and Training Expansion Act was passed in the same spending bill, requiring all prescribers who obtain a DEA license to do 8 hours of training on the treatment of substance use disorders. According to the Act, addiction specialty societies will have a role in creating trainings. Medical schools and residencies will also be able to fulfill this requirement with a “comprehensive” curriculum that covers all approved medications for the treatment of substance use disorders.

The DEA has not yet confirmed what training will be accepted, according to the Chief Medical Officer of the Substance Abuse and Mental Health Services Administration, Neeraj Gandotra, MD, who spoke to me in an interview. However, it is required to do so by April 5, 2023. Dr. Gandotra also emphasized that state and local laws, as well as insurance requirements, remain in place, and may place other constraints on prescribing. According to the Act, this new rule will be in effect by June 2023.

As an addiction medicine specialist and longtime buprenorphine prescriber, I am excited about these changes but wary of lingering resistance among health care providers. Will providers who have chosen not to get an X-waiver now look for another reason to not treat patients with substance use disorders?

Ms. Schanning remains hopeful. “I’m incredibly optimistic that health care providers are going to learn about buprenorphine and prescribe it to patients, and that patients are going to start asking about this medication,” she told me. “Seven in 10 providers say that they do feel an obligation to treat their patients with [opioid use disorder], but the federal government has made it very difficult to do so.”

Now with the X-waiver gone, providers and patients may be able to push for a long overdue shift in how we treat and conceptualize substance use disorders, she noted.

“Health care providers need to recognize substance use disorder as a medical condition that deserves treatment, and to speak about it like a medical condition,” Ms. Schanning said, by, for instance, moving away from using words such as “abuse” and “clean” and, instead, talking about treatable substance use disorders that can improve with evidence-based care, such as buprenorphine and methadone. “We also need to share stories of success and hope with people,” she added. “Once you’ve seen how someone can be transformed by treatment, it’s really difficult to say that substance use disorder is a character flaw, or their fault.”
 

A patient-centered approach

Over the past decade of practicing medicine, I have experienced this transformation personally. In residency, I believed that people had to be ready for help, to stop using, to change. I failed to recognize that many of those same people were asking me for help, and I wasn’t offering what they needed. The person who had to change was me.

As I moved toward a patient-centered approach, lowering barriers to starting and remaining in treatment, and collaborating with teams that could meet people wherever they might be, addictions became the most rewarding part of my practice.

I have never had more people thank me spontaneously and deeply for the care I provide. Plus, I have never seen a more profound change in the students I work with than when they witness someone with a substance use disorder offered treatment that works.

The X-waiver was not the only barrier to care, and the overdose crisis is not slowing down. But maybe with a new tool widely accessible, more of us will be ready to help.
 

Dr. Poorman is board certified in internal medicine and addiction medicine, assistant professor of medicine, University of Illinois at Chicago, and provides primary care and addiction services in Chicago. Her views do not necessarily reflect the views of her employer. She has reported no relevant disclosures, and she serves on the editorial advisory board of Internal Medicine News.

In 2016, when Erin Schanning lost her brother Ethan to an overdose, she wanted to know what could have been done to have helped him. Ethan, who had struggled with opioids since getting a prescription for the drugs after a dental procedure in middle school, had tried dozens of treatments. But at the age of 30, he was gone.

“After my brother died, I started researching and was surprised to learn that there were many evidence-based ways to treat substance use disorder that he hadn’t had access to, even though he had doggedly pursued treatment,” Ms. Schanning told me in an interview. One of those treatments, buprenorphine, is one of the most effective tools that health care providers have to treat opioid use disorder. A partial opioid agonist, it reduces cravings and prevents overdose, decreasing mortality more effectively than almost any medication for any disease. Yet most providers have never prescribed it.

That may be about to change. Thanks largely to advocates such as Ms. Schanning, who founded End Substance Use Disorder after she lost her brother, Congress has finally removed barriers to prescribing buprenorphine. The special license to prescribe the medication, commonly known as the “X-waiver,” was officially eliminated as part of the passage of the Mainstreaming Addiction Treatment (MAT) Act. Immediately, following the passage of the Act, any provider with a DEA license became eligible to prescribe buprenorphine to treat opioid use disorder, and limits on the number of patients they could treat were eliminated.

Previously, buprenorphine, which has a better safety profile than almost any other prescription opioid because of its ceiling effect on respiratory depression,nonetheless required providers to obtain a special license to prescribe it, and – prior to an executive order from the Biden administration – 8 to 24 hours of training to do so. This led to a misconception that buprenorphine was dangerous, and created barriers for treatment during the worst overdose crisis in our country’s history. More than 110,00 overdose deaths occurred in 2021, representing a 468% increase in the last 2 decades.

Along with the MAT Act, the Medication Access and Training Expansion Act was passed in the same spending bill, requiring all prescribers who obtain a DEA license to do 8 hours of training on the treatment of substance use disorders. According to the Act, addiction specialty societies will have a role in creating trainings. Medical schools and residencies will also be able to fulfill this requirement with a “comprehensive” curriculum that covers all approved medications for the treatment of substance use disorders.

The DEA has not yet confirmed what training will be accepted, according to the Chief Medical Officer of the Substance Abuse and Mental Health Services Administration, Neeraj Gandotra, MD, who spoke to me in an interview. However, it is required to do so by April 5, 2023. Dr. Gandotra also emphasized that state and local laws, as well as insurance requirements, remain in place, and may place other constraints on prescribing. According to the Act, this new rule will be in effect by June 2023.

As an addiction medicine specialist and longtime buprenorphine prescriber, I am excited about these changes but wary of lingering resistance among health care providers. Will providers who have chosen not to get an X-waiver now look for another reason to not treat patients with substance use disorders?

Ms. Schanning remains hopeful. “I’m incredibly optimistic that health care providers are going to learn about buprenorphine and prescribe it to patients, and that patients are going to start asking about this medication,” she told me. “Seven in 10 providers say that they do feel an obligation to treat their patients with [opioid use disorder], but the federal government has made it very difficult to do so.”

Now with the X-waiver gone, providers and patients may be able to push for a long overdue shift in how we treat and conceptualize substance use disorders, she noted.

“Health care providers need to recognize substance use disorder as a medical condition that deserves treatment, and to speak about it like a medical condition,” Ms. Schanning said, by, for instance, moving away from using words such as “abuse” and “clean” and, instead, talking about treatable substance use disorders that can improve with evidence-based care, such as buprenorphine and methadone. “We also need to share stories of success and hope with people,” she added. “Once you’ve seen how someone can be transformed by treatment, it’s really difficult to say that substance use disorder is a character flaw, or their fault.”
 

A patient-centered approach

Over the past decade of practicing medicine, I have experienced this transformation personally. In residency, I believed that people had to be ready for help, to stop using, to change. I failed to recognize that many of those same people were asking me for help, and I wasn’t offering what they needed. The person who had to change was me.

As I moved toward a patient-centered approach, lowering barriers to starting and remaining in treatment, and collaborating with teams that could meet people wherever they might be, addictions became the most rewarding part of my practice.

I have never had more people thank me spontaneously and deeply for the care I provide. Plus, I have never seen a more profound change in the students I work with than when they witness someone with a substance use disorder offered treatment that works.

The X-waiver was not the only barrier to care, and the overdose crisis is not slowing down. But maybe with a new tool widely accessible, more of us will be ready to help.
 

Dr. Poorman is board certified in internal medicine and addiction medicine, assistant professor of medicine, University of Illinois at Chicago, and provides primary care and addiction services in Chicago. Her views do not necessarily reflect the views of her employer. She has reported no relevant disclosures, and she serves on the editorial advisory board of Internal Medicine News.

In 2016, when Erin Schanning lost her brother Ethan to an overdose, she wanted to know what could have been done to have helped him. Ethan, who had struggled with opioids since getting a prescription for the drugs after a dental procedure in middle school, had tried dozens of treatments. But at the age of 30, he was gone.

“After my brother died, I started researching and was surprised to learn that there were many evidence-based ways to treat substance use disorder that he hadn’t had access to, even though he had doggedly pursued treatment,” Ms. Schanning told me in an interview. One of those treatments, buprenorphine, is one of the most effective tools that health care providers have to treat opioid use disorder. A partial opioid agonist, it reduces cravings and prevents overdose, decreasing mortality more effectively than almost any medication for any disease. Yet most providers have never prescribed it.

That may be about to change. Thanks largely to advocates such as Ms. Schanning, who founded End Substance Use Disorder after she lost her brother, Congress has finally removed barriers to prescribing buprenorphine. The special license to prescribe the medication, commonly known as the “X-waiver,” was officially eliminated as part of the passage of the Mainstreaming Addiction Treatment (MAT) Act. Immediately, following the passage of the Act, any provider with a DEA license became eligible to prescribe buprenorphine to treat opioid use disorder, and limits on the number of patients they could treat were eliminated.

Previously, buprenorphine, which has a better safety profile than almost any other prescription opioid because of its ceiling effect on respiratory depression,nonetheless required providers to obtain a special license to prescribe it, and – prior to an executive order from the Biden administration – 8 to 24 hours of training to do so. This led to a misconception that buprenorphine was dangerous, and created barriers for treatment during the worst overdose crisis in our country’s history. More than 110,00 overdose deaths occurred in 2021, representing a 468% increase in the last 2 decades.

Along with the MAT Act, the Medication Access and Training Expansion Act was passed in the same spending bill, requiring all prescribers who obtain a DEA license to do 8 hours of training on the treatment of substance use disorders. According to the Act, addiction specialty societies will have a role in creating trainings. Medical schools and residencies will also be able to fulfill this requirement with a “comprehensive” curriculum that covers all approved medications for the treatment of substance use disorders.

The DEA has not yet confirmed what training will be accepted, according to the Chief Medical Officer of the Substance Abuse and Mental Health Services Administration, Neeraj Gandotra, MD, who spoke to me in an interview. However, it is required to do so by April 5, 2023. Dr. Gandotra also emphasized that state and local laws, as well as insurance requirements, remain in place, and may place other constraints on prescribing. According to the Act, this new rule will be in effect by June 2023.

As an addiction medicine specialist and longtime buprenorphine prescriber, I am excited about these changes but wary of lingering resistance among health care providers. Will providers who have chosen not to get an X-waiver now look for another reason to not treat patients with substance use disorders?

Ms. Schanning remains hopeful. “I’m incredibly optimistic that health care providers are going to learn about buprenorphine and prescribe it to patients, and that patients are going to start asking about this medication,” she told me. “Seven in 10 providers say that they do feel an obligation to treat their patients with [opioid use disorder], but the federal government has made it very difficult to do so.”

Now with the X-waiver gone, providers and patients may be able to push for a long overdue shift in how we treat and conceptualize substance use disorders, she noted.

“Health care providers need to recognize substance use disorder as a medical condition that deserves treatment, and to speak about it like a medical condition,” Ms. Schanning said, by, for instance, moving away from using words such as “abuse” and “clean” and, instead, talking about treatable substance use disorders that can improve with evidence-based care, such as buprenorphine and methadone. “We also need to share stories of success and hope with people,” she added. “Once you’ve seen how someone can be transformed by treatment, it’s really difficult to say that substance use disorder is a character flaw, or their fault.”
 

A patient-centered approach

Over the past decade of practicing medicine, I have experienced this transformation personally. In residency, I believed that people had to be ready for help, to stop using, to change. I failed to recognize that many of those same people were asking me for help, and I wasn’t offering what they needed. The person who had to change was me.

As I moved toward a patient-centered approach, lowering barriers to starting and remaining in treatment, and collaborating with teams that could meet people wherever they might be, addictions became the most rewarding part of my practice.

I have never had more people thank me spontaneously and deeply for the care I provide. Plus, I have never seen a more profound change in the students I work with than when they witness someone with a substance use disorder offered treatment that works.

The X-waiver was not the only barrier to care, and the overdose crisis is not slowing down. But maybe with a new tool widely accessible, more of us will be ready to help.
 

Dr. Poorman is board certified in internal medicine and addiction medicine, assistant professor of medicine, University of Illinois at Chicago, and provides primary care and addiction services in Chicago. Her views do not necessarily reflect the views of her employer. She has reported no relevant disclosures, and she serves on the editorial advisory board of Internal Medicine News.