Abstract
Objectives
To assess whether using coronavirus disease 2019 (COVID-19) community activity level can accurately inform strategies for routine testing of facility staff for active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Design
Cross-sectional study.
Setting and Participants
In total, 59,930 nursing home staff tested for active SARS-CoV-2 infection in Indiana.
Measures
Receiver operator characteristic curves and the area under the curve to compare the sensitivity and specificity of identifying positive cases of staff within facilities based on community COVID-19 activity level including county positivity rate and county cases per 10,000.
Results
The detection of any infected staff within a facility using county cases per 10,000 population or county positivity rate resulted in an area under the curve of 0.648 (95% confidence interval 0.601‒0.696) and 0.649 (95% confidence interval 0.601‒0.696), respectively. Of staff tested, 28.0% were certified nursing assistants, yet accounted for 36.9% of all staff testing positive. Similarly, licensed practical nurses were 1.4% of staff, but 4.7% of positive cases.
Conclusions and Implications
We failed to observe a meaningful threshold of community COVID-19 activity for the purpose of predicting nursing homes with any positive staff. Guidance issued by the Centers for Medicare and Medicaid Services in August 2020 sets the minimum frequency of routine testing for nursing home staff based on county positivity rates. Using the recommended 5% county positivity rate to require weekly testing may miss asymptomatic infections among nursing home staff. Further data on results of all-staff testing efforts, particularly with the implementation of new widespread strategies such as point-of-care testing, is needed to guide policy to protect high-risk nursing home residents and staff. If the goal is to identify all asymptomatic SARS-Cov-2 infected nursing home staff, comprehensive repeat testing may be needed regardless of community level activity.
Keywords
Nursing home residents have been disproportionately affected by the coronavirus 2019 (COVID-19) pandemic. In the United States 33%‒82% of COVID-19 deaths are residents of long-term care facilities, a proportion similar to Canada and across Europe.
1
,- Comas-Herrera A.
- Zalakaí J.
- Litwin C.
- et al.
Mortality associated with COVID-19 outbreaks in care homes: Early international evidence. International Long-Term Care Policy Network [Internet].
https://ltccovid.org/wp-content/uploads/2020/05/Mortality-associated-with-COVID-3-May-final-5.pdf
Date accessed: August 11, 2020
2
Underlying conditions, including type 2 diabetes mellitus, serious heart conditions, and chronic kidney disease, make residents at high risk for complications of infection from severe acute respiratory coronavirus 2 (SARS-CoV-2).- Tolbert J.
- Hall C.
- Orgera K.
- et al.
State data and policy actions to address coronavirus [Internet]. San Francisco (CA): Henry J. Kaiser Family Foundation.
https://www.kff.org/health-costs/issue-brief/state-data-and-policy-actions-to-address-coronavirus/
Date accessed: October 1, 2020
3
,Centers for Disease Control and Prevention
Coronavirus Disease 2019 (COVID-19) [Internet]. Washington (DC): HHS.
Coronavirus Disease 2019 (COVID-19) [Internet]. Washington (DC): HHS.
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
Date accessed: August 11, 2020
4
Until recently, facilities had largely shut down visitation and only allowed essential staff, who are screened for SARS-CoV-2 symptoms, to enter and provide care for residents and monitor their health status.Centers for Medicare and Medicaid Services
Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes [Internet]. Baltimore (MD): HHS.
Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes [Internet]. Baltimore (MD): HHS.
https://www.cms.gov/files/document/3-13-2020-nursing-home-guidance-covid-19.pdf
Date accessed: August 11, 2020
4
Despite these measures, 50,000‒80,000 deaths have occurred in long-term care facilities as of October 1, 2020.Centers for Medicare and Medicaid Services
Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes [Internet]. Baltimore (MD): HHS.
Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes [Internet]. Baltimore (MD): HHS.
https://www.cms.gov/files/document/3-13-2020-nursing-home-guidance-covid-19.pdf
Date accessed: August 11, 2020
2
,- Tolbert J.
- Hall C.
- Orgera K.
- et al.
State data and policy actions to address coronavirus [Internet]. San Francisco (CA): Henry J. Kaiser Family Foundation.
https://www.kff.org/health-costs/issue-brief/state-data-and-policy-actions-to-address-coronavirus/
Date accessed: October 1, 2020
5
As cases continue to rise, surveillance of infected staff is paramount to protecting nursing home residents.Centers for Medicare and Medicaid Services
COVID-19 Nursing Home Data. [Internet]. Baltimore (MD): HHS.
COVID-19 Nursing Home Data. [Internet]. Baltimore (MD): HHS.
https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/
Date accessed: October 1, 2020
Asymptomatic transmission of SARS-CoV-2 by staff, followed by rapid spread, is believed to be the major contributing factor to outbreaks in nursing homes.
6
,7
On May 18, 2020, Centers for Medicare and Medicaid Services (CMS) first recommended weekly testing of all nursing home staff, but advised that local and state governments could adjust this frequency according to local factors.8
Resource limitations including testing supply shortages (eg, swabs, reagents), costs, reporting delays, and logistical issues have challenged states and facilities to develop and implement comprehensive weekly testing programs.Centers for Medicare and Medicaid Services
Nursing Home Reopening Recommendations for State and Local Officials [Internet]. Baltimore (MD): HHS.
Nursing Home Reopening Recommendations for State and Local Officials [Internet]. Baltimore (MD): HHS.
https://www.cms.gov/files/document/qso-20-30-nh.pdf
Date accessed: August 11, 2020
9
, 10
, 11
CMS has begun to distribute 15,000 point-of-care testing machines, along with an initial supply of testing materials, to every nursing home in the United States.- Kukka C.
To Curb COVID-19 Nursing Home Deaths, States Design their Own Testing Strategies [Internet]. Washington (DC): The National Academy for State Health Policy.
https://www.nashp.org/to-curb-covid-19-nursing-home-deaths-states-design-their-own-testing-strategies/
Date accessed: May 25, 2020
12
Testing capacity is also being supplemented by the distribution of Abbott BinaxNOW point-of-care antigen test cards by the Department of Health and Human Services.13
New guidance issued by CMS on August 26, 2020 has set the minimum frequency of routine staff testing based on community COVID-19 activity: <5% monthly, 5% to 10% weekly, >10% twice weekly.Indiana Department of Health
Long Term Care Newsletter: Abbott BinaxNOW Test – Distribution to Nursing Homes and Assisted Living Facilities. September 17, 2020. Issue 2020-60.
Long Term Care Newsletter: Abbott BinaxNOW Test – Distribution to Nursing Homes and Assisted Living Facilities. September 17, 2020. Issue 2020-60.
https://www.in.gov/isdh/files/IDH%20Long%20Term%20Care%20Newsletter%20Issue%202020-60.pdf
Date accessed: October 10, 2020
14
Noncompliance with testing frequency as recommended will result in citations and financial consequences.Centers for Medicare and Medicaid Services
Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool [Internet]. Baltimore (MD): HHS.
Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool [Internet]. Baltimore (MD): HHS.
https://www.cms.gov/files/document/qso-20-38-nh.pdf
Date accessed: August 28, 2020
14
A new SARS-CoV-2 infection in any staff member is considered an outbreak by CMSCenters for Medicare and Medicaid Services
Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool [Internet]. Baltimore (MD): HHS.
Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool [Internet]. Baltimore (MD): HHS.
https://www.cms.gov/files/document/qso-20-38-nh.pdf
Date accessed: August 28, 2020
15
; relying on community COVID-19 activity level remains an untested strategy to identify any facility with at least 1 infected staff member.Centers for Disease Control and Prevention
Testing Guidelines for Nursing Homes: Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel [Internet]. Washington (DC): HHS.
Testing Guidelines for Nursing Homes: Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel [Internet]. Washington (DC): HHS.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-testing.html#nursing-home
Date accessed: August 28, 2020
Methods
The Indiana Department of Health (IDH) aimed to test all Indiana nursing home staff in the month of June, 2020. Consistent with the CMS definition, staff included employees, consultants, contractors, volunteers, or other individuals regularly providing care within and on behalf of the facility. Nursing homes acquired samples from staff using test kits provided by IDH, or requested on-site sampling. All samples were taken using nasopharyngeal swabs for a polymerase chain reaction (PCR)-based test by a laboratory contracted with the IDH. Facilities could also report results from PCR-based testing done elsewhere. Staff with a documented prior positive PCR test were exempted. Employee demographic information, role, facility name (only1 could be chosen), test date, any close contact with a person infected with SARS-CoV-2, and current symptoms were collected during registration for those tested onsite with IDH test kits. Individuals with inconclusive results were retested. Staff with multiple tests were identified by matching name (first and last) and date of birth, and only the most recent test was included.
Employee data were aggregated to the facility-level. Facility-level measures were calculated to represent the total number of staff tested and the total that tested positive. Facility location was linked with county COVID-19 activity level, for the month of June, as was displayed on the IDH public dashboard. This included the number of reported cases, number of tests performed, and number of positive tests. County population estimates were extracted from the 2019 American Communities Survey.
Characteristics of staff overall and by those positive are presented. Facilities were categorized based on whether they had any positive staff or 3 or more positive staff, which was considered as higher risk of infection to residents. The sensitivity and specificity of both these outcomes were calculated for each observed level of county test positivity rate (0.31%‒25.08%) and cases per 10,000 population (11‒951). Receiver operator characteristic curves were plotted and the area under the curve (AUC) was estimated using the trapezoidal rule.
Results
Of 44,065 staff with complete test results (73% of all nursing home staff), 1% (n = 466) were positive for active SARS-CoV-2 infection and 177 facilities (32.5%) had at least 1 positive staff member. Of staff tested, 35,685 were done so onsite (81.0%) and 8380 (19.0%) results were confirmed by facilities through outside laboratories. Data were missing for 23.3% of staff statewide because of missing data or inconclusive results (Supplementary Figure 1). In addition, some staff were tested prior to June and exempted (1.8%) or were documented as refusing testing (1.3%).
The detection of any positive cases within a facility using county cases per 10,000 population or county positivity rate resulted in an AUC of 0.648 [95% confidence interval (CI) 0.601‒0.696] and 0.649 (95% CI 0.601‒0.696), respectively (Figure 1). The AUC values for detecting facilities with 3 or more positive staff were 0.682 (95% CI 0.612‒0.753) for county cases per 10,000 population and 0.691 (0.622‒0.760) for county positivity rate.
Fig. 1Receiver operator characteristic curves (ROC) representing community COVID-19 activity levels to guide nursing home staff testing in Indiana. (A) ROC curve for detecting any positive staff using county cases per 10,000. (B) ROC curve for identifying 3 or more positive staff using county cases per 10,000. (C) ROC curve for identifying any positive staff using county positivity rate. (D) ROC curve for identifying 3 or more positive staff using county positivity rate. Source: Authors' calculations based upon IDH data from staff tested for SARS-CoV-2 during the month of June 2020 and county-reported cases and percent of positive tests. Indiana county population data were obtained from the American Communities Survey for 2019 (1-year estimate). Data represent 44,065 nursing home staff in 544 facilities statewide.
Certified nursing assistants were 28.0% of staff tested, yet accounted for 36.9% of all staff testing positive (Table 1). Similarly, licensed practical nurses represented 1.4% of staff tested, but 4.7% of positive cases. Of staff tested onsite, 11.6% reported close contact with a SARS-CoV-2 infected person, including 39.1% who tested positive.
Table 1Characteristics of Nursing Home Staff Tested for SARS-CoV-2 Infection in Indiana During June 2020, Overall and by Those Testing Positive for Active Infection
| Number of Staff with Recorded Results, % | Number with Positive Test Recorded in June, % | |||
|---|---|---|---|---|
| n | % | n | % | |
| Total | 44,065 | 73 | 466 | 1.1 |
| Age category, y | ||||
| 15‒25 | 8776 | 19.9 | 113 | 24.2 |
| 26‒35 | 9200 | 20.9 | 93 | 20.0 |
| 36‒45 | 9198 | 20.9 | 91 | 19.5 |
| 46‒55 | 8544 | 19.4 | 87 | 18.7 |
| 56‒65 | 6641 | 15.1 | 62 | 13.3 |
| 66‒75 | 1493 | 8.4 | 13 | 2.8 |
| 76+ | 165 | 0.4 | X | X |
| Unknown | 48 | 0.1 | X | X |
| Race | ||||
| White | 25,258 | 57.3 | 148 | 31.8 |
| Black or African American | 5914 | 13.4 | 71 | 15.2 |
| Asian | 589 | 1.3 | X | X |
| Multiracial | 601 | 1.4 | X | X |
| Other | 891 | 2.0 | 11 | 2.4 |
| Unknown | 10,763 | 24.4 | 225 | 48.3 |
| Hispanic | 1187 | 2.7 | 16 | 3.4 |
| Unknown ethnicity | 12,696 | 28.8 | 237 | 50.9 |
| Role | ||||
| Activities | 1545 | 3.5 | X | X |
| Administration | 1825 | 4.1 | X | X |
| Certified nursing assistant | 12,332 | 28.0 | 172 | 36.9 |
| Dietary | 5251 | 11.9 | 39 | 8.4 |
| Physician | 82 | 0.2 | 0 | 0 |
| Nurse practitioner/physician assistant | 84 | 0.2 | X | X |
| Housekeeping | 3503 | 7.9 | 21 | 4.5 |
| Licensed practical nurse | 637 | 1.4 | 22 | 4.7 |
| Other | 3473 | 7.9 | 27 | 5.8 |
| Registered nurse (administrative) | 1610 | 3.7 | 15 | 3.2 |
| Registered nurse (patient care) | 5760 | 13.1 | 48 | 10.3 |
| Social services | 545 | 1.2 | X | X |
| Therapy (physical, occupational, speech) | 2389 | 5.4 | 22 | 4.7 |
| Role not recorded | 5029 | 11.4 | 81 | 17.4 |
| Contact with SARS-CoV-2 infected person | ||||
| Yes | 4154 | 11.5 | 97 | 39.1 |
| No | 31,493 | 88.3 | 151 | 60.9 |
| Use of tobacco or e-cigarettes | ||||
| Some days | 2256 | 6.3 | 26 | 10.5 |
| Every day | 7662 | 21.5 | 28 | 11.3 |
Source: Authors' calculations based upon IDH data from staff tested for SARS-CoV-2 during the month of June 2020 and county-reported cases and percent of positive tests. Indiana county population data were obtained from the American Communities Survey for 2019 (1-year estimate).
Cell counts denoted with an “X” are suppressed due small samples (<10) and privacy concerns.
∗ Questions were asked of n = 36,685 staff tested on-site, including n = 248 with a positive test; this information was not collected for staff members with confirmed PCR-based test results from outside laboratories.
Of 544 facilities, 177 (32.5%) had at least 1 staff member test positive and 47 (8.6%) had 3 or more (Table 2). Facilities in counties in the highest quartile of community positivity represented 17.8% of all facilities yet 27.1% of facilities with a positive staff member, and 31.9% of those with 3 or more positive staff. Similarly, facilities in counties with the greatest number of cases per 10,000 population represented 20.6% of all facilities, yet accounted for 30.5% of facilities with a positive staff member; and 36.2% of facilities with 3 or more positive staff members.
Table 2Number of Staff and Measures of Community Spread of SARS-CoV-2 for Nursing Home Facilities in Indiana During June 2020
| Number of Facilities, % | Number of Facilities with Any Positive, % | Number of Facilities with 3+ Positive, % | ||||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
| Total | 544 | 100 | 177 | 32.5 | 47 | 8.6 |
| Number of facility staff (quartiles) | ||||||
| 76 or fewer | 147 | 27.0 | 27 | 15.3 | 3 | 6.4 |
| 77‒102 | 133 | 24.4 | 35 | 19.8 | 7 | 14.9 |
| 103‒140 | 142 | 26.1 | 49 | 27.7 | 15 | 31.9 |
| 140 or more | 122 | 22.4 | 66 | 37.3 | 22 | 46.8 |
| County positivity rate (quartiles) | ||||||
| 2.33% or less | 138 | 25.6 | 31 | 17.5 | 3 | 6.4 |
| 2.34%‒3.64% | 135 | 25.0 | 34 | 19.2 | 8 | 17.0 |
| 3.65% ‒5.33% | 172 | 31.9 | 63 | 35.6 | 21 | 44.7 |
| 5.34% or higher | 95 | 17.8 | 48 | 27.1 | 15 | 31.9 |
| County cases per 10,000 population (quartiles) | ||||||
| 74 or lower | 139 | 25.6 | 30 | 16.9 | 6 | 12.8 |
| 75‒113 | 134 | 25.0 | 33 | 18.6 | 4 | 8.5 |
| 114‒171 | 156 | 28.9 | 59 | 33.3 | 20 | 42.6 |
| 172 or higher | 111 | 20.6 | 54 | 30.5 | 17 | 36.2 |
Source: Authors' calculations based upon IDH data from staff tested for SARS-CoV-2 during the month of June 2020 and county-reported cases and percent of positive tests. Indiana county population data were obtained from the American Communities Survey for 2019 (1-year estimate).
Discussion
If the goal of the CMS testing strategy is to identify all asymptomatic SARS-Cov-2 infected nursing home staff,
14
,Centers for Medicare and Medicaid Services
Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool [Internet]. Baltimore (MD): HHS.
Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID-19 Focused Survey Tool [Internet]. Baltimore (MD): HHS.
https://www.cms.gov/files/document/qso-20-38-nh.pdf
Date accessed: August 28, 2020
15
results from Indiana's statewide all-staff testing initiative reveal that some outbreaks may be missed if thresholds are set using community COVID-19 activity. For example, if weekly testing occurred only in facilities within Indiana counties with a positivity rate of 5% or greater, 47.7% of facilities with a positive case would be identified and 21.2% of facilities without a case would be tested. This strategy may miss over one-half of the facilities with a SARS-CoV-2 infected staff member, particularly if asymptomatic. Based on Indiana's data, to capture all facilities with a positive staff (ie, sensitivity of 100%), the testing threshold must be set at 1% county positivity rate; consequently, this would also test 97% of facilities without any positive staff. As evidenced by AUC values near 0.5, the use of community COVID-19 activity was slightly better than chance at distinguishing facilities with positive cases vs none.Centers for Disease Control and Prevention
Testing Guidelines for Nursing Homes: Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel [Internet]. Washington (DC): HHS.
Testing Guidelines for Nursing Homes: Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel [Internet]. Washington (DC): HHS.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-testing.html#nursing-home
Date accessed: August 28, 2020
Other findings from this statewide testing initiative suggest key characteristics of staff and facilities may require additional monitoring. Among certified nursing assistants, infections were nearly 9 percentage points greater than expected based on their proportional make-up and 3 percentage points greater for licensed practical nurses. Both roles provide direct patient care and present higher risk of staff-to-resident or resident-to-staff transmission than other roles. Likewise, facilities with the most staff were overrepresented with positive cases, perhaps because of more potential exposures by staff outside the facility or because these were located in areas with greater transmission. Although its usefulness is limited in guiding testing efforts, per our results, we do observe facilities are more likely to have SARS-CoV-2 infected staff in areas with higher COVID-19 activity. As the nursing home industry, state and federal governments grapple with the logistics and costs of ongoing staff testing, thresholds to determine frequencies needed to identify outbreaks quickly will require continued examination.
Our analyses have limitations that include using cross-sectional data not suited for determining cause-and-effect. Although we used the official state counts for community COVID-19 spread, we recognize that the data systems and reporting procedures are rapidly evolving and could affect our conclusions as data quality improves. Missing information and staff refusal rates may have affected our conclusions, as approximately 21% of the estimated number of staff had missing data. A considerable number of staff were on extended leave due to COVID-19 concerns and likely contributed to this proportion with missing data. This missing data also highlight challenges to facilities in administering and coordinating testing efforts and the lack of any prior infrastructure for facilities to report results for state officials to monitor. Furthermore, per current CMS guidance, nursing homes are required to ensure testing is done not just for employed staff, but consultants and contractors as well. The small numbers of physicians and advance practice providers who were tested during this state-sponsored initiative may reflect additional challenges in coordinating testing or receiving test results from outside laboratories for these providers within narrow timeframes.
Conclusions and Implications
Using the recommended 5% county positivity rate to guide weekly testing of all nursing home staff may miss asymptomatic staff in these facilities. Further data on results of all-staff testing efforts, particularly with the implementation of new widespread strategies such as point-of-care testing, is needed to guide policy to protect high-risk nursing home residents and staff.
Acknowledgments
We acknowledge the contributions of Matt Foster and Brenda Buroker from the Indiana Department of Health and Russ Evans of Probari, Inc.
Supplementary Data
Supplementary Fig. 1Number and Outcome of Indiana Nursing Home Staff Tested for Active SARS-CoV-2 Infection during June 2020. The estimated total staff were reported by each facility prior to the launch of the testing effort to enable the ISDH to plan for testing supplies and sample collection.
References
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Article Info
Publication History
Published online: October 28, 2020
Footnotes
KU is CEO and Founder of Probari, Inc, a program to train nurses to reduce nursing home hospital transfers.
This work was supported by the Indiana Department of Health .
The authors declare no conflicts of interest.
Identification
Copyright
© 2020 AMDA - The Society for Post-Acute and Long-Term Care Medicine.
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