Att D-2 Itemized IC Revisions and Justification

National Healthcare Safety Network (NHSN)

OMB Control No. 0920-0666

Revision Request July 2019

Itemized IC Revisions and Justifications

Form No. in Red **: form changes

Form No. in Green: Change in burden/response

Form No.	Name	Name in last ICR	Itemized Changes	Justifications
57.100	NHSN Registration Form	No change	No change	N/A
57.101	Facility Contact Information	No change	No change	N/A
**57.103	Patient Safety Component-Annual Hospital Survey	No change	The number of respondents increased from 5,000 to 5,175. Modify question #30. Modify Response option #51.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden. Annual facility participation in the Patient Safety Component increased during the 2019 reporting year due to growth in the number of facilities participating in NHSN. Question modified to identify if administering antimicrobials to well-baby newborns was a routine practice in a facility. Additional options added after reviewing free-text responses from previous survey. These changes will increase the annual burden of this form by 219 hours.
**57.104	NHSN Facility Administrator Change Request Form	No change	The number of respondents increased from 0 to 800.	This is a new form that will be completed by facility administrators when changes are made to the users at the facility who may no longer have access to NHSN or no longer employed by the facility. This form will be completed to inform changes that NHSN staff will make within the application. This form is intended to be made electronic by NHSN shortly after it is rolled out. These changes will increase the annual burden of this form by 67 hours.
57.105	Group Contact Information	No change	No change	N/A
57.106	Patient Safety Monthly Reporting Plan	No change	No change	N/A
**57.108	Primary Bloodstream Infection (BSI)	No change	Response options for event-related “Risk Factors” were updated from optional to required. The number of respondents decreased from 6,000 to 5,775. The number of responses per respondent decreased from 44 to 5. Annual time burden for the form increased from 33 to 38 minutes. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	Response options were changed from optional to required after being optional for the first time being introduced to NHSN. Annual facility participation decreased during the 2019 reporting year. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified that, in 2018, 5,500 facilities submitted at least 1 Device-associated Summary Form. We added 5% (275) to 5500 to represent an estimate of events that will need to be reported that were not previously reported due to a data field moving from optional to required. Responses were updated based on the number of events reported by respondents to NHSN. Time burden increased to account for the responses to the form being required instead of optional for complete reporting into NHSN. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 126,913 hours.
**57.111	Pneumonia (PNEU)	No change	The number of responses per respondent decreased from 72 to 30. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN and the overall reduction of burden. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified that we over-estimated the number of responses per respondent in 2018. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 37,800 hours.
**57.112	Ventilator-Associated Event	No change	The number of respondents decreased from 5,615 to 5,463. The number of responses per respondent decreased from 144 to 5. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	Annual facility participation decreased during the 2019 reporting year. As of 10/1/2018 (after reporting deadline of 2/18/2019), CMS no longer requires reporting of Ventilator-Associated Event (VAE) by long-term acute care hospitals (LTACs), so we anticipate that some LTACs will no longer report these events and associated summary data to NHSN. Therefore, an estimate of 25% of LTACs will be removed from the numbers. 609 LTACs are enrolled in NHSN currently. 25% of 609 is 152, which were removed from the numbers. Responses were updated based on the number of events reported by respondents to NHSN in 2018. A total of 25,500 VAEs were reported, which rounds to approx. 5 events per facility. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 364,495 hours.
**57.113	Pediatric Ventilator-Associated Event (PedVAE)	No change	The number of respondents increased from 100 to 334. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	Annual facility participation increased during the 2019 reporting year based on our revised estimation. There are 240 hospitals in PA according to Google, and 220 children’s hospital in the US. All PA hospitals are required by their state to report, and we can estimate that 25% of children’s hospitals will voluntarily report (55). We can estimate that 10% of the 3900 US hospitals enrolled in general hospitals enrolled in NHSN will report (recognizing a few of these will be duplicates from PA hospitals) (39). 240+55+39=334. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will increase the annual burden of this form by 14,040 hours.
**57.114	Urinary Tract Infection (UTI)	No change	The number of respondents decreased from 6,000 to 5,500 The number of responses per respondent decreased from 40 to 5. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified that 5,500 facilities submitted at least 1 Device-associated Summary Form in 2018. Responses were updated based on the number of events reported by respondents to NHSN. Through our new reports, we identified that 25,700 catheter-associated UTIs were reported by 5,500 facilities for average of 5 events (responses)/facility. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 70,833 hours.
**57.115	Custom Event	No Change	Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. This change will not impact the annual burden of this form.
57.116	Denominators for Neonatal Intensive Care Unit (NICU)	No change	The number of respondents decreased from 6,000 to 220. Time burden for this form increased by from 4 hours to 4.15 hours or (240 to 249 minutes).	NHSN has revised the methods used to calculate the annual burden for this form. The number of device-associated summary forms were determined by the number of each form completed of each type divided by the number of facilities completing each type of denominator form. Time burden increased to account for the amount of time it takes for accurate and complete reporting into NHSN. The 15-minute increase is due to the addition of optional reporting for patient days and ventilator days by Gestational Age Categories. These changes will decrease the annual burden of this form by 205,044 hours.
57.117	Denominators for Specialty Care Area (SCA)/Oncology (ONC)	No change	The number of respondents decreased from 2,000 to 500. The number of responses per respondent increased from 9 to 21.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden. The number of device-associated Summary Forms were determined by the number of each form completed of each type divided by the number of facilities completing each type of denominator form. NHSN has decreased the anticipated respondents accordingly, to account for accurate reporting of this form. The number of responses was increased to account for increased annual reporting on this form into NHSN based on data collected from NHSN’s internal reports. These changes will decrease the annual burden of this form by 60,634 hours.
57.118	Denominators for Intensive Care Unit (ICU)/Other Locations (Not NICU or SCA)	No change	The number of respondents decreased from 6,000 to 5,500	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified that annual facility completion of this form is estimated to decrease during the 2019 reporting year. The number of device-associated Summary Forms were determined by the number of each form completed of each type divided by the number of facilities completing each type of denominator form. This change will decrease the annual burden of this form by 151,000 hours.
**57.120	Surgical Site Infection (SSI)	No change	The number of respondents decreased from 6,000 to 4,500 The number of responses per respondent decreased from 36 to 11. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden. NHSN has decreased the anticipated respondents accordingly, to account for accurate reporting of this form. The number of responses was decreased to account for decreased annual reporting on this form into NHSN. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 97,125 hours.
57.121	Denominator for Procedure	No change	The number of respondents decreased from 6,000 to 4,500 The number of responses per respondent increased from 540 to 680	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden. NHSN has decreased the anticipated respondents accordingly, to account for accurate reporting of this form. The number of responses was increased to account for increased annual reporting on this form into NHSN. These changes will decrease the annual burden of this form by 30,000 hours.
57.122	HAI Progress Report State Health Department Survey	N/A
57.123	Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables	No change	Increase the number of annual respondents from 1,000 to 1,500.	Annual facility participation increased during the 2019 reporting year due to outreach and education efforts conducted by CDC, health departments, and various HAI partners to encourage facilities to report AUR data in NHSN. This change will increase the annual burden of this form by 500 hours.
57.124	Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables	No change	No change	N/A
57.125	Central Line Insertion Practices (CLIP) Adherence Monitoring	No change	Increase the number of reporting facilities from 100 to 500. Increase the number of annual responses from 100 to 213.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified that, in 2018, 500 facilities reported an event using this form. This number is expected to be the same for 2019. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. We divided the total number of CLIP events reported (106,700) by 500 facilities reporting them to get 213 responses per facility. These changes will increase the annual burden of this form by 40,208 hours.
**57.126	MDRO or CDI Infection Form	No change	Decrease the number of annual respondents from 6,000 to 720. Decrease the number of annual responses from 72 to 12. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified that, in 2018, there were 8,364 non-LabID MDRO infection events reported from 719 facilities, for an average of 11.6 events per facility-year. Estimates for 2019 were rounded up to 720 facilities, 12 per facility per year. NHSN has decreased the anticipated respondents accordingly, to account for accurate reporting of this form. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 211,680 hours.
**57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	No change	Add MSSA Column to form. Increase the number of respondents from 4,930 to 5,550. The number of responses per respondent increased from 24 to 29.	The revision will make the section more concise and easier to identify by reporting facilities and NHSN users. Currently, each MDRO/CDI organism is listed with a separate column, except MSSA. Adding MSSA as a separate column will improve the accuracy of HAI reporting and allow for MSSA-specific data analysis. Annual facility participation increased during the 2019 reporting year. 5,500 facilities reported at least 1 MDRO/CDI Summary form in 2018. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. 161,200 forms were submitted by a total of 5,500 facilities; 161,200 / 5500 = 29. These changes will increase the annual burden of this form by 10,295 hours.
57.128	Laboratory-identified MDRO or CDI Event	No change	Decrease number of respondents from 4,930 to 4,800. Decrease the number of annual responses from 240 to 87.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden to determine that facility respondents will decrease during the 2019 reporting year. Beginning October 1, 2018 (after reporting deadline of Feb. 18, 2019), CMS discontinued requirements for facilities participating in the Long-term Acute Care Hospital quality reporting program and the Inpatient Rehabilitation Facility quality reporting program to report NHSN Facility-wide Inpatient Hospital-onset Methicillin-resistant Staphylococcus aureus (MRSA) Bacteremia Outcome Measure (NQF #1716). Thus, the number of respondents for this form decreased resulting from these changes by CMS. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. These changes will decrease the annual burden of this form by 255,200 hours.
57.129	Adult Sepsis	No change	No change	N/A
**57.136	Long-Term Care Facility Component – Respiratory Tract Infection	No change	New Optional Form	For 2020, prior to introducing the new module and form to NHSN users, the CDC’s Epidemiology Research & Innovations (ERIB) team will use the form to perform field testing of the form variables to explore the utilization, applicability, and data collection burden associated with these variables. This process will inform areas of improvement prior to incorporating the new module, including protocol, forms, and instructions into NHSN. These changes will increase the annual burden of this form by 2,400 hours.
57.137	Long-Term Care (LTC) Facility Component – Annual Facility Survey	No change	Decrease number of respondents from 2,600 to 2,220.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified an overestimation in 2018. Thus, annual LTC facility response for this form is estimated to decrease during the 2019 reporting year. This change will decrease the annual burden of this form by 760 hours
**57.138	Laboratory-identified MDRO or CDI Event for LTCF	No change	Remove response option for “Social Security Number” Remove response option for “Resident Type.” Decrease the time burden from 20 minutes to 15 minutes. Decrease number of respondents from 2,600 to 2,150. Increase the number of responses per respondent from 12 to 24.	The resident social security number is being removed from all event forms since the information is not required to identify residents. The resident type will be auto-populated by the NHSN application. Time burden for this form will be decreased by 5 minutes. Annual facility participation decreased during the 2019 reporting year. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. These changes will increase the annual burden of this form by 5,100 hours.
57.139	MDRO and CDI LabID Event Reporting Monthly Summary Data for LTCF	No change	Decrease number of respondents from 2,600 to 2,220.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified an overestimation in 2018. Thus, annual LTC facility response for this form is estimated to decrease during the 2019 reporting year. This change will decrease the annual burden of this form by 1,600 hours.
**57.140	Urinary Tract Infection (UTI) for LTCF	No change	Decrease number of respondents from 2,600 to 400. Remove response option for “Social Security Number.” Remove response option for “Resident Type.” Modify answer choices to remove specimen collection type. Decrease the time burden from 35 minutes to 30 minutes per response. Update response options with the newly classified ‘Klebsiella’ organism, in the pathogens and susceptibility section. ‘Klebsiella’ from ‘Enterobacter’.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified an overestimation in 2018. Thus, annual LTC facility response for this form is estimated to decrease during the 2019 reporting year. The resident social security number is being removed from all event forms since the information is not required to identify residents. The resident type will be auto-populated by the NHSN application. Specimen collection method removed from the form and only one urine culture laboratory selection available since UTI criteria are the same for all specimen collection methods. Time burden for this form will be decreased by 5 minutes. Add the ‘Klebsiella’ organism the pathogens and susceptibility section. This change to the pathogens and susceptibility section is due to a name change for the organism from Enterobacter to Klebsiella. The name change is going into effect in January 2020. These changes will decrease the annual burden of this form by 125,800 hours.
57.141	Monthly Reporting Plan for LTCF	No change	Decrease number of respondents from 2,600 to 2,220.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified an overestimation in 2018. Thus, annual LTC facility response for this form is estimated to decrease during the 2019 reporting year. This change will decrease the annual burden of this form by 380 hours.
57.142	Denominators for LTCF Locations	No change	Decrease number of respondents from 2,600 to 2,220.	NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified an overestimation in 2018. Thus, annual LTC facility response for this form is estimated to decrease during the 2019 reporting year. This change will decrease the annual burden of this form by 19,000 hours.
57.143	Prevention Process Measures Monthly Monitoring for LTCF	No change	Decrease number of respondents from 2,600 to 375	1.NHSN has revised the methods used to calculate the annual burden for this form. NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN (number of responses) for data reporting purposes. These reports were used to assist with estimating annual burden and identified an overestimation in 2018. Thus, annual LTC facility response for this form is estimated to decrease during the 2019 reporting year. This change will decrease the annual burden of this form by 2,225 hours.
**57.150	Patient Safety Component- Annual Facility Survey for LTAC	No change	Modify response option #42.	Additional options added after reviewing free-text responses from previous survey. This will not have an impact on the annual burden of this from.
**57.151	Patient Safety Component-Annual Facility Survey for IRF	No change	Modify response option #42.	Additional options added after reviewing free-text responses from previous survey. This will not have an impact on the annual burden of this from.
57.200	Healthcare Personnel Safety Component Annual Facility Survey	No change	No change	N/A
57.203	Healthcare Personnel Safety Monthly Reporting Plan	No change	No change	N/A
57.204	Healthcare Worker Demographic Data	No change	No change	N/A
57.205	Exposure to Blood/Body Fluids	No change	No change	N/A
57.206	Healthcare Worker Prophylaxis/Treatment	No change	No change	N/A
57.207	Follow-Up Laboratory Testing	No change	No change	N/A
57.210	Healthcare Worker Prophylaxis/Treatment-Influenza	No change	No change	N/A
57.300	Hemovigilance Module Annual Survey	No change	No change	N/A
57.301	Hemovigilance Module Monthly Reporting Plan	No change	No change	N/A
57.303	Hemovigilance Module Monthly Reporting Denominators	No change	No change	N/A
57.304	Hemovigilance Adverse Reaction	No change	No change	N/A
57.305	Hemovigilance Incident	No change	No change	N/A
57.306	Hemovigilance Module Annual Survey - Non-Acute Care Facility	No change	No change	N/A
57.307	Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction	No change	No change	N/A
57.308	Hemovigilance Adverse Reaction - Allergic Transfusion Reaction	No change		N/A
57.309	Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction	No change		N/A
57.310	Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction	No change		N/A
57.311	Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction	No change		N/A
57.312	Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction	No change		N/A
57.313	Hemovigilance Adverse Reaction - Infection	No change		N/A
57.314	Hemovigilance Adverse Reaction - Post Transfusion Purpura	No change		N/A
57.315	Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea	No change		N/A
57.316	Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease	No change		N/A
57.317	Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury	No change		N/A
57.318	Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload	No change		N/A
57.319	Hemovigilance Adverse Reaction - Unknown Transfusion Reaction	No change		N/A
57.320	Hemovigilance Adverse Reaction - Other Transfusion Reaction	No change		N/A
57.400	Outpatient Procedure Component (OPC)—Annual Facility Survey	No change	Decrease the number of annual respondents from 5,000 to 700.	NHSN has revised the reports used to calculate the annual burden for this form. Reporting to OPC began in November 2018, and we overestimated the number of facilities actively reporting data to NHSN during the rollout of OPC. Previously reported facility information was based on the total number of ASC facilities using NHSN. We estimate 700 facilities reporting in 2019 based on 625 actual enrolled facilities using OPC and added 75 (12%) to allow for growth. This change will decrease the estimated annual burden of this form by 717 hours.
57.401	Outpatient Procedure Component - Monthly Reporting Plan (MRP)	No change	Decrease the number of annual respondents from 5,000 to 700. Decrease the time burden of this form by 5 minutes	NHSN has revised the reports used to calculate the annual burden for this form. Reporting to OPC began in November 2018, and we overestimated the number of facilities actively reporting data to NHSN during the rollout of OPC. Previously reported facility information was based on the total number of ASC facilities using NHSN. We estimate 700 facilities reporting in 2019 based on 625 actual enrolled facilities using OPC and added 75 (12%) to allow for growth. We assumed that the same number of facilities that completed the Annual Facility Survey will complete a MRP each month. The time to complete this form was decreased from 20 minutes to 15 minutes. These changes will decrease the estimated annual burden of this form by 17,900 hours.
57.402	Outpatient Procedure Component Same Day Outcome Measures (SDOM)	No change	Decrease the number of annual respondents from 1,200 to 200. Decreases the number of responses per respondent from 25 to 10.	NHSN has revised the reports used to calculate the annual burden for this form. Reporting to OPC began in November 2018, and we overestimated the number of facilities actively reporting data to NHSN during the rollout of OPC. Previously reported facility information was based on the total number of ASC facilities using NHSN. We assumed that a small percentage (approx. 25-28%) of the facilities that completed the Annual Facility Survey will participate in SDOM and there will be a very low number of events reported, thus an estimate of 200 facilities. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. Since Nov. 2018, 3544 encounters and 2-SDOM (approx. 2/quarter) events were reported. If we estimate an average of 300 encounters per month, per facility, and an SDOM rate of 0.25%, this would give us a SDOM count of 9 per facility. This was rounded up to 10 events per facility. These changes will decrease the estimated annual burden of this form by 19,836 hours
57.403	Outpatient Procedure Component - Monthly Denominators for Same Day Outcome Measures	No change	Decrease the number of annual respondents from 1,200 to 200. Increase the number of responses per respondent from 12 to 400.	NHSN has revised the reports used to calculate the annual burden for this form. Reporting to OPC began in November 2018, and we overestimated the number of facilities actively reporting data to NHSN during the rollout of OPC. Previously reported facility information was based on the total number of ASC facilities using NHSN. We assumed that a small percentage (approx. 25%) of the facilities that completed the Annual Facility Survey will participate in SDOM. The SDOM denominator is encounters. Since Nov 2018, the sum of encounters from 12 facility- months reporting is 3544. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN. These changes will increase the estimated annual burden of this form by 43,733 hours.
57.404	Outpatient Procedure Component – SSI Denominators	No change	Decrease the number of annual respondents from 5,000 to 700. Decrease the number of responses per respondent from 540 to 100.	NHSN has revised the reports used to calculate the annual burden for this form. Reporting to OPC began in November 2018, and we overestimated the number of facilities actively reporting data to NHSN during the rollout of OPC. Previously reported facility information was based on the total number of ASC facilities using NHSN. We estimate 700 facilities reporting in 2019 based on 625 actual enrolled facilities using OPC and added 75 (12%) to allow for growth. We assumed that all of the facilities that completed the Annual Facility Survey will more than likely participate in SSI surveillance. We estimated 100 SSI Denominator records per facility/year with 5 SSI event records, based on 24,300 2018-SSI Denominator records for 642 OrgIDs = 40/year and 8 SSI events/year. These changes will decrease the estimated annual burden of this form by 403,333 hours.
57.405	Outpatient Procedure Component - Surgical Site (SSI) Event	No change	Decrease the number of annual respondents from 5,000 to 700. Decreases the number of responses per respondent from 36 to 5.	NHSN has revised the reports used to calculate the annual burden for this form. Reporting to OPC began in November 2018, and we overestimated the number of facilities actively reporting data to NHSN during the rollout of OPC. Previously reported facility information was based on the total number of ASC facilities using NHSN. We estimate 700 facilities reporting in 2019 based on 625 actual enrolled facilities using OPC and added 75 (12%) to allow for growth. We assumed that all of the facilities that completed the Annual Facility Survey will more than likely participate in SSI surveillance. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses based on the new responses by facility reports we have implemented. We estimated 5 SSI events per facility. These changes will decrease the estimated annual burden of this form by 102,667 hours.
**57.500	Outpatient Dialysis Center Practices Survey	No change	Increase the number of annual respondents from 7,000 to 7,100. Response options modified for questions #3a, #20, and #64. New required question added #9, #12, #65b.	Annual facility participation increased during the 2019 reporting year due to newly enrolled dialysis facilities in NHSN. #3a) currently there are two major accrediting organizations. This modification will help eliminate false responses and therefore the data captured would reflect accurate information. #20) this addition is added because adverse events occur in the patient setting and will help inform guidelines for patient safety and reduction of bloodstream infections. #64) making each response option yes/no to make it easier for the users to respond to each option. #9) question added to estimate the prevalence of dialysis services in an outpatient setting provided by long term care facilities. #12) to accurately assess the infection control practices, which can inform best practices for reducing bloodstream infections.#65b) the addition of this question will inform future education/guidance for NHSN our users on best practices for catheter care and reduction of bloodstream infections. These changes will increase the estimated annual burden of this form by 212 hours.
57.501	Dialysis Monthly Reporting Plan	No change	Increase the number of annual respondents from 7,000 to 7,100. Decrease the burden per response per respondent from 20 to 15 minutes.	Annual facility participation increased during the 2019 reporting year due to newly enrolled dialysis facilities in NHSN. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN and the overall reduction of burden. These changes will decrease the estimated annual burden of this form by 17,900 hours.
**57.502	Dialysis Event	No change	Increase the number of annual respondents from 7,000 to 7,100. Decrease the number of responses per year from 60 to 30 responses annually. Update response options in the pathogens and susceptibility section with a name change of the organism ‘Klebsiella’ from ‘Enterobacter’.	Annual facility participation increased during the 2019 reporting year due to newly enrolled dialysis facilities in NHSN. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN and the overall reduction of burden. Updates will align the form with the NHSN application update for 2020. These changes will decrease the estimated annual burden of this form by 86,250 hours.
57.503	Denominators for Dialysis Event Surveillance	No change	Increase the number of annual respondents from 7,000 to 7,100.	Annual facility participation increased during the 2019 reporting year due to newly enrolled dialysis facilities in NHSN. This change will increase the estimated annual burden of this form by 200 hours.
57.504	Prevention Process Measures Monthly Monitoring for Dialysis	No change	Decrease the number of annual respondents from 2,000 to 1,760. Decrease the time burden by 10 minutes from 85 to 75 minutes.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN for data reporting purposes. These reports were used to assist with estimating annual burden and identified that annual facility response for this form would decrease during the 2019 reporting year. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN and the overall reduction of burden. This change will decrease the estimated annual burden of this form by 7,600 hours.
57.505	Dialysis Patient Influenza Vaccination	No change	Increase the number of annual respondents from 325 to 860.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN for data reporting purposes. These reports were used to assist with estimating annual burden and identified that annual facility response for this form would increase during the 2019 reporting year. This change will increase the estimated annual burden of this form by 4,538 hours.
57.506	Dialysis Patient Influenza Vaccination Denominator	No change	Increase the number of annual respondents from 325 to 860. Decrease the number of responses per year from 5 to 1 response annually.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN for data reporting purposes. These reports were used to assist with estimating annual burden and identified that annual facility response for this form would increase during the 2019 reporting year. The number of times this form is completed annually by participants was updated to reflect an accurate number of annual responses to this form for complete reporting into NHSN and the overall reduction of burden. These changes will decrease the estimated annual burden of this form by 199 hours.
**57.507	Home Dialysis Center Practices Survey	No change	Increase the number of annual respondents from 325 to 430. Response options modified for questions #9, #19, #21, #27, #31, #33 and #37. New required question added #3, #7, #10, #11, #16, #20, and 38.	NHSN created new reports in 2019 that accurately provide the number of facilities that have reported to NHSN during the previous calendar year and indicate the number of times an event form is entered into NHSN for data reporting purposes. These reports were used to assist with estimating annual burden and identified that annual facility response for this form would increase during the 2019 reporting year. #9) this addition is added because adverse events occur in the patient setting and will help inform guidelines for patient safety and reduction of bloodstream infections. #19) and #21) reflects the accuracy of the patient setting. Patients in home hemodialysis care are not admitted to a center these patients receive care in a home setting.#27), #31) #33) changing “chlorhexidine with alcohol (e.g., Chloraprep®, Chlorasrub™)” to “chlorhexidine with alcohol (e.g., Chloarprep™, PDI Prevantics®)” to be more inclusive of products that meet or exceed the chlorhexidine recommendation.#37) making each response option ‘yes/no’ to make it easier for the users to respond to each question. #3) question added to have an accurate count of facilities who are accredited by an organization outside of CMS. #7) question added to estimate the prevalence of dialysis services in an outpatient setting provided by long term care facilities. #10) added to estimate how often bloodstream infections are due to hospital admissions. #11) to determine the ability a facility can obtain microbiology lab records from a hospitalization. This addition allows the dialysis component to identify gaps and/or needs in hospital/dialysis facility communication. #16) added to understand and capture vaccination practices in home dialysis settings. Also, to estimate the number of each vaccination type (e.g., Hep B, influenza, and pneumococcal) received for home patients. #20) added to understand facilities screening practices for hepatitis C which will be used to inform future guidance and education for Hepatitis C in home hemodialysis settings. #38) added to understand facilities catheter care practices and policies. This addition will inform future education/guidance to our users on best practices for catheter care and reduction of bloodstream infections. These changes will increase the estimated annual burden of this form by 40 hours.

NHSN Data Collection Forms: Itemized Revisions and Justifications 5