Att D-2 Itemized IC Revisions and Justification

National Healthcare Safety Network (NHSN)

OMB Control No. 0920-0666

Revision Request May 2016

Itemized IC Revisions and Justifications

Form No.	Name	Name in last ICR	Itemized Changes	Justifications
57.100	NHSN Registration Form	No change	Addition of question to indicate facility type.	The facility type question was added to allow tracking of the facility types completing the NHSN enrollment process. This change does not affect the estimated burden of this form.
57.101	Facility Contact Information	No change	No changes	N/A
57.103	Patient Safety Component-Annual Hospital Survey	No change	Removal of Question #2. Removal of select pathogens from Question #3. Updates to Question #10. New response option for Question #12. New question #15 was added. Minor adjustments to language in Questions 16-19. Minor adjustments to Questions #20 – 22, 24, 26, 28, 35. Update to the wording of Question 23. Removal of Question #33.	This information was deemed no longer necessary and was not providing us with useful information anymore. Testing methods did not vary widely between organisms based on earlier data collected in this survey. It was therefore decided that this question only needs to be asked for one gram negative and one gram positive organism to help reduce burden. Antibiotic resistance testing of Candida usually varies by organism species. Therefore, to truly understand the practices in facilities with regards to Candida testing, the question needs to be asked separately for the different species of Candida. After discussion with relevant staff members, this information should be easy to capture in facilities answering this survey. A new test type choice of “NAAT plus EIA, if NAAT positive” was added to account for a shift in CDI testing practices used by hospitals, and allow for appropriate risk-adjustment of CDI in these hospitals. The purpose of this question is to understand the infrastructure supporting infection control programs in facilities. By only including questions about infection preventionists, last year’s survey did not adequately capture the infrastructure and resources designated to infection control in each facility. Adjusting the questions for clarity, and to specify these questions apply to policies in the facilities. This will allow better alignment with the survey questions and how DHQP will interpret the information from these questions. Small language edits were made for clarity and to better represent the intent of the questions. The question has been updated to reflect current practice and to help reduce confusion with the previous version of this question. This change will allow us to incorporate logic and only ask 33b to those facilities where it is relevant. Additional answer categories added to allow us to collect more detailed information on the type of feedback given to prescribers, which will be used to inform national estimates of the presence of stewardship programs. This changes removes ambiguity that was present in the previous versions of these questions. These changes result in an increase of 417 burden hours for this form.
57.105	Group Contact Information	No change	No changes	N/A
57.106	Patient Safety Monthly Reporting Plan	No change	No changes	N/A
57.108	Primary Bloodstream Infection (BSI)	No change	Response options were updated to change the wording from “culture” to organisms identified from “specimens.”	This change will better reflect newer non-culture diagnostic tests that may be used to identify the presence of organisms. This change does not affect the estimated burden of this form.
57.111	Pneumonia (PNEU)	No change	Response options were updated to change the wording from “culture” to organisms identified from “specimens.” Added bronchoalveolar lavage (BAL), protected specimen brushing, and endotracheal aspirates to the form.	This change will better reflect newer non-culture diagnostic tests that may be used to identify the presence of organisms. Added bronchoalveolar lavage (BAL), protected specimen brushing, and endotracheal aspirates to the form to reflect that these are also legitimate specimen sites used to diagnosis pneumonia in certain circumstances. These changes do not affect the estimated burden of this form.
57.112	Ventilator-Associated Event	No change	Response options were updated to change the wording from “culture” to organisms identified from “specimens.”	This change will better reflect newer non-culture diagnostic tests that may be used to identify the presence of organisms. This change does not affect the estimated burden of this form.
57.113	Pediatric Ventilator-Associated Event (PedVAE)	N/A. This is a new form.	A new form is being added as part of the NHSN Patient Safety Component.	The NHSN PedVAE Form was developed amid increasing interest in the public health impact of conditions and complications in mechanically-ventilated neonates and children in acute care hospitals, long term acute care hospitals, and inpatient rehabilitation facilities. PedVAE surveillance will extend NHSN’s current VAE surveillance to pediatric populations (currently, VAE surveillance is only conducted in adult locations). PedVAE surveillance will provide a standardized, evidence-based surveillance method for identifying and tracking incidence and outcomes of ventilator-associated conditions in children in US healthcare facilities. These data may be used by facilities to identify areas where prevention and patient safety efforts may be improved. This new form will add a total of 100,000 burden hours to the ICR.
57.114	Urinary Tract Infection (UTI)	No change	Response options were updated to change the wording from “culture” to organisms identified from “specimens.”	This change will better reflect newer non-culture diagnostic tests that may be used to identify the presence of organisms. This change does not affect the estimated burden of this form.
57.115	Custom Event	N/A. This is a new form.	A new form is being added as part of the NHSN Patient Safety Component.	The NHSN Custom Event Form for reporting of healthcare-associated infections other than CLABSI, CAUTI, VAP, VAE, and SSI was developed amid increasing interest in the public health impact of infections in acute care hospitals, long term acute care hospitals, and inpatient rehabilitation facilities. The Custom Event Form is used by healthcare facilities as part of a standardized, evidence-based surveillance method for identifying and tracking incidence and outcomes of healthcare-associated infections in US healthcare facilities. These data may be used by facilities to identify areas where prevention of healthcare-associated infections may be improved. This new form will add a total of 106,167 burden hours to the ICR.
57.116	Denominators for Neonatal Intensive Care Unit (NICU)	No change	No changes	N/A
57.117	Denominators for Specialty Care Area (SCA)/Oncology (ONC)	No change	No changes	N/A
57.118	Denominators for Intensive Care Unit (ICU)/Other Locations (Not NICU or SCA)	No change	No changes	N/A
57.120	Surgical Site Infection (SSI)	No change	Response options were updated to change the wording from “culture” to organisms identified from “specimens.”	This change will better reflect newer non-culture diagnostic tests that may be used to identify the presence of organisms. This change does not affect the estimated burden of this form.
57.121	Denominator for Procedure	No change	The time estimate for completion of this form was updated to 10 minutes per response.	The time estimate for completion of this form was updated from 5 minutes to 10 minutes to account for facilities completing this surveillance without access to electronic methods of data submission. This change results in an increase in 270,000 burden hours for this form.
57.123	Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables	No change	No changes	N/A
57.124	Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables	No change	No changes	N/A
57.125	Central Line Insertion Practices Adherence Monitoring	No change	No changes	N/A
57.126	MDRO or CDI Infection Form	No change	Response options were updated to change the wording from “culture” to organisms identified from “specimens.”	This change will better reflect newer non-culture diagnostic tests that may be used to identify the presence of organisms. This change does not affect the estimated burden of this form.
57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	No change	New response option was added for CDI test type.	A new test type choice of “NAAT plus EIA, if NAAT positive” was added to account for a shift in CDI testing practices used by hospitals, and allow for appropriate risk-adjustment of CDI in these hospitals. This change does not affect the estimated burden of this form.
57.128	Laboratory-identified MDRO or CDI Event	No change	No changes	N/A
57.129	Adult Sepsis	N/A. This is a new form.	A new form is being added as part of the NHSN Patient Safety Component.	The NHSN Adult Sepsis Module was developed amid increasing interest in the public health impact of sepsis. The Adult Sepsis module provides a standardized, evidence-based surveillance method for identifying and tracking incidence and outcomes of sepsis among adults in US healthcare facilities. These data may be used by facilities to identify areas where sepsis management may be improved. Data may also be used by public health authorities to identify regions and facilities with poor sepsis outcomes and target interventions accordingly. This new form will add a total of 5,208 burden hours to the ICR.
57.137	Long-Term Care Facility Component – Annual Facility Survey	No change	The National Provider ID was added. New response option was added for CDI test type. Minor adjustments to language in Questions 6-9. Three questions were added to the antimicrobial stewardship section. The number of respondents was increased to 350.	The National Provider ID was added to the 2017 annual survey to accommodate the potential for future CMS reporting and data analysis requirements. A new test type choice of “NAAT plus EIA, if NAAT positive” was added to account for a shift in CDI testing practices used by facilities, and allow for appropriate risk-adjustment of CDI in these facilities. Adjusting the questions for clarity, and to specify these questions apply to policies in the facilities. This will allow better alignment with the survey questions and how DHQP will interpret the information from these questions. Three additional antibiotic stewardship questions added to align with the LTCF core elements of antibiotic stewardship. The number of respondents was increased from 250 to 350 to account for the increase in LTCF facilities using the NHSN LTCF Component. These changes result in an increase of 128 burden hours for this form.
57.138	Laboratory-identified MDRO or CDI Event for LTCF	No change	The number of respondents was increased to 350.	The number of respondents was increased from 250 to 350 to account for the increase in LTCF facilities using the NHSN LTCF Component. This change results in an increase of 550 burden hours for this form.
57.139	MDRO and CDI LabID Event Reporting Monthly Summary Data for LTCF	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	Form was renamed. New question was added. Row for “report no events” was added. The number of respondents was increased to 350.	Form was renamed to more accurately reflect the data captured on it. A new question was added to assess the number of admissions on C. difficile treatment. A row was added to check the ‘report no events’ box for the appropriate surveillance type to allow for complete reporting of data on one form. The number of respondents was increased from 250 to 350 to account for the increase in LTCF facilities using the NHSN LTCF Component. These changes result in an increase of 450 burden hours for this form.
57.140	Urinary Tract Infection (UTI) for LTCF	No change	The number of respondents was increased to 350.	The number of respondents was increased from 250 to 350 to account for the increase in LTCF facilities using the NHSN LTCF Component. This change results in an increase of 1,325 burden hours for this form.
57.141	Monthly Reporting Plan for LTCF	No change	The number of respondents was increased to 350.	The number of respondents was increased from 250 to 350 to account for the increase in LTCF facilities using the NHSN LTCF Component. This change results in an increase of 100 burden hours for this form.
57.142	Denominators for LTCF Locations	No change	New question was added. The number of respondents was increased to 350.	A new question was added to assess the number of urine cultures ordered to describe ordering practices of NHSN LTCFs and possibly for future risk adjustment. The number of respondents was increased from 250 to 350 to account for the increase in LTCF facilities using the NHSN LTCF Component. These changes result in an increase of 4,320 burden hours for this form.
57.143	Prevention Process Measures Monthly Monitoring for LTCF	No change	The number of respondents was increased to 300.	The number of respondents was increased from 250 to 300 to account for the increase in LTCF facilities using the NHSN LTCF Component. This change results in an increase of 50 burden hours for this form.
57.150	Patient Safety Component- Annual Facility Survey for LTAC	No change	Removal of Question #2. Removal of select pathogens from Question #3. Updates to Question #10. New response option for Question #12. New question #15 was added. Minor adjustments to language in Questions 16-19. Minor adjustments to Questions #20 – 22, 24, 26, 28, 35. Update to the wording of Question 23. Removal of Question #33.	This information was deemed no longer necessary and was not providing us with useful information anymore. Testing methods did not vary widely between organisms based on earlier data collected in this survey. It was therefore decided that this question only needs to be asked for one gram negative and one gram positive organism to help reduce burden. Antibiotic resistance testing of Candida usually varies by organism species. Therefore, to truly understand the practices in facilities with regards to Candida testing, the question needs to be asked separately for the different species of Candida. After discussion with relevant staff members, this information should be easy to capture in facilities answering this survey. A new test type choice of “NAAT plus EIA, if NAAT positive” was added to account for a shift in CDI testing practices used by hospitals, and allow for appropriate risk-adjustment of CDI in these hospitals. The purpose of this question is to understand the infrastructure supporting infection control programs in facilities. By only including questions about infection preventionists, last year’s survey did not adequately capture the infrastructure and resources designated to infection control in each facility. Adjusting the questions for clarity, and to specify these questions apply to policies in the facilities. This will allow better alignment with the survey questions and how DHQP will interpret the information from these questions. Small language edits were made for clarity and to better represent the intent of the questions. The question has been updated to reflect current practice and to help reduce confusion with the previous version of this question. This change will allow us to incorporate logic and only ask 33b to those facilities where it is relevant. Additional answer categories added to allow us to collect more detailed information on the type of feedback given to prescribers, which will be used to inform national estimates of the presence of stewardship programs. This changes removes ambiguity that was present in the previous versions of these questions. These changes result in an increase of 33 burden hours for this form.
57.151	Patient Safety Component-Annual Facility Survey for IRF	No change	Removal of Question #2. Removal of select pathogens from Question #3. Updates to Question #10. New response option for Question #12. New question #15 was added. Minor adjustments to language in Questions 16-19. Minor adjustments to Questions #20 – 22, 24, 26, 28, 35. Update to the wording of Question 23. Removal of Question #33.	This information was deemed no longer necessary and was not providing us with useful information anymore. Testing methods did not vary widely between organisms based on earlier data collected in this survey. It was therefore decided that this question only needs to be asked for one gram negative and one gram positive organism to help reduce burden. Antibiotic resistance testing of Candida usually varies by organism species. Therefore, to truly understand the practices in facilities with regards to Candida testing, the question needs to be asked separately for the different species of Candida. After discussion with relevant staff members, this information should be easy to capture in facilities answering this survey. A new test type choice of “NAAT plus EIA, if NAAT positive” was added to account for a shift in CDI testing practices used by hospitals, and allow for appropriate risk-adjustment of CDI in these hospitals. The purpose of this question is to understand the infrastructure supporting infection control programs in facilities. By only including questions about infection preventionists, last year’s survey did not adequately capture the infrastructure and resources designated to infection control in each facility. Adjusting the questions for clarity, and to specify these questions apply to policies in the facilities. This will allow better alignment with the survey questions and how DHQP will interpret the information from these questions. Small language edits were made for clarity and to better represent the intent of the questions. The question has been updated to reflect current practice and to help reduce confusion with the previous version of this question. This change will allow us to incorporate logic and only ask 33b to those facilities where it is relevant. Additional answer categories added to allow us to collect more detailed information on the type of feedback given to prescribers, which will be used to inform national estimates of the presence of stewardship programs. This changes removes ambiguity that was present in the previous versions of these questions. These changes result in an increase of 83 burden hours for this form.
57.200	Healthcare Personnel Safety Component Annual Facility Survey	No change	No changes	N/A
57.203	Healthcare Personnel Safety Monthly Reporting Plan	No change	No changes	N/A
57.204	Healthcare Worker Demographic Data	No change	No changes	N/A
57.205	Exposure to Blood/Body Fluids	No change	No changes	N/A
57.206	Healthcare Worker Prophylaxis/Treatment	No change	No changes	N/A
57.207	Follow-Up Laboratory Testing	No change	No changes	N/A
57.210	Healthcare Worker Prophylaxis/Treatment-Influenza	No change	No changes	N/A
57.300	Hemovigilance Module Annual Survey – Acute Care Facility	Hemovigilance Module Annual Survey	The form name was updated.	The title change will allow facilities to identify which survey they should complete. There is a new annual facility survey form for non-acute care facilities. This change does not affect the estimated burden of this form.
57.301	Hemovigilance Module Monthly Reporting Plan	No change	No changes	N/A
57.303	Hemovigilance Module Monthly Reporting Denominators	No change	No changes	N/A
57.304	Hemovigilance Adverse Reaction	No change	This form will be removed from the package.	This single form has been removed from the package and in its place 14 new forms have been added. Removing this form decreases the package burden by 6,000 burden hours.
57.305	Hemovigilance Incident	No change	No changes	N/A
57.306	Hemovigilance Module Annual Survey - Non-Acute Care Facility	N/A. This is a new form.	A new form is being added as part of the NHSN Hemovigilance Component.	Non-acute care facilities can now report to the NHSN Hemovigilance Module. All participating facilities complete an Annual Facility Survey. This new form contains questions specific to non-acute care facilities. The inclusion of non-acute care facilities will broaden the scope of facilities reporting to the Hemovigilance Module. This will allow for more robust data collection to identify emerging trends in transfusion related adverse events among these facilities. This new form will add a total of 117 burden hours to the ICR.
57.307	Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction	N/A. These are new forms.	New forms are being added as part of the NHSN Hemovigilance Component.	The Adverse Reaction form split into one general information form and 14 reaction-specific forms to reduce the length of form. The General form includes questions that will be answered by the majority of facilities and only one reaction-specific form will be completed for each general form. Splitting the form prevents facilities from reading through questions that do not pertain to the transfusion reaction they are submitting. These new forms will add a total of 5,205 burden hours to the ICR.
57.308	Hemovigilance Adverse Reaction - Allergic Transfusion Reaction
57.309	Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction
57.310	Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction
57.311	Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction
57.312	Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction
57.313	Hemovigilance Adverse Reaction - Infection
57.314	Hemovigilance Adverse Reaction - Post Transfusion Purpura
57.315	Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea
57.316	Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease
57.317	Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury
57.318	Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload
57.319	Hemovigilance Adverse Reaction - Unknown Transfusion Reaction
57.320	Hemovigilance Adverse Reaction - Other Transfusion Reaction
57.400	Patient Safety Component—Annual Facility Survey for Ambulatory Surgery Center (ASC)	No change	No changes	N/A
57.401	Outpatient Procedure Component - Monthly Reporting Plan	No change	No changes	N/A
57.402	Outpatient Procedure Component Event	No change	No changes	N/A
57.403	Outpatient Procedure Component - Monthly Denominators and Summary	No change	No changes	N/A
57.500	Outpatient Dialysis Center Practices Survey	No change	Reworded Question #31. Added Questions 31a, 31c. Added Question #37. Rewording Questions 47-48. Change response options for Questions 48, 49bii, 50, 52.	Changed “does your facility routinely test dialysate” to instead ask “does your facility routinely test the following” to expand data collection to include more than just dialysate from the patient’s machine following a pyrogenic reaction (i.e., see #31a and c). Added questions about whether the patient’s “a. blood” or dialysis “c. water” are tested after a patient has a pyrogenic reaction. These questions were added to gather information on national practices about testing following pyrogenic reactions. Added “What form of saline flush is most commonly used?” to determine the national practice related to saline flushes. Inserted “rope-ladder” to clarify the questions pertain only to those arteriovenous fistula and graft patients who do not undergo buttonhole cannulation. Changed the current multiple choice option “sodium hypochlorite solution” to “sodium hypochlorite solution without alcohol” and added a new multiple choice option, “sodium hypochlorite solution followed by alcohol” to determine national practices related to application of sodium hypochlorite. These changes do not affect the estimated burden of this form.
57.501	Dialysis Monthly Reporting Plan	No change	No changes	N/A
57.502	Dialysis Event	No change	Added a new question regarding blood cultures.	Added a question: “If new antimicrobial start, was a blood sample collected for culture?” to determine how often intravenous (IV) antimicrobials are started without first collecting a blood sample, which may lead to excessive and/or inappropriate antimicrobial drug exposure for the patient. (The blood sample is used to identify the pathogen causing the infection and the pathogen’s antimicrobial drug susceptibilities and effectively treat a bloodstream infection.) Excessive and/or inappropriate use of antimicrobial drugs may have poor treatment outcomes for the patient and contribute to the development of multi-drug resistant organisms (MDROs). This change does not affect the estimated burden of this form.
57.503	Denominators for Dialysis Event Surveillance	No change	Change the question to assess the number of patients for whom dialyzers are reused to required.	In 2015 the “Number of these patients for whom dialyzers are reused” was added as an optional field because dialyzer reuse has been identified as important risk factor for infections. By including this field on both numerator and denominator forms, it will be possible to calculate a dialyzer reuse rate. This field will now become required for completion. This change does not affect the estimated burden of this form.
57.504	Prevention Process Measures Monthly Monitoring for Dialysis	No change	No changes	N/A
57.505	Dialysis Patient Influenza Vaccination	No change	No changes	N/A
57.506	Dialysis Patient Influenza Vaccination Denominator	No change	No changes	N/A
57.507	Home Dialysis Center Practices Survey	N/A. This is a new form.	A new form is being added as part of the NHSN Dialysis Component.	Dialysis centers that provide training and support for patients who undergo hemodialysis and/or peritoneal dialysis in their own homes have different practices than centers that provide in-center hemodialysis. The existing “Outpatient Dialysis Center Practices Survey” was tailored to in-center hemodialysis practices and could not be completed correctly by facilities that do not offer that type of care. Therefore a new survey has been created to collect information specific to facilities that support home dialysis patients. Practice information being collected includes: Information about the center’s affiliation, medical records systems, and isolation practices Patient and staff census Vaccination practices Hepatitis screening practices Practices related to cannulation and cleaning of vascular accesses as well as peritoneal catheters This new form will add a total of 250 burden hours to the ICR.

NHSN Data Collection Forms: Itemized Revisions and Justifications 5