Att D2 - Itemized revisions and justifications

National Healthcare Safety Network (NHSN)

OMB Control No. 0920-0666

Revision Request June 2013

Itemized IC Revisions and Justifications

Form No.	Name	Name in last ICR	Itemized Changes	Justifications
57.100	NHSN Registration Form	No change	No changes	N/A
57.101	Facility Contact Information	No change	Update form to include sections for the new Dialysis Component and Outpatient Procedure Component.	The form was updated to include applicable sections for the new Dialysis Component and Outpatient Procedure Component. This change does not affect the estimated burden of this form.
57.103	Patient Safety Component-Annual Hospital Survey	No change	Reword teaching status question and response options.	Rewording of this question and response options was completed to help users more appropriately select the correct teaching status designation for their facility. This change does not affect the estimated burden of this form.
57.105	Group Contact Information	No change	No changes	N/A
57.106	Patient Safety Monthly Reporting Plan	No change	Under the Device-Associated Module section, remove “DE” event.	Dialysis events (DE) will now be entered into the NHSN Dialysis Component only. Additionally, because dialysis facilities will no longer be using the NHSN Patient Safety Component, the estimated number of facilities completing this form was reduced to 6,000. While the change to the form will not affect the time to complete the form, the burden hours will be reduced to 42,000 due to the decreasing estimate of facilities using this form resulting in a decrease of 28,000 burden hours.
57.108	Primary Bloodstream Infection (BSI)	No change	Add a new optional question to assess whether the patient had a hemodialysis catheter in place at the time of the event. Revision of antibiogram requirements.	Providing users with ability to note the presence of a hemodialysis catheter will allow them to ascertain what the approximate proportion of their primary bloodstream infections are occurring among hemodialysis patients. If a high proportion of bloodstream infections are occurring among hemodialysis patients, bloodstream infection prevention efforts should focus on the dialysis staff who access the hemodialysis catheters, who otherwise may not be included in prevention activities. The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. These changes result in a decrease of 10,800 burden hours.
57.111	Pneumonia (PNEU)	No change	Revision of antibiogram requirements.	The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. This change results in a decrease of 21,600 burden hours for this form.
57.112	Ventilator-Associated Event	No change	Revision of antibiogram requirements.	The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. This change results in a decrease of 43,200 burden hours for this form.
57.114	Urinary Tract Infection (UTI)	No change	Modify the response options for the catheter status question. Revision of antibiogram requirements.	The previous options for catheter set were developed before 2013 NHSN change to require catheter was present for > 2 days to associate a UTI with an indwelling urinary catheter. Additionally in 2013, the date of event was changed from the date of the first symptom until the date of the last element used to meet the UTI criteria. Because of this, these changes are necessary to capture the status of the indwelling catheter at the time of the event and its association with the UTI. The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. These changes result in a decrease of 8,100 burden hours for this form.
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	Increase number of annual responses per respondent from 18 to 54.	Due to CMS mandated reporting, facilities will now be required to submit summary data from all ICUs and select ward units. It is estimated that each facility has 4.5 units that they are required to report data from resulting in an increase of annual responses per respondent. This change results in the addition of 1,080,000 burden hours for this form.
57.120	Surgical Site Infection (SSI)	No change	Change ‘incision deliberately opened by surgeon’ to ‘incision deliberately opened/drained.’ Add ‘sinus tract’ as a new response option in the Signs and Symptoms section. Add ‘positive culture from > 2 separate tissue or fluid samples from affected joint’ to Laboratory section. Add new question to identify whether the SSI was detected using the NHSN ICD Code-based Admit and Readmit SSI Surveillance Toolkit. Revision of antibiogram requirements.	The previous wording was too restrictive as incisions can be opened or drained by healthcare personnel other than surgeons. This field was needed to allow reporting of new organ/space SSI specific site, periprosthetic joint infection (PJI). This field was also needed to allow reporting of new organ/space SSI specific site, periprosthetic joint infection (PJI). This question was added as NHSN methodology will require the use of discharge diagnosis codes as part of required surveillance beginning in 2014. The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. These changes result in a net decrease of 10,800 burden hours for this form.
57.121	Denominator for Procedure	No change	Diabetes mellitus, height, weight, and closure technique will now be required fields for all SSI events. Remove response option of ‘unknown’ for wound class question. Remove ‘lateral transverse’ and add ‘transoral’ as response options for Approach/Technique question. Add new section applicable only to hip prosthesis and knee prosthesis SSI events.	These fields are important for risk adjustment for SSI event reporting and not currently required for most NHSN procedure types. Wound class is routinely assigned and should not be ‘unknown.’ These changes were made to accommodate evolving surgical practices as transoral is an approach option for spinal procedures. Prior hip prosthesis and knee prosthesis procedure information did not include revision and primary designations sufficient for adequate stratification of procedures for surgical performance comparison. These changes do not affect the estimated burden of this form.
57.123	Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables	No change	Edits made to requested variables and form reformatted.	Edits were made to the requested variables to accurately reflect changes in the requested data. This change does not affect the estimated burden.
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	Revision of antibiogram requirements.	The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. This change results in a decrease of 21,600 burden hours for this form.
57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	No change	Add question regarding which C. difficile test type was used by the facility’s laboratory.	The quarterly risk adjustment for CDI LabID surveillance relies partly on information regarding the testing method for detecting C. difficile. This is currently reported on the retrospective, annual hospital survey. Given the volume of hospitals that are currently switching to more sensitive tests, it is necessary for CDC to collect more current information on this testing method. Specifically, we would collect this information once per quarter in order to align with the risk adjustment methods and provide a more appropriate risk adjustment for each facility’s current practices. This change results in the addition of 4,800 burden hours to this form.
57.128	Laboratory-identified MDRO or CDI Event	No change	No changes	N/A
57.130	Vaccination Monthly Monitoring Form-Summary Method	No change	Decrease the total number of respondents from 6,000 to 100.	Further review and evaluation of reporting into this module shows that very few facilities are collecting this data. Therefore, the total number of respondents completing this form has been decreased from 6,000 to 100. This change results in a decrease of 413,000 burden hours for this form.
57.131	Vaccination Monthly Monitoring Form-Patient-Level Method	No change	Decrease the total number of respondents from 2,000 to 100.	Further review and evaluation of reporting into this module shows that very few facilities are collecting this data. Therefore, the total number of respondents completing this form has been decreased from 2,000 to 100. This change results in a decrease of 19,000 burden hours for this form.
57.133	Patient Vaccination	No change	Decrease the total number of respondents from 2,000 to 100.	Further review and evaluation of reporting into this module shows that very few facilities are collecting this data. Therefore, the total number of respondents completing this form has been decreased from 2,000 to 100. This change results in a decrease of 79,167 burden hours for this form.
57.137	Long-Term Care Facility Component – Annual Facility Survey	No change	No changes	N/A
57.138	Laboratory-identified MDRO or CDI Event for LTCF	No change	No changes	N/A
57.139	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	No change	No changes	N/A
57.140	Urinary Tract Infection (UTI) for LTCF	No change	Add question ‘Did the resident have an indwelling catheter at the time of transfer to your facility?’ Reword catheter status question to ‘Indwelling catheter status at the time of event onset.’ Add question ‘If indwelling urinary catheter was not in place, was another urinary device type present at the time of event onset?’ Add clarifying language ‘Specimen collected from..’ to response options in Laboratory and Diagnostic Testing section. Change two questions to decrease follow-up time from 30 days to 7 days for whether the patient died and whether the patient was transferred to an acute care facility. Remove date of transfer question for events that resulted in a transfer to an acute care facility. Revision of antiobiogram requirements.	This response was provided at the request of nursing home providers to enable them to capture when residents were transferred to the nursing home with an indwelling urinary catheter in place. Change was made for clarification based on user feedback. This optional response was provided at the request of nursing home providers to enable additional data on UTI events to be ascertained. Change was made for clarification based on user feedback. Feedback from nursing home providers identified that the previous follow-up time of 30 days was too difficult to ascertain and the decision was made to decrease the follow-up time in order to reduce burden of data collection. According to nursing home provider feedback, this field was not felt to be useful for facilities. The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. These changes result in a net decrease of 113 burden hours for this form.
57.141	Monthly Reporting Plan for LTCF	No change	No changes	N/A
57.142	Denominators for LTCF Locations	No change	No changes	N/A
57.143	Prevention Process Measures Monthly Monitoring for LTCF	No change	No changes	N/A
57.150	Patient Safety Component- Annual Facility Survey for LTAC	No change	No changes	N/A
57.151	Patient Safety Component-Annual Facility Survey for IRF	No change	No changes	N/A
57.200	Healthcare Personnel Safety Component Annual Facility Survey	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.200, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 400 hours.
57.203	Healthcare Personnel Safety Monthly Reporting Plan	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.203, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 75 hours.
57.204	Healthcare Worker Demographic Data	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.204, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 3,333 hours.
57.205	Exposure to Blood/Body Fluids	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.205, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 2,500 hours.
57.206	Healthcare Worker Prophylaxis/Treatment	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.206, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 375 hours.
57.207	Follow-Up Laboratory Testing	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.207, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 625 hours.
57.210	Healthcare Worker Prophylaxis/Treatment-Influenza	No change	Decrease number of respondents from 100 to 50.	Based on analysis of current user base using Form 57.210, it is unlikely that the number of respondents will exceed 50. This change decreases the estimated burden of this form by 4,583 hours.
57.300	Hemovigilance Module Annual Survey	No change	In questions 1, 2, 4, 8, and 11, response options have been added and arranged in a more logical order. Question 3 has been made required. Questions 16 and 18 have been re-worded. The manner in which question 17 is collected has changed slightly. Optional question 25 has been removed. All questions following have been re-numbered. Grammar and style changes have been made throughout the document.	These changes were made in response to user feedback and common text responses entered as ‘other’ on the data collection form. This question is answered more than 95% of the time and should be answered by all users. Changed for clarity based on user feedback. This change will encourage users to respond to the question completely. The question is rarely answered, provides little value for national collection, and takes up too much space on the form. Grammar and style changes were made for clarity and for accuracy in terminology. These changes have no effect on estimated response burden.
57.301	Hemovigilance Module Monthly Reporting Plan	No change	The surveillance options available to users have been simplified.	Due to changes in the surveillance protocol, the monthly reporting plan has been simplified such that the facility has only one option to select. The user will select pre-defined options indicating whether or not complete surveillance will be conducted during the month. This change decreases the estimated burden of this form by 100 hours.
57.302	Hemovigilance Module Monthly Incident Summary	No change	This form will be removed from the package as it is no longer required for completion according to the NHSN Biovigilance Component surveillance protocol.	After evaluation of the NHSN Biovigilance Component reporting requirements, it was determined that monthly incident summary reporting should no longer be included as required surveillance at this time due to the high degree of variability in reporting capabilities and coding practices across facilities. Removing this form decreases the package burden by 12,000 burden hours.
57.303	Hemovigilance Module Monthly Reporting Denominators	No change	Whole Blood has been added as a product type. Rows have been added for user entry of unmodified blood products transfused. A column has been added to collect total monthly discards of blood products. ‘Patient samples collected’ has been clarified. ‘Total crossmatch procedures’ has been added as a required field. ‘Total patients transfused’ has been added as an optional field.	Whole blood is rarely transfused, but does occur and sometimes results in a patient reaction. The row was added because this particular product does not fit within any other existing category. This information was previously derived from the data entered by users. However, it was not intuitive and resulted in poor data quality in some cases. Adding it as a specified category will increase data quality. Discarded products are sometimes related to errors that occur. Adding this data collection will allow users to track their utilization and relate it to incidents that occur, thereby giving them an opportunity to identify interventions or changes in practice to minimize unnecessary waste and alleviate potential blood product shortages. This question was often misinterpreted and has been clarified. Total crossmatch procedures will serve as a denominator for sample testing errors. This question will be difficult for many users to answer with accuracy, but will serve as a useful denominator for patient adverse reactions. We will phase it in as a required field over time and after sufficient training has been provided. These changes increase the reporting burden by 3,000 hours annually.
57.304	Hemovigilance Adverse Reaction	No change	Added nausea/vomiting as a symptom option. Added additional fields to allow for reporting of multiple antibodies detected resulting from a delayed serologic transfusion reaction. Clarified the ‘unknown’ reaction type and the ‘unit implicated’ question. Added language to specify that the END of the transfusion should be used to determined date and time of the transfusion. The estimated response burden for this form has been increased to 15 minutes. However, protocol changes reduce the total number of expected adverse reaction reports by 60%. The estimated number of responses per respondent has been decreased from 120 to 40.	‘Nausea/vomiting’ is often entered as a text response, so it has been added as a common symptom of transfusion reactions. Previously, users were required to enter multiple reaction records when multiple antibodies were detected. However, when the antibodies result from the same transfusion event, the reaction should only be reported once, but include all antibodies that are identified. Edited language to clarify per user feedback. The adverse reaction case definitions are based on the end of a transfusion. The question previously asked for the start date and time. The question has been clarified to agree with the surveillance case definitions. Users repeatedly inform us that 10 minutes is an underestimate for response time for this form. Three years of surveillance data indicate that the initial estimate of expected adverse reactions was high, so the number of expected reports was reduced by 20%. In addition, a large category of adverse reactions (i.e., minor allergic reactions) was dropped from required for surveillance, which further reduces the expected number of reports by approximately 50%. These form and protocol changes result in a net decrease of 4,000 burden hours annually.
57.305	Hemovigilance Incident	No change	Reduce the estimated responses per respondent from 72 to 12.	There are no changes to the data collection forms, but changes to the surveillance protocol reduce the expected number of incident reports by more than 80%. This change results in a net decrease of 5,000 burden hours for this form.
57.400	Outpatient Procedure Component—Annual Facility Survey	N/A. These forms are new.	Four new forms are being added as part of the new NHSN Outpatient Procedure Component.	The NHSN Outpatient Procedure Component (OPC) was developed amid increasing interest in the public health impact of infections and other outcomes related to outpatient procedures that are performed in settings such as Ambulatory Surgery Centers (ASCs), Hospital Outpatient Departments (HOPDs), and physicians’ offices. The OPC provides surveillance methods to identify and track process and outcomes measures of outpatient procedures that are performed in freestanding ASCs. Three event types are included in the NHSN Outpatient Procedure Component (OPC) and planned for implementation beginning in 2014: Same Day Outcome Measures, Prophylactic Intravenous (IV) Antibiotic Timing, and Surgical Site Infection (SSI). These four new forms will add a total of 138,750 burden hours to this ICR.
57.401	Outpatient Procedure Component - Monthly Reporting Plan
57.402	Outpatient Procedure Component Event
57.403	Outpatient Procedure Component - Monthly Denominators and Summary
57.500	Outpatient Dialysis Center Practices Survey	Patient Safety Component-Outpatient Dialysis Center Practices Survey (previously 57.104)	Remove 11 questions. Rewording throughout the form. Change/add answer response for numerous questions. Following question #5, add conditionally required question and appropriate response space: “If yes, name of group or chain.” Following question #10, add required question and appropriate answer responses: “Does your center routinely screen patients for tuberculosis (TB) on admission to your center?” Following new question #11, add required question and appropriate answer responses: “Does your center routinely maintain records of patients’ hemodialysis station assignment?” Following new question #12, add required question and appropriate answer responses: “Does your center routinely maintain records of patients’ hemodialysis machine assignment?” Following new question #13, add required question and appropriate answer responses: “If a patient from your center was hospitalized, how often is your center able to determine if a bloodstream infection contributed to their hospital admission?” Following new question #14, add required question and appropriate answer responses: “How often is your center able to obtain a patient’s microbiology lab records from a hospitalization?” Following new question #15, add required question and appropriate answer responses: “Was your center operational during the first week of February?” Following question #22, add required question and appropriate answer responses: “Which type of pneumococcal vaccine does your center offer to patients?” Following question #24a, add required question and appropriate response space: “Of these patients who were hepatitis B surface ANTIGEN (HBsAg) positive in the first week of February, how many were positive when first admitted to your center?” Following question #24b, add required question and appropriate answer responses: “Does your center routinely screen hemodialysis patients for hepatitis C antibody (anti-HCV) on admission to your center?” Following new question #25, add required question and appropriate answer responses: “Does your center routinely screen hemodialysis patients for hepatitis C antibody (anti-HCV) at any other time?” Following new question #26, add required question and appropriate answer responses: “If yes, how frequently?” Following question #27a, add required question and appropriate answer responses: “Of these patients who were hepatitis C antibody positive in the first week of February, how many were positive when first admitted to your center?” Following question #28d, add required question and appropriate answer responses: “What type of dialysate is used for in-center hemodialysis patients at your center?” Following new question #29, add required question and appropriate answer responses: “Does your center routinely test dialysate from the patient’s machine for culture and endotoxin whenever a patient has a pyrogenic reaction?” Following question #38, add required question and appropriate answer responses: “Does your center perform hand hygiene audits of staff monthly (or more frequently)?” Following new question #39, add required question and appropriate answer responses: “Does your center perform observations of staff vascular access care and catheter accessing practices quarterly (or more frequently)?” Following new question #40, add required question and appropriate answer responses: “Does your center perform staff competency assessments for vascular access care and catheter accessing annually (or more frequently)?” Following question #45a, add required question and appropriate answer responses: “How many of your fistula patients undergo buttonhole cannulation? “ Following question #46a, add required question and appropriate answer responses: “Is antimicrobial ointment (e.g., mupirocin) routinely used at buttonhole cannulation sites to prevent infection?” Following question #47a, add required question and appropriate answer responses: “Are catheter hubs routinely scrubbed after the cap is removed and before accessing the catheter (or before accessing the catheter via a needleless connector device, if one is used)?” Following question #54, add optional “Comments” field Increase number of annual respondents from 5,700 to 6,000.	Given analytic results of previous surveys and subject matter expert opinion, these questions have been removed. References to “January” or “first week of January” have been changed to “February” or “first week of February” to better align survey completion with anticipated NHSN release dates. References to “dialysis facility” or “facility” have been changed to “dialysis center” or “center” to establish consistency when referencing the outpatient dialysis center for which the survey is being completed. Section sub-headers have been added to help organize and clarify questions pertaining to the same topic. The definition of a required question has been changed to “required to save as complete” since users will have the ability to save incomplete surveys without answer all required questions. The text within the general survey instructions has been modified to provide clarification. The wording of 25 questions has been modified to provide clarification. The answer responses to these questions have been modified to gather more detailed information or simplification of the question. The question “If yes, name of group or chain” has been added to gather information about associations between individual dialysis centers and their association with groups/chains of dialysis centers. The question “Does your center routinely screen patients for tuberculosis (TB) on admission to your center?” has been added to gather individual center information on tuberculosis screening practices among incoming patients. The question “Does your center routinely maintain records of patients’ hemodialysis station assignment?” has been added to gather information on whether or not dialysis centers document patient station assignment for each treatment. The question “Does your center routinely maintain records of patients’ hemodialysis machine assignment?” has been added to gather information on whether or not dialysis centers document patient station assignment for each treatment. The question “If a patient from your center was hospitalized, how often is your center able to determine if a bloodstream infection contributed to their hospital admission?” has been added to gather information on the degree of burden on outpatient dialysis centers to obtain details associated with a patient’s hospitalization. The question “How often is your center able to obtain a patient’s microbiology lab records from a hospitalization?” has been added to gather information on the degree of burden on outpatient dialysis centers to obtain details associated with a patient’s hospitalization, particularly with regards to microbiology records. The question “Was your facility operational during the first week of February?” has been added to determine whether the facility was open and operational during the designated time period referenced for subsequent survey questions or if the facility opened after the designated time period. The question “Which type of pneumococcal vaccine does your center offer to patients?” has been added to gather information regarding the specific type of pneumococcal vaccine that is offered, if any. The question “Of these patients who were hepatitis B surface ANTIGEN (HBsAg) positive in the first week of February, how many were positive when first admitted to your center?” has been added to help refine the information gathered from the center regarding the presence of hepatitis B surface antigen among their patients. The question “Does your center routinely screen hemodialysis patients for hepatitis C antibody (anti-HCV) on admission to your center?” has been added to help generate cleaner data with regards to anti-HCV. The question “Does your center routinely screen hemodialysis patients for hepatitis C antibody (anti-HCV) at any other time?” has been added to help generate cleaner data with regards to anti-HCV. The question “If yes, how frequently?” has been added as a follow-up question to “Does your center routinely screen hemodialysis patients for hepatitis C antibody (anti-HCV) at any other time?” to help generate cleaner data with regards to anti-HCV. The question “Of these patients who were hepatitis C antibody positive in the first week of February, how many were positive when first admitted to your center?” has been added to help refine the information gathered from the outpatient dialysis centers regarding the presence of hepatitis C antibody among their patients. The question “What type of dialysate is used for in-center hemodialysis patients at your center?” has been added to gather information on the quality of dialysate that is being used at outpatient dialysis centers. The question “Does your center routinely test dialysate from the patient’s machine for culture and endotoxin whenever a patient has a pyrogenic reaction?” has been added to gather information about the dialysate testing practices at outpatient dialysis centers. The question “Does your center perform hand hygiene audits of staff monthly (or more frequently)?” has been added to gather information on center practices with regards to assessing hand hygiene adherence as it relates to infection prevention. The question “Does your center perform observations of staff vascular access care and catheter accessing practices quarterly (or more frequently)?” has been added to gather information on center practices with regards to assessing vascular access care and catheter accessing procedures as they relate to infection prevention. The question “Does your center perform staff competency assessments for vascular access care and catheter accessing annually (or more frequently)?” has been added to gather information on center practices with regards to assessing staff competency assessments for vascular access care and catheter accessing as they relate to infection prevention. The question “How many of your fistula patients undergo buttonhole cannulation?“ has been added to help determine the scope of buttonhole cannulation practice and how many patients are impacted by this practice. The question “Is antimicrobial ointment (e.g., mupirocin) routinely used at buttonhole cannulation sites to prevent infection?” has been added to gather information on center practices regarding the use of antimicrobial ointment as prophylaxis at buttonhole cannulation sites. The question “Are catheter hubs routinely scrubbed after the cap is removed and before accessing the catheter (or before accessing the catheter via a needleless connector device, if one is used)?” has been added to gather information on center practices regarding the scrubbing of catheter hub caps before accessing catheters as it relates to infection prevention. The optional “Comments” field has been added to provide a space for survey respondents to include additional explanatory text as desired. The number of annual respondents was increased from 5,700 to 6,000 to capture the universe of dialysis facilities. These changes result in a net increase of 1,950 burden hours for this form.
57.501	Dialysis Monthly Reporting Plan	N/A. This is a new form.	This form is being added as part of the new NHSN Dialysis Component.	Over the past year, the number of outpatient dialysis facilities participating in NHSN has increased exponentially. As of May 13, 2013, there were approximately 5,700 outpatient dialysis facilities enrolled in NHSN, accounting for about 50% of all facilities in NHSN. Historically, dialysis surveillance has been a module within the Patient Safety Component along with modules for surveillance in inpatient healthcare settings. However, the outpatient dialysis setting is very different than inpatient healthcare settings, and the type of NHSN user representing outpatient dialysis facilities is different than most NHSN users representing inpatient healthcare settings. Two goals are achieved by moving dialysis to its own NHSN component: Tailor the NHSN user interface for dialysis users to simplify their data entry and analysis processes. Provide options for expanding the Dialysis Component in the future to include dialysis surveillance in settings other than outpatient facilities (e.g., home hemodialysis, peritoneal dialysis, etc.). This new form will add 6,000 burden hours to this ICR.
57.502	Dialysis Event	Change only in form number (previously 57.109)	Addition of “Urinary Tract Infection” variable. Addition of “Loss of Vascular Access” outcome variable. Revision of antibiogram requirements. Increase number of annual respondents from 5,700 to 6,000.	Following an analysis of user responses to the “Other problem, specify” category, urinary tract infection was identified as a common write-in response. This addition will reduce data entry burden for users, as well as improve data quality. To administer life-saving hemodialysis treatment, a vascular access (a method to access a patient’s veins) is required. An event (such as infection) that results in the inability to use a vascular access can be life-threatening. Therefore, loss of a vascular access is a serious event outcome on par with, but distinct from, the current Dialysis Event outcomes (hospitalization and death). Collection of this outcome information will further inform the impact that infection events can have on dialysis patients. The breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Of those that are tracked and reported, the remaining required organisms and antimicrobials are among the most common to cause HAIs reported into NHSN. As these organisms cause the most serious resistant infections, it is important to infection prevention and control that these requirements remain. The number of annual respondents was increased from 5,700 to 6,000 to capture the universe of dialysis facilities. These changes result in a net decrease of 13,200 burden hours for this form.
57.503	Denominator for Outpatient Dialysis	Change only in form number (previously 57.119)	Addition of an optional “Comments” box Increase number of annual respondents from 5,700 to 6,000.	Providing users with the option of adding comments increases the clinical significance and interpretability of their surveillance data. It is also consistent with the structure of other NHSN forms. The number of annual respondents was increased from 5,700 to 6,000 to capture the universe of dialysis facilities. These changes result in a net increase of 360 burden hours for this form.
57.504	Prevention Process Measures Monthly Monitoring for Dialysis	N/A. These are new forms.	These forms are being added as part of the new NHSN Dialysis Component.	Over the past year, the number of outpatient dialysis facilities participating in NHSN has increased exponentially. As of May 13, 2013, there were approximately 5,700 outpatient dialysis facilities enrolled in NHSN, accounting for about 50% of all facilities in NHSN. Historically, dialysis surveillance has been a module within the Patient Safety Component along with modules for surveillance in inpatient healthcare settings. However, the outpatient dialysis setting is very different than inpatient healthcare settings, and the type of NHSN user representing outpatient dialysis facilities is different than most NHSN users representing inpatient healthcare settings. Two goals are achieved by moving dialysis to its own NHSN component: Tailor the NHSN user interface for dialysis users to simplify their data entry and analysis processes. Provide options for expanding the Dialysis Component in the future to include dialysis surveillance in settings other than outpatient facilities (e.g., home hemodialysis, peritoneal dialysis, etc.). These new forms will add 6,933 burden hours to this ICR.
57.505	Dialysis Patient Influenza Vaccination
57.506	Dialysis Patient Influenza Vaccination Denominator
57.600	State Health Department Validation Record	N/A. This is a new form.	This form provides a standardized record for state health departments to use during validation of NHSN data.	This new form represents a collection of aggregate validation results that will be collected by state health departments when conducting facility-level validation of NHSN healthcare-associated infection (HAI) data within their jurisdictions using the CDC/NHSN Validation Guidance and Toolkits. The NHSN application will be built to accept these data entries and will maintain a dataset that will provide state health departments with calculations of sensitivity, specificity, and accuracy of the NHSN facility-reported HAI data. This form will add an additional 1,900 burden hours to this ICR.

NHSN Data Collection Forms: Itemized Revisions and Justifications 20