Att D.2 Itemized IC Revisions and Justifications

2. Itemized IC Revisions and Justifications.docx

The National Healthcare Safety Network (NHSN)

Att D.2 Itemized IC Revisions and Justifications

OMB: 0920-0666

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National Healthcare Safety Network (NHSN)

OMB Control No. 0920-0666

Revision Request July 2012

Itemized IC Revisions and Justifications

Form No.

Name

Name in last ICR

Itemized Changes

Justifications

57.100

NHSN Registration Form

No change

  1. Decrease the number of respondents from 6,000 to 2,000.

  1. The NHSN Registration form is filled out only once by a facility during the enrollment process. After completing this form, the facility will never have to fill this out again. Furthermore, we expect roughly 2,000 facilities to be enrolling in NHSN in 2013 due to various upcoming reporting mandates and expansion of NHSN surveillance components.

This change results in the decrease of 333 burden hours.

57.101

Facility Contact Information

No change

  1. Decrease the number of respondents from 6,000 to 2,000.

  1. The Facility Contact Information form is filled out only once by a facility during the enrollment process. After completing this form, the facility will never have to fill this out again. Furthermore, we expect roughly 2,000 facilities to be enrolling in NHSN in 2013 due to various upcoming reporting mandates and expansion of NHSN surveillance components.

This change results in the decrease of 667 burden hours.

57.103

Patient Safety Component-Annual Hospital Survey

Patient Safety Component-Annual Facility Survey

  1. Title change to reflect change in instrument use.

  2. Remove “Managed care organization” from Ownership choices.

  3. In the Facility Characteristics section, remove subsection title “For any Hospital except Long Term Care Hospitals”.

  4. In the Facility Characteristics section, change the sub-section title “Number of beds set up and staffed” to “Number of beds set up and staffed in the following location types (as defined by CDC)”; remove the word “beds” from the choices; remove the specialty care bed choice; and change the wording to “All other inpatient locations”.

  5. Allow users to specify the version of antimicrobial susceptibility standards used in their microbiology laboratory.

  6. Reword the question for C. difficile testing methods within the facility’s microbiology laboratory.

  1. Title change to reflect change in instrument use.

  2. A managed care organization is not a true type of ownership rather it is more of an insurance product type and therefore should be removed as a choice.

  3. Long Term Care Hospitals will have their own annual survey so this phrase is no longer necessary on this form.

  4. In order to better validate the number of beds of each type reported on the annual survey to the number of beds attributed to each location mapped in the NHSN application, the text of this subsection needs to be altered. Data on facility bed size captured on the annual survey is used as part of risk adjustment for SSI following certain operative procedures and may be used in the future for risk adjusting other events.   

  5. This change will allow users to more accurately specify the version of antimicrobial susceptibility standards that are used in their lab facilities without needing to update the question on the form and in the application each year when the new version is released.

  6. The clarification of question 13 within the microbiology lab practices section will provide users with a more simplified response and allow for more accurate risk adjustment of this measure.

These changes do not affect the estimated burden of this form.

57.104

Patient Safety Component-Outpatient Dialysis Center Practices Survey

No change

  1. Update header instructions

  2. Order of questions and question numbers have changed

  3. Change wording of “check all that apply” to “select all that apply” in questions: 3, 38a

  4. Change wording of “unit”/”dialysis unit” to “facility”/”dialysis facility” in questions: 6, 7, 9, and 10

  5. Change “CHRONIC hemodialysis patients” to “MAINTENANCE hemodialysis patients” in questions: 12 and 19

  6. Change wording in questions: 5a, 7a, 8, 11, 13, 15, 19b, 20a, 25, 25a, 28, 32, 33, 35, 36, 37, 38, 41, and 42

  7. Change/add answer responses to questions: 5a, 10, 21, 21c, 21d, 26, 30 (change order), 31, 32, 33, 34, 38a, 39a, and 41

  8. Change spelling of “dietician” to “Dietitian”

  9. Change header text beginning Section F: spell-out “arteriovenous (AV)”

  10. In association with question regarding antimicrobial locks, change format of “prevent”

  11. Following question regarding the association with a group or chain of dialysis centers, add required question: “If Yes, managed or operated by”

  12. Add required question: “How many were hepatitis B surface ANTIGEN (HBsAg) positive in the first week of January?”

  13. Following question regarding the testing of hepatitis C antibody, add required question and appropriate answer responses: “If Yes, How frequently? (select all that apply)”

  14. Following question regarding the testing of hepatitis C antibody, add required question: “How many were hepatitis C virus (anti-HCV) antibody positive in the first week of January?”

  15. Following question regarding refrigerating dialyzers, add required question and appropriate answer responses: “How is dialyzer header cleaning performed? (select all that apply)”

  16. Following question regarding refrigerating dialyzers, add required question and appropriate answer responses: “Is there a limit to the number of times a dialyzer is used?”

  17. Add required question and appropriate answer responses: “Do technicians administer any IV medications (e.g., heparin, saline)?”

  18. Add required question and appropriate answer responses: “Does your facility participate in any national or regional infection prevention initiatives?”

  19. Add required question and appropriate answer responses: “If Yes, indicate the primary focus of the initiative(s): (if >1, select all that apply)”

  20. Add required question and appropriate answer responses: “Do you follow CDC-recommended Core interventions to prevent bloodstream infections in hemodialysis patients?”

  21. Add required question and appropriate answer responses: “Indicate the form of skin antiseptic used to prep fistula/graft sites”

  22. Following question regarding buttonhole cannulation among fistula patients, add required question and appropriate answer responses: “If Yes, Indicate for what patients”

  23. Following question regarding buttonhole cannulation among fistula patients, add required question and appropriate answer responses: “If Yes, Buttonhole cannulation is most often performed by”

  24. Add required question and appropriate answer responses: “Indicate the form of antiseptic/disinfectant used to prep the catheter hubs”

  25. Add required question and appropriate answer responses: “Indicate the form of antiseptic/disinfectant used at the exit site”

  26. Add required question and appropriate answer responses: “Of your maintenance hemodialysis patients with a central line in Question 32 (32d + 32e), how many received prophylactic antimicrobial lock in the first week of January?”

  27. Add required question and appropriate answer responses: “Are closed connector luer access devices used on hemodialysis catheters?”

  28. Following question regarding closed connector luer access devices, add required question and appropriate answer responses: “If Yes, Indicate what kind”

  29. Following question regarding closed connector luer access devices, add required question and appropriate answer responses: “If Yes, Indicate for what patients”

  30. Does your facility use hemodialysis machine Waste Handling Option (WHO) ports?

  31. Are any patients in your facility “bled onto the machine” (i.e., where blood is allowed to reach or almost reach the prime waste receptacle or WHO port)?

  1. Headers instructions are being updated for consistency with supporting materials.

  2. Order of questions and question numbers have been changed to make the sequence of the survey flow more smoothly from one topic to another.

  3. Check all that apply” is being replaced by “select all that apply” across NHSN dialysis documentation for consistency.

  4. unit” / ”dialysis unit” is being replaced by “facility” / “dialysis facility” across NHSN dialysis documentation for consistency.

  5. Chronic” is being replaced by “maintenance” across NHSN dialysis documentation for consistency.

  6. Changes in question wording are being made to provide clarity and specification to the questions.

  7. Changes/additions to answer responses are being made to provide additional detail to provided answers and/or to provide more clarity.

  8. The change in spelling of “Dietitian” is a reflection of the change in acceptable spellings promoted by the professional organization of dietitians.

  9. arteriovenous” is included in the first line of text beginning Section F as this is the first time “AV” is used as an abbreviation.

  10. The format of “prevent” is being changed in association with the question regarding antimicrobial locks to bring attention to the word.

  11. With regards to being associated with a group or chain of dialysis centers, the question “If Yes, managed or operated by” was added to capture information pertaining to the management and operations of the facility, which may be overseen by a group or chain of dialysis centers different from the group or chain of dialysis centers that owns the facility.

  12. The question “How many were hepatitis B surface ANTIGEN (HBsAg) positive in the first week of January?” has been added to capture more information regarding the prevalence of hepatitis B surface ANTIGEN among the dialysis patients included as denominators for NHSN dialysis event surveillance.

  13. The question regarding the frequency of testing for hepatitis C antibody has been added to gather more information regarding hepatitis C testing practices in dialysis facilities.

  14. The question “How many were antibody to hepatitis C virus (anti-HCV) positive in the first week of January?” has been added to capture more information regarding the prevalence of antibody to hepatitis C virus among the dialysis patients included as denominators for NHSN dialysis event surveillance.

  15. The question “How is dialyzer header cleaning performed? (select all that apply)” has been added to capture more information regarding the practices of cleaning and reprocessing dialyzers performed by facilities.

  16. The question “Is there a limit to the number of times a dialyzer is used?” has been added to capture more information regarding the reprocessing procedures practiced by the facilities.

  17. The question “Do technicians administer any IV medications (e.g., heparin, saline)?” has been added to capture more information about how patient care is delivered and who is responsible for delivering the patient care.

  18. The question “Does your facility participate in any national or regional infection prevention initiatives?” has been added to gather data regarding the level of interest that dialysis facilities have in participating in infection prevention activities and initiatives.

  19. The question “If Yes, indicate the primary focus of the initiative(s): (if >1, select all that apply)” has been added to determine the key components of infection prevention may be of greatest interest to dialysis facilities.

  20. The question “Do you follow CDC-recommended Core interventions to prevent bloodstream infections in hemodialysis patients?” has been added to determine the level of interest and degree to which the CDC-recommended Core interventions to prevent bloodstream infections in hemodialysis patients are implemented.

  21. The question “Indicate the form of skin antiseptic used to prep fistula/graft sites” has been added to determine what types of skin antiseptics are most commonly used to prep fistula/graft sites and to see how the usage compares with recommendations.

  22. With regards to buttonhole cannulation among fistula patients, the question “If Yes, Indicate for what patients” has been added to gain a better understanding of the practice of buttonhole cannulation and to determine if buttonhole cannulation is being performed on home hemodialysis patients, in-center patients, or both home and in-center hemodialysis patients.

  23. With regards to buttonhole cannulation among fistula patients, the question “If Yes, Buttonhole cannulation is most often performed by” has been added to gain a better understanding of the practice of buttonhole cannulation and to determine if the action of cannulating via buttonhole is being performed by a nurse, the patient, a technician, or someone else.

  24. The question “Indicate the form of antiseptic/disinfectant used to prep the catheter hubs” has been added to determine what type of antiseptic/disinfectant are most commonly used to prep the catheter hubs and to see how the usage compares with recommendations.

  25. The question “Indicate the form of antiseptic/disinfectant used at the exit site” has been added to determine what type of antiseptic/disinfectant are most commonly used to prep the catheter hubs and to see how the usage compares with recommendations.

  26. The question “Of your maintenance hemodialysis patients with a central line in Question 30 (30d + 30e), how many received prophylactic antimicrobial lock in the first week of January?” has been added to determine the frequency of which the prophylactic antimicrobial locks are used.

  27. The question “Are closed connector luer access devices used on hemodialysis catheters?” has been added to determine the frequency of which the closed connector luer access devices used.

  28. With regards to the use of closed connector luer access devices, the question “If Yes, Indicate what kind” has been added to determine what types of these access devices are actually being used.

  29. With regards to the use of closed connector luer access devices, the “If Yes, Indicate for what patients” has been added to determine in what types of patients these access devises are used.

  30. The question “Does your facility use hemodialysis machine Waste Handling Option (WHO) ports?” has been added to determine the prevalence of this practice and possible correlation with infection rates.

  31. The question “Are any patients in your facility “bled onto the machine” (i.e., where blood is allowed to reach or almost reach the prime waste receptacle or WHO port)?” has been added to determine the prevalence of this practice and possible correlation with infection rates.

Additionally, due to CMS mandated reporting, the number of respondents increased from 5,500 to 5,700. Due to these changes, the burden hours of this form increase by 3,050 hours.

57.105

Group Contact Information

No change

No changes

N/A

57.106

Patient Safety Monthly Reporting Plan

No change

  1. Under the Device-Associated Module section, rename “VAP” to “PedVAP” event and add new event type of “VAE”.

  2. Under the Procedure-Associated Module section, remove “PPP” event.

  1. Ventilator-associated pneumonia (VAP) is one of many complications that can occur in patients who are intubated and whose respirations are assisted by mechanical ventilation. The current pneumonia criteria have proven difficult to apply consistently across data collectors and are not amenable to electronic data capture. Therefore, a working group was convened to develop a new paradigm for defining and tracking ventilator-associated complications, including pneumonia. The details are provided elsewhere in this submission (see VAE section). The current VAP event will be restricted to pediatric patients only beginning in 2013 (hence the renaming to PedVAP) and the new VAE will replace the former VAP event for adult patients.

  2. Post-procedure pneumonia (PPP) events have seldom been reported to NHSN under the Procedure-Associated Module and therefore, a decision has been made to remove them from the surveillance protocol and hence from this form.

These changes do not affect the estimated burden however we have increased the average number of responses per year to 12 based on user feedback. Increasing the number of responses per year increases the burden of this form by 38,500 hours.

57.108

Primary Bloodstream Infection (BSI)

No change

  1. Revision of ‘Underlying Conditions’ section that now only includes three check boxes.

  1. The revision of these items and collection of data on the presence of these underlying conditions will be used to classify laboratory confirmed bloodstream infections due to mucosal barrier injuries (MBI-LCBI). This new LCBI classification will increase the specificity of the central line associated bloodstream infection (CLABSI) definition that is used for surveillance, quality measurement and public reporting. This modification to the definition is only for use in defined patient populations. Therefore, the additional burden (estimated to be 2 minutes) to collect these items will not impact all NHSN facilities and locations, only those facilities and locations providing care to specific patient populations.

These changes result in 7200 added burden hours.

57.109

Dialysis Event

No change

  1. Number of times respondent completes form annually decreases from 75 to 60.

  2. Add an optional new question “Was the patient admitted/readmitted to the dialysis facility on the same day as this dialysis event?”

  3. Modify “Other access device (e.g., hybrid)” to “Other access device” and add an optional sub-question “Is this a catheter-graft hybrid?”

  4. Add an optional “Vascular access comment” text box.

  5. Under “Positive blood culture” modify instructions from “specify pathogen” to “specify organism”.

  1. Following the discontinuation of “hospitalization” as a stand-alone dialysis event and addition of the new “pus, redness, or increased swelling at the vascular access site” event in June 2011, facilities had fewer triggers to complete a Dialysis Event form, which is reflected by reduced estimate of 60 dialysis event forms completed per facility annually.

  2. Some dialysis events are reported by dialysis centers, but are attributable to the care they have received in other healthcare settings (e.g., hospitals). This question will provide additional information to distinguish these events from the ones that occur as a result of care provided by the dialysis facility doing the reporting.

  3. Hybrid access devices are relatively new and this sub-question will allow us to determine what proportion they are of “other access devices”. This will inform whether a stand-alone hybrid category is needed for further risk stratification.

  4. A vascular access comment box will permit users to add additional information about the patient’s accesses, to assist them in interpreting their own data (e.g., if a patient has more than 1 of the same type, specify graft material, etc.)

  5. For dialysis reporting, all positive blood cultures are reported, including non-pathogens. This modification will clarify the form to be more consistent with reporting instructions.

Additionally, due to CMS mandated reporting, the number of respondents increased from 5,500 to 5,700. However, these changes decrease the estimated burden of this form by 18,800 hours.

57.111

Pneumonia (PNEU)

No change

  1. The post-procedure pneumonia field will be made optional instead of required.

  1. After reviewing the data submitted to NHSN, use of the post-procedure pneumonia surveillance is extremely limited. Furthermore, in-plan pneumonia surveillance for adult patients will no longer be available within NHSN as of January 2013.

This change does not affect the estimated burden.

57.112

Ventilator-Associated Event

Streamlined Ventilator-Associated Pneumonia (SVAP)

  1. The entire event details section of the form was reworked to reflect refinement of the surveillance definition algorithm.

  2. Additional question was added to Airway Pressure Release Ventilation (APRV) status.

  3. The form was re-titled to more accurately reflect the events that will be captured.

  1. The changes to the form are the result of work done by the VAP Surveillance Definition Working Group, a group composed of CDC staff, other federal partners, and leaders of external stakeholder organizations in order to further define the surveillance algorithm for detecting ventilator-associated events.

  2. APRV is a mode of mechanical ventilation that is increasingly being used in some centers, and may potentially be used in higher-risk patients. Question was added to obtain a better understanding for how commonly this mode is being used and how frequently events are detected in patients receiving this kind of mechanical ventilation.

  3. The form was re-titled to more accurately reflect the events that will be captured.

These changes do not affect the estimated burden.

57.114

Urinary Tract Infection (UTI)

No change

  1. Add birthweight as an optional field.

  2. Modify text of the two choices of urinary catheter status at time of specimen collection from 48 hours to 2 days.

  1. To allow matching of birthweight-specific urinary tract infection events with the appropriate birthweight-specific denominator data for rate calculations.

  2. To align with attribution timing rules that changed from 48 hours to 2 days.

This change does not affect the estimated burden.

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)

Denominators for Specialty Care Area (SCA)

  1. Title change to reflect change in instrument use.

  2. Sub-column of number of patients on Airway Pressure Release Ventilation (APRV) was added under ventilator category.

  1. Title change to reflect change in instrument use.

  2. APRV is a mode of mechanical ventilation that is increasingly being used in some centers, and may potentially be used in higher-risk patients. Question was added to obtain a better understanding for how commonly this mode is being used and how frequently events are detected in patients receiving this kind of mechanical ventilation.

These changes do not affect the estimated burden.

57.118

Denominators for Intensive Care Unit (ICU)/Other Locations (Not NICU or SCA)

No change

  1. Sub-column of number of patients on Airway Pressure Release Ventilation (APRV) was added under ventilator category.

  1. APRV is a mode of mechanical ventilation that is increasingly being used in some centers, and may potentially be used in higher-risk patients. Question was added to obtain a better understanding for how commonly this mode is being used and how frequently events are detected in patients receiving this kind of mechanical ventilation.

This change does not affect the estimated burden.

57.119

Denominator for Outpatient Dialysis

No change

  1. Update header instructions.

  2. Change the wording of “Number of Chronic Hemodialysis Patients” to “Number of Maintenance Hemodialysis Patients”.

  3. Modify wording of “optional fields” to “custom fields”

  1. Headers instructions are being updated for consistency with supporting materials.

  2. Chronic” is being replaced by “maintenance” across NHSN dialysis forms for consistency.

  3. Changing wording to “custom fields” is to match the terminology already in use in the application.

Additionally, due to CMS mandated reporting, the number of respondents increased from 5,500 to 5,700. These changes add 240 burden hours to the ICR.

57.120

Surgical Site Infection (SSI)

No change

No changes

N/A

57.121

Denominator for Procedure

No change

  1. Remove “Implant” field.

  2. Rename “Endoscope” field to “Scope”.

  1. Capturing data on implants has been very difficult and time consuming for data collectors and is subject to considerable variability in interpretation and documentation in the operative note. As a result, the data have not been as useful for risk adjustment as anticipated. Therefore, we plan to eliminate the collection of this variable.

  2. The term “endoscope” has a broader definition than is intended for this data collection. Therefore, we will change the term to “scope” and more clearly define the subset of scopes to be included.

This change decreases burden by 3 minutes per response for an overall decrease of 162,000 burden hours.

57.123

Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables

No change

  1. Edits made to requested variables and form reformatted.

  1. 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

  1. Edits made to requested variables and form reformatted.

  1. Edits were made to the requested variables to accurately reflect changes in the requested data.

This change does not affect the estimated burden.

57.125

Central Line Insertion Practices Adherence Monitoring

No change

No changes

N/A

57.126

MDRO or CDI Infection Form

No change

No changes

N/A

57.127

MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring

No change

No changes

N/A

57.128

Laboratory-identified MDRO or CDI Event

No change

No changes

N/A

57.130

Vaccination Monthly Monitoring Form-Summary Method

No change

No changes

N/A

57.131

Vaccination Monthly Monitoring Form-Patient-Level Method

No change

No changes

N/A

57.133

Patient Vaccination

No change

No changes

N/A

57.137

Long-Term Care Facility Component – Annual Facility Survey

Patient Safety Component-Annual Facility Survey for LTCF

  1. Title change to reflect change in instrument use.

  2. Change in format for collecting data of number of resident by primary service type from annual prevalence to a point prevalence for a single day.

  3. Question regarding C. difficile testing method used has been added.

  4. Several questions with minor editing to enhance clarity of questions asked.

  1. Title change to reflect change in instrument use.

  2. New form for data is easier to collect (now a day point prevalence instead of annual percentage) and enables the ability to distinguish between 0 (service not provide) and 0 (service provided, but no residents in that service type on this day).

  3. For consistency with all other NHSN Annual Facility Surveys C. difficile testing methods has been added. This information is important as it has shown to be significantly associated with C. difficile rates, and thus can be used for facility risk adjustment.

  4. Per user feedback, several questions were edited to enhance clarity.

While these changes do not affect the estimated burden, the time burden was increased from 25 minutes to 45 minutes per feedback from pilot users. This increases the total burden for this form by 83 hours.

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

  1. Increase the number of times the form is filled out from 3 to 12.

  1. The number of times a respondent would fill out this form is increasing due to pilot user feedback.

These changes result in an increase of 188 burden hours.

57.140

Urinary Tract Infection (UTI) for LTCF

No change

  1. Addition of question about presence if indwelling urinary catheter on presentation to facility.

  2. Text edits to questions about presence of, date of insertion, location of insertion of indwelling urinary catheter, and change to format of question about presence of other urinary devices present.

  3. Text edits to Laboratory and Diagnostics check boxes.

  4. Died within 30 days changes to within 7 days.

  5. Transferred to acute care” changed to “Transferred to acute care within 7 days”.

  6. Removed “Date of transfer” question.

  1. Information from pilot of surveillance forms indicated the need for several clarifications of language in the Catheter Status section of this form.

  2. Information from pilot of surveillance forms indicated the need for several clarifications of language in the Catheter Status section of this form.

  3. Information from pilot of surveillance forms indicated the need for clarification to language in the Laboratory and Diagnostics section of this form.

  4. Changes to increase reliability, reduce length of follow-up period, and reduce data collection burden.

  5. Changes to increase reliability, reduce length of follow-up period, and reduce data collection burden.

  6. No longer necessary as preceding question changed to include a seven day follow-up interval.

These changes result in no change of the estimated burden.

57.141

Monthly Reporting Plan for LTCF

No change

No changes

N/A

57.142

Denominators for LTCF Locations

No change

  1. Addition of column for ‘Resident Admissions”.

  1. This data was previously required for surveillance and is obtained from facility administrative databases; however, the prior version of this form had no place to record this information.

This change does not affect the estimated burden.

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

  1. Removal of ‘Managed care organization’ from the facility affiliation section.

  2. Remove the word ‘licensed’ from the description of LTAC intensive care units.

  3. Allow users to specify the version of antimicrobial susceptibility standards used in their microbiology laboratory.

  4. Reword the question for C. difficile testing methods within the facility’s microbiology laboratory.

  1. After review of the data, ‘Managed care organization’ was not a meaningful affiliation type and therefore will be removed from the form.

  2. Further clarification from users demonstrated that not all states license LTAC intensive care unit beds. Therefore, in order to get appropriate counts of LTAC beds, the qualifier of ‘licensed’ needs to be removed.

  3. This change will allow users to more accurately specify the version of antimicrobial susceptibility standards that are used in their lab facilities without needing to update the question on the form and in the application each year when the new version is released.

  4. The clarification of question 13 within the microbiology lab practices section will provide users with a more simplified response and allow for more accurate risk adjustment of this measure.

These changes do not affect the estimated burden of this form.

57.151

Patient Safety Component-Annual Facility Survey for IRF

No change

  1. Removal of ‘Managed care organization’ from the facility affiliation section.

  2. Allow users to specify the version of antimicrobial susceptibility standards used in their microbiology laboratory.

  3. Reword the question for C. difficile testing methods within the facility’s microbiology laboratory.

  1. After review of the data, ‘Managed care organization’ was not a meaningful affiliation type and therefore will be removed from the form.

  2. This change will allow users to more accurately specify the version of antimicrobial susceptibility standards that are used in their lab facilities without needing to update the question on the form and in the application each year when the new version is released.

  3. The clarification of question 13 within the microbiology lab practices section will provide users with a more simplified response and allow for more accurate risk adjustment of this measure.

These changes do not affect the estimated burden of this form.

57.200

Healthcare Personnel Safety Component Annual Facility Survey

No change

  1. Decrease number of respondents from 6,000 to 100.

  1. In the previous OMB submission, Form 57.200 was anticipated to increase in participation with the addition of another module under a CMS mandate within this Component; while the new module will be added, this form will not be a required dependency for users of the new module. The user base required to complete form 57.200 will be considerably lower than previous estimates.

This change decreases the estimated burden of this form by 47,200 hours.

57.202

Healthcare Worker Survey

No change

  1. This form will be removed from the package as it is retired from use.

  1. Due to reevaluation of the Healthcare Personnel Safety Component, it was determined that Form 57.202 be retired from use as it was never built into the NHSN application.

Removing this form decreases the package burden by 10,000 hours.

57.203

Healthcare Personnel Safety Monthly Reporting Plan

No change

  1. Remove ‘Influenza Vaccination with Exposure Management/Treatment’ component from the Healthcare Personnel Vaccination Module section of the form

  2. Remove ‘quarterly’ from the description of the influenza vaccination summary component

  1. The Healthcare Personnel Safety Component is being revised based on the CMS mandate affecting acute care facilities. Therefore, influenza exposure management/treatment will be moved into the Healthcare Personnel Exposure Modules and removed from the vaccination module.

  2. Due to the CMS mandated reporting of influenza vaccination status of healthcare personnel within acute care facilities, this module was revised to be a yearly summary instead of quarterly.

These changes do not affect the estimated burden of this form.

57.204

Healthcare Worker Demographic Data

No change

  1. Decrease number of respondents from 600 to 100.

  1. Based on analysis of current user base using Form 57.204, it is unlikely that the number of respondents will exceed 100.

This change decreases the estimated burden of this form by 33,333 hours.

57.205

Exposure to Blood/Body Fluids

No change

  1. Decrease number of respondents from 600 to 100.

  1. Based on analysis of current user base using Form 57.205, it is unlikely that the number of respondents will exceed 100.

This change decreases the estimated burden of this form by 25,000 hours.

57.206

Healthcare Worker Prophylaxis/Treatment

No change

  1. Decrease number of respondents from 600 to 100.

  2. Increase the number of annual responses from 10 to 30.

  1. Based on the user base, it is estimated that the number of respondents, reduced to 100, is a more accurate reflection of healthcare facilities that use this form.

  2. This form may be filled out more frequently for recording prophylaxis and treatment outcomes than previously estimated.

These changes decrease the burden of this form by 750 hours.

57.207

Follow-Up Laboratory Testing

No change

  1. Decrease number of respondents from 600 to 100.

  2. Decrease the number of annual responses from 100 to 50.

  1. Form 57.207 is required only if NHSN respondents opt for more detailed surveillance post-exposure to a sharp or bite injury, and based on current use of the module, at a maximum it is anticipated that approximately 100 respondents.

  2. Those 100 respondents would complete this form on 50 events per year on average.

These changes decrease the burden of this form by 13,750 hours.

57.208

Healthcare Worker Vaccination History

No change

  1. This form will be removed from the package as it is retired from use.

  1. Due to reevaluation of the Healthcare Personnel Safety Component, it was determined that Form 57.208 be retired from use as it was never built into the NHSN application.

Removing this form decreases the package burden by 30,000 hours.

57.209

Healthcare Worker Influenza Vaccination

No change

  1. This form will be removed from the package as it is retired from use.

  1. Due to reevaluation of the Healthcare Personnel Safety Component, it was determined that Form 57.209 be retired from use.

Removing this form decreases the package burden by 50,000 hours.

57.210

Healthcare Worker Prophylaxis/Treatment-Influenza

No change

No changes

N/A

57.211

Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel

No change

  1. This form will be removed from the package as it is retired from use.

  1. Due to reevaluation of the Healthcare Personnel Safety Component, it was determined that Form 57.211 be retired from use.

Removing this form decreases the package burden by 100 hours.

57.212

Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel

No change

  1. This form will be removed from the package as it is retired from use.

  1. Due to reevaluation of the Healthcare Personnel Safety Component, it was determined that Form 57.212 be retired from use.

Removing this form decreases the package burden by 100 hours.

57.213

Healthcare Personnel Influenza Vaccination Monthly Summary

No change

  1. This form will be removed from the package as it is retired from use.

  1. Due to reevaluation of the Healthcare Personnel Safety Component, it was determined that Form 57.213 be retired from use.

Removing this form decreases the package burden by 72,000 hours.

57.300

Hemovigilance Module Annual Survey

No change

No changes

N/A

57.301

Hemovigilance Module Monthly Reporting Plan

No change

No changes

N/A

57.302

Hemovigilance Module Monthly Incident Summary

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

  1. Remove ‘Unit collection date/time’ data fields within the Component Details table

  1. Per user feedback, this information was too burdensome and not feasible to collect at the unit level.

This change does not affect the estimated burden.

57.305

Hemovigilance Incident

No change

No changes

N/A



NHSN Data Collection Forms: Itemized Revisions and Justifications 19


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorAmy Schneider
File Modified0000-00-00
File Created2021-01-30

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