Clinical Outcomes Data

The AHRQ Safety Program for Healthcare Associated Infection Prevention

Attachment J - Submission Guide for Clinical Outcomes Data Collection

Clinical Outcomes Data

OMB:

Document [docx]
Download: docx | pdf

Shape1

Form Approved
OMB No. 0935-XXXX
Exp. Date XX/XX/20XX

Attachment J: Submission Guide for Clinical Outcomes Data Collection

SUBMISSION GUIDE FOR CLINICAL OUTCOMES DATA COLLECTION


  1. About the Clinical Outcomes Data Collection

The AHRQ Safety Program for Healthcare Associated Infection (HAI) Prevention is collecting unit-level clinical outcomes data to assess hospital-associated infection (HAI) rates across the program. Participating units will either extract clinical outcomes data from their Electronic Health Records (EHRs) and submit via the secure program website OR confer National Healthcare Safety Network (NHSN) data rights to the program group to eliminate data collection burden. See the table below to review the outcomes collected for the program.


Clinical Outcomes Collected

  • Patient Days

  • Device Days

  • Device-Associated Infections – central line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), or ventilator-associated pneumonia/ventilator-associated event (VAP/VAE)


  1. Clinical Outcomes Data Collection and Submission (Retrospective and Quarterly)

Clinical outcomes data will be collected at multiple points during the program. These data are to be collected and submitted for each month of the program on a quarterly basis, as well as submitted for twelve retrospective months. Each month’s data will be entered into a separate form. We strongly recommend designating a specific Data Provider or Coordinator to be responsible for collecting and submitting these data to ensure consistent data collection, along with identifying a backup for these submissions.


We anticipate data collection will take longer for the initial retrospective data pull estimating to take 3.5 hours, and subsequent quarterly data pulls will take 30 minutes per quarter. If your hospital confers NHSN data rights to the program, no submission time is needed as data will automatically be shared.


  1. Clinical Outcomes Definitions and Reporting Instructions

3.1 Patient days - monthly

  • Patient days are defined as a count of the number of patients in a patient care location during a defined time period. This count can be determined electronically or manually by a daily count or, depending on the location type, weekly sampling.

  • As defined using existing Centers for Disease Control and Prevention (CDC), National Healthcare Safety Network (NHSN) definitions (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf

    • Reporting Instructions:

      • Count the number of days that each patient spent in the participating unit during the month for which you are reporting data.

      • For NHSN reporting purposes, the date the patient is admitted to and physically locates to the participating unit is counted as day 1. All days spent in an inpatient unit, regardless of local admission status and/or billing status are included in the counts of inpatient days for the participating location.


3.2 Device days – monthly

  • Device days are defined as a count of the number of patients with a specific device in place in a patient care location during a time period. This count can be determined electronically or manually by a daily count, or weekly sampling.

  • As defined using existing Centers for Disease Control and Prevention (CDC), National Healthcare Safety Network (NHSN) definitions (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf

    • Reporting Instructions:

      • Count how many device days occurred in the participating unit during the month for which you are reporting data.


3.3 Device-Associated Infections – monthly

  • An infection meeting the HAI definition is considered a device-associated HAI (for example, associated with the use of a ventilator, central line, or indwelling urinary catheter) if the device was in place for >2 calendar days on the date of event, and was also in place on the date of event or the day before the event (with date of insertion and date of removal counted as a Device Day). If the device was in place for >2 calendar days and then removed, the date of event must be the day of device discontinuation or the next day to be device associated. For a patient who has a central line in place on hospital admission, day of first inpatient access is considered Device Day 1. For a patient who has a ventilator or indwelling urinary catheter in place prior to inpatient admission, the device day count that determines device–association begins with the admission date to the first inpatient location.

  • As defined using existing Centers for Disease Control and Prevention (CDC), National Healthcare Safety Network (NHSN) definitions (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf

    • Reporting Instructions:

      • Count how many device-associated infections occurred in the participating unit during the month for which you are reporting data.


Central line-associated bloodstream infection (CLABSI) – monthly (CLABSI cohort only)

  • CLABSI is defined as a laboratory confirmed bloodstream infection (LCBI) where an eligible bloodstream infection organism is identified, and an eligible central line is present on the LCBI day of event or the day before. As defined using existing CDC NHSN definitions, Chapter 4 of NHSN Patient Safety Component Manual (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf


Catheter-associated urinary tract infection (CAUTI) – monthly (CAUTI cohort only)

  • CAUTI is defined as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. If an IUC was in place for more than two consecutive days in an inpatient location then removed, the date of event for the UTI must be the day of device discontinuation or the next day for the UTI to be catheter-associated.

  • As defined by Chapter 7 of NHSN Patient Safety Component Manual (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf




Ventilator-Associated Pneumonia (VAP)– monthly (VAP/VAE cohort only)

    • Ventilator-associated pneumonia (VAP) is defined as a pneumonia where the patient is on mechanical ventilation for >2 consecutive calendar days on the date of the event, with the day of the ventilator placement being Day 1 AND the ventilator was in place on the day of the event or the day before. If the ventilator was in place prior to inpatient admission, the ventilator day count begins with the admission date to the first inpatient location. If a break in mechanical ventilation occurs for at least on full calendar day, the ventilator day count for ventilator association starts anew upon reintubation and/or re-initiation of mechanical ventilation.

    • As defined by Chapter 6 of NHSN Patient Safety Component Manual (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf


Ventilator-Associated Event – monthly (VAP/VAE cohort only)

    • A ventilator-associated event (VAE) is identified by using a combination of objective criteria: deterioration in respiratory status after a period of stability or improvement on the ventilator, evidence of infection or inflammation, and laboratory evidence of respiratory infection. Patients must be mechanically ventilated for at least 4 calendar days to fulfill VAE criteria (where the day of intubation and initiation of mechanical ventilation is day 1). The earliest date of event for VAE (the date of onset of worsening oxygenation) is day 3 of mechanical ventilation.

    • As defined by Chapter 10 of NHSN Patient Safety Component Manual (updated January 2025). Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf









File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorYue Gao
File Modified0000-00-00
File Created2025-06-24

© 2025 OMB.report | Privacy Policy