Jan 3, 2021 — protocol, in its entirety, for that particular event, as shown in the For purposes of NHSN surveillance, if an observation patient is

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January 202 National Healthcare Safety Network (NHSN) Patient Safety Component Manual Table of Contents Chapter 1: National Healthcare Safety Network (NHSN) Overview Chapter 2: Identifying Healthcare-associated Infections (HAI) for NHSN Surveillance Chapter 3: Patient Safety Monthly Reporting Plan and Annual Surveys Chapter 4: Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and non- central line-associated Bloodstream Infection) Chapter 5: Central Line Insertion Practices (CLIP) Adherence Monitoring Chapter 6: Pneumonia (Ventilator-associated [VAP] and non-ventilator-associated Pneumonia [PNEU]) Event Chapter 7: Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and non- catheter-associated Urinary Tract Infection [UTI]) and Other Urinary System Infection (USI) Events Chapter 9: Surgical Site Infection (SSI) Event Chapter 10: Ventilator-Associated Event (VAE) Chapter 11: Pediatric Ventilator-Associated Event (pedVAE) Chapter 12: Multidrug-Resistant Organism & Clostridium difficile Infection (MDRO/CDI) Module Chapter 14: Antimicrobial Use and Resistance (AUR) Chapter 15: CDC Locations and Descriptions and Instructions for Mapping Patient Care Locations Chapter 16: General Key terms Chapter 17: CDC/NHSN Surveillance Definitions for Specific Types of Infections Please Note : The NHSN Patient Safety Component Manual is updated annually based on subject matter expert review and user feedback. Over time, certain chapters have been retired or moved to other components. To avoid confusion, the chapters in the PSC manual do not shift to account for these changes; therefore, chapters 8 and 13 are not listed in the Table of Contents or included in this document.

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January 202 2 1 – 1 National Healthcare Safety Network (NHSN) Overview The NHSN is a secure, Internet -based surveillance system that expands and integrates patient and healthcare personnel safety surveillance systems managed by the Division of Healthcare Quality Promotion (DHQP) at the Centers for Disease Control and Prevention. F acilities that participate in certain reporting programs operated by the Centers for Medicare and Medicaid Services (CMS) can do so through use of NHSN. Furthermore , some U.S. states use NHSN as a means for healthcare facilities to submit data on health care -associated infections (HAIs) and transfusion -related adverse events mandated through their specific state legislation. NHSN enables healthcare facilities to collect and use data about HAIs, adherence to clinical practices known to prevent HAIs, the incidence or prevalence of multidrug -resistant organisms within their organizations, trends and coverage of healthcare personnel safety and vaccination, and adverse events related to the transfusion of blood and blood products. The NHSN includes seven components: Patient Safety, Long -term Care Facility , Outpatient Dialysis, Healthcare Personnel Safety, Biovigilance , Outpatient Procedure , and Neonatal (Figure 1). Figure 1: NHSN Components

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January 202 2 NHSN Overview 1 – 2 The Patient Safety Component includes five modules that focus on events associated with medical devices, surgical procedures, antimicrobial agents used during healthcare, and multidrug resistant organisms . Device -associated Module: o Bloodstream Infection (CLABSI Œ Central l ine -associated bloodstream infection) o Central line insertion practices (CLIP) adherence o Urinary Tract Infection (CAUTI Œ Catheter -associated urinary tract infection) o Pediatric Ventilator -associated events (PedVAE) (NICU and pediatric locations only) o Ventilator -associated events (VAE) (adult locations only) o Pneumonia (VAP Œ Ventilator -associated pneumonia) – in pediatric locations (in -plan* or off -plan*), or NICU and adult locations (off -plan* only) Procedure -associated Module: o Surgical Site I nfecti on (SSI) Antimicrobial Use and Resistance Module (AUR) Multidrug -Resistant Organism and Clostridium difficile Infection (MDRO/CDI) Module *Note : fiIn -planfl surveillance means that the facility has committed to following the NHSN surveillance protocol, in its entirety, for that particular event, as shown in the facility™s NHSN monthly reporting plan. fiOff -planfl surveillance is surveillance that is done because a facility has decided to track a particular event for internal use. Data that are entered into NHSN fioff -planfl are not included in NSHN annual reports or other NHSN publications. A facility makes no commitment to follow the NHSN protocol for fioff -planfl events. Further, fioff -planfl data cannot be uploaded into NHSN via Clinical Document Architecture (CDA) and must be manually entered . Instructions and standardized surveillance methods and definitions for each module of the Patient Safety Component are provided in this manual and on the NHSN website (www.cdc.gov/nhsn ). Modules may be used singly or simultaneously. The NHSN Long -term Care Facility Component provides long -term care facilities (LTCFs) with standardized surveillance methods and definitions for four modules: (1) Multidrug resistant organism (MDRO) and Clostridioides difficile Infection (CDI) laboratory -identified (LabID) Events; (2) Urinary Tract Infections (UTI); (3) Prevention Process Measures 4) Coronavirus Infectious Disease (COVID -19). The component is ideal for use by nursing homes, skilled nursing facilities, chronic care facilities, and assisted living and residential care facilities. LTCF surveillance protocols, training materials, data collection forms, instructions, and other supporting materials are provided on the Long -term Care Facility Comp onent website: https://www.cdc.gov/nhsn/ltc/index.html . Outpatient hemodialysis centers have several surveillance options tailored to their patients and setting in the Dialysis Component . The componen t consists of 3 modules: 1) Dialysis Event; (2) Prevention Process Measures; and (3) Dialysis Patient Influenza Vaccination. Facilities that treat hemodialysis outpatients should refer to the Dialysis Component instructions and standardized surveillance m ethods and definitions at www.cdc.gov/nhsn/dialysis/index.html . There are two modules in the Healthcare Personnel Safety (HPS) Component of NHSN: The Healthcare Personnel Exposure Module and the Healthcare Personnel Vaccination Module. The Healthcare Personnel Exposure Module includes: Blood/Body Fluid Exposure Only; Blood/Body Fluid Exposure with

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January 202 2 NHSN Overview 1 – 3 Exposure Management; and Influenza Exposure Management. This module is no longer available for enro llment and should only be used by facilities that have already been reporting Blood/Body Fluid Exposure and Exposure Management data to the system. The Healthcare Personnel Vaccination Module includes: Influenza Vaccination Summary and COVID -19 Vaccination Summary. Data collected in this surveillance system can assist healthcare facilities, health systems, and public health agencies to monitor and report trends in blood/body fluid exposures, to characterize antiviral medication use for exposures to influ enza, and to monitor annual influenza vaccination coverage and weekly COVID -19 vaccination coverage among healthcare personnel. These modules may be used separately or simultaneously. Instructions and standardized surveillance methods and definitions for the Healthcare Personnel Vaccination Module is provided in the NHSN Manual: HPS Component Protocol https://www.cdc.gov/nhsn/pdfs/hps -manual/vaccination/hps -f lu-vaccine -protocol.pdf The NHSN Biovigilance Component , Hemovigilance Module facilitates national surveillance of transfusion -related recipient adverse events. The Hemovigilance Module is designed for transfusion service staff to collect data on annual facility and transfusion service characteristics, individual reports on adverse transfusion reactions, errors or accidents associated with adverse reactions, and monthly counts of transfused or discarded components. The Hemovigilance Module surveillance protocol, training materials, data collection forms, instructions, and other supporting materials are provided on the Hemovigilance Module website: www.cdc.gov/nhsn/acute -care -hos pital/bio -hemo/index.html . The Outpatient Procedure Component (OPC) includes two modules that focus on adverse events associated with surgical procedures performed in Ambulatory Surgery Centers (ASCs). The two modules include Same Day Outcome Measures and Surgical Site I nfections . Same Day Outcome Measures (OPC -SDOM) are a grouping of outpatient care quality indicators that represent a broad range of risks encountered by patients accessing care in various outpatient settings. The four individual outcome measures are: o Patient Burn o Patient Fall o Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant o All -Cause Hospital Transfer/Admission Surgical Site I nfection (OPC -SSI) – SSI surveillance for outpatient operative procedures using the Outpatient Procedure Component (OPC) replaces the use of the Patient Safety Component SSI event chapter for ASCs. The OPC surveillance protocols, training materials, data collection forms, instructions, and other supporting materials a re provided on the Outpatient Procedure Component website: https://www.cdc.gov/nhsn/ambulatory -surgery/index.html . The Neonatal Component includes one module , Late -Onset Sepsis/ Meningi tis (LOS/MEN). This module will track late -onset sepsis and meningitis events in very low birthweight neonates housed in Level II/III, Level III, and Level IV nursery locations. The following events will be tracked in the LOS/MEN module:

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January 202 2 NHSN Overview 1 – 4 Late -Onset Sepsi s Event: In an eligible infant, a recognized pathogen or common commensal identified from one or more blood specimens by a culture or non -culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment. Under this major type of infection, there are two specific types of infection (see below). o NLCBI 1 o NLCBI 2 Meningitis Event: In an eligible infant, a recognized pathogen or common commensal identified from a CSF specimen by a culture or non -culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment. Under this major type of infection, there are two specific types of infection (see below). o NLCM 1 o NLCM 2 The LOS/MEN surveillance protocols, training materials, dat a collection forms, instructions, and other supporting materials are provided on the Neonatal Component website: https://www.cdc.gov/nhsn/neonatal/index.html Surveillance Techniques Some of the options in the following modules require active, patient -based, prospective surveillance of events and their corresponding denominator data by a trained Infection Preventionist (IP) or their designee . This means that the IP shall seek out infections during a patient™s stay by screening a variety of data sources, such as laboratory, pharmacy, admission/discharge/transfer, radiology/imaging, and pathology databases, as well as patient charts, including history and physical exam notes, nurses ™/physicians ™ notes, temperature charts, etc. Others may be trained to screen data sources for these infections, but the IP must make the final determination. Laboratory -based surveillance should not be used alone, unless all possible criteria for identifying an infection are solely determined by laboratory evidence ( for example , LabID event detection in the MDRO/CDI Module). Retrospective chart reviews should be used only when patients are discharged before all information can be gathered. NHSN forms should be used to collect all required data, using the NHSN definitions of each data field. To minimize the IP™s data collection burden, others may be trained to collect the denominator data and process of care data (for example, central line insertion pract ices). Procedure -Associated Module Surgical site infection (SSI) monitoring is offered through this module. SSI surveillance requires active, patient -based, prospective surveillance techniques (see Surveillance Techniques above). To minimize IPs™ workloa d of collecting denominator data, operating room data may be downloaded (see file specifications at https://www.cdc.gov/nhsn/pdfs/ps -analysis -resources/Importing ProcedureData.pdf ) SSI monitoring requires active, patient -based, prospective surveillance. Concurrent and post -discharge surveillance methods should be used to detect SSIs following inpatient operative procedures and post –

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January 202 2 NHSN Overview 1 – 5 discharge surveillance for outpa tient operative procedures. These methods may include 1) direct examination of patients™ wounds during hospitalization, or follow -up visits to either surgery clinics or physicians™ offices, 2) review of medical records or surgery clinic patient records, 3) visits to the ICU and wards; talk with primary care staff 4 ) surgeon surveys by mail or telephone, and 5) patient surveys by mail or telephone (though patients may have a difficult time assessing their infections). Any combination of these methods (or o ther methods identified by the facility) with the capacity to identify all SSIs is acceptable for use; however, NHSN criteria for SSI must be used. See Surgical Site Infection Event (SSI) protocol for additional examples of concurrent and post -discharge su rveillance methods (www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf ). Device -Associated Module Medical instrumentation increases the risk of development of a n HAI and most patients admitted for health care are exposed to some kind of medical device in the course of their treatment. Such d evices include, but are not limited to, vascular and urinary catheters, and ventilators. NHSN enables facilities to monitor infectious complications associated with the use of these devices and to monitor processes related to their use which might increas e infection risk. Specifically, surveillance of central line -associated bloodstream infection (CLABSI), catheter -associated urinary tract infection (CAUTI), ventilator -associated events (VAE and PedVAE ), and/or ventilator -associated pneumonia (VAP) is possible using the NHSN. In addition, central line insertion practices (CLIP) can be monitored to inform facilities of the appropriateness of their processes and how they may relate to HAI development. See Dialysis Component for detailed instructions for Di alysis Event (DE) surveillance of hemodialysis outpatients (www.cdc.gov/nhsn/dialysis/index.html ). Device -associated denominator data should be collected at the same time each day, or by weekly sampling methods in certain locations, for CLABSI , CAUTI , VAE , PedVAE , and VAP surveillance (see the CLABSI , CAUTI , VAE, PedVAE, and PNEU protocols for guidance). When denominator data are available from electronic databases (for example, ventilator days from respiratory therapy), these sources may be used as long as the counts are not substantially different (+/ – 5%) from manually -collect ed counts that have been validated for a minimum of three months. See the respective device -associated event protocols for detailed surveillance instructions. Antimicrobial Use and Resistance (AUR) Module The use of antimicrobial agents has a direct effe ct on antimicrobial resistance patterns of pathogens. The observed increase in multidrug resistance is in part due to inappropriate prescription of, as well as only partial completion of courses of antibiotics. The AUR Module allows facilities to collect information on the amount of antimicrobials that are used for patient care within their systems, as well as to collect data on the prevalence of drug -resistant organisms in their inpatient and outpatient areas. Electronic capture and reporting of microbiology and pharmacy data are the only available options for reporting data into this module. See the Antimicrobial Use and Resistance protocol for detailed surveillance instructi ons.

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January 2022 2-1 Identifying Healthcare-associated Infections (HAI) for NHSN Surveillance To standardize the classification of an infection as present on admission (POA) or a healthcare-associated infection (HAI), the following objective surveillance definitions and guidance are used for NHSN surveillance: Table of Contents General Instructions . 1 Infection Window Period (IWP) .. 3 Infection Window Period Special Considerations . 4 Date of Event (DOE) .. 7 Location of Attribution (LOA) .. 9 Transfer Rule (Exception to Location of Attribution) .. 9 Repeat Infection Timeframe (RIT) .. 11 Secondary BSI Attribution Period (SBAP) 14 Secondary BSI Attribution Period Tables: 16 Pathogen Assignment Guidance .. 18 Appendix: Flo w Diagram for NHSN Event Determination .. 27 The intention of this approach is to align criteria and definitions and decrease subjectivity while maintaining epidemiologic standardization and clinical relevance. A variety of scenarios to include repeat infections of the same type, concurrent infections of differing types, and pathogen assignment in multi- pathogen infections are addressed. See Appendix Flow Diagram for NHSN Event Determinati on. General Instructions 1. The guidance found in this Chapter is not applicable when performing SSI, VAE, PedVAE or LabID surveillance. Infection window period, Date of Event (DOE), Present on admission (POA), Healthcare-associated infection (HAI), and Repeat infection timeframe (RIT), Secondary BSI attribution period (SBAP) definitions as defined in this chapter do not apply to SSI, VAE , PedVAE , or LabID Events ( Table 1 ). Please refer to Chapters 9, 10, 11 and 12 respectively for guidance specific to these event determinations

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January 2022 Identifying Healthcare-associated Infections 2-2 Table 1: Exceptions to application of Chapter 2 See ENDO criteria in Chapter 17: CDC/NHSN Surveillance Definitions for Specific Types of Infections for endocarditis 2. Organisms belonging to the following genera are typically causes of community-associated infections and are rarely or are not known to be causes of healthcare-associated infections. They are excluded and cannot be used to meet any NHSN definition: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis. Additionally, refer to the individual event protocols for pathogen exclusions specific to the event being reported for example, BSI, UTI, PNEU, ENDO, GIT, IAB. 3. If the date of specimen collection is on or after the date of documentation of evidence of consent AND the patient is being supported for organ donation purposes, an event identified using the specimen culture result or microbiologic non-culture based diagnostic test result should not be reported as an HAI. The patient should, however, still be included in device and patient day denominator data collection. 4. Hospice, palliative or comfort care patients are not excluded from NHSN surveillance. 5. Identification of organisms from specimens collected during post-mortem examination (autopsy) are only eligible for use in meeting the CNS/IC (Intracranial) infection definition and the PNEU infection definition using lung tissue specimen obtained by transthoracic or transbronchial biopsy immediately post-mortem. For all other NHSN definitions autopsy specimens/reports are not eligible for use. 6. Infections occurring in newborns with date of event on hospital day 1 or day 2 are considered POA. Those with date of event on day 3 or later are HAI. This excludes viral, parasite and spirochete infections acquired transplacentally (for example but not limited to herpes simplex, toxoplasmosis, rubella, cytomegalovirus, or syphilis) or as a result from passage through the birth canal. Exception: See guidance about non-reporting of CLABSIs with Group B Streptococcus during

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January 2022 Identifying Healthcare-associated Infections 2-3 Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and Non-central line- associated Bloodstream Infection) protocol. 7. Reactivation of a latent infection (for example but not limited to herpes, shingles, syphilis, or tuberculosis) is not considered to be an HAI. 8. For purposes of NHSN surveillance, if an observation patient is admitted to an inpatient location, the patient must be included in all surveillance events designated in the monthly reporting plan and included in patient and device day counts. The patient is being housed, monitored, and cared for in an inpatient location and therefore is at risk for acquisition of an HAI. Infection Window Period The Infection Window Period (IWP) is defined as the 7-days during which all site-specific infection criteria must be met. It includes the collection date of the first positive diagnostic test that is used as an element to meet the site-specific infection criterion, the 3 calendar days before and the 3 calendar days after (Table 2 ). For purposes of defining the Infection Window Period the following examples are considered diagnostic tests: laboratory specimen collection imaging test procedure or exam Table 2: Infection Window Period It is important to use the first diagnostic test that creates an infection window period during which all elements of the criterion can be found. See example below. Example When meeting PNEU definition using the PNU2 criterion, identification of an eligible organism from blood or from a site-specific specimen, and an imaging test may be available. Both the organism identification

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January 2022 Identifying Healthcare-associated Infections 2-4 and the imaging test are diagnostic tests. Use the first diagnostic test for which all elements of the PNU2 criterion occur within the infection window period . In this example below, Option 1 uses the imaging test (not the blood culture) to set the infection window period. This is the first diagnostic test that creates an infection window period in which all elements of PNU2 criterion occur. Infection Window Period Special Considerations 1. Infection criteria that do not include a diagnostic test: For site-specific infection criteria that do not include a diagnostic test , the date of the first documented localized sign or symptom that is used as an element of the site-specific infection criterion is used to define the infection window period for example, diarrhea, site-specific pain, purulent drainage. Note that a non-specific sign or symptom for example, fever is not considered to be localized and therefore is not to be used to define the infection window period.

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