Reporting

The State Board of Health updated the Virginia Regulations for Disease Reporting and Control (12VAC5-90-80) effective November 14, 2018.  For more information, see letter from the State Health Commissioner.

Carbapenemase-producing organisms

Introduction

Carbapenemase-producing (CP) organisms were added to the reportable disease list and conditions reportable by directors of laboratories.  Thus, the responsibility for reporting the presence of these organisms rests with physicians, directors of medical care facilities, and directors of laboratories.  Because of the special laboratory testing needed to identify and confirm these organisms, however, it is expected that laboratories will be the primary responsible party for reporting these organisms.  A further complexity exists because of the differing levels of capacity for identifying and/or confirming the presence of these organisms in laboratories.  The guidance below is intended to clarify requirements for reporting and for submitting isolates for further public health testing.

Definition

Carbapenemase Producing Organisms (CPO) are defined as organisms where the isolate is:

  • Positive for carbapenemase production by a phenotypic method (e.g., mCIM, Carba NP)

-OR-

  • Positive for a known carbapenemase resistance mechanism by a recognized test (e.g., PCR, X-pert CarbaR)

Reporting

  • Report all carbapenemase-producing organisms, infection or colonization, to your local health department (LHD).
    • Submit a laboratory report and/or Epi-1 form; see Table 1.
    • Include available antimicrobial susceptibility testing (AST) results.
  • Laboratories must submit carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA) isolates to the Division of Consolidated Laboratory Services (DCLS) for further public health testing unless the laboratory is capable of conducting a comparable level of testing for carbapenemase-production as DCLS; see Table 1. This additional testing is not available for other CPOs.

Table 1. Recommendations for Isolate Submission to DCLS and Reporting to LHD Based on Hospital/ Reference Laboratory Testing and Electronic Laboratory Reporting (ELR) Capacity

Laboratory Testing and ELR Capacity Isolate Submission and Reporting 
CRE and CRPA testing capability ELR capacity                   Send CRE and CRPA isolate to DCLS? Reporting Method to LHD for CPO^                                                                                                                                                                                                                                                                                                                  
Unable to perform phenotypic/molecular testing comparable to that conducted by DCLS Yes Yes Not applicable for CP-CRE and CP-CRPA; DCLS reports results to LHD.
All other confirmed CPOs should be reported via ELR.
No Yes Not applicable for CP-CRE and CP-CRPA; DCLS reports results to LHD.
All other confirmed CPOs should be reported via Epi-1 form and/or lab report.
Able to perform comparable phenotypic/molecular testing comparable to that conducted by DCLS+ Yes No* ELR of carbapenemase-production result.
No No* Epi-1 form and/or lab report for carbapenemase-production result.

^ Hospitals using an out-of-state reference laboratory must include these findings in the ELR messages if their laboratory information system is able to do so. If not, submit to public health by fax or mail.
+ Please contact the HAI/AR Program to inquire if your laboratory can be exempt from sending CRE and CRPA isolates for further testing at DCLS.
* Per agreement with Virginia Department of Health, except when requested for further public health testing.

Public Health Laboratory Testing and Response

Laboratory Testing Goals

1. Identify CRE and CRPA isolates that produce a carbapenemase and classify the type of carbapenemase present.

2. Identify early, high-priority results that would require immediate notification to the Centers for Disease Control and Prevention (CDC), and be potentially characterized further at the regional antibiotic resistance laboratory or CDC:

- Pan-resistance
- CP-CRE with resistance mechanism other than Klebsiella pneumoniae carbapenemase (KPC)
- Any CP-CRPA
- mcr-type resistance
- Suspected novel resistance mechanism

3. Facilitate submission of isolates with high-priority results to the regional antibiotic resistance laboratory or CDC for additional testing.

Purpose

The purpose of CRE/CRPA testing conducted by DCLS is to complement, not duplicate, clinical laboratory testing results, as DCLS plays an important public health role in statewide surveillance. The Healthcare-Associated Infections and Antimicrobial Resistance (HAI/AR) Program at the Virginia Department of Health (VDH) recognizes clinical laboratory testing can vary greatly by hospital, and agrees that hospitals conducting phenotypic and molecular CRE and CRPA testing comparable to DCLS do not have to submit isolates to DCLS for duplicative testing. However, the HAI/AR Program, in consultation with DCLS and CDC, requires that clinical microbiology laboratories conducting comparable testing submit results to their local health department in lieu of sending specimens to DCLS.

Please contact the HAI/AR Program to inquire if your laboratory can be exempt from sending CRE and CRPA isolates for further testing at DCLS. 

Testing algorithm conducted at DCLS for Enterobacteriaceae and P. aeruginosa isolates that meet carbapenem AST results requirements (refer to DCLS CRE/CRPA testing instructions)

1. Confirm species identification by MALDI-TOF (Bruker Biotyper)
2. Antimicrobial susceptibility testing (AST) by broth microdilution for all CRE and mCIM-positive CRPA
3. Phenotypic testing for carbapenemase production by modified carbapenem inactivation method (mCIM)
4. Molecular detection of resistance mechanisms (KPC, NDM, OXA-48-like, VIM, IMP, mcr-1 and mcr-2) by real-time PCR for all CRE and mCIM-positive CRPA

Isolate Submission and Reporting Results (refer to DCLS CRE/CRPA testing instructions)

1. Submit pure suspect CRE or CRPA isolates on slant or plate media. Ship isolates at room temperature.
2. Submit a completed DCLS Clinical Microbiology/Virology Request Form and AST results for each isolate. Testing will be delayed if AST results are not received.
3. Turnaround time for reporting results will be within 6 business days of specimen receipt.
4. Alert value results will be verbally reported within 1 working day of results. Non-alert-value, positive results will be verbally reported within 2 working days of results.
5. A hard copy report of final test results will be provided to the submitter by mail.

Public Health Response

Upon confirmation of CP-CRE or CP-CRPA, the local health department will work with the facility/provider to implement the CDC Containment Strategy for Novel or Targeted Multidrug-resistant Organisms by:

1. Identifying transmission is occurring;
2. Identifying affected patients, such as roommates and high risk healthcare contacts;
3. Ensuring appropriate control measures are promptly initiated/implemented to contain potential spread; and
4. Characterizing the organism or resistance mechanism in order to guide additional response actions, patient management, and future responses.

Contact the HAI/AR Program for questions or discussion.

Last Reviewed:  December 2018.  VDH will review this interpretive guidance annually at a minimum, and as needed due to regulation changes.

Candida auris

Candida auris (C. auris) was added to the reportable disease list and conditions reportable by directors of laboratories.  Thus, the responsibility for reporting the presence of these organisms rests with physicians, directors of medical care facilities, and directors of laboratories.

  • Report suspected or confirmed C. auris, infection or colonization, to your local health department.
    • Submit a laboratory report and/or Epi-1 form.
    • Include available antifungal susceptibility testing (AFST) results.
  • Submit isolates to Division of Consolidated Laboratory Services (DCLS) for yeast identification/confirmation using MALDI-TOF (Bruker Biotyper). Note:  Correct identification of C. auris is possible using the MALDI-TOF commercial instruments with C. auris present in the reference profile database (Bruker Biotyper), or by DNA sequencing of the D1/D2 domain.

1. All confirmed C. auris and Candida haemulonii isolates from any specimen source.

OR

2. Yeast isolates from any specimen source when unable to identify species after identification is attempted per laboratory policies.

OR

3. Suspected C. auris isolates from any specimen source. C. auris can be misidentified if your laboratory uses certain yeast identification methods. Isolates identified based on Table 2 should be sent to DCLS for confirmation.

Table 2. Identification Methods for Yeast Isolates

Identification Method Yeast Isolate Identification
bioMérieux Vitek MS MALDI-TOF Candida haemulonii
Vitek 2 YST **
                
Candida haemulonii
Candida duobushaemulonii                             
API 20C Candida sake
Rhodotorula glutinis (red color not present)
BD Phoenix Candida haemulonii
Candida catenulata
MicroScan Candida lusitaniae
Candida guilliermondii
Candida parapsilosis
Candida famata
RapID Yeast Plus Candida parapsilosis

** Vitek 2 software version 8.01 contains identification algorithms for C. auris; however, misidentification has been reported for some clades (e.g., South African and East Asian). It is recommended to send isolates to DCLS for identification/confirmation until more data are available.

  • The following Candida species do not require submission to DCLS for testing:
    • C. albicans
    • C. dubliniensis
    • C. glabrata
    • C. krusei
    • C. tropicalis

 

Public Health Laboratory Testing and Response

Laboratory Testing Goals

1. Identify C. auris isolates.

2. Identify early, high-priority results that would require immediate notification to Centers for Disease Control and Prevention (CDC), and be potentially characterized further at the regional antibiotic resistance laboratory or CDC.

3. Facilitate submission of isolates with high-priority results to the regional antibiotic resistance laboratory or CDC for additional testing.

Testing algorithm conducted at DCLS for Candida auris

  1. Confirm species identification by MALDI-TOF (Bruker Biotyper)
  2. Other public health testing may occur as needed and will be facilitated through the CDC Antimicrobial Resistance Laboratory Network

Isolate Submission and Reporting Results

  1. Pure yeast isolates should be submitted on a Sabouraud Dextrose agar slant or other appropriate media suitable for the growth of yeast. Ship isolates at room temperature.
  2. Submit a completed DCLS Clinical Microbiology/Virology Request Form and AFST results for each isolate.
  3. VDH and the submitter will be contacted when C. auris is identified.

 

Public Health Response

Upon confirmation of Candida auris, the local health department will work with the facility/provider to implement the CDC Containment Strategy for Novel or Targeted Multidrug-resistant Organisms by:

1. Identifying transmission is occurring;
2. Identifying affected patients, such as roommates and high risk healthcare contacts;
3. Ensuring appropriate control measures are promptly initiated/implemented to contain potential spread; and
4. Characterizing the organism in order to guide additional response actions, patient management, and future responses.

Contact the HAI/AR Program for questions or discussion.

Last Reviewed:  December 2018.  VDH will review this interpretive guidance annually at a minimum, and as needed due to regulation changes.

The HAI Annual Report summarizes the performance of Virginia’s acute care hospitals on HAIs and healthcare worker influenza (flu) vaccination. The purpose of the report is to enable readers to view hospital-specific HAI performance, understand Virginia’s HAI performance as a whole, and to compare a hospital’s HAI performance to that of the rest of the country. The consumer report is intended to educate healthcare consumers and leaders on infections that can occur while receiving healthcare and empower patients with information they can use to advocate for safe healthcare. Overall, HAIs are largely preventable, and healthcare providers and consumers can take steps to prevent infections in hospitals and other healthcare settings.

2016 Executive Summary

2016 Virginia Healthcare-Associated Infections Report for a Healthcare Provider Audience

2016 Virginia Healthcare-Associated Infections Report for a Healthcare Consumer Audience 

A Tableau dashboard has been created in order for readers to interact with and better visualize the data in the HAI Annual Report. The dashboard includes 2015 and 2016 data.

Past Reports

For questions or comments, please contact the HAI Epidemiologist at hai@vdh.virginia.gov.

Overview

Healthcare-associated infections (HAIs) can be identified through a variety of methods including observing the patient and reviewing the patient’s medical record including antibiotic orders, healthcare provider notes, microbiology reports, and/or laboratory results.  Healthcare facilities collect data on HAIs using standardized definitions and may share the data with different groups inside (ex. unit staff, Infection Control Committee) and outside the facility (ex. Board of Directors, health department, general public).  Monitoring HAIs allows the facility to detect trends, identify risk factors for infection, guide treatment, assess the impact of their prevention measures, as well as detect potential outbreaks or clusters of illness.

  • HAI data are used for a variety of purposes, which may include satisfying reporting mandates, comparing infection rates between and within healthcare facilities, providing consumers with information, guiding policies and procedures, evaluating the effectiveness of interventions, and conducting research.
  • Surveillance data can be categorized into process measures or outcome measures:

 Process Measures

Outcome Measures

  • Measures a process that may affect/prevent an outcome
    • Less complicated
      • Does not require risk adjustment
      • Usually easier to understand
    • Target rate = 100%
    • Applies to variety of healthcare settings
    • Involves direct care providers ownership / accountability
    • Ex. hand hygiene, Surgical Care Improvement Project (SCIP) measures
  • Measures actual result
    • More complicated
      • Often requires risk adjustment
      • Often more difficult to understand
    • Customized goals can be set
    • May not be able to be collected in all settings
    • May not involve direct care  less ownership/accountability
    • Ex. CLABSI, SSI, CAUTI
  • Infection prevention staff follow standardized definitions to track HAIs; these are surveillance definitions and may be different than clinical definitions, which are used to guide treatment of patients.

Data interpretation / Common HAI measures

  • Infection rate
    • Number of infections divided by the population at risk (denominator), which varies depending on the type of infection
      • Device-associated infections
        • For catheter-associated urinary tract infections (CAUTI), the population at risk is measured in catheter days
        • For central line-associated bloodstream infections (CLABSI), the population at risk is measured in central line days
        • For ventilator-associated pneumonia (VAP), the population at risk is measured in ventilator days
      • Procedure-associated infections
        • For surgical site infections (SSI), the population at risk is measured in surgical procedures
    • Rate usually expressed per 1,000 device days (if device associated) or per 100 procedures (if procedure-associated)
    • Rate may also be expressed per 100 patients/residents to get a percentage of the selected population with a given type of infection. This measure is commonly calculated in long-term care facilities.
      • Example: The percentage of residents with a urinary tract infection (UTI) is calculated by dividing the number of residents in the surveillance area who meet the criteria for a new UTI by the number of residents in the surveillance area for the same time period, and multiplying by 100.
  • Device utilization ratio
    • Number of device-associated infections (i.e. CLABSI, CAUTI, VAP) divided by the number of device days
  • Standardized infection ratio (SIR)
    • A summary measure used to track HAIs at a national, state, or local level over time. Adjusts for patients of varying risk within each facility.
    • SIR compares the observed number of HAIs reported to the predicted (determined from baseline data reported to NHSN)
      • If the SIR <1.0, fewer HAIs were observed than predicted
      • If the SIR = 1.0, the number of HAIs observed were the same as what was predicted
      • If the SIR >1.0, more HAIs were observed than predicted
    • NHSN E-news: Guide to the Standardized Infection Ratio
    • VDH webinar - SIR 101: Interpretation and Public Reporting (April 19, 2012) (presentation) (audio)
    • VDH webinar - SIR 201: Calculating the SIR, Generating Reports, and Presenting the Data (May 3, 2012) (presentation) (audio)
    • VHQC QualitySync conference breakout session – Sir, Can You Please Explain the SIR? (June 13, 2012)(presentation)

Surveillance of Healthcare Worker Influenza Vaccination Rates

As conditions of participation in their quality reporting programs, the Centers for Medicare and Medicaid Services (CMS) requires several types of healthcare facilities to report summary-level healthcare personnel (HCP) influenza vaccination rates to the National Healthcare Safety Network (NHSN). These healthcare settings include:

  • Acute care hospitals (inpatient and outpatient)
  • Long-term acute care hospitals
  • Inpatient rehabilitation facilities
  • Ambulatory surgery centers
  • Outpatient hemodialysis facilities

The NHSN’s Healthcare Personnel Influenza Vaccination Module enables healthcare facilities to record HCP influenza vaccination summary-level data so that HCP influenza vaccination percentages are consistent over time within a single healthcare facility and comparable across facilities and can be used by various types of healthcare facilities. The protocol and instructions, forms, and FAQs for this module can be found here by clicking on the appropriate healthcare setting and selecting the link in the box for healthcare personnel influenza vaccination.

In September 2015, the VDH healthcare-associated infection reporting regulations were updated to align state reporting requirements with the CMS Hospital Inpatient Quality Reporting Program. Under the new regulations, hospitals are reporting healthcare personnel influenza vaccination data to VDH through NHSN for all inpatient healthcare personnel. For more information on these data and the state regulation mandating their reporting, please see the Public Reporting page.

More information on influenza vaccination can be found on the VDH flu vaccination page.


National Healthcare Safety Network (NHSN) and surveillance tools

Targeted Assessment for Prevention (TAP)

  • NHSN - a secure, internet-based surveillance system designed and maintained by the Centers for Disease Control and Prevention (CDC).
    • Surveillance tools for enrolled facilities (CDC) – click on your healthcare setting type to access NHSN protocols and resources specific to that setting (i.e., acute care hospital, ambulatory surgery center, inpatient rehabilitation facility, long-term acute care facility, long-term care facility, or outpatient dialysis facility).
      • Includes tools for numerous infection types (e.g., catheter-associated urinary tract infections, central line-associated bloodstream infections, multidrug-resistant organisms/Clostridium difficile, surgical site infections, ventilator-associated events) as well as healthcare personnel influenza vaccination.
    • Training (CDC)
    • VDH webinars
      • Part 1: What’s New in NHSN for 2016 (webinar) – February 2016 (slides)
      • Part 2: Using the Targeted Assessment for Prevention (TAP) Strategy (webinar) – March 2016 (slides)
      • Part 3: 2016 Annual Training Updates – CLABSI, CAUTI (webinar) – April 2016 (slides)
      • Part 4: 2016 Annual Training Updates – SSI, CDI (webinar) – April 2016 (slides)
      • NHSN Surveillance: What’s New for 2015 (webinar) – December 2014 (slides) (recording)
    • National and State HAI Reports – reports that include both national data and state-specific data for states mandated by state law to report HAIs.

HAI program activities to enhance surveillance

  • From 2012-2013, VDH and VHQC implemented a C. difficile infection prevention collaborative with enrolled acute care and long-term care facilities to conduct surveillance for C. difficile labID events, implement prevention strategies, and share best practices. Collaborative resources available by contacting the VDH HAI Program.
  • Needs assessments
    • Acute care hospitals – surveyed infection preventionists (IPs), quality improvement professionals (QIs), and administrators to describe current HAI surveillance practices, infection prevention staff responsibilities and available resources, education and training needs, organizational culture, and relationships between IPs and QIs.
    • Assisted living facilities and nursing homes - surveyed the infection prevention point of contact to describe facility demographics, infection prevention-related policies and training, current HAI surveillance practices, frequency of different types of infections, education and training needs, inter-facility communication, and the facility’s relationship with the health department and the licensing agency.
  • Surgical site infection (SSI) surveillance pilot project
    • 18 hospitals voluntarily participated in this project, which involved surveillance of coronary artery bypass graft (CABG), hip replacement, or knee replacement surgeries using NHSN to evaluate the feasibility of public reporting of these infections, quantify time requirements for surveillance, and gather lessons to help prepare other facilities in the event of future reporting requirements
    • All about SSIs: Lessons learned from the SSI surveillance pilot, SSI mini grant program, and the data presentation collaborative (Powerpoint presentation)
    • Surgical site infection (SSI) surveillance pilot project, data presentation collaborative, and SSI mini-grant report
  • SSI mini-grant program
    • Conducted in collaboration with the Virginia Hospital & Healthcare Association (VHHA)
    • 22 hospitals applied for and were awarded funds to assist with implementation of the NHSN Procedure-Associated Module in preparation for reporting surgical site infections to the Centers for Medicare and Medicaid Services (CMS) in 2012
      • Funds were used for equipment and services, training and education, consultative and technical assistance, and/or administrative support
    • Surgical site infection (SSI) surveillance pilot project, data presentation collaborative, and SSI mini-grant report
  • Urinary tract infection (UTI) prevention collaborative
    • 12 nursing homes in the Eastern region piloted the collection of UTI data using a standardized form as part of the UTI prevention collaborative
    • UTI data collection forms (Fall 2011)

Public Reporting

Reporting healthcare-associated infections to the public gives consumers access to information about healthcare facilities in their area, but is only one of the pieces of information that a consumer should use to choose a healthcare facility. Consumers should consider the experience of the facility staff, the advice of their physician, and all other factors that are unique to his or her situation, in addition to infection data.  In Virginia, central line-associated bloodstream infection data from acute care hospitals have been shared with the Virginia Department of Health since July 2008.

As of September 2015, the Regulations for Disease Reporting and Control were updated to align state HAI reporting requirements with those of the Centers for Medicare and Medicaid Services (CMS) Hospital Inpatient Quality Reporting Program. The surveillance data from acute care and critical access hospitals is summarized in an annual report, beginning with 2015 data. For more information on the HAI data and to view the reports, please see the HAI Annual Report page.


On March 21, 2005, the Virginia General Assembly approved House Bill 1570 that amended the Code of Virginia (by adding § 32.1-35.1) to make information on selected nosocomial (i.e., healthcare-associated) infections reportable to the Virginia Department of Health (VDH), through the Centers for Disease Control and Prevention (CDC)’s surveillance system, the National Healthcare Safety Network (NHSN). The Code required that the infection data be released to the public upon request and further directed the Board of Health to develop regulations that specify the infections to be reported and the patient populations to be included.

After significant consultation with stakeholders to determine the kind of data that would be both reliable and useful, the Regulations for Disease Reporting and Control were amended to add a section (12VAC5-90-370) related to healthcare-associated infections (HAIs). In Virginia, central line-associated bloodstream infection data from hospital adult intensive (critical) care units have been shared with VDH since July 2008.

On September 25, 2015, the HAI reporting regulations were amended to expand the amount of HAI data that is shared with VDH. The updated regulations align reporting to the state health department with what hospitals are already reporting to the NHSN for the purposes of complying with the Centers for Medicare and Medicaid Services (CMS) Hospital Inpatient Quality Reporting Program. Under the new regulations, measures now part of the state reporting requirements include central line-associated bloodstream infections (CLABSI) in critical care units and select inpatient units; catheter-associated urinary tract infections (CAUTI) in adult and pediatric critical care units, and select inpatient units; surgical site infections following abdominal hysterectomy and colon procedures; methicillin-resistant Staphylococcus aureus bacteremia laboratory-identified events; Clostridium difficile laboratory-identified events; and healthcare personnel influenza vaccination summary data.

HAI Event Applicable Units Reporting Start Date National Baseline
Central line-associated bloodstream infections (CLABSI) Adult, pediatric, and neonatal intensive care units July 2008 (VDH); January 2011 (CMS) 2006-2008
CLABSI Adult and pediatric medical, surgical, and medical/surgical inpatient wards January 2015 2006-2008
Catheter-associated urinary tract infections (CAUTI) Adult and pediatric intensive care units January 2012 2009
CAUTI Adult and pediatric medical, surgical, and medical/surgical inpatient wards January 2015 2009
Surgical site infections (SSIs) following colon procedures Inpatient procedures January 2012 2006-2008
SSIs following abdominal hysterectomy procedures Inpatient procedures January 2012 2006-2008
Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia laboratory-identified events Facility wide inpatients (FacWideIN) including ED, 24-hour observation January 2013 2010-2011
Clostridium difficile (CDI) laboratory-identified events Facility wide inpatients (FacWideIN) including ED, 24-hour observation January 2013 2010-2011
Healthcare personnel influenza vaccination All inpatient healthcare personnel January 2013 N/A

Infection data are aggregated to ensure that no individual patient may be identified. Reports are posted to the VDH website so that hospitals, healthcare providers, consumers, and other interested parties can view the information.

Data collected about HAIs give consumers access to information about healthcare facilities in their area and across the state. The information can help consumers ask physicians and hospital staff informed questions about infection control and prevention practices in the facility. In addition to infection data, consumers should consider many factors when choosing a healthcare facility, such as the experience of the facility staff and the advice of their physician, as well as the facility’s location and environment, patient services and support services.

For more information: