1. Session 7: Reporting and Surveillance of MDROs
Good afternoon, and welcome to Session 5 of today’s conference
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2. MDRO Reporting and Surveillance
In this session, we are going to discuss
CMS and NHSN/CDC reporting
State of Texas reporting of CRE and MDR Acinetobacter
Resources and assistance:
DSHS laboratory services
Healthcare Associated Infection (HAI) team
Local Health Department Contact Info
Surveillance studies
In this session, we will be discussing the following topics [Read slide]
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3. MDRO Reporting and Surveillance
The primary objectives of this session are as follows:
Describe reporting requirements to NHSN
Describe reporting requirements for CRE and MDRA to the state of Texas
In this session, we will be discussing the following topics [Read slide]
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4. Although NHSN considers reporting “voluntary”
Although NHSN considers reporting “voluntary”. Most of you must report something based on CMS or State requirements.
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5.
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6. From HAI reporting update, October 2013
Accessed at
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7. NHSN MDRO Reporting Why report (besides CMS requirements)
To help establish prevalence numbers
National
State
Local
Facility
Lets you know how you compare to other areas
Helps with your risk assessment
From Texas Department of State Health Services Website:
The “unknown” factor is one reason to report. Data collection helps define the problem and track the solutions.
   Texas Trends:
Multi-drug resistant Acinetobacter has been found in Texas. The prevalence of MDR-A is currently unknown. Based on the 2012 Texas Annual Report on Health care-associated Infections Overall Antibiogram, antibiotic sensitivity for Acinetobacter baumannii ranged from 36% susceptible (Imipenem) to 70% Tetracycline.
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8. NHSN MDRO Reporting
Facilities must choose one of two Core reporting options for MDRO and C. difficile (or may choose both)
Laboratory-identified (LabID) events
Infection Surveillance
Facilities may also choose to report on Supplemental Measures
Prevention Process Measures
Hand Hygiene Adherence
Gown and Gloves Use Adherence
Active Surveillance Testing (AST) Adherence
Active Surveillance Testing Outcome Measures
Incident and Prevalent Cases using AST
Based on NHSN requirements, these are voluntary and you can choose how you want to report, but if you fit any of the previous CMS criteria, you must report the LabID events. Per NHSN, facilities can choose one or two of the two CORE reporting options – either Lab ID events or Infection Surveillance (or both, if a facility so chooses). There are also supplemental (optional) measures, including Prevention Process Measures and Active Surveillance Testing Outcome Measures
Multidrug Resistant Organism & Clostridium difficile Infection (MDRO/CDI) Module. January Accessed July 4, 2014
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9. Option 1: MDRO LabID Events
NHSN Core Reporting
Option 1: MDRO LabID Events
MDRO LabID Event Reporting
Facilities can choose to monitor one or more of the following MDROs:
Methicillin-resistant Staphylococcus aureus (MRSA)
MRSA and Methicillin-sensitive Staphylococcus aureus (MSSA)
Vancomycin-resistant Enterococcus spp. (VRE)
Cephalosporin Resistant (CephR)-Klebsiella spp.
Carbapenemase-Resistant Enterobacteriaceae (CRE)-Klebsiella spp.
CRE-Escherichia (E.) coli
MDR Acinetobacter spp.
Within the LabID Core reporting option, facilities can also choose the organism for which they report. These include [read slide]
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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10. Option 1: MDRO Definitions
NHSN Core Reporting
Option 1: MDRO Definitions
Methicillin-resistant Staphylococcus aureus (MRSA)
Includes S. aureus cultured from any specimen that tests oxacillin-resistant, cefoxitin-resistant, or methicillin-resistant by standard susceptiblity testing methods or by a laboratory test that is FDA-approved for MRSA detection from isolated colonies
These methods may also include a positive result by any FDA-approved test for MRSA detection from specific sources
Methicillin-sensitive Staphylococcus aureus (MSSA)
Includes S. aureus cultured from any specimen testing intermediate or susceptible to oxacillin, cefoxitin, or methicillin by standard susceptiblity testing methods, or by a negative result from a test that is FDA-approved for detection from isolated colonies
These methods may also include a positive result from any FDA-approved test for MSSA detection from specific specimen sources
Make sure that you have agreement between your lab and the CDC definition if you are looking at lab ID reporting!
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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11. Option 1: MDRO Definitions
NHSN Core Reporting
Option 1: MDRO Definitions
Vancomycin-resistant Enterococcus spp. (VRE)
Any Enterococcus spp. that is resistant to vancomycin, by standard susceptibility testing methods or by results from any FDA-approved test for VRE detection from specific specimen sources
Cephalosporin Resistant (CephR)-Klebsiella spp.
Any Klebsiella spp. testing non-susceptible (resistant or intermediate) to ceftazidime, cefotaxime, ceftriaxone, or cefepime
[Speaker, highlight content of slide]
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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12. Option 1: MDRO Definitions
NHSN Core Reporting
Option 1: MDRO Definitions
CRE-Ecoli
Any E. coli testing non-susceptible (resistant or intermediate) to imipenem, meropenem, or doripenem, by standard susceptibility testing methods or by a positive result for any method FDA-approved for carbapenemase detection from specific specimen sources
CRE-Klebsiella
Any Klebsiella spp. testing non-susceptible (resistant or intermediate) to imipenem, meropenem, or doripenem, by standard susceptibility testing methods or by a positive result for any method FDA-approved for carbapenemase detection from specific specimen sources
[Speaker, highlight content of slide]
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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13. Option 1: MDRO Definitions
NHSN Core Reporting
Option 1: MDRO Definitions
MDR Acinetobacter
Any Acinetobacter spp. testing non-susceptible (resistant or intermediate) to at least one agent in at least three antimicrobial classes
Beta-lactam/lactamase inhibitor combination
Aminoglycosides
Carbapenems
Fluoroquinolones
Cephalosporins
Sulbactam
Piperacillin
Piperacillin/ tazobactam
Amikacin
Gentamicin
Tobramycin
Imipenem
Meropenem
Doripenem
Ciprofloxacin
Levofloxacin
Cefepime
Ceftazidime
Ampicillin/ sulbactam
[Speaker, highlight content of slide]
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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14. Option 1: Clostridium difficile
NHSN Core Reporting
Option 1: Clostridium difficile
Facilities may choose to monitor C. difficile where testing in the laboratory is performed routinely only on unformed (i.e., conforming to the shape of the container) stool samples
C. Difficile LabID events may be monitored from all available inpatient locations and available affiliated outpatient locations where care is provided to patients post-discharge or prior to admission
C difficile LabID event reporting can occur in any location: inpatient or outpatient
Not NICU, SCN, babies in LDRP, well-baby nurseries, or well-baby clinics
Let’s talk a bit about C diff reporting [speaker, highlight content of slide]
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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15. Option 1: C. diff Definition
NHSN Core Reporting
Option 1: C. diff Definition
CDI positive laboratory assay
A positive lab test result for C. difficile toxin A and/or B (includes molecular assays [PCR] and/or toxin assays) OR
A toxin-producing C. difficile organism detected by culture or other lab means performed on a stool sample
[speaker, highlight content of slide]
CDC. Multidrug Resistant Organisms and Clostridium difficile Infection (MDRO/CDI) Module. January Accessed June 20, 2014
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16. NHSN Core Reporting – CMS rules
To comply with NHSN and CMS reporting requirements, facilities must
map each of their inpatient locations, include MRSA bacteremia and C. difficile LabID events each month
enter LabID events when identified
Enter a summary data record each month
Indicate when they have zero labID events to report
If these requirements are not met, the facility’s data are not sent to CMS
Some notes about LabID CORE reporting: [speaker, highlight content of slide]
Accessed June 25, 2014
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17. Option 2: Infection Surveillance Reporting
NHSN Core Reporting
Option 2: Infection Surveillance Reporting
Surveillance must occur from at least one patient care area and requires active patient-based prospective surveillance of the chosen MDRO(s) and/or C. difficile infections (CDIs) by a trained Infection Preventionist
The IP must seek to confirm and classify infections caused by the chosen organism(s) for monitoring during a patient’s stay in at least one patient care location during the surveillance period
Infection Surveillance can occur in any inpatient location where infections may be identified
Option 1 isn’t really optional, but Option 2 is, so how many of you are reporting this? Numbers would no-doubt be lower if you only had to report MDRO HAIs by CDC definition. Would be interesting for those that report both to show the difference in the numbers between LabID and Infections.
Accessed June 25, 2014
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18. Option 2: Infection Surveillance Reporting
NHSN Core Reporting
Option 2: Infection Surveillance Reporting
Clostridium difficile Infection Surveillance Reporting
Infections from at least one patient care area
Any inpatient location except those with neonatal patients
Any NHSN defined infection in which C. difficile is the pathogen
CDI complications
CDI within 30 days after CDI symptom onset with at least one of the following
Admission to an ICU for complications associated with CDI (e.g., for shock that requires vasopressor therapy)
Surgery (e.g., colectomy) for toxic megacolon, perforation, or refractory colitis
AND/OR
Death caused by CDI within 30 days after symptom onset and occuring during the hospitalization
Just skim headings…no one is probably reporting these and it’s too much information.
Accessed June 25, 2014
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19. NHSN Supplemental Reporting
Prevention Process Measures Surveillance
Monitoring adherence to hand hygiene
Monitoring adherence to gown and glove use as part of contact precautions
Monitoring adherence to Active Surveillance Testing
Active Surveillance Testing Outcome Measures
As mentioned, NHSN also accepts Supplemental Reporting, either PPMS or ASTOM [speaker, highlight content of slide]
Accessed June 25, 2014
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20. NHSN Supplemental Reporting
Active Surveillance Testing Outcome Measures
Definitions
MRSA colonization
Carriage of MRSA without evidence of infection
One of the measures is strictly the presence of colonization of MRSA. How many of you are reporting this?
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Accessed June 25, 2014

21. NHSN Supplemental Reporting
By the way, here is visual showing the percent of people with colonization by body location. As you can see, [point out whichever body locations are of interest to the speaker to highlight]
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Graphic:

22. Movie Quiz
Okay – movie trivia quiz! What movie was this scene in? [answer:bridesmaids]
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23. State of Texas In this section, we will discuss
State and local health department roles, activities, and resources
State reporting requirements
Contacting your local Health Department
Now let’s talk about State roles, activities, resources, and reporting requirements for MDROs
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24. State of Texas
One priority of the State is to prevent and reduce the number of CDIs and MDRO infections along the continuum of patients’ and residents’ healthcare services
This effort requires a multi-disciplinary approach
Community health assessment process, facilities, residents
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25. Texas Public Health System
Role of public health is to bring various groups together, to inform/educate, and facilitate the development of plans to address CDI and MDROs.
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26. Public Health CDI Surveillance
Surveillance systems are vital to monitor trends and inform action
Setting up a system in Texas would require:
Rules update
Additional resources at local and state levels
Standardized definitions for cases and outbreaks
Education and training of public health system work force
Campaign to roll out new requirements to providers
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27. What does the Texas Administrative Code (TAC) say?
Reporting of CR-E. coli, CR-Klebsiella species, MDR-Acinetobacter as defined in the NHSN Manual, Protocol for MDRO/CDI

28. Exceptional Item #9 2014 – 2015 Biennium
Offer free Infection Control Training
Foster a “CDI-prevention” culture
Prevention/response activities evaluated
CDI rates tracked by facility
Share best practices
Leverage expertise of academic centers
University of Houston and the UT Health Science Center at Houston
Texas A & M School of Public Health
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29. Public Health Roles & Responsibilities
Support projects that integrate evidence-based best practices to reduce and eliminate the occurrence of CDI among Texas residents
Oversee implementation of facility-specific action plans to improve infection prevention and control
Encourage organizations to share best practices and engage in discussion on conference calls or at conferences
Support ongoing training programs
Provide technical assistance in epidemiology, analysis, presentation of data, and program evaluation
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30. Reporting Nuts and Bolts
WHAT to Report?
Notifiable conditions
Any outbreaks, exotic diseases, and unusual group expressions of disease
Reported by name, age, sex, race/ethnicity, Date of Birth, address, telephone number, disease, date of onset, method of diagnosis, and name, address, and telephone number of physician
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31. Mandate/Authority
Communicable disease reporting is exempt from HIPAA - Health Insurance Portability and Accountability Act of 1996
Texas Health & Safety Code
Chapter 81: Communicable Diseases
Chapter 98: Reporting of Healthcare-Associated Infections
Texas Administrative Code
Title 25, part 1, Chapter 97 Communicable Diseases
Title 25, part 1, Chapter 96 Bloodborne Pathogen Control
Speaker: No need to read the slide. Just pause and mention there is legislature
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32. Mandate/Authority
80th Legislature enacted Chapter 98 of the Health and Safety Code to require reporting of select HAIs by certain facilities
Clarification provided during the 81st and 82nd legislature on requirements and procedures
Speaker: Do NOT read slide, just comment that Legislature mandates reporting
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33. CRE, MDRA, etc. are notifiable conditions which is a different reporting stream than the NHSN reporting of HAIs.
All sites should be reported, not just “sterile sites”
Look at the footnotes on the Notifiable Conditions list.
CRE:
MDRA:
IMPORTANT NOTE IN THE FOOTNOTES: in addition to specific notifiable conditions, “any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern should be reported” by the most expeditious means available.
Can be found at Instructions
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34. Reporting Nuts and Bolts
WHEN to Report?
Immediately - cases or suspected cases of illness considered to be public health emergencies, outbreaks, exotic diseases, and unusual group expressions of disease
Within one working day - diseases for which there must be a quick public health response
Within one week - all other conditions
HOW to Report?
Most should be reported directly to the Local Health Department or DSHS Health Services Region
Last resort or in case of emergency call the central DSHS office in Austin at
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35. Lab Detection for CRE
Clinical and Laboratory Standards Institute (CLSI) breakpoints for determining carbapenem susceptibility
Breakpoints were lowered to improve detection
Modified Hodge Test (MHT)
Tests for carbapenemase
Not necessary with the recommended lowered breakpoints
Other methods
PCR- only for KPC or NDM
Another reason why the definition may not be helpful is that while the breakpoints maybe clearly defined with break point number, they are not yet used. As stated, the current CRE definition is based on the 2012 Clinical and Laboratory Standards Institute (CLSI). To improve CRE detection, these breakpoints have been lowered several times in the past 5 years, most recently in Using the new breakpoints can help identify patients who should be placed in contact isolation, where with the old criteria the patient may not have been isolated. However, the FDA has not yet approved these new breakpoints, so this means manufacturers cannot update their equipment for hospitals to use these breakpoints (7).
The Modified Hodge Test is a test that can be used to detect carbapenemase production in isolates of Enterobacteriaceae. With the recommended lowered breakpoints the MHT is not necessary, however if a lab is not using the current interpretive criteria/breakpoints then the MHT should be done to confirm an isolate as CRE (7). Not all hospitals are able to perform a MHT due to man power.
You might be asking what about other methods to detect CRE. A polymerase chain reaction (PCR) test can only test for specific carbapenemases, like KPC or NDM. This is not something typically done in a clinical lab and it is not necessary to initiate infection control measures – once the lab ID’s resistance to Carbapenem, appropriate measure should be immediately initiated.
Same MIC value has different interpretations (S, I or R)
CLSI breakpoints
“old” CLSI (2009) breakpoints (M100-S19)
“new” CLSI (2012) breakpoints (M100-S22)
FDA breakpoints
Recommendation:
if using old CLSI breakpoints, do MHT
Lab using commercial systems and automated instruments(Microscan, Vitek, etc.) for AST must use FDA-cleared breakpoints, unless they do their own validation studies for CLSI breakpoints.
FDA has not approved all breakpoints for the CLSI M100-S22.

36. MHT info
To perform the MHT, a suspension of the carbapenem susceptible strain of E. coli ATCC® 25922™* (Microbiologics 0335) is prepared, diluted, and swabbed in lawn-like fashion across a Mueller Hinton plate. A 10 µg meropenem or ertapenem susceptibility disk is placed in the center of the test plate. The test microorganism is streaked in a straight line from the edge of the disk to the edge of the plate. The plate is incubated overnight. A positive test will show growth of the E. coli ATCC® 25922™* on the microorganism streak line towards the carbapenem disk. A negative test will show no growth of the E. coli on the microorganism streak line.
A positive test indicates carbapenemase production by the test microorganism. By producing carbapenemase, the test microorganism is able to inactivate the carbapenem that diffuses from the disk after the disk has been placed on the Mueller Hinton Agar. This allows carbapenem susceptible E. coli ATCC® 25922™* to grow toward the disk. A negative test indicates no carbapenemase production by the test microorganism.
The quality control microorganisms used in the MHT are as follows:
MHT positive Klebsiella pneumoniae, ATCC® BAA-1705™* (Microbiologics 01005)
MHT negative Klebsiella pneumoniae, ATCC® BAA-1706™* (Microbiologics 01006)
Detailed instructions for the MHT can be found in the CLSI book, "Performance Standards for Antimicrobial Susceptibility Testing: Nineteenth Informational Supplement". The procedure is also described by CDC in a pamphlet called, "Modified Hodge Test for Carbapenemase Detection in Enterobacteriaceae".

37. Reporting Carbapenem-Resistant Enterobacteriaceae
Report a suspected or confirmed case immediately by phone to your local health department.
CDC – NHSN MDRO Protocol
E.coli or any Klebsiella spp. testing non-susceptible to imipenem, meropenem or doripenem by standard susceptibility testing methods or
by a positive result for any method FDA-approved for carbapenemase detection from specific specimen sources
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38. Map shows the Texas is not the only state to report CRE
Map shows the Texas is not the only state to report CRE. We actually were state start reporting requirements for CRE.

39. Reporting Carbapenem-Resistant Enterobacteriaceae
When reporting CRE, please include (if available):
a copy of the lab report
carbapenems tested
susceptibility of antibiotics
minimum inhibitory concentration (MIC)
positive phenotypic or PCR test, if applicable.
*A DSHS or local health department epidemiologist may contact you for follow-up after receiving your report. 
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40. Reporting Multi-drug Resistant Acinetobacter
Call immediately to report MDR-A (all species).
Any Acinetobacter species that meet the following criteria should be reported: Nonsusceptible (resistant or intermediate) to at least one antibiotic in at least 3 antimicrobial classes of the 6 listed below
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41. Reporting Multi-drug Resistant Acinetobacter
Please include the following additional information when reporting (if available)
Attach a copy of the lab report
Antibiotics tested
Susceptibility of Antibiotics
Minimum inhibitory concentration (MIC)
*You may be contacted by either a DSHS or local health department epidemiologist after reporting for additional follow-up.
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42. Molecular Subtyping PFGE (Pulsed Field Gel Electrophoresis)
Isolates may be submitted for PFGE with approval of the DSHS MDRO epi.
**DSHS Lab is in process of validation of PCR testing for
drug resistant mechanisms (KPC and NDM)

43. How to Submit?
Contact DSHS MDRO epidemiologist Jessica Ross in the Central Office prior to submission (Phone: )
Make sure to include:
Antimicrobial susceptibility Test (AST) data
MHT data if done
Patient information
Fill out G2B form
Information on DSHS lab website on how to request submission forms
If request for susceptibility or confirmation for susceptibility test, please check “other” under “Section 4, Bacteriology” and write “susceptibility test for CRE +Organism name (Genus and species)”.
If request for PFGE without susceptibility test (confirmed CRE at the submission site), then check “PFGE for” under “Section 6, Molecular Studies” and write CRE+ Genus and species name (i.e. Klebsiella pneumoniae)

44. Contacting your local health department
A list of local health departments is available at the following link:
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45. Surveillance Literature
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46. Surveillance Querying Automated Antibiotic Susceptibility Testing Instruments: A Novel Population-Based Active Surveillance Method for Multidrug-Resistant Gram-Negative Bacilli
In 2010, the CDC’s Emerging Infections Program (EIP) piloted the Multi-Site Resistant Gram-Negative Bacilli Surveillance Initiative (MuGSI) in Georgia and Minnesota
The program was implemented by Georgia EIP staff in three phases
Phase I: Determine local labs’ antibiotic susceptibility testing practices and capabilities for detecting MDR-GNB
Phase II: Pilot surveillance to determine feasibility over the long term and to approximate the proportion of GNB that were MDR
Phase III: Initiate ongoing active surveillance for MDR-GNB in metro Atlanta
The MuGSI study looked at whether the traditional reporting mechanism (lab or IP staff reporting) could be replaced by actually querying the automated instruments.
Reno J et al. Infection Control and Hospital Epidemiology 2014;35(4):
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47. Surveillance Querying Automated Antibiotic Susceptibility Testing Instruments: A Novel Population-Based Active Surveillance Method for Multidrug-Resistant Gram-Negative Bacilli
The initiative showed that laboratory information system outputs typically used for surveillance were not reliable for capturing Clinical and Laboratory Standards Institute breakpoints, but queries developed for three types of automated testing instruments were reliable
Study concluded that directly querying automated testing instruments proved to be a reliable, sustainable, and accurate method of surveillance, compared with a laboratory information system or passive reporting system, and required moderate investment and maintenance
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Reno J et al. Infection Control and Hospital Epidemiology 2014;35(4):

48. Questions and Discussion
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