Non-Substantive Change Request Justification 082918

Non-sub change request_2018.doc

Emerging Infections Program

Non-Substantive Change Request Justification 082918

OMB: 0920-0978

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Emerging Infections Programs (EIP)

OMB Control Number 0920-0978

Expiration Date: 05/31/2021




Program Contact


Sonja Mali Nti-Berko

Emerging Infections Programs (EIP)

Division of Preparedness and Emerging Infections

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd, MS-C18

Atlanta, GA 30329

Phone: (404) 488-4780

E-mail: [email protected]



Submission Date: August 23, 2018


Circumstances of Change Request for OMB 0920-0978


This is a nonmaterial/non-substantive change request for OMB No. 0920-0978, expiration date 02/28/2019, for the Emerging Infections Programs (EIP). All requested changes represent minor modifications to already-approved instruments including revised formatting, rewording, new answer options, and the addition/subtraction of a limited number of questions. Larger changes are being packaged together into a revision ICR that will be submitted in winter 2018/2019.


The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions, local health departments, public health and clinical laboratories, infection control professionals, and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases.


Activities of the EIPs fall into the following general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies. Activities of the EIPs are designed to: (1) address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease.


Activities in the EIP Network in which all applicants must participate are:

  • Active Bacterial Core surveillance (ABCs): active population-based laboratory surveillance for invasive bacterial diseases.

  • Foodborne Diseases Active Surveillance Network (FoodNet): active population-based laboratory surveillance to monitor the incidence of select enteric diseases.

  • Influenza Hospitalization Surveillance Network (FluSurv-NET): active population-based surveillance for laboratory confirmed influenza-related hospitalizations.

  • Healthcare-Associated Infections-Community Interface (HAIC) surveillance: active population-based surveillance for healthcare-associated pathogens and infections.


This non-substantive change request is for changes to the disease-specific data elements for ABCs, FluSurv-NET, and HAIC only. As a result of proposed changes, the estimated annualized burden is expected to decrease by 360 hours, from 40,347 to 39,987 and the estimated number of annual responses is shown to decrease by 8,850 from 115,600 to 106,750 responses. The data elements and justifications are described below.


The forms for which approval for changes are being sought include:


ABCs:


  1. 2019 ABCs Case Report Form (Att. 1)

  2. 2019 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form (Att. 2)

  3. 2019 ABCs Neonatal Infection Expanded Tracking Form (Att. 3)

  4. 2019 ABCs Non-Invasive Pneumococcal Pneumonia (SNiPP) (discontinued)



FluSurv-NET:


  1. Influenza Hospitalization Surveillance Network Case Report Form (Att. 4)


HAIC:


  1. 2019 Resistant Gram-Negative Bacilli (MuGSI) Case Report Form for Carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii (Att.5)

  2. 2019 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att.6)

  3. Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Carbapenem-resistant Pseudomonas aeruginosa (CR-PA) (discontinued).

  4. 2019 Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att. 7)

  5. 2019 Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Att. 8)

  6. 2019 CDI Case Report and Treatment Form (Att. 9)

  7. 2019 HAIC Candidemia Case Report (Att. 10)


Description of Changes


ABCs:


  1. 2019 ABCs Case Report Form

There is no impact on burden due to the changes on this form. Changes include:

  1. Question 3 – Added collection of Patient ID, which is a person ID, to be able to link persons with multiple recurrences of invasive bacterial disease.

  2. Questions T1 – T8 – Reformatting method of collection for previous Questions 3a, 3b, 3c, 3d, 12a, 12b, 13, 13b, 14, 15, and 15b to standardize the method of collection with HL7 messaging format for these question as a repeating group.

  3. Question 22a, added an option for ‘Left Against Medical Advice” (AMA) to aid in understanding impact on severity of illness.

  4. Question 27, Underlying Conditions – adding checkbox for ‘HbA1C’ laboratory value and the date the value was collected. This will be collected for diabetic cases only to understand the level of management of the disease (diabetes) which can influence long-term sequelae.

  5. Question 27c, Substance Use – change option ‘E-cigarette’ to ‘E-Nicotine Delivery System’

  6. Question 27d, Substance Use – Added option for Marijuana/cannabinoid use (other than smoking), added checkbox for ‘Documented Use Disorder or Abuse’ for each Substance use category, added ‘Skin popping’ as option for mode of delivery for substance use. Changed ‘Illicit opioid’ to ‘Opioid, DEA schedule I (e.g. heroin)’, ‘Prescription opioid’ to ‘Opioid, DEA Schedule II – IV (e.g., methadone, oxycodone), and changed ‘Stimulant (cocaine, meth, etc.)’ to ‘Cocaine or methamphetamine’. All changes made to better capture information actually documented in the patient’s medical record and to understand the risk associated with substance use for ABCs cases.

  7. Question 28c – adding ‘Medical Chart’ check box better capture the source of where vaccination history information is obtained.


  1. 2019 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form

There is no impact on burden due to the changes on this form. Changes include:

  1. Minor wording changes to instructions at the top of the form on the first page to clarify what information is being collected

  2. Question 29 – added a ‘None listed’ option to better capture this information


  1. 2019 Neonatal Infection Expanded Tracking Form

There is no impact on burden due to the changes on this form. Changes include:

  1. Question 35 will be recoded to harmonize with Question 5 on the ABCs CRF. Two wording changes:

  1. Option 2: “Partial” changed to “Incomplete”.

  2. Option 3 (now changing to option 4): “after 3 requests” added.



  1. 2018 Surveillance for Non-Invasive Pneumococcal Pneumonia (SNiPP)

This form is being removed from the package. Justification: Data collection is limited to only 9 respondents and there is no plan to increase the number of respondents in the foreseeable future. The removal of this form from the EIP ICR results in a decrease in burden of 208 hours per year.

FluSurv-Net:

  1. Influenza Hospitalization Surveillance Network Case Report Form

On 5/22/2018, OMB approved a full revision including minor changes including test types, substance abuse, disease, treatment, and diagnosis. For this change request, proposed revisions include minor revised language and rewording to improve clarity of the data collection form and additional of several variables including minor additional choices for patient residence at time of hospitalization, pregnancy, acute signs/symptoms at admission, bacterial pathogens, and diagnosis. Select questions about date of onset of acute condition leading to hospitalization, treatment, and sign/symptoms were removed. Burden hours have remained unchanged for these changes.

HAIC:



  1. 2019 MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)

For the 2019 Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem Resistant A. baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF), we are proposing the following changes: 1) we are requesting the addition of ten antimicrobial agents to the susceptibility table (three of these antimicrobials were added for harmonization purposes between this CRF and the ESBL CRF, we expect improved consistency will reduce burden among reviewers); 2) we reworded the questions related to carbapenemase testing to streamline data collection and to make data collection more intuitive and more efficient; 3) we added one new question related to CRAB cases; 4) we have changed the language of many of the existing questions so that it is the same for all the population based surveillance activities for HAIC, and we expect that this will add efficiency in completing these questions and reduce burden; 5) we have also reordered the questions based on feedback from the EIP sites, again in an effort to make the completion of the form more efficient and to reduce the time it will take to complete; 6) we have modified the way substance use is collected.

The language changes, listed above, were made in conjunction with all other HAIC pathogen groups to standardize the way questions are asked across all HAIC pathogens. In some instances, this resulted in minor modifications to the question wording and response options, including the order in which the responses are presented. Harmonization efforts have also resulted in moving questions from one section of the CRF to another. In several questions, we have added additional checkboxes; this includes 22 checkboxes in the underlying conditions section. The overall goal of these harmonization efforts is to simplify the form for respondents and to reduce the time it will take to complete the form.



We have modified the way substance use is collected. These data elements were collecting in a more general way, on previously approved HAIC data collection forms. The substance use questions are important to track the impact of the opioid epidemic on the disease burden for MuGSI pathogens. Information on substance use is already collected for other EIP pathogens, outside of the HAIC program.



The requested changes will have minimal impact on the burden of data collection and are anticipated to have a small impact on the time expected to complete the case report form. We are anticipating a 5 minute increase.

  1. 2019 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL)

For the 2019 Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteriaceae Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form (CRF), we are requesting the following changes: 1) the addition of two new questions to better capture information on patients’ urine cultures and history of UTIs; 2) several questions were updated to align with the MuGSI CRE/CRAB CRF to harmonize between the two forms and to reduce the burden on chart abstractors (see detailed description of changes); 3) added questions to align with the MuGSI CRE/CRAB CRF (see detailed descriptions of changes); 4) removed the question 15b from the 2018 ESBL CRF; 6) we reworded the questions related to ESBL detection in clinical microbiology laboratories make the question more intuitive and thus reducing the burden it will take to complete this question, these changes were made as a result of analyzing the pilot ESBL data; 5) we have changed the language of many of the existing questions so that data collection of common questions is standardized across the population based surveillance activities for HAIC, and we expect that this will add efficiency in completing these questions and should reduce burden; 6) we have also reordered the questions based on feedback from the EIP sites, in an effort to make the completion of the form more efficient and to reduce the time it will take to complete the form; 7) we have modified the way substance use is collected.



Harmonization between this CRF and the CRE/CRAB CRF will save time and reduce burden on our chart reviewers that use these forms. The staff that complete this and the CRE/CRAB CRF in the EIP sites are the same.



Additionally, we have changed the language of many existing questions. These changes were made in conjunction with all other HAIC pathogen groups to standardize the way questions are asked across all HAIC pathogens. In some instances, this resulted in minor modifications to the question wording and response options, including the order in which the responses are presented. Harmonization efforts have also resulted in moving questions from one section of the CRF to another. In several questions, we have added additional checkboxes; this includes 22 checkboxes in the underlying conditions section. The overall goal of these harmonization efforts is to simplify the form for respondents and to reduce the time it will take to complete the form.



We have modified the way substance use is collected. These data elements were collected in a more general way, on previously approved HAIC data collection forms. The substance use questions are important to track the impact of the opioid epidemic on the disease burden for ESBL-producing pathogens. Information on substance use is already collected for other EIP pathogens, outside of the HAIC program.



The requested changes will have minimal impact on the burden of data collection and are anticipated to have a small impact on the time expected to complete the case report form. We are anticipating a 5 minute increase.



  1. Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Carbapenem-resistant Pseudomonas aeruginosa (CR-PA)

This form is being removed from the package. The removal of this form from the EIP ICR results in a decrease in burden of 2,580 hours per year. There is no longer a need for EIP to continue collecting data on Carbapenem-resistant Pseudomonas aeruginosa cases. Because of high case counts, sufficient medical record data has been collected.

  1. Invasive MRSA Infection Case Report Form

Changes are being requested for the 2019 Methicillin-resistant Staphylococcus aureus (MRSA) Case Report Form: 1) the addition of susceptibility for two additional antimicrobial agents; 2) we have modified the way substance use is collected; 3) we have changed the language of many of the existing questions so that data collection of common questions is standardized across the population based surveillance activities for HAIC, and we expect that this will add efficiency in completing these questions and should reduce burden; 4) we have reordered the questions based on feedback from the EIP sites in an effort to make the completion of the form more efficient and to reduce the time it will take to complete the form.



We have changed the language of many existing questions. These changes were made in conjunction with all other HAIC pathogen groups to standardize the way questions are asked across all HAIC pathogens. In some instances, this resulted in minor modifications to the question wording and response options, including the order in which the responses are presented. Harmonization efforts have also resulted in moving questions from one section of the CRF to another. In several questions, we have added additional checkboxes; this includes 22 checkboxes in the underlying conditions section. The overall goal of these harmonization efforts is to simplify the form for respondents and to reduce the time it will take to complete the form.



We have modified the way substance use is collected. These data elements were collected in a more general way, on previously approved HAIC data collection forms. The substance use questions are important to track the impact of the opioid epidemic on the disease burden for MRSA. Information on substance use is already collected for other EIP pathogens, outside of the HAIC program.



The requested changes will have minimal impact on the burden of data collection and are anticipated to have a small impact on the time expected to complete the case report form. We are anticipating a 5 minute increase. Additionally, the estimated number of annual responses has been adjusted: from 609 to 474. The net change in burden is a 55 hour decrease.



  1. 2019 Invasive MSSA Infections Case Report Form

The following changes are requested for the 2019 Methicillin-sensitive Staphylococcus aureus (MSSA) Case Report Form: 1) addition of susceptibility for two additional antimicrobial agents; 2) we have modified the way substance use is collected; 3) we have changed the language of many of the existing questions so that data collection of common questions is standardized across the population based surveillance activities for HAIC, and we expect that this will add efficiency in completing these questions and should reduce burden; 4) we have reordered the questions based on feedback from the EIP sites in an effort to make the completion of the form more efficient and to reduce the time it will take to complete the form.



We have changed the language of many existing questions. These changes were made in conjunction with all other HAIC pathogen groups to standardize the way questions are asked across all HAIC pathogens. In some instances, this resulted in minor modifications to the question wording and response options, including the order in which the responses are presented. Harmonization efforts have also resulted in moving questions from one section of the CRF to another. In several questions, we have added additional checkboxes; this includes 22 checkboxes in the underlying conditions section. The overall goal of these harmonization efforts is to simplify the form for respondents and to reduce the time it will take to complete the form.



We have modified the way substance use is collected. These data elements were collected in a more general way, on previously approved HAIC data collection forms. The substance use questions are important to track the impact of the opioid epidemic on the disease burden for MSSA. Information on substance use is already collected for other EIP pathogens, outside of the HAIC program.



The requested changes will have minimal impact on the burden of data collection and are anticipated to have a small impact on the time expected to complete the case report form. We are anticipating a 5 minute increase. Additionally, the estimated number of annual responses has been adjusted: from 1,035 to 754. The net change in burden is a 308 hour decrease.



  1. 2019 CDI Case Report Form and Treatment Form

Changes are requested for the 2019 CDI Case Report Form and Treatment Form: 1) we removed the audit question; 2) we have added a question to track substance use; 3) we have changed the language of many of the existing questions so that data collection of common questions is standardized across the population based surveillance activities for HAIC, and we expect that this will add efficiency in completing these questions and should reduce burden; 4) we have also reordered the questions based on feedback from the EIP sites, again in an effort to make the completion of the form more efficient and to reduce the time it will take to complete the form.



The language changes, listed above, were made in conjunction with all other HAIC pathogen groups to standardize the way questions are asked across all HAIC pathogens. In some instances, this resulted in minor modifications to the question wording and response options, including the order in which the responses are presented. Harmonization efforts have also resulted in moving questions from one section of the CRF to another. The overall goal of these harmonization efforts is to simplify the form for respondents and to reduce the time it will take to complete the form.



We have added a new question to track substance use. The substance use questions are important to track the impact of the opioid epidemic on the disease burden for CDI. Information on substance use is already collected, but in a more general way on previously approved HAIC data collection forms.



The requested changes will have minimal impact on the burden of data collection and are anticipated to have a small impact on the time expected to complete the case report form. We are anticipating a 5 minute increase.



12. 2019 HAIC Candidemia Case Report

For the 2019 Candidemia case report form (CRF), we have added three new questions and deleted two. The changes were made based on feedback from sites about the usefulness of certain questions and the need to capture different data based on the changing epidemiology of candidemia in the United States. we have changed the language of many of the existing questions so that data collection of common questions is standardized across the population based surveillance activities for HAIC, and we expect that this will add efficiency in completing these questions and should reduce burden; 3) we have also reordered the questions based on feedback from the EIP sites, again in an effort to make the completion of the form more efficient and to reduce the time it will take to complete the form; 4) we have modified the way substance use is collected.



The language changes, listed above, were made in conjunction with all other HAIC pathogen groups to standardize the way questions are asked across all HAIC pathogens. In some instances, this resulted in minor modifications to the question wording and response options, including the order in which the responses are presented. Harmonization efforts have also resulted in moving questions from one section of the CRF to another. In several questions, we have added additional. The overall goal of these harmonization efforts is to simplify the form for respondents and to reduce the time it will take to complete the form.



We have modified the way substance use is collected. The substance use questions are important to track the impact of the opioid epidemic on the disease burden for candida. Information on substance use was already collected, this modified question is now harmonized with the other HAIC data collections.

The requested changes will have no impact on the burden of data collection.



Justification for changes: The changes made to the HAIC forms under this non-substantive request will aid in improving surveillance efficiency and data quality to clarify the burden of disease and possible risk factors for disease. This information can be used to inform strategies for preventing disease and negative outcomes. Specifically, changes were made for clarification purposes, to assist data collectors in capturing data in a standardized fashion to improve accuracy.

Cross walk - 2019 form changes

ABCs:



  1. 2019 ABCs Case Report Form

Current Form

Proposed changes


Added 3. Patient I.D.

T1 – Test Type

Options: 1=PCR, 2=Culture, 3=Antigen, 4=Immunohistochemistry, 5=Latex Agglutination, 7=Other, 9=Unknown

3b. Date first positive culture collected

T2 – Date of first positive specimen collection


3c. Date first positive Culture Independent Diagnostic Test (CIDT, e.g. PCR) COLLECTED

3d. Type of CIDT:

Biofire Meningitis Panel

Filmarray BCID

Verigene BCT

Other ________________

Unknown

T3 – Test method (non-culture)

Options: 1=Biofire FilmArray M/E Panel, 2=other, 3=Biofire Filmarray Blood Culture ID (BCID) Panel, 4=Verigene Gram + Blood Culture Test (BCT), 5=Bruker MALDI Biotyper CA System, 6=BD Directigen Meningitis Combo Test Kit, 7=ThermoFisher Wellcogen Bacterial Antigen Rapid, 8=Alere BinaxNOW Antigen Card, 9=Unknown

13. Sterile Sites from which organism isolated:

CSF Blood Peritoneal fluid Bone

Pericardial Fluid Pleural fluid Joint

Muscle/Fascia/Tendon Internal Body Site (specify)______________ Other normally sterile site (specify) ________________

T4 – Site from which organism isolated

Options: 1=Amniotic fluid, 2=Blood, 3=Bone, 4=Brain, 5=CSF, 6=Heart, 7=Other Sterile Site, 8=Joint, 9=unknown, 10=Kidney,

11=Liver, 12=Lung, 13=Lymph node, 14=Middle ear, 15=Muscle/Fascia/Tendon, 16=Ovary, 17=Pancreas, 18=Pericardial Fluid, 19=Peritoneal Fluid, 20=Placenta, 21=Pleural fluid, 22=Respiratory secretion, 23=Sinus, 24=Spleen

25=Sputum, 26=Vitreous, 27=Wound, 28=Unknown

13b. CIDT STERILE SITE FROM WHICH ORGANISM WAS DETECTED: CSF Blood Other, _____________

14. Other sites from which organism isolated:

Wound Amniotic Fluid Placenta

Middle ear Sinus

Q12a. Bacterial Species isolated from any normally sterile site: Neisseria meningitidis Haemophilus influenzae Group B Streptococcus Group A Streptococcus Streptococcus pneumoniae

T5- Bacterial species isolated*:

Options: 1=Neisseria meningitidis, 2=Haemophilus influenzae, 3=Group B Streptococcus, 5=Group A Streptococcus

6=Streptococcus pneumoniae


* For other bacterial pathogens (i.e. non-ABCs) write-in pathogen name

Q12b. Other bacterial species isolated from any normally sterile site: ______________________________

3a. Was a culture performed?

1 □ Yes, Positive 2 □ Yes, Negative 3 □ No

T6 – Test Result

Options: 1=Positive, 0=Negative, 9=Indeterminant

15. Is Isolate available:

Yes No

T7- Isolate/Specimen Available?

Options: 1=Yes, 2=No

15b. If Isolate Not available, why not?

N/A at hospital lab N/A at state lab Hospital refuses Isolate discrepancy (2x) No DNA (non-viable)

T8- If isolate/specimen not available, why not?

Options: 1=N/A at Hospital Lab 2=N/A at State Lab, 3=Hospital refuses, 4=Isolate Discrepancy (2x), 5=No DNA (non-viable)

22a. If survived, patient discharged to:

Home LTC/SNF LTACH Unknown

Other, Specify __________ If discharged to LTC/SNF or LTACH, list Facility ID____________

Added checkbox, ‘Left AMA’

22a. If survived, patient discharged to:

Home LTC/SNF LTACH Left AMA Unknown

Other, Specify __________ If discharged to LTC/SNF or LTACH, list Facility ID____________

27. Underlying causes or prior illnesses

27. Added Checkbox for lab test, HbA1C ___________ % and Date collected ___/___/______

For diabetic patients only

27c. Smoking:

None Unknown Tobacco E-Cigarrettes

Marijuana

Changed ‘E-cigarrete’ option to ‘E-nicotine delivery system’

27c. Smoking:

None Unknown Tobacco E-Nicotine Delivery System Marijuana

27d. Other substance abuse, current

None Unknown

If yes, check all that apply: mode of delivery

Illicit opioid IDU non-IDU Unk

Prescription Opioid IDU non-IDU Unk

Stimulant IDU non-IDU Unk

Other ___________ IDU non-IDU Unk

Unknown Substance IDU non-IDU Unk


Added Documented use disorder option for all substance categories and added skin-popping option for mode of delivery. Also, changed substance categories for ‘illicit opioid’, ‘prescription opioid’, and ‘stimulant’. Added ‘Marijuana/cannabinoid’ substance category.

27d. Other substances

None Unknown

Documented Use disorder mode of delivery

Marijuana/Cannabinoid (other than smoking) DUD or Abuse IDU Skin Popping non-IDU Unk

Opioid, DEA Schedule I DUD or Abuse IDU

Skin Popping non-IDU Unk

Opioid, DEA Schedule II- IV DUD or Abuse IDU

Skin Popping non-IDU Unk

Cocain or methamphetamine DUD or Abuse IDU

Skin Popping non-IDU Unk

Other ___________ DUD or Abuse IDU

Skin Popping non-IDU Unk

Unknown Substance DUD or Abuse IDU

Skin Popping non-IDU Unk

28c. Were records obtained to verify vaccination history? Yes No

If yes, what is the source of the information?

Vaccine Registry Healthcare Provider Other (specify)_____________________

Added ‘Medical chart’ option below

28c. Were records obtained to verify vaccination history?

Yes No

If yes, what is the source of the information?

Medical Chart Vaccine Registry Healthcare Provider Other (specify)_____________________



  1. 2019 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form

Current Form

Proposed Changes

Indicate type of HiNSES case:

Neonatal: infant (sterile isolates only) – complete #1-10, 11-31


Updated instructions at top of form to clarify information to be collected.

Indicate type of HiNSES case:

Neonatal: infant (sterile isolates only) – complete #1-31


Indicate type of HiNSES case:

Other maternal cases (specify)

Fetal death Hi isolated from placenta/amniotic fluid

Stillbirth – complete #1-3, 12-31

Spontaneous abortion – complete #1-2b, 12-18, 28-31



Updated instructions at top of form to clarify information to be collected.

Indicate type of HiNSES case:

Fetal cases (any gestational age –specify isolate/outcome):

Hi from sterile site in stillbirth – complete #1-3, 12-31

Fetal death Hi isolated from placenta/amniotic fluid

Stillbirth – complete #1-3, 12-31

Spontaneous abortion – complete #1-2b, 12-18, 28-31


29. During the intrapartum period or in the week prior to spontaneous abortion did the mother have any of the following symptoms or diagnoses? (check all that apply)


Unknown

Uterine Tenderness

Foul smelling amniotic fluid

Urinary tract infection

Maternal tachycardia (>100 beats/min)

Fetal tachycardia (>160 beats/min)

Intrapartum fever (>,=100.4 F/38 C)

Maternal WBC >20 or 20,000

Added ‘none listed’ option

29. During the intrapartum period or in the week prior to spontaneous abortion did the mother have any of the following symptoms or diagnoses? (check all that apply)


Unknown

None Listed

Uterine Tenderness

Foul smelling amniotic fluid

Urinary tract infection

Maternal tachycardia (>100 beats/min)

Fetal tachycardia (>160 beats/min)

Intrapartum fever (>,=100.4 F/38 C)

Maternal WBC >20 or 20,000



  1. 2019 Neonatal Infection Expanded Tracking Form

Current Form

Proposed Changes

35. Neonatal infection Expanded Form Tracking Status: 1 □ Complete, 2 □ Partial, 2 □ Chart Unavailable, 2 □ Edited & Corrected

Two wording changes: Option 2: “Partial” changed to “Incomplete”, Option 4: “after 3 requests” added

35. Neonatal infection Expanded Form Tracking Status: 1 □ Complete, 2 □ Incomplete, 3 □ Edited & Corrected, 4 □ Chart Unavailable after 3 requests


  1. Non-Invasive Pneumococcal Pneumonia (SNiPP)– Form Discontinued

FluSurv-NET


  1. Influenza Hospitalization Surveillance Network Case Report Form


Question on 2017-18 Form

Question on 2018-19 Form

C14. Where did patient reside at the time of hospitalization?

  • Private Residence

  • Homeless/Shelter

  • Nursing home/Skilled Nursing Facility

  • Alcohol/Drug Abuse Treatment

  • Hospitalized at birth

  • Rehabilitation facility

  • Jail

  • Hospice

  • Assisted living/Residential care

  • LTACH

  • Group home/Retire

  • Mental hospital

  • Unknown

  • Other long term care facility

  • Other, specify

C14. Where did patient reside at the time of hospitalization?

  • Private Residence

  • Home with Services

  • Homeless/Shelter

  • Nursing home/Skilled Nursing Facility

  • Alcohol/Drug Abuse Treatment

  • Hospitalized at birth

  • Rehabilitation facility

  • Corrections facility

  • Hospice

  • Assisted living/Residential care

  • LTACH

  • Group home/Retire

  • Psychiatric facility

  • Unknown

  • Other long term care facility

  • Other, specify

E1. Date of onset of acute condition resulting in current hospitalization



N/A (Question removed)

E11m. Did patient have any of the following pre-existing medical conditions?

If pregnant, specify gestational age in weeks


E10m. Did patient have any of the following pre-existing medical conditions?

  • Total # of pregnancies to date

  • Total # of pregnancies to date that resulted in a live birth

  • Specify total # of fetuses for current pregnancy

  • Specify gestation age in weeks

  • If gestational age in weeks unknown, specify trimester of pregnancy


E2. Acute signs/symptoms present at admission (began or worsened within 2 weeks prior to admission)

  • Altered mental status/confusion

  • Cough*

  • Headache

  • Seizures

  • Wheezing*

  • Chest pain

  • Diarrhea

  • Myalgia/muscle aches

  • Shortness of breath/respiratory distress*

  • Other, non-respiratory

  • Congested/runny nose*

  • Fatigue/weakness

  • Nausea/vomiting

  • Sore throat*

  • Conjunctivitis/pink eye

  • Fever/chills

  • Rash

  • URI/ILI*

  • No signs/symptoms documented


E1. Acute signs/symptoms present at admission (began or worsened within 2 weeks prior to admission)

  • Altered mental status/confusion

  • Cough*

  • Seizures

  • Wheezing*

  • Shortness of breath/respiratory distress*

  • Congested/runny nose*

  • Sore throat*

  • Fever/chills

  • URI/ILI*

  • No signs/symptoms documented


F1a. Number of ICU Admissions: ______



N/A (Question removed)

G3a. If yes, specify pathogen

G3a. If yes, specify pathogen

Aspergillus (fungus)

H1. Was patient tested for any of the following viral respiratory pathogens within 3 days of admission?

H1. Was patient tested for any viral respiratory pathogens within 14 days prior to or within 3 days after admission?

I2b-I4b. Method of Administration:

Oral

Intravenous (IV)

Inhaled

Unknown


N/A (question removed)


I2c. End Date: ________


I2c. End Date: ________

OR Total Duration (days)

I2e-14e. Dose ________

Dose Unknown

N/A (question removed)


I2f-14f: Frequency ______________

Frequency Unknown

N/A (question removed)


K1. Did the patient have any of the following new diagnoses at discharge? (check all that apply)

  • Acute encephalopathy/encephalitis

  • Acute myocardial infarction

  • Acute Myocarditis

  • Acute renal failure

  • Acute respiratory distress syndrome (ARDS)

  • Acute respiratory failure

  • Asthma exacerbation

  • Bacteremia

  • Bronchiolitis

  • Congestive heart failure

  • COPD exacerbation

  • Diabetic Ketoacidosis

  • Guillain-Barre syndrome

  • Hemophagocytic syndrome

  • Reyes syndrome

  • Rhabdomyolysis

  • Pneumonia

  • Sepsis

  • Seizures

  • Stroke (CVA)

  • No discharge summary available

K1. Did the patient have any of the following new diagnoses at discharge? (check all that apply)

  • Acute encephalopathy/encephalitis

  • Acute myocardial infarction

  • Acute Myocarditis

  • Acute renal failure

  • Acute respiratory distress syndrome (ARDS)

  • Acute respiratory failure

  • Asthma exacerbation

  • Bacteremia

  • Bronchiolitis

  • Congestive heart failure

  • COPD exacerbation

  • Diabetic Ketoacidosis

  • Guillain-Barre syndrome

  • Hemophagocytic syndrome

  • Invasive pulmonary aspergillosis

  • Reyes syndrome

  • Rhabdomyolysis

  • Pneumonia

  • Sepsis

  • Seizures

  • Stroke (CVA)

  • No discharge summary available

K3a. If patient was pregnant on admission but not longer pregnant at discharge, indicate pregnancy outcome at discharge.

  • Miscarriage

  • Ill newborn

  • Newborn died

  • Healthy newborn

  • Abortion

  • Unknown

K3a. If patient was pregnant on admission but not longer pregnant at discharge, indicate pregnancy outcome at discharge.

  • Miscarriage (intrauterine death at <22 weeks GA)

  • Stillbirth (intrauterine death at ≥22 weeks GA)

  • Ill newborn

  • Newborn died

  • Healthy newborn

  • Abortion

  • Unknown

K3b. N/A

K3b. If no longer pregnant, indicate date of delivery or end of pregnancy: ______


HAIC


  1. 2019 MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB)

Question on 2018 form

Question on 2019 form

24. Date reported to EIP site:

□□/□□/□□□□

DATE REPORTED TO EIP SITE:

___ ___ - ___ ___ - ___ ___ ___ ___


Title: 2018 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

Title: 2019 Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem Resistant A. baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

4a. LABORATORY ID WHERE CULTURE IDENTIFIED: ____________________________

4a. LABORATORY ID WHERE INCIDENT SPECIMEN IDENTIFIED: __________________________


6. DATE OF BIRTH:

□□/□□/□□□□

5. DATE OF BIRTH:

___ ___ - ___ ___ - ___ ___ ___ ___

7a. AGE:

□□□



6. AGE

____ ____ ____


Days Mos. Years


7b. Is age in day/mo/yr?

Days Mos. Years


8a. Sex:

Male

Female

7. SEX AT BIRTH:

Male Female

Unknown

Check if transgender


8b. ETHNIC ORIGIN:

Hispanic or Latino

Not Hispanic or Latino

Unknown

8a. ETHNIC ORIGIN:

Hispanic or Latino

Not Hispanic or Latino

Unknown

8c. RACE: (Check all that apply)

White

Black or African American

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Unknown


8b. RACE: (Check all that apply)

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Asian

White

Black or African American

Unknown


10a. DATE OF INITIAL CULTURE

□□/□□/□□□□

9. DATE OF INCIDENT SPECIMEN COLLECTION (DISC):

___ ___ - ___ ___ - ___ ___ ___ ___


13a. ORGANISM ISOLATED FROM INITIAL NORMALLY STERILE SITE OR URINE:


Carbapenem-resistant:

Enterobacteriaceae (CRE)

Escherichia coli

Enterobacter cloacae

Enterobacter aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca

A. baumannii (CRAB)


10. ORGANISM:


Carbapenem-resistant:

Enterobacteriaceae (CRE)

Escherichia coli

Enterobacter cloacae

Klebsiella aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca

A. baumannii (CRAB)

14. INITIAL CULTURE SITE:

Blood

CSF

Pleural fluid

Peritoneal fluid

Pericardial fluid

Joint/Synovial fluid

Bone

Urine

Other normally sterile site _____________

11. Incident specimen collection site (check all that apply)

Blood

Bone

CSF

Internal body site (specify): ________

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Urine

Other normally sterile site (specify): ________


10b. LOCATION OF CULTURE COLLECTION:

Hospital Inpatient

ICU

Surgery/OR

Radiology

Other Unit


Emergency Room


Outpatient

Clinic/Doctors Office

Surgery

Other outpatient

Dialysis center


Observational/clinical decision unit

LTCF Facility ID: ____________

LTACH Facility ID: ____________

Autopsy

Unknown


12. LOCATION OF SPECIMEN COLLECTION:

Outpatient

Facility ID:_______

Emergency room

Clinic/Doctor’s office

Dialysis center

Surgery

Observational/clinical decision unit

Other outpatient

Inpatient

Facility ID: ______

ICU

OR

Radiology

Other inpatient

LTCF

Facility ID: ______

LTACH

Facility ID: ______

Autopsy

Other (specify):_______

Unknown

5. Where was the patient located on the 4th calendar day prior to the date of initial culture?

Private residence

LTCF Facility ID:__________

LTACH Facility ID:__________

Homeless

Incarcerated

Hospital inpatient

Was patient transferred from this hospital?

Yes No Unknown

Facility ID: ___________

Other (specify): __________

Unknown


13. WHERE WAS THE PATIENT LOCATED ON THE 3RD CALENDAR DAY BEFORE THE DISC?

Private residence

LTCF

Facility ID: _____

Hospital inpatient

Facility ID: _____

Was patient transferred from this hospital?

Yes No Unknown

LTACH

Facility ID: _____

Homeless

Incarcerated

Other (specify): __________

Unknown




9. WAS PATIENT HOSPITALIZED AT THE TIME OF, OR WITHIN 30 CALENDAR DAYS AFTER, INITIAL CULTURE?

Yes No Unknown


If yes: Date of admission

□□/□□/□□□□


Date of discharge

□□/□□/□□□□

14. WAS THE PATIENT HOSPITALIZED AT THE TIME OF OR IN THE 29 CALENDAR DAYS AFTER THE DISC?

Yes No Unknown


IF YES, DATE OF ADMISSION:


___ ___ - ___ ___ - ___ ___ ___ ___


11a. Was the patient in the ICU in the 7 days prior to their initial culture?

Yes No Unknown


15a. WAS THE PATIENT IN AN ICU IN THE 7 DAYS BEFORE THE DISC?

Yes No Unknown

IF YES, DATE OF ICU ADMISSION:

___ ___ - ___ ___ - ___ ___ ___ ___ OR □ Date unknown


11b. Was the patient in the ICU on the date of or in the 7 days after the initial culture?

Yes No Unknown


15b. WAS THE PATIENT IN AN ICU ON THE DAY OF INCIDENT SPECIMEN COLLECTION OR IN THE 6 DAYS AFTER THE DISC?

Yes No Unknown

IF YES, DATE OF ICU ADMISSION:

___ ___ - ___ ___ - ___ ___ ___ ___ OR □ Date unknown


12. PATIENT OUTCOME:

Survived

Died

Unknown


If survived, transferred to:

Private residence

LTCF Facility ID:_____

LTACH Facility ID:____

Unknown

Other (specify):_______


If died, date of death:

□□/□□/□□□□

Was the organism cultured from a normally sterile site or urine, ≤ calendar day 7 before death?


Yes No Unknown


16. PATIENT OUTCOME:


Survived

Date of discharge: ___ ___ - ___ ___ - ___ ___ ___ ___ OR

Date unknown

Left against medical advice (AMA)


If survived, discharged to:

Private residence

Other

LTCF Facility ID:_____

(specify):________

LTACH Facility ID:____

Unknown



Died

Date of death: ___ ___ - ___ ___ - ___ ___ ___ ___

ON THE DAY OF OR IN THE 6 CALENDAR DAYS BEFORE DEATH, WAS THE PATHOGEN OF INTEREST ISOLATED FROM A SITE THAT MEETS THE CASE DEFINITION?

Yes No Unknown


19. TYPES OF INFECTION ASSOCIATED WITH CULTURE(S) (check all that apply):

  • None

  • Unknown

  • Abscess, not skin

  • AV fistula/graft infection

  • Bacteremia

  • Bursitis

  • Catheter site infection (CVC)

  • Cellulitis

  • Chronic ulcer/wound (not decubitus)

  • Decubitus/pressure ulcer

  • Empyema

  • Endocarditis

  • Epidural Abscess

  • Meningitis

  • Osteomyelitis

  • Peritonitis

  • Pneumonia

  • Pyelonephritis

  • Septic arthritis

  • Septic emboli

  • Septic shock

  • Skin abscess

  • Surgical incision infection

  • Surgical site infection (internal)

  • Traumatic wound

  • Urinary tract infection

  • Other ___________________

17. TYPES OF INFECTION ASSOCIATED WITH CULTURE(S): (Check all that apply)

None

Unknown

Abscess, not skin

AV fistula/graft infection

Bacteremia

Bursitis

Catheter site infection (CVC)

Cellulitis

Chronic ulcer/wound (not decubitus)

Decubitus/pressure ulcer

Empyema

Endocarditis

Epidural Abscess

Meningitis

Osteomyelitis

Peritonitis

Pneumonia

Pyelonephritis

Septic arthritis

Septic emboli

Septic shock

Skin abscess

Surgical incision infection

Surgical site infection (internal)

Traumatic wound

Urinary tract infection

Other (specify): ____________


20. UNDERLYING CONDITIONS (check all that apply):

None

Unknown

  • AIDS/CD4 count < 200

  • Alcohol abuse

  • Chronic Liver Disease

  • Chronic Pulmonary Disease

  • Chronic Renal Insufficiency

  • Chronic Skin Breakdown

  • Congestive Heart Failure

  • Connective Tissue Disease

  • Current Smoker

  • CVA/Stroke

  • Cystic Fibrosis

  • Decubitus/Pressure Ulcer

  • Dementia/Chronic Cognitive Deficit

  • Diabetes

  • Hemiplegia/Paraplegia

  • HIV

  • Hematologic Malignancy

  • IVDU

  • Liver failure

  • Metastatic Solid Tumor

  • Myocardial Infarct

  • Neurological Problems

  • Obesity or Morbid Obesity

  • Peptic Ulcer Disease

  • Peripheral Vascular Disease (PVD)

  • Premature Birth

  • Solid Tumor (non metastatic)

  • Spina bifida

  • Transplant Recipient

  • Urinary Tract Problems/Abnormalities

18. UNDERLYING CONDITIONS: (Check all that apply)

None

 Unknown

CHRONIC LUNG DISEASE

Cystic fibrosis

Chronic pulmonary disease

CHRONIC METABOLIC DISEASE

Diabetes mellitus

with chronic complications

CARDIOVASCULAR DISEASE

CVA/Stroke/TIA

Congenital heart disease

Congestive heart failure

Myocardial infarction

Peripheral vascular disease (PVD)

GASTROINTESTINAL DISEASE

Diverticular disease

Inflammatory Bowel disease

Peptic ulcer disease

Short gut syndrome

IMMUNOCOMPROMISED CONDITION

HIV infection

AIDS/CD4 count <200

Primary immunodeficiency

Transplant, hematopoietic stem cell

Transplant, solid organ

LIVER DISEASE

Chronic liver disease

Ascites

Cirrhosis

Hepatic encephalopathy

Variceal bleeding

Hepatitis C

Treated, in SVR

Current, chronic

MALIGNANCY

Malignancy, hematologic

Malignancy, solid organ (non-metastatic)

Malignancy, solid organ (metastatic)

NEUROLOGIC CONDITION

Cerebral palsy

Chronic cognitive deficit

Dementia

Epilepsy/seizure/ seizure disorder

Multiple sclerosis

Neuropathy

Parkinson’s Disease

Other specify:_____

PLEGIAS/PARALYSIS

Hemiplegia

Paraplegia

Quadriplegia

RENAL DISEASE

Chronic kidney disease

Lowest serum creatinine:____mg/Dl

SKIN CONDITION

Burn

Decubitus/pressure ulcer

Surgical wound

Other chronic ulcer or chronic wound

OTHER

Connective tissue disease

Obesity or morbid obesity

Pregnant

MuGSI CONDITIONS

Urinary tract problems/abnormalities

Premature birth

Spina bifida



20. UNDERLYING CONDITIONS (check all that apply):

None

Unknown

  • AIDS/CD4 count < 200

  • Alcohol abuse

  • Chronic Liver Disease

  • Chronic Pulmonary Disease

  • Chronic Renal Insufficiency

  • Chronic Skin Breakdown

  • Congestive Heart Failure

  • Connective Tissue Disease

  • Current Smoker

  • CVA/Stroke

  • Cystic Fibrosis

  • Decubitus/Pressure Ulcer

  • Dementia/Chronic Cognitive Deficit

  • Diabetes

  • Hemiplegia/Paraplegia

  • HIV

  • Hematologic Malignancy

  • IVDU

  • Liver failure

  • Metastatic Solid Tumor

  • Myocardial Infarct

  • Neurological Problems

  • Obesity or Morbid Obesity

  • Peptic Ulcer Disease

  • Peripheral Vascular Disease (PVD)

  • Premature Birth

  • Solid Tumor (non metastatic)

  • Spina bifida

  • Transplant Recipient

  • Urinary Tract Problems/Abnormalities

19. SUBSTANCE USE, CURRENT


SMOKING (Check all that apply):

None

Unknown

Tobacco

E-nicotine delivery system

Marijuana


ALCOHOL ABUSE:

Yes

No

Unknown


OTHER SUBSTANCES: (Check all that apply)


None


Unknown

DOCUMENTED USE

DISORDER (DUD)/ABUSE: MODE OF DELIVERY: (Check all that apply)


Marijuana/cannabinoid (other than smoking) □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Opioid, DEA schedule I (e.g., heroin) □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Opioid, DEA schedule II-IV (e.g., methadone, oxycodone) □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Cocaine or methamphetamine □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Other (specify): ___________ □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Unknown substance □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown




Some of the data in this section was formerly collected in the underlying conditions section (IVDU [changed to injection drug user], Current smoker [changed to smoking], Alcohol Abuse (see highlighted conditions in the prior column). The collection of more information for other drug use is new.

There are six new check boxes that allow other drug use to be captured in more detail. These questions focus on type of drug and mode of delivery.


21. RISK FACTORS OF INTEREST (check all that apply):


None

Unknown


Culture collected ≥ calendar day 3 after hospital admission


Hospitalized within year before date of initial culture:

If yes, enter mo/yr □□/□□□□

OR Unknown

If known, prior hospital ID:_________________


Surgery within year before date of initial culture


Current chronic dialysis:

Hemodialysis □ Peritoneal □ Unknown

Hemodialysis Access:

AV fistula/graft □ CVC □ Unknown


Residence in LTCF within year before date of initial culture If known,

facility ID: ______________________


Admitted to a LTACH within year before initial culture date

If known, facility ID: ______________________


Central venous catheter in place on the day of culture (up to time of culture) or at

any time in the 2 calendar days prior to the date of culture


Urinary catheter in place on the day of culture (up to time of culture) or at any

time in the 2 calendar days prior to the date of culture

If checked, indicate all that apply:

Indwelling Urethral Catheter

Suprapubic Catheter

Condom Catheter

Other: _____________


Any OTHER indwelling device in place on the day of culture (up to time of culture)

or at any time in the 2 calendar days prior to the date of culture

If checked, indicate all that apply:

ET/NT Tube

Gastrostomy Tube

NG Tube

Tracheostomy

Nephrostomy Tube

Other: _____________


Patient traveled internationally in the two months prior to the date of initial culture.


Country:__________________, ___________________, __________________


Patient was hospitalized while visiting country(ies) listed above


20. RISK FACTORS: (Check all that apply)


None

Unknown


WAS INCIDENT SPECIMEN COLLECTED 3 OR MORE CALENDAR DAYS AFTER HOSPITAL ADMISSION?

Yes No (please note, this field is auto calculated in the data management system (DMS), therefore, the user does not ever complete this filed and there is not burden associated with its collection. It is on the paper form because our users want to continue to view this in the DMS)


Previous hospitalization in the year before DISC

Yes No Unknown

If yes, date of discharge closed to DISC:

___ ___ - ___ ___ - ___ ___ ___ ___

Facility ID: ___________

OR, Date Unknown


Overnight stay in LTCF in the year before DISC

Yes No Unknown

Facility ID: ___________


Overnight stay in LTACH in the year before DISC

Yes No Unknown

Facility ID: ___________


Surgery in the year before DISC

Yes No Unknown


CURRENT CHRONIC DIALYSIS:

IF YES, TYPE:

Hemodialysis □ Peritoneal □ Unknown

IF HEMODIALYSIS, TYPE OF VASCULAR ACCESS:

AV fistula/graft □ Hemodialysis central line □ Unknown


CENTRAL LINE IN PLACE ON THE DISC (UP TO THE TIME OF COLLECTION), OR AT ANY TIME IN THE 2 CALENDAR DAYS BEFORE DISC:

Yes No Unknown

Check here if central line in place for > 2 calendar days: □


URINARY CATHETER IN PLACE ON THE DISC (UP TO THE TIME OF COLLECTION), OR AT ANY TIME IN THE 2 CALENDAR DAYS BEFORE DISC:

Yes No Unknown

IF YES, CHECK ALL THAT APPLY:

Indwelling Urethral Catheter

Suprapubic Catheter

Condom Catheter

Other (specify):__________


ANY OTHER INDWELLING DEVICE IN PLACE ON THE DISC (UP TO THE TIME OF COLLECTION), OR AT ANY TIME IN THE 2 CALENDAR DAYS BEFORE DISC:

Yes No Unknown

IF YES, CHECK ALL THAT APPLY:

ET/NT Tube □ Gastrostomy Tube □ NG Tube

Tracheostomy □ Nephrostomy Tube □ Other (specify):_____


PATIENT TRAVELED INTERNATIONALLY IN THE YEAR BEFORE DISC:

Yes No Unknown

COUNTRY: ______, ______, ______


PATIENT HOSPITALIZED WHILE VISITING COUNTRY(IES) ABOVE:

Yes No Unknown


8d. WEIGHT:

______lbs ______oz OR ______kg

Unknown

21a. WEIGHT:

_________lbs. ______ oz. OR

_____kg □ Unknown

8e. HEIGHT:

______ft ______in OR ______cm

Unknown

21b. HEIGHT:

_________ft. _______ in. OR

_____cm □ Unknown

8f. BMI (Record only if ht and/or wt is not available):

___________________________

Unknown

21c. BMI:

_________

Unknown

URINE Cultures ONLY:

14a. Was the urine collected through an

indwelling urethral catheter?

Yes No Unknown

URINE CULTURES ONLY:

22a. WAS THE URINE COLLECTED THROUGH AN INDWELLING URETHRAL CATHETER?

Yes No Unknown

URINE Cultures ONLY:

14b. Record the colony count

_________________________


URINE CULTURES ONLY:

22b. RECORD THE COLONY COUNT: ________________

URINE Cultures ONLY:

14c. Signs and Symptoms associated with urine culture.

Please indicate if any of the following symptoms where reported during the 5 day time period

including the 2 calendar days before through the 2 calendar days after the date of initial culture.

Then go to question 14d.

None

Costovertebral angle pain or tenderness

Dysuria

Fever [temperature ≥ 100.4 °F (38 °C)]

Unknown

Frequency

Suprapubic tenderness

Urgency


Symptoms for patients ≤ 1 year of age only:

Apnea

Bradycardia

Lethargy

Vomiting


URINE CULTURES ONLY:

22c. SIGNS AND SYMPTOMS ASSOCIATED WITH URINE CULTURE

Please indicate if any of the following symptoms where reported during the 5 day time period including the 2 calendar days before through the 2 calendar days after the DISC.

None

Costovertebral angle pain or tenderness

Dysuria

Fever [temperature ≥ 100.4 °F (38 °C)]

Unknown

Frequency

Suprapubic tenderness

Urgency


Symptoms for patients ≤ 1 year of age only:

Apnea

Bradycardia

Lethargy

Vomiting

URINE Cultures ONLY:

14d. Was a blood culture positive in the

3 calendar days before through the 3 calendar

days after the initial urine culture for the same

MuGSI organism?

Yes No Unknown

URINE CULTURES ONLY:

22d. WAS A BLOOD CULTURE POSITIVE IN THE 3 CALENDAR DAYS BEFORE THROUGH THE 3 CALENDAR DAYS AFTER THE DISC FOR THE SAME MuGSI ORGANISM?

Yes No Unknown

13b. Was the initial culture polymicrobial?


Yes No Unknown

23. WAS THE INCIDENT SPECIMEN POLYMICROBIAL?

Yes No Unknown

13c. Was the initial

isolate tested for

carbapenemase?


Yes No Laboratory not testing

Unknown


If yes, what testing method was used

(check all that apply):

Automated Molecular Assay

(specify): _________________

CarbaNP

PCR

E Test

Modified Hodge Test (MHT)

Other (specify):____________

Unknown


If tested, what was

the testing result?

Positive

Negative

Indeterminate

Unknown


24a. WAS THE INCIDENT SPECIMEN TESTED FOR CARBAPENEMASE?

Yes No Laboratory not testing Unknown

24b. IF YES, WHAT TESTING METHOD WAS USED? (Check all that apply):

Non-Molecular Tests

CarbaNP

Carbapenemase Incactivation Method (CIM)

Disk Diffusion/ROSCO Disk

E-test

Modified Carbapenemase Incactivation Method (mCIM)

Modified Hodge Test (MHT)

RAPIDEC

Other (specify):_____________

Unknown


Molecular Tests

Automated Molecular Assay

Carba-R

Check Points

MALDI-TOF MS

Next Generation Nucleic Acid Sequencing

PCR

Other (specify):_____________

Unknown

24c. IF TESTED, WHAT WAS THE TESTING RESULT?

Non-Molecular Test Results:

Positive

Negative

Indeterminate

Unknown

Molecular Test Results:

NDM

Pos

Neg

Ind

Unk

KPC

Pos

Neg

Ind

Unk

OXA

Pos

Neg

Ind

Unk

OXA-48

Pos

Neg

Ind

Unk

VIM

Pos

Neg

Ind

Unk

IMP

Pos

Neg

Ind

Unk


15. Was the same organism (Q13a) cultured from a different sterile site or urine in the 30 days after the date of initial culture (of this current episode)?

Yes No Unknown

IF YES, SOURCE: (check all that apply)

Blood

CSF

Pleural fluid

Pericardial fluid

Peritoneal fluid

Joint/Synovial fluid

Bone

Urine

Other normally sterile site__________


25. WAS THE SAME ORGANISM (Q10) CULTURED FROM A DIFFERENT STERILE SITE OR URINE IN THE 30 DAYS AFTER THE DISC?

Yes No Unknown

IF YES, SOURCE: (check all that apply)

Blood

Bone

CSF

Internal body site (specify): ________

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Urine

Other normally sterile site (specify): ________


16. Enterobacteriaceae ONLY:

Were cultures of sterile site(s) or urine positive in the 30 days prior to the date of

initial culture, for a DIFFERENT organism (Q13a)?

Yes No Unknown N/A

IF YES, SOURCE: (check all that apply)

Blood

CSF

Pleural fluid

Pericardial fluid

Peritoneal fluid

Joint/Synovial fluid

Bone

Urine

Other normally sterile site__________


If yes, indicate organism type and associated State ID for the incident closest

to the date of initial culture:


Organism

State ID

Escherichia coli


Enterobacter cloacae


Enterobacter aerogenes


Klebsiella pneumoniae


Klebsiella oxytoca



26. ENTEROBACTERIACEAE ONLY: WERE CULTURES OF STERILE SITE(S) OR URINE POSITIVE IN THE 30 DAYS BEFORE THE DISC, FOR A DIFFERENT ORGANISM (Q10)?

Yes No Unknown N/A

IF YES, SOURCE: (check all that apply)

Blood

Bone

CSF

Internal body site (specify): ________

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Urine

Other normally sterile site (specify): ________


IF YES, INDICATE ORGANISM TYPE AND ASSOCIATED STATE ID FOR THE INCIDENT CLOSEST TO THE DISC:

Organism

State ID

Escherichia coli


Enterobacter cloacae


Klebsiella aerogenes


Klebsiella pneumoniae


Klebsiella oxytoca




16a. A. baumannii Cultures ONLY:

Were cultures of OTHER sterile site(s) or urine positive in the 30 days prior to the

date of initial culture, for another A. baumannii?


Yes No Unknown N/A


Yes No Unknown N/A

IF YES, SOURCE: (check all that apply)

Blood

CSF

Pleural fluid

Pericardial fluid

Peritoneal fluid

Joint/Synovial fluid

Bone

Urine

Other normally sterile site__________


If yes, State ID for the organism

closest to the date of initial culture: ______________


27a. A. BAUMANNII CULTURES ONLY:

WERE CULTURES OF OTHER STERILE SITE(S) OR URINE POSITIVE IN THE 30 DAYS BEFORE THE DISC, FOR ANOTHER A. BAUMANNII?


Yes No Unknown N/A

IF YES, SOURCE: (check all that apply)

Blood

Bone

CSF

Internal body site (specify): ________

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Urine

Other normally sterile site (specify): ________


IF YES, STATE ID FOR THE INCIDENT CLOSEST TO THE DISC: ________________

16b. A. baumannii Cultures ONLY:

Did the patient have a sputum culture positive for CRAB in the 30 days

prior to the date of culture (Day 1)?


Yes No Unknown N/A


27b. A. BAUMANNII CULTURES ONLY:

DID THE PATIENT HAVE A SPUTUM CULTURE POSITIVE FOR CRAB IN THE 30 DAYS BEFORE THE DISC?

Yes No Unknown N/A



27c. A. BAUMANNII CULTURES ONLY:

RISK FACTORS IN THE 7 DAYS BEFORE THE DISC:

Non-invasive positive pressure ventilation (CPAP or BiPAP) at any time in the 7 calendar days before the DISC

Nebulizer treatment at any time in the 7 calendar days before the DISC

Mechanical ventilation at any time in the 7 calendar days before the DISC


17a. Was this patient positive for the SAME organism in the year prior to the date

of the initial culture (Q10a):


Yes No (GO TO Q17c) Unknown (GO TO Q17c)


28a. WAS THE PATIENT POSITIVE FOR THE SAME ORGANISM IN THE YEAR BEFORE THE DISC?


Yes No Unknown


17b. If yes, specify date of culture and State ID for the first positive culture in the year prior:


□□/□□/□□□□

State ID:________________________


28b. IF YES, SPECIFY DATE OF CULTURE AND STATE ID FOR THE FIRST POSITIVE CULTURE IN THE YEAR BEFORE:


DATE OF CULTURE: ___ ___ - ___ ___ - ___ ___ ___ ___

STATE ID:_____________________


17c. Enterobacteriaceae ONLY:

Was this patient positive for a MuGSI Enterobacteriaceae in the year prior to the date of initial culture (Q10a)?

Yes No (GO TO Q18) Unknown (GO TO Q18) NA (GO TO Q18)


29a. ENTEROBACTERIACEAE ONLY: WAS THE PATIENT POSITIVE FOR A MuGSI ENTEROBACTERIACEAE IN THE YEAR BEFORE THE DISC?


Yes No Unknown N/A


17d. If yes, specify organism, date of culture and State ID for the first positive

Enterobacteriaceae culture in the year prior to the date of initial culture (Q10a):

Carbapenem-resistant Enterobacteriaceae (CRE):

Escherichia coli

Enterobacter cloacae

Enterobacter aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca


Date of Culture:

□□/□□/□□□□

State ID:________________________



29b. IF YES, SPECIFY ORGANISM, DATE OF CULTURE, AND STATE ID FOR THE FIRST POSITIVE ENTEROBACTERIACEAE CULTURE IN THE YEAR BEFORE THE DISC:

Carbapenem-resistant Enterobacteriaceae (CRE):

Escherichia coli

Enterobacter cloacae

Klebsiella aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca


DATE OF CULTURE: ___ ___ - ___ ___ - ___ ___ ___ ______ __ ___ ___ ___

STATE ID:_____________________


18. Susceptibility Results: (please complete the table below based on the information found in the indicated data source). Shaded antibiotics are required to have the MIC entered into the MuGSI-CM system, if available.

30. SUSCEPTIBILITY RESULTS:

Please complete the table below based on the information found in the indicated data source. Shaded antibiotics are required to have the MIC entered into the MuGSI-CM system, if available.


Add option to collect ten additional drug susceptibilities:

Meropenem-vaborbactam

Minocycline

Doxycycline

Plazomicin

Tetracycline

Rifampin\

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Fosfomycin

Imipenem-relebactam


22. Was case first identified

through audit?

Yes

No

Unknown

31a. WAS CASE FIRST IDENTIFIED THROUGH AUDIT?

Yes

No

23. CRF status:

Complete

Pending

Chart unavailable

31b. CRF STATUS:


Complete

Pending

Chart unavailable after 3 requests

25. SO initials:______________

31c. SO INITIALS: __________


26. Comments:__________________________

_______________________________________


31d. COMMENTS: __________________________________

_________________________________________________



  1. 2019 Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL)


Question on 2018 form

Question on 2019 form

21. Date reported to EIP site:

___ ___ - ___ ___ - ___ ___ ___ ___


DATE REPORTED TO EIP SITE:

___ ___ - ___ ___ - ___ ___ ___ ___


Title: Pilot Assessment: Feasibility of Conducting Surveillance for Extended-Spectrum

Beta-Lactamase-Producing Enterobacteriaceae Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

Title: 2019 Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteriaceae Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

4a. LABORATORY ID WHERE CULTURE IDENTIFIED: ____________________________

4a. LABORATORY ID WHERE INCIDENT SPECIMEN IDENTIFIED: __________________________


6. DATE OF BIRTH:

___ ___ - ___ ___ - ___ ___ ___ ___

5. DATE OF BIRTH:

___ ___ - ___ ___ - ___ ___ ___ ___

7a. AGE:

____ ____ ____


6. AGE

____ ____ ____


Days Mos. Years


7b. Is age in day/mo/yr?

Days Mos. Years


8a. Sex:

Male

Female

Unknown

7. SEX AT BIRTH:

Male Female

Unknown

Check if transgender


8b. ETHNIC ORIGIN:

Hispanic or Latino

Not Hispanic or Latino

Unknown

8a. ETHNIC ORIGIN:

Hispanic or Latino

Not Hispanic or Latino

Unknown

8c. RACE: (Check all that apply)

White

Black or African American

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Unknown

8b. RACE: (Check all that apply)

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Asian

White

Black or African American

Unknown


10a. DATE OF INITIAL CULTURE

___ ___ - ___ ___ - ___ ___ ___ ___

9. DATE OF INCIDENT SPECIMEN COLLECTION (DISC):

___ ___ - ___ ___ - ___ ___ ___ ___


13a. ORGANISM ISOLATED FROM INITIAL NORMALLY STERILE SITE OR URINE:


Extended-Spectrum Cephalosporin-resistant:

Escherichia coli

Klebsiella pneumoniae

Klebsiella oxytoca


10. ORGANISM:


Extended-Spectrum Cephalosporin-resistant:

Escherichia coli

Klebsiella pneumoniae

Klebsiella oxytoca

14. INITIAL CULTURE SITE:

  • Blood

  • Bone

  • Brain

  • CSF

  • Heart

  • Joint/Synovial fluid

  • Kidney

  • Liver

  • Lymph node

  • Ovary

  • Pancreas

  • Pericardial fluid

  • Peritoneal fluid

  • Pleural fluid

  • Spleen

  • Urine

  • Vascular tissue

  • Vitreous

  • Other fluid (sterile)

  • Deep tissue

  • Other normally sterile site ___________


11. Incident specimen collection site (check all that apply)

Blood

Bone

CSF

Internal body site (specify): ________

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Urine

Other normally sterile site (specify): ________


10b. LOCATION OF CULTURE COLLECTION:

  • Hospital Inpatient

  • Emergency Room

  • LTCF Facility ID: ___________

  • LTACH Facility ID: ____________

  • Unknown

  • Other (specify):______________

Outpatient:

  • Clinic/Doctor’s Office

  • Surgery

  • Other Outpatient

  • Dialysis Center

12. LOCATION OF SPECIMEN COLLECTION:

Outpatient

Facility ID:_______

Emergency room

Clinic/Doctor’s office

Dialysis center

Surgery

Observational/clinical decision unit

Other outpatient

Inpatient

Facility ID: ______

ICU

OR

Radiology

Other inpatient

LTCF

Facility ID: ______

LTACH

Facility ID: ______

Autopsy

Other (specify):_______

Unknown

5. Where was the patient located on the 4th calendar day prior to the date of initial culture?

Private residence

LTCF Facility ID:__________

LTACH Facility ID:__________

Homeless

Incarcerated

Hospital inpatient

Was patient transferred from this hospital?

Yes No Unknown

Facility ID: ___________

Other (specify): __________

Unknown


13. WHERE WAS THE PATIENT LOCATED ON THE 3RD CALENDAR DAY BEFORE THE DISC?

Private residence

LTCF

Facility ID: _____

Hospital inpatient

Facility ID: _____

Was patient transferred from this hospital?

Yes No Unknown

LTACH

Facility ID: _____

Homeless

Incarcerated

Other (specify): __________

Unknown




9. WAS PATIENT HOSPITALIZED AT THE TIME OF, OR WITHIN 30 CALENDAR DAYS AFTER, INITIAL CULTURE?

Yes No Unknown


If yes: Date of admission

___ ___ - ___ ___ - ___ ___ ___ ___


Date of discharge

___ ___ - ___ ___ - ___ ___ ___ ___


14. WAS THE PATIENT HOSPITALIZED AT THE TIME OF OR IN THE 29 CALENDAR DAYS AFTER THE DISC?

Yes No Unknown


IF YES, DATE OF ADMISSION:


___ ___ - ___ ___ - ___ ___ ___ ___


11a. Was the patient in the ICU in the 7 days prior to their initial culture?

Yes No Unknown


15a. WAS THE PATIENT IN AN ICU IN THE 7 DAYS BEFORE THE DISC?

Yes No Unknown

IF YES, DATE OF ICU ADMISSION:

___ ___ - ___ ___ - ___ ___ ___ ___ OR □ Date unknown


11b. Was the patient in the ICU on the date of or in the 7 days after the initial culture?

Yes No Unknown


15b. WAS THE PATIENT IN AN ICU ON THE DAY OF INCIDENT SPECIMEN COLLECTION OR IN THE 6 DAYS AFTER THE DISC?

Yes No Unknown

IF YES, DATE OF ICU ADMISSION:

___ ___ - ___ ___ - ___ ___ ___ ___ OR □ Date unknown


12. PATIENT OUTCOME:

Survived

Died

Unknown


If survived, transferred to:

Private residence

LTCF Facility ID:_____

LTACH Facility ID:____

Unknown

Other (specify):_______


If died, date of death:

___ ___ - ___ ___ - ___ ___ ___ ___



16. PATIENT OUTCOME:


Survived

Date of discharge: ___ ___ - ___ ___ - ___ ___ ___ ___ OR

Date unknown

Left against medical advice (AMA)


If survived, discharged to:

Private residence

Other

LTCF Facility ID:_____

(specify):________

LTACH Facility ID:____

Unknown



Died

Date of death: ___ ___ - ___ ___ - ___ ___ ___ ___


ON THE DAY OF OR IN THE 6 CALENDAR DAYS BEFORE DEATH, WAS THE PATHOGEN OF INTEREST ISOLATED FROM A SITE THAT MEETS THE CASE DEFINITION?

Yes No Unknown


16. TYPES OF INFECTION ASSOCIATED WITH CULTURE(S) (check all that apply):

None

Unknown

Abscess, not skin

Appendicitis

AV fistula/graft infection

Bacteremia

Catheter site infection (CVC)

Cholangitis

Chronic ulcer/wound (not decubitus)

Decubitus/pressure ulcer

Diverticulitis

Empyema

Endocarditis

Epididymitis

Epidural Abscess

Meningitis

Osteomyelitis

Peritonitis

Pneumonia

Prostatitis

Pyelonephritis

Septic arthritis

Surgical incision infection

Surgical site infection (internal)

Traumatic wound

Urinary tract infection

Other (specify): ____________


17. TYPES OF INFECTION ASSOCIATED WITH CULTURE(S): (Check all that apply)

None

Unknown

Abscess, not skin

AV fistula/graft infection

Bacteremia

Bursitis

Catheter site infection (CVC)

Cellulitis

Chronic ulcer/wound (not decubitus)

Decubitus/pressure ulcer

Empyema

Endocarditis

Epidural Abscess

Meningitis

Osteomyelitis

Peritonitis

Pneumonia

Pyelonephritis

Septic arthritis

Septic emboli

Septic shock

Skin abscess

Surgical incision infection

Surgical site infection (internal)

Traumatic wound

Urinary tract infection

Other (specify): ____________


Five types of infections were removed from this question.

NEW QUESTION

18. RECURRENT UTI

Yes

No

Unknown

27. UNDERLYING CONDITIONS (check all that apply):

None

Unknown

  • AIDS/CD4 count < 200

  • Alcohol abuse

  • Chronic Liver Disease

  • Chronic Pulmonary Disease

  • Chronic Renal Insufficiency

  • Chronic Skin Breakdown

  • Congestive Heart Failure

  • Connective Tissue Disease

  • Current Smoker

  • CVA/Stroke

  • Cystic Fibrosis

  • Decubitus/Pressure Ulcer

  • Dementia/Chronic Cognitive Deficit

  • Diabetes

  • Hemiplegia/Paraplegia

  • HIV

  • Hematologic Malignancy

  • IVDU

  • Liver failure

  • Metastatic Solid Tumor

  • Myocardial Infarct

  • Neurological Problems

  • Peptic Ulcer Disease

  • Peripheral Vascular Disease (PVD)

  • Premature Birth

  • Solid Tumor (non metastatic)

  • Spina bifida

  • Transplant Recipient

  • Urinary Tract Problems/Abnormalities

19. UNDERLYING CONDITIONS: (Check all that apply)

None

 Unknown

CHRONIC LUNG DISEASE

Cystic fibrosis

Chronic pulmonary disease

CHRONIC METABOLIC DISEASE

Diabetes mellitus

with chronic complications

CARDIOVASCULAR DISEASE

CVA/Stroke/TIA

Congenital heart disease

Congestive heart failure

Myocardial infarction

Peripheral vascular disease (PVD)

GASTROINTESTINAL DISEASE

Diverticular disease

Inflammatory Bowel disease

Peptic ulcer disease

Short gut syndrome

IMMUNOCOMPROMISED CONDITION

HIV infection

AIDS/CD4 count <200

Primary immunodeficiency

Transplant, hematopoietic stem cell

Transplant, solid organ

LIVER DISEASE

Chronic liver disease

Ascites

Chronic hepatitis C

Cirrhosis

Hepatic encephalopathy

Variceal bleeding

Hepatitis C

Treated, in SVR

Current, chronic

MALIGNANCY

Malignancy, hematologic

Malignancy, solid organ (non-metastatic)

Malignancy, solid organ (metastatic)

NEUROLOGIC CONDITION

Cerebral palsy

Chronic cognitive deficit

Dementia

Epilepsy/seizure/ seizure disorder

Multiple sclerosis

Neuropathy

Parkinson’s Disease

Other specify:_____

PLEGIAS/PARALYSIS

Hemiplegia

Paraplegia

Quadriplegia

RENAL DISEASE

Chronic kidney disease

Lowest serum creatinine:____mg/Dl

SKIN CONDITION

Burn

Decubitus/pressure ulcer

Surgical wound

Other chronic ulcer or chronic wound

OTHER

Connective tissue disease

Obesity or morbid obesity

Pregnant

MuGSI CONDITIONS

Urinary tract problems/abnormalities

Premature birth

Spina bifida



27. UNDERLYING CONDITIONS (check all that apply):

None

Unknown

  • AIDS/CD4 count < 200

  • Alcohol abuse

  • Chronic Liver Disease

  • Chronic Pulmonary Disease

  • Chronic Renal Insufficiency

  • Chronic Skin Breakdown

  • Congestive Heart Failure

  • Connective Tissue Disease

  • Current Smoker

  • CVA/Stroke

  • Cystic Fibrosis

  • Decubitus/Pressure Ulcer

  • Dementia/Chronic Cognitive Deficit

  • Diabetes

  • Hemiplegia/Paraplegia

  • HIV

  • Hematologic Malignancy

  • IVDU

  • Liver failure

  • Metastatic Solid Tumor

  • Myocardial Infarct

  • Neurological Problems

  • Peptic Ulcer Disease

  • Peripheral Vascular Disease (PVD)

  • Premature Birth

  • Solid Tumor (non metastatic)

  • Spina bifida

  • Transplant Recipient

Urinary Tract Problems/Abnormalities

20. SUBSTANCE USE, CURRENT


SMOKING (Check all that apply):

None

Unknown

Tobacco

E-nicotine delivery system

Marijuana


ALCOHOL ABUSE:

Yes

No

Unknown


OTHER SUBSTANCES: (Check all that apply)


None


Unknown

DOCUMENTED USE

DISORDER (DUD)/ABUSE: MODE OF DELIVERY: (Check all that apply)


Marijuana/cannabinoid (other than smoking) □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Opioid, DEA schedule I (e.g., heroin) □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Opioid, DEA schedule II-IV (e.g., methadone, oxycodone) □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Cocaine or methamphetamine □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Other (specify): ___________ □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Unknown substance □ DUD or abuse □ IDU □ Skin popping □ Non-IDU □ Unknown


Some of the data in this section was formerly collected in the underlying conditions section (IVDU [changed to injection drug user], Current smoker [changed to smoking], Alcohol Abuse (see highlighted conditions in the prior column). The collection of more information for other drug use is new.

There are six new check boxes that allow other drug use to be captured in more detail. These questions focus on type of drug and mode of delivery.


21. RISK FACTORS OF INTEREST (check all that apply):


None

Unknown


Hospitalized within year before date of initial culture:

If yes, enter mo/yr □□/□□□□

OR Unknown

If known, prior hospital ID:_________________


Surgery within year before date of initial culture


Current chronic dialysis:

Hemodialysis □ Peritoneal □ Unknown

Hemodialysis Access:

AV fistula/graft □ CVC □ Unknown


Residence in LTCF within year before date of initial culture If known,

facility ID: ______________________


Admitted to a LTACH within year before initial culture date

If known, facility ID: ______________________


Central venous catheter in place on the day of culture (up to time of culture) or at

any time in the 2 calendar days prior to the date of culture


Urinary catheter in place on the day of culture (up to time of culture) or at any

time in the 2 calendar days prior to the date of culture

If checked, indicate all that apply:

Indwelling Urethral Catheter

Suprapubic Catheter

Condom Catheter

Other: _____________


Any OTHER indwelling device in place on the day of culture (up to time of culture)

or at any time in the 2 calendar days prior to the date of culture

If checked, indicate all that apply:

ET/NT Tube

Gastrostomy Tube

NG Tube

Tracheostomy

Nephrostomy Tube

Other: _____________


Patient traveled internationally in the two months prior to the date of initial culture.


Country:__________________, ___________________, __________________


Patient was hospitalized while visiting country(ies) listed above


21. RISK FACTORS: (Check all that apply)


None

Unknown


WAS INCIDENT SPECIMEN COLLECTED 3 OR MORE CALENDAR DAYS AFTER HOSPITAL ADMISSION?

Yes No (please note, this field is auto calculated in the data management system (DMS), therefore, the user does not ever complete this filed and there is not burden associated with its collection. It is on the paper form because our users want to continue to view this in the DMS)


Previous hospitalization in the year before DISC

Yes No Unknown

If yes, date of discharge closed to DISC:

___ ___ - ___ ___ - ___ ___ ___ ___

Facility ID: ___________

OR, Date Unknown


Overnight stay in LTCF in the year before DISC

Yes No Unknown

Facility ID: ___________


Overnight stay in LTACH in the year before DISC

Yes No Unknown

Facility ID: ___________


Surgery in the year before DISC

Yes No Unknown


CURRENT CHRONIC DIALYSIS:

IF YES, TYPE:

Hemodialysis □ Peritoneal □ Unknown

IF HEMODIALYSIS, TYPE OF VASCULAR ACCESS:

AV fistula/graft □ Hemodialysis central line □ Unknown


CENTRAL LINE IN PLACE ON THE DISC (UP TO THE TIME OF COLLECTION), OR AT ANY TIME IN THE 2 CALENDAR DAYS BEFORE DISC:

Yes No Unknown

Check here if central line in place for > 2 calendar days: □


URINARY CATHETER IN PLACE ON THE DISC (UP TO THE TIME OF COLLECTION), OR AT ANY TIME IN THE 2 CALENDAR DAYS BEFORE DISC:

Yes No Unknown

IF YES, CHECK ALL THAT APPLY:

Indwelling Urethral Catheter

Suprapubic Catheter

Condom Catheter

Other (specify):__________


ANY OTHER INDWELLING DEVICE IN PLACE ON THE DISC (UP TO THE TIME OF COLLECTION), OR AT ANY TIME IN THE 2 CALENDAR DAYS BEFORE DISC:

Yes No Unknown

IF YES, CHECK ALL THAT APPLY:

ET/NT Tube □ Gastrostomy Tube □ NG Tube

Tracheostomy □ Nephrostomy Tube □ Other (specify):_____


PATIENT TRAVELED INTERNATIONALLY IN THE YEAR BEFORE DISC:

Yes No Unknown

COUNTRY: ______, ______, ______


PATIENT HOSPITALIZED WHILE VISITING COUNTRY(IES) ABOVE:

Yes No Unknown


NEW QUESTION

22a. WEIGHT:

_________lbs. ______ oz. OR _____kg □ Unknown

NEW QUESTION

22b. HEIGHT:

_________ft. _______ in. OR _____cm □ Unknown

NEW QUESTION

23c. BMI:

_________ □ Unknown

NEW QUESTION

URINE CULTURES ONLY:

23a. RECORD THE COLONY COUNT: ________________


URINE Cultures ONLY:

14b. Signs and Symptoms associated with urine culture.

Please indicate if any of the following symptoms where reported during the 5 day time period

including the 2 calendar days before through the 2 calendar days after the date of initial culture.

Then go to question 14d.

None

Costovertebral angle pain or tenderness

Dysuria

Fever [temperature ≥ 100.4 °F (38 °C)]

Unknown

Frequency

Suprapubic tenderness

Urgency


URINE CULTURES ONLY:

23b. SIGNS AND SYMPTOMS ASSOCIATED WITH URINE CULTURE

Please indicate if any of the following symptoms where reported during the 5 day time period including the 2 calendar days before through the 2 calendar days after the DISC.

None

Costovertebral angle pain or tenderness

Dysuria

Fever [temperature ≥ 100.4 °F (38 °C)]

Unknown

Frequency

Suprapubic tenderness

Urgency

Symptoms for patients 1 year of age only:

Apnea

Bradycardia

Lethargy

Vomiting

15b. Did clinical laboratory identify isolate as ESBL producer?

Yes No Unknown


This question was removed.

NEW QUESTION

24a. WAS THE INCIDENT SPECIMEN POLYMICROBIAL?

Yes

No

Unknown


15c. What confirmatory testing method(s) was used? (Check all that apply):

Broth Microdilution (ATI)

Disk Diffusion

Other (Specify):____________

None

Unknown



24b. WHAT SCREENING/ CONFIRMATORY METHOD WAS USED FOR ESBL DETECTION? (Check all that apply):

Broth Microdilution (ATI detection)

ESBL well

Expert rule (ATI flag)

Broth Microdilution (Manual)

Disk Diffusion

E-test

Molecular test (specify):____________

Other non-molecular test (specify):________

None

Unknown


15d. IF TESTED, what was the test result?


Positive

Negative

Indeterminate

Unknown


24c. IF SCREENING/ CONFIRMATORY METHOD WAS USED, WHAT WAS THE RESULT?


Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown

Positive

Negative

Indeterminate

Unknown



19a. Is antimicrobial use (IV or oral) in the 30 days before the date of initial culture collection documented in the H&P or medical administration record?


Yes (complete 19b)

No

Unknown


25a. IS ANTIMICROBIAL USE (IV OR ORAL) IN THE 30 DAYS BEFORE THE DISC DOCUMENTED?


Yes

No

Unknown

19b . If yes, indicate all antibiotics given in the 30 days before the date of initial culture collection:


  • Amikacin

  • Amoxicillin

  • Amoxicillin/Clavulanic Acid

  • Ampicillin/Sulbactam

  • Azithromycin

  • Aztreonam

  • Cefaclor

  • Cefazolin

  • Cefdinir

  • Cefepime

  • Cefotaxime

  • Cefpodoxime

  • Cefprozil

  • Ceftazidime

  • Ceftazidime/Avibactam

  • Ceftizoxime

  • Ceftolozane/Tazobactam

  • Ceftriaxone

  • Cefuroxime

  • Cephalexin

  • Ciprofloxacin

  • Clarithromycin

  • Clindamycin

  • Colistin

  • Daptomycin

  • Doripenem

  • Doxycycline

  • Ertapenem

  • Fosfomycin

  • Gentamicin

  • Imipenem

  • Levofloxacin

  • Linezolid

  • Meropenem

  • Metronidazole

  • Moxifloxacin

  • Nitrofurantoin

  • Ofloxacin

  • Penicillin

  • Piperacillin-Tazobactam

  • Polymyxin B

  • Rifampin

  • Tetracycline

  • Ticarcillin/Clavulanic Acid

  • Tigecycline

  • Tobramycin

  • Trimethoprim-Sulfamethoxazole

  • Vancomycin, IV

  • Vancomycin, oral

  • Unknown

  • Other (specify):___________________

  • Other (specify):___________________

25b. IF YES, CHECK ALL ANTIMICROBIALS USED IN THE 30 DAYS BEFORE THE DISC: (Check all that apply)


Unknown

Amikacin

Amoxicillin

Amoxicillin/clavulanic acid

Ampicillin

Ampicillin/sulbactam

Azithromycin

Aztreonam

Cefazolin

Cefdinir

Cefepime

Cefixime

Cefotaxime

Cefoxitin

Cefpodoxime

Ceftaroline

Ceftazidime

Ceftazidime/avibactam

Ceftizoxime

Ceftolozane/tazobactam

Ceftriaxone

Cefuroxime

Cephalexin

Ciprofloxacin

Clarithromycin

Clindamycin

Dalbavancin

Daptomycin

Delafloxacin

Doripenem

Doxycycline

Ertapenem

Fidaxomicin

Fosfomycin

Gentamicin

Imipenem/cilastatin

Levofloxacin

Linezolid

Meropenem

Meropenem/vaborbactam

Metronidazole

Moxifloxacin

Nitrofurantoin

Oritavancin

Penicillin

Piperacillin/tazobactam

Polymyxin B

Polymyxin E (colistin)

Rifaximin

Tedizolid

Telavancin

Tigecycline

Tobramycin

Trimethoprim

Trimethoprim/sulfamethoxazole

Vancomycin

IV

PO

Other (specify): _____________________

Other (specify): _____________________

Other (specify): _____________________



15a. Susceptibility Results: Please complete the table below based on the primary antibiotic testing report. Shaded antibiotics are required to have the MIC

entered into the ESBL Case Management system, if available.

26. SUSCEPTIBILITY RESULTS:

Please complete the table below based on the information found in the indicated data source. Shaded antibiotics are required to have the MIC entered into the MuGSI-CM system, if available.


Remove:

Other (Specify):_________________


Add:

Medical record column

Meropenem-vaborbactam

Minocycline

Doxycycline

Plazomicin

Tetracycline

Rifampin

Imipenem-relebactam


7 new antibiotic were added to this form for consistency with the CRE/CRAB CRF.


27a. WAS CASE FIRST IDENTIFIED THROUGH AUDIT?

Yes

No

20. CRF status:

Complete

Pending

Chart unavailable

27b. CRF STATUS:


Complete

Pending

Chart unavailable after 3 requests

22. SO initials:______________

27c. SO INITIALS: __________


23. Comments:__________________________

_______________________________________


27d. COMMENTS: __________________________________

_________________________________________________



  1. Multi-site Gram-Negative Surveillance Initiative (MuGSI)- Carbapenem-resistant Pseudomonas aeruginosa (CR-PA) - Form Discontinued

  2. 2019 Invasive MRSA Infection Case Report Form

2018 Paper CRF Question

Changes to the 2019 Paper CRF Question

1. State (Residence of patient)

___ ___

1. State

___ ___

(Updated question wording)

2. County (Residence of patient)

__________

2. County

__________

(Updated question wording)

3. State I.D.: __________

3. State I.D.: __________

(No change)

Patient ID: ______________

4. Patient ID: _____________

(Updated question number; this was previously at the top of the CRF and not numbered).

4a. Hospital/Lab I.D. where culture identified

__________

5. Laboratory ID where incident specimen identified

__________

(Updated question number and wording)

4b. Hospital I.D. where patient treated

_________

6. Facility ID where patient treated

__________

(Updated question number and wording)

5. Sex:

Male

Female

7. Sex at birth:

Male Female

Unknown

Check if transgender

(Updated question number and wording, added two new options—one for unknown sex at birth and a checkbox if the patient is transgender)

6. Date of Birth

__/__/______

8. Date of birth

__/__/______

(Updated question number)

7. Age

____ ____ ____

9. Age

____ ____ ____

Days Mos. Years

(Updated question number and combined with question below [7b on old form])

7b. Is age in day/mo/yr

Days Mos. Years


This text (Is age in day/mo/yr) has been removed and the option day/mo/year is now included as a part of question 9

12b. Race

White

Black or African American

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Unknown

10. Race (Check all that apply)

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Asian

White

Black or African American

Unknown

(Updated question number and order of responses; all response options remain the same)

12a. Ethnic Origin

Hispanic or Latino

Not Hispanic or Latino

Unknown

11. Ethnic origin

Hispanic or Latino

Not Hispanic or Latino

Unknown

(Updated question number)

12c. Weight

Unknown

_____ lbs _____oz OR _____kg


12. Weight

_____ lbs _____oz OR

_____kg Unknown

(Updated question number and order of responses; all response options remain the same)

12d. Height

Unknown

_____ft. ­­­_____ in. OR _____cm


13. Height

_____ft. ­­­_____ in. OR

_____cm Unknown

(Updated question number and order of responses; all response options remain the same)

12e. BMI (do not calculate, only if available in the MR)

Unknown

_____

14. BMI (record only if ht. and/or wt. is not available)

_____ Unknown

(Updated question number, wording, and order of responses; all response options remain the same)

9. Date of Initial Culture

___/___/______

15. Date of Incident Specimen Collection (DISC)

___/___/______

(Updated question number and wording)

10a. Was the patient hospitalized at the time of, or within 30 calendar days after, initial culture?

Yes No Unknown

If yes, date of admission ___/___/______

16. Was the patient hospitalized at the time of, or in the 29 calendar days after, the DISC?

Yes No Unknown

If yes, date of admission ___/___/______

(Updated question number and wording)

11. Was culture collected >3 calendar days after hospital admission?

Yes (HO-MRSA case) No (Complete CRF, CA-MRSA or HACO-MRSA case)


If yes, was case selected for full CRF based on sampling frame 1:10?

Yes (Complete CRF) No (STOP data abstraction)

17. Was incident specimen collected 3 or more calendar days after hospital admission?

Yes (HO-MRSA case) No (CA-MRSA or HACO-MRSA case)


(Updated question number and wording, dropped second part of question, “If yes, was case selected for full CRF based on sampling frame 1:10?”)

8. Sterile site(s) from which MRSA was initially isolated (check all that apply)

Blood

CSF

Pleural fluid

Peritoneal fluid

Pericardial fluid

Joint/Synovial fluid

Bone

Muscle

Internal body site (specify________)

Other sterile site (specify________)

18. Incident specimen collection site (check all that apply)

Blood

Bone

CSF

Internal body site (specify________)

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Other normally sterile site (specify________)

(Updated question number, wording, order of responses, and wording of one response options [other sterile site is now other normally sterile site], though all response options remain the same)

16. Location of culture collection (check one)

Hospital inpatient

ICU

Surgery/OR

Radiology

Other unit

Outpatient

Clinic/Doctor’s office

Surgery

Dialysis/Renal Clinic

Other outpatient


Emergency Room

Observational Unit/clinical decision unit

LTCF

Facility ID:_______

LTACH

Facility ID: ­­­­_______

Autopsy

Unknown

Other

19. Location of specimen collection

Outpatient

Facility ID:_______

Emergency room

Clinic/Doctor’s office

Dialysis center

Surgery

Observational/clinical decision unit

Other outpatient

Inpatient

Facility ID: ______

ICU

OR

Radiology

Other inpatient

LTCF

Facility ID: ______

LTACH

Facility ID: ______

Autopsy

Other (specify):_______

Unknown


(Updated question number. Added checkboxes for headings “Outpatient” and “Inpatient”. Added a facility ID for “Outpatient” and “Inpatient”. Updated the order of responses. Changed the wording of the response “Dialysis/Renal clinic to “Dialysis” and “Other unit” to “Other inpatient”)

17. Were cultures of the SAME or OTHER sterile sites positive within 30 days after initial culture date?

Yes No Unknown

If yes, indicate site and date of last positive culture.

Blood, Date:_______

CSF, Date: _______

Pleural fluid, Date:_______

Peritoneal fluid, Date: _______

Pericardial fluid, Date: _______

Joint/Synovial fluid, Date: _______

Bone, Date: _______

Muscle, Date: _______

Internal body site (specify________) Date: _______

Other sterile site (specify________) Date: _______

20. Were cultures of the SAME or OTHER sterile site(s) positive within 29 days after DISC?

Yes No Unknown

If yes, indicate site and date of last positive culture.

Blood, Date:______

Bone, Date:______

CSF, Date:______

Internal body site (specify________), Date:______

Joint/Synovial fluid, Date:______

Muscle, Date:______

Pericardial fluid, Date:______

Peritoneal fluid, Date:______

Pleural fluid, Date:______

Other normally sterile site (specify____) Date:______

(Updated question number and wording, order of responses, and wording of one of the response options [other sterile site is now other normally sterile site])

17b. Date of first SA blood culture after which SA not isolated for 14 days

___/___/______

21. Date of first SA blood culture after which SA not isolated for 14 days

___/___/______

(Updated question number)

22. Susceptibility Results

Cefoxitin S R U

Oxacillin S R U

Vancomycin S I R U

Clindamycin S I R U

Trimethoprim-sulfamethoxazole S I R U

22. Susceptibility Results

Cefazolin S I R U

Nafcillin S I R U

Cefoxitin S R U

Oxacillin S R U

Vancomycin S I R U

Clindamycin S I R U

Trimethoprim-sulfamethoxazole S I R U

(Added two antimicrobial agents-Cefazolin and Nafcillin)

15. Where was the patient located on the 4th calendar day prior to the date of initial culture?

Private residence

Long term care facility

Facility ID:

Long term acute care hospital

Facility ID:

Homeless

Incarcerated

Hospital inpatient

Facility ID:

Other____________

Unknown

23. Where was the patient located on the 3rd calendar day before the DISC?

Private residence

LTCF

Facility ID:

Hospital inpatient

Facility ID:

Was patient transferred from this hospital?

Yes No Unknown

LTACH

Facility ID:

Homeless

Incarcerated

Other:­­­__________

Unknown


(Updated question number and wording, Updated order of the responses, added the response: Was patient transferred from this hospital? Yes No Unknown for patients that were indicated to be a hospital inpatient.)


14. If case is 12 months of age, type of birth hospitalization

NICU/SCN

Well baby nursery

Unknown

24. If case is 12 months of age, type of birth hospitalization

NICU/SCN

Well baby nursery

Unknown

(Updated question number)

20. Underlying conditions:

Premature birth

Birth weight _____ lb _____oz OR ______ g

Estimated gestational age ______ weeks

25. If patient <2 years of age were they born premature (<37 weeks gestation)?

Yes No Unknown

---If YES, birth weight: _____ lb _____oz OR ______ g

OR Unknown birth weight

---If YES, estimated gestational age: ______ weeks

OR Unknown gestational age


(Updated question number and wording. Added “Unknown” checkboxes for birth weight and gestational age)

10b. If patient was hospitalized, was this patient admitted to the ICU during hospitalization?

Yes No Unknown

26. Was the patient in an ICU in the 2 days before the DISC?

Yes No Unknown

---if YES, date of ICU admission: _ _-_ _-_ _ _ _

OR Date Unknown

(Updated question number and wording, broke into two questions, added date of admission)

10b. If patient was hospitalized, was this patient admitted to the ICU during hospitalization?

Yes No Unknown

27. Was the patient in an ICU on the DISC or in the 2 days after the DISC?

Yes No Unknown

---if YES, date of ICU admission: _ _-_ _-_ _ _ _

OR Date Unknown

(Updated question number and wording, broke into two questions, added date of admission)

19. Types of MRSA infection associated with culture(s)


Abscess (not skin)

Peritonitis

AV Fistula/Graft infection

Pneumonia

Bacteremia

Osteomyelitis

Bursitis

Septic Arthritis

Catheter Site Infection

Septic Emboli

Cellulitis

Septic Shock

Chronic Ulcer/Wound

Skin Abscess

Decubitus/Pressure

Ulcer

Surgical Incision

Empyema

Surgical Site (internal)

Endocarditis

Urinary Tract

Epidural abscess

Other (Specify):____

Meningitis



28. Types of MRSA infection associated with culture(s)


Abscess (not skin)

Peritonitis

AV Fistula/Graft infection

Pneumonia

Bacteremia

Osteomyelitis

Bursitis

Septic Arthritis

Catheter Site Infection

Septic Emboli

Cellulitis

Septic Shock

Chronic Ulcer/Wound

Skin Abscess

Decubitus/Pressure Ulcer

Surgical Incision

Empyema

Surgical Site (internal)

Endocarditis

Urinary Tract

Epidural abscess

Other (Specify):____

Meningitis



(Updated question number, no change to the responses)

20. Underlying Conditions

Abscess/Boil (Recurrent)

AIDS

Chronic Cognitive Deficit

Chronic Liver Disease

Chronic Pulmonary Disease

Chronic Kidney Disease

Chronic Skin Breakdown

Congestive Heart Failure

Connective Tissue Disease

Current Smoker

CVA/Stroke

Cystic fibrosis

Decubitus/Pressure Ulcer

Dementia

Diabetes

Hematologic Malignancy

Hemiplegia/Paraplegia

HIV

Influenza (within 10 days of initial culture)


IVDU

Metastatic solid tumor

Myocardial Infarct

Obesity

Other drug use

Peptic ulcer disease

Peripheral vascular disease

Premature birth

Birth weight _____ lb _____oz OR ______ g

Estimated gestational age ______ weeks

Solid tumor (non metastatic)

Other (Specify for cases 12 months of age):


29. Underlying Conditions

CHRONIC LUNG DISEASE

Cystic fibrosis

Chronic pulmonary disease

CHRONIC METABOLIC DISEASE

Diabetes mellitus

with chronic complications

CARDIOVASCULAR DISEASE

CVA/Stroke/TIA

Congenital heart disease

Congestive heart failure

Myocardial infarction

Peripheral vascular disease (PVD)

GASTROINTESTINAL DISEASE

Diverticular disease

Inflammatory Bowel disease

Peptic ulcer disease

Short gut syndrome

IMMUNOCOMPROMISED CONDITION

HIV infection

AIDS/CD4 count <200

Primary immunodeficiency

Transplant, hematopoietic stem cell

Transplant, solid organ

LIVER DISEASE

Chronic liver disease

Ascites

Cirrhosis

Hepatic encephalopathy

Variceal bleeding

Hepatitis C

Treated, in SVC

Current, chronic

MALIGNANCY

Malignancy, hematologic

Malignancy, solid organ (non-metastatic)

Malignancy, solid organ (metastatic)

NEUROLOGIC CONDITION

Cerebral palsy

Chronic cognitive deficit

Dementia

Epilepsy/seizure/ seizure disorder

Multiple sclerosis

Neuropathy

Parkinson’s Disease

Other specify:_____

PLEGIAS/PARALYSIS

Hemiplegia

Paraplegia

Quadriplegia

RENAL DISEASE

Chronic kidney disease

Lowest serum creatinine:____mg/Dl

SKIN CONDITION

Burn

Decubitus/pressure ulcer

Surgical wound

Other chronic ulcer or chronic wound


OTHER

Connective tissue disease

Obesity or morbid obesity

Pregnant

Other (specify only for cases 12 months of age):___________


(Updated question number, re-ordered options based on system and alphabet, moved 6 conditions to another location on the CRF [IVDU, Other drug use, Current smoker, Premature birth, birth weight, estimated gestational age], removed 2 conditions [abscess/boil (recurrent), influenza (within 10 days of initial culture)], and added 22 conditions [an option under diabetes for “with chronic complications”; congenital heart disease; diverticular disease; inflammatory bowel disease; cerebral palsy; epilepsy/seizure/seizure disorder; multiple sclerosis; neuropathy; Parkinson’s disease; other neurologic condition; quadriplegia; lowest serum creatinine for those with chronic kidney disease; surgical wound; other chronic ulcer or wound; primary immunodeficiency; transplant, hematopoietic stem cell; transplant, solid organ; ascites; hepatitis C; 2 options under hepatitis C: treated, in SVR and current, chronic, cirrhosis; hepatic encephalopathy; variceal bleeding]. There were minor wording changes for eight conditions [CVA/stroke to CVA/Stroke/TIA; Diabetes to Diabetes mellitus; Hematologic malignancy to Malignancy, hematologic; metastatic solid tumor to Malignancy, solid organ (metastatic); myocardial infarct to myocardial infarction; obesity to obesity or morbid obesity; peripheral vascular disease to peripheral vascular disease (PVD); solid tumor (non metastatic) to Malignancy, solid organ (non-metastatic)], one question was broken into two [Hemiplegia and paraplegia are now their own checkboxes rather than hemiplegia/paraplegia). One condition (pregnancy) was added to this question, but had previously stood as a stand-alone question (Q13).

20. Underlying Conditions

Abscess/Boil (Recurrent)

AIDS

Chronic Cognitive Deficit

Chronic Liver Disease

Chronic Pulmonary Disease

Chronic Kidney Disease

Chronic Skin Breakdown

Congestive Heart Failure

Connective Tissue Disease

Current Smoker

CVA/Stroke

Cystic fibrosis

Decubitus/Pressure Ulcer

Dementia

Diabetes

Hematologic Malignancy

Hemiplegia/Paraplegia

HIV

Influenza (within 10 days of initial culture)


IVDU

Metastatic solid tumor

Myocardial Infarct

Obesity

Other drug use

Peptic ulcer disease

Peripheral vascular disease

Premature birth

Birth weight _____ lb _____oz OR ______ g

Estimated gestational age ______ weeks

Solid tumor (non metastatic)

Other (Specify for cases 12 months of age):______


30. Substance Use, current

Smoking: (Check all that apply)

None

Unknown

Tobacco

Marijuana

E-nicotine delivery system



Alcohol Abuse:

Yes

Unknown

No



Other Substances (Check all that apply):

None

Unknown


Documented use disorder (DUD)/abuse:

Mode of delivery (Check all that apply):


Marijuana/cannabinoid (other than smoking)

DUD or abuse

IDU Skin popping Non-IDU Unknown

Opioid, DEA schedule I (e.g., heroin)

DUD or abuse

IDU Skin popping Non-IDU Unknown

Opioid, DEA schedule II-IV (e.g., methadone, oxycodone)

DUD or abuse

IDU Skin popping Non-IDU Unknown

Cocaine or methamphetamine

DUD or abuse

IDU Skin popping Non-IDU Unknown

Other (Specify):

DUD or abuse

IDU Skin popping Non-IDU Unknown

Unknown substance

DUD or abuse

IDU Skin popping Non-IDU Unknown


The data in this section was formerly collected in the underlying conditions section (IVDU [changed to injection drug user], Current smoker [changed to smoking], and other drug use). See the highlighted conditions in the prior column.


There are six new check boxes that allow “other drug” use to be captured in more detail. These questions focus on type of drug and mode of delivery.

13.At the time of first positive culture, patient was:

Pregnant

Post-partum

Neither

Unknown

This question has been deleted. A pregnancy checkbox is now included in Q20, underlying conditions

21. Prior healthcare exposure

None Unknown

Previous document MRSA infection or colonization

If yes, Month____ Year ______

or previous state id: _________



Hospitalized within year before initial culture date

If yes, Month ____ Day ____ Year ________ Unknown

If known, Facility ID: ___________



Admitted to a LTACH within year before initial culture date

If known, Facility ID: _____________


Residence in a long-term care facility within year before initial culture date

If known, Facility ID: _____________


Surgery within year before initial culture date



If yes, list the surgeries and dates of surgery that occurred within 90 days prior to the initial culture:

Surgery

Date

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____


Central vascular catheter in place at or any time in the 2 calendar days prior to initial culture



Dialysis within year before initial culture date (hemodialysis or peritoneal dialysis)



Current chronic dialysis

Type Peritoneal Unknown

Hemodialysis

Type of vascular access

AV fistula/graft

Hemodialysis CVC

Unknown

31. Prior healthcare exposure(s)


Previous documented MRSA infection or colonization

Yes No Unknown

If yes, Month____ Year ______

or previous state id: _________


Previous hospitalization in the year before DISC

Yes No Unknown

If yes, date of discharge closed to DISC: ___/___/___

Facility ID: ___________


Overnight stay in LTACH in the year before DISC

Yes No Unknown

Facility ID: ___________


Overnight stay in LTCF in the year before DISC

Yes No Unknown

Facility ID: ___________


Surgery in the year before DISC

Yes No Unknown

If yes, list the surgeries and dates of surgery that occurred within 90 days prior to the DISC:

Surgery

Date

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____


Central line in place on the DISC (up to the time of collection), or at any time in the 2 calendar days before DISC Yes No Unknown


Dialysis in the year before DISC (hemodialysis or peritoneal dialysis)

Yes No Unknown


Current chronic dialysis Yes No Unknown

Type: Hemodialysis Peritoneal Unknown

If hemodialysis, type of vascular access:

AV fistula/graft Hemodialysis central line

Unknown



(Updated question number and wording. Checkboxes were updated to yes/no/unknown responses, removing the need for None/Unknown checkboxes on prior CRF. Order of sub-questions has changed [not shown].)


18. Patient outcome

Survived

Date of discharge: __/__/____

If survived, was the patient transferred to a LTCF?

Yes No Unknown

If yes, facility ID: _________________

If survived, was the patient transferred to a LTACH?

Yes No Unknown

If yes, facility ID: _________________


Died

Date of death: __/__/____

Was MRSA cultured from a normally sterile site < calendar day 7 before death? Yes No Unknown



Unknown

32. Patient outcome

Survived

Date of discharge: __/__/____

Left against medical advice (AMA)

If survived, discharged to:

Private residence

Other

LTCF Facility ID:_____

Specify:________

LTACH Facility ID:____

Unknown



Died

Date of death: __/__/____

On the day of or in the 6 calendar days before death, was the pathogen of interest isolate from a site that meets the case definition? Yes No Unknown


Unknown


(Updated question number and wording. Collapsed two questions (If patient survived, was the patient transferred to a LTCF and If patient survived was the patient transferred to a LTACH) into a single question (If survived, discharged to) and added a checkbox for “left against medical advice” and for “date unknown” (for both date of discharge [if survived] and date of death [if died])

23. Was case first identified through audit?

Yes No Unknown

33. Was case first identified through audit?

Yes No Unknown

(Updated question number)

24. CRF status

Complete

Incomplete

Edited & Correct

Chart unavailable after 3 requests

34. CRF Status

Complete

Incomplete

Edited & Correct

Chart unavailable after 3 requests

(Updated question number)

25. Does this case have recurrent MRSA disease?

Yes No Unknown

If yes, previous (1st) state ID _______________

35. Does this case have recurrent MRSA disease?

Yes No Unknown

If yes, previous (1st) state ID ___________________

(Updated question number)

26. Date reported to EIP site

___/___/______

36. Date reported to EIP site

___/___/______

(Updated question number)

27. Initials of S.O.

__________

37. S.O. Initials

____________

(Updated question number and wording)

  1. 2019 Invasive MSSA Infections Case Report Form

2018 Paper CRF Question

Changes to the 2019 Paper CRF Question

1. State (Residence of patient)

___ ___

1. State

___ ___

(Updated question wording)

2. County (Residence of patient)

__________

2. County

__________

(Updated question wording)

3. State I.D.: __________

3. State I.D.: __________

(No change)

Patient ID: ______________

4. Patient ID: _____________

(Updated question number; this was previously at the top of the CRF and not numbered).

4a. Hospital/Lab I.D. where culture identified

__________

5. Laboratory ID where incident specimen identified

__________

(Updated question number and wording)

4b. Hospital I.D. where patient treated

_________

6. Facility ID where patient treated

__________

(Updated question number and wording)

5. Sex:

Male

Female

7. Sex at birth:

Male Female

Unknown

Check if transgender

(Updated question number and wording, added two new options—one for unknown sex at birth and a checkbox if the patient is transgender)

6. Date of Birth

__/__/______

8. Date of birth

__/__/______

(Updated question number)

7. Age

____ ____ ____

9. Age

____ ____ ____

Days Mos. Years

(Updated question number and combined with question below [7b on old form])

7b. Is age in day/mo/yr

Days Mos. Years


This text (Is age in day/mo/yr) has been removed and the option day/mo/year is now included as a part of question 9

12b. Race

White

Black or African American

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Unknown

10. Race (Check all that apply)

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Asian

White

Black or African American

Unknown

(Updated question number and order of responses; all response options remain the same)

12a. Ethnic Origin

Hispanic or Latino

Not Hispanic or Latino

Unknown

11. Ethnic origin

Hispanic or Latino

Not Hispanic or Latino

Unknown

(Updated question number)

12c. Weight

Unknown

_____ lbs _____oz OR _____kg


12. Weight

_____ lbs _____oz OR

_____kg Unknown

(Updated question number and order of responses; all response options remain the same)

12d. Height

Unknown

_____ft. ­­­_____ in. OR _____cm


13. Height

_____ft. ­­­_____ in. OR

_____cm Unknown

(Updated question number and order of responses; all response options remain the same)

12e. BMI (do not calculate, only if available in the MR)

Unknown

_____

14. BMI (record only if ht. and/or wt. is not available)

_____ Unknown

(Updated question number, wording, and order of responses; all response options remain the same)

9. Date of Initial Culture

___/___/______

15. Date of Incident Specimen Collection (DISC)

___/___/______

(Updated question number and wording)

10a. Was the patient hospitalized at the time of, or within 30 calendar days after, initial culture?

Yes No Unknown

If yes, date of admission ___/___/______

16. Was the patient hospitalized at the time of, or in the 29 calendar days after, the DISC?

Yes No Unknown

If yes, date of admission ___/___/______

(Updated question number and wording)

11. Was culture collected >3 calendar days after hospital admission?

Yes (HO case) No

17. Was incident specimen collected 3 or more calendar days after hospital admission?

Yes (HO-MSSA case) No (CA-MSSA or HACO-MSSA case)

8. Sterile site(s) from which MSSA was initially isolated (check all that apply)

Blood

CSF

Pleural fluid

Peritoneal fluid

Pericardial fluid

Joint/Synovial fluid

Bone

Muscle

Internal body site (specify________)

Other sterile site (specify________)

18. Incident specimen collection site (check all that apply)

Blood

Bone

CSF

Internal body site (specify________)

Joint/Synovial fluid

Muscle

Pericardial fluid

Peritoneal fluid

Pleural fluid

Other normally sterile site (specify________)

(Updated question number, wording, order of responses, and wording of one response options [other sterile site is now other normally sterile site], though all response options remain the same)

16. Location of culture collection (check one)

Hospital inpatient

ICU

Surgery/OR

Radiology

Other unit

Outpatient

Clinic/Doctor’s office

Surgery

Dialysis/Renal Clinic

Other outpatient


Emergency Room

Observational Unit/clinical decision unit

LTCF

Facility ID:_______

LTACH

Facility ID: ­­­­_______

Autopsy

Unknown

Other

19. Location of specimen collection

Outpatient

Facility ID:_______

Emergency room

Clinic/Doctor’s office

Dialysis center

Surgery

Observational/clinical decision unit

Other outpatient

Inpatient

Facility ID: ______

ICU

OR

Radiology

Other inpatient

LTCF

Facility ID: ______

LTACH

Facility ID: ______

Autopsy

Other (specify):_______

Unknown


(Updated question number. Added checkboxes for headings “Outpatient” and “Inpatient”. Added a facility ID for “Outpatient” and “Inpatient”. Updated the order of responses. Changed the wording of the response “Dialysis/Renal clinic to “Dialysis” and “Other unit” to “Other inpatient”)

17. Were cultures of the SAME or OTHER sterile sites positive within 30 days after initial culture date?

Yes No Unknown

If yes, indicate site and date of last positive culture.

Blood, Date:_______

CSF, Date: _______

Pleural fluid, Date:_______

Peritoneal fluid, Date: _______

Pericardial fluid, Date: _______

Joint/Synovial fluid, Date: _______

Bone, Date: _______

Muscle, Date: _______

Internal body site (specify________) Date: _______

Other sterile site (specify________) Date: _______

20. Were cultures of the SAME or OTHER sterile site(s) positive within 29 days after DISC?

Yes No Unknown

If yes, indicate site and date of last positive culture.

Blood, Date:______

Bone, Date:______

CSF, Date:______

Internal body site (specify________), Date:______

Joint/Synovial fluid, Date:______

Muscle, Date:______

Pericardial fluid, Date:______

Peritoneal fluid, Date:______

Pleural fluid, Date:______

Other normally sterile site (specify____) Date:______

(Updated question number and wording, order of responses, and wording of one of the response options [other sterile site is now other normally sterile site])

17b. Date of first SA blood culture after which SA not isolated for 14 days

___/___/______

21. Date of first SA blood culture after which SA not isolated for 14 days

___/___/______

(Updated question number)

22. Susceptibility Results

Cefoxitin S R U

Oxacillin S R U

Vancomycin S I R U

Clindamycin S I R U

Trimethoprim-sulfamethoxazole S I R U

22. Susceptibility Results

Cefazolin S I R U

Nafcillin S I R U

Cefoxitin S R U

Oxacillin S R U

Vancomycin S I R U

Clindamycin S I R U

Trimethoprim-sulfamethoxazole S I R U

(Added two antimicrobial agents-Cefazolin and Nafcillin)

15. Where was the patient located on the 4th calendar day prior to the date of initial culture?

Private residence

Long term care facility

Facility ID:

Long term acute care hospital

Facility ID:

Homeless

Incarcerated

Hospital inpatient

Facility ID:

Other____________

Unknown

23. Where was the patient located on the 3rd calendar day before the DISC?

Private residence

LTCF

Facility ID:

Hospital inpatient

Facility ID:

Was patient transferred from this hospital?

Yes No Unknown

LTACH

Facility ID:

Homeless

Incarcerated

Other:­­­__________

Unknown


(Updated question number and wording, Updated order of the responses, added the response: Was patient transferred from this hospital? Yes No Unknown for patients that were indicated to be a hospital inpatient.)


14. If case is 12 months of age, type of birth hospitalization

NICU/SCN

Well baby nursery

Unknown

24. If case is 12 months of age, type of birth hospitalization

NICU/SCN

Well baby nursery

Unknown

(Updated question number)

20. Underlying conditions:

Premature birth

Birth weight _____ lb _____oz OR ______ g

Estimated gestational age ______ weeks

25. If patient <2 years of age were they born premature (<37 weeks gestation)?

Yes No Unknown

---If YES, birth weight: _____ lb _____oz OR ______ g

OR Unknown birth weight

---If YES, estimated gestational age: ______ weeks

OR Unknown gestational age


(Updated question number and wording. Added “Unknown” checkboxes for birth weight and gestational age)

10b. If patient was hospitalized, was this patient admitted to the ICU during hospitalization?

Yes No Unknown

26. Was the patient in an ICU in the 2 days before the DISC?

Yes No Unknown

---if YES, date of ICU admission: _ _-_ _-_ _ _ _

OR Date Unknown

(Updated question number and wording, broke into two questions, added date of admission)

10b. If patient was hospitalized, was this patient admitted to the ICU during hospitalization?

Yes No Unknown

27. Was the patient in an ICU on the DISC or in the 2 days after the DISC?

Yes No Unknown

---if YES, date of ICU admission: _ _-_ _-_ _ _ _

OR Date Unknown

(Updated question number and wording, broke into two questions, added date of admission)

19. Types of MSSA infection associated with culture(s)


Abscess (not skin)

Peritonitis

AV Fistula/Graft infection

Pneumonia

Bacteremia

Osteomyelitis

Bursitis

Septic Arthritis

Catheter Site Infection

Septic Emboli

Cellulitis

Septic Shock

Chronic Ulcer/Wound

Skin Abscess

Decubitus/Pressure

Ulcer

Surgical Incision

Empyema

Surgical Site (internal)

Endocarditis

Urinary Tract

Epidural abscess

Other (Specify):____

Meningitis



28. Types of MSSA infection associated with culture(s)


Abscess (not skin)

Peritonitis

AV Fistula/Graft infection

Pneumonia

Bacteremia

Osteomyelitis

Bursitis

Septic Arthritis

Catheter Site Infection

Septic Emboli

Cellulitis

Septic Shock

Chronic Ulcer/Wound

Skin Abscess

Decubitus/Pressure Ulcer

Surgical Incision

Empyema

Surgical Site (internal)

Endocarditis

Urinary Tract

Epidural abscess

Other (Specify):____

Meningitis



(Updated question number, no change to the responses)

20. Underlying Conditions

Abscess/Boil (Recurrent)

AIDS

Chronic Cognitive Deficit

Chronic Liver Disease

Chronic Pulmonary Disease

Chronic Kidney Disease

Chronic Skin Breakdown

Congestive Heart Failure

Connective Tissue Disease

Current Smoker

CVA/Stroke

Cystic fibrosis

Decubitus/Pressure Ulcer

Dementia

Diabetes

Hematologic Malignancy

Hemiplegia/Paraplegia

HIV

Influenza (within 10 days of initial culture)


IVDU

Metastatic solid tumor

Myocardial Infarct

Obesity

Other drug use

Peptic ulcer disease

Peripheral vascular disease

Premature birth

Birth weight _____ lb _____oz OR ______ g

Estimated gestational age ______ weeks

Solid tumor (non metastatic)

Other (Specify for cases 12 months of age):


29. Underlying Conditions

CHRONIC LUNG DISEASE

Cystic fibrosis

Chronic pulmonary disease

CHRONIC METABOLIC DISEASE

Diabetes mellitus

with chronic complications

CARDIOVASCULAR DISEASE

CVA/Stroke/TIA

Congenital heart disease

Congestive heart failure

Myocardial infarction

Peripheral vascular disease (PVD)

GASTROINTESTINAL DISEASE

Diverticular disease

Inflammatory Bowel disease

Peptic ulcer disease

Short gut syndrome

IMMUNOCOMPROMISED CONDITION

HIV infection

AIDS/CD4 count <200

Primary immunodeficiency

Transplant, hematopoietic stem cell

Transplant, solid organ

LIVER DISEASE

Chronic liver disease

Ascites

Cirrhosis

Hepatic encephalopathy

Variceal bleeding

Hepatitis C

Treated, in SVC

Current, chronic

MALIGNANCY

Malignancy, hematologic

Malignancy, solid organ (non-metastatic)

Malignancy, solid organ (metastatic)

NEUROLOGIC CONDITION

Cerebral palsy

Chronic cognitive deficit

Dementia

Epilepsy/seizure/ seizure disorder

Multiple sclerosis

Neuropathy

Parkinson’s Disease

Other specify:_____

PLEGIAS/PARALYSIS

Hemiplegia

Paraplegia

Quadriplegia

RENAL DISEASE

Chronic kidney disease

Lowest serum creatinine:____mg/Dl

SKIN CONDITION

Burn

Decubitus/pressure ulcer

Surgical wound

Other chronic ulcer or chronic wound


OTHER

Connective tissue disease

Obesity or morbid obesity

Pregnant

Other (specify only for cases 12 months of age):___________


(Updated question number, re-ordered options based on system and alphabet, moved 6 conditions to another location on the CRF [IVDU, Other drug use, Current smoker, Premature birth, birth weight, estimated gestational age], removed 2 conditions [abscess/boil (recurrent), influenza (within 10 days of initial culture)], and added 22 conditions [an option under diabetes for “with chronic complications”; congenital heart disease; diverticular disease; inflammatory bowel disease; cerebral palsy; epilepsy/seizure/seizure disorder; multiple sclerosis; neuropathy; Parkinson’s disease; other neurologic condition; quadriplegia; lowest serum creatinine for those with chronic kidney disease; surgical wound; other chronic ulcer or wound; primary immunodeficiency; transplant, hematopoietic stem cell; transplant, solid organ; ascites; hepatitis C; 2 options under hepatitis C: treated, in SVR and current, chronic, cirrhosis; hepatic encephalopathy; variceal bleeding]. There were minor wording changes for eight conditions [CVA/stroke to CVA/Stroke/TIA; Diabetes to Diabetes mellitus; Hematologic malignancy to Malignancy, hematologic; metastatic solid tumor to Malignancy, solid organ (metastatic); myocardial infarct to myocardial infarction; obesity to obesity or morbid obesity; peripheral vascular disease to peripheral vascular disease (PVD); solid tumor (non metastatic) to Malignancy, solid organ (non-metastatic)], one question was broken into two [Hemiplegia and paraplegia are now their own checkboxes rather than hemiplegia/paraplegia). One condition (pregnancy) was added to this question, but had previously stood as a stand-alone question (Q13).

20. Underlying Conditions

Abscess/Boil (Recurrent)

AIDS

Chronic Cognitive Deficit

Chronic Liver Disease

Chronic Pulmonary Disease

Chronic Kidney Disease

Chronic Skin Breakdown

Congestive Heart Failure

Connective Tissue Disease

Current Smoker

CVA/Stroke

Cystic fibrosis

Decubitus/Pressure Ulcer

Dementia

Diabetes

Hematologic Malignancy

Hemiplegia/Paraplegia

HIV

Influenza (within 10 days of initial culture)


IVDU

Metastatic solid tumor

Myocardial Infarct

Obesity

Other drug use

Peptic ulcer disease

Peripheral vascular disease

Premature birth

Birth weight _____ lb _____oz OR ______ g

Estimated gestational age ______ weeks

Solid tumor (non metastatic)

Other (Specify for cases 12 months of age):______


30. Substance Use

Smoking:

None

Unknown

Tobacco

Marijuana

E-nicotine delivery system



Alcohol Abuse:

No

Unknown

Yes



Other Substances (Check all that apply):

None

Unknown

Marijuana (other than smoking)

Documented use disorder

IDU Skin popping Non-IDU Unknown

Opioid, DEA schedule I (e.g., heroin)

Documented use disorder

IDU Skin popping Non-IDU Unknown

Opioid, DEA schedule II-IV (e.g., methadone, oxycodone)

Documented use disorder

IDU Skin popping Non-IDU Unknown

Cocaine or methamphetamine

Documented use disorder

IDU Skin popping Non-IDU Unknown

Other (Specify):

Documented use disorder

IDU Skin popping Non-IDU Unknown

Unknown substance

Documented use disorder

IDU Skin popping Non-IDU Unknown


The data in this section was formerly collected in the underlying conditions section (IVDU [changed to injection drug user], Current smoker [changed to smoking], and other drug use). See the highlighted conditions in the prior column.


There are six new check boxes that allow “other drug” use to be captured in more detail. These questions focus on type of drug and mode of delivery.

13.At the time of first positive culture, patient was:

Pregnant

Post-partum

Neither

Unknown

This question has been deleted. A pregnancy checkbox is now included in Q20, underlying conditions

21. Prior healthcare exposure

None Unknown

Previous document MSSA infection or colonization

If yes, Month____ Year ______

or previous state id: _________



Hospitalized within year before initial culture date

If yes, Month ____ Day ____ Year ________ Unknown

If known, Facility ID: ___________



Admitted to a LTACH within year before initial culture date

If known, Facility ID: _____________


Residence in a long-term care facility within year before initial culture date

If known, Facility ID: _____________


Surgery within year before initial culture date



If yes, list the surgeries and dates of surgery that occurred within 90 days prior to the initial culture:

Surgery

Date

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____


Central vascular catheter in place at or any time in the 2 calendar days prior to initial culture



Dialysis within year before initial culture date (hemodialysis or peritoneal dialysis)



Current chronic dialysis

Type Peritoneal Unknown

Hemodialysis

Type of vascular access

AV fistula/graft

Hemodialysis CVC

Unknown

31. Prior healthcare exposure(s)


Previous documented MSSA infection or colonization

Yes No Unknown

If yes, Month____ Year ______

or previous state id: _________


Previous hospitalization in the year before DISC

Yes No Unknown

If yes, date of discharge closed to DISC: ___/___/___

Facility ID: ___________


Overnight stay in LTACH in the year before DISC

Yes No Unknown

Facility ID: ___________


Overnight stay in LTCF in the year before DISC

Yes No Unknown

Facility ID: ___________


Surgery in the year before DISC

Yes No Unknown

If yes, list the surgeries and dates of surgery that occurred within 90 days prior to the DISC:

Surgery

Date

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____

__________________________

__-__-____


Central line in place on the DISC (up to the time of collection), or at any time in the 2 calendar days before DISC Yes No Unknown


Dialysis in the year before DISC (hemodialysis or peritoneal dialysis)

Yes No Unknown


Current chronic dialysis Yes No Unknown

Type: Hemodialysis Peritoneal Unknown

If hemodialysis, type of vascular access:

AV fistula/graft Hemodialysis central line

Unknown



(Updated question number and wording. Checkboxes were updated to yes/no/unknown responses, removing the need for None/Unknown checkboxes on prior CRF. Order of sub-questions has changed [not shown].)


18. Patient outcome

Survived

Date of discharge: __/__/____

If survived, was the patient transferred to a LTCF?

Yes No Unknown

If yes, facility ID: _________________

If survived, was the patient transferred to a LTACH?

Yes No Unknown

If yes, facility ID: _________________


Died

Date of death: __/__/____

Was MSSA cultured from a normally sterile site < calendar day 7 before death? Yes No Unknown



Unknown

32. Patient outcome

Survived

Date of discharge: __/__/____

Left against medical advice (AMA)

If survived, discharged to:

Private residence

Other

LTCF Facility ID:_____

Specify:________

LTACH Facility ID:____

Unknown



Died

Date of death: __/__/____

On the day of or in the 6 calendar days before death, was the pathogen of interest isolate from a site that meets the case definition? Yes No Unknown


Unknown


(Updated question number and wording. Collapsed two questions (If patient survived, was the patient transferred to a LTCF and If patient survived was the patient transferred to a LTACH) into a single question (If survived, discharged to) and added a checkbox for “left against medical advice” and for “date unknown” (for both date of discharge [if survived] and date of death [if died])

23. Was case first identified through audit?

Yes No Unknown

33. Was case first identified through audit?

Yes No Unknown

(Updated question number)

24. CRF status

Complete

Incomplete

Edited & Correct

Chart unavailable after 3 requests

34. CRF Status

Complete

Incomplete

Edited & Correct

Chart unavailable after 3 requests

(Updated question number)

25. Does this case have recurrent MSSA disease?

Yes No Unknown

If yes, previous (1st) state ID _______________

35. Does this case have recurrent MSSA disease?

Yes No Unknown

If yes, previous (1st) state ID ___________________

(Updated question number)

26. Date reported to EIP site

___/___/______

36. Date reported to EIP site

___/___/______

(Updated question number)

27. Initials of S.O.

__________

37. S.O. Initials

____________

(Updated question number and wording)



  1. 2018 CDI Case Report and Treatment Form

Question on 2018 Form

Question on 2019 Form

28.

Identified through audit
□ Yes
□ No


Removed

5.

DATE OF BIRTH
__ __ – __ __ – __ __ __ __


10.

DATE OF BIRTH
__ __ – __ __ – __ __ __ __
□ Unknown


6. Age

12.

Age (years)


7a.

SEX:
□ Male
□ Female


12.

Sex at birth
□ Male
□ Female
□ Unknown
□ Transgender


9.

Was patient hospitalized on the date of or in the 6 calendar days after incident C. diff+ stool collection?
...
If YES, Date of Admission:
__ __ – __ __ – __ __ __ __


15.

Was patient hospitalized on the date of or in the 6 calendar days after incident C. diff+ stool collection?
...
If YES, Date of Admission:
__ __ – __ __ – __ __ __ __
□ Unknown


10.

Where was the patient located on the 3rd calendar day before the date of incident C. diff+ stool collection?
□ Private Residence
□ LTCF
Facility ID ________________
□ Hospital Inpatient
Facility ID ______________
□ LTACH
Facility ID ______________
□ Homeless
□ Incarcerated
□ Other (specify): ______________
□ Unknown


16.

Where was the patient located on the 3rd calendar day before the date of incident C. diff+ stool collection?
□ Private Residence
□ LTCF
Facility ID ________________
□ Hospital Inpatient
Facility ID ______________
Was the patient transferred from this hospital?
□ Yes
□ No
□ Unknown
□ LTACH
Facility ID ______________
□ Homeless
□ Incarcerated
□ Other (specify): ______________
□ Unknown


8c.

Location of incident C. diff+ stool collection:
□ Outpatient
□ Emergency Room
□ Observation Unit/CDU
□ Hospital Inpatient
Facility ID ______________
□ LTCF
Facility ID ________________
□ LTACH
Facility ID ______________
□ Other (specify): ______________
□ Unknown


17.

Location of incident C. diff+ stool collection:
□ Outpatient
Facility ID ______________
□ Emergency room
□ Clinic/doctor’s office
□ Dialysis center
□ Surgery
□ Observation/Clinical decision unit
□ Other outpatient
□ Hospital Inpatient
Facility ID ______________
□ ICU
□ OR
□ Radiology
□ Other inpatient
□ LTCF
Facility ID ________________
□ LTACH
Facility ID ______________
□ Autopsy
□ Other (specify): ______________
□ Unknown


11a. Was incident C. diff+ stool collected at least 3 calendar days after the date of hospital admission?

Yes (HCFO – go to 11d)

No

18a. Was incident C. diff+ stool collected at least 3 calendar days after the date of hospital admission?

Yes (HCFO – go to 18d)

No

11b. Was incident C. diff+ stool collected at an outpatient setting for a LTCF resident, or in a LTCF or LTACH?

Yes (HCFO – go to 11d)

No

18b. Was incident C. diff+ stool collected at an outpatient setting for a LTCF resident, or in a LTCF or LTACH?

Yes (HCFO – go to 18d)

No

11c. Was the patient admitted from a LTCF or a LTACH?

Yes (HCFO – go to 11d)

No (CO - stop data abstraction here)

Facility ID: ____________________

18c. Was the patient admitted from a LTCF or a LTACH?

Yes (HCFO – go to 18d)

No (CO - stop data abstraction here)

Facility ID: ____________________

14.

Exclusion criteria for CA-CDI:
□ None
□ Unknown

Hospitalized (overnight) in the 12 weeks before the date of incident C. diff+ stool collection
Date of most recent discharge
__ __ – __ __ – __ __ __ __
□ Unknown
Facility ID _______________

Overnight stay in LTACH in the 12 weeks before the date of incident C.diff + stool collection
Facility ID _______________

Residence in LTCF in the 12 weeks before the date of incident C.diff + stool collection

Facility ID _______________


20a-20c.

Exposures to healthcare in the 12 weeks before the date of incident C. diff+ stool collection

Previous hospitalization
□ Yes
□ No
□ Unknown
If yes, date of discharge closest to date of incident C. diff+ stool collection:
__ __ – __ __ – __ __ __ __
□ Unknown
Facility ID _______________

Overnight stay in LTACH
□ Yes
□ No
□ Unknown
Facility ID _______________

Overnight stay in LTCF
□ Yes
□ No
□ Unknown

Facility ID _______________


15a.

Chronic Hemodialysis
□ Yes
□ No
□ Unknown


20d.

Chronic dialysis
□ Yes
□ No
□ Unknown
Type:
□ Hemodialysis
□ Peritoneal
□ Unknown


15b.

Surgical procedure
□ Yes
□ No
□ Unknown


20e.

Surgery
□ Yes
□ No
□ Unknown


21.

UNDERLYING CONDITIONS: (Check all that apply)
□ AIDS
□ Chronic Kidney Disease
□ CVA/Stroke
□ Diabetes
□ Hematologic Malignancy
□ Hemiplegia/Paraplegia
□ Metastatic Solid Tumor
□ Myocardial infarct
□ Peripheral Vascular Disease
□ Solid Organ Transplant
□ Solid Tumor (non metastatic)
□ Stem Cell Transplant


21.

UNDERLYING CONDITIONS: (Check all that apply)

□ AIDS/CD4 count <200
□ Chronic Kidney Disease
Lowest serum creatinine: _____ mg/dL
□ CVA/Stroke/TIA
□ Diabetes mellitus
□ [Diabetes mellitus ]with chronic complications
□ Malignancy, hematologic
□ Hemiplegia
□ Paraplegia
□ Quadriplegia
□ Malignancy, solid organ (metastatic)
□ Myocardial infarction
□ Peripheral Vascular Disease (PVD)
□ Transplant, solid organ
□ Malignancy, solid organ (non-metastatic)
□ Transplant, hematopoietic stem cell
□ Cystic fibrosis
□ Ascites
□ Cirrhosis
□ Hepatic encephalopathy
□ Variceal bleeding
Hepatitis C
[Hepatitis C] treated, in SVR
[Hepatitis C] current, chronic
□ Cerebral palsy
□ Epilepsy/seizure/seizure disorder
□ Multiple sclerosis
□ Neuropathy
□ Parkinson’s disease
□ Other [neurological condition] (specify): _______________________
□ Burn
□ Decubitus/pressure ulcer
□ Surgical wound
□ Other chronic ulcer or chronic wound
□ Other[skin condition] (specify): _______________________
□ Obesity or morbid obesity


17b.

ICU Admission (in the 2 calendar days before, the day of, or the 6 calendar days after the date of incident C. diff+ stool collection)
□ Yes
□ No
□ Unknown
If YES, Date of ICU Admission _____________
□ Unknown


26, 27

Was the patient in an ICU on the day of or in the 6 days after the date of incident C. diff+ stool collection?
□ Yes
□ No
□ Unknown
If Yes, date of ICU admission:
__ __ – __ __ – __ __ __ __
□ Unknown


18, 20.2e

RADIOGRAPHIC FINDINGS (in the 6 calendar days before, the day of, or the 6 calendar days after the date of incident C. diff+ stool collection)
□ Toxic megacolon
□ Ileus
□ Neither toxic megacolon nor ileus
□ Both toxic megacolon and ileus
□ Not Done
□ Information not available

Other findings (in the 6 calendar days before, the day of, or the 6 calendar days after the date of incident C. diff+ stool collection)
□ Toxic megacolon
□ Ileus
□ Neither toxic megacolon nor ileus
□ Both toxic megacolon and ileus
□ Information not available


28.

Toxic megacolon and ileus (in the 6 calendar days before, the day of, or the 6 calendar days after the date of incident C. diff+ stool collection)
RADIOGRAPHIC FINDINGS
□ Toxic megacolon
□ Ileus
□ Neither toxic megacolon nor ileus
□ Both toxic megacolon and ileus
□ Not Done
□ Information not available

Clinical findings
□ Toxic megacolon
□ Ileus
□ Neither toxic megacolon nor ileus
□ Both toxic megacolon and ileus
□ Information not available


17a.

Colectomy (related to CDI):
...
If YES, Date of Procedure:
__ __ – __ __ – __ __ __ __


30.

Colectomy (related to CDI):
...
If YES, Date of Procedure:
__ __ – __ __ – __ __ __ __
□ Unknown


23d.

Antimicrobial therapy ( Check all that apply)

□ Amp/sulb

Imipenem

Rifampin

Tetracycline


33d.

Antimicrobial therapy ( Check all that apply)

□Ampicillin/sulbactam

Cefixime
□ Ceftaroline

Ceftazidime/avibactam
□ Ceftizoxime
□ Ceftolozane/tazobactam

Dalbavancin
□ Delafloxacin
□ Doripenem

Fosfomycin
□ Imipenem/cilastatin
□ Meropenem/vaborbactam

Oritavancin
□ Polymyxin B
□ Polymyxin E (colistin)

Tedizolid
□ Telavancin
□ Trimethoprim


17c.

Any additional positive stool test for C. diff ≥2 and ≤8 weeks after the date of incident C. diff+ stool collection?
□ Yes
□ No
If YES, Date of first recurrent specimen: __ __ – __ __ – __ __ __ __


36.

Any recurrent C. diff episodes following this incident C. diff episode?
□ Yes
□ No
If YES, Date of first recurrent specimen: __ __ – __ __ – __ __ __ __


24.

Treatment
...
□ Probiotics (specify) ________
□ Stool transplant

Course 1...
Course 2…
Course 3…


34.

Treatment
...
Course 1...
Course 2…
Course 3…
□ Probiotics (specify) _________
□ Stool transplant



  1. 2019 HAIC Candidemia Case Report


2018 CRF Question

2019 CRF Question

15. Sex:

Female

Male

Check if transgender

15. Sex at birth:

Male Female

Unknown

Check if transgender

(Updated order of responses)

19. Race

White

Black or African American

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Unknown

19. Race (Check all that apply)

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Asian

White

Black or African American

Unknown

(Updated question number and order of responses; all response options remain the same)

22. Location of specimen collection (check one)

Hospital inpatient

Hospital Inpatient

Facility ID: _________

ICU

Surgery/OR

Radiology

Other Unit


Outpatient

Clinic/Doctor’s office

Surgery

Dialysis center

Other outpatient

Emergency Room

Observational/clinical decision unit

LTCF

Facility ID: _________

LTACH

Facility ID: _________

Autopsy

Unknown

Other (specify):

________________________


22. Location of specimen collection

Outpatient

Facility ID:_______

Emergency room

Clinic/Doctor’s office

Dialysis center

Surgery

Observational/clinical decision unit

Other outpatient

Inpatient

Facility ID: ______

ICU

OR

Radiology

Other inpatient

LTCF

Facility ID: ______

LTACH

Facility ID: ______

Autopsy

Other (specify):_______

Unknown


(Added checkboxes for headings “Outpatient” and “Inpatient”. Added a facility ID for “Outpatient” and “Inpatient”. Updated the order of responses).

25. Antifungal susceptibility testing (check here if no testing done/no test reports available):


Amphotericin B


S SDD I R NS


25. Antifungal susceptibility testing (check here if no testing done/no test reports available):


(added options “NI” and “ND” for each drug –see above for example)

Amphotericin B


S SDD I R NS NI ND


26. Additional non-Candida organisms isolated from blood cultures on the same day as DISC:

1 Yes 0 No 9 Unknown

26a. If yes, additional organisms (Enter up to 3 pathogens): ____________________, ____________________, ____________________

26. Additional non-Candida organisms isolated from blood cultures on the day of or in the 7 days before DISC:

1 Yes 0 No 9 Unknown

26a. If yes, additional organisms (Enter up to 3 pathogens): ____________________, ____________________, ____________________


27. At the time of DISC, was the patient known to be colonized with or being managed as if they were colonized with multi-drug resistant organism (MDRO) infection control (e.g.: on contact precautions)? MDROs include CRE, CRPA, CRAB, MRSA, and VRE.

1 Yes 0 No 9 Unknown

27a. If yes, specify organisms (Enter up to 3 pathogens): ____________________, ____________________, ____________________

(added new question)

29. Other known sites of Candida/yeast infection or colonization in the 7 days before or 3 days after the DISC?

(check all that apply): None Unknown

Peritoneal fluid or abdominal cavity

Urine

Respiratory specimen

Pleural fluid

CSF

Bone

Skin

Catheter tip

Other site (specify): _____________________


30. Did the patient have any of the following types of infection/colonization related to their Candida infection?

(check all that apply): None Unknown

Abscess

Splenic

Liver

Pulmonary

Candiduria

CNS involvement (meningitis, brain abscess)

Eyes (endophthalmitis or chorioretinitis)

Endocarditis

Peritonitis

Respiratory specimen with Candida

Septic emboli

Lungs

Brain

Osteomyelitis

Skin lesions

Other (specify): _____________________


(changed question number, wording slightly and changed more options)

32. Patient outcome: 1 Survived 9 Unknown

Date of discharge:

___ ___ - ___ ___ - ___ ___ ___ ___ Unknown


33. Patient outcome

Date of discharge: 1 Survived 9 Unknown

___ ___ - ___ ___ - ___ ___ ___ ___ Unknown

Left against medical advice (AMA)

(updated number and added option for left AMA)


34. Did the patient have any of the following classes or specific ICD-10 codes, including any sub-codes for this hospitalization?

(Check all that apply): None Unknown

B37 (candidiasis)

Specify sub-code: ___________________

Specify sub-code: ___________________

P37.5 (neonatal candidiasis)

B48 (other mycoses, not classified elsewhere)

B49 (unspecified mycoses)

T80.211 (BSI due to central venous catheter)

A41.9 (sepsis, unspecified organism)

R65.2 (severe sepsis)

(new question)

36. Underlying conditions (Check all that apply): None Unknown


Chronic Lung Disease

Cystic Fibrosis

Chronic Pulmonary disease

Chronic Metabolic Disease

Diabetes Mellitus

With Chronic Complications

Cardiovascular Disease

CVA/Stroke/TIA

Congenital Heart disease

Congestive Heart Failure

Myocardial infarction

Peripheral Vascular Disease (PVD)

Gastrointestinal Disease

Diverticular disease

Inflammatory Bowel Disease

Peptic Ulcer Disease

Short gut syndrome

Immunocompromised Condition

HIV infection

AIDS/CD4 count <200

Primary Immunodeficiency

Transplant, Hematopoietic Stem Cell

Transplant, Solid Organ

Chronic Liver Disease

Ascites

Chronic hepatitis C

Cirrhosis

Hepatic Encephalopathy

Variceal Bleeding


Malignancy

Malignancy, Hematologic

Malignancy, Solid Organ (non-metastatic)

Malignancy, Solid Organ (metastatic)

Neurologic Condition

Cerebral palsy

Chronic Cognitive Deficit

Dementia

Epilepsy/seizure/seizure disorder

Multiple sclerosis

Neuropathy

Parkinson’s disease

Other (specify): _________________Plegias/Paralysis

Hemiplegia

Paraplegia

Quadriplegia

Renal Disease

Chronic Kidney Disease

Lowest serum creatinine: ­­­­______________mg/DL

Skin Condition

Burn

Decubitus/Pressure Ulcer

Surgical Wound

Other chronic ulcer or chronic wound

Other skin condition

(specify): _________________

Other

Connective tissue disease

Obesity or morbid obesity

Pregnant




38. Underlying Conditions

Chronic Lung Disease

Cystic Fibrosis

Chronic Pulmonary disease

Chronic Metabolic Disease

Diabetes Mellitus

With Chronic Complications

Cardiovascular Disease

CVA/Stroke/TIA

Congenital Heart disease

Congestive Heart Failure

Myocardial infarction

Peripheral Vascular Disease (PVD)

Gastrointestinal Disease

Diverticular disease

Inflammatory Bowel Disease

Peptic Ulcer Disease

Short gut syndrome

Immunocompromised Condition

HIV infection

AIDS/CD4 count <200

Primary Immunodeficiency

Transplant, Hematopoietic Stem Cell

Transplant, Solid Organ

Liver Disease

Chronic Liver Disease

Ascites

Cirrhosis

Hepatic Encephalopathy

Variceal Bleeding

Hepatitis C

Treated, in SVR

Current, chronic

Malignancy

Malignancy, Hematologic

Malignancy, Solid Organ (non-metastatic)

Malignancy, Solid Organ (metastatic)

Neurologic Condition

Cerebral palsy

Chronic Cognitive Deficit

Dementia

Epilepsy/seizure/seizure disorder

Multiple sclerosis

Neuropathy

Parkinson’s disease

Other (specify): _________________



(Updated question number, changed wording of Hepatitis C question and added 2 options under hepatitis C: treated, in SVR and current, chronic, cirrhosis; removed “skin conditions” after “other”)

37. Social History (check all that apply): None Unknown


Smoker

E-Cigarette Use

Alcohol Abuse

Injection Drug Use

Skin Popping

Other drug use

39. Substance Use

Smoking:

None

Unknown

Tobacco

Marijuana

E-nicotine delivery system



Alcohol Abuse:

No

Unknown

Yes



Other Substances (Check all that apply):

None

Unknown

Marijuana (other than smoking)

Documented use disorder

IDU Skin popping Non-IDU Unknown

Opioid, DEA schedule I (e.g., heroin)

Documented use disorder

IDU Skin popping Non-IDU Unknown

Opioid, DEA schedule II-IV (e.g., methadone, oxycodone)

Documented use disorder

IDU Skin popping Non-IDU Unknown

Cocaine or methamphetamine

Documented use disorder

IDU Skin popping Non-IDU Unknown

Other (Specify):

Documented use disorder

IDU Skin popping Non-IDU Unknown

Unknown substance

Documented use disorder

IDU Skin popping Non-IDU Unknown



44a. If yes, date of neutropenia (mm-dd-yyyy): --

*Neutropenia: ANC ≤ 500 OR calculated as: WBC count * (% polys + % bands) ≤500

Laboratory-calculated ANC:_______ __________ * (% _____ + % ______) = _________

Removed in the new version

47. Did the patient have a CVC on the day of incident specimen collection or at any time in the 2 calendar days before DISC?


1 Yes 2 No 3 Had CVC but can’t find dates 9 Unknown


51. Did the patient have a CVC in the 2 calendar days before DISC?


1 Yes 2 No 3 Had CVC but can’t find dates 9 Unknown

(update number and changed wording of question slightly)

48. Did the patient have a midline catheter on the day of incident specimen collection or at any time in the 2 calendar days before DISC?

1 Yes 0 No 9 Unknown

52. Did the patient have a midline catheter in the 2 calendar days before DISC?

1 Yes 0 No 9 Unknown


(updated number and changed working of question slightly)



NEW QUESTION

53. Did the patient have any of the following indwelling devices present in the 3 calendar days before DISC?

Urinary Catheter

Indwelling urethral

Suprapubic

Respiratory

ET/NT

Tracheostomy

Gastrointestinal

Gastrostomy


(Added new question)



Estimated Annualized Burden Hours

As a result of proposed changes to forms highlighted in yellow, the estimated annualized burden is expected to decrease by 360 hours, from 40,349 to 39,989 and the estimated number of annual responses is shown to decrease by 8,850 from 115,600 to 106,750 responses. The changes to the amended forms have minimal to no impact on burden estimates.


The following table is updated for the entire 0920-0978 burden table. The forms included in this change request are highlighted:

Type of Respondent

Form Name

No. of respondents

No. of responses per respondent

Avg. burden per response (in hours)

Current Total Burden

After Proposed Changes

State Health Department


ABCs Case Report Form (Att. 1)

10

809

20/60

2697

2697

ABCs Invasive Pneumococcal Disease in Children Case Report Form

10

22

10/60

37


37

ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form (Att. 2)

10

6

10/60

10

10

ABCs Severe GAS Infection Supplemental Form

10

136

20/60

453

453

ABCs Neonatal Infection Expanded Tracking Form (Att. 3)

10

37

20/60

123

123

Surveillance for Non-Invasive Pneumococcal Pneumonia (SNiPP) FORM DISCONTINUED

10

125

10/60

208


0

FoodNet Campylobacter

10

850

21/60

2975

2975

FoodNet Cryptosporidium

10

130

10/60

217

217

FoodNet Cyclospora

10

3

10/60

5

5

FoodNet Listeria monocytogenes

10

13

20/60

43

43

FoodNet Salmonella

10

827

21/60

2895

2895

FoodNet Shiga toxin producing E. coli

10

190

20/60

633

633

FoodNet Shigella

10

290

10/60

483

483

FoodNet Vibrio

10

25

10/60

42

42

FoodNet Yersinia

10

30

10/60

50

50

FoodNet Hemolytic Uremic Syndrome

10

10

1

100

100

Influenza Hospitalization Surveillance Network Case Report Form (Att 4)

10

1000

25/60

4167


4167

Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (English)

10

333

5/60

278

278

Influenza Hospitalization Surveillance Project Vaccination Phone Script Consent Form (Spanish)

10

333

5/60

278

278

Influenza Hospitalization Surveillance Project Provider Vaccination History Fax Form (Children/Adults)

10

333

5/60

278

278

MuGSI Case Report Form for Carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB) (Att 5)

10

500

20/60

25/60

1667

2083

MuGSI Extended-Spectrum Beta-Lactamase-Producing Enterobacteriaceae (ESBL) (Att 6)

10

1200

20/60

25/60

4000

5000

MuGSI- Carbapenem-resistant Pseudomonas aeruginosa (CR-PA)

FORM DISCONTINUED

10

344

45/60

2580

0

Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Att 7)

10

609

474


20/60

25/60


2030

1975

Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Att 8)

10

1,035

754


20/60

25/60


3450

3142

CDI Case Report and Treatment Form (Att 9)

10

1650

30/60

35/60

8250

9625

HAIC Candidemia Case Report (Att 10)

9

800

20/60

2400

2400

TOTAL


40,349

39,989





58


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File TitleOMB CY 08
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