Crosswalk of changes 8SEP2020

Att2_EIP2021_NonSub_Crosswalk_Sept2020.docx

Emerging Infections Program

Crosswalk of changes 8SEP2020

OMB: 0920-0978

Document [docx]
Download: docx | pdf

Cross walk - 2021 form changes


ABCs


  1. 2021 ABCs Neonatal Infection Expanded Tracking Form

Current Form

Proposed changes

3C. Gestational age determined by:
1=Dates

2=Physical Exam

3=Ultrasound

9=Unknown

3C. Gestational age determined by:

1=Dates

2=Physical Exam

3=Ultrasound

4=Assisted Reproductive Technology

9=Unknown


FoodNet


  1. FoodNet Active Surveillance Data Elements List

Refer to Attachment #4 - Excel Spreadsheet – Changes are highlighted in Yellow


  1. FoodNet Diagnostic Laboratory Practices and Volume Data Elements

Refer to Attachment #5 - Excel Spreadsheet - Changes are highlighted in Yellow



FluSurv-Net


  1. FluSurv-NET Influenza Surveillance Project Case Report Form


Question on 2019-20 Form

Question on 2020-21 Form

(N/A)

COVID-NET Case ID

(N/A)

RSV-NET Case ID

(N/A)

CDC Track

C14. Where did patient reside at the time of hospitalization? (Indicate type of residence)

  • 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/Retirement home

  • Psychiatric facility

  • Other long term care facility

  • Unknown

  • Other, specify

C15. Where did patient reside at the time of hospitalization? (Indicate type of residence)

  • Private residence

  • Private residence 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/Retirement home

  • Psychiatric facility

  • Other long term care facility

  • Unknown

Other, specify

(N/A)

E2. BiPAP or CPAP use?

  • Yes

  • No

  • Unknown


(N/A)

E3. High flow nasal cannula (e.g., Vapotherm)?

  • Yes

  • No

  • Unknown

(NA

E6. Vasopressor use?

  • Yes

  • No

  • Unknown

(NA)

E7. Renal Replacement Therapy (RRT) or Dialysis?

  • Yes

  • No

  • Unknown

K2a. If patient discharged alive, please indicate to where:

  • Private residence

  • Home with services

  • Homeless/shelter

  • Nursing home/Skilled nursing facility

  • Alcohol/Drug Abuse Treatment

  • Rehabilitation facility

  • Corrections facility

  • Hospice

  • Assisted living/Residential care

  • LTACH

  • Group/Retirement home

  • Psychiatric facility

  • Other long term care facility

  • Unknown

  • Other, specify

F2. If patient discharged alive, please indicate to where:

  • 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/Retirement home

  • Psychiatric facility

  • Other long term care facility

  • Against medical advice

  • Discharged to another hospital

  • Unknown

  • Other, specify

E7. Alcohol abuse

  • Current

  • Former

  • No/Unknown


(Deleted question)

E8. Substance abuse

  • Current

  • Former

  • No/Unknown


(Deleted question)

E8a. Substance Abuse Type (Current use only) check all that apply

  • IVDU

  • Opioids

  • Cocaine

  • Methamphetamines

  • Marijuana (ingested or unknown route)

  • Unknown

  • Other, specify

(Deleted question)

E9. Current Non-Tobacco Smoker

  • Yes

  • No/Unknown

(Deleted question)

E9. Current Non-Tobacco Smoker Type

  • Marijuana

  • E-nicotine delivery system (ENDS)

  • Other

(Deleted question)

(N/A)


I1o. Hypertension

  • Yes

  • No/Unknown


E10f. Neuromuscular disorder

  • Amyotrophic lateral sclerosis (ALS)

  • Mitochondrial disorder (see list)

  • Multiple sclerosis (MS)

  • Muscular dystrophy (see list)

  • Myasthenia gravis (MG)

  • Parkinson’s disease

  • Scoliosis/Kyphoscoliosis

  • Other, specify



E10g. Neurologic disorder

  • Cerebral palsy

  • Cognitive dysfunction

  • Dementia/Alzheimer’s disease

  • Developmental delay

  • Down syndrome/Trisomy 21

  • Edwards Syndrome/Trisomy 18

  • Epilepsy/Seizure/Seizure disorder

  • Neuropathy

  • Neural tube defects/Spina bifida (See list)

  • Plegias/Paralysis/Quadriplegia

  • Traumatic brain injury (TBI)

  • Other, Specify


I1f. Neurologic Disorder

  • Amyotrophic lateral sclerosis (ALS)

  • Cerebral palsy

  • Cognitive dysfunction

  • Dementia/Alzheimer’s disease

  • Developmental delay

  • Down syndrome/Trisomy 21

  • Edward’s syndrome/Trisomy 18

  • Epilepsy/seizure/seizure disorder

  • Mitochondrial disorder (See list)

  • Multiple sclerosis (MS)

  • Muscular dystrophy (See list)

  • Myasthenia gravis (MG)

  • Neural tube defects/Spina bifida (See list)

  • Neuropathy

  • Parkinson’s disease

  • Plegias/Paralysis/Quadriplegia

  • Scoliosis/Kyphoscoliosis

  • Traumatic brain injury (TBI), history of

  • Other, specifiy

E10m. Total # of pregnancies to date


(Deleted question)


E10m. Total # of pregnancies to date that resulted in a live birth


(Deleted question)


E10m. Specify total # of fetuses for current pregnancy

  • 1

  • 2

  • 3

  • >3

  • Unknown


(Deleted question)


E10m. Specify gestational age in weeks

(Deleted question)


E10m. If gestation age in weeks unknown, specify trimester of pregnancy

  • 1st (0 to 13 weeks 6/7 days)

  • 2nd (14 weeks 0/7 days to 27 weeks 6/7 days)

  • 3rd (28 weeks 0/7 days to end)

  • Unknown

(Deleted question)


G1. Were any bacterial culture tests performed with a collection date within three days of admission?

  • Yes

  • No

  • Unknown

(Deleted question)

G2. If yes was there a positive culture for a bacterial pathogen?

  • Yes

  • No

  • Unknown

(Deleted question)

G3a. If yes, specify Pathogen 1

(Deleted question)

Gb. Date of culture

(Deleted question)

G3c. Site where pathogen identified

  • Blood

  • Bronchoalveolar lavage (BAL)

  • Pleural fluid

  • Cerebrospinal fluid (CSF)

  • Sputum

  • Endotracheal aspirate

  • Other, specify

(Deleted question)

G3d. If Staphylococcus aureus, specify

  • Methicillin resistant (MRSA)

  • Methicillin sensitive (MMSA)

  • Sensitivity unknown

(Deleted question)

H1b. Adenovirus

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

(Deleted question)

H1b. Parainfluenza 1

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

H1b. Parainfluenza 2

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

H1b. Parainfluenza 3

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

H1b. Parainfluenza 4

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

H1b. Human metapneumovirus

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

H1b. Rhinovirus/Entervirus

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

H1b. Coronavirus type

  • Yes, positive

  • Yes, negative,

  • Not tested/Unknown

  • Date

(Deleted question)

(N/A)

K1c. Coronavirus SARS-CoV-2

  • Yes, positive

  • Yes, negative

  • Not tested/Unknown

  • Date

2c. Total Duration (days)

(Deleted question)

M1. Was a chest x-ray taken within 3 days of hospitalization?

  • Yes

  • No

  • Unknown

(Deleted question)

M2. Were any of these chest x-rays abnormal?

  • Yes

  • No

  • Unknown

(Deleted question)

M2a. Date of first abnormal chest x-ray

(Deleted question)

M2b. For first abnormal chest x-ray, please check all that apply

  • Report not available

  • Air space density

  • Air space opacity

  • Bronchopneumonia/pneumonia

  • Cannot rule our pneumonia

  • Consolidation

  • Cavitation

  • ARDS( acute respiratory distress syndrome)

  • Lung infiltrate

  • Interstitial infiltrate

  • Lobar infiltrate

  • Pleural effusion/empyema

  • Other

(Deleted question)

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 kidney injury

  • 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

  • Seizsures

  • Stroke (CVA)

N1. Did the patient have any of the following new diagnoses at discharge? (check all that apply)

  • Acute encephalopathy/encephalitis

  • Acute liver failure

  • Acute myocardial infarction

  • Acute myocarditis

  • Acute renal failure/acute kidney injury

  • Acute respiratory distress syndrome (ARDS)

  • Acute respiratory failure

  • Asthma exacerbation

  • Bacteremia

  • Bronchiolitis

  • Bronchitis

  • Chronic lung disease of prematuriy/BPD

  • Congestive heart failure

  • COPD exacerbation

  • Diabetic ketoacidosis

  • Disseminated intravascular coagulation (DIC)

  • Guillain-Barre syndrome

  • Hemophagocytic syndrome

  • Invasive pulmonary aspergillosis

  • Kawasaki disease

  • Multisystem inflammatory syndrome in children (MIS-C)

  • Other thrombosis/embolism/coagulopathy

  • Pneumonia

  • Pulmonary embolism (PE)

  • Reyes syndrome

  • Rhabdomyolysis

  • Sepsis

  • Seizures

  • Stroke (CVA)

  • Toxic shock syndrome (TSS)




  1. FluSurv-NET/RSV Laboratory Survey


Question on 2019-20 form

Question on 2020-21 form

5a. Select kit name(s) (manufacturer) for all molecular assays performed at the laboratory: (Check all that apply) (https://www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html)


  • ID Now™ Influenza A&B (CLIA Waived), (Abbott)†

  • Accula Flu A/Flu B (Mesa Biotech, Inc.)†

  • ARIES® Flu A/B & RSV Assay, (Luminex)

  • CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit4), (CDC Influenza Division)

  • CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel, (CDC Influenza Division)

  • CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (CDC Influenza Division)

  • CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel, (CDC Influenza Division) Cepheid Xpert Flu Assay, (Cepheid)

  • Cepheid Xpert Flu/RSV XC Assay, (Cepheid)

  • Cepheid Xpert Express Flu Assay, (Cepheid)

  • Cepheid Xpert Express Flu/RSV Assay, (Cepheid)

  • Cobas Liat Influenza A/B, (Roche Diagnostics)†

  • Cobas Liat Influenza A/B & RSV, (Roche Diagnostics)†

  • ePlex Respiratory Pathogen Panel (GenMark Diagnostices)*

  • eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)*

  • FilmArray® Respiratory Panel, (BioFire Diagnostics, LLC)*

  • FilmArray® Respiratory Panel, EZ (BioFire Diagnostics, LLC)*

  • Idylla Respiratory IFV-RSV Panel, (Biocartis)*

  • IMDx Flu A/B and RSV for Abbott m2000, (IMDx)

  • Lyra Influenza A+B Assay, (Quidel)

  • Nx-TAG Respiratory Pathogen Panel, (Luminex Molecular Diagnostics Inc)*

  • Panther Fusion® Flu A/B RSV, (Assay Hologic)

  • Prodesse PROFLU™, (GenProbe/Hologic)

  • Prodesse ProFAST™, (GenProbe/Hologic)*

  • Silaris Infuenza A & Btg, (Sekisui Diagnostic)†

  • Solana Influenza A+B Assay, (Quidel) Simplexa™

  • Flu A/B & RSV, (Focus Diagnostics, 3M) Simplexa™

  • Flu A/B & RSV Direct, (Focus Diagnostics, 3M)

  • Simplexa™ Influenza A H1N1 (2009), (Focus Diagnostics, 3M) Verigene®

  • Respiratory Virus Nucleic Acid Test, (Nanosphere, Inc)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+), (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex)*, (Luminex)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST)*, (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • Other, specify


5a. Select kit name(s) (manufacturer) for all molecular assays performed at the laboratory: (Check all that apply) (https://www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html) Multiplex Assays Authorized for Simultaneous Detectiong of Influenza Viruses and SARS-CoV-2 by FDA: (https://www.cdc.gov/flu/professionals/diagnosis/table-flu-covid19-detection.html)


  • ID Now™ Influenza A&B (CLIA Waived), (Abbott)†

  • Accula Flu A/Flu B (Mesa Biotech, Inc.)†

  • ARIES® Flu A/B & RSV Assay, (Luminex)

  • BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)‡*

  • CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit4), (CDC Influenza Division)

  • CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel, (CDC Influenza Division)

  • CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (CDC Influenza Division)

  • CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel, (CDC Influenza Division)

  • CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (CDC Influenza Division)

  • Cepheid Xpert Flu Assay, (Cepheid)

  • Cepheid Xpert Flu/RSV XC Assay, (Cepheid)

  • Cepheid Xpert Express Flu Assay, (Cepheid)

  • Cepheid Xpert Express Flu/RSV Assay, (Cepheid)

  • Cobas Liat Influenza A/B, (Roche Diagnostics)†

  • Cobas Liat Influenza A/B & RSV, (Roche Diagnostics)†

  • ePlex Respiratory Pathogen Panel (GenMark Diagnostices)*

  • eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)*

  • FilmArray® Respiratory Panel, (BioFire Diagnostics, LLC)*

  • FilmArray® Respiratory Panel, EZ (BioFire Diagnostics, LLC)*

  • Idylla Respiratory IFV-RSV Panel, (Biocartis)*

  • IMDx Flu A/B and RSV for Abbott m2000, (IMDx)

  • Lyra Influenza A+B Assay, (Quidel)

  • Nx-TAG Respiratory Pathogen Panel, (Luminex Molecular Diagnostics Inc)*

  • Panther Fusion® Flu A/B RSV, (Assay Hologic)

  • Prodesse PROFLU™, (GenProbe/Hologic)

  • Prodesse ProFAST™, (GenProbe/Hologic)*

  • QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN)‡*

  • Silaris Infuenza A & Btg, (Sekisui Diagnostic)†

  • Solana Influenza A+B Assay, (Quidel)

  • Simplexa™ Flu A/B & RSV, (Focus Diagnostics, 3M)

  • Simplexa™ Flu A/B & RSV Direct, (Focus Diagnostics, 3M)

  • Simplexa™ Influenza A H1N1 (2009), (Focus Diagnostics, 3M)

  • Verigene® Respiratory Virus Nucleic Acid Test, (Nanosphere, Inc)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+), (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex)*, (Luminex)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST)*, (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • Other, specify

5b. If more than one kit is selected above, please select the one kit that is (or will be) used most frequently for molecular assay at the laboratory during the current influenza season.


  • ID Now™ Influenza A&B (CLIA Waived), (Abbott)†

  • Accula Flu A/Flu B (Mesa Biotech, Inc.)†

  • ARIES® Flu A/B & RSV Assay, (Luminex)

  • CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit4), (CDC Influenza Division)

  • CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel, (CDC Influenza Division)

  • CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (CDC Influenza Division)

  • CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel, (CDC Influenza Division) Cepheid Xpert Flu Assay, (Cepheid)

  • Cepheid Xpert Flu/RSV XC Assay, (Cepheid)

  • Cepheid Xpert Express Flu Assay, (Cepheid)

  • Cepheid Xpert Express Flu/RSV Assay, (Cepheid)

  • Cobas Liat Influenza A/B, (Roche Diagnostics)†

  • Cobas Liat Influenza A/B & RSV, (Roche Diagnostics)†

  • ePlex Respiratory Pathogen Panel (GenMark Diagnostices)*

  • eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)*

  • FilmArray® Respiratory Panel, (BioFire Diagnostics, LLC)*

  • FilmArray® Respiratory Panel, EZ (BioFire Diagnostics, LLC)*

  • Idylla Respiratory IFV-RSV Panel, (Biocartis)*

  • IMDx Flu A/B and RSV for Abbott m2000, (IMDx)

  • Lyra Influenza A+B Assay, (Quidel)

  • Nx-TAG Respiratory Pathogen Panel, (Luminex Molecular Diagnostics Inc)*

  • Panther Fusion® Flu A/B RSV, (Assay Hologic)

  • Prodesse PROFLU™, (GenProbe/Hologic)

  • Prodesse ProFAST™, (GenProbe/Hologic)*

  • Silaris Infuenza A & Btg, (Sekisui Diagnostic)†

  • Solana Influenza A+B Assay, (Quidel) Simplexa™

  • Flu A/B & RSV, (Focus Diagnostics, 3M) Simplexa™

  • Flu A/B & RSV Direct, (Focus Diagnostics, 3M)

  • Simplexa™ Influenza A H1N1 (2009), (Focus Diagnostics, 3M) Verigene®

  • Respiratory Virus Nucleic Acid Test, (Nanosphere, Inc)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+), (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex)*, (Luminex)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST)*, (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • Other, specify


5b. If more than one kit is selected above, please select the one kit that is (or will be) used most frequently for molecular assay at the laboratory during the current influenza season.


  • ID Now™ Influenza A&B (CLIA Waived), (Abbott)†

  • Accula Flu A/Flu B (Mesa Biotech, Inc.)†

  • ARIES® Flu A/B & RSV Assay, (Luminex)

  • BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)‡*

  • CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit4), (CDC Influenza Division)

  • CDC Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel, (CDC Influenza Division)

  • CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (CDC Influenza Division)

  • CDC Influenza 2009 A(H1N1)pdm Real-Time RT-PCR Panel, (CDC Influenza Division)

  • CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (CDC Influenza Division)

  • Cepheid Xpert Flu Assay, (Cepheid)

  • Cepheid Xpert Flu/RSV XC Assay, (Cepheid)

  • Cepheid Xpert Express Flu Assay, (Cepheid)

  • Cepheid Xpert Express Flu/RSV Assay, (Cepheid)

  • Cobas Liat Influenza A/B, (Roche Diagnostics)†

  • Cobas Liat Influenza A/B & RSV, (Roche Diagnostics)†

  • ePlex Respiratory Pathogen Panel (GenMark Diagnostices)*

  • eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)*

  • FilmArray® Respiratory Panel, (BioFire Diagnostics, LLC)*

  • FilmArray® Respiratory Panel, EZ (BioFire Diagnostics, LLC)*

  • Idylla Respiratory IFV-RSV Panel, (Biocartis)*

  • IMDx Flu A/B and RSV for Abbott m2000, (IMDx)

  • Lyra Influenza A+B Assay, (Quidel)

  • Nx-TAG Respiratory Pathogen Panel, (Luminex Molecular Diagnostics Inc)*

  • Panther Fusion® Flu A/B RSV, (Assay Hologic)

  • Prodesse PROFLU™, (GenProbe/Hologic)

  • Prodesse ProFAST™, (GenProbe/Hologic)*

  • QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN)‡*

  • Silaris Infuenza A & Btg, (Sekisui Diagnostic)†

  • Solana Influenza A+B Assay, (Quidel)

  • Simplexa™ Flu A/B & RSV, (Focus Diagnostics, 3M)

  • Simplexa™ Flu A/B & RSV Direct, (Focus Diagnostics, 3M)

  • Simplexa™ Influenza A H1N1 (2009), (Focus Diagnostics, 3M)

  • Verigene® Respiratory Virus Nucleic Acid Test, (Nanosphere, Inc)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+), (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex)*, (Luminex)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST)*, (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

Other, specify

5d. What testing kit does the testing facility use (or will use) most often to perform influenza A sub-typing during the current influenza season?

  • ePlex Respiratory Pathogen Panel (GenMark Diagnostics)

  • eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)

  • FilmArray Respiratory Panel, (BioFire Diagnostics, LLC)

  • Idylla Respiratory IFV-RSV Panel, (Biocartis)

  • Nx-TAG Respiratory Pathogen Panel (Luminex Molecular Diagnostics Inc)

  • Prodesse ProFAST™, (GenProbe/Hologic)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex), (Nanosphere, Inc)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST), (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • Other, specify

5d. What testing kit does the testing facility use (or will use) most often to perform influenza A sub-typing during the current influenza season?

  • BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LL)

  • ePlex Respiratory Pathogen Panel (GenMark Diagnostices)*

  • eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)

  • FilmArray Respiratory Panel, (BioFire Diagnostics, LLC)

  • Idylla Respiratory IFV-RSV Panel, (Biocartis)

  • Nx-TAG Respiratory Pathogen Panel (Luminex Molecular Diagnostics Inc)

  • QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex), (Nanosphere, Inc)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST), (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • Other, specify

8. Based on tests that were performed during the 2018-2019 influenza season, approximately what percent of the time are each of these test types used to test for flu overall?

  • __% Viral culture

  • __% Indirect fluorescent antibody stain (IFA)/direct fluorescent antibody stain (DFA)

  • __% Rapid influenza diagnostic test (rapid test, RIDT)

  • __% Rapid Molecular Assay

  • __% Standard Molecular Assay – singleplex or dualplex

  • __% Standard Molecular Assay – multiplex /respiratory viral panel

8. Based on tests that were performed during the 2019-2020 influenza season, approximately what percent of the time are each of these test types used to test for flu overall?

  • __% Viral culture

  • __% Indirect fluorescent antibody stain (IFA)/direct fluorescent antibody stain (DFA)

  • __% Rapid influenza diagnostic test (rapid test, RIDT)

  • __% Rapid Molecular Assay

  • __% Standard Molecular Assay – singleplex or dualplex

__% Standard Molecular Assay – multiplex /respiratory viral panel

13a. Select kit name(s) (manufacturer) for all molecular assays used at the laboratory

  • ARIES® Flu A/B & RSV Assay (Luminex)

  • Alere™ i RSV (Alere)

  • Cepheid Xpert Flu/RSV XC Assay (Cepheid)

  • Cepheid Xpert Xpress Flu/RSV Assay (Cepheid)

  • Cobas® Liat® Influenza A/B and RSV Assay (Roche Molecular Systems, Inc.)

  • eSensor® Respiratory Viral Panel (RVP) (GenMark Diagnostics)

  • FilmArray Respiratory Panel (BioFire Diagnostics LLC)

  • FilmArray Respiratory Panel EZ (BioFire Diagnostics LLC)

  • IMDx Flu A/B and RSV for Abbott m2000 (IMDx)

  • Prodesse PROFLU™+ (GenProbe/Hologic)

  • Simplexa™ Flu A/B & RSV (Focus Diagnostics, 3M)

  • Simplexa™ Flu A/B & RSV Direct (Focus Diagnostics, 3M)

  • Verigene® Respiratory Virus Nucleic Acid Test (Luminex)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex) (Luminex)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST) (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • CDC Respiratory Syncytial Virus Real-Time RT-PCR Assay

  • Other, specify

13a. Select kit name(s) (manufacturer) for all molecular assays used at the laboratory

  • ARIES® Flu A/B & RSV Assay (Luminex)

  • Alere™ I RSV (Alere)

  • Cepheid GeneXpert® Infinity-48 System (Cepheid)

  • Cepheid Xpert Flu/RSV XC Assay (Cepheid)

  • Cepheid Xpert Xpress Flu/RSV Assay (Cepheid)

  • Cobas® Liat® Influenza A/B and RSV Assay (Roche Molecular Systems, Inc.)

  • ePlex® Respiratory Pathogen Panel (GenMark Diagnostics)

  • eSensor® Respiratory Viral Panel (RVP) (GenMark Diagnostics)

  • FilmArray Respiratory Panel (BioFire Diagnostics LLC)

  • FilmArray Respiratory Panel EZ (BioFire Diagnostics LLC)

  • IMDx Flu A/B and RSV for Abbott m2000 (IMDx) NxTAG® Respiratory Pathogen Panel (Luminex Molecular Diagnostics Inc.)

  • Panther Fusion™ Flu A/B RSV (Hologic)

  • Prodesse PROFLU™+ (GenProbe/Hologic)

  • Simplexa™ Flu A/B & RSV (Focus Diagnostics, 3M)

  • Simplexa™ Flu A/B & RSV Direct (Focus Diagnostics, 3M)

  • Verigene® Respiratory Virus Nucleic Acid Test (Luminex)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex) (Luminex)

  • xTAG® Respiratory Viral Panel (RVP or RVP FAST or RVP Fast v2) (Luminex Corporation)

  • In-house developed PCR assay

  • CDC Respiratory Syncytial Virus Real-Time RT-PCR Assay

  • Other, specify

13b. If more than one kit is selected above, please select the one kit that is (or will be) used most frequently for molecular assays at the laboratory during the current RSV season (select one)


  • ARIES® Flu A/B & RSV Assay (Luminex)

  • Alere™ i RSV (Alere)

  • Cepheid Xpert Flu/RSV XC Assay (Cepheid)

  • Cepheid Xpert Xpress Flu/RSV Assay (Cepheid)

  • Cobas® Liat® Influenza A/B and RSV Assay (Roche Molecular Systems, Inc.)

  • eSensor® Respiratory Viral Panel (RVP) (GenMark Diagnostics)

  • FilmArray Respiratory Panel (BioFire Diagnostics LLC)

  • FilmArray Respiratory Panel EZ (BioFire Diagnostics LLC)

  • IMDx Flu A/B and RSV for Abbott m2000 (IMDx)

  • Prodesse PROFLU™+ (GenProbe/Hologic)

  • Simplexa™ Flu A/B & RSV (Focus Diagnostics, 3M)

  • Simplexa™ Flu A/B & RSV Direct (Focus Diagnostics, 3M)

  • Verigene® Respiratory Virus Nucleic Acid Test (Luminex)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex) (Luminex)

  • x-TAG® Respiratory Viral Panel Fast (RVP FAST) (Luminex Molecular Diagnostics Inc)

  • In-house developed PCR assay

  • CDC Respiratory Syncytial Virus Real-Time RT-PCR Assay

  • Other, specify

13b. If more than one kit is selected above, please select the one kit that is (or will be) used most frequently for molecular assays at the laboratory during the current RSV season (select one)

  • ARIES® Flu A/B & RSV Assay (Luminex)

  • Alere™ I RSV (Alere)

  • Cepheid GeneXpert® Infinity-48 System (Cepheid)

  • Cepheid Xpert Flu/RSV XC Assay (Cepheid)

  • Cepheid Xpert Xpress Flu/RSV Assay (Cepheid)

  • Cobas® Liat® Influenza A/B and RSV Assay (Roche Molecular Systems, Inc.)

  • ePlex® Respiratory Pathogen Panel (GenMark Diagnostics)

  • eSensor® Respiratory Viral Panel (RVP) (GenMark Diagnostics)

  • FilmArray Respiratory Panel (BioFire Diagnostics LLC)

  • FilmArray Respiratory Panel EZ (BioFire Diagnostics LLC)

  • IMDx Flu A/B and RSV for Abbott m2000 (IMDx) NxTAG® Respiratory Pathogen Panel (Luminex Molecular Diagnostics Inc.)

  • Panther Fusion™ Flu A/B RSV (Hologic)

  • Prodesse PROFLU™+ (GenProbe/Hologic)

  • Simplexa™ Flu A/B & RSV (Focus Diagnostics, 3M)

  • Simplexa™ Flu A/B & RSV Direct (Focus Diagnostics, 3M)

  • Verigene® Respiratory Virus Nucleic Acid Test (Luminex)

  • Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) (Luminex)

  • Verigene® Respiratory Pathogen Nucleic Acid Test (RP Flex) (Luminex)

  • xTAG® Respiratory Viral Panel (RVP or RVP FAST or RVP Fast v2) (Luminex Corporation)

  • In-house developed PCR assay

  • CDC Respiratory Syncytial Virus Real-Time RT-PCR Assay

Other, specify

18. Based on tests that were performed during the 2018-2019 RSV season, approximately what percent of the time are each of these test types used to test for RSV in pediatric patients (aged 0–17) years?

  • __% Viral culture

  • __% Indirect fluorescent antibody stain (IFA)/direct fluorescent antibody stain (DFA)

  • __% Serology (IgG or IgM)

  • __% Rapid antigen diagnostic test (rapid test, RADT)

  • __% Molecular Assay – singleplex (RSV only)

  • __% Molecular Assay – dualplex (RSV/influenza)

  • __% Molecular Assay – multiplex /respiratory viral panel (RVP)

  • Not applicable (no pediatric testing)


18. Based on tests that were performed during the 2019-2020 RSV season, approximately what percent of the time are each of these test types used to test for RSV in pediatric patients (aged 0–17) years?

  • __% Viral culture

  • __% Indirect fluorescent antibody stain (IFA)/direct fluorescent antibody stain (DFA)

  • __% Serology (IgG or IgM)

  • __% Rapid antigen diagnostic test (rapid test, RADT)

  • __% Molecular Assay – singleplex (RSV only)

  • __% Molecular Assay – dualplex (RSV/influenza)

  • __% Molecular Assay – multiplex /respiratory viral panel (RVP)

  • Not applicable (no pediatric testing)


19. Based on tests that were performed during the 2018-2019 RSV season, approximately what percent of the time are each of these test types used to test for RSV in adult patients (aged ≥18 years)?

  • __% Viral culture

  • __% Indirect fluorescent antibody stain (IFA)/direct fluorescent antibody stain (DFA)

  • __% Serology (IgG or IgM)

  • __% Rapid antigen diagnostic test (rapid test, RADT)

  • __% Molecular Assay – singleplex (RSV only)

  • __% Molecular Assay – dualplex (RSV/influenza)

  • __% Molecular Assay – multiplex /respiratory viral panel (RVP)

  • Not applicable (no adult testing)


19. Based on tests that were performed during the 2019-2020 RSV season, approximately what percent of the time are each of these test types used to test for RSV in adult patients (aged ≥18 years)?

  • __% Viral culture

  • __% Indirect fluorescent antibody stain (IFA)/direct fluorescent antibody stain (DFA)

  • __% Serology (IgG or IgM)

  • __% Rapid antigen diagnostic test (rapid test, RADT)

  • __% Molecular Assay – singleplex (RSV only)

  • __% Molecular Assay – dualplex (RSV/influenza)

  • __% Molecular Assay – multiplex /respiratory viral panel (RVP)

  • Not applicable (no adult testing)





HAIC


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

Note: Changes on the 2021 CRF are highlighted in yellow.

Question on 2020 form

Question on 2021 form

Title: 2020 Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem Resistant A. baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

Title: 2021 Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem Resistant A. baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

11. Incident specimen collection site

Blood

Bone

CSF

Internal body site (specify):_____________

Joint/synovial fluid

Muscle

Peritoneal fluid

Pericardial fluid

Pleural fluid

Urine

Other normally sterile site (specify):______________

11. Incident specimen collection site

Blood

Bone

Bronchoalveolar lavage (CRAB only, complete Q23c)

CSF

Internal body site (specify):_____________

Joint/synovial fluid

Muscle

Peritoneal fluid

Pericardial fluid

Pleural fluid

Sputum (CRAB only, complete Q23c)

Tracheal aspirate (CRAB only, complete Q23c)

Urine

Wound (specify):______________ (CRAB only)

Other LRT site (specify):______________ (CRAB only, complete Q23c)

Other normally sterile site (specify):______________

11. Incident specimen collection site

Abscess, not skin

AV fistula/graft infection

Bacteremia

Bursitis

Catheter site infection (CVC)

Cellulitis

Chronic ulcer/wound (not decubitus)

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):_______________


11. Incident specimen collection site

Abscess, not skin

AV fistula/graft infection

Bacteremia

Bursitis

Catheter site infection (CVC)

Cellulitis

Chronic ulcer/wound (not decubitus)

Empyema

Endocarditis

Epidural abscess

Meningitis

Osteomyelitis

Peritonitis

Pneumonia (CRAB cases, complete Q23c)

Pyelonephritis

Septic arthritis

Septic emboli

Septic shock

Skin abscess

Surgical incision infection

Surgical site infection (internal)

Traumatic wound

Urinary tract infection

Other (specify):_______________


22d. Urine culture only: 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


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

Peritoneal fluid

Pericardial fluid

Pleural fluid

Urine

Other normally sterile site (specify):______________


26. Enterobacteriaceae only: Were cultures of sterile site(s) or urine positive for a different organism (Q10) in the 30 days before the DISC?

Yes

No

Unknown

N/A

If yes, source (check all that apply):

Blood

Bone

CSF

Internal body site (specify):_____________

Joint/synovial fluid

Muscle

Peritoneal fluid

Pericardial fluid

Pleural fluid

Urine

Other normally sterile site (specify):______________


If yes, indicate organism and associated state ID for the incident closest to the DISC:

Escherichia coli

Enterobacter cloacae

Klebsiella aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca


27a. A. baumannii cultures only: Was cultures of other sterile site(s) or urine positive for another A. baumannii in in the 30 days after the DISC?

Yes

No

Unknown

N/A

If yes, source (check all that apply):

Blood

Bone

CSF

Internal body site (specify):_____________

Joint/synovial fluid

Muscle

Peritoneal fluid

Pericardial fluid

Pleural fluid

Urine

Other normally sterile site (specify):______________

If yes, state ID for the incident case closest to the DISC:________


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

23a. 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

23b. 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


Complete question 23c ONLY for A. baumannii cases from LRT site cultures or for non-LRT cultures where pneumonia is marked in question 17a.


23c. Chest Radiology Findings (check all that apply):

Not done

No report available

Acute respiratory distress syndrome (ARDS)

Air Space density/opacity

Ground glass opacities/infiltrates

Bronchopneumonia/pneumonia

Cannot rule out pneumonia

Cavitation

Consolidation

Infiltrate

Pleural effusion

Nodules

28a. Was the patient positive for the same organism in the year before the DISC?

Yes

No

Unknown


28b. If yes, specify date of culture and state ID for the first positive culture in the year before:

Date of culture: __/__/____

State ID:_________


29a. Enterobacteriaceae only: Was the patient positive for a MuGSI Enterobacteriaceae in the year before the DISC?

Yes

No

Unknown


29b. If yes, specify organism, date of culture, and state ID for the first positive Enterobacteriaceae culture in the year before the DISC:

Escherichia coli

Enterobacter cloacae

Klebsiella aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca


Date of culture: __/__/____


State ID:_______________



30a. Did the patient have a positive test(s) for SARS-Cov-2 (molecular assay, serology or other confirmatory test) on or before the DISC?

Yes

No

Unknown

24a. Did the patient have a positive test(s) for SARS-Cov-2 (molecular assay, serology or other confirmatory test) on or before the DISC?

Yes

No

Unknown

30b. If yes, complete table below



Specimen Collection date

Test Type

FIRST positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Serology

Unknown

Other (specify)

MOST RECENT positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Serology

Unknown

Other (specify)


24b. If yes, complete table below



Specimen Collection date

Test Type

FIRST positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Antigen

Serology

Unknown

Other (specify)

MOST RECENT positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Antigen

Serology

Unknown

Other (specify)


30c. COVID-NET Case ID:_______________

24c. COVID-NET Case ID:_______________

30d. NNDSS IDs (Please provide at least one of the following when applicable):

Local Case ID: _____________

Local Record ID: _____________

State Case Identifier: _____________

Legacy Case Identifier: _____________

24d. NNDSS IDs (Please provide at least one of the following when applicable):

Local Case ID: _____________

Local Record ID: _____________

State Case Identifier: _____________

Legacy Case Identifier: _____________

CDC 2019-nCOV ID: _____________

23. Was the incident specimen polymicrobial?

Yes

No

Unknown

25. Was the incident specimen polymicrobial?

Yes

No

Unknown

24a. Was the incident specimen tested for carbapenemase?

Yes

No

Laboratory not testing

Unknown

26a. 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 Inactivation Method (CIM)

Disk Diffusion/ROSCO Disk

E-test

Modified Carbapenemase Inactivation 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

Streck ARM-D

Other (specify):________________

Unknown

26b. If yes, what testing method was used (check all that apply)

Non-Molecular Tests:

CarbaNP

Carbapenemase Inactivation Method (CIM)

Disk Diffusion/ROSCO Disk

E-test

Modified Carbapenemase Inactivation 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

Streck ARM-D

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

Other

Specify:______________

Pos

Neg

Ind

Unk


26c. 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

Other

Specify:______________

Pos

Neg

Ind

Unk



31. Susceptibility results


Antibiotic

Amikacin

Amoxicillin/Clavulanate

Ampicillin

Ampicillin/Sulbactam

Aztreonam

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftazidime

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Ceftriaxone

Cephalothin

Ciprofloxacin

Colistin

Doripenem

Doxycycline

Ertapenem

Fosfomycin

Gentamicin

Imipenem

Imipenem-relebactam

Levofloxacin

Meropenem

Meropenem-vaborbactam

Minocycline

Nitrofurantoin

Piperacillin/Tazobactam

Plazomicin

Polymyxin B

Rifampin

Tetracycline

Tigecycline

Tobramycin

Trimethoprim-sulfamethoxazole


Data source

Medical record

Microscan

Vitek

Phoenix

Kirby-Bauer

E-test

27. Susceptibility results


Antibiotic

Amikacin

Amoxicillin/Clavulanate

Ampicillin

Ampicillin/Sulbactam

Aztreonam

Cefazolin

Cefepime

Cefiderocol

Cefotaxime

Cefoxitin

Ceftazidime

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Ceftriaxone

Cephalothin

Ciprofloxacin

Colistin

Doripenem

Doxycycline

Eravacycline

Ertapenem

Fosfomycin

Gentamicin

Imipenem

Imipenem-relebactam

Levofloxacin

Meropenem

Meropenem-vaborbactam

Minocycline

Nitrofurantoin

Omadacycline

Piperacillin/Tazobactam

Plazomicin

Polymyxin B

Rifampin

Tetracycline

Tigecycline

Tobramycin

Trimethoprim-sulfamethoxazole


Data source

Medical record

Microscan

Vitek

Phoenix

Sensititre

Kirby-Bauer

E-test

32a. Was case first identified through audit?

Yes

No

28a. Was case first identified through audit?

Yes

No

32b. CRF status

Complete

Pending

Chart unavailable after 3 requests

28b. CRF status

Complete

Pending

Chart unavailable after 3 requests

28c. SO Initials: __________________

28c. SO Initials: __________________

31d. Date of abstraction:

___ ___ - ___ ___ - ___ ___ ___ ___


28d. Date of abstraction:

___ ___ - ___ ___ - ___ ___ ___ ___


31e. Comments: __________________________________

______________________

28e. Comments: __________________________________

_________________________________________________




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

Note: Changes on the 2021 CRF are highlighted in yellow.

Question on 2020 form

Question on 2021 form

Title: 2020 Carbapenem Resistant Enterobacteriaceae (CRE)/ Carbapenem Resistant A. baumannii (CRAB) Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

Title: 2021 Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteriaceae Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare Associated Infection Community Interface (HAIC) Case Report

26a. Is antimicrobial use (IV or oral) in the 30 days before the DISC documented?

Yes

No

Unknown

24a. Is antimicrobial use (IV or oral) in the 30 days before the DISC documented?

Yes

No

Unknown

26b. If yes, check all antimicrobials used in the 30 days before the DISC

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): _____________________

24b. If yes, check all antimicrobials used in the 30 days before the DISC

Amikacin

Amoxicillin

Amoxicillin/clavulanic acid

Ampicillin

Ampicillin/sulbactam

Azithromycin

Aztreonam

Cefazolin

Cefdinir

Cefepime

Cefiderocol

Cefixime

Cefotaxime

Cefoxitin

Cefpodoxime

Ceftaroline

Ceftazidime

Ceftazidime/avibactam

Ceftizoxime

Ceftolozane/tazobactam

Ceftriaxone

Cefuroxime

Cephalexin

Ciprofloxacin

Clarithromycin

Clindamycin

Dalbavancin

Daptomycin

Delafloxacin

Doripenem

Doxycycline

Ertapenem

Eravacycline

Fidaxomicin

Fosfomycin

Gentamicin

Imipenem/cilastatin

Levofloxacin

Linezolid

Meropenem

Meropenem/vaborbactam

Metronidazole

Moxifloxacin

Nitrofurantoin

Omadacycline

Oritavancin

Penicillin

Piperacillin/tazobactam

Polymyxin B

Polymyxin E (colistin)

Rifaximin

Tedizolid

Telavancin

Tigecycline

Tobramycin

Trimethoprim

Trimethoprim/sulfamethoxazole

Vancomycin IV PO

Other (specify): _____________________

Other (specify): _____________________

24a. Did the patient have a positive test(s) for SARS-Cov-2 (molecular assay, serology or other confirmatory test) on or before the DISC?

Yes

No

Unknown

25a. Did the patient have a positive test(s) for SARS-Cov-2 (molecular assay, serology or other confirmatory test) on or before the DISC?

Yes

No

Unknown

24b. If yes, complete table below



Specimen Collection date

Test Type

FIRST positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Serology

Unknown

Other (specify)

MOST RECENT positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Serology

Unknown

Other (specify)


25b. If yes, complete table below



Specimen Collection date

Test Type

FIRST positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Antigen

Serology

Unknown

Other (specify)

MOST RECENT positive test for SARS-Cov-2 on or before the DISC:

__/__/____

Unknown

Molecular assay

Antigen

Serology

Unknown

Other (specify)


24c. COVID-NET Case ID: _____________

25c. COVID-NET Case ID: _____________

24d. NNDSS IDs (Please provide at least one of the following when applicable):

Local Case ID: _____________

Local Record ID: _____________

State Case Identifier: _____________

Legacy Case Identifier: _____________

25d. NNDSS IDs (Please provide at least one of the following when applicable):

Local Case ID: _____________

Local Record ID: _____________

State Case Identifier: _____________

Legacy Case Identifier: _____________

CDC 2019-nCOV ID: _____________

25a. Was the incident specimen polymicrobial?

Yes

No

Unknown

26a. Was the incident specimen polymicrobial?

Yes

No

Unknown

25b. What screening/confirmatory method was used for ESBL identification?

None

Unknown

Broth microdilution (ATI detection)

ESBL well

Expert rule (ATI flag)

Unknown

Broth Microdilution (Manual)

Disk Diffusion

E-test

Molecular test (specify)

Other non-molecular test (specify)

26b. What screening/confirmatory method was used for ESBL identification?

None

Unknown

Broth microdilution (ATI detection)

ESBL well

Expert rule (ATI flag)

Unknown

Broth Microdilution (Manual)

Disk Diffusion

E-test

Molecular test (specify)

Other non-molecular test (specify)

25c. If screening/confirmatory method was used, what was the result?

Positive

Negative

Indeterminate

Unknown


26c. If screening/confirmatory method was used, what was the result?

Positive

Negative

Indeterminate

Unknown


27. Susceptibility results


Antibiotic

Amikacin

Amoxicillin/Clavulanate

Ampicillin

Ampicillin/Sulbactam

Aztreonam

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftazidime

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Ceftriaxone

Cephalothin

Ciprofloxacin

Colistin

Doripenem

Doxycycline

Ertapenem

Fosfomycin

Gentamicin

Imipenem

Imipenem-relebactam

Levofloxacin

Meropenem

Meropenem-vaborbactam

Minocycline

Nitrofurantoin

Piperacillin/Tazobactam

Plazomicin

Polymyxin B

Rifampin

Tetracycline

Tigecycline

Tobramycin

Trimethoprim-sulfamethoxazole


Data source

Medical record

Microscan

Vitek

Phoenix

Kirby-Bauer

E-test

27. Susceptibility results


Antibiotic

Amikacin

Amoxicillin/Clavulanate

Ampicillin

Ampicillin/Sulbactam

Aztreonam

Cefazolin

Cefepime

Cefiderocol

Cefotaxime

Cefoxitin

Ceftazidime

Ceftazidime/Avibactam

Ceftolozane/Tazobactam

Ceftriaxone

Cephalothin

Ciprofloxacin

Colistin

Doripenem

Doxycycline

Eravacycline

Ertapenem

Fosfomycin

Gentamicin

Imipenem

Imipenem-relebactam

Levofloxacin

Meropenem

Meropenem-vaborbactam

Minocycline

Nitrofurantoin

Omadacycline

Piperacillin/Tazobactam

Plazomicin

Polymyxin B

Rifampin

Tetracycline

Tigecycline

Tobramycin

Trimethoprim-sulfamethoxazole


Data source

Medical record

Microscan

Vitek

Phoenix

Sensititre

Kirby-Bauer

E-test





  1. Invasive MRSA Infection Case Report Form

2020 Paper CRF Question

Changes to the 2020 Paper CRF Question

34a. NNDSS IDs (please provide at least one of the following when applicable):

Local case ID:_____________

Local record ID:___________

State case Identifier:________

Legacy case identifier:_____________

34a. NNDSS IDs (please provide at least one of the following when applicable):

CDC 2019 NCOV ID:_____________ (new data collection)

Local case ID:_______________

Local record ID:________________

State case Identifier:______________

Legacy case identifier:_____________



  1. Invasive MSSA Infections Case Report Form

2020 Paper CRF Question

Changes to the 2020 Paper CRF Question

34a. NNDSS IDs (please provide at least one of the following when applicable):

Local case ID:_____________

Local record ID:___________

State case Identifier:________

Legacy case identifier:_____________

34a. NNDSS IDs (please provide at least one of the following when applicable):

CDC 2019 NCOV ID:_____________ (new data collection)

Local case ID:_______________

Local record ID:________________

State case Identifier:______________

Legacy case identifier:_____________





  1. CDI Case Report Form and Treatment Form

2020 CRF

2021 CRF

9. Positive diagnostic assay for C.diff

9. Diagnostic assay for C.diff

(Reworded question. Change was noted on last year’s application but mistakenly not changed on the CRF. Response options remain the same)


40a. FIRST positive test for SARS-CoV-2 on or before the DISC – Test type

  • Molecular assay

  • Serology

  • Unknown

  • Other, specify

40a. FIRST positive test for SARS-CoV-2 on or before the DISC – Test type

  • Antigen

  • Molecular assay

  • Serology

  • Unknown

  • Other, specify

(Added antigen as a response option, previously captured as “other”)

40a. Most recent positive test for SARS-CoV-2 on or before the DISC – Test type

  • Molecular assay

  • Serology

  • Unknown

  • Other, specify

40a. Most recent positive test for SARS-CoV-2 on or before the DISC – Test type

  • Antigen

  • Molecular assay

  • Serology

  • Unknown

  • Other, specify

(Added antigen as a response option, previously captured as “other”)

41b. NNDSS IDs (please provide at least one of the following when applicable):

Local Case ID:

Local Record ID:

State case identifier:

Legacy case identifier:

41b. NNDSS IDs (please provide at least one of the following when applicable):

Local Case ID:

Local Record ID:

State case identifier:

Legacy case identifier:

CDC 2019-nCOV ID:

(Added one more NNDSS ID)



  1. Annual Survey of Laboratory Testing Practices for C. difficile Infections

Existing question

Modified question

[Section 1] Was this lab audited in 2019?

[Section 1] Was this lab audited in 2020?

(changed year to 2020 to reflect change in survey year)

[Section 2] 5. What are the testing codes associated with the tests your lab currently uses?

[Section 2] 5. What are the LOINC or internal testing codes associated with the tests your lab currently uses (e.g. LOINC codes 13957-6, 34713-8, or 54067-4)?

(Clarified that we’re asking for LOINC or internal testing codes; added examples of LOINC codes)

[Section 2] 6. Has your lab testing algorithm for C. difficile changed since January 1, 2019?


[Section 2] 6. Has your lab testing algorithm for C. difficile changed since January 1, 2020?

(changed year to 2020 to reflect change in survey year)

[Section 2] 7a. Has your rejection policy for stool specimens changed since January 1, 2019?

[Section 2] 7a. Has your rejection policy for stool specimens changed since January 1, 2020?

(changed year to 2020 to reflect change in survey year)



  1. HAIC Candidemia Case Report

2020 CRF Question

2021 CRF Question

CANDIDEMIA 2020 CASE REPORT FORM (header)


CANDIDEMIA 2021 CASE REPORT FORM (header)

(changed year)

Version: Short Form 2020, Last Updated: 07/9/2019 (footnotes)


Version: Short Form 2021, Last Updated: 07/21/2020 (footnotes)

(changed year and date)

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





Interpretation

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND

S SDD I R NS NI ND



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



(removed “NS” as an option)

Interpretation

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND

S SDD I R NI ND



26. Additional non-Candida organisms isolated from blood cultures on the day of or in the 6 days before the DISC:



1 Yes 0 No 9 Unknown





29. Additional non-Candida organisms isolated from blood cultures on the day of or in the 6 days before the DISC:



1 Yes 0 No 9 Unknown



(changed question number)

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



29a. If yes, additional organisms (Enter up to 3 pathogens): ____________________, ____________________, ____________________



(changed question number)

27. Infection with Clostridioides difficile in the 90 days before or 30 days after the DISC:



1 Yes 0 No 9 Unknown

30. Infection with Clostridioides difficile on the day of or in the 89 days before or 29 days after the DISC:



1 Yes 0 No 9 Unknown



(changed question number and updated wording)

27a. If yes, date of first C. diff diagnosis:

___ ___ - ___ ___ - ___ ___ ___ ___ Unknown



30a. If yes, date of first C. diff diagnosis:

___ ___ - ___ ___ - ___ ___ ___ ___ Unknown



(changed quesiton number)

28. Any subsequent positive Candida blood cultures in the 29 days after, not including the DISC?

1 Yes 0 No 9 Unknown

26. Any subsequent positive Candida blood cultures in the 29 days after, not including the DISC?



1 Yes 0 No 9 Unknown



(changed question number)

28a. If yes, provide dates of all subsequent positive Candida blood cultures and select the species:



26a. If yes, provide dates of all subsequent positive Candida blood cultures and select the species:



(changed question number)

29. Documented negative Candida blood culture on the day of or in the 29 days after the DISC?



1 Yes 0 No 9 Unknown



27. Documented negative Candida blood culture on the day of or in the 29 days after the DISC (in which no blood cultures after this negative culture were positive in the 29 days after the DISC)?



1 Yes 0 No 9 Unknown



(changed question number and updated the wording)

29a. If yes, date of negative blood culture:

___ ___ - ___ ___ - ___ ___ ___ ___



27a. If yes, date of negative blood culture:

___ ___ - ___ ___ - ___ ___ ___ ___



(changed question number)

New question for 2021

28. On the day of or in the 6 days before the DISC, was the patient known to be colonized with or being managed as if they were colonized with a multi-drug resistant organism (MDRO) (e.g., on contact precautions)? MDROs include CRE, CRPA, CRAB, MRSA, and VRE.

1 Yes 0 No 9 Unknown



(new data collection)

New question for 2021

28a. If yes, specify organisms (Enter up to 3 pathogens): ____________________, ____________________, ____________________



(new data collection)

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

Other (specify): _____________

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): ______________________

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

(check all that apply): None Unknown



Abdominal (new data collection)

Hepatobiliary or pancreatic (new data collection)

GI tract (new data collection)

Abscess (specify): _________ (new data collection)

Peritonitis/peritoneal fluid (new data collection)

Splenic (new data collection)

Candiduria

Esophagitis (new data collection)

Oral/thrush (new data collection)

Osteomyelitis

Skin lesions/wounds

Pulmonary (new data collection)

Abscess (new data collection)

Respiratory specimen with Candida (new data collection)

CNS involvement (meningitis, brain abscess)

Eyes (endophthalmitis or chorioretinitis)

Endocarditis

Septic emboli (specify location): _________ (new data collection)

Other (specify): __________



(changed question number, reorganized response options, removed some response options, new data collection for some response options)

31. Was the patient hospitalized on the day of or in the 6 days after the DISC?



1 Yes 0 No 9 Unknown

32. Was the patient hospitalized on the day of or in the 6 days after the DISC?



1 Yes 0 No 9 Unknown

(changed question number)

31a. If yes,

Date of first admission:

___ ___ - ___ ___ - ___ ___ ___ ___ Unknown



Hospital ID: _________________ Unknown



32a. If yes,

Date of first admission:

___ ___ - ___ ___ - ___ ___ ___ ___ Unknown



Hospital ID: _________________ Unknown



(changed question number)

31b. Was the patient transferred during this hospitalization?

1 Yes 0 No 9 Unknown



If yes, enter up to two transfers:

Date of transfer: ___ ___ - ___ ___ - ___ ___ ___ ___ Unknown

Hospital ID: _________________ Unknown



Date of second transfer: ___ ___ - ___ ___ - ___ ___ ___ ___ Unknown

Hospital ID: _________________ Unknown



32b. Was the patient transferred during this hospitalization?

1 Yes 0 No 9 Unknown



If yes, enter up to two transfers:

Date of transfer: ___ ___ - ___ ___ - ___ ___ ___ ___ Unknown

Hospital ID: _________________ Unknown



Date of second transfer: ___ ___ - ___ ___ - ___ ___ ___ ___ Unknown

Hospital ID: _________________ Unknown



(changed question number)

32. Where was the patient located prior to admission?



1 Private residence

3 LTCF

Facility ID: ____________

4 LTACH

Facility ID: _____________

5 Homeless

6 Incarcerated

7 Other (specify): ______________________

9 Unknown



32c. Where was the patient located prior to admission or, if not hospitalized, where was the patient located on the 3rd calendar day before the DISC? (Check one)



1 Private residence

2 Hospital inpatient (new option)

Facility ID: ___________

3 LTCF

Facility ID: ____________

4 LTACH

Facility ID: _____________

5 Homeless

6 Incarcerated

7 Other (specify): ______________________

9 Unknown



(changed question number, clarified the wording of the question and added a new location option)

40. Underlying conditions (Check all that apply):



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

Unknown or not done

Skin Condition

Burn

Decubitus/Pressure Ulcer

Surgical Wound

Other chronic ulcer or chronic wound

Other (specify): _________________

Other

Connective tissue disease

Obesity or morbid obesity

Pregnant



40. Underlying conditions (Check all that apply):



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 B, chronic (new option)

Hepatitis C

Treated, in SVR

Current, chronic

Hepatitis B, acute (new option)

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

Unknown or not done

Skin Condition

Burn

Decubitus/Pressure Ulcer

Surgical Wound

Other chronic ulcer or chronic wound

Other (specify): _________________

Other

Connective tissue disease

Obesity or morbid obesity

Pregnant



(added 2 new options for hepatitis indication under ‘liver disease’)

47. Surgeries on the day of or in the 89 days before the DISC:



Abdominal surgery

Non-abdominal surgery (specify): __________________

No surgery

47. Surgeries in the 90 days before, not including the DISC:



Abdominal surgery (specify): _________________

If yes: 1 Open abdomen

0 Laparoscopic

9 Unknown

Non-abdominal surgery (specify): __________________

No surgery



(changed the question wording, added specification for “Abdominal surgery” and check box options under “Abdominal surgery” which is a new data collection)

48. Pancreatitis on the day of or in the 89 days before the DISC:



1 Yes

0 No

9 Unknown

48. Pancreatitis in the 90 days before, not including the DISC:



1 Yes

0 No

9 Unknown



(changed the question wording)

49a. If yes, did the patient have any urinary tract procedures on the day of or in the 89 days before the DISC?



1 Yes 0 No 9 Unknown

49a. If yes, did the patient have any urinary tract procedures in the 90 days before, not including the DISC?



1 Yes 0 No 9 Unknown



(changed the question wording)

53. Did the patient have any of the following indwelling devices present in the 2 calendar days before, not including the DISC?



None

Unknown

Urinary Catheter/Device

Indwelling urethral

Suprapubic

Respiratory

ET/NT

Tracheostomy

Gastrointestinal

Abdominal drain (specify): _________________

Gastrostomy

53. Did the patient have any of the following indwelling devices or other devices present in the 2 calendar days before, not including the DISC?



None

Unknown

Urinary Catheter/Device

Indwelling urethral

Suprapubic

Respiratory

ET/NT

Tracheostomy

Invasive mechanical ventilation (new data collection)

Gastrointestinal

Abdominal drain (specify): _________________

Gastrostomy



(changed question wording, added a check box for this question)

New question for 2021

55. Did the patient receive any systemic steroids in the 30 days before, not including the DISC?



1 Yes 0 No 9 Unknown



(new question)

55. Did the patient receive total parenteral nutrition (TPN) in the 14 days before, not including the DISC?



1 Yes 0 No 9 Unknown



56. Did the patient receive total parenteral nutrition (TPN) in the 14 days before, not including the DISC?



1 Yes 0 No 9 Unknown



(changed the question number)

56. Did the patient receive systemic antifungal medication on the day of or in the 13 days before the DISC?



1 Yes (if Yes, fill out question 59) 0 No 9 Unknown



57. Did the patient receive systemic antifungal medication on the day of or in the 13 days before the DISC?



1 Yes (if Yes, fill out question 60) 0 No 9 Unknown



(changed the question number)

57. Was the patient administered systemic antifungal medication after, not including the DISC?



1 Yes (if Yes, fill out question 59) 0 No 9 Unknown



58. Was the patient administered systemic antifungal medication after, not including the DISC?



1 Yes (if Yes, fill out question 60) 0 No 9 Unknown



(changed the question number)

58. If antifungal medication was not given to treat current candidemia infection, what was the reason?



1 Patient died before culture result available to clinicians

2 Comfort care only measures were instituted

3 Patient discharged before culture result available to clinician

4 Medical records indicated culture result not clinically significant

5 Other reason documented in medical records, specify:

______________

6 Patient refused treatment against medical advice

9 Unknown

59. If antifungal medication was not given to treat current candidemia infection, what was the reason?

1 Patient died before culture result available to clinicians

2 Comfort care only measures were instituted

3 Patient discharged before culture result available to clinician

4 Medical records indicated culture result not clinically significant or contaminated

5 Other reason documented in medical records, specify:

______________

6 Patient refused treatment against medical advice

9 Unknown



(changed question number, added additional clarification to one response)

59. ANTIFUNGAL MEDICATION



60. ANTIFUNGAL MEDICATION



(changed question number)

New question for 2021

61. Does the chart indicate that the incident specimen was considered a contaminant or was considered to not be indicative of true of infection?



1 Yes 0 No 9 Unknown



(new question)

New question for 2021

62. Was the patient under the care of an infectious disease physician on the day of the DISC or within the 6 days after the DISC?



1 Yes 0 No 9 Unknown



(new question)

New question for 2021

1. Did the patient have a positive SARS-CoV-2 test result (molecular assay, serology, or other confirmatory test) from a specimen collected in the 30 days before the DISC or on the DISC?



1 Yes 0 No 9 Unknown



(new question)

New question for 2021

1a. If yes, date of specimen collection for initial positive SARS-CoV-2 test:



Date: ________ 9 Date Unknown



(new question)

New question for 2021

1b. If yes, EIP COVID-NET Case ID: ____________

9 Unknown Out of EIP COVID-NET catchment area



(new question)

New question for 2021

2. Did the patient receive invasive mechanical ventilation in the 30 days before the DISC, not including the DISC?



1 Yes 0 No 9 Unknown



(new question)

New question for 2021

3. Did the patient receive dialysis or renal replacement therapy (RRT) in the 30 days before the DISC, not including the DISC?



1 Yes 0 No 9 Unknown



(new question)

New question for 2021

4. If patient received any systemic steroids in the 30 days before the DISC, not including the DISC (question 55), are any of the following scenarios true? (check all that apply)

Steroid(s) given as an outpatient medication

Steroid(s) given during hospitalization associated

with candidemia episode prior to Candida DISC

Steroid(s) given as part of treatment/management

for COVID-19



(new question)

New question for 2021

5. Did the patient receive any of the following immunomodulatory drugs in the 30 days before the DISC, not including the DISC? (check all that apply)



None Tocilizumab Sarilumab

Baricitinib Unknown



(new question)

New question for 2021

5a. If yes (and patient had a positive SARS-CoV-2 test), were any of the immunomodulatory drugs given as part of treatment/management for COVID-19?



1 Yes 0 No 9 Unknown



(new question)



  1. Laboratory Testing Practices for Candidemia Questionnaire

2020 CRF Question

2021 CRF Question

2020 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE (header)


2021 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE (header)



(changed year)

New Question

  1. Does this laboratory offer yeast identification either onsite or sent to another laboratory?

Yes

No (----- If No, SKIP TO QUESTION 15 -----)

Unknown (is there another laboratory staff

member who can assist with the

questionnaire?)



(new data collection)

New Question

  1. Where is yeast identification done? (check the most applicable)

On-site, in the laboratory

Sent to commercial lab

Sent to affiliated hospital lab

Sent to other local/regional, non-affiliated reference or public health laboratory

Other ______________________________

Unknown



(new data collection)

New Instructions

Answer the following questions for the lab selected in question 8.

7) How does your lab identify yeast? (check all that apply)

MALDI-TOF Bruker (Biotyper)

MALDI-TOF bioMerieux (VITEK MS)

VITEK 2

API 20C

DNA sequencing

PNA-FISH

BactiCard Candida

BD Phoenix

MicroScan

RapID Plus

Other (specify) ______________________

Unknown

  1. How does this lab identify yeast? (check all that apply)

MALDI-TOF Bruker (Biotyper)

MALDI-TOF bioMerieux (VITEK MS)

VITEK 2

API 20C

DNA sequencing

PNA-FISH

BactiCard Candida

BD Phoenix

MicroScan

RapID Plus

Other (specify) ______________________

Unknown



(changed question number, updated question wording)

8) Does your laboratory routinely use Chromagar for the identification or differentiation of Candida isolates?

Yes

No

Unknown

  1. Does this laboratory routinely use Chromagar for the identification or differentiation of Candida isolates?

Yes

No

Unknown



(changed question number, updated question wording)

9) Species-level identification is performed for Candida spp. isolated from which of the following?

  1. Blood isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Other normally sterile body site isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Abdominal isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Respiratory isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Urine isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Other (specify) ________

Yes, reflexively

Yes, with clinician order

No

Unknown


  1. Species-level identification is performed for Candida spp. isolated from which of the following?

  1. Blood isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Other normally sterile body site isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Abdominal isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Respiratory isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Urine isolates

Yes, reflexively

Yes, with clinician order

No

Unknown

  1. Other (specify) ________

Yes, reflexively

Yes, with clinician order

No

Unknown



(changed question number)

10) Does your laboratory employ the T2Candida Panel to identify Candida from blood specimens?

Yes (go to 10a)

No (go to 11)

Unknown

    1. If Yes, when did this lab first start using T2Candida Panel? Date (mm/dd/yyyy): ____/____/________

    2. If Yes, does this lab culture blood if you get a positive result on T2Candida Panel?

Yes, reflexively

Yes, with a clinical order

No

Unknown

  1. Does this laboratory employ the T2Candida Panel to identify Candida from blood specimens?

Yes (go to 12a)

No (go to 13)

Unknown

    1. If Yes, when did this lab first start using T2Candida Panel? Date (mm/dd/yyyy): ____/____/________

    2. If Yes, does this lab culture blood if you get a positive result on T2Candida Panel?

Yes, reflexively

Yes, with a clinical order

No

Unknown

(changed question number, updated question wording, updated question numbers for proper skip logic in response options)

11) Does your laboratory employ the BioFire (FilmArray) to identify Candida from blood culture?

Yes (go to 11a)

No (go to 12)

Unknown

    1. If Yes, when did this lab first start using BioFire? Date (mm/dd/yyyy): ____/____/________

    2. If yes, does this lab reflexively culture blood if you get a positive result on BiorFire?

Yes, reflexively

Yes, with a clinical order

No

Unknown

  1. Does this laboratory employ the BioFire (FilmArray) to identify Candida from blood culture?

Yes (go to 13a)

No (go to 14)

Unknown

    1. If Yes, when did this lab first start using BioFire? Date (mm/dd/yyyy): ____/____/________





(Deleted 11b)



(changed question number, updated question wording, updated question numbers for proper skip logic in response options, removed sub-question 11b)

12) If No for both Question 10 and 11, does this laboratory have plans to employ culture-independent diagnostics for Candida identification in the near future (e.g. T2Candida Panel, BioFire)?

Yes

No

Unknown

Not applicable (Yes to Q17 or Q18)

  1. If No for both Question 12 and 13, does this laboratory have plans to employ culture-independent diagnostics for Candida identification in the near future (e.g. T2Candida Panel, BioFire)?

Yes

No

Unknown

Not applicable



(changed question number, updated question wording, updated response wording for ‘not applicable’)

13) Does your laboratory offer any antifungal susceptibility testing for Candida?

Yes (Continue onto Page 2)

No (-- If No, QUESTIONNAIRE COMPLETE---)

Unknown (is there another laboratory staff

member who can assist with the

questionnaire?)


  1. Does this laboratory offer any antifungal susceptibility testing for Candida either onsite or sent to another laboratory?

Yes

No (-- If No, QUESTIONNAIRE COMPLETE---)

Unknown (is there another laboratory staff

member who can assist with the

questionnaire?)



(changed question number, updated question wording, updated response wording for ‘yes’)

14) Where is antifungal susceptibility testing (AFST) done? (check all that apply)

On-site, in the laboratory

Sent to commercial lab

Sent to affiliated hospital lab

Other ______________________________

Unknown

  1. Where is antifungal susceptibility testing (AFST) done? (check the most applicable)

On-site, in the laboratory

Sent to commercial lab

Sent to affiliated hospital lab

Sent to other local/regional, non-affiliated reference or public health laboratory (new collection)

Other ______________________________

Unknown



(changed question number, updated question wording, added additional response option)

New Instructions

Answer the following questions for the lab selected in question 16.

15) Is antifungal susceptibility testing available for any of the following antifungal drugs (check all that apply):

Fluconazole

Voriconazole

Itraconazole

Posaconazole

Micafungin

Anidulafungin

Caspofungin

Amphotericin B

Flucytosine

Other (specify) __________________

Unknown

  1. Is antifungal susceptibility testing available for any of the following antifungal drugs (check all that apply):

Fluconazole

Voriconazole

Itraconazole

Posaconazole

Micafungin

Anidulafungin

Caspofungin

Amphotericin B

Flucytosine

Other (specify) __________________

Unknown



(changed question number)

16) What methods are used for AFST? (check all that apply)

Non-commercial broth microdilution

YeastOne

E test

Vitek

Other _________________

Unknown

  1. If you use Vitek for AFST, what Candida species do you test with it? (check all that apply)

C. albicans C. parapsilosis

C. glabrata

Other Candida spp.

  1. What methods are used for AFST? (check all that apply)

Non-commercial broth microdilution

YeastOne

E test

Vitek

Other _________________

Unknown

  1. If you use Vitek for AFST, what Candida species do you test with it? (check all that apply)

C. albicans C. parapsilosis

C. glabrata

Other Candida spp.



(changed question number)

17) How are results of AFST reported? (select one)

Categorical interpretation only (susceptible, resistant, etc.)

MIC only

Both--categorical interpretation PLUS MIC

Unknown

  1. If categorical interpretation only, how do you determine the categorical interpretation? (check all that apply)

CLSI M27 S4

CLSI M27 S3

From manufacturer of MIC test

Apply epidemiologic breakpoints

Other ____________________

  1. How are results of AFST reported? (select one)

Categorical interpretation only (susceptible, resistant, etc.)

MIC only

Both--categorical interpretation PLUS MIC

Unknown

  1. If categorical interpretation only, how do you determine the categorical interpretation? (check all that apply)

CLSI M27 S4

CLSI M27 S3

From manufacturer of MIC test

Apply epidemiologic breakpoints

Other ____________________



(changed question number)

18) For what type of Candida isolates is antifungal susceptibility testing (AFST) performed automatically/reflexively? (check all that apply)

Blood isolates

Other normally sterile body site isolates

Other (specify) ______________________

No AFST performed automatically (requires

order from a clinician)

Unknown

  1. For what type of Candida isolates is antifungal susceptibility testing (AFST) performed automatically/reflexively? (check all that apply)

Blood isolates

Other normally sterile body site isolates

Other (specify) ______________________

No AFST performed automatically (requires

order from a clinician)

Unknown



(changed question number)

19) How is AFST performed for the following Candida spp.?

    1. C. albicans

Performed automatically/reflexively

(Go to 19ai)

Performed with a clinician’s order

Not performed

  1. Drugs for which AFST is performed automatically/reflexively on C. abicans (check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

    1. C. glabrata

Performed automatically/reflexively

(Go to 19bi)

Performed with a clinician’s order

Not performed

  1. Drugs for which AFST is performed automatically/reflexively on C. glabrata (check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

    1. C. parapsilosis

Performed automatically/reflexively

(Go to 19ci)

Performed with a clinician’s order

Not performed

  1. Drugs for which AFST is performed automatically/reflexively on C. parapsilosis (check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

    1. Other Candida spp.

Performed automatically/reflexively

(Go to 19di)

Performed with a clinician’s order

Not performed

  1. Drugs for which AFST is performed automatically/reflexively on other Candida spp.(check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

  1. How is AFST performed for the following Candida spp.?

    1. C. albicans

Performed automatically/reflexively

(Go to 21ai)

Performed with a clinician’s order

(Go to 21ai)

Not performed

  1. Drugs for which AFST is performed on C. abicans (check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

    1. C. glabrata

Performed automatically/reflexively

(Go to 21bi)

Performed with a clinician’s order

(Go to 21bi)

Not performed

  1. Drugs for which AFST is performed on C. glabrata (check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

    1. C. parapsilosis

Performed automatically/reflexively

(Go to 21ci)

Performed with a clinician’s order

(Go to 21ci)

Not performed

  1. Drugs for which AFST is performed on C. parapsilosis (check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown

    1. Other Candida spp.

Performed automatically/reflexively

(Go to 21di)

Performed with a clinician’s order

(Go to 21di)

Not performed

  1. Drugs for which AFST is performed on other Candida spp.(check all that apply):

Micafungin

Anidulafungin

Caspofungin

Fluconazole

Voriconazole

Amphotericin B

Other

Unknown



(changed question number, changed skip logic question numbers in response options, updated question wording)



  1. Invasive Staphylococcus aureus (iSA) Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT)

2020 Survey Question

Proposed Changes Survey Question

1. Do you set up culture for sterile sites (blood, CSF, bone, etc.) for Staphylococcus aureus on site (in-house at your laboratory?

Yes - GO TO Q2 No


1. Do you routinely set up culture for sterile sites (blood, CSF, bone, etc.) on site (in-house at your laboratory?

Yes - GO TO Q2 No – GO TO Q3

(updated question wording and skip pattern)

1a. [if no} To which laboratory do you send sterile specimens for Staphylococcus aureus culture?

1a. [if no] To which laboratory do you send sterile specimens for culture/identification?

(updated question wording)


2. Is S. aureus or MRSA routinely identified via culture-based methods on site (in-house) at your laboratory? Yes - GO TO Q3 No

(added question)


2a. [if no] To which laboratory do you send cultures for S. aureus identification? ___________________

(added question)

2. Do you run any culture independent diagnostic tests (CIDT) for detection of S. aureus or MRSA either directly from a sterile source (CSF, Blood, etc.) or from a positive blood culture?

Yes No - GO TO Q2d


3. Do you routinely run any culture independent diagnostic tests (CIDT) on site or at another lab for detection of S. aureus or MRSA either directly from a sterile source (CSF, Blood, etc.) or from a positive blood culture?

Yes No - GO TO Q3d

(updated question number, wording, and skip pattern)

2a. [If yes] Do you run the CIDT on site or send out to another lab?

On-site Send out, please specify lab __________________

3a. [If yes] Where is CIDT testing completed?

On-site Send out, please specify lab __________________ - GO TO Q3c

(updated question number, wording, and skip pattern)

2b. Which CIDTs do you use (sterile site sources only, i.e. blood, CSF, pleural fluid, bone, etc.)? Please check all that apply.

FilmArray® Blood Culture Identification Panel..Date started__________

Verigene® Gram-Positive Blood Culture Test…Date started__________

Verigene® Staphylococcus Blood Culture Test…Date started__________

Cepheid Xpert® MRSA/SA BC…Date started__________

BD Geneohm® StaphSR…Date started__________

AdvanDx Staphylococcus QuickFISH blood culture kit…Date started__________

AdvanDx S. aureus/CNS PNA FISH…Date started__________

Alere BinaxNOW® Staphylococcus aureus test…Date started__________

Great Basin Staph ID/R blood culture panel…Date started__________

T2Bacteria® Panel…Date started__________

Accelerate PhenoTest™ BC kit…Date started ________________

iCubate iC-GPC Assay™…Date started ________________

mecA XpressFISH® …Date started ________________

Micacom hemoFISH Masterpanel … Date started ________________

ePlex BCID-GP Panel … Date started ________________

Other, Lab Developed Test (detects MRSA or SA)… Date started ____________________

Other commercial test, Specify_______...Date started__________

3b. Which CIDTs do you use (sterile site sources only, i.e. blood, CSF, pleural fluid, bone, etc.)? Please check all that apply.

FilmArray® Blood Culture Identification Panel..Date started__________

Verigene® Gram-Positive Blood Culture Test…Date started__________

Verigene® Staphylococcus Blood Culture Test…Date started__________

Cepheid Xpert® MRSA/SA BC…Date started__________

BD Geneohm® StaphSR…Date started__________

AdvanDx Staphylococcus QuickFISH blood culture kit…Date started__________

AdvanDx S. aureus/CNS PNA FISH…Date started__________

Alere BinaxNOW® Staphylococcus aureus test…Date started__________

Great Basin Staph ID/R blood culture panel…Date started__________

T2Bacteria® Panel…Date started__________

Accelerate PhenoTest™ BC kit…Date started ________________

iCubate iC-GPC Assay™…Date started ________________

mecA XpressFISH® …Date started ________________

Micacom hemoFISH Masterpanel … Date started ________________

ePlex BCID-GP Panel … Date started ________________

Other, Lab Developed Test (detects MRSA or SA)… Date started ____________________

Other commercial test, Specify_______...Date started__________

(updated question number)

2c. [If using any of the above tests on sterile site specimens] Do you still obtain an isolate for S. aureus or MRSA? Yes No - GO to Q3

3c. [If using any of the above tests on sterile site specimens] Do you still obtain an isolate for S. aureus or MRSA? Yes No - GO to Q4

(updated question number and skip pattern)

2d. [If no] Do you plan to start offering any CIDTs for S. aureus or MRSA within the next year?

Yes No – END SURVEY

3d. [If no] Do you plan to start offering any CIDTs for S. aureus or MRSA within the next year?

Yes No – END SURVEY

(updated question number)

2e. When do you plan to start offering culture independent diagnostic tests?

Month/Year: ____/____

3e. When do you plan to start offering CIDTs?

Month/Year: ____/____

(updated question number and wording)


3f. Where do you plan to have CIDT tested?

On-site Send out, please specify lab __________________ - END SURVEY

(added question)

3. How does your lab use the CIDT for detection of S. aureus or MRSA? (select one)

Test concurrently with culture

Reflex to culture after positive by CIDT panel

Only run CIDT panel, no additional testing is done

Other, specify _____________

4. How does your lab use the CIDT for detection of S. aureus or MRSA? (select one)

Test concurrently with culture

Reflex to culture after positive by CIDT panel

Only run CIDT panel, no additional testing is done

Other, specify _____________

(updated question number)


Comments

(added comments field)



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorNti-Berko, Sonja Mali (CDC/DDID/NCEZID/DPEI)
File Modified0000-00-00
File Created2021-01-13

© 2024 OMB.report | Privacy Policy