Crosswalk of Changes

Cross walk - 2022 form changes

ABCs

1. ABCs Case Report Form - Attachment #3

2021 form (Current)	2022 form (Proposed)
24c. □ Mark if this is a HiNSES fetal death with placenta and/or amniotic fluid isolate, a stillbirth, or neonate <22 wks gestation.	Removed

FoodNet

1. FoodNet Active Surveillance Data Elements List – Attachment #4

Refer to Attachment #4 - Changes are highlighted in Yellow

2. FoodNet Hemolytic Uremic Syndrome Data Elements List – Attachment #5

Refer to Attachment #5 - Changes are highlighted in Yellow

3. Diagnostic Laboratory Practices and Volume Elements List – Attachment #6

Refer to Attachment #6 – Changes are highlighted in Yellow

FluSurv-Net

1. FluSurv-NET Influenza Surveillance Project Case Report Form– Attachment #7

Question on 2020-21 Form	Question on 2021-22 Form
(N/A)	G1. Reason for admission Influenza related illness OB/Labor and delivery admission Inpatient surgery procedures Psychiatric admission needing acute medical care Trauma Other, specify: _________________ Unknown
G2. Acute signs/symptoms present at admission (began or worsened within 2 weeks prior to admission) Non-respiratory symptoms: Altered mental status/confusion Fever/chills Seizures Respiratory symptoms: Congested/runny nose Cough Shortness of breath/respiratory distress Sore throat URI/ILI Wheezing	G2. Acute signs/symptoms present at admission (began or worsened within 2 weeks prior to admission) Non-respiratory symptoms: Abdominal pain Altered mental status/confusion Anosmia/decreased smell Chest pain Conjunctivitis Diarrhea Dysgeusia/decreased taste Fatigue Fever/chills Headache Muscle aches/myalgias Nausea/vomiting Rash Seizures Respiratory symptoms: Congested/runny nose Cough Hemoptysis/bloody sputum Shortness of breath/respiratory distress Sore throat URI/ILI Wheezing For cases <2 years: Apnea Cyanosis Decreased vocalization/stridor Dehydration Hypothermia Inability to eat/poor feeding Lethargy
N/A	G8. Alcohol abuse Current Former No/Unknown
N/A	G9. Substance abuse Current Former No/Unknown
N/A	G10. Substance Abuse Type (Current use only) check all that apply IVDU Polysubstance abuse – not otherwise specified Opioids Cocaine Methamphetamines Marijuana (ingested or unknown route) Unknown Other, specify
N/A	G10. Code status on admission: Full code DNR/DNI/CMO Unknown
H1b. Chronic Lung Disease Active Tuberculosis (TB) Asbestosis Bronchiectasis Bronchiolitis obliterans Chronic bronchitis Chronic respiratory failure Cystic fibrosis (CF) Emphysema/Chronic obstructive pulmonary disease (COPD) Interstitial lung disease (ILD) Obstructive sleep apnea (OSA) Oxygen (O2) dependent Pulmonary fibrosis Restrictive lung disease Sarcoidosis Other, specify	H1b. Chronic Lung Disease Active Tuberculosis (TB) Asbestosis Bronchiectasis Bronchiolitis obliterans Chronic bronchitis Chronic respiratory failure Cystic fibrosis (CF) Emphysema/Chronic obstructive pulmonary disease (COPD) Interstitial lung disease (ILD) Obstructive sleep apnea (OSA) Oxygen (O2) dependent Pulmonary fibrosis Restrictive lung disease Sarcoidosis
H1c. Chronic Metabolic Disease Adrenal Disorders (Addison’s disease, adrenal insufficiency, Cushing syndrome, congenital adrenal hyperplasia) Diabetes mellitus (DM) Glycogen or other storage diseases (See list) Hyper/Hypo- function of pituitary gland Inborn errors of metabolism (See list) Metabolic syndrome Parathyroid dysfunction (hyperparathyroidism, hypoparathyroidism) Thyroid dysfunction (Grave’s disease, Hashimoto’s disease, hyperthyroidism, hypothyroidism) Other, specify	H1c. Chronic Metabolic Disease Adrenal Disorders (Addison’s disease, adrenal insufficiency, Cushing syndrome, congenital adrenal hyperplasia) Diabetes mellitus (DM) Glycogen or other storage diseases (See list) Hyper/Hypo- function of pituitary gland Inborn errors of metabolism (See list) Metabolic syndrome Parathyroid dysfunction (hyperparathyroidism, hypoparathyroidism) Thyroid dysfunction (Grave’s disease, Hashimoto’s disease, hyperthyroidism, hypothyroidism) Other, specify
H1d. Blood disorders/Hemoglobinopathy Alpha thalassemia Aplastic anemia Beta thalassemia Coagulopathy (Factor V Leiden, Von Willebrand disease (VWD), see list) Hemoglobin S-beta thalassemia Leukopenia Myelodysplastic syndrome (MDS) Neutropenia Pancytopenia Polycythemia vera Sickle cell disease Splenectomy/Asplenia Thrombocytopenia Other, specify	H1d. Blood disorders/Hemoglobinopathy Alpha thalassemia Aplastic anemia Beta thalassemia Coagulopathy (Factor V Leiden, Von Willebrand disease (VWD), see list) Hemoglobin S-beta thalassemia Leukopenia Myelodysplastic syndrome (MDS) Neutropenia Pancytopenia Polycythemia vera Sickle cell disease Splenectomy/Asplenia Thrombocytopenia
H1e. Cardiovascular Disease Aortic aneurysm (AAA), history of Aortic/Mitral/Tricuspid/Pulmonic valve replacement, history of Aortic regurgitation (AR) Aortic stenosis (AS) Atherosclerotic cardiovascular disease (ASCVD) Atrial fibrillation (AFib) Atrioventricular (AV) blocks Automated implantable devices (AID/AICD)/Pacemaker Bundle branch block (BBB/RBBB/LBBB) Cardiomyopathy Carotid stenosis Cerebral vascular accident (CVA)/Incident/Stroke, history of Congenital heart disease (Specify) Atrial septal defect Pulmonic stenosis Tetralogy of Fallot Ventricular septal defect Other, specify: Coronary artery bypass grafting (CABG), history of Coronary artery disease (CAD) Deep vein thrombosis (DVT), history of Heart failure/Congestive heart failure (CHF) Myocardial infarction (MI), history of Mitral regurgitation (MR) Mitral stenosis (MS) Peripheral artery disease (PAD) Peripheral vascular disease (PVD) Pulmonary embolism (PE), history of Pulmonary hypertension (PHTN) Pulmonic regurgitation Pulmonic stenosis Transient ischemic attack (TIA), history of Tricuspid regurgitation (TR) Tricuspid stenosis Ventricular fibrillation (VF, VFib), history of Ventricular tachycardia (VT, VTach), history of Other, specify	H1e. Cardiovascular Disease Aortic aneurysm (AAA), history of Aortic/Mitral/Tricuspid/Pulmonic valve replacement, history of Aortic regurgitation (AR) Aortic stenosis (AS) Atherosclerotic cardiovascular disease (ASCVD) Atrial fibrillation (AFib) Atrioventricular (AV) blocks Automated implantable devices (AID/AICD)/Pacemaker Bundle branch block (BBB/RBBB/LBBB) Cardiomyopathy Carotid stenosis Cerebral vascular accident (CVA)/Incident/Stroke, history of Congenital heart disease (Specify) Atrial septal defect Pulmonic stenosis Tetralogy of Fallot Ventricular septal defect Other, specify: Coronary artery bypass grafting (CABG), history of Coronary artery disease (CAD) Deep vein thrombosis (DVT), history of Heart failure/Congestive heart failure (CHF) Myocardial infarction (MI), history of Mitral regurgitation (MR) Mitral stenosis (MS) Peripheral artery disease (PAD) Peripheral vascular disease (PVD) Pulmonary embolism (PE), history of Pulmonary hypertension (PHTN) Pulmonic regurgitation Pulmonic stenosis Transient ischemic attack (TIA), history of Tricuspid regurgitation (TR) Tricuspid stenosis Ventricular fibrillation (VF, VFib), history of Ventricular tachycardia (VT, VTach), history of
H1f. 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, specify	H1f. 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
H1h. Immunocompromised Condition AIDS or CD4 count<200 Complement deficiency (See list) Graft vs. host disease (GVHD) HIV infection Immunoglobulin deficiency/immunodeficiency (See list) Immunosuppressive therapy (within the 12 months previous to admission) (see instructions): If yes, for what condition? Leukemia* Lymphoma/Hodgkins/Non-Hodgkins (NHL)* Metastatic cancer* Multiple myeloma* Solid organ malignancy* If yes, which organ? Steroid therapy (within 2 weeks of admission) (see instructions) Transplant, hematopoietic stem cell (bone marrow transplant (BMT), peripheral stem cell transplant (PSCT)), history of Transplant, solid organ (SOT), history of Other, specify	H1h. Immunocompromised Condition AIDS or CD4 count<200 Complement deficiency (See list) Graft vs. host disease (GVHD) HIV infection Immunoglobulin deficiency/immunodeficiency (See list) Immunosuppressive therapy (within the 12 months previous to admission) (see instructions): If yes, for what condition? Leukemia* Lymphoma/Hodgkins/Non-Hodgkins (NHL)* Metastatic cancer* Multiple myeloma* Solid organ malignancy* If yes, which organ? Steroid therapy (within 2 weeks of admission) (see instructions) Transplant, hematopoietic stem cell (bone marrow transplant (BMT), peripheral stem cell transplant (PSCT)), history of Transplant, solid organ (SOT), history of
H1i. Any Obesity? Obese Morbidly obese (ADULTS ONLY)	H1i. Any Obesity? Obese Severely/Morbidly obese (ADULTS ONLY)
H1l. Renal Disease Chronic kidney disease (CKD)/chronic renal insufficiency (CRI) Dialysis (HD) End stage renal disease (ESRD) Glomerulonephritis (GN) Nephrotic syndrome Polycystic kidney disease (PCKD) Other, specify	H1l. Renal Disease Chronic kidney disease (CKD)/chronic renal insufficiency (CRI) Dialysis (HD) End stage renal disease (ESRD) Glomerulonephritis (GN) Nephrotic syndrome Polycystic kidney disease (PCKD)
H1m. Gastrointestinal/Liver Disease (Do Not Record GERD) Alcoholic hepatitis Autoimmune hepatitis Barrett’s esophagitis Chronic liver disease Chronic pancreatitis Cirrhosis/End stage liver disease (ESLD) Crohn’s disease Esophageal varices Esophageal strictures Hepatitis B, chronic (HBV) Hepatitis C, chronic (HCV) Non-alcoholic fatty liver disease (NAFLD)/NASH Ulcerative colitis (UC) Other, specify	H1m. Gastrointestinal/Liver Disease (Do Not Record GERD) Alcoholic hepatitis Autoimmune hepatitis Barrett’s esophagitis Chronic liver disease Chronic pancreatitis Cirrhosis/End stage liver disease (ESLD) Crohn’s disease Esophageal varices Esophageal strictures Hepatitis B, chronic (HBV) Hepatitis C, chronic (HCV) Non-alcoholic fatty liver disease (NAFLD)/NASH Ulcerative colitis (UC)
H1n. Rheumatologic/Autoimmune/Inflammatory Conditions (Do Not Record OA) Ankylosing spondylitis Dermatomyositis Juvenile idiopathic arthritis Kawasaki disease Microscopic polyangiitis Polyarteritis nodosum (PAN) Polymyalgia rheumatica Polymyositis Psoriatic arthritis Rheumatoid arthritis (RA) Systemic lupus erythematosus (SLE)/Lupus Systemic sclerosis Takayasu arteritis Temporal/Giant cell arteritis Vasculitis, other (See list) Other, specify	H1n. Rheumatologic/Autoimmune/Inflammatory Conditions (Do Not Record OA) Ankylosing spondylitis Dermatomyositis Juvenile idiopathic arthritis Kawasaki disease Microscopic polyangiitis Polyarteritis nodosum (PAN) Polymyalgia rheumatica Polymyositis Psoriatic arthritis Rheumatoid arthritis (RA) Systemic lupus erythematosus (SLE)/Lupus Systemic sclerosis Takayasu arteritis Temporal/Giant cell arteritis Vasculitis, other (See list)
N/A	I1. Were any culture tests performed within 7 days of admission (For patients that died in the hospital, include culture tests performed either 1) within 7 days of admission, 2) within 3 days prior to death, or 3) within 24 hours after death) Yes No Unknown
N/A	I2. If yes was there a positive culture for aspergillus, mucormycosis, or a bacterial pthogen? Yes No Unknown
N/A	I2a. If yes, specify Pathogen 1
N/A	I2b. Date of culture
N/A	I2c. Site where pathogen identified Blood Bronchoalveolar lavage (BAL) Pleural fluid Cerebrospinal fluid (CSF) Sputum Endotracheal aspirate Other, specify
N/A	I2d. If Staphylococcus aureus, specify Methicillin resistant (MRSA) Methicillin sensitive (MMSA) Sensitivity unknown
N/A	J1b. Adenovirus Yes, positive Yes, negative, Not tested/Unknown
N/A	J1c. Parainfluenza 1 Yes, positive Yes, negative, Not tested/Unknown Date
N/A	J1d. Parainfluenza 2 Yes, positive Yes, negative, Not tested/Unknown Date
N/A	H1e. Parainfluenza 3 Yes, positive Yes, negative, Not tested/Unknown Date
N/A	H1f. Parainfluenza 4 Yes, positive Yes, negative, Not tested/Unknown Date
N/A	H1g. Human metapneumovirus Yes, positive Yes, negative, Not tested/Unknown Date
N/A	H1h. Rhinovirus/Entervirus Yes, positive Yes, negative, Not tested/Unknown Date
N/A	H1j. Coronavirus type Yes, positive Yes, negative, Not tested/Unknown Date
N/A	L1. Was a chest x-ray taken within 3 days of hospitalization? Yes No Unknown
N/A	L2. Were any of these chest x-rays abnormal? Yes No Unknown
N/A	L2a. Date of first abnormal chest x-ray
N/A	L2b. 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
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 prematurity/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)	M1. 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 prematurity/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) or adults (MIS-A) Other thrombosis/embolism/coagulopathy Pneumonia Pulmonary embolism (PE) Reyes syndrome Rhabdomyolysis Sepsis Seizures Stroke (CVA) Toxic shock syndrome (TSS)
N/A	O1. Total # of pregnancies as of date of admission (Gravida, G)
N/A	O2. Total # of pregnancies that resulted ina live birth as of date of admission (Parity, P)
N/A	O3. Specify total # of fetuses for current pregnancy as of date of admission 1 2 3 >3 Unknown
N/A	O4. Specify gestational age in weeks as of date of admission
N/A	O4a. 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
N/A	O5. Indicate pregnancy status at discharge or death Still pregnant No longer pregnant Unknown
N/A	O5a. If patient was pregnant on admission but no longer pregnant at discharge, indicate pregnancy outcome at discharge Healthy newborn Ill newborn Infant died Miscarriage (intrauterine death at <20 weeks GA) Still birth (intrauterine death at ≥20 weeks GA) Abortion Unknown
N/A	O5b. Pre-term live birth (<37 weeks GA) Yes No Unknown Pre-term delivery, gestational age in weeks

2. FluSurv-NET/RSV Laboratory Survey– Attachment #8

Question on 2020-21 form	Question on 2021-22 form
4a. Select the kit name(s) (manufacturer) for the rapid influenza antigen diagnostic test(s) performed at the laboratory (Check all that apply): BD Veritor™ System for Rapid Detection of Flu A+B (CLIA-waived), (Becton Dickinson & Co.) BD Veritor™ System for Rapid Detection of Flu A+B (Moderately Complex), (Becton Dickinson & Co.) Binax NOW® Influenza A&B Card 2 (Abbott) BioSign® Flu A+B or OraSure QuickFlu Rapid A+B Test or Polymedco Poly stat Flu A&B Test or LifeSign LLC Status Flu A&B (Princeton BioMedtech Corp.) QuickVue® Influenza A+B Test (Quidel Corp.) Sofia® Analyzer and Influenza A+B FIA (CLIA-waived) (Quidel Corp.) Sofia® Analyzer and Influenza A+B FIA (Quidel Corp.) XPECT™ Influenza A/B (Remel Inc./Thermo Fisher Scientific) Other, specify	4a. Select the kit name(s) (manufacturer) for the rapid influenza antigen diagnostic test(s) performed at the laboratory (Check all that apply): Acucy Influenza A&B Test (Sekisui Diagnostics, LLC) BD Veritor™ System for Rapid Detection of Flu A+B (CLIA-waived), (Becton Dickinson & Co.) BD Veritor™ System for Rapid Detection of Flu A+B (Moderately Complex), (Becton Dickinson & Co.) Binax NOW® Influenza A&B Card 2 (Abbott) BioSign® Flu A+B or OraSure QuickFlu Rapid A+B Test or Polymedco Poly stat Flu A&B Test or LifeSign LLC Status Flu A&B (Princeton BioMedtech Corp.) OSOM Ultra Plus Flu A&B Test (Sekisui Diagnostics, LLC) QuickVue® Influenza A+B Test (Quidel Corp.) Sofia® Analyzer and Influenza A+B FIA (CLIA-waived) (Quidel Corp.) Sofia® Analyzer and Influenza A+B FIA (Quidel Corp.) XPECT™ Influenza A/B (Remel Inc./Thermo Fisher Scientific) Other, specify:
4b. If more than one kit is selected above, please select the one kit that is (or will be) used most frequently for rapid influenza diagnostic testing at the laboratory during the current influenza season: BD Veritor™ System for Rapid Detection of Flu A+B (CLIA-waived), (Becton Dickinson & Co.) BD Veritor™ System for Rapid Detection of Flu A+B (Moderately Complex), (Becton Dickinson & Co.) Binax NOW® Influenza A&B Card 2 (Abbott) BioSign® Flu A+B or OraSure QuickFlu Rapid A+B Test or Polymedco Poly stat Flu A&B Test or LifeSign LLC Status Flu A&B (Princeton BioMedtech Corp.) QuickVue® Influenza A+B Test (Quidel Corp.) Sofia® Analyzer and Influenza A+B FIA (CLIA-waived) (Quidel Corp.) Sofia® Analyzer and Influenza A+B FIA (Quidel Corp.) XPECT™ Influenza A/B (Remel Inc./Thermo Fisher Scientific) Other, specify	(Deleted question)
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	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) BioCode Respiratory Pathogen Panel, (Applied BioCode Inc)* BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)*‡ BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)*‡ CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A Subtyping Kit), (CDC Influenza Division) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit), (CDC Influenza Division) CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (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) Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV, (Cepheid)‡ Cobas Liat Influenza A/B, (Roche Diagnostics)† Cobas Liat Influenza A/B & RSV, (Roche Diagnostics)† Cobas SARS-CoV-2 & Influenza A/B (Roche Diagnostics)‡ Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test, (Roche Diagnostics) ePlex Respiratory Pathogen Panel (GenMark Diagnostics)*†‡ ePlex Respiratory Pathogen Panel 2, (Genmark Diagnostics)*‡ eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)* FilmArray® Pneumonia Panel plus, (BioFire Diagnostics) FilmArray® Respiratory Panel, (BioFire Diagnostics, LLC)* FilmArray® Respiratory Panel 2 (BioFire Diagnostics, LLC)* FilmArray® Respiratory Panel, EZ (BioFire Diagnostics, LLC)* FluChip-8G Influenza A+B Assay, (InDevR)* 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)*‡ Quest Diagnostics RC COVID-19 +Flu RT-PCR, (Quest Diagnostics)‡ Silaris Infuenza A & Btg, (Sekisui Diagnostic)† Sofia 2 Flu + SARS Antigen FIA, (Quidel) †‡ 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) Simplexa™ Flu A/B & RSV Gen II (Diasorin)* 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	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) BioCode Respiratory Pathogen Panel, (Applied BioCode Inc)* BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)*‡ BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)*‡ CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A Subtyping Kit), (CDC Influenza Division) CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (Influenza A/B Typing Kit), (CDC Influenza Division) CDC Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set, (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) Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV, (Cepheid)‡ Cobas Liat Influenza A/B, (Roche Diagnostics)† Cobas Liat Influenza A/B & RSV, (Roche Diagnostics)† Cobas SARS-CoV-2 & Influenza A/B (Roche Diagnostics)‡ Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test, (Roche Diagnostics) ePlex Respiratory Pathogen Panel (GenMark Diagnostics)*†‡ ePlex Respiratory Pathogen Panel 2, (Genmark Diagnostics)*‡ eSensor® Respiratory Viral Panel (RVP), (GenMark Diagnostics)* FilmArray® Pneumonia Panel plus, (BioFire Diagnostics) FilmArray® Respiratory Panel, (BioFire Diagnostics, LLC)* FilmArray® Respiratory Panel 2 (BioFire Diagnostics, LLC)* FilmArray® Respiratory Panel, EZ (BioFire Diagnostics, LLC)* FluChip-8G Influenza A+B Assay, (InDevR)* 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)*‡ Quest Diagnostics RC COVID-19 +Flu RT-PCR, (Quest Diagnostics)‡ Silaris Infuenza A & Btg, (Sekisui Diagnostic)† Sofia 2 Flu + SARS Antigen FIA, (Quidel) †‡ 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) Simplexa™ Flu A/B & RSV Gen II (Diasorin)* 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? 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	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
5d. What testing kit does the testing facility use (or will it 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	(Deleted question)
6. Does the laboratory perform any of the any of the following additional tests to detect influenza (other than RT-PCR or RIDT)? Viral culture Indirect fluorescent antibody (IFA) stain Direct fluorescent antibody (DFA) stain Serology (IgG or IgM) No	(Deleted question)
7a. Which influenza test method does the laboratory perform most frequently for pediatric patients (aged 0-17 years)? Viral culture Indirect fluorescent antibody (IFA)/direct fluorescent antibody stain (DFA) Rapid influenza antigen diagnostic test (rapid test, RIDT) Rapid Molecular assay (e.g. RT-PCR, NAAT) – singleplex or dualplex† Standard Molecular assay (e.g. RT-PCR, NAAT) – singleplex (influenza only) Standard Molecular assay (e.g. RT-PCR, NAAT) – multiplex/respiratory viral panel (RVP) Not applicable (no pediatric testing)	6a. Which influenza test method does the laboratory perform most frequently for pediatric patients (aged 0-17 years)? Rapid influenza antigen diagnostic test (rapid test, RIDT) Rapid Molecular assay (e.g. RT-PCR, NAAT) – singleplex or dualplex† Standard Molecular assay (e.g. RT-PCR, NAAT) – singleplex (influenza only) Standard Molecular assay (e.g. RT-PCR, NAAT) – multiplex/respiratory viral panel (RVP) Not applicable (no pediatric testing)
7b. Which influenza test method does the laboratory perform most frequently for adult patients (aged ≥18 years)? Viral culture Indirect fluorescent antibody (IFA)/direct fluorescent antibody stain (DFA) Rapid influenza antigen diagnostic test (rapid test, RIDT) Rapid Molecular assay (e.g. RT-PCR, NAAT) – singleplex or dualplex† Standard Molecular assay (e.g. RT-PCR, NAAT) – singleplex (influenza only) Standard Molecular assay (e.g. RT-PCR, NAAT) – multiplex/respiratory viral panel (RVP) Not applicable (no pediatric testing)	6b. Which influenza test method does the laboratory perform most frequently for adult patients (aged ≥18 years)? Rapid influenza antigen diagnostic test (rapid test, RIDT) Rapid Molecular assay (e.g. RT-PCR, NAAT) – singleplex or dualplex† Standard Molecular assay (e.g. RT-PCR, NAAT) – singleplex (influenza only) Standard Molecular assay (e.g. RT-PCR, NAAT) – multiplex/respiratory viral panel (RVP) Not applicable (no pediatric testing)
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	7. 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? __% Other test type __% Rapid influenza diagnostic test (rapid test, RIDT) __% Rapid Molecular Assay __% Standard Molecular Assay – singleplex or dualplex __% Standard Molecular Assay – multiplex /respiratory viral panel

HAIC

1. HAIC: Invasive Methicillin-resistant Staphylococcus aureus (MRSA) Infection Case Report Form (Attachment #9)

2021 CRF Question

Changes to the 2022 CRF Question

Note: this is not a new data collection, we are simply adding to CRF to clarify the existing data collection

Address Type:___________

34a. Did the patient have a positive test for SARS-CoV-2 (molecular assay, serology, or other confirmatory test) on or before the DISC?

□ Yes □ No □ Unknown

34a. Did the patient have a positive test(s) for SARS-CoV-2 (molecular assay, serology, or other confirmatory test) in the year before or day of the DISC?

□ Yes □ No □ Unknown

34a.

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 □ Method unknown □ Other (specify): ________
MOST RECENT positive test for SARS-CoV-2 on or before the DISC	__-__-____ □ Unknown	□ Molecular assay □ Serology □ Method unknown □ Other (specify): ________

34a.

IF YES, complete below for MOST RECENT positive test for SARS-CoV-2 in the year before or day of the DISC:

Specimen collection date:

__-__-____ □ Unknown

Test type:

□ Antigen

□ Molecular assay

□ Serology

□ Method unknown

□ Other (specify): ________

2. HAIC: Invasive Methicillin-sensitive Staphylococcus aureus (MSSA) Infection Case Report Form (Attachment #10)

2021 CRF Question

Changes to the 2022 CRF Question

Note: this is not a new data collection, we are simply adding to CRF to clarify the existing data collection

Address Type:___________

34a. Did the patient have a positive test for SARS-CoV-2 (molecular assay, serology, or other confirmatory test) on or before the DISC?

□ Yes □ No □ Unknown

34a. Did the patient have a positive test(s) for SARS-CoV-2 (molecular assay, serology, or other confirmatory test) in the year before or day of the DISC?

□ Yes □ No □ Unknown

34a.

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 □ Method unknown □ Other (specify): ________
MOST RECENT positive test for SARS-CoV-2 on or before the DISC	__-__-____ □ Unknown	□ Molecular assay □ Serology □ Method unknown □ Other (specify): ________

34a.

IF YES, complete below for MOST RECENT positive test for SARS-CoV-2 in the year before or day of the DISC:

Specimen collection date:

__-__-____ □ Unknown

Test type:

□ Antigen

□ Molecular assay

□ Serology

□ Method unknown

□ Other (specify): ________

3. HAIC: CDI Case Report and Treatment Form (Attachment #11)

2021 CRF	2022 CRF	Changes
Address (number, Street, Apt. No., City, State, Zip)	Address	Made address free text
[Field not on CRF]	Address type	New field
4. Date of incident C. diff+ stool collection	4. Date of incident C. diff+ stool collection (DISC)	Added “(DISC)”
15. Was the patient hospitalized on the day of or in the 6 calendar days after the date of incident C. diff+ stool collection?	15. Was the patient hospitalized on the day of or in the 6 calendar days after the DISC?	Changed “date of incident C. diff+ stool collection” to “DISC”
16. Where was the patient located on the 3rd calendar day before the date of incident C. diff+ stool collection?	16. Where was the patient located on the 3rd calendar day before the DISC?	Changed “date of incident C. diff+ stool collection” to “DISC”
20. Exposures to healthcare in the 12 weeks before the date of incident C. diff+ stool collection	20. Exposures to healthcare in the 12 weeks before the DISC	Changed “date of incident C. diff+ stool collection” to “DISC”
20a.1 If yes, date of discharge closest to date of incident C. diff+ stool collection	20a.1 If yes, date of discharge closest to DISC	Changed “date of incident C. diff+ stool collection” to “DISC”
26. Was the patient in an ICU on the day of or in the 6 days after the date of incident C. diff+ stool collection?	26. Was the patient in an ICU on the day of or in the 6 days after the DISC?	Changed “date of incident C. diff+ stool collection” to “DISC”
27. Symptoms (in the 6 calendar days before, the day of, or 1 calendar day after the date of incident C. diff+ stool collection)	27. Symptoms (in the 6 calendar days before, the day of, or 1 calendar day after the DISC)	Changed “date of incident C. diff+ stool collection” to “DISC”
[Field not on CRF]	28. Fever (in the 2 calendar days before or calendar day of the DISC)	New field
	¨  Fever ≥38°C or ≥100.4°F documented
	o   Highest fever documented: _______________ °C or ________________ °F
	¨  Self-reported fever
	¨  No fever documented
	¨  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)	29. Toxic megacolon and ileus (in the 6 calendar days before, the day of, or the 6 calendar days after the DISC)	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”
29. Was pseudomembranous colitis listed in the surgical pathology, endoscopy, or autopsy report in the 6 calendar days before, the day of, or the 6 calendar days after the date of incident C. diff+ stool collection?	30. Was pseudomembranous colitis listed in the surgical pathology, endoscopy, or autopsy report in the 6 calendar days before, the day of, or the 6 calendar days after the DISC?	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”
30. Colectomy (related to CDI)	31. Colectomy (related to CDI)	Changed question number
31. Were other enteric pathogens isolated from stool collected on the date of incident C. diff+ stool collection?	32. Were other enteric pathogens isolated from stool collected on the DISC?	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”; added “Astrovirus”, “Enteroaggregative E. coli (EAEC)”, “Enteropathogenic E. coli (EPEC)”, “Enterotoxigenic E. coli (ETEC)”, “Sapovirus”, and “Yersinia enterocolitica” as response options
·         Campylobacter	·         Astrovirus
·         Norovirus	·         Campylobacter
·         Rotavirus	·         Enteroaggregative E. coli (EAEC)
·         Salmonella	·         Enteropathogenic E. coli (EPEC)
·         Shiga toxin-producing E. coli	·         Enterotoxigenic E. coli (ETEC)
·         Shigella	·         Norovirus
·         Other (specify): ___________________	·         Rotavirus
·         None	·         Salmonella
·         No other pathogens tested	·         Sapovirus
·         Unknown	·         Shiga toxin-producing E. coli
	·         Shigella
	·         Yersinia enterocolitica
	·         Other (specify): ___________________
	·         None
	·         No other pathogens tested
	·         Unknown
32. LABORATORY FINDINGS (in the 6 calendar days before, the day of, or the 6 calendar days after the date of incident C. diff+ stool collection)	33. LABORATORY FINDINGS (in the 6 calendar days before, the day of, or the 6 calendar days after the DISC)	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”
32a. Albumin ≤ 2.5 g/dl	33a. Albumin ≤ 2.5 g/dl	Changed question number
32b. White blood cell count ≤ 1,000/µl	33b. White blood cell count ≤ 1,000/µl	Changed question number
32c. White blood cell count ≥ 15,000/µl	33c. White blood cell count ≥ 15,000/µl	Changed question number
[Field not on CRF]	33d. Serum creatinine > 1.5 mg/dl	New field
	¨  Yes
	¨  No
	¨  Not Done
	¨  Information not available
33. MEDICATIONS TAKEN in the 12 weeks before the date of incident C. diff+ stool collection	34. MEDICATIONS TAKEN in the 12 weeks before the DISC	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”
33a. Proton pump inhibitor (e.g. Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole)	34a. Proton pump inhibitor (e.g. Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole)	Changed question number
33b. H2 Blockers (e.g. Famotidine, Ranitidine, Cimetidine)	34b. H2 Blockers (e.g. Famotidine, Ranitidine, Cimetidine)	Changed question number
33c. Immunosuppressive therapy	34c. Immunosuppressive therapy	Changed question number
33d. Antimicrobial therapy	34d. Antimicrobial therapy	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”; added “Yes, name unknown”, “Cefadroxil”, "Cefiderocol", "Eravacycline", "Omadacycline", and “Vancomycin (PO for prophylaxis)” as response options
·         None	·         Yes, name unknown
·         Unknown	·         None
·         Amikacin	·         Unknown
·         Amoxicillin	·         Amikacin
·         Amoxicillin/clavulanic acid	·         Amoxicillin
·         Ampicillin	·         Amoxicillin/clavulanic acid
·         Ampicillin/sulbactam	·         Ampicillin
·         Azithromycin	·         Ampicillin/sulbactam
·         Aztreonam	·         Azithromycin
·         Cefazolin	·         Aztreonam
·         Cefdinir	·         Cefadroxil
·         Cefepime	·         Cefazolin
·         Cefixime	·         Cefdinir
·         Cefotaxime	·         Cefepime
·         Cefoxitin	·         Cefiderocol
·         Cefpodoxime	·         Cefixime
·         Ceftaroline	·         Cefotaxime
·         Ceftazidime	·         Cefoxitin
·         Ceftazidim/avibactam	·         Cefpodoxime
·         Ceftizoxime	·         Ceftaroline
·         Ceftolozane/tazobactam	·         Ceftazidime
·         Ceftriaxone	·         Ceftazidim/avibactam
·         Cefuroxime	·         Ceftizoxime
·         Cephalexin	·         Ceftolozane/tazobactam
·         Ciprofloxacin	·         Ceftriaxone
·         Clarithromycin	·         Cefuroxime
·         Clindamycin	·         Cephalexin
·         Dalbavancin	·         Ciprofloxacin
·         Daptomycin	·         Clarithromycin
·         Delafloxacin	·         Clindamycin
·         Doripenem	·         Dalbavancin
·         Doxycycline	·         Daptomycin
·         Ertapenem	·         Delafloxacin
·         Fosfomycin	·         Doripenem
·         Gentamicin	·         Doxycycline
·         Imipenem/cilastatin	·        Eravacyclin
·         Levofloxacin	·         Ertapenem
·         Linezolid	·         Fosfomycin
·         Meropenem	·         Gentamicin
·         Meropenem/vaborbactam	·         Imipenem/cilastatin
·         Metronidazole	·         Levofloxacin
·         Moxifloxacin	·         Linezolid
·         Nitrofurantoin	·         Meropenem
·         Oritavancin	·         Meropenem/vaborbactam
·         Penicillin	·         Metronidazole
·         Piperacillin/tazobactam	·         Moxifloxacin
·         Polymixin B	·         Nitrofurantoin
·         Polymixin E (colistin)	·         Omadacycline
·         Rifaximin	·         Oritavancin
·         Tedizolid	·         Penicillin
·         Telavancin	·         Piperacillin/tazobactam
·         Tigecycline	·         Polymixin B
·         Tobramycin	·         Polymixin E (colistin)
·         Trimethoprim	·         Rifaximin
·         Trimethoprim/sulfamethoxazole	·         Tedizolid
·         Vancomycin (IV)	·         Telavancin
·         Other (specify): ____________________	·         Tigecycline
	·         Tobramycin
	·         Trimethoprim
	·         Trimethoprim/sulfamethoxazole
	·         Vancomycin (IV)
	·         Vancomycin (PO for prophylaxis)
	·         Other (specify): ____________________
33e. Was patient treated for suspected or confirmed CDI in the 12 weeks before the date of incident specimen collection?	34e. Was patient treated for suspected or confirmed CDI in the 12 weeks before the DISC?	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”
34. Treatment for incident CDI	35. Treatment for incident CDI	Changed question number
35. Previous unique CDI episode (>8 weeks before the date of incident C. diff+ stool collection)	36. Previous unique CDI episode (>8 weeks before the DISC)	Changed question number; changed “date of incident C. diff+ stool collection” to “DISC”
36. Any recurrent C. diff episodes following this incident C. diff episode?	37. Any recurrent C. diff episodes following this incident C. diff episode?	Changed question number
37. CRF Status	38. CRF Status	Changed question number
38. Initials of S.O.	39. Initials of S.O.	Changed question number
39. Date of abstraction	40. Date of abstraction	Changed question number
40. Did the patient have a POSITIVE test(s) for SARSCoV- 2 (molecular assay, serology or other confirmatory test) on or before the DISC?	41. Did the patient have a POSITIVE test(s) for SARS-CoV-2 (molecular assay, serology, or other confirmatory test) in the year before or day of the DISC?	Changed question number, changed "on or before the DISC" to "in the year before or day of the DISC"
40a. If YES, complete table below	41a. If YES, complete below for MOST RECENT positive test for SARS-CoV-2 in the year before or date of the DISC:	Changed question number, changed wording to limit the scope of the question
FIRST positive test for SARS-CoV-2 on or before the DISC - specimen collection date	[Field not on CRF]	Removed field
FIRST positive test for SARS-CoV-2 on or before the DISC - test type	[Field not on CRF]	Removed field
MOST RECENT positive test for SARS-CoV-2 on or before the DISC - specimen collection date	41a.1. Specimen collection date	Added question number, reworded question
MOST RECENT positive test for SARS-CoV-2 on or before the DISC - test type	41a.2: Test type	Added question number, reworded question
41a. COVID-NET Case ID	42a. COVID-NET Case ID	Changed question number
41b. NNDSS IDs	42b. NNDSS IDs	Changed question number

4. HAIC: CDI Annual Surveillance Officers Survey (Attachment #12)

Existing question	Modified question
2. In 2020, did any laboratories drop out of participation?	2. In 2021, did any laboratories drop out of participation? (changed year to 2021 to reflect change in survey year)
3. In 2020, did you identify any additional laboratories inside or outside of your catchment area which identify C.diff assays from persons who are residents of your catchment area?	3. In 2021, did you identify any additional laboratories inside or outside of your catchment area which identify C.diff assays from persons who are residents of your catchment area? (changed year to 2021 to reflect change in survey year)
10. Did your site complete a physician/outpatient provider survey in 2020?	10. Did your site complete a physician/outpatient provider survey in 2021? (changed year to 2021 to reflect change in survey year)
13. For each facility that treated a case in 2020, please provide the following	13. For each facility that treated a case in 2021, please provide the following (changed year to 2021 to reflect change in survey year)

5. HAIC: Annual Survey of Laboratory Testing Practices for C. difficile Infections (Attachment #13)

Current	Proposed
Was this a new laboratory in 2020?	Was this a new laboratory in 2021?
Did this lab participate in surveillance in 2020?	Did this lab participate in surveillance in 2021?
How often did you receive line lists from this lab in 2020?	How often did you receive line lists from this lab in 2021?
How did you receive line lists from this lab in 2020?	How did you receive line lists from this lab in 2021?
Did you receive specimens from this lab in 2020?	Did you receive specimens from this lab in 2021?
Types of facilities in your catchment area served by this lab in 2020 (select all that apply):	Types of facilities in your catchment area served by this lab in 2021 (select all that apply):
Did your laboratory ever send specimens off-site for Clostridioides difficile testing in 2020?	Did your laboratory ever send specimens off-site for Clostridioides difficile testing in 2021?
2. What type and order of testing was routinely used by your laboratory in standard testing for C. difficile on December 31, 2020?	2. What type and order of testing was routinely used by your laboratory in standard testing for C. difficile on December 31, 2021?
2c. Did your laboratory perform any onsite testing for C. difficile outside of your normal testing algorithm in 2020?	2c. Did your laboratory perform any onsite testing for C. difficile outside of your normal testing algorithm in 2021?
3a. Which EIA test kit was used by your laboratory in 2020?	3a. Which EIA test kit was used by your laboratory in 2021?
3b. Which Nucleic Acid Amplification test was used by your laboratory in 2020?	3b. Which Nucleic Acid Amplification test was used by your laboratory in 2021?
4a. If your laboratory used a multiplexed molecular diagnostic (e.g., Biofire Filmarray GI Panel, Luminex xTAG GPP) to test for several GI pathogens in 2020, did your laboratory suppress the C. difficile result so that clinicians could not see it?	4a. If your laboratory used a multiplexed molecular diagnostic (e.g., Biofire Filmarray GI Panel, Luminex xTAG GPP) to test for several GI pathogens in 2021, did your laboratory suppress the C. difficile result so that clinicians could not see it?
4b. If your laboratory used a multiplexed diagnostic in 2020 and the result was suppressed, where does the suppression occur?	4b. If your laboratory used a multiplexed diagnostic in 2021 and the result was suppressed, where does the suppression occur?
5a. If your laboratory used a nucleic acid amplification test (NAAT) (e.g., Cepheid Xpert C. difficile) as first line testing followed by a toxin EIA test (whenever NAAT result is positive) in 2020, did your laboratory suppress the positive NAAT result so that clinicians could not see it?	5a. If your laboratory used a nucleic acid amplification test (NAAT) (e.g., Cepheid Xpert C. difficile) as first line testing followed by a toxin EIA test (whenever NAAT result is positive) in 2021, did your laboratory suppress the positive NAAT result so that clinicians could not see it?
5b. If your laboratory used NAAT as first line testing followed by confirmatory toxin EIA testing in 2020, and both the NAAT and toxin EIA results were released to the clinician, did your laboratory provide any comments to help the clinician interpret the test results (e.g., NAAT-positive only result might represent colonization, etc.)?	5b. If your laboratory used NAAT as first line testing followed by confirmatory toxin EIA testing in 2021, and both the NAAT and toxin EIA results were released to the clinician, did your laboratory provide any comments to help the clinician interpret the test results (e.g., NAAT-positive only result might represent colonization, etc.)?
6. What are the LOINC or internal testing codes associated with the tests your lab used in 2020 (e.g. LOINC codes 13957-6, 34713-8, or 54067-4)?	6. What are the LOINC or internal testing codes associated with the tests your lab used in 2021 (e.g. LOINC codes 13957-6, 34713-8, or 54067-4)?
7a. In 2020, did your laboratory experience any shortages in supplies, reagents, and/or test kits for performing C. difficile testing (e.g., NAAT or EIA reagents, swabs)?	7a. In 2021, did your laboratory experience any shortages in supplies, reagents, and/or test kits for performing C. difficile testing (e.g., NAAT or EIA reagents, swabs)?
7b. If your laboratory experienced a supply shortage for C. difficile testing in 2020, how did the shortage affect your laboratory’s ability to perform C. difficile testing? (Check all that apply)	7b. If your laboratory experienced a supply shortage for C. difficile testing in 2021, how did the shortage affect your laboratory’s ability to perform C. difficile testing? (Check all that apply)
7c. In 2020, did your laboratory experience a high demand for COVID-19 testing that limited the availability of staff (e.g., reduced staffing or work time) or the use of equipment to perform C. difficile testing?	7c. In 2021, did your laboratory experience a high demand for COVID-19 testing that limited the availability of staff (e.g., reduced staffing or work time) or the use of equipment to perform C. difficile testing?
8. Did your lab testing algorithm for C. difficile change between January 1, 2020 and December 31, 2020?	8. Did your lab testing algorithm for C. difficile change between January 1, 2021 and December 31, 2021?
8a. (If yes) What was the previous type and order of testing performed by your lab in 2020 before it changed its testing algorithm?	8a. (If yes) What was the previous type and order of testing performed by your lab in 2021 before it changed its testing algorithm?
9. Did your lab have a policy to reject stool specimens for C. difficile testing in 2020?	9. Did your lab have a policy to reject stool specimens for C. difficile testing in 2021?
9a. Did your rejection policy for stool specimens change between January 1, 2020 and December 31, 2020?	9a. Did your rejection policy for stool specimens change between January 1, 2021 and December 31, 2021?
10. How many stool samples did you test for C. difficile each month in 2020?	10. How many stool samples did you test for C. difficile each month in 2021?

6. HAIC: Candidemia Case Report (Attachment #14)

2021 CRF Question	2022 CRF Question
CANDIDEMIA 2021 CASE REPORT FORM (header) (changed year)	CANDIDEMIA 2022 CASE REPORT FORM (header) (changed year)
Version: Short Form 2021, Last Updated: 07/21/2020 (footnotes) (changed year and date)	Version: Short Form 2022, Last Updated: 07/21/2022 (footnotes) (changed year and date)
New Question	Address type: 1Residential 2 Post office 3 Long-term care facility 4 Corrections 5 Military 6 Homeless 7 Other 8 Insufficient 9 Missing
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	35. Did the patient receive invasive mechanical ventilation in the 30 days before the DISC, not including the DISC? 1 Yes 0 No 9 Unknown (changed question order/number)
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	36. 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 (changed question order/number)
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 1a. If yes, date of specimen collection for initial positive SARS-CoV-2 test: Date: ________ 9 Date Unknown 1b. If yes, EIP COVID-NET Case ID: ____________ 9 Unknown Out of EIP COVID-NET catchment area	56. Did the patient have a positive SARS-CoV-2 test result (molecular assay, serology, or other confirmatory test) from a specimen collected in the 90 days before the DISC or on the DISC? 1 Yes 0 No 9 Unknown 56a. If yes, date of specimen collection for initial positive SARS-CoV-2 test: Date: ________ 9 Date Unknown 56b. If yes, EIP COVID-NET Case ID: ____________ 9 Unknown 0 Out of EIP COVID-NET catchment area (changed question order/number)
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	58a. If yes, what was the reason steroids were administered? (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 (changed question order/number)
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 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	60. Did the patient receive any of the following immunomodulatory drugs in the 30 days before the DISC, not including the DISC? ­­­­­ None Tocilizumab Sarilumab Baricitinib Unknown 60a. If yes were any of the immunomodulatory drugs given as part of treatment/management for COVID-19? 1 Yes 0 No 9 Unknown (changed question order/number)
Question 35-55	Changed number by 2
Question 54-56	Changed number by 3
Question 57-59	Changed number by 4
Question 61-62	Changed number by 3

7. HAIC: Laboratory Testing Practices for Candidemia Questionnaire (Attachment #15)

2021 CRF Question	2022 CRF Question
2021 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE (header)	2022 LABORATORY TESTING PRACTICES FOR CANDIDEMIA QUESTIONNAIRE (header) (changed year)
New Question	How does this laboratory meet proficiency testing requirements for yeast identification? Commercial provider (specify) _________________ Internal alternate assessments (specify) __________________
New Question	Does this laboratory employ culture-independent diagnostic tests (CIDT) to identify Candida from blood specimens? Yes (got to q14) No (got to q17) Unknown
New Question	15b. If Yes, does this lab reflexively culture blood if you get a positive result on BioFire? Yes, reflexively Yes, with a clinical order No Unknown
New Question	Does this laboratory employ any other CIDTs to identify Candida from blood specimens? Yes (specify) ______________________ No Unknown
New Question	22) How does this laboratory meet proficiency testing requirements for antifungal susceptibility testing, if performed? Commercial provider (specify) _________________ Internal alternate assessments (specify) _________
13) Does this laboratory employ the BioFire (FilmArray) to identify Candida from blood culture? Yes (go to 13a) No (go to 14) Unknown	15) Does this laboratory employ the BioFire (FilmArray) to identify Candida from blood culture? Yes (go to 15a) No (go to 16) Unknown (Changed question number and updated question numbers in responses to allow for correct skip logic)
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	If No for Question 13, does this laboratory have plans to employ culture-independent diagnostics for Candida identification in the near future (e.g. T2Candida Panel, BioFire)? Yes (specify)________________ No Unknown Not applicable (changed question number, updated question wording, updated response wording to include ‘specify’)
Question 12	Question 14
Question 15-18	Changed question number by 3
Question 19-21	Changed question number by 4

8. HAIC: Invasive Staphylococcus aureus Laboratory Survey: Use of Nucleic Acid Amplification Testing (NAAT) (Attachment #16)

2020 Survey Question	Changes to the 2021 Survey Question
Data Edits section of CRF 2. Did your site have any challenges completing the CRF re-abstractions? _______ yes _______ no If yes, please describe_______________________	Data Edits section of CRF 2. Did your site complete CRF re-abstractions during 2021? _______ yes _______ no If yes, did you have any challenges completing the CRF re-abstractions? _______ yes _______ no i. If yes, please describe: ________________________________ b. If no, why not? __________________________________
Geocoding section of CRF 1. Is your site continuing to geocode SA cases? _______ yes _______ no	Did you site geocode SA cases in 2021? _______ yes _______ no If yes, what is the most recent year of surveillance data that was geocoded? ______ If no, why not? ________________________
	Vital Records Linkages 1. Did your site link SA cases to vital records (mortality matching) in 2021? _______ yes _______ no If yes, what is the most recent year of surveillance data that was linked? _______ If no, why not? ________________________
	COVID-19 Impact 1. Did COVID-19 response activities delay 2021 iSA surveillance work (e.g., unable to meet iSA deadlines during 2021)? _______ yes _______ no a. If no, how were you able to meet iSA deadlines? ________________________________ b. If yes, how did COVID-19 response activities delay your iSA work? __________________________