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Sepsis Reporting Webinar I

Sepsis Reporting Webinar I. IPRO and the NYS Department of Health In Collaboration with HANYS & GNYHA April 29, 2014. Agenda:. Introduction Presenters, recording, & technical support Presentation intent and future webinars NYSDOH Introduction & Overview

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Sepsis Reporting Webinar I

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  1. Sepsis Reporting Webinar I IPRO and the NYS Department of Health In Collaboration with HANYS & GNYHA April 29, 2014

  2. Agenda: Introduction • Presenters, recording, & technical support • Presentation intent and future webinars NYSDOH Introduction & Overview • Document location, data collection requirements & expectations Dictionary Overview • Variable categories, intent within categories, variable parameters Clinical Data Portal (CDP) High-level • Intent, basic structure, access/security requirements, stages of completion Questions and Answers

  3. Introduction: (1-2) Event Recording • http://protocol.sepsis.ipro.org Presentation Intent • Primary intent is the review of the data dictionary • Variable categories • Intent within categories • Variable parameters • High-level overview of data submission process • Retrospective data submission • Portal submission of data files (NOT a data collection tool)

  4. Protocol website:

  5. Introduction: (2-2) Presentation is NOT covering: • Measures • Data portal access in detail • Risk adjustment model(s) Future presentation(s) • Next presentation is scheduled for July and covers • Data submission portal access • Structuring and submitting data • Batch mode; troubleshooting upload issues; file receipt confirmation Frequently Asked Questions

  6. NYSDOH Overview: (1-2) Data Dictionary Location • NYSDOH HCS site & http://protocol.sepsis.ipro.org Data Requirements • Collect data on all severe sepsis and septic shock patients • Report all severe sepsis/septic shock cases with discharge dates >= 4/1/14 into the data portal • Include all patients admitted on or after 1/1/2014 who were discharged on or after 4/1/2014. Expectations and Timeline • The portal to receive data for the 1st Quarter (4/1/14-6/30/14 discharge dates) will be open from 8/1/14

  7. NYSDOH Overview: (2-2) IV. Reporting Transfers: • Both transferring and receiving hospitals are responsible for collecting and reporting sepsis data. • This includes reporting demographic, adherence, severity adjustment and co-morbidity variables. • Data from both institutions will be linked at a later stage for outcomes and adherence measures reporting.

  8. Data Dictionary Sections: Demographic variables • 21 variables (dictionary pages 3-24) • Ranges from demographics (name, DOB, etc) to protocol data (initiation, type, etc) Adherence variables • 29variables (dictionary pages 25-54) • Measures adherence to treatment protocols Severity adjustment variables • Four (4) variables (dictionary pages 55-59) • Will be used to create risk-adjusted mortality rates Co morbidity variables • 18variables (dictionary pages 60-78) • Will be used to create risk-adjusted mortality rates Index (pages79-81) Change log (page82)

  9. Demographics: (1-3) Includes basic demographic detail: • Unique Personal Identifier, Patient Control Number, DOB, Race, Insurance, Admission/Discharge, etc • Unique Personal Identifier (Same as SPARCS identifier) • "First 2" and "Last 2" characters of the Patient's Last Name. "First 2" characters of the Patient's First Name. "Last 4" digits of the Patient's Social Security Number. E.g., Mary Jones, SS 012345678 = JOESMA5678 • Race can have multiple entries • E.g., 01:04 (White: Asian)

  10. Demographics (2-3) Includes protocol initiation: • Was protocol initiated? • Where? • ER, floor, ICU • For whom? • Adults or Pediatrics Includes protocol exclusion: • Excluded? • Reason for exclusion • For Value 1 ‘Interventions Clinically Contraindicated’ requires specification • Exclusion date & time

  11. Demographics (3-3) Reason for exclusion: 1 = IV or IO fluids (acute, decompensated CHF) 2 = IV or IO fluids (ESRD w/signs of fluid overload) 3 = Antibiotics 4 = Central Line (significant uncorrectable coagulation abnormalities) 5 = Central Line (anatomic obstacles or limitations) 6 = Vasopressors or inotropes for refractory hypotension (significant uncorrectable coagulation abnormalities) 7 = Vasopressors or inotropes for refractory hypotension (anatomic obstacles or limitations) 8 = Mechanical Ventilation

  12. Adherence: Timing (1-2) • Earliest date/time • For patients whose protocol was initiated in the emergency room, this is the date/time of arrival to the emergency room. This is the first/earliest date/time recorded in the chart. This could be, but is not necessarily, the same as the triage date/time. • Triage date/time • For patients whose protocol was initiated in the emergency room, this is the date/time of the triage assessment of the patient. • Protocol date/time • If vascular access, fluids, vasopressors etc. initiated in ambulance the earliest date/time the protocol was started would be time of arrival to emergency room.

  13. Adherence: Timing (2-2) • Vascular access date/time • The earliest date/time vascular access (IV or IO) was obtained. • Date/time to leave ED and, designation • For patients whose sepsis protocol was initiated in the emergency department, this is the date/time they left the emergency department. • For patients whose sepsis protocol was initiated in the emergency department, this is where they went upon leaving the emergency department. • E.g., 1 = Non-ICU in same hospital 2 = ICU in same hospital

  14. Adherence: Lactate • Lactate – reported, date/time, level, re-ordered • Indicate whether a lactate level was reported by the lab. • Yes, No, Else indicated lactate was not ordered. • The date/time the first lactate level was reported by the lab. • The actual lactate level of the first test, and unit type. • Must be numeric to one decimal place (example 1.8). • Specify unit: mg/dL or mmol/L • Lactate re-ordered, date/time • Indicate whether a lactate level was re-ordered and date/time of re-order.

  15. Adherence: Blood Cultures • Blood cultures – obtained, result, pathogen • Indicate whether blood cultures were obtained. • The date/time the first blood culture was obtained. • Indicate if the result of the first blood culture was positive or negative. • Select the most abundant pathogen in the blood culture. • 0 = No pathogen reported 1 = Gram positive bacteria 2 = Gram negative bacteria • 3 = Anaerobic bacteria 4 = Yeast 5 = Fungus 6 = Mixed pathogens This culture could be up to 24 hours prior to the initiation of the sepsis protocol to 48 hours after the initiation of the sepsis protocol. A positive blood culture is defined as a recognized pathogen from one or more blood cultures or commensal from at least 2 cultures.

  16. Adherence: Antibiotics • Antibiotics – administered, date/time • Indicate whether broad spectrum antibiotics were administered. • 0 = Antibiotics not given. • 1 = Antibiotics given after the initiation of the sepsis protocol. • 2 = Antibiotics were given prior to the initiation of the sepsis protocol. . • The date/time broad spectrum antibiotics were started.

  17. Adherence: Fluids • Fluids – started, date/time, adults/pediatrics • Indicate whether fluids were started. • The date/time the first fluids were started. • Specify volume of fluid given for adult or pediatric patient. • Indicate the means of evaluating response to fluid resuscitation. • Submit a number for each applicable type of response, separated by a colon. Example “1:2:4” which represents options 1, 2, and 4. • 1 - IVC Ultrasound 2 - Central Venous Pressure 3 - Clinical Judgment 4 -ScVO2 or SVO2 5 -Lactate Clearance

  18. Adherence: Hypotension • Hypotension • Indicate if the patient has persistent hypotension that is not responsive to fluids. • 0 = Hypotension or elevated lactate level¹ not responsive to fluids • 1 = Hypotension or elevated lactate level responsive to fluids • 2 = No hypotension or elevated lactate ¹Elevated lactate is defined as >=4mmol/L.

  19. Adherence: Vasopressor • Vasopressor – Given, date/time • Indicate if the patient was given vasopressors/inotropes. • For pediatric patients, indicate if cardiovascular drug therapy support was given. • The date/time first vasopressors/inotropes/cardiovascular drug therapy support was given.

  20. Adherence: CVP, ScVO2 • CVP • Indicate whether CVP was measured. • The date/time CVP was measured. • ScVO2 • Indicate whether ScVO2 was measured. • The date/time ScVO2 was measured.

  21. Severity Adjustment Variables: (1-2) • Platelet Count • Was the platelet count at the time of sepsis protocol initiation <150,000 cells/mm3? • Bandemia • Was the band count more than 5% of the total white blood cell count at the time of the sepsis protocol initiation?

  22. Severity Adjustment Variables: (2-2) • Lower Respiratory Infection • Was there infiltrate on the patient’s chest radiograph or the presence of clinical findings suggestive of lower respiratory infection? • Altered Mental Status • Was there any difference from the patient’s baseline in any of the three spheres of orientation (sense of person/self, place and date/time) or in their level of alertness?

  23. Co morbidity Variables: (1-6) • Indicate if the patient has been diagnosed with severe sepsis/septic shock. • 0 = Patient was not diagnosed with either severe sepsis or septic shock. • 1 = Patient was diagnosed with severe sepsis. • 2 = Patient was diagnosed with septic shock. Record the highest level of severity of the patient. For example, if a patient had severe sepsis and progressed to septic shock, select 2 = Patient was diagnosed with septic shock. Pediatric patients should be categorized as having septic shock if unable to differentiate between severe sepsis and septic shock. • Was the severe sepsis/septic shock result of a hospital acquired infection? • Indicate the suspected or diagnosed site of infection.

  24. Co morbidity Variables: (2-6) • Indicate whether the patient had mechanical ventilation support during the hospital stay. • If yes, the date/time patient was first started on mechanical ventilation. • Indicate if the patient was admitted to the Intensive Care Unit (ICU). • If yes, the date/time patient was first admitted to the Intensive Care Unit (ICU). • If yes, the date the patient was first discharged from the Intensive Care Unit (ICU).

  25. Co morbidity Variables: (3-6) The data for these variables is demonstrated by a history of the condition reported in the chart by any source, lab or radiologic results which would be considered diagnostic of the condition or notation in the chart indicating the patient has been/was diagnosed with the condition before initiation of the protocol. • Patient has chronic respiratory failure that requires use of mechanical ventilation. • Indicate if patient has AIDS or HIV infection. • Indicate if patient has any solid, malignant neoplasm with evidence of metastasis beyond the primary involved organ, including involvement of lymph nodes (exclude lymphoma/leukemia/multiple myeloma).

  26. Co morbidity Variables: (4-6) The data for these variables is demonstrated by a history of the condition reported in the chart by any source, lab or radiologic results which would be considered diagnostic of the condition or notation in the chart indicating the patient has been/was diagnosed with the condition before initiation of the protocol. • Indicate if patient has malignant neoplasm of lymphatic and hematopoietic tissue including those neoplasms which may be in clinical remission. • Indicate if patient is taking disease modifying medications/therapies (drugs and biologics) for collagen diseases, corticosteroids, chemotherapeutic agents through any modality (oral, IV, IM, etc.) known to specifically adversely impact the function of the immune system as primary therapeutic goal or unintended side effect, including steroids (excluding inhaled or topical steroids), radiotherapy, chemotherapy.

  27. Co morbidity Variables: (5-6) The data for these variables is demonstrated by a history of the condition reported in the chart by any source, lab or radiologic results which would be considered diagnostic of the condition or notation in the chart indicating the patient has been/was diagnosed with the condition before initiation of the protocol. • An indication of congestive heart failure with evidence of treatment; include compensated and uncompensated congestive heart failure. • Indicate if patient has renal failure sufficient to require peritoneal dialysis or hemodialysis. • Indicate if patient has chronic liver disease as defined as the presence of cirrhosis or other liver disease accompanied by elevated bilirubin>2mg/dL and serum albumin <3.5g/dL, documentation of prior or present esophageal or gastric varices, portal hypertension, previous hepatic encephalopathy or ascites with notation of liver disease.

  28. Co morbidity Variables: (6-6) The data for these variables is demonstrated by a history of the condition reported in the chart by any source, lab or radiologic results which would be considered diagnostic of the condition or notation in the chart indicating the patient has been/was diagnosed with the condition before initiation of the protocol. • Indicate if patient was diagnosed and/or treated for diabetes or notation of a HbA1c of 6.5% or higher. Include patients on any pharmacologic therapy; exclude diet controlled, history of pregnancy related diabetes, and acute hyperglycemia without known history of diabetes. • Indicate if patient had an organ transplant including heart, lung, kidney, liver, pancreas, stem cell/bone marrow. Exclude corneal or skin transplant/grafting.

  29. Clinical Data Portal (CDP): • Intent and timeframe • Accepts patient-specific data for sepsis event reporting. • To be available August 2014. • Currently under development. • Data: single or batch upload • Cases may be uploaded as single case file or as a batch file. • All data must pass validation check for successful upload. • Errors/success will be displayed to hospital user prior to completion. • Error Report highlighted if case(s) fail validation. • File is discarded if any failures.

  30. Clinical Data Portal (CDP): • File formats • ASCII comma delimited .txt or .csv format • XML (e.g., HL7 CDA) (Phase 2) • Security • CDP process is similar to NHSN for HAI reporting. • Web-based portal directed through secure connection. • HTTPS website accessed via SSL/TLS • TLS 1.1 connection with 256 bit encryption • Certified GeoTrust Extended Validation Certificates • Data meets Federal HIPAA standards and is subject to FISMA & HITECH procedures • Hospital designated managers only to permit staff access

  31. Clinical Data Portal (CDP):

  32. Clinical Data Portal (CDP):

  33. Questions? • For more information: • Please review the recorded webinar • http://protocol.sepsis.ipro.org • Review Frequently Asked Questions • Send questions not addressed to sepsis@ipro.us.

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