Sepsis Electronic Protocol Submission Tool

1. Sepsis Electronic Protocol Submission Tool IPRO and the NYS Department of Health July 23, 2013 & August 7, 2013

2. Agenda: • Introduction • Presenters, recording, & technical support • NYSDOH Introduction & Regulation Review • Regulation & guidance document location, intent & expectations • IPRO Process Overview • Submission requirements, clinical overview of protocol requirements • IPRO Website Presentation • Access, stages of completion, submission of protocol, outcome • Questions and Answers • Regulatory, clinical, technical

3. Presenters & recording: Presenters: NYSDOH: Foster Geston, M.D. IPRO: Wendy Ferguson, R.N., Dip.Ed. Kathy Terry, Ph.D. Recording: Available at the link for this webinar (within 3 days of this session)

4. NYSDOH Regulation and Guidance Sepsis regulation: • Overview • Effective May 1, 2013 • www.health.ny.gov search ‘Sepsis Regulation’ Sepsis guidance document • Provided as an attachment to June 2013 NYSDOH ‘Dear Colleague’ letter

5. Protocol Submission: Protocols must be submitted for review: • By September 3, 2013 Protocols may be submitted earlier: • Submission website open: July 24, 2013 • Complete contact form to receive logon ID at http://www.surveymonkey.com/s/JLBZ7X6 • Details in IPRO Medicaid Admin Memo July 9, 2013 • Implementation date: December 31, 2013

6. Sepsis Protocol Preparation The Guidance Document contains the following elements to include in your Sepsis Protocol • Early identification • Treatment • Exclusions • Training • Attestations • Each section is divided into Yes/No questions to be answered during the protocol submission process.

7. Sepsis Protocol Preparation Early Identification: • How is severe sepsis and septic shock identified for both adult and pediatric patients? • Include alerts i.e., computer alerts, lab systems, code announcements, charts and flow diagrams, phone systems, contact attending physicians etc. • Specify ER identification and inpatient identification of sepsis. • Be specific with clinical and lab findings or refer to published guidelines used by your hospital.

8. Sepsis Protocol Preparation Treatment: • Physiologic conditions and/or clinical conditions to consider • the insertion of a central venous catheter with or without central venous pressure and central venous oxygen saturation monitoring • the use of vasopressors • Treatment targets with explicit methods of measurement with timeframe goals. • Criteria for transfer to more intensive level of care than is able to be provided at the initial facility. State in protocol if your hospital is the highest level of care.

9. Sepsis Protocol Preparation Treatment cont.. • Include adult physiologic measurements that guide resuscitation. • Pediatric protocols should specify early IV/IO access and fluid resuscitation (ACCM guidelines). • Include: • Fluid resuscitation amounts • Physiologic goals to be reached within 60 minutes of initial resuscitation • Administration and use of cardiovascular drugs for fluid refractory septic shock

10. Sepsis Protocol Preparation Treatment cont.. • Specify whether the hospital uses an ‘invasive or ‘non-invasive’ • protocol • defined by early insertion of a central venous catheter for all adult severe sepsis and septic shock patients with associated monitoring of central venous pressure and central venous oxygen saturation • if using both approaches, describe the circumstances or settings in which one or the other is being used. • Include explicit criteria for defining when a pediatric protocol will be • applied versus an adult protocol.

11. Sepsis Protocol Preparation Exclusions: • Include in protocol if your hospital is excluding any of the following: • Patients for whom interventions in the protocol are clinically contraindicated. • Patients with advanced directives in place at the time of care which preclude any protocol interventions. • Patients or surrogate decision maker declined or is unwilling to consent to protocol interventions. • Enrollees in IRB approved clinical trials for which interventions are inconsistent with established protocols. • Newborns and infants in the NICU. • No others patients should be excluded from the protocol.

12. Sepsis Protocol Preparation Training: To demonstrate readiness to implement, continued application of the sepsis regulations, and reporting, include a description of: • staff who will be trained • the mode and frequency of training • Information Technology resources that will be engaged to facilitate protocol implementation. • Information Technology resources that will be engaged to facilitate data reporting to the DOH

13. Sepsis Protocol Preparation Attestations: IPRO’s Medicaid Administrative Memorandum dated July 9, 2013 contained a template for CEO and CMO attestations. The attestation page can be prepared on letterhead, signed and uploaded along with the protocol.

14. Process Overview-Documents: Protocols: • Adult • Pediatric • Unified or combined • Training • Attestations

15. Process Overview-Documents: Document requirements: • Ten (10) pagelimit for each protocol • Adobe PDF file Format: • Narrative • Flowchart, diagram, process map

16. Website Demonstration: • Access • Stages of completion • Submission of protocol for review • Outcome of review

17. Questions? • For more information: • Please review the recorded webinar • May send questions not addressed in the webinar to sepsis@ipro.us.