Regulatory Compliance Update

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Regulatory Compliance Update Time Critical Diagnosis: Hospitals Can Survive Sarah Willson, BSN, MBA Vice President of Clinical and Regulatory Affairs swillson@mhanet.com

Overview This webinar will provide participants with in-depth information regarding Time Critical Diagnosis laws updated in the 2016 and 2017 legislative sessions. In the sea of regulatory compliance, Missouri hospitals seek additional designations to hold themselves accountable to the public for providing the right care at the right time and in the right place. The TCD process in Missouri is heralded by hospitals for providing structure which enhances collaborative care of patients with a TCD. However, updating those processes through recent legislation has created some questions. Attendance at this webinar will ensure you have the right information to make needed changes to hospital policy and procedure.

Objectives Upon completion of this webinar, participants will be able to: describe essential changes to TCD law develop hospital policies and procedures to facilitate compliance with current state law describe new state regulatory changes for hospital providers

TCD Background

Missouri s TCD System Missouri s TCD System is a statewide system designed to bring together the 911 emergency phone system, ambulance services, and hospitals in a coordinated way to provide quicker and higher quality treatment Goal to increase the survival and recovery rate of people suffering a traumatic injury, stroke, or heart attack Built on Missouri s existing trauma system, which indentifies specific hospitals specially equipped for the treatment of serious injuries

Missouri s TCD System Missouri is the first state in the nation to enact legislation authorizing the creation of a statewide system of care for stroke and STEMI patients that is modeled after the trauma center system Several states have enacted similar systems Hospitals participating in the system must meet certain requirements to be designated as a trauma, stroke and/or STEMI center. Those requirements include having specialized medical teams and services available 24 hours a day, seven days a week. Each designation is granted separately based on a hospital s ability to meet the requirements for each type of emergency treatment.

Historical Legislative and Regulatory Timeline February 1999 December 2012 June 2013 August 2016 August 2017 Trauma regulations began under EMS DHSS to oversee TCD program Stroke/STEMI regulations in effect Legislative changes for stroke and registry reporting 732, 635 and 988 Legislative changes for Trauma and STEMI 50 and 501

Missouri s TCD System Information from the Department of Health and Services website 34 Trauma Centers Renews every 5 years Trauma transport protocol, Level IV designation, regulations update and pediatric trauma center designation questions to be addressed 54 Stroke Centers Renews every four years Approximately 50+ STEMI center applications Will renew every three years

2016 and 2017 Key Legislative Changes

2016 Key Legislative Changes Senate Bills 732, 635 and 988 Process by which facilities can be designated as stroke centers by a nationally recognized program Emergency Room Physician Education for trauma, stroke and STEMI Data collection changes for stroke and STEMI programs

2016 Legislative Update Emergency rule and proposed amendment printed in Missouri Register - September 15, 2017 Emergency rule filed August 7, effective August 17, expires February 22, 2018 Proposed amendment not yet adopted Includes JC, DNV-GL and HFAP Addresses designation, application and review only

2017 Key Legislative Changes Senate Bills 50 and 501 Process by which trauma and STEMI centers can be designated or verified by a nationally recognized program Repeals the provision requiring DHSS to generate quarterly reports EMS must provide data, DHSS must allow our hospitals the data they need, and hospitals must have a QI mechanism for the whole episode of care including pre-hospital.

2017 Key Legislative Changes If the hospital can prove that there is inconsistent application of regulatory standards across similar hospitals than such hospital does not have to comply with the specific inconsistent standard until such inconsistency is resolved DHSS to attend advisory committee meeting with hospitals

2017 Legislative Update Trauma and STEMI designation, application and review comments submitted Nothing filed in the Missouri Register to date

The Hospital Shall Annually, and within 30 days of any changes, submit to DHSS proof of trauma, stroke and STEMI certification and the names and contact information of the medical director and program manager of the stroke center Submit a copy of the certifying organization s final certification survey results within 30 days of receiving results Every five, four or three years (as applicable), submit an application, on a form prescribed by DHSS, for center review and designation Participate in the emergency medical services regional system of care as already defined in regulation by DHSS Participate in local and regional EMS systems by reviewing and sharing outcome data, and providing training and clinical education resources as already defined

The Hospital Shall Let DHSS know how they plan to submit data If using a national registry-will need to confer rights to data Can use form agreed upon with DHSS

Common Conversations What s the buzz?

Complaints DHSS believes complaints only related to center designation are to be referred to designating or verifying body Website updated to reflect this information

What s Up With AHA Registry GWTG-CAD and Mission: Lifeline Evolution MHA does not endorse one vendor over another. Information gathered to answer common questions being received from members.

GWTG-CAD GWTG-CAD was the AHA s premier AMI registry from 2001-2010. 1.The nearly 600 hospitals who used GWTG-CAD found great value in the real-time reports, comparative regional benchmarks and analytic features the Patient Management Tool Provided 2.In 2008 GWTG-CAD and ACTION Registry announced their intention to join together as the largest single registry for improving outcomes in AMI and ACS patients 3.By 2010, GWTG-CAD sites were transitioned to ACTION Registry-GWTG supported on NCDR platform Mission: Lifeline (M:L) In 2007, the AHA launched Mission: Lifeline to improve heart attack systems of care In 2011 AHA announced ACTION Registry-GWTG as the data source for Mission: Lifeline Reports Hospital recognition was offered in 2010 and EMS recognition in 2014 Looking Forward On April 7, 2017 the AHA announced the relaunch of GWTG-CAD GWTG-CAD is the primary data source for Mission: Lifeline participation Future iterations will offer additional data collection and reporting options

Mission: Lifeline Data and Reports Direct Entry Regardless data submission method, CAD was built to be the M:L Report Engine State Registry CAD = M:L Report Engine Vendor NCDR

Reports and Enhancements July 1, 2017 LIVE MLL Receiving MLL Referring MLL ACS Benchmarks for regional comparison reports Filters for analysis by patient groups Patient record drill down to flag outliers CSV upload for ease of data transfer Winter 2017-18 Full data and reports for Chest Pain Accreditation Additional elements for CAD and ACS tracking Optional fields for site specific tracking Transferring facility picker EMS Agency picker EMS Feedback Form

On The Horizon TCD Advisory Committee Market Changes New Diagnosis

TCD Unit Contact Peggy Huddleston, Administrative Assistant TCD Registry Administrator Phone: 573/526-1969 Peggy.Huddleston@health. mo.gov Nicole Gamm, BSN, R.N. Time Critical Diagnosis Unit Manager Phone: 573/751-6357 Fax: 573/522-9712 Nicole.Gamm@health.mo. gov Department of Health and Senior Services 920 Wildwood Drive P.O. Box 570 Jefferson City, MO 65109

QUESTIONS