NYP BEST PRACTICES Certificate of Need Process Angela Gonzalez-Perez Director, Regulatory Planning Angela Rios Director, Major Projects

Article 28 Fundamentals Public Health Law – Includes ALL of the components required to operate a hospital: Inpatient Units Outpatient Departments Support Services (Administrative, Financial) Infrastructure (Boilers, Generators, Fire Alarm and Fire Protection Systems) Hospital Clinical and Administrative (Article 28) vs. Private (non-Article 28) Cost Report, Square Footage, Reimbursement Article 28 regulations dictate the Certificate of Need (CON) process

What is a Certificate of Need (CON)? The Certificate of Need (CON) program is a review process, mandated under state law, which governs the establishment, ownership, construction and renovation of Article 28 health care facilities in New York State. Before new facilities are built, or existing facilities are renovated, Before facilities acquire major medical equipment, or add or delete services, When ownership of a facility is changed or transferred. Health care facilities must file an application and obtain approval before….

What Triggers a NYSDOH Regulatory Filing? What Triggers a Regulatory Filing? Medical Equipment Involving Ionizing Radiation Or Magnetic Resonance Surgical Or Other Invasive Procedure Areas Inpatient Units, Other Than Routine Maintenance And Repairs HVAC, Plumbing, Electrical, Water Supply, Fixed Dietary, Solid Waste and/or Sewage Disposal, And Fire Protection Systems, Other Than Routine Maintenance And Repairs

NYSDOH Regulatory Filings REVIEW TYPE DOH APPROVAL TIME COST THRESHOLD Construction Notice (Effective 1/20/2012) No Approval Timeframe None Limited Review Up to 8 Weeks < $6M Administrative Review 6-8 Months $6M through < under $50M Full Review > $50M 5

THE LIFE of a TYPICAL CON

RISKS OF NOT FILING Reimbursement Implications Citations Fines Program Suspension Or Closures Bad Press Heightened Scrutiny

RECENT CHANGES at NYSDOH NYSE CON System Electronic Submission of CONs Architectural Self Certification Letter (for projects under $15M) Signed and Sealed by Architect/Engineer Signed and Notarized by NYP Senior Vice President New Filing Type - Construction Notice DASNY for CON Drawing Reviews for projects not Self Certified

Projects that DO NOT Qualify NYSDOH Construction Notice No Approval Required, No Cost Threshold Projects that Qualify Projects that DO NOT Qualify Repair & Maintenance (including Cosmetic Renovations) Equipment Replacements Non-Clinical Infrastructure Correction of Cited Deficiencies Renovation/Reconfiguration of: Patient Rooms Operating Rooms Special Care Units Labs Treatment or Procedure Rooms Equipment Replacements with additional components Conversion of Double Bedded to Single Bedded Projects that do not conform to all applicable codes and regulations

PRE-CON SUBMISSION: A/E Requirements PROJECT ASSIGNMENT/FEASIBILITY STUDY Complete Code Review Analysis Pre-Design Meeting(s) with ORPPD, if applicable Walk-Through of Existing Space Review Scope Article 28 Requirements Life Safety Requirements

CON SUBMISSION: A/E Requirements Certification Letter(s) Self Certification for Projects Under $15M Certification for Projects Above $15M MRI Installation Existing Buildings CON Narrative Form Waiver Request Form, if applicable 2010 FGI Guidelines NFPA 101 Life Safety – Must be Reviewed and Approved by Regulatory Compliance Schematic Drawings – Must Submit In PDF Format Site Plan Existing Plan Proposed Plan - Must Include Support Spaces, Means of Egress, Adjacencies

POST CON SUBMISSION NYSDOH Requests For Additional Information Clarification on the Scope Clarification on the Drawings NYSDOH Contingency Responses Design Development Submission – NOW DASNY Interim Life Safety Measures (ILSM) Process Infection Control Risk Assessment Measures

DASNY PROCESS for CON PROJECTS 2 Full Sized Sets of drawings (including Architectural, Mechanical, Plumbing, Electrical, Fire Protection and Fire Alarm) Certificate of Need Application documentation as submitted to NYSDOH A functional program as required by 2010 FGI Standard Part 1.2-2 All Code Analyses completed for the project Any communication applicable to the application including Waivers

DURING CONSTRUCTION We Must Notify NYSDOH of Changes Phased Projects Scope Costs Major Medical Equipment Phased Projects A Pre-Occupancy Survey is Required for Each Phase Allot 1 Month Between Each Phase

PRE-OCCUPANCY SURVEY Date is requested with NYSDOH 3 Months Prior to Completion Pre-Occupancy Preparation A/E is Required for All Preparation Meetings NYSDOH DOCUMENTATION Building Type Certification A/E Certification(s) of Completion Essential Electrical Systems Certification Flame Spread for Materials and Finishes Life Safety Plan Fire Rated and Smoke Walls Means of Egress and Travel Distance(s) Fire Alarm Devices

PRE-OCCUPANCY SURVEY PREPARATION Email 8 weeks prior Regulatory Planning will send an email to the work group with the necessary information for the 1st preparation meeting Meeting 1 6 weeks prior Review any questions related to the preoccupancy list Review draft documentation Discuss issues Schedule follow-up meeting Meeting 2 2 weeks prior Review documentation Discuss do’s and don’ts Share details that relate to the day of the survey Walk- Through 1 week prior Conduct a walk through of the project scope and required support spaces and means of egress Meeting 3 3 days prior Review the finalized documentation binder (s) Review follow-up items that were identified during the walk through

PRE-OCCUPANCY SURVEY - ROLES Regulatory Planning Facilitator/Liaison to Agency Facilities Project Manager Compiles Certification Letter and Project Documentation Architect/Engineer Lead on Describing Scope and Project Details Project Administrator (s) Fire Safety Training Policies and Procedures, Staff Training & Credentials

Office of Strategy and Regulatory Planning NYP CON PROCESS MAP CON Kick-off Meeting Roles & Responsibilities Project Feasibility Approved Project Administrator Project Scope Patient Flow Staffing Funding Source Finance Business Plan Dept. Staffing Operating Budget Design & Construction Project Manager Architectural Narrative Schematics Certification Letters Capital Budget Bio-Med/IT Medical Equipment IT/Telecom CON Preparation Phase Regulatory Planning Review Docs Communicate Issues Compile CON Send for Internal Review Prepare Final CON Obtain Internal Sign-off CON Submission Submit to New York State Department of Health

NYP PROJECT PROCESS

OPPORTUNITIES for IMPROVEMENT Complete Thorough Code Analysis Review Existing Conditions Confirm Programmatic Requirements Documentation Provide Correct Certification Letters Provide Detailed Narratives Ensure CON Drawings are Consistent with Narrative

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