Certificate of Need Process NYP Best Practices for Architects & Engineers May 2, 2016 Angela Gonzalez-Perez Director, Regulatory Planning

AGENDA  General Information -Article 28/CON Fundamentals -NYSDOH Recent Changes -Regulatory Filing Types  NYP Project Process  Pre-Occupancy Process 2

ARTICLE 28 FUNDAMENTALS  Governed by NY State Public Health Law  Includes ALL of the components required to operate a hospital:  Inpatient Units  Outpatient Departments  Support Services (Ancillary, Administrative, Financial)  Infrastructure (Boilers, Generators, Fire Alarm and Fire Protection Systems)  Hospital Space vs. University and Faculty Practice Space  Article 28 regulations dictate the Certificate of Need (CON) process 3

WHAT IS A CERTIFICATE OF NEED (CON)? The Certificate of Need (CON) program is a review process which governs the establishment, ownership, construction and renovation of Article 28 health care facilities in New York State. Through the CON program, NYS Department of Health: -Manages and allocates resources across the State -Ensures facilities comply with Programmatic, Architectural and Life Safety Codes 4

NYSDOH RECENT CHANGES Update to CON Applications  Executive Summary is now public  Additional requirements New Drawing Submission Guidelines & Option to Submit to DASNY  Schematic Drawings (DSG-01)  Design Development Drawings (DSG-02)  Final Construction Documents (DSG-05)  Waiver Submission (DSG-06) Update of Architectural/Engineering Certification Letters (5/2016)  Self-Certification Eligibility Checklist - Excludes More Projects New Pre-Occupancy Survey Process  New Documentation Checklist - Now electronically  Submission of documentation 2 weeks Prior to Survey 5

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REVIEW TYPE COST THRESHOLD ORP PREPARATION TIME DOH APPROVAL TIME APPLICATION FEE (Paid by ORP) PROCESSING FEE (Exclusive of DASNY Fee) Construction Notice None2 Weeks Prior to Start No Approval Timeframe $0 Limited Review < $6M3 Weeks~ 8 Weeks$1,000$0 Administrative Review $6M through < $50M* 4 Weeks ~ 6-8 Months $2,000.30% of Total Project Costs Full Review > $50M*4 Weeks~ 6-8 Months$2,000.55% of Total Project Costs NYSDOH REGULATORY FILING TYPES 7 * Varies by Facility

Construction Notice Criteria:  Non-Clinical Infrastructure Projects  Equipment Replacements (with or without construction)  Cosmetic Renovations  General repair or maintenance  Correction of Cited Deficiencies (CMS, FDNY and TJC) Requirements (must be received 2 weeks prior to start date):  CON Narrative Form  Construction Start and End Dates  Architect/Engineer Certification Letter  Physicst Certification Letter (for radiation producing equipment)  ILSM  ICRA NYSDOH REGULATORY FILING TYPES 8

Limited Review Application Criteria:  Renovation/Construction with Total Project costs up to $6M  Decertify services (regardless of cost)  Relocation of an extension clinic within the same service area (regardless of cost) Requirements:  CON Narrative Form  Architect/Engineering Certification Letter  Architectural Drawings per applicable DOH Drawing Submission Guidelines  Physicist Report and Certification Letter(for radiation producing equipment)  Draft Equipment Lease(s) NYSDOH REGULATORY FILING TYPES 9

Administrative Review Application Criteria:  Renovation/Construction Project with costs between $6M and $50M  Certification of a New Extension Clinic  Addition of a licensed service (regardless of cost) Requirements:  CON Narrative Form  Program and Need Narrative  Financial Schedules  Architect/Engineer Certification Letter  Architectural Drawings per applicable DOH Drawing Submission Guidelines  Physicist Report and Certification Letter(for radiation producing equipment)  Draft Equipment Lease(s) NYSDOH REGULATORY FILING TYPES 10

Full Review Application: Must be reviewed by the Public Health and Health Planning Council Criteria:  Renovation/Construction with Total Project costs in excess of $50M  Addition to number of beds on Operating Certificate  Changes in ownership or consolidations (regardless of cost)  Establishment of new facilities (regardless of cost) Requirements:  CON Narrative Form  Program and Need Narrative  Financial Schedules  Architect/Engineer Certification Letter  Architectural Drawings per applicable DOH Drawings Submission Guidelines  Physicist Report and Certification Letter(for radiation producing equipment)  Draft Equipment Lease(s) NYSDOH Regulatory Filing Types 11

CON Application Preparation DOH Bureau Review CON Submission to DOH Public Health Council Review (Full Reviews) Start of Construction DOH Pre-Occupancy Survey Design Development Drawing Review Project Approved Internally Schematic Drawing Review Respond to DOH Contingencies DOH Approval to Start Construction DOH Contingent Approval DOH Approval to Occupy Start End CON Kick-off Meeting Limited Reviews CON LIFE CYCLE 12

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NYP PROJECT PROCESS: PM ROLE 14

PRE-CON SUBMISSION: A/E REQUIREMENTS PROJECT ASSIGNMENT/FEASIBILITY STUDY  Review of Existing Conditions  Program and Code Review Meeting(s)  Review Code Analysis  Drawings of Proposed Space  Participation  Regulatory Planning  Regulatory Compliance  Facilities Development  Operations and Clinical Users 15

16 NYP’S CODE REVIEW PROCESS  Provide a comprehensive analysis of all applicable codes and regulations as it applies to your project.  If compliance cannot be met, what are the alternative solutions?  Applicable Codes include but not limited to:  2010 FGI Guidelines  Review ALL required Sections of the FGI Code  Functional Program Requirements  NFPA 101, Life Safety Code, 2000 edition  The Americans with Disabilities Act of 1990 (ADA) extends comprehensive civil rights protection to persons with disabilities.  NYC Building Codes  NYS Building Codes  NYCRR Title 10: Section Pertinent technical standards NYCRR Title 10: Section Pertinent technical standards

SAMPLE FGI CODE REVIEW ANALYSIS 17

NYSDOH WAIVERS (DSG-06) Waivers are required when deficiencies in the design are determined but cannot be corrected for:  2010 FGI Guidelines  NFPA 101, Life Safety Code, 2000 edition (Requires NYP Life Safety Approval)  The Americans with Disabilities Act of 1990 (ADA) Waiver Types  Permanent Waivers  Categorical Waivers  Time Limited Waivers Responsibility: Project Manager  Design Team: Architect and/or Engineer  Letters of support: Clinician and Infection Control

19 General Requirements for CON Application  Certification Letters  Self Certification  General Certification  MRI Installation  Existing Buildings  CON Narrative Form  Schematic Drawings (per DOH Drawing Submission Guidelines)  Waiver Request Form, if applicable  2010 FGI Guidelines  NFPA 101 Life Safety -Must be Reviewed and Approved by Regulatory Compliance CON SUBMISISON: A/E REQUIREMENTS

POST CON SUBMISSION: A/E REQUIREMENTS  DOH/DASNY Requests For Additional Information -Clarification on Scope -Clarification and/or updates to Drawings  Design Development Submission (DSG-02) Not for Projects Self-Certified  Final Construction Documents (DSG-05)  Interim Life Safety Measures (ILSM) Process  Infection Control Risk Assessment Measures 20

DURING CONSTRUCTION  We MUST Notify NYSDOH of Changes - Scope - Costs - Major Medical Equipment  Waiver Submissions -New Issues Uncovered during Construction  Phased Projects -DOH Survey for Each Phase that requires occupancy -Allot at least 1 Month Between Each Phase 21

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PRE-OCCUPANCY SURVEY PREPARATION 23

ROLES & RESPONSIBILITIES  Regulatory Planning - Facilitator/Liaison to Agency  Facilities Project Manager -Compiles Certification Letters and Project Documentation -Follows Up on Pending Issues with Space  Project Architect/Engineer -Lead on Describing Scope and Project Details -Provides Half Size Set of Drawings -Provides 11*17 Life Safety Drawing (2 Copies)  Project Administrator (s) – Clinical & Operations -Fire Safety Training -Policies and Procedures, Staff Training & Credentials PRE-OCCUPANCY SURVEY - ROLES 24

OPPORTUNITIES FOR IMPROVEMENT 25  Code Analysis -Ensure ALL Applicable Codes and Sections are Reviewed  Review Existing Conditions -Do Support Spaces Meet Requirements?  Documentation -Follow the DOH Drawing Submission Guidelines -Provide Detailed Narratives -Ensure CON Drawings are Consistent with Narrative  Waivers -Follow ALL Conditions Indicated in Approved Waivers

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