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

2. 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

3. 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….

4. 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

5. 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

6. THE LIFE of a TYPICAL CON

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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. PRE-OCCUPANCY SURVEY PREPARATION
8 weeks prior
Regulatory Planning will send an 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

17. 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

18. 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

19. NYP PROJECT PROCESS

20. 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

21. Q & A