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

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

3. 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

4. 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
Health care facilities must file an application and obtain approval before….

5. 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
Self Certification exclusion expanded:
Surgical Suites and Special Procedure Rooms now include:
a. Endoscopy
Class “B” and Class “C” Operating Rooms
Interventional Imaging
Located in procedure rooms
Located in operating rooms

6. Q & A

7. (Exclusive of DASNY Fee)
NYSDOH REGULATORY FILING TYPES
REVIEW TYPE
COST THRESHOLD
ORP PREPARATION TIME
DOH
APPROVAL TIME
APPLICATION FEE
(Paid by ORP)
PROCESSING FEE
(Exclusive of DASNY Fee)
Construction Notice
None
2 Weeks Prior to Start
No Approval Timeframe $0
Limited Review
< $6M
3 Weeks
~ 8 Weeks
$1,000
Administrative Review
$6M through
< $50M*
4 Weeks
~ 6-8 Months
$2,000
.30% of Total Project Costs
Full Review
> $50M*
.55% of Total Project Costs
* Varies by Facility

8. NYSDOH REGULATORY FILING TYPES
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
EXAMPLES –
Infrastructure – HVAC, Plumbing, Sprinkler, Electrical, Fire Alarm, Suppression Systems, Chillers, Call Bell, Elevators, Energy Producing Equipment, Roofs, Parking Lots
Equipment replacement:
Radiation Producing Equipment Replacement- Examples include: MRI, Gamma Camera, Nuclear Medicine Camera, CT Scanner, C-Arm,, Mammography Unit, X-Ray Unit, Ultrasound Equipment
General Related Equipment: OR Robotic Device
Cosmetic Renovations: high dollar value refurbishments and upgrades to floor, ceiling, walls
General repair or maintenance-Usually large scale OFO projects
CON Narrative Form-Detailed Narrative; Description of existing conditions, proposed scope, MEP scope, Building type, Construction Type, Square Footage, Construction Schedule, Decanting Phase (if required).

9. NYSDOH REGULATORY FILING TYPES
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)
LIMETED REVIEW EXAMPLES
Columbia Campus Example:
Organ Recovery Unit Xvivo on Heart 3
Weill Cornell Campus Example:
Sackler Gift GP2S

10. NYSDOH REGULATORY FILING TYPES
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)
ADMINISTRATIVE REVIEWEXAMPLES –
Columbia Campus:
Dialysis Suite on MHB-1HN
Weill Cornell Campus:
PACU on M3

11. NYSDOH Regulatory Filing Types
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)
Full Review EXAMPLES:
Columbia Campus:
Cardiac NICU on 9 North in MSCHONY
Weill Cornell Campus:
Certify 21 West Broadway

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

13. Q & A

14. NYP PROJECT PROCESS: PM ROLE

15. 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

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 711.2 - Pertinent technical standards
Includes reiteration of guideline or code. Ensure to include appendices, or any referenced sections within the text of the code.
Describe the existing conditions and whether or not the project will comply.

17. SAMPLE FGI CODE REVIEW ANALYSIS

18. 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
TYPES OF WAIVERS
Permanent waivers are granted when a deficiency is determined not to be detrimental to the health and safety of the occupants. Permanent waivers do not require CMS approval. Permanent waivers are typically used for FGI and ADAAG compliance.
Provide the following information when applicable to provide sufficient documentation to the existing conditions of the deficiency.
O Photographs
Interior (where applicable.)
Exterior (where applicable.)
O Floor plans to scale and highlight area of deficiency (with dimensions, where applicable.)
O Building elevations and building sections (where applicable.)
O Wall sections (where applicable.)
o Technical investigation of as-built conditions and preparation of supporting documentation
(such as calculations) by a licensed design professional to provide verification that the code
has been met.
Categorical waivers are established by CMS.
CMS issues Survey & Certification (S&C) memos to allow facilities to use specified portions of a later edition of the Life Safety Code.
Provide the following for a Categorical waiver:
Survey and Certification Letter from CMS.
Plans, including but not limited to LSC drawings.
Photographs
Time-limited waivers.
Determinations of waiver approval may be ‘time limited’ or temporary. The specified period of approval is to allow the facility sufficient time to implement a strategy to correct the deficiency.
Time Limited waivers can be applied for the following:
Life Safety Code deficiencies (Requires CMS approval.)
FGI deficiencies (Generally, do not require CMS approval, exceptions do apply to certain facility types)
ADAAG deficiencies (Do not require CMS approval.)
The Bureau requires facilities to establish a schedule of interim submissions and reviews to be conducted by BAER. These corrections will establish interim requirements such as milestones over an extended period of time for all major components requiring corrective action.

19. CON SUBMISISON: A/E REQUIREMENTS
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

20. 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

21. 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

22. Q & A

23. PRE-OCCUPANCY SURVEY PREPARATION

24. PRE-OCCUPANCY SURVEY - ROLES
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
Indicate all other participants

25. OPPORTUNITIES FOR IMPROVEMENT
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

28. Q & A