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Requirements and Procedures. Notice Submissions. Part 1. Projects Covered. Equipment Replacement. Medical and Non-Medical Used for similar purposes as equipment being replaced “Substantially equivalent” technology FDA-approved, if applicable. Nonclinical Infrastructure.
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Requirements and Procedures Notice Submissions
Part 1 Projects Covered
Equipment Replacement • Medical and Non-Medical • Used for similar purposes as equipment being replaced • “Substantially equivalent” technology • FDA-approved, if applicable.
Nonclinical Infrastructure • Including but not limited to HVAC, fire alarm and call bell systems, exterior building envelope, parking garages and elevators. • Others that do not relate to: • Clinical space or service • Renovation or reconfiguration of patient rooms • Renovation or reconfiguration of resident rooms.
Non-Clinical Construction • Administrative Offices • Utility Structures • Maintenance Shop • Central Kitchen • Cafeteria • Gift Shop • Dedicated Worship Space • Hospital Lobbies
Clinical Impact • Limited Review (710.1(c)(5)) still required for projects that impact clinical space, such as • Operating rooms • Treatment and procedure rooms • ICU’s • Special care units (e. g., cardiac) • Isolation rooms • Laboratories
Clinical Impact • Limited Review (710.1(c)(5)) still required for projects to: • Renovate or reconfigure patient rooms • Renovate or reconfigure resident rooms. • Notice required for painting, replacement of floor coverings, etc., which are repair and maintenance
Part 2 Notice Submission Process
“Written” Notice • Electronic Submission via NYSE-CON
Notice Submission to NYSE-CON • Format Similar to Limited Review Application, but streamlined: • Project Description • Architecture/Engineering Certification, where applicable.
Patient Safety Plan • Required for projects that implicate patient safety • Submission of plan document required
Timing and Acknowledgements • No timeframe for submission in advance of project • No formal approval will be issued by the Department for Notices • An acknowledgement will be generated by NYSE-CON when a notice is uploaded.
Compliance • Pre-opening and /or Post-opening inspections will be conducted selectively. • All projects must be fully compliant with applicable codes and regulations. • Full citation and correction of any violations.
Certification Documents • Initial Submission: • Architect/Engineer Certification • Patient Safety Plan • Physicist Certification
Certification Documents • Project Closeout • Architect/Engineer Certification • Installer’s Certification • Balancing Report