The 2018 FGI Guidelines Proposed Revisions to Procedure, Operating, and Imaging Room Requirements

Bryan Langlands AIA, ACHA, EDAC, LEED GA The views and opinions expressed in this presentation are the opinion of the speakers and not the official position of FGI or the Health Guidelines Revision Committee. PROPOSED CHANGES TO SURGERY SECTIONS

Clarification of procedure room and operating room requirements intended to support space for equipment and staff present for procedures provided

Section 2.1-3.2.2 (H) and 3.8-3.1 (OP) Procedure Room Section 2.1-3.2.3 (H) and 3.7-3.4 (OP) Operating Room Section 2.2-3.3.4 (H) Hybrid Operating Room

New classification structure for imaging rooms based on procedures performed and environmental controls needed to allow flexibility in imaging room requirements as procedures and equipment change over time

Section 2.2-3.4.1.2 (H) and 2.1-3.5.2 (OP) Imaging Rooms Table 2.2-2 (H) 2018 FGI PROCEDURES

An understanding of the following is required to inform the planning of diagnostic, surgical, and interventional spaces.

• Level of invasiveness, likelihood of infection • Type of sedation used to conduct procedure Level of • Number of staff expected in the room during procedure Invasiveness • Equipment needed to support procedure

Infrastructure Which, in turn, determine the design requirements: Requirements Equip & Staff Type of • Room classification required Sedation Procedure room (formerly Class A) Operating room (formerly Class B & C) Type of Imaging room (new Class 1, 2, and 3) • Room size • Room finishes • Room Infrastructure (MEP systems) INVASIVE PROCEDURE

A procedure that is performed in an aseptic surgical field and penetrates the protective surfaces of a patient’s body (e.g., subcutaneous tissue, mucous membranes, cornea).

An invasive procedure may fall into one or more of the following categories:

§ Requires entry into or opening a sterile body cavity (i.e., cranium, chest, abdomen, pelvis, joint spaces) § Involves insertion of an indwelling foreign body § Includes excision and grafting of burns that cover more than 20 percent of total body area § Does not begin as an open procedure but has a risk, as determined by the physician, of requiring conversion to an open procedure 2018 GUIDELINES OBJECTIVE

• To make it easier for designers to know when what type of room is acceptable • To make it easier for designers to right-size procedure and operating rooms Task group concerns and discussions included increasing patient acuity and complexity of outpatient surgical procedures, growing number of 23-hour-stay post-procedure outpatient services, and need for consistency and standards for environments

Inpatient Operating Room Outpatient Operating Room

Minimum 400 SF

Minimum 20’ width THREE MAJOR TYPES OF ROOMS….

Procedure Imaging Room Use Room Type Type A room designated for the performance of Exam/ Class 1 patient care that may require high-level disinfected or sterile instruments but is not Treatment Imaging required to be performed with the 1 Room Room environmental controls of a procedure room. A room designated for the performance of patient care that requires high-level Class 2 Procedure disinfection or sterile instruments and Imaging some environmental controls but is not Room 2 Room required to be performed with the environmental controls of an operating room. A room that meets the requirements of a restricted area, is designated and equipped Class 3 Operating for performing surgical or other invasive Imaging room procedures, and has the environmental Room 3 (Hybrid OR) controls for an OR as indicated in ASHRAE 170. An aseptic field is required for all procedures performed in an OR. 2018 GUIDELINES MINIMUM ROOM SIZES 48 SF

48 SF (6’ x 8’) 80 SF 120 SF 130 SF 130 SF Anesthesia OP Exam Hospital Exam Procedure Room Work Area Procedure Room (WITHOUT Need for Anesthesia Equip) (WITH Need for Anesthesia Equip)

48 SF 48 SF

255 SF 270 SF 400 SF 600 SF 15’ 20’ Outpatient OR Outpatient OR Hospital OR Hybrid (WITHOUT Need for Anesthesia Equip) (WITH Need for Anesthesia Equip) (ALWAYS PLANNED for WITH Anesthesia Equip) STUDY BY AMERICAN SOCIETY OF ANESTHESIOLOGISTS Operating Room Architectural Flow Diagram

What is the minimum SF required for an Nurses Anesthesiologists Anesthesia Work Area? Surgeons Perfusionists

Realizing Improved Patient Care through Human-centered Operating Room Design: A Human Factors Methodology for Observing Flow Disruptions in the Cardiothoracic Operating Room Anesthesiology. 2013;119(5):1066-1077. doi:10.1097/ALN.0b013e31829f68cf CLEARANCE ZONE DIAGRAM Establishing the Anesthesia Work Area

Anesthesia Patient area Work Area 8’ 48 SF

6’ 8’ Anesthesia 6’ x 8’ work zone

8’

7’ GURNEY 3’ X 7’ Gurney for planning purposes 6’ x 8’ Anesthesia Work Zone at Head 3’ CLEARANCE ZONE DIAGRAM Establishing the Anesthesia Work Area Any room (Exam, Treatment, or Imaging rooms) Perimeter where general anesthesia will be administered Circulation using an anesthesia machine and supply carts 8’ shall have 48 square feet at the head of the 2’ table, gurney, or chair for an anesthesia work zone. 6’ 8’ Anesthesia 6’ x 8’ work zone

Gray and White area is 2’ area shared between anesthesia and circulator. The anesthesia work zone is a 6’ x 8’ space at the head of the table, but when the anesthesia care provider(s) are not 6’ x 8’ Anesthesia Work Zone at Head actively setting up sedation of the 2’ x 8’ at Perimeter, may serve as Circulation patient 2’ at the top of that zone can be used as part of the circulator pathway. ROOM CLASSIFICATION Environmental Controls Room Type Use Location Ventilation Surfaces

Patient care that may 4 total ACH for general exam room Exam Room require high-level 6 total ACH for exam rooms programmed for use disinfected or sterile Ceilings: Cleanable with routine housekeeping equipment or Accessed from an by patients with undiagnosed gastrointestinal instruments but does Floor: No special requirement unrestricted area symptoms, respiratory symptoms, or skin symptoms not require the Treatment No pressure requirement Walls: No special requirement Room environmental controls of a procedure room Standard diffuser and return array

Ceilings: Smooth and without crevices, scrubbable, non-absorptive, non-perforated; capable of withstanding cleaning chemicals; without Patient care that requires crevices; lay-in ceiling permitted if gasketed or each ceiling tile weighs high-level disinfection or at least one pound per square foot and no perforated, tegular, serrated, or sterile instruments and Accessed from an 15 ACH / Positive pressure highly textured tiles. Lay-in ceiling permitted if gasketed or each ceiling Procedure some environmental tile weighs at least 1lb/SF unrestricted or a Standard diffuser and return array controls but does not Room semi-restricted area Floor and wall base assemblies for cystoscopy, urology, and require the endoscopy procedure rooms: Monolithic with an integral coved wall environmental controls base that is carried up the wall a minimum of 6’ of an operating room Wall finishes for endoscopy: Free of fissures, open joints, or crevices that may retain or permit passage of dirt particles

Invasive procedures* 20 total ACH / Positive pressure Ceilings: Monolithic, scrubbable, capable of withstanding cleaning Any procedure during and/or disinfecting chemicals, gasketed access openings Accessed from a Primary supply diffuser array extend a minimum of Operating which the patient will 12’ beyond the footprint of the surgical table on Floor and wall base assemblies: Monolithic with an integral coved wall semi-restricted Room require physiological each side base that is carried up the wall a minimum of 6’ monitoring and is area At least two low sidewall return or exhaust grilles Wall finishes: Free of fissures, open joints, or crevices that may retain anticipated to require spaced at opposite corners or as far apart as possible or permit passage of dirt particles active life support EXAMINATION ROOM

A room with a bed, stretcher, or examination table and capability for periodic monitoring (e.g., measurement of blood pressure or pulse oximetry) in which procedures that do not require a specialized suite can be performed (e.g., pelvic examination).

TREATMENT ROOM A standard patient room in an emergency department (ED) or urgent care center that may be used for a variety of functions, including patient examination and various treatments or procedures, including wound packing, suture placement, or casting. This room may contain specialized equipment as identified in the functional program. EXAM ROOM CLASSIFICATION Environmental Controls Room Type Use Location Ventilation Surfaces

80 SF 120 SF

OP Exam Hospital Exam PROCEDURE ROOM

A room designated for the performance of patient care that requires high-level disinfection or sterile instruments and some environmental controls but is not required to be performed with the environmental controls of an operating room. ROOM CLASSIFICATION Environmental Controls Room Type Use Location Ventilation Surfaces

Patient area Circulation pathway where the circulator walks to perform duties. Cannot walk into sterile field. Movable equipment zone where the required movable equipment is stored and provides for door swing and opening of fixed drawers or opening of door and drawers on carts 3’

CFA Clear Floor Area - 130 SF 7’ GURNEY 3’-0” Clearance at Head & Foot 3’-6” Clearance at Sides 3’-6” 3’ 3’-6” 130 SF CFA

3’ CLEARANCE ZONE DIAGRAM PROCEDURE ROOM – INPATIENT & OUTPATIENT (WITH Need for Anesthesia Equipment) PROCEDURE ROOM ZONES WITH NEED FOR ANESTHESIA EQUIP

Patient area Circulation pathway where the circulator walks to perform duties. Cannot walk into sterile field. 2’ Movable equipment zone where the required 3’ movable equipment is stored and provides 6’ for door swing and opening of fixed drawers 48 SF or opening of door and drawers on carts 3’ 8’ Anesthesia 6’ x 8’ work zone

Gray and White area is 2’ area shared between anesthesia and circulator. CFA Clear Floor Area - 130 SF 7’ GURNEY 3’ X 7’ Gurney for planning purposes 6’ x 8’ Anesthesia Work Zone at Head 3’-6” 3’ 3’-6” 2’ x 8’ at Perimeter, may serve as Circulation 3’-0” Clearance at Head & Foot, 3’-6” Clearance at Sides 3’ 130 SF CFA + 24 SF (3’ x 8’) 2018 GUIDELINES MINIMUM ROOM SIZES Exam, Treatment & Procedure Rooms

48 SF

80 SF 120 SF 130 SF 48 SF 130 SF

OP Exam Hospital Exam Procedure Room Anesthesia Procedure Room Work Area (WITHOUT Need for (6’ x 8’) (WITH Need for Anesthesia Equip) Anesthesia Equip) 2018 GUIDELINES MINIMUM ROOM SIZES Operating Rooms

48 SF 48 SF

255 SF 270 SF 400 SF 600 SF 15’ 20’ Outpatient OR Outpatient OR Hospital OR Hybrid (WITHOUT Need for Anesthesia Equip) (WITH Need for Anesthesia Equip) (ALWAYS PLANNED for or Specialty WITH Anesthesia Equip) OPERATING ROOM

A room that meets the requirements of a restricted area, is designated and equipped for performing surgical or other invasive procedures, and has the environmental controls for an OR as indicated in ASHRAE 170. An aseptic field is required for all procedures performed in an OR. ROOM CLASSIFICATION Environmental Controls Room Type Use Location Ventilation Surfaces

Patient area Sterile field where scrub and physician work Circulation pathway where the circulator 48 SF walks to perform duties. Cannot walk into sterile field. Movable equipment zone where the required movable equipment is stored and provides for door swing and opening of fixed drawers or opening of door and drawers on carts

7’ Anesthesia 6’ x 8’ work zone OR TABLE Gray and White area is 2’ area shared between anesthesia and circulator. 2’-6” 3’ 3’ 3’ 3’ 3’ 2’-6” CFA Clear Floor Area - 400 SF

3’ 3’ X 7’ Gurney for planning purposes 3’ at Sides & Foot – Sterile Field 2’ 3’ at Sides, 2’ at Foot – Circulation 2’-6” at Sides, 2’ at Foot – Equipment 2’ 20’ Minimum Width, 400 SF Minimum CFA CFA & CLEARANCE ALLOWANCE

Revised text in 2018 FGI in order to acknowledge inevitable encroachments and other intrusions to space.

Fixed encroachments shall be permitted to be included when determining Column minimum CFA requirements for an OR encroachment provided: 1) There are no encroachments into the sterile field 2) The encroachments do not extend more than 12 inches into minimum CFA outside the sterile field 3) The encroachment width along each wall does not exceed 10 percent of the length of that wall OPERATING ROOM - OUTPATIENT WITHOUT Need for Anesthesia Equipment

Procedures (100s of) that may be Procedures that are typically performed in performed in an OR environment but may an OR environment but may only require only require Local Anesthesia (numbing Local w/ Sedation (MAC – Monitored medication), and do not necessarily have Anesthesia Care) and do not necessarily need for extensive anesthesia equipment: have need for anesthesia extensive equipment:

• Small excision • Carpal tunnel • Cosmetic procedures • Cataract removal • Eyebrow lift • Cystoscopy • Blepharoplasty • Hysteroscopy • Podiatry • Bunionectomy • Hammertoe correction • Hand procedures • Excisions of small mass CLEARANCE ZONE DIAGRAM OPERATING ROOM – OUTPATIENT (WITHOUT Need for Anesthesia Equipment) OUTPATIENT OR ZONES W/O NEED FOR ANESTHIA EQUIPMENT

Patient area

15’ Sterile field where scrub and physician work

Circulation pathway and movable equipment zone

3’ CFA Clear Floor Area - 250 SF

7’ OR TABLE

3’ 3’ 3’ 3’ 3’ 3’ X 7’ Gurney for planning purposes 3’ at Sides & 3’ Foot & Head – Sterile Field 3’ 3’ at Sides & 2’ Foot – Circ. & Equip 15’ Minimum Width, 255 SF Minimum CFA 2’ OPERATING ROOM - OUTPATIENT WITH Need for Anesthesia Equipment

Procedures that are typically performed in Procedures that are typically performed in an OR environment but could use general an OR environment requiring “intubation” medication propofol or mask, but have a or using gas anesthesia (sevoflurane) greater risk of requiring emergency care requiring anesthesia machine with vent where access to full anesthesia care and capability: equipment is advised:

• Breast augmentation • Extended abdominoplasty • Mini tummy tuck • Shoulder arthroscopy • Knee arthroscopy • Partial knee replacement • Laparoscopy • Spinal fusion • Cysto with holmium laser lithotripsy • Pediatric tonsillectomy CLEARANCE ZONE DIAGRAM OPERATING ROOM – OUTPATIENT (WITH Need for Anesthesia Equipment) OUTPATIENT OR ZONES WITH NEED FOR ANESTHIA EQUIPMENT 15’ Patient area

Sterile field where scrub and physician work

Circulation pathway and 1’-6” movable equipment zone

48 SF CFA Clear Floor Area - 270 SF 3’

7’ OR TABLE

3’ 3’ 3’ 3’ 3’ 3’ X 7’ Gurney for planning purposes 3’ at Sides & 3’ Foot & Head – Sterile Field 3’ 6’ x 8’ Anesthesia Work Zone at Head 3’ at Sides & 2’ at Foot – Circ. & Equip 2’ 15’ Minimum Width, 270 SF Minimum CFA IMAGING ROOM CLASSIFICATION

Environmental Controls Room Type Use Location Ventilation Surfaces • Diagnostic radiography, fluoroscopy, mammography, computed tomography Ceilings: Cleanable with routine housekeeping equipment; lay-in ceiling Class 1 (CT), ultrasound, magnetic resonance Accessed from 6 total ACH permitted imaging (MRI), and other imaging an No pressure requirement Floor: Cleanable and wear-resistant for the location; stable, firm, and slip- Imaging modalities unrestricted resistant Room • Services that utilize natural orifice entry area Standard diffuser and return array and do not pierce or penetrate natural Walls: Washable protective membranes Ceiling: Smooth and without crevices, scrubbable, non-absorptive, non- perforated; capable of withstanding cleaning chemicals; without crevices; lay-in ceiling permitted if gasketed or each ceiling tile weighs at least one 15 total ACH pound per square foot and no perforated, tegular, serrated, or highly textured • Diagnostic and therapeutic procedures Accessed from Class 2 Positive pressure for catheterization tiles such as coronary, neurological, or an Imaging peripheral angiography unrestricted No pressure requirements for other Flooring: Cleanable and wear-resistant for the location; stable, firm, and Room or a semi- rooms slip-resistant • Electrophysiology procedures restricted area Standard diffuser and return array Floor and wall base assemblies: Monolithic floor with integral coved wall base carried up the wall a minimum of 6 inches Wall finishes: Washable; free of fissures, open joints, or crevices

Class 3 20 total ACH, Positive pressure Ceiling: Monolithic, scrubbable, capable of withstanding cleaning and/or disinfecting chemicals, gasketed access openings Imaging • Invasive procedures* Primary supply diffuser array extend a Accessed minimum of 12’ beyond the footprint of Flooring: Cleanable and wear-resistant for the location; stable, firm, and room • Any Class 2 procedure during which the from a semi- the surgical table on each side slip-resistant patient will require physiological restricted (Hybrid monitoring and is anticipated to require area At least two low sidewall return or Floor and wall base assemblies: Monolithic floor with integral coved wall Operating active life support exhaust grilles spaced at opposite base carried up the wall a minimum of 6 inches Room) corners or as far apart as possible Wall finishes: Washable; free of fissures, open joints, or crevices IMAGING ROOM CLASSIFICATION

An imaging room is a room in which imaging services are provided.

Depending on what takes place within the imaging room, the room maybe used for diagnostic, therapeutic, or invasive procedures, and as such should be designed to the same standards as required for those same procedures to take place in non-imaging settings.

Proposed new classification system for Imaging rooms.

T30 April 4 + 5, 2017 | 2018 FGI Guidelines: A New Class Act COMPARISON Exam/Treatment Room & Class 1 Imaging Room Environmental Controls Room Type Use Location Ventilation Surfaces

Diagnostic radiography, fluoroscopy, Ceilings: Cleanable with routine mammography, computed tomography (CT), housekeeping equipment; lay-in ceiling 6 total ACH Class 1 ultrasound, magnetic resonance imaging permitted (MRI), and other imaging modalities No pressure requirement Imaging Floor: Cleanable and wear-resistant for the Room Services that utilize natural orifice entry and Standard diffuser and return array location; stable, firm, and slip-resistant do not pierce or penetrate natural protective Walls: Washable membranes

Accessed from an unrestricted 4 total ACH for general exam area room Exam Room 6 total ACH for exam rooms Patient care that may require high-level programmed for use by patients Ceilings: Cleanable with routine housekeeping equipment or disinfected or sterile instruments but does not with undiagnosed gastrointestinal require the environmental controls of a symptoms, respiratory Floor: No special requirement Treatment symptoms, or skin symptoms procedure room Walls: No special requirement Room No pressure requirement Standard diffuser and return array COMPARISON Procedure Room & Class 2 Imaging Room Environmental Controls Room Type Use Location Ventilation Surfaces Ceiling: Smooth and without crevices, scrubbable, non-absorptive, non-perforated; capable of withstanding cleaning chemicals; without crevices; lay-in ceiling permitted if gasketed or each ceiling tile weighs 15 total ACH Diagnostic and therapeutic at least one pound per square foot and no perforated, tegular, serrated, procedures such as coronary, Positive pressure for catheterization or highly textured tiles Class 2 neurological, or peripheral No pressure requirements for other Flooring: Cleanable and wear-resistant for the location; stable, firm, Imaging Room angiography rooms and slip-resistant Electrophysiology procedures Standard diffuser and return array Floor and wall base assemblies: Monolithic floor with integral coved wall base carried up the wall a minimum of 6 inches Wall finishes: Washable; free of fissures, open joints, or crevices Accessed from an unrestricted or a semi-restricted Ceilings: Smooth and without crevices, scrubbable, non-absorptive, area non-perforated; capable of withstanding cleaning chemicals; without crevices; lay-in ceiling permitted if gasketed or each ceiling tile weighs Patient care that requires high- 15 ACH at least one pound per square foot and no perforated, tegular, serrated, level disinfection or sterile or highly textured tiles. Lay-in ceiling permitted if gasketed or each Procedure instruments and some Positive pressure ceiling tile weighs at least 1lb/SF Room environmental controls but does Standard diffuser and return array Floor and wall base assemblies for cystoscopy, urology, and not require the environmental endoscopy procedure rooms: Monolithic with an integral coved wall controls of an operating room base that is carried up the wall a minimum of 6’ Wall finishes for endoscopy: Free of fissures, open joints, or crevices that may retain or permit passage of dirt particles HYBRID OPERATING ROOM

A room that meets the definition of an operating room and is also equipped to enable diagnostic imaging before, during, and after surgical procedures.

Imaging equipment is permanently installed in the room and may include MRI, fixed single-plane and bi-plane tomographic imaging systems, and computed tomography equipment.

Note: Use of portable imaging technology does not make an OR a hybrid operating room. COMPARISON Operating Room & Class 3 Imaging Room Environmental Controls Room Type Use Location Ventilation Surfaces

Ceiling: Monolithic, scrubbable, capable of withstanding cleaning and/or disinfecting Class 3 chemicals, gasketed access openings Invasive procedures* Imaging Flooring: Cleanable and wear-resistant for the room Any Class 2 procedure during which the location; stable, firm, and slip-resistant patient will require physiological monitoring (Hybrid Floor and wall base assemblies: Monolithic and is anticipated to require active life floor with integral coved wall base carried up Operating support 20 total ACH, Positive pressure the wall a minimum of 6 inches Room) Primary supply diffuser array Wall finishes: Washable; free of fissures, open joints, or crevices Accessed from extend a minimum of 12’ beyond the footprint of the surgical table a semi- on each side restricted area At least two low sidewall return or Ceilings: Monolithic, scrubbable, capable of exhaust grilles spaced at opposite withstanding cleaning and/or disinfecting corners or as far apart as possible chemicals, gasketed access openings Invasive procedures* Operating Floor and wall base assemblies: Monolithic Any procedure during which the patient will with an integral coved wall base that is carried Room require physiological monitoring and is up the wall a minimum of 6’ anticipated to require active life support Wall finishes: Free of fissures, open joints, or crevices that may retain or permit passage of dirt particles THREE MAJOR TYPES OF ROOMS….

Level of Risk of Sterility of Infrastructure Invasiveness Infection Environment Room Finishes

Level of Non Low Low, Low Invasiveness 1 Invasive 4-6 ACH

Infrastructure Requirements Equip & Staff Type of Limited 15 ACH required Sedation 2

Invasive, High High, 20 High 3 Any ACH 2018 FGI PROCEDURES – SUMMARY Size of Room

Number of Type of Amount of Minimum Staff Req’d Sedation Equipment Room Size

Level of Low None Limited 80-120 SF Invasiveness 1

Infrastructure Requirements Equip & Staff Type of Varies, may 15 ACH 130 SF required Sedation 2 be General

General High High 255 SF OP Anesthesia 3 400 SF IP