Attachment 2 - Surgical Design Guide.pdf

Surgical Services

November 2015

Surgical and Endovascular

Services Design Guide

April 2016 (Rev 2/17, 5/17, 7/17, 5/18, 11/18, 3/19, 7/19, 4/20, 9/21)

TABLE OF CONTENTS i

Surgical and Endovascular Services Design Guide April 2016 (rev 9/21)

TABLE OF CONTENTS

1.0 GENERAL Page

1.1. Foreword 1-1

1.2. Acknowledgements 1-3

1.3. Introduction 1-5

1.4. VA Policies/Standards, and Industry Codes/Standards 1-5

1.5. Abbreviations 1-7

2.0 2.0 NARRATIVENARRATIVE

2.1. 2.1. GeneralGeneral 2-12-1

2.1.1. 2.1.1. Clinical and Operational Summary 2-1Clinical and Operational Summary 2-1

2.1.2. 2.1.2. VA Trends in Surgical and Interventional Service 2-25VA Trends in Surgical and Interventional Service 2-25

2.2. 2.2. Technical Considerations 2-27Technical Considerations 2-27

2.2.1. 2.2.1. VA Policies/Directives/Handbooks, Codes, and Standards 2-27VA Policies/Directives/Handbooks, Codes, and Standards 2-27

2.2.2. 2.2.2. Architectural 2-29Architectural 2-29

2.2.3. 2.2.3. Interior Design 2-31Interior Design 2-31

2.2.4. 2.2.4. Heating, Ventilation and Air Conditioning Systems (HVAC) 2-31Heating, Ventilation and Air Conditioning Systems (HVAC) 2-31

2.2.5. 2.2.5. Plumbing Systems 2-35Plumbing Systems 2-35

2.2.6. 2.2.6. Lighting and Power Systems 2-38Lighting and Power Systems 2-38

2.2.7. 2.2.7. Telecommunications, and Special Telecommunication Telecommunications, and Special Telecommunication

Systems, Monitoring and Signal Systems 2-40Systems, Monitoring and Signal Systems 2-40

2.2.8. 2.2.8. Fire Protection and Life Safety 2-43Fire Protection and Life Safety 2-43

3.0 FUNCTIONAL DIAGRAMS

3.1. General 3-1

3.2. The Surgical Suite 3-7

3.3. Clean Core 3-16

4.0 DESIGN STANDARD PLATES – FLOOR PLANS, REFLECTED CEILING PLANS,

ROOM DATA SHEET, EQUIPMENT LIST & GENERAL NOTES

4.1. General 4-1

4.2. Patient Bay, Pre-Operative Holding /

Phase II Recovery (RRPR1) 4-5

4.3. Patient Room, Pre-Operative Holding /

Phase II Recovery (RRPR2) 4-16

4.4. Clean Workroom, Anesthesia (ANCW2) 4-27

4.5. Operating Room, General (ORGS1) 4-34

4.6. Operating Room, Orthopedic (OROS1) 4-50

4.7. Operating Room, Urology / Cystoscopy (ORCS1) 4-67

4.8. 4.8. Operating Room, Cardiothoracic (ORCT1) 4-84Operating Room, Cardiothoracic (ORCT1) 4-84

4.9. Pump Room, Cardiothoracic / Hybrid OR (ORHL1) 4-103

4.10. 4.10. Operating Room, Neurosurgical (ORNS1) 4-112Operating Room, Neurosurgical (ORNS1) 4-112

4.11. Operating Room, Robotics (ORRB1) 4-130

TABLE OF CONTENTS ii

4.12. 4.12. Operating Room, Transplant (ORTR1) 4-147Operating Room, Transplant (ORTR1) 4-147

4.13. Operating Room, Monoplane Hybrid (ORHY1) 4-165

4.14. Operating Room, Biplane Hybrid (ORHY2) 4-186

4.15. Control Room, Hybrid OR (ORHC1) 4-207

4.16. 4.16. Cardiac Catheterization Laboratory (XCCE1) 4-216Cardiac Catheterization Laboratory (XCCE1) 4-216

4.17. 4.17. Procedure Room, Electrophysiology (XCEP1) 4-233Procedure Room, Electrophysiology (XCEP1) 4-233

4.18. 4.18. Transesophageal Echocardiograph (TEE) Procedure Room Transesophageal Echocardiograph (TEE) Procedure Room

(TRTE1) 4-251(TRTE1) 4-251

4.19. Decontamination, TEE Probe (TRTE2)

Storage, Clean TEE Probe (TRTE3) 4-264

4.20. Immediate Use Sterilization Room (ORSR1) 4-273

4.21. Patient Bay, PACU / Phase I Recovery (RRBP1) 4-281

4.22. Airborne Infection Isolation (AII), Patient Room

PACU / Phase I Recovery (RRIR1) 4-290

4.23. Laboratory, Frozen Section (LBUL1) 4-304

4.24. Utility Room, Surgical Soiled (USCL7) 4-314

5.0 APPENDIX

5.1. Checklist for Cardiac Hybrid OR, Cardiac Catherization/

Electrophysiology Lab 5-1

5.2. Site Tours 5-9

5.2.1. Elmhurst Memorial Hospital, Elmhurst, Illinois 5-10

5.2.2. Advocate Sherman Hospital, Elgin, Illinois 5-22

5.2.3. Center for Care and Discovery, Chicago, Illinois 5-32

5.2.4. Rush University Medical Center, Chicago, Illinois 5-46

5.2.5. Edward Hines, Jr. VA Hospital, Hines, Illinois 5-56

5.3. The Interventional Suite 5-63

1-1

GENERAL

1.0 GENERAL

1.1. Foreword

The material contained in the Surgical and Endovascular Services Design Guide is the culmination of a partnering effort within the Department of Veterans Affairs by the Veterans Health Administration and the Office of Construction and Facilities Management – Office of Facilities Planning (003C2). The goal of this Design Guide is to facilitate the design process and to ensure the quality of VA facilities while controlling construction and operating costs.

Disclaimer: Products and materials indicated are for illustrations, they are not endorsement for any specific product. This document is intended to be used as the standard for design, and to supplement current VA construction standards and other VA criteria in planning surgical and endovascular space.

Designers shall use this Design Guide as closely as possible to its context and intent. Use of this Design Guide does not preclude the need for a functional and physical design parameter for each specific project. It is the responsibility of the Project Architect and the Project Engineer to develop a complete and accurate project design that best meets the users’ needs and applicable code requirements.

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Surgical and Endovascular Services Design Guide April 2016 (rev 4/20)

GENERAL

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GENERAL

1.2. Acknowledgements

Credit is due to the following individuals whose leadership, knowledge, skills, and ability made this document possible:

• Department of Veterans Affairs - Veterans Health Administration

Mark A. Wilson, MD, PhD National Director of Surgery Chief of Surgery and Medical Director, Surgical Service, VA Pittsburgh Healthcare System

John Sum-Ping, MD Director, Anesthesia Services, Chair of National Anesthesia Service

William Nylander, MD, MBA Deputy National Director of Surgical Services, VA Tennessee Valley Health System, Nashville, TN

Rick Shunk, MD Director, Interventional Cardiology, San Francisco VA Health Care System, San Francisco, CA

Grit A. Adler, MD Chief, Interventional Radiology, James A. Haley Veterans’ Hospital, Tampa, FL

Cathy Clark, RN, RCIS, MS National Cardiology Nurse Manager, Denver VA Medical Center, Denver, CO

Lisa Warner, Clinical Nurse Advisor for Perioperative RN, MHA, CNOR Services

Susan LeSuer, RN Chief Nurse, Minneapolis VA Medical Center, Minneapolis, MN

Julie Wagner, RN, CNOR Nurse Manager, Minneapolis VA Medical Center Minneapolis, MN

Melissa Batt, RN Nurse Manager, Cardiology, VA Medical Center, Salt Lake City, UT

April Dierickx Assistant Nurse Manager, Cardiology, W. G.

(Bill) Hefner VA Medical Center, Salisbury, NC

Daniel Pap, CCT, RCIS,RCES Certified Cardiographic Technician, John D. Dingell VA Medical Center, Detroit, MI

1-4

GENERAL

• Office of Construction & Facilities Management (003C)

Michael Brennan, PhD, AIA Executive Director, Office of Construction & Facilities Management

Associate Executive Director, Office of Facilities Planning

Director, Facilities Standards Service

Senior Healthcare Architect Subject Matter Expert: Surgical and Interventional Radiology Planning and Design

Architect Planner

Senior Medical Equipment Planner, Subject Matter Expert: SEPS

Senior Electrical Engineer, Subject Matter Expert: Electrical and Lighting

Senior Mechanical Engineer, Subject Matter Expert: Medical Gases

Ross Davidson, Assoc. AIA

Donald L. Myers, AIA, Zoltán John Nagy, RA

NCARB, AAH, AORN

Elizabeth Yo, RA, NCARB

Jacob J. Brown

Lam Vu, PE, MBA

Michael Taylor, PE

Don Walden Senior Mechanical Engineer, Subject Matter Expert: HVAC

• Consultants

Ronald Villasante, RA, MA Principal in Charge, Space and Equipment Planning System, HDR Architecture, Arlington, VA

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GENERAL

1.3. Introduction

The Surgical and Endovascular Services Design Guide was developed as a design tool to assist VA clinical, contracting, planning, construction and engineering staff to better understand the design process, and to better enhance their collaboration with the design team throughout the planning and design phases of a specific project.

This Design Guide is not intended to be project-specific. It addresses the general space and equipment planning, as well as functional and technical requirements of the Surgical and Endovascular Suite. While this document incorporates strategies to address adaptability, it is not possible to foresee all future requirements. It is important to note that the Section 4 – Design Guide Templates presents generic graphic representations illustrating space, equipment and related engineered system needs. They are not intended to limit design opportunities and adaptations.

The A/E design team shall read, understand and be familiar with the most current editions of the applicable VA and applicable industry’s codes and standards.

Codes and standards shown in this document shall be adhered to. VA design and construction standards may be accessed at the Office of Construction and Facilities Management’s Technical Information Library (TIL) (www.cfm.va.gov/TIL).

Use of this Design Guide does not supersede the project A/E’s responsibilities to develop a complete and accurate design that meets the users’ needs and appropriate code requirements within the budget and schedule constraints. A/E shall confirm and verify actual dimensions, weights, and utility requirements of equipment with manufacturers.

1.4. VA Policies/Standards, and Industry Codes/Standards

• VA Policies/Standards:

1. Master Construction Specifications PG 18-1

2. Design and Construction Procedures PG 18-3 (refer to Topic 1 for the list of Codes, Standards, and Executive Orders)

3. Standard Details PG 18-4

4. Equipment Guide List PG 18-5

5. Seismic Design Requirements H 18-8

6. Refer to the following PG 18-9 Space Planning Criteria Chapters that also may require space in Surgical Services:

7. Various Design Manuals PG 18-10 and technical criteria pertaining to Architectural, HVAC, Plumbing, and Electrical

8. Barrier-Free Design Standard PG 18-13

9. Room Finishes, Door, and Hardware Schedule PG 18-14

10. VHA Handbook 1102.01 http://www.cfm.va.gov/TIL

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GENERAL

11. Consensus Information from various VA medical centers

12. VHA Directive 2010-018 Facility Infrastructure Requirements to Perform

Standard, Intermediate, or Complex Surgical Procedures

• Industry Codes/ Standards

1. AORN Guidelines for Perioperative Practice

2. American College of Surgeons Guidelines

3. American College of Anesthesiologists (ASA)

4. American College of Radiology

5. Society of Interventional Radiology

6. ANSI/AAMI/IEC 80601-2-77, Medical electrical equipment -- Part 2-77:

Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment.

7. ANSI/AAMI/IEC 80601-2-78, Medical electrical equipment -- Part 2-78:

Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation.

• The Healthcare Insurance Portability and Accountability Act of 1996 (HIPAA) protects an individual’s rights to audible as well as visual privacy. This is especially the case with respect to protection of each individual’s medical records, private information and communications. The law protects all conversations between patients and admission interviewers, caregivers, nurses, physicians and families. ARRA passed by U.S. government in 2009 enacts special provisions and legal enforcement tools for patient privacy, protection and security. Office of Civil Rights (OCR) monitors HIPAA security rule compliance based on ARRA provisions. Current penalties that can be implied by OCR for non-compliance with HIPAA are divided in four categories:

(i) without knowledge; (ii) based on reasonable cause; (iii) willful neglect and

(iv) willful neglect, not corrected. Penalties differ per violation versus maximum penalty according to these four categories and vary between $100 and up to $1,500,000.

• Disaster Planning: Situations can arise in which it may not be feasible to evacuate patients for extended periods of time. In those cases, emergency electrical power will be required to maintain seamless equipment operation, heating, ventilating and vertical transportation systems, and life safety systems. This is especially important to keep the patient population reasonably comfortable and safe. This Design Guide recommends that the project consider planning for this contingency in order to care for the veteran population especially when the facility is located in an area where a high probability of threat exists from natural disasters such as hurricanes and earthquakes.

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GENERAL

1.5. Abbreviations

A, MA Air, Medical Air ABA Architectural Barriers Act ADA Americans with Disabilities Act AFF Above Finished Floor AR As Required ASC Ambulatory Surgery Center AT Acoustical Ceiling Tile AT (SP) Acoustical Ceiling Tile (with Sprayed Plastic Finish) BC Base Cabinet C Degree Celsius CC Contractor Furnished, Contractor Installed CFM Cubic Feet per Minute VA-CFM Office of Construction & Facilities Management CLG Ceiling CO2 Carbon Dioxide CP Carpet (without cushion broadloom) CRS Corrosion Resisting Steel (SS) CT Ceramic Tile DG Design Guide DS Door Switch EES Essential Electrical System EMER Emergency F Degrees Fahrenheit FC Foot-candle FD Floor Drain FIXT Fixture FLUOR Fluorescent FMS Facilities Management Service GFI Ground Fault Circuit Interrupter GWB Gypsum Wallboard HAC Housekeeping Aids Closet HIPAA Health Insurance Portability and Accountability Act of 1996 HVAC Heating, Ventilating and Air Conditioning HP Horsepower HR Hour IPS Isolation Power System IUSS Immediate Use Steam Sterilization JSN Joint Services Number kW Kilowatt LED Light Emitting Diode LB Pound/Pounds LLTS Lockers, Lounges, Toilets & Showers MATV Master Antenna Television

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GENERAL

MCS Master Construction Specifications MID Motion Intrusion Detection MTD Mounted NFPA National Fire Protection Association NSF Net Square Feet NSM Net Square Meters O Oxygen OCFM Office of Construction & Facilities Management OIT Office of Information & Technology OR Operating Room PACS Picture Archiving and Communication System PACU Post Anesthesia Care Unit PH Phase PFD Program for Design PSDM Physical Security Design Manual RB Resilient Base RCP Reflected Ceiling Plan RES Resinous Flooring RF Radio Frequency RPS Radio Paging System RSF Resilient Sheet Flooring SC High Build Glazed Coating (Special Coating) SD Standard Detail SF Square Feet, Square Foot SOPC Satellite Outpatient Clinic SP Special Faced STC Sound Transmission Class TAVR Transcatheter Aortic Valve Replacement TEE Transesophageal Echocardiography UPS Uniterruptible Power Supply V Volts V, MV Medical Vacuum VA Department of Veterans Affairs VACO Veterans Affairs Central Office VAMC Veterans Affairs Medical Center VC VA Furnished, Contractor Installed VHA Veterans Health Administration VISN Veterans Integrated Health Network VTEL Video Teleconferencing VV VA Furnished, VA Installed W Watts WSF Welded Seam Sheet Flooring

NARRATIVE 2-1

2.0 NARRATIVE

2.1. General

2.1.1. Clinical and Operational Summary

Surgical Complexity Categories It is Veterans Health Administration (VHA) policy that each VA medical facility with an inpatient Surgical Program have a surgical complexity designation, which is based upon the facility infrastructure, and that the scheduled (non-emergent) surgical procedures performed are not to exceed the infrastructure capabilities of the facility unless an emergency condition arises. A facility infrastructure refers to all aspects of surgical services: diagnostic evaluation;

consultation; surgeon and operating room clinical staffing; operating room staffing, instruments, equipment, radiology and anesthesia services; post anesthesia care unit; intensive care unit; patient ward; sterile processing service and logistics (SPS); and other surgery-related support services related to a surgical procedure. Refer to VHA Directive 2010-018 Facility Infrastructure Requirements to Perform Standard, Intermediate, or Complex Surgical Procedures for definitions of complexity designations.

The complexity designations are as follows:

1. Standard Surgical Complexity

2. Intermediate Surgical Complexity

3. Complex Surgical Complexity

Surgical procedures occurring in an Ambulatory Surgical Center (ASC) program are assigned a complexity designation of either Basic or Advanced.

Every effort must be made to select appropriate patients who are suitable to have their procedure performed in an ASC. Patients must be discharged from the ASC according to an established protocol, or must be transferred to a facility with 24-hour observation and inpatient surgical services.

Surgical procedures are classified by complexity, which is available both in the Surgical Complexity Matrix (SCM) and the Ambulatory Surgical Complexity Matrix (ASCM) and in a web-based tool, the Current Procedural Terminology (CPT) Look-Up.

General Description, Function and Concepts Most VAMCs are affiliated with major medical, nursing and allied health universities, colleges, and schools. As part of the education, medical residents, nursing and allied health students are trained in VAMCs. For this reason, additional space is required in the Surgical Operating and Endovascular Procedure rooms. Additionally, staff support areas need to be expanded to accommodate faculty and students. Moreover, process of teaching and learning may cause surgical procedures to be longer. This additional space and time must be taken into consideration when determining the size and number of surgery and endovascular support spaces for a teaching VAMC.

NARRATIVE 2-2

Surgical Department The Surgical Department is comprised of all functional areas required for patient surgical services. It includes the Surgical and Endovascular Procedure Suites, Pre-procedure Assessment, Pre-Operative Holding, Post Anesthesia Care Unit (PACU), and Phase II Recovery.

Recently there has been a shift toward one integrated interventional platform consolidating surgical and invasive cardiovascular services directly adjacent to each other. By utilizing the same aseptic environment this concept maximizes efficiency by sharing resources, and promotes quality outcomes and patient safety. The Surgical and Endovascular Services Design Guide includes templates for new Cardiac Catheterization, Electrophysiology, Vascular Surgery, and Interventional Radiology Procedure Rooms, and Transesophageal Echocardiograph (TEE) Rooms, which will be collocated with Surgical Services and share the same semi-restricted area and adjacent support spaces.

This Design Guide is intended for facilities of the following acuity levels:

Ambulatory, Standard, Intermediate, and Complex Centers. The net square feet (NSF) that is indicated within the design plate templates and the SEPS Chapter 286 Surgical and Endovascular Services (https://www.cfm.va.gov/ til/space/spChapter286.pdf) space planning criteria are to be followed in design intent and spirit to the greatest extent possible.

The Surgical Suite The Surgical and Integrated Suite is a group of spaces consisting of the individual operating rooms in which surgery is performed, plus all the required support areas. These support areas include the Clean Core, a semi-restricted corridor and the following spaces:

• Control and Communication Area; Patient Holding/ Prep

• Staff Lockers and Lounge, Toilets and Showers (LLTS) including the

Auto-Valet scrub suit dispensing machines

• Anesthesia Workroom

• Scrub Areas for the staff

• Blood Gas Analysis Laboratory

• Immediate Sterilization serving a pod of Operating Rooms **

• Equipment Storage Space

• Connection to the sterile processing service and logistics (SPS) -usually via mechanical cart lifts or elevators

• Medical Gas Storage Area

• Dedicated Housekeeping Aides Closets (HAC) for the semi-restricted area.

• Appropriate Administrative Areas, including Charge Nurse Office, and

Surgical and Anesthesia Offices as required for supervision

• Other support areas as deemed appropriate.

https://www.cfm.va.gov/til/space/spChapter286.pdf

NARRATIVE 2-3

** As a safety priority SPS adheres to is upholding the goal of “0” percent use of Immediate Use Steam Sterilization (IUSS). IUSS describes steam sterilization cycles in which unwrapped medical instruments are subjected to an abbreviated steam exposure time and then used promptly after cycle completion. The ability to maintain adequate par levels of all sterile processing supplies help facilitate the decreased need for IUSS sterilization.

The Surgical Suite: The perioperative journey, clinical staff, the patient and support staff.

Surgical Staff: The staff typically moves from the staff lockers/lounge through the semi-restricted corridor to the Scrub Stations and then into the individual Operating Rooms, with exit through the semi-restricted corridor.

Possible exceptions to this flow are the “circulators,” who retrieve supplies and equipment from the clean core, and the supervising anesthesia staff, who are permitted to move from Operating Room to Operating Room via the clean core.

Patient: The Patient checks in and changes into a gown in the pre-procedure area. They are then visited by members of the surgical team, who will start an intravenous (IV) line, review the procedure and answer any questions the patient may have. They are then brought into the operating room on a gurney and transferred to the operating table. While the patient is awake during this process, the anesthesiologist may have given the patient a drug to help them relax. Once situated on the operating table, the anesthesiologist will give the patient drugs through their IV and a breathing mask to induce anesthesia. When the patient is asleep the surgical procedure begins. Once the surgery is complete the patient is moved to the post-anesthesia care unit (PACU) until the effects of the anesthesia wear off. Outpatients will go to the Phase 2 recovery area, where a designated family member can come and visit with the patient while they become more alert and are discharged to go home. Inpatients will be transferred to a patient ward until they are discharged.

Linens: Linens are brought into the Surgical Operating Rooms and Endovascular Procedure Rooms by way of the semi-restricted corridor.

Soiled linen is bagged and removed from each Surgical Operating Room and Endovascular Procedure Room via the semi-restricted corridor.

The “Sterile Field” In general, the term “sterile field” is used to describe the sterile zone in the Operating and or Endovascular Procedure Room is approximately five feet around the perimeter of the surgical table, which includes the space surrounding the site of the patient’s incision. The term “sterile” indicates that no undesirable microorganisms are present. The hands of the scrub team are gloved and everything that enters this field must be sterile. The operating table, the surgical instrument table, and special equipment to be used in the sterile field are cleaned prior to each case. Imaging equipment, NARRATIVE 2-4 surgical microscopes, and other items that are difficult to clean are draped in sterilized plastic to maintain asepsis. The sterile field is showered by either a laminar flow array or a combination of laminar diffusers surrounded and encapsulated by an air curtain.

Note: The example shown is for a General OR, the sterile field supporting Complex OR procedures may be larger as there may be more procedural support equipment brought into the sterile field.

The anesthesiologist and nurse anesthetist remain outside of the sterile field and are typically separated from the sterile field by a sterile drape.

Maintaining Asepsis (Sterility) Regarding asepsis, the areas of concern (to minimize the number of pathogens present) within the Surgical and Interventional Suite are:

• The “sterile field” itself as described above. Only fully scrubbed staff (known as the “scrub team”) is permitted in this area in the center of

NARRATIVE 2-5

each Operating and/or Endovascular Procedure Room.

• Within the Operating and/or Endovascular Procedure Room, both the scrub team as well as the additional staff that are not in the sterile field must abide by strict rules established by the Medical Center.

Semi-restricted areas, including spaces such as the pre-operative and patient holding areas, PACU, instrument workroom, non-sterile supply storage, staff lockers/lounges/toilets/showers, control desk, and surgery administration offices.

Internal Operating Room Circulation It is critical to plan an Operating Room in such a way that a high level of sterile technique can be achieved.

The circulating nurse typically addressed as “the circulator” places the packs on the instrument table from the side of the instrument table away from the sterile field. The scrub nurse removes the sterile instruments and places them on the surgical instrument table prior to the procedure. Consideration should be given that with some specialty surgical procedures, the surgical instrument table is positioned toward the foot of the operating table, but always within the sterile field. A single instrument table may be up to 8.0 feet (2440 mm) in length, or there could be more than one instrument table. Once the procedure starts, the scrub nurse constantly draws from this source to supply the surgeons during the operation. The circulator also assists the surgeon with devices used in the sterile field such as lasers.

No one walks between the operating room table and the surgical instrument table, except those in sterile garb who have thoroughly scrubbed. When portable imaging equipment is used, space for these items must be considered. Surgical microscopes or video monitors on carts and other large pieces of equipment (including robotics) may also be needed in an Operating Room, and space for them must be considered.

The Surgical Team in a teaching VAMC is typically comprised of the following members:

Surgeon: The surgeon is a Medical Doctor who is board certified as a Surgeon and acts as surgical team leader to direct and supervise all aspects of a surgery. The responsible surgeon’s eligibility to perform a surgical procedure is based upon that surgeon’s education, training, experience, and demonstrated proficiency. Surgeons are expected to study and evaluate new procedures and to become knowledgeable of and proficient with advances that are appropriate. Technical skill alone is not sufficient to qualify a surgeon to perform new procedures. Procedural skills should be acquired within the context of in-depth knowledge about the disease to be treated. Qualification of a surgeon as a specialist carries the commitment and responsibility to conduct a surgical practice that conforms to his/her defined specialty. The appropriate surgical specialty board recognized by the American Board of

NARRATIVE 2-6

Medical Specialties (ABMS) or the Royal College of Physicians and Surgeons of Canada (RCPSC) determines a surgeon’s scope of practice.

Assistant Surgeon: A Medical Doctor who acts as assistant surgeon and may be one of the following medical professionals:

• Another surgeon

• A licensed physician assistant

• A registered nurse first assistant

• A surgical resident

• A medical student

“Assistant-in-Surgery”: Clinical professionals such as nurses, operating room technicians, or other specially trained professionals, whose services are included in the primary surgeon’s. The surgical assistant provides intraoperative functions that help the surgeon carry out a safe operation, such as exposure, hemostasis, and closure. In addition to intraoperative duties, the surgical assistant also performs preoperative and postoperative duties to better facilitate proper patient care, such as positioning of the patient, catheter placement, dressings, and patient transfer. The surgical assistant who has appropriate training also performs under surgeon supervision other procedures including but not limited to: vein and graft harvesting, and graft and implant preparation.

Second Assisting Technologist: The second assisting surgical technologist assists the surgeon and/or surgical assistant during the operative procedure by carrying out technical tasks other than cutting, clamping, and suturing of tissue. This role is distinct from that of the first assistant and may, in some circumstances, be performed at the same time as the scrub role.

Anesthesia Staff: Anesthesia is administered by the anesthesia staff, which can include anesthesiologists, anesthesia assistants, anesthesia residents, anesthesia technicians, and certified registered nurse anesthetists (CRNAs).

One or more anesthesia staff may be assigned to each Operating Room. It is the responsibility of the anesthesia staff to consult with the patient before surgery and identify family/friends that will speak to the surgeon after the procedure, to administer the anesthetic agent before and during surgery, and to monitor the patient’s vital signs. Anesthesia staff remain with the patient during the entire surgical procedure. Following the surgery, the patient remains under the care of the anesthesia staff and the assigned recovery room nurse until the patient has met the discharge criteria.

Interventional Radiologist: A trained physician who specializes in minimally invasive treatments across all specialties. The interventionalist utilizes imaging equipment to advance catheters into the patient’s artery and/or vein to treat the source of disease internally (known as a closed procedure). In an interventional case there may be a team of interventional staff consisting

NARRATIVE 2-7

of the interventional radiologist, a radiology circulating nurse and a radiology scrub person.

Interventional Cardiologist: An interventional cardiologist is a specialized interventional radiologist who specializes in treating a range of heart and vascular conditions through a process called catheterization. Additionally, the Interventional Cardiologist preforms transaortic valve replacement (TAVR) and mitral valve replacement in a specialized operating room known as a hybrid OR.

Electrophysiologist: An Electrophysiologist is a cardiologist who treats heart arrhythmias and other heart rhythm disorders. These can include irregular heartbeats, including instances where the heart beats too quickly (tachycardia), and when the heart beats too slowly (bradycardia).

Electrophysiologists are dedicated to the study of the heart’s electrical system, and how to diagnose and treat heart arrhythmias.

Vascular Surgeon: A vascular surgeon is a surgical subspecialty that focuses on diseases of the vascular system, or arteries, veins and lymphatic circulation, are managed by open surgery or closed minimally-invasive catheter procedures, including surgical reconstruction. This specialty evolved from general and cardiac surgery as well as minimally invasive techniques pioneered by interventional radiologists.

Nursing and Clinical Support Staff:

Every major surgical procedure performed in the Operating Room is staffed by at least one registered nurse and scrub personnel.

• Surgical Scrub: The surgical scrub, together with the first assistant to the surgeon, is the main support person for the operating surgeon. He/she has an understanding of the procedure being performed and anticipates the needs of the surgeon. The scrub personnel are responsible for the sterile supplies and instruments and for handing them to the surgeon. He/she has the necessary knowledge and ability to ensure quality patient care during the operative procedure and is constantly on vigil for maintenance of the sterile field. More complicated surgical procedures may require the presence of two scrub personnel, one assisting the surgeon at the operating room table and one responsible for the instruments at the instrument table.

• Circulating Nurse: The circulating nurse, known as the circulator, does not function within the sterile field, but performs many of the required tasks outside the sterile field. This person also acts as the “non-sterile” hands of the surgeons and scrub person, bringing required supplies, instruments and equipment into the Operating Room, maintaining surgical records in the Operating Room, etc. Although the surgeon performing the operation has the ultimate responsibility for the care of the patient in the Operating

NARRATIVE 2-8

Room, it is the circulator who is responsible for maintenance of sterile conditions and is in charge of personnel. This person is the primary advocate ensuring that correct surgery is performed by confirming proper patient identification and surgical site(s), confirming that a history and physical is on the patient chart, and confirming that a signed surgical consent is present. The circulator also enters safety measures into the computer, records time out, and assures that the proper prosthetics, if required, are available.

• Surgical Technologist: Surgical Technologists and/or Nursing Assistant:

This individual has received special training in sterile technique and in assisting in the Operating Room. If appropriately trained, this individual may perform the same duties as a scrub person.

• Perfusionist: A perfusionist is a specialized healthcare professional who uses the heart-lung machine during cardiac surgery and other surgeries that require cardiopulmonary bypass to manage the patient’s physiological status. In cardiovascular surgery, the patient’s blood may have to bypass the heart to allow the surgeon to perform the required surgical procedure. The blood supply bypasses the heart and circulates through a heart-lung machine (which is both a mechanical pump and artificial lung) after which it is returned to the patient as oxygenated and purified blood. The perfusionist, who oversees this process, works in the Operating Room, usually at the side of the operating table, but well outside the sterile field area. The heart/lung machine must be connected to both a water supply and the electrical supply. Two perfusionists may be required for each cardiovascular operation, in the event that a cell-saver (auto-transfusion) device is used.

• Charge Nurse: The charge nurse supervises all activities that occur within the individual Operating Rooms. The charge nurse is also available to temporarily replace the scrub nurse during long operations. The office of the charge nurse may be located within the clean core.

• Nurse Manager: The nurse manager (also known as the perioperative nurse manager) is the administrative supervisor of the entire Operating Room Suite. The nurse manager is responsible for maintaining the scheduling of patients for operations, as well as purchasing and maintaining supplies and equipment for use in the Operating Room Suite.

The office of the nurse manager is located inside the Surgical Suite.

• Surgical Pathologist: The surgical pathologist does not function within the clean core area or within the individual Operating Rooms, though accessed from the semi-restricted corridor. Tissue specimens removed from a patient are sent to the surgical pathologist, who prepares and examines the tissue in a frozen section laboratory within the surgical

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suite. The pathologist then electronically communicates his/her findings to the surgeon.

• Consultant: Should the operating surgeon desire a consultation for a patient under anesthesia or during the operation, he/she may request that a consultant come to the Operating Room to examine the patient. In most instances, the individual consulted is an internist or cardiologist. This individual usually does not work within the sterile field but examines the physiologic data regarding the patient and presents his advice regarding additional appropriate treatment.

• EEG Technician: The EEG Technician is an individual who operates the electroencephalograph in the Neurosurgery Operating Room to record the brain waves of the patient. Usually this monitoring is required only in patients undergoing brain surgery. This individual operates the EEG machine outside of the sterile field.

• Imaging Technician: The imaging technician is in charge of taking digital images when needed within the Surgical Suite. The images are digital and can be viewed on monitors mounted on booms in the sterile field as well as large wall-mounted monitors.

• Patient Transport Staff: The patient transport staff is responsible for transporting patients to the Surgical Suite from other parts of the hospital.

When a patient is very heavy, the patient transport staff might assist in transferring the patient from the transporting gurney to the operating room table. The patient transport staff also helps in moving equipment in and out of the Operating Room before the patient is brought into the room.

• Visitors / Technical Support: In most hospitals affiliated with a Medical School, visitors may be invited into the Operating Room to view a specific type of operative procedure. Technical support personnel may be invited into the Operating Room to consult on the use of specialized equipment.

In all cases, the patient must have given prior consent to the presence of these non-surgical staff in order to maintain patient privacy and follow HIPAA regulations. These individuals must be appropriately attired. They also wear head covering and shoe covers, but not necessary gloves, since they do not work within the sterile field. It is the circulator’s responsibility to monitor the visitors and technical support personnel activities.

• Biomedical Equipment Support Specialist: The Biomedical Equipment Support Specialist utilizes extensive knowledge in the safe and effective application of healthcare technology and serves as a senior level healthcare technology specialist in the Surgical Suite. They provide support of the devices/systems utilized during procedures and analyze/ remediate any performance deficiencies.

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• Housekeeping Staff (Operating and Endovascular Procedure Rooms):

Specially trained housekeeping staff is assigned to decontaminate and sterilize the Operating Rooms and equipment after each procedure. They work out of a dedicated housekeeping closet accessed from the semi-restricted corridor. A dedicated housekeeping closet is required in the semi-restricted area, which will support cleaning of all of the operating rooms, the Clean Core, as well as the balance of the semi-restricted area.

Space Planning and Design The following is an overview of basic planning criteria, which are desirable as standards for Surgical OR’s and Endovascular Procedure Rooms. For further detailed information, refer to VA Technical Information Library (TIL), Space Planning Criteria for VA Facilities SEPS (PG 18-9) https://www.cfm.

va.gov/til/space/spChapter286.pdf.

Size of Operating Rooms: While the minimum size of operating rooms is covered in this document, there are other dimensions, such as width and depth of the room shall be at least 20’-0” (6,096 mm), ceiling height and plenum space above, must be taken into consideration in the design of an operating room and/or endovascular procedure room. In renovation projects there may not be sufficient space to accommodate new Operating Rooms due to size and existing space geometry. Written concurrence from the VA National Director of Surgical Surgery must be obtained before proceeding further in the design process for renovation projects. Recessed wall storage cabinets, if requested, should be in addition to the square footage required for each Operating Room and/or endovascular procedure room. These cabinets are typically used for storage of frequently used supplies only. When a substantial number of storage cabinets in each Operating Room is needed by local surgical staff, space in the clean core reserved for exchange carts with sterile supplies on them can be reduced.

Scrub Sink Area: The Scrub Sink Area is an alcove located in the semi-restricted area at or between entrances to a single surgical operating room or between the entrances at two adjacent surgical operating rooms and/or endovascular procedure rooms. It is acceptable for one Scrub Sink Area to be shared between two Operating Rooms; however, when Operating Rooms are laid out in a same-handed arrangement, it is advisable to provide a separate scrub sink alcove for each OR and/or Endovascular Procedure Room.

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Triple scrub sink configuration shown, vision lights into surgical OR are optional.

The scrub alcove above is stocked with a variety of types and sizes of sterile gloves, sterile gown packs, antimicrobial cleansing solutions and sterile nail brushes/ sponges with a nail pick. These brushes are pre-packed, for single use only and some may already be impregnated with an antimicrobial solution. Scrub brushes may be placed in dispensers next to sinks.

Sinks are provided with hot and cold water and tap controls must be adjusted for water temperature flow before starting to scrub. Running water is preferred because it easily rinses away suds containing bacteria. Containers for antimicrobial solutions are placed between each set of taps and care should be taken not to contaminate hands when dispensing solution. The pump dispenser must be changed each time an empty bottle is replaced with a new one. The standard solutions such as Povidone Iodine or Chlorhexidine (triclosan), or acceptable equivalent may be available for those practitioners who are sensitive to the standard solutions.

Surrounding finish surfaces of scrub sink alcove area surrounds shall be waterproof (consider hard surfacing) as spray water is common when washing hands and arms as part of the scrubbing in process.

Gurney Storage: Surgical patients are brought into the Operating Room on a gurney or on a combination gurney/recovery room bed. In some cases, such as ophthalmic surgery, a recovery bed or gurney is used instead of a standard operating table for the procedure. Normally, the patient is transferred to the operating table in the room and the gurney is removed from the OR.

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An alcove is provided directly outside the Operating Room in the semi-restricted corridor where the vehicle is parked during the procedure. After surgery the patient is placed back on the gurney and moved to the Recovery Patient Area. The patient may be transferred to a hospital bed at this point.

There are occasions when a patient is transferred directly from the Operating Room onto a hospital bed and taken directly to the Surgical Intensive Care Unit (SICU). The gurney alcove outside each OR should be large enough to accommodate a standard hospital bed in its maximum configuration with IV poles, etc. attached. For this reason, the alcove should measure 4 ft. (1200

mm) wide by 10 ft. (3040 mm) long.

Imaging Equipment: The use of portable radiographic and fluoroscopic (R&F) imaging devices in the operating room is well established and is commonly associated with orthopedic procedures. These devices typically have low emission rates and appropriate evaluation of gross anatomic structures and dense objects such as orthopedic transplants. Low emission cannot achieve image quality requirements associated with the visualization of fine vascular details and stent placement. The expanded role of R&F imaging for vascular indications was made possible through C-arms capable of delivering much higher x-ray. However, their use predicated that they be fixed / dedicated to the procedure room as access to higher input power was required to produce higher x-ray, including radiation protection of the procedure room which is not required for portable low emission devices.

Dedicated C-arms initially became popular in the interventional cardiac and interventional radiology arenas as a diagnostic tool to assess flow restricting disease, map the electrical pathway of the heart, and to provide image guidance for the execution of interventions. These early procedure rooms were known as “Cath Labs” and did not possess the attributes of an operating room (OR) environment; laminar flow, higher level sterile practices, and the ability to support open surgery.

More recently, through the growth of minimally invasive surgery on patients with risks requiring a surgical safety net including endograft placement, and the inception of valve replacements, a specialized interventional / surgical environment was established. The result was the cardiovascular hybrid operating room.

When imaging equipment is used (fixed or mobile) in a traditional operating room and/or hybrid operating room, staff are required to wear lead aprons and work from behind leaded glass shields. When not in use in the operating rooms, portable imaging equipment is usually stored in alcoves in the semi-restricted corridor so it can be efficiently moved in and out of the operating room. The level of use of mobile imaging equipment and other factors will be analyzed by the physicist, who will determine the need for fixed shielding in the room.

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Sterile Supplies: Sterile supplies are typically retrieved from the clean core by the circulator. A selection of sterile supplies may also be stored within the Operating Room.

Supplies may be bar-coded or may utilize radio-frequency identification (RFID) chips. Both systems are designed to monitor use of supplies and to allow computerized reorder to maintain the appropriate inventory. In addition, scanning the bar code (or tracking supplies with RFID chips) provides a more complete system for charging for supplies used during a surgical procedure.

It also expedites the removal of stored items in the Operating Room when their shelf life has expired.

Case Carts: Case carts are used to bring sterile materials and instruments from SPS to the Operating Room. A typical case cart contains specific items required for each specific case, including all required surgical instruments and other supplies. It is advisable for the planner to confer with nursing staff as to the size of their case carts as each hospital is different. Note that more complex procedures may require several case carts. Clean case carts are typically staged in the Clean Core outside of the Operating Room prior to a procedure to optimize turnover time. Some case carts may remain in the Operating Room during the procedure and be used as back tables. After the surgical procedure is completed, these case carts are returned via the semi-restricted corridor to the “soiled” side of SPS on another dedicated soiled cart lift room or dedicated soiled elevator. In the event that SPS is not located below the Surgical Suite, an alternative traffic pattern for the case carts must be established that isolates clean and soiled case cart traffic.

Dedicated elevators are to be sized to accommodate a set number of case carts in the elevator cab.

Pre-Operative Holding / Phase II Recovery: The inpatient or outpatient is brought into the Pre-Operative Holding Area prior to the surgical procedure.

Last minute consultations with the patient by the staff take place here. Shunts for IV solutions may be inserted here. To comply with HIPAA requirements, patient areas must provide acoustical and visual privacy at all times.

The Phase II Recovery Patient Area is utilized for recovery of the patient after Phase I Recovery (PACU) and also for ambulatory surgery patients who may come directly from the surgical OR if they have been anesthetized under mild MAC sedation where recovery is fairly quick. The Prep Area should be co-located with the Phase II Recovery Room to provide maximum flexibility for the patient room assignment. Since most surgical procedures start in the morning, the Prep Area can occupy under-utilized Phase II Recovery Space in the morning however, the same area can be utilized for Phase II recovery in the afternoon.

Phase I (PACU) Recovery: During Phase I care, the focus is on the patient’s recovery from anesthesia and the return to baseline vital signs. Consideration

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is given to the procedure, anesthesia care, patient comorbidities, and the patient’s physical status to recognize, minimize and manage any issues or complications. Phase I includes, but is not limited to, applying PACU scoring criteria on admission and each vital signs assessment, managing respiratory and hemodynamic changes, monitoring the effects of the procedure (e.g., bleeding, circulation), and providing necessary analgesia and antiemetics.

While monitoring requirements are facility-specific, they are also based on the patient’s condition. According to ASPAN, they recommend assessing and documenting vital signs at least every 15 minutes during the first hour and then every 30 minutes until discharge from Phase I PACU care. After which, the patient is then transitioned to Phase II, the inpatient setting, or the intensive care unit (ICU) for continued care.

Patient Induction / Preparation Room: For most procedures, anesthesia is given in the induction room located next to the operating room. In many cases induction may be performed in the pre-operative Phase I area. “Induction” is the start of anesthesia and usually takes less than five (5) minutes to perform. The patient induction room is used by the anesthesiologist to initiate anesthesia and to observe the patient prior to the start of a procedure. It allows for parallel processing of the patient and the Operating Room. Typical tasks in this area include nerve blocks and the placement of intravenous (IV) lines. From here the patient is transferred to the Operating Room.

Operating Room Types:

There are several types of operating rooms depending on the type of surgery being performed. i.e. General, Orthopedic, Neuro, Spine, Urology, Transplant. Cardiac/Thoracic and special operating rooms such as Hybrid OR’s.

The reason for having different types of operating rooms is that different procedures require different equipment and personnel. The staff must have access and enough room to move and navigate the equipment required for each type of surgery.

1. General Operating Room: General surgery operating room is where surgeons focus typically on numerous abdominal contents including esophagus, stomach, small intestine, large intestine, liver, pancreas, gallbladder, appendix, bile ducts, and often the thyroid gland (depending on local referral patterns).