SOW Attachment 02 - PG 18-12 Pharmacy Service.pdf

Pharmacy Service

April 1, 2018 rev. July 1, 2022

PG 18-12 – PHARMACY SERVICE DESIGN GUIDE APRIL 1, 2018

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TABLE OF CONTENTS

1.0 GENERAL 1-1

1.1 Foreword 1-3

1.2 Acknowledgments 1-5

1.3 Introduction 1-9

1.4 VA Policies / Standards and Industry Policies / Standards 1-11

1.4.1 VA Policies/Standards 1-11

1.4.2 Industry Codes/ Standards 1-12

1.4.3 HIPAA 1-12

1.4.4 Disaster Planning 1-12

1.5 Abbreviations 1-13

1.6 Definitions 1-17

2.0 NARRATIVE 2-1

2.1 Clinical and Operational Summary 2-3

2.1.1 Pharmacy Staff and Role Descriptions: 2-3

2.1.2 Pharmacy Educational Program 2-5

2.1.3 Inpatient Pharmacy 2-6

2.1.4 Primary Inpatient Pharmacy Spaces and Functions 2-7

2.1.5 Outpatient Pharmacy 2-9

2.1.6 Primary Outpatient Pharmacy Spaces and Functions 2-10

2.1.7 Satellite Pharmacy 2-11

2.1.8 Waste Management 2-11

2.2 Trends in Pharmacy 2-13

2.2.1 Research Based Design 2-13

2.2.2 Technology Advancements: 2-13

2.2.3 Codes and Standards 2-14

2.2.4 Meds to Beds 2-14

2.2.5 Storage 2-15

2.2.6 Consolidated Mail Outpatient Pharmacy (CMOP) 2-15

2.2.7 Personalized Healthcare: DNA Driven Drug Development 2-16

2.3 Technical Considerations 2-17

2.3.1 VA Policies, Directives, Handbooks and Standards 2-17

• Local/State Codes and References 2-17

• Other Recommended Reference Standards 2-17

2.3.2 Architecture 2-18

• Ceilings 2-18

• Floors 2-18

• Walls 2-18

• Casework 2-19

• Countertops 2-19

• Acoustics / Noise Control 2-19

• Doors 2-19

2.3.3 Interior Design 2-20

• Interior Finishes 2-20

• Wayfinding 2-21

2.3.4 Heating, Ventilation, and Air Conditioning Systems 2-21

• Life Cycle Analysis 2-21

• Energy Conservation 2-22

2.3.5 Pneumatic Tube System 2-24

2.3.6 Plumbing Systems 2-24

2.3.7 Electrical Systems 2-25

2.3.8 Telecommunication, Monitoring, and Signaling Systems 2-26

2.3.9 Fire Protection and Life Safety 2-26

3.0 FUNCTIONAL CONCEPTS 3-1

3.1 General 3-3

3.2 Adjacency Diagrams 3-4

3.2.1 Bubble Diagram - Inpatient Pharmacy (IP) 3-4

3.2.2 Mockup Diagram - Inpatient Pharmacy (IP) 3-5

3.2.3 Bubble Diagram - Outpatient Pharmacy (OP) 3-6

3.2.4 Mockup Diagram - Outpatient Pharmacy (OP) 3-7

3.2.5 Mockup Diagram - Combined IP/OP Pharmacy 3-9

3.3 Medication Flow Diagrams 3-10

3.3.1 Inpatient Pharmacy (IP) 3-10

3.3.2 Combined Pharmacy IP Flow 3-11

3.3.3 Hazardous Drug (HD) Receiving/Storage 3-12

3.3.4 Sterile Compounding Flow 3-13

3.3.5 Outpatient Pharmacy (OP) 3-14

3.3.6 Combined Pharmacy: OP Flow 3-15

3.4 Security Diagram - Combined Pharmacy 3-16

3.5 Prototype - Combined Pharmacy 3-17

3.5.1 Prototype Floor Plan 3-17

3.5.2 Prototype Reflected Ceiling Plan 3-18

4.0 DESIGN GUIDE PLATES 4-1

4.1 Introduction 4-3

4.2 Legend of Symbols 4-5

4.3 Room Templates 4-9

4.3.1 Dispense/Consult Window - (PHOW2) 4-10

4.3.2 Filling/Assembly Area, Outpatient (PHOF1) 4-20

4.3.3 Processing Area, Outpatient - (PHPA1) 4-32

4.3.4 Secured Dispensing / Storage, Outpatient (PHOS1) 4-40

4.3.5 Discharge Pharmacist (PHDP1) 4-50

4.3.6 Work Room, IDS (PHID1) 4-58

4.3.7 Filling/Assembly Area, Inpatient (PHIF1)` 4-70

4.3.8 Processing Area, Inpatient (PHPA1) 4-84

4.3.9 Secured Dispensing / Storage, Inpatient (PHIS1) 4-92

4.3.10 Repackaging Area (PHIR1) 4-102

4.3.11 Non-Sterile Compounding Area (PHNS1) 4-114

4.3.12 Receiving/Breakdown, Inpatient (PHRB1) 4-122

4.3.13 Anteroom, Sterile Compounding (PHAR1) 4-134

5.0 APPENDIX 5-3

5.1 Site Visits 5-5

5.1.1 Introduction 5-5

5.1.2 Jesse Brown VAMC, Chicago, Illinois 5-7

• Medical Center Overview 5-8

• Pharmacy Overview 5-9

• Outpatient Pharmacy Plan 5-12

• Inpatient Pharmacy Plan 5-14

5.1.3 Edward Hines Jr. VAMC CMOP, Hines, Illinois 5-16

• Overview 5-17

• CMOP Overview 5-18

5.1.4 University of Chicago Medical Center, Chicago, Illinois 5-20

• Overview 5-21

• Pharmacy Overview 5-23

• Inpatient Pharmacy Plan 5-24

• Outpatient Pharmacy Plan 5-26

5.1.5 Elmhurst Memorial Hospital, Elmhurst, Illinois 5-28

• Overview 5-29

• Model of Care 5-32

• Pharmacy Overview 5-32

• Pharmacy Plan 5-34

5.1.6 Rush University Medical Center 5-38

• Overview 5-39

• Pharmacy Overview 5-40

• Pharmacy Plan 5-42

5.1.7 Orlando VAMC, Orlando, Florida 5-44

• Overview 5-45

• Pharmacy Overview 5-46

• Outpatient Pharmacy Plan 5-50

• Inpatient Pharmacy Plan 5-52

5.1.8 James Haley VAMC, Tampa, Florida 5-56

• Overview 5-57

• Pharmacy Overview 5-58

• Outpatient Pharmacy Plan 5-62

• Inpatient Pharmacy Plan 5-66

5.1.9 Malcom Randall VAMC, Gainesville, Florida 5-68

• Overview 5-69

• Pharmacy Overview 5-70

• Outpatient Pharmacy Plan 5-74

• Inpatient Pharmacy Plan 5-76

5.1.10 Washington DC VAMC, Washington, DC 5-78

• Overview 5-79

• Outpatient Pharmacy Patient Flow 5-82

• Pharmacy Receiving Distribution Flow 5-83

• Outpatient Pharmacy Sterile Compounding Flow 5-84

• Inpatient Pharmacy Medication Flow 5-85

• Outpatient Pharmacy Medication Flow 5-86

5.2 Storage Study 5-87

5.2.1 Jesse Brown VAMC Storage Survey 5-88

5.2.2 Orlando VAMC Storage Survey 5-89

5.2.3 Orlando VAMC Storage Survey 5-90

5.2.4 Tampa VAMC Storage Survey 5-91

5.2.5 Gainesville VAMC Storage Survey 5-92

5.2.6 UCMC Storage Survey 5-93

5.2.7 UCMC Storage Survey 5-94

5.2.8 Elmhurst VAMC Storage Survey 5-95

5.2.9 Rush VAMC Storage Survey 5-96

5.2.10 Washington DC VAMC Storage Survey 5-97

5.3 Test Fits 5-99

5.3.1 Consult Room 5-100

5.3.2 Phonebank, Telepharmacy 5-101

5.3.3 Storage, Prosthetics and Supplies 5-102

5.3.4 Filling/Assembly, Shelving Storage 5-103

5.3.5 Work Area, Sterile Compounding 5-104

5.3.6 Storage, Sterile Compounding 5-105

5.3.7 Workstation, Clinical Pharmacy Teaching Coordinator 5-106

5.3.8 Workstation, Intern/Student 5-107

5.3.9 Workroom, Resident 5-108

5.3.10 Pharmacy Cache 5-109

1.0 GENERAL

TABLE OF CONTENTS

1.1 Foreword 1-3

1.2 Acknowledgments 1-5

1.3 Introduction 1-9

1.4 VA Policies / Standards and Industry Policies / Standards 1-11

• 1.4.1 VA Policies/Standards 1-11

• 1.4.2 Industry Codes/ Standards 1-12

• 1.4.3 HIPAA 1-12

• 1.4.4 Disaster Planning 1-12

1.5 Abbreviations 1-13

1.6 Definitions 1-17

1.1 Foreword

VA Program Offices, project teams, designers and constructors, are obligated to our Nation’s Veterans and taxpayers to make the most effective and efficient use of resources, by providing a continuum of safe, secure, high quality, high performance, and high value environments of care and service for Veterans. The VA Office of Construction and Facilities Management (CFM) supports the Department’s mission through development and application of standards as a basis for disciplined planning, design, an d construction of VA facilities.

VA Standards are the culmination of a partnership among the Department of Veterans Affairs (VA), the Veterans Health Administration, Program Officials, Clinicians, Industry, Academic and Research Organizations, Expert Consultants, and the Office of Construction and Facilities Management. Design Guides are developed through integration of VA-specific requirements, Federal law and regulation, benchmarking of industry best practice, evidence-based research and design, and value-based analysis of leading edge innovation. The result is the establishment of best value standards for optimum functionality, safety, operability, performance, and quality throughout the VA environment of care and service.

Design Guides (PG-18-12) are a critical component of the VA Technical Information Library (TIL) (www.cfm.va.gov/TIL) which provides standards for all VA planning, design, and construction projects. Design Guides focus on selected healthcare departments and services and include an overview narrative of VA-specific planning and design principles and concepts, room templates, equipment lists, and basic technical/ engineering requirements. They communicate the basis of design and are required to be utilized by project teams working on new construction and renovations of existing facilities. Design Guides will maximize the effectiveness and efficiency of the planning and design process and ensure a high level of design, while controlling construction, operating, and maintenance costs.

www.cfm.va.gov/TIL

PG 18-12 – PHARMACY SERVICE DESIGN GUIDE

The material contained in Design Guides constitutes a Standard for VA Planning, Design and Construction. For all VA projects, it is required that project teams comply with the following in all phases of project development:

1. All applicable VA Standards published in the VA Technical Information Library (TIL) shall be applied as a basis, foundation, and framework in planning, design, and construction. Any substantial variance from Standards shall be considered only as required to accommodate specific site, functional, and operational conditions. Upon consideration of variance CFM shall be consulted, and each Administration will function as Authority Having Jurisdiction for decision. Each substantial variance shall have a basis rationale and be documented in the project record

2. Clinicians, providers, primary users, and other stakeholders shall be involved in all phases of project development to best adapt Standards for specific functional, operational, and site conditions, and to provide optimum service environments for Veterans.

This also includes installations and modifications of systems or technology involving safety, security, functionality, or environmental quality. Stakeholder involvement shall be documented in the project record

Design Guides are not project-specific. It is impossible to foresee all rapidly evolving requirements of healthcare facilities and each site or project will have unique requirements or conditions. Site-specific issues must be addressed within the context of these standards and applied to each individual project. Use of this Guide does not preclude the need for, nor absolve planners, designers, and constructors of their responsibility to provide complete, functional, safe, and secure designs suited to the unique requirements of each project, within budget, and on schedule.

Materials, equipment and systems are shown in an illustrative, performance-based format and are not intended to depict, suggest, or otherwise constitute endorsement of any specific product or manufacturer.

Manufacturers should be consulted for actual dimensions, configurations, and utility requirements.

All participants in the project development process must embrace VA Planning, Design and Construction Standards as fundamental in providing optimum environments for Veterans’ care and services, in fulfilling VA’s mission.

APRIL 1, 2018

1.2 Acknowledgments

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

VETERANS HEALTH ADMINISTRATION (VHA)

PHARMACY SERVICE (FIELD BASED)

Keri Justice Malcolm Randall VAMC

Heather Taxeras, Pharm.D Malcolm Randall VAMC

Rachel Cornett, Pharm.D Malcolm Randall VAMC

Richard Rooney, Pharm.D Jesse Brown VAMC

Isabel Sanvanson Karceski, Pharm.D Jesse Brown VAMC

Ivan Itebejac, Pharm.D, Orlando VAMC

Jacqueline Kill, Pharm.D Orlando VAMC

Kyle Hagen, Pharm.D Orlando VAMC

Alicia Decker, Pharm.D Orlando VAMC

Peter Willis, Pharm.D Orlando VAMC

Kim Mowrey, Pharm.D James A Haley VA Hospital

Freddy Tadros James A Haley VA Hospital

Chief, Pharmacy Service

Inpatient Pharmacy Supervisor

Outpatient Pharmacy Supervisor

Chief, Pharmacy Service

Associate Chief of Operations

Chief, Pharmacy Service

Associate Chief of Pharmacy

Inpatient Pharmacy Supervisor

Outpatient Pharmacy Supervisor

Outpatient Pharmacy Supervisor

Chief, Pharmacy Service

Associate Chief of Pharmacy

PHARMACY BENEFITS MANAGEMENT SERVICE (PBMS)

Vaiyapuri Subramaniam, Pharm.D Pharmaceutical Compounding & Management

Kimberly Quicci-Roberts

Philip Coggins Richmond VAMC

Steven Clause Tennessee Valley Health System

Roy Coakley

VISN 8

Louis Cobuzzi Planning Analysis & Development

Associate Chief Consultant

Health Science Specialist

Pharmacist

ACY Pharmacy Site Manager

Pharmacy Benefits Manager

Associate Chief Consultant

ENVIRONMENTAL PROGRAM SERVICE (EPS)

Christine Emanuelson Environmental Programs Service Program Manager, Interior Design

OFFICE OF CAPITAL ASSET MANAGEMENT ENGINEERING AND SERVICES

(OCAMES)

Brandilyne Stockstill Capital Support Engineer

Brian Melewski Capital Support Engineer

OFFICE OF OPERATIONS, SECURITY AND RESILIENCE (OSR)

Forrest Frakes Senior Telecommunications Office of Operations, Security & Resilience Specialist

OFFICE OF CONSTRUCTION & FACILITIES MANAGEMENT (CFM)

Don Myers, Director

Gary Fischer, AIA Facilities Standards Service

Orest Burdiak Facilities Standards Service

Jacob Brown Facilities Standards Service

Mahmut Nazli Facilities Standards Service

David Tash Facilities Standards Service

Michael Taylor Facilities Standards Service

Lam Vu Facilities Standards Service

Mark Wiersma Consulting Support Services

Michael Koch Consulting Support Services

David Treece Consulting Support Services

Linda Chan Facilities Planning Development Service

Facilities Standards Service

Senior Healthcare Architect

Principal Interior Designer

Medical Equipment Specialist

Mechanical Engineer

Mechanical Engineer

Plumbing Engineer

Electrical Engineer

Director

Architect

Senior Healthcare Architect

Planner/Architect

CONSULTANTS - SMITHGROUPJJR

Bill Kline, AIA, ACHA, EDAC, LEED AP Principal in Charge

Naomi Kruger, IIDA, LEED AP BD+C Project Manager

Joshua Hendershot, AIA, NCARB EDAC, LEED AP Senior Medical Planner

Stephen Parker, AIA, NCARB LEED AP BD+C Architect

Laura Babinski, RA, LEED AP BD+C Architect

SUB-CONSULTANTS - THE INNOVA GROUP

Chris Phillips Project Manager

Eric Hunt Equipment Planner

Lee Pettit, AIA, LEED GA Space Planner

SUB-CONSULTANTS - URS CORPORATION

Troy Metz, PE Mechanical Department Manager

William Hoffman, PE Mechanical Engineer

Danny Reyno Electrical Engineer

1.3 Introduction

This Pharmacy Service Design Guide (PG-18-12) replaces the first Design Guide for Pharmacy Service which dates from 1995. One of the primary drivers for developing this update to the Design Guide is due to the age of the current information available within VA for use on facility design and construction projects, with the knowledge that there have been significant changes to Pharmacy Service over this period of time.

The Office of Construction & Facilities Management worked with the Pharmacy Benefits Management Service and Pharmacy Service field based personnel on this effort to establish a new ‘Best Practice’ standard for VA facilities providing pharmacy services to the nations Veterans. This effort involved site visits, research, information development and testing of related information used in the formulation of space projections for potential new facility projects.

The Design Guide represents planning and design standards that have been developed to support the delivery of patient care for Pharmacy Service. These standards apply to Inpatient Pharmacy and Outpatient Pharmacy contained within a VA Medical Center (VAMC) as well as Outpatient Pharmacy in large Outpatient Clinics / Ambulatory Care Centers or in off-site locations from a VAMC. The Pharmacy Service contained in a CBOC setting (most often under 100,000 BGSF) are addressed in the PACT / Outpatient Clinic Space Planning Criteria Chapter and Design Guide.

The standards set forth herein are not intended to be project-specific, nor are they crafted as a regulatory code. The Design Guide addresses space and equipment planning, based on the functional, technical, and systems requirements to support the operational requirements associated with the various Pharmacy services. The narrative and graphic material developed in this document are based on the site visits of both recently built/ renovated and older facilities, staff interviews, collaborative work sessions and meetings, and research of relevant publications and standards.

The Design Guide, in conjunction with PG-18-9, Space Planning Criteria Chapter 268: Pharmacy Service and PG-18-5, Equipment Guide List – Pharmacy Service, is a design tool for VA Medical Center clinical and administrative staff, planners, architects, interior designers, engineers, and consulting architects and engineers (A/E’s) to assist with understanding the unique functional and technical requirements associated with this patient care service. The concepts and standards set forth in these documents address the space needs for Pharmacy Service when provided within a VA Medical Center environment and when provided within a VA Ambulatory Care or Outpatient Environment. In addition, within the context of the information contained in the Design Guide an approach is discussed on how to apply these standards to pharmacy projects planned to be renovated within an existing building.

1.4 VA Policies / Standards and Industry Policies / Standards

1.4.1 VA Policies/Standards

1. Master Construction Specifications PG-18-1

2. Design and Construction Procedures PG-18-3 (Refer to the PG-18-3

(Topic 1) for the list of Codes, Standards and Executive Orders.)

3. Standard Details PG-18-4

and MH RRTP that often require Pharmacy space:

◦ Chapter: Ambulatory Care (Hospital-Based)

◦ Chapter: Inpatient Nursing Units

◦ Chapter: Small House Model

◦ Chapter: CBOC Prototype Study

◦ Chapter: Surgical and Endovascular Services

◦ For VA Mission Critical Facilities

◦ For VA Life-Safety Protected Facilities

1.4.2

1.4.3

1.4.4

Industry Codes/ Standards

1. FGI Guidelines for Design and Construction of Hospital and Outpatient Facilities - Current Edition

2. United States Pharmacopeia Convention (USP) Compounding Compendium - Current Edition

HIPAA

The Healthcare Insurance Portability and Accountability Act of 1996 (HIPAA) protects individuals 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. These Design Standards recommend 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.

Refer to the Physical Security Design Manual For Va Life-Safety Protected Facilities, and Physical Security Design Manual for VA Mission Critical Facilities.

1.5

A

ABA

ABAAS

AC/HR

ACT

ADA

ADAAG

ADM

A/E

AFF

AHJ

AIA

ANSI

ASHRAE

AR

ASC

AT

AT (SP)

BC

BMS

C

CC

CFM

CFM

CMS

CON

CV

CLG

CO2

Abbreviations

Amps/Amperes

Architectural Barriers Act

Architectural Barriers Act Accessibility Standard

Air Changes per Hour

Acoustical Ceiling Tile

Americans with Disabilities Act

ADA Accessibility Guidelines

Automated Dispensing Machine

Architectural / Engineering Firm

Above Finished Floor

Authority Having Jurisdiction

American Institute of Architects

American National Standards Institute

American Society of Heating, Refrigerating & Air Conditioning Engineers

As Required

Ambulatory Surgery Center

Acoustical Ceiling Tile

Acoustical Ceiling Tile (with Sprayed Plastic Finish)

Base Cabinet

Building Management System

Degree Celsius

Contractor Furnished, Contractor Installed

Cubic Feet per Minute

Office of Construction & Facilities Management

Centers for Medicare and Medicaid Services

Certificate of Need

Control Valve

Ceiling

Carbon Dioxide

CP

CT

DG

DOE

DP

DS

EDM

EES

EMER

F

FC

FD

FIXT

FLUOR

FM

FMS

FPS

GFI

GSF

GSM

GWB

HAC

HD

HATCH

HIPAA

HVAC

HP

HR

IDS

IES

Carpet (without cushion broadloom)

Ceramic Tile

Design Guide

Department of Energy

Automatic Push Plate

Door Switch

Electrical Design Manual

Essential Electrical System

Emergency

Degrees Fahrenheit

Foot-candle

Floor Drain

Fixture

Fluorescent

Facilities Management

Facilities Management Service

Fire Protection System

Ground Fault Circuit Interrupter

Gross Square Feet

Gross Square Meters

Gypsum Wallboard

Housekeeping Aides Closet

High Density Storage / Hazardous Drugs

Holistic Approach to Transformational Change

Health Insurance Portability and Accountability Act of 1996

Heating, Ventilating and Air Conditioning

Horsepower

Hour

Investigational Drug Services

Illuminating Engineering Society

IESNA

IP

IPS

JSN

kW

LED

LEED

LB

LLTS

MATV

MCS

MID

MTD

NEC

NFPA

NSF

NSM

O

OBRA

OIT

OP

OSHA

PACU

PG

PH

PFD

PP

PSDM

PTS

RB

Illuminating Engineering Society of North America

Inpatient

Isolation Power System

Joint Schedule Number

Kilowatt

Light Emitting Diode

Leadership in Energy and Environmental Design

Pound/Pounds

Lockers, Lounges, Toilets & Showers

Master Antenna Television

Master Construction Specifications

Motion Intrusion Detection

Mounted

National Electrical Code

National Fire Protection Association

Net Square Feet

Net Square Meters

Oxygen

Omnibus Budget Reconciliation Act of 1987

Office of Information & Technology

Outpatient

Occupational Safety and Health Administration

Post Anesthesia Care Unit

Program Guide

Phase

Program for Design

Push Plates

Physical Security Design Manual

Pneumatic Tube Station

Resilient Base

V

RCP

RES

RF

RPS

RSF

SC

SD

SF

SOPC

SP

STC

TIL

UPS

USGBC

USP

VA

VACO

VAMC

VA-SEPS

VAV

VC

VHA

VISN

VOC

VSO

VTEL

VV

W

Reflected Ceiling Plan

Resinous Flooring

Rubber Flooring

Radio Paging System

Resilient Sheet Flooring

High Build Glazed Coating (Special Coating)

Standard Detail

Square Foot, Square Feet

Satellite Outpatient Clinic

Special Faced

Sound Transmission Class

Technical Information Library provided by the VA online @ http://www.cfm.

va.gov/TIL/

Uninterruptible Power Supply

United States Green Building Council

United States Pharmacopeia

Volts

Department of Veterans Affairs

Veterans Affairs Central Office

Veterans Affairs Medical Center

Space and Equipment Planning System (see definitions)

Variable Air Volume

VA Furnished, Contractor Installed

Veterans Health Administration

Veterans Integrated Health Network

Volatile Organic Compound

Veterans Service Organizations

Video Teleconferencing

VA Furnished, VA Installed

Watts

APRIL 1, 2018

http://www.cfm.va.gov/TIL/ http://www.cfm.va.gov/TIL/

1.6 Definitions

Clean Room

Doff

Don

Essential Electrical System (EES)

Gross Square Feet

(GSF)

Hazardous Drugs

High-efficiency particulate air (HEPA) filtration

Leadership in Energy and Environmental Design (LEEDTM)

Mechanical Area

National Fire Protection Association (NFPA)

A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class.

To remove PPE

To put on PPE

A system comprised of alternate sources of power, all connected distribution systems, and ancillary equipment, designed to ensure continuity of electrical power to designated areas and functions of a health care facility during disruption of normal power sources, and designed to minimize disruption within the internal wiring system.

Total building gross areas measured from exterior faces of exterior walls

Drugs are classified as hazardous if studies in animals or humans indicate that exposures to them have a potential for causing cancer, development or reproductive toxicity, or harm to organs

An extended-medium, dry-type filter in a rigid frame, having a mini-mum particle collection efficiency of 99.97% for particles with a mass median diameter of 0.3 mm

Includes a rating system for building design as well as professional accreditation for people working in the design building industry.

Main boiler room and other mechanical and electrical areas;

included in gross areas and excluded in net areas.

Produces a code used in many jurisdictions to define fire protection requirements of building codes. VA uses several of the NFPA codes including NFPA 101, Life Safety Code.

Negative Pressure A room that is at a lower pressure than the adjacent spaces and, Room therefore, the net flow of air is into the room

Net Area / Net Square Feet (NSF) / Net Square Meters

(NSM)

Pass-through

Personal protective equipment (PPE)

Positive Pressure Room

Repackaging

Spill kit

United States Green Building Council

(USGBC)

VA-SEPS

The area of rooms or spaces as measured from the inside wall to inside wall and assigned to functional use by occupants.

An enclosure with interlocking doors that is positioned between two spaces for the purpose of reducing particulate transfer while moving materials from one space to another. A pass-through serving negative-pressure rooms needs to be equipped with sealed doors

Items such as gloves, gowns, respirators, goggles, faceshields, and others that protect individual workers from hazardous physical or chemical exposures

A room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room

The act of removing a product from its original primary container and placing it into another primary container, usually of smaller size

A container of supplies, warning signage, and related materials used to contain the spill of an HD.

The United States Green Building Council is a national coalition of leaders in the building industry that developed the LEED™ system.

Acronym for Space and Equipment Planning System, a digital tool developed by the Department of Defense (DoD) and the Department of Veterans Affairs to generate a Program for Design (PFD) and an Equipment List for a VA healthcare project based on specific information entered in response to Input Data Statements. SEPS 3, the current version, incorporates the propositions set forth in all VA space planning criteria chapters. SEPS 3 is designed to aid healthcare planners in creating a Program for Design (PFD) and Program Room Contents (PRC) based on a standardized set of criteria parameters.

2.0 NARRATIVE

TABLE OF CONTENTS

2.1 Clinical and Operational Summary 2-3

• 2.1.1 Pharmacy Staff and Role Descriptions: 2-3

• 2.1.2 Pharmacy Educational Program 2-5

• 2.1.3 Inpatient Pharmacy 2-6

• 2.1.4 Primary Inpatient Pharmacy Spaces and Functions 2-7

• 2.1.5 Outpatient Pharmacy 2-9

• 2.2.5 Storage 2-15

2.3 Technical Considerations 2-17

• 2.3.1 VA Policies, Directives, Handbooks and Standards 2-17

• 2.3.2 Architecture 2-18

• 2.3.3 Interior Design 2-20

• 2.3.4 Heating, Ventilation, and Air Conditioning Systems 2-21

• 2.3.5 Pneumatic Tube System 2-24

• 2.3.6 Plumbing Systems 2-24

• 2.3.7 Electrical Systems 2-25

• 2.3.8 Telecommunication, Monitoring, and Signaling Systems 2-26

• 2.3.9 Fire Protection and Life Safety 2-26

2.1 Clinical and Operational Summary

The Pharmacy Department serves both inpatient and outpatient needs.

This includes, but is not limited to Inpatient Nursing Units, Small

House Model units, Surgical Services, Emergency Departments, Pain

Management and Ambulatory/Outpatient Care Clinics.

Although it is ideal for both inpatient and outpatient pharmacies to be combined, or in close adjacency, it is not always possible due to space constraints and facility needs. Some facilities operate with cross trained staff that are able to flex easily between the different work-flows and is recommended that a combined pharmacy be considered when possible.

2.1.1 Pharmacy Staff and Role Descriptions:

To help the design team better understand the roles of the staff and their level of interaction with the pharmacy, a brief description of the more common positions are listed below for reference. These roles are here for reference only and may vary per facility

Chief of Pharmacy: Full and final responsibility for technical, clinical, professional, and administrative activities of the Pharmacy department.

The Chief of Pharmacy Services is the uppermost position in the pharmacy organizational hierarchy. The Chief of Pharmacy services works collaboratively with mid-level managers and clinicians to direct pharmacy services in all areas (clinical, educational, administrative, professional, research, technological, financial), but assumes ultimate responsibility for decisions made and their outcomes.

Assistant Chief of Pharmacy: Coordinates daily management of pharmacy operations to align with facility philosophies, policies, procedures, goals and objectives. The Assistant Chief of Pharmacy plays an active role in pharmacy program management and ongoing monitoring and evaluation of pharmacy programs. He or she is also involved with administrative and educational activities as well as human resource management and medication safety and security. Also will assume responsibility of the director when the Chief Pharmacist is absent.

Administrative Officer: Personnel management/administration, budgeting and financial management, procurement and contracting, property management. Works with human resource and sets up HR documents.

Duties may perform contracting officer monitoring for pharmacy contracts. Assist the preparation of presentations and data gathering.

Program Support Assistant: Performs administrative work at the direction of the pharmacy management, such as preparing documents, spreadsheets, Memo’s, Budgeting and functions as directed. Scheduling and coordinating meetings, interviews, events and other similar activities.

Assisting with all aspects of administrative management, directory maintenance, logistics, equipment. Preparing business correspondence, agendas for service meetings. Answering phones and providing customer service.

Clinical Pharmacy Supervisor: Daily professional and administrative operation of the clinical pharmacy program and the professional guidance and development of professional pharmacy staff. Responsible for designing, developing, implementing, and assessing progressive and comprehensive clinical pharmacy services and education programs to promote continued advancement of clinical pharmacy services within the organization.

Informatics Pharmacist: Responsible for the operation of the computer database systems. Key functions include the management of pharmaceutical pricing, drug accountability, drug information, pharmacy benefits management, and management of the drug file. Activities are designed to improve medication use through appropriate utilization of available technology. The ADPAC pharmacist is involved in development and assessment of clinical order sets to promote safe and effective medication use. ADPAC pharmacists also continually assess and update pharmacy technology as appropriate.

Pharmacoeconomist: Responsible for pharmacoeconomic program development, implementation, monitoring, and reporting. Key functions include: pharmacy formulary management, medication conversions, drug utilization evaluation, economic and clinical medication therapy assessments, patient outcomes assessments, and medical education and information communication. Primarily, the responsibility of this role is to ensure an appropriate balance between financial and clinical stewardship with respect to medication therapy.

Procurement Technician: Procurement technicians must be able to perform all responsibilities of inpatient and outpatient pharmacy technicians. Primary responsibilities, however, include maintenance and adherence to drug and supply inventory system to ensure that inpatient and outpatient pharmacies can function adequately. Inventory management, contractual assessments, and financial stewardship with respect to medication and supply acquisition are key functions.

Procurement technicians are also responsible for ensuring supply chain integrity and for appropriate receipt, storage, and reverse distribution of medication inventory under the supervision of pharmacy administrators.

Research Pharmacist: Responsible for the receipt, custody, distribution, billing, and preparation of all records for all investigational drugs used in the facility and for serving as the Pharmacy representative in all research-related committees. The research pharmacist reviews study protocols prior to Research and Development Committee consideration and negotiates and establishes mechanisms to allow appropriate handling of investigational medications. Research pharmacists ensure compliance with facility and regulatory requirements in the handling of investigational medications.

Pharmacy Resident (PGY1): PGY1 Pharmacy residents comprise the introductory post-graduate training program. Residents are responsible for a variety of clinical, administrative, and research-related activities.

Residents rotate through a variety of pharmacist positions under the supervision of qualified preceptors. Completion of a PGY1 residency program should equip graduates to perform at a high level across the spectrum of pharmacist roles.

Pharmacy Resident (PGY2): PGY2 Pharmacy residents comprise the specialized post-graduate training program. PGY2 pharmacy residencies are designed to produce highly-qualified practitioners in a designated pharmacy specialty. Rotations of PGY2 pharmacy residents are tailored to a specific field of interest. Common PGY2 programs include: infectious disease, pharmacy administration, psychiatry, critical care, ambulatory care, oncology, transplant, and others. Responsibilities include a combination of clinical, administrative, and research-related activities.

2.1.2 Pharmacy Educational Program

Like most clinical modalities, VAMC’s pharmacies provide education and training for residents and students around the country and are affiliated with major medical, nursing and allied health professional schools and colleges. For this reason additional space is required to support the educational program and staff support areas to accommodate training requirements. The additional space and size needs must be taken into consideration when determining the size and number of support spaces for teaching and educating, i.e., conference rooms, offices, staff lounges, resident spaces, etc.

2.1.3 Inpatient Pharmacy

Figure 2.1 Jesse Brown VAMC Inpatient Pharmacy

The Inpatient Pharmacy is comprised of all functional areas required to receive, process, fill, store and distribute all manners of medications to the inpatient population on the hospital campus. Although the Inpatient Pharmacy is responsible for monitoring and stocking medication supplies via medication rooms, medication dispensing stations and satellite pharmacies, these spaces are not addressed in this pharmacy design guide and should be referred to the appropriate design guide those rooms support.

The Inpatient Pharmacy should be centralized to the hospital and connected to key departments through close adjacency or delivery systems; e.g., pneumatic tube system and/or robotics, and have close proximity to the loading dock area.

Security: The Inpatient Pharmacy is a staff only secured space and is typically detached from public access by design. Secured access is used to not only refuse public admittance, but also to allow only approved hospital staff members in appropriate areas. The wall construction around the Pharmacy is of a non scalable construction, meaning the partitions will run to the underside of the floor or roof deck above. See the VA Architectural and the Physical Security Design Manual for VA Mission Critical Facilities for design requirements.

2.1.4 Primary Inpatient Pharmacy Spaces and Functions

Filling / Assembly Area: Pharmacy Tech work area with access to carousel and/or storage shelving for filling orders and assembling medications for ADM restock.

Processing Area: Pharmacist workstation for initial receiving/validation of medication orders and conducting phone consultations with providers.

Secured Dispensing / Storage: Restricted access work area for storing/ processing narcotics and controlled substances. Includes space for expired drug collection/disposal.

Filling / Assembly Shelving: Active shelving for storage of drugs and medication supplies required for filling orders.

Filling / Assembly Carousel: Automated storage and retrieval system for drugs and medication supplies required for filling orders. Space includes static shelving for overstock or bulky items that are not compatible with the carousel bins.

Repackaging Area: Work area and equipment for processing bulk medications into individual unit doses

Expired Drug Collection: Secured collection bins for expired/waste medications for return or disposal.

Restock Area, Crash Cart: Work space and storage area for crash cart replenishment and maintenance operations.

Non-Sterile Compounding Area: Work area for conducting Category 1-nonsterile / simple compounding activities.

Sterile Non-Hazardous Drug Buffer Room: Positive pressure buffer area / clean room for mixing, transferring, and assembling components of non-hazardous drug compounded sterile preparations.

Sterile Hazardous Drug Buffer Room [C-SEC]: Negative pressure buffer area / clean room for mixing, transferring, and assembling components of hazardous drug compounded sterile preparations.

Sterile Hazardous Drug Storage: Negative pressure space for storing sterile compounding operations.

Work Area, Sterile Compounding: Non-sterile work area adjacent to clean rooms for support of both hazardous and non-hazardous compounded sterile preparation activities

Ante-room, Sterile Compounding: An ISO Class 7 or cleaner room where personnel hand hygiene, garbing procedures, and other activities that generate high particulate levels are performed. The ante-room is the transition room between the unclassified area of the facility and the buffer room.

Storage, Sterile Compounding: Storage for sterile fluid bags and IV admixture materials and supplies.

Housekeeping, Sterile Compounding: For storage of disposable cleaning supplies specifically for use in Sterile Compounding areas. Keep separate from general Pharmacy housekeeping supplies.

Inventory Receiving / Breakdown: Space for receiving, verification, and breakdown of deliveries.

Procurement: Work area for inventory control/stock management staff.

Investigational Drug Services (IDS): Work space for conducting investigational drug studies, including space for securable filing cabinets and refrigerator.

Pharmacy Cache: Secured storage space for emergency medical supplies and pharmaceuticals. Actual NSF required for pharmaceutical portion of storage may vary by project - to be determined during planning process.

2.1.5 Outpatient Pharmacy

Figure 2.2 Gainesville VAMC Outpatient Pharmacy

The Outpatient Pharmacy is comprised of all functional areas required to receive, process, fill, store and distribute all manners of medications to the outpatient population in either the hospital or satellite pharmacy. The Outpatient Pharmacy should be easily accessible to public space near or on the path to major circulation spines of the facility and should have strong adjacency to outpatient clinics and main points of entry.

The Outpatient Pharmacy is also responsible for dispensing medications for discharge patients. Hospital protocol for discharge patients should be considered to help determine best location or flow between the Outpatient Pharmacy and the units the Outpatient Pharmacy is serving.

Security: Security will remain a concern when controlled substances are available. There is a balance between patient experience and security for both patient and the Pharmacy staff that needs to be taken into consideration when designing dispensing and consultation areas. The outpatient narcotic secured room is designed per the VA Construction Standard H-18-3, CD-49.

Refer to the Physical Security Design Manual for VA Mission Critical Facilities, for specific security measures.

2.1.6 Primary Outpatient Pharmacy Spaces and Functions

Dispensing and Consult Area: Work area with secure transaction windows / pass throughs for dispensing medication to patients, and for conducting general (non-confidential) consults with Pharmacists.

Dispensing Window: Secure transaction window with pass-thru for dispensing medication to patients; not intended for patient consults

Consult Window: Semi-private station located outside of secure Pharmacy perimeter for general (non-confidential) patient consults with Pharmacists; not intended for medication distribution; open configuration with no window or pass-through between patient and Pharmacist.

Consult Room: Private space for confidential patient consults with Pharmacists.

Filling / Assembly Area: Pharmacist / Technician work stations, and active shelving for storage of medications and prepackaged items required for filling of prescriptions.

Automated Filling / Storage: Space for automated filling robot, and for storage of bulk medications and supplies.

Processing Area: Pharmacist workstation for initial receiving and validation of prescriptions, and for conducting phone consultations with providers. Can also accommodate Community Care coordination.

Secured Dispensing / Storage: Restricted access work area for storing / processing narcotics and controlled substances. Includes space for packaging and holding mail-out prescriptions, handling returned mail, and for expired drug collection / disposal.

Mail Out Area: Work space for packaging and shipping of filled prescriptions, and for processing returned mail.

Expired Drug Collection / Disposal: Secured collection bins for expired/ waste medications for return or disposal.

Discharge Pharmacy: Work area for provider coordination and processing of medications prior to patient being released from inpatient / emergency care.

Call Center: Space for Pharmacy Technicians to conduct phone consults with patients.

Inventory Receiving / Breakdown: Space for receiving, verification, and breakdown of deliveries

Procurement: Work area for inventory control/stock management staff.

Storage: Storage for non-medicinal/bulky items/supplies required for filling of prescriptions, i.e., Prosthetics.

2.1.7 Satellite Pharmacy

Inpatient satellite pharmacies can be in a number of departments to help support immediate needs that would require a dedicated Pharmacist. The needs of the facility should be discussed at the time of design in an effort to provide the best level of care possible. A Satellite Pharmacy could be included in Oncology, Surgical Services, Intensive Care Units, Neurology, Cardiac Services, Emergency Services among other departments and nursing units.

In addition to inpatient satellite pharmacies located within the hospital proper, Long Term Care and Mental Health Residential Rehabilitation and Treatment Programs could use a Satellite Pharmacy managed by the Inpatient Pharmacy that is not in the hospital.

Satellite Pharmacies are not included in this design guide as they are specific to the modality they serve and should be addressed within those specific design guides.

2.1.8 Waste Management

Rx Waste: Expired drug waste is generated most often by the medication shelf life running out. Expired medication is collected by their drug categories in a designated central accumulation area for either reverse distribution, if applicable, or collected for disposal and taken to the loading dock to be held in a secured location until pick up. This includes, but not limited to partial vials, hospital repacks, un-dispensed, pre-filled syringes, partial syringes, discontinued medications, unadministered medications, patient prescriptions, and physician RX samples.

Hazardous Rx Waste: Hazardous waste is collected separately from Rx Waste and stored in a secured location, typically adjacent to the loading dock, until such time a licensed hazardous waste hauler can collect and transport it.

Sharps: Sharp containers shall be located at key locations to allow for immediate disposal in areas where syringes will be used. Sharps container are used to dispose partial, full or used syringes and will be collected separately for proper disposal.

Satellite Rx Accumulation Areas: Satellite accumulation areas should be discussed with each facility and identified in patient care areas. Regular collection of expired and unused medications in these satellite locations should be discussed and planned for.

General Waste: General waste is generated in all spaces and held in waste containers within the various rooms or bulk storage in the receiving area. The waste is then collected by cart and transported via the loading dock to a waste handling facility.

Recycling: The sorting, collecting, transporting and disposing of recyclable material should be analyzed by locality and modified to suit local conditions and practices.

Product types used in the Pharmacy: disposable vs. recyclable products should be discussed as it is an important design consideration that impacts physical space, pharmacy operations, staffing and waste disposal volumes.

Refer to the NEPA Interim Guidance for Projects for more information regarding recycling requirements.

2.2 Trends in Pharmacy

Over the years there have been numerous updates to Pharmacy function, operation and delivery of care. Below are some key elements of significant changes to note.

2.2.1 Research Based Design

Although using design to affect outcomes is not a new concept, the use of research based design has become common in helping designers and facilities determine courses of action that help in the design of safer and more patient centric environments based on real data and outcomes. One such example is medication errors, which can derive from poor lighting, ergonomics, fatigue, distractions and general lack of efficiency can all be improved with research based solutions.

2.2.2 Technology Advancements:

Robotics play a significant role in the reduction of medication errors, efficiency of staff as well as how drugs are stored, filled and delivered.

Robotics in conjunction with conveyor systems for outpatient pharmacies bring the medication to technicians for filling, limiting technician fatigue, thereby reducing medication errors.

Advancement in automated medication storage and dispensing systems is significantly helping facilities with inventory control and space management for medication storage. Storage systems like medication carousels increase the amount of medications that can be stored in a given square footage when compared to static shelving by condensing the storage need in a compact and vertical solution. These systems save square footage requirements and also staffing assigned to manual check par levels on a regular basis.

Figure 2.3 Orlando VAMC Inpatient Pharmacy Robotics

Specialty equipment such as compounding robotics have also been advancing to help in repetitive tasks with high volume. Given the right conditions and facility needs, robotics are able to provide a significant savings in operation and possible FTE costs.

2.2.3 Codes and Standards

With advancement in research studies of the long term effects of medication exposure to staff, there have been significant updates to the USP chapter <797> Pharmaceutical Compounding - Sterile Preparations, and the addition of the USP chapter <800> Hazardous Drug - Handling in Healthcare Settings. These chapters are provided by the United States Pharmacopeia (USP) to help mitigate workplace exposure in the sterile environments with potential exposure to hazardous drugs.

2.2.4 Meds to Beds

The Meds to Beds concept describes part of a discharge process where the patient receives prescriptions, hand delivered at bedside, before or during discharge. The theory behind Meds to Beds is to not only limit the number of stops and wait time a patient has before leaving the hospital by eliminating the need to visit the outpatient pharmacy after being discharged, but also to make sure the patient receives their medication, the medication is explained to them and the patient has the ability to have their questions answered by a pharmacist.

There are benefits to this program as well as challenges with staffing and current practices. Revised communication protocols between nursing and pharmacy staff will need to be discussed with the stakeholders to determine if it is right for the facility, works with their current or future staffing demand and nursing unit configuration.

2.2.5 Storage

Figure 2.4 Inventory management system

Advanced storage systems and inventory management with just-in-time deliveries from vendors, results in storage needs that have the potential to be reduced, or at the very least better managed through integrated tracking systems. Using these types of storage systems could help eliminate medication shortage or stock overruns that could lead to more expired medications.

2.2.6 Consolidated Mail Outpatient Pharmacy (CMOP)

Figure 2.5 Hines VA CMOP

The VA Mail Order Pharmacy processed 119.7 million outpatient prescriptions in fiscal year 2016. The Department of Veterans Affairs provides approximately 80% of all outpatient prescriptions to Veterans via mail order utilizing the VA Mail Order Pharmacy, a system of 7 highly automated pharmacies.