USP 797-800 Pharmacy Planning & Design

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ARRAY USP 797/800 PHARMACIES

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Our Firm in Brief

After 35 years serving healthcare clients, we’ve learned that it’s never just about the building. Every problem and challenge our clients face are unique opportunities to adapt, improve or transform­—and they all require something different. That’s why we are so much more than just healthcare architects. Our integrated services align analysts, advisors, and architects to provide a complete continuum of project exploration and execution. Guided by process, powered by collaboration and built around an innovative culture.

100%

DEDICATED TO HEALTHCARE

FIVE LOCATIONS NATIONWIDE We’re strategically located throughout the country to engage with clients on site, to optimize results. • Boca Raton, FL

• Philadelphia, PA

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Array | PAGE 2

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T E C H N O L O G Y

Array Analytics is an innovative think tank of analysts and product developers dedicated to helping healthcare systems identify and contextualize business drivers. These days, big data is critical to making informed decisions, but information must be distilled and interpreted to truly be valuable. We developed the platform you need to dynamically draw upon real-time industry data, combine it with your own, and leverage it so you can visualize relevant business drivers and opportunities. Array Analytics is the foundation upon which targeted solutions drive transformation in healthcare business. •

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S T R A T E G Y

Array Advisors is a multi‑disciplinary team providing custom solutions to optimize healthcare operations and solve business challenges. When addressing the distinct needs of any healthcare business, there is no solution without informed preparation and consideration. It requires a nuanced approach of dedicated professionals with a variety of viewpoints. We uncover the opportunities buried within your challenges by untangling the complexities of those problems, and then engineering a solution using industry-leading tools and techniques. •

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D E S I G N

Array Architects is committed to improving healthcare outcomes by providing design solutions informed by integrated insights from perspectives across the organization. No brick is placed without considering its placement. No wall is raised without determining its integrity. No systems are installed, no colors are applied, no impact is made without a careful reasoning for doing so. We don’t address needs—we address your needs­—taking into account the context of a project and assembling a roster of experts whose combined strengths align to give your project life, value and spirit beyond its basic function. •

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Pharmacy Expertise & Project Experience


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Pharmacy Expertise The design of USP <797> and <800> compliant clean room spaces within pharmacies requires proper work flow and equipment placement, positive and negative air flows as well as smooth and impervious surfaces. Below, please find a representative listing of Array’s recent relevant pharmacy experience: • Baptist Health South Florida South Miami USP 797/800 Pharmacy, Miami, FL • Baptist Health South Florida Miami Cancer Institute USP 797/800 Pharmacy, Miami, FL • Baptist Health South Florida Baptist Hospital of Miami East Campus Bed Tower USP 797/800 Pharmacy, Miami, FL • Blanchard Valley Health System, USP 800 Pharmacy Upgrades, Findlay, OH • Capital Health Hopewell Med Center, 780 SF Retail Pharmacy & 3,750 SF Inpatient Pharmacy in a Greenfield Hospital, Pennington, NJ • Capital Health Regional Medical Center, 5,000 SF Replacement Pharmacy, Trenton, NJ • Capital Health Regional Medical Center, USP 800 IV Prep Pharmacy, Trenton, NJ • Chesapeake Regional Medical Center, USP 797/800 Pharmacy, Chesapeake, VA • Inspira Health USP 797/800 compliant Pharmacy, Mullica Hill, NJ • Jefferson Health Navy Yard, USP 797 Pharmacy, Philadelphia, PA • Jupiter Medical Center, 4,300 SF Pharmacy, Jupiter, FL • Kaiser Permanente, Urgent Care Pharmacy, Temple Hills, MD • Kaiser Permanente, Pharmacy Study, Woodbridge, VA • Kings County Hospital, 2,632 SF USP 797/800 Pharmacy, Brooklyn, NY • MedStar Georgetown University Hospital Infusion Suite, Washington, DC • MedStar Pharmacy Clean Room, Washington, DC • Miami Children’s Hospital, Nicklaus Children’s Cancer Center - USP 797/800 compliant Pharmacy, Miami, FL • Montefiore Medical Center, 2,300 SF Pharmacy in an Ambulatory Surgery Center, 600 SF Retail Pharmacy for Ambulatory Surgery Center and 1,470 SF Pharmacy for Ambulatory Oncology, Bronx, NY • Mount Sinai St. Luke’s Hospital, USP 797/800 Pharmacy, New York, NY • Mount Sinai Chelsea USP 797/800 Pharmacy, New York, NY • NYC Health + Hospitals Henry J. Carter Specialty Hospital, 3,000 SF Pharmacy in a Long Term Acute Care Facility , New York, NY • Nemours / Alfred I. duPont Hospital for Children, 4,830 SF Pharmacy, Wilmington, DE • New York Presbyterian, Research Pharmacy Relocation, New York, NY • NYU Langone Perlmutter Cancer Center, USP 797/800 Pharmacy , Brooklyn, NY • Nicklaus Children’s Hospital Center for Cancer & Blood Disorders USP 797/800 Pharmacy, Miami, FL • Northwell Health 3,000 SF Pharmacy in Psychiatric Hospital, Glen Oaks, NY • Penn State Hershey Medical Center, 1,500 SF Pharmacy in Cancer Institute, Hershey, PA • Tower Health, 3,190 SF Main Pharmacy, 1,180 SF Satellite Pharmacy and 2,783 SF Pharmacy Support, Reading, PA • Steward Health Sharon Regional Medical Center, 600 SF USP 797/800 Pharmacy Upgrades, Sharon, PA • Steward Health St. Anne’s Hospital, USP 80 Pharmacy, Fall River, Massachusetts • Steward Health Hawthron USP 800 Satellite Pharmacy, Dartmouth, Massachusetts • Somerset Medical Center, 3,520 SF Pharmacy in Regional Cancer Center, Somerville, NJ • Shriners Hospital for Children, 3,000 SF Pharmacy, Philadelphia, PA • University Hospitals, System-Wide 17,100 SF USP 797 Compliance Upgrades, Cleveland, OH • University of Maryland Medical Center, Pharmacy Consolidation Study and USP 797/800 Pharmacy Upgrades, Baltimore, MD • University of Pennsylvania Health System, Pennsylvania Hospital 6,500 SF Pharmacy, Philadelphia, PA • Veterans Affairs Medical Center, 2,800 SF Inpatient Pharmacy, Brooklyn, NY • Veterans Affairs Medical Center, 6,200 SF Outpatient Pharmacy Pebble Project, East Orange, NJ • Veterans Affairs Medical Center, 150,000 SF Outpatient Clinic, Greenville, NC • Virtua Health, Pharmacy Study, Marlton, NJ Array | PAGE 5

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Equipment, Workload & Hours of Operation Clean Room Baltimore, MD

University of Maryland Medical Center Pharmacy Consolidation Feasibility Study & Implementation Construction Estimate:

– Average daily 15-20 – Peak daily 30

January 2017 Consulting Completion:

75%

• ChemoShield Glovebox(2)

Inpatient Adult

– Average daily 60-100 – Split between both glove boxes

(includes BMT, peds, OR)

25%

Anteroom • Non-hazardous glovebox (1)

MondayFriday

6:30a – 7p

– Average Daily 33% of total doses – Peak Daily 67 (45% of total doses)

Saturday

7:30a – 4p

Sunday

7:30a – 4p

Staffing

$4,679,864.00 Consulting Start:

Stoler Infusion (includes peds heme onc, interventional rad)

• Apoteca chemo robot (1)

Techs

Pharmacists

Oncology Clinical Specialists

4

4

2 (+2)

PGY-2 Oncology Resident

1

July 2017 Design Start:

6:30a

7:00p

October 2020 Construction Completion: July 2021

Client Contact

4th year pharmacy students – 5 week rotations 2 student per year

Project Information

Bret Elam Capital Program Coordinator University of Maryland Medical Center 410-328-7745

• 7,644 SF Renovation – 7,045 SF North Building central pharmacy – 316 SF Shock Trauma Center pharmacy compliance upgrades • Review several existing pharmacy spaces, including main pharmacy and several satellite pharmacies, to: – Understand current challenges – Streamline and create efficiencies – Consider consolidating compounding services

Array | PAGE 6


New & Expanding Services Cord Blood transplants

CAR-T Cell

Expand BMT program

Growing Cancer Center

Expand proton therapy

Infusion Volumes & Growth

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Absolute Month to Month Infusion Volume Change

Jul-09

Initial XmR Chart of Infustion Data

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Absolute Month to Month Change

Infusion Volume

Jul-09

Adjusted XmR Chart of Infusion Data

Array performed a consolidation study of several buildings on the University of UMMC • 07.31.2017

Proposed Program & Space Needs

Maryland Medical Center’s (UMMC) campus with a Pharmacy focus. Tasks included: • Looking at the current work flow of their Central Pharmacy space and Main Storeroom • Looking at their current investigational drug and infusion compounding spaces and volumes for potential efficiencies • Receiving data of their compounding volumes and IV bag times (throughput) to analyze hood needs • Upgrading their current Katz Pharmacy (part of Stolar Infusion) hazardous

6,551

Katz Pharmacy

665

IDS Pharmacy & Storage

1,434

Prop osed D GSF

Consol i d a ted Pha rma cy Prop osed Sp a ce

E xi sti ng Pha rma cy – M a i n, K a tz & ID S

E xi sti ng D GSF

Main Pharmacy & Storeroom

Main Pharmacy & Storeroom

11,000

Consolidated Compounding Pharmacy & Haz Drug Storage

2,400

IDS Storage & Workroom

1,400

Pyxis team – Work Area

400

8,650

T OTAL DGSF

T OTAL DGSF

15,200

compounding space to comply with USP 800 (which ideally would be merged with the hazardous investigational drug compounding needs) Array is currently working on the design implementation with construction slated to complete in July 2021. UMMC • 07.31.2017

Input Data Validation

IDS

Apoteca

Katz

Given Volumes Hazardous ChemoShield - 2

Non-Hazardous Glovebox - 1

• Average daily volume 60-100 • Split between both glove boxes

• Average daily volume 20-40

Model Volumes

Hazardous Apoteca - 1 • Average daily volume 15-20 • Peak daily - 30

Hazardous ChemoShield - 2

Non-Hazardous Glovebox - 1

• Average daily volume 25 IV prep • Split between all three hoods

• Average daily volume 15 oral preparation

Array | PAGE 7


Vero Beach, FL

Cleveland Clinic Indian River Hospital Cancer Center Construction Cost: $14,000,000 Design Start: September 2013 Completion: October 2015

Collaborators: Masteller & Moler TLC Engineering for Healthcare WellsAppel WZG Structural Engineers

Client Contact Richard Van Lith Director, Business Development Cleveland Clinic Indian River Hospital 772-567-4311

Project Information • 2017 Winner of Modern Healthcare Bronze Award • 20,000 SF New Construction/Addition • 14,000 SF Radiation Oncology Building Renovation • USP 797 Pharmacy • New canopied drop-off • Reconfigured campus loop road • Infusion Therapy • Radiation Therapy • Survivorship Programs • Two healing gardens • Pedestrian connection to Health & Wellness Center • Integrated oncology clinic • Lab services • Patient and family resource center • Affiliated with Cleveland Clinic • Awarded Indian River Economic Development award for New Large Building Construction (2016)

Array | PAGE 8


With an integrated multi-specialty Health & Wellness Center being designed by Array for the campus, Cleveland Clinic Indian River Hospital selected the same design team to bring a new Cancer Center to the community. An existing Radiation Oncology pavilion dictated the location of the new Center at a congested nexus of the campus. The new Scully-Welsh Cancer Center, affiliated with Duke University, brings state-ofthe-art, compassionate care to the Indian River community. The Cancer Center features multi-modality clinics, integrated treatment planning, infusion, radiation therapy, rsurvivorship, esource and education programs, and access to clinical trials and research. In a bucolic setting within the Indian River campus, a healing garden links the Cancer Center and Health & Wellness Center, creating new, dedicated open space on campus. The new Cancer Center establishes the Medical Center’s brand for the expanded cancer program through the design of both the patient experience and the building. Together, the Cancer Center and the Health & Wellness Center form a new outpatient campus, in-sync with the renowned Cleveland Clinic’s image and reputation for worldclass comprehensive cancer care, close to home.

Array | PAGE 9


Miami, FL

Baptist Health South Florida Miami Cancer Institute USP 797/800 Pharmacy Construction Cost: $20,000,000.00 Design Start: November 2015 Completion: April 2018

Collaborators Bliss & Nyitray JLL Healthcare Solutions Robins & Morton TGA Design TLC Engineering for Architecture

Client Contact Ron Bowes Senior Project Manager Robins & Morton 305-661-0036

Project Information • 80,000 SF Fitout – 1,500 SF USP 797/800 Pharmacy • Outpatient Oncology Services • Integrated Palliative Care • Outpatient Bone Marrow Transplant Treatment and Research • Bio-specimen Repository Facility • Genomic Testing and Research Lab • Clinical Trials • Administrative & Executive Offices

Array | PAGE 10


Array was engaged to provide operational improvement, programming and design services for the fitout of the Cancer Research Building on the new campus of the Miami Cancer Institute. The Institute, affiliated with Memorial Sloan Kettering, represents the unifying connection between research and clinical care. Each workflow and space was studied, tested and crafted to represent the balance between integrated research and supreme patient care. Truly affording “benchto-bedside” care through genomics testing and clinical trials, MCI also explored new avenues in other holistic realms of healthcare as it sought to redefine the characteristics and environment for palliative care. The satellite pharmacy, which serves the building’s Clinical Trials and Bone Marrow Transplant components, is designed to facilitate the intake and breakdown of shipments and creation of medication to be administered to patients on-site. The design team was challenged with creating a pharmacy to support maximum workflow efficiency between several rooms that have varying degrees of highly-specialized functional and adjacency requirements, all within a modest footprint. The USP 800-compliant negatively pressurized hazardous compounding room contains two ducted bio-safety cabinets to support the creation, dispensing, transportation, receiving and administration of hazardous drugs. The USP 797-compliant positively pressurized sterile compounding room contains two recirculating laminar air flow workstations that facilitate the creation of medication intended for infusion, injection or application to the eye.

Array | PAGE 11


New York, NY

NYU Langone Health Radiation Oncology & Infusion Center Construction Cost: $32,565,299.00 (entire building) Design Start: September 2016 Completion: April 2019

Collaborators Grifols Hunter Roberts Reuther + Bowen Syska Hennesy Group

PHARMACY

Client Contact Carmelo Crisafuli Real Estate Development and Facilities NYU Langone Medical Center 929-455-2422 Thomas del Corral Director, Pharmacy for Cancer Center & Ambulatory Services NYU Langone Medical Center 212-701-5146

Project Information • 26,700 SF Oncology Radiation and Infusion Treatment Center • 1,026 SF Pharmacy, including: – Anteroom – where gowning takes place (ISO 7) – Buffer room – non-hazardous sterile product preparation (ISO 7) – Chemo room – hazardous sterile product preparation (ISO 7) – All Biosafety Cabinets (ISO 5) – Pharmacy Workroom – Pharmacy Supervisor Office – Bulk Receiving Area – Secure Storage • 685 SF Laboratory Suite, including: – Clinical Lab – Phlebotomy/Fast Track Exam Room – Intake Area – Lab Supervisor Office

Array | PAGE 12


The renovation of this building will increase NYU Langone Hospital – Brooklyn’s ability to serve their community’s oncology treatment needs closer to home. The 26,700 SF facility will house both Radiation Oncology and Infusion Therapy with a USP 797/800 compounding pharmacy and laboratory suite supporting and located on the same floor as the 21-bay Infusion Center. This will allow staff to efficiently treat patients efficiently with on-site pharmaceutical compounding. The design features product receiving and storage, a supervisor office and pharmacy work spaces including the main workroom, ante-room and USP 797 and 800 compliant sterile drug compounding rooms, one for non-hazardous drugs and one for hazardous chemotherapy drugs. A pass-through allows convenience between the chemotherapy room and main pharmacy workroom. All new mechanical systems will be provided to meet ISO 7 requirements, air changes and the positive and negative pressure differentials required in these cleanroom spaces. Prefabricated, modular clean room flooring and ceiling panels are used in the ante and sterile compounding rooms. This includes all required air pressure and humidity sensors, display monitors, cleanroom phones and melaphone connection between the work room and compounding rooms. Directly adjacent to the infusion space is the laboratory and includes various analyzers, a centrifuge, incubator, refrigerators and freezers, and infrastructure for lab-specific deionized water system.

Array | PAGE 13


Bronx, NY

Montefiore Medical Center Ambulatory Care Center USP 797 Pharmacy Construction Cost: $65,000,000 Design Start: August 2011 Completion: December 2014

Collaborators BR+A Cauldwell Wingate Newman Design Reuther + Bowen Simone SM&W

Client Contact

Project Information • 2,300 SF Pharmacy

Christopher Shaw

• USP 797 Compliant

Vice President, Healthcare Leader LF Driscoll Healthcare Christopher.shaw@lfdriscoll.com 212-251-9271

• 64 Recovery Bays • Servicing Predominantly 12 ORs, 4 Procedure RMs & Pain Center • Function Components Include Bulk breakdown, Active storage, Narcotics vault & Staff work/office space • Direct Pneumatic Tube Access to Ambulatory Procedure Floors • Electronic systems used to accurately measure dosage and maintain electronic records

Array | PAGE 14


The Montefiore Medical Center Ambulatory Care Center is a 12-story multidisciplinary facility within the newly developed Hutch 2 Tower part of a Class A office complex. Array provided planning and design services for the complete fitout of 12 stories at the newly developed Hutch 2 Tower – part of a Class A office complex convenient to the Medical Center. The Ambulatory Center incorporates a full imaging suite with two MRIs, two CTs, four Rad rooms, mammo and ultrasound rooms on the 2nd floor of the building. All seven upper clinical floors are based on modules and pods so that space can easily be increased or decreased between groups as needed. Rooms can easily swing from office to consult to exam rooms due to rough ins. The USP-797 Pharmacy supplies the 16-room surgical complement, as well as the Pain Management Center. With direct pneumatic tube service to the procedure floors, patient care is efficient and focus is kept at the bedside.

Array | PAGE 15


Bronx, NY

Montefiore Medical Center Ambulatory Oncology Center Construction Cost: $5,500,000 Design Start: October 2011 Completion: 2013

Collaborators Bladykas Engineering Metropolis Group Reuther + Bowen Tower Property Management

Client Contact Tom Tropea Senior Project Manager of Facilities and Real Estate, Planning,

Project Information • 20,000 SF renovation

Montefiore Medical Center

• 23 new infusion bays

90 East 210th Street, Bronx, NY 10467

• 16 new physician offices

914-557-5019

• 6 staff offices • 17 exam rooms • 1,740 SF USP 797 Pharmacy • 415 SF Lab • 284 SF Phlebotomy

Array | PAGE 16


To better serve patients, Montefiore Medical Center engaged Array to provide design services for the Ambulatory Oncology expansion program in the Montefiore Medical Park Building, which includes the partial renovation of the existing first floor and the entire second floor. T he Ambulatory Oncology Phase I Program located on the first floor was relocated to the second floor, along with the fit out for the Moses Gold Zone Ambulatory Oncology Program (exams and offices) and administration function. Upon completion, work commenced on the partially-vacated first floor space to expand the existing Ambulatory Chemotherapy Unit. The existing Chemotherapy Unit had areas of renovation, and the expanded Chemotherapy Unit now operates in two distinct suites. The Pharmacy on the first floor was expanded to support the growth of the Chemotherapy Unit and is USP 797 compliant. The Pharmacy had continued operation during the course of construction. The Pharmacy has features including investigational medication area and positive & negative clean rooms. Clean room functions opened directly from the centralized ante room. Dispensing of prepared IV solutions will occur through secured air lock pass box accessed by a card reader lock. The boxes open directly into Infusion for efficient retrieval. The separate US 797 compliant negative / positive clean rooms will be furnished with five biological safety hoods. An automatic sliding door provides convenient access for staff to the positive pressure room. These rooms are supplied through the ante room from a receiving breakdown room and active storage. To maximize storage a rolling high density shelving system is used. Array | PAGE 17


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