constructing a modern cytology laboratory a toolkit for planning and design

Research Article Constructing a modern cytology laboratory: A toolkit for planning and design Isam A.. Methods: The phases of any laboratory design project are Planning, Schematic Desig

Research Article

Constructing a modern cytology laboratory: A toolkit for planning and design

Isam A Eltoum, MD, MBA*

Address: Department of Pathology, Division of Anatomic Pathology, University of Alabama at Birmingham, USA

E‑mail: Janie Roberson ‑ jroberson@uabmc.edu; Allison Wrenn ‑ awrenn@uabmc.edu; John Poole ‑ jpoole@pooleandcompany.com; Andrew Jaeger ‑ ajaeger@hksinc.com; Isam A Eltoum* ‑ ieltoum@uab.edu

*Corresponding author

This article is available from: http://www.cytojournal.com/content/10/1/3

© 2013 Roberson, et al.; licensee Cytopathology Foundation Inc.

Abstract

Introduction: Constructing or renovating a laboratory can be both challenging and rewarding

UAB Cytology (UAB CY) recently undertook a project to relocate from a building constructed in

1928 to new space UAB CY is part of an academic center that provides service to a large set of

patients, support training of one cytotechnology program and one cytopathology fellowship training

program and involve actively in research and scholarly activity Our objectives were to provide a

safe, aesthetically pleasing space and gain efficiencies through lean processes Methods: The phases

of any laboratory design project are Planning, Schematic Design (SD), Design Development (DD),

Construction Documents (CD) and Construction Lab personnel are most critical in the Planning

phase During this time stakeholders, relationships, budget, square footage and equipment were

identified Equipment lists, including what would be relocated, purchased new and projected for future

growth ensure that utilities were matched to expected need A chemical inventory was prepared

and adequate storage space was planned Regulatory and safety requirements were discussed Tours

and high level process flow diagrams helped architects and engineers understand the laboratory

daily work Future needs were addressed through a questionnaire which identified potential areas

of growth and technological change Throughout the project, decisions were driven by data from

the planning phase During the SD phase, objective information from the first phase was used by

architects and planners to create a general floor plan This was the basis of a series of meetings to

brainstorm and suggest modifications DD brings more detail to the plans with engineering, casework,

equipment specifics, finishes Design changes should be completed at this phase The next phase,

CD took the project from the lab purview into purely technical mode Construction documents

were used by the contractor for the bidding process and ultimately the Construction phase

Results: The project fitted out a total of 9,000

square feet; 4,000 laboratory and 5,000 office/

support Lab space includes areas for Prep,

CT screening, sign out and Imaging Adjacent space houses faculty offices and conferencing facilities Transportation time was reduced (waste removal) by a Pneumatic Tube System,

This article may be cited as:

Roberson J, Wrenn A, Poole J, Jaeger A, Eltoum IA Constructing a modern cytology laboratory: A toolkit for planning and design CytoJournal 2013;10:3.

Available FREE in open access from: http://www.cytojournal.com/text.asp?2013/10/1/3/107983

Vinod B Shidham, MD, FIAC, FRCPath (WSU School of Medicine, Detroit, USA)

Vinod B Shidham,

MD, FIAC, FRCPath Wayne State University School

of Medicine, Detroit, MI, USA

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DOI:

10.4103/1742-6413.107983

INTRODUCTION

Constructing or renovating a laboratory can be both

challenging and rewarding The UAB Cytology Section

recently had the opportunity to relocate services from

a building constructed in 1928 to a new space The

laboratory provides diagnostic and screening services

for UAB Medicine patients, which include a 1000‑bed

hospital and a large Outpatient Clinic Over 20,000

tests, including both conventional and liquid‑based

gynecological cases, 1000 fluid specimens, 2000 Fine

Needle Aspirations (FNA), and 1000 pulmonary cases

are processed annually Internally, the section supports

an onsite rapid FNA service for Endoscopic Procedures

(EUS) as well as for Mammography and Bronchoscopy

(EBUS) The technical and professional staff attend and

perform FNAs throughout the inpatient and outpatient

areas The laboratory serves as a clinical affiliate site for

Cytotechnology Programs, supports two Cytopathology

Fellowships, Residents, and a Professional staff, active in

research and publication As an academic institution, our

mission includes patient care, research, and education;

and our facilities must be able to accommodate these

functions seamlessly

Our challenge in the laboratory design and building

project has been to develop a plan that demonstrated

flexibility, safety, quality of environment, and cost

efficiency Flexibility is important, as laboratory testing

is constantly changing and to remain competitive, we

must be able to accommodate future growth in both

test volume and diversity Safety of the employees

is a major concern in areas with potential chemical

exposure and biohazards Additionally, there are

numerous agencies, with applicable safety mandates,

which require compliance A well‑designed, high‑quality

work environment is evidence of our commitment to

patients and employees and fosters satisfaction and

high performance among the staff As a teaching facility,

recruiting the best staff available is a priority and top‑level

facilities attract top‑level staff Cost efficiency is always

a concern and can be a limiting factor, if not carefully

monitored throughout the planning and design.[1]

METHODOLOGY

Once a project has been approved in concept, the core stakeholders must be identified and assembled as a project team The composition of this group will vary depending

on the facility type Even as academic institutions, corporate laboratories, and hospitals have variable business models, there are common roles and areas of expertise that must be represented in the composition of the project team Each member will have expectations to

be met during specific phases of the project[2] [Figure 1] The phases of project design are Planning, Schematic Design (SD), Design Development (DD), Construction Documents (CD), and Construction.[3]

PLANNING

Laboratory participation (User Group) is the most critical

in the planning phase Detailed information regarding the methodologies and scope of testing performed by the laboratory must be compiled and conveyed to the others

on the project team Administrative and facility members also participate, to ensure that the plans remain within the financial and physical constraints and are aligned with long‑term institutional strategies

Tours and high‑level process flow diagrams can bring

Figure 1: Project team composition

specimen drop window to Prep Lab and a pass thru window to the screening area Open screening

and prep areas allow visual management control Efficiencies were gained by ergonomically placing

CT Manual and Imaging microscopes and computers in close proximity, also facilitating a paperless

workflow for additional savings Logistically, closer proximity to Surgical Pathology maximized the

natural synergies between the areas Conclusions: Lab construction should be a systematic

process based on sound principles for safety, high quality testing, and finance Our detailed planning

and design process can be a model for others undertaking similar projects

Key words: Cytolaboratory design, laboratory design, lean methods, quality control, laboratory

construction, cytopathology equipments, cytopathology procedures

an understanding of the daily work in the laboratory to

architects and engineers Awareness of the appropriate

relationships and adjacencies are essential to the design

for a smooth flow of personnel, supplies, and equipment

The strength and complexity of these relationships can be

illustrated through a bubble diagram [Figure 2]

Any discussion of an efficient facility design must

include planning for sustainable design and Lean

operations For example, materials handling is estimated

to consume 20‑50% of the operating expense in a variety

of production and manufacturing settings, not atypical

of laboratories Efficient facility design can reduce these

costs by 10‑30%; an excellent return on investment over

the life of the facility.[4] Objectives of Lean facility planning

are, obtaining a smooth work flow, reducing the walking

distances and work in progress, improving visibility for

effective management of operations, and improving the

work environment and inventory management.[5]

Along with Lean design concepts, this detailed planning

information covers personnel, equipment, and future growth

The more information compiled at this stage, the more

completely the outcome will meet the user group needs

An equipment list with specifications, including what will

be relocated, newly purchased, and projected for future

growth, ensures that utilities are matched to need The

list must include: Footprint (dimensions and weight),

electrical requirements, computer or interface requirements,

uninterruptible power supply (UPS), alarm, dedicated

circuit, emergency power, ventilation or exhaust, and a

plumbing drain or deionized (DI) water [Table 1] Cut

sheets must also be available for each piece of equipment,

conveying any information needed to install or use the

product A quantitative chemical inventory is essential

to provide the appropriate storage space This inventory

must include the chemical name, storage requirements,

and volume stored [Table 2] Storage of used reagents and residual specimen containers/fixatives must also be included in this volume The National Fire Protection Association (NFPA) provides ratings for areas based

on volume and potential hazards Anatomic pathology laboratories, because of the high volumes of xylene and formalin, are typically rated as Class A

Regulatory and safety requirements must be discussed as they relate to the specimen sources and testing to be performed

A BioSafety level is the level of bio‑containment precautions required to isolate dangerous biological agents in an enclosed facility The levels of containment range from the lowest, BioSafety level 1, to the highest, level 4 In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels.[6] Once determined, this level will dictate many of the safety requirements for the laboratory Our project and the typical cytology wet laboratory space is designated as BioSafety Level 2 (BSL2)

Future utilization must be addressed through a questionnaire and/or discussions among stakeholders Even as future needs are difficult to predict, this exercise can identify the potential areas of growth and direction of technological change A universally accepted growth area

in laboratories is automation in processing and specimen tracking, which will necessitate more electrical and data capacity than in the previous workplace

DESIGN

Throughout the Schematic Design, data and information from the planning phase is used by architects and planners

to create a general floor plan This design provides the groundwork for a series of meetings, to brainstorm and modify the plan To ensure maximum efficiency, the workflow (movement of specimens) and traffic flow (movement of personnel) must be carefully evaluated during this phase [Figure 3]

Specimen preparation and result reporting are bookends to the cytological testing process, providing both pre‑analytic and post‑analytic support One of the objectives in the design of the preparation area is to allow two to three operators to effectively and simultaneously cover several instruments and functions To achieve this, handling and walking distances are minimized and open areas are provided to facilitate visual management Open work areas also allow managers to quickly assess the state of operations, inventory levels, and communication among workers, a key feature of Lean design Another key requirement of this area is broad accessibility to other functional areas, specimen couriers at all hours, pathology sign out area, cytotechnologist screening, and imaging and archive Many of the laboratory safety mandates directly impact

Figure 2: Bubble diagram illustrating strength and complexity of

relationships, both internal and external, to the laboratory

Network connection

Dedicated Circuit

Emergency Po wer

Vent out

ocessing Biohazar

the preparation area and must be built into the design for

appropriate plumbing and electrical support and ease of

access for staff.[7,8] A safety checklist is provided in Table 3

The Occupational Safety and Health Administration (OSHA)

regulates and the American National Standards Institute

(ANSI) provides standards (ANSI/ISEA Z358.1‑2009) for

emergency shower and eye wash station equipment OSHA’s

general regulation ([29 CFR 1910.151 (c)]) states that: “Where

the eyes or body of any person may be exposed to injurious corrosive

materials, suitable facilities for quick drenching or flushing of the

eyes and body shall be provided within the work area for immediate

In contrast to the preparation area, cytotechnologists

performing the analytic phase of testing, screening, and

diagnostics, require a workspace with more restricted access,

to minimize interruptions Multifunction workstations,

with carefully considered ergonomics, must be designed,

due to the repetitive nature of screening.[10] To reduce the

movement of personnel and specimens; the workspace is designed to accommodate both manual and automated microscopes as well as computers An open area, with individual work cubicles and a common resource area for educational materials, meets the needs of rotating trainees Slides ready to be screened are transferred from the preparation to the screening area using a ‘pass thru’ cabinet This minimizes interruptions and also helps to maintain the positive/negative airflow between the two areas Conferencing facilities are a high priority for academic institutions A multipurpose space is designed, allowing

a multihead microscope review as well as overhead projection and presentation resources A moveable wall provides the capability of separating the two functions as needed Locating this adjacent to the lounge facilitates food service, often a component of functions and conferences The Americans with Disabilities Act (July 26 1990) requires that public entities ensure that newly constructed buildings

Table 2: Chemical inventory with quantification and hazard classification

Chemical Inventory

Room #

Max In Inventory Physical State Health Flammability Reactivity

Corrosive

Thinprep® Nuclear Stain

and facilities are free of architectural and communication

barriers that restrict access or use by individuals with

disabilities The accessibility guidelines (ADAAG) are

numerous and detailed, however, compliance is relatively

simple if addressed early in the project [Table 5].[11]

Design development, the third phase, brings more detail

to the schematic design, with addition of engineering,

casework, equipment specifics, and finishes For long‑term

savings, requirements for sustainable design and energy

efficiency must be specified.[12] Examples of this are motion

sensor, timed lighting, and planned air conditioner

zones, to accommodate the heat generating equipment

Moveable casework will allow for adaptation to changing

instrumentation Use of open casework promotes the Lean

concept of visual assessment [Figures 4‑7]

As the project moves to Construction Documents, the

work transfers from the laboratory purview to a purely

technical mode At this point, due to costs, design changes

must not be made Architects and engineers provide more detail and specifications to allow qualified contractors to participate in the bid process

During the construction phase, architects and engineers serve as liaisons between the construction team and owners, to ensure compliance with the construction documents The user group tours the space periodically

to verify that the construction meets the expectations of the planning and design phases Change orders may be generated during this phase, however, they add to the project cost and must be minimized

Although not a phase of construction and beyond the scope of this article, it must be noted that detailed plans for the actual move‑in must begin early, as they can significantly impact the workflow and the project budget Vendors must be notified well in advance for quotes and schedules for equipment transport and set up Carefully developed detailed crosswalks from the old to the new

Figure 3: Schematic design illustrating movement of people and materials

Table 4: Eyewash and emergency shower specifications

Eyewash and Emergency Shower Specifications Plumbed Eyewash

Station

Plumbed Emergency Shower

Heads - Positioned 33"—45"

from floor

- Positioned 6" from wall

or nearest obstruction

- 0.4 gallons per minute (GPM) for 15 minutes (provides flushing fluid

at 30 PSI)

- Positioned 82"—96" from floor

- Spray pattern will have

a minimum diameter

of 20" at 60" above the floor

- Flow Rate=20 gallons per minute (GPM) at 30 pounds per square inch (PSI)

- Center of the spray pattern at least 16 inches from any obstruction Valves - Activate in 1 second or

less

- Stay-open valve (leaving hands free)

- Activate in 1 second or less

- Stay-open valve (no use

of hands) Valve remains on until the user shuts off Installation - Requires no more than

10 seconds to reach

- Located in a well-lit area and identified with

a sign

- Located on the same level as the hazard

- Requires no more than

10 seconds to reach

- Located in a well-lit area and identified with a sign

- Located on the same level as the hazard

Mainte-nance and Training

- Activated weekly to verify correct operation

- Training for all employees who might

be exposed to a chemical splash

- Inspected annually to ensure ANSI Z358.1 compliance

- Activated weekly to verify correct operation

- Training for all employees who might

be exposed to a chemical splash

- Inspected annually to ensure ANSI Z358.1 compliance

Table 5: Americans with disabilities act

requirements

Doorways

32” with the door open 90º degrees

Wheelchairs

Single wheelchair passage 32”at a point and 36”continuously

Turning space-60” clear space for 180º turn

Reach

Forward 15”-48”

Side (parallel approach) 9”-54”

Sinks and fountains

Spouts 36” maximum

Lavatories 34” maximum, at least 29” to the bottom of the apron

Knee clearance 27” high, 30”wide, and 19” deep underneath

sinks

Table 3: Safety checklist and BLSI 2

requirements

Requirements

Automatic fire extinguishing

system

Two exit access doors, if required

Audible automatic fire detection

and alarm system

Fire alarm station

Portable fire extinguishers

Emergency lighting

Flammable and combustible liquid

storage

Acid and base storage

Emergency eye wash

Hand washing sink

Emergency Shower

PPE Storage

BioSafety Cabinet Requirements

Negative and Positive

Pressurization areas

Chemical ventilation

BSL 2 Requirements

All BSL1 Requirements Gloves

Facial protection Hand washing with anti-bacterial soap

Disinfect all exposed surfaces of the lab Specific training in handling pathogenic agents directed

by scientists with advanced training

Limited access to the laboratory

Extreme precautions are taken with contaminated sharp items

Use of biological safety cabinets or other physical containment equipment when infectious aerosols or splashes may be created

space for phones and computers, ensure a seamless transfer

of this equipment Customers and supply chains must

be informed of the potential interruption of service The

vacated space must be cleared of all chemical and biological

hazards as well as any Protected Health Information (PHI)

RESULTS

At completion, the project fitted out a total of 9000 square

feet; 4000 square feet of laboratory space and 5000 square feet of office/support space The laboratory space included areas for preparation, CT screening, sign out, and imaging The adjacent space housed faculty offices, support staff, and conferencing facilities

Our objectives for building a Lean facility were essentially met The workflow was improved by moving specimens and their derivatives in a linear motion, from receipt to final verification Walking distances (transportation) were greatly reduced by the installation of a Pneumatic Tube System (PTS), specimen drop window directly into the Prep area, and a pass thru cabinet to the screening area Logistically,

Figure 4: Gyn-cytology processing elevation

Figure 5: Accessioning and staining coverslipping in an open work area

Figure 6: Accessioning, staining, flammable cabinet, and refrigerated storage

Figure 7: Elevation 07: Non-Gyn processing

closer proximity to Surgical Pathology maximized the natural

synergies between these areas Open floor plans for the main

functional areas and screening and preparation, improved

visibility for a more effective management of operations The

overall work environment was improved with better lighting,

aesthetics, conferencing facilities, information technology,

and employee comforts Inventory management was more

efficient, with accessible areas appropriate for short‑term

and long‑term storage Security was managed by key‑code

and card access entry and the slide archive area could only

be accessed by authorized individuals Surveillance cameras

were also strategically located for added security Efficiencies

were gained by ergonomically placing manual and imaging

microscopes in customized work cells for cytotechnologists

Location of computers in close proximity and the addition

of bar code scanners facilitated a new paperless workflow

for additional savings

SUMMARY

For Cytology, the past decade has brought tremendous

technological change to what for half a century, has largely

experienced predictable and constant practice Automated

stainers and cover slippers, liquid‑based processors, and

imaging systems are now a standard of practice in most

laboratories These advances in instrumentation require bench

space and facility modifications not seen in traditional cytology

laboratories With the expected decrease in volume of routine

Pap tests and growth and integration of molecular testing,

future cytology laboratories will demand an increasingly more

technologically sophisticated workplace Planning, design,

and construction must incorporate the flexibility to allow

this change at a minimal time and cost Infrastructure and

information technology must be able to support networked

instruments, mobile devices, wireless connectivity, digital

projection, and high quality audio‑visual technology

Successful laboratory construction must be a systematic

process, based on sound principles, to provide flexibility,

safety, quality of environment, and cost efficiency

Throughout the project, decisions must be driven by data

gathered in the planning phase This careful planning and

design can ensure that the laboratory we build today will

adapt to the laboratory we need tomorrow

COMPETING INTEREST STATEMENT BY

ALL AUTHORS

The author(s) declare that they have no competing interest

AUTHORSHIP STATEMENT BY ALL

AUTHORS

All authors declare that we qualify for authorship as defined by

ICMJE http://www.icmje.org/#author Each author aknowledges

that this final version was read and approval.

ETHICS STATEMENT BY ALL AUTHORS

This article content does not require approval from Institutional Review Board (IRB) at out institution Authors take responsibility

to maintain relevant documentation in this respect.

REFERENCES

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of Research and Development, Office of Facilities Management September

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2 Mortland K Laboratory Design for Today’s Technologies, MedTechNet East Amherst, NY; May 1997 p 1-14.

3 Clinical and Laboratory Standards Institute Laboratory Design; Approved Guideline ‑Second Edition CLSI document GP18-A2 [ISBN 1-56238-631-X]

Clinical and Laboratory Standards Institute 940 West Valley Road, Suite 1400 Wayne, Pennsylvania 19087-1898 USA, 2007.

4 Joseph T Design Your Laboratory of the Future Available from: http://www sprickstegall.com [Last accessed on 2011 Sept].

5 Lean Boot Camp: CLMA Immersion Day, presented by Susan Stegal www sprickstegall.com

6 Centers for Disease Control and Prevention, Summary of BioSafety Levels-1 and 2 http://emergency.cdc.gov/documents/PPTResponse/table3abiosafety pdf [Last accessed on 2012 Jan 18].

7 College of American Pathologist http://www.cap.org Lab General Checklist 7/11/2011

8 NCCLS Clinical Laboratory Safety: Approved Guideline‑Second Edition NCCLS

document GP17-A2 [ISBN 1-56238-530-5] NCCLS 940 West Valley Road, Suite 1400 Wayne, Pennsylvania 19087-1898 USA; 2004.

9 Eyewash and Safety Shower Requirements Available from: http://gesafety com/ansi/index.shtml Last accessed 02/2013.

10 Ergonomics Checklist Available from: http://www.ehs.ucr.edu/ehsacademy/ presentations/ergonomicslaboratorychecklist.pdf [Last accessed on 02/2013]

11 Available from: http://www.ada.gov/2010ADAstandards [Last accessed on

2011 Aug].

12 Supporting Integrated Design through Interlinked Tools: The Labs21 Toolkit Available from: http://www.labs21century.gov/ [ Last accessed on 2012 Jan 18].

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