Diseño de Laboratorios
Diseño de Laboratorios
Diseño de Laboratorios
MAY 2019
®
Acknowledgments
APHL would like to thank the following for their participation in assembling this Guide:
APHL:
• Scott Becker, MS
• Eric Blank, DrPH
• Palmira Mangae
• Lucy Maryogo-Robinson, MPH
• Deborah Odegbile
• Ralph Timperi, MPH
HDR:
• Rachel Coffee
• Diane Dowgielewicz
• Lou Ann Bunker Hellmich
• Jeffery Minton
• Mike Mottet
• Greg Wells
Other Contributors:
• Paul Jankauskas, MS, MBA, Consultant
• Terry Williams, Washington State Public Health Laboratory
This guide is meant to provide a general overview on some of the core activities included in the lab design process. The
information provided should help laboratory teams walk through the design process and implement the activities that will help
make the laboratory a success - not just in design, but also in operations.
This guide does not address the details and technical requirements behind good laboratory design, nor does it provide
information specific to different lab types. Laboratory teams embarking on a new lab design or lab renovation should
supplement the use of this guide with additional resources—such as local or lab-specific standards—and input and guidance
from appropriate experts.
1.1 Vision
A laboratory’s vision expresses its purpose and reason for being. It provides inspiration and a framework of values that define its
culture, identity and brand. In a sense, a laboratory’s vision is its DNA and its values are the genes that form that vision (DNA).
A laboratory’s vision should express the image and identity the institution wants to portray to the public, to its peers in the
profession and to its own personnel. It should describe desired synergies that address connectivity, collaboration and the team
environment and address values related to cost appropriateness and sustainability. The vision statement looks to the future
of the laboratory and its growth potential (through flexibility and the attraction and retention of staff) and should establish a
standard for the quality of life that the laboratory supports, with respect to its professional environment, opportunities for staff
to thrive and the provision of amenities. Security is also an important issue to address in considering aspects of the laboratory’s
vision.
A visioning session with key laboratory leadership can be a useful tool in developing a vision statement. A variety of tools, such
as value trees and imagery exercises, can be used to facilitate choice, challenge and consensus in identifying the key values of
the laboratory organization. Visioning session outcomes—in the form of implementation outlines—can then be used as the basis
of the laboratory’s mission statement.
1.2 Mission
A laboratory’s mission statement clearly and concisely defines how the lab will achieve its vision. It is a declaration of core
purpose and focus and serves as a filter to separate what is important, from what is not. The mission clearly states which
populations will be served and how and communicates a sense of intended direction to the entire organization.
Deliverables:
• Vision statement document
• Mission statement document
• Existing conditions assessment report
• Problem statement document.
2.1 Programming
The initial programming phase explores and develops the scope of work and functional requirements to meet user needs. Detail
is provided on each laboratory activity that will be performed and estimates of space and equipment requirements are made.
These requirements inform the final space use estimate, providing the basis for further discussion of international best practices
and modular planning, which are key to future flexibility.
The purpose of programming is to provide adequate space to accommodate testing, people and equipment needed to perform
the testing. It also identifies key functional adjacencies, enhances efficiencies to minimize duplication and increases economy of
resources. Each department is interviewed to identify:
• Tests performed
• Microorganisms and chemicals used or likely to be encountered
• Material resources required
• Number of personnel working in the department
• Workflows
• Materials and waste flows
• Utilities needed
• Special requirements that impact the space
• Equipment used.
In the end, this data will be used to develop room data sheets that are reviewed as a check list to ensure all needs are
accounted for in the space program and final design.
Establishing a thorough list of questions to ask is important in understanding future growth needs. Every activity that occurs on-
site, both at the macro scale and the micro scale should be considered. The following are some examples:
• What visitor flow will be generated on site? (e.g., public, professional/scientific, courier, deliveries) What level of security
will be needed?
• How do samples arrive on site? Is a perimeter reception facility required, or do they come directly to the lab building?
• How will waste be handled? (e.g., municipal, private service, on-site)
• What municipal utilities are available? How dependable are they? Will on-site provision of emergency back-up utilities
be needed?
• Are there provisions for employee housing?
• Are there external groups coming to the facility for training? What is the period of time they are on site? How do they
arrive?
• How does the staff get to the facility? (e.g., car, shuttle, public transportation)
• Will there be provision for food? (e.g., on-site, locally available)
• What site or facilities are adjacent and what impact do they have on the facility?
• What available open land areas exist for expansion? Is additional land required?
• What is the volume of materials delivered to the site regularly? Is there a need for central reception or security
screening of materials and storage?
Many times, facility infrastructure is undersized due to a lack of future planning. If future infrastructure expansion needs are
accounted for in a master plan, future growth is much easier to implement and is also much more economical.
The master plan can also be a key tool in financial planning especially for funding phases of expansion. This not only helps in
forecasting annual capital expenditures in institutional budgets, but also when seeking funding from external sources. Many
times the terms master plan and strategic plan are either confused or used interchangeably because of the close relationship
between them. A strategic plan details the data behind the business of operations and growth strategies whereas the master
plan is the road map to realizing the physical reality of that same data.
During the master planning process, different approaches as to how growth can happen will present themselves. These different
strategies are comparatively analyzed for their pros and cons. An effective way to judge the merits of different options is to
create a color-coded value matrix that graphically lists these values side-by-side. This becomes a tool that enables the steering
committee, core team and design team to have an in-depth discussion and come to consensus on what direction the final
master plan should take to satisfy the vision and mission of the laboratory.
This should also include consideration of the expansion of each department’s focus with in its specific scientific area
of expertise (Will it be handling new agents in addition to those currently tested? Or adding new tests or equipment? Or
automation?). This will help to anticipate initial built-in expansion space and future expansion space needs. It is also necessary
for right-sizing staff support areas in the facility. Consideration should also be given to space required for training activities that
occurs in the laboratory areas. How are the internal personnel trained? Are there cooperative programs with other institutions
Deliverables:
• Complete function and space program
• Checklist for lab planning, staffing and equipment list
• Master plan document
• Detailed workforce staffing plan
• Cost estimate
• Outline of key budget considerations.
MASTER
PLAN SCORECARD EXISTING OPTION 1 OPTION 2 OPTION 3 OPTION 4
LAB CAPACITY
LAB FLEXIBILITY
LABORATORY SUPPORT
CAMPUS SUPPORT
CAMPUS OFFICE CAPACITY
CAMPUS INFRASTRUCTURE
CAMPUS AESTHETIC
QUALITY OF OPEN SPACE
Effective management of biorisks is dependent on prioritizing primary and secondary containment measures and strategies to
assure secure operations and efficient allocation of resources. Clear identification of mitigation measures needed to minimize
the risks presented with handling and storage of biohazardous materials is a safer, more secure approach than incorporating
measures based solely on biosafety level or a prescribed solution approach.
The biosafety and biosecurity risk assessment report is a key tool for the design team (i.e., steering committee, core team and
external design team) as they seek to reach consensus on appropriate mitigation measures to address identified risks. Design
team members also benefit from research on containment requirements, review of benchmark facilities and consultation with
biosafety experts to better understand the risks associated with the agents being used in the laboratory.
Additionally, understanding common terminology in reference to laboratories and the processes that take place in the lab
building is paramount to being able to understand and apply lab planning and design principles.
Beyond codes and terminology, understanding the fundamentals of laboratory design and planning concepts will help minimize
the risks associated with laboratory work by creating safe environments to work in. However, it’s important to remember that a
good laboratory design will not substitute for good laboratory operations and practice. Ideally, the two should work together to
create a favorable environment.
The lab planning and design fundamentals include planning concepts, safety concepts and program components, adjacencies
and workflow.
Both active and passive measures are used to achieve biosafety and biosecurity. Active measures are task-related and can
include executing protocols and SOPs, sample management, inventory systems and security response. Passive measures are
related to features of the design, equipment, or systems that have been incorporated into the building, such as access controls,
CATV monitoring systems, personnel management systems, HEPA filtration, exclusion zones, perimeter walls, guard houses and
wheel washes.
This risk assessment report in section 5.1 is the best tool to help develop appropriate biosafety and biosecurity responses.
References
Building Codes:
• 2012 International Building Code
• 2012 International Mechanical Code
• 2012 International Plumbing Code
• 2012 International Electrical Code
• 2012 International Fuel Gas Code.
National Research Council: Prudent Practices in the Laboratory: Handling and Disposal of Chemicals, National Academy Press,
1993
United States Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of
Health: Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th ed. 2007
United States Department of Labor, Occupational Safety and Health Administration: Occupational Exposure to Hazardous
Chemicals in Laboratories, Code of Federal Regulations: 29 CFR, Ch. XVII., 1910.1450
The risk assessment report identifies the complexity and risks of agents to be handled during testing, (e.g., TB, Flu, E. coli, Ebola-
PPE) and provides guidance on appropriate means of risk mitigation and agent disposal—whether on-site or off-site, or by use
of autoclave or incineration. The report may also identify systems, such as IT infrastructure, that could be vulnerable to outside
interference or access and what measures are needed to prevent access. Internal protection of data systems and intellectual
property should be carefully evaluated.
Power and water utility systems should also be considered in the risk assessment. If power outages are common, an estimate
of required back-up power generation or needed emergency water storage capacity can be made based on historical data. All
utilities crucial to operations should be evaluated.
Requirements pertaining to MEP systems are important as they relate to the structure and future space needs. Consideration is
needed to provide a sustainable approach to systems design.
Predesign activities (i.e., visioning, mission statement, assessments, programming, master planning, staff planning, budgeting,
risk-based design decisions and assessments, protocol mapping, functional requirements, SOPS, inventory) produce data that
form the basis of laboratory functions such as tests,
equipment, chemicals, flows and adjacencies.
These activities become the raw materials used by DESIGN PROCESS
the design team to identify what lab user groups
want and need—and form the building blocks used CONCEPTUAL SCHEMATIC DESIGN
to create conceptual design options (i.e., layouts, DESIGN DESIGN DEVELOPMENT
PHASE PHASE PHASE
diagrams, plans, elevations).
The final design development documents are used create the cost estimate issued in the BOD document. The cost estimate
(Total Project Cost) includes but is not limited to Hard Costs (all construction materials and labor costs, land cost, utility
costs, site development costs, infrastructure costs) and soft costs (constructor overhead and profit, construction contingency,
insurance, A/E fees, furniture and equipment costs).
It gives an understanding of how and why the project design meets the mission through sections that outline historical data and
operational information needed to explain the logic of the design.
It is very important that the laboratory achieve buy-in from key health ministry decision-makers prior to the start of detailed
design (see Section 5 – Advancing Concept Development) in order to advance the design for the facility improvements. Ideally,
the buy-in would be in place from ministry leadership and laboratory staff; thereby, providing good momentum in moving the
project forward.
Deliverables:
• Project charter with attached business case
References
• Example Project Charter document
• Example Business Case document
Every country has their own specific procurement process for selecting architects and contractors for a new facility. However, it is
important for laboratory leadership to be familiar with international best practices for the design and construction of a complex
laboratory facility to ensure that the resulting building incorporates the performance criteria previously discussed.
Another strategy to assure that architects and constructors are qualified to work on a laboratory building is to call references
from previous projects and verify how they performed.
Touring previous projects will also provide insight into the quality of the finished building.
In the best value strategy, the best overall team is selected, taking into consideration both qualifications and price. Even if a
firm’s price is higher than a competitor’s, they may be the most qualified and have the best people with the right experience and
consequently represent the best value. Utilizing the best value selection strategy allows each criterion to be weighed separately,
as well as collectively.
While qualifications, price and best value should all be considered, the most important factor in the selection process is to
ensure that representatives from the laboratory are voting members of the selection committee. A laboratory facility is very
complex and contains many specific technical and flow-related processes that need to be understood during design. Having
laboratory personnel as part of the selection committee adds crucial subject matter expertise to the process.
M E T H O D O LO GY C O N T R ACT C O N ST R U CT I O N C O ST Q UA LI T Y SCHEDULE
MEDIUM RISK HIGH RISK LO W R I S K MEDIUM RISK
Owner holds a The cost of the project Since the architect The schedule is
Design Bid separate contract with is estimated during works for the owner, estimated during design
Build the architect and the design, and the actual the drawings reflect the and is subject to some
constructor. costs are not known needs of the project. change during bidding.
until bidding.
HIGH RISK MEDIUM RISK MEDIUM RISK LO W R I S K
Owner holds a contract The CMaR issues The project is procured One of the advantages
Construction with the architect, drawings to be bid by in phases to speed of CMaR is the speed of
Manager at constructor, and the contractors, in multiple construction, which the schedule because
Risk (CMaR) CMaR. The CMaR acts phases to speed can negatively impact construction is started
as the owner’s agent. construction, which can quality. prior to final design.
add cost.
MEDIUM RISK LO W R I S K HIGH RISK LO W R I S K
The owner holds Cost is known very early Since the selection is There are usually
Design Build one contract with as contractors respond generally based on incentives for the
(DB) the constructor. The to an RFP (tender). price, the overall quality constructor to finish the
architect works for the of the project can be project early.
constructor. lessened.
One of the most overlooked but important services to include, as part of a laboratory construction project team, is the
commissioning agent (Cx). The Cx will be most effective for the project when engaged early in the design process, through move-
in. The Cx will be familiar with the Standard Operation Procedures (SOP) established by the laboratory for testing and assure that
the building’s performance criteria are installed to perform in concert with the SOP.
For most buildings, the constructor is responsible for buying and installing products and materials consistent with the
performance criteria in the Basis of Design and for assuring that air handlers, generators and other constructor- installed
equipment operate correctly under normal conditions. The Cx, however, is charged with developing criteria and scenarios to
simulate real life situations that could cause an outage, or planned or unplanned system failures. As a result, we can assure that
the equipment not only runs, but that systems will all work together in different failure and maintenance scenarios.
Deliverables:
• Commissioning Check List
• Commissioning SOW
References
Construction Process Workshop
That is why it is important for members of the laboratory design team to review the final design documents for conformance
to the BOD. This is essentially the last chance to
correct any discrepancies prior to construction. Any PROJECT TIMELINE
changes that need to be made after construction
begins what are referred to as “Change Orders.” And COST OF DECISION
Given that the construction process is very complex and substitutions frequently occur, in the case of a sophisticated test
laboratory it is crucial that any “Request for Substitution” from the in-country architect be reviewed by the laboratory design
team for conformance to the BOD.
From this point forward to project completion, changes requested by the laboratory owner are considered a change to the
constructor contract. Furthermore, any change, even if deemed necessary, will likely impact the overall schedule and budget of
the project.
Deliverables
• Final Documents for Construction
• Final Product Specifications
• Final Construction Budget
References
Construction Process Workshop
There are several important reasons why regularly scheduled visits to a facility under construction should be planned. Site visits:
• Increase familiarity with the new space. The layout for the new space will likely be quite different from the existing
layout. Staff can become familiar with the general layout of the new laboratory space by walking the halls.
• Affords a look at systems being installed above ceilings and behind walls. This is valuable information that could be
useful later, during move-in. It may also be an opportunity to observe elements that are inconsistent with the BOD and
can be reported to the in-country design team.
Visits are great for morale. Having been a part of creating the space list, the BOD and the flows and adjacencies, walking the lab
allows the staff to take pride in what they helped create.
9.2 Commissioning
Members of the laboratory design committee should participate in aspects of commissioning and review the commissioning
reports to ensure that installed systems perform as planned. Commissioning is a quality-focused process to verify and document
that a facility and its systems are planned, designed, installed, tested, operated and maintained to meet the Owner’s project
requirements. The major benefits of commissioning are:
• Providing a focused process for turnover and acceptance
• Validation of successful operation
• Building energy systems that perform as needed
• Proof of system performance
Commissioning is the process from initial planning through initial operation that addresses how the project team will install,
energize, test, validate performance and hand over with the appropriate documentation and training.
There are five steps to commissioning a building that should be followed to achieve the best results:
• Pre-construction
• Construction
• Acceptance
• Hand-over
• Occupancy
ADVANCE PREP
Advance prep should start a year out from the move, according to those who have been there. What do you spend that year
doing? The top priorities:
• Ensuring funding
• Enlisting movers
• Preparing staff and clients
• Verifying contracts
• Notifying regulatory agencies
• Reducing inventories
• Minimizing the number of things you need to move
ON THE MOVE
With a laboratory move, smooth and consistent progress and right-on-time accuracy isn’t just convenient and cost effective.
It’s critical for safety and maintenance of urgently needed services. A few of the key considerations outlined in APHL’s Practical
Guide to Moving to a New Site for Public Health Laboratories:
• Move in stages
• Set up redundant testing sites
• Coordinate maintenance at the old and new site during transition
• Time the purchase of new equipment
• Decontaminate the old lab
SETTLING IN
The move isn’t over once you get into the new facility. In fact, it can take up to a year to “shake down” the new space. Some
suggestions:
• Test air handling systems before moving
• Coordinate with IT
• Check warranties
• Get staff comfortable with the new space
• Prepare to give lots of tours of the new lab
Deliverables
• Commissioning checklist
• Move checklist
References
APHL – A Practical Guide to Moving to a New Site for Public Health Laboratories
• People—The public health laboratory should certainly consider the various working environments needed for the staff,
as well as visitors to the laboratory. People working in or visiting the laboratory will require office furniture, laboratory
furniture, lockers and conferencing equipment.
• Equipment—Analytical testing equipment is a core need of the public health testing laboratory, but there is also a
need for specialty equipment to support laboratory operations, such as Biological Safety Cabinets (BSCs), Chemical
Fume Hoods (CFH), autoclaves, glassware washers, glassware dryers and incinerators. The building itself may contain
equipment, as well, including elevators that will need to operate daily.
• Building Systems—There are building systems that need to operate 24/7 to support the testing and training performed
within the lab. These items could require attention on a daily basis as weather conditions have an impact on the
systems. Day-to-day operations should consider performance and budgeting for:
1. Architectural items
a. Laboratory casework
b. Doors and windows
c. Flooring
3. Electrical
a. Normal power
b. Emergency power
c. Lighting
4. Plumbing
a. Water
b. Fixture (sinks and toilets)
c. Drainage
5. Fire protection
a. Alarms
b. Sprinkler systems
c. Extinguishers
6. Cleaning
a. Building cleaning
b. Decontamination
7. Security
a. Security personnel
b. Security systems
8. Site
a. Roads
b. Grounds
c. Storm water
d. Lighting
MAINTENANCE
There are three levels of maintenance to consider in budgeting for a new laboratory facility.
• Predictive (routine)—Items that require daily or weekly maintenance based on usage or need (e.g., refilling the hand
towels in the toilets).
• Preventative (on-going)—Maintenance tasks that can be scheduled based on usage (e.g., changing the oil in the
emergency generator, in accordance with the manufacturer’s recommended maintenance requirements).
• Reactive (emergency)—Issues that are unforeseen or out of sequence and require immediate attention to prevent future
damage or to maintain continuity of operations (e.g., a water pipe burst must be repaired immediately to prevent further
damage).
“An appropriate annual budget allocation for routine M&R (i.e., maintenance and repair), in a substantial inventory of facilities,
will typically be in the range of two to four percent of the aggregate current replacement value (CRV) of those facilities (excluding
land and major associated infrastructure). In the absence of specific information upon which to base the M&R budget, this
funding level should be used as an absolute minimum value. Where neglect of maintenance has caused a backlog of needed
repairs to accumulate, spending must exceed this minimum level until the backlog has been eliminated.”
Federal agencies currently use two different methods of determining CRV (which some agencies call the current plant value):
1. The current unit construction costs (e.g., dollars per square feet) for various types of facilities in an agency’s inventory
are multiplied by the total number of units (e.g., square feet) of each type of facility in the inventory. In making the
calculation, it is essential that the units of area used are the same as the units in the assumed unit costs. Major errors
can be introduced, for example, if unit costs based on gross area are multiplied by net or occupiable areas.
2. The original total cost of each facility in an agency’s inventory is multiplied by an escalation factor (based, for example,
on the Engineering News Record’s building cost index) to determine the cost of the facility.
Either method will give current replacement values that are sufficiently accurate for M&R budgeting purposes. However, the
committee believes that in most cases, the first approach is easier to use.
A good way to assure that a building can be easily maintained is to use locally-sourced materials and supplies. This will increase
the likelihood of availability without additional shipping expense and ensure familiarity with the products as they are typically
used by others in the area. For a laboratory facility; however, this can be challenging as some items such as fume hoods may
need to be shipped from other countries.
1. Dedicated personnel—Monitoring the facility on a daily basis requires staff who are familiar with the numerous systems,
equipment and people using the lab. A dedicated facilities management team can respond to lab demands and ensure
that testing will continue every day.
2. Training—Facility management staff need to be trained in all aspects of the building to facilitate appropriate
performance. Just like the lab staff, facilities personnel need to learn new trends, techniques and tricks to maintain and
operate the building systems efficiently and productively.
3. Maintenance contracts—Effective use of maintenance contracts can improve long-term control of maintenance costs
and prolong the life of many systems in the laboratory. The prudent use of maintenance contracts can also reduce
personnel costs by contracting-out routine or very specialized services.
Deliverables
• Facilities Management tools
• O&M Budget
REFERENCE SECTION
www.nap.edu/read/9226/chapter/1
Implementation
Engineer Selection
Establish Selection Committee
Establish Bidding Process
Design
Documentation of Functional Requirements
Safety Protocol Support
Workflow
Budget
This project was 100% funded with federal funds from two federal programs of $3,008,606 and $12,889,006. This publication was supported
by Cooperative Agreement number # NU60OE000103 and by the Cooperative Agreement # NU2GGH001993, both funded by the Centers for
Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of
the Centers for Disease Control and Prevention or the Department of Health and Human Services.