This document discusses the organization and design of diagnostic laboratories. It begins by introducing the importance of laboratory design and organization. Key documents like organizational charts and procedure manuals describe how personnel, equipment, and facilities are integrated. The document then discusses four major changes in laboratory design: 1) Open-plan designs for flexibility, 2) Increased automation testing, 3) Incorporation of biosafety level 3 containment, and 4) Growth of molecular testing. Ten steps for an efficient laboratory layout are also outlined. The document concludes that well-designed laboratories provide flexibility for future growth and ability to incorporate new technologies.

1. Name : R.Harish kumar
Roll no :18UT31
Class : lll B.Sc biotech
TOPIC : BASIC DESIGN AND ORGANISATION OF DIAGNOSTIC
LABORATORY
SUBJECT : PHARMACEUTICAL MARKETING

2. INTRODUCTION
 Clinical laboratories are among the most important spaces hospitals
and related health care facilities may operate, their functional designs
are sometimes less noticed than those of higher profile areas.
 The organization or systematization of the laboratory is enshrined in
several documents: The Organizational Chart, The Policy Manual(s)
and the Procedure Manuals
 These documents describe the integration of personnel, equipment,
supplies and facilities for efficient and effective laboratory operation

4. Four major changes
1.Open-plan designs
• Many hospital labs are now struggling with the physical layout of their spaces.
• With the open plan or big room concept, a lab is built with no interior walls to
allow the layout to be reconfigured as necessary.
• Open-plan labs help to facilitate the implementation and continued operational
goals of Lean design.
• Open-plan lab design and movable casework are also useful for new
instrument validation.
• Likewise, Northern Colorado Medical Center (NCMC) in Greeley, part of the
Phoenix-based Banner Health system, opened a new 14,495-sq. ft. open-plan lab.
• For instance, the lab at Huntsville (Ala.) Hospital, which opened last fall,
covers 30,800 sq. ft. over two floors.

6. 2.Automated tetesting
 is facilitated by open-plan lab design.
 Automated systems may involve 50 to 60 feet of linear track bolted to the floor.
 The automation line functions as the backbone of the lab.
 In addition, the front end, or pre-analytic, section of the line should be placed as
close as possible to where specimens come into the lab.
 Most automated lab systems are scalable, they function well in labs with open-plan
designs.
 A lab can start, for example, with two chemistry analyzers; in a few years, the lab
could easily extend the line to include a third analyzer or the lab could replace an
analyzer with one that can perform a higher number of tests per hour. The open-
plan design allows for modular growth.
 NCMC opened its new lab last year, the hospital went from stand-alone analyzers
to a full-blown automated line.

8. 3.Biosafety Level 3
 Lab design is also being affected by a resurgence in BSL-3 containment.
 Today, with increased concern about infectious disease outbreaks , even small
community hospitals are becoming interested in providing this level of protection in the
lab to ensure safe handling of specimens, even if only to send them out for further
testing.
 McKee Medical Center, Loveland, Colo., also a member of Banner Health, recently
installed a small BSL-3 lab.
 This includes nonporous materials, so pathogens cannot get into the plywood
substrate of a countertop and multiply. Hardened epoxy-coated or protected walls are
necessary . The architecture and mechanical and plumbing systems have to be
designed appropriately to ensure safety.

10. 4.Molecular testing
 Molecular testing is an essential component of personalized medicine, which
is based on a patient’s individual genetic makeup.
 Molecular testing also can be used to identify cancer markers in tissue
samples.
 Pharmacogenomics is another promising area for molecular testing.
 Specimens are amplified during the process so that certain genes or portions
of DNA that normally occur in small numbers are multiplied up to tens of
millions of times.
 For example, It’s not necessary to incubate a specimen for a lengthy period.
Directly testing a blood sample for DNA markers from specific organisms can
produce results in an afternoon, rather than overnight or over several days.

12. Ten steps to an efficient layout
 1. Project development
 2. Team development
 3. Due diligence
 4. Analysis and program development
 5. Process and schematic design
 6. Communication
 7. Process experimentation and detailed design development
 8. Bidding and cost estimation
 9. Permitting and regulatory approval
 10. Design modifications and construction

13. Long-term success
 Well-designed clinical labs provide ample space for maximum flexibility
to enable labs to grow, change and adapt into the future.
 They also provide the infrastructure and layout needed to take
advantage of the latest developments in technology and medicine.
 Sufficient power and data, robust heating and ventilation, careful
design of engineering systems and the selection of appropriate
materials and finishes are critical to the long-term success of clinical
labs.

14. Thank you