Planning & Designing of Clinical Laboratory

WHAT IS AN IDEAL LABORATORY?

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An Ideal Medical Laboratory is a set up which is functional, adaptable, expandable, efficient and most importantly safe for all users. The process of lab designing is a complex one. Ideally the focus should be on functionality with uncompromising quality, health & safety, convenience and energy conservation. In Lab establishment, whether a new construction, expansion, or a renovation project, it is not only simple to buy the reasonable equipment with allowable room for adaptation to accommodate future technological advances, but it is also a judicious use of available budget. A comprehensive consideration of the overall planning of lab, rational layout, and graphic design, as well as economic and eco friendly use of electricity, air and water, and due consideration to ventilation, air purification, effluent treatment, safety, environmental protection, infrastructure and basic conditions is of paramount importance.

PLANNING AND DESIGNING

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Fundamental to the process of diagnostic facility planning is an understanding of basic design principles that ensure future adaptability to the technological advances. Laboratories must have the flexibility to accommodate, as-yet-unknown changes in technology and scientific processes. Modular design is by no means a cookie-cutter approach but rather a simplified approach to achieving a wide range of goals in laboratory design. Medical laboratories vary in size and complexity and to offer a variety of testing services. More comprehensive services can be found in acute-care hospitals and medical centers, where more than 70% of the clinical decisions are based on the lab findings.

THE BASICS OF LABORATORYDESIGN AND DEVELOPMENT

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As mentioned earlier, a new model of clinical lab design is emerging, one that creates lab environments that are responsive to present needs and capable of accommodating future demands. The first step in the design process is to understand the purpose of the set up. A lab designed for typical commercial analysis of samples can be far different from a laboratory designed for meeting the needs of a process quality control lab, or an analytical research lab.

The foundation for setting up a good lab lies upon the precise planning of five main stream services. Those are

1. Civil interiors,

2. Electrical,

3. HVAC (Heating, ventilation, and air conditioning),

4. Utility services

5. Safety aspects.

Over and above the utmost focus has to be on maintaining the HSE (Heath, Safety & Environment) standards.

In hospitals and other patient-care settings, laboratory medicine Department is generally divided into following sections

1. Biochemistry

2. Hematology and Immunohematology

3. Clinical Pathology

4. Microbiology and Serology

5. Histopathology

6. Cytopathology

7. Molecular Biology

CLASSIFICATION OF MEDICAL LABORATORY

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The Clinical Laboratory can be classified based on the number of patients treated on daily basis.

Small Laboratory: A laboratory receiving up to 100 patients per day

Medium Laboratory: A laboratory receiving up to 101-400patients per day

Large Laboratory: A laboratory receiving above 400 patients per day

PLANNING PREMISES AND DESIGN CONSIDERATIONS

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The Lab Unit will consist of the following Functional Areas

1. Entry/ Reception with patient waiting area with toilet facility

2. Specimen collection area (depending on set up) including patient toilets; with all required amenities.

3. Specimen Accessioning

4. Core Laboratories

5. Support areas, (eg. reagents and sample storage etc)

6. Staff Areas (eg. Offices Lockers etc)

HOW QUALITYKONNECT WILL HELP YOU..

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WE ARE WITH YOU FROM 'CONCEPTION TO'REALIZATION'

PLANNING AND DESIGNING

1. Detailed Project Report (DPR) including Technical Feasibility Study and Project Conceptualization

2. Facility Design and Interiors

3. Concept Design (Line diagram with equipment positioning) as per International Standard

4. Medico Technical guidance on Turn Key Drawing (Civil, MEP, HVAC,MGPS & Interiors)

5. Periodic Site Supervision to ensure Construction is done adhering to technical inputs

EQUIPMENT SUPPORT

1. Providing detailed guidelines and technical specifications of equipment & other consumables

2. Recommendations & Negotiation with vendors

3. Support during Installation Qualifications, Operational Qualifications and Performance Qualification of Equipment

4. Calibration Support

MANPOWER SUPPORT

1. Strategic recruitment support

2. Build staff hierarchy that works in the best interest of your organization.

DOCUMENTATION

1. Preparing and providing various level of Documentation required for International Accreditation, like Quality Manual, Quality Management System Procedures(QMSP), Standard Operating Procedures (SOP), Files, Formats for daily maintaining, registers.

2. Staff training on documentation and its maintenance.

STAFF TRAINING

1. Preparing Training module for staff

2. Conducting various training programmes

WORK FLOW ESTABLISHMENT

1. Reporting guidelines

2. Establishment of TAT (Turn Around time)

3. Staff schedules and rosters

ACCREDITATIONS

1. GAP Analysis report of entire Organization as per International guidelines.

2. Training of staffs on standards.

3. Formation of Core Quality Team and guiding them through implementing accreditation standards throughout the organization.

4. Formation of various Committees .

5. Conducting Internal Audits.

6. Statutory Compliance Guidelines.

7. Providing guidelines for various displays.

8. Implementing policies for capturing Quality Indicators.

9. Filling Application processes.

10. Conducting Mock Drills.

11. Risk Assessments.

12. Entire assessment support including facing assessment, taking proper corrective & preventive actions against assessor's observations.

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