Documentation and Record Management
This module defines methods of documentation as defined in the ISO 15189:2012, ISO 9001 and CLSI guidelines. This manual has been prepared for use in the Training for the Labs for Life programme to:
a) Understand the need for documentation and explain the important steps, or elements, of a laboratory document management system, the good documentation practices as defined under standard guidelines, document identifiers , document hierarchy in QMS and the role of each level & how to write Quality Policy
b) Learn how to implement a document control system
c) Outline the contents of a Quality Manual, Quality System Procedures, Standard Operating Procedure
d) Describe methods and tools to properly store documents and records
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Sample Collection and Pre-analytical Best Practices
This module has been prepared for the training in best practices for sample collection, receipt, processing, packaging transportation and safe disposal of biological samples.
The module will help:a) To understand the best practices as defined under the standard guidelines, guidelines for correct specimen referral, transportation and storage for accurate test results, safe disposal, bio-medical waste management and the responsibility of management and technical departments in pre-analytical processes. b) To identify the non-conforming events with regard to specimen integrity and associated patient and health care worker safety. c) To educate and promote safe practices and reduce blood-borne pathogen exposure and transmission. d) To improve patient confidence and comfort and to avoid and manage associated complications and the quality of laboratory test results by assuring specimen integrity.
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Facility Management and Safety
This module has been laboriously created to understand the essential elements of laboratory facility management and safety and to prevent and control exposure to laboratory hazards.
This module has been developed for guiding labs to:
a) Evaluate their laboratory layout for efficiency, optimal workflow, comfort, privacy, adequate storage space, safety and emergency systems
b) Organize their laboratory space such that tasks can be performed without compromising quality of work, safety of personnel, patients, and the community
c) Understand the essential elements for laboratory facility management and safety and prevent and control exposure to laboratory hazards
d) To actively participate in the design and planning stages of new laboratory; facilities
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Equipment Management
Equipment management is an integral and critical aspect of quality management system of a clinical laboratory. This important facet of quality lab management has been somewhat neglected thus far and is now being increasingly recognized that adequate and timely management of lab equipment is an essential prerequisite for accurate and quality testing.
The module has been developed to guiding the labs to:
a) Understand standard practices in procurement, installation, acceptance testing, maintenance, troubleshooting, repair and retirement of equipment
b) Understand the working of key lab equipment used in public health system in India.
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MCI Standards
Minimum Standard Requirements for the Medical College for 100 Admissions Annually, Regulations, 1999
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