Student Dissertation

Agency : Satellite Labs; Standard Procedures; Standard Manual; Quality Assurance

Objective : ï‚· To set a standard manual of technical requirements in a satellite laboratory. ï‚· To study and compare the existing process with the standard manual in a satellite laboratory and recommend process improvement.

Background : The Healthcare Technology and Healthcare industry is evolving rapidly with the growing requirements of the patients Apollo Health and Lifestyle Limited, India’s first name in corporate healthcare, ‘good health for all’ is the abiding focus. To expand the offering and increase its accessibility to a wider network of patients and doctors, Apollo diagnostics has launched satellite laboratory. Satellite laboratories are located in tier II and tier III cities. There are particular guidelines and standards that should be followed by every medical laboratory. The International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements that are necessary for a laboratory to meets both the technical competence and the management system to consistently deliver valid results.

Methodology : There will be two sets of data which will be generated during the course of the study:  First set of data would be based on the review of existing laboratory documents and telephonic as well as face to face interviewing of the employees.  Second set of the data will be based on the standards established in NABL guidelines and ISO 15189 2012 for medical laboratories The motive of the study will be to analyse the gaps and redesign the manual that fills the gap for a laboratory to consistently deliver technically valid results.

Findings : 1. Technical manual was not present in the labs due to which many important documents were not registered in the labs 2. Interpretations were not present in the report format. 3. Training of the laboratory technicians were not a part of induction module.

Recommendations : 1. All the documents including quality manuals, fire safety manual, personal safety manual, SOPs in the laboratory should be available in both hard and soft copy in every laboratory. 2. Basic Life supporting training for laboratory technicians. 3. Technical manual should be included along with all important laboratory documents.