Procedure for Selection & Procurement of Equipment:

• Selection & Procurements will be done within limits of Government of Gujarat rules and regulations.
• Required Equipment can be purchased through Parent institutes that are Sir T Hospital, Bhavnagar and Government Medical College Bhavnagar.
• If any equipment is to be purchased, prepare its specifications, send demand & specifications to the Dean(Procurement from Medical College) or Medical Superintendent(Procurement from Sir T Hospital).
• Communicate the requirement with specification to the parent institute.
• The parent institute can purchase it by plotting a tender.
• Select and approve suppliers based on the laboratory's requirements & Specifications. This process is called Technical Scrutiny.
• Send the list of selected and approved suppliers of equipment at the office of the parent institute.
• Ask the parent institute to procure the equipment from the finalized supplier.

Procedure for Installation & Acceptance testing

• When the equipment arrives in the laboratory verify that equipment specifications and other conditions required from suppliers are acceptable.
• If above conditions are not met,return the equipment to the supplier as per rules and regulations.
• If above conditions are met, enter equipment details into the equipment stock register & give indent of received equipment to the central store department.
• After Installation of equipment Installation qualifications, Performance qualifications & Operational qualifications should be checked by using traceable reference material.
• Run quality control materials, to find whether the performance of equipment is appropriate to the need or not.

Acceptability Criteria:

• Validation of Equipment will be done as per applied specifications & Verification data will be checked and recorded.

Procedure for Handling, Transport, Storage:

• as per manufacturer's instructions

Procedure for use and maintenance:

• Arrange for training of all personnel who are likely to use it for examination of patient samples.
• Store manufacturers instructions in electronic format and communicate with users, so that they are available to everybody whenever required.
• Prepare instructions for use of equipment and required standard operative procedure and communicate with users and store preferably in the google drive & dokuwiki documentation system of the laboratory.
• Perform preventive maintenance as per manufacturer’s instructions.
• Whenever equipment is found to be defective mark it 'Not working' till it is appropriately repaired.
• If any breakdown occurs in any equipment, it will be corrected either by lab person or company person and will be recorded in the NC record.
• Write Non-Conformities Scenario, root cause, immediate action, corrective action & risk management in this register.
• Periodically Review NC records to find out common causes and possible corrective actions can be taken to decrease breakdown and malfunctions.
• Once repaired, Calibrate, if required, and use it for performing examinations for which it is required, using quality control materials, to find whether the performance of equipment is appropriate to the need or not.
• If any adverse incidents and accidents occur that can be attributed directly to specific equipment, follow Procedure for identification, control, correction and prevention of nonconformities and report to the manufacturer and appropriate authorities.
• Preventive maintenance will be performed as per manufacturer's instructions.

Procedure for disposal:

• If equipment is not working, condemnation will be done after verification by the biomedical engineer.