Checklist Equipment

Does the laboratory have a clear register of all the equipment present?

Activity

Does the equipment register contain the following details for each piece of equipment? (tick off)

  • Identity
  • Label
  • Serial number
  • Manufacturer name
  • Manufacturer’s contact person and contact details
  • Service provider name
  • Service provider’s contact person and contact details
  • Date of purchase
  • Date of putting into service
  • Location
  • Condition
  • Frequency of maintenance
  • Date of previous maintenance
  • Date of next scheduled maintenance
  • Remarks

Activity

Is all critical equipment functional?

Activity

Has the laboratory identified critical needs for specific pieces of equipment that must be present in order for the piece of equipment to function?

Activity

Does the laboratory have a standardized, documented procedure for procurement and reception of new equipment?

Activity

Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment?

Activity

Is the SOP for Procurement and Reception of Equipment stored at a logical location, accessible to all staff members?

Activity

Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members?

Activity

Is the SOP for Procurement and Reception of Equipment demonstrably authorized by laboratory management?

Activity

Are all technical and managerial staff members aware of the existence of the SOP for Procurement and Reception of Equipment and do they know when to use it?

Activity

Have all pieces of equipment that have a direct influence on the outcome of examinations been validated?

Activity

Are all findings of validations (both validation of examination methods and validation of equipment) documented in validation reports?

Activity

Are SOPs present for all pieces of equipment?

Activity

Are Equipment SOPs written in accordance with the procedure described in the Master SOP?

Activity

Are Equipment SOPs stored at a logical location (near the equipment they have been written for), accessible to all staff members?

Activity

Have staff members demonstrably read the SOPs that are relevant for them?

Activity

Has all equipment in the laboratory been labeled?

Activity

Do the equipment labels include the following data:

  • Equipment code
  • Date of last service/calibration
  • Date of next service/calibration

Activity

Are the equipment labels resistant to fluids, chemicals, light, and other daily factors causing wear and tear of the labels?

Activity

Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing after a piece of equipment has been discovered to be defective?

Activity

Is the procedure for determining and correcting the negative influence of defective equipment documented in an SOP?

Activity

Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective?

Ask the interviewee to show an example.

Activity

Is it documented who is responsible for each piece of equipment and who is authorized to use the equipment?

Activity

Do staff members who are responsible for a piece of equipment know their responsibilities?

Take a sample by asking such a staff member.

Activity

Are staff members authorized for use of a piece of equipment properly instructed/trained?

Activity

Does the laboratory have a Maintenance Log Sheet for each piece of equipment that shows what maintenance has been performed at which moment to which piece of equipment?

Activity

Does the laboratory use log sheets to record usage of specific pieces of equipment where necessary?

Activity

Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment?

Activity

Are the Usage Log Sheets placed near the piece of equipment they have been developed for?

Activity

Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive?

Activity

Does the laboratory have an Equipment Archive that contains all the documents and records needed for each piece of equipment as listed in ISO 15189:2007 article 5.3.4 or ISO 15189:2012 article 5.3.1.7?

Activity

Does the laboratory have a documented procedure that describes the following:

  • Activities that need to be undertaken when new equipment is introduced in the laboratory
  • The required measures for ensuring maintenance and calibration of the piece of equipment
  • Ensuring presence of the SOP for maintenance and use of the piece of equipment

Activity

Are Bench Aids used for various pieces of equipment?

Activity

Are these Bench Aids in accordance with the currently authorized versions of SOPs for equipment?

Activity

Is the method of maintenance and calibration of equipment documented?

Activity

Is the budget needed for the maintenance and calibration of equipment calculated and documented?

Activity

Have funds been identified for annual maintenance and calibration of equipment?

Activity

Have funds been identified for training of a staff member for internal maintenance and calibration of equipment?

Activity

Is a preventive maintenance program in place for all pieces of equipment?

Activity

Does the laboratory demonstrably adhere to this program?

Compare maintenance records for a piece of equipment from the equipment file with the dates this maintenance was planned in the Equipment Maintenance Schedule.

Activity

Is the procedure for ensuring equipment maintenance standardized in an SOP?

Activity

Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”?

Activity

Does the laboratory have an SOP explaining the procedure to be followed for ensuring validation of equipment when it is returned into service after repair?

Activity