Equipment

1. Equipment Ralph Timperi, MPH Massachusetts State Laboratory Institute CDC/APHL Laboratory Team Key Message (Scripted Notes):Key Message (Scripted Notes):

2. The Quality System

3. Proper Maintenance of Equipment is Vital Produce reliable test results Minimize instrument breakdown Lower repair costs Prevent delays in reporting test results Maintain productivity Minimizing instrument breakdown that slows down the work, and reduce the number of costly services for instrument repair, through appropriate planning for maintenance and repair (Creates basis for improving selection and purchase policy) Reliable results aids clinical diagnosis. Unreliable results may result in incorrect diagnosis and treatment of the patient. If equipment is properly maintained, it is less likely to breakdown before its next service and is less likely to perform inadequately as a result of lack of maintenance.Minimizing instrument breakdown that slows down the work, and reduce the number of costly services for instrument repair, through appropriate planning for maintenance and repair (Creates basis for improving selection and purchase policy) Reliable results aids clinical diagnosis. Unreliable results may result in incorrect diagnosis and treatment of the patient. If equipment is properly maintained, it is less likely to breakdown before its next service and is less likely to perform inadequately as a result of lack of maintenance.

4. A Good Equipment Program Improves customer satisfaction Improves the technologist’s knowledge and adds to their confidence A good equipment program plays an important role in the quality assurance of a laboratory to be able to produce reliable results.A good equipment program plays an important role in the quality assurance of a laboratory to be able to produce reliable results.

5. Equipment Management Described in documents (policy, procedures and SOPs) and activities documented in records Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition It is increasingly recognized that equipment management goes far beyond that of a person simply being able to operate the equipment. See list above. Equipment management also requires a specific person designated to deal with all aspects of equipment management. A Selection Criteria Check List will assist in purchasing the most appropriate piece of equipment to meet the laboratories needs, e.g. Cost, Manufacturer and Support, Availability, Model, It is increasingly recognized that equipment management goes far beyond that of a person simply being able to operate the equipment. See list above. Equipment management also requires a specific person designated to deal with all aspects of equipment management. A Selection Criteria Check List will assist in purchasing the most appropriate piece of equipment to meet the laboratories needs, e.g. Cost, Manufacturer and Support, Availability, Model,

6. Equipment Management Oversight Assign responsibilities for all activities Train all personnel on equipment management requirements and responsibilities Monitor equipment management activities by Routinely review all records Ensure all procedures are followed Update policy and procedures, when necessary Training of laboratorians and monitoring of equipment are also important roles of the equipment manager.Training of laboratorians and monitoring of equipment are also important roles of the equipment manager.

7. Equipment Management

8. Selection Criteria Define use, match equipment with service provided, e.g., analyte to be measured, test volume Performance characteristics (detection, throughput) Facility requirements (electrical, HVAC) Cost (purchase, maintenance, reagent, replacement) Supply of reagents (sources, availability) Ease of operation (training, fatigue, errors) Performance characteristics accuracy precision sensitivity specificity Physical requirements electrical, re-wiring, drains, plumbing Supply of reagents Access to reagents Alternative sources Full support from manufacturers in terms of training, installation, service and repair are key points when checking the selection criteria.Performance characteristics accuracy precision sensitivity specificity Physical requirements electrical, re-wiring, drains, plumbing Supply of reagents Access to reagents Alternative sources Full support from manufacturers in terms of training, installation, service and repair are key points when checking the selection criteria.

9. Selection Criteria Warranty Availability of manufacturer technical support Service Contracts Location in the laboratory available space, accessibility Safety Is there a good laboratory infrastructure in place to accommodate the new piece of equipment.Is there a good laboratory infrastructure in place to accommodate the new piece of equipment.

10. Installation Checklist Prior to installation: verify physical requirements have been met Safety checks, electrical, space, ventilation, water supply, ambient temperature, etc. confirm responsibility for installation

11. Installation Upon receipt: verify package contents do not attempt to use prior to proper installation If required, ensure the equipment is installed by the manufacturer

12. Installation After installation Establish inventory record Define conditions Develop and implement protocols for calibration, performance verification, and operating procedures Establish maintenance program Provide training for all operators

13. Instrument Calibration Perform initial calibration Calibrators or standards Follow manufacturer’s instructions Determine frequency of routine calibrations

14. Performance Validation and Operational Verification Validate the performance of new equipment prior to use Test known samples, analyze data Establish stability/uniformity temperature controlled equipment Check accuracy/precision for pipettors Check centrifuge rpms Daily checks before use and running QC

16. Maintenance Program Systematic and routine cleaning, adjustment, or replacement of instrument and equipment parts Performed periodically, daily, weekly, monthly Example: Cleaning optical lenses Thermostat adjustments Changing motor brushes

17. Function Checks Monitoring of instrument to verify that your equipment is working according to the manufacturer’s specification Performed periodically- daily, weekly, monthly Performed after major instrument repair Example: Daily monitoring of temperatures Checking wavelength calibration Checking autoclave indicator paper

18. Weekly Sterilization CheckUse of Biological Indicator (Attest) The laboratory should develop an procedure for the weekly sterilization check using a biological indicator and keep detailed records of each check.

19. Implementing a Maintenance Program Assign responsibility Oversight of all laboratory equipment Individual responsibilities Develop written policies and procedures Train staff Keep records

20. Implementing a Maintenance Program Create a record for equipment inventory Name, Model #, Serial # Location in lab Date purchased Manufacturer and vendor contact information Warranty, expiration date Spare parts

21. Implementing a Maintenance Program For each piece of equipment: Establish routine maintenance plan Establish required function checks Develop a list of spare parts Each piece of equipment should have a label indicating the date in which the next service is due Frequency of routine maintenance procedures and functions checks is an important part of the plan, and must be included in the documented procedure (daily, monthly, yearly) Each piece of equipment should have a label indicating the date in which the next service is due Frequency of routine maintenance procedures and functions checks is an important part of the plan, and must be included in the documented procedure (daily, monthly, yearly)

22. Implementing a Maintenance Program: Documents Develop written procedures for all equipment Concise step-by-step instructions for performing maintenance and function checks Include guide for troubleshooting Establish maintenance records to track: function checks and routine maintenance calibration manufacturer’s service

23. Example Records Charts Logs Checklists Graphs Service Reports

25. Documentation Requirements Name of equipment Date of purchase Serial# or ID Service information Dates of servicing Nature of servicing Name of person performing the servicing Date of next servicing

26. Documentation Requirements A maintenance protocol that outlines function verification and maintenance activities. Documentation of all instrument malfunctions and corrective action(s) taken. Records of all servicing (both preventive and repairs).

27. Equipment Documentation Develop a problem log record for each piece of equipment (Important for future selection) Date problem occurred, removed from service Reason for breakdown or failure Corrective action taken Date returned to use Change in maintenance or function checks

30. Retiring Equipment / Disposition When? When experts indicate not repairable Outmoded, will replace with new equipment Why? Prevent inaccurate test results Free up valuable space Hazardous How? Salvage any useable parts Consider biohazard, follow safety disposal procedures

31. Benefits of a Maintenance Program Safe operations in the laboratory Fewer delays of work Lower repair costs Extend life of equipment Less standby equipment Monitor maintenance cost (selection criteria) More reproducible test results Greater confidence in the reliability of results Better morale of employees

32. Problem Scenario #1 You have just finished running 2 microtiter plates of serum, which had many hemolyzed samples. You were surprised that the negative control O.D. on the second plate was much higher than expected, but still within range. What should you do? What records would you check? Why?

33. Problem Scenario #2 You’re in the middle of performing EIAs and the reader fails. You don’t have a documented procedure for troubleshooting, the maintenance log has not been updated for 2 years, and the manufacturer’s instructions are missing. What should you do? Why?