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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Information Management. . . . The Quality System. Proper Maintenance of Equipment is Vital .
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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?