Instrument Maintenance Quality Assurance Instrument Maintenance

Instrument and equipment quality assurance program include: Reliable instrument and equipment performance is one of the objectives of a comprehensive well structured quality assurance program Instrument and equipment quality assurance program include: Performance verification Function verification Preventive maintenance

1- Performance Verification Involves periodic and systematic checking of an instrument with reference materials or standard solutions: Examples include: Checking wavelength calibration of spectrophotometers using narrow band pass filters at specific wavelengths Verification of thermometer accuracy with an National Institute of Standards and Technology (NIST) –reference thermometer Verification the accuracy of measurements of an analytical balance using NBS class S weights Class S signifies that the weights are for precision laboratory standards for scientific use, and are used for reference, calibration and precision analytical work.

2- Function Verification This involves checking and adjusting an instrument for proper operation These activities include: The recording of temperatures, voltage readings, optical densities, and background counts Instrument calibration, zero adjustment, and linearity adjustment Routine quality control analysis to monitor analysis These procedures are performed on a daily basis or frequently to detect changes in instrument function and to make the necessary corrections The optical density of a substance is the logarithmic ratio of the intensity of transmitted light to the intensity of the incident light passing through the substance.

3- Preventive Maintenance This involves: Cleaning Adjustment Scheduled replacement of parts Preventive maintenance includes Shift, daily, weekly and monthly maintenance procedures performed by technologist or manufacturer service representative Examples include: changing of pumping tubing at regular intervals Changing membranes on electrodes in blood gas analyzers Cleaning sample probes and lines with sodium hypochlorite to remove protein buildup

Responsibilities and Implementation The laboratory manager Responsible for seeing that an effective verification and maintenance program is initiated Periodic evaluation of program effectiveness Ensuring that remedial action is taken when problems arise Documentation availability for accrediting agencies The supervisor Assists in the development of the verification and maintenance program and oversees its implementation He sees that each technologist understands his responsibilities Keeps the manager aware of any deficiencies or problems and to oversee their correction

Responsibilities and Implementation The Technologist Responsible for the performance of verification and maintenance procedures Detection of problems and errors and initiate the necessary corrective action Document all verifications, maintenance and corrective procedures Keep the supervisor informed of any problem The Manufacturer Providing an instrument operators manual and suggested maintenance schedule Provide basic training for laboratory technicians

Steps In Implementation of a verification and maintenance program Gather information concerning operation and performance parameters of all instrumentation and equipment: Tools required for verification and maintenance procedure Reagents, standards, materials to be purchased and stocked Expected hazards Outline the necessary schedules for each procedure and designate responsible individuals Assignment of daily responsibilities, training of personnel Review and update instrument profile. Lab. manager verifies and documents the maintenance profile annually to evaluate its effectiveness

The Basic Outline of an Instrument Verification and Maintenance Profile Demographic information Instrument make/model and serial number Service information including: Manufacturer's address Service and technical representative's address and telephone number Type of service contract and the contract reference or purchase order number Warranty information listing: Effective dates of the warranty What the warranty covers Conditions that may invalidate warranty How to get help with warranty problems

The Basic Outline of an Instrument Verification and Maintenance Profile Laboratory personnel training and skill levels required for: Operation Routine maintenance Repair and nonroutine service Requirements for the installation and proper operation of the instrument including Environmental conditions (temperature and lighting) Electrical and water utilities requirements

The Basic Outline of an Instrument Verification and Maintenance Profile Brief discussion of the principles of operation Parts and equipment necessary for performance and function verification and preventive maintenance listing the necessary tools, reagents, and standards Schedule of verification and maintenance procedures listing the following: 1. Instructions on how to perform each procedure 2. Schedule and checklist for performance of each procedure 3. Reference to instrument manual

The Basic Outline of an Instrument Verification and Maintenance Profile Precautions listed 1. Personnel safety precautions 2. Protection of the instrument 3. Procedures that should not be attempted by the user References 1. Instrument manual 2. Other important references

Service Contracts Service contracts are provided by many manufacturers of instruments or by independent service vendors to perform routine preventive and emergency maintenance on the larger and more complex instruments Full service or partial service contracts may be needed.

Service Contracts In choosing the level of maintenance consider the following: The complexity of the instrument Some instruments do not need experts for maintenance e.g. microhematocrit centrifuge Other instruments need full- time service contract or part- time service or purchase service when needed Urgency of the test If the test is a stat, contract for 24 h, 7 days service is needed, if the test is not urgent, it is more economical to purchase a 5- day contract Charges for routine replacement parts maintenance on a competitive basis "maintenance by third- party companies"

Non-routine Maintenance, trouble shooting the malfunctioning instrument Problems requiring extra effort to overcome, the following guide lines may help solve the problem: Do not panic Define the problem Is there any past experience on the same problem Try the simplest approach to solve the problem Replace good parts for bad Ask for help from a supervisor or contact the manufacturer if the above solutions fail The instrument serial number, service contract, purchase order, service provider's name and telephone number should be posted on each instrument for easy access.