1. INSTRUMENT MAINTENANCE

2. Introduction
Reliable instrument and equipment performance is one of the objectives of a comprehensive well structured quality assurance program.
Proper management of the equipment in the laboratory is necessary to ensure accurate, reliable and timely testing.

3. The Benefits of a Good Equipment Management Program
Helps to maintain a high level of laboratory performance.
Reduces variation in test results, and improves the technologist’s confidence in the accuracy of testing results.
Lowers repair costs, as fewer repairs will be needed for a well-maintained instrument.
Lengthens instrument life.
Reduces interruption of services due to breakdowns and failures.
Increases safety for workers.
Produces greater customer satisfaction.

4. Program Monitoring
It is the responsibility of the laboratory director to:
oversee all the equipment management systems in the laboratory;
ensure that all persons who will be using the instruments have been:
appropriately trained and understand how to both properly operate the instrument and
perform all necessary routine maintenance procedures.
Equipment management responsibility may be specifically assigned to a technologist in the laboratory.
In many laboratories, there is a person who has good skills with equipment maintenance and troubleshooting.
Giving this person the role of oversight of all equipment is recommended.

5. Program Considerations
A great deal of thought and planning should go into equipment management.
As the laboratory puts an equipment management program in place, the following elements should be considered:
Selection and purchasing
Installation
Calibration and performance evaluation
Maintenance
Troubleshooting
Service and repair
Retiring and disposing of equipment

6. Program Considerations Selection and Purchasing
Selecting the best instrument for the laboratory is a very important part of equipment management.
Some criteria to consider when selecting laboratory equipment are listed below:
What are the performance characteristics of the instrument?
Is it sufficiently accurate and reproducible to suit the needs of the testing to be done?
What are the facility requirements, including the requirements for physical space?
Will the cost of the equipment be within the laboratory’s budget?
Will reagents be readily available?

7. Program Considerations Selection and Purchasing
How easy will it be for staff to operate?
Is there a retailer for the equipment in the country, with available services?
Does the equipment have a warranty?
Are there any safety issues to consider?
If decisions are made outside the laboratory, the lab. manager should provide information that will support selecting equipment that will best serve the needs of the lab.
If donors are likely to provide some of the equipment that is used, lab. management should have input into the choice of equipment otherwise management should consider declining equipment if it is inappropriate for laboratory needs.

8. Program Considerations Selection and Purchasing
Is it better to purchase or lease equipment? When making this decision, it is a good idea to factor in repair costs.
The manufacturer should provide all of the necessary information to operate and maintain equipment.
The initial cost of an instrument may seem reasonable, but it may be expensive to repair.

9. Program Considerations Selection and Purchasing
Before purchasing ask if:
Wiring diagrams, computer software information, a list of parts needed, and an operator’s manual are provided;
The manufacturer will install the equipment and train staff (covering travel expenses as necessary) as part of the purchase price;
The warranty includes a trial period to verify that the instrument performs as expected;
The manufacturer’s maintenance can be included in the contract and, if so, whether maintenance is provided on a regular basis.
Determine if the laboratory can provide all the necessary physical requirements, such as electricity, water, and space.
There must be adequate room to move the equipment into the laboratory; consider door openings and elevator access.

10. Program Considerations Calibration and Performance Evaluation
Follow the manufacturer’s directions carefully when performing the initial calibration of the instrument.
It is a good idea to calibrate the instrument with each test run, when first putting it into service.
Determine how often the instrument will need to be recalibrated, based on its stability and the manufacturer’s recommendation.
It may be advantageous to use calibrators provided by or purchased from the manufacturer.

11. Program Considerations Calibration and Performance Evaluation
Prior to testing patient specimens, it is important to evaluate the performance of new equipment to ensure it is working correctly with respect to accuracy and precision.
Laboratories need to verify the manufacturer's performance claims, and demonstrate they can get the same results using the kits or equipment in their laboratory, with their personnel.
Some of the steps that should be followed to verify performance include:
testing samples with known values and comparing the results to the expected or certified value;
if equipment is temperature controlled, establishing the stability and uniformity of the temperature.

12. Program Considerations Calibration and Performance Evaluation
In order to verify that equipment is working according to the manufacturer’s specifications, it is necessary to monitor instrument parameters by performing periodic function checks.
This should be done before using the instrument initially, then with the frequency recommended by the manufacturer.
These function checks should also be done following any instrument repairs.
Some examples of function checks are daily monitoring of temperatures and checking the accuracy of wavelength calibration.

13. Program Considerations Preventive Maintenance
Preventive maintenance includes measures such as systematic and routine cleaning, adjustment and replacement of equipment parts at scheduled intervals.
Manufacturers generally recommend a set of equipment maintenance tasks that should be performed at regular intervals: daily, weekly, monthly or yearly.
Following these recommendations will ensure that the equipment performs at maximum efficiency and will increase the lifespan of the equipment. This will also help to prevent:
inaccurate test results due to equipment failure
delays in reporting results
low productivity
large repair costs.

14. Program Considerations Troubleshooting
Manufacturers frequently provide a flowchart that can help determine the source of problems.
Some of the questions to consider are listed below.
Is the problem related to a poor sample? Has the sample been collected and stored properly? Are factors such as turbidity or coagulation affecting instrument performance?
Is there a problem with the reagents? Have they been stored properly, and are they still in date? Have new lot numbers been introduced without updating instrument calibration?
Is there a problem with the water or electrical supply?
Is there a problem with the equipment?

15. Equipment Maintenance Documentation
Equipment documents and records are an essential part of the quality system.
The policies and procedures for maintenance should be defined in appropriate documents, and keeping good equipment records will allow for thorough evaluation of any problems that arise.

16. Equipment Maintenance Documentation
Each piece of equipment should have a dedicated logbook documenting all characteristics and maintenance elements, including:
preventive maintenance activities and schedule;
recording of function checks and calibration;
any maintenance performed by the manufacturer;
full information on any problem that the instrument develops, the subsequent troubleshooting activity and follow-up information regarding resolution of the problem.

17. Equipment Maintenance Documentation
In recording problems, be sure to record
date problem occurred and when equipment was removed from service;
reason for breakdown or failure;
corrective action taken, including a note about any service provided by the manufacturer;
date returned to use;
any changes to procedure for maintenance or function checks as a result of the problem.

18. QUALITY ASSURANCE OF REAGENTS, SUPPLIES, AND LABORATORY WATER

19. Introduction
In order to produce high quality work, a laboratory requires a constant supply of good quality reagents, supplies and water
A deficiency of any of these can cause the most efficient laboratory either to come to a standstill or to provide substandard service

20. Choice and Evaluation of Reagents and Supplies
A selection of a brand of reagent for instrument system or laboratory tests is made after searching and gathering information concerning the reagent sensitivity, preparation, storage, and cost
Next, an evaluation of the selected material is performed in the laboratory, comparing the new reagent to the old
If the comparison is favorable, the new reagent is purchased

21. Choice and Evaluation of Reagents and Supplies
Before committing to purchase insists on performing a field trial of the reagent
Factors that should be considered in selecting and evaluating a new reagent or material supplies are:
Sensitivity
Stability and storage conditions
Vendor reputation
Delivery time
Cost

22. Reagents Prepared in the Lab.
Reagents, standards and controls prepared in the laboratory from stock chemicals should be:
Prepared using class A volumetric glassware and properly calibrated balances
To eliminate variation (batch to batch), preparation should be limited to one or two persons
Label each reagent, standard, and control with the following:
The name of the material
The procedure for which the material is to be used
Date of preparation
Date of expiration
Initials of the person who prepared it

24. Laboratory Water
Reagent - grade water must be properly purified and periodically inspected for:
Electrical resistivity
Resistivity (R) of water is the measurement of electrical resistance and is the inverse of electrical conductivity (C)
R and C are directly related to the number of inorganic ions and conduction particles in the water
The greater the ionic concentration, the greater the electrical conductivity and the less the electrical resistance
Measurements are made using a resistivity or conductivity meter
Soluble silica concentration
Measured by a chemical reaction between silicate and molybdate ions to form a blue complex, intensity is proportional to conc.

25. Laboratory Water Desired pH Bacterial contamination
The pH is measured with pH meter. Pure water contains so few ions that measurement of pH is not necessary if resistivity is very high
Bacterial contamination
The microbiological content of the water is defined as the number of colony - forming units per milliliter of water
Three recommended methods:
Pour plate (1 ml of water)
Add 1 ml of well mixed water to a nutrient-supplemented medium and incubate for 24h at 36 ± 1oC
Membrane filtration
Using a sterile vacuum membrane filter system to filter microbes, then incubate the filter on medium for 24h at 36 ± 1oC
Calibrated loop for sampling (0.01 ml)
Inoculate agar plate. Incubate for 24h at 36 ± 1oC

26. Laboratory Water
Purification of water can be achieved through 3 methods:
Distillation
Deionization
Reverse osmosis
Additional purity is obtained with charcoal filtration.

27. Laboratory Water Water Grades According to Purity
Type I water:
The highest level of purity,
used for:
tissue and cell culture methods
special and critical analytical chemical analysis
and in preparation of standard solutions
Type II water:
Used for most routine quantitative clinical laboratory methods
It should be stored for short periods of time before use, to prevent change in resistivity and bacterial growth

28. Laboratory Water Water Grades According to Purity
Type III water:
The least pure
Suitable for most qualitative procedures including:
Urine analysis
parsitology
and histology
Suitable for glassware washing
Stored in containers that protect it form contamination

29. Laboratory Water Water Grades According to Purity

30. Laboratory Inventory Management

31. Introduction
Purchasing and inventory management is a critical and essential component of the quality management system.
Efficient and cost-effective laboratory operations need the uninterrupted availability of reagents, supplies and services.
Inability to test, even for a short time, is very disruptive to clinical care, prevention activities and public health programs.

32. Goals of Laboratory Inventory Management
Effective inventory control involves setting up a system that has the following goals:
Improve communication between the laboratory and the other hospital departments involved in purchasing, stocking, and paying for supplies
Manage inventory so that shortages and overstocking should be avoided
Teaching laboratory employees better budgeting and materials management techniques

33. Inventory Control Program
Designing and implementing an inventory control program involves :
The identification of the needed supplies
Their rate of use
Periodic review and evaluation of the inventory and ordering process

34. Inventory Control Program
Conduct a survey to list all of supplies that the laboratory uses, the list should include:
The name of the item
A brief description
Approximate usage per month
Current vendor
Order unit amount
Current unit packing, that is per box, carton, or bag
Order or catalogue number
Priority of need
Assigning an item its relative importance
High priority: if needed constantly or cannot be done without
Medium priority: if needed occasionally
Low priority: if needed rarely

35. Inventory Control Program
The next step is to determine the order point, order quantity and lead time for the item
Order point:
The sum of the minimum inventory plus the emergency supply
The level of inventory at which an order is generated
The minimum inventory is the amount of the material necessary to perform the routine work until the next shipment arrives
The emergency supply is a reserve of supplies held aside to meet an unexpected increase in the workload or a delay in delivery of the new order

36. Inventory Control Program
Determination of the order point and order quantity will depend on the space the lab. Has available for storage, its rate of use and the lead time of the material
Lead Time:
is the length of time between initiating an order and receiving it in the laboratory

37. Inventory Control Program
Controlling inventory involves the counting, storage and movement of supplies within the laboratory
A written record system of inventory levels and checks should be devised
Three types of record systems are suggested:
The periodic count
Strict inventory control is not required
Count of materials weekly or every two weeks, when count reaches the order point, an order is generated
Good for small to midsize Lab.

38. Inventory Control Program
The continuous inventory record
Strict inventory control is required
Inventory is closed to lab. Personnel, one or two persons manage it
Good for larger lab.
The specialized inventory record
Used for slow-moving, infrequently ordered parts such as instrument spare parts
Parts are not ordered until inventory is used
Once the inventory system has been set up, it should be reviewed annually for updating
Perpetual: continuous