MT6316 CHAPTER VIII Flashcards
What is necessary to ensure accurate, reliable and timely testing?
Equipment Management
Benefits of Good Equipment Management include?
- high level of laboratory performance
- reduces variation in test results and improves the technologist’s confidence in the accuracy of testing results
- lower repair costs
- lengthens instrument life
- reduces interruption of services due to breakdowns and failures
- increases safety for workers
- greater customer satisfaction
Program Considerations for Equipment Management?
- Selection and purchasing
- Installation
- Calibration and performance evaluation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring and disposing of equipment
Criteria to consider in Selecting equipment?
- matched against the service the laboratory provides
- performance characteristics of the instrument
- sufficiently accurate and reproducible to suit the needs of the testing to be done
- facility requirements
- cost
- reagent availability
- staff operation
- instruction availability
- equipment retailer
- warranties
- safety issues
Things to consider in acquiring equipment?
- purchasing or leasing
- factor in repair costs
- manufacturer should provide all of the necessary information to operate and maintain equipment
- savings that could be negotiated if the laboratory needs more than one piece of equipment
LEASE OR RENTAL PLANS: periodic payments are made without purchase option
RENTAL
LEASE OR RENTAL PLANS: the equipment is returned
RENTAL
LEASE OR RENTAL PLANS: agreed or metered
RENTAL
LEASE OR RENTAL PLANS: periodic payments are made
LEASE
In lease plans, how far apart are the periodic payments?
3-5 years
LEASE OR RENTAL PLANS: purchased for longer periods at reduced rate.
LEASE
In acquiring equipment, is it best to ask about what before purchasing?
- 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, whether maintenance is provided on a regular basis
Acquisition of new equipment justifications?
Replacement
Increased workload
Cost reduction
New and / or improved methodology
equipment can not be repaired or excessive cost of repair results in unacceptable delays
Replacement
volume increase justifies either automation or additional personnel
Increased workload
reduction of operational expenses state primarily in terms of personnel and supplies
Cost of reduction
better patient care
New and / or improved methodology
Priority of needs in equipment management?
1.Essential
2.Necessary
3.Desirable
4.Others
Needed immediately to maintain quality patient care
Essential priority
As “essential” but greater leeway with regard to time of acquisition
Necessary priority
Means of reducing cost
Desirable priority
Means of improving general working condition
Others priority
Act of verifying is all physical requirements have ben met
Installing equipment
Consideration in installing equipment?
vendor’s responsibilities for installation should be confirmed in writing prior to beginning the installation process
What should be developed in installing the equipment?
checklist of the expected performance specifications, so that performance can be quickly verified as soon as the equipment is installed
In getting the equipment ready for use, assign responsibility for?
performing the maintenance and operation programs.
What is assigned to perform the maintenance and operation programs? (Getting equipment ready for use)
Responsibility
Develop a _________ for recording the use of parts and supplies.
system
What should be implemented in the process of getting the equipment ready for use?
a written plan for calibration, performance verification, and proper operation of the equipment.
What should be scheduled in the readying of equipment for use?
scheduled maintenance program that includes daily, weekly and monthly maintenance tasks.
In getting the equipment ready for use, provide what to a all operators?
training
Who should be the only ones authorized as operators?
only personnel who have been trained specifically to properly use the equipment
Follow the manufacturer’s directions carefully when performing the?
initial calibration of the instrument.
Calibrate the instrument ________, when ____________.
with each test run
first putting it into service
Determine ____________, based on its stability and the manufacturer’s recommendation.
how often the instrument will need to be recalibrated
Prior to testing patient specimens, it is important to evaluate the performance of _____________ to ensure it is working correctly with respect to _______________.
new equipment
accuracy and precision.
____________ using __________________ need to be evaluated for the ability to detect ________________ and to determine ______________________.
Test methods
kits or laboratory instruments
disease (sensitivity, specificity, positive and negative predictive value)
normal and reportable ranges.
One of the pressing issues that DOH is regulating in relation to the COVID-19 crisis is?
opening new molecular testing labs with new equipment (or equipment not validated for diagnostic use) and using unvalidated testing kits.
Manufacturers provide _______________ for testing methods using their kits or instruments, and include the information in the package inserts or operator’s manuals
performance evaluations
Manufacturers provide performance evaluations for what using what?
testing methods using their kits or instruments, and include the information in the package inserts or operator’s manuals
Laboratories need to verify the ________________, and demonstrate they can get the same results using the kits or equipment in their laboratory, with their personnel.
manufacturer’s performance claims
Verification of manufacturers’ performance claims includes?
- 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
What can be carried out by running samples in parallel using both old and new equipment and methods for a period of time to determine that the expected results can be obtained?
Validation
Validation can be carried out by?
running samples in parallel using both old and new equipment and methods for a period of time to determine that the expected results can be obtained.
A maintenance plan should include?
- preventive maintenance
- provision for inventory
- troubleshooting
- repair of equipment
Implementing an equipment maintenance program includes?
A. Preventive Maintenance
B. Repair
C. Calibration
Comes before a failure, while the equipment is in operating condition
A. Preventive Maintenance
Applies to unscheduled maintenance
B. Repair
Comes after the instrument has failed
B. Repair
Assurance that the instrument measures certain parameters within specified tolerance
C. Calibration
Considered part of preventive maintenance
C. Calibration
Initial steps in implementing equipment maintenance program include?
- assigning responsibility for providing oversight
- developing written policies and procedures for maintaining equipment, routine maintenance plans for each equipment that specify the frequency maintenance tasks should be performed
- developing records, creating logs and forms, and establishing the processes to maintain records
- training staff on the use and maintenance of the equipment, ensuring that all staff understand their specific responsibilities
Preventive maintenance includes measures such as?
systematic and routine cleaning, adjustment and replacement of equipment parts at scheduled intervals
Should be performed at regular intervals: daily, weekly, monthly or yearly
Preventive maintenance
Preventive maintenance ensures that the equipment performs at maximum efficiency and will increase the lifespan of the equipment and help to prevent?
- inaccurate test results due to equipment failure
- delays in reporting results
- low productivity
- large repair costs
Laboratory should keep an ____________ of all equipment in the laboratory.
inventory log
Should be updated with information on new equipment and include documentation of when old equipment is retired
Log
Troubleshooting equipment is needed when the operator notices changes such as?
- drift in quality control or calibrator values
- obvious flaws in equipment function
- equipment fails to operate
If problems cannot be identified and corrected in-house, attempt to find a way to continue testing until the equipment can be repaired, through?
- Arrange to have access to backup instruments.
- Ask the manufacturer to provide a replacement instrument during repairs.
- Send the samples to a nearby laboratory for testing (must be in accordance to state regulations such as DOH AO 2007-027 on the referral of specimens).
- Place a note on the equipment so all staff are aware that it is not in use.
Who provides service and repair of equipment?
manufacturers from where the equipment is purchased.
Set up a ______ for scheduling service that must be periodically performed by the _________
procedure
manufacturer
Some warranties require that repairs be handled only by who?
the manufacturer.
Large facilities sometimes have what professionals who perform equipment maintenance and repair?
biomedical service technicians inhouse
____________ should be scheduled so as not to interrupt the flow of work.
Routine service
Retiring and disposing of equipment occur when the instrument is?
- not functioning and not repairable
- outmoded and should be replaced with new equipment
What should be disposed of in an appropriate manner so that it will not accumulate, take up valuable space and create hazard?
Fully retired equipment
Fully retired equipment should be disposed of in an appropriate manner so that it will not?
accumulate, take up valuable space and create hazard
When disposing of equipment, what should be done?
- salvage any usable parts, particularly if the equipment is being replaced with another similar one.
- consider any potential biohazards and follow all safety disposal procedures
T or F: Each major piece of equipment will have its own equipment maintenance document.
T
Smaller, commonly used equipment such as centrifuges and pipettes may be managed with what document/s?
an equipment maintenance document or manual that deals with all such equipment in the laboratory
An equipment maintenance document should include?
- step-by-step instructions for routine maintenance, including frequency of performance and how to keep records of maintenance instructions for carrying out function checks, frequency of performance, and how to record the results
- directions for calibrating the instrument
- guide for troubleshooting
- any required manufacturer’s service and repair
- list of any specific items needed for use and maintenance, such as spare parts
“uninterrupted availability of reagents, supplies and services is needed for efficient and cost-effective laboratory operations”
Purchasing and Supplies Inventory Management
Benefits of Purchasing and Supplies Inventory Management?
- supplies and reagents are always available when needed
- high-quality reagents are obtained at an appropriate cost
- reagents and supplies are not lost due to improper storage, or kept and used beyond expiration
Key components of Purchasing and Supplies Inventory Management?
- vendor/manufacturer qualifications
- purchase agreements
- receiving, inspecting, testing, storing, and handling of materials
- must allow for tracking materials to individual patients
- assessing and maintaining inventory
- controlling expiration periods
- dispatching supplies to satellite laboratories
All purchased material should be ____________________ to ensure that specifications are met, and policies should be established for storing and handling materials as they are delivered to the laboratory
inspected and appropriately tested
The laboratory should be able to ____________ for performing tests on any given day, so that if there is a problem with a patient result, the laboratory will know what reagents were used
identify specific test materials used
PRODUCT RESEARCH OR PRODUCT SPECIFICATIONS:
comparative evaluation by consultation with other users
PRODUCT RESEARCH
PRODUCT RESEARCH OR PRODUCT SPECIFICATIONS:
help assure adequate quality of materials
PRODUCT SPECIFICATIONS
PRODUCT RESEARCH OR PRODUCT SPECIFICATIONS:
by reference to publications offering comparative studies of equipment and supplies.
PRODUCT RESEARCH
PRODUCT RESEARCH OR PRODUCT SPECIFICATIONS:
inventory control helps quality of purchased after reagents and supplies
PRODUCT SPECIFICATIONS
In purchasing, specifically selecting vendors, the laboratory should?
- define criteria for supplies or materials to be purchased
- look for the best price, taking into account the qualifications and credibility of the supplier
- consider the advantages and disadvantages of purchasing “brand name” compared to “generic” products
T or F: It may be useful to seek information from other laboratories when considering quality, reliability of supply and cost.
T
What are the factors to consider when evaluating vendors after purchase?
whether the vendor delivered the specified goods
whether the central procurement body assured that user specifications were met
Documents involved in the purchasing process?
- Purchase requisition or order
- Packing slip
- Invoice
states the desired goods or services with an estimate of the cost.
Purchase requisition or order
accompanies the shipped goods
Packing slip
Where payment is made
Invoice
What are the considerations in setting up purchasing procedures?
Understand any local or national government requirements that need to be accommodated in the contracts.
Negotiate for the best price without undermining quality.
Carefully review all contracts to make sure the laboratory’s requirements are being met.
Ask if there are penalties for ending a contract.
Determine how payments will be made, and how the vendor will assure reliable availability and delivery of supplies and reagents.
_______ should clearly address payment mechanisms and provisions to assure ______________ of reagents and supplies.
Contracts
reliable availability and delivery
Steps for implementation?
- Assign responsibility-without this, nothing may get done.
- Analyze the needs of the laboratory.
- Establish the minimum stock needed for an appropriate time period.
- Develop needed forms and logs.
- Establish a system for receiving, inspecting and storing supplies.
- Maintain an inventory system in all storage areas and for all reagents and supplies used in the laboratory.
very important process that can help calculate how much is required of any particular item for a given period of time
Quantification
performed when making annual plans for the laboratory and this planning will take into account the usual usage of supplies and reagents
Quantification
Accurate quantification will?
- ensure essential supplies will be available when needed
- prevent overstocking, which can lead to wastage of expensive materials.
Quantification provides information for?
- estimating annual budget requirements
- allowing for better planning
- making decisions and monitoring performance of the inventory management system
Good tools for managing the stock include?
- standardized forms
- card systems
- log books
For any system that is used, the following information should be recorded?
- date reagent or set of supplies are received
- lot numbers for all supplies, reagents and kits
- pass or fail acceptance criteria
- date the lot number or box of supplies was put into service or, if not usable, the date and method of disposition
All supplies and reagents should be _________ as they arrive in the laboratory to be sure _________ and to __________________.
inspected
that they are in good condition
verify that what is received is what was ordered.
Additional task for receiving personnel, include?
- sign their name verifying receipt
- date each item received
- note expiration date
- store new shipment behind existing shipment
- create or update logbook records
Good practices in storage of supplies?
- Keep the storeroom clean, organized and locked
- Make sure storage areas are well ventilated and protected from direct sunlight.
- Ensure storage conditions are in accordance with the manufacturer’s instructions
- Use good shelving strong enough to support items, and organize items carefully on the shelves to prevent movement shifts or falls.
- Ensure items are accessible to staff.
- When storing, put the new shipment behind existing materials that are already in the laboratory.
______ should be attached firmly to support walls to prevent tipping.
Shelves
_________ should be available for reaching higher shelves and heavier items should be stored on lower shelves; laboratory staff should not be required to lift heavy items.
Sturdy step stools
Organize the reagents and materials so that the (older/newer) materials get used first
older
“Procedures should be developed and put in place for continuous monitoring of the inventory. “
Monitoring Inventory
To ensure that Monitoring Inventory is done effectively, one must?
- assign the responsibility for this task to an appropriate person or person
- be sure that all supplies and reagents are covered by the system and maintain inventory management in all of the storage areas
- conduct weekly physical counts of reagents and supplies in order to check the system
- make sure that all records are updated and maintained
Ability to differentiate the patient and healthy
cases correctly
Accuracy
Equation for Accuracy
TP+TN / TP+TN+FP+FN
Ability to determine the patient cases correctly
Sensitivity
Equation for Sensitivity
TP / TP+FN
Ability to determine the healthy cases correctly
Specificity
Equation for Specificity
TN / TN+FP
Proportion of cases giving positive test results who are already patients
Positive predictive value
It is the ratio of patients truly diagnosed as positive to all those who had positive test results (including healthy subjects who were incorrectly diagnosed as patient).
Positive predictive value
This characteristic can predict how likely it is for someone to truly be patient, in case of a positive test result.
Positive predictive value
Equation for Positive predictive value
𝑇𝑃𝑇𝑃+𝐹𝑃
It is the proportion of the cases giving negative test results who are already healthy.
Negative predictive value
It is the ratio of subjects truly diagnosed as negative to all those who had negative test results (including patients who were incorrectly diagnosed as healthy).
Negative predictive value
This characteristic can predict how likely it is for someone to truly be healthy, in case of a negative test result.
Negative predictive value
Equation for Negative predictive value
𝑇𝑁𝑇𝑁+𝐹𝑁
Indicator for monitoring of incubator
Temp and CO2
FREQUENCY OF QC TESTING: Incubator
Daily
FREQUENCY OF QC TESTING: Anaerobe chamber
Daily
FREQUENCY OF QC TESTING: Gaspak Jar
Every use
FREQUENCY OF QC TESTING: Autoclave
Each load, weekly
FREQUENCY OF QC TESTING: Microscope
Quarterly
FREQUENCY OF QC TESTING: Centrifuge
Biannually
FREQUENCY OF QC TESTING: At least one a year or when transferred to another location
Biohazard Hood
FREQUENCY OF QC TESTING: At least ONCE a year
Analytical balance
INDICATOR FOR MONITORING: Anaerobe jar
Anaerobiosis
Catalyst-heated
INDICATOR FOR MONITORING: Autoclave
Temp
Spore testing
INDICATOR FOR MONITORING: Microscope
Cleaned and adjusted
INDICATOR FOR MONITORING: Centrifuge
Check rpm
INDICATOR FOR MONITORING: Biohazard Hood
Air flow
INDICATOR FOR MONITORING: Analytical balance
Weights accuracy
