# Presentation: 489237

## Equipment

**Equipment**

**Notes:**
Key Message (Scripted Notes):

## The Quality System

**Information Management**

## Problem Scenario #1

- You’re in the middle of performing ELISAs 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?

## Functioning Equipment is Vital for:   

- Producing reliable test results
- Minimizing instrument breakdown
- Lowering repair costs
- Preventing delays in reporting test results
- Maintaining productivity

**Notes:**
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.

## A Good Equipment Program Achieves 

- Maintaining a high level of performance
- Lengthening instrument life
- Reducing interruption of services due to breakdowns and failures
- Improving customer satisfaction
- Improving the technologist’s confidence and  knowledge

**Notes:**
A good equipment program plays an important role in the quality assurance of a laboratory to be able to produce reliable results.

## Basic Laboratory Equipment

- Microscope
- Balance/scale
- Centrifuge
- Micropipette
- Spectrophotometer
- Refrigerator
- Freezer

- Autoclave
- Hot air oven
- Incubator
- pH Meter
- Water bath
- Washer
- Shaker / rotator
- Vortex

**Notes:**
Highly sophisticated laboratories such as central or reference may also have automated analysers e.g. for EIA, CD4, PCR.

## Equipment Management 

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

**Notes:**
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, 

## Equipment Management Oversight

- Assign responsibilities for all activities
- Train _*all*_ personnel on equipment management requirements and responsibilities
- Monitor equipment management activities by:
- Routinely reviewing all records
- Ensuring all procedures are followed
- Updating procedures, if necessary

**Notes:**
Training of laboratorians and monitoring of equipment are also important roles of the equipment manager.

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## Selection Criteria

- Use
- Matching equipment with service provided
- Performance characteristics
- Facility requirements
- Cost
- Supply of reagents
- Ease of operation
- Warranty
- Availability of manufacturer technical support
- Service Contracts

**Notes:**
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.

## Selection Criteria

- Location in the laboratory
- available space, accessibility
- Safety

**Notes:**
Is there a good laboratory infrastructure in place to accommodate the new piece of equipment.

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## Acquiring Equipment

- Purchase, Lease, or Rent
- Central acquisition
- Bulk procurement
- Donor provided
- Conditions of contract

**Notes:**
Pros and Cons of Purchase or Rent
Pro Purchase		VS		Against Purchase
Ownership				Total Responsibility

## Acquiring Equipment

- Contract considerations:
- Parts Manual
- Installation
- Operators’ Manual
- Trial period
- Contents of service contracts

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## 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

## 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

## 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

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## Equipment Calibration

- Perform initial calibration
- Calibrators or standards
- Follow manufacturer’s instructions
- Determine frequency of routine calibrations

## Performance Validation

- 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

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## 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

## Function Checks

- Monitoring of instrument parameters to verify that 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

## Implementing a Maintenance Program

- Assign responsibility
- Oversight of all laboratory equipment
- Individual responsibilities
- Develop written policies and procedures
- Train staff
- Keep records

## 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

## Implementing a Maintenance Program 

- For each piece of equipment:
- Establish routine maintenance plan
- Establish required function checks
- Develop a list of spare parts

**Notes:**
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)

## Implementing a Maintenance Program: Spare Parts

- Establish and maintain an inventory of most frequently used spare parts.  Include in record of inventory:
- Spare parts per equipment
- Part number
- Average use
- Minimal # of items to be stored
- Cost and date of ordering
- Dates of entry and issuance of part from inventory stock
- Balance of items remaining in inventory

## 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

## Sample Records

- Charts
- Logs
- Checklists
- Graphs
- Service Reports

## Slide 31

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## Troubleshooting

- Check manufacturer’s instructions
- Determine source of problem
- Sample problem
- Reagent problem
- Equipment problem
- Check electrical supply
- Check water supply
- Make one change at a time

## When In-house efforts fail:

- Do NOT use equipment that does not function properly
- Options for testing:
- Refer to nearby laboratory
- Obtain backup instrument from central stores
- Store samples appropriately
- Seek help from manufacturer or other technical expert
- Place a malfunction notice on equipment

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## Service and Repair

- Schedule service that must be periodically performed by the manufacturer
- Options
- Centrally service small equipment, e.g., microscopes, washers, pipettes
- Team of biomedical service technicians

**Notes:**

Schedule service that must be periodically performed by the manufacturer  - This service should have been part of the negotiated contract agreement 

Team of biomedical service technicians – This trained team would service the entire country 

## Equipment Documentation

- Develop a  problem log record for each piece of equipment
- Date problem occurred, removed from service
- Reason for breakdown or failure
- Corrective action taken
- Date returned to use
- Change in maintenance or function checks

## Equipment Management

- Selection
- Acquisition
- Installation
- Calibration / Validation
- Maintenance
- Troubleshooting
- Service and repair
- Retiring equipment / disposition

## Slide 39

## 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

## Benefits of a Maintenance Program

- Safety
- Fewer interruptions of work
- Lower repair costs
- Elimination of premature replacement
- Less standby equipment
- Identification of high maintenance cost
- Reduction of variation in test results
- Greater confidence in the reliability of results