Professional Documents
Culture Documents
FACILITY REQUIREMENTS
Performance xtics
Cost
Reagents
Ease of use
Language of instruction
Warranty
Safety
Space (Will it fit)
Equipment acquisition
Conditions of contract
Request:
- Wiring diagrams
- Software diagrams
- Parts list
- Operator manual
- Installation by manufacturer
- Trial period
Before Installation
Establish checklist
MAINTENANCE PROGRAM
Overview:
An equipment mgt program address:
- Equipment selection
- Preventive maintenance
- Procedures for trouble shooting & repair
Implementation
Maintain records
Benefits
Reliability of results
ACCREDIATION
Self-developed Standards
Advantages:
- optimized for local use, recognized local strengths & weaknesses
- can be developed in progressive steps
- can lead to full international recognition
Weaknesses:
CLSI
Promotes the development and use of voluntary consensus standards and guidelines within
the health care community
WHO
Standards are applicable to many kinds of organizations including clinical and public health
laboratories
CEN
National standards bodies in the European Economic Community and associated countries
- ISO 9001:2000
- ISO 14000
Accreditation standards
- ISO 17025
- ISO 15189
- WHO polio standards
Regulations
- US CLIA Regulations
- French GBEA
- UN Transport of Dangerous Goods Regulations
Accreditation outcomes
SUMMARY
GOOD
DOCUMENTATION
PRACTISE
Definition
Legible
- Readable and signatures identifiable
Contemporaneous
- Info should be noted in the correct time frame along with the flow of events. Delay should be defined &
justified
Original
-Original, if not original should be exact copy; the first record made by the appropriate person. The
investigator should have the original source document.
Accurate
-Accurate, consistent and real representation of facts
- Protocol
- CRF guidelines
- Lab procedures
- Regulations
Data are complete, accurate, legible and timely
Items (data fields) are completed per CRF completion
guidelines
Errors are corrected following good documentation practices
Cont
Write legibly