b. Material control

b. Material control

1. specimen collection & delivery (transportation)

   • to comply to suitable & accurate procedure of:
     • 1. specimen collection
     • 2. specimen preservation (suitable anticoagulant)
     • 3. completion of requisition form & labeling of specimen
     • 4. specimen storage
     • 5. delivery of specimen

2. rejection of test requisition

   • 1. incomplete form/improper labeling of specimen
   • 2. info mismatch on request form & specimen label
   • 3. haemolysed blood specimen/ lipaemic
   • 4. activated specimen
   • 5. unsuitable specimen
   • 6. unsuitable specimen tube
   • 7. unsuitable specimen volume
   • 8. not conform to the storage & delivery system

3. quality objectives (Laboratory Standards)

   • same as before in a) design control

4. assets

   • main instruments
   • small instruments & apparatus
   • performance specifications
     • 1. principles
     • 2. analysis & display range
     • 3. accuracy
     • 4. reproducibility
     • 5. linearity
     • 6. carryover
     • 7. correlation
     • 8. QC
     • 9. sample volumes
     • 10. parameters

5. reagents & disposables item

   • 1. proper grade
   • 2. correct preparation technique
   • 3. proper storage
   • reagent inventory
     • responsible of lab manager to ensure supplies & reagents are available as needed
       • monitoring usage & inventory levels
       • ordering/reordering supplies & reagents as when it reach stock re-order level (critical level)
     • responsible of users (MLTs) to record reagent usage

6. employees

   • foundation of a lab success
   • skillful, reliable, have an interest in clinical diagnostic science & be able to recognize their responsibility for human lives
   • their roles are based on academic qualification & technical expertise & experience
   • advance their career by acquiring additional education or technical experience, beginning with the MLT program & progressing to a lab management or specialist

7. laboratory safety

   • delivered through lab safety program
     • to minimize the risk of injury & illness
   • objective: to build a safety culture in order to achieve a common goal of lab safety among all levels of lab personnel
   • plan for evacuation in case of emergency- fire emergency plan, Medical EP, Chemical EP
   • safety equipment in emergency- eye wash stations, showers, spill kits, first aid kits, fire blankets, fire extinguishers, emergency exits
   • inventory of chemicals stored & used in labs or storage areas must be completed annually
   • safety self-audits of labs are to be completed by primary investigators (internal: eg senior MLT) or their designated lab personnel (from other lab ) annually
   • OSH Representative/Officer
     • according to section 8 of the OSH Act, all employers must, where reasonably practicable, provide & maintain a safe, healthy working environment that is without risk to employees
     • thus, employers can appoint a representative in controlling & monitor occupational health & safety aspects of their employees & working stations
     • the main role of a safety officer is to act as a focal point for all Occupational Health & Safety matters arising in a lab
     • deputy safety officer may also be appointed to share the responsibilities of the role and to act in absence of safety officer

8. method evaluation