IBTS - Environmental Monitoring Flashcards
Why is EM important?
To ensure that the environment in which the products are produced has a reduced risk of contamination
What does EM do in the IBTS
Carry out tests which count the bioburden on surfaces and in the air
This allows the IBTS to spot and track trends e.g. seasonal bacteria etc
Collecting this data allows for corrective action and prevention methods e.g. retraining a staff member associated with bacterial contamination
What are the four types of trends seen
Shift (temporary) e.g. once off contamination by E.Coli
Shift permanent e.g. increased contamination associated after hiring new staff member
Cyclical e.g. seasonal contamination
Drift e.g. as months get warmer etc
What products is EM particularly vital for?
Transplantation of sterile cells and tissues e.g. Heart valves and stem cells
Information on EM is required in order for the cells/tissues to be released for transplantation
Who might look for EM info during audits and why might they require these?
The Health Products Regulatory Authority might look for EM data to ensure nothing unexpected occurred during processing, and that there is compliance with the regulations
e.g. heart valves cannot be released without certification that the cleanroom is within spec
Where is EM carried out in the IBTS
Collection clinics -> donor arms, equipment, fridges etc
Cleanrooms -> blood processing equipment
Blood storage and issue areas
What does MODA do>
Used to keep track of EM samples e.g. plan scheduling EM, acquisition of samples, incubation, result entry etc
What is the LIS management system used for EM in the lab
MODA -> Laboratory information management system
How do we monitor the blood donation clinic
Apheresis clinic monitored on a 4-week rotation where different beds/locations are monitored
Normal clinics monitored monthly and equipment is rotated etc
Venepuncturists carry out a competency check every 6 months
We will carry out a bacterial check on the donors arm post disinfection of the donor site -> assuring VP is trained correctly
How is the donors arm disinfected
We use Chloraprep or Frepp
Both contain 1.5mls of 2% chlorohexidine gluconate (IPA)
What is the acceptance criteria for EM on the donor’s arm
,5 Colony forming units on 95% of the arm
What are the main sources of contamination in cleanrooms?
Surfaces, Equipment and Water - 10%
Air -15%
Personnel - 75%
How can personnel contaminate cleanrooms?
Skin flakes, hair, cosmetics, bacteria, viruses, skin cells, cellulose fibres from clothes etc
How do we control our clean rooms
We do so by minimising the generation and retention of particles in the room using several different methods depending on the grade of sterility of the room
How do we grade cleanrooms
Grade A - cleanest to grade D being a normal laboratory room
Give some ways of maintaining a cleanroom
Hand washing & hygiene
Tacky mats - Dycem mats
Gowning and behaviour of staff
Cleaning/use of sterile materials
Design of the room/regular cleaning etc
Heating, Ventilation, Air conditioning systems (HVAC)
How does HVAC differ in a grade A/B lab than in a grade D/C
Turbulently ventilated in a grade D/C
Laminar flow/unidirectional in a grade B/A
How our the grade D labs controlled in the IBTS (not normal hospital)
Non sterile garments e.g. labcoat
Blue scrubs
Mobcap
Gloves
Lab coat
Lab safety shoes/shoe covers
How do we control a grade A/B lab
Sterile garments - spacesuit scrubs
y-irradiation sterilised:
- boots, hood, suit, long sleeved tunic, face mask and gloves
- goggles and socks (yellow) also introduced
- staff must be recertified every 6 months
How are the different labs in the IBTS graded
Production = grade D
Tissue bank;
- depending on area (grade A, B and D)
- Cryobiology: (grade A, B and D)
