LABORATORY QUALITY

MANAGEMENT SYSTEM

2 – Facilities and Safety

1
 LEARNING OBJECTIVES

At the end of this module, participants will be able

to:
• relate how facility design impacts the efficiency and safety
of laboratory workers
• describe practices to prevent or reduce risks
• list personal protective equipment (PPE) that should be
used routinely by laboratory workers
• explain general safety requirements for the laboratory
• describe steps to take in response to emergencies such
as biological or chemical spills, or laboratory fires

2
SCENARIO

Your laboratory specializes in virology.

There is an epidemic of H5N1 in your
country and the Ministry of Health names
your laboratory as the reference laboratory
for processing all samples.

What are the elements to consider

ensuring biosafety in your laboratory?
3
The Quality Management System

Organization Personnel Equipment

Purchasing Information
Process
& Management
Management
Inventory

Non-
Documents conforming
& Assessment
Event
Records Management

Continual Customer Facilities

Improvement Focus &
Safety

4
Laboratory Accident

6
SECONDARY EFFECTS OF A LABORATORY
ACCIDENT

• loss of staff confidence

• loss of reputation
• loss of customers
• increased costs litigation, insurance

Negligence
of laboratory safety is costly!

6
 EVERYONE

is responsible for quality and safety

7
 All diagnostic
and health care
laboratories
must be designed
and organized for
Biosafety level 2
or above

8
LABORATORY DESIGN

• Path followed by the sample

• reception and registration of patients
• sampling rooms
• dispatch between different laboratories
• analysis of samples

• Report delivery, filing

• Service rooms

9
 Common room,
LABORATORY ABC stairs to offices

Gynaecological
Blood clotting samples

Blood
samples
Hematology

Wash
room
Biochemistry

Disinfection

Bacteriology

10
Registration desk

11
Safety during
service
no unauthorized persons
no friends
no children
no animals
Please
CLOSE
the DOOR

12
Sample collection room

13
 Common room,
LABORATORY ABC
stairs to offices

Gynaecological
samples
collection
Blood
clotting
Blood samples
collection
Hematology

Wash
Biochemistry room

Patient

Reception

Disinfection

Bacteriology

14
 Common room,
LABORATORY ABC stairs to offices
Gynaecological
samples
collection
Blood clotting

Blood
samples
Hematology
collection

Wash
Biochemistry
room

Sample
Reception

Disinfection
Bacteriology

15
SEGREGATED AREAS

16
STOCK ROOM

17
18
Doors and large equipment

Main
Door

19
 Common room,
LABORATORY ABC
stairs to offices

Gynaecological
samples
Blood collection
clotting
Blood
Hematology samples
collection

Wash
Biochemistry room

Waste

Reception
Disinfection
Bacteriology

20
PREMISES
• high ceiling with good ventilation
• walls and ceiling
• use washable, glossy paint
• easy to clean and disinfect
• floor
• easy to clean and disinfect

21
BENCH TOPS

• non-porous covering, easy to clean, resistant to

chemicals and disinfectants
• no wood, no steel

22
Benches and working space

23
SCHEDULED CLEANING

• daily
• bench tops
• floors
• weekly
• ceiling and walls
• other
• refrigerators
• freezers
• storage areas
• record date and cleaning staff
24
SAFETY MANAGEMENT

• Responsible: Safety Officer

• Safety Manual: laboratory-specific
• Standard Operating Procedures
• Trained personnel
 potential risks
 safety procedures
• Waste Management
25
GENERAL SAFETY EQUIPMENT

shower
eye washer fire safety PPE

waste disposal
26
STANDARD SAFETY PRACTICES
DO NOT-

27
STANDARD SAFETY PRACTICES
DO-

28
SAFETY SIGNS

29
30
 Research Employee Injuries
(1993–1997)

Howard Hughes Medical Institute, Office of Laboratory Safety

32
 Laboratory Support Injuries
(1993–1997)

Howard Hughes Medical Institute, Office of Laboratory Safety

33
LABORATORY HAZARDS

• physical
• chemical
• biological

33
 needles,
syringes

Bites, broken
scratches glass,
animal or
ectoparasites
Accidents, sharps
injuries

Aspiration
Spills,
through
sprays pipettes
34
PHYSICAL HAZARDS

35
Needles, Broken Glass, and Sharps
• do not recap needles
• always use puncture-resistant, leakproof,
sharps containers
• always use specific waste disposal
containers
• never directly handle broken glass

36
Do you see anything wrong?

38
Do NOT reuse disposable injection equipment

39
CHEMICAL HAZARDS

Biosafety Level 1 and 2 laboratories

Separate cabinets for storage:

 spill containment cabinet

 hazardous waste storage
 flammable liquids storage

39
MATERIAL SAFETY DATA SHEET

40
THE RISKS FOR LABORATORY WORKERS
-MOST FREQUENTLY REPORTED INFECTIONS IN US, 1979-1999

Disease or Agent No. of Cases

Mycobacterium tuberculosis 223
Q fever 176
Hantavirus 169
Hepatitis B virus 84
Brucella sp. 81
Salmonella sp. 66
Shigella sp. 56
Hepatitis non-A, non-B 28
Cryptosporidium sp. 27
Total 1074

41
BIOLOGICAL HAZARDS
AEROSOLS AND DROPLETS ARE THE MAIN
SOURCES OF CONTAMINATION

42
CONTAMINATION ROUTES

Ocular invasion

Inhalation

Ingestion

Skin penetration

43
PERSONAL PROTECTIVE EQUIPMENT
BSL 1 and 2
 laboratory coat
 gloves
 goggles or face shield
 masks
 hearing protection

44
Chemical Spills
 anything beyond a minor spill
and requiring help from outside of
the laboratory group constitutes a
major spill
Minor spill

Major spill
47
Biological Spills

Spill Exercises

Spill
Exercises

48
Laboratory Fire Safety
Learn how to operate a portable fire
extinguisher

49
SUMMARY

When designing a laboratory or

organizing workflow, ensure that patients
and patient samples do not have
common pathways.

48
SUMMARY
Safety is dependent on:
 a responsible supervisor
 a safety manual and SOPs
 trained personnel
 assessment of risks
 laboratory design

49
 KEY MESSAGE

Neglecting laboratory safety is costly.

It jeopardizes the lives and health of

employees and patients, and jeopardizes
laboratory reputation, equipment, and
facilities.

Reference: ISO 15190

50
 Organization Personnel Equipment

QUESTIONS?
Purchasing Information
Process
& Management
Management
Inventory
COMMENTS?
Non-
Documents conforming
& Assessment
Event
Records Management

Continual Customer Facilities

Improvement Focus &
Safety

FACILITIES AND SAFETY - MODULE 2

51
CLSI V 2015