FINALS: LABORATORY QUALITY • Assesses how well the laboratory workflow is

MANAGEMENT SYSTEM functioning

LABORATORY QUALITY QUALITY MANAGEMENT SYSTEM

• Accuracy, reliability, and timeliness of • Encompasses all management activities
reported results needed to ensure that the laboratory workflow
• Challenge: reduce the level of inaccuracy as proceeds smoothly to provide laboratory
much as possible services to the patients
•Errors: unnecessary treatment, treatment • Includes Quality control (QC), Quality
complications, delay in diagnosis, additional assurance (QA), and all necessary
and unnecessary diagnostic testing management activities
• Need: perform all processes and procedures
in the lab in the best possible way PRINCIPLES OF QUALITY MANAGEMENT
SYSTEM

• Organization
• Customer Focus
• Facilities and Safety
• Personnel
• Purchasing and Inventory
• Equipment
• Process Management
• Documents and Records
• Information Management
• Nonconformance Management
QUALITY CONTROL • Assessment
• Target: accurate results • Continual Improvement
• Samples with known expected results are
tested before or along with patient samples ORGANIZATION
• If the expected QC results are obtained • Relationship among lab personnel
- All the patients' unknown results are • Link to hospital or parent organization
likely to be accurate • Lab links to the organization's quality function

NOTE: QC only targets the analytical part of CUSTOMER FOCUS

the workflow
• Requirements for the type and frequency of
QC
- Specified in operation manuals,
package inserts, and regulation
standards
QUALITY ASSURANCE
• A set of planned actions to provide
confidence that processes are working as
expected
• Answers the question: How does the
laboratory know it is delivering a high-quality
service to its customers?
• Who are the customers of the laboratory?
Patients
Physicians
Nurses
Lab staff: internal customers
FACILITIES AND SAFETY
EVERYONE IN THE LAB IS RESPONSIBLE
FOR QUALITY AND SAFETY
• Contact between the public and
biological specimens can occur only in
the rooms where patient samples are
collected
• Access to rooms where analysis is
performed or hazardous chemicals are
stored must be restricted to authorized
persons
 Doors, locks. staff ID

• Most efficient design: all related

services should be located in close
proximity
• Ensure that patients and patient
samples do not have common pathways
• The reception desk where incoming
patients register should be located as
close as possible to the entry door.
• If both the reception and the sample
collection room are located at the
entrance saves time and energy.
• If possible. circulation pathways of
clean and dirty laboratory materials
should never cross, and circulation
pathways of contaminated waste should
be isolated.
• Delineation of lab activities
 Single room or with bench space

• Location of service rooms (autoclaves.

sinks, media preparation)
 Central area (one main area where
the machines that aren't used
regularly are located)

• Consider the need for a stable power

supply for sensitive equipment and a
backup power supply or emergency
generator for times when the laboratory's
primary power source is down.
•Active ventilation systems
• High ceiling: washable glossy paint
• Work bench must be easy to clean and
resistant to deterioration
 Better if ceramic tiles

• Microbiology: separate benches for

different pathogen types
 To prevent cross-contamination

• Clean benchtops every after

examination and if there are spills
• Weekly cleaning: ceilings, walls
• Monthly cleaning: refrigerator. storage
areas