LABMAN: MLS 027 (SAS 17-20)

Lab Safety Begins Before You Go to the Lab!

OSHA PATHOGEN REGULATIONS

1. UNIVERSAL PRECAUTIONS
- a policy of treating ALL blood, tissue, body fluids and OPIM (other potentially infectious
materials) as INFECTIOUS

2. ENGINEERING AND WORK PRACTICE CONTROL

- involve taking physical steps to isolate or remove any possible pathogen hazards from the
workplace
Examples:
● Sharps’ containers
● Biological safety cabinet
● Laboratory fume hoods
● Proper hand washing and hand washing facility
● Banning of eating, smoking and drinking inside the laboratory

3. PERSONAL PROTECTIVE EQUIPMENT

(DONNING AND DOFFING)

4. HOUSEKEEPING TECHNIQUES
- must ensure that the workplace is maintained in a clean and sanitary condition.
Example: “Double-bagging” properly labeled with a warning and instructions for dealing with a
leak or spill.
METHODS OF WASTE TREATMENT
• Flushing down the drain to the sewer system
• Incineration
• Landfill burial
• Recycling

Incineration
preferred method for the waste treatment of hazardous chemical waste
flammable materials can also be burned in especially designed incinerators with afterburn and
scrubbers to remove toxic products of combustion

Landfill Burial
- the landfill site must be licensed to accept hazardous waste
- used for solid chemical waste that are unsuitable for incineration
- has caused environmental problem, shortage of safe site

Recycling
- for solvents such as xylene and acetone that can be filtered or redistilled for reuse
- for papers either scratch or scrap and sold to scrap buyers

COMMON WARNING SYMBOLS

QUALITY ASSURANCE

LABORATORY QUALITY
can be defined as accuracy, reliability and timeliness of reported test results
laboratory results must be as accurate as possible, all aspects of the laboratory operations must
be reliable, and reporting must be timely in order to be useful in a clinical or public health setting
in order to achieve the highest level of accuracy and reliability, it is essential to perform all
processes and procedures in the laboratory in the best possible way.

Factors that must be addresed ot asure quality in the laboratory

● the laboratory environment
● quality control procedures .
● communications
● record keeping
● competent and knowledgeable staf
● good-quality reagents and equipment

If inaccurate results are provided, the consequences can be very significant, including:
● Unnecessary treatment
● treatment complications
● failure to provide the proper treatment
● delay ni correct diagnosis
● additional and unnecessary diagnostic testing
 Process control
● refers to control of the activities employed ni the handling of samples and examination
processes ni order to ensure accurate and reliable testing
QC
● monitors activities related to the examination (analytic) phase of testing

The goal of QG
● is to detect, evaluate, and correct errors due to test system failure, environmental
conditions or operator performance, before patient results are reported

Quality control (QC)

● is a component of process control, and is an essential element of the quality
management system
● It monitors the processes related to the examination phase of testing and allows for
detecting errors in the testing system
● gives the laboratory confidence that test results are accurate and reliable before patient
results are reported
Steps for implementing and maintaining a QG Programme include:
● establishing written policies and procedures, including corrective actions
● training all laboratory staff
● ensuring complete documentation
● reviewing quality control data

QUALITY ASSURANCE: TYPE OF QUALITY CONTROL

TYPES OF QUALITY CONTROL

INTERNAL QC
- is compost of the operational techniques used by the laboratory staff for continuous
assessment of the quality of the results of individual analytical procedures
- a set of procedures for continuously assessing laboratory work and the emergent results

EXTERNAL QC (INTER-LABORATORY CONTROL)

- control samples that do not come with the test kit
- they are provided by an external source such as the regional
reference laboratory or a commercial supplier
- this type of control should also be tested in the same manner as you would test a patient or
client specimen
- carried out periodically and checked by the laboratory responsible for the monitoring system
Quality control samples
quality control samples should be treated in the exact same manner as the test samples and are
used to validate the test run

each laboratory should develop a criteria for run acceptance based on guidance from the
manufacturer's kit insert and in-lab validation of an external QC sample

Kit Controls - the negative and positive control provided with the kit

Quality Control Sample - a low positive externally produced sample

Reagent QC
each day of use, the technologist must confirm that the reagents react as expected when used
as described in the laboratory's procedure manual

Equipment Control Measures

A system of equipment control should include:

- a suitably maintained equipment register and supporting records
- procedures for the provision of adequate quantities of suitable equipment to meet the
established requirement
- a means of repairing equipment with the least possible delay
- clear operating instructions where applicable
- procedures to monitor the viability of equipment repair

Controls are implemented to avoid following equipment management problems:

- non-registration of equipment
- stockpiling of equipment (retaining replaced equipment unnecessarily)
- unauthorized ordering of equipment
- excessive usage of equipment
- unauthorized use of equipment

SIX SIGMA

Six Sigma stands for 6 standard deviations (6σ) between average and acceptable limits

is a disciplined, statistical-based, data-driven approach and continuous improvement

methodology for eliminating defects in a product, process or service

can also be thought of as a measure of process performance is a set of techniques and tools for
process improvement
• SIX SIGMA QUALITY CONTROL
- uses a variety of tools and statistics to not only find the problem quickly, but also to fix it and
continue to monitor it
- controlling problems produces higher customer satisfaction and can reduce unnecessary costs
for a company
- they create the highest level of product quality while still meeting goals and objectives
- is used as it describes a target of 3.4 defects per million opportunities which is considered to
be world class
- Sigma is the term given to a measure of deviation in a data set

• The tools are applied within a simple performance improvement model known as
Define-Measure-Analyze-Improve-Control, or DMAIC
• D – define the goals of the improvement activity
• M – measure the existing system
• A – analyze the system to identify ways to eliminate the gap between the current performance
of the system or process
and the desired goal
• I – improve the system
• C – control the new system

LICENSURE AND PROFICIENCY TESTING

Proficiency Testing
- is a means of assessing the ability of laboratories to competently perform specific tests and
measurements
- an important means of quality
- one of the best ways for an analytical laboratory to monitor its performance against its own
requirements and the norm of other laboratories, is to participate in it regularly
- it helps highlight repeatability and reproducibility performance of the laboratory

Calibration
- is a comparison between measurement devices one of known magnitude or correctness
(standard reference material) and another made in a similar way (test instrument or unit under
test)
- regular internal and external calibration checks must be performed on equipment (pipettes, pH
meter

Three Phases of Laboratory Practice

● Pre-Analytical Strategies
● Analytical Strategies
● Post Analytic Strategies
Classification of Clinical Laboratories

Classification by ownership

• Government - operated and maintained, partially or wholly, by the national government, a

local government unit (provincial, city or municipal), any other political unit or any department,
division, board or agency thereof

• Private - Owned, established and operated by any individual, corporation, association or

organization

• Classification by Function

• Clinical Pathology - includes Clinical Chemistry, Hematology, Immunohematology,

Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics,
Toxicology and Therapeutic drug monitoring and other similar disciplines

• Anatomic Pathology - includes surgical pathology, Immunohistopathology, Cytology, Autopsy,

Forensic Pathology and Molecular Pathology

• Classification by Institutional Character

• Institution based - a laboratory that operates within the premises and as part of an institution
such as but not limited to hospital, medical clinic, school, medical facility for overseas workers
and seafarers, birthing home, psychiatric facility, drug rehabilitation center

• Free-Standing - a laboratory that does not form part of any other institution

General Clinical Laboratory

Primary Category - Provides the folowing mnimi um service capabilities:

Hematology (complete blood count) includes hemoglobin mas concentration, Erythrocyte

volume fraction (hematocrit), Leukocyte number concentration W( BC count), and Leukocyte
type number fraction (diferential count)
Qualitative Platelet Determination Routine Urinalvsis
Routine Fecalysis
Blood typing (for hospital based)
Secondary Category- provides the minimum service capablities of aprimary category
laboratory plus the folowing:
Routine Clinical Chemistry- includes blood glucose substance concentration, Bolod uric acid
concentration, Blood creatinine concentration, Blood total cholesterol concentration
Quantitative Platelet determination
Crossmatching for hospital based
Gram staining for hospital based
KOH for hospital based

Tertiary Category - Provides the minimum service capabilities of a secondary category

laboratory plus the folowing.
Special Chemistry
Special Hematology including coagulation procedures
Immunoloav( culture and sensitivity)

Limited Service Capability (for institution based-only)

– provides the laboratory tests required for a particular service in institutions such as but not
limited to dialysis centers and social hygiene clinics.

Special Clinical Laboratory

- a laboratory that offers a highly specialized laboratory services that are usually not provided
by a general clinical laboratory.

Accreditation of clinical laboratories in the Philippines started with the passage of the clinical
laboratory law in 1965 through the Bureau of Research and Laboratories (BRL) which is
referred to as the Bureau of Health Facilities at present.