LABMAN SEMIS Flashcards
doing the right things right the first time; there is a degree, of excellence and customer satisfaction
Quality
Also describes as “the tools”.
Quality control
Relies heavily on quantitative statistical methods that focus on the final product as defined by the standards set by the producer
Quality control
It is how the company ensures the product quality
Quality control
The foundation of quality control
descriptive analysis or descriptive analytics / descriptive statistics
Systematic process that determines whether the service/product meet the specified requirement
Quality assurance
Developed out of the limitations of the quality controm-approach and defined quality in health care institutions by the success of the total organization, not just individual components of the system in achieving the goals of patient care
Quality assurance
To ensure that quality laboratory services are provided, every laboratory should strive to:
- Obtain modern equipment
- Hire well-trained staff
- Ensure a well-designed and safe physical environment
- Create a good management team
ultimately dispels the concept of “good enough” and promotes one of it can always be done better.
Quality Systems Management
Systems approach that focuses on teams, processes, statistics, and deliveries of services or products that meet or exceed customer expectations.
Total quality management
Continuous process to eliminate the errors in manufacturing
Total quality management
It mainly involves the continuous improvement of the organization processes
It is a continuous, customer-centered, employee-driven improvement
TQM
An element of TQM that strives to continually improve practices and not just meet established quality standards.
Continuous quality improvement
Process of creating an environment in which the management and the workers will strive to create constantly improving quality
Continuous quality improvement
Set of methodologies to improve the management process by reducing the defects/errors
Six sigma
indicates the frequency of defects occurring in one process
Sigma value
Ultimately designed to reduce waste (non-valued activities), which means to reduce cost by identifying daily work activities that do not directly to the delivery of laboratory services in the most flow efficient or cost-effective ways.
Lean
He Originated the PDCA (Plan-do-check-act) cycle, and introduced it to W.E. Deming
Walter shewhart
Deming promoted the PDCA cycle in what year
1950s
4 stages of PDCA cycle
Plan
Do
Check
Act
- The Father of Quality
- Established, the concept that quality is a continuous improvement process that requires manager’s active pursuit in reaching and setting goals for improvement.
Joseph Juran
One of Juran’s key quality principle that follows the observation of the economist Vilfredo Pareto
The Pareto principles (80/20 rule)
Used for laboratory quality control
Westgard’s rule
- Applied Shewhart’s multirule system to the evaluation of quality control data in the medical laboratory.
- He is internationally recognized Quality Control (QC) expert because he is the originator of the multirule (Westgard’s rule)
Dr. James Westgard
nearness or closeness of a result to the actual
value of the analyte when performing a test.
Accuracy
ability of an analytical method to give repeated results/reproduces a value.
Precision
distribution of errors from the analytical method, and occurs when the data can be accurately
described by the SD and mean
Gaussian curve
it calculates the difference between QC
results and the target means
Cumulative Sum Graph (CUSUM)
used to compare results obtained on a high and low control serum from different laboratories
Youden/Twin Plot
most commonly used chart and it is also referred to as S-L/J or dot chart
Shewhart Levey-Jennings Chart
rejection or warning rule used to identify or indicate if the analytical processes are out of control
Westgard Control Rules
refers to the control rule that is commonly used with a Levey- Jennings chart when the control limits are set as the mean plus/minus 2s
12s rule
may occur by chance at any time and place within the testing or service process
Random error
Causes of random errors are:
• bubbles in reagents or reagent lines
• instrument instability
• temperature variations
• operator variability, such as variation in pipetting
Examples of random errors are:
12S, 13S, and R4S or increased in precision
error that influences observations consistently in one direction
Systematic error
Sample of systematic errors
22s & 41s
Statistical tool used to measure the systematic error or accuracy
Mean
Statistical tool used to measure precision or dispersion of values around the mean
Standard deviation
Statistical tool that allows comparison and check on precision and variability of each method
Coefficient of Variation
formed by control values that either increase or decrease for six consecutive days
Trend
Main cause of trend
deterioration of reagents
formed by control values that distribute themselves on one side or either side of the mean for six consecutive days
Shift
Main cause of shift
Improper calibration of the instruments
THREE PHASES OF THE TESTING PROCESS
Pre-analysis
Analysis
Post-analysis
refers to all the activities that take place before testing, such as test ordering and sample collection.
Pre-analysis
consists of the laboratory activities that actually produce a result, such as running a sample on an automated analyzer.
Analysis
comprises patient reporting and result interpretation. Collectively, all of the interrelated laboratory steps in the testing process describe its workflow
Post-analysis
is an act regulating the operation and maintenance of clinical laboratories, and also requiring the registration of the same with the Department of Health providing penalty for the violation and other purposes
R.A. 4688 (The Clinical Laboratory Law of 1966)
Date of approval of R.A. 4688
June 18 1996
former agency assigned to ensure the health of the general public from substandard laboratories
Bureau of Research and Laboratories (BRL)
rules and regulation governing the establishment, operation, and (maintenance of clinical laboratories in the Philippines
Administrative order 59 s. 2001
It is the monitoring disease via examination of body fluids
Clinical pathology
Examples of clinical pathology based on AO 59 s. 2001
• Hematology
• Clinical Chemistry
• Microbiology
• Parasitology
• Mycology Clinical
• Microscopy
• Immunohematology
• Blood Banking
• Laboratory Endocrinology
• Toxicology and Therapeutic
Drugs Monitoring
It focuses on the examination of organs
Anatomic pathology
Examples of anatomic pathology based on AO 59 s. 2001
• Surgical Pathology
• Immunohistopathology
• Cytology
• Autopsy
• Forensic Pathology
The laboratory that operates within a hospital
Hospital-based
The laboratory that operates on its own
Non-Hospital-Based
operated and maintained partially or wholly by the national government, local government unit (provincial, city, or municipal owned), and any other political unit, department, division, board, or agency
Government
owned, established, and operated by any individual, corporation, association, or organization
Private
The 2 added clinical pathology based on AO 27 s. 2007
- molecular biology
- cytogenetics
Added in anatomic pathology based on AO 27 s 2007
Molecular pathology
The laboratory operates within the premises and as part of an institution, such as but not limited to hospitals, medical clinics, schools, medical facilities for OFWs and seafarers, birthing homes, psychiatric facilities, and drug rehabilitation centers
Institution-based
The laboratory does not form part of any other institution
Free-standing
a certification, usually by professional organizations, that designated standards have been achieved.
Accreditation
the organization complies with the highest national standards for safety and quality of care, and is committed to continually improving patient care
Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)
ensures the test results are meeting and exceeding industry standards for clinical laboratory testing
College of American Pathologist
international mark of excellence that demonstrates the facility’s commitment to quality and safety to patients, donors, regulatory agencies, and insurance companies
American Association of Blood Banks
the process of establishing qualifications to perform a duty or job, usually through the formal recognition of professional or technical competence to an institution or person as having met certain requirements or standards.
CREDENTIALING
refers to the process of establishing and declaring that a person has met the standards established by a professional organization.
CERTIFICATION
awarded to an individual once the issuing agency can objectively quantify that he or she is qualified to perform a job or task
Certification
does not give the holder a professional title
Certificate
can give the holder professional title
Credential
A cross-disciplinary area concerned with protecting the health and safety of people engaged in work or employment.
OCCUPATIONAL HEALTH & SAFETY
should be considered in the design and layout of the building
Safety factors
Most common local exhaust ventilation system in laboratory
Fume hoods
Infectious materials caused by microorganisms
Biological hazards
-any material, that could possibly become contaminated with blood; must be
treated as having potential to carry a pathogen transmitted by blood
Blood borne pathogens
Examples of blood borne pathogens
- malaria
- syphilis
- hepatitis b
- hiv
- hepatitis c
Primary method to reduce the risk of transmitting the infection
Wash hands
Items that are capable to cause wounds
Sharp hazards
the agency responsible for developing and enforcing regulations governing safety in the workplace
Occupational safety and health administration (OSHA)
a document required by OSHA detailing safety information about each hazardous substance
Material Safety Data Sheets
Person who are exposed to the radioactive hazard are required to wear
Film badge
Are used in the procedure of radioactive hazards
Radio isotopes
2 major hazards in the laboratory
Electrical & fire hazards
4 essential steps to take if you discover a fire
RACE ( Rescue, Alarm, Contain, Extinguish/Evacuate )
assigned to overall development and monitoring of safety management program
Safety committee
in charge with the implementation and day to day management of the safety program
Safety officer
any solid, liquid, semi-solid or contained gaseous material that is discarded, abandoned, recycled, or is an inherently waste-like material
Solid waste
are those that pose no immediate threat to human health and the environment
Non-hazardous wastes
originates from plant or animal sources, which may be broken down by other living organisms
Biodegradable waste
cannot be broken down by other living organisms
Non-biodegradable
potential threat to human health or the environment when improperly treated, stored, transported, and disposed.
Hazardous waste
It ensures that the environment and laboratory personnel will remain safe from acquiring disease and the waste
Waste management
Color of trash bin for dry & non infectious waste
Black
Color of trash bin for infectious waste
Yellow
Color of trash bin for wet & non infectious waste
Green
Color of trash bin for sharps
Red
In Administrative order 59 s. 2001, BRL is replaced by
Bureau of Health Facilities and Services (BHFS)
