August 25, 2022

Role of laboratory in healthcare

1. Detect disease or predisposition to disease1
2. Confirm or reject a diagnosis
3. Establish prognosis - prognosis is the development of a disease
4. Guide the patient management
5. Monitor efficacy of therapy

What is management?
This is the implementation of the four conditions that must be present for management to
succeed
1. mission
2. authority
3. resources
4. accountability

The importance of lab quality

Lab quality can be defined as accuracy, reliability, and timeliness of the reported test results.

Negative Consequence of lab error

1. unnecessary treatment; treatment complications
2. failure to provide the proper treatment
3. delay in correct diagnosis
4. additional and unnecessary diagnostic testing

Complexity of laboratory processes

A method of detecting errors at each phase of testing is needed if quality is to be assured.
Three phases of lab processes:
1. Pre Examination/Pre-analytical
2. Examination/Analytical
3. Postexamination/Post-analytical

PSEUDOHYPERKALEMIA - false increased in potassium

Order of Draw
B - blood culture
C - citrate
N - non-additive
H - heparin
E - EDTA
S - Sulfur Fluoride
Path of Workflow
Pre-examination: The Patient - Test Selection - Sample Collection - Sample Transport
Examination: Laboratory Analysis
Postexamination: Report Creation - Report Transport - Result Interpretation

Quality Systems Management - coordinated activities to direct and control an organization

with regard to quality.

Organization
Personnel - most important resource in lab is a competent, motivated staff
Equipment - must have the right equipment, equipment is working properly,
Purchasing and Inventory - proper management of purchase and inventory of supplies,
supplies and reagents are always available
Process control - comprise of several factors that affect quality control
Information management - HIS, laboratory information system. Everything must be
documented. Ensures accuracy and confidentiality as well as accessibility to the laboratory staff
and to other healthcare professionals.
Documents and Records - Documents are needed in the laboratory to inform how to do things,
and laboratories always have many documents. Records must be meticulously maintained, so
as to be accurate and accessible.
Occurrence Management - error or occurrence that should never happen
Assessment - involves comparing laboratory performance to internal standards for quality or
external data sets, such as industry benchmarks. Assessments include the activities of lab or
QC managers, internal auditors, or external inspectors.
Process improvement - there's always room for improvement; continuous improvement
Customer Service - feedback of the customers are important in providing process improvement
Facilities and Safety - security, containment, safety, ergonomics

Biosecurity is the prevention of disease-causing agents entering or leaving any place where
they can pose a risk to farm animals, other animals, humans, or the safety and quality of a food
product. Protecting the bad bugs from bad people.
Bioterrorist - bad people using bad bugs to cause harm to other people.
Biosafety - includes the procedures and policies to prevent harm to the people. process to
protecting people from

September 1, 2022
Quality Assessment and Performance Improvement
1. Define Quality
2. Analyze past quality management
3. Decide and Implement a quality management program

Quality Control (QC) and Quality Assurance (QA)

Quality Control is the application of statistical methods to the evaluation of quality products and
services. Before products are released to the market they should undergo quality control.
application of statistical methods
Quality Assurance is the program in which the overall activities conducted by the institution are
directed toward assuring the quality of product and services provided. QC is under QA

Total quality management (TQM)

quality management program that includes each component in the creation process, from the
acquisition of supplies to active follow up after product or service has been received by a
delighted customer
one of the programs used in quality assurance //

Continuous quality improvement (CQI or PQI (Performance quality improvement

process of creating an environment in which management and workers strive to create
constantly improving quality
Assess procedures, processes, in the lab. plan the improvement and implement improvement.

Major figures in quality management

Philip Crosby - started quality management, quality is free, poor quality is expensive. Quality is
a strategic imperative that can be quantified and put into the bottom line. zero defects,
companies should not allow defects as an in-built expectation
W.Edwards Deming - TQM thinker or is the management thinker. helped Japan's recovery after
the second world war. allows individuals to plan and continually improve their products and
services. founded japanese products quality together with juran. formulated many principles with
quality management. 14 points for management. seven deadly diseases of quality management,
pedce cycle.
Joseph Juran - initiate CQI, quality is a continuous improvement process. Requires managers
pursuit for setting and achieving goals for CQI. Pareto rule. Pareto rule or principle is also
known as the 80-20 rule. It is widely popular because it can be applied in all aspects of life. It
states that 80 percent of problems arise from the 20 percent of trouble points. or 80% of output
is a result of a 20% input.
James O. Wrestgard - really helped many lab technicians in quality management. Westgard
rule used in maintaining the quality assurance program. also known as westgard rule or
multi-rule system.

Quality management started in manufacturing business

quality, most frustrating part of management

Quality assessment and improvement - a quality management program that focuses on the
success of the organization in designing and achieving its set goals and objectives.
Basic quality control statistics
accuracy closeness of the result to the true value of an analyte when running a test. "hitting the
bullseye"
precision is the reproducibility. how well a procedure reproduces a value.
population describe and define the item being studied in a particular time
sample part of a population, used t analyze the characteristic of the population
gaussian distribution term that describes wherein the mean
Standard deviation (SD) measurement of precision, tendency to cluster, center, scatter around
the mean.
(CV) Coefficient of variation, SD percentage of the mean
Control Chart a chart used to plot control measurements against standards
Run charts, line graphs used to display data over a period of time.

Specialized laboratory data evaluation methods

Levey-Jennings, LJ Chart -control chart used to plot previously set limits(procedures) is in or
out of control values.
Multirule analysis - westgard rules

Internal Quality Assessment Programs

Involves running of control materials into every run of analysis in the laboratory before testing
the patient samples. Results are plotted on control charts, if laboratory results fall outside the
range, the measurement system must be checked and corrective action must be taken or
implemented.
External Quality Assessment Programs
lab participation voluntary or mandatory initiated through the laboratory community. PURPOSE:
Proficiency testing/ accreditation/licensure activities in the hospital programs.

1. NEQAS/EQAS
National reference laboratory (NRL) // sections
Lung center of the Philippines Clinical chemistry
National Kidney Transplant Institute Hematology
Research Institute for Tropical Medicine Microbiology and parasitology
San Lazaro (SACCL) Immunoserology
East Avenue medical center Drug testing

Partner NRL should assess every lab in the country

Way for DOH to check the quality of a laboratory
Samples are provided by the NRL

Element of quality control program

written policies and procedures
training all laboratory staff
documentation
reviewing quality control data
Implementation process
1. Establish policies and procedures
2. Assign responsibility for monitoring and reviewing
3. train all staff on how to properly follow policies and procedures
4. select good quality control material
5. establish control ranges for the selected material
6 develop graphs to plot control values; these are called levey-jennings charts
7. establish a system for monitoring control value
8. take immediate corrective action if needed
9. Maintain records of quality control results and any corrective actions taken

Control materials - substances that contain an established amount of the substance being
tested- the analyte. Quality control materials are run to quantify the variability and establish a
normal range, and to decrease the risk of error.

GCR Notes
What is Quality Control?
Monitors activities related to the examination phase of testing
Quality control is the part of quality management focused on fulfilling quality requirements (ISO
9000:2000[3.2.10]
The goal of quality control is to detect, evaluate, and correct errors due to test system failure,
environmental conditions or operator performance before patient results are reported.

QC for Varying Methods

Quantitative Examination
Measures quantity of analyte, measurement is in numeric value
Qualitative Examination
Measure presence or absence of a substance or evaluate cellular characteristics such as
morphology. Expressed in qualitative terms, positive/negative, reactive/non reactive, growth/no
growth, and normal/abnormal
Semi-quantitative Examination
In quantitative terms, not in numerical but in estimation

Elements of a QC Program
Establish written policies and procedures - includes corrective actions
Review QC data
Assure complete documentation
Train all staff

Control materials
Used in qc programs
Are substances that contain an established amount of the substance being tested-the analyte
Are tested at the same time and in the way as patient samples.