quality management

quality

Meeting the predetermined requirements of the users of a particular service.

total quality management

An organization-wide approach to continuously improve the quality of laboratory processes and services.

• Monitors entire testing process

• Identifies causes and prevents recurrence

• Supports accurate, reliable, & timely results

• Ensure staff training & competence

• Promotes continuous improvement

what TQM accomplishes (5)

quality management system

Coordinated policies, processes, procedures, personnel, equipment, and resources used to ensure reliable laboratory testing

• quality policies and objectives

• documents and procedures (policy manual, procedure manual, standard operating procedure, work instructions)

• process management

• risk management

• customer focus

• measurement and analysis

• personnel involvement and competency

• supplied and inventoey management

• audits and compliance

• continual improvement

major components of quality management system

policy manual

states the organization’s commitment and direction regarding quality

policy manual

answers the questions like: “Why do we need to perform this process?”

, “What are our standards to achieve quality service and processes?”

“What is the commitment of this institution towards quality services and processes?”

procedure manual

Describes the overall process and responsibilities of a clinical laboratory or sections of a clinical laboratory.

procedure manual

Refers to the entire workflow of a certain section of a clinical laboratory.

standard operating procedure

It focuses on one specific procedure within a larger workflow

standard operating procedure

Provides standardized methods for performing one activity consistently, every time.

work instructions

• Gives a very specific guidance in performing a particular

test within the SOP.

• Most of the time, it contains diagrams or photos

SOP

Work Instruction

Example: Urine Microscopy

—: Mix the urine

—: Describe the proper way of mixing the urine specimen, and how many times it needs to be mixed

risk management

QMS identifies and controls potential problems that could affect laboratory

results’ quality or patient safety

quality assurance

Is the planned and systematic framework used to ensure that laboratory services meet defined quality requirements

quality assurance

It monitors the entire testing process, compares performance with standards, and uses feedback and corrective action to prevent errors

quality assurance

Set goals toward quality in services & processes

quality assurance

This section outlines the institution's obligations, commitments, and target objectives

quality assurance

Ensures that processes are suitable for their intended purpose and that quality requirements are met throughout the pre-examination, examination, and post-examination phases

Providing the result

(1) at the right time

(2) on the right specimen

(3) from the right patient

(4) with the correct interpretation

(5) based on the appropriate reference values

(6) at the right cause

6 goals of quality assurance

Continuous and ongoing

Preventive in nature

Covers all laboratory activities

Evaluates laboratory performance regularly

Focuses on overall quality improvement

characteristics of quality assurance

(CPCEF)

• Commitment from management and staff

• Adequate facilities and resources

• Competence, continuously assessed personnel

• Reliable procedures and methods

• Calibrated, maintained instrumentation

essentials of quality assurance

(CACRC)

quality assurance

monitors and evaluates the entire laboratory service . It ensures that processes are suitable for their intended purpose and that quality requirements are met throughout the pre-examination, examination, and post-examination phases

1. pre-examination

2. examination

3. post-examination

3 major phases of QA

pre-examination variables

These are the activities occurring before the actual laboratory testing

pre-examination phase

Most of the laboratory errors occur during the—

pre-examination phase

what phase does test selection and request belong

pre-examination phase

what phase does patient preparation and identification belong

• Patients misidentification

• Wrong test order

• Incorrect specimen

• Insufficient urine volume

• Delay transport of urine sample

• Improper preservation

Common Errors in Pre-examination (Pre-analytical) Phase

1. check the label of the specimen

2. ensure that the label on the request slip & on the specimen container correlate with each other

3. Evaluate the date & the time of the collection

4. Evaluate the sustainability of the specimen preservation if necessary.

5. Evaluate the acceptability of the specimen

general steps to observe in receiving urine specimen

pre-examination phase

what phase does specimen collection and labeling belong

pre-examination phase

what phase does specimen collection and labeling belong

a. complete patient name

b. birth date

c. hospital unique number

3 unique identifiers to check in label of urine specimen

quality control

Verifies that the analytical system (examination system) is stable enough to produce reliable patient results

examination phase

what phase does quality control focuses

quality control materials

These are materials with expected values that are tested alongside patients’ samples

quality control materials

Helps determine whether the testing system is functioning properly

quality control materials

Should have the same expected value, and composition as the patient specimen

assayed controls

The manufacturer provides target values and ranges

assayed controls

Are control materials that come with manufacturer assigned target values and expected ranges for analytes.

assayed controls

• There’s no need to do repeat testing to establish target values.

• Verify sustainability for the laboratory’s method

unassayed controls

• There was no target values and range provided

• Use repeated results obtained under stable conditions

unassayed controls

Repeated testing is required to establish mean and standard deviation, and to come up with acceptable control limits

levey-jennings control charts

Graphical tool used to monitor the performance of an analytical testing system (examination system) over time

levey-jennings control charts

Shows how each observed control results differ from the established mean of the control material

1. x-axis

2. y-axis

3. target mean

4. reference lines

components of LJ control charts

x-axis

[LJ control chart component]

• run number, date, or time

• Answer the question: “ when was our control tested?”

y-axis

[LJ control chart component]

• measured control value

• Answer the question: “ what control value was obtained?”

target mean

[LJ control chart component]

• central reference line

• Target value/expected value of control

reference lines

[LJ control chart component]

±1, ±2, and ±3 SD

trends

• gradual but continuous movement upward or downward.

• May reflect deterioration or instrument drift

shifts

• Sudden movement/abrupt change to a new operating level.

• Often fall on the same side of the mean

• May follow calibration, lot, temperature, or volume change

westgard rule

is a structured system for interpreting quality control results plotted on Levey-Jennings Chart

random errors

causes unpredictable variation in QC results.

systemic errors

causes errors to move consistently in one direction. They may appear as shifts or trends

1 2s

warning rule; inspect other control results

1 3s

reject when one result exceeds ±3 SD

2 2s

suggests systematic error

R4s

Suggests random error within a run

4 1s or 10x

suggests a persistent systematic change

calibrator

• Establishes the response-value relationship.

• It sets the measuring scale

control

• Independently monitors continued performance.

• It will check whether the measuring scale continues to measure correctly.

• Evaluates the equipment/instrument if it gives reliable & accurate results

precision

Is the closeness of the repeated measurements to one another and reflects reproducibility

accuracy

Is the closeness of a measurement to the accepted reference or true value.

post-examination phase

• These are activities or processes affecting results’ reporting and interpretation.

• Activities after the actual laboratory testin

post-examination phase

Ensures that results are accurately verified, reported to the correct recipient, interpreted appropriately, and retained according to laboratory policy

quality assessment

Evaluates how well the laboratory produces reliable results and whether its QA & QC activities are effective

quality assessment

It is a part of Quality Management, but it focuses on checking whether the quality system is in place, or whether all procedures and processes are standardized

quality assessment

Is a systematic evaluation of laboratory performance to determine if the established quality requirement, standards, and procedures are actually being checked

external assessment

• Proficiency testing/EQAS

• Interlaboratory comparison

• Evaluation of laboratory performance using an external organization (National Reference Laboratories) or comparison system.

• Laboratories are given unknown specimens

internal assessment

• Internal audits

• Split-sample or replicate testing

• Review of retained or repeated specimens.

• Done by supervisors or quality officers.

plan

select a problem using evidence and define a targe5

do

implement the proposed change

check

measure results with quality indicator

act

standardize success or revise the intervention