PowerPoint Presentation to Accompany

Phlebotomy:

A Competency-Based
Approach
Booth and Mundt
 11-2
Chapter 11
Quality Assurance

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 11-3

Upon completion of this chapter, you should

be able to:

Describe the system for monitoring quality assurance

in the collection of blood specimens.
Identify policies and procedures used in the clinical
laboratory to assure quality in obtaining blood
specimens.
Carry out documentation of quality control.
Identify corrective actions for failures of quality control.

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 11-4

Maintaining Quality (LO 11.1)

Quality
State of excellence
Free from defects or deficiencies

Accomplished by adhering to set of

measurable standards
Ensures patient safety and customer
satisfaction

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 11-5

Quality in the Laboratory (LO 11.1)

Proper completion of lab requisitions

Competent specimen collection
Correct specimen processing
Accurate performance of tests
Correct reporting of results

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 11-6

Accuracy and Precision (LO 11.1)

Actual glucose level: 125 mg/dL
Results both accurate and precise:
122 mg/dL
127 mg/dL
125 mg/dL
126 mg/dL
122 mg/dL
124 mg/dL
125 mg/dL
120 mg/dL
127 mg/dL

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 11-7

Accuracy and Precision (LO 11.1)

Actual glucose level: 125 mg/dL
Results precise, but not accurate:
100 mg/dL
102 mg/dL
90 mg/dL
95 mg/dL
101 mg/dL
98 mg/dL
95 mg/dL
103 mg/dL
100 mg/dL

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 11-8

Accuracy and Precision (LO 11.1)

Actual glucose level: 125 mg/dL
Results neither accurate nor precise:
162 mg/dL
135 mg/dL
126 mg/dL
102 mg/dL
124 mg/dL
85 mg/dL
150 mg/dL
117 mg/dL

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 11-9
Total Quality Management
(TQM) (LO 11.1, LO 11.2)
Highest level of quality oversight
Managed at organizational level
Governs behavior of a set of individuals

Identification of the organizations

customers
Designs operations to produce highest
customer satisfaction
Not just accuracy of test results

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 11-10

Patient Satisfaction (LO 11.1, LO 11.2)

General factors
How long they had to wait for the procedure
Presence or absence of bruising at the site

How many needlesticks were required

Perception of phlebotomist
Attitude
Appearance

Communication skills

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 11-11
Quality Cost Management
(QCM) (LO 11.1, LO 11.2)
System to measure and manage cost of
quality
Cost of quality includes
Cost of repeating tests when results are
questionable
Cost of correcting errors in a process

Cost of maintaining customer satisfaction

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 11-12
Quality Management System
(QMS) (LO 11.1, LO 11.2)
Establishment of
Quality objectives
Methods to monitor achievement of
objectives
Organizational structure of laboratory
Procedures, processes, and resources

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 11-13

Quality Assurance (QA)

(LO 11.1, LO 11.2)

Examining performance of a process to

confirm that
Testing is performed correctly
Results are accurate

Mistakes are found and corrected

Standards put in place

Focuses on overall process to measure
patient outcomes

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 11-14

QA in the Laboratory (LO 11.1, LO 11.2)

Ordering and Turnaround time

requisitioning tests Personnel training
Positive patient ID Proficiency testing
Collection processes Laboratory
Integrity of specimen inspections
Test analysis Documentation and
processes follow-up on
Results reporting corrective action

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 11-15

QA Chain of Accountability
(LO 11.1, LO 11.2)

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 11-16

Quality Control (QC) (LO 11.1, LO 11.2)

Evaluates each procedural step for

accuracy
Each step must meet acceptable standards
or parameters (limits)
Detects variances from standard
operating procedure (SOP)

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 11-17

QC Activities (LO 11.1, LO 11.2)

Calibration
Initial check before using new equipment
Periodic check to maintain settings

Control substances
Used for calibration and system checks
Check expiration date before using

Validation
Delta check

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 11-18

QC Activities (LO 11.1, LO 11.2)

TQM
(Including QCM)

Lab QMS

QA Nursing
QA
Pre-examination
Examination
phase
QMS
phase
QC QC
QC QC
QC QC
QC
QA
Other
Post-examination
phase
Departments
QC
QMS
QC

Chapter 11

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 11-19

Apply Your Knowledge

(LO 11.1)

What is the name of the highest level

in the hierarchy of processes used to
achieve quality in the laboratory?

Answer: Total quality management

(TQM).

GOOD JOB!

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 11-20

Apply Your Knowledge

(LO 11.2)

Name two quality control activities

that phlebotomists perform.

Answer: Checking expiration dates on

phlebotomy equipment, recording
temperatures, calibrating centrifuges,
double-checking individual steps in the
specimen collection process.
GREAT!

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 11-21
Documenting Quality Control
Activities (LO 11.3)
QC documentation required
QC tests for each analyte tested on each
instrument
Actions taken to remedy variances

Initialed by person performing QC

Reviewed and signed by supervisor

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 11-22

Quality Control Record (LO 11.3)

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 11-23

Levy-Jennings Chart (LO 11.3)

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 11-24

Quality Control Results (LO 11.3)

Systematic errors
Trends
Shifts

Random errors
Operator procedural error
Equipment failure

Outdated reagents

Clerical errors

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 11-25

Quality Control Results (cont.)

(LO 11.3)

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 11-26

Temperature Control Logs

(LO 11.3)

Specific temperature requirements

Specimens and reagents
Refrigerators and freezers

Incubators and water baths

Testing procedures

Some laboratory rooms

Daily temperature logs

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 11-27

Temperature Control Logs (cont.)

(LO 11.3)

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 11-28

Apply Your Knowledge

(LO 11.3)

Why must phlebotomists or laboratory

personnel record refrigerator and freezer
temperatures daily?

Answer: To ensure that specimens are

being stored at the required temperatures.

GOOD JOB!

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 11-29
Quality Assessment and
Process Improvement (QAPI) (LO 11.4)
Audits to discover process weaknesses
Records reviewed
Incident forms examined

Improvements implemented
Corrective action
Preventive action

Results monitored

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 11-30

Competency (LO 11.4)

Ability to perform assigned tasks

correctly
Competency assessment
Documents employees competency
Kept in employee files

May reveal need for training

Often required for inspections

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 11-31

Proficiency Testing (LO 11.4)

Proficiency testing (PT)
Laboratory performance evaluation
Comparison with other, similar laboratories

Testing agencies
College of American Pathologists (CAP)
Department of Public Health (DPH)

Centers for Disease Control and

Prevention (CDC)
Other agencies

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 11-32

Apply Your Knowledge

(LO 11.4)

What is the purpose of a QAPI

committee?

Answer: Review documentation to

discover and eliminate weaknesses in a
process.
GREAT!

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 11-33

Chapter 11 Summary
Systems exist for monitoring the quality
of laboratory procedures.
Quality assurance processes include
assessment and evaluation of all steps in
a procedure.
Quality control is the activity that ensures
that specific steps in a procedure meet
performance standards.

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 11-34

Chapter 11 Summary (cont.)

Accurate documentation of all quality
assurance and quality control activities is
essential for monitoring quality.
Quality assessment and process
improvement (QAPI) provides a system
for error detection and correction to
ensure patient satisfaction, valid test
results, and accurate reporting of results.

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