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Quality Control in Clinical Chemistry

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219 views2 pages

Quality Control in Clinical Chemistry

Uploaded by

20225455
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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WATTAN

LECTURE CLICHM1
QUALITY CONTROL IN CLINICAL
CONTROL LIMITS (Control Values)
CHEMISTRY -Expected values are represented by intervals of acceptable
QUALITY values with upper and lower limits.
-A degree to which a set of inherent characteristics fulfills
requirements (ISO 9001:2008) -Are calculated from the mean and standard deviation

ISO 9001:2008 -The ideal control/reference limit is between ± 2SD.


-Specifies requirement for a quality management system
where an organization needs to demonstrate its ability that AREAS of QUALITY CONTROL:
meets customer and applicable statutory and regulatory 1. All patients, laboratory personnel, laboratory equipment,
requirement. and laboratory tests are involved.

ISO 15189 2. The laboratory’s relation to other hospital departments


-Helps laboratories establish effective QM’s
3. Laboratory policies and procedures should be collected in a
-Make sure that labs adhere to the guidelines to more accurate manual to be revised at least once a year or when procedures
test results. are changed.

-Quality management in the Medical Laboratories. SYSTEM CONCEPTS of QUALITY CONTROL:


1. Quality Control Surveillance System (QCCS)
-Requirement for quality competence. -Establishes norms that must be met.

QUALITY CONTROL -The main concern is the detection of a problem.


-Part of quality management focused on fulfilling quality
requirements (ISO 9000:2000) 2. Q.C. Corrective System
-Established to offer education of why errors occur; provide a
-Involves the systematic monitoring analytical process in program to remedy defects.
order to detect analytic errors that occur during analysis.
3. Objective Q.C. Parameters
-Systems of assuring the quality of total laboratory -Established to prove that corrective measures have produced
performance. favorable results.

-Ultimately prevent the reporting of incorrect patient test -Examples: Q.C Charts, LJ Charts
results.
LEVEY & JENNINGS
-More applicable by identifying when an error had occurred. -Initially applied the principles of statistically analyzing QC to
the clinical la in 1950.
-External Quality Control
 Interlab TOTAL QUALITY FRAMEWORK
 Proficiency testing -For management of quality in a healthcare system

QUALITY ASSURANCE
Quality Planning
-Part of quality management focused on providing confidence
that the quality requirements will be fulfilled (ISO 9000:2000)
Quality Improvement Quality Lab process
-Objectives:
 To check the stability of machines
 To check the quality of reagents
 To check technical (operations) errors.
Quality Assessment Quality Control
-Involves the monitoring of specimen acquisition, turnaround
time or proficiency testing of materials to determine analytic
performance. Quality Planning
 Set criteria
QUALITY ASSURANCE PROGRAM  Benchmarking
-Set of activities or plan that aims to maintain the highest  Compare business to improve yours
degree of excellence for the diagnosis & treatment of disease  Identify internal opportunities for improvement.
and maintenance of health.
Quality Lab Process
-More applicable to preventing an error from occurring.  Implement corrective actions.

Quality Control
WATTAN
LECTURE CLICHM1
 Identify the error.

Quality Assessment
 Use of quality indicators; allows you to improve when
no error occur.

Quality Improvement
 Allows you to implement and monitor processing
equipment before an error occurs.
 Monitor before error occurs.

PROCEDURES in QUALITY ASSURANCE PROGRAM


A. CONTROL of PRE-ANALYTICAL VARIABLES
FACTORS: *Anything that precedes test performance
1. Patient identification
2. Proper preparation of patient
3. Specimen collection, separation & processing

B. CONTROL OF ANALYTICAL VARIABLES


MAIN FACTORS: *Anything related to test analysis
1. Choice of analytical methodology
2. Calibration procedures
3. Proper documentation of analytical variables
4. Proper labeling & use of reagents
5. Preventive maintenance of analytical instruments
6. Periodic calibration of pipetting devices
7. Periodic checking of °T of refrigerator & heating units
8. Periodic checking of procedure manuals
9. Monitoring of technical competence
10. Inventory of control materials
11. Control assurance that safety measures are operational

C. CONTROL of POST-ANALYTICAL VARIABLES


FACTORS: *Everything that comes after test analysis
1. Verification of calculations of the final results
2. Check test results for possible transcription errors
3. Results should be easy to read & interpret
4. Timeliness of reporting values to patient chart
5. Procedures for informing physicians about results that
require immediate attention

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