FACTORS THAT AFFECT QUALITY ASSURANCE PROGRAM

A Laboratory is a complex system; all aspects must function properly to

achieve quality. Clinical Laboratories play a vital role in the healthcare
delivery system. The implementation of well-documented laboratory
standards helps laboratories to demonstrate a well-functioning quality
management system, technical competence, and customer-focused
services that contribute to quality health care services.

The capacity of clinical laboratories to adequately perform tests and

produce accurate and reliable results depends on many factors that are
interdependently and collectively influence the quality systems.

The total quality Assurance Cycle

However, some factors will affect the quality assurance program. These
may include the following:
● Individual responsibilities unclear/ lack of job description
● No written procedures
● Written procedures not followed
● Checks not done for transcription errors
● QC, EQA not performed
● Delay of result reporting time
● Poor internal quality control practice
The pre-analytical phase- is the most vulnerable part of the testing
process, where the majority of the laboratory occurs.
● Specimen mislabeled or unlabeled
● Specimen stored inappropriately before testing
● Specimen transported inappropriately
● Test kits stored inappropriately
The analytical phase- is a complex process involving the control of
many factors to ensure the integrity of the laboratory results.
● The country algorithm not followed
● Incorrect timing of test
● Results reported when control results are invalid
● Improper measurements of specimens or reagents
● Reagents stored inappropriately or used after the expiration date
● Dilution and pipetting errors
● Incorrect reagents used
Post-analytical phase- is the final phase of laboratory work in which
laboratory results are evaluated until they are released.
● Transcription error in reporting
● Report illegible
● Report sent to the wrong location
● Information system not maintained
● absence of a result verification system
The significant factors affecting the provision of quality laboratory
services were the following:
A. Lack of management support- continuous support and
commitment to overall organisational and management
controls In the overall operations of the laboratory. A passionate
interest in quality and obtaining the best possible outcomes.
Expect all laboratory activities to utilize the QMS and comply with
QMS requirements. Necessary resources for the delivery of care
should be provided. Consistently engages and encourages
effective communication.
B. Shortage of resources- resulting in inadequate suitable
infrastructure, poorly trained personnel, shortage of
reagents/supplies, and lack of standardisation.
C. Poor equipment management system- lack of standards for
proper preventive maintenance, calibration, and verification of
laboratory equipment.
D. High workload- impaired the quality of services. The number
of services should be equated with the standard number of
staff, as a high workload also results in high equipment
failure.
E. Lack of competent staff- Building knowledge to fully
understand quality aspects and develop skills to use quality
tools and approaches in their daily process. Training
programs should be continuously implemented to promote
skills and increase expertise. This program ensures good
staff performance.
 1. Low staff motivation system- Implementing a staff motivation
program is an excellent incentive for the staff as professional
growth allows and generates attitudes of commitment to the
successful implementation of QMS.
2. Ineffective communication system- poor communication can
result in various adverse outcomes and many laboratory
mistakes in the total testing process—the interactions among
personnel and exchange of information between employees,
managers, and the organization's multiple levels have proper
feedback that minimizes the sense of ambiguity among
employees and ensures a common understanding of the plan
and achieving common goals.
3. Lack of proper documentation - a system that incorporates all
management and technical activities that affect the services
and quality of the results.
Lack of a well-established quality management system- standard
parameters must be more adequately established and disseminated to
all laboratory staff.
i.

References:

http://www.atdforum.org/IMG/pdf/
Clinical_Laboratory_Diagnostics_in_Africa.pdf