Fundamentals of Quality Management

Case Study 1

You have become the manager of a community hospital laboratory shortly after the
previous manager was terminated because of deficiencies in the laboratory accreditation
and assessments and no document plan for quality. Upon review of previous accreditation
assessment reports, you discover several instances of deficiencies repeated from cycle to
cycle despite the laboratory’s documented responses of “corrective actions”. Your review
of the administrative manual reveals no logical organization and a lot of missing
information, that if present, would have alleviated many deficiencies. You’ve been asked
to ensure significant improvement on the laboratory’s next accreditation assessment 18
months away.

Issues and questions:

1. What is the laboratory’s path of workflow?

The laboratory’s path of workflow is a cyclical process that is divided into three phases:
pre-analytic, analytic, and post-analytic. Each phase contributes to the development of
quality and efficient laboratory practices that starts from the pre-analytic phase which
includes test ordering from the physician, then comes the analytic phase that begins when
the patient specimen is collected and is prepared for testing, and eventually transported.
Lastly, the post-analytic phase is the final phase of the overall testing process that is
comprised of processing testing, results review, interpretation of result - which is the
critical part, and the discarding of samples wherein proper disposal must be observed.
Basing on the situation presented, there has been negligence in the laboratory workflow
which leads to several deficiencies.

2. What are the levels of laboratory quality?

The levels of laboratory quality emanates from quality control, in which its goal is to
target accurate results by means of fulfilling quality requirements. Directly after the
quality control is the quality assurance that establishes the expected working process and
is in compliance with the target quality. The levels of laboratory quality concludes with
quality management system that is responsible in ensuring the laboratory workflow
progresses smoothly.

3. What is the link between laboratory quality management and patient safety?

The correlation between laboratory quality management and patient safety is that
laboratory quality management stipulates a firm foundation of outstanding and quality
healthcare to the patient and its major goal to prevent negative outcomes which is the
cornerstone of a quality health-care, especially in the laboratory.
4. How can a laboratory administrative manual be organized to promote quality
management?

Having a laboratory administrative manual promotes quality management in a way that it

serves as a framework for meeting quality requirements. Furthermore, the laboratory
administrative manual is essential because it is a means of achieving, maintaining, and
improving accuracy as well as reliability for quality management.