Introduction to quality Flashcards
_______________ can be def i ned as accuracy, reliability and timeliness of reported test results.
The laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in a clinical or public health setting.
Laboratory quality
When making measurements, there is always some level of inaccuracy. The challenge is to reduce the level of inaccuracy as much as possible, given the limitations of our testing systems. An accuracy level of __% may at fi rst glance appear acceptable, but the resulting _% error can become quite large in a system where many events occur, such as laboratory testing.
99, 1
unnecessary treatment
treatment complications
failure to provide the proper treatment
delay in correct diagnosis
additional and unnecessary diagnostic testing.
Negative consequences of laboratory error
can be defined as “coordinated activities to direct and control an organization with regard to quality”.
This def i nition is used by the International Organization for Standardization (ISO) and by the Clinical and Laboratory Standards Institute (CLSI). Both groups are internationally recognized laboratory standards organizations
In this, all aspects of the laboratory operation, including the organizational structure, processes and procedures, need to be addressed to assure quality.
quality management system
There are many procedures and processes that are performed in the laboratory, and each of these must be carried out correctly in order to assure accuracy and reliability of testing. An error in any part of the cycle can produce a
poor laboratory result.
ISO standards group
laboratory processes (3)
pre-examination, examination and post-examination categories.
The entire set of operations that occur in testing is called the ______________
It begins with the patient and ends in reporting and results interpretation
path of workflow.
the laboratory environment
quality control procedures
communications
record keeping
competent and knowledgeable staff
good-quality reagents and equipment.
factors that must be addressed to assure quality in the laboratory.
The most important laboratory resource is
competent, motivated staff
is comprised of several factors that are important in ensuring the quality of the laboratory testing processes.
These factors include quality control for testing, appropriate management of the sample, including collection and handling, and method verification and validation
Process control
was one of the first quality practices to be used in the laboratory and continues to play a vital role in ensuring accuracy of testing.
quality control
product of the laboratory is
information
is an error or an event that should not have happened. A system is needed to detect these problems or occurrences, to handle them properly, and to learn from mistakes and take action so that they do not happen again.
occurrence
is a tool for examining laboratory performance and comparing it to standards, benchmarks or the performance of other laboratories.
It may be internal (performed within the laboratory using its own staff) or it may be external (conducted by a group or agency outside the laboratory).
Laboratory quality standards are an important part of this, serving as benchmarks for the laboratory.
process of assessment
The primary goal in a quality management system is
continuous improvement of the laboratory processes
