Terminology
The accuracy, reliability, and timeliness of the reported test results. 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
What is Laboratory Quality?
Three key organizations providing internationally recognizable standards for quality
What is the ISO, the CLSI and the WHO?
Three processes a sample will go through
What is pre-examination, examination & post-examination?
TAT
What is turn around time?
Identify, and record deviations, non-conformance, unusual occurrences, and unexpected or adverse outcomes
What is non-conforming event management
Part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000). In the clinical laboratory includes all the actions a laboratory takes to ensure quality results
What is quality assurance?
Six sigmas 5 phases (DMAIC)
What is define, measure, analyze, innovate improvement and control?
The term for the building blocks of the path of workflow
What is quality system essentials?
Laboratories in AB are not all accredited T/F
What is false? they are all accredited by the college of physicians and surgeons
a measure of the severity of the impact of a potential error, multiplied by the probability of how likely it is that the error will occur and the ability to detect the error if it should occur
What is risk?
Part of quality management and is focused on fulfilling quality requirements (ISO 9000). In the clinical laboratory, this process monitors a measurement procedure (examination process)
What is quality controls?
We discussed two methods for continuous quality control (CQI)
What are six sigma and lean?
A statement of intent, describes what is done
What is policy
At least three components of quality system essentials
What are assessments, documents and records, information management, nonconforming event management, continual improvement, info managment, personell, purchasing & inventory, equipment, process management, organization, customer focus, facilities & safety?
A type of external assessment which is a means of verifying the accuracy and reliability of the laboratory’s examination results. It is a comparison of the laboratory’s results to the performance of a peer group of laboratories or the performance of a reference laboratory.
Serves as the standard of excellence or performance level against which process, in this case laboratory service, is measured. If the service does not meet a certain benchmark, then the quality must be improved.
_______ requires ongoing effort towards reducing waste & improving workflow efficiency
What is Lean?
The most vulnerable phase of the workflow process
Pre-examination
What is scheduled checks of stock levels, rotating stock to ensure freshness, ordering supplies in efficient quantities & minimizing cost of carrying inventory?
Activities conducted by sources outside the laboratory, such as those performed by governmental and accreditation organizations, to evaluate the effectiveness of the laboratory’s QMS
What are external quality assessments?
The activity associated with improving the laboratory’s ability to meet and exceed the needs and expectations of the patients. It is part of process management focused on reducing variation and improving process effectiveness and efficiency.
What is quality improvement?
An inventory control system which aligns inventory with actual consumption
What is Kanban?
A pre-examination activity that can lead to variability of specimen
What is collection, transportation, evaluation of specimens, ordering, patient prep, ID, handling etc
The general 3 part rule for the kanban system
What is right to left, top to bottom, front to back?
procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. A laboratory is visited by representatives from an accreditation body who are looking for evidence of compliance with standards, policies, procedures, requirements and regulations and also observe laboratory staff to ensure that they perform functions and duties correctly and competently
What is accrediation?