TOTAL QUALITY MANAGEMENT Flashcards
This pertains to a systems approach that focuses on teams, processes, statistics, and delivery of service or products that meet or exceed the customer expectations
Total Quality Management
What are the ultimate goals of Total Quality Management?
Complying with regulations, standards, and practice guidelines
Customer satisfaction
What is the Laboratory’s main product?
Information
for clinical decision making
Laboratory Quality is defined by the WHO as:
accuracy, reliability, and timeliness of reported test results.
The laboratory test 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
If inaccurate results are released by a clinical laboratory, the following would be the significant consequences EXCEPT
A. Personnel dissatisfaction
B. Inaccurate diagnosis
C. Unnecessary treatment
D. Failure to provide proper treatment
A.
Significant consequences include:
- unnecessary treatment
- treatment complications
- failure to provide the proper treatment
- delay in correct diagnosis
- additional and unnecessary diagnostic testing
Which areas are required to have complex interdigitation of expertise to have good laboratory management
Medical, Technical and Scientific areas
This pertains to the pattern of behavior used to engage others to complete tasks in a timely and productive manner
Leadership
__________ uses human, financial, physical and information resources available to an organization in the most efficient and effective way
Management
This pertains to the coordinated activities to direct and control an organization with regard to quality
Quality Management System
This is a set of coordinated activities that functions as building blocks of quality management
Twelve quality systems essentials
A quality system essential for establishing and implementing quality policy
Organization
What are the key components of organization?
Leadership
Organizational structure
Planning process
Implementation
Monitoring
This is the most important laboratory resource
Personnel
-must be a competent and motivated staff
This quality system essential assures all reagents and supplies are of good quality, integrity and reliability
Purchasing and Inventory
This quality systems essential is important in assuring the quality of laboratory testing process
Process control
includes:
Quality control
Sample management
Method verification and validation
This laboratory document pertains to the overall document for the quality system and provides the framework for its design and implementation
Quality manual
This laboratory document contains step-by-step written instructions for each procedure; ensures consistency in delivery procedures
Standard Operating Procedures (SOPs)
These are the sources of scientific and clinical information about diseases, laboratory methods, and procedures
Reference Materials
This pertains to an error or event that should not have happened
Occurrence
This pertains to the tool for examining laboratory performance and comparing it to standards, benchmarks, or performance of other laboratories
Laboratory assessment
This is the systematic and planned approach to assessing, monitoring and improving the quality of health services on a continuous basis
Quality assurance
This is the overall process used to ensure that laboratory results meet the requirements for health care services to patients
Total Quality Management
Which of the following is not covered by the quality system essential: EQUIPMENT?
a. acquisition and installation
b. validation
c. inventory management
d. records
e. troubleshooting and maintenance system
c. inventory management
is under purchasing and inventory
Of the 12 quality system essentials, which pertains to the laboratory proficiency performance and accreditation?
Laboratory Assessment
includes: Proficiency Testing, Inspection, Accreditation
This pertains to the entire set of operations that occurs in testing for Quality Assurance
Path of Workflow
The entire path of workflow begins with the: __
… and ends in the: __
begins with PATIENT SAMPLE COLLECTION
ends in the REPORTING OF RESULTS INTERPRETATION
This phase of quality assurance involves any factors involving acquiring, handling, transporting, and processing of patients’ specimen prior to actual testing
Pre-analytical phase
True or false:
the pre-analytical phase also includes activities involving patient preparation such as fasting, before the subject reaches the laboratory
True
What are the pre-analytical variables that may affect test results?
Test and sample collection
Physiological
Diet
Lifestyle
Drugs
The following are steps and activities involved in pre-analytical examination of laboratory operations except:
A. Interpretation and encoding of results
B. Patient / Clinical preparation
C. Sample receiving
D. Sample collection
E. Test-ordering
A. Interpretation and encoding of results
is post-analytical phase
This is the most serious specimen handling problem that occurs in the pre-analytical phase of QA
mislabeling of specimen
What is the most critical aspect of specimen collection and transport?
patient identification and specimen labeling
True of False:
Second-hand orders placed by nurses or clerks exhibit lesser error rates
FALSE = higher error rates
This phase of QA involves any factors relating to the test platform and the testing process itself done in the laboratory
Analytical phase
According to WHO, laboratory quality is defined as
A. accuracy, reliability, and timeliness of result
B. competence of personnel
C. public and staff safety
D. proper laboratory waste disposal
A. accuracy, reliability and timeliness of result
This pertains to the cause of a medically significant difference in the measured test result due to another component or property of the sample
Interference
This phase culminates in the production of a final value, result, or in the case of histology, a diagnostic pathology report
Post-analytical phase
This refers to the time interval between the specimens received in the laboratory to the time of reports dispatched with verification
Turnaround time
This is one of the most noticeable signs of laboratory service and a key performance indicator of laboratory performance
Turnaround time
This provides confidence in the reproducibility of test results
Quality control
This vital part of quality assurance functions in evaluating and correcting errors due to the test system failure, environmental conditions or operator performance before patient’s results are reported
Quality control
Recording and monitoring test variables such as temperature, reagents, controls and equipment function allowing one to look objectively and retrospectively at parameters vital to the accuracy and precision of tests is which part of QA?
Quality Control
Quality control depends upon the following except:
A. Specimen storage
B. Time between the test performed
C. Calibration of the instrument
D. Integrity of system
E. Training of technicians
D. Integrity of system
Quality Assurance or Quality Control?
This is the part of quality management focused on fulfilling quality requirements
Quality control
Quality Assurance or Quality Control?
This is an overall management plan to guarantee the integrity of data
Quality Assurance
Quality Assurance or Quality Control?
This is the part of quality management focused on providing confidence that quality requirements will be fulfilled
Quality Assurance
Quality Assurance or Quality Control?
This is a series of analytical measurements used to assess the quality of the analytical data
Quality Control
Quality Assurance or Quality Control?
This simply ensures that the results generated by the test are correct
Quality control
Quality Assurance or Quality Control?
This ensures that the right test is carried out on the right specimen, and that the right result and interpretation are delivered to the right person at the right time
Quality Assurance
Which of the following defines Sensitivity?
A. Percentage of patients without the disease that receive a negative result
B. Percentage of patients with the disease that receive a positive result
C. The probability that subjects with a positive screening test truly have the disease
D. The probability that subjects with a negative screening test truly
B. Sensitivity pertains to the percentage of patients with the disease that receive a positive result
What is the formula for Specificity?
TN/(TN+FP)
TN/Not Diseased
This pertains to the percentage chance that the test will correctly identify the person who is disease free
Specificity
Which of the following pertains to the Positive Predictive Value?
A. Percentage of patients without the disease that receive a negative result
B. Percentage of patients with the disease that receive a positive result
C. The probability that subjects with a positive screening test truly have the disease
D. The probability that subjects with a negative screening test truly
C.
What is the formula for the Negative Predictive Value?
TN/(TN+FN)
This pertains to the percentage chance that the test will correctly identify a person who actually has the disease.
Sensitivity
What is the formula for sensitivity?
TP/(TP+FN)
or
TP/Diseased
Which of the following pertains to NPV?
A. Percentage of patients without the disease that receive a negative result
B. Percentage of patients with the disease that receive a positive result
C. The probability that subjects with a positive screening test truly have the disease
D. The probability that subjects with a negative screening test truly don’t have the disease
D.
What is the formula for the positive predictive value?
TP/(TP+FP)
This pertains to how close or similar are 2 or more measurements to each other
Precision
If in the lab you obtain a 3.2 kg weight for a given substance, but the actual or known weight is 10 kg, then your measurement is not __________
Accurate
This pertains to the tool that form basis for introducing a system of QA
Quality indicators
This ensures the consistency of the product, services, and results
Quality management
What are the four main components of quality management?
Quality planning, control, assurance, improvement
Instead of specific tasks, Human Resources focuses on:
roles
Since this pertains to criteria-based job description, it clearly identifies responsibilities, accountability, and internal and external organizational relationships. This is known as:
Human Resources
This pertains to infective agents that must be taken into consideration for laboratory safety
Biological hazards
This pertains to the collective group of injuries involving the body systems in response to long term and repetitive twisting, bending, lifting, or assuming static postures for an extended period of time
Economic Hazards
This refers to a series of analytical masurements used to asses the quality of analytical data:
A. Quality assurance
B. Quality control
C. Sensitivity
D. Accuracy
B. Quality control
This pertains to the actual measurement performed in the sample:
A. Analytical phase
B. Post-analytical phase
C. Controlling
D. Process improvement
A. Analytical phase
The laboratory supervisor noticed a discrepancy in the test results done by two laboratory technologists on the sam blood sample. He suspected that an error on technical procedure could be the main coase. What laboratory document would he suggest to refer to:
A. quality manual
B. standard operating manual
C. engineering manual
D. biosafety manual
D. standard operating manual
DOCUMETS:
QM = provides framework for its design and implementation
SOP = for step-by-step written instruction for each procedure; ensures consistency in delivery of procedures
Referene materials = sources of scientific and clinical infos about diseases, lab methods, and procedures
Which of the following is not considered a possible source of pre-analytical error?
A. secondhand orders placed by nurses and medical clerks
B. handling and storage of samples
C. reproducibility of test results
D. incorrect patient identification and labeling
C. reproducibility of results
-analytical phase
Part of quality management that is focused on providing confidence that quality requirements will be fulfilled
A. Quality assurance
B. Quality control
C. Information management
D. Process control
A. Quality assurance
Choose all that applies:
The following are significant consequences if inaccurate results are released by the laboratory:
A. unncessary treatment
B. delay in the correct diagnosis
C. increase revenue for the laboratory
D. increase healthcare confidence
A and B.
