(3) Lesson 9: Quality Management Flashcards
Defined as accuracy, reliability, and timeliness of reported test results
Laboratory quality
Negative consequences of laboratory error (5)
Unnecessary treatment
Treatment complications
Failure to provide the proper treatment
Delay in correct diagnosis
Additional and unnecessary diagnostic testing
The negative consequences result in increased cost in ___ and ___ ___ and often in poor ___ ___
time
personnel effort
patient outcomes
Identify the term and fill in the blanks:
Coordinated activities to direct and control an organization with regard to quality (___ and ___ definition)
Quality Management System
ISO
CLSI
A method of detecting errors at each phase of testing is needed if quality to be assured
Quality Management System
Factors that must be addressed to assure quality in the laboratory (6)
the laboratory environment
quality control procedures
communications
record keeping
competent and knowledgeable staff
good-quality reagents and equipments
A set of procedures for continuously assessing laboratory work and the emergent results (WHO)
Internal Quality Control (IQC)
Internal quality control may also refer to ___ ___
Quality control
Quality control:
Examining “___” materials of known substances along with patient samples to monitor the accuracy and precision of the complete analytic process
control
Quality control:
Monitors activities related to ___ (___) phase of testing
examination
analytic
Quality control:
Goal: to detect, evaluate, and correct ___ due to test system failure, environmental conditions or operator performance, before patient results are reported
errors
Quality control: (type of examination)
Measure the quantity of an analyte present in the sample
Quantitative examinations
Quality control: (type of examination)
Measurements need to be accurate and precise
Quantitative examinations
Quality control: (type of examination)
Measurement produces a numeric value as an end-point, expressed in a particular unit of measurement
Quantitative examinations
Quality control: (type of examination)
Blood glucose = 5 mg/dL
Quantitative examinations
Quality control: (type of examination)
Measure the presence or absence of a substance or evaluate cellular characteristics such as morphology
Qualitative examinations
Quality control: (type of examination)
Results are expressed in qualitative terms
Qualitative examinations
Quality control: (type of examination)
Microscopic examinations
Qualitative examinations
Quality control: (type of examination)
Positive/Negative
Normal/Abnormal
Qualitative examinations
Quality control: (type of examination)
Serologic procedures for presence or absence of antigens and antibodies
Qualitative examinations
Quality control: (type of examination)
Reactive/nonreactive
Qualitative examinations
Quality control: (type of examination)
Microbiological procedures
Qualitative examinations
Quality control: (type of examination)
Growth/no growth
Qualitative examinations
Quality control: (type of examination)
Results are expressed as an estimate of how much of the measured substance is present
Semiquantitative examinations
Quality control: (type of examination)
Expressed in terms such as “trace amount”, “moderate amount”, or “1+2+, or 3+”
Semiquantitative examinations
Quality control: (type of examination)
Urine dipstick, tablet tests for ketones
Semiquantitative examinations
Quality control: (type of examination)
Serologic agglutination procedure
Semiquantitative examinations
Quality control: (type of examination)
Serologic testing result expressed as a titer
Semiquantitative examinations
Elements of a quality control program:
Establishing written ___ and ___, including corrective action
policies
procedures
Elements of a quality control program:
___ all laboratory staff
training
Elements of a quality control program:
Ensuring complete ___
documentation
Elements of a quality control program:
Reviewing ___ control data
quality
In implementing a quality control program, the ___-___ charts are used to develop graphs to plot control values
Levey-Jennings
Laboratory practices in assuring quality
Preventive
Assessment
Corrective
Laboratory practices in assuring quality:
activities done prior to the examination of specimen or sample and are intended to establish systems conducive to accuracy in analytic systems such as preventive maintenance and calibration of instruments, testing of media, orientation and training of personnel
Preventive
Laboratory practices in assuring quality:
activities done during the testing to determine whether the test systems are performing correctly such as the use of standards and control materials and maintenance of control charts
Assessment
Laboratory practices in assuring quality:
activities done when error or possible error is detected to correct the system such as equipment trouble shooting, recalibration of instruments, etc.
Corrective
substances that contain an established amount of the substance being tested
Control materials
Substance being tested
Analyst
tested at the same time and in the same way as patient samples
Control materials
Its purpose include:
to validate the reliability of the test system
Control materials
Its purpose include:
to evaluate the operator’s performance and environmental conditions that might impact results
Control materials
also called standards
Calibrators
solutions with a specified defined concentration that are used to set an instrument, kit, or system before testing is begun
Calibrators
T/F: calibrators should be used as controls
F (should not be used as controls since they are used to set the instrument)
T/F: Calibrators usually do not have the same consistency as patients’ samples
T
Types of control materials
Frozen
Freeze-dried
Chemically preserved
T/F: Freeze-dried/lyophilized materials must be reconstituted, requiring great care in pipetting in order to ensure the correct concentration of the analyte
T
Sources of control materials (3)
- Purchased
- Obtained from a central or reference laboratory
- Made in-house by pooling sera from different px.
have a predetermined target value, established by the manufacturer
Assayed control
laboratory must verify the value using its own methods
Assayed controls
T/F: Unassayed controls are more expensive to purchase than assayed controls
F (Assayed controls are more expensive)
T/F: In establishing the value range for the control material, determine the range of acceptable values for the control material to know if the test run is “in control” or “out of control”
T
This is done by assaying the control material repeatedly over time
Establishing the value range for the control material
In establishing the value range for the control material, at least __ data points must be collected over a __-__ day period
20
20-30
This process includes calculating the mean and standard deviation of the results
Establishing the value range for the control material
T/F: the purpose of obtaining 20 data points by running the QC sample is to quantify normal variation and establish ranges for QC samples
T
one or two data points that appear to be too high or low for the set of dat
Outliers
presence among the __ data points indicate a problem with the data
20
T/F: When the presence among the 20 data points indicate a problem with the data, it should still be included when calculating QC ranges
F
T/F: when the presence among the 20 data points indicate a problem with the data, one should identify and resolve the problem and repeat the data collection
T
commonly used to represent the control range graphically for the purpose of daily monitorin
Levey-Jennings chart
shows the mean value as well as +/- 1, 2, and 3 SD
Levey-Jennings chart
In levey-jennings chart, this is shown by drawing a line horizontally in the middle of the graph
mean
In levey-jennings chart, this is marked off at appropriate intervals and lines drawn horizontally on the graph
SD
In interpreting quality control data, If the value is within +2 SD, the run can be accepted as “___”
in- control
One should employ ___ ___ for a more comprehensive decision making
Westgard Rules
occur when an abrupt change is followed by six or more consecutive QC results that fall on one side of the mean, but typically within 95% range as if clustered around a new mean
Shifts
In shifts, results are ___
rejected
occur when values gradually, but continually, move in one direction over six or more analytical runs
Trends
may display values across the mean, or they may occur only on one side of the mean
Trends
In trends, results are ___
rejected
Factor of selection of test:
The ___ produced should be useful in a time reference frame
result
Factor of selection of test:
The ___ should be feasible for the particular laboratory
procedure
Factor of selection of test:
The ___ produced should be accepted to clinicians
value
Factor of selection of test:
The ___ forwarded to clinicians should be uniform
reports
A good report should be ___ and ___ in terminology and format.
compact
consistent
maybe defined as the extent to which measurements are repeated
Precision
assessment is made by replicate analysis of a biological control containing stable and measurable amounts of the appropriate constituents(s) and expressed as the magnitude of error in the method
Precision
maybe defined as the extent to which measurement approach the “true” quantity of the constituent being analyzed
Accuracy
measurement must be conducted on a reference material having a known composition and concentration.
Accuracy
the extent to which the minimum amount of constituent can be measured of
Sensitivity
the reliability of a test to be positive in the presence of the disease it was designed to detect
Sensitivity
the extent to which measurements are those of single constituent
Specificity
the reliability of a test to be negative in the absence of a disease it was designed to detect
Specificity
program where participating laboratories are given
unknown samples for analysis
External Quality Assessment Program (EQAP)
samples are to be treated as ordinary human specimens for the usual processing and examination
External Quality Assessment Program (EQAP
certificate of participation is required for renewal of the laboratory’s
External Quality Assessment Program (EQAP
administered by the different National Reference Laboratories (NRL)
External Quality Assessment Program (EQAP
EQAP is stipulated in DOH AO __-__
2007-0027
NRL for Clinical Chemistry
Lung Center of the PH
NRL for Hematology
National Kidney and Transplant Institute
NRL for HIV/AIDS and other sexually transmitted infections
San Lazaro Hospital STD AIDS Cooperative central laboratory
NRL for Parasitology, Bacteriology, and Mycobacteriology
Research Institute for Tropical Medicine
NRL for Environmental, Occupational Health, Toxicology and Micronutrient Assay
East Avenue Medical Center
NRL for -Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus 1&2, Syphilis and Malaria among blood banks and blood service facilities
Transfusion Transmissible Infections-NRL
the same as the National External Quality Assessment Scheme (NEQAS) in the Philippines, however, the term NEQAS is more widely used
Proficiency testing
a program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others (CLSI definition)
Proficiency testing
In proficiency testing, the optimal frequency will be __-__ times yearly
3-4
widely used in countries that strictly follow CLIA regulations
Proficiency testing
may be administered by third party providers
Proficiency testing
slides that have been read are rechecked by a reference laboratory
Rechecking or retesting
samples that have been analyzed are retested, allowing for interlaboratory comparison
Rechecking or retesting
external evaluation of quality on-site and can be conducted in conjunction with PT or rechecking/retesting
On-site evaluation
usually done when it is difficult to conduct traditional proficiency testing or to use the rechecking/retesting method
On-site evaluation
a predefined written procedural method in the design and implementation of laboratory procedures
Laboratory protocol
provides individual sets of instructions that allow scientists to recreate laboratory procedures that include requisitioning, reporting, assays, statistical methods, reporting and troubleshooting standards
Laboratory protocol
most commonly used for recording test results and other informative data not usually reported
Worksheets
are particularly well suited to most hospital Microbiology, Chemistry and Hematology laboratories
Worksheets
the customary practice is to attach identification band to all patients
Patient identification
the exact matching of all patient information appearing on the request with that on the bracelet should be done
Patient identification
In patient identification, ask for at least __ unique identifiers before doing specimen collection such as in phlebotomy
two
usually done for special tests and in cases of equipment downtime
Specimen reassignments (Send-out/ Outsourcing)
