(3) Lesson 9: Quality Management Flashcards by 3sha Ann

Q

Defined as accuracy, reliability, and timeliness of reported test results

A

Laboratory quality

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Q

Negative consequences of laboratory error (5)

A

Unnecessary treatment
Treatment complications
Failure to provide the proper treatment
Delay in correct diagnosis
Additional and unnecessary diagnostic testing

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Q

The negative consequences result in increased cost in ___ and ___ ___ and often in poor ___ ___

A

time
personnel effort
patient outcomes

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Q

Identify the term and fill in the blanks:

Coordinated activities to direct and control an organization with regard to quality (___ and ___ definition)

A

Quality Management System

ISO
CLSI

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Q

A method of detecting errors at each phase of testing is needed if quality to be assured

A

Quality Management System

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Q

Factors that must be addressed to assure quality in the laboratory (6)

A

the laboratory environment
quality control procedures
communications
record keeping
competent and knowledgeable staff
good-quality reagents and equipments

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Q

A set of procedures for continuously assessing laboratory work and the emergent results (WHO)

A

Internal Quality Control (IQC)

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Q

Internal quality control may also refer to ___ ___

A

Quality control

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Q

Quality control:

Examining “___” materials of known substances along with patient samples to monitor the accuracy and precision of the complete analytic process

A

control

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Q

Quality control:

Monitors activities related to ___ (___) phase of testing

A

examination
analytic

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Q

Quality control:

Goal: to detect, evaluate, and correct ___ due to test system failure, environmental conditions or operator performance, before patient results are reported

A

errors

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Q

Quality control: (type of examination)

Measure the quantity of an analyte present in the sample

A

Quantitative examinations

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Q

Quality control: (type of examination)

Measurements need to be accurate and precise

A

Quantitative examinations

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Q

Quality control: (type of examination)

Measurement produces a numeric value as an end-point, expressed in a particular unit of measurement

A

Quantitative examinations

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Q

Quality control: (type of examination)

Blood glucose = 5 mg/dL

A

Quantitative examinations

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Q

Quality control: (type of examination)

Measure the presence or absence of a substance or evaluate cellular characteristics such as morphology

A

Qualitative examinations

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Q

Quality control: (type of examination)

Results are expressed in qualitative terms

A

Qualitative examinations

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Q

Quality control: (type of examination)

Microscopic examinations

A

Qualitative examinations

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Q

Quality control: (type of examination)

Positive/Negative
Normal/Abnormal

A

Qualitative examinations

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Q

Quality control: (type of examination)

Serologic procedures for presence or absence of antigens and antibodies

A

Qualitative examinations

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Q

Quality control: (type of examination)

Reactive/nonreactive

A

Qualitative examinations

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Q

Quality control: (type of examination)

Microbiological procedures

A

Qualitative examinations

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Q

Quality control: (type of examination)

Growth/no growth

A

Qualitative examinations

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Q

Quality control: (type of examination)

Results are expressed as an estimate of how much of the measured substance is present

A

Semiquantitative examinations

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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)

1. Purchased 2. Obtained from a central or reference laboratory 3. 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)