Denielle

 Genesis  B.  Camato  

   III.  QUALITY  ASSESSMENT  &  MANAGEMENT  IN  THE  URINALYSIS  LABORATORY  
ANALYSIS  O F  URINALYSIS  AND  BODY  FLUIDS  |  REVIEWER  

QUALITY ASSESSMENT (QA) SPECIMEN COLLECTION AND HANDLING

r refers to the overall process of guaranteeing quality patient ê The actual date and time of specimen collection
care and is regulated throughout the total testing system. ê Whether the specimen was refrigerated before transporting
r program includes: ê The time the specimen was received in laboratory and the
ê testing controls also called Quality Control time it was performed
ê continual monitoring of the entire test ordering ê Test requested
ê specimen collection through reporting ê An area of specific instructions that might affect the
ê interpreting results results of the analysis
ê Essential to this program is having written ê Patient identification information
remedial actions mandating the steps to take r Patient’s sex
when any part of the system fails. r Age
r Date of birth
QA r The source of specimen
r PRE ANALYTICAL FACTORS r Time must be documented.
r ANALYTICAL FACTORS
r POST ANALYTICAL FACTORS
PATIENT PREPARATION
INCLUDED IN QA PROGRAME ARE: ê Fasting or elimination of interfering medications
ê procedure manuals ê Type of volume of specimen required
ê internal quality control ê Sterile or opaque container must be included in the specific
ê external quality control procedure
ê standardization ê urine specimens should be examined within 2 hours
ê proficiency testing (PT) ê If this is not possible:
ê record keeping r written instructions for the preservation of the
ê Equipment maintenance specimen
ê Safety programs
ê Training
ê Education EXAMPLES OF PRE-ANALYTICAL ERRORS
ê Competency assessment of personnel ê Specimen obtained from wrong patient
ê Documented and review process ê Specimen procured at the wrong time
ê Specimen collected in the wrong tube or container
URINALYSIS PROCEDURE MANUAL ê Incorrect labeling of specimen
ê A procedure manual containing all the procedures performed ê Improper processing of specimen
in the urinalysis section
ê must be available for reference in the working area
ê must comply with the CLSI guidelines POLICY FOR HANDLING OF MISLABELED SPECIMEN
ê Whenever changes are made, the procedure should be ê Do NOT assume any information about the specimen or
reviewed and signed by a person with designated authority patient.
ê Do NOT relabel an incorrectly labeled specimen.
LABORATORY PROCEDURE MANUAL ê Do NOT discard the specimen until investigation is complete.
ê Title of the assay ê Leave specimen EXACTLY as you receive it; put in the
ê Principle of the procedure and statement of clinical refrigerator for preservation until errors can be resolved.
applications ê Notify floor, nursing station, doctor’s office, etc. of problem
ê Protocol of specimen collection and storage and why it must be corrected for analysis to continue.
ê QC information ê Identify problem on specimen requisition with date, time, and
ê Reagents, supplies and equipment your initials.
ê Procedural protocol ê Make person responsible for specimen collection participate
in solution of problem(s). Any action taken should be
ê “Normal” reference ranges
documented on the requisition slip.
ê Technical sources of error
ê Report all mislabeled specimens to the quality assurance
ê Limitations of the procedure
board.
ê Proper procedures for specimen collection and storage

ANALYTICAL ERRORS
PRE-ANALYTICAL FACTORS
ê Are the processes that directly affect the testing of
ê test requests
specimens.
ê patient preparation
r Reagent and test performance
ê specimen collection
r instrument calibration and maintenance
ê handling
r QC
ê storage
r personnel requirements
r Good communication of departments and correct r technical competence
procedures,
r improves the Turn Around Time (TAT) of results ,
r avoids duplication of tests and ensures high
quality specimen.

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 Denielle  Genesis  B.  Camato  
   III.  QUALITY  ASSESSMENT  &  MANAGEMENT  IN  THE  URINALYSIS  LABORATORY  
ANALYSIS  O F  URINALYSIS  AND  BODY  FLUIDS  |  REVIEWER  

REAGENTS QUALITY CONTROL

ê Manual should state the name and chemical formula of each ê Quality control refers to the materials, procedures, and
reagent used, instructions for preparation, company source techniques that monitor the accuracy, precision, and
of prepared materials storage requirements and reliability of a laboratory test.
procedures for reagent QC. ê QC are performed to ensure that acceptable standards are
ê A bold type statement of any safety or health precautions met during the process of patient testing.
associated with reagents should be present. E.g. the heat ê Must be done at the beginning of each shift
produced in Clinitest reaction
ê All reagent and reagent strips must be properly labeled with ê Is a process that monitors the accuracy and reproducibility
the date preparation or opening, purchase and received date, of results through the use of control specimens.
expiration date, and appropriate safety information.
ê Reagent strips should be checked against known negative and ACCURACY
positive control solutions on each shift or at a minimum once ê Refers to how closely the measurement approaches the
a day, and whenever a new bottle is opened. true value of the substance being analyzed.
ê Reagents are checked daily or when tests requiring their use ê Synonymous with CORRECTNESS
are requested.
ê Results of all reagent checks are properly recorded. CALIBRATION
ê Is the comparison of an instrument measure or reading to
INSTRUMENTATION AND EQUIPMENT a known physical constant.
ê Most frequently encountered instruments in urinalysis
laboratory: CONTROL
ê Refractometers ê Represents a specimen with a known value that is similar in
ê Osmometers composition.
ê Automated reagent strip readers
ê Automated microscopy instruments PRECISION
ê Synonymous with REPRODUCIBILITY and measures the
CALIBRATION OF INSTRUMENT inherent variability of the test.
ê REFRACTOMETERS are calibrated on each shifts against
distilled water (1.000) STANDARDS
ê Known control } 5% saline (1.022 ±0.001) ê Are highly purified substance of a known composition.
9% sucrose (1.034 ±0.001)
ê Commercial control
r Osmometer
r Urine reagent strip test
r hCG kit tests SPECIFICITY VS SENSITIVITY

CALIBRATION OF INSTRUMENT SPECIFICITY SENSITITIVITY

ê Automated urinalysis systems and reagent strip readers are * Test is defined as the proportion * Defines as the proportion of
calibrated using manufacturer-supplied calibration materials of cases with absence of specific cases with specific disease or
following the protocol specified by he manufacturer. disease or condition that gives condition that gives positive
ê Both positive and negative control values must be run and negative result. result.
recorded * represents what is being measured * increase sensitivity – amount
[ Failed QC test must be documented--- no * it don’t measure interfering or similar of assayed substance is
patient’s testing may be performed until QC is substances. Measured.
acceptable.

TEST PROCEDURE
ê Detailed and concise testing instructions are written in a
step-by-step manner.
ê It should begin with:
þ specimen preparation 6 WESTGARD RULES FOR ANALYSIS OF QUALITY CONTROL
þ the time and speed of centrifugation CHARTS
þ materials and types of glassware needed ê 1 point is outside 2 SD
þ time limitations ê If 1 point is outside 2 SD, then reject when:
þ the stability of specimens and reagents þ 1 point is outside 3 SD (13s)
þ calculation formula þ 2 consecutive points are outside 2 SD on the
þ a sample calculation, health and safety precautions. same side of the center line (22s)
þ Range of 2 points greater than 4 SD ( R4s)
þ 4 consecutive points exceed 1 SD on the same
side of the center lin (41s)
þ 10 consecutive points are above or below the
mean (10x)

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 Denielle  Genesis  B.  Camato  
   III.  QUALITY  ASSESSMENT  &  MANAGEMENT  IN  THE  URINALYSIS  LABORATORY  
ANALYSIS  O F  URINALYSIS  AND  BODY  FLUIDS  |  REVIEWER  

EXTERNAL QUALITY CONTROL MONITORING SUMMARY OF QUALITY ASSURANCE ERRORS

ê External quality controls are used to verify the accuracy
and precision of a test and are exposed to the same PREANALYTICAL
conditions as the patient samples.
ê Reliability is the ability to maintain both precision and Patient misidentification
accuracy. Wrong test ordered
ê Control mean is the average of all data points Incorrect urine specimen
ê Standard deviation (SD) is a measurement statistic that Type collected
describes the average distance each data point in a normal Insufficient urine volume
distribution is from the mean. Delayed transport of urine to the laboratory
ê Coefficient of variation (CV) is the SD expressed as a Incorrect storage or preservation of urine
percentage of the mean. CV indicates whether the
distribution of values about the mean is in a narrow versus
broad range and should be less than 5%. Confidence intervals ANALYTICAL
are the limits between which the specified proportion or
percentage of results will lie.
Sample misidentification
Erroneous instrument calibration
TREND
Reagent deterioration
ê Changes in accuracy of results are indicated.
Poor testing technique
Instrument malfunction
Shift Interfering substances present
ê That is an abrupt change in the mean Misinterpretation of quality
ê Changes in precision are shown by a large amount of scatter
about the mean and an uneven distribution above and below
the mean that are most often caused by errors in POSTANALYTICAL
technique.
Patient misidentification
Poor handwriting
INTERNAL CONTROL MONITORING Transcription error
ê Consist of internal monitoring system built in to the test Poor quality of instrument printer
system and may be called electronic, internal, or procedural Failure to send report
controls.
Failure to call critical values
ê Internal or procedural controls monitor the correct addition
Inability to identify interfering substances
of a patient specimen or reagent, the instruments/reagents
interaction, and test completion.

PROFIECIENCY TESTING
ê It is the testing if unknown samples received from an
outside agency.
ê It provides unbiased validation of the quality of patient test
results.

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