ANALYSIS OF URINE AND BODY FLUIDS — LECTURE

Quality Assessment
3rd Year 2nd Semester — FEU Medical Technology

QUALITY ASSESSMENT
URINALYSIS PROCEDURE MANUAL
● Quality Management (QM) - overall process of
REQUIRED INFORMATION FOR EACH PROCEDURE
guaranteeing quality patient care, and it is regulated
● Principal or purpose of the test
throughout the total testing system
● Clinical significance
● Quality Management System (QMS) - all of the
● Patient preparation
laboratory’s policies, processes, procedures, and
● Specimen type and method of collection
resources needed to achieve quality testing
● Specimen acceptability and criteria for rejection
● Documentation of QM procedures is required by all
● Reagents
laboratory accreditation agencies (International
● Standards and controls
Organization for Standardization)
● Instrument calibration and maintenance protocols and
schedules
QUALITY ASSESSMENT PROGRAM
● Step-by-step procedure
● Procedure manuals ● Calculations
● Internal quality control ● Frequency and tolerance limits for controls and
● External quality control corrective actions
● Electronic quality control ● Reference values and critical values
● Calibration or calibration verification ● Interpretation of results
● Standardization ● Specific procedure notes
● Proficiency testing (PT), more formally known as ● Limitations of the method
external quality assessment (EQA) ● Method validation
● Record-keeping ● Confirmatory testing
● Equipment maintenance ● Recording of results
● Safety programs ● References
● Training ● Effective date
● Education and competency assessment of personnel ● Author
● A review process that is scheduled and documented ● Review schedule

TESTING QUALITY CONTROL COMPONENTS OF QUALITY ASSESSMENT

PREEXAMINATION VARIABLES
Preexamination Variables Specimen collection, ● Occur before the actual testing of the specimen
handling, and storage ● Health-care personnel outside the clinical laboratory
control many of these factors
Examination Variables Reagent and test ● Test requests, patient preparation, timing, specimen
performance, instrument collection, handling, and storage
calibration and maintenance,
personnel requirements, and SPECIMEN COLLECTION AND HANDLING
technical competence
● Procedural Manual
Postexamination Variables Reporting of results and ● Accession Forms
interpretation ● Requisition Forms
○ Designate the type of urine specimen to be
collected and the date and time of collection
DOCUMENTATION ● Internal laboratory quality improvement form
● Required by all laboratory accreditation agencies: ● The form should include space for recording:
○ The Joint Commission (TJC) ○ The actual date and time of specimen
○ College of American Pathologists (CAP) collection
○ American Association of Blood Banks ○ Whether the specimen was refrigerated
(AABB) before transporting
○ American Osteopathic Association (AOA) ○ The time the specimen was received in the
○ American Society of Histocompatibility and laboratory and the time the test was
Immunogenetics (ASHI) performed
○ American Association for Laboratory ○ Tests requested
Accreditation (A2LA) ○ An area for specific instructions that might
○ Commission on Laboratory Assessment affect the results of the analysis
(COLA) ○ Patient identification information (sex, age or
● Required for Medicare and Medicaid reimbursement date of birth, source of spx, time of
● Guidelines published by CAP and the CLSI provide collection)
very complete instructions for documentation and are
used as a reference for the ensuing discussion of the
specific areas of urinalysis QC and QM

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 ● Specifications and limitations
SPECIMEN PREPARATION AND HANDLING ● Procedures to follow when limitations or linearity are
exceeded, such as dilution procedures
Preparation of Specimen
● Fasting or elimination of interfering medications
● Type and volume of spx required Positive Control 9% Sucrose
● Need for sterile or opaque containers
● All urine spx should be examined within 2 hours Negative Control 5% Saline
● Manners of preservation
Normal Control Deionized Water
Collection
● Collecting clean-catch and midstream specimens
● Specimen processing Urine Analysis Instruments
● Printed instructions that are given to patients ● Refractometers
○ Calibrated daily or when used against
Criteria for Specimen Rejection deionized water (1.000) and a known control
● Labeling errors ● Osmometers
○ Two levels of commercial controls are
Criteria for Urine Specimen Rejection available
● Unlabeled containers ● Automated reagent strip readers
● Nonmatching labels and requisition forms ○ Calibrated using manufacturer-supplied
● Specimens contaminated with feces or toilet paper calibration materials, following the protocol
● Containers with contaminated exteriors specified by the manufacturer
● Insufficient volume of urine ● Automated microscopy instruments
● Specimens that were transported or preserved
improperly Maintenance
● Delay between time of collection and receipt in the ● Deionized water used for reagent preparation is
laboratory quality controlled by checking pH and purity meter
resistance on a weekly basis and the bacterial count
EXAMINATION VARIABLES on a monthly schedule

● Processes that directly affect the testing of specimens

● Reagents, instrumentation and equipment, testing Temperature of refrigerators Daily
procedure, QC, preventive maintenance (PM), access and water baths
to procedure manuals, and competency of personnel
performing the tests Calibration of centrifuges and Every 3 months
accuracy of timers
REAGENTS
Disinfection of centrifuges Weekly basis or after
● All reagents and reagent strips must be properly spills
labeled with the date of preparation or opening,
purchase and received date, expiration date, and
Microscopes Annual professional
appropriate safety information
cleaning and daily
● Reagents are checked daily or when tests requiring
cleaning
their use are requested

REQUIRED INFORMATION FOR REAGENTS Automatic pipettes Initially and periodically

● Name and chemical formula checked for accuracy
● Instructions for preparation and reproducibility
● Manufacturer, manufacturer lot number
● Manufactured date and expiry date TESTING PROCEDURE
● Storage requirements
● Procedures for reagent QC ● Detailed, concise testing instructions are written in a
● Type of water for preparing reagents step-by-step manner
● Safety or health precautions
REQUIRED INFORMATION
REQUIREMENTS FOR REAGENT STRIPS ● Specimen preparation
● Checked against known negative and positive control ● Reasons for special precautions
solutions on each shift or, at a minimum, once a day ● Sources of error and interfering substances
and whenever a new bottle is opened ● Criteria for the correlation of the physical, chemical,
● Never refrigerated and microscopic urinalysis results
● Protected from light ● Helpful hints
● Recapped immediately after removing each strip ● Clinical situations that influence the test
● Alternative procedures
INSTRUMENTATION AND EQUIPMENT ● TATs for stat tests
● Reference sources
REQUIREMENTS FOR PROCEDURE MANUAL
● Instructions regarding the operation performance
● Frequency of calibration

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 ● Specimen collection date and time
QUALITY CONTROL ● Specimen source (if pertinent to the test)
● Condition of unsatisfactory specimen
● Quality Control - materials, procedures, and
● Tests performed, the results, and the reference
techniques that monitor accuracy, precision, and
ranges of the tests
reliability of laboratory test
● Date and time of the final results generated
● The step-by-step instructions for each test should
● Facility where the test was performed
include specific QC info regarding the type of control
specimen preparation and handling, frequency of use,
WRITTEN REPORTS
tolerance levels, and methods of recording
● Performed at scheduled times, such as the beginning ● Standardized reporting format and reference ranges
of each shift or before patient testing samples and it ● A written procedure for reporting, reviewing, and
must always be performed if reagents are changed correcting errors
● Forms for reporting results should provide adequate
● External QC - used to verify the accuracy and space for writing and should present the information
precision of a test and are exposed to the same in a logical sequence
conditions as the patient samples
○ Commercial controls are available for urine ELECTRONIC RESULTS
chemistry tests, specific gravity, and for
● Electronic transmission - most common method for
certain microscopic constituents
reporting results
○ Analysis of two levels of materials is required
● Many urinalysis instruments have the capability for
● Internal QC - internal monitoring systems built into
the operator to transmit results directly from the
the test system and are called internal or procedural
instrument to the designated health-care provider
controls; monitors the sufficient addition of a patient
specimen or reagent, the instruments/reagents
TELEPHONE (VERBAL) RESULTS
interaction
● Electronic Controls - use a mechanical or electrical ● The telephone is frequently used to transmit results of
device in place of a liquid QC specimen STAT tests and critical values
● Proficiency Testing (EQA) - testing if unknown ● When telephoning results, confirm that:
samples received from an outside agency and ○ Results are being reported to the appropriate
provides unbiased validation of the quality of px test person
results ○ Time of call
○ Name of person receiving the results must
INDIVIDUALIZED QUALITY CONTROL PLAN be documented according to the facility’s
policy
● Alternative CLIA QC option that provides equivalent
○ Must be repeated by the person receiving
quality testing to meet the CLIA regulations for
the information and documented by the
moderate- and high- complexity tests and
person giving the report
provider-performed microscopy procedures tests
● Considers the entire testing process and to ensure
RESULT ERRORS
quality testing and not just the frequency of QC and
number of QC materials ● Discovered via Delta check
○ Compares a patient’s test results with the
IQCP QA involves selecting quality monitors that include: previous results
● QC records ● Auto-verification is often programmed into many
● PT records laboratory analyzers
● Review of patient results ● Patient’s record should be corrected as soon as the
● Specimen rejection logs error is detected; however, the original result must not
● TAT reports be erased if the healthcare provider treated the
● Records of preventive measures, corrective actions, patient based on the erroneous results
and follow-up ● Appropriate documentation of erroneous results
● Personnel competency records should follow institutional protocols

PERSONNEL AND FACILITIES CRITICAL RESULTS

● Personnel assessment includes education and ● Critical values - test results that are significantly
training, continuing education, competency lower or higher than the normal reference range
assessment, and performance appraisals ● There should be written procedures available for the
● Each new employee must have documentation of reporting of critical values
training during orientation to the laboratory
INTERPRETING RESULTS
POSTEXAMINATION VARIABLES
● The specificity and the sensitivity for each test should
● Processes that affect the reporting of results and be included in the procedure manual for correct
correct interpretation of data interpretation of results
● Sensitivity - the lowest level of an analyte that a test
REQUIRED INFORMATION IN THE LABORATORY REPORT can detect
● Patient’s first and last name ● Specificity - the likelihood of measuring the analyte
● Patient’s unique identification number desired

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