CLS 361 UNIT 1 URINALYSIS, RENAL FUNCTION, AND DISEASE STUDY GUIDE

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what are the three basic principles of laboratory safety?

• ID of hazards

• precautions to adhere to

• applying “common sense”

state the purpose of the standard precautions policy and describe its guidelines (learning objective; ch.1)

was integrated into laboratory safety protocols to manage hazards and to establish clinical precautions that must be followed at all times to prevent the transmission of infections and protect personnel from exposure to bloodborne pathogens

applies to hand hygiene, gloves, mouth, nose, and eye protection, gown, patient-care equipment, environmental control, linen, occupational health and bloodborne pathogens, patient placement, respiratory hygiene/cough etiquette

what is postexposure prophylaxis (PEP)?

report accident immediately to supervisor and prompt testing of the source patient and the employee for HIV, HBV, and HCV

follow CDC updated guidelines for the management of exposures and recommended PEP

what is the primary method of infection transmission and what should be done?

hand contact is the primary method and to avoid this, hands should be sanitized in the following conditions:

• before patient contact

• after gloves are removed

• before leaving the work area

• at any time when hands have been knowingly contaminated

• before going to designated break areas

• before and after using bathroom facilities

includes hand washing and using alcohol-based antiseptic cleansers

describe the acceptable methods for handling and disposing of biological waste and sharp objects in the urinalysis laboratory (learning objective; ch.1)

• specimens and contact material go into biohazard-labeled containers and are disposed of according to lab protocol… empty contains go into nonbiohazardous waste

  • urine can be poured down the sink (no splashes) and flush sink with water

  • sink is maintained with a daily 1:5 or 1:10 sodium hydrochlorite flush which can also be used on countertops

• sharp objects like needles, lancets, and broken glassware are put into puncture-resistant, leak proof containers that are conveniently located in work area

what is decontamination needed for?

• contaminated nondisposable equipment

• blood spills

• areas that process blood and body fluids

do not wipe or mop a spill → use absorbent powder or paper towels and disinfect the area with bleach or phenol solution

explain the role of quality management (QM) in the urinalysis laboratory (learning objective; ch.1)

is the overall process of guaranteeing quality patient care and is achieved when the laboratory implements a quality system (laboratory’s policies, processes, procedures, and resources needed to achieve quality testing)

• the QM system consists of testing controls (QC) and three variables: preexamination, examination, and postexamination

• a well-documented QA program will use guidelines from accredited agencies like CAP and CLSI, which establishes procedure manuals, internal (embedded in the actual test) and external quality control (has lvl 1 and 2 then the actual test), standardization and equipment maintenance, proficiency testing (looks for consistency between labs) and record-keeping, safety programs, training, education, competency assessment

what is included in a urinalysis procedure manual?

• principle or purpose of the test

• clinical significance

• patient preparation

• specimen type and method of collection

• specimen acceptability and criteria for rejection

• reagents, standards, and controls

• instrument calibration and maintenance protocols and schedules

• step-by-step procedure, calculations

• frequency and tolerance limits for controls and corrective actions

• REFERENCE VALUES AND CRITICAL VALUES

• interpretation of results

• specific procedure notes

• limitations of the method

• method validation

• confirmatory testing

• recording of results

• references

• effective date, author, and review schedule

how are laboratory procedures and new methodologies evaluated and updated?

an ongoing process where current methods are reviewed annually → procedure manual changes should be reviewed, referenced, and signed by a person with designated authority & all personnel are notified of changes

what are preexamination variables? (learning objective; ch.1)

variables that occur before testing (test requests, patient preparation and timing, specimen collection, specimen handling, transport, and storage) → requires communication and adequate training among health-care personnel outside the clinical lab

• patient prep, collection instructions, criteria to reject a specimen, and documentation of problems and corrective actions are included in the procedure manual for preexamination variables

what is turnaround time (TAT)?

the amount of time required from when a test is ordered by the time health-care provider until the results are reported to the health-care provider and is for STAT and routine tests

is improved using cause and effect

what is included in requisition and computerized entry forms? (learning objective; ch.1)

• patient identification information

  • name, sex, age, date of birth, hospital ID number (MRN)

• test requested

• type of urine specimen to be obtained (voided, clean catch, catheterized)

• requested date and time of collection

• actual collection information (time, storage/transport condition)

• received and tested time

what would determine a specimen acceptable? (learning objective; ch.1)

• matching patient information on specimen and requisition form

• properly labeled specimen

• timely transport or refrigeration

• adequate amount of specimen

• noncontaminated specimen

• tightly closed container

must have documented rejection procedures

what are examination variables? (learning objective; ch.1)

processes that directly affect the testing of specimens, which involves reagents, instrumentation and equipment, test procedure, QC, preventive maintenance, access to procedure manuals, and competency of personnel performing the tests

what information and procedures should be included for laboratory reagents?

• manufacturer, name, and chemical formula

• instructions for preparation

• type of water used in preparation

  • Clinical Laboratory Reagent Water (CLRW)

• storage requirements

• procedures for reagent quality control

• label with date of opening or preparation

• check reagent strips daily or each shift and when a new bottle is opened and record results

• safety and health precautions

what should be clearly stated in the instructions for instrumentation and equipment?

• operation, calibration, limitations, dilution procedures, recording

• calibration and control of refractometers, osmometers, reagent strip readers

• temperatures of refrigerators and water baths (recorded daily)

• calibration and disinfection of centrifuges

• prepare a routine preventive maintenance schedule

• document all routine and nonroutine maintenance

what information should be included in a laboratory testing procedure?

• specimen preparation: time and speed of centrifugation

• specimen and reagent stability

• calculation formulas

• health and safety precautions

• sources of error and interference

• clinical situations influencing test, alternate procedures

• helpful hints

• turnaround time for STATs

what is quality control (QC)? (learning objective; ch.1)

a part of quality management and are the materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test… it must always be performed if reagents are changed, the instrument has malfunctioned, or the test results are questioned by the provider → test results cannot be reported until the QC is verified

QC procedures ensure that acceptable standards are met during the process of patient testing and is performed at scheduled times (ex. beginning of the shift)

what is external quality control (QC)? (learning objective; ch.1)

Verifies the accuracy and precision of a test and is exposed to the same conditions as a patient sample…with external QC, two levels of control should be run, and the concentration of the controls should be at medically significant levels and as similar to human specimens as possible (must be free of HIV, Hep C, and Hep B)

documentation of QC must include date of opening, manufacturer’s lot number, and expiration date each time a control is run… same person running the controls must run the patient samples too

describe how reference ranges are created (learning objective; ch.1)

the mean (average) of the samples (control and/or patient) are taken and the standard deviation, more specifically ± 2SD or ±3 SD from the mean, is calculated

what is internal quality control (QC)? (learning objective; ch.1)

internal monitoring systems that are built into the test system and monitors the sufficient addition of a patient sample or reagent, instruments/reagents interaction, and test completion

what is electronic quality control (QC)? (learning objective; ch.1)

uses a mechanical or electrical device in place of a liquid QC specimen which is inserted into a POC instrument to verify the functional ability of a testing device

what is proficiency testing (external quality assessment)? (learning objective; ch.1)

unbiased validation of the quality of patient test results that is done through testing unknown samples provided by an external agency → the accuracy is evaluated and compared to other laboratories using the same method of analysis and the vendor will statistically rate answers from all participating labs and return the report to lab director (corrective actions are performed and documented)

vendors supply materials to laboratory then the laboratory tests materials and returns results to vendor

what is an individualized quality control plan?

an alternative option that provides quality testing to meet CLIA regulations and considers the entire testing process → requires risk assessment, a QC control plan, and quality assessment

involves selecting quality monitors which include QC and PT records, patient results, specimen rejection logs, TAT reports, preventive measures, corrective action, and follow-up records, and personnel competency records

what are the key requirements for laboratory personnel and facilities?

• education and training, continuing education, competency assessment, and performance appraisals

• training and continuing education must be documented

• checklist of procedures

• current reference materials must be available

• safe working area with adequate space & standard precautions followed at all times

what are postexamination variables? (learning objective; ch.1)

processes that affect the reporting of results and correct interpretation of data → uses standardized reporting formats (electronic transmission most common) in order to minimize health-care provider confusion with reference ranges included

written procedures should be available for the reporting of critical values

what should be done when releasing results after testing? (learning objective; ch.1)

• when using the phone to release results, confirm that the results are being reported to the appropriate person (read back)

• correct erroneous results in a timely manner but do not delete the original result from the chart… also document

what should be included when interpreting laboratory test results?

test sensitivity and specificity and list all interfering substances

a well-documented QA program ensures quality test results and patient care

what is accuracy?

correctly reflects the “true value” of the result

what is precision?

same result is achieved every time it is repeated

what is variance (s²)?

indicator of the precision of a group of numbers… indicates how close together, or how precise, the numbers within a group are

• large variance = wide range of values

• small variance = numbers are closer in value (more precise)

the square root of variance is standard deviation (most frequently used measure of precision)