Experiment 2: Concepts of Quality Control and Safety in Serologic Testing

Question 1

Refers to the overall process of guaranteeing quality patient care and is regulated throughout the total testing system

Answer 1

QUALITY ASSESSMENT or QUALITY ASSURANCE (QA)

Question 2

are the variables that occur before the actual testing of the specimen

Answer 2

Pre-analytical factors

Question 3

Pre-analytical factors

Answer 3

• Test request
• Patient preparation
• Specimen collection, handling, and storage

Question 4

are the processes that directly affect the testing of specimens.

Answer 4

Analytical factors

Question 5

Analytical factors

Answer 5

• Reagents • Instrumentation and equipment: instrument calibration and maintenance • Testing procedure • Preventive maintenance • Access to procedure manuals • Competency of personnel performing the tests

Question 6

o Refers to the materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test

Answer 6

Quality Control (QC)

Question 7

are performed to ensure that acceptable standards are met during the process of patient testing

Answer 7

o QC procedures

Question 8

• Used to verify the accuracy and precision of a test and are exposed to the same conditions as the patient samples.

is the ability to maintain both precision and accuracy

Answer 8

External quality controls

Reliability

Question 9

(ability to obtain the expected result)

Answer 9

accuracy

Question 10

(ability to obtain the same result on the same specimen)

Answer 10

precision

Question 11

consists of internal monitoring systems built into the test system

Answer 11

Internal quality control

Question 12

controls monitor the correct addition of a patient specimen or reagent, the instruments/reagents interaction, and test completion

Answer 12

• Internal or procedural

Question 13

monitor a test system’s electronic or electric components

Answer 13

• Electronic controls

Question 14

• The testing of unknown samples received from an outside agency

Answer 14

Proficiency testing

Question 15

• It provides unbiased validation of the quality of patient test results

Answer 15

Proficiency testing

Question 16

are processes that affect the reporting of results and correct interpretation of data.

Answer 16

Post-analytical factors

Question 17

How close measurement is to true value

Answer 17

o Accuracy

Question 18

How close results are when same sample is tested multiple times

Answer 18

o Precision

Question 19

Range of values over which laboratory can verify accuracy of test system

Answer 19

o Reportable range

Question 20

Formerly called normal value

Answer 20

o Reference interval

Question 21

Lowest concentration of substance that can be detected by test method

Answer 21

o Analytical sensitivity

Question 22

Ability of method to measure only analyte it is supposed to measure and not other related substances

Answer 22

o Analytical specificity

Question 23

• Process of testing and adjusting analyzer’s readout to establish correlation between measured and actual concentrations

Answer 23

o Calibration

Question 24

• Reference material with known concentration of analyte

Answer 24

o Calibrator

Question 25

• Testing materials of known concentrations (calibrators, controls, proficiency testing samples, patient specimens with known values) to ensure accuracy of results throughout reportable range

Answer 25

o Calibration verification

Question 26

• Test three (3) levels: high, midpoint, and low

Answer 26

o Calibration verification

Question 27

• Required every 6 months, when lot number of reagents changes, following preventive maintenance or repair, and when controls are out of range

Answer 27

o Calibration verification

Question 28

Positive results in a patient who has the disease

Answer 28

True Positive (TP)

Question 29

Positive results in a patient who does not have the disease

Answer 29

False Positive (FP)

Question 30

Negative results in a patient who does not have the disease

Answer 30

True Negative (TN)

Question 31

Negative results in a patient who has the disease

Answer 31

False Negative (FN)

Question 32

% of population with the disease that test positive

Answer 32

Diagnostic sensitivity

Question 33

% of population without the disease that test negative

Answer 33

Diagnostic specificity

Question 34

% of time that a pos itive result is corr ect

Answer 34

Positive predictive value (PPV)

Question 35

% of time that a negative result is correct

Answer 35

Negative predictive value (NPV)

Question 36

Study to verify accuracy of new method

Answer 36

o Correlation study

Question 37

Schedule of maintenance to keep equipment in peak operating condition

Answer 37

o Preventive maintenance

Question 38

Procedures specified by manufacturer to evaluate critical operating characteristics of test system

Answer 38

o Function checks

Question 39

Comparison of patient data with previous results

Answer 39

o Delta checks

Question 40

Other Components of QA Program

Answer 40

o Correlation study o Preventive maintenance o Function checks o Delta checks

Question 41

Study to verify accuracy of new method

Answer 41

o Correlation study

Question 42

Schedule of maintenance to keep equipment in peak operating condition

Answer 42

o Preventive maintenance

Question 43

Procedures specified by manufacturer to evaluate critical operating characteristics of test system

Answer 43

o Function checks

Question 44

Comparison of patient data with previous results

Answer 44

o Delta checks

Question 45

Types of Safety Hazard

Answer 45

Biological Sharp Chemical Radioactive Electrical Fire/explosive Physical

Question 46

Infectious agents

Answer 46

Biological

Question 47

Bacterial, fungal, viral or parasitic infections

Answer 47

Biological

Question 48

Needles, lancets, and broken glass

Answer 48

Sharp

Question 49

Cuts, punctures, or blood-borne pathogen exposure

Answer 49

Sharp

Question 50

Preservatives and reagents

Answer 50

Chemical

Question 51

Exposure to toxic carcinogenic or caustic agents

Answer 51

Chemical

Question 52

Equipment and radioisotopes

Answer 52

Radioactive

Question 53

Radiation exposure

Answer 53

Radioactive

Question 54

Ungrounded or wet equipment and frayed cords

Answer 54

Electrical

Question 55

Burns or shock

Answer 55

Electrical

Question 56

Bunsen burners and organic chemicals

Answer 56

Fire/explosive

Question 57

Burns or dismemberment

Answer 57

Fire/explosive

Question 58

Wet floors, heavy boxes and patients

Answer 58

Physical

Question 59

Falls, sprains and strains

Answer 59

Physical

Question 60

o Denotes infectious materials or agents that present a potential health risk

Answer 60

BIOHAZARD/Biological Health Hazard

Question 61

o Chain of infection and safety practices related to the

Answer 61

biohazard symbol

Question 62

o Concern over exposure to blood-borne pathogens resulted in the drafting of guidelines and regulations by the (?) and the (?) to prevent exposure

Answer 62

Centers for Disease Control and Prevention (CDC) Occupational Safety and Health Administration (OSHA)

Question 63

The (?) guidelines describe four levels of biosafety depending upon the biological agents isolated or studied.

Answer 63

National Institutes of Health

Question 64

The (?) are based on the virulence of the agents and the availability of effective treatments and vaccines

Answer 64

four levels of biosafety

Question 65

laboratories handle agents that have no known potential for infecting healthy people.

Answer 65

1. Biosafety Level 1 laboratories

Question 66

are those laboratories that work with microorganisms associated with human diseases that are rarely serious and for which preventive or therapeutic interventions are often available.

Answer 66

2. Biosafety Level 2 laboratories

Question 67

is recommended for materials that may contain viruses not normally encountered in a clinical laboratory and for the cultivation of mycobacteria. Working with mycobacteria requires the use of N95 HEPA filter respirators.

Answer 67

3. Biosafety Level 3

Question 68

is required for work with dangerous and exotic agents that pose a high risk of aerosol-transmitted laboratory infections and life-threatening diseases for which effective treatments are limited.

Answer 68

4. Biosafety Level 4

Question 69

Exposure risks

Answer 69

• Accidental punctures with needles • Spraying (aerosols) or spilling infectious materials onto desktop or floor • Cuts or scratches from contaminated objects • Centrifuge accidents: aerosols, broken tubes, etc.

Question 70

all patients are considered to be possible carriers of blood-borne pathogens

Answer 70

o Universal Precautions (UP)

Question 71

These guidelines are not limited to blood-borne pathogens; they consider all body fluids and moist body substances to be potentially infectious

Answer 71

Body Substance Isolation (BSI)

Question 72

• Guideline describing personnel protective practices

Answer 72

Standard Precaution

Question 73

o The guideline recommends wearing gloves when collecting or handling blood and body fluids contaminated with blood and wearing face shields when there is danger of blood splashing on mucous membranes and when disposing of all needles and sharp objects in puncture-resistant containers

Answer 73

Universal Precautions (UP)

Question 74

o The CDC excluded urine and body fluids not visibly contaminated by blood, although many specimens can contain a considerable amount of blood before it becomes visible

Answer 74

Universal Precautions (UP)

Question 75

personnel should wear gloves at all times when encountering moist body substances.

Answer 75

Body Substance Isolation (BSI)

Question 76

o A major disadvantage is that they do not recommend handwashing following removal of gloves unless visual contamination is present

Answer 76

Body Substance Isolation (BSI)

Question 77

o Present a serious biological hazard, particularly for the transmission of blood-borne pathogens

Answer 77

SHARP HAZARDS

Question 78

Specimens that are POTENTIALLY infectious

Answer 78

o Blood o Pus and purulent fluids o Semen o Vaginal secretions o Cerebrospinal fluid o Pleural fluid o Peritoneal fluid o Pericardial fluid o Amniotic fluid o Breast milk

Question 79

Specimens that are usually NOT infectious (unless visibly bloody)

Answer 79

o Feces o Nasal secretions o Sputum o Sweat o Tears o Urine o Vomitus

Question 80

is a law monitored and enforced by OSHA.

Answer 80

Occupational Exposure to Blood-Borne Pathogens Standard

Question 81

Specific requirements of this OSHA standard include the following: 1. Requiring all employees to practice (?) 2. Providing laboratory coats, gowns, face and respiratory protection, and (?) gloves to employees and for nondisposable protective clothing 3. Providing (?) and prohibiting recapping of needles 4. Prohibiting eating, drinking, smoking, and (?), lip balm, and contact lens in the work area 5. Labeling all (?) material and containers 6. Providing free immunization for (?) 7. Establishing a (?) for work surfaces; an appropriate disinfectant for blood-borne pathogens is 8. Providing (?) for employees who have been accidentally exposed to blood-borne pathogens 9. Documenting (?) in safety standards for employees

Answer 81

UP/Standard Precautions laundry facilities sharps disposal containers applying cosmetics biohazardous HBV daily disinfection protocol medical follow-up regular training

Question 82

§ Any accidental exposure to a possible blood-borne pathogen must be

Answer 82

immediately reported

Question 83

§ Evaluation of the incident must begin right away to ensure appropriate

Answer 83

post-exposure prophylaxis (PEP)