C - Lesson 9 Quality Assurance

Question 1

[?] of patient samples can be a complex procedure, depending on clinical analysis, microbiological stud y, or blood banking testing among other facets of the clinical laboratory.

Answer 1

Laboratory testing

Question 2

is one of the most important impacts on laboratory testing — it ensures both precision and accuracy of patient sample results.

Answer 2

Quality control (QC)

Question 3

The integrity of [?] is important to both management of overall quality as well as to meeting requirements of proficiency testing.

Answer 3

quality control samples

Question 4

Addressing QC issues is critical to the identification of potential errors with patient results, including [?] as well as [?] of testing function.

Answer 4

reagent matrix effects
calibration misalignment

Question 5

Maintaining [?] of laboratory sample testing through quality control is vital to ensuring that patient testing is done right and that it produces accurate results.

Answer 5

accurate and frequent checks

Question 6

A program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided

Answer 6

Quality Assurance Program

Question 7

The overall process of guaranteeing quality patient care

Answer 7

Quality Assurance Program

Question 8

– focus on the monitoring of outcomes or indicators of care

Answer 8

Quality Assurance

Question 9

– applied to activities directed toward the monitoring of the individual elements of care

Answer 9

Quality Control

Question 10

Intralaboratory

Answer 10

Internal Quality Control

Question 11

appropriate and standard laboratory methods, reagents, supplies and equipment

Answer 11

Internal Quality Control

Question 12

proper maintenance and monitoring of all equipment.

Answer 12

Internal Quality Control

Question 13

quality control reference materials.

Answer 13

Internal Quality Control

Question 14

documented, continuous competency assessment program for all laboratory personnel

Answer 14

Internal Quality Control

Question 15

Interlaboratory

Answer 15

External Quality Control

Question 16

intended to monitor the delivery of the overall services of the laboratory as part of the health care team (indicators of quality performance)

Answer 16

External Quality Control

Question 17

National Reference Laboratories

Answer 17

External Assurance Program (Proficiency testing)

Question 18

Recognized reference laboratories.

Answer 18

External Assurance Program (Proficiency testing)

Question 19

Everything that precedes actual test performance

Answer 19

Preanalytical

Question 20

Test ordering by physician

Answer 20

Preanalytical

Question 21

test ordering by nursing/clerical staff

Answer 21

Preanalytical

Question 22

patient preparation

Answer 22

Preanalytical

Question 23

patient identification

Answer 23

Preanalytical

Question 24

specimen collection

Answer 24

Preanalytical

Question 25

specimen transport

Answer 25

Preanalytical

Question 26

specimen processing

Answer 26

Preanalytical

Question 27

Everything related to the actual testing process

Answer 27

Analytical

Question 28

Test analysis

Answer 28

Analytical

Question 29

quality control reagents

Answer 29

Analytical

Question 30

calibration

Answer 30

Analytical

Question 31

preventive maintenance

Answer 31

Analytical

Question 32

Everything that comes after test analysis

Question 33

Verification of calculations and reference ranges

Question 34

review of results

Question 35

procedures for notification of critical values

Question 36

result reporting

Question 37

test interpretation by physician

Question 38

follow patient care

Question 39

All [?] are involved.

Answer 39

patients, laboratory personnel, laboratory equipment, and laboratory tests

Question 40

Specific aspects include

Answer 40

patient preparation and identification, specimen collection, transportation and handling of the specimen, performance of the test, and the reporting of test results

Question 41

The laboratory’s relation to other hospital departments - [?].

Answer 41

the nursing service, the admitting office, the outpatient department, public relations, purchasing, the storeroom, the pharmacy, surgical supplies, and the medical staff

Question 42

should be collected in a manual to be revised at least once a year or when procedures are changed.

Answer 42

Laboratory policies and procedures

Question 43

Copies of this manual should be available to other hospital departments

Answer 43

Laboratory policies and procedures

Question 44

the main concern of this Q.C. system is the detection of a problem

Answer 44

Quality Surveillance System

Question 45

offer education, realization of why errors happen, and program to remedy offer education, realization of why errors defects (equipment, technique, specimen procurement, storage of reagents, etc.)

Answer 45

Quality Control Corrective System

Question 46

established to prove that corrective measures have actually brought results (Q.C. charts, S.D. calculations, etc.)

Answer 46

Objective Q.C. Parameters

Question 47

Provide resources for independent assessment of the technical performance

Answer 47

External programs

Question 48

Methods that are intended to monitor the delivery of the overall services of the laboratory as part of the health care team (indicators of quality performance)

Answer 48

Quality Monitoring & Assessment tools

Question 49

eg. Validity of diagnosis & suitability of services provided

Answer 49

Quality Monitoring & Assessment tools

Question 50

The Total Testing Process

Answer 50

requesting for the test specimen collection actual analysis reporting of results interpreting the result

Question 51

Patient

Answer 51

Specimen Collection

Question 52

Time of collection

Answer 52

Specimen Collection

Question 53

Method of collection

Answer 53

Specimen Collection

Question 54

Collection equipment

Answer 54

Specimen Collection

Question 55

Technical & Physical facilities

Answer 55

Specimen Collection

Question 56

Processing

Answer 56

Specimen Preparation

Question 57

Centrifugation

Answer 57

Specimen Preparation

Question 58

Separation

Answer 58

Specimen Preparation

Question 59

Method/Procedure

Answer 59

Actual Analysis

Question 60

Reagents

Answer 60

Actual Analysis

Question 61

Standards and Controls

Answer 61

Actual Analysis

Question 62

Glasswares/Equipment/Machines

Answer 62

Actual Analysis

Question 63

Technical & Physical facilities

Answer 63

Actual Analysis

Question 64

Method/Manner of Reporting

Answer 64

Reporting & Interpretation

Question 65

Laboratory language (Communication) o Laboratory interpretation o Physician’s interpretation

Answer 65

Reporting & Interpretation

Question 66

Professional Relationships within and outside the Laboratory

Answer 66

Reporting & Interpretation

Question 67

o “There shall be a system of accurate recording to ensure quality results”

Answer 67

RA 4688

Question 68

o “There shall be a provision for filing, storage and accession of all reports.

Answer 68

RA 4688

Question 69

Laboratory records

Answer 69

Recording

Question 70

Anatomic & Forensic records

Answer 70

Recording

Question 71

Written policies and procedures

Answer 71

Quality Assurance Plan

Question 72

Routine evaluation of staff performance

Answer 72

Quality Assurance Plan

Question 73

Continuing education (documented)

Answer 73

Quality Assurance Plan

Question 74

Safety program

Answer 74

Quality Assurance Plan

Question 75

Specimen collection and handling

Answer 75

Quality Assurance Plan

Question 76

Safety program (for staff and patients)

Answer 76

Quality Assurance Plan

Question 77

Corrective action required if controls are out of range

Answer 77

Quality Assurance Plan

Question 78

(to ensure that scheduled activities & duties are performed

Answer 78

Checklist

Question 79

(specimens from PT sponsors should be treated exactly like the patients sample

Answer 79

Participation in proficiency testing

Question 80

– gives official approval that the laboratory follows all of the guidelines set forth by the accrediting agency.

Answer 80

Accreditation by the appropriate agency

Question 81

Factors affecting Quality Assurance Program (QAP)

Answer 81

✓ Staffing ✓ Physical facilities ✓ Equipment/Instruments ✓ Glasswares/Reagent/Supplies ✓ Waste Management/Biohazard practices ✓ Quality Control Programs ✓ Reporting ✓ Recording ✓ Patient ✓ Bench Space ✓ Methods/Procedures/tests ✓ Standards ✓ Controls ✓ Laboratory rules and regulations ✓ Professional Relationships within and outside the Laboratory

Question 82

10 steps to a Quality Assurance Plan

Answer 82

1. Assign responsibility 2. Delineate scope of care 3. Identify important aspects of care 4. Identify indicators related to these aspects of care 5. Establish thresholds for evaluation 6. Gather and organize data 7. Evaluate care when thresholds are reached 8. Take corrective action 9. Asses the effectiveness of actions; document improvement 10. Communicate relevant information

Question 83

is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory.

Answer 83

Laboratory quality control

Question 84

can be defined as accuracy, reliability and timeliness of reported test results.

Answer 84

Laboratory quality

Question 85

The [?] must be as accurate as possible, all aspects of the [?] must be reliable, and [?] must be timely in order to be useful in a clinical or public health setting.

Answer 85

laboratory results laboratory operations reporting

Question 86

In order to achieve the highest level of accuracy and reliability, it is essential to perform [?] in the laboratory in the best possible way.

Answer 86

all processes and procedures

Question 87

The [?] is a complex system, involving many steps of activity and many people.

Answer 87

laboratory

Question 88

The [?] of the system requires that many processes and procedures be performed properly.

Answer 88

complexity

Question 89

Therefore, the [?], which looks at the entire system, is very important for achieving good laboratory performance

Answer 89

quality management system model