Basic Knowledge CH 1 and CH 3

Question 1

established quality standards for all laboratory testing to ensure accuracy, reliability, and timeless of pt test results, regardless of where the test was performed.

Answer 1

CLIA 88 Clinical Laboratory improvement amendement of 1988

Question 2

Types of Certificate under CLIA 88

Answer 2

• Waiver
• PPM (Provider Performed Microscopy)
• Registration
• Compliance
• Accreditation

Question 3

-Cleared by FDA for home use
- Simple methodologies that pose no risk of harm to patient if preformed incorrectly
EX: Pregnancy Test, Glucose monitoring Hgb-Copper Sulfate

Answer 3

Waived testing

Question 4

Automated clinical laboratory equipment
ex: microscopic analysis of urine sediment, culture inoculations, gram stains

Answer 4

Moderate Complexity Testing (Non-waived)

Question 5

Require clinicals Laboratory expertise beyond normal automation to perform
ex: peripheral smears, flow cytometry, gel electrophoresis, and most molecular diagnostic tests

Answer 5

High Complexity Testing (Non-waived)

Question 6

Can conduct unannounced or announced inspections of any accredited or CLIA exempt lab at any time during normal operating hours

Answer 6

Department of Health and Human Services (HHS)

Question 7

Primary Accrediting Organizations

Answer 7

• (COLA) Commission on Office Laboratory Accreditation
• (CAP) College of American Pathologist
• (TJC) The Joint Commission
  MAINTAIN COMPLIANCE

Question 8

Requires that training in handling chemical hazards, as well as training in handling infectious materials(standard precautions), be included for all new test personnel.

Answer 8

OSHA ( The US Occupational Safety and Health Administration)

Question 9

A private alternative to help laboratories stay in compliance with the new CLIA regulations

Answer 9

COLA (Commission on Office Laboratory Accreditation)

Question 10

A federal agency with responsibilities that include the Medicare and Medicaid programs; Regulation of all non-research laboratory testing performed on humans in the US.

Answer 10

CMS (Centers for Medicare and Medicaid)

Question 11

A global driver of quality improvement and pt safety in healthcare

Answer 11

TJC (The Joint Commission)

Question 12

Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care

Answer 12

CAP (college of pathologies)

Question 13

Test performed at the bedside of the patient or near the site where the patient is; a decentralized form of laboratory testing-the laboratory goes to the patient.

Answer 13

POCT (Point of care testing)

Question 14

The pt is aware of, understands, and agrees to the nature of the testing to be done and what will be done with the results reported.

Answer 14

Informed Consent

Question 15

Any results obtained for specimens from patients must be kept strictly confidential. Any information including the types of measurements being done, must also be kept in confidence.

Answer 15

HIPPA (Health Insurance Portability and Accountability Act

Question 16

Results of laboratory testing are to be used in a court of law, a specific chain documentation is required, whereby all steps of the testing are recorded, from specimen collection to the issuing of the results reported.

Answer 16

Chain of Custody

Question 17

The discipline deals with good or bad or a set of moral principles.

Answer 17

Ethics

Question 18

Identifies the specialties, subspecialties, and specific analytes or tests that require testing participation. Required by CMS under CLIA regulations fro non-waived tests.

Answer 18

Proficiency Testing

Question 19

A phase of testing that is highly susceptible to human error
- Test selection
- Patient ID
-Collection of the sample
-Handling of the sample
-Pipetting
- Centrifugation

Answer 19

Pre-analytical testing

Question 20

All parts of testing related to equipment functions, quality control, sample mix-ups in the lab, and any interferences with the true results

Answer 20

Analytical Testing

Question 21

The final phase of the total testing process.
Test records must contain relible ID of patient specimens, traceability of specimen, and who performed the test
Test reports include the result and interpretation that is forwarded to the requesting clinician

Answer 21

Post analytical testing

Question 22

Director, technical consultant, clinical consultant, and testing personnel

Answer 22

Moderate complexity

Question 23

Direct and Testing personnel

Answer 23

PPM

Question 24

Director, Technical supervisor, Clinical consultant, general supervisor, and testing personnel.

Answer 24

High complexity

Question 25

Lab performing only waived test

Answer 25

Waiver

Question 26

Lab where a physician, supervised midlevel practitioner, or a dentist performs specific microscopy procedures during a patient's visit (moderate complexity tests)

Answer 26

PPM

Question 27

Allows a lab to perform non-waived testing until inspection for compliance can be completed

Answer 27

Registration

Question 28

Given to a lab once deemed compliant with CLIA regulation after inspection; given to labs performing moderate and/or high complexity testing

Answer 28

Compliance

Question 29

issued to a lab that has successfully been accredited by an accreditation organization approved by CMS

Answer 29

Accreditation

Question 30

Provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals.

Answer 30

American society for clinical pathology (ASCP)

Question 31

Established for the desire for greater autonomy and control over the direction of the profession by nonphysician laboratory professionals.

Answer 31

American Society for Clinical Laboratory Science (ASCLS)

Question 32

What is the value of quality in the clinical laboratory?

Answer 32

It is the elimination of errors such as - Ordering an inappropriate test - Not ordering an appropriate - Reporting an incorrect inaccurate test results - Not interpreting an appropriate test result properly

Question 33

Only by using the various_________systems can the________ of results be ensured. No matter how carefully a lab assay has been carried out, valid lab results can be reported only when preanalytical ______ has been ascertained.

Answer 33

Quality assessment, reliability, quality control

Question 34

The ability of a laboratory assay to produce consistent results when testing is repeated successively

Answer 34

Reliability

Question 35

Set of laboratory procedures designed to ensure that a test method is working properly and that the results meet the diagnostic needs of the physician. Improves the accuracy and reliability of testing and reduces the need for retesting and unnecessary procedures and treatments.

Answer 35

Quality Control

Question 36

What category if tested is required to abide by certain QA standards as imposed by CLIA 88 and administrated by CMS

Answer 36

Non waived

Question 37

Occurs at the interface between a healthcare worker and the patient. - Missing blood vessels during phlebotomy - Error with data entry - Failing to identify a pt before phlebotomy

Answer 37

Active Errors

Question 38

Related to the organization or design of a laboratory. -Staffing problems - Equipment malfunction -Teamwork Factors

Answer 38

Latent Error

Question 39

Proficiency testing is required by _______ for (waived/nonwaived) test only.

Answer 39

CLIA , nonwaived

Question 40

Name 4 alternate assessment methods for proficiency testing.

Answer 40

External split sample, Internal split sample, Audit sample, and use government and university interlaboratory comparison.

Question 41

Participate with another laboratory using the same method or another method

Answer 41

External Split Sample

Question 42

Reexamine a specific patient sample using a different method or a different technologist.

Answer 42

Internal split sample

Question 43

Analyze the same sample over time to assess the reproducibility and stability of a method

Answer 43

Audit sample

Question 44

What phases of testing are evaluated by quality control and by quality assurance?

Answer 44

Pre-analytic factors, analytical factors, and post-analytical factors

Question 45

Evaluates the daily precision of assay measurements

Answer 45

Internal QC or statistical QC

Question 46

Evaluates the accuracy of assay measurements. Use data generated from voluntary submission of internal QC control assay results and data generated from required submission of specific control specimen.

Answer 46

External QC

Question 47

Which westgard multirules detect random error?

Answer 47

1(3s) and R(4s)

Question 48

Which westgard multirules detect systematic errors?

Answer 48

2(2s), 4(1s) and 10(x)

Question 49

List the 9 nonanalytical factors that support quality testing

Answer 49

- Qualified personal - Established laboratory policies - Laboratory procedure manual - Test requisitioning - Patient identification, specimen procurement and labeling - Proper procedure for specimen collection and storage - Specimen transportations and processing - PM of equipment - Appropriate methodology

Question 50

Errors that are occurring over a period of time. - Change in the mean of the control values - Gradual and demonstrated as a trend in control values - Abrupt and demonstrated as a shift in control values

Answer 50

Systematic error

Question 51

An unpredictable error with no obvious pattern. It can occur by chance alone. - An unexpected deviation away from the calculated mean - There is acceptable(expected) random error as defined and quantified by standard deviation. - There is unacceptable(unexpected) random error that is any data point outside the expected population of data.

Answer 51

Random error

Question 52

- Detecting errors in equipment reagents, or individuals techniques. - Confirming the stability and accuracy of testing compared with reference values. - An increase in the frequency of both high and low minimally acceptable values (Dispersion - Progressive drift with a statistical trends. An abrupt shift with an average value of 3 days

Answer 52

Control specimen

Question 53

According to CLIA regulations, a minimum of____ control specimen must be run in every 24 hour period when patient specimen are being run

Answer 53

2

Question 54

What length of time would qualify as a shift or trend in QC data when looking at a levey-jenning chart?

Answer 54

3 days

Question 55

Represents a specimen with a known value that is similar in composition to, for example patients blood. The best to measure of precision and may represent normal or abnormal values.

Answer 55

Control

Question 56

Highly purified substance of a known composition. Best way to measure accuracy.

Answer 56

Standard

Question 57

Used in part to account for certain unavoidable error caused by sampling variability and imprecision of the methods themselves.

Answer 57

Confidence intervals (95%)

Question 58

A comprehensive set of policies, procedures, and practices is necessary to ensure the lab's results are reliable. To monitor and evaluate the overall quality of the total testing process (pre-analytical, analytical. and post-analytical)

Answer 58

Quality assurance

Question 59

The agreement among replicate measurements aka how close the single values are to one another.

Answer 59

Precision

Question 60

The agreement between the measured quantity and its true value aka how close the value is to the "true" value

Answer 60

Accuracy

Question 60

Used to identify unacceptable runs and then to evaluate the source and magnitude of the deviation to decide whether results are to be released to patient charts

Answer 60

Levey-Jennings QC Chart

Question 61

A voluntary process by which a nongovernmental agency grants recognition to an individual who has met certain education requirements and demonstrated entry-level competency by examination

Answer 61

Certification

Question 62

A mandatory process by which some states(government regulated) grant permission to an individual or organization to engage in a given occupation

Answer 62

Licensure

Question 63

- Proficiency Testing Programs - Management of patient testing - Quality assessment programs - Quality Control systems -Personal Requirements -Inspections and site visits -Consultations

Answer 63

CLIA 88 Regulations

Question 64

- Deterioration of the instrument light source - Gradual accumulation of debris in sample/reagent tubing - Gradual accumulation of debris on electrode surfaces - Aging of reagents - Gradual deterioration of control materials, incubation chamber temperature(enzymes only), light filter integrity, and calibration.

Answer 64

Causes of Trending

Question 65

- Sudden failure or change in the light source - Change in reagent formation or lot - Major instrument maintenance Sudden change in incubation temperature(enzymes only), room temperature, or humidity - Failure in the sampling system or in reagent dispense system -Inaccurate calibration/recalibration

Answer 65

Causes of Shifting

Question 66

Normal group of individuals free from disease and represents 95% of the population

Answer 66

Reference interval (normal range, normal value, reference range)

Question 67

- Testing the abilities, skills, knowledge of the individual -Known(previous tested) sample - Focuses on the individual performing patient testing; Does the person possesses the skill and knowledge to report accurate results? - Checked semiannually during the first year of employment and annually thereafter

Answer 67

Competency

Question 68

- Testing the processes of the lab - Unknown samples - Focuses on the laboratory's ability to report accurate test results and compares the lab's results to peer lab, reference standards, or reference labs - Performed periodically throughout the year for most tests performed and rotated among staff

Answer 68

Proficiency

Question 69

1. Direct observations of routine patient testing to include patient preparation(if applicable), specimen handling, processing and testing 2. Monitoring the reporting of test results 3. Review of intermediate test results or worksheet ,QC records, PT results, and preventive maintenance records. 4. Direct observations of performance of instrument maintenance and function checks 5. Assessment of testing performance through testing previously analyzed specimen, internal blind samples, or external PT samples. 6. Assessments of problem solving skills

Answer 69

6 areas of competency required by CLIA

Question 70

event where personnel could exercise more control

Answer 70

Adverse incident

Question 71

Risk management must report serious adverse incidents to the state within 15 days

Answer 71

CODE 15

Question 72

Occurrence that results in an unanticipated death or major loss of function unrelated to patient's current condition

Answer 72

Sentinel event

Question 73

Process variation for which a recurrence carries significant chance of a serous adverse event

Answer 73

Near Miss

Question 74

In-depth analysis of an occurrence by a multidisciplinary team if involved employees

Answer 74

Root Cause analysis