Deck 43: Quality Assessment in the Hematology Laboratory

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Question
A CBC is received from the ICU and assayed STAT on the hematology analyzer. The CBC results show an MCHC of 42 g/dl. What is your next step?

A) Call ICU for a new sample
B) Repeat the assay and report the result, commenting it was verified by repeat analysis
C) Warm the tube to 37°C and rerun to correct for cold agglutinin.
D) Check for clots and repeat the assay
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Question
The TAT is being monitored for CBC reporting on samples from the critical care units. This monitor fits into which patient safety goal?

A) Efficiency
B) Effectiveness
C) Safety
D) Timely
Question
A CBC is performed on a patient with a strong cold agglutinin. The MCHC is >40 g/dl and warming the sample does not correct the MCHC. The laboratory professional performs a manual hematocrit (mHCT) on the sample. What values can be reported on the CBC?

A) All parameters except the instrument HCT which is replaced with the mHCT
B) WBC, RBC, HGB, mHCT, PLT
C) WBC, HBG, mHCT, PLT
D) Nothing can be reported; reject the sample
Question
Proficiency testing is a type of:

A) Internal quality control
B) External quality control
C) Competency assessment
D) Instrument QC
Question
Control values for the PT reagent have been established as: Level 1: mean - 10.4, 1sd - 0.6; Level 3: mean - 24.6, 1 sd - 1.8. Control values for the morning QC were Level 1: 11.7; Level 3: 28.9. What is the next step?

A) Proceed with patient testing, QC is acceptable
B) Both controls are above acceptable range, rerun controls
C) Both controls are above acceptable range, check reagents for correct placement on the analyzer and correct handling. Correct problem before proceeding
D) Proceed with patient testing, Level 1 is within 3 sd.
Question
Under the CLIA '88 regulations, documentation of instrument maintenance must be:

A) Kept in locked files in the manager's office
B) Published in the laboratory communication on a monthly basis
C) Easily accessible for troubleshooting instrument issues
D) Only done on night shift
Question
Drawing blood from an IV site is classified as:

A) Pre-examination error
B) Examination error
C) Post-examination error
D) Random error
Question
The mean and control limits are used to construct QC charts known as:

A) Levey-Jennings charts
B) Leslie Johnson charts
C) Westgard charts
D) Linear regression charts
Question
All of the following Westgard rules identify systematic error except:

A) 22s for across runs
B) 10x for across runs
C) 13s for within run
D) 22s for within run
Question
What parameter(s) is(are) used to assess an instrument's analytical reliability?

A) Random and systematic variation
B) Linear regression
C) AMR and linearity
D) Reference intervals
Question
An IQCP program includes risk assessment as one of its three components. Which of the following is covered in a risk assessment analysis?

A) Specimen
B) Environment
C) Testing personnel
D) All of the above
Question
The daily QC protocol for the hematology analyzer includes 2 levels of assayed commercial control for every 8 hours of patient testing plus a normal patient control every 4 hours. What does the normal patient control monitor?

A) Instrument precision
B) Instrument accuracy
C) Instrument linearity
D) Accuracy of the manufacturer QC material
Question
Which federal agency originally introduced and continues to oversee the universal precautions guidelines?

A) CMS
B) OSHA
C) CDC
D) FDA
Question
The most likely cause of a delta check alarm is due to either random error or:

A) Lipemia
B) Hemolysis
C) Specimen mislabeling
D) Old blood
Question
Specimens are received from the emergency room for CBC, PT, PTT, and Chem panel. Coag results are PT - 7.0 sec (ref range: 9.0-11.2 sec), PTT - 18.9 sec (ref range: 26.0-32.0 sec). What could explain these results?

A) The patient just runs low
B) The specimen is lipemic
C) The coag tube was drawn after the SST tube
D) The coag tube was underfilled
Question
A new lot of APTT reagent is being evaluated and the following data points have been gathered to validate the reference range. Values: 32.6, 30.4, 33.7, 29.8, 30.7, 30.4, 32.5, 31.8, 29.6, 33.4, 31.9, 30.7, 32.6, 29.9, 30.9, 31.2, 33.1, 32.9, 28.6, 29.9. Given this information, what is the new reference range?

A) 26.3-33.1
B) 30.2-36.8
C) 28.5-34.1
D) 29.1-34.9
Question
The SDS will must contain all of the following information except:

A) Storage and disposal requirements
B) Handling precautions
C) Health hazards
D) Shipping requirements
Question
The Health Insurance Portability and Accountability Act (HIPAA) regulates:

A) Quality Control procedures
B) Procedure manual standards
C) Patient confidentiality
D) Personnel standards
Question
Which federal agency introduced the Blood-borne Pathogens Standards that require educating and training laboratory employees, implementing an exposure control plan, and using a record-keeping mechanism?

A) CMS
B) OSHA
C) CDC
D) FDA
Question
'Moving Averages' is a method using what parameter(s) to monitor hematology instrument performance on a continual basis?

A) WBC count
B) Platelet count
C) RBC indices
D) MPV
Question
List the six IOM healthcare quality aims and state the definition of each.
Question
List the three components that make up a comprehensive Quality Assurance program and list four sub-components under each major heading.
Question
Differentiate between Quality Assessment and Quality Control and explain why they are necessary.
Question
When evaluating a new method or instrument, linear regression analysis is used to detect systematic and random errors. The observation of a constant systematic error usually indicates what?

A) Sample handling problem
B) Calibration problem
C) Instrument or reagent problem
D) Calculation problem
Question
Samples are received from the emergency department for CBC, Chem panel and 'hold' coag tubes. The CBC is assayed and the MCHC is 38.4 g/dl. The "hold" coag tube is centrifuged and the laboratory professional observes that the plasma is opaque and milky in appearance. What are the next steps?

A) Release results commenting that results may be inaccurate
B) Perform saline replacement to obtain accurate HGB, calculate new MCH, MCHC, release results with corrected HGB, MCH, MCHC
C) Release the results and phone the 'critical value'
D) Ask for a redraw
Question
While running a CBC on the hematology analyzer, the platelet count is flagged for thrombocytopenia and possible interference. On reviewing the peripheral smear, many grapelike clusters are noted on the smear. What is your next step?

A) Recollect the CBC in sodium citrate and multiply the platelet count by 1.1 before reporting the result
B) Reject the specimen, and state the platelets are inaccurate
C) Report the CBC with no additional action
D) Recollect the CBC in sodium heparin
Question
Describe necessary components of a laboratory's response to unsatisfactory performance on proficiency testing challenges.
Question
What are the six elements of a competency assessment program as identified by CLIS '88?
Question
Your hematology laboratory is installing a new analyzer and you are responsible for validating the instrument reportable range. The manufacturer has supplied you with a linearity kit which spans the entire stated reportable range but after assaying the kit, you are getting unacceptable values for the upper end of the WBC reportable range. The manufacturer states the WBC range is 0-100.0 × 109/L but your results become non-linear at an upper value of 91.0 × 109/L. What are your next steps? What will you set for your lab's reportable range for WBC on the new analyzer?
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Deck 43: Quality Assessment in the Hematology Laboratory
1
A CBC is received from the ICU and assayed STAT on the hematology analyzer. The CBC results show an MCHC of 42 g/dl. What is your next step?

A) Call ICU for a new sample
B) Repeat the assay and report the result, commenting it was verified by repeat analysis
C) Warm the tube to 37°C and rerun to correct for cold agglutinin.
D) Check for clots and repeat the assay
Warm the tube to 37°C and rerun to correct for cold agglutinin.
2
The TAT is being monitored for CBC reporting on samples from the critical care units. This monitor fits into which patient safety goal?

A) Efficiency
B) Effectiveness
C) Safety
D) Timely
Timely
3
A CBC is performed on a patient with a strong cold agglutinin. The MCHC is >40 g/dl and warming the sample does not correct the MCHC. The laboratory professional performs a manual hematocrit (mHCT) on the sample. What values can be reported on the CBC?

A) All parameters except the instrument HCT which is replaced with the mHCT
B) WBC, RBC, HGB, mHCT, PLT
C) WBC, HBG, mHCT, PLT
D) Nothing can be reported; reject the sample
WBC, HBG, mHCT, PLT
4
Proficiency testing is a type of:

A) Internal quality control
B) External quality control
C) Competency assessment
D) Instrument QC
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k this deck
5
Control values for the PT reagent have been established as: Level 1: mean - 10.4, 1sd - 0.6; Level 3: mean - 24.6, 1 sd - 1.8. Control values for the morning QC were Level 1: 11.7; Level 3: 28.9. What is the next step?

A) Proceed with patient testing, QC is acceptable
B) Both controls are above acceptable range, rerun controls
C) Both controls are above acceptable range, check reagents for correct placement on the analyzer and correct handling. Correct problem before proceeding
D) Proceed with patient testing, Level 1 is within 3 sd.
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6
Under the CLIA '88 regulations, documentation of instrument maintenance must be:

A) Kept in locked files in the manager's office
B) Published in the laboratory communication on a monthly basis
C) Easily accessible for troubleshooting instrument issues
D) Only done on night shift
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
7
Drawing blood from an IV site is classified as:

A) Pre-examination error
B) Examination error
C) Post-examination error
D) Random error
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
8
The mean and control limits are used to construct QC charts known as:

A) Levey-Jennings charts
B) Leslie Johnson charts
C) Westgard charts
D) Linear regression charts
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k this deck
9
All of the following Westgard rules identify systematic error except:

A) 22s for across runs
B) 10x for across runs
C) 13s for within run
D) 22s for within run
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
10
What parameter(s) is(are) used to assess an instrument's analytical reliability?

A) Random and systematic variation
B) Linear regression
C) AMR and linearity
D) Reference intervals
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
11
An IQCP program includes risk assessment as one of its three components. Which of the following is covered in a risk assessment analysis?

A) Specimen
B) Environment
C) Testing personnel
D) All of the above
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
12
The daily QC protocol for the hematology analyzer includes 2 levels of assayed commercial control for every 8 hours of patient testing plus a normal patient control every 4 hours. What does the normal patient control monitor?

A) Instrument precision
B) Instrument accuracy
C) Instrument linearity
D) Accuracy of the manufacturer QC material
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
13
Which federal agency originally introduced and continues to oversee the universal precautions guidelines?

A) CMS
B) OSHA
C) CDC
D) FDA
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
14
The most likely cause of a delta check alarm is due to either random error or:

A) Lipemia
B) Hemolysis
C) Specimen mislabeling
D) Old blood
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
15
Specimens are received from the emergency room for CBC, PT, PTT, and Chem panel. Coag results are PT - 7.0 sec (ref range: 9.0-11.2 sec), PTT - 18.9 sec (ref range: 26.0-32.0 sec). What could explain these results?

A) The patient just runs low
B) The specimen is lipemic
C) The coag tube was drawn after the SST tube
D) The coag tube was underfilled
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
16
A new lot of APTT reagent is being evaluated and the following data points have been gathered to validate the reference range. Values: 32.6, 30.4, 33.7, 29.8, 30.7, 30.4, 32.5, 31.8, 29.6, 33.4, 31.9, 30.7, 32.6, 29.9, 30.9, 31.2, 33.1, 32.9, 28.6, 29.9. Given this information, what is the new reference range?

A) 26.3-33.1
B) 30.2-36.8
C) 28.5-34.1
D) 29.1-34.9
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Unlock for access to all 29 flashcards in this deck.
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k this deck
17
The SDS will must contain all of the following information except:

A) Storage and disposal requirements
B) Handling precautions
C) Health hazards
D) Shipping requirements
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
18
The Health Insurance Portability and Accountability Act (HIPAA) regulates:

A) Quality Control procedures
B) Procedure manual standards
C) Patient confidentiality
D) Personnel standards
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
19
Which federal agency introduced the Blood-borne Pathogens Standards that require educating and training laboratory employees, implementing an exposure control plan, and using a record-keeping mechanism?

A) CMS
B) OSHA
C) CDC
D) FDA
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
20
'Moving Averages' is a method using what parameter(s) to monitor hematology instrument performance on a continual basis?

A) WBC count
B) Platelet count
C) RBC indices
D) MPV
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
21
List the six IOM healthcare quality aims and state the definition of each.
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
22
List the three components that make up a comprehensive Quality Assurance program and list four sub-components under each major heading.
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
23
Differentiate between Quality Assessment and Quality Control and explain why they are necessary.
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
24
When evaluating a new method or instrument, linear regression analysis is used to detect systematic and random errors. The observation of a constant systematic error usually indicates what?

A) Sample handling problem
B) Calibration problem
C) Instrument or reagent problem
D) Calculation problem
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
25
Samples are received from the emergency department for CBC, Chem panel and 'hold' coag tubes. The CBC is assayed and the MCHC is 38.4 g/dl. The "hold" coag tube is centrifuged and the laboratory professional observes that the plasma is opaque and milky in appearance. What are the next steps?

A) Release results commenting that results may be inaccurate
B) Perform saline replacement to obtain accurate HGB, calculate new MCH, MCHC, release results with corrected HGB, MCH, MCHC
C) Release the results and phone the 'critical value'
D) Ask for a redraw
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
26
While running a CBC on the hematology analyzer, the platelet count is flagged for thrombocytopenia and possible interference. On reviewing the peripheral smear, many grapelike clusters are noted on the smear. What is your next step?

A) Recollect the CBC in sodium citrate and multiply the platelet count by 1.1 before reporting the result
B) Reject the specimen, and state the platelets are inaccurate
C) Report the CBC with no additional action
D) Recollect the CBC in sodium heparin
Unlock Deck
Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
27
Describe necessary components of a laboratory's response to unsatisfactory performance on proficiency testing challenges.
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
28
What are the six elements of a competency assessment program as identified by CLIS '88?
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
29
Your hematology laboratory is installing a new analyzer and you are responsible for validating the instrument reportable range. The manufacturer has supplied you with a linearity kit which spans the entire stated reportable range but after assaying the kit, you are getting unacceptable values for the upper end of the WBC reportable range. The manufacturer states the WBC range is 0-100.0 × 109/L but your results become non-linear at an upper value of 91.0 × 109/L. What are your next steps? What will you set for your lab's reportable range for WBC on the new analyzer?
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Unlock for access to all 29 flashcards in this deck.
Unlock Deck
k this deck
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Unlock Deck
Unlock for access to all 29 flashcards in this deck.