Question 1

What is the main purpose of linking Current Good Manufacturing Practices (CGMPs) to process control?&#10;A) To comply with the regulations&#10;B) To build quality into the manufacturing process from the beginning to the end&#10;C) To review and approve training programs and employee position descriptions&#10;D) To approve raw test materials and in-house reagents

Accepted Answer

The main purpose of linking CGMPs to process control is to build quality into the manufacturing process from the beginning to the end. While complying with regulations is important, the ultimate goal is to ensure that the final product meets quality standards and is safe for consumer use. The other options listed (reviewing and approving training programs, approving raw test materials and in-house reagents) may be part of the overall quality control process, but they are not the main purpose of linking CGMPs to process control.

Question 2

Process improvement teams address all of the following issues except:&#10;A) becoming &#34;team players.&#34;&#10;B) quality and reliability of service.&#10;C) filing a grievance.&#10;D) interdepartmental communication.

Accepted Answer

Process improvement teams focus on enhancing various aspects of organizational performance such as teamwork, service quality, reliability, and communication across departments. Filing a grievance, however, is typically a matter handled through specific HR procedures or protocols, not a process improvement team's responsibility.

Question 3

When a new assay is implemented, what measure is taken to determine equivalency?&#10;A) Lot to lot testing of new and old lot numbers of reagent&#10;B) Work-flow reorientation&#10;C) Daily quality control&#10;D) Calibration

Accepted Answer

Lot to lot testing of new and old lot numbers of reagent is a measure taken to determine equivalency when a new assay is implemented. This ensures that the new assay performs similarly to the old one, maintaining consistency in test results.

Question 4

Which of the following might lead to unacceptable quality control results?&#10;A) A technician who has not worked in the area for several months&#10;B) A deteriorated &#34;Anti-A&#34;&#10;C) An uncalibrated serofuge&#10;D) All of the above

Accepted Answer

All of the listed factors can lead to unacceptable quality control results. 
A technician who has not worked in the area for several months may not have the necessary skills and knowledge to perform the testing accurately. 
A deteriorated "Anti-A" can result in inaccurate results, as the reagent may not be effective at detecting the presence of the antigen. 
An uncalibrated serofuge can also produce inaccurate results, as the device may not be properly measuring or separating the components in the sample.

Question 5

A standard operating procedure (SOP) is:&#10;A) a statement of intent or course of action.&#10;B) a description of resources and activities that transform inputs into outputs.&#10;C) a set of directions for how to perform a particular task.&#10;D) a form on which to record results.

Accepted Answer

A standard operating procedure (SOP) is a set of step-by-step instructions that describes how to perform a particular task or activity. SOPs are typically used in a variety of fields, including manufacturing, healthcare, and government agencies, to ensure that tasks are performed consistently and safely. A statement of intent, description of resources and activities, or a form for recording results may be part of an SOP, but the primary purpose of an SOP is to provide clear directions for performing a task.

Question 6

A physician complains that she has not received a test report from the blood bank. The remedial action is to:&#10;A) complete the occurrence report form.&#10;B) prepare a copy of the report for the physician.&#10;C) locate the original report.&#10;D) determine why the report was not delivered.

Accepted Answer

Preparing a copy of the report for the physician is the best remedial action as it directly resolves the physician's complaint and provides her with the requested information. Completing an occurrence report form, locating the original report, and determining why the report was not delivered may all be relevant steps to take but are not the most immediate and effective way to address the physician's concern.

Question 7

Which of the following statements concerning equipment is true?&#10;A) Requires software to function&#10;B) Quality control is not needed for critical steps.&#10;C) Frequency of testing is determined by manufacturer recommendations.&#10;D) All equipment must be purchased from the manufacturer.

Accepted Answer

The frequency of testing for equipment is typically determined by the manufacturer recommendations, as they know the specific requirements and limitations of their equipment. Therefore, it is important to follow these recommendations to ensure the equipment is functioning properly and producing accurate results. A) is not always true as some equipment may function without software. B) is incorrect as quality control is always needed for critical steps to ensure accuracy and reliability of results. D) is not true as equipment can be purchased from authorized distributors or third-party vendors.

Question 8

How do internal assessments differ from compliance inspections?&#10;A) Compliance inspections assess performance on quality indicators.&#10;B) Internal assessments focus on meeting regulations.&#10;C) Internal assessments are more frequent than compliance inspections.&#10;D) Compliance inspections seek underlying causes of problems.

Accepted Answer

Internal assessments are typically conducted more frequently than compliance inspections to ensure ongoing adherence to standards and to identify areas for improvement. Compliance inspections, on the other hand, are often scheduled by external bodies and may occur less frequently.

Question 9

Which statement concerning compliance programs is false?&#10;A) Programs are designed to evaluate effectiveness of blood bank laboratories.&#10;B) Programs provide an occasional opportunity to expose new and different problems.&#10;C) Compliance is synonymous with organization-wide quality assurance.&#10;D) Compliance inspections are conducted every 1 to 2 years.

Accepted Answer

The answer of Which statement concerning compliance programs is false?&#10;A)...

Question 10

All of the following are transfusion service quality assurance indicators used to monitor patient care except:&#10;A) labeling errors on specimens sent to the blood bank.&#10;B) reason for return of blood products.&#10;C) number of therapeutic units drawn.&#10;D) turnaround time on antibody identification.

Accepted Answer

While the other options all involve monitoring aspects of patient care related to transfusions, the number of therapeutic units drawn is not a quality assurance indicator. It may be an important factor to consider when monitoring blood usage, but it does not directly relate to patient safety or quality of transfusion services.

Question 11

Employee training takes place:&#10;A) before procedures are validated.&#10;B) after competence assessments.&#10;C) before flowcharting the process.&#10;D) after hiring and after implementing new procedures.

Accepted Answer

The answer of Employee training takes place:&#10;A) before procedures are...

Question 12

Which of the following is used to determine if reagents and equipment are functioning prior to testing?&#10;A) Critical control points&#10;B) Control charts&#10;C) Quality assurance&#10;D) Quality control

Accepted Answer

The answer of Which of the following is used to...

Question 13

Which of the following is an example of an external customer?&#10;A) A night-shift medical technologist&#10;B) A blood donor&#10;C) An intravenous nurse&#10;D) Housekeeping employee

Accepted Answer

The answer of Which of the following is an example...

Question 14

Which continuous improvement cycle component ensures the finished product has met required specifications?&#10;A) Improve&#10;B) Assess&#10;C) Implement&#10;D) Plan

Accepted Answer

The answer of Which continuous improvement cycle component ensures the...

Question 15

What department evaluates and certifies employee credentials and determines the literacy of the employee?&#10;A) Human Resources&#10;B) Laboratory&#10;C) Administration&#10;D) Education

Accepted Answer

The answer of What department evaluates and certifies employee credentials...

Question 16

What phase is synonymous with &#34;quality management&#34;?&#10;A) Good manufacturing practice&#10;B) Organization-wide quality assurance&#10;C) Process improvement team&#10;D) Quality control

Accepted Answer

The answer of What phase is synonymous with &#34;quality management&#34;?&#10;A)...

Question 17

Blood collected in a red-top tube and a lavender tube was sent through a tube system to the STAT laboratory. The blood specimens were not labeled with any type of patient identification. The medical technologist called the emergency room (ER) to notify them of the problem. The ER nurse stated she wanted the tubes sent back to the ER and that she would label them. The stat laboratory technologist related the laboratory's policy on unlabeled specimens, saying that they would be discarded. At that point the disgruntled nurse said she would write up a(n) for the laboratory's refusal to analyze blood on an emergency patient.

A) employee evaluation
B) incident report
C) patient report
D) flow chart

Accepted Answer

The answer of Blood collected in a red-top tube and...

Question 18

What is a function of the quality committee or quality council?&#10;A) To provide solutions to recurring clerical errors&#10;B) To provide counseling for departmental downsizing&#10;C) To set priorities for quality improvements&#10;D) To focus on computer upgrades and software implementation

Accepted Answer

The answer of What is a function of the quality...

Question 19

Which of the following is not regarded as an instrument?&#10;A) Automated analyzer&#10;B) Pipette&#10;C) Washer&#10;D) Cuvette

Accepted Answer

The answer of Which of the following is not regarded...

Question 20

As part of postemployment departmental training, a medical technologist was given 10 known blood samples to analyze for ABO specificity. This is referred to as:&#10;A) recertification.&#10;B) a competence assessment.&#10;C) education.&#10;D) a proficiency test.

Accepted Answer

The answer of As part of postemployment departmental training, a...

Deck 23: Quality Management