Ch. 9 - Quality management

Question 1

What regulatory bodies impose QA/QC requirements on blood banks?

Answer 1

CMS, CLIA, and FDA all require an independent QC or QA unit.

Question 2

What are ISO quality management standards?

Answer 2

ISO9001 is generic to any industry and describe the minimum elements of quality management.

ISO 15189 standards are specific to lab medicine.

Question 3

In general, what is quality control (QC)?

Answer 3

A means to detect and correct deficiencies in laboratory process to reduce errors and ensure adequate outputs.

Question 4

What are some examples of QC functions?

Answer 4

Reagent QC
Product QC
Clerical checks
Visual inspections
Internal measurements (temperature, cell counts)

Question 5

What is the purpose quality assurance (QA)?

Answer 5

Control processes, detected unwanted shifts or trends, and identify opportunities for process improvement.

Question 6

How does the FDA regulate blood establishments?

Answer 6

Under the Food, Drug, and Cosmetic Act of 1938 and the Public Health Service Act of 1944. Regulations include current good manufacturing practice (cGMP) and current good tissue practice (cGTP) regulations.

Question 7

How does CMS regulate blood establishments?

Answer 7

Under the Public Health Service Act of 1944 and CLIA’88, which provides accreditation through CAP or AABB inspection.

Question 8

What are Juran’s three fundamental processes in quality management?

Answer 8

Planning
Control
Improvement

Question 9

What steps are performed during the planning phase of quality management?

Answer 9

1. Establish quality goals for the project
2. Identify the customer
3. Determine customer needs and expectations
4. Develop product and service specifications to meet the requirements.
5. Develop operational processes for production and delivery.
6. Develop process controls and validation.

Question 10

What steps are performed during the control phase of quality management?

Answer 10

1. Evaluation of performance
2. Comparison of performance to goals
3. Action to correct any discrepancy between the two

Question 11

What is the “process approach”?

Answer 11

Input > Process > Output

Process includes all of the resources and activities that transform an input into an output.

Question 12

How can quality management principles be applied to organization and leadership?

Answer 12

Organizational structure should be documented with clearly defined roles, responsibilities, and hierarchies.

Question 13

How can quality management principles be applied to personnel?

Answer 13

Continuous education opportunities should be offered and recorded. Regular competency assessment and proficiency testing should be performed.

Question 14

How can quality management principles be applied to equipment management?

Answer 14

Choose the right equipment, install it correctly, ensure proper training, proper function, and a system for maintenance.

Question 15

How can quality management principles be applied to process management?

Answer 15

Integrate factors to ensure quality of lab testing processes, such as QC for testing, specimen collection and handling, verification and validation.

Question 16

How can quality management principles be applied to information management? Documents and records?

Answer 16

End-user validation of computer systems.

Reliable records in paper or electronic form, with processes to identify, approve, review, and retire records and SOPs.

Question 17

How can quality management principles be applied to nonconforming events?

Answer 17

QM system should include a process for detecting, investigating, and responding to events which deviate from policy.

Question 18

How can quality management principles be applied to process improvement?

Answer 18

Improve in a continuous and systemic manner, using tools such as customer service surveys, QC, QA, auditing, and quality indicators.

Question 19

How can quality management principles be applied to “focus on customers”?

Answer 19

Have an agreement or contract between client and facility. Have a means to obtain feedback to ensure expectations are being met.

Question 20

How can quality management principles be applied to facilities, work environment, and safety?

Answer 20

Provide a safe workplace with adequate environmental controls. This is required by cGMP (and others).