[22] CHAPTER IX LESSON 4

Question 1

When discussing Quality Programs, it includes:

Answer 1

Quality Control
Quality Assurance
Quality Improvement

Question 2

For Blood Banking Quality Programs are essential requirements of 2 Federal Agencies:

Answer 2

1. Centers for Medicare and Medicaid Systems (CMS)
2. Food and Drug Administration

Question 3

formerly HCFA, under CLIA-88 which covers all Clinical Laboratory activities and related federal payments

Answer 3

1. Centers for Medicare and Medicaid Systems (CMS)

Question 4

2. Food and Drug Administration that has the following concerns:
   a. Responsibilities of the [?] (anticoagulants and preservatives, shelf life etc.)
   b. Specific requirements related to independent [?] for overall quality of blood products and the processes related to dispersion of those products.

Answer 4

blood product requirements

quality control and quality assurance

Question 5

A number of accrediting agents have quality requirements as well:

Answer 5

1. American Association of Blood Banks (Blood Banks and Transfusion Services)
2. Joint Commission on the Accreditation of Healthcare Organizations
3. College of American Pathologists

Question 6

SOP’s - Standard Operating Procedures

Answer 6

AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization

Question 7

Training plans and development of procedures

Answer 7

AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization

Question 8

Approval of lot release of reagents and quality control reagents

Answer 8

AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization

Question 9

Review and approval of practices relating to personnel, equipment, selection of suppliers, process control, final inspection and handling nonconforming components, methods in place for handling incidents, errors, and accidents.

Answer 9

AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments Organization

Question 10

Methods for hiring of qualified personnel needs to be in place

Answer 10

Personnel Practices

Question 11

Job descriptions for all positions need to exist and be available

Answer 11

Personnel Practices

Question 12

Training program and full documentation of that training for new and continuous employees.

Answer 12

Personnel Practices

Question 13

Whenever a new procedure or instrument is implemented a training program needs to be in place.

Answer 13

Personnel Practices

Question 14

Regular competency evaluations including direct observation and documentation of such must occur.

Answer 14

Personnel Practices

Question 15

Validation of new equipment

Answer 15

Equipment

Question 16

Calibration and preventative maintenance including standard equipment like refrigerators, complex equipment and computer systems

Answer 16

Equipment

Question 17

Continual monitoring of blood bank refrigerators extremely important in both blood centers and transfusion services

Answer 17

Equipment

Question 18

According to AABB, the following criteria and documentation must be in place in the individual laboratory.
 List of [?]
 Clearly defined [?]
 Evaluation of [?] to meet requirements
 Included: requirements for [?] to notify facility of changes
 Prior to use of [?] they need to be tested.
 Determination needs to be made relating to whether they are satisfactory for [?]
 Documentation of [?]
 Documentation of [?] needs to done by facility before being put into use and prior to each use for reagents related to ABO, Rh, antibody screening and infectious diseases before being used for patient or donor testing. (See attached worksheet for daily QC of blood bank reagents.)

Answer 18

critical supplies and services

requirements

suppliers qualifications

manufacturer mechanisms

incoming supplies

intended use

package, storage and transportation

testing

Question 19

Development of SOP

Answer 19

Process control, final inspection, and handling elements

Question 20

Control of changes in policies, processes or procedures

Answer 20

Process control, final inspection, and handling elements

Question 21

Acceptance testing to new/revised software involved in blood bank procedures

Answer 21

Process control, final inspection, and handling elements

Question 22

Validation of new policies, processes or procedures

Answer 22

Process control, final inspection, and handling elements

Question 23

Monitoring and control of production processes

Answer 23

Process control, final inspection, and handling elements

Question 24

Participation in proficiency testing appropriate for each testing system in place

Answer 24

Process control, final inspection, and handling elements

Question 25

Established QC procedures for supplies and equipment

Answer 25

Process control, final inspection, and handling elements

Question 26

Supplier qualifications and product specification need to be in place

Answer 26

Process control, final inspection, and handling elements

Question 27

Control processes for nonconforming blood and blood components and products.

Answer 27

Process control, final inspection, and handling elements

Question 28

Documents and records have 4 levels

Question 29

relate to "What to do" in response to various situations

Answer 29

1. Policies (Level 1)

Question 30

relate to "How it happens"

Answer 30

2. Processes (Level 2)

Question 31

"How to do it"

Answer 31

3. Procedures (Level 3)

Question 32

that need to be completed when you are performing the procedures and following the processes and policies.

Answer 32

4. Forms/Records, Supporting Documents etc. (Level 4)

Question 33

Process to capture incidents, errors etc.

Answer 33

Incidents, errors, and accidents

Question 34

If incident occurs, the severity of the incident is determined by the facility

Answer 34

Incidents, errors, and accidents

Question 35

: "What is the likelihood it will happen again?" and what to do about it if it could happen again

Answer 35

If it is a one-time incident

Question 36

"What might be the root cause?"

Answer 36

If there are multiple similar incidents

Question 37

Develop processes for continuous improvement to help eliminate both one-time incidents and multiple similar incidents.

Answer 37

Incidents, errors, and accidents

Question 38

includes both internal and external assessment

Answer 38

Quality Assessment Program

Question 39

includes blood usage review committees within a hospital (transfusion audits) or institutional QA teams

Answer 39

Internal assessment

Question 40

include inspections, surveys, proficiency surveys performed by agencies like the FDA, AABB, and CAP

Answer 40

External assessments

Question 41

Corrective actions that are educational not punitive

Answer 41

Process improvement

Question 42

Timely corrections

Answer 42

Process improvement

Question 43

Yearly reports relating to QA and CQI committees

Answer 43

Process improvement

Question 44

Although both transfusion services and blood centers are primarily concern with safe transfusions and related issues, there also needs to be processes in place related to employee safety

Answer 44

Facilities and safety

Question 45

Compliance with OSHA requirements: chemical and biologic

Answer 45

Facilities and safety

Question 46

Disaster preparedness

Answer 46

Facilities and safety

Question 47

Adequate space and ventilation

Answer 47

Facilities and safety

Question 48

Adequate sanitation and water systems etc.

Answer 48

Facilities and safety

Question 49

Evaluations of limitations of physical structure prior to implementation of new equipment or processes

Answer 49

Facilities and safety

Question 50

An allogeneic blood donor should weigh at least

Answer 50

110 lbs (50 kg).

Question 51

The minimum hemoglobin for a female whole blood donor is

Answer 51

12.5 g/dL.

Question 52

The minimum hemoglobin for a male whole blood donor is

Answer 52

13.0 g/dL.

Question 53

Persons who have had a blood transfusion are deferred for [?] owing to risk of exposure to hepatitis, HIV, or other viral diseases.

Answer 53

12 months

Question 54

The interval between whole blood donations is [?].

Answer 54

8 weeks or 56 days

Question 55

The interval between plasmapheresis, plateletpheresis, or leukapheresis is at least [?].

Answer 55

2 days

Question 56

Attenuated live viral vaccines such as smallpox, measles, mumps, yellow fever, and influenza carry a [?] deferral.

Answer 56

2-week

Question 57

A blood donor that has a positive serologic test for syphilis is deferred for [?].

Answer 57

12 months

Question 58

refers to blood for the donor-patient that is drawn before an anticipated transfusion for surgery and stored until used.

Answer 58

Predeposit autologous donation

Question 59

An autologous donor must have a hemoglobin of at least [?] and a hematocrit of at least [?].

Answer 59

11.0 g/dL 33%

Question 60

A person who has received a nonhuman animal trans plant of cells or tissues is [?] deferred from donating whole blood.

Answer 60

permanently

Question 61

Males who have had sex with another male (MSM) in the past 12 months are deferred for [?].

Answer 61

1 year

Question 62

Acute normovolemic hemodilution takes place in the operating room when [?] of whole blood are collected and the patient’s volume is replaced with colloid or crystalloid, then reinfused during surgical procedure, starting with the first unit collected.

Answer 62

1 to 3 units

Question 63

can be a powerful tool for a Blood Service if it is planned and implemented appropriately as a whole-of-business program that adds value to the entire Blood Service beyond meeting compliance

Answer 63

quality assurance program

Question 64

can ensure consistency of product, reliable results, effective risk-based decision-making and reduction in wastage through minimization of errors

Answer 64

quality assurance

Question 65

therefore provides a strong basis for donor, product and staff safety.

Answer 65

Quality assurance