compliance

Question 1

which of the following is the arm of the FDA involved in regulating the nation’s blood supply
- CBER
- AABB
- NIH
- JCAHO

Answer 1

CBER

Question 2

which of the following activities for quality assurance must be performed by the manufacturer but NOT the transfusion service
- quality control
- lookback
- short supply arrangements
- fatality reporting

Answer 2

short supply arragnments

Question 3

which of the following documents must only be maintained by the blood bank for 5 years
- donor deferrals
- recipient testing
- transfusion reactions
- proficiency testing

Answer 3

proficiency testing

Question 4

who should be monitoring blood inventory
- the manager
- the pathologist
- the physicians
- all blood bank staff

Answer 4

all blood bank staff

Question 5

which of the following is NOT a goal of blood utilization management
- better patient outcomes
- lower health care costs
- Foster respectful interactions between physicians and blood bankers
- utilize the nation’s blood supply efficiently

Answer 5

Foster respectful interactions between physicians and blood bankers

Question 6

what is required to ship blood products across state lines
- AABB accreditation
- state license
- CMS certification
- approved biologics license application

Answer 6

Approved biologics liscence application

Question 7

Which facility centered activity functions to minimize inappropriate transfusions?
- lookback
- patient blood management
- quality assurance
- cGMP

Answer 7

patient blood management

Question 8

Phenotype testing needs to be performed on a rare antiserum. What additional testing needs to be performed as QC?
- test antiserum with a panel
- test panel cells against a positive and negative control
- test the patient in duplicate
- test antiserum with a cell known to be positive and a cell known to be negative

Answer 8

• test antiserum with a cell known to be positive and a cell known to be negative

Question 9

according to Blood Utilization Management guidlines, when should a transfusion threshold of 8-10 g/dL be considered?
- when an oncologist requests it
- when the patient is experiencing symptomatic anemia
- for orthopedic surgery
- for hemophiliacs

Answer 9

• WHEN THE PATIENT IS EXPERIENCING SYMPTOMATIC ANEMIA

Question 10

what is CBER resposible for

Answer 10

regulation and enforcment of biological and related products quality standards - blood bank

Question 11

how did the PHS (Public Health Services Act) impact blood banking

Answer 11

grants authority to FDA to oversee blood and biologics

Question 12

if a facility is not a manufacturer, what body inspects them

Answer 12

• every 2 years by CMS

Question 13

when is a lookback performed

Answer 13

• new donor infectious disease info
• new donor teratogen info
• manufacturer quality deviations

Question 14

what patients are indicated for a transfusion under patient blood management guidelines with a hemoglobin of <6 g/dL

Answer 14

• always recommended

Question 15

what patients are indicated for a transfusion under patient blood management guidelines with a hemoglobin of 6-7 g/dL

Answer 15

transfusion generally indicated

Question 16

what patients are indicated for a transfusion under patient blood management guidelines with a hemoglobin of 7-8 g/dL

Answer 16

• orthopedic or cardiac surgery
• cardiovascular disease

Question 17

what patients are indicated for a transfusion under patient blood management guidelines with a hemoglobin of 8-10 g/dL

Answer 17

• generally not indicated
• symptomatic anemia
• ongoing bleeding
• acute coronary syndrome with ischemia
• oncology w/ risk of bleeding

Question 18

what patients are indicated for a transfusion under patient blood management guidelines with a hemoglobin of >10 g/dL

Answer 18

not indicated except in exceptional circumstances