Compliance in Blood Bank

Question 1

DHHS

Answer 1

Health and human services

Question 2

FDA

Answer 2

food and drug associ. blood bank

Question 3

CBER

Answer 3

center for bio eval and research, regulates nations blood supply

Question 4

ORA

Answer 4

office of regulation affairs

Question 5

CDC

Answer 5

center for disease controls, DHQ

Question 6

OSHA

Answer 6

Occupational safety and health admin

Question 7

HCFA

CMS

Answer 7

health financing admin

CMS: medicare/medicade

Question 8

Oregon health authority

Answer 8

standard of quality for healthcare

Question 9

ISO

Answer 9

accredting agency,

internal organiz for standards (manufacutring)

Question 10

CAP

Answer 10

accrediting

college of american pathologists (tests/stds for labs)

Question 11

JCAHO

Answer 11

accrediting

joint comission o heathcare (safety and practices)

Question 12

AABB

Answer 12

Accrediting

americ assoc of blood banks

Question 13

Statues

Answer 13

laws made by gov to give athority to agencies/enforce regulations

Question 14

Regulations

Answer 14

define specifc minimum std that manufacturs must meet

Question 15

Guidence documents
what is put out by regulating agencies

Answer 15

stds put out by regulating agencies

Question 16

Applicable laws

Answer 16

CLIA, OSHA, PHS

CGMP (good manufacuturing practicies)

Question 17

Manufacturing facilities

Answer 17

except are transfusion services/transporters

unregistered facilities dont manufacture

inspections every 2yrs

(manufacturing includes packaging, labeling, testing…etc)

Question 18

Safety standards
must have process to monitor
d
b
dl
q
def

Answer 18

must have process to monitor
donor screen
blood test
donor list
quarantine
deficiencies

Question 19

Quality assurance

Answer 19

QC
reviews
procedures for varience
contractors FDA regulated

Question 20

Recalls

Answer 20

remove product communication/action taken
documented

Question 21

Fatality reporting

Answer 21

all transfusion associated fatalities

within 7 days

donation related deaths

Question 22

Look Backs
what service?
re
phy
fi

when are they done?
w new
new f
what deviations

Answer 22

transfusion service

recall notice
physician notification
final disposition

w new infections
new feratogen info
quality deviations

Question 23

Transfusion service quality assurance
dont have to have….

have s,a,r,q…

external inspection

internal inspection

Answer 23

dont have to have short supply plan

have SOPs audit, records, QC, maintence

External inspection: scheduled/deviations are corrected

Internal inspection: self inspection

Question 24

FDA reportable events

Answer 24

viral testing was not preformed
improper irradiation dose
labeled incorrectly

Question 25

When do you not report FDA events

Answer 25

product wasnt distrubuted event doesnt affect purity/potency outside of control from transfusion site

Question 26

SOPs

Answer 26

all tests certified to be preformed all accessible maintained/reviewed at least every 2 yrs blood bank 5yrs

Question 27

How long are validation records kept?

Answer 27

10yrs

Question 28

Managing temp storage devices

Answer 28

quarterly alarm clocl continuous alarms failure plans/balance...etc

Question 29

Preventing rgnt errors

Answer 29

expiration dates, QC visual, error (human)

Question 30

Automation parts that may fail

Answer 30

centrifuge camera tubing buffers arms/probes

Question 31

Records 10yr 5yr indefinite

Answer 31

legible/SOPs 10 yrs - blood type, AB ID, SOPS, QC 5yrs - training competency, audits indefinitie - deferrals, disease, transfusion reactions

Question 32

Training timeline

Answer 32

6 mos CLIA

Question 33

How often is QC monitored

Answer 33

reviewed quarterly samples centrifuged for 5-10 min

Question 34

blood utilization

Answer 34

lower transfusion threshold not indiacted until HGB 7g/dl blood order sets (>10g/dl not usually indicated)

Question 35

Order sets blood type type/screen type/cross emergency release

Answer 35

type: rhogam type/screen: prenatal/uncertain transfusion Type/cross: transfusion/ 1 unit increases hgb 1-2g/dl emergency - pt will expire if not transfused w in 60min