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Blood Bank II Summer > Compliance in Blood Bank > Flashcards

Compliance in Blood Bank Flashcards

1
Q

DHHS

A

Health and human services

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2
Q

FDA

A

food and drug associ. blood bank

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3
Q

CBER

A

center for bio eval and research, regulates nations blood supply

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4
Q

ORA

A

office of regulation affairs

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5
Q

CDC

A

center for disease controls, DHQ

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6
Q

OSHA

A

Occupational safety and health admin

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7
Q

HCFA

CMS

A

health financing admin

CMS: medicare/medicade

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8
Q

Oregon health authority

A

standard of quality for healthcare

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9
Q

ISO

A

accredting agency,

internal organiz for standards (manufacutring)

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10
Q

CAP

A

accrediting

college of american pathologists (tests/stds for labs)

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11
Q

JCAHO

A

accrediting

joint comission o heathcare (safety and practices)

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12
Q

AABB

A

Accrediting

americ assoc of blood banks

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13
Q

Statues

A

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

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14
Q

Regulations

A

define specifc minimum std that manufacturs must meet

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15
Q

Guidence documents
what is put out by regulating agencies

A

stds put out by regulating agencies

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16
Q

Applicable laws

A

CLIA, OSHA, PHS

CGMP (good manufacuturing practicies)

17
Q

Manufacturing facilities

A

except are transfusion services/transporters

unregistered facilities dont manufacture

inspections every 2yrs

(manufacturing includes packaging, labeling, testing…etc)

18
Q

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

A

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

19
Q

Quality assurance

A

QC
reviews
procedures for varience
contractors FDA regulated

20
Q

Recalls

A

remove product communication/action taken
documented

21
Q

Fatality reporting

A

all transfusion associated fatalities

within 7 days

donation related deaths

22
Q

Look Backs
what service?
re
phy
fi

when are they done?
w new
new f
what deviations

A

transfusion service

recall notice
physician notification
final disposition

w new infections
new feratogen info
quality deviations

23
Q

Transfusion service quality assurance
dont have to have….

have s,a,r,q…

external inspection

internal inspection

A

dont have to have short supply plan

have SOPs audit, records, QC, maintence

External inspection: scheduled/deviations are corrected

Internal inspection: self inspection

24
Q

FDA reportable events

A

viral testing was not preformed
improper irradiation dose
labeled incorrectly

25
Q

When do you not report FDA events

A

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

26
Q

SOPs

A

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

blood bank 5yrs

27
Q

How long are validation records kept?

A

10yrs

28
Q

Managing temp storage devices

A

quarterly alarm clocl
continuous alarms
failure plans/balance…etc

29
Q

Preventing rgnt errors

A

expiration dates, QC visual, error (human)

30
Q

Automation parts that may fail

A

centrifuge
camera
tubing
buffers
arms/probes

31
Q

Records
10yr

5yr

indefinite

A

legible/SOPs

10 yrs - blood type, AB ID, SOPS, QC

5yrs - training competency, audits

indefinitie - deferrals, disease, transfusion reactions

32
Q

Training timeline

A

6 mos
CLIA

33
Q

How often is QC monitored

A

reviewed quarterly

samples centrifuged for 5-10 min

34
Q

blood utilization

A

lower transfusion threshold

not indiacted until HGB 7g/dl

blood order sets

(>10g/dl not usually indicated)

35
Q

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

A

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

Blood Bank II Summer (9 decks)

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