Compliance in Blood Bank Flashcards
DHHS
Health and human services
FDA
food and drug associ. blood bank
CBER
center for bio eval and research, regulates nations blood supply
ORA
office of regulation affairs
CDC
center for disease controls, DHQ
OSHA
Occupational safety and health admin
HCFA
CMS
health financing admin
CMS: medicare/medicade
Oregon health authority
standard of quality for healthcare
ISO
accredting agency,
internal organiz for standards (manufacutring)
CAP
accrediting
college of american pathologists (tests/stds for labs)
JCAHO
accrediting
joint comission o heathcare (safety and practices)
AABB
Accrediting
americ assoc of blood banks
Statues
laws made by gov to give athority to agencies/enforce regulations
Regulations
define specifc minimum std that manufacturs must meet
Guidence documents
what is put out by regulating agencies
stds put out by regulating agencies
Applicable laws
CLIA, OSHA, PHS
CGMP (good manufacuturing practicies)
Manufacturing facilities
except are transfusion services/transporters
unregistered facilities dont manufacture
inspections every 2yrs
(manufacturing includes packaging, labeling, testing…etc)
Safety standards
must have process to monitor
d
b
dl
q
def
must have process to monitor
donor screen
blood test
donor list
quarantine
deficiencies
Quality assurance
QC
reviews
procedures for varience
contractors FDA regulated
Recalls
remove product communication/action taken
documented
Fatality reporting
all transfusion associated fatalities
within 7 days
donation related deaths
Look Backs
what service?
re
phy
fi
when are they done?
w new
new f
what deviations
transfusion service
recall notice
physician notification
final disposition
w new infections
new feratogen info
quality deviations
Transfusion service quality assurance
dont have to have….
have s,a,r,q…
external inspection
internal inspection
dont have to have short supply plan
have SOPs audit, records, QC, maintence
External inspection: scheduled/deviations are corrected
Internal inspection: self inspection
FDA reportable events
viral testing was not preformed
improper irradiation dose
labeled incorrectly
When do you not report FDA events
product wasnt distrubuted
event doesnt affect purity/potency
outside of control from transfusion site
SOPs
all tests certified to be preformed
all accessible
maintained/reviewed at least every 2 yrs
blood bank 5yrs
How long are validation records kept?
10yrs
Managing temp storage devices
quarterly alarm clocl
continuous alarms
failure plans/balance…etc
Preventing rgnt errors
expiration dates, QC visual, error (human)
Automation parts that may fail
centrifuge
camera
tubing
buffers
arms/probes
Records
10yr
5yr
indefinite
legible/SOPs
10 yrs - blood type, AB ID, SOPS, QC
5yrs - training competency, audits
indefinitie - deferrals, disease, transfusion reactions
Training timeline
6 mos
CLIA
How often is QC monitored
reviewed quarterly
samples centrifuged for 5-10 min
blood utilization
lower transfusion threshold
not indiacted until HGB 7g/dl
blood order sets
(>10g/dl not usually indicated)
Order sets
blood type
type/screen
type/cross
emergency release
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
