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This is the evaluation and monitoring of all aspects of a process or system to identify, correct, and prevent unacceptable results.
Quality assurance
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What are the seven goals of quality assurance?
- improve quality of care and patient safety
- to have safe blood transfusions
- encompass all processes
- decrease errors
- implement effective process and system control
- ensure product safety and quality
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this QA goal procets donors and patients from harm.
to have safe blood transfusions
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emcompassing all processes inclues what two things?
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what does GMP stand for?
good manufacturing processes
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what is the QA paradigm shift?
from service to manufacturer
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this is the QA system which oversees all processes.
quality assurance program
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this QA system includes DBSS, CHCS, and document control.
information management
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what does DBSS stand for?
defence blood standard system
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which QA system includes screening, unit typing, and patient ABO/Rh?
donor and patient testing
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which QA system includes testing prior to transfusion?
compatibility and type and screen
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which QA system includes transfusion?
blood administration
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which QA system includes transfusion reactions?
investigation of averse effects
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what QA system includes review proper documentation of transfusion.
Review and Labeling
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this is used to freeze blood
glycerin
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what does CPDA stand for?
Citrate Phosphate Dextrose Adenine
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which QA system includes frozen blood, CPDA, AdSol expiration dates?
storage and distribution
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what does FFP stand for?
Fresh frozen plasma
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which QA system includes testing, typing, and labeling of units?
component processing
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which QA system includes donor screening, and donor preparation?
blood collection
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which QA system includes patients who need phlebotomy for conditons such as polycythemia rubrivera?
therapeutic phlebotomy
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which QA system has a less stringent blood testing system and is made for patients who are donating blood to be used on themselves?
Autologous blood
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which QA system includes a donor screening process at blood drives?
allogenic donor suitability
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this is the QA system which is the removal of certain components in blood (platelets, plasma) and returning the rest back to the donor?
apheresis
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what year was the armed services blood program office (ASBPO) established?
1952
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the ASBPO coordinates blood program of military departments to do what two things?
- implement standarization
- coordination during mobilization
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what is the ASBP mission?
- provide blood
- in the right amountsto the right placeat the right timeat the right temperature
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what is the key to the ASBP mission?
figuring out how much, where and when
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what is the expiration date on liquid RBCs (CPDA-1)?
35 days
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what is the expiration date of liquid RBCs (AS-1 or AS-3)?
42 days
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what is the storage temperature for liquid RBCs?
1-6oC
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what is the shipment temperature for liquid RBCs?
1-10oC
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what is the licensed expiration for frozen RBCs?
10 years
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what is the contingency expiration for RBCs?
21 years
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what is the storage temperature for frozen RBCs?
<-65oC
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what is the shipment temperature for frozen RBCs?
<-40oC
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what is the expiration date post thaw, deglycerolization and washing for frozen RBCs?
14 days
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fresh frozen plasma must be processed within how many hours?
six
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what is the expiration for fresh frozen plasma and cryoprecipitate?
1 year
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what is the storage temperature for fresh frozen plasma and cryoprecipitate?
<-18oC
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what is the expiration for platelets?
5 days
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what are the storage reqirements for platelets?
- room temp
- constant rocking
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what temperature should platelets be stored at?
20-24oC
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these provide blood to meet military health system needs and continuing ops.
Blood donor centerss
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DoD collects _______ red blood cell units from military, family members, and DoD civilians annually.
120,000
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where are the two ASWBLs located?
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where are the six BDC's?
- NMC San Diego
- NCR ASBBC bethesda
- NMC portsmouth
- NH camp lejeune
- NH guam
- NH okinawa
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what are the three functions of the ASWBPLs?
- contingency warehouse
- confirm blood groups and types, labels
- ship blood products to unified commands
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how many units of blood do the ASWBPLs ship to unified commands per day?
7200
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what branch of service operates the blood transshipment centers (BTCs)
USAF
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how many units do the BTCs store/ship per day?
7200
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what are the three functions of the BTCs?
- contral receiving point
- inspect blood, re-ice blood, store blood
- issue blood to blood supply units
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the mission of this office is to ensure adequate supply of high quality blood and blood products, they maintain rapid expansion capabilities.
Navy Blood Program Office (NBPO)
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this provides coordination/management of all navy BB/BDC assets.
Navy blood program office
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how many frozen type O units of blood can the hospital ships hold?
1000
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who manages blood product depots products?
JBPO
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what are the three functions of the blood product depots?
- receive and store frozen blood
- deglycerolize frozen blood
- distribute frozen and deglycerolized blood
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how much blood can be deglycerolized at the blood product depots?
1 unit/machine/hr (2 machines/tech)
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where are the USPACOM blood product depots located?
- Okinawa, Japan
- Camp Carrol
- Camp humphereys
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where is the USEUCOM blood product depot located?
sigonella, italy
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how many units of blood are stored at USPACOM Blood Product Depots (BPD)?
33,000
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how many units are stored at USEUCOM Blood product Depot (BPD)?
6,000
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how many units of RBCs (<-65oC) are kept in storage freezers?
up to 500 units
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the purpose of the FDA is to enforce regulations to ensure what two things?
- safety and efficacy of biologics
- devices used in making reagents or blood components are safe
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what are the FDA's five administrative and legal sanctions?
- revocation and suspension of license
- warning letters
- seizure
- injunctions
- porsecution and consent decree
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this is the regulation which mandates adherence to current GMP practices, it is the legal arm of FDA.
code of federal regulations (CFR)
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the CFR contains 50 titles ___ pertaining to food and drugs.
21
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what series of the CFR covers drugs?
200
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what series of the CFR covers biologics?
600
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Chapter ___ (200-299) and (600-799) deals with GMP.
1
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the purpose of this is to ensure that blood products are consistently manufactured according to, and controlled by quality standards appropriate for their intended use.
good manufacturing practices (GMPs)
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this sets specific quality control requirements and covers several aspects of blood banking and transfusion services.
GMP
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this is part of the FDA which issues federal licenses for the biologic product and conducts all pre-license and pre-approval inspection of blood establishments.
center for biologics, evaluation, and research (CBER)
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FDA licensing requrements are obtaind for both ____________ and __________.
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this provides proof of adherence to prescribed standards
FDA licensing requirements
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true or false
all navy transfusion centers and BDCs fall under on eFDA license.
true
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where is the FDA license kept?
at NBPO
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the following people shall be promptly notified of any accidents in manufacturing/processing of blood:
- Blood Bank Director
- Navy Blood Program Office
- FDA
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what are six reportable errors (only if productrs are shipped or transfused):
- mislabeling of units
- mistyping of units
- shipping/receipt of improperly labeled units
- test interpretation errors
- units repeatedly reactive to viral marker testing
- units received from donors who are temporarily or permanently deffered
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true or false
the director of the office of compliance (CBER) must be reported to if there is a fatility resulting from blood transfusion.
true
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fatalities resluting from blood transfusion must be reported verbally within ___ hrs.
24
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fatalities resulting from blood transfusion must be written reported within ___ days.
7
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the purpose of the infectious look-back program is to notify persons who may receive blood containing any of what eight diseases?
- HIV 1/2
- HTLV I/II
- confirmed syphilis (FTA-ABS)
- HBsAg
- WNV
- CJD
- HCV
- travel to malaria endemic area
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the purpose of this is to examine past records of donor and notify all recipients of prior donations of the possibility of a transfusion associated disease.
infectious disease look-back program
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if a routine donor is flagged on the infectious disease look-back program recipeints should be notified/tested in what order.
reverse chronological
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how long are infectious disease look-back program records maintained?
permanently
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what are the most cited inspection deficiencies?
recordkeeping violations
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inspections require records as proof of what?
satisfactory performance
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changes on records are identified by ____ and ______ responsible.
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true or false
rubber stamps, brackets, dittos are acceptable on official records
false
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what are five records that are kept indefinately?
- final disposition of each unit or component
- deferral letters
- patient notification letters
- signature/initial logs
- transfusion records
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donor ABO/Rh, blood typing difficulties, and donor adverse reaction records are kept for how long?
five years
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patient ABO/Rh, compatibility testing results, and therapeutic procedure records are kept for how long?
five years
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superseded procedures, manuals and publications are kept for how long?
five years
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storage temperatures, inspection of blood products, component, reagents, equipment QC, staff qualification, training and competency are kept for how long?
five years
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this is the most important document in the blood bank.
standard operating procedure (SOP)
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this is a document which describes procedures and techniques in detail, including technical direction an dgeneral requirements imposed by standards and regulations.
Standard operating procedures (SOP)
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procedures added to SOPs must be marked with what?
effective date added
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procedures removed from SOPs must be retained for at least __ years with date of removal recorded.
five
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____ must be maintained in SOP for blood bank staff to initial and date.
log
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how often are SOPs reviewd by medical director or autorized designee?
annually
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________ must precede implementation of SOP change.
training
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the hospital transfusion comittee is required by what four organisations.
- Joint commision
- FDA
- AABB
- CAP
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this reviews usage of blood products, reports adverse reactions, and disease transmission.
hospital transfusion committee
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this is recommended blood orders based on prior blood use.
maximum surgical blood ordering schedule (MSBOS)
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this minimizes requests for crossmatch and provides guidelines to decrease crossmatch to transfusion ratio.
maximum surgical blood ordering schedule (MSBOS)
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commercial reagests must be licensed by ____.
FDA
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this regent must be monitored during storage and shipping.
antiserum
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these are used to ID warm antibodies.
heat blocks or incubators
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temperature of wells on heat blocks are checked when?
daily
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what are water baths used for?
blood thawing
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when are thermometers checked for accuracy?
- on receipt
- periodically (annual)
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what type of calibrated thermometer is used as standard for accuracy?
NIST
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intermittent ______ manual recording is sufficient for refrigerators and freezers.
daily
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out of range temperatures should be explained in ________.
writing
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interior thermometers for refigerators and freezers are kept in what heat trasferable solution.
diluted glyerol
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the volume of fluid that refigerator/freezer thermometer should be equal to or less than what?
smallest component stored
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placement of thermometers in refigerators/freezers should ensure _____ distribution of cooling.
equal
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what should you do if you cannot correct a discrepancy alarm for refrigerators/freezers.
move units
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this is the lab information system designed to ensure highest quality blood products.
Defense Blood Standard System (DBSS)
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what is the mission of the defense blood standard system?
support the armed services blood program
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this is the system used to track movement of blood from CONUS to theater of operation, record receipt and shipment of blood, and track transfusion.
DBSS
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who are the six DBSS users?
- MTF
- BDC
- Moblie blood donor facilities
- ASWBPL
- blood supply units
- blood transshipment centers
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this crosmatch phase uses anti-human globulin to help detect antibodies, also ID of warm antibodies.
coombs phase
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this crossmatch procedure combines donor cells and patient serum and helps detect cold antibodies.
immediate spin-room temp.
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in this crossmatch phase donor cells and patient serum is placed in heat block. may help identify warm antibodies.
37oC phase
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what are the four landing platform dock/amphibious transport dock ships (LPD), and where are they located?
- USS San Antonio (LPD 17) Norfolk, VA
- USS New Orleans (LPD 18) San Diego, CA
- USS Mesa Verde (LPD 19) Norfolk, VA
- USS Green Bay (LPD 20) San Diego, CA
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what are the three Landing Helicopter Amphibious/Landing Helicopter Assault ships (LHA), and where are they located.
- USS Nassau (LHA 4) Norfolk, VA
- USS Peleiliu (LHA 5) San Diego, CA
- USS America (LHA 6) pending
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what are the eight Landing Helicopter Dock ships (LHD) and where are they located?
- USS Wasp (LHD 1) Norfolk, VA
- USS ESSex (LHD 2) Sasebo, Japan
- USS Kearsarge (LHD 3) Norfolk, VA
- USS Boxer (LHD 4) San Diego, CA
- USS Bataan (LHD 5) Norfolk, VA
- USS Bonhomme Richard (LHD 6) San Diego, CA
- USS Iwo Jima (LHD 7) Norfolk, VA
- USS Makin Island (LHD 8) San Diego, CA
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what are the two United States Naval Ships (hospital ships) and where are thy located?
- USNS Mercy (T-AH 19) San Diego, CA
- USNS Comfort (T-AH 20) Baltimore, MD
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the CRTS and hospital ships have two blood bank freezers that can store _____ units of frozen blood at -85oC for up to 10 years.
1000
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CRTS and hospital ships can process ___ units every 30 minutes for emergency usage.
30
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this is the environment in which the ship or squadron is expected to operate including the military climate.
projected operational environment
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This is a command consisting of the service component commander and all those service forces.
component command
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this is a United States joint military command composed of forces from two or more services. has a broad and continuing mission.
unified command
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All UCCs are considered joint commands and are commanded by what rank?
four star general or admiral
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this is a task force whic includes more than one service, established to work on a single defined task or activity.
joint task force
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what is the expiration for CPDA-1?
35 days
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what is the expiration for AS-1 (AdSol)?
42 day expiration
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this is an informal advisory. It is issued for significant regulatory violations requiring prompt corrective actions.
FDA Warning
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this involves removal of equipment or device from a laboratory or facility.
FDA seizure
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this is a court order requiring a laboratory to stop testing.
FDA injunction
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this is when a company must cease and desist prduction or sale until federal law is complied with.
FDA consent decree
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this is any virus, therapeutic serum, toxin or anti-toxin used to treat or cure disease or injuries of man
Biologic
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these are guidelines that outline the aspects of production that would affect the quality of a products.
GMP: Good Manufacturing Practices
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CBER must be notified of an error within ___ hours.
24
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finding during an FDA inspection that there is significant deviation from regulations is documented on what form?
FDA Form 483
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this looks at processes at the time an error took place. teams make recommendations on changes to the process so that error does not repeat itself.
RCA: Root Cause Analysis
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this looks at processes before errors take place. teams amek recommendations to improve a process before an error takes place.
FMEA: Failure Mode Effects Analysis
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