Blood Band Quality Assurance 8.1

This is the evaluation and monitoring of all aspects of a process or system to identify, correct, and prevent unacceptable results.

What are the seven goals of quality assurance?

this QA goal procets donors and patients from harm.

emcompassing all processes inclues what two things?

what does GMP stand for?

what is the QA paradigm shift?

this is the QA system which oversees all processes.

this QA system includes DBSS, CHCS, and document control.

what does DBSS stand for?

which QA system includes screening, unit typing, and patient ABO/Rh?

which QA system includes testing prior to transfusion?

which QA system includes transfusion?

which QA system includes transfusion reactions?

what QA system includes review proper documentation of transfusion.

this is used to freeze blood

what does CPDA stand for?

which QA system includes frozen blood, CPDA, AdSol expiration dates?

what does FFP stand for?

which QA system includes testing, typing, and labeling of units?

which QA system includes donor screening, and donor preparation?

which QA system includes patients who need phlebotomy for conditons such as polycythemia rubrivera?

which QA system has a less stringent blood testing system and is made for patients who are donating blood to be used on themselves?

which QA system includes a donor screening process at blood drives?

this is the QA system which is the removal of certain components in blood (platelets, plasma) and returning the rest back to the donor?

what year was the armed services blood program office (ASBPO) established?

the ASBPO coordinates blood program of military departments to do what two things?

what is the ASBP mission?

what is the key to the ASBP mission?

what is the expiration date on liquid RBCs (CPDA-1)?

what is the expiration date of liquid RBCs (AS-1 or AS-3)?

what is the storage temperature for liquid RBCs?

what is the shipment temperature for liquid RBCs?

what is the licensed expiration for frozen RBCs?

what is the contingency expiration for RBCs?

what is the storage temperature for frozen RBCs?

what is the shipment temperature for frozen RBCs?

what is the expiration date post thaw, deglycerolization and washing for frozen RBCs?

fresh frozen plasma must be processed within how many hours?

what is the expiration for fresh frozen plasma and cryoprecipitate?

what is the storage temperature for fresh frozen plasma and cryoprecipitate?

what is the expiration for platelets?

what are the storage reqirements for platelets?

what temperature should platelets be stored at?

these provide blood to meet military health system needs and continuing ops.

DoD collects _______ red blood cell units from military, family members, and DoD civilians annually.

where are the two ASWBLs located?

where are the six BDC's?

what are the three functions of the ASWBPLs?

how many units of blood do the ASWBPLs ship to unified commands per day?

what branch of service operates the blood transshipment centers (BTCs)

how many units do the BTCs store/ship per day?

what are the three functions of the BTCs?

the mission of this office is to ensure adequate supply of high quality blood and blood products, they maintain rapid expansion capabilities.

this provides coordination/management of all navy BB/BDC assets.

how many frozen type O units of blood can the hospital ships hold?

who manages blood product depots products?

what are the three functions of the blood product depots?

how much blood can be deglycerolized at the blood product depots?

where are the USPACOM blood product depots located?

where is the USEUCOM blood product depot located?

how many units of blood are stored at USPACOM Blood Product Depots (BPD)?

how many units are stored at USEUCOM Blood product Depot (BPD)?

how many units of RBCs (<-65^oC) are kept in storage freezers?

the purpose of the FDA is to enforce regulations to ensure what two things?

what are the FDA's five administrative and legal sanctions?

this is the regulation which mandates adherence to current GMP practices, it is the legal arm of FDA.

the CFR contains 50 titles ___ pertaining to food and drugs.

what series of the CFR covers drugs?

what series of the CFR covers biologics?

Chapter ___ (200-299) and (600-799) deals with GMP.

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.

this sets specific quality control requirements and covers several aspects of blood banking and transfusion services.

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.

FDA licensing requrements are obtaind for both ____________ and __________.

this provides proof of adherence to prescribed standards

true or false
all navy transfusion centers and BDCs fall under on eFDA license.
True False

where is the FDA license kept?

the following people shall be promptly notified of any accidents in manufacturing/processing of blood:

what are six reportable errors (only if productrs are shipped or transfused):

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 False

fatalities resluting from blood transfusion must be reported verbally within ___ hrs.

fatalities resulting from blood transfusion must be written reported within ___ days.

the purpose of the infectious look-back program is to notify persons who may receive blood containing any of what eight diseases?

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.

if a routine donor is flagged on the infectious disease look-back program recipeints should be notified/tested in what order.

how long are infectious disease look-back program records maintained?

what are the most cited inspection deficiencies?

inspections require records as proof of what?

changes on records are identified by ____ and ______ responsible.

true or false
rubber stamps, brackets, dittos are acceptable on official records
True False

what are five records that are kept indefinately?

donor ABO/Rh, blood typing difficulties, and donor adverse reaction records are kept for how long?

patient ABO/Rh, compatibility testing results, and therapeutic procedure records are kept for how long?

superseded procedures, manuals and publications are kept for how long?

storage temperatures, inspection of blood products, component, reagents, equipment QC, staff qualification, training and competency are kept for how long?

this is the most important document in the blood bank.

this is a document which describes procedures and techniques in detail, including technical direction an dgeneral requirements imposed by standards and regulations.

procedures added to SOPs must be marked with what?

procedures removed from SOPs must be retained for at least __ years with date of removal recorded.

____ must be maintained in SOP for blood bank staff to initial and date.

how often are SOPs reviewd by medical director or autorized designee?

________ must precede implementation of SOP change.

the hospital transfusion comittee is required by what four organisations.

this reviews usage of blood products, reports adverse reactions, and disease transmission.

this is recommended blood orders based on prior blood use.

this minimizes requests for crossmatch and provides guidelines to decrease crossmatch to transfusion ratio.

commercial reagests must be licensed by ____.

this regent must be monitored during storage and shipping.

these are used to ID warm antibodies.

temperature of wells on heat blocks are checked when?

what are water baths used for?

when are thermometers checked for accuracy?

what type of calibrated thermometer is used as standard for accuracy?

intermittent ______ manual recording is sufficient for refrigerators and freezers.

out of range temperatures should be explained in ________.

interior thermometers for refigerators and freezers are kept in what heat trasferable solution.

the volume of fluid that refigerator/freezer thermometer should be equal to or less than what?

placement of thermometers in refigerators/freezers should ensure _____ distribution of cooling.

what should you do if you cannot correct a discrepancy alarm for refrigerators/freezers.

this is the lab information system designed to ensure highest quality blood products.

what is the mission of the defense blood standard system?

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.

who are the six DBSS users?

this crosmatch phase uses anti-human globulin to help detect antibodies, also ID of warm antibodies.

this crossmatch procedure combines donor cells and patient serum and helps detect cold antibodies.

in this crossmatch phase donor cells and patient serum is placed in heat block. may help identify warm antibodies.

what are the four landing platform dock/amphibious transport dock ships (LPD), and where are they located?

what are the three Landing Helicopter Amphibious/Landing Helicopter Assault ships (LHA), and where are they located.

what are the eight Landing Helicopter Dock ships (LHD) and where are they located?

what are the two United States Naval Ships (hospital ships) and where are thy located?

the CRTS and hospital ships have two blood bank freezers that can store _____ units of frozen blood at -85^oC for up to 10 years.

CRTS and hospital ships can process ___ units every 30 minutes for emergency usage.

this is the environment in which the ship or squadron is expected to operate including the military climate.

This is a command consisting of the service component commander and all those service forces.

this is a United States joint military command composed of forces from two or more services. has a broad and continuing mission.

All UCCs are considered joint commands and are commanded by what rank?

this is a task force whic includes more than one service, established to work on a single defined task or activity.

what is the expiration for CPDA-1?

what is the expiration for AS-1 (AdSol)?

this is an informal advisory. It is issued for significant regulatory violations requiring prompt corrective actions.

this involves removal of equipment or device from a laboratory or facility.

this is a court order requiring a laboratory to stop testing.

this is when a company must cease and desist prduction or sale until federal law is complied with.

this is any virus, therapeutic serum, toxin or anti-toxin used to treat or cure disease or injuries of man

these are guidelines that outline the aspects of production that would affect the quality of a products.

CBER must be notified of an error within ___ hours.

finding during an FDA inspection that there is significant deviation from regulations is documented on what form?

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.

this looks at processes before errors take place. teams amek recommendations to improve a process before an error takes place.