Blood Band Quality Assurance 8.1

  1. This is the evaluation and monitoring of all aspects of a process or system to identify, correct, and prevent unacceptable results.
    Quality assurance
  2. 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
  3. this QA goal procets donors and patients from harm.
    to have safe blood transfusions
  4. emcompassing all processes inclues what two things?
    • individuals
    • facilities
  5. what does GMP stand for?
    good manufacturing processes
  6. what is the QA paradigm shift?
    from service to manufacturer
  7. this is the QA system which oversees all processes.
    quality assurance program
  8. this QA system includes DBSS, CHCS, and document control.
    information management
  9. what does DBSS stand for?
    defence blood standard system
  10. which QA system includes screening, unit typing, and patient ABO/Rh?
    donor and patient testing
  11. which QA system includes testing prior to transfusion?
    compatibility and type and screen
  12. which QA system includes transfusion?
    blood administration
  13. which QA system includes transfusion reactions?
    investigation of averse effects
  14. what QA system includes review proper documentation of transfusion.
    Review and Labeling
  15. this is used to freeze blood
  16. what does CPDA stand for?
    Citrate Phosphate Dextrose Adenine
  17. which QA system includes frozen blood, CPDA, AdSol expiration dates?
    storage and distribution
  18. what does FFP stand for?
    Fresh frozen plasma
  19. which QA system includes testing, typing, and labeling of units?
    component processing
  20. which QA system includes donor screening, and donor preparation?
    blood collection
  21. which QA system includes patients who need phlebotomy for conditons such as polycythemia rubrivera?
    therapeutic phlebotomy
  22. 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
  23. which QA system includes a donor screening process at blood drives?
    allogenic donor suitability
  24. this is the QA system which is the removal of certain components in blood (platelets, plasma) and returning the rest back to the donor?
  25. what year was the armed services blood program office (ASBPO) established?
  26. the ASBPO coordinates blood program of military departments to do what two things?
    • implement standarization
    • coordination during mobilization
  27. what is the ASBP mission?
    • provide blood
    • in the right amounts
    • to the right place
    • at the right time
    • at the right temperature
  28. what is the key to the ASBP mission?
    figuring out how much, where and when
  29. what is the expiration date on liquid RBCs (CPDA-1)?
    35 days
  30. what is the expiration date of liquid RBCs (AS-1 or AS-3)?
    42 days
  31. what is the storage temperature for liquid RBCs?
  32. what is the shipment temperature for liquid RBCs?
  33. what is the licensed expiration for frozen RBCs?
    10 years
  34. what is the contingency expiration for RBCs?
    21 years
  35. what is the storage temperature for frozen RBCs?
  36. what is the shipment temperature for frozen RBCs?
  37. what is the expiration date post thaw, deglycerolization and washing for frozen RBCs?
    14 days
  38. fresh frozen plasma must be processed within how many hours?
  39. what is the expiration for fresh frozen plasma and cryoprecipitate?
    1 year
  40. what is the storage temperature for fresh frozen plasma and cryoprecipitate?
  41. what is the expiration for platelets?
    5 days
  42. what are the storage reqirements for platelets?
    • room temp
    • constant rocking
  43. what temperature should platelets be stored at?
  44. these provide blood to meet military health system needs and continuing ops.
    Blood donor centerss
  45. DoD collects _______ red blood cell units from military, family members, and DoD civilians annually.
  46. where are the two ASWBLs located?
    • Travis AFB
    • McGuire AFB
  47. where are the six BDC's?
    • NMC San Diego
    • NCR ASBBC bethesda
    • NMC portsmouth
    • NH camp lejeune
    • NH guam
    • NH okinawa
  48. what are the three functions of the ASWBPLs?
    • contingency warehouse
    • confirm blood groups and types, labels
    • ship blood products to unified commands
  49. how many units of blood do the ASWBPLs ship to unified commands per day?
  50. what branch of service operates the blood transshipment centers (BTCs)
  51. how many units do the BTCs store/ship per day?
  52. what are the three functions of the BTCs?
    • contral receiving point
    • inspect blood, re-ice blood, store blood
    • issue blood to blood supply units
  53. 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)
  54. this provides coordination/management of all navy BB/BDC assets.
    Navy blood program office
  55. how many frozen type O units of blood can the hospital ships hold?
  56. who manages blood product depots products?
  57. what are the three functions of the blood product depots?
    • receive and store frozen blood
    • deglycerolize frozen blood
    • distribute frozen and deglycerolized blood
  58. how much blood can be deglycerolized at the blood product depots?
    1 unit/machine/hr (2 machines/tech)
  59. where are the USPACOM blood product depots located?
    • Okinawa, Japan
    • Camp Carrol
    • Camp humphereys
  60. where is the USEUCOM blood product depot located?
    sigonella, italy
  61. how many units of blood are stored at USPACOM Blood Product Depots (BPD)?
  62. how many units are stored at USEUCOM Blood product Depot (BPD)?
  63. how many units of RBCs (<-65oC) are kept in storage freezers?
    up to 500 units
  64. 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
  65. what are the FDA's five administrative and legal sanctions?
    • revocation and suspension of license
    • warning letters
    • seizure
    • injunctions
    • porsecution and consent decree
  66. this is the regulation which mandates adherence to current GMP practices, it is the legal arm of FDA.
    code of federal regulations (CFR)
  67. the CFR contains 50 titles ___ pertaining to food and drugs.
  68. what series of the CFR covers drugs?
  69. what series of the CFR covers biologics?
  70. Chapter ___ (200-299) and (600-799) deals with GMP.
  71. 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)
  72. this sets specific quality control requirements and covers several aspects of blood banking and transfusion services.
  73. 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)
  74. FDA licensing requrements are obtaind for both ____________ and __________.
    • establishment
    • product
  75. this provides proof of adherence to prescribed standards
    FDA licensing requirements
  76. true or false
    all navy transfusion centers and BDCs fall under on eFDA license.
  77. where is the FDA license kept?
    at NBPO
  78. the following people shall be promptly notified of any accidents in manufacturing/processing of blood:
    • Blood Bank Director
    • Navy Blood Program Office
    • FDA
  79. 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
  80. true or false
    the director of the office of compliance (CBER) must be reported to if there is a fatility resulting from blood transfusion.
  81. fatalities resluting from blood transfusion must be reported verbally within ___ hrs.
  82. fatalities resulting from blood transfusion must be written reported within ___ days.
  83. 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
  84. 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
  85. if a routine donor is flagged on the infectious disease look-back program recipeints should be notified/tested in what order.
    reverse chronological
  86. how long are infectious disease look-back program records maintained?
  87. what are the most cited inspection deficiencies?
    recordkeeping violations
  88. inspections require records as proof of what?
    satisfactory performance
  89. changes on records are identified by ____ and ______ responsible.
    • date
    • person
  90. true or false
    rubber stamps, brackets, dittos are acceptable on official records
  91. 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
  92. donor ABO/Rh, blood typing difficulties, and donor adverse reaction records are kept for how long?
    five years
  93. patient ABO/Rh, compatibility testing results, and therapeutic procedure records are kept for how long?
    five years
  94. superseded procedures, manuals and publications are kept for how long?
    five years
  95. storage temperatures, inspection of blood products, component, reagents, equipment QC, staff qualification, training and competency are kept for how long?
    five years
  96. this is the most important document in the blood bank.
    standard operating procedure (SOP)
  97. 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)
  98. procedures added to SOPs must be marked with what?
    effective date added
  99. procedures removed from SOPs must be retained for at least __ years with date of removal recorded.
  100. ____ must be maintained in SOP for blood bank staff to initial and date.
  101. how often are SOPs reviewd by medical director or autorized designee?
  102. ________ must precede implementation of SOP change.
  103. the hospital transfusion comittee is required by what four organisations.
    • Joint commision
    • FDA
    • AABB
    • CAP
  104. this reviews usage of blood products, reports adverse reactions, and disease transmission.
    hospital transfusion committee
  105. this is recommended blood orders based on prior blood use.
    maximum surgical blood ordering schedule (MSBOS)
  106. this minimizes requests for crossmatch and provides guidelines to decrease crossmatch to transfusion ratio.
    maximum surgical blood ordering schedule (MSBOS)
  107. commercial reagests must be licensed by ____.
  108. this regent must be monitored during storage and shipping.
  109. these are used to ID warm antibodies.
    heat blocks or incubators
  110. temperature of wells on heat blocks are checked when?
  111. what are water baths used for?
    blood thawing
  112. when are thermometers checked for accuracy?
    • on receipt
    • periodically (annual)
  113. what type of calibrated thermometer is used as standard for accuracy?
  114. intermittent ______ manual recording is sufficient for refrigerators and freezers.
  115. out of range temperatures should be explained in ________.
  116. interior thermometers for refigerators and freezers are kept in what heat trasferable solution.
    diluted glyerol
  117. the volume of fluid that refigerator/freezer thermometer should be equal to or less than what?
    smallest component stored
  118. placement of thermometers in refigerators/freezers should ensure _____ distribution of cooling.
  119. what should you do if you cannot correct a discrepancy alarm for refrigerators/freezers.
    move units
  120. this is the lab information system designed to ensure highest quality blood products.
    Defense Blood Standard System (DBSS)
  121. what is the mission of the defense blood standard system?
    support the armed services blood program
  122. 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.
  123. who are the six DBSS users?
    • MTF
    • BDC
    • Moblie blood donor facilities
    • ASWBPL
    • blood supply units
    • blood transshipment centers
  124. this crosmatch phase uses anti-human globulin to help detect antibodies, also ID of warm antibodies.
    coombs phase
  125. this crossmatch procedure combines donor cells and patient serum and helps detect cold antibodies.
    immediate spin-room temp.
  126. in this crossmatch phase donor cells and patient serum is placed in heat block. may help identify warm antibodies.
    37oC phase
  127. 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
  128. 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
  129. 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
  130. 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
  131. the CRTS and hospital ships have two blood bank freezers that can store _____ units of frozen blood at -85oC for up to 10 years.
  132. CRTS and hospital ships can process ___ units every 30 minutes for emergency usage.
  133. this is the environment in which the ship or squadron is expected to operate including the military climate.
    projected operational environment
  134. This is a command consisting of the service component commander and all those service forces.
    component command
  135. this is a United States joint military command composed of forces from two or more services. has a broad and continuing mission.
    unified command
  136. All UCCs are considered joint commands and are commanded by what rank?
    four star general or admiral
  137. this is a task force whic includes more than one service, established to work on a single defined task or activity.
    joint task force
  138. what is the expiration for CPDA-1?
    35 days
  139. what is the expiration for AS-1 (AdSol)?
    42 day expiration
  140. this is an informal advisory. It is issued for significant regulatory violations requiring prompt corrective actions.
    FDA Warning
  141. this involves removal of equipment or device from a laboratory or facility.
    FDA seizure
  142. this is a court order requiring a laboratory to stop testing.
    FDA injunction
  143. this is when a company must cease and desist prduction or sale until federal law is complied with.
    FDA consent decree
  144. this is any virus, therapeutic serum, toxin or anti-toxin used to treat or cure disease or injuries of man
  145. these are guidelines that outline the aspects of production that would affect the quality of a products.
    GMP: Good Manufacturing Practices
  146. CBER must be notified of an error within ___ hours.
  147. finding during an FDA inspection that there is significant deviation from regulations is documented on what form?
    FDA Form 483
  148. 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
  149. 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
Card Set
Blood Band Quality Assurance 8.1
Unit 8.1 Blood Bank Quality Assurance