Exam Solution Manual for Blood Banking Laws and Blood Bank Quality Management Graded A+
Republic Act 1517 - Answers Blood Banking Law of 1956
June 16, 1956
Purpose of safeguarding and promoting public health and welfare by preventing unproper collection,
processing and sale of human blood or its product to the public
Republic Act 7719 - Answers National Blood Services Act of 1994
May 5, 1994
AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR AN ADEQUATE SUPPLY OF SAFE
BLOOD, REGULATING BLOOD BANKS, AND PROVIDING PENALTIES FOR VIOLATION THEREOF
Classification of Blood Service Facility - Answers -Ownership
-Institutional Character
-Service Capability
Ownership - Answers • Government
• Private (hospital-based blood service facility)
Institutional Character - Answers • Hospital-based
• Non-hospital-based (Government owned or PNRC-owned)
Service Capability - Answers - BLOOD STATION (BS)
- BLOOD COLLECTION UNIT (BCU)
- BCU/BS
- BLOOD BANK (BB)
- BLOOD CENTER (BC)
Blood banks must provide quality to their customers in many forms, including: - Answers • Safe,
satisfying donation experiences for blood donors.
• Accurately labeled and tested blood components provided to transfusion services.
• Timely, accurate transfusion services provided to physicians and other health-care personnel.
• Safe and efficacious blood transfusions to patients.
, The method for bringing this quality philosophy into all operations involves each facility developing a
foundation of quality: - Answers ❑Quality control (QC)
❑Quality assurance (QA)
❑Quality management system (QMS)
Blood bank compliance with federal regulations and accreditation standards is required by the following
organizations: - Answers ❑ United States Food and Drug Administration (FDA)
❑ The Joint Commission
❑ College of American Pathologists (CAP) ❑ Association for the Advancement of Blood & Biotherapies
(AABB)
Compliance program - Answers evaluate how effectively the facility meets regulatory and accreditation a
requirements by detecting errors, deficiencies, and deviations
Compliance inspections - Answers measure the state of the facility's program with respect to the
applicable requirements and are usually conducted every 2 years
Quality management (QM) - Answers is actively and continuously practiced by blood bank leaders,
managers, and staff throughout all blood bank operations.
QUALITY CONTROL PROCEDURES - Answers ✓Daily testing the reactivity of blood typing reagents.
✓Calibrating serologic centrifuges;
✓Timer checks
✓Monitoring temperatures
✓Manufacturers' package inserts,
✓Regular performance of QC
Quality System - Answers Organizational structure, procedures, processes, and resources needed to
implement quality management
Quality Assurance - Answers Planned and systematic activities implemented within the quality system to
provide confidence that requirements for quality will be fulfilled
Quality Control - Answers Operational techniques and activities used to fulfill the requirements for
quality
Individualized Quality Control Plan (IQCP) - Answers ❑Laboratory's Risk Assessment.
❑Pre-analytic, Analytic, and Post-Analytic Processes
Republic Act 1517 - Answers Blood Banking Law of 1956
June 16, 1956
Purpose of safeguarding and promoting public health and welfare by preventing unproper collection,
processing and sale of human blood or its product to the public
Republic Act 7719 - Answers National Blood Services Act of 1994
May 5, 1994
AN ACT PROMOTING VOLUNTARY BLOOD DONATION, PROVIDING FOR AN ADEQUATE SUPPLY OF SAFE
BLOOD, REGULATING BLOOD BANKS, AND PROVIDING PENALTIES FOR VIOLATION THEREOF
Classification of Blood Service Facility - Answers -Ownership
-Institutional Character
-Service Capability
Ownership - Answers • Government
• Private (hospital-based blood service facility)
Institutional Character - Answers • Hospital-based
• Non-hospital-based (Government owned or PNRC-owned)
Service Capability - Answers - BLOOD STATION (BS)
- BLOOD COLLECTION UNIT (BCU)
- BCU/BS
- BLOOD BANK (BB)
- BLOOD CENTER (BC)
Blood banks must provide quality to their customers in many forms, including: - Answers • Safe,
satisfying donation experiences for blood donors.
• Accurately labeled and tested blood components provided to transfusion services.
• Timely, accurate transfusion services provided to physicians and other health-care personnel.
• Safe and efficacious blood transfusions to patients.
, The method for bringing this quality philosophy into all operations involves each facility developing a
foundation of quality: - Answers ❑Quality control (QC)
❑Quality assurance (QA)
❑Quality management system (QMS)
Blood bank compliance with federal regulations and accreditation standards is required by the following
organizations: - Answers ❑ United States Food and Drug Administration (FDA)
❑ The Joint Commission
❑ College of American Pathologists (CAP) ❑ Association for the Advancement of Blood & Biotherapies
(AABB)
Compliance program - Answers evaluate how effectively the facility meets regulatory and accreditation a
requirements by detecting errors, deficiencies, and deviations
Compliance inspections - Answers measure the state of the facility's program with respect to the
applicable requirements and are usually conducted every 2 years
Quality management (QM) - Answers is actively and continuously practiced by blood bank leaders,
managers, and staff throughout all blood bank operations.
QUALITY CONTROL PROCEDURES - Answers ✓Daily testing the reactivity of blood typing reagents.
✓Calibrating serologic centrifuges;
✓Timer checks
✓Monitoring temperatures
✓Manufacturers' package inserts,
✓Regular performance of QC
Quality System - Answers Organizational structure, procedures, processes, and resources needed to
implement quality management
Quality Assurance - Answers Planned and systematic activities implemented within the quality system to
provide confidence that requirements for quality will be fulfilled
Quality Control - Answers Operational techniques and activities used to fulfill the requirements for
quality
Individualized Quality Control Plan (IQCP) - Answers ❑Laboratory's Risk Assessment.
❑Pre-analytic, Analytic, and Post-Analytic Processes
