MMSC 409 Final Exam Graded

MMSC 409 Final Exam Graded A+;Actual test Identify the organizations and their role in transfusion medicine, including FDA, CBER,

AABB, Joint Commission. Answer- 1. FDA = Food and Drug Administration: CFR,

CBER, & licensing (a) Code of Federal Regulations (CFR) - blood is a biologic & a drug

(b) Center for Biologics Evaluation and Research (CBER) regulates:

-blood/component collection -pharmaceuticals manufactured from blood/components (c) Licenses blood collection centers & all aspects (reagents, processes, inspections)

• AABB: international association of blood centers, transplantation services, individuals

(a) Voluntary inspection/accreditation of member institution laboratories (b) Standards to meet CLI'88 and CMS requirements

• Joint Commission: voluntary inspection/accreditation of member institutions (whole

hospital or specific units) Identify/interpret oxygen-hemoglobin dissociation curve and causes for right and left shifts. Answer- Oxyhemoglobin (in % saturation) on y-axis, is plotted against PO₂ (mmHg) on x-axis

left shift can be caused by:

↑ - p(CO) & pH (alkalosis) ↓ - temp, DPG, p(CO₂) type of Hgb - fetal

right shift can be caused by:

↑ - temp, DPG, p(CO₂) ↓ - p(CO) & pH (acidosis) type of Hgb - adult Determine if a donor would be deferred for results of the "mini-physical." Answer- All of

the following requirements must be met:

• General appearance
• Weight: require 110 lbs. →autologous donation - if less than 100 lbs., must adjust

amount collected/amount of anticoagulant

3. Temperature: <37.5°C (<99.5°F)

4. Pulse: 50-100 bpm 1 / 3

5. Blood pressure:

-Systolic ≤180 mm Hg -Diastolic ≤100 mm Hg

6. Hemoglobin/hematocrit (Hgb/Hct):

-Hgb ≥12.5 g/dL (females) & ≥13.0 g/dL (males)

7. Arm check: for skin lesions & drug abuse

• Permanent deferral file

Determine if a donor would be deferred for their donation history. Answer- FDA recommended process for screening blood donors is the Uniform Donor History and ID

Verification (UDHQ):

-Process consists of (1) Uniform Donor History Questionnaire (UDHQ)

-obtain general information: demographics, name, address/phone number, DOB,

gender, etc.→if directed donor, credit information for Blood Deductible/Insurance (Blood Bank of Delmarva) -obtain other info: donor consent, date of last donation, last meal, prior results, etc.(2) A request for identification -possibly SS# or Driver's License # (3) An informational handout (required by FDA) -Provide donor with educational materials Determine if a donor would be deferred for their infectious disease testing results.

Answer- 1. Deferral, permanent: Confirmed HBsAg+ test

2. Deferral, indefinite to permanent:

-Positive serologic test results or clinical past/present evidence suggestive of infection

from any types of the following pathogens/diseases:

(a) HIV (b) Hepatitis C or B (c) Human T Lymphotropic Virus (HTLV) (d) T. cruzi (Chagas disease) (e) Syphilis (f) West Nile Virus (g) ALT (alanine aminotransferase) - optional →any positive test must be repeated

Differentiate among allogeneic and autologous donation, including:

• Definition

2. Testing required Answer- -Allogenic:

• Definition - donation for "shelf blood"

→"Homologous"

• Testing required - per AABB & FDA, donor processing includes ABO/Rh typing,

ABSC, & Infectious disease testing

-Autologous: 2 / 3

• Definition - donation of unit of blood for one's self
• Testing required -

→ABO & Rh₀(D) testing →To be transfused outside collection facility: 1st unit must be tested for HBsAg, Anti- HBc, Anti-HCV, HCV RNA, Anti-HIV1/2, HIV-1-RNA, STS (30 days) →Any tests reactive = biohazard label

Define the following characteristics as they apply to directed donation:

• Definition
• Testing required
• Special considerations Answer- 1. Definition - recipient "chooses" donor
• Testing required -same testing as for homologous blood donation
• Special considerations - irradiation (kills lymphocytes) required for 1st & 2nd degree

relatives →prevents transfusion-associated graft vs host disease (TA-GVHD)

Define the following characteristics as they apply to pheresis donation:

• Definition
• Testing required
• Special considerations Answer- 1. Definition - removal of whole blood (WB) from

donor or patient, separate into components, keep desired component, & return remaining elements back to donor or patient →dependent on different densities of blood constituents

• Testing required - performed on blood product post pheresis donation

→ABO, Rh, antibody screen, infectious disease testing →RBC < 5 mL →Platelet count →WBC count →Every 4 months Serum protein electrophoresis

• Special considerations - specific pheresis donor criteria

(a) Medications -aspirin-free for 3 days -Plavix/Ticlid - 14 day deferral (b) Platelet count > 150,000 uL (plateletpheresis and leukapheresis) (c) WBC with differential > 4,000 uL (leukapheresis) (d) Serum protein > 6.0 g/dL

(e) Double Red Cell Pheresis:

-males - 130 lbs., 5'1" tall (min.) -females - 150 lbs., 5'5" tall (min.) -Hematocrit > 40% Match the blood product/component with targeted therapy (e.g. anemia, coagulation

issues, ...). Answer- 1. Autologous donations:

• When collected pre-operatively, can be used for patients w/ an elective surgery who

have a very rare blood type (have Ab to high-freq RBC Ag)

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