Exam D Study Guide Flashcards
1
Q
True or false:
A unit of blood must be labeled to identify it as being from a person who donated blood as a volunteer or was paid for their blood.
A
True
2
Q
Only blood centers licensed by the ___________ Administration can routinely ship blood across state lines.
A
Food and Drug
-Blood centers must follow the regulations in the Code of Federal Regulations (CR) parts 211 and 600-799.
3
Q
What does AABB stand for?
A
Association for the Advancement of Blood & Biotherapies.
-Formerly called the American Association of Blood Banks.
4
Q
Standards are __________ followed by transfusion services and blood centers that choose to be accredited by the AABB
A
voluntarily
-Following the AABB Standards is considered the standard of care for blood centers and is followed by most facilities.
5
Q
AABB standards are updated every ___ years.
A
two
6
Q
Regulate plasma fractionation companies in Europe.
A
European Union (EU) Standards
-– Blood centers that supply plasma or other blood components for further manufacturing to these facilities must comply with EU standards.
– EU standards are published as the Directive of the European Parliament and of the Council.
7
Q
Most blood centers require the identification to contain the donor’s…
A
full name and some other identifying information such as a date of birth or a photograph.
-During registration process demographic information is obtained from the donor.
8
Q
In most states, donors who are at least ___ years of age can donate without parental consent.
A
17
-in many states, 16-year-olds may donate if they have parental consent
9
Q
What is the name of the list of donors that are deferred?
A
donor deferral registry (DDR) or deferred donor directory (DDD).
10
Q
Educating the Donor:
Educational materials can be obtained through the ____ and _____ website and cannot be changed with regard to order, content, and writing.
A
FDA, AABB
11
Q
The AABB developed the Donor History Questionnaire (DHQ). The DHQ has been approved by the _____.
A
FDA
12
Q
What does DHQ stand for?
A
Donor History Questionnaire
13
Q
The DHQ was developed to ensure that the donor
A
gets a consistent message and that questions asked are thorough and meed AABB standards and FDA regulations.
14
Q
Deferrals fall within what three categories?
A
-Temporary deferral
-Permanent deferral
-Indefinite deferral
15
Q
Means the prospective donor is unable to give blood to someone else for an unspecified period of time due to current regulatory requirements.
A
Indefinite deferral
16
Q
The donor’s vital signs must be taken and a hemoglobin or _________ must be performed.
A
hematocrit
17
Q
AABB Standards for vital signs:
-Temperature must be less than or equal to __________.
A
99.5° F (37.5° C)
18
Q
AABB Standards for vital signs:
Blood pressure must have a systolic pressure less than or equal to ____ mm Hg and a diastolic pressure no higher than ______ mm Hg.
A
180, 100
19
Q
AABB Standards for vital signs:
-Pulse should be taken for at least 15 seconds and be ________ beats per minute. If the donor is athletic, a pulse less than ___ beats per minute may be acceptable. The pulse should also be regular. If the pulse is irregular, further questioning of the donor must be done to attempt to determine the reason for the irregular pulse.
A
50–100
50
20
Q
For whole blood donations, a hemoglobin check can be performed using ________ sulfate solution with a specific gravity of _______.
A
copper, 1.053
21
Q
The minimum hemoglobin level for an allogeneic whole blood donation is ___________).
A
12.5 g/dL (125 g/L)
22
Q
For automated double RBC donations, the hemoglobin must be at least __________.
A
13.3 g/dL (133 g/L)
23
Q
If the copper sulfate hemoglobin screening test fails, a hematocrit may be performed on a ________ blood specimen.
Hct. must be at least ____ for allogeneic donations.
Automated double RBC ______
automated single RBC collections ______.
A
capillary
38%
40%
33%
24
Q
Hct. performed by copper sulfate:
For autologous donations, the hemoglobin must be at least ____ g/dL or the hematocrit must be at least ____% (0.33).
A
11
33
25
What does CUE stand for?
Confidential Unit Exclusion
26
Provides a confidential way in which donors can indicate that their blood should not be used for transfusion
Confidential Unit Exclusion (CUE)
27
The CUE can be accomplished by what two methods?
Give the donor a card with two barcode labels. One label is identified as a “yes” label and indicates that the donor feels it is safe to use his or her blood. The other label is identified as “no” and indicates the donor believes he or she is not a suitable donor. The donor selects the label and puts it on the health history form. The barcode is scanned after the donation process. Donations from “no” are discarded.
Give the donor instructions to call the blood center after the donation and ask that the blood collected not be used. A card with the donation number and a telephone number to call is given to the donor.
28
What is the maximum volume of blood that may be collected?
10.5 mL/kg of body weight
29
For a donor who is the minimum weight of 110 pounds or 50 mg, the maximum whole blood that should be collected according to current regulations is ____ mL including the lab samples.
525
30
The blood collection sets must be approved by the ____ and must be sterile and free from any extraneous material.
FDA
31
Whole blood is not frequently utilized as such in the United States. Therefore, one of the satellite bags of most collection sets contains an additive solution (AS) to extend the shelf life of the red blood cell component to ____ days, twice the length of units without the additive solution.
42
32
Another anticoagulant/preservative in the main collection bag of some blood collection sets is citrate phosphate dextrose adenine (CPDA-1). The adenine (used for making ATP) is a nutrient in the solution that has been FDA approved for storing whole blood or RBC for _____ days.
35
33
A large-bore needle, often a ____-gauge needle, is attached to the collection set. The needle size must be large enough to prevent hemolysis of the RBC and to allow the blood to flow fast enough to prevent the clotting process to start before the blood reaches the anticoagulant in the collection bag.
16
34
A unique identification number must be placed on what three things?
This number is a confidential way of tracking the donated blood from collection through the actual transfusion to the recipient.
the DHQ, the blood collection bag, and the tubes used for donor testing
35
Blood centers accredited by the AABB use an international donor identification numbering system called ________.
ISBT 128
36
Most blood collection sets have a sample diversion pouch on one side of a Y connector, which allows the first _______ mLs of blood collected to be diverted into the pouch.
Once a sufficient amount of blood is collected in the diversion pouch, the pouch is sealed off and the blood is allowed to flow into the tubing on the other side of the Y connector and into the blood bag.
20–40
37
What is the blood used for that is collected in the diversion pouch?
donation specimen testing.
-The specimen tubes must be labeled with the same unique donor identification number that was placed on the blood bag. The FDA requires that the number must be placed on the tubes prior to filling them.
38
Most whole blood donations are completed within 5–10 minutes. What is the risk If the donation takes too long?
coagulation may begin.
-If a clot forms, the collection process is discontinued and the partial donation is referred to as quantity not sufficient (QNS). These units cannot be used for transfusion.
39
When a phlebotomy is discontinued before the entire amount of blood is collected (300–400 mL of whole blood for the 450 +/– 45 mL collection set or 333–449 mL of whole blood for the 500 +/– 50 mL bag) and no clot is present, the red blood cells prepared from this unit are labeled “______________.” No other components may be made from a low-volume collection.
Red Blood Cells Low Volume
40
The amount of blood collected at each whole blood donation cannot exceed _____ mL per kilogram of donor weight.
10.5
41
The donor is asked to hold a piece of gauze applying pressure over the venipuncture site. The arm should be ___________ to help prevent a hematoma from forming.
held straight (not bent)
42
After collection the unit of whole blood is placed in a container that will cool the blood down to between _____ F and _____________, unless platelets are to be produced from the blood. If platelets are to be manufactured, the blood should be placed in a container that will cool the blood down to _________________.
33.8°, 50° F (1° C and 10° C)
68–75.2° F (20–24° C).
43
When collecting blood components by automation, the AABB Standards say to follow the instrument operator’s manual when collecting these donors; however:
-The collection shall not exceed a volume predicted to result in a donor hematocrit of less than ____% or a hemoglobin value of less than _______ after volume replacement.
-During the donation, saline is given to the donor to replace some of the blood volume removed.
30,
10 g/dL (100 g/L)
44
Donors must wait ___ weeks to donate again after donating a double RBC.
16
45
Sometimes one unit of RBCs and the equivalent of two units of fresh frozen plasma are collected. The donor criteria for this type of donation are the same as for whole blood donations, which is...
-Saline is given to the donor to replace some of the additional blood volume removed as compared to a whole blood donation.
-Donors are deferred from donating for 8 weeks because only one unit of RBC is collected during this type of donation.
46
A single unit or approximately 200 mLs of RBC can be donated once every ____ weeks.
8
47
Plasmapheresis:
1. Plasma collected by automation.
2. May be donated once every ___ weeks
4
48
A maximum volume of ____ mL of plasma, excluding the amount of anticoagulant, can be collected from donors weighing 175 pounds or less at each donation.
500
49
Plasmapheresis:
The total volume collected from a donor must not exceed ___ liters within a rolling 12-month timeframe.
12
50
Plasmapheresis:
For donors weighing more than 175 pounds (79 kg), a maximum volume of _____ mL of plasma can be collected at each donation, not to exceed _____ liters within a rolling 12 months.
600
14.4
51
Enough platelets can be removed from a single donor to produce a therapeutic dose for a patient.
What is the benefit of this for the recipient?
therapeutic dose without exposure to multiple donors
-With technological advances, two or more therapeutic doses of platelets can sometimes be collected from one donor with a single procedure.
-The platelet count on the apheresis product must be sufficiently high to be able to split the product into a double dose or sometimes a triple dose of platelets.
52
The donor requirements for donating platelets by automation are...
the same as for whole blood, with an additional requirement of a platelet count of at least 150,000 /µL (150 X109/L).
53
Plateletpheresis:
Aspirin and piroxicam (Feldane) must be stopped for ___ hours prior to collection and the donor must be off of antiplatelet drugs such as clopidogrel (Plavix) for ___ weeks.
48, 2
54
When is a platelet count not required for plateletpheresis?
prior to the first donation or if there have been more than 4 weeks since the last donation.
55
Donors are eligible to donate a single plateletpheresis unit every ____ hours, not to exceed ___ donations in 7 days.
48, two
56
The interval between a double or triple plateletpheresis donation should be at least ___ days.
7
57
A maximum of _____ platelet donations can be made in a rolling 12-month period.
24
58
The FDA requires that the amount of ______ and ______ lost during each plateletpheresis procedure be recorded and the cumulative loss tracked over time.
plasma, RBC
-The requirements for plasma loss include the amount of plasma collected during platelet collections.
-The RBC loss includes the residual whole blood remaining in the collection set at the end of the procedure, whole blood in the sample tubes collected for laboratory testing, and any concurrent RBC collected in addition to the platelets.
59
The accumulated laboratory data for plateletpheresis donors must be monitored by qualified staff and donor platelet counts less than ____________ must be reported to the medical director.
100,000/µL ( 100 X109/L)
60
If there are visibly apparent RBCs in the platelet component, a hematocrit is then performed on the component.
-If more than ___ mL of RBCs are present in the platelet component, a blood sample from the donor must be attached for compatibility testing with the potential recipient
2
61
When 1 unit of RBCs is collected, the donor is deferred for 8 weeks.
-If only 1 unit of RBCs is collected, the donor may donate platelets or plasma by apheresis within ___ weeks if the extracorporeal RBC loss during the apheresis collection is less than ____ mL.
8
100
62
Most common type of donor reaction, which can cause the donor to faint.
Vasovagal Reaction
63
Describe a vasovagal reaction.
the body’s response is abnormal. The heart rate does not increase and the blood vessels do not constrict, but instead may dilate. This results in a decrease of blood flow to the brain and sometimes a drop in blood pressure as well. The donor may lose consciousness
64
What could cause a hematoma to form?
(1) puncturing both the proximal and distal sides of a vein, (2) removing needle prior to releasing the tourniquet, or (3) not putting enough pressure on the venipuncture site after the needle has been removed.
65
___________ are caused by fluid going into the interstitial tissue instead of the vein. This happens if a needle is not inserted into the vein far enough and the pressure causes the needle to come further out of the vein.
Infiltrations
66
What does PAD stand for?
preoperative autologous donation
67
When is a autologous donation not permitted?
if the donor has a clinical condition for which there is a risk of bacteremia.
68
Ture or false:
The time between these types of donations can be less than the interval required for allogeneic donations.
True
69
The minimum hematocrit requirement is ___% hemoglobin of 11 g/dL (110 g/L) or greater if hemoglobin is used) for autologous whole blood and ___% for autologous automated double RBCs.
33, 35
70
True or false:
Donations are reserved for the patient’s use but can be placed in regular inventory if not used.
False.
Reserved for the patients use only. cannot be placed in regular inventory.
71
All donations by the patient-donor must be completed more than ___ hours before the time of planned surgery or transfusion.
72
72
Units are labeled “For Autologous Use Only” and are stored in...
a separate location in the refrigerator from the allogeneic units.
73
True or false:
The patient may have a history that would normally exclude him or her from donating allogeneic blood for other patients, but would allow donation for him- or herself.
True
74
Testing of autologous donors beyond ABO and Rh is only required if the blood is...
shipped to another facility and only for the first donation collected during each 30-day period
75
Can directed unit donations be placed in regular inventory if not used by the directed patient?
Blood centers have different policies as to whether these units of blood may be placed in the general blood inventory if they are not used by the patient for whom they were designated or if they were incompatible with the patient. Some blood centers do not allow the crossover to the general blood inventory.
76
Are directed blood donations safer?
Numerous studies determined that directed donations are no safer than blood from the general public.
77
True or false:
Health history questionnaires, donor requirements, and laboratory testing must be the same as for any other allogeneic donation.
True
78
Therapeutic Phlebotomy units are typically not utilized and are discarded.
What is an exception?
a variance from the FDA if they met all the allogeneic criteria and are labeled with the condition for which the donor is being phlebotomized.
79
Infectious disease testing currently required by the FDA on units intended for allogeneic use includes tests for...
Syphilis
Hepatitis B
Hepatitis C
Human T-cell lymphotrophic virus (HTLV)
HIV
West Nile virus (WNV)
80
The required infectious disease testing must use FDA-licensed tests for:
-Antibodies to:
o HIV (anti-HIV 1/2)
o Hepatitis C virus (anti-HCV)
o Human T-cell lymphotrophic virus (anti-HTLV I/II)
o Hepatitis B core antigen (anti-HBc)
Surface antigen for hepatitis B (HBsAg)
Nucleic acid testing (NAT) for HCV ribonucleic acid (RNA)
HIV-1 RNA
WNV RNA
Serologic test for syphilis
81
Other tests, like antibodies to ___________, the causative agent of Chagas’ disease, is licensed by the FDA for screening blood donors and recommended for use.
Trypanosoma cruzi (T. cruzi)
82
Ture or false:
Hepatitis B virus nucleic acid testing (NAT) for DNA (HBV NAT) is FDA-licensed and also performed at most blood centers.
true
83
Blood samples with a positive antibody screen are tested further for antibody identification. The identification of the antibody must be recorded on the final label of the blood component unless the final RBC component is one that has had all of the ________ removed.
plasma
84
Ture or false:
Many blood centers use RBCs from donors with antibodies as long as the antibody is properly identified for that unit.
false.
Many blood centers do not use RBCs from donors with antibodies and defer them from donation.
85
What is done if an infectious disease screening test comes back positive?
a positive screening test is repeated in duplicate. If two out of three results are positive, it is considered as repeat reactive or positive. A confirmatory test, if available, is performed.
86
Physicians may request cytomegalovirus (CMV)-negative blood components for what patients?
immunocompromised and known to be CMV negative.
87
What is a "Donor Lookback"?
-Performed whenever a repeat donor tests positive for an infectious disease when the donor was previously negative.
-The blood center checks which patient(s) received the blood products from this donor’s previous donation and whether the patient(s) contracted the disease for which the donor now tests positive.
88
What type of anticoagulants are typically used for blood products?
citrate based, binding calcium and blocking the coagulation cascade.
-citrate–phosphate–dextrose (CPD)
-citrate–phosphate–dextrose–dextrose (CP2D)
-acid–citrate–dextrose (ACD)
-citrate–phosphate–dextrose–adenine solution (CPDA-1).
89
The entire collection set is sterile on the inside and the satellite containers allow whole blood to be...
separated into individual blood components in a closed system.
90
On average, whole blood has a volume of _______ mL and a minimum hematocrit of ______ %.
450 or 500
38
91
How are RBC units made?
by centrifuging whole blood in a very large centrifuge that can hold anywhere from 6 to 12 whole blood collection sets.
92
How do the different components separate after centrifugation?
RBCs concentrate at the bottom of the container, followed by white blood cells and platelets, which usually settle on top of the red blood cell layer. The top portion of a centrifuged collection bag contains the liquid plasma portion of whole blood.
93
After centrifugation, the blood unit is placed into a...
plasma press, also called an expresser.
94
What is done after the plasma has been pressed?
the resulting red blood cells and plasma bags can be separated by using a tubing sealer to close off the connection tubing and then detaching the components at the seals.
95
A red blood cell component will generally have a volume of ______ mL and a hematocrit of _______%
225 to 350
(65%) to (80%).
96
If an additive solution is used to prolong shelf life, the final volume of the component will vary from 300 to 400 mL and the hematocrit will be somewhat lower, at ____%
(55–65%)
97
A typical red blood cell unit prepared from whole blood contains _____ grams of hemoglobin
50–80
98
In most cases, plasma is stored frozen. Why?
to preserve the activity of labile plasma proteins. Factors V and VIII
99
Plasma is considered to have ___ unit of each coagulation factor in every 1 mL of fresh frozen plasma (FFP).
1
100
Whole blood–derived plasma components vary in volume but normally range from ______ mL.
200 to 300
101
Fresh frozen plasma can be further processed to produce...
cryoprecipitated antihemophilic factor (AHF) and plasma, cryoprecipitate reduced.
102
When frozen FFP is thawed slowly at 33.8–42.8° F (1–6° C), proteins that are insoluble in the cold will precipitate out. After centrifugation, the majority of the plasma is extracted from the precipitated protein sediments into a satellite container.
-Plasma extraction may be done by _______ or with a ____________.
gravity, plasma press
103
The plasma that is extracted from the precipitate is called...
plasma, cryoprecipitate reduced.
104
what does plasma treated with a solvent/detergent solution do?
inactivates lipid-enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and cytomegalovirus (CMV) by breaking down the lipid envelope.
105
What viruses are not inactivated by the plasma solvent/detergent process?
Viruses without envelops such as hepatitis A virus (HAV) and parvovirus
-must be treated with a second process to inactivate them or detected by nucleic acid testing (NAT)
106
Solvent-/detergent-treated plasma is currently not licensed in the United States or Canada, but is in use in _________.
Europe
107
Instead of preparing transfusable plasma components for direct transfusion to patients, plasma may be sent to manufacturers that can separate out individual proteins, such as albumin or specific coagulation factors, for patient use. Plasma that is intended to be used for this process is called...
recovered plasma or plasma for manufacture.
108
Why are platelet donations maintained at room temperature during all stages of collection, storage, and production?
Platelet function is impaired following storage at colder temperatures
109
What are the two approved methods for extracting platelet components from whole blood donations?
-The platelet-rich plasma (PRP) method produces a single platelet component from a single whole blood donation and is widely used in the United States.
-The buffy coat (B/C) method produces a pool of platelets from 4 to 6 whole blood donations and is the most common method in Europe and Canada.
*Both processes are two-stage, requiring two separate centrifugation and extraction steps to produce the platelet component.
110
What is the first stage for the Platelet-Rich Plasma (PRP)?
The first stage of PRP production is the recovery of PRP from a whole blood donation. This is achieved by centrifuging the whole blood at a low relative centrifugal force (RCF), also known as a “soft spin.”
-The centrifuged whole blood is placed on a plasma press and the PRP is expressed into an empty satellite container
111
second stage of PRP production...
preparation of a platelet concentrate. The PRP is centrifuged at a relatively high RCF, also called a “hard spin,” causing the platelets to concentrate or aggregate into a pellet at the bottom of the bag.
112
A single component of PRP produced from whole blood will contain a minimum of _______ platelets and a total volume of 40–70 mL.
5.5 × 10^10
113
PRP components:
There may be a small number of residual red blood cells present, but the total number cannot exceed ______ red blood cells per component.
1.0 × 10^9
114
Adult transfusion normally requires ______ PRP platelet components, each prepared from one whole blood donation.
4–8
115
The _____ platelet production method reverses the steps that are used in PRP platelet production.
B/C
-Whole blood is first subjected to a “hard spin.” This causes the red blood cells to concentrate at the bottom of the unit, followed by the white blood cells and the platelets that sit on the red blood cell layer in a “buffy coat.” The plasma remains at the top of the bag. The centrifuged whole blood is placed on a semi-automated plasma press, resulting in three components: red blood cells, plasma, and a buffy coat.
116
The second step in B/C platelet production involves...
pooling buffy coats prepared from 4 to 6 whole blood donations, along with either one plasma component or a bag of platelet additive solution.
-Pooling is achieved by sterile docking the connection tubing of the satellite containers together.
117
What is sterile docking?
done using a small benchtop device that welds connection tubing together while maintaining a closed system.
118
Third step for B/C platelet production?
-The B/C pool is then centrifuged using a “soft spin.”
-The centrifuged B/C pool is placed on a semi-automatic plasma press, resulting in the platelets settling into one platelet storage container. Sometimes filters are used in this process to restrain white blood cells from entering the platelet component.
119
A B/C-pooled platelet component will contain how many platelets?
a variable number of platelets per component depending on the number of buffy coats pooled
120
_____ pooled B/C platelet is generally considered a normal adult dose for transfusion.
One
121
Not often prepared from _______ , as the apheresis collection technique results in a much higher number of granulocytes per collection.
whole blood
122
When a granulocyte component is prepared from whole blood, it is done by isolating the _________.
buffy coat
123
A granulocyte component prepared from whole blood generally contains _______ granulocytes and has a hematocrit of about____%.
1.25 × 10^9
4
124
Is apheresis done by an open or closed system?
closed
125
Most apheresis machines use _______ to separate the various whole blood components.
centrifugation
126
Apheresis can be used to collect what components?
plasma, platelet, red blood cell and granulocyte components
127
In addition to the product label, blood agencies are required to provide a ___________ to anyone involved in blood transfusion that provides critical information about each blood component and how it is to be used.
Circular of Information
128
Food and Drug Administration (FDA)
FDA Categories for Blood Establishments
Licensure and Registration means
Establishments collecting and producing blood products that engage in interstate commerce.
129
Food and Drug Administration (FDA)
FDA Categories for Blood Establishments
Registration Only means
Establishments collecting and producing blood products but acting solely within state borders.
130
Food and Drug Administration (FDA)
FDA Categories for Blood Establishments
Exempt from Registration and Licensure means
Transfusion services performing only minimal manufacturing activities and who are certified by Centers for Medicare and Medicaid Services (CMS).
131
Licensure and Registration
Facilities must register annually with the FDA via form ___________ if they collect, manufacture, prepare, or process blood products.
FDA 2830
132
Facilities that want to ship products across state lines must apply for ___________-
Licensure using the Biologics License Application (BLA; Form 356h).
133
Inspection
New facilities are inspected within _________ year by a team from the _____________
Subsequent inspections occur at least every ___________ years, depending on the compliance history of the facility.
one year
Center for Biologics Evaluation and Research (CBER) and Office of Regulatory Affairs (ORA).
two years
134
Inspection
The ________ publishes guidelines for inspectors, licensed facilities, and registered facilities.
ORA
135
Inspection
Routine inspections include evaluation of the
five layers of blood safety along with the operational systems that contribute to these layers
136
Inspection
A full inspection of all systems are designated a
Level 1 inspections
137
Inspection
If a facility has a favorable inspection profile, subsequent inspections may be
Abbreviated Level II inspections.
138
Inspection
If the investigator determines that objectionable practices or violations of regulations have occurred
They will document these observations in writing on Form 483 which is then presented to the facility.
139
Inspection.
The investigator is required to document _________
Management’s intention to correct deficiencies.
140
Inspection
Most facilities also respond in writing to the FDA, with documentation of corrective actions that address the deficiencies noted on __________
form 483
141
Violations
The FDA can respond to reported violations in several ways
way one
what action is taken if the violation is only a small degree of danger
They may take no action at all if the violation has been addressed and is considered to have posed a small degree of danger to the public.
142
Violations
way two
They may choose to issue a
Warning letter, which allows the facility to remedy the violation.
143
Violations
way three
They may take more
Severe action
144
Violations
The FDA divides enforcement actions into
Advisory, administrative, judicial, and recall actions.
145
Biological Product Deviation Reports
Report that manufacturers of blood components and plasma products use to report all instances of ___________
Errors or accidents that could potentially affect the safety, potency, or purity of a distributed product.
146
Biological Product Deviation Reports
The most frequent biological product deviation reported is.
Post-donation information
147
Biological Product Deviation Reports
The same form and online system are used to report
Biological deviations related to human tissue, cellular, and tissue-based products (HCT/P).
148
Medical Devices
Medical device regulations are mainly enforced by the
Center for Devices and Radiological Health.
149
The Center for Biologics Evaluation and Research (CBER) regulates some medical devices that are used in
in the manufacture of biologics.
150
Medical Devices
Medical devices include
software and reagents as well as testing and therapeutic instruments.
151
Medical Devices
Class I
Poses the least risk.
152
Medical Devices
Class II
-Includes many instruments and reagents used in blood banks and transfusion services.
-New Class II products can often apply for 510(k) clearance.
153
Medical Devices
Class III
Includes new devices that are unlike anything else on the market, poses the most potential risk.
154
Medical Devices
Manufacturers and users must report any fatalities or serious adverse events that are related to or suspected to be related to the use of medical devices to the
FDA using form 3500A.
155
Fatality Reporting
CBER centers for biologics evaluation and research
Blood product manufacturers, blood banks, and transfusion services must report all deaths that are related to blood donation or blood transfusions.
156
Fatality Reporting
The death must be reported as soon as possible, usually by
Telephone or email, and must be followed up with a written report within 7 days.
157
Human Tissue, Cellular and Tissue-Based Products (HCT/P)
The FDA enforces the regulations around human tissue and cellular products, but not _______
Solid organs.
158
Human Tissue, Cellular and Tissue-Based Products (HCT/P)
Solid organ transplants are monitored by the
Health Resources Services Administration.
159
Human Tissue, Cellular and Tissue-Based Products (HCT/P)
The FDA focuses on three areas of regulation of tissue and cellular products which are
-Minimizing the risk of communicable disease transmission,
-Establishing good manufacturing processes that will reduce the risk of contamination.
-Requiring that higher-risk products demonstrate safety and efficacy.
160
Human Tissue, Cellular and Tissue-Based Products (HCT/P)
The FDA regulations focus on facilities that collect or manipulate _____________ but not on facilities that ____________
Tissues and cells
that only receive, store, and administer tissue products.
161
State and Local Regulations
Laboratories must comply with all applicable.
State and local regulations.
162
In some cases, the state or local regulation may be more stringent or more detailed, and therefore would supersede
the federal regulation.
163
State and Local Regulations
Laboratories, as employers, must comply with applicable occupational health and safety regulations, which may be at the ________, _______, or __________ level.
Federal, state, or local level.
164
State and Local Regulations
As health care providers and employers, laboratories and laboratory professionals must be aware of and follow the
federal and state privacy laws that apply to their practices.
165
Two federal privacy laws that routinely affect laboratory operations in the United States are the what
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Reinvestment Act of 2009 (HITECH).
166
Most states or regions have mandatory reporting of notifiable infections to a
public health agency.
167
Blood banks performing infectious disease testing on donors must report
positive results as mandated by their state or local regulations.
168
States also set out the requirements for
licensure of medical professionals.
169
Requirements for certification or licensure of medical laboratory professionals vary among
states
170
Blood banks or transfusion services may also choose to seek what accreditation
Voluntary accreditation.
171
Some agencies that offer voluntary accreditation are
CMS-approved inspection agencies.
172
If the laboratory is using the inspection to meet its CLIA obligations, then the accreditation is
mandatory.
173
Generally speaking, voluntary accreditation agencies use a
Peer-review assessment process.
174
Most voluntary accreditation agencies align their assessment tools to ensure
Regulatory compliance but also to promote excellence beyond the minimum requirements outlined by regulation.
175
The two most common voluntary accreditations that apply to medical laboratories, including blood banks and transfusion services, are
AABB and College of American Pathologists.
176
A voluntary accreditation for plasma product producers is the
International Quality Plasma Program certification from the Plasma Protein Therapeutics Association.
177
American Association of Blood Banks (now known as AABB)
Formed in
1947
178
American Association of Blood Banks (now known as AABB)
Publishes various standards, including
they are updated every
Standards for Blood Banks and Transfusion Services; the standards are updated every 18 months.
179
American Association of Blood Banks (now known as AABB)
AABB-accredited facilities are assessed to the
current, applicable AABB Standard using a peer-review process.
180
American Association of Blood Banks (now known as AABB)
Renewal assessment visits are unannounced if occurring within the United States or Canada and occur every
2 years
181
American Association of Blood Banks (now known as AABB)
Additional assessments may occur if
A complaint is lodged against the facility or there is concern about the facility’s performance.
182
American Association of Blood Banks (now known as AABB)
A nonconformance occurs when a facility is not meeting an
applicable standard. Initial assessments and reassessments are announced.
183
American Association of Blood Banks (now known as AABB)
Findings are communicated to the facility throughout the __________, and a summary of both nonconformances and commendable practices identified during the assessment are presented to the facility’s management during a summary session.
assessment
184
American Association of Blood Banks (now known as AABB)
A written summary report outlining any _____________ is left with the facility’s management. The facility has ___ days in which to provide an action plan that addresses each reported nonconformance to the AABB.
nonconformances
30
185
American Association of Blood Banks (now known as AABB)
There are processes to challenge the validity of a _____________
nonconformance citing
186
American Association of Blood Banks (now known as AABB)
If an assessor notices a nonconformance that potentially poses a significant danger to _________, ___________, or ____________ the facility is required to take immediate action.
donors, recipients, or staff members
187
American Association of Blood Banks (now known as AABB)
Sometimes accredited facilities have a valid reason for not being able to meet a particular standard. If this occurs the facility can apply for a
variance.
188
Facilities that are both AABB and CAP-accredited can request a joint assessment, where the _____________
joint assessment, where the same assessor(s) uses one visit to complete an assessment and submit paperwork to both organizations.
189
College of American Pathologists (CAP)
founded in
Founded in 1946; issued the first accreditation certificates in 1964.
190
CAP
CAP standards have been modified into
detailed checklists, which are used by inspectors during the on-site inspection.
191
CAP-accredited facilities undergo a
on-site inspection every second year and complete a self-inspection during the intervening year.
192
CAP
The on-site inspection is unannounced and will occur within a
3-month period
193
CAP inspectors are employees of a CAP-accredited facility and complete an
online learning course about inspections.
194
CAP
The inspection visit follows a similar process to an
AABB assessment
195
CAP
The inspection team uses standardized forms to prepare a written summary that includes a list of
The identified deficiencies and presented their findings at a summation meeting with the facility’s management.
196
CAP checklist items are identified as
either phase I or phase II.
197
Laboratories must respond in writing to CAP within
30 days of the inspection and must address all identified deficiencies.
198
In 2006, the AABB moved toward adopting the ____________ global standard for blood component labeling.
ISBT 128
199
The ISBT 128 standard was developed in 1994 by the International Society for Blood Transfusion (ISBT) and provides standards for...
the information that must be present on the blood component label.
200
At minimum, the following critical pieces of information must be present on the ISBT 128 component label:
Donation identification number
Blood group of the donor
Product code and description
Expiration date
Special testing
201
red cell storage lesions include...
-Hemolysis is the most obvious impact of storage on red blood cells.
-Over time, older red blood cells undergo apoptosis, also known as preprogrammed cell death.
-Stored red blood cells maintain metabolic activity.
-Anaerobic storage conditions cause cellular hemoglobin to release oxygen.
-Many of these changes are reversible after transfusion, with intracellular potassium levels returning to normal within a few hours of transfusion.
-Membrane changes due to reduced levels of ATP may be irreversible, depending on storage conditions.
202
Ture or false: Platelets are very fragile and sensitive cells and can be adversely affected by temperature, forces applied during centrifugation, and other conditions that may be experienced through collection, production, and storage.
True
203
Stressors to platelets result in...
changes to the platelet cytoskeleton and impaired ability to aggregate.
-Changes are reversible early in the storage period, but storage over several days results in platelet degranulation and irreversible membrane changes.
204
Platelets have _____ levels of metabolic activity during storage
high
205
Platelets:
__________ is produced through glucose metabolism and __________ is produced through fatty acid metabolism.
Lactic acid, carbon dioxide
-Oxygen is consumed during these activities, while pH falls and carbon dioxide levels rise. Prolonged storage in this type of environment eventually leads to cell death.
206
WBCs are fragile and deteriorate very quickly once removed from the body, What are the risks of this?
When white blood cells break down, they release many active substances that accelerate cell death in red blood cells and platelets. Substances can also cause serious reactions in patients when the components are transfused.
207
True or false:
Most plasma proteins of interest in transfusion medicine are not stable in a wide range of storage conditions
False
very stable, with the exception of factors V and VIII that break down rapidly when plasma components are stored at temperatures above freezing.
208
Bacterial metabolism accelerates the destruction of...
red blood cells, white blood cells, and platelets.
209
Storage conditions are defined by what two things?
the temperature and the length of time of storage.
210
What is the purpose of reducing storage temperatures?
slowing cell metabolism and the breakdown of proteins. It also inhibits the growth of any bacteria that may be present.
211
The sensitivity of platelets necessitates special handling during storage. Providing continuous __________ to platelet components is important
agitation
212
The requirement to store platelets above __________ increases the risk that any bacteria in the system will proliferate.
68° F (20° C)
213
Additive solutions reduce hematocrit, which has been shown to reduce ___________ during storage.
hemolysis
214
What things can be added to platelet components to significantly improve platelet viability during storage?
adding potassium, magnesium, and L-carnitine
215
In general, products that must be stored at (1–6° C) must maintain a shipping temperature of ___________, while platelets and granulocytes must maintain a shipping temperature of __________.
(1–10° C)
(20–24° C)
216
Newer transportation systems use _________ materials to maintain temperatures for much longer periods of time.
phase-change
217
What are phase change materials?
a compound that shifts between a solid and a liquid state at a very specific temperature. It is able to store and release large amounts of energy in the form of heat and can act as an interceptor of heat energy in the shipping container.
218
It is important that blood products are maintained at the appropriate temperature during shipping, especially _________ units.
RBC
219
A process that removes white blood cells from whole blood or blood components
Leukoreduction
220
What is the purpose of leukoreduction?
to reduce the undesirable effects that white blood cells have on stored blood components and to reduce the risk of adverse reactions in patients receiving blood components.
221
__________ leukoreduction is done at the time of component production
Prestorage
222
The acceptable number of leukocytes that can remain is ______ per component in the United States and Canada and 1.0 × 10^6 per component in Europe.
5 × 10^6
223
How is Pathogen Inactivation done when treating plasma?
adding methylene blue, psoralen, or riboflavin to the component in a closed system, then exposing the component to light at specific wavelengths.
224
All methods of pathogen inactivation cause some reduction in...
in plasma clotting factors
225
Why might "pooling" be done?
to reduce the number of bags that have to be accessed at the time of transfusion.
226
Pooling is commonly done with __________ or _____________ to create a single treatment dose.
PRP platelets, cryoprecipitated AHF
227
Volume Reduction is done to remove...
and why?
plasma or additive solution from components.
Reduces the risk of circulatory overload and removal of excess plasma reduces the risk of adverse reactions related to transfusion of certain plasma proteins.
228
Volume Reduction:
Done by centrifuging cellular components and removing supernatant fluid, usually with a ________.
plasma press.
229
Ture or false:
Removing additive solution or plasma will affect the survival time of the RBCs or platelets.
True
230
Irradiation:
-Exposing blood components to gamma or x-ray radiation inactivates ___________ with no adverse effect on platelet or red blood cell function.
T lymphocytes
231
The acceptable dose of radiation delivered to the center of the component is a minimum of ___ Gy and a maximum of ____ Gy. Radation exposure at these levels have no impact on platelet function or viability.
25, 50
232
Irradiation of red blood cells has some impact on the cell membrane and irradiated red blood cells demonstrate increased potassium leakage into the storage fluid. Therefore, the expiration date for RBCs must be changed to ___ days or the original expiration date, whichever is shorter.
28
233
What is the purpose of washing?
to remove plasma proteins that can cause severe reactions in certain patient populations.
234
Washing is performed by using what?
sterile normal saline
235
What is the disadvantage of washing?
Usually occurs in an open system, which results in a shortened expiration date
236
What is the purpose of using glycerol when freezing RBCs?
-normally red cells undergo cell lysis when frozen and then thawed.
-Glycerol acts by limiting the formation of ice crystals within red blood cells, reducing damage to the cell membrane.
-Glycerol is added to the red blood cell component and the component is allowed to equilibrate before freezing.
237
Red blood cells that have been frozen in glycerol are thawed at ____C and the glycerol must be removed prior to transfusion.
98.6° F (37° C)
238
How is deglycerolization achieved?
washing the thawed component with successive concentration changes of sterile saline solution, starting with hypertonic saline.
239
A method used to reverse some of the adverse effects of storage on red blood cells.
Rejuvenation
240
Rejuvenating solutions contain what? which have the ability to return 2,3-DPG and ATP levels to normal levels in stored red blood cell components
-pyruvate
-inosine
-phosphate
-adenine
241
Rejuvenation:
The process can be done up to ____ days after a RBC unit expires.
3
242
True or false:
Rejuvenated red blood cells must be washed prior to transfusion to remove the rejuvenating solution.
True
243
Rejuvenation may also be done to improve the condition of red blood cells prior to....
freezing in glycerol.
244
Quality Assurance (QA) definition?
The monitoring performed to ensure that the quality system is being adhered to and is effective.
245
QA includes the following:
*Planning: What will be done?
*Retrospective review processes: What was done or not done?
*Analysis of performance data: Was it done the right way?
246
Quality Assurance (QA):
-Review processes include...
monitoring, auditing, trend analysis, and root-cause analysis of errors.
247
Quality Assurance (QA):
purpose of analysis of performance data?
to measure how well processes and personnel are functioning through audits, competency assessments, and proficiency testing.
248
Includes everything that is utilized to ensure that products, processes, or services within a department or organization meet or exceed expectations.
Quality System
249
Sometimes defined as the document that captures the quality program.
Quality System
250
Components of a quality system:
*Organization
*Personnel and hiring practices
*Training
*Equipment and supplier qualification
*Processes and process control
*Procedure manuals
*Documentation
*Methods to detect errors or deviations
*Error correction
*Quality controls
*Equipment calibration and maintenance
*Process and equipment validation
*Internal and external audits
251
-Addresses the interrelationship between systems and processes within an organization and between the organization and its suppliers and customers.
-Involves strategic and quality planning, validation, training and implementation with consideration for cost containment and risk management.
Quality Management (QM) System
252
Ensures that the overall quality program is effective and efficient with a continuous goal of process improvement and customer satisfaction.
Quality Management (QM) System
253
The three major components of a quality program are...
quality management (QM), quality assurance (QA), and quality control (QC).
254
Quality has been depicted as a three-legged stool. The seat of the stool is quality management. The three legs, all of which are essential to balance the stool, are...
*Compliance with government and accreditation requirements
*Meeting customer requirements and needs
*Controlling costs
255
*A quality approach that strives to eliminate all or nearly all defects from a process.
*Has proven to reduce costs and process time when implemented properly.
Six Sigma
256
* Focuses on eliminating waste.
* Quality improves because waste includes employee activities not adding value to the process; rework due to errors; and product, reagent, and supply discards.
Lean
257
__________ is a series of checks, tests, and challenges that ensure the equipment and/or process function as expected. It may be prospective, concurrent, or retrospective.
Validation
258
Three types of validation are specific for new equipment, including computer systems:
Installation qualification
Operational qualification
Performance validation
259
The ambient temperature of open areas where blood products are kept or stored must be recorded every ___ hours at a minimum.
4
260
True or false:
Transfusion of bacterially contaminated products usually produces a delayed reaction.
False
usually an immediate reaction
261
If a transfusion recipient notifies the transfusion service or blood bank that he has developed a viral infection and suspects it is related to transfusion, an investigation to identify and test all the donors implicated in his treatment will occur. This investigation is often called a _________.
traceback
262
A lookback is the process to track the disposition of blood products from previous donations when supplemental or confirmatory tests on a donor are positive for...
The lookback often does not originate from a recipient complaint, but rather as a result of testing when a donor returns to donate again.
anti-HIV, anti-HCV, or anti-Trypanasoma cruzi.
263
Tracebacks/lookback:
Notification of recipients is not required or desired in all cases, but is always required for...
hepatitis C, HIV, and T. cruzi.
264
If a transfusion service confirms or suspects that a TRALI reaction has occurred, they should immediately...
notify their blood supplier.
-A process similar to a traceback is used to identify potential donors implicated in causing the TRALI. In-date products from any implicated donors should be quarantined during the investigation.
265
________ action occurs in response to a reported event, has a goal of preventing recurrence of the event, and is reactive.
Corrective
266
________ action occurs in response to an identified potential for error, prevents an event from happening, and is proactive.
Preventive
267
_________ events (events resulting in a donor or patient experiencing a fatal, life-threatening, or serious adverse outcome or where there was potential for such an outcome to occur) should be flagged and acted on immediately.
Sentinel
268
OSHA regulates workplace safety at the _________ level.
federal
269
