Form Approved
OMB No. 0920-1011
Exp. Date 03/31/2017
2016 Urgent Assessment of Blood Collection and Use in Puerto Rico in Response to the Zika Virus Outbreak
Section A. General Information
Please
provide the contact information for the primary person responsible
for completing this section.
Prefix:
First Name:
Last
Name:
Title/Position:
Name of Institution:
Address
of Institution:
Telephone:
Email:
Please
provide the following information for the facility included in the
survey.
Facility Name:
Address:
City:
Zip
Code:
Facility Identifier (select one):
Medicare Provider Number:
American Hospital Association (AHA) Number:
VA Station Code:
FDA Establishment Number (FEI):
Which of the following best describes your institution?
A local or regional blood center (non-hospital) that collects blood from donors and supplies blood and components to other institutions, but does not perform transfusion services
A hospital-based blood bank and transfusion service that collects blood from donors (may be only autologous or directed) and provides blood and components for transfusion primarily to your own institution
A transfusion service that provides blood and components for transfusion, but does not collect blood from donors
A local or regional blood center that collects blood from donors and supplies blood, components, and cross matched blood products to participating facilities (e.g., centralized transfusion services). In this category, the service is not limited to reference laboratory work, but includes routine transfusion service work
Section B. Blood Collection, Processing, and Testing
Please
provide the contact information for the primary person responsible
for completing this section.
Prefix:
First Name:
Last
Name:
Title/Position:
Name of Institution:
Address of
Institution:
Telephone:
Email:
Does your institution collect blood from donors? (Even if you collect autologous units only, check “Yes.”)
Yes
No (if ‘No’, end of section)
In 2015, how many collections were successfully completed by your institution in each of the following categories? (* indicate required fields)
|
Number of Collection Procedures* |
Number of Units |
Whole Blood |
|
|
Allogeneic (non-directed donations)* |
|
|
Autologous* |
|
|
Directed* |
|
|
Total* |
|
|
|
|
|
Red Blood Cells |
|
|
Apheresis |
|
|
Allogeneic* |
|
|
Autologous* |
|
|
Directed* |
|
|
Concurrent red cells (from apheresis platelets) |
|
|
Total Apheresis Red Blood Cells* |
|
|
Whole-blood-derived |
|
|
Allogeneic* |
|
|
Autologous* |
|
|
Directed* |
|
|
Total WBD Red Blood Cells* |
|
|
|
|
|
Platelets |
|
|
Apheresis |
|
|
Single-donor |
|
|
Directed single-donor |
|
|
Single collection |
|
|
Double collection1 |
|
|
Triple collection1 |
|
|
Total Apheresis Platelets* |
|
|
Total apheresis platelet units subjected to pathogen reduction technology |
|
|
Whole-blood-derived |
|
|
Individual*2 |
|
|
Total whole blood-derived individual units subjected to pathogen reduction technology |
|
|
|
|
|
Plasma |
|
|
Apheresis |
|
|
FFP |
|
|
PF24 |
|
|
PF24RT24 |
|
|
Jumbo FFP (>400 mL) |
|
|
Total Apheresis Plasma* |
|
|
Total Apheresis plasma units subjected to pathogen reduction technology |
|
|
Whole-blood-derived |
|
|
FFP |
|
|
PF24 |
|
|
Cryoprecipitate reduced |
|
|
Liquid |
|
|
Total WBD Plasma* |
|
|
Total WBD plasma units subjected to pathogen reduction technology |
|
|
|
|
|
Cryoprecipitate |
|
|
Individual*3 |
|
|
|
|
|
Total Granulocytes* |
|
|
1 Count double collections as two units and triple collections as three units
2 Enter the number of individual platelet units prepared from whole blood collections
3 Enter the number of individual cryoprecipitate units prepared from whole blood collections
In 2015, from how many of the following types of donors did your institution successfully collect blood products?
|
Number of Donors |
First-time allogeneic donors |
|
Repeat allogeneic donors (Count multiple donations from a single repeat donor only once) |
|
Directed donors |
|
Autologous donors |
|
Total number of donors |
|
In 2015, how many units of each product were imported, distributed, and outdated by your institution? (* indicate required fields)
|
Total Units Imported |
Total Units Distributed (including imported units)1 |
Total Units Outdated |
Whole Blood for distribution as Whole Blood |
|
|
|
Allogeneic (non-directed donations) |
|
|
|
Autologous |
|
|
|
Directed |
|
|
|
Total* |
|
|
|
|
|
|
|
Red Blood Cells |
|
|
|
Apheresis |
|
|
|
Allogeneic |
|
|
|
Autologous |
|
|
|
Directed |
|
|
|
Concurrent red cells (from apheresis platelets) |
|
|
|
Total Apheresis Red Blood Cells* |
|
|
|
Whole-blood-derived |
|
|
|
Allogeneic |
|
|
|
Autologous |
|
|
|
Directed |
|
|
|
Total WBD Red Blood Cells* |
|
|
|
|
|
|
|
Platelets |
|
|
|
Apheresis |
|
|
|
Single-donor |
|
|
|
Directed single-donor |
|
|
|
Single collection |
|
|
|
Double collection2 |
|
|
|
Triple collection2 |
|
|
|
Total Apheresis Platelets* |
|
|
|
Whole-blood-derived |
|
|
|
Individual* |
|
|
|
Pooled3 |
|
|
|
|
|
|
|
Plasma |
|
|
|
Apheresis |
|
|
|
FFP |
|
|
|
PF24 |
|
|
|
PF24RT24 |
|
|
|
Jumbo FFP (>400 mL) |
|
|
|
Total Apheresis Plasma* |
|
|
|
Whole-blood-derived |
|
|
|
FFP |
|
|
|
PF24 |
|
|
|
Cryoprecipitate reduced |
|
|
|
Liquid |
|
|
|
Total WBD Plasma* |
|
|
|
|
|
|
|
Cryoprecipitate |
|
|
|
Individual* |
|
|
|
Pooled4 |
|
|
|
|
|
|
|
Total Granulocytes* |
|
|
|
1 Units returned and distributed more than once should be counted only once
2 Count double collections as two units and triple collections as three units
3 Total number of platelet pools prepared from whole blood collections
4 Total number of cryoprecipitate pools prepared from whole blood collections
What was the average whole dollar amount your institution was reimbursed (by hospital or clinical facility) per unit in 2015 for the following components? (Include discounts in your calculations. If you do not use a particular component, select “Not Applicable”. CPT/HCPCS codes are in in parenthesis.)
|
Average Amount Paid Per Unit ($) |
Plasma, single donor, frozen with 8 hours of phlebotomy (P9017) |
|
Plasma, frozen between 8 and 24 hours of phlebotomy (P9059) |
|
Red cells, leuko-reduced (P9016) |
|
Red cells, non-leuko-reduced (P9021) |
|
WBD platelets, each unit, not leuko-reduced, not irradiated (P9019) |
|
Apheresis platelets, leuko-reduced (P9035) |
|
Cryoprecipitate, each unit (P9012) |
|
If your facility does not use pathogen reduction technology for apheresis platelet or plasma collections, what is the estimated total cost of implementation (this includes equipment, capital investment, training, etc)? What is the estimated additional cost per each unit type below if your facility adopted pathogen reduction technology?
Section C. Blood Transfusion
Please
provide the contact information for the primary person responsible
for completing this section.
Prefix:
First Name:
Last
Name:
Title/Position:
Name of Institution:
Address of
Institution:
Telephone:
Email:
Does
the following information match your institution?
[show the
name, address, facility identifier (AHA?) for the facility assigned
to the link]
Yes [users will continue with the section]
No [users will not be able to continue with the section and will be prompted to contact us]
Is your institution directly involved in the transfusion of blood to patients?
Yes
No
(if ‘No’, end of section)
In 2015, how many units of allogeneic whole blood and red blood cells did your institution transfuse? (Leave the field blank if you do not know the answer).
|
Total Number of Units Transfused |
Total number of Recipients |
Total outdated units |
Allogeneic Whole Blood |
|
|
|
Allogeneic Red Blood Cells (include all blood groups) |
|
|
|
Allogeneic Group O Positive RBCs |
|
|
|
Allogeneic Group O Negative RBCs |
|
|
|
Indicate the disposition of directed and autologous units in 2015.
|
Total Number of Units Transfused to Intended Recipient |
Total Number of Recipients |
Outdated Units |
Directed Whole Blood Units |
|
|
|
Directed RBC Units |
|
|
|
Autologous Whole Blood Units |
|
|
|
Autologous RBC Units |
|
|
|
In 2015, how many units of each of the following components did your institution transfuse and how many units were outdated while on your shelf (include units transfused to pediatric patients)? (* indicates required fields)
(include all blood groups) |
Total Number of Units Transfused |
Total Number of Units Outdated |
WBD Platelets (individual concentrates and pools expressed as individual concentrate equivalents)* |
|
|
Apheresis Platelet units – Full dose* |
|
|
Directed Platelets to intended recipients |
|
|
Total Plasma* |
|
|
Fresh Frozen Plasma (FFP) |
|
|
FFP, pediatric size (≤100 mL) |
|
|
Plasma, Frozen within 24 hours (PF24) |
|
|
PF24RT24 |
|
|
Jumbo FFP (>400 mL) |
|
|
Liquid plasma |
|
|
Directed plasma to intended recipients |
|
|
Thawed plasma |
|
|
Plasma, cryoprecipitate reduced |
|
|
Group AB plasma |
|
|
Cryoprecipitate (include individual units and pools expressed as unit equivalents)* |
|
|
Granulocytes* |
|
|
Indicate the total number of units transfused to pediatric populations in 2015.
|
Number of Adult Equivalent Units in Whole or in Part for Pediatric Patients1 |
Total Number of Pediatric Recipients |
Whole Blood |
|
|
RBCs |
|
|
Plasma |
|
|
Platelets |
|
|
1 This should be a subset of data reported in question 4 and 5 if your hospital transfuses non-pediatric patients.
Indicate how many irradiated, leuko-reduced, and leuko-filtered units for each of the following components your institution transfused in 2015. For pediatrics, use the number of adult equivalent units used in whole or part. For components that are irradiated and leuko-reduced, include these in the count for both columns.
|
Components Irradiated |
Components Leuko-reduced Before or After Storage (not at bedside) |
Components Leuko-filtered at the Bedside |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total components (if the number for a-d is ‘unknown’, enter the total number of components for the modification) |
|
|
|
Does your institution have a policy to transfuse only leuko-reduced (LR) components?
Yes
No
9a. In 2015, how many total units of RBCs transfused were…
|
Number of Units |
|
1 – 35 day(s) old |
|
|
36 – 42 days old |
|
|
9b. In 2015, how many total units of WBD platelets transfused were…
|
Number of Units |
|
1 – 3 day(s) old |
|
|
4 – 5 days old |
|
|
9c. In 2015, how many total units of Apheresis platelets transfused were…
|
Number of Units |
|
1 – 3 day(s) old |
|
|
4 – 5 days old |
|
|
In your institution, on average, how many individual platelet units were included in a pooled WBD platelet dose in 2015?
< 3
3
4
5
6
7
8
9
10
> 10
Not
applicable
Indicate the number of units that were transfused in inpatient or outpatient settings.
|
Number of RBC Units |
Number of Platelet Units |
Total |
Don’t Know |
All Surgery (including transplant) |
|
|
|
|
Inpatient Medicine (including hematology/oncology) |
|
|
|
|
Emergency Department |
|
|
|
|
Obstetrics/Gynecology |
|
|
|
|
|
|
|
|
|
Pediatrics |
|
|
|
|
Neonates |
|
|
|
|
Critical Care |
|
|
|
|
Outpatient and non-acute inpatient settings1 |
|
|
|
|
1 E.g., outpatient dialysis, rehabilitation, long term care, etc.
Does your institution routinely order plasma transfusions to non-pediatric patients based on:
Weight based dosing (e.g., 20mL/kg)
A standard number of units regardless of patient weight (e.g., 4 or 6 units)
Dosage varies based on perceived level of coagulation factor deficiency or degree of bleeding
Number of units ordered is not consistent with any of the above
13a. Does your institution routinely order prophylactic platelet transfusions to non-pediatric patients based on:
Weight based dosing (e.g., 20mL/kg)
A standard number of units regardless of patient weight (e.g., 4 or 6 units)
Dosage varies based on perceived level of thrombocytopenia or degree of bleeding
Number
of units ordered is not consistent with any of the above
13b. Does your institution routinely order therapeutic platelet transfusions to non-pediatric patients based on:
Weight based dosing (e.g., 20mL/kg)
A standard number of units regardless of patient weight (e.g., 4 or 6 units)
Dosage varies based on perceived level of thrombocytopenia or degree of bleeding
Number of units ordered is not consistent with any of the above
What was the average whole dollar amount your institution paid per unit in 2015 for the following components? (Include discounts in your calculations. If you do not use a particular component, select “Not Applicable”. CPT/HCPCS codes are in in parenthesis.)
|
Average Amount Paid Per Unit ($) |
Plasma, single donor, frozen with 8 hours of phlebotomy (P9017) |
|
Plasma, frozen between 8 and 24 hours of phlebotomy (P9059) |
|
Red cells, leuko-reduced (P9016) |
|
Red cells, non-leuko-reduced (P9021) |
|
WBD platelets, each unit, not leuko-reduced, not irradiated (P9019) |
|
Apheresis platelets, leuko-reduced (P9035) |
|
Cryoprecipitate, each unit (P9012) |
|
15a. Were any elective surgeries postponed due to blood inventory shortages in 2015?
Yes
No
Don’t
know
(if No or Don’t know, skip 15b and 15c)
15b. How many days were elective surgeries postponed?
[Free text, numeric values only] day(s)
Don’t know
15c. How many elective surgeries were postponed in 2015?
[Free text, numeric values only] surgeries
Don’t know
In 2015, how many days was your institution’s order incomplete for the following components?
|
Number of days |
Whole Blood |
|
RBCs |
|
Plasma |
|
Apheresis platelets |
|
WBD platelets |
|
In 2015, how many days were you unable to meet other non-surgical blood requests (e.g., red cells, platelets)?
[Free text, numeric values only] day(s)
Don’t know
Does your institution have an established program to treat patients who refuse any or all blood components for religious, cultural, or personal reasons?
Yes
No
19a. Does your institution have a Transfusion Safety Officer (TSO)?
Yes
No
(if
No, skip 19b and 19c)
19b. If yes, how many full-time equivalent TSOs? (Consider two part-time employees as a single full-time equivalent)
[Free text, numeric values only] full-time equivalents
19c. Is the TSO employed by your institution or by the blood center?
Institution employee
Blood center employee
At your institution, how many units of Group O red cells are on your shelf on an average weekday?
[Free text, numeric values only] units
At what number of Group O positive and Group O negative RBC units in uncrossmatched inventory do you consider your inventory to be “critically low”?
[Free text, numeric values only] units
How many Whole Blood/RBC crossmatch procedures were…
|
Number of Procedures |
performed at your institution in 2015 by any method? |
|
electronic crossmatch procedures? |
|
manual serologic crossmatch procedures? |
|
automated serologic crossmatch procedures? |
|
23a. Does your institution type red blood cell antigens using a molecular assay (e.g., genotyping)?
Yes
No (if No, skip 23b)
23b.
How many red blood cell units from donors who were genotyped (e.g.,
using a molecular assay) were transfused by your institution in 2015?
[Free text, numeric values only] units
How many samples (patient specimens submitted for testing) did your institution receive at the blood bank in 2015?
[Free text, numeric values only] samples
Does your facility have an electronic system for tracking transfusion-related adverse events (e.g., unplanned, unexpected, and undesired occurrences)?
Yes
No
26a. Did your institution collect data on sample collection errors (e.g., wrong blood in tube) in 2015?
Yes
No
(if
No, skip 26b)
26b. How many transfusion sample collection errors were reported in 2015?
[free text, numeric values only] errors
How many transfusion-related adverse reactions were reported to the transfusion service in 2015?
[Free text, number values only] reactions
Complete the table below to indicate how many of each type of reaction occurred:
|
Number of reactions |
Life-threatening, required major medical intervention following transfusion (e.g., vasoporessors, blood pressure support, intubation, or transfer to the ICU) |
|
Transfusion-related acute lung injury (TRALI) |
|
Transfusion-associated circulatory overload (TACO) |
|
Acute hemolytic transfusion reaction (ABO) |
|
Acute hemolytic transfusion reaction (other antibodies) |
|
Delayed hemolytic transfusion reaction |
|
Delayed serologic transfusion reaction |
|
Febrile, non-hemolytic transfusion reaction |
|
Hypotensive transfusion reaction |
|
Post-transfusion purpura |
|
Transfusion-associated dyspnea |
|
Transfusion-associated graft-vs-host disease |
|
Transfusion transmitted bacterial infection |
|
Transfusion transmitted parasitic infection |
|
Transfusion transmitted viral infection |
|
Mild to moderate allergic reaction |
|
Severe allergic reaction |
|
28a. Does your institution perform pre-transfusion bacterial testing on platelets?
Yes
No (if No, skip 28b and 28c)
28b. Indicate what methods are used by your institution to test for bacterial contamination.
|
Culture-based testing |
Rapid immunoassay (e.g., VERAX) |
Other, specify |
Not tested |
Not applicable |
Apheresis platelets |
□ |
□ |
□ |
□ |
□ |
WBD platelets, singly |
□ |
□ |
□ |
□ |
□ |
WBD platelets, pooled |
□ |
□ |
□ |
□ |
□ |
[Specify other methods, free text, alpha numeric values]
28c.
How many confirmed positives and false positives were detected by
each method in 2015?
|
Number tested |
Number of confirmed positives |
Number of false positives |
Number of indeterminate results |
Not applicable |
Culture-based testing |
|
|
|
|
□ |
Rapid immunoassay (e.g., VERAX) |
|
|
|
|
□ |
Other methods |
|
|
|
|
□ |
Survey Glossary
Autologous: Self-directed donations.
Centralized transfusion service: A hospital or blood center that collects blood from donors and supplies blood, components, medical services and/or crossmatched blood products to multiple transfusing facilities.
Collected: Successful whole blood or apheresis collections placed into production (not QNS, or other removals).
Deferrals: The number of donors deferred for specific reasons:
Donors deferred for low hemoglobin do not meet the current FDA blood hemoglobin level requirements for blood donation.
Deferrals for other medical reasons may include the use of medications on the medication deferral list, growth hormone from human pituitary glands, insulin from cows (bovine, or beef, insulin), Hepatitis B Immune Globulin (HBIG), unlicensed vaccines, or presenting with physical conditions or symptoms that do not qualify a person to be a blood donor.
High-risk behavior deferrals include deferrals intended to reduce the risk of transmission of infectious diseases including HIV and hepatitis viruses. Examples of questions intended to identify these risks are sexual contact (e.g., men who have sex with men (MSM)) and non-medical injection drug use questions.
Travel deferrals are deferrals for travel to a specific region of the world.
Directed: Allogeneic donations intended for a specific patient.
Donation: The collection of a unit of blood or blood component from a volunteer donor.
Dose/Dosage: a quantity administered at one time, such as a specified volume of platelet concentrates.
First-time allogeneic donor: A donor who is donating for the first time at your center.
Imported: Units not collected by your institution, but obtained by your institution from another institution for distribution to a transfusion facility.
Modify: Procedures applied by a blood center, hospital blood bank, or transfusion service that may affect the quality or quantity of the final product (e.g., irradiation, leukofiltration, or production of aliquots of lesser volume).
Outdated: Units that expire on your shelf.
Plasma:
Plasma, frozen within 24 hours of phlebotomy (PF24): plasma separated from the blood of an individual donor and placed at -18 C or colder within 24 hours of collection from the donor.
Fresh frozen plasma (FFP): Plasma frozen within 8 hours of collection.
Plasma, Jumbo: FFP having a volume greater than 400 mL.
Plasma frozen within 24 hours of phlebotomy and held at room temperature up to 24 hours after phlebotomy (PF24RT24): Plasma held at room temperature for up to 24 hours after collection and then frozen at -18 C or colder.
Recipient: A unique individual patient receiving a transfusion one or more times in a calendar year.
Distributed: units that have fulfilled all processing requirements and have been made available for transfer to customers.
Repeat allogeneic donor: A donor who has previously donated a blood component.
Severe Donor-Related Adverse Events: adverse events occurring in donors attributed to the donation process that include, for example, major allergic reaction, arterial puncture, loss of consciousness of a minute or more, loss of consciousness with injury, nerve irritation, etc.
Transfusion Related Adverse Reactions: An undesirable response or effect in a patient temporally associated with the administration of blood or blood components. For a list of adverse reaction types and case definitions, visit http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf.
Transfusion Service: a facility that performs, or is responsible for the performance of, the storage, selection, and issuance of blood and blood components to intended recipients.
Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74 Atlanta, Georgia 30333; ATTN: PRA (0920-1011)
File Type | application/msword |
File Title | Emergency Epidemic Investigations |
Author | lmp2 |
Last Modified By | Zirger, Jeffrey (CDC/OD/OADS) |
File Modified | 2016-02-17 |
File Created | 2016-02-17 |