• Self-administered health history questionnaire to determine donor eligibility using web technology and mobile operating system technology
• Staff entered physical to determine donor eligibility
• Provide information data regarding the suitability of a donor making a donation
• Defer donors when they are prohibited from making a donation
• Store patient information during the manual crossmatch / consultation process
• Store and review test results for all units processed at a blood center, either through manual entry and/or instrument interfaces
• Label components based on Codabar and ISBT standards
• Ability to pool products (i.e., platelets, cryoprecipitate) into single components
• Interfaces with LifeTrak and Vista

Patient Health Software (P.H.S) Version 2.0

The Patient Health Software (PHS) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to: blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. PHS is designed to aid and assist qualified and trained personnel to support the operations within their facilities. PHS software supports single, centralized multi-sites and multi-organizations to be used centrally or in stand-alone.
PHS undertakes process controls for testing laboratory and transfusion service operations on testing on patients, manages, tracks and determines the suitability of the blood components and blood derivatives to reduce human error and contribute to patient safety.
PHS is intended to address all phases of laboratory activities and/or transfusion services operations at laboratory department, transfusion service departments, hospital wards and patient bed side. Functionality is provided for:
• Patient identification at bed side and patient record management;
• Supporting Patient immunohematology, virology, histocompatibility laboratory testing used for suitability and including reagent quality control;
• Supporting human leukocyte antigen (HLA) laboratory testing for suitability;
• Blood components preparation, release and labeling (ISBT 128);
• Blood components selection, testing and issue of blood components under normal and emergency conditions, including serological crossmatch, electronic crossmatch and remote crossmatch of blood components;
• Tracking of blood components disposition, record transfusion details and related outcome and record keeping of patient transfusion history for lookback.

MAK-SYSTEM SA International Group

10 Avenue de la Grande-Armee,
Paris, 75017,
France

ID CORE XT

Molecular erythrocyte typing test

Progenika Biopharma, S.A.

Ibaizabal bidea,
Edificio 504,
Derio, Bizkaia, 48160

ID CORE CONTROL

The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL I and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2) of the 29 polymorphisms interrogated by ID CORE XTTM. Both control vials must be used in every run of the ID CORE XT test.
ID CORE CONTROL samples are not intended to monitor the DNA extraction step of the ID CORE XTTM processing protocol.

Progenika Biopharma, S.A.

Ibaizabal bidea,
Edificio 504,
Derio, Bizkaia, 48160

HemoMix 3 with DCSX Software

Blood Mixing and blood weighing device

Delcon S.R.L

Via Zanica,
Grassobbio,
BG, 24050,

VistA Blood Establishment Computer Software (VBECS) Version 2.3.0

Blood Establishment Computer Software and Accessories

VistA Blood Establishment Computer Software (VBECS) is a computer software application that manages transfusion service activities. The purpose of VBECS is to automate the documentation and record keeping of selected daily activities of the transfusion service.

Department of Veterans Affairs

P.O Box 7008,
5th Ave and Roosevelt Rd,
Hines, IL 60141,

• a standalone or multiple IH-1000 systems,
• a standalone or multiple IH-Reader 24 systems,
• a standalone TANGO infinity® or multiple TANGO infinity® systems;
  or connected to a Laboratory Information System.

IH-Com V5.0 should only be operated by trained personnel and is not intended for use in a direct patient environment. In the USA IH-Com V5.0 is “Rx only”.

The IH-Reader 24 may only be operated by trained personnel and is not intended for use in a direct patient environment. Use of the IH-Reader 24 is only permitted in conjunction with the corresponding software or in a configuration authorized by Bio-Rad. IH-Reader 24 is allowed to use gel cards from the IH-System authorized by Bio-Rad. The use of any material not specified in the User Manual (e.g. non-authorized substances) is under the users' responsibility.

• Tracking of donor products from receipt to final disposition
• Specimen cross matching
• Specimen electronic crossmatching
• Determining the suitability of released products upon issuing
• Recording of transfusion information
• Tracking product disposition

The MEDITECH Blood Bank Software interfaces to the following Blood Bank Analyzer for the purposes of specimen resulting and transmitting the results to the MEDITECH Blood Bank Software: Galileo Echo

The software also allows online inquiries and permanent storage of:

• Donor history
• Crossmatch results
• Antigens/Antibodies
• Transfusion data
• Unit history
• Patient's comprehensive blood bank history

The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients.

Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:

• Double ACD-A/AS-3 Red Blood Cells (leukocytes reduced or not leukoreduced)

Or the following products alone or in combination:

• ACD-A/AS-3 Red Blood Cells
• ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced utilizing an integrated filter (TLR gravity drain filter or Auto RBC filter)
• Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
• Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (Isoplate) (single, double, or triple units)
• Plasma

Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. Platelets Pheresis, Leukocyte Reduced, Platelet Additive Solution (Isoplate) (single or double units) may be further processed (e.g., irradiated, divided). Platelets Pheresis, Platelet Additive Solution (Isoplate) (single or double units) may not be manufactured from products that do not meet leukocyte reduction product standards.

The storage conditions of the Trima Platelet bag (ELP bag) have been verified for storage up to 7 days post-collection in 100 % Plasma and up to 5 days in Isoplate Solution (PAS-F). Additionally, for storage up to 7 days, every product must be tested with a bacterial detection device cleared by FDA and labeled as a “safety measure.”

The Trima Blood Component Sampling Assembly, which is either integrated into the disposable tubing sets or as an accessory for sterile connection, is intended to allow aseptic removal of a sample from the platelet bag for subsequent bacterial or other applicable testing. The Sampling Assembly does not have contact with blood fluids that are reinfused to a donor or patient.

• Adequate studies have not been performed to evaluate the effect of gamma irradiation or freezing on the quality of ACD-A/AS-3 red blood cells products (RBCs) collected with gravity drain leukoreduction process (TLR filter) on the Trima Accel system.
• Studies have not been performed to support gamma irradiation or freezing of ACD-A/AS-3 RBCs collected with an integrated in-line RBC leukoreduction filter(s) (Auto RBC filter) on the Trima Accel system

BD BACTEC™ Platelet Aerobic/F Culture vials are used with the BD BACTEC™ FX instrument series for quality control of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Aerobic/F Culture vials support the growth of aerobic microorganisms (bacteria and fungi).

BD BACTEC™ Platelet Anaerobic/F Culture Vials are used with the BD BACTEC™ FX instrument series for quality control of leukocyte reduced apheresis platelet (LRAP) units, both leukocyte reduced single and a pool of up to 6 units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BD BACTEC™ Platelet Anaerobic/F Culture Vials support the growth of anaerobic microorganisms.

SafeTrace Tx is an electronic information system used by single-site, multi-site and centralized transfusion services to manage the blood transfusion process. It manages and tracks blood product information from receipt to final shipment and disposition.

SafeTrace Tx is an electronic information system that manages the blood transfusion process and assists in the determination of the suitability of released products. It manages and tracks blood product information relating to receipt, reservation, modification, testing, and final shipment and disposition. The application manages and provides a centralized view of patient, visit, and order information, including positive patient identification and patient, testing and transfusion history.

The system can perform electronic crossmatching and safety and compatibility checks between patient and product. Component attributes, such as human leukocyte antigen (HLA) attributes, can be entered into SafeTrace Tx.

SafeTrace Tx can operate stand-alone or interface with:

• Labeling systems
• Test lab systems, analyzers, and equipment
• Hospital information systems
• Laboratory information systems
• Blood tracking and/or storage devices
• Inventory systems (including other Blood Establishment Computer Software (BECS) systems)

• Dynamic donor eligibility status
• Register, track, and audit donations and deferrals
• On-line health history, physical findings, and collection process
• Inter-active donor questionnaire (staff and/or donor/remote donor)
• HLA/RBC search and match
• Donor Schedules
• Component production and modification
• Testing
• Labeling
• Imported blood processing
• Inventory management
• Distribution
• Material Check-In
• Offline Data Entry (Re-entry if downtime)
• LifeTrak is usable with wired/wireless networks supporting TCP/IP protocols

• a standalone IH-1000, with multiple IH-1000 systems;
• a standalone TANGO infinity®; or multiple TANGO infinity®; systems; or connected to a Laboratory Information System.

BacT/ALERT® BPA culture bottles are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi). BacT/ALERT® BPN culture bottle are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic and facultative anaerobic microorganisms (bacteria).

BacT/ALERT Microbial Detection Systems and culture bottles may be used for quality control testing of platelets and as a secondary safety measure test. Bacterial tests are labeled as safety measure when they show benefit for detection of bacterial contamination not revealed by previous bacterial testing. The laboratory should follow its own quality control procedures for these uses.

The UltraCW®II Automatic Cell Washing System is intended to be used for the washing portion of routine blood bank and laboratory procedures calling for washed red blood cells such as antiglobulin testing, ABO compatibility, Rh, cross matching and anti-body screening.

The UltraCW®II Automatic Cell Washing System should be operated by a trained individual such as a clinical laboratory technologist or similar education as determining whether desired results have been achieved is subjective and is dependent upon user preparation of blood sample, and parameter selection/adjustment.