Abstract:
A system and method of tracking, assigning and releasing biological fluids. The system and method identifies, assigns and releases biological fluid products from controlled storage based on medical criteria supported by the use of RFID technology.

Description:
RELATED US APPLICATION DATA 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/067,661 filed on Oct. 23, 2014, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Avoidance of transfusion error in blood product administration is critical to patient safety. Mismatch of blood type (ABO/Rh) during transfusion can result in patient illness or death. 
         [0003]    Use of technology to enhance the blood product selection protocol ensures the correct selection of each unit of blood for transfusion into each patient. The goal is to minimize the chance of human error in blood product type (ABO/Rh) selection as well as ensuring against outdated blood being selected. Giving medical professionals a more comprehensive search for blood product freshness and cross-match selection capabilities improves patient outcomes and in some cases will favorably impact patient survival. 
       SUMMARY OF THE INVENTION 
       [0004]    The system has one or more tray assemblies each with a plurality of bins to hold biological fluid containers for computer-directed assignment to patients in response to authorized orders. These may include any biological fluid including blood products, parental drugs, stem cells or even breast milk. For exemplary purposes, an embodiment wherein the containers described are blood product containers and the tray assemblies are stored on shelves or in drawers within a hospital refrigerator. Other configurations, such as platelet bags in a warmer unit are functionally equivalent. 
         [0005]    The primary function of the system is to provide a real-time interface between a physician, nurse or technician and a blood product storage system to ensure that the correct blood product is selected for administration to the correct patient. This is especially important when blood is needed in emergency situations from local storage units in emergency rooms, trauma centers and surgical suites. By assisting the human element as much as possible in the blood product selection process, it will help to ensure that the correct blood product bag is selected for transfusion into the correct patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, where like reference numbers in the drawing figures refer to the same feature or element and may not be described in detail for every drawing figure in which they appear and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the invention. 
           [0007]      FIG. 1  is a schematic perspective view of an exemplary tray assembly containing a plurality of blood product bags. 
           [0008]      FIG. 2  shows a schematic isometric view of a tray assembly as installed in the drawer of a biologic fluid storage refrigerator. 
           [0009]      FIG. 3  is a schematic perspective view of the tray assembly grating used to form the tray assembly bins for storage of biologic fluid products. 
           [0010]      FIG. 4  is a schematic top view of the tray assembly grating shown in  FIG. 3 . 
           [0011]      FIG. 5  shows an exemplary barcode label and an RFID tag as mounted on an empty biologic fluid container. 
           [0012]      FIG. 6  shows a schematic block diagram of the electronics, communications links and computer systems used. 
           [0013]      FIG. 7 . shows a schematic diagram of the wireless induction power system of the tray assembly. 
           [0014]      FIG. 8 . shows a schematic diagram of the refrigerator portion of wireless induction power system for the trays. 
       
    
    
     DETAILED DESCRIPTION 
       [0015]    Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details and construction and the arrangement of components set forth in the following description, or illustrated in the following drawings. The invention is capable of other embodiments and combinations of hardware, software and electronics which are functionally equivalent within the scope of the claims set forth below. 
         [0016]    The key elements of this system are tray assemblies used in a storage system which detect and hold radio frequency identification (RFID) tagged biological fluid containers and a local fluid management computer system which maintains a real-time database of the local refrigerator inventory and assists in assignment of specific biological fluid units in the inventory to specific patients in response to authorized orders, such as physician transfusion orders. 
         [0017]    The invention incorporates the following functionalities:
       Auto-Discovery: Capability for real-time updating of local refrigerator inventory transactions and requests for automatic replenishment from the central hospital biologic fluid storage, such as a blood bank.   Display Indicator: Next to each biological fluid container in each bin is a bin status indicator display to provide positive indications of a unit&#39;s status or selection for removal. Only the indicated authorized units can be removed from storage without an alarm.   Bedside Validation: Data may optionally be written in the RFID chip of the biological fluid container to provide a seamless validation of the assigned patient to ensure assignment of the correct unit for transfusion into the correct patient. Alternatively, data on the allocated biological fluid containers may optionally be communicated to the hospital information network enabling it to drive the bedside validation.   Resident Data: Data files containing detailed information about each biologic fluid storage container and its contents is resident on the database associated with the local biological fluid container system containing it. This way the information is always available at time of patient assignment.   Compatibility: Usable with the majority of industry software, such as blood banking software, for banks and hospitals. Using mirrored data volumes routine electronic blood type look up may be performed from with software from one or more software vendors.   Freshness Rotation: Due to the real-time nature and our ability to keep data directly on the unit, when blood type look up is performed it returns a display of available blood oldest first. A push button on the user interface may be applied to reorder the displayed inventory to freshest first.   Greater Search Criteria: Search and selection criteria are not limited to just the ABO blood group   Communications: A wide variety of communications protocol, including the use of multiple systems in each data path.   Retrofitability: The tray assemblies may be easily retrofit into existing blood storage refrigerators. Tray assemblies may be battery powered and charged wirelessly via an inductive battery chargers. Wireless communications with each tray assembly avoids the need for communication wiring to each tray assembly.       
 
         [0027]    The system has one or more tray assemblies each with a plurality of bins to hold biological fluid containers. Since many biological fluids required control temperatures, it is assumed that these tray assemblies are mounted in either a refrigerator or warmer as required to maintain proper storage temperature of the biological fluids. For exemplary purposes, an embodiment directed towards biological fluid containers that are blood product containers, typically blood bags, and the tray assemblies are on shelves or in drawers within a biological fluid storage refrigerator such as a hospital storage refrigerator. Other configurations, such as platelet bags in a warmer unit are functionally equivalent. 
         [0028]      FIG. 1  illustrates an example of a tray assembly system  10  which contains a plurality of biologic fluid containers  20 , here dimensioned for use with biological fluid containers  20  provided as standardized blood bags. In this embodiment the tray assembly  10  consists of two major components: a tray base  40  with a tray insert  30  which forms the individual bins used to hold the biologic fluid containers  20 . 
         [0029]      FIG. 2  illustrates multiple tray assemblies  10  mounted in drawers  110  within a typical biologic fluid storage refrigerator  100 . In this embodiment the biologic fluid storage refrigerator  100  consists of a plurality of drawers  110  into which tray assemblies  10  are mounted. In other typical refrigerator  100  embodiments, the tray assemblies  10  may be set on shelves which may or may not pull out for access. A typical implementation would encompass multiple tray assemblies  10 , one for each pull-out drawer or each fixed or pull-out shelf of the biologic fluid storage refrigerator  100 . The biologic fluid storage refrigerator  100  may have a closable refrigerator door  130  (best shown in  FIG. 8 ). 
         [0030]      FIG. 3  shows a tray insert  30 , which may be, for example, injection molded, although other methods of fabrication including 3D printing may be utilized which produce a functional equivalent. The tray insert  30  is built with a plurality of lateral separators  220  and a plurality of lineal separators  230  in orthogonal directions to form a plurality of bins  210 .  FIG. 4  shows the same tray insert  30  from above. Note that the lateral separators  220  have one straight surface and one surface preferably at an angle to the vertical so that the blood bags in each bin will lie flat against the angled surface. In the preferred embodiment, below elevation  270  which is even with the top of drawer  110  as shown in  FIG. 2 , the tray assembly  10  sits within drawer  110 , and only the portion of tray assembly  10  is exposed above drawer  110 , as may be seen in  FIG. 2 . 
         [0031]    Although not shown, each of the bins  210  has an RFID bin antenna assembly  240  mounted on one wall next to the blood bag, typically on the rear angled bin wall against which the blood bag lies. In this manner a nearly constant distance is maintained between each bin antenna assembly  240  and the RFID tag  330  on the blood bag. To prevent a bin antenna assembly  240  from communicating with the blood bag behind it, a metal shield or ferrite patch may be placed behind the RFID antenna circuits as part of the bin antenna assembly  240  to direct signals only forward to the blood bag with the bin in which it is in contact. 
         [0032]    Although not shown explicitly in these drawings, the separators  220  and  230  may be hollow to permit bin antenna assembly wiring and bin status indicator display wiring (or alternatively, fiber-optic light pipes) to be connected to each bin  210  from the hollow circuitry area  250  behind the rear lateral separator. An example of operator visual feedback appears as status indicator display  260  in both  FIG. 3  and  FIG. 4 . The circuitry area  250  contains the RFID antenna multiplexers and RFID reader boards; the tray controller, and in the preferred embodiment wireless communications to a master antenna located inside the refrigerator rather than wired communications. Any wireless connection technique including but not limited to Wi-Fi, Bluetooth or ZigBee may be employed. The tray controller utilizes this wired or wireless connection for two-way communications either directly or over a local area network to the fluid management computer  500 . 
         [0033]      FIG. 5  shows a typical 13.56 MHz (HF) RFID tag  330  mounted on a blood product container  310 . The preferred embodiment utilizes standard ISO 15693 or ISO 18000-3 mode 1 RFID tags operating at 13.56 MHz on the blood bag as part of the iTRACE™ RFID system for blood product identification. The iTRACE™ system was developed at the BloodCenter of Wisconsin and approved for use in the United States under an FDA 510(k). In iTRACE, an RFID tag is used to augment the barcode labeling by storing the same key data structures in the tag which are on placed the bag during final labeling in the form of, for example, International Society for Blood Transfusion ISBT 128 barcodes. 
         [0034]    In an FDA-approved iTRACE RFID tagging system, an ISBT 128 Donation Identification Number (DIN) barcode label  320  is typically taken from a pre-printed label set  310  and placed in the upper left-hand corner of the base label  340  on blood bag  310 . An RFID label is typically placed above it on the blood bag, and typically the DIN barcode label is then read and it&#39;s DIN written into the RFID tag. 
         [0035]    During final labeling, the key blood bag information is encoded both in the RFID tag and on barcodes on the blood bag label using, for example, ISBT 128 data formats, including at least four pieces of information typically utilized to ensure safe transfusion:
       1) The Donation Identification Number (DIN),   2) The ABO/Rh blood group,   3) The ISBT 128 Product Code and   4) The ISBT 128 Expiration Date (which optionally may include a time of day) of the blood product.       
 
         [0040]    Other types of bar codes, RFID tags and RFID tag data encoding formats alternately may be used, depending, for example, upon the government regulatory restrictions in the country of use. 
         [0041]      FIG. 6  shows a block diagram of the electronics and data processing system utilized within and attached to each tray assembly. Each bin  210  corresponding to tray insert  30  on the tray assembly  10  is comprises a specific bin status indicator display  260  and a specific bin antenna assembly  240 . A plurality of bin antenna assemblies  210  may be connected using antenna connections  410  to one or more optional antenna multiplexer  430  which is connected using reader-multiplexer connection  420  to an RFID reader(s)  440 . Alternatively, a bin antenna assembly  240  may be connected directly to its own RFID reader  440 . Each RFID reader  440  is connected by a reader-controller connection  470  to the tray controller  460 . The tray controller  460  is also connected via bin status display connections  450  to the bin status indicator displays  260 . In its simplest form, bin status indicator display  260  comprises a number of colored indicators whose selection and interpretation may be applied, for example, as described below. Alternate forms of bin status indicator displays  260  including graphical, icon or text displays are equivalent embodiments. 
         [0042]    Tray controller  460  is bidirectionally connected to fluid management computer  500  utilizing one or more communications technologies  480  including a direct wired connection; a peer-to-peer wireless connection technology which includes but is not limited to Bluetooth or ZigBee as examples; or a wireless or wired local area network. Wireless communication between the tray controllers and the fluid management computer system may be enabled through use of repeater antennas mounted inside the refrigerator which are externally connected to the antenna of an external wired or wireless communications system. 
         [0043]    The fluid management computer  500  and its operator interface  530  and optional barcode reader  540 , are typically located near the biologic fluid storage refrigerator  100 . The fluid management computer  500  may be standalone or optionally connected to an information system  520 , such as a hospital communications network, over a communications path  510  which is typically a wired or wireless local area network. 
         [0044]      FIG. 7  is a rear view of tray insert  30 . The contents of hollow circuitry area  250  are show below elevation  270 , comprising electronics  610  connected to a rechargeable battery system which comprises rechargeable battery  630  and charging control electronics  640 . Electronics  610 , which may be a single package or a series of components distributed throughout tray insert  30 , comprises tray controller  460 , RFID reader(s)  440  and antenna multiplexer(s)  430 , and their antenna connections  410  to the bin RFID antennas  240 , reader-multiplexer connections  420  between the antenna multiplexers(s)  430  and RFID reader(s)  440 , reader-controller connection(s)  470 , and bin status display connections  450  to the bin status indicators  260 . 
         [0045]    Electronics  610  may be directly powered through a direct wired connection to an external power source. In the preferred embodiment, a wireless power connection to the tray assemblies  10  is enabled when each tray assembly  10  is battery powered using rechargeable battery system comprising rechargeable battery  630  and charging control electronics  640 . The charging control electronics  640  is connected to at least one tray induction coil  650 , which typically mounts on the tray insert  30  above elevation  270 , above the lip of drawer  100 . 
         [0046]    When the drawer  110  is closed, a refrigerator induction coil or a plurality of coils  710  as shown in  FIG. 8  mounted on the interior refrigerator wall  700  of biological fluid storage may be closely aligned with the tray induction coil or coils  650  of the tray assembly  10  in said drawer  110 , for inductive power coupling between the tray assembly  10  and the refrigerator wall  700 . To maximize RF power transfer, it is preferred that both refrigerator induction coils  710  and tray inductions coil  650  are both resonant at the RF excitation frequency of the induction power exciter  720 . Power is transferred from induction power exciter  720  through refrigerator induction coils  710  to tray induction coils  650  and there through to the charging control electronics  640  to enable recharging of the rechargeable battery  630  in tray assemblies  10 . This allows wireless electrical powering of the battery-operated tray assemblies  10 . 
         [0047]    The system operation will now be discussed. Biological fluid containers  20  (here Blood bags  310 ) with encoded RFID tags  330  may be placed into any available bin  210  in a tray assembly  10  in the biologic fluid refrigerator  100 . When blood does not come to the hospital from the blood processing center with preinstalled and/or pre-encoded RFID tags  330 , the system described herein has the capability at the operator interface  530  of the fluid management computer  500  for an operator to place an RFID tag  330  directly on the blood bag  310 , read the blood bag ISBT 128 barcodes on the blood bag using barcode reader  540  and encode an RFID tag  330  on the blood bag  310 . RFID tag data format may be according to standardized systems such as that used in iTRACE™ in the blood processing centers. 
         [0048]    When the refrigerator  120  door of the biologic storage refrigerator  100  is shut, such may be sensed by the fluid management computer  500  using door sensor  550 , and preset business rules may be executed and/or evaluated. For example, a cycle may be initiated to scan all bins  210  of all tray assemblies  10  in the biologic storage refrigerator  100  to determine any changes made to the biologic storage refrigerator  100  contents. Empty bins  210  may be identified, and information from the RFID tags  330  of all populated bins  210  automatically read and entered into an inventory database on the fluid management computer  500  to reflect the current fluid storage refrigerator  100  contents. Any outdated blood units  310  may be identified on the operator interface  530  for removal by the operator. 
         [0049]    Further, when a patient transfusion order is received at the fluid management computer operator interface  530 , it may be entered either as an electronic record transmitted directly by the hospital information network or by the operator manually and/or locally scanned from paperwork. 
         [0050]    Optionally, if for this transfusion request, specific cross matching beyond ABO/Rh is required, messages may be exchanged with the hospital information network to determine if the specific blood bags in that local biologic storage refrigerator  100  inventory have an acceptable cross-match. 
         [0051]    One or more blood bags  310  of the matching blood type may be found in the biologic storage refrigerator  100  inventory. Default blood selection by Expiration Data is the oldest unit of that type; however, in special situations such as transplant surgery or dire medical conditions the freshest unit of that type may be alternatively selected. When a unit of the matching blood type cannot be found, and when permitted by the prescribing physician, compatible units may be suggested for operator selection. For example, AB-blood type is very rare; compatible types A−, B− or O− may be available and when permitted are displayed for operator selection. 
         [0052]    An error message may be generated at the operator interface  530  when sufficient blood of the correct type is not available in the biologic fluid storage refrigerator  100 . A message may also be optionally sent to the hospital information network to request immediate delivery of the needed blood type from the hospital or an external blood bank. 
         [0053]    The operator final selection and blood bag assignment process and transfusion order may each be recorded as a database transaction. The operator interface  530  tells the operator in which refrigerator drawer to look in for the assigned blood bag  310 . The bin status indicator display  260  for each bin  210  will be set to red except for the bin  210  containing the assigned blood bag, which is indicated in green. The RFID system is now activated. The operator takes the assigned blood bag from that bin  210 , and the RFID system verifies that the assigned bin  210  is now empty. An alarm may sound, for example, if blood has been taken from the wrong bin  210  or additional unassigned products are removed. 
         [0054]    The blood inventory database with its now-attached transfusion and selection data record is now updated. An optional request may also be communicated to the hospital blood bank for replenishment of the refrigerator, especially for critical emergency use blood types such as type O Rh negative. 
         [0055]    To enable a check at the patient bedside of a 3-way match of the patient ID number, transfusion order number and key blood bag ISBT 128 data of the assigned units, one of two optional methods may now be employed. The first optional method consists of writing specific patient-related and/or transfusion order information to the RFID tag on said selected blood product container(s) for offline bedside verification. The second method requires that the fluid management computer send the complete blood unit assignment transaction record for the assigned bags to enable hospital information system-driven bedside verification. 
         [0056]    Many modifications to and other embodiments of the invention set forth herein will come to mind to one skilled in the art to which these inventions pertain, once having the benefit of the teachings in the foregoing descriptions and associated drawings. Therefore it is understood that the inventions are not limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be include within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purpose of limitation.