WO2018093706A1 - Système de prévention de la fraude en matière d'utilisation d'articles médicaux - Google Patents

Système de prévention de la fraude en matière d'utilisation d'articles médicaux Download PDF

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Publication number
WO2018093706A1
WO2018093706A1 PCT/US2017/061243 US2017061243W WO2018093706A1 WO 2018093706 A1 WO2018093706 A1 WO 2018093706A1 US 2017061243 W US2017061243 W US 2017061243W WO 2018093706 A1 WO2018093706 A1 WO 2018093706A1
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WO
WIPO (PCT)
Prior art keywords
medical
item
unique identification
items
rfid
Prior art date
Application number
PCT/US2017/061243
Other languages
English (en)
Inventor
Brian Debusk
Joe L. SMITH
Mary E. KAYLOR
Michael R. MCBEE
Original Assignee
Deroyal Industries, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Deroyal Industries, Inc. filed Critical Deroyal Industries, Inc.
Publication of WO2018093706A1 publication Critical patent/WO2018093706A1/fr

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Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/083—Shipping
    • G06Q10/0833—Tracking
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063—Operations research, analysis or management
    • G06Q10/0631—Resource planning, allocation, distributing or scheduling for enterprises or organisations
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/087—Inventory or stock management, e.g. order filling, procurement or balancing against orders
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Definitions

  • This invention relates to the field of medical item inventory management. More particularly, this invention relates to a system for detecting fraud in the reporting of usage of medial items in the treatment of medical patients.
  • the Food and Drug Administration has established a unique device identification (UDI) system to accurately identify medical devices through the course of their distribution and use.
  • UDI device identification
  • the FDA aims to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.
  • a UDI is a unique numeric or alphanumeric code that consists of two parts: a device identifier (DI) and a production identifier (PI).
  • DI is a mandatory fixed portion of a UDI that identifies the device labeler and the specific version or model of a device.
  • a PI is a conditional, variable portion of a UDI that contains item-specific information, such as the lot or batch number within which a device was manufactured, the serial number and expiration date of a specific device, and the date that a specific device was manufactured.
  • Each UDI is provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology.
  • AIDC technology is any technology that conveys the UDI or the DI of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.
  • the PI contains only a lot or batch number. If twenty products having the same DI (e.g. 2.4 mm locking screws or disposable scalpels) are manufactured in the same lot/batch, all twenty products will have the same lot/batch number. If the PI includes only a lot or batch number, it is not possible to differentiate between specific individual devices within the same lot/batch.
  • DI e.g. 2.4 mm locking screws or disposable scalpels
  • GUIDID Global Unique Device Identification Database
  • the current version of the GUDID is comparable to an online phone book. It allows a user to search for a particular DI and download limited device identification information, which may include characteristics of the product, such as whether it contains latex.
  • registration of a product in the GUDID is a one-time event, and the submitted device information does not include PI information.
  • dozens of production lots that include potentially millions of products can be manufactured with no update to the GUDID. These millions of medical devices are distributed into the medical care system with no unique device identification that would allow for effective tracking of specific devices.
  • Embodiments of the invention described herein provide for truly unique device identification to facilitate effective device tracking, thereby enabling detection and reduction of Medicare fraud committed by medical providers and suppliers.
  • RFID Radio Frequency Identification
  • each item pulled for use during a particular medical procedure in accordance with the Bill of Materials (BOM) for the procedure includes an RFID tag affixed to the item or the item's outer packaging.
  • These RFID tags contain appropriate inventory information regarding each item as maintained in the inventory control system and the Operating Room Information System (ORIS).
  • ORIS Operating Room Information System
  • Each individual item that might be used can be tracked through use of the RFID tags and appropriate RFID reader technology.
  • each Operating Room (OR) or other procedure room has a shielded enclosure with multiple RFID antennas disposed inside.
  • a waste bin or receptacle is disposed in the shielded enclosure.
  • This shielded enclosure and an RFID reader connected to the antennas may be conveniently located near the location where the sterile medical supplies are typically opened by the circulating nurse or other OR personnel responsible for setting up the OR for each procedure, such as near the OR back table.
  • the RFID reader is preferably configured so as to only sense RFID tags that are inside the enclosure and not to sense RFID tags outside the enclosure.
  • Some preferred embodiments include a portal containing multiple RFID antennas connected to an RFID reader for reading RFID tags on medial items that are passed through the portal.
  • the RFID reader connected to the portal antennas is preferably configured so as to only sense RFID tags that are inside the portal and not to sense RFID tags outside the portal.
  • the portal is also conveniently located near the location where the sterile medical supplies are typically opened by the circulating nurse or other personnel responsible for setting up the room for each procedure.
  • the portal may also be located in areas where supplies are stored outside the procedure room and at other transition locations in the medical facility.
  • the packaging of a medical supply is opened, that item is considered “consumed” because the packaging has been compromised and it cannot be re-stocked.
  • the packaging is dropped into the shielded enclosure and the reader reads the RFID tags on that packaging.
  • the RFID reader is connected to a data collection interface, such as an ORIS computer terminal, a tablet computer or smart phone, and the consumption information for each item is logged.
  • This system provides an accurate way to track supply utilization that does not require additional data input steps from the OR personnel. Simply throwing the discarded packaging into a waste container, which is normal procedure, allows for the RFID tagged supplies to be registered as consumed.
  • a stock bin is provided. Prior to performance of a medical procedure, all RFTD-tagged medical supply items that were pulled from the supply room or supply cabinet are placed in the stock bin, the stock bin is moved through the portal or is placed inside the shielded enclosure, and the RFID reader reads the data from the RFID tags on the packaging. In this manner, pre-op data regarding items pulled for use according to a particular BOM can be captured for a given case.
  • the RFID reader reads the data from the RFID tags on the packaging.
  • post-op data regarding both consumption and non-consumption relative to a given BOM can be captured for a given case.
  • the RFID reader is connected through a data interface into the ORIS system or the inventory management system and the data regarding the non-consumed items are captured. The process preferably associates medical items (and/or their manufacturer's lot number) and instrument trays to specific patients in the event of a recall or negative occurrence that is determined post-case.
  • the data can be very useful in myriad ways. Since consumption data is accurately determined through the sensing of packaging in the waste bin, billing for medical items consumed in the case can be more accurately reflected on the patient's bill, thereby allowing the hospital to more accurately charge for the procedure. If the stock bin option is included, this ensures that items pulled for the procedure that were detected in the pre-op scan but were not consumed during the procedure are properly returned to inventory. This process also digitally tracks the movement of each item through various transition locations in the medical facility. This makes it possible to identify excessive handling of items and potential exposures to infectious patients.
  • a database is provided (also referred to herein as the UDI Serialized Tracking Database) that complements the FDA's Global Unique Device Identification Database (GUDID).
  • GUIDID Global Unique Device Identification Database
  • manufacturers register the lot and preferably the serial number information for each individual item in the UDI Serialized Tracking Database. More importantly, each individual item registered in the UDI Serialized Tracking Database is assigned a unique identification number encoded in an Electronic Product Code (EPC) in a Radio Frequency Identification (RFID) tag attached to the item.
  • EPC Electronic Product Code
  • RFID Radio Frequency Identification
  • the UDI Serialized Tracking Database maps the unique number to the item's UDI. As each item is consumed during medical treatment and billed to payers, the unique identification number encoded in the EPC of the device is verified and reported.
  • One preferred embodiment is directed to an apparatus for recording consumption of medical items used during performance of a medical procedure in a medical facility and for detecting fraud in reporting the consumption of the medial items.
  • the medical items are at least initially enclosed in wrappers having RFID tags disposed in or on the wrappers.
  • a unique identification number that uniquely identifies an individual medical item is encoded in each of the RFID tags.
  • the apparatus preferably includes a shielded enclosure having an internal space for receiving the wrappers of the medical items, RFID antennas disposed within the shielded enclosure, an RFID reader that is electrically connected to the RFID antennas, and a database in which unique identification numbers encoded in RFID tags are cross referenced to Unique Device Identifier (UDI) numbers assigned by a governmental agency to identify specific types of medical items used in medical procedures.
  • a computer is in communication with the database.
  • the shielded enclosure is configured to attenuate radio frequency signals emanated from RFID tags disposed outside the shielded enclosure to levels that are substantially undetectable within the internal space.
  • the RFID antennas receive radio frequency signals emanated from the RFID tags attached to the wrappers disposed within the internal space.
  • the radio frequency signals contain the unique identification numbers encoded in the RFID tags.
  • the RFID reader decodes the unique identification numbers contained in the radio frequency signals emanated from the RFID tags.
  • the computer has a processor that executes instructions for:
  • any unique identification number decoded by the RFID reader is not valid for the UDI number assigned to identify the specific type of medical item, or
  • the computer is disposed in the medical facility, the computer is in electrical communication with the RFID reader, and the computer executes the instructions for accessing the database and generating a fraud alert message automatically upon receipt of the unique identification numbers decoded by the RFID reader.
  • the computer is associated with a medical bill payer entity that receives a bill listing the unique identification numbers decoded by the RFID reader, and the computer executes the instructions for accessing the database and generating a fraud alert message upon entry into the computer of the unique identification numbers listed in the bill.
  • embodiments are directed to a method for recording consumption of medical items used during performance of a medical procedure and for detecting fraud in reporting the consumption of the medial items.
  • the medical items are at least initially enclosed in wrappers having RFID tags disposed in or on the wrappers.
  • a unique identification number that uniquely identifies an individual medical item is encoded in each of the RFID tags.
  • a preferred embodiment of the method includes the following steps:
  • any unique identification number decoded from the radio frequency signals is not valid for the UDI number assigned to identify the specific type of medical item, or
  • any unique identification number decoded from the radio frequency signals was previously logged into the database in association with a medical item that was previously consumed in medical treatment of a patient.
  • steps (e), (f) and (g) are performed by a computer that is disposed in the medical facility and is in electrical communication with the RFID reader. In these embodiments, steps (e), (f) and (g) are performed automatically upon completion of step (d).
  • steps (e), (f) and (g) of the method are performed by a computer that is associated with a medical bill payer entity that receives a bill listing the unique identification numbers decoded by the RFID reader.
  • steps (e), (f) and (g) are performed upon entry into the computer of the unique identification numbers listed in the bill.
  • FIG. 1 depicts a system for sensing and recording consumption of medical items during a medical procedure according to an embodiment of the invention
  • FIGS. 2A and 2B depict shielded enclosures according to embodiments of the invention.
  • FIG. 3 depicts a method for sensing and recording consumption of medical items during a medical procedure according to an embodiment of the invention
  • FIGS. 4A - 4F depict a portal according to an embodiment of the invention
  • FIGS. 5 and 6 depict processes for sensing and recording utilization of medical resources in the performance of a medical procedure in a medical facility according to embodiments of the invention
  • FIGS. 7 and 8 depict processes for generating alerts based on utilization of medical resources in the performance of a medical procedure in a medical facility according to embodiments of the invention
  • FIGS. 9-11 depict a system for tracking medical items through various transition points in a supply and consumption chain according to an embodiment of the invention
  • FIG. 12 depicts an apparatus for maintaining an inventory of medical items according to an embodiment of the invention
  • FIG. 13 depicts a computer system associated with a supply room door according to an embodiment of the invention
  • FIG. 14 depicts a system for detecting fraud in the reporting of usage of medial items in the treatment of medical patients according to an embodiment of the invention.
  • FIG. 15 depicts a method for detecting fraud in the reporting of usage of medial items in the treatment of medical patients according to an embodiment of the invention.
  • a "medical item” is an item, material, substance, or piece of durable medical equipment (DME) that is used or consumed during the performance of a medical procedure or that is dispensed to a patient to treat a medical condition or provide comfort to the patient.
  • DME durable medical equipment
  • a surgical implant is another example of a medical item. Knee braces, negative pressure wound therapy units, blood glucose monitors, and wheelchairs are further examples of medical items.
  • Medical items comprise a subset of "medical resources.”
  • a "medical resource” is any item, person, piece of equipment, or space involved in providing medical services for a patient. For example, a gurney on which a patient lies during a surgical procedure is a medical resource. The doctor performing the procedure, the attending nurses, and the patient are also medical resources. An operating room is a medical resource.
  • a “wrapper” encompasses all manner of containers and packaging, sterile or non-sterile, in which a medical item is or has been enclosed.
  • the term “wrapper” also includes a label, hang tag, or other such device that may be attached to a medical item without completely enclosing the item.
  • the term “wrapper” further includes packaging for a sterile-wrapped kit of medical items, such as a tray of implants and supplies for use in a surgical procedure, wherein an RFID tag is attached to the tray.
  • anything that may function to associate an RFID tag with a medical item is encompassed by the term "wrapper.”
  • Each medical item has a unique item identifier encoded in a machine-readable code in an RFID tag, a QR code, a bar code, or a combination thereof attached to the medical item or its wrapper.
  • an RFID tag and a QR code are combined in a single label applied to the medical item or its wrapper.
  • each wrapper includes an RFID tag attached thereto or embedded therein.
  • Ultra-High Frequency (UHF) passive RFID tags are preferred for this application, as they may be interrogated from up to about 30 centimeters away.
  • each RFID tag is encoded with a unique item identification number for the particular medical item associated with the wrapper.
  • An item information database 52 associates each item identification number with item-specific information, such as the manufacturer part number, item description, vendor, cost, Latex content, expiration date, and inventory location. Additionally or alternatively, the RFID tag may be encoded with item-specific information as set forth in Unique Device Identification (UDI) standards set by the U.S. Food and Drug Administration (FDA).
  • UFI Unique Device Identification
  • item-specific information encoded in RFID tags on medical items may be used to generate alerts for medical personnel. For example, an alert may be generated if information encoded in an RFID tag indicates the presence of Latex in an item, and the patient is allergic to Latex. Also, an alert may be generated if information encoded in an RFID tag indicates that an item's useful lifetime has expired or if the item is from a lot that has been recalled by the manufacturer.
  • a "portal" is any passageway, opening, aperture, window, panel, wall, doorway, hallway, pathway, or aisle in or near which one or more RFID antennas are mounted for sensing RFID tags that pass through or near the portal.
  • a portal may also be a handheld scanning device for reading RFID tags. Several portals may be used to track the routes of travel and locations of medical resources throughout a medical facility or a medical item supplier facility.
  • a "scan" for RFID tags refers to operations performed by an RFID reader to transmit signals and receive signals from RFID tags that are in range of the RFID reader and its associated antenna(s).
  • portals are placed at "transition locations" within a medical facility or a medical item supplier facility.
  • transition locations include supply rooms, supply cabinets, procedure rooms, waste containers, personnel break rooms, hallways, shipment assembly areas, shipment loading docks, and points of entry into and exit from the medical facility or a medical item supplier facility.
  • a "shipment" of medical items comprises multiple medical items, of the same type or different types, that are packaged together at a supplier location and shipped to a location at which the medical items are consumed or dispensed.
  • each shipment includes a packing list that lists all of the medical items in the shipment.
  • each packing list has a unique shipment identifier that encodes shipment identification information that is specific to the shipment.
  • the shipment identifier may be in the form of an RFID tag, bar code, or other encoded identifier attached to, embedded in, or printed on the packing list.
  • a system 10 for sensing and logging consumption of medical items during a medical procedure includes a shielded enclosure 12 having a space 16 that is preferably large enough to receive a waste bin 18.
  • two RFID antennas 14a and 14b Disposed within the enclosure 12 are two RFID antennas 14a and 14b, such as Laird 5 x 5 inch Mini Far Field antennas (model number S9025PL F) having left-hand circular polarization and operating in the 902-928 MHz frequency range.
  • One of the antennas 14a is preferably disposed at the top of the enclosure 12, with its field of view looking downward into the space 16.
  • the other RFID antenna 14b is preferably disposed at the bottom of the enclosure 12, with its field of view looking upward into the space 16.
  • the RFID antennas 14a- 14b are electrically connected, such as via a coaxial cable, to a UHF RFID tag reader 28.
  • the RFID tag reader 28 is an Impinj® Speedway® model R420.
  • FIGS. 2 A and 2B Preferred embodiments of the shielded enclosure 12 are shown in FIGS. 2 A and 2B, wherein the sidewalls are depicted as transparent.
  • the enclosure 12 is preferably made from 0.080 inch thick sheet aluminum supported by 0.75 x 0.75 inch square aluminum tubing (0.125 thick).
  • the outside dimensions of the preferred embodiment are 23.5 x 22.0 x 40.75 inches.
  • shielded means that the enclosure 12 is designed to prevent the antennas 14a- 14b from receiving RFID signals from RFID tags located outside the enclosure 12 at a signal-to-noise ratio high enough to trigger detection of those outside RFID tags.
  • shielded does not mean that absolutely all RF energy is blocked from entering the enclosure, as this would require unnecessary levels of shielding.
  • an opening 24 is provided in the top of the enclosure that is large enough to receive wrappers or containers 20 from which medical items have been removed.
  • the opening 24 is preferably a 6.75 x 13.75 inch rectangle.
  • An aluminum cover 25 is provided over the opening 24.
  • the cover may be slanted as shown in FIG. 2A or more box -like as shown in FIG. 2B to prevent signals from escaping the enclosure 12.
  • the enclosure preferably includes an aluminum chute 23 around the opening 24, and an aluminum shield 27 around the antenna 14a.
  • the waste bin 18 is positioned below the opening 24 so that wrappers 20 deposited in the opening 24 fall into the bin 18.
  • a hinged door 26 large enough to receive the waste bin 18 is provided in a sidewall of the enclosure 12.
  • the door 26 is preferably 29.5 x 39.25 inch, and includes a handle/latch for securing the door in a closed position.
  • the enclosure 12 is considered to be shielded when the door 26 is closed.
  • the system 10 includes a portal 48 having an opening 49 at least large enough to receive the waste bin 18.
  • the portal 48 is preferably equipped with four RFID antennas 50a-50d having fields of view looking inward into the portal opening 49.
  • the RFID antennas 50a-50d are electrically connected, such as via coaxial cables, to a UHF RFID tag reader 46.
  • the RFID tag reader 46 is an Impinj® Speedway® model R220.
  • the tag reader 46 and the tag reader 28 comprise a single tag reader.
  • the waste bin 18, also referred to herein as a waste tote, is preferably a plastic container having an open top for receiving wrappers 20.
  • an RFID tag 22 encoded with a unique bin identification number is attached to the waste bin 18.
  • the database 52 associates the bin identification number with a particular procedure room to which the waste bin 18 is assigned.
  • the RFID tag 22 may be encoded with information indicating the procedure room to which the bin 18 is assigned.
  • the RFID tag readers 28 and 46 are electrically connected via a local area network (LAN) 42 to a medical item inventory computer 31, which may be a server computer, desktop computer, laptop computer, tablet computer or other mobile computing device. Alternatively, the electrical connection between the RFID tag readers 28 and 46 and the computer 31 is via a Universal Serial Bus (USB) interface.
  • the computer 31 includes memory for storing and a processor for executing instructions of a medical item inventory module 40.
  • the medical item inventory module 40 compiles pre-op and post-op lists of items, compares the lists to detect discrepancies, generates alert messages upon detection of discrepancies, and updates inventory records based on actual item usage.
  • an Operating Room Information System (ORIS) computer 30 is in communication with the medical item inventory computer 31 via a communication network, such as the LAN 42.
  • the ORIS computer 30 is also in communication with a hospital computer system 32 via a communication network, such as the LAN 42.
  • the hospital computer system 32 manages medical item inventories, operating room scheduling, patient records, insurance reimbursement/payment functions, and admission/discharge/transfer (ADT) records.
  • the hospital computer system 32 may also include or be connected to an electronic data interchange server, such as a J.D. Edwards/Oracle server, that implements electronic commerce transactions between the hospital and medical item suppliers.
  • the medical item inventory module 40 is a software application running on the computer 31. In alternative embodiments, the medical item inventory module 40 is executed by a remote computer (outside the OR). For example, the medical item inventory module 40 may be implemented as "software-as-a-service" provided via the Internet by a medical item inventory service provider.
  • a preferred embodiment of the system 10 includes a stock bin 34, which may also be referred to herein as a transport bin or stock tote.
  • the stock bin 34 is used to transfer medical items 38 to be used during a medical procedure from a stock room to the procedure room, and to transfer unused medical items 38 from the procedure room back to the stock room.
  • an RFID tag 36 is attached to the stock bin 34 that is encoded with a unique bin identification number.
  • the database 52 associates the bin identification number with a particular procedure room or stock room to which the stock bin 34 is assigned.
  • the RFID tag 36 may be encoded with information indicating the procedure room or stock room to which the stock bin 34 is assigned.
  • FIG. 3 depicts a preferred embodiment of a process 100 for sensing and recording consumption of medical items during a medical procedure using the system depicted in FIG. 1.
  • hospital personnel pick medical items from inventory stock to be used during the medical procedure (step 102 in FIG. 3).
  • the needed items may be listed on a Bill of Materials (BOM) for the particular type of procedure to be performed.
  • BOM Bill of Materials
  • the BOM also reflects the individual preferences of particular doctors.
  • These types of BOM' s may also be referred to as Doctor Preference Cards.
  • the picked items are placed in the stock bin 34 to be transferred to the OR.
  • the stock bin 34 containing the picked items 38 is placed in or passed through the portal 48 outside the procedure room (step 104) and the RFID reader 46 reads the RFID tags on the wrappers of the items 38 in the stock bin 34 (step 106).
  • activation of the reader 28 is triggered manually by a person in the procedure room using an interface device (mouse, touchpad or keyboard) of the computer 31.
  • the item identification numbers read from the RFID tags in the portal 48 are transferred to the medical item inventory computer 31 where the medical item inventory module 40 compiles a pre-op list of the items 38 in the stock bin 34 (step 108).
  • the date/time of the compilation of the list is recorded in the medical item inventory computer 31, along with the identification number of the stock bin 34.
  • Other information may be associated with the pre- op list, such as procedure room number, doctor name, patient name, patient age, patient weight, patient allergies, type of medical procedure, and case number.
  • Steps 104-110 of FIG. 3 are optional and are not implemented in all embodiments of process 100. If these steps are not performed, the BOM for the medical procedure may serve the purpose of the pre-op item list.
  • the items 38 are preferably removed from the bin 34 and arranged on a table in the procedure room according to the doctor's or attending nurse's preference.
  • wrappers 20 removed from the items 38 are dropped through the opening 24 in the enclosure 12 where they are received into the waste bin 18 (step 114).
  • the RFID tags on the wrappers 20 are detected and read by the reader 28 (step 116). It will be appreciated that a waste bin 18 is not absolutely necessary for this process. However, the use of a waste bin 18 makes collection and removal of the wrappers 20 easier.
  • the item identification numbers read from the RFID tags in the enclosure 12 are transferred to the medical item inventory computer 31 where the medical item inventory module 40 compiles a post-op used-item list of the wrappers 20 (step 1 18).
  • the date/time that each wrapper 20 was first detected is recorded in the list.
  • the identification number of the waste bin 18 (if any) and other information may be associated with the post-op used-item list, such as procedure room number, doctor name, patient name, type of medical procedure, and case number.
  • the waste bin 18 remains outside the shielded enclosure 12 during the procedure.
  • wrappers 20 removed from the items 38 are deposited in the waste bin 18.
  • the waste bin 18 containing the wrappers 20 is placed through the portal 48 (step 114), and the reader 28 reads the RFID tags of the wrappers 20 (step 116).
  • the post-op used-item list is compiled as described in the previous embodiment (step 118).
  • all unused items 38 are placed back into the stock bin 34, and the stock bin 34 is passed through the portal 48 (step 122).
  • the reader 46 reads the RFID tags of the unused items 38 (step 124), and a post-op unused-item list is compiled (step 126).
  • the identification number of the stock bin 34 and other information may be associated with the post-op unused-item list, such as procedure room number, doctor name, patient name, type of medical procedure, and case number.
  • Steps 122-126 of FIG. 3 are optional and are not implemented in all embodiments of process 100. If these steps are not performed, the post-op unused-item list may be generated by comparing the BOM to the post-op used item list.
  • the medical item inventory module 40 may compare the items listed in the pre-op list to the items listed in the post-op used- item list and the post-op unused-item list (step 128). If an item in the pre-op list does not appear on either of the post-op lists (step 130), this means the item was brought into the procedure room but neither the item nor its wrapper ended up in the stock bin or the waste bin after the procedure. In this case, an alert is generated that causes a message to appear on a display screen of the ORIS computer 30 or the medical item inventory computer 31 (step 132).
  • the alert should prompt the procedure room personnel to investigate three possibilities that may have caused the discrepancy: (1) the item is unused and still in the procedure room but was inadvertently not placed back into the stock bin before the post-op unused-item list was compiled, (2) the item was used and its wrapper is still in the procedure room but the wrapper was inadvertently not placed in the waste bin before the post-op used-item list was compiled, or (3) the item and/or its empty wrapper was removed from the procedure room prior to compilation of either of the post-op lists. In any event, the missing item(s) or wrapper(s) should be located and the pre-op and post-op lists reconciled (step 134).
  • step 136 If the comparison of the pre-op and post-op item lists indicates that an item that appears on either of the post-op lists is not on the pre-op list (step 136), this means that the item or its wrapper was present in the procedure room when the post-op lists were compiled, but it was (1) not brought into the procedure room in the stock bin with the other items, or (2) brought into the procedure room in the stock bin but was removed from the stock bin prior to compilation of the pre-op list. In this case, an alert is generated which causes a message to appear on a display screen of the computer 31 (step 138). The alert should prompt the procedure room personnel to investigate what may have caused the discrepancy and reconcile the pre-op and post-op lists (step 140).
  • the computer 31, the ORIS computer 30, or the hospital computer system 32 uses the lists to update the database 52 based on actual item usage (step 142).
  • the hospital computer system 32 or the ORIS computer 30 also may use the post-op used-item list to accurately bill the patient (or insurance company) for the items used during the procedure (step 146).
  • the stock bin 34 may be returned to the appropriate inventory stock room where the unused items 38 may be returned to inventory (step 144).
  • the hospital computer system 32 or the Medical Item Inventory Application 40 analyzes the post-op unused-item lists generated during multiple procedures of the same type and for the same doctor to determine trends in the lack of usage of certain medical items that are listed on BOM's (step 146).
  • This trend data may be used to revise the BOM's for certain procedure s/doctors. For example, if the trend data indicates that in 90% of hip replacement surgeries performed by Dr. Jones only three sponges of a particular type are used out of the five called for on the BOM, the BOM may be revised to call for only three sponges.
  • Trend data may also be used to determine the optimal locations to store medical supplies and the optimal quantities to store.
  • FIG. 5 depicts an embodiment of a process 400 for analyzing the utilization of two different medical resources based on sensing (or not sensing) their RFID tags at two different transition locations within a medical facility.
  • the process 400 involves attaching RFID tags to medical resources (step 402), disposing RFID-sensing portals at various transition locations within the medical facility (step 404), reading medical resource information from the RFID tags using the portals (step 406 and 412), and decoding the medical resource information to identify the medical resources (step 408 and 414) and determine various characteristics of the resources as described in more detail below.
  • a first medical resource is detected at a first transition location at a time Tl (step 410) and at a second transition location at a time T2 (step 416). Based on these detections, the system determines that the first medical resource travelled from the first transition location to the second transition location between times Tl and T2 (step 418). Based on this route of travel and the times of detection, the system creates a utilization profile for the first medical resource (step 420).
  • a second medical resource is detected at the first transition location at a time T3 (step 422), which may be less than, greater than, or equal to time Tl .
  • the second medical resource is again detected at the first transition location at a time T4 (step 426), which is occurs after time T3 (T4 > T3).
  • T4 time T3
  • T4 > T3 time T3
  • the system determines that the second medical resource travelled from the first transition location back to the first transition location between times T3 and T4, and did not travel to the second transition location (step 428). Based on this route of travel and the times of detection, the system creates a utilization profile for the second medical resource (step 430).
  • the first transition location may be an entrance/exit door of a medical procedure room PRl within a medical facility
  • the second transition location may be a waste container WC1 within the medical procedure room PRl
  • the first medical resource may be a first medical item that was picked to be used during a medical procedure MPl in the procedure room PRl
  • the second medical resource may be a second medical item that was picked to be used during the same medical procedure MPl in the procedure room PRl .
  • the system determines that the first medical item entered the medical procedure room PRl (first transition location) at time Tl, and it or its wrapper was deposited in the waste container WC1 (second transition location) at time T2.
  • the system Based on this route of travel, the system creates a utilization profile indicating that the first medical item was used or consumed during the medical procedure MP1. Also based on the detections described above, the system determines that the second medical item entered the medical procedure room PRl (first transition location) at time T3, exited the medical procedure room PRl (first transition location) at time T4, and was not deposited in the waste container WC1 (second transition location). Based on this route of travel, the system creates a utilization profile indicating that the second medical item was brought into the medical procedure room PRl, but was not used during the medical procedure MP1.
  • FIG. 6 depicts an embodiment of a process 440 for analyzing the utilization of three different medical resources based on their RFID tags being sensed (or not sensed) at two different transition locations within a medical facility.
  • the process 440 involves reading medical resource information from RFID tags attached to three medical resources - a first medical item, a doctor, and a patient - using portals at the entrance/exit of a procedure room PRl and on a waste container WC1 (step 442 and 448), and decoding the medical resource information to identify the medical resources (step 444 and 450) and determine various characteristics of the resources.
  • the system determines that the first medical item entered the medical procedure room PRl at time Tl, and it or its wrapper was deposited in the waste container WC1 at time T2 (step 454). Based on this route of travel, the system creates a utilization profile indicating that the first medical item was used during the medical procedure MP1 (step 456).
  • the system detects the doctor Dl entering the medical procedure room PRl at time T3 which may be less than, greater than, or equal to time Tl (step 458).
  • the doctor Dl is detected leaving the medical procedure room PRl at time T4 which is greater than Tl and T3 (step 460).
  • the system creates a utilization profile indicating that the doctor Dl was involved in a medical procedure MP1 in the procedure room PRl between times T3 and T4 (step 464).
  • the utilization profile for the doctor Dl indicates that the first medical item was consumed or used during a medical procedure MP1 performed by the doctor Dl.
  • the utilization profile for the first medical item also indicates that the first medical item was consumed or used during a medical procedure MP1 performed by the particular doctor Dl.
  • the system detects the patient PI entering the medical procedure room PRl at time T5 which may be less than, greater than, or equal to time Tl (step 466).
  • the patient PI is detected leaving the medical procedure room PRl at time T6 that is greater than Tl and T5 (step 468).
  • the system creates a utilization profile indicating that the patient PI was involved in a medical procedure MPl in the procedure room PRl between times T5 and T6 (step 470).
  • the utilization profile for the patient PI also indicates that the first medical item was consumed or used during the medical procedure MPl performed on the patient PI by the particular doctor Dl . In some embodiments, the utilization profile for the first medical item also indicates that the first medical item was consumed or used during the medical procedure MPl performed on the particular patient PI . In some embodiments, the utilization profile for the doctor Dl also indicates that the first medical item was consumed or used during the medical procedure MPl performed on the particular patient PI .
  • FIG. 7 depicts a preferred embodiment of a process 480 for generating an alert based on utilization of medical resources in the performance of a medical procedure in a medical facility.
  • This process 480 analyzes the utilization of two different medical resources based on sensing their RFID tags at the same transition location within the medical facility.
  • the process 480 involves reading medical resource information from RFID tags attached to the two medical resources - a first medical item and a patient PI - using portals at the entrance/exit of a procedure room PRl (step 482), and decoding the medical resource information to identify the medical resources (step 484) and to determine various characteristics of the resources.
  • the medical resource information decoded at step 484 may indicate whether the first medical item contains a potential allergenic, such as Latex, and whether the patient PI is allergic to any drugs or substances, such as Latex.
  • the system detects that the first medical item entered the medical procedure room PRl (step 486) at a certain time and that the patient P 1 entered the medical procedure room PRl at a certain time (step 492). If the first medical item contains a substance to which the patient PI is allergic, and the first medical item and the patient PI are in the procedure room PRl simultaneously (steps 488, 494 and 496), the system generates an alert informing personnel in the procedure room PRl of the potential for a harmful allergic reaction (step 498).
  • This alert may be audible (siren) and visible (strobe lights) in the procedure room, and it may be sent via electronic messaging to other personnel within the medical facility to give notice of the situation.
  • the occurrence of such an event is also reflected in the utilization profile of the patient PI .
  • the system generates a potential allergic reaction alert if an RFID reader portal at the doorway of a supply room detects a medical item leaving the supply room that was picked for use during a medical procedure involving a patient that is allergic to a substance in the medical item. This detection could also be made by any RFID reader portal at any transition location between the supply room and the medical procedure room.
  • FIG. 8 depicts a preferred embodiment of another process 500 for generating an alert based on utilization of medical resources in the performance of a medical procedure in a medical facility.
  • This process 500 analyzes the utilization of two different medical resources based on sensing their RFID tags at the same transition location within the medical facility.
  • the process 500 involves reading medical resource information from RFID tags attached to the two medical resources - a first medical item and a patient PI - using portals at the entrance/exit of a procedure room PR1 (step 502), and decoding the medical resource information to identify the medical resources (step 504) and to determine various characteristics of the resources.
  • the medical resource information decoded at step 504 may indicate that the patient P 1 is infected with a highly infectious contagion, such as Methicillin-resistant Staphylococcus aureus (MRSA).
  • MRSA Methicillin-resistant Staphylococcus aureus
  • the system If the first medical item was not deposited in a hazardous waste container prior to leaving the procedure room PR1, and the first medical item and the patient PI were in the procedure room PR1 simultaneously, and the patient PI is infected with a contagion such as MRSA (steps 510, 516, 518), the system generates an alert informing personnel in the procedure room PR1 of a potential for spread of a highly infectious contagion due to possible contact with the first medical item (step 520). This alert may be audible (siren) and visible (strobe lights) in the procedure room, and it may be sent via electronic messaging to other personnel within the medical facility to give notice of the situation. In preferred embodiments, the occurrence of such an event is also reflected in the utilization profile of the first medical item.
  • a contagion such as MRSA
  • the determination that the patient is infected may be made after the procedure is complete and the patient has left the procedure room. In such situations, the system will generate the alert (step 520) after information indicating the patient's infection is entered into the patient's record (the medical resource information for the patient.)
  • FIGS. 9-11 depict a system for tracking medical items through various transition points in a supply and consumption chain.
  • each shipment 54 of medical items 38 includes a packing list 56 that has a unique shipment identifier 58 encoded in an RFID tag and/or a bar code attached to the packing list.
  • a unique item identifier 39 encoded in an RFID tag and/or a bar code attached to each packed medical item 38 and the unique shipment identifier 58 of the accompanying packing list 56 are read by one or more reading devices 59 and are cross-referenced in a supplier inventory database 60.
  • the reading devices 59 may include one or more RFID tag readers and their associated antennas and one or more bar code readers.
  • the one or more reading devices 59 may also read the unique personnel identifier 55 of the person responsible for the shipment of medical items at the supplier facility, which identifier may be encoded in the person's ID badge 57.
  • the unique shipment identifier 58 is also cross-referenced in the supplier inventory database 60 with the unique personnel identifier 55.
  • a "supplier facility" is any location at which the medical items are disposed prior to shipment to the medical facility, such as a manufacturer facility or a distributor facility.
  • the unique shipment identifier 58 of the packing list 56 is read and decoded by one or more reading devices 62, and the unique shipment identifier is stored in the medical facility inventory database 52 in association with a unique personnel identifier 65 of the person responsible for receiving the shipment of medical items at the medical facility.
  • the one or more reading devices 62 may include one or more RFID tag readers and their associated antennas and one or more bar code readers. The one or more reading devices 62 may also read the unique personnel identifier 65 of the person responsible for receiving the shipment of medical items at the medical facility, which identifier may be encoded in the person's ID badge 63.
  • the unique shipment identifier 58 and the unique item identifier 39 on each medical item 38 is read and decoded by one or more reading devices 66, and the unique item identifier 39 of each medical item 38 is stored in association with a unique supply room identifier in the inventory database 52 for the medical facility.
  • the one or more reading devices 66 may include one or more RFID tag readers and their associated antennas and one or more bar code readers.
  • the inventory database 52 also cross-references the unique item identifiers 39 with a unique personnel identifier 69 of the person responsible for placement of the medical items into inventory at the medical facility, which identifier may be encoded in the person's ID badge 67.
  • the unique item identifier 39 on each medical item 38 is read and decoded by a portal reading device 41 in the supply room, and the unique item identifier of each medical item is stored in the inventory database 52 in association with a unique bill of material (BOM) identifier 73 of the BOM 74 for the procedure/exam/test.
  • BOM bill of material
  • the unique item identifiers 39 and BOM identifier 73 is cross-referenced in the database 52 with a unique personnel identifier 75 of the person removing the medical items from the supply room, which identifier may be encoded in the person's ID badge 71. At this point, the medical items may be in a transport bin 34.
  • the unique item identifier 39 on each medical item is read and decoded by a portal reading device 48 in or at the entrance to the procedure/exam/test room, and the unique item identifier of each medical item is stored in the inventory database 52 in association with a unique procedure/exam/test room identifier and a unique personnel identifier 49 of a person accepting delivery in the procedure/exam/test room.
  • the unique personnel identifier 49 may be encoded in the person's ID badge 47.
  • the unique item identifier 39 on the packaging 20 of each used medical item is read and decoded by a reading device 28 associated with the waste bin 18 in the supply room, and the unique item identifier of each medical item is stored in the inventory database 52 in association with a unique patient identifier.
  • the medical items 38 that are not used or consumed during the medical procedure are preferably placed back into the transport bin 34, the transport bin 34 is passed through the portal 48, and the reader 46 reads the RFID tags of the unused items 38.
  • the item identification information encoded in those RFID tags is cross-referenced in the database 52 with a unique personnel identifier of the person removing the unused medical items from the medical procedure room and transporting the items to the supply room for restocking, which identifier may be encoded in the person's ID badge.
  • a prompt may be automatically generated to remind the responsible personnel to scan the unique item identifier 39 on each medical item 38 so that the information will be entered into the inventory database 52, or to remind the responsible personnel to take other action as may be necessary based on the location and status of the medical items 38.
  • These prompts may be visual or audible.
  • the inventory database 52 maintains a chain of custody for each item 38 through each transition point (and for each shipment 54 of items between the first and second transition points) and keeps records of the personnel responsible for each item or shipment at each location at any particular time.
  • individual medical item information may not be specifically recorded, although bulk information associated with the packing list 56 will be recorded.
  • the unique item identifiers 39 may recovered and the unique item identifier information can be automatically associated with the dispensing activity where unique item identifier information was previously not recorded.
  • transition points could consist of any handling point along the supply chain for a medical item from manufacturer to patient.
  • each transition point is defined by the type of location.
  • Each type of location may have a set of characteristics associated with that location type that trigger certain action prompts when the medical items are associated with that particular location type in the database 52.
  • the supply room identification equipment may prompt the inventory management personnel to place the products in the appropriate product storage location, initiate an RFID scan of the room to identify the medical items present in the room and subsequently present information to the inventory management personnel to determine if the room inventory, as updated, reconciles with the packing list.
  • the procedure room computer 30 may generate action prompts based on association of the DME item with the patent. For example, the procedure room computer 30 may prompt the treating personnel to disclose to the patient certain information related to the proper use of the DME item, to input information to verify the delivery of the DME item to the patient, or to obtain the patient's signature to acknowledge receipt of the DME item.
  • DMEPOS Durable Medical Equipment, Prosthetics, Orthotics and Supplies
  • the system may generate a notification to treating personnel that the old/used item should go back to hospital stock and a new item should be dispensed to patient.
  • the exits of the hospital or other medical facility are transition points at which networked RFID tag readers are positioned.
  • the medical item inventory computer 31 triggers a billing change event to cause the billing for the DME item to change from Medicare Part A, in which the medical facility pays for rental, to Medicare Part B, in which the patient or the patient's insurance company is billed for the item.
  • This exit event may also cause the medical item inventory computer 31 to update the chain of custody for the DME item to indicate a transfer of possession from the medical facility to the patient.
  • Such an exit event may also trigger the sending of notifications to the patient and medical personnel regarding follow-up care for patient using the DME item, such as notifications recommending a Part B healthcare provider and prompting the scheduling of follow-up appointments.
  • FIG. 12 depicts a functional block diagram of features of a medical item supply room 68 according to a preferred embodiment.
  • a "storage bin” is any storage structure in or on which medical items may be stored, including but not limited to a container, shelf, drawer, hanger, or cabinet.
  • One or more RFID antennas 72 are directed toward the storage bins 70 to detect RFID tags on medical items 38 stored therein.
  • the antennas 72 are electrically connected to one or more RFID tag readers 66 that are in communication with the medical facility network 42.
  • a supply room computer 64 is provided to allow personnel in the supply room 68 to access medical item inventory information over the network 64.
  • the supply room 68 has RF shielding 76 in the walls, floor and ceiling to prevent detection of RFID tags that are outside the supply room.
  • RFID shielding 76 may also be provided in gaskets around the edges of the door frame and in a door sweep on the bottom of the door.
  • a computer 78 is built into the door 74 of the medical item supply room 68.
  • this computer 78 preferably includes a processor 80, a touch screen display 82, keypad 84, biometric sensor 86 such as a fingerprint reader or retinal scanner, and a code reader 90, such as an RFID reader, barcode reader or magnetic stripe reader, for reading identification information of personnel seeking access to the supply room and decoding the unique personnel identifiers encoded personnel ID badges.
  • the processor 80 interfaces with one or more sensors 85 that sense whether the door 74 is in an open state or a closed state and/or whether the door is locked or unlocked.
  • the computer 78 may also interface with a door lock controller 88 to allow or deny access to the room based on the identity of the person seeking access and based on ongoing activities in the room. For example, if another person is in the room entering items into inventory, the computer may be programmed to not allow access so as not allow outside RFID signals into the room and interfere with the ongoing inventory activity. The computer 78 may also be programmed to keep the door locked while an RFID scan is taking place, whether or not anyone is in the room. The computer 78 may also be programmed to deactivate the RFID reader 66 inside the room when the door is open so that no RFID tags on items outside the room will be detected.
  • the supply room computer 64 or the computer 78 controls the RFID tag reader(s) 66 to perform an RFID antenna calibration procedure.
  • This procedure may involve placing a known number of RFID-tagged items in various different storage bins 70 in the supply room 68 with the RFID tag reader 66 initially deactivated.
  • the computer 64 then activates the RFID tag reader 66 at a first relatively low transmitter power level and the number of tags detected is noted. If not all the tags present in the room were detected, the transmitter power level is increased by a small amount to a second power level that is greater than the first power level and the number of tags detected is noted. This procedure is repeated until all tags are detected, and the lowest transmitter power level at which all tags were detected is stored as the optimum operational level.
  • This general procedure could also be performed by starting at a relatively high transmitter power level at which all tags are detected and then stepping down in power until not all of the tags are detected.
  • FIG. 14 depicts a preferred embodiment of a system 200 for detecting fraud in the reporting of usage of medical items in the treatment of medical patients
  • FIG. 15 depicts a process performed by the system of FIG. 14 to detect and report such fraud.
  • the system 200 includes a supplier inventory computer 202 in communication with a supplier RFID tag encoder 204, both of which are disposed at a supplier facility.
  • the system 200 also includes a distributor inventory computer 210 in communication with a distributor RFID tag reader 208, both of which are disposed at a distributor facility.
  • a medical care facility inventory computer 214 is in communication with a supply room RFID tag reader 212 and a procedure room RFID tag reader 216, all of which are disposed at a medical care facility. As shown in FIG.
  • the procedure room RFID tag reader 216 is the tag reader 28 connected to the antennas 14a-14b in the shielded enclosure 12 disposed in a medical procedure room. Another embodiment of the procedure room RFID tag reader 216 is the tag reader 46 connected to the antennas 50a-50d in the portal 48.
  • the supplier inventory computer 202 and the medical care facility inventory computer 214 are in communication with a UDI Serialized Tracking Database 218.
  • the database 218 is maintained at the facility of a third party UDI fraud detection service provider.
  • the medical item supplier assigns each individual instance of a medical item a unique identification number (e.g. GS1, SGTIN, EPC, etc.) that is encoded in an RFID tag 206 attached to the device or its packaging.
  • a unique identification number e.g. GS1, SGTIN, EPC, etc.
  • the unique identification number is preferably encoded in the RFID tag 206 for each item at the time of manufacture using the tag encoder 204 (step 302 in FIG. 15).
  • RFID chip security is utilized to lock the RFID tag 206 after programming to prevent the unique identification number on the tag from being modified.
  • the unique identification number is also visually displayed on the packaging and encoded in a barcode on the packaging.
  • the unique identification number encoded in the RFID tag 206 is assigned to the corresponding UDI (i.e. DI and PI) for the particular medical item and is registered with the UDI fraud detection service provider for storage in the UDI Serialized Tracking Database 218 (step 304). Preferably, this registration process is performed at the time of manufacture.
  • the tagged medical items are shipped from the supplier to the distributor (step 305), and the tags on incoming items are read at the distributor facility using the distributor RFID tag reader 208 (step 306).
  • the distributor computer 210 then communicates with the UDI Serialized Tracking Database 218 to update the status of the tagged medical items (step 308).
  • the tags on the incoming items are read using the supply room RFID tag reader 212 (step 312).
  • the care facility computer 214 then communicates with the UDI Serialized Tracking Database 218 to update the status of the tagged medical items (step 314).
  • the unique identification number of the item is logged by scanning the RFID tag attached to or embedded in the item or its wrapper using the RFID tag reader 216 in the procedure room (step 318).
  • the RFID tags on item wrappers are automatically read when the wrappers are dropped into the shielded enclosure 12 (FIG. 1). In alternative embodiments, the RFID tags on or embedded in item wrappers are automatically read when the wrappers pass through the portal 48.
  • the care facility computer 214 then communicates with the UDI Serialized Tracking Database 218 to update the status of the tagged medical items (step 320). Using this information, the UDI fraud detection service provider can track the status (i.e., used in patient care or not yet used in patient care) of each individual instance of each medical item.
  • the medical care provider submits the unique identification numbers encoded in the RFID tags 206 of used items in a bill to a payer (step 322).
  • the bill payer or any other entity wishing to validate that the devices listed on bills were actually used during patient care, may access the UDI Serialized Tracking Database 218 such as via a dedicated website to perform an anti-fraud check (step 324).
  • a check involves two steps: (a) checking that the submitted unique identification number is valid for the UDI (e.g.
  • a fraud alert message is generated (step 330).
  • a fraud alert message is also generated if the unique identification number has been submitted previously in association with a prior patient care event (step 328). Fraud alert messages may be provided in the form of emails, text messages, notifications on a UDI fraud check website screen, or by other forms of electronic messaging.
  • an automatic fraud check is triggered based on the reading of an RFID-tagged wrapper dropped into the shielded enclosure (step 318) and the logging of the decoded unique identification number into the database 218.
  • This automatic fraud check (indicated by the dashed line in FIG. 15.) preferably occurs independently of the submission of a bill to a payer.
  • the automatic fraud check may find potential problems even before a bill is submitted to a payer. For example, during the automatic fraud check, it may be determined at step 328 that the unique identification number for the used item matches the unique identification number of an item that was logged previously into the database 218 as being used in a procedure.
  • the first "use” of the item must have been logged fraudulently in order to inflate a bill. This information can be used to investigate the first logged "use” to either track down the perpetrator of the fraud or to determine whether a mistake was made due to negligence or carelessness rather than an intentionally fraudulent act.

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Abstract

Au moment de la fabrication d'articles médicaux qui doivent être utilisés lors de soins à des patients, un numéro d'identification unique est attribué à chaque article et ce numéro est codé dans une étiquette RFID fixée à l'article. Le fabricant enregistre le numéro d'identification unique pour chaque article médical dans une base de données de suivi sérialisé d'identification de dispositif unique (IDU). La base de données de suivi sérialisé IDU met en correspondance chaque numéro d'identification unique avec le numéro IDU de chaque article qui a été attribué par l'administration américaine chargée des aliments et des médicaments (FDA). Lorsqu'un article est utilisé au cours d'un traitement médical et que son coût est facturé à des payeurs, le numéro d'identification unique de l'article est enregistré et vérifié. Cela permet la détection de certains types de fraude lors de la distribution d'articles médicaux car cela apporte la confirmation que les fournitures nécessaires ont été réellement utilisées lors de soins à des patients.
PCT/US2017/061243 2016-11-15 2017-11-13 Système de prévention de la fraude en matière d'utilisation d'articles médicaux WO2018093706A1 (fr)

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CN111178793A (zh) * 2019-11-25 2020-05-19 万马科技股份有限公司 基于rfid的医用高值耗材的入库方法
US20220199240A1 (en) * 2020-12-23 2022-06-23 Sage Products, Llc Systems and methods for medical device task generation and management

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WO2016040593A1 (fr) * 2014-09-11 2016-03-17 Deroyal Industries, Inc. Système pour suivre de l'utilisation et de la consommation d'articles médicaux dans un établissement médical et pour tenir à jour une chaîne de garde sur la base de celui-ci

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2016040593A1 (fr) * 2014-09-11 2016-03-17 Deroyal Industries, Inc. Système pour suivre de l'utilisation et de la consommation d'articles médicaux dans un établissement médical et pour tenir à jour une chaîne de garde sur la base de celui-ci

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111178793A (zh) * 2019-11-25 2020-05-19 万马科技股份有限公司 基于rfid的医用高值耗材的入库方法
US20220199240A1 (en) * 2020-12-23 2022-06-23 Sage Products, Llc Systems and methods for medical device task generation and management

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