Patent Publication Number: US-2009234673-A1

Title: Method and system for automated management of tissue information

Description:
FIELD 
     The present disclosure relates generally to the automated management of tissue information, and more particularly, to a method and system for inputting to a database information relating to tracked movement of tissue through receiving, storage, issuance, implantation or transfer to post-operative activities. 
     BACKGROUND 
     The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) delineates multiple requirements regarding storage and maintenance of tissue and biologics. As a requirement for accreditation, records must be kept and updated at prescribed times to document the continuous monitoring of tissue. 
     The JCAHO requires a healthcare facility to implement standardized procedures to acquire, receive, store and issue tissues. For example, continuous temperature monitoring for refrigerators and freezers must be performed and documented. Records must be kept daily to show that a tissue was stored at the required temperature (e.g., 15°-30° C.). Further, all hospital records, including storage records of the tissue and all superseding procedures, are required to be kept for a minimum of 10 years. 
     Conventionally, doctors and healthcare facility staff manually record and update storage and maintenance information of tissue, using handwritten notes on a document affixed to a container holding the tissue. Merely recording such information on a single document may result in missing documentation required by the JCAHO due to unintentionally overlooking tissue information or forgetting to monitor storage conditions, as well as human error in the documentation. Missing and inaccurate records can result in product spoilage and/or endangering a patient by implanting contaminated tissue. 
     SUMMARY 
     The presently disclosed embodiments are directed to solving one or more of the problems presented in the prior art, described above, as well as providing additional features that will become readily apparent by reference to the following detailed description when taken in conjunction with the accompanying drawings. 
     One or more aspects of the present disclosure are directed to a method for automated management of tissue information. The method comprises prompting a user to input tissue information at a user terminal; and inputting to a database the tissue information. According to certain aspects, a patient record is created in the database including the tissue information. The tissue information, according to certain embodiments, may include at least one of intake tissue information upon receiving a tissue, inventory information, preparation information, and usage information of the tissue. 
     One or more other aspects of the present disclosure are directed to a system for automated management of tissue information. The system comprises one or more user terminals configured to prompt a user to input to a database the tissue information; and a processing unit configured to create a record in the database including the tissue information. The tissue information, according to certain embodiments, may include at least one of intake tissue information upon receiving a tissue, inventory information, preparation information, and usage information of the tissue. 
     One or more aspects of the present disclosure are directed to a computer-readable medium storing instructions thereof for performing a method of automated management of tissue information. The method comprises prompting a user to input tissue information at a user terminal; and inputting to a database the tissue information. According to certain aspects, a patient record is created in the database including the tissue information. The tissue information, according to certain embodiments, may include at least one of intake tissue information upon receiving a tissue, inventory information, preparation information, and usage information of the tissue. 
     As will become evident by the following Description and Drawings, automated management of tissue information ensures data integrity, thereby reducing tissue spoilage and providing improved patient safety with better clinical outcomes. The prompting of a user to input tissue data better ensures that the data will be entered and the records will have the required integrity. 
     Of course, the present invention is not limited to the aforementioned embodiments, and other features of the embodiments will become apparent after review of the hereinafter set forth Brief Description of the Drawings, Detailed Description, and the Claims, or may be learned by practice of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing aspects of the embodiments described herein will become more readily apparent by reference to the following detailed description when taken in conjunction with the accompanying drawings wherein: 
         FIG. 1  is a graphical illustration of a system for automated management of tissue information, according to one or more disclosed embodiments. 
         FIG. 2  is a flow diagram showing a method for automated management of tissue information, according to one or more disclosed embodiments. 
         FIG. 3  is a flow diagram showing a method for updating tissue information, according to one or more disclosed embodiments. 
         FIGS. 4(   a ) and  4 ( b ) are screenshots of intake information of a tissue entered by a user, according to one or more disclosed embodiments. 
         FIG. 5  is a screenshot showing prompted storage information, according to one or more disclosed embodiments. 
         FIG. 6  is a screenshot showing prompted patient information, according to one or more disclosed embodiments. 
         FIG. 7  is a screenshot showing preparation information provided to a user at a user terminal, according to one or more disclosed embodiments. 
         FIG. 8  is a screenshot showing prompted preparation information, according to one or more disclosed embodiments. 
         FIG. 9  is a screenshot showing post-operative information, according to one or more disclosed embodiments. 
         FIG. 10  is a screenshot showing prompted post-operative information, according to one or more disclosed embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to the presently disclosed embodiments, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. 
     In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It will be obvious, however, to one ordinarily skilled in the art that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology. 
     Embodiments of the present disclosure address and solve problems related to tissue management, including that of maintaining the integrity of data records related to the tissue, which can be caused, for example, by failure to record, or attempting to maintain and secure manual documentation. These and other concerns are solved, at least in part, by embodiments of the present invention that provided, for example, a method for automated management of tissue information. The method comprises prompting a user to input tissue information at a user terminal; and inputting to a database the tissue information. According to certain embodiments, a patient record is created in the database including the tissue information. 
       FIG. 1  is a graphical illustration of a system for automated management of tissue information, according to one or more disclosed embodiments. Upon receipt of tissue at an unloading dock or a tissue bank, an electronic reception record  100  is established in database  20  for the tissue via user terminal  10 ( a ). A user (not shown) may be prompted at terminal  10 ( a ), for example, to enter a tissue ID and type. It is noted that generation of the tissue ID may be performed as described in application Ser. No. ______, entitled “METHOD AND SYSTEM FOR IMPLANT RECORD INTAKE USING A UNIQUE IMPLANT ID”, with the same inventors as the present application and filed concurrently herewith, and which is expressly incorporated herein by reference. 
     In addition, the user may be prompted to enter intake tissue information including a tissue lot number, an expiration date, a supplier name, necessary storage temperature, the date and time at which the tissue is received, the person receiving and/or inspecting the tissue, receipt of tissue testing results and/or the condition of the tissue upon arrival. Of course, the foregoing information entered into database  20  via user terminal  10 ( a ) is merely exemplary and other information, as well as various combinations of the foregoing information, may be entered. 
     According to certain embodiments, one or a plurality of user terminals  10 ( a ) may be used to enter the intake tissue information. Each user terminal  10 ( a ) may prompt a user to enter required intake tissue information and communicates the intake tissue information to database  20  via a connection  30 ( a ), which may be a wireless connection (e.g., WiFi) or a hard-wired connection (e.g., a local area network). According to certain embodiments, the user terminal  10 ( a ) is a device previously incorporated into a local area network and/or wireless local area network, complying with IEEE 802.11 standards. According to other embodiments, user terminal  10 ( a ) may communicate with database  20  via the internet. Any conventional means of communication, however, may be employed between the user terminal  10 ( a ) and database  20 . 
     After receipt of the tissue, according to certain embodiments an inventory record  110  including inventory information may be established in database  20 , which may include movement and acceptance information at various locations, dispensing information and storage conditions of the tissue. The storage temperature of the tissue may be obtained every 15 minutes using, for example, an automated supply dispensing system; however, any conventional temperature monitoring device may be employed. Inventory information may be input to the database  20  using one or a plurality of user terminals  10 ( b ), which may be an automated supply dispensing system that stores and monitors the storage temperature of the tissue automatically every 15 minutes, for example, and transmits the storage temperature to database  20 . 
     Each user terminal  10 ( b ) may prompt a user to input required inventory information, and communicates the inventory information to database  20  via a connection  30 ( b ). According to certain embodiments, the user may periodically update the inventory record  110  at predetermined time intervals using one or more user terminals  10 ( b ). In addition, the user may search for the inventory record  110  in the database  20  using the tissue ID or any other category of inventory information in order to check the status of the tissue. 
     Connection  30 ( b ) may be a wireless connection (e.g., WiFi) or a hard-wired connection (e.g., a local area network). According to certain embodiments, the user terminal  10 ( b ) is a device previously incorporated into a local area network and/or wireless local area network, complying with IEEE 802.11 standards. According to other embodiments, user terminal  10 ( b ) may communicate with database  20  via the internet. Any conventional means of communication, however, may be employed between the user terminal  10 ( b ) and database  20 . 
     According to certain embodiments, a preparation and usage record  120  including preparation and usage information may be established before the tissue is implanted. The preparation information may include the date, the user, the preparation methodology including a reconstituting agent, ancillary materials and the condition of the tissue before implantation. The usage information may include the date, the patient the clinicians involved with implantation, procedure steps for the implantation and the condition of the tissue during implantation. Of course, these specific items of preparation and usage information are merely exemplary, and other information may be included. 
     Preparation and usage information may be entered at one or a plurality of user terminals  10 ( c ), possibly located within an operating room. Each user terminal  10 ( c ) may prompt a user to input required preparation and usage information and communicates the inventory information to database  20  via a connection  30 ( c ), which may be a wireless connection (e.g., WiFi) or a hard-wired connection (e.g., a local area network). According to certain embodiments, the user terminal  10 ( c ) is a device previously incorporated into a local area network and/or wireless local area network, complying with IEEE 802.11 standards. According to other embodiments, user terminal  10 ( c ) may communicate with database  20  via the internet. Any conventional means of communication, however, may be employed between the user terminal  10 ( c ) and database  20 . 
     According to certain embodiments, a post-operation record  130  may be established following tissue implantation. The post-operation record  130  may include post-operative patient reaction information such as the patient name, medical record number, implanting physician, type of tissue implanted, date of implant, date of any adverse outcome, patient symptoms, name of person reporting adverse reaction, name of person obtaining the post-operative patient reaction information and the date the post-operative patient reaction information was obtained. The functionality of the implant should be tested to determined if an explant is necessary. Results of such tests also must be included in the post-operative patient reaction information. Of course, these items of information are merely exemplary, and additional information may be included without departing from the scope of the present disclosure. 
     Post-operative patient reaction information may be entered at one or a plurality of user terminals  10 ( d ). Each user terminal  10 ( d ) may prompt a user to input required post-operative patient reaction information and communicates the inventory information to database  20  via a connection  30 ( d ), which may be a wireless connection (e.g., WiFi) or a hard-wired connection (e.g., a local area network). According to certain embodiments, the user terminal  10 ( d ) is a device previously incorporated into a local area network and/or wireless local area network, complying with IEEE 802.11 standards. According to other embodiments, user terminal  10 ( d ) may communicate with database  20  via the internet. Any conventional means of communication, however, may be employed between the user terminal  10 ( d ) and database  20 . 
     According to certain embodiments, a patient record  140  is created in database  20  which may include the tissue ID along with the corresponding intake tissue information, inventory information, preparation information, and usage information of the tissue that is associated with a patient. Subsequently, the post-operative patient reaction information may be added to the patient record. 
       FIG. 2  is a flow diagram showing a method for automated management of tissue information, according to one or more disclosed embodiments. At operation  200 , a user is prompted to input tissue information into a user terminal  10 ( a )- 10 ( d ). From operation  200 , the process proceeds to operation  210 , where the user inputs at the user terminal any required tissue information. The tissue information may include intake tissue information upon receiving a tissue, inventory information, preparation information, and usage information of the tissue. The tissue information may be input at various user terminals  10 ( a )- 10 ( d ) at various times, and is stored in database  20  communicatively coupled to the user terminal(s)  10 ( a )- 10 ( d ). 
     According to certain embodiments, from operation  210 , the process may proceeds to operation  220 , where a patient record is created in database  20 , which includes the tissue information associated with a particular patient. A tissue ID unique to the tissue to be implanted may be appended to the patient record. 
     The tissue information may be updated manually or automatically at various times and at various user terminals  10 ( a )- 10 ( d ) to document changing conditions or locations of the tissue, and/or to document the continuous monitoring of storage conditions, as required by the JCAHO. For example, the tissue may be moved to a different storage area or held under different storage conditions, and the storage temperature of the tissue must be monitored every 15 minutes. In this case, the inventory record  110 , for example, must be updated in database  20  accordingly to reflect the new location and/or storage condition, as well as the newly monitored storage temperature. Automated inventory methods may be employed to reflect the new storage location of the tissue. 
       FIG. 3  is a flow diagram showing a method for updating tissue information, according to one or more disclosed embodiments. At operation  300 , a user at a user terminal  10 ( a )- 10 ( d ) updates tissue information by inputting new and/or different information regarding a particular tissue. Also, the tissue information can be updated automatically, such as providing temperature readings every 15 minutes, for example. The terminal  10 ( a )- 10 ( d ) communicates the information to database  20  via communication line  30 ( a )- 30 ( d ), respectively, where the updated tissue information is stored. 
     From operation  300 , the process continues to operation  310  where a processor (not shown) communicatively coupled to database  20  updates the patient record associated with the tissue with the new and/or different information. 
     The patient record  140 , as well as any tissue information relating to the tissue, may be searchable in the database  20  based on, for example, the tissue ID, using one of the user terminal(s)  10 ( a )- 10 ( d ). In this manner, a user is able to determine past and current conditions and exact location of a tissue at any time and from various locations. 
       FIGS. 4(   a ) and  4 ( b ) are screenshots of intake information of a tissue entered by a user, according to one or more disclosed embodiments. As shown in  FIG. 4(   a ), a user terminal  10 ( a ) at the loading dock, for example, prompts a user to enter a Facility Item ID, a Serial Number, a Donor/Lot ID, a Tissue Size, a Tissue Type, a Catalog Number and an Expiration Date. Of course, these items are merely exemplary, and the user terminal  10 ( a ) may prompt the user to enter other information or various combinations of this exemplary information. Further, various user terminals  10 ( a )- 10 ( d ) may be used to input the intake information. After inputting the prompted information,  FIG. 4(   b ) shows the tissue information, as it is stored in database  20 . 
       FIG. 5  is a screenshot showing prompted storage information, according to one or more disclosed embodiments. For example, the user may be prompted at user terminal  10 ( b ), for example, to enter a temperature range including a low storage temperature  510  and a high storage temperature  520 . The user may also be prompted to enter a storage type  530  (e.g., a type of cabinet in which tissue is stored), and a storage location  540  within a healthcare facility. Of course, these items are merely exemplary, and the user terminal  10 ( b ) may prompt the user to enter other information or various combinations of this exemplary information. Further, various user terminals  10 ( a )- 10 ( d ) may be used to input the storage information. The storage information is stored in database  20  and associated with previously input tissue information. 
       FIG. 6  is a screenshot  600  showing prompted patient information, according to one or more disclosed embodiments. As shown in  FIG. 6 , a user may search for a particular tissue using a unique tissue ID at box  610 . Of course, one skilled in the art would understand that various information items may be used to search for the particular tissue (e.g., a lot number or serial number). Once a patient is scheduled to be implanted with a particular tissue, patient information  620  may be input at a user terminal  10 ( a )- 10 ( d ). The patient information  620  may include a patient ID, patient name, date of birth, location and gender. The patient information  620  may further include the surgeon performing the implantation, the date/time of the implantation, and the procedure type. Of course, these items are merely exemplary, and the user terminal  10 ( a )- 10 ( d ) may prompt the user to enter other information or various combinations of this exemplary information. Thereafter, patient information  620  will be stored in the patient record  140  within database  20 , and associated with the corresponding tissue information. 
       FIG. 7  is a screenshot  700  showing preparation information provided to a user at a user terminal, according to one or more disclosed embodiments. As shown in  FIG. 7 , a user may search for a particular tissue using a unique tissue ID at box  610 . Of course, one skilled in the art would understand that various information items may be used to search for the particular tissue (e.g., a lot number or serial number). Using a user terminal  10 ( c ) (e.g., in an operating room), a user (e.g., a physician or medical staff member) may be prompted by a handling and preparation wizard  710  providing handling and preparation directions for implanting a particular tissue identified at box  610 . This automated handling and preparation information assures that the user does not overlook a preparation step in preparing the tissue for implantation. 
       FIG. 8  is a screenshot  800  showing prompted preparation information, according to one or more disclosed embodiments. As shown in  FIG. 8 , a user may search for a particular tissue using a unique tissue ID at box  610 . Of course, one skilled in the art would understand that various information items may be used to search for the particular tissue (e.g., a lot number or serial number). Using a user terminal  10 ( c ) (e.g., in an operating room), a user (e.g., a physician or medical staff member) may be prompted by a handling and preparation wizard  810  to enter particular preparation information for a particular tissue identified at box  610 . The preparation information may include, for example, the implantation site, who is preparing the tissue, graft type, a solution used, re-hydration time, a solution product code, a solution lot number, a solution serial number, a solution expiration date, and any other notes. Automated handling and preparation information assures that the user does not overlook a preparation step in preparing the tissue for implantation. Of course, these items are merely exemplary, and the user terminal  10 ( c ) may prompt the user to enter other information or various combinations of this exemplary information. 
       FIG. 9  is a screenshot  900  showing recall management, according to one or more disclosed embodiments. At box  910 , a user may search for a particular tissue by donor/lot ID, serial number or vendor. Of course, one skilled in the art would understand that various information items may be used to search for the particular tissue. A user may choose a particular tissue from the search results, which provide unique tissue IDs, delivery locations, patient names, physician names and date of surgeries. By choosing a particular tissue, any recall action  910  will appear, which may include the date and time of the recall action  910  and the type of recall action  910 . The user may add additional comments to be recorded in database  20  and associated with the particular tissue and the corresponding patient record  140 . For example, the user may enter any steps performed to notify the patient receiving the tissue or the surgeon performing the implant of a recall action. The user may also enter any notification procedures taken in order to notify the vendor of the tissue subject to the recall action. 
     In the case of a recall action, the recall management system shown in  FIG. 9  allows a user to easily search for information relating to a particular tissue, donor or vendor. By a search using the donor/lot ID, the serial number or the vendor, a user may determine the patient receiving the recalled tissue and the surgeon performing the implant. Thus, all tissue information of the recalled tissue may be easily obtained and steps may be taken to notify the patient, surgeon and vendor of the recall action. 
     Further, the recall management system shown in  FIG. 9  provides an automated mechanism by which a user may produce documentation required during a JCAHO audit, for example. In the case that a healthcare facility receives a recall notice, the JCAHO may request documentation regarding what tissue of a specified lot number has been implanted and to whom. Documentation may also be requested to show what steps have been taken to notify the patient receiving the tissue and the surgeon performing the implant. Notification information as to whether the vendor of the tissue has been notified may also be requested. Thus, as all of the tissue information is previously entered and centrally stored in database  20  a user may easily produce an audit trail associated with each tissue. 
       FIG. 10  is a screenshot  1000  showing prompted post-operative information, including adverse reactions, according to one or more disclosed embodiments. At box  910 , a user may search for a particular tissue by donor/lot ID, serial number or vendor, using a user terminal  10 ( a )- 10 ( d ). Of course, one skilled in the art would understand that various information items may be used to search for the particular tissue. At box  1010 , the user may record adverse reaction details associate with the particular tissue, such as a patient ID, a patient name, an implant ID, the date any adverse reactions were reported, the patient symptoms, any additional notes and the like. The adverse reaction details  1010  will be stored in database  20  and associated with the corresponding tissue information and patient record  140 . 
     The methods and systems described herein solve the challenges that acute care hospitals face in managing tissue and biologics from the point of intake through storage, implantation, records archival and recall management. The foregoing aspects provide the opportunity to generate an automated process that will help hospitals fully comply with the JCAHO regulations and contribute to improved patient outcomes. Specifically, automated management of tissue information ensures data integrity, thereby reducing tissue spoilage and providing improved patient safety with better clinical results. 
     Moreover, by prompting a user to input certain required information, a hospital or healthcare facility can avoid having missing documentation required by the JCAHO due to unintentionally overlooking tissue information or forgetting to monitor storage conditions. Since the tissue information, and the associated patient record, is stored on a centralized database  20 , all tissue information is easily searchable and updatable. 
     In addition, storing all tissue information on a centralized database  20 , allows easy recall management. Patients, surgeons and vendors may be quickly and efficiently determined and notified of a recall action, and all tissue information relating to a recalled tissue may be easily produced. Also, audit trail production is simplified since all information regarding the recall action and notification procedures for the patient, surgeon and/or vendor are easily searchable, as all tissue information is associated with the Donor/Lot ID and the serial number of the tissue in the database  20 . 
     The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. 
     All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” 
     It is understood that the specific order or hierarchy of steps or operations in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps or operations in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps or operations in a sample order, and are not meant to be limited to the specific order or hierarchy presented.