Tissue management system

• US 10,671,706 B2
• Filed: 10/19/2007
• Issued: 06/02/2020
• Est. Priority Date: 09/21/2006
• Status: Active Grant

• Current Assignee: Biomedical Synergies, Inc.
• Original Assignee: Biomedical Synergies, Inc.
• Inventors: Kasprisin, Duke O, Kozloski, Paul E., Kozloski, Susan A., Vercillo, Agnes, Winstead, Jeffrey K.
• Primary Examiner(s): Najarian, Lena
• Application Number:
  US11/975,525
• Publication Number:
  US 20080215363A1
• Time in Patent Office: 4,610 Days
• Field of Search: 702 19
• CPC Class Codes: G06Q 10/08 Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

The present invention provides a comprehensive tissue management system for transplantable materials like tissues and organs. The tracking portion of the system prompts and verifies that staff members of a medical establishment like a hospital have handled, stored, transported, reconstituted, and used the tissue or organ materials in a safe and regulatory-compliant manner from the point of receipt to the point of issuance or surgical use throughout the hospital'"'"'s organization. The tracing portion of the system creates an integral record that documents which hospital staff members have provided which processing steps to the tissue or organ, any associated materials used in conjunction with such tissue or organ, and an identification of the tissue or organ that was transplanted or implanted inside a patient. Such a system will enable adverse reaction investigations for transplant patients, and recalls of transplantable materials.

Claims

1. A computer-implemented tissue tracing management system for tracing a piece of transplantable material received by a specific medical establishment from a supplier throughout an internal life of the transplantable material within the medical establishment until it is transplanted or implanted into a patient, such system comprising:

(a) a data base that stores information associated with the patient or transplantable material;

(b) a central processing unit and an internal or external memory unit incorporating a software program containing an expression of an organized set of instructions in coded language coupled to the database;

(c) such software program including a plurality of graphical user interfaces having one or more fields for input of data and one or more check boxes to be selected by a staff member, the software program incorporating a comprehensive set of standard operating procedures adopted by the specific medical establishment for documentation of a present location within the medical establishment of the transplantable material, and a login, handling, process treatment, thawing, rehydration, reconstitution, or use by a staff member of the transplantable material within the medical establishment, and at least one step for a proper login, handling, storage conditions, reconstitution, or surgical use of the transplantable material by staff members of the medical establishment in a manner compliant with prevailing safety regulations and industry mandates, at least one of the data input fields or check boxes being responsive to requirements under the standard operating procedures, the system in combination with the standard operating procedures programmed to;

(i) assign a unique identification code for the transplantable material upon its receipt by the medical establishment from the supplier;

(ii) require through the graphical user interface data entry within the field or selection of a check box by a staff member for the documentation of the completion of each step comprising login, handling, storage conditions, location movement, process treatment, thawing, rehydration, reconstitution, or surgical use applied by a staff member to the transplantable material within the medical establishment in conformity with the standard operating procedures;

(iii) require through the graphical user interface data entry within the field or selection of a check box by a staff member for the documentation of the present location of the transplantable material within the medical establishment;

(iv) require through the graphical user interface data entry within the field or selection of a check box by a staff member for the documentation of each staff member'"'"'s identity who comes into contact with the transplantable material;

(v) require through the graphical user interface data entry within the field or selection of a check box by a staff member for the documentation of a date and time for each processing step applied by a staff member to the transplantable material;

(vi) require through the graphical user interface data entry within the field or selection of a check box by a staff member for the documentation of all materials used by a staff member to prepare and process the transplantable material;

(vii) require through the graphical user interface data entry within the field or selection of a check box by a staff member for the documentation of the unique identification code of the transplantable material transplanted or implanted into the patient; and

(viii) upon a search query executed by a staff member, trace the transplantable material back to the supplier that supplied it to the medical establishment, to the login, handling, storage, process treatment, thawing, rehydration, reconstitution, or surgical use step applied by a staff member of the medical establishment to the transplantable material, or forward to the patient into whom the transplantable material was transplanted or implanted;

(ix) if the staff member has not inputted data into a required field or selected a required check box in the previous graphical user interface, the software program does not allow the staff member to proceed to the next graphical user interface;

(d) wherein the system is programmed to force the staff members in the medical establishment to properly carryout such documentation and tracing steps in accordance with the adopted standard operating procedures incorporated into the system by completing the required data entry fields or selecting the required check box for one graphical user interface before the next graphical user interface can be accessed;

(e) wherein the system is programmed to compare the content of the entered data field or check box against the contents of the adopted standard operating procedures that correspond to that processing step for the login, handling, storage conditions, reconstitution, or surgical use processing step to verify that the staff member properly carried out that processing step in compliance with the standard operating procedure, and;

(i) if compliance exists, then the software program allows the staff member access to the next graphical user interface relating to the next processing step for the login, handling, storage conditions, reconstitution, or surgical use of the transplantable material; and

(ii) if compliance does not exist, then the software program does not allow the staff member to access the next graphical user interface relating to the next step for the login, handling, storage conditions, reconstitution, or surgical use of the transplantable material;

(f) wherein the transplantable material is chosen from the group consisting of human cells, tissue, or organs intended for implantation, transplantation, infusion, or transfer to a patient, including, but not limited to;

musculoskeletal tissues including bone, tendons, fascia, ligaments, cartilage, and bioengineered bone products;

skin;

cardiovascular tissues including heart valves, arteries, veins, and pericardium;

reproductive cells including sperm, semen, oocytes, fertilized eggs, and embryos;

cellular therapies including stem cells, progenitor cells, cord blood, chondrocytes, bone marrow, and neural cells;

dura mater;

breast milk;

eyes;

corneas;

organs;

islet cells;

parathyroids;

autologous tissue; and

synthetic and xenographic tissue used as replacements for human tissue;

as well as non-biologic implants, including but not limited to;

titanium screws, titanium or carbon-fiber cages or resorbable cages, fixation systems, saline or silicone breast implants, synthetic polymers, prosthetic hips, knees and other joint combinations thereof;

as well as surgical instruments, equipment, reagents, and supplies associated with the transplanting or implanting of any transplant material into a patient; and

(g) wherein the medical establishment is an organization directed to the storage, research, transplantation, or implantation of transplantable materials chosen from the group consisting of hospitals, medical clinics, surgical centers, fertility clinics, tissue banks, organ donor banks, university and research facilities, diagnostic laboratories, and willed body programs.

2. The computer-implemented tissue tracing management system of claim 1 further comprising means for designating one or more staff members of the medical establishment with specific responsibility for conducting each of the programming elements (ii-viii).

3. The computer-implemented tissue tracing management system of claim 1 further comprising means for sending to the supplier a tissue utilization information card for the transplantable material transplanted or implanted to the patient.

4. The computer-implemented tissue tracing management system of claim 1, wherein the tracing step is conducted in response to an adverse reaction detected in the patient into whom the transplantable material was transplanted or implanted.

5. The computer-implemented tissue tracing management system of claim 4 further comprising means for notifying the supplier that supplied the transplantable material to the medical establishment of the adverse reaction in the patient.

6. The computer-implemented tissue tracing management system of claim 1, wherein the tracing step for element (viii) is conducted in response to a recall received from the supplier that supplied the transplantable material to the medical establishment.

7. The computer-implemented tissue tracing management system of claim 1 further comprising means for ensuring that a staff member of the medical establishment who performs any of the steps documented in response to programming elements (ii-viii) possesses a relevant educational background or receives relevant training for performing such step.

8. The computer-implemented tissue tracing management system of claim 1 further comprising a visual or audible warning provided within the graphical user interface to the staff member if one of the required data input fields has not been completed when the staff member tries to access the next graphical user interface.

9. The computer-implemented tissue tracing management system of claim 1, wherein the information contained within the database comprises data regarding the supplier.

10. The computer-implemented tissue tracing management system of claim 1, wherein the information contained within the database comprises the storage conditions of the transplantable material.

11. The computer-implemented tissue tracing management system of claim 1, wherein the information contained within the database comprises clinical data concerning the patient.

12. The computer-implemented tissue tracing management system of claim 1, wherein the information contained within the database comprises clinical data concerning the transplant or implant surgery.

13. The computer-implemented tissue tracing management system of claim 1 further comprising means for reporting a list of certified suppliers of transplantable material.

14. The computer-implemented tissue tracing management system of claim 1 further comprising means for reporting certification credentials of a particular supplier.

15. The computer-implemented tissue tracing management system of claim 14, wherein the certification credentials are selected from the group consisting of Food &

Drug Administration registration, American Association of Blood Banking accreditation, American Association of Tissue Banks (“

AATB”

) accreditation, Eye Bank Association of America (“

EBAA”

) accreditation, and licensure within a relevant geographic region.

16. The computer-implemented tissue tracing management system of claim 1 further comprising functional means for reporting results of an audit conducted by the specific medical establishment upon the supplier.

17. The computer-implemented tissue tracing management system of claim 1 further comprising functional means for reporting an order placed for a purchase of transplantable material.

18. The computer-implemented tissue tracing management system of claim 1 further comprising means for reporting a quality inspection assessment of transplantable material received from the supplier.

19. The computer-implemented tissue tracing management system of claim 1 further comprising means for reporting the present location of transplantable material within the medical establishment.

20. The computer-implemented tissue tracing management system of claim 1 further comprising means for reporting a storage history within the medical establishment of a piece of transplantable material.

21. The computer-implemented tissue tracing management system of claim 1 further comprising means for reporting results of an adverse reaction investigation with regard to a piece of transplanted material.

22. The computer-implemented tissue tracing management system of claim 1 further comprising means for automatic monitoring of an actual temperature condition of a storage unit containing the transplantable material against a temperature condition contained in the standard operating procedures.

23. The computer-implemented tissue tracing management system of claim 1, wherein the comparison of the content of the data field or check box entered by the staff member against the contents of the adopted standard operating procedures that correspond to that processing step for the login, handling, storage conditions, reconstitution, or surgical use processing step to verify that the staff member properly carried out that processing step in compliance with the adopted standard operating procedure is produced by the presence within a GUI screen of one or more check boxes that need to be selected by the staff member corresponding to the adopted standard operating procedure, or a preprogrammed look-up table containing valid content for that data entry made by the staff member.

24. The computer-implemented tissue tracing management system of claim 1 further comprising auto population by the system of one or more data fields within a graphical user interface screen with data entered by the staff member into a previous graphical user interface screen, or data programmed into the system in order to ensure that data entered into system between multiple graphical user interface screens is consistent.