System and method for preventing wrong-site surgeries

Abstract

A container holds at least one surgical implement, has a lock mechanism, and has a signature label that impedes access to the surgical implement until the correct surgical site is confirmed. A method of using the container includes the steps of confirming the correct surgical site, signing the label and removing it from the container, placing the label in the medical record, unlocking the container, removing the implement, and beginning the surgery, wherein the surgical team is forced to pause to confirm the correct surgical site before starting the surgery. The system and method may also include a wrong site surgery profile used by individuals within the surgical procedure environment and third parties for tracking and determining if, and where, a wrong site surgical procedure occurred. The profile can be updated, tacked and monitored while a patient is interacting within the medical environment.

What is claimed is: 
     
         1 . A method of preventing or tracking a wrong-site error during surgery comprising:
 identifying an individual in need of a surgical procedure;   providing a wrong site surgical procedure electronic profile for said individual, said wrong site surgical procedure electronic profile associated with said surgical procedure to be performed on said individual;   associating said wrong site surgical procedure electronic profile to a surgical container containing surgical instruments for said surgical procedure, said surgical container configured to contain at least a removable label including a checklist for confirming surgery-related information and one or more fields for signatures positioned on said surgical container to prevent or impede access to said surgical instrument stored therein and a data capture or data display device;   tracking said wrong site surgical procedure status of said patient as said patient moves within a surgical procedure environment;   updating said electronic profile as said individual moves through said surgical procedure environment.   
     
     
         2 . The method of preventing a wrong-site error during surgery according to  claim 1  further including the step of providing a final report after said individual has completed movement within the surgical procedure environment. 
     
     
         3 . The method of preventing a wrong-site error during surgery according to  claim 1  further including the step of associating a visual indicator to said container, said visual indicator providing a user visual confirmation as to a site on said individual where the surgical procedure should occur. 
     
     
         4 . The method of preventing or tracking wrong-site error during surgery according to  claim 1  wherein said visual indicator is a color coding, wherein said color indicates a procedure on an anatomical part on the left side, right side, or no lateral side of said individual in need of a surgical procedure. 
     
     
         5 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  further including the step of associating said container with said patient in need of a surgical procedure occuring when said patient is scheduled for a surgical procedure. 
     
     
         6 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  further including the steps of:
 at the site of surgery, obtaining said container; 
 verifying a correct surgical site and filling in the surgical-site information input field of the label with the surgical-site information to conduct a pre-surgery assessment confirming the correct surgical site; 
 removing the label from the container and saving it as a medical record for later documentation that the pre-surgery assessment confirming the correct surgical site was in fact conducted; 
 opening the container and removing the at least one surgical implement, and using the at least one surgical implement at the outset of the surgery, 
 wherein the pre-surgery assessment confirming the correct surgical site is timely conducted before opening the container, removing the at least one surgical implement, and starting the surgery with the at least one surgical implement, 
 wherein timely conducting the pre-surgery assessment is prompted by the label being positioned to prevent or at least impede opening the container, and wherein the initial position, input field, and removal of the label effectively accomplish the dual purposes of first forcing the prompt for the pre-surgery assessment and then second documenting that the pre-surgery assessment in fact was conducted. 
 
     
     
         7 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  wherein said step of verifying a correct surgical site includes obtaining data from said data capture and/or display device. 
     
     
         8 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  further including the step of associating biometric data with said wrong site surgical procedure electronic profile. 
     
     
         9 . The method of preventing or tracking a wrong-site error during surgery according to  claim 8  wherein said biometric data associated with said wrong site surgical procedure electronic profile includes fingerprint data, face recognition data, iris recognition data, retina scan data, DNA data, or combinations thereof. 
     
     
         10 . The method of preventing or tracking a wrong-site error during surgery according to  claim 8  further including the steps of obtaining biometric data of as said patient moves within said surgical procedure environment; and
 updating said wrong site surgical procedure electronic profile with said updated biometric data. 
 
     
     
         11 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  further including the step of obtaining wrong site surgical data on said patient as said patient moves through said surgical procedure environment. 
     
     
         12 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  further including the step of obtaining wrong site surgical data on said patient as said patient movies through said surgical procedure environment; and
 modifying said wrong site surgical procedure electronic profile based on said updated wrong site surgical data captured as said patient moves within the surgical procedure environment. 
 
     
     
         13 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  wherein said obtaining wrong site surgical data associated with said wrong site surgical procedure electronic profile includes data obtained from a data capture device, a sensor, a wireless data transfer device, a camera, or combinations thereof. 
     
     
         14 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  wherein said wrong site surgical procedure electronic profile includes real time data obtained from one or more cameras, recorded data from said one or more cameras, or combinations thereof. 
     
     
         15 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  wherein said wrong site surgical procedure electronic profile contains verification that a final timeout has been performed. 
     
     
         16 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  wherein said wrong site surgical procedure electronic profile contains one or more decision input indications that said surgical procedure occurred, said surgical procedure did not occur, or said surgical procedure was paused. 
     
     
         17 . The method of preventing or tracking a wrong-site error during surgery according to  claim 1  wherein said wrong site surgical procedure electronic profile contains final disposition of said surgical procedure, wherein said final disposition surgical procedure information includes indication that a final payment or disbursement of funds occurred. 
     
     
         18 . A system for preventing or tracking a wrong-site error during a surgical procedure, comprising:
 a container having a top portion containing a first locking portion adapted to engage with a second locking portion, and a bottom portion containing a second lock portion adapted to engage with said first locking portion;   one or more surgical implements positioned within the one or more compartments;   a lock mechanism that secures the container in a closed position;   a removable label including a checklist for confirming surgery-related information and one or more fields for signatures, said label positioned within said container to prevent or impede access to at least a portion of said lock mechanism without first removing the label; and   a data capture and/or display device secured to at least one portion of said container.   
     
     
         19 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  further including a wrong site surgical procedure electronic profile. 
     
     
         20 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said data capture device uses optical machine-readable representation of data. 
     
     
         21 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said data capture device is a radio frequency identification transponder. 
     
     
         22 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said top portion contains a first lock opening sized and shaped to receive a locking pin and said bottom portion contains a second lock opening sized and shaped to receive a locking member, said bottom portion adapted to slidably engage said top portion whereby said top portion and said bottom portion are movable between a closed position and an open position, each said lock opening positioned within said top or bottom portion to form an overlapping orientation to receive said lock member when in the closed position. 
     
     
         23 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 22  wherein said lock mechanism that secures the container in the closed position comprises a locking pin having at least one portion for linearly engaging said top and bottom portion when said container is in said closed position. 
     
     
         24 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said container is adapted to provide a visual indication for indicating a surgery site. 
     
     
         25 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said visual indication is a color coding. 
     
     
         26 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said top or bottom portion includes one or more compartments for holding surgical instruments. 
     
     
         27 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  further including biometric data of a patient electronically linked to identification of said container. 
     
     
         28 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 19  further including one or more devices for capturing patient information. 
     
     
         29 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 28  wherein said one or more devices for capturing patient information is electronically linked to said wrong site surgical procedure electronic profile. 
     
     
         30 . The system for preventing or tracking a wrong-site error during a surgical procedure according to  claim 18  wherein said wrong site surgical procedure electronic profile includes wrong-site surgery near miss data, wrong-site surgery error data, or combinations thereof.