Abstract:
The invention is a method of obtaining error free consent for medical and surgical treatment. Software is used to generate an error free consent documentation. The software stores the correct name/names of the facilities, physicians, specialties and procedures and allows the user to print out (or store) the consent by selecting them from the drop down windows.

Description:
[0001]    CROSS REFERENCE TO RELATED APPLICATIONS  
         [0002]    This invention claims the priority date of provisional patent 60/387,417 filed on Jun. 11, 2002. 
     
    
     
       BACKGROUND OF INVENTION  
         [0003]    1. Field of the Invention  
           [0004]    The present invention relates to methods for obtaining informed consent to a medical or surgical treatment, particularly for medical procedures such as a hysterectomy, sterilization, a blood transfusion, psychiatric treatment, dental procedures, anesthesia, and the like. More specifically, the present invention relates to interactive simple, fool proof methods for generating a document without errors, i.e. spelling errors, with disclosed information regarding the medical procedure.  
           [0005]    2. Background  
           [0006]    Virtually every medical procedure performed in the United States, including psychiatric treatment and dental procedures, requires that the patient consent to the procedure. This consent may either be expressed or implied. A competent adult patient can implicitly consent to a procedure by his/her situation or his/her actions. Examples of this type of consent would include certain emergencies and typical physical examinations. Consent to such procedures is implied by the patient. While it is frequently deemed acceptable, it is not the type of consent preferred by the medical community and is to be avoided where possible.  
           [0007]    Expressed consent is preferred by the medical community. At present, expressed consent is usually oral or written. The inherent difficulty in proving details with respect to oral consent makes this type of expressed consent less preferable for most health care providers. Using existing techniques, many non-emergency type surgical procedures require the patient to read and sign an “informed consent” form. These procedures, among many others, are deemed to require not merely consent, but informed consent.  
           [0008]    The legal requirements can be burdensome to healthcare providers. Not only does complying with such requirements take time, but the constantly changing state of the law and medical vocabulary makes merely remaining current in this developing field a challenge. Names of medical and surgical procedures are complicated or lengthy and are too many to be memorized by healthcare workers and providers. Medical terminology is constantly changing. This causes spelling errors or missing procedures on the consents leading to expensive lawsuits and embarrassing situations in the courtrooms. The present invention is designed to alleviate this imposition on medical personnel by providing a method of generating error free informed consent. The disclosed method improves the ability of generating an informed and personalized consent, and enhances the ability to prove in a court of law that informed consent was properly and professionally established, should it be necessary.  
           [0009]    For many years the only device used to indicate possible informed consent was a standard form where the healthcare provider fills the form by writing the required information such as the name of the treatment and the patient&#39;s name along with other information as required by local laws. Often the procedures are written incorrectly and when multiple procedures are to be written some procedures are missed due to the number of reasons. Staff finds it very cumbersome and difficult to open the dictionary, look up the procedure and write the proper procedure on the form. Staff in medical facilities just does not have the time to look up or memorize the procedures to be entered on the forms. These poorly written forms combined with the unfavorable outcomes of the treatment fueled by the litigious nature of our society, have contributed to the skyrocketing malpractice insurance fees experienced by many health care providers. These are, naturally, passed on to the patient in the way of higher medical fees charges or the substandard medical care.  
           [0010]    These poorly written consents can be very embarrassing to the doctors and nurses when presented in the court of law. The standard consent forms are difficult to modify to accommodate ever-changing needs of healthcare providers.  
           [0011]    In order to meet these needs, the present invention utilizes computer software that is not traditionally applied to the informed consent field.  
         SUMMARY OF INVENTION  
         [0012]    The present invention discloses methods for establishing patient&#39;s informed consent in conjunction with medical procedures and treatments, such as used in hospitals, clinics, surgery centers, doctors&#39; offices and other healthcare facilities. The disclosed methods provide a reliable and effective means for generating an informed consent which is error free. This invention serves to establish error free patient&#39;s consent to a medical/surgical treatment by providing interactive computer software.  
           [0013]    In general terms, the invention involves a unique method for generating error free informed consent. In one instance, the invention takes into account legal and medical requirements for establishing informed consent while providing an interactive process to allow documentation without the errors. Other features of the present invention include selecting the facility name, doctors or the patient&#39;s name as well as the physician specialty.  
           [0014]    This method can be used with a stand-alone system or incorporated into electronic medical records or any other medium of communication including but not limited to Internet Accordingly, the present invention provides a method which quickly generates patient informed consent with ease. It acts to provide both medical practitioners and patients with a consent that is error free. In addition, accepted medical and legal standards can be used.  
           [0015]    It is therefore broadly an object of the present invention to establish a method allowing for error free patient informed consent for a medical, surgical or dental procedure or treatment.  
           [0016]    It is another object of the present invention to design a system which is capable of generating patient&#39;s informed consent without errors and allowing for modifications as required by ever changing medical and legal needs.  
           [0017]    It is another object of the invention to provide a flexible system that can be modified to be used by any specialty for any treatment or a particular specialty for particular procedures and consents. 
       
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0018]    The drawing, which is incorporated in and constitute a part of this specification, illustrate a preferred embodiment of the invention and, together with the description, serve to explain the principles of the invention.  
         [0019]    [0019]FIG. 1—Displays a User interacting with the system;  
         [0020]    [0020]FIG. 2—Displays a Software Screen of the current invention; and  
         [0021]    [0021]FIG. 3—Displays a Software Screen of the current invention for use by a particular specialty.  
     
    
     DETAILED DESCRIPTION  
       [0022]    The preferred embodiment of the invention is described below.  
         [0023]    The present invention discloses methods for establishing patient&#39;s informed consent in conjunction with medical procedures and treatments, such as used in hospitals, clinics, surgery centers, doctors&#39; offices and other healthcare facilities. The disclosed methods provide a reliable and effective means for generating an informed consent which is error free. This invention serves to establish error free patient&#39;s consent to a medical/surgical treatment by providing interactive computer software.  
         [0024]    The current invention uses interactive computer software, protocol and languages that are known to one skilled in the art and therefore not disclosed here in detail.  
         [0025]    [0025]FIG. 1 illustrates a functional diagram of the system  1 . A user  10  at a specific location  20 , such as a clinic, hospital, doctor&#39;s offices or other healthcare facility, connects to a processor  100  that runs the system  1 . A user  10  is someone who inputs information into the system  1  or someone who wants to generate a consent form.  
         [0026]    A User  10  accesses the system using an informational processing system. A typical system that is used is a personal computer with an operating system such as Windows 95, 98 or ME or Linux. The exact hardware configuration of computer used by a User  10  and the brand of operating system is unimportant to understand this present invention.  
         [0027]    Those skilled in the art can conclude that any database language such as D-Base or a compatible language are well known in the art and within the true spirit of this invention and the scope of the claims.  
         [0028]    [0028]FIG. 2 shows a sample screen of the software version that can be used by any specialty for any treatment. The function of this screen is given below.  
         [0029]    A User  10  enters or selects the facility to appear on consent.  
         [0030]    An Add/Delete button is used to update the facility name.  
         [0031]    A User  10  enters or selects a patient&#39;s name. The last ten names (or the predefined number of names) are saved once a document is printed (or stored). The User  10  must select or enter a patient&#39;s name before printing (or storing) consent. The User  10  enters or select a doctor&#39;s name to appear on consent.  
         [0032]    An Add/Delete button is used to update the doctor&#39;s names.  
         [0033]    A User  10  selects a specialty. Add/Delete button is used to add, delete or modify the specialty and the procedures.  
         [0034]    A User  10  selects the procedure by checking the boxes. A User  10  can select up to predefined number of procedures. An Add/Delete button is used to add, delete or modify the procedures. A User  10  must select a procedure before printing (or storing) the consent.  
         [0035]    The Print (or save) button is used to print (or store) the consent. The consent is printed on a printing device connected to the system  1 .  
         [0036]    If person signing the consent is other than the patient, relationship of that person to the patient is selected from “Describe the relationship to the patient” window. An Add/Delete button is used to modify the description.  
         [0037]    A new date can be entered by clicking into the date box. Time is highlighted to enter a new time. Preview button is used to preview the consent before printing.  
         [0038]    A Modify consent button is used to modify the consent as needed.  
         [0039]    A Help button is used for help.  
         [0040]    A Quit button is used to close the application.  
         [0041]    [0041]FIG. 3 shows a sample screen of the software version that can be used by a particular specialty for particular procedures and consents.  
         [0042]    A User  10  enters or selects the facility to appear on consent. An Add/Delete button is used to update the facility name.  
         [0043]    A User  10  enters or selects a patient&#39;s name. The last ten (or the predefined number of names) names are saved once a document is printed (or stored).  
         [0044]    A User  10  must select or enter a patient&#39;s name before printing (or storing) consent.  
         [0045]    A User  10  enters or select a doctor&#39;s name to appear on consent. An Add/Delete button is used to update the doctor&#39;s names.  
         [0046]    A User  10  selects the type of consent to print by checking the box. The User  10  can check one or more boxes. One box can be active for the User&#39;s  10  convenience when application is started. A User  10  can check or uncheck any box.  
         [0047]    A User  10  selects the procedure by checking the boxes. A User  10  can select up to predefined number of procedures. An Add/Delete button is used to add, delete or modify the procedures. A User  10  must select a procedure before printing (or storing) the consent.  
         [0048]    The Print (or save) button is used to print (or store) the consent. The consent is printed on a printing device connected to the system  1 .  
         [0049]    If person signing the consent is other than the patient, relationship of that person to the patient is selected from “Describe the relationship to the patient” window. An Add/Delete button is used to modify the description.  
         [0050]    A new date can be entered by clicking into the date box. Time is highlighted to enter a new time.  
         [0051]    The Preview button is used to preview the consent before printing.  
         [0052]    The Modify consent button is used to modify the consent as needed.  
         [0053]    The Help button is used for help.  
         [0054]    The Quit button is used to close the application.  
         [0055]    The system  1  will allow for the consents to be signed and/or initialed electronically and storing the consents electronically for archival or for later retrieval in a memory storage means  310  which in the preferred embodiment is within the processor  100 .  
         [0056]    The system  1  can be used with a stand-alone processor  100  or incorporated into electronic medical records or any other medium of communication including but not limited to Internet  500 .  
         [0057]    With respect to the above description then, it is to be realized that the optimum relationships for the parts of the invention, to include variations in screens, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.  
         [0058]    Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.  
         [0059]    It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the claims. It is to be understood that the foregoing description is exemplary and explanatory but are not restrictive of the invention.