Abstract:
A tag comprises a procedure region for displaying information relating to a clinical procedure, and an input region for receiving identifiable indications of responsible persons. The presence of the identifiable indication of each responsible person whose authorization is required indicates that the clinical procedure may be undertaken. In this way, it is highly unlikely that an incorrect clinical procedure is undertaken.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS  
       [0001]     This application claims priority to GB 0502685.1, filed Feb. 10, 2005, and GB 0510032.6, filed May 17, 2005, which disclosures are incorporated herein by reference.  
       BACKGROUND OF THE INVENTION  
       [0002]     The invention relates to the regulation of the administration of clinical procedures, including a tag for such regulation, a system and a method.  
         [0003]     GB 2 378 430 discloses a bracelet for preventing surgery on a wrong limb or organ. The bracelet includes an indication of which side of the patient should be operated on, and three boxes for the initials of the patient, a first doctor and a surgeon. The bracelet is particularly directed to “sided” surgery.  
         [0004]     An object of the invention is to reduce the probability of an incorrect clinical procedure being undertaken on a patient.  
         [0005]     Another object of the invention is to provide a means of requiring the authorization of responsible persons, including the agreement of the patient, for a clinical procedure to be undertaken.  
         [0006]     A further object of the invention is to provide a system which prohibits access to a clinical area in which a clinical procedure is to be undertaken until the authorization of responsible persons is obtained.  
       BRIEF SUMMARY OF THE INVENTION  
       [0007]     According to a first aspect of the invention, there is provided a tag comprising a procedure region for indicating information relating to the clinical procedure, and an input region for receiving identifiable indications of predetermined responsible persons.  
         [0008]     By “clinical procedure” is meant any surgical, diagnostic, treatment or other procedure, and the word “clinician” should be construed accordingly.  
         [0009]     By “identifiable indication” is meant a signature, initials, fingerprint, username/password, code (for example that encoded in a swipecard) or anything else which may be used to identify a person.  
         [0010]     By “responsible persons” is meant the patient, and/or a first clinician, and/or a clinician who is to perform the clinical procedure. One way of operating is to require authorization from all three before the procedure can begin. If the patient is not competent, then a relative of the patient&#39;s or two clinicians may sign on the patient&#39;s behalf.  
         [0011]     The tag demands interaction between the clinician(s) and the patient to establish a correct procedure. The tag is filled out and positioned, followed by the clinician performing the procedure again checking notes, x-rays (for example), letters and the patient to ensure that the correct clinical procedure is to be performed.  
         [0012]     The presence of the identifiable indication of each responsible person whose authorization is required indicates that the clinical procedure may be undertaken.  
         [0013]     In this way, the possibility that an incorrect clinical procedure is undertaken is substantially reduced.  
         [0014]     In a preferred embodiment, the tag comprises a sheet of paper or card with the procedure region and the input region being printed boxes in which responsible persons may sign.  
         [0015]     In another embodiment, the tag comprises an electronic device. The procedure region may be or include an LCD screen or other electronic display device. The tag displays requests for authorization from each responsible person in turn. The input region is a touch-sensitive screen for receiving signatures, initials or fingerprints of responsible persons in response to the displayed requests.  
         [0016]     In yet another embodiment, the procedure region is electronically stored in the memory of the tag and is not visibly displayed. The procedure-related information may be retrievable on demand for display by an electronic display device. The input region includes one button assigned to “yes” and another button assigned to “no”. Each responsible person may choose to give or withhold authorization by pressing the appropriate button. Alternatively, the tag may allow the responsible person to scroll up or down between options and to select accordingly. Each clinician may verify his identity by entering a username and password or by means of a swipecard.  
         [0017]     The tag may further include a sidedness region for indicating that the clinical procedure is sided, and may further indicate on which side of the patient the procedure is to be performed. In a preferred embodiment, the sidedness region displays the words “operate on this side”, with a responsible person ensuring that the tag is attached to the correct side of the patient. Alternatively, a designated color or symbol may indicate the correct side.  
         [0018]     The sidedness region may be concealed beneath a removable covering, to avoid possible confusion when the clinical procedure is unsided. The removable covering may be a peel- or scratch-away covering, for example. In another embodiment, the sidedness region is located on a detachable portion of the tag.  
         [0019]     The tag may further include a strap for attaching the tag to the patient, the tag being attachable to the strap only at one side. Thus the other side is readily insertable into a reader.  
         [0020]     The tag may further include a pocket for storing a document holder, which holder may be folded within the pocket. The holder provides a ready means of storage for any paperwork that accompanies the clinical procedure, for example the patient&#39;s notes, thereby facilitating the audit process. The holder may be attached to the tag.  
         [0021]     The tag may further include a machine-readable portion for indicating which side of the tag contains the procedure region and input region. This facilitates the function of a reader which may be used with the tag.  
         [0022]     The tag may further include a barcode storing administrative information relating to the patient. In conjunction with a system capable of reading the barcode, this allows for the patient&#39;s progress and/or position to be monitored in real time, perhaps for administrative purposes. It also allows integration with electronic theatre systems and blood checking procedures (providing for a further confirmation of patient identity in relation to blood products given during a procedure). Electronic theatre systems chart the patient&#39;s entry time, along with other information, within the theatre for management audit.  
         [0023]     According to a second aspect of the invention, there is provided a system for regulating the administration of a clinical procedure, the system comprising a tag according to any preceding claim; a reader being operable to scan the tag for identifiable indications; an area access element being actuable to permit access to a clinical area in which the clinical procedure is to be performed; and a processor connected to each of the reader and area access element, the processor being operable to actuate the area access element upon detection of an identifiable indication for each responsible person.  
         [0024]     In this way, the patient is physically denied access to the clinical area until the appropriate authorization has been given.  
         [0025]     By “clinical area” is meant any operating theatre or other room in which the clinical procedure is performed.  
         [0026]     In a preferred embodiment, the area access element is an electrically-actuable door lock.  
         [0027]     The reader may include an optical scanner being operable to create an image of at least part of the tag. The processor may include image-recognition means for detecting in the image the presence of identifiable indications.  
         [0028]     The system may further include display means to display the image. The image may be displayed in the clinical area, for the benefit of the clinician(s) and support staff who are there. The image may include identifiable indications and/or the procedure-related information stored on the tag, along with other information derived from barcode of the tag.  
         [0029]     The display means may display a request for final confirmation, the system further including input means for receiving such confirmation. This additional level of authorization further reduces the chance of an incorrect clinical procedure being undertaken. In a preferred embodiment, the input means is a touch-sensitive screen on the display means. Alternatively, a keyboard, mouse or other standard means is used.  
         [0030]     The system may further include storage means for storing a record of such confirmation and/or the image.  
         [0031]     The reader may be operable to read a barcode on the tag, the barcode storing administrative information relating to the patient, the processor being operable to receive the administrative information from the reader and transmit it to an administrative system.  
         [0032]     By “administrative system” is meant any system which stores or uses any information relating to the patient, and includes the electronic theatre systems and blood checking systems, for example.  
         [0033]     The administrative information may include details of any allergies which the patient has. The system may prohibit the patient access to the clinical area until a clinician has acknowledged such details.  
         [0034]     The reader may be operable to detect on the tag a machine-readable portion for indicating which side of the tag contains the procedure region and input region.  
         [0035]     According to a third aspect of the invention, there is provided a tag comprising a machine-readable input region for receiving identifiable indications of responsible persons.  
         [0036]     The tag may be used in conjunction with the system of the second aspect of the invention to prevent access to a clinical area until appropriate authorization has been obtained.  
         [0037]     The input region may be machine-readable by way of its location on an extending portion of the tag, the extending portion being insertable into a reader.  
         [0038]     According to a fourth aspect of the invention, there is provided a method of regulating the administration of a clinical procedure, the method comprising preventing a patient access to a clinical area in which the clinical procedure is to be performed until an associated tag according to the invention receives an identifiable indication for each predetermined responsible person.  
         [0039]     The method may further comprise the preceding step of verifying that the information contained in or on the tag is correct.  
         [0040]     According to a fifth aspect of the invention, there is provided a method of regulating the administration of a clinical procedure, the method comprising requiring authorization from predetermined responsible person(s) before a clinical procedure can be undertaken.  
         [0041]     The requiring step may comprise each responsible person making an identifiable indication to indicate that his authority is given.  
         [0042]     The identifiable indication may be a signature; initials; fingerprint; username and/or password; or code.  
         [0043]     The responsible persons may include the patient or a relative of his, a first clinician and a clinician performing the procedure.  
         [0044]     The method may include, prior to the requiring step, the step of interacting between the clinicians and the patient to establish and/or confirm a correct procedure and/or a side of the patient.  
         [0045]     The method may include, between the interacting and requiring steps, the step of providing information on the procedure and/or side in a form which is readily available to the clinicians and patient.  
         [0046]     The method may include, between the providing and requiring steps, the step of providing means for an identifiable indication of the responsible persons&#39; authority to be given, those means being available alongside the information on the procedure and/or side.  
         [0047]     The method may include the step of preventing the patient access to a clinical area until appropriate authorization has been given. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0048]     In order that the invention may more readily be understood, a description is now given, by way of example only, reference being made to the accompanying drawings, in which:  
         [0049]      FIG. 1  is a front view of a first embodiment of a tag according to the invention;  
         [0050]      FIG. 2  is a rear view of the tag of  FIG. 1 ;  
         [0051]      FIG. 3  is a partial front view of a second embodiment of a tag according to the invention;  
         [0052]      FIG. 4  is a schematic diagram of a system according to the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0053]      FIG. 1  shows the front side of a first embodiment of a tag  100  according to the invention, the tag  100  including a tag body  102  and a strap  120 .  
         [0054]     The tag body  102  includes a number of printed boxes in which a person may write, and is approximately the size of a typical luggage label. The tag  100  is made of vinyl plastic.  
         [0055]     A procedure region  106  displays information relating to a clinical procedure.  
         [0056]     An input region  108  provides room for the signatures of responsible persons, those persons being a first clinician, the patient, and a clinician who is to perform the clinical procedure.  
         [0057]     The tag body  102  includes a sidedness region  104  for indicating on which side of the patient the procedure is to be performed. The sidedness region  104  displays the words “OPERATE ON THIS SIDE”. The sidedness region  104  is originally concealed beneath a removable covering (not shown) displaying the words “For procedures on one side peel off”. The covering is removed only when the clinical procedure is sided.  
         [0058]     The strap  120  includes a number of holes  122 , one being engaged with a locking pin  124  when the tag  100  is attached to the patient. The tag may be attached to the patient&#39;s ankle or wrist using the strap  120 . Alternatively, the tag  100  may be attached to a necklace using aperture  116 . Importantly, the tag body  102  is attached to the strap  120  only at one side, allowing the unattached side to be inserted into a reader, as will be described below.  
         [0059]     The tag body  102  includes a machine-readable portion  114  for indicating to a reader which side contains the procedure region  106  and input region  108 .  
         [0060]      FIG. 2  shows the rear side of the tag body  102 , including a pocket  130  for storing a folded document holder, and a barcode  132  storing administrative information relating to the patient.  
         [0061]     In use, the clinicians interact with the patient to establish or confirm a correct procedure and side, fill out the procedure region of the band, and position the band on the patient. The position is particularly important in the case of a sided procedure.  
         [0062]     The clinicians and the patient examine the contents of the procedure region  106  and the sidedness region  104  (if needed), checking the contents against the notes, x-rays, letters and the patient to ensure that the clinical procedure is correct. If the contents are correct, each person signs the appropriate box in the input region  108 , thereby giving their authorization for the clinical procedure to be undertaken.  
         [0063]     In effect, the tag provides for a protocol which states that the patient will not progress or undergo the clinical procedure if the tag is not present and appropriately initialed.  
         [0064]     The protocol states also that the patient must be denied access to a clinical area in which the clinical procedure is to be performed, until the tag is present and initialed.  
         [0065]      FIG. 3  shows the front side of a second embodiment of a tag  200  according to the invention.  
         [0066]     In this embodiment, the sidedness region  204  may be detached from the tag body  102  by way of perforated region  205 .  
         [0067]      FIG. 4  shows a system  10  according to the invention, the system  10  including a reader  12 , a processor  14 , an electrically-actuable door lock  16 , an LCD/plasma monitor  18 , a network  20 , and an administrative system  22 .  
         [0068]     The system assists in implementing the protocol described above.  
         [0069]     The reader  12  includes an optical scanner (not shown), which creates an image of the front side of the tag  100  when the tag  100  is inserted into the reader  12 . The machine-readable portion  114  of the tag  100  indicates to the reader  12  which side is the front side.  
         [0070]     The reader  12  is connected to the processor  14 , which contains image-recognition means (not shown) for detecting signatures in the image. To this end, the system includes storage means (not shown) storing electronic images of each responsible person&#39;s signature, in order to check that only duly authorized people have signed the appropriate boxes, and to provide recall in the event of an untoward clinical accident.  
         [0071]     The image taken of the tag  100  by the reader  12  is passed to the processor  14 , which compares the contents of the input region  108  in the image with its stored images of the signatures of the responsible persons concerned. The barcode  132  of the tag includes the names of the patient and of each member of the clinical team, whereby the processor  14  selects which stored images of signatures are to be retrieved.  
         [0072]     If each signature matches, the processor  14  actuates the door lock  16 , which unlocks a door to a clinical area in which the clinical procedure is to be performed.  
         [0073]     The monitor  18  is located inside the clinical area, and displays the image once it has been obtained, for the benefit of the patient, clinicians and support staff.  
         [0074]     In addition, after the image has been displayed, the processor causes the monitor  18  to display a request for final confirmation. The monitor  18  includes a touch-sensitive screen, whereby clinicians in the clinical area can respond to the request by giving confirmation that the information contained in the image is correct.  
         [0075]     The storage means stores a record of such confirmation, in addition to the image.  
         [0076]     In addition to scanning the front side of the tag  100 , the reader  12  scans the rear side also, in order to obtain the administrative information stored in the barcode  132 . The processor  14  receives the administrative information from the reader  12  and transmits it to the administrative system  22  via the network  20 . The administrative system  22  monitors the patient&#39;s progress and/or position in real time.