Patent Application
20110015945
The present invention relates to authentication and verification systems utilizing biometric input, and more specifically, to a system and method of utilizing iris recognition to accurately administer medication to a patient.
Hospitals and other medical facilities dispense large numbers of prescription and over the counter drugs, medications, vaccines and other biological products. This dispensing process is a significant source of inaccuracy due to medication errors including the administration of medication to the wrong patient often resulting in severely adverse patient reactions. Since medical facility pharmacies dispense millions of medication doses annually, even a small error rate is significant when consideration is given to the extremely harmful potential implications of such an error.
Due at least partially to recently issued FDA regulation requirements and motivated by an attempt to alleviate identification and medication error rates, medical facilities have implemented a process of attaching bar codes to most prescription and over the counter drugs. Medical facilities have long distributed a wristband containing a bar code to each patient upon enrollment or registration as a patient in the facility. Since both the wristband and the medication contain a bar code identifying the patient, a system of scanning each bar code to determine a patient match developed and has been universally used in the process of dispensing medication.
However, the bar code system, and specifically the wristband element, has significant potential for error which has rendered the wristband bar code solution inadequate. For example, errors have arisen due to workarounds taken by health care professionals (Koppel R, et al “Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety.” J. Am. Med. Inform. Assoc. 2008; 15: 408-423) including removing the wristband bar code and affixing it instead to the nursing station, computers-on-wheels (COWs), supply room, patient's room door jam, medication dispensing machine, medical professional's clipboard, the scanner itself, and on the medical professional's sleeve, belt or pocket, overriding due to frustration with readability of bar code due to scanning technique, uncertainty as to scan effectiveness, or uncertainty as to audible nature of verification alarm and refusing to scan due to the scanner being tethered to a COW which will not fit in patient's room or the scanning equipment being too bulky to transport to a supply room or refrigerator. In addition to medical professional workarounds, bar codes on wristbands present the potential for a number of other errors due to the bar code being unreadable because it is cut, smudged, chewed, deteriorated by fluids, inaccessible because it was never provided, was previously removed, or is covered with sterile dressing or blankets, invalid due to it being from a prior hospital admission or inaccurate because it was incorrectly assigned.
In addition to violating the right person and right medication patient rights, other sources of error in medical facilities include administering medication at the wrong time or at the wrong frequency, of the wrong dose, to a patient having the wrong blood type, and through the wrong means, for example.
Accordingly, there is a need in the art for a substantially accurate system and method that reduces the possibility for error in the process of administering medication in a medical facility while being highly portable and/or handheld and easy to use for a health care professional.
These and other features and advantages will be better understood by reading the following detailed description, taken together with the drawings wherein:
Recognition, verification and authentication systems and methods have long used physiological biometrics such as fingerprint recognition, facial recognition, iris recognition, vascular recognition, hand/palm geometry, DNA, and retina recognition among many others. Each of these methods has various advantages and disadvantages as well as error rates. Because it is widely believed that iris recognition is among the most accurate biometric parameters with significantly reduced error rate due to the iris being unique for each individual, having a highly detailed pattern, and being stable over many years beginning at a very young age (less than 24 months of development) and because the iris is typically highly accessible to medical facility personnel, among other reasons, the following specification describes one embodiment of the present invention which utilizes iris recognition as the biometric parameter. However, it should be noted that any biometric capable of being obtained using a 2D imager and decoding program instructions can replace iris recognition as the biometric used in the biometric medication administration system and method of the present invention.
Referring to
The optical reader 100 also includes one or more programmable control means such as a processor 116 and/or a microprocessor such as a VLSI integrated circuit microprocessor. The processor 116 is configured to receive, output and process data, including image/pixel data, in accordance with instructions stored in a data storage means 122 such as a local, network-accessible, removable and/or non-removable memory, such as RAM, ROM, and/or flash, operate the imaging 102 and illumination assemblies 108, and communicate with a system bus 138 among other operations. More specifically, the processor 116 may be configured to control the illumination of the at least one light source 112, the timing of the image sensor 106, analog-to-digital conversion, transmission and reception of data to and from a processor of a remote computer 136 external to the reader through a network interface 134, such as an RS-232, RS-485, USB, Ethernet, Wi-Fi, Bluetooth, IrDA and/or Zigbee interface, and control an output device 202, such as an LCD or an OLED display, through the display interface 132. Even more specifically, in a preferred embodiment as noted above, the processor is configured to control the illumination of the at least one light source 112 such that when implementing program instructions including the capture of an iris image, as discussed below, at least one near-infrared LED is engaged in order to allow for increased quality and reliability of the imaging of dark irises. Similarly, in the preferred embodiment, the processor is configured to control the illumination of the at least one light source 112 such that when implementing program instructions including the capture of a bar code image, as discussed below, at least one visible light LED is engaged. Alternatively, in another embodiment, at least one visible light LED is engaged by the processor during both iris and bar code image capture. In yet another embodiment, the processor can be configured to control the iris image capture process such that successive iris images are captured, stored, and used in the enrollment and/or administration processes, as fully described below, wherein one iris image is captured using near-infrared light and one iris image is captured using visible light. The optical reader 100 also includes one or more power supplies 128, such as one or more batteries and/or circuitry for receiving an alternating current, and a user input interface 130 for receiving data from a user input device 204, such as a keyboard, keypad, and/or touch screen. The optical reader 100 structures shown in
The one or more printed circuit boards are supported within a housing 200 such as the housing 200 shown in
Referring again to
The overall operation of the system will now be described with respect to the method steps shown in
Referring to
However, preferably, the same program instructions used by the enrollment device to determine an iris code from an iris image 306 are stored in the iris decode module 124 of the biometric medication administration system described above so as to increase the stability of iris image decoding thereby reducing error rates and false negative indications. Accordingly, in another embodiment, the biometric medication administration system described above can also be used for patient enrollment. In this embodiment, the data storage means 122 described above further contains an enrollment module having program instructions that, when implemented by the processor 116, facilitate user interaction with the system to capture an enrollment iris image and convert the enrollment iris image to an enrollment iris code 306.
In one embodiment, once the enrollment iris code is determined at step 306, it is stored in a database 308 in association with the patient identification information stored previously in step 302. Accordingly, the database contains a record having patient information such as the patient's name. When an iris code is determined in step 306, the iris code is stored as being associated with the patient's name in the record 308.
In another embodiment, step 304 and step 306 occur in that order but prior to step 302 such that an image of the patient's iris is captured and decoded prior to patient identification information being stored in a database. In this embodiment, the patient's iris code is stored in a database and, subsequently, the patient's identification information is stored as being associated with the patient's iris code.
In yet another embodiment step 302 is eliminated and no patient identification information is stored in the database. However, in this embodiment, preparing medication including associating a medication bar code value with a patient in the database requires knowledge of the patient's enrollment iris code instead of other identification information such as the patient's name or social security number.
In one embodiment, the database is a relational database and the patient is represented by one tuple or record of a table. In this embodiment, the patient's name, for example, and the patient's iris code are attributes or fields associated with the record representing the patient.
In the embodiment in which a biometric medication administration system is used for patient enrollment, the database can be stored in a local data storage means and the same biometric medication administration system is also used for associating a medication with a patient 400 as described below with respect to
If a medical facility maintains the convention of issuing a wristband containing a bar code to a patient as part of the patient enrollment process, the bar code value can also be stored in the database as an attribute in the record representing the patient.
Referring to
Referring to
Accordingly, the verification program 125 can cause the display 202 to prompt the user to press ascan/capture button 206, or otherwise interact with the system, so as to image the patient's iris 504 and, optionally, store the current iris image in local or remote data storage means 122 subsequent to any image processing such any necessary analog to digital conversion. Next at step 503, the verification program 125 causes the processor 116 to retrieve the program instructions from the iris decode module 124 and implement the program instructions so as to convert the iris image to a current iris code. The verification program 125 then causes the processor 116 to store the current iris code in local or remote data storage means 508.
Next, and still prior to dispensing the medication, the verification program 125 can cause the display 202 to prompt the user to press a scan/capture button 206, or otherwise interact with the system, so as to image the current medication bar code 510 and, optionally, store the current medication bar code image in local or remote data storage means subsequent to any image processing such as analog to digital conversion. Next, the verification program 125 causes the processor 116 to retrieve the program instructions from the bar code decode module 126 and implement the program instructions an as to convert the medication bar code image to a current medication bar code value 512. The verification program 125 then causes the processor 116 to store the current medication bar code value in local or remote data storage means 514.
Subsequent to current iris code and current medication bar code conversion at steps 506 and 512, respectively, in one embodiment, the verification program 125 proceeds to query the database to retrieve the patient record associated with the current iris code 515. Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518.
If the current medication bar code value matches a medication bar code value previously stored as associated with the patient (see step 406 described above), the verification program 125 causes a positive verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a positive verification 520. In one embodiment, subsequent to a positive verification message, the verification program automatically removes the medication bar code value's association with the patient in the database. Accordingly, the health care professional can administer the medication and feel confident that the correct patient has been identified as the patient appropriate for administration of the specific medication.
In another embodiment, prior to communication of a positive verification message 520 but after verifying patient identify and medication type, the verification program can query the database to retrieve the record associated with the medication to retrieve at least one relevant attribute stored in the database such as dosage, administration time/frequency, or means of administration. Accordingly, the system can display a question as to dosage, administration time or intended means of administration causing the health care professional to answer the question or at least see the information thereby reducing the potential for error. Should the health car professional confirm that the display has been read/received, a positive verification message can then be communicated.
In another embodiment, also prior to communication of a positive verification message 520 but after verifying patient identify and medication type, the verification program can query the database to retrieve both the record associated with the medication and the record associated with the patient and compare the blood type attribute associated with the medication to the blood type attribute associated with the patient for a match. Assuming the medication has been entered into the database as intended for patients having a blood type matching that of the current patient, the system can then cause a positive verification message to be communicated.
In yet another embodiment, also prior to communication of a positive verification message 520 but after verifying patient identify and medication type, the verification program can query the database to retrieve the record associated with the medication and compare the previously entered time for administration to an internal clock and/or the previously entered last time the medication was administered to the patient. Assuming the time for administration is appropriate, the system can then cause a positive verification message to be communicated.
If no matching medication bar code exists either because the medication having the current medication bar code was not for administration to the patient and/or because no patient having a matching enrollment iris code was enrolled in the medical facility, the verification program 125 causes a negative verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a negative verification 522. Optionally, the verification program 125 can be configured to indicate to the health care professional, by way of a display method or otherwise, the reason for the negative verification. Accordingly, the health care professional can be made aware that administering the specific medication to the patient may be an error and that further investigation should be pursued prior to administration.
In another embodiment, the verification program 125 queries the database to retrieve the patient record associated with the current medication bar code value instead of the current iris code. Assuming a unique bar code value for each prepared medication, there is a one-to-one relationship between iris codes and medication bar code values. Accordingly, in this embodiment, at step 516 of
In one embodiment where a conventional wristband containing a bar code is issued to a patient upon enrollment the process can further include the verification program 125 further causing the display 202 to prompt the user to press a scan/capture button 206, or otherwise interact with the system, so as to image the patient's wristband bar code and, optionally, store the current wristband bar code image in local or remote data storage means subsequent to any image processing such as analog to digital conversion. Next, the verification program 125 causes the processor to retrieve the program instructions from the bar code decode module 126 and implement the program instructions so as to convert the wristband bar code image to a current wristband bar code value. The verification program 125 then causes the processor 116 to store the current wristband bar code value in local or remote data storage means. Accordingly, in this embodiment, the step 516 of comparing the current medication bar code value to the previously stored medication bar code value associated with the patient further includes comparing the current wristband bar code value to the previously stored wristband bar code value associated with the patient to determine whether there is a match.
Once a positive or negative verification message is displayed at steps 520 or 522, respectively, the verification program 125 can end/exit and/or cause the system to power off or display a message asking the health care professional if another medication is to be administered to the patient at this time 524. In the latter embodiment, the health care professional engages the keypad 204 or otherwise communicates to the system that either another medication bar code is to be read in which case the verification program proceeds to step 510 of
It should be noted that in one embodiment wherein the processor is configured to control the iris image capture process such that successive iris images are captured, one using light in the near-infrared range and one using light in the visible range, as described above, the step of imaging 504 requires two image captures, the step of converting 506 requires two iris code conversions, the step of storing 508 requires storing two current iris codes, and the step of querying 515 can require querying the database to retrieve a patient record associated with either or both current iris codes. Since matching iris codes acquired from images captured using near-infrared light and visible light can result in reduced effectiveness and increased error rate, this embodiment allows for the administration process 500 to proceed with increased effectiveness irrespective of whether only near-infrared or only visible light was used to image the patient's iris at step 304 of the enrollment process 300.
In another embodiment in which the processor is configured to control the iris image capture process such that successive iris images are captured, one using light in the near-infrared range and one using light in the visible range, as described above, and the biometric medication administration system of the present invention is used in the enrollment process 300, the step of imaging 304 of the enrollment process 300 requires two image captures, the step of converting 306 requires two iris code conversions, and the step of associating 308 requires associating both enrollment iris codes with the patient in the database. In this embodiment, the administration process 500 can proceed with increased effectiveness irrespective of whether only near-infrared or only visible light is used to image the patient's iris at step 504 of administration process 500.
In one embodiment, upon discharge from the medical facility, the patient is removed from the database such that the patient record is deleted requiring the enrollment process to repeat should the person be admitted to the medical facility as a patient in the future. In another embodiment, the patient record contains an attribute indicating whether the patient is active or inactive such that upon discharge from the medical facility the patient record is labeled as inactive. Accordingly, in this embodiment, when the database is queried at step 515 of
While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims.
