“System And Method For Preventing Wrong-Site Surgeries” in Patent Application Approval Process (USPTO 20230210555): Patent Application

2023 JUL 21 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventors Davis, Christopher (Arlington, VA, US); Dentry, Timothy Brian (McKinney, TX, US); Kerwood, John G. (Canton, GA, US); Khajavi, Kaveh (Atlanta, GA, US); Lane, II, David E. (Falkville, AL, US); Spangler, Jonathan David (San Diego, CA, US), filed on August 3, 2022, was made available online on July 6, 2023, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “A great deal of attention has recently been given to the unacceptable rate of avoidable patient injuries, or so-called medical mistakes, in the United States. Estimates of the number of medical mistakes per year in the United States is difficult to ascertain, but a recent publication, To Err is Human, by Dr. Lucian Leape, suggests that the avoidable death rate for medical mistakes are between 48,000 and 96,000 patients per year. Among the most avoidable medical mistakes are so-called “wrong-site” surgeries. As defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), wrong-site surgery includes wrong side or site of the body, wrong procedure, and wrong-patient surgeries.

“Prevalence of Wrong-Site Surgery

“From January 1995 to March 2001, JCAHO reviewed voluntary reports of 1,152 “sentinel events.” Wrong-site surgery accounted for 114 cases (9.9%) and included procedures in neurosurgery, urology, orthopedics, and vascular surgery. Despite the high profile of JCAHO’s Sentinel Event Policy, under-reporting by healthcare organizations likely affects these statistics. Only 66% of the 1,152 total events were “self-reported” by the institutions involved; the balance coming from patient complaints or media stories. Using a mandatory reporting system, the New York State Department of Health received 46 reports of wrong-site surgery from Apr. 1, 1998 through Mar. 31, 2000, compared with 114 cases JCAHO received nationally over a period 3 times longer. This suggests that voluntary incident reporting may grossly underestimate the true incidence of wrong-site surgery by a factor of 20 or more.

“The Physician’s Insurance Association of America (PIAA) reviewed the claims data from 22 malpractice carriers representing 110,000 physicians from 1985 to 1995. There were 331 cases of wrong-site surgery. The complete PIAA database documents almost 1,000 closed malpractice claims involving wrong-site surgery. However, this figure also likely underestimates the prevalence of wrong-site surgery. Since most wrong-site surgeries involve relatively minor procedures (arthroscopy, rather than limb amputations or major neurosurgical procedures), sequelae are minimal and may not result in a claim. Consequently, estimates of the incidence of wrong-site surgery derived from litigation data likely underestimate the true prevalence of this problem, as do estimates based on incident reports.

“Factors Contributing to Wrong-Site Surgery

“Several factors have been identified that may contribute to an increased risk of wrong-site surgery. These risk factors include: (a) More than one surgeon involved in the case, either because multiple procedures were contemplated or because the care of the patient was transferred to another surgeon; (b) Multiple procedures were conducted on the same patient during a single trip to the operating room, especially when the procedures were on different sides of the patient; © Unusual time pressures related to an unusual start time or pressure to speed up the preoperative procedures; and (d) Unusual patient characteristics such as physical deformity or massive obesity that might alter the usual process for equipment set-up or positioning of the patient.

“The root causes identified by hospitals were most often related to communication, preoperative assessment of the patient, and the procedures used to verify the operative site. Communication issues fall into two major categories: (1) Failure to engage the patient (or family, when appropriate) in the process of identifying the correct surgical site, either during the informed consent process or by the physical act of marking the intended surgical site; and (2) Incomplete or inaccurate communication among members of the surgical team, often through exclusion of certain members of the team (e.g., surgical technicians) from participation in the site verification process, or through reliance solely on the surgeon for determining the correct operative site.

“The completeness of the preoperative assessment of the patient was a frequent contributing factor, often through failure to review the medical record or imaging studies in the immediate preoperative period. The procedures for verifying the correct operative site were found to be flawed in many cases due to: No formal procedure; No final check in the operating room; The absence of any oral communication in the verification procedure; All relevant information sources not available in the operating room; No checklist to ensure all relevant information sources were checked; Some members of the surgical team were excluded from the verification process and felt they were not permitted to point out a possible error; and Total reliance on the surgeon for verifying the surgical site.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “The present invention addresses the unmet needs described above by providing a system and method for preventing wrong-site surgeries which includes a safety blade-dispenser. The present invention includes a system and related methods of preventing wrong-site surgeries and blade-related injuries to OR personnel. The system includes computer software system configured to provide a user with a method of preventing wrong site surgeries, in combination with surgery related equipment, preferably a surgical supply carrier (e.g. safety blade-dispenser or other surgical sharps dispenser). The surgical supply carrier comprises at least one component, such as a label, paper, or tape, which prevents or impedes a surgeon from accessing one or more surgical instruments stored within until after a “time-out” is performed by the surgeon or authorized OR personnel to confirm various details including but not limited to correct patient, correct procedure, correct equipment, etc, before starting the intended surgical procedure. The computer software system can be run on any of a variety of computing devices, such as a computer (e.g. stationary desktop and/or laptop) and/or a hand-held computing device (e.g. smart-phones such as IPHONE and/or a tablet device such as an IPAD or SURFACE PRO) used within the medical environment. The “medical environment” includes anywhere along the continuum in which patient and medical team (including the doctor, office personnel, nurses, medical technicians, surgeons, administrators) interact, from the surgeon’s office (where the initial consultation and decision for surgery is made) to the operating room (where the surgery takes place). The term may also include personnel involved with post-surgical data collection and/or analysis, such as (but not limited to) (a) insurance companies for the patient, hospital and/or surgeon, (b) state and/or federal agency departments/programs (e.g. Medicare/Medicaid) which reimburse funds to the hospital and/or surgeon, © any other agency (private and/or governmental) which generates payment to the patient, hospital and/or surgeon for the specific surgical case, and/or (d) quality control and/or hospital administration to identify areas of improvement and/or best practices.

“The system and related methods of preventing wrong-site surgeries and blade-related injuries utilize computer software system to support and provide several functionalities, including but not necessarily limited to voice recording, recording playback, an electronic patient-identifying component (such as a patient ID band) capable of being scanned, safety blade-dispenser capable of being scanned, and any of a variety of analytics generated or based upon data acquired through the use of the system from “decision-to-incision”, that is, from the decision to have surgery (made in the surgeon’s office) through the actual surgery (in the OR). Scanning of the patient ID band and/or safety blade-dispenser may be accomplished by scanning functionality of the computer, hand-held device and/or scanning systems separate from the system that cooperate and communicate with the system. The system may use any of a variety of suitable biometric identification technologies (e.g. iris scan, finger-prints, genetics, etc..) in order to identify the patient (and/or the guardian of the patient if the patient is a minor or incapacitated) at any point in the medical environment.

“The safety blade-dispenser includes a variety of scalpel blades for the surgeon to select from in order to perform the first incision of the operation. The safety blade-dispenser (and/or label described below) is color-coded to indicate the laterality of the surgery (e.g. rose or red for “right” sided surgery, lavender for “left” sided surgery, and a neutral color (such as grey) for a surgery with no-laterality). The safety blade-dispenser includes a label with a Q_R code capable of being scanned and linked with patient-data from the patient ID band via the software assembly to create a unique identifier for the particular safety-blade dispenser assigned to the patient during the pre-operative assessment in the hospital after admission on the day of surgery. This unique identifier ensures that the patient receives the correct type of blade-dispenser, meaning the correct laterality of the intended surgery, and can be tracked throughout the remainder of the medical environment and associated with any data captured throughout the entire medical environment to ensure it is correct and used to perform the intended surgery. The label can only be removed from the safety-dispenser after a timeout has been performed by the surgeon or authorized OR personnel. Once the label is removed, the surgeon then and only then has access to a variety of scalpel blades in the blade dispenser, the desired one of which can be safely advanced out of the dispenser for engagement to a handle such that the first incision can be made and the operation commenced.

“The safety blade-dispenser is initially provided sealed in transparent double sterile packaging (which is then placed in a non-sterile container with a transparent window). The transparent packaging/window allows for the identifying information on the confirmation label (e.g. QR code and/or laterality indicator) to be scanned before the safety blade-dispenser is removed from any of the packaging. In this manner, one can avoid the need to have the same identifying information on multiple levels of the packaging. This reduces manufacturing costs and the complexity of matching multiple packaging components to ensure they all have the same identifying information, which would otherwise be required.

“The system of preventing wrong-site surgeries and blade-related injuries allows for tracking of a variety of data from pre-hospitalization to the actual surgical procedure, which the software system can use to generate any of a variety of analytics. The analytics may be based upon, but not necessarily limited to, so-called “near miss” data (that is, errors that were caught and avoided during the use of the system), surgery type and laterality, surgical outcomes, surgical complications, patient demographics, geographic information, as well as the date, time, location and personnel associated with each interaction or use of the system for efficiency and accountability. For example, analytics based on “near miss” data may provide the hospital and/or insurers and/or quality improvement specialists valuable data as to where errors or possible errors may have occurred in order to drive remediation efforts to minimize or avoid such errors in the future. The analytics may also be used to identify best practices based on the data collected, either within the hospital system (“intra-system”) and/or amongst multiple different hospital systems (“inter-system”), and assessed to identify best practices for further reducing wrong-site surgery errors.

“Certain surgeries (including but not limited to spine surgery) can be performed at more than one level or location within a particular organ, structure or region of the patient’s anatomy, which can create challenges for the surgeon to correctly identify the level of the intended surgery. According to one aspect of the disclosure, the system of preventing wrong-site surgeries and blade-related injuries may include a correct site verification process that extends beyond the “Timeout Recorded” step and may be performed before and/or after the time-out is conducted by the surgeon. More specifically, the software is capable of merging and comparing two images (e.g. a pre-op diagnostic image located in the hospital database and a radiographic image taken during surgery or a radiographic image taken during a prior surgery at the same or close surgical location) to determine if the intended site or level is correct.

“The system of the present disclosure may include an additional feature regarding imaging the patient for the intended surgery. More specifically, the software system may allow the surgeon to specify that the patient undergo certain pre-surgical imaging (such as computed tomography (CT), positron emission tomography (PET, etc..) for use in the pre-surgical work-up or clearances as well as during the surgery. For example, the software may be configured such that the surgeon (during the “Decision” stage) may select or toggle a “Imaging Required” option, along with the ability to designate or describe the specific imaging he or she is requesting, which may be saved in the patient’s electronic profile. If imaging is required, this information may be used by the surgery scheduler (at the Scheduling stage) to help schedule the requested imaging. The software may also include related functionality for use as the patient continues through the medical, such as (but not necessarily limited to) providing a selection or toggle an “Imaging Available” option wherein medical personnel (e.g. pre-op personnel) can check the system 10 to ensure the requested imaging is, in fact, available for use by the surgeon in the OR, as well as providing the surgeon the ability to review the imaging, if available, and optionally select or toggle a “Imaging Reviewed” option. Providing the ability for a surgeon to request and review imaging may help safeguard against the possibility that imaging read by other medical professionals (e.g. radiologists) may have been performed or documented inaccurately, which may cause inaccurate information to be in the patient profile. In this case, the surgeon can assess the imaging directly in the OR (or after admission) and determine if any such mistakes were made. If not, the surgery can continue. If so, the surgery can be stopped.”

There is additional summary information. Please visit full patent to read further.”

The claims supplied by the inventors are:

“1-47. (canceled)

“48. A system for preventing or tracking a wrong-site error during a surgical procedure associated with a patient interacting within a medical environment, comprising: a patient-specific article uniquely associated with said patient, said patient-specific article equipped with a machine-readable code containing a unique identification number and a laterality code, said patient-specific article configured for progressing with said patient through said medical environment; an electronic device having a display screen for displaying images, a microphone for creating audio files, a speaker for playing recorded audio files, a processor operable to execute instructions, and a data storage medium for storing instructions; and a computer program product embodied in a non-transitory computer-readable storage medium comprising a set of instructions that, when executed by the processor, are configured to cause the electronic device to: receive surgical planning data that is related to said surgical procedure associated with said patient and that is input by a user, the surgical planning data comprising: (i) an electronic profile for said patient comprising one or more types of data that identifies said patient, the surgical procedure to be performed on said patient, and an indication of procedural laterality; (ii) the unique identification number and the laterality code of said patient-specific article; and (iii)one or more audio files related to said surgical procedure and created using said microphone, at least one audio file comprising recorded patient consent to said surgical procedure; play said audio files relating to said surgical procedure associated with said patient using said speaker; and provide, on said display screen, an interactive presentation that indicates: (i) instructions to conduct an electronically recorded time out to verify patient data and consent prior to starting of said surgical procedure associated with said patient; and (ii) upon receiving indication of a successfully conducted time out, displaying a notification that the verification has been recorded in said electronic profile.

“49. The system of claim 48, wherein said patient-specific article includes storage media comprising said electronic profile for said patient linked to identifying information of said patient-specific article to uniquely associate said patient-specific article and said patient.

“50. The system of claim 48, wherein said patient-specific article comprises a surgical supply carrier having at least one component which prevents or impedes an individual from accessing one or more surgical instruments or components contained therein.

“51. The system of claim 48, wherein said patient-specific article includes a tracking mechanism.

“52. The system of claim 51, wherein said tracking mechanism is an RFID tag.

“53. The system of claim 48, wherein said audio files include a notation describing what procedure is scheduled to be performed on said patient.

“54. The system of claim 48, wherein the instructions, when executed by the processor, further cause the electronic device to display an analysis of transactions that occurred during a time period for which a user interacted within said medical environment.

“55. The system of claim 54, wherein said analysis of transactions includes wrong-site surgery near miss data, wrong-site surgery error data, or combinations thereof.

“56. The system of claim 48, wherein said electronic device is configured to include a decision input indication that said surgical procedure has stopped.

“57. The system of claim 48, wherein said interactive presentation further indicates data associated with an identification of said patient.

“58. The system of claim 48, wherein said interactive presentation further indicates information related to said surgical procedure associated with said patient.

“59. The system of claim 58, wherein said information related to said surgical procedure associated with said patient includes information related to laterality of said surgical procedure required.

“60. The system of claim 59, wherein said information related to laterality of said surgical procedure required is a color coding specific for a left side surgery, a right side surgery, or a neutral surgery.

“61. The system of claim 48, wherein said electronic device includes a camera.

“62. The system of claim 48, wherein said electronic device is configured to scan and interpret optical data.

“63. The system of claim 48, wherein said patient-specific article includes optical data.

“64. The system of claim 63, wherein said optical data is in the form of a bar code or QR code.

“65. The system of claim 48, wherein said electronic device is configured to read biometric data.

“66. The system of claim 65, wherein said biometric data includes fingerprint data, face recognition data, iris recognition data, retina scan data, DNA data, or combinations thereof.

“67. The system of claim 48, wherein said electronic device is configured to track and indicate which users performed a check on said patient as said patient travels within said medical environment.”

URL and more information on this patent application, see: Davis, Christopher; Dentry, Timothy Brian; Kerwood, John G.; Khajavi, Kaveh; Lane, II, David E.; Spangler, Jonathan David. System And Method For Preventing Wrong-Site Surgeries. U.S. Patent Application Number 20230210555, filed August 3, 2022 and posted July 6, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230210555)&db=US-PGPUB&type=ids

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