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Número de publicaciónWO2006039752 A1
Tipo de publicaciónSolicitud
Número de solicitudPCT/AU2005/001575
Fecha de publicación20 Abr 2006
Fecha de presentación11 Oct 2005
Fecha de prioridad11 Oct 2004
Número de publicaciónPCT/2005/1575, PCT/AU/2005/001575, PCT/AU/2005/01575, PCT/AU/5/001575, PCT/AU/5/01575, PCT/AU2005/001575, PCT/AU2005/01575, PCT/AU2005001575, PCT/AU200501575, PCT/AU5/001575, PCT/AU5/01575, PCT/AU5001575, PCT/AU501575, WO 2006/039752 A1, WO 2006039752 A1, WO 2006039752A1, WO-A1-2006039752, WO2006/039752A1, WO2006039752 A1, WO2006039752A1
InventoresKen Hillman
SolicitanteNewsouth Innovations Pty Limited
Exportar citaBiBTeX, EndNote, RefMan
Enlaces externos:  Patentscope, Espacenet
A patient safety system
WO 2006039752 A1
Resumen
A method, an apparatus (100), and a computer program product are disclosed for monitoring patient safety. In the method, signals (120) regarding the physiological condition of two or more patients (140) are transmitted wirelessly. The information of the transmitted signals is aggregated at a remote location relative to the two or more patients (100).
Reclamaciones  (El texto procesado por OCR puede contener errores)
CLAIMS The claims defining the invention are as follows:
1. A method of monitoring patient safety, said method comprising the steps of: transmitting signals regarding the physiological or observational condition of two or more patients; and aggregating the information of said transmitted signals at a remote location relative to the two or more patients.
2. The method according to claim 1, further comprising the step of generating an alert if the aggregated information of at least one of the two or more patients satisfies a threshold condition for said alert.
3. The method according to claim 2, further comprising the step of transmitting said alert for action by appropriate personnel.
4. The method according to claim 2, further comprising the step of recording said alert in printed or electronic form.
5. The method according to claim 1, further comprising the step of integrating said aggregated information with other information from other sources.
6. The method according to claim 1, wherein said other information includes at least one of deaths, cardiac arrests, unplanned admissions to the ICU or other adverse events, individual clinicians, wards & clinical teams, length of stay (LOS), diagnostic groups, admission and discharge from hospital, source of admission, insurance status, patients made not for resuscitation (NFR), and patients discharged from ICUs or other specialised parts of hospital.
7. The method according to claim 1, further comprising the step of generating said signals regarding the physiological or observational condition of two or more patients using a portable monitoring device attached to each respective patient.
8. The method according to claim 1, wherein said signals regarding physiological or observational condition comprise information about one or more of pulse rate, respiration rate, ECG, blood pressure, temperature, oxygen saturation, and the like.
9. A system for monitoring patient safety, said system comprising: a portable device for transmitting signals regarding the physiological or observational condition of two or more patients; and means for aggregating the information of said transmitted signals at a remote location relative to the two or more patients.
10. The system according to claim 9, further comprising means for generating an alert if the aggregated information of at least one of the two or more patients satisfies a threshold condition for said alert.
11. The system according to claim 10, further comprising means for transmitting said alert for action by appropriate personnel.
12. The system according to claim 10, further comprising means for recording said alert in printed or electronic form.
13. The system according to claim 9, further comprising means for integrating said aggregated information with other information from other sources.
14. The system according to claim 9, wherein said other information includes at least one of deaths, cardiac arrests, unplanned admissions to the ICU or other adverse events, individual clinicians, wards & clinical teams, length of stay (LOS), diagnostic groups, admission and discharge from hospital, source of admission, insurance status, patients made not for resuscitation (NFR), and patients discharged from ICUs or other specialised parts of hospital.
15. The system according to claim 9, further comprising means for generating said signals regarding the physiological condition of two or more patients using a portable monitoring device attached to each respective patient.
16. The system according to claim 9, wherein said signals regarding physiological condition comprise information about one or more of pulse rate, respiration rate, ECG, blood pressure, temperature, oxygen saturation, and the like.
17. The system can be used to record signals generated from patients and retrospectively analyse the generated data in order to improve patient safety across the organisation.
Descripción  (El texto procesado por OCR puede contener errores)

A PATIENT SAFETY SYSTEM

TECHNICAL FIELD

The present invention relates generally to medical systems and devices and in particular to a system for monitoring the condition of patients in a hospital, other medical facility, aged care facility, or the like.

BACKGROUND In hospitals and other care facilities involving medical services, nursing staff directly observe vital signs and deal with urgent patient safety issues. This type of activity is time consuming and inefficient. Such activity also misses many potential antecedents to deaths and serious complications, as a result of limited staff numbers, unskilled staff, and the low frequency of observations. For example, in a general hospital ward, the maximum observation frequency might be hourly for the most at-risk patients. /Such measurements are often made every six hours or so, but patients may decline quickly in such long intervals between observations. A recent study demonstrated less than half of all potentially at-risk patients had vital signs measured by nursing staff

Apart from cardiac arrest teams, medical facilities lack a universal and systematic way to respond to hospital emergencies. Studies have shown typical responses are late and almost universally inadequate. Excluding emergency rooms, intensive care, high dependency units, and operating theatres, many hospital wards provide inappropriate care for all increasingly at-risk population of patients and lack an automated, quick connection to medical emergency teams and other such rapid response teams.

Currently, there is an abundance of data and information systems in hospitals, but little in terms of validated, standardised and easily accessible information on patient safety. Currently, outcome indicators based on adverse events occurring in medical facilities are collected and analysed in a non-standardised, ad-hoc fashion.

Thus, a need clearly exists for a system of monitoring patients to provide rapid and useful patient safety information to an entire organisation; as well as a hospital-wide system for the early detection of a rapid response to severely ill patients. SUMMARY

In accordance with an aspect of the invention, there is provided a method of guaranteeing patient safety. The method comprises the steps of: transmitting wirelessly signals regarding the physiological and observational condition of two or more patients; 5 and aggregating the information of the transmitted signals at a remote location relative to the two or more patients.

The method may further comprise the step of generating an alert if the aggregated information of at least one of the two or more patients satisfies a threshold I0 condition for the alert.

The method may further comprise the step of transmitting the alert for action by appropriate personnel.

is The method may further comprise the step of recording the alert in printed or electronic form.

The method may further comprise comprising the step of integrating the aggregated information with other information from other sources.

20

The other information may include at least one of deaths, cardiac arrests, unplanned admissions to the ICU or other serious adverse events, individual clinicians, wards & clinical teams, length of stay (LOS), diagnostic groups, admission and discharge from hospital, source of admission, insurance status, patients made not for resuscitation 2S (NFR), and patients discharged from ICUs or other specialised parts of hospital.

The signals transmitted from patients maybe recorded and used retrospectively analyse the events which could have contributed to adverse patient events.

3o The method may further comprise the step of generating the signals regarding the physiological and observational condition of two or more patients using a monitoring device attached to each respective patient. The signals regarding physiological and observational condition may comprise information about one or more of pulse rate, respiration rate, ECG, blood pressure, temperature, oxygen saturation, and the like.

In accordance with another aspect of the invention, there is provided a system for monitoring patient safety. The system comprises: a device for transmitting wirelessly signals regarding the physiological or observational condition of two or more patients; and means for aggregating the information of the transmitted signals at a remote location relative to the two or more patients.

The system may further comprise means for generating an alert if the aggregated information of at least one of the two or more patients satisfies a threshold condition for the alert.

The system may further comprise means for transmitting the alert for action by appropriate personnel.

The system may further comprise means for recording the alert in printed or electronic form.

The system may further comprise means for integrating the aggregated information with other information from other sources.

The other information may include at least one of deaths, cardiac arrests, unplanned admissions to the ICU or other adverse serious events, individual clinicians, wards & clinical teams, length of stay (LOS), diagnostic groups, admission and discharge from hospital, source of admission, insurance status, patients made not for resuscitation (NFR), and patients discharged from ICUs or other specialised parts of hospital.

The signals transmitted from patients maybe recorded and retrospectively used to analyse the events which could have contributed to the adverse patients outcome. The system may further comprise means for generating the signals regarding the physiological or observational condition of two or more patients using a portable monitoring device attached to each respective patient.

The signals regarding physiological or observational condition may comprise information about one or more of pulse rate, respiration rate, ECG, blood pressure, temperature, oxygen saturation, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the invention are described hereinafter with reference to the drawings, in which:

Fig. 1 is a block diagram of a patient safety system in accordance with an embodiment of the invention;

Fig. 2 is a block diagram illustrating central data units providing data to a hospital patient information system;

Fig. 3 is a flow diagram of processing performed by a central data unit;

Fig. 4 is a block diagram of a central data unit in accordance with an embodiment of the invention;

Fig. 5 is a block diagram illustrating the monitoring of a patient in accordance with an embodiment of the invention;

Fig. 6 is a block diagram of the overall system of a patient safety system in accordance with an embodiment of the invention;

Fig. 7 graphically depicts monitoring of a patient in accordance with embodiments of the invention; and

Fig. 8 further illustrates monitoring of a patient and wireless transmission of patient data to the central data unit for further processing. DETAILED DESCRIPTION

With the system according to an embodiment of the invention, data on clinical status, including patient safety, is electronically collected directly from the patient, stored, analysed and targeted to all levels of the organisation, informing around individual and aggregated clinical and patient safety trends.

The Medical Emergency Team (MET) system on which the embodiments of the invention is based involves immediate response by a trained team to resuscitate at-risk patients before those patients die, have a cardiac arrest, require admission to an Intensive Care Unit or suffer other serious adverse events. A patient monitoring system in accordance with embodiments of the invention is driven by patient signals and provides rapid and useful patient safety to the entire organisation of a hospital. This can maximise awareness of patient safety issues and facilitate change to improve patient outcome. Thus, the embodiments of the invention seek to provide a universal patient safety system for use in hospitals, other medical facilities, aged care facilities, and the like, providing real-time patient adverse-event monitoring with rapid appropriate emergency response. The system also provides the basis for a standardised review of patient safety across the facility. The embodiments of the invention process and deal with the data to provide a hospital- wide system aimed at improving and monitoring patient safety.

The system is aimed at enhancing patient safety across currently unmonitored or inappropriately monitored general ward patients as well as other environments where universal monitoring does not occur, e.g. Emergency Departments (ED).

The system incorporates an individually tailored and tiered response, is the basis for monitoring and evaluating patient safety across the hospital; and provides hard copy vital sign recordings for clinical notes or for incorporation into electronic patient records. It also provides a basis for decision making in areas such as discharge planning.

Fig. 1 is a block diagram of a patient safety system 100 in accordance with an embodiment of the invention. This system 100 analyses and targets information throughout an organisation as a major patient safety tool. This involves universal patient monitoring and appropriate patient safety responses pursuant to that monitoring. As depicted symbolically in Fig. 1, a patient 140 is provided with a monitoring device 134 which could operate in a wireless mode for measuring physiological parameters of the patient. The patient monitoring unit 134 may comprise a small portable wireless monitor, with a plug in bedside monitor and an optional observational module 130. The device 134 may comprise small patches that can be attached to the chest for the measurement of pulse rate and respiratory rate. These may be connected to the patient via cuff devices attached around the arm, for example, in order to measure vital signs such as blood pressure. Alternatively some other form of attachment enabling the patient to be ambulant and free of connection using wireless technology. Adjustable alarm limits may be specified for the monitoring device 134. A number of physiological conditions are continuously monitored or intermittently monitored by the wireless device 134. These include pulse rate (PR), respiratory rate (RR), and ECG (optional) 126. In addition, blood pressure, temperature and oxygen saturation 128 may be monitored. These usually require the patient to be connected to a device beside their bed or chair. However, wireless technology can be used for these signals. As well as direct monitoring, the system allows for nursing or other clinical observation to be integrated into the system using an observational module 130. For example, the presence of seizures, coma, obstructed airway and decreased urine output (oliguria) are usually observable rather than measured phenomenon. Attending staff can alert their "concern" and need for assistance through the same system; see observational module in Fig 1. From observational module 130, an NFR or NF MET condition may be specified 132. Patients are often declared not for resuscitation (NFR) or not for a MET response (NFMET). The module 130 may override the system based on this information may be integrated as it may be inappropriate to consider further active management in such patients.

The foregoing various parameters may be measured continuously or intermittently as appropriate. These are provided as one or more signals 120 that are transmitted wirelessly to a central data unit (CDU) 119 to provide information 112 in accordance with the embodiment of the invention. The monitoring device 134 may itself incorporate a wireless communications mechanism internally, or may be connected to an external wireless communications mechanism. The signals 120 may be used as an alert mechanism for patient safety, be recorded as the basis for quality control, and be recorded as the basis for monitoring of processes such as trends in work load. The signals are provided to the CDU 119, which receives, analyses and stores data. The CDU 119 also stores algorithms for processing the data and sends information and is interrogated by an hospital information system (HIS) 108/109. Further, an alert 118 may be generated in specified circumstances in which case a medical emergency team 116 is notified. The MET alert limits can be adjusted individually for each patient, ward, or hospital. The alarm limits may be around pre-defined levels of pulse rate, respiratory rate and blood pressure as well as observational characteristics which correspond to existing published MET criteria . Moreover different combinations of these signals may enable a tiered response to patients. This may include also notifying a Medical Emergency Team, specified members of the medical team caring for the patient, a more senior nurse, or a more appropriate range of personnel. The MET team or the like may provide a locally determined tiered response to the patient in appropriate circumstances. The locally designated alarm limits determine response options. For example, a sudden drop in level of consciousness (GCS <2), seizures, obstructed airway, pulse rate of more than 120 beats/minute or less than 40 beats/minute, a respiratory rate of less than 4/minute or more than 30/minute, and a blood pressure of less than 90 mmHg could be established as mandatory MET response criteria. Variations to the foregoing may be made without departing from the scope and spirit of the invention. Algorithms around these values may also be specifically employed. A lower level of tiered response (eg other medical staff, more senior nurse, etc.) is possible to match each hospital's needs. The alert signal system 118 may have algorithms to identify patients who require a different level of care. This could either be preset and automated, or left to the discretionary decision of the home medical team or more senior nurse. The signal could, also be directly accessed by, and transmitted to, the clinician in charge of the patient using existing available technology.

The CDU 119 is coupled to a monitor 121 that provides an auditory and/or visual display. The CDU 119 may also provide clinical notes 123.

The information 112 derived from the transmitted wireless signals 120 can be integrated with other hospital data 110, which includes deaths, cardiac arrests, ICU Admissions, length of stay (LOS), early discharge from ICU/CCU, admission to ward from Emergency Department, and NFR/NFF MET. The information 112 and the integrated other information 110 may be used to provide standardised hospital information on patient safety, including: near misses, potentially preventable adverse events, adverse events, and stable patient/staged discharge. The information 112 derived from the patient signal can be integrated with hospital administrative databases, including patient demographic and flow information. The information 112 can also be integrated with existing quality assurance databases and data on serious adverse events, including deaths, cardiac arrests and unplanned admissions from the Intensive Care Unit.

The information 112 is provided and obtained from a quality assurance module 108 (e.g., alerts, near misses, potentially patient adverse events, adverse events) and workplace process information module 109 (e.g. discharge planning, complexity and workload) in the hospital information system (HIS). Specifically formatted and targeted information 106 on hospital activity is disseminated to all levels of the organization.

Because of NFRNFMET orders (i.e. not suitable for active resuscitation measures), these override all signals informing the staff that all signals need to be considered with this in mind.

The system 100 provides universal monitoring of patients in all wards of a hospital. Each patient is provided a small monitoring device 134 capable of continuously and/or intermittently measuring physiological parameters. Minimum universal monitoring includes pulse rate and respiratory rate. For example, the device 134 may continuously measure the patient's pulse and respiratory rate 126. The monitoring device 134 may provide or be coupled to a device capable of providing wireless communications including GPRS, WiFi, other IEEE 802.11 wireless protocols, or the like. Amongst other things, this permits patients to be ambulatory. The sampled signals obtained by the monitoring device 134 may be generated rapidly, effectively and continuously in comparison to manual collection of such data.

Predefined patients may also have non-invasive blood pressure, temperature, ECG and oxygen saturation measured 128. Non-invasive blood pressure may be measured intermittently at predetermined intervals. Temperature may be measured intermittently or continuously. Oxygen saturation and ECG may be measured continuously. All signals are transmitted to the Centralised Data Unit (CDU) 119 at a centralised point in local wards.

A bed side alarm pad also may be connected with call buttons for various potentially dangerous clinical circumstances including a drop in level of consciousness, potential obstruction to the airway, cardiorespiratory arrest and general concern by any staff member around a patient's condition. Clinical staff can activate the device 130 at any time to summon immediate assistance. Staff may be encouraged to activate the device if the staff member felt the patient's condition had seriously deteriorated, and urgent assistance was required. The signal alert range may be individually configured for each patient, ward, and/or hospital. Some patients may be outside the normal limits of considered danger without suffering any adverse event. For this minority of patients, the alarm limits could be individually adjusted. Similarly, wards and/or hospital have different levels of infrastructure and support necessitating an adjustable response.

The system 100 also ensures appropriate patient safety responses. A CDU 119 sited in each ward provides a flexible and specifically configured alert system 118 for a tiered response to the patient signal, including immediate summoning of an emergency team, immediate notification of the medical home team, and/or alerting a more senior member of the ward's nursing staff or other appropriate staff. The CDU 119 also provides a hard copy of patients' vital signs 123 to be inserted into the patient's clinical notes and as a basis for reviewing adverse events (i.e. in the same way as an airplane "blackbox" after serious accidents). Alternatively, the signal could be incorporated as part of the patient's electronic record.

In the system 100, the monitoring signals provide the basis for standardised hospital information (evaluation) including hospital patient safety and work place processes such as discharge planning workforce and capacity issues, including:

(a) MET CALLS AND OTHER ALERTS. The signal records all ALERTS and at what tier the alert was as outlined below: i.e. MET CALL - For urgent, potentially life-threatening situations. Home team - This calls to a member of the admitting medical team staff for a problem with less urgency than a MET call.

Senior nursing staff- This would be a more junior nurse alerting a more senior nurse about a lower level problem with little urgency. Other response - Facilities for alerting other appropriate staff are available.

Senior medical staff access - There is the potential for senior medical staff to be made aware of urgent responses to one of his/her patients using wireless/remote technology. Access is also available on patient status and trends using signal information.

Information from other sources may be integrated into signal data and provide: Patient details, Site of response, and Antecedents to the response. For quality assurance purposes other data may be integrated into the signal including: What interventions occurred at the time of the response; What was the outcome of the patient and where were the patient transferred to, and Who attended the intervention.

(b) NEAR MISSES- Provides information on patients who fall outside of acceptable limits on vital signs but where no obvious adverse event occurred. This involves antecedents with no adverse event. The antecedents to adverse events (adverse outcomes) include a recording. They enable a retrospective review of measurements and observations that were considered likely to lead to an adverse event but in this case, did not. This information can be used in the Quality Assurance context to gain insight and understanding of the hospital's patient safety system.

(c) POTENTIALLY PREVENTABLE ADVERSE EVENTS- Includes serious adverse events such as unplanned admissions to the Intensive Care Unit, as well as unexpected deaths and cardiac arrests. These are defined as events in patients who are considered potentially salvageable (i.e. without an explicit "NOT FOR RESUSCITATION (NFR)" or "DO NOT RESUSCITATE ORDER" (DNR) written in the clinical notes). The hospital is to investigate what went wrong in these patients and the investigation relies on the information from the patient signal. This involves antecedents with no action.

The purpose of the measurements and observations (antecedents) is to provide early s warning of patients likely to have an adverse event so that an appropriate intervention can occur early. If these are ignored by the system, investigation is necessary to analyse where the system failed and how it could be improved, using the analogy of analysis of the "black box" after an airplane crash. For example, if a patient who had a cardiac arrest had a pulse rate outside the safe zone (antecedent) for 4 hours preceding the arrest, an o analysis of why an appropriate alert and response did not occur must be undertaken. Similar analyses are possible to retrospectively analyse other adverse events.

(d) ADVERSE EVENTS- Includes the three adverse events unexpected deaths and cardiac arrests, and unplanned admissions to ICU as well as other serious adverse events, s where appropriate action has occurred. This information may be used to learn from analysing why systems worked, in contrast to why they may not. In the areas of quality assurance, it is sometimes just as important to analyse serious adverse events when there was no obvious element of preventability. For example, it may be related to a patient who has a sudden cardiac arrest on the ward with little or no warning signs (i.e. 0 abnormalities in the patient's signal).

WORKPLACE PROCESS INFORMATION 109. This information would include:

(a) DISCHARGING PATIENTS SAFELY- Provides the basis for 5 making a decision for safe patient discharge from hospital. Currently this is achieved by specialists visiting patients sporadically and examining vital sign charts at the end of the patient's bed and looking for trends indicating improvement.

The signal trend could be used by clinicians in charge of the patient o for reviewing stability in the patient's measurements and observations as a basis for concluding that the treatment has worked and the patient is suitable for discharge. This may be achieved by the consultant in charge of patient care using remote technology. Similarly the organisation may use the signal to audit stability in - In ¬

patient measurements and observations as a tool for reviewing delayed hospital discharge and the reasons for it.

(b) Complexity and workload information. The aggregated information from the hospital CDUs may also be used to monitor trends in workplace process issues. For example the complexity of patients in various parts of the hospital may change as reflected by the vital sign information and the number of alerts and observational signals. As the nature of interventions and character of the patient population changes, the vital signs may move further to extremes away from previous averages. Moreover, the number of "alerts" and observation calls may increase. This would be analysed and interpreted, for example, in terms of changing levels of complexity of patients or lack of adequate capacity in wards to care for the changed level of complexity in patients.

HOSPITAL ADMINISTRATION AND OTHER QUALITY ASSURANCE DATA

110

This data would come from other organisational sources and merged with the new hospital-wide system in order to provide standard Quality Assurance and workplace process information. This data may include:

Patient demographics and specific patient identification,

Date of admission and discharge from hospital, Emergency or elective admission,

Invasive and non-invasive procedures; laboratory information; diagnostic tests; medications,

Diagnostic categories, " Treatment limitations, Insurance status,

■ Complaints,

■ Adverse events,

■ Admission and discharge dates from specialised hospital areas, eg ICU, HDU, CCU, Death, and

Unplanned admission to ICU.

DISSEMINATION OF INFORMATION ON PATIENT SAFETY AND s WORKPLACE PROCESS ISSUES 106

The information from the CDU 119 may be integrated with other hospital information to form a framework for hospital quality assurance 108 and workplace process activities 109 as described above.

o This information may then be analysed and targeted in an appropriate format to all levels of the organisation in order to monitor activities of the organisation in a standardised fashion, as well as empowering all levels of the organisation with relevant information to enable them to understand, control and, if necessary, change their particular component of the organisation. It would also provide higher levels of the organisation a broad picture s and trends related to quality assurance and workplace issues.

Fig. 2 provides further details of the hospital information (HIS) system 200 and workplace process issues. A number of CDUs 310, 312, 314, 316, 318, 320 are coupled to the HIS 200 comprising a quality assurance module 220 and workplace process 0 information module 222. Hospital administration and other quality assurance data 224 may be integrated with the data from the CDUs. The HIS 200 produces formatted information 210 targeted at all levels of the organization.

With reference to Fig. 4, the CDU 119 also receives information on the resuscitation 5 status 420 of the patient to override predetermined signal alerts where it is not appropriate to take aggressive action.

The CDU 119 receives stores and analyses data 120, as well as holds algorithms for processing such data. The CDU system provides a predetermined alert system (114, 116, o 118). The CDU system 119 drives hard copy printout of predetermined measurements and observations for each patient to be incorporated into their clinical notes 123 (eg for each nurses shift period) or alternatively provides the same information to be integrated into the patient's electronic record. A monitor 121 in Fig 4 provides selected patient auditory and/or visual display. The CDU 119 produces data for the aggregated patient information ofthe HIS 410.

The CDU system 119 has the capacity for analysing trends in the patient's condition as a s predictor of need for increased level of care and even decreased level of care. This can be considered as part of the ALERT system.

Again, the CDU system 119 provides information for the hospital information system 410. The hospital information system 410 has the ability to interrogate the CDUs 119. o An algorithm is used to provide an alert system.

The data in the CDU 310-320, 119 is used to inform the hospital on aspects of quality and patient safety as well as workplace process information. These aspects include:

• analysing patient information before serious adverse events, s • analysing patterns in patient safety across wards,

• performance of various medical and nursing teams, variations with seasons/times of day, etc.

• analysing trends in complexity and associated workload associated with measurement and observational data together with patient safety performance, 0 • near misses- analysing antecedents that may be potentially dangerous but without a serious adverse event,

• potentially preventable adverse events, such as deaths, cardiac arrests and other serious complications such as unplanned admission to the ICU, where antecedents to the event were recorded but where inappropriate or inadequate 5 response occurred, and

• adverse events with appropriate response - serious adverse events always occur in acute hospitals. The data from the central data unit informs analysis of those events.

• The CDU 119 provides information to the hospital system and the hospital system o is able to interrogate the CDU.

Information from CDUs 310-320, 119 is integrated with other hospital data sources 110 in Fig. 4, including: • INTEGRATION OF HOSPITAL ADMINISTRATIVE DATABASE e.g.

Patient demographics and unique identification number,

Admission and discharge dates, Source of admission - emergency or elective,

Insurance status,

■ Admission and discharge dates from specialised hospital areas, eg ICU, HDU, CCU,

Dignostic categories, and Invasive and non-invasive procedures; laboratory information; diagnostic tests; medications

• INTEGRATION OF OTHER HOSPITAL QUALITY ASSURANCE DATABASES e.g.

Morbidity and mortality data, Deaths,

Cardiac arrests,

Unplanned ICU admissions,

NFR/NFMET status,

Complaints, and Other serious adverse events.

Fig. 2 shows such CDUs 310-320 providing information to the hospital information system 200. In a hospital environment, each ward may have such a CDU 310-320. The information is analysed and formatted to maximise understanding of the hospital's strengths and weaknesses. The information can be targeted to all levels of the organisation to maximise understanding and facilitating change. For example, weekly data on all patient alerts and their outcome may be provided to each ward, together with adverse events (unexpected deaths and cardiac arrests and unplanned ICU admissions) which were potentially preventable (i.e. they were preceded by measurement and observational abnormalities which were not appropriately acted on). Pattems of adverse events across the hospital may also be analysed within the HIS. For example, there may be an unusually high number of adverse events associated with certain wards; medical or nursing teams; times of day or times of year.

Fig. 3 is a flow diagram of the operation of the CDU 119. In step 310, signals are received, analysed and stored. The signals include all measurement signals (pulse rate, respiratory rate, ECG, blood pressure, temperature, oxygen saturation) as well as observational signals (seizures, decrease in level of consciousness, airway threatened, oliguria, cardiorespiratory arrest, and "concern"). In step 312, the received data is displayed as necessary and in step 314, the data may be printed or become part of an electronic patient record. Analyses may also be displayed visually and/or with auditory alarm. The CDU 119 may generate an immediate team response and/or a tiered response. The CDU alerts patient's status (e.g. NFR), provides hard copy patient monitoring, monitors trends for determining level of care, and drives hospital patient safety or work force needs.

Fig. 4 is a block diagram of a central data unit 119, which includes a monitor 121. The monitor 121 may provide monitored data on demand or provide an alarm. A data analysing and storage unit of the CDU 119 is coupled to the display 121 and the CDU 119 has a wireless receiver for receiving wireless communications from the portable monitoring device 134 attached to each patient. The data analysing and storage unit may be coupled to an output device 123 that is able to print out data for hard copy clinical notes or alternatively become integrated as part of an electronic patient record.

The CDU 119 may receive, store and analyse patient signal data and using specific software to convert this data into: o Monitor - visual display/auditory alarm as needed. o Printer to be incorporated into patient notes or part electronic record. o Alert system - adjustable and tiered to specified levels for that ward. o Provide information to, and be interrogated by, the Hospital Information

System. Fig. 5 is a system diagram illustrating the monitoring process 500 graphically. The patient 510 is monitored in situ (e.g., a hospital bed) and parameters such as pulse rate and respiratory rate 520, blood pressure and temperature and oxygen saturation 522 are obtained. An observational module 524 may also be provided. For the pulse rate and respiratory rate 520, this may be sampled continuously as is the case for oxygen saturation 522, but the blood pressure and temperature measurements 522 are usually performed intermittently. The output is the minimal universal vital sign data set 530 that is used to generate the wireless signal 534 transmitted to the central data unit 540 (e.g., in the relevant ward). The blood pressure, temperature, and oxygen saturation 522 becomes part of the non-ambulatory signal 531 which may be discretionary. This signal 535 is also transmitted to the CDU 540. The observational module 524 relates mainly to nursing or attending clinical staff direct observation of the patient and this is almost always intermittent. Abnormal observations include seizures, compromise of the airway, decrease in level of consciousness, cardiorespiratory arrest, or "concern" 532. This signal 536 may also be transmitted to the CDU 540 either wirelessly or tiered wired.

Fig. 6 is a flow diagram illustrating the overall system 600. The patient 610 is monitored in the ward using the wireless device 620 which makes a wireless or hard wired transmission to the central data unit 630. The central data unit 630 may provide a number of functions including urgent response, monitoring, tiered/tailored response, status printing, and vital signs for adjusting the level of care. This can then be transmitted to a hospital information system 640, which may provide:

Quality assurance information including all alerts, near misses, Potentially Preventable Adverse Events, And Safety Trends Across Hospitals. ■ Workplace Process Issues including o Patient complexity and workload information, eg on the trends in nature of patient measurements and observations reflecting patient complexity and indirectly, workload as well as trends in adverse events, o Discharge appropriateness - trends in patient measurements and observations give information on patient stability and suitability for discharge. This can be used for audit or operational purposes.

■ Ability to interrogate CDUs to provide above information. Fig. 7 is a schematic diagram graphically illustrating monitoring 700 of a patient in greater detail. The patient 710 may have pulse rate and respiratory rate monitored using appropriate sensors. These parameters are monitored using simple disposable leads attached to the patient, eg arm or belt device with leads going to chest wall. The monitored parameters are and then transmitted by wireless transmission. Further, the patient 720 may have a non-invasive blood pressure recorder and again this can be transmitted either wirelessly or hard wired. Still further, pulse oximeter and/or temperature may be measured as shown with the patient 730. A bedside alarm pad 740 may indicate consciousness level drop, airway threatened, seizures, cardiorespiratory arrests and other concerns and be transmitted by wireless transmission or hard wired as well.

Fig. 8 is a high level block diagram illustrating a patient being monitored 810 with an accompanying alarm pad 812 in proximity to a ward bed and being suitably adapted for wireless transmissions 814 better received by a wireless receiver 820 coupled to a central data unit 822 in the ward. The central data unit 822 (dependent upon the data) may provide an urgent code immediate response 830, a tiered and tailored response 832 if less urgent (e.g. lower or higher level of care decision) and may print out a hard copy or electronic record 834. Further, this data can be provided to the hospital patient information system 840. Also, an output may be provided to a monitor 835 from the CDU 822.

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Clasificaciones
Clasificación internacionalG06Q50/00, A61B5/00
Clasificación cooperativaA61B5/002, G06F19/3418
Clasificación europeaG06F19/34C, A61B5/00B
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