20190516_Patient_monitoring_SOW.docx

Patient Monitoring (Telemetry) Statement of Work

1. Introduction: The 88th Medical Treatment Facility (MTF) located at Wright-Patterson AFB, OH requires a hospital wide patient monitoring solution.

2. Background: WPMC currently utilizes an antiquated patient monitoring system.

3. Delivery Date: 180 days after contract award (initial installation should begin 16 weeks after award)

4. Building address:

ATTN: MEMO – SSgt Demadra Humphrey

5. Government Minimum Requirements:

The scope of this Statement of Work is for a complete turnkey solution for a patient monitoring system at Wright Patterson AFB. The requirement includes all equipment, mounting components, interface components, infrastructure components, and materials, installation, and training necessary to operate the system and engineering.

Departments that require continuous patient monitoring in this request for offer are: Emergency Room, ICU, ICU Stepdown, Operating Room, Ambulatory Procedure Unit/Post Anesthesia Care Unit, Gastrointestinal Department, Bronchoscopy Suite, Multi Service Unit, Cardiology and Pain Management Clinic. Telemetry coverage is required for the same units and all adjacent corridors utilized for patient transport.

6. System characteristics:

1. The Patient Monitoring System must provide continuous monitoring of patients at bedside and on cardiac telemetry through a facility-wide infrastructure (Wi-Fi or Wireless Medical Telemetry Service (WMTS)) compatible with the Air Force Network. Current support requirements is for a 57 inpatient bed facility, with the capability to expand coverage as needed.

2. The contractor must provide any software and hardware upgrades required for functionality of installed equipment and for RMF (Risk Management Framework) on the DOD cyber network during the life expectancy of 7-10 years.

3. There are two main components to the system:

a. A bedside monitoring suite: services multiple units via a central server that provides display, communication, and processing for patient physiological data with recording capability from any monitor in the facility. The bedside monitor suite encompasses the ICU (Intensive Care Unit), and ICU-Stepdown Units, Operating Room (OR), Emergency Room (ER), Ambulatory Procedure Unit/Post Anesthesia Care Unit, and Gastroenterology Department (GI), Pain Management Clinic, Family Birthing, and the Bronchoscopy Suite. *See flow sheet for totals*

b. The second component is a cardiac telemetry system that also provides a record capability of patient data and waveforms utilizing wearable telemetry packs that transmit ECG and SPO2 philological data over a network (Wi-Fi or WMTS) to a central monitoring server for viewing and analysis.

4. All bedside patient monitors are required to be viewed and manipulated from three central stations located in: ER, ICU, and PACU/APU. Capability to record physiological data up to 72 hours per patient is required.

5. A central telemetry station must be installed in the ICU to allow flexible monitoring from all areas within the hospital. The central telemetry station and viewing station displays must be a 20” wide at a minimum with an adjustable font size and touch screen interface.

6. Additional cardiac telemetry viewing stations must be provided and installed in the MSU (Multi Service Unit) second and third floor, and in the cardiology clinic, ICU, and ICU Step-Down unit.

7. A viewing station for the OR will be located in the Anesthesia office.

8. For ICU and ICU Stepdown units, the system must be have capability to display and record the following parameters and waveforms: SpO2 pulse oximetry, EtCO2 capnography, ECG 5 Lead, ECG 12 lead, temperature (all types), NBP with MAP. The monitor must also have a pressure transducer monitoring capability encompassing: hemodynamic arterial and venous line with cardiac output measurement, and internal cranial pressure with CPP, and a generic data field for flexible monitoring of pressure. Three pressure line cable ports must be available. Two temperature line ports are also required. Capability of the monitor to provide thoracic impedance non-invasive hemodynamic monitoring, Bispectral Index (BIS) monitoring and train of four control is requested for quote. Sepsis protocol software must be loaded and utilized on all ICU monitors. Minimum screen size is 19 inches with touch screen interface.

9. OR monitors must be compatible with Drager Fabius GS and GE Avance anesthesia machines. Units must mount to the machine and interface to Innovian software. The monitor must record for 24 hours per patient while also providing continuous data feed to Innovian. A minimum of two ECG waveforms must be available for display simultaneously. A thermal printer should be attached for ECG strip printout. All interface hardware, mounting hardware, cables, software, and licensing will be included in the quote.

10. OR monitors must display all ICU minimum parameters plus: Gas analyzer outputs displaying inspiratory and expiratory O2, CO2, N2O, sevoflurane(C4H3F7O), isoflurane (C3H2ClF5O), and desflurane (C3H2F6O). Gas analyzer outputs should be calculated into a Minimum Alveolar Concentration (MAC) and be available for display on the screen. CO2 readings must be available in mmHg.

11. OR monitors (one screen on every machine) must also provide means to serve as an interface for train of four control and bispectral index (BIS) readout. Minimum screen size is 19 inches with touchscreen interface.

12. ER, GI, APU/PACU, Pain Management, Family Birthing, and the Bronchoscopy Suite: systems must be have capability to display and record the following parameters and waveforms: SpO2 pulse oximetry, EtCO2 capnography, ECG 5 Lead, ECG 12 lead, and NBP with MAP. Note: PACU bays must have at least one a pressure line port available for arterial line monitoring. Minimum screen size is 15 inches with touchscreen interface.

13. All data fields for patient monitoring must be available for selection and display on the monitor and on the central system.

14. All bedside monitors must incorporate Early Warning Scoring software.

15. All bedside monitors must also have patient age calibration for adult, pediatric, and neonates.

16. Vitals data with waveforms and parameters must be stored and retrievable for up to 72 hours for trend data and event history analysis for all units.

17. The bedside monitors, central monitoring stations, and servers must include a battery backup system capable of running the system for 30 minutes in the event of facility power loss.

18. The cardiac telemetry system must have post-discharge full disclosure, advanced telemetry monitor tools; calipers, annotation, and ECG strip export capability.

19. The patient monitoring system must communicate with the facility electronic medical records system (currently Essentris, CHCS and AHLTA) via the installed CliniComp HL7 interface and be adaptable to new EMRs at no cost to the government.

Minimum Unit Requirement Flow Sheet

Down

Gas analyzer readout w/MAC

X

Min 15” screen

X

X

20. The system is required to be capable of capturing physiological data when a patient is connected to the system and having that patient information available to central and viewing stations wherever they may be in the facility. The coverage of the system must extend to all patient care and diagnostic areas including all corridors where patient transport is conducted.

21. Patients must be linked to their monitor packs once admitted to the central system and will remain identified on the system through that pack unless discharged from the system. Ability to transfer patients and their data from room/bed assignment to another room/bed/unit/department without loss of that data must be available.

22. If a patient is transferred to another monitor pack, a capability to link their previous data from the former pack to the new pack must be made available.

23. All bedside patient monitoring systems must include a detachable, interchangeable, mobile wireless transport monitor that will transmit all inputs of patient physiological vital signs and waveforms to the central server. A screen on the pack must be able to display at least HR, ECG 5 lead of choice, SPo2 concentration, NBP with MAP, and one pressure line input displayed simultaneously. Two waveforms must be available for display at one time. The monitor packs when detached for transport must transmit data via the telemetry infrastructure (Wi-Fi or WMTS) to the central server available for display and analysis on the central stations. All transmitted data will be recorded to the server and be available for view on the central monitoring and viewing stations. In case of wireless communication (Wi-Fi or WMTS) or facility power loss the monitor pack must operate and record internally for at least 2 hours.

24. All bedside monitor transport packs must have all input port options required for the ICU for full interoperability in all units throughout the hospital.

25. The system may utilize the facility AFNET based Wi-Fi network in order to eliminate the 88 MDG dependency on redundant infrastructure.

26. The monitoring system must also include enough core transport packs for all mounted monitors plus 2 additional units to be used in case of failure/repair.

27. The cardiac telemetry system must include 32 wearable patient cardiac telemetry packs that are capable of obtaining and transmitting: heart rate, 5 lead EKG, and SPo2 concentration to the central monitor and viewing stations from any point in the MTF with the requisite 72 hours of data storage.

28. All cardiac telemetry packs should have a minimum of 48 hours of runtime off a single charge.

29. The wireless communication (Wi-Fi or WMTS) enabled patient telemetry packs must have their own built in display capable of showing heart rate, at least 1 lead ECG (preferably lead #II), and SpO2. Each unit must be capable of displaying any two real-time wave forms with numeric data simultaneously

30. The central telemetry stations must provide the ability to view and alter patient demographics, alarms settings, data histories and trends, alarms and settings with ability to silence alarms.

31. The central monitor stations must also be able to communicate and export data to the EMR.

32. All units will be interconnected to offer cross-coverage of monitoring capability by any central monitoring or viewing station.

33. All patient monitoring equipment and related peripherals must be state-of-the-art technology. "State-of-the-art" is defined as the most current versions and/or recently designed components that are announced for marketing purposes, available, maintained and supported. Items with a manufacturer's planned obsolescence within the one year of delivery order issuance is not acceptable.

34. Delivery must be a phased approach that must last no more than 180 days from the order.

35. All system components designed for facility power infrastructure will be required to accept 120V/60 Hz power input at this facility.

36. Wall powered monitors and system core components must have surge protection and a battery backup system to mitigate data loss and operation loss due to power supply swaps to generator power.

37. Central Stations must be able to print patient data for all relevant providers including one thermal EKG strip printer for every central monitor screen located at the station and communication to an office type printer for each central monitor station.

38. Viewing stations must have one thermal EKG strip printer located at the station and communication to an office type printer.

39. Thermal printers must be able to print any two selected waveforms simultaneously.

40. Capability to print data from any wall monitor via import to the EMR must be provided.

41. When wall or bedside mounted, the monitors must be within 3 feet of the bed. The wall mounted units must have a detachable transport monitor to facilitate patient mobility and transport throughout the facility.

42. The monitors must include audible and visual alarms in accordance with national patient safety goals.

43. The ability to set alarm parameters for every data input must be available in order to set a minimum and maximum thresholds and have option to be silenced by the staff.

44. The telemetry and mobile monitor system must include rechargeable batteries with charging stations.

45. All bedside monitor transport packs must utilize a rechargeable battery pack with a nominal runtime of 2 hours.

46. The quote must include an initial supply of peripheral sensors: SPo2 Probes disposable adult (Qty 500) Pediatric (Qty 200) neonate (Qty 100) adult non-disposible (Qty 100), BP cuffs (Qty 200—30 Small, 50 Medium, 75 Large, 45 Extra Large), Pressure Transducer Cables (Qty (100), ECG 5 Cables (Qty 100), Temperature Probe Cables (Qty 50), ECG 12 Cables (may be extensions utilized with 5 lead cables (Qty 100)), Oral Thermometer probes (Qty 60) Core Temperature Probes (Qty 60). Also include 10 pediatric and 10 neonate in all sizes for BP cuffs, EKG leads (3 lead). Additional peripherals include: non-invasive hemodynamic monitoring pads (Qty 100), bispectral leads (Qty 20) train of four mechano-sensor and electro-sensor cables (Qty 20)

47. The bedside monitor and cardiac telemetry systems must have seamless compatibility with the CliniComp Interface, in order to update the Essentris® Electronic Medical Record (EMR). Required changes to software for bedside monitors must maintain the capabilities of full wave depiction for analysis (P, QRS & T) via an HL7 outbound interface to Essentris to capture data and import it into the patient record. Capability to change the HL7 EMR data interface must be made available to facilitate replacement of EMR systems at no cost to the government.

48. Data from transport monitors and/or telemetry monitors will also be made available for update to the EMR via the central monitoring system.

49. During the life cycle of this system, Wright Patterson’s CHCS, AHLTA, and Essentris will transition to Cerner as the new EHR and must be compatible with the bi-directional HL7 interface used with the Cerner Genesis EHR. In addition, the quote must provide all required interfaces requirements needed; including software, hardware and licensing; to ensure system compatibility for the expected service life.

50. The product must be established on the Cerner supported and certified medical device list.

51. The capability to transmit patient bedside monitor and EMR data to the VISN 23 Regional Telemedicine ICU System via secure connection must be provided. A web viewer interface must be installed on the central monitoring system server for the ICU in order to transmit patient monitor data to the MediCore servers in use by the VISN 23 Telemedicine ICU Center is in Minneapolis, MN.

52. The central monitoring stations must have access to all of the monitors and telemetry packs across the facility. Alarm settings shall remain independent to each station without altering other station alarm parameters.

53. Delivery and installation must be a phased approach that must last no more than 180 days from the order. Provide an implementation plan that includes a full timeline from order issuance to include lead time of equipment, shipping, site surveys, delivery, installation training, and go live date.

7. Maintainability/Maintenance Support:

54. Vendors must provide 2 BMET training slots in their quote. Onsite BMET training is strongly preferred.

55. Operators, Maintenance/Service, and Training manuals must be provided for every type of equipment with rights to reproduce and distribute within Wright Patterson, OH. One paper format and two digital format copies are required for each manual.

56. Vendors must provide a system schematic once the system is installed and a data workflow diagram.

57. Vendors must provide cleaning instructions.

58. The vendor will provide:

· Extended warranty greater than the minimum required

· Already developed interface or agreeing to partner with Cerner to develop a communication interface.

· Minimal variation in supplies/repair parts between monitor types.

8. Information Technology (IT):

59. The vendor must provide an HL7 interface to the CliniComp Intl system via IP and port number networking replacing the current hard LAN connection. TCP/IP connections must be secure in accordance with DOD cyber network regulations.

60. Any system with unsupported operating systems (i.e. Windows XP) is prohibited. Only equipment and part numbers that are FDA approved and commercially available at time of quote submission may be offered under this requirement. Promises to upgrade the system in the future to meet Government requirements such as providing a supported operating system or IA requirements is prohibited.

61. If the manufacturer must install software on end users computers, it must be capable of running on the DoD Windows 7 or higher standard desktop configuration platform.

62. If the manufacturer must install proprietary equipment, at a minimum, workstation operating systems will be Windows 7 or higher. If Windows based, the vendor must provide a plan and timeline to upgrade their system to Windows 10. The upgrade must be a no cost to the government.

63. The vendor must allow for unlimited site license for all current generation products (as quoted) including software and communication technologies, including mandatory software upgrades and updates. This includes all licensing required for proper system functionality, locally and remotely, for the life of the system. This includes but is not necessarily limited to the following list:

- Unlimited Monitor to Monitor

- Monitor to Central Station

- Central to Central Communication

- Unlimited Patient Data Transfer.

- All new components interfacing to the system.

64. All networking equipment must be mounted in a communication closet (see attachment for coverage area).

65. Networking equipment must be rack-mounted.

66. The server operating system must be Windows 10.

67. All supplied software, operating systems, databases, etc. (excluding vendor developed application software) must be on the National Information Assurance Partnership approved products list found at https:/niap-ccevs.org/ or https:/www.commoncriterisportal.org.

68. Vendor must provide proof that supplied software is on this approved list.

69. Required proof is a print screen from one of the web sites above.

70. The vendor must test OS patches and release them according to the IA requirements listed throughout the life cycle of the equipment.

71. The vendor must provide a listing of the equipment that will require an IP address.

9. Information Assurance (IA):

72. All system data must be safeguarded using the required security protocols established by the United States Air Force. Therefore, any offered system must meet DoD Cybersecurity and the attached Information Assurance (IA) requirements and meet RMF Risk Management Framework) requirements.

73. The system will be fully RMF certified no later than 30 days prior to installation.

74. ATO/ATC terminology is interchangeable with RMF.

75. All equipment and installation must comply with current HIPAA requirements to ensure privacy of patient information.

76. Vendors must have obtained permission from the Defense Health Agency (DHA) for Authority to Operate (ATO) or Authority to Operate with Conditions (ATO-C) and Authorization to Connect (ATC) on the DOD cyber network no later than the date of the submitted quote.

77. Product is undergoing a RMF effort and system is past Step 3 of RMF or has an existing RMF ATO.

10. General Requirements:

78. Vendors must provide go-live training and support for at least 2 weeks after the go-live date with super user training for 12 personnel.

79. At a minimum, vendors must provide a 1 year warranty for parts and labor which includes travel expenses, as well as 1 year preventative maintenance.

80. Vendors must ship direct to site and the price must be included in the quotes. Please ship to:

88 MDSS/SGSM c/o MEMO 4881 Sugar Maple Drive WPAFB, Ohio 45433 937-257-0524

11. Trade-in:

81. This order includes Trade-in of Government equipment. The trade-in will be incorporated into the order, including any applicable price reduction of the equipment price. The Government equipment items slated for trade-in must be de-installed by the contractor prior to initiation of installation of new equipment, and removed from the hospital. The hospital will remove the equipment from their property book at that time. The room must be left broom clean by the contractor after de-installation. Transfer of title must occur when the Vendor or its designee begins to de-install the equipment being traded in. At this point the trade-in price is final and must not be adjusted.

82. MERC and MEMO will clear the vendor to commence de-install for HIPPA requirements. De-install prior to clearance is prohibited.

83. The following are available for trade in: Current GE Central Monitoring, telemetry, and peripheral systems in Use at WPAFB.

12. Installation & Testing:

84. Portions of installation requiring facility modifications (e.g. installing mounting hardware, structural modifications. Infrastructure modifications…).

85. Portions of installation requiring patient or staff displacement must be “staggered” and be coordinated no less than 30 days in advance due to patient care.

86. Installation must be “Turn-Key” in that all work required for solution to be fully operationally capable is the responsibility of the vendor.

87. May be required to install evening or weekend.

88. Remove old patient monitoring solution.